TWN Info Service on Health Issues (Oct22/01)
6 October 2022
Third World Network

WHO: DG aims to control IHR amendment content through IHR Review Committee

October 6, Geneva/Kochi (Nithin Ramakrishnan and K M Gopakumar) – The World Health Organization Director-General (DG) is aiming to control the content of the amendment of the International Health Regulations (IHR) 2005 through the IHR Amendments Review Committee.

The draft terms of reference (ToR) provides a wide-ranging mandate to the Committee, to even reformulate the amendments proposed by IHR States Parties.  This is inconsistent with the World Health Assembly (WHA) decision WHA 75(9) and Article 50 of IHR 2005. WHA75(9) requested the DG to convene an IHR Review Committee to make “technical recommendations on the amendments” proposed by various States Parties in accordance with the scope of Article 50(1)(a)  of IHR 2005 and to submit its report no later than 15 January 2023.

The proposed scope of work in the draft ToR for the Review Committee (RC)  allows the RC to reformulate the amendments proposed by WHO Member States, including by partially or totally removing the text proposals from Member States. Further, the draft ToR also proposes an extended timeline to submit its final report in January 2024, i.e. long after the negotiations began between Member States. Thus, there are concerns that the proposed ToR reflects the attempt to prejudge the outcome as well as process of IHR amendment.

WHA 75(9) has also invited States Parties to the IHR 2005 to submit their proposals for amending IHR 2005 before 30 September 2022. As of 30 September 2022, 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; Eswantini on behalf the WHO African Region Member States; India; Indonesia; Japan; Namibia; 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. It is learnt that a good number of developing countries’ proposals stress the importance of advancing obligations of States and the WHO for realizing equitable access to health products and technologies required for public health emergency preparedness and response.

However, the draft ToR attempts to limit such proposals being taken forward by raising leading questions as to the compatibility of the proposals with the objective and scope of IHR 2005 as well as with other international legal instruments both within and outside of WHO. Interestingly some of ToR corresponds to work in progress in other forums and documents which have no Member State consensus.

According to WHA 75.9 the RC is to function “in accordance with Part IX, Chapter III, of the International Health Regulations (2005), in particular Article 50, paragraphs 1(a) and 6, with particular attention to be paid to the fulfilment of the letter and spirit of Article 51, paragraph 2, to make technical recommendations on the proposed amendments referred to in sub-paragraph (c) below, with a view to informing the work of the WGIHR”.

[Article 50(1)(a) of IHR 2005 reads as follows: “The Director-General shall establish a Review Committee, which shall carry out the following functions: (a) make technical recommendations to the Director-General regarding amendments to these Regulations”.

Article 50(6) stipulates the selection of the RC. It reads: “The Director-General shall select the members of the Review Committee on the basis of the principles of equitable geographical representation, gender balance, a balance of experts from developed and developing countries, representation of a diversity of scientific opinion, approaches and practical experience in various parts of the world, and an appropriate interdisciplinary balance”.

Article 51(2) requires that “The Director-General shall invite Member States, the United Nations and its specialized agencies and other relevant intergovernmental organizations or nongovernmental organizations in official relations with WHO to designate representatives to attend the Committee sessions. Such representatives may submit memoranda and, with the consent of the Chairperson, make statements on the subjects under discussion. They shall not have the right to vote”.]

Accordingly, the WHO DG will be convening IHR RC on 6 October 2022. The list of members of the RC will only be published after its first meeting. It will be a “closed virtual meeting to elect Chair, Vice-Chair, and Rapporteur of the IHR Amendments RC, and define the Methods of Work”.

Draft TOR: RC to do much more than providing “technical recommendations”

 

The proposed scope of work in the ToR contains the following four elements:

(1)   Analysis of each of the proposed amendments to the IHR submitted no later than 30 September 2022;

(2)   Proposals for reformulation and/or clarification;

(3)   Analysis of the remaining provisions of the IHR;

(4)   Overall consistency analysis, including of definition of terms.

