[Ip-health] Lilly sues Ausies under U.S.-Aust FTA
Flynn, Sean M.
sean.flynn@spiegelmcd.com
Tue May 16 10:41:17 2006
Drug Company Uses U.S. Trade Agreement to Challenge Australian Health Progr=
am
California Legislators Concerned State Drug Programs Are Next
Sacramento - Concerns expressed just over a year ago by State Senator Liz F=
igueroa (D-Fremont) are now ringing true as an international trade agreemen=
t is being used to undermine government efforts to keep prescription drugs =
affordable. The pharmaceutical company Eli Lilly is using the U.S. -- Aust=
ralia Free Trade Agreement to challenge an Australian drug purchasing decis=
ion.
"The challenge to Australia's health program is a clear sign of the legal m=
aneuvering by pharmaceutical companies to undercut government strategies th=
at provide affordable drugs for residents," said Figueroa. "We have no ass=
urances that California's affordable drug programs are immune to similar ba=
ck-door attacks."
The challenge comes after the Australian government refused to put an osteo=
porosis drug on their drug formulary under the Pharmaceutical Benefits Sche=
me (PBS), noting that the drug had "uncertain clinical benefit" and "uncert=
ain and unacceptable cost-effectiveness."
The Australian PBS weighs a variety of factors, including cost, to determin=
e whether new drugs will be covered by the government program. California =
and many other states use contract lists or preferred drug lists (PDL) as a=
way to promote efficacious, safe and cost-effective products and to discou=
rage the promotion of excessively expensive alternatives. The main differe=
nce between state PDL's and the Australian PBS is that Australia outright e=
liminates coverage for any drug not placed on the formulary, whereas states=
cover the drug but require prior authorization of any drug not placed on a=
preferred drug list. In both cases, the threat of not being placed on the=
preferred list encourages drug companies to lower their prices.
A little known provision in the Australia trade agreement reduces governmen=
t bargaining power by essentially making it a trade violation for governmen=
ts to consider cost in prescription drug programs. It further allows priva=
te companies to seek independent reviews of government drug coverage decisi=
ons, a provision that Eli Lilly is using to challenge the Australian decisi=
on.
Senator Figueroa and other legislators are seeking a legally binding commit=
ment from the U.S. government that the U.S. - Australia Free Trade Agreemen=
t can not be used to undermine state drug programs.
SJR 25, authored by Figueroa, calls on the federal government to issue an "=
Interpretive Note" with the government of Australia clarifying that state h=
ealth programs and other programs that receive federal funding are not cove=
red by the scope of the agreement. The resolution was approved by the Sena=
te earlier today and now heads to the Assembly for further review.
-----Original Message-----
From: ip-health-admin@lists.essential.org
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ip-health-request@lists.essential.org
Sent: Thursday, May 11, 2006 12:00 PM
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Subject: Ip-health digest, Vol 1 #2050 - 20 msgs
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When replying, please edit your Subject line so it is more specific
than "Re: Contents of Ip-health digest..."
Today's Topics:
1. Wary of Backlash, Cancer-Drug Makers Weigh Price Limits (Joana Ramos)
2. Barbour, Chinnock, Cohen and Yamey in the WHO Bulletin: The impact
of open access upon public health (Thiru Balasubramaniam)
3. Sisule Musungu (abstract) in the WHO Bulletin: Benchmarking progress
in tackling the challenges of intellectual property, and access to m=
edicines
in developing countries (Thiru Balasubramaniam)
4. Vasan et. al in the WHO Bulletin: The pricing and procurement of
antiretroviral drugs: an observational study of data from the Global=
Fund (Thiru Balasubramaniam)
5. James Love in the WHO Bulletin: Drug development to improve access
to essential medicines (Thiru Balasubramaniam)
6. Ellen 't Hoen in the WHO Bulletin: Report of the Commission on Intell=
ectual
Property Rights, Innovation and Public Health: a call to governments=
(Thiru Balasubramaniam)
7. Carlos Correa in the WHO Bulletin (abstract): Implications of bilate=
ral
free trade agreements on access to medicines (Thiru Balasubramaniam)
8. The Guardian: Drug firms seek to stop generic HIV treatment (Sheila.S=
HETTLE@geneva.msf.org)
9. IHT: AIDS drug provokes patent battle in India (Sheila.SHETTLE@geneva=
.msf.org)
10. Financial Times: Indian Aids victims in patents protest (Thiru Balasu=
bramaniam)
11. Tomris Turmen and Charles Clift in the WHO Bulletin: Public health,
innovation and intellectual property rights: unfinished business (Th=
iru Balasubramaniam)
12. Wall Street Journal: Generics Work Against Bird Flu (Thiru Balasubram=
aniam)
--__--__--
Message: 1
Date: Wed, 10 May 2006 10:04:25 -0700
From: Joana Ramos <joaninha@comcast.net>
To: IP-Health <" ip-health"@lists.essential.org>
Subject: [Ip-health] Wary of Backlash, Cancer-Drug Makers Weigh Price Limit=
s
[ Converted text/html to text/plain ]
Wary of Backlash, Cancer-Drug Makers Weigh Price Limits
By JOHN CARREYROU and GEETA ANAND
Wall Street Journal
May 10, 2006; Page B1
http://online.wsj.com/article/SB114723008884948630.html[1]
As high prices of cancer drugs spark the kind of patient outrage that high
AIDS-drug prices unleashed more than a decade ago, a few pharmaceutical and
biotech companies are weighing caps and other cost-containment measures,
before the outcry turns into a public-relations crisis for the industry.
