World Health Organization member states have agreed to pursue a legally binding pandemic instrument that will contain “both legally binding as well as non-legally binding elements.”
The majority of WHO member states were in favor of a legally binding instrument but there were differences on how they wanted to proceed. An agreed text released Thursday by the intergovernmental negotiating body — which was tasked to draft and negotiate a WHO convention, agreement, or other international instrument on pandemic prevention, preparedness, and response — concluded that article 19 of the WHO constitution “is the most comprehensive provision under which the instrument should be adopted, without prejudice to also considering, as work progresses, the suitability of Article 21.”
In a closed-off session of the INB on Wednesday that Devex was able to follow, several member states expressed support for a legally binding instrument to be adopted under article 19 of the constitution — which gives WHO a wider scope to address health issues.
Some member states, including the United States, want to keep article 21 — which limits binding agreements to just a few topics — as part of their options while others think it’s too early to decide on one.
The World Health Assembly, the decision-making body of WHO, can adopt a legally binding instrument under both articles of the WHO constitution. But some felt that article 19 is more comprehensive, as it allows the WHA to adopt agreements and treaties on any matter within WHO’s competence and can include measures beyond the scope of article 21.
Only Russia stated a preference for nonlegally binding recommendations under article 23 of the constitution.
Article 19 versus 21
When the World Health Assembly agreed to establish the INB during its special session in December 2021, they agreed for it to work on a pandemic instrument “with a view to adoption under Article 19, or under other provisions of the WHO Constitution as may be deemed appropriate by the INB.”
According to global health law experts, article 19’s advantage is that it allows the WHA to adopt agreements and treaties on any matter within WHO’s competence. An example of a treaty adopted under article 19 is the Framework Convention on Tobacco Control.
“In other words, there is virtually no issue relating to health that an Article 19 treaty cannot cover. This gives the INB wide scope to address not just outbreak detection and response but also wider issues such as zoonotic leaps from animals to humans, antimicrobial resistance, and even climate change as a health threat,” Lawrence Gostin, a professor at Georgetown University and founding O’Neill chair in global health law, told Devex via email.
A treaty enters into force once it reaches the required number of country ratifications. But it means that it’s only applicable to countries that ratified it. Other states can join later, once they’ve done the same.
A treaty, while by definition is “binding,” can have a mix of both binding and nonbinding elements — something that several member states also want.
“Many treaties, albeit formally legally binding, contain hortatory or recommendatory language. One example is the famous Paris Agreement on climate change, whereby parties are not under an obligation to define their national emissions reductions,” said Gian Luca Burci, an adjunct professor at the Graduate Institute of International and Development Studies in Geneva.
Under article 21, the WHA can adopt regulations, such as the International Health Regulations, which govern how WHO and member states operate during a health emergency such as COVID-19. It has limitations though in that international binding instruments under this article can only be adopted under five areas, including sanitation and quarantine, disease nomenclature, diagnostic procedures, and standards for safety and efficacy as well as advertising and labeling of drugs and other medical products.
Unlike treaties, regulations enter into force for all member states at the same time after a deadline set by the WHO director-general, except those that formally object to it.
If not adopted by consensus, article 19 requires a two-thirds vote of the WHA — which Gostin said would be challenging especially if powerful states such as China and the United States oppose it — while Article 21 requires a simple majority vote.
Governance for instruments adopted under the two articles is different as well. A treaty usually has a separate and independent secretariat from its hosting organization, which helps shield it to an extent from the hosting organization’s politics. Meanwhile, regulations are embedded in WHO’s governance, making WHO its secretariat.
“Which one is better depends on what negotiators are looking for,” Burci said. Adding that he thinks that a future pandemic instrument must be legally binding, but both a treaty and a regulation each have their own advantages and drawbacks.
Gostin, on the other hand, said he favors a binding instrument that has “strong compliance mechanisms and full accountability.”
“Many states do want that, but even more are quite concerned that strong binding standards would violate their national sovereignty, and they are reluctant to sign on to anything that is too prescriptive,” he said.
Early in the week, member states also weighed in on a working draft of a potential pandemic instrument. There were a lot of suggestions on what to change, what else to include, and what requires clarifications, including what goes in the IHR — a legally binding instrument governing the way WHO and countries function during health emergencies — and in a potential pandemic instrument. Member states emphasized the need to make sure there’s no duplication and overlap between the two. They also asked for clarity on who would be responsible for implementing the different obligations set out in the draft.
The INB bureau however has stated repeatedly that no decisions are being made at this week’s meeting. They are still not in the negotiation phase, meaning the current working draft will continue to see further changes in the months ahead, with a “conceptual zero draft” to be up for discussions at the INB’s third meeting in December.
“My take on the discussions so far is that there is a general consensus about the need ‘to do something’ but deep differences about the meaning of doing something,” said Jaume Vidal, senior policy adviser at Health Action International.
Jenny Lei Ravelo is a Devex Senior Reporter based in Manila. She covers global health, with a particular focus on the World Health Organization, and other development and humanitarian aid trends in Asia Pacific. Prior to Devex, she wrote for ABS-CBN, one of the largest broadcasting networks in the Philippines.
