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TWN Info Service on Health Issues
7 June 2024
Third World Network
www.twn.my
WHO: IHR 2005 amendments adopted, includes equity-related provisions
Kochi/Geneva, 3 June (Nithin Ramakrishnan and K M Gopakumar) – The WHO Member States at the 77th Session of the World Health Assembly (WHA77) adopted a package of amendments to International Health Regulations (IHR) 2005 that included equity-related provisions.
These provisions attempt to address the concerns on lack of equitable access to health products such as vaccines, therapeutics and diagnostics for health emergency preparedness and response.
The WHA77 took place at the Palais de Nations in Geneva from 27 May to 1 June 2024.
The adoption of the IHR amendments concludes a two-year process initiated in 2022. The purpose and the scope of this process was set out in the decision of the Executive Board (EB) in 2022.
EB Decision 150.3 urged Member States “to take all appropriate measures to consider potential amendments to the International Health Regulations (2005), with the understanding that this would not lead to reopening the entire instrument for renegotiation. Such amendments should be limited in scope and address specific and clearly identified issues, challenges, including equity, technological or other developments, or gaps that could not effectively be addressed otherwise but are critical to supporting effective implementation and compliance of the International Health Regulations (2005), and their universal application for the protection of all people of the world from the international spread of disease in an equitable manner.”
This decision was reiterated in the 75th WHA decision, which was followed by a call for written submissions on amendment proposals. Several States Parties had proposed amendments to the IHR 2005, including Armenia, Bangladesh, Brazil, Czech Republic on behalf of the Member States of the European Union, Eswatini on behalf the WHO African Region Member States; India, Indonesia, Japan, New Zealand, Russian Federation on behalf of the Member States of the Eurasian Economic Union, Switzerland, United States of America, and Uruguay on behalf of MERCOSUR.
The proposals from the developing countries stressed on developing legal obligations and mandate on States Parties and WHO respectively, to enable equitable access to health products and technologies required for public health emergency preparedness and response for all populations.
The Africa Group and Bangladesh had also proposed expansion of Annex 1 of IHR 2005, i.e. core capacities for health preparedness and response, which was supplemented with demands for a financial mechanism accountable to IHR States Parties. Certain other countries like India and Malaysia had also proposed amendments for expansion of Annex 1. Several of these proposals and demands have been accommodated in the final package of the IHR amendments, albeit not in its original form as proposed by the proponents.
The Working Group on Amendments to the IHR (WGIHR) negotiated, based on the compiled text proposals from States Parties, over 7 rounds of negotiation from March 2023 to May 2024. The Co-Chair and the WGIHR Bureau also proposed meaningful alternative text proposals to bring diverging States Parties closer and to arrive at consensus. Since the WGIHR failed to arrive at full consensus before the WHA77, a Drafting Group of WHA further discussed the amendment proposals with the aim to build final consensus. The drafting group worked on the basis of document A77/9, submitted by the WGIHR for the consideration of the WHA, which contained the text of amendment proposals reflecting initial consensus and convergences arrived during the WGIHR meetings.
The WGIHR Co-Chairs along with the co-chairs from the Intergovernmental Negotiating Body (INB) working in parallel to develop a WHO Pandemic Agreement, convened the drafting group meetings during WHA77 and submitted a consensus package of amendments to the WHA as contained in the conference paper A77/A/CONF./14. This package of amendments, as finalised by the drafting group, were annexed to a draft resolution co-sponsored by France, Indonesia, Kenya, New Zealand, Saudi Arabia and the United States of America which was adopted without any objections.
These amendments among others create legal obligation on WHO to take measures to address equitable access and also establish a financial mechanism to mobilise resources for the implementation of IHR. A new implementation committee was also established consisting of all State Parties to discuss the issues related to implementation.
Major amendments targeting equity
(a) Access to health products
Article 13 is amended to provide for international assistance to facilitate equitable access to health products such as diagnostics, vaccines and therapeutics for responding to public health emergencies of international concern (PHEICs) as well as pandemic emergencies. There are three newly added paragraphs to Article 13 providing for such support.
New Paragraph 7 makes it a mandate of WHO to support IHR States Parties in general during PHEICs, including pandemic emergencies. WHO is mandated to coordinate international response activities.
New Paragraph 8 further explains the role of WHO in facilitating timely and equitable access by States Parties to relevant health products. According to this paragraph it is the mandate of the WHO to facilitate access as well as work towards removing barriers to such access. In this regard, WHO shall periodically assess the public health needs, as well as of the availability and accessibility including affordability of relevant health products, publish them and take into account such assessments while issuing recommendations pursuant to Articles 15-18.
Furthermore, under Paragraph 8 of Article 13, WHO is mandated to use the coordinated mechanisms and networks for allocation and distribution, both coordinated by WHO as well as others, to facilitate equitable access. It should also provide support to States Parties, upon their request, in scaling up and geographically diversifying the production of relevant health products. In doing so, WHO should promote research and development and strengthen local production of quality, safe and effective relevant health products, and facilitate other measures for full implementation of the provision. WHO also has gotten a mandate to share product dossiers with States Parties for the purpose of facilitating regulatory evaluation and authorization of health products.
