Multilateral Matters
An occasional blog on International developments related to intellectual property, innovation, development and public policy.
Preface by Adjunct Professor Wend Wendland
An important and fascinating multilateral negotiation is underway at the World Health Organization (WHO) in Geneva aimed at agreeing on a new convention, agreement or other international instrument on pandemic prevention, preparedness and response. There are critical policy issues at stake. In addition, the process itself – from a methodological point of view – is interesting too.
Victor Owade has been following the process since its inception, and so I invited him to prepare a succinct description of the work completed so far. His report is current as of October 2023. Subsequent blogs will brief on what occurs after.
Over to you Victor!
Key takeaways
- Governments have set in motion an intergovernmental process to negotiate an international legal instrument on pandemic prevention, preparedness, and response by May 2024.
- The fundamental challenge will be to ensure that equity is achieved and that actions taken will be coordinated in a timely and efficient manner for the benefit of all countries.
- It is still not clear what role intellectual property (IP) will eventually play in a future pandemic treaty.
Introduction
The COVID-19 pandemic has undoubtedly exposed significant gaps in the global health architecture’s ability to deliver effective pandemic responses that leave no country or person behind. This is despite the fact that safe and effective vaccines were developed and approved in a record 12 months – the fastest in human history.[i] It was indeed the case that the majority of the world’s population living in poor and developing countries faced enormous challenges trying to secure vaccines on a fair and equitable basis even though sufficient doses were produced.[ii] The evidence clearly shows that while three in four people from high-income countries received at least one vaccine dose, only one in four did so from low and middle-income countries.[iii]
Accordingly, there is a strong rationale for governments to create a pandemic preparedness and response framework that can begin to address some of these challenges and avoid similar occurrences in the future where some felt like “beggars” when they most needed access to vaccines and related products.[iv] Many would agree that a global pandemic accord therefore represents a once-in-a-generation opportunity to protect humanity based on principles of solidarity and cooperation rather than isolationism and nationalism.[v] Simply put, all countries, communities, and people must have access to vaccines and pandemic related products in a timely, sustainable, and equitable manner as a matter of course.[vi]
A pandemic accord
Calls for a new international instrument to regulate global pandemic preparedness and response were first mooted in March 2021 by over 20 world leaders during the height of the COVID-19 pandemic. [vii] According to that call:
The main goal of this treaty would be to foster an all-of-government and all-of-society approach, strengthening national, regional and global capacities and resilience to future pandemics. This includes greatly enhancing international cooperation to improve, for example, alert systems, data-sharing, research, and local, regional and global production and distribution of medical and public health counter measures, such as vaccines, medicines, diagnostics and personal protective equipment.
Governments heeded this plea and in December 2021 and took the historic decision at the World Health Organization (WHO) to establish an Intergovernmental Negotiating Body (INB) to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response (pandemic instrument).[viii] The ambitious expectation is that such an instrument would be legally binding and, in principle, be concluded by May 2024 at the 77th World Health Assembly (WHA).[ix]
In terms of the process, the INB has so far held 6 meetings that have mostly focused on building consensus and a shared understanding of the issues between Member States. It is expected that the INB will hold 3 more meetings between November 2023 and March 2024 that will finalize and agree on a text for adoption by the WHA.[x] While some reservations have been expressed about this ambitious timeline[xi] and the seemingly slow pace of negotiations,[xii] failure is not an option as the stakes are too simply too high.[xiii]
In so far as the instrument itself is concerned, the INB Bureau in June 2023 prepared a compilation text for the consideration of governments[xiv] that synthesises all inputs received from Member States.[xv] It proposes 41 draft articles, including several options under various themes that Member States must work to find a common agreement. The compilation text will help to facilitate the work of the INB Drafting Group to produce a formal negotiating text by October 2023 that would eventually drive the process forward.[xvi]
The INB Bureau’s compilation is not an official text per se and there is a clear understanding among Member States that nothing is agreed until everything is agreed.[xvii] In diplomatic terms, this means that countries reserve the right to introduce new proposals or language at any time which could further complicate the challenging task at hand. It is therefore the INB Bureau’s duty to ensure that all views and concerns are taken on board throughout the formal and informal sessions of the INB while at the same time giving the necessary confidence to Member States to begin actual textual negotiations.[xviii]
Issues at stake
Process aside, one of the fundamental and recurring themes which the pandemic instrument must address relates to the important question of equity. Equity is the central focus of Chapter II of the Bureau’s compilation text with 16 draft articles that seek to frame how governments will ensure equity in essential areas such as, for instance, research and development (art 9), technology development and transfer (art 11), as well as access and benefit sharing (art 12). Equity is also addressed in Chapter I of the compilation text as part of the pandemic instrument’s overall objective (art 2) and general principles (art 3 (3)).
