TRIPS waiver

The EU – AU Summit and the promise of a resolution to the WTO pandemic response package

The sixth European Union – African Union summit took place last week in Brussels on February 17-18. The summit covered a broad array of topics including access to vaccines. It followed an event on vaccine equity in Africa hosted by BioNTech and the kENUP Foundation on the 16th which announced the schedule for shipping facilities to several African countries to produce mRNA vaccines in the second half of 2022. See February 16, 2022:  Building Vaccine Capacity in Africa – Exciting News from BioNTech, https://currentthoughtsontrade.com/2022/02/16/building-vaccine-capacity-in-africa-exciting-news-from-biontech/.

The Summit was an effort to have the two Unions form a new partnership, and for the EU to be the partner of choice for countries in Africa. The joint declaration from the summit is included below and reviews the broad areas of discussion and agreed actions to be taken by the two Unions following the Summit.

final_declaration-en

The discussion of the COVID-19 pandemic and the ongoing discussion on the WTO’s consideration of a response to the pandemic (both trade and intellectual property) was one of the important issues at the summit. The joint declaration discussion of the issue is copied below.

“The immediate challenge is to ensure a fair and equitable access to vaccines. Together we will support local and regional mechanisms for procurement, as well as allocation and deployment of medical products. The EU reaffirms its commitment to provide at least 450 million of vaccine doses to Africa, in coordination with the Africa Vaccine Acquisition Task Team (AVATT) platform, by mid-2022. Contributing to this and complementing the actions of the AVATT, Team Europe has provided more than USD 3 billion (i.e. the equivalent of 400 million vaccine doses) to the Covax Facility and to vaccination on the African continent.

“Team Europe will mobilise EUR 425 million to ramp up the pace of vaccination, and in coordination with the Africa CDC, to support the efficient distribution of doses and the training of medical teams and the capacity of analysis and sequencing. We will also contribute in this context to the fight against health-related disinformation.

“Learning from the current health crisis, we are committed to supporting the full-fledged African health sovereignty, in order for the continent to respond to future public health emergencies. To this end, we support a common agenda for manufacturing vaccines, medicines, diagnostics, therapeutics and health products in Africa, including investment in production capacities, voluntary technology transfers as well as strengthening of the regulatory framework to enable equitable access to vaccines, diagnostics and therapeutics.

“The African Union and the European Union underlined the urgency of the WTOs contribution to the fight against the pandemic and to the recovery of the global economy, and commit to engage constructively towards an agreement on a comprehensive WTO response to the pandemic, which includes trade related, as well as intellectual property related aspects.”

The European Commission’s President Ursula von der Leyen statement at the press conference on February 18 provided the timeline for reaching agreement with the African Union on the WTO response package to the COVID-19 pandemic, including finding an acceptable path forward on intellectual property. The EU and AU will be meeting in the Spring to find a mutually acceptable solution. President von der Leyen’s comments at the press conference on this topic are copied below.

“And finally, from the health of our planet, to the health of our people. Europe is Africa’s number one
partner in the fight against COVID-19. And we will do even more. We are on the right track to reach
our goal to share at least 450 million vaccine doses by this summer. And indeed, together, we are
building up mRNA manufacturing capacity across Africa. I will not go in detail because we have
discussed that in the press conference this morning.

“But important is that we had a very good, intense, constructive discussion on the question of TRIPS
waiver and compulsory licencing. We share the same goal. We have different ways to reach that goal.
There must be a bridge between those two ways. And therefore, we have decided that the two
Commissions – the African Union Commission and the European Union Commission – will work
together. We will organise a College-to-College meeting here in Brussels, in spring. And at that time,
at the latest, we have to deliver a solution. This will be accompanied by the WTO, Director-General
Ngozi. And therefore, I always like it when a task is clear and defined. The task is set for the two
Commissions. The frame is clear, the goal is clear, we have to deliver.”

Statement by President von der Leyen at the joint press conference following the 6th European Union-African Union Summit, Brussels, 18 February 2022, https://ec.europa.eu/commission/presscorner/detail/en/STATEMENT_22_1181.

