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

H.E. Ambassador Dagfinn Sørli (Norway)

1.   I would like to thank you for the transparency report that you delivered just a few minutes ago. I think this is very much in line with the activities and the processes that were carried out during this period and certainly the references to the meetings of 30 June, 6 July, 14 July and to 20 July, the formal meeting. We would also just like to stress that the arrangement that you referred to in terms of small group meetings which were convened on the 22, 24 and 28 June and also 9 July, enabled us to have discussions on various proposals presented. I think, as you have already pointed out, going forward it would be useful, beyond this period, to revisit some of the issues that we have discussed including those around product and IP scope with respect to vaccines and diagnostics and therapeutics, as well as trade secrets and technology transfer, including the treatment of regulatory data under Article 39.3. With regard to your draft oral status report, which has now been adopted, my delegation believes that it is an objective assessment of the process up to this point. We would like to thank Members for their constructive engagement in the small group process, both on 19 and 20 July, in trying to finalise and clear some of the language that you have just read out. This is a testament to the type of compromise that we can achieve, as Members, when we are united in the goals that we try to achieve and from this perspective. I think it bodes well for our further discussions. 2.   Allow me to make a few comments in respect of our deliberations, given the fact that this is a formal meeting, and so for the record we would like to raise some issues. The co-sponsors have argued that the TRIPS waiver is a necessary, targeted and a time-bound proportionate measure directed at addressing intellectual property rights, in so far as they represent barriers to access. Passing this waiver will allow companies to ramp up and cooperate on the production of COVID-19 health products and to use health technologies without the fear of infringing another's IP rights and the attendant threat of litigation. Furthermore, passing this waiver will also act as an important political, moral and economic lever towards encouraging solutions and get global equitable access to COVID-19 health products and technologies including vaccines, therapeutics and diagnostics. 3.   The urgency of passing this waiver has not abated. We are now very close to 4.1 million fatalities, as of 19 July, and as we previously indicated, many jurisdictions are now entering a third wave with drastic increases of infections and mortalities due to new variants. The World Health Organization (WHO) has also confirmed globally that cases, and deaths have increased by 10% and 3% respectively the previous week, and this is also the case for five out of the six WHO regions, while the delta variant is now in 111 countries. We also observe that 76% of vaccinations have taken place in only ten countries, with 1.4% in Africa, 9.6% in Asia, and in the European Union we see 42.6%, the United Kingdom is at 53%, the United States is at 48.2%, and Switzerland is at 43%. This puts things into stark perspective, given the fact that only 13% of the world's population is fully vaccinated, and this leaves much room for variants to emerge and this puts lower income countries at greater risk. 4.   In the last nine months, the waiver proposal has been discussed extensively, and co-sponsors have responded to questions and requests from WTO Members, including the European Union. We have noted recently that the European parliament has approved a resolution calling for support of a pro-active, constructive and text-based negotiations for a temporary waiver at this Organization. We also would have seen in the previous week, the waiver getting support from at least 100 IP academics in an open letter which was addressed to relevant organizations. We have to also realize that intellectual property rights are not absolute, they are granted and recognised under a condition that they serve the public interest, and right now, it is in the global public interest to provide access to vaccines, therapeutics, diagnostics and other technologies that will assist us to defeat the scourge of COVID19. This is a global, not a local pandemic, and we will have to keep this in mind as we see viruses spreading and the emergence of new variants. 5.   Let me come back to some of the points that we would have raised in some of the meetings. We had an opportunity to have in-depth discussions on various aspects of the waiver proposal, including on the product scope of the waiver. We have explained that the waiver covers so-called health products and technologies and in these discussions we pointed to the fact that these terms are used in many organizations including in the terminology that the WHO uses. For instance, the term health product is inspired by the WHO Resolution on Improving Transparency of Markets for Vaccines, Medicines and Other Health-Related Products, which also include medicines, vaccines, medical devices as well as diagnostics and other assistive products which include both cell and gene-based therapies and other health technologies. Furthermore, we have emphasised the fact that testing is critical to detect cases and to investigate clusters of infections and certainly also to ascertain whether a particular approach to disease management is appropriate and successful. So it has become increasingly clear that there is also a need to expand genomic surveillance and testing for new COVID-19 variants, both to identify those variants of concern, but also to start to build vaccines and therapeutics that can prevent or treat infections. Having an arsenal of complementary means to address COVID-19 is both necessary and practical and certainly we see that this type of approach is also supported by some of the global approaches. If we look at the WHO's list of priority medical devices for COVID19, it describes a list of medical devices and equipment that would be needed to address COVID-19, and these include devices such as pulse oximeters, equipment for medical imaging, oxygen concentrators, and also includes specialised medical and surgical masks. 