From an intellectual property (IP) perspective, some initial observations can be made with regard to some of the proposals on the table for consideration.
Intellectual property issues
First, the draft provisions on R&D (art 9) seem to focus almost entirely on open access approaches as regards the outputs of publicly funded research for pandemic-related products. This is understandable given that COVID-19 vaccines benefited immensely from public funding[xix], yet access for many developing countries was a challenge. The pandemic accord therefore seeks to address how to facilitate and allow for the rapid dissemination of pandemic-related information, especially for the benefit of developing countries. One way it proposes to do this is by having strong obligations around publishing and enabling access to clinical trial data based on open science and open-source approaches. The draft provisions on R&D, however, fail to address the incentive structure that will be required to realise this goal. Additionally, there is also uncertainty about the extent to which some of the mechanisms and principles permitted by the IP system in relation to fair or permitted uses and exceptions and limitations to IP rights could eventually complement such an effort.
Second, as regards technology development and transfer (art 11), the compilation text provides options for strengthening and developing mechanisms to promote the pooling of IP and data in order to enhance the production of pandemic-related products on mutually agreed terms. There are also suggestions to incentivize favourable licenses to developing countries for pandemic-related products that receive significant public financing during pandemics as well as obligations to take appropriate measures to support time-bound waivers of IP rights that can accelerate or scale up the manufacturing of pandemic-related products. In addition, there is also a strong emphasis in the compilation text on applying the full use of flexibilities available under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and, most notably, placing obligations on patent holders of pandemic-related products to allow developing country manufacturers to use protected technologies on a royalty free basis, especially if they received public financing during their development.
Third, on access and benefit-sharing (art 12), there are proposals to establish a system for access and benefit-sharing of biological materials with epidemic and pandemic potential during pandemics with the notable caveat that such a system should be consistent with existing international instruments–most notably the Convention on Biological Diversity (CBD) and the Nagoya Protocol. Interestingly, the details of such a system are expected to be worked out at a later stage which gives rise to related concerns about the interoperability and applicability of such a system in a mutually supportive manner.
Implications for the intellectual property system
All of these proposals will certainly give rise to questions (and concerns) about the role of the IP system in relation to equity and access. It is therefore important to bear in mind that under the institutional arrangements heading (Chapter III), art 27 of the INB’s compilation text in this regard includes an important provision about the relationship between the pandemic instrument and other international treaties. Significantly, it states that the pandemic instrument “shall not affect the rights and obligations of any Party under other existing international instruments and shall respect the competencies of other organizations and treaty bodies”.[xx]
Given the importance of TRIPS in harmonising substantive international rules concerning the availability, scope, use, and enforcement of IP rights, it will be vital to see how the relationship between TRIPS (as well other IP treaties) which implicate pandemic-related protectable subject and the pandemic accord are eventually reconciled in the final text, and what role international institutions will play in this regard.
Whatever the outcome, it is not in doubt that IP rules and norms ought not to be seen or perceived to contradict the aims of a pandemic accord. A safer world from pandemics is a shared goal for all of humanity. The careful balance which the TRIPS Agreement strikes to ensure that the protection and enforcement of IP rights indeed incentivises the production and manufacture of pandemic-related products while at the same time safeguarding user and public interests in having access to these products should inform consideration and debate about the role of IP in the pandemic accord. Arguably, a strong and progressive pandemic accord must carefully reflect and balance these same interests to ensure that the world can overcome pandemics working in tandem rather than in silos.
What remains to be seen is exactly whether and how this will be done.
This blog is written in the author’s personal capacity and does not represent the view of any organization or institution. This blog was written in October 2023.
[i] S. Cohen, “The fastest vaccine in history” (UCLA Health, 20 December 2020), https://connect.uclahealth.org/2020/12/10/the-fastest-vaccine-in-history/ [Accessed 14 August 2023].
[ii] International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), “11 billion COVID-19 vaccines produced in 2021 has resulted in the biggest immunization campaign in human history and 2022 will require more and better vaccine redistribution and innovation” (16 December 2021), https://www.ifpma.org/resource-centre/11-billion-COVID-19-vaccines-produced-in-2021-has-resulted-in-the-biggest-immunization -campaign-in-human-history-and-2022-will-require-more-and-better-vaccine-redistribution-and-innovation/ [Accessed 2 September 2023].
