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06/02/08

SOUTH AFRICA:  Indian Firm Gets Nod to Import AIDS Drug


Merck Sharpe & Dohme (MSD), the South African subsidiary of pharmaceutical giant Merck, has granted licenses to two Indian firms to import generic versions of its AIDS drug efavirenz.

About 70 percent of patients in the government's free treatment program receive efavirenz as part of first-line therapy. When South Africa issued its first AIDS drug tender three years ago, MSD was the sole supplier of efavirenz. The drug was the most expensive antiretroviral procured in the contract.

Late last year, the AIDS lobby group Treatment Action Campaign accused MSD of anti-competitive practices since it had granted only one license to a generic drug maker, Aspen Pharmacare. TAC noted the license terms were restrictive, blocking Aspen from co-packaging generic efavirenz with other drugs or including it in combination treatments.

Since then, MSD has issued a second license to Adcock Ingram, a local generic manufacturer. The two new licenses were issued to local operations of Aurobindo and Enalani subsidiary Cipla-Medpro. MSD has also allowed generic firms to sell efavirenz as co-packaged or combination pills. MSD's competitors may sell generic efavirenz in both the public and private sector, and they may export the drugs to neighboring countries including Angola, Lesotho, Botswana, Madagascar, and the Democratic Republic of Congo.

MSD's actions have prompted TAC to withdraw its complaint from the Competition Tribunal, said Jonathan Berger, a senior researcher with the AIDS Law Project, which acted on behalf of the activists. "We now have four competitors on the market to MSD on terms that we are largely satisfied with," he said.


Source: Business Day (South Africa):: Tamar Kahn; Courtesy of the CDC National Center for HIV, STD, and TB Prevention