From owner-pharm-policy@venice.essential.org Mon Dec 20 11:01:17 1999 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by venice.essential.org (Postfix) with ESMTP id 82BF821B0D; Mon, 20 Dec 1999 11:01:17 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by milan.essential.org (8.9.3/8.9.3) with ESMTP id LAA29485; Mon, 20 Dec 1999 11:01:19 -0500 Date: Mon, 20 Dec 1999 11:01:19 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: ip-health@venice.essential.org, pharm-policy@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] Pascale Boulet on TRIPS Transition in Thailand According to Pascale Boulet, because Thailand had product patents in place in January 1995, it is not required to provide 70.9 exclusive marketing rights. Jamie --------------- >From bouletp@who.ch Mon Dec 20 08:57:43 1999 Date: Fri, 17 Dec 1999 16:34:08 +0100 From: bouletp@who.ch To: love@cptech.org Subject: Re:More on the 5 year marketing exclusivity and Nevirapine i I think that the TRIPS provision on exclusive marketing rights (art.70.9) only applies to developing and least developed countries that did not provide patent protection for pharmaceutical products in January 1995 (entry into force of the WTO Agreement). I think this provision, as well as the "mail-box" system was included, so that pharmaceutical products can be protected as from 1995 even in these countries. This was necessary because these countries do not have to grant pharmaceutical patents until 2005 or 2006. The mail-box system allows pharmaceutical companies to file patent applications for pharmaceuticals since 1995 in countries where the patent law has not yet been put in line with TRIPS. These applications will be examined at the end of the transitionnal periods (2005, 2006) and granted for the remaining time of the 20-year patent term, starting at the date of the patent application. If a new pharmaceutical is given market authorization in Country A but the patent application for this drug in Country A is still pending in the mail-box, then the manufacturer of this pharmaceutical may be granted exclusive marketing rights in Country A, but only if a patent was granted and a market authorization given for the same drug in another WTO Member country after 1995. Therefore, this cannot apply in Thailand because patent protection for pharmaceutical products was introduced in Thailand in 1992. Therefore, TRIPS Articles 70.8 and 70.9 do not apply in Thailand. There was no need for a mail-box system since patent protection was available in 1995. If there is some sort of market exclusivity for Nevirapine in Thailand, it is probably due to the Safety Monitoring Programme (SMP) run by the Thai Food and Drug Administration, but not in relation to TRIPS Article 70.9. Therefore, the market exclusivity over nevirapine should cease as soon as the FDA release it from the SMP. Moreover, it would be surprising if a patent application was pending for the protection of nevirapine as a product, since the first US patent application dates back to 1989, before the revision of the Thai Patent Act in 1992. If this is the case, generic competition could start as soon as nevirapine is released from the SMP, without any need for compulsory licensing. Hoping this is understandable. Pascale From owner-pharm-policy@venice.essential.org Mon Dec 20 17:35:25 1999 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 96DF521BB7 for ; Mon, 20 Dec 1999 17:35:25 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id RAA23073; Mon, 20 Dec 1999 17:35:30 -0500 Sender: jl@genoa.essential.org Message-ID: <385EB207.547D30E1@cptech.org> Date: Mon, 20 Dec 1999 17:47:35 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.51 [en] (X11; I; Linux 2.2.5-15 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Dominican Republic I believe today, there were some articles in the Dominican Republic press regarding the proposed changes in patent law. One article is basically a press release or interview of Rodney Lopez, apparently the head of the domestic PhRMA type organization, called de la Asociacion de Empresas Farmaceuticas de Investigacion y Desarrollo (EFID). The other article concerns a press release issued by El Consejo Nacional de la Empresa Privada (CONEP). Both articles appeared in El Dinero, and are in spanish, which I can't read. I'd be happy to fax them to someone who can. According to Virgilio Mota of the Dominican Republic Embassy (in Washington, DC), the patent law is very controversial in the Dominican Republic right now, and there may be action before the end of this year (the TRIPS deadline). We tried to get some information for USTR, STATE and US PTO about the US government's policy on this, but no one would give us a single document, or even acknowledge what documents exist. But both US and Dominican Republic officials acknowledge the US has been very active in this dispute. We are going to continue to try to get some information on this. Jamie -- James Love / Director, Consumer Project on Technology http://www.cptech.org / love@cptech.org P.O. Box 19367, Washington, DC 20036 voice 202.387.8030 / fax 202.234.5176 From owner-pharm-policy@venice.essential.org Tue Dec 21 10:58:30 1999 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id E353921B19 for ; Tue, 21 Dec 1999 10:58:29 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id KAA31210 for ; Tue, 21 Dec 1999 10:58:31 -0500 Sender: jl@genoa.essential.org Message-ID: <385FB162.24CC575@cptech.org> Date: Tue, 21 Dec 1999 11:57:06 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.51 [en] (X11; I; Linux 2.2.5-15 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] THAI ACTIVISTS DEMONSTRATING FOR THE USE OF COMPULSORY LICENSE OUTSIDE THE MINISTRY OF PUBLIC HEALTH IN BANGKOK Date: Tue, 21 Dec 1999 22:33:30 +0700 From: "MSF-Drugs Bangkok" THAI ACTIVISTS DEMONSTRATING FOR THE USE OF COMPULSORY LICENSE OUTSIDE THE MINISTRY OF PUBLIC HEALTH IN BANGKOK The Thai Network for People Living with HIV/AIDS and supporting NGO's will start a several day demonstration outside the Ministry of Public Health on Wednesday, December 22, 1999 to demand the use of compulsory license for ddI. More than a month ago the Thai Government Pharmaceutical Organization (GPO) asked for the use of compulsory license for ddI; we are still waiting for a result. The PHA Network and NGO's have met twice with Public Health Minister, Korn Dabaransi to ask for the use of compulsory license according to section 51 of the Thai patent law or as a minimum to negotiate a voluntary license with Bristol Myers Squibb. The Public Health Minister suggested that compulsory license should only be used if Bristol Myers Squibb will not reduce the price significantly until the end of this month. Apparently there have been no attempts to even negotiate a voluntary license. Activists will not agree to a mere price reduction by Bristol Myers Squibb because only generic production can garantee that the price will drop further every time the raw material becomes cheaper. Following the statement by President Clinton in Seattle on trade policy and medicines, the Thai government should now act decisively on the issue of HIV drugs. Participating NGO's: Thai Network for People Living with HIV/AIDS; ACCESS; Alden House; Siam Care; CLIST; MSF; Care; Empower; Power of Life; Pilapkao Group; Friends of AIDS Group; Human Rights for AIDS; Consumer Foundation and others Below a report by Reuters that gives a good background on the current situation of ddI in Thailand THAIS URGED TO STAND UP TO AIDS DRUG FIRM By David Brunnstrom BANGKOK, Dec 15 (Reuters) - Medical activists are urging Thailand to take a stand against drug multinationals by licensing the local manufacture of a crucial AIDS drug that could let hundreds of thousands live longer if they could afford it. They say Bangkok should be emboldened to take the unprecedented step over the drug didanosine (ddI) after U.S. President Bill Clinton said Washington would alter trade policy to support greater worldwide access to life-saving medicines. However, the activists believe Thailand, like other developing countries struggling with the AIDS epidemic, will be unwilling to take the radical step of imposing ``compulsory licensing'' allowed under world trade rules, fearing retaliation. They say Washington has put pressure on Thailand in the past by threatening higher tariffs on Thai imports. ``The U.S. government is constantly bullying countries that attempt to pass laws to make medicines more affordable,'' James Love, director of the U.S. Consumer Project on Technology, said in a statement in response to Clinton's December 1 announcement. ``If Clinton is to be taken seriously, we'll have to see something concrete. For example, the U.S. could signal to Thailand it can proceed with compulsory licences for ddI ... that was invented by the U.S. government but sold at high prices by Bristol-Myers Squibb.'' Activists see continuing talks between the Thai government and Bristol-Myers Squibb (BMS) on ddI as a test case that could have profound implications for developing nations in the new trade round. ``EXTENDING AND ENHANCING HUMAN LIFE'' The U.S. drug giant, dedicated according to its motto, to ``Extending and Enhancing Human Life,'' boasts on its website http://www.bms.com of subsidising drug therapy in clinical trials in Thailand ``because of the large potential market of more than one million people infected with AIDS.'' It sells ddI in Thailand under the name Videx at about 49 baht ($1.25) a capsule, far beyond the means of most Thais infected with the human immunodeficiency virus, or HIV, which causes AIDS, acquired immune deficiency syndrome. Current pricing means people in a country where the minimum monthly wage is just 5,400 baht ($138) must pay up to 8,000 baht ($205) a month for a two-drug anti-retroviral cocktail. The bulk of the cost is for ddI, since Thailand's Government Pharmaceutical Organisation (GPO) began producing the other drug -- AZT, or zidovudine -- in 1995 at about a quarter of the price of the imported version. Krisana Kraisintu, head of research and development at the GPO, says she could produce ddI for 25 baht a capsule if local production were permitted. ``More HIV-infected people could have access to it if we were to manufacture it,'' she told Reuters. ``Now only five percent of the HIV-infected people can have access to the drug. If I can cut the price to half, maybe up to 10 percent can have access.'' Officials at Bristol-Myers Squibb in Thailand were unavailable for comment, but Thai media reports and activists say the firm aims to head off compulsory licensing by offering ddI in Thailand at a steep discount. Nobel Peace Prize-winning non-governmental organisation Medecins sans Frontieres (MSF), which is spearheading a global campaign to ensure ddI and other essential drugs reach those who need them, says this is not an answer and a stand should be made. Compulsory licensing would allow the local production of cheap, generic versions of the drug on payment of a royalty. Activists say drug companies are not only worried about a drop in profits in the country concerned but that if one developing country were to take the step, others would follow. THAI CASE IMPORTANT FOR COMPANY MSF says the argument drug firms make -- that the big profits they pile up are needed for research -- is especially spurious in ddI's case since it was developed with U.S. taxpayers' money. It says the best solution would be for the firms to grant voluntary licences for production of key drugs in developing countries. ``For Bristol-Myers Squibb, something important is at stake: the first use of a compulsory licence in a developing country,'' said Tido Von Schoen-Angerer, of MSF's Bangkok office. ``They will accept major price reductions if they can avoid the use of a compulsory licence in Thailand.'' A senior official of the Thai Commerce Ministry's Department of Intellectual Property said it would seek a compulsory licence for ddI only if talks between the GPO and Bristol-Myers Squibb failed. The official, who did not want to be named, said Thai law allowed compulsory licensing only in a ``national emergency.'' ``But nobody has talked about that. Many things in the country might be more serious -- like the economic crisis, or something like that,'' he said. Von Schoen-Angerer said Thailand's apparent leaning towards a compromise solution was a disappointment. While the GPO would only achieve a 50 percent reduction in price initially if it were to produce the drug generically -- a price BMS could probably match -- further cuts would likely be possible within a short time, he said. Chaiyos Kunanusont, director of the Health Ministry's AIDS division, said Thailand should bite the bullet in the interests of the future and not opt for an easier, short-term solution. "In the long term we want to manufacture some drugs -- not all of them, but some of them, in order to make ourselves independent of the monopoly activities of the drug companies. ``We are not draining all the wealth from the drug company -- we just ask for exemption on a group of medication. They can make money on many other drugs, but these are life-saving drugs.'' For the NGO Network: MSF Thailand msfdrugs@asianet.co.th -- James Love / Director, Consumer Project on Technology http://www.cptech.org / love@cptech.org P.O. Box 19367, Washington, DC 20036 voice 202.387.8030 / fax 202.234.5176 From owner-pharm-policy@venice.essential.org Tue Dec 21 22:11:01 1999 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by venice.essential.org (Postfix) with ESMTP id F0E5921B12; Tue, 21 Dec 1999 22:11:00 -0500 (EST) Received: from cptech.org (ppp-6.essential.org [216.0.125.6]) by milan.essential.org (8.9.3/8.9.3) with ESMTP id WAA03122; Tue, 21 Dec 1999 22:11:05 -0500 Sender: jamie@milan.essential.org Message-ID: <386040B7.1026701D@cptech.org> Date: Tue, 21 Dec 1999 22:08:39 -0500 From: James Love X-Mailer: Mozilla 4.07 [en] (X11; I; Linux 2.0.36 i586) MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] HIV/AIDS/Trade Policy section of Africa Trade bill This is the current version of the language passed by the Senate on the African trade bill that deals with HIV/AIDS. The bill is H.R.434, the Trade and Development Act of 1999 (Engrossed Senate Amendment). The relevant section is 116. The bill has passed both the House and the Senate, and is now in Conference. The Senate conferees are: Roth; Grassley; Lott; Helms; Moynihan; Baucus and Biden. I'm not sure who the House conferees are. Earlier I had posted a note that was based upon a fax we received from the Senate, that contained items that were apparently rejected. The language that passed is considerly better than what I had thought had passed. One of the items on the fax was a PhRMA proposal that did not get included in the legislation. This wasn't clear at the time. Rob, Thiru and I were invited to meet with a Senate staffer today, and we learned a little about the status of the amendment. It seems that PhRMA and its member companies think they can get the House members to take Section 116 out of the bill. The key section is (c), which limits the use of public funds, and while it could be improved, it isn't bad. Senator Roth's position will be pretty important, as he is Chair of the Senate Finance Committee, where the trade bills are considered, and he was the chief sponsor of the Senate version of the African trade bill. Roth is also apparently in a tough reelection campaign in Delaware. Senator Moynihan, who is retiring, is the ranking Democrat on the Finance Committee. Apparently he (his staff) was hostile to the amendment, which isn't good news. Note that Lott and Helms are also Senate conferees. However, there is considerable support for the amendment in the Senate, particularly given the increased news coverage of the African AIDS crisis. Jamie ---------------------- http://thomas.loc.gov/cgi-bin/bdquery/z?d106:HR00434: H.R. 434 SEC. 116. ACCESS TO HIV/AIDS PHARMACEUTICALS AND MEDICAL TECHNOLOGIES. (a) FINDINGS- Congress finds that-- (1) since the onset of the worldwide HIV/AIDS epidemic, approximately 34,000,000 people living in sub-Saharan Africa have been infected with the disease; (2) of those infected, approximately 11,500,000 have died; and (3) the deaths represent 83 percent of the total HIV/AIDS-related deaths worldwide. (b) SENSE OF CONGRESS- It is the sense of Congress that-- (1) it is in the interest of the United States to take all necessary steps to prevent further spread of infectious disease, particularly HIV/AIDS; (2) there is critical need for effective incentives to develop new pharmaceuticals, vaccines, and therapies to combat the HIV/AIDS crisis, especially effective global standards for protecting pharmaceutical and medical innovation; (3) the overriding priority for responding to the crisis on HIV/AIDS in sub-Saharan Africa should be the development of the infrastructure necessary to deliver adequate health care services, and of public education to prevent transmission and infection, rather than legal standards issues; and (4) individual countries should have the ability to determine the availability of pharmaceuticals and health care for their citizens in general, and particularly with respect to the HIV/AIDS epidemic. (c) LIMITATION ON USE OF FUNDS- Funds appropriated or otherwise made available to any department or agency of the United States may not be obligated or expended to seek, through negotiation or otherwise, the revocation or revision of any intellectual property or competition law or policy that regulates HIV/AIDS pharmaceuticals or medical technologies of a beneficiary sub-Saharan African country if the law or policy promotes access to HIV/AIDS pharmaceuticals or medical technologies and the law or policy of the country provides adequate and effective intellectual property protection consistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights referred to in section 101(d)(15) of the Uruguay Round Agreements Act. -- James Love Consumer Project on Technology http://www.cptech.org love@cptech.org 202.387.8030; fax 202.234.5176 From owner-pharm-policy@venice.essential.org Wed Dec 22 11:46:14 1999 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id BAD4921B07; Wed, 22 Dec 1999 11:46:13 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id LAA13182; Wed, 22 Dec 1999 11:46:16 -0500 Sender: jl@genoa.essential.org Message-ID: <38610E1D.ACB0BFCF@cptech.org> Date: Wed, 22 Dec 1999 12:45:01 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.51 [en] (X11; I; Linux 2.2.5-15 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Thais protest U.S. firm's AIDS drug monopoly http://biz.yahoo.com/rf/991222/bq.html Wednesday December 22, 2:19 am Eastern Time Thais protest U.S. firm's AIDS drug monopoly By Sutin Wannabovorn BANGKOK, Dec 22 (Reuters) - Representatives of the estimated one million Thais infected with HIV set up camp outside Thailand's Health Ministry on Wednesday to demand that the government break a U.S. drug firm's monopoly on an AIDS drug. About 100 protesters, wearing yellow T-shirts, called on the government to issue a compulsory licence to allow cheap local production of the drug didanosine which is produced and marketed by U.S. drug giant Bristol-Myers Squibb (NYSE:BMY - news). They erected tents and vowed to continue their protest around the clock until Friday. ``We are demanding the government impose a compulsory licence to give the Public Health Ministry the right to produce the essential drug didanosine,'' said Paisal Tanhood, chairman of the HIV Infection Network, which has more than 20,000 members. Didanosine, also known as ddI, is one of a two-drug anti-retroviral cocktail prescribed for Thais with HIV to help them live longer. But campaigners say the vast majority of those infected cannot afford the treatment because of the high price of ddI. Thailand's Government Pharmaceutical Organisation (GPO) began producing the other drug -- AZT, or zidovudine -- in 1995 at about a quarter of the price of the imported version. Compulsory licensing would allow the local production didanosine on payment of a royalty, but no developing country has yet taken the radical step, fearing trade retaliation by the United States to protect the interests of drug companies. DRUG TOO EXPENSIVE FOR MOST THAIS In Thailand, ddI costs about 49 baht ($1.25) per tablet, putting the monthly cost of the two-drug cocktail in a country where the minimum monthly wage is 5,400 ($138), at about 8,000 baht ($205). Activists say Bristol-Myers has offered to cut ddI's price, but not to the extent local production would eventually allow. A ministry spokesman said talks were continuing between the GPO and Bristol-Myers but he declined to elaborate. Bristol-Myers officials were not available for comment on the licensing issue. Paisal, 34, who was diagnosed HIV positive eight years ago, told Reuters he was unable to afford ddI, but his wife was using it free under a trial programme at a government hospital. ``Only five percent of about one million people with HIV have access to ddI because it's so expensive, so cutting the price a bit is not a good solution for under-privileged people,'' he said. Activists said making ddI in Thailand was the best solution, but they doubted the government would be bold enough to stand up to the threat of U.S. pressure. ``DdI is the hope for those with HIV, but I don't think Thailand will dare take the radical action in colliding head-on with the United States because of the fear of trade retaliation,'' Saree Aongsomwang of the Foundation for Consumers, told Reuters. International pressure groups, including the 1999 Nobel Peace Prize winning aid group Medicins Sans Frontiers (Doctors Without Borders), have been urging Thailand to make a stand on the issue. They say Bangkok should be emboldened after U.S. President Bill Clinton pledged on World AIDS Day on December 1 a change in U.S. trade policy to support greater worldwide access to lifesaving medicines. -- James Love / Director, Consumer Project on Technology http://www.cptech.org / love@cptech.org P.O. Box 19367, Washington, DC 20036 voice 202.387.8030 / fax 202.234.5176 From owner-pharm-policy@venice.essential.org Wed Dec 22 10:48:59 1999 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 4721121B7B; Wed, 22 Dec 1999 10:48:59 -0500 (EST) Received: from cptech.org (fluid.essential.org [216.0.124.57]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id KAA12352; Wed, 22 Dec 1999 10:49:01 -0500 Sender: tb@genoa.essential.org Message-ID: <3860F339.B331AED8@cptech.org> Date: Wed, 22 Dec 1999 10:50:17 -0500 From: Thiru Balasubramaniam Organization: Consumer Project on Technology X-Mailer: Mozilla 4.51 [en] (X11; I; Linux 2.2.5-15 i686) X-Accept-Language: en MIME-Version: 1.0 To: Multiple recipients of list IP-HEALTH , Multiple recipients of list PHARM-POLICY Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] DS 114 A reader kindly provided the url for a Canadian government website on Dispute Settlement Cases. This particular page refers to DS 114 regarding the EU's complaint against Canada regarding Canada's early working and stockpiling provisions for generic versions of patented pharmaceuticals. http://www.dfait-maeci.gc.ca/tna-nac/summary-e.asp Thiru From owner-pharm-policy@venice.essential.org Wed Dec 22 12:49:31 1999 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 7211421B3A; Wed, 22 Dec 1999 12:49:31 -0500 (EST) Received: from cptech.org (fluid.essential.org [216.0.124.57]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id MAA14200; Wed, 22 Dec 1999 12:49:34 -0500 Sender: tb@genoa.essential.org Message-ID: <38610F79.CA8641C6@cptech.org> Date: Wed, 22 Dec 1999 12:50:49 -0500 From: Thiru Balasubramaniam Organization: Consumer Project on Technology X-Mailer: Mozilla 4.51 [en] (X11; I; Linux 2.2.5-15 i686) X-Accept-Language: en MIME-Version: 1.0 To: Multiple recipients of list IP-HEALTH , Multiple recipients of list PHARM-POLICY , Multiple recipients of list Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Submission for Canada (DS 114) http://www.dfait-maeci.gc.ca/tna-nac/summary-e.asp Panel Cases to which Canada is a Party WTO Canada - Patent Protection of Pharmaceutical Products Submission for Canada 1.In these proceedings, the European Communities and their Member States (hereinafter the EU) contend that two provisions of Canada's Patent Act do not conform with the requirements of the Agreement on Trade-Related Intellectual Property Rights (TRIPS). The provisions in issue stipulate that it is not an infringement of a patent for a person, not having the consent of the patent owner, to make, construct, use or sell the patented invention a.solely for uses reasonably related to the development and submission of information required under any law that regulates the manufacture, construction, use or sale of a product (subsection 55.2(1) of the Patent Act), or b.during a limited, prescribed period immediately preceding the expiry of the patent, for the manufacture and storage of articles intended for sale after the patent expires (subsection 55.2(2) of the Patent Act). 2.The essential question is whether these two provisions are "limited exceptions to the exclusive rights conferred by a patent", within the meaning of Article 30 of TRIPS. 3.It is Canada's submission that these two measures a.are "limited exceptions" within the meaning of Article 30, since they allow patent owners complete freedom to exploit their rights throughout the full term of patent protection, leaving the monopoly of commercial exploitation and the exclusivity of economic benefits unimpaired for the life of the patent; b.do not conflict with a normal exploitation of a patent or prejudice the legitimate interests of the patent owner, since they only affect the patent owner's commercial exploitation after the patent has expired; c.in any event, take into account Canada's national interest in measures conducive to social welfare and the achievement of a balance between rights and obligations, both of which are recognized objectives in Article 7; and d.in particular, as required by Article 30, take account of the legitimate interests of third parties, in that: i.they allow potential competitors to compete freely with the patentee after the patent expires, consistent with the policy of full competition underlying Article 29's requirement that, in return for the grant of patent protection, patentees must disclose their inventions to the public; Article 33's provision that the exclusive rights be conferred for a specified term only; and Article 40's authorization of national measures to prevent abuse of intellectual property rights having an adverse effect on competition; and ii.they seek to protect public health -- a value recognized in Article 8.1 -- through promoting access to cost-effective generic medicines following patent expiry, and in this connection they take into account the legitimate interests of individuals, private insurers and public sector entities that finance health care in maintaining access to affordable medicines. 4.Article 30 allows uses that do not unreasonably conflict with a normal exploitation of the patent or unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties. Canada submits that Article 30 therefore authorizes measures that limit exclusive rights, provided that no commercial exploitation -- i.e., sales -- take place during the patent term. Any other interpretation would: a.ignore the existence of the word "unreasonably" in Article 30 and thereby the fact that conflict with normal exploitation and prejudice to the patent owner's interests are allowed; b.disregard the public policy principles inherent in Articles 29 and 33, which encourage free and open competition with the patent owner immediately upon expiry of the patent; and c.as a consequence, promote the practice of enforcing patent rights within the patent term so as to extend the monopoly of the patent owner beyond the term, a policy which the EU sought to have included in the Agreement but which was not so included, i.e., as the EU makes plain in paragraph 41 of its First Submission, it seeks to win through litigation the windfall period of protection that it could not secure by negotiation. 5.Canada's submission is based on the interpretative rule set out in Article 31 of the Vienna Convention on the Law of Treaties that the terms of any international treaty, including TRIPS, are to be interpreted in good faith in accordance with their ordinary meaning in their context and in light of the object and purpose of the treaty. When the exception provisions in Part II of the TRIPS Agreement are interpreted in accordance with this rule, it becomes apparent that Article 30 provides a general and flexible authority for Members to adopt measures that balance the interests of patent owners with the interests of others, as Article 7 expressly states is an objective of TRIPS. 6.The language of Article 30 is markedly different from other provisions which allow exceptions to treaty rights. For example, GATT 1994, Article XX, requires -- as in paragraph (b) -- that the exception measures be necessary to protect human health, and it contains additional restrictions in its chapeau portion. No similar restrictions are required under Article 30. Similarly, TRIPS Article 13 (and Article 9(2) of the Berne Convention for the Protection of Literary and Artistic Works (1971), upon which the latter was modelled), does not allow conflict with a normal exploitation of the work. 7.Thus, TRIPS contemplates that Members may, in implementing their obligations within their legal systems, adopt measures which, like those in issue here, introduce limited exceptions to the exclusive rights conferred by a patent and confine the patent monopoly to the specific term for which it is granted, in the interests of promoting full competition in regulated-product markets after the expiry of that term and of realizing the cost-saving benefits that competition in those markets (particularly the health care products market) confers on society. TRIPS does not contemplate that these important societal interests should be overridden by an alleged right of patentees to exploit time-consuming regulatory review systems -- which are neither designed nor intended to protect intellectual property rights -- in order to extend the term of patent protection and to gain a windfall monopoly. 8.Equally, TRIPS does not contemplate that these important societal interests should be overridden by the anti-discrimination requirement of Article 27.1. The latter provision is not intended to require "across the board" derogations from patent rights. That would only defeat Article 30's purpose of permitting exceptions that are "limited", and would compel the application of exceptions where they are not needed. Instead, since Article 27.1 does not purport to define the "patent rights" that it requires to be made available and enjoyable without discrimination, those rights are the ones enumerated in Article 28.1, subject to any exception that may be made under Article 30, 31 or 40. This interpretation gives effect to the language of Article 27.1 in its context rather than in isolation, and achieves the balance contemplated by Article 7 as an objective of the TRIPS Agreement. From owner-pharm-policy@venice.essential.org Thu Jan 6 11:29:50 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id C1D1A21B2E; Thu, 6 Jan 2000 11:29:50 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id LAA23077; Thu, 6 Jan 2000 11:29:50 -0500 Sender: jamie@genoa.essential.org Message-ID: <3874C29D.82AF7A43@cptech.org> Date: Thu, 06 Jan 2000 11:28:13 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] SA/Germany March 10, 1998 Cape Town meeting on SA Medicines Act Rob Weissman has received under the US FOIA a cable from the Department of State that describes a March 10, 1998 meeting between German President Roman Herzog and then South Africa Deputy President Thabo Mbeki, regarding intellectual property rights. The cable appears to have been based largely upon a March 11, 1998 report in Business Day, a South African publication. http://www.bday.co.za/98/0311/news/n11.htm This isn't much information in the cable or the Business Day story, other than the fact that Herzog raised the issue of patent protection for pharmaceuticals with Mbeki, and Herzog said he was "greatly reasuured" by what Mbeki said. The German intervention had been mentioned in a Feb 5, 1999 US Department of State report on the South African Medicines Act, but this cable gave us the date and a pointer to the Bday story. Jamie -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Thu Jan 6 12:36:01 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 530F121B8A; Thu, 6 Jan 2000 12:36:01 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id MAA24456; Thu, 6 Jan 2000 12:36:01 -0500 Sender: jamie@genoa.essential.org Message-ID: <3874D220.9AD7A684@cptech.org> Date: Thu, 06 Jan 2000 12:34:24 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy , healthgap Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Today's WP editorial This is the editorial from Today's Washington Post. Among other things, it fairly closely follows the big PhrMA talking points and PR efforts. A few points, - The statement that "Last year the pharmaceutical industry allowed firms in South Africa to distribute cheaper copies of their products," is completely false. - The statement on the poor developing country infrastruture overlooks the cases where the infrastructure does exist (why are't drugs cheap in Thailand? for example), or where compliance and infrastructure issues are not as severe (i.e. fluconazole). - The reference to the Sach's proposal for funding a market for vacinnes ignores some other models, such as public funding of the research, and it does not address the important issue of who gets the intellectual property rights from a multi billion public investment. No mention at all is made of US trade policy -- as if this was never an issue fit for public debate, despite current disputes in Thailand, Philippines, Dominican Republic and many other countries over IPR issues. jamie Editorial from today's Washington Post. Fighting AIDS Thursday, January 6, 2000; Page A18 NEXT MONDAY the United Nations Security Council will, for the first time in its history, convene to discuss action on a health issue. Also for the first time, the meeting will be chaired by an American vice president. The health issue in question is the spread of the HIV virus: Since AIDS, the disease to which the virus leads, is killing far more people than war, it richly deserves the Security Council's attention. The question is what to do about it. The first answer is to resist the temptation to place excessive hope in the wonder drugs that have cut mortality from AIDS in rich countries. These drugs cost around $20,000 per person per year; many of the poor countries that bear the brunt of AIDS have annual health budgets of less than $20 per person. There have been welcome efforts to reduce the cost of treatment: Last year the pharmaceutical industry allowed firms in South Africa to distribute cheaper copies of their products. But even if the cost of treatment could be radically reduced, it would remain impractical in much of the developing world. Anti-HIV drugs need to be administered with a precision that rudimentary health infrastructures cannot aspire to. The second answer is to invest in the development of a cheap, easily delivered vaccine--but not to expect a quick victory. Even if a vaccine were discovered tomorrow, its efficacy could not be known until it is tested; and tests involve monitoring large groups of people over extended periods. There are plans afoot for the world's eight leading countries to promise $500 million each toward the future cost of delivering a vaccine to the poor world: This would give the drug companies a powerful incentive to come up with one. But that excellent scheme cannot save the millions likely to become infected over the next half-decade. In sub-Saharan Africa, 10 people are infected every minute. Since science is unlikely to provide a silver bullet in the medium term, there is no option but to change human behavior. That sounds like a hopeless task: There have been calls for safe sex in the developing world for more than a decade, and yet the epidemic has progressed monstrously. But changing behavior is not in fact impossible. The countries that have tried it seriously have managed. Thailand, for example, has succeeded in getting prostitutes to insist on condoms. Senegal has kept the incidence of HIV infection below 2 percent. Uganda's education campaign, focusing both on values and on practical information, has persuaded its youth to delay the first sexual experience by an average of two years; the infection rate among pregnant women in towns fell from 37 percent to around 15 percent during the 1990s. Other developing countries need to follow this example. To do this, they need to go beyond spreading the simple facts of the disease: Study after study in Africa has found that people know about AIDS but still do not change their behavior. In order to make progress, governments need to fight the presumption that multiple sexual conquests are a mark of manly virtue: They could begin by prosecuting rapists seriously, including the many teachers who routinely have sex with their pupils. At the same time, governments need to treat decently those who are infected, so that the stigma of AIDS weakens. So long as that stigma persists, people will not admit to having the disease, and so will continue to spread it. This set of policies will be expensive. The humane treatment of sufferers is a monumental task in regions such as southern Africa, where one in four adults are thought to carry HIV. In his speech before the Security Council next week, Vice President Al Gore will do the world a service by focusing attention on this era's plague. But he should also spur the developed world to give more aid to developing countries with serious AIDS policies. At present, the United States spends nearly $900 million a year on fighting the disease within the United States, and the problem here is far from solved. All the sub-Saharan countries combined have a mere $160 million to spend on their efforts--and the challenge they face is much, much bigger. -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Thu Jan 6 13:17:59 2000 Return-Path: Delivered-To: pharm-policy@lists.essential.org Received: from cptech.org (jamie.essential.org [216.0.124.36]) by venice.essential.org (Postfix) with ESMTP id 26BC521B0B; Thu, 6 Jan 2000 13:17:59 -0500 (EST) Sender: jamie@venice.essential.org Message-ID: <3874DBF7.962EFBD4@cptech.org> Date: Thu, 06 Jan 2000 13:16:23 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Cc: "Dr. Thomas Novotny" Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Getting information on US policy from agencies Some US federal trade officials have complained about the burden of responding to requests for information under the US federal freedom of information act (FOIA). Recently we tried to work more informally with federal trade officials to find out the basis for US government trade pressures on the Dominican Republic over its proposed changes to its patent laws. We contacted the US Department of State, the USTR and the US Patent and Trademark Office, asking all three agencies to provide us with information about US policy in this dispute, including, for example, copies of the DR proposal (in any language) and or any US analysis of the proposal. There is, after all, an official 301 watch list entry for the DR on this issue. Our agency contact was repeated, persistent, and involved telephone calls with officials who are working directly on this issue. So far we have yet to receive even a single document from any of the three federal agencies. So, in order to find out the basis for US foriegn policy, we will have to file FOIA requests and wait several months for documents. We intend to ask Dr. Thomas Novotny at DHHS if he can ask federal agencies to be more forthcoming with information on these disputes. Jamie -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Thu Jan 6 14:26:19 2000 Return-Path: Delivered-To: pharm-policy@lists.essential.org Received: from cptech.org (jamie.essential.org [216.0.124.36]) by venice.essential.org (Postfix) with ESMTP id D238C21B0B; Thu, 6 Jan 2000 14:26:18 -0500 (EST) Sender: jamie@venice.essential.org Message-ID: <3874EBFB.9F1AF17B@cptech.org> Date: Thu, 06 Jan 2000 14:24:43 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] letter to Dr. Novotny regarding empirical basis for trade policy This is a letter we sent to Dr. Thomas Novotny, asking that DHHS provide an empirical basis for the claims that HIV/AIDS drugs require $.5 billion to develop. ------------------------ January 6, 2000 Empirical basis for review of US trade policy Dr. Thomas Novotny TNovotny@OSOPHS.DHHS.GOV Dear Dr. Novotny, This is a letter asking for information regarding the empirical basis for reviews of US trade policy, as it relates to pharmaceutical drugs. In particular, I am asking that you provide information regarding the empirical basis for the often repeated claim that drug companies spend $.5 billion or so to develop new drugs -- an assertion that is considered an important basis for trade policy. In particular, what is the basis for this claim with respect to HIV/AIDS drugs? In considering this request, please consider some additional information. 1. From 1983 to 1993, HIV/AIDS was considered an Orphan disease. During this period, US human use HIV/AIDS clinical trials were eligible for a 50 percent tax credit. This tax credit is evidence of industry spending on clinical trials over this period, for a group of drugs that included HIV/AIDS drugs. The US Department of Treasury can provide your office with data on 50 percent of the industry outlays on Orphan trials as a group. Public statements about the private sector costs of developing HIV/AIDS drugs should be reconciled with this empirical evidence, one would think. We believe the pharmaceutical industry recieved $107 million in orphan drug tax credits over the 1983 to 1993 period. This credit was for the entire group of all orphan drugs, including but not limited to HIV/AIDS drugs. Note also that the orphan drug tax credit is earned for both successful and unsuccesful products, and thus is evidence of outlays for all clincial trials, including those for drugs that did not receive FDA approval. You may want to ask the Department of Treasury to independently confirm this. Once DHHS is aware of 50 percent of the private sector expenditures on human use clinical trials, it should not be difficult to determine what pre-tax and after tax outlays were, per approved drug. Our own analysis is that 93 orphan drugs were approved from 1983 to 1993, suggesting after tax credit private sector outlays of $1.15 million per approved drug, based upon the tax return data. We recognize that this number is quite small, relative to current assumptions regarding costs, and we further assume that there will be various theories as to why this tax credit data is so different than popular belief. But it is, of course, real evidence that should be explained in some way. 2. Our recent analysis of all 14 FDA approved HIV drugs indicates that (a) the average time between filing for a patent and FDA marketing approval was only 4.4 years. This is far longer than the assumed delay between invention and marketing approval assumed in the 1991 Tufts study or the 1993 OTA study (the 1993 OTA study re-calculated the 1991 Tufts study data using higher discount rates). 3. Our own review of applications for FDA new drug approvals (NDAs) for HIV drugs has found that these applications typically do not involve large numbers of patients in clinical trials, and often key clinical trials are sponsored by federal agencies. Those who are looking at these issues might want to look at the following web page, which contains factual information on the invention and IPR status of HIV/AIDS drug: http://www.cptech.org/ip/health/aids/druginformation.html Thank you. James Love Director Consumer Project on Technology http://www.cptech.org love@cptech.org 202.387.8030 -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Thu Jan 6 15:21:08 2000 Return-Path: Delivered-To: pharm-policy@lists.essential.org Received: from cptech.org (jamie.essential.org [216.0.124.36]) by venice.essential.org (Postfix) with ESMTP id CA2D521B0B; Thu, 6 Jan 2000 15:21:08 -0500 (EST) Sender: jamie@venice.essential.org Message-ID: <3874F8D5.E1ED94DA@cptech.org> Date: Thu, 06 Jan 2000 15:19:33 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Rep. Berry's web page on pharmacuetical drugs Representative Marion Berry, the only pharmacist in the US Congress, has a terrific web page with links to various studies on pharmaceutical drugs: http://www.house.gov/berry/prescriptiondrugs/studies.htm One of the studies is the December 13, 1999 Congressional Research Service report: Federal Taxation of the Drug Industry from 1990 to 1996, by Gary Guenther. James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Thu Jan 6 18:01:12 2000 Return-Path: Delivered-To: pharm-policy@lists.essential.org Received: from cptech.org (jamie.essential.org [216.0.124.36]) by venice.essential.org (Postfix) with ESMTP id 0492D21B0B; Thu, 6 Jan 2000 18:01:11 -0500 (EST) Sender: jamie@venice.essential.org Message-ID: <38751E5A.77CCBDFD@cptech.org> Date: Thu, 06 Jan 2000 17:59:38 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Other Congressional web sites on pharmaceutical drugs I should have mentioned by that CRS report on taxation of the pharmaceutical industry was requested by Rep. Pete Stark. Here are some additional web sites on pharmaceutical drugs maintained by members of Congress. Rep. Bernie Sanders: http://www.house.gov/bernie/legislation/pharmbill/index.html Rep. Pete Stark http://www.house.gov/stark/perdrug.html Rep. Henry Waxman http://www.house.gov/waxman/pharm/ Rep. Marion Berry http://www.house.gov/berry/prescriptiondrugs/ Rep. Tom Allen http://www.house.gov/allen/drugbill.htm -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Thu Jan 6 19:17:10 2000 Return-Path: Delivered-To: pharm-policy@lists.essential.org Received: from cptech.org (jamie.essential.org [216.0.124.36]) by venice.essential.org (Postfix) with ESMTP id 095DB21B75; Thu, 6 Jan 2000 19:17:10 -0500 (EST) Sender: jamie@venice.essential.org Message-ID: <38753028.C53A6E6@cptech.org> Date: Thu, 06 Jan 2000 19:15:36 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy , healthgap Subject: Re: [Pharm-policy] letter to Dr. Novotny regarding empirical basis for trade policy References: <3874EBFB.9F1AF17B@cptech.org> <38752C28.2D1A540B@utoronto.ca> Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit A few persons have written to point out a careless error in the letter to Dr. Novotny. In the discussion of the time between filing for a patent and FDA marketing approval, I should have stated that the 4.4 years for HIV/AIDS drugs was far "shorter" than the time assumed in the Tufts study, rather than longer. Jamie -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Fri Jan 7 10:19:43 2000 Return-Path: Delivered-To: pharm-policy@lists.essential.org Received: from cptech.org (jamie.essential.org [216.0.124.36]) by venice.essential.org (Postfix) with ESMTP id ADD3921B75; Fri, 7 Jan 2000 10:19:43 -0500 (EST) Sender: jamie@venice.essential.org Message-ID: <387603B9.38A5818A@cptech.org> Date: Fri, 07 Jan 2000 10:18:17 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] The R&D Tax Credit and Industry Spending on R&D These are some data from Pete Stark's December 13, 1999 CRS report on taxation of the pharmaceutical industry. What is interesting to me is the relatively small numbers for the R&D tax credit, which was around $200 million per year for the entire pharmaceutical industry. Like the Orphan Drug Tax Credit, this is evidence of levels of industry spending on R&D. However, the relationship between the R&D tax credit and expenditures is more complex than is the case for the Orphan Drug Tax Credit, and it is somewhat more difficult to estimate levels of qualifing R&D investments. In general, it is 20 percent of the increase in R&D spending over a "base amount," for some R&D expenditures (the base amount is the product of the percentage of revenues spent on R&D from 1983 to 1989, multiplied by the average revenue over the past four years, but not less than 50 percent of qualified expenditures), and 20 percent of the total of other expenditures. But we'll try to make a model of the credit and publish some results. For example, and this is really quick and dirty, if one assumed that the base amount was always 50 percent of qualifying expenditures, the credit would be equal to 10 percent of qualifying expenditures (.2 X .5 = .1). Thus, for example, the $219 million in 1996 tax credits would imply total industry spending on R&D was $219/.1 = $2.19 billion. To put this into perspective, PhRMA claims that industry domestic R&D spending was actually $13.6 billion in 1996, or more than six times the amount predicted by this simple model of the R&D tax credit. Clearly it will be difficult to reconcile the PhRMA assertions with the IRS data, even after working on the model. Note: It would be very helpful if the IRS could publish not only the amount of the credit, but the amount of the qualifying R&D expenditures, upon which the credit was based. To understand how complex the general R&D tax credit is, check out the statute here: http://www4.law.cornell.edu/uscode/26/41.html Here are the data and the URL for the Stark report. Jamie http://www.house.gov/berry/prescriptiondrugs/Resources/crs_pharm_tax_memo.PDF Orphan Drug Tax Credit 1990: 15 1991: 18 1992: 17 1993: 19 1994: 19 1995: NA 1996: NA Other Tax Credits You may be interested in Foreign Tax Credit: 1990: 1,205 1991: 1,367 1992: 1,613 1993: 1,960 1994: 1,960 1995: 2,633 1996: 2,628 Possessions Tax Credit (Primarily Puerto Rico I assume) 1990: 1,665 1991: 1,883 1992: 2,033 1993: 2,150 1994: 2,116 1995: 1,611 1996: 1,651 General Business Tax Credit (R&D tax credit) 1990: 142 1991: 150 1992: 180 1993: 208 1994: 271 1995: 214 1996: 219 -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Mon Jan 10 16:04:25 2000 Return-Path: Delivered-To: pharm-policy@lists.essential.org Received: from cptech.org (jamie.essential.org [216.0.124.36]) by venice.essential.org (Postfix) with ESMTP id 8FDF621AFF; Mon, 10 Jan 2000 16:04:25 -0500 (EST) Sender: jamie@venice.essential.org Message-ID: <387A4925.6BB685F1@cptech.org> Date: Mon, 10 Jan 2000 16:03:33 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Today's annoucement by Gore on HIV/AIDS initiative Here is today's announcement by Vice President Gore regarding HIV/AIDS and other infectious diseases. A few comments: a. Nice statements regarding how serious is the public health crisis b. Not much money, given the serious nature of the problem. c. Lots of issues not addressed in the press release. Jamie January 10, 2000 VICE PRESIDENT AL GORE UNVEILS NEW $150 MILLION INITIATIVE TO COMBAT THE SPREAD OF AIDS AND CONTRIBUTE TO INTERNATIONAL INFECTIOUS DISEASE PREVENTION EFFORTS THE WHITE HOUSE Office of the Vice President _______________________________________________________________ For Immediate Release Contact: Monday, January 10, 2000 (202) 456-7035 VICE PRESIDENT AL GORE UNVEILS NEW $150 MILLION INITIATIVE TO COMBAT THE SPREAD OF AIDS AND CONTRIBUTE TO INTERNATIONAL INFECTIOUS DISEASE PREVENTION EFFORTS New York, NY -- Today, in a speech before the United Nations, Vice President Al Gore will announce that the Administration's FY 2001 budget include a new $150 million investment to assist efforts to combat the international AIDS pandemic and contribute to international infectious disease prevention efforts. This new initiative provides $100 million for preventing and treating HIV and AIDS in Africa, Asia, and other regions of the world -- double last year's increase. It also dedicates $50 million for purchasing vaccines against other diseases that ravage poor nations, including hepatitis B, certain forms of meningitis and yellow fever, helping to save millions of children. Purchasing existing vaccines is the first step toward accelerating the development and delivery of vaccines for AIDS, malaria, TB, and other diseases disproportionately affecting the developing world. This investment is part of a comprehensive plan for action that will meet the Administration's commitment in this area, as described in the President's September speech to the U.N. General Assembly. "AIDS and other infectious diseases are the largest catastrophes in the history of modern medicine," Vice President Gore said. "We hope this initiative will provide relief and hope to the millions of children and families around the world." THE AIDS PANDEMIC THREATENS THE ECONOMIC AND SOCIAL STABILITY OF SUB SAHARAN AFRICA AND ASIA. The United Nations calls the AIDS pandemic in sub-Saharan Africa "the worst infectious disease catastrophe since the bubonic plague." An estimated 5.7 million people were infected with HIV by the end of 1999, and India may have become the country with the largest number of new infections this year. ** Sub-Saharan Africa and Asia disproportionately bear the impact of the AIDS epidemic. While sub-Saharan Africa accounts for only one-tenth of the global population, over 70 percent of individuals infected with AIDS globally live there. Currently, 22.5 million people in sub-Saharan Africa are infected with HIV, and every day, an additional 11,000 become infected. In Asia, HIV and AIDS is already widespread. Because this region has 60 percent of the world's population and has the steepest infection curve, experts are predicting that Asia will soon become the epicenter of the epidemic. In addition, during the next decade, more than 40 million children in Africa will be orphaned by AIDS, making it difficult -- if not impossible -- for them to obtain adequate food, clothing, education, and health care services. ** The AIDS epidemic is jeopardizing the economic stability of the sub-Saharan African and Asian regions. The economic toll in HIV and AIDS are taking in Africa underscores the linkage between the spread of this disease and poverty in the region. Although Africa is making unprecedented economic gains, they are jeopardized by an infection which is killing skilled personnel -- and which demands increased investment in government spending. ** The AIDS pandemic threatens Africa and Asia's regional and national security. High levels of HIV infection among members of the armed forces weakens their ability to perform their national duties. In addition, studies have linked the growing number of children orphaned by AIDS to future increases in crime and civil unrest as these children raise themselves alone, often turning to crime, drugs, prostitution, and gangs to survive. ONE THIRD OF ALL DEATHS EACH YEAR WORLDWIDE -- 17 MILLION PEOPLE -- RESULT FROM INFECTIOUS DISEASES. The developing world bears a disproportionate burden of these diseases, which not only destroy lives, but perpetuate the cycle of sickness and poverty. Vaccines have been critical and cost-effective weapons that have eradicated smallpox, reduced polio to the lowest levels in history, and drastically lowered measles rates. Building upon these extraordinary achievements, we must work to ensure that all children have access to effective vaccines. ** Over eight million children die each year of centuries-old diseases and more than four million of these deaths could be prevented by existing vaccines. The dramatic expansion of vaccine coverage in the past several decades now saves almost three million lives each year, and prevents hundreds of thousands of cases of paralysis and blindness. Yet, the wider use of existing vaccines against hepatitis B, certain forms of meningitis, yellow fever, and other diseases could prevent an additional four million deaths each year and reduce untold suffering. ** Immunization is one of the most cost-effective health interventions. It costs only $15 to immunize a child, yet in developing