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Info Service on Health Issues (Jul23/04) WHO: North’s proposals to take centre stage in IHR working group meeting 24 July, Geneva (TWN) – The fourth meeting of the Working Group on Amendments to the International Health Regulations (WGIHR4) is to discuss various developed country amendment proposals focusing on accelerated information sharing and compliance. These proposals are from the USA, the European Union (EU), Switzerland and New Zealand. WGIHR4 will take place at the WHO Headquarters in Geneva on 24-28 July in a hybrid mode. According to the WGIHR4 draft program of work, amendment proposals to the following articles will be considered: ● Responsible authorities – Article 4 ● Notification, verification, and provision of information – Article 5 (paragraph 4 and new paragraph 5). Articles 6–11, Annex 2 and new Annex 2 as an alternative ● The Emergency Committee – Articles 48 and 49 ● Determination of a public health emergency of international concern – Article 12 ● Temporary and standing recommendations – Articles 15–18. The third meeting of WGIHR had focussed on amendment proposals on Article 13 (public health response), new article 13 A (equitable access to health products, technologies and know-how), 43 (additional health measures), 44 (collaboration and cooperation), new article 44A (financing mechanism), New Article 53A (implementation and compliance). This week the majority of the amendment proposals under consideration are from developed countries. Many of these aim at enhancing the obligations on information sharing and compliance that on the surface seem reasonable but can be negative for developing countries. It is noteworthy that none of the developed country proposals focus on equitable access to medical products (such as diagnostics, medicines, vaccines or therapeutics) required for preparedness and response to public health emergencies of international concern. Some of these proposals raise issues of concern as follows: ● Creating obligations to have a vertical approach on emergencies; ● Classifying emergencies of international concern into national, regional and global risks, thereby abdicating from international responsibilities; ● Creating obligations on States Parties and WHO to share more information including genetic sequence data; ● Reducing policy space and discretion of States Parties in the name of accountability and time constraints, including in sharing of information obligations; ● Making available, the information shared with WHO, to other agencies, including international organizations like IAEA, FAO, WTO, international financial institutions and to all States Parties and their national entities; ● Empowering WHO to take actions without consulting with affected States Parties. Responsible Authorities (Article 4) There are five amendment proposals under this article. Two of them are from Russia and another two from Switzerland. The fifth amendment proposal is from the Africa Group that obligates WHO to provide technical assistance to National Focal Points. The first Russian proposal seeks to designate or establish an “entity” as the IHR Focal Point. Under the current provision each State Party shall either designate or establish a National IHR Focal Point. The proposal aims to change the current obligation from the designation or establishment of an “entity” as National IHR Focal Point to the creation of an independent or separate institution as IHR Focal Point. The second proposal from Russia aims to provide legal authority to the National IHR Focal Point and reads: “States Parties shall / ALT may enact or adapt legislation to provide National IHR Focal Points with the authority and resources to perform their functions, clearly defining the tasks and function of then entity with a role of National IHR Focal Point in implementing the obligations under these Regulations”. Switzerland’s first proposal also requires the States Parties to establish a National Competent Authority responsible for IHR implementation. It states: “In addition, each State Party should inform WHO about the establishment of its National Competent Authority responsible for overall implementation of the IHR that will be recognized and held accountable for the NFP’s functionality and the delivery of other IHR obligations.” The second Swiss proposal seeks to create an obligation on States Parties to provide the contact details of National Competent Authorities (replacing the current National IHR Focal Points) to WHO. These four amendment proposals aim to create independent authorities in charge of IHR implementation and to convert the current National IHR Focal Point into a larger free-standing institution. This could result in creating silos in the health system by taking away the emergency preparedness and response functions from the authority in charge of health system administration. Such an approach may result in the flow of international assistance directly to such IHR authorities, limiting the resources available for strengthening broader health systems. The health system is the backbone of a broad emergency response system and in the absence of health system resilience, emergency preparedness and response will be compromised. Further, it would result in the fragmentation and duplication of scare domestic health finance. It is interesting to note that the Swiss proposal is not accompanied by any proposals on technical and financial assistance to implement IHR in developing countries. Creation of such authorities at the national level and adoption of national legislations may also lead to the harmonisation of health emergency preparedness and actions, constraining the policy space for States Parties, through international networks, as happened in the case of