From mpalmedo@cptech.org Mon Nov 1 06:38:00 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Mon Nov 1 06:38:00 2004 Subject: [Ip-health] AP on EU court case involving GSK's practice of limiting sales to prevent parallel trade in Europe Message-ID: <4182D5BE.1050002@cptech.org> http://www.e-topics.com/index.asp?layout=topic_story&UserID=20020904121936145733&topic=563&display=&doc_id=h1028031.5ap October 29, 2004 Top EU court adviser backs GlaxoSmithKline Associated Press BRUSSELS, Belgium: A top legal adviser at the European Court of Justice said Thursday that GlaxoSmithKline PLC and other major pharmaceutical companies can restrict some supplies of their patented medicines in Europe. The advice of Advocate General Francis Jacobs still has to be confirmed by a court ruling later for it to stand. Drug wholesalers in Greece were making substantial profits by repackaging prescription drugs and selling them in other EU countries where national governments assign higher costs to the same products. To halt this practice, in 2000 Glaxo began limiting the quantities of wholesale orders. Greek and European regulators questioned whether Glaxo, the world's second-largest drug company, was abusing its dominant role in the pharmaceutical industry and violating EU competition laws. Thursday's opinion could give the pharmaceutical industry a stronger hand in stopping so-called parallel trading that affects profits and is worth about ?4.5 billion (US$ 5.75 billion) a year. The trade also is an issue in the U.S. presidential race, where some citizens are clamoring for cheaper medicines from Canada. Jacobs' opinion stated that the wide variance in drug prices among EU member countries and the regulatory nature of the prescription drug industry create an environment where typical competition rules do not apply. He said restricting product supply is not automatically an abuse, as long as the pharmaceutical manufacturer is providing enough of its product to meet the country's legitimate needs. Glaxo is entitled to take measures that "are reasonable in order to defend its commercial interests," Jacobs said. He also noted that his verdict was "highly specific to the pharmaceutical industry" and should not be applied elsewhere. The opinion by the Advocate General of the European Union's top court is a critical stage in a long-running battle between big pharmaceutical companies and the traders. Ten months earlier, the same court allowed German drug giant Bayer AG to maintain a similar quota system. The court's advocates general's opinions are followed a few months later by the full court in about 80 percent of cases. From pdavis@healthgap.org Mon Nov 1 06:38:23 2004 From: pdavis@healthgap.org (Paul Davis) Date: Mon Nov 1 06:38:23 2004 Subject: [Ip-health] Reuters: AIDS Fund Head Warns of 2005 Funding Crunch In-Reply-To: <004301c4bdeb$f43450d0$bc01a8c0@gaa.local> Message-ID: Reuters October 28, 2004 AIDS Fund Head Warns of 2005 Funding Crunch By Ben Hirschler BARCELONA (Reuters) - The Global Fund to Fight AIDS, Tuberculosis and Malaria, battling a shortfall in funding from donors, faces a critical year in 2005, its executive director said on Thursday. Lack of cash means it is still unclear whether a new round of project funding against the three killers will be approved when the groups board meets in Arusha, Tanzania, on Nov. 17-19. Richard Feachem said failure to act would be disastrous. "The danger facing the Global Fund is that the board will decide not to launch a Round Five next year. Zero rounds in 2005 would be a catastrophe," he said in an interview while attending an international pharmaceutical industry meeting in Spain. "It would be a major loss of momentum for the worlds new financing mechanism against AIDS, TB and malaria and a betrayal of the vision and the trust and the hope that is placed in the Global Fund." The fund needs at least $2.5 billion to carry out its work in 2005, up from $1.5 billion this year, but so far has secured only around $1.6 billion. There is likely to be a carryover of some $200 million from 2004, but commitments under existing programs will eat up $1.3 billion in 2005. That means just $500 million may be left for new funding initiatives - half the amount of previous rounds at a time when investment should be accelerating sharply. "We never thought it would be easy and the transition from 2004 to 2005, from $1.5 billion to $2.5 billion, is particularly challenging," Feachem said. He still hopes governments will dig deep to provide new funds, especially after a meeting of G8 leaders of industrialized countries next July at Gleneagles, Scotland. The G8 declared in 2003 that the Global Fund should get $3 billion a year, with French President Jacques Chirac proposing $1 billion from Europe, $1 billion from the United States and $1 billion from other countries. But donations to the Geneva-based public-private partnership have fallen short of such pledges, amid tensions between Washington and other governments over the best way of tackling AIDS. More than half of the money committed by the fund so far to some 300 programs in 130 countries goes to fight HIV/AIDS, which has killed 20 million people in the past two decades and infected nearly twice that number. U.S. Global AIDS Coordinator Randall Tobias said in August he would hold back $120 million of this years promised donations to the fund because others donors had not contributed their share. Since then, several countries have contributed more and Feachem said he hoped the fund would receive some - though not all - of the retained U.S. Money. From joaninha@comcast.net Mon Nov 1 06:38:29 2004 From: joaninha@comcast.net (Joana Ramos) Date: Mon Nov 1 06:38:29 2004 Subject: [Ip-health] Could Indian drugmakers TRIP on patent reform? Message-ID: <418465A5.3000108@comcast.net> From: IMS Health http://www.ims-global.com/insight/news_story/0410/news_story_041027.htm 27 October 2004 > Could Indian drugmakers TRIP on patent reform? > > The Indian pharmaceutical market is due for a paradigm shift on > January 1st 2005, when the country falls into line with the World > Trade Organisation's TRIPs (Trade-Related aspects of Intellectual > Property rights) agreement, which provides for minimal patent > protection. The new regime will close down the one opportunity that > allowed most Indian drug manufacturers to flourish - reverse > engineering..... note discussion this article contains on the EMR cases, the first of which was for Glivec: > EMRs cause a furore > > One of the precursors to TRIPs has been the granting of EMRs > (exclusive marketing rights). Applications for EMRs can be made for > new drugs not in the public domain that receive marketing approval in > India before the end of the 10-year transitional period in 2005, and > usually provide a five-year exclusivity period; they will expire if a > product patent is later granted. > > After much delay, the first EMR was finally granted in October 2003, > to Novartis for its chronic myeloid leukaemia drug Glivec (imatinib > mesylate). Novartis applied for the EMR in 1998, and received > marketing approval for Glivec (Gleevec) in India in 2001. By the time > the EMR was granted, a number of Indian manufacturers had launched > generic imatinib. > > The domestic firms did not take the matter lying down. Drugmaker Natco > and the IDMA (Indian Drug Manufacturers=92 Association) claimed that > Glivec=92s patents were filed before 1995, invalidating its eligibility > for EMR. Furthermore, the IDMA believes that even if the EMR is valid, > the government should grant compulsory licences for generic copies on > the grounds of public interest; a year=92s therapy with Glivec costs > around $27,000, compared with $2,700 for Natco=92s Veenat imatinib produc= t. > > Novartis obtained an injunction from the High Court in Madras, > restraining six domestic drugmakers from manufacturing imatinib, but > not Natco; it also claimed "token" damages in the region of Rs1 > million ($22,000). Four have cooperated and withdrawn imatinib, but a > case in Chennai is ongoing, as are appeals against the Glivec EMR, and > at least three generic versions of imatinib were still being sold as > of September 2004. > > Controller General loses job > > One of the more extreme ramifications of the first EMR was the > replacement of SN Maitu as Controller General of Patents and > Trademarks on September 1st 2004. An official from the Ministry of > Industry and Commerce stated: "There have been reports of > irregularities in the official=92s functioning. Apart from the EMR > issue, which is sub judice, many allegations have cropped up on his > trademark-related decisions also." > ...... -- Joana Ramos, MSW Cancer Resources & Advocacy 7303 23rd Ave. NE Seattle, WA 98115 206-229-2420 http://home.comcast.net/~farpost3/cancer/ From bulletin@who.int Mon Nov 1 10:40:02 2004 From: bulletin@who.int (bulletin@who.int) Date: Mon Nov 1 10:40:02 2004 Subject: [Ip-health] Email alert: November issue of the Bulletin Message-ID: <500752877A5A1440BA50AB3292372F9D0DD3E949@whqkaki01.who.int> This message is in MIME format. Since your mail reader does not understand this format, some or all of this message may not be legible. -- [ Picked text/plain from multipart/alternative ] Dear Reader, With this e-mail you are receiving the table of contents of the latest issu= e of the Bulletin of the World Health Organization which has just been published on our website at http://www.who.int/bulletin/en/ . To go to the November table of contents, click on the following link: http://www.who.int/bulletin/volumes/82/11/en/ or to access the articles directly, click on the links provided below. If you would like to comment o= n any of these articles please email your comments to: bulletin@who.int identifying the article you wish you comment on by manuscript number or author and issue. After quick editorial review, these comments may be poste= d on the Bulletin's web site under our "Bulletin board" section and a selection will be chosen to appear in the print version of the journal. Volume 82, Number 11, November 2004, 811-890 IN THIS MONTH'S BULLETIN - [pdf 54Kb] Glaucoma now leading cause of blindness; Sex inequality hampers fight against AIDS; Do poor countries make the most of TRIPS?; Reporting adverse vaccine reactions; Treatment gap for mental health care EDITORIALS Correcting gender inequalities is central to controlling HIV/AIDS Olive Shisana & Alicia Davids - [pdf 56Kb] - Text in HTML A fair deal for the future: flexibilities under TRIPS Anthony D. So - [pdf 61Kb] - Text in HTML A dialogue on chemicals and children Roberto Bertollini & Marc Danzon - [pdf 52Kb] - Text in HTML RESEARCH TRIPS Agreement and public health Maria Auxiliadora Oliveira, Jorge Antonio Zepeda Bermudez, Gabriela Costa Chaves, & Germ=E1n Vel=E1squez - [pdf 228Kb] -with Arabic summary [pdf 660Kb] - Abstract [HTML] Decentralization and health system Sarah Atkinson & Dave Haran - [pdf 225Kb] - wit= h Arabic summary [pdf 741Kb] - Abstract [HTML] Vaccinovigilance in Europe - requirements Kari S. Lankinen, Satu Pastila, Terhi Kilpi, Hanna Nohynek, P. Helena M=E4kel=E4, & Patrick Olin - [pdf 206Kb] - wit= h Arabic summary [pdf 521Kb] - Abstract [HTML] Tuberculosis among tribal population of Car Nicobar Island, India M.V. Murhekar, C. Kolappan, P.G. Gopi, A.K. Chakraborty, & S.C. Sehgal - [pdf 236Kb] - wit= h Arabic summary [pdf 521Kb] - Abstract [HTML] POLICY & PRACTICE Visual impairment in 2002 Serge Resnikoff, Donatella Pascolini, Daniel Etya'ale, Ivo Kocur, Ramachandra Pararajasegaram, Gopal P. Pokharel, & Silvio P. Mariotti - [pdf 223Kb] - wit= h Arabic summary [pdf 577Kb] - Abstract [HMTL] Laboratory confirmation of measles in low-transmission settings Vance Dietz, Jennifer Rota, H=E9ctor Izurieta, Peter Carrasco, & William Bellini - [pdf 166Kb] - wit= h Arabic summary [pdf 504Kb] - Abstract [HTML] The treatment gap in mental health care Robert Kohn, Shekhar Saxena, Itzhak Levav, & Benedetto Saraceno - [pdf 374Kb] - wit= h Arabic summary [pdf 634Kb] - Abstract [HTML] Health information technology in developing countries Elaine Tomasi, Luiz Augusto Facchini, & Maria de Fatima Santos Maia - [pdf 220Kb] - wit= h Arabic summary [pdf 474Kb] - Abstract [HTML] Noncommunicable disease in the Russian Federation Marya Levintova & Thomas Novotny - [pdf 220Kb] - wit= h Arabic summary [pdf 474Kb] - Abstract [HTML] LETTERS Community participation in health care Morshed Chowdhury - [pdf 56Kb] - Text in HTML BOOKS & ELECTRONIC MEDIA Accessing health care: responding to diversity - Kassem Kassak - [pdf 83Kb] NEWS News stories: Donors pledge more than US$ 120 million to aid hurricane-hit Caribbean islands; Drive to produce more long-lasting insecticidal mosquito nets for malaria; Darfur overshadows "forgotten" crisis in neighbouring Uganda - [pdf 201Kb] In focus feature: Glaucoma is second leading cause of blindness globally - [pdf 54Kb] - [HTML] WHO News stories: WHO launches global patient safety campaign; WHO's where in October; Expert= s raise alarm over measles in Europe; WHO steps up TB-AIDS collaboration; Largest ever polio vaccination campaign - [pdf 232Kb] To remove your name from our mailing list, please send an e-mail to: bulletin@who.int and insert "TOC unsubscribe" in the subject header. From sean.flynn@spiegelmcd.com Mon Nov 1 10:40:10 2004 From: sean.flynn@spiegelmcd.com (Flynn, Sean M.) Date: Mon Nov 1 10:40:10 2004 Subject: [Ip-health] Averting Vaccine Shortage Message-ID: <29EF3836241AF34CA5CCCB8168CB7798033ACD0D@smexchange.smcdomain.com> Now posted on www.antitrustinstitute.org: October 29, 2004 Could the U.S. Government Have Prevented the Flu Vaccine Shortage? An Indus= trial Organization Perspective In a press release accompanying AAI Working Paper #04-03 by F.M. Scherer, A= AI President Albert Foer discusses policy considerations that appear to flo= w from Dr. Scherer's paper. October 29, 2004 AAI Working Paper 04-03. An Industrial Organization Perspective on the Infl= uenza Vaccine Shortage, by F. M. Scherer In this Working Paper, AAI Senior Fellow F.M. Scherer examines various reas= ons advanced for the current shortage of flu vaccine in the U.S., finding t= hat multiple sourcing with excess capacity built-in would yield more benefi= ts than it costs. From mbailey@Oxfam.org.uk Mon Nov 1 13:29:02 2004 From: mbailey@Oxfam.org.uk (mbailey@Oxfam.org.uk) Date: Mon Nov 1 13:29:02 2004 Subject: [Ip-health] Access to medicines: EC new regulation plus oxfam press release Message-ID: -- Hi I sent this to Jamie on Friday for posting but not sure if it got through best wishes Michael Michael Bailey Trade and Investment Team Leader Policy Department Direct: +44 1865 312494 Mobile: +44 7968 196102 Here is the press release we put out 29th nov on the draft EU regulation on generic drug exports. You will also find attached the regulation itself. START EC gives positive signal on access to cheap medicines Brussels, Belgium: Oxfam welcomes today's publication of a new EC draft regulation on patents and access to medicines. Europe is sending a positive political signal to developing countries that they can override patents to gain access to cheaper generic medicines, vital to combating deadly and debilitating diseases. "With 14 million people dying every year from infectious diseases, it is essential that developing countries feel confident about supplying cheaper generic medicines to their citizens in the face of hostility from the giant drug companies and the United States government" said Michael Bailey of Oxfam. The new regulation will give European governments the legal right to suspend drug patents to allow European manufacturers to export cheaper generic versions to developing countries. This change in law follows a decision at the WTO in August last year to lift restrictions on the export of generics. However, Oxfam warned that the change to WTO, and now European, patent rules is not a panacea for bringing down the price of essential medicines. "The legal mechanism agreed by the WTO is complex, and even if a developing country fights through the red tape, its market may not be large enough to allow generic companies to offer lower prices" said Bailey. The European Commission and the World Health Organisation will need to monitor carefully how this legislative change works in practice, across the full range of diseases affecting developing countries. Oxfam considers that the EC draft is a 'good faith' interpretation of the WTO's August 2003 agreement to change TRIPS. However, one important improvement is possible: in the event of a public health emergency in a developing country, European governments should not require potentially time-consuming negotiations with the patent-holder before issuing a compulsory licence for export. "The longer term solution is for generic production to be the norm in developing countries, not the exception" says Bailey, "which means major reforms of TRIPS, the WTO patent treaty". Competition from Indian generics brought the price of anti-retrovirals in Africa down from $10,000 per patient per year to under $200, which opens the door to saving millions of lives, but from 1st January 2005, TRIPS will stop India from routinely manufacturing and exporting generic versions of new drugs. Infectious diseases sweeping Africa and the growing impact of non-communicable illnesses such as cancer and heart disease in all developing countries mean that access to medicines and health care should be at the top of the global political agenda. Oxfam believes that the positive message from the European Commission today is that these public health imperatives must outweigh the commercial interests of the large drug companies. For more information Louis Belanger, Oxfam International Media Officer, Mobile +32 4 73 562 260 Note to editors: The draft EU regulation amends a rule which says that governments can only suspend a patent on a medicine and authorise the production of a generic version, a process known as compulsory licencing, if it is destined largely for the domestic market. This meant that the vast majority of developing countries, who do not have sophisticated manufacturing capacity, either have to pay the high price of imported patented medicines, or, more likely given their lack of resources, go without. The regulation will now be debated by the member states and submitted for approval to the European Parliament early next year. The initial decision to change this global rule was taken at the 2001 WTO Ministerial Conference in the landmark 'Doha Declaration on TRIPS and Public Health'. Despite intense opposition from the United States, the Declaration stated clearly that developing countries can override patents on public health grounds that they themselves define. END (See attached file: PR on EU patent amendment 29-10-04.doc)(See attached file: Regulation compulsory licencing.pdf) Oxfam works with others to find lasting solutions to poverty and suffering. Oxfam GB is a member of Oxfam International, a company limited by guarantee and registered in England No. 612172. Registered office: 274 Banbury Road, Oxford OX2 7DZ. Registered charity No. 202918. Visit the web site at http://www.oxfam.org.uk A catastrophe is unfolding in Darfur in Western Sudan. Thousands of people have been killed, and over one million people have been driven from their homes. The international community needs to do more. To find out more, to donate, and to take action visit: http://www.oxfam.org.uk/sudanemergency -- [ PR on EU patent amendment 29-10-04.doc of type application/msword deleted ] -- [ Regulation compulsory licencing.pdf of type application/pdf deleted ] -- From relliott@aidslaw.ca Mon Nov 1 13:30:30 2004 From: relliott@aidslaw.ca (Richard Elliott) Date: Mon Nov 1 13:30:30 2004 Subject: [Ip-health] Doha para 6 implementation: EU proposal vs. Canadian legislation Message-ID: <6.1.2.0.2.20041101102222.02836860@mail.aidslaw.ca> -- [ Picked text/plain from multipart/alternative ] For those following the implementation of the WTO General Council Decision of 30 August 2003, I did a quick comparative analysis of how the EU's proposed regulation, released last Friday, compares to the Canadian legislation passed earlier this year, since so far these are the most detailed examples of implementation (by countries that are potential exporters of generic pharmaceutical products). I will leave it to someone else to compare these against the Norwegian regulations, also promulgated earlier this year, but which are less detailed than either the Canadian law or the EU proposal. Below is a modified version of an analysis shared with Canadian civil society groups following this issue. No doubt other aspects of the EU proposal warrant comment, that will be forthcoming from others on the list. EU proposal to implement legislation similar to Canada's Bill C-9 On Friday, 29 October 2004, the European Union released the text of its proposed regulation that would implement the August 2003 decision of the WTO to loosen patent rules so that compulsory licences can be issued on pharmaceutical products to permit the export of cheaper generic versions to countries needing them to address public health problems. This is the EU's version of what in Canada took the form of Bill C-9, which was passed by Parliament in May 2004 and is expected to come into force sometime around January 2005, once the regulations to accompany the statute have been finalized, following the current period of public comment. To the best of my knowledge, to date Norway is the only other potential exporting country to have taken steps to implement the WTO decision. On the same day that Parliament passed Bill C-9 in Canada, the Norwegian government promulgated regulations providing a basis in Norwegian law for compulsory licensing of pharmaceuticals for export, in accordance with the WTO decision. The full text of the EU proposal is available via: http://europa.eu.int/comm/trade/issues/global/medecine/pr291004_en.htm [English] http://europa.eu.int/comm/trade/issues/global/medecine/pr291004_fr.htm [fran=E7ais] How does the EU proposal compare to the Canadian legislation? In the process of drafting and enacting Bill C-9, Canadian civil society organizations raised numerous concerns and engaged in sustained advocacy to improve what was a seriously flawed bill. Those efforts led to some significant improvements in the bill, although the final text retains several deficiencies that should be remedied. The Canadian HIV/AIDS Legal Network, and other civil society groups, have stressed that the Canadian legislation is an example that should be studied, both for its positive features and to avoid replicating its remaining flaws when embarking on similar initiatives in other countries. So, how does the EU proposal, as currently drafted, compare to the Canadian law? (1) Pharmaceutical products which may be subject to compulsory licence Canadian civil society advocates have heavily criticized the Canadian government for unnecessarily and unjustifiably limiting the scope of Bill C-9 by including in the law a limited initial list of pharmaceutical products for which a generic manufacturer may obtain a compulsory licence to permit production and export. Such an approach of limiting the diseases or medicines which developing countries could import in generic form was emphatically rejected in WTO negotiations that led to the decision that Bill C-9 was supposed to implement. Canada's introduction of such a list is a demonstration of bad faith in implementing a bitterly negotiated international consensus. The inclusion of such a list opens the door for patent-holding pharmaceutical companies to lobby against the addition of any further medicines or products to the list. Indeed, this has already happened, even before the bill was passed by Parliament. And the government itself has already reneged on its repeated promises that the list would not be used to limit the law to just medicines for HIV/AIDS, TB or malaria or just medicines on the World Health Organization's Model List of Essential Medicines (on which the Bill C-9 list is based), by voting against the addition of other medicines (including ones used to treat people living with HIV/AIDS). The EU proposal is far superior to the Canadian legislation on this front. It does not contain a limiting list. Rather, it contains an open-ended definition of "pharmaceutical product". (2) Countries to which medicines may be exported The EU proposal would only allow for export of generic pharmaceuticals, produced under compulsory licence in an EU country, to countries that are WTO Members. This is less expansive than the Canadian legislation, which will allow the export of medicines to a country that is not a WTO Member if either (a) it is recognized by the UN as a "least-developed country" (LDC), or (b) it is a developing country that is eligible for "official development assistance" according to a list maintained by the Organization for Economic Cooperation & Development (OECD) that declares it is facing an "emergency or other circumstance of extreme urgency". (This emergency requirement is unjustified and unsound: it does not apply to developing countries who belong to the WTO, so there is little reason that it should apply to non-WTO countries.) The EU regulation is deficient as long as it limits exports just to other WTO Members. It should be expanded to include all least-developed and developing countries, whether they belong to the WTO or not. And, unlike the Canadian law, it should not re-assert the limitation that countries can only import generic medicines in cases of "emergency". This restriction was rightly criticized as unethical and as unsound public health policy during the negotiations leading up to the WTO decision in August 2003 that these measures are intended to implement. Developing countries flatly rejected such a limitation, and the final decision does not include any such limitation. There is no justification for re-introducing it now and applying it to developing countries on the basis that they are not WTO memb= ers. (3) Notification of parallel applications The EU proposal requires that a generic pharmaceutical manufacturer must, when applying for a compulsory license on a product in one EU country, also provide information about any other applications regarding the same product that it is submitting in any other EU country. The stated rationale is that this is "to avoid facilitating overproduction and possible diversion" of generic medicines. This is a feature peculiar to the EU supra-national structure. Quaere whether this is really necessary; the concern that it ostensibly addresses is likely overstated, and it is more likely to be an additional administrative inconvenience for generic producers. (4) No possibility of NGO procurement from generic producers Under the EU proposal, the generic producer applying for a compulsory licence has to submit evidence of a specific request for the pharmaceutical product in question "from authorised representatives" of the importing country, "indicating quantity of product required." This likely means that only governments of importing developing countries can purchase products from generic manufacturers. Non-governmental organizations (NGOs), such as humanitarian organizations operating health care services and delivering treatment cannot contract with generic producers in EU countries to obtain needed products, unless those NGO are "authorised representatives" of the government in question. De facto, this is similar (although worse) than a limitation that ultimately made its way into Canada's Bill C-9. Civil society groups argued to the Canadian government that cutting NGOs out in this way was unnecessary, undesirable and unjustifiable. They pointed out that NGOs are already purchasing medicines, for use in their programs, from both brand-name and generic manufacturers, so why would this avenue to obtaining cheaper medicines for their patients be cut off? They also stressed the importance of non-governmental organizations maintaining their independence from government; that they could not accept being "agents" of government, as this would compromise not only their independence, but also their effectiveness. (It was also pointed out that clearly maintaining independence from government was particularly important to some NGOs, whose personnel could be at greater risk if they were perceived as government agents). Eventually, the Canadian government accepted this submission and amended Bill C-9 accordingly. Sadly, the government permitted a Liberal MP to re-introduce a further amendment that re-imposed a condition that any NGO wishing to purchase generic medicines produced under compulsory licence by a Canadian manufacturer would need to get the "permission" of the government of the importing country. This significantly weakened the Martin government's own changes that had responded to NGOs concerns. Nonetheless, they allowed it to stand in the final text of Bill C-9. Unfortunately, the EU proposal's language of "authorized representatives" seems to represent a similarly narrow approach. The EU regulation could definitely improve on the Canadian model, on this front, if it were to take a more expansive approach and not limit contracts with generic producers solely to governments or their "authorised" agents/representatives. (5) Requirement to first seek a voluntary licence from patent-holder Under WTO rules, before a compulsory licence may be issued, first the generic producer must attempt to negotiate a voluntary licence with the patent-holder "on reasonable commercial terms and conditions". If those efforts do not succeed "within a reasonable period of time", then a compulsory licence (ie, without the consent of the patent holder), and the competent authority that issues the compulsory licence will fix the terms and conditions (such as the amount of the "adequate remuneration" that must be paid to the patent-holder). These terms are not more precisely defined in WTO rules, and it is up to individual WTO Members as to how they implement this in their own laws. Canada's Bill C-9 is reasonably good in its approach to implementing this requirement. It specifies that 30 days is the "reasonable period of time" during which the generic producer must make efforts to obtain a voluntary licence from the patent holder on reasonable terms. After that time, the Canadian Commissioner of Patents "shall" issue a compulsory licence if all the other requirements of the law are met. (It would, of course, be desirable to shorten this period even further, eg, to 7 or 15 days, but nonetheless 30 days is not bad.) Canada's law is also positive in that it is expected to set out a formula for calculating the royalty rate that needs to be paid in the event that a Commissioner issues a compulsory licensing: it provides a sliding scale, with the royalty rate directly tied to the ranking of the importing country on the UN's "Human Development Index", which reflects such things as per capita income. The overall effective cap is a maximum royalty of 4%; most developing countries will pay considerably less than this. By setting out what is deemed "adequate remuneration" in the event of a compulsory licence, the law de facto signals what is a "reasonable" rate that the generic company and the patent-holding company should be able to agree to in negotiating the terms of a voluntary licence during the 30 day negotiation period. (There may be better approaches than linking royalty rates to the UN HDI, but it is certainly a reasonable approach that correlates, at least in some rough way, the ability of a country to pay with the royalty in question, and it provides certainty.) By contrast, the EU regulation is dangerously vague on these points. It does not provide any guidance as to what is a "reasonable term and condition" of a licence, nor as to what constitutes a "reasonable period of time" for trying to negotiate a voluntary licence before the way is clear to applying for a compulsory licence. It simply repeats the undefined terms from the original WTO agreement. This kind of uncertainty constitutes a major disincentive to any generic manufacturer. It inspires little confidence that the generic pharmaceutical industry would respond by spending time and money to use such a system to obtain licences permitting them to export their products to countries that will already provide far lower profit margins than concentrating on high-income country markets. On this front, the EU regulation requires significant improvement. (Perhaps national patent laws of EU member countries can address this shortcoming by specifying the negotiating period and royalties payable in the event of compulsory licensi= ng.) (6) Opportunities for legal harassment of generic pharmaceutical producers The Canadian law contains a provision allowing a patent-holder to claim that a generic manufacturer's contract with a purchaser of pharmaceuticals is too "commercial" in nature, because it exceeds certain price or profit caps that are found in the law. This provides an opportunity for vexatious litigation against generic producers, as a further disincentive to using this system. (If, after court-supervised investigation, it is found that the generic producer is charging too high a price or making too much profit, the compulsory licence that was issued can be revoked.) This provision is unnecessary and should be removed from the Canadian law. The EU proposal does not contain such a provision; in this respect it is better than the Canadian approach. (Both the Canadian and EU measures contain provisions for terminating a compulsory licence if its conditions are not respected.) However, the EU proposal does contain some explicit provisions for "detention and disposal" of product "where there is reason to suspect" that it is being re-imported into the European Community contrary to the terms of a compulsory licence. This term could be overly vague and broad, inviting allegations of re-importation in order to create additional inconvenience for generic producers. How it is interpreted and applied will determine whether it has such an effect. Firmer, more defined grounds for triggering such interventions would be preferable, to minimize the potential for abuse. (7) Regulatory review of generic product Before a drug can be marketed in Canada, it must go through a review process, governed by detailed regulations and policies, to assess its safety, quality and efficacy. Before Bill C-9, Canadian law did not require that a drug manufactured for export be subject to the regulatory review regulations and process administered by Health Canada's Therapeutic Products Directorate. However, Bill C-9 has imposed these requirements specifically on any pharmaceutical product manufactured for export under compulsory licence (and only on these products). Generic producers selling, in Canada, versions of existing products that have already been approved for sale in Canada ("Canadian reference product") usually need only go through an abbreviated review process demonstrating the equivalence of their generic formulation to the already-approved brand-name product. But in the case where there is no "reference product" approved in Canada, insisting that a generic drug for export, manufactured under a Bill C-9 compulsory licence, go through the full regulatory process poses additional challenges. This is the case, for example, with numerous "fixed dose combination" (FDC) ARVs for treating people living with HIV/AIDS that combine multiple products in one pill, thereby facilitating adherence to ARV regimens; these are among the "first-line" therapies recommended by the WHO as part of its initiative to dramatically scale up access to treatment in developing countries. But few FDC ARVs have been approved for sale in Canada, because they combine drugs which are patented by different, competitor brand-name companies. Overcoming this regulatory hurdle, in a way that adequately protects patient safety while at the same time making the system work for some of the most-needed pharmaceutical products, is a challenge that Health Canada must now face in finalizing regulations to accompany Bill C-9 and ensuring its policies and review practices are sufficiently flexible. Unlike the Canadian approach, which absolutely mandates this kind of regulatory review, the EU proposal provides that a generic producer "may" avail itself of the "scientific opinion procedure" provided for under a separate EC Regulation, "or any similar procedure provided under national law" (of an EU country). While the Canadian approach is mandatory, the EU approach is permissive. Conclusion The proposed EU regulation is better than the Canadian legislation in that it does not include a limited list of pharmaceutical products. But the proposed EU regulation is worse in that: (i) it does not recognize the needs of non-WTO developing countries; and (ii) it provides no clear definition of how long a generic manufacturer must attempt to negotiate a voluntary licence before a compulsory licence may be issued, nor any certainty about the royalties to be paid in the event of compulsory licensing. There is certainly considerable room to improve the EU proposal, and to produce a regulation that is better than the Canadian approach. At the moment, they each have flaws that should be remedied. Richard Elliott Richard Elliott Director, Legal Research & Policy / Directeur, politiques et recherche juridique Canadian HIV/AIDS Legal Network / R=E9seau juridique canadien VIH/sida 890 Yonge Street, Suite 700 Toronto, Canada M4W 3P4 Tel : +1 (416) 595-1666 Fax +1 (416) 595-0094 E-mail: relliott@aidslaw.ca Web: www.aidslaw.ca The Canadian HIV/AIDS Legal Network is a partner organisation of the AIDS Law Project of South Africa, and a non-governmental organization in Special Consultative Status with the Economic and Social Council of the United Nations. // Le R=E9seau juridique canadien VIH/sida est un organisme partenaire du AID= S Law Project de l'Afrique du Sud et ONG dot=E9 de statut consultatif sp=E9cial aupr=E8s = du Conseil =E9conomique et social des Nations Unies. ____________________________________________________________________ -- From wim.deceukelaire@intal.be Tue Nov 2 15:15:05 2004 From: wim.deceukelaire@intal.be (Wim De Ceukelaire) Date: Tue Nov 2 15:15:05 2004 Subject: [Ip-health] Draft Bill of Korean Legislation for the Grant of Compulsory License for Exporting Pharmaceutical Products Message-ID: <4186F1A3.2020606@intal.be> I'm forwarding a request from a friend of mine who is involved in the struggle for the right to health in Korea. Please consider how you can help these Korean health activists lobby for improved patent legislation. You can contact them through mdclara@korea.com. In solidarity, Wim De Ceukelaire ------------------ Dear Friends, I am writing this letter on behalf of the KFHR and activists of S. Korea. The KFHR(Korean Federation of Medical Groups for Health Rights) is a progressive NGO of Medical Doctors, Dentists, Pharmacists, Medical Workers, and Activists who are concerned of Health Rights. The Korean National Assembly is now having debates on the amendment of the patent law, and small number of people who are interested in patent law and accessibility to medicine are working on this issue. Our group and some progressive politicians have made a proposal of the bill, and it is to be debated early next month. What we need is, comments or statements supporting our bill from many activists and NGOs by 5th of November. We need your support because the power of politicians supportging the other proposal is so strong, and they are supported by powerful multinational corporations and scholars. So we need some voice that our proposal is a demand that could be universally accepted to achieve health right. I will attach our proposed bill with this email to help your understanding. Can you help us by sending your supporting email to me(mdclara@korea.com ), and ask your group to support us? In solidarity, Clara Kim, MD International Contactant of the KFHR --- Draft Bill of Korean Legislation for the Grant of Compulsory License for Exporting Pharmaceutical Products September 21, 2004 Written by HeeSeob Nam (heeseob_n@yahoo.co.kr nam@horizonlaw.com) Underlying Procedure for the Grant of a Compulsory License: l The proposed legislation provides for the applicant to seek the granting of a compulsory license through the established patent court system. The court of first instance is the Intellectual Property Tribunal of the Korea Intellectual Property Office. An appeal of the decision of the Intellectual Property Tribunal rendered by a trial board consisting of three trial examiners may be lodged with the Patent Court (High court) and then the Supreme Court of Korea. Applicant and Pharmaceutical Product: l Anyone who intends to export pharmaceutical products to an Importing Country (as defined below) may request for the granting of a compulsory license. The term =93Importing Country=94 shall mean (A) an LDC designated by the UN; (B) a non-LDC WTO member; or (C) a non WTO member. l The same definition for the term =93pharmaceutical products=94 adopted by WTO General Counsel=92s decision is adopted. l The right to seek a compulsory license described above applies to all products within the scope of the term =93pharmaceutical products=94 without exception. Contents of Application and Documents to be Submitted by the Applicant: l The applicant shall set out in the application form: (A) the name and quantity of the pharmaceutical product; (B) list of the Importing Countries; (C) the name of the patentee and the patent number; and (D) compensation to be paid to the patentee. The Presiding Trial Examiner can request the patentee to submit additional information if there are any further patents or patent applications related to the product not initially specified by the applicant. l The applicant has to submit documents showing: (A) that the Importing Country has insufficient or no capacity for the production of the pharmaceutical product in case the Importing Country is not an LDC; (B-1) that the Importing Country has submitted a notification to the Council for TRIPS under Paragraph 2(a) of the Decision of General Council of 30 August 2003; (B-2) that the Importing Country submitted a notification to the Minister of Foreign Affair in the prescribed form; (C) the specific packaging or labeling of the product; (D) the address of the website at which the contents of the compulsory license will be posted; and (E) that the applicant had, at least thirty days before filing the application, sought from the patentee a license to manufacture and sell the pharmaceutical product for export to the Importing Country and that such efforts had not been successful. The applicant can supplement the documents set forth in above (A) to (E) even after the application has been filed. The requirement of negotiating with the patentee set forth in (E) above is deemed to have been met if the Importing Country has notified that it will permit the use of the concerned patent (i) due to national emergency or other circumstances of extreme urgency, (ii) for public non-commercial use, or (iii) to remedy a practice determined after judicial or administrative process to be anti-competitive. Trial Decision: l A decision will be rendered within thirty (/30/) days after the applicant has submitted all of the required documents. l The decision shall set out: (A) the name and quantity of the pharmaceutical product; (B) the list of the Importing Countries; (C) the patent number; (D) the consideration to be paid to the patentee and the method of payment; (E) specific packaging or labeling of the product; and (F) a the address of the website at which the contents of the compulsory license will be posted. Compensation: l The compensation to be paid by the licensee to the patentee is determined by the following formula: (sales quantity) x (price per unit) x (contribution rate) x (basic rate) where sales quantity refers to the aggregate quantity of the pharmaceutical product exported each year to the Importing Country, price per unit is the average price of the pharmaceutical product in the Importing Country calculated each year, contribution rate is the ratio of the patent used in the manufacture of the product, and basic rate is 4%. The basic rate may be adjusted within plus or minus 2% in consideration of the innovative nature of the patent and economic value in the Importing Country. When the compensation cannot be determined by the formula, the Trial Board can determine the appropriate compensation to be paid based on its consideration of the economic value of the patent, prices of the Importing Country and the international humanitarian interest. However, the compensation cannot exceed 6% of net price of the product in the Importing Country. l Even if a patentee does not agree to the compensation, the patentee cannot appeal the grant of a compulsory license based on such compensation. Obligations of the Licensee and Cancellation of the Compulsory License: l The licensee shall: (A) not export the product in excess of the quantity set forth in the trial decision; (B) not export the product to any countries other than as set forth in the trial decision; (C) not use different packaging and labeling of the product set forth in the trial decision; (D) post the information set forth in the trial decision on the web site set forth in the trial decision; and (E) not ship the product when a compulsory license, if required in the Importing Country, was not granted. l The Commissioner may cancel the compulsory license upon request from the patentee or /ex officio /in case that: (1) the licensee fails to fulfill in good faith any of the obligations set out above (A) to (E); (2) the Importing Country notifies that the circumstances which led to the compulsory license cease to exist; and (3) any other circumstances which led to the compulsory license cease to exist. Coming into Effect of the Compulsory License: l The grant of a compulsory license becomes effective only after the Commissioner has recorded the contents of the trial decision on the Patent Register. l The licensee may from time to time request the Commissioner to make changes in the Patent Register as to the quantity, the packaging or labeling of the product when such a change occurs after the grant of the compulsory license. [End of the Document] From Seco.Gerard@msf.org Tue Nov 2 15:16:01 2004 From: Seco.Gerard@msf.org (Seco Gerard) Date: Tue Nov 2 15:16:01 2004 Subject: [Ip-health] EU proposal for August 30th solution implementation Message-ID: Access to essential medecines=0D =0D Access to medicines: Commission proposes to allow export of generic=0D medicines to poor countries=0D Brussels, 29 October 2004=0D =0D =0D =0D The European Commission has proposed a Regulation to allow manufacturers of= =0D generic pharmaceuticals to produce patented medicines for export to=0D =93countries in need=94 without sufficient capacity to produce them. The=0D Regulation would implement within the EU a WTO decision of 30th August 2003= =0D under which national authorities can grant =93compulsory licences=94 for su= ch=0D production if certain conditions are fulfilled. One requirement is that the= =0D destination country must have notified the WTO that it is seeking the=0D medicine covered by the licence. The proposed Regulation puts no further=0D restriction on the medicines and diseases to be covered. To help ensure tha= t=0D medicines get to the patients who need them and to protect patent holders,= =0D customs authorities will be able to prevent the re-importation into the EU= =0D of medicines produced under the system.=0D =0D Internal Market Commissioner Frits Bolkestein said: =93The WTO decision and= =0D our proposed Regulation can help save lives by helping countries in need to= =0D acquire affordable medicines, without undermining the patent system, which= =0D is one of the main incentives for the research and development of new=0D medicines.=94=0D =0D Trade Commissioner Pascal Lamy said: =93By adopting this proposal the EU le= ads=0D the way in ensuring access to affordable medicines for poor countries. It= =0D shows that we are delivering on our promises in the Doha Development Agenda= .=0D I now hope that it can be taken forward quickly by the EU Member States and= =0D the European Parliament.=94=0D =0D The proposed Regulation would set up a system for companies who wish to=0D manufacture medicines for export to apply to national authorities for the= =0D grant of a =93compulsory licence=94 from a patent holder who has exclusive= =0D rights over the manufacture and sale of the products concerned. Most=0D national laws at present do not allow compulsory licences for export becaus= e=0D until recently the WTO TRIPS Agreement provided for compulsory licences onl= y=0D =93predominantly for the supply of the domestic market=94. The Doha declara= tion=0D on trade and health adopted in November 2001 agreed to address the=0D difficulties raised by this restriction for developing countries with no=0D manufacturing capacity. After long negotiations, on 30 August 2003 WTO=0D members agreed on a waiver giving these countries access to much needed=0D generics.=0D =0D Provided countries in need notify to the WTO the medicines they need, it=0D would be up to generic companies to decide to apply for licences to=0D manufacture them.=0D =0D Once export takes place, all parties have an interest in seeing that=0D medicines are not diverted from those who need them. The Commission's=0D proposal would prohibit re-importation into the EU and provide for customs= =0D authorities to take action against goods being re-imported. The patent=0D holder could use existing national procedures to enforce its rights against= =0D re-imported goods if they do enter the EU, and the licence could be=0D terminated.=0D =0D While the EU does not require a medicinal marketing authorisation for=0D exported products, importing countries may want to ensure that medicines ar= e=0D safe and effective. In the proposal provision is made for use of the EU's= =0D scientific opinion procedure for evaluating medicines under Regulation (EC)= =0D no 726/2004.=0D =0D The rules also ensure that marketing authorisations do not lapse for reason= =0D of non-use in the EU, and set out exemptions from data protection rules=0D which usually require manufacturers of generic medicines to wait for eight= =0D years before they can obtain authorisations using data from previous=0D clinical trials conducted by others.=0D =0D =0D =0D =0D =0D =0D Back to top=0D -----------------------------------------------------------=0D Seco Gerard=0D MSF Access Campaign EU Liaison Officer=0D C/O MSF Belgium=0D Rue Dupr=E9 94=0D 1090 Brussels=0D Direct number: +32 2 474 75 09=0D Fax number: +32 2 474 75 75=0D Mobile number: +32 479 514 900=0D =0D From KateEvans@newyork.msf.org Tue Nov 2 15:16:08 2004 From: KateEvans@newyork.msf.org (Kate Evans) Date: Tue Nov 2 15:16:08 2004 Subject: [Ip-health] MSF Press Release - Lack of AIDS Drugs for Children Message-ID: This is a multipart message in MIME format. -- [ Picked text/plain from multipart/alternative ] Doctors Without Borders/M=E9decins Sans Fronti=E8res (MSF) For Immediate Release Lack of AIDS Drugs for Children: A Matter of Life and Death Geneva, November 2, 2004 ? Children with AIDS are dying needlessly because of a lack of suitable and adapted medicines, according to the international medical humanitarian organization Doctors Without Borders/M=E9decins Sans Fronti=E8res (MSF). A day before the opening of a pediatric AIDS summit organized by the World Health Organization (WHO) and UNICEF in Geneva, MSF highlights experience that shows treating children with HIV/AIDS is much more expensive and difficult than treating adults. Simplified ways to treat HIV/AIDS in adults have become available to patients in developing countries within the past year. Most adult patients in developing countries now take either a triple fixed-dose combination treatment ? one pill twice a day ? or one double combination plus a third drug. But neither the triple nor double combinations are available in dosages for children. When childhood doses are available, they come at a premium. It can cost over six times more to treat a child than to treat an adult ? US$1,300 versus US$200 per year (for a 14-kg patient taking three different syrups). ?Since companies do not make easy-to-use triple drug combinations for children, I do what most doctors are doing: I try to show caregivers such as grandparents how to crush and break adult tablets, hoping that the children will get the doses they need,? said Dr Koen Frederix, a pediatrician working for MSF in Malawi. ?Small children can?t swallow tablets so they have to use different syrups in different quantities, which complicates treatment.? There is only a weak global market in pediatric AIDS drug formulations: in wealthy countries relatively few children are being born with HIV, while developing countries are often simply too poor. Consequently, drug companies have little interest in developing or marketing pediatric formulations adapted to poor countries, such as fixed-dose combinations or breakable or chewable tablets. The only hope on the horizon is that some companies may choose to develop fixed-dose combinations or adapted formulations for children. Some ongoing studies are looking at once-daily tablets for children. However, without the lure of a lucrative market, companies are not allocating enough resources to make quick progress. MSF urges the WHO, UNICEF and national governments to document the extent of this crisis and to lead the charge to overcome the lack of a market for AIDS drugs for children. ?The WHO and UNICEF, the UN?s children?s agency, should sound the alarm,? said Daniel Berman, HIV/AIDS coordinator for MSF?s Campaign for Access to Essential Medicines. ?This week the experts will meet to identify the gaps. But to really make an impact, international organizations and national programs will need to work proactively with governments and drug companies to overcome the lack of commercial interest in AIDS drugs for children.? MSF began treating children with antiretrovirals (ARVs) in December 2000. By mid-2004, about 5% of MSF patients on ARV treatment were children under 13. MSF is committed to doing better for children, but the efforts of our doctors have been frustrated by the lack of proper tools. MSF teams have created innovative tools to support health care providers in prescribing ARVs and supporting adherence in children, such as health diaries, treatment calendars, and fairy tales about ?Devimmon?, a witch that is a metaphor for HIV, in an effort to help children understand and adhere to treatment. The estimated worldwide number of children with HIV/AIDS was over 2.5 million in 2003. In the same year, 700,000 children under the age of 15 were newly infected with HIV/AIDS, 88.6% of whom live in sub-Saharan Africa. Approximately 50% of children with HIV/AIDS die before the age of two. # # # For more information visit our website at: www.doctorswithoutborders.org _____________________________________________ Kris Torgeson Communications Director Doctors Without Borders/Medecins Sans Frontieres (MSF) 333 Seventh Avenue, 2nd Floor New York, NY 10001 Tel: 212-655-3764 Cell: 917-913-0183 Fax: 212-679-7016 _____________________________________________ From KateEvans@newyork.msf.org Tue Nov 2 15:16:15 2004 From: KateEvans@newyork.msf.org (Kate Evans) Date: Tue Nov 2 15:16:15 2004 Subject: [Ip-health] MSF Briefing Note on Children and AIDS Message-ID: This is a multipart message in MIME format. -- [ Picked text/plain from multipart/alternative ] Doctors Without Borders/M=E9decins Sans Fronti=E8res (MSF) Briefing Note Children and AIDS: Neglected Patients November 2, 2004 ?HIV treatment for adults is slowly becoming easier, with increasing availability in developing countries of a three-drug cocktail in one tablet. But children who need treatment still have to drink large amounts of foul tasting syrup or swallow large tablets ? that?s if they can actually access treatment at all. Children with HIV are generally not interesting for pharmaceutical companies, but some generic companies are developing more child-friendly ARV treatments. International agencies need to push this issue higher up the agenda and governments will need to remove barriers to the use of generic products.? -- Dr Koen Frederix, MSF pediatrician, Malawi. Children with HIV/AIDS are being neglected. Doctors treating them have very limited choices of drugs at their disposal, and so around 50 percent of children with HIV/AIDS die before the age of two. The estimated worldwide number of children with HIV/AIDS was over 2.5 million in 2003. In the same year, 700,000 children under the age of 15 were newly infected with HIV/AIDS. Although children represent only six percent of HIV infections, they account for 17 percent of deaths due to AIDS. In wealthy countries, relatively few children are being born with HIV, due in large part to the success of efforts to prevent mother-to-child transmission. Some pediatric formulations (such as syrups) do get developed and manufactured for this market. However, because of a lack of commercial interest, these formulations are not available for children in developing countries because they are either too expensive or simply not registered and/or marketed. Further, developing countries also need different formulations better adapted to their context, such as chewable and breakable tablets. At present these pediatric formulations are lacking. There are several major problems facing clinicians: First, there is the problem of diagnosis. Most serological methods used to diagnose HIV are not reliable for children under 18 months. Virological confirmation tests are needed but these tests are expensive, need sophisticated lab facilities and thus are not available. Monitoring CD4 (the white blood cell targeted by HIV) is also difficult, since most of the commercially available CD4 count machines are not adapted for use in young children. The second critical challenge is the lack of pediatric formulations of antiretrovirals (ARVs), which makes determining and administering doses complex and burdensome and often leads to over- or under-dosing. As children grow, doses must be adjusted but this is difficult in the absence of pediatric formulations. For children under 10 kilos, difficult-to-measure syrups are used, often in large quantities. Syrups and oral solutions are not suitable for use in older children because of the large volumes needed, but low dosage tablets and capsules are not produced for most ARVs. In practice, this means that caregivers are forced to measure syrups and cut and crush adult formulations. There are no pediatric fixed-dose combinations. This means that children do not have the possibility to take one pill twice a day, like adults do. Some studies are looking at once-daily tablets. Projects are underway at public drug producers such as the Government Pharmaceutical Organization in Thailand and the generic company Cipla in India. However, since there is no lucrative potential market, European and US-based companies (and even some generic companies) are, for the most part, not interested in developing pediatric formulations adapted to poor countries. This is why the leadership and involvement of governments and international organizations such as the World Health Organization (WHO) and UNICEF is so critical. A third major problem is the lack of simple guidelines and tools to facilitate prescription. Currently, doses are determined according to weight or body surface. In developing countries, there are no standardized dosing schedules, and doctors and other health professionals have no simple guidelines for treatment of HIV in children. Standardized dosing charts can help avoid miscalculation and can support prescribing of ARVs. The fourth major challenge is the high price of the pediatric formulations that do exist. Both first- and second-line ARV treatment for children costs several times more than for adults. While the fixed-dose version of d4T/3TC/NVP for adults is available for about US$200 per patient per year, the best price for the same drugs in pediatric formulations is approximately US$1,300 (oral solutions and syrups for a 14 kg children). Further examples of problems include: Merck does not offer any reduced, differential price for its efavirenz syrup, and there are no WHO pre-qualified generic versions of d4T oral solution. MSF began treating children with ARVs in early 2002. By the middle of 2004, only 5 percent of MSF patients were children under 13. MSF is seeking to increase the numbers of children under treatment, but our efforts are frustrated by the lack of proper tools. MSF is committed to fighting for the development of appropriate, practical and affordable diagnostics and drug formulations to facilitate widespread treatment of children with AIDS. _______________________________________________________ Kate Evans Program Associate, Campaign for Access to Essential Medicines Doctors Without Borders/Medecins Sans Frontieres (MSF) 333 7th Ave, 2nd Floor *New York, NY *10001-5004*USA Tel: +1-212-655-3773 Fax: +1-212-679-7016 E-mail: kate.evans@newyork.msf.org http://www.doctorswithoutborders.org http://www.accessmed-msf.org From gaulep@who.int Wed Nov 3 10:58:01 2004 From: gaulep@who.int (gaulep@who.int) Date: Wed Nov 3 10:58:01 2004 Subject: [Ip-health] WHO workshop on intellectual property rights and vaccines in deve loping countries Message-ID: This message is in MIME format. Since your mail reader does not understand this format, some or all of this message may not be legible. -- [ Picked text/plain from multipart/alternative ] > The importance of vaccines and immunization for public health is widely > recognized. However, the debate on intellectual property and access to > pharmaceuticals has developed with relatively few references to vaccines. > Questions such as: > - How does intellectual property affect access to vaccines in developing > countries ? > - What will be the impact of the 2005 deadline on developing country > vaccine manufacturers (an increasingly important part of global vaccine > supply) ? > - Does IP protection stimulate R&D for vaccines needed in developing > countries ? > - What IP issues do Public Private Partnerships developing vaccines > encounter ? > were discussed at a workshop on Intellectual Property Rights and Vaccines > in Developing Countries in Geneva organized by WHO's Immunization, > Vaccines and Biologicals Department on 19-20 April 2004 > The meeting was primarily an opportunity for the participants > (representing OECD and developing country manufacturers, public-private > partnerships in vaccine R&D, public sector research institutions, > international organizations and NGOs) to exchange views and share their > experiences on a potentially controversial but relatively unexplored > topic. > Presentations given during the meeting and the meeting report can now be > accessed at the following address: > http://www.who.int/intellectualproperty/events/vaccines_meeting/en/ > > For more information contact: > > Mr Miloud Kaddar > World Health Organization > Access to Technologies > Department of Immunization, Vaccines and Biologicals > Telephone: +41 22 791 1436 > Email: kaddarm@who.int > From jwkckid1@ix.netcom.com Thu Nov 4 10:19:01 2004 From: jwkckid1@ix.netcom.com (Jeff Williams) Date: Thu Nov 4 10:19:01 2004 Subject: [Ip-health] Pharmaceutical Shares Climb On Bush Apparent Win Message-ID: <4189C5E0.58D4E948@ix.netcom.com> All, Well now that the president has won re-election, seems that the drug companies have rallied... http://www.forbes.com/2004/11/03/cx_ab_1103video1.html Regards, -- Jeffrey A. Williams Spokesman for INEGroup LLA. - (Over 134k members/stakeholders strong!) "Be precise in the use of words and expect precision from others" - Pierre Abelard "If the probability be called P; the injury, L; and the burden, B; liability depends upon whether B is less than L multiplied by P: i.e., whether B is less than PL." United States v. Carroll Towing (159 F.2d 169 [2d Cir. 1947] =============================================================== Updated 1/26/04 CSO/DIR. Internet Network Eng. SR. Eng. Network data security IDNS. div. of Information Network Eng. INEG. INC. E-Mail jwkckid1@ix.netcom.com Registered Email addr with the USPS Contact Number: 214-244-4827 From mpalmedo@cptech.org Thu Nov 4 11:04:01 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Thu Nov 4 11:04:01 2004 Subject: [Ip-health] InPharma.com - EU could allow generics of patented drugs for countries in need Message-ID: <418A4CDF.9010400@cptech.org> http://www.inpharma.com/news/news-ng.asp?n=3D55859-eu-could-allow EU could allow generics of patented drugs for countries in need InPharma.com 04/11/2004 The European Union has put forward new legislation that would allow generic manufacturers to make drug products with in-patent active pharmaceutical ingredients, provided that they are intended for use in developing countries, reports Phil Taylor. The move would bring the EU into line with World Trade Organisation recommendations that allow patented drugs to be copied and exported to poorer countries in the world that do not have the infrastructure in place to produce the drugs themselves. Under this system, countries notify the WTO of the medicines they need, and generic manufacturers would be able to apply to meet the demand. This would involve contacting their national authorities for a 'compulsory license' from the holder of the drug=92s patent. The WTO agreed last summer to extend the system of compulsory licenses to foreign manufacturers in order to improve access to medicines in the third world. Prior to this, only domestic companies could seek this form of patent suspension. The system will make it possible for generic manufacturers to develop the processes required to make APIs and secure an immediate market for the products, ahead of the expiration of the originator=92s patents in Euro= pe. This could accelerate the introduction of generics once the intellectual property for a drug expires in Europe, but has also raised concerns that the products could be diverted from their intended recipients and re-imported for sale in the EU. The Commission has suggested measures to prevent medicines produced under the compulsory licensing scheme from re-entering the EU. Customs authorities would be authorised to take action against the re-importation of goods and the patent holder could use existing national procedures to reinforce its rights, and the license could be terminated if re-importation occurs. Meanwhile, the UK-based aid agency Oxfam has welcomed the move but says this legislative change will have to be monitored carefully to see how it works in practice. "The legal mechanism agreed by the World Trade Organization is complex and, even if a developing country fights through the red tape, its market may not be large enough to allow generic companies to offer lower prices, " said the group in a statement. Oxfam believes the proposal could be improved by doing away with time-consuming negotiations with the patent holder in the event of a public health emergency in a developing country. The longer-term solution is for generic production to be the norm, and not the exception, in developing countries, said Oxfam, although it conceded that this development would require major reform of the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPs) agreement. From mpalmedo@cptech.org Thu Nov 4 11:04:07 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Thu Nov 4 11:04:07 2004 Subject: [Ip-health] Open letter to trade and foreign ministers of EU-SACU FTA countries Message-ID: <418A4FCB.9060002@cptech.org> http://www.evb.ch/cm_data/Open_letter_EFTA.pdf Open letter to the trade and foreign ministers of EFTA's states. November 4, 2004 To: - B=F8rge Brende, Minister of Trade and Industry (Norway) - Joseph Deiss, Federal Councillor, Head of the Federal Department of Economic Affairs (Switzerland) - David Oddsson, Minister for Foreign Affairs (Iceland) - Ernst Walch, Minister for Foreign Affairs (F=FCrstentum Liechtenstein) CC: - relevant ministers in South Africa, Lesotho, Namibia, Botswana, Swaziland Dear ministers, The EFTA states are currently negotiating a bilateral free trade agreement with the states of the Southern African Customs Union (SACU), Botswana, Lesotho, Namibia, South Africa and Swaziland. According to declarations by the relevant Swiss ministry, the EFTA states intend to include in that agreement provisions on intellectual property that are going beyond the WTO TRIPs agreement (thereafter "TRIPs-plus" provisions). The undersigned organizations want to express their strong opposition to such inclusion. We are of the same opinion as the British Commission on Intellectual Property Rights that =84developed countries should review their policies in regional/bilateral commercial diplomacy with developing countries so as to ensure that they do not impose on developing countries standards or timetables beyond TRIPS.