H.E. Ambassador Dagfinn Sørli (Norway)

Sri Lanka

1 PROPOSAL FOR A WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS AGREEMENT FOR THE PREVENTION, CONTAINMENT AND TREATMENT OF COVID-19

98.   First let my delegation congratulate you on your election as the Chair of this Council at this very crucial juncture, and equally wish to commend my dear colleague Ambassador Xolelwa Mlumbi-Peter for her contribution made and services rendered to this body. By saying it, my delegation's support is extended to you at all times. 99.   My country's situation in relation to positive cases is becoming dreadful, having reported over more than 1,000 cases per day consistently for the last one week. This is unprecedented and hospitals in populated areas are witnessing stressed situations in terms of the occupancy rates. This is despite having vaccinated a sizable population in mostly concentrated and densely areas. 100.   The AstraZeneca vaccines, which have already been administered to close around 1 million people in Sri Lanka, including frontline and health workers, are responding well to the new variant of COVID-19, which is rapidly spreading in the country at present, indicating that the country is going through its third waive. 101.   Officials said that to date, there had hardly been any cases of those who had received the first dose of vaccination to have contracted the new variant of the COVID-19, but in future, even if they do face a threat of being infected, they will have a very low chance of advanced disease or complications. 102.   Basically all the vaccinations which are available in the world today are responding well to all the variants of the COVID-19 including the mutated versions. In fact a recent study carried out by one of the Universities in Sri Lanka shows that those vaccinated have better immunity than even those infected. That is why it is extremely important that everyone is vaccinated, vaccinations coupled with other health measures are the only way out for us. 103.   Meanwhile, as discussions continue to purchase more AstraZeneca doses, health experts said that with more mutated versions now spreading rapidly globally, a third vaccination dose known as the 'booster' might need to be administered in the future. Experts were discussing this possibility and we heard that manufacturers are gearing up to cater to the third vaccine. 104.   Sri Lanka has been working closely with India to sign agreements to purchase adequate doses from the Serum Institute in India under commercial terms, as this generic version AstraZeneca vaccines can be procured at rates affordable to our government. 105.   But due to the current situation in India, our friendly neighbour, which is around the clock trying hard with much vigour to contain the spread the infections and save its population, we are not certain whether Sri Lanka will be able to procure the required amount to vaccinate at least 44% of our population while also using the doses assured under the COVAX initiative. 106.   In instances where no patent holder of available vaccines is willing to negotiate provision of the required doses to Sri Lanka at rates affordable to us, Sri Lanka is seriously mulling over as to how it can import and procure the vaccines under compulsory licenses. 107.   This is because, Sri Lanka has not introduced the required amendments to its National IPR Act to give effect to the Article 31bis of the TRIPS Agreement. This is aggravated further, knowing well that Sri Lanka is also not having clear provisions to procure the vaccines under parallel imports (under Exhaustion of IP rights), even if there are vaccines available in other third country markets, which we know will not be realistic at present given the severe shortage prevailing on the supply side. 108.   I am therefore conveying the situation, which my country will be facing very soon, if we do not have a multilateral solution by way of this waiver to address the difficult situation likely to be faced by countries such as mine. If we cannot have a solution to this impasse soon, Sri Lanka may be compelled to submit a country-specific request to the WTO seeking to waive its relevant TRIPS obligations, enabling it to take an array of measures, including issuance of compulsory licenses to those generic manufactures in the world who can supply the required quantities at this time of the hour. 109.   As we know there are generic manufactures having manufacturing capacity, who can cater to our requirements, provided they are permitted to do so under compulsory licences which Sri Lanka will be able issue under the waiver. Any delay in launching such initiatives by my government will have severe and unimaginable consequences on my country. 110.   We are very certain that the waiver proposal promises to help large populations in developing countries and particularly countries such as mine not having manufacturing capacity hence is compelled to rely on imports, but would also allow export of medicines and medical equipment to other needy developing countries in the future where demands could remain unfulfilled otherwise, if we can gradually build the production of capacity over the years. 111.   It is high time we listen to the countless calls outside the WTO premises from all walks of life, for global solidarity and cooperation to help fight the pandemic which threatens humanity. We are open and look forward to more meaningful engagement from members at this juncture, that aims at finding constructive solutions to address this issue. 112.   We have had sufficient and lengthy debate on the issue of the waiver. The co-sponsors made the case in great detail describing the various challenges and problems which necessitate this waiver. The time is now ripe for a more forthright, solution-finding approach, which is to proceed on textbased negotiations based on the texts before us and to be presented sooner than later. This will be the most significant contribution that the WTO could make towards fighting the pandemic, saving human lives and helping lower-middle income countries and LDCs.

