Actas - Consejo de los ADPIC - Ver detalles de la intervención/declaración

Ambassador Karen Tan (Singapore)
N.ii Operation of the Paragraph 6 System
168. The Chairperson recalled that paragraph 8 of the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and the Public Health provided that the Council for TRIPS should review annually the functioning of the System set out in the Decision with a view to ensuring its effective operation and should annually report on its operation to the General Council. The TRIPS Council held its sixth review of the Paragraph 6 System at its meeting in October 2009. The seventh review was scheduled to take place in October 2010. 169. At the Council's review in October 2009, the Council had requested her to hold a round of informal consultations on the operation of the System before this formal meeting for the purpose of providing a platform to share experiences and look at concerns in an informal setting, without prejudicing the outcome. In response to that request, she had held an informal meeting on 12 February 2010. 170. She said that she had found the informal meeting to be very constructive. Her impression had been that Members were interested in sharing experiences on the use of the System and were ready to engage in practical fact-based discussions in order to have a full understanding of the operation of the System. 171. As regards the specific points made by delegations, she said that some delegations had been concerned that the System had been used only once by Rwanda and Canada which, in their view, raised the question of whether the System had met its objective of providing an expeditious solution to problems faced by countries with insufficient or no manufacturing capacities in the pharmaceutical sector. It had also been said that the fact that the System had only been used once did not imply that it was inadequate, since there were also other ways to get medicines to patients. Some delegations had argued that the number of licences issued under the System was not the proper measure of its success, and that the use of the System by Rwanda and Canada had demonstrated that the System could work effectively. They considered that the System could only play a supportive role in the wider effort to improve access to essential medicines, and that its mere existence could have had a positive impact on drug prices. 172. Concerns had also been expressed about the period of some three years that it had taken to deliver the medicines to Rwanda in this particular case. In this respect, Canada had shared experience on its use of the System, giving a detailed account of the timeline of the shipments under the System, attributing the bulk of the time consumed not to the specific requirements of the Paragraph 6 System, but to factors such as identifying a recipient country for the available medicine, and the government procurement process in the recipient country which required a competitive tendering process. 173. As regards the topics that might warrant more discussion, it had been suggested that the focus could be on the experience from the use of the System by Rwanda and Canada to consider whether the System was working effectively. Some delegations had said that the performance of the System could be appraised more generally to assess whether there were any procedural problems regarding its operation. Some Members had said that, bearing in mind that the System was demand-driven, it would be helpful to know whether there were some concrete obstacles preventing potential importers from procuring under it. Among other issues mentioned that might merit further discussion were safety and efficacy of medicines procured under the System, government procurement, and the dissemination of information with a view to building capacity in developing countries to use the System. 174. She said that Members had also discussed the appropriate ways to address the aforementioned issues, agreeing that annual reviews were a good platform for sharing experiences and evaluating the operation of the System. However, some delegations had suggested that this work be complemented by organizing a dedicated workshop open to all stake-holders. Some other delegations had said that the review process was a Member-driven exercise, but believed that its usefulness could be enhanced, inter alia, by more factual input. 175. Finally, there had been calls for the Chair to consult with interested delegations on how to best address the issues raised in this discussion. A number of delegations had expressed their willingness to participate in any consultations that the Chair might decide to hold on the matter.