ImClone Systems[2] Inc. and Bristol-Myers Squibb[3] Co., co-marketers of
Erbitux, one of the most expensive cancer drugs on the market, are "well do=
=3D
wn
the road" toward establishing an annual patient price cap for the drug if i=
=3D
ts
market expands, says Ronald Martell, senior vice president of commercial
operations at ImClone. Such a program would set an annual ceiling on
individual patients' drug-treatment costs, beyond which companies would
provide the drug free of charge or at a steep discount. Genentech[4] Corp.,=
=3D
of
South San Francisco, Calif., is considering cost-containing alternatives fo=
=3D
r
Avastin, which is currently approved for treatment of early-stage colorecta=
=3D
l
cancer.
While the backlash against cancer-drug prices is nowhere near as big as the
one against AIDS-drug prices, ImClone's Mr. Martell says the industry shoul=
=3D
d
make changes in its policies now. "Otherwise, at some point there will be a
confluence of events -- social pressure, volume of dollars -- and something
will have to give," he warns.
Erbitux, priced at $10,000 a month, is currently approved only for patients
with metastatic colorectal cancer who have failed a certain kind of
chemotherapy. Their average total cost of treatment is currently about
$40,000: In most of these patients, the illness has advanced to the point
where they are only a few months from death.
But later this year, ImClone and Bristol-Myers, both based in New York, hop=
=3D
e
to win Food and Drug Administration approval to market Erbitux for patients=
=3D
in
earlier stages of colorectal cancer, who have longer life expectancies.
Approval for these patients would result in a sharp rise in the average cos=
=3D
t
of treatment with Erbitux -- and a sharp rise in profits.
In the case of Genentech's Avastin, the current cost of treatment -- $4,400=
=3D
a
month, or $52,000 a year -- could rise sharply if the FDA approves the drug=
=3D
as
a treatment -- at double the dose -- to treat lung cancer and breast cancer=
=3D
.
Such approvals, expected over the next year, could result in thousands of n=
=3D
ew
patients paying, at current prices, more than $100,000 a year to take Avast=
=3D
in.
The Medicare Modernization Act of 2003, which extended prescription-drug
benefits to the elderly, has put financial pressure on elderly cancer
patients, the age group with the highest rates of the disease. Under the ol=
=3D
d
system, cancer patients receiving drugs intravenously at a hospital in
practice often weren't forced to make their 20% co-payment: The hospital wo=
=3D
uld
bill Medicare directly, and the Medicare reimbursement price -- as much as =
=3D
25%
above the drugs' market price -- provided a sufficient profit cushion so th=
=3D
at
hospitals often didn't collect co-payments.
But now, Medicare reimbursements are in line with drugs' actual selling
prices, and physicians and hospitals can no longer afford to forgive
co-payments. As a result, many elderly cancer patients without supplemental
prescription-drug insurance end up on the hook for thousands of dollars.
"There's a groundswell of patients who are outraged," says Jerry Flanagan,
health-care policy director for the Foundation for Taxpayer & Consumer Righ=
=3D
ts,
a Los Angeles watchdog group.
The Medicare overhaul has made a drug-price cap difficult to design. Medica=
=3D
re
drug reimbursement rates are now set at a drug's average wholesale price pl=
=3D
us
6%. Every time ImClone gives Erbitux free to patients, the government formu=
=3D
la
would count a sale at a price of zero dollars -- driving down the drug's
average price. "It would send the drug into a downward spiral," ImClone's M=
=3D
r.
Martell says. The more free Erbitux dispensed, the lower the price would go=
=3D
.
As a result, ImClone instead is considering directing patients who exceed t=
=3D
he
cap and meet income guidelines to an independent charitable program that wo=
=3D
uld
provide the drug free or at a fraction of the price. Mr. Martell says ImClo=
=3D
ne
and Bristol-Myers haven't agreed on the dollar value of the cap yet, and
pricing decisions ultimately rest with Bristol-Myers. Bristol-Myers decline=
=3D
d
to comment for this story.
"If we do a program like a cap," ImClone's Mr. Martell says, "it would not
only help patients but it would help the system as a whole" by limiting the
burden on government and private insurers.
Because most cancer drugs don't have competition, an increase in demand
usually drives prices up. A surge in patients taking a drug at higher doses
would substantially raise costs for private insurers and government.
Genentech says it is also weighing the use of an independent charity, among
other options, for giving away Avastin to patients who exceed a certain ann=
=3D
ual
spending limit. "We're trying to balance the interests of patients, the
interests of society and the company's interest -- and our desire to innova=
=3D
te
for the best drugs," says David Ebersman, Genentech's chief financial offic=
=3D
er.
A spokeswoman for the Centers for Medicare and Medicaid Services says
companies can provide free drugs to charities without affecting the average
sales price. But Walter Moore, vice president of government affairs at
Genentech, says hurdles remain, including Medicare reimbursement, which pay=
=3D
s
oncologists for infusing a drug only in conjunction with paying for the dru=
=3D
g.
Cancer drug prices, always considered high, have skyrocketed in recent year=
=3D
s.
Patient outcry was muted when few patients shouldered the cost of drugs
directly. But now, some private insurers and employers are requiring patien=
=3D
ts
to pay 10% to 50% of the cost of expensive pills and infused drugs, such as
Erbitux, adding up to annual drug bills in the tens of thousands of dollars=
=3D
.
Fears about the price of the cancer drug Revlimid prompted the Internationa=
=3D
l
Myeloma Foundation, an advocacy group, earlier this year to seek a meeting
with the manufacturer, Celgene[5] Corp., of Summit, N.J. Celgene had priced
the drug at around $4,600 a month, or $55,000 a year, after the FDA approve=
=3D
d
it in December for a rare blood disorder called myelodysplastic syndrome.
Early this year, patients with a different disorder, multiple myeloma, bega=
=3D
n
to worry they wouldn't be able to afford the drug if it were approved for
their disease, which investors expect in June. The dose for treating multip=
=3D
le
myeloma is 2=3DBD times the dose required for treating the approved disorde=
r.
