Getting in Formation: WHO Constitutional Heads of Power and the Pandemic Agreement

[Alexandra L Phelan is an international lawyer, Senior Scholar at the Johns Hopkins Center for Health Security, and Associate Professor at the Johns Hopkins Bloomberg School of Public Health. 

Nina Schwalbe is the Principal at Spark Street Advisors, an adjunct assistant professor at Columbia’s Mailman School of Public Health and Principal Visiting Fellow at United Nations University International Institute for Global Health.]

WHO Member States are in the final stretch of negotiating the proposed Pandemic Agreement. A rapid timeline is shortening in front of them: presently in their eighth meeting of the Intergovernmental Negotiating Body (INB), states have one final scheduled negotiating session in March with the goal of adopting an instrument at the May 2024 World Health Assembly (WHA). While discussions have focused significantly on substantive issues, such as pathogen access and benefits sharing, the first week of this round of negotiations has seen a more formative question re-emerge: under what head of power in the World Health Organization (WHO) Constitution should the instrument be adopted? 

When launching the negotiation process in late 2021, WHO Member States adopted a resolution stipulating the establishment of an INB to draft and negotiate “a convention, agreement or other international instrument” under the WHO Constitution. This provided for a broad range of potential heads of power under which the WHA – the primary decision-making body of the WHO – can make laws: from the classic treaty power under Article 19, the opt-out regulations power under Article 21, or the non-binding recommendations power under Article 23. The WHA has embraced this array of law-making powers for international instruments over the years: the WHO Framework Convention on Tobacco Control (FCTC) was adopted under Article 19; the legally-binding International Health Regulations (2005) (IHR) under Article 21; and the non-binding Pandemic Influenza Preparedness Framework under Article 23.

In June 2022, the vast majority of Member States expressed favor for a binding international instrument (i.e. Articles 19 or 21), with negotiating countries determining that Article 19 provided “the most comprehensive provision under which the instrument should be adopted”. However, Member States made this determination “without prejudice to also considering, as work progresses, the suitability of Article 21”. 

Over the last two years of negotiations, the form of the treaty seemed settled on Article 19. However, this week, with only one scheduled ten-day negotiation session remaining, the possibility of adopting the Pandemic Agreement under Article 21 has substantively re-emerged. Some negotiators have indicated that this may require significantly narrowing the scope of issues covered in the proposed text, while others have hoped that doing so would result in greater participation in the adopted agreement. While this may seem to many a simple question of an “opt in” or “opt out” approach, the legal and normative realities are somewhat more nuanced and require careful consideration by negotiators.

Article 19 reflects a treaty power most commonly seen in international law: the WHA has the “authority to adopt conventions or agreements with respect to any matter within the competence of the [WHO]” requiring a two-thirds majority vote. States then become Parties to the treaty by signing and ratifying or acceding to the treaty, with the treaty entering into force once it achieves a specified number of States Parties. 

In contrast, Article 21 reflects a relatively unique international law-making power, whereby the WHA has the “authority to adopt regulations concerning” a specific list of topics, including “sanitary and quarantine requirements and other procedures designed to prevent the international spread of disease”. Once adopted by the WHA, Member States are then automatically legally-bound by the relevant regulations following a specified period of time unless they expressly opt out. 

When the IHR were significantly revised in 2005, no WHO Member State opted out of the instrument. In fact, two additional states, Holy See and Liechtenstein, chose to become States Parties, binding 196 States Parties. Further, the regulations came into force after only two years, rather than the sometimes-lengthy process required under international law when waiting for a minimum number of Parties. For context, when the WHO FCTC was adopted, it took nearly two years to get the minimum number of 40 States Parties, and now, two decades on, the treaty has more than 180 States Parties.

The revised IHR include a range of obligations on States Parties to build core public health capacities from the local to the national level, limitations on the imposition of control measures, and reporting obligations for potential public health emergencies of international concern. In comparison to past iterations of the IHR, this reflected a broadening of the interpretation of Article 21(a) which stipulates regulations may be made with respect to “sanitary and quarantine requirements and other procedures designed to prevent the international spread of disease”. 

Because of this subject-matter limit, some negotiators have privately raised concerns that adoption of the Pandemic Agreement under Article 21 could require removing significant parts of the current treaty content in order to meet this scope requirement. Others have argued that Member States have previously read the scope of Article 21 broadly and could arguably do the same here for the Pandemic Agreement. This will depend on what pandemic prevention, preparedness, and response activities Member States consider falling under the scope of “other procedures designed to prevent the international spread of disease”.

The drafters of the WHO Constitution gave “considerable attention” to the regulations law-making power, including whether the specific list of topics subject to regulations was intended to be restrictive. The drafters agreed that the regulations power “should be inclusive of all the subjects upon which the [World Health Assembly] might act”. Despite this, general principles of interpretation would likely require sufficient nexus between the express list of items specified under Article 21 and the subject matter of any regulation. For example, Member States would need to interpret that provisions related to health care workforce fall under the scope of “other procedures designed to prevent the international spread of disease”. If Member States cannot find consensus on this broad approach, they may choose to interpret Article 21 narrowly – either preferring Article 19 as a more comprehensive head of power, or significantly modifying the content of the current negotiating text to strictly fit. This latter approach risks undermining the sufficiently comprehensive international law reform necessary to improve pandemic prevention, preparedness, and response globally. 

Beyond scope, there are several further legal and normative implications of choosing Article 21 over Article 19.  The most significant is that once it enters into force – after a time frame determined by the WHA to be sufficient due notice – the instrument would become immediately binding on Member States unless they expressly opt out. This carries significant advantages for a global challenge requiring international coordination, with countries’ obligations realizing immediately all at once, universally. It avoids delays to the treaty being implemented and would be instant buy-in to key provisions such as any pathogen access and benefits sharing system and financing arrangements. Further, it also shifts the “burden to act” on states who do not wish to participate or actively disagree with components of the instrument to actively opt out, reducing the barrier to becoming a party to the agreement. Negotiators should pay careful attention to how the decision is structured: if Member States proceed with an Article 21 Pandemic Agreement and States begin to opt out, there may be normative implications beyond that instrument alone. In other words, Member States that actively opt out of the Pandemic Agreement may change the acceptability of opting out, lowering the threshold for opting out of parallel amendments to the IHR that are currently underway. Negotiators should keep these potential normative echoes in mind if pushing ahead using Article 21 without sufficient consensus.

Another consideration that has been raised by negotiators is logistics. Some Member States have argued having two sets of regulations – the IHR and a Pandemic Agreement adopted under Article 21 – could reduce fragmentation. This is less compelling.  Regardless of whether the Pandemic Agreement is adopted under Article 19 or 21, back-to-back meetings of parties for each instrument could be established to time with the WHA, allowing dedicated space for States Parties to discuss the instruments. There is nothing in pursuing Article 21 that guarantees completely identical Party membership between regulations. 

It is important also to distinguish between what is dependent upon the choice of head of power, versus what is a choice within the text of the agreement.  For example, the recently released text of the governance chapter of the draft Pandemic Agreement proposes a new WHA committee rather than a conference of parties (COP) mechanism. While the Article 19 WHO FCTC uses a COP mechanism, and the current IHR uses the WHA for governance, determining the governance body is a separate question for negotiators than the head of power question. 

Ultimately, a COP mechanism may provide a more ready opportunity for implementing a robust governance system and a regular forum for dialogue and accountability. Negotiators may be more easily able to ensure greater participation for non-state actors and responsiveness to evolving challenges in a COP body than the WHA, which has existing procedures on participation and a universal mandate. As a result, a WHA governance structure may send the message that responsibly for preparedness and prevention is limited to WHO Member States and their health ministries. By practice and practicality, but not necessarily legally prohibitive, a classic treaty under Article 19 with a COP mechanism may also more readily incorporate text that permits groups of states, such as the African Union or European Union, becoming parties in their own right. 

Finally, there is the issue of perception on the normative differences between an Article 19 treaty and one adopted under Article 21. Will adopting the Pandemic Agreement as a regulation under Article 21 render it to the status of a technical instrument, unfamiliar to the highest levels of government? 

Business as usual was insufficient to address the whole-of-society challenge of responding to COVID-19. While the pandemic roared, the world was keen to see a new and bold approach to collaboration between countries, with accountability laying at the highest levels of government, and pandemic prevention and financing as critical as outbreak response. While ongoing negotiations may see debate about form as simply a matter of legal interpretation, Member States must be cautious in ensuring that their chosen approach does not undo their work to date in negotiating a comprehensive Pandemic Agreement or undermine the scope of law-making powers available for future global health law-making.