E-DRUG: USA PEPFAR, abortion, sex workers and ARVs
[The details of the "Bush AIDS" fund (officially named the "Presidents
Emergency Plan For AIDS Relief" or in short "PEPFAR") are becoming clearer.
Besides demanding receivers of PEPFAR money to be against abortion and
commercial sex workers, there are also stiff debates whether the PEPFAR
monies will be used to buy the best and most affordable ARVs.
MSF with 11000 AIDS patients already on treatment in Africa, is heavily
advocating generic fixed dose combinations (see
As big farma does not have FDCs (patents are split over companies; only
generic companies offer such products), a smokescreen of doubtful quality
and efficacy is being launched. For example, the CEO of PEPFAR [Tobias]
said, "We have been reading stories lately about some problems with some
drugs around the world where people with the best of intentions have made
acquisitions of drugs that have turned out to not have the consistency, and
the safety and effectiveness that people had hoped. I think it is very, very
important that we move rapidly but with certainty that we're not endangering
In that process, PEPFAR has refused to accept the WHO pre-qualification
scheme (see http://mednet3.who.int/prequal/default.shtml), and is now
pushing a draft guideline on FDCs for the 29-30 March Botswana meeting (see
E-drug will closely follow the upcoming events. Anybody from the field who
has experience with PEPFAR already? The PEPFAR website (see
http://pretoria.usembassy.gov/wwwhaids.html) is inviting proposals from 1 to
30 million USD; the next deadline is 31 March. If you are against abortion
and commercial sex workers anyway, maybe something for you?
The article below crossposted with thanks from IP-HEALTH. Copied as fair
Brand-Name Price Gouging
Dara Colwell, AlterNet
March 17, 2004
Viewed on March 19, 2004
After a year's delay in funding, the Bush administration's
five-year, $15 billion global AIDS initiative has finally been
unveiled. Two weeks ago, the 99-page report of the President's
Emergency Plan for AIDS Relief was submitted to Congress, and U.S.
Global AIDS Coordinator Randall Tobias hit the forum circuit,
discussing future strategy. As part of that strategy, 55 percent of
the Plan's total funds will be earmarked for treatment, with 75
percent of that amount reserved solely for the provision of
antiretroviral (ARV) drugs -- the cocktail therapy that helps keep
AIDS patients alive.
Lacking in the discussion, however, is mention of how current U.S.
trade policies may undermine the ability of developing countries --
those in urgent need of medicine -- to expand their access to ARVs.
According to international humanitarian organization Doctors Without
Borders, the U.S. has exercised stringent intellectual property
protections in bilateral and regional trade negotiations to curtail
generic competition -- leaving the poverty-stricken developing
countries that often have the highest number of AIDS cases in the
lurch. "This is an immediate concern for us," says Rachel Cohen, US
Director of Doctor's Without Borders Campaign for Access to
Essential Medicines. "When it comes to trade, health is always at
the bottom of the agenda."
The trade pacts include the Free Trade Area of the Americas (FTAA)
draft, currently under negotiation, US-Central American Free Trade
Agreement (CAFTA), finalized last December, and trade deals with the
South African Customs Union, Thailand and Morocco. Under CAFTA,
Costa Rica, El Salvador, Guatemala, Honduras and Nicaragua will be
obliged to extend pharmaceutical patent terms beyond the 20 years
required in World Trade Organization (WTO) rules. Proposed FTAA
provisos include a five-year delay for small generic companies using
test results completed by brand-name competitors, and restrictions
on compulsory licensing -- which allows governments to authorize
themselves or a third party to produce generic medicine without the
patent holder's approval.
"The consequence will be very clear," says Cohen, who finds the
restrictions worrisome. Both agreements, she says, undermine the
Doha Declaration on the Trade-Related Aspects of Intellectual
Property Rights (TRIPS), which explicitly prioritized public health
over profit. "There will be thousands of needless deaths every year
because the drugs are too expensive."
Over the past few years, generic competition has ensured sustained
price reduction, dramatically driving down costs from $10,000 to
roughly $300 per person per year. From 2000-2002, Oxfam
International conducted research on the price of brand name drugs in
Uganda and discovered that prices fell by as much as 97 percent over
two years. The largest decreases were for Stavudine/ D4T, which fell
from $173 in May 2000 to $6 in April 2002. In Latin America, which
has 1.9 million HIV cases of 42 million total worldwide, countries
have relied heavily on generic drugs to save lives. For example,
Brazil's free AIDS drug program has treated more than 110,000
HIV-positive people with primarily generic medicines. Mortality
rates have dropped by over 60 percent.
