The TRIPs Agreement lays down minimum standards for the protection of intellectual property, including operative and procedural rules to ensure the enforcement of rights. No Member may grant protection that is less than the levels laid down nor be obliged to give more extensive protection. The Agreement must be implemented according to the domestic laws of each country; it does not directly establish rights for individuals, these derive from the form and extent of its implementation8.
8 This means that the Agreement is not «self-executory» and that its application requires the transposition of its rules into rules of domestic law. See in this connection CASADO and CERRO, 1994.
The Agreement explicitly recognizes that, in formulating or amending domestic laws and regulations, Members may «adopt measures necessary to protect public health... provided that such measures are consistent» with the Agreement's provisions (Article 8).
The question of patentability and exceptions thereto was one of the major areas of negotiation of the TRIPs Agreement9. From the beginning of the Uruguay Round, it was obvious that one of the essential aims of the industrialized countries, particularly the United States, was to extend patentability to pharmaceutical products globally.
9 The text of the section on patents has been analyzed in CORREA (1994). See CASADO and CERRO (1994) for an overall analysis of the Agreement.
When the Round began, many countries did not confer protection on pharmaceutical products. Nevertheless, during the period which elapsed between the commencement of the Round in 1986 and its conclusion in 1994, this situation changed radically.
Some developing countries embarked upon economic restructuring and redefined their relations with industrialized countries, especially with regard to direct foreign investment. Changes in intellectual property were seen as components of a new framework for such relations and for attracting foreign capital.
In the majority of cases, however, changes in intellectual property law corresponded more to demands coming from outside than to endogenous motives. Many developing countries were subjected to strong pressure to amend their patent legislation exerted by the lobby of multinational pharmaceutical companies. The United States Government included intellectual property issues in its international agenda under the provisions of section 301 of the Trade and Tariffs Act (amended in 1988)10. Many developing countries, including Brazil, Argentina, Thailand and Indonesia, have been the subject of investigations or trade reprisals under this section.
10 See DESTLER (1992) for an analysis of how this section is applied.
From 1986 onwards, a new orientation in economic policy and a vigorous campaign by the United States combined to reduce substantially the number of countries which refused to grant patents in specific areas, especially in the field of pharmaceuticals. In South Korea, Indonesia, Thailand, Mexico, Chile, Bolivia, Colombia, Ecuador, Peru, Venezuela11, El Salvador, Taiwan and China «inter alia» patent legislation was amended to this effect.
11 In the case of the last five countries mentioned, it should be noted that the Common Industrial Property Regime applicable to them (Decision 344 of October 1993) does not allow pharmaceutical products which appear on the World Health Organization's list of essential drugs to be patented [Article 7.e)]. Although this list, which is periodically revised, usually includes drugs whose patents have expired, it may also contain drugs for which patents have been granted.
Pursuant to the TRIPs Agreement, three of the major pharmaceutical markets in developing countries (Argentina, Brazil and India) find themselves in this situation and will have to amend their patent legislation (within the time limits laid down in the Agreement)12.
12 This is also the case for Egypt, Pakistan, Uruguay, Paraguay and Turkey