The European Union has been working for most of the last year on moving towards significant vaccine production capacity being built in Africa. President von der Leyen’s statements at the start of the EU-AU Summit and her statement at the Vaccine Equity for Africa event on February 16 provide significant detail on actions the EU is taking to help Africa develop vaccine manufacturing capacity as well as address the build up of health care infrastructure on the continent. See Opening speech by President von der Leyen at the 6th European Union-African Union Summit, Brussels, 17 February 2022, https://ec.europa.eu/commission/presscorner/detail/en/SPEECH_22_1142; Statement by President von der Leyen at the‘Vaccine Equity for Africa’ launch event, co-organised by BioNTech SE and the kENUP Foundation, 16 February 2022, https://ec.europa.eu/commission/presscorner/detail/en/STATEMENT_22_1105.

Parts of the February 16 speech are copied below.

“This year already, at least two of these container factories will move to Africa. To Rwanda and to Senegal, where I visited last week the Institut Pasteur de Dakar. Close cooperation is ongoing with South Africa’s Biovac Institute. And with our partners in Ghana. We are advancing in record time. Commercial production is set to begin in 2023. 

“The ‘Vaccine Equity for Africa’ project is only possible thanks to teamwork. Starting with Africa’s declared ambition to build its own vaccine production capacity. Teaming up with a European innovation champion such as BioNTech. Supported by the European Union and the African Union. Governments in Europe and Africa. And the UN system. This is how we emerge from the pandemic and build a stronger future for Africa and Europe.

“The initiative is first and foremost about vaccine equity. Vaccines from the new factories will be sold at not-for-profit prices, exclusively to African countries. They will be made in Africa, for Africa, with world-class technology.

“At the same time, this initiative can advance public health and industry, well beyond the pandemic. We know the mRNA technology is revolutionary. It holds promises for the fight against other diseases, like malaria and tuberculosis. BioNTech factories can be adjusted within weeks to make different vaccines. It could thus be an African-made solution to diseases that currently kill millions.

“This project is part of a larger ambition. By 2040, the African Union wants that 60% of the vaccines used on the continent are manufactured on the continent. The European Union fully supports that goal. Together with our Member States and financial institutions, we have committed over one billion euros in financing. To strengthen regulatory frameworks, and transfer skills and know-how. Because regional capacities are the cornerstone of global public health.

“And the project goes even beyond public health. Building this technological capacity in Ghana, Rwanda, Senegal and South Africa – countries that are regional leaders in innovation – will strengthen the innovation ecosystem on the entire continent.”

Documents from the European Council and European Commission at the conclusion of the Summit provide the EU’s view of the healthcare portion of the summit and EU actions. See European Council, Council of the European Union, First technology transfer of mRNA vaccines: Working together to build new solutions, 18 February 2022, https://www.consilium.europa.eu/en/european-council/president/news/2022/02/18/20220218-mrna-vaccines-technology-transfer/ (“In the margins of the European Union-African Union Summit, the World Health Organisation (WHO) announced the first six countries that will receive the technology needed for the production of mRNA vaccines on the African continent. Egypt, Kenya, Nigeria, Senegal, South Africa and Tunisia all applied and have been selected as recipients. The announcement was made at a ceremony hosted by the European Council, France, South Africa and the WHO in the presence of the following leaders: Charles Michel, President of the European Council, Ursula von der Leyen, President of the European Commission. President Macron, President Ramaphosa, President Sall, President Kenyatta, President Buhari, President Saïed and  President al-Sisi.”); European Commission, EU-Africa: Global Gateway Investment Package – Health, factsheet, 9 February 2022,https://ec.europa.eu/commission/presscorner/detail/en/fs_22_870.

While vaccines and health issues were just one of a number of important topics reviewed during the Summit, it has been the focus of this post simply because the outcome and promised meeting in the Spring between the two Unions offers the hope of a resolution to the WTO’s ongoing negotiations on a pandemic response package — one that covers various trade actions as well as what, if any, actions are needed on intellectual property rights during a pandemic. While the member states of the EU and the AU are not the only parties with strong positions in the ongoing discussions at the WTO, it would seem likely that if the EU and AU are able to reach agreement on a package that will likely form the basis of a final resolution in Geneva.