networks of economic regulators. Thus, these proposals bear the danger of verticalization of health emergency preparedness and response work at the national level and of fragmenting the health system. Surveillance (Article 5) Since WGIHR3 had discussed amendment proposals on Paragraphs 1, 2 and 3 of Article 5, WGIHR4 will discuss amendment proposals on Paragraph 4, including a new proposed paragraph and 3 other amendment proposals for a new Paragraph 5. The USA proposes a new Paragraph 5, which reads: “WHO shall develop early warning criteria for assessing and progressively updating the national, regional, or global risk posed by an event of unknown causes or sources and shall convey this risk assessment to States Parties in accordance with Articles 11 and 45 where appropriate. The risk assessment shall indicate, based on the best available knowledge, the level of risk of potential spread and risks of potential serious public health impacts, based on assessed infectiousness and severity of the illness”. This proposal alters IHR’s approach to risk assessment and divides it into national, regional and global levels. The proposed USA approach is followed up with the amendment proposals to declare a public health emergency of regional concern and intermediate health alert under Article 12. [Article 12 deals with the declaration of a public health emergency of international concern (PHEIC).] This type of grading of emergencies based on the geographical spread provides a justification for the developed countries to abdicate from their responsibilities in international/global health by classifying an emergency as regional. Further, this kind of approach may keep certain regions under a health emergency for a long time with adverse implications for trade and travel. Notifications (Article 6) The USA proposes an amendment to Paragraph 1 of Article 6 which obligates States Parties to complete the assessment of a public health event within 48 hours using the decision instrument included in Annex 2. This proposal overlooks the asymmetries existing in terms of technical and resource capabilities among States Parties. Like Switzerland, the USA is also not offering any assistance to comply with such obligations. It must be also noted that States Parties already have an obligation to develop capacities to conduct the assessment of all urgent events within 48 hours under the existing Annex 1. As such the USA proposal is redundant. Further, the USA also proposes an amendment to the last sentence of Paragraph 1, which currently obligates WHO to notify the International Atomic Energy Agency (IAEA) if the notification from the State Party falls within the competency of the Agency. The proposal expands the scope of that obligation to include FAO, World Organization for Animal Health (OIE), UNEP and other relevant entities. This proposal thus brings the One Health approach to IHR without directly mentioning it. Such wide sharing of information with these organisations even before assessing the information shared by State Parties scientifically, bears the risk of adverse economic implications for the affected countries. In Paragraph 2, the USA and EU propose to create sharing genetic sequence data as part of the obligation to share public health information. Currently the scope of public health information includes “case definitions, laboratory results, source and type of the risk, number of cases and deaths, conditions affecting the spread of the disease and the health measures employed; and report, when necessary, the difficulties faced and support needed in responding to the potential public health emergency of international concern”. The EU’s proposal goes even beyond genetic sequence data as follows: “… epidemiological and clinical data, as well as microbial and genomic data in case of an event caused by an infectious agent, genome sequencing data if available” as well as “implemented and other related information as per request of WHO”. The EU also has a proposal under Article 7 which has complementary interests to the Article 6 proposals, that would obligate States Parties to share genetic materials, but without any mention of benefit sharing. While the USA is not a Party to the Convention on Biological Diversity (CBD) and its Nagoya Protocol the EU and its Member States are Parties and thus have existing international obligations on access and benefit sharing (ABS). Nevertheless, the USA was heavily involved in the CBD negotiations and is a signatory though it did not ratify the CBD. As such international law requires the USA to still act in good faith and to refrain from acts which would defeat the object and purpose of CBD. [Article 18 of the Vienna Convention on Law of Treaties requires a State to refrain from acts which would defeat the object and purpose of treaty “when it has signed the treaty, subject to ratification, acceptance or approval, until it shall have made its intention clear not to become a party to the treaty. U.S. so far as the UN Treaties webpage shows, has not made any declaration regarding its intention not to ratify CBD. It continues to actively participate as an “observer State” in the Conference of Parties to the CBD and in many other meetings of its subsidiary bodies.”] The international ABS regime imposes an obligation on Parties and entities accessing pathogens or related information to fairly and equitably share the benefits emerging from the use of such pathogens or related information, including health products such as vaccines, diagnostics and therapeutics. For instance, WHO’s Pandemic Influenza Preparedness Framework (which the USA does support) establishes a benefit sharing mechanism to smoothen the sharing of pandemic influenza virus or related information. The EU, however, also proposes the