TWN Info Service on Health Issues (Feb23/04)
20 February 2023
Third World Network

WHO: IHR Review Committee fails to make meaningful technical recommendations

Geneva, 20 February (K M Gopakumar and Nithin Ramakrishnan) – The Review Committee on Amendments to the International Health Regulations (IHR) 2005 fails to make any meaningful technical recommendations.

Its report is sending out an overall message of resisting major changes to the status quo. In other words, the Committee wants to maintain IHR 2005 as an instrument mainly focussed on information sharing on potential health emergency outbreaks and ignores the demand for equity in the Regulations. Acceptance of the recommendations of the report therefore would maintain existing inequities in the international health emergency regime.

The Review Committee (RC) was appointed with the mandate to make technical recommendations on the various IHR amendment proposals submitted by 16 Member States, under the 150^th Executive Board decision to carry out targeted amendments including equity. The Committee’s terms of reference had been criticised for their potential danger of discrediting the amendment proposals prior to the initiation of the negotiations. The report clearly affirms those apprehensions.

Using the terms of reference by the WHO Director-General and Secretariat as a pretext, the RC offers “commentary” on the Member State proposals rather than provide “technical recommendations” in accordance with their mandate under Article 50(1)(a) of IHR 2005. It must be noted that there have been IHR amendments made in the past without even constituting a review committee. According to some developing country delegates, several of the questions raised by the WHO Secretariat in the terms of reference were not even discussed during negotiations of the previous amendments.

Furthermore, most of the time, the RC ended up making remarks on the Member State proposals such as “unnecessary” – an explicit contravention of its assurance that it will not prejudice any Member State proposals. What is unfortunate here is that Member States were not given a chance to offer feedback to the Committee’s report before it was finalized.

The report consists of a preface, executive summary and four chapters. The first chapter is an introduction, and the second chapter describes the method of work. The third chapter summarises the general considerations behind the amendment proposals. The fourth chapter analyses the 300 amendment proposals and also contains the RC’s technical recommendations. This chapter contains a summary of the existing articles and corresponding amendment proposals, and the RC’s technical recommendations.

In the preface, the RC claims to have identified the values that underpin most of the proposals: (1) equity, solidarity and international cooperation, (2) trust and transparency, and (3) sovereignty. However, it is doubtful whether the Committee has really understood =these values. Most of its recommendations are inconsistent with these values or falls short of fully reflecting these values. The RC records that there is divergence among its members on several issues relating to the above values, but fails to examine whether this divergence can be substantiated on the basis of a sound technical analysis.

At the beginning of its report, the RC requires Member States to “focus on the fundamentals. Capture this unique moment of possibility. Be bold in thinking and in action. Develop and prioritize amendments to the International Health Regulations (2005) that will fundamentally improve global public health protection and help create a more equal, just and resilient world – and a better prepared one.”

However, the rest of the report shows that the RC itself was not bold enough in the thinking about equity and justice. The Euro-centric, conservative approach to duty to cooperate, dilutes all the major proposals for IHR reforms and offers a skewed view about the practicality and feasibility of such proposals. For the RC, what the international law scholars from developed country think as international law, appears as “practical and feasible”, while what the developing countries want from the IHR reforms appear as “unnecessary”. In effect the equity proposals are compromised by the RC.

The equity-related proposals mainly consist of the following areas:

• Common but Differentiated responsibility (CBDR)
• Access and Benefit Sharing (ABS)
• Equitable access
• Disciplining of unilateral actions
• Financial mechanism.

CBDR:  There are three Member States proposals to incorporate CBDR as part of Article 3 on the principles of IHR. This incorporation would then provide not only a tool for interpretation but also becomes a basis for various legal provisions on equity. The CBDR principle, by acknowledging the greater obligations of developed countries and broader policy choice for the developing countries, paves the way for burden sharing in the pursuit of the common goal of health emergency preparedness and response. It is  key to ensure “the equal, just and resilient world” which the RC calls for in its premise. However, the RC, after supporting the spirit of these proposals, sow the seeds of doubt about the applicability of CBDR in international health law.

In the report some RC members questioned the conceptual and factual application of CBDR to public health risks that may constitute a public health emergency of international concern (PHEIC). The sceptics within the RC then proceed to question whether the concept can be captured differently. However, the report does not reveal any reasons for its members’ doubts on the non-applicability of CBDR in heath emergencies.