countries, children remain 10 times more likely to die of a vaccine-preventable disease than those in the industrialized world. ** Vaccines are one of the most cost-effective ways to improve the well-being and productivity of the poorest countries. Investments in health are as central to economic progress in poor countries as investments in education and physical infrastructure. Yet, because these countries often cannot afford to buy vaccines, the market does not provide incentives for pharmaceutical companies to develop vaccines for diseases that disproportionately affect developing nations. ** Effective vaccines do not yet exist for malaria, TB and AIDS, which kill nearly 6 million people each year. Because developing countries often cannot afford to buy vaccines, the market does not provide incentives for pharmaceutical companies to develop vaccines for diseases that disproportionately affect those countries. Only 2 percent of all global biomedical research by the public and private sectors is devoted to the major killers in the developing world. Vaccines are the best solution for these diseases, but progress has stalled. The global community must intensify both research and development, and make commitments to purchase new vaccines for these diseases when developed. VICE PRESIDENT GORE UNVEILS NEW, $150 MILLION INITIATIVE TO COMBAT AIDS AND OTHER INFECTIOUS DISEASES. Today, in a speech before the United Nations, Vice President Gore will announce that the President's FY 2001 budget will include a new, multi-million dollar investment in combating the spread of HIV, AIDS, and other infectious diseases in Africa, Asia and other developing countries. This initiative will: ** Invest an additional $100 million in HIV and AIDS prevention and treatment efforts in Africa and Asia. The President's budget will invest a total of $325 million in HIV prevention and AIDS treatment around the world, doubling last year's allocation. Funds will be targeted to the countries where the disease is most widespread and where our efforts will have the greatest impact. Activities include: Increasing primary prevention efforts. To reduce the incidence of new HIV infections, this initiative will help to: implement mass education efforts and community based counseling and testing services, provide AZT short-course therapy to infected individuals to prevent further transmission, implement treatment protocols to reduce mother to child transmissions, and implement blood supply screening procedures. Providing care and treatment for individuals infected with HIV. Currently, treatment options for HIV infected people in sub-Saharan Africa and India are limited; less than 5 percent of people know their HIV status, and health care providers are often without the tools necessary to diagnose and treat HIV and the associated opportunistic infections. This initiative will provide medical and social services to individuals with HIV, including treatment of sexually transmitted diseases, opportunistic infections associated with HIV, and tuberculosis. Caring for children orphaned by AIDS. Together with host government and social service agencies, this initiative will invest $10 million to provide school fees, food assistance, counseling, basic health care, and other services that orphaned children need through community mobilization programs. Strengthening the public health infrastructure. This initiative will assist African and Asian institutions in effectively tracking the spread of HIV infections throughout the Sub-Saharan and Asian regions, in order to focus HIV and AIDS prevention and treatment resources and provide training and technical assistance to developing clinics and community based organizations delivering prevention and care. Assisting armed forces in preventing the spread of HIV within military organizations. The DoD will work with its African counterparts to invest $10 million to prevent the spread of HIV within military agencies throughout Africa. Initiating HIV prevention programs in the workplace. This initiative will invest $10 million to initiate workplace programs designed to reduce discrimination against employees infected with HIV and AIDS . Funds will also be used to develop partnerships with the business and labor communities to launch HIV prevention activities for employees, their families and communities. ** Invest $50 million in purchasing vaccines for developing countries. As part of a broad Administration vaccine initiative, the budget includes a new $50 million investment in the Global Fund for Children's Vaccines. The fund, administered by the Global Alliance for Vaccines and Immunizations (GAVI), a new, collaborative effort of UNICEF, the World Bank, the World Health Organization, and other governments and private organizations around the world. Initial contributions to this fund will be used to purchase existing vaccines for hepatitis B, haemophilus influenzae B, and yellow fever, along with related safe injection equipment. Vaccine purchases will be administered through UNICEF, which runs an efficient immunization program today. This fund is one step toward encouraging the development and delivery of new vaccines. The developed nations have the scientific and technological capacity to make new vaccines possible, and a renewed international commitment to purchase vaccines will encourage private research and development. The Administration is now developing further proposals to accelerate the invention and production of new vaccines, and to increase investment by developing nations in building sound delivery systems for vaccines, medicines, and other basic health services. From owner-pharm-policy@venice.essential.org Mon Jan 10 17:22:56 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id B5F8421AFF; Mon, 10 Jan 2000 17:22:55 -0500 (EST) Received: from cptech.org (fluid.essential.org [216.0.124.57]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id RAA20868; Mon, 10 Jan 2000 17:22:55 -0500 Sender: tb@genoa.essential.org Message-ID: <387A5C1C.BCEE3D28@cptech.org> Date: Mon, 10 Jan 2000 17:24:28 -0500 From: Thiru Balasubramaniam Organization: Consumer Project on Technology X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: Multiple recipients of list IP-HEALTH , Multiple recipients of list PHARM-POLICY Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Full Text of Al Gore's speech before the UN Security Council on AIDS in Afica The following is the full text of Vice-President Al Gore's speech before the UN Security Council Session on Aids in Africa on January 10, 2000. A brief excerpt precedes the full text: " We are also committed to helping poor countries gain access to affordable medicines, including those for HIV/AIDS. Last month, the President announced a new approach to ensure that we take public health crises into account when applying U.S. trade policy. We will cooperate with our trading partners to assure that U.S. trade policies do not hinder their efforts to respond to health crises." U.N. SECURITY COUNCIL SESSION ON AIDS IN AFRICA THE WHITE HOUSE Office of the Vice President For Immediate Release Contact: Monday, January 10, 2000 (202) 456-7035 REMARKS AS PREPARED FOR DELIVERY BY VICE PRESIDENT AL GORE U.N. SECURITY COUNCIL SESSION ON AIDS IN AFRICA Mr. Secretary General, Members of the Security Council, Distinguished Guests, and, in particular, Honored Delegates from the Nations of Africa: "HIV/AIDS is not someone else's problem. It is my problem. It is your problem. By allowing it to spread, we face the danger that our youth will not reach adulthood. Their education will be wasted. The economy will shrink. There will be a large number of sick people whom the health will not be able to maintain." Mr. Secretary and Members of the Council: These are not my words. They were not uttered in the United States or the United Nations. They were spoken by my friend, President Thabo Mbeki of South Africa, as he declared South Africa's Partnership Against AIDS more than a year ago. The same words should be spoken out not only in South Africa, not only in Africa, but all across the earth. In Africa, the scale of the crisis may be greater, the infrastructure weaker, and the people poorer, but the threat is real for every people and every nation, everywhere on earth. No border can keep AIDS out; it cuts across all the lines that divide us. We owe ourselves and each other the utmost commitment to act against AIDS on a global scale -- and especially where the scourge is greatest. AIDS is a global aggressor that must be defeated. As we enter the new millennium, Africa has crossed the first frontiers of momentous progress. Over the past decade, a rising wave of African nations has moved from dictatorship to democracy, embraced economic reform, opened markets, privatized enterprises, and stabilized currencies. More than half the nations of Africa now elect their own leaders -- nearly four times the number ten years ago -- and economic growth in sub-Saharan Africa has tripled, creating prospects for a higher quality of life across the continent. Tragically, this progress is imperiled, just as it is taking hold, by the spread of AIDS which now grips 20 million Africans. Fourteen million have already died -- one quarter of them children. Each day in Africa, 11,000 more men, women, and children become HIV positive -- more than half of them under the age of 25. For the nations of sub-Saharan Africa, AIDS is not just a humanitarian crisis. It is a security crisis -- because it threatens not just individual citizens, but the very institutions that define and defend the character of a society. This disease weakens workforces and saps economic strength. AIDS strikes at teachers, and denies education to their students. It strikes at the military, and subverts the forces of order and peacekeeping. The United States is profoundly moved by the toll AIDS takes in Africa. At the same time, we know that our own country has not achieved as much as we should or must in our own battle against AIDS. I am pleased that our Surgeon General is here today; his recent report tells us that we have not overcome the ignorance and indifference that lead to infection. We must continue to study the success of others, while we seek to share our progress with them. As Vice President, I have journeyed four times to sub-Saharan Africa. I have taken along top health officials, AIDS specialists, corporate leaders, and physicians. We have spent long hours with African leaders, heard their ideas, and discussed their difficulties with the fateful crisis of AIDS. It is inspiring to see so many in Africa -- not only leaders, but health care workers and community workers, mothers and fathers, and countless ordinary citizens -- fighting to save the lives of the people they love. Ten years ago, Uganda was suffering the world's highest infection rates. Today -- because the whole nation has mobilized to end stigma, urge prevention, and change behavior -- Uganda is now recording dramatic drops in the infection rate. Uganda, which used to be proof of the problem, is now powerful proof that we can turn the tide against AIDS. We know that the first line of defense against this disease is prevention. And prevention depends on breaking down the barriers against discussing the extent and risks of AIDS. That is one purpose of this historic Security Council meeting. Today, in sight of all the world, we are putting the AIDS crisis at the top of the world's security agenda. We must talk about AIDS not in whispers, in private meetings, in tones of secrecy and shame. We must face the threat as we are facing it right here, in one of the great forums of the earth -- openly and boldly, with urgency and compassion. Until we end the stigma of AIDS, we will never end the disease of AIDS. We also must do much more to provide basic care and treatment to the growing number of people who, thank God, are living, instead of dying, with HIV and AIDS. This requires affordable medicine, but also more than medicine; it requires that we train doctors, nurses, and home-care workers, that we develop clinics and community-based organizations to deliver care to those who need it. Today, fewer than 5 percent of those living with AIDS in Africa have access to even basic care. We know we can prolong life, reduce suffering, and allow mothers with AIDS to live longer with their children, if we offer treatment for opportunistic infections like tuberculosis and malaria. Our ultimate goal, our best hope, is to prevent AIDS by vaccination, and we are committed to the maximum possible research. But we need to do more to harness the talent and power of the private sector. In September, in his speech to the General Assembly, President Clinton said it was wrong that only two percent of all biomedical research is directed to the major killer diseases in the developing world. He pledged America to a new effort to speed the development and delivery of vaccines for AIDS, malaria, TB, and other illnesses that disproportionately afflict the poorest nations. This three-part strategy of prevention, treatment, and research is the right fight. And the United States has contributed more than a billion dollars to wage it worldwide -- more than half of that for sub-Saharan Africa. But we must do more. Last year, I announced the largest-ever increase in the U.S. commitment to international AIDS programs -- $100 million to fight AIDS in Africa, India, and other areas. Today, I announce America's decision to step up the battle. The budget the Clinton-Gore Administration will send to our Congress next month will include an additional increase of $100 million for a total of $325 million to fund our worldwide fight against AIDS. This new funding will include efforts: --To reduce the stigma and prevent the spread of AIDS; --To reduce mother-to-child transmission; --To support home and community based care for people with AIDS; --To provide care for children orphaned by AIDS; --And to strengthen health infrastructure to prevent and treat of AIDS. I would also like to announce here this morning that the budget we will send to our Congress next month will include $50 million for the United States' contribution to the Vaccine Fund of the Global Alliance for Vaccines and Immunizations. This contribution -- in fulfillment of the promise President Clinton made to the General Assembly -- will help fund the research, purchase, and distribution of lifesaving vaccines in developing nations. I am also announcing today an initiative for an expanded public-private partnership in the battle against AIDS. Indeed, in the coming months, I will convene a meeting of U.S. business leaders active in Africa, to develop a set of voluntary principles for corporate conduct to make the workplace an effective place for the education and prevention of AIDS. Let us also set this goal: through public and private efforts, in partnership with partner nations, we will attack the cycle of infection at one critical point -- its most heartbreaking point -- the moment of mother-to-child transmission. In addition, I announce that our budget request for next year will --for the first time ever -- offer specific funding for the U.S. military to work with the armed forces of other nations to combat AIDS. Inside our own country, our armed forces have acted effectively to prevent the spread of AIDS in the military. Secretary of Defense Cohen is ready to share our experience with our military counterparts in Africa. We are also committed to helping poor countries gain access to affordable medicines, including those for HIV/AIDS. Last month, the President announced a new approach to ensure that we take public health crises into account when applying U.S. trade policy. We will cooperate with our trading partners to assure that U.S. trade policies do not hinder their efforts to respond to health crises. But to win the ongoing global battle against AIDS, we must also fight the poverty that speeds its spread. In June, in Cologne, we joined with our G-7 partners in the Cologne Debt Initiative, a landmark commitment to faster and deeper debt relief for the heavily-indebted poor countries. We will continue to engage our G-7 partners to bring greater resources to this effort. Today I challenge the world's wealthier, healthier nations to match America's increasing commitment to a worldwide crusade against AIDS. But more money is not enough. We must also make sure that more money has more impact. Next July, the global community will gather in Durban, South Africa for the 13th International AIDS Conference. There are many inspiring efforts to fight AIDS all around the world. Right now, they amount to many isolated efforts, not a single focused assault. We must knit together the separate initiatives by local, national, regional, and global organizations, to take maximum advantage of their synergy and success. We will work with the organizers of the Durban Conference to advance this essential objective. It is essential, because how we speed the money, and how effectively we target it, not just how much we spend, will determine how many lives we save. AIDS is one of the most devastating threats ever to confront the world community. Many have called the battle against it a sacred crusade. The United Nations was created to stop wars. Now, we must wage an win a great and peaceful war of our time -- the war against AIDS. For all, here and around the world, willing to enlist in this cause, let us hear and heed and take heart from the words of an African poet, Mongane Wally Serote: "remember the passion of our hearts the blinding ache and pain when we heard the hysterical sobs of our little children crying against fate .... we heard these, we knew them, we absorbed them but we surged forward knowing that life is a promise, and that that promise is us..." That promise is us. We here in this room -- representing the billions of people of the world -- we must become the promise of hope and of change. We must become the promise of life itself. We have the knowledge, the compassion, and the means to make a difference. We must acknowledge our moral duty and accept our great and grave responsibility to succeed. We must make the promise and keep the promise to prevail against this disease -- so that when the story of AIDS is told to future generations, it will be a tale not just of human tragedy but of human triumph. And the moral of that story will be the capacity of the human spirit to summon us in common cause, to defeat a common foe, and secure the health and hopes of so many of our fellow human beings. May God bless all who have suffered from this disease. May God bless the united effort of our united nations to end it -- soon and forever. From owner-pharm-policy@venice.essential.org Mon Jan 10 18:28:50 2000 Return-Path: Delivered-To: pharm-policy@lists.essential.org Received: from cptech.org (jamie.essential.org [216.0.124.36]) by venice.essential.org (Postfix) with ESMTP id C53F221C20; Mon, 10 Jan 2000 18:28:50 -0500 (EST) Sender: jamie@venice.essential.org Message-ID: <387A6AFF.6A2E7DEC@cptech.org> Date: Mon, 10 Jan 2000 18:27:59 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Nafta and parallel imports I had a call from someone who wants to sue under NAFTA, for the right to provide parallel imports of pharmaceutical drugs (a potentially profitable business, given the huge differences in prices between the USA and Canada.) He wanted to know if he had a legal basis for doing this, under Nafta. So one else wanted to know if Nafta restricted parallel imports in any way. Do any of the Nafta experts know much about this? Jamie -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Mon Jan 10 18:31:13 2000 Return-Path: Delivered-To: pharm-policy@lists.essential.org Received: from cptech.org (jamie.essential.org [216.0.124.36]) by venice.essential.org (Postfix) with ESMTP id 1C23821B57; Mon, 10 Jan 2000 18:31:13 -0500 (EST) Sender: jamie@venice.essential.org Message-ID: <387A6B8E.7CB1C5FD@cptech.org> Date: Mon, 10 Jan 2000 18:30:22 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Rep. Jessie Jackson, Jr. on Gore speech on HIV/AIDS FOR IMMEDIATE RELEASE FRANK E. WATKINS MONDAY, JANUARY 10, 2000 202-225-0773 ON GORE'S INCREASED AID FOR AFRICAN AIDS: LITTLE AND LATE Rep. Jesse Jackson, Jr. said today that "Vice President Al Gore should be commended for highlighting the problem of HIV/AIDS in Africa before the United Nations, but the help he offered of an additional $100 million from the U.S as a first step -- $4.35 per person for each of the 23 million Africans who are infected with HIV/AIDS -- is little and late. Why little and late? Unless something dramatic is done, it is projected that more Africans will die in the first decade of the 21st century than have died in all the wars of the 20th century. Every minute we delay, ten more people are infected with the HIV/AIDS virus. By 2010, HIV/AIDS is expected to create 40 million orphans. Africans speak more than 1500 languages. The $100 million is not to fight HIV/AIDS directly, but to educate 650 million Africans about HIV/AIDS -- which amounts to $.15 per African. It is in the security insterests of the U.S. and the world to address this issue." Jackson also said, "When the Clinton-Gore administration had the option of supporting a bill that would have addressed the HIV/AIDS crisis and the many other important issues that are negatively impacting Africa (e.g., debt relief) it chose instead to support the African Growth and Opportunity Act (AGOA) -- which was finally amended to include a sense of the Congress' good intentions relative to HIV/AIDS, but actually did nothing about HIV/AIDS. AGOA will only perpetuate many of the serious problems confronting Africa. "Not only did the Clinton-Gore administration support AGOA, it also rejected and strongly fought against an alternative bill that I offered called the HOPE (Human Rights, Opportunity, Partnership and Empowerment) for Africa Act (H.R. 772) which would have meaningfully addressed HIV/AIDS, debt relief and many other problems facing Africa. "The Gore campaign has been plagued from the start with protests against the Clinton-Gore administration's AIDS policy towards Africa. As the Chicago Tribune reported yesterday, 'When AIDS-plagued South Africa hinted that it might manufacture its own AZT, an expensive anti-retroviral drug, the U.S. government, backed by the pharmaceutical industry, threatened sanctions. Patent laws were at stake. And despite President Clinton's recent promise to intervene on South Africa's behalf, the confrontation remains at an impasse.' "If the Clinton-Gore administration is actually serious about dealing with the African HIV/AIDS crisis, it can still support H.R. 2700, the 'Highly Essential Life-Saving Pharmaceuticals (HELP) for Africa Act' which is currently before Congress. It resolves the 'compulsory licensing' and 'parallel importing' issues that serve even today as barriers to confronting this issue and would go a long way toward giving aid and relief to the suffering people of Africa. Our money and commitment must match the size of the problem," Jackson concluded. -30- **************************** Frank E. Watkins Press Secretary/Director of Communications Office of Congressman Jesse L. Jackson, Jr. 313 CHOB Washington, DC 20515-1302 Voice: 202-225-0773 Fax: 202-225-0899 Home Voice: 202-554-5580 frank.watkins@mail.house.gov From owner-pharm-policy@venice.essential.org Tue Jan 11 13:04:47 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 0DBB221CAB; Tue, 11 Jan 2000 13:04:47 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id NAA02362; Tue, 11 Jan 2000 13:04:46 -0500 Sender: jamie@genoa.essential.org Message-ID: <387B7094.ACD3D3C8@cptech.org> Date: Tue, 11 Jan 2000 13:04:04 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] PhRMA's Dec 3, 1999 NTE submission Pharma has posted on its web page its December 3, 1999 submisssion of PhRMA for the US National Trade Estimate Report on Foreign Trade Barriers, for the year 2000 US report. It is here: http://www.phrma.org/issues/intl/nte.html -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Tue Jan 11 13:12:30 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 4B20421B97; Tue, 11 Jan 2000 13:12:30 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id NAA02540; Tue, 11 Jan 2000 13:12:30 -0500 Sender: jamie@genoa.essential.org Message-ID: <387B7263.E4F792CD@cptech.org> Date: Tue, 11 Jan 2000 13:11:47 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] PhRMA's Dec 3, 1999 NTE submission: Dominican Republic PhRMA's Dec 3, 1999 NTE submission: Dominican Republic http://www.phyma.org/issues/intl/dominican.html Dominican Republic Intellectual Property Protection On September 1999 an industrial property bill was introduced to Congress. The purpose of the bill is to bring the Dominican Republic into conformity with the minimum standards of protection established under the TRIPS agreement. The bill has already been approved by the Senate and is now before the Chamber of Deputies. Approval of the same is regarded as imminent. Unfortunately, the bill in its present form, includes a number of elements of questionable consistency with TRIPS compliant, namely: 1.Compulsory licensing: The industrial property bill contemplates the grant of automatic licenses on the sole basis of the denial of a contractual license. 180-days after the contractual license is requested, the administrative authorities must grant a compulsory license to the third party requesting the same, without having to prove any fault by the patent holder or without requiring the third party to have any technical capabilities for the exploitation the patent. This automatic license is in addition to compulsory licenses, which would be granted in cases of lack of exploitation, abuse due to non-competitive practices, public interest and cases of dependent patents. 2.Article 39 of TRIPS contemplates the protection of undisclosed tests or other data filed before sanitary authorities as a precondition of approving the marketing of a pharmaceutical, agricultural or chemical product. This provision is not only absent in the bill, but to the contrary, the bill includes an authorization of all uses of a patent which are necessary to obtain health registration or approval for commercialization of a product. 3.The bill discriminates between foreigners and nationals by requiring foreigners to place a bond in an amount sufficient to cover court costs and legal fees in cases where they appear as plaintiffs in a lawsuit. This goes against the National Treatment stipulated by Article 3 of TRIPS. The intellectual property bill (copyright) also before Congress, expressly states that the aforementioned bond will not be required. 4.The bill excludes patenting of second uses, does not include protection for vegetable obtentions, business or economic plans or non-biological methods and processes connected with living materials. Additionally, the Department of Health continues its practice to issue health registrations (equivalent to a permission to commercialize) to products that violate locally registered patents in spite of legal requests to the contrary. -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Tue Jan 11 13:20:23 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id AAAD921B02; Tue, 11 Jan 2000 13:20:23 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id NAA02750; Tue, 11 Jan 2000 13:20:22 -0500 Sender: jamie@genoa.essential.org Message-ID: <387B743C.19191141@cptech.org> Date: Tue, 11 Jan 2000 13:19:40 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Cc: "Bun, Mara" Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] PhRMA NTE submissions is for Australia One of the longest PhRMA NTE submissions is for Australia. Here is the part of the PhRMA submission that concerns the Australia cost containment policies, which PhRMA claims are a barrier to US trade: Jamie http://www.phrma.org/issues/intl/australia.html [snip] Pricing and Cost Containment Policies' Impact on IPR and Market Access The Australian Government operates effectively as a monopsony purchaser of prescription pharmaceuticals through its operation of the Pharmaceutical Benefits Scheme (PBS). The PBS system accounts for approximately 80% of total prescription drug sales. The PBS aims to provide reliable and affordable access to medicines for the Australian community. Under the PBS, the cost of pharmaceuticals to consumers is limited by capped co-payments and safety net provisions, with the Government paying the remainder. The Industry Commission Inquiry into the Pharmaceutical Industry (May 1996) found that "the Government's use of market power saves taxpayers up to $A860 million a year." In effect, the industry thus subsidizes taxpayers to this extent. In recognition of this price suppression, in April 1997, the Australian Government announced the Pharmaceutical Industry Investment Program (PIIP), under which the Government will allocate A$300 million over the next 5 years to eligible companies in return for activity. One month later, in May 1997, the Australian Government announced its intention to introduce Therapeutic Group Premiums (reference pricing) from February 1, 1998, for certain classes of drugs which have "similar clinical activity." For each of these classes, a base or benchmark price was established. The Government reimburses drugs in the class to the level of the base/benchmark price product. For other drugs in the class, patients have to pay any additional premium. Originally, six classes of drugs were proposed for the TGP; however, strong opposition by industry and medical groups to the inclusion of beta blockers and SSRIs resulted in their exemption from the TGP. The four remaining classes affected by the TGP include: ACE inhibitors and calcium channel blockers used to treat high blood pressure and heart disease; the HMG class of drugs for treating high cholesterol; and H2 receptor antagonists for the treatment of ulcers. The Government hopes to achieve PBS savings of A$460 million over 4 years, through the introduction of TGPs. The TGP proposal is expected to return to Government revenue almost double the average A$60 million per year foreshadowed in the PIIP. The TGP proposal should be considered in the context of Australia's mandatory cost effectiveness criteria, under which manufacturers must already justify the price of their drug through economic and therapeutic evidence, in order to gain reimbursement. The research-based pharmaceutical industry maintains the position that there are several reasons why TGPs are not appropriate in the Australian reimbursement system. More specifically, TGPs: contradict the principle of evidence-based medicine; do not recognize that some products are not interchangeable, and that individuals do not necessarily respond in an average or predictable way; shift costs to other arms of the healthcare system; tend to create a two-tier system of drug access; send a negative message to industry because prices in the Australian market are already low; discourage R&D and marketing of the latest products; result in loss of investment and employment. undermine the principles of patent protection Impact on intellectual property The TGP system effectively negates the economic value of the entire remaining patent life of a patented medicine in the affected classes. This occurs through a combination of the way in which the proposal operates and the culture of the Australian health care system. The system involves the grouping of newer patent-protected products with generic versions of older molecules within a therapeutic class (e.g. generic captopril is grouped with patented enalapril; generic cimetidine is grouped with patented famotidine). The benchmark product/price for each class is likely to be set by a generic product - in effect, this generic product becomes the 'de facto' generic for all other patented products in the class, regardless of patent life. The Government will reduce the level of reimbursement it currently provides to all products in the class to that of the benchmark product. The Government claims that the TGP system allows manufacturers to charge whatever price they wish - a claim which is theoretically correct. However, the PBS, which has operated for over 50 years, has created a climate in which free medicine (apart from the co-payment to Government) is seen as the norm. Market experience has shown that consumers are unwilling to pay more than a A$2 premium for any medicine (in addition to any co-payment). Given this environment, manufacturers have the choice of maintaining their current prices and losing substantial volume, or reducing their price and revenue. In either case, the economic return is substantially less than would otherwise have occurred in the absence of TGPs. The reduced return is sustained throughout the remaining life of any patent, devaluing the value of the intellectual property. Impact on market access In the Australian context, market access effectively equates to reimbursement. This is because the PBS system accounts for approximately 80% of total prescription drug sales. The 1996 Industry Commission inquiry found evidence that community access to some drugs was adversely affected by the PBS; and that while Australia has not suffered too much in this area, the position is unlikely to be sustainable because when low prices are taken into account, the overall impact of the PBS has been to reduce sales revenues of some companies, increasing the risk of non-supply. The introduction to TGPs inevitably will lead to increased risk of non-supply. As Paul Gross, a consultant to the research-based industry, concludes in his report, "There is serious concern amongst pharmaceutical manufacturers that a second stage of TGP pricing in Australia might attempt to use the price relativities established in prior economic appraisals of different drugs (cost effectiveness analysis) to readjust the first year relative prices between reference priced and non reference priced drugs. Such an adjustment would debase both future and past economic appraisals of drugs on the PBS and places manufacturers in double jeopardy when an arbitrary price control scheme (i.e., TGP) is superimposed on the more objective world recognized economic appraisal guidelines." A concise example of Gross' conclusion is where a new proton pump inhibitor would have to prove cost effectiveness against generic cimetidine. Given the low price of cimetidine, it will be hard to justify cost effectiveness to a level sufficient to make it economically worthwhile for a manufacturer to gain reimbursement of the PPI. The likely outcome is that the PPI will not be reimbursed because the subsidy offered by the Government is too low, and the product will not be made widely available to the Australian community. Market access is effectively denied. -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Tue Jan 11 13:30:14 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 0BE2A21B02 for ; Tue, 11 Jan 2000 13:30:14 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id NAA02963; Tue, 11 Jan 2000 13:30:12 -0500 Sender: jamie@genoa.essential.org Message-ID: <387B768A.50A64382@cptech.org> Date: Tue, 11 Jan 2000 13:29:30 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: ip-helath@cptech.org, pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] PhRMA claims South Africa government agreed to delay in litigation over Medicines Act In its Dec 3, 1999 NTE submission, PhRMA claims that the South African government has agreed to delay the litigation over the South African Medicines Act. I don't know that this is true, and indeed, the only press release I have seen from the South Africa government (and my own conversations with SA officials), says the contrary. Jamie Dec 3, 1999 PhRMA NTE Submisssion: http://www.phrma.org/issues/intl/safrica.html "In 1998, over 40 pharmaceutical companies operating in South Africa, and the South African Pharmaceutical Manufacturers Association (SA PMA) filed a legal challenge to the Medicines Act before the Constitutional Court in South Africa, a new, post-apartheid institution. Both sides have filed briefs before the Court, but the industry has made clear its preference for a negotiated, mutually acceptable solution to the dispute. In June 1999, South Africa held its second free national elections, as a result of which a new Cabinet was appointed. Via the SA PMA, the industry immediately made overtures to the new Government, for the purpose of reaching a mutually acceptable solution to the dispute over the Medicines Act. As a part of the ongoing dialogue between the industry and the Government, both parties to the litigation have agreed to a delay in the schedule of the legal challenge." -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Tue Jan 11 13:42:53 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id A1DD721B02; Tue, 11 Jan 2000 13:42:53 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id NAA03326; Tue, 11 Jan 2000 13:42:52 -0500 Sender: jamie@genoa.essential.org Message-ID: <387B7982.77A04E76@cptech.org> Date: Tue, 11 Jan 2000 13:42:10 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: healthgap , pharm-policy , IP-Health list Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] PhRMA's Dec 3, 1999 Thailand NTE submissions Here is PhRMA's Dec 3, 1999 Thailand NTE submissions. http://www.phrma.org/issues/intl/thailand.html Thailand Intellectual Property Protection While the Thai patent act changed in 1999 with the abolishment of the Price Review board, there are still many features of the Thai Patent Act which will not be changed in the pending legislation: Patentable subject matter - Section 9(1) still excludes naturally existing biologicals which is not in compliance with the requirements of TRIPS. The Bolar type provision which allows generic use of patentable subject material for testing prior to patent expiry of the originator's product, (Section 36(4)) is still the part of the amended Patent Act. Compulsory licensing if the patented product is not produced in Thailand is still incorporated in Section 46. However, the Royal Thai Government will now recognize importation as working the patent. Dependent compulsory licenses, compensation and appeals are all still inconsistent with TRIPS. In addition, the draft Thai law introduces new inconsistencies: Section 6(4) extends the state of the art period to "an invention of which more than eighteen months prior to the date of (application) an (application) in a foreign country has been filed and not been granted. The internationally accepted period is 12 months. This new provision was added to increase the definition of Novelty under the Patent Act to be in conformity with that of PCT. Section 36(7) of the Patent Act allows importation of patented products if the patentee permits or gives consent to the manufacture or sale of the aforesaid product. The current interpretation of the Thai Department of Intellectual Property of Section 39 of the 1992 law is directly opposite to the agreed intent of the law before the law was enacted. The focus is to prevent pending applications from having product claims inserted - as was intended. This calls into question the sincerity of the RTG in providing Intellectual Property Protection. Draft Trade Secrets Law: Thailand is preparing a new trade secrets law to comply with TRIPS. Unfortunately, Section 11(4) attempts to exclude disclosure of trade secrets by a government agency to protect any "public interest" not having commercial objectives. This is intended to allow the use of registration data for generic regulatory filings. Parallel Imports: The Thai pharmaceutical market suffers a relatively high level of parallel imports from other parts of Asia, yet neither the Thai FDA nor other authorities has moved to rectify this situation, despite the dangers that such imports pose to national health. There is recent evidence the Thai FDA is being slightly more diligent in enforcing restrictions on parallel imports. Restrictive Drug Lists The original list (NLED: National List of Essential Drugs) has been in place for several years and was an adaptation of the WHO 'essential drug list' (designed as a minimal list of drugs that should be available to satisfy basic health care needs in developing countries.) The WHO list maintains some 250 compounds. Thailand expanded its list to about 1,400 compounds, but applied a restrictive pricing scheme to limit reimbursement. Because of the severe price restrictions, companies avoided applying for listing on the National List and sought listing on individual hospital formularies since there were no restrictions on having their products prescribed and reimbursed within the hospital system. The MOPH recently indicated that the NLED will now become a maximum list for government hospitals and that products with "provisional registration" subject to a "Safety Monitoring Protocol" (SMP) (i.e., Thailand's form of pipeline protection) would be excluded from the list. The intention of the 1994 Thai FDA Rules on 'Transitory Provision to Conduct Safety Monitoring and Bioequivalence Study of New Drug', to provide pipeline protection for pharmaceutical products patented elsewhere in the world between 1 January 1986 and 30 September 1991 is clearly stated. The procedure required companies to report adverse reactions for a two year period. If requested by the company this could be rolled over for a further "two plus one" year reporting periods during which time the FDA would not accept a registration file for a generic copy. The rules provided up to five years market exclusivity; the only restriction being that sales were restricted to hospitals and clinics (i.e., no drugstore sales). The treatment of the NLED as a maximum list and the exclusion of the opportunity to have SMP drugs included in the list effectively negates the original intent of the provisions to provide pipeline protection and market exclusivity for new products in Thailand. Innovative products qualifying for the SMP will not be listed or stocked in most hospitals. PhRMA believes that the Thai Government's removal of the opportunity to market new products through government hospitals is tantamount to setting up a market access barrier to the introduction of new products in Thailand. Import Policies Drug and raw material imports are subject to duty which currently ranges from 10% to 30% (In the recent economic stimulation initiative, the duty for certain intermediate hormones was reduced to 1%). The duty rate for drugs where a generic equivalent is not manufactured in Thailand is normally 10%. The duty rate for imported finished goods that compete with locally manufactured product is 20% to 30%. While there are no specific policies which mandate "BUY THAI", the government hospitals are strongly encouraged to buy locally produced products where ever possible. Standards, Testing and Labeling Requirements A new chemical entity can be registered in Thailand, but the filing will not be accepted unless a Certificate of Free Sale (FSC) from the country of origin is supplied. Samples of the new drug must be submitted to the Thai Department of Medical Science for analysis prior to acceptance of registration filings. This analysis usually takes 6 months. Once the file is received, the FDA can take up to 18 months ensuring that it is complete, to its satisfaction, before submitting the clinical work to the Review Committee for consideration. The Committee may ask additional questions or require that a local study be carried out to ensure that the clinical data can be duplicated in Thailand by Thai national companies under local conditions. The Thai FDA has implemented "user fees" to quicken the registration process and this policy has improved registration timing. However, these user fees are being politically challenged and may be eliminated in the near future. If this occurs, registration timing may fall back to the old two year filing term. The Ministry of Public Health has eliminated the requirement for sample analysis before filing of registration dossiers. The Ministry still requires an FSC to allow filings for imported products. An FSC is not required for regulatory filings where the product is to be based upon local production. PhRMA believes this is in contravention of WTO principles of national treatment. Government Pharmaceutical Organization This organization is exempted from registration and Good Manufacturing Practice requirements and has rights to an exclusive position in supplying government hospitals with products on the National List of Essential Drugs. PhRMA believes this also is in contravention of WTO principles regarding national treatment. Potential Exports/Foreign Sales From Thai-based sales data and from estimates based on the size and buying power of the Thai population, PhRMA estimates that the potential market for its companies could be US$70 million, if the aforementioned barriers were removed. -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Tue Jan 11 13:58:32 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 65E1121B89 for ; Tue, 11 Jan 2000 13:58:32 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id NAA03817; Tue, 11 Jan 2000 13:58:31 -0500 Sender: jamie@genoa.essential.org Message-ID: <387B7D2D.174E9C6F@cptech.org> Date: Tue, 11 Jan 2000 13:57:49 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Heallth@cptech.org, pharm-policy Cc: healthgap Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] PhRMA on generic perscribing in Indonesia The Dec 3, 1999 PhRMA NTE section on Indonesia is fairly extensive, and won't be repeated here now, but I found it interesting that a governemnt policy to promote generic perscribing is considered a barrier to trade under US trade laws. Jamie http://www.phrma.org/issues/intl/indonesia.html Generic Prescribing Although it is not actively promoted as much as it was in 1998, generic prescribing remains Government policy, with the potential for substantial adverse impact on PhRMA member firms operating in Indonesia. Generic prices of products produced by Government owned companies have been increased. -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Tue Jan 11 14:29:36 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 837C121B02; Tue, 11 Jan 2000 14:29:36 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id OAA04690; Tue, 11 Jan 2000 14:29:36 -0500 Sender: jamie@genoa.essential.org Message-ID: <387B8476.C2BCB0FE@cptech.org> Date: Tue, 11 Jan 2000 14:28:54 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Brazil decree on compulsory licensing in cases of national emergency One section of the Dec 3, 1999 PhRMA NTE submission describes an October 6, 1999 Brazilian Presidential degree permitting compulsory licensing in cases of national emergency. Jamie http://www.phrma.org/issues/intl/brazil.html "This is further aggravated by the October 6, 1999 issuance of a Presidential Decree regulating the implementation of Article 71 of the law, which governs the grant of compulsory licenses in broadly defined situations of national emergency. Beyond any definition-related concerns, this particular decree is troubling because of the absence of any dialogue with industry prior to its publication, the broad discretionary powers given to officials below the presidential level, the apparent inconsistency with TRIPs obligations, and subsequent potential benefit to domestic manufacturers, and the mandatory transfer of technology considered in Article 5." -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Tue Jan 11 14:41:57 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 3679A21B89; Tue, 11 Jan 2000 14:41:57 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id OAA04936; Tue, 11 Jan 2000 14:41:57 -0500 Sender: jamie@genoa.essential.org Message-ID: <387B875B.84CB21A8@cptech.org> Date: Tue, 11 Jan 2000 14:41:15 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy , healthgap Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] PhRMA says Mexico generic persscribing law has been "rectified" http://www.phrma.org/issues/intl/mexico.html A new law approved in July 1997 required doctors to write all pharmaceutical prescriptions using the generic name only, forbidding the use of the trademark, in potential violation of TRIPS Article 20. While this initiative has apparently been rectified, and substitution at point of sale is not permitted, this area will require close scrutiny in 1999. -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Wed Jan 12 08:58:26 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 3E78921AFF; Wed, 12 Jan 2000 08:58:26 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id IAA17366; Wed, 12 Jan 2000 08:58:26 -0500 Sender: jamie@genoa.essential.org Message-ID: <387C8860.45A48B04@cptech.org> Date: Wed, 12 Jan 2000 08:57:52 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Typo in URL for Domincan Republic NTE submission ------------------ Subject: Re: [Ip-health] PhRMA's Dec 3, 1999 NTE submission: Dominican Republic Date: Wed, 12 Jan 2000 11:01:36 +0100 From: "Mark Raijmakers, Wemos" Organization: Wemos Foundation To: James Love James, You made a small typicg mistake in the URL of the NTE submission on the Dom Rep. The correct URL is: http://www.phrma.org/issues/intl/dominican.html -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Thu Jan 13 10:27:49 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id F0DC521AFF; Thu, 13 Jan 2000 10:27:48 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id KAA06717; Thu, 13 Jan 2000 10:27:48 -0500 Sender: jamie@genoa.essential.org Message-ID: <387DEEDE.9EEC58DA@cptech.org> Date: Thu, 13 Jan 2000 10:27:26 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] African perspectives on funding for HIV treatments This story, posted on healthgap by Richard Jefferys, gives African perspectives on the funding of HIV/AIDS treatments. The most quotable comments were from Dr. Timothy Stamps, the Zimbabwe health minister, who compared the proposal for new aid to the estimated $600 billion the west spent on the Y2k computer bug. Jamie http://www.vancouversun.com/cgi-bin/newsite.pl?adcode=w-mm&modulename=world% 20news&template=international&nkey=vs&filetype=fullstory&file=/cpfs/world/00 0111/w011114.htmlLast updated: Tuesday 11 January 2000 Vancouver Sun: WORLD NEWS Africa urges wealthy countries to make AIDS drugs available, affordable UNITED NATIONS (AP) - African countries say wealthy countries should make HIV-fighting drugs available and affordable to residents of the continent, which has been hardest hit by AIDS yet has virtually no access to treatments saving lives in the industrial world. Many African health ministers and ambassadors attending a meeting of the Security Council on Monday applauded a new initiative by the United States to increase funding for AIDS prevention programs and vaccine research. At the meeting, U.S. Vice-President Al Gore announced that the White House was seeking an extra $150 million this year from Congress for vaccine research and prevention programs in Africa. African officials, however, said more money was needed, and that wealthy countries had an ethical imperative to give Africans access to HIV-fighting drugs. "It is immoral that the worst affected continent has the lowest access to care," said Namibia's health minister, Dr. Libertine Amathila. Many patents for HIV-fighting drugs are held by Western pharmaceutical companies, which have lobbied to block cheaper, generic versions from being manufactured. That has kept effective yet expensive drugs such as AZT and their generic versions out of the hands of most Africans. Zimbabwe's health minister, Dr. Timothy Stamps, said withholding such drugs constituted a violation of Africans' basic human rights - the right to health. And he questioned whether the practice was a result of sheer ignorance or a "new form of racial discrimination, another ethnic cleansing process." Stamps was similarly incredulous that the industrial world had just spent what he said was $600 billion US to ward off the Y2K computer bug "to eliminate the risk of some people losing some money, some places losing some data and some people disrupting their busy schedules." "To some of us in the real world, this only induces a sense of wonder that intelligent beings in the metropolitan countries can be so oblivious, so colour blind, to what has happened in the African continent over the past 15 years," he said. AIDS is now the leading killer in sub-Saharan Africa, a region where poverty and wars have already taken a heavy toll. In 1998, 200,000 people died as a result of armed conflicts in Africa, compared with 2.2 million from AIDS. An estimated 23.3 million Africans are currently infected with HIV or AIDS. "War fuels the epidemic," Dr. Peter Piot, head of the joint UN Program on HIV/AIDS, told the council in its first meeting ever on a health issue. "But undoubtedly the epidemic itself is now . . . causing social and economic crises which in turn threaten political stability." According to UN statistics, $165 million was spent on AIDS prevention in Africa in 1996, while estimates suggest that between $800 million and $2.5 billion a year is needed to mount effective prevention campaigns on the continent. The United States alone spends $10 billion annually in public and private money for AIDS research, prevention, care and treatment for the 40,000 people infected in America every year, the UN Development Program says. The AIDS activist group ACT-UP said the U.S. should allow poor countries access generic drugs that could reduce the cost of HIV-fighting medicines by as much as 90 per cent. ACT-UP similarly criticized Gore's $150 million spending announcement as a "drop in the funding bucket." Gore's appearance at the United Nations also drew some questions from reporters about whether the vice-president was merely bolstering his campaign to be the Democratic candidate for president by announcing some new U.S. initiatives. ---------------------------- AIDS Treatment Data Network 611 Broadway, Suite #613 New York, NY 10012 Tel: (800) 734-7104 Fax: (212) 260-8869 E-mail: network@atdn.org Internet: aidsinfonyc.org/network Affilation provided for purpose of identification, not representation. -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Thu Jan 13 11:57:01 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 60E5621B10; Thu, 13 Jan 2000 11:57:01 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id LAA08592; Thu, 13 Jan 2000 11:57:01 -0500 Sender: jamie@genoa.essential.org Message-ID: <387E03C7.4315880C@cptech.org> Date: Thu, 13 Jan 2000 11:56:39 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] article on PTO's new proposed guidelines for DNA patents http://www.ljx.com/cgi-bin/f_cat?prod/ljextra/data/texts/2000_0108_59.html PTO's new guide to DNA info Scientific community is in conflict on free use of early research. BY VICTORIA SLIND-FLOR NATIONAL LAW JOURNAL STAFF REPORTER The National Law Journal (p. B06) Monday, January 17, 2000 In response to some scientists' concerns about the rush to patent DNA segments, the U.S. Patent and Trademark Office (PTO) on Dec. 21 posted a new set of proposed examinations guidelines on its Web site. Jeffrey P. Kushan, a partner in the Washington, D.C., office of Atlanta's Powell, Goldstein, Frazer & Murphy L.L.P., said that these new utility guidelines should catch the attention of scientists and academics who espouse the purist view that very small DNA segments shouldn't be patented. The proposed change would affect the way examiners look at the "utility" of an invention, determining whether or not it serves some particular practical purpose. The PTO is accepting written comments on these guidelines until March 22. Claims as 'landfill' Under the new guidelines, examiners will look for "specific and substantial utility" in inventions. Mr. Kushan said that the PTO is addressing the proliferation of applications filed for very small DNA sequences in which the inventors merely claim the usefulness of a particular segment in that it helps researchers find other DNA segments. Some companies, he notes, are submitting as many as 6,000 applications for these separate small DNA segments. Mr. Kushan was a staff member at the PTO for 10 years and was a member of the office's 1992 Advisory Commission on Patent Law Reform. The guidelines use harsh language in discussing vague utility claims. The PTO says that "throwaway," "insubstantial" and "nonspecific" utilities claims for complex inventions are no more than "landfill." [snip] -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Thu Jan 13 18:11:24 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id B066221C13; Thu, 13 Jan 2000 18:11:22 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id SAA16824; Thu, 13 Jan 2000 18:11:22 -0500 Sender: jamie@genoa.essential.org Message-ID: <387E5B87.21852A4B@cptech.org> Date: Thu, 13 Jan 2000 18:11:03 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: ecommerce , Multiple recipients of list RANDOM-BITS , IP-Health list , pharm-policy , upd-discuss Content-Type: text/plain; charset=iso-8859-1 Content-Transfer-Encoding: 8bit Subject: [Pharm-policy] National Academies: IPRs, who far should they be extended? This is part of a pretty important National Academies program on intellectual property. Jamie --------------------------- Board on Science, Technology and Economic Policy The National Academies Intellectual Property Rights: How Far Should They Be Extended? Wednesday, February 2 & Thursday, February 3, 2000 Lecture Room National Academy of Sciences 2100 C Street, NW Washington, DC This conference will bring together Federal judges, executive branch officials, practitioners, corporate executives, legal scholars, and economists to discuss the effects on innovation and economic performance of extending intellectual property rights. Confirmed speakers include Hon. Randall Rader, U.S. Court of Appeals for the Federal Circuit Hon. Todd Dickinson, Commissioner of Patents and Trademarks Hon. Fern Smith, Federal Judicial Center and U.S. District Court for the Northern District of California Hon. Roderick McKelvie, U.S. District Court for the District of Delaware Richard Levin, President, Yale University Mark Myers, Senior Vice President, Xerox F.M. Scherer, Harvard Kennedy School of Government John Barton, Stanford University Law School Robert Merges, Boalt Hall Law School, University of California at Berkeley Sessions will examine recent IP developments and strategies in key sectors. Panel discussions will consider several cross-cutting issues: Wednesday, February 2 · IPRs in semiconductors · Technology development, competition and antitrust policy · IPRs in software and business methods · Patent standards, quality and scope · IP protection and knowledge transfers Thursday, February 3 · IPRs in biotechnology: pharmaceutical and agricultural applications · IP right to tools and results of fundamental research · Patent administration and litigation · Summary A current agenda may be found attached or on the STEP Board's website (www.nationalacademies.org/ipr). Registration is complimentary by (1) return email, (2) fax to 202-334-1505, or (3) completing the form on the website. For more information call Craig Schultz at 202-334-2200 or email to . We encourage you to refer this announcement to others who may be interested in joining us. (See attached file: 01-11agenda.doc) -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Thu Jan 13 19:44:24 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id F136621B0C; Thu, 13 Jan 2000 19:44:23 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id TAA18408; Thu, 13 Jan 2000 19:44:23 -0500 Sender: jamie@genoa.essential.org Message-ID: <387E7155.E35471B0@cptech.org> Date: Thu, 13 Jan 2000 19:44:05 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] January 12, 2000 meeting with USTR, DHHS, and USPTO Yesterday (January 12, 2000) several members of the Health Gap Coalition, MSF and other NGO's meet with USTR, US PTO and DHHS to talk about the new trade policy. Others will have their own reports of what happened. I don't want to go into everything that was discussed, but I would say that the meeting was pretty frank and I thought a good start. Paul Davis and Julie David did a nice job of getting the meeting and moving things along, and all of the participants made useful contributions. There were discussions of general principles, plus several country cases. We had decided going in to focus in particular on four country cases, including Thailand, the Dominican Republic, the Philippines, and Kenya, with each case illustrating a somewhat different point. As a general matter, the Health Gap/MSF/etc coalition told the US government that it looked forward to concrete actions following the President and Vice President's dramatic announcements. Julie David chaired the meeting from our side, and USTR's Joe Papovich chaired the government's side. Eric Sawyer and Dr. David Hoos made introductory statements about the concerns regarding patient access to medicines, and our expectation that USTR would not only consider public health in new disputes, but would pro-actively address the impact of past policies. This was a segue into a discussion of the Thailand case, where a decade of US pressure had led to several changes in Thai statutes and policies, making access to medicines more difficult. Dr. Joelle Tanguy from MSF (Doctors without Borders) explained that the activists in Thailand were continuing a series of protests, and that they were asking the US government to send a signal to the Thailand government that there would be no punitive trade pressures if the Thailand government issued a compulsory license for ddI, and HIV/AIDS drug. Several persons emphasized the fact that the Thai government had been profoundly intimated by the US government, and a positive signal was needed, to clarify that there really had been a change in policy. This case is seen as a test, to see if Clinton/Gore are serious about making HIV/AIDS drugs more available. Toby Kasper and others asked that we receive any copies of correspondence with the Thai government on this issue. The next country discussion concerned the Dominican Republic (DR), which is a new dispute over a pending bill that would authorize compulsory licensing. USTR had been asked to bring information to the meeting about the DR dispute, but was not prepared to provide much information about the trade dispute, even though the DR has been on the 301 list over this proposed law since last spring. However, it did seem as though the US was objecting to the fact that the DR law would make it fairly straightforward to get a compulsory license (CL) in the DR, after a 180 day negotiation. 