As negotiations over the WHO’s Pandemic Preparedness Agreement continue, disputes over intellectual property, pathogen sharing and global equity threaten to undermine one of its most important provisions. Without a fair Pathogen Access and Benefit-Sharing system, the inequalities exposed by COVID-19 risk being repeated.
The World Health Organization (WHO) successfully facilitated negotiations to develop the text of The Pandemic Preparedness Agreement. Aimed at improving global health systems to effectively prepare for, prevent and respond to pandemics, this agreement has been hailed as a significant success as governments across the world in the aftermath of COVID-19 strive to build their resilience in the event of any future global health catastrophes. Unfortunately, however, the one of the most difficult, and consequently critical, elements within the agreement – Article 12 Annex addressing the Pathogen Access and Benefit-Sharing (PABS) system – remains in a deadlock.
The PABS will define the governance framework for managing rapid identification of pathogens with pandemic potential and sharing that genetic information to enable research and production of vaccines/tests etc. Yet to be agreed upon, however, is the framework for access to these pandemic resources and how the benefits will be allocated equitably and fairly. The negotiations are narrowing into two distinct positions: The Federated Model led by South Africa and the EU/Japan Hybrid Model. The legacy from the Covid-19 experience – of unequal access for developing countries to life-saving vaccines – fundamentally informs these PABS negotiations.
Finalising these PABS Article 12 negotiations will also involve considerations of international trade, of intellectual property rights, of access to and control over naturally occurring genetic resources and raises issues of sovereignty and national security concerns. Added to this are complex technical issues around operating in a scientific environment with a range of global/national genetic databases.
These elements will come into play in finalising this politically sensitive PABS ‘access and benefit sharing framework’. However, an ongoing issue – intellectual property rights – continues to be point of contention for countries in agreeing upon the voluntary sharing of viruses with pandemic potential.
Intellectual Property Rights: Barriers to Equitable Knowledge-Sharing
WTO negotiations did not politically recognise consequences for these important multilateral collaborative arrangements that became subjected to the newly introduced globalised Intellectual Property obligations (TRIPS).
Around 2000 the new IP legal and access constraints became obvious. Several from the Global South responded challenging the IP being applied over their seeds, sourced freely from Global Seed Banks, managed through the Food and Agricultural Organization (FAO)
This was the first major multilateral confrontation over the patenting of global resources that had otherwise been accessed free for decades. Developing countries (and even some developed countries) were being challenged as they now began to comprehend the scope of the WTO IP TRIPS regime, including the flow-on to the negotiations on the Convention on Biological Diversity. The FAO negotiations were therefore highly toxic and lasted for seven years. The US but also Australia and some other developed countries sought to maintain access to seed banks and the right to patent these resources in specific situations. The compromise that eventually emerged recognised sharing of these global resources was essential but only continued after an ‘access and benefit arrangement’ was agreed.
This new formulation for exchange of ‘seeds’ – the International Treaty on Plant Genetic Resources for Food and Agriculture – included conditionality that it would work in harmony with the Convention on Biological Diversity.
Similar access problems arose for the operation of the World Health Organization’s strategic global sharing of viruses through the 1953 Global Influenza Surveillance and Response System (GISRS). Several Asian countries signalled their intention to block access to crucial influenza viruses until a fair access and benefit sharing arrangement was agreed. Collaboration was maintained by negotiating The Pandemic Influenza Preparedness Agreement .
The current security challenge is to develop an acceptable political ‘access and benefit agreement’ under Article 12 of the Pandemic Preparedness Treaty, that from the Global South’s position is legally binding. They now approach these negotiations determined to challenge the many failures experienced that led to lack of access to medical products and high Covid death rates.
These Article 12 PABS negotiations also present a formidable challenge for Diplomats. The issues involve understanding the complexity in developing earlier access and benefit sharing agreements and the current challenges to develop a process that can identify and share genetic sequences in crisis situations. As well as contentious positions adopted by the pharmaceutical corporations advanced by specific developed countries.
The World Health Assembly, negotiations resumed 6–17 July but positions remain problematic leaving key players to continue informal dialogue. UN leadership and NGOs, including in Australia, are actively lobbying, political leaders to recognise health and security consequences and to seriously elevate negotiations.
The political arguments around Article 12 PABS negotiations were known. The failure to collaborate and share essential resources with many in the Global South during the Covid Pandemic has further antagonised negotiations. And IP related issuescontinue to reverberate. This is despite the Covid experience where so much invention evolved from public health and academic institutions and governments provided the economic and health support to protect their citizens.
Many member states of the Global South, led by South Africa, understand very well how voluntary collaboration failed to deliver when these countries were at their most vulnerable. This was despite the example of Botswana and South Africa, who identified the Omicron strain, and immediately shared with the WHO to facilitate global distribution of this new genetic variant but still suffered delayed access to vaccines and treatments. It would be a mistake to underestimate how these obvious failures now politically inform the PABS negotiations.
Navigating Global Power Politics
While these political, trade, IP and legal issues continue to block agreement there are other global events that could be as prejudicial to securing this vital global health agenda. The US abandonment of its membership of the WHO creates a substantive problem not just from a financial perspective but also in accessing its formidable scientific contribution to global health.
Dramatic cuts to US development aid programs will continue to resonate negatively for many developing countries. And at the national level the work of the US’ security-focused Biomedical Advanced Research and Development Authority (BARDA) may not be as accessible to the populations that would benefit the most from them. This includes groundbreaking research developing medical countermeasures to pandemics – alerting to both intended and unintended outbreaks. BARDA’s research is highly significant providing security focused guidance and funds for research, development and stockpiling.
With the US now outside of the WHO (and negotiations to finalise the Pandemic Preparedness Agreement) it is charging ahead creating bilateral agreements with African countries. They link collaboration in health and access to aid to the US accessing any new or emerging pathogens. This is a cause of concern as US pharmaceutical corporations may gain exclusive access to possible pandemic viruses without obligations to make vaccines and treatments available to low-income countries.
From very much inside the negotiating tent China stated access by pharmaceutical manufactures should be “…contingent on their home country being a party to the Pandemic Agreement”. While this might represent a ‘placemark’ for further discussion given the US and others remaining outside the WHO, we have yet to see whether this Chinese position prevails.
Russia also raised the problem of enabling access to viruses that could be weaponised if falling into the wrong hands. Another underlying security challenge in drafting the PABS.
Overall, these negotiations are technically and politically challenging. But these issues can be addressed, as Brazil and the WHO emphasise, if leaders actively engage to deal with any trade, economic or political blockages. Fundamentally, Article 12 PABS Annex must ensure that low and middle-income countries which share critical samples and data, cannot in future be the last to benefit from medical innovation.
Negotiations reconvene 14-18 Sept focusing on – Africa’s Federated Model and EU’s Hybrid Model. An interesting NGO alternative, advocated by Knowledge Ecology International, has also been flagged.
Anna George is a former Australian ambassador, adjunct professor at the Sir Walter Murdoch School of Public Policy and International Affairs at Murdoch University, and associate fellow at the Centre on Global Health Security, Chatham House.
This article is published under a Creative Commons License and may be republished with attribution.
