AIDS activists win battle, drug war continues

Abstract

AIDS activists claimed victory last week when the South African Medicines Control Council (MCC) advised it would grant limited approval for generic fluconazole. But further delay over the approval of nevirapine for mother-to-child transmission of HIV met with protests from doctors during World AIDS Day on Dec. 1. The Treatment Action Campaign (TAC) said on Nov 30 that prescription of Biozole--generic fluconazole smuggled from Thailand by TAC--WO WOMENuld be allowed once the drug had passed quality assessment. The Section 21 approval for use in public-health emergencies is restricted to Cape Towns Brooklyn clinic and prescribers will have to be registered with the MCC. TAC believes the approval will open the way for manufacturers to register generic drugs. However a donation of patented fluconazole (Diflucan) by Pfizer announced on Dec 1 is widely thought to have influenced the MCC to decide against wider availability of Biozole. TAC asserts that many HIV-1-infected South Africans will not benefit from the donation because the offer is restricted to public hospitals and clinics and to the treatment of cryptococcal meningitis. On Dec 1 thousands of medical staff protested outside Chris Hani Baragwanath Hospital in Soweto over the governments failure to provide antiretroviral regimens to affected pregnant women. Boehringer-Ingelheim manufacturers of nevirapine were told last week that their drug was “approvable” for this indication once outstanding questions were answered. In-country marketing director John Heath said he hoped for approval within the first few months of 2001. Boehringers 5-year free drug donation program for vertical HIV transmission has been accepted in Senegal and the Republic of Congo but a decision cannot be made in South Africa until nevirapine is registered. (full text)