E-DRUG: South Africa publishes draft Parallel Import Regulations
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[The court case victory of 19 April in South Africa allowed the
Government to proceed with the Medicines Act (Act 90, 1997).
As the act is an enabling Act, the Regulations have to provide
the details.
The text of the draft Regulations has been published 1 June in the
Government Gazette. According to SA law, everyone can comment
during the next 3 months. The text is available at:
http://www.hst.org.za/doh/default.asp
Besides the Regulations, one can also download the Clinical Trial
Guidelines and other DOH documents there.
Act 90 (1997) is available at:
http://www.parliament.gov.za/acts/1997/act90.pdf
Below a comment on the Regulations from Kaiser Daily HIV/AIDS
Report, published at: http://www.kaisernetwork.org
NN]
Drug Access
South African Government Issues First Draft of Legislation Allowing
Importation of Discounted Pharmaceuticals
Following the withdrawal of a pharmaceutical industry lawsuit
against South Africa's 1997 Medicines and Related Substances
Control Act, the South African government has issued a 70-page
draft of legislation that would "allow it to shop around for the
cheapest drugs, particularly those that can treat infections
associated with AIDS," the Washington Post reports (Washington
Post, 6/5). The lawsuit filed by 39 drug firms had stalled the
enactment of the 1997 legislation, which would allow for "parallel
importation," in which patented drugs can be "acquired on the
international market, instead of from local, more expensive
suppliers." The withdrawal of that suit has paved the way for the
law's implementation. The draft would require anyone wishing to
import patented drugs into South Africa to apply for a permit from
the health minister. If the permit is granted, the importer must
then apply to register the drug with South Africa's Medicine
Control Council. Once approved, the patent-holder in South Africa
"would then be unable to block the drug's importation and dis-
tribution," allowing South Africa to look for the cheapest medicines.
These parallel import licenses would be valid for up to a year, but
could be renewed (Cohen, Associated Press, 6/4). South African
Health Minister Manto Tshabalala-Msimang said that the
government tried to balance its "international responsibilities in
terms of the TRIPS provision with [its] central objective of
accessing more affordable medicines to benefit our people"
(Swindells, Reuters, 6/4). The TRIPS agreement permits a country
to enact national laws permitting the use of a patented product
without authorization of the patent-holder under certain specified
circumstances, such as declaration of a national emergency
(Kaiser Daily HIV/AIDS Report, 3/16). Tshabalala-Msimang added
that the "interested parties," including the drug industry, have
three months to respond to the draft (Reuters, 6/4). After public
hearings are concluded, the health department will then "make
changes it deems necessary" and the regulations will become
public law (AP/Salt Lake Tribune, 6/5).
Antiretrovirals Still Out of Reach
Although the law will allow South Africa to import a variety of dif-
ferent pharmaceuticals, AIDS activists and South African health
officials say that the health ministry will likely focus on medicines
treating AIDSrelated opportunistic infections rather than antiretro-
virals. Health department spokesperson Jo-Anne Collinge said,
"Antiretrovirals are still expensive. They are beyond the budget of the
health department." Health experts said that South Africa "could
not expect great savings on shopping around for antiretrovirals as
the price differentials set by the drug firms were not that great,"
adding that "only" compulsory licenses would "sufficiently drive" down
the cost. Collinge said that the government will likely aim to import
antibiotics that treat oral thrush and respiratory problems, as well
as medicines for malaria, tuberculosis and STDs (Reuters, 6/4).
The Kaiser Daily HIV/AIDS Report is published for
kaisernetwork.org,
a free service of The Henry J. Kaiser Family Foundation, by National
Journal Group Inc.c 2001 by National Journal Group Inc. and Kaiser
Family Foundation. All rights reserved.
Contact Daily Reports Staff
Tel: +1-202-672-5952
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