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Info Service on Health Issues (Dec21/09) WHO: U.S. pushes onerous IHR obligations on developing countries Geneva, 15 December (Nithin Ramakrishnan and K M Gopakumar) – The United States (U.S.) pushes onerous obligations on developing countries through its proposals to amend the World Health Organization’s International Health Regulations (IHR) 2005. On 2nd December, prior to the 1st informal consultation on IHR amendments, the U.S. circulated its consolidated proposed amendments. It had earlier tabled amendments to Article 11, 12 and 59 of IHR. The consolidated proposal now contains amendments to Articles 5, 6, 9, 10, 11, 12, 13, 15, 18, 48, 49, 53, and 59. Amendments to these 13 articles would substantially change the characteristics of the IHR 2005. The U.S. has reportedly asked WHO Member States to respond to the proposal on or before the 2nd informal consultation to be held on 16th December. The proposal pushes onerous obligations on the following five areas: · Accelerated sharing of information, both to and from WHO; · Sharing of genetic sequence information; · Compulsion to accept WHO’s offer of assistance or collaboration in preparedness and response; · Opening of outbreak sites for international assessment; and · Promotion of multi-stakeholder approaches All these proposals, if accepted, undermine the sovereignty of developing countries and forces them to provide information to developed countries without any assurance of predictable and sustainable assistance to meet the health emergency challenges. The main criticism against the functioning of IHR is that WHO and developed countries often use the IHR mechanism to seek information from developing countries, where often the diseases outbreaks take place, without fulfilling the corresponding duty to cooperate and assist these countries. Any assistance provided is mostly inadequate and carried out outside the framework of IHR as bilateral or unilateral measures, and not as a legal entitlement of developing countries. Accelerated Sharing of Information The U.S. has kept proposals to speed up sharing of information both to and from WHO. Amendments, including timeframes have been proposed in Articles 5, 6, 9,10 and 11 for rapid sharing of information. In Article 5, the U.S. tries to incorporate an early warning system by introducing a new provision Article 5(5) and providing for sharing risk assessment on the events of unknown causes on an early basis. In Article 6(1), the U.S. proposes a 48-hour timeframe within which a State Party should assess the events upon receiving the information and then share the information with WHO within another 24 hours. Currently, Article 6(1) of IHR fixes the timeframe for sharing of information with WHO after the assessment, but not for the assessment itself. The U.S. proposals seek to change this. In Article 9(1), the proposal seeks to do away with the obligation to consult and verify information received from other sources, with the concerned State Parties. Under Article 10(1), it is proposed that WHO has to request the relevant State Party for verification of the information it receives from other sources within 24 hours. It has also proposed that WHO should offer collaboration to assess the events within 24 hours of receiving information in Article 10(3), i.e. when WHO receives information of an event that may constitute a public health emergency of international concern. The U.S. also proposes that State Parties should accept or reject the same within 48 hours by suggesting to incorporate a new paragraph (3 bis) to Article 10. In the same paragraph, the U.S. proposes to obligate WHO to share such information with all State Parties immediately, once the relevant State Party reject the offer of collaboration or does not make a decision within 48 hours. While it is proposed under the new Article 5(5) that WHO shall convey risk assessment with State Parties, the phrase used is any “local, national and global risks”, not just “public health risks”. The U.S. proposal therefore expands the scope of the information to be shared. In another attempt to accelerate information sharing by WHO, the U.S. further proposes to remove or dilute the requirement of prior WHO Consultation with State Parties, on whose territory events are occurring, from various provisions of IHR such as Articles 9(1), 11(3) and 12(2). For instance, according to the U.S. proposal for Article 12, if the WHO Director-General in his/her preliminary determination considers that a potential or actual public health emergency of international concern is occurring, then he/she shall notify all the State Parties, even before he/she seeks to consult the State Party on whose territory potential or actual outbreak is happening or he/she convenes an emergency committee. The U.S. also proposes to delete the phrase “taking into consideration of the views of the State Party concerned” from Article 10(4), where WHO is further proposed to share information with other State Parties immediately after the rejection or non-acceptance of WHO’s offer of collaboration in assessment. It is unfortunately forgotten that a rapid sharing of information requires large investments in building nation-wide surveillance capacities. Studies have been reporting that countries are improving on surveillance capacities over the past decade, while they lack significantly in response capacities. The U.S. proposal, if adopted, would again front-load investments in surveillance capacities. It will alter the related donor preferences to the disadvantage of taking away immediate attention required for resilience and surge capacities of the health systems in the developing countries. More problematically, several suggestions of the U.S. proposal in Article 5 to 13 seek to obligate WHO to share public health information received by it from various sources pro-actively to all IHR State Parties and to the public. Further, the proposed amendments seek to limit the discretion currently available to WHO under the IHR 2005 with regard to sharing the information with other State Parties and the