With the WTO apparently discussing dates in June 2022 for rescheduling the 12th Ministerial Conference, the ability of the EU and AU countries to find a mutually agreeable solution to the intellectual property component of the pandemic response package could permit an agreed package to be accepted by WTO Members at the Ministerial Conference. See Inside U.S. Trade’s World Trade Online, World Trade Organization now eyeing June for 12th ministerial, February 18, 2022, https://insidetrade.com/daily-news/world-trade-organization-now-eyeing-june-12th-ministerial. The announcement last week of the Spring effort to reach agreement may also help facilitate movement on fisheries subsidies at the WTO — a negotiation that has been ongoing for more than 20 years.

In short, the EU-AU Summit while covering a lot of ground on issues of importance to both Unions may also have created a path to forward movement at the WTO on the response to the pandemic and more ahead of the 12th Ministerial Conference.

Actions by the US, EU, Quad (US, Japan, India, Australia), China and others should ensure that there are more than adequate vaccines available in 2022 to vaccinate all countries against COVID-19. Efforts by the WHO, GAVI, the U.S., EU and others are also likely to significantly increase the ability of countries in Africa to vaccinate their populations. Thus, the real benefit of resolving the WTO pandemic response at the 12th Ministerial will not be responding to COVID-19 but rather adopting rules and policies that will make the world more responsive to future pandemics.

We wish the EU and AU well in their upcoming negotiations.

The WTO’s efforts to address the COVID-19 pandemic — will Members reach agreement by the end of February?

Throughout the current pandemic, the WTO has generated large amounts of information to help Members examine the response to the pandemic that would minimize disruptions and maximize availability of medical goods. See, e.g., WTO webpage and series of reports generated by the Secretariat (WTO, COVID-19 and world trade, https://www.wto.org/index.htm; https://www.wto.org/english/tratop_e/covid19_e/covid19_e.htm. The WTO Secretariat provides periodic updates on reports as well as tracking import and export restrictions on medical goods and inputs. See, e.g., WTO news, WTO Secretariat updates members on COVID-19 reports and new tools, 28 January 2022, https://www.wto.org/english/news_e/news22_e/nama_28jan22_e.htm.

With support from WTO Members, the WTO has worked with other multilateral organizations to promote a coordinated response. See, e.g., WTO press release, WHO, WIPO, WTO heads chart future cooperation on pandemic response, 1 February 2022, https://www.wto.org/english/news_e/news22_e/igo_01feb22_e.htm; WTO press release, International organizations discuss how to improve access to COVID vaccines, countermeasures, 22 December 2021, https://www.wto.org/english/news_e/news21_e/covid_22dec21_e.htm (IMF, World Bank, WHO, WTO); WTO-IMF COVID-19 Vaccine Trade Tracker, Last updated: 17 January 2022, https://www.wto.org/english/tratop_e/covid19_e/vaccine_trade_tracker_e.htm.

Most WTO Members view agreeing on a multilateral response to the pandemic as of critical importance. This includes both addressing a host of non intellectual property issues [“These include issues relating to trade facilitation, export restrictions, regulatory coherence, transparency and monitoring, scaling-up of production and distribution on essential goods, services and crisis preparedness and resiliency, and coordination with relevant stakeholders, including international organizations and the private sector.”] and resolving whether there should be a waiver from some TRIPS obligations as requested by India, South Africa and supported by others. The WTO Secretariat put out a briefing note on the issue of trade and health looking at the state of play as of 6 January 2022. See Trade and health: WTO response to the COVID-19 pandemic, 6 January 2022 (above quote is from the briefing note), https://www.wto.org/english/thewto_e/minist_e/mc12_e/briefing_notes_e/bftrade_and_health_e.htm.