180 days (for a patent owner to say no to a voluntary license) didn't seem very short to me. I brought up the fact that the Dominican Republic is very poor (about 6 percent of US per capita income), has a significant HIV/AIDs population (about 83,000 persons, or about 1 percent of the population in 1997) and that it doesn't have the huge legal system infrastructure that we have in the USA, and that it was a positive thing if the DR law was designed so that the compulsory licenses would actually be issued. So long as the patent owners were compensated, I didn't think the US should object to a system that was administratively fast tracked. Eric Sawyer said the Caribbean was among the regions of the world were HIV/AIDS was growing very fast. USTR was asked to provide information about the DR law and the US position and lobbying efforts. "We should be able to know what US foreign policy is," I said, "and see the basis for US trade pressures." Julie David said that this was a test both of the willingness of the Administration to implement the new policy, and to see if they would make the policy process more transparent. Julie David talked about the Philippines case, where the US government has complained about programs on generic drugs, and mentioned the US is engaged in similar disputes involving Mexico, Thailand, South Africa, and elsewhere. USTR was not willing or prepared to talk about the various disputes over generic drug prescribing, except to say that in the past the US has objected to proposals for mandatory prescribing by generic name and for printing in large type the generic name, on the grounds that this violates trademark rights. It was mentioned (not by USTR) that the US FDA has its own rules requiring the use of generic names on packages, and lots was said about the hypocrisy and wrong headedness of attacks on generic substitution. We asked for more details on the US lobbying efforts on the Philippines proposals. Eric Sawyer talked about the Kenya case where Pfizer was threatening legal action against MSF (Doctors without Borders) if they brought cheap copies of fluconazole across the boarder. We asked that the President issue an executive order to prevent Pfizer from getting access to various US taxpayer funded inventions and research, if Pfizer continued to create barriers for access to life saving drugs. There was discussion of Pfizer's high prices for fluconazole. This case was discussed to see if the US government could use its power in a positive way, to stop companies from making things worse. It was mentioned that the President has already used his executive power in the procurement and grants and contracts areas for other policy objectives. Paul Davis and others discussed the new public health review of trade policy. Joe Papovich and Dr. Tom Novotny both described the US process, which isn't finalized yet, but seems to involve adding a new element of review with the Administration. The US government was told that we were opposed to the idea that countries would face TRIPS Plus requirements for medicines, unless they could make a special (and compelling) case to DHHS. Also, there was a long discussion about the infrastructure issue that I can't do justice to here in these brief notes. I will say that we were opposed to the idea that the poorest countries would not qualify for compulsory licensing, under the new policy, if DHHS didn't like the quality of the infrastructure. We went back and forth over complaining about this type of colonialism, and offering suggestions on how to make it work better -- an awkward discussion at best. I talked briefly about how difficult it was to get governments to spend money to treat HIV/AIDS patients, and how in many countries there is enormous discrimination against HIV/AIDS patient, due to a variety of social stigmas and taboos. And how frustrating it was that our own government would put pressure on poor countries not to solve HIV/AIDS problems -- after they finally were willing to act. At one point there was a discussion of having the US government issue green papers, leading to white papers, outlining US policy on various disputes, to make trade policy more transparent and to benefit from a more serious policy debate. The US government officials were serious and frank, and I thought it was a constructive exchange. While we were clearly expressing concern that big public announcements were not consistent with policy on the ground, it was also clear that this was a much different meeting than we had ever had with the Administration, and that much progress has been made. It's late and I have to go home. There was much more done, and I apologize for leaving so much out. Jamie -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Thu Jan 13 19:52:09 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by venice.essential.org (Postfix) with ESMTP id AE6FB21B0C; Thu, 13 Jan 2000 19:52:09 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by milan.essential.org (8.9.3/8.9.3) with ESMTP id TAA25268; Thu, 13 Jan 2000 19:52:09 -0500 Date: Thu, 13 Jan 2000 19:52:09 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: pharm-policy@venice.essential.org, ip-health@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] January 12, 2000 USTR, USPTO, DHHS meeting (formatting fixed) Yesterday (January 12, 2000) several members of the Health Gap Coalition, MSF and other NGO's meet with USTR, US PTO and DHHS to talk about the new trade policy. Others will have their own reports of what happened. I don't want to go into everything that was discussed, but I would say that the meeting was pretty frank and I thought a good start. Paul Davis and Julie David did a nice job of getting the meeting and moving things along, and all of the participants made useful contributions. There were discussions of general principles, plus several country cases. We had decided going in to focus in particular on four country cases, including Thailand, the Dominican Republic, the Philippines, and Kenya, with each case illustrating a somewhat different point. As a general matter, the Health Gap/MSF/etc coalition told the US government that it looked forward to concrete actions following the President and Vice President's dramatic announcements. Julie David chaired the meeting from our side, and USTR's Joe Papovich chaired the government's side. Eric Sawyer and Dr. David Hoos made introductory statements about the concerns regarding patient access to medicines, and our expectation that USTR would not only consider public health in new disputes, but would pro-actively address the impact of past policies. This was a segue into a discussion of the Thailand case, where a decade of US pressure had led to several changes in Thai statutes and policies, making access to medicines more difficult. Dr. Joelle Tanguy from MSF (Doctors without Borders) explained that the activists in Thailand were continuing a series of protests, and that they were asking the US government to send a signal to the Thailand government that there would be no punitive trade pressures if the Thailand government issued a compulsory license for ddI, and HIV/AIDS drug. Several persons emphasized the fact that the Thai government had been profoundly intimated by the US government, and a positive signal was needed, to clarify that there really had been a change in policy. This case is seen as a test, to see if Clinton/Gore are serious about making HIV/AIDS drugs more available. Toby Kasper and others asked that we receive any copies of correspondence with the Thai government on this issue. The next country discussion concerned the Dominican Republic (DR), which is a new dispute over a pending bill that would authorize compulsory licensing. USTR had been asked to bring information to the meeting about the DR dispute, but was not prepared to provide much information about the trade dispute, even though the DR has been on the 301 list over this proposed law since last spring. However, it did seem as though the US was objecting to the fact that the DR law would make it fairly straightforward to get a compulsory license (CL) in the DR, after a 180 day negotiation. 180 days (for a patent owner to say no to a voluntary license) didn't seem very short to me. I brought up the fact that the Dominican Republic is very poor (about 6 percent of US per capita income), has a significant HIV/AIDs population (about 83,000 persons, or about 1 percent of the population in 1997) and that it doesn't have the huge legal system infrastructure that we have in the USA, and that it was a positive thing if the DR law was designed so that the compulsory licenses would actually be issued. So long as the patent owners were compensated, I didn't think the US should object to a system that was administratively fast tracked. Eric Sawyer said the Caribbean was among the regions of the world were HIV/AIDS was growing very fast. USTR was asked to provide information about the DR law and the US position and lobbying efforts. "We should be able to know what US foreign policy is," I said, "and see the basis for US trade pressures." Julie David said that this was a test both of the willingness of the Administration to implement the new policy, and to see if they would make the policy process more transparent. Julie David talked about the Philippines case, where the US government has complained about programs on generic drugs, and mentioned the US is engaged in similar disputes involving Mexico, Thailand, South Africa, and elsewhere. USTR was not willing or prepared to talk about the various disputes over generic drug prescribing, except to say that in the past the US has objected to proposals for mandatory prescribing by generic name and for printing in large type the generic name, on the grounds that this violates trademark rights. It was mentioned (not by USTR) that the US FDA has its own rules requiring the use of generic names on packages, and lots was said about the hypocrisy and wrong headedness of attacks on generic substitution. We asked for more details on the US lobbying efforts on the Philippines proposals. Eric Sawyer talked about the Kenya case where Pfizer was threatening legal action against MSF (Doctors without Borders) if they brought cheap copies of fluconazole across the boarder. We asked that the President issue an executive order to prevent Pfizer from getting access to various US taxpayer funded inventions and research, if Pfizer continued to create barriers for access to life saving drugs. There was discussion of Pfizer's high prices for fluconazole. This case was discussed to see if the US government could use its power in a positive way, to stop companies from making things worse. It was mentioned that the President has already used his executive power in the procurement and grants and contracts areas for other policy objectives. Paul Davis and others discussed the new public health review of trade policy. Joe Papovich and Dr. Tom Novotny both described the US process, which isn't finalized yet, but seems to involve adding a new element of review with the Administration. The US government was told that we were opposed to the idea that countries would face TRIPS Plus requirements for medicines, unless they could make a special (and compelling) case to DHHS. Also, there was a long discussion about the infrastructure issue that I can't do justice to here in these brief notes. I will say that we were opposed to the idea that the poorest countries would not qualify for compulsory licensing, under the new policy, if DHHS didn't like the quality of the infrastructure. We went back and forth over complaining about this type of colonialism, and offering suggestions on how to make it work better -- an awkward discussion at best. I talked briefly about how difficult it was to get governments to spend money to treat HIV/AIDS patients, and how in many countries there is enormous discrimination against HIV/AIDS patient, due to a variety of social stigmas and taboos. And how frustrating it was that our own government would put pressure on poor countries not to solve HIV/AIDS problems -- after they finally were willing to act. At one point there was a discussion of having the US government issue green papers, leading to white papers, outlining US policy on various disputes, to make trade policy more transparent and to benefit from a more serious policy debate. The US government officials were serious and frank, and I thought it was a constructive exchange. While we were clearly expressing concern that big public announcements were not consistent with policy on the ground, it was also clear that this was a much different meeting than we had ever had with the Administration, and that much progress has been made. It's late and I have to go home. There was much more done, and I apologize for leaving so much out. Jamie ------------------------------- James Love Center for Study of Responsive Law | Consumer Project on Technology P.O. Box 19367, Washington, DC 20036 | http://www.cptech.org Voice 202/387-8030 | Fax 202/234-5176 | love@cptech.org From owner-pharm-policy@venice.essential.org Thu Jan 13 20:15:07 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by venice.essential.org (Postfix) with ESMTP id BFD0E21B0C; Thu, 13 Jan 2000 20:15:06 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by milan.essential.org (8.9.3/8.9.3) with ESMTP id UAA25582; Thu, 13 Jan 2000 20:15:06 -0500 Date: Thu, 13 Jan 2000 20:15:05 -0500 (EST) From: Robert Weissman To: ip-health@venice.essential.org, pharm-policy@venice.essential.org Cc: Treatment-access forum Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=X-UNKNOWN Content-Transfer-Encoding: QUOTED-PRINTABLE Subject: [Pharm-policy] APARTHEID OF PHARMACOLOGY - Le Monde diplomatique (fwd) Le Monde diplomatique =09=09=09=09 January 2000 APARTHEID OF PHARMACOLOGY Twenty-two million people in Africa are seropositive - 65% of all the peo- ple infected with the Aids virus world wide. South Africa, which is particu= - larly badly affected, has made fighting the scourge a priority. But rather= =20 than help, in their determination to protect their patents, the pharmaceutical=20 laboratories are putting treatment beyond the reach of the poorest patients= =20 and countries. =09by Martine Bulard* Sleeping sickness, which is transmitted by the tsetse fly, is making a come= - back, killing 150,000 people every year, especially in Africa. There is a= =20 treatment, eflornithine (Ornidyl), developed by the American firm Merell=20 Dow in 1985. Costing a small fortune, it was beyond the reach of those=20 most seriously affected and was subsequently abandoned. Having=20 "inherited" the drug when it took the company over, Hoechst Marion Rous- sel has finally agreed to transfer marketing rights to the World Health Or- ganisation (WHO). But the WHO lacks the resources to manufacture it.=20 After three years of talks, the French humanitarian agency M=E9decins sans= =20 fronti=E8res (MSF), together with other non-governmental organisations, is= =20 hoping that the product will be available, in some places at least, at the very=20 start of this year. But if it is to continue to be available, a sponsor will have=20 to be found. Microsoft Chairman Bill Gates is a possible candidate.=20 The remedy for bacterial meningitis, which is particularly prevalent in the= =20 countries of the South, has not been so lucky. Doctors saw chlorampheni- col in oil as having the advantage of being both cheap and easy to use. In= =20 1995 Roussel Uclaf (which merged with the Hoechst group in 1997 to=20 form HMR) stopped making it. Initially, the International Development As- sociation got it transferred to a laboratory in Malta. But now the money ha= s=20 run out. The molecule to treat leishmaniosis, a common parasitic disease in Africa= =20 resulting in very severe skin lesions or death, is no more profitable. It exists=20 in the laboratory, but has not gone into production because there is no gua= r- antee of a "return on the investment". The list of molecules discovered but= =20 which got no further than the laboratory and of useful medicines abandoned= =20 is a long one. Dr Bernard P=E9coul, MSF's drugs project coordinator, notes= =20 that, of 1,223 molecules placed on the market between 1975 and 1997,=20 only 13 are aimed specifically at tropical diseases. And only five are the= =20 outcome of veterinary research (1). Now that many diseases, such as malaria, sleeping sickness or tuberculosis,= =20 that had been thought to have been conquered are coming back in force,=20 more virulent than before, the old medicines are no longer always effective= ,=20 since more and more bacilli are showing multiple resistance, whilst the cos= t=20 of new remedies is exorbitant. As a result, no serious research is being ca= r- ried out into a vaccine to replace the good old BCG, even though eight=20 million more people are infected every year. Of these, the number of pa- tients - or should we say customers? -- able to pay is estimated by MSF at= =20 400,000, way below the threshold required to launch an investment.=20 Somewhere in the world, someone is dying of tuberculosis every ten sec- onds (2).=20 For a medicine to be produced commercially, not only does it need a large= =20 market (three quarters of the population), but it must also make money. A= =20 lot of money. As quickly as possible. As World Health Organisation=20 (WHO) Director General Dr Gro Harlem Brundtland herself says, "More=20 than a billion fellow human beings have been left behind in the health=20 revolution" (3). In fact four fifths of world health expenditure goes on one fifth of the world=20 population. While drug sales in North America and, to a lesser extent,=20 Europe, mushroomed between 1993 and 1999, in the countries of Africa=20 and Asia (excluding Japan) they declined (see chart). In the case of Aids,= =20 the picture is even more devastating: 92% of the world population have to= =20 make do with only 8% of total expenditure. "If the rich countries do nothing," Professor Fran=E7ois Bricaire, head of = the=20 parasitology and tropical diseases department of the Piti=E9-Salp=EAtri=E8r= e=20 Hospital in Paris, warns, "this human imbalance will result in an explosion= =2E=20 People know that, on the one hand, there are medicines to conquer the dis- ease and that, on the other, they are denied them for lack of resources." F= or=20 example, triple therapy (the combination of three types of antiretroviral= =20 drugs), which has cut the Aids mortality rate by 60% in the West, is virtu- ally inaccessible in the countries of the South. "We get patients coming to us from Africa who have saved every penny to=20 pay for their treatment," Professor Bricaire adds. "We get them back on=20 their feet knowing full well that most of them will not be able to afford t= o=20 continue their treatment once they return home. And then there are those=20 who arrive illegally. We cannot just abandon them to their fate, so we=20 muddle through, but it is too random to be satisfactory." Drugs are not everyday products According to the World Bank, the number of Aids-related deaths in Africa=20 will soon exceed the 20 million victims of the plague that ravaged Europe= =20 between 1347 and 1351 (4). With the simple difference that in those days=20 they did not know how to handle the crisis. Today science is capable of=20 dealing with epidemics. Many try to conceal this reality by highlighting th= e=20 lack of a reliable health infrastructure in those countries.=20 They say that some long-term treatments like triple therapies against Aids= =20 would be impossible there, or even dangerous. The obstacles are real=20 enough: in some countries, wars and population movements have destroyed=20 the health care system; in others, the policies imposed by the Internationa= l=20 Monetary Fund and the World Bank have had much the same result by re- quiring drastic public expenditure cuts. It is ironic to see the same people who helped to dismantle the health-care= =20 structures turning down emergency programmes on the strength of those=20 systems' very shortcomings. Not only could health care networks be rebuilt,= =20 but there are already premises and staff (local and expatriate doctors and= =20 nurses) qualified to treat conventional infectious diseases and start long- term treatments for Aids. Provided they have access to the latest medicines= =20 at affordable prices.=20 The pharmaceutical industry does not seem to be about to turn over a new=20 leaf. National Pharmaceutical Industry Association director-general Ber- nard Lemoine does not hide his annoyance at the campaign being waged on=20 this issue. He stresses the positive things being done by the laboratories:= =20 temporary price reductions, donation of unused molecules, grants to foun- dations. But his conclusion is nevertheless final: "I don't see why special ef- fort should be demanded from the pharmaceutical industry. Nobody asks=20 Renault to give cars to people who haven't got one." But that is just it:= =20 drugs are not everyday products. Not only do the pharmaceuticals companies set their own prices and select= =20 the markets that will push their share prices up, but they oppose every out= - side initiative. Before the first half of 1998 Thailand had only one drug,= =20 fluconazole, to treat cryptococcal meningitis, a fatal disease often associ= - ated with Aids; it was manufactured locally by the American laboratory=20 Pfizer under the name Triflucan. It was effective, but extremely expensive:= =20 12,000 bahts (around $330) for a pack of 50 tablets. For a patient starting= =20 treatment, that meant a monthly outlay of 15,000 bahts, one and a half=20 times an executive's salary. Finally, two Thai companies managed to put on= =20 sale an equivalent product for 4,000 to 4,500 bahts a pack. Still too expen= - sive for much of the population, but much more affordable than Triflucan.= =20 Six months later sales were banned: alerted by Pfizer, the United States=20 government had threatened the Thai authorities that it would impose a duty= =20 on their main exports (timber, jewellery, microprocessors) if they did not= =20 stop making fluconazole. South Africa almost suffered the same fate. In 1997 the government passed= =20 some health laws allowing local firms to produce treatments for Aids or to= =20 import them bypassing the big corporations' patents. At once the big=20 American pharmaceutical companies, some of which have subsidiaries in=20 the Cape, complained, then pressed their government to take reprisals of=20 the same kind as inflicted on Thailand. Vice-president Al Gore, head of the= =20 US-South Africa Binational Commission, took the matter in hand himself. As soon as the confrontation began, the Aids organisations (Act Up-New=20 York) and James Love and Ralph Nader's Consumer Project on Technol- ogy began lobbying the US leadership. Gore was unable to hold a single=20 public meeting for the presidential election without being questioned on th= e=20 subject. This campaign, coupled with the South African government's te- nacity, resulted in the Clinton administration abandoning all proceedings= =20 and retaliatory measures in September. The laboratories rushed to withdraw= =20 their complaints. True, it will probably be some time before South Africa= =20 produces its first generic medicine, but the first battle has been won.=20 To measure the scale of the victory, we must look at the changes made to=20 the world trade rules since the World Trade Organisation (WTO) was set=20 up (5). Up until 1994 every country was free to make its own health policy= =20 and produce generic medicines without waiting for the patent to fall into= =20 the public domain. India, Egypt and Argentina, for example, were able to=20 pursue a policy of import substitution and create a local pharmaceutical in= - dustry. Since 1994, the members of the WTO have had to submit to the so-called=20 Trips agreements on trade-related aspects of intellectual property rights.= =20 Under this agreement it is, in general, no longer possible to manufacture a= =20 drug or buy it abroad without the permission (granted in return for payment= =20 of royalties) of the owner of the invention, who holds this power for 20=20 years. As a result of pressure from countries like Spain and Canada (6),=20 however, the Trips do contain exception clauses: in the event of a medical= =20 emergency or hindrances to competition (inventor's refusal to sell or exces= - sively high prices), every government is entitled to have recourse to=20 "compulsory licences" and parallel imports. Compulsory licences allow a=20 product to be manufactured without the inventor's consent, while parallel= =20 imports allow it to be bought wherever it is sold the cheapest.=20 South Africa, where according to the WHO one adult in six is seropositive,= =20 is an obvious case of medical emergency. The big pharmaceuticals corpo- rations know that. But, as Pharmaceutical Research and Manufacturers of=20 America (PhRMA) spokesman Jeffrey Trewhitt bitterly comments, these=20 South African laws "could set a very, very bad precedent that could un- dermine legitimate patent protection around the world. The potential harm= =20 from these recent developments can be expected to reach into many other=20 developing countries" (7). Furthermore, all the emergent nations are subject to unbelievable pressures= =2E=20 Under WTO rules, India, where only one third of the population has access= =20 to drugs, should abandon price controls and the production of generic=20 medicines. It is easy to see that this would result in small firms closing= =20 down and even fewer people having access to medical care. Yet the indus- try journal Pharmaceutiques says that "the reforms and the liberalisation= =20 that are under way are opening up new prospects for pharmaceutical labo- ratories" (8). It is certainly too early to draw detailed lessons from the Trips agreement= s.=20 But we already know the damage that was caused when the countries of=20 Latin America were forced to deregulate in 1988. According to the WHO,=20 drug prices escalated by 44% in Mexico, 24% in Brazil and 16.6% in Ar- gentina in the space of four years.=20 But the pharmaceutical lobbies are hoping to use the WTO to get all ex- ceptions to patent rights abolished. At the same time, they want greater ac= - cess, without cost and without constraint, to the plant life of the developing=20 countries, since knowledge of their genomes is one of the keys to future=20 medicines. In other words, they want complete control over the raw mate- rials and ever tighter protection for the discoveries made from those plant= s,=20 making them inaccessible to the countries they came from (9). In addition patents are being filed further and further upstream, which, Pr= o- fessor Axel Kahn, former chairman of the French National Consultative=20 Committee on Ethics, explains, is "a considerable handicap on freedom to=20 create". Until recently, he argues, "a distinction was made between knowl- edge that is discovered and belongs to us all and products or processes tha= t=20 are invented and can be patented" (10). Protecting earlier reduces the scop= e=20 of common knowledge. At present, there is five to ten times more informa- tion on genomes in private, limited access, data banks that have to be paid= =20 for than is freely accessible in the public domain. As a result, a number o= f=20 American doctors and researchers say in an open letter, the use of patents= =20 or the exorbitant cost of licences to prevent doctors and medical laborato- ries from conducting genetic tests is restricting access to care, lowering its=20 quality and pushing up costs unreasonably (11).=20 We are moving towards a situation where a handful of firms have a mo- nopoly on life and have seized control of genetic diversity. There is a gre= at=20 danger that the rich countries will officially become a technological and f= i- nancial directorate, a sort of "G8" for drugs, deciding everything, from th= e=20 level of research to whether or not a particular product will be launched.= =20 That would make the imbalances even worse: the developed countries, with=20 plenty of money to spend, would have the latest treatments, very expensive= =20 and protected by intellectual property rights. The others could benefit fro= m=20 them when the patent rights were exhausted - 20 years and several hundred= =20 thousand deaths later. Non-governmental organisations, associations of people suffering from=20 various diseases, doctors and researchers are mobilising against these dan- gers. If they differ on strategy, all are agreed that at the very least the ex- ceptions provided for in the current Trips agreements must be preserved in= =20 the millennium round talks. This basic minimum could, MSF suggests, give=20 them time to get a "health exception", just as there is already a "cultural ex- ception". Patent law cannot be placed above humanity's basic needs. It=20 would be perfectly sensible to decide that human genome and biodiversity=20 research should be "global public goods". Monuments like the Angkor Wat=20 temple or cities such as Venice are considered part of human heritage. Why= =20 not human genetics? Likewise, a stop must be put to the plundering of the= =20 third world: not only should a fee be paid for using plants originating in= =20 those countries, but they should all be guaranteed the benefit of treatment= s=20 developed from those plants. Without waiting for that, how can we fight the epidemics that are devastat- ing the peoples of the poor countries? Prices could be cut quickly to make= =20 drugs accessible without jeopardising the financial health of the pharma- ceuticals corporations: those based in France, for example, spend nearly as= =20 much on advertising and promotion as on research: 11.3% as against 14%=20 of turnover respectively (12). German Vel=E1squez, Sara Bennett and Jonathan Quick, who have been=20 studying health care systems for the WHO for a long time, say that, unlike= =20 the rest of health care, the pharmaceuticals sector is experiencing serious= =20 problems owing to the lack of competition (13). This has an effect on=20 prices. In fact two thirds of the world market are in the hands of about 20= =20 large groups. And concentration is proceeding apace, as evidenced by the=20 merger of HMR and Rh=F4ne Poulenc, or the current link-up between Swit- zerland's Novartis and US giant Monsanto. Of the 25 drugs most widely=20 sold, 20 are American. There is more or less a single world price, based on= =20 those charged in the US, which are among the highest in the world. Some,=20 like Dr P=E9coul, propose that a tax should therefore be levied on the phar= - maceuticals companies' profits, the proceeds of which would go into a fund= =20 to pay for research into tropical diseases and the production of essential= =20 medicines. Research hampered by patents While the pharmaceuticals groups carry a tremendous responsibility, inter- national organisations and governments must not be let off the hook.=20 France, at least, has shown some signs of action: it has taken part in the= =20 United Nations Programme on HIV/Aids (UNAids); it was behind the=20 creation of the International Therapeutic Solidarity Fund, which has=20 brought a lot of hope to the poorer countries. But these programmes have=20 come to a standstill. France has thrown in the towel, Europe is doing noth- ing and the US refuses to take part in most collective actions of any size. For its part the WHO is now supporting countries making use of=20 "compulsory licences", but it is still far behind what is needed. It remain= s=20 prisoner to an opaque method of operating and an outdated view of its role.= =20 This hampers its ability to innovate and formulate new objectives for world= =20 health. Of course the lack of funding is just as crucial. But it would be= =20 possible to design emergency programmes making drugs available to health=20 care professionals in the poor countries at cost price or less. The difference=20 would be paid by the pharmaceuticals companies, the governments of the=20 countries concerned and by the developed countries. After all, such a model= =20 was adopted in the 1950s and 1960s to fight smallpox, which has been=20 eradicated since 1977. "Financial prudence is not the real enemy," Nobel Prize-winning economist= =20 Amartya Sen explains, but "the use of public resources for purposes where= =20 the social benefits are very far from clear, such as the massive expenses= =20 that now go into the military in one poor country after another. It is an indi- cation of the topsy-turvy world in which we live that the doctor, the=20 schoolteacher or the nurse feels more threatened by financial conservatism= =20 than does the general and the air marshall" (14). And he adds: "the price o= f=20 inaction and apathy can be illness and death". * Journalist (1) Bernard P=E9coul, Pierre Chirac, Patrice Trouille, Jacques Pinel, "Acce= ss=20 To Essential Drugs In Poor Countries. A Lost Battle?", Journal of the=20 American Medical Association, Chicago, vol. 281, 27 January 1997. See=20 also the dossier in the journal Messages, no. 102, January-February 1999,= =20 published by M=E9decins sans fronti=E8res, 16 rue Saint Sabin, 75011 Paris.= =20 http//www.msf.org/ (2) Figures provided by the WHO. Note that 98.8% of victims live in third= =20 world countries. (3) Dr Gro Harlem Brundtland, statement to the 52nd world health assem- bly, "Looking ahead for WHO after a year of change", World Health Re- port, WHO, Geneva, March 1999. (4) "Intensifying action against HIV/AIDS in Africa", World Bank - Africa= =20 Region, Geneva, June 1999. (5) See Le Monde diplomatique, November 1999. See also Andr=E9 Ferron,=20 Philippe Herzog, Bernard Marx, "Pour un contr=F4le social du cycle du=20 Mill=E9naire =E0 l'OMC", L'Option de Confrontations, Montreuil, November=20 1999. (6) Spain did not fully recognise the patenting system for drugs until 1992= ,=20 Canada in 1993. (7) Quoted by Mike McKee, "Tripping over Trips", IP Magazine, San=20 Francisco, September 1999. http://www.ipmag.com/ (8) Jean-Jacques Cristofari, "Facettes indiennes aux 23,700 firmes pharma- ceutiques", Pharmaceutiques, Paris, no. 53, January 1998. (9) Jean-Paul Mar=E9chal, "Making merchandise of biodiversity", Le Monde=20 diplomatique, English edition, July 1999. (10) Axel Kahn, Et l'homme dans tout cela, NIL, Paris, to be published in= =20 February 2000. (11) See The Guardian, London, 15 December 1999. (12) "L'industrie pharmaceutique: r=E9alit=E9s =E9conomiques 1999", documen= t=20 published by the Syndicat national de l'industrie pharmaceutique (SNIP),=20 88 rue de la Faisanderie, Paris. (13) German Vel=E1squez, Sarah Bennett and Jonathan D. Quick, "R=F4les des= =20 secteurs public et priv=E9 dans le domaine pharmaceutique. Incidences sur= =20 l'=E9quit=E9 en mati=E8re d'acc=E8s et sur l'usage rationnel des m=E9dicame= nts", WHO,=20 Geneva, 1997. (14) Amartya Sen, "Health and development", keynote address to the 52nd=20 world health assembly, Geneva, May 1999. Translated by Malcolm Greenwood From owner-pharm-policy@venice.essential.org Fri Jan 14 14:20:47 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 09B5321B17; Fri, 14 Jan 2000 14:20:47 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id OAA31247; Fri, 14 Jan 2000 14:20:46 -0500 Sender: jamie@genoa.essential.org Message-ID: <387F7704.605BA7DF@cptech.org> Date: Fri, 14 Jan 2000 14:20:36 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] TACD statement on Access to Medicines in Developing Countries This is a first draft of a TACD statement on Access to Medicines in Developing Countries. Suggestions are welcome. TACD will be meeting in Washington, DC on Feb 10, 2000. (See http://www.tacd.org for background on TACD). Jamie Love version 1.0 Pharmaceuticals 1. Access to Medicines in developing countries. a. Developing countries are facing a crisis in access to essential medicines. Large disparities in incomes have contributed to a crisis in terms of access to essential medicines in developing countries. Consider the following: - 1.3 billion people in the world live on less than US$1 per day 20% of the world's population consumes 80% of the world's resources - Every 3 seconds a child dies of diseases of poverty - 17 million deaths per year are due to infectious disease - Currently 33 million people live with HIV, 7-8 million with active TB - More than 90% of all death and suffering from infectious diseases occurs in the developing world - 20% of the world's population uses 80% of the world-wide production of medicines - 0.2% of pharmaceutical research is devoted to acute respiratory infections, TB, diarrhoea, while 18% of deaths are attributable to these diseases. b. Trade disputes involving health care are common. Since 1997, South Africa has been attempting to implement legislation to provide fast track mechanisms for compulsory licensing and parallel importing of essential medicines. South Africa is engulfed in a tragic health care crisis, with an estimated 20 percent of its young adults testing positive for HIV/AIDS. During the past three years, the US government, the European Commission, and officials from the United Kingdom, Germany and France have pressured South Africa to modify or repeal sections of its Medicines Act that would facilitate fast track compulsory licensing and parallel importing of essential medicines. There have been similar pressures on Thailand, a country with 1 million HIV/AIDS patients, and many other poor countries. The Dominican Republic, which faces a growing HIV/AIDS problem and an under funded public health effort, is currently being pressured over proposed fast tract compulsory licensing legislation. India is being pressured over proposals for fast tract compulsory licensing. The Philippines, Mexico, Thailand, South Africa, Indonesia and other countries have been pressured over proposals to promote the use of generic names in prescriptions and package labeling. There are also trade disputes over price controls, early working of patents, research exemptions, scope of patents, the timing of adherence to new WTO rules regarding intellectual property, the period of exclusivity for health registration data and many other issues. c. Public Health Considerations should be paramount in trade policies as they relate to access to medicines. The US and EU governments should review trade policies to ensure that developing countries do not face trade related barriers for access to essential medicines and other medical technologies. This is consistent with the World Health Assembly's endorsement EB103/4, which called upon member countries: (1) to reaffirm their commitment of developing, implementing and monitoring national drug policies and to taking all necessary concrete measures in order to ensure equitable access to essential drugs; (2) to ensure that public health interests are paramount in pharmaceutical and health policies; and (3) to explore and review their options under relevant international agreements, including trade agreements, to safeguard access to essential drugs; On December 1, 1999, the United State government announced a new initiative to incorporate public health considerations into trade policy, and to modify its trade policy in order to ensure broader access to medicines for HIV/AIDS and other illnesses. The EU and its member countries should do the same. d. R&D on neglected diseases. Today there is very little research and development on diseases such as malaria, chagas disease and other illnesses that primarily impact the poor. The US, the EU and other developed countries should enter into an agreement to support far higher levels of R&D on these diseases. Moreover, these R&D efforts should be designed with access in mind, and address issues such as reasonable pricing and the allocation of intellectual property rights. e. Access to publicly supported R&D Public health groups have called upon the US and the EU and its member countries to enter into agreements with the World Health Organization (WHO) to give the WHO licenses to use taxpayer funded health care inventions in developing countries. This would involve more than licenses to orphan patents (diseases without commercial markets). For example, the US government could issue licenses for patents on such highly profitable and high priced AIDS drugs as ddI, d4T, ddI, 3TC, Norvir and fDDa, and provide the WHO with licenses to use data from Taxol clinical trials. f. WTO Working Group on Access to Medicines Public Health Groups have called upon the World Trade Organization to create a working group on access to medicines. This working group would work within the WTO to consider the impact of trade policies on people in developing and least developed countries, and will provide a public health framework for the interpretation of key features of WTO agreements, and evaluate and propose changes in the WTO rules that would expand access to medicines. TACD supports this proposal. g. Production for Export under compulsory license The EU and the USA should send communications to the WTO acknowledging the need to interpret the WTO TRIPS agreement in a way that will permit countries to authorize production for export to countries have issued compulsory licenses for life saving drugs. Most countries in the world do not have sophisticated domestic pharmaceutical industries, and it will be essential for the world trading system to permit exports and imports of drugs that are sold in markets with compulsory licenses. h. No TRIPS plus pressures The US and EU governments should stop putting pressures on developing countries to adopt TRIPS plus levels of intellectual property protection for medicines. A proposal to prevent the US government from requiring TRIPS plus for medicines in Africa has been passed by the US Senate. i. Private actions limit access to essential medicines A number of larger US and European pharmaceutical companies are currently suing in the South African courts to hold up implementation of the South African Medicines Act provisions on fast track compulsory licensing. In Kenya, Medecins Sans Frontieres (MSF) is being threatened with legal action by Pfzier if MSF imports to Kenya inexpensive copies of fluconazole, a drug used to treat HIV/AIDS related cryptococal meningitis, and Bristol-Myers Squibb is fighting a Thailand proposal for a compulsory license to ddI, a US government funded HIV/AIDS drug. AIDS activists are asking governments to take administrative action to pressure large pharmaceutical companies who are currently blocking access to inexpensive medicines in countries that face public health care emergencies. For example, the US and EU governments could decide to withhold contracts or cooperative research agreements from companies to block access to essential medicines in country's with health care emergencies. Countries that regulate prices for pharmaceutical reimbursements could also impose penalties on firms that impede access to essential medicines. -- -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Fri Jan 14 15:55:57 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id A9D3D21B06; Fri, 14 Jan 2000 15:55:57 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id PAA00430; Fri, 14 Jan 2000 15:55:57 -0500 Sender: jamie@genoa.essential.org Message-ID: <387F8D54.C68A0914@cptech.org> Date: Fri, 14 Jan 2000 15:55:48 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Pierre Chirac and Richard Laing exchange regarding WHO EDL The following is an interesting exchange between Pierre Chirac and Professor Richard Laing on the e-drug list, regarding the WHO decision about listing HIV/AIDS drugs on its "Essential Drugs List" (EDL). Pierre Chirac, who is with MSF, argues for an expanded list, and mentioning in particular HIV/AIDS drugs. Professor Laing questions the inclusion of HIV/AIDS drugs on the WHO list. Jamie --------------------------------- Subject: [e-drug] 11th Model List of Essential Drugs (cont'd) Date: Thu, 13 Jan 2000 04:57:39 -0500 (EST) From: Pierre Chirac To: e-drug@usa.healthnet.org E-drug: 11th Model List of Essential Drugs (cont'd) --------------------------------------------- Essential drugs: what about AIDS? The 11th version of the WHO's essential drugs list (published in late december) is already outdated. The concept of essential drugs has been paramount to help countries in selecting drugs according to their efficacy, safety and cost. The idea was that a minimal list of drugs could solve most health problems. Countries were invited to devote most of their limited resources to these drugs. In 1977, when WHO published its first essential drugs list, this was a major step forward. Year after year the list has been revised in a way that: enhanced the number of drugs; enhanced the number of drugs considered as examples of therapeutic groups; enhanced the number of drugs that can be used only in specialized wards (see the long list of anti-cancer drugs for example); enhanced the number of patented drugs (higher priced). WHO considers that "The concept of essential drugs is forward-looking. It incorporates the need to regularly update drug selections to reflect new therapeutic options and hanging unmet therapeutic needs; the need to ensure drug quality; and the need for continued development of better drugs, drugs for emerging diseases, and drugs to meet changing resistance patterns." (quoted from the EDM policy page on WHO web site). Well, so what about AIDS, the first cause of death in Africa? The last revision of the list has included nevirapine for the prevention of mother-to-child transmission. But WHO says that zidovudine and nevirapine are included in the list only for this indication. WHO is so anxious that somebody could use these drugs for adults that this limitation is written in bold character. There is something more about AIDS (also quoted from the EDM page): "treatment of sexually transmitted diseases reduces transmission of the AIDS virus". That's all... What is the problem with AIDS drugs for WHO? "They are beyond the budget of most national drugs programs" (quoted from the 11th list). Well fortunately there is a special UN Agency for AIDS; just visit its web site these days. They have found a solution for AIDS orphans: Swiss citizens sent them toys for Christmas. Of course AIDS is not an easy problem. But WHO will not help in denying its existence. Pierre Chirac MSF - Paris e-mail: pierchir@club-internet.fr -- Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'. Mail administrative requests to `majordomo@usa.healthnet.org'. For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'. <------------------------------------------------------------------------------> Subject: [e-drug] 11th Model List of Essential Drugs (cont'd) Date: Thu, 13 Jan 2000 20:58:11 -0500 (EST) From: Richard Laing To: e-drug@usa.healthnet.org E-drug: 11th Model List of Essential Drugs (cont'd) --------------------------------------------- The question whether Anti-retroviral drugs in their present form should be on the WHO Model list of essential drugs is an issue which depends on an understanding of the term "essential". Firstly this is a model list and any country can decide to add any drug not on the WHO Model list to their countries Essential drug list. It is not a prescriptive list, it is a list which should be a starting point for considering what drugs should be on the national EDL. Also, we should remember that we are basically talking about a public sector drug list. This is not a list for registration. In that case, the criteria for inclusion is based only on safety, quality and efficacy. For an essential drug list additional criteria are needed, and these I would suggest would include ease of use without difficult monitoring systems, relative efficacy in terms of whether these drugs cure or alleviate a condition and some assessment of relative cost. If we look at anti-retrovirals, I think that for many countries the condition of their health systems is such that they would not be able to use these drugs effectively. For example if a country is unable to screen and treat syphilis in pregnancy, then I do not think that country could manage a zidovudine vertical transmission program effectively. In these countries, zidovudine would not be considered as an essential drug. Neverapine has been included on the list on the basis of one study in Uganda in which nearly 80% of eligable participants were excluded. I think that the inclusion of neverapine was premature. We need more evidence. If larger trials show that it is possible to provide routine treatment to pregnant mothers and their children without screening or side effects, and that this treatment is effective in preventing transmission then this drug could be considered to be an essential drug. But I do not think we have enough evidence yet. When we come to anti-retrovirals, we have even less evidence that in the public sector environments that are the venue for the use of these drugs, that they can be used effectively. We have a very good comparison disease, Tuberculosis. This is a disease which can be diagnosed with a simple microscopic slide test of a sputum specimen. It requires daily treatment with four drugs for two months and two drugs for six months. In some environments these drugs are combined into single tablets or combo packs. Minimal monitoring is required, only observation that the individual takes the drugs and a repeat smear at 2 and 6 months. Yet for such an easy disease to cure, many countries cure less than 50% of their patients. If we think of trying to provide multiple different anti-retrovirals, taken at different times during