South African government issues first draft of legislation allowing importation of discounted pharmaceuticals

Following the withdrawal of a pharmaceutical industry lawsuit against South Africa’s 1997 Medicines and Related Substances Control Act, the South African government has issued a 70-page draft of legislation that would “allow it to shop around for the cheapest drugs, particularly those that can treat infections associated with AIDS,” the Washington Post reports (Washington Post, 05/06).

The lawsuit filed by 39 drug firms had stalled the enactment of the 1997 legislation, which would allow for “parallel importation,” in which patented drugs can be “acquired on the international market, instead of from local, more expensive suppliers.” The withdrawal of that suit has paved the way for the law’s implementation. The draft would require anyone wishing to import patented drugs into South Africa to apply for a permit from the health minister. If the permit is granted, the importer must then apply to register the drug with South Africa’s Medicine Control Council.

Once approved, the patent-holder in South Africa “would then be unable to block the drug’s importation and distribution,” allowing South Africa to look for the cheapest medicines. These parallel import licenses would be valid for up to a year, but could be renewed (Cohen, Associated Press, 04/06). South African Health Minister Manto Tshabalala-Msimang said that the government tried to balance its “international responsibilities in terms of the TRIPS provision with [its] central objective of accessing more affordable medicines to benefit our people” (Swindells, Reuters, 04/06). The TRIPS agreement permits a country to enact national laws permitting the use of a patented product without authorization of the patent-holder under certain specified circumstances, such as declaration of a national emergency ( Kaiser Daily HIV/AIDS Report, 16/03). Tshabalala-Msimang added that the “interested parties,” including the drug industry, have three months to respond to the draft (Reuters, 04/06). After public hearings are concluded, the health department will then “make changes it deems necessary” and the regulations will become public law ( AP/Salt Lake Tribune, 05/06).

Antiretrovirals still out of reach

Although the law will allow South Africa to import a variety of different pharmaceuticals, AIDS activists and South African health officials say that the health ministry will likely focus on medicines treating AIDS-related opportunistic infections rather than antiretrovirals. Health department spokesperson Jo-Anne Collinge said, “Antiretrovirals are still expensive.

They are beyond the budget of the health department.” Health experts said that South Africa “could not expect great savings on shopping around for antiretrovirals as the price differentials set by the drug firms were not that great,” adding that “[o]nly” compulsory licenses would “sufficiently … driv[e]” down the cost. Collinge said that the government will likely aim to import antibiotics that treat oral thrush and respiratory problems, as well as medicines for malaria, tuberculosis and STDs (Reuters, 04/06).