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

Ms Irene Young (Hong Kong, China)
92. Switzerland welcomed the entry into force of the revised TRIPS Agreement, incorporating the Paragraph 6 solution. While the Paragraph 6 mechanism could already be used since 2003 through the waiver decision, inserting the new Article 31bis into the TRIPS Agreement clearly adds transparency, clarity and legal certainty. It is also a positive signal illustrating that the WTO and its Members are willing and able to recognise relevant public policy challenges and find appropriate solutions to them. Switzerland ratified the amendment back in 2006 as the second WTO Member. We implemented the special compulsory licensing system in our national legislation in 2008. 93. Article 31bis of the TRIPS Agreement addresses the particular situation of developing countries with insufficient or no manufacturing capacity in the pharmaceutical sector. It removes a potential legal barrier for countries without a relevant pharmaceutical manufacturing industry to use the instrument of a compulsory license that may have occurred otherwise under Article 31(f) of the TRIPS Agreement. The new System was used when Rwanda imported medicines under the Paragraph 6 mechanism from Apotex in Canada. 94. The Paragraph 6 solution has been criticised earlier by some delegations and certain civil society actors as being complex and burdensome. My delegation disagrees with this view. We have not heard in the Council's past Paragraph 6 reviews from potential beneficiary Members about hurdles that they would have faced when wishing to make use of the mechanism. The WTO Secretariat has provided on its website an illustrative guide on how to use the Paragraph 6 mechanism efficiently, and we believe it demonstrates how straightforward this use can be. 95. Claims that the System is not working simply because it has been used only once so far are jumping to conclusions. A more likely explanation is that other modalities, instruments or mechanisms are just as, if not more relevant and efficient to facilitate access to pharmaceutical products, and are being made use of more regularly. In our view, it is wrong to consider the Paragraph 6 solution and the new Article 31bis as a silver bullet to the access to medicines issue. We should avoid raising overstated expectations of what the TRIPS Agreement can contribute. 96. Article 31bis is a special compulsory license. Compulsory licenses are a flexibility foreseen in the TRIPS Agreement. They may be used, provided a number of circumstances are present and conditions are fulfilled. However, my delegation considers compulsory licences, whether under Article 31 or Article 31bis of the TRIPS Agreement, neither an efficient nor a simple tool to use to gain quick access to essential medicines. Compulsory licensing may overcome a patent-related barrier. However, most of the time, other barriers are present, as well. Lack of infrastructure, of diagnostics and health care personnel, insufficient provider or patient knowledge may come into play and prevent access. Insufficient or inexistent public health care, mark-ups by intermediaries or customs duties imposed by governments also impact on affordability. 97. Pharmaceutical companies, whether R&D originators or generic manufacturers, need financial incentives to invest in the manufacturing of relevant medical products, i.e. a fair return on their investment. Even the production of medical products under a compulsory license costs money and so does getting the relevant marketing authorisation by regulatory agencies. 98. Many countries face challenges related to access to medical products. It is important to address these challenges in a holistic and sustainable manner. Switzerland has been a long-time supporter of strengthening health systems and sustainable financing, including through domestic resources. Our Government sees this as one of the primary avenues to facilitate access to medical products. 99. Instead of advocating the use of compulsory licenses, which are by nature contentious in their approach, this delegation strongly believes in the promotion of initiatives and approaches that incentivise research and development, add transparency, bring potential partners together to make use of synergies and, by the same token, improve access to affordable medical products for people in low- and middle-income countries. 100. We believe that building on voluntary and inclusive efforts, such as the Medicines Patent Pool, the Global Fund's e-procurement platform, WIPO Re:SEARCH, product development partnerships, such as DNDi, or the recent patent information transparency partnership Pat INFORMED launched by WIPO and the private sector, are the way forward and correspond to the collaborative spirit of the 2030 Agenda for Sustainable Development. 101. Switzerland has no comments on the draft report apart from expressing our gratitude to the Secretariat for preparing it. 102. As concerns the further extension of the period of acceptance, my delegation has, as others, a preference for a fixed deadline. This corresponds with the WTO as a rules-based organisation guided by procedures and deadlines. However, Switzerland is flexible whether this extension shall be for another two or four years and will, in this regard, join Members' consensus.
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