the day, for years without achieving a cure, then I think the practical challenges become clear. Also as I understand it, present practice is to require regular monitoring with CD4 counts and viral load measurements. These are difficult, sophisticated tests that may well be beyond the means of these public health systems to provide. So again, I do not think we have enough evidence that these drugs can be used effectively. We need operational field trials in these environments to assess whether these drugs can be used effectively in terms of delivery, compliance and positive effect. Some countries like Brazil and Thailand which are at a more advanced stage of health system development may be able to use these drugs effectively and so those countries may choose to add these ARV's to the list. There are already drugs on the essential drug list which can be used for prophylaxis which are not being used. Surely these should be the first priority. Nothing in what I have said above should detract from efforts to reduce prices. Some countries will have the capability to use these drugs and every effort should be made to ensure their availability. But I think the WHO Expert committee would have made a mistake to declare anti-retrovirals "essential" on the Model list. These drugs are difficult to use, do not achieve a cure, require sophisticated monitoring and would take resources away from the treatment of diseases such as TB, ARI, STD's and other such conditions that should be addressed first. When better drugs are available or if evidence is provided that the existing drugs can be used empirically without monitoring and with good outcomes, then I would consider them to qualify to be termed "essential". So I would support large scale operational field trials of ARV's to see whether they can be used in this way. Richard Laing Associate Professor of International Health Boston University School of Public Health 715 Albany St, T4W, Boston MA 02118 USA Tel 617 414-1444 Fax 617 638-4476 E-mail richardl@bu.edu -- Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'. Mail administrative requests to `majordomo@usa.healthnet.org'. For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'. <----------------------------------------------------------------------------> Subject: [e-drug] 11th Model List of Essential Drugs (cont'd) Date: Fri, 14 Jan 2000 07:58:44 -0500 (EST) From: Pierre Chirac To: e-drug@usa.healthnet.org E-drug: 11th Model List of Essential Drugs (cont'd) --------------------------------------------- Dear Richard, I am afraid the world has changed... The major arguments of public health experts against putting AIDS at the top of the health agenda are well summarized by Richard in one sentence: "These drugs are difficult to use, do not achieve a cure, require sophisticated monitoring and would take resources away from the treatment of diseases such as TB, ARI, STD's and other such conditions that should be addressed first." I am afraid AIDS is outdating deeply this classic hierarchy of public health priorities. How many people will die from AIDS in 2000? How many in 2005? Choosing between AIDS and other major public health priorities is a mistake. We have no choice than considering AIDS as one of the major public health priorities today and very likely the first one for tomorrow in many countries. Pierre Chirac MSF - Paris pierchir@club-internet.fr -- Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'. Mail administrative requests to `majordomo@usa.healthnet.org'. For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'. From owner-pharm-policy@venice.essential.org Fri Jan 14 16:30:06 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id F37B621B06; Fri, 14 Jan 2000 16:30:05 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id QAA01161; Fri, 14 Jan 2000 16:30:05 -0500 Sender: jamie@genoa.essential.org Message-ID: <387F9553.DC115F9C@cptech.org> Date: Fri, 14 Jan 2000 16:29:55 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Projected World Pharmaceutical Market by Year 2002 Thanks to Richard Laing for this pointer. Jamie -------------- Projected World Pharmaceutical Market by Year 2002 Billions of US Dollars North America $169.5 41.8% EU 100.8 24.8% Japan 45.8 11.3% Latin America and Caribbean 30.5 7.5% SE Asia and China 20.1 5.0% Easter Europe 7.4 1.8% Middle East 10.6 2.6% Africa 5.3 1.3% India Subcontinent 7.3 1.8% Australasia 5.4 1.3% CIS 3.2 0.8% $405.9 100.0% Source: IMS Health http://www.ims-global.com/insight/report/global/report.htm Combined Share of North America, EU and Japan: 78 percent Combined Share of Africa, South East Asia, China, India Latin America and Caribbean 16 percent -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Fri Jan 14 18:36:20 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id D7F3E21B06; Fri, 14 Jan 2000 18:36:19 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id SAA03030; Fri, 14 Jan 2000 18:36:19 -0500 Date: Fri, 14 Jan 2000 18:36:19 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: upd-discuss@venice.essential.org, ip-health@venice.essential.org, pharm-policy@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] Big PhRMA putting gene info in Public Domain Interesting federal register notice regarding big PhRMA's non-profit venture to "carry on scientific research in the public interest, . . . creating a single nucleotide polymorphism (``SNP'') map on the human genome, that will . . . "be placed in the public domain for use by the worldwide medical research community." This is a pretty good illustration of an area where even pharmaceutical companies believe that strong intellectual property rights would harm innovation. Jamie [Federal Register: October 7, 1999 (Volume 64, Number 194)] [Notices] [Page 54645] >From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr07oc99-92] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993--the SNP Consortium Ltd. (``TSC'') Notice is hereby given that, on April 21, 1999, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 et seq. (``the Act''), The SNP Consortium Ltd. (``TSC'') has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing: (1) The identities of the parties; and (2) the nature and objectives of the venture. The notifications were filed for the purpose of invoking the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Pursuant to Section 6(b) of the Act, the identities of the parties are Bayer Corporation, Tarrytown, NY; Bristol-Myers Squibb Company, Princeton, NJ; Glaxo Wellcome Inc., Research Triangle Park, NJ; Hoechst Marion Roussel Inc., Bridgewater, NJ; Hoffmann-La Roche Inc., Nutley, NJ; Monsanto Company, St. Louis, MO; Novartis Pharmaceuticals Corporation, East Hanover, NJ; Pfizer Inc., New York, NY; SmithKline Beecham Corporation, Philadelphia, PA; The Wellcome Trust Limited, as trustee of the Wellcome Trust, London, England; and Zeneca Inc., Wilmington, DE. The nature and objectives of the venture are to carry on scientific research in the public interest, including research intended to advance the field of human medicine by creating a single nucleotide polymorphism (``SNP'') map on the human genome, that will then be made freely available to the public on a nondiscriminatory basis. The joint venture will enable TSC to create a high-density, high-quality SNP map with shared financial risk and without the duplication of effort that would result from the work of individual members. As the SNP map is being constructed, it will be placed in the public domain for use by the worldwide medical research community in identifying specific genes involved in various diseases, thereby facilitating downstream research and development of therapeutic, diagnostic and pharmaceutical products. Constance K. Robinson, Director of Operations, Antitrust Division. [FR Doc. 99-26184 Filed 10-6-99; 8:45 am] BILLING CODE 4410-11-M -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Sat Jan 15 21:05:18 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 3859D21B05; Sat, 15 Jan 2000 21:05:18 -0500 (EST) Received: from cptech.org (ppp-10.essential.org [216.0.125.10]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id VAA14566; Sat, 15 Jan 2000 21:05:15 -0500 Sender: jamie@genoa.essential.org Message-ID: <38812F14.49BBF4DB@cptech.org> Date: Sat, 15 Jan 2000 21:38:12 -0500 From: James Love X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: healthgap , IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Arianna Huffington: Cheap Talk At The United Nations This is Arianna Huffington's recent column on Vice President Gore's speech at the United Nations. Quotes Vice President Al Gore, the State Department, Julie Daivd and me, and mentions MSF, Act Up, the Thailand and Kenya situtation, the drug company's law suit in South Africa, and Susan Finston's move from the Department of State to PhRMA. Jamie http://ariannaonline.com/columns/files/011300.html January 13, 2000 Cheap Talk At The United Nations Arianna Huffington -- James Love, Consumer Project on Technology v. 1.202.387.8030, fax 1.202.234.5176 love@cptech.org, http://www.cptech.org From owner-pharm-policy@venice.essential.org Mon Jan 17 13:42:58 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id AA4EE21B02 for ; Mon, 17 Jan 2000 13:42:53 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id NAA01207; Mon, 17 Jan 2000 13:42:53 -0500 Date: Mon, 17 Jan 2000 13:42:52 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: ip-healh@venice.essential.org, pharm-policy@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] MSF press release on Thai ddI case This is an MSF report from Thailand on the ddI case. Jamie ------------------ THAILAND WILL PRODUCE GENERIC DDI POWDER The Thai Ministry of Public Health today announced that it will not apply compulsory license but that it will let the Government Pharmaceutical Organization (GPO) produce the powder of ddI. About 100 activists had gathered outside the Ministry of Public Health to hear the decision of the Public Health Minister. ddi powder is not patent protected in Thailand. One sachet will cost $0.7 (equivalent to 150 mg); daily cost will therefore be $ 1.4 compared to currently about $ 3.7 No generic tablets will be available because of the patent. The problem with ddI is the expensive raw material because there is only one relatively small supplier in Canada. Raw material from a Japanese producer is only 55% of the cost but this is the BMS supplier and BMS has prevented the company from selling to other customers. If BMS would be interested to actually do something for people they could offer ddI at a daily cost of probably less than $ 1.0! No discount for the BMS product has been announced so far. There are many open questions: As reason for not applying compulsory license the Ministry of Public Health quoted fear for a BMS law suit and lacking support from the Dept of Intellectual Property. The Dept. of Intellectual Property said that they were "worried" to use compulsory license but refused to name reasons. Several activists questioned why compulsory license is in the law if it can not be used. The Public Health Minister was asked why ddI powder was not produced already two years ago; he replied that he was not yet Health Minister at that time. The NGO network had demanded compulsory license for ddI since last year and had also demanded the production of ddI powder as an interim solution. NGO representatives will meet with the US ambassador to Thailand tomorrow, Tuesday to hand over a letter to President Clinton asking for a statement that the US government will not interfere if Thailand uses compulsory license for ddI. Tido von Schoen-Angerer, MD MSF Thailand msfdrugs@asianet.co.th From owner-pharm-policy@venice.essential.org Mon Jan 17 13:46:16 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 2813D21B0B; Mon, 17 Jan 2000 13:46:16 -0500 (EST) Received: from cptech.org (fluid.essential.org [216.0.124.57]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id NAA01263; Mon, 17 Jan 2000 13:46:15 -0500 Sender: tb@genoa.essential.org Message-ID: <388363E9.61C6BA47@cptech.org> Date: Mon, 17 Jan 2000 13:48:09 -0500 From: Thiru Balasubramaniam Organization: Consumer Project on Technology X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: Multiple recipients of list , Multiple recipients of list IP-HEALTH , Multiple recipients of list PHARM-POLICY Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] WHO supports compulsory licensing of expensive drugs http://www.bangkokpost.net/160100/160100_News07.html This article appeared in the Bangkok Post on January 16, 2000. Distributed under Fair-Use. WHO supports compulsory licensing of expensive drugs Local production to benefit HIV patients Aphaluck Bhatiasevi The World Health Organisation has voiced its support for moves to impose compulsory licensing for expensive drugs like didanosine (ddI), which is accessible to less than 10% of Aids victims in the country. Speaking after a meeting with representatives of the Network of People with HIV/Aids, E B Doberstyn, the WHO Representative to Thailand, said his organisation felt that compulsory licensing can be implemented in the interest of the public. "We recognise that compulsory licensing is one of the ways to approach this issue," said Dr Doberstyn, adding that it was legitimate for the government to do so because it complies with the Trade Agreement on Intellectual Property Rights (Trips) as agreed by the World Trade Organisation. He said the WHO will soon issue a statement regarding its stand on this issue, but the decision on whether to enforce compulsory licensing would depend on individual countries. "We will not write to the Ministry of Public Health or the Thai government, but will only issue a paper, stating our stand on the matter," said Dr Doberstyn. Senior ministry officials are still in the process of negotiating with Bristol Myer Squibb, the sole manufacturer and distributor of the anti-retroviral drug ddI, which costs about 47 baht per tablet, a senior health official said yesterday. The official declined to reveal details of the negotiation process, saying that it should be a satisfactory one for both the health officials and the groups demanding compulsory licensing of the drug. But NGOs and Aids activists have insisted that the government should go ahead and enforce compulsory licensing on the drug by using Article 51 of the Intellectual Property Rights Act, which permits state authorities to do so for the benefit of the public. Saree Ongsomwang of the Foundation for Consumers said local production under compulsory licensing would reduce the price of ddI to less than 25 baht per tablet, benefiting a larger number of HIV-positive persons. From owner-pharm-policy@venice.essential.org Mon Jan 17 15:45:04 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 6CEC721B02; Mon, 17 Jan 2000 15:45:04 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id PAA03501; Mon, 17 Jan 2000 15:45:04 -0500 Date: Mon, 17 Jan 2000 15:45:04 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: ip-health@venice.essential.org, pharm-policy@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] Terbes Agreement and Compulsory licensing artice This article was forwarded to the list, and is reposted as a fair use. Forgive my ignorance, but what is the Terbes agreement? ECONOMIC DIALOGUE: Medicine production: a test of intellectual property Dr Abdullah Sadiq Dahlan 12/11/1999 Middle East Newsfile: Saudi Gazette Copyright (C) 1999 Moneyclips Middle East Newsfile; Source: World Reporter (TM) Dr William Henesi, law professor at the Franklin Pearce Law Center, USA, has summarized the various viewpoints expressed during the negotiations that culminated in the final formulation of the Terbes agreement. The following is a restatement of his remarks on the developing countries. At the start of the Uruguay Round, the negotiating team on the agreement was authorized to discuss the commercial aspects of the intellectual property rights within the context of growth and development. This was understood to offer a wide scope of maneuvering for countries from both the industrialized North and the underdeveloped South. The industrialized countries focused their attention, from the beginning, on strengthening the legal framework for the protection of intellectual property rights.The developing nations had, however, a different viewpoint. They believed that the main issue for them was how to get the necessary technology rather than the protection of intellectual property rights. The agreement contained tangible benefits for investors. It stipulated patents for all products and processes in the technological field. The only exception to this general rule were the diagnostic, curative and surgical methods for the treatment of man, animals and plants, excluding the microbes and biological processes used in plant and animal production. Countries that did not have a patent protection system must devise an appropriate and effective law for this purpose. The Terbes agreement stipulated that patent holders can stop others from making products covered by a patent, or from using or selling them. It also empowered them with stopping others from using or selling a patent process, and also from using or selling products obtained through the use of such a process. The agreement guaranteed the right to transfer some patent rights, and allowed signatories to retain certain limitations of patent rights, unless they contravened the ordinary use of a patent by its holder, or undermined his legitimate interests. The restrictions imposed by the agreement on forced licensing are very important to the holder. For one thing, it prohibits countries from granting compulsory licenses unless the patent holder manufactures the patented invention in the concerned country. The agreement allows compulsory licensing only in cases where the patent holder refuses to market his patented products in a certain country, in such cases the license must not lead to exploitation. The restrictions on obligatory licensing aim to encourage voluntary licensing, ensuring that the payment for any obligatory license is fair. The license, thus obtained, cannot be transferred to others except in very few cases, and the licensing rules may be appealed. There are some provisions relating to government use of patents, in cases of national emergency. However, it is possible to grant a obligatory license for a subsequent (second) invention, provided that the second invention is more technologically advanced than the first one, and that the patent holder for the first invention gets a license for the second one. The obligatory license of the second invention can only then be transferred along with the patent. The different viewpoints on the Terbes agreement has led to worldwide controversy. The differing views are held mainly by multinational companies and their subsidiaries in developing countries, on one side, and the national pharmaceutical companies, on the other. The viewpoints of the multinationals were summarized in a document published by the International Federation of Pharmaceutical Association. It says that strengthening intellectual property rights encourages national industries to invest in research and development, and enables a better utilization of national resources, particularly in the innovative development of pharmaceuticals. The bolstering of intellectual rights also leads to a higher quality of locally produced medicines, boosting people's confidence in them. No advance effect on prices is expected as a result of the implementation of the agreement, for most medicines sold in developing countries are generic--they do not have a registered trademark, and are unprotected by a patent. According to this viewpoint, some countries like Egypt have to implement the agreement immediately, without waiting for the end of the transition period. The national pharmaceutical companies, on the other hand, contest the claim that the agreement will help attract foreign investments. They say that strengthening the international protection of intellectual property rights benefits only the advanced countries, even though their economies are affected by the economic activities in the developing countries. If the protection of the intellectual property does any good to developing nations, it is only for their development, such as cost factor, market size, human capital (educational and cultural level), political stability, and the overall economic situation, all of which affects decisions on investing in developing nations. According to estimates from the International Monetary Fund, 40 percent of direct foreign investments in 1993, which amounted to $170 billion, was poured into developing countries. The investment rate is steadily growing. A large portion of the amount was invested in markets where there is no sufficient intellectual property protection. For instance, $20 billion was invested in Mexico in 1993, another $20 billion in southeast Asia, and $27 billion in China. So, attracting investment must have more enticing factors than the protection of intellectual property rights. According to the outcome of a joint questionnaire carried out by the World Bank and US executive directors in 1994, the transfer of advanced technology, such as that used in the pharmaceutical industry, can easily be imitated. The directors expressed their strong belief that the weakness of the protection on intellectual property rights represents a substantial factor in taking decisions pertaining to investments, especially the ones linked to the transfer of advanced technology or setting up developed research centers. However, another study conducted by the UN on the issue yielded a different result. This study, which was not based on a sound scientific experiment, re-affirmed that American companies conduct research and development only in the developing countries in which they invest. They mainly invest in southeast Asia, where they don't give much consideration to the protection of intellectual property. The study stressed that strictness and the application of the protection of intellectual property represents one of the many factors that companies take into account when they decide to invest in a certain developing country. Thus, it is expected that the enforcement of the Terbes agreement will lead to a huge price increase. The expansion in the scope of the protection of the patterns to cover operations and products for a period of no less than 20 years will definitely lead to a price hike and the production of costlier products. Advocates of this trend see that the agreement will make it difficult for developing countries to apply the system of compulsory licensing. In turn, this will add a burden on the health system, which, in turn, will deprive developing countries of benefits from new developments in the health sector. The report pointed out that the abrogation of the compulsory licensing system by Canada will cost it between $4 to $7 billions in the next 15 to 20 years. To be added to this is the rise in the cost of the locally produced medicines which will make them cost-ineffective compared to the international pharmaceutical industries. The viewpoints of those who represented the public, which was not given due attention, can be summarized by the following: The multinational companies exaggerate the research and development cost for two reasons: 1. to erase from the minds of developing countries the idea of investing in this field. 2. to justify the high prices of medicines they produce, they claim that the processing of a new medicine costs at least $400 millions. By any measure, the so-called new developments in the field of medicine do not constitute any major breakthrough in treating many chronic diseases. In the meantime, some studies show that only one-third of the new machines are effective. This makes one support the assumption that patients bear the cost of useless pharmaceutical experiments aimed at manufacturing new drugs. However, it is imperative to carefully examine the claims of the patents' applicants because the scientific achievements are nothing but an accumulation of knowledge and efforts of thousands of scientists in various parts of the world. Nevertheless, this accumulated knowledge can also be derived from the old civilization, in other words, breakthroughs in the field may be based on old knowledge. Consequently, the claims of the patent seekers vis-a-vis their inventions are pure allegations because they must have based their inventions on the knowledge and discoveries of old generations. We can add to this the so-called brain drain or the migration of innovative scientists from the Third World to the advanced countries. However, one can hardly accept the idea of giving a patent to whoever applies, for under these criteria the misuse of this right by the multinational companies will deprive developing countries and poor patients of benefits from some of the scientific achievements which they badly need. It is an indisputable fact that the health sector is a human one, as it transcends borders or sectarian divisions. The harsh rules of the intellectual property rights and the unethical pressures will increase the suffering of the poor elsewhere in the world; this will constitute a burden on the primary healthcare systems in the developing countries. Needless to say, this will lead to a host of socio-economic problems. This confirms the need for transparency in the field of patent rights, especially the one relating to the real cost. From owner-pharm-policy@venice.essential.org Tue Jan 18 02:00:11 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id E91B321B02; Tue, 18 Jan 2000 02:00:10 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id CAA10992; Tue, 18 Jan 2000 02:00:10 -0500 Date: Tue, 18 Jan 2000 02:00:10 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: ip-health@venice.essential.org, pharm-policy@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] Draft statement on early working of pharmacuetical patents I'm sure this could be better. I'm working on several other statements on pharamceutical drug issues. Jamie Draft TACD position paper on Early Working of Pharmaceutical Patents version 1.0 1. Early Working of Pharmaceutical Patents a. Background The United States, Canada and some EU countries provide "early working" exceptions for patent rights, permitting the testing of medicines prior to the expiration of patents in order obtain regulatory approval to market a product. The US early working exception is sometimes referred to as a "Bolar" provision -- a reference to a US Supreme Court decision that prohibited this practice and was later overturned by legislation, as part of the US Hatch/Waxman Act. Some EU governments have early working exceptions as part of more general exceptions for experimental use. The International Federation of Pharmaceutical Manufacturers Associations (IFPMA) and other large research based pharmaceutical industry trade associations have lobbied the US and the EU to eliminate or limit "Bolar" type early working patent exceptions. The US and the EU have both objected to the use of Bolar type provisions in other countries. In Israel, the US government has objected to early working provisions, unless Israel agreed to provide patent extensions for pharmaceutical products. The US has also objected to early working provisions in Cyprus, Argentina, and in several other countries. b. The EU/Canada early working WTO dispute The EU has a WTO complaint (DS 114) against Canada for Canadian provisions for early working of pharmaceutical patents. The Canadian law includes two key provisions. The first is similar to the US Bolar provision, and permits early working of a patent, "solely for uses reasonably related to the development and submission of information required under any law that regulates the manufacture, construction, use or sale of a product (subsection 55.2(1) of the Patent Act)." The second provision provides an exception for a "limited, prescribed period immediately preceding the expiry of the patent," for "the manufacture and storage of articles intended for sale after the patent expires (subsection 55.2(2) of the Patent Act)." Both provisions in the Canadian law are designed to permit rapid introduction of generic drugs into the market following the expiration of pharmaceutical patents. The first provision permits a firm to conduct the tests on a product that will be required by regulators, such as evidence of bioequivalancy. The second provision permits a firm to manufacture and store the product, so that when the patent expires, a generic product can entire the market immediately. The WTO provision for exceptions to patent rights is Article 30 of the TRIPS, which says: Article 30 Exceptions to Rights Conferred Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties. The EU has lodged a complaint with the WTO claiming that the Canadian law early working exception is an unreasonable use of Article 30, and further that it violates Article 27.1 of the WTO's TRIPS accord, which states that, "patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced," on the grounds that the Canadian Act cannot single out pharmaceutical drugs for special treatment. Canada says its early working provisions are reasonable and consistent with the provisions of Article 30 of the TRIPS, and are necessary to prevent the patent owner from unfairly benefiting from a monopoly due to a regulatory system that is designed to protect the public's health: "TRIPS contemplates that Members may, in implementing their obligations within their legal systems, adopt measures which, like those in issue here, introduce limited exceptions to the exclusive rights conferred by a patent and confine the patent monopoly to the specific term for which it is granted, in the interests of promoting full competition in regulated-product markets after the expiry of that term and of realizing the cost-saving benefits that competition in those markets (particularly the health care products market) confers on society. TRIPS does not contemplate that these important societal interests should be overridden by an alleged right of patentees to exploit time-consuming regulatory review systems -- which are neither designed nor intended to protect intellectual property rights -- in order to extend the term of patent protection and to gain a windfall monopoly." With respect to the issue of the WTO and the non-discrimination language in TRIPS Article 27.1, Canada says that the EU is wrong to say that country's cannot have special provisions in patent laws for particular industries: . . . TRIPS does not contemplate that these important societal interests should be overridden by the anti-discrimination requirement of Article 27.1. The latter provision is not intended to require "across the board" derogations from patent rights. That would only defeat Article 30's purpose of permitting exceptions that are "limited", and would compel the application of exceptions where they are not needed. Instead, since Article 27.1 does not purport to define the "patent rights" that it requires to be made available and enjoyable without discrimination, those rights are the ones enumerated in Article 28.1, subject to any exception that may be made under Article 30, 31 or 40. This interpretation gives effect to the language of Article 27.1 in its context rather than in isolation, and achieves the balance contemplated by Article 7 as an objective of the TRIPS Agreement. (See http://www.dfait-maeci.gc.ca/tna-nac/summary-e.asp) The EU complaint is important, because it seeks to restrict the experimental use and production without sale exceptions, and also because it seeks a restrictive interpretation of the non- discrimination language in Article 27.1 of the TRIPS. These are matters of first impression, and the EU's complaint will set important precedents. c. Early working is needed to avoid undue regulatory barriers to entry by generic drugs. The EU is seeking to give pharmaceutical patent owners a significant extension of the effective period of exclusivity, by making it impossible to undertake measures needed to satisfy time consuming regulatory obligations until after patents have expired. This may result in years of delays before generic products can be tested and approved, and will harm consumers through higher prices for pharmaceutical. All WTO member countries, including Canada, are required to provide a minimum of 20 years of patent protection for pharmaceutical drugs. The EU is seeking trade rules that will permit pharmaceutical patent owners to use health and safety regulatory systems as a barrier against competition in the period when patents have expired. d. Article 27.1 should not be interpreted as requiring a "one size fits all" patent law. Also troubling is that contention, by the EU, that Article 27.1 of the TRIPS prohibits countries from having provisions in patent laws that are sector specific. There is no virtue in "one size fits all" patent provisions in national law. The United States has special compulsory licensing provisions for nuclear energy and air pollution control patents, and some EU member countries also have sector specific provisions in patent laws, such as the French provisions regarding compulsory licensing for pharmaceutical drugs. Both the EU and the US have patent extension provisions that apply specifically to pharmaceutical drugs. The new field of biotechnology may benefit from special rules to address specific issues, and there may be merit in special rules for software patents. The drafters of the TRIPS clearly intended to extend patent protection to all fields of technology, specifically including pharmaceuticals, which were excluded from many national patent laws. However, there is no consensus that a "one size fits all" or "lowest common denominator" patent law is in the public interest, and it is our view that this would be an unwise and unreasonable restriction on national sovereignty. e. Precedents for Production for Export. The EU complaint against Canada addresses the question of whether or not Canada can permit production and stockpiling of pharmacueticals prior to the expiration of patents. In our view, such a provision is reasonable and benefits consumers by speeding the introduction of cost saving generic drugs, after patents have expired. However, there is an additional issue that may be affected by a decision in this case. Public health groups are seeking a consensus on the issue of patent exceptions for production for export, where the patent rights in the export market have expired, or are subject to a TRIPS compliant compulsory license. This is a very important issue for access to medicines in developing countries, many of which have small markets and must import drugs. A WTO ruling on the EU/Canada dispute over early working may have an adverse impact on the jurisprudence for the production for export issue. f. US and EU trade policy on early working of patents The United States and the EU should not seek to prevent countries from adopting Bolar style early working provisions in national legislation. The rapid introduction of generic drugs following the expiration of patents is in the public interest. Patent owners have a limited monopoly, and that monopoly should not be extended by regulatory and technical barriers to trade. The expiration of patents is a spur for innovation -- firms have to develop new products. It is not in the public interest to pay high prices of inventions that are more than 20 years old. Investors do not base current investment decisions on expectations of revenues more than 20 years in the future. Changes in regulatory environments have lead to shorter time periods for regulatory approvals -- leading to longer effective patent life. A recent study by CPT of 14 HIV/AIDS drugs found that the average time between the filing of a US patent and the FDA approval of the drug was only 4.4 years. ------------------------------- James Love Center for Study of Responsive Law | Consumer Project on Technology P.O. Box 19367, Washington, DC 20036 | http://www.cptech.org Voice 202/387-8030 | Fax 202/234-5176 | love@cptech.org ------------------------------- James Love Center for Study of Responsive Law | Consumer Project on Technology P.O. Box 19367, Washington, DC 20036 | http://www.cptech.org Voice 202/387-8030 | Fax 202/234-5176 | love@cptech.org From owner-pharm-policy@venice.essential.org Tue Jan 18 07:32:54 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id C983B21B02; Tue, 18 Jan 2000 07:32:54 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id HAA12872; Tue, 18 Jan 2000 07:32:54 -0500 Date: Tue, 18 Jan 2000 07:32:54 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: ip-health@venice.essential.org, pharm-policy@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] Demo outside US Embasssy in Bangkok From msfdrugs@asianet.co.th Tue Jan 18 07:30:33 2000 Date: Tue, 18 Jan 2000 18:09:42 +0700 From: MSF-Drugs Bangkok To: Daniel Berman , Bernard Pecoul , James Love Subject: Demo outside US embassy Dear Daniel, Bernard and Jamie, About 200 people demonstrated outside the US embassy, demanding that the US will not interfere if Thailand uses compulsory license. As in the previous demonstration, people were wearing yellow T-shirts that said (in Thai): "why are medicines so expensive?" and on the back: "I am friend of someone with AIDS". A group of 8 people met with Robert Fitts the economic counselor of the embassy. Fitts said he was waiting for directives from Washington before he could communicate with the Thai government. He said that the US would not object to compulsory license for ddI if it is TRIPS compliant and if it will lower the price and improve access to ddI. [snip] regards, Tido ------------------------------- James Love Center for Study of Responsive Law | Consumer Project on Technology P.O. Box 19367, Washington, DC 20036 | http://www.cptech.org Voice 202/387-8030 | Fax 202/234-5176 | love@cptech.org From owner-pharm-policy@venice.essential.org Tue Jan 18 13:26:32 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id A448421B02; Tue, 18 Jan 2000 13:26:32 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id NAA18907; Tue, 18 Jan 2000 13:26:32 -0500 Sender: jamie@genoa.essential.org Message-ID: <3884B078.AA13E04@cptech.org> Date: Tue, 18 Jan 2000 13:27:04 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] TACD draft position on transparency and economic data This is another draft TACD position paper, this one on transparency and pharmaceutical economics. Jamie Pharmaceuticals Transparency and pharmaceutical economics version 1.0 a. Policy makers need better data about pharmaceutical economics. One of the most vexing issues in pharmaceutical policy making is the paucity of data to justify pharmaceutical industry assertions regarding drug development costs, profit margins or other relevant economic data. Governments have been negligent in collecting independent data on pharmaceutical economics. Accurate data on the economics of the pharmaceutical industry are needed to evaluate a wide range of government policies, including, for example: i. patent extensions, ii. pricing, iii. market exclusivity for health registration data, iv. orphan drug market exclusivity, v. compulsory licensing, vi. government technology transfer policies, and vii. scope of patents. Disclosures of economic data should be routinely required as a condition of market access. b. Drug development costs It is common for discussions regarding pharmaceutical policy to make reference to the high costs of new drug development. However, governments appear to have very little independent data on drug development cost, and that data that does exist raises questions about the accuracy of industry survey data. For example, for the years 1991 to 1994, the US IRS has data from pharmaceutical company tax returns, including data on claimed US R&D expenditures. The Pharmaceutical Research and Manufacturers Association (PhRMA) publishes a widely quoted R&D survey that also purports to identify US R&D expenditures. However, the figures from the IRS are considerably lower than the numbers published by PhrRMA. Table 1 US R&D spending by Pharmaceutical Companies (billions of US dollars) PhRMA IRS Survey Returns 1991 $ 7.9 $4.4 1992 $ 9.3 $5.1 1993 $10.5 $5.9 1994 $11.1 $6.6 Even more surprising are the figures derived from the US tax credit for orphan drug development. This tax credit is equal to 50 percent of the US expenditures on clinical trials. The credit was in effect without suspension from 1983 to 1993. The data are in Table 2. Table 2 US Orphan Drug Tax Credit (millions of US dollars) Pre-Tax Orphan Pre-Tax Expenditures Tax Drug Expenditures per approved Year Credit Approvals on trials drug 1983 $ .2 2 $ .5 $ .2 1984 $ .1 3 $ .2 $ .1 1985 $ .2 6 $ .4 $ .1 1986 $ 6.5 5 $13.1 $2.6 1987 $ 5.2 9 $10.3 $1.1 1988 $ 8.1 8 $16.1 $2.0 1989 $14.2 10 $28.4 $2.8 1990 $15.6 12 $31.3 $2.6 1991 $18.5 12 $37.0 $3.1 1992 $17.8 13 $35.7 $2.7 1993 $20.5 13 $41.0 $3.2 Totals $106.9 93 $213.8 $2.3 Note that the US tax credit for orphan drug development applies to both successful and unsuccessful clinical trials, and is thus adjusted for risk. Also, it is useful to appreciate that during this period, all HIV/AIDS drugs qualified for orphan drug benefits, that drugs for many severe illnesses are classified as orphans, and that orphan drugs are typically very expensive. The data from the US Orphan Drug tax credit provides evidence that private sector contributions to R&D for particular drugs may be far lower than is often asserted by the private sector. c. Government need better data on pricing, sales and margins. There is also limited public information regarding pricing of pharmaceutical products, the revenues or profits from specific drugs, or company margins. Organizations such as IMS provide detailed information on pharmaceutical prices and revenues, but only to selected clients, often excluding government agencies, and with restrictions on the publication of the data. There are many public policy issues that should be grounded in better empirical data. For example, what are the pricing differences for drugs between national markets? How does the expiration of patents influence prices, and what is the "cost" of a patent extension? How much revenue is generated from government funded pharmaceutical inventions? What is the marginal cost of producing life saving HIV/AIDS drugs, in a world where more than 30 million persons cannot afford treatment at current prices? Much of this data is known to the industry, but remains a mystery to public health officials. d. Other disclosure issues. There is a substantial public interest in having more detailed disclosures of private sector R&D investments. For example, what percent of R&D investments are spent on development of new and innovative products, as opposed to "me too" therapies? How much of the private sector R&D budget is spent on non-essential medicines? What is the private sector allocation of spending between pre-clinical development, clinical trials, and post approval R&D? How much R&D is spent on topical illnesses and other diseases that affect the poor? How much did the drug benefit from public subsidies? e. Proposed Actions. The US and the EU governments should undertake the following measures: i). Any application for data exclusivity should include a disclosure of the costs of data collection. ii). The EU and the US should require firms that market pharmaceutical drugs in the US or the EU market to disclose, for each product, A. annual global (and national) revenues, B. costs of clinical trials, disaggregated by timing and nature of trial (Phase I, II, III, IV, etc), the number of patents and the duration of the trial, C. when the product involves licenses from third parties, the royalty payments and terms, and D. the role of the government in the development of the drug, including the awarding of grants, cooperative research and development agreements, licenses, tax credits and other subsidies. iii) Governments should publish data detailing the government's own costs of conducting clinical trials, which can be used as a benchmark. iv). The government should publish reports detailing public expenditures on the purchase of products developed initially with public funds. For example, how much do governments spend to buy such products as d4T, ddI, Novir, Taxol or cisplatin? -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Tue Jan 18 14:54:24 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id D06B321B02; Tue, 18 Jan 2000 14:54:24 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id OAA20918; Tue, 18 Jan 2000 14:54:24 -0500 Sender: jamie@genoa.essential.org Message-ID: <3884C511.71846385@cptech.org> Date: Tue, 18 Jan 2000 14:54:57 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] US government and Industry R&D expenditures compared, 1991 to 1994 I was asked to provide a comparison between pharmacuetical industry and US government health care R&D expenditures. This table looks at the PhRMA/IRS data on pharmaceutical R&D expenditures, and the US Department of Health and Human Services (DHHS) R&D expenditures. This isn't a straight up comparison, however, because the federal government funds R&D through other departments, including the Department of Energy and the Department of Defense, and not all DHHS R&D is compariable (Not all of industry or government R&D is releated to development of new drugs). It is, however, instructive, that even before the recent increases in the NIH budget, the DHHS R&D expenditures were considerably higher than the qualifying R&D expenditures from IRS tax returns. Jamie US R&D spending by Pharmaceutical Companies and US DHHS (billions of US dollars) PhRMA IRS* DHHS** Survey Returns R&D 1991 $ 7.9 $4.4 $ 9.8 1992 $ 9.3 $5.1 $ 9.1 1993 $10.5 $5.9 $10.5 1994 $11.1 $6.6 $10.4 *Form 6765 qualifying expenditures ** NSF's Survey of Federal Funds for Research and Development -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Tue Jan 18 17:59:18 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 7078F21B02; Tue, 18 Jan 2000 17:59:18 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id RAA25198; Tue, 18 Jan 2000 17:59:18 -0500 Sender: jamie@genoa.essential.org Message-ID: <3884F068.1D6F5187@cptech.org> Date: Tue, 18 Jan 2000 17:59:52 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Bill Hennessey article on TRIPS This is an article by William Hennessey that emphasizes the benefits of IPR Protection for economic development. He writes says the "Terbes Agreement" refers to the TRIPS agreement. Jamie ------------------------------------------------------------- Subject: Re: [Ip-health] Terbes Agreement and Compulsory licensing artice Date: Tue, 18 Jan 2000 17:33:30 -0500 From: "Bill Hennessey" To: Dear Mr. Love The article you posted (appended below) is perhaps referring to a paper I delivered at a Symposium sponsored by the World Intellectual Property Organization in Beijing in June, 1999. The writer is referring to the "TRIPs Agreement." My actual comments at that Symposium are attached to this e-mail for the benefit of your readers. [see URL below] The original title of my presentation was "Patent Protection and Its Role in Promoting Invention, Innovation, and Technological Development" (this is the article: http://www.ipmall.fplc.edu/pubs/Pat_Protection_Hennessey_99.htm ) Bill William O. Hennessey Professor of Law Franklin Pierce Law Center 2 White Street Concord NH 03301 USA http://www.ipmall.fplc.edu/ "The Intellectual Property Information Mall" -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 From owner-pharm-policy@venice.essential.org Tue Jan 18 18:47:52 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from gw.gmhc.org (gw.gmhc.org [209.208.140.162]) by venice.essential.org (Postfix) with ESMTP id 2B1EF21B02; Tue, 18 Jan 2000 18:47:52 -0500 (EST) Received: from exchsvr.gmhc.org (exchsvr.gmhc.org [172.16.10.13]) by gw.gmhc.org (8.9.3/8.9.3) with ESMTP id SAA05307; Tue, 18 Jan 2000 18:46:44 -0500 (EST) Received: by exchsvr.gmhc.org with Internet Mail Service (5.5.2650.21) id ; Tue, 18 Jan 2000 18:47:51 -0500 Message-ID: <716C35886498D311AD9A00104BC82DFD25D30D@exchsvr.gmhc.org> From: "Kasper, Toby" To: IP-Health list , pharm-policy Date: Tue, 18 Jan 2000 18:47:50 -0500 MIME-Version: 1.0 X-Mailer: Internet Mail Service (5.5.2650.21) Content-Type: text/plain; charset="iso-8859-1" Subject: [Pharm-policy] RE: [Ip-health] Nafta and parallel imports A week or so ago Jamie posted a request for information about the legality of parallel importing under NAFTA. I forward the query to an expert I knew, and her response is below, which I thought might be of interest to others. Toby Kasper -----Original Message----- From: Judy Rein [SMTP:rein@is4.nyu.edu] Sent: Wednesday, January 12, 2000 10:40 AM To: love@cptech.org Cc: Toby Kasper Subject: NAFTA and parallel imports Hi, Toby forwarded me your question on suing for parallel importing under NAFTA. I assume the question relates to a U.S. citizen seeking to sue the U.S. government for the right to import under NAFTA. My research on this question leads me to say that this is not a viable strategy. NAFTA Chapter 17 covering Intellectual Property is almost identical to the TRIPS agreement. If anything, it is even more biased toward the protection of IP "rights holders" against other users. The best that can be said for it in this regard is that it does not explicitly prohibit parallel imports, but it also does not provide an enforceable right for would-be importers. [Article 1709 (5)(a) on Patents states that "where the subject matter of a patent is a product, the patent shall confer on the patent owner the right to prevent other persons from making, using or selling the subject matter of the patent..." Process patents, on the other hand, are protected from making, using, selling, or IMPORTING. The omission of "importing" with respect to product patents implies that parallel importation of products already in the stream of commerce is not prohibited.] The absence of coverage in this context merely allows for Parties to the agreement (Mex-Canada-U.S.) to establish their own policies with regard to parallel importing. Like TRIPS, countries are allowed to institute higher levels of IP protection, but may not allow protection to fall below the minimum standards established in the Agreement. Parallel importing is viewed by PhRMA and the USTR as an unfortunate loophole in both TRIPS and NAFTA (even as they often have incorrectly stated that it is actually illegal). The Mexican 1992 Industrial Property Law, which reformed pharmaceutical patent protection in compliance with NAFTA, allows parallel importing. So, basically, as I understand it, international agreements leave parallel importing as a problem for domestic law. Have you been following the explosion of on-line pharmacies (essentially parallel exporters)? Most of these are offshore, many in Mexico. I've probably told you more than you want to know, but if you have any other questions, please let me know. I have found your web site extremely useful for my research and congratulate you on the success of your advocacy. Would it be possible for me to get on your e-mail list? Best, Judy Rein jqr7352@is4.nyu.edu -----Original Message----- From: James Love [SMTP:love@cptech.org] Sent: Monday, January 10, 2000 6:28 PM To: IP-Health list; pharm-policy Subject: [Ip-health] Nafta and parallel imports I had a call from someone who wants to sue under NAFTA, for the right to provide parallel imports of pharmaceutical drugs (a potentially profitable business, given the huge differences in prices between the USA and Canada.) He wanted to know if he had a legal basis for doing this, under Nafta. So one else wanted to know if Nafta restricted parallel imports in any way. Do any of the Nafta experts know much about this? Jamie -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 _______________________________________________ Ip-health mailing list Ip-health@lists.essential.org http://lists.essential.org/mailman/listinfo/ip-health From owner-pharm-policy@venice.essential.org Wed Jan 19 13:50:15 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 238B521AFF; Wed, 19 Jan 2000 13:50:15 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id NAA07486; Wed, 19 Jan 2000 13:50:14 -0500 Date: Wed, 19 Jan 2000 13:50:14 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: pharm-policy@venice.essential.org, ip-health@venice.essential.org Cc: healthgap@CritPath.Org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] US Talking Points on Thai ddi CL The USTR just provided us with a copy of the following talking points that were delivered by the US government (USG) to the Thailand government (RGT) on Wednesday, January 19, 2000. The document is one page on plain paper, and has no identifying marks other than what is presented below, so it is of marginal value for showing to other governments -- which is probably intentional by the US government. I was told that the procedure was that the US government official would discuss this with a Thai official, and perhaps, but not necessarily, leave the document with the Thai official. I assume that the document was indeed left with the Thai official. The document doesn't say "don't issue a compulsory license," but it does say, the US government considers compulsory licenses "undesirable because they may undermine intellectual property rights." That's about it for the positive side. On the negative side, the document gives an incomplete and misleading account of the TRIPS provisions, which will likely be read as an effort to discourage the issuance of the license. For example, in the fifth un-numbered talking point, the statement says the TRIPS says that a compulsory license is only permitted "if the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time," a phrase that comes directly from Article 31b of the TRIPS. Omitted from the US government's document is the very next sentence in 31b that reads: "This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use." This a very relevant paragraph because (1) the Thai case involves a public health emergency, and (2) the license is being sought by a government owned pharmaceutical company, for non-commercial public use. To put this into context, consider that in the USA, for example, the government isn't even required to negotiate for patent licenses -- it just takes the patent, subject to compensation. Also, compensation for public use isn't based upon commercial terms (lost profits) in the US, but rather "what the [patent] owner has lost" (Leesona 599 F.2nd at 969). In general, I would have to say that the US government has failed to send a "clear signal" that the Thai government can issue a compulsory license for ddI. Here is the document itself, which as indicated above, is undated, without letterhead or any marks identifying authorship: Jamie Love <---begin Jan 18 USG talking points on Thai license for ddi-----> - We recognize your desire to address all health issues as effectively as possible. This is a goal we fully endorse and support. We believe that your goals can be achieved while promoting adequate and effective intellectual property protection, including patent protection for pharmaceutical products. - We understand that negotiations continue between Thai health officials and a U.S. pharmaceutical manufacturer (Bristol Myer Squibb) over the cost of the anti-HIV drug Videx (often identified by the active ingredient "ddI"). - We also understand the Thai Government is considering issuance of a compulsory license to permit local manufacture of ddI. - We are hopeful that in choosing a course of action in this matter your government will explore all opportunities to obtain the lowest price possible for ddI, including through negotiations with BMS. - The USG has generally viewed compulsory licenses as being undesirable because they may undermine intellectual property rights. However, if the RTG determines a compulsory license is necessary to obtain the lowest price for ddI, the TRIPS Agreement establishes conditions that must be followed. For example, such use may only