following language which could be seen as an indirect recognition for setting up ABS rules for genetic sequence data of pathogens: “With the aim of fostering event related research and assessment, the WHO shall make the information received available to all Parties in accordance with modalities to be adopted by the Health Assembly.” Developing countries, on the other hand, have submitted some proposals which seek to have a responsible regime of information sharing which takes into account the need for benefit sharing and balancing the health security agenda of developed countries with equity for developing countries. The Africa Group clearly proposes that the sharing of genetic materials of genetic sequence data should be based on a Standard Material Transfer Agreement (SMTA) developed by Member States. The proposal reads: “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”. Malaysia made a proposal pointing to the need for taking into account the capacities of States Parties in sharing genetic sequence data. It also proposed that WHO shall not transfer public health information received pursuant to Article 6 “to establishments, personnel, non-state actors or any recipient whatsoever engaging directly or indirectly with conflict and violence elements. WHO shall also handle the information in a manner designed to avoid such actors accessing the information, directly or indirectly”. Removal of Consultation (Article 9) Article 9 allows WHO to “take into account reports from sources other than notifications or consultations and shall assess these reports according to established epidemiological principles and then communicate information on the event to the State Party in whose territory the event is allegedly occurring”. Under this paragraph WHO is under an obligation to consult the State Party in whose territory the event is allegedly occurring and also to attempt to verify the information obtained from other sources. The details of consultation with the State Party are contained in Article 10. The USA proposes to delete the mandatory consultation from Paragraph 9 of the Article. This gives the power to WHO to proceed with actions based on the information received without the mandatory consultation with the concerned State Party for verification under Article 10. As shown below, the USA proposes mandatory sharing of such information without consultation and verification with concerned State Parties to other State Parties under Articles 10 and 11. Verification (Article 10) The USA has proposed several amendments under Article 10 which essentially takes away the process of consultation prior to verification of information, and also sets a narrow time frame to accept or reject the offer of collaboration from WHO in assessing potential for international disease spread, possible interference with international traffic and the adequacy of control measures including through on-site assessments. First, in Article 10(1) the USA proposes to set a 24-hour timeline for WHO to request for the verification of information from other sources with the concerned State Party without undergoing a consultation process under Article 9. Secondly, the USA proposes to remove the reference to Article 9 in Paragraph 2, which deals with the timeline and list of information to be verified. It further adds references to Paragraphs 1 and 2 of Article 6, thereby ensuring the duty of States Parties to provide verification on specific components of public health information as listed in Article 6(2). It must be noted that this proposal will empower WHO to require genetic sequence data of pathogens or other biological information from States Parties. Thirdly, the proposal sets a 24-hour timeline for WHO to offer assistance to collaborate with the concerned State Party. Currently there is no such time limit. Such assistance is primarily for “assessing the potential for international disease spread, possible interference with international traffic and the adequacy of control measures. Such activities may include collaboration with other standard-setting organizations and the offer to mobilize international assistance in order to support the national authorities in conducting and coordinating on-site assessments”. Fourthly, a new paragraph 3bis has been proposed, which sets a strict timeline of 24 hours for the State Party to request clarifications on the offer to collaborate. Failure to respond within 48 hours from WHO’s initial offer of collaboration will be deemed as a rejection of the offer. The proposed paragraph reads: “Within 24 hours of receiving a WHO offer of collaboration, the State Party may request additional information supporting the offer. WHO shall provide such information within 24 hours. When 48 hours have elapsed since the initial WHO offer of collaboration, failure by the State Party to accept the offer of collaboration shall constitute rejection for the purposes of sharing available information with States Parties under Paragraph 4 of this section”. Fifthly, the proposal seeks to amend Paragraph 4 to remove the discretion of WHO to share the information immediately after the non-acceptance of the offer of collaboration (i.e. 48 hours) with other State Parties, without taking into account the views of the concerned State party. The current Paragraph 4 provides discretion to WHO by using the verb “may” and also requires WHO to take into account the views of the State Party concerned. The USA seeks to replace “may” with “shall” and to delete the clause requiring WHO to take into account the views of the State Party concerned. Apart from the USA, New Zealand also proposes two amendments to Paragraphs 1, 2 and 3, which aim to speed up the verification process, and offer for collaboration, as soon as possible without any specific timeline. It