public. The independent panel for pandemic preparedness and response (IPPPR), earlier in its May 2021 report, had recommended to empower WHO to publish the information without requiring prior approval of national governments. The U.S. proposals go even further and will end up with WHO sharing information even without consulting the State Parties providing such information. In short, it can be said the U.S. proposal goes much beyond the precautionary approach. It wants WHO to be always keyed-up rather than exercise precaution. It seeks almost real time, rapid and open access to information without a substantial screening by WHO or by affected State Parties. It goes without saying such an approach is antithetical to the purpose and scope of IHR 2005, i.e., “to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade”. The indiscriminate wide dissemination of such information affects the economy negatively as credit rating agencies, standard setting organizations, donors and financiers all can use this information to further bargain tough deals from the small states and developing countries. This also entails national security concerns. It is interesting to note that while the U.S. is pushing for accelerated sharing of information from State Parties it had put the following reservation to the current Article 9, which obligates State Parties to inform WHO as far as possible within 24 hours of receipt of evidence of public health risk identified outside their territory: “Article 9 of these Regulations obligates a State Party “as far as practicable” to notify the World Health Organization (WHO) of evidence received by that State of a public health risk occurring outside of its territory that may result in the international spread of disease. Among other notifications that could prove to be impractical under this article, it is the United States' understanding that any notification that would undermine the ability of the U.S. Armed Forces to operate effectively in pursuit of U.S. national security interests would not be considered practical for purposes of this Article”. (Emphasis added) Sharing of genetic sequences information (GSI) of pathogens Currently when IHR 2005 speaks about sharing of public health information it does not include sequenced genetic information of the pathogens or other relevant biological materials. Article 6(2) of IHR 2005 which provides an the scope of information to be shared with WHO states thus: “a State Party shall continue to communicate to WHO timely, accurate and sufficiently detailed public health information available to it on the notified event, where possible including 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 U.S. seeks to add the word “Genetic Sequence Data (GSD)” to this list. Such an addition obligates all State Parties including developing countries to share genetic sequence information of pathogens with the WHO and the rest of world therefrom. This frustrates the developing country interests of establishing an effective and legally enforceable “access and benefit sharing mechanism”. For example, any mechanism like the Pandemic Influenza Preparedness (PIP) Framework would then be undermined, even made irrelevant. A 2019 study by Edward Hammond for Third World Network, has reported how sequenced genetic information shared in open platforms, like Genbank, can be used to bypass the requirements of benefit sharing mechanisms under relevant national or international laws. It must be noted that the WHO Secretariat, by developing programmatic tools such as the Global Genomic Surveillance Strategy and voluntary mechanisms like Bio-Hub, is already promoting de facto sharing of pathogens and genetic sequence information without concrete and meaningful commitments to equitably share the benefits developed out of the same, at appropriate levels. GSD or genetic sequence information should not be treated as mere public health information. This information, in most cases, is used in lieu of the biological sample sharing or for overcoming the complex process of sharing of biological materials. Therefore, sharing of genetic sequence information must be subject to the laws and regulations applicable to the access and benefit sharing of genetic resources. The U.S. proposals to amend Articles 6 and 11 further seek to obligate WHO to share information with all relevant entities and the public respectively, which can include private sector undertakings as well. Such information, according to the proposed amendment to Article 6(2) will include sequenced genetic information. The argument is that such a pro-active sharing of resources makes it easier for researchers and industry partners to access the required information and develop or produce relevant health care products and technologies. But the same also makes it easier for such industrial actors to overcome the national legislation and international laws providing for the equitable sharing of the benefits developed out of such resources and to monopolize them using patents or other forms of IP. Compulsion to accept or reject WHO’s offer of assistance According to the U.S. proposals, a State Party will be required to either accept or reject the offer for collaboration or assistance within 48 hours of the offer by the WHO. If the offer is not accepted, then the State Party shall also be mandated to provide reasons for the same. Moreover, WHO is to be obligated to share the information it has received from various sources immediately upon the rejection of the offer by the State Party or non-acceptance within 48 hours. Currently, under Article 10(3) of IHR 2005, WHO shall offer collaboration with concerned State Parties in verifying the information or assessing the related events. When such an offer is not accepted by State Parties, WHO may in its discretion share the relevant information with other State parties, if the same is found justified by the magnitude of public health risk. However, the U.S. proposal seeks to require WHO to offer collaboration within 24 hours of receiving information. It then proposes, in Article 10(4) to obligate WHO to share the information if the concerned State Party does not accept the offer in 48 hours. It proposes to alter the verb “may” with “shall”, indicating such sharing of information shall become obligatory in nature and not discretionary. The U.S. proposes to add a new paragraph 3bis to Article 10 which states: “… 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.” Such compulsive language is also proposed in Article 13, which deals with public health response to events covered under the scope of IHR. These