=94[1] The British government endorsed that CIPR's recommendation. We are in particular strongly opposed to TRIPs-plus provisions for agriculture and medicines. If adopted, those provisions would have lasting negative consequences on the public health and on the food security in SACU countries. Our concerns are based on the presence of such provisions in the free trade agreements that were concluded earlier with other developing countries (e.g. EFTA's free trade agreements with Chile from 26 June, 2003, and with Lebanon from 24 June, 2004). EFTA's TRIPS-plus provisions on medicines We fear that EFTA states are pressuring SACU states to introduce in their legislation a five to ten years exclusivity on data for registration of brand-name medicines. Such a protection would apply even when a medicine is not patented or is subject to a compulsory licence. During the period of protection, regulatory authorities will not be able to automatically rely on data of clinical tests of original producers when approving the marketing of generic medicines. The authorization of the original producers will always be necessary, even in emergency situations. We are also concerned that EFTA countries are urging SACU states to grant 5-year patent extensions in order to compensate "unreasonable" delays in the procedure of market approval. Such a provision is subject to many interpretations and will delay introduction of generic medicines up to five years after the normal expiration of a patent. Those provisions are beyond the TRIPs obligations. They strengthen the monopolistic rights of pharmaceutical corporations at the expense of the patients. Their effect is to block and delay generic competition. However, the case of HIV/AIDS medicines has proved that generic competition is the most efficient tool to lower the price of medicines and therefore to improve access to medicines. This is particularly important in developing countries where the majority of the population lives in poverty and has to pay its medicines out of its own pocket. Such provisions are totally inappropriate for the SACU countries that have the highest HIV/AIDS prevalence rate among their adult population in the world : 21,1% in South Africa, 21,3% in Namibia, 28,9% in Lesotho, 37,3% in Botswana, 38,8% in Swaziland. In order to treat their population, those countries need to preserve their ability to use generic competition in order to obtain essential and life-saving medicines at affordable prices. They don't need to strengthen the monopolistic rights of giant pharmaceutical corporations. By seeking TRIPS-plus provisions, the EFTA states are denying the letter and the spirit of the Doha Declaration on the TRIPS agreement and public health they adopted in November 2001[2]. It states that every country has the "right to protect public health and, in particular, to promote access to medicines for all." EFTA's TRIPS-plus provisions in agriculture We would strongly disagree if EFTA states are asking SACU states to become members to the UPOV convention. Such requirement restricts the flexibility provided by the TRIPs agreement that allows countries to develop their own =93effective sui generis system=94 for protecting plant varieties. The African countries made a first step towards developing their own system by drafting an African Model law. Moreover, today countries can only become a contracting party to the 1991 version of UPOV, which is much stricter than the 1978 version, the one still applicable to older signatories, like Switzerland or Norway. Under UPOV 1991 farmers are no longer allowed to exchange seeds. If there is a drought for example and one farmer's harvest is destroyed, his neighbour may not give him any seed if this seed is protected under the plant protection scheme without the permission of the holder of the variety. In addition, under UPOV 1991 the use of farm-saved seeds is prohibited or at least severely restricted. For the moment South Africa is the only SACU state that is UPOV Member (UPOV 1978). We are concerned that EFTA states are asking SACU states to grant patents on =93biotechnological inventions=94. This provision goes beyond th= e TRIPS obligations. Because =93biotechnological inventions=94 can be plants or animals, this reference provides an opening for patents on certain plants and animals (without spelling this out clearly). This in a clear contradiction to the joint communication from the African Group at the TRIPS Council stating: =93Patents on life forms are unethical and the TRIPS Agreement should prohibit them.=94[3] Asking SACU states to become members to the 1997 Budapest Treaty would be another way to facilitate the patenting of life forms and is also =93TRIPS-plus=94. Those provisions are problematic in SACU states because the enforcement of intellectual property rights in agriculture restricts the farmers=92 rights, especially the right to use farmsaved seeds. Up to now informal supply systems, where farm-saved seeds are estimated to represent about 90% of planted seeds, are dominant in SACU states. Stronger IPRs would destroy those systems and the agricultural biodiversity. No intellectual property provisions in the EFTA-SACU free trade agreement Developing countries like the SACU states face huge challenges to achieve food security and optimal health care for their population. Therefore they need to keep sufficient freedom to adjust their intellectual property system to their needs. Intellectual property provisions in bilateral free trade agreements, however, reduce such freedom and have direct consequences on the right to food and the right to health of their people. In April 2001, under pressure of world public opinion, 39 pharmaceutical corporations had to withdraw their 1998 complaint against the South African government. Their reluctance to withdraw earlier did lasting damage to their reputation. By seeking, through TRIPs-plus provisions in the free trade agreement with SACU states, advantages for your industries irrespective of the public health and food needs of your trading partners, you are also putting the image and reputation of Switzerland, Norway, Iceland and Liechtenstein at stakes. As signatories of this letter, we require that there be no intellectual property provisions in the free trade agreement between the EFTA states and the SACU states. Sincerely, Signatories: South Africa: Njogu Morgan , Treatment Action Campaign (TAC), Elfrieda Pschorn-Strauss , Biowatch Norway: Svanhild-Isabelle Batta Bj=F8rnstad, Genesis Arvid Solheim, the Development Fund Liechtenstein: Regula Mosberger, Liechtenstein Association for Environmental Protection (LGU) Gerda Bicker, Welt und Heimat Robert Allg=E4uer, Aktion: Wir teilen. Das alternative Fastenopfer Switzerland: Fran=E7ois Meienberg & Julien Reinhard, Berne Declaration Christian Captier, MSF-Switzerland Namibia: Delme Cupido, Aids Law Unit Emma Tuahepa, Lironga Eparu International NGOs: C=E9line Charveriat, Oxfam International Ren=E9e Vellv=E9, GRAIN Collette Campher, AIDS and Rights Alliance for Southern Africa (ARASA) Additional supporting organizations: South Africa: Southern African Catholic Bishops' Conference, Environmental Monitoring Group, SEATINI South Africa Chapter Namibia: Namibia Network of Aids Service Organisations (NANASO) Norway: Forum for utvikling og milj=F8/ Forum for Development and Environment; Naturvernforbundet/ Friends of the Earth =96 Norway; Natur og Ungdom/ Friends of the Earth Youth =96 Norway; Changemaker; Kirkens N=F8dhjelp/ Norwegian Church Aid; Norges Bondelag/ Norwegian Farmers=92 Union; Attac Norway Switzerland: Swiss Aids Federation, Swiss Coalition of Development Organizations, Greenpeace Switzerland, Swiss Interchurch Aid, Bread For All, Fondation Terre des Hommes, F=E9d=E9ration Genevoise de Coop=E9ration, F=E9d=E9ration Romande des Consommateurs, Comedia, Swissaid, Medicus Mundi Switzerland, SolidarMed, Antenne Sida du Valais romand, Association Romande des Magasins du Monde (ASRO), Attac Suisse, Basler Appell gegen Gentechnologie, Bethlehem Mission Immensee, Blauen-Institut, Coalition "A Gauche toute!", Co-operaid, DM-=E9change et mission, Enseignants Sans Fronti=E8res, Groupe sida Gen=E8ve, HorYzon - la dimension internationale des Unions Chr=E9tiennes Suisses, Parti Les communistes, Parti socialiste genevois, PLANeS, Restaure la Terre, SID'Action, Solidarit=E9S, Syndicat des services publics - section Gen=E8ve, Vivere France: Act Up-Paris November 4, 2004 -------------------------------------- FOOTNOTES: 1 Commission on Intellectual Property Rights. Integrating Intellectual Property Rights and Development Policy. 2002. 2 Declaration on the TRIPS agreement and public health adopted on 14 November 2001 (WT/MIN(01)/DEC/2) 3 Taking forward the review of article 27.3 b of the TRIPs Agreement, 26 June 2003 (IP/C/W/404) From access@msf.org.br Thu Nov 4 17:18:00 2004 From: access@msf.org.br (access@msf.org.br) Date: Thu Nov 4 17:18:00 2004 Subject: [Ip-health] Exclusive Marketing Rights in Brazil for Taxotere - Aventis Message-ID: <006201c4c29f$2ca9ca50$1c01a8c0@MichelL> This is a multi-part message in MIME format. -- [ Picked text/plain from multipart/alternative ] Hello there I am Michel Lotrowska, access campaign liaison in Brazil and I have a question on EMRs in Brazil. Aventis has requested a patent on taxotere in Brazil on 7th june 1995, (PI 9508789-3) which is in the mailbox period of Brazil. Until now the result of the patent hasn't been given but it is known that INPI would grant the patent while the "prior consent" of the ANVISA would probably not grant the patent (the Prior consent being an analysis of the patent made by the DRA since 2001 in Brazil for human medicine in complement to the INPI). The final decision of the patent analysis has not been publicized yet and in the meantime 4 competitors entered the market (one of them being Novartis) with other docetaxel similar products, driving (slowly) prices down for government purchases which are done through public tenders ...Novartis won a few contracts with cheaper prices. Up to now, Brazil has not notified WTO on how he would use the EMRs and there is no reference in Brazilian law (that I know of) on EMRs. On 15th of june 2004, the president of INPI (that has been replaced since then) signed a certificate granted EMRs to Aventis based on the paragraph 9 of the article 70 (referring to the point 8-a of the article) of the TRIPS agreement and all competitors had to stop selling the product. Some lawyers in Brazil seem to say that the decree that incorporated the TRIPS into Brazilian legislation (Decree 1355 of 30 december 1994) is enough to justify the concession of the EMRs while others seem to say that if there is no specification of how the EMRs will be implemented, TRIPS is not enough justify the use of EMRs. Any idea on what should be don in this specific case ? Best regards Michel Lotrowska Access Campaign Liaison for MSF in Brazil Tel Office:+5521-2220-3523 Mobile: +5521-8111-3-666 Rua Santa Luzia 651-11 Cep:20030-040 Rio de Janeiro - Brasil -- From mpalmedo@cptech.org Fri Nov 5 15:12:01 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Fri Nov 5 15:12:01 2004 Subject: [Ip-health] ip-watch: Public Health Groups, Members of Congress claim CAFTA will choke Access to Medicines Message-ID: <418BA94D.10105@cptech.org> http://www.ip-watch.org/weblog/index.php?p=3D8&res=3D1024_ff&print=3D0 The Domino Effect of US FTAs: Public Health Groups, Members of Congress claim CAFTA will choke Access to Medicines IP-Watch Isabelle Scherer 11/4/2004 Recent efforts to rally Congress to approve a Free Trade Agreement (FTA) reached earlier this year with Central American countries has reignited debate about USTR=92s approach to intellectual property and the implications for access to essential medicines. The Agreement with Costa Rica, El Salvador, Guatemala, Honduras and Nicaragua was reached in May 2004 and supplemented in August by the addition of the Dominican Republic. With election results uncertain, USTR worked throughout October to lobby Congress to approve CAFTA as swiftly as possible. While trade advocates are pushing for the pact to go for a vote in Congress before the end of the year, some Members of Congress are making the case for caution. On September 30, twelve Members of Congress wrote to President Bush to =93express [their] strong opposition to the inclusion of provisions in pending free trade agreements,=94 such as the CAFTA, =93that would restrict access to generic drugs.=94 While USTR boasts that its recently concluded bilateral agreements provide for =93higher levels of IP protection in a number of areas covered by the TRIPS Agreement,=94 the September 30 letter expressed strong concern that provisions in these agreements violate in the terms of the 2002 Trade Promotion Authority Act which instruct USTR to uphold the 2001 WTO Declaration on the TRIPS Agreement and Public Health. The main text of the CAFTA fails to make any reference to the rights of WTO Members to protect public health. Noting the addition of an =93Understanding Regarding Certain Public Health Measures=94 to accompany CAFTA, public health groups criticise USTR for refusing to explicitly include either exceptions to protect health or references to the Doha Declaration in the text of agreements. According to the Centre for Policy Analysis on Trade and Health, the side letter approach falls short of promoting access to medicines for all as set forth in the Doha Declaration and given its legally ambiguous status fails adequately =93to offset=94 CAFTA=92s intellectual property provisions. For the U.S. pharmaceutical industry, however, all of this is good news. Earlier this year, for example, the Pharmaceutical Research and Manufacturers of America (PhRMA) recommended that Central American countries =93remain on the 2004 =91Special 301? list due to persistent problems with intellectual property enforcement=94 and set out a series of grievances against each of the countries. In expressing its satisfaction with the CAFTA, PhRMA has surprised many public health advocates by arguing that the agreement will =93improve patient=92s access to medicines.= =94 Public health advocates disagree. Arguing that CAFTA will =93cost lives=94, Rob Weissman of Essential Action describes it as a deal that =93uniformly favors the interests of multinational drug companies over those of patients.=94 M=E9decins Sans Fronti=E8res argues that CAFTA-style provision= s =93could put an end to competition from generic medicine producers and to the ability of countries to prevent the abuse of patents.=94 CAFTA appears to represent the apex of TRIPS-plus provisions in recent U.S. FTAs. In a recent comparison of five such agreements, Oxfam International notes that while the terms vary, recent U.S. FTAs effectively increase patent protection beyond the twenty years required by TRIPS, place TRIPS-plus conditions on the granting of compulsory licenses, provide for the extension of patents to =91compensate=92 for delays in the marketing approval process, mandate or increase requirements for test data protection of several years, and establish a link between IP protection and regulatory approval processes (such that a generic company may have to wait until a patent has fully expired before it can apply for regulatory approval). Several civil society groups have noted the irony of USTR=92s push for =91TRIPS-plus=92 standards at the same time as Congress is debating options for improving the affordability of medicines within U.S. borders. While several U.S. states are approving legislation to enable U.S. citizens to buy medicines more cheaply from Canada, USTR is pushing for agreements that prevent citizens in developing countries from doing the same. ****************** SIDEBAR: U.S. Bilateral and Regional Free Trade Agreements Since TRIPS was adopted in 1994, the United States has forged ahead with bilateral agreements with, among others, Jordan (2000), Chile (2003), Singapore (2003), Morocco (2004) and Australia (2004). Negotiations are under way with the countries of the Free Trade Area of the Americas (FTAA), Thailand, Panama, Bahrain, members of the South African Customs Union (SACU) and the Andean region. From mpalmedo@cptech.org Fri Nov 5 15:12:08 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Fri Nov 5 15:12:08 2004 Subject: [Ip-health] Link to proposed EC regulation on compulsory licensing for export Message-ID: <418BB2F4.9020404@cptech.org> The link in the EC press release does not work, but the text of the proposed regulation can be found here: http://trade-info.cec.eu.int/doclib/docs/2004/october/tradoc_119802.pdf Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems From mpalmedo@cptech.org Fri Nov 5 18:38:00 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Fri Nov 5 18:38:00 2004 Subject: [Ip-health] Reuters: Bush win seen leading to more US trade pacts Message-ID: <418C092E.3000103@cptech.org> http://www.nzherald.co.nz/business/businessstorydisplay.cfm?storyID=3607015&thesection=business&thesubsection=trade&thesecondsubsection=general&thetickercode= Bush win seen leading to more US trade pacts Reuters 04.11.2004 President George W Bush is expected to pursue an aggressive agenda of new trade agreements during his second term, even if he reshuffles his trade team, US industry officials said. Bush's re-election will allow the United States to push forward on world trade talks and a long list of other trade deals without significant delay, the officials said. His Democratic challenger, Sen John Kerry of Massachusetts, had promised a 120-day review of all trade agreements if elected and said he would insist on tougher labour and environmental provisions in new trade pacts. He also pledged to renegotiate an agreement with five Central American countries that Bush concluded last year and is strongly opposed by US labour, textile and sugar groups. Kerry's cautious stance raised questions about whether he would continue free trade talks with Thailand, Panama, Colombia, Peru, Ecuador and South Africa begun by Bush. Instead of worrying about that, manufacturing and other business groups are preparing lists of additional countries they think would make good free trade partners. They could include Egypt, South Korea, NEW ZEALAND, Pakistan, the Philippines, Sri Lanka and Taiwan, business sources said. Bush faces a tough challenge to win congressional approval of the US-Central American Free Trade Agreement, or CAFTA, despite a slight increase in the number of Republicans in the House of Representatives and the Senate. "CAFTA will still be in the cross hairs. I think that all the trade angst that Democrats have on labour will be focused on that," said Frank Vargo, vice president for international affairs at the National Association of Manufacturers. Many business leaders believe Bush's chief negotiator, US Trade Representative Robert Zoellick, is anxious to move on after four years in the job. Zoellick, who has a long career in financial and foreign policy affairs, has been mentioned for several high-profile jobs that could become available, including secretary of state, treasury secretary or president of the World Bank. If Zoellick leaves, Bush could promote Deputy US Trade Representative Peter Allgeier or Deputy US Trade Representative Josette Shiner to the job. Other potential candidates include Commerce Undersecretary Grant Aldonas or former deputy national security adviser Gary Edson, business sources said. From mpalmedo@cptech.org Fri Nov 5 18:38:07 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Fri Nov 5 18:38:07 2004 Subject: [Ip-health] IPS on EU's proposed regulations for export of compulsorily licenced drugs Message-ID: <418C0AC7.10605@cptech.org> http://ipsnews.net/interna.asp?idnews=3D26090 Cheaper Medicines for AIDS Welcomed Stefania Bianchi BRUSSELS, Nov 1 (IPS) - A leading development group has welcomed EU proposals to allow export of cheap medicines to poor countries fighting HIV/AIDS and other killer diseases. The European Commission, the European Union (EU) executive, proposed a regulation Friday (Oct. 29) to allow generic pharmaceutical manufacturers to produce patented medicines for export to =94countries in need.=94 Under a system to be known as 'compulsory licensing', poor countries facing public health crises will be able to override patents on expensive drugs and order cheaper copies from generic manufacturers in other countries. The country seeking the cheap medicine would have to notify the World Trade Organisation (WTO) that it is applying for the medicine covered by the licence. Patent holders would receive a small payment for the service. Under the current system, governments can only issue compulsory licenses for use within their own countries and are banned from exporting to the majority of countries that have no domestic pharmaceuticals industry for the needed medicines. The EU says the new system will help =94ensure that medicines get to the patients who need them and to protect patent holders.=94 The commission adds that the proposals will prohibit re-importation of medicines produced under the system into the EU and will allow patent holders to use existing national laws to enforce their rights if the drugs were smuggled back in. The proposals implement a decision made at the WTO last August to lift restrictions on the export of generic medicines. Outgoing EU trade commissioner Pascal Lamy said Friday that the proposals demonstrated the EU's commitment to the Doha Development trade round. =94By adopting this proposal the EU leads the way in ensuring access to affordable medicines for poor countries,=94 he told media representatives. =94It shows that we are delivering on our promises in the Doha Development Agenda.=94 Internal market commissioner Frits Bolkestein said the proposals would help save lives in developing countries. =94The WTO decision and our proposed regulation can help save lives by helping countries in need to acquire affordable medicines, without undermining the patent system, which is one of the main incentives for the research and development of new medicines,=94 he added. The development group Oxfam said the EU was sending =94a positive political signal=94 to developing countries. =94With 14 million people dyin= g every year from infectious diseases, it is essential that developing countries feel confident about supplying cheaper generic medicines to their citizens in the face of hostility from the giant drug companies and the United States government,=94 Michael Bailey, senior policy advisor at Oxfam said in a statement. But the group urged the EU to ensure the regulation does not lead to =94too much red tape=94 that could slow poor nations' efforts to get cheap drugs in a health emergency. =94The legal mechanism agreed by the WTO is complex, and even if a developing country fights through the red tape, its market may not be large enough to allow generic companies to offer lower prices,=94 said Bail= ey. =94The European Commission and the World Health Organisation will need to monitor carefully how this legislative change works in practice, across the full range of diseases affecting developing countries,=94 he added. Oxfam is urging the EU to extend its proposals. =94The longer term solution is for generic production to be the norm in developing countries, not the exception,=94 said Bailey. The regulation will need to be approved by the bloc's 25 national governments and the European Parliament. It is expected to be submitted for approval early next year. (END/2004) From james.love@cptech.org Sun Nov 7 09:46:01 2004 From: james.love@cptech.org (James Love) Date: Sun Nov 7 09:46:01 2004 Subject: [Ip-health] Scrip on IFPMA lobbying efforts Message-ID: <418E338E.2060308@cptech.org> Scrip, 11/4/2004 - he pharmaceutical industry's global voice, the IFPMA, is bringing in a number of reforms to make it a better lobbying body. This comes at a time when the industry's image is taking a battering from numerous critics, including NGOs. They charge that the industry overprices medicines, launches few innovative treatments, inappropriately influences doctors' prescribing, and neglects research into diseases affecting the developing world. More negative publicity is expected for the industry when the filmmaker, Michael Moore, completes a new documentary in 2005, "Sicko", which among other things looks at the pharmaceutical sector. "One of the aims of the IFPMA will be better communications," Dr Harvey Bale, IFPMA director general, told industry delegates at the federation's biennial assembly meeting in Barcelona last week. It will be hiring a communications director, and consolidating its committees so that it will have five focusing on healthcare issues, regulatory policy and technical standards, and biologicals and vaccines. ...companies allowed The IFPMA, which has until now been a federation of pharmaceutical associations, will from now on allow pharmaceutical companies to be direct members. Already 19 multinationals from the US, Japan and Europe (including Pfizer, Sanofi-Aventis, Wyeth, Lilly, Bayer, Merck & Co and GlaxoSmithKline) have joined the federation, and six firms are considering doing so (including Serono, Fujisawa, Akzo Nobel and AstraZeneca). These new members are expected to give the federation more access to knowledge and expertise, closer collaborations with top-level management, and additional financial resources. Although Dr Bale would not provide financial details, the new members will double the federation's income. Currently, it runs on "several million Swiss francs", he told Scrip. The idea was conceived in the past few weeks and was the brainchild of the outgoing IFPMA president, Raymond Gilmartin, chairman, president and CEO of Merck & Co, and the incoming president, Dr Daniel Vasella, chairman and CEO of Novartis. ...new name The IFPMA will now be called the "International Federation of Pharmaceutical Manufacturers and Associations". (The logo will remain the same, the difference being the addition of the word "and". A similar step was taken some years ago by the European industry federation, EFPIA). The federation will also relocate from southwest Geneva to the northeast part to be closer to international bodies such as the World Health Organisation, the World Intellectual Property Organisation, the World Trade Organisation, UNAIDS and the World Bank. Dr Bale said the relocation, which will take place around June 2005, was more a "psychological" than a physical move. All of these moves are expected to help the IFPMA be a better lobbying group. Dr Bale says: "It really is advocacy [work], which includes partnerships, corroboration, lobbying, information and communication." He says the industry has only now begun to communicate at the global level with key bodies like the WHO, the WTO, the World Bank, the UN and WIPO. "This began to happen under Mr Gilmartin, with the building of a sense of confidence in the IFPMA structure, and now it is amending its ability to interact." ... Gilmartin's legacy Mr Gilmartin, whose company recently withdrew Vioxx (rofecoxib), was scheduled to open and close the IFPMA meeting, but he was unable to attend. However, Mr Gilmartin's work over the 2002-04 period was not forgotten. His presidency focused on partnerships to develop new medicines and on access to AIDS medicines, noted Dr Bale. "A highlight was resolving the blockage on the WTO compulsory licensing issue." On August 30th, 2003, the WTO agreed a waiver for the TRIPS agreement, which allows richer countries to export medicines under compulsory licences to developing countries who do not have manufacturing capacity. Dr Vassella's presidency is expected to build on the work of Mr Gilmartin but to focus on innovation. ...new rules The meeting was also the first held under Chatham House rules, because the lay press was invited. "Some of the media are new [to the assembly], and I was worried about quotes out of context," explained Dr Bale, adding that it could discourage open debate. However, the federation had little to fear as most sessions on access to medicines and the role of NGOs were uncontroversial and unchallenging. NGO speakers tended to be industry-friendly and spoke about the importance of partnership. Professor Richard Feachem, executive director of The Global Fund to Fight AIDS, TB and Malaria, praised the work of the industry, saying it had climbed out of the low point that was the 2001 court case in South Africa. "You are not part of the problem - you are part of the solution," he told industry. He also called on it to use its influence on legislators around the world, particularly in wealthy countries, to help grow the Global Fund. Dr Bale said the industry wanted dialogue with NGOs, but not with thosethat had already made up their minds. "We seek dialogue with NGOs who are prepared to exchange views and come to a better understanding of our industry. Some NGOs like CP Tech [run by James Love] have business plans which are unalterably anti-intellectual property." One speaker from a think-tank, the American Enterprise Institute, told the meeting that the global pharmaceutical industry's credibility and image was under attack. He said the proposed "Sicko" film would have devastating effects on the image of the industry. He said the "enemy must be engaged". "Recognise your enemies and neutralise them and act before they do." He said it was necessary that companies make the public battle a top priority. From mpalmedo@cptech.org Mon Nov 8 12:25:03 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Mon Nov 8 12:25:03 2004 Subject: [Ip-health] Health GAP letter to Indian PM on TRIPS Dealdline Message-ID: <418FA743.9010809@cptech.org> From the HealthGAP list... ----------------------------------------------------- November 8, 2004 The Honorable Dr. Manmohan Singh Prime Minister of India South Block, Raisina Hill New Delhi, India 110 011 Sent by Facsimile: +91.11.23019545 Dear Mr. Prime Minister, I am writing on behalf of Health GAP (Global Access Project), a U.S. advocacy organization fighting for access to affordable HIV treatment in developing countries. India, a major source of the world's generic medicines supply, is in the process of becoming compliant with the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). TRIPS requires that, by January 1, 2005, India protect and enforce product patents on pharmaceuticals. Widespread generic production in India has been possible because India currently only recognizes patents on pharmaceutical processes. The dramatic change to India's patent regime that will take place by January 1, 2005 will effectively eliminate a major source of supply of generic versions of new medicines for importing countries, while also jeopardizing access for Indians in need of affordable treatment. Health GAP is gravely concerned that the draft amendments to the Patents Act currently under consideration by the Group of Ministers will not remedy this situation. In fact, the amendments proposed would worsen the future of medicines access for people in need--in India and around the world. India is a signatory to the Doha Declaration on the TRIPS Agreement and Public Health (the "Doha Declaration"), which reaffirmed the right of all WTO Members to implement the TRIPS Agreement "in a manner supportive of WHO Members' right to protect public health and, in particular, to promote access to medicines for all." [1] India has made repeated public commitments to cooperate and collaborate with other developing countries and use the flexibilities afforded by the TRIPS Agreement to increase access to more affordable generic medicines. We strongly urge you to uphold your commitment, and to make full use of your rights under the TRIPS Agreement, as reaffirmed by the Doha Declaration, in order to prioritize public health and access to medicines for all over excessive monopoly rights for pharmaceutical companies. Therefore, we call on you to take the following steps as you consider amendments to the Patents Act: * Retain the pre-grant opposition procedure. This procedure permits opposition to patent applications the public feels are frivolous, protecting consumers against high prices on non-innovative pharmaceutical products under consideration for patent protection. The pre-grant opposition procedure aids in protecting India from wasting limited resources conferring monopoly rights on products that do not warrant patent protection. * Simplify and streamline India=B9s compulsory licensing procedure. Routine issuance of compulsory licenses after January 1, 2005 in India is critical if the rapid entry of generic versions of important pharmaceuticals is to continue. However, compulsory licensing in India is unnecessarily cumbersome and time consuming. The Indian regime for compulsory licensing must be reformed to facilitate routine and expedited compulsory licensing of important medicines. A strictly enforced deadline of one to three months should be established for the grant of a compulsory license, and rights of appeal should not include permission for injunctive relief that would impede the use of the license. * Remove draft provisions for new-use or second-use patents, currently described in Section 3(d) of the Patents Act. TRIPS does not require the granting of additional patents for new uses or new dosage forms for known medicines. New use or second use patents do not reward or encourage true innovation; they will however increase the cost of important medicines, compromise patient access, and extend monopolies over a longer period of time. Many of the pharmaceutical patent applications filed in India's patent "mailbox" are patent requests for second- or new-uses. * Fully implement the decision of the WTO General Council on the implementation of paragraph 6 of the Doha Declaration for countries that lack sufficient domestic pharmaceutical manufacturing capacity (the "August 30th Decision"). The draft amendment to the Patents Act would not permit export of compulsorily licensed medicines from India without a compulsory license granted in the importing country. Countries that need to import a low-cost generic medicine produced by compulsory license in India, but do not have a patent for the compulsorily licensed medicine in force, would not be allowed to import compulsorily licensed medicines exported by India, even though the August 30th Decision clearly permits this. Finally, we call on you to support a transparent process for the consideration of amendments to the Patents Act. We are extremely troubled by rumors that the Patents Act will be amended by Ordinance, which will eliminate the opportunity for the public to comment on and influence the amendment process. I look forward to your response to this urgent request. Sincerely, Asia Russell Director, International Policy Health GAP (Global Access Project) cc: The Honorable Minister Ram Vilas Paswan, Ministry of Chemicals and Fertilizers The Honorable Minister Kamal Nath, Ministry of Commerce and Industry The Honorable Union Minister Dr. Anbumani Ramadoss, Ministry of Health and Family Welfare The Honorable Ronen Sen, Ambassador of India to the United States of Americ= a Dr. Peter Piot, Director, UNAIDS Dr. Jong-Wok Lee, Director General, World Health Organization ------------------------------ FOOTNOTE: [1] "Declaration on the TRIPS agreement and public health,=B2 WT/MIN(01)/DEC/2, 20 November 2001 From jordankaysmith@yahoo.com Mon Nov 8 16:35:03 2004 From: jordankaysmith@yahoo.com (Jordan) Date: Mon Nov 8 16:35:03 2004 Subject: [Ip-health] Ranbaxy Recalls AIDS Drugs Message-ID: <20041108211857.38150.qmail@web52207.mail.yahoo.com> -- [ Picked text/plain from multipart/alternative ] This is a disturbing development out of South Africa. My hope is that all = patients currently being treated with these medicines will have access to o= ther treatment regimenes. Jordan Ranbaxy recalls AIDS drugs from South Africa The Times of India TUESDAY, NOVEMBER 02, 2004 MUMBAI: Ranbaxy SA, the South African arm of the Indian pharma major, has v= oluntarily recalled its entire portfolio of AIDS drugs marketed in South Af= rica, citing problems with the research company which conducted studies to = determine whether the drugs offered the same therapeutic benefits as the or= iginals. Confirming the development to TNN, a senior official at Delhi-based Ranbaxy= said the firm was in discussions with SA's drug regulator, the Medicines C= ontrol Council, which is a local regulatory authority on the lines of a Foo= d and Drug Administration body. Refusing to evaluate the recalled drugs, the official said they had written= to healthcare authorities asking them to return all batches of Lamaid, Nev= ran, Zidaid and Avocomb tablets to their wholesaler, or directly to Adcock = Ingram, Ranbaxy's JV partner in SA. Explaining that a report to the WHO in September had highlighted problems w= ith the bioequivalence studies for Avocomb tablets, the official said, "We = initiated fresh studies at a different centre. Subsequent investigations id= entified similar problems with the other products. --------------------------------- Do you Yahoo!? Check out the new Yahoo! Front Page. www.yahoo.com From james.love@cptech.org Tue Nov 9 08:07:04 2004 From: james.love@cptech.org (James Love) Date: Tue Nov 9 08:07:04 2004 Subject: [Ip-health] European Union Chamber of Commerce in Korea, Pharmaceutical Trade Issuses and Recommendations for 2004 Message-ID: <4190C0B9.7010701@cptech.org> This is a detailed and very interesting report published by the European Chamber of Commerce in Korea, concerning trade disputes with Korea over pricing of medicines. I have pulled out a few illustrative sections of the report, followed by the entire report. Jamie European Union Chamber of Commerce in Korea, Trade Issues and Recommendations for 2004 ** Our long running focus relates to Patient Access, Pricing and Reimbursement, because in this domain the authorities have targeted innovative, largely foreign products through cost containment measures, whilst retaining an unusually high generic, largely local , pricing policy. ** MOHW's has decided to set up from January 2004 under HIRA responsibility, a DUR committee for the purpose to promote an appropriate drug usage by carrying out development and implementation of guidelines for drug use evaluation. . . Although we do not oppose the principle of DUR committee, we would like to emphasize that the drug utilization review should be made purely on a scientific basis, and not on cost. ** A7 Pricing Situation. The Korean authorities originally accepted to define prices of innovative medicines as the average of the prices in 7 countries (France, Germany, Italy, Japan, Switzerland, UK and US) as set forth in the MOHW Notification No 2001-17, revised on April 18,2001. However, as "innovative" has never been precisely defined and needs to be agreed for each product, this qualification remains up to the arbitrary decision of those bodies charged with the responsibility of defining whether a product attains the classification of "innovative", and in fact, it is a way not to apply A7 pricing in most of the cases. Indeed there are only few products that have received A7 pricing according to the interpretation of industry. ** Improving cost efficiency ratio of healthcare policy is a legitimate goal. One should keep in mind, however, that improving this ratio but not reducing cost of healthcare is the legitimate goal. Rationalization of healthcare delivery but not it cost reduction are the usual effect of pharmacoeconomics. Accordingly, pharmacoeconomics cannot and should not be used as an alibi for drugs prices limitation or reduction. ** There also seems to be a continued misunderstanding by the KFDA of its obligations under TRIPs Article 39.3 with regard to the use of clinical data from published journal articles. Generic products have been able to gain registration during the re-examination period even though the data in the studies cited were the property of the originator. KFDA claim that the TRIPs protection prevents use of publicly disclosed data only for "commercial purposes". Foreign companies in Korea, however, assert that registration is clearly intended for a commercial purpose. Recommendation. The Korean Government should implement a prospective system for the administration of patent protection in pharmaceuticals, including directly linking the relevant product registration review (KFDA) and patent (KIPO) agencies for appropriate enforcement of patent protection. KFDA should also recognize that the purpose of securing a registration is clearly commercial. WHOLE REPORT BELOW...... http://www.eucck.org/trade/2004/question/el/pharmacy.htm PHARMACEUTICALS COMMITTEE 1 . Overview. The Korean authorities felt that comments in the 2003 paper, saying that "the foreign pharmaceutical industry feels rather unwelcome in Korea", were unfounded. The feeling in our industry is however unchanged. Response to our 2003 paper has been limited to a partial reversal of the LTP system. The current situation confronting LTP is that it is being challenged in Korean courts of law and is in the view of industry, a contravention of the Korean constitution. However; as new issues in 2004 we must now add, the suggested application of Pharmaco-Economics, known from other countries to be extremely complex, the discriminatory introduction of the Drug Master File and the KFDA's unwillingness to accept internationally approved dissolution tests for Pharmaceutical Equivalence Testing (PET). Our paper, with those additions, therefore remains largely unchanged to that presented in 2003 and the preceding years. Our long running focus relates to Patient Access, Pricing and Reimbursement, because in this domain the authorities have targeted innovative, largely foreign products through cost containment measures ,whilst retaining an unusually high generic, largely local , pricing policy. Such measures have usually been implemented without any industry consultation or possibility for appeal. Overall, there remains a lack of transparency and an absence of true dialogue with industry. We fully understand the difficulties the Ministry of Health and Welfare has had in managing the insurance finance deficit, and the European pharmaceutical industry has offered to be a partner in addressing it in a fair and rational way. As expressed many times previously, we believe that the Korean government should look at ways to curtail the excessive prescribing of drugs and its unusually high generic pricing policy. We support the rational use of medicines, and emphasize that the quality of healthcare for the Korean patients should not be compromised. If the Korean government is serious about embracing the challenges of globalization and the development of a biotech hub for North East Asia, they will have to ensure that the environment for research-based industry becomes not only more attractive, but also more stable and predictable. The European pharmaceutical industry is willing to work with the Korean government and other stakeholders to ensure that such environment is created. In the specific context of the TBR complaint, some measures have been implemented, however only partially, whilst on others the government has started to backtrack. The TBR is still ongoing, Our Trade Issues are therefore, A. Patient and Physician Access. A1. Prescribing / Reimbursement Guidelines A2. Product Pricing a) A7 Pricing for Innovative New Products. b) ATP/ LTP c) Triennial Re-Pricing d) Pharmaco-Economics. B. Other Issues. B1. License Ownership (and Toll Manufacturing) B2. Cross Border Testing B3. Harmonization of Clinical Trials B4. Data Protection/IPR Issues B5. Drug Master File B6. Pharmaceutical Equivalence Testing (PET) 2 . Detail A1. Prescribing/Reimbursement Guidelines - Modern Medicine Restrictions Situation As a supplementary method to contain costs within the health care sector, prescribing/reimbursement guidelines for modern medicines have been implemented by the Korean Ministry of Health (MOHW) in association with the Health Insurance Review Agency (HIRA). Guidelines are developed within a financial framework focusing upon limiting access to modern medicines of international origin. Actual experience so far has shown that there appears to be little or no consideration given to sound medical or scientific rationale supporting guidelines. Additionally, industry is not permitted to engage in consultation with the guideline drug committee in order to challenge guideline validity. It is the opinion of industry that constituent members of the drug evaluation committee do not possess necessary medical competency in each specialty field to judge or recommend guidelines. Industry also believes that scant attention is paid to recommendations made by expert committees, as their opinion is more clinically focused and not financially driven. Potential prescribers of modern medicines are severely restricted in selection of the most appropriate therapy options and similarly are threatened that use of modern medicines will negatively impact hospital drug reimbursement. =C2=B7 Drug Utilization Review Committee (DUR): The only 2003 modification to the above is the creation of a "Drug Utilization Review Committee". Situation MOHW's has decided to set up from January 2004 under HIRA responsibility, a DUR committee for the purpose to promote an appropriate drug usage by carrying out development and implementation of guidelines for drug use evaluation How it will compliment the existing guidelines has not yet been defined, however; the committee will probably establish itself as the prima vehicle responsible for setting the new prescribing rules. The extent of and method of industry participation is not yet clear. Recommendation Although we do not oppose the principle of DUR committee, we would like to emphasize that the drug utilization review should be made purely on a scientific basis, and not on cost. In this light, we have concerns about the proposed composition of the DUR Committee membership, as industry participation is currently omitted. Furthermore scope of responsibilities of the DUR Committee and their implementation process are not clearly explained in the draft regulations Finally, we would like to suggest that relevant stakeholders, including industry, be given the opportunity to review and comment on the outcome of the DUR Committee. We also believe that results of the DUR studies will have to be informed to relevant stakeholders for feedback in a clear and timely manner. EUCCK will endeavor to seek dialogue with HIRA and MOHW to clearly understand the operational activities of the DUR and its consultation objectives with industry. =E2=97=8F A2. Product Pricing =C2=B7 A7 Pricing Situation The Korean authorities originally accepted to define prices of innovative medicines as the average of the prices in 7 countries (France, Germany, Italy, Japan, Switzerland, UK and US) as set forth in the MOHW Notification No 2001-17, revised on April 18,2001. However, as "innovative" has never been precisely defined and needs to be agreed for each product, this qualification remains up to the arbitrary decision of those bodies charged with the responsibility of defining whether a product attains the classification of "innovative", and in fact, it is a way not to apply A7 pricing in most of the cases. Indeed there are only few products that have received A7 pricing according to the interpretation of industry. Furthermore when the innovative qualification is rejected, pharmaceutical companies do not have the possibility to express and develop officially their positions until price publication. However generics remain premium priced (80% of originals), provided they can demonstrate bio-equivalence which in real terms, should be a pre-requisite for public healthcare interest. This demonstrates indirectly the lack of reward for R&D innovation in Korea. Recommendation A7 Pricing should be correctly implemented for all products approved as a new drug by the Commissioner of the Korea Food and Drug Administration in accordance with Article 2, Paragraph 12 under the Pharmaceutical Affairs Act, and if it is either a patented or PMS protected preparation, without any exception. It should be agreed within a short period of time, Otherwise there is also no logic in applying the rule of triennial re-re-pricing based on A7, if A7 average is not granted at the initial stage. Full implementation of A7 pricing creates a win-win for government, society and industry. For government, it can rely on the policy of 7 developed countries. Most of these countries already have a thorough evaluation process to define the price of a new pharmaceutical, whereby they take several criteria into account. This allows the Korean government to avoid duplication and to devote its resources to other needs. Linked to triennial re-pricing, it also allows government to adapt prices to a changing environment. For society, the early access to new products will have advantages in terms of health for the Korean citizens. For both local and foreign industry it creates predictability on prices and a smooth introduction of new products. It also creates an incentive for R&D investment through rewards for innovation by Korean Authorities =C2=B7 ATP / LTP Situation The Korean authorities originally introduced Actual Transaction Pricing in November 1999. In 2003 Government moved to LTP, Lowest (found) Transaction Price that they had to withdraw after one implementation, due to major opposition of all stakeholders especially as it could cause irreparable damages to the industry. Several litigations against MOHW are still on going by local and foreign companies. Initial findings suggest that the action may be unconstitutional however; the final court ruling will establish what constitutional issues are breeched. Consequently MOHW announced that after one implementation of LTP they would come back to ATP. So far, in spite of strong assertions to the contrary ATP has never been fully implemented in its original spirit, as the representativeness of the surveyed transaction remain more than questionable. Furthermore, companies are facing price reductions as a consequence of transaction clearly beyond their control i.e. discount practices from wholesalers to pharmacies or to other wholesalers Also financial discounts implemented to shorten payment term have been at the origin of price cuts whereas they should be out of the scope of the ATP surveys. Recommendation Industry supports ATP, because in combination with SDP (separation of dispensing and prescribing), it ensures a more efficient use of health insurance funds. The purpose of reimbursement is to alleviate the financial burden of patients, not to provide an income for the healthcare provider. Healthcare providers should be paid for the services provided. Therefore, ATP should be fully implemented first and then evaluated. There should be regular control of prescribers /dispensers, and penalties should target all those who do not comply with the provisions. Those products incorrectly re-priced under the single LTP application should revert to their original pricing. =C2=B7 Triennial Re-pricing Situation In October 2003 MOHW implemented the second round of triennial A7 average price revision. Recommendation Industry does not oppose triennial re-pricing if implemented in a fair way. The intention is to fully ensure A7 implementation, and it is consistent with the average A7 pricing. Thus changes should be allowed both up and down, and not only price reductions. There should be full implementation of A7 comparisons, with both up and downward adjustments. These adjustments should equally apply to original products and generics, without discrimination in favor of lower reductions for generics. =C2=B7 Pharmaco-Economics: Situation In industrialized countries, budget constraints and growing public demand for higher levels of healthcare have made the efficient delivery of high quality healthcare a major priority. Researches into the economic assessment of drugs known as pharmaco-economics have been conducted since the 1970's. In Korea utilization of pharmaco-economics could provide a tool to assist with drug registration, evaluation of clinical treatment guidelines, and evaluation of pharmaceutical care services, budget planning and pricing decision. EUCCK welcomes the Korean government willingness to utilize pharmaco-economics in its decisions related to healthcare policy. We do believe that an appropriate utilization of pharmaco-economics can have positive impact on healthcare policy. Pharmaco-economics can help optimize the utilization of healthcare resources, which is its primary goal. It can also assist MOHW in anticipating the budgetary impact of its decisions. European companies involved in healthcare are very eager to cooperate with authorities in the implementation of a transparent policy clearly oriented towards rationalization of resources and improvement of health care in Korea. Improving cost efficiency ratio of healthcare policy is a legitimate goal. One should keep in mind, however, that improving this ratio but not reducing cost of healthcare is the legitimate goal. Rationalization of healthcare delivery but not it cost reduction are the usual effect of pharmacoeconomics. Accordingly, pharmacoeconomics cannot and should not be used as an alibi for drugs prices limitation or reduction. Other countries have found direct application of pharmacoeconomics to the calculation of drug prices to be difficult. The potential applicability of pharmacoeconomics to the calculation of price of new drugs is still under investigation and debate. Average prices of drugs in Korea are the lowest amongst OECD countries even after adjustment for purchasing power parity. Analysis shows that total expenditures in pharmaceuticals as a share of GDP are in Korea much below the average of other industrialized counties. These facts do not restrain the potential benefits of pharmacoeconomics to the Korean healthcare system. It does reinforce the conclusion that rather than using pharmacoeconomics to simply determine drug prices, a broader application in relation for example, to guidelines, on proper use of healthcare should be made. Recommendation Industry does not oppose in principle but it is essential to ensure that Pharmaco-economic studies are used for the right reasons i.e. to promote a cost-effectiveness approach of drug utilization and not price control. Simultaneously the Government should be prepared to give access to the industry of costing elements in order to be able to conduct such studies and analyses. In our opinion, the key to a positive impact of pharmacoeconomics in healthcare policy is threefold: =C2=B7 The setting of clearly defined and appropriate objectives. =C2=B7 A consultation with all health care providers at every step =C2=B7 A quasi-judicial process with fair public hearing and clear decision criteria B1. Product License Ownership and Toll Manufacture Situation Under the current regulations, it is impossible for a non-manufacturer or a research institute in Korea, to acquire a product license for a locally manufactured product. They are required to license the product to a KGMP approved manufacturer and have experienced difficulties to regain ownership of the product if they plan to cancel such license agreement at a later stage. Therefore, toll manufacturing, which is a well established international practice allowing non manufacturing companies or research institutes to use the services of GMP approved manufacturers without entering into a license agreements is not possible in Korea. KFDA has taken up this issue because of approaches made by the Korean biotechnology industry where Korean R&D firms and institutes are in the process of developing new products but do not have production capabilities. KFDA has planned to propose separation of product and manufacturing licenses and thus allow toll manufacture, but its implementation remains to be seen. Recommendation The government should support the KFDA initiative and quickly implement the separation of product and manufacturing licenses for all pharmaceutical products (not only biologicals). This will encourage foreign companies to have their products produced locally and not to import them as finished products. In addition, it will encourage local manufacturing companies to invest in / and improve their facilities. B2. Cross Border Testing Situation During the registration process of imported products, KFDA require from the local importer, in addition to foreign test results, local test results of 3 batches of a new product. Quality inspection is subsequently carried out by the government for the first shipment only. These requirements are acceptable. However, after launch, importers must continue to repeat full testing on each imported batch of biological and non-biological products and keep locally prepared Certificates of Analysis (CoA) on file. This testing should follow the complete approved Testing Specification (TS), not just testing for identity, content and, if possible, sterility. This regulation is burdensome, particularly for imported biological products, but also for some modern, chemical-based products, for which required