TWN Info Service on Health Issues (Mar24/05)
11 March 2024
Third World Network

WHO: Developed countries push to dilute WGIHR Bureau’s half-hearted equity text

11 March, Kochi/New Delhi (Nithin Ramakrishnan and K M Gopakumar) – Developed countries are pushing to dilute proposed equity-related text to amend the International Health Regulations (IHR) 2005.

The proposed new provisions, Article 13A and Article 44A, were tabled by the Bureau of the Working Group on Amendments to the International Health Regulations 2005 (WGIHR) at the resumed session of the 7^th meeting of the WGIHR. This took place in hybrid mode on 8 March 2024.

Article 13A deals with equitable access to health products, technologies, and know-how. Article 44A deals with the financing of IHR implementation. The resumed 7^th WGIHR was organised based on the decision of the WGIHR made on 9 February.

The original proposals for these new provisions came primarily from the Africa Group and Bangladesh, with the aim to address the equity gaps in health emergency preparedness and response.  Egypt also co-sponsored these proposals.

The 6^th WGIHR entrusted the Bureau to develop the text based on the discussions on these text proposals that took place during various WGIHR meetings. As reported earlier, the Secretariat had advised the Bureau to delete such proposals.

Sensing that this would create problems the Bureau decided not to circulate the recommendation of the Secretariat. Since the 7^th WGHIR could not discuss the Bureau’s proposed text, it was decided that the Bureau would prepare a new text and the WGIHR would hold a one-day resumed meeting to discuss the text concerned. The newly circulated Bureau’s text, however, ended up as a half-hearted proposal with several missing equity elements. It also contains loopholes which undermine the delivery of equity during health emergencies.

Nevertheless, developed countries still tried to dilute the Bureau’s text proposal further, as well as push the negotiations to the Intergovernmental Negotiating Body (INB) tasked to develop a new pandemic instrument. They continued to disregard the WGIHR's mandate arising from the WHO Executive Board Decision 150(3) to tackle equity gaps in IHR 2005. The United States, the European Union, Norway, and other developed countries attempted to dilute the entire text and find excuses to shift the provisions to the INB during the one-day resumed 7^th WGIHR.

Developing countries have stated clearly that these are 2 separate processes addressing different subject matters; INB focusses on pandemic prevention, preparedness and response, while IHR 2005 deals with all types of public health emergencies, pandemic or non-pandemic in nature.

Additionally, with the pandemic instrument being developed by the INB, there are other concerns like the ambiguity over the entry into force and the States which will eventually become parties to the instrument. Countries like Switzerland and the United States have still not ratified the Framework Convention on Tobacco Control, the only other legal instrument under Article 21 of the Constitution of WHO. Therefore, it is important to ensure equity through both instruments.                                

Bureau’s Text on Article 13A: content, gaps and the discussion

The Bureau’s text on Article 13A contains three paragraphs, with two containing several sub-paragraphs.

The first paragraph states that WHO shall support States Parties and coordinate international public health response efforts by striving to ensure equitable access to health products, technologies and know-how.

The second paragraph speaks about certain measures that will be taken up by the WHO Director-General once a public health emergency of international concern (PHEIC) is announced. These include assessing availability and affordability of the health products and technologies required to respond to the PHEIC; publishing a list of the health products along with such assessment; activating or establishing an allocation mechanism; supporting States Parties to further support scaling up and diversification of production; sharing regulatory dossiers with National Regulatory Authorities upon request; and supporting States Parties to strengthen local productions, and achieve quality assurance, and regulatory approvals etc.

The third paragraph outlines the obligations of States Parties to collaborate and support WHO-coordinated public health responses. However, the detailed actions set out in the sub-paragraphs are vague and cannot facilitate meaningful equitable access. It requires States Parties to support WHO's actions to the extent possible, engage and encourage non-state actors to contribute, and publish terms of government-funded research agreements, including pricing policies, to support equitable access.

Moreover, the third paragraph is qualified with best endeavour-type clauses such as “to the extent possible” and “in accordance with national law.” Consequently, there are no legally binding obligations in any of the provisions under paragraph 3, making the delivery of equity uncertain.

Furthermore, there are several missing links in the Bureau’s text, making the proposal for Article 13A a wool-gathering exercise. For example, it is unclear how WHO will source health products for distribution through the allocation mechanism. Similarly, while regulatory dossiers are proposed to be shared with national regulatory authorities, it is not mentioned that the dossiers will be shared with manufacturers for diversification of production during a PHEIC. It is also not clear how WHO will obtain possession of these dossiers in the first place.

Interestingly enough, States Parties are requested to publish terms of the government-funded research, but they are not required to assign rights over the outcomes of such resources to other manufacturers to diversify production.

Several other developing country proposals are not included in the Bureau’s proposed text. These include the establishment of a database for product specifications and method of processing of the required health products, and the establishment of a repository for biological starting materials such as cell-lines that are required for development and production of health products. Most importantly an obligation to share a portion of health products during PHEICs, is not explicitly mentioned in the Article 13A.

A developing country delegate told Third World Network that the discussions on loopholes in the Bureau’s text resulted in the insertion of textual suggestions by developing countries within brackets for discussion at the next WGIHR session.

When developing countries like Bangladesh, Malaysia, Iran, Indonesia, and Nigeria attempted to improve the Bureau’s text, developed countries like Norway sought to water down the equity provisions. The Africa Group and several other developing countries, including Pakistan, Brazil, Colombia, Syria, and Ethiopia, voiced out against further dilution.