As I have reviewed in prior posts, the waiver of TRIPS obligations proposal from India and South Africa has been challenging for a number of Members to accept. See, e.g., WTO efforts to address the COVID-19 pandemic — the January 10, 2022 General Council meeting and some current developments of interest, https://currentthoughtsontrade.com/2022/01/11/wto-efforts-to-address-the-covid-19-pandemic-the-january-10-2022-general-council-meeting-and-some-current-developments-of-interest/. The briefing note provides a good summary of the TRIPS waiver proposal and is copied below.

“TRIPS Council

“In parallel to the process facilitated by Ambassador Walker, members have been seeking convergence on how best to use the global intellectual property (IP) system to tackle COVID-19 in the context of the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS).

“Waiver request

“Over the past year, members have engaged in discussions based on various texts. On 15-16 October 2020, India and South Africa introduced at the TRIPS Council document IP/C/W/669 requesting a waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19. The proposal 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 have taken place in various formal and informal TRIPS Council meetings. Delegations have exchanged views, asked questions, sought clarifications and provided replies, clarifications, and information on the waiver request. On 21 May 2021, the co-sponsors issued a revised proposal which was circulated in document IP/C/W/669/Rev.1 and on 29 September 2021 they circulated a summary of their interventions in document IP/C/W/684.

“In the course of discussions on the revised waiver proposal, delegations have held focused discussions on the topics of scope, both from the perspective of products and of IP rights, on duration, implementation and the protection of undisclosed information.

“All 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, but discussions have shown that 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.

“EU proposal

“In addition, a proposal (IP/C/W/681) for a draft General Council declaration on the TRIPS Agreement and Public Health in the circumstances of a pandemic, issued by the European Union, has also been discussed in meetings since its circulation on 21 June 2021.

“The European Union proposal, which is backed by other developed country members, calls for limiting export restrictions, supporting the expansion of production, and facilitating the use of current compulsory licensing provisions in the TRIPS Agreement, particularly by clarifying that the requirement to negotiate with the right holder of the vaccine patent does not apply in urgent situations such as a pandemic, among other issues.

“While recognizing that intellectual property rights (IPRs) should not stand in the way of deploying and creating capacity, or of ensuring equitable access to vaccines and therapeutics, several developed and developing members have cautioned that this can be attained while maintaining IP as the basis for incentivizing investment in innovation, and for licensing technology transfer, so that members can effectively fight new strains of COVID-19 and any future diseases and pandemics. Some are particularly concerned that waiving IP rights might undermine the existing efforts and arrangements for large scale production of vaccines that rely, in part, on the IP system.  

“State of play

“Since the General Council held on 7 October 2021,  members have held intense contacts in various configurations. Some members have noted encouraging exchanges at small group discussions and bilateral meetings which have helped to identify points of convergence on how to provide a common IP response to COVID-19. Others have said that further conversations that move the TRIPS Council towards evidence-based and pragmatic solutions should guide their discussions at this critical juncture.

“At a meeting of the TRIPS Council on 18 November, members formally adopted an oral status report for the General Council on 22-23 November indicating that the TRIPS Council has not yet completed its consideration of the revised waiver request. The TRIPS Council will therefore continue its consideration, including through small-group consultations and informal open-ended meetings, and report back to the 12th Ministerial Conference (MC12) 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.

“This means the TRIPS Council remains in session so that it  can continue to provide a forum for delegations to provide transparency on their ongoing talks, and to adopt any elements or solutions they may have found.”

Despite the postponement of the 12th Ministerial Conference due to the increase in COVID cases from the omicron variant, WTO Members have indicated a desire to push ahead to resolve some matters, including the multilateral response to the pandemic. Last month, Director-General Ngozi Okonjo-Iweala urged WTO Members to push forward and seek a resolution on the WTO’s response to the pandemic by the end of February this year. See WTO press release, Members discuss way forward in dedicated meeting on WTO pandemic response, 27 January 2022,https://www.wto.org/english/news_e/news22_e/gc_27jan22_e.htm (“WTO members met on 27 January to discuss the WTO response to the COVID-19 pandemic. The informal meeting convened by the Chair of the General Council, Ambassador Dacio Castillo of Honduras, looked at issues related to cross-border trade flows and the proposal to waive certain intellectual property protections related to COVID-19 countermeasures. Director-General Ngozi Okonjo-Iweala called on members to move swiftly to try and reach a comprehensive outcome by the end of February.).

