Kaiser Daily HIV/AIDS Report - Tue, 17 Apr 2001
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Mandela 'Castigates' Drug Companies, Criticizes Government Efforts on
Eve of Resumption of Patent Trial
Speaking Sunday to the South African Broadcasting Company, former
South African President Nelson Mandela "castigated" the Pharmaceuti-
cal Manufacturers' Association of South Africa and the 39 drug firms
it represents in the lawsuit against South Africa's 1997 Medicines
and Related Substances Control Act, Reuters reports. Mandela's com-
ments come days before the trial is set to resume in Pretoria's High
Court. In the hour-long interview, Mandela accused the pharmaceutical
industry of "exploiting" the situation in South Africa and other de-
veloping nations by charging "exorbitant" prices for AIDS medica-
tions. The pricing policies are "completely wrong and must be con-
demned," he said. But he also said that the South African government
had "failed to engage adequately" with the drug companies to negoti-
ate "affordable" prices. Regarding the court case, which resumes to-
morrow after a five-week postponement, Mandela said, "The government
is perfectly entitled, in facing [the HIV/AIDS epidemic], to resort
to generic drugs, and it is a gross error for the companies, for the
pharmaceuticals, to take the government to court." Mandela added,
"[W]e must also take responsibility for not doing sufficient work to
persuade these pharmaceuticals to change their approach." In an "ap-
parent message" to his successor, Thabo Mbeki, whose government has
been accused of "ignor[ing] repeated offers" of donations and price
cuts, Mandela said, "There is nothing as important as a dialogue in
trying to resolve problems. If we have a clear and connected plan to
persuade the pharmaceuticals to settle and to charge prices which are
affordable to the masses of the people, I am sure that the result
would be positive" (Boyle, Reuters, 4/15).
Case History
The 1997 Medicines and Related Substances Act, which would allow the
government to override patent laws and "import, license and produce"
lower-cost generic versions of medications, is in the middle of the
controversy. After the law's passage in 1997, the PMA, representing
39 pharmaceutical companies, filed suit to block the measure's imple-
mentation, claiming it would "put the very future of the pharmaceuti-
cal industry at risk by threatening profits that accrue from the pro-
tection of intellectual property rights" and that support further re-
search and development (Agence France-Presse, 4/15). However, the
government claims that the law is not about patents, but about making
medicines more affordable. Zweli Mkhize, health minister of KwaZulu-
Natal province, said competition is one way to lower prices. "We want
to be independent in those types of decisions and let the industry be
competitive and therefore offer us the best deal that is available in
the market. But the market must be open and allow that possibility to
happen," Mkhize said. Mark Heywood, national secretary of the Treat-
ment Action Campaign, said that drug affordability will "free up"
funds for improving the medical infrastructure needed to deliver com-
plicated AIDS treatments. The lack of medical resources has been
cited by drug companies as one reason price cuts would not make much
of a difference in AIDS treatment in sub-Saharan Africa. "Availabil-
ity would provide an incentive for people to get tested and seek
treatment," he added (Brown, Hartford Courant, 4/15). The PMA says
that the law is making the pharmaceutical industry a "scapegoa[t] for
South Africa's inaction" on HIV/AIDS, adding that infrastructure
problems, hunger and contaminated water are widespread in sub-Saharan
Africa. "When people are angry and dying out there, the government
mustn't accuse us of delaying their treatment," PMA head Mirryena
Deeb said (Picard, Globe and Mail, 4/16).
Legal Maneuverings and Briefs
The resumption of the "landmark court battle" will include the pres-
entation of a friend-of-the-court brief filed by the Treatment Action
Campaign, an AIDS advocacy group and "fierce" critic of the govern-
ment's failure to provide antiretroviral medications (Agence France-
Presse, 4/15). TAC's brief is expected to say that the drug firms
have earned "excessive profits" on AIDS medications, especially in
light of tax breaks they received on their research and the fact that
"key" compounds in many of the drugs were discovered by publicly
funded researchers. "It will be argued ... that the alleged viola-
tions of intellectual property can in no way be said to threaten the
viability of profitability of the research-based pharmaceutical in-
dustry," TAC wrote in papers submitted to the court and obtained by
Reuters. In an affidavit, the PMA counters that the law would give
the health minister "unfettered power" over importing generic medica-
tions in violation of intellectual property laws, without any "real"
savings on cost. If the law were implemented, it would "lead to ge-
neric substitutes" for medicines still under patent protection, "in
violation of the [drug manufacturers'] patent rights, trademark
rights and copyright," the document continues (Swindells, Reuters,
4/16). The affidavit, filed last week, also states that the South Af-
rican government "ignor[ed]" offers of price reductions by the compa-
nies. "(There is) a general unresponsiveness on the part of the gov-
ernment to utilize the offered assistance," the PMA wrote. Boe-
hringer-Ingelheim, one of the claimants in the case, said last week
that it offered the government a donation of Viramune, an antiretro-
viral drug used to reduce the risk of vertical transmission from
mother to child, but the Medicines Control Council has "dragged its
feet" on the offer for more than a year. The affidavit includes exam-
ples of offers made by several companies to South African Health Min-
ister Manto Tshabalala-Msimang, but speaking before parliament she
denied that she ever received those offers and declined to comment on
the case because it was still pending. She also declined to say
whether the government would freely distribute antiretroviral drugs
if it were to win the case (Agence France-Presse, 4/15). Since the
postponement of the trial in March, Merck and Bristol-Myers Squibb,
along with Abbott Laboratories, which is not partaking in the law-
suit, have announced further price reductions (Hartford Courant,
4/15). The hearings are slated to continue until April 25 and a rul-
ing is not expected for two to three months after that time. An ap-
peal by the losing party to the Constitutional Court, South Africa's
highest court, is expected (Reuters, 4/16).
--
Ethiopia to Import AIDS Drugs for First Time
Ethiopia's Ministry of Health announced Monday that for the first
time since the discovery of HIV in the country, it has authorized the
importation of antiretroviral medications to fight the disease,
Reuters reports. The ministry said in a statement that it has drafted
a "detailed list of designated antiretroviral drugs" as a "guide" for
importers and called on firms to import "affordable medicines." The
country, which has 2.6 million residents with AIDS, has "relied" on
public awareness campaigns to curb transmission. An estimated 300,000
of the country's 60 million residents died of AIDS-related complica-
tions in 1999. In total number of HIV/AIDS cases, Ethiopia ranks
third in sub-Saharan Africa behind South Africa and Nigeria (Reuters,
4/16).
--
Cecilia Snyder
mailto:csnyder@ccmc.org
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