The text explaining the four elements is as follows:

“i.        Analysis of each of the proposed amendments to the IHR submitted no later than   30 September 2022 in terms of:

                                         

-          Consistency across proposed amendments in case multiple proposals are submitted to the same article;

-          Pertinence vis-à-vis the purpose and scope of the IHR, as defined in Article 2;

-          Pertinence vis-à-vis the article intended to be amended;

-          Consistency with the Constitution of WHO;

-          Consistency, where applicable, with other provisions contained in the article intended to be amended;

-          Consistency with any other provisions of the IHR;

-          Compatibility and consistency with provisions of other relevant WHO frameworks and relevant international legal instruments under the auspices of other intergovernmental and international organizations, such as:

▪           the Pandemic Influenza Preparedness (PIP) Framework;

▪           the International Food Safety Authorities Network (INFOSAN,        under the auspice of the Food and Agriculture Organization    (FAO) and WHO);

▪           the WHO Global Surveillance and Monitoring System for    substandard and falsified medical products (GSMS);

▪           Convention on Biological Diversity (CBD), relevant legal   instruments of the following UN agencies: International Atomic            Energy Agency (IAEA), International Civil Aviation    Organization (ICAO), International Maritime Organization   (IMO), Organization for the Prohibition of Chemical Weapons             (OPCW), United Nations Human Rights Council (HRC), United      Nations Office for Disarmament Affairs (UNODA), World     Organization for Animal Health (OIE), World Trade    Organization (WTO);

-          Compatibility and consistency with the Working Draft of a WHO Convention, Agreement, or other International Instrument on Pandemic Prevention, Preparedness and Response (Document A/INB/2/3).

ii.         Proposals for reformulation and/or clarification; e.g., rewording, rephrasing, inclusion of cross-references to other relevant articles of the IHR, inclusion of compliance monitoring elements – and/or consolidation, if/when necessary, of the text of the article intended to be amended, as well as of the text of any other article of the Regulations that needs amendments for the article intended to be amended to be applicable. Such proposals shall ensure the internal consistency, integrity, and robustness of the text of the IHR, as well as the compatibility and consistency with any other relevant international legal instrument under the auspices of intergovernmental and international organizations. Each of the above-mentioned proposals for reformulation and/or refinement by the IHR Amendments RC shall be accompanied by its rationale, including the reason/s why amendments proposed by States Parties have not been totally or partially retained, or have been reallocated to an article different from the one initially intended to be amended.

iii.        Analysis of the remaining provisions of the IHR: for provisions that were not subject to proposals for amendments – to identify internal inconsistencies, inconsistencies vis-à-vis other international legal instruments

iv.        Overall consistency analysis, including of definition of terms:  to advise on definitions of terms, either new or existing terms the meaning of which might be changed following the proposed amendments, to ensure clarity and consistency; as well as to advise on whether the inclusion, in the text of the IHR, of an explicit taxonomy related to the nature of amendments (e.g., targeted amendments, conforming amendments, technical adjustments, updates, “reopening the instrument”) is warranted and, if so, to formulate a proposal in that respect.”

Thus, the draft ToR proposes a clear mandate to RC to not only examine the proposed amendments technically but also to undertake “reformulation and/or clarification; e.g., rewording, rephrasing, inclusion of cross-references to other relevant articles of the IHR”. This goes beyond the mandate of the WHA Decision 75(9). Further it says: “Each of the above-mentioned proposals for reformulation and/or refinement by the IHR Amendments RC shall be accompanied by its rationale, including the reason/s why amendments proposed by States Parties have not been totally or partially retained.”

If the draft ToR is accepted the RC could can reformulate the amendment proposals of the Member States. It can even partially or totally remove Member States’ text proposals from the negotiating table in the Working Group on IHR amendments (WGIHR). This effectively creates a situation wherein only those proposals that pass the RC’s scrutiny could be discussed within the WGIHR. The draft ToR therefore definitely goes beyond the common understanding of the word “technical recommendations” used in Article 50(1)(a). Moreover, the power imbalances between developed and developing country Member States would most likely influence this decision making about which proposals need to be on the negotiating table and how.

