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Symposium on issues confronting the world trading system
summary reports by the moderators

6 and 7 July, World Trade Organization, Geneva, Switzerland  

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Friday, 6 July

Session II: TRIPS — Access to essential medicines

Moderator: Adrian Otten — Director, WTO Intellectual Property Division

This work session was characterized by a lively and, I believe, useful exchange of views, thanks to the active participation of a wide range of participants, including those from health and developmental non-governmental organizations, industry and professional associations, and academics.

I think it fair to say that the general starting point was that, from a public health perspective, patents are important in providing incentives for the generation of new drugs, but that a balance has to be found with the need to ensure access to existing drugs, especially in the poorest countries. There was some discussion about the extent to which this balance has been taken into account in the negotiation of the TRIPS Agreement and in its provisions and also about the extent to which the provisions of human rights conventions regarding health are taken into account. It was noted that the objectives of the TRIPS Agreement, as set out in its Article 7, specifically recognize the need for balance between the promotion of new inventions and access to existing ones and that Article 8.1 of the TRIPS Agreement makes specific reference to the protection of public health and nutrition. As I will indicate later, much of the discussion revolved around the extent to which the flexibility in the TRIPS Agreement enables countries to find a proper balance that takes into account their public health needs.

The point was made that, in finding this balance, it is important to assess the extent to which the patent system is delivering on its objective of promoting research and development into new drugs and whether there are other possible alternatives. In this connection, different views were expressed on a range of points, including the size of the research and development effort by the private sector, the extent to which this is directed towards genuinely needed therapeutic advances, in particular in regard to the diseases more prevalent amongst poor people in developing countries, the relative roles of the public and private contribution towards research and development into new drugs, and whether the patent system, at least in some countries, sets the test of the inventiveness sufficiently high. While I believe it was generally accepted that the patent system is important for private sector research and development, it was recognized that, where the market for new drugs is weak, even under patent protection, it may need to be complemented with other measures, notably in order to ensure sufficient research and development into the neglected diseases of the poor.

The point was also made that the patent system plays an important role in encouraging disclosure, and thus the dissemination, of inventions which companies might otherwise be tempted to keep secret.

Turning to the other side of the coin, namely the effect of the patent system on access to existing drugs, there was a fair amount of debate about the extent to which the patent system poses a problem and how significant this is relative to other factors affecting access to drugs. Different views were expressed on a number of issues in this connection, including the extent to which patents affect prices, the significance of patented drugs now and in the future among drugs essential for basic health care, and the relative role of prices compared to other factors affecting access, such as health care supply systems and funding. Some participants believed that it is important to assess the impact of the patent system on a case-by-case and country-by-country basis. There was discussion about the extent to which countries in which drugs are not patent protected experience the same problems of access to drugs as other countries.

With regard to the flexibility in the TRIPS Agreement, the discussion revolved around two main points. One was the extent to which countries feel confident and secure in using this flexibility and the other was the scope of the flexibility.

On the former point, concern was expressed that countries, especially those who have less bargaining power in international economic relations, have felt and might still feel constrained in using the full flexibility under the TRIPS Agreement to promote their public health objectives, due, on the one hand, to uncertainty about the scope of this flexibility and, on the other hand, to bilateral or other pressures not to use it. References were made to a number of recent legal cases and also to negotiations relating to regional and bilateral trade arrangements. There was discussion about how these concerns could be met, especially if the avenue of providing greater legal certainty through court and dispute settlement interpretation is not to be followed. In this regard, the work session was informed of the ongoing work in the Council for TRIPS aimed at clarifying the flexibility available in the TRIPS Agreement.

With regard to the scope of the flexibility in the TRIPS Agreement, the main provisions that were discussed were those relating to compulsory licensing, parallel imports, the so-called Bolar or regulatory exception under which generic companies can use patented inventions for the purposes of obtaining regulatory authorization for the prompt marketing of their generic versions after the expiry of the patent term, and other possible exceptions covered by Article 30 of the TRIPS Agreement. One general issue that was raised in connection with the scope of the flexibility was whether it is sufficient to enable countries at different stages of development to establish the optimal balance in their intellectual property system from a public health perspective. Reference was made to the possibility for extensions to the transition periods of least-developed countries.

Time did not permit for a detailed exchange of views on the relevant provisions of the TRIPS Agreement, although a number of different views were expressed regarding compulsory licensing and parallel imports. On the former point, compulsory licensing, one general issue that was discussed went to the question of differing underlying conceptions of what is required for the patent system to work effectively in promoting research and development. One view was that the system is designed to provide incentives for future research and development, not merely to enable recovery of research and development costs already incurred, and that if this objective is to be met, the patent right had to be viewed as essentially an exclusive right, with compulsory licensing used as a remedy only in cases of misuse of that exclusive right. For some other participants, the patent system could continue to serve its underlying purpose even with a more widespread and systematic use of compulsory licensing where warranted by public health objectives. Among the more specific points that were touched upon in relation to the TRIPS provisions on compulsory licensing were the relation between the TRIPS rule relating to non-discrimination between areas of technology and the scope for giving compulsory licences on public health grounds, how to ensure that countries with small markets who give compulsory licences for importation are able to obtain the necessary supply, and the way in which the TRIPS Agreement affects the use of compulsory licensing to promote local domestic production, the so-called local working requirement.

A couple of other points which came up which I should also mention were, first, the impact of the TRIPS rules relating to the protection of test and other data submitted to drug regulatory authorities in order to obtain marketing approval for new drugs and, secondly, the question of the protection of traditional knowledge in medicines. This latter point is, of course, highly relevant to the second TRIPS work session on which you will be receiving a separate report.

This then is my report on the work session on TRIPS and Access to Essential Medicines. I should emphasize that it is submitted on my personal responsibility and represents my own attempt to highlight the main points of discussion. It is a summary and thus by its very nature not exhaustive of all the points made in what I believe was a rich, useful and constructive exchange of views.


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