modern testing methods are not yet available in Korea. KFDA insist that the importers must use local testing facilities in Korea. This is often impossible or highly expensive to be built up. Recommendation As the legal responsibility for the continuous quality of a product lies with the manufacturer, not the importer, The CoA of an overseas GMP certified manufacturer should be accepted. KFDA may want to inspect and approve such manufacturer. If local retesting is required it should be limited to identity, content and sterility (if necessary). B3. Harmonization of Clinical Trials / Bridging Studies Situation There is a continuous disagreement between the Industry and KFDA about the need for a Bridging Study prior to registration of a new product. International standards (ICH E5) exist for the evaluation of clinical data related to potential differences in safety or efficacy of a drug due to ethnic differences. The KFDA continues to interpret ICH-E5 differently from most other countries requiring Korean ethnic data to prove ethnic insensitivity regardless of a compound's characteristics or regardless if it has been proven in other ethnic (e.g., Chinese or Japanese) groups that ethnic differences do not exist. A taskforce between KFDA and industry set up guidelines for extrapolating foreign clinical data. However, problems continued to occur due to differing interpretation of the principle and guidelines by different reviewer and nonscientific approach by KFDA. After the recent changes in the review body in KFDA, interpretations have become even stricter again and a Bridging Study is required in almost all cases. This results in unnecessary additional clinical trials that add expenses and delay introduction of innovative medicines to patients. This is an additional trade barrier for the international research based companies. Recommendation KFDA should follow the international ICH5-E5 practices. B 4. Data Protection/IPR Issues Situation Korea has not implemented specific provisions for data protection or TRIPS compliance. Instead, there is a system of re-examination, which in theory should afford much the same level of protection as formal data protection legislation. However, this obligation has been ignored by the Korean Food and Drug Administration (KFDA) in the licensing of generic products related to certain patented medicines from international companies. Thus, several generic products have been registered despite the existing patented products. Resolution of such instances is handled by litigation which is costly and time consuming and de facto allows erosion of the patent period. In addition there are instances in which the originator's technical data of the sponsor's file have apparently been used by generic competitors to gain such registration. In these instances, injured parties are disinclined to pursue legal proceedings against the KFDA, relying as they do, on KFDA officials for the issuance of other product licenses. There also seems to be a continued misunderstanding by the KFDA of its obligations under TRIPs Article 39.3 with regard to the use of clinical data from published journal articles. Generic products have been able to gain registration during the re-examination period even though the data in the studies cited were the property of the originator. KFDA claim that the TRIPs protection prevents use of publicly disclosed data only for "commercial purposes". Foreign companies in Korea, however, assert that registration is clearly intended for a commercial purpose. Recommendation The Korean Government should implement a prospective system for the administration of patent protection in pharmaceuticals, including directly linking the relevant product registration review (KFDA) and patent (KIPO) agencies for appropriate enforcement of patent protection. KFDA should also recognize that the purpose of securing a registration is clearly commercial. KFDA should also recognize that it has a clear obligation to ensure that data provided to it in pursuit of Regulatory Review require "right of use" certification and in addition are secure from misuse by third parties. Enforcement of the KFDA responsibility in this critical area needs strengthening, perhaps by appointment of an independent ombudsman to receive confidential complaints and to conduct inquiries. B5.Drug Master File ( DMF ) Situation The requirement for DMF was introduced in July 2002 to active pharmaceutical ingredients to improve and assure the quality of used in pharmaceutical products in Korea. The research based industry supports this in principle. However, data requirements were ambiguous and excessive, and DMF has only been required so far for new products. This is totally against the original intention of DMF. KFDA has accepted this as problem and a Taskforce (TF) with industry has been set up. This TF has made an explanatory booklet for the guide and Q&A book and proposed a revision to the current guideline. The TF has been dissolved in July 2003 and but no revised guideline has been published so far. KFDA was supposed to extend DMF to 99 active pharmaceutical ingredients by mid 2004, but implementation is still under question. If this is not implemented, DMF will remain a major trade issue of discrimination. Recommendation Implement DMF impartially and implement revisions as suggested by the TF. B6. Pharmaceutical Equivalence Testing ( PET ) Situation For filing of a new product registration, and in case of any changes in an existing product, e.g. composition, source of supply etc., KFDA require Pharmaceutical Equivalence Testing ( PET ) to show the dissolution profile of a new product. In case of an existing product for which changes have been requested, comparative dissolution profiles are required and this is a requirement in many countries and companies have developed their own testing specification specific for their particular products. Results from these tests are generally accepted. However, in Korea, KFDA insist on their own different testing methods which have to be uniformly used. This is impossible for some products and requires companies to repeat PET for all their products for Korea. Recommendation KFDA to accept internationally accepted dissolution testing (PET). -- James Love | Consumer Project on Technology http://www.cptech.org | mailto:james.love@cptech.org P.O. Box 19367, Washington, DC 200036 voice +1.202.387.8030 | fax +1.202.234.5176 From james.love@cptech.org Tue Nov 9 08:19:02 2004 From: james.love@cptech.org (James Love) Date: Tue Nov 9 08:19:02 2004 Subject: [Ip-health] For Jordan In-Reply-To: <20040902203417.31295.qmail@web52202.mail.yahoo.com> References: <20040902203417.31295.qmail@web52202.mail.yahoo.com> Message-ID: <4190C355.8060803@cptech.org> Dear Jordan, Over the past several months you have posted a steady stream of interesting and relevant messages about the WHO prequalification issue, and other regulatory issues concerning generic AIDS drugs. Some list members have asked about you. While we do not have a formal policy on this, most people who post to the list provide some affiliationor other information to provide some identification for the other list members. This is encouraged. Jamie -- James Love | Consumer Project on Technology http://www.cptech.org | mailto:james.love@cptech.org P.O. Box 19367, Washington, DC 200036 voice +1.202.387.8030 | fax +1.202.234.5176 From mpalmedo@cptech.org Tue Nov 9 11:01:02 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Tue Nov 9 11:01:02 2004 Subject: [Ip-health] MSF statement on EC proposal for export of generics to developing countries Message-ID: <4190E8E7.2040902@cptech.org> http://www.accessmed-msf.org/prod/publications.asp?scntid=3D91120041030362&= contenttype=3DPARA& MSF statement on European Commission=92s proposal for facilitating export of generic medicines to developing countries October 29, 2004: M=E9decins Sans Fronti=E8res is encouraged to see a proposal by the European Commission that sets out rules to allow the export from the European Union of generic medicines to developing countries. This proposal sends a positive message to developing countries which would benefit from using compulsory licensing to access affordable versions of needed medicines and other health care products. The proposal aims to implement the World Trade Organization=92s decision of August 30, a compromise which was needlessly complex. While the Commission=92s proposal does not reduce that complexity, we are encouraged that it does not include any new restrictions on which medicines or diseases it applies to (as has happened, for example, in Canada). However, we regret that the proposal requires prior negotiations with the patent holder, which will inevitably delay the swift use of the mechanism. Further, we note that the proposal includes an exemption from data exclusivity rules to allow the rapid registration of generic medicines by drug regulatory authorities when a compulsory license is issued. We hope that this could set a precedent for countries that are presently forced under regional or bilateral trade agreements to introduce data protection rules that hamper the registration of generic medicines. Whether this mechanism will be effective depends in part on the willingness of the European generics industry to make use of it. Now increased funding for the purchase of essential medicines is becoming available, we hope they will do so. Most seriously, however, even in the most optimistic scenario, this mechanism will do little to deal with the effects of the full implementation of the WTO TRIPS Agreement, which should be completed by January 1 2005. None of the existing TRIPS flexibilities will be sufficient over time to counter the effects of a world in which pharmaceutical products may be patented in every country. From james.love@cptech.org Tue Nov 9 14:13:00 2004 From: james.love@cptech.org (James Love) Date: Tue Nov 9 14:13:00 2004 Subject: [Ip-health] Long and bizarre Genentech patent application Message-ID: <41911514.5060706@cptech.org> -------- Original Message -------- Subject: PATNEWS: Long and bizarre Genentech patent application Date: Tue, 9 Nov 2004 02:33:06 -0500 From: patnews@ns1.patenting-art.com !20041109 Long and bizarre Genentech patent application ==================== - LONG AND BIZARRE GENENTECH PATENT APPLICATION Some sarcasm from a PATNEWS reader: Greg, I also don't know how you feel about Biotech patents. This one from Genentech is incredible: WO2004060270 Compositions and methods for the treatment of tumor http://v3.espacenet.com/textdoc?DB=EPODOC&IDX=WO2004060270 Here are the claims IN non-jargon for your readers: We claim 4622 sequences from a public database. We claim all common uses for these 4622 sequences which we don't own. We claim products which we never generated or identified. We claim treatments which we never tried. Oh yeah, we have absolutely no results and nothing new to show you. PS we took 5454 pages to tell you this. ==================== From james.love@cptech.org Tue Nov 9 14:34:00 2004 From: james.love@cptech.org (James Love) Date: Tue Nov 9 14:34:00 2004 Subject: [Ip-health] Gov't says it will not mandate deposition of research on open access Message-ID: <419119AA.90801@cptech.org> http://www.biomedcentral.com/news/20041109/02 November 9, 2004 UK setback for open access Gov't says it will not mandate deposition of research on open access repositories | By Stephen Pincock The British government has largely rejected the advice of a parliamentary committee that had urged it to support more open access to scientific research, saying on Monday (November 8) that it has no plans to require researchers to deposit copies of their publications in free-access repositories. In July this year, the House of Commons Select Committee on Science and Technology published a report on the status and future of scientific publishing in the United Kingdom. Its deliberations drew in part on an ongoing debate over "open access" to research, whose advocates say that the output from scientific endeavor should be freely available. The committee's report made many recommendations, including that the UK government fund the establishment of a network of institutional repositories where all research articles originating in the United Kingdom should be deposited and could be read for free: "In order to ensure that the repositories are well populated, we have recommended that research councils mandate their funded researchers to deposit copies of all their articles in this way." But the government's response makes clear that while it sees the value of such repositories, it "has no present intention to mandate Research Council=96funded researchers to deposit a copy of their published material in institutional repositories." The committee members immediately labeled the government's response as obstructive and questioned whether the Department of Trade and Industry (DTI), which compiled the document, had watered down the views of other government departments and bodies. "The Department of Trade and Industry has clearly tried to 'neutralize' the views put forward by other departments and Government-funded organizations, in particular the Joint Information Systems Committee (JISC), an expert advisory body funded indirectly by the Department for Education and Skills," the committee members said in a press statement. A spokesman for the DTI told The Scientist that the department was surprised by the statements from the Select Committee. "We submitted a response to their report in the normal way and consulted all the relevant people in government," he said. "JISC and other bodies saw a final draft of the response and as far as we were aware were content with it." The members of the committee are also unhappy that the government's response focused on criticism of the "author-pays" publishing model, "despite the fact that the committee's report did not recommend its wholesale adoption." Moreover, they say, the government has prejudged the publishing model, instead of encouraging experimentation. Ian Gibson, chair of the committee, said in a statement: "DTI is apparently more interested in kowtowing to the powerful publishing lobby than it is in looking after the best interests of British science. This isn't evidence-based policy, it's policy-based evidence. For Stevan Harnad, a long-time advocate of open access, the government's response is "not so much disappointing as delaying." Harnad agreed with the committee's assessment, saying that "the government has declined to implement the select committee's recommendations because they have been persuaded by DTI (who were persuaded by the publisher lobby) that the report recommends mandating OA (author-pays) publishing, whereas it does no such thing: it recommends mandating institutional self-archiving of UK-funded research publications (articles)." "This misconstrual=85 is a result of the excess verbiage continuously devoted to publishing reform, instead of the access provision that this is all really about," Harnad told The Scientist. On the other hand, the Royal Society, Britain's national academy of science, welcomed the government's report. "As one of many learned societies which rely on the income from its journals to fund core activities for science in the UK, the Royal Society supports the Government's intention to avoid any action that might threaten the viability of such societies," a spokesman said. The Royal Society commended the government's caution with respect to institutional repositories, too. "In particular, the emphasis put on the importance of academic journals in providing quality assurance through peer-review and the decision not to mandate researchers who are funded by Research Councils to deposit their papers in institutional repositories.= " Meanwhile, Harnad said that he has every hope that Research Councils UK (RCUK) will still implement the original UK select committee recommendation "in all its glory." He noted that something similar is happening in the United States, where the National Institutes of Health is moving ahead toward implementation of a related proposal, without waiting for the US Congress and Senate to agree on a law. A spokesman for RCUK confirmed that the government's response did not prevent the research councils from implementing the recommendations if they so chose. But a decision on the matter may be some time off, he told The Scientist, as RCUK is in the process of formulating its position on open access and probably won't be finished doing so until some time in early 2005. Links for this article "MPs condemn government response to scientific publications report," Science and Technology Committee press notice, November 8, 2004. http://www.parliament.uk/parliamentary_committees/science_and_t echnology_committee/scitech081104.cfm House of Commons Select Committee on Science and Technology Fourteenth Report http://www.publications.parliament.uk/pa/cm200304/cmselect/cmsc tech/1200/120006.htm#a1 S. Pincock, "UK committee backs open access," The Scientist, July 20, 2004. http://www.biomedcentral.com/news/20040720/04/ Research Councils UK http://www.rcuk.ac.uk P. Park, "NIH unveils open access draft," The Scientist, September 8, 2004. http://www.biomedcentral.com/news/20040908/04/ -- James Love | Consumer Project on Technology http://www.cptech.org | mailto:james.love@cptech.org P.O. Box 19367, Washington, DC 200036 voice +1.202.387.8030 | fax +1.202.234.5176 From jwkckid1@ix.netcom.com Wed Nov 10 09:57:01 2004 From: jwkckid1@ix.netcom.com (Jeff Williams) Date: Wed Nov 10 09:57:01 2004 Subject: [Ip-health] Long and bizarre Genentech patent application References: <41911514.5060706@cptech.org> Message-ID: <4191A9F5.A26218E8@ix.netcom.com> Jamie and all, One might also want to check out the legal status of this patent. See: http://v3.espacenet.com/legal?DB=EPODOC&IDX=WO2004060270&QPN=WO2004060270 It seems that WIPO is fully aware... As such, this brings up some questions as to WIPO's supposed change in attitude it is publicly pronouncing vs what is is actually doing... James Love wrote: > -------- Original Message -------- > Subject: PATNEWS: Long and bizarre Genentech patent application > Date: Tue, 9 Nov 2004 02:33:06 -0500 > From: patnews@ns1.patenting-art.com > > !20041109 Long and bizarre Genentech patent application > > ==================== > > - LONG AND BIZARRE GENENTECH PATENT APPLICATION > > Some sarcasm from a PATNEWS reader: > > Greg, > I also don't know how you feel about Biotech patents. This one > from Genentech is incredible: > > WO2004060270 > Compositions and methods for the treatment of tumor > http://v3.espacenet.com/textdoc?DB=EPODOC&IDX=WO2004060270 > > Here are the claims IN non-jargon for your readers: > > We claim 4622 sequences from a public database. > > We claim all common uses for these 4622 sequences which we > don't own. > > We claim products which we never generated or identified. > > We claim treatments which we never tried. > > Oh yeah, we have absolutely no results and nothing new to show you. > > PS we took 5454 pages to tell you this. > > ==================== > > _______________________________________________ > Ip-health mailing list > Ip-health@lists.essential.org > http://lists.essential.org/mailman/listinfo/ip-health Regards, -- Jeffrey A. Williams Spokesman for INEGroup LLA. - (Over 134k members/stakeholders strong!) "Be precise in the use of words and expect precision from others" - Pierre Abelard "If the probability be called P; the injury, L; and the burden, B; liability depends upon whether B is less than L multiplied by P: i.e., whether B is less than PL." United States v. Carroll Towing (159 F.2d 169 [2d Cir. 1947] =============================================================== Updated 1/26/04 CSO/DIR. Internet Network Eng. SR. Eng. Network data security IDNS. div. of Information Network Eng. INEG. INC. E-Mail jwkckid1@ix.netcom.com Registered Email addr with the USPS Contact Number: 214-244-4827 From jwkckid1@ix.netcom.com Wed Nov 10 09:57:09 2004 From: jwkckid1@ix.netcom.com (Jeff Williams) Date: Wed Nov 10 09:57:09 2004 Subject: [Ip-health] Big Pharma Bites Back Against Negative Headlines Message-ID: <4191BAE0.2A0921EF@ix.netcom.com> All, An interesting read and different view.. See: http://www.forbes.com/2004/11/05/cx_pk_1105roundupbiotech.html Regards, -- Jeffrey A. Williams Spokesman for INEGroup LLA. - (Over 134k members/stakeholders strong!) "Be precise in the use of words and expect precision from others" - Pierre Abelard "If the probability be called P; the injury, L; and the burden, B; liability depends upon whether B is less than L multiplied by P: i.e., whether B is less than PL." United States v. Carroll Towing (159 F.2d 169 [2d Cir. 1947] =============================================================== Updated 1/26/04 CSO/DIR. Internet Network Eng. SR. Eng. Network data security IDNS. div. of Information Network Eng. INEG. INC. E-Mail jwkckid1@ix.netcom.com Registered Email addr with the USPS Contact Number: 214-244-4827 From mpalmedo@cptech.org Wed Nov 10 10:53:01 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Wed Nov 10 10:53:01 2004 Subject: [Ip-health] WHO press release on Ranbaxy's withdrawl of ARVs from prequalification Message-ID: <419232CD.3010307@cptech.org> http://www.who.int/mediacentre/news/releases/2004/pr79/en/print.html Ranbaxy withdraws all its antiretroviral medicines from WHO prequalification 9 NOVEMBER 2004 | GENEVA -- Ranbaxy Laboratories Limited India has informed the World Health Organization (WHO) that it is voluntarily withdrawing all its antiretrovirals (all the product dossiers under assessment and all prequalified products) from WHO prequalification. This action was taken after the company found discrepancies in the documentation relating to proof of the products' bioequivalence with originator medicines. The company has already presented WHO with a plan indicating proposed dates for the submission of new study reports for these products. The first study is expected to be completed by December 2004. The seven prequalified medicines Ranbaxy is withdrawing are: Indinavir 400 mg capsule, blister (60, 100); Lamivudine 150 mg tablet, blister (60, 100); Lamivudine/Stavudine 150 mg/40 mg tablet, Al strip (10), 60 in box; Lamivudine/Stavudine 150 mg/30 mg tablet, Al strip (10), 60 in box; Nevirapine 200 mg tablet, blister (60, 100); Stavudine 30 mg capsule, Al strip (10), 60 in box; Zidovudine 300 mg tablet, blister (60, 100). Ranbaxy's voluntary withdrawal follows this year's removal by WHO of three other antiretroviral medicines manufactured by Ranbaxy and two antiretroviral medicines manufactured by Cipla, from the list of prequalified products. WHO removed these medicines from the list after inspections at the Contract Research Organizations (CROs) which conducted bioequivalence studies revealed serious discrepancies between the original results compiled by the CROs and the results presented to WHO, and non-compliance with international guidelines on Good Clinical Practices and Good Laboratory Practices. Following the removal of these products from the list, WHO sent a warning letter to all manufacturers of HIV/AIDS medicines participating in the prequalification project. The letter urged companies to verify the data they had submitted to WHO, as well as compliance with Good Clinical Practices and Good Laboratory Practices at the sites where bioequivalence studies had been conducted. In principle, patients should suspend the use of de-listed medicines and switch to other prequalified products. However, in many cases it will be difficult to find alternative prequalified products immediately. In this situation it is recommended that patients continue the use of de-listed products, as the risk of withholding treatment is higher than that of providing medicines whose bioequivalence is not proven but which have otherwise been prequalified. A switch to non-prequalified products is not recommended as their quality has not been documented by WHO. Information on the practical implications of the withdrawal of the above-mentioned products from the list of prequalified products for treatment programmes can be accessed on the WHO prequalification project web site, where the list of alternative products prequalified by WHO may also be found. There currently remain 89 products on the WHO prequalified list, 54 of which are antiretrovirals for the treatment of HIV/AIDS. For more information contact: Daniela Bagozzi Telephone: +41 22 791 4544 Email: bagozzid@who.int From KateEvans@newyork.msf.org Wed Nov 10 12:20:02 2004 From: KateEvans@newyork.msf.org (Kate Evans) Date: Wed Nov 10 12:20:02 2004 Subject: [Ip-health] MSF Responds to Shortages of Novartis Malaria Drug Coartem by WHO Message-ID: This is a multipart message in MIME format. -- [ Picked text/plain from multipart/alternative ] For Immediate Release Doctors Without Borders/Medecins Sans Frontieres (MSF) Responds to Shortages of Novartis Malaria Drug Coartem Announced by the World Health Organization Geneva, November 10, 2004 --On November 8, the World Health Organization (WHO) communicated misinformation regarding reasons for current shortages of the malaria drug artemether-lumefantrine (sole supplier Novartis, under the trade name Coartem). In addition, the WHO failed to point out that there are alternatives to Coartem available that are already being procured by both WHO and UNICEF.* The current demand for Coartem is not a surprise, as WHO suggests in their communication of November 8. WHO makes quarterly forecasts to Novartis, as stipulated in their 2001 agreement, and Novartis has known about this year?s demand since spring. Novartis needs to take responsibility for its failure to produce product according to WHO forecasts. It is in breach of its 2001 agreement with WHO to make ?all reasonable efforts? to produce quantities forecasted by WHO and should be held accountable. Novartis has failed to effectively organize its suppliers for this product, which has left the company vulnerable to capacity problems. Novartis? own estimate of current global raw material availability is 50 tons. Yet the company is failing to produce monthly quantities of Coartem that would require only 5 tons of raw material. This Novartis/WHO failure has serious consequences for people in African countries. For example, Novartis will only be able to supply one million out of the three million doses needed by Ethiopia. The rest of the patients will be forced to take a complex seven-day regimen, which is often not completed, leading to treatment failure. The good news is that three other companies have been validated by WHO/UNICEF to sell other WHO-recommended artemisinin-based combination therapies (?ACT?). The three other suppliers are Sanofi of France, and IPCA and Cipla of India. WHO/UNICEF should also be working with these producers to ensure that all ACT capacity is mobilized. For next year, there is a global shortage of ACTs looming and the only way to avoid this is for the international community to make advance purchases from multiple suppliers. Advance purchases will increase quantities of Artemisia annua that will be planted in December 2004/January 2005. This is the only way to ensure dramatically increased supplies for next year. Although WHO/UNICEF and the Global Fund agree that advance purchases are necessary, no actions have yet been taken. * ?Surge in Demand Leads to Shortage of Artemisinin-Based Combination Therapy for Malaria,? WHO press release, 8 November 2004. For more information, contact Kris Torgeson, +1-212-655-3764 or Kevin Phelan, +1-212-655-3763 or +1-646-201-8230. ___________________________________________________________ Kate Evans Program Associate, Campaign for Access to Essential Medicines Doctors Without Borders/Medecins Sans Frontieres (MSF) 333 7th Ave, 2nd Floor *New York, NY *10001-5004*USA Tel: +1-212-655-3773 Fax: +1-212-679-7016 E-mail: kate.evans@newyork.msf.org http://www.doctorswithoutborders.org http://www.accessmed-msf.org From mpalmedo@cptech.org Wed Nov 10 12:29:03 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Wed Nov 10 12:29:03 2004 Subject: [Ip-health] UK Parl. Sci & Tech Committee - MPs Condemn Government Response to Scientific Publications Report Message-ID: <41924F9A.6040107@cptech.org> http://www.parliament.uk/parliamentary_committees/science_and_technology_co= mmittee/scitech081104.cfm SCIENCE AND TECHNOLOGY COMMITTEE No. 81 of Session 2003-04 8 November 2004 MPs CONDEMN GOVERNMENT RESPONSE TO SCIENTIFIC PUBLICATIONS REPORT MPs on the House of Commons Science and Technology Select Committee have today, Monday 8 November, asked the Government to =93reconsider its position=94 on scientific publications after it released an obstructive Response to a Committee Report released in July this year. The MPs say that the Department of Trade and Industry (DTI) has clearly tried to =93neutralise=94 the views put forward by other departments and Government-funded organisations, in particular the Joint Information Systems Committee (JISC), an expert advisory body funded indirectly by the Department for Education and Skills. The MPs said it was =93worrying=94 both that an expert body had felt constrained in carrying out its advisory role, and that the Government had ignored JISC=92s expert advice on the need for change in the system for publishing research findings. JISC=92s very positive response to the Committee Report was watered down following negotiations with DTI. The Government Response focuses on criticism of the =93author-pays=94 publishing model, despite the fact that the Committee=92s Report did not recommend its wholesale adoption. Moreover, the Government has =93prejudged=94 the publishing model, instead of encouraging experimentatio= n as advocated by the Committee. MPs claim that the Government=92s position owes more to the publishing interests supported by DTI than the best interests of the scientific community or evidence-based policy. Ian Gibson MP, Chair of the Committee, said: =93DTI is apparently more interested in kowtowing to the powerful publishing lobby than it is in looking after the best interests of British science. This isn't evidence-based policy, it's policy-based evidence. =93The DTI are clearly wearing the Government's trousers on this issue and that's wrong. Not only has it ignored the advice of the body appointed to advise on this issue, it has actually tried to stop them giving us this advice directly, just because they support the Committee's conclusions rather than the DTI view.=94 Notes to editors =95 Under the terms of Standing Order No. 152 the Science and Technology Committee is empowered to examine the =93expenditure, policy and administration of the Office of Science and Technology and its associated public bodies=94. The Committee was appointed on 12 November 200= 1. =95 The Committee=92s inquiry into Scientific Publications was announced on 10 December 2003 in Press Notice 3 of Session 2003-04. The Committee took evidence from Blackwell Publishing, John Wiley & Sons, Nature Publishing Group and Reed Elsevier on 1 March 2004; Oxford University Press, the Institute of Physics Publishing, the Association of Learned and Professional Society Publishers, BioMed Central, Public Library of Science and Axiope on 8 March 2004; the British Library, the Joint Information Systems Committee, Cambridge University Library, the University of Hertfordshire and a panel of academics on 21 April 2004; and the Department of Trade and Industry/the Office of Science and Technology, the Higher Education Funding Council for England and Research Councils UK on 5 May 2004. =95 The Committee published its findings as the Tenth Report of session 2003-04 Scientific Publications: Free for all? (HC 399), on Tuesday 20 July 2004. =95 This Report is published alongside the Government Response and responses from the Joint Information Systems Committee, RCUK, the Office of Fair Trading, the Society of College, National and University Libraries/the Consortium of University Research Libraries and the Securing a Hybrid Environment for Research Preservation and Access project. From mpalmedo@cptech.org Wed Nov 10 15:43:00 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Wed Nov 10 15:43:00 2004 Subject: [Ip-health] EU strengthens fight against piracy and counterfeiting beyond its borders Message-ID: <41926ECA.1090501@cptech.org> http://europa.eu.int/comm/trade/issues/sectoral/intell_property/pr101104_en= .htm EU strengthens fight against piracy and counterfeiting beyond its borders DG Trade press release Brussels, 10 November 2004 In an effort to halt the increase in piracy and counterfeiting the European Commission has today adopted a strategy for the enforcement of intellectual property rights (IPR) in third countries. The action plan focuses on vigorous and effective implementation and enforcement of existing IPR laws. It proposes to identify priority countries where enforcement actions should be concentrated. Stress will be put on technical cooperation and assistance to help third countries fight counterfeiting but the Commission will not hesitate to trigger all bilateral and multilateral sanction mechanisms against any country involved in systematic violations. The Commission will foster awareness raising of users and consumers in third countries and support the creation of public-private partnerships for enforcement. EU Trade Commissioner Pascal Lamy said: "Piracy and counterfeiting continue to grow every year and have become industries, increasingly run by criminal organisations. This is a serious problem for us but also for third countries whose companies are also suffering the consequences of violation of their own intellectual property rights". He added: "Some of these fakes, like pharmaceuticals and foodstuffs constitute an outright danger to the public, while others undermine the survival of EU=92s most innovative sectors, confronted with the misappropriation of their creations. Adopting new legislation on intellectual property is one thing. But devising the right tools to enforce it is another. This is now our priority". This Strategy sets the guidelines for the European Commission in the coming years towards a reduction of the level of IPR violations taking place beyond the EU borders, worldwide. It follows a logical sequence of recent initiatives taken by the EU to tackle this problem within the EU and at its border. It is not the EU purpose to re-invent the wheel, but to show that we are committed to work more and better in an area where putting in place legislation is not sufficient. It is essential that third countries accompany the commitments agreed to in the WTO and in bilateral agreements by a genuine willingness to tackle the problem at their borders, in their courts, and in their streets. From our part, we must ensure that our right-holders are effectively protected against the misappropriation of their property and our citizens in general against the dangers of piracy and counterfeiting. The Strategy in detail: 1. Identifying priority countries: EU action will focus on the most problematic countries in terms of IPR violations. These countries will be identified according to a regular survey to be conducted by the Commission among all stakeholders. 2. Awareness raising: promote initiatives to raise public awareness about the impact of counterfeiting (loss of foreign investment and technology transfer, risks to health, link with organised crime, etc.) and make available to the public and to the authorities of third countries concerned a "Guidebook on Enforcement of Intellectual Property Rights". 3. Political dialogue, incentives and technical co-operation: ensuring that technical assistance provided to third countries focuses on IPR enforcement, especially in priority countries; exchanging ideas and information with other key providers of technical co-operation, like the World Intellectual Property Organisation (WIPO), the US or Japan, with the aim of avoiding duplication of efforts and sharing of best-practices. 4. IPR mechanisms in multilateral (including TRIPs), bi-regional and bilateral agreements: raising enforcement concerns in the framework of these agreements more systematically; consulting trading partners with the aim of launching an initiative in the WTO TRIPs Council, sounding the alert on the growing dimension of the problem, identifying the causes and proposing solutions and strengthening IPR enforcement clauses in bilateral agreements. 5. Dispute settlement - sanctions: recall the possibility that right-holders have to make use of the Trade Barriers Regulation or of bilateral agreements, in cases of evidence of violations of TRIPs; in addition to the WTO dispute settlement, recall the possibility to use dispute settlement mechanisms included in bilateral agreements in case of non-compliance with the required standards of IPR protection. 6. Creation of public-private partnerships: supporting/participating in local IP networks established in relevant third countries; using mechanisms already put in place by Commission services (IPR Help Desk and Innovation Relay Centres) to exchange information with right-holders and associations; build on the co-operation with companies and associations that are very active in the fight against piracy/counterfeiting. From access@msf.org.br Wed Nov 10 15:43:07 2004 From: access@msf.org.br (access@msf.org.br) Date: Wed Nov 10 15:43:07 2004 Subject: [Ip-health] taxotere and article 70.9 in Brazil - patent on this product somewhere ? Message-ID: <007101c4c75f$7b98f9a0$1c01a8c0@MichelL> This is a multi-part message in MIME format. -- [ Picked text/plain from multipart/alternative ] Thanks for your answers on this issue. After consultation, there is a possibility of challenging the way the EMRs certificate was issued by sending a formal request at INPI on the grounds that - the Certificate is confused and not exact. We need to know if there is anywhere in the world a patent o taxotere (patent of product). From what we know, there is a patent of process in Argentina. But for the 70.9 to be effective in granting EMRs, there should be a patent on the product somewhere. Anyone can help ? Also, the patent was initially requested as a process in 7th july 1995 (during the mailbox period) , than a few years later it was changed to patent for product as the Brazilian mailbox didn't recognize patent for process. In the certificate it is said that the patent request for product..... was filed on 7th of july 1995, while actually the patent for product was changed after 1999 ! Brazilian NGOs will send the formal letter to request cancelation or modification of this EMR certificate so that it will just become a certificate that says that a patent request has been filed...but without reference to article 70.9 . I -- From wak22@comcast.net Wed Nov 10 15:43:16 2004 From: wak22@comcast.net (wak22@comcast.net) Date: Wed Nov 10 15:43:16 2004 Subject: [Ip-health] Genentech patent application... Message-ID: <111020042028.12037.419279DD00027EC400002F052207001641CDCD050E99@comcast.net> -- [ Picked text/plain from multipart/alternative ] Dear ip-health: I did not bother to look at this Genentech document, as I have spent way to= o many years writing similar things for other companies. However, on a tech= nical note, it is a patent application, NOT an issued patent as the number = .WO2004060270 identifies it as an application. It is certainly possible (= although we have no way of knowing at present) that none of these claims w= ill be ever be allowed, anywhere.... Warren Kaplan, Ph.D, JD, MPH Center for International Health and Development Boston University School of Public Health 85 E. Concord St. Boston, MA From mpalmedo@cptech.org Wed Nov 10 15:43:24 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Wed Nov 10 15:43:24 2004 Subject: [Ip-health] WSJ letters to editor on open-access publishing Message-ID: <41927C6E.3070508@cptech.org> The letters below are in response to an October 28 story, which is online here: http://online.wsj.com/article_print/0,,SB109890431840357445,00.html ------------------------------------------------------------------------------ http://online.wsj.com/opinion/letters?mod=2_0048 LETTERS TO THE EDITOR: Should Access to Medical Research Be Free? Bringing quality science to the public is a laudable goal, but the government and scholarly publishers alike must be careful ("Journals Resist Free Access to Medical Data," Oct. 28). The National Institutes for Health proposal for free access to research articles should be carefully studied for its potential effect on the quality and quantity of research and the possibility of unintended consequences. For example, the push could shutter many scholarly journals that operate on the edge of profitability or at a loss, underwritten by organizations like mine that believe in and invest in knowledge dissemination to advance science and for the public good. A decrease in the number of dissemination outlets available to researchers would decrease the exchange of science information rather than increase it. In addition, public access to journal articles will do little to help the average consumer understand the latest scientific finding because researchers write in a complex technical language. Federal energies would be better spent creating public information products that the public can easily understand and put to use. Norman B. Anderson, Ph.D. Chief Executive Officer American Psychological Association Washington -------------------------------------- BioMed Central believes that open access to research is central to rapid and efficient progress in science and that subscription-based access to research is hindering rather than helping scientific communication. Indeed, we have already published online more than 6,500 research articles. While there's no doubt that traditional publishers do claim that U.S. taxpayers will ultimately pay for the NIH plan, isn't it also true that most of the current subscription income of the very same publishers ultimately also comes from taxpayers, via the many university and other publicly funded libraries? Jan Velterop Director and Publisher BioMed Central Ltd. London -------------------------------------- As a result of voluntary actions by publishers of scientific journals, more information is available to more people than ever before. Many journals make their content free online, and others are investing substantial resources to make archival issues available. Patients have free access to abstracts and can request free copies of articles from most of these publishers. Scholarly publishers oppose mandatory government-imposed rules, they have pointed out major flaws in the NIH proposal and they question a plan that would jeopardize their successful efforts to increase access in favor of an untested proposal created by people who have never successfully published a journal. Paul W. Kincade President Federation of American Societies for Experimental Biology Bethesda, Md. From michael.davis@law.csuohio.edu Wed Nov 10 16:05:02 2004 From: michael.davis@law.csuohio.edu (michael.davis@law.csuohio.edu) Date: Wed Nov 10 16:05:02 2004 Subject: [Ip-health] Genentech patent application... In-Reply-To: <111020042028.12037.419279DD00027EC400002F052207001641CDCD050E99@comca st.net> References: <111020042028.12037.419279DD00027EC400002F052207001641CDCD050E99@comcast.net> Message-ID: <64495.68.167.71.122.1100120036.squirrel@68.167.71.122> There is some merit to this warning, but it must be examined in light of the fact that almost every patent application is eventually granted. Just as it was repeated in the 60s that any competent prosecutor could get an indictment against a ham sandwich, it is equally true today that any competent patent attorney can get a patent on one too. While it is possible that some of these claims will be denied, it is not credibly possible that none of them will ever be allowed. > -- > [ Picked text/plain from multipart/alternative ] > Dear ip-health: > > I did not bother to look at this Genentech document, as I have spent way > too many years writing similar things for other companies. However, on a > technical note, it is a patent application, NOT an issued patent as the > number .WO2004060270 identifies it as an application. It is certainly > possible (although we have no way of knowing at present) that none of > these claims will be ever be allowed, anywhere.... > > Warren Kaplan, Ph.D, JD, MPH > Center for International Health and Development > Boston University School of Public Health > 85 E. Concord St. > Boston, MA > _______________________________________________ > Ip-health mailing list > Ip-health@lists.essential.org > http://lists.essential.org/mailman/listinfo/ip-health > Mickey Davis _________________________________ Prof. Michael H. Davis Professor of Law Cleveland State Univ. College of Law 1801 Euclid Ave. Cleveland, OH 44115-2214 (mailing address: 2121 Euclid Ave. LB 234) 216-687-2228 _____________________________________________________________ Patent Attorney Admitted to Practice Before the US Patent and Trademark Office Reg.No. 45,863 From mpalmedo@cptech.org Wed Nov 10 16:05:12 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Wed Nov 10 16:05:12 2004 Subject: [Ip-health] UK House of Commons Sci & Tech Committee report on access to scientific journals Message-ID: <419280FD.4070801@cptech.org> http://www.publications.parliament.uk/pa/cm200304/cmselect/cmsctech/399/399= .pdf House of Commons - Science and Technology Committee Scientific Publications: Free for all? Tenth Report of Session 2003-04 Summary Academic libraries are struggling to purchase subscriptions to all the journal titles needed by their users. This is due both to the high and increasing journal prices imposed by commercial publishers and the inadequacy of library budgets to meet the demands placed upon them by a system supporting an ever increasing volume of research. Whilst there are a number of measures that can be taken by publishers, libraries and academics to improve the provision of scientific publications, a Government strategy is urgently needed. This Report recommends that all UK higher education institutions establish institutional repositories on which their published output can be stored and from which it can be read, free of charge, online. It also recommends that Research Councils and other Government funders mandate their funded researchers to deposit a copy of all of their articles in this way. The Government will need to appoint a central body to oversee the implementation of the repositories; to help with networking; and to ensure compliance with the technical standards needed to provide maximum functionality. Set=96up and running costs are relatively low, making institutional repositories a cost=96effective way of improving access to scientific publications. Institutional repositories will help to improve access to journals but a more radical solution may be required in the long term. Early indications suggest that the author=96pays publishing model could be viable. We remain unconvinced by many of the arguments mounted against it. Nonetheless, this Report concludes that further experimentation is necessary, particularly to establish the impact that a change of publishing models would have on learned societies and in respect of the =93free rider=94 problem. In order to encourage such experimentation the Report recommends that the Research Councils each establish a fund to which their funded researchers can apply should they wish to pay to publish. The UK Government has failed to respond to issues surrounding scientific publications in a coherent manner and we are not convinced that it would be ready to deal with any changes to the publishing process. The Report recommends that Government formulate a strategy for future action as a matter of urgency. The preservation of digital material is an expensive process that poses a significant technical challenge. This Report recommends that the British Library receives sufficient funding to enable it to carry out this work. It also recommends that work on new regulations for the legal deposit of non=96print publications begins immediately. Failure to take these steps would result in a substantial breach in the intellectual record of the UK. The market for scientific publications is international. The UK cannot act alone. For this reason we recommended that the UK Government act as a proponent for change on the international stage and lead by example. This will ultimately benefit researchers across the globe. [snip] From jbanerji@dndi.org Fri Nov 12 09:26:01 2004 From: jbanerji@dndi.org (Jaya Banerji) Date: Fri Nov 12 09:26:01 2004 Subject: [Ip-health] DNDi Press Release: The Gap is Growing - More Resources Needed Now for Neglected Diseases Message-ID: <200411110022500.SM00446@JB> This is a multi-part message in MIME format. -- [ Picked text/plain from multipart/alternative ] Would appreciate it if you would post this DNDi press release on the ip-health list. Many thanks, Jaya Jaya Banerji Communications Manager Drugs for Neglected Diseases Initiative 1, Place St.Gervais, 1201 Geneva, Switzerland Tel: +41 22 906 9230 Tel (Direct): +41 22 906 9234 Fax: +41 22 906 9231 ---------------------------------------------------------------------------- ---------------------------------------------------------------------------- -------------------------------------- The gap is growing: More resources needed now for neglected diseases Geneva, 11 November 2004 Two important conferences convene this month that will decide the future of patients suffering from neglected diseases in the poorer countries of the world: The Ministerial Summit on Health Research, November 16-20 in Mexico City, and the Dutch Government / WHO "Priority Medicines for the Citizens of Europe and the World" meeting, 18 November in The Hague. The lives of neglected patients hang in the balance. Will they be promised life in the form of new drugs or be left to suffer their fate? Ten years ago, the world spent US$30 billion on health research of which under10 per cent was spent on 90 per cent of the world's health problems - a disparity known as the "10/90 gap". Today global spend on health research has more than tripled to under US$106 billion, yet the amount allocated to the R&D for drugs to treat 90 per cent of the global disease burden has risen by a mere US$0.3-0.5 billion to around US$3.5 billion, mainly due to contributions from private foundations, governments, and charities. Thus, the 10/90 gap doesn't just persist, in percentage terms it shows alarming growth over the last decade. Patients continue to suffer from neglected diseases such as tuberculosis, malaria, leishmaniasis and human African trypanosomiasis (sleeping sickness), and continue to be treated with old, ineffective, and sometimes toxic drugs. The pipeline of drugs for neglected diseases is virtually empty. From 1975 to 1999 of the 1393 new drugs marketed only 13, or a mere one per cent, were for tropical diseases. This imbalance is unacceptable in the second millennium. The Drugs for Neglected Diseases Initiative is working to help restore the balance. Its current portfolio of projects targets the most neglected diseases, such as sleeping sickness, leishmaniasis, and Chagas disease. "For leishmaniasis, for example, we have four projects currently researching novel compounds that could kill the parasite that causes this deadly disease. Another project is investigating possible combinations of existing anti-leishmanial drugs. In addition, we are launching clinical trials of the anti-leishmanial drug paromomycin for registration in Africa," said DNDi's Executive Director Bernard Pecoul. "If we are to achieve our aim to bring new, field-adapted treatments to neglected patients, we will need increased commitment from governments and industry." ---------------------------------------------------------------------------- --------------- Old drugs to treat leishmaniasis Today, the leishmaniases are endemic in 88 countries including those in Latin America. An estimated 350 million people are at risk. It has been estimated that 12 million people are affected by this group of diseases with around 1.5 to 2 million new cases occurring annually; and this number is rising. Pentavalent antimony, the most widely prescribed drug to treat Leishmania patients, was discovered a century ago, has serious side effects, requires prolonged course of treatment and is losing its efficacy in some regions due to increasing parasite resistance. Although newer treatments exist, they are not optimal due to development of resistance, problems of toxicity, high price and difficulty in administration. Co-infection with HIV poses an additional challenge. ---------------------------------------------------------------------------- --------------------------------------------------- The traditional system of drug research and development has proved inadequate for neglected diseases. These diseases are causing increasing mortality and morbidity in the poorer countries of the world; but as they have little commercial value and promise no returns on investment, the research and development of new medicines for these neglected diseases has little or no priority. DNDi believes that the responsibility for public health lies at the door of governments. The technical and financial support of affluent governments, access to the industry's cutting-edge R&D facilities, as well as the support of scientists in the field of infectious tropical diseases will be essential if drug development projects are to progress through the pipeline and new drugs see the light of day. The lives of millions suffering from neglected diseases depend on the deliberations and conclusions of the Mexico summit and the Hague meeting. DNDi urges governments to seriously consider the following: * Invest more in neglected diseases including sustained support for initiatives involved in developing affordable, effective, field-adapted drugs for diseases that fall outside the realm of market forces. This should also be accompanied by the transfer of technology to disease-endemic regions. o Encourage the translation of existing basic research into molecules that can be tested in patients. o Strengthen existing capacities in neglected disease endemic regions to facilitate clinical trials. o Secure the market for, and thus the use of, new medicines. * Encourage industry to be more engaged in neglected diseases and to find innovative ways to share their enormous resources, expertise, laboratories, and compound databases. "Access to the technological expertise and research facilities of industry is crucial but without the solid support of governments we will not be able to push our drug development projects through the pipeline," said Bernard Pecoul. For additional information on DNDi, or interviews, please contact: Jaya Banerji, DNDi Communications Manager, Geneva. Mobile: +41 79 210 9378, jbanerji@dndi.org Michel Lotrowska, DNDi Regional Liaison Office, Rio de Janeiro. Mobile: +5521-8111-3-666, access@msf.org.br -- From wak22@comcast.net Fri Nov 12 09:26:08 2004 From: wak22@comcast.net (Warren Kaplan) Date: Fri Nov 12 09:26:08 2004 Subject: [Ip-health] Genentech patent application...and the polypill References: <111020042028.12037.419279DD00027EC400002F052207001641CDCD050E99@comcast.net> <419315A7.24065FA2@ix.netcom.com> Message-ID: <001701c4c7e4$4f4aa760$6401a8c0@D2LYLJ31> Jeff and all: Although the Genentech application might not issue in its present form with all claims intact, in reality some claims will surely issue from this patent application but we cannot at this time know what they will look like. On your other point, perhaps there ARE certain patent applications that we should look out for before grant. One example is the application by Wald and Law; GB 2361 185 A (Pharmaceutical formulation for the prevention of cardiovascular disease). This is a British application with a U.S. counterpart filing and a worldwide "PCT" filing. The claims cover the so-called "polypill", a potentially very important fixed dose combinationmedication comprising a blood pressure lowering medication, a lipid lowering medication, and aspirin. Although their article in the British Medical Journal (326:1419) included the idea of treating everyone over 55 with this polypill for PRIMARY prevention of cardiovascular disease - this is controversial. However, its use in secondary prevention of cardiovascular disease is less so. The fact that each component is already, or will soon be, in generic form, makes this an attractive public health advance and all the more curious to find a patent application on this subject matter. My instincts tell me it will be difficult to get broad patent claims to a polypill but maybe to a specific commercial embodiment?. That would be unfortunate. Warren Kaplan, Ph.D, JD, MPH Center for International Health and Development Boston University School of Public Health Boston, MA ----- Original Message ----- From: "Jeff Williams" To: Cc: Sent: Thursday, November 11, 2004 2:32 AM Subject: Re: [Ip-health] Genentech patent application... > Warren and all, > > Exactly right. Thank you Warren for the clarification... >:) > > It would seem that there are some that are overly concerned about > certain classes of patent applications, even before they are granted... > > wak22@comcast.net wrote: > >> -- >> [ Picked text/plain from multipart/alternative ] >> Dear ip-health: >> >> I did not bother to look at this Genentech document, as I have spent way >> too many years writing similar things for other companies. However, on a >> technical note, it is a patent application, NOT an issued patent as the >> number .WO2004060270 identifies it as an application. It is certainly >> possible (although we have no way of knowing at present) that none of >> these claims will be ever be allowed, anywhere.... >> >> Warren Kaplan, Ph.D, JD, MPH >> Center for International Health and Development >> Boston University School of Public Health >> 85 E. Concord St. >> Boston, MA >> _______________________________________________ >> Ip-health mailing list >> Ip-health@lists.essential.org >> http://lists.essential.org/mailman/listinfo/ip-health > > Regards, > > -- > Jeffrey A. Williams > Spokesman for INEGroup LLA. - (Over 134k members/stakeholders strong!) > "Be precise in the use of words and expect precision from others" - > Pierre Abelard > > "If the probability be called P; the injury, L; and the burden, B; > liability depends upon whether B is less than L multiplied by > P: i.e., whether B is less than PL." > United States v. Carroll Towing (159 F.2d 169 [2d Cir. 1947] > =============================================================== > Updated 1/26/04 > CSO/DIR. Internet Network Eng. SR. Eng. Network data security > IDNS. div. of Information Network Eng. INEG. INC. > E-Mail jwkckid1@ix.netcom.com > Registered Email addr with the USPS > Contact Number: 214-244-4827 > > > From KateEvans@newyork.msf.org Fri Nov 12 09:26:17 2004 From: KateEvans@newyork.msf.org (Kate Evans) Date: Fri Nov 12 09:26:17 2004 Subject: [Ip-health] NYT: In Health Care, Gap Between Rich and Poor Persists, WHO Says Message-ID: This is a multipart message in MIME format. -- -- [ Picked text/plain from multipart/alternative ] MSF will participate in the Ministerial Summit on Health Research taking place next week; we will circulate our briefing paper and press release on R&D for neglected diseases once they are available. Also, I've included a link to the WHO report released yesterday at the bottom of the article. November 11, 2004 In Health Care, Gap Between Rich and Poor Persists, W.H.O. Says By ELISABETH MALKIN EXICO CITY, Nov. 10 - Despite significant gains in medical science, disparities in public health persist between rich and poor countries, the World Health Organization said in a report released here on Wednesday. The report, released in advance of a W.H.O. meeting here next week of health ministers from 30 countries, called for more research into how health care is delivered. . "Half of the world's deaths could be prevented with simple and cost-effective interventions," said the report. "But not enough is known about how to make these more widely available to the people who need them," it continued. The study said that inadequate health systems in developing countries had been a constraint in global programs to fights AIDS, tuberculosis and malaria. "Countries with few resources struggle with creaking infrastructure, inadequate financing, migrating doctors and nurses and lack of basic information on health indicators," the study's authors concluded. The study pointed to market reforms in the health sector, promoted by the World Bank in the 1980's, as one reason for steadily weakening public health systems in developing countries. The push toward privatization might have accentuated disparities in the health care available to rich and poor, the report said. It also pointed to "gross inequities in the research process at both global and national levels" and said treatments in the developing world must be tailored to local conditions. For example, the report cited a study in Haiti that found that babies born to mothers treated with antiretroviral drugs to prevent the transmission of H.I.V. might then die of congenital syphilis. A second report released here on Wednesday, by the Global Forum for Health Research, a Geneva-based nonprofit group, found that spending on health research rose from $84.9 billion in 1998 to $105.9 billion in 2001. Despite this, there has been little headway in closing the gap between rich and poor countries in financing for research into the infectious diseases that disproportionately affect developing countries, like malaria and tuberculosis, the report said. The Global Forum, which will hold its own meeting parallel to the W.H.O. conference, said that less than 10 percent of spending on health research goes to study 90 percent of the world's diseases. "Very few infectious diseases are getting sufficient attention," said Stephen Matlin, the group's executive director. "They remain neglected diseases." Pharmaceutical companies account for 48 percent of the spending for medical research, reflecting in part the increased cost of bringing a drug to market. The public sector, led by rising budgets at the National Institutes of Health in the United States, spends 44 percent of all research funds. Private foundations and universities account for the other 8 percent. Pharmaceutical companies are reluctant to release information about their research, Mr. Matlin said, but the evidence is that much of their spending goes to developing therapies for noncommunicable diseases prevalent in wealthier countries. Mr. Matlin pointed to mergers that have left the industry in the hands of a few companies and speculated that "it may be that larger companies are getting less innovative." "Our direct concern is to see an increase in spending on infectious diseases in low- and middle-income countries and to change priorities," he said. Link to WHO report: http://www.who.int/rpc/meetings/pub1/en/ -- [ Content of type image/gif deleted ] -- [ Content of type image/gif deleted ] From jwkckid1@ix.netcom.com Fri Nov 12 09:26:24 2004 From: jwkckid1@ix.netcom.com (Jeff Williams) Date: Fri Nov 12 09:26:24 2004 Subject: [Ip-health] Genentech patent application...and the polypill References: <111020042028.12037.419279DD00027EC400002F052207001641CDCD050E99@comcast.net> <419315A7.24065FA2@ix.netcom.com> <001701c4c7e4$4f4aa760$6401a8c0@D2LYLJ31> Message-ID: <41945DC5.59ADC715@ix.netcom.com> Warren and all, Warren, thank you for your attentive and very good comments/remarks. Much appreciated. It has been my and others notice that as far as the US patent office is concerned, over the past several years, the review process for patent applications has been far less than optimal or effective. With the flood of new patents in certain classes, to include those dealing with pharma. have not had the attention to detail as the Cenentech patent application seems to indicate. > Jeff and all: > > Although the Genentech application might not issue in its present form with > all claims intact, in reality some claims will surely issue from this patent > application but we cannot at this time know what they will look like. > > On your other point, perhaps there ARE certain patent applications that we > should look out for before grant. One example is the application by > Wald and Law; GB 2361 185 A (Pharmaceutical formulation for the prevention > of cardiovascular disease). This is a British application with a U.S. > counterpart filing and a worldwide "PCT" filing. The claims cover the > so-called "polypill", a potentially very important fixed dose > combinationmedication comprising a blood pressure lowering medication, a > lipid lowering medication, and aspirin. Although their article in the > British Medical Journal (326:1419) included the idea of treating everyone > over 55 with this polypill for PRIMARY prevention of cardiovascular > disease - this is controversial. However, its use in secondary prevention of > cardiovascular disease is less so. The fact that each component is already, > or will soon be, in generic form, makes this an attractive public health > advance and all the more curious to find a patent application on this > subject matter. > > My instincts tell me it will be difficult to get broad patent claims to a > polypill but maybe to a specific commercial embodiment?. That would be > unfortunate. > > Warren Kaplan, Ph.D, JD, MPH > Center for International Health and Development > Boston University School of Public Health > Boston, MA > > ----- Original Message ----- > From: "Jeff Williams" > To: > Cc: > Sent: Thursday, November 11, 2004 2:32 AM > Subject: Re: [Ip-health] Genentech patent application... > > > Warren and all, > > > > Exactly right. Thank you Warren for the clarification... >:) > > > > It would seem that there are some that are overly concerned about > > certain classes of patent applications, even before they are granted... > > > > wak22@comcast.net wrote: > > > >> -- > >> [ Picked text/plain from multipart/alternative ] > >> Dear ip-health: > >> > >> I did not bother to look at this Genentech document, as I have spent way > >> too many years writing similar things for other companies. However, on a > >> technical note, it is a patent application, NOT an issued patent as the > >> number .WO2004060270 identifies it as an application. It is certainly > >> possible (although we have no way of knowing at present) that none of > >> these claims will be ever be allowed, anywhere.... > >> > >> Warren Kaplan, Ph.D, JD, MPH > >> Center for International Health and Development > >> Boston University School of Public Health > >> 85 E. Concord St. > >> Boston, MA > >> _______________________________________________ > >> Ip-health mailing list > >> Ip-health@lists.essential.org > >> http://lists.essential.org/mailman/listinfo/ip-health > > > > Regards, > > > > -- > > Jeffrey A. Williams > > Spokesman for INEGroup LLA. - (Over 134k members/stakeholders strong!) > > "Be precise in the use of words and expect precision from others" - > > Pierre Abelard > > > > "If the probability be called P; the injury, L; and the burden, B; > > liability depends upon whether B is less than L multiplied by > > P: i.e., whether B is less than PL." > > United States v. Carroll Towing (159 F.2d 169 [2d Cir. 1947] > > =============================================================== > > Updated 1/26/04 > > CSO/DIR. Internet Network Eng. SR. Eng. Network data security > > IDNS. div. of Information Network Eng. INEG. INC. > > E-Mail jwkckid1@ix.netcom.com > > Registered Email addr with the USPS > > Contact Number: 214-244-4827 > > > > > > Regards, -- Jeffrey A. Williams Spokesman for INEGroup LLA. - (Over 134k members/stakeholders strong!) "Be precise in the use of words and expect precision from others" - Pierre Abelard "If the probability be called P; the injury, L; and the burden, B; liability depends upon whether B is less than L multiplied by P: i.e., whether B is less than PL." United States v. Carroll Towing (159 F.2d 169 [2d Cir. 1947] =============================================================== Updated 1/26/04 CSO/DIR. Internet Network Eng. SR. Eng. Network data security IDNS. div. of Information Network Eng. INEG. INC. E-Mail jwkckid1@ix.netcom.com Registered Email addr with the USPS Contact Number: 214-244-4827 From mpalmedo@cptech.org Fri Nov 12 10:02:00 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Fri Nov 12 10:02:00 2004 Subject: [Ip-health] PhRMA Launches Innovation.org Message-ID: <4194CCF4.4060507@cptech.org> PhRMA Launches Innovation.org November 10, 2004 Washington, D.C.