SEVENTY-percent of babies born in the State sector to HIV-positive mothers did not need the antiretroviral nevirapine, the Constitutional Court heard on Thursday.
This was because only 30% of these babies were born HIV-positive or became HIV-positive.
”You are giving a drug to 70% who do not need it. And you are introducing a drug of which you do not know the long term effects” said Marumo Moerane, SC for the State.
Moerane was arguing the government’s appeal against a Pretoria High Court judgement ordering the national Health Department to make the drug available to all HIV-positive pregnant women at state hospitals, where medically indicated and where the women have been tested and counselled.
He said pilot sites were initially necessary because the long term effects of nevirapine were not known. He agreed that the government’s decision not to give it out flew in the face of a World Health Organisation study which concluded that the positive benefits of a range of antiretrovirals, including nevirapine, ”greatly outweighed” any possible adverse effects.
The study also concluded there was no need to restrict the use of the drug to pilot sites.
Moerane said this was because the long term effects of the drug had not been considered by the study.
Justice Richard Goldstone replied that one dose was needed for a mother and one for a child, and asked: ”What is the relevance of long term toxicity?” There was no answer.
Justice Kate O’Regan pointed out that the study did, in fact, refer to one study on the long term effects of nevirapine.
Moerane is to argue after lunch on whether the original Pretoria High Court order infringed the principle of separation of power between the government and the judiciary.
He said the Treatment Action Campaign’s initial application last year had come too soon, while the government was still involved in trying the drug out via test sites.
The pilot studies would have shown the potential costs of a full nevirapine program and its potential impact on the other services provided by the national health department.
”It is the nature of a pilot programme to exclude those not within (it) and it is acceptable to introduce a new intervention via a pilot program,” he said.
Moerane also argued earlier in the day that no nevirapine should be provided without a full service to the patient, including testing, monitoring, the provision of milk formula and other services.
In December Judge Chris Botha granted an application in this regard by the TAC, the Children’s Rights Centre and paediatrician Dr Haroon Saloojee of the Save Our Babies campaign.
The judge ordered the government to extend its existing nevirapine programme of two pilot sites per province.
He also instructed government to draw up a comprehensive national programme to prevent or reduce MTCT of HIV, including the provision of voluntary counselling and testing, and where appropriate, nevirapine or other medicine, and formula milk for feeding.
The government had to report back on its progress with the plan by March 31 this year.
After the judgement was delivered, government applied for leave to appeal to the Constitutional Court. Botha granted the leave. At the same time he granted an application by the TAC and the two other applicants for an execution order.
That meant that pending the Constitutional Court appeal the government had to provide nevirapine for HIV-positive women in state hospitals where it was medically indicated and where testing and counselling could be done.
The government also asked the Constitutional Court to overturn the execution order, but was refused. The court said it would give reasons for its ruling after this week’s hearing, where the appeal against the original order is to be heard.
The government contends that the original order infringes the principle of the separation of powers. It also maintains that its MTCT programme is consistent with its constitutional obligations. The pilot projects are intended to help understand the operational demands of running a successful programme and to research the safety and efficacy of the drug and whether it promotes the development of drug-resistant strains of HIV.
As its knowledge expands and resources allow, government will extend the programme to other public hospitals. The TAC opposes the appeal, saying that even without feeding supplements or other interventions, nevirapine reduces the risk of MTCT of HIV.
The issues the Constitutional Court will have to decide on, include: whether the original Pretoria High Court orders constitute making policy on behalf of government and if so, whether that violates the separation of powers; whether the government’s programme comply with its constitutional obligation to take reasonable measures, within available resources, to progressively realise the right to health care, including reproductive health care; whether the existing programme discriminates against those pregnant women and their babies who are dependent on public health care and are unable to go to an existing access point for treatment as opposed to those who are able to do so; whether it results in discrimination against the poor, and indirectly against black women, given that private doctors may generally prescribe nevirapine where medically appropriate, but doctors at state hospitals outside the pilot sites may not do so; whether it is a breach of the constitutional rights of the child, including the child’s right to life and basic health care; and whether the programme violates certain other constitutional rights, such as the rights to life and dignity and the right to make decisions concerning reproduction. – Sapa