(2000; 91 pages)
Most ASEAN Countries are either members or observers of the World Trade Organization (WTO); this means they are committed to follow the rules laid down in its Agreements, or intend to make these commitments in future. One of these WTO Agreements is the Agreement on Trade Related aspects of Intellectual Property Rights (TRIPs). The TRIPs Agreement makes the granting of patents for pharmaceuticals obligatory. Since previously many developing countries allowed only for limited patent protection in this area, this represents a significant change in the pharmaceutical sector. Proponents believe this will lead to an increase in investment and in R&D, yet numerous public health experts, as well as consumer groups, have expressed concern about the impact of the TRIPS Agreement on the availability and prices of drugs. Moreover, worldwide, there is growing concern about the impact of the intellectual property rights system on innovation and on investment. A global process of rethinking is starting, in which developing countries should actively participate.
The TRIPS Agreement is not a uniform law, but a framework that sets (minimum) standards and conditions for the protection of intellectual property. These are made operational via the national intellectual property rights (IPR) legislation. Within the TRIPs framework, there is some room for manoeuvre, which can be used to design legislation which is in the best interest of the country. Measures to protect the public interest ought to be included in the national legislation, and should encompass public health aspects. In fact, TRIPS provides for a number of safeguards which may be used to protect public health and promote competition, such as compulsory licensing, and allows for exceptions which may facilitate the marketing of generic drugs (“Bolar exception”). These safeguards can be used to mitigate potential negative impacts of increased IPR protection in the pharmaceutical sector on access to drugs. However, these safeguards can only be used if they have been incorporated in the national legislation.
Safeguards such as provisions for compulsory licensing are an essential element of IPR legislation, since they signal to the patent holder that, in the case of abuse of rights and/or non-availability of the product, a third party could be allowed to use the invention. As such, they reduce the risk of misuse of the monopoly rights conferred by a patent. However, to ensure that such safeguards can be used effectively, it is important to carefully state the grounds and conditions for their use in the national legislation.
TRIPS requires that patents are granted when the typical standards for patentability, that is, novelty, inventive step and industrial applicability, are met. But the Agreement does not specify how these criteria should be defined; WTO member countries may decide how to apply these criteria. In the pharmaceutical sector, applying these criteria in a flexible way will facilitate the granting of ‘secondary’ patents, such as formulation patents, patents on polymorphs etc. Even if such secondary patents are relatively weak, they can be used aggressively to (threaten to) litigate, in order to stop competition. Therefore, defining the scope of patentability at the national level is an important issue.
Similarly, enforcement rules can have significant implications, since, once a patent has been granted, there is a presumption of validity. If countries have strong provisional measures under their enforcement system, these can be used to prevent competition for instance while a lawsuit is pending (which can be several years). In the absence of competition, monopolistic pricing may reduce people’s access. However, if eventually a patent is found to be invalid or an enforcement rule to be unjustified, from a societal point of view it is important to consider who will reimburse the consumers, and how many people have in the meantime been denied access to essential medicines.
Outline of the report
This report aims to give an overview of the TRIPS Agreement and its possible implications on the pharmaceutical sector in developing countries; what are the issues and what are the options?
It only sketches the broad picture - in order to address these issues at national level and to draft legislation that balances the interests of producers and users of technology, cooperation among the Ministry of Health, the Ministry of Trade and the Intellectual Property Rights Office will be of utmost importance.
The first - and main - part of this report has been compiled on the basis of input from the resource persons at the workshop. It starts, in section I, with a short introduction. Thereafter, section II “general issues” provides briefly some essential background information on WTO and IPR; moreover a substantial portion is based on input from major stakeholders, since policy makers will encounter their important, differing and firm views - and will have to take them into consideration;
Section III deals with technical issues and how they translate into social and public health realities; and section IV “special issues” provides some initial reflections on how several of these concepts translate into the specific areas of traditional medicine(s) and biotechnology.
The second - smaller - part of the report lists some of the issues discussed, and contains the recommendations.