South African Press Association (Johannesburg) - March 22, 2002

Gilbert Marcus, SC, for TAC, referred to a letter by the MCC to Health Minister Manto Tshabalala-Msimang alerting her to serious concerns which the United States' Food and Drug Administration (FDA) had expressed about a nevirapine test conducted by a US institution in Uganda.

According to the letter, dated Wednesday, questions had been raised about the reporting and documentation of the study on the use of Viramune (of which nevirapine is the active ingredient) for the prevention of mother-to-child-transmission of HIV.

The MCC said it would review nevirapine in the light of those developments. Marcus said TAC hoped that when considering the matter of nevirapine's registration, the MCC would also take account of the view of the World Health Organisation (WHO) regarding its safety and efficacy.

The WHO was of the opinion that there was no need to confine the use of nevirapine to the 18 pilot sites in the country, he said.

TAC also hoped the MCC would take note of research done on the matter in a project at Khayelitsha in the Cape Peninsula, Marcus said.

In December last year, Judge Chris Botha granted an application by TAC, paediatrician Haroon Saloojee of the organisation Save Our Babies, and the Children's Rights Centre for an order forcing the government to make nevirapine available to HIV-positive pregnant women at all state facilities with the capacity to do so and where it was medically indicated.

Earlier this month, Botha issued a certificate allowing the government to ask the Constitutional Court to hear its appeal against the order. At the same time, Botha granted an application by TAC for an execution order.

The latter order meant that the government had to provide nevirapine outside the pilot sites pending the outcome of its possible Constitutional Court appeal.

Tshabalala-Msimang and seven health MECs (of all provinces except the Western Cape and KwaZulu-Natal, where nevirapine programmes have already been expanded beyond the pilot sites) on Friday asked Botha for a certificate to allow them to approach the Constitutional Court for permission to hear their appeal against the execution order.

TAC brought an urgent counter-application to prevent that from happening. Marumo Moerane, SC, for the government, argued that the new information about the Uganda study was an indication that the administration of nevirapine should not be allowed outside the pilot sites.

The health authorities must await the outcome of the MCC's investigations into the matter and in the meantime it had to adopt a cautious approach, he said. Botha asked him whether the government would stop administering nevirapine at the pilot sites on the basis of the latest developments.

Moerane answered: "We will certainly do so if the investigations that the MCC conducts in the light of the information of the FDA reveals that there was fraud in the reporting and documentation of that Ugandan study or that information submitted to the MCC on closer analysis and scrutiny was incorrect or, if on the basis of what the MCC will have known by then, they have withdrawn the registration.

"The probabilities are there that the pilot sites will be closed down." At least at the pilot sites there was monitoring and evaluation, Moerane said. "The new circumstances demand caution and limitation to exposure to the drug." He added that the prejudice and harm suffered by other patients who would have to forego treatment because of the cost of giving nevirapine to HIV positive women and their babies was irreparable.

But Marcus said there was no way in which lost life could be restored. "It is quite intolerable to weigh the lives of children up against anything else...

"They deliberately turn a blind eye to the impalatable truth that their opposition to the execution order will result in the sanctioning in the preventable deaths of children and the sanctioning of the psychological devastation of the mothers concerned."

Moerane accused TAC of a "rather alarmist approach" in quantifying the possible number of deaths.

But Marcus said it did not matter whether 10 or one life per day was saved. Conservatively estimated, more than 400 lives could be saved through the execution order, he said.

"The respondents say this is a sacrifice you should endorse. We say it would be unspeakably horrific to do so."

Marcus held that an execution order could not be appealed, but Moerane said there was no such principle.

Moerane said Botha's orders amounted to a violation of the constitutional separation of powers. The judge had made policy decisions for the executive, for which he did not have the authority or the power, he said.

Botha is expected to deliver his judgment on Monday.

The Constitutional Court is to hear on May 2 and 3 the government's request for permission to appeal Botha's original order. If Botha grants their permission to continue with an appeal effort against the execution order, that will be heard at the same time.
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