Patients did the math and envisioned drug costs of $135,000 a year.
Susie Novis, the myeloma foundation's president, says Celgene executives in
February assured her the price increase would be limited but declined to be
specific. A spokesman for Celgene says the company will price the higher do=
=3D
se
at less than 2=3DBD times the price of the lower dose.
Protests over AIDS-drug prices peaked in the U.S. in the late 1980s. Activi=
=3D
sts
in 1989 staged demonstrations against Wellcome PLC, now part of
GlaxoSmithKline[6] PLC, which makes the AIDS drug AZT. In one protest, five
activists chained themselves to a balcony inside the New York Stock Exchang=
=3D
e
holding a banner that read, "Sell Wellcome." Wellcome lowered the price of =
=3D
AZT
several times from $10,000 a year in 1987 to $4,000 by 1998.
Today, AIDS drugs remain much cheaper on average than cancer drugs. To avoi=
=3D
d
antagonizing AIDS activists, Celgene priced the drug thalidomide at $6 a
50-milligram pill in 1998. But when doctors stopped prescribing the drug as=
=3D
an
AIDS-wasting treatment and started prescribing it primarily for cancer,
Celgene gradually raised its price to $63.50 a pill. Celgene says it raised
prices because the value of the drug increased.
Cancer-drug prices raise eyebrows even on Wall Street. Steven Harr, a Morga=
=3D
n
Stanley biotech analyst, estimates oncology drugs will make up 22% of U.S.
drug spending in 2007, compared with 16% in 2004. He expects government and
private health insurers to push back.
Fred Hassan, chief executive of Schering-Plough[7] Corp., maker of Temodar,=
=3D
a
drug for brain tumors, says the controversy over escalating cancer-drug pri=
=3D
ces
is creating "a healthy debate." "These prices are high, $100,000 a year is
high," he says. Still, he adds, high prices are partly justified by the hig=
=3D
h
cost of cancer research and the high rate of product failure.
Write to John Carreyrou at john.carreyrou@wsj.com[8] and Geeta Anand at
geeta.anand@wsj.com[9]
--
Joana Ramos, MSW
Cancer Resources & Advocacy
7303 23rd Ave. NE
Seattle, WA 98115
206-229-2420
http://ramoslink.info/[10]
=3D3D=3D3D=3D3DReferences:=3D3D=3D3D=3D3D
1. http://online.wsj.com/article/SB114723008884948630.html
2. http://online.wsj.com/quotes/main.html?type=3D3Ddjn&symbol=3D3Dimc=
l
3. http://online.wsj.com/quotes/main.html?type=3D3Ddjn&symbol=3D3Dbmy
4. http://online.wsj.com/quotes/main.html?type=3D3Ddjn&symbol=3D3Ddna
5. http://online.wsj.com/quotes/main.html?type=3D3Ddjn&symbol=3D3DCEL=
G
6. http://online.wsj.com/quotes/main.html?type=3D3Ddjn&symbol=3D3Dgsk
7. http://online.wsj.com/quotes/main.html?type=3D3Ddjn&symbol=3D3Dsgp
8. mailto:john.carreyrou@wsj.com
9. mailto:geeta.anand@wsj.com
10. http://ramoslink.info/
--__--__--
Message: 2
Date: Thu, 11 May 2006 12:14:28 +0200
From: Thiru Balasubramaniam <thiru@cptech.org>
To: ip-health@lists.essential.org
Subject: [Ip-health] Barbour, Chinnock, Cohen and Yamey in the WHO Bulletin=
: The impact
of open access upon public health
http://www.who.int/bulletin/volumes/84/5/editorial20506html/en/index.html
The impact of open access upon public health
Virginia Barbour (a), Paul Chinnock (a), Barbara Cohen (a) & Gavin Yamey (a=
=3D
)
Arthur Amman, President of Global Strategies for HIV Prevention
(www.globalstrategies.org), tells the following story:
=3D93I recently met a physician from southern Africa, engaged in perinatal
HIV prevention, whose primary access to information was abstracts posted
on the Internet. Based on a single abstract, they had altered their
perinatal HIV prevention program from an effective therapy to one with
lesser efficacy. Had they read the full text article they would have
undoubtedly realized that the study results were based on short-term
follow-up, a small pivotal group, incomplete data, and were unlikely to
be applicable to their country situation. Their decision to alter
treatment based solely on the abstract=3D92s conclusions may have resulted
in increased perinatal HIV transmission.=3D94
Amman=3D92s story shows the potentially deadly gap between the
information-rich and the information-poor. This gap is not the result of
lack of technology or of money, but of a failure of imagination. We live
in the most information-rich era of history, when the Internet allows
immediate global dissemination of crucial health information, and the
inter-linking of online information creates an integrated, living body
of information =3D97 the ultimate vision of which is the semantic web.(1)
What is preventing such a living web? For scientific and medical
information, two obstacles are vested interests and traditions. Central
to these traditions is the role of copyright, which was developed when
the dissemination of work was on paper. Initially, applying copyright to
medical articles protected both the intellectual investment of authors
and the commercial investment of publishers. Authors of scientific
articles handed over their copyright to the publishers to prevent
unauthorized print copying. Thus, the prevention of unauthorized copying
helped to disseminate information, by providing a valid business model
for publishers. But the proliferation of subscription-based medical and
scientific journals led to readers having to pay more and more to
publishers in order to keep up with current knowledge, and an increasing
fragmentation of knowledge between different publishers.
Print is no longer the most efficient way to disseminate information.
The Internet provides the means to revolutionize publishing in two
crucial ways. First, it makes it possible to disseminate health
information at no charge to anyone in the world with online access.
