187. I would like to add the thanks from my delegation to my neighbour who has just intervened and to the Director-General and to yourself and the WTO Secretariat for all your efforts to secure the necessary number of acceptances of the Protocol during this year. We certainly commend those 15 WTO Members who have completed their acceptance procedure so far this year.
188. We also thank the WTO Secretariat for holding its 12th Workshop on Trade and Public Health, as noted in its annual report in document IP/C/W/618, as a capacity-building Workshop to raise awareness about the System and to help Members make effective use of it.
189. Switzerland was among the first WTO Members to put in place the necessary legislation to enable the System at the national level and use of the mechanism for export. According to information available from the WTO Secretariat, more than 52 WTO Members have done so by today covering about 80% of current medicines export capacity. This was done on the basis of the waiver solutions agreed in 2003, and in spite of the fact that the TRIPS Amendment has not yet entered into force. This demonstrates the commitment and the support of WTO Members for the use of the Paragraph 6 System. In the Paragraph 6 Review in the TRIPS Council, Members have confirmed this political support and encouragement for use of the System.
190. I would like to refer to two points that have been mentioned by preceding speakers. One was the complexity and cumbersomeness of the System that was claimed. However, in our recollection, in past reviews in this Council of the Paragraph 6 System, we have not heard, at least not from potential beneficiary Members, of cases where the System needed to be used, but was not used or dropped because it was too complex, or that the process of making it proved to be not workable at any specific stage of the System.
191. When we look at the System it seems quite straightforward. The WTO Secretariat is assisting Members who may want to use the Paragraph 6 System very helpfully through all the information and the special dedicated website on the WTO site. Notifications certainly should not pose a problem.
192. Concerns were raised with regard to the need of having to mark medicines that are produced under special compulsory licence. Switzerland has argued in earlier reviews that such special marking of medicines is in the very interest of the potential beneficiary country because it will ensure that the medicines produced under such a special licence reach the people who need these medicines.
193. Also, the requirement for the generic producer under such a licence to put up a website has been described as cumbersome. However, I believe hosting a website for a generic manufacture capable of actually assisting under this System should not pose an unsurmountable hurdle nowadays.
194. Having said this, compulsory licences are as such not an easy and quick-fix solution to address the broader problem of sustainable access to affordable medicines – whether in developing countries or any other WTO Member. Implementing a compulsory licence, and again I refer to normal or special compulsory licences even once granted, pose their own challenges. A generic manufacturer needs to be found who is ready, willing and available to produce the medicine needed and the quantities needed within a short time-period at an affordable and competitive price and at the required quality and safety standards. This demonstrates that a compulsory licence is never a quick-fix solution and this cannot be remedied by the Paragraph 6 System or by revising it for that matter.
195. Also, the fact that the System has only been used once so far was taken as evidence that the System is not workable. However, I believe it is important to note, as stated by the EU, that the Paragraph 6 System does not have result in the grant of an export licence. One of its key benefits is to give all WTO Members, including those without manufacturing capacity in the pharmaceutical market, the negotiation leverage when they need to address a specific public health problem and to negotiate with potential manufacturers the price and any delivery conditions for receiving the needed medicine. That was the very basis of the mandate that Ministers gave the TRIPS Council in the Doha Declaration on the TRIPS Agreement and Public Health. Their intention was to ensure that this policy flexibility that was identified and confirmed in the Doha Declaration would be available to all WTO Members equally.
196. The case of Canada-Rwanda was the first one and was not an easy one. Always when you do a thing for the first time, you learn lessons. Therefore, we do believe that the Paragraph 6 Review, within this Council, is extremely beneficial for Members to exchange and share experiences made, raise concerns so that all can learn for any next use of the Paragraph 6 System.
197. We have also heard that in many cases the Paragraph 6 System might not have been needed since medicine was available from a country or manufacturer in a country where this medicine was still available off patent. It has also been mentioned in that context that in the future this might be less often the case. In my delegation's view, this only raises the importance of the Paragraph 6 System in the future. Therefore, we very much welcome the discussions in this Council under the Paragraph 6 Review so that we can learn how to make this System and its application in practice more useful to potential beneficiary countries.