The Committee acknowledges that “there are differences across States Parties in, among others, the level of social and economic development (e.g. small island developing States), which can influence the level of implementation of the Regulations in some circumstances”. It is interesting that it says the differences across States Parties influence implementation in “some” circumstances. Experience so far clearly shows that IHR implementation has been lagging behind in the developing world and the priorities of developed countries and donors are driving the developing countries to vertically focus more on surveillance capacities rather holistically developing their response capacities and health systems.

Out of all amendment proposals on Article 3, the RC is explicitly positive on including phrases such as “equity”, “inclusivity”, “coherence” and “solidarity” as a constructive contribution, but maintains a silence on CBDR, which has the potential to fix the existing inequity in the international health emergency regime.

The Report nonetheless notes that there exist some differentiated responsibilities in the IHR 2005 as opposed to the principle of Universal Application in paragraph 3 of Article 3. It states that “Other than rejections (Article 61), reservations (Article 62) and extensions (Articles 5 and 13), the Regulations do not explicitly provide for differentiated responsibilities of States Parties”.

Access and Benefit Sharing (ABS): There are a few proposals under Article 6 to incorporate the transfer of genetic sequence data (GSD). Some of these seek mandatory transfer of GSD, while other proposals make it contingent upon the equitable sharing of benefits.

The Committee therefore recommends that “States Parties outline a coherent, principled, efficient and pragmatic multilateral mechanism for GSD and benefit-sharing. In this regard consideration should be given to coherence with the Nagoya Protocol to the Convention on Biological Diversity which many States Parties to the International Health Regulations (2005) are parties too. The Committee also discussed the Pandemic Influenza Preparedness (PIP) Framework as an example of multilateral collaboration in this area. Furthermore, a standardization of terminology may be warranted (e.g. genomic vs. genetic sequencing data; the Committee recommends the use of “genetic sequence data”)”.

However, the RC while discussing Article 44 amendment proposals on the duty to co-operate to include sharing of samples and data make the following remarks: “The Committee acknowledges the importance of both information sharing (including biological specimens and GSD) and access to benefits derived from the use of shared pathogens. Both principles are vital but do not need to be implemented in a transactional manner”.

In the preface, where the RC offers a blueprint on the IHR amendment process, it states: “While open science is not currently part of the International Health Regulations (2005), their chief aim will be advanced with the full and open exchange of all relevant scientific information. The amended Regulations should promote open and full exchange of all relevant scientific data. The corollary to this is the equally fulsome exchange of benefits that may be derived from such data. One of these essential values should not be traded for the other.”

The RC therefore falls short in its attempt to send out the message that sharing of pathogens, genetic sequence information and benefits are equally important. The overall take of the RC on access and benefit sharing of pathogens including GSD is confusing and lacks direction. The Committee clearly fails to examine the relevance and importance of the ABS mechanism not only in ensuring equitable access to health products and technologies but also in mobilizing funds for preparedness and response. It fails to take note that benefit sharing is a concrete, measurable and objective legal obligation unlike most of the soft law obligations in IHR 2005 and other forms of duty to cooperate. ABS therefore is one of the most effective methods to create legal obligations to ensure equity – but its effectiveness comes from the linkage between “access” and “benefit sharing”. Unfortunately, the RC uses subtle language to delink access and benefit sharing.

Thus, by taking the view that access and benefit sharing should not be transactionally linked, the RC in effect aligns with the positions of the developed countries and their industries. In Chapter 2, while setting the key values underpinning the amendment proposals the RC claims that “there is convergence across proposed amendments on the sharing of GSD, with some making it conditional on having access to benefits deriving from their use”. This is clearly nudging Member States to create an obligation on sharing of pathogens and genetic sequence information – violating the principle of sovereignty of States over its genetic resources – and also inconsistent with the principle that access to genetic resources should be subject to a commitment to fairly and equitably share benefits arising from their utilization.

The RC in other words “traded off” the public interest in the concrete obligation of benefit sharing, and instead promotes the commercial interests of the pharmaceutical industries in the access and benefit sharing regime.