be permitted if the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time, any license granted must be considered on a case-by-case basis and the government must limit the authority to use that patented invention to acts needed to address the given situation, and predominately to supply the domestic market. - Furthermore, the license must be terminated when the circumstances that give rise to its necessity no longer exist. The patent owner must be paid adequate compensation under the license that takes into account the economic value of the license. The license cannot be transferred to other parties, and must not preclude the ability of the patent owner to make, use, sell or import the patent product. - Finally, the U.S. Department of Health and Human Services would be interested in learning from the RTG its expected outcomes from the use of ddI in the treatment of HIV. ------------------------------- James Love Center for Study of Responsive Law | Consumer Project on Technology P.O. Box 19367, Washington, DC 20036 | http://www.cptech.org Voice 202/387-8030 | Fax 202/234-5176 | love@cptech.org From owner-pharm-policy@venice.essential.org Wed Jan 19 13:15:44 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 245E321B87; Wed, 19 Jan 2000 13:15:29 -0500 (EST) Received: from cptech.org (fluid.essential.org [216.0.124.57]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id NAA06674; Wed, 19 Jan 2000 13:15:29 -0500 Sender: tb@genoa.essential.org Message-ID: <3885FFBE.94863AC2@cptech.org> Date: Wed, 19 Jan 2000 13:17:34 -0500 From: Thiru Balasubramaniam Organization: Consumer Project on Technology X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: Multiple recipients of list IP-HEALTH , Multiple recipients of list PHARM-POLICY Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Dominican Republic IPR legislation Jamie and I met with Claude Burcky (USTR) and Donna DiPaulo (USTR) today. They provided us with a copy of the proposed Dominican Republic law (in Spanish) on industrial property. It is the September 15, 1999 version (so it's not the most recent copy). It's too long to fax (150+ pages). We will try to figure out which are the relevant sections and/or get the USPTO analysis as soon as possible. Thiru Balasubramaniam Consumer Project on Technology From owner-pharm-policy@venice.essential.org Thu Jan 20 13:27:11 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from gw.gmhc.org (gw.gmhc.org [209.208.140.162]) by venice.essential.org (Postfix) with ESMTP id 3CA9521B0C; Thu, 20 Jan 2000 13:27:10 -0500 (EST) Received: from exchsvr.gmhc.org (exchsvr.gmhc.org [172.16.10.13]) by gw.gmhc.org (8.9.3/8.9.3) with ESMTP id NAA14322; Thu, 20 Jan 2000 13:25:51 -0500 (EST) Received: by exchsvr.gmhc.org with Internet Mail Service (5.5.2650.21) id ; Thu, 20 Jan 2000 13:27:07 -0500 Message-ID: <716C35886498D311AD9A00104BC82DFD25D6C3@exchsvr.gmhc.org> From: "Kasper, Toby" To: James Love , IP-Health list , pharm-policy Date: Thu, 20 Jan 2000 13:27:01 -0500 MIME-Version: 1.0 X-Mailer: Internet Mail Service (5.5.2650.21) Content-Type: text/plain; charset="iso-8859-1" Subject: [Pharm-policy] RE: [Ip-health] TACD statement on Access to Medicines in Developi ng Countries Hi Jamie, A few comments on the TACD draft. I'm not sure if your call for comments was intended to start a discussion about this on the email lists - if so, feel free to forward this; otherwise, use as you will privately. First, a quick update: you really don't want to be calling for NIH to make the license for FddA (aka lodenosine) available. Grammatically it's an issue because it's not an FDA-approved drug, so it is not "highly profitable and high price," but far more importantly, US Bioscience, which was developing it, recently stopped all clinical trials of it after a death occurred in a trial, meaning that for all intents and purposes, the chances of it coming to market in the near future are nil. I'm not positive about this, but I think that I recall once hearing that abacavir, a potent nucleoside analog reverse transcriptase inhibitor, was developed with some NIH money, so (if you can confirm my shaky memory) it might make a good substitution. Second, a couple of additional things that might be relevant to ask for, regarding TRIPS and the WTO: * An extension of both the non-violation clause (Article 64.2) and the transition phase (especially Article 65.2 but also Article 66.1) of TRIPS. The former was included in the "Annex: Possible Decisions at Seattle on Implementation" (i.e., items for which there was some significant support but no consensus) of the draft Declaration that was never voted on in Seattle, whereas the latter is something developing countries were pushing for in Seattle but which the US wouldn't give in on (see, for example, the OAU statement of 2 December 1999). Both of these extensions will provide developing countries with the time they need to ensure that their national laws are both TRIPS-compliant and sufficiently flexible to maximize their ability to ensure access to medicine, without the looming threat of trade sanctions and WTO actions (and without a vast dedication of resources needed to fend them off). I think that you have the documents mentioned and so the exact language that has been proposed; let me know if you'd like me to circulate it. An alternative to formal support of an extension of either of these would be a commitment not to pursue Dispute Settlement cases against developing and least developed countries until the Ministerial can be reconvened to discuss the proposals for extension. This is especially relevant in light of the utter failure of developed countries to operationalize the provisions of TRIPS that call for technical support for implementation - which might have allowed developing countries to bring their national laws into TRIPS-compliance - and technology transfer (particularly Articles 67, and 7 and 66.2 , respectively); * A genuine commitment to put into practice the technology transfer provisions of TRIPS, particularly Articles 7 and 66.2. Precious little concrete action has followed from the promises developed countries committed to in the drafting of TRIPS, and until these provisions are operationalized, developing countries are severely hampered in their abilities to genuinely develop indigenous capacity to research and produce medicine relevant to local need. Worse still, the US has sought to limit the ability of developing countries to impose technology transfer requirements on companies that seek to invest in their markets by amending the TRIMS (Trade-Related Investment Measures) Agreement to specifically prohibit such requirements (see the WTO document WT/GC/W/115). You've probably seen it, but if not, I recommend Carlos Correa's excellent paper, "Review of the TRIPS Agreement: Fostering the Transfer of Technology to Developing Countries," which goes into much greater depth on the subject of technology transfer. Take care, Toby -----Original Message----- From: James Love [SMTP:love@cptech.org] Sent: Friday, January 14, 2000 2:21 PM To: IP-Health list; pharm-policy Subject: [Ip-health] TACD statement on Access to Medicines in Developing Countries This is a first draft of a TACD statement on Access to Medicines in Developing Countries. Suggestions are welcome. TACD will be meeting in Washington, DC on Feb 10, 2000. (See http://www.tacd.org for background on TACD). Jamie Love version 1.0 Pharmaceuticals 1. Access to Medicines in developing countries. a. Developing countries are facing a crisis in access to essential medicines. Large disparities in incomes have contributed to a crisis in terms of access to essential medicines in developing countries. Consider the following: - 1.3 billion people in the world live on less than US$1 per day 20% of the world's population consumes 80% of the world's resources - Every 3 seconds a child dies of diseases of poverty - 17 million deaths per year are due to infectious disease - Currently 33 million people live with HIV, 7-8 million with active TB - More than 90% of all death and suffering from infectious diseases occurs in the developing world - 20% of the world's population uses 80% of the world-wide production of medicines - 0.2% of pharmaceutical research is devoted to acute respiratory infections, TB, diarrhoea, while 18% of deaths are attributable to these diseases. b. Trade disputes involving health care are common. Since 1997, South Africa has been attempting to implement legislation to provide fast track mechanisms for compulsory licensing and parallel importing of essential medicines. South Africa is engulfed in a tragic health care crisis, with an estimated 20 percent of its young adults testing positive for HIV/AIDS. During the past three years, the US government, the European Commission, and officials from the United Kingdom, Germany and France have pressured South Africa to modify or repeal sections of its Medicines Act that would facilitate fast track compulsory licensing and parallel importing of essential medicines. There have been similar pressures on Thailand, a country with 1 million HIV/AIDS patients, and many other poor countries. The Dominican Republic, which faces a growing HIV/AIDS problem and an under funded public health effort, is currently being pressured over proposed fast tract compulsory licensing legislation. India is being pressured over proposals for fast tract compulsory licensing. The Philippines, Mexico, Thailand, South Africa, Indonesia and other countries have been pressured over proposals to promote the use of generic names in prescriptions and package labeling. There are also trade disputes over price controls, early working of patents, research exemptions, scope of patents, the timing of adherence to new WTO rules regarding intellectual property, the period of exclusivity for health registration data and many other issues. c. Public Health Considerations should be paramount in trade policies as they relate to access to medicines. The US and EU governments should review trade policies to ensure that developing countries do not face trade related barriers for access to essential medicines and other medical technologies. This is consistent with the World Health Assembly's endorsement EB103/4, which called upon member countries: (1) to reaffirm their commitment of developing, implementing and monitoring national drug policies and to taking all necessary concrete measures in order to ensure equitable access to essential drugs; (2) to ensure that public health interests are paramount in pharmaceutical and health policies; and (3) to explore and review their options under relevant international agreements, including trade agreements, to safeguard access to essential drugs; On December 1, 1999, the United State government announced a new initiative to incorporate public health considerations into trade policy, and to modify its trade policy in order to ensure broader access to medicines for HIV/AIDS and other illnesses. The EU and its member countries should do the same. d. R&D on neglected diseases. Today there is very little research and development on diseases such as malaria, chagas disease and other illnesses that primarily impact the poor. The US, the EU and other developed countries should enter into an agreement to support far higher levels of R&D on these diseases. Moreover, these R&D efforts should be designed with access in mind, and address issues such as reasonable pricing and the allocation of intellectual property rights. e. Access to publicly supported R&D Public health groups have called upon the US and the EU and its member countries to enter into agreements with the World Health Organization (WHO) to give the WHO licenses to use taxpayer funded health care inventions in developing countries. This would involve more than licenses to orphan patents (diseases without commercial markets). For example, the US government could issue licenses for patents on such highly profitable and high priced AIDS drugs as ddI, d4T, ddI, 3TC, Norvir and fDDa, and provide the WHO with licenses to use data from Taxol clinical trials. f. WTO Working Group on Access to Medicines Public Health Groups have called upon the World Trade Organization to create a working group on access to medicines. This working group would work within the WTO to consider the impact of trade policies on people in developing and least developed countries, and will provide a public health framework for the interpretation of key features of WTO agreements, and evaluate and propose changes in the WTO rules that would expand access to medicines. TACD supports this proposal. g. Production for Export under compulsory license The EU and the USA should send communications to the WTO acknowledging the need to interpret the WTO TRIPS agreement in a way that will permit countries to authorize production for export to countries have issued compulsory licenses for life saving drugs. Most countries in the world do not have sophisticated domestic pharmaceutical industries, and it will be essential for the world trading system to permit exports and imports of drugs that are sold in markets with compulsory licenses. h. No TRIPS plus pressures The US and EU governments should stop putting pressures on developing countries to adopt TRIPS plus levels of intellectual property protection for medicines. A proposal to prevent the US government from requiring TRIPS plus for medicines in Africa has been passed by the US Senate. i. Private actions limit access to essential medicines A number of larger US and European pharmaceutical companies are currently suing in the South African courts to hold up implementation of the South African Medicines Act provisions on fast track compulsory licensing. In Kenya, Medecins Sans Frontieres (MSF) is being threatened with legal action by Pfzier if MSF imports to Kenya inexpensive copies of fluconazole, a drug used to treat HIV/AIDS related cryptococal meningitis, and Bristol-Myers Squibb is fighting a Thailand proposal for a compulsory license to ddI, a US government funded HIV/AIDS drug. AIDS activists are asking governments to take administrative action to pressure large pharmaceutical companies who are currently blocking access to inexpensive medicines in countries that face public health care emergencies. For example, the US and EU governments could decide to withhold contracts or cooperative research agreements from companies to block access to essential medicines in country's with health care emergencies. Countries that regulate prices for pharmaceutical reimbursements could also impose penalties on firms that impede access to essential medicines. -- -- James Love http://www.cptech.org mailto:love@cptech.org voice 1.202.387.8030 _______________________________________________ Ip-health mailing list Ip-health@lists.essential.org http://lists.essential.org/mailman/listinfo/ip-health From owner-pharm-policy@venice.essential.org Fri Jan 21 05:05:03 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id C036E21BC7; Fri, 21 Jan 2000 05:05:03 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id FAA06724; Fri, 21 Jan 2000 05:05:03 -0500 Date: Fri, 21 Jan 2000 05:05:03 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: ip-health@venice.essential.org, pharm-policy@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] Transparency and Government Contracts In part because we are unhappy that it is so difficult to get basic information from NIH and other agencies regarding licensing terms for government owned patents, we are asking President Clinton to put these and other contracts on the Internet (as they do for the ICANN contracts now). We will probably follow up with similiar requests to WHO, WTO, and other international bodies. Jamie ------------------------------- URL for letter: http://www.cptech.org/ecom/contracts-jan6.html URL for Palmedo McCarthy notes http://www.cptech.org/ecom/may1999.txt Ralph Nader P.O. Box 19312, Washington, DC 20036 James Love Consumer Project on Technology P.O. Box 19367, Washington, DC 20036 http://www.cptech.org January 6, 2000 President William Clinton The White House 1600 Pennsylvania Ave. Washington, D.C. 20500 Dear Mr. President, We are writing to ask that you issue an Executive Order setting procedures for every agency of the federal government to place its contracts on the Internet. We believe this initiative will help fundamentally change the accountability of government agencies to the public, and greatly reduce the number of poorly conceived contractual agreements now issued by federal agencies. We are in an era when private firms spend public funds for a wide range of activities, and there are daily transfers of public property to the private sector for a variety of purposes and rationales. The development of the Internet has created a new opportunity to empower scholars and the interested public to review and evaluate this growing and profoundly important aspect of government and budget allocations. In referring to contracts, we are speaking broadly about a wide range of written agreements, including such items as leases for mineral rights from public lands, research grants, industry government cooperative agreements, joint ventures with industry for the development of energy efficient cars, contracts for prison services, contracts with the independent counsel, consulting contracts, agreements to dispose of nuclear wastes, concession agreements for national parks, contracts for logging on public lands, licenses to government owned patents on biotechnology inventions such as the so called terminator seed patent, licenses to use public spectrum for broadcasting and telecommunications services, agreements with firms that do security clearances for federal agencies, debt collection contracts with private collection agencies, bank bailouts, loans and loan guarantee agreements, and countless other agreements. At present there are wide disparities among federal agencies with respect to access to government contracts. To its credit, the US Department of Commerce has placed existing and proposed contracts with the Internet Corporation for Names and Numbers (ICANN) on the Internet for public inspection and comment. However, most agencies make it difficult or impossible to obtain copies of government contracts. There is no public depository library that catalogs these documents for historical purposes. For example, the National Institutes of Health (NIH) enters into hundreds of agreements giving private firms and Universities exclusive rights to use patent and other rights from billions of dollars in federal research. The NIH refuses to disclose these contracts except under freedom of information Act (FOIA) requests, and even then only after long delays and typically with extensive redactions, including, for example, NIH's suppression of the amount of money or royalty rates private firms agree to pay in return for commercial rights worth millions or even billions of dollars. Mike Palmedo and Shawn McCarthy recently investigated the availability of government contracts to the public. They attempted to obtain 81 federal contracts that were listed in the Washington Post on May 10, 17 or 24, 1999, by contacting both the businesses and the government agencies that signed the contracts. We are attaching their notes. In no cases were they able to obtain copies of contracts from the businesses, and none of the federal agencies voluntarily provided copies of the contracts. The only mechanism available to Palmedo and McCarthy would have been to file requests under FOIA, a process that would be very time consuming, particularly when compared to making contracts directly available on the Internet, and in too many cases unsuccessful. In a period when your Administration is highlighting the brave new information age and the Internet and is focusing on ways that e-commerce can make transactions faster and more efficient, it is long overdue for you to harness this technology to make government accountability work in Internet time. After we receive your reply, we would like to meet with officials from your Administration to discuss this proposal further. Sincerely, Ralph Nader James Love cc: Palmedo and McCarthy notes on access to government contracts. -- James Love, Consumer Project on Technology v. 1.202.387.8030, fax 1.202.234.5176 love@cptech.org, http://www.cptech.org From owner-pharm-policy@venice.essential.org Fri Jan 21 05:07:56 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id A285C21BCA; Fri, 21 Jan 2000 05:07:56 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id FAA06746; Fri, 21 Jan 2000 05:07:56 -0500 Date: Fri, 21 Jan 2000 05:07:56 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: pharm-policy@venice.essential.org, ip-health@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=ISO-8859-1 Content-Transfer-Encoding: QUOTED-PRINTABLE Subject: [Pharm-policy] New argument in favor of Bolar-Roche provision forward from Jerome Dumoulin. Jamie ------------------ From=20Jerome.Dumoulin@upmf-grenoble.fr Fri Jan 21 05:05:58 2000 Date: Fri, 21 Jan 2000 10:57:36 +0100 From: J=E9r=F4me Dumoulin To: love@cptech.org Subject: New argument in favor of Bolar-Roche provision Jamie, I have just read a new article in Health Economics (Jorge Mestre Ferrandiz, The Impact of Generic Goods in the Pharmaceutical Industry, Health Economics 8: 599-612 1999) which fuels a argument in favor of Bolar-Roche provision, This is a new argument I think. The author studied firm strategies about launching branded generics. It is the same on the generics market as on many markets, the first mover has an advantage to take market shares, so the innovative firm has a great advantage to produce the generic itself. Without Bolar Roche provision, the pionner firm can easily be the first mover on the generic market (because they can prepare marketing generic drugs several years before potential competitors) and can take a great advantage on potential competitors. So in many case, the only generic will be a branded generic marketed by the brand drug pionner firm. This firm will lock in the market with its two products : the branded product and the generic product. The result will be no actual competition. "The firm uses the generic as a means to increase the price of its branded good in order to obtain higher profits. Furthermore, this firm can charge a higher price for the generic good compared with the price that would otherwise be set by a third firm not producing producing the generic alternative." (snip) "The policy implications of these results are that, since the promotion of generic drugs is coming from different sides of the economy, from a social point of view, their entry should be encouraged through firms not producing their own branded good, but rather through firms who specialise in the productyion of generics. Hence, entry barriers to these firms should be made as low as possible." Bolar Roche provision is not only a mean to bring generics on the market as soon as possible, as it is usually argued, but it is a mean to make generic competition sustainable, preventing patent owner to monopolise the generic drugs market. We can suppose pharma companies are so strongly opposed to Bolar-Roche provision because they know this mecanism. Yours Jerome J=E9r=F4me Dumoulin Institut de Recherche Economique sur la Production et le D=E9veloppement Universit=E9 Pierre Mend=E8s-France BP 47 F 38040 Grenoble Cedex 9 tel : 33-(0)4 76 82 54 50 fax : 33-(0)4 76 82 59 89 jerome.dumoulin@upmf-grenoble.fr=20 From owner-pharm-policy@venice.essential.org Fri Jan 21 10:14:19 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from smtp10.atl.mindspring.net (smtp10.atl.mindspring.net [207.69.200.246]) by venice.essential.org (Postfix) with ESMTP id D723521B1E; Fri, 21 Jan 2000 10:14:18 -0500 (EST) Received: from [165.247.45.4] (user-2iveb84.dialup.mindspring.com [165.247.45.4]) by smtp10.atl.mindspring.net (8.9.3/8.8.5) with ESMTP id KAA09931; Fri, 21 Jan 2000 10:14:16 -0500 (EST) Message-Id: <200001211514.KAA09931@smtp10.atl.mindspring.net> X-Mailer: Microsoft Outlook Express Macintosh Edition - 4.5 (0410) Date: Fri, 21 Jan 2000 10:13:37 -0500 From: "Eric Sawyer" To: James Love , pharm-policy@venice.essential.org, ip-health@venice.essential.org Mime-version: 1.0 X-Priority: 3 Content-type: text/plain; charset="US-ASCII" Content-transfer-encoding: 7bit Subject: [Pharm-policy] Re: [Ip-health] New argument in favor of Bolar-Roche provision ---------- >From: James Love >To: pharm-policy@venice.essential.org, ip-health@venice.essential.org >Subject: [Ip-health] New argument in favor of Bolar-Roche provision >Date: Fri, Jan 21, 2000, 5:07 AM > > Jamie and et al. > > Gaelle said that you had sent a copy of the US government letter to > Thailand but I did not get it was something sent? > > French activist groups and other countries want to target US Embasseys on > not giving Thialand an additional license for DDI I think we should too, > > French Government in Meetings with ACT UP PAris said they support > Compulsory licensing and want to organize meetings with other governmenet > to increase activities to improve access to treatments. > > Any news or do you have the US letter? If it was a negative letter we > should support demonstrations everywhere as this would represent a step > backwards.Eric Sawyer From owner-pharm-policy@venice.essential.org Fri Jan 21 17:03:44 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from gw.gmhc.org (gw.gmhc.org [209.208.140.162]) by venice.essential.org (Postfix) with ESMTP id E85D021B1E; Fri, 21 Jan 2000 17:03:43 -0500 (EST) Received: from exchsvr.gmhc.org (exchsvr.gmhc.org [172.16.10.13]) by gw.gmhc.org (8.9.3/8.9.3) with ESMTP id RAA21052; Fri, 21 Jan 2000 17:02:16 -0500 (EST) Received: by exchsvr.gmhc.org with Internet Mail Service (5.5.2650.21) id ; Fri, 21 Jan 2000 17:03:39 -0500 Message-ID: <716C35886498D311AD9A00104BC82DFD25DA27@exchsvr.gmhc.org> From: "Kasper, Toby" To: James Love , pharm-policy@venice.essential.org, ip-health@venice.essential.org Date: Fri, 21 Jan 2000 17:03:33 -0500 MIME-Version: 1.0 X-Mailer: Internet Mail Service (5.5.2650.21) Content-Type: text/plain; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Subject: [Pharm-policy] RE: [Ip-health] New argument in favor of Bolar-Roche provision Although I don't think that there's any dispute that Bolar-Roche = provisions facilitate generic competition, I'm not so convinced that the fear of = losing a monopoly on generic provisions is a major reason that the research pharmaceutical industry opposes Bolar provisions (and hence another = reason for those of us interested in increasing access to medicines to support them). After all, if the first generic manufacturer to enter the = market after patent expiry was guaranteed high profits, and research pharmaceuticals were assured of being the first in the absence of a = Bolar provision, then wouldn't one expect the lion's share of generics in the = EU (were Bolar provisions are absent) to be produced by the same companies = that held the licenses? This is obviously not the case. See for example, = this excerpt from "How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry" by the US = Congressional Budget Office: "Most generic subsidiaries [of brand-name firms] do not produce copies of their parent company's drugs. Out of 112 multiple-source = drugs in the retail pharmacy data set, only 13 had a generic subsidiary of the brand-name manufacturer selling more than 10 percent of the = prescriptions dispensed through retail pharmacies. In general, the incentives to = lower price in order to gain market share are the same for all generic manufacturers, whether or not they are the subsidiary of an innovator = firm. But an important exception occurs when the generic subsidiary produces = a copy of the parent company's innovator drug. Though infrequent, in such cases the subsidiary may have less incentive to lower price than other generic producers because it does not want to take more sales away from = the parent company's drug. And when the generic subsidiary does lower price dramatically, the innovator firm suffers." (http://www.cbo.gov/showdoc.cfm?index=3D655&sequence=3D4) So far as I understand the economic theory here, the reasoning for this = is pretty straightforward: because there is much less "brand-loyalty" to generics and price competition tends to be intense among near-identical products, first entry to the market is no guarantee of market control. Thus, there is little risk of monopolization of a generic market, by = the company that holds the patent or anyone else. Obviously, this is not a reason to oppose Bolar provisions, as they are still crucial for bringing cheaper versions to market quickly (although NERA's study of generics in the OECD estimated that the lag between = expiry of patents and entry to market of a generic in the absence of a Bolar provision was six months to two years, and sometimes considerably less; "Policy relating to generic medicines in the OECD countries: Final = report prepared for the European Commission DG III"; downloadable from http://www.nera.com/practice/healthpraf.html) . However, it is not a guarantee of affordable pricing for generics: the studies quoted in the = CBO study mentioned above all indicate that price is highly sensitive to = the number of market players, declining significantly as more generic = products are introduced. Best, Toby Kasper Gay Men's Health Crisis New York, NY USA tobyk@gmhc.org -----Original Message----- From: James Love [SMTP:love@cptech.org] Sent: Friday, January 21, 2000 5:08 AM To: pharm-policy@venice.essential.org; ip-health@venice.essential.org Subject: [Ip-health] New argument in favor of Bolar-Roche provision forward from Jerome Dumoulin. Jamie ------------------ From Jerome.Dumoulin@upmf-grenoble.fr Fri Jan 21 05:05:58 2000 Date: Fri, 21 Jan 2000 10:57:36 +0100 From: J=E9r=F4me Dumoulin To: love@cptech.org Subject: New argument in favor of Bolar-Roche provision Jamie, I have just read a new article in Health Economics (Jorge Mestre Ferrandiz, The Impact of Generic Goods in the Pharmaceutical Industry, Health Economics 8: 599-612 1999) which fuels a argument in favor of Bolar-Roche provision, This is a new argument I think. The author studied firm strategies about launching branded generics. It is the same on the generics market as on many markets, the first mover has an advantage to take market shares, so the innovative firm has a great advantage to produce the generic itself. Without Bolar Roche provision, the pionner firm can easily be the first mover on the generic market (because they can prepare marketing generic drugs several years before potential competitors) and can take a great advantage on potential competitors. So in many case, the only generic will be a branded generic marketed by the brand drug pionner firm. This firm will lock in the market with its two products : the branded product and the generic product. The result will be no actual competition. "The firm uses the generic as a means to increase the price of its branded good in order to obtain higher profits. Furthermore, this firm can charge a higher price for the generic good compared with the price that would otherwise be set by a third firm not producing producing the generic alternative." (snip) "The policy implications of these results are that, since the promotion of generic drugs is coming from different sides of the economy, from a social point of view, their entry should be encouraged through firms not producing their own branded good, but rather through firms who specialise in the productyion of generics. Hence, entry barriers to these firms should be made as low as possible." Bolar Roche provision is not only a mean to bring generics on the market as soon as possible, as it is usually argued, but it is a mean to make generic competition sustainable, preventing patent owner to monopolise the generic drugs market. We can suppose pharma companies are so strongly opposed to Bolar-Roche provision because they know this mecanism. Yours Jerome J=E9r=F4me Dumoulin Institut de Recherche Economique sur la Production et le D=E9veloppement Universit=E9 Pierre Mend=E8s-France BP 47 F 38040 Grenoble Cedex 9 tel : 33-(0)4 76 82 54 50 fax : 33-(0)4 76 82 59 89 jerome.dumoulin@upmf-grenoble.fr=20 _______________________________________________ Ip-health mailing list Ip-health@lists.essential.org http://lists.essential.org/mailman/listinfo/ip-health From owner-pharm-policy@venice.essential.org Fri Jan 21 18:23:28 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id A90A021B1E; Fri, 21 Jan 2000 18:23:28 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id SAA18149; Fri, 21 Jan 2000 18:23:28 -0500 Sender: jamie@genoa.essential.org Message-ID: <3888EA13.52265F21@cptech.org> Date: Fri, 21 Jan 2000 18:21:55 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=iso-8859-1 Content-Transfer-Encoding: 8bit Subject: [Pharm-policy] US Government Use of Patents and Reasonable Royalty Rates I ran across this... jamie http://home.att.net/~rjmcgrath/AIPLA2.HTM THE UNAUTHORIZED USE OF PATENTS BY THE UNITED STATES GOVERNMENT OR ITS CONTRACTORS Richard J. McGrath* V. Filing Suit In The United States Claims Court B. Just Compensation In The United States Claims Court 2. Reasonable Royalty Rates Since the usual measure of damages in a 28 U.S.C. § 1498 action is a reasonable royalty,(50)a patent owner can estimate the value of a claim or lawsuit. Historically, the highest royalty rate that the United States Claims Court has awarded is 10%.(51) In the Tektronix case, plaintiff asserted a substantial portfolio of patents, and the patents were recognized as pioneer inventions that had a major impact in their industry.(52) Unless there is evidence of a higher established royalty rate, it is unlikely that the United States Claims Court will award more than a 10% royalty. If there is an established royalty rate or comparative royalty rate(53) the Court is likely to use that rate. As a general rule the Claims Court is likely to find approximately a 6% royalty rate, unless one of the parties offers sufficient evidence to support either a higher or lower established royalty rate.(54) If there is no established royalty rate for the patent in suit, the 6% royalty rate is probably the best rate to use for evaluating a claim. The patent owner should multiply the 6% royalty rate or established royalty rate, if one exists, by the amount of the allegedly infringing procurement to determine an estimated amount of recovery. In other words, if there has been $10,000,000 worth of allegedly infringing procurement and there is no established royalty rate, the estimated recovery would probably be 6% x $10,000,000 or $600,000. -------Notes----------------- 50. The criteria for determining reasonable royalties are set forth in Georgia-Pacific Corp. v. U.S. Plywood Corp., 318 F.Supp. 1116, 1120 (S.D.N.Y. 1970); 446 F.2d 295 (2d Cir. 1971); cert. denied, 92 S.Ct. 105 (Oct. 12, 1971). 51. Tektronix, Inc. v. United States, 552 F.2d 343, 351 (Ct. Cl. 1977). 52. Id. at p. 345. 53. Carley Life Boat Co. v. United States, 74 Cl. Ct. 682 (Ct. Cl. 1932); Calhoun v. United States, 453 F.2d at 1293. 54. The royalty rates in the Claims Court tend to vary from 2%, Pitcairn v. United States, 547 F.2d 1106, 1119 (Ct. Cl. 1976), to 10%, Tektronix v. United States, 552 F.2d at 351, with 6% being typical. The determination of typical royalty rates are set forth in Jamesway v. United States, 207 U.S.P.Q. 131, 144 (Ct. Cl. 1980) (6-1/2% royalty rate); Dynamics Corp. of America v. United States, 5 Cl. Ct. 591, 609 (Cl. Ct. 1984), (6% royalty rate). -- James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | mailto:love@cptech.org Voice 1.202.387.8030 | fax 1.202.387.8030 From owner-pharm-policy@venice.essential.org Fri Jan 21 21:27:57 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id B5C6821B1B; Fri, 21 Jan 2000 21:27:57 -0500 (EST) Received: from cptech.org (ppp-7.essential.org [216.0.125.7]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id VAA19795; Fri, 21 Jan 2000 21:27:56 -0500 Sender: jamie@genoa.essential.org Message-ID: <38891D5F.66E1ED35@cptech.org> Date: Fri, 21 Jan 2000 22:00:47 -0500 From: James Love X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] David Banta in JAMA http://jama.ama-assn.org/issues/v283n3/full/jmn0119-2.html Vol 283, No. 3 January 19, 2000 Increase in Global Access to Essential Drugs Sought David Banta, MD, MPH -- James Love, Consumer Project on Technology v. 1.202.387.8030, fax 1.202.234.5176 love@cptech.org, http://www.cptech.org From owner-pharm-policy@venice.essential.org Sat Jan 22 11:57:31 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 5F6C121B05; Sat, 22 Jan 2000 11:57:31 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id LAA24883; Sat, 22 Jan 2000 11:57:31 -0500 Date: Sat, 22 Jan 2000 11:57:31 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: pharm-policy@venice.essential.org, ip-health@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] Thai ddI / letter to Rosshirt This is what I send to Thomas Rosshirt, the Vice President's National Security spokesperson, on the Thai/ddI case. Jamie James Love Consumer Project on Technology P.O. Box 19367 Washington, DC 20036 January 22, 2000 Thomas M. Rosshirt National Security Spokeperson for the Vice President The White House Washington, DC 20500 Dear Tom: I am writing to express my astonishment regarding the US government January 18 communication with the Government of Thailand in the dispute over the issuance of a compulsory license for patents held by Bristol-Myers Squibb for the manufacturing of ddI, an important HIV/AIDS drugs. This is the way it seems to me: 1. On June 25, 1999, in a letter to the US Congressional Black Caucus, the Vice President signals a change in US policy during on the issue of compulsory licensing of HIV/AIDS drugs in devoting countries. 2. November 25, 1999, an official from the Thailand Ministry of Health tells hundreds of public health groups in a meeting in Amsterdam that its government will not issue a compulsory license for ddI or other HIV/AIDS drugs, due to US trade pressures. 3. On December 1, 1999, in the middle of huge protests at the WTO, President Clinton announces that US trade policy will no longer be a barrier to access to essential medicines. 4. On January 10, 2000, the Vice President appears at the UN Security Council to discuss the global HIV/AIDS crisis, and mentions the change in US trade policy. The Vice President receives enormous positive press coverage for this announcement. 5. On January 12, 2000, Act Up, Doctors Without Borders, the Consumer Project on Technology, Public Citizen and other NGOs meet with USTR, US PTO, and DHHS to discuss public health trade disputes. Doctors without Borders (aka MSF) and all of the other NGOS ask USTR to send a clear signal to Thailand that the US government has changed its trade policy, and that Thailand will face no pressure from the US government if it issues a compulsory license for ddI. USTR is told that the NGO groups want the US government to send the Thai government a letter outlining the new policy, and they also ask for a copy of the letter, which they say they will use in other country disputes as evidence that US policy has changed. NGOs leave the meeting believing the US government will do this. The ddI case is considered a very clear cut case. ddI was invented on a government grant, and the US government obtained the patent for using ddI on HIV/AIDS. In Thailand Bristol-Myers Squibb is using two process or formation patents to block generic production, including one that includes claims already rejected by the US Patent and Trade Mark Office. Thailand has the infrastructure to treat HIV/AIDS patents and about one in 60 Thailand citizens are HIV positive. There have been Thailand protests for the ddI compulsory license since fall of 1998. 6. On January 16, 2000, the Thai government announces it has rejected the ddI compulsory license, telling protesters that the rejection is based upon US trade pressures. 7. On January 18, 2000, the US government presents the Thai government with an undated, untitled and unsigned letter, on plain paper. The document includes 7 unnumbered talking points. According to the document, "The USG has generally viewed compulsory licenses as being undesirable because they may undermine intellectual property rights." Nowhere in the document does the US government ever say it would support a Thai decision to issue a compulsory license for ddI. The talking points also say that if the Thai government still wants to issue a compulsory license, it must comply with several WTO TRIPS conditions. The US government letter then goes on to quote only those sections of Article 31 of the TRIPS that emphasize patent owner rights, and omits the sections of Article 31 that emphasize user or government rights. For example, there is not mention at all of the provisions in Article 31 for government or non-commercial public use, even though the Thai compulsory license is for a public sector agency. In my opinion, the January 18, 2000 communication to the Thai government does not represent any change in US policy, and it difficult to see how it can be read as anything other than continued trade pressure against the Thai on the ddI license. If the US government wants to send a clear signal to the Thai regarding the ddI compulsory license, it can surly do so. If it wants to send a clear signal to the whole world, it can clearly do so. That fact that this not happening is causing me to wonder if President Clinton and Vice President Gore are being straight with the American public regarding US foreign policy. I would like to hear from the Administration as to what official US policy is on the issue of the Thai government issuing a compulsory license for ddI, and I would like this on official US government letterhead, with someone's name attached. Thank you. Sincerely, James Love Director Consumer Project on Technology James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | love@cptech.org Voice 202/387-8030 | Fax 202/234-5176 From owner-pharm-policy@venice.essential.org Sat Jan 22 21:07:14 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 9773521B28; Sat, 22 Jan 2000 21:07:14 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id VAA30031; Sat, 22 Jan 2000 21:07:14 -0500 Date: Sat, 22 Jan 2000 21:07:14 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: ip-health@venice.essential.org, pharm-policy@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] Rosshirt letter - date fixed This is a corrected version of the Rosshirt letter. The date of USG/Thai talking points was January 19, 2000, not January 18, 2000. This and a few typos were fixed. http://www.cptech.org/ip/health/thailand/tmr-jan22-2000.html -- James Love Consumer Project on Technology P.O. Box 19367, Washington, DC 20036 January 22, 2000 Thomas M. Rosshirt Foreign Policy Spokeman for the Vice President The White House Washington, DC 20500 Dear Tom: I am writing to express my astonishment regarding the US government January 19 communication with the Government of Thailand in the dispute over the issuance of a compulsory license for patents held by Bristol-Myers Squibb for the manufacturing of ddI, an important HIV/AIDS drugs. This is the way it seems to me: 1.On June 25, 1999, in a letter to the US Congressional Black Caucus, the Vice President signals a change in US policy during on the issue of compulsory licensing of HIV/AIDS drugs in devoting countries. 2.November 25, 1999, an official from the Thailand Ministry of Health tells hundreds of public health groups in a meeting in Amsterdam that its government will not issue a compulsory license for ddI or other HIV/AIDS drugs, due to US trade pressures. 3.On December 1, 1999, in the middle of huge protests at the WTO, President Clinton announces that US trade policy will no longer be a barrier to access to essential medicines. 4.On January 10, 2000, the Vice President appears at the UN Security Council to discuss the global HIV/AIDS crisis, and mentions the change in US trade policy. The Vice President receives enormous positive press coverage for this announcement. 5.On January 12, 2000, Act Up, Doctors Without Borders, the Consumer Project on Technology, Public Citizen and other NGOs meet with USTR, US PTO, and DHHS to discuss public health trade disputes. Doctors without Borders (aka MSF) and all of the other NGOS ask USTR to send a clear signal to Thailand that the US government has changed its trade policy, and that Thailand will face no pressure from the US government if it issues a compulsory license for ddI. USTR is told that the NGO groups want the US government to send the Thai government a letter outlining the new policy, and they also ask for a copy of the letter, which they say they will use in other country disputes as evidence that US policy has changed. NGOs leave the meeting believing the US government will do this. The ddI case is considered a very clear cut case. ddI was invented on a government grant, and the US government obtained the patent for using ddI on HIV/AIDS. In Thailand Bristol-Myers Squibb is using two process or formation patents to block generic production, including one that includes claims already rejected by the US Patent and Trademark Office. Thailand has the infrastructure to treat HIV/AIDS patents and about one in 60 Thailand citizens are HIV positive. There have been Thailand protests for the ddI compulsory license since fall of 1998. 6.On January 17, 2000, the Thai government announces it has rejected the ddI compulsory license, telling protesters that the rejection is based upon US trade pressures. 7.On January 19, 2000, the US government presents the Thai government with an undated, untitled and unsigned letter, on plain paper. The document includes 7 unnumbered talking points. According to the document, "The USG has generally viewed compulsory licenses as being undesirable because they may undermine intellectual property rights." Nowhere in the document does the US government ever say it would support a Thai decision to issue a compulsory license for ddI. The talking points also say that if the Thai government still wants to issue a compulsory license, it must comply with several WTO TRIPS conditions. The US government letter then goes on to quote only those sections of Article 31 of the TRIPS that emphasize patent owner rights, and omits the sections of Article 31 that emphasize user or government rights. For example, there is not mention at all of the provisions in Article 31 for government or non-commercial public use, even though the Thai compulsory license is for a public sector agency. In my opinion, the January 19, 2000 communication to the Thai government does not represent any change in US policy, and it difficult to see how it can be read as anything other than continued trade pressure against the Thai on the ddI license. If the US government wants to send a clear signal to the Thai regarding the ddI compulsory license, it can surely do so. If it wants to send a clear signal to the whole world, it can clearly do so. That fact that this not happening is causing me to wonder if President Clinton and Vice President Gore are being straight with the American public regarding US foreign policy. I would like to hear from the Administration as to what official US policy is on the issue of the Thai government issuing a compulsory license for ddI, and I would like this on official US government letterhead, with someone's name attached. Thank you. Sincerely, James Love Director Consumer Project on Technology For more information on this topic, see: http://www.cptech.org/ip/health -- James Love, Consumer Project on Technology v. 1.202.387.8030, fax 1.202.234.5176 love@cptech.org, http://www.cptech.org From owner-pharm-policy@venice.essential.org Mon Jan 24 09:16:29 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 2DEBA21B02 for ; Mon, 24 Jan 2000 09:16:29 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id JAA12956 for ; Mon, 24 Jan 2000 09:16:29 -0500 Sender: jamie@genoa.essential.org Message-ID: <388C5E7B.AF2EB09C@cptech.org> Date: Mon, 24 Jan 2000 09:15:23 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] TACD: draft Health Registration Data Exclusivity statement This is a draft, not an official TACD document. Comments are welcome: Jamie Love TACD on Pharmaceutical Registration Data Exclusivity version 1.0 1. Background There is controversy over the period of data exclusivity as it relates to the pharmaceutical regulatory process. The issue concerns the status of various tests and medical research that are submitted in order to gain marketing approval for pharmaceutical drugs. In the absence of data exclusivity, generic drugs or drugs produced under a compulsory license can be introduced into the market on the basis of simple bioequivalence tests, without having to replicate time consuming and expensive clinical trials that are used to establish the efficacy and safety of the products. In the United States, for the first five years, only the "owner" of data is permitted to rely upon the evidence of safety and efficacy used for marketing approval of a product. In the EU, the period of data exclusivity is 10 years for EU registrations, or 6 to 10 years for national registrations. Outside the US and EU there are a wide range of approaches to this issue, including many countries where there are no rules regarding data exclusivity. The US provisions on data exclusivity are part of a broader compromise on issues relating to the introduction of generic drugs, early working of patents and patent extensions for pharmaceuticals. In the EU, the 10 year period of EU registrations was initially designed to compensate for a lack of pharmaceutical patent protection in Spain and Portugal, as the EU permits parallel imports of pharmacueticals within the EU. This situation has been changed with the adoption of the WTO/TRIPS agreement, which requires patent protection for pharmaceutical drugs. 2. The economic rationale for data exclusivity The putative rationale for periods of data exclusivity is to provide an economic incentive for research. However, governments have other economic incentives for investments in research. If a company is responsible for an invention, it will receive a patent, giving the firm exclusive rights for 20 years or more. Firms may also receive exclusive marketing rights under the US or EU orphan drug laws. In the US the orphan drug act provides seven years of marketing exclusivity. The EU orphan drug legislation will provide for 10 years of marketing exclusivity. Thus, in cases where the firm has an invention or when the product is for a relatively small number of patients, the EU and the US already provide for substantial periods of marketing exclusivity. Thus, the primary importance of the data exclusivity provisions in US and EU law are to provide marketing exclusivity in cases where the firm is not the inventor and the market is large. The data exclusivity provisions are part of a growing class of sui generis forms of protection that are designed to protect investment, rather than innovation. Because data exclusivity isn't a reward for invention (which is already rewarded by patents) but rather a protection of investment, there should be greater transparency of the basis for the protection and a reasonable relationship between the investment and the protection. 3. The Taxol/Paclitaxel case Critics of the current system say US and EU provisions on data exclusivity are excessive. One example is the case of Taxol, the Bristol-Myers Squibb (BMS) version of Paclitaxel, a drug used to treat breast, ovarian and lung cancer, Kaposi sarcoma and other illnesses. Paclitaxel was discovered and initially developed by the US NIH. Government scientists began a program to screen 35,000 plant species for anticancer activity in 1958. By 1963, extracts of the Pacific Yew tree were examined, and found to have antileukemic and antitumor activity. In 1971, paclitaxel was identified as an active ingredient, and became the subject of further NIH funded research. In 1983, the US government began a series of human use clinical trials using paclitaxel. By 1988 the US government documented paclitaxel's antitumor activity for ovarian cancer. The government subsequently sponsored clinical trials for many types of cancer. By 1990 Paclitaxel had entered Phase III clinical trials for ovarian cancer, the last stage before FDA approval. It was not until 1991 that the US government signed a contract with BMS. The contract gave the company the worldwide exclusive rights to use US government sponsored research data in regulatory proceedings. In 1992 BMS asked for and received US FDA marketing approval for Taxol. BMS's contribution to the development of Taxol was minor. The company's only role in the initial development period was to assume responsibility for the production of the drug, and this obligation began less than two years before FDA approval. BMS used the government's own contractor to manufacture Paclitaxel. BMS did not sponsor any of the clinical trials used for Taxol approval. BMS paid no royalties for obtaining the exclusive rights to Taxol. Despite signing a reasonable pricing clause with the NIH, BMS announced a wholesale price that was about 20 times its costs of bulk production. Taxol was an immediate commercial success. In the several years that Taxol has been on the market, it has generated billions of dollars for BMS, including about $1.5 billion last year alone. Taxol is currently being use for the treatment of ovarian, breast and non-small cell lung cancer, and Kaposi Sarcoma. There was no patent for the discovery of Paclitaxel itself or its antitumor activity against cancer. But the health registration data exclusivity provisions in US and EU law created a barrier to entry. Generic companies could not introduce products that relied upon the NIH sponsored clinical trials, and had to create their own clinical trials. There were also other barriers to entry. BMS used the US orphan drug act to prevent US generic firms from obtaining FDA approval for Kaposi Sarcoma. BMS also obtained the rights to NIH patents on certain methods of administering paclitaxel (doses), which it has used as the basis for expensive patent litigation against would be entrants. BMS also purchased a Dutch firm that had conducted its own EU Paclitaxel trials, and engaged in other efforts to discourage entry. In 1997, BMS lobbied the US Congress to extend the US period of data exclusivity from 5 to 10 years. To gain support for the proposal, BMS offered to pay a 3 percent royalty to NIH, and promised to reinvest another 3 percent of its revenues in research. Critics of the proposal said the longer period of data exclusivity would harm consumers, who were already paying high prices for a drug that was initially developed by the government. The legislative proposals failed, but BMS was able to block US introduction of a generic product for 30 months, by claiming the generic product would infringe upon patents covering the methods of administering Paclitaxel. 4. The Consequences of the Taxol monopoly. In the 1997 US debate over Taxol, economist Richard P. Rozek estimated that a two year delay in the introduction of generic versions of Paclitaxel would cost US consumers $1.27 billion. (Costs to the U.S. Health Care System of Extending Marketing Exclusivity for Taxol, N.E.R.A., Washington, DC, March 1997). As noted, BMS charges about 20 times its costs of bulk production for Taxol. The product is so expensive that its use is restricted under formularies in the US and in Europe. In the UK access to Taxol is a subject of controversy and national debate. 