6.   The waiver proposal does not only deal with finished products, but it also covers so-called intermediate products, which cover materials, all their components, the methods and means of production. IP protection can prevent the supply of raw materials, components, machines and equipment, part of those machines and processes of production. So, for instance, we have recalled that raw materials are active and inactive ingredients of drug substances that are used in the formulation of therapeutics or vaccines, and reagents as in the case of diagnostics for the detection and screening of diseases, can all be subject to IP protection, which could make it much more difficult to access these particular products. We have pointed these out, and I will not repeat them, in our landscape document IP/C/W/670. We will also note, as an update, that the WHO has recently authorised tocilizumab and sarilumab for patients with severe, or critical COVID-19 infection and both these are highly priced and limited in supply in developing countries. These are subject to very high pricing, and as a result they will remain inaccessible resulting from intellectual property protection. 7.   We have also discussed, as we have indicated, the IP scope – and as we indicated – copyright, industrial designs, patents and protection of undisclosed information are all categories included in the waiver proposal. These categories of intellectual property rights are relevant, not only to the production but also to the supply and access to COVID-19 health products and technologies. Coproponents have made several submissions to highlight the relevance of addressing existing and potential IP issues in the area covered by these particular IP rights. The COVID-19 landscape is rapidly changing, and we have seen that there is an under-supply currently in respect of vaccine demand, we have seen that producers have estimated that there would be a demand between ten to 14 billion doses. We have now seen just over 3.4 billion doses having been produced. Now of course, this situation is also subject to additional doses, so-called booster doses, will be needed. We have also seen jurisdictions starting to vaccinate children. All of this puts additional stress on supply and as a result we can expect supply shortages to continue. We have also seen that, in the absence of vaccines, we may want to ramp up production of diagnostics treatments, oxygen, personal protective equipment, in order to save lives. 8.   We have also discussed the fact that the IP issues which we are faced with are complex in nature, and as a result, the waiver proposal is not just limited on patents. The revised text that we have discussed during the previous month or so also includes other types of IPRs which are essentially directed to ramp up production. We have also looked at issues around trade secrets. We, as cosponsors, believe that lifting trade secret protection is essential for expanding and diversifying global protection. For instance, by waiving trade secret protection we can start to share regulatory dossiers with potential manufacturers, and this would essentially enable existing capacity to be increased. Co-sponsors have already set out this particular dimension in document IP/C/W/673. 9.   We have also clarified the issue of duration and we have indicated that since the SARSCoV2 is a new virus, there are still many uncertainties that can affect, how the disease evolves. In order to tailor the duration of the waiver to the prevailing circumstances and the uncertainties attached thereto, the co-sponsors have specified a period of duration of three years from the date of decision and we have indicated that the waiver would not automatically terminate after three years, but only upon a review of the General Council. We have not specified any specific criteria, this is difficult to do, given the current complexity and novelty of this virus. Nonetheless, we do know that tailoring the period of a minimum of three years does accommodate at least some perspectives where it is assessed that some developing countries may have to wait three to seven years to access vaccines, so this takes these factors into account. We have also explained the relationship between the mechanisms to determinate the waiver in paragraph 2 and the early review by the General Council in paragraph 5. These two elements do not contradict each other, they can also be found in other waivers that would have been issued, for example, the waiver in document WT/L/971 with respect to the waiver of Article 70.8 and Article 70.9 of the TRIPS Agreement for LDCs. It can also be found in decision of 30 August 2003 which waived Article 31.f and 31.h of the TRIPS Agreement. 10.   On the implementation, we have also emphasised that we have a diversity of legal systems, and hence national implementation would have to take account of a country's political and constitutional arrangements. So, similarly, the parameters for implementation of the waiver would be subject to national decisions. We have indicated that there is a difference of approach between those jurisdictions that apply a so-called monist approach, and those that apply dualist approach. In the monist system international law applies directly in the national system, whereas in a dualist system, countries would still have to implement those particular provisions into their national laws, but we have seen that during this time, countries have been able to take decisions and to amend laws based either on state of the emergency that would have been declared, or disaster management legislation or the amendment of existing laws, so that it should be no different for implementing a waiver when it is passed. 11.   Let me conclude by saying that we believe, as co-sponsors, that the previous cycle of small group meetings and informal meetings of the TRIPS Council was very useful and informative. We believe a similar process can be convened after the summer break to take up issues that we have not been able to complete, or to get back to topics that require more attention. Similarly, let me take this opportunity to thank you Chair for your stewardship and leadership in this process, and for your continued support for an inclusive and transparent process.