One week later according to press reports, Amb. Castillo called for a “strategic pause” in the formal negotiations on a WTO response to permit WTO Members to discuss their differences with each other outside of the full group format. See Inside U.S. Trade’s World Trade Online, General Council chair: WTO pandemic package talks need ‘strategic pause’, February 4, 2022, https://insidetrade.com/daily-news/general-council-chair-wto-pandemic-package-talks-need-%E2%80%98strategic-pause%E2%80%99.

Observations

The chances of a final resolution on a pandemic response package by the end of February seem remote if not nonexistent at the present time. The United States is reportedly not actively engaged and has raised some concerns with the export restraint portion of the package. There seems little likelihood that the EU and others supporting an approach other than TRIPS waiver will agree to a waiver, while those supporting a waiver don’t seem inclined to accept an alternative approach.

There are a number of reasons why a waiver is unlikely to be accepted. First, vaccine equity in 2021 had more to do with India’s failure to export the volumes of vaccines contracted with COVAX than any other single cause although slowness in shifting supplies from countries with surplus product was also an issue. In 2022, there will be sufficient supplies of vaccines for the entire world, and there have been major commitments by major countries to supply large volumes of doses to countries in need. UNICEF tracks capacity to produce COVID vaccines and shipments of vaccines. Around 11 billion doses were shipped globally (including in-country) in 2021 and projections for shipments in 2022 range from 16.8-20.9 billion doses. See COVID-19 Vaccine Market Dashboard, 5 February 2022, doses delivered collectively, 11.771 billion, https://www.unicef.org/supply/covid-19-vaccine-market-dashboard; forecasted COVID-19 vaccine supply availability, 2022 (low estimate 16.8 billion doses; base estimate, 18.7 billion doses; high estimate 20.9 billion doses) (under capacity tab), A waiver of TRIPS obligations would be unlikely to change the quantity of vaccines available for shipment in 2022, so seems unnecessary to address vaccinating the world’s population in 2022.

Second, multilateral efforts and efforts of some pharmaceutical companies has resulted in a rapid expansion of production capacity around the world as the above figures confirm. Even where pharmaceutical companies have not licensed their vaccine technologies, there have been independent breakthroughs including on mRNA vaccines. See, e.g., Reuters, In world first, South Africa’s Afrigen makes mRNA COVID vaccine using Moderna data, February 4, 2022, https://www.reuters.com/world/africa/world-first-safricas-afrigen-makes-mrna-covid-vaccine-using-moderna-data-2022-02-03/ (“CAPE TOWN, Feb 3 (Reuters) – South Africa’s Afrigen Biologics has used the publicly available sequence of Moderna Inc’s (MRNA.O) mRNA COVID-19 vaccine to make its own version of the shot, which could be tested in humans before the end of this year, Afrigen’s top executive said on Thursday. The vaccine candidate would be the first to be made based on a widely used vaccine without the assistance and approval of the developer. It is also the first mRNA vaccine designed, developed and produced at lab scale on the African continent.”).

Third, recent press articles indicate that some countries with very low vaccination rates have nonetheless developed significant antibodies in their populations due to prior waves of infections of COVID-19. With lower average age of populations, COVID-19 has had less severe consequences on their populations, such that there is a belief they are moving to an endemic situation with COVID-19. See my recent post, January 30, 2022:  Recent National Public Radio story, “Africa may have reached the pandemic’s holy grail,” raises interesting questions on a country’s age distribution and ability to get past the pandemic stage with lower vaccination rates, https://currentthoughtsontrade.com/2022/01/30/recent-national-public-radio-story-africa-may-have-reached-the-pandemics-holy-grail-raises-interesting-questions-on-a-countrys-age-distribution-and-ability-to-get-past-the-pandemic-stage-wit/.

All of the above suggests that the case for a waiver, at least at this time, is not strong, which will likely keep opposition of the EU and others strong.

