After three and half years of intensive negotiations and 13 rounds of meetings the 78th World Health Assembly (WHA), the WHO’s peak decision-making body (comprising of all of 194 sovereign member countries) has adopted the world’s first pandemic agreement by voting (124 in favour, 0 objections and 11 abstained) on May 20, 2025. It is now a legal binding. It was a concerted effort by the Intergovernmental Negotiating Body (INB) that coordinated and facilitated the process to draft the agreement. The process had started when Omicron variant of SARS-CoV-2 was on surge and a disjointed effort was observed on different fronts of the pandemic challenge, which resulted in the death of around seven million people across the globe. There was a huge scarcity of preventive tools and treatment options. In most of the cases there are uneven distribution also. Some countries had more than required vaccines and other pandemic related health products (i.e., vaccines, therapeutics and diagnostics) while others had no access to a single shot of vaccines. So, all the 194 member states of WHO decided to draft a new agreement, or an international instrument for the pandemic prevention, preparedness and response. It was in alignment with article 19 of the WHO constitution. The INB for the same was established in December 2021, at a special session of the WHA. In the 75 year’s history of WHO this is the second international agreement, first being WHO Framework Convention on Tobacco Control, which was adopted in 2003 and became effective in 2005. The agreement has been designed to ensure better global collaborations for equitable and timely access to vaccines, therapeutics and diagnostics by devising principles, approaches and tools for pandemic prevention, preparedness and response.
The agreement is aligned with the International Health Regulations (2005) amendments which were adopted by governments at last year’s WHA to bolster international rules to better detect, prevent and respond to outbreaks. It sets out different tools to work upon, like pandemic prevention and surveillance, One Health approach, building resilient health system, building work force, strengthening of regulatory system, research and development, local production, technology transfer measures, Pathogen Access and Benefit-Sharing (PABS) system, supply chain and logistics, procurement and distribution, societal-governmental level approach, effective communication, international cooperation and finance. The WHO may offer technical support, joint training and continuing education upon request to assist its implementation. It is suggested to consider One Health approach as people’s health is connected with animal as well as environment (called human-animal-environment interface) coordination of which is very much required. A resilient healthcare system, particularly primary healthcare is the basic prerequisite. The development of pandemic related health products (vaccines, therapeutics, and diagnostics) isn’t observed as in the case of other non-pandemic products. An effective vigilance system is also required to monitor safety and efficacy, which must be sufficient enough to respond to substandard and falsified products. The WHO urges collaboration for the processes of Emergency Use Listing, prequalification and any other relevant processes for recommending the use of pandemic-related health products. Scientific research programmes, capacity building programmes, projects and partnerships including joint venture initiatives, with the active participation of international, national and regional collaboration with scientists and research-based institutions and centres, particularly from developing countries need to be started. Rapid and transparent dissemination of information is required like publication of clinical trial protocols and other research results. It is also required to facilitate the sustainable production by the local manufacturers, especially in the developing countries, including promoting transparency of relevant information on pandemic-related health products and also the raw materials across the value chain that is not subject to protection under different national and international law. The agreement also encourages relevant licences or patents holders for the production of vaccines, therapeutics, and diagnostics to waive off or otherwise charge realistic royalties especially to the developing country’s manufacturers during the pandemic situation. It also encourages the transfer of pertinent technology as mutually agreed, including transfer of relevant knowledge, skills and technical expertise, for pandemic-related health products by private rights holders, to established regional or global technology transfer hubs, coordinated by the WHO, or other similar mechanisms or networks. The PABS system defines that in the case of a pandemic situation:
• Each participating manufacturer shall make available to the WHO a rapid access targeting of 20% of their real time production of vaccines, therapeutics, and diagnostics for the pathogen causing the pandemic, with a condition that the 10% of their real time production will be made available to the WHO as a donation, and the rest 10% also to the WHO but at affordable prices.
• The products i.e., vaccines, therapeutics, and diagnostics shall be distributed on the basis of public health risk and related need. The priority should be given to the needs of developing countries, and the Global Supply Chain and Logistics Network.
PABS through an Intergovernmental Working Group (IGWG) will be negotiated over the next 12 months and will be finalized at the next WHA. Once all the aspects of PABS are finalized the agreement will be made public for signature by all the stakeholders i.e., states and different regional economic organizations. After 60 ratifications the treaty will come into force.
There are some criticisms also. Like the treaty does not give WHO powers over individual states with regard to its implementation. It doesn’t give authority to WHO to impose travel bans and impose lockdown. What measures can be taken if a pharmaceutical company hesitates in the investment to deal with the challenges of the pathogen of the time. There has been a delay of more than a year mainly because of non-alignment with global north and global south. The wresting of national sovereignty by WHO has been raised several times throughout the process but the final draft appears to be void. The countries like Poland, Israel, Italy, Russia, Slovakia and Iran abstained from voting which were given a chance to put forward their contentions. The Polish delegation wanted to have the domestic review first, Russia had a concern of state’s sovereignty while Iran had a qualm of not addressing the concerns of developing countries. The US will not be a part of this agreement as it has withdrawn itself from WHO after Donald Trump returned to the White House. The US has criticized this agreement and urged countries to come out of WHO. The absentia of the US is expected to weaken the effectiveness of the implementation.
(The author is a New Delhi based academician and R&D consultant) |