Equity: The RC acknowledges the need to address equity in Chapter 3 and states: “Although the term “equity” is not used in the Regulations, this value is crucial to the promotion of global health to the extent that it guides the international response to public health risks, events that may constitute a PHEIC, and a PHEIC itself”. The report also acknowledges the inequity during COVID-19 pandemic and structural barriers to access such as intellectual property rights and lack of diversified manufacturing. It is also of the view that “equity as a value and principle extends well beyond access to medical countermeasures, knowledge and technology transfer”. This pro-equity view however is not reflected in the RC’s technical recommendations on the proposals to facilitate equitable access to health products in the context of PHEIC. Equitable access proposals are reflected in a concrete way in the proposed Article 13A and Annex 10. The RC’s analysis and technical recommendations effectively rejected those proposals without even proper reasoning. For instance:

(i) Assessment of shortage: One of the proposals from the Africa Group is to create an obligation on WHO to ascertain whether there is a shortage of health products to address the PHEIC in question immediately after the declaration of PHEC. The amendment states: “Immediately after the determination of a public health emergency of international concern under Article 12, the Director-General shall make an immediate assessment of availability and affordability of required health products and make recommendations, including an allocation mechanism, to avoid any potential shortages of health products and technologies pursuant to Article 15 or 16 as appropriate”. Thus, the proposal requires the WHO to make an assessment of availability and affordability and also to develop an allocation mechanism, if there exists a potential shortage.

The RC rejects this most pragmatic approach to addressing shortage, by citing feasibility and workload of WHO during the initial stages of a health emergency. The report reads: “ the Committee recognizes the critical importance of ensuring that health products are affordable and available to every State Party. However, the requirement in paragraph 1 for the Director-General to make an “immediate assessment of availability and affordability of required health products” may not be feasible due to the magnitude of such a list implied by the proposed amendment and the very high workload imposed on WHO during the initial stages of determining a PHEIC”.

It is quite strange that the RC thinks management of accessibility of the health products required for an emergency response is a deferable function of WHO during a PHEIC. As noted by an observer, this is one of crudest reflections of colonial understanding of international health law in the report. It is indeed bewildering that the RC states that the terms “availability and affordability” are relative and complex hence required clarity, despite WHO having conducted several projects assessing both availability and affordability of medicines. There are operational definitions used in these projects which the RC may have offered as technical suggestions to Member States.

(ii) Allocation mechanism: There are at least two proposals to develop legally binding allocation mechanisms supported by more than 40 developing countries. It is clear from the proposals that an allocation mechanism is required only to address potential shortage and it is not required in the absence of a shortage. Though there was an allocation mechanism for COVID-19 vaccines, which was developed in pursuance of a World Health Assembly resolution, the majority of Member States did not follow it. This is because a multi-stakeholder institution later developed this mechanism, and the same could not be issued under the legal authority of WHO either under IHR 2005 or the WHO Constitution. This had worsened the vaccine scarcity. Thus, it is clear that in the absence of legal backing, such a mechanism does not work.

According to the RC’s report, “The Committee has concerns regarding the proposal in paragraph 1 to use Article 15 (temporary recommendations) for the purposes of establishing an “allocation mechanism.” Temporary recommendations, as defined under Article 1, are “non-binding advice and do not authorize WHO to direct States. Temporary recommendations may also be “risk-specific”, that is, individualized to areas or States with particular risk profiles. A different mode of authority may be required to establish an allocation mechanism. The Committee notes that the proposed amendment to Article 17 may be more feasible, as it requires WHO to take into account “equitable access to and distribution of medical countermeasures i.e. vaccines, therapeutics and diagnostics for optimal public health response” when issuing, modifying or terminating temporary or standing recommendations”.

The RC in this analysis completely fails to take note that an “allocation mechanism” developed in an ad hoc manner through participation of multi-stakeholder platforms which are not accountable to Member States is much worse than an allocation mechanism developed by WHO within its mandate of IHR 2005 and WHO Constitution. The RC argues that the IHR 2005 definition of temporary recommendations do not “authorize WHO to direct States”. The RC derives this inference based on its understanding of the word “non-binding advice” used in the definition. While it is true that the phrase “non-binding advice” is compromising the WHO’s ability to coordinate international public health response to PHEICs, the authority of WHO to direct States is not derived from Articles 15 and 16 (on standing recommendations).

Article 2(1)(a) of the WHO Constitution identifies WHO as the directing and coordinating authority of international health work, while Article 2(1)(g) requires WHO to stimulate   and advance work to eradicate epidemic, endemic and other diseases. Furthermore, Article 28 endorses the WHO Executive Board to take up emergency actions in this regard and the Director-General, subject to authority of the Board, may very well perform such actions under Article 31 of Constitution. Articles 12, 15 and 16 of IHR 2005 are operational reflections of this legal authority of WHO.

