Kenyan AIDS Advocates Mount Legal Challenge To Allow Country To Make, Import Generic Antiretrovirals
AIDS advocates in Kenya along with the Consumer Project on Technology, a not-for-profit group started by consumer advocate Ralph Nader, are preparing to mount a legal challenge to allow the country to make and import generic antiretrovirals, London's Guardian reports. Cosmos, a Kenyan pharmaceutical company, has already produced generic antiretroviral drugs, and other Kenyan pharmaceutical companies are boosting their capacity to produce such drugs in expectation of a court victory. Cosmos has followed World Health Organization guidelines, successfully copying the branded antiretroviral drugs and registering them with national health authorities. However, the drugs have been sitting in storage because international patent law dictates that the manufacturing company must first obtain a license for the drugs from the patent holders. "There is nothing preventing me [from] mass producing. We have the expertise, the access to raw materials, the registration," Prakash Patel, chair and managing director of Cosmos said, adding, "By the end of the year we will be producing. I think we will be the first to produce ARVs in Africa." Laboratory & Allied, another Nairobi firm, said that it has the capacity to switch to antiretroviral drug production within weeks.
The distribution of generic antiretrovirals has been stalled because Western pharmaceutical companies have refused to grant licenses for generic copies. Such threats have "receded" due to a World Trade Organization declaration that states that developing countries can override patent protections to produce or import generic versions of drugs to combat public health crises, according to the Guardian (Carroll, Guardian, 5/21). However, U.S. negotiators in February refused to sign a deal under the Doha declaration unless wording was included to specify which diseases constitute a public health epidemic (Kaiser Daily HIV/AIDS Report, 4/2). In addition, the drug industry has fought to protect its interest in the drugs by cutting prices, depicting generic drugs as unsafe and warning health ministers that treatment programs could bankrupt their budgets. John Musunga, commercial director of GlaxoSmithKline's Nairobi office, said that the firm has no plans to stop the production of generic antiretrovirals in the country, although a document advocating a campaign to promote doubt in the efficacy of generic drugs was pinned to the wall of his office, according to the Guardian. Regardless, a "series of victories" for generic antiretroviral drugs, including gaining the support of President Bush, have contributed to a sense of "optimism" among Kenyan pharmaceutical companies (Guardian, 5/21). Bush in his State of the Union address in January unveiled a five-year, $15 billion plan to fight HIV/AIDS in Africa and the Caribbean, including plans to provide generica formulations of antiretroviral drugs to two million people (Kaiser Daily HIV/AIDS Report, 1/30). The House and the Senate have approved a bill (HR 1298) meant to implement Bush's initiative. The House gave final approval to the bill yesterday and sent it to Bush, who is expected to sign it (Abrams, Associated Press, 5/21).