The Council took note of the statements made and agreed to revert to the matter at its next meeting.

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 and Namibia. He said the purpose of this formal meeting was threefold: first, to report on his activities since he had taken office; second, to adopt the status report to the General Council; and third, to continue consideration of the waiver proposal on the record.
2. The Chair said that, since his election at the end of the TRIPS Council meeting on 11 March, he had held a number of consultations with delegations in different formats to encourage more solutionoriented discussions and to explore in concrete terms whether a possible landing zone could exist.
3. On 24 March 2021 he had held group consultations with around 24 delegations on the waiver request and other topics where he solicited delegations' views on how to move discussions forward and find a common approach to this topic. Delegations' responses in these consultations had reiterated known positions and showed some frustration with the repetitive nature of exchanges in the recent open-ended meetings. A number of delegations had indicated a willingness to try a format of smaller consultations to address outstanding issues.
4. Following up on these indications, the Chair had held two small group consultations with 14 delegations on 12 and 13 April to permit discussing individual aspects of the waiver proposal in a smaller setting. The first session focused on "examples of IP-related challenges, including in using TRIPS flexibilities", while the second session intended to address the "operation of the proposed waiver". These discussions clearly showed delegations' agreement that production and distribution of COVID-19-related medical products, including vaccines, are facing serious challenges and that rapid scaling-up of production and ensuring safe supply of all countries is essential. Delegations also shared the common goal of providing timely and secure access to high-quality, safe, efficacious and affordable vaccines and medicines for all.
5. However, delegations continued to differ on the fundamental question whether, and to what extent, intellectual property protection represents barriers or challenges to the achievement of our common objective, which could not be overcome by using the existing flexibilities. Co-sponsors were of the clear opinion that such challenges do exist and can only be effectively addressed by waiving certain TRIPS obligations. Other delegations remained unconvinced about the necessity of a waiver at the international level, with some arguing that a waiver might be counterproductive in relation to ongoing collaborative efforts.
6. He said that, in his intervention at the Director General's event "COVID-19 and Vaccine Equity: What can the WTO contribute?" on 14 April, which had been circulated to all delegations, he shared that assessment and indicated that these in his opinion, remained the key questions. In her summary of that event, the Director General also called on WTO Members to advance work in the TRIPS Council "on the waiver proposal and on incentives for research and innovation" and expressed her hope that the ideas and the open dialogue heard at the event will move us closer to agreement.
7. He said that Members had continued their consideration of the waiver request at an informal open-ended meeting on 22 April 2021. At that meeting, many exchanges had reiterated known positions regarding the role of voluntary licensing in scaling up production of vaccines, and the application of existing TRIPS flexibilities in domestic situations of vaccine shortages in the pandemic. However, the co-sponsors had also indicated that they were working on an updated waiver proposal, and that they had initiated bilateral discussions in this regard. A number of delegations also requested the Secretariat to compile data on existing and future voluntary license agreements, and on the projected and actual production of vaccine doses produced by such arrangements over time.
8. Other delegations had acknowledged the co-sponsors' responses to questions circulated in recent documents but felt that questions posed subsequently – particularly with respect to the operation of a potential waiver – remained unanswered. While these delegations had reiterated that cooperation and voluntary licensing were key to ensuring the technology transfer needed for scaling up production, they said it was equally clear that governments do play a role in facilitating such cooperation, and that the use of TRIPS flexibilities such as compulsory licensing was the sovereign right of all WTO Members. Some had considered whether there might be value in a confirmation by the TRIPS Council how these flexibilities apply in a pandemic, and in stepping up technical support for Members to use them, including by reinforcing cooperation with other international organizations on domestic implementation legislation of flexibilities. Overall, it was his impression that although significant differences remain, there was willingness on all sides to find a constructive consensual approach to these questions.
