Symposium | Building Resilience: Advancing Local R&D and Production of Health Products in the WHO Pandemic Agreement
Research and Development in the Pandemic Agreement: Self-Limiting Treatymaking
By Pedro A. Villarreal
Published on 11 November 2024
The rapidness with which new vaccines were developed against COVID-19 is often touted as a success story of scientific discovery. What was usually a years-long research and development (hereinafter R&D) process to devise and test new vaccines was achieved in a months-long period. Individuals at the forefront of their development became world renowned. One of them, Katalin Karikó, even won the Nobel Prize in Medicine—albeit not for the vaccines per se, but rather for the discovery in 2005 of how modifying RNA could lead to an increase in the body’s immune response.
The story has another, much more unfortunate side to it. The COVID-19 pandemic was a stark display of global inequities in the distribution of the results of such R&D. Vaccine nationalism led to higher-income countries generally receiving vaccine doses much more promptly than lower-income ones. Meanwhile, companies that manufactured these new and effective vaccines against COVID-19 profited immensely. All of this resulted in what the World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus referred to as a “catastrophic moral failure”.
Facing these circumstances, the challenge for the proposed pandemic agreement at the WHO is, on the one hand, ensuring that states enable conditions for future successful R&D; while, on the other hand, ensuring that the results of such R&D are distributed equitably in the case of a pandemic. Against this backdrop, the following lines offer an assessment of the position R&D holds in the draft pandemic agreement, particularly in the current wording of Article 9.
Strengthening R&D Capacity and Cooperation
The draft pandemic agreement dedicates an entire provision – Article 9 – to R&D. At face value, it makes an attempt at advancing R&D capacity in developing countries, including improving international R&D cooperation. The current wording of Article 9(1) determines that ‘The Parties shall cooperate… to build, strengthen and sustain geographically diverse capacities and institutions for research and development, particularly in developing countries, and shall promote […] access to research.’ Article 9(4) states that ‘Each Party… shall support the transparent and public sharing of results.’
This is the first time that R&D has been included in an international treaty, which is a major development. Yet Article 9 in its current form is self-limiting and falls short of addressing issues that have a tangible, on-the-ground impact and would advance equitable access to the outcomes of R&D. I highlight two shortcomings: (1) grant conditions and (2) procurement.
Grant conditions
While Article 9(5) calls states to develop policies on public funding of R&D that foster equitable access to pandemic-related health goods resulting therefrom, the pandemic agreement itself does not detail the legal conditions upon which third-party financing for R&D, both public and private, should be granted. The agreement overlooks that inequities in the global distribution of medical goods against pandemic diseases are actually determined at the very initial R&D stages when the grant is given to innovators to pursue projects. Grantors determine the conditions upon which the grant will be exercised, and how the ownership of the end results will be regulated. Therefore, the grant contract is key for determining equal access conditions with respect to the outcome of the research.
During the COVID-19 pandemic, several companies received generous support from governments for conducting research. Though such financial support did not shoulder the entire cost of R&D, it did contribute to sharing the risk involved in the process, especially in case the resulting vaccine candidates were unsuccessful. Despite these circumstances, there were few or no conditionalities for the use of such funding, having ‘little to no strings attached.’ Thus, one of the key lessons learned from the COVID-19 pandemic is that equitable access conditions should be included in the grant. Future grant contracts could make the provision of funds dependent on the recipient agreeing to conditions that would advance equitable access (such as pricing of the product, distribution, voluntary licensing etc.). The fact that the current draft pandemic agreement ignores this problem is a major shortcoming and should be addressed in its future versions.
Procurement
The second decisive moment in access to pandemic-related health goods is the public procurement procedures conducted by governments to purchase goods for their populations. There is, as yet, no comprehensive study on whether, and to what extent, public investments by governments in R&D conducted by private actors resulted in any benefits in the pricing of the resulting health products. The pandemic agreement omits any obligation to change these practices, which other commentators have criticized as well.
In sum, the current draft does not address “hands-on” matters that would actually improve equitable distribution of R&D innovation. Moreover, while reforming national laws on public financing of R&D, and on public procurement procedures of pandemic-related products would be a massive undertaking, international negotiations should remain ambitious.
The Missing Piece: Strengthening the Broader Research Infrastructure
Another issue that has been ignored in the draft pandemic agreement concerns the relevance of basic research to pandemic response. Indeed, Article 9 of the pandemic agreement focuses on R&D aimed at pandemic prevention, preparedness and response. In its current version, Article 9(2)(a) requires states to invest in, and support ‘research institutions and networks that can rapidly respond to research and development needs in the event of a pandemic emergency,’ and for broader ‘public health priorities.’ Such priorities include the epidemiology of communicable diseases, the management of pandemics, and pandemic-related health products, including promoting equitable access thereto.
Setting these priorities is, at first glance, understandable in the context of the acute nature of a pandemic like COVID-19. There are numerous gaps in the knowledge of how to face scenarios of high uncertainty when facing a new pandemic disease. As argued elsewhere, we are far from living in an ideal world where data is immediately available in the face of novel pathogens.
The problem is, however, that the text of the pandemic agreement remains oblivious to the broader and more basic R&D infrastructure that is a necessary precondition for rapid-response needs. The role of basic research, broadly understood as research ‘not explicitly oriented towards a certain product or an intended practical application,’ but rather to simply expand our knowledge about a subject, is overlooked. Simply put, the success story of the rapid development of vaccines against COVID-19 would have never happened were it not for the vast, preceding knowledge that was produced throughout decades of research. Article 9 disregards the significance of basic research in ultimately generating vaccines and medicines for pandemics. This is a missed opportunity to entrench in the international community an awareness of the often non-linear nature of scientific discovery.
Conclusion: Remembering the Whole, Settling for the Immediate
The pandemic agreement is the first time that the role of R&D in pandemic response has been incorporated into an international treaty. It adopts the idea that boosting R&D capacity in developing countries, as well as improving R&D collaboration with them, is an essential component of pandemic preparedness. In that sense, this is an important improvement.
The purpose of my note was to identify parts of the current draft agreement where I think further reflection is needed. In order to improve equitable access, I have stressed the desirability of developing grant and procurement conditions. More broadly, I’ve emphasized the critical contribution of basic research to pandemic response, and why the pandemic agreement should at least acknowledge its key contributions to life-saving innovations. R&D during the COVID-19 pandemic was simultaneously a success story and a moral failure. A pandemic agreement that is fit for purpose must build upon the former and mitigate the latter.
About the author
Pedro A. Villarreal is a Senior Research Fellow at the Max Planck Institute for Comparative Public Law and International Law and a Research Associate at the German Institute for International and Security Affairs.