UPDATE (16 December 2020): The WTO General Council is meeting from Wednesday, 16 December 2020 to Friday, 18 December 2020 to discuss a number of matters including e-commerce, cotton, and TRIPS Council matters. Under agenda item 13, the Chair of the WTO Council for Trade-Related Aspects of Intellectual Property Rights, Ambassador Xolelwa Mlumbi-Peter (South Africa) provided a status report on TRIPS Council discussions on the proposal for a waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19 (IP/C/W/669)
The status update took the form of an oral report.
The oral report delivered by the TRIPS Council Chair on Thursday, 17 December 2020 follows.
B.STATUS REPORT ON THE CONSIDERATIONS BY THE TRIPS COUNCIL ON THE “PROPOSAL FOR A WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS AGREEMENT FOR THE PREVENTION, CONTAINMENT AND TREATMENT OF COVID-19” (IP/C/W/669) – STATEMENT BY THE CHAIR OF THE COUNCIL FOR TRIPS
Statement to be delivered orally by the Chair of the TRIPS Council:
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, Pakistan and Mozambique. [The Council continued its discussions under that agenda item at its resumed meeting on 10 December 2020.]
At those meetings, and at informal meetings on 20 November and 3 December, delegations highlighted the common goal of providing access to high-quality, safe, efficacious and affordable vaccines and medicines for all. Delegations exchanged views, sought clarifications and provided information on the waiver request but could not reach consensus. 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 and may not be able to do so within the 90 days stipulated in Article IX:3 of the Marrakesh Agreement.Therefore, the TRIPS Council will continue its consideration of the waiver request and report back to the General Council as stipulated in Article IX:3 of the Marrakesh Agreement.
On Thursday, 10 December 2020, the World Trade Organization (WTO) convened a formal meeting of the WTO TRIPS Council to discuss a waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19. This proposal is co-sponsored by: Bolivia, Eswatini, India, Kenya, Mozambique, Pakistan, and South Africa.
South Africa took the floor at around 15h00 Central European Time (CET). South Africa’s full intervention numbered over 3,700 words. The full statement can be found here: South Africa Statement at the 10 December TRIPs Council meeting
South Africa opening with the following remarks.
Madame Chair,
Thank you for giving us the floor, like others we would like to thank you for the report presented this morning as well as your efforts to facilitate discussions on the waiver proposal. At the informal meeting of 20 November and 3 December respectively, proponents reverted to questions posed by several delegations. We would like to ask that our responses during those meetings be made part of the record of today’s formal proceedings. Taken up in our intervention are some of crosscutting issues raised in document IP/C/W/671, which we will revert to in writing. Furthermore, I would like to thank all delegations that took the floor today. We have seen new members take the floor today who had not previously spoken, we are heartened by the level of engagement and welcome Bolivia to the ranks of the co-sponsors. Today some new issues arose from interventions, including questions from the delegation of Norway and Vietnam regarding possible modification of the scope of the waiver. The co-sponsors stand ready to discuss the scope of the waiver proposal. We welcome the United Kingdom’s statement regarding efforts to explore how products and technologies can be made available to the WHO C-TAP initiative. This is one of the avenues that our waiver supports in addition to all efforts to scale up production and access to COVID-19 products and technology. In the interim Madam Chair, there have also been noteworthy developments in policy guidance issued by the European Union through its IP action plan and pharmaceutical strategy which has direct bearing on our discussion in the TRIPS Council, which we will come back to later in our statement.
South Africa described bilateral procurement deals (such those negotiated by the European Union, the United Kingdom, and the United States) as reinforcing “vaccine apartheid” and enlarging “chasms of inequity.”
Those delegations opposing the waiver proposal have repeatedly suggested that voluntary approaches offer the best solution. As would have been emphasized, the TRIPS waiver proposal is supportive of any voluntary licenses issued by companies, however the terms of such licenses are often such that they may restrict access or reserve supply only for wealthy nations. Similarly, for vaccines, bilateral deals are being signed by pharmaceutical companies with specific governments but the details of these deals are mostly unknown. Usually these agreements are for manufacturing of limited amounts and solely supplying a country’s territory or a limited subset of countries. Ad hoc, non-transparent and unaccountable bilateral deals that artificially limit supply and competition cannot reliably deliver access during a global pandemic. These bilateral deals do not demonstrate global collaboration but rather reinforces “vaccine apartheid” and enlarges chasms of inequity. Disparity in access is certain to continue unless concrete steps are taken to address intellectual property barriers. If what the EU, the US and Japan is suggesting, namely that the IP system is responsible for delivery of vaccines in record time, it would fly in the face of the heroic efforts of ordinary people, researchers, scientists and government support and funding to enable this monumental feat. Not companies, but ordinary people have generously donated their skills and efforts to enable global collaboration by participating in vaccine trials, may in developing countries, putting their lives at risk for the greater good of mankind. Yet the irony does not escape us, these very people are denied priority access despite the enormous sacrifices they made.
