The Intergovernmental Negotiating Body has to present the pandemic agreement to the next World Health Assembly in May 2024
Countries have finished the seventh round of deliberations on the pandemic accord to strengthen global prevention, preparedness and response to disease outbreaks that will come into force by May 2024. However, delegates failed to reach a consensus on intellectual property rights and relaxing patents.
These were two contentious issues that stood in the way of equitable vaccine distribution during the COVID-19 pandemic. The United States did not change its stance on the protection of intellectual property rights (IPR), reiterating that canceling them would not improve access for poor countries during emergencies, according to the news website Swissinfo.ch.
Led by South Africa and India, 100 countries had proposed to the World Trade Organization (WTO) in October 2020 that a waiver be issued for intellectual property rights on COVID-19 vaccines and antivirals for at least three years. The proposal was eventually rejected.
The International Federation of Pharmaceutical Manufacturers and Associations was also in agreement when it came to retaining patent rights. “No pandemic treaty is better than a bad one,” the association’s website said.
Developed and developing countries had divergent opinions, according to Swissinfo.ch, reporting on the frontlines from Geneva. The former, industrialised nations, had their focus on prevention, whereas the latter, developing countries, demanded equitable access to medical products to be a guarantee in the treaty. According to Brazil, the measures mentioned so far appear vague.
Geneva Health Files claimed that Namibia’s representative at the Intergovernmental Negotiating Body (INB) was asked to leave early possibly at the behest of the richer nations owing to its strong equity stance. While the US and the European Union denied it, Namibia did not. Geneva Health Files is an investigative, inter-disciplinary reporting initiative that seeks to capture power and politics in global health.
The INB was established by the World Health Organization (WHO) to draft and negotiate the treaty in December 2021. During the two sessions during November 6-10 and December 4-6, 2023, WHO member states deliberated a range of issues. The topics included the financing of future pandemic responses, public health surveillance, One Health, indigenous production of medical products, and transfer of scientific and technical expertise, among others.
Ahead of the negotiations, the latest draft proposal of the treaty was released on October 30, 2023.
It recognised that the “protection of intellectual property rights is important for the development of new medical products, and recalled that intellectual property rights do not, and should not, prevent Member States from taking measures to protect public health”. It further recognised concerns about the effects of intellectual property rights on prices.
“Underscoring the importance of promoting the early, safe, transparent and rapid sharing of samples and genetic sequence data of pathogens with pandemic potential,” the draft read.
Article 11 of the draft document asks members to make use of the flexibilities provided in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
Generally under the World Trade Agreement regulations on intellectual property rights, Article 73 includes Security Exceptions under TRIPS, which is the legal basis for overriding IPR.
In a written submission to the INB on November 10, WTO said that “our experience over the past three years has shown that conversations surrounding the very general term ‘waivers of intellectual property rights’ can raise questions about what practical mechanisms are intended, given that there is no common understanding of this specific phrase”.
The organisation added, “The fact that intellectual property rights are granted and enforced at the domestic level, yet within the framework of international agreements, raises the question of what specific measures would be open to, or expected of the Parties. If WHO Member States were to decide that this provision be retained, further clarification of the following points may be useful to facilitate its effective implementation in practice.”
Moving forward with the treaty, the WTO asked for clarification on two points in particular,
- how this provision would relate to the flexibilities referenced in Article 11.2(c); and
- which “relevant institutions” would frame such waivers, what mechanisms are intended at the domestic level, and how these may relate to existing rights and obligations.
Article 10 of the draft document called on the Parties to establish a multilateral system for access and benefit sharing, under the Pathogen Access and Benefit-Sharing System (PABS).
The PABS Standard Material Transfer Agreement shall include a certain monetary obligation, it added. In the event of a pandemic, real-time access by WHO to a minimum of 20 per cent (10 per cent as a donation and 10 per cent at affordable prices to WHO).
While developed countries agreed in principle, they were unsure of how the governance of the PABS would work. “Developed countries want to be cautious and hope that it will not disincentivise small firms that played a role during the previous pandemic,” a negotiator told Geneva Health Files.
On December 7 and 8, the WHO member states’ sixth meeting of the Working Group on Amendments to the International Health Regulations (WGIHR) discussed financing mechanisms for health emergency preparedness and response.
IHR is the only legally binding mechanism that 196 parties can follow during a public health concern of international importance. It was criticised for being ineffective during the COVID-19 pandemic. So far, more than 300 appeals have been submitted to make amendments.
Co-chair Abdullah Asiri of Saudi Arabia said in a statement, “One of the most critical matters the WGIHR is discussing centers on proposals for a tiered alert system, also referred to by Member States as the ‘public health alert – PHEIC – pandemic continuum’. The greater clarity we achieve on these definitions and the actions they require, the more prepared the world will be for the next pandemic.”
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