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TWN Info Service on Health Issues
22 April 2024
Third World Network
www.twn.my
WHO: WGIHR Bureau’s text recognises equity without effective implementation means
Geneva, 22 April (K M Gopakumar) – A consolidated text on proposals to amend the International Health Regulations (IHR) 2005 recognises the promotion of equity and solidarity as a principle of IHR implementation but undermines it with the absence of effective means of implementation.
The text was produced by the Bureau of the Working Group on Amendments to the International Health Regulations 2005 (WGIHR), hereby referred to as “the Bureau’s text”.
The Bureau’s proposals undermine equity by placing the responsibility of financial investment on State Parties without considering the existing development divide among WHO Member States.
The Bureau’s text is to be discussed during the 8th meeting of the WGIHR which will take place on 22-26 April at the WHO Headquarters in Geneva in a hybrid mode.
Though the Co-Chairs and WGIHR Bureau have previously prepared text of specific Articles this is the first time the Bureau developed a consolidated text. This is a practice imported from the Bureau of the Intergovernmental Negotiating Body (INB) on a pandemic instrument, which is currently under criticism for undermining the textual proposals of Member States, especially developing countries.
The consolidated text removes all the textual proposals of Member States and proposes amendments to around 25 articles including the Article dealing with definitions as well as annexes. The substantial amendments are confined only to a few Articles and Annex 1.
The Bureau proposes to amend Paragraph 1 of Article 3 as follows: “The implementation of these Regulations shall be with full respect for the dignity, human rights and fundamental freedoms of persons, and shall promote equity and solidarity among States Parties”.
An accompanying document on the rationale of the Bureau’s proposal explains the inclusion of equity in Paragraph 1 by citing the Technical Recommendation of the Review Committee on Amendments to the International Health Regulations (2005):
“The Committee also notes that, as referred to in the proposed amendment to paragraph 1 and new paragraph 5, inclusivity, coherence and particularly equity and solidarity are important principles underpinning the Regulations, and also reflect important lessons from the COVID-19 pandemic”.
One of the important shortcomings of IHR 2005 is the absence of equity, reducing it to an instrument to provide information on disease outbreaks with potential to become a Public Health Emergency of International Concern (PHEIC) without any legal guarantee to obtain assistance for effective response. Though there is recognition of the need for assistance for IHR State Parties, especially developing countries, there are no provisions to translate this into reality, particularly into assistance to facilitate access to health products required for PHEIC preparation and prevention. Therefore, the WHO Executive Board (EB) decision 150.3, which sets the scope of the IHR amendment, provides a clear mandate to address equity.
EB 150.3 states:
“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.”
The Bureau dropped the principle of common but differentiated responsibilities (CBDR) by citing the differing views on its inclusion among the Member States.
Equitable Access
The Bureau’s text recognises the need for equitable access for effective PHEIC response. In this regard, the text proposes an amendment to the title of Article 13 on public health response, by adding the phrase “including access to health products”. The proposed title now reads: “Public health response, including access to health products”.
Further, the text proposes 3 more paragraphs to Article 13 viz 7, 8 and 9. The rationale for the inclusion of the 3 new paragraphs is to merge some of the ideas proposed as Article 13A by Bangladesh and the Africa Group. The rationale document of the Bureau states:
“The proposed new Paragraphs intend to operationalize the principles of equity and solidarity that the Bureau proposes to include in Article 2. They focus on the critical role of health products, and, where applicable, technology transfer, in response efforts.”
The proposed Paragraph 7 of Article 13 obligates WHO to support and coordinate response activities during PHEIC and pandemic emergencies. Among the supporting activities is facilitating equitable access through equitable allocation and distribution of health products, including through technology transfer. It reads:
“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”.
Paragraph 8 proposes to obligate the Director-General of WHO to take the following measures after the determination of PHEIC to facilitate equitable access:
- To conduct and periodically review and update, an assessment of the availability and affordability of health products needed for the public health response and consider the assessment while making recommendations under Articles 15, 17, 18 and 49;
- To make use of existing or new WHO-coordinated allocation mechanism(s) to assist States Parties to access relevant health products based on public health risks and needs;
- To support efforts by States Parties to scale-up and diversify, as appropriate, the production of relevant health products;
- To facilitate the sharing of dossiers with the consent of manufacturers for the purpose of facilitating regulatory authorization by the National Regulatory Authority;
- To support States Parties, to strengthen local production including technology transfer on mutually agreed terms.