5. WTO rules regarding protection of undisclosed information. BMS has asked the US government to object to generic Paclitaxel registrations in several countries, including the Netherlands, the EU, Australia, South Africa, Argentina, New Zealand and Turkey. These objections are typically framed in terms of WTO/TRIPS provisions regarding undisclosed information. Article 39.3 of the TRIPS says that governments, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. The IFPMA, PhRMA and other large pharmaceutical companies are asking that this provision be interpreted to require 10 years of data exclusivity. In some cases, the US government has sought data exclusivity periods internationally that are longer than the 5 years that are required by US law. Article 39.3 asks that "undisclosed test or other data" that involves "considerable effort" be protected from unfair commercial use, but it doesn't say how this should be done. The US government has an aggressive interpretation of Article 39.3, arguing in several countries that it requires every country to protect the data disclosed by any government. Moreover, the US has argued it even violates the TRIPS for countries to rely upon US FDA actions as evidence of safety and efficacy. The text of Article 39.3 appears to be narrower, and this will likely be addressed by the WTO later. It is the view of TACD that the Article 39.3 of the TRIPS should not be interpreted to require unreasonable barriers to the introduction of generic drugs. Since research that is inventive is already rewarded by patent, and products with small markets are protected by orphan drug marketing exclusivity, the important cases are those where the products have large markets and for which the company was not the inventor. In many cases, these are products, like Taxol, that have benefited by government funded research. If the purpose of the TRIPS is to protect "considerable effort," the amount of protection should be reasonably related to the costs of the data collection. Governments should avoid the abuses of the Taxol case, where there was no relationship between the period of data exclusivity, the company's investment in the development of the drug, and the profitability of the Taxol monopoly. Article 39.3 protections should be based upon financial disclosures. Moreover, a system of cost sharing or compulsory licensing of the data rights should be included to protect the public from excessive exclusivity provisions, to avoid situations such as the Taxol case. <---------------------------------------------------------------> Appendix A WTO/TRIPS Provisions SECTION 7: PROTECTION OF UNDISCLOSED INFORMATION Article 39 1. In the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention (1967), Members shall protect undisclosed information in accordance with paragraph 2 and data submitted to governments or governmental agencies in accordance with paragraph 3. 2. Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices (See footnote 10) so long as such information: (a) is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question; (b) has commercial value because it is secret; and (c) has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret. 3. Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use. Footnote: 10 For the purpose of this provision, "a manner contrary to honest commercial practices" shall mean at least practices such as breach of contract, breach of confidence and inducement to breach, and includes the acquisition of undisclosed information by third parties who knew, or were grossly negligent in failing to know, that such practices were involved in the acquisition. <------------------------------------------------------------> Appendix B 1999 Berlin Communique, TABD http://www.tabd.org/recomb/berlincomm.html] PHARMACEUTICALS: Data Exclusivity The pharmaceutical industry supports a harmonised EU-US approach on data exclusivity to ensure access to medicines and stimulate innovation, but recognises that views within the industry vary. The generic sector supports a harmonised US and EU approach for the protection of safety and efficacy data. It recommends a period of up to five years for new chemical entities only. The generic sector is also concerned that the introduction of data exclusivity laws in countries joining the EU will have negative effects on the local industries in those countries and therefore calls for transitional provisions in this area. The innovative sector is united in supporting a harmonised US and EU 10-year period of data exclusivity for NCE's as well as for additional safety and efficacy data, as this would bring economics and patient benefit by stimulating the further and efficient development of medicines. It is also crucial to ensure that countries seeking to join the EU as new members equalise data exclusivity for pharmaceutical products that were marketed before the change in their laws. <-------------------------------------------------------------> Appendix C TABD Mid Year Report May 10, 1999 Washington, D.C. Technical Annex http://www.tabd.org/about/MYMTechnicalAnnex.html PHARMACEUTICALS: Data Exclusivity Recommendation: The U.S. and the EU currently provide different periods of protection for the safety and efficacy data that companies generate at great expense to support the approval of new products by regulatory authorities. Within the EU, the protected period varies with 10 years provided for products approved under the centralized EU procedure and 6 of 10 years for all other products. In the U.S., the protection afforded varies with 5 years granted for new chemical entities and 3 years for new indications. Countries seeking to join the EU as new members, in addition to providing strong patent protection, should offer data exclusivity for new products as well as for products that were on the market at the time of accession. Industry?s 1998 recommendations were to seek a harmonized protection period within the EU and to harmonize the U.S. and EU periods of data protection (exclusivity) to ten years. Moreover, countries seeking to join the EU should equalize data protection for pharmaceutical products that were marketed before the change in their laws. Action Taken and State of Play: At the 1998 TABD Conference, both U.S. and EU authorities recognized the concern over lack of transatlantic harmonization with respect to the period of data protection. The Commission has also recognized the need to provide data protection for pharmaceutical products, and has expressed sympathy for a full and complete harmonization up to a 10-year period within the EU. However, neither side has taken any affirmative action in this regard. Outlook/New Issues: It appears unlikely that U.S. legislation will be introduced in the near future. There will be an opportunity to propose organization through legislation within the EU in the year 2000. As an independent intellectual property right (separate from other protections such as patents) industry is concerned that any new Member States in the CEE accession fully implement EU law regarding this right as part of their obligation to adhere to Community law. Because the Member States differ in the periods of data exclusivity they offer harmonization of ten years? should be accomplished prior to accession of new Member States. <-------------------------------------------------------------> Appendix D 21 U.S.C. Sec. 355(c)(3)(D)(ii) (ii) If an application submitted under subsection (b) of this section for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b) of this section, is approved after September 24, 1984, no application which refers to the drug for which the subsection (b) application was submitted and for which the investigations described in clause (A) of subsection (b)(1) of this section and relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted may be submitted under subsection (b) of this section before the expiration of five years from the date of the approval of the application under subsection (b) of this section, except that such an application may be submitted under subsection (b) of this section after the expiration of four years from the date of the approval of the subsection (b) application if it contains a certification of patent invalidity or noninfringement described in clause (iv) of subsection (b)(2)(A) of this section. The approval of such an application shall be made effective in accordance with this paragraph except that, if an action for patent infringement is commenced during the one-year period beginning forty-eight months after the date of the approval of the subsection (b) application, the thirty-month period referred to in subparagraph (C) shall be extended by such amount of time (if any) which is required for seven and one-half years to have elapsed from the date of approval of the subsection (b) application. <-----------------------------------------------------------> Attachment E Excerpt from MSF, Health Action International, Consumer Project on Technology An open letter to the WTO Member States November 8, 1999 http://www.msf.org/advocacy/accessmed/wto/reports/1999/letter/ 5) Avoid restrictive and anti-competitive interpretations of country obligations under Article 39 of the TRIPS, concerning health registration data. Article 39 of the TRIPS is a little debated and little understood provision that requires WTO members to protect health registration data from disclosure or unfair commercial use. Some have argued that if a country requires the use of scientific data to register a pharmaceutical product for sale, the TRIPS requires countries to provide some level of exclusivity for that data, including restrictions on the ability to rely upon the data to register a competing product. In bilateral trade actions, the US government has argued that countries are obligated by the TRIPS to prevent generic drug companies from even relying upon published scientific papers or foreign government regulatory approvals, without permission from the "owners" of the data that the papers or approvals were based upon. In the absence of data exclusivity, generic drugs or drugs produced under a compulsory license can be introduced into the market on the basis of simple bioequivalence tests, without having to replicate time consuming and expensive clinical trials that are used to establish the efficacy and safety of the products. But if countries are required by the WTO to adopt excessive protection for data exclusivity, there will be problems with providing marketing authorization for generic products and drugs produced under a compulsory license using existing registration data. At present, several countries, including the US and the members of the EU, provide several years of data exclusivity, for purposes of regulatory approval of pharmaceuticals. There are proposals from public health groups to replace current US and EU rules on data exclusivity with new rules that curb abuses such as the Taxol (Paclitaxel) case III . Some proposals would include requirements that companies make public disclosures of the actual costs of clinical trials and other data they seek to protect from "unfair commercial use," and that protections be reasonably related to the actual investment costs. The actual impact of Article 39 on competition and access to drugs is quite unclear, because the language in the Article is not precise regarding country obligations. The WTO interpretations of country obligations will be critical. There is a need to examine the empirical evidence and economic analysis used to support various national policies regarding exclusive rights to health registration data, as well as the historical justification given for such policies. The WHO should provide the WTO with a report on the least trade restrictive policies with regard to protection of such data, and accept public comment on anti-competitive aspects of current national regimes, including the 10 year period used in the European Union, that was initially introduced to compensate for the lack of patent protection in Spain and Portugal. By providing the WTO with a communication on the need to avoid excessive and anti-competitive levels of data exclusivity, countries can help set a pro-public health agenda on this issue. -- James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | mailto:love@cptech.org Voice 1.202.387.8030 | fax 1.202.387.8030 From owner-pharm-policy@venice.essential.org Tue Jan 25 10:55:12 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id B019D21B1A; Tue, 25 Jan 2000 10:55:12 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id KAA03382; Tue, 25 Jan 2000 10:55:12 -0500 Date: Tue, 25 Jan 2000 10:55:12 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: pharm-policy@venice.essential.org, tacd-pharmaceutical@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] Canada to win early working - but lose on stockpiling It appears as though the WTO will approve the so called "Bolar" early working exceptions for Canada, that relate to the test of products prior to patent expiration, but that Canada will likely lose on the stockpiling issue. Jamie Report on Business: Canadian WTO upholds patent rules for generic drugs SHAWN McCARTHY 01/25/2000 The Globe and Mail Metro Page B2 Ottawa -- The World Trade Organization has upheld Canadian patent rules that allow manufacturers of generic pharmaceuticals to develop and get approvals for copies of brand-name drugs that are under patent protection, sources say. The trade body rejected a European challenge to Canadian rules. A loss by Canada on the so-called early-working provisions would have delayed by several years the introduction of lower-cost copies of brand-name drugs due to come off patent. The WTO interim ruling has not been released publicly, but sources said Canada won on the key early-working issue. They said, however, that the trade body ruled against Canada on a provision that allows generic firms to stockpile copycat products in anticipation of patent expiry. The Europeans will have the opportunity to make further arguments to the WTO panel before a final ruling, which is expected to be released in late February. [snip] James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | love@cptech.org Voice 202/387-8030 | Fax 202/234-5176 From owner-pharm-policy@venice.essential.org Tue Jan 25 11:13:32 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id EF59521B05 for ; Tue, 25 Jan 2000 11:13:31 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id LAA03721 for ; Tue, 25 Jan 2000 11:13:31 -0500 Date: Tue, 25 Jan 2000 11:13:31 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: pharm-policy@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] (no subject) Another issue in the Canada case is the EU contention that the Canada Bolar exception violates the TRIPS Article 27.1 antidiscrimination rules for patents. If Canada is permitted to provide early working for pharmacueticals, then the WTO seems to be rendering a decision that Article 27.1 requires that while all fields of technology be covered by patents, countries can adopt differential rules to for fields of technology, to address social objectives, so long as those differences are consistent with the TRIPS. This, of course, is just my guess, and I would appreciate comments on this important issue. I haven't seen the EU pleading in this case. We have seen a few documents from the Canada side, such as the items they put on the web. (Why doesn the EU put its briefs on the web, so its own citiznes can find out what their foreign policy is?) Jamie ------------------- James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | love@cptech.org Voice 202/387-8030 | Fax 202/234-5176 From owner-pharm-policy@venice.essential.org Tue Jan 25 11:14:33 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 370B921B12 for ; Tue, 25 Jan 2000 11:14:33 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id LAA03735 for ; Tue, 25 Jan 2000 11:14:33 -0500 Date: Tue, 25 Jan 2000 11:14:33 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: pharm-policy@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] Canada decision and 27.1 issue Same, but with subject line ----- Another issue in the Canada case is the EU contention that the Canada Bolar exception violates the TRIPS Article 27.1 antidiscrimination rules for patents. If Canada is permitted to provide early working for pharmacueticals, then the WTO seems to be rendering a decision that Article 27.1 requires that while all fields of technology be covered by patents, countries can adopt differential rules to for fields of technology, to address social objectives, so long as those differences are consistent with the TRIPS. This, of course, is just my guess, and I would appreciate comments on this important issue. I haven't seen the EU pleading in this case. We have seen a few documents from the Canada side, such as the items they put on the web. (Why doesn the EU put its briefs on the web, so its own citiznes can find out what their foreign policy is?) Jamie ------------------- James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | love@cptech.org Voice 202/387-8030 | Fax 202/234-5176 From owner-pharm-policy@venice.essential.org Tue Jan 25 11:56:44 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 34C5D21B05 for ; Tue, 25 Jan 2000 11:56:44 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id LAA04561 for ; Tue, 25 Jan 2000 11:56:44 -0500 Date: Tue, 25 Jan 2000 11:56:43 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: pharm-policy@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] US pressure in Dominican Republic Patent dispute I received this note today from a person in the Dominican Republic, regarding US pressure the patent dispute. [snip] The U.S. Embassy in the Dominican Republic has a campaign going on to try to modify the proposal of the goverment for a new intelectual property Law. This proposal was approved by the Senate on November and it is pending of aproval by the House of Representatives. As you may imagine the proposal contains provisions that will assure the dominican patients acces to new drugs (cumpolsory licenses, Exhaust of Rigths, etc.) and this has trigger the critics of the Embassy. They have bring to the country so called experts on I.P. to question the proposed law, Doris Long, a professor from John Marshall School of Chicago, prepare a document to descredit the law. They use a foundation named Alexis de Tocquerville to elaborate another document in the same direction. The Embassy has make it clear to the Dominican Republic that the benefits derivating from the Caribbean Basin Initiative (C.B.I.) and the S.G. P. and, more important than this, the Law that will give this country and others of the region the Parity with Mexico for the treatment of exports to the U.S. of textiles manufacturies will be lost if the proposed law is approved without modifications. well I'll be in touch for details [snip] James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | love@cptech.org Voice 202/387-8030 | Fax 202/234-5176 From owner-pharm-policy@venice.essential.org Tue Jan 25 12:21:12 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 56ABD21B05 for ; Tue, 25 Jan 2000 12:21:12 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id MAA04984 for ; Tue, 25 Jan 2000 12:21:12 -0500 Date: Tue, 25 Jan 2000 12:21:12 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: pharm-policy@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] Query to USTR on DR dispute I have asked USTR for some information on the DR dispute. In particular, I am looking for details on the linkage of textile exports and access to medicines. This "jobs for drugs" linkage came up in South Africa with respect to a steel dumping dispute, and in Thailand, with repect to exports of wood products and jewerly to the US. I think US citizens should be able to find out from our own government, what our foreign policy is. Jamie ---------------------- >From love@cptech.org Tue Jan 25 12:15:10 2000 Date: Tue, 25 Jan 2000 12:06:42 -0500 (EST) From: James Love To: "Papovich, Joseph" Subject: [Pharm-policy] US pressure in Dominican Republic Patent dispute (fwd) Joe, we would like some details of the US position in the Dominican Republic case. As you can see, our foreign policy is pretty active, and foreigners know what our policy is. Can ordinary US citizens find out what is going on? For example, what "linkage" is going on between access to drugs and exports of textiles? Jamie ---------- Forwarded message ---------- Date: Tue, 25 Jan 2000 11:56:43 -0500 (EST) From: James Love To: pharm-policy@venice.essential.org Subject: [Pharm-policy] US pressure in Dominican Republic Patent dispute I received this note today from a person in the Dominican Republic, regarding US pressure the patent dispute. [snip] The U.S. Embassy in the Dominican Republic has a campaign going on to try to modify the proposal of the goverment for a new intelectual property Law. This proposal was approved by the Senate on November and it is pending of aproval by the House of Representatives. As you may imagine the proposal contains provisions that will assure the dominican patients acces to new drugs (cumpolsory licenses, Exhaust of Rigths, etc.) and this has trigger the critics of the Embassy. They have bring to the country so called experts on I.P. to question the proposed law, Doris Long, a professor from John Marshall School of Chicago, prepare a document to descredit the law. They use a foundation named Alexis de Tocquerville to elaborate another document in the same direction. The Embassy has make it clear to the Dominican Republic that the benefits derivating from the Caribbean Basin Initiative (C.B.I.) and the S.G. P. and, more important than this, the Law that will give this country and others of the region the Parity with Mexico for the treatment of exports to the U.S. of textiles manufacturies will be lost if the proposed law is approved without modifications. well I'll be in touch for details [snip] James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | love@cptech.org Voice 202/387-8030 | Fax 202/234-5176 From owner-pharm-policy@venice.essential.org Tue Jan 25 14:17:45 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 665F221AFF for ; Tue, 25 Jan 2000 14:17:45 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id OAA07423 for ; Tue, 25 Jan 2000 14:17:45 -0500 Date: Tue, 25 Jan 2000 14:17:45 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: pharm-policy@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] Martin Frid on Alexis de Tocqueville Institution >From mjfrid@hotmail.com Tue Jan 25 14:16:14 2000 Date: Tue, 25 Jan 2000 19:39:49 +0100 From: Martin Frid To: James Love Subject: Re: [Ip-health] US Pressure on Dominican Republic Patent law Dear Jamie, The Alexis de Tocqueville Institution is a right-wing think thank in Arlington, Va. They have a web site with a lot of articles and stuff about IP and South America in particular. http://www.adti.net Jack Kemp, the republican vice-president nominee in 1996 is co-chairman togheter with Gregory Fossedal (who said in a Voice of America interview April 1, 1999 that "the Cold War was a great policy, and a victory for humanity"). The ADTI was named as one of five up-and-coming think tanks by The National Journal. Martin ----- Original Message ----- From: James Love To: Cc: Sent: Tuesday, January 25, 2000 5:55 PM Subject: [Ip-health] US Pressure on Dominican Republic Patent law > > I received this note today from a person in the Dominican > Republic, regarding US pressure the patent dispute. > > [snip] > > The U.S. Embassy in the Dominican Republic has a campaign going on to > try to modify the proposal of the goverment for a new intelectual > property Law. This proposal was approved by the Senate on November and > it is pending of aproval by the House of Representatives. > > As you may imagine the proposal contains provisions that will assure the > dominican patients acces to new drugs (cumpolsory licenses, Exhaust of > Rigths, etc.) and this has trigger the critics of the Embassy. They have > bring to the country so called experts on I.P. to question the proposed law, > Doris Long, a professor from John Marshall School of Chicago, prepare a > document to descredit the law. They use a foundation named Alexis de > Tocquerville to elaborate another document in the same direction. > > The Embassy has make it clear to the Dominican Republic that the benefits > derivating from the Caribbean Basin Initiative (C.B.I.) and the S.G. P. and, > more important than this, the Law that will give this country and others of > the region the Parity with Mexico for the treatment of exports to the U.S. > of textiles manufacturies will be lost if the proposed law is approved > without modifications. > > well I'll be in touch for details > > [snip] > > > James Love, Consumer Project on Technology > P.O. Box 19367 | http://www.cptech.org > Washington, DC 20036 | love@cptech.org > Voice 202/387-8030 | Fax 202/234-5176 > > > > _______________________________________________ > Ip-health mailing list > Ip-health@lists.essential.org > http://lists.essential.org/mailman/listinfo/ip-health > _______________________________________________ Ip-health mailing list Ip-health@lists.essential.org http://lists.essential.org/mailman/listinfo/ip-health From owner-pharm-policy@venice.essential.org Tue Jan 25 16:37:35 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 04BBA21AFF for ; Tue, 25 Jan 2000 16:37:35 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id QAA10392 for ; Tue, 25 Jan 2000 16:37:34 -0500 Date: Tue, 25 Jan 2000 16:37:34 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: pharm-policy@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] USA seeks to remove IPR section from AIDS resolution at WHO I just heard from people on the ground in Geneva, that the US Government is lobbying to remove language in the World Health Assembly Executive Board Resolution on HIV/AIDS (EB 105/12, on the web at (http://www.who.org/wha-1998/EB105/PDF/ee12.pdf). The Clinton/Gore administration is apparently working with the International Federation of Pharmaceutical Manufacturers, Merck and other parties to remove this language from page 6 of the HIV/AIDS resolution: The Executive Board . . . REQUESTS the Director-General: 7) on their request, to advise governments on their options under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to increase their capacity to negotiate for more affordable HIV/AIDS-related drugs; This is similar to the language that passed the World Health Assembly in 1999, after a bitter two year fight between the developed and the developing countries. The drug companies are very unhappy having the WHO involved in these trade issues, but the USG supposedly just endorsed this for our own trade policy. This is a strange development, coming so soon after Vice President Gore and President Clinton's recent speeches on HIV/AIDs and US trade policy. According to one MSF official, "it is same old same old policy" from the US, and the "US embassy is all over this." Apparently the US government has also asked that other language in the resolution be replaced with language that came from an IFPMA roundtable session on HIV/AIDS. I'll ask for some explanation from the White House, and I would encourage others to make some calls. This is happening right now. The WHA Executive Board will be meeting again tomorrow. Jamie -- James Love, Consumer Project on Technology v. 1.202.387.8030, fax 1.202.234.5176 love@cptech.org, http://www.cptech.org _______________________________________________ Ip-health mailing list Ip-health@lists.essential.org http://lists.essential.org/mailman/listinfo/ip-health James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | love@cptech.org Voice 202/387-8030 | Fax 202/234-5176 From owner-pharm-policy@venice.essential.org Wed Jan 26 02:06:48 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 25E9F21AFF for ; Wed, 26 Jan 2000 02:06:48 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id CAA18111 for ; Wed, 26 Jan 2000 02:06:48 -0500 Date: Wed, 26 Jan 2000 02:06:48 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: pharm-policy@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] More on USG at WHO meeting I talked to a second person in Geneva regarding the World Health Assembly Executive Board (EB) Meeting. Dr. Tom Novotny is leading the US Delegation. He works for Sec. Shalala at DHHS, and he apparently surprised everyone by saying the US government was opposed to the EB resolution language on WHO providing advice to countries on IPR/Trade issues, as it relates to the HIV/AIDS crisis. Dr. Novonty reportedly said that this was something for the WTO or WIPO, (institutions that historically have had the mission of raising levels of IPR protections) and that the US would offer some "new language" on this section. He also said he wanted the EB resolution on AIDS to more reflect the perspectives from the IFPMA (the big Pharma) roundtable, so he wasn't pulling any punches. People were pretty shocked because (a) they thought this issue had been settled in 1999 with the approval of the much debated Revised Drug Strategy, which called for WHO to do this, and (b) President Clinton and VP Gore had both made recently highly publicized speaches about how the US health authories are going to participate in reviews of US trade policy, particuarly in the context on HIV/AIDS. One African country was going to offer as a substitute for the language in paragraph 2.7 the exact language the World Health Assembly passed last year, to force the US to formally oppose something it had already voted for (albeit something they had lobbied against for 2 years). Big Pharam has been very unhappy with WHO involvement in trade issues, particularly after the WHO issued the Red Book/Blue Book, which explained to countries how the TRIPS works and what types of things they could do under the TRIPS to enhance access to essential drugs. The publication of these documents came at a time when the US government and the industry was telling countries a much different story about what TRIPS required. WHO was seen by many as providing a "public defender" type service to the poor countries, giving them some talking points they could use against the very aggressive and powerful US government and industry lobbying efforts. The US was very unhappy about this, but we had thought that the US position had moderated and that they had accepted this. Dr. Novotny's comments reflected more the old hardline viewpoint that was evident prior to May 1999, and was not expected given the President and VP speeches on trade policy. The Clinton/Gore administration have to know how this will be perceived by the groups that worked so hard for two years to get the Revised Drug Strategy passed, and so it is a provcotative statement, to say the least. Even more so is the fact that Dr. Novotny is doing in the context of the WHO resolution on HIV/AIDS, and that at the same time, he is officially asking that the WHO analysis of the HIV/AIDS problem be replaced with language drafted by the drug companies. One has to wonder who is making the decisions about this for now. This had to be cleared by Shalala, and there is evidence that policy on this issue (the trade and health controversy) is being reviewed John Podesta, the White House chief of staff, who apparently modified some of the provisions of the President's December 1 WTO annoucements. I'll ask the Gore people if they agree with the rest of the Administration on the USG proposal to stop the WHO from providing information to poor countries on IPR issues, as they relate to AIDS. Jamie James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | love@cptech.org Voice 202/387-8030 | Fax 202/234-5176 From owner-pharm-policy@venice.essential.org Wed Jan 26 08:16:49 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id D2C4021AFF for ; Wed, 26 Jan 2000 08:16:49 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id IAA20016; Wed, 26 Jan 2000 08:16:49 -0500 Date: Wed, 26 Jan 2000 08:16:49 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: pharm-policy@venice.essential.org, healthgap@CritPath.Org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=ISO-8859-1 Content-Transfer-Encoding: QUOTED-PRINTABLE Subject: [Pharm-policy] CI statement to WHA EB This are the statements made today by Health Action International, on behalf of Consumers International. =20 =20 Jamie >From hai_in_geneva@yahoo.com Wed Jan 26 08:11:13 2000 FINAL 26 January 2000 First statement: Statement on behalf of Consumers International (formerly International Organisation of Consumers' Unions) by Bas van der Heide for WHO Executive Board, 105th session on agenda item: 2 / Public private partnerships for health Mr Chairman, distinguished members of the EB, I am speaking on behalf of Consumers International (CI). I would like to thank you for the opportunity to raise issues of importance to consumers worldwide. On pharmaceutical questions, CI works closely together with Health Action International (HAI), a global network of health, development and consumer groups active in more than 70 countries. On infant feeding CI works with the International Baby Food Action Network (IBFAN). =A0 I would like to say a few words on WHO’s partnership with commercial enrterprises. In a world where healt care systems and services are increasingly being privitised and commercialised, there is an urgent need for WHO to protect its status as a truly independent advocacte for human rights and health for all. As the highest policy setting body on health in the world, WHO has a duty to ensure that its policies, research priorities and direction are not inadvertently subverted in its drive to attract funds and resources.The agenda of profit-making companies is not the same as that of a public body such as the WHO and is at times conflicting. The most important question therefore is whether increased interaction with the commercial sector is a major way forward towards Health For All. WHO must be able to demonstrate that the poor directly benefit from more public-private partnerships. Acceptance of industry partnerships and industry sponsorship without strong, enforceable, accountable and transparent guidelines for these relationships will undermine and destroy the organization's role, responsibility and reputation. In May 1999 HAI wrote to Dr Brundtland expressing serious objections to the secondment of a representative of the pharmaceutical industry to WHO's Tobacco Free Initiative. In October we received a draft of the WHO Guidelines on Interaction with Commercial Enterprises and were invited to comment on them. In our response, we said HAI was pleased to see that WHO was now addressing this important issue which affects the very foundation of its work. The main flaw of the draft guidelines is that they do not give sufficient guidance for a serious evaluation of the activities of potential and current commercial partners and therefore do not substantially reduce the risk of conflict of interest. For example, just as tobacco manufacturers should not be allowed to fund WHO activities, any private enterprise that has a vested interest in infant feeding or the pharmaceutical market must be excluded from such an influential relationship as well. Mr Chairman, members of the Executive Board, we thank you for your attention. =A0 Second statement: Agenda item 3.3 HIV/AIDS Mr Chairman, distinguished members of the EB, I am speaking on behalf of Consumers International (CI), Health Action International (HAI) and the International Baby Food Action Network (IBFAN). Developing countries are facing a crisis involving access to essential medicines. Some essential drugs are unavailable because they are under patent and priced beyond the reach of developing countries. The market fails to provide the solution. Research and development (R&D) on medicines for tropical diseases have come to a near standstill. Patents are an incentive for R&D, but a balance between protecting intellectual property rights and gaining access to essential medicines must be found. The Director-General's report HIV/AIDS: confronting the epidemic (EB105/12) refers to member states' need for advice from WHO on options allowed within the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to increase their access to HIV/AIDS-related drugs. HAI welcomes the fact that countries can now be advised by WHO about the relationship between international agreements and such subjects as drug prices, local production, and licensing agreements. Operative paragraph 2(7) is a crucial part of the draft resolution consistent with the relevant sections of the Revised Drug Strategy resolution WHA52.19. It is unfortunate that the Report by the Director-General on the Revised Drug Strategy (EB105/36, p.4-5) leaves crucial questions unanswered on the next steps involving the important trade and health issue. At the moment there are ongoing country disputes in countries like Thailand, the Dominican Republic and the Philippines involving compulsory licensing of essential medicines, generic prescribing and many other issues. WHO has an important role to play in these discussions and could assist the involved countries and others by developing papers outlining policy options and providing technical advice. We are concerned however that WHO has not yet taken up a very pro-active and visible role in public debates on these issues. During the World Trade Organization (WTO) Third Ministerial Conference in Seattle, for example, TRIPS and access to essential drugs was an important issue for many delegations, but WHO was reactive and, at times, unresponsive. We are pleased that Dr Brundtland has offered to WTO to organize a joint working group on access to medicines and to include major stakeholders in its work. We foresee such a working group considering the impact of trade policies on people in developing and least developed countries, providing a public health framework for the interpretation of key features of WTO agreements. It would also evaluate and propose changes in the WTO rules that would increase access to essential medicines. WHO could play an active role in being the international public health organization outlining the agenda for this working group and providing technical advice. Today there is very little research and development (R&D) on diseases that primarily affect the people living in poor countries. WHO member states should direct WHO to set a clear research agenda and increase public spending to realise these goals. Moreover, these R&D efforts should be designed with access in mind, and address issues such as reasonable pricing and intellectual property rights before huge sums of money are put into new public/private sector partnerships. Finally, a few words about to infant feeding. We are pleased that WHO is now taking the lead in conducting further research on the issue of exclusive breastfeeding and its role in reducing Mother to Child Transmission of HIV. We urge WHO to do everything it can to encourage member states to implement the International Code and the relevant Resolutions in order to protect all infants and carers --whatever their infant feeding decisions-- from commercial promotion. Mr Chairman, members of the EB, we thank From owner-pharm-policy@venice.essential.org Wed Jan 26 08:25:38 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 1BA7A21AFF; Wed, 26 Jan 2000 08:25:38 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id IAA20101; Wed, 26 Jan 2000 08:25:37 -0500 Date: Wed, 26 Jan 2000 08:25:37 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: ip-health@venice.essential.org, pharm-policy@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] WHO drafting group meetings at Lunch today Well, messages posted on the Internet seem to have gotten the attention of the US delegation in Geneva (and others), and we will have to wait to see what emerges from the World Health Assemby Executive Board on the HIV/AIDS resolution. Apparently there is a closed drafting session at noon today. No one has seen the actual language the US will propose, and of course, that may be changing by the minute too. Other countries have some proposals to. There should be some information later today on this. To Dr. Novotny or his colleague, feel free to send us whatever you like and it will be posted here, so you can explain yourself what is going on at the meeting. (Why didn't the US consult with HIV/AIDS activits before they announced they were going to ask for changes in the EB resolution on AIDS?). Jamie James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | love@cptech.org Voice 202/387-8030 | Fax 202/234-5176 From owner-pharm-policy@venice.essential.org Wed Jan 26 08:37:33 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id AE45021AFF for ; Wed, 26 Jan 2000 08:37:33 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id IAA20206 for ; Wed, 26 Jan 2000 08:37:33 -0500 Date: Wed, 26 Jan 2000 08:37:33 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: pharm-policy@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] WHO/IFPMA Round Table Report The IFPMA report that Dr. Novotny referred to is on the IFPMA web page, here: http://www.ifpma.org/pdfifpma/FINAL%20REPORT%20WHO.pdf People might want to take a look at this right now, and offer comments. Jamie -- James Love, Consumer Project on Technology v. 1.202.387.8030, fax 1.202.234.5176 love@cptech.org, http://www.cptech.org From owner-pharm-policy@venice.essential.org Wed Jan 26 15:56:16 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 79FA021AFF for ; Wed, 26 Jan 2000 15:56:16 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id PAA28421; Wed, 26 Jan 2000 15:56:16 -0500 Sender: jamie@genoa.essential.org Message-ID: <388F5F47.B42A86CA@cptech.org> Date: Wed, 26 Jan 2000 15:55:35 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy , healthgap Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] PhRMA press release on TACD statement on R&D For reasons best known to PhRMA, they put out a January 26, 2000 press release attacking the draft TACD statement on transparency on R&D expenditures. The PhRMA press release seems to be based upon some misunderstanding of the IRS data. I don't think they understand that the IRS has the actual claims reqarding qualified R&D expenditures, off the returns, and it was not necessary to make any assumptions regarding the so called "base rate" of expenditures. I was going to do this, but didn't have to when we found out the level of data collection by the IRS was more complete and detailed than we had thought. Indeed, PhRMA has a whole paragraph on this on page two of the press release (which isn't on the PhRMA web page yet). Also, PhRMA makes another mistake and assumes that we derive the numbers for qualifying expenditures from the amount of the credit, which is wrong. The IRS has the actual amount of qualifying expenditure directly from the company tax returns. PhRMA mentions Public Citizen in a way that makes it sound as if this was their work product. Public Citizen did not prepare the draft, CPT did, and it will not be released as a product unless it is approved by the TACD, probably in its Feb 10-12 meeting, after further review and comment by the TACD, an organization representing more than 65 consumer groups in the US and Europe. CPT had actually contacted PhRMA a few days ago and asked Susan Finston if PhRMA could review the data, and explain the disparity between the IRS numbers and the PhRMA survey. I told Susan we would like to include the PhRMA response in anything CPT published on the R&D question. CPT is working on an R&D report that is more extensive than the TACD statement (the TACD statement largely goes to the issue of the need for greater transparency). I'll ask Susan Finston for an electronic copy of the PhRMA press release so you can see what they say. PhRMA does point out that the IRS defines R&D more narrowly than does PhRMA, a point not really in dispute, but it appears to make some further mistakes in describing IRS rules for qualifying expenditures, and adds some confusing items too. For example PhRMA says that the IRS data doesn't include foreign R&D, which is true, but the IRS data were compared to PhRMA's report of US R&D, so it was an apples and apples comparison, at least on this issue. Interestingly, PhRMA doesn't even mention the Orphan Drug Tax credit data, which is pretty hard to explain, I would think. Reading the release, it is fair to say that PhRMA is sensitive about the R&D question, and they rushed a press release out the door that will simply confuse matters even more, given a number of errors and mistatements. And, the PhRMA release is even more evidence of the widespread confusion over these R&D numbers. Jamie -- -- James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | mailto:love@cptech.org Voice 1.202.387.8030 | fax 1.202.387.8030 From owner-pharm-policy@venice.essential.org Mon Jan 24 18:17:28 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from raven.a001.sprintmail.com (raven.prod.itd.earthlink.net [209.178.63.9]) by venice.essential.org (Postfix) with ESMTP id E3DC521B23 for ; Mon, 24 Jan 2000 18:17:27 -0500 (EST) Received: from sprintmail.com (sdn-ar-001dcwashP242.dialsprint.net [168.191.22.4]) by raven.a001.sprintmail.com (8.8.7/8.8.5) with ESMTP id PAA12543 for ; Mon, 24 Jan 2000 15:17:22 -0800 (PST) Message-ID: <388CDD5F.59152098@sprintmail.com> Date: Mon, 24 Jan 2000 18:16:48 -0500 From: MichaelT1 X-Mailer: Mozilla 4.7 [en] (Win98; U) X-Accept-Language: en MIME-Version: 1.0 To: Pharm-policy@venice.essential.org Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] unsubscribe From owner-pharm-policy@venice.essential.org Thu Jan 27 00:31:19 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 4EDD621AFF for ; Thu, 27 Jan 2000 00:31:19 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id AAA03505 for ; Thu, 27 Jan 2000 00:31:19 -0500 Date: Thu, 27 Jan 2000 00:31:19 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: pharm-policy@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] R*D Cost, by component The following is a stylized presentation of a typical "cost of drug development" study. I'm working at home without access to some papers. The data are loosely based upon the DiMasi et al, 1991 study and the 1993 OTA report, but are not exact. For example, I left out the animal studies, and I don't think all the other numbers are quite right, because I'm doing some of this from memory. Joseph DiMasi is on this list, can correct the numbers if we wants to. This is mostly presented to show people how the costs are allocated, so it isn't such a black box. The OTA asked Joseph DiMasi to recalculate his 1991 study numbers, with the assumption that capital costs were 14 percent for the pre-clinical stage, and from 14 to 10 percent for other expenditures (as a linear function). Joe had used the following data for average time from start of a development phase to the NDA, and the phase length, and from that I have calculated the cost of capital figures: Start to Phase mid-point Cost of NDA Length to NDA Capital Preclinical 11.8 3.6 10.00 14.00% Phase I 8.2 1.3 7.55 13.02% Phase II 6.9 2 5.90 12.36% Phase III 5 3 3.50 11.40% NDA Review 2.5 2.5 1.25 10.50% Here I just took the 1991 data on clinical trials and increased them by 12 percent (OTA used 1990 numbers and Joe used 1987 numbers, and I didn't bother to check the CPI), and I assumed the out of pocket pre-clinical expenses were roughly 1 percent of the risk adjusted pre-clinical expenses (Joe didn't break them out separately, and I'm open to suggestion as to how this should have been done.) I have presented four columns. The "out of pocket" column is for the outlays on a particular drug. Most of this is for the clinical trials. The column labeled "risk" is the "cost" of unsuccessful trials, before capital costs. The column "capital" is the cost of capital for both the successful and the unsuccessful trials, using the variable discount rates given above. I have two tables, one that has dollars, and one that has percentages. Table 2 is probably the more useful. In this example, the out of pocket costs are about 6 percent of the total. The risk adjustment, when you throw in the big pre- clinical numbers, are about 27 percent of the total. And the cost of capital is 67 percent of the total -- twice as much as actual outlays, even after adjustments for risk. By stage of development, pre-clinical expenditures are about 78 percent of the total, after risk and capital costs are included. There are several things one can say about this type of analysis. First, if you were to use a discount rate of something close to 9 percent, the cost estimate would fall by nearly one third, on this adjustement alone. Second, if a drug company acquires a product when it is ready for clinical trials (such as d4T, for example), 78 percent of the costs are already gone. Third, very few policy makers understand how to interpret capital costs. How close are these numbers to reality? Well, there are lots of problems with the data. As we know from the Orphan Drug Tax Credit data, the cost of clinical trials can be very small, for some drugs. The assumed 12 years from preclinical to NDA is pretty far off for some classes of drugs, such as HIV/AIDS drugs, for example, where the average time from patent application to NDA approval is only 4.4 years (Particularly considering that in the example above, 67 percent of total costs are capital costs). And we don't have any real data on the pre-clinical stage (which is nearly 80 percent of the total), and this is particularly hard to measure in areas like cancer, HIV/AIDS and other illnesses where the government support for R&D is so large. If people find it useful, I'll redo this using the right numbers from the 1993 OTA study, and run it by Joe to make sure we can agree on the numbers. Jamie Table 1 Allocation by dollars out of pocket risk capital total Pre-Clinical 0.700 70.000 191.401 262.101 Phase I 2.390 8.002 15.791 26.182 Phase II 4.428 5.413 9.732 19.573 Phase III 14.337 6.144 9.404 29.886 21.856 89.559 226.327 337.741 Table 2 Allocation by Percentages out of pocket risk capital total Pre-Clinical 0.21% 20.73% 56.67% 77.60% Phase I 0.71% 2.37% 4.68% 7.75% Phase II 1.31% 1.60% 2.88% 5.80% Phase III 4.25% 1.82% 2.78% 8.85% 6.47% 26.52% 67.01% 100% James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | love@cptech.org Voice 202/387-8030 | Fax 202/234-5176 From owner-pharm-policy@venice.essential.org Tue Jan 25 11:38:11 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from crow.a001.sprintmail.com (crow.prod.itd.earthlink.net [209.178.63.7]) by venice.essential.org (Postfix) with ESMTP id C352821B05 for ; Tue, 25 Jan 2000 11:38:10 -0500 (EST) Received: from sprintmail.com (sdn-ar-004dcwashP317.dialsprint.net [206.133.15.223]) by crow.a001.sprintmail.com (8.8.7/8.8.5) with ESMTP id IAA07710 for ; Tue, 25 Jan 2000 08:38:09 -0800 (PST) Message-ID: <388DD149.FFED0A3A@sprintmail.com> Date: Tue, 25 Jan 2000 11:37:30 -0500 From: MichaelT1 X-Mailer: Mozilla 4.7 [en] (Win98; U) X-Accept-Language: en MIME-Version: 1.0 To: Pharm-policy@venice.essential.org Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] unsubscribe From owner-pharm-policy@venice.essential.org Thu Jan 27 12:23:18 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id AD16321AFF; Thu, 27 Jan 2000 12:23:18 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id MAA10167; Thu, 27 Jan 2000 12:23:18 -0500 Sender: jamie@genoa.essential.org Message-ID: <38907EE6.1E6A889E@cptech.org> Date: Thu, 27 Jan 2000 12:22:46 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy , TACD-PHARMACEUTICAL Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] PhRMA's backgrounder on draft TACD R&D statement This is the PhRMA January 26, 2000 back grounder on the draft TACD statement. As noted in the earlier missive, the PhRMA statement is riddled with errors, for example on the fundemental question of how qualifying expenditures were determined (the IRS itself collects this right from the company returns, and it was not necessary to make the types of assumptions PhRMA alleged were made), on the matching of US version US R&D expenditure (no one compared US to worldwide), and on other items. Apparently PhRMA thought this was something prepared for a Wed press conference organized by Public Citizen, and it was a bit rushed. I told PhRMA I would give them a look at the next version of the TACD statement, and I also gave them a heads up on the fact that CPT would probably issue some type of report on R&D that covered some of these same topics, in the next couple of weeks. Maybe in the next round we can have a debate with less misinformation and confusion. Jamie --------------------------- January 26, 2000 THE PHARMACEUTICAL INDUSTRY'S R&D INVESTMENT Background In the attack du jour on the pharmaceutical industry, critics have charged that the annual estimates of R&D expenditures compiled by the Pharmaceutical Research and Manufacturers of America (PhRMA) are inflated. The charge appears to be based on the erroneous assumption that amounts claimed under the R&D tax credit represent total R&D expenditures. The R&D Tax Credit In fact, the R&D tax credit is based on incremental, or added, spending on a limited category of expenses. Its purpose is to spur companies to increase investment in R&D; it was never meant to include all R&D spending. Moreover, the IRS rules defining expenses eligible for this credit are extremely restrictive. Many expenditures that qualify as research and development expenses under generally accepted accounting principles are excluded. Ineligible expenses include: all R&D equipment costs (including the cost of equipping state-of-the-art laboratories with such expensive tools as screening robotics, high-speed computers, laser capture microscopes and others); fringe benefits paid to employees engaged in R&D; salaries and benefits of many employees supporting and supervising R&D activities; a percentage of the expenses of research conducted on a contract basis, and expenses for R&D paid by a U.S. company for R&D conducted outside the U.S. IRS data show that, as a result of the above restrictions, only about 55 percent of total R&D expenses are qualified expenses for the purposes of the R&D tax credit. The TACD Analysis The Transatlantic Consumer Dialogue (TACD), an organization affiliated with Ralph Nader's Public Citizen, attempted to estimate total pharmaceutical industry R&D expenditures based on the R&D tax credit used by taxpayers to reduce tax liability. While the TACD analysis attempts to take into account the fact that the credit is only for incremental, or added, R&D expenditures, it arbitrarily assumes a base of 50 percent. In other words, it assumes that current year R&D is double the average of the previous four years' R&D expenditures. This is unrealistic. Only start-up companies and other very rapidly growing companies have such a low base. For more mature companies, a base of 80 to 90 percent is more realistic. This means that mature companies increase R&D by 5 to 15 percent each year. In fact, the PhRMA Survey for calendar year 2000 estimates an increase in industry R&D spending of 10.1% over 1999. By assuming a universally low base, the TACD analysis seriously underestimates R&D expenditures. Finally, the TACD analysis assumed all taxpayers received a 20 percent credit for incremental qualified expenditures. In fact, a number of taxpayers choose an alternative 13 percent credit to avoid an R&D deduction disallowance that is required if the 20 percent credit is claimed. PhRMA's Annual Surveys Every year, PhRMA surveys its member companies -the country's leading pharmaceutical and biotechnology companies -on their individual R&D expenditures. These expenditures are defined as the total costs incurred for all pharmaceutical research and development activity, including salaries of employees who conduct, support or supervise R&D; supplies and equipment used in R&D; a fair share of overhead; contract research expenditures; the costs of synthesis and extraction of compounds; the costs of laboratory testing (pre-clinical); expenditures involved in formulating the dosage and testing the stability of compounds; the expenditures incurred in three-stage, FDA-supervised clinical trials; the costs of post-marketing studies, and bioavailability studies. The most recent survey found projected R&D expenditures for 2000 of $26.4 billion. This figure represents a 10.1 percent increase over 1999 R&D expenditures of $24 billion. Other Government Data Sources The National Science Foundation collects and publishes annual R&D expenditures