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

H.E. Ambassador Dr. Lansana GBERIE

115.   On 15 June 2021, the Directors General of the World Health Organization, World Intellectual Property Organization and the World Trade Organization issued a joint statement in which they underscored their "commitment to universal, equitable access to COVID-19 vaccines, therapeutics, diagnostics, and other health technologies". The three DGs underlined that this commitment is anchored in the understanding that this is an urgent moral imperative in need of immediate practical action. 116.   We have learnt from the experiences of this pandemic that it is critical to scale up production and access to not only vaccines, but other tools, including therapeutics and diagnostics to prevent the spread of COVID-19 and to treat the disease and prevent deaths. These resources have been in acute shortage in many countries leading to very limited accessibility. The scope of products is also reflective of the national COVID-19 response strategies of many countries that acknowledge that the prevention, treatment and containment of COVID-19 involves a range of health products and technologies. Vaccines are necessary but not sufficient to respond to the pandemic. No country adopts only one intervention in this and any pandemic. Vaccinations, test and treat strategies and their related health products and technologies are urgently needed alongside other interventions. 117.   In relation to therapeutics, WHO's consultations on COVID-19 therapeutics reveal that "[d]espite the great success of COVID-19 vaccine development, therapeutics are still urgently required" and that a range of therapeutics will be required including "drug combinations targeting specific aspects of infection, as well as suites of treatments targeting different disease processes (such as antivirals, immunomodulators and anti-coagulants)".2 The European Union COVID-19 therapeutic strategy also states that "vaccines will not eliminate the disease overnight and therapeutics will still be needed for patients in hospitals and at home, including people suffering from 'long COVID'. For these reasons, therapeutics will continue to play a significant role and complement the EU strategy for vaccines." Notably, several therapeutics have been approved, registered and have received national emergency use authorization or qualified for the WHO emergency use listing. 118. Since the currently available vaccines are not able to prevent infections, therapeutics play an important role in our effort to contain and treat COVID-19. In document IP/C/W/670, the co- sponsors have presented a preliminary patent landscape providing a non-exhaustive snapshot of the patent filing and granting status of five selected therapeutics candidates for COVID-19. In document IP/C/W/672 as well as in document IP/C/W/673 the co-sponsors have highlighted IP‑related challenges in the area of therapeutics and how restrictive voluntary licensing practices continue to pose supply challenges to countries. The WIPO patent landscape report has subsequently shed further light. 119. In relation to diagnostics, pillar 5 of WHO's Strategic Preparedness and Response Plan for COVID-19 considers testing to be the cornerstone of the management of the COVID-19 pandemic. Testing is critical to detect cases and investigate clusters of cases so that public health actions can be rapidly taken to isolate those infected, quarantine contacts and break chains of transmission. Testing allows for new COVID-19 variants to be identified to begin to build vaccines and therapeutics that can prevent or treat infection. Major gaps in testing are still putting lives at risk and threatening progress to end the pandemic. There is therefore a need to scale up testing and ensure immediate, equitable access to diagnostic tools in every country across the world. The co-sponsors have provided examples highlighting IP challenges in previous TRIPS Council meetings (see paragraphs 42-46 of document IP/C/W/672 as well as paragraph 65 of document IP/C/W/673). 120.   We commend Dr Ngozi Okonjo-Iweala, Director-General of the WTO, for the work undertaken towards the Ministerial Decision on the TRIPS waiver. Work conducted within the Secretariat such as the "Working Paper on Patent Related Actions Taken in WTO Members in Response to the COVID- 19 Pandemic" as well as the "Working Paper on Innovation and Patenting Activities of COVID-19 Vaccines in WTO Members: Analytical Review of VaxPaL", both provide rich information that Members may use in developing appropriate measures within their jurisdictions. Paragraph 8 of that Decision contains a clear Ministerial mandate for Members to decide on extension of the Decision to therapeutics and diagnostics within 6 months – that is, by 17 December 2022. 121.   The co-sponsors have prepared a room document that sets out why it is important to expeditiously fulfil the paragraph 8 mandate. The room document also proposes a time frame for the consideration of the membership, aimed at assisting us to timeously fulfil the mandate set by Members at MC12. The time frame is indicative, and it has just been brought to my attention that 22 July is the last day of the WIPO General Assembly. Obviously this would have an impact on the ability of some delegation to participate, so this is indicative and we are happy for Members to reflect and provide a time frame that would be workable. 122.   As stated by Dr Ghebreysus, Director-General of the WHO, "Vaccines alone will not end the pandemic". "Many countries need diagnostics, lifesaving therapeutics – including oxygen and support for vaccine rollout." The WTO membership has urgent work to do in order to emulate the commitment to universal, equitable access to COVID-19 vaccines, therapeutics, diagnostics, and other health technologies demonstrated by the trilateral DGs. Extension of the WTO Ministerial Decision on the TRIPS Agreement to cover therapeutics and diagnostics will be a significant step in the right direction. 123.   We have heard some mention voluntary licenses as an alternative to full use of TRIPS flexibilities and extension of the Ministerial Decision on the TRIPS Agreement. Here I would state that our delegation appreciates the value of voluntary licenses. However, due to various limitations, voluntary licenses cannot be considered as the only means that Members should have at their disposal if we are to diversify production on an adequate scale. Some of the limitations involved with licensing include: lack of transparency, geographical limitations, and exclusivity. 124.   South Africa is a co-sponsor of the Solidarity Call to Action and the WHO COVID-19 Technology Access Pool (C-TAP) together with 41 other countries. At the early stages of the pandemic, the Call to Action made three requests of holders of knowledge, intellectual property or data to existing or new therapeutics, diagnostics and vaccines, including. Namely, that they: a. Voluntarily license such rights on a non-exclusive and global basis to the Unitaidestablished and supported Medicines Patent Pool and/or through other public health research and development mechanisms, consortia or initiatives that facilitate global and transparent access; and/or voluntary non-enforcement of intellectual property rights, as appropriate, during the COVID-19 pandemic, to facilitate the wide-scale production, distribution, sale and use of such health technologies throughout the world; b. Facilitate equitable, affordable and timely access to their products for all countries; and c. Share voluntarily the relevant knowledge, intellectual property and data to enable widescale and worldwide production, distribution and use of such technologies and necessary raw materials through mechanisms such as the Technology Access Partnership (TAP) hosted by the UN Technology Bank or the Open COVID Pledge Initiative3. 125.   These requests were largely unheeded, which has contributed to the concentration of production in a few locations and inequitable access to COVID-19 tools. The co-sponsors have consistently argued that business as usual approaches are ill-suited to situations of extreme urgency such as pandemics. We have also called for vigilance given the ever-present threat of new variants and sub-variants. The emergence of the highly transmissible BA.4 and BA.5 Omicron sub-variants as well as the BA.2.12.1 sub-variant, which was first detected in the United States of America in December 2021, have resulted in spikes in the number of infections in different regions. The impact of these spikes is yet to be determined but there are some initial indications that the risk to global health presented by the latest sub-variants is potentially greater than that of original BA.2. The ability to identify and treat these variants and sub-variants as well as those which continue to emerge will depend on the deconcentrated availability of therapeutics and diagnostics. Extension of the WTO Ministerial Decision to cover these crucial COVID-19 tools is urgent and will be a key facilitator in this regard.

