After the COVID-19 pandemic, all 194 member countries of the World Health Organization reached an agreement to develop an international treaty aimed at preventing, preparing for, and responding to future pandemics. Currently, this document is in the negotiation phase, with the objective of being ready for approval by the World Health Assembly in May 2024. At Salud por Derecho, we have thoroughly examined the document and compiled our findings.
Analysis of the new text of the International Agreement on Pandemic Prevention, Preparedness, and Response
The Intergovernmental Negotiating Body (INB) Bureau has recently published what is expected to serve as the negotiating text for the future World Health Organization (WHO) International Agreement on Pandemic Prevention and Preparedness, hereinafter, Pandemic Agreement, to be considered at the seventh meeting of the INB that will take place at the beginning of November. The adoption of this text by countries will be a crucial moment to announce the start of negotiations on a specific article, which aims to conclude in May 2024. With this text, the States want to ensure the capacity to respond to possible future health crises so that, among others, the same situations of inequity that were revealed with COVID-19 are not repeated.
To achieve this, at Salud por Derecho we have already made clear the need to approve a committed, binding text that puts the general interest of people at the center of the instrument. However, the language of the new Pandemic Agreement draft remains insufficient to achieve its stated objectives, particularly concerning the articles related to equity. While elements of the text dealing with R&D, knowledge and technology transfer, access to pathogens, and equitable sharing of benefits and sustainable production are characterized by a large degree of voluntariness and lack of specificity, other aspects such as surveillance and preparedness are characterized by their legal specification and legal connection. The imbalance between the demands and obligations that all countries will take on to ensure the surveillance and strengthening of national systems to be better prepared also does not include economic compensation for the countries of the global South that will have to make heavy investments without guaranteed support from the wealthiest countries.
Little commitment from Northern countries
The principle of common but differentiated responsibilities has also disappeared from the new text, which is important for understanding that the capacities of countries with lower incomes are more limited if an effort is not made from the North to avoid inequalities. This principle would apply to an entire article where equity in access to technology, financing, or identification of pathogens would ensure compliance, taking into account the differences in capabilities between States.
This contrast reflects the positions of the North, more concerned with developing a surveillance and response system to prevent global spread, as well as the prompt collection of the information necessary for the development of countermeasures, than the perspectives of the South. The South points out the need to adjust these obligations to the development context of each country and that, in many cases, additional financing will be needed to be able to adapt human and infrastructure capacities, while at the same time lobbying so that coping with the pandemic does not repeat the experiences of the past, marked by a lack of global justice regarding the development, production, and distribution of pandemic countermeasures.
In short, what the new text proposes is a system where the obligations assumed do not find reciprocity in the benefits they generate (for example, the case of innovative vaccines that are developed thanks to the information collected by surveillance systems of third countries, whose populations are subsequently denied access to these same vaccines). The result is a proposed text disconnected from the needs of countries with fewer resources, which is unfair to them and raises doubts about its ability to act as a critical instrument to protect global health. Furthermore, the document leaves the WHO without the capacity to assume a coordination role with a clear mandate to address these situations. Its function is limited to the global management of a supply chain that, a priori, would not include measures to break the current concentration of production in Northern countries. It is a missed opportunity to reinforce multilateralism, as we have seen, so necessary in situations of global crisis and to reinforce regional production.
Intellectual property continues to be a barrier
A paradigmatic example of this imbalance and vagueness that hinders more equitable measures is found in the proposal of Article 11. This article contains a commitment to “time-bound waivers of intellectual property rights to accelerate or scale up the manufacturing of pandemic-related products during a pandemic, to the extent necessary to increase the availability and adequacy of affordable pandemic-related products”. At the same time, the language of the articles “encourages” patent holders to consider waiving royalties for manufacturers in developing countries during pandemics, especially those that have received substantial public funding. The text also does not include elements related to open science when discussing public financing, for example, a measure that would facilitate many further developments and shared knowledge.
Although these provisions address intellectual property issues, they do not represent progress in terms of equity. The ambiguity of language around the scope of necessity (“to the extent necessary”) or non-binding (“encourages”) raises concerns about potential interpretations, potentially diluting the impact of intellectual property exemptions during pandemics, leaving decisions on exemptions where appropriate to the discretion of the relevant institutions. In this sense, as shown during the COVID-19 pandemic, it is necessary to advance in terms of technology and knowledge transfer, both to have effective responses and fair and sustainable preparations for pandemics. On the other hand, we have witnessed the lack of political will of the World Trade Organization (WTO) during COVID-19 regarding an exemption in intellectual property related to vaccines and now regarding medicines and diagnoses.
The text again continues to “encourage” the development of collaborations between companies from countries of the North with those of the South ” through WHO initiatives to transfer technology and know-how and strengthen capacities for the timely scale-up of production of pandemic-related products”. Regarding the transfer of technology and know-how, we once again find a language of voluntariness and, therefore, dubious effectiveness regarding the need to both transfer the technology and knowledge necessary for the development of products, as well as the need to share confidential information such as trade secrets. The excessive emphasis on voluntary licenses (the traditional stance of Northern countries) contrasts with the lack of clarity on how to make them a reality in practice, given the widespread failure to promote this option during COVID-19. Furthermore, we have known first-hand the limitations of voluntary licenses and the risks depending on the large variety of license types that can be agreed upon on voluntary terms. In short, it is an insufficient instrument to confront planetary crises that require agile and equitable responses. More opportune measures would involve establishing compulsory licensing mechanisms that are inspired, for example, by the positive elements of the regulatory proposal that the EU is considering for compulsory community licenses, which include trade secrets and know-how.
Although we find a greater obligation to grant non-exclusive licenses for government-owned technologies—although a degree of discretion is maintained with the “as appropriate” formula—it is worth asking why not establish binding transfer and licensing conditions for all those products that have been publicly financed, directly or indirectly. Doing this would constitute a crucial tool to protect the public interest in the early stages of R&D, thus ensuring subsequent conditions of equitable access.
Poorly protected public financing
In general terms, the new text makes even more concessions to the positions closest to the pharmaceutical industry. While in previous versions, we saw how the agreement tried to impose more rigorous conditions that favored access and transparency in the setting of product prices whose R&D had been publicly financed, in the current version, it has been reduced to an obligation to publish the terms of publicly funded R&D agreements, eliminating the need to incorporate more equitable conditions into those agreements. This setback abandons the principle of recognition of vaccines, medicines, and diagnostics as global public goods and prevents the value of public financing and contributions made by taxpayers from being highlighted.
Regarding the equitable distribution of benefits, the proposal to postpone the finalization of the system of access to pathogens and benefits until after the closure of this pandemic agreement (May 2025) is maintained. Decoupling the finalization of this system from the agreement negotiations is a risk to obtaining equity in the pandemic response due to the loss of the power of influence and the making of concessions that allow bloc negotiation with the rest of the agreement. In addition, donations and sales of countermeasures at affordable prices remain a cornerstone of the system, leaving in the background measures that allow more equitable knowledge sharing and diversification of production.
In short, this text does not respond to the objectives for which it was initially created. The principle of security, in terms of general obligations and that of private interest, in terms of R&D, development, and production of countermeasures, will not prevent the injustice experienced with COVID-19. We do not know what the future holds, but it can be predicted that this instrument will not ensure that all people emerge from possible crises on equal terms.