U.S. TRADE NEGOTIATIONS WITH THE SOUTH AFRICAN CUSTOMS UNION UNDERMINE ACCESS TO MEDICINES AND VIOLATE U.S. LAW

Brook Baker
Health GAP
July 7, 2003


On November 4, 2002, United States Trade Representative Robert B. Zoellick formally notified Congressional leaders of the Administration's intent to initiate negotiations for a free trade agreement with the nations of the South African Customs Union: Botswana, Lesotho, Namibia, South Africa and Swaziland. With respect to intellectual property rights, the negotiations would:

To meet "standards of protection similar to that found in U.S. law," SACU nations would be required to limit compulsory licenses to national emergencies or to governmental, non-commercial use only. They would be required to bar parallel trade, to extend patent monopolies for administrative delays, and to link drug registration rights to patent status. Finally these nations would be required to enhance protections for clinical trial testing data by providing five years of data exclusivity, thereby precluding registration of medicines produced under compulsory licenses, and to adopt criminal enforcement for patent violations, including improvidently granted compulsory licenses. In sum, the proposed negotiation objectives would completely eviscerate the Doha flexibilities, dramatically increase IP protection, and shamefully reduce access to more affordable generic products.

More particularly, in the context of the production-for-export problem left unresolved in paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, the SACU negotiations could be disastrous. For example, in another regional trade negotiation, the Free Trade Area of the Americas, the U.S. is the presumed sponsor of a troubling bracketed provision that would explicitly prohibit compulsory licensing for export (8.64 (6) (b)).

PhRMA, the U.S. trade association for the proprietary pharmaceutical industry, has been very explicit that it seeks this export ban in South Africa saying: "The USG should seek to limit the scope of Government use authority to exclude the possibility of Government use for the purpose of export, or for sale to the general public." (PhRMA 2003 Annual 301 Report to the USTR, p. 71). Basically, PhRMA and the USTR, by limiting compulsory licenses to national emergency and public non-commercial use, seek to prevent exports except where there has been an anti-trust violation. (Note: in this regard, there is a pending case in South Africa before the Competition Commission challenging excess pricing and other anti-competitive conducts by GlaxoSmithKline and Boehringer Ingelheim and seeking, among other remedies, non-exclusive compulsory licenses.)

If this no-export ban were imposed on SACU nations, then South Africa would be prevented from being a supplier of standard quality generic medicines to other SACU nations or to the subcontinent as a whole. Since regional and international production-for-export of generic medicines is necessary for countries with little or no efficient manufacturing capacity, excluding one of the few technically competent Africa producers would be a huge blow to sourcing affordable AIDS medicines. Thus, any effort by U.S. SACU negotiators to sabotage pro-public health interpretations of TRIPS that would otherwise permit the most rational, pro-public health solution to countries obtaining exported, low-cost medicines is morally and legally unacceptable.

These intellectual property objectives in SACU negotiations directly violate the principal negotiating objectives in the Trade Act of 2002, which requires the U.S. " to respect the Declaration on the TRIPS Agreement and Public Health, adopted by the World Trade Organization at the Fourth Ministerial Conference at Doha, Qatar on November 14, 2001." 19 U.S.C. 3802(b)(4)(C).

Similarly, by seeking TRIPS-plus provisions found in U.S. law, the U.S. Trade Representative is also directly violating Executive Order 13155, which in relevant part, reads:

(a) In administering sections 301-310 of the Trade Act of 1974, the United States shall not seek, through negotiation or otherwise, the revocation or revision of any intellectual property law or policy of a beneficiary sub-Saharan African country, as determined by the President, that regulates HIV/AIDS pharmaceuticals or medical technologies if the law or policy of the country: (1) promotes access to HIV/AIDS pharmaceuticals or medical technologies for affected populations in that country; and (2) provides adequate and effective intellectual property protection consistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) referred to in section 101(d)(15) of the Uruguay Round Agreements Act (19 U.S.C. 3511(d)(15)).
Activists in Southern Africa and in the U.S. must unite to beat back this illegal and largely clandestine effort by U.S. government to subvert access to lowest cost generic medicines, medicines essential to reverse the tide of HIV inundating entire communities.

WHAT YOU CAN DO

Activists in the U.S. can contact Robert Zoellick, U.S. Trade Representative and the White House to condemn efforts to include heightened intellectual property protections in the SACU negotiations. The text of any such message might state the following or a variation thereof:

"In trade negotiations with the South African Customs Union, the U.S. Trade Representative and the White House should desist from proposing or imposing any intellectual property terms whatsoever. In particular, the negotiators should refrain from limiting the grounds for compulsory licensing, restricting parallel importation, extending patent terms, linking drug registration to patent status, or limiting rights to export under a compulsory license. Instead the U.S. should recognize the rights African countries have under the TRIPS Agreement and the Doha Declaration on the TRIPS Agreement and Public Health to utilize multiple flexibilities to access affordable medicines to address the AIDS pandemic and other public health concerns."

This message can be mailed to Zoellick at the address below or emailed as indicated.

United States Trade Representative
600 17th Street, N.W.
Washington, DC 20508
United States of America
contactustr@ustr.gov

Activists in the South African Customs Union can similarly contact their trade representatives demanding that they unite to oppose including heightened intellectual property protections in the Free Trade Agreement and can also write letters to U.S. consular officials protesting the U.S. IP trade objectives. The same message above, or one adapted to local circumstances, might be used.


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