E-drug: US law and South African law on essential medicines
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Info-Policy-Notes | News from Consumer Project on Technology
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April 7, 1999
US law requires US Department of State to seek
repeal of South African law on essential medicines
Vice President Gore plays key role in dispute
I found the following provision buried in last year's 423,911 word
appropriation bill. This legislation requires the US government to seek the
repeal, suspension or termination of legislation in South Africa that
authorizes parallel imports and compulsory licensing of medicines. These
are mechanisms
the government of South Africa is trying to use to obtain less expensive
pharmacuetical drugs to combat a health care disaster. According to the US
Department of State, the author of this provision is Rep. Rodney P.
Frelinghuysen (R-NJ).
How bad are things in South Africa?
It is estimated that 3.2 million South Africas are HIV positive, including a
staggering 45 percent of the military. One in five South African pregmant
women test positive for HIV.
In the face of this horror, the US Congress and the Clinton/Gore
Administration is determined to prevent South African from using its rights
under international law and the WTO/Gatt agreement to obtain cheaper sources
of essential medicines.
This is the provision in the US appropriations bill:
<---------------------Excerpt from PL 105-277---------------->
*Public Law 105-277
105th Congress
An Act
Making omnibus consolidated and emergency appropriations for the fiscal
year ending September 30, 1999, and for other purposes. <<NOTE: Oct. 21,
1998 - [H.R. 4328]>>
Be it enacted by the Senate and House of Representatives of the United
States of America in <<NOTE: Omnibus Consolidated and Emergency Supplemental
Appropriations Act, 1999.>> Congress assembled,
[snip]
Provided further, That none of the funds appropriated under this heading may
be made available for assistance for the central Government of the Republic
of South Africa, until the Secretary of State reports in writing to the
appropriate committees of the Congress on the steps being taken by the
United States Government to work with the Government of the Republic of
South Africa to negotiate the repeal, suspension, or termination of
section 15(c) of South Africa's Medicines and Related Substances Control
Amendment Act No. 90 of 1997:
[snip]
<------------------End Excerpt from PL 105-277---------------->
The disputes over the South African legislation have been focused on two
issues, parallel importing of drugs, which would permit South Africa to seek
the cheapest world price for a drug (a practice that is common in England
and other members of the European Union), and compulsory licensing.
Under compulsory licensing, which is permited by the World Trade
Organization under Article 31 of the TRIPS agreement on intellectual
property, South Africa can issue a compulsory license for AIDS drugs like
AZT, ddI or ddC, if it follows certain safeguards, and pays a government set
royalty to the patent owner. For some drugs this reduces the price by 70 to
95 percent, depending upon manufacturing costs. Several of the drugs that
are candidates for compulsory licensing, including AZT, ddI and ddC, were
developed by the US
National Institutes of Health (NIH).
Vice President Gore plays a large role in this dispute, as the US Chair of
the US/South Africa Binational Commission (BNC). According to the Vice
President Gore's staff, on every occasion that Vice President Gore has meet
with Thabo Mbeki, his South African counterpart, Gore has pressed South
Africa on the
intellectual property issues relating to pharmaceuticals. The Gore/Mbeki
commission is considered a key instrument to pressure South African not to
use compulsory licensing of HIV/AIDS drugs.
For more information about this issue, see
http://www.cptech.org/ip/health
http://lists.essential.org/pharm-policy
http://www.cptech.org/march99-cl
For the pharmaceutical industry perspective, see the PhRMA 301 submission to
the United States Trade Representative (the document the US Department of
State has been providing to AIDS groups who ask about US policy.)
http://www.phrma.org/issues/nte/safrica.html
Jamie Love <love@cptech.org>
Consumer Project on Technology
202.387.8030
http://www.cptech.org
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