The Bureau’s rationale behind Paragraph 8 is as follows: “Through the proposed New Paragraph 8, the Bureau intends to introduce more specific obligations than those detailed in the proposed New Paragraph 7, for the WHO Secretariat to ensure equitable access”. Further, it cites various World Health Assembly resolutions and ongoing WHO programs to show the existing mandate and rationale behind its proposals under Paragraph 8.
Paragraph 9 proposes obligations on State Parties to cooperate among themselves to the fullest extent possible as per their national law and available resources, to collaborate with WHO and other State Parties to support WHO-coordinated response activities. These include:
- supporting WHO in implementing actions outlined in paragraph 8 of [Article 13];
- To engage and encourage non-state actors to contribute towards equitable access to health products needed to respond to a public health emergency of international concern;
- To maintain transparency by publishing relevant terms of government-funded research agreements for PHEIC health products such as pricing policies regarding these products and technologies, to support equitable access.
According to the Bureau “…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”.
Further, the Bureau’s text proposes the inclusion of “availability of, and accessibility to, relevant health products” under Article 17 as one of the criteria for making recommendations.
It also proposes an obligation on State Parties to take all practical steps while taking additional measures under Article 43 to facilitate access to health products to other countries. It reads:
“When implementing additional health measures referred to in paragraph 1 of this Article, States Parties shall take all practicable measures to facilitate other States Parties in accessing health products relevant for responding to a public health risk or a public health emergency of international concern”.
Another relevant proposal on equitable access in the Bureau’s text relates to Article 44 dealing with collaboration and alliance. The Bureau proposes to include the facilitation of access to health products, including through WHO-coordinated mechanisms, as an area of collaboration and assistance. Similarly, the Bureau’s text also proposes “facilitating equitable access to health products through WHO-coordinated mechanisms” as an area of collaboration between WHO and Member States.
However, these proposals especially those under Article 13 lack effective means of implementation. They do not provide any direction or indication on how the WHO Secretariat and Director-General are to facilitate equitable access.
For instance, Bureau’s proposal on Article 13.7 states: “… 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.”. Similarly, Article 13.8. (e) states: “support States Parties, upon their request, to strengthen local production; achieve quality assurance through regulatory approval of locally manufactured products; and facilitate research and development and technology transfer on mutually agreed terms”.
However, there is no indication of the means to achieve this. In the absence of such direction, it gives enough room to WHO and the Director-General to bypass accountability on this important issue.
There is also lack of clarity on the trigger for activities mentioned under the proposed Article 13.8. Following the chapeau of Paragraph 8 that reads “After the determination of a public health emergency of international concern, pursuant to Article 12 of these Regulations, the Director-General shall…” there is a list of 4 actions by the Director-General of WHO. This implies that the WHO Director-General has to take those measures which include supporting States Parties, upon their request, to strengthen local production only after the determination of PHEIC. That would be too late to act. Support for local production and equitable access should be an ongoing mandate and its trigger should not be limited to the determination of PHEIC.
While framing these proposals the Bureau has ignored the specific proposals made jointly by the Africa Group and Bangladesh to facilitate technology transfer. For instance, Bangladesh made the following proposal:
“WHO shall develop and maintain a database containing details of the ingredients, components, design, know-how, manufacturing process, or any other information required to facilitate manufacturing of health products required for responding to the potential public health emergencies of international concern. Within two years of the entry into force of this provision, WHO shall develop this database for all PHEICs declared so far, including for the diseases identified in the IHR 1969”.