This Council took note of statements made and agreed to revert to this matter at its next meeting.
52. The Chair recalled that on 17 June 2022, the 12th Ministerial Conference had adopted a Ministerial Decision on the TRIPS Agreement which aimed to improve the capacity of developing country Members to produce and supply COVID-19 vaccines to other eligible Members. Paragraph 8 of the Decision provided that no later than six months from the date of this Decision, Members would decide on its extension to cover the production and supply of COVID-19 diagnostics and therapeutics.
53. The Chair recalled that barely three weeks had passed since the Ministerial Conference, which was concluded on 17 June, and that some were still recovering from the intense negotiations. He did not expect that Members had had time to prepare an in-depth position on the complex question of extending this decision to additional products, such as therapeutics and diagnostics. He also recalled from the negotiations during the 12th Ministerial Conference, that one reason for postponing a decision on extension to 6 months after adoption was that certain Members did not have a mandate to consider covering diagnostics and therapeutics, and that they would need the six months for discussions in their domestic arena to obtain such a mandate. He therefore assumed that Members would need time to prepare their engagement in this regard. and what could be expected at this first consideration of the topic would be a sharing of views on how best to approach the matter going forward.
54. The representatives of South Africa; Uruguay; Pakistan; Maldives; Ukraine; Egypt; Tanzania; Bangladesh; Indonesia; Argentina; Sri Lanka; China; India; the Russian Federation; Hong Kong, China; Chile; Bolivia, Plurinational State of; Australia; Brazil; the United Kingdom; Singapore; Norway; Canada; Japan; Korea, Republic of; the European Union; Malaysia; the United States; New Zealand; Nicaragua; Thailand; Switzerland; Panama; Mexico; and Peru took the floor.
55. The Chair said he had carefully listened to Members' views on how work in the Council should proceed on this very important matter. He said he recognized, as many delegations had, that this was a ministerial decision with a tight timeline and that the matter therefore needed to be treated with urgency. He also recognized that a number of delegations needed to consult with their capitals in order to agree on a proper framework for this decision.
56. He confirmed that there was a commitment by the Council to keep this matter alive until the decision was finalized. As regards reporting to the General Council, he noted that the next meeting was scheduled for 25-26 July, which was only 20 days away, and that therefore chances were slim that the TRIPS Council would have a lot to report by that time, given also that other meetings like the WIPO Assemblies were taking place in the meantime. Against this background, he suggested that it would be the best use of time if Members themselves brought their assessment of the discussions to the attention of the General Council during the next meeting.
57. With respect to continuing discussions, which he as Chair was committed to, he said it was important for meaningful discussions to start as soon as delegations were ready to engage on the substance of this rather complex question. It was important to carefully balance the urgent need to take this decision before the deadline in December as well as the time for domestic consultations necessary for some to proceed. In designing the proper framework on how to engage in this process it was also important to ensure that discussions were open, inclusive and transparent - as had been emphasized by many delegations.
58. He said that the experience of the negotiations leading to the Ministerial Decision suggested that, in the meantime, bilateral discussions and small group discussions could be extremely helpful to work out a proper framework around which a decision could be constructed by consensus – which remained an absolute requirement with respect to decisions by the Council and by the WTO. He therefore encouraged bilateral and small group meetings in the meantime, and said that this certainly remained a very active matter, that it would be properly discussed and the decision arrived at within the timeframes set by the ministerial decision.
59. This Council took note of statements made and agreed to revert to this matter at its next meeting.
IP/C/M/105, IP/C/M/105/Add.1, IP/C/M/105/Corr.1

2 P. 5 https://cdn.who.int/media/docs/default-source/blue-print/06_therapeutics_full-achievements-report.pdf?sfvrsn=d6cdb802_3&download=truereport.pdf?sfvrsn=d6cdb802_3&download=true. See also pp. 12 and 13.

3 https://www.who.int/initiatives/covid-19-technology-access-pool/solidarity-call-to-action.