9. The Chair said that, as also foreshadowed at that informal open-ended meeting on 22 April, 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 26 April 2021. Having received no textual comments in this regard, this draft status report had been circulated in document JOB/IP/44 on 27 April 2021, which he hoped delegations would be able to adopt at the present meeting. He informed Members that the item had also been placed on the agenda of the General Council meeting scheduled for 56 May 2021 in the usual fashion. This concluded his summary of the Council's activities since our last formal meeting.
10. Turning to the language for the oral status report to the General Council which had been circulated in document JOB/IP/44 on 27 April 2021, he said that Fiji and Namibia had recently been added as co-sponsors of the waiver proposal, and suggested that this be also reflected in the first paragraph of the status report for the purposes of accuracy.
11. He proposed the Council agree that he would deliver an oral status report to the General Council 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 and the LDC Group, the Maldives, Fiji and Namibia. The Council continued its discussions under that agenda item at informal meetings on 20 November and 3 December, as well as at its resumed meeting on 10 December 2020. Following the status report to the General Council on 16-17 December 2020, the Council continued its consideration of the waiver request at informal meetings on 19 January and 4 February 2021, and at its formal meeting on 23 February 2021. Following the status report to the General Council on 3-4 March 2021, the Council continued its consideration of the waiver request at its formal meeting on 1011 March 2021, at an informal meeting on 22 April and at its formal meeting on 30 April 2021.
At those meetings, delegations highlighted the common goal of providing timely and secure access to high-quality, safe, efficacious and affordable vaccines and medicines for all. 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 but could not reach consensus, including on whether it is appropriate to move to text-based negotiations. In April 2021, the co-sponsors indicated that they were considering an update of their proposal and were in the process of consulting with Members. Delegations indicated a need for further discussions on the waiver request and views exchanged by delegations.
This means that the TRIPS Council has not yet completed its consideration of the waiver request. The TRIPS Council will therefore continue its consideration of the waiver request and report back to the General Council as stipulated in Article IX:3 of the Marrakesh Agreement.
12. The Council so agreed.
13. The Chair thanked all delegations for their support in this regard. He gave the floor to the Secretariat to react to the requests for data collection and compilation that were raised at the last informal meeting.
14. A representative of the Secretariat took the floor.
15. The Chair invited delegations to take the floor to continue their consideration of this 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.
16. The representatives of South Africa, Egypt, Bolivia, India, Maldives, Tanzania on behalf of the African Group, Chad on behalf of LDC Group, Pakistan, Zimbabwe, Bangladesh, Nepal, Saudi Arabia, Tunisia, Nigeria, Sri Lanka, Namibia, Fiji, China, Vanuatu, Switzerland, Paraguay, European Union, Uruguay, United Kingdom, Indonesia, Chinese Taipei, Cameroon, Singapore, New Zealand, Japan, Australia, the United States, and Angola took the floor.
17. In summing up, the Chair said that he had heard some well-known views and positions repeated also at this meeting so that the assessment of the state of play reflected in the oral status report to the General Council was indeed correct. At the same time, he also saw reason for some careful optimism, first and foremost as a result of the co-sponsors' announcement that they are considering revisions to the waiver proposal, and that they were currently consulting with other Members on the basis of such revisions. He noted the co-sponsors' request for time to continue such consultations to reflect on what they heard, and to develop a revised proposal on that basis, which – as they indicated – might be circulated in the second half of May. He said he would stay in close contact with the delegations concerned, consult them on the progress of their efforts, and would try to find a suitable timing for such a meeting, which would be communicated to all Members as it becomes clearer.
18. He noted and commended delegations on their expressed willingness to engage directly with each other - and encouraged constructive engagement on all sides in these engagements.
19. The Council took note of the statements made and agreed to revert to the matter at its next meeting.

IP/C/M/99, IP/C/M/99/Add.1