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TWN
Info Service on Health Issues (Feb24/03) Geneva, 7 February (TWN) – The Bureau of the Working Group on the Amendment of International Health Regulations (WGIHR) rejected the WHO Secretariat’s proposal to delete equity-related amendment proposals (Article 13 A, Article 44 A and Annex 10). The WGIHR Bureau did not circulate the Secretariat’s proposals as the Bureau’s text. The Secretariat had prepared the draft Bureau text following the decision of the 6th meeting of WGIHR, wherein Member States entrusted the Bureau to prepare a revised text on equity- related proposals. The report of WGIHR6 states: “Regarding the proposed amendments to Article 13, Article 13A, Article 44, Article 44A, Annex 1 and new Annex 10 relating broadly to equity, capacity-building and financing to support capacity-building and the implementation of the International Health Regulations (2005), the Bureau will consider the proposals and facilitate informal consultations during the intersessional period with a view to sharing a revised text ahead of the seventh meeting of the WGIHR.” As is the practice in most of the WHO processes, the Secretariat prepared the documents for the Bureau. The Secretariat had communicated textual proposals on these equity-related proposals on Friday afternoon (2 February) for the consideration of the Bureau. The Bureau had circulated textual proposals on Articles 13 and 44, and Annex 1, but had yet to take a decision regarding the circulation of the Secretariat’s text as the Bureau’s text on Articles 13A and 44A. Article 13 A: Equitable Access to Health Products, Technologies and Know-howThe Africa Group and Bangladesh had proposed insertion of new Article 13A titled “equitable access to health products, technologies and know- how for public health response” to address the glaring gap in the IHR i.e. the silence on the access to health products required for preparedness and response to public health emergencies including public health emergency of international concern (PHEIC). As a result of this gap, IHR functions as a mechanism to provide information on diseases outbreak and helps WHO and those Member States with financial and technological abilities to take measures to protect their own population without any legal obligation to help the Member State providing the information. Since most of the disease outbreaks are happening in developing countries IHR works as a mechanism for developed countries to obtain information without any legal obligation to assist developing countries who face PHEIC. Article 13A proposes a series of measures to facilitate diversified manufacturing of health products required to respond to PHEIC, including the use of exceptions and limitations on intellectual property protection and enforcement, transfer of publicly funded technologies for the production of PHEIC products etc. Further, it also proposes the following obligations on WHO to facilitate diversified production: (a) develop and publish a list of required health products, (b) develop and publish specifications for the production of required health products, (c) develop appropriate regulatory guidelines for the rapid approval of health products of quality including development of immune correlate of protection (ICP) for vaccines, (d) develop and maintain a database containing the details of the raw materials, ingredients, components, design, know-how, manufacturing process, or any other information, required to facilitate manufacturing and equitable access of health products required for responding to public health emergencies of international concern. (e) establish a repository for cell-lines to accelerate the production and regulatory of similar biotherapeutics products and vaccines, (f) review and regularly update WHO Listed Authorities so as to facilitate appropriate regulatory approvals, (g) any other measures required for the purposes of this provision. The Secretariat, however, suggested to not include a dedicated Article 13A, but to include elements proposed in Article 13A, in other provisions of the IHR or to cross refer to provisions of the pandemic instrument being negotiated in the parallel WHO Intergovernmental Negotiating Body (INB). However, they did not show any such mapping except for one or two elements. Neither has the Secretariat proposed any textual language on Article 13A elements in other parts of the provisions of IHR. Article 44A: Financial Mechanism for Equity in Health Emergency Preparedness and Response Article 44. 