1. The Chair said that the "Proposal for a Waiver from Certain Provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of Covid-19" had been circulated in document IP/C/W/669 by India and South Africa on 2 October 2020 and had since been co-sponsored by the delegations of Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe, Egypt, the African Group, the LDC Group, the Maldives, Fiji, Namibia, Vanuatu, Indonesia and Jordan. A revised proposal had been circulated on 21 May in document IP/C/W/669/Rev.1.
2. He said the purpose of this formal meeting was threefold: first, to report on the text-based process the Council had followed since mid-June; second, to adopt the status report to the General Council; and, third, to continue consideration of the proposals on the record, including by sharing views on how to move this discussion forward.
3. The Chair recalled that – following the formal TRIPS Council meeting on 8-9 June 2021 and subsequent consultations – he had set out a calendar and outline of an intensive text-based process in a communication circulated on 16 June 2021. This outline had foreseen an intensive schedule of meetings in various formats, including small group consultations, time for bilateral meetings among delegations, and regular open-ended meeting for all members to share information, exchange views, take stock of the situation and discuss how we should proceed.
4. Following this schedule, he had held four sessions of small-group consultations - on 22 and 28 June, and on 5 and 9 July. Informal open-ended meetings had been held on 30 June, 6 July and 14 July. Discussions at these meetings had focused on key substantive areas of the waiver proposal. These were the questions of 'scope', both from the perspective of products and from the perspective of IP rights; the questions of 'duration' and 'implementation'; and the area of 'regulatory data', which had been mentioned under many of these themes. A proposal for a draft General Council declaration on the TRIPS Agreement and Public Health in the circumstances of a pandemic, issued by the European Union on 21 June 2021 and circulated in IP/C/W/681; had also been discussed in those meetings.
5. The Chair reported that discussions in the small-group sessions had been interactive and that delegations had engaged in detailed exchanges on the substance at hand. In the area of 'scope', the co-sponsors had explained the proposed scope of the revised waiver request by illustrating the range of products and processes, as well as the sections of the TRIPS Agreement they considered relevant for prevention, containment, and treatment of COVID-19.
6. In the area of 'duration', discussions had contributed to clarifying the intended operation of the termination clause in the current text of the waiver proposal, as well as the relationship between the annual review suggested and the foreseen duration of the waiver.
7. In the area of 'implementation', discussions had focused on a number of specific questions, including the transparency of implementation, and provisions to limit the long-term impact of disclosure of confidential data during the waiver period. Delegations had also reflected on what steps would be needed at the domestic level.
8. In the area of 'regulatory data', only a few exchanges had taken place as there had not been enough time available, suggesting that delegations my need to return to this issue at a later stage.
9. The Chair said that these discussions had reflected genuine engagement and had been detailed and substantive in character. While they had helped further illuminate a number of substantive points and nuances, it was clear that disagreement remained on the fundamental question of what might be the most efficient and appropriate approach to address the shortage of vaccines and other COVID-related products. At the same time, delegations had indicated their willingness to continue discussions and had identified several topics that might merit focused discussions going forward.
10. As he had foreshadowed at that informal open-ended meeting on 14 July, he had circulated draft language for an oral status report to the General Council, with an invitation to Members to comment on this language by 16 July 2021.
11. He said that he had held further consultations on 19 July, and had circulated a revised draft status report in document JOB/IP/47 on the same day. After yet further consultations on 20 July in the morning, he had circulated a further revision in JOB/IP/47/Rev.1 which he hoped delegations would be able to adopt at this meeting. He said that the item had also been placed on the agenda of the General Council meeting scheduled for 27-28 July 2021 in the usual fashion.
12. He proposed the Council agree that he would deliver the oral status report to the General Council, circulated in JOB/IP/47/Rev.1, as follows:
At the meeting of the TRIPS Council on 15-16 October 2020, India and South Africa introduced document IP/C/W/669, requesting a waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19, which had been circulated on 2 October 2020 and has since been co-sponsored by the delegations of Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe, Egypt, the African Group, the LDC Group, the Maldives, Fiji, Namibia, Vanuatu, Indonesia and Jordan.
