Baggrund om AIDS i SA

Update on AIDS in South Africa

Background

Almost 5 million people in South Africa are living with HIV/AIDS.
It is estimated that 70,000 HIV-positive children are born in South Africa every year. Up to one-third of HIV-positive mothers pass the virus to their babies. The rate of
mother-to-child-transmission (MTCT) of HIV can be significantly reduced through the use of anti-retroviral drugs, and Nevirapine is one of the cheapest and easiest to use. Medical studies have shown that the provision of one tablet of Nevirapine to the mother at the onset of labor, and another dose to the baby up to 72 hours after birth, can reduce the risk of vertical transmission of HIV by 50%.
The use of Nevirapine is supported by the World Health Organization and UNAIDS. The drug is being offered to developing countries for free for five years by its manufacturer, Boehringer Ingelheim.

Court case on Treatment Access
In August 2001, AIDS activists from Treatment Action Campaign (TAC), the Children's Rights Centre and Save Our Babies took the government of South Africa to the High Court in Pretoria. They claimed that the government was acting unconstitutionally by failing to provide Nevirapine to all HIV-positive pregnant women in order to reduce the rate of transmission of the virus to their babies. TAC and its co- applicants challenged the government's
decision to provide Nevirapine to pregnant women at only in a
small number of pilot sites, and they were suing to have the program accelerated.

The government defended its position stating that the gradual introduction of the drug was more responsible, and that it was necessary to do more research on Nevirapine to ensure its safety.
The government was offering HIV-positive pregnant women access to
Nevirapine at only 18 test sites, claiming that it could not implement a nationwide program until the results from the test sites became available, which would be the end of 2003 at the
earliest. The government also challenged the right of the High Court to rule on government policy decisions, based on the separation of the powers of the state and the judiciary.

The ruling: On December 14, 2001, Judge Botha ruled in favor of the AIDS activists, ordering the government to make Nevirapine available all over the country as soon as possible. Judge Botha said "About one thing there must be no misunderstanding: a
countrywide MTCT prevention program is an ineluctable obligation
of the state". Specifically, the ruling ordered the government to
produce a time-tabled roll-out plan to provide HIV-positive pregnant women access to Nevirapine at all state health facilities with the capacity to do so, and where this was medically
indicated. The court set the government a deadline of March 31,
2002 for launching a comprehensive national MTCT plan.

Recent Developments

* Court case - Following the December judgement, the South African
government requested leave to appeal the ruling to the Constitutional Court. Granting leave to appeal would usually suspend the original ruling. Therefore, in response TAC went to
court seeking a "compulsion order" (or an "execution order"), which would force the government to obey the original ruling pending the constitutional appeal.

In early March 2002, Judge Botha simultaneously granted the
government leave to appeal to the Constitutional Court, and acceded
to TAC's request for a compulsion order. This meant that the government should provide Nevirapine in terms of the earlier order, outside the existing pilot sites, pending the outcome of
the appeal to the Constitutional Court. Therefore, for example, if state health facilities that had the capacity to do so failed to provide Nevirapine where medically indicated, the relevant minister of health would be in contempt of court. Last week, the government appealed against the decision and the interim compulsion order.
This appeal was presented at the High Court in Pretoria on Friday,
March 22. TAC presented a counter-application, attempting to
prevent the government's appeal of the compulsion order.

On May 2 and 3, the Constitutional Court will consider whether to
hear the appeal against the original order by Judge Botha. If the
Constitutional Court hears the case, judgement is unlikely before
late June, and that decision will be binding.

* Several Provinces Defy the National Government: As the court case
continues, several South African provinces have defied the
government's restrictions on the provision of Nevirapine to
pregnant women to help protect their babies from contracting the
HIV virus. During the court case last year, KwaZulu-Natal pulled
out of the defense (the government side), stating that it intended
to provide universal access to Nevirapine. The Western Cape has
been accelerating its program towards the provision of Nevirapine
at all public health facilities. Gauteng, which is
ANC-controlled, announced in February 2002 that it was expanding
access beyond the 2 pilot sites, and that its provincial hospitals
will provide Nevirapine to all pregnant women infected with HIV.

* The MCC and Nevirapine: On March 20, the Medicines Control
Council (MCC) - the South African equivalent of the FDA - indicated
that it is considering reviewing the registration of Nevirapine,
following reports of irregularities in documenting the results of
NIH-sponsored trials of the drug in Uganda two years ago. The MCC
addressed a letter to the South African Minister of Health
Tshabalala-Msimang, saying that it had been contacted by the U.S.
FDA, which expressed concern at the findings earlier this month of
irregularities in a study on the use of Nevirapine to prevent MTCT
of the HIV virus in Uganda. The MCC said it was seeking further
information from the NIH, the FDA and the pharmaceutical company
Boehringer Ingelheim, but would have to review the drug in light of
these concerns and may ultimately decide on its de-registration in
South Africa. Nevirapine was registered for use in
mother-to-child-transmission prevention in South Africa last year.

The SA Health Minister said on March 21st that the irregularities
being investigated by the NIH and the FDA were proof that Africans
are "being experimented on", and that Nevirapine is unsafe.
Nathan Geffen at TAC commented to Africa Action that TAC is very
concerned that the Health Minister is trying to capitalize on this
latest development as a pretext to withdraw Nevirapine's South
African licence at the MCC, thus sabotaging the entire legal
process in which the government and TAC are engaged. He said
that the issues with Nevirapine from the Ugandan trials were based
on inadequate documentation rather than any problems with the
drug or research study. The NIH, WHO, and UNAIDS have all issued
statements reaffirming that Nevirapine is indeed safe and
effective.

* ANC Backs the Government's AIDS Policy: Following a three-day
meeting of the party's National Executive Committee, at which
former President Mandela urged the accelerated provision of
anti-AIDS medicines, the ANC on March 20 declared its support for
the government's controversial go-slow approach to the provision
of anti-retroviral treatment. The executive committee of the ANC
also said it was only an "assumption" - not a known scientific
fact - that HIV caused AIDS, but it said government policy should
proceed on that assumption, at least for now. On March 21, Health
Minister Tshabalala-Msimang articulated this position, stating
that the government's response to AIDS is based on the premise
that HIV causes AIDS.

* Top SA Scientists Pressure Government on Nevirapine: In a
Declaration published in the British Medical weekly The Lancet on
Saturday, twenty-two of the leading members of South Africa's
scientific and medical community say that the scientific evidence
in favor of the drug Nevirapine is incontrovertible, and they call
on the South African government to distribute the drug to
HIV-positive pregnant women without delay. This increases
pressure on the government just ahead of the March 31 deadline for
launching a program to prevent mother-to-child-transmission of
HIV.

* SA Trade Unions call for the Provision of Nevirapine: The
Congress of South African Trade Unions has reiterated its view
that antiretrovirals should be provided by the government to
HIV-positive women.