The obligation under this paragraph is further strengthened under amended Paragraph 2(d) of Article 44 which now reads: “WHO shall collaborate with, and assist, States Parties, upon their request, to the extent possible, in… (d) the facilitation of access to relevant health products, in accordance with paragraph 8 of Article 13”. This will help States Parties to seek assistance from WHO in addressing the barriers to equitable access.
Interestingly, according to Paragraph 9, States Parties are also obligated, subject to applicable law and available resources, to support WHO in implementing the actions outlined in Article 13 (on equitable access to health products and technologies). They are further mandated to engage with and encourage relevant stakeholders operating in their respective jurisdictions to facilitate equitable access to relevant health products for responding to a PHIEC and a pandemic emergency. They are also required to make available the relevant terms of their research and development agreements for relevant health products, related to promoting equitable access to such products during PHEICs and pandemic emergencies.
The term “relevant health products” is defined in Article 1 as “those health products needed to respond to public health emergencies of international concern, including pandemic emergencies, which may include medicines, vaccines, diagnostics, medical devices, vector control products, personal protective equipment, decontamination products, assistive products, antidotes, cell- and gene-based therapies, and other health technologies”.
The most striking feature of the definition of health products is that now it includes health technologies as well. More importantly, Annex 1 of IHR 2005, which provides for the IHR core capacities, now explicitly recognizes “access to health services and health products” as core capacity both at the national and sub national (intermediate) levels.
This would allow the developing countries to claim more support and assistance in building, maintaining, developing and strengthening capacities for local production, procurement, storage and distribution of medical products as well as primary health care capacities.
Articles 15-18 and 49 are also amended, enabling the WHO Director-General to issue temporary and standing recommendations relating to relevant health products. For instance, amended Article 15 states:
“2. Temporary recommendations may include health measures to be implemented by the State(s) Party(ies) experiencing the public health emergency of international concern, including a pandemic emergency, or by other States Parties, regarding persons, baggage, cargo, containers, conveyances, goods, including relevant health products, and/or postal parcels to prevent or reduce the international spread of disease and avoid unnecessary interference with international traffic.
2 bis. The Director-General, when communicating to States Parties the issuance, modification or extension of temporary recommendations, should provide available information on any WHO coordinated mechanism(s) concerning access to, and allocation of, relevant health products, as well as on any other allocation and distribution mechanisms and networks.”
The incorporation of principles of equity and solidarity under Article 3(1) ensures that the implementation of the Regulations should promote equity and solidarity and this would in turn be considered as playing a significant interpretative role in the provisions of Articles 13, and 15-18.
[Article 13: Public Health Response including Equitable Access to Relevant Health Products; Article 15: Temporary Recommendations; Article 16: Standing Recommendations; Article 17: Criteria for Recommendations; Article18: Recommendations with respect to persons, baggage, cargo, containers, conveyances, goods and postal parcels.]
(b) Access to Financing
Article 44 has been amended to increase international collaboration and assistance including for mobilisation of additional financial resources. The States Parties and WHO are mandated to collaborate and assist to strengthen sustainable financing to support the implementation of IHR.
The States Parties undertook to encourage governance and operating models of existing financing entities and funding mechanisms to be responsive to the needs and national priorities of developing countries. More importantly, they agreed to identify and enable access to financial resources, necessary to equitably address the needs and priorities of developing countries, including for developing, strengthening and maintaining core capacities, including through the establishment of a Coordinating Financial Mechanism (CFM), pursuant to Article 44 bis.
A new Article 44 bis has been incorporated into IHR 2005 to define the CFM. The functions of the CFM are threefold:
“(i) promote the provision of timely, predictable, and sustainable financing for the implementation of these Regulations in order to develop, strengthen, and maintain core capacities as set out in Annex 1 of these Regulations, including those relevant for pandemic emergencies;
(ii) seek to maximize the availability of financing for the implementation needs and priorities of States Parties, in particular of developing countries; and
(iii) work to mobilize new and additional financial resources, and increase the efficient utilization of existing financing instruments, relevant to the effective implementation of these Regulations”.
The CFM will function under the authority and guidance of the World Health Assembly and is accountable to the assembly. The terms of reference of this mechanism, and modalities for its operationalization and governance are yet to be decided. A newly formed States Parties Committee for the Implementation of IHR 2005 is mandated to adopt the same under Article 54 bis of the Regulations.
(c) Governance
One of the major demerits of the implementation of IHR 2005 was that there was no appropriate forum to discuss in detail the challenges, strengths and weaknesses in the implementation of the IHR 2005. All that was allotted were some sessions during the annual meetings of the WHA.