types of provisions as proposed by the U.S. pressurise developing
countries to accept the offer of assistance, even if it entails opening
up of outbreak sites to the international community or international
expert teams at the cost of national security. Such pressure expands
the inequities and security concerns of developing countries vis-a-vis
developed countries, because of most of the outbreaks happen in developing
countries and It is interesting to note, in contrast, that there is no proposal by the U.S. to amend Article 13(5). This provision requires all State Parties, including unaffected States, to support the WHO coordinated public health response activities to a public health emergency of international concern (PHEIC) when called upon by WHO. In this case, the U.S. proposes no timeframe or compulsion on the State Parties to respond to such a call by WHO. Access to Outbreak Sites The U.S. proposal seeks to add provisions for deployment of international expert teams to the outbreak sites of State Parties, in more than one instance, in particular under Article 15 of the IHR 2005, which provides for temporary recommendations during a PHEIC. Article 15 provides for issuance of temporary recommendations by the WHO Director-General after the meeting of the Emergency Committee, which is convened under Articles 49 and 12 of IHR. The Article 15(2) currently explains the scope of recommendations and states thus: “Temporary recommendations may include health measures to be implemented by the State Party experiencing the public health emergency of international concern, or by other States Parties, regarding persons, baggage, cargo, containers, conveyances, goods and/or postal parcels to prevent or reduce the international spread of disease and avoid unnecessary interference with international traffic.” The U.S. proposal seeks to include the words “the deployment of expert teams, as well as” before the phrase health measure. If accepted, the revised paragraph 2 will read as: “Temporary recommendations may include the deployment of expert teams, as well as health measures to be implemented by the State Party experiencing the public health emergency of international concern…” (Emphasis added) Though Article 15(2) appears to provide a certain degree of discretion, with regard to temporary measures, there are concerns that such discretion will be used against the weaker State Parties considering the institutional weakness of WHO, primarily emerging from its lack of financial independence. The U.S. also proposes to require State Parties to provide reasons if they deny access to the WHO to outbreak sites under Article 13(4). It further seeks to obligate States Parties “to make reasonable efforts to facilitate short-term access to relevant sites.” As mentioned above, this is not in the interest of developing countries, and developed countries themselves can be expected to not comply with impunity. It must be noted that under Article 49(5), the Director-General is the one who makes the final determination on these matters. Therefore the U.S. proposal is very excessive in burdening the decision-making authority of deploying international experts’ teams on a single person. Considering the dependency on voluntary financial contributions from the developed countries or entities in the developed countries, the office of the WHO Director-General can be compromised and pressurized by these countries and entities to make recommendations to deploy external teams. Promotion of multi-stakeholder Approaches The U.S. proposal seeks to incorporate different types of stakeholders into the international public health response system. In its proposals on Article 6(1), U.S. seeks to obligate WHO to provide information to “other relevant entities” alongside the International Atomic Energy Agency (IAEA), the Food and Agriculture Organization (FAO), the World Organisation for Animal Health (OIE) and the UN Environment Programme (UNEP). While all the entities specifically mentioned are international inter-governmental organizations, “other relevant entities” is an open category which can include stakeholders ranging from private persons, loose associations to international non-state actors. It can include standard setting organizations, credit rating agencies, potential development donors and financiers, research organizations, academic institutions, production and manufacturing companies of health care products etc. Over and above this, the U.S. proposal also seeks to establish a compliance committee under IHR 2005 as a new Chapter IV. Article 53 bis (2)(d) says the compliance committee can “seek the services of experts and advisers, including representatives of NGOs or members of the public, as appropriate”. This is a highly intrusive multi-stakeholder approach. Issues like compliance and dispute settlement process are at the very core of the international legal order. A multi-stakeholder approach in the same will compromise not only the State’s sovereign rights and interests, but also the stability and sustainability of international relations. No Proposals for Promoting the Interests of Developing Countries The U.S. proposal does not address any concerns of developing countries, such as the financial and technical assistance to build surveillance and response capabilities to deal with health emergencies including building of resilient health systems, timely and equitable access to health products, checks on unilateral measures, social and economic security during health emergencies, access and benefit sharing for pathogens or sequenced genetic information.+
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