Symposium | Building Resilience: Advancing Local R&D and Production of Health Products in the WHO Pandemic Agreement
Building Resilience:
Advancing Local R&D and Production of Health Products in the WHO Pandemic Agreement
Introduction to the Symposium
By Ayelet Berman
Published on 11 November 2024
“Give a man a fish, and you feed him for a day;
teach a man to fish and you feed him for a lifetime.”
Background: The COVID-19 Pandemic
The COVID-19 pandemic revealed gaps in global vaccine access. Most of the vaccine research and development (R&D) and production was concentrated in just a few companies and countries in the Global North. Furthermore, high-income countries quickly secured bilateral agreements for vaccine doses, whereas low- and middle-income countries (LMICs) faced severe shortages. The current Mpox outbreak is dealing with a similar problem: while vaccines have already been developed and are available, most are held in Western stockpiles, and countries in Africa that need the vaccine the most don’t have enough. Thus, a key issue with infectious disease outbreaks is: how do we improve equitable access to vaccines in LMICs?
During the pandemic, a variety of initiatives were launched to improve equitable vaccine access in LMICs. These included the establishment of COVID-19 Vaccines Global Access (COVAX), an international initiative whose purpose was to procure COVID-19 vaccines for LMICs. There were also proposals at the World Trade Organization (WTO) to adopt a waiver to the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS waiver), such that LMICs could “copy” patented vaccines and manufacture generic versions locally. Ultimately, because of limited worldwide supply, COVAX ended up competing and losing to high-income countries that purchased most of the supplies for their populations. Further, the TRIPS waiver was only adopted in 2022, and it was limited to vaccines and did not cover other health products such as therapeutics and diagnostics. Irrespectively, in contrast to therapeutics, which are chemical compounds (and hence easier to “copy”), manufacturing vaccines is a complicated process, and many LMICs lack the necessary technologies, know-how, or facilities. Thus, even had a waiver been granted earlier, many countries would still not be able to produce vaccines. Overall, while many actors scrambled to come up with an equitable response, the outcome was one of a significant divide between high- and low-income countries.
Negotiations on a Pandemic Agreement
Following the pandemic, consensus emerged that the existing international legal framework (the International Health Regulations) was not fit for purpose. Thus, in December 2021, member states of the World Health Organization (WHO) established an International Negotiations Body (INB) and embarked on negotiations for a ‘WHO Convention, Agreement, or Other International Instrument on Pandemic Prevention, Preparedness, and Response.’ Considering the lessons learned from the COVID-19 pandemic, equitable access of individuals and countries to pandemic-related health products (diagnostics, therapeutics, vaccines and other products – see proposed Article 1(d)) during a pandemic has become a central pillar of the pandemic agreement negotiations. “Equity” is one of the guiding principles of the agreement (Article 3(4)) and is operationalized in many proposed provisions and obligations.
One of the most important takeaways from the pandemic has been that to advance equitable access to pandemic-related health goods, addressing intellectual property barriers is insufficient. As mentioned above, without the necessary facilities, capacities and technologies, countries are unable to produce vaccines, even when IP protections are waived. Thus, LMICs should become more self-sufficient through the development of local or regional R&D and production capacity with respect to pandemic-related health products.
Against this backdrop, the Pandemic Accord has added several provisions whose objective is to enhance local or regional capacity. This symposium focuses on the three provisions which address R&D, local production and technology and know-how transfer:
- Article 9 on “Research and Development”
- Article 10 on “Sustainable and geographically diversified local production.”
- Article 11 on “Transfer of technology and know-how for the production of pandemic-related health products”
These three clauses are unprecedented in global health security law. So far, there has not been an international agreement on these topics. The International Health Regulations (IHR)—the only international treaty (so far) governing public health emergencies and pandemics—is a functional/technical instrument that aims to contain the international spread of disease, but it has historically not governed access to health goods. While member states agreed at the 77th World Health Assembly in June 2024 to amend the IHR and require the WHO to facilitate equitable access to health products, the IHR does not govern other aspects of equitable access to health goods. In this regard, the pandemic agreement introduces a new approach. It aims to advance equitable access to pandemic-related health goods by strengthening R&D and manufacturing capacity in LMICs, and in turn, developing local self-sufficiency. Thereby, the pandemic accord arguably seeks to operationalize the wisdom of the well-known ancient proverb: ‘Give a man a fish, and you feed him for a day; teach a man to fish and you feed him for a lifetime.’
