Pandemic Preparedness and Response: Advancing Research, Development, and Ethical Distribution of New Treatments and Vaccines

Abstract

Everyone should have a legally secured human right to health, which includes the right to access essential medicines and vaccines. So adequate pandemic preparedness and response requires putting in place the basic healthcare systems essential for administering them. Moreover, to ensure equitable access to essential medicines, policymakers must advance research and development in a way that does not just serve the interests of those in rich countries. In light of these observations, I suggest some core provisions for the pandemic accord currently under negotiation through the World Health Assembly to advance equitable research, development, and distribution of essential health technologies. Key provisions include commitments to (1) fund pharmaceutical research and development collaboratively. Signatories should require open access research and development financed by advance market commitments or prizes sufficient to cover companies’ costs and ensure sufficient funds for future research and development. Moreover, signatories should (2) provide significant investments in global health infrastructure and these should be equitably distributed based on global need, and (3) ensure that the essential health technologies and the basic health services necessary to support their uptake are available, acceptable, affordable, accessible, and of good quality. Furthermore, until the terms of the accord are fully implemented, signatories should (4) utilize, and support each other’s attempts to extend access to health technologies via, flexibilities in international trade agreements, though signatories’ attempts should not be limited by the terms of these agreements. Moreover, they should (5) set targets, monitor and evaluate performance, and expand access to health technologies as quickly as possible. Anything less is inequitable.

Appendices

Discussion

• Indrani Gupta 

1. Institute of Economic Growth, New Delhi, India

   Indrani Gupta

The COVID-19 pandemic presents an unprecedented global challenge in the control of the pandemic and reducing its health and economic impacts. The health impacts have been large and impacted all countries including developed countries. The pandemic has made it clear that biomedical technologies are critical, particularly diagnostic tests, drugs, and vaccines, and there have been extraordinary levels of concern and worries around increasing access and affordability of medical products.

This paper builds on the important premise that to ensure access to essential medicines, policymakers must advance research and development in a way that does not just serve the interests of those in rich countries. The author proposes a Global Agreement to Advance Equitable Research, Development, and Distribution of New Treatments and Vaccines.

It, therefore, is a very timely contribution to the set of mechanisms that have been advocated to ensure free and just distribution of vaccines and medical products, as the world continues to grapple with various agreements and collaborations to augment treatment and vaccine supplies in an equitable manner across countries.

The Issue

Vaccines and medicines are cited as examples of “global public goods” (GPGs). The UN Secretary-General’s High-Level Panel Report on Access to Medicines outlines efforts to create a new agreement in the WTO and other trade agreements on the supply of public goods (UNSGACCESSMEDS 2016). However, as Global Alliance for Vaccine Initiative (GAVI 2020) points out, while disease eradication as a whole is a public good (vaccination gives non-excludable and non-rival benefits), drugs and vaccines are subject to supply constraints and end up being often both rivalrous and excludable.

This makes the fear of vaccine nationalism in the COVID times real; there has been global nervousness that to safeguard their own interests, countries will “turn more inwardly, collaborate less with global institutions, and become more nationalistic” (Amaya and De Lombaerde 2021). The pandemic has spread due to global connectedness and impacted globally, but countries have responded keeping their national and local interests in mind, “exposing new geopolitical and societal fault lines while exacerbating material divides that make the difference between living and dying (Hyndman 2021).” There are instances of serious and openly inequitious actions like Gilead’s approach to Remdesivir (MSF 2020). In the initial phase, USA refused to join the global COVAX facility that was set up to ensure more equitable distribution of vaccines between countries. There are also instances of countries brokering deals with major pharmaceutical companies to pre-order COVID-19 vaccines (Amaya and De Lombaerde 2021). While the developed countries are far ahead in terms of both production and distribution capacity, the less developed countries need their requirements of vaccines precisely because the pandemic can be halted only when all receive the vaccines they need. Vaccine nationalism is a short-sighted approach to tackle a global phenomenon like COVID-19.

A mechanism to iron out these several issues and bridge the inequities in treatment and vaccine remains as urgent now as in the beginning of the pandemic and is an essential part of pandemic preparedness.

The paper addresses these issues: not only do we need fair distribution of critical products like vaccines, but also need mechanisms for sharing data, knowledge, and the know-how necessary to manufacture quality products and vaccines. These should be treated as global public goods as well. As the author rightly points out, one can invoke right to health and other clauses to make available vaccines and medical products for countries that need them the most. It is in the interest of Big Pharma to get into global alliances and cooperation as well because these countries rely on global pharmaceutical manufacturing supply chains. Thus, India and China as major players can only gain from such agreements.

The paper advocates the following major points that the signatories to the Global Agreement to Advance Equitable Research, Development and Distribution of New Treatments and Vaccines must agree to:

• endorse the human right to health and individuals’ rights to access important medicines as articulated in the Universal Declaration on Human Rights.

