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Manto's refusal to provide
drug 'unconstitutional'
25/03/2002 12:27 - (SA)
Pretoria - Health Minister Manto Tshabala-Msimang's statement that she would not heed a court order to supply nevirapine to HIV-positive pregnant women beyond the existing pilot sites was a violation of the Constitution, the Treatment Action Campaign said on Monday.
He was referring to a statement by the minister who, when asked in an interview on SABC television whether government would heed the court order, said the "judiciary cannot prescribe from the bench".
"We need a clear statement from the highest level of government (on) whether the court and court orders will be respected," TAC secretary Mark Heywood said outside the Pretoria High Court.
Judge Chris Botha on Monday upheld an application by the TAC, the Children's Rights Centre and paediatrician Haroon Saloojee of the Save Our Babies organisation, confirming his earlier order that government should provide nevirapine to HIV-positive pregnant women at state hospitals with the capacity to do so, and where it was medically indicated.
Botha initially granted an order in December last year. In March, he granted the government a positive certificate allowing it to ask the Constitutional Court to hear its appeal against the December order. At the same time, Botha issued an execution order, compelling the government to make nevirapine available outside the existing pilot sites where the drug is being tested, pending the outcome of the Constitutional Court bid.
Tshabalala-Msimang and seven health MECs (of all provinces except the Western Cape and KwaZulu-Natal, where nevirapine programmes have already been expanded past the pilot sites) on Friday applied to Botha to grant a positive certificate to take their appeal against the execution order to the Constitutional Court.
However, Botha issued a negative certificate on Monday. He said the matter of the execution order, unlike the original order, was not a constitutional matter. "I must add I am also not convinced that another court will find that I have exercised my discretion incorrectly. In essence I had to balance the loss of lives against prejudice that could never amount to more than inconvenience."
According to figures before court, the execution order could save at least 10 lives a day.
"In the end the choice was between tolerating the loss of life and tolerating inconvenience, no matter how many lives were at stake," Botha said.
De-registration a crucial issue
In the hearing, Marumo Moerane, SC, for the government, argued that the possible de-registration of nevirapine by the Medicines Control Council (MCC) was a crucial issue in the matter.
In a letter last week, the MCC alerted Tshabalala-Msimang 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. Botha said in his judgment: "In my view the fact that there may be a revision of the registration of nevirapine is irrelevant."
Such a possibility had existed throughout the case. "Until that happens, there is no reason to review the order or to discontinue the work at the pilot sites.
"What is conspicuous, is that the respondents have not produced any evidence, after almost a year of dispensing nevirapine to approximately one tenth of the affected population, of any deleterious effects encountered in its programme," Botha said.
'Yes and no'
In the SABC television interview, Tshabalala-Msimang was asked if government would be prepared to follow a court order to roll out its nevirapine programme in light of concerns about the drug.
"My own view is that the judiciary cannot prescribe from the bench and that we have a regulatory authority in this country that is interacting with the regulatory authority FDA of the United States and I think we must allow them to assist us in reaching conclusions."
Asked whether the government would stand by the court's decision, the minister said: "No, I think the courts and the judiciary must also listen to the authorities - regulatory authorities - both from this country and the United States."
Asked if she was saying no, Tshabalala-Msimang said: "Yes and no. I'm saying no."
Reacting to this, Positive Women's Network director Prudence Mabele, who has lived with HIV for 10 years, on Monday said: "I get so frustrated by our own government depriving us the right to live."
Heywood said all major health bodies in the world supported the drug. These included the Centres for Disease Control, the World Health Organisation, the United Nations Aids programme and the American National Institute for Health.
"There is no question about its safety and efficacy," Mabele said. "I know many HIV-positive women who have HIV-negative children because of this drug." Heywood said the judge's statements made for a strong case for patients and doctors to sue the government for failure to provide the medication and to prevent enormous suffering.
- SAPA
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