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

Ms Irene Young (Hong Kong, China)
76. India welcomes the entry into force of the Protocol Amending the TRIPS Agreement in January this year, which is the first amendment to a multilateral treaty since the WTO Agreement came into force in 1995. India attaches high importance to the Doha Declaration on TRIPS and Public Health, the Paragraph 6 System as established under the 2003 Waiver Decision, and the Protocol Amending the TRIPS Agreement. India was one of the first countries that notified its acceptance of the Protocol in March 2007, and we would like to congratulate Members who have deposited their instrument of acceptance after the special meeting of the TRIPS Council in January. India has always been of the view that the Doha Declaration on TRIPS and Public Health constituted a major landmark in the history of the WTO because it recognized the primacy of public health needs and the preparedness of organizations to address the problem of access to medicines faced by the poor in developing countries. The 2003 Waiver Decision was expected to address public health problems faced by Members with insufficient or no manufacturing capacities in the pharmaceutical sector. It may have sounded prophetic at that time, when India voiced certain apprehensions in the General Council meeting of August 2003, and I quote "the results accruing from this mechanism should not be negated by the creation of cumbersome systems that would lead to huge delays in getting medicines across at reasonable cost to those that needed them or discourage Members from using the System for the benefit of the people. In order to make the System successful, a sincere collective effort was required on the part of all Members and the entire pharmaceutical industry." 77. Regrettably, we have been proven right. The export of HIV/AIDS medicines by the Canadian pharmaceutical company Apotex to Rwanda in September 2008 has been the first and only use of the System so far. The Trilateral Study by WTO, WHO and WIPO on Promoting Access to Medicines and Medical Technologies and Innovation: Intersection between Public Health, Intellectual Property and Trade of 2013 highlights some of the issues that need to be addressed for any meaningful utilisation of the System. We need to consider those issues carefully so that this measure does not remain confined only to paper. 78. The UN Secretary-General High Level Panel on Access to Medicines, in its report released in September 2016, also recognised that the Paragraph 6 System is complex and cumbersome. It recommended that WTO Members revise the System in order to find a solution that enables a swift and expeditious export of pharmaceutical products produced under compulsory licence. WTO Members should, as necessary, adopt a waiver and permanent revision of the TRIPS Agreement to enable this reform. During an event held on the side lines of the TRIPS Council meeting in November 2016, several participants also highlighted that the System was not workable in its current form, and that it was too complex, cumbersome and administratively unwieldly for use, and that it was commercially non-viable for companies to supply medicines under it. We urge Members to constructively engage on the question of improving the Paragraph 6 System for making it more workable and more effective so that it can benefit Members with insufficient or no manufacturing capacity in the pharmaceutical sector. 79. To come to a specific question, some Members who notify their acceptance have not incorporated the System into national law. We encourage these Members to take the necessary steps to incorporate the System into their national laws. We also encourage Members who are yet to notify their acceptance of the 2005 Protocol to do so by the end of the year. However, I am informed that as many as 46 Members are yet to accept the Protocol, and it may not be possible for all of them to notify their acceptance in time. We therefore support the extension of the deadline for accepting the Protocol by a further period of two years.
The Council so agreed.
20. The Chairperson said that paragraph 7 of the Annex to the amended TRIPS Agreement and paragraph 8 of the 2003 Waiver Decision required the Council to review the functioning of the special compulsory licensing system (the "System") annually, with a view to ensuring its effective operation. The Council was also required to report annually on the System's operation to the General Council. In the case of the Waiver Decision, the review was also deemed to have fulfilled the requirements of Article IX:4 of the WTO Agreement.

21. She invited Members to exchange views on the functioning of the System. Two documents could serve as background for the discussion: (i) the TRIPS Council's report on its annual review in 2016 (IP/C/76); and (ii) the Secretariat's 2016 report on its technical cooperation in the TRIPS area (IP/C/W/618). Annex II of the latter document summarized the discussions on the practical use of the Paragraph 6 System.

22. Turning to the Council's report to the General Council, the Chairperson noted that a draft cover note, modelled on previous reports, had been prepared by the Secretariat (JOB/IP/27). It contained factual information on the implementation and use of the System. The draft would need to be updated to reflect the recent acceptance of the Protocol by the Russian Federation. The minutes of the discussion under this agenda would also have to be attached as Annex 1 and Appendix 1.

23. Additionally, the Council would need to decide on Annex 2, which referred to the Protocol Amending the TRIPS Agreement. She recalled that the Protocol was currently open for acceptance by Members until 31 December 2017. There were 46 Members that had not yet accepted the Protocol. As it was unlikely that all of them would do so before the end of 2017, the Council needed to consider the way forward. Previous consultations had indicated that most Members would like to see a further extension of the period for acceptance. A draft decision to that effect, for adoption by the General Council, had been included as Annex 2 to the draft report. The draft decision did not yet contain a deadline. At a recent informal meeting of the TRIPS Council, one delegation had raised the possibility of an indefinite extension. However, most delegations had preferred a fixed deadline, either a two year or a four year extension. She suggested focusing the discussion on these two options and that the Council decide on the one with greater support.

24. The representatives of India; the United States; Barbados; the European Union; Haiti on behalf of the LDC Group; Brazil; Canada; South Africa; Switzerland; Japan; Thailand; the Republic of Korea; the Russian Federation; Australia; China; Costa Rica; and Nigeria on behalf of the African Group took the floor.

25. The Council took note of the statements made.

26. The Chairperson proposed that the Council agree on forwarding to the General Council the proposal for a decision to extend the period for acceptance by Members of the Protocol Amending the TRIPS Agreement until 31 December 2019. The last paragraph of the draft decision by the General Council contained in Annex 2 to the draft report should be complemented by inserting this date. She also proposed that the Council agree on the cover note to the report contained in JOB/IP/27, with updates concerning an instrument of acceptance that had been deposited since the circulation of the draft cover note, and also that the Council minutes containing the record of the discussion be attached to it as Annex 1 and Appendix 1.

27. The Council so agreed.

IP/C/M/87, IP/C/M/87/Add.1