Similarly, the Africa Group proposed to facilitate local production of health products required for PHEIC, as follows:
“WHO shall take measures to ensure availability and accessibility through the local production of required health products including:
a) develop and publish a list of required health products,
b) develop and publish specifications for the production of required health products,
c) develop appropriate regulatory guidelines for the rapid approval of health products of quality including development of immunogenicity co-relative protection (ICP) for vaccines,
d) establish a database of raw materials and their potential suppliers,
e) establish a repository for cell-lines to accelerate the production and regulatory of similar biotherapeutics products and vaccines,
f) review and regularly update WHO Listed Authorities so as to facilitate appropriate regulatory approvals”.
Further, the Bureau’s proposals on equitable access under Articles 13.8 and 9 as well as in Article 44 are marred with multiple qualifications. This would seriously undermine the effective implementation of equity.
Moreover, a proposal of the Bureau to add a footnote to Annex 6 (on vaccination, prophylaxis and related certificates) effectively neutralises equitable access especially through local production. Paragraph 3 of Annex 6 states “Certificates under this Annex are valid only if the vaccine or prophylaxis used has been approved by WHO”. The proposed footnote to this Para now states:
“Approved by WHO refers to health products evaluated and listed by WHO under the WHO Prequalification (PQ) procedures, applicable to medicines, vaccines, in-vitro diagnostics, vector control products, immunisation devices; and inspection services; and Emergence Use Listing (EUL) procedures, applicable to medicines, vaccines, in-vitro diagnostics”.
A similar footnote is also proposed to the model international vaccination and prophylaxis certificate, which is part of Annex 6. This means that vaccination, prophylaxis or related certificate under the IHR will be recognised for international travel and related purpose only when the product used is prequalified by WHO.
This restricts the number of products which can be used for diagnosis, vaccination, and treatment. The insistence of WHO pre-qualified products would result in concentration and monopoly. Further, the compliance cost of WHO pre-qualification is high and only a few manufacturers from developing countries can meet the WHO pre-qualification standards. The WHO pre-qualification process also systematically discriminates against the regulatory approval by developing country manufacturers. As per the current practice, it is almost an automatic approval for products approved by WHO Listed authorities formerly known as stringent regulatory authorities. If an independent WHO evaluation is required for products approved by regulatory authorities, this would require time and resources.
A recent report of the US International Trade Commission (ITC) observes that prequalification is expensive and delays access. It states:
“These procurement agencies, however, rely on WHO prequalification (or emergency use listing) and guidance issuance for all tests and treatments, which were reported to have caused delays. In the case of some therapeutics, such as remdesivir, WHO recommendation and prequalification came a full two years after U.S. authorization and the first VLs (voluntary licences) were signed. This means that although treatments were available, many countries were not immediately able to access them. WHO prequalification, which is also required for certain MPP (Medicines Patent Pool) sublicensing agreements, requires significant effort by manufacturers in order to complete the application requirements and address data standards, which may be challenging for some manufacturers. It can also be costly. As noted in chapter 2, a one-time application fee of $25,000 is required in addition to a $20,000 annual fee for a full product assessment. Industry representatives have noted that these fees may be too expensive for smaller manufacturers in many LMICs”.
Similarly, the External Evaluation of WHO’s Access to COVID-19 Tools (ACT) Accelerator or ACT-A observes: “Access to certain diagnostic types was delayed due to late WHO clearance (especially for self-tests). Diagnostics are usually less complex to develop than drugs and vaccines. They are very important throughout the pandemic, especially at the beginning of pandemics when other MCMs (medical counter measures) are not available”.
The Bureau provided following comment for the footnote without examining the implications of its suggestion: “The Bureau notes the diverse positions of Member States with respect to the term “approval” (“subject to its approval” in Paragraph 1, “approved by WHO” in Paragraph 3 and the first paragraph following the table in the Model ICVP) and its possible replacement with the terms “prequalification and emergency use listing”.
Finance
The Bureau’s text on finance for the implementation of IHR 2005 follows the proposal of the INB Bureau of the pandemic instrument and dropped the Africa Group proposal on the creation of a dedicated fund. Instead, it proposes to use the fund to be created under the pandemic instrument. The proposal states: “… secure the financial resources necessary to support the implementation of these Regulations through coordination and/or funding mechanisms that may be established in future International Agreement(s) related to pandemic prevention, preparedness and response”. However, the latest INB Bureau’s text on the pandemic instrument does not contain any proposal to create a fund.
