Brand-Name Price Gouging

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 pledge.