Lack of generic competition can lead to market monopolization, which
inevitably hurts developing countries. One such example is that of
Merck & Co, which patented Stocrin (efavirenz, EFV), an
antiretroviral recommended by the World Health Organization for
treatment. ERV comes in a 600mg combination formulation, which
enables patients to take one tablet a day, or 200mg capsules, taken
three times. As yet, Merck has not registered the fixed dose
combination in low and middle-income countries, despite promises to
do so in 2002. Because virtually no generic competition for ERV
exists, countries such as South Africa must pay for each individual
drug -- the only formulation available -- hiking costs 44 percent
higher, according to Doctors Without Borders. On March 3, the
organization renewed its calls for Merck to stop backsliding on its
In terms of the President's 5-year strategy for AIDS relief,
Ambassador Tobias has remarked that the government's policy will be
to buy safe, effective drugs at the lowest possible price. "Now, if
those happen to be drugs that are manufactured by generic companies,
fine; if those are drugs that are manufactured by brand name
companies, fine," Tobias said during a briefing at the U.S.
Department of State's Bureau of Public Affairs. However, Tobias,
former chairman and CEO of Eli Lilly, might be swayed by brand name
lobbying when it comes to allocating spending.
Tobias has plans to meet with the Food and Drug Administration and
other regulatory bodies in the upcoming month, to discuss drug
safety and efficacy standards. "I think there's a real possibility
that the issue of price affordability is going to become less of an
issue," he said during a Q&A session at an American Enterprise
Institute forum February 5, later adding, "If we can get effective,
safe products that are going to work, we're going to buy them."
Tobias' words are not something Asia Russell, co-coordinator for
international policy at Health GAP, is willing to bank on. Health
GAP is a U.S.-based activist organization focused on increasing
developing counties' access to AIDS treatment. "Bilateral plans are
turning into a slush fund for Big Pharma," said Russell, who spoke
from Zimbabwe, where she was attending a regional AIDS conference.
Russell said attendees were "extraordinarily angry" at the U.S.'s
efforts at political arm-twisting in trade talks. "It's hypocrisy.
The Bush Administration is exploiting the issue of the AIDS pandemic
to cast a worthy glow. But it's denying countries the right to
obtain what makes sense -- drugs at lower cost and maximum
While Tobias has spoken broadly about intellectual property
concerns, Secretary of Health and Human Services Tommy Thompson has
openly defended the U.S.'s tough pro-IP stance. "We're going to
protect intellectual property rights," Tompson said during the
American Enterprise Institute forum. Tompson stated the
pharmaceutical industry had a corporate responsibility to offer low
prices, yet he remained adamant that he wasn't willing to "stifle
the innovation of pharmaceutical companies" to create new drugs.
The industry's interest in safeguarding its tremendous investment is
unmistakable. The U.S. pharmaceutical industry, including the
International Intellectual Property Alliance, a coalition of six
U.S. trade groups, has asked for the "highest levels of protection"
under the FTAA. Repeated phone calls to the IIPA went unreturned.
The outcome of regional negotiations has already shown how powerful
the U.S. has been in forcing the hand of developing countries to
accept restrictive measures that curtail WTO requirements. In 2003,
Guatemala modified its national intellectual property bill to
consent to a standard of five years exclusivity on pharmaceutical
test data, effectively blocking the entry of low cost generics.
"There's no question the government has been very reluctant for
developing countries to have access to generics," says Mark
Harrington, executive director of Treatment Action Group, an
organization that advocates for efficient research efforts for AIDS.
Harrington believes this is further exacerbated by finance and trade
ministers, with little knowledge of AIDS issues, who negotiate away
certain rights under pressure. "Ministers of Health and certainly
sick people are not part of that decision-making process," adds
Sharonann Lynch of Health GAP. "The U.S. has quadrupled the number
of trade negotiators signing on to talks. It's no secret they
negotiate aggressively for what they want."
Harrington believes the issue is not only one of intellectual
property protection, but "a matter of where U.S. dollars are being
spent," and this raises a valid point. The generic cost for six-dose
combination ARV therapy at two pills a day runs about $270 per
patient per year, according to a price guide published by WHO and
DWB. This cost could drop much lower for certain eligible countries
-- to $132, a price reduction secured by the Clinton Foundation.
Separate drugs sold from a brand name company, however, cost $562.
Examining market alternatives to ensure the lowest possible cost may
prove the key to saving more lives -- a stated goal of the Bush
Administration. And with the President's commitment of $15 billion
of the American public's money to address the global AIDS pandemic,
where tax dollars ultimately go remains a fundamental issue. "If you
pay brand name prices you'll keep one person alive," says Cohen.
"But if you use bio-equivalent, quality medicine produced by generic
manufactures that meet international standards set by the WTO, you
will keep three people alive at current prices."
Dara Colwell is a freelance writer based in Brooklyn.
© 2004 Independent Media Institute. All rights reserved.
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