Clinton Foundation, Global Fund, World Bank, UNICEF Extend Low-Cost Generic AIDS Drug Prices to More Than 100 Countries
The William J. Clinton Presidential Foundation on Tuesday announced an agreement with UNICEF, the World Bank and the Global Fund to Fight AIDS, Tuberculosis and Malaria to extend the discounted prices it negotiated last year for antiretrovirals for 16 countries to more than 100 developing countries, the AP/Atlanta Journal-Constitution reports (Koppel, AP/Atlanta Journal-Constitution, 4/6). The Clinton Foundation's HIV/AIDS Initiative in October 2003 secured a deal with generic drug makers Ranbaxy Laboratories, Cipla, Matrix Laboratories, Hetero Drugs and Aspen Pharmacare to reduce the cost of commonly used three-drug antiretroviral regimens to 38 cents per patient per day, down from the already discounted price of 55 cents per patient per day; the lowest available price of the same three-drug regimen using brand-name antiretrovirals is $1.54 per patient per day (Kaiser Daily HIV/AIDS Report, 11/21/03). In addition, the foundation in January reached agreements with medical technology companies Beckman Coulter, Becton, Dickinson & Co., Roche Molecular Diagnostics, Bayer HealthCare and bioMerieux to cut the prices of viral load and CD4+ T cell diagnostic tests -- which help doctors determine when to begin administering antiretroviral drugs and whether the drugs are working -- in developing nations by as much as 80% (Kaiser Daily HIV/AIDS Report, 3/25).
The Clinton Foundation agreement originally applied to only 16 nations in Africa and the Caribbean (AFP/Sunday Times, 4/6). Under the new agreement, the pricing program will be available to the more than 100 countries that receive aid from the World Bank, Global Fund and UNICEF. The program draws on the "complementary strengths" of the organizations, such as the Global Fund and World Bank's monetary resources, the Clinton Foundation's negotiating powers and UNICEF's experience with procuring drugs, assessing demand and creating distribution channels, the Washington Post reports (Vedantam, Washington Post, 4/6). Fixed-dose combination, or FDC, antiretrovirals will be available at about $140 per person per year, about one-third to one-half of the cost of the lowest price currently offered (Fox, Reuters/Globe and Mail, 4/6). The governments of each country will be responsible for purchasing the drugs or outsourcing this task to procurement agencies, including UNICEF. Some countries -- including South Africa and China -- will use their own funds to purchase the drugs, while most of the other countries will rely on donor funding to procure the drugs (Joint statement, 4/6). In order to secure the discounted prices, the countries must guarantee payment and install secure drug distribution channels to prevent the reimportation of the drugs into rich nations (AP/Atlanta Journal-Constitution, 4/6). In addition, entities other than the drug companies must agree to bear the costs of registering the drugs in each country, "which might include lobbying [governments] or fighting patent lawsuits," Cipla Chair Yusuf Hamied said, according to the New York Times.
It was "unclear" on Monday "whether the ambitious plan would be realized," the Times reports. When news of the agreement leaked on Friday, two Cipla executives said they had not been consulted about the expansion of the program from the 16 original countries, according to the Times. Hamied said that the company sells its combination drug in 59 countries for between $240 and $280 per patient per year and was unwilling to expand the number of markets where it sells the drug for $140 until it has "something in writing." He added, "That doesn't mean I don't intend to participate. I want to know more." A Ranbaxy spokesperson said it could not yet confirm whether the company would participate, according to the Times. Stavros Nicolaou, vice president for trade development at Aspen, said that the company would sell its first-line antiretroviral drugs -- including a two-drug combination pill and a one-drug pill -- for about $140 a year only in Africa. Matrix CEO Prasad Nimmagadda said that his company, which supplies raw materials for the drugs, would be willing to expand its capacity. The other companies could not be reached for comment, the Times reports. Anil Soni, chief adviser to the Global Fund executive director, said it was a "mistake on our part" to announce the deal before ensuring that the suppliers were in agreement, but they wanted to "make clear to our recipients that it is possible to purchase" high-quality generics. Clinton Foundation HIV/AIDS Initiative Chair Ira Magaziner said that it would "take time" to bring all of the participants into the agreement, according to the Times.
The agreement's endorsement of generic drugs is "politically delicate" because the Bush administration has not allowed U.S. funding to be used to buy the generic FDC drugs, the Times reports (McNeil, New York Times, 4/6). Officials from HHS, the World Health Organization, UNAIDS and the Southern African Development Community last week in Gaborone, Botswana, met to discuss U.S. concerns over the safety, effectiveness and approval process for certain generic drugs used to treat HIV/AIDS in developing countries. Provisions in the President's Emergency Plan for AIDS Relief -- which seeks to provide treatment to two million HIV-positive people living in 14 African and Caribbean countries -- in principle require drugs to be approved either by FDA or through a mechanism established by PEPFAR. U.S. officials have questioned whether the WHO voluntary drug screening process through which the generic FDC antiretrovirals were evaluated is thorough enough and want to ensure that the drugs will not contribute to the development of drug-resistant HIV strains through widespread or improper distribution and use of the medications (Kaiser Daily HIV/AIDS Report, 3/31). Soni said that the organizations would "welcome" U.S. involvement in the Clinton Foundation program, provided that the U.S. government agrees to allow the use of the fixed-dose generic antiretrovirals, according to the Post (Washington Post, 4/6). Magaziner said that the foundation was "not looking to criticize the U.S. government" (Lueck, Wall Street Journal, 4/6).
"Clearly, when you have the power, the imprimatur and the dollars of the Clinton Foundation, World Bank, UNICEF and Global Fund weighing in behind generics, the debate is over," U.N. Special Envoy for HIV/AIDS in Africa Stephen Lewis said, adding, "These four bodies make it clear ... that brand-name companies are free -- indeed invited -- to tender and to meet the low prices. But it's equally clear that huge numbers of African lives will be prolonged and saved by generics" (AP/Atlanta Journal-Constitution, 4/6). Lewis added that the deal "could well spell the turnaround of the HIV/AIDS pandemic in Africa" (Toronto Star, 4/6). ActionAid said that although the prices negotiated by the foundation are the lowest ever, they are still "far beyond the reach [of] individuals and governments in the poorest countries" (BBC News, 4/6). "With these agreements, we are one step closer to making sure future generations can live without the scourge of AIDS," former President Bill Clinton said, adding, "We are hopeful that developing countries and those who support them in the fight against AIDS will take full advantage of this agreement and act quickly to do all they can to help in this fight" (AFP/Sunday Times, 4/6).