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S Africa Court Orders Distribution of Anti-AIDS Drug - 2002-03-25

For the third time, a South African high court has ordered the government to distribute a key anti-AIDS drug to HIV-positive pregnant women.

Pretoria High Court Judge Chris Botha has again ordered the government to make the anti-AIDS drug Nevirapine available to HIV-positive pregnant women at all state-run hospitals with the capacity to distribute it.

The judge refused to allow the government to appeal against his earlier court ruling regarding distribution of the drug.

Nevirapine can keep a pregnant woman with HIV from passing the virus on to her baby during childbirth. Currently, only a few public hospitals in South Africa can prescribe Nevirapine as part of a pilot program.

Earlier this month, Judge Botha ordered the government to expand its program to all public hospitals as soon as possible. The government said it planned to appeal that decision, and it wanted to delay expanding the program until the Constitutional Court rules on the matter.

But in his latest decision, Judge Botha has again ruled health officials must begin dispensing Nevirapine immediately, while they go through the appeals process.

The Treatment Action Campaign and two other AIDS activist groups filed the original lawsuit aimed at forcing the government to prescribe Nevirapine. TAC spokesman Mark Heywood welcomed the court's latest ruling. "I think that the repeated statements of the judge on the need to give this medicine make for a very strong case on behalf of all those children who are being infected today and will be infected tomorrow, to sue this government in future for its failure to comply with an order that could have saved enormous suffering and that could have prevented HIV infection," he said.

It is still not clear how the government will respond to the court ruling. Health Minister Manto Tshabalala-Msimang told reporters she will consult with the Health Department's legal advisers before deciding how to proceed.

In the past, she has argued that the court is trying to set government policy, which she said should not be allowed.

AIDS activists and some political analysts are alarmed by statements that the health minister made on South African public television Sunday. Ms. Tshabalala-Msimang was asked point-blank whether the government will comply with a court order to distribute the drug. She indicated it may not, telling a reporter "I think the courts and the judiciary must also listen to the regulatory authorities, both from this country and the United States."

"So are you saying no?" asked the journalist.

"Yes and no. I am saying no," she replied.

The situation has been complicated by recent news regarding a study on Nevirapine conducted in Uganda. The drug was approved for use in South Africa partly based on the results of the Ugandan study. But U.S. officials now say there were irregularities in the Ugandan study, and South African authorities say as a result they may have to re-evaluate Nevirapine's registration as a legal drug.

U.S. and World Health Organization officials both say the problems with the Ugandan study are only technical, and do not affect the efficacy or safety of the drug itself.

Despite that, the health department's lawyers last week tried to introduce the issue into the Nevirapine court case. They argued the government should not have to expand its Nevirapine program as long as there are questions about the drug's license. But Judge Botha has also ruled that possible future changes in Nevirapine's registration are irrelevant to the case at hand. Right now, he says, the drug is legal in South Africa.