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Info Service on Health Issues (Dec21/04) Geneva, 3 Dec (Nithin Ramakrishnan) — The United States has submitted a proposal to amend the International Health Regulations (IHR) 2005 that pursues a health security agenda without paying any attention to the issue of equity. The US has invited WHO Member States to informally negotiate on amendments to Articles 11, 12 and 59 of the IHR that it has submitted to the Member States Working Group on Strengthening WHO Preparedness and Response (WGPR). The US is organising two informal consultations of Member States on 2 and 16 December to reach a consensus. It is also interesting to note that these informal consultations are much ahead of the WGPR that is mandated to examine the findings and recommendation of various expert panels, which had reviewed the COVID-19 pandemic response. The WGPR is yet to have a focussed discussion on the required changes to the IHR. The US submission to the WGPR contains a resolution for the adoption of the amendment and an annex containing the amendment proposals to Articles 11, 12 and 59 of the IHR 2005. Article 11 governs the information provided by Member States to WHO to help the assessment of whether particular health events constitute a Public Health Emergency of International Concern (PHEIC). Article 12 deals with the determination of a PHEIC. Article 59 sets out the rules for the entry into force of the IHR, and also on rejection or reservations. ARTICLE 11 AND THE PROPOSED CHANGES Article 11 of IHR 2005, as mentioned above, provides for the handling of information 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 respond to the public health risk to all State Parties and relevant intergovernmental organizations, as appropriate and in confidence. WHO may also share the information that might help State Parties in preventing the occurrence of events that may pose public health risks. Paragraph 2, however, is worded negatively, i.e. that WHO shall not share information it received under Articles 6, 8 and Paragraph 2 of Article 9 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) evidences show 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 US proposal is attempting to alter the measured approach of Article 11 and making it obligatory on the WHO to share the information it has received on outbreaks or public health risks with all Member States if any of the conditions above is satisfied. It also proposes to expand the scope of information 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.” [A general understanding of the scope of information that is involved in this process is available in Article 6(2) of IHR 2005 and it 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 a potential PHEIC.] The net effect of the changes proposed in Article 11 is that WHO is made obligated to share all the information that it receives, with every Member State, irrespective of the source, on a precautionary basis. Further, the US proposal to create the obligation to share information has left open 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. There is also another significant proposal to alter Article 11(3), where the US proposes to replace the word consultation with information. This means the WHO only needs to inform the State Party about its intent to make the information available to others under the Article. This takes away the opportunity of the State 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 targeted 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”. Therefore, it could mean that any organ, committee, or an official/personnel in some of the relevant offices of authority, such as World Health Emergencies Programme, can invoke this provision and proactively share information with all State Parties. They can also invoke the wide discretion provided by the proposed changes to protect themselves, while acting in excess of the authority. In short, the US proposed text shall create a problem of accountability in the WHO’s handling of public health information and its confidentiality. ARTICLE 12 AND THE PROPOSED CHANGES Article 12 is one of the most important provisions of IHR 2005. It deals with the determination of the PHEIC status of events coming under the scope of the IHR. It already gives high level authority and far-reaching powers to the WHO Director-General to determine and declare PHEIC read along with Article 49. The US proposal will further enhance the power in the hands of the Director-General. In the existing provision, the Director-General has to consult with affected State 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 concerned, with a view to reaching agreement between him/her and 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 Director-General has further powers to make the determination that a PHEIC has ended after consultation with the State Parties in whose territories the PHEIC has occurred under paragraph 5 of the Article. The US proposal indicates four important changes, among many others. First, 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, as the case may be. Secondly, it removed the process of consultation with Member States and the 48-hour time-frame for reaching a consensus. Thirdly, it proposes to give notification to all State Parties even before an EC is called to convene, and fourthly, it proposes to have consultations with all relevant State Parties, which may include State Parties which are not affected by the spread of disease or PHEIC, in order to determine if the PHEIC has ended. All the suggested changes promote the health security agenda of the US against the interest of the developing countries and creatively paves the way for escaping out of the obligations to collaborate and assist. Already, the definition of PHEIC in IHR 2005 is very narrow; the further differentiations can create more fragmentation of the IHR obligations. It is highly probable that with each of the intermediary health alerts, unwanted interruptions in international traffic and trade can happen as just happened with Southern African countries immediately after their notification of the Omicron variant to the COVID-19 virus. On the other hand, a public health emergency of regional concern can be used to differentiate many outbreaks or events from a PHEIC and thereby escape from most of the obligations laid down for PHEIC under IHR 2005, especially the duty to collaborate and provide assistance to affected states. An important textual change sought by the US on Article 12(2) and 12(3) of IHR 2005 is provided below. It seeks to avoid the 48 hour time-frame taken by the Director-General to reach an agreement with the affected State Party regarding the preliminary determination of PHEIC in order to convene an EC. It also seeks to obligate the Director-General to notify all State Parties of the event and the preliminary determination of a potential or actual PHEIC even before convening an EC. Article 12(2) and (3) of IHR 2005 presently read as follows: “2. If the Director-General considers, based on an assessment under these Regulations, that a public health emergency of international concern is occurring, the Director-General shall consult with the State Party in whose territory the event arises regarding this preliminary determination. If the Director General and the State Party are in agreement regarding this determination, the Director-General shall, in accordance with the procedure set forth in Article 49, seek the views of the Committee established under Article 48 (hereinafter the “Emergency Committee”) on appropriate temporary recommendations. 3. If, following the consultation in paragraph 2 above, the Director-General and the State Party in whose territory the event arises do not come to a consensus within 48 hours on whether the event constitutes a public health emergency of international concern, a determination shall be made in accordance with the procedure set forth in Article 49.” The US proposal deletes paragraph 3 and for Paragraph 2, it proposes the following text: “2. If the Director-General considers, based on an assessment under these Regulations, that a potential or actual public health emergency of international concern is occurring, the Director-General shall notify all States Parties and seek to consult with the State Party in whose territory the event arises regarding this preliminary determination and may, in accordance with the procedure set forth in Article 49, seek the views of the Committee established under Article 48 (hereinafter the “Emergency Committee”). If the Director-General determines that the event constitutes a public health emergency of international concern, the Director-General shall, in accordance with the procedure set forth in Article 49, seek the views of the “Emergency Committee” on appropriate temporary recommendations.” ARTICLE 59 AND THE PROPOSED CHANGES The US proposal to amend IHR Article 59 is with a view to improve the agility of IHR 2005. It proposes to add paragraph 1 biz to Article 59: “The period provided in execution of Article 22 of the Constitution of WHO for rejection of, or reservation to, an amendment to these Regulations shall be 6 months from the date of the notification by the Director-General of the adoption of an amendment to these Regulations by the Health Assembly.” However, limiting the time for reservations and rejection to 6 months, effectively reduces the time for the Member States to conduct inter-ministerial meetings and analyze the implications of amendments suggested in the IHR. It must be noted that amendments to IHR 2005 may involve elements of National Security as seen in this very proposal by the US to amend the IHR. The US proposal also says that “amendments to these Regulations shall enter into force 6 months after the date of notification referred to in paragraph 1bis of this Article”. Such a limited time could compromise informed decision making at the national level. The 18 month time-frame given in the present text of IHR helps the various departments or ministries belonging to the national governments to coordinate and take an informed decision. Therefore, it is important that Member States go with a pragmatic time-line and not a hasty approach. It is learnt that while this report was being prepared, the US has proposed further amendments to many more Articles in IHR 2005. A commentary on those proposals will follow. +
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