• commit to fund pharmaceutical research and development collaboratively through advance market commitments or prizes. Reward systems should ensure sufficient future research and development and companies must provide open access to research and development cost and price data, intellectual property, and resulting products.

• agree to provide significant investments in global health infrastructure, which shall be equitably distributed based on global need.

• secure access to essential medicines by supporting the implementation of, adequate manufacturing supply, transportation and distribution networks, and healthcare infrastructure in partnership with civil society.

• until the terms of the accord are fully implemented, signatories should exercise and support each other’s attempts to extend access on essential medicines using international legal flexibilities available to address public health problems included in the World Trade Organization’s Trade Related Intellectual Property Rights Agreement and other international trade agreements, but their efforts should not be limited by such agreements.

• finally, until signatories have achieved universal access to essential medicines and the health care necessary to support their uptake, without financial hardship, they should set targets, monitor and evaluate performance, and expand access to essential medicines as quickly as possible.

All of these are excellent points, and if the global community can agree to do this, nothing like it. The question, however, is who is in charge, who decides the priorities, who invests, and who allocates? Most importantly, what has changed since the pandemic started that would enable such cooperation to take place in the current situation?

Of course, there have been instances of cooperation before. For example, the global strategy around HIV/AIDS has been fairly successful, with new platforms like the Global Fund for HIV, TB, and Malaria created, which continues to be a key organization that shows that collaboration and cooperation can happen and can help needy countries. With countries like India agreeing to slash prices of available essential HIV drugs, the major obstacles were to a great extent lessened. However, the question of global funding remains the most important concern.

In the case of COVID-19, however, the issues are different and more challenging. The scale of impact has been much higher across countries, with developed countries—who are the pioneers in vaccine development—equally adversely impacted. The mortality and morbidity rates have been much higher than what the AIDS epidemic witnessed. Also, in the case of the COVID-19 pandemic, the cooperation required was for mostly undiscovered drugs and vaccines, and it was not clear what, how, and how much of these would be produced and by whom. Also, the need for vaccination meant that the volume of production required had to be sufficient for the global population—an unprecedented requirement. This unprecedented demand only accentuated the complexity of dealing with GPGs with global benefits spilling across every national border and involving a far wider range of stakeholders—national governments, pharmaceutical companies, organizations involved in scientific research, pharmaceutical companies, nongovernmental agencies, development partners, not to mention the beneficiaries—from all countries.

In this scenario, there will remain conflicting, contradictory, and confrontational interests and incentives of this huge set of diverse stakeholders. Countries have different economic strengths and negotiating power: some are mainly consumers, others are producers, and some are a mix, giving rise to divergent market interests.

It is not clear how these often contradictory objectives can be ironed out in the proposed framework of agreement. The challenge remains in dealing with GPG (Saksena 2021), in that there is no obvious mechanism for resolving them. Who should intervene? What are the mechanisms of bringing countries with diverse health issues, economic situation, production capabilities, and requirements together? What would have changed from the situation the world is in today that would usher in this new era?

To give an example, what kind of incentives will prompt companies to give open access to “research and development cost and price data, intellectual property, and resulting products”, and why would they be more transparent with data? Why should developed countries fund R&D in developing countries if they are not assured of augmented supply? How can one ensure that private interests will not influence global policymaking? Would the consortium work if all countries—especially the ones with significant presence in the vaccine market—do not join the forum?

The only way such a global strategy will work is by adopting an all-or-nothing approach; if some opt out, there will always be incentives to strike bilateral or even multilateral deals, especially in a seller’s market with huge shortfalls in supply requiring explicit or implicit rationing.

The best example of why the suggested steps in this paper may not work is the COVAX facility backed by WHO and GAVI, which was set up as a global procurement mechanism to supply COVID-19 vaccines to all countries in the world. In the face of supply constraints, COVAX also ended up in the vaccine nationalism trap (Usher 2021). “Donor countries and vaccine manufacturers systematically broke COVAX’s principles for maximizing the impact of dose-sharing, delivering doses late, in smaller quantities than promised, and in ad hoc ways that made roll-out in recipient countries difficult” (de Bengy Puyvallée and Storeng 2022).

Also, it is not just availability of drugs and vaccines; estimates indicate that countries will need to spend millions of dollars to vaccinate their populations. The health systems requirement for supporting a mass vaccination program—consumables, storage, distribution, staff—would remain overwhelming. Just a supply of vaccines with countries unprepared to take on mass vaccination might prove counterproductive and inefficient.

With ravaged economies and high health costs, national governments may not right now have the bandwidth to engage in the fairly complex negotiation outlined in the paper. Instead, their priorities should be health systems strengthening, expanding in-country production capabilities of medical products and raising finances to build up a resilient health sector.

Vaccine inequities continue despite efforts by international organizations like the WHO and World Bank, and there seems to be no immediate mechanism to these inequities. The only hope is for more and more vaccines to emerge and from developing countries as well. That would ease up supply and help in reducing the inequities.