E-DRUG: Lancet on the SA court case
[The Lancet's report on the court case. Copied as fair use. WB]
The Lancet Volume 357, Number 9258 10 March 2001
News - Science and medicine
Drug firms take South Africa's government to court
Makie Koro is a 20-year-old HIV-infected woman living in the impoverished
township of Kayamandi outside Cape Town in South Africa. Her case
highlights the isolation and tragedy that faces most AIDS patients in
Africa. Last December her 2-year-old son died of AIDS. A few weeks later
Koro was admitted to hospital with tuberculosis. "They said I had AIDS and
there was no treatment not even vitamins. I was sent home to die", she says
Her short time on the ward with patients also afraid and ashamed about
their condition prompted Koro to stand up in her school hall on Valentine's
Day and proclaim in front of her friends and teachers that she had AIDS.
Koro said later that being denied access to antiretroviral drugs because
the government says it cannot afford them has robbed her of her
constitutional right to dignity, life, and health care.
Koro's hopes for treatment rests on the outcome of a landmark court case
that began in Pretoria on March 5 in which 42 multinational drug companies
are suing the South African government. The world's largest pharmaceutical
companies led by the Pharmaceutical Manufacturers' Association of South
Africa (PMA), want the court to block the government from enacting a law
that they say infringes their intellectual property rights. They argue that
protection of their billion dollar drug patents is crucial to their ability
to do business.
The disputed legislation gives the health minister the right to import
generic versions of patented drugs (parallel importation). It also allows
for compulsory licensing whereby generics can be manufactured locally. The
law encourages the generic substitution of medicines that are no longer
under patent; it allows for a pricing committee to review drug costs; and
it streamlines the functioning of the drug regulatory authority. If the
court finds in favour of the government the case could set a precedent that
would affect poor people's access to essential drugs not only in Africa but
also other developing countries.
When Mandela signed the act 3 years ago, the PMA and its members
immediately applied for an interdict to prevent the health minister from
using the law until it had been tested in a court of law. Treatment Action
Campaign (TAC) chairperson Zackie Achmat said that during the 3-year delay,
more than 40 000 people in South Africa have died from AIDS-related
illnesses. These deaths have occurred because most patients did not have
access to the expensive antiretroviral drugs, says Achmat.
On the first day of the case TAC attempted to join the proceedings and give
evidence to highlight the effect of drug prices on HIV/AIDS patients. PMA
immediately contested TAC's application but the court has allowed TAC's
testimony and the case was postponed on March 6 until April 18 to enable
PMA to prepare a response.
Head of the PMA, Mirryena Deeb, told The Lancet that parallel importation
of drugs would undermine the ability of pharmaceutical companies to charge
different prices in different parts of the world. A tiered pricing strategy
allows wealthier countries to subsidise poorer ones, and the drug companies
still get profits they need for research, said Deeb. The act gave the
health minister arbitrary and unconstitutional power and actually
contravened South Africa's patents act, she continued. The PMA has also
stated that the law contradicts the global Trade Related Intellectual
Property Rights (TRIPS) treaty.
The director-general of the South Africa's department of health, Ayanda
Ntsaluba, has said that drug companies have felt threatened. "The latest
figures show that we are about 0·6% of the global market and 1·2% in terms
of value. We are not going to break major pharmaceutical companies. The
issue for them is not South Africa's market. It's the precedent [the case]
sets", he said.
AIDS activists in major cities in countries including the UK, France, USA,
Italy, Germany, and Denmark heeded TAC's call for a day of international
protests against "drug companies' profiteering". After receiving a petition
from protesters in London, the head the Association of the British
Pharmaceutical Industry, Trevor Jones, said that "the problem of ill health
in the developing world is far more complex than simply providing medicines
cheaply. In countries where inhabitants earn less than US$1 a day and
governments are not able to support public health, no price is low enough".
Meanwhile WHO has come out in support of the South African government. WHO
spokesman, Gregory Hartl, said on March 6 that they believed the disputed
law did not violate international rules. "There is latitude within the
TRIPS agreement for getting drugs to Africans much more cheaply than they
are currently getting them", he said.
So far both sides are confident they will win. However it seems that the
"winner" will almost inevitably have to face an appeal by the loser in the
constitutional court. Whatever the outcome, the case will have an effect on
the fate of Makie Koro and the millions of AIDS patients in Africa. Koro
echoes the sentiments recently expressed by Gro Harlem Brundtland, WHO's
director general, in the International Herald Tribune: "To suffer from a
disease with no treatment or cure is tragic. To know that a treatment
exists, but is too expensive, brings the ultimate despair". Sitting in the
tiny shack she shares with 14 others she told The Lancet she asks for her
human rights to be respected: "I want to be treated like a human being with
dignity. I want to feel better and I want to live longer. Wouldn't you?"
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