Dr Germán Velásquez, Coordinator of the Drug Action Programme, WHO Geneva, presented a paper on this topic.
The Uruguay Round led to the creation of the World Trade Organization (WTO), which became operational in January 1995. The WTO is the international organization dealing with rules of trade between nations. WTO administers global trade agreements that were negotiated and approved during the Uruguay Round, and are binding on all Members.
Among these agreements, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) links intellectual property and trade issues for the first time and relates it to a multilateral mechanism for settling disputes between WTO Members on intellectual property. This agreement is the most comprehensive international agreement ever reached on intellectual property. It establishes minimum universal standards for almost all rights in this field (such as copyrights, patents and trademarks), including patent protection for pharmaceutical products, which may have a significant impact on access to drugs in developing countries.
Under the TRIPS Agreement, all WTO Members (139 in November 2000) have to make patent protection available for at least 20 years for any invention of pharmaceutical products or process which fulfils the criteria of novelty, inventiveness and usefulness.
Prior to the TRIPS Agreement, many countries did not make patent protection available for pharmaceuticals, in order to permit the manufacture of copies and generic equivalents of drugs at reduced prices.
Some characteristics of the TRIPS Agreement:
• Minimum standards for intellectual property.
• Obligatory for all members of WTO.
• New: patents for products and processes.
• Patents for a minimum period of 20 years.
• A certain amount of freedom for Members.
• The terms “invention” and “discovery” are not defined in the Agreement.
The TRIPS Agreement obliges Members to treat inventions in the pharmaceutical field like inventions in any other field of technology. But essential drugs are NOT simple commodities and access to essential drugs is a human right. Patent protection has been an incentive for research and development for new drugs although it does not follow that these have been affordable to all people. Patents should be managed in an impartial way protecting the interest of the patent holder as well as safeguarding public health principles. The patent system in the private sector should not be seen as the only source of finance for pharmaceutical research.
WHO also encourages other sources, such as the public sector, to finance research and development in pharmaceuticals.
Each country’s strategy towards globalization in the field of the production and distribution of drugs should be incorporated into a national pharmaceutical policy within the national health policy. In this context WHO supports measures which will improve access to all essential drugs, including mechanisms to promote competition, such as: price information, generics policies, reduced duties, taxes, mark ups, equity pricing of newer essential drugs and the application of WTO/TRIPS safeguards, as needed. These safeguards include compulsory licensing, exceptions which can promote generic competition (e.g. Bolar provision) and extension of the transitional period.
WHO recognizes that the TRIPS Agreement does not prohibit parallel imports. “TRIPS-plus” is a non-technical term which refers to efforts to: extend patent life beyond the 20-year TRIPS minimum; limit compulsory licensing in ways not required by TRIPS; and limit exceptions which facilitate prompt introduction of generics.
Since the public health impact of the basic TRIPS requirements have yet to be fully assessed, WHO recommends that developing countries be cautious about enacting legislation that is more stringent than the TRIPS requirements.. Finally, WHO also recognizes that over 50 of its Members States are either not WTO members or have an observer status at WTO. These Members States are not constrained by any requirement of TRIPS. Countries acceding to the WTO are encouraged to integrate public health concerns into their national patent legislation.