Although it costs money to peer review, edit, produce, and host an
online article, this is a one-time, fixed cost. If research funders are
willing to pay this cost, then the published work can be made freely
available to all readers worldwide, and there would be no need for
journal subscriptions. This is one way of financing an open-access model
of publishing. (2)
Second, because the Internet allows not just ease of access but ease of
reuse, an article=3D92s usefulness is limited only by a user=3D92s imaginat=
ion.
To allow this, the traditional role of copyright has to change. Instead
of publishers using copyright to restrict use, authors can retain
copyright and grant the public the right to creatively reuse their work.
Licences such as those developed by the Creative Commons, (3) which
facilitate rather than prohibit reuse, are used by the open-access
publishers Public Library of Science (PLoS) (4) and BioMed Central
(BMC). The result is that: =3D93=3D85 copyright can be used for what it is =
mean=3D
t
to in science, not to make the articles artificially scarce and in the
process restrict their distribution, but instead, to ensure that their
potential for maximum possible dissemination can be realised.=3D94 (5)
The potential benefits of such a change are vast. No longer will
physicians have to base their practice on half truths. Instead, everyone
from patients to policy-makers can read for themselves the evidence on
which crucial science and health policy decisions are made. One example
of a paper with potentially profound public health implications is the
first randomized trial of male circumcision to prevent HIV infection;
(6) having this paper and all related discussions freely available has
allowed a lively, informed debate to flourish.
Will poorly funded researchers be excluded from publishing in
open-access journals? This concern is addressed head on by publishers
such as PLoS and BMC who waive fees for authors who cannot pay and who
strictly separate decisions on publication from ability to pay. This is
not a radical departure into subsidies, but an accepted part of
distributing publishing costs across the scientific community.
Increasingly, funders of research also realize the benefit of an
open-access model of publishing. The UK=3D92s Wellcome Trust (7) mandates
its funded authors to make their work publicly available; the United
States National Institutes of Health are encouraging it, (8) and
increasing numbers of governments and funding bodies are signing up to
declarations on open access. (9)
It may be uncomfortable for those with interest in the status quo, but
by regaining control of copyright the medical and scientific communities
could ensure that publishing is no longer driven by the interests of
publishers, but rather by the needs of society.
Competing interests: The authors are employed by the Public Library of
Science, an open-access publisher. This editorial is being co-published
in PLoS Medicine (www.plosmedicine.org <http://www.plosmedicine.org>).
REFERENCES:
* W3C The World Wide Web Consortium Available from: http://www.w3.org/
* Suber P. Open Access Overview. Available from:
http://www.earlham.edu/~peters/fos/overview.htm
* Creative Commons. Available from: http://creativecommons.org/
* Gass A, Doyle H, Kennison R. Whose Copy? Whose Rights? PLoS Biol
2004;2:e228
* Velterop J. Guide to Open Access Publishing and Scholarly
Societies, Open Society Institute, July 2005. Available from:
http://www.soros.org/openaccess/scholarly_guide.shtml
* Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta R,
Puren A. Randomized, Controlled Intervention Trial of Male
Circumcision for Reduction of HIV Infection Risk: The ANRS 1265
Trial. PLoS Med 2005;2:e298.
* Wellcome Trust position statement in support of open and
unrestricted access to published research. February 2006.
Available from: http://www.wellcome.ac.uk/doc_WTD002766.html
* Policy on Enhancing Public Access to Archived Publications
Resulting from NIH-Funded Research. Available from:
http://publicaccess.nih.gov/
* Berlin declaration on Open Access. Available from:
http://www.zim.mpg.de/openaccessberlin/berlindeclaration.html
(a) PLoS Medicine, Public Library of Science, 185 Berry Street, Suite
3100, San Francisco, CA 94107, USA. Correspondence to Virginia Barbour
--__--__--
Message: 3
Date: Thu, 11 May 2006 12:25:28 +0200
From: Thiru Balasubramaniam <thiru@cptech.org>
To: ip-health@lists.essential.org
Subject: [Ip-health] Sisule Musungu (abstract) in the WHO Bulletin: Benchma=
rking progress
in tackling the challenges of intellectual property, and access to medicin=
es
in developing countries
The whole text of this article may be downloaded from this url:
http://www.who.int/entity/bulletin/volumes/84/5/366.pdf
------------
http://www.who.int/bulletin/volumes/84/5/musungu0506abstract/en/index.html
Benchmarking progress in tackling the challenges of intellectual
property, and access to medicines in developing countries
Sisule F Musungu
ABSTRACT
The impact of intellectual property protection in the pharmaceutical
sector on developing countries has been a central issue in the fierce
debate during the past 10 years in a number of international fora,
particularly the World Trade Organization (WTO) and WHO. The debate
centres on whether the intellectual property system is: (1) providing
sufficient incentives for research and development into medicines for
diseases that disproportionately affect developing countries; and (2)
restricting access to existing medicines for these countries. The Doha
Declaration was adopted at WTO in 2001 and the Commission on
Intellectual Property, Innovation and Public Health was established at
WHO in 2004, but their respective contributions to tackling intellectual
property-related challenges are disputed. Objective parameters are
needed to measure whether a particular series of actions, events,
decisions or processes contribute to progress in this area. This article
proposes six possible benchmarks for intellectual property-related
challenges with regard to the development of medicines and ensuring
access to medicines in developing countries.