=96 The Pharmaceutical Research and Manufacturers of America (PhRMA) announced the launch today of www.innovation.org, a new Web site that takes visitors inside the world of pharmaceutical discovery. The Web site offers, for the first time, a single resource providing a wealth of timely information and interactive features on the science, challenges, impact and future of pharmaceutical innovation. =93Pharmaceutical innovation has never held greater promise or faced greater challenges,=94 stated Alan F. Holmer, PhRMA president and CEO. =93Innovation.org offers a valuable new resource to understand why it is critical to support continued innovation in medicine. =93Serious diseases and conditions like diabetes, heart disease, cancer and Alzheimer=92s threaten to exact a growing toll, both human and financial, as our population ages,=94 Holmer added. =93New medicines represent an important solution in meeting this challenge and delivering affordable, high-quality health care in the years ahead.=94 Visitors to www.innovation.org can: * Meet researchers behind new medicines and patients who benefit from them; * Travel through a century of pharmaceutical discovery on an interactive timeline; * Discover how medicines are made and why pharmaceutical research and development is increasingly time consuming and uncertain; * Hear current debates and commentary from leading health care experts; * Learn about new medicines in development in the site=92s New Medicines database. The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country=92s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA members invested an estimated $33.2 billion in 2003 in discovering and developing new medicines. PhRMA companies are leading the way in the search for new cures. From mpalmedo@cptech.org Fri Nov 12 10:36:01 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Fri Nov 12 10:36:01 2004 Subject: [Ip-health] Economic Times: India Govt Caught Between Left & WTO onn Patents Bill Message-ID: <4194D3B6.4050407@cptech.org> http://economictimes.indiatimes.com/articleshow/921086.cms Govt caught between Left & WTO on Patents Bill ECONOMIC TIMES NEWS NETWORK NOVEMBER 12, 2004 NEW DELHI: The Left, which is opposing the Patents Amendment Bill, has once again asked the government not to pass the legislation in a hurry and sought a detailed examination by the Parliamentary panel. If the government agrees to the Left=92s demand, it may not be able to keep the WTO deadline of January 1, =9204. Sources in the government ruled out concessions for the Left on the issue, but promised to address their reservations in the amended Bill. In any case, the government has already secured the backing of the NDA for the Bill and can live with the Left=92s opposition. The four Left parties have sent an elaborate note to the Manmohan Singh government warning that the country may have to pay a =93heavy price=94 if it hastened through the legislation. The January 1 deadline for developing countries to provide for a TRIPS-compliant regime should not be used as a =93plea=94 to rush with the legislation, they said. They said it was necessary to solicit views of different sections, interest groups and experts as the Bill would have implications for pharmaceutical, agriculture, biotechnology and software sectors. The Left cautioned against the scope of patentability being unlimited, saying it would be impossible to stop the flood of patents and in the process, companies with resources and lawyers would have the ability to stake a claim on a large number of products and processes and stop competition. Agreeing with the Mashalkar Committee, the Left parties said the scope of patents should be limited to novel inventions. Quoting the report of the US Federal Trade Commission indicating that over 1,000 patent applications were filed daily, the Left said many frivolous claims had been admitted in the US as justice could not be done to all. Apprehending that a similar volume may get filed in India, it predicted that within five years, a million products could be under patent protection. =93This would have a serious impact on our industrial economy, creating spurious monopolies for otherwise common products for which people will have to pay high prices,=94 they said. The Left also cautioned about the prices of products in a patenting system with unrestricted scope. It warned that the government=92s health care programme may get affected pointing out that the prices of pharmaceuticals in India range from 1/20th to 1/100th of that in the US. The Left parties feel that the developed countries led by the US pressing for harmonisation of patent laws and consequent internationalisation of the patent system amounted to taking away the sovereign right of any country to have national patent laws and the consequences would be worse than the potential impact of the TRIPS agreement. The Left parties also said the =93data exclusivity=94 demand of the MNCs under TRIPS meant that they wanted to restrict the public disclosure aspect, which they feared implied de facto continuation of the monopoly of the existing patent holders, domestic enterprises not being able to duplicate even its own data for taking marketing approval and research institutions not having access to this data. The note said the demand for data exclusivity came through bilateral pressure from MNCs and the US. From james.love@cptech.org Fri Nov 12 10:36:08 2004 From: james.love@cptech.org (James Love) Date: Fri Nov 12 10:36:08 2004 Subject: [Ip-health] GoozNews Update: Furberg booted from FDA panel Message-ID: <4194D3FE.9080209@cptech.org> -------- Original Message -------- Subject: GoozNews Update: Furberg booted from FDA panel Date: Fri, 12 Nov 2004 07:06:36 -0700 From: merrill@gooznews.com (((((((((((( GoozNews Update: Furberg booted from FDA panel )))))))))))) November 12, 2004 ------------------------------------------------------------------------ http://www.gooznews.com/archives/000089.html ------------------------------------------------------------------------ The Wall Street Journal reports this morning that the Food and Drug Administration removed Dr. Curt Furberg of Wake Forest University from the panel that will evaluate the safety of Cox-2 painkillers next February. Sandra Kweder, the acting director of the agency's Center for Drug Evaluation and Research, claimed he was biased because he was quoted in a New York Times article suggesting that all Cox-2s may cause heart problems. Merck's Cox-2 Vioxx was pulled from the market late last month, prompting next February's meeting. The significance of this move can't be overstated. Dr. Furberg is the one of the nation's most independent, judicious voices in drug analysis. He was the intellectual godfather of the ALLHAT trial, which showed that generic diuretics were just as good as premium medicines for combating high blood pressure. That he would be booted from a panel for a single comment represents the height of hypocrisy by the FDA. The agency routinely grants conflict-of-interest waivers to industry-funded researchers so they can sit on panels evaluating medicines. More on this issue later . . . -- Powered by Movable Type Version 2.661 http://www.movabletype.org/ -- James Love | Consumer Project on Technology http://www.cptech.org | mailto:james.love@cptech.org P.O. Box 19367, Washington, DC 200036 voice +1.202.387.8030 | fax +1.202.234.5176 From act2@case.edu Fri Nov 12 10:36:18 2004 From: act2@case.edu (Alexander Tsai) Date: Fri Nov 12 10:36:18 2004 Subject: [Ip-health] NitroMed patent for preexisting drug for a new, race-specific indication Message-ID: <200411121504.DDE20704@mirapoint1.tis.cwru.edu> The New England Journal of Medicine recently published the results of the African-American Heart Failure Trial (AHeFT), in which they found that a fixed dose of both isosorbide dinitrate and hydralazine benefited black patients with advanced heart failure who were already receiving standard therapy for heart failure. The abstract can be found here: http://content.nejm.org/cgi/content/short/351/20/2049 There is an accompanying commentary by Gregg Bloche (subscription required): http://content.nejm.org/cgi/content/full/351/20/2035 "NitroMed's race-specific strategy promises another large business benefit. Two years ago, NitroMed obtained a second patent, this one based on the use of the formulation in blacks. This patent, the first ever granted to a preexisting drug for a new, race-specific use, pushes back potential market entry by generic sellers of the fixed-dose combination from 2007 to 2020." "The ease with which race can be used as a crude marker for clinically relevant biologic difference makes it attractive as a basis for bringing pharmaceutical products to market. But once a pharmaceutical firm has obtained patent protection and regulatory approval, it has little incentive to sponsor research aimed at elucidating the relevant genetic variations and their physiological manifestations. Indeed, such research risks shrinking the demand for a drug, by subtracting patients who lack the genetic markers that predict a good response. Such research is a classic "public good" in the economic sense: absent government support (or state-imposed obligation), it will tend to be undersupplied by market actors. And without the needed follow-up science, racial categories are at heightened risk of being reified as biologic." -- Alexander C. Tsai Case Western Reserve University From james.love@cptech.org Fri Nov 12 11:18:03 2004 From: james.love@cptech.org (James Love) Date: Fri Nov 12 11:18:03 2004 Subject: [Ip-health] Product that will test health registration data rules Message-ID: <4194DEC4.5090201@cptech.org> When this vaccine hits the market, every young woman should have access. They should not have to wait 5 years for the rights in registration data to expire. GSK should be addressing how this will be priced in developing countries, and if they cannot move toward an "access to medicine for all" approach, this should be a prime target for compulsory licensing. Jamie http://story.news.yahoo.com/news?tmpl=story&ncid=751&e=1&u=/nm/20041112/hl_nm/health_cancer_vaccine_dc Glaxo Vaccine Stops Virus Linked to Cancer -Study Fri Nov 12, 4:58 AM ET By Patricia Reaney LONDON (Reuters) - It's one of the most common cancers in women and kills about a quarter of a million patients each year but scientists said on Friday that a new vaccine could prevent most cases of cervical cancer. The researchers tested a vaccine that protects women against two strains of the human papillomavirus (HPV) which are linked to more than 70 percent of cervical cancer cases. The vaccine was developed by drugs giant GlaxoSmithKline Plc. "This is the first time we have shown that there is a vaccine that protects against the only cause of a cancer and we can actually prevent 70 percent of all cervical cancer worldwide," said Diane Harper, of Dartmouth Medical School in New Hampshire. But Harper added in an interview that larger trials with a longer follow-up time are needed to confirm the trial results. Each year 470,000 women are diagnosed with cervical cancer. If it is detected and treated early, survival rates are good. Eighty percent of deaths from the disease are in the developing world. Good results from the study had been expected after GSK said two weeks ago that it had pushed forward the filing date for worldwide regulatory approval for the vaccine, known as Cervarix, to 2006 from 2008. Merck and Co Inc is also working on a similar vaccine, which industry analysts say could be filed in the latter part of 2005. Adrian Howd, an analyst with ABN AMRO, said Cervarix was a "sleeper" product in GSK's new drug pipeline that had so far been given little value in market forecasts of the company's future revenues. He believes sales of Cervarix could eventually exceed 1 billion pounds ($1.84 billion), following its expected launch in 2007. Shares in GSK, Europe's largest drug maker, were 0.5 percent higher at 12.09 pounds at 0925 GMT, matching the European drugs sector. SEXUALLY TRANSMITTED Scientists agree that the best way to tackle the disease is a vaccine to prevent persistent infection with HPV, a sexually transmitted virus, and to combine it with a screening program. More than 75 percent of women are infected with HPV at some time during their lives but in most cases it only lasts for a short time and produces no symptoms. In research reported in The Lancet medical journal, Harper and her team tested the vaccine on 1,113 women, aged 15-25 years in the United States, Canada and Brazil. The women were randomly selected to receive three doses of the vaccine or a placebo and followed up for 27 months. The scientists said the vaccine was 91 percent effective against infection with HPV 16 and HPV 18 strains and provided 100 percent protection against persistent infections that can lead to cancer. "The vaccine was safe and had few side effects," Harper added. In a commentary in the journal, Matti Lehtinen of the National Pubic Health Institute in Finland and Jorma Paavonen, of the University of Helsinki, said the vaccine showed great promise. (Additional reporting by Ben Hirschler) ($1=.5436 Pound) From mpalmedo@cptech.org Fri Nov 12 12:23:01 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Fri Nov 12 12:23:01 2004 Subject: [Ip-health] Tufts University: Follow-On Drugs Improve Patient Safety and Help Reduce Costs Message-ID: <4194E3DB.2030808@cptech.org> http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=3D48 NEWS RELEASE Follow-On Drugs Improve Patient Safety and Help Reduce Costs, According to Tufts CSDD Center for the Study of Drug Development Tufts University 11/9/2004 BOSTON =96 Nov. 9, 2004 =96 Follow-on medicines, sometimes referred to as me-too drugs, provide therapeutic advantages over existing treatments and expand the opportunity to treat more patients with improved safety and efficacy at lower cost, according to an analysis recently completed by the Tufts Center for the Study of Drug Development. The Tufts CSDD study also found that the first drug within a therapeutic class to gain marketing approval in the U.S. by the Food and Drug Administration (FDA) is not necessarily the best drug within that class. =93Follow-on drugs result from a development race in which only one drug can be the first approval in a new therapeutic class,=94 said Tufts CSDD Director Kenneth I Kaitin. =93Far from being redundant, follow-on drugs create therapeutic alternatives, which enable physicians to individualize patient treatment.=94 He added that benefits of incremental innovation are similar to those that occur in other healthcare product categories, such as diagnostics, devices, vaccines, and in R&D for neglected diseases and rare illnesses. Kaitin said follow-on drugs increase product availability from multiple sources, creating competition that results in higher quality medicines at lower cost. For example, he said, the current monthly cost of statins launched in 2003 is 45 percent less than statins launched in the early 1990s, while the cost for ACE inhibitors (anti-hypertensives) launched in the mid-1990s is 72 percent less compared to the early 1980s. =93On average, one-third of all follow-on drugs in development receive a priority rating from the FDA, which indicates that they constitute a therapeutic advance over drugs already on the market,=94 said Kaitin. =93This strongly suggests that the first products to reach the pharmacy shelf may not be the safest or most efficacious.=94 The Tufts CSDD study also found that: * Nearly all follow-on drugs for classes where the first-in-class drug was approved in the 1990s were synthesized, had initial pharmacologic testing, and were in clinical testing somewhere in the world before the first-in-class drug was approved. * Effective market exclusivity period for first-in-class drugs dropped 78%, from an average of 8.2 years in the 1970s to 1.8 years in 1995-98. * A substantial number of late entering follow-on drugs had priority ratings. For the classes with four or more follow-on drugs, 48% of the follow-on drugs that had received a priority rating were the fourth or later follow-on. From Kevin.Outterson@mail.wvu.edu Fri Nov 12 14:45:01 2004 From: Kevin.Outterson@mail.wvu.edu (Kevin Outterson) Date: Fri Nov 12 14:45:01 2004 Subject: [Ip-health] Product that will test health registration data rules Message-ID: This is a MIME message. If you are reading this text, you may want to consider changing to a mail reader or gateway that understands how to properly handle MIME multipart messages. -- [ Picked text/plain from multipart/alternative ] Over 90% of GSK's global revenues are from the rich OECD countries. Why not purchase from GSK the non-OECD rights to this vaccine and place it into public domain for the rest of the world? The lost GSK revenues will be less than $200 million; the R&D cost recovery within that is around $30 - $35 million. Pay GSK $35 million for the non-OECD compulsory license and we have access without any damage to innovation. This paper will be presented next week in Mexico City at the WHO meeting. Kevin Outterson Associate Professor of Law West Virginia University 304 293 8282 kevin.outterson@mail.wvu.edu LL.M. (Cantab.) J.D. (Northwestern) SSRN Author Page: ssrn.com/author=340746 CONFIDENTIALITY STATEMENT The information transmitted is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any review, retransmission, dissemination or other use of, or taking of any action in reliance upon, this information by persons or entities other than the intended recipient or recipients is prohibited. If you received this in error, please contact the sender and delete the material from any computer. >>> James Love 11/12/2004 11:03:16 AM >>> When this vaccine hits the market, every young woman should have access. They should not have to wait 5 years for the rights in registration data to expire. GSK should be addressing how this will be priced in developing countries, and if they cannot move toward an "access to medicine for all" approach, this should be a prime target for compulsory licensing. Jamie http://story.news.yahoo.com/news?tmpl=story&ncid=751&e=1&u=/nm/20041112/hl_nm/health_cancer_vaccine_dc Glaxo Vaccine Stops Virus Linked to Cancer -Study Fri Nov 12, 4:58 AM ET By Patricia Reaney LONDON (Reuters) - It's one of the most common cancers in women and kills about a quarter of a million patients each year but scientists said on Friday that a new vaccine could prevent most cases of cervical cancer. The researchers tested a vaccine that protects women against two strains of the human papillomavirus (HPV) which are linked to more than 70 percent of cervical cancer cases. The vaccine was developed by drugs giant GlaxoSmithKline Plc. "This is the first time we have shown that there is a vaccine that protects against the only cause of a cancer and we can actually prevent 70 percent of all cervical cancer worldwide," said Diane Harper, of Dartmouth Medical School in New Hampshire. But Harper added in an interview that larger trials with a longer follow-up time are needed to confirm the trial results. Each year 470,000 women are diagnosed with cervical cancer. If it is detected and treated early, survival rates are good. Eighty percent of deaths from the disease are in the developing world. Good results from the study had been expected after GSK said two weeks ago that it had pushed forward the filing date for worldwide regulatory approval for the vaccine, known as Cervarix, to 2006 from 2008. Merck and Co Inc is also working on a similar vaccine, which industry analysts say could be filed in the latter part of 2005. Adrian Howd, an analyst with ABN AMRO, said Cervarix was a "sleeper" product in GSK's new drug pipeline that had so far been given little value in market forecasts of the company's future revenues. He believes sales of Cervarix could eventually exceed 1 billion pounds ($1.84 billion), following its expected launch in 2007. Shares in GSK, Europe's largest drug maker, were 0.5 percent higher at 12.09 pounds at 0925 GMT, matching the European drugs sector. SEXUALLY TRANSMITTED Scientists agree that the best way to tackle the disease is a vaccine to prevent persistent infection with HPV, a sexually transmitted virus, and to combine it with a screening program. More than 75 percent of women are infected with HPV at some time during their lives but in most cases it only lasts for a short time and produces no symptoms. In research reported in The Lancet medical journal, Harper and her team tested the vaccine on 1,113 women, aged 15-25 years in the United States, Canada and Brazil. The women were randomly selected to receive three doses of the vaccine or a placebo and followed up for 27 months. The scientists said the vaccine was 91 percent effective against infection with HPV 16 and HPV 18 strains and provided 100 percent protection against persistent infections that can lead to cancer. "The vaccine was safe and had few side effects," Harper added. In a commentary in the journal, Matti Lehtinen of the National Pubic Health Institute in Finland and Jorma Paavonen, of the University of Helsinki, said the vaccine showed great promise. (Additional reporting by Ben Hirschler) ($1=.5436 Pound) _______________________________________________ Ip-health mailing list Ip-health@lists.essential.org http://lists.essential.org/mailman/listinfo/ip-health From ahollis@ucalgary.ca Fri Nov 12 14:45:11 2004 From: ahollis@ucalgary.ca (Aidan Hollis) Date: Fri Nov 12 14:45:11 2004 Subject: [Ip-health] Hypertension compliance study in Ghana Message-ID: <00e401c4c8e6$9ebff4f0$9e15cecd@DH6JZL51> This article examines compliance by patients in Ghana with hypertension medicines. It reveals that non-compliance rates are very high (essentially 100%) for higher priced meds, while compliance is much better for the lowest cost medicines. http://www.ualberta.ca/~csps/JPPS7(3)/L.Matowe/hypertension.htm J Pharm Pharmaceut Sci (www.ualberta.ca/~csps) 7(3):350-352, 2004 Unaffordable drug prices: the major cause of non-compliance with hypertension medication in Ghana. Kwame Ohene Buabeng Department of Clinical and Social Pharmacy, Faculty of Pharmacy, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana Lloyd Matowe Department of Pharmacy Practice, Faculty of Pharmacy, Kuwait University, Kuwait Jacob Plange-Rhule Department of Medicine, School of Medical Sciences, Komfo-Anokye Teaching Hospital, Kumasi, Ghana Aidan Hollis Associate Professor Department of Economics University of Calgary 2500 University Dr NW Calgary Alberta T2N 1N4 Canada tel: 403 220 5861 fax: 403 282 5262 email: ahollis@ucalgary.ca web: http://econ.ucalgary.ca/hollis.htm From galk@free.fr Fri Nov 12 14:45:21 2004 From: galk@free.fr (krikorian gaelle) Date: Fri Nov 12 14:45:21 2004 Subject: [Ip-health] EU strengthens fight against piracy and counterfeiting beyond its borders In-Reply-To: <41926ECA.1090501@cptech.org> References: <41926ECA.1090501@cptech.org> Message-ID: is this some kind of EU "301 list" procedure? gaL On Nov 10, 2004, at 8:40 PM, Mike Palmedo wrote: > http://europa.eu.int/comm/trade/issues/sectoral/intell_property/ > pr101104_en.htm > > EU strengthens fight against piracy and counterfeiting beyond its > borders > > DG Trade press release > Brussels, 10 November 2004 > > In an effort to halt the increase in piracy and counterfeiting the > European Commission has today adopted a strategy for the enforcement of > intellectual property rights (IPR) in third countries. The action plan > focuses on vigorous and effective implementation and enforcement of > existing IPR laws. It proposes to identify priority countries where > enforcement actions should be concentrated. Stress will be put on > technical cooperation and assistance to help third countries fight > counterfeiting but the Commission will not hesitate to trigger all > bilateral and multilateral sanction mechanisms against any country > involved in systematic violations. The Commission will foster awareness > raising of users and consumers in third countries and support the > creation of public-private partnerships for enforcement. > > EU Trade Commissioner Pascal Lamy said: "Piracy and counterfeiting > continue to grow every year and have become industries, increasingly > run > by criminal organisations. This is a serious problem for us but also > for > third countries whose companies are also suffering the consequences of > violation of their own intellectual property rights". He added: "Some > of > these fakes, like pharmaceuticals and foodstuffs constitute an outright > danger to the public, while others undermine the survival of EU=92s most > innovative sectors, confronted with the misappropriation of their > creations. Adopting new legislation on intellectual property is one > thing. But devising the right tools to enforce it is another. This is > now our priority". > > This Strategy sets the guidelines for the European Commission in the > coming years towards a reduction of the level of IPR violations taking > place beyond the EU borders, worldwide. It follows a logical sequence > of > recent initiatives taken by the EU to tackle this problem within the EU > and at its border. > > It is not the EU purpose to re-invent the wheel, but to show that we > are > committed to work more and better in an area where putting in place > legislation is not sufficient. It is essential that third countries > accompany the commitments agreed to in the WTO and in bilateral > agreements by a genuine willingness to tackle the problem at their > borders, in their courts, and in their streets. From our part, we must > ensure that our right-holders are effectively protected against the > misappropriation of their property and our citizens in general against > the dangers of piracy and counterfeiting. > > The Strategy in detail: > > 1. Identifying priority countries: EU action will focus on the most > problematic countries in terms of IPR violations. These countries will > be identified according to a regular survey to be conducted by the > Commission among all stakeholders. > > 2. Awareness raising: promote initiatives to raise public awareness > about the impact of counterfeiting (loss of foreign investment and > technology transfer, risks to health, link with organised crime, etc.) > and make available to the public and to the authorities of third > countries concerned a "Guidebook on Enforcement of Intellectual > Property > Rights". > > 3. Political dialogue, incentives and technical co-operation: ensuring > that technical assistance provided to third countries focuses on IPR > enforcement, especially in priority countries; exchanging ideas and > information with other key providers of technical co-operation, like > the > World Intellectual Property Organisation (WIPO), the US or Japan, with > the aim of avoiding duplication of efforts and sharing of > best-practices. > > 4. IPR mechanisms in multilateral (including TRIPs), bi-regional and > bilateral agreements: raising enforcement concerns in the framework of > these agreements more systematically; consulting trading partners with > the aim of launching an initiative in the WTO TRIPs Council, sounding > the alert on the growing dimension of the problem, identifying the > causes and proposing solutions and strengthening IPR enforcement > clauses > in bilateral agreements. > > 5. Dispute settlement - sanctions: recall the possibility that > right-holders have to make use of the Trade Barriers Regulation or of > bilateral agreements, in cases of evidence of violations of TRIPs; in > addition to the WTO dispute settlement, recall the possibility to use > dispute settlement mechanisms included in bilateral agreements in case > of non-compliance with the required standards of IPR protection. > > 6. Creation of public-private partnerships: supporting/participating in > local IP networks established in relevant third countries; using > mechanisms already put in place by Commission services (IPR Help Desk > and Innovation Relay Centres) to exchange information with > right-holders > and associations; build on the co-operation with companies and > associations that are very active in the fight against > piracy/counterfeiting. > > > _______________________________________________ > Ip-health mailing list > Ip-health@lists.essential.org > http://lists.essential.org/mailman/listinfo/ip-health > From amy.kapczynski@yale.edu Mon Nov 15 05:22:29 2004 From: amy.kapczynski@yale.edu (Amy Kapczynski) Date: Mon Nov 15 05:22:29 2004 Subject: [Ip-health] NYT: Do New Drugs Always Have to Cost So Much? Message-ID: <679D9408-3674-11D9-9FD4-000A95D7D472@yale.edu> very interesting piece in today's NYT - -------- Do New Drugs Always Have to Cost So Much? By EDUARDO PORTER Published: November 14, 2004 Copyright the New York Times 2004 AMERICAN politicians are so perplexed about how to deal with prescription drug prices that the best solution they can offer is to effectively import a Canadian law - by buying drugs subject to Canadian government price controls - rather than pass one of their own. There are, however, more straightforward ways to get cheaper drugs than by borrowing price fixes from across the border. Some economists say the government can reduce pharmaceutical prices by changing how the nation pays for innovation. Prescription drugs are expensive by design. They cost a lot to invent but are relatively cheap to make, so companies receive patents from the government that grant them a monopoly and enable them to sell the medicine at a premium. In doing so, the idea goes, drug makers recoup their investments in research and development and are encouraged to invent more. But some economists say that there is no inexorable economic reason for drug prices to be as high as they are. "Patents are one way to get medical innovation, but they are not a fact of nature," said Michael R. Kremer, an economics professor at Harvard. "It is worth looking for alternatives." Strong patent protection has allowed substantial spending on innovation. American drug companies invested $33 billion in it last year, according to the Pharmaceutical Research and Manufacturers of America, a lobbying group. But this arrangement has a measurable economic cost, keeping drugs from consumers who would buy them if they were priced like other competitive commodities - marginally above production costs. That is not the only inefficiency that patents breed. In the insured health market, where neither patients nor their doctors actually pay for drugs, drug companies are subject to all manner of perverse incentives. For instance, they can reap more from investing in marginal improvements over existing therapies - and buying ads to persuade patients to pay big markups for them - than from investing in riskier, ground-breaking drugs. The Food and Drug Administration has classified only about 20 percent of the drugs developed over the last 10 years as qualitative breakthroughs. Even though they spend more on research, pharmaceutical companies are finding fewer new drugs. In a report this year, the F.D.A. said that the way drugs are developed "is becoming increasingly challenging, inefficient and costly." One alternative is to have the government pay directly for research, which some economists say could maintain innovation while reducing drug prices. The government already spends almost $30 billion a year on basic drug research at National Institutes of Health laboratories and at universities, much of which results in new drugs. It would be relatively straightforward to extend this to cover the research now done in drug company labs, economists say. There are other alternatives. For example, the government could compensate drug companies for their inventions as an incentive for them to keep innovating. How to determine how much an innovation is worth? One possibility would be for the government to selectively buy patents at a premium over the price a private bidder was willing to offer, and then put them into the public domain, Professor Kremer said. Aidan Hollis, an assistant professor of economics at the University of Calgary in Alberta, devised a different approach: the government would set up a fund to compensate drug companies based on how much their new drugs improve the quality of life and how often they were used. These alternatives would carry several benefits, economists say. In addition to making drugs available at lower prices, they would make it much less profitable for pharmaceutical companies to spend millions of dollars to develop drugs, like Nexium and Clarinex, that are protected by patents but offer little improvement over similar drugs already on the market. The goal is not to spend less to develop new drugs, Professor Hollis said, but to get more therapeutic bang for the buck - by channeling investment to where it matters most - as well as to increase access to the resulting drugs. "This can be done within the same budget as we devote to pharmaceuticals now," he said. There is an incentive for the government to seek ways to control drug costs. Through programs like Medicare and agencies like the Veterans Administration, its spending on prescription drugs is growing more than 10 percent a year and will hit $46 billion in 2004, almost one-fourth of the nation's total spending on these drugs, according to the Department of Health and Human Services. The expansion of Medicare's drug coverage will add more than $50 billion a year to the bill, on average, over the next decade. Drug companies, of course, do not like any of this. They have mustered lobbyists to oppose such ideas and have referred to research that supports strong patent protections. Patricia M. Danzon, a professor at the Wharton School at the University of Pennsylvania whose work is often cited by drug makers, said that lack of access to prescription drugs was not a big problem in the United States. Most Americans have health insurance with drug coverage, she said; for those who don't, the solution is to provide them with coverage - not to upend the patent system. "I'm not sure what all this gains us," she said of the call for reform. She added that "small adjustments in the patent system would be a more appropriate way to address" the investment in "me too" drugs. And changing the rules of the game might itself introduce inefficiency. Another critique, by Joseph A. DiMasi of Tufts University and Henry G. Grabowsky of Duke University, compared proposals for government rewards for research to the way the old Soviet Union gave prizes to its inventors. The Soviet "record of innovation was not impressive," they said. There are potential problems to be considered in the alternatives. Political decisions could skew government-financed research, misallocating investment. Governments short on cash may be tempted to underpay for private-sector invention, reducing companies' incentives to innovate. Auctions like the one proposed by Professor Kremer could be manipulated or undermined by corruption, while bids for patents might be low because most drugs would be sold as cheap generics. Pricing techniques like those proposed by Professor Hollis would require controversial decisions about issues like the monetary value of an extra month of life. Professor Kremer, Professor Hollis and others say their proposals will probably need to be tweaked. They could be made voluntary, for instance, letting companies keep their drugs out of a new system but providing enough rewards to entice them in. Other ideas should be explored and tested, too, they say, urging policy makers to remember the main point: the current system is not working well. "The pharmaceutical market is probably the worst-functioning market that there is," Professor Hollis said. SO what's the chance it will change? Last month, Representative Dennis J. Kucinich of Ohio, who sought the Democratic presidential nomination this year, introduced a bill in the House to essentially replace drug patents with direct government financing of research. But even Dean Baker, co-director of the Center for Economic and Policy Research, who advised Mr. Kucinich on the idea, is skeptical of the bill's prospects. "Today all of these proposals are going nowhere," he conceded. But the nation's bill for prescription drugs is forecast to reach $520 billion by 2013, more than twice its current level. At some point, something may crack. "We're on a path that is clearly not sustainable," Mr. Baker said. Then, perhaps, the current system could change or die. Until then, the United States can rely on Canada. From mpalmedo@cptech.org Mon Nov 15 16:58:03 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Mon Nov 15 16:58:03 2004 Subject: [Ip-health] Glassman op-ed on Ranbaxy De-Listing Message-ID: <41992389.6040403@cptech.org> http://www.aei.org/include/news_print.asp?newsID=21553 AIDS Policy in Shambles By James K. Glassman Scripps Howard News Service November 15, 2004 The strategy of fighting AIDS in Africa with questionable generic drugs made in developing countries now lies in shambles, as an Indian company withdrew its medicines last week because it can't guarantee they are potent enough. It's time now for the United Nations and its number-one financial angel, the United States, to reverse a policy that not only has failed to slow the AIDS epidemic but is almost certainly making people sicker. The use of unverified generics--which are copies of drugs developed and patented by research pharmaceutical companies in the United States and Europe--has been aggressively promoted by UN agencies like the World Health Organization and by nongovernmental organizations like Doctors Without Borders, based in Paris, and the Clinton Foundation, established by the former president. The WHO and NGOs have been claiming that generic companies in India, South Africa, Thailand and elsewhere can make sophisticated multi-dose combinations of AIDS drugs by cobbling together patented medicines. Instead, the generic makers are turning out to be the gang that can't copy straight. The ostensible reason for the WHO strategy is cost, but the research firms sell drugs in Africa at big discounts or give them away. A study by the Hudson Institute found that, on average, patented drugs cost less than generics in poor countries. The real reason for the strategy is vicious political animosity toward the United States and the research pharmaceutical companies. Such antagonism can kill. At the root of the current debacle is a simple question: Do people sick with AIDS in Kampala and Kinshasa deserve the same medicines as patients in Copenhagen and Chicago? Of course they do. But UN agencies and their NGO pals don't act that way. The WHO maintains a list of about 90 drugs that it "pre-qualifies" for relief agencies. But the list is maintained by a tiny staff with no facilities for testing, and the WHO does not warrant safety or effectiveness. Drugs on the list are now floating all over Africa. By contrast, American authorities have insisted on spending the $15 billion from President Bush's global AIDS program, the world's largest, only on drugs--generic or patented--that meet the standards of the U.S. Food and Drug Administration. The FDA even set up a fast-track process to speed approval of AIDS drugs made in developing countries. But, so far, there have been no takers--a fact that arouses suspicions about the generics. On Nov. 9, the Indian firm Ranbaxy, considered the best of the generic makers, withdrew all its AIDS drugs from the WHO list. That action followed WHO de-listings in spring and summer of five drugs made by Ranbaxy and another Indian company, Cipla. The moves vindicated U.S. policy, but the cost to sick Africans--and to the reputation of the WHO--is devastating. In addition, legal sources say NGOs that have been distributing the generics could face lawsuits from affected patients. No one knows how many people have been taking deficient medicines. There is no effective system to alert these patients or to get them on other therapies--the procedure in the U.S. and Europe. The WHO has taken a cavalier attitude toward recent blunders, stating that, while "in principle," patients should get off the de-listed drugs, they don't have to. And, incredibly, Daniel Berman of Doctors Without Borders told the Washington Post, "We are not worried about the safety of our patients. . . . We can't make an equation that if a drug is removed from the list, it's not a good drug." The danger extends beyond Africa. A poorly made copy of a patented drug may deliver a dose of medicine so weak that the virus could adapt to it through mutation and become resistant. These new viruses would require far more expensive drugs--or drugs that don't even exist today. Such strains could migrate to countries like the United States, where AIDS deaths have declined significantly, thanks to medicines developed in the late 1990s. Last summer, the respected American Foundation for AIDS Research sternly warned that a flood of untested generics, made by more than two dozen companies in developing nations, "could lead to widespread misuses and eventually to drug resistance, eradicating years of progress." That worry is fast becoming reality. At the very least, Congress should investigate the UN strategy and reconsider American funding. Stubborn advocates of the current policy must stop playing deadly political games with the world's health. James K. Glassman is a resident fellow at the American Enterprise Institute. From mpalmedo@cptech.org Mon Nov 15 17:04:03 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Mon Nov 15 17:04:03 2004 Subject: [Ip-health] SF Chronicle editorial on Ranbaxy De-Listing Message-ID: <4199264D.1020101@cptech.org> http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2004/11/15/EDGD99EORL1.DTL An AIDS setback San Francisco Chronicle November 15, 2004 IN FIGHTING AIDS, one of the few success stories is generic drugs that smother symptoms and extend life. It's not an overstatement to say these pills -- cheap copies of costlier originals -- hold the power to sustain countries where up to 1 in 5 people is infected. This crucial role may be in question, however. Rambaxy, India's biggest drugmaker and a leader in generics, has withdrawn seven AIDS-fighting drugs. The reason? It could not prove to United Nations regulators that the knockoff medicine was as effective as a first-line drug. The drugs may be retested and put back in circulation soon, but it adds a chilly note to the AIDS fight: a once-considered dependable tool doesn't always measure up. The negative results may also feed arguments that the United States' $15 billion AIDS funding should only be used to buy brand-name drugs, which can cost five to 10 times more than foreign-made generics. This position undercuts a generally worthy White House program to contain AIDS, which has infected 40 million worldwide. Generics are indispensable in this fight, especially in Africa where the toll is heaviest. Patients infected with the AIDS virus lose weight, suffer skin rashes and lose energy. With twice-a-day pills, the sick can show the "Lazarus effect" -- they are able to gain strength, weight and stamina enough to return to work and normal life. Take these pills away, and small countries such as Uganda, South Africa or Malawi with high AIDS rates will be plunged into deeper trouble. What is needed is a quicker test of international drug safety. The United Nations must inspect and certify the mainstay generics before they reach wide use. The United States should back a single international testing standard and drop its own rule-making, which serves major drugmakers better than AIDS patients. Generic drugs are a mainstay in treating AIDS. They must be made more safe and reliable. From B.Baker@neu.edu Tue Nov 16 09:51:02 2004 From: B.Baker@neu.edu (B.Baker@neu.edu) Date: Tue Nov 16 09:51:02 2004 Subject: [Ip-health] Glassman's faulty critique of the Ranbaxy de-listing and the Vioxx counter-example Message-ID: GLASSMAN'S FAULTY CRITIQUE ON THE RANBAXY DE-LISTING AND THE VIOXX COUNTER-EXAMPLE Professor Brook K. Baker, Health GAP November 15, 2004 Agents of deception and misinformation like James Glassman, posing as independent researchers at the American Enterprise Institute, are once again pursuing Big Pharma's beck and call and acting as "smokesmen" for U.S. AIDS czar, Randall Tobias. Glassman chortles over the Ranbaxy's voluntary delisting of its AIDS medicines at the WHO Pre-qualification Project and argues, without any proof whatsoever, that Indian generic drugs are now proven to be unsafe and that Doctors Without Borders, the WHO, and the Clinton Foundation should be sued for medical malpractice. Glassman argues that use of Indian generics "is almost certainly making people sicker." "Generic makers are turning out to be the gang that can't copy straight." "Antagonism [toward U.S. research pharmaceutical products] can kill." "No one knows how many people have been taking deficient medicines." "A poorly made copy of a patented drug may deliver a dose of medicine so weak that the virus could adapt to it through mutation and become resistant."* [*True in part, but erroneous in its implications concerning Ranbaxy's products.] Counter to Glassman's diatribe, the facts are relatively simple, but admittedly disturbing nonetheless. The WHO beginning in June and again in August discovered, through its own initiative and review of independent Contract Research Organizations, that proper record keeping standards and good clinical practice had not been followed by certain CROs used by Cipla and Ranbaxy to test the bioequivalence of their ARVs. Promptly, the WHO delisted the affected products and ordered the companies to submit new data. More recently, Ranbaxy voluntarily delisted its remaining ARVs because its independent review of CROs confirmed that proper procedures to establish bioequivalence had not been followed. These delisting decisions are based on poor record keeping practices and the absence of scientific verification of bioequivalence. However, the delisting did not prove that the medicines were unsafe or that they were not in fact bioequivalent. In fact, preexisting clinical evidence presented by MSF and multiple other researchers has established the clinical efficacy of the challenged products in resource poor settings: patient viral loads have declined, T-4 cell counts have risen, and patients' general well-being has increased. No one pretends that it wouldn't have been better if Cipla and Ranbaxy had crossed all their t's and if they had selected their independent research labs more carefully. However, both the WHO and the companies themselves have responded appropriately and promptly to the recently discovered discrepancies and they have not jumped to the unwarranted conclusion that the medicines are presumptively unsafe or inefficacious. It might be both fun and instructive to apply the structure of Glassman's "analysis" to the now infamous Vioxx market withdrawal. VIOXX COUNTER-EXAMPLE - PAIN RELIEF POLICY IN SHAMBLES "The strategy of fighting pain throughout the world with questionable brand name drugs produced in America now lies in shambles, as a major U.S. producer, Merck, withdrew its Vioxx medicine three weeks ago because it can't guarantee that Vioxx won't double or quadruple the risk of heart attack. It's now time for the United States and its number-one regulatory angel, the FDA, to reverse a policy that has not only failed to increase pain relief, but has only moderately reduced the risk of gastro-intestinal bleeding at the cost of greatly elevating the risk of heart disease. In sum, U.S./FDA policy is almost certainly making people sicker. The use of inadequately tested, researched-based medicines?which are original versions of drugs developed and patented by research pharmaceutical companies in the United State and Europe and then sold at astronomical prices around the world?has been aggressively promoted by U.S. agencies like the FDA and the Global AIDS Initiative and by NGOs like the American Enterprise Institute. The FDA and pro-PhRMA NGOs have been claiming that researched-based companies like Merck (and like Pfizer which recently had to blackbox its antidepressants with warnings about increased suicide risks for children) can make sophisticated drugs by cobbling together clinical trials designed to support exaggerated marketing claims. Instead, the major pharmaceutical companies have mainly succeeded in delaying investigation into the full range of dangerous adverse drugs effects?in essence treating drug consumers as guinea pigs in a cynical pursuit of profit. The essential reason for the U.S. strategy is profits?profits necessary to undertake research into the next generation of life-saving medicines. However, studies by Families USA, Public Citizen, and MSF have established that few PhRMA drugs are truly innovative, that drug companies neglect disease indigenous in the Global South, and that drug companies spend far less on research and development than on profits, executive salaries, and marketing. The real reason for the U.S. strategy is vicious political animosity toward generic drug companies located overseas and toward the NGOs and activists who promote greater access to affordable medicines for people living with HIV/AIDS and other pandemic diseases affecting poor people in developing countries. Such antagonism can and has killed millions of people priced out of the drug market by the unconscionable prices and protectionist policy adopted by major pharmaceutical companies and their proxies in the U.S. trade representative's office. The root of the current debate is a simple question: Do sick people in the U.S. and elsewhere need to buy more expensive, patented medicines that produce little or no therapeutic gain and that instead impose unexplored adverse effects just to affect Big Pharma's profits? Of course they don't. But the U.S./FDA and their NGO pals act as if they do. The WHO has set up a Pre-Qualification Project for AIDS drugs that employs internationally recognized standards for assessing bioequivalence and for testing good manufacturing practices at manufacturing sites. When those standards have not been met, WHO has not hesitated to refuse registration and in two recent instances has even delisted previously pre-qualified products when it double-checked record keeping at independent Contract Research Organizations. WHO oversight seems to have paid off more recently when a major India generic company, Ranbaxy, voluntarily delisted all of its AIDS medicines only weeks after undertaking its own independent review of work performed by its CROs. It would be nice to report that Merck and the FDA acted as promptly in response to early warning about the heart-related dangers of Vioxx. However, rather than acting within a matter of weeks like their counterparts in India and at the WHO, Merck and the FDA suppressed rumors and delayed studies designed to test the risk of adverse heart effects nearly 5 years after the first negative effects were reported. Even when a major study of heart problems was reported in 2001, Merck and the FDA still dragged their heels while annual sales rose to $2.5 billion/year, greatly padding Merck's profit margins in the meantime. No one knows how many people have been taking deficient, over-priced pain medicines, though the estimates in the U.S. alone are in the tens of millions. Earlier estimates are that nearly 27,000 people suffered unnecessary heartaches as a result of the unprincipled sale of a truly defective product. The danger extends beyond America. Vioxx has been sold worldwide. A poorly tested product delivers me-too pain-killing while it increases hypertension and clogs cardiac arteries. A pilot taking Vioxx could have a heart attack in the middle of a transatlantic flight killing hundreds of international tourists in the process. For years, well-respected organizations like the Consumer Project on Technology and Health GAP have argued that patents kill and Big Pharma's relentless drive for profits deforms therapeutic innovation and delays access for monopoly priced medicines. These defects occur not only with respect to AIDS medicines, but even for simple pain relief. Those warnings are quickly becoming reality. At the very least, Congress and international agencies should investigate the U.S. strategy and reconsider reliance on PhRMA's honesty and regulatory approval at its captive agency, the Food and Drug Administration. Stubborn advocates of the current policy, in the White House, in the PEPFAR program, and in the Department of Health and Human Services must stop playing deadly profit-driven game with the world's health." From mpalmedo@cptech.org Tue Nov 16 10:25:01 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Tue Nov 16 10:25:01 2004 Subject: [Ip-health] Xinhuanet news: Thai FTA not to hamper access to cheap anti-AIDS drugs Message-ID: <419A17BC.8060205@cptech.org> http://news.xinhuanet.com/english/2004-11/16/content_2224168.htm Thailand: FTA not to hamper access to cheap anti-AIDS drugs www.chinaview.cn 2004-11-16 13:18:40 BANGKOK, Nov. 16 (Xinhuanet) -- Thai negotiators involved in free trade agreement with the United States on Tuesday assured HIV/AIDS patients that Thailand will not allow the pact to hamper their future access to cheap anti-AIDS drugs. During an informal talk organized by the AIDS Access Foundationon Monday, AIDS activists and patients voiced their concerns that FTA could affect their access to low-cost anti-AIDS drugs. As the next round of talks scheduled for Dec. 13-17 is drawing near, worries have been grown over a push by the United States fora stricter protection of its intellectual property rights in Thai-US pact. The United States wants data on its drugs and other high-technology products being imported into Thailand to be protected for a longer period than allowed under World Trade Organization rules. It means Thailand may have to count on expensive imported anti-AIDS drugs longer than the global agreement requires. "Our position is clear, we will not sacrifice human health for trade benefits," Wiboonlasana Ruamraksa, deputy director-general of the Intellectual Property Department was quoted by Bangkok Postnewspaper as saying on Tuesday. She added Thailand would stick to the WTO framework as the basis for negotiations. Suchart Chongprasert, an official at the Food and Drug Administration and one of the negotiator, said the two countries had to find a balance between commercial interests and access to medicines in their talks. However, he insisted anything that affects access should not becompromised. Strongly opposing the five-year extension period on patent protection and strict control of data on medicines, Sureerat Treemarka, a member of the Thai Network of People Living with HIV/AIDS, said the monopoly of US drugs firms will force the poor undeveloping countries to suffer all the more. Meanwhile, women and girls have become the hardest-hit group since some 70,000 of the 570,000 AIDS patient in Thailand were aged between 15-24, of which 60 percent were women. Many young people engaged in unprotected pre-marital sex without fully understanding of the potential consequences of theiractions, said Health Minister Sudarat Keyuraphan. She added nine percent girls aged 15-19 admitted to having sexual relations, while eight percent aged below 20 were forced into their first sexual experience. Since the deadly HIV/AIDS virus was first detected in 1984, there are about 40 million people living with HIV/AIDS worldwide, half of whom are women aged 15-24. On this year's World AIDS day on Dec. 1 programs and activitiesunder the theme "Women, Girls and HIV/AIDS" will be held across the kingdom to draw more attention to women's AIDS problem. Enditem From mpalmedo@cptech.org Tue Nov 16 10:25:11 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Tue Nov 16 10:25:11 2004 Subject: [Ip-health] USTR Announces Intent to Negotiate FTAs with UAE and Oman Message-ID: <419A19F7.4080103@cptech.org> http://www.ustr.gov/Document_Library/Press_Releases/2004/November/U.S._Anno= unces_Intent_to_Negotiate_FTAs_with_UAE_Oman.html U.S. Announces Intent to Negotiate FTAs with UAE and Oman Contact: Richard Mills / Neena Moorjani (202) 395-3230 USTR Press Release 11/15/2004 WASHINGTON, DC =96 U.S. Trade Representative Robert B. Zoellick today announced the Administration=92s intent to negotiate Free Trade Agreements with the United Arab Emirates (UAE) and Oman, important steps on the path to fulfilling the President=92s vision of developing economic growth and democracy in the Middle East. Zoellick sent a letter today to Congressional leaders to notify of this intent to negotiate, in accordance with the procedures Congress established under the bipartisan Trade Act of 2002. Transmittal of the letter to the Hill followed shortly after Ambassador Zoellick=92s visit to the UAE and Oman and after House Ways and Means Committee Chairman Bill Thomas led a Congressional delegation to Oman and other countries in the Middle East. "A free trade agreement with the UAE and Oman will promote the President=92s initiative to advance economic reforms and openness in the Middle East and the Persian Gulf, moving us closer to the creation of a Middle East Free Trade Area," wrote Zoellick. "An FTA with the UAE and Oman will build on the FTAs that we already have with Israel, Jordan, and Morocco, as well as the FTA that we recently have signed with Bahrain. It will also encourage the six members of the Gulf Cooperation Council to adopt standards that promote trade and investment. Furthermore, our free trade agreements in the Middle East complement The 9/11 Commission Report recommendation urging the United States to expand trade with the Middle East as a way to =91encourage development, more open societies and opportunities for people to improve the lives of their families.