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GlaxoSmithKline licenses production of generic AIDS drugs in South Africa

BMJ 2001; 323 doi: (Published 13 October 2001) Cite this as: BMJ 2001;323:828
  1. Susan Mayor
  1. London

    The pharmaceutical company GlaxoSmithKline has granted a voluntary licence to a company in South Africa to manufacture and distribute low cost generic versions of three of its AIDS drugs, on the basis of an agreement announced last week.

    The agreement allows the pharmaceutical company Aspen Pharmacare, the biggest manufacturer of generic drugs in South Africa, to manufacture three AIDS drugs—zidovudine (Retrovir), lamivudine (Epivir), and a combination of zidovudine and lamivudine (Combivir).

    These drugs are currently the most widely used antiretroviral agents in South Africa. Under the agreement, GlaxoSmithKline, the patent holder for zidovudine, and Shire Pharmaceuticals Group, the patent holder for lamivudine, have agreed to waive their rights to royalty payments on these products.

    Aspen will be able to manufacture the drugs in South Africa and distribute them to the South African public sector, and non-governmental organisations, and other charitable organisations accredited by the World Health Organization. The company will pay a 30% fee on net sales of the drugs to non-governmental organisations managing AIDS treatment in South Africa.

    Dr Julia Cleves, chief of policy with UNAIDS (the joint United Nations programme on HIV and AIDS), said: “This is an important milestone in efforts to improve the treatment of AIDS in South Africa. We have been asking the big research based pharmaceutical companies to issue voluntary licences for AIDS drugs. Glaxo has pressed ahead and done that for its AIDS drugs.”

    But she cautioned: “It is too early to judge the impact of provision of generic AIDS drugs to the public sector in South Africa. We don't yet know if the South African government will take up the offer of these cheap drugs.”

    UN figures show that 1 in 9 of the population is infected with HIV, meaning that South Africa has more people with AIDS or HIV infection than any other country in the world. Lisa Power, head of policy with the Terrence Higgins Trust, a UK HIV and AIDS charity, hopes that other companies will follow Glaxo's lead.

    The move is hoped to break the deadlock that has previously existed between pharmaceutical companies and South Africa on the provision of cheap AIDS drugs. It follows the decision six months ago by 39 pharmaceutical companies to halt a legal action to prevent the country from importing cheap drugs.

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