--__--__--
Message: 4
Date: Thu, 11 May 2006 12:31:28 +0200
From: Thiru Balasubramaniam <thiru@cptech.org>
To: ip-health@lists.essential.org
Subject: [Ip-health] Vasan et. al in the WHO Bulletin: The pricing and proc=
urement of
antiretroviral drugs: an observational study of data from the Global Fund
The full text of this article may be read at the following link:
http://www.who.int/entity/bulletin/volumes/84/5/393.pdf
--------------------
http://www.who.int/bulletin/volumes/84/5/vasan0506abstract/en/index.html
The pricing and procurement of antiretroviral drugs: an observational
study of data from the Global Fund
Ashwin Vasan, David Hoos, Joia S Mukherjee, Paul E Farmer, Allan G
Rosenfield, & Joseph H Perri=3DEBns
ABSTRACT
The Purchase price report released in August 2004 by the Global Fund to
Fight AIDS, Tuberculosis, and Malaria (Global Fund) was the first
publication of a significant amount of real transaction purchase data
for antiretrovirals (ARVs). We did an observational study of the ARV
transaction data in the Purchase price report to examine the procurement
behaviour of principal recipients of Global Fund grants in developing
countries. We found that, with a few exceptions for specific products
(e.g. lamivudine) and regions (e.g. eastern Europe), prices in
low-income countries were broadly consistent or lower than the lowest
differential prices quoted by the research and development sector of the
pharmaceutical industry. In lower middle-income countries, prices were
more varied and in several instances (lopinavir/ritonavir, didanosine,
and zidovudine/lamivudine) were very high compared with the per capita
income of the country. In all low- and lower middle-income countries,
ARV prices were still significantly high given limited local purchasing
power and economic strength, thus reaffirming the need for donor support
to achieve rapid scale-up of antiretroviral therapy. However, the price
of ARVs will have to decrease to render scale-up financially sustainable
for donors and eventually for governments themselves. An important first
step in reducing prices will be to make available in the public domain
as much ARV transaction data as possible to provide a factual basis for
discussions on pricing. The price of ARVs has considerable implications
for the sustainability of human immunodeficiency virus/acquired
immunodeficiency syndrome (HIV/AIDS) treatment in the developing world.
--__--__--
Message: 5
Date: Thu, 11 May 2006 12:44:10 +0200
From: Thiru Balasubramaniam <thiru@cptech.org>
To: ip-health@lists.essential.org
Subject: [Ip-health] James Love in the WHO Bulletin: Drug development to im=
prove access
to essential medicines
James Love's piece, "Drug development to improve access to essential
medicines" can be found on page 408 in the following link.
http://www.who.int/entity/bulletin/volumes/84/5/405.pdf
--__--__--
Message: 6
Date: Thu, 11 May 2006 12:48:59 +0200
From: Thiru Balasubramaniam <thiru@cptech.org>
To: ip-health@lists.essential.org
Subject: [Ip-health] Ellen 't Hoen in the WHO Bulletin: Report of the Commi=
ssion on Intellectual
Property Rights, Innovation and Public Health: a call to governments
The full text of Ellen 't Hoen's piece, " Report of the Commission on
Intellectual Property Rights, Innovation and Public Health: a call to
governments" can be found here:
http://www.who.int/entity/bulletin/volumes/84/5/421.pdf
--__--__--
Message: 7
Date: Thu, 11 May 2006 12:58:47 +0200
From: Thiru Balasubramaniam <thiru@cptech.org>
To: ip-health@lists.essential.org
Subject: [Ip-health] Carlos Correa in the WHO Bulletin (abstract): Implica=
tions of bilateral
free trade agreements on access to medicines
The full text of Carlos Correa's article can be found here:
http://www.who.int/entity/bulletin/volumes/84/5/399.pdf
---------------
http://www.who.int/bulletin/volumes/84/5/correa0506abstract/en/index.html
Implications of bilateral free trade agreements on access to medicines
Carlos Mar=3DEDa Correa
ABSTRACT
The TRIPS Agreement of the World Trade Organization (WTO) mandated the
introduction of protection of intellectual property rights, notably
patents, for pharmaceutical products. While the implications for the
access to medicines contained in the terms of this Agreement raised
significant concerns, a recent new wave of free trade agreements,
negotiated outside the WTO, requires even higher levels of intellectual
property protection for medicines than those mandated by that Agreement.
The measures involved include the extension of the patent term beyond 20
years; prohibition of use of test data on drug efficacy and safety for
certain periods for the approval of generic products; the linkage
between drug registration and patent protection; in some cases,
limitations to the grounds for granting compulsory licences. This
article reviews some of these measures that further limit the
competition of generic products and discusses their possible implication
for access to medicines.
--__--__--
Message: 8
To: ip-health@lists.essential.org
From: Sheila.SHETTLE@geneva.msf.org
Date: Thu, 11 May 2006 13:44:13 +0200
Subject: [Ip-health] The Guardian: Drug firms seek to stop generic HIV trea=
tment
Drug firms seek to stop generic HIV treatment
Randeep Ramesh in New Delhi
Thursday May 11, 2006
The Guardian
Multinational drug firms have begun to seek patents for Aids drugs in
India, a main source of cheap treatments, provoking protests from
campaigners and patients who say this will stifle supplies of affordable
therapies.
Until last year India permitted the copying of patented drugs, which
allowed the country's pharmaceutical industry to sell cheap versions of
Aids drug cocktails, known as antiretrovirals. Legislation enacted in March
2005 curtails the ability of firms to make copycat treatments and allows
foreign pharmaceutical companies to claim ownership of drugs.
The California-based Gilead and Britain's GlaxoSmithKline, have now applied
for patents on two HIV treatments. Campaigners, lawyers and Indian drug
makers have opposed the applications, and more than 100 people were
arrested in protests yesterday in Delhi.
Activists say patents would drive up prices as Indian manufacturers would
have to pay royalties and rival generic versions would be blocked for 20
years.
Gilead has sought a patent on a key Aids treatment called tenofovir
(Viread), while Glaxo has sought one for a widely used drug called
Combivir. Lawyers say 8,000 patent applications are in the pipeline.
