Compounding the problem of limited technical expertise to implement TRIPS flexibilities in many developing countries is the political pressure exerted on these countries to prevent them from using the flexibilities, or worse, to pressure them to enact "TRIPS-plus" legislation and measures. Political pressure can be either internal or external. Internal pressure generally comes from dominant multinational pharmaceutical companies operating in local markets directly or through their agents. These companies generally have vast resources which are used not just to lobby governments but also to conduct massive marketing campaigns aimed at undermining the exercise of TRIPS flexibilities.47 For example, a statement on the website of the pharmaceutical industry association claims that "independent studies have shown that claims that patents are a barrier to access to medicines are unfounded and inaccurate".48
47 For a flavour of what these companies tell countries see the website of the pharmaceutical industry association whose South African branch had sued the South African government over the use of TRIPS flexibilities http://www.ifpma.org/Issues/issues_intell.aspx.
But more often than not, the political pressure is external, emanating from developed country governments, particularly the United States government. Such pressure takes various forms. One form is bilateral trade agreements that have intellectual property components. For example, both Vietnam and Cambodia entered into bilateral trade agreements with the United States that contains intellectual property requirements including compliance with TRIPS standards when these countries were not members of the WTO.49 Thus, both Vietnam and Cambodia provide that any compulsory licence issued shall be used predominantly for the domestic mar-50,51 A more recent example is the agreement between the United States and the Central American Countries which, among other things, includes provisions for the extension of patent term to compensate for delays, limits the grounds for revoking patents, and introduces rules for pharmaceutical and agricultural chemicals market exclusivity and test data protection that go way beyond the TRIPS requirements.
49 Item Nos. 1 and 2, Questionnaire on Intellectual Property Protection in Vietnam and Cambodia, answered by Le and Le Intellectual Property Attorneys, 8 April 2003.
50 Item 6(d), Questionnaire on Intellectual Property Protection in Vietnam, answered by Le and Le Intellectual Property Attorneys, 8 April 2003.
51 Items 6(d) and 6(g), Questionnaire on Intellectual Property Protection in Cambodia, answered by Le and Le Intellectual Property Attorneys, 8 April 2003.
The second form of pressure is unilateral trade pressures such as under Section 301 of the United States Trade Act.52 In the case of medicines, the office of the United States Trade Representative (USTR) bases its assessment and grading on information supplied by the pharmaceutical industry.53 Countries such as Argentina, Brazil, China, Colombia, Egypt, Hungary and India were on the 2001 Special 301 Priority Watch List for reasons relating to pharmaceuticals and patent protection.54
52 Although, the U.S. can not impose sanctions on the basis of this section without a WTO ruling, Special Section 301 provisions deal with the protection of intellectual property rights abroad and provide for a range of country listings, remedies and possible investigations to "persuade" other nations to yield to U.S. demands and views. The range of country listings includes a "Priority Foreign Country List", a "Priority Watch List", a "Watch List" and a "Special-Mention Category", with each listing triggering a particular course of investigation and possible remedies or actions. For further discussion see Vivas-Eugui (2003), p. 7.
53 Bailey (2001).
54 2001 Special 301 Report, available at http://www.ustr.gov/reports/2002/special301-report.PDF, visited on 22 September 2003.
The third form of external pressure is the threat of filing a complaint at the WTO. Argentina and Brazil are the most recent targets of this mode of TRIPS-plus pressure. Although the United States Government subsequently withdrew its WTO complaint against Brazil’s "local working" requirement due to adverse public opinion, it has continued to pressure Brazil through bilateral channels. The United States Government uses these mechanisms to push developing countries into enacting TRIPS-plus legislation, or to discontinue the exercise of TRIPS flexibilities. It requires a significant level of political and economic clout for individual governments to resist the pressure.55
55 See Okediji (2004).