In relation to the deficiencies of the COVAX Facility, South Africa noted the following.
We reiterate that the targets set by Act-A including the Covax is to provide 2 billion vaccine doses (for 1 billion people) to the world by the end of 2021, 245 million courses of treatment and 500 million diagnostic tests to LMICs (excluding many developing countries) in 2021 are insufficient to meet global needs of the 7.7 billion people of this world. As we seen vaccine rollouts in the developed world, we cannot but continue to wonder when equitable and timely access will become a reality, with more than 90 % of all future production of likely vaccine candidates being reserved for rich developed countries.
South Africa reminded the TRIPS Council on developments taking place at WIPO’s discussions on patents and health (on that very day) at the Standing Committee on the Law of Patents (SCP).
Up the hill at WIPO, we hear that the United States of America, has objected to the update of WIPO’s review of existing research on patents and access to medical products and health technologies to extend the publication period of studies up to 2020. In light of the destruction wrought by the COVID-19 pandemic, one wonders what the United States concerns would be regarding an updated report by the WIPO Secretariat?
In its closing remarks, South Africa focused its attention on the Pharmaceutical Strategy for Europe and the Intellectual Property Action Plan.
On the subject of the transparency of R&D costs, South Africa asked the European Union the following.
We notice the recent IP action plan and pharmaceutical strategy published by the European Commission which urges EU members to use fast track compulsory license and explore coordinated compulsory license in EU. In launching the Pharmaceutical Strategy for Europe, Vice President Schinas underscored the importance that the transparency of R&D costs plays in ensuring access to affordable medicines. In his remarks to the press on 25 November 2020, Vice- president Schinas said,
“Equally important, ensuring affordability of medicines will be guaranteed through bolstering transparency on R&D costs and expenditure on medicines in healthcare systems, finding a consensus on costing principles and addressing aspects that impede the competitive functioning of the markets impacting on affordability.“
This principle resonates well with our submission to the October 2019 TRIPS Council and the WHO Transparency Resolution (WHA72.8). Could the European Union provide more details on how it intends to ensure the “affordability of medicines” through the “bolstering of R&D costs”?
South Africa pressed the European Union to provide more details on their support of voluntary measures, including the pooling of intellectual property.
The EU IP Action Plan, released on 25 November 2020, reiterates the exigent need to deploy COVID-19 technologies, “not only in Europe but also on a global basis.” To this end, the EU IP plan calls for “voluntary pooling and licensing of intellectual property related to COVID-19 therapeutics and vaccines, in line with the recent resolution of the World Health Assembly to promote equitable global access as well as a fair return on investment.” Can the European Union elucidate further on how they intend to transform this lofty rhetoric into concrete action? The EU IP Action Plan notes that the Commission is “working on mechanisms that would enable and incentivise the rapid pooling of critical IP in times of crisis”. Could the European Union please explicate on these mechanisms that would enable the “rapid pooling of critical IP in times of crisis.”
South Africa took note of President Ursula von der Leyen’s State of the Union call for the establishment of an EU BARDA – including the provision of march-in rights.
Following on from President Ursula von der Leyen’s State of the Union call for the establishment of an EU BARDA, the EU’s IP action calls for the development of an “effective framework for march-in rights, that should guarantee that publicly funded IP is available in case of critical shortages”. Could the European Union please provide details on the design of these march-in rights?
On compulsory licensing, South Africa posed the following set of questions to the European Union.
We would counter the EU’s assertion, repeated once again today, that compulsory licensing should be used as “means of last resort and a safety net when all other efforts to make IP available have failed.” Nonetheless, could the European Union please provide further details on the EU IP Action Plan’s recommendation that EU Member States “establish fast-track procedures to issue compulsory licenses in emergency situations”?
The Commission will explore with Member States the possibility of creating an emergency co-ordination mechanism, to be triggered at short notice when Member States consider issuing a compulsory license. What is the rationale behind this policy decision?
In the European Union, data exclusivity and on certain products market exclusivity are granted. How does the EC want to make effective use of CL in this pandemic with these non-patent barriers in place?
As the European Union has opted out of Article 31bis of the TRIPS Agreement, how would EU member states with no or insufficient manufacturing capacities make effective use of the compulsory licensing provisions of the TRIPS Agreement, especially in light of the IP Action Plan’s emphasis on establishing “fast-track procedures to issue compulsory licenses in emergency situations”?