Exports by Indian companies helped to cut the price of antiretroviral
treatment from $15,000 (=3DA38,000) per patient per year a decade ago to $2=
00=3D
.
Indian companies now provide two-thirds of the world's cheap Aids
therapies.
Campaigners say that as Aids patients develop a resistance to "first-line"
drugs, there will be no scope for a reduction in prices of
second-generation medicines without the Indian generic drugs. The
second-generation drugs are already 10 times more expensive than older
treatments.
"Granting [these patents] would set a dangerous precedent," said Ellen 't
Hoen, director of policy at Medecins sans Frontieres. "We will be back to
the days when multinationals controlled the price."
Drug companies say they sell to poor countries at cheap rates and that
problems with public health systems, rather than patents, curtails
accessibility.
+++++++++++++++++++++
Sheila Shettle
Communications Officer
M=3DE9decins Sans Fronti=3DE8res
Campaign for Access to Essential Medicines
Rue de Lausanne 78
1211 Geneva
Switzerland
+ 41.22.849.8403
sheila.shettle@geneva.msf.org
www.accessmed-msf.org
--__--__--
Message: 9
To: Ip-health@lists.essential.org
From: Sheila.SHETTLE@geneva.msf.org
Date: Thu, 11 May 2006 13:37:10 +0200
Subject: [Ip-health] IHT: AIDS drug provokes patent battle in India
AIDS drug provokes patent battle in India
By Amelia Gentleman and Hari Kumar International Herald Tribune
THURSDAY, MAY 11, 2006
NEW DELHI A legal challenge to a patent application in India on a crucial
AIDS drug was filed this week in Delhi by two patients' rights groups, who
claim that thousands of lives could be put at risk if the patent is
approved.
If the drug, tenofovir, is granted a patent, the manufacture of cheaper
versions in India will become illegal, making the drug too expensive for
patients in developing countries.
The suit is one of the first major challenges to an Indian patent
legislation introduced last year that was designed to control the country's
large pharmaceutical industry, which for decades has specialized in making
cheaper copies of Western manufactured medicines.
The Indian patent office is processing about 9,000 patent applications,
most of them filed by international pharmaceutical companies. Patient
advocates warn that the supply of a wide range of vital drugs to people in
the developing world may be jeopardized. Hundreds of thousands of AIDS
patients in developing countries are treated with generic Indian drugs.
Those backing the legal challenge are hopeful that this case, if
successful, could help set a legal precedent, thereby making it easier to
block other pending patent applications. They say the recent rejection of a
patent application by Novartis for a cancer drug, on the grounds of similar
legal arguments, gives some cause for optimism.
The Delhi Network of Positive People and the Indian Network for People
Living with HIV/AIDS registered a formal opposition Tuesday to a patent
application by the U.S.-based Gilead Sciences for the drug tenofovir
disoproxil fumarate, commonly known just as tenofovir.
Their lawyers make the case on a scientific technicality, arguing that
tenofovir is not a new drug, but just a modified version of an earlier
drug, and therefore not eligible for a new patent under India's act.
The successful challenge to a patent for the cancer drug, Gleevac, was also
made on this basis - that the application claims "a new form of a known
substance."
The World Health Organization recently recommended the drug for patients
who are just starting treatment for AIDS and for those who have been
receiving anti-retroviral treatment therapy for some time, but who have
become resistant to other treatments. The drug has relatively few known
side effects and is in wide use in the United States and Europe, although
less so in the rest of the world.
"These generic drugs are not only consumed in India," said Leena Menghaney
of M=3DE9decins Sans Fronti=3DE8res, or Doctors Without Borders, in Delhi, =
whic=3D
h is
working with the Indian groups on the issue. "People in Africa and the
Caribbean are relying on India to produce these drugs.
"The quality matches that of U.S.- manufactured drugs, but the prices are
affordable. These drugs are very important, which is why we are opposing
this patent application.
"People who suffer extreme side effects from other drugs, and people who
have developed resistance to other drugs, have been waiting for an
effective substitute such as tenofovir. If they don't get it, then probably
their lives will be at risk, and certainly their quality of life will be
worse."
Eric Goermaere, of M=3DE9decins Sans Fronti=3DE8res in South Africa, said i=
n a
written statement: "We have all been waiting impatiently to get tenofovir
as a generic from India. It's clear that the world desperately needs more
sources of tenofovir. If Gilead is granted the patent, our patients will
face a potentially deadly delay."
In developed countries, Gilead's tenofovir costs $5,718 per patient per
year. According to company's Web site, it has been offering the drug at
cost to treatment programs in eligible developing countries. But officials
with M=3DE9decins Sans Fronti=3DE8res said the company has not yet made the=
dru=3D
g
available in many low-income regions. A spokeswoman for Gilead, Erin
Edgley, said in an e-mail message that the company declined to comment.
Cipla, one of the largest generics companies in India, is already marketing
a generic version of tenofovir, called tenvir, at a cost of $700 per person
per year in India.
Yusuf Hamied, chairman of Cipla, said the drug would in time be made
available in Africa for about half the price in India. Tenvir will have to
be withdrawn if the Gilead patent, which would last for 12 years, were
granted.
About 150 protesters, many of them HIV-positive, demonstrated outside the
Indian Parliament on Wednesday in support of the legal action, carrying
banners declaring "Patients before patents" and "Lives before profit." A
number of campaigners were detained when they crossed the police barriers.
Among the protesters was Loon Gangte, president of the Delhi Network of
Positive People, who like more than 5.1 million people in India is
HIV-positive.
"If this patent is granted, it will chop off a lifeline for me," he said,
adding that he has been taking anti-retroviral treatment for the past 3=3DB=
D
years. "Any time now I am going to become resistant to the first line
treatment and I will need new drugs. For many of us living with HIV/AIDS,
newer drugs like tenofovir offer new hope of continuing treatment.
"If the government grants the patent the price of these drugs will go up,
and I won't be able to afford them. It is a life- and-death issue for me
and many more people like me around the world. We do not want to die when
our lives can be easily saved."
The Indian patent law, introduced last March, was designed to regulate the
copying of Western medicines by the Indian pharmaceutical industry and to
bring the country into line with World Trade Organization rules.
International aid organizations warned that the legislation could mark the
beginning of the end of affordable generic drugs.
Supporters of the legislation counter that patents ensures that
pharmaceutical companies have the security to invest in further research
allowing them to develop vital drugs. They argue the patent law also
creates benefits for the Indian pharmaceutical industry as it begins to
develop world-class drugs. Those innovators will want protection from
generic copies.
The AIDS patients rights' groups issued the formal opposition to the patent
on a scientific technicality, arguing that tenofovir is not a new drug, but
just a modified version of an earlier drug.
Cipla plans to start a parallel legal opposition to the patent application.
"We have never been against intellectual property and patents," Hamied said
by telephone from Mumbai. "We are against monopoly. I believe that life-
saving, essential drugs should be freely available and the innovator should
be paid a suitable royalty payment for his invention."
He said he believed that a large number of the 9,000 patents currently
pending will ultimately prove to have no basis in law and will be rejected.
Most of them were filed speculatively before the Indian legislation was
passed in 2005 and before the precise details of the new legislation were
announced.
Hamied called on those multinational corporations with patents are pending
which do not comply with the current Indian law, "to withdraw them
voluntarily, instead of entering into litigation after litigation after
litigation."
+++++++++++++++++++++
Sheila Shettle
Communications Officer
M=3DE9decins Sans Fronti=3DE8res
Campaign for Access to Essential Medicines
Rue de Lausanne 78
1211 Geneva
Switzerland
+ 41.22.849.8403
sheila.shettle@geneva.msf.org
www.accessmed-msf.org
--__--__--
Message: 10
Date: Thu, 11 May 2006 15:46:19 +0200
From: Thiru Balasubramaniam <thiru@cptech.org>
To: ip-health@lists.essential.org
Subject: [Ip-health] Financial Times: Indian Aids victims in patents protes=
t
Indian Aids victims in patents protest
By Andrew Jack and Jo Johnson in New Delhi
Published: May 11 2006 03:00 | Last updated: May 11 2006 03:00
Hundreds of people affected by HIV/Aids yesterday marched on the Indian
parliament to support a legal challenge to a patentapplication on an
anti-retroviral drug, tenofovir, made by US pharmaceutical group Gilead
Sciences. The challenge will test the Indian patent regime put in place
last year. India's importance goes far beyond drug access for its own
population since it is a high-volume, low-cost centre for the production
and export of drugs for much of the developing world, undercutting
western branded medicinesIndia, dealing with a backlog of 7,000-9,000
applications in the patent "mailbox", faces the prospect of years of
intellectual property litigationpitting multinational drugs groups
against Indian generic manufacturers and NGOs.
Protesters chanted "We want tenofovir" and woreT-shirts blazoned with
the words "HIV positive". NGOs say India is largely in denial about an
epidemic affecting more than 5m people.
Lawyers advising the NGOs say the patent office should reject Gilead's
application on the grounds that the Californian group is trying to
patent a new form of a pre-existing drug without evidence of enhanced
therapeutic efficacy.
Indian drug companies, such as Cipla, have developed a low-cost generic
version of tenofovir, priced in India at a seventh of international
levels and would be likely to have to cease production or pay steep
royalties if a patent was granted.
--__--__--
Message: 11
Date: Thu, 11 May 2006 15:50:38 +0200
From: Thiru Balasubramaniam <thiru@cptech.org>
To: ip-health@lists.essential.org
Subject: [Ip-health] Tomris Turmen and Charles Clift in the WHO Bulletin: P=
ublic health,
innovation and intellectual property rights: unfinished business
http://www.who.int/bulletin/volumes/84/5/editorial10506html/en/index.html
Public health, innovation and intellectual property rights: unfinished
business
Tomris Turmen (a) & Charles Clift (b)
The context for this theme collection is the publication of the report
of the Commission on Intellectual Property Rights, Innovation and Public
Health. (1)
The report of the Commission =3D97 instigated by WHO=3D92s World Health Ass=
embl=3D
y
in 2003 =3D97 was an attempt to gather all the stakeholders involved to
analyse the relationship between intellectual property rights,
innovation and public health, with a particular focus on the question of
funding and incentive mechanisms for the creation of new medicines,
vaccines and diagnostic tests, to tackle diseases disproportionately
affecting developing countries.
In reality, generating a common analysis in the face of the divergent
perspectives of stakeholders, and indeed of the Commission, presented a
challenge. As in many fields =3D97 not least in public health =3D97 the evi=
denc=3D
e
base is insufficient and contested. Even when the evidence is reasonably
clear, its significance, or the appropriate conclusions to be drawn from
it, may be interpreted very differently according to the viewpoint of
the observer. As a result the outcome was inevitably a compromise, a
compromise which some of the Commissioners felt obliged to supplement by
providing their own perspective in commentaries on the report.
Now the report is finally published, what will be the outcome? Will the
carefully worded text and recommendations, the product of tortuous
negotiation, be plucked out of context and caricatured in the hands of
one set of stakeholders or another? Will straw men be erected, and
knocked down effortlessly, to demonstrate the absurd and extreme
positions in the report? Will debate still rage as to how important, or
how unimportant, intellectual property rights are to the promotion of
innovation and access? Will evidence still be used to promote one set of
preconceived opinions or another?