Since the introduction of the document, discussions took place in various formal and informal TRIPS Council meetings. Delegations exchanged views, asked questions, sought clarifications and provided replies, clarifications, and information, including through documents IP/C/W/670, IP/C/W/671, IP/C/W/672, IP/C/W/673 and IP/C/W/674, on the waiver request.
Since the last status report to the General Council on 5-6 May 2021, the co-sponsors issued a revised proposal on 21 May 2021, which was circulated in document IP/C/W/669/Rev.1. The revised waiver request was presented at an informal open-ended meeting of the Council on 31 May, and introduced at its formal meeting on 8-9 June 2021. Following the arrangement of a text-based process, discussions continued in small-group consultations, at informal open-ended meetings on 17 and 30 June, and 6 and 14 July [, and at a formal meeting of the Council on 20 July].
In the context of the text-based process, delegations held focused discussions on the topics of 'scope', both from the perspective of products and of IP rights, on 'duration', 'implementation' and on protection of undisclosed information. Delegations engaged positively and their detailed substantive exchanges helped clarify various aspects and nuances of positions. While delegations remain committed to the common goal of providing timely and secure access to high-quality, safe, efficacious and affordable vaccines and medicines for all, disagreement persists on the fundamental question of whether a waiver is the appropriate and most effective way to address the shortage and inequitable distribution of and access to vaccines and other COVID-related products.
In addition, a proposal for a draft General Council declaration on the TRIPS Agreement and Public Health in the circumstances of a pandemic, issued by the European Union on 21 June 2021 and circulated in IP/C/W/681, has also been discussed in those meetings. Delegations exchanged views, asked questions, sought clarifications and provided replies, clarifications, and information. Disagreement persists on the fundamental question of whether this proposal is the appropriate and most effective way to address the shortage and inequitable distribution of and access to vaccines and other COVID-related products.
This means that the TRIPS Council has not yet completed its consideration of the revised waiver request. The TRIPS Council will therefore continue its consideration of the revised waiver request, including through small-group consultations and informal open-ended meetings, and report back to the General Council as stipulated in Article IX:3 of the Marrakesh Agreement.
In addition, the TRIPS Council will also continue in the same manner its consideration of the other related proposals by Members.
13. The Council so agreed.
14. The Chair thanked all delegations for their support and invited delegations to take the floor to continue their consideration of the revised waiver request and the associated issues, and to share their views on how the work of the Council should be organized on this matter going forward.
15. The representatives of South Africa, Chad, on behalf of the LDC Group, Tanzania, on behalf of the Africa Group, the Maldives, the Plurinational State of Bolivia, Pakistan, Jamaica, on behalf of the ACP Group, the European Union, the United Kingdom, China, Cuba, Switzerland, Brazil, Indonesia, Chinese Taipei, the Kingdom of Saudi Arabia, Japan, Paraguay, the Republic of Korea, Singapore, the Bolivarian Republic of Venezuela, New Zealand, Turkey, the United States and India took the floor.
16. In concluding, the Chair said that he detected a willingness to continue the exchanges on substance, and that delegations had identified a number of topics as potential themes for focused discussions – including continuing deliberations on 'regulatory data', revisiting aspects related to product coverage and issues related to 'technology transfer'. He said he had also noted the cosponsors' indication that they would submit further documents on this matter. In this context he said he would not want to exclude the opportunity for delegations to exchange views in writing on any of the specific topics under discussion. He once again encouraged delegations to engage in bilateral contacts to further explore common ground in these discussions. It was his conviction that such contacts would be an essential ingredient of any substantial movement towards any solution of this issue.
17. He said the text-based process so far had been intense, and he had taken good note of delegations' comments regarding the limits of such intensity. At the same time, he was conscious of the momentum in these discussions, and the need to work towards a timely conclusion of these discussions. Against that background, it was his intention to invite delegations for an open-ended informal meeting of the TRIPS Council in early September to touch base on the state of play with a view to continuing engagement and focused discussions. He said he would discuss availability of conference facilities with the Secretariat and communicate the date for such a meeting still before the summer break.
18. The Council took note of the statements made and agreed to revert to the matter at its next meeting.
IP/C/M/101, IP/C/M/101/Add.1