Minutes - TRIPS Council - View details of the intervention/statement

Ambassador Mothusi Palai (Botswana)
171. As Canada has previously said, while the Paragraph 6 System is a useful tool, it should not be regarded as a panacea for the complex problem of access to medicines. Indeed, medicines are one of the many components of health systems, the price of medicines is one of the many factors affecting access to those medicines, and intellectual property is one of the numerous factors influencing the price of medicines. The impact of intellectual property rights on access to medicines, on the price of those medicines and on health care in general is proportionate to the role played by intellectual property in relation to other factors affecting the price and availability of medicines, including infrastructure, health systems, regulations, distribution and administration of medicines, in addition to customs tariffs and other taxes applicable to them. 172. Indeed, it is our understanding that a quarter of Members eligible for the Paragraph 6 System without notification under paragraph 1(b) of the Decision of 30 August 2003 continue to impose import tariffs on medicines at rates of up to 15%, or even 25%. The situation is comparable for other eligible Members. Moreover, a 2011 study by the WHO and the Dutch NGO Health Action International shows that many Members that are eligible for the Paragraph 6 System apply different taxes on medicines in addition to port, customs clearance, transport and/or inspection charges, at rates ranging from 5 to 34%, on top of customs tariffs where they exist. Another study by the same two organizations, published in 2014, reveals that increased distribution charges can push up the price of medicines by another 17 to 84% in relation to the manufacturer's price in low- and middle-income countries, regardless of the patent status. 173. In other words, we think that tariffs, taxes and charges on medicines can neutralize, at least in part, the beneficial effects of the flexibilities we have given ourselves, which is tantamount to lifting a barrier to exportation and availability on the one hand while erecting barriers to access to medicines on the other. 174. This being the case, we cannot examine either the Paragraph 6 System or intellectual property in isolation from the other issues affecting access to medicines. Canada would like to note that according to a United Nations report published in 2014, even essential generic medicines are available in only 55% of public sector health facilities in low- and middle income countries. In other words, the absence of a patent on a particular medicine is no guarantee of its availability; hence the need to examine all of the factors that impact access to medicines, as well as all of the supply mechanisms. In this connection, Canada would like to underscore the importance of voluntary licences, including those obtained through the Medicines Patent Pool, as well as pooled supply systems such as those used by the East African Community. We would be happy to discuss the experiences of importing Members eligible for the Paragraph 6 System in this respect, and more generally, the supply mechanisms they advocate and the challenges those mechanisms would involve. 175. We reiterate that Canada's Access to Medicines Regime that implements the Paragraph 6 System, clearly functions well in its current form, and meets the requirements and parameters laid down in the Doha Declaration on the TRIPS Agreement and Public Health. The Canadian Access to Medicines Regime is just one of many aspects of Canada's firm commitment and leadership when it comes to access to medicines and public health for the least developed and developing countries. 176. Let me conclude by calling upon all Members that have not already done so to deposit their instruments of acceptance of the Protocol Amending the TRIPS Agreement.
The Council took note of statements made and agreed on the draft cover note to the report. It also agreed that the record of the discussion be attached to it.
6.1. The Chairman recalled that the standard format for the review had been that, after an introduction and update on recent developments by the Chairman, the floor was opened to delegates for comments. In 2010 and 2011, the Council had held more structured debates. They had been conducted on the basis of a list of topics for the discussion that had been agreed in advance of the reviews. In light of the feedback previous Chairmen had received in their consultations prior to the subsequent reviews, the 2012 and 2013 reviews had again followed the standard format.

6.2. At his informal consultations in June 2014, he had encouraged delegations to consider how the Council should conduct the present review. In light of the feedback received, the Chairman suggested that the standard format be followed this year. The records of earlier reviews, including the exchange of questions and responses, continued to provide a unique and valuable resource for understanding this important measure and might inform Members' discussions at this review. If Members felt that any questions regarding the Paragraph 6 System itself or possible alternatives to it had not been adequately addressed at past reviews, they should feel free to revert to any such questions.

6.3. As regards the purpose of the review, he recalled that paragraph 8 of the waiver Decision provided that the Council for TRIPS shall review annually the functioning of the system set out in the Decision with a view to ensuring its effective operation and shall annually report on its operation to the General Council. Furthermore, the paragraph provided that this review shall be deemed to fulfil the review requirements of Article IX:4 of the WTO Agreement.

6.4. The Secretariat had prepared a draft cover note for the Council's report modelled on previous years' reports (circulated as JOB/IP/11). He suggested that the Council take up the preparation of its report to the General Council after it had exhausted its discussion. Paragraph 8 of the cover note contained a list of Members that had notified their acceptance of the Protocol. The following Members had deposited their instruments of acceptance since the Council's last meeting in June: Botswana on 18 June and Uruguay on 31 July.

6.5. He recalled that the Protocol had originally been open for acceptance by Members until 1 December 2007. Upon proposals by the TRIPS Council, the General Council had four times extended this period for further two-year periods. At present, the period extended until 31 December 2015. 53 instruments of acceptance, including from the European Union, had been deposited with the WTO Director-General. In order for the TRIPS amendment to enter into force, acceptance by two thirds of the membership was, however, required. He therefore strongly encouraged Members who had not yet completed their domestic procedures to do so as soon as possible.

6.6. He said that, regarding how accepting the Protocol related to the implementation of the Paragraph 6 System in a Member's domestic legal framework, these were two entirely separate acts; the Protocol could therefore be accepted independently from adopting domestic implementing legislation. By accepting the Protocol, a Member expressed its consent that other WTO Members were entitled to use the additional flexibility that the System provided. Should a WTO Member wish to take advantage itself of these additional flexibilities, it might need to domestically implement appropriate legislative measures. But since these two processes were entirely separate, a Member might choose to deposit an instrument of acceptance of the Protocol without the need to wait for any domestic implementation. Many instruments of acceptance that the WTO had received had been deposited before the Member in question had adopted any domestic implementing legislation.

6.7. The representatives of Chile; Uganda on behalf of the LDC Group; India; Brazil; Cuba; China; Chinese Taipei; the United States; Australia; Canada; Japan; the European Union; Switzerland; Egypt and the Secretariats of WTO; WIPO and WHO took the floor.

6.8. Referring to the draft cover note for the Council's report to the General Council (circulated as JOB/IP/11), the Chairman said that it contained factual information on the implementation and use of the system established under the Decision, as well as on the status of acceptances of the Protocol Amending the TRIPS Agreement. In accordance with the way that the Council had prepared its reports in the previous years, the part of the minutes of the meeting that would reflect the discussions held under this agenda item might be attached to the cover note.

6.9. The Council took note of statements made and agreed on the draft cover note to the report. It also agreed that the record of the discussion be attached to it.

IP/C/M/77, IP/C/M/77/Add.1