- Keywords > compulsory licences
- Keywords > globalization
- Keywords > innovation and intellectual property
- Keywords > Intellectual Property Rights (IPR)
- Keywords > patent system
- Keywords > patentability criteria - policy options
- Keywords > trade and innovation
- Keywords > Trade Related Aspects of the Intellectual Property Rights (TRIPS)
- Keywords > TRIPS flexibilities
- Keywords > Uruguay Round
(1998; 97 pages) [French] [Spanish]
3.2 Some recommendations
Each country’s strategy in regard to globalization in the field of the production and distribution of drugs will have to be incorporated into its national pharmaceutical policy, a component of national health policy.
The new international economic and social context is likely to have an important effect on the equitable access of populations to health and to drugs, especially in developing countries. The new rules in the area of intellectual property could increase these countries’ dependence still further.
The major implications concerning access to drugs are linked with the strengthening of the monopoly of working conferred by a patent on its holder. By 2005 at the latest, all developing countries will have to grant legal protection by patents to pharmaceutical products. Such a monopoly situation could lead to an increase in drug prices. That is why developing countries that are WTO Members should make the fullest use of the periods of transition they have been granted to transcribe the provisions of the TRIPS Agreement into their domestic law. Member States have an obligation to integrate into their patent legislation the minimal standards established by the TRIPS Agreement (patents for 20 years, no differential treatment between nationals and foreigners, reversal of the burden of proof), but the Agreement leaves certain margins of freedom that can be used to limit the adverse effects on prices and access to technology.
Thus, under the exceptions to the monopoly that are authorized by the Agreement, the law should cover the possibility of authorizing parallel importation of patented drugs sold at lower prices in another country, or establish - as has been done by the Group of Andean Countries - that a drug on the WHO Model List of Essential Drugs should be the object of a compulsory licence for public health reasons, under the conditions laid down in the TRIPS Agreement.
At the same time, a certain number of “sensitive” provisions of the TRIPS Agreement, particularly the general principles concerning the protection of health, the obligation to exploit the patent locally, anti-competitive practices, and the exclusive marketing rights conferred during the periods of transition, will necessarily be subject to interpretation in their application. It would seem fundamental for developing countries to establish a joint position vis-à-vis these hotly debated questions, a position founded on the demand for a balance of rights, and also of the duties of patent holders vis-à-vis the community.
Finally, the new provisions of the TRIPS Agreement may have, to a greater or lesser extent, serious implications for the pharmaceutical sector, even if it is impossible to quantify them at present. It is essential that everyone involved in this sector should understand what is at stake and play an active part in the reforms of intellectual property regulations that are under way. National drugs policies should define strategies and guidelines today for the new regulations on patents, the new conditions for the transfer of technology, the new orientation of R&D, etc. All of these elements could have an important impact on access to drugs, one of the main objectives of national pharmaceutical policy recommended by WHO.