must be noted that the timeframe proposed by the USA is highly impractical, because both the State Party and WHO are given only 24 hours each to request clarifications or offer of collaboration, and to respond respectively. This means by the time States Parties receive clarifications from WHO, the time for accepting or rejecting the offer will have lapsed. WHO will then be free to take actions based on the claim that it deems the concerned State Party has rejected the collaboration offer. Provision of Information by WHO (Article 11) Article 11 of IHR sets the contours of information obtained from State Parties and other sources by the WHO. Paragraph 1 of Article 11 allows the WHO, subject to Paragraph 2, to share the relevant public health information, which is necessary to enable the States Parties to respond to the public health risk and relevant intergovernmental organizations, as appropriate. WHO may also share the information that might help States Parties in preventing the occurrence of the same events. Paragraph 2, however, is worded in the reverse, i.e. that WHO shall not share information it received under Articles 6, 8 and Article 9(2) unless otherwise agreed upon by the Member States until such time: (a) a PHEIC is declared under Article 12; or (b) information evidencing an international spread of disease is confirmed by WHO; or (c) evidence shows that control measures are not likely to succeed against the international spread or State Parties (affected) lack sufficient capacities to carry out necessary measures; or (d) the infection or contamination requires the immediate application of international control measures. The USA proposal is attempting to alter the measured approach of Article 11 in the reverse direction. It seeks to make it obligatory on WHO to share the information under any of the above situations. It also proposes to expand the scope of the situation under which information is to be shared under Article 11 by adding an overarching condition as sub-paragraph (e), which says: “WHO determines it is necessary that such information be made available to other States Parties to make informed, timely risk assessments.” Meanwhile the EU has proposed to change the title of this provision to “Exchange of Information” from “Provision of Information by WHO”. The net effect of the changes proposed to Article 11 is that WHO is obligated to share all the information that it receives, with every Member State, irrespective of the source, on a precautionary basis. Further, the USA proposal to create the obligation to share information has retained the exception in Article 11, i.e. “unless otherwise agreed upon by other Member States”. As a result, this exception will help powerful countries to still guard against proactive sharing of information by WHO against their interests. In another interesting proposal, the USA seeks to alter WHO’s obligation to consult the affected State Party under Article 11(3) to inform the affected State Party of its intent to make the information available. This takes away the opportunity of States Parties to raise their concerns at the international forum. Moreover, a consultation is a significant tool that can help assess the ground realities. Another problem with the proposed amendment is that in the text of Article 11(2), a designated authority is identified only with regard to Article 11(2)(a). The rest of the sub-paragraphs of Article 11(2), including the newly proposed sub-paragraph (e), does not specify any authority within WHO in charge of providing information. The provisions simply say “WHO”. The definition of WHO in Article 1 also only says “World Health Organization”. Determination of PHEIC (Article 12) Under Article 12, the WHO Director-General has to consult with affected States Parties in whose territory the event is happening before (s)he convenes an Emergency Committee (EC). Under Paragraphs 2 and 3 of Article 12, a timeline of 48 hours has also been accorded to the Director-General to convene a meeting of the EC after consulting with the State Party in whose territory the emergency is occurring, with a view to reaching agreement between him/her and the State Party. The Director-General may also convene an EC after 48 hours even if the affected State Party does not agree with the WHO. The USA has proposed several changes to this provision as well. The proposal seeks four important changes, among many others: First, it proposes to give notification to all States Parties even before an EC is called to convene, when the WHO Director-General considers that a potential or actual public health emergency of international concern is occurring. Secondly, it introduces new concepts like “public health emergency of regional concern” and “intermediary health alert” to be determined by the Regional Director or the Director-General. Thirdly, it proposes to remove the 48-hour gap provided for the consultation process with Member States for the establishment of the EC. Fourthly, it proposes to have consultations with all relevant States Parties, which may include States Parties which are not affected by the spread of disease or PHEIC, in order to determine if the PHEIC has ended. It is highly probable that with each of the intermediary health alerts, unwanted interruptions in international traffic and trade can happen as recently experienced by Southern African countries immediately after their notification of the Omicron variant to the COVID-19 virus. Further, a public health emergency of regional concern can be used to differentiate many outbreaks or events from a PHEIC, and consequently developed countries could abdicate from their responsibility and duty to collaborate and provide assistance to affected States.+
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