The WTO has served as a depository for information on the types of restrictions and has permitted Members to encourage limiting restrictions on access to critical medicines and inputs. It has also developed reports helpful to Members to understand existing barriers or restrictions as well as to do outreach to the private sector for a better understanding of bottlenecks in production and distribution ramp-ups. The WTO in conjunction with other multilateral organizations has helped generate information to better inform the needs of countries for assistance and develop more coordinated efforts at support.

The WTO Members may yet be able to reach agreement on a response to the pandemic that will not only help with the current pandemic but establish a common frame of reference of dealing with future pandemics in a more effective manner that promotes greater equity. It is just unlikely to happen in the next 23 days.

WTO efforts to address the COVID-19 pandemic — the January 10, 2022 General Council meeting and some current developments of interest

As the world enters the third full year of fighting the COVID-19 pandemic, the WTO continues to seek both a response to the current challenges and a path forward for future pandemics. India, which along with South Africa (and later support from other countries), has sought since October 2020 a waiver from certain intellectual property protections provided under the WTO’s Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) to address the COVID-19 pandemic, in late December 2021 sent a letter to the General Council Chair of the WTO seeking a virtual ministerial meeting to address the WTO response to the pandemic. This followed the postponement of the 12th WTO Ministerial Conference because of restrictions on travel flowing from the increase in COVID cases from the omicron variant.

The WTO press release on the General Council informal meeting held on January 10, 2022 to explore India’s request put a largely positive spin on the meeting, although press accounts suggest that there was push back from many other WTO Members to holding such a virtual Ministerial for various reasons, including lack of progress in developing an agreed text on any TRIPS waiver, need to address other pressing issues and the challenges of doing a Ministerial meeting virtually based on last year’s experience. See WTO news release, General Council discusses India’s call for virtual ministerial meeting on pandemic response, 10 January 2022, https://www.wto.org/english/news_e/news22_e/gc_10jan22_e.htm (” General Council Chair Ambassador Dacio Castillo (Honduras) convened the 10 January meeting in response to India’s recent proposal to hold a virtual Ministerial Conference on the WTO’s response to the COVID-19 pandemic, including a proposed waiver of relevant intellectual property protections. At the meeting, Director-General Ngozi Okonjo-Iweala urged WTO members to urgently step up their efforts, suggesting that with the requisite political will, members can in the space of the coming weeks reach multilateral compromises on intellectual property and other issues so that the WTO fully contributes to the global response to COVID-19 and future pandemics.”); Inside U.S. Trade’s World Trade Online, WTO members reluctant to hold virtual ministerial on TRIPS waiver, January 10, 2022, https://insidetrade.com/daily-news/wto-members-reluctant-hold-virtual-ministerial-trips-waiver (“India’s bid to schedule a virtual ministerial meeting focused on the proposed waiver of some intellectual property obligations to fight the pandemic did not win the support of other World Trade Organization members on Monday, as they raised concerns about the virtual format as well as with a lack of progress in the negotiations.”). While the U.S. was reportedly favorably disposed to such a meeting with greater clarifications, the European Union statement noted all of the issues raised in the Inside U.S. Trade article. See also The Hindu, WTO General Council discusses India’s call for holding virtual Ministerial meet on COVID-19 pandemic response, 11 January 2022, https://www.thehindu.com/business/wto-general-council-discusses-indias-call-for-holding-virtual-ministerial-meet-on-covid-19-pandemic-response/article38231454.ece.

While the U.S., under the Biden Administration, has stopped posting on the U.S. Mission website their statements at meetings other than the Dispute Settlement Body (unclear if this is due to a policy change or simply the lack of a Deputy USTR confirmed by the Senate), the EU is posting their statements on their Geneva website. See EU Statement at the General Council Informal Meeting, 10 January 2022, https://eeas.europa.eu/delegations/world-trade-organization-wto/109489/eu-statement-general-council-informal-meeting-10-january-2022_en. The entirety of the EU statement is copied below.

“Statement delivered by Ambassador João Aguiar Machado

“For the European Union, the WTO needs to put in place a process that is conducive to progress on all topics of the MC12 agenda.