=92" "These FTAs will directly benefit the United States," continued Zoellick. "By reducing and eliminating barriers to trade, a comprehensive FTA with the UAE and Oman will generate export opportunities for U.S. companies, farmers, and ranchers, help create jobs in the United States, and help American consumers save money while offering them more choices." The United States trade relationship with the UAE is the third largest in the Middle East, behind only Israel and Saudi Arabia. The U.S. has a combined trading relationship of $5.6 billion and a trade surplus of over $2 billion with these two countries. Major exports to these two countries include machinery, aircraft, vehicles and electrical machinery. Major imports include mineral fuel and woven apparel. Background In initial consultations with the Congress, including a meeting with the Congressional Oversight Group on September 8, 2004, broad bipartisan interest was expressed for an FTA with the UAE and Oman. Following these consultations, Zoellick visited the UAE and Oman in October to discuss with top officials the topics covered in the United States=92 comprehensive FTAs, to identify particular areas for work, and to assess the UAE=92s and Oman=92s commitment to moving forward with an FTA. The Office of the U.S. Trade Representative will work closely with the Congress over the next 90 days, as required by the Trade Act, and expects negotiations to commence in the beginning of 2005. Middle East Free Trade Initiative (MEFTA) In May 2003, the President proposed a plan of graduated steps for Middle Eastern nations to increase trade and investment with the United States and others in the world economy. The first step is to work closely with peaceful nations that want to become members of the World Trade Organization (WTO) in order to expedite their accession. As these countries implement domestic reform agendas, institute the rule of law, protect property rights (including intellectual property), and create a foundation for openness and economic growth, the United States will take a series of graduated steps with countries in the region tailored to their level of development. The U.S. will expand and deepen economic ties through comprehensive FTAs, Trade and Investment Framework Agreements (TIFAs), and Bilateral Investment Treaties (BITs), and will also enhance the Generalized System of Preferences (GSP) program for eligible countries. This Administration has concluded two FTAs, Morocco and Bahrain; ratified a third, with Jordan; and signed eight TIFAs with Middle East nations. United States Trade Agreements U.S. FTAs: These are reciprocal and ambitious agreements that open markets and strip away barriers across a broad array of goods, services, and agricultural products. TIFAs: The United States has TIFAs with a number of countries to enhance bilateral trade and coordinate regionally and multilaterally through regular senior-level discussions on trade and economic issues. The TIFAs create Joint Councils that consider a wide range of commercial issues and sets out basic principles underlying the nations' trade and investment relationship. BITs: These agreements level the playing field and ensure that U.S. investors are protected when they establish businesses in other countries. By safeguarding foreign subsidiaries of U.S. firms, BITs help promote new U.S. exports to the markets of BIT partners. BITs also protect the interests of average American investors, whose stock and bond portfolios often include stakes in foreign-invested firms. U.S. Trade Agenda The United States is working to open markets globally in the Doha WTO negotiations; regionally through the Asia Pacific Economic Cooperation (APEC) and the Free Trade Area (FTAA) of the Americas negotiations; and bilaterally, with FTAs. The Bush Administration has completed FTAs with 12 countries -- Jordan, Chile, Singapore, Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Australia, Morocco, and Bahrain. With this announcement, negotiations are under way or about to begin with 12 more countries: Panama, Colombia, Peru, Ecuador, Thailand, the five nations of the Southern African Customs Union (SACU), and now the UAE and Oman. New and pending FTA partners, taken together, would constitute America=92s third largest export market and the sixth largest economy in the world. U.S. =96 Middle East Free Trade Efforts (see chart) The 9/11 Commission Report The U.S. government has announced the goal of working toward a Middle East Free Trade Area, or MEFTA, by 2013. The United States has been seeking comprehensive free trade agreements (FTAs) with the Middle Eastern nations most firmly on the path to reform. The U.S.-Israeli FTA was enacted in 1985, and Congress implemented an FTA with Jordan in 2001. Both agreements have expanded trade and investment, thereby supporting domestic economic reform. In 2004, new FTAs were signed with Morocco and Bahrain, and are awaiting congressional approval. These models are drawing the interest of their neighbors. Muslim countries can become full participants in the rules-based global trading system, as the United States considers lowering the trade barriers with the poorest Arab nations. Recommendation: A comprehensive U.S. strategy to counter terrorism should include economic policies that encourage development, more open societies, and opportunities for people to improve the lives of their families and to enhance prospects for their children=92s future. From pedro_paranagua@yahoo.com.br Tue Nov 16 14:42:01 2004 From: pedro_paranagua@yahoo.com.br (=?ISO-8859-1?Q?Pedro_de_Paranagu=E1_Moniz?=) Date: Tue Nov 16 14:42:01 2004 Subject: [Ip-health] Seminar on Creativity and Human Society - Queen Mary, Uni of London Message-ID: <419A55A1.3070906@yahoo.com.br> Moderator: this may be of interest to people on the list, either Health's or Ecommerce's. Please authorise. Dear all, As I know it may be of your interest, please find bellow links for the above-mentioned seminar which will take place on the 29th and 30th of November, at Queen Mary, University of London. http://www.qmipri.org/esrc5_invitation.pdf (Invitation) http://www.qmipri.org/esrc5_prog.pdf (Programme) Fell free to inform anyone else. Kind regards, Pedro. Pedro de Paranagu=E1 Moniz LL.M. student at Queen Mary, University of London Researcher at the Brazilian Institute of International Trade Law and Development - IDCID www.idcid.org.br From Rachel.COHEN@newyork.msf.org Tue Nov 16 18:38:00 2004 From: Rachel.COHEN@newyork.msf.org (Rachel COHEN) Date: Tue Nov 16 18:38:00 2004 Subject: [Ip-health] MSF Press Release - R&D System Failing to Meet Health Needs of Developing Countries Message-ID: This is a multipart message in MIME format. -- [ Picked text/plain from multipart/alternative ] For Immediate Release RESEARCH AND DEVELOPMENT SYSTEM FAILING TO MEET HEALTH NEEDS OF DEVELOPING COUNTRIES Doctors Without Borders Challenges Ministerial Summit on Health Research to Ensure Development of New Medicines Geneva/Mexico City, November 16, 2004 ? The current system for health research and development is failing to bring the benefits of medical progress to the poor, according to the medical humanitarian organization Doctors Without Borders/Medecins Sans Frontieres (MSF) on the opening day of the Ministerial Summit on Health Research, ?Bridging the Know-Do Divide to Achieve the Millennium Development Goals,? in Mexico City. ?Today?s research and development (R&D) system fails the poor in two ways: new drugs that come onto the market are too expensive, and the health needs of people in developing countries are being ignored,? says Ellen ?t Hoen, policy advocacy director for MSF?s Campaign for Access to Essential Medicines. ?For this Summit to be a success, it needs to define policies to ensure the development of new and adapted medicines, diagnostics, and vaccines for neglected diseases.? Medicine research and development is almost exclusively confined to the private sector, driven by prospects for profitable returns rather than public health needs. As a result, only one percent of medicines developed in the last 25 years were for tropical diseases.* These diseases kill hundreds of thousands of people every year, mainly in the developing world. ?Our patients are sometimes more afraid of dying from the treatment than of dying from the disease,? said Virginia Morrison, an MSF nurse working in Angola. ?The national protocol for second-stage sleeping sickness in Angola is melarsoprol, a horrible 55-year-old drug which burns the veins and kills one in 20 patients. The only current alternative is eflornithine, which requires four infusions a day for 14 days and is not adapted to resource-poor settings. Even though there is a lot of basic research into the disease, the results are not being translated into new, effective, safe, and easy-to-use drugs and diagnostics.? Another example is Chagas disease, a parasitic disease that causes irreparable damage to internal organs and kills 50,000 people each year, mainly in poor rural communities in Latin America. ?Chagas patients are of no interest to pharmaceutical companies; many people die without ever being diagnosed. We desperately need new drugs to treat people with Chagas,? says Silvia Moriana, coordinator of MSF?s program in Bolivia. Global spending on health research has increased from $US30 billion in 1986 to $US105.9 billion today. Yet 90% of this money is still spent on the health problems of less than 10% of the world?s population.** ?Governments need to take responsibility for health R&D policy,? says Ellen ?t Hoen. ?We?ve heard promises, but we see no action.? ----------------- * Trouiller P, Olliaro P, Torreele E, Orbinski J, Laing R, Ford N. Drug development for neglected diseases: a deficient market and a public-health policy failure. Lancet 22 June 2002 359;9324: 2188-2194. ** Global Forum for Health Research, Monitoring financial flows for health research, November 2004. www.globalforumhealth.org More information and a full briefing document from MSF on this issue can be found at: http://www.accessmed-msf.org/ --- Rachel M. Cohen U.S. Director, Campaign for Access to Essential Medicines Doctors Without Borders/M=E9decins Sans Fronti=E8res (MSF) 333 Seventh Avenue, 2nd Floor * New York, NY * 10001-5004 * USA Tel: +1-212-655-3762 Mobile: +1-917-331-9077 Fax: +1-212-679-7016 E-mail: rachel.cohen@newyork.msf.org http://www.doctorswithoutborders.org/ http://www.accessmed-msf.org/ From gagnon@yorku.ca Wed Nov 17 09:48:01 2004 From: gagnon@yorku.ca (=?iso-8859-1?Q?Marc-Andr=E9_Gagnon?=) Date: Wed Nov 17 09:48:01 2004 Subject: [Ip-health] Patents hindering innovation Message-ID: <000c01c4cc1b$3c4d2ad0$2ad9fea9@yoursz6x6sefxo> This is a multi-part message in MIME format. -- [ Picked text/plain from multipart/alternative ] "The United States patent system has become sand rather than lubricant in t= he wheels of American progress", so say Jaffe & Lerner. http://www.economist.com/research/articlesBySubject/displayStory.cfm?subjec= tid=3D1198563&story_id=3D3388936 Intellectual property The cost of ideas Nov 11th 2004 >From The Economist print edition It is becoming ever more apparent that the patent system isn't working INTELLECTUAL property is the cornerstone of the modern knowledge economy. B= ut one of the main forms of intellectual property, the patent-a temporary m= onopoly designed to provide an incentive to innovate-is increasingly being = found wanting, even as the number of applications soars at patent offices a= round the world. America's patent system has "become sand rather than lubri= cant in the wheels of American progress", argue Adam Jaffe and Josh Lerner = in a new book, "Innovation and its Discontents: How our broken patent syste= m is endangering innovation and progress and what to do about it" (publishe= d by Princeton University Press). The world's patent system remains splinte= red along national lines, yet the system's defects are felt everywhere. "Patent offices are under incredible pressure," says Dominique Guellec, the= chief economist at the European Patent Office in Munich. Applications at m= any patent offices have doubled in the past ten years, and the average leng= th of each submission has increased by 50%. The average quantity of work re= quired to examine an application is three times greater than it was a decad= e ago. "Of course that can't be neutral in terms of quality," says Mr Guell= ec. In recent years, the scope of patents has broadened to encompass new techno= logies, as well as software, and in some instances business methods. Meanwh= ile, the legal power of patents, once awarded, has increased, and they are = more zealously sought. This, combined with an alleged decline in the qualit= y of patents-that is, how accurate their claims are and whether they are tr= uly novel or non-obvious-is deeply troubling, especially as, once awarded, = a patent is hard to revoke. Patently absurd In America, several controversial business-method patent awards, notably Am= azon's one-click payment process, have fuelled the perception that the Pate= nt and Trademark Office (PTO) is under strain. A study by M-CAM, an intelle= ctual-property consultancy, found that over 30% of patents make duplicate c= laims, raising questions about their validity. America's PTO dismisses the = criticism as anecdotal. "We're seeing lots of new industries being born, th= at is why there are a lot more patent applications," says Mary Critharis of= the PTO. The number of patent applications to the PTO is growing at around 6% a year= . The wait for a decision is on average 27 months-and much longer for compl= ex applications in advanced sciences. Last year, the PTO received around 35= 0,000 applications and currently has a backlog of over half a million to re= view. It is a global concern: foreigners account for around half of all pat= ents granted. Similar growth is occurring elsewhere, including in countries that previous= ly showed little interest in intellectual property. Applications to China's= patent office increased fivefold from 1991 to 2001. As countries such as C= hina, South Korea and India spend more on research and development, they ar= e filing more patents. The mission creep of America's patent system into more contentious areas is= also spreading elsewhere. Later this month, the European Council of Minist= ers will discuss draft legislation on harmonising policy on computer-implem= ented innovations. Many small software companies in Europe, as well as "ope= n-source" software developers that make non-proprietary software, oppose th= e initiative. They fear that it is a first step towards adopting controvers= ial software patents, already awarded in America, which could block differe= nt implementations of the same features. Were further proof needed that thi= s may not be an entirely positive development, look no further than the mig= hty software monopolist, Microsoft, whose chairman, Bill Gates, has called = on employees to increase the number of patents that the company files. The rising importance of patents has led both to an arms race and a game of= bluff. Many firms in the information-technology and life-sciences industri= es say they have an incentive to obtain as many patents as possible as barg= aining chips in litigation. The patents are used to reach a cross-licensing= agreement, usually with some cash thrown in, so that both firms can contin= ue to do business. Those firms that lack patents are thus disadvantaged. Countries increasingly complain to the World Trade Organisation and the Uni= ted Nations World Intellectual Property Organisation (WIPO) that the patent= system discriminates against them. Indeed, WIPO recently adopted a "develo= pment agenda" to consider different intellectual-property regimes appropria= te to the circumstances of a particular country or region. This was hailed = as a boon for reassessing patent protections on drugs and for open-source s= oftware. Poor countries have long complained that America is trying to expo= rt its tough intellectual-property protections. The growing debate about America's patents is focused on the process of exa= mining applications and the difficulty of challenging dubious patents. Pate= nt examiners typically know less about an invention than the applicant. Mor= eover, their workload is far higher for rejecting than granting an applicat= ion. This creates a perverse incentive for examiners to "dispose" of applic= ations by granting rather than rejecting them, argue Messrs Jaffe and Lerne= r in their new book. To resolve this, they call for a pre-grant notice peri= od when third parties can come forward with "prior art" that would invalida= te the patent. As for the second problem, legislation introduced into America's Congress l= ast month seeks to make patent-opposition trials easier for challengers by = eliminating some legal hurdles. The legislation would also curb the grantin= g of many forms of business-method patents. As these reforms are debated, the scale and central importance of the paten= t system are also coming under assault. "The innovation system is broken in= that there is too much emphasis on intellectual-property rights," says Suz= anne Scotchmer, the author of "Innovation and Incentives" (MIT Press), a bo= ok on the role of patents to be published soon. More than ever, she says, i= nventions that would otherwise go into the public domain because they are f= unded by taxpayers or charities become "cordoned off" by the patent system.= If so, perhaps the patent system not only needs to be repaired, but shrunk= ? --------------------------- Marc-Andr=E9 Gagnon York University, Political Science Courriel: gagnon@yorku.ca -- From joaninha@comcast.net Wed Nov 17 09:48:09 2004 From: joaninha@comcast.net (Joana Ramos) Date: Wed Nov 17 09:48:09 2004 Subject: [Ip-health] From the media: Novartis CEO: Europe Should Adopt Free-Market Drug Pricing Message-ID: <419AF8BD.6030601@comcast.net> So the real issue is an image problem of poor misunderstood Big Pharma? > Vasella acknowledged that the pharmaceutical industry is perceived as > "greedy and distant" and said it needs to respond to the challenges it > is facing and overhaul its negative image. > > "The public loves our products, they just don't love us," he said. Forwarded by -- Joana Ramos, MSW Cancer Resources & Advocacy 7303 23rd Ave. NE Seattle, WA 98115 206-229-2420 http://home.comcast.net/~farpost3/cancer/ http://news.morningstar.com/news/DJ/M10/D27/200410271151DOWJONESDJONLINE000984.html Novartis CEO: Europe Should Adopt Free-Market Drug Pricing (Copied as fair use) 10-27-04 11:51 AM EST BARCELONA -(Dow Jones)- The European Union should adopt a free-market approach to drug pricing, Daniel Vasella, chairman and chief executive of Swiss company Novartis AG (NVS), said Wednesday. Speaking to media at a conference organized by the International Federation of Pharmaceutical Manufacturers & Associations, Vasella said free-market pricing would be preferable to a single pricing policy or the current system, whereby prices are set by each individual government. The current system has led to imbalances in the prices of the same drugs across the European Union. This, in turn, has fueled the parallel trade of drugs, where a wholesaler buys cheaper drugs in one European country and resells them where they have a higher cost, pocketing the difference and bypassing the official distribution network of the original drug manufacturer. "We have a very artificial situation with free movement of goods but not free prices," Vasella said. Vasella, who earlier Wednesday was elected president of IFPMA for 2004-06, said the challenges the pharmaceutical industry is facing in the U.S. are the same in most other countries. The main trend the industry has acknowledged is that the age of the population is increasing, which leads to mounting healthcare costs for patients and the need to develop cures for diseases related to old age. "When you look at election rhetoric in the U.S., healthcare is one of the main topics," he said. Vasella said that a Republican government would look more favorably at the pharmaceutical and private insurance industries. At the same time a Democratic victory would favor reimportation of cheaper drugs from Canada and extension of prescription benefits, he said. "One would have a tradeoff between (reimportation) and broader coverage," Vasella said. Vasella also said that he's not concerned about the narrower view on drug safety U.S and European regulators are currently taking. "You need effective regulation," he said. "If a drug is withdrawn I don't worry because this means that you have a system that works," he said. Last month Merck & Co. Inc (MRK), the fourth largest pharmaceutical company in the world, said it would withdraw its blockbuster drug Vioxx, a painkiller and anti-inflammatory used by 70 million patients worldwide. "But let's remember that there are no drugs without side effects," he added. Vasella acknowledged that the pharmaceutical industry is perceived as "greedy and distant" and said it needs to respond to the challenges it is facing and overhaul its negative image. "The public loves our products, they just don't love us," he said. "We are viewed as protecting our drugs by selectively publishing clinical trials and aggressively marketing our products." To respond to such a negative perception, the industry should "work as a team" to highlight the positive contributions drug companies bring with their products, Vasella said. "We are being challenged and we have to respond. In future, we want to set agendas proactively," he added. Vasella highlighted four main themes the pharmaceutical industry should focus on. It will have to demonstrate that intellectual property is a precondition for new and better drugs, while improving perception at "grassroots level" among patients, who are the ultimate users of its products. Drug companies should also further partnerships with governments and non- governmental organizations to meet the needs of developing countries. At the same time, they will have to "show empathy," because "the majority of people say we are not doing enough," Vasella added. -By Elena Berton, Dow Jones Newswires; 44 207 842 9267; elena.berton@ dowjones.com Dow Jones Newswires 10-27-04 1151ET Copyright (C) 2004 Dow Jones & Company, Inc. All Rights Reserved. From mpalmedo@cptech.org Wed Nov 17 10:35:02 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Wed Nov 17 10:35:02 2004 Subject: [Ip-health] NYT: Drug Pricing Endangers US-Australia FTA Message-ID: <419B677F.4080807@cptech.org> http://www.iht.com/articles/2004/11/16/business/oz.html Drug pricing endangers U.S.-Australia pact The New York Times Elizabeth Becker and Robert Pear Wednesday, November 17, 2004 WASHINGTON Nine months ago, the United States and Australia completed negotiations on a landmark trade agreement that won unusually broad bipartisan support in the U.S. Congress. But a dispute over drugs, both prescription and generic, is threatening to delay the Jan. 1 effective date. Prime Minister John Howard of Australia, who sent troops to Iraq, has become one of President George W. Bush's strongest allies, and the trade agreement is meant to draw the countries even closer together. U.S. manufacturers of things from tractors to computers are eager for the agreement to take effect because it promises $2 billion a year in new industrial exports, which could create jobs for Americans. But it has been dogged by disputes over the ability of U.S. pharmaceutical companies to challenge decisions about which drugs will be covered, and at what prices, under Australia's national health insurance program. The pharmaceutical industry insists that the trade agreement should not go into effect until its concerns are addressed. In Australia, there has been a loud outcry that the pact could undermine the popular government program that makes prescription drugs available to all citizens at subsidized prices. In the United States, American drug companies have complained for years about their inability to understand or influence government decisions about coverage of drugs in Australia, where prices are among the lowest in the developed world, say officials of both countries. In August, when the Australian Parliament approved legislation to carry out the trade agreement, Howard, then running for re-election, accepted amendments that were demanded by the opposition Labor Party. Those amendments infuriated American pharmaceutical companies and helped force trade negotiators back to the table. Both countries say they are optimistic that they can find a solution, but the agreement will not take effect unless the United States accepts the Australian legislation or Australia agrees to change it. Frank Vargo, vice president of the National Association of Manufacturers, an American trade group, said: "It's unfortunate that the Australian Parliament chose to change the terms after the agreement was signed. We are urging all parties to be as flexible as possible and to move as quickly as possible to resolve these issues." A senior trade official said that Washington had raised concerns with Australia about how its legislation affects American drug products. "We are not happy with it," said the official, who asked for anonymity because negotiations over the Australian legislation are continuing. The United States, she said, is concerned about copyright issues as well, but feels "very confident we can work this out." Mark Grayson, a spokesman for the Pharmaceutical Research and Manufacturers of America, which represents brand-name drug companies, said the Australian legislation made it more difficult for the companies to enforce their patent rights. Under Australian law, drug companies face fines of up to $7.6 million if they make spurious or "vexatious" patent claims to delay the entry of cheaper generic drugs to the Australian market. A brand-name drug maker can ask an Australian court to block the marketing of a drug that infringes on its patents. But before doing so, the manufacturer must certify that the proceedings were "commenced in good faith and have reasonable prospects of success." If the court finds no reasonable basis for the litigation, it can fine the brand-name drug maker. Drug makers are not alone in criticizing the pact. Other critics of the trade agreement, like Peter Drahos, a law professor at the Australian National University, said the pact would undermine the government program that provides medicine to Australians. "The large pharmaceutical industry has had the program in its sights for a long time," Drahos said. For Drahos, the agreement poses a fundamental question: Can trade agreements trump the domestic laws that underpin a nation's social contract? Mark Vaile, the Australian trade minister, discounted those concerns. "There is nothing in the free trade agreement that would increase drug prices in Australia or change the way the pharmaceutical benefits scheme operates," he said. Americans have long protested that they often have to pay more for brand-name prescription drugs than people in other industrialized countries. Rather than reducing prices in the United States, some pharmaceutical companies are trying to raise the prices they charge abroad, saying that American consumers bear too much of the cost of research to create medicines. Such action has not gone unnoticed in Washington. Representative Tom Allen, Democrat of Maine, said he worried that the pharmaceutical industry had "undue influence over trade negotiations" and was trying to weaken other governments' ability to hold down drug prices. "The risk is that the brand-name pharmaceutical industry will be able to write international trade rules that overrule domestic law," Allen said. Drug companies contend, though, that the law is inconsistent with Australia's obligations under international trade agreements. Eric Noehrenberg, a trade specialist at the International Federation of Pharmaceutical Manufacturers Associations, based in Geneva, said the Australian legislation would reduce the incentives for patent owners to introduce new drugs in Australia. As a result, he said, Australian patients will have less access to new and improved treatments. Noehrenberg and Grayson, the spokesman for the American pharmaceutical group, allege that the Australian law discriminates against the drug industry, in violation of international trade agreements. The Bush administration appears to agree. Richard Mills, the spokesman for the U.S. trade representative, said that the Australian legislation had to conform with international agreements protecting intellectual property, like patents, before the trade agreement could take effect. But Dr. Ken Harvey, a senior lecturer on public health at La Trobe University in Melbourne, said that drug companies were complaining too loudly. The trade agreement, he said, already gives American drug companies new leverage in the Australian market, and it could ultimately lead to "higher drug prices and less generic competition." From mpalmedo@cptech.org Wed Nov 17 10:35:15 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Wed Nov 17 10:35:15 2004 Subject: [Ip-health] Drug firms let down Africa over Aids, says GSK head Message-ID: <419B6DF5.1020309@cptech.org> http://business.timesonline.co.uk/article/0,,8209-1359216,00.html November 15, 2004 Drug firms let down Africa over Aids, says GSK head The Times Jon Ashworth THE chief executive of GlaxoSmithKline, J-P Garnier, has admitted that the pharmaceuticals industry has been too slow to address its negative image and should have acted faster to combat the Aids epidemic. In an interview with The Times, the French-born executive said GSK and its competitors should have taken the initiative to supply cheap Aids drugs to Africa. GSK, the world=92s leading producer of antiretroviral drugs, has reduced the price of its Aids treatments in the developing world, and licensed production of cheap generic drugs. But it faces criticism that the treatments are either unavailable or too expensive. Dr Garnier defended GSK=92s policy on Aids treatment, but said the company should have acted sooner. He said: =93We always end up doing the right things, but sometimes we do it too late. Not many industries are selling their goods to Africa at cost. But we get criticised because we do it after people have been banging on our door for a long time. =93We should have done it way before anybody knew there was a problem in Africa. We, I, didn=92t have the vision of saying, =91we must act now=92.= =94 GSK has also faced criticism over access to clinical data on drugs. In August, the company paid =A31.4 million to settle a lawsuit brought by Eliot Spitzer, the New York attorney-general. He accused the company of withholding clinical trial data showing Seroxat, its antidepressant, was harmful to children. GSK now makes data on drug trials available on the internet. Dr Garnier said the industry had been dominated for too long by =93techies in white coats=94. =93They didn=92t understand that you still need to deal with the public at large. They have rights. They need to be reassured. I think we took a long time to understand it and now we=92re paying the price.=94 Dr Garnier retires in three years, and admitted he was stung by criticism of his proposed =A315 million severance package, voted down by shareholders in 2003. From Sean.HEALY@geneva.msf.org Wed Nov 17 11:08:01 2004 From: Sean.HEALY@geneva.msf.org (Sean.HEALY@geneva.msf.org) Date: Wed Nov 17 11:08:01 2004 Subject: [Ip-health] Mexico Summit on Health Research -- press coverage Message-ID: Tuesday, November 16, 2004 ? Last updated 10:36 p.m. PT Officials talk diseases at health summit By MARK STEVENSON ASSOCIATED PRESS WRITER MEXICO CITY -- International experts kicked off the first worldwide health research summit Tuesday in a desperate bid to focus attention on the so-called forgotten diseases - illnesses of the poor that account for half the world's deaths. While there has been innovation in treating lifestyle diseases of the rich, like obesity and cardiovascular problems, the five-day World Health Organization's Summit on Health Research was tackling the lack of funding and drug development for tropical and infectious diseases, most curable even though they kill about 15 million people per year. At the center of the agenda for researchers from 76 countries are things like "the 10-90 gap": the fact that only 10 percent of the world's health research budget goes to combat the most severe problems for 90 percent of the population. "The system has been very successful at developing drugs, diagnostics and vaccines, but much less successful at getting them to people who need them," said Tim Evans, the WHO's assistant director-general, said at the opening ceremony of the summit. Evans estimated that two-thirds of current child deaths could be prevented with existing technology. He called for "a research agenda that is not dependent on the private sector," noting that drug companies don't have much incentive to distribute mosquito nets that could protect African children from malaria. Dr. Bernard Pecoul of Medecins San Frontiers said rich nations and drug companies should not only help make existing medications more accessible, but also develop new medications for the diseases of the poor. "I'm not criticizing the private sector. They're just not in a very good position to set priorities," Pecoul said, noting there is more money dedicated to developing new anti-cholesterol pills than selling anti-malarial drugs. "The corporations should open up their laboratories and libraries. It won't earn them any money, but it will improve their image," said Pecoul. His group, also known as Doctors without Borders, says there is a precedent for such massive, government-directed research efforts, noting that half the cost of developing anti-HIV drugs came from public coffers, not private companies. But, as the Medecins statement noted, "if HIV/AIDS had hit poor countries only, patients would probably still be waiting for the first anti-retroviral to be developed." There is a trend of the world seemingly losing interest in deadly diseases still common in the third world, but eradicated in developed countries. Health workers treating tuberculosis said they still rely on a diagnostic test developed in 1882. A nurse treating the deadly tsetse fly-borne disease known as sleeping sickness said doctors in Africa still rely on an arsenic-based drug in use since 1949 that burns patient's veins and kills one in twenty of them. That, despite the fact that world health research funding has risen to $106 billion annually. "There is still a massive gap in funding for health problems that affect low- and middle-income countries," Evans said. For example, of about 1 million health research papers listed on scientific data bases, 42 percent are U.S. or Canadian, 47 percent from Europe or other developed nations, and only 11 percent of such studies are done in the less-developed world. Crises like the SARS virus or avian flu provide an example of quick coordination between developed and developing nations, and massive research and investment in a short time. But while SARS did serve as a model for sharing health information with developing nations in Southeast Asia, it also received attention mainly because it quickly spread to developed nations like Canada - something tuberculosis or malaria won't do. NGO: Poor don't benefit from research Most drug research goes to finding cures to the ailments found in developed nations, says M=E9dicins Sans Fronti=E8res. BY MICHAEL O?BOYLE/The Herald Mexico November 17, 2004 The current system for health research is failing to bring benefits to the world's poor, said representatives from the medical humanitarian organization M=E9dicins Sans Fronti=E8res on Tuesday. "Today's research and development system fails the poor in two ways: new drugs that come onto the market are too expensive and the health needs of people in developing countries are being ignored," said Ellen 't Hoen, a MSF campaigner, at a press conference on the opening day of a World Health Organization summit being held in Mexico City this week. While the summit will focus on improving the research of health care systems how to apply existing medicines and technologies in the most cost effective ways 't Hoen said developed nations cannot ignore their responsibility to fund drug research for the world's "neglected diseases." Most drug research is focused on finding cures to the ailments common in the lucrative markets of the United States and Europe. Meanwhile, diseases such as malaria that afflict only poor populations have been mostly ignored by drug companies. Of the nearly 1,400 new drugs developed between 1975 and 1999, only 16 were for tropical diseases and tuberculosis, conditions that account for more than 10 percent of global illnesses, according to MSF. As a consequence of the lack of new research, the treatment of neglected diseases relies on old, often highly toxic, medicines. Despite a global increase in cases of TB, diagnosis of the disease still relies on methods dating from 1882 while treatment depends on drugs developed 40 to 60 years ago. Virginia Morrison, an MSF nurse working in Angola, said health workers in the field see every day the suffering caused by the lack of new drugs. Morrison said she only had two drugs to work with in treating severe infections of sleeping sickness, which afflicts an estimated 500,000 people a year and kills 60,000. One of the drugs "is a horrible 55-year-old drug which burns the veins and kills one in 20 patients" and the other is ill-adapted for field conditions in Africa, Morrison said. "Our patients are sometimes more afraid of dying from the treatment than of dying from the disease," she said. "Having only these options is unacceptable medical practice." "Even though there is a lot of basic research into the disease, the results are not being translated into new, effective, safe and easy-to-use drugs." Dr. Bernard Pecoul, head of the Drugs for Neglected Diseases initiative (DNDi) criticized both the United States and the European Commission for failing to fund research for the diseases that don't interest pharmaceutical companies. "There needs to be a shift in political agendas," Pecoul said. More than 40 percent of the world's total spending on health research is provided by the public sector, mostly from the United States and Europe, according to a report by the Global Forum for Health Research that is hosting a parallel conference to the ministers summit. But 't Hoen said public research has become "contaminated by market driven logic," noting that public funds are used mostly to research the same diseases that interest the private sector. She said new schemes had to be developed to redirect public research funds toward neglected diseases. "The WHO needs to take the leadership on this, you can't just keep setting goals without saying how you are going to achieve them," said 't Hoen. "We need to look setting up a radically different system to set priorities." World Health Leaders Call for New Research Goals Tue 16 November, 2004 22:30 By Lorraine Orlandi MEXICO CITY (Reuters) - Global health leaders meeting in Mexico this week want nations of the world to spend more on medical research, not only to develop new cures but to make those now on the market available to the poor. Existing tools as simple as mosquito nets can cut deep into massive health problems such as malaria in developing nations, but research is needed to find ways to best use them, organizers of a summit for health research said at the start of the four-day event in Mexico City on Tuesday. "The outlook is bleak (without such research) in terms of reaching health gains that we know are possible," Dr. Tim Evans, assistant director-general of the World Health Organization, told a news conference. Health ministers from 70 countries, joined by scientists, international leaders and private industry, will reiterate a call for governments to dedicate 2 percent of their health budgets to medical research, according to a draft of a declaration expected to be issued later in the week. Funding for medical research is rising, and the number of public-private partnerships to develop new drugs has increased dramatically, providing promise for future treatments. Yet, hundreds of thousands of women die every year in pregnancy, most of them in developing nations, from conditions that are often easily treatable or preventable. HALF OF DEATHS EASILY PREVENTABLE While such long-standing problems persist, poor populations are also ravaged by newer diseases like AIDS and new pandemic infections emerge at a rate of about one a year. In a report this month the World Health Organization said more effective research could prevent half the world's deaths with simple and cost-effective methods. For example, mosquito nets could dramatically reduce children's deaths from malaria in some African nations, but a small minority of children now have then, Evans said. Local authorities need programs to deliver them universally. One district in Tanzania reduced child mortality by 40 percent simply by making a local study of health problems and reallocating its health budget of about $2 per person accordingly, he said. The independent humanitarian medical aid agency Medecins Sans Frontieres, or MSF, said on Tuesday that despite brave talk, health leaders need to take more drastic steps to focus medical research on people suffering from "neglected diseases" in poor countries. "The current system is failing people in developing countries in a number of ways," said Ellen Hoen, who runs the MSF campaign for access to essential medicines. MSF experts singled out diseases including malaria, tuberculosis, AIDS and sleeping sickness that are not being adequately treated in developing countries. In the case of sleeping sickness, a disease that causes madness and then death and which is prevalent in Africa and carried by the tsetse fly, treatments being used are half a century old. "The national protocol for second-stage sleeping sickness in Angola is melarsoprol, a horrible 55-year-old drug which burns the veins and kills one in 20 patients," said Virginia Morrison, an MSF nurse working in Angola. **************************************** Sean Healy Information Officer Campaign for Access to Essential Medicines M=E9decins Sans Fronti=E8res Geneva, Switzerland tel ++41-22-8498 401 fax ++41-22-8498 404 mobile tel ++41-79-239 9271 sean.healy@geneva.msf.org www.accessmed-msf.org From zackie@pixie.co.za Wed Nov 17 19:24:01 2004 From: zackie@pixie.co.za (Zackie Achmat) Date: Wed Nov 17 19:24:01 2004 Subject: [Ip-health] ALP - TAC Letter to MSD -- Efavirenz Message-ID: This is a multi-part message in MIME format. -- [ Picked text/plain from multipart/alternative ] Dear All Below is a self-explanatory letter regarding potential efavirenz stock-outs in South Africa. There are two culprits in this problem =96 First, now mor= e than a year after our Cabinet has approved an operational plan for ARV treatment, the tender for ARVs have not yet been awarded =96 there is no contract between the national department and MSD and second, equally important, MSD should have issued at least four licences to generic producers to ensure sustainability. Regrettably, apologists for the Bush Administration, PEPFAR and the FDA wil= l deliberately undermine WHO pre-qualification process, the DOHA declaration that ensures generic production while ignoring their own silence or complicity in relation to MSD=92s role in the VIOXX scandals. Thanx Zackie Letter from the AIDS Law Project on behalf of the TAC to MSD calling for more generic licenses for Efavirenz 15 November 2004 Mr Chirfi Guindo CEO: MSD (Pty) Ltd Private Bag 3 Halfway House 1685 SOUTH AFRICA Per fax: (011) 655-3187 Dear Mr Guindo ENSURING A SUSTAINABLE SUPPLY OF AFFORDABLE ANTIRETROVIRAL MEDICINES 1.=09We act on behalf of the Treatment Action Campaign (=93the TAC=94). 2.=09We refer to previous correspondence between the TAC and the AIDS Law Project (=93the ALP=94) on the one hand and MSD (Pty) Ltd (=93MSD=94) on th= e other. Much of this correspondence, which dates back to 14 May 2002 and deals with access to MSD=92s essential antiretroviral (ARV) medicines efavirenz and indinavir (marketed in South Africa as Stocrin=AE and Crixivan=AE respectiv= ely), is referred to in a letter from our offices dated 13 February 2004. A copy of that letter is attached hereto marked =93A=94. Copies of the corresponde= nce between our offices since that date are attached hereto marked =93B=94, =93= C=94, =93D=94 and =93E=94 respectively. 3.=09It has come to our client=92s attention that MSD is currently unable t= o satisfy public sector demand for efavirenz. As you know, efavirenz is one o= f the key ARV drugs used in the treatment of HIV infection and is used by public sector health facilities as part of the first-line ARV treatment regimen. While we acknowledge that many patients can be and in fact are placed on nevirapine-based regimens that exclude the use of efavirenz, we nevertheless recognise that in many cases =96 such as concomitant treatment for tuberculosis, certain liver conditions and alcohol dependence =96 the u= se of nevirapine may lead to serious life-threatening adverse events. In such cases, access to efavirenz is essential. 4.=09According to information that we have received, MSD has been unable to deliver sufficient stocks of efavirenz to satisfy the October and November 2004 orders placed by the Gauteng Central Medicines Depot in Auckland Park. As a direct result, Chris Hani Baragwanath Hospital has only received partial delivery of its orders. As recently as 8 November 2004, MSD was onl= y able to deliver 300 bottles of 600mg efavirenz capsules, which we have been advised amounts to about 35% of a month=92s supply at the hospital=92s curr= ent dispensing rate and significantly less stock than is outstanding on previou= s and current orders. 5.=09This has resulted in extreme caution in the initiation of treatment fo= r new patients. With growing public demand for treatment and lengthy waiting queues, this is something that the public sector can ill afford. It places the lives of many people living with HIV/AIDS at risk. 6.=09This is not the first time that stock shortages of efavirenz have been brought to the ALP=92s and TAC=92s attention. Our client and we were advise= d in January of this year that a shortage of efavirenz 50mg (used in the treatment of HIV infection in children over the age of three years) resulte= d in at least one patient defaulting on treatment for four days. 7.=09At the time, the TAC brought to your attention the serious consequence= s of patients defaulting on their treatment. In particular, our client drew attention to the potential for the development of resistance, most notably in the case of a non-nucleoside reverse transcriptase inhibitor such as efavirenz where resistance is not only limited to the particular drug in question but all other drugs in the same class, such as nevirapine. 8.=09In his letter dated 19 January 2004, a copy of which is attached heret= o marked =93F=94, the chairperson of the TAC explained how this =93has the po= tential to limit severely the future treatment options of children currently using an efavirenz-based regimen=94, recognising that =93the treatment options of children, relative to those of adults with HIV-infection, are already somewhat limited.=94 9.=09In the same letter, Mr Zackie Achmat explained as follows: =93This unacceptable situation points to the need for multiple suppliers of essential medicines. With more providers there will be less likelihood of all companies running out of stock. Competition will also ensure that companies are more careful about monitoring their stock.=94 10.=09It has been our client=92s view for some time that the most effective= and efficient way to ensure a sustainable supply of affordable efavirenz is for MSD to grant multiple non-exclusive voluntary licences on reasonable terms to importers and manufacturers of generic efavirenz products. 11.=09In fact, our client has consistently called for your company to publi= cly commit to the grant of such licences. Instead, MSD has indicated in a lette= r to our offices that it =93is open to evaluating further bona fide applicati= ons [for voluntary licences], provided that they meet the required standards fo= r quality and sustainability.=94 A copy of that letter, already referred to above as =93C=94, is attached hereto. 12.=09We record that to date, however, MSD has: (a) Granted a single =93non-exclusive patent license for the manufacture an= d sale of a generic version of Efavirenz to Thembalami Pharmaceuticals (Pty) Ltd. (=93Thembalami=94), the joint venture partner of Adcock Ingram, for So= uth Africa and other countries in the Southern African Development Community (SADC)=94; (b) Has expressly informed at least one generic manufacturer that it has no intention whatsoever of licensing anyone else at this point because =93[i]n view of the forecast numbers =85 received from the ministry of health in regard to treatment of patients in the provinces, =85 [MSD does] not believ= e that more than two suppliers of Stocrin and Crixivan are reasonable=94; and (c) Has informed the generic manufacturer referred to in paragraph 12.b above of its intention =93to reconsider multiple suppliers as the patient numbers increase and warrant more capacity in supply of these drugs.=94 13.=09However, not only has Thembalami failed to bring any efavirenz produc= ts to market, but also all its ARV products have been recalled from the market by parent company Ranbaxy (SA) (Pty) Ltd. In addition, Ranbaxy Laboratories Limited India has voluntarily withdrawn all its ARV products from the World Health Organization (WHO) list of pre-qualified medicines. As you know, WHO pre-qualification means that the product has been found to be acceptable, i= n principle, for procurement by United Nations agencies. 14.=09We once again submit that MSD=92s failure to meet the demand for a life-saving medicine constitutes the abuse of rights in a patent, being a well-recognised ground for the granting of compulsory licences under sectio= n 56 of the Patents Act, 57 of 1978. In addition, the same conduct constitute= s abuse of market dominance, as contemplated in section 8 of the Competition Act, 89 of 1998, as does MSD=92s refusal to license additional generic drug manufacturers. 15.=09In our previous correspondence dated 13 February 2004 (already referr= ed to above and attached hereto marked =93A=94), we once again drew attention = to the 9 December 2003 agreements entered into between the complainants (Hazel Tau and others) and GlaxoSmithKline and Boehringer Ingelheim respectively a= s the basis for the settlement of the excessive pricing complaint lodged before the Competition Commission in September 2002 (case no. 2002Sep226). In terms of these settlement agreements, the two groups of pharmaceutical companies agreed to licence four and three generic pharmaceutical companies respectively to manufacture and/or import generic zidovudine, lamivudine an= d nevirapine products. 16.=09We call on MSD to commit to doing the same, or alternatively, to foll= ow the example of Bristol-Myers Squibb and stop enforcing its exclusive rights in ARV medicine patents in sub-Saharan Africa. We trust that you will satisfactorily respond to this letter by no later than Friday, 26 November 2004. Yours sincerely Jonathan Berger Head: Law & Treatment Access Unit cc: Dr N Xundu: Director, HIV/AIDS/STI/TB (HAST) Directorate, Gauteng Department of Health ((011) 355-3297) Dr GM Ramokgopa: MEC for Health, Gauteng ((011) 838-4143) Dr H Zokufa: Manager, Pharmaceutical Policy and Planning, National Department of Health ((012) 321-3103) Mr MBM Mpahlwa: Minister of Trade and Industry ((012) 394-0337) Dr ME Tshabalala-Msimang: Minister of Health ((012) 325-5526) [END OF LETTER TO MSD] -- From selgelid@med.usyd.edu.au Thu Nov 18 12:51:12 2004 From: selgelid@med.usyd.edu.au (Michael J Selgelid) Date: Thu Nov 18 12:51:12 2004 Subject: [Ip-health] call for papers--Ethics/Infectious Disease Message-ID: <419C1AF2.5020901@med.usyd.edu.au> This is a multi-part message in MIME format. -- [ Picked text/plain from multipart/alternative ] Hello there, I'm resending (see below) the call for papers for our special edition of BIOETHICS on Ethical Issues in Infectious Disease as a reminder. Please feel free to distribute to others that might be interested. Please note that the deadline for submission has been extended until 15 January 2005. Thanks and best wishes, Michael -- Michael J. Selgelid, Ph.D. Sesqui Lecturer in Bioethics email: selgelid@med.usyd.edu.au or MichaelS@science.usyd.edu.au mobile phone: +61 (0)431 124 286 Centre for Values, Ethics and the Law in Medicine Blackburn Building D06 The University of Sydney NSW 2006 Australia office phone: +61 (0)2 9036 5324 fax: +61 (0)2 9351 4887 and Unit for History and Philosophy of Science Carslaw Building F07 The University of Sydney NSW 2006 Australia office phone: +61 (0)2 9351 7652 fax: +61 (0)2 9351 4124 My HPS homepage: http://www.usyd.edu.au/hps/staff/michael.html -- Bioethics Special Issue on Ethical Issues in Infectious Disease CALL FOR PAPERS Bioethics announces a special issue on 'Ethical Issues in Infectious Disease' in 2005, to be guest edited by Margaret P. Battin and Michael J. Selgelid. We invite submissions on all aspects of this general topic. Issues of particular interest include, but are not limited to: =B7 Drug distribution and resistance =B7 Social, political, and economic causes and consequences of infectious disease =B7 "The duty to treat" =B7 Distribution of medical--and bioethics--research resources =B7 History of ethical analysis of infectious disease control =B7 Panic, prejudice, and perceptions of pestilence =B7 Public health policy matters, such as: - Travel restrictions - Isolation/quarantine - Notification/reportability - Compulsory vaccination/testing/treatment - Protection of individuals vs. society - Bioterrorism preparedness - Globalization and the health care situation in developing countries Submissions should use endnotes conforming to the Bioethics style as given on the web page www.blackwellpublishers.co.uk/journals/bioethics . We discourage papers of more than 5,000 words. Upon submission authors should include full contact details (especially e-mail address), a brief abstract (250 words), and a few lines of biographical information, all in a single electronic file. Submission deadline: 15 January 2005; by email (preferably) to the managing editor at biomanag@health.wits.ac.za . Authors should also send ONE hard copy (by airmail), also to arrive by 1 January, to Romi Fuller, Managing Editor Bioethics, Faculty of Health Sciences, University of Witwatersrand, 7 York Road, Parktown, Johannesburg 2193, South Africa. Tel +27 11 717 2719, Fax +27 11 643 1264. If an email submission is not possible, authors should include a disk with the hard copy sent by email. We welcome early discussion of brief proposals/abstracts (maximum 250 words) by email to both: battin@utah.edu AND selgelid@med.usyd.edu.au ; please indicate "INFDISEASE--BIOETHICS" in the subject line. -- From jwkckid1@ix.netcom.com Thu Nov 18 12:52:53 2004 From: jwkckid1@ix.netcom.com (Jeff Williams) Date: Thu Nov 18 12:52:53 2004 Subject: [Ip-health] Mexico Summit on Health Research -- press coverage References: Message-ID: <419C6D72.DF6B6DE3@ix.netcom.com> Sean and all, Marks piece here is very good and does point out some glaring and well known problems. However this piece is typical of a "Report" and as such offers very few suggestions as to real solutions. This "Report" of Marks also leaves out much of the problem as well. NGO's in particular are very good in some cases at coming up with proposed solutions and researching recognized problems. But they are not so good at implimenting/effecting those proposed solutions, only telling other commercial and government organizations what they "Should" do as part of their proposed solutions. The WHO is a beast of a different stripe. It could, and should seek to not only develop proposed solutions, and identify problems, but also effect/impliment them. However over the history of the WHO they have yet to accept that challenge. Hence not unlike many NGO's the WHO is a like the UN that spawned it, much about debate, discussion, and formulating ideas, and nothing about getting the job done in any effective manner. Sean.HEALY@geneva.msf.org wrote: > Tuesday, November 16, 2004 ? Last updated 10:36 p.m. PT > > Officials talk diseases at health summit > > By MARK STEVENSON > > ASSOCIATED PRESS WRITER > > MEXICO CITY -- International experts kicked off the first worldwide healt= h > research summit Tuesday in a desperate bid to focus attention on the > so-called forgotten diseases - illnesses of the poor that account for hal= f > the world's deaths. > > While there has been innovation in treating lifestyle diseases of the ric= h, > like obesity and cardiovascular problems, the five-day World Health > Organization's Summit on Health Research was tackling the lack of funding > and drug development for tropical and infectious diseases, most curable > even though they kill about 15 million people per year. > > At the center of the agenda for researchers from 76 countries are things > like "the 10-90 gap": the fact that only 10 percent of the world's health > research budget goes to combat the most severe problems for 90 percent of > the population. > > "The system has been very successful at developing drugs, diagnostics and > vaccines, but much less successful at getting them to people who need > them," said Tim Evans, the WHO's assistant director-general, said at the > opening ceremony of the summit. Evans estimated that two-thirds of curren= t > child deaths could be prevented with existing technology. > > He called for "a research agenda that is not dependent on the private > sector," noting that drug companies don't have much incentive to distribu= te > mosquito nets that could protect African children from malaria. > > Dr. Bernard Pecoul of Medecins San Frontiers said rich nations and drug > companies should not only help make existing medications more accessible, > but also develop new medications for the diseases of the poor. > > "I'm not criticizing the private sector. They're just not in a very good > position to set priorities," Pecoul said, noting there is more money > dedicated to developing new anti-cholesterol pills than selling > anti-malarial drugs. > > "The corporations should open up their laboratories and libraries. It won= 't > earn them any money, but it will improve their image," said Pecoul. His > group, also known as Doctors without Borders, says there is a precedent f= or > such massive, government-directed research efforts, noting that half the > cost of developing anti-HIV drugs came from public coffers, not private > companies. > > But, as the Medecins statement noted, "if HIV/AIDS had hit poor countries > only, patients would probably still be waiting for the first > anti-retroviral to be developed." > > There is a trend of the world seemingly losing interest in deadly disease= s > still common in the third world, but eradicated in developed countries. > Health workers treating tuberculosis said they still rely on a diagnostic > test developed in 1882. > > A nurse treating the deadly tsetse fly-borne disease known as sleeping > sickness said doctors in Africa still rely on an arsenic-based drug in us= e > since 1949 that burns patient's veins and kills one in twenty of them. > > That, despite the fact that world health research funding has risen to $1= 06 > billion annually. > > "There is still a massive gap in funding for health problems that affect > low- and middle-income countries," Evans said. For example, of about 1 > million health research papers listed on scientific data bases, 42 percen= t > are U.S. or Canadian, 47 percent from Europe or other developed nations, > and only 11 percent of such studies are done in the less-developed world. > > Crises like the SARS virus or avian flu provide an example of quick > coordination between developed and developing nations, and massive resear= ch > and investment in a short time. > > But while SARS did serve as a model for sharing health information with > developing nations in Southeast Asia, it also received attention mainly > because it quickly spread to developed nations like Canada - something > tuberculosis or malaria won't do. > > NGO: Poor don't benefit from research > > Most drug research goes to finding cures to the ailments found in develop= ed > nations, says M=E9dicins Sans Fronti=E8res. > > BY MICHAEL O?BOYLE/The Herald Mexico > > November 17, 2004 > > The current system for health research is failing to bring benefits to th= e > world's poor, said representatives from the medical humanitarian > organization M=E9dicins Sans Fronti=E8res on Tuesday. > > "Today's research and development system fails the poor in two ways: new > drugs that come onto the market are too expensive and the health needs of > people in developing countries are being ignored," said Ellen 't Hoen, a > MSF campaigner, at a press conference on the opening day of a World Healt= h > Organization summit being held in Mexico City this week. > > While the summit will focus on improving the research of health care > systems how to apply existing medicines and technologies in the most cost > effective ways 't Hoen said developed nations cannot ignore their > responsibility to fund drug research for the world's "neglected diseases.= " > Most drug research is focused on finding cures to the ailments common in > the lucrative markets of the United States and Europe. Meanwhile, disease= s > such as malaria that afflict only poor populations have been mostly ignor= ed > by drug companies. > > Of the nearly 1,400 new drugs developed between 1975 and 1999, only 16 we= re > for tropical diseases and tuberculosis, conditions that account for more > than 10 percent of global illnesses, according to MSF. > > As a consequence of the lack of new research, the treatment of neglected > diseases relies on old, often highly toxic, medicines. > > Despite a global increase in cases of TB, diagnosis of the disease still > relies on methods dating from 1882 while treatment depends on drugs > developed 40 to 60 years ago. > > Virginia Morrison, an MSF nurse working in Angola, said health workers in > the field see every day the suffering caused by the lack of new drugs. > > Morrison said she only had two drugs to work with in treating severe > infections of sleeping sickness, which afflicts an estimated 500,000 peop= le > a year and kills 60,000. > > One of the drugs "is a horrible 55-year-old drug which burns the veins an= d > kills one in 20 patients" and the other is ill-adapted for field conditio= ns > in Africa, Morrison said. > > "Our patients are sometimes more afraid of dying from the treatment than = of > dying from the disease," she said. "Having only these options is > unacceptable medical practice." > > "Even though there is a lot of basic research into the disease, the resul= ts > are not being translated into new, effective, safe and easy-to-use drugs.