The missing heart of pandemic treaty

Perhaps it was the best they could do, given the stark inequities of resources and technology among the nations of the world and the power imbalance in international forums. Perhaps it is natural that after three years of intensive negotiations that started during the COVID-19 outbreak, the worst pandemic in a 100 years, World Health Organization (WHO) members were relieved to agree on some essential steps to make the world somewhat safer from pandemics. The draft agreement finalised on April 16 by the Intergovernmental Negotiating Body (INB) of WHO will be placed for approval by the World Health Assembly meeting coming up in May. If it goes through, would WHO have put in place a more equitable global health security architecture? Maybe not.

The agreement hammered out by INB is undoubtedly a triumph of consensus. But in arriving at a consensus in a multilateral forum, developing countries invariably have to settle for less. As we wrote earlier, it means more give on their part, while the rich nations take more (see “Grab the pathogens, but don’t share the drugs”, Down To Earth, March 16-31, 2024). If Tedros Adhanom Ghebreyesus, WHO’s Director-General, saw it as a victory of multilateralism when the 194-member organisation barring the US agreed on the broad outlines of the pandemic treaty and that “in our divided world, nations can still work together to find common ground, and a shared response to shared threats”, he cannot really be faulted. Three years is pretty good speed for a global pact.

But obviously, there is disappointment, especially on critical elements—primarily the Pathogen Access and Benefit-Sharing System (PABS) that is seen as the best tool to accelerate access to life-saving vaccines, therapies and medical kits during a pandemic. This requires member-countries to quickly share genetic sequences and samples of emerging pathogens for the rapid development of diagnostic tests, therapies and vaccines to fight new pathogen. Rich countries, predictably, have been loath to approve PABS because they are expected to provide in return for the access, a specified quantity of vaccines. The agreement on PABS, which has been hived off as an annex to the treaty, says that each participating manufacturer shall make available to WHO, pursuant to legally binding contracts signed with WHO, rapid access to 10 per cent of their real-time production as donation and another 10 per cent is to be made available at affordable rates “based on the nature and capacity of each participating manufacturer”.

That leaves a lot hanging in the air and few are sanguine about the outcome of forthcoming negotiations on PABS, scheduled to end in May 2026. Much will hinge on how the member-states pursue the negotiations without giving in to WHO bureau edits.

The flypaper has been the intellectual property (IP) concerns of the pharma industry. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the powerful lobby group of the global pharma industry was rather blunt in its stand while stating that it had engaged constructively in the INB process over the past three years. It wants unconditional access to pathogens and relevant data and recognition of the pandemic agreement as a Special International Instrument (SII) in accordance with the Nagoya Protocol, in order to overcome the delays caused by national access and benefit-sharing laws. It also wants guarantees on IP protection and hopes that in subsequent negotiations, member-states will “maintain conditions for the private sector to continue innovating against pathogens of pandemic potential”.

What it offers in return, is allocating a mere 10 per cent of its real-time production of vaccines, treatments and diagnostics for priority populations in lower income countries and taking measures to make them available at affordable rates. How that will make any difference in a pandemic situation is anyone’s guess. Memories of the COVID-19 devastation are still strong, specially in the poor countries where less than 2 per cent of the population had access to COVID-19 vaccines while more than 90 per cent of the people in richer countries had received two doses of the vaccines by the end of 2021. The underlying problem is that several countries did not and still do not have manufacturing facilities, making them totally dependent on the priorities of pharma companies and countries that do have vaccine manufacturing units. Even India reneged on its promise to supply vaccines to Covax, the WHO platform for disbursing vaccines, since it wanted to ensure adequate supplies for its own population. Technology transfer is, therefore, a minefield and much has been left undetermined in the draft agreement.

Ellen ‘t Hoen, a long-time warrior in the battle to ensure access to affordable medicines, regrets that the outcome is not as strong as it should have been, compared to the ambitions with which the negotiations started in 2021. This is because there are few hard new obligations on member-states. Her worry is that many of the provisions are couched in non-committal language, allowing for action only “when deemed appropriate”.

‘t Hoen is now with Medicines Law & Policy, a coalition of experts which works on IP and health, and like other analysts she flags the clauses on technology transfer as vulnerable points. Voluntary sharing of technology and manufacturing can contribute to pandemic preparedness and response, but what happens if rights holders refuse to come forward on a voluntary basis? Can governments take action to ensure access to pandemic technologies, and how?

According to her, Article 11, which addresses technology transfer and has a footnote on “mutually agreed terms, without prejudice to the rights and obligations of the Parties under other international agreements” recognises the right of governments to take other measures to make technology transfer happen. But it is far from reassuring since there is very little that developing countries can do in the face of an outright refusal by private companies. It is not surprising that developed countries, particularly those with manufacturing facilities, rejected the proposal for mandatory technology transfers.

The draft agreement may be a diplomatic success, but it hardly reflects the “unity and unwavering commitment” to the One Health policy that who espouses. Unless there is a concrete plan of action, it will remain a bypass operation leaving the heart of the problem, that is, PABS and tech transfer, uncared for. At best, it provides a broad framework for the work ahead. History is not made in rushed agreements which do not address the most critical health problems of our times.