The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) falls within the ambit of the World Trade Organization (WTO); it is an integral part of the WTO Agreements, which create international obligations among Member States. As such, the TRIPS Agreement is binding on all of the more than 130 WTO Member States, and it is subject to the WTO's mechanism for the settlement of disputes among members. This dispute settlement system, while aimed at assisting the countries concerned with finding mutually acceptable solutions to their disagreements via consultations, may, as a last resort, authorize trade sanctions against a non-compliant Member Country, thus ensuring enforcement of WTO's rules and agreements.
The TRIPS Agreement lays down a number of detailed standards for the protection of intellectual property rights (IPR), which will have to be incorporated in the country's national legislation. These standards relate to copyright and related rights, trademarks, geographical indications, industrial designs, lay-out designs for integrated circuits, protection of undisclosed information (or trade secrets) and patents. Moreover, TRIPS mandates that countries should make arrangements to ensure that intellectual property rights can effectively be enforced within their territory.
With regard to patentability, one of TRIPS' main requirements is that patents shall be available for any invention, in all fields of technology, provided the criteria for patentability (novelty, inventive step and industrial applicability) are met. Thus, TRIPS makes for example the granting of patents for pharmaceutical product and process inventions obligatory, for a minimum period of 20 years10. Since prior to TRIPS, many developing countries did not, or only to a limited extent, grant patents for drugs, these new standards represent a significant increase in protection granted for pharmaceuticals. It is therefore feared that prices of pharmaceuticals in those countries may increase, which is bound to further reduce people's already limited access11.
10 For more detailed information on TRIPS provisions that are relevant for (access to) pharmaceuticals, see for example "Globalization and Access to Drugs", published by WHO Geneva, and "The TRIPS Agreement and Pharmaceuticals", report of an ASEAN Workshop on the TRIPS Agreement and its Impact on Pharmaceuticals, Jakarta, 2-4 May 2000.
11 WHO estimates that a third of the world population lacks regular access to the medicines they need.
More importantly perhaps, the TRIPS standards for IPR protection are largely based on the models for intellectual property protection, which existed in industrialized countries; these models are not necessarily appropriate for developing countries.
However, while TRIPS drastically reduces countries' options and possibilities for developing and enacting suitable IPR legislation, it is important to realize that the Agreement does leave some room for manoeuvre; countries can use this room to design laws that, within the given limits, are in their best interest. Some of the areas where flexibility was built into TRIPS, and which may be relevant in the context of traditional medicine, are:
• the TRIPS standards for protection apply to certain forms of IPR (patents, copyright etc.) only; countries may opt to expand protection into other areas;
• TRIPS allows -and most national laws provide for- the exclusion from patentability of "diagnostic, therapeutical and surgical methods for the treatment of humans or animals". This exclusion, when applied to traditional treatments, is especially important for procedure-based therapies such as acupuncture12;
12 Procedure-based therapies generally lack the alternative option of patenting 'medicines' instead.
• TRIPS allows -but does not require- exempting plants and animals from patentability;
• TRIPS requires that countries provide protection for plant varieties, but specifies that they are free to do this via the patent system or via an effective sui generis system.
Further, it is worth noting that TRIPS requires:
• protection of undisclosed information or trade secrets against unfair competition and against dishonest practices, without however requiring that exclusive rights be granted to the holder of a trade secret;
• measures against unfair competition and misleading practices with regard to indications on the geographical origin of products.
However, when looking at conventional IPR -or TRIPS- for the protection of traditional medicine, the most important feature seems to be the lacunae - notably the absence of mechanisms for dealing with collectively held intellectual property. Thus, with regard to traditional medicine, the impression is one of a mismatch between TRIPS provisions and countries' needs (see chapter 4).