WOZA Internet (Johannesburg) - March 5, 2001
Johannesburg - Government is concerned that poor people's
access to quality medicines is dependent on the goodwill of
individual industry players. With the Medicines and Related
Substances Control Amendment Act of 1997 - now tied up in a
court battle initiated by the pharmaceutical industry -
government wants to ensure its ability to provide medicines for
all, for ever.
The latest SA Health Review 2000 - launched last Thursday -
confirms that drug expenditure puts an unsustainable burden on
state coffers as the HIV/AIDS pandemic claims more and more
victims, and contributes most significantly to the inequality
in access to healthcare between the private and public sector.
"Public sector sales are expected to make up 24%, which
translates to R59.36 per person not belonging to a medical aid
scheme. In contrast, the per capita expenditure on prescription
drugs in the private sector would be R800.29," according to the
The total value of drug sales is anticipated to be R8.25
billion, according to figures released to the SA Health Review
Team by the Pharmaceutical Manufacturers Association.
Background to the court case Health Director-General Dr Ayanda
Ntsaluba said in a press briefing at the weekend that he took
part in the 1993 health expenditure analysis which found
government was making a disproportionate allocation to drugs.
This, says Ntsaluba, culminated in the now disputed Act.
In January 1998, Zuma met with the pharmaceutical industry,
represented by the Pharmaceutical Manufacturers Association.
"The PMA was creating the impression that government willingly
disrespects international trade laws, which is not true," says
He says government offered the PMA to take those sections of
the Act it had a problem with and make a first formulation of
the regulations based on the Act. Instead, he says, government
received a court interdict.
"You must remember that the pharmaceutical companies are the
ones that took us to court, and accusations that three years
have been wasted since the Act was passed in November 1997 is
their fault, not government's," says Ntsaluba.
Govt not willing to budge on policy issues He says that the
policy issues at stake here are not negotiable. "We believe we
operate within international laws and frameworks, which are by
the way putting developing countries at a disadvantage," he
"We asked them to drop the court case and participate in a team
to sort out 15c, but our offer was turned down."
Ntsaluba was not prepared to answer iClinic's question of how
much the court case was costing the SA tax payer.
He denied that government had not taken up any drug offers.
"The main offer was that of fluconazole from Pfizer - we
reached agreement last December, the MCC fast-tracked its
registration and the first shipment will reach SA by the end of
"We also got an offer at the 13th International AIDS Conference
in Durban last year from Boehringer Ingelheim, of nevirapine.
This drug was already registered, but not for the use in
mother-to-child transmission of HIV, so the offer was a bit
premature - we can't accept a donation of an unregistered drug.
The MCC has now approved it and the first shipment has arrived
"GlaxoSmithKline made an offer of AZT, but nevirapine is much
cheaper," he says.
He says the PMA makes the argument that government has not even
made a tender and is therefore not serious about
"This is just not true. For example, we have been on a tender
with fluconazole - no one had responded with an affordable
offer. AZT is also on tender, but still not affordable," he
He also referred to arguments that the Patents Act is an
existing mechanism for ensuring affordable drugs but that it is
underutilised for some unknown reason.
"The activation of the Patents Act can be done by the state or
any citizen - the responsibility lies therefore with the public
too. We are in discussion with the department of trade and
industry abut it. SA takes a very strong point on access to
affordable medicines," says Ntsaluba.
Government not 'killing the goose that lays the golden egg' He
refutes PMA's argument that the Act "will kill the goose that
lays the golden egg" - in other words, the alleged abrogation
of patent rights the Act is said to be leading to will
demotivate companies to continue spending money on research and
"We are not saying we don't recognise the importance of
research and development. We are saying the benefits of science
and technology should be used more to benefit the poor who need
it most. This actually drives many individual scientists: to
find treatments that will help the sick and the dying.
"The PMA can't claim they are a major investor in research and
development - some of their R&D is subsidised by governments
and universities," concluded Ntsaluba.
Analysis of the top 12 drug manufacturers in America in 1999
showed that their median percentage of revenue dedicated to
research and development was 12,4%, whereas a median of 34,3%
was dedicated to marketing and administrative costs. Chief
executive officers of the top 10 firms averaged R80 million
each in salaries in 1999.
After the court case . . .
If government wins, Ntsaluba says they will speed up the
publication of regulations and the provisions of the Act will
kick in as soon as possible.
"The provision of general substitution [of patent drugs with
cheaper generics] is not going to be subject to long
bureaucratic processes such as is the case with the
registration of medicines.
"If we lose - and it is hard to understand why we should - we
hope that the areas of problems in interpretation are clearly
pointed out so we can correct them."
Meanwhile, 5 000 sick South Africans will be alive at the
beginning of the week-long hearing and dead by the end of it,
according to Phil Bloomer of Oxfam.
"12 000 people will have become newly infected with the HIV
virus during the same week, 1 400 of them babies. This is the
catastrophe facing the people of South Africa."
The agency notes that, during the same week of the court case,
the five biggest companies involved in the trial will have sold
R17.6 billion worth of medicines and made R4.44 billion profit.