2 (c) currently mandates WHO to collaborate with States Parties to the extent possible for “the mobilization of financial resources to support developing countries in building, strengthening and maintaining the capacities provided for in Annex 1”. Further, the World Health Assembly Resolution 58.3 in 2005, which adopted the IHR 2005 also request the WHO Director-General to work with States Parties to mobilise financial resources to assist developing countries to meet the IHR obligations. Paragraph 6.6 of the Resolution requests the Director-General “to collaborate with States Parties to the extent possible in the mobilization of financial resources to provide support to developing countries in building, strengthening and maintaining the capacities required under the International Health Regulations (2005);…”. However, so far there is no dedicated fund or a financial mechanism to provide financial assistance within the IHR framework. The IHR Review Committee’s Report on functioning of IHR during the Covid-19 response stated: “States Parties should ensure adequate and sustained financing for IHR implementation at the national and subnational levels and provide adequate and sustained financing to the WHO Secretariat for its work on preventing, detecting and responding to disease outbreaks…”. To address this glaring gap the Africa Group proposed a new article i.e. Article 44A to create a financial mechanism to provide financial assistance to developing countries for the implementation of IHR-related obligations. The proposed Article 44 A reads: “1. A mechanism shall be established for providing the financial resources on a grant or concessional basis to developing countries. Such financial mechanism shall provide the financial assistance to achieve the following purposes: (i) building, developing, strengthening, and maintaining of core capacities mentioned in Annex 1; (ii) strengthening of Health Systems including its functioning capacities and resilience; (iii) building, developing and maintaining research, development, adaptation, production and distribution capacities for health care products and technologies, in the local or regional levels as appropriate. (iv) addressing the health inequities existing both within and between States Parties such that health emergency preparedness and response is not compromised;…”. The Africa Group further proposed that the mechanism will function under the guidance of States Parties, and the World Health Assembly. The Secretariat proposed to not retain this new Article 44A, reasoning that the INB is making great progress to adopt a financial mechanism in the pandemic instrument under negotiation, which in the Secretariat’s opinion will cover not only pandemics but also health emergencies. However, the Secretariat was not clear about why an existing legal instrument should refer to something that might be established in a future instrument, whose fate is in fact not decided. Annex 10: Obligations of Duty to Cooperate The existing language under Article 44 of IHR 2005 which speaks about collaboration and assistance is not legally binding enough to ensure assistance to the States Parties in need or their populations. For example, there is not even an obligation on States Parties to respond to the request for assistance from another country. The forms of collaboration and assistance could vary significantly, and therefore there is no guarantee that the requested help would flow to the requesting party without any conditions attached to it. To avoid perpetuating this uncertainty, the Africa Group proposed a non-exhaustive list of activities in which collaboration or assistance could be undertaken. This list which brings some predictability and specifics into activities that will fall under the scope of Article 44, is then supported by an obligation to collaborate or provide assistance “as requested”. The inability to provide assistance or collaboration as requested must be communicated to requesting States Parties with reasons. The Secretariat has suggested to not retain this provision citing the analysis made by the IHR Review Committee on Amendments to IHR 2005, although the Review Committee’s mandate was not to evaluate any of the amendment proposals made by Sovereign States. Faulty Reasoning The rational of the Secretariat is faulty and ignores the demand to address equity in IHR and to create a health emergency regime based on mutual cooperation and trust. Further, it ignores that fact that the INB negotiation is aiming to conclude an international legal instrument to address prevention, preparedness and response to a pandemic, an extreme form of PHEIC. However, IHR is the legal instrument to address all types of PHEIC. The poor implementation of IHR would lead to greater risk of pandemic. In otherwards according the Secretariat the possibility of equity in the pandemic instrument is a substitute for the lack of equity in IHR. This latest move by the Secretariat in its proposed treatment of States Parties’ equity-related is a complete disregard by the Secretariat of the Executive Board decision (EB 150.3), which mandated issues of equity yo be addressed as part of the IHR amendments. Paragraph 2 of EB150.3 is explicit and unambiguous: “Such amendments should be limited in scope and 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)”. Pointing out that major equity-related proposals, i.e. Article 13A and Article 44A, have not been discussed yet, a developing country diplomat said, “We know what is being played out here is delay tactics. The Secretariat holds the INB Process as hostage for opposing almost all equity-related (IHR) amendment proposals. They are giving signals if we make good progress in equity in IHR 2005, then the Pandemic Treaty agenda will fall apart. The Bureau is being told by the Secretariat what to do and what not to do. At times, it becomes difficult to understand whom we are negotiating with – with the states Parties or with the Secretariat.”
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