“Of course, the European Union shares the view that the response to the pandemic is important. However, we need to be careful that a focus on this part of the MC12 agenda must not lead to a loss of momentum on the other key components, which are equally essential to the revitalisation of the organisation – such as the conclusion of the fisheries subsidies negotiations, agreeing on a way forward on agriculture, and finalising the Ministerial Declaration with a strong commitment on WTO reform – and this, building upon the work done by you, Chairman [Chairman of the General Council], in the run-up to the Ministerial meeting in November. These elements are all essential for the credibility and viability of this organisation. WTO reform is also essential from a health perspective. We need an efficient and effective organisation if we are going to be in a position to act decisively in the case of future pandemics.

“Before any decision to call a virtual Ministerial meeting and topics to be decided, we believe the WTO Director General and the Chair of the General Council should hold consultations with Members, to assess the way forward on all four issues that I referred to.

“As regards trade and health, the aim should be to seek consensus on the way forward both on intellectual property and on the Declaration and Action Plan. As regards the latter, Ambassador Walker’s draft text should be the basis for such consultations. And as regards intellectual property rights, consultations should continue with a view to identifying a text on which the WTO Membership can agree.

“Any virtual Ministerial should take place only once there is a consensus both on intellectual property rights and on the Declaration and Action Plan on the wider pandemic response. Only a comprehensive trade response to the pandemic can make a difference and address the identified bottlenecks as regards the production and distribution of COVID-19 vaccines such as restricted access to raw materials and other inputs as well as complex supply chains. Agreeing on the comprehensive elements contained in the Walker text will be important not only to tackle Covid-19, but also to address future pandemics.

“If we want to take forward work on all elements of the MC12 agenda, we must have a credible process in place.

“In summary, the European Union is open to consider the proposal by India and to reach an agreement on all aspects of the response to Covid-19 as quickly as possible. However, in the European Union’s view, it is premature to decide at this point in time on either the principle or on the date for such a virtual meeting.”

Thus, while the Director-General is pushing Members for an early resolution of the pandemic response (including any TRIPS waiver), the path forward looks certain to take significantly more time than a few weeks to reach agreement.

The WTO has added a page to its website entitled “Trade and health: WTO response to the COVID-19 pandemic”. The page accessed today states “State of Play – 6 January 2022” — i.e., before the informal General Council meeting on January 10th. However, it provides a good overview of what has been proposed and differences that exist on the waiver issue. See Briefing Note, State of Play 6 January 2022, Trade and health: WTO response to the COVID-19 pandemic, https://www.wto.org/english/thewto_e/minist_e/mc12_e/briefing_notes_e/bftrade_and_health_e.htm. The briefing note is embedded below.

WTO-_-Ministerial-conferences-MC12-briefing-note

Some current developments of interest

By the end of 2021, COVID vaccines were being produced at a rate of about 1.5 billion doses per month. Additional vaccines are being added which will drive production up even higher during the early months of 2022. See, e.g., BBC, Covovax and Corbevax: What we know about India’s new Covid vaccines, 28 December 2021, https://www.bbc.com/news/world-asia-india-55748124.