[iii] “Coronavirus (COVID-19) Vaccinations” (Our World in Data, 2 August 2023), https://ourworldindata.org/covid-vaccinations [Accessed 4 September 2023].
[iv] “Cyril Ramaphosa lays into the West in Paris for vaccine inequality” (Business Daily, 26 June 2023), https://www.businesslive.co.za/bd/national/2023-06-26-cyril-ramaphosa-lays-into-the-west-in-paris-for-vaccine-inequality/ [Accessed 4 September 2023].
[v] “COVID-19 shows why united action is needed for more robust international health architecture”, WHO, 30 March 2021, https://www.who.int/news-room/commentaries/detail/op-ed—covid-19-shows-why-united-action-is-needed-for-more-robust-international-health-architecture [Accessed 21 September 2023].
[vi] “Adopting Landmark Declaration, General Assembly Calls for Strengthening High-level International Coordination to Improve Pandemic Prevention, Preparedness, Response”, UN, 20 September 2023, https://press.un.org/en/2023/ga12533.doc.htm [Accessed 23 September 2023].
[vii] “COVID-19 shows why united action is needed for more robust international health architecture”, WHO, 30 March 2021, https://www.who.int/news-room/commentaries/detail/op-ed—covid-19-shows-why-united-action-is-needed-for-more-robust-international-health-architecture [Accessed 21 September 2023].
[viii] See “World Health Assembly agrees to launch process to develop historic global accord on pandemic prevention, preparedness and response”, WHO, 1 December 2021, https://www.who.int/news/item/01-12-2021-world-health-assembly-agrees-to-launch-process-to-develop-historic-global-accord-on-pandemic-prevention-preparedness-and-response [Accessed 4 September 2023].
[ix] “Pandemic instrument should be legally binding, INB meeting concludes”, WHO, 21 July 2021, https://www.who.int/news/item/21-07-2022-pandemic-instrument-should-be-legally-binding–inb-meeting-concludes [Accessed 27 September 2023].
[x] See “INB Process”, WHO, 2023, https://inb.who.int/home/inb-process [Accessed 27 September 2023].
[xi] See “Some Countries May Push For More Time To Conclude Negotiations For The Pandemic Accord; First Draft Likely By Mid-October”, Geneva Health Files, 8 September 2023, https://genevahealthfiles.substack.com/p/some-countries-may-push-for-more [Accessed 29 September 2023].
[xii] See “As UN Pandemic Talks Resume, Tedros Expresses ‘Concern’ About Slow Pace of Accord Negotiations”, Health Policy Watch, 29 August 2023, https://healthpolicy-watch.news/as-un-pandemic-talks-resume-tedros-concern-about-slow-pace-of-accord-negotiations/ [Accessed 29 September 2023].
[xiii] “Adopting Landmark Declaration, General Assembly Calls for Strengthening High-level International Coordination to Improve Pandemic Prevention, Preparedness, Response”, UN, 20 September 2023, https://press.un.org/en/2023/ga12533.doc.htm [Accessed 30 September 2023].
[xiv] See “Bureau’s text of the WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response (WHO CA+)”, WHO, 2 June 2023, A/INB/5/6.
[xv] “Member States continue work on potential pandemic accord”, WHO, 25 July 2023, https://www.who.int/news/item/25-07-2023-member-states-continue-work-on-potential-pandemic-accord [Accessed 29 September 2023].
[xvi] “INB Bureau to develop a proposal for negotiating text of the pandemic accord” WHO, 13 September 2023, https://www.who.int/news/item/13-09-2023-inb-bureau-to-develop-a-proposal-for-negotiating-text-of-the-pandemic-accord [Accessed 29 September 2023].
[xvii] “Bureau’s text of the WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response (WHO CA+)”, at para 3.
[xviii] “Pandemic Accord Negotiations Inch Towards First Draft with Co-Chair Urging Substance Over Speed”, Health Policy Watch, 17 July 2023, https://healthpolicy-watch.news/pandemic-accord-negotiations-inch-towards-first-draft/ [Accessed September 29, 2023].
[xix] “COVID-19 Vaccine R&D Largely Public Money and Highly-Concentrated, New Data Resource Finds”, Graduate Institute, 30 March 2021, https://www.graduateinstitute.ch/vaccines-RD [Accessed 29 September 2023].
[xx] WHOCA+, art.27(2).