= " > Dr. Bernard Pecoul, head of the Drugs for Neglected Diseases initiative > (DNDi) criticized both the United States and the European Commission for > failing to fund research for the diseases that don't interest > pharmaceutical companies. > > "There needs to be a shift in political agendas," Pecoul said. > > More than 40 percent of the world's total spending on health research is > provided by the public sector, mostly from the United States and Europe, > according to a report by the Global Forum for Health Research that is > hosting a parallel conference to the ministers summit. > > But 't Hoen said public research has become "contaminated by market drive= n > logic," noting that public funds are used mostly to research the same > diseases that interest the private sector. > > She said new schemes had to be developed to redirect public research fund= s > toward neglected diseases. > > "The WHO needs to take the leadership on this, you can't just keep settin= g > goals without saying how you are going to achieve them," said 't Hoen. "W= e > need to look setting up a radically different system to set priorities." > > World Health Leaders Call for New Research Goals > > Tue 16 November, 2004 22:30 > > By Lorraine Orlandi > > MEXICO CITY (Reuters) - Global health leaders meeting in Mexico this week > want nations of the world to spend more on medical research, not only to > develop new cures but to make those now on the market available to the > poor. > > Existing tools as simple as mosquito nets can cut deep into massive healt= h > problems such as malaria in developing nations, but research is needed to > find ways to best use them, organizers of a summit for health research sa= id > at the start of the four-day event in Mexico City on Tuesday. > > "The outlook is bleak (without such research) in terms of reaching health > gains that we know are possible," Dr. Tim Evans, assistant director-gener= al > of the World Health Organization, told a news conference. > > Health ministers from 70 countries, joined by scientists, international > leaders and private industry, will reiterate a call for governments to > dedicate 2 percent of their health budgets to medical research, according > to a draft of a declaration expected to be issued later in the week. > > Funding for medical research is rising, and the number of public-private > partnerships to develop new drugs has increased dramatically, providing > promise for future treatments. > > Yet, hundreds of thousands of women die every year in pregnancy, most of > them in developing nations, from conditions that are often easily treatab= le > or preventable. > > HALF OF DEATHS EASILY PREVENTABLE > > While such long-standing problems persist, poor populations are also > ravaged by newer diseases like AIDS and new pandemic infections emerge at= a > rate of about one a year. > > In a report this month the World Health Organization said more effective > research could prevent half the world's deaths with simple and > cost-effective methods. > > For example, mosquito nets could dramatically reduce children's deaths fr= om > malaria in some African nations, but a small minority of children now hav= e > then, Evans said. Local authorities need programs to deliver them > universally. > > One district in Tanzania reduced child mortality by 40 percent simply by > making a local study of health problems and reallocating its health budge= t > of about $2 per person accordingly, he said. > > The independent humanitarian medical aid agency Medecins Sans Frontieres, > or MSF, said on Tuesday that despite brave talk, health leaders need to > take more drastic steps to focus medical research on people suffering fro= m > "neglected diseases" in poor countries. > > "The current system is failing people in developing countries in a number > of ways," said Ellen Hoen, who runs the MSF campaign for access to > essential medicines. > > MSF experts singled out diseases including malaria, tuberculosis, AIDS an= d > sleeping sickness that are not being adequately treated in developing > countries. > > In the case of sleeping sickness, a disease that causes madness and then > death and which is prevalent in Africa and carried by the tsetse fly, > treatments being used are half a century old. > > "The national protocol for second-stage sleeping sickness in Angola is > melarsoprol, a horrible 55-year-old drug which burns the veins and kills > one in 20 patients," said Virginia Morrison, an MSF nurse working in > Angola. > > **************************************** > Sean Healy > Information Officer > Campaign for Access to Essential Medicines > M=E9decins Sans Fronti=E8res > Geneva, Switzerland > tel ++41-22-8498 401 > fax ++41-22-8498 404 > mobile tel ++41-79-239 9271 > sean.healy@geneva.msf.org > www.accessmed-msf.org > > _______________________________________________ > Ip-health mailing list > Ip-health@lists.essential.org > http://lists.essential.org/mailman/listinfo/ip-health Regards, -- Jeffrey A. Williams Spokesman for INEGroup LLA. - (Over 134k members/stakeholders strong!) "Be precise in the use of words and expect precision from others" - Pierre Abelard "If the probability be called P; the injury, L; and the burden, B; liability depends upon whether B is less than L multiplied by P: i.e., whether B is less than PL." United States v. Carroll Towing (159 F.2d 169 [2d Cir. 1947] =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D= =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D= =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D Updated 1/26/04 CSO/DIR. Internet Network Eng. SR. Eng. Network data security IDNS. div. of Information Network Eng. INEG. INC. E-Mail jwkckid1@ix.netcom.com Registered Email addr with the USPS Contact Number: 214-244-4827 From jwkckid1@ix.netcom.com Thu Nov 18 12:53:03 2004 From: jwkckid1@ix.netcom.com (Jeff Williams) Date: Thu Nov 18 12:53:03 2004 Subject: [Ip-health] RFID Labels On Prescription Drug Bottles Message-ID: <419CA091.7D066FD2@ix.netcom.com> All, As if perscription drugs were not already overpriced... and Could this be an unecessary intrusion into a persons medical privacy? Seems to me anyway that such is at least a possibility... FYI, "The New York Times is reporting that the Food and Drug Administration and several major drug makers are expected to announce an agreement Monday to put [1]tiny radio antennas on the labels of millions of medicine bottles to combat counterfeiting and fraud. RFID labels provide a unique identifier that is almost impossible to copy. When pharmacists receive delivery, they should be able to pass a wand over the bottles and, through an online database, check the history of each. Each label costs 20 to 50 cents." See: http://www.nytimes.com/2004/11/15/health/15drug.html Regards, -- Jeffrey A. Williams Spokesman for INEGroup LLA. - (Over 134k members/stakeholders strong!) "Be precise in the use of words and expect precision from others" - Pierre Abelard "If the probability be called P; the injury, L; and the burden, B; liability depends upon whether B is less than L multiplied by P: i.e., whether B is less than PL." United States v. Carroll Towing (159 F.2d 169 [2d Cir. 1947] =============================================================== Updated 1/26/04 CSO/DIR. Internet Network Eng. SR. Eng. Network data security IDNS. div. of Information Network Eng. INEG. INC. E-Mail jwkckid1@ix.netcom.com Registered Email addr with the USPS Contact Number: 214-244-4827 From mpalmedo@cptech.org Thu Nov 18 13:31:01 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Thu Nov 18 13:31:01 2004 Subject: [Ip-health] USTR: US-AU FTA to take effect Jan 1, as planned Message-ID: <419CE847.4090301@cptech.org> http://www.ustr.gov/assets/Document_Library/Press_Releases/2004/November/as= set_upload_file236_6752.pdf FOR IMMEDIATE RELEASE: CONTACT: RICHARD MILLS / NEENA MOORJANI (202) 395-3230 NOVEMBER 17, 2004 U.S. and Australia Address FTA Implementation Issues - FTA to Take Effect January 1, as Planned SANTIAGO, CHILE ---- U.S. Trade Representative Robert B. Zoellick met with Australian Trade Minister Mark Vaile today and finalized arrangements to bring the Australia-United States Free Trade Agreement (FTA) into force on January 1, 2005. =93We have addressed U.S. concerns over Australia=92s implementation of the agreement and I am pleased to announce that the FTA will go into force on January 1, the earliest possible opportunity,=94 Zoellick said. Today, the United States and Australia exchanged diplomatic notes certifying that each country respectively has completed its internal requirements to allow the agreement to enter into force on January 1, 2005. =93This FTA will eliminate more than 99 percent of tariffs on industrial goods between the two countries,=94 said Zoellick. =93By opening markets fo= r goods and services, promoting investment, enhancing protection for intellectual property, and freeing electronic commerce, this Agreement will create real economic opportunities in both the United States and Australia for businesses, farmers, ranchers, and workers,=94 he said. The United States had raised concerns with Australia that its FTA implementing legislation, which its Parliament passed in August 2004, did not fully implement a number of the FTA commitments it made on intellectual property. Australia has committed to take steps, including legislative and regulatory changes, to address these issues. =93U.S. businesses are eager to begin reaping the benefits of this historic agreement,=94 Zoellick said. =93I am pleased that we were able to work together to address U.S. concerns and look forward to working together to ensure full and faithful implementation of the Agreement,=94 he continued. Background Negotiations on the Australia-U.S. FTA began in March 2003, and President George W. Bush and Prime Minister John Howard made it a priority for both countries to conclude the Agreement. The negotiations were completed on February 8, 2004 and the Agreement was signed on May 18, 2004. The Congress approved the Agreement in July 2004, and the President signed the measure into law on August 3, 2004. The U.S.-Australia FTA is the first FTA between the United States and a developed country since the U.S.-Canada Free Trade Agreement in 1988. It is a 21st century agreement that reflects the modern globalized economy. The FTA will open markets and streamline mutual access in intellectual property, services, government procurement, e-commerce, and investment. Australia is a large and growing trade and investment partner of the United States, and in 2003 was America=92s 14th largest export market for goods. Two-way goods and services trade is nearly $29 billion, a 53-percent increase since 1994. Two-way foreign direct investment is about $61 billion. Australia purchases more goods from the United States than they do from any other country, and the United States enjoys a bilateral goods and services trade surplus of $9 billion. Australia is a key export market for important U.S. manufacturing sectors such as aircraft, autos and auto parts, machinery, computers and electronic products, chemicals, and wood and paper products. Each of the 50 U.S. states exports to Australia, and Australia is among the top 25 export destinations for 48 of the 50 states. The leading states exporting to Australia are Washington, California, Illinois, Texas, Michigan, New York, Ohio, Pennsylvania, and Florida. The United States is working to open markets globally in the Doha World Trade Organization (WTO) negotiations; regionally through APEC and the Free Trade Area (FTAA) of the Americas negotiations; and bilaterally, via FTAs. New and pending FTA partners, taken together, would constitute America=92s third largest export market and the sixth largest economy in the world. # # # From mpalmedo@cptech.org Thu Nov 18 16:32:02 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Thu Nov 18 16:32:02 2004 Subject: [Ip-health] WHO: "Priority Medicines for Europe and the World Project - A Public Health Approach to Innovation" Message-ID: <419CFE01.9030306@cptech.org> http://www.who.int/mediacentre/news/releases/2004/pr83/en/ Landmark report could influence the future of medicines in Europe and the world - Gaps in pharmaceutical research and innovation can be closed, says WHO report 18 NOVEMBER 2004 | GENEVA -- The World Health Organization (WHO) today releases a groundbreaking report which recommends ways in which pharmaceutical research and innovation can best address health needs and emerging threats in Europe and the world. Priority Medicines for Europe and the World, commissioned by the Dutch Government as current president of the European Union (EU), identifies a priority list of medicines for Europe and the rest of the world, taking into account Europe's ageing population, the increasing burden of non-communicable illnesses in developing countries and diseases which persist in spite of the availability of effective treatments. The report looks at the gaps in research and innovation for these medicines and provides specific policy recommendations on creating incentives and closing those gaps. At present, pharmaceutical research and development are based on a market-driven incentive system relying primarily on patents and protected pricing as a prime financing mechanism. As a result, a number of health needs are left unaddressed. The report identifies gaps for diseases for which treatments do not exist, are inadequate or are not reaching patients. Threats to public health such as antibacterial resistance or pandemic influenza, for which present treatments or preventive measures are unlikely to be effective in the future, also require immediate action. "This report identifies health gaps and potential solutions. It is particularly timely for a continent where an ageing population faces increasing health problems, and for a world where old and new threats no longer respect national borders," said Dr. LEE Jong-wook, Director-General of WHO from the Ministerial Summit on Health Research, taking place in Mexico this week. In addition, the report addresses obstacles where effective medicines could be better delivered to the patient. It emphasizes fixed dose combination medicines (medicines which include more than one active ingredient in one pill) as worthy of further research and development. Finally, it looks at particular groups such as children, women and the elderly, who have frequently been neglected in the scientific or medicine development process. The 17 priority conditions identified by the report are: * Future public health threats: infections due to antibacterial resistance; pandemic influenza; * Diseases for which better formulations are required: cardiovascular disease (secondary prevention); diabetes; postpartum haemorrhage, paediatric HIV/AIDS, depression in the elderly and adolescents; * Diseases for which biomarkers are absent: Alzheimer disease; osteoarthritis; * Diseases for which basic and applied research is required: cancer; acute stroke; * Neglected diseases or areas: tuberculosis; malaria and other tropical infectious diseases such as trypanosomiasis, leishmaniasis and Buruli ulcer, HIV vaccine; * Diseases for which prevention is particularly effective: chronic obstructive pulmonary disease including smoking cessation; alcohol use disorders: alcoholic liver diseases and alcohol dependency. The report suggests that Europe can and should play a global leadership role in public health, as reflected by its history of social services provision and social safety nets for all citizens. In many developing countries, the poor are increasingly affected by the chronic diseases that are widespread in Europe, including cardiovascular disease, diabetes, tobacco-related diseases and mental illnesses such as depression. Moreover, the ten countries that joined the EU in 2004 have additional public health challenges. For a number of diseases that affect people in all members of the EU, no effective and safe medicinal treatment is yet available (e.g. Alzheimer disease and several cancers). For some diseases, potentially large markets exist for medicines (e.g. breast cancer) and associated pharmaceutical research is likely to be intensive for certain therapeutic classes. For other categories of medicines, the number of patients is low (e.g. cystic fibrosis) or the market-driven pharmaceutical industry has failed to pursue research and development (e.g., new medicines for tuberculosis). Innovative solutions The report suggests that efforts to shorten the medicine development process without compromising patient safety would greatly assist in promoting pharmaceutical innovation. For instance, the EU could create and support a broad research agenda through which the European Agency for Evaluating Medicines (EMEA), national regulatory authorities, scientists, industry and the public would critically review the regulatory requirements within the medicine development process for their relevance, costing, and predictive value. Health authorities are responsible for medicines reimbursement decisions that aim to ensure safe and effective treatment for all patients, while reconciling this with budgetary constraints. Health and reimbursement authorities and manufacturers should agree on general principles for the evaluation of future medicines. For example, the EU Commission and national authorities should support a research agenda on the various methods of rewarding clinical performance and linking prices to national income levels. The report authors believe that these measures will help encourage industry to invest in the discovery of innovative medicines that address priority health care needs. The report maintains that where the market is strong and the problem is poor understanding of the basic biology of the disease, investment in basic research and in facilitating innovation by the pharmaceutical industry will be needed. Where the biology is well understood but the market is weak, public support for breaching the gap between basic and clinical research =97 possibly through public-private partnerships and other not-for-profit product development initiatives =97 will be the preferred solution. Where the biology is not well understood and there is also a weak market, then biological research can be supported while market incentives are created for the pharmaceutical industry, through reducing barriers to innovation and through improving reimbursement rewards= . The report points out that major pharmaceutical gaps have been closed in the past. For example, until 1975 the main treatment for severe peptic ulcer - a common ailment - was surgery. Following a long period of focused research in biological mechanisms underlying ulcer disease, effective medical treatments were discovered. These breakthrough discoveries, combined with the discovery that most ulceration was caused by a bacteria treatable with antibiotics, made surgery unnecessary. The recommendations contained in the report could have a significant impact on research innovation and policy, with support from European leaders. The report will be discussed at a High Level Meeting in the Hague on November 18th 2004. RELATED LINKS - Priority Medicines for Europe and the World http://mednet3.who.int/prioritymeds/ - Essential medicines http://www.who.int/topics/essential_medicines/en/ For more information contact: Ms Daniela Bagozzi Telephone: +41 22 791 4544 Mobile phone: +41 79 475 5490 Email: bagozzid@who.int From B.Baker@neu.edu Thu Nov 18 18:43:00 2004 From: B.Baker@neu.edu (B.Baker@neu.edu) Date: Thu Nov 18 18:43:00 2004 Subject: [Ip-health] RFID labels on prescription drug bottles Message-ID: I don't think the risk of rfid labels on wholesale drug bottles is likely to represent an invasion of privacy for individual consumers. The article makes clear that the tracking devises will be placed on larger bottles used by pharmacies to fill precriptions and not on individual consumer's bottles (at least at this time!). However, there is a real danger that this requirement will be used as an additional requirement for U.S. purchased pharmaceutical in the PEPFAR program and elsewhere. The request for proposals that the U.S. Global AIDS office issued re its proposed Supply Chain Management System included a requirement of that the Procurement Manager only buy and track products with RFID labels or barcode labels (page 9). Although it will become standard for U.S./FDA registered producers to manufacture and ship medicines with these labels, this requirement will certainly be a technical deterrent to overseas generic producers many of which may not yet have the barcode technology. Moreover, the labels will add to the cost of products. Brook From pdavis@healthgap.org Fri Nov 19 10:32:01 2004 From: pdavis@healthgap.org (pdavis@healthgap.org) Date: Fri Nov 19 10:32:01 2004 Subject: [Ip-health] People with HIV/AIDS From Around the World Condemn Bush Administration's Attacks on the Global Fund to Fight AIDS, Tuberculosis and Malaria and the World Health Organization In-Reply-To: Message-ID: <3789528.1100823342930.JavaMail.teamon@b217.teamon.com> From: Gregg Gonsalves People with HIV/AIDS From Around the World Condemn Bush Administration's Attacks on the Global Fund to Fight AIDS, Tuberculosis and Malaria and the World Health Organization People with HIV/AIDS and their advocates today strongly condemn the attempt= s by the United States to block new funding for HIV/AIDS programs around the world through the Global Fund to Fight AIDS, Tuberculosis and Malaria and its systematic attempts to undermine the work of the World Health Organization and its efforts to ensure that 3 million people in the developing world receive HIV treatment by the end of 2005. The suspension, proposed by the United States, of new funding for HIV, TB and malaria programs by the Global Fund, will lead to the loss of countless numbers of lives and to thousands of new infections. While we recognize there have been some problems in the disbursement of grants and implementation of programs through the Global Fund, this is not an excuse for suspending new grants to countries that desperately need this support. A fifth round of funding by the Global Fund would provide vital resources t= o nations around the world confronting these pandemics. We also condemn the US government's attacks and those by right-wing think tanks associated with the Administration on the World Health Organization and its prequalification process for evaluating antiretroviral drugs. Whil= e there have been specific problems with the dossiers submitted by some of th= e manufacturers of generic AIDS drugs to the WHO, these problems were recognized and are being handled by the agency. We urge the US government to work with the WHO to strengthen its prequalification program rather than setting up its own regulatory process for these drugs at the US Food and Drug Administration as well as duplicative supply and procurement programs in the developing world. With these events taken together, we believe that the US government is seeking to draw control of global AIDS programs under its own leadership rather than supporting multilateral responses through the WHO and the Globa= l Fund. The United States cannot go it alone in the fight against AIDS and must work in cooperation with the global community. It should not abuse it= s power in setting the agenda in the fight against this disease, particularly when it has championed abstinence-only prevention programs that do not work and expensive brand-name drugs that are unsustainable solutions for the developing world. Dar=EDo Abarca Ecuadorian Coalition of People Living with HIV/AIDS Ecuador Zackie Achmat Treatment Action Campaign South Africa Pablo Anamaria Peruvian Coordination of People Living with HIV/AIDS National Coalition for Acess to Treatment "Group for Life" Peru Collette Campher AIDS & Rights Alliance for Southern Africa Namibia Robert Carr Jamaica AIDS Support Jamaica Christa Cepuch Health Action International (HAI) Africa Kenya Charitable Foundation "Spodivannya" Ukraine Enrique Chavez AID FOR AIDS United States Igor Chilcevschii Association of PLWHAs "CREDINTA" Moldova Polly Clayden HIV i-Base England Michaela Clayton AIDS Law Unit of the Legal Assistance Centre Namibia Believe Dhliwayo & Tapiwanashe Kujinga Zimbabwe Activists on HIV/AIDS Zimbabwe Jaume Fabr=E9s gTt, Grupo de Trabajo sobre Tratamientos del VIH Spain Stu Flavell Global Network of People Living with HIV/AIDS The Netherlands FRONTAIDS Russia Loon Gangte Delhi Network of Positive People (DNP+) India Gregg Gonsalves Gay Men's Health Crisis United States Chris W. Green Spiritia Foundation Indonesia Mauro Guarinieri European AIDS Treatment Group Italian League for fighting AIDS (LILA) Italian Community Advisory Board Italy Mark Harrington Treatment Action Group United States Jodi Jacobson Center for Health and Gender Equity United States James Kamau Kenya Treatment Access Movement Kenya Galina Kaminskaya CNF "All together" Ukraine Nataliya Kitsenko Odessa Charity Fund "The Way Home" Ukraine Svilen Konov Plus Minus Foundation Bulgaria Kasia Malinowska-Sempruch International Harm Reduction Development Program Open Society Institute United States/Poland Othman Mellouk ALCS Morocco Lydia Mungherera National Forum of PWA Networks/Health Rights Action Group Uganda Vladimir Musatov Humanitarian ACTION Russia Rosette Mutambi Coalition for Health Promotion and Social Development Uganda Dorothy Onyango Women Fighting AIDS in Kenya - WOFAK Kenya Elizabeth Owiti Healthpartners Kenya Valeri Pahomov, Chair of the Board Odessa charitable foundation "For future without AIDS Ukraine Rodrigo Pascal Vivo Positivo Chile Germ=E1n Humberto Rinc=F3n Perfetti Asociaci=F3n L=EDderes en Acci=F3n Colombia Oswaldo A. Rada RedLa+ Latinamerican Network of People living with HIV/AIDS Fundaci=F3n Apoyo y Solidaridad "FAS" Colombia Katja Roll & Rainer Seybold Action against AIDS Germany Germany R=E9gis Samba-Kounzi Act Up-Paris France Anya Sarang & Raminta Stuikyte Central Eastern European Harm Reduction Network Elena Traicu and Lucia Stirbu UNOPA (National Union of the Organizations of HIV/AIDS Affected Peoples) Romania Alice Welbourn International Community of Women Living with HIV/AIDS United Kingdom NOTE: If an email bounces back to you from GMHC, please copy email to my personal account at gregggonsalves@earthlink.net . Gregg Gonsalves Director of Treatment and Prevention Advocacy Gay Men's Health Crisis 119 West 24th Street New York, NY 10011 Phone: 212-367-1169 Mobile: 646-250-8130 Fax: 212-367-1235 Email: greggg@gmhc.org or gregggonsalves@earthlink.net ------ End of Forwarded Message From jwkckid1@ix.netcom.com Fri Nov 19 10:32:11 2004 From: jwkckid1@ix.netcom.com (Jeff Williams) Date: Fri Nov 19 10:32:11 2004 Subject: [Ip-health] RFID Labels On Prescription Drug Bottles References: Message-ID: <419DA74F.23C8E24B@ix.netcom.com> Kevin and all, Price discrimination is a good thing when applied independently as it can spur price competition. However as the cost of RFID tags add cost to the consumer, although slightly as currently reported, I cannot see that RFID tags will unlikely be used to reduce cost to consumers, but rather aid in determining what drug families and/or types are most broadly used/consumed, and as such change or otherwise tend to adjust the Big Pharma industries production emphasis... This may or may not be in the best overall interest of the public health... Kevin Outterson wrote: > RFID tags will permit pharmaceutical companies to monitor their supply > chains from their factories to the consumer. This will enable even more > dramatic market segmentation and price discrimination by the companies. > Whether stronger pharmaceutical price discrimination is a good idea is > an open question. > > Kevin Outterson > > Associate Professor of Law > West Virginia University > 304 293 8282 > kevin.outterson@mail.wvu.edu > LL.M. (Cantab.) > J.D. (Northwestern) > SSRN Author Page: ssrn.com/author=340746 > > CONFIDENTIALITY STATEMENT > The information transmitted is intended only for the person or entity to > which it is addressed and may contain confidential and/or privileged > material. Any review, retransmission, dissemination or other use of, or > taking of any action in reliance upon, this information by persons or > entities other than the intended recipient or recipients is prohibited. > If you received this in error, please contact the sender and delete the > material from any computer. > > >>> Jeff Williams 18/11/04 8:16 >>> > All, > > As if perscription drugs were not already overpriced... > > and > > Could this be an unecessary intrusion into a persons medical > privacy? Seems to me anyway that such is at least a possibility... > > FYI, > "The New York Times is reporting that the Food and Drug > Administration and several major drug makers are expected to announce an > > agreement Monday to put [1]tiny radio antennas on the labels of millions > > of medicine bottles to combat counterfeiting and fraud. RFID labels > provide a unique identifier that is almost impossible to copy. When > pharmacists receive delivery, they should be able to pass a wand over > the > bottles and, through an online database, check the history of each. Each > > label costs 20 to 50 cents." > > See: http://www.nytimes.com/2004/11/15/health/15drug.html > > Regards, > -- > Jeffrey A. Williams > Spokesman for INEGroup LLA. - (Over 134k members/stakeholders strong!) > "Be precise in the use of words and expect precision from others" - > Pierre Abelard > > "If the probability be called P; the injury, L; and the burden, B; > liability depends upon whether B is less than L multiplied by > P: i.e., whether B is less than PL." > United States v. Carroll Towing (159 F.2d 169 [2d Cir. 1947] > =============================================================== > Updated 1/26/04 > CSO/DIR. Internet Network Eng. SR. Eng. Network data security > IDNS. div. of Information Network Eng. INEG. INC. > E-Mail jwkckid1@ix.netcom.com > Registered Email addr with the USPS > Contact Number: 214-244-4827 > > _______________________________________________ > Ip-health mailing list > Ip-health@lists.essential.org > http://lists.essential.org/mailman/listinfo/ip-health Regards, -- Jeffrey A. Williams Spokesman for INEGroup LLA. - (Over 134k members/stakeholders strong!) "Be precise in the use of words and expect precision from others" - Pierre Abelard "If the probability be called P; the injury, L; and the burden, B; liability depends upon whether B is less than L multiplied by P: i.e., whether B is less than PL." United States v. Carroll Towing (159 F.2d 169 [2d Cir. 1947] =============================================================== Updated 1/26/04 CSO/DIR. Internet Network Eng. SR. Eng. Network data security IDNS. div. of Information Network Eng. INEG. INC. E-Mail jwkckid1@ix.netcom.com Registered Email addr with the USPS Contact Number: 214-244-4827 From jwkckid1@ix.netcom.com Fri Nov 19 10:32:21 2004 From: jwkckid1@ix.netcom.com (Jeff Williams) Date: Fri Nov 19 10:32:21 2004 Subject: [Ip-health] WHO: "Priority Medicines for Europe and the World Project - A Public Health Approach to Innovation" References: <419CFE01.9030306@cptech.org> Message-ID: <419DBC1D.597E225C@ix.netcom.com> Mike and all, WHO has some very good ideas here that have been extolled by others before. How does WHO intent to actually implement the ideas in this report? Or do they? Mike Palmedo wrote: > http://www.who.int/mediacentre/news/releases/2004/pr83/en/ > > Landmark report could influence the future of medicines in Europe and > the world - > Gaps in pharmaceutical research and innovation can be closed, says WHO > report > > 18 NOVEMBER 2004 | GENEVA -- The World Health Organization (WHO) today > releases a groundbreaking report which recommends ways in which > pharmaceutical research and innovation can best address health needs and > emerging threats in Europe and the world. > > Priority Medicines for Europe and the World, commissioned by the Dutch > Government as current president of the European Union (EU), identifies a > priority list of medicines for Europe and the rest of the world, taking > into account Europe's ageing population, the increasing burden of > non-communicable illnesses in developing countries and diseases which > persist in spite of the availability of effective treatments. The report > looks at the gaps in research and innovation for these medicines and > provides specific policy recommendations on creating incentives and > closing those gaps. > > At present, pharmaceutical research and development are based on a > market-driven incentive system relying primarily on patents and > protected pricing as a prime financing mechanism. As a result, a number > of health needs are left unaddressed. > > The report identifies gaps for diseases for which treatments do not > exist, are inadequate or are not reaching patients. Threats to public > health such as antibacterial resistance or pandemic influenza, for which > present treatments or preventive measures are unlikely to be effective > in the future, also require immediate action. > > "This report identifies health gaps and potential solutions. It is > particularly timely for a continent where an ageing population faces > increasing health problems, and for a world where old and new threats no > longer respect national borders," said Dr. LEE Jong-wook, > Director-General of WHO from the Ministerial Summit on Health Research, > taking place in Mexico this week. In addition, the report addresses > obstacles where effective medicines could be better delivered to the > patient. It emphasizes fixed dose combination medicines (medicines which > include more than one active ingredient in one pill) as worthy of > further research and development. Finally, it looks at particular groups > such as children, women and the elderly, who have frequently been > neglected in the scientific or medicine development process. > > The 17 priority conditions identified by the report are: > > * Future public health threats: infections due to antibacterial > resistance; pandemic influenza; > > * Diseases for which better formulations are required: cardiovascular > disease (secondary prevention); diabetes; postpartum haemorrhage, > paediatric HIV/AIDS, depression in the elderly and adolescents; > > * Diseases for which biomarkers are absent: Alzheimer disease; > osteoarthritis; > > * Diseases for which basic and applied research is required: cancer; > acute stroke; > > * Neglected diseases or areas: tuberculosis; malaria and other tropical > infectious diseases such as trypanosomiasis, leishmaniasis and Buruli > ulcer, HIV vaccine; > > * Diseases for which prevention is particularly effective: chronic > obstructive pulmonary disease including smoking cessation; alcohol use > disorders: alcoholic liver diseases and alcohol dependency. > > The report suggests that Europe can and should play a global leadership > role in public health, as reflected by its history of social services > provision and social safety nets for all citizens. In many developing > countries, the poor are increasingly affected by the chronic diseases > that are widespread in Europe, including cardiovascular disease, > diabetes, tobacco-related diseases and mental illnesses such as > depression. Moreover, the ten countries that joined the EU in 2004 have > additional public health challenges. > > For a number of diseases that affect people in all members of the EU, no > effective and safe medicinal treatment is yet available (e.g. Alzheimer > disease and several cancers). For some diseases, potentially large > markets exist for medicines (e.g. breast cancer) and associated > pharmaceutical research is likely to be intensive for certain > therapeutic classes. For other categories of medicines, the number of > patients is low (e.g. cystic fibrosis) or the market-driven > pharmaceutical industry has failed to pursue research and development > (e.g., new medicines for tuberculosis). > > Innovative solutions > > The report suggests that efforts to shorten the medicine development > process without compromising patient safety would greatly assist in > promoting pharmaceutical innovation. For instance, the EU could create > and support a broad research agenda through which the European Agency > for Evaluating Medicines (EMEA), national regulatory authorities, > scientists, industry and the public would critically review the > regulatory requirements within the medicine development process for > their relevance, costing, and predictive value. > > Health authorities are responsible for medicines reimbursement decisions > that aim to ensure safe and effective treatment for all patients, while > reconciling this with budgetary constraints. Health and reimbursement > authorities and manufacturers should agree on general principles for the > evaluation of future medicines. For example, the EU Commission and > national authorities should support a research agenda on the various > methods of rewarding clinical performance and linking prices to national > income levels. The report authors believe that these measures will help > encourage industry to invest in the discovery of innovative medicines > that address priority health care needs. > > The report maintains that where the market is strong and the problem is > poor understanding of the basic biology of the disease, investment in > basic research and in facilitating innovation by the pharmaceutical > industry will be needed. Where the biology is well understood but the > market is weak, public support for breaching the gap between basic and > clinical research =97 possibly through public-private partnerships and > other not-for-profit product development initiatives =97 will be the > preferred solution. Where the biology is not well understood and there > is also a weak market, then biological research can be supported while > market incentives are created for the pharmaceutical industry, through > reducing barriers to innovation and through improving reimbursement rewar= ds. > > The report points out that major pharmaceutical gaps have been closed in > the past. For example, until 1975 the main treatment for severe peptic > ulcer - a common ailment - was surgery. Following a long period of > focused research in biological mechanisms underlying ulcer disease, > effective medical treatments were discovered. These breakthrough > discoveries, combined with the discovery that most ulceration was caused > by a bacteria treatable with antibiotics, made surgery unnecessary. > > The recommendations contained in the report could have a significant > impact on research innovation and policy, with support from European > leaders. The report will be discussed at a High Level Meeting in the > Hague on November 18th 2004. > > RELATED LINKS > > - Priority Medicines for Europe and the World > http://mednet3.who.int/prioritymeds/ > > - Essential medicines > http://www.who.int/topics/essential_medicines/en/ > > For more information contact: > > Ms Daniela Bagozzi > Telephone: +41 22 791 4544 > Mobile phone: +41 79 475 5490 > Email: bagozzid@who.int > _______________________________________________ > Ip-health mailing list > Ip-health@lists.essential.org > http://lists.essential.org/mailman/listinfo/ip-health Regards, -- Jeffrey A. Williams Spokesman for INEGroup LLA. - (Over 134k members/stakeholders strong!) "Be precise in the use of words and expect precision from others" - Pierre Abelard "If the probability be called P; the injury, L; and the burden, B; liability depends upon whether B is less than L multiplied by P: i.e., whether B is less than PL." United States v. Carroll Towing (159 F.2d 169 [2d Cir. 1947] =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D= =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D= =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D Updated 1/26/04 CSO/DIR. Internet Network Eng. SR. Eng. Network data security IDNS. div. of Information Network Eng. INEG. INC. E-Mail jwkckid1@ix.netcom.com Registered Email addr with the USPS Contact Number: 214-244-4827 From relliott@aidslaw.ca Fri Nov 19 11:03:03 2004 From: relliott@aidslaw.ca (Richard Elliott) Date: Fri Nov 19 11:03:03 2004 Subject: [Ip-health] (no subject) Message-ID: <20041119154512.UYRE1665.tomts24-srv.bellnexxia.net@RichardPC> This is a multi-part message in MIME format. -- [ Picked text/plain from multipart/alternative ] GLOBE & MAIL Friday, November 19, 2004 (Page A7, Toronto edition) http://www.theglobeandmail.com/servlet/story/RTGAM.20041119.wxdrug19/BNStor= y/National/ Liberals' plan to get discount medicines to poor nations panned By STEVEN CHASE >From Friday's Globe and Mail POSTED AT 9:53 AM EST OTTAWA =97 The Liberal government's much-touted plan to get discount medici= ne to poor nations is flawed and may never succeed in sending a significant amount of drugs overs= eas, critics and aid groups warn. The charge comes just as Prime Minister Paul Martin heads for meetings next= week in Africa -- a continent in dire need of affordable medicine to treat health crises from A= IDS to malaria to tuberculosis. No drugs have yet been exported under the Jean Chr=E9tien Pledge to Africa = Act, which was first tabled in Parliament more than one year ago. It passed in mid-May and the Liberals= touted the measure in pre-election ads. Six months later, the law has not yet come into force because Ottawa is sti= ll hammering out supporting regulations. Relief groups say they fear that drugs won't start flowing even after the b= ill takes effect. They say that generic-drug firms -- which are supposed to play a key role i= n the process -- have not embraced a proposal from M=E9decins sans fronti=E8res (Doctors Without Bord= ers) to manufacture a handful of drugs the group wants to see copied and exported. "I think [the government] should be ashamed that . . . we haven't even mana= ged to get a first agreement to produce drugs," said Rachel Kiddell-Monroe, a MSF official who= has worked with Ottawa on the law. "If you asked me a few months ago, I would have said [exports would begin w= ithin] a year's time, but if you ask me today, I am not sure they are ever going to be shipped." Generic-drug companies say they are frustrated by the law, which they say m= akes it costly and risky to copy and export drugs. "It's an uncertain, difficult, lengthy process for our companies to basical= ly sell below cost or donate products they don't even make [yet]," said Jeff Connell, spokesman f= or the Canadian Generic Pharmaceutical Association. "It's unclear how it's all going to work out." The law is supposed to eliminate legal hurdles for generic-drug companies t= o make cheap copies of patented medicine for export. This follows a 2003 World Trade Organization = agreement that said countries may breach drug patents to help poor nations tackle health crises= . Ian Jack, spokesman for Industry Minister David Emerson, says it's not up t= o Ottawa to see that medicines are exported: It's up to the private sector. "We have created a framework that allows these drugs to be exported to coun= tries in need. It's now up to the companies and [non-governmental organizations] to use this proces= s. At the end of the day the government doesn't manufacture or sell these products," he said. Industry Canada official =C9ric Dagenais said the law will probably come in= to force early next year. He said the legislation is important -- regardless of whether it leads to s= hipments -- because it offers an alternative drug supplier when poor countries negotiate with pate= nted-drug makers. The generic industry says it fears Ottawa has made it too easy for patent-h= olding drug companies to sue generic companies in the case of a dispute over a future transaction. Canada's Research-based Pharmaceutical Companies, which represent brand nam= es, say generics are just making excuses. "It seems the generics are spending a lot of energy on reas= ons why they can't do this," spokesman Jacques Lefebvre said. "As for being worried about lawsuit= s . . . if you respect the regulations that are in place, you shouldn't worry about lawsuits." Two original backers of the legislation, Liberal cabinet minister Pierre Pe= ttigrew and former industry minister Allan Rock, could not be reached for comment last night. Ms. Kiddell-Monroe said Ottawa must make exporting drugs a higher priority. "Countries like Canada are needed to fill this yawning gap for medicine." __________________________________ Richard Elliott Director, Legal Research & Policy Canadian HIV/AIDS Legal Network 890 Yonge Street, Suite 700 Toronto, Ontario, Canada M4W 3P4 Tel: +1 (416) 595-1666 Fax: +1 (416) 595-0094 E-mail: relliott@aidslaw.ca Web: www.aidslaw.ca -- From mpalmedo@cptech.org Fri Nov 19 11:50:01 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Fri Nov 19 11:50:01 2004 Subject: [Ip-health] UN News: WHO seeks to close gaps in pharmaceutical research Message-ID: <419E21B2.3030805@cptech.org> http://www.un.org/apps/news/story.asp?NewsID=3D12570&Cr=3D&Cr1=3D# UN health agency seeks to close gaps in pharmaceutical research and innovation 18 November 2004 UN News Centre Promoting pharmaceutical innovation by shortening the development process, revamping the payment system and a varied approach to balancing research and market demands, with Europe playing the leading role, are among the findings of a groundbreaking report released by the United Nations health agency today. The World Health Organization (WHO) study =96 Priority Medicines for Europe and the World =96 commissioned by the Dutch Government as current President of the European Union (EU), seeks to close gaps in pharmaceutical research and innovation to best address health needs and emerging threats in Europe and the world. At present, pharmaceutical research and development are based on a market-driven incentive system relying primarily on patents and protected pricing as a prime financing mechanism. As a result, a number of health needs are left unaddressed. =93This report identifies health gaps and potential solutions,=94 WHO Director-General Lee Jong-wook said. =93It is particularly timely for a continent where an ageing population faces increasing health problems, and for a world where old and new threats no longer respect national borders.=94 The study identifies a priority list of medicines for Europe and the rest of the world, taking into account Europe=92s ageing population, the increasing burden of non-communicable illnesses in developing countries and diseases which persist in spite of the availability of effective treatments. It looks at the gaps in research and innovation for these medicines and provides specific policy recommendations on creating incentives and closing those gaps. Among its recommendations are: # Efforts to shorten the medicine development process without compromising patient safety would greatly assist in promoting pharmaceutical innovation through a review of regulatory requirements within the process for relevance, costing, and predictive value. # Health and reimbursement authorities and manufacturers should agree on general principles for the evaluation of future medicines, with a research agenda on the various methods of rewarding clinical performance and linking prices to national income levels. # A varied approach to the issues of research and the market. For instance where the market is strong and the problem is poor understanding of the disease=92s biology, investment in basic research and in facilitating innovation by the pharmaceutical industry will be needed, but where the biology is well understood but the market is weak, public support for bridging the gap between basic and clinical research, possibly through public-private partnerships, will be the preferred solution. From wak22@comcast.net Fri Nov 19 13:13:00 2004 From: wak22@comcast.net (wak22@comcast.net) Date: Fri Nov 19 13:13:00 2004 Subject: [Ip-health] RE: Priority Medicines Report- who implements?? Message-ID: <111920041732.6424.419E2E350009DE86000019182205886014CDCD050E99@comcast.net> -- [ Picked text/plain from multipart/alternative ] Dear Jeff and all: When we (myself and Dr. Richard Laing - as representing the WHO) were commi= ssioned to create a public-health based research and development agenda, w= e were not charged with the task of determining how to implement our recomm= endations as that would go well beyond our original terms of reference. In= my view, implementing even a small portion of our recommendations should n= ot be left just up to the politicians. I hope the recommendations in this r= eport will serve as catalyst for dialogue among ALL (and I mean all...) the= stakeholders, including industry, patient groups, regulators, and reimburs= ement authorities. Warren Kaplan From mpalmedo@cptech.org Fri Nov 19 13:13:09 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Fri Nov 19 13:13:09 2004 Subject: [Ip-health] Reuters: India's Hetero Takes ARVs Off WHO List Message-ID: <419E36EC.3050502@cptech.org> http://www.reuters.co.uk/newsArticle.jhtml?type=healthNews&storyID=6870735§ion=news India's Hetero Takes AIDS Drugs Off WHO List Stephanie Nebehay 19 November, 2004 GENEVA (Reuters) - Hetero Drugs has withdrawn all six of its generic antiretroviral drugs from the WHO's list of approved drugs following concerns about their laboratory tests, the World Health Organization (WHO) said Friday. It was the third time since June that an Indian company has removed anti-AIDS drugs following WHO inspections which revealed faulty bioequivalence tests meant to show the drugs have the same effect as the original patented brands. There are still 48 antiretrovirals on WHO's list of so-called "prequalified" life-extending drugs, both generic and patented, a key weapon in the fight against the global epidemic. It was set up two years ago to guide procurement by aid agencies in Africa and Asia, who say availability of approved low-cost generics is key to extending treatment. "All six drugs on WHO's prequalified list have been withdrawn by them (Hetero)," WHO spokesman Iain Simpson said. "There are certainly major concerns about the lab testing, about the quality of it, about the situation that has been found by these (WHO) inspections," he added. Hetero, which is based in Hyderabad, will redo the studies and hoped to resubmit the results for consideration early next year, according to the WHO spokesman. In a statement, the WHO said that Hetero had acknowledged "deficiencies in the data submitted" and had pledged to hire different contract research organizations (CROs) to carry out fresh testing. "The irregularities found during the CRO inspections do not undermine the proven pharmaceutical quality of the medicines -- including their purity and stability ...," the WHO said. INSPECTIONS Earlier this month Ranbaxy of India pulled its AIDS drugs off the WHO's list after also finding discrepancies in the equivalency tests. It followed the removal by India's Cipla of two HIV/AIDS drugs in June for similar problems. After shortcomings came to light, the United Nations agency last August began routine inspections of contract research organizations, independent labs which do bioequivalence testing, the last stage of the lengthy process of approving a product. "It goes back to inspections not being done routinely in the first place. With perfect hindsight perhaps that should have been done," Simpson said. "But we were following practices of the drug regulatory agencies including the U.S. Food and Drug Administration and the European Drug Regulatory Agency in doing spot checks on CROs." The three Indian drug makers were using different laboratories, according to the WHO spokesman. Lembit Rago, coordinator of quality, safety and efficacy of medicines at WHO, said that the withdrawals showed the need for the inspections so as to ensure better quality treatment. The WHO has launched a campaign to get antiretorivrals to three million people in the developing world by the end of 2005. Only 440,000 of the six million AIDS patients are getting them. The WHO also reiterated that countries should suspend the use of de-listed medicines and switch to other prequalified products. But if these were difficult to obtain immediately, it was recommended patients continue the use of de-listed products. "The risk of withholding treatment is higher than that of providing medicines whose bioequivalence is not proven but which have demonstrated quality and safety," the WHO said. From james.love@cptech.org Fri Nov 19 20:23:01 2004 From: james.love@cptech.org (James Love) Date: Fri Nov 19 20:23:01 2004 Subject: [Ip-health] data exclusivity repealed today by Guatemala Congress Message-ID: <419E9C07.2090509@cptech.org> -------- Original Message -------- Subject: FW: 9-2003 Derogado Date: Fri, 19 Nov 2004 18:27:32 +0000 From: Rosemarie Maldonado Santizo Decree 9-2003 (5 and 10 years exclusivity for a new product) was repealed today by Congress in Guatemala. Lic. Rosemarie Maldonado Santizo. Abogada y Notaria >From: "Luis A. Velasquez Q. CONSULTORIA INTERNACIONAL" > >Reply-To: >To: >Subject: 9-2003 Derogado >Date: Fri, 19 Nov 2004 11:32:04 -0800 > >Estimados amigos: > >Decreto 9-2003 derogado hace minutos, para bien de Guatemala, Latino >Am=E9rica >y el Mundo. > > > >Saludos, > > > >Luis Vel=E1squez > _________________________________________________________________ Express yourself instantly with MSN Messenger! Download today it's FREE! http://messenger.msn.click-url.com/go/onm00200471ave/direct/01/ From bender_dt@adeptscience.co.uk Sat Nov 20 10:42:01 2004 From: bender_dt@adeptscience.co.uk (June Bender) Date: Sat Nov 20 10:42:01 2004 Subject: [Ip-health] Order Rolex or other Swiss watches online Message-ID: Heya, Do you want a rolex watch? In our online store you can buy replicas of Rolex watches. They look and feel exactly like the real thing. - We have 20+ different brands in our selection - Free shipping if you order 5 or more - Save up to 40% compared to the cost of other replicas - Standard Features: - Screw-in crown - Unidirectional turning bezel where appropriate - All the appropriate rolex logos, on crown and dial - Heavy weight Visit us: http://www.icors.com/rep/rolex/ Best regards, Hilton Jones No thanks: http://www.icors.com/z.php From carmelajperezrh@berkshire.nhs.uk Sat Nov 20 10:42:09 2004 From: carmelajperezrh@berkshire.nhs.uk (Carmela J. 