Important note: Information in this article was accurate in 2003. The state of the art may have changed since the publication date.
South African Press Association (Johannesburg) - 2 August 2003
Earlier in the day, the Treatment Action Campaign said it was consulting lawyers on the matter.
Sapa, in a statement, noted "with grave concern" the decision of the Medicines Control Council of South Africa (MCC) to reject the results of a Ugandan study.
The study focused on the use of Nevirapine in the reduction of risk of mother-to-child transmission of HIV.
"The executive committee of Sapa believes the efficacy and safety of Nevirapine usage, as part of a strategy for the prevention of transmission of HIV from mother to child, has been adequately established beyond reasonable doubt," Sapa said.
Sapa said the rollout of the prevention of mother-to-child transmission programmes (PMTCT) in South Africa -- including the provision of Nevirapine -- had already saved "many hundreds or perhaps thousands of infant lives".
Sapa warned that any disruption of these programmes would have tragic effects.
"We believe that failure to continue to administer Nevirapine at this time would constitute a dereliction of the ethical duties of individual health care professionals as well as an unconstitutional abdication of responsibilities of our health authorities.
"We appeal to the MCC to immediately repeal their decision that is out-of-step with the extensive reviews and statements of authoritative bodies such as the US National Institutes of Health, the US Federal Drug Administration and the World Health Association.
"We urge our members in the field to follow their conscience by utilising the accepted practice of providing Nevirapine as part of the PMTCT programme. In doing so they will dramatically and significantly lower the risk of transmission of HIV from mother to child and thus prevent most cases of childhood Aids," Sapa said.
The MCC said on Thursday it might withdraw permission for the use of Nevirapine on the grounds that it was unhappy with the Ugandan trials on which registration was based.
It gave manufacturers Boehringer-Ingelheim 90 days to provide information proving the drug's safety and effectiveness.
But the TAC said in a statement that all publicly available data on short-course nevirapine used for MTCT prevention indicated it was safe and effective.
"If the MCC has information to the contrary, it must make this available because of the public interest in this issue. In the meanwhile the TAC will seek legal opinion from its lawyers on how to proceed on this matter."
TAC, which 16 months ago won a High Court order forcing the government to implement a rollout of ARVs to pregnant mothers, said the MCC had played "political games" with the registration of nevirapine since 1999.
"The MCC has not provided the public with any new scientific information to support its inexplicable position," the TAC said.
"The recent work of the MCC to register generic ARVs including Nevirapine is being undermined by its fork-tongued approach."
Nevirapine was not the only drug that can be used to reduce mother-to-child HIV transmission. AZT was more effective, but it was also slightly more expensive and complex.
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