The draft pandemic agreement also introduces “solidarity” under Article 3(5) as a new guiding principle, thus expecting developed countries to support better pandemic preparedness, prevention, and response in LMICs. In this vein, the draft provisions in Articles 9–11 require or encourage (the strength of the language is currently under negotiation) developed countries to support LMICs in their development of local R&D and production capacity.
Reaching agreement on the scope of these obligations and the extent of their obligatory nature has been difficult, and the negotiations of the INB have been extended. While originally set for the 77th World Health Assembly in May–June 2024, the deadline has been shifted to the 78th World Health Assembly in May 2025.
This Symposium
Against this background, we have invited four leading global health law scholars to provide short contributions on these (draft) provisions: Pedro Villarreal, Nicole Foster, Ronald Tundang and Kashish Aneja. We hope that these short contributions will provide useful insights to our understanding of the legal complexities of this topic.
They presented their preliminary comments at the “The World Together in Pandemic Preparedness and Response” a side-event at the Global Health Security Conference in Sydney on 17 June 2024, which was co-organized by CIL, the Asia Centre for Health Security, and others. They have now written them up for this symposium. Their comments are with respect to the latest draft, as published on 27 May 2024, and with respect to negotiations progress as of 19 September 2024.
Pedro Villarreal argues that R&D (Article 9) is crucial for pandemic response, but that the treaty should provide further guidance on grant funding contracts and procurement contracts, as these are pivotal moments that have a significant impact on equitable access. Governments could promote equitable access in LMICs by incorporating equitable access conditions (such as price caps or voluntary licensing requirements) in funding contracts. He also highlights the often-overlooked significance of basic research for pandemic response. While Pedro’s’ call to include such provisions would promote equitable access, this issue is difficult to agree on. Some governments are concerned about interference with their private contracting powers, or with the fact that they provide more R&D funding than others, which would result in unequal burden sharing.
Nicole Foster argues that, while the goal of encouraging local production and resilience is remarkable (Article 10) as it would lessen the dependence of developing countries on supplies from high-income countries, putting it into action will be extremely difficult. Developing local self-sufficiency is dependent on voluntary licensing, technology transfer, investments, and more—matters that are highly contentious and difficult to achieve. She then provides examples of several independent regional initiatives in Africa and the Caribbean that plan to manufacture 60% of essential pharmaceuticals and vaccines by 2040. Nicole’s contribution demonstrates that, even in the absence of a pandemic agreement, governments and regions have pathways for strengthening local capability.
Ronald Tundang presents a compelling case that to increase local capacity, countries must implement industrial policies. Yet many such policies are or could be in violation of the state’s free trade agreements or bilateral investment treaties, exposing them to potential legal disputes. Thus, rather than just including relevant provisions in a pandemic agreement, international trade and investment rules must be amended to permit specific types of pandemic-related activities. His argument reflects a crucial point that the global health law community should keep in mind: other areas of law, including international trade, investment and intellectual property, must be examined to enhance LMICs self-sufficiency.
Finally, Kashish Aneja contends that, while Article 11 on Technology Transfer is a significant step towards developing equal access to medical countermeasures, the proposed provisions’ voluntary nature is insufficient to affect genuine change. Thus, stronger and more enforceable measures are required if real change is to be achieved. Kashish’s points reflect the difficulty of concluding a multilateral agreement involving and affecting so many distinct stakeholders with different and sometimes competing interests. Softening the language is often the only way to achieve consensus, but this comes at the expense of an agreement’s binding force.
In Sum
To summarize, developing local or regional self-sufficiency in pandemic-related health products is critical for providing rapid access to health products during health emergencies. The inclusion of such provisions in the pandemic agreement is new and is commended. Furthermore, it reflects a growing understating that the law plays an important role in facilitating or impeding local public health capacity.
However, as reflected in the short contributions, there are many legal and political complexities in developing local self-sufficiency. Many of the issues being negotiated are also divisive, reflecting tensions between commercial and public health interests, as well as between the global north and south. Thus, getting to a meaningful international agreement in a short period of time is difficult. We hope these contributions have managed to shed some light on these complexities and on current developments.
Dr. Ayelet Berman is the Lead for the Global Health Law Program at the Centre for International Law, and the Law and Governance Program, Asia Centre for Health Security. She is a Visiting Associate Professor at the Saw Swee Hock School of Public Health, National University of Singapore.
Thanks to Ms. Kriti Sharma (Research Associate at the Centre for International Law) for her assistance in organizing this symposium.
The Global Health Security Conference in Sydney was a panel that was co-organized/co-funded by the Centre for International Law, the Asia Centre for Health Security, and others.
