Wall Street Journal Examines Obstacles of Gilead’s Program To Increase Access to Antiretrovirals in Developing Countries
The Wall Street Journal on Friday examined some of the obstacles facing Foster City, Calif.-based Gilead Sciences' program to increase access to its antiretroviral drug Viread at reduced costs for HIV/AIDS treatment programs in developing countries (Hamilton, Wall Street Journal, 6/30). The company in December 2002 announced that it would offer Viread, known generically as tenofovir, at cost to all African nations and 15 other developing countries through its Gilead Access Program. The initiative allows qualified programs to purchase the drug at a lower price. Gilead later expanded the program to 97 developing countries, and in August 2005 the company announced it would lower the prices of Viread and its antiretroviral Truvada by 31% and 12%, respectively, for the access program. The company said the not-for-profit price of a 30-day supply is $17 for Viread and $26.25 for Truvada (Kaiser Daily HIV/AIDS Report, 2/9). According to the Journal, Gilead has been "snarled" in a number of "bureaucratic snafus and miscalculations," that have delayed the program's widespread implementation. As a result, some HIV/AIDS advocates have "vilified" the company for "basking in good publicity while dragging its feet." Gilead officials "admit many mistakes in conceiving their access program," the Journal reports. One of the problems is the company's attempt to "sidestep" the process of attaining regulatory approval for Viread in developing countries, according to the Journal. The company instead made the drug available through "import waivers," which require clinics and nongovernmental organizations to petition their governments for special permission to import the drug, allowing Gilead to ship it from the U.S., according to the Journal. Only 13 of the 97 countries covered by Gilead's expanded program have approved Viread through this mechanism. Some nations are unwilling to grant the waivers and others insist on separate applications for every HIV-positive person treated with the drug, the Journal reports. Another obstacle came when health authorities in many nations "balked" because the drug was not on the World Health Organization's list of essential medicines, which is considered more useful than FDA approval by many nations, according to the Journal. Gilead last year missed the deadline to get the drug on the list, compounding the problem, according to the Journal. In addition, there are further delays because Gilead has produced an "export version" of the drug to prevent not-for-profit versions from being sold in major commercial markets. Gilead in 2005 sought and received special FDA approval for the export version, which is identical to Viread except the pills are white instead of pale blue, the Journal reports. Even if the "bureaucratic hurdles are overcome," it is still "not entirely clear how much Gilead's access program will help the poorest nations," according to the Journal. Viread continues to be more expensive than a generic triple combination antiretroviral treatment available throughout the developing world, the Journal reports (Wall Street Journal, 6/30).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.