[The Member States Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (WGPR) was renamed WGIHR to undertake the work on IHR 2005 amendments.]

The draft ToR also undermines the Member State-led process of IHR amendment and even infringes the sovereign right of a IHR State Party to propose amendments. According to Article 55, which deals with amendments: “Amendments to these Regulations may be proposed by any State Party or by the Director- General. Such proposals for amendments shall be submitted to the Health Assembly for its consideration.” There is no requirement under IHR 2005 that the amendments proposed by any State Party should be submitted to the scrutiny of the RC.

In addition, WHA 75 adopted part of the amendment proposals from the USA without the scrutiny of the RC. The WHA decision 75(9), as mentioned above, also does not provide any mandate to RC other than making “technical recommendations”.  

Prejudging scope of amendment and limiting Member States’ prerogative

According to the draft ToR, the RC is to examine the amendment proposal’s “Pertinence vis-à-vis the purpose and scope of the IHR, as defined in Article 2 as well as Pertinence vis-à-vis the article intended to be amended” among other things.

This is under the presumption that there will not be any State Party proposal to change or expand the scope and objective of the IHR 2005. It was learned that a few proposals from Member States’ proposed amendments to Article 2, which contains the purpose and scope of IHR. Also, it limits the freedom to States Parties to change the status quo and propose amendments which expand or alter the scope of current IHR articles.

The draft ToR further proposes the RC to analyse the compatibility and consistency with provisions of other relevant WHO frameworks and relevant international legal instruments under the auspices of other intergovernmental and international organisations. It also invites to study “the compatibility and consistency with the Working Draft of a WHO Convention, Agreement, or other International Instrument on Pandemic Prevention, Preparedness and Response (Document A/INB/2/3)”.

While the former gives a presumption that IHR 2005 in its amended version should not seek to alter the impact of the existing legal instruments, the later seeks to limit the IHR amendment process by referring to a working document which does not have Member State consensus.

Further, it must be noted that Document “A/INB/2/3” is not even a negotiated document and there is no Member State consensus on the contents in the working draft of a new pandemic instrument contained in the said document. It is only a compilation of ideas by the Intergovernmental Negotiating Body (INB) Bureau and WHO Secretariat. It is not even a Zero Conceptual Draft for the new pandemic instrument. Member States have only submitted their comments to A/INB/2/3 and these are being studied by the INB Bureau and an advance copy of the Zero Conceptual Draft will only be released in the month of November.

The INB will have to convene its 3rd session in the second week of December and see whether the Zero Conceptual Draft gets consensus or not. It is also noteworthy that the scope of the proposed instrument under document A/INB /2/3 is limited to pandemics and does not cover all types of Public Health Emergency of International Concern (PHEIC) as is covered by the IHR 2005.

It is important to note that the mandate of the RC is only to provide technical recommendations does not include  the mandate to coordinate with INB. Coordination with the INB is left to the WGIHR. According to the WHA Special Session 2 decision, the INB is to take into account the discussions of WGPR which is renamed as WGIHR. The relevant part of the decision reads: “… that the process referred to in paragraph (3) should be informed by evidence and should  take into account the discussions and outcomes of the Member States Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (WGPR), considering the need for coherence and complementarity between the process of developing the new instrument and the ongoing work under resolution WHA74.7, particularly with regard to implementation and strengthening of the IHR (2005)”;

While consistency with existing legal instruments is a good characteristic of any new legal reform, it cannot limit the freedom for States Parties to move away from pre-existing law if needed. It is against the basic principles of international treaty making, which allows States to develop subsequent treaties which may be different from then existing treaties. For instance, the Vienna Convention on the Law of Treaties, which reflects the application of lex posterior derogat legi priori (later law supersedes the earlier law) and the International Law Commission, which discusses this principle elaborately in its extensive study report and conclusions on the fragmentation of international law, have made no remark that limits the freedom of States to enter into two or more incompatible treaties.