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(image)[2] (image)[3] Sat, 20 Nov 2004 05:04:31 +0100 543*793-6567 HWVIYZQGPIMYOE aeolsklavier brotheler asport cellulosity ascitical beaverlike aliunde Anthomyia calcinatory abash azonaphthalene beholdable Alcoran Botryllidae ===References:=== 1. http://adeling.ntvvoodoo.com/?wid=100173 2. http://calpack.ntvvoodoo.com/?wid=100173 3. http://shortformquote.info -- From Sean.HEALY@geneva.msf.org Mon Nov 22 12:21:07 2004 From: Sean.HEALY@geneva.msf.org (Sean.HEALY@geneva.msf.org) Date: Mon Nov 22 12:21:07 2004 Subject: [Ip-health] The Cost of Ideas - in the Economist Message-ID: THE COST OF IDEAS Nov 11th 2004 - The Economist It is becoming ever more apparent that the patent system isn't working INTELLECTUAL property is the cornerstone of the modern knowledge economy. But one of the main forms of intellectual property, the patent--a temporary monopoly designed to provide an incentive to innovate--is increasingly being found wanting, even as the number of applications soars at patent offices around the world. America's patent system has "become sand rather than lubricant in the wheels of American progress", argue Adam Jaffe and Josh Lerner in a new book, "Innovation and its Discontents: How our broken patent system is endangering innovation and progress and what to do about it" (published by Princeton University Press). The world's patent system remains splintered along national lines, yet the system's defects are felt everywhere. "Patent offices are under incredible pressure," says Dominique Guellec, the chief economist at the European Patent Office in Munich. Applications at many patent offices have doubled in the past ten years, and the average length of each submission has increased by 50%. The average quantity of work required to examine an application is three times greater than it was a decade ago. "Of course that can't be neutral in terms of quality," says Mr Guellec. In recent years, the scope of patents has broadened to encompass new technologies, as well as software, and in some instances business methods. Meanwhile, the legal power of patents, once awarded, has increased, and they are more zealously sought. This, combined with an alleged decline in the quality of patents--that is, how accurate their claims are and whether they are truly novel or non-obvious--is deeply troubling, especially as, once awarded, a patent is hard to revoke. PATENTLY ABSURD In America, several controversial business-method patent awards, notably Amazon's one-click payment process, have fuelled the perception that the Patent and Trademark Office (PTO) is under strain. A study by M-CAM, an intellectual-property consultancy, found that over 30% of patents make duplicate claims, raising questions about their validity. America's PTO dismisses the criticism as anecdotal. "We're seeing lots of new industries being born, that is why there are a lot more patent applications," says Mary Critharis of the PTO. The number of patent applications to the PTO is growing at around 6% a year. The wait for a decision is on average 27 months--and much longer for complex applications in advanced sciences. Last year, the PTO received around 350,000 applications and currently has a backlog of over half a million to review. It is a global concern: foreigners account for around half of all patents granted. Similar growth is occurring elsewhere, including in countries that previously showed little interest in intellectual property. Applications to China's patent office increased fivefold from 1991 to 2001. As countries such as China, South Korea and India spend more on research and development, they are filing more patents. The mission creep of America's patent system into more contentious areas is also spreading elsewhere. Later this month, the European Council of Ministers will discuss draft legislation on harmonising policy on computer-implemented innovations. Many small software companies in Europe, as well as "open-source" software developers that make non-proprietary software, oppose the initiative. They fear that it is a first step towards adopting controversial software patents, already awarded in America, which could block different implementations of the same features. Were further proof needed that this may not be an entirely positive development, look no further than the mighty software monopolist, Microsoft, whose chairman, Bill Gates, has called on employees to increase the number of patents that the company files. The rising importance of patents has led both to an arms race and a game of bluff. Many firms in the information-technology and life-sciences industries say they have an incentive to obtain as many patents as possible as bargaining chips in litigation. The patents are used to reach a cross-licensing agreement, usually with some cash thrown in, so that both firms can continue to do business. Those firms that lack patents are thus disadvantaged. Countries increasingly complain to the World Trade Organisation and the United Nations World Intellectual Property Organisation (WIPO) that the patent system discriminates against them. Indeed, WIPO recently adopted a "development agenda" to consider different intellectual-property regimes appropriate to the circumstances of a particular country or region. This was hailed as a boon for reassessing patent protections on drugs and for open-source software. Poor countries have long complained that America is trying to export its tough intellectual-property protections. The growing debate about America's patents is focused on the process of examining applications and the difficulty of challenging dubious patents. Patent examiners typically know less about an invention than the applicant. Moreover, their workload is far higher for rejecting than granting an application. This creates a perverse incentive for examiners to "dispose" of applications by granting rather than rejecting them, argue Messrs Jaffe and Lerner in their new book. To resolve this, they call for a pre-grant notice period when third parties can come forward with "prior art" that would invalidate the patent. As for the second problem, legislation introduced into America's Congress last month seeks to make patent-opposition trials easier for challengers by eliminating some legal hurdles. The legislation would also curb the granting of many forms of business-method patents. As these reforms are debated, the scale and central importance of the patent system are also coming under assault. "The innovation system is broken in that there is too much emphasis on intellectual-property rights," says Suzanne Scotchmer, the author of "Innovation and Incentives" (MIT Press), a book on the role of patents to be published soon. More than ever, she says, inventions that would otherwise go into the public domain because they are funded by taxpayers or charities become "cordoned off" by the patent system. If so, perhaps the patent system not only needs to be repaired, but shrunk? - COPYRIGHT - This e-mail message and Economist articles linked from it are copyright (c) 2004 The Economist Newspaper Group Limited. All rights reserved. http://www.economist.com/help/copy_general.cfm Economist.com privacy policy: http://www.economist.com/about/privacy.cfm From Rachel.COHEN@newyork.msf.org Mon Nov 22 12:21:16 2004 From: Rachel.COHEN@newyork.msf.org (Rachel COHEN) Date: Mon Nov 22 12:21:16 2004 Subject: [Ip-health] Seattle Times Reader's View: Dr. Eric Goemaere (MSF) on generic AIDS drugs Message-ID: This is a multipart message in MIME format. -- [ Picked text/plain from multipart/alternative ] http://seattletimes.nwsource.com/html/opinion/2002096036_satrdr20.html November 20, 2004 The Reader's View Doctors without regrets By Eric Goemaere Special to The Times Collin Levey's assertion that generic AIDS medicines are unsafe and ineffective ("Cheap drugs help no one if they're not effective," Times guest column, Nov. 12) is deliberately misleading. Just like physicians in the U.S., I treat patients with generic medicines every day and would never consider using "inferior" or "untested" drugs, as Levey implies. Using low-priced generic medicines, approved by national drug regulatory authorities where we work, as well as by the World Health Organization (WHO), has allowed Doctors Without Borders to treat more than 23,000 people with HIV/AIDS in 27 countries, including 2,000 here in South Africa. Our clinical results, which parallel those found in the U.S., have been published in peer-reviewed medical journals and presented at international conferences. Most importantly, for my patients and thousands of others, the availability of treatment means that AIDS is no longer an automatic death sentence. It is important to understand that AIDS treatment in South Africa and elsewhere has only been possible because of dramatic drops in the price of antiretrovirals, resulting from generic competition. Four years ago, the price of triple therapy in South Africa was $15,000 per person per year. Today, it is $185. This has created a seismic shift in the willingness and ability of the government to scale up treatment. The fact that several generic AIDS medicines were recently removed from the WHO prequalification list is not evidence that the prequalification process is weak. As the recent recall of Merck's Vioxx shows, regulating brand-name, as well as generic, drugs requires constant vigilance. Unlike Vioxx, the generic AIDS medicines were withdrawn from the WHO list to resolve important questions about the paperwork demonstrating the drugs' bioequivalence ? not because of deadly side effects. There is no doubt that the generic-drug manufacturers whose AIDS medicines were delisted must adhere to strict international standards and submit new data to WHO and drug authorities urgently. But the United States Food and Drug Administration is not the global arbiter of drug quality. If we had waited for the U.S.' stamp of approval, as the Bush administration is requiring in the President's Emergency Plan for AIDS Relief, thousands of lives would have been needlessly lost. People with HIV/AIDS in South Africa and throughout the continent continue to fight hard for access to affordable medicines. This is no "Western spitball contest over drugs, pricing and intellectual property rights." For our patients, and for millions of people with HIV/AIDS in developing countries, it is a matter of life and death. Dr. Eric Goemaere is head of mission for Doctors Without Borders (M=E9decin= s Sans Fronti=E8res) in Khayelitsha, South Africa. --- Rachel M. Cohen U.S. Director, Campaign for Access to Essential Medicines Doctors Without Borders/M=E9decins Sans Fronti=E8res (MSF) 333 Seventh Avenue, 2nd Floor * New York, NY * 10001-5004 * USA Tel: +1-212-655-3762 Mobile: +1-917-331-9077 Fax: +1-212-679-7016 E-mail: rachel.cohen@newyork.msf.org http://www.doctorswithoutborders.org/ http://www.accessmed-msf.org/ From zackie@pixie.co.za Tue Nov 23 11:58:01 2004 From: zackie@pixie.co.za (Zackie Achmat) Date: Tue Nov 23 11:58:01 2004 Subject: [Ip-health] TAC Statements on Traditional Healers, THO Demonstrations and Matthias Rath Message-ID: This is a multi-part message in MIME format. -- [ Picked text/plain from multipart/alternative ] Today's electronic newsletter deals with the Traditional Healers' Organisation's/Rath Foundation demonstrations against the TAC. 23 November 2004 Contents * TAC statement on THO March to TAC offices in Cape Town and Johannesburg * TAC exposes profiteer Matthias Rath * Minister of Health blocks the Medicines Control Council from litigating against Matthias Rath * Text extracts of THO/Rath statements defaming the TAC TAC Supports Traditional Healers TAC calls for investment into and regulation of traditional medicine On 23 November the Traditional Healers' Organisation (THO) and the Dr Rath Foundation will demonstrate outside TAC offices in Cape Town and Johannesburg. The THO and Rath complain that TAC only promotes antiretrovirals for HIV/AIDS treatment and that TAC ignores traditional medicines and nutrition. The TAC says this is not true. The TAC recognises the role of traditional healers in caring for both the psychological and physical well-being of many people in South Africa. We also believe that nutrition is central to HIV/AIDS care. TAC supports the following campaigns for traditional healers: * The TAC believes that there are traditional medicines that work but proof of their safety and efficacy requires scientific data. Therefore we applaud the efforts by the Medical Research Council Traditional Medicines Research Unit and government to research traditional medicines. The TAC supports the call by traditional-healers for more investment into researching traditional medicines. * Many people use traditional medicines, but they continue to die of AIDS. This shows why it is important to invest more money into researching traditional medicines so that safe and effective treatments can be identified, and that medicines that harm people can be withdrawn. It also shows that traditional healers should be trained about the latest science and treatment of HIV/AIDS so they can advise their patients better. * Pharmaceutical companies that use traditional medicines in their products must compensate the communities that developed them. Intellectual property protection for traditional medicines is necessary so that communities and traditional healers benefit from money made through the sale of pharmaceutical products that contain traditional medicines. * The implementation of government's Operational Plan for Comprehensive HIV and AIDS Care, Management and Treatment for South Africa will be more successful if traditional healers are part of it. This would mean providing training to traditional healers on the science, prevention, treatment and care of HIV/AIDS. The THO has made inaccurate allegations against the TAC which we correct here: * The TAC is independent of the pharmaceutical industry and receives no funding from them (See details of TAC's finances at http://www.tac.org.za/Documents/FinancialDocs.htm). We are frequently in conflict with pharmaceutical companies. Our finances are open for public scrutiny and a model of good governance. We challenge Rath and the THO to produce any evidence that improperly links TAC to any drug company. Our sources of funding and our audited statements are on our website for all to see. We demand that THO and Dr. Rath declare all their sources of funding and how they spend it. * The TAC does not ignore the side-effects of antiretroviral medicines. Side-effects are discussed in detail at our workshops and in our pamphlets and booklets on antiretrovirals. We use these medicines and it is in our interest to ensure that side-effects are detected and managed. * The TAC does not ignore nutrition, but considers it a vital part of the management of HIV. This is why we have published widely distributed fact sheets on nutrition and why nutrition is a topic of our treatment literacy workshops (see http://www.tac.org.za/Documents/Literacy/nutrition_fact_sheet.pdf). We demand that government provides food parcels to every person who needs them. But, nutrition is not enough for people with AIDS. * The TAC does not campaign only for antiretroviral medicines. We support the use of any medicine that has been demonstrated in scientific tests to be safe and effective for treating HIV opportunistic infections, including cotrimoxazole, acyclovir, fluconazole and many others. We have supported government legislation to make all medicines more affordable. * The TAC is not aware of a single occasion where an official TAC spokesperson or communication has dismissed traditional medicine without examining the evidence, as the THO alleges. * The THO accuses the TAC of not promoting traditional medicines because we have not researched them. We have asked the THO before for scientific information on safe and effective traditional medicines but have received nothing. In fact, TAC paid for a joint workshop held in Gauteng with the THO. The THO leaders say they are the country's largest representative of traditional healers. They are therefore primarily responsible for providing accurate, evidence-based information on traditional medicines to the TAC and the public. We believe these are areas of disagreement between the TAC and the THO: * While TAC supports traditional healers, many people are being exploited by some unethical traditional healers who claim to have cures for AIDS. * Only medicines which have been shown to be safe and effective using scientific tests should be promoted. In South Africa, the Medicines Control Council (MCC) is responsible for determining which medicines are safe and effective. * Traditional healers should be regulated as with other health professions. This is to protect consumers from some traditional healers who act unethically. It is also necessary to protect the reputation and practices of traditional healers. * The distinction between "western medicines" and "traditional medicines" is wrong and racist. The science of medicine has been developed by communities all over the world. We should only judge medicines by whether they have been scientifically tested or not. * The public interest and law require that any product that makes any health claim should demonstrate safety, efficacy and quality. This applies to everyone who sells "treatments", "cures" and "medicines". We ask the THO to answer the following questions: 1. Which traditional medicines have been shown to be safe and effective for treating HIV/AIDS? 2. What is the THO doing to inform the public about these medicines as well as their correct use? 3. Will the THO publish a list of all herbs and compounds that it recommends for every illness with the evidence of safety and efficacy? 4. What is the THO's policy for dealing with traditional healers who act unethically? 5. Why is the THO's march being supported by people such as Anthony Brink who deny that HIV causes AIDS? TAC wants to work with traditional healers The TAC is saddened that THO leaders have chosen to march against us. We call for traditional healers from all organisations including THO to work together and genuinely promote responsible use of traditional medicines. We warn that Dr Rath has financial interests in selling his own products. He has been stopped from advertising them in England because he makes false claims. Now he may be trying to sell his unproven and possibly dangerous medicines to poor people in poor countries. South Africa is reforming its health-care system; traditional healers must not be left out. But, alliances with companies like that of the Rath Foundation will discredit and divide traditional healers. [END OF STATEMENT ON THO MARCH - BACK TO CONTENTS] Warning: Who is Dr. Matthias Rath and what is he selling? Dr. Matthias Rath has recently begun working with the Traditional Healers' Organisation to mislead the public on HIV/AIDS and the work of the Treatment Action Campaign. * Dr. Rath promotes himself as free from interests in the pharmaceutical industry, but he owns a pharmaceutical company that sells vitamin products. He is the founder, Managing Director and President of Matthias Rath Inc. Dr. Rath should be asked for full information on his profits, sales and products. * Dr Rath promotes himself as someone who sells natural remedies as opposed to the synthetic medicines of pharmaceutical companies. He attacks the unethical behaviour of pharmaceutical companies. But his products are also synthetic as with any other pharmaceutical product. His pharmaceutical company is worse than other pharmaceutical companies because it ignores the laws for testing and advertising medicines. * Dr. Rath claims to campaign against pharmaceutical company profiteering and their patents, but he owns at least five patents in the United States! (Patents: 6693129, 6686340, 5650418, 5278189, 5230996 - thank you to Bukopharma, an organisation based in Germany that monitors pharmaceutical companies, for supplying this.) * The Medicines Control Council (MCC) is the organisation tasked with approving medicines that have been tested and found to be safe and effective. We ask why does Dr. Rath not want his products to be tested by the MCC? * The British Advertising Standards Authority has forced Dr. Rath to remove his advertising for treatments as they were unsupported by evidence and misled the public. See: http://www.asa.org.uk/adjudications/show_adjudication.asp?adjudication_id=3 0238&from_index=by_sector&dates_of_adjudications_id=all * Dr Rath's products are not allowed to be sold in Switzerland. They are not approved as medicines or nutritional supplements. See: http://www.quackwatch.org/11Ind/rath.html * The Food and Drug Administration in the USA has cautioned Dr. Rath for advertising certain of his products in contravention of US law. Dr. Rath claims they have health benefits which means they should be classified as medicines, but no evidence of their safety or effectiveness has been provided. See: http://www.fda.gov/cder/warn/cyber/2002/CFSANvitacor.htm * Because he is not allowed to promote his products in the US, UK, Germany and Switzerland, Dr Rath may now be trying to sell his products to poor people in poor countries. He has recently started to advertise in South African newspapers. * Dr Rath's company website advertises a range of products. Despite his claims that these products cure or prevent many diseases, the adverts include the disclaimer that "This product is not intended to diagnose, treat, cure or prevent any disease." * The prices of the products from Matthias Rath Ltd are extortionate. His basic vitamin tablets cost $29.95 per month - equivalent to R180 per month. The more expensive combinations of tablets can cost people up to R3,500 per month. Dr Rath's interest is in making money from unproven and possibly dangerous products, not helping people as he claims. * Some of the pills produced by Matthias Rath Ltd contain quantities of vitamins which are three times over the recommended daily intake. He sells doses so large that they are illegal in Germany. * Dr Matthias Rath is an AIDS Denialist. Dr Rath rejects the overwhelming evidence that HIV causes AIDS. He also states that the primary cause of heart attacks, strokes, cancer and other diseases is a lack of vitamins. He appears not to recognise the role of the other 300+ accepted factors linked to these diseases. * Dr Rath claims that "Our research has shown that a combination of vitamin C with the natural amino acids lysine, proline, and specific extracts from green tea can block the invasion of cancer cells" ( www.stopping-cancer-naturally.org ). However, the Swiss Study Group for Complementary and Alternative Methods in Cancer, have found no proof that any of Dr Rath's products have any impact upon human cancer. We all want cures for the diseases that afflict us. Even though medical science has improved tremendously over the last few hundred years, there are still many unanswered questions. There are seldom quick and easy solutions. Dr. Rath is taking advantage of people with real problems and offering them quick and easy fixes which are expensive and do not work. We urge you not to be deceived by him. [END OF STATEMENT ON RATH - BACK TO CONTENTS] Minister of Health blocks MCC from litigating against Matthias Rath In recent months, Dr. Matthias Rath has run a series of libelous attack advertisements on the South African Medicines Control Council in the Mail & Guardian. Rath accuses the MCC of being in the pockets of drug companies. The TAC has learnt that the Minister of Health blocked the MCC from litigating against Rath for defamation. We therefore ask the Minister of Health: 1. Why are you protecting Matthias Rath? 2. Why have you not come to the defence of the MCC? 3. Matthias Rath has on a number of occasions stated that he supports you. Are you prepared to distance yourself publicly from Matthias Rath and his theories? [END OF STATEMENT ON MINISTER OF HEALTH AND RATH - BACK TO CONTENTS] Extracts of text from THO statements and pamphlets We reprint below extracts from THO statements and pamphlets released in the last few days which demonstrate the false allegations they have made against the TAC. "On Wednesday the 17th of November 2004 the Traditional Healers Organization (THO) and the Dr. Rath Health Foundation announced in a joint press statement that they stand united against the "profit over people strategy" of the pharmaceutical investment business with disease in South Africa." "The THO, the largest Traditional Healer formation in the country and a member organization of the pharmaceutically connected TAC, will Picket the Treatment Action Campaign's (TAC's) Gauteng Provincial Office and the National Office in Cape Town simultaneously on Tuesday the 23rd of November 2004." "This is an opportune time for these pickets as it coincides with the sixteen days of activism on violence against women and children. It is mainly women and children who are affected by HIV/AIDS and that are being abused by the lack of information on African Traditional Medicines and other treatment options, not to mention being given drugs like AZT and Nevirapin that have devastating side effects. There is nothing more violent than giving an innocent child, who has no choice, deadly drug that impact on their long term health." "The reason for the picket is that we believe the general public should be fully informed about the deadly side effects of anti-retroviral (ARVs) treatments which the TAC, pharmaceutical companies and the media tend to ignore or down play the major side effects and the stringent compliance issues. We are also picketing to let them know that they should promote information on all forms of treatments, not just ARVs. They must stop misinforming the public about the safety and efficacy issues in relation to African Traditional Medicines (ATMs), Complementary Medicines (CMs), supplements and good nutrition. Numerous times the TAC, pharmaceutical companies and the media slander and ridicule ATMs, CMs, supplements and nutrition without reason, their statements are totally unfounded. When they are informed about research evidence they denounce the evidence without even looking at any of the materials. This must stop and people must be fully informed so as to make the best decision for their own health, whether it be the choice to use ARVs, TMs, CMs, supplements or good nutrition solely or in combination, that is the individual's choice." "The TAC and PMA have ridiculed Traditional Medicine and Traditional Health Practitioners consistently without basis for too long. To attempt to put down those people who advocate for ATM, CMs, supplements and nutrition by calling them 'quacks' and the like is a true indication of disrespect and bears testimony to the fact that the TAC and the PMA do not take Traditional Medicines and the profession seriously. They only use Traditional Health Practitioners as stooges to promote their own agenda, stealing valuable Indigenous Knowledge (IK), which is used as the basis for making western drugs where they isolate and synthesise these natural substances. None of the knowledge that is stolen from Traditional Healers globally is ever acknowledged and the pharmaceutical cartels make a fortune off the backs of Traditional Health Practitioners by making synthetic drugs with massive side effects. The original natural products in 99.9% of cases when used correctly do not have side effects. It is amazing that the pharmaceutical industry and the TAC can continue to ridicule ATMs, other CMs, supplements and good nutrition when more than 60% of western drugs are based on natural traditional medicines. We ask why western medicine bases their drugs on Traditional Medicines if they are not effective? The only reason pharmaceutical companies synthesise these Traditional Medicines is for patenting reasons so they can make a fortune in royalties from IK, as natural products are not able to be patented." "This nation currently faces an unprecedented attack from two sides on the rights of our people to have free access to life saving natural and Traditional Medicines: "1.The Treatment Action Campaign (TAC) has been financially groomed by the Rockefeller Foundation, which holds shares in over 200 pharmaceutical corporations. The Rockefeller family was historically the driving force behind the creation of what is known today as the pharmceutical investment business. A major part of this years funding comes from the Atlantic Philantrophies, where a member of the board of directors is the financial advisor of the Rockefeller family. Accordingly TAC tries to silence all critics of the devastating side effects and ineffectivesness of AIDS Drugs (ARVs) and promoters of non-toxic natural treatments such as ATMs and essential nutrients. With their budget of R18 million this year, the TAC conducts massive public campaigns to coerce the South African government into distributing these toxic pharmaceutical drugs to the most vulnerable parts of its population. Sadly, most low-ranking members and supporters of the TAC are completely unaware that the organisation has been directed to advance the financial interests of the pharmaceutical business with disease. With two out of three drugs on the world market produced under patent protection in the US and the UK alone, the health care systems of the 200 countries of the world are being held hostage in this new form or Pharmaceutical Colonialism. "2.In order to ensure futher billion-rand profits from the sale of patented synthethic drugs the pharmaceutical industry is abusing its financial influence over the Medicines Control Council (MCC) to ban all natural and traditional therapies in South Africa. The MCC proposed recently to put all natural therapies under a pharmaceutical regulatory control system that will effectively outlaw all natural options to the toxic, mostly ineffective but extremely profitable, synthetic drugs of the pharmaceutical industry. This ban would make traditional and natural medicine inaccessible to those most in need in Sout Africa, namely the poor and black population. MCC's decision making external consultants are supposed to protect the people from dangerous pharmaceutical. Unbeknown to the public and government these people who have only the interests of the industry in mind, not the health of the people. In fear of a public lawsuit that might reveal the full extent of this scandal the MCC no longer challenges public statements by the Dr. Rath Health Foundation that all of its decision-making members are directly or indirectly on the payroll of the pharmaceutical industry." "The THO supports the enlightened position of the South African government toward African Traditonal Medicines and natural therapies. However, we see these nobel efforts being sabotaged by unaccountable individuals and institutions at lower levels who refuse or are not willing to implement the government policies for the people." "We DEMAND: ... The TAC disclose all their indirect financial connections with pharmaceutical investment groups; and that they be disbanded to be substituted by a truly independent organisation that fulfills the TAC Constiution and informes the South African public comprehensively about the full story on all forms of treatment options - ATMs, CMs, supplements, good nutrition and ARVs. A formal investigation into the MCC's decision-making members' financial conflict of interests, to root out the drug industry's influence once and for all." "The TAC ... be disbanded" "Dr. Matthias Rath is the world renowned researcher for natural health therapies who led the scientific breakthrough against cardiovascular disease, cancer and viral diseases by natural means. He is the founder of the Dr. Rath Health Foundation that is leading the worldwide struggle against the interests of the pharmaceutical investment business with disease and for free access to life saving natural therapies. With his campaign "Break the Chains of Pharmaceutical Colonialism", the Dr. Rath Health Foundation supports the fight of the South African people and the government to make effective and affordable natural health a reality for all." "More than 60% of western medicines are based on Traditional Medicines. Traditional Healers from around the globe benefit nothing from this while pharmaceutical companies make billions of dollars and these medicines are not as effective as the natural product that were modeled from - a Traditional Medicine. Scientists and Pharmacists take the natural product, isolate a certain ingredient and make a synthetic (not natural) version of the active ingredient. Then they state that Traditional Medicines do not work. They steal the information, make money, then slander Traditional Medicines and misrepresent them by talking of side effects and the like. "The fact is Traditional Medicines are not the ones with the side effects. It is the process of isolating one ingredient that causes the side effects. Scientists do not realise that God made the plants as a whole with all ingredients having their purpose. The so called 'active ingredient' may be the one that treats a particular illness but the other substances are necessary to balance that ingredient and prevent side effects." "The TAC should leave the government to do its work." "The government had justifiable concerns about the ARV rollout being unsure of the full benefits of ARVs weighed against the severe side effects; they are concerned about the long term health of the nation, not band-aid tactics that worsen the severity of the situation in the end. The concerns are correct and structures still are not in place and the people and medical staff are not informed about the compliance issues and side effects. "The TAC must stop these intimidatory tactics toward the government. These tactics only assist the pharmaceutical cartels and definitely not the people of South Africa. The government is attempting to ensure that the people of South Africa are fully aware of all aspects of ARV treatment and that all necessary processes are in place to guarantee appropriate access to treatment, information and food are available first and foremost. "The TAC forced the government to implement the rollout of ARV before staff were trained, food guaranteed, an assurance that government could prvide enough ARVs and full information given to the general public in relation to the drastic side effects of ARVs." [END OF EXTRACTS OF THO STATEMENTS - BACK TO CONTENTS] [END OF NEWSLETTER] -- From mpalmedo@cptech.org Tue Nov 23 11:58:11 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Tue Nov 23 11:58:11 2004 Subject: [Ip-health] AFP: France to introduce legislation for generic exports Message-ID: <41A36A13.5040908@cptech.org> http://www.expatica.com/source/site_article.asp?subchannel_id=58&story_id=14233&name=France+to+apply+WTO+generic+drug+pact+by+2005 France to apply WTO generic drug pact by 2005 DAKAR, Nov 22 (AFP) - French Health Minister Philippe Douste-Blazy said Monday that France will by early next year implement a World Trade Organisation pact to make generic drugs more accessible to poor countries. "The bill is ready and we will be able to submit it to parliament in January," Douste-Blazy told reporters Monday during a day-long visit to Senegal. "What we need is for other European countries to follow us," he added, pointing to Spain which has said it would also develop its own version of the pact. The WTO reached a deal in 2003 aimed at giving developing countries access to essential medicines they would not normally be able to afford. So far, only Canada and Norway have passed the bill, which grants "obligatory licences" to generic pharmaceutical companies so they can meet demand from poorer countries for drugs they do not have the capacity to produce themselves. The European Commission in October proposed a licensing system to make it easier for European generic drug makers to treat killer diseases such as AIDS, malaria and tuberculosis that would also contain specifics on labelling and packaging of cut-price drugs to prevent their re-importation to the west. Douste-Blazy also told President Abdoulaye Wade that France would help its former west African colony to build a laboratory to manufacture its own generic drugs, the Senegalese Press Agency reported. From james.love@cptech.org Tue Nov 23 13:06:01 2004 From: james.love@cptech.org (James Love) Date: Tue Nov 23 13:06:01 2004 Subject: [Ip-health] Drug Companies Look to China For Cheap R&D: WSJ Message-ID: <41A36D57.3070602@cptech.org> Drug Companies Look to China For Cheap R&D *By LAURA SANTINI **Staff Reporter of THE **WALL STREET** JOURNAL** **/November 22, 2004/**/; Page B1/* SHANGHAI -- Long known as a place to produce clothes and toys cheaply, China now is providing the West with another opportunity: developing drugs at lower cost. Opening a new frontier in outsourcing, pharmaceutical companies overwhelmed by the rising cost of creating drugs are turning to China to conduct research and development. They are finding highly educated scientists who work for a fraction of what their Western counterparts are paid, as well as vibrant and growing biotechnology businesses. And they are beginning to sink significant amounts of money into deals that will further boost China's capabilities. "We see the rapid emergence of a Chinese biotech industry," says Daniel Vasella, chief executive of Novartis AG, a Swiss drug maker that recently formed a partnership with the government-run Shanghai Institute for Materia Medica. Scientists there will identify compounds derived from traditional Chinese medicine that Novartis scientists may be able to develop into new drugs. This month, Roche Ltd. of Switzerland unveiled a research-and-development center on the outskirts of Shanghai, where the drug giant will employ 40 local scientists. Pfizer Inc. of New York is spending $175 million on establishing a new regional headquarters in Shanghai. Although the office will oversee existing manufacturing and marketing operations, Pfizer said last month it also is considering building its own R&D center in China. With the expense of bringing a new drug to market now sometimes topping $1 billion, big pharmaceutical companies are increasingly searching for a low-cost edge. Drug companies have found that China, where doctorate-level scientists command $25,000 a year, compared with nearly 10 times that in the West, makes a good place to test drug compounds and their efficacy. While some other highly complex R&D -- such as intricate biological testing -- still is mainly performed in the West, China can save companies money, since about 80% of their total R&D costs go toward scientists' salaries. [Takeout]The savings for the drug-industry giants comes amid increasing pressure on them to expand their pipeline of potential blockbusters. "Doing research in a low-cost setting should allow drug companies to deploy the dollars" they spend in the U.S. and Europe more effectively, says Drew Senyei, a health-care venture capitalist at Enterprise Partners. Despite lower research-and-development costs, however, companies so far aren't planning any corresponding drug price cuts. At Roche's new Shanghai operation, scientists will focus on "medical chemistry," screening various compounds that have shown promise as possible antiviral or cancer treatments. The group will have access to research conducted at the drug giant's other research centers in Basel, Switzerland, and Nutley, N.J., and it will share its findings with scientists in those laboratories. Roche executives say they didn't build their $11 million facility simply to save money. "There is very good chemistry done in China," says Jonathan Knowles, the company's global head of research, with many Chinese scientists on the same educational footing as their U.S. counterparts. The laboratory also should help Roche establish strong ties with Chinese authorities, something that could prove valuable as the company seeks to expand operations in China, as well as explore new market opportunities there. Yet conducting research and development start to finish in China remains years away for the industry's big players. Lingering discomfort with the country's level of protection of intellectual property remains a problem, drug industry executives say. Also, scientists still require training in the West to gain understanding of cutting-edge techniques and equipment. In the past, Novartis has trained Chinese scientists at the company's Basel, Switzerland, headquarters and then transferred them back to China to continue research efforts. The labor-intensive screening process for potential new drugs involves testing how a biological target, such as a protein or gene, responds to certain compounds and repeating the process hundreds of times to make sure it is a uniform response. Some companies have broadened their R&D operations to include clinical trials in China, where patient enrollment is easier and associated hospital fees much lower. It isn't just the industry's giants that are being lured to China; Western start-up businesses are moving here as well. The lower costs buy them more time to prove the viability of their drug prospects between rounds of funding from Western venture capitalists. Germany's Mologen Inc., for example, is collaborating with Starvax Inc. of Beijing on a colon cancer drug now undergoing clinical trials in Europe. Rather than spending on expanded research and development in Europe, Mologen is having Starvax carry out R&D to determine whether the compound might be effective in treating other types of cancer. TargeGen of San Diego, for instance, is developing small-molecule drugs for treating cardiovascular disease, but it has shifted chemical screening of various compounds to Shanghai's WuXi PharmaTech Co. "We pay WuXi to do research on our compounds and then use the results for further development" in the U.S., says Enterprise Partners' Drew Senyei, a venture-capitalist investor in TargeGen. Mr. Senyei says he would like to replicate that arrangement at some point with another U.S. biotechnology company trying to develop cancer treatments. Through companies such as WuXi, Western drug companies soon will be able to conduct complex animal testing in China, another vital research tool that is used to find out whether a compound is safe, not just whether it fights disease. WuXi, for instance, has an empty building it plans to use for animal testing on a contract basis by mid-2005. For biotechnology companies whose research projects have stalled or whose cash has run dry, showing positive results in China can persuade venture capitalists to give them more capital. Starvax is typical of a new breed of Chinese biotechnology companies run by entrepreneurial Chinese returnees. It was started in July by two former classmates at Peking University, Yiyou Chen, 33 years old, and Justin Chen, 34. The like-named friends both spent more than a decade in the U.S. earning graduate degrees and working, respectively, as a scientist and a patent lawyer. Yiyou Chen previously worked on developing vaccines for viruses that cause cervical cancer and hepatitis B at Genencor International Inc. of Palo Alto, Calif. Now Starvax is working on discovering vaccines in the same areas. Another Chinese upstart is moving beyond simply offering research for hire. Crimson Pharmaceutical in Shanghai plans to license Asian sales rights from its Western partners and conduct its own development studies to create proprietary products. Chinese drug companies are eager to secure such exclusive deals. Patent protection, of course, remains an issue. But with China now a member of the World Trade Organization, some of those concerns are abating. Kenneth Chien, director of the Institute of Molecular Medicine at the University of California, San Diego, believes a homegrown biotechnology industry in China will spur progress in intellectual-property protection. Scientists trained in the U.S. generally should have greater understanding of patent rights, he says, and local companies will begin to demand regulatory cover for their breakthroughs. "Without IP [intellectual property] protection, you have no industry," Mr. Chien says. So far, Crimson has purchased the rights to four compounds aimed at treating HIV developed by Octamer Inc. of Tiburon, Calif. Chief scientist Sam Lou says Crimson hopes to gain regulatory approval for the drugs and then re-license them to a Chinese pharmaceutical company with sales and marketing muscle. Both Crimson and Starvax got off the ground with just $2 million in seed financing, a pittance compared with the tens of millions of dollars often needed in the U.S. Although it remains unclear which Chinese start-up businesses will hit the jackpot and which will go under, Western scientists see the burgeoning industry as a positive for drug development. Johnson & Johnson and Pfizer, for instance, recently visited the "incubator building" in Beijing's Life Sciences Park, where Starvax is located, to find out what the new biotechnology companies are doing. Mr. Vasella, Novartis' chief executive, observes that Chinese biotechnology companies are rapidly adopting Western research standards and knowledge. "It is only a matter of time before China catches up," he says. *Write to* Laura Santini at laura.santini@wsj.com From pedro_paranagua@yahoo.com.br Wed Nov 24 09:58:01 2004 From: pedro_paranagua@yahoo.com.br (=?windows-1252?Q?Pedro_de_Paranagu=E1_Moniz?=) Date: Wed Nov 24 09:58:01 2004 Subject: [Ip-health] IP on the Financial Times Message-ID: <41A3D281.8050103@yahoo.com.br> Dear moderator, please authorise. If, however, you find it more appropriate to post on the e-commerce list, please do so. Regards, Pedro de Paranagua Moniz Masters in Law (LL.M.) candidate of 2004/2005 class Queen Mary, University of London ***************************************************** James Boyle: A natural experiment By James Boyle Published: November 22 2004 17:34 | Last updated: November 22 2004 17:34 Imagine a process of reviewing prescription drugs which goes like this: representatives from the drug company come to the regulators and argue that their drug works well and should be approved. They have no evidence of this beyond a few anecdotes about people who want to take it and perhaps some very simple models of how the drug might affect the human body. The drug is approved. No trials, no empirical evidence of any kind, no follow-up. Or imagine a process of making environmental regulations in which there were no data, and no attempts to gather data, about the effects of the particular pollutants being studied. Even the harshest critics of drug regulation or environmental regulation would admit we generally do better than this. But this is often the way we make intellectual property policy. So how do we decide the ground-rules of the information age? Representatives of interested industries come to regulators and ask for another heaping slice of monopoly rent in the form of an intellectual property right. They have doom-laden predictions, they have anecdotes, carefully selected to pluck the heartstrings of legislators, they have celebrities who testify - often incoherently, but with palpable charisma - and they have very, very simple economic models. The basic economic model here is =93If you give me a larger right, I will have a larger incentive to innovate. Thus the bigger the rights, the more innovation we will get. Right?=94 Well, not exactly. Even without data, the models are obviously flawed - copyrighting the alphabet will not produce more books, patenting E=3DMC2 will not yield more scientific innovation. Intellectual property creates barriers to, as well as incentives towards, innovation. Clearly the =93more is better=94 argument has limits. Extensions of rights can help or hurt, but without economic evidence beforehand and review afterwards, we will never know. In the absence of evidence on either side, the presumption should obviously still be against creating a new legalised monopoly, but still the empirical emptiness of the debates is frustrating. This makes the occasion where there actually is some evidence a time for celebration. What we really need is a test case where one country adopts the proposed new intellectual property right and another does not, and we can assess how they are both doing after a number of years. There is such a case. It is the =93database right.=94 Europe adopted a Database Directive in 1996 which both gave a high level of copyright protection to databases, and conferred a new =93sui generis=94 database right even on unoriginal compilations of facts. In the United States, by contrast, in a 1991 case called Feist, the Supreme Court made it clear that unoriginal compilations of facts are not copyrightable. (The case is not as revolutionary as it is claimed to be. Most of the appeals courts in the United States had long held this to be the case. In fact, a tenet of the US intellectual property system is that neither facts nor ideas can be owned.) Since 1991 the U.S. Congress has managed to resist frenzied attempts by a few database companies to create a special database right over facts. Interestingly, apart from academics, scientists and civil libertarians, many database companies, and even those well-known communist property-haters, the U.S. Chamber of Commerce, oppose the creation of such a right. They believe that database providers can adequately protect themselves with contracts, technical means such as passwords, can rely on providing tied services and so on. Moreover, they argue that strong database protection may make it harder to generate databases in the first place; the facts you need may be locked up. The pressure to create a new right continues, however, aided by the cries that US must =93harmonise=94 with Europe. So here we hav= e our natural experiment. Presumably the government economists are hard at work both in the US and the EU, seeing if the right actually worked? Umm.... No. Despite the fact that the European Commission has a legal obligation to review the Database Directive for its effects on competition (they are three years late in issuing their report) no attention appears to be being paid to the actual evidence of whether the Directive helps or hurts in the EU, or whether the database industry in the US has collapsed or flourished. That is a shame, because the evidence is there, and it is fairly shocking. Intellectual property rights are a form of state-created monopoly and =93the general tendency of monopolies,=94 as Macaulay pointed out, is to =93make things dear, to make them scarce, and to make them bad.=94 Monopolies are an evil, but they must sometimes be accepted when they are necessary to the production of some good, some particular social goal. In this case, the =93evil=94 is obviously going to be an increase in price of databases, and the legal ability to exclude competitors from their use =96 that, after all is the point of granting the new right. The =93good=94 is that we are supposed to get lots of new databases, databases that we would not have had but for the existence of the database right. If the database right were working, we would expect positive answers to three crucial questions. First, has the European database industry=92s rate of growth increased since 1996, while the US database industry has languished? (The drop off in the US database industry ought to be particularly severe after 1991 if the proponents of database protection are correct; they argued the Feist case was a change in current law and a great surprise to the industry.) "Despite the fact that the European Commission has a legal obligation to review the Database Directive for its effects on competition (they are three years late in issuing their report) no attention appears to be being paid to the actual evidence of whether the Directive helps or hurts in the EU" Second, are the principal beneficiaries of the database right in Europe producing databases they would not have produced otherwise? Obviously if a society is handing over a database right for a database that would have been created anyway, it is overpaying - needlessly increasing prices for consumers and burdens for competitors. This goes to the design of the right - has it been crafted too broadly, so that it is not being targeted to those areas where it is needed to encourage innovation? Third, and this one is harder to judge, is the right promoting innovation and competition rather than stifling it? For example, if the existence of the right allowed a one-time surge of newcomers to the market who then to use their rights to discourage new entrants, or if we promoted some increase in databases but made scientific aggregation of large amounts of data harder overall, then the database right might actually be stifling the innovation it is designed to foment. Those are the three questions that any review of the Database Directive must answer. But we have preliminary answers to those three questions and they are either strongly negative or extremely doubtful. Are database rights necessary for a thriving database industry? The answer is a clear =93no.=94 In the United States, the database industry has grown more than 25-fold since 1979 and - contrary to those who paint the Feist case as a revolution - for that entire period, in most of the United States, it was clear that unoriginal databases were not covered by copyright. The figures are even more interesting in the legal database market. The two major proponents of database protection in the United States are Reed Elsevier, the owner of Lexis, and Thomson Publishing, the owner of Westlaw. Fascinatingly, both companies made their key acquisitions in the US legal database market after the Feist decision, at which point no one could have thought unoriginal databases were copyrightable. This seems to be some evidence that they believe they could make money even without a database right. How? In the old-fashioned way: competing on features, accuracy, tied services, making users pay for entry to the database and so on. If those companies believed there were profits to be made, they were right. Jason Gelman, one of our students, points out in a recent paper that Thomson=92s Legal Regulatory division had a profit margin of over 26% for the first quarter of 2004. Reed Elsevier=92s 2003 profit margin for LexisNexis was 22.8%. Both profit margins were significantly higher than the company average and both are earned primarily in the $6 billion US legal database market, a market which is thriving without strong intellectual property protection over databases. (First rule of thumb for regulators: when someone with a profit margin over 20% asks you for additional monopoly protection, pause before agreeing.) What about Europe? There is some good news for the proponents of database protection. As Hugenholtz, Maurer, and Onsrud point out in a nice article in Science Magazine, there was a sharp, one-time spike in numbers of companies entering the European database market immediately following the implementation of the Directive in member states. Yet their work, and =93Across Two Worlds,=94 a fascinating study by Maurer, suggests that the rate of entry then falls back to levels similar to those before the Directive. Maurer=92s analysis shows that the attrition rate is also very high in some European markets in the period following the passage of the Directive - even with the new right, many companies drop out. At the end of the day, the British database industry - the strongest performer in Europe - adds about 200 databases in the three years immediately after the implementation of the Directive. In France there is little net change in the number of databases and the number of providers falls sharply. In Germany, the industry added nearly 300 databases immediately following the Directive - a remarkable surge - about 200 of which rapidly disappeared. During the same period the US industry adds about 900 databases. Bottom line? Europe=92s industry did get a one-time boost, and some of those firms have stayed in the market; that is a benefit, though a costly one. But database growth rates have gone back to pre-Directive levels, while the anti-competitive costs of database protection are now a permanent fixture of the European landscape. The US, by contrast, gets a nice steady growth rate in databases without paying the monopoly cost. (Second rule of thumb for regulators: Do no harm! Do not create rights without strong evidence that the incentive effect is worth the anti-competitive cost.) Now the second question. Is the Database Directive encouraging the production of databases we would not have got otherwise? Here the evidence is clear and disturbing. Again, Hugenholtz et al, point out that the majority of cases brought under the Directive have been about databases that would have been created anyway - telephone numbers, television schedules, concert times. A review of more recent cases reveals the same pattern. These databases are inevitably generated by the operation of the business in question and cannot be independently compiled by a competitor. The database right simply serves to limit competition in the provision of the information. Last week, the European Court of Justice implicitly underscored this point in a series of cases concerning football scores, horse-racing results and so on. Rejecting a stunningly protectionist and one-sided opinion from its Advocate General, the court ruled that the mere running of a business which generates data does not count as =93substantial investment=94 enough to trigger the database right. It would be nice to think that this is the beginning of some scepticism about the reach of the Directive, scepticism that might even penetrate the Commission=92s review of the Directive=92s anti-competitive effects. Yet the Court provides little discussion for the economic reasons behind its interpretation; the analysis is merely semantic and definitional, a sharp contrast to its competition decisions. "Database growth rates have gone back to pre-Directive levels, while the anti-competitive costs of database protection are now a permanent fixture of the European landscape. The US, by contrast, gets a nice steady growth rate in databases without paying the monopoly cost." So what kinds of databases are being generated by this bold new right? The answer is somewhere between bathos and pathos. Here are some of the wonderful =93databases=94 that people found it worthwhile litigating over: = A website, consisting of a collection of 259 hyper-links to =93parenting resources,=94 a collection of poems, an assortment of advertisements, headings referring to local news, charts of popular music. The sad list goes on and on. The European Commission might ask itself whether these are really the kind of =93databases=94 which we need a legal monopoly to encourage, and that we want to tie up judicial resources protecting. The point that many more such factual resources can be found online in the United States without such protection, also seems worthy of note. At very least, the evidence indicates that the right is drawn much too broadly and triggered too easily in ways that are profoundly anti-competitive. Finally, is the database right encouraging scientific innovation or hurting it? Here the evidence is merely suggestive. Scientists have claimed that the European database right, together with the perverse failure of European governments to take advantage of the limited scientific research exceptions allowed by the Directive, have made it much harder to aggregate data, to replicate studies, and to judge published articles. In fact, academic scientific bodies have been among the strongest critics of database protection. But negative evidence, by its nature, is hard to produce; =93show me the science that did not get done!=94 Certainly, both US science and commerce have benefited extraordinarily from the openness of US data policy. This is an issue I will deal with in a later column. I was not always opposed to intellectual property rights over data. Indeed, in a book written before the enactment of the Database Directive, I said that there was a respectable economic argument that such protection might be warranted and that we needed research on the issue. Unfortunately, Europe got the right without the research. The facts are now in. If the European Database Directive were a drug, the government would be pulling it from the market until its efficacy and harmfulness could be reassessed. At the very least, the Commission needs a detailed empirical review of the Directive=92s effects, and needs to adjust the Directive=92s definitions and to fine-tune its limitations. But there is a second lesson. There is more discussion of the empirical economic effects of the Database Directive in this 2000 word column than there is in the 600 page review of the effects of the Directive that the European Commission paid a private company to conduct. That is a scandal. And it is a scandal that is altogether typical of the way we make intellectual property policy. President Bush is not the only one to make =93faith-based=94 decisions. /The writer is William Neal Reynolds Professor of Law at Duke Law School, a board member of Creative Commons and the co-founder of the Center for the Study of the Public Domain/ /http://news.ft.com/cms/s/4cd4941e-3cab-11d9-bb7b-00000e2511c8.html / From mpalmedo@cptech.org Wed Nov 24 10:45:01 2004 From: mpalmedo@cptech.org (Mike Palmedo) Date: Wed Nov 24 10:45:01 2004 Subject: [Ip-health] Business leaders look towards APEC-based multilateral FTA Message-ID: <41A4A456.8020405@cptech.org> Regional Trade Pacts Threaten Global Trade Talks Public Agenda (Accra) November 22, 2004 [snip] Leaders of the APEC forum who meet in Santiago at the weekend are expected to discuss a business leaders' proposal for the creation of a Free Trade Area of the Asia-Pacific, or FTAA,P embracing the giant trading groups of the Americas and East Asia. "It would halt the march towards a bipolar region and a tripolar world and resume the process of integration of the Asia-Pacific," Bergsten said. APEC appeared split over the free trade plan. Chile, the United States, Canada, Australia, New Zealand, Taiwan and Singapore back it while others such as China, Japan, Malaysia and Indonesia were cautious or opposed it, APEC sources said. But Hernan Somerville, chairman of the the APEC Business Advisory Council, said the leaders should consider the council's request for a study on the prospect of such a free trade area, which could control nearly half the world's trade. "We have not asked the leaders to launch a negotiation on the Asia-Pacific free trade agreement. What we have basically asked in three letters to the leaders is just a feasibility study be conducted," he said. [snip] From james.love@cptech.org Wed Nov 24 12:23:02 2004 From: james.love@cptech.org (James Love) Date: Wed Nov 24 12:23:02 2004 Subject: [Ip-health] WIPO/DA - Access to Knowledge (a2k) Treaty - Feb 3-4, 2005 Geneva meeting Message-ID: <41A4C2D2.9060604@cptech.org> This is a short note to let people know that TWN, CPTech and IFLA intend to host a February 3 and 4 Geneva meeting to discuss the WIPO development agenda (DA) and a Treaty on Access to Knowledge (a2k). In August 2004, Argentina and Brazil presented a proposal for a development agenda at WIPO. The proposal and many of the comments and discussions are on the web here: http://www.cptech.org/ip/wipo/futureofwipo.html. One element of the proposal was a possible Treaty on Access to Knowledge (a2k). In the original Argentina/Brazil proposal, the context for the a2k treaty concerned access to government funded research. However, many other issues raised in the Argentina/Brazil proposal could logically be discussed within a broader a2k treaty, including for example a treaty on minimum copyright or patent limitations and exceptions (copyright limitations and exceptions were recently discussed at the WIPO SCCR, and will be scheduled as a full agenda item in the June WIPO SCCR meeting), proposals to encourage open access publishing models, free/open source software, access to knowledge problems with legally mandated Technological Protection Measures/Digital Rights Management (TPM/DRM) regimes, the Control of Anticompetitive Practices (Implementation of Articles 8, 31.k and 40 of the TRIPS), implementation of Article 4 of the Doha Declaration on TRIPS and Public Health, and proposals for a protocol on the transfer of technology and knowledge to developing countries, as well as other items mentioned or not mentioned in the Argentina/Brazil proposal. For example, among topics not mentioned in the Argentina/Brazil proposal would be a new protocol with the Patent Cooperation Treaty (PCT) to have global coordination of notice and disclosure of patent claims on proposed standards for bodies like the IETF and the W3C, or the proposal for patent exceptions for public goods projects like the Human Genome Project or the HapMap Project. On October 4, 2004, the WIPO General Assembly issued a =E2=80=9CDecision on= a Development Agenda=E2=80=9D (see below). This decision basically *FAST-TRAC= KS* discussion of the various topics in the development agenda, including multiple meetings, a July 30 2005 report by the WIPO secretariat and consideration of the Development Agenda at the September 2005 General Assembly meeting. In order to help consumer, development and civil society groups engage in this debate, the Third World Network, CPTech and the International Federation of Library Associations and Institutions will be holding a two day meeting in Geneva on February 3 and 4. There will be further details out later, including an agenda. The CPTech contact for the meeting is Manon Ress (manon.ress@cptech.org), for those who want further information. General Assembly Decision on a Development Agenda October 4, 2004 ________________________________________________________________________ Following discussions, the General Assembly adopts the following decision: Recalling that the relationship between development and intellectual property has continuously been raised in several multilateral fora; Taking into account the activities carried out by WIPO in the area of development; Bearing in mind the internationally agreed development goals, including those in the United Nations Millennium Declaration, the Programme of Action for the Least Developed Countries for the Decade 2001-2010, the Monterey Consensus, the Johannesburg Declaration on Sustainable Development, the Declaration of Principles and the Plan of Action of the first phase of the World Summit on the Information Society and the Sao Paulo Consensus adopted at UNCTAD XI; (1) The General Assembly welcomes the initiative for a development agenda and notes the proposals contained in document WO/GA/31/11. (2) The General Assembly decides to convene inter-sessional intergovernmental meetings to examine the proposals contained in document WO/GA/31/11, as well as additional proposals of Member States. To the extent possible, the meetings will be convened in conjunction with the 2005 session of the Permanent Committee on Cooperation for Development Related to Intellectual Property. The meetings, open to all Member States, will prepare a report by July 30, 2005, for the consideration of the next General Assembly. WIPO-accredited IGOs and NGOs are invited to participate as observers in the meetings. (3) The International Bureau shall undertake immediate arrangements in order to organize with other relevant multilateral organizations, including UNCTAD, WHO and UNIDO, WTO, a joint international seminar on Intellectual Property and Development, open to the participation of all stakeholders, including NGOs, civil society and academia. (4) The General Assembly decides to include this issue in its September 2005 session. -- James Love | Consumer Project on Technology http://www.cptech.org | mailto:james.love@cptech.org P.O. Box 19367, Washington, DC 200036 voice +1.202.387.8030 | fax +1.202.234.5176 From rob@essential.org Thu Nov 25 08:52:00 2004 From: rob@essential.org (robert weissman) Date: Thu Nov 25 08:52:00 2004 Subject: [Ip-health] SACU shelves patents in FTA with European countries Message-ID: <41A52031.1050503@essential.org> From: Asia Russell According to this article, three areas of the EFTA that would have an impact on public health and access to medicines--intellectual property rights, as well as investment and government procurement--will not be part of the SACU free trade agreement with Norway, Switzerland, Iceland and Liechtenstein. Asia Russell "The deal with Efta would be a scaled-down version of the original agreement. Efta members earlier agreed to Sacu's request to shelve complex issues such as government procurement, intellectual property and investment." http://allafrica.com/stories/200411230170.html SA Near to Clinching Another Trade Deal Business Day (Johannesburg) NEWS November 23, 2004 Posted to the web November 23, 2004 By Carli Lourens, Trade And Industry Editor Johannesburg SA IS on track to sign its third freetrade agreement next month in a move that will give local exporters increased access to four new markets in Europe. This will advance SA's position in the global race to form free trade agreements . The deal will bring to a close about 18 months of negotiations between the Southern African Customs Union (Sacu) and the European Free Trade Association (Efta). The four countries that make up Efta Switzerland, Norway, Iceland and Liechtenstein are not part of the European Union, with which SA already has a free trade agreement. The Efta deal was expected to harmonise SA's trade relations with all of western Europe. SA's chief trade negotiator, Xavier Carim, said at the weekend that he was optimistic that the deal would be signed next month, although some technical and legal details may have to be concluded at a later stage. Carim said trade ministers of the countries involved may be able to sign off the agreement in May. Sacu had also hoped to conclude a free-trade deal with the US next month , but differences of opinion on several matters have hampered progress to the extent that the December deadline would not be met, said Carim earlier. The deal with Efta would be a scaled-down version of the original agreement. Efta members earlier agreed to Sacu's request to shelve complex issues such as government procurement, intellectual property and investment. The five Sacu member countries were still looking to harmonise their own trade policies on these issues. The deal is important for Efta, because Sacu is the first partner on the African continent with which the Efta states are concluding a comprehensive trade agreement. Switzerland, which is the largest economy in Efta, imports large quantities of precious stones and metals, plastics and vehicles. From Sean.HEALY@geneva.msf.org Thu Nov 25 08:52:19 2004 From: Sean.HEALY@geneva.msf.org (Sean.HEALY@geneva.msf.org) Date: Thu Nov 25 08:52:19 2004 Subject: [Ip-health] The Lancet: The important world of drug prequalification Message-ID: THE LANCET Volume=A0364,=A0Number=A09448=A0=A0 =A0=A020=A0November=A02004 =A0Editorial The important world of drug prequalification On Nov 9, Ranbaxy Laboratories in India voluntarily withdrew all its seven antiretroviral drugs from WHO's prequalification scheme. This list of drugs is a little known (outside the world of essential drugs) but vital part of drug delivery in the developing world. Earlier this year, three of Ranbaxy's and two of Cipla's (also in India) antiretrovirals were also de-listed. What is the prequalification scheme, and why is it important? The scheme is run by the Quality Assurance and Safety: Medicines (QSM) team, part of WHO's Essential Drugs and Medicines Policy department. Much of QSM's work is the development, harmonisation, and promotion of international standards to ensure