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Info Service on Health Issues (Mar23/02) Geneva, 12 March (K M Gopakumar and Nithin Ramakrishnan) – The Working Group on Amendments to the International Health Regulations (2005) (WGIHR) has decided to start text-based negotiations on proposals addressing equity during its third session that will take place on 17 to 21 April. This decision was taken at the second meeting of the Working Group on 20 to 24 February at the World Health Organization headquarters in Geneva. The Working Group was set up under a World Health Assembly resolution in 2022 to carry out the amendments to the International Health Regulations (IHR). The second meeting started to consider amendment proposals. Sixteen countries have submitted amendment proposals, including from the Africa Group, European Union (EU), and MERCOSUR (South American grouping of countries). Developing countries such as India, Malaysia and Bangladesh have pressed for common but differentiated responsibilities in IHR 2005, while countries from the Africa Group and Bangladesh have extensive proposals on equitable access to health products and health systems strengthening. Immediately after the conclusion of the general discussion in the February meeting the Working Group started the first reading of amendments in the drafting group. Drafting group meetings are not open to the public webcast or to non-state actors. At the first reading Member States explained the rationale of their amendment proposals with respect to specific IHR articles, followed by discussions. After the completion of the first reading there was a consensus to cluster the proposals and take these up for text-based negotiations. The proposed clusters are: Cluster
1: Definitions, purpose and scope, principles (Articles 1, 2 and 3) At the time of writing the meeting report was not available yet, but a screenshot of Paragraph 10 of the draft report that was displayed on screen reads as follows: “The Bureau presented a proposal for grouping of the proposed amendments in relevant clusters, based on discussions during the first reading session (Annex 1). There was general support for the proposed groupings and three groups of proposed amendments to be considered at the third meeting of the WGIHR with the understanding that the considerations of the groupings remain flexible and that Articles 2 and 3 will be considered throughout the discussions. It was stressed that amendments should be examined holistically and with due consideration to related articles and the outcome of the negotiations will be presented as a package of targeted amendments in alignment with decision WHA 75 (9).” It was not clear which three groups of proposed amendments (clusters) would be discussed during WGIHR3. The on-screen text of the draft report did not show this list. The full list of clusters and the three priority clusters are expected to be annexed to the final report which will be released in the coming days. However, according to some delegates proposals in cluster 4 will be taken up for negotiations in April i.e. public health response and core capacities (Articles 5, 13 and New 13 A, Annex 1 and New Annex 10). This is expected to be mentioned in Annex 1, which was not shown on screen during the discussion. An email from the WHO Secretariat to Non-State Actors in official relationship with WHO states clusters 10 (Articles 53A, 53 ter, 54 and 54A) and 5 (Article 44 and 44A) will also be discussed in WGIHR3 along with cluster 4. The intersessional meetings of WGIHR may also follow similar cluster-based discussions and prioritization of the clusters on equity. Nevertheless, the nature of intersessional meetings are not yet clear. Russia has emphatically said the results of intersessional meetings cannot be binding. Nigeria and Namibia sought the inclusion of various actors and stakeholders in the intersessional meetings. As a response, the Secretariat urged Member States to consider the intersessional meetings as drafting work and suggested they need not be made open to Non-States Actors. Discussion on the term “Package” During the discussion on the finalisation of the WGIHR2 report Brazil proposed the following sentence towards the end of Paragraph 10: “It was stressed that amendments should be examined holistically and as a package”. The USA opposed the term “package” and proposed the deletion of the term. It said the term prejudges the outcome of the negotiations. Brazil then proposed the phrase “without prejudice to the outcome of the negotiations” to convey the idea that nothing is agreed until everything is agreed. This proposal was supported by Bangladesh. This was followed by a request from India to retain the term “package”. China also supported this and cited the decision of the 75th World Health Assembly (WHA 75. 9) that stated: “… taking into consideration the report of the IHR Review Committee, to propose a package of targeted amendments, for consideration by the Seventy-seventh World Health Assembly, in accordance with Article 55 of the International Health Regulations (2005)”. China said that the term “package” is used in the decision and therefore should be retained. At this stage the co-chair, Dr Ashley Bloomfield, proposed a compromise text, which then formed the basis for the above-mentioned paragraph: “It was stressed that amendments should be examined holistically and with due consideration to related articles and the outcome of the negotiations will be presented as a package of targeted amendments in alignment with decision WHA 75 (9). Demand for “Equity” in the text of Scope and Purpose Apart from various developing country demands for the principle of common but differentiated responsibilities, a mechanism for access and benefit sharing (ABS), and solutions for equitable access to health products such as medicines in the IHR, there were also proposals to amend the text of the scope and purpose of IHR 2005 contained in Article 2 to better reflect equity and health systems readiness. Currently Article 2 of IHR 2005 states: “The purpose and scope of these Regulations are 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 Africa Group, Bangladesh and India have proposed amendments to Article 2. India proposed two amendments. First, to add the term “prepare” immediately after the term “protect against”. This is to explicitly mention preparedness as part of the scope and purpose of IHR. Secondly, to replace the words “public health risks” with “all risks with a potential to impact public health”. This phraseology would allow for health measures to be applied to all forms of risks that would affect public health. Bangladesh proposed the insertion of the phrase “including through health systems readiness and resilience”, after the words “international spread of disease”. This proposal emphasizes the health system approach towards health emergency preparedness and response. The Africa Group proposed to add the following towards the end of Article 2: “livelihood, human rights and equitable access to health products and health care technologies and know- how”. The Group wants to ensure that the prevention, protection, control and public health response measures to health emergencies shall not unnecessarily interfere with not only international travel and trade, but also “livelihood, and human rights” and shall also provide equitable access to health products and health care technologies and know-how. Some States like Namibia highlighted the need to explicitly provide “for equitable access to health products” as a necessary change to not repeat the mistakes of the COVID-19, Monkeypox and Ebola responses. During the discussion many developