Transparency mandate embedded into the proposed amendments to the International Health Regulations: Rationales underpinning the proposed Bureau’s text

On 17 April 2024, the World Health Organization (WHO) published the Proposed Bureau’s text in advance of the 8th meeting of the Working Group on Amendments to the International Health Regulations (2005) (WGIHR) which meets from 22–26 April 2024. Accompanying the 64 page Bureau text is an accompanying, non-public document on the rationales underpinning the proposed Bureau’s text for WGIHR 8. Third World Network
(TWN) and Geneva Health Files (GHF) have reported on aspects of the Bureau’s rationale document. This piece will focus on the equity provisions of the Bureau text and their rationale underpinning their textual choices. The Rationales document (originally prepared on 15 April 2024) was updated on 17 April 2024 to include the “rationale for sub-paragraphs 8(d) and 8(e) of Article 13 Public health response, including access to health products”.

Inserted on the cover page of the Bureau’s 64 page text is this note: “Additions to and deletions of the current IHR text appear in bold and strike-through respectively”. Article 13 on Public health response, including access to health products now includes three new sub-paragraphs (13.7, 13.8, and 13.9).

Article 13.7 states:

WHO shall support States Parties and coordinate response activities during public health emergencies of international concern, including pandemic emergencies. To facilitate equitable access to health products, this support shall include, as necessary, coordinating with mechanisms and networks that facilitate equitable allocation and distribution of health products, including through technology transfer on mutually agreed terms. The aforesaid mechanisms and networks may include, but are not limited to, regional ones and those established under relevant international agreements.

Article 13.7 envisions that WHO plays a coordinating role among State Parties during public health emergencies of international concern. This coordinating role involves the facilitation of equitable access to health products, “including through technology transfer on mutually agreed terms.”

In its rationale, the Bureau notes:

Paragraph 7

The Bureau underscores that the only “Parties” to the Regulations are States Parties and the WHO Secretariat. Therefore, IHR provisions exclusively bear responsibilities either for States or for the WHO Secretariat.

Therefore, considering:

That Article 2(a) of the WHO Constitution states that “In order to achieve its objective, the functions of the Organization shall be: (a) to act as the directing and co-ordinating authority on international health work”; and

That, in the current global landscape, there are numerous mechanisms and networks that could contribute to equitable access to health products, and that such mechanisms and networks are operating under the auspices of entities with which WHO in in official relations with;

the Bureau is proposing to establish the obligation for WHO to coordinate with relevant mechanisms and networks. However, the Bureau recognizes that, since entities other than States Parties and WHO bear no obligations under IHR provisions, the WHO Secretariat cannot be held accountable of the ultimate outcome of its coordinating efforts.

Article 13.8(a) states:

In its rationale, the Bureau makes a direct link to the WHO transparency resolution.

Letter (a): The Bureau notes that (i) this Sub-paragraph is partially derived from resolution WHA72.8 (2019); and (ii) the phrasing aim at capturing the eventuality that when the first set(s) of temporary recommendations are issues, the assessment(s) referred to in the Sub-paragraph may not be available.

Article 13.8(e) states:

The Bureau provides a detailed rationale for programs and activities to strengthen local production. The rationale mentions, inter alia, the World Local Production Forum,, H-TAP (Health Technology Access Pool), and mRNA Technology Transfer programme.

Letter (e): In support of resolution WHA74.6 on local production, the WHO Secretariat supports member states to promote sustainable local production of quality assured health product through:

Organising the World Local Production Forum (WLPF), WHO initiative that provides Member States and the global community with a regular platform to shape strategies, galvanize collective action, and foster partnerships on sustainable local production to improve timely and equitable access to quality assured health products: https://www.who.int/initiatives/world-local-production-forum

Providing Specialized Technical Assistance to help recipients achieve compliance with international regulatory norms and standards, so that they can attain WHO prequalification (PQ) for priority products or services, or emergency use listing (EUL) for unlicensed products to be used in the context of a public health emergency, and/or supply quality-assured products required by United Nations (UN) Agencies, their partners and procurement agencies serving WHO Member States:

https://www.who.int/teams/regulation-prequalification/lpa/technical-assistance-for-who-prequalification
https://www.who.int/teams/regulation-prequalification/lpa

Assessing the ecosystem for local product. WHO assists governments to conduct holistic situational analyses with a tool to identify gaps in key areas for promoting sustainable and quality local production, such as policy coherence, the business environment, regulations and quality assurance, infrastructure, and the market landscape of the national industry: https://www.who.int/teams/regulation-prequalification/lpa/situational-analysis-and-readiness

Bio-manufacturing training Hub: https://www.who.int/initiatives/biomanufacturing-workforce-training-initiative

Through H-TAP (Health Technology Access Pool), bridging the health technology access gap by providing an evidence-based, transparent framework and process for selecting, securing and supporting the transfer of technology with the goal of promoting innovation and the sustainable, geo-diversified production of health products.: https://www.who.int/initiatives/who-health-technology-access-pool

mRNA Technology Transfer programme: https://www.who.int/initiatives/the-mrna-vaccine-technology-transfer-hub

In relation to the proposed Bureau’s text, published on April 17th, one thing that pops out of the text is the transparency mandate contained in Article 13.9(c) which calls upon state parties to publish “relevant terms of government-funded research agreements for health products needed to respond to a public health emergency of international concern, as well as information, where relevant, on pricing policies regarding these products and technologies, in order to support equitable access.

Article 13.9 states:

The Bureau’s rationale states:

Through the proposed New Paragraph 9, the Bureau intends to outline the nature of the collaboration that States Parties may undertake under these Regulations to contribute to response efforts, and to equitable access to health products under those circumstances.

Chapeau: The Bureau intends to emphasize that extraordinary efforts by States Parties may be needed.

Letters (b) and (c): As indicated in the rationale of the proposed Article 13A, presented at resumed WGIHR7, the Bureau notes that the wording of this Sub-paragraph is derived from the draft Pandemic Agreement presented at INB8.