quality, safety, efficacy, and rational use. In particular, QSM manages the prequalification of drugs and manufacturers for antiretrovirals for WHO, UNICEF, UNAIDS, and UNFPA, antituberculosis drugs for WHO and the Stop TB Partnership, and antimalarials for WHO and Roll Back Malaria. Both the drug and the manufacturing site have to be prequalified. Once on the list, the drug and manufacturer are considered eligible to supply drugs. Manufacturers are inspected for compliance with good manufacturing practices. The inspectors are from drug regulatory authorities from the European Union, Canada, and Switzerland, and they work with regulators from the developing countries where the medicines will be used. The prequalification assessment also evaluates in-vivo bioequivalence tests done by the manufacturer, and QSM also provides local training. Ranbaxy withdrew its antiretrovirals after finding discrepancies in the documentation about the drugs' bioequivalence. The company hopes to resubmit new data by the end of this year. The withdrawals earlier this year came after inspections at contract research organisations showed serious discrepancies between the original bioequivalence data and the results presented, and because of non-compliance with good clinical and laboratory practices. WHO is, of course, presented with an immediate dilemma, because an alternative supplier is not always available. Thus WHO recommends that patients continue using the de-listed product, because the risk of withholding treatment is higher than that of providing medicines whose bioequivalence is not proven but which have otherwise been prequalified. A switch to non-prequalified drugs is not recommended. So the latest news of the withdrawal of much-needed antiretrovirals from the prequalification list is both bad and good. Bad, obviously, for the patients and health carers affected locally. But good news because it shows that this little known part of WHO is effective and has teeth that can bite rapidly. QSM is a small team at WHO's headquarters that knows the importance of training local drug regulatory authorities, and has the ability to use international inspectors in local sites. And prequalification status means that some of the most important drugs are being made safely available in parts of the world where they are most needed. * The Lancet **************************************** Sean Healy Information Officer Campaign for Access to Essential Medicines M=E9decins Sans Fronti=E8res Geneva, Switzerland tel ++41-22-8498 401 fax ++41-22-8498 404 mobile tel ++41-79-239 9271 sean.healy@geneva.msf.org www.accessmed-msf.org From thiru@cptech.org Fri Nov 26 03:46:11 2004 From: thiru@cptech.org (Thiru Balasubramaniam) Date: Fri Nov 26 03:46:11 2004 Subject: [Ip-health] Economist: From bad to awful (The pharmaceuticals industry) Message-ID: <41A6ECC6.5030406@cptech.org> * The pharmaceuticals industry* *From bad to awful* Nov 25th 2004 | LONDON AND NEW YORK From The Economist print edition *Serious allegations about the behaviour of America's Food and Drug Administration are adding to the mounting woes of big drug firms* HOWEVER intense the pain, the troubles of the world's big pharmaceuticals companies have hardly seemed unusual. Half a dozen other industries in America have also been feeling the lash of energetic state regulators, a hostile business press, political scrutiny and the unwanted attentions of plaintiffs' lawyers. Rumours that Michael Moore plans to make a film about the drug industry (whose employees are under strict instructions to keep their mouths shut) had simply added one more item from what is fast becoming a standard list of business headaches in the new century. Yet, over the past week, the drug firms' crisis has appeared to morph into something uniquely dark and dangerous. Suddenly its American regulator, the Food and Drug Administration (FDA), finds itself under attack. And if public confidence in the regulator goes, worried industry executives and company shareholders are asking, what then? On November 18th, David Graham, a scientist in the part of the FDA that oversees the safety of medicines after they have been approved, was called to testify before the Senate's powerful finance committee. The committee wanted to know the circumstances behind the sudden withdrawal by Merck in September of Vioxx, a painkiller that, according to some estimates, may have damaged the hearts of more than 100,000 Americans since the FDA approved its use in 1999. Mr Graham testified that the FDA overvalues the benefits of drugs and =93seriously undervalues, disregards and disrespects drug safety=94. The FD= A has become too chummy with the industry it regulates, hinted Mr Graham. Concerns raised by people such as him that approved drugs might not be safe have met with =93denial, rejection and heat=94. Mr Graham himself had been pressured to change his conclusions about the risks posed by Vioxx=97even as hundreds of Americans were dying every week from side-effects of the drug. America was =93virtually defenceless=94 against another Vioxx, warned Mr Graham, before proceeding to list other looming threats to the nation's health: Crestor (made by AstraZeneca), Serevent (GlaxoSmithKline), Bextra (Pfizer), Meridia (Abbott Laboratories) and Accutane (Roche). *When the drugs don't work* Even as the FDA scrambled to put out its side of the story, Mr Graham's testimony was spreading havoc in the markets. AstraZeneca's share price fell by 10%. Shares in GlaxoSmithKline fell by 6%. Although Merck's share price hardly budged, traders have already knocked $40 billion off the firm's value in the two months since it withdrew Vioxx. Share prices and valuations continue to collapse across the entire pharmaceuticals industry. The big drug firms now face several pressing new questions. The first is how the FDA will react to the outbreak of civil war within its ranks. According to much debated analysis by the Tufts Centre for the Study of Drug Development, an independent research group, it takes 10-15 years and, on average, $897m to bring a new drug to market. Under David Kessler, who ran the FDA in the 1990s, the agency took much flack for being too slow and too cautious in the way it approved new drugs, adding costs to the system and denying patients potentially life-saving medicines. More recently, the FDA has tried to streamline things by reducing management (it says that it has trimmed its bureaucracy to only four layers), adopting new scientific techniques to improve the review process and adding a fast-track approval system for important new drugs. Under fire, the FDA may retreat hastily to its old, risk-averse ways=97if, indeed, it ever shed them in the first place. According to the Centre for Medicines Research International, a research group, the time it takes the FDA to approve new drugs has actually risen a bit in the past few years, from one year in 1998 to 1.3 years in 2002. (The FDA remains quicker than Europe, which takes 1.4 years, and Japan, which takes 1.6 years.) A second question is whether the momentum now building to reform the FDA will carry the day. Mr Graham's call last week to create a new regulator responsible for the safety of approved drugs has since been endorsed by Charles Grassley, who heads the Senate's finance committee, and by an editorial in the /Journal of the American Medical Association/ (JAMA). Critics of this proposal argue that a new layer of regulation would encourage even more risk aversion, which would heap more costs and uncertainty on to drug firms. Either way, the FDA's current reliance on the willingness of drug companies to report problems with products that can potentially earn them billions of dollars a year is likely to change. At a minimum, the FDA is likely to get more money and more staff to conduct more of its own research into the safety of the drug industry's products. Beyond that, America might even borrow from Europe's drug regulator, the European Agency for the Evaluation of Medicinal Products (EMEA). This agency reauthorises (or not) drugs after five years on the market. Such review gives the EMEA the power to enforce drug-industry promises to pursue drug-safety studies after medicines have gone on sale, and an opportunity to take stock of whatever new evidence has emerged about the balance of risk and benefits for any particular drug. In America, drugs firms have completed fewer than half of the post-sales studies they have promised the FDA. Many of these studies, which can be very costly, have not even been started, says /JAMA/. Perhaps the trickiest question arising from the FDA's woes is what will happen to the industry's soaring (yet unquantifiable) legal and reputational risks. A key part of Merck's defence against the hundreds of lawsuits it faces over Vioxx will be that it kept no information from the FDA, and diligently abided by its regulator's wishes. That defence may carry less clout if Americans come to view the FDA as corrupt and as reckless about the safety of Americans as the drug-firm bosses who feature so regularly in the newspapers and on the evening news these days (see article = ). These bosses may find they have the same problem defending themselves as executives accused of fraud in the past few years: what good does it do to plead reliance on the advice of accountants, lawyers and bankers if these supposed checks and balances stand accused of wrongdoing, too? A series of articles published on the JAMA website this week suggested that poor regulatory design had allowed Bayer, a German company, to ignore clear signs that its cholesterol-lowering drug, Baycol, caused potentially catastrophic muscle damage when taken with certain other medicines. Bayer is defending itself against litigation over the drug. Meanwhile, Mr Graham's testimony may attract further interest from criminal prosecutors at the Department of Justice. Merck has already said that federal prosecutors have subpoenaed it for information relating to the way it researched, marketed and sold Vioxx. Also testifying before Congress last week, Merck's boss, Ray Gilmartin, looked terrified. Will other drug-firm bosses be next? From thiru@cptech.org Fri Nov 26 09:18:02 2004 From: thiru@cptech.org (Thiru Balasubramaniam) Date: Fri Nov 26 09:18:02 2004 Subject: [Ip-health] CPTech Summary of Proceedings at WIPO IGC (November 2004) Message-ID: <41A73AAB.4040300@cptech.org> The CPTech delegation to the Seventh Session of the WIPO Intergovernmental Committee (IGC) on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (GRTKF) was represented by Thiru Balasubramaniam and Johanna Gibson. This IGC took place in Geneva from November 1-5, 2004. The following summary attached below was written by Johanna Gibson. Two dominant themes emerged from the discussions at the IGC: 1) The international dimension- The African Group, the Andean Community and indigenous groups such as Call of the Earth and the Saami Council emphasized the need for an international instrument for the protection of genetic resources and traditional knowledge. In particular, the African Group reminded the Committee that the International Bureau was requested to produce drafts of possible international instruments. 2) The contractual approach versus the patent approach- Several delegations including the African Group, the Andean Group, Brazil, and India rejected the contractual solution as a means to combat biopiracy and misappropriation deeming this approach as ultimately inadequate and possibly unjust given the imbalance in bargaining positions and lack of international control over such agreements. The ongoing emphasis and work on the contractual basis was largely supported by developed countries, including the United States, and many industry observers, drawing upon incentive arguments, mitigation of risk, and protection of the market certainty. It should be noted that the discussions on mandatory disclosure should be viewed in the light of the recent submission by Brazil, India, Pakistan, Peru, Thailand and Venezuela on September 21, 2004 to the WTO Council for TRIPS (IP/C/W/429) on the "Elements of the Obligation to Disclose the Source and Country of Origin of Biological Resource and/or Traditional Knowledge Used in an Invention." Thiru Balasubramaniam Geneva Representative Consumer Project on Technology ---------------------------------------------- World Intellectual Property Organization Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore Geneva, November 1 to 5, 2004 by Johanna Gibson A substantial number of countries, predominantly developing countries, affirmed the call for protection based upon a framework of an international instrument or instruments, with the implementation of appropriate policy and legal mechanisms at community, national, and regional levels, based upon the international objectives and principles set out in that instrument. The African group, in particular, emphasised the international dimension in the context of the new mandate of 2003, including the possible development of international instruments to achieve international standards of protection. Recalling the Sixth Session, the African group reminded the Committee that the Secretariat was asked to produce drafts of possible international instruments and stated, =93We wish to reaffirm in this regard that discussing the draft policy and core principles is not an end in itself, but should be a basis for further discussions on legal status of protection and towards what should be internationally binding instruments on GR and TK.=94 With respect to GR, Peru made the following statement on behalf of the Andean Community: =93Only with an international legally binding system and with the universal adoption of the certificate of origin can we face up to the phenomenon of biopiracy and due respect of national sovereignty of our peoples over GR.=94 Other members, including Syria, Colombia, Ecuador, Peru, and Bolivia also supported this process towards an international system of protection for GRTKF. Indeed, the current work of the Committee was criticised by the delegation of Kenya, which stated, =93We note with concern that the international dimension is diluted in such a matter that the work of this committee becomes only to coordinate and nationalize national laws.=94 As Algeria went on to state, =93Holders of TK need to be able to have recourse to an international legal system of protection of this knowledge, and not just to their national systems which might be ineffective, because it depends on the means that the national communities or indigenous communities do not necessarily have.=94 The importance of a binding international agreement was also supported by indigenous groups (including Call of the Earth, the Saami Council, which called for the recognition of customary laws and practices within such a system, and FAIRA) and intergovernmental organizations (including ARIPO). Without such international standards at this stage, the protection of traditional cultural expressions may be unclear. As the Kenya delegation stated, =93Misappropriation of TCEs is one of the main challenges =96 sanctions, remedies, and enforcement need to be clear.=94 Morocco identified diversity in TCEs, and argued that this diversity has particular implications for the scope of protection: =93there are different forms of cultural expressions, they are very diverse, and therefore scope of protection should take into account this diversity.=94 The representative of ARIPO stated that it is imperative that international standards be recognised in order =93to avoid free-riding, misappropriation, and reduce impediments to innovation.=94 Similarly, the patent system was identified by the African group and others as the important (and only) international system that may govern the use of traditional knowledge and genetic resources at this present time. As the representative of Ecuador stated: It is not the contractual way that can solve problem of biopiracy, misappropriation, or the problems of disclosure of source or distribution of benefits. This approach is insufficient. It is voluntary, private, and cannot solve problems of use and exploitation of GR. We repeat the importance of dealing with this issue from viewpoint of patents and taking into account all the progress that has been made on this problem by CBD and FAO. In this view of patent law as providing the only international legal instrument at this time, several groups called for closer consideration of the interaction between the patent system and principles of equitable benefit sharing and prior informed consent. The lack of attention to this relationship was criticized and questioned, given that many countries, including the African group (which reiterated its rejection of patents on life forms, supported by statements of the Third World Network), have identified the underlying centrality of patent system. Indonesia also recommended links between evidence of prior informed consent and benefit sharing, and the validity of patents, as a way of addressing the problem of misappropriation of genetic resources. Similarly, Ecuador argued for the recognition of a close link between genetic resources and patent law, and rejected a contractual basis for a solution. Indeed, several groups questioned the viability of a contractual solution given the very absence of an international standard, other than the patent system, described as a =93privatist approach=94 by Brazil. The ongoing emphasis and work on the contractual basis was largely supported by developed countries, including the United States, and many industry observers, drawing upon incentive arguments, mitigation of risk, and protection of the market certainty. In other words, incentive was linked not to rewards for creativity or custodianship, but to investment and ownership. For instance, the Biotechnology Industry Organization (BIO) stated, =93We question whether use of patent system is most viable or effective way of promoting goal of greater transparency and accountability,=94 and rejected requirements of mandatory disclosure in the patent system, arguing instead, =93We urge the International Bureau to solicit comments on other methods for monitoring access and use of GR.=94 This approach was strongly rejected by a large number of delegations from developing countries (including Brazil, the African group, India, the Andean countries) as wasteful of resources, diverting attention from more important work, and ultimately inadequate and possibly unjust given the imbalance in bargaining positions and lack of international control over such agreements. The contractual basis for protection against misappropriation and biopiracy was similarly rejected by NGO observers, including the Third World Network, which identified the lack of international harmonization with respect to the commercialisation of benefits arising from access to genetic resources through such agreements, thus leaving the cross-border enforcement of agreements unclear= . Despite the centrality of the patent system, this is not a substitute for an international instrument directed to genetic resources, TK, and folklore. Several groups rejected the call for consistency with and support for existing IP systems, which occurs throughout the documents of the Seventh Session, arguing that this would seem to subordinate protection to the existing intellectual property system of protection, commodification, and commercialisation. Indeed, it was argued that the problem of misappropriation suggests, to the contrary, that there is a need to make the existing IP system supportive of the protection of TK. As the African group argued, the most fundamental concern for devising a regime of protection should be the expectations of TK-holders. Similarly, the Call of the Earth argued, =93In addition to the intergenerational nature of TK, collective ownership, permanent innovation and the value per se that it represents for indigenous peoples, regarding policy options and legal mechanisms, we have reservations about directing the discussion through IPR, especially through the patent system, because this system is incompatible with TK.=94 As the representative of the Call of the Earth explained, =93TK is intergenerational in nature, subject to a constant process of innovation, related to our culture, with value per se, closely linked to lands. IP systems as they exist can=92t give respect to TK.=94 Brazil urged the Committee =93to approach protection of TK within the broader framework of human rights and indigenous rights law, which we believe transcends the realm of IP law. We do not think that efforts to protect TK should necessarily be seen as an attempt to extend scope of IP regime. Rights of our indigenous peoples over their TK are un-renounceable, im-prescriptable, inalienable prior rights that precede the advent of state law.=94 The statement of the delegation of Brazil continued, =93The protection of TK cannot be subordinated in any way to the existing IP regime =85 Indigenous and traditional communities often constitute some of the most disenfranchised and impoverished members of society whose rights have not been duly recognised,=94 and urged the Committee =93to ensure the IP system is responsive to broader societal concerns in all countries.=94 Related to these concerns, the representative of the Tulelip Tribe supported calls for recognition of the relevance of =93higher laws=94 of human rights, rather than confining the debate within intellectual property regimes. Further, the representative of the Tulelip Tribe raised questions about the viability of an approach based upon balance and proportionality, arguing that this was an inappropriate application of a civil society concept to indigenous communities already governed by local customary laws with respect to access. The categorization of the knowledge of traditional and indigenous groups was also questioned. In reiterating the need for an international sui generis system, the Andean community identified the important links between TK, biopiracy, genetic resources, and community pride. In this regard, the Andean community and others rejected the importance of ongoing sharing of national experiences, and called for active participation of indigenous communities in the development of an appropriate and international mechanism. Call of the Earth in particular recommended a more holistic approach to protection, where protection is linked to the cultural identity of indigenous peoples and a flexible and holistic approach is essential. As the delegation of Ecuador explained, =93This relationship between TK and GR is essential to bear in mind, so that we can determine any principle whatsoever or any objective whatsoever, that might guide drawing up of any international standards.=94 Several delegations identified the holistic protection of GRTKF as integral to the cultural identity of indigenous peoples. The Call of the Earth made the following statement: "Handling TCEs separately from TK is going to be inappropriate given the way these exist in indigenous communities. This kind of isolated treatment will not over the long-term ensure proper protection for TCEs and TK. Dances and songs are not separated from traditional clothes, production of cloths, handicrafts, traditional materials and production. This is an artificial separation which undermines the holistic nature where TK is intrinsic to expressions of culture. This separation is damaging to our possibility of being creative and innovative in the future, and also encourages abuse and misappropriation of both TK and TCEs =96 because the community which produces them does not have the tools to protect them." Similar to the statements of the Saami Council, the Call of the Earth called for greater and more systematic recognition of customary law: Therefore, we appeal for this committee to consider integral models which will be closer to the local models of administration used for management of tradition. Further, the delegation of Papua New Guinea stated, =93For indigenous peoples in many situations, after everything has been taken away from them, or because they have been left out of mainstream life, culture is all they have left.=94 Further to this point, the representative of FAIRA argued that the misappropriation of TCEs =93can actually be a denial of a people of a cultural identity,=94 and suggested that this denial of culture can amount to =93an exercise of genocide.=94 From Sean.HEALY@geneva.msf.org Mon Nov 29 03:18:00 2004 From: Sean.HEALY@geneva.msf.org (Sean.HEALY@geneva.msf.org) Date: Mon Nov 29 03:18:00 2004 Subject: [Ip-health] MSF: Guatemalan Congress Repeals Law That Restricted Access to Medicines Message-ID: M=E9decins Sans Fronti=E8res Guatemalan Congress Repeals Law That Restricted Access to Medicines MSF warns that this step forward could be reversed by similar provisions in the recently signed United States-Central American Free Trade Agreement (CAFTA) Geneva/Guatemala City, November 26, 2004: The Guatemalan Congress's repeal of a law that severely restricts people's access to affordable essential medicines is a positive step forward. The international humanitarian medical aid organization M=E9decins Sans Fronti=E8res (MSF) said today that= the government of Guatemala should now take advantage of this decision to ensure treatment for greater numbers of Guatemalans living with HIV/AIDS and other infectious diseases. But MSF also warned that this step forward could be undermined and reversed by similar provisions included in the recently signed United States-Central American Free Trade Agreement (CAFTA). In 2003, the Guatemalan government modified its national intellectual property law with Decree 9-2003, which provided five years of "data exclusivity" on drugs registered for use in the country. This provision created an automatic five-year delay in the availability of generic medicines regardless of their patent status in a country. For the nearly 70,000 Guatemalans currently living with HIV/AIDS ? 7000 of whom are in urgent clinical need of such treatment ? five years without affordable generic medicines could be a death sentence. Presently, only 2700 Guatemalans with HIV receive antiretroviral treatment. "A lot of people throughout Guatemalan society succeeded in pressuring their government to overturn a law that undermined public health," said Pere-Joan Pons, spokesperson for MSF's mission in Guatemala. "Now, the Ministry of Health will need to act to urgently expand access for all the Guatemalans who would otherwise die without treatment." However, MSF warned that CAFTA includes "data exclusivity" and other restrictive intellectual property measures and extends them throughout the entire Central American region. This will further prevent Costa Rica, El Salvador, Guatemala, Honduras, and Nicaragua from taking advantage of flexibilities found in the existing World Trade Organization agreement and block generic competition ? the only proven mechanism for achieving sustained and systematic price reductions. "We can't stop at the repeal of the Guatemalan law which blocked patients from receiving life-saving medicines. Repealing Decree 9-2003 will have little meaning if this and other intellectual property restrictions are implemented through CAFTA," said Ellen 't Hoen, the director of policy advocacy for MSF's Campaign for Access to Essential Medicines. MSF has been treating people living with HIV/AIDS in Guatemala since 2001. Today, MSF medical teams treat more than 1,600 patients with ARVs in two Guatemala City hospitals, and health centers in Coatepeque and Puerto Barrios. Many of the restrictive intellectual property provisions in CAFTA are also included in free trade agreements completed with Singapore, Chile, and Morocco, as well as in the Free Trade Agreement of the Americas (FTAA) and regional agreements with four Andean countries (Bolivia, Colombia, Ecuador, and Peru) and five southern African countries in the Southern African Customs Union (Botswana, Lesotho, Namibia, South Africa, and Swaziland.) For more information, please call: In Guatemala City, Pere-Joan Pons, +502 2250 0087 or +502 5709 4694, Emmanuel Gue, +502 2220 6121 or +502 5318 5634, In Geneva, Sean Healy, +4122 849 8401 or +4179 239 9271. ### **************************************** Sean Healy Information Officer Campaign for Access to Essential Medicines M=E9decins Sans Fronti=E8res Geneva, Switzerland tel ++41-22-8498 401 fax ++41-22-8498 404 mobile tel ++41-79-239 9271 sean.healy@geneva.msf.org www.accessmed-msf.org From Sean.HEALY@geneva.msf.org Mon Nov 29 03:18:13 2004 From: Sean.HEALY@geneva.msf.org (Sean.HEALY@geneva.msf.org) Date: Mon Nov 29 03:18:13 2004 Subject: [Ip-health] The Lancet: Vioxx, the implosion of Merck, and aftershocks at the FDA Message-ID: The Lancet Volume=A0364,=A0Number=A09449=A0=A0 =A0=A027=A0November=A02004 Comment Vioxx, the implosion of Merck, and aftershocks at the FDA Richard Horton See Articles Summary Today we publish results from a cumulative meta-analysis which show that the unacceptable cardiovascular risks of Vioxx (rofecoxib) were evident as early as 2000-a full 4 years before the drug was finally withdrawn from the market by its manufacturer, Merck. This discovery points to astonishing failures in Merck's internal systems of post-marketing surveillance, as well as to lethal weaknesses in the US Food and Drug Administration's regulatory oversight. In a recent Editorial, we commended Merck for acting promptly in the face of new findings about the safety of Vioxx. Our praise was premature. The evidence showing that Vioxx caused significant adverse events was apparent well before data from the APPROVe trial triggered Merck's overdue intervention. This week's report by Peter J=FCni and colleagues will add significant weight to ongoing litigation against Merck by patients who believe they were harmed by this drug. These findings also come in the wake of new disclosures that suggest Merck was indeed fully aware of Vioxx's potential risks by 2000. Investigations by the Wall Street Journal have revealed e-mails that confirm Merck executives' knowledge of their drug's adverse cardiovascular profile-the risk was "clearly there", according to one senior researcher. Merck's marketing literature included a document intended for its sales representatives which discussed how to respond to questions about Vioxx-it was labelled "Dodge Ball Vioxx". Given this disturbing contradiction- Merck's own understanding of Vioxx's true risk profile and its attempt to gloss over these risks in their public statements at the time-it is hard to see how Merck's chief executive officer, Raymond Gilmartin, can retain the confidence of the public, his company's most important constituency. The FDA's position is no less comfortable. The public expects national drug regulators to complete research, such as that published by J=FCni and colleagues, in their ongoing efforts to protect patients from undue harm. But, too often, the FDA saw and continues to see the pharmaceutical industry as its customer-a vital source of funding for its activities-and not as a sector of society in need of strong regulation. Published online November 5, 2004. http://image.thelancet.com/extras/04cmt396web.pdf From galk@free.fr Mon Nov 29 03:18:24 2004 From: galk@free.fr (=?ISO-8859-1?Q?Krikorian_Ga=EBlle?=) Date: Mon Nov 29 03:18:24 2004 Subject: [Ip-health] France: Socialists asking for a Commission to inquire into Pharma info Message-ID: <0D2D0315-404A-11D9-B6A3-000D933B3D7E@free.fr> The socialists deputies in France are asking for the creation of a Parliamentary Commission to inquire into the nature and the quality of the scientific information provided by the pharmaceutical industry to the public institutions and to health professionals. Here is there press statement (sorry, i only have it in French). GK --- Communiqu=E9 de Presse de Jean-Marie LE GUEN D=E9put=E9 du 13=E8me arrondissement de Paris Responsable des questions de sant=E9 pour le groupe socialiste =E0 l=92Assembl=E9e Nationale Jean-Marie Le Guen, au nom du groupe socialiste, demande la cr=E9ation d=92une commission d=92enqu=EAte parlementaire sur la nature et la qualit= =E9 de l=92information scientifique fournie par l=92industrie pharmaceutique sur ses produits aux pouvoirs publics et aux professionnels de sant=E9. Depuis quelques mois plusieurs =E9v=E9nements de tr=E8s grande importance sont venus alimenter les doutes sur la qualit=E9 et l=92impartialit=E9 des informations transmises par l=92industrie pharmaceutique. Cela concerne d=92une part l=92innocuit=E9 de certains produits, comme ce fut le cas =E0 propos du Vioxx, et la qualit=E9 r=E9elle des innovations th=E9rapeutiques d=92un certain nombre d=92autres, pour diverses classes th=E9rapeutiques allant des Coxib en passant par les anti-d=E9presseurs. Il y a aussi tout lieu de s=92inqui=E9ter sur le r=F4le de plus en plus av=E9r=E9 de la pres= sion commerciale exerc=E9e par l=92industrie sur la prescription. Il appara=EEt donc n=E9cessaire d=92examiner et le cas =E9ch=E9ant de r=E9=E9valuer les r= =E8gles de transparence de l=92information fournie =E0 l=92occasion de l=92introductio= n, l=92=E9valuation et la prescription des produits pharmaceutiques. Ce d=E9bat a lieu aujourd=92hui au plan mondial. Les Etats-Unis, de loin premiers producteurs et premiers consommateurs de m=E9dicaments, notamment au travers de la logique judiciaire, se saisissent de ces questions. En son temps, lors du d=E9bat sur les lois de Sant=E9 publique et de r=E9forme de l=92Assurance maladie, Jean-Marie Le Guen et le groupe socialiste avaient demand=E9 au gouvernement d=92agir en ce domaine. Aujourd=92hui, des parlementaires d=92autres groupes, et notamment de la majorit=E9, s=92expriment dans le m=EAme sens. A l=92=E9vidence,=A0le doute et l=92inqui=E9tude grandissent. Il est du dev= oir de l=92Assembl=E9e nationale d=92apporter =E0 nos concitoyens les garanties de Sant=E9 publique et l=92efficacit=E9 =E9conomique auxquels ils aspirent. CONTACT=A0: 01 40 63 94 17 From hjyang30@yahoo.co.kr Mon Nov 29 03:18:35 2004 From: hjyang30@yahoo.co.kr (HJ YANG) Date: Mon Nov 29 03:18:35 2004 Subject: [Ip-health] Korean Bill for August 30th solution implementation Message-ID: <20041127142710.34623.qmail@web70307.mail.krs.yahoo.com> -- [ Picked text/plain from multipart/alternative ] Hello, everyone! I am very pleased to inform you that 15 Korean Assembly Members submitted a= bill for amending Korean Patent Act to the National Assembly on November 2= 6, 2004. The bill is intended to enhance the possibility to grant for a compulsory l= icense for public interest and to reflect the decision of August 30, 2003, = of the WTO General Council with regard to a compulsory license for export o= f pharmaceutical products. The summary of the bill will be attached hereto= . You can find the English full translation of the bill at http://www.ipleft.= or.kr/patent/patent_bill This is a small success of effort made by some Korean citizen groups, such = as IPLeft, JinboNet, People=A1=AFs Health Coalition for Equitable Society a= nd Korean Federation of Medical Groups for Health Rights, during several la= st months. However, the Korean Intellectual Property Office (KIPO) is trying to make a= false charge against the bill. It seems that the KIPO does not want the bi= ll to be passed. Some officials in the KIPO argued that the bill excessivel= y limits the interest and right of patentees. In the procedure of making a= law in the Korean National Assembly, any opposite opinions of administrati= ve authorities generally make a strong effect on whether any bill is passed= or not, which we are concerned about. Your support statements or emails will be therefore very helpful for us. ---------------------------------------------------------------------------= ------ Attachment: Summary of Bill for Amending Korean Patent Act (it is excerpt from an article by a patent attorney, Hee-Seob, Nam, who mad= e the bill together with the above citizen groups) A. Compulsory License for Public Interest Current law requires that the working of patented invention by a licensee s= hould be made non-commercially. As a patent right relates to commercial and= industrial use, it would follow that a =A1=B0non-commercial working=A1=B1 = falls outside such right. Thus, this requirement becomes absurd and illogic= al. It seems that the requirement of =A1=B0non-commercial working=A1=B1 ste= ms from misunderstanding of =A1=B0public non-commercial use=A1=B1 in TRIPS = Article 31. The Bill deletes the word =A1=B0non-commercially=A1=B1 and adds= =A1=B0particular necessity=A1=B1 requirement. The addition of the particul= ar necessity is the result of negotiation with the KIPO. In addition, the bill newly introduces further grounds for granting a comp= ulsory license, =A1=B0national emergency and other extreme urgency,=A1=B1 i= nto the patent law. B. Export of Patented Medicine (Implementing Para 6 of Doha Declaration) (1) Any one who intends to export pharmaceutical product to eligible impo= rting country may request a compulsory license to the Commissioner of the K= IPO. (2) Eligible importing country includes: LDCs designated by the UN; non-L= DC WTO member country; and non-WTO member country. The applicant seeking fo= r a compulsory license must submit documents showing that importing country= has given notice to the Council for TRIPS or government of Korea the name = and expected quantities of the pharmaceutical product needed and the import= ing country has granted or intends to grant a compulsory license where the = pharmaceutical product has been patented in the importing country. In case = of non-LDC country, the applicant has to submit documents showing that the = importing country has insufficient or no capacity for the production of the= pharmaceutical country. (3) Prior negotiation is exempted where: (i) prior negotiation has been f= ailed in importing country; (ii) 30 days have passed after asking negotiati= on with no agreement; and (iii) national emergency, public non-commercial u= se or anti-competitive act in importing country. (4) Mandatory: If the importing country is eligible importing country and= necessary documents are submitted, the Commissioner shall grant a compulso= ry license. The decision shall be made within 60 days from the filing of th= e request. (5) Remuneration The remuneration to be paid by the licensee to the patentee is determined b= y the following formula: (quantity) x (sale price) x (contribution rate) x = (basic rate). =A1=B0sale price=A1=B1 means an amount which equals the sum of the cost of production and the costs incurred for i= mplementing the compulsory license, =A1=B0contribution rate=A1=B1 is the ra= tio of the patent used in the manufacture of the product, and =A1=B0basic r= ate=A1=B1 is 4%. The basic rate may be adjusted within plus or minus 2% in = consideration of the innovative nature of the patent and economic value in = the importing country. When the remuneration cannot be determined by the fo= rmula, the Commissioner can determine the comparable remuneration based on = its consideration of the economic value of the patent, prices of the import= ing country and the international humanitarian interest. (6) The compulsory licensee can ask modification of the web site address an= d package or labeling. C. Positions of the KIPO to the Bill (1) Premature to amend the Patent Act. The KIPO argues that we have to wa= it until the Article 31(f) of TRIPS is finally revised by reflecting the De= cision of August 30, 2003. (2) No need to specifically regulate the process and document in Patent A= ct. The KIPO wants to have regulation in the form of Presidential Decree th= at may be prepared by the KIPO without review of National Assembly. (3) Objections to the mandatory proceeding and specific rule for the remu= neration. * * * --------------------------------- =C3=D6=B4=EB 100MB, =B4=F5=C0=CC=BB=F3 =BF=EB=B7=AE =B0= =ED=B9=CE=BE=F8=B4=C2 =BE=DF=C8=C4! =B8=DE=C0=CF=C0=BB =BD=E1=BA=B8=BC=BC= =BF=E4. = = =BE=DF=C8=C4! =BA=F1=C6=AE=B9=DA=BD=BA =C3=D6=BD=C5=B0=EE, =C3=DF=C3=B5=B0=EE, =B0=A1=BF=E4, OST= , =C6=CB=BC=DB, =B9=C2=C1=F7=BA=F1=B5=F0=BF=C0 = =09=09 =09=09 = = =BE=DF=C8=C4! =B8=F0=B9=D9=C0=CF =C3=D6=BD=C5 =C8=DE=B4=EB=C6=F9 =C1=A4=BA=B8, =BA=A7=BC= =D2=B8=AE, =C4=B3=B8=AF=C5=CD, =B9=AE=C0=DA=B8=DE=BC=BC=C1=F6 From james.love@cptech.org Mon Nov 29 03:18:44 2004 From: james.love@cptech.org (James Love) Date: Mon Nov 29 03:18:44 2004 Subject: [Ip-health] Indonesian government use/compulsory license Message-ID: <41AAD9F0.50506@cptech.org> The Third World Network and Health Action International, in connection with MSF, CPTech, WHO and others, is holding a workshop in Kuala Lumpur, discussing intellectual property rights and access to medicine. One presentation from Indonesia reported a =93government use=94 license for 3TC and Nevirapine. The license was issued on 5 October 2004, and is signed by Megawati Soekarnoputri, 15 days before she left the presidency. One surprise was the royalty rate, which is just .5% of the generic net selling price. The license is one and a half pages, with a half page appendix. I believe one of the participants will post a copy to ip-health. The grounds for the license is concise: =93The exploitation of patent of Antiretroviral Drugs by the Government is meant to comply the urgent need of community in the effort to control HIV /AIDS epidemic.=94 The license notes the Minister of Health =93may appoint a Pharmaceutical Factory as the patent exploiter for and on behalf of the Government to exploit the patent by taking into account the recommendations from Head of National Drug and Food Control Authority.=94 Jamie -- James Love, Director, CPTech, http://www.cptech.org Consumer Project on Technology in Washington, DC PO Box 19367, Washington, DC 20036, USA Tel.: 1.202.387.8030, fax: 1.202.234.5176 Consumer Project on Technology in Geneva 1 Route des Morillons, CP 2100, 1211 Geneva 2, Switzerland Tel: +41 22 791 6727 Mobile +1.202.361.3040 james.love@cptech.org From relliott@aidslaw.ca Mon Nov 29 10:40:01 2004 From: relliott@aidslaw.ca (Richard Elliott) Date: Mon Nov 29 10:40:01 2004 Subject: [Ip-health] =?iso-8859-1?Q?G=E9n=E9riques_antisida:_la_France_s'y_met_--_Lib=E9rati?= =?iso-8859-1?Q?on=2C_23_novembre_2004?= Message-ID: <20041124153924.BSNS1708.tomts31-srv.bellnexxia.net@RichardPC> This is a multi-part message in MIME format. -- [ Picked text/plain from multipart/alternative ] LIB=C9RATION A Dakar, Douste-Blazy annonce une loi qui permettra la libre exportation ve= rs le Sud. G=E9n=E9riques antisida : la France s'y met Par Florent LATRIVE mardi 23 novembre 2004 (Liberation - 06:00) Dakar envoy=E9 sp=E9cial http://www.liberation.fr/page.php?Article=3D256077 pr=E8s le Canada et la Norv=E8ge, la France va permettre aux laboratoires s= p=E9cialistes de la copie de m=E9dicaments d'exporter des mol=E9cules =E0 bas prix vers les pays du Sud,= m=EAme si celles-ci sont prot=E9g=E9es par des brevets. Le ministre de la Sant=E9 Philippe Douste-Bl= azy a d=E9voil=E9, hier =E0 Dakar, le texte d'un projet de loi qui ferait de la France le troisi=E8me pays du mon= de =E0 se mettre aux normes de l'accord de l'OMC du 30 ao=FBt 2003. Celui-ci est destin=E9 =E0 facilite= r l'acc=E8s des pays les plus pauvres aux traitements =E0 des co=FBts planchers, notamment dans le cas du= sida. =ABIl faut des m=E9dicaments pour le Sud, de qualit=E9 et bon march=E9=BB, a d=E9clar=E9 l= e ministre, affirmant que le texte serait pr=E9sent=E9 au Parlement en d=E9cembre ou en janvier, sauf si le r= =E8glement europ=E9en similaire en projet =E0 Bruxelles aboutit dans l'intervalle. Une annonce attendue faite = au cours d'un s=E9jour express de 24 heures dans la capitale s=E9n=E9galaise, o=F9 le ministre a = =E9voqu=E9 le sujet avec le pr=E9sident Abdoulaye Wade. Innovations. Les pays ravag=E9s par le sida pouvaient jusque-l=E0 s'approvi= sionner en copies de mol=E9cules =9D les g=E9n=E9riques =9D, notamment en Inde : ce pays ne reco= nna=EEt pas les brevets sur les m=E9dicaments et des firmes comme Ranbaxy ont ainsi pu dupliquer les antir= =E9troviraux d'Abbott ou Merck. Cette concurrence a permis, en moins de quatre ans, de faire chuter = le co=FBt du traitement, pass=E9 de plus de 10 000 dollars par patient et par an =E0 un montant vari= ant de 300 =E0 500 dollars. Elle a aussi suscit=E9 des innovations : l=E0 o=F9 les patients trait=E9s a= vec des m=E9dicaments =ABde marque=BB doivent prendre un cocktail de trois mol=E9cules, fournies par trois labos = diff=E9rents, l'absence de respect des brevets a permis =E0 certains g=E9n=E9riqueurs de proposer une = combinaison en une prise qui facilite ainsi un traitement contraignant. Au 1er janvier 2005, cette situation doit changer : selon l'accord sur les = =ABaspects de droit de propri=E9t=E9 intellectuelle touchant au commerce=BB (Adpic), sign=E9 dans = le cadre de l'OMC, l'Inde et d'autres pays interm=E9diaires devront respecter les brevets. Au risque de = tarir les sources d'approvisionnement en g=E9n=E9riques des pays sans capacit=E9 de productio= n pharmaceutique et tenus de se plier aux tarifs des labos =E9trangers. C'est =E0 cela que les membres de l= 'OMC ont voulu rem=E9dier avec l'accord du 30 ao=FBt 2003 : les pays d=E9sireux de s'approvisionner en g= =E9n=E9riques pourront le faire en demandant =E0 un pays qui dispose d'une industrie pharmaceutique de faire s= auter des brevets gr=E2ce =E0 une =ABlicence obligatoire=BB r=E9serv=E9e =E0 l'exportation. Des g=E9n=E9r= iques =E0 bas prix pourraient ainsi =EAtre encore achemin=E9s au sud, malgr=E9 le couperet du 1er janvier. Philippe Douste-Blazy juge =ABg=E9n=E9reuse=BB la transposition fran=E7aise= de cet accord : l=E0 o=F9 le Canada a limit=E9 le m=E9canisme =E0 certaines maladies graves et aux pays les plus = pauvres, la France n'a pas ajout=E9 de bornes =E0 une proc=E9dure d=E9j=E0 complexe. Le texte propose = de plus la possibilit=E9 de faire sauter plusieurs brevets en une seule fois, afin d'autoriser la production = des combinaisons de m=E9dicaments =E0 prise unique. Inqui=E9tudes. Malgr=E9 ces largesses, les difficult=E9s restent nombreuses= . Pour =E9viter que les m=E9dicaments ainsi copi=E9s soient r=E9import=E9s dans les pays d=E9velopp= =E9s, les pilules devront =EAtre d'une couleur identifiable. Et le processus implique un paquet de d=E9- marches a= dministratives, dans plusieurs pays. =ABL'industrie du g=E9n=E9rique est une industrie comme les= autres, je ne sais pas si cela sera assez incitatif pour qu'elle se lance dans l'aventure=BB, estime Emman= uel Trenado, responsable international de l'association Aides. Des inqui=E9tudes auxquelles s'ajoute= la propension des Etats-Unis =E0 multiplier les accords bilat=E9raux ou r=E9gionaux de libre-= =E9change, obtenant au passage le durcissement des r=E8gles en mati=E8re de brevet. Des contraintes suppl=E9m= entaires qui pourraient vider de sa substance le projet fran=E7ais. __________________________________ Richard Elliott Director, Legal Research & Policy Canadian HIV/AIDS Legal Network 890 Yonge Street, Suite 700 Toronto, Ontario, Canada M4W 3P4 Tel: +1 (416) 595-1666 Fax: +1 (416) 595-0094 E-mail: relliott@aidslaw.ca Web: www.aidslaw.ca -- From pierchir@club-internet.fr Mon Nov 29 12:26:01 2004 From: pierchir@club-internet.fr (pierchir@club-internet.fr) Date: Mon Nov 29 12:26:01 2004 Subject: [Ip-health] =?iso-8859-1?Q?G=E9n=E9riques_antisida:_la_France_s'y_met_?= Message-ID: [ Converted text/html to text/plain ] Dear colleagues/friends, You should not be impressed by this announcement by the French MOH about the French translation of the 30 August WTO agreement. The current and still unofficial French proposal does not limit diseases and countries but gives the patent holder a 2 months long priority right over the generic producer after the latter has asked for a compulsory licence in France. Ii is a not a "generous" proposal but a real shame. Best Pierre Chirac MSF From gabi@ensp.fiocruz.br Mon Nov 29 13:09:03 2004 From: gabi@ensp.fiocruz.br (Gabriela) Date: Mon Nov 29 13:09:03 2004 Subject: [Ip-health] Patent Legislation Analysis in Latin America and the Caribbean Message-ID: <6.0.1.1.0.20041129155914.02fd3eb0@manguinhos.ensp.fiocruz.br> -- [ Picked text/plain from multipart/alternative ] Dear Members- In this month=92s Bulletin of the World Health Organization (Volume 82, Number 11, November 2004) an article was published on the analysis of industry property legislation for 11 countries from Latin America and the Caribbean. Based upon article 8 of the WTO TRIPS Agreement, which states that, =93Members may, in formulating or amending their laws and regulations, adop= t measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socioeconomic and technological development, provided that such measures are consistent with the provisions of this Agreement=94, the authors examined the industri= al property legislation to determine the main flexibilities that can favor the implementation of access to medicines policies. The countries examined were: Argentina; Bolivia, Brazil, Colombia, Ecuador, Honduras, M=E9xico, Peru, Venezuela, Dominican Republic; Panama. One specific case that the article discusses is the ARV price negotiations in 2001 in Brazil between private sector pharmaceutical companies and the Brazilian Ministry of Health. To access the full text, please click on the following link below: http://www.who.int/bu= lletin/volumes/82/11/en/815.pdf Sincerely, Gabriela Costa Chaves ***************************************** Center for Pharmaceutical Policies National School of Public Health Oswaldo Cruz Foundation Av Brasil, 4036, s/ 915 and 916 CEP 21040 361, Rio de Janeiro - RJ Brazil -- From joaninha@comcast.net Tue Nov 30 10:18:04 2004 From: joaninha@comcast.net (Joana Ramos) Date: Tue Nov 30 10:18:04 2004 Subject: [Ip-health] From the media: Generic Biotech Message-ID: <41AB66EA.8070801@comcast.net> Technology Review for December contains the article " Generic Biotech" by Erika Jonietz, available on-line at: http://www.techreview.com/articles/04/12/jonietz1204.asp there are links to a disucssion forum on the article, as well as to articles on various viewpoints on the topic. (Copied as fair use) Generic Biotech Biotech drugs can cost hundreds of thousands of dollars a year. Cheaper generic versions could save countless lives, but proving their safety and effectiveness is no easy task. By Erika Jonietz December 2004 Since their inception in the 1980s, biotech drugs based on natural proteins have come to mean the difference between life and death for millions of patients, treating diabetes, cancer, multiple sclerosis, heart attacks, and numerous genetic diseases. They boost the quality of life of millions more, people with conditions such as rheumatoid arthritis and Parkinson=92s disease. But such =93large molecule=94 drugs al= so come with large price tags. Interferon beta, used to treat multiple sclerosis, runs $10,000 to $14,000 a year. Cancer treatments such as Herceptin can cost $20,000 to $30,000. And the prices of drugs for some rare diseases can top $200,000 annually. =93People need these drugs for their survival,=94 says Abbey Meyers, founder and president of the National Organization for Rare Disorders. =93If they can=92t afford it, they=92re dead.=94 Click here to find out more! Patents on the first biotech drugs began expiring three years ago (see =93Some Would-Be Biogenerics=94), but the less-expensive generic versions that typically appear as soon as a drug loses patent protection have yet to hit the U.S. market. If you believe the arguments of pioneering biotech companies like Genentech and Amgen, the problem is the complexity of protein-based drugs=97or =93biologics=94=97which makes their duplication extraordinarily difficult. Without exact duplication, generics producers risk introducing drugs that may not work or could even harm patients. =93Anything can be reverse-engineered and copied,=94 Robert Garnick, Genentech=92s senior vice president for regulatory affairs, quality, and compliance, told a U.S. Food and Drug Administration panel in September. =93However, some things are much safer [to copy] than others.=94 But the fact is that several companies already sell generic versions of protein drugs in, for example, China and Latin America. The European Union is likely next. Such =93biogenerics=94 don=92t exist in the United States mainly because there is no mechanism for their approval and sale. The FDA has repeatedly delayed promised guidance on what sort of testing biogenerics will need to undergo to obtain approval; even if it does deliver guidelines, it might not have the legal authority to approve generic versions of many biotech drugs. And the biotech industry, of course, has already begun lobbying against biogenerics. But their time may nonetheless be ripe. As costs for biologic drugs rise, and the number of expired patents grows, patient groups, health-care payers, and generics manufacturers are pressing for change. Few patients can actually afford biologics, and even when insurers cover their costs, the drugs constitute an insupportable and growing burden on the health-care system. Medicare, for instance, spends an estimated $1 billion per year for erythropoietin, a protein used to treat anemia in cancer and kidney failure patients. Kaiser Permanente, the largest HMO in the United States, saw its expenditure on biologics more than triple between 1998 and 2003 and expects that figure to double again by the end of 2005. This situation, in which some patients=92 only hope is a ruinously expensive patented drug, was also characteristic of traditional =93small molecule=94 drugs until the advent of conventional generics=97and it helped earn the pharmaceutical industry a reputation for greed. =93The biotech industry, by and large, has been spared the negative public image that the pharmaceutical companies have acquired,=94 says MIT economist Ernst Berndt. =93The whole issue of generic entry is putting them in a very uncomfortable position that makes them look like big pharma.=94 A growing number of traditional generics makers and upstart biotech companies hope to paint exactly that picture of biotech pioneers. New technologies, they say, allow them to prove that their much cheaper copies of drugs are identical to the originals=97and just as safe and effective. Legislators and regulators are taking notice. In June, the U.S. Senate Judiciary Committee held hearings on the issue, and the FDA began a series of workshops in September designed to assess the risks inherent in biogenerics and the technologies available to mitigate them. Though the issues are complicated, more and more experts believe that U.S. patients will eventually have access to biogenerics. Some Would-Be Biogenerics Drug=09Condition Treated=09U.S. Patent expiration Insulin=09Diabetes=092001 Human growth hormone=09Short stature and muscle wasting associated with AIDS=092003 Interferon beta-1a=09Multiple sclerosis=092003 Erythropoietin=09Anemia associated with kidney dialysis or cancer treatment =092004 Alteplase=09Heart attack, stroke, blood clots in the lungs, and other conditions involving blood clots =092005 Filgrastim=09Low white-blood-cell count and risk of infection associated with cancer treatment=092006 The Protein Problem Would-be biogenerics makers face two major obstacles in the U.S. market. The larger of the two is the lack of a regulatory framework governing generic protein drugs. But this problem is bound up with the other: how to prove that a generic biologic is chemically and therapeutically equivalent to the original. For conventional pharmaceuticals such as aspirin, or even state-of-the-art drugs like Lipitor or Viagra, the process is straightforward. These drugs comprise relatively simple, small molecules that generics makers can synthesize directly in the lab and then analyze chemically to ensure that they are pure and identical to the name-brand versions. The FDA approves generics based on this proof, plus small clinical trials that typically include about 30 patients, to show that the body metabolizes the copies in the same way that it does the originals. Since generics companies don=92t have to conduct large and expensive clinical trials (or pay for the original R&D), they can sell the drugs cheaply and still turn a profit. Protein drugs, in contrast, are huge, complicated molecules. Chemists can=92t manufacture them cheaply, or in some cases at all, so biotech companies instead genetically engineer bacteria and other cells to do so. The reliance on living cells gives the process a black-box quality; small changes in, say, temperature or purification conditions can have unintended results, affecting how well a drug works or even causing severe side effects. Indeed, says Walter Moore, vice president of government affairs at Genentech, the firm that first produced recombinant insulin, =93our products are defined not by their chemical makeup but by the process through which they are made.=94 To some extent, the FDA seems to agree; the agency approves not only the finished product for biotech drugs but also the production process, which is often subject to separate patents or held as a trade secret. None of this, however, rules out copying protein drugs. Multiple patented versions of erythropoietin, insulin, human growth hormone, and interferon beta are sold in the United States. But each version varies slightly from the others and has gone through the full gamut of clinical testing required of a new drug=97a qualification that some biotech innovators insist every protein drug, unique or copy, should have to meet. =93This trade association would be uncomfortable with a process that didn=92t include clinical trials,=94 says Sara Radcliffe, managing director for science and regulatory affairs for the Biotechnology Industry Organization. Such a requirement would effectively bar generic competition. Emerging technologies, however, could improve the precision of protein characterization, helping to divorce biotech products from the processes used to make them=97and perhaps reducing the amount of clinical testing necessary. Generics companies such as Israel=92s Teva and GeneMedix in England, for instance, use ever improving analytical techniques and computational methods to accurately characterize the three-dimensional structures of proteins. Those structures=97the products of exceedingly complicated series of twists and folds as the proteins are being manufactured in the cell=97profoundly influence the molecules=92 efficacy, potency, and side effects. Startups such as Momenta Pharmaceuticals in the United States and U.K.-based Procognia have developed technologies to scrutinize another source of proteins=92 fickleness: the sugar molecules that are often attached to them during their manufacture. The enzymes in mammalian and human cells that add these sugars to proteins follow rules that seem to vary with the cells=92 growth conditions, so figuring out the number and types of sugars attached to a particular protein has proved especially challenging. Momenta has combined proprietary enzymes, traditional analytical techniques, and unique computational algorithms to precisely map such sugars. Procognia uses sugar-detecting arrays, analogous to gene chips that analyze gene sequences or activity, to do the same thing. =93From a technical standpoint, I believe it=92s possible to completely characterize a protein,=94 says Alan Crane, Momenta=92s CEO. =93= If you can show it=92s all the same, what are the arguments for not allowing a generic?=94 Biogeneric Bureaucracy Technical arguments aside, many contend that the FDA doesn=92t even have the authority to approve most biogenerics. When U.S. generic-drug laws were passed in the 1980s, the brand new, complex biotech drugs were not under discussion. =93At the time they were debating, it didn=92t occur to anyone that technology would advance to the point it would be possible to create generic biologics,=94 says Janice Reichert, a senior research fellow at the Tufts Center for the Study of Drug Development. As a result, existing generics legislation applies only to small-molecule drugs, not biologics. During a 2003 push to improve patient access to drugs, the FDA announced plans to issue guidelines that would begin to define an approval process for generic protein drugs, but they have so far been delayed twice=97perhaps because of the agency=92s uncertainty over its legal position. Even those guidelines, regulators have indicated, would apply only to a few biologics: relatively simple, well-defined proteins such as human growth hormone and insulin. (In fact, Sandoz, the generics arm of Swiss drug company Novartis, has already submitted an application for a generic version of human growth hormone in the belief that the FDA has the authority to approve it.) The easiest solution would be an extension of existing generics laws to cover all protein-based drugs, and Senators Orrin Hatch and Patrick Leahy seem primed to take that action. The pair sponsored hearings on biogenerics within the Senate Judiciary Committee in June, and Leahy=92s staffers say he hopes to introduce legislation in 2005 that would apply the framework for small-molecule generics to biologics. Biotech companies will inevitably fight such legislation, just as traditional drugmakers opposed the advent of small-molecule generics. Many of the current arguments parallel those made two decades ago. Companies assert, for instance, that copycat proteins will cut into revenues so severely that the expensive research needed to develop new lifesaving drugs will slow or even halt. The pace of innovation in small-molecule drugs, however, suffered no such deceleration. Indeed, generics have forced pharmaceutical companies to develop improvements, such as time-release or longer-acting formulations, in an effort to maintain market share. In the meantime, the FDA has begun a series of public workshops designed to assess the available technology and get feedback from stakeholders. The first session, held in September and designed to help regulators assess scientific arguments, became a highly polarized back-and-forth between biotech pioneers and biogenerics makers. The agency has so far remained silent about the form any rules might take and has planned a second workshop for early 2005. But even when biogenerics do appear in the United States, patients and insurers might not see the same cost savings they have with traditional generics. =93The prices may not go down as much,=94 says Momenta=92s Crane, =93because the hurdles are higher in the first place.=94 The lower prices o= f generic drugs=97typically 50 to 66 percent those of the originals=97stem from their abbreviated approval process and from the fact that many states mandate generic substitution at pharmacies, so manufacturers can dispense with costly marketing. Biogenerics will almost certainly face stricter preapproval testing requirements than small-molecule generics, at least until the FDA gains confidence that copycat proteins can be analyzed well enough to prove that they are identical to the originals. And most biologics are administered in hospitals rather than dispensed at pharmacies; since generics companies may face an uphil