On the other hand, the reformulation of the text proposals by the RC is mandated to be consistent and compatible with existing international legal instruments.

Draft ToR prolongs the duration of RC

According to WHA75(9) Paragraph 2(e) the RC is requested to “submit its report to the Director-General no later than 15 January 2023, with the Director-General communicating it without delay to the WGIHR”. Thus, there is no mandate for the RC beyond 15 January 2023. To the contrary, the draft ToR sets a much later deadline of January 2024 before the package of amendment proposals is forwarded to the WGIHR.  The RC reports if such a process is allowed, can influence the negotiations within WGIHR and frustrate the freedom of Member States to negotiate.

Further, the timeline collides with pressures of the Executive Board meeting that precedes WHA77. Therefore, this attempt has neither legal backing, nor is a legitimate move in supporting a Member State process for amending IHR 2005.

Silence on the mandate of EB150(3) and WGPR Final Report

The 150^th meeting of the Executive Board adopted the decision to amend IHR. Paragraph 2(a) of decision EB150(3) sets the scope of the IHR amendment, which explicitly states that the Amendments should “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.”

Nevertheless, the draft ToR, does not require the RC to look at the compatibility/relevance of IHR amendment proposals with this mandate of EB150(3). On the other hand, the draft ToR is also enabling the IHR Review Committee to define “targeted amendments” which is a phrase used in the decision to WHA75(9) to refer to the potential amendments as identified by Member States in EB150.

EB150(3) clearly defines the scope of the proposed amendments in the paragraph 2(a) quoted above. No expert committee can have the authority to interpret what the Member States meant by this phrase in the decision of WHA75(9). This is another attempt to create new filters to limit the amendment proposals.

Much worse is the case with the WGPR final report, which is the outcome of deliberations of the Member States over the recommendations and suggestions made by three important expert committees which studied the functioning of WHO, Member States and existing legal instrument, i.e. IHR 2005, during the COVID-19 Response. The Final Report of the WGPR could serve as a check-point for analysing whether the proposals for IHR amendment are in the right direction as envisaged by the Member States. Unfortunately, the draft ToR does not make any reference to it.

WHO Secretariat is behind the idea of RC

The decision to have an IHR Review Committee looking at the amendment proposals by States Parties was a WHO Secretariat idea during the WGPR meetings in May 2022. Such a proposal by the WHO Secretariat was unusual as there has already been an IHR review committee which looked at COVID-19 Pandemic Response that made technical recommendations as to what needs to be changed in the functioning of the WHO and Member States as well as IHR.

Article 50(1)(a) was intended to support the DG, if he intends to make a proposal for amending IHR 2005 under Article 55(1). Article 50(1)(a) could have never been envisaged as an expert committee appointed by an international civil servant making remarks on the text proposals made by States Parties.

The previous amendments to IHR 2005 did not have an intervention by the RC as envisaged by this current draft ToR. It must be noted that the WHO Secretariat is in the forefront of promoting a new legal instrument in the WHO, which is seen by many as a competing process against the IHR amendment process.

Amidist the negotiations in the WGPR and WHA75, the developed countries were making clear attempts to use the IHR amendment process to advance more obligations on information sharing and surveillance without making any corresponding obligations on finance and resources for the health emergency preparedness and response of developing countries. Further there was no willingness on their part to address the issue of equitable access to health products required for health emergency response. The only promise from the developed countries like those from the European Union was to address equity in the context of pandemics (not all types of health emergencies) and that too only in the new instrument.

The draft ToR developed by WHO DG shows all the potential signs that the RC could be used by vested interests to delegitimize the proposals from developing countries to amend IHR 2005, especially those requiring equitable access to health products and technologies for addressing the PHEIC.