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:

• Seek to establish standards that reflect a standard of protection similar to that found in U.S. law and that build on the foundations established in the WTO Agreement on Trade-Related Aspects of Intellectual Property (TRIPs Agreement) and other international intellectual property agreements, such as the World Intellectual Property Organization Copyright Treaty and Performances and Phonograms Treaty, and the Patent Cooperation Treaty.

• Establish commitments for SACU countries to strengthen significantly their domestic enforcement procedures, such as by ensuring that government agencies may initiate criminal proceedings on their own initiative and seize suspected pirated and counterfeit goods, equipment used to make or transmit these goods, and documentary evidence. Seek to strengthen measures in SACU countries that provide for compensation of right holders for infringements of intellectual property rights and to provide for criminal penalties under the laws of SACU countries that are sufficient to have a deterrent effect on piracy and counterfeiting.

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)).