Corbevax has received a lot of attention in the media in the last few weeks. The Indian producer has 150 million doses ready for distribution, will be producing 100 million doses per month and plans to export one billion doses to other countries. The developers and the Indian producer are working with the WHO to pursue emergency use authorization through the WHO as well. See, e.g., NPR, A Texas team comes up with a COVID vaccine that could be a global game changer, January 5, 2022, https://www.npr.org/sections/goatsandsoda/2022/01/05/1070046189/a-texas-team-comes-up-with-a-covid-vaccine-that-could-be-a-global-game-changer (“A vaccine authorized in December for use in India may help solve one of the most vexing problems in global public health: How to supply lower-income countries with a COVID-19 vaccine that is safe, effective and affordable. The vaccine is called CORBEVAX. It uses old but proven vaccine technology and can be manufactured far more easily than most, if not all, of the COVID-19 vaccines in use today. ‘CORBEVAX is a game changer,’ says Dr. Keith Martin, executive director of the Consortium of Universities for Global Health in Washington, D.C. ‘It’s going to enable countries around the world, particularly low-income countries, to be able to produce these vaccines and distribute them in a way that’s going to be affordable, effective and safe.'” “Hotez says that unlike the mRNA vaccines from Pfizer and Moderna, and the viral vector vaccine from Johnson & Johnson, protein subunit vaccines like CORBEVAX have a track record. So he and Bottazzi were relatively certain CORBEVAX would be safe and effective. ‘And it’s cheap, a dollar, dollar fifty a dose,’ Hotez says. ‘You’re not going to get less expensive than that.'”); The Times of India, Discussions underway for WHO approval for
Corbevax Covid-19 vaccine, says developer, 31 December 2021, https://timesofindia.indiatimes.com/world/us/discussions-underway-for-who-approval-for-corbevax-covid-19-vaccine-says-developer/articleshow/88604880.cms.

These developments are occurring at a time of record breaking numbers of new infections due to the more highly contagious omicron variant. While many parts of the world are seeing huge surges, Europe and the United States are seeing particularly huge increases. See, e.g., Reuters, U.S. reports 1.35 million COVID-19 cases in a day, shattering global record, January 11, 2022, https://www.reuters.com/business/healthcare-pharmaceuticals/us-reports-least-11-mln-covid-cases-day-shattering-global-record-2022-01-11/; WHO, WHO: 7 million new omicron COVID cases in Europe last week, January 11, 2022, https://www.washingtonpost.com/politics/who-7-million-new-omicron-covid-cases-in-europe-last-week/2022/01/11/7e901e28-72cc-11ec-a26d-1c21c16b1c93_story.html.

A few thoughts

When one looks at vaccination distribution in 2021, the concerns about inequity center largely on the vary small volume of vaccines that have gone to low income countries (as classified by the World Bank) and to some lower middle-income countries. See, e.g., December 30, 2021:  COVID-19 and vaccine equity — outlook for 2022, https://currentthoughtsontrade.com/2021/12/30/covid-19-and-vaccine-equity-outlook-for-2022/.

The largest volume of vaccines that COVAX had envisioned going to these countries were lower cost ones that would be easier to store, handle and administer than some of the high cost new technology vaccines. Production problems and export bans of the more cost effective and easier to store vaccines in 2021 were the largest reasons of poor distribution of vaccines to lower income countries.

With large volumes of donations committed for 2022 from countries like the U.S. and EU and others and with Indian production both ramping up significantly and exports having resumed and with the availability of low cost options, including new vaccines like Corbevax already approved in India and likely to be produced in various countries around the world at very low costs, and with the overall very high levels of global vaccine production by the end of 2021 continuing to expand, the question of getting the world vaccinated in 2022 against COVID will almost certainly be more about issues other than availability of vaccines.

So the WTO’s most important role in the coming weeks and months is to focus on reducing barriers to trade such as those covered by the Walker draft text (discussed in the briefing paper). The TRIPS waiver issue is one that has attracted a lot of attention because of the perception of global needs and whether intellectual property rights were restricting access. In my view, while the proposal was popular with many groups, the evidence of production during 2021 did not support the concern that the TRIPS agreement was restricting production. More than 10 billion doses of COVID-19 vaccines were produced and shipped in 2021 — twice as many doses as all vaccines produced and shipped in 2020 for all other needs. Many licenses were granted for production in other countries. A waiver would not have resulted in significantly more production in 2021.

Production in 2022 and the arrival of new low cost vaccines should mean there is adequate volumes for the world to achieve 70% vaccination rates this year. The issue of equity in 2021 had to do with distribution of the production, infrastructure in many countries, trade restrictions on vaccines and inputs. These do not require a TRIPS waiver to address in 2022.

Looking forward to the next pandemic, there is much that the WTO Members could agree to that would reduce many of the challenges COVID-19 has posed. It is not clear that actions on intellectual property beyond what is being proposed by the EU are needed or justified by the experience gained these last several years.