The newly incorporated Article 54 bis establishes the States Parties Committee for the Implementation of the International Health Regulations (2005), which would meet at least once in two years. It would work with the aim of promoting and supporting learning, exchange of best practices, and cooperation among States Parties for the effective implementation of these Regulations, in particular Article 44 and 44 bis. The work of the Committee is also aided by a sub-committee for providing technical advice.
The Committee is therefore able to give directions and guidance as to international collaboration and assistance, and other coordinated activities of the WHO to improve the implementation of IHR 2005.
The refreshed Annex 1 has also added new capacities to be developed by the States Parties, and the prime focus of Article 44 is to provide support and assistance in building, maintaining and developing these capacities.
Previously, technical support and international assistance focussed more on surveillance capacities as they are the donor priorities among all the capacities contained in Annex 1. However, with the new mandate under Article 44 bis and the effective governance oversight by the States Parties Committee for Implementation of IHR 2005 under Article 54 bis, international assistance and cooperation can now also be channelled to realize developing country priorities too.
The Committee can also look into the implementation of Article 13 that includes provisions for equitable access to health products and technologies, as discussed above.
Other (Selected) Amendments
(i) Pandemic emergency as the new category of the PHEIC
Article 1 incorporated a new category of PHEIC identified as pandemic emergency and is defined as follows:
“pandemic emergency” means a public health emergency of international concern that is caused by a communicable disease and: (i) has, or is at high risk of having, wide geographical spread to and within multiple States; and (ii) is exceeding, or is at high risk of exceeding, the capacity of health systems to respond in those States; and (iii) is causing, or is at high risk of causing, substantial social and/or economic disruption, including disruption to international traffic and trade; and (iv) requires rapid, equitable and enhanced coordinated international action, with whole-of-government and whole-of-society approaches.
The definition of pandemic emergency is further supplemented by a process under Article 12 enabling the WHO Director-General to determine the pandemic emergency status of a public health event.
Most of the provisions on taking measures to prevent, prepare for and respond to PHEIC have been revised to incorporate an explicit mention of pandemic emergency. This enables better coherence of WHO’s emergency activities as the IHR can apply to pandemic emergencies, irrespective of outcomes of the INB process for a new pandemic agreement.
(ii) Expansion of National Authorities
Article 4 of IHR 2005 has been amended to ensure that there is both a National IHR Authority and a National Focal Point. The amendment is further augmented by incorporation of new Paragraph 2 bis which provide that “States Parties shall take measures to implement paragraphs 1, 1 bis, and 2 of this Article, including, as appropriate, adjusting their domestic legislative and/or administrative arrangements.”
The amendments also involve sharing of contacts between National IHR Authorities and WHO and this could possibly end up creating a network of regulatory authorities that could bypass political scrutiny of the WHO activities within each country relating to health emergency preparedness and response.
(iii) Accelerated information sharing from WHO to other intergovernmental organisations
Article 6 of the IHR 2005 is also amended to accelerate the speed of sharing of information from WHO to other international organisations. Until today, paragraph 1 of Article 6 has provided for immediate sharing of information with the International Atomic Energy Agency (IAEA) if the subject matter involves IAEA’s competency. In the case of other intergovernmental organisations there is no immediate sharing of information. Such organisations could get information from WHO following the triggering points available under other provisions of IHR 2005.
However, this has been amended now by modifying Article 6(1). The amended part of the Article 6(1) reads as follows:
“If the notification received by WHO involves the competency of the International Atomic Energy Agency (IAEA) or other intergovernmental organization(s), WHO shall, pursuant to paragraph 1 of Article 14, immediately notify the IAEA or, as appropriate, the other competent intergovernmental organization(s).”
(iv) Digitalization of Health Documents
Article 35 of IHR 2005 has been amended drastically to specifically provide that digital documents could also be considered as health documents and set some conditions for such documents. Newly added Paragraph 3 to Article 35 reads:
“Regardless of the format in which health documents under these Regulations have been issued, said health documents shall conform to the Annexes, referred to in Articles 36 to 39, as applicable, and their authenticity shall be ascertainable.”
Further, WHO is empowered to develop and update, as necessary, in consultation with States Parties, technical guidance, including specifications or standards related to the issuance and ascertainment of authenticity of health documents, both in digital format and non-digital format.
According to an observer of the amendment process:
“The adopted amendments are incremental steps towards enabling equity in health emergency preparedness and response. Some of them really try to address the gaps in equity as mandated in the EB Decision 150.3.
Nevertheless, the provisions still do not provide for concrete obligations on the developed countries to provide financial or technological resources to the developing countries to prepare for and respond effectively to PHEICs. What they do is entrust certain functions to WHO to enable access to such resources, especially for developing countries. If the WHO is adequately supported by the Member States in rendering these functions, then the current amendments can deliver equity.
More importantly, the amendments have also established an implementation committee which would meet periodically and can contribute towards effective implementation of the regulations”.
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