by industries. That data, when adjusted to take into account the different categories between PhRMA surveys and the NSF survey, is consistent with the R&D expenditure figures published by PhRMA. For 1996, NSF data show $9.8 billion for domestic research performed by pharmaceutical companies, plus an additional $2.1 billion of pharmaceutical industry domestic contract research. The PhRMA survey includes all biomedical research, including biotech, which is included in a larger NSF category for "Research, Development and Testing." The amount in that NSF category is $5.9 billion, a substantial portion of which relates to biomedical research. The Fruits of R&D Anyone who questions the fact that pharmaceutical companies are investing heavily in R&D should look at the results of that investment -"the proof of the pudding." Last year alone, pharmaceutical companies added 40 new treatments to the nation's medicine chest. The new medicines target 36 diseases with a total patient population of 545 million and a total annual cost of $600 billion. In the last decade of the 20th century, companies made a total of 370 new medicines available -up from 239 in the previous decade. The medicines of the 1990s included breakthrough medicines for AIDS, cancer, stroke, depression, schizophrenia, arthritis and many other diseases. The Rising Cost of R&D According to the Boston Consulting Group, the average cost of development a new drug is about $500 million, including the cost of research failures as well as interest costs over the period of investment. Drug development costs are increasing due to a number or reasons, including more clinical trials, usually involving more patients and more procedures, and the fact that companies are attacking more and more difficult diseases. Prices vs. Expenditures Critics of the pharmaceutical industry tend to confuse "drug prices" with total "drug expenditures." Total expenditures for pharmaceuticals increased by 15.7 percent in 1998. But, according to IMS Health, the average cost of a prescription Medicine increased by a modest 3.2 percent. In other words, because more patients got more and better medicines, even if there were no price increases, total expenditures would have increased by 12.5 percent. Rising drug expenditures represent a sea change that is occurring in health care. Prescription drugs are an increasingly important treatment option, which can often keep people out of hospitals, nursing homes and surgical suites. They are the most cost-effective, least invasive form of health care. The share of total health care expenditures represented by outpatient prescription drugs is only in the single digits, currently 7.9 percent. That figure is inching up every year because patients, physicians and insurers are increasingly turning to prescription drugs. Still, it should be noted that since outpatient drugs account for only 7.9 percent of health care expenditures, even a 15.7 percent increase in total drug expenditures is a good investment in effective and cost-effective treatment of patients. Coverage is Key The fact that prescription drugs are the most cost-effective and least invasive health care treatments means that prescription drug coverage is increasingly important. This is especially true for seniors, who use more prescription medicines than younger Americans. Medicare's lack of coverage of prescription drugs is truly an anachronism. That's why PhRMA supports enhancing drug coverage for seniors. We want to do this in a way that provides quality health care for seniors while preserving the incentives to invest in pharmaceutical R&D. James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | mailto:love@cptech.org Voice 1.202.387.8030 | fax 1.202.387.8030 From owner-pharm-policy@venice.essential.org Thu Jan 27 12:28:51 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 273D621AFF for ; Thu, 27 Jan 2000 12:28:51 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id MAA10252 for ; Thu, 27 Jan 2000 12:28:51 -0500 Sender: jamie@genoa.essential.org Message-ID: <38908033.E51F4F6D@cptech.org> Date: Thu, 27 Jan 2000 12:28:19 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Jim Keon on Canada/EU/WTO dispute and Article 27.1 ------------------- Subject: RE: [Ip-health] One more thing on Canada WTO case Date: Wed, 26 Jan 2000 10:52:24 -0500 From: Jim Keon Organization: Canadian Drug Manufacturers Association To: "'James Love'" The Canadian patent exception for early working applies to any sector where regulatory approval is required prior to marketing. Thus, it can cover the use of patents to develop competing products in sectors such as medical devices or agricultural chemicals in addition to pharmaceuticals. Because of this, the EU contention that the Canadian early working provisions are discriminatory shows a lack of understanding of Canadian law. This means that we are unlikely to know from the Panel's decision in the Canada-EU case whether or not an early working provision just for pharmaceuticals would be a violation of Article 27 of TRIPs. -----Original Message----- From: James Love [SMTP:love@cptech.org] Sent: Tuesday, January 25, 2000 11:13 AM To: ip-health@venice.essential.org Subject: [Ip-health] One more thing on Canada WTO case Another issue in the Canada case is the EU contention that the Canada Bolar exception violates the TRIPS Article 27.1 antidiscrimination rules for patents. If Canada is permitted to provide early working for pharmacueticals, then the WTO seems to be rendering a decision that Article 27.1 requires that while all fields of technology be covered by patents, countries can adopt differential rules to for fields of technology, to address social objectives, so long as those differences are consistent with the TRIPS. This, of course, is just my guess, and I would appreciate comments on this important issue. I haven't seen the EU pleading in this case. We have seen a few documents from the Canada side, such as the items they put on the web. (Why doesn the EU put its briefs on the web, so its own citiznes can find out what their foreign policy is?) Jamie ------------------- James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | love@cptech.org Voice 202/387-8030 | Fax 202/234-5176 -- James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | mailto:love@cptech.org Voice 1.202.387.8030 | fax 1.202.387.8030 From owner-pharm-policy@venice.essential.org Thu Jan 27 13:08:18 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id A262421B10 for ; Thu, 27 Jan 2000 13:08:18 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id NAA11007 for ; Thu, 27 Jan 2000 13:08:18 -0500 Sender: jamie@genoa.essential.org Message-ID: <38908972.946EF68@cptech.org> Date: Thu, 27 Jan 2000 13:07:46 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] lack of transparency at NIH on patent licenses For about one year we have been asking the US government to tell us if the US government gave Bristol-Myers Squibb an extension of the 10 year period of exclusivity on the ddI patent license. I have the original ddI license agreement, which was effective February 1, 1988. BMS was granted a 10 year period of exclusivity, following "the date of the first commercial sale" of ddI in the USA. However, BMS could ask for an extension. The FDA approved ddI for sale on October 9, 1991. The 10 years is up next year, and it will be interesting to see what happens to the price if and when it becomes a generic in the USA. However, in the past, the US government has liberally granted license extensions to BMS. So we have been asking for one year, has the US done this or not? Most recently, I wrote the NIH licensing people and asked again. I was told submit a FOIA request. These FOIA requests cause everyone lots of grief, and take forever. But this is the NIH policy. If you want to know a basic question about a drug company's exclusive rights over government funded life saving technologies, you have to force us to provide this information. Fine. We will file the FOIA, and wait months for the answer, already having waited nearly a year since we asked Shalala's office to provide this information. Thanks Donna. Jamie -- James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | mailto:love@cptech.org Voice 1.202.387.8030 | fax 1.202.387.8030 From owner-pharm-policy@venice.essential.org Thu Jan 27 13:56:23 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 11B2C21AFF for ; Thu, 27 Jan 2000 13:56:23 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id NAA12038; Thu, 27 Jan 2000 13:56:20 -0500 Sender: jamie@genoa.essential.org Message-ID: <389094B5.E048C6C0@cptech.org> Date: Thu, 27 Jan 2000 13:55:49 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] USTR sends new letter to Thailand - decision on CL is "one for Thailand to make" The White House has just provided a letter that was send an hour ago to Thailand. The new letter, which was requested by CPT, Act Up, MSF and the other members of the Health Gap Coalition, tells the Thai government that the US will raise no objection to the issuance of a TRIPS compliant compulsory license, and that the decision to issue such a license is "one for Thailand to make." We have a hard copy, will be scanning this in for the web, so people can get a facsimile that includes the USTR letterhead and Joe Papovich's signature. Without going into the details, I will say that the Office of the Vice President was very helpful in getting this letter out the door. Jamie Love <-------------------begin USTR letter---------------------> EXECUTIVE OFFICE OF THE PRESIDENT OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE WASHINGTON, D.C. 20508 Jan 27 2000 Mr. Paisan Tan-Ud Chairman of PHA Network of Thailand Dear Mr. Paisan Tan-Ud: I am writing in response to your letter to President Clinton regarding efforts to improve access to treatment and care for HIV positive Thai citizens. We recognize and support the Government of Thailand's goal of extending effective health care to all its citizens-including people now living with AIDS. This is a goal we fully endorse and believe can be achieved while providing appropriate protections for intellectual property. As the President announced last December in his speech to the WTO ministerial, and the Vice President reiterated in his January speech at the United Nations Security Council, the United States is committed to helping developing countries gain access to affordable medicines, including those for HIV/AIDS. As a result, the United States will ensure the application of U.S. trade law related to intellectual property remains sufficiently flexible to respond to public health crises. We encourage Thai officials to explore all options for extending access to effective treatments, including ongoing direct dialogue with pharmaceutical manufacturers. But the final choice is one for Thailand to make. If the Thai government determines that issuing a compulsory license is required to address its health care crisis, the United States will raise no objection, provided the compulsory license is issued in a manner fully consistent with the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). We share with the Government of Thailand a belief that access to modern pharmaceuticals can be enhanced in a manner that assures the safety and efficacy of the drugs, preserves intellectual property rights, and promotes the worldwide pursuit of newer, more effective medicines. Sincerely, Joseph S. Papovich Assistant U.S. Trade Representative for Services, Investment and Intellectual Property <------------------end USTR letter--------------------> -- James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | mailto:love@cptech.org Voice 1.202.387.8030 | fax 1.202.387.8030 From owner-pharm-policy@venice.essential.org Thu Jan 27 18:04:47 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 96C8221B0E; Thu, 27 Jan 2000 18:04:47 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id SAA17603; Thu, 27 Jan 2000 18:04:47 -0500 Sender: jamie@genoa.essential.org Message-ID: <3890CEF2.68772016@cptech.org> Date: Thu, 27 Jan 2000 18:04:18 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Cc: "Dr. Thomas Novotny" Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Dr. Thomas Novotny's response regarding WHA Executive Board meeting Subject: Response to email Date: Thu, 27 Jan 2000 17:54:01 -0500 From: TNovotny@osophs.dhhs.gov (Thomas Novotny) To: love@cptech.org, JWright@osophs.dhhs.gov (Jason Wright) Jason: please distribute to Stu, USTR, David Hohman, Ken Bernard, etc. Jamie: I trust that when you distribute this email, you will not edit it in any way. I feel that I need to clarify a few things noted in your recent email traffic (Jan 27) that without clarification might constitute misrepresentation. I am the head of the US Delegate to the WHO Executive Board, and I led a five-person delegation, including Stuart Nightingale, to the ongoing meeting of the Board. In preparation for this meeting, the USG had developed carefully worded interventions in response to the WHO paper on HIV/AIDS. These interventions were vetted around DHHS and other agencies, but our corrections to the WHO draft resolution are subject to a fairly intense consensus process based on vigorous, straightforward exchange with our fellow board members. Although I, as the head of delegation, encouraged the other members of my team to get input from all interested parties, including NGOS and pharmaceutical representatives, I had no contact with any of these groups outside of the meeting I attended with USTR and the invited NGOS earlier this month. 1. You stated that the Clinton/Gore administration "is apparently working with the International Federation of Pharmaceutical Manufacturers, etc." to remove language from the resolution that you described as "similar to the language that passed the World Health Assembly in 1999." This is completely erroneous on two counts: 1) we are not working with anyone but the USG to contribute to the drafting of the resolutions; this is what we get paid for, and as stated above, our contributions are based on cleared language from the Department and other agencies. 2) We fought hard (and succeeded) to get IDENTICAL language to the Revised Drug Strategy that was the product of intense negotiations at the last World Health Assembly. This language is now included in preamble of the resolution and later with wording that replaces the flawed clause 2(7) that you quoted in your email. The language was agreed on by consensus among a drafting group that included African nations, India, European countries, and Chile, among others. I think there was little dissention to the following language (which we insisted recall the Revised Drug Strategy). In preamble: "Recalling resolution WHA52.19 as approved by the 52nd World Health Assembly, which inter alia requests the Director-General to cooperate with Member States at their request, and with international organizations in monitoring and analysing the pharmaceutical and public health implications of relevant international agreements, including trade agreements, so that Member States can effectively assess and subsequently develop pharmaceutical and health policies and regulatory measures that address their concerns and priorities, and are able to maximize the positive and mitigate the negative impact of those agreements;" As for removing the IPR-related language, we opposed this because it went beyond what was agreed to in the Revised Drug Strategy; following is Clause 2(12) replacing 2(7): TO COOPERATE WITH GOVERNMENTS AT THEIR REQUEST AND OTHER INTERNATIONAL ORGANIZATIONS REGARDING POSSIBLE OPTIONS UNDER RELEVANT INTERNATIONAL AGREEMENTS, INCLUDING TRADE AGREEMENTS TO IMPROVE ACCESS TO HIV/AIDS-RELATED DRUGS; We believe this covers WHO responsibilities and opportunities to work with WTO and WIPO on trade agreements to improve access to drugs (just as USDHHS now cooperates with USTR to insure the flexibility of US Trade Policy in health crises). 2. You suggested that we were trying to include language from the IPFMA. That is completely wrong. The language we support is based on our conversations with the WHO Secretariat and which was also published as a result of the first IPFMA-WHO Roundtable on Pharmaceuticals. I believe this product is a result of the pursuit of "dialogue with the pharmaceutical industry" referred to above. WHO agreed to it, and we think it makes perfect sense. We developed as new clause 2(9): "to pursue dialogue with the pharmaceutical industry with a view to making HIV/AIDS-related drugs increasingly accessible to Member States and their populations through drug development, cost reduction, and strengthening reliable distribution;" and new clause 2(10): "to reinforce, promote, and explore partnerships in order to make HIV/AIDS-related drugs accessible through affordable prices, adequate financing, and effective health-care systems, and to ensure that drugs are safely and effectively used;" We believe this wording represents a comprehensive approach to drug accessibility and care. I believe that the EB will think so too, as we have had frank, open, and productive discussions to reach agreement. I think that what we have said here is perfectly consistent with what the VP spoke about at the UN Security Council; what it does not do, and we feel strongly that it must not do, is refer solely to price as the answer to accessibility. Please feel free to let me know how "drug development, cost reduction, and strengthening reliable distribution" or "affordable prices, adequate financing, and effective health-care systems" do not lead to improved accessibility. Again, we worked hard not to let only the price issue drive accessibility concerns. To limit accessibility concerns only to price would be terribly mistaken. Your position on this is far to narrow. Price reduction is only one tool to improve access. Drugs could be free and still not be effective without effective health care systems. In fact, they would rapidly become ineffective. Finally, you must now realize the dialogue that continues between DHHS and USTR is already showing results. Today, USTR released a paper in which they stated, "If the Thai government determines that issuing a compulsory license is required to address its health care crisis, the United States will raise no objection, provided the compulsory license is issued in a manner fully consistent with the WTO Agreement on Trade Related Aspects of Intellectual Property RIghts (TRIPS)." We are still working on the details of our collaboration, and during my visits here to WHO and UNAIDS, we obtained important input on just how we might work with USTR to follow through on the President's directives. We still need more time to work this out, but we consider it a major priority for our Global Health Strategy on HIV/AIDS. On a personal note, Jamie, this is the second time you have disseminated factually incorrect information around the world regarding our work with USTR, and now about our work with the WHO Executive Board. This only damages our relationship with the NGOS and undermines our work with WHO. I am sure that is not your objective, and I hope you will try harder to represent our actions with more balance and accuracy. -- James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | mailto:love@cptech.org Voice 1.202.387.8030 | fax 1.202.387.8030 From owner-pharm-policy@venice.essential.org Fri Jan 28 07:50:28 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 84CD721B05; Fri, 28 Jan 2000 07:50:28 -0500 (EST) Received: from milan.essential.org (milan.essential.org [216.0.124.12]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id HAA24541; Fri, 28 Jan 2000 07:50:28 -0500 Date: Fri, 28 Jan 2000 07:50:28 -0500 (EST) From: James Love X-Sender: love@milan.essential.org To: ip-health@venice.essential.org, pharm-policy@venice.essential.org Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=US-ASCII Subject: [Pharm-policy] Letter from Thai Academics to USTR regarding PhRMA NTE submissions Tido has sent us a copy of this open letter from Thai academics to Charlene Barshefsky at USTR, responding to the recent PhRMA report on Thailand (http://www.phrma.org/issues/intl/nte.html). --------------------------------------------------- Dear Ambassador Barshefsky We are concerned that the National Trade Estimate Report on Thailand that PhRMA has submitted to the US government will negatively influence the year 2000 USTR NTE report. We are writing to ask the USTR to abstain from its previous 'TRIPS PLUS" approach and to carefully review the accusations on Thailand that PhRMA has made. The PhRMA report claims that Thai law is still not TRIPS compliant in many points. 1. Regarding S. 9(1) of the Patent Act. The Report suggests that the provision is against the TRIPs Agreement since it excludes naturally existing biologicals. Art. 27.3(b) of the TRIPs authorized the Member states to exclude living organisms other than microorganisms. Thai law does not exclude all kinds of microorganism but only those organisms that exist in nature. This is not against the spirit of the international agreement as microoganisms that are not technically created are not considered invention. They are merely discovery and no country's law protects discovery. 2. The PhRMA report attacks the Bolar type provision that is part of patent law in many countries. As to Section 36(4) of the Thai Patent Act, the law exempts from patent infringement the use of patented products for market approval during the duration of the patent. This is again not contrary to the TRIPS because the patent holder continues to enjoy market exclusivity during the patent term. The use of patented products for clinical trials is further not a commercial use and does not affect the patent rights. Generic drugs can be released into the market only after the patent expires. Without Bolar provisions patent protection is in practice unfairly extended beyond the current 20 years. 3. PhRMA comments that absence of local working is reason for compulsory license in Thai law. It is true that failure to manufacture the patented product in the country is one of the grounds for the application of compulsory license under Section 46 of the Thai Patent Act. However we do not believe that TRIPS obliges member states to recognize importation as sufficient working of the patent. Following active USTR intervention under "special 301" the Thai government adopted regulations in 1993 that restrict the use compulsory license as to Section 46 of the Thai Patent Act. The regulations broadly exclude many reasons for compulsory license, including importation. 4. We disagree that the provision on dependent compulsory licences is not in line with the TRIPS. Art. 31(j) of the Agreement states "any decision relating to the remuneration provided in respect of such use shall be subject to judicial review or other independent review by a distinct higher authority in the Member". Though the Thai law does not provide for judicial review in this case, the affected party is able to appeal the decision to grant a compulsory licence to the Patent Board, which comprises representatives from various sectors and is absolutely independent from government control. 5. As to Section 6(4), Thailand recognizes a 12-month priority period for foreign applications, not 18 months as mentioned in the PHRMA report. This is found in Section 19 B of the Thai Patent Act, not in Section 6(4). Section 6(4) applies the 18-month period because in most countries patent applications are published for public scrutiny after 18 months from the filing date. This is a normal practice in most countries and does not fall outside the scope of the TRIPs. 6. Regarding the Draft Trade Secret Law, the "public interest" provision can be found in all countries' intellectual property law. We are surprised that PHRMA considers this provision illegal. 7. PhRMA mispresents facts on parallel import in Thailand and speaks of "the dangers that such imports pose to national health". PhRMA confuses illegal smuggling of counterfeit drugs into Thailand with the legal parallel importing under the supervision of the Thai FDA. All imported drugs need to be registered with the FDA and are assessed according to quality, safety and efficacy. Section 36(7) of Thai Patent Law now authorizes parallel importation. "The TRIPS Agreement explicitly states that if a country allows parallel imports - that is, imports of goods already put on the market in another country with the right holder's authorization - those practices cannot be challenged under the Agreement" (Text of the official WTO booklet to the Seattle meetings). 8. PhRMA complains that drugs still under the Safety Monitoring Program can not be included in the National List of Essential Drugs (NLED). PhRMA believes that the Thai government is setting up market access barriers by using the NLED as a maximum list for government hospitals and by setting maximum prices for drugs in the NLED. a) Making the NLED a minimal rather than a maximum list in public hospitals as PhRMA suggests would undermine the very concept of an essential drug list as is it is promoted by WHO. The rationale for the use of a limited number of essential drugs is that it leads to an improved supply of drugs, more rational prescribing and lower costs. b) Following pressure by the USTR the Thai government is since 1994 providing 5- years of market exclusivity as pipeline protection of drugs. This protection is given under the cover of the Safety Monitoring Program (SMP) that provides extremely limited safety data due to the passive monitoring system; so far SMP has in no case detected safety problems that were not reported earlier in other countries. Pharmaceutical companies were thus given pipeline protection and "safety monitoring" purely to grant market monopoly; how can PhRMA now demand that provisionally registered pipeline drugs should be included in the NEDL? c) Price control of medicines is a legitimate way of increasing affordability of drugs and is clearly permissible under TRIPS. Thailand has made very limited use of price control. Most medicines on the NLED are still not affordable for the majority of people and are reimbursed only for the small group of people covered by social insurance. Pharmaceutical companies have repeatedly emphasized that public health policy rather than price is the main obstacle to insufficient access to medicines. PhRMA here actively attempts to undermine good, WHO recommended standards of national drug management. We are seriously concerned that PhRMA policies negatively affect public health in Thailand if given impact on the USTR NTE report. We urge the USTR to consult with DHHS on this issue as was announced by President Clinton during the 1999 Seattle meetings. Sincerely, Jakkrit Kuanpoth, PhD Associate Professor, School of Law Sukhothai Thammathirat University, Thailand Jiraporn Limpananont, PhD Associate Professor, Faculty of Pharmaceutical Sciences Chulalongkorn University, Thailand From owner-pharm-policy@venice.essential.org Fri Jan 28 09:47:02 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 6C05A21B05 for ; Fri, 28 Jan 2000 09:47:02 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id JAA25888 for ; Fri, 28 Jan 2000 09:47:02 -0500 Sender: jamie@genoa.essential.org Message-ID: <3891ABCF.453414D6@cptech.org> Date: Fri, 28 Jan 2000 09:46:39 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] HAI on WHO-EB HIV/AIDS resolution Subject: EB105 adopts HIV/AIDs resolution Date: Fri, 28 Jan 2000 01:57:49 -0800 (PST) From: Bas van To: love@cptech.org, hayeswaller@compuserve.com CC: Daniel_Berman@geneva.msf.org For posting.. -- Dear friends, I wanted to update you on the WHO-EB, in particular on the resolution on HIV/AIDS. Today the EB has endorsed the draft resolution on HIV/AIDS: confronting the epidemic. The text will soon be posted on the WHO web. Please check http://www.who.int/wha-1998/EB105/anglais.htm The document will be listed on the left at the bottom as EB105/R.. This resolution will now be recommended for adoption by the World Health Assembly in May. The resolution is four pages long and needs to be read in full in order to understand the context. The sections that are interesting to share right now are those referring to the trade agreements. This was an issue for which a drafting group has developed alternative wording. The explanation by Dr. Thomas Novotny that Jamie posted on Pharm-policy clarifies the US concerns with the original wording and gives some insight in the negotiations. In the preamble the text now includes: "Recalling resolution WHA52.19 which inter alia requests the Director-General to cooperate with Member States, at their request, and with international organizations in monitoring and analysing the pharmaceutical and public health implications of relevant international agreements, including trade agreements, so that Member States can effectively assess and subsequently develop pharmaceutical and health policies and regulatory measures that address their concerns and priorities, and are able to maximize the positive and mitigate the negative impact of those agreements" Under the operative paragraphs it requests the Director- General: (9) to pursue dialogue with the pharmaceutical industry with a view to making HIV/AIDS-related drugs increasingly accessible to the population of Member States through drug development, cost reduction, asnd strenghtening of reliable distribution systems; (10) to reinforce, promote, sand explore partnerships in order to make HIV/AIDS-related drugs accessible through affordable prices, adequate financing and effective health-care systems, and to ensure that drugs are safely and effectively used; (11) to cooperate with governments, at their request, and other international organizations on possible options under relevant international agreements, including trade agreements, to improve access to HIV/AIDS-related drugs; I leave it up to you all to interpret this text. I am puzzled with the section on partnership (with whom?), but is certainly the buzz-word for the new WHO. I am convinced that the main issue for the NGO community is to continue to urge contries to use the options they have under the trade agreements in trying to improve access to essential drugs. The Thai case shows that this needs action at both national level and strong support from NGOs elsewhere. At least, as far as I can see, this resolution does not limit the mandate that the WHO had obtained with the Revised Drug Strategy resolution last year. At the EB we have expressed concerns that the WHO so far has not been very pro-active on implementing this mandate. For a copy of our interventions please cleck the HAI website http://www.haiweb.org Best regards from Geneva, Bas van der Heide James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | mailto:love@cptech.org Voice 1.202.387.8030 | fax 1.202.387.8030 From owner-pharm-policy@venice.essential.org Fri Jan 28 15:04:38 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id C18FB21B05 for ; Fri, 28 Jan 2000 15:04:37 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id PAA31729 for ; Fri, 28 Jan 2000 15:04:37 -0500 Sender: jamie@genoa.essential.org Message-ID: <3891F641.513D2BBC@cptech.org> Date: Fri, 28 Jan 2000 15:04:17 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Reply to Dr. Novotny I appreciate Dr. Thomas Novotny's willingness to provide information about the US government's positions at the WHO Executive Board (EB) meetings in Geneva this week, and welcome a continued dialogue on these matters, so that US policy is truly transparent. One can draw different conclusions as to how and why US policy evolved as it did over the past week in Geneva and at USTR, and I will not address these issues in detail in this note. I remain somewhat puzzled over the US government (USG) policy with respect to the WHO and trade policy, including trade policy as it relates to intellectual property rights on pharmaceuticals. I would appreciate a clarification from Dr. Novotny on a few points. And since Dr. Novotny is concerned about the US government position being misrepresented, I would encourage him to respond directly, once again. Several persons in Geneva have reported that Dr. Novotny expressed opposition to the WHO playing a role in policy making on intellectual property right (IPR) issues, and Dr. Novotny acknowledges that the USG did ask that the EB remove the following language from the original EB AIDS resolution: The Executive Board . . . REQUESTS the Director-General: 7) on their request, to advise governments on their options under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to increase their capacity to negotiate for more affordable HIV/AIDS-related drugs; According to Dr. Novotny, "we [the USG] opposed this because it went beyond what was agreed to in the Revised Drug Strategy." I would point out that "going beyond" the RDS isn't bad, from our point of view, and in any case, it is a stretch to say this is "going beyond." It looks to me like an effort to implement the RDS, and to give some plain language support for WHO doing something useful on IPR issues. In any event, the language Dr. Novotny did not like was later replaced, by the EB, which this language: To cooperate with governments at their request and other international organizations regarding possible options under relevant international agreements, including trade agreements to improve access to HIV/AIDS-related drugs; Dr. Novotny says: "We believe this covers WHO responsibilities and opportunities to work with WTO and WIPO on trade agreements to improve access to drugs (just as USDHHS now cooperates with USTR to insure the flexibility of US Trade Policy in health crises)." Which is true, but it is certainly less specific with regarding the IPR than was the language it replaced. I had predicted earlier and Dr. Novotny points out now, language was added to make reference to the RDS. However, again the words intellectual property rights don't appear in the AIDS resolution. The new "sanitized" version of the AIDS resolution doesn't mention patents or intellectual property rights anywhere anymore, as if this isn't a matter of controversy the should be addressed by the WHO. Dr. Novotny's interventions as to how WIPO and the WTO should be the lead players on this issue, and his efforts to remove reference to intellectual property rights from the document, have given us a new more industry friendly resolution. Dr. Novotny also takes credit for inserting more of the familiar "industry partnership" language into the resolution, specifically on the issue of pricing problems. So, while Vice President Gore on the campaign trail is concerned about price gouging by the drug companies, WHO is to told to "reinforce, promote, and explore partnerships" with the drug companies, to make drugs more affordable. Addressing a red herring, Dr. Novotny says "what it [the AIDS resolution] does not do, and we feel strongly that it must not do, is refer solely to price as the answer to accessibility." To drive the point home and make it personal, Dr. Novotny says: "Again, we worked hard not to let only the price issue drive accessibility concerns. To limit accessibility concerns only to price would be terribly mistaken. Your position on this is far too narrow. Price reduction is only one tool to improve access. Drugs could be free and still not be effective without effective health care systems. In fact, they would rapidly become ineffective." Now I don't recall ever saying that accessibility concerns are limited to issues of price, and I don't know any serious people who would say this. Perhaps Dr. Novotny will issue a similar statement lambasting those who advocate investments infrastructuring saying: "Again, we worked hard not to let only the infrastructure issue drive accessibility concerns. To limit accessibility concerns only to infrastructure would be terribly mistaken. Your position on this is far to narrow. Infrastructure investment is only one tool to improve access. The infrastructure could be world class, and if drugs were unaffordable, people would still die." Of course, it would be a taboo for a public health official to issue such a statement, because it would undermine funding for health care infrastructure, which we all agree is important. And more importantly, it should be obvious to most people that both issues (and many others) are important. Of course, intellectual property issues are more controversial than spending on public health professionals. This is because the drug companies care about this issue a lot. Dr. Novotny then says: Finally, you must now realize the dialogue that continues between DHHS and USTR is already showing results. Today, USTR released a paper in which they stated, "If the Thai government determines that issuing a compulsory license is required to address its health care crisis, the United States will raise no objection, provided the compulsory license is issued in a manner fully consistent with the WTO Agreement on Trade Related Aspects of Intellectual Rigths (TRIPS)." Now, with all due respect to Dr. Novotny, I find it amazing that he would pick this example, because as far as I know (and I know a lot on this one), DHHS had nothing to do with the USTR/Thailand letter. The NGO lobbying on this issue could not have been more intense, and no one was talking with (or about) DHHS at all. I wouldn't mind Dr. Novotny claiming credit for future Act UP!, MSF, CPT campaign efforts, if he plays a role of some type, and we look forward to the day when he does. Here are questions for Dr. Novotny: 1. Will the US government support or oppose WHO playing an active and indeed a pro-active role providing poor countries with information on IPR disputes as they related to trade policy and public health? 2. Would you oppose or not oppose the publication of a paper by the WHO that would call for "fast track" compulsory licensing of essential medicines in poor countries? 3. Will DHHS intervene with USTR on the dispute over the Dominican Republic's proposed patent law, which includes fast track compulsory licensing? 4. Will you support or oppose our request that the USTR provide a communication to the WTO on the issue of patent exceptions (under Article 30) for production for export? (Needed for poor countries to benefit from compulsory licensing.) PUBLIC CONSULTATION I would also like to comment on consultation with the public. When Dr. Novotny met with about a dozen HIV/AIDS, public health and consumer groups on January 12, to discuss trade policy as it relates to IPR and pharmacueticals, he never mentioned that the USG had a problem with the December 22, 1999 draft of the WHO AIDS resolution. None of the many groups that I work with was given a heads up that the US would ask that the language on intellectual property rights be removed. I think it should be clear that it is possible to consult with interested parties in advance, and it should be obvious who the interested parties are. As Dr. Novotny notes, the USG solicited input from pharmaceutical companies. My advice is pick upon the phone and raise these issues before, to see how it is going to be received by consumer interests and public health groups (including ones not funded by drug companies). Final comments We are facing a big crisis in access to medicines, and the issues will become even more explosive with the next generation of medicines, which should include products that will be better for use in developing countries. (For example, from a compliance point of view, or products that actually cure conditions). We want our government, the USG, to be strong for the poor. We want the USG to say things in international forums that make us proud. For decades, the USG has been strong for the rich and powerful. In the WHO, the USG has a well deserved reputation for being very strong for the drug companies. We want to see a change. The drug companies have plenty of power already. They don't need our government to act as their guardian angel or global apologist. There are many good points you can make for the drug companies. You can repeat the IFPMA talking points endlessly, including the ones that even we would agree with. You can talk about the virtues of protecting intellectual property, the need to develop new medicines, and you can explain how it isn't all their fault. And even after you remove all the exaggeration and eliminate patently false claims, they will still have some good points. We recognize this as well as anyone. And by repeating these points endlessly, you will make them even stronger. But there are another set of talking points that are not on the IFPMA web page. The IFPMA doesn't point out that compulsory licensing is part of the TRIPS, or that it permits governments rather than companies to determine how much money the poor should pay for patents. The IFPMA has its favorite parts of the TRIPS, but it leaves out the parts that give rights to the poor. The IFPMA doesn't provide accurate information about the costs of drug development or the role of taxpayer supported research in the development of essential medicines. The IFPMA doesn't discuss the high pricing of government funded pharmacuetical inventions. The IFPMA doesn't talk about the pricing of fluconazole, and how this medication can help AIDS patients right now, for a tiny fraction of the Pfizer price. The IFPMA doesn't talk about how the industry uses the legal system to block the introduction of generic drugs, or how costly and difficult it is for poor countries to litigate against the best law firms in world. The IFPMA doesn't talk about how it can get patents in developing countries that would not pass the examination process in the USA. The IFPMA doesn't talk about the importance of domestic industries in providing generic competition. The IFPMA doesn't talk about abuses of the US orphan drug marketing exclusivity, the abuses of health registration data exclusivity, or the countless other regulatory barriers they lobby for. There are lots of things the IFPMA doesn't talk about. So by using your position to advance the IFPMA agenda, you leave out other agendas, and other talking points. The world for the poor is the same world for the rich, but it is perceived differently. Try to see things from the point of view of the poor. Make the poor more powerful. This is what we are asking. Jamie Love -- James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | mailto:love@cptech.org Voice 1.202.387.8030 | fax 1.202.387.8030 From owner-pharm-policy@venice.essential.org Fri Jan 28 15:47:04 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 87E1C21B13 for ; Fri, 28 Jan 2000 15:47:04 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id PAA32506 for ; Fri, 28 Jan 2000 15:47:04 -0500 Sender: jamie@genoa.essential.org Message-ID: <38920034.1E6F4EB6@cptech.org> Date: Fri, 28 Jan 2000 15:46:44 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Greg Perry on EU and Health Registration Data These are two emails and a short response with Greg Perry regarding the EU provisions on data exclusivity. Jamie -------------- From: "Greg Perry" To: "James Love" Subject: Re: Health registration data Date: Thu, 27 Jan 2000 09:42:02 -0000 1. EU authorisation system Jamie, I explain various issues you raised below Authorisation of medical products can either go through: - The Centralised European system (obligatory for bio-tech product) or through - National registrations/Mutual Recognition Law on the exclusivity of clinical information is covered by the EU. However, in case of national authorisations Members States are given various options under the law as to how long a period of protection is given for national registrations. 2.Periods of exclusivity Products which received their authorisation through the European Centralised system receive a 10 year data exclusivity. Products which received their authorisation nationally will have data exclusivity periods according to the time frame option operated in the Member State. The protection period for each EU Member States is as follows: - 10 years in Belgium,Germany,France,Italy,the Netherlands,Sweden,UK - 6 years in Austria,Denmark, Finland,Ireland Luxembourg , - maximum 6 years but can not go beyond period of patent protection in Spain,Greece, Portugal, . - Iceland and Norway (EFTA countries) have also adopted 6 years. - New member scheduled for 2003 I.e. Poland, Hungary, Slovenia and Czech Republic are expected to opt for 6 years, Poland and Hungary are also expected to opt for 6 years but not beyond patent period.Hungary has also asked for transitional period of years after EU accession to implement law. 3. What is covered by Data Exclusivity It is important to note that under EU law, data exclusivity only relates to the NCE for which the first registration was made. Consequently, any new indications, dosage strength, or dosage form will not be covered by additional or new periods of data exclusivity. This was made clear in the so called "Generics case" of the European Court of Justice C 368/96 of December 3, 1998. Until this ruling certain Member States were "illegally" granting data exclusivity for new indications. There has been intense lobbying from EFPIA to change this law .They are demanding 10 years for all new indications, strengths and formulations. They claim that new indications are brought about by extensive trials and costs and should be protected. We argue that if they are "innovative" new uses they would be covered by a patent. Protection of innovation should be made by patent protection and not by data exclusivity.Clearly ,as in USA, the originator pharmaceutical industry is trying to have both patents and data exclusivity for protection. The EU Commission is now considering this issue and at TABD they indicated that they wanted to review the financial, competition, and health implications of such a change in the law to cover indications. The European Commission is also considering paediatric indications very seriously and may propose a 6 month-1 year exclusivity period to encourage companies to cover "children's needs". 4. Harmonisation There is also serious discussion to harmonise all data exclusivity provisions at national level. This is required for the proper function of the single market and the Mutual Recognition Procedure. EFPIA are calling for 10 years. We have called for 5 years and only covering NCEs. The Commission has floated the idea of 7-8 years and dropping the link to patent. However the 10 year period for Centralised Products will remain as part of this plan. There has also been low key talk of linking the introduction of data exclusivity for indications with a Bolar provision.Originator companies might accept this deal especially now that the WTO Panel has favoured Bolar provisions I.e. they see the writing on the whole and want to get something out it for themselves. All this talk of change falls within the so called "2001 Review" of Pharmaceutical legislation which has already begun. The idea is that by end of 2001 the European Union will be ready to update its pharmaceutical law so at be operative say by 2003/2004. 5 Paclitaxol The attempted registration of paclitaxol was made through the bibliographic procedure I.e. scientific literature based application. At the time the law was unclear as to the term "well established use" which was the term given it the type of product that could use such a system. As you know the Dutch authorities approved YEWTREE's product under this procedure but was challenged by BMS and the European Commission. The later argued that " well established" required at least 10 years on the market and made reference to the statements of a a judgement in ECJ case. I think you know the rest of the story... but in short the Law has just been amended to clearly indicate that "Well establish" means 10 years. As a result in Europe there is no clear avenue for getting "generic" versions of unpatented products made publicly available through scientific knowledge on the market . As you know the WHO has defined "Well established " as 5 years on the market . The EU is yet again out of line with rest of the world and using scientific language to provide excessive protection. 