The report will succeed to the extent it makes a difference where it
really matters =3D97 to the lives of poor and sick people in developing
countries. The test will not be the initial flurry of stereotypical
instant reaction. Rather the report, which is strong on detail and
analysis, should repay careful study and mature reflection. If it makes
a contribution it will be through incrementally changing the terms of
the debate, and by legitimizing and making explicit certain lines of
thought or policy which had been previously poorly articulated, or
dismissed as beyond the bounds of political possibility.
The report provides a resource for the public health community by
clarifying the impact of institutions, systems and policies outside the
health sector on intellectual property rights and innovation policies.
A key message of the report is that because the market demand for
diagnostics, vaccines and medicines needed to address health problems
mainly affecting developing countries is small and uncertain, the
incentive effect of intellectual property rights may be limited or
non-existent. Because intellectual property rights may not be an
effective incentive in this area, there is a need for other incentives
and financial mechanisms to be put in place and for collaborative
efforts between different stakeholders.
Without access to the products of innovation, there can be no public
health benefits. Defining the conditions by which products can be
accessed is therefore an important aspect of the report. There has been
significant progress in recent years, such as the launch of new
public=3D96private partnerships for product development, increased funding
by foundations and new institutions to promote access such as the Global
Fund to Fight AIDS, Malaria and TB.
This momentum for change is welcome but is insufficient. Much more needs
to be done. There remain unsettled and debated issues in intellectual
property e.g. the effectiveness of the recent amendment to TRIPS in
increasing access to medicines in countries without manufacturing
capacity, the impact of data exclusivity laws and the impact of
intellectual property provisions in bilateral trade agreements.
There is a need to ensure enhanced financing on a sustainable basis of
innovation and access and promote synergy between the different
partners. Ultimately it is a responsibility that governments must accept
if these objectives are to be achieved.
It is appropriate that WHO should now take the lead in promoting a more
sustainable and better-funded effort and addressing unresolved issues.
WHO should accordingly develop a global plan of action to secure
enhanced and sustainable funding for developing and making accessible
products to address diseases that disproportionately affect developing
countries.
As the former Secretariat of the Commission it is our hope that the
report will stimulate governments, and other stakeholders, to promote
innovation relevant to the health of poor people in developing
countries, and their access to diagnostics, vaccines and treatments.
It is now up to WHO and its Member States to take up the task of
transforming the report into a workable set of policies and actions that
will really make a difference.
REFERENCES:
* Public health, innovation and intellectual property rights.
Geneva: Commission on Intellectual Property Rights, Innovation and
Public Health; 2006.
(a) World Health Organization, 1211 Geneva 27, Switzerland.
Correspondence to this author (email: turment@who.int)
(b) Commission on Intellectual Property Rights, Innovation and Public
Health, World Health Organization, Geneva, Switzerland.
--__--__--
Message: 12
Date: Thu, 11 May 2006 17:47:02 +0200
From: Thiru Balasubramaniam <thiru@cptech.org>
To: ip-health@lists.essential.org
Subject: [Ip-health] Wall Street Journal: Generics Work Against Bird Flu
http://online.wsj.com/article/SB114728376035549154.html
Generics Work Against Bird Flu
By *NICHOLAS ZAMISKA*
May 11, 2006; Page D3
A pair of generic drugs that are plentiful and cheaper than Tamiflu
could gain further credibility as a bird-flu treatment because of a
study in a prominent U.S. scientific journal.
The study, which will appear in a coming issue of the Journal of
Infectious Diseases, reports that the vast majority of strains of the
deadly avian-influenza virus, H5N1, found in China and Indonesia would
respond to the drugs, known as amantadine and rimantadine.
The research further erodes the conventional wisdom that these older
drugs are useless against bird flu in humans. It raises the possibility
that they may be employed selectively alongside Tamiflu, made by the
Swiss drug company *Roche Holding *AG, to treat victims of the virus and
to bolster government stockpiles of antiviral drugs.
"Amantadine appears to retain the potential to be useful in an H5N1
pandemic in the absence of a vaccine, as a prophylactic agent and as a
component of combination antiviral therapy," the study says.
In March, an official of the World Health Organization said that of the
approximately 130 strains of the H5N1 form of the virus whose sequences
the WHO had analyzed, about a quarter were sensitive to the older drugs.
Roche has said that all the strains of H5N1 that have been examined so
far would be susceptible to Tamiflu.
Early human cases of bird flu in Southeast Asia "gave people a
conception that H5N1 is probably resistant to amantadine," Honglin Chen,
a virologist at the University of Hong Kong and an author of the study,
said in an interview. "But if you analyze the viruses from China,
Indonesia and even the virus circulating in Europe and Africa, the
viruses are sensitive."
The study analyzed 638 H5N1 viruses from a handful of countries in Asia
-- 39 viruses from humans and 599 from birds. While more than 95% of
virus isolates from Vietnam and Thailand had mutations that would make
them resistant to the older drugs, the authors found, only 6.3% of those
from Indonesia and 8.9% from China did. Those results dovetail with
recent findings that the virus has evolved into distinct subgroups.
"Although amantadine-resistant H5N1 viruses are present in Asia, their
distribution appears to be largely limited to Thailand, Vietnam, and
Cambodia," wrote the authors, who reported no conflicts of interest in
preparing the study.
Since late 2003, at least 207 people have been infected with bird flu,
according to cases confirmed by WHO. Most, if not all, of those people
fell ill after coming into contact with infected birds. Of those cases,
115 have been fatal. But scientists fear that the virus could quickly
mutate into a form that passes easily among humans, igniting a pandemic
that could kill millions world-wide.
*Write to *Nicholas Zamiska at nicholas.zamiska@wsj.com
<mailto:nicholas.zamiska@wsj.com>^6
--__--__--
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