[e-drug] South Africa publishes draft Parallel Import Regulations

[e-drug@usa.healthnet.org]

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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mailto:dailyreports@kaisernetwork.org
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