Moreover, the use of the word “non-binding” in Article 1 of the IHR 2005 definition of recommendations is not a bar on the States Parties to specifically identify one or more types of recommendations (if issued under Article 15) as binding by virtue of another provision. This is exactly what the Africa Group is trying to do. For instance, the Group’s proposals seek to create an obligation to comply with recommendations to facilitate availability and affordability including allocation mechanism thorough the proposed paragraphs 2 of Article 13A and 3 bis of Article 43.

The Africa Group proposal states: States Parties shall co-operate with each other and WHO to comply with such recommendations pursuant to paragraph 1 and shall take measures to ensure timely availability and affordability of required health products such as diagnostics, therapeutics, vaccines, and other medical devices required for the effective response to a public health emergency of international concern.

There are similar proposals from Bangladesh. Malaysia has also proposed to improve the effectiveness of the implementation of health measures pursuant to WHO recommendations by suggesting amendments to Article 42 of IHR 2005. Despite all these jurisdictional provisions and clear direction provided by developing countries from the Africa Group, Bangladesh and Malaysia, the RC argues that the proposal to delete the words “non-binding” will raise questions of feasibility without clearly explaining what those questions are. Deleting the adjective “non-binding” would in fact provide clarity and can avoid potential conflicts with the amendment proposals making “selected recommendations” more consequential than being merely advisory.

(iii) Guidelines for regulatory approval: Another important proposal from the Africa Group is the creation of an obligation on WHO to develop guidelines for the accelerated approvals of medical products to facilitate affordability and availability of health products. It reads: “develop appropriate regulatory guidelines for the rapid approval of health products of quality including development of immunogenicity co-relative protection (ICP) for vaccines”.

The RC rejects this proposals with the following logic: “It may be inadvisable from a legal perspective to require that WHO develops such regulatory guidelines, as the liability in the event of a significant safety flaw that appears post- marketing of the product will then fall chiefly on the Organization”. The purpose of this proposal is to accelerate the regulatory approval without compromising on safety and efficacy. That is clear from the word “quality”.  The RC’s rejection ignores the constitutional function of WHO in Article 2(w) “to develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products”. All these years WHO has issued various guidelines for the production and distribution of medicines, vaccines and biotherapeutics.

(iv) WHO Database: Bangladesh proposed a legal obligation on WHO to establish a database wherein all the required products for a PHEIC can be listed along with the specifications. Such a database would help Member States to scale up production in needy situations.  The proposal reads: “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”.

The RC recognises the utility of such database but raises doubts on the feasibility of its implementation citing that this will need additional resourcing from States Parties to WHO. The Committee then casts doubts on the proposal: “It remains unclear from this paragraph which entities would help WHO populate this database, given that much of the information called for in this database is not in the public domain but rather privately held by entities operating within States Parties…. WHO would need the help of States Parties to render this database operational, but there is no corresponding obligation on States Parties to help WHO in this regard. In that same vein, the effectiveness of such a database would be limited by the various laws and agreements that govern proprietary commercial data and patents, including the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights and domestic intellectual property laws of individual States”.

This clearly raises serious questions on the RC’s integrity in calling for open access to information. The RC when aligning with the call for an obligation to share information on genetic resources, does not see that such information is also accumulated through immense public and private investments such as ground level collection of pathogens, safe transport and undertaking of risks involved, laboratory analysis, digital capture of information etc. The RC even called for delinking access and benefit sharing, inconsistent with the Convention on Biological Diversity and its Nagoya Protocol, in order to promote rapid sharing of genetic information. However, when it comes to information regarding manufacture of products required for responding effectively to health emergencies, the RC starts to see obstacles, including the limitations posed by WTO rules and consistency thereto.

The fundamental problem seems to be lack of understanding by the RC of Member States’ proposals. Its  face-to face meetings with Member States were limited and most of them ended up as briefing sessions with one-way communications. The RC did not discuss what they think about the Member State proposals with the Member States. Even with regard to proposals which the RC felt were necessary to be clarified by Member States, the Committee sent out questions seeking clarifications via emails.

In conclusion, the RC which acknowledges “inequities in access to medical countermeasures manifested in myriad ways during pandemic”, fails not only to provide technical recommendations to improve equitable access, but also discourages the creative proposals coming from the Member States.

Disciplining of unilateral measures: Two amendment proposals on Paragraphs 4 and 6 of  Article 43 aim at disciplining unilateral measures. For this a quasi-judicial process is proposed to roll back unilateral measures without any scientific/public health backing. The RC states: “The proposed amendments in general reflect a legitimate concern to strike a better balance between implementing health measures at the national level and avoiding disproportionate and unnecessary repercussions for other States Parties. The proposals in paragraphs 4 and 6 establish a quasi-judicial process with tight deadlines and binding effects for recommendations, with the Emergency Committee having the final authority to decide on the appropriateness of health measures. This Committee is concerned that these proposals may unduly impinge on the sovereignty of States Parties and give binding effects to what are supposed to be recommendations”.

