South African Judge Denies Government Request to Appeal Recent Execution Order Mandating Provision of Nevirapine

South African High Court Judge Chris Botha today denied a government request to appeal a recent execution order mandating that the government provide nevirapine to HIV-positive pregnant women while its appeal of a previous court order to provide the drug is pending, the South African Press Association reports. Health Minister Manto Tshabalala-Msimang and seven provincial health ministers on Friday asked Botha to grant them a certificate permitting them to appeal to the Constitutional Court Botha's executive order to provide the drug (South African Press Association, 3/25). The execution order, issued March 11, stated that the government could appeal to the country's Constitutional Court a December High Court ruling mandating that it provide nevirapine to all HIV-positive pregnant women through its public health facilities. However, the order added that the government must provide nevirapine to HIV-positive pregnant women through all public health facilities "with the capacity for testing and counseling" while the appeal to the first order is pending (Kaiser Daily HIV/AIDS Report, 3/11).

Questions About Safety
The government on Friday applied for a certificate to approach the Constitutional Court to appeal the executive order, citing a recent letter by South Africa's Medicines Control Council that addressed some safety concerns surrounding nevirapine. The letter, which was addressed to Tshabalala-Msimang, stated that the U.S. FDA had "alerted" the MCC to problems with the reporting and documentation of a study conducted in Uganda to test the efficacy of Viramune, the brand name under which nevirapine is marketed (see story 7). Marumo Moerane, an attorney for the South African government, said that the MCC might decide to de-register nevirapine and that "in the light of this development, the health authorities had to exercise extreme caution in administering" the drug. The Treatment Action Campaign, the South African AIDS group that filed the original lawsuit against the government to provide nevirapine, on Friday then filed a counter-application to prevent the government from appealing the execution order, arguing that the possibility that nevirapine may be de-registered "should have no effect on the government's obligation to provide it" to pregnant women (South African Press Association, 3/22). Botha upheld his earlier ruling today, saying that he did not want to see any "unnecessary" loss of life while the appeal against the original court order proceeded. "In essence I had to balance the loss of lives against prejudice that could never amount to more than inconvenience," he explained. Tshabalala-Msimang recently told the South African Broadcasting Corporation that she will not comply with any court order to expand the country's nevirapine program beyond its current 18 pilot sites (Associated Press, 3/25).