Norway argued that the WHO has no capacity to ensure equitable access to health products and there is no allocation mechanism within IHR 2005. It claimed a range of stakeholders need to act in order to address the issue of equity and wanted to shift the discussion on health technologies and equitable access to the INB on a new pandemic instrument.

Though the European Union joined Norway to express concerns about the abilities of WHO to ensure equitable access or to activate allocation mechanisms, it engaged with the text and proposed a few changes and deletions.

Pakistan challenged this logic by questioning developed countries as to why they believe WHO can perform many actions for pandemics in the ongoing discussions on a pandemic instrument but doubt its ability to take similar actions for PHEICs.

Nigeria also proposed that the Director-General shall at all times cooperate with regional production centres to ensure readiness in scaling up and diversifying production.

The United States said the proposals duplicate the proposals under the INB and reserved its position on the entire text.

Monaco repeated its argument that WGIHR has no mandate to discuss these provisions pointing to the scope of IHR 2005. It neglected its own state practice of reporting on capacities for addressing access to health products under IHR 2005 for several years. For instance, Monaco has consistently marked 100 percent score in its capacity for Emergency Logistics and Supply Chain Management Systems and Mechanism under State Party Self-Assessment and Reporting Tool. The explanation of the system and mechanism under the tool explicitly covers emergency kits, protective equipment, diagnostics, medical consumables, therapeutics, drugs and biomedical equipment, beds, and stockpiles.

Germany, on the other hand, acknowledged equity is important, but at the same time proposed to delete diversification of production from the proposal.

Mexico, Botswana, China, and Malaysia however explained about the WHO’s current practices and existing mechanisms such as vaccine standardisation, international pharmacopoeia, local production and assistance units, stressing that WHO is well positioned to support Member States in the matters being discussed under Article 13A. Some of these developing countries pointed out that codification and legal backing are needed to infuse legitimacy and accountability to many of these mechanisms.

Bureau’s text on Article 44A: content, gaps and discussion

The Bureau’s text on Article 44A adopted an approach significantly different from the proposed text by the Africa Group but incorporated several ideas currently under discussion at the INB.  

A few developing countries have been pointing out that the right place for a financial mechanism serving capacity building is IHR 2005 and the new pandemic instrument can refer to the mechanism under IHR 2005 to develop additional categories to serve the specialised purposes of pandemic prevention, preparedness and response.

Although the Bureau's text proposal reflected the linkages between financing in IHR 2005 and the new pandemic instrument, it currently refers to the proposed coordinating financial mechanism within the draft negotiating text of the Pandemic Instrument to IHR 2005, i.e. it is referring to a currently non-existing instrument in an existing legal instrument, making financial assistance for IHR implementation conditional upon the entry into force of the pandemic instrument.

Further, the Bureau’s text converted the Africa Group proposal for a dedicated financial mechanism under IHR 2005 into a supplementary fund that might be used when all other existing sources, both within and outside WHO, including the coordinating financial mechanism under the INB, are exhausted. Developing countries said this is unacceptable, and they argued particularly that the coordinating financial mechanism under the INB falls short in many respects. 

The Bureau’s text on Article 44A has 6 paragraphs. The first paragraph mentions an obligation to work together to sustainably finance the full implementation of IHR 2005.

The second paragraph refers to the need for prioritising domestic finance, while the third paragraph speaks about the obligation of States Parties to collaborate to mobilise finance to support developing countries, to encourage existing financial mechanisms to be responsive to the needs and priorities of developing countries, and to support the coordinating financial mechanism being developed under the proposed pandemic instrument.

The fourth paragraph mandates the WHO Director-General to support States Parties in implementing the obligations pursuant to paragraph 3, and to report the outcomes to the World Health Assembly. 

The fifth paragraph calls for an IHR implementation fund which will provide supplementary finance to address the gaps identified in the financing of IHR implementation and the sixth paragraph discusses sources of financial resources and governance of the fund entrusted with the World Health Assembly. 

The fifth paragraph reads thus: “States Parties also agree to the establishment of, within 24 months of the adoption of this provision, a dedicated IHR Implementation Fund (“the Fund”) within the WHO, governed by and accountable to States Parties through the World Health Assembly, to provide targeted, supplementary financing in particular to developing countries, as necessary, to build, strengthen and maintain the capacities required under these Regulations. The purpose of the Fund is to address identified the gaps in financing of in IHR implementation in particular in developing countries that are not met by domestic funding, existing and new bilateral, sub-regional, regional and multilateral funding mechanisms, or the Coordinating Financial Mechanism established under the WHO Pandemic Agreement”.

Bangladesh, calling for non-debt-generative grants and funds, argued that the above fund should not be supplementary, but rather should serve the purposes of full IHR implementation and address gaps in IHR implementation that are self-identified by recipient or applicant countries.

Nigeria attempted to elevate the standard of financing obligations from "strengthening" sustainable financing to "ensuring" sustainable financing.

Malaysia, on the other hand, referred to the five-year financial strategy being developed under the proposed pandemic instrument, and recommended incorporating a similar provision in Article 44A, should the pandemic instrument fail to enter into force within a stipulated time. According to the delegation, such a strategy helps in ensuring that the donor countries align with the broad strategy developed by the WHO Member States while providing financial resources both within and outside the WHO.

Countries like Norway, Israel, Australia, U.K. and Monaco want a joint approach in financing INB and IHR.

The Africa Group at the same time is keen to see a dualistic approach to financing both instruments, according to sources.

The resumed 7^th WGIHR concluded its meeting and adopted its report. IHR States Parties are requested to provide further written inputs to the Bureau on or before 15 March 2024.+