6. Withdrawal for the market You should also be aware of a new strategy being developed in the EU to prevent generic competition and parallel importing. Brand companies have started withdrawing their products/ revoking their licences just before patent expiry and replacing with a formation changed version of the product. in so doing they are claiming that a generic of the first version can not be placed on the market since there is no longer any brand reference product that the generic can make reference to! Worst still the national registration authorities and the EU Commission are agreeing to this!They are doing so because the way the EU law is written states that an abridged application must be made based on a product that has been authorised in the EU and "is marketed" in the Member State that the application is made". The EU Commission is seeking to have a guideline that will say that if the originator product was authorised at time of generic application that generic application can go ahead.However if generic applications are made after the revoking of the licence then the generic can not proceed. We are still pursuing this issue. I hope this is all of help. I wish you all the best in TACD and we are very lucky that some one like you on the consumer side takes such an interest inthese issues. Greg <------------------------------------------------------------------------> Date: Fri, 28 Jan 2000 05:47:00 -0500 (EST) To: e-drug@usa.healthnet.org From: Greg Perry Subject: [e-drug] TACD on Pharma Registration Data Exclusivity (cont'd) E-drug: TACD on Pharma Registration Data Exclusivity (cont'd) ------------------------------------------------------------------------- Jamie, Just one point: The 10 year data exclusivity period was indeed introduced to make up for a lack of patent protection though mainly for biotech products and not so much for lack of patent laws in Spain and Portugal. However, you are quite right to emphasise tht since EU national laws and TRIPs have provided for 20 year patents the arguments for such long data exclusivity should end. Indeed the EU has now adopted a Bio-tech patent and this should make the 10 year data exclusivity period unnecessary. This may be a very good point for you to push. Greg Greg Perry Director General European Generic Medicines Association (EGA) PO Box 193 Brussels 1040, Belgium Tel 32.2.7368411 Fax: 32 2 7367438 e mail: gperry@egagenerics.com web: www.egagenerics.com <----------------------------------------------------------------------> Date: Fri, 28 Jan 2000 09:50:20 -0500 (EST) To: e-drug@usa.healthnet.org From: James Love Subject: e-drug] TACD on Pharma Registration Data Exclusivity (cont'd) E-drug: TACD on Pharma Registration Data Exclusivity (cont'd) ------------------------------------------------------------------------- Greg, thanks for this information. When I visited with DGIII in 1998, I talked with them directly about data exclusivity issue, and they brought up the issue of patents in Spain and Portugal, and offered that as the main reason. However, I was not aware that there was a separate issue regarding biologics, and will add a discussion of this too. Jamie James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | love@cptech.org Voice 202/387-8030 | Fax 202/234-5176 -- James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | mailto:love@cptech.org Voice 1.202.387.8030 | fax 1.202.387.8030 From owner-pharm-policy@venice.essential.org Mon Jan 31 10:11:38 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id B985B21B02; Mon, 31 Jan 2000 10:11:37 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id KAA30803; Mon, 31 Jan 2000 10:11:37 -0500 Sender: jamie@genoa.essential.org Message-ID: <3895A633.B31384A8@cptech.org> Date: Mon, 31 Jan 2000 10:11:47 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: IP-Health list , pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Treatments low spread of AIDS This story seems to be important evidence that there should be more emphasis on treatment for HIV/AIDS in Africa Jamie http://www.nytimes.com/library/national/science/013100hth-aids-virus.html By THE ASSOCIATED PRESS AN FRANCISCO, Jan. 30 -- A study suggests that people with very low levels of H.I.V., the virus that causes AIDS, in their blood are unlikely to spread the virus to others. The study was conducted in Africa but could have important implications in the United States, where drug treatment has lowered virus levels for many AIDS patients. Health experts speculate that AIDS treatments may have an additional benefit -- slowing the epidemic by making infected people less likely to pass on the virus. [snip] The new study looked at sexual transmission of H.I.V. in rural Uganda. It was conducted by Dr. Thomas C. Quinn and others from Johns Hopkins University and presented today at the Seventh Conference on Retroviruses and Opportunistic Infections. The doctors followed 415 heterosexual couples in which one partner was infected with H.I.V. and one was not. Despite receiving free condoms, the couples rarely used them. During 30 months of follow up, 90 people in the study caught the virus. The study found that the higher the level of H.I.V. in the infected person's blood, the higher the risk of passing on the virus through sex. Counting the number of individual viruses in a milliliter of blood, the study found that someone with 200,000 viruses per milliliter was two and a half times more likely to spread H.I.V. than someone with 2,000 viruses per milliliter. But the researchers found no transmission of virus by infected people who carried less than 1,500 viruses per milliliter of blood, even if the people had sex without condoms. Because of the high expense, AIDS treatment is rare in Africa. [snip] -- James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | mailto:love@cptech.org Voice 1.202.387.8030 | fax 1.202.387.8030 From owner-pharm-policy@venice.essential.org Tue Feb 1 13:15:05 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 0DFCB21B06 for ; Tue, 1 Feb 2000 13:15:05 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id NAA23756 for ; Tue, 1 Feb 2000 13:15:05 -0500 Sender: jamie@genoa.essential.org Message-ID: <389722BE.9E9CF596@cptech.org> Date: Tue, 01 Feb 2000 13:15:26 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Michael Hirsh: Has the White House Really Changed Its Tune on AIDS Drugs?, This is forwarded as a fair use. Jamie --------------- http://newsweek.com/nw-srv/printed/us/na/a10740-2000feb1.htm Has the White House Really Changed Its Tune on AIDS Drugs?, Washington says it has shifted its policy on patents. But not everyone has gotten the message., By Michael Hirsh, With Gregory L. Vistica, Feb 01 2000 Newsweek.com: Newsweek US Edition: Nation: Has the White House Really Changed Its Tune on AIDS Drugs? It was with great fanfare that Bill Clinton announced a dramatic shift in America's policy on AIDS drugs at the World Trade Organization meeting in Seattle. The president, in one of several moves intended to appease raucous protesters, declared on Dec. 1 that Washington would no longer stand in the way of cheaper medicines for AIDS victims. Until then, the Clinton administration had mostly taken the side of major pharmaceutical manufacturers, which in order to preserve profits and royalties have sought to ban cheap knockoff drugs. But in Seattle, Clinton said that drug-patent rights were secondary, and "people in the poorest countries won't have to go without medicine they so desperately need." On Jan. 10, more than a month after Clinton's announcement, Vice President Al Gore reaffirmed the policy shift during a historic appearance before the U.N. Security Council, which convened to address AIDS in Africa. All well and good. So why in late January was the administration still pursuing its hardline policy of protecting corporate patents in Thailand, one of the worst-hit AIDS countries? A few days after Gore's U.N. appearance, on Jan. 14, an official with the U.S. Trade Representative's office warned the Thais that they could face trade sanctions if they issued a "compulsory license" to manufacture ddI, a drug like AZT that helps to fend off full-blown AIDS. Such a license would compel the U.S. pharmaceutical company that makes the drug, Bristol-Myers Squibb, to allow Thai or other overseas manufacturers to produce it themselves more cheaply. A key reason for Clinton's Seattle announcement was to facilitate that process. Again on Jan. 19, the U.S. embassy in Bangkok presented the Thais with a position paper that still emphasized U.S. disapproval of compulsory licensing. Such actions were typical before the administration's policy shift. AIDS activists complained that the administration applied the same unfeeling standard to defending U.S. intellectual property rights whether the issue was cassette tapes or life-and-death drugs. Yet in Thailand the U.S. actions were "particularly irritating," says James Love, head of the Consumer Project on Technology, a Ralph Nader-affiliated legal advocacy group. It wasn't just the obvious hypocrisy of announcing a policy shift in public and then ignoring it in practice, he says. Worse, ddI had actually been invented on a grant from the U.S. government, which itself held the patent. Bristol-Myers Squibb was trying to patent a formulation process for the drug in Thailand when it hadn't even been able to do so in the United States, Love says. (The company was not immediately available for comment.) It was only after the intervention of Leon Fuerth, Gore's national security advisor, that the Thai issue was resolved late last week, Newsweek has learned. Following a complaint from Love, Fuerth asked the U.S. Trade Representative's office to clearly state the new policy to the Thai government, according to an administration official familiar with the matter. The USTR's assistant trade representative for the issue, Joseph Papovich, finally responded with a letter on Jan. 27, which the U.S. ambassador to Thailand hand-delivered to the Thai Health minister. A copy was also faxed to the Commerce minister. "The United States will raise no objection," the letter said, if the Thai government decides that it needs to issue a compulsory license. Thai officials, who previously had said they would refrain from issuing a license because of U.S. pressure, are now reassessing what to do. Love says similar changes of approach have not yet been seen in other countries such as the Philippines and Dominican Republic. The U.S. trade representative's office did not respond to repeated requests for comment. Why have Clinton officials persisted in implementing the administration's old trade agenda of protecting the drug companies-after the president himself switched position? Some activists suggest Clinton's announcement was largely a matter of presidential politics. ACT-UP, an AIDS activist group, has repeatedly interrupted the vice president's campaign stops with "zaps," or well-orchestrated disturbances, focused on the drug licensing issue. These included the unfurling of a protest banner at Gore's kick-off announcement in July in Carthage, Tenn. But some activists believe that Gore and Clinton have genuinely come around on the issue. Love says the slowness to respond probably has more to do with the bureaucratic difficulties of altering a long-entrenched policy. When it comes to defending the intellectual property of U.S. companies, U.S. trade officials "have been fired up and [focused] on these countries for 15-to-20 years, and they have got great relationships with these companies," he says. Indeed, to persuade the trade representative's office, Fuerth had to argue that Thailand is a key ally of America's in Asia and that, as Gore outlined in his U.N. speech, the administration now sees the AIDS epidemic abroad as a national security issue. That's not just rhetoric. A new U.S. national intelligence estimate has found that that millions more people will die of AIDS-related deaths than official estimates have calculated, Newsweek has learned. The estimate, which is now classified but is scheduled to be released to the public within days, was prepared by the National Intelligence Council, a government body that draws officials from most of the federal intelligence agencies such as the CIA as well as from experts in the private sector. A U.S. government official who is familiar with the estimate said it concludes that, globally, 33.4 million people are infected with AIDS or HIV, the virus that causes the disease, with more than two-thirds of these cases in Sub-Saharan Africa. Previous predictions said that 1.7 million were expected to die by 2005. "We exceeded that last year with 2.5 million," says the government official. He says that there could be as many as 13.9 million deaths by 2008. "It's not slowing in the developing world," he said. "There is no money and they may never get it." Most of these will occur in Africa, but the estimate also concludes that the highest growth rate of infection is not in Africa, but in Asia and in India, Ukraine and Russia. By 2010, says this official, HIV infection in Asia will likely equal that of sub-Saharan Africa. Echoing Fuerth's view of AIDS as a national security issue in Africa as well as Asia, the official says, "the U.S. has equity in these countries. We look to South Africa and now Nigeria to bring stability to the region." He says the worst-case scenario in the new intelligence report is that "Aids is a catastrophe, unstoppable." But the final prediction is this: "We believe we're likely to see a worsening of the situation in the next ten years." After that, he says, education programs and other remedies, possibly including cheaper anti-AIDS drugs, will hopefully lead to a slowing of the disease. With Gregory L. Vistica -- James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | mailto:love@cptech.org Voice 1.202.387.8030 | fax 1.202.387.8030 From owner-pharm-policy@venice.essential.org Tue Feb 1 18:47:57 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id D163621AFF for ; Tue, 1 Feb 2000 18:47:57 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id SAA31886 for ; Tue, 1 Feb 2000 18:47:57 -0500 Sender: jamie@genoa.essential.org Message-ID: <389770C6.B6C904E2@cptech.org> Date: Tue, 01 Feb 2000 18:48:22 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Michael Hirsh's Newsweek.com story Michael Hirsh's Newsweek.com story was updated to include a quote from Patrick Donahue from BMS and Sean Murphy from USTR, included in the paragraph below: ----------- Most big drug corporations fear that a compulsory license for any AIDS drug would open a Pandora's box, setting a precedent for other drugs and robbing the companies of royalties. "You're looking at the possibility that a compulsory license could impede research," says company spokesman Patrick Donahue. U.S. trade official Murphy, meanwhile, says he intended no threat of sanctions to Thai officials. But he concedes that the government was concerned that in Thailand compulsory licensing "was the only option being looked at." Asked whether he also reminded the Thais that the president had announced a new policy on AIDS drugs, Murphy said only that he "may have alluded to it Jamie -- James Love, Consumer Project on Technology P.O. Box 19367 | http://www.cptech.org Washington, DC 20036 | mailto:love@cptech.org Voice 1.202.387.8030 | fax 1.202.387.8030 From owner-pharm-policy@venice.essential.org Wed Feb 2 10:39:31 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id CB28721AFF for ; Wed, 2 Feb 2000 10:39:31 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id KAA09032 for ; Wed, 2 Feb 2000 10:39:31 -0500 Sender: jamie@genoa.essential.org Message-ID: <38984FD3.F92C11E7@cptech.org> Date: Wed, 02 Feb 2000 10:40:03 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Stephens and Strauss: CDC misled Congress on spending Why is it so hard to get the Cinton administration to provide buget data on its investments in drug development? One explanation, according to this Washington Post article, is that agencies lie to congress about how they spend money. http://www.washingtonpost.com/wp-dyn/articles/A60473-2000Feb1.html CDC Misled Congress on Spending, Records Show By Joe Stephens and Valerie Strauss Washington Post Staff Writers Wednesday, February 2, 2000; Page A1 Seven years ago a long-distance runner from New Mexico caught cold, struggled for breath as liquid flooded her lungs, then suddenly died. Her fiance died five days later, followed by more than two dozen other residents of the American Southwest. The federal Centers for Disease Control and Prevention identified the killer as a previously unknown strain of hantavirus, a mouse-borne disease with a staggering mortality rate. An alarmed Congress responded by giving the CDC up to $7.5 million a year to fight it. At least, Congress thought it did. [snip] ======================================================= James Love, Director | http://www.cptech.org Consumer Project on Technology | mailto:love@cptech.org P.O. Box 19367 | voice: 1.202.387.8030 Washington, DC 20036 | fax: 1.202.234.5176 ======================================================= From owner-pharm-policy@venice.essential.org Wed Feb 2 11:38:00 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 980A421B08 for ; Wed, 2 Feb 2000 11:38:00 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id LAA10345 for ; Wed, 2 Feb 2000 11:38:00 -0500 Sender: jamie@genoa.essential.org Message-ID: <38985D88.A05B0CEE@cptech.org> Date: Wed, 02 Feb 2000 11:38:32 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Bangkok Post: Compulsory ddI licensing seen unlikely Forwarded from healthgap list. A Thai Government official, Dr. Somsong Rukphao, is quoted as saying the US government letter to the NGO group is a "a diplomatic way of answering such issues", and he is further quoted as saying he does not believe issuance of a compulsory license will *not* result in trade sanctions. I guess years of trade pressures were not easily reverse by the NGO letter. I think we have to go back and tell the Clinton/Gore administration that it is time to actually support the issuance of a CL for ddI in Thailand, and stop beating around the bush. How many more years will this take? Jamie ---------------------- Subject: Compulsory ddI licensing seen unlikely Date: Wed, 2 Feb 2000 11:18:31 -0500 (EST) From: richard@atdn.org (Richard Jefferys) To: Multiple recipients of list Bad news from Thailand? Several other new articles have also been added to the Health GAP Coalition website at www.healthgap.org http://www.bangkokpost.com/today/020200_News14.html February 2, 2000 HIV / AIDS Compulsory ddI licensing seen unlikely Ministries prefer to negotiate drug price Aphaluck Bhatiasevi and Woranuj Maneerungsee The Ministry of Public Health yesterday insisted it will not opt for compulsory licensing of the Aids drug didanosine (ddI) because it is uncertain about the effect this could have on international trade agreements. Somsong Rukphao, head of the ministry's communicable diseases control department, said the ministry is firm about enabling people with HIV/Aids to get maximum access to necessary drugs, but would opt for negotiations rather than enforcing compulsory licensing. Dr Somsong said he remains unconvinced enforcement of compulsory licensing under the Thai patent law will not result in trade sanctions. He said a letter sent recently by the US trade representative to Paisal Tan-ud, chairman of the Network of People with HIV/Aids in Thailand, was merely "a diplomatic way of answering such issues". "It is natural for them to say that they won't interfere with our internal law enforcement procedures provided it does not violate international trade agreements," he said. In his reply to Mr Paisal, assistant US trade representative Joseph S. Papovich said the United States will not raise objections if the Thai government is determined to issue compulsory licensing to address its health care crisis, provided it complies with the World Trade Agreement on Intellectual Property Rights (Trips). Both the public health and commerce ministries are still to officially react to the USTR's letter. Senior officials of both ministries remain uncommitted, saying they are still to see a copy of the letter. The officials also expressed great caution in pursuing the issue for fear of US retaliation. Ddi, produced by the US-based pharmaceutical giant Brystol-Myers Squibb, is sold at 41 baht a tablet, a price which the HIV/Aids network claims the majority of patients cannot afford. The Commerce Ministry's intellectual property rights department is yet to reply to a Jan 17 enquiry from the Health Ministry on the possibility of compulsory licensing according to Article 51 of the intellectual property rights laws of the World Trade Organisation (WTO), which permits compulsory licensing of products which will benefit the masses. "It is clear the Commerce Ministry is against enforcing compulsory licensing," said a senior commerce official who requested anonimity. He said Bristol-Myers Squibb is not expected to give in without a fight and that even though Thailand can count on backing from other developing countries which have a serious Aids situation, the company and the US government are likely to defend themselves even more strongly. "They don't want the ddI case in Thailand to set a precedent for other countries to follow," the official said. Goanpot Assavinvichit, the deputy commerce minister, told reporters earlier that talks on a compromise should be initiated, as this could possibly result in bringing down the price per tablet of ddI from 41 baht to 31 baht. Aids activist Jon Ungphakorn said the NGOs and the Network of People with HIV/Aids will continue to push for compulsory licensing of the drug. He said the NGOs and HIV/Aids network feel that the Health Ministry's decision to opt for production of powdered form of ddI will not result in the drug being accessible to the larger portion of people with HIV. For the Government Pharmaceutical Organisation to be able to manufacture the drug in powder form-as stated by Health Minister Korn Dabbaransi-at a cheap price, the ministry will have to acquire the drug in bulk quantities, Mr Jon said. He said it is unlikely that the ministry will purchase from the state-run drug manufacturing plant, as Bristol-Myers Squibb, the patent holder of ddI, has already said it is willing to sell the drug to the ministry at a cheaper price. ---------------------------- AIDS Treatment Data Network 611 Broadway, Suite #613 New York, NY 10012 Tel: (800) 734-7104 Fax: (212) 260-8869 E-mail: network@atdn.org Internet: aidsinfonyc.org/network -- ======================================================= James Love, Director | http://www.cptech.org Consumer Project on Technology | mailto:love@cptech.org P.O. Box 19367 | voice: 1.202.387.8030 Washington, DC 20036 | fax: 1.202.234.5176 ======================================================= From owner-pharm-policy@venice.essential.org Wed Feb 2 11:55:09 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 5AA9221BC0 for ; Wed, 2 Feb 2000 11:55:09 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id LAA10727 for ; Wed, 2 Feb 2000 11:55:09 -0500 Sender: jamie@genoa.essential.org Message-ID: <3898618D.C62F51C1@cptech.org> Date: Wed, 02 Feb 2000 11:55:41 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] National Academies Workshop - starts today http://www4.nationalacademies.org/pd/step.nsf/8525648b0070c170852562cb0073ff22/371702b9c0c250a38525674d0061f3a6?OpenDocument BOARD ON SCIENCE, TECHNOLOGY, AND ECONOMIC POLICY Intellectual Property Rights in a Knowledge-Based Economy The STEP Board announces a 2-day conference, Intellectual Property Rights: How Far Should They Be Extended? in the Lecture Room of the National Academy of Sciences, Washington, DC on Wednesday, February 2 and Thursday, February 3, 2000. The conference will bring together economists, legal scholars, inventors, corporate representatives, legal practitioners, members of the Federal branch, and policymakers to begin to assess the benefits and costs of national policy which, for two decades with few exceptions, has been to extend patent, copyright and trade secret protection. Registration is free. Below is the program: Intellectual Property Rights: How Far Should They Be Extended? Wednesday, February 2, 2000 & Thursday, February 3, 2000 Auditorium National Academy of Sciences 2100 C Street, N.W. Washington, DC Wednesday, February 2, 2000 8:30 a.m. Welcome Richard Levin, President, Yale University Mark Myers, Senior VP, Xerox Corporation 8:45 a.m. Keynote Remarks Hon. Q. Todd Dickinson, U.S. Patent and Trademark Office 9:15 a.m. Issues for Consideration F.M. Scherer, Kennedy School of Government, Harvard University Robert Merges, Boalt Hall Law School, University of California, Berkeley 10:00 a.m. IPRs in Semiconductors Bronwyn Hall, University of California, Berkeley Rosemarie Ziedonis, Wharton School, University of Pennsylvania Discussants: James Rose, formerly of Altera Richard Ehrlickman, IBM Microelectronics 11:00 a.m. IP Protection, Technology Development, and Competition Timothy Bresnahan, U.S. Department of Justice, Chair Richard Gilbert, University of California, Berkeley Susan Desanti, Federal Trade Commission Suzanne Scotchmer, University of California, Berkeley Don Kash, George Mason University 12:30 p.m. Lunch 1:30 p.m. IPRs in Software & Business Methods David Mowery, University of California, Berkeley Greg Aharonian, Internet Patent News Service Discussants: Martin Konopken, Autodesk Jeff Brandt, Walker Digital Corporation 2:30 p.m. Patent Quality, Scope, and Suitability Hon. Roderick R. McKelvie, U.S. District Court for the District of Delaware, Chair John Thomas, George Washington University National Law Center Pam Samuelson, University of California, Berkeley Cecil Quillen, Jr., PHB Hagler Bailly, Inc. Brian Kahin, Internet Policy Institute 4:00 p.m. Patent Administration and Litigation Hon. Fern Smith, Federal Judicial Center and U.S. District Court for the Northern District of California, Chair Jean Lanjouw, Yale University Joshua Lerner, Harvard Business School Kevin Baer, U.S. Patent and Trademark Office 6:00 pm Reception and Dinner, Great Hall, National Academy of Sciences Thursday, February 3, 2000 8:30 a.m. Welcome Dale Jorgenson, Harvard University, STEP Board Chair 8:40 a.m. Opening Remarks Hon. Randall Rader, U.S. Court of Appeals for the Federal Circuit 9:15 a.m. IPRs in Biotechnology: Pharmaceutical and Agricultural Applications Iain Cockburn, Boston University Brian Wright, University of California, Berkeley Discussants: Eric Larson,Pfizer, Inc. Lee Bendekgey, Incyte Michael Roth, Monsanto 10:30 a.m. IP Rights to Tools and Results of Fundamental Research Michael Morgan, Wellcome Trust Genome Campus, Chair John Barton, Stanford University Law School Robert Blackburn, Chiron Corporation Boro Dropulic, Virxsys Corporation Elke Jordan, National Human Genome Research Institute Evelyn McConathy, Dilworth Paxson, LLP 12:00 pm Lunch 1:00 p.m. IP Protection and Knowledge Transfers Wesley Cohen, Carnegie Mellon University James Pooley, Gray Cary Ware & Friedenrich, LLP Alfonso Gambardella, University of Urbino 2:30 p.m. Summary and Discussion Richard Levin and Mark Myers, Chairs John Barton, Stanford University Law School Mark Myers, Xerox Corporation 3:30 p.m. Adjourn -- ======================================================= James Love, Director | http://www.cptech.org Consumer Project on Technology | mailto:love@cptech.org P.O. Box 19367 | voice: 1.202.387.8030 Washington, DC 20036 | fax: 1.202.234.5176 ======================================================= From owner-pharm-policy@venice.essential.org Wed Feb 2 15:46:45 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 755E521AFF for ; Wed, 2 Feb 2000 15:46:45 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id PAA16182 for ; Wed, 2 Feb 2000 15:46:45 -0500 Sender: jamie@genoa.essential.org Message-ID: <389897D7.6AD891F2@cptech.org> Date: Wed, 02 Feb 2000 15:47:19 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] 3 more Thai articles http://www.nationgroup.com/nation/Mon/head2.html Profs make plea to Barshefsky over 'false report' BY MUKDAWAN SAKBOON The Nation January 31, 2000 http://www.bangkokpost.net/290100/290100_News03.html Global focus on access to drug US trade monitor to step aside on issue Woranuj Maneerungsee, Nusara Thaitawat and Aphaluck Bhatia January 29, 2000 http://www.nationgroup.com/nation/Sat/p2960.html Green light given for anti-Aids drug licensing BY Mukdawan Sakboon The Nation January 29, 2000 -- ======================================================= James Love, Director | http://www.cptech.org Consumer Project on Technology | mailto:love@cptech.org P.O. Box 19367 | voice: 1.202.387.8030 Washington, DC 20036 | fax: 1.202.234.5176 ======================================================= From owner-pharm-policy@venice.essential.org Thu Feb 3 17:45:57 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id DD9B521B16 for ; Thu, 3 Feb 2000 17:45:56 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id RAA06350 for ; Thu, 3 Feb 2000 17:45:56 -0500 Sender: jamie@genoa.essential.org Message-ID: <389A0552.B179AA85@cptech.org> Date: Thu, 03 Feb 2000 17:46:42 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Allocation of R&D costs, the 1991 DiMasi study The following are numbers from Joe DiMasi, et. all's 1991 paper on drug development costs. (DiMasi, Hansen, Grabowski and Lasagna, "Cost of Innovation in the pharmacuetical industry," Journal of Health Economics 10 (1991)). This is the most famous of all cost studies, and the one that nearly everyone uses as a basis for cost estimates. Joe has kindly looked at this note already. In Table 5 of his paper, Joe and his co-authors presented sensitivity analysis of the costs of developoing a drug, using different assumptions regarding the costs of capital. Joe DiMasi's 1991 paper, using 1987 dollars Table 5, using .23 success with with with Capital Capital Capital out of pocket Costs Costs Costs per approval @ 5% @ 9% @ 15% ------------ ------------ ------------ ----------- Preclinical 66 57.9% 107 63.3% 156 67.5% 269 72.7% Clincial 48 42.1% 62 36.7% 75 32.5% 101 27.3% Total 114 100.0% 169 100.0% 231 100.0% 370 100.0% Given some technical issues that Joe and I are talking about, I am not getting into the (Phase I, II and III, before and after risk adjustement) detail of of clinical expenses. Only the "per approval" numbers are reported for pocket expenses. This is a risk adjusted number, that takes account of failures. The risk adjusted out of pocket costs for cinical trials were $48 million, and the risk adjusted pre-clinical expenditures were $66 million. Joe assumed 9 percent was the cost of capital, so the $231 million total was quoted by people for a while, until OTA updated his numbers in 1990 dollars, and looked at different capital costs, for sensitivity analysis. Note that Joe estimated that 58 percent of all out pocket (per- approved drug) costs were for the pre-clinical phase, and when capital costs were assumed to be 9 or 15 percent, the pre-clinical share is even larger: 68 to 73 percent. Joe's figures only apply to "self originated" drugs, and not to drugs licensed from a University or government. One point to keep in mind, is that if Yale licenses d4T to BMS, most if not all of the pre-clinical work is paid for already (often by the US government). Joe suggested I present these in 1998 dollars, using an inflation factor of 35.6 percent: In 1998 dollars: with with with Capital Capital Capital out of pocket Costs Costs Costs per approval @ 5% @ 9% @ 15% ------------ ------------ ------------ ------------ Preclinical 89 57.9% 145 63.3% 212 67.5% 365 72.7% Clincial 65 42.1% 84 36.7% 102 32.5% 137 27.3% Total 155 100.0% 229 100.0% 313 100.0% 502 100.0% Next, I wanted to present the capital costs as a separate item from the per approval out of pocket expenses. (This is the total cost from above, minus the out of pocket expenses). As indicated below, capital costs (the profits you need to justify the investments), are 51 percent with a 9 percent real return is assumed, and 69 percent of the total when a 15 percent real return is assumed. out of pocket and capital costs compared 1998 dollars, captial costs at 9 percent out of Capital out of Capital pocket Costs pocket Costs p/app @9% total p/app @9% total ----------------------- --------------------- Preclinical 89 122 211 28% 39% 67% Clincial 65 37 102 21% 12% 32% Total 155 159 314 49% 51% 100% out of pocket and capital costs compared 1998 dollars, 15 percent capital costs out of Capital out of Capital pocket Costs pocket Costs p/app @9% total p/app @9% total ----------------------- ---------------------- Preclinical 89 276 365 18% 55% 73% Clincial 65 72 137 13% 14% 27% Total 155 347 502 31% 69% 100% Finally, here are a few interesting facts on the out of pocket cost numbers. DiMasi's 1987 unweighted average cost for clinical trials, for drugs that were approved by the FDA. (Before risk adjustments). $28 million The 1987 clincial trial costs, after risk adjustments: $48 million The risk adjusted (per approval) private sector expenditures on clincial trials, for Orphan Drugs, based upon the IRS data, nominal data, for 1983 to 1993: $2.3 million. There are, of course, a lot of different issues that one might raise in these studies, and I'll address some of these later, such as assumptions regarding the time to NDA. Jamie -- ======================================================= James Love, Director | http://www.cptech.org Consumer Project on Technology | mailto:love@cptech.org P.O. Box 19367 | voice: 1.202.387.8030 Washington, DC 20036 | fax: 1.202.234.5176 ======================================================= From owner-pharm-policy@venice.essential.org Thu Feb 3 18:02:45 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 82EF521AFF for ; Thu, 3 Feb 2000 18:02:45 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id SAA06658 for ; Thu, 3 Feb 2000 18:02:45 -0500 Sender: jamie@genoa.essential.org Message-ID: <389A0942.66139B49@cptech.org> Date: Thu, 03 Feb 2000 18:03:31 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] fixed: Allocation of R&D costs, the 1991 DiMasi study This is a spell checked version! Jamie -------------- The following are numbers from Joe DiMasi, et. all's 1991 paper on drug development costs. (DiMasi, Hansen, Grabowski and Lasagna, "Cost of Innovation in the pharmaceutical industry," Journal of Health Economics 10 (1991)). This is the most famous of all cost studies, and the one that nearly everyone uses as a basis for cost estimates. Joe has kindly looked at this note already. In Table 5 of his paper, Joe and his co-authors presented sensitivity analysis of the costs of developing a drug, using different assumptions regarding the costs of capital. Joe DiMasi's 1991 paper, using 1987 dollars Table 5, using .23 success with with with Capital Capital Capital out of pocket Costs Costs Costs per approval @ 5% @ 9% @ 15% ------------ ------------ ------------ ----------- Preclinical 66 57.9% 107 63.3% 156 67.5% 269 72.7% Clinical 48 42.1% 62 36.7% 75 32.5% 101 27.3% Total 114 100.0% 169 100.0% 231 100.0% 370 100.0% Given some technical issues that Joe and I are talking about, I am not getting into the (Phase I, II and III, before and after risk adjustment) detail of of clinical expenses. Only the "per approval" numbers are reported for pocket expenses. This is a risk adjusted number, that takes account of failures. The risk adjusted out of pocket costs for clinical trials were $48 million, and the risk adjusted pre-clinical expenditures were $66 million. Joe assumed 9 percent was the cost of capital, so the $231 million total was quoted by people for a while, until OTA updated his numbers in 1990 dollars, and looked at different capital costs, for sensitivity analysis. Note that Joe estimated that 58 percent of all out pocket (per- approved drug) costs were for the pre-clinical phase, and when capital costs were assumed to be 9 or 15 percent, the pre-clinical share is even larger: 68 to 73 percent. Joe's figures only apply to "self originated" drugs, and not to drugs licensed from a University or government. One point to keep in mind, is that if Yale licenses d4T to BMS, most if not all of the pre-clinical work is paid for already (often by the US government). Joe suggested I present these in 1998 dollars, using an inflation factor of 35.6 percent: In 1998 dollars: with with with Capital Capital Capital out of pocket Costs Costs Costs per approval @ 5% @ 9% @ 15% ------------ ------------ ------------ ------------ Preclinical 89 57.9% 145 63.3% 212 67.5% 365 72.7% Clinical 65 42.1% 84 36.7% 102 32.5% 137 27.3% Total 155 100.0% 229 100.0% 313 100.0% 502 100.0% Next, I wanted to present the capital costs as a separate item from the per approval out of pocket expenses. (This is the total cost from above, minus the out of pocket expenses). As indicated below, capital costs (the profits you need to justify the investments), are 51 percent with a 9 percent real return is assumed, and 69 percent of the total when a 15 percent real return is assumed. out of pocket and capital costs compared 1998 dollars, capital costs at 9 percent out of Capital out of Capital pocket Costs pocket Costs p/app @9% total p/app @9% total --------------------- -------------------- Preclinical 89 122 212 28% 39% 67% Clinical 65 37 102 21% 12% 32% Total 155 159 313 49% 51% 100% out of pocket and capital costs compared 1998 dollars, 15 percent capital costs out of Capital out of Capital pocket Costs pocket Costs p/app @15% total p/app @15% total ----------------------- -------------------- Preclinical 89 276 365 18% 55% 73% Clinical 65 72 137 13% 14% 27% Total 155 347 502 31% 69% 100% Finally, here are a few interesting facts on the out of pocket cost numbers. DiMasi's 1987 unweighted average cost for clinical trials, for drugs that were approved by the FDA. (Before risk adjustments). $28 million The 1987 clinical trial costs, after risk adjustments: $48 million The risk adjusted (per approval) private sector expenditures on clinical trials, for Orphan Drugs, based upon the IRS data, nominal data, for 1983 to 1993: $2.3 million. There are, of course, a lot of different issues that one might raise in these studies, and I'll address some of these later, such as assumptions regarding the time to NDA. Jamie -- ======================================================= James Love, Director | http://www.cptech.org Consumer Project on Technology | mailto:love@cptech.org P.O. Box 19367 | voice: 1.202.387.8030 Washington, DC 20036 | fax: 1.202.234.5176 ======================================================= From owner-pharm-policy@venice.essential.org Fri Feb 4 14:06:13 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id E03BE21AFF; Fri, 4 Feb 2000 14:06:12 -0500 (EST) Received: from cptech.org (fluid.essential.org [216.0.124.57]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id OAA21858; Fri, 4 Feb 2000 14:06:08 -0500 Sender: tb@genoa.essential.org Message-ID: <389B23E5.EAC5BBAF@cptech.org> Date: Fri, 04 Feb 2000 14:09:25 -0500 From: Thiru Balasubramaniam Organization: Consumer Project on Technology X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: Multiple recipients of list , Multiple recipients of list IP-HEALTH , Multiple recipients of list PHARM-POLICY Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Dominican IPR legislation (compulsory licensing sections) Proposed Dominican Republic legislation on Industrial Property The USPTO provided Consumer Project on Technology this December 1999 English translation of the proposed Dominican Republic legislation on Industrial Property. These are the sections pertaining to compulsory licensing. http://www.cptech.org/ip/health/domrep/driprdec99.html -------------------------------------------------------begin ----------- SECTION IV OBLIGATORY LICENSES AND OTHER MEASURES RELATED TO THE EXPLOITATION OF PATENTS Article 347.- Exploitation of the Patent For the effects of Article 349 of this law, exploitation of a patent is understood as follows: a) When the patent has been granted for a product or for a procedure for the obtaining of a product, supply to the internal market in reasonable quantity, quality and price, through production in this country and importation. b) When the patent has been granted for a procedure not included in subparagraph a), the use of the procedure on a commercial scale in this country. Article 348: Obligatory Licenses 348.1 When a potential user has attempted to obtain the granting of a license from the patent. holder under reasonable--commercial terms and conditions and such attempts have not been effective after a period of one hundred eighty (180) days, counted from the date on which the respective license was applied for, the General Agency for Industrial Property, after prior hearing of the holder, shall issue obligatory licenses relating to that patent. 348.2 To determine what is understood by reasonable commercial terms and conditions, the particular circumstances of each case and the economic value of the authorization must be taken into account, keeping in mind the average rate of royalties for the sector in question in contracts for commercial licenses between independent parties. Article 349.- Obligatory License for Lack of Exploitation 349.1 After three (3) years from the granting of the patent, or four (4) years from the filing of the application, applying whichever term expires later, if the invention has not been exploited or when the exploitation of the same has been interrupted for more than one (1) year without justifiable cause, any person with the ability to exploit the invention may apply to the General Agency for Industrial Property to grant him or her an obligatory license for the patent in question. 349.2 An obligatory license shall not be granted when it is demonstrated that the lack or insufficiency of exploitation is due to fortuitous circumstances or force majeure, or to circumstances beyond the will or control of the patent holder and which justify the lack or insufficiency of exploitation. The lack of economic resources and the lack of economic viability of the exploitation are not considered justifying circumstances. Article 350.- Obligatory Licenses for Anti-competitive Practices 350.1 Obligatory licenses shall be granted when the General Agency for Industrial Property has determined that the patent holder has indulged in anti-competitive practices. In such cases, without prejudice to the appeals available to the patent holder, the concession shall be carried out without the need to apply the procedure set forth in subparagraph c) of Article 352. 350.2 For the purposes of this law, the following practices, among others, are considered to be anti-competitive: a) Setting excessive or discriminatory prices for the patented products. In particular, when there are offers of supply to the market at prices significantly lower than those offered by the patent holder for the same product. b) Failure to supply the market under reasonable commercial conditions. c) Hindrance of commercial or productive activities d) The other actions set forth as such by this code and every other action, which national legislation typifies as anti-competitive, limiting or restrictive to competition. Article 351: Application for and Granting of Obligatory Licenses 351.1 Any person interested in obtaining an obligatory license must apply for it to the General Agency for Industrial Property. The application must indicate the conditions under which he or she intends to obtain the obligatory license. 351.2 The person applying for an obligatory license must confirm that he or she has previously requested a contractual license from the patent holder, and has not been able to obtain it under the conditions and within the time limits set forth in Article 348. It shall not be necessary to fulfill this requirement in cases of national emergency or extreme urgency, or cases of a commercial use of the invention by a public agency. In such cases the patent holder shall be informed without delay of the granting of the license. Nor shall it be necessary to fulfill that requirement when the purpose of the license is to remedy an anti-competitive practice. 351.3 Without prejudice to that which is set forth in Article 351.2, the General Agency for Industrial Property shall notify the patent holder of an application for obligatory license within a period of thirty (30) days, counted as of day of the filing of the application. 351.4 The patent holder must present his statements and arguments within a time limit no more than sixty (60) days, counted from the date of notification of the application for an obligatory license. If this time limit passes without the holder having expressed himself, the conditions presented by the applicant shall be considered as accepted. 351.5 In case the holder responds, the General Agency for Industrial Property, after first hearing the parties and if they should not come to agreement, shall set a reasonable remuneration which the patent holder shall receive, which shall be established according to Article 348. 351.6 The decisions with reference to the granting of these uses must be adopted within one hundred twenty (120) days from the filing of the application and the same shall be appealable. The substantiation of the appeal shall not have the effect of suspension. Article 352.- Conditions for the Granting of Obligatory Licenses 352.1 To grant obligatory licenses, the following provisions must be observed: a) The granting of same must be by the General Agency for Industrial Property. b) The circumstances of each case shall be considered. c) The obligatory licenses shall be extended to patents relating to the components and processes permitting their exploitation d) The granting of these licenses shall not be exclusive. e) They may not be assigned, except for that part of the company or of its intangible asset that forms part of it. f) They shall be granted principally to supply the internal market, except in the cases established in Articles 349 and 354. g) The patent holder shall receive a reasonable remuneration, according to the circumstances of each case, taking into account the economic value of the authorization. In determining the amount of the remuneration in cases in which the obligatory licenses have been granted to remedy anti-competitive practices, the necessity of correcting such practices shall be taken into account and the revocation of the grant may be denied if it is considered probable that the conditions that caused that granting have been repeated. 352.2 The person to whom the obligatory license is granted must begin its exploitation within two years of the granting of the license to him. 352.3 When the patent protects any semiconductor technology, obligatory licenses shall be granted only for non-commercial public use, or to rectify a practice declared to be contrary to competition. 352.4 An obligatory license may be completely or partially revoked by the court created by this Code, upon request by the holder, if the circumstances that gave rise to the license have ceased to exist and it is improbable that they will again arise, so long as such revocation does not affect the legitimate interests of the licensee. 352.5 An obligatory license can be modified by the court created by this Code, upon application by an interested party, when so justified by new facts or circumstances. Article 353: Obligatory License in the Case of Dependent Patents 353.1 When an invention claimed in a subsequent patent cannot be exploited in this country without infringing an earlier patent, the General Agency for Industrial Property, upon the request of the holder of the first mentioned patent or of his licensee, or of the beneficiary of an obligatory license for that patent, may grant an obligatory license with regard to the earlier patent insofar as may be necessary to avoid the infringement. 353.2 The obligatory license shall be granted only when the invention claimed in the subsequent patent implies an important technical advance of considerable economic significance with regard to the invention claimed in the earlier patent. 353.3 When an obligatory license is granted in conformity with Article 353.1, an obligatory license may be granted in the same circumstances with regard to the later patent, if the holder of the earlier patent, his licensee or the beneficiary of an obligatory license for said earlier patent applies for it. 353.4 An obligatory license of those set forth in this article cannot be granted as exclusive. This obligatory license can only be the object of transfer simultaneously with the dependent patent the industrial exploitation of which requires the license. The transfer of the obligatory license shall be subject to the provisions of Article 340.2, insofar as is appropriate. 353.5 The provisions of Articles 351 and 35L insofar as they are appropriate, are applicable to the licenses set forth in this article. Article 354: Public Interest Licenses For reasons of public interest, and in particular for reasons of emergency or national security declared by the Executive Power, the General Agency for Industrial Property, at the request of any interested person or competent authority, or on its own initiative, shall at any time order the following: a) that an invention which is the object of a patent or patent application being processed be exploited by a government agency or by one or more public or private persons designated for the purpose. b) that an invention that is the object of a patent or of a patent application being processed be open for the granting of licenses in the public interest, in which case the General Agency for Industrial Property. shall grant a license for exploitation to any person who applies for it and has the ability to carry out such exploitation in this country. Article 355: Conditions for Public Interest Licenses 355.1 Every public interest license implies the corresponding payment to the patent holder. After prior hearing of the parties, and in the absence of an agreement, the amount and method of payment shall be set by the General Agency for Industrial Property. 355.2 A public interest license can refer to the execution of any of the actions referred to in Article 337.1 355.3 The provisions of Articles 351 and 352, insofar as appropriate, are applicable to the granting of public interest licenses. 355.4 The granting of an obligatory license by reason of public interest shall not diminish the right of the patent holder to continue exploiting it. Article 356: Revocation of the Patent in Case of Abuse 356.1 At the request of any interested person or of any competent authority, the General Agency for Industrial Property can revoke a patent when the rights conferred by the patent are abused with regard to anti-competitive practices or abuse of a dominant market position in such a way that the national economy is unduly affected. 356.2 The request for revocation may not be presented until two years have passed counting from the date of granting of the first obligatory license. From owner-pharm-policy@venice.essential.org Fri Feb 4 15:16:59 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id AAAC621AFF; Fri, 4 Feb 2000 15:16:59 -0500 (EST) Received: from cptech.org (fluid.essential.org [216.0.124.57]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id PAA23370; Fri, 4 Feb 2000 15:16:58 -0500 Sender: tb@genoa.essential.org Message-ID: <389B347E.8912DF5A@cptech.org> Date: Fri, 04 Feb 2000 15:20:14 -0500 From: Thiru Balasubramaniam Organization: Consumer Project on Technology X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: Multiple recipients of list , Multiple recipients of list IP-HEALTH , Multiple recipients of list PHARM-POLICY Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Salon interview with Dr. Ian Roberts Today's Salon magazine features an interview with Dr. Ian Roberts, special advisor to the South African Minister of Health. http://www.salon.com/health/feature/2000/02/04/african_aids/index.html From owner-pharm-policy@venice.essential.org Sun Feb 6 12:29:35 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from correo.javeriana.edu.co (correo.javeriana.edu.co [200.3.154.15]) by venice.essential.org (Postfix) with ESMTP id C41E821AFF for ; Sun, 6 Feb 2000 12:29:33 -0500 (EST) Received: from webmail ([172.25.0.5]) by correo.javeriana.edu.co (Netscape Messaging Server 3.6) with SMTP id AAA479E for ; Sun, 6 Feb 2000 13:33:31 -0500 From: "RICARDO JULIAN ROJAS ESTUPINAN" To: pharm-policy@venice.essential.org X-Mailer: Netscape Messenger Express 3.5.2 [Mozilla/4.0 (compatible; MSIE 4.01; Windows 95)] Date: Sun, 6 Feb 2000 13:33:31 -0500 Message-ID: <7735E48AD03.AAA479E@correo.javeriana.edu.co> Subject: [Pharm-policy] (no subject) unsuscribe me pharm policy From owner-pharm-policy@venice.essential.org Mon Feb 7 09:31:31 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 4417221AFF for ; Mon, 7 Feb 2000 09:31:31 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id JAA21987 for ; Mon, 7 Feb 2000 09:31:31 -0500 Sender: jamie@genoa.essential.org Message-ID: <389ED797.5BD82822@cptech.org> Date: Mon, 07 Feb 2000 09:32:55 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] BMS says it will sue in Thailand over generic production of d4T This is a note from MSF on BMS's threat of litigation over Thai production of d4T, a drug first synthesized by NIH, and later patented in the US in some countries (but not Thailand) by Yale for "use" on HIV/AIDS. Jamie --------------------- Subject: BMS threatening with law suit Date: Mon, 7 Feb 2000 10:57:25 +0700 From: "MSF-Drugs Bangkok" To: "James Love" BMS is threatening with a law suit if d4T will be produced by the Thai GPO! BMS claims that it has a right to five years of exclusivity although it voluntary withdrew the drug earlier from the SMP (Safety Monitoring Program), the mechanism that was set up to give this exclusivity. d4T was patented by Yale University in the US in 1990; there is no patent for d4T in Thailand. It was discussed earlier on this list that the exclusivity protection that is granted in Thailand does not fall under the TRIPS transition rules because Thailand already provided for product patents since 1992. Tido From owner-pharm-policy@venice.essential.org Mon Feb 7 09:57:25 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id B007221AFF for ; Mon, 7 Feb 2000 09:57:25 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id JAA22378 for ; Mon, 7 Feb 2000 09:57:25 -0500 Sender: jamie@genoa.essential.org Message-ID: <389EDDAA.D6EAE6BE@cptech.org> Date: Mon, 07 Feb 2000 09:58:50 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Blue Book URL It is pretty hard to find, but here is the URL for the WHO "Blue Book," Globalization and Access to Drugs (Previously the "Red Book") http://www.who.int/medicines/docs/Pagespublications/Economicspub.htm There are a few other interesting books on this page too. My major complaint is that WHO will not put this on the web in HTML format. It is in Microsoft Word 97 format (not even the generic rtf format). We have asked WHO to put it in HTML, but it hasn't happened yet. Jamie ======================================================= James Love, Director | http://www.cptech.org Consumer Project on Technology | mailto:love@cptech.org P.O. Box 19367 | voice: 1.202.387.8030 Washington, DC 20036 | fax: 1.202.234.5176 ======================================================= From owner-pharm-policy@venice.essential.org Mon Feb 7 11:25:34 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id BC4F821AFF for ; Mon, 7 Feb 2000 11:25:34 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id LAA24207 for ; Mon, 7 Feb 2000 11:25:34 -0500 Sender: jamie@genoa.essential.org Message-ID: <389EF253.51B5DC95@cptech.org> Date: Mon, 07 Feb 2000 11:26:59 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Note on d4T Subject: [Ip-health] correction on d4t Date: Mon, 07 Feb 2000 10:56:17 -0500 From: Thiru Balasubramaniam Stavudine (d4t) was originally synthesized by Dr. Jerome Horowitz of the Michigan Cancer Foundation in 1966 on a grant from the National Cancer Institute. Dr. William Prusoff of Yale University first discovered d4T's capability to treat HIV/AIDS. Yale University holds the key use patent. Yale licensed d4T to Bristol-Myers Squibb for marketing and distribution on January 12, 1988. Yale used significant government funding under Grant CA-28852 from the NIH. Thiru From owner-pharm-policy@venice.essential.org Mon Feb 7 12:09:05 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id DDFB421B6F for ; Mon, 7 Feb 2000 12:09:05 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id MAA25735 for ; Mon, 7 Feb 2000 12:09:05 -0500 Sender: jamie@genoa.essential.org Message-ID: <389EFC87.CDFAA67A@cptech.org> Date: Mon, 07 Feb 2000 12:10:31 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=iso-8859-1 Content-Transfer-Encoding: 8bit Subject: [Pharm-policy] fy 2001 NIH budget is $19 billion According to the White House, the new NIH budget for biomedical research is $19 billion, for fy 2001. http://www.whitehouse.gov/WH/New/00Budget/ "$1 billion Increase in Biomedical Research at the National Institutes of Health (NIH). The President's FY2001 budget includes almost $19 billion, an increase of $1 billion over last year's funding level, for biomedical research at NIH. In addition, the President will eliminate the delays in releasing $4 billion in research funds as required in last year's appropriations bill. This increase will support research in areas such as diabetes, brain disorders, cancer, genetic medicine, disease prevention strategies, and development of an AIDS vaccine. It will also help researchers complete in the near future a first draft of the entire human genome ­ the very blueprint of life. This and other wise investments in science are leading to a revolution in our ability to detect, treat, and prevent disease. If Congress passes the President's proposal, funding for NIH will increase by over 80 percent ­ nearly twice what the NIH budget was when President Clinton came into office. ======================================================= James Love, Director | http://www.cptech.org Consumer Project on Technology | mailto:love@cptech.org P.O. Box 19367 | voice: 1.202.387.8030 Washington, DC 20036 | fax: 1.202.234.5176 ======================================================= From owner-pharm-policy@venice.essential.org Mon Feb 7 18:39:11 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id CDA1621AFF for ; Mon, 7 Feb 2000 18:39:11 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id SAA02376 for ; Mon, 7 Feb 2000 18:39:11 -0500 Sender: jamie@genoa.essential.org Message-ID: <389F57F8.21BE582B@cptech.org> Date: Mon, 07 Feb 2000 18:40:40 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] 2 Articles from Science These were two influential articles in Science about patents. The first one, about the "anticommons," was an influential statement of the costs of patents on innovation, and a call for policies that limited the use of restrictive licensing of intellectual property. Jamie Jamie http://www.sciencemag.org/cgi/content/full/280/5364/698 Can Patents Deter Innovation? The Anticommons in Biomedical Research Michael A. Heller, Rebecca S. Eisenberg Volume 280, Number 5364 Issue of 1 May 1998, pp. 698 - 701 1998 by The American Association for the Advancement of Science. http://www.sciencemag.org/cgi/content/full/280/5364/689 BIOTECHNOLOGY: The Patenting of DNA Volume 280, Number 5364 Issue of 1 May 1998, pp. 689 - 690 1998 by The American Association for the Advancement of Science. ======================================================= James Love, Director | http://www.cptech.org Consumer Project on Technology | mailto:love@cptech.org P.O. Box 19367 | voice: 1.202.387.8030 Washington, DC 20036 | fax: 1.202.234.5176 ======================================================= From owner-pharm-policy@venice.essential.org Tue Feb 8 09:49:10 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id F33EB21B07 for ; Tue, 8 Feb 2000 09:49:09 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id JAA12677 for ; Tue, 8 Feb 2000 09:49:09 -0500 Sender: jamie@genoa.essential.org Message-ID: <38A02D45.85FEFEC9@cptech.org> Date: Tue, 08 Feb 2000 09:50:45 -0500 From: James Love Organization: http://www.cptech.org X-Mailer: Mozilla 4.61 [en] (X11; U; Linux 2.2.12-20 i686) X-Accept-Language: en MIME-Version: 1.0 To: pharm-policy Content-Type: text/plain; charset=us-ascii Content-Transfer-Encoding: 7bit Subject: [Pharm-policy] Development of Stavudine (d4T) Since there is a dispute in Thailand regarding Stavudine (d4T), I thought it would be useful to review some of the background in the drug. Thanks for Thiru for gathering this information. Discovery of d4T Stavudine (d4t) was originally synthesized by Dr. Jerome Horowitz of the Michigan Cancer Foundation in 1966 on a grant from the National Cancer Institute. (Incidentally, some researchers apparently use this date to estimate the length on time it takes a company to develop an HIV/AIDS drug, even though this research was publicly funded, and not done by a drug company). Discovery that d4T would treat HIV/AIDs Dr. William Prusoff of Yale University first discovered d4T's capability to treat HIV/AIDS. Yale University holds the key use patent. The patent number in the USA is 4,978,655, which lists the inventors as Tai-Shun Lin and William H. Prusoff. The patent is assigned to Yale University. On the patent, it isays: This invention was made with United States government support under Grant CA-28852 from the NIH. The United States Government has certain rights in this invention. Yale filed for patent rights in the USA, Australia, Canada, Denmark, Egypt, Ireland, Israel, Korea, Mexico, New Zealand, Philippines, Portugal, Singapore, South Africa, Taiwan, Romania, Austria, Belgium, France, Germany, Great Britain, Greece, Netherlands, Italy, Luxembourg, Spain, Sweden, and Switzerland. It is possible that other firms may be sought to obtain patents on d4T in other countries, particularly in countries that have a "first to file" system. Other persons may also hold other patents on d4T, such as formulation, dose or treatment regime patents. We have not looked at this yet. But the US "orange" book only lists the Yale patent. License to BMS The Yale patent was filed in the US on December 17, 1986, and approved on December 18, 1990. But Yale licensed its marketing and distribution rights to Bristol-Myers Squibb on January 12, 1988. NIAID and BMS Phase I/II trials On March 23, 1989, one year and two months after the Yale license to BMS, NIAID and BMS began a Phase I/II trial for d4T. The projected accrual was 40 patients, 5 per treatment arm (10 week induction up to 104 weeks maintenance). BMS trial used in NDA The trial used by BMS for Marketing approval was AI455-019, which looked at d4T in monotherapy. It was conducted between May 19, 1992 and August 12, 1994. This was a BMS sponsored Phase II/III trial with 822 patients. The median analysis time was 6 months. The trial began one year and five months after the Yale patent was approved. NDA approval The NDA was filed on December 28, 1993, and approved in less than six months, on June 24, 1994. This was 2 years, one month and five days after the beginning of the Ai455-019 trial. There was subsequent testing of d4T, and expanded marketing approvals for use in combination therapy. ======================================================= James Love, Director | http://www.cptech.org Consumer Project on Technology | mailto:love@cptech.org P.O. Box 19367 | voice: 1.202.387.8030 Washington, DC 20036 | fax: 1.202.234.5176 ======================================================= From owner-pharm-policy@venice.essential.org Tue Feb 8 10:10:54 2000 Return-Path: Delivered-To: pharm-policy@venice.essential.org Received: from genoa.essential.org (genoa.essential.org [216.0.124.11]) by venice.essential.org (Postfix) with ESMTP id 6610421AFF for ; Tue, 8 Feb 2000 10:10:54 -0500 (EST) Received: from cptech.org (jamie.essential.org [216.0.124.36]) by genoa.essential.org (8.9.3/8.9.3) with ESMTP id KAA13226 for