Further, the Bureau proposes to explore the idea of the creation of funds at a future date. The proposal in this regard states: “… review the effectiveness of the provisions in this paragraph two years from their entry into force, and address identified gaps in financing IHR implementation that are not being met by current or future domestic funding, existing and new bilateral, sub-regional, regional and multilateral funding mechanisms, including, if necessary, through the establishment of a dedicated financing mechanism to provide targeted, supplementary financing, in particular to developing countries, to build, strengthen and maintain the capacities required under these Regulations.”
Instead of offering a solution to the lack of predictable and sustainable financial resources for the implementation of IHR the Bureau’s text shifts the burden to State Parties to make the required investment for the implementation especially to achieve core capacities mentioned under Annex 1. It proposes the creation of national IHR Authorities under Article 4 and puts the responsibility of implementation solely onto State Parties without offering any assistance.
A new Paragraph 2bis is proposed to Article 4 and it states: “States Parties shall take measures to implement paragraphs 1, 1 bis, and 2 of this Article, including, as appropriate, by allocating human and financial resources, as well as by adjusting their domestic legislative and administrative arrangements”.
Similarly, a proposed new Para 1bis of Article 13 reads: “Each State Party shall, within the means and resources at its disposal, provide sustainable domestic funding to build, strengthen and maintain the core capacities required under these Regulations”. This creates a burden of proof on countries seeking assistance for the implementation of IHR core capacities under IHR to prove that it has already exhausted domestic funding within the means and resources at its disposal. This proposal would institutionalise the development-blind approach to IHR implementation and a departure from the Bureau’s proposal in Article 3 i.e. the implementation of IHR 2005 shall promote equity and solidarity among States Parties.
However, the rationale provided by the Bureau is silent on the implications of this proposal. It only states that it simply shifted a proposal that obtained wide support during the discussions on Article 44. The rationale of the Bureau states: “This paragraph is an updated Bureau proposal based on Paragraph 2 of the Bureau’s proposal for Article 44A, related to domestic financing for IHR implementation, which received good support during the discussion at WGIHR7. The Bureau proposes to move this paragraph to Article 13 alongside other domestic obligations, as the Bureau considers this is a more appropriate place for such a provision, rather than as part of Article 44, which relates to collaboration between States Parties’.
However, the fact is that there was no amendment proposal to Article 44 submitted by any Member State proposing such language.
Further, this proposal is to promote the new co-funding model, an approach to legitimise the abdication of the responsibility of developed countries to provide financial resources to address global concerns such as health emergency preparedness and preparation.
Access and Benefit Sharing (ABS)
The Bureau’s text fully ignores the sharing proposal made by the Africa Group.
The Africa Group had proposed the insertion of the following paragraph to Article 6 of IHR 2005:
“No sharing of genetic sequence data or information shall be required under these Regulations. The sharing of genetic sequence data or information shall only be considered after an effective and transparent access and benefit sharing mechanism with standard material transfer agreements governing access to and use of biological material including genetic sequence data or information relating to such materials as well as fair and equitable sharing of benefits arising from their utilization is agreed to by WHO Member States, is operational and effective in delivering fair and equitable benefit sharing”.
The absence of a fair and equitable benefit-sharing mechanism under IHR 2005 undermines equity by giving a free-riding possibility to pharmaceutical companies especially those based in developed countries to make use of the pathogen samples or their sequence information without any corresponding obligation to share the benefits emanating from their research and development. Though there was discussion to include the Pandemic Access and Benefit Sharing (PABS) system to include benefit sharing during PHEIC the latest INB Bureau’s text limits the benefit sharing only to the duration of the outbreak of a pandemic. This means there would not be any obligation to share benefits by contributing health products during a PHEIC. This goes against the mandate of addressing equity under decision EB 150.3.
It is clear that though the WGIHR Bureau recognises equity as a principle under Article 3 of IHR 2005 the Bureau’s text requires further amendment and clarifications to operationalise equity into concrete deliverables.
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