Apart from this remark the RC also applies a similar reasoning on the United States’ proposal to provide written explanation for rejecting WHO’s offer to assist under Article 13.  The fundamental fact about international law making is the acceptance of limits on sovereignty, which is a political call to be left to the Member States. Thus these comments cannot be called purely a technical recommendation. Once again, the Committee fails to see the sovereign policy space accorded under the WHO Constitution in implementing the recommendations.

Duty to Cooperate: The RC takes a very narrow view on amendment proposals on Article 44  though it “supports the affirmative idea of tangible assistance and, moreover, emphasizes that such assistance should be viewed as an act of mutual responsibility to fulfil this Article. Alternative formulations in this regard may be considered to convey this sense of partnership and mutual responsibility. Given the emphasis put on assistance in the chapeau of paragraph 1, by adding the verb “assist” and removing the qualifier “undertake to”, States Parties may wish to reflect on the desirability of retaining the existing wording of “to the extent possible” at the end of that paragraph”.

The RC’s intention is not clear as to why it wants States Parties to retain the phrase “to the extent possible” in the said provision. Does it want States Parties to demonstrate that the assistance is provided to the fullest extent possible, or it wants to allow States a discretionary choice to provide assistance or not. Even if the former is the case, the Committee then indirectly rejects the proposals to enhance the scope of WHO’s duty to cooperate. It reasons: “The numerous proposed amendments to paragraphs 2 and 3 introduce many new functions for WHO to fulfil, which would have serious implications for WHO in terms of human, financial and other resources”. Any reasonable person would have expected the technical experts in the committee to suggest creative ways of mobilizing such resources, rather than simply becoming a red flag bearer.

Financial Mechanism: An important shortcoming of the IHR is the absence of a financial mechanism to assist needy Member States and WHO to implements its provisions. To address this the Africa Group proposed a new Article 44A. Here again, though the RC recognises the need for financing, it cautions against the creation of any such mechanism: “The Committee is aware that the World Bank recently established the Financial Intermediary Fund, known now as the Pandemic Fund, to enhance financing for pandemic prevention, preparedness and response, for which WHO acts as Lead of the Technical Advisory Board, and has a role within the broader secretariat. … under Article 44, WHO already has a role, in collaboration with States Parties, to mobilize financial resources, and cautions against creating an explicit financing function for WHO under the Regulations”.

Unfortunately, while drawing the attention of Member States to the Pandemic Fund Facility managed by the World Bank, the RC ignores the shortcoming of the fund. The role of WHO is limited only to technical advice and there is no role for developing countries in the management of the fund. Participation of WHO in the broader secretariat is also not helpful as the secretariat is mandated to work in accordance with the policies of the World Bank. Further, the Pandemic Fund is not accountable to the Member States of IHR or WHO and it clearly allows donor priorities in shaping health policy choices. The RC thus ignores the long-standing history of World Bank funds that largely prioritise needs of donors and developed countries. The first call for expression of interests (EOI) for funds from the Pandemic Fund is a clear expression that the new fund is not different in this regard.

The call for EOI prioritizes health security functions such as surveillance and laboratory capacities. A State is therefore denied the opportunity to apply funds for improving health systems or its primary health care facilities, even if its health systems suffered shocks during COVID-19 response or is lacking resilience to health emergencies. It must be noted that in the IHR implementation scores for surveillance capacities stand much higher, when compared to other capacities like emergency coordination or infection control. Countries were seen scrambling for ventilators and oxygen cylinders during the COVID-19 shock. However, the World Bank’s  Pandemic Fund’s call for EOI provides no policy space for countries to apply for funds addressing such issues or any other of its priorities. A WHO fund, accountable to health assembly would not make such wrong priorities for its Member States.

Thus, the RC by cautioning against creation of WHO financial mechanism fails to consider the relevance of having a financial mechanism within IHR 2005. It will not only ensure accountability of any financial mechanism to IHR membership, but also that the WHO remains as the central authority to set health policy goals.

Overall, the technical recommendations contained in the RC report maintains the status quo of IHR 2005 which carries the colonial baggage of being a health security instrument for protecting developed countries from the diseases emerging from other parts of the world. The RC clearly reflects a thinking that urgently needs to be changed.