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

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1. Meeting date

2. Chairperson

H.E. Ambassador Xolelwa Mlumbi-Peter (South Africa)

3. Intervention by

World Trade Organization

4. Agenda item

7 ANNUAL REVIEW OF THE SPECIAL COMPULSORY LICENSING SYSTEM (PARAGRAPH 7 OF THE ANNEX TO THE AMENDED TRIPS AGREEMENT AND PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH)

5. Statement/summary of statement

267.   We thank the Chair and delegations for their useful inputs into the debate. Let me start with the questions which were posed by South Africa, which are very pertinent. 268.   The first question concerned the definition of pharmaceutical products and whether this included vaccines. This is, of course, a very pertinent question in the current situation, as the pandemic is very much about access to vaccines if and when they become available. As usual, it is, however, not for the Secretariat to interpret relevant provisions. I would therefore turn the question back to South Africa. Is there any serious concern about vaccines not being included in the definition of a pharmaceutical product? Is there any argument being made saying that vaccines are indeed not considered to be pharmaceutical products? In relevant WHO official documents, for example, vaccines are generally included in the legal definition of a pharmaceutical product. Similarly, the WHO Good Manufacturing Practices for Pharmaceutical Products has numerous references to vaccines. So, there are indications out there about what falls within the definition of a pharmaceutical product. But again the question is: is there really any concern about vaccines not being included? 269.   The second question referred to the slide with the statistics about Members with export capacity that have implementing legislation in place, seeking an explanation as to how these statistics were put together. These have been taken from industry sources which have records on the export of pharmaceutical products on a country-by-country basis. I did compare this data with the implementing legislation that is compiled in a Staff Working Paper on the key features of WTO Members' implementing legislation regarding the Paragraph 6 System.4 That led to the figures you see on the slide concerned. While the data merit being updated, newer figures can be expected to confirm the finding that the vast majority of Members with export capacities have implementing legislation in place. 270.   The final point was about regional trade agreements and I apologise that the slide may be a bit misleading, although I did present it orally in a more concise manner. As the delegate from South Africa has rightly noted, for RTAs to benefit from the easier procedure in Article 31bis to export medicines to other Members within the RTA, they need to qualify as an RTA within the meaning of Article XXIV of the GATT 1994. The RTA needs to be composed of 50% or more of least developed countries and also the Members concerned need to share their health problems in question. However, I would rather see what has been described as a cumbersome further condition to use the System as an additional flexibility. It was built into the mechanism when it was adopted to give additional flexibility to those who at the time were most suffering from the HIV/AIDS crisis. One can therefore also see that particular derogation from a positive angle. 271.   To conclude, I just wanted to pick up on what our colleague from Chile said, i.e. that there is more need for empirical studies and evidence. Indeed, when it comes to the question as to whether the procedures are cumbersome and bureaucratic, it would actually be good to hear more about the problems and, in particular for least developed countries, the difficulties to submit a one line notification identifying the products and the quantities needed. This call for empirical evidence or studies seems therefore pertinent and maybe something to be picked up in our future work.

6. Documents referred to in intervention

7. Conclusion

The Council agreed to adopt the draft report and to attach the record of the discussion to it.

8. Summary of the agenda item (if available)

30. The Chair recalled that, in the past, the review had been conducted pursuant to Paragraph 6 System of the 2003 Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health. Since the entry into force of the Protocol Amending the TRIPS Agreement on 23 January 2017, the review also responded to the requirements that had now been incorporated into the amended TRIPS Agreement.
31. 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 System annually, with a view to ensuring its effective operation. They also required the Council to report annually on the System's operation to the General Council. In the case of the Waiver Decision, this review was also deemed to fulfil the requirements of Article IX:4 of the WTO Agreement.
32. During the Chair's consultations in September concerning Members' preferences for approaching the annual review, a number of Members had suggested that the discussion focus on concrete problems with the application of the System, rather than an abstract consideration of issues. Some had referred to procedural complexities of the System that needed to be discussed so that the System could ensure access to medicines as intended. Others had cautioned that this agenda item should not be "another COVID-19 item". One concrete proposal that had gathered broad support was the suggestion that the Secretariat give a presentation on how to use the Special Compulsory Licensing System (as opposed to how to accept the Amendment), so as to refresh delegations' memory and provide background to the discussion.
33. The Chair suggested that she would proceed by first informing Members about the status of acceptances of the Protocol Amending the TRIPS Agreement, and then give the floor to the Secretariat to provide a presentation on how to use the Special Compulsory Licensing System to remind everyone about the detail. The floor would then be open to delegations for an exchange of views about the functioning of the System, and finally, the Council would consider its Report to the General Council.
34. The Chair updated Members on the status of acceptances of the TRIPS Protocol. The current period for accepting it ran until 31 December 2021. The amended TRIPS Agreement was thus binding for 131 WTO Members. In other words, 33 Members were yet to accept the Protocol Amending the TRIPS Agreement. She encouraged those Members to complete their domestic procedures as soon as possible.
35. When the TRIPS Amendment had entered into force in January 2017, Members had noted that it would be useful to consider how to make this new procurement tool work effectively in practice. The Chair therefore encouraged Members to engage in a constructive discussion which could also build on earlier reviews. As previous Chairs and she herself had indicated on past occasions, Members might find two documents particularly helpful to facilitate their considerations. The first document was the Council's Annual Review of 2016 (circulated in document IP/C/76); and the second document was the Secretariat's 2016 Report on Technical Cooperation Activities (circulated in document IP/C/W/618). Annex II of that report summarized key issues that delegations might wish to consider to support the practical use of the System.
36. The representatives of the WTO Secretariat, Chad (on behalf of the LDC Group), Ukraine, South Africa, India, China, Tanzania (on behalf of the African Group), Japan, Australia, the United States of America, Canada, Chile, Switzerland and the European Union took the floor.
37. The Council took note of the statements made.
38. The Chair turned to the Council's report to the General Council. A draft report had been prepared by the Secretariat (circulated in document JOB/IP/38). It was modelled on previous years' reports and contained factual information on the implementation and use of the System. Under the section on the Amendment to the TRIPS Agreement, it also included a list of Members who were yet to accept the Protocol Amending the TRIPS Agreement. As with past reports, an extract from the Council's minutes on this agenda item would be attached to the report in Annex 1 and Appendix 1.
39. The Council agreed to adopt the draft report and to attach the record of the discussion to it.

9. Document symbol and date of distribution

IP/C/M/96, IP/C/M/96/Add.1

10. Footnotes

4 Available at https://www.wto.org/english/res_e/reser_e/ersd201507_e.pdf.

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