Nevirapine legal battle looms

2003-08-01 10:35

Cape Town - The Treatment Action Campaign says it may take legal action over the Medicines Control Council's threat to deregister nevirapine.

The MCC says it may withdraw permission for use of the drug in preventing mother-to-child transmission (MTCT) of HIV on the grounds that it is unhappy with the Ugandan trials on which registration was based.

It has given manufacturers Boehringer-Ingelheim 90 days to provide information proving the drug's safety and effectiveness.

However, 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.

TAC said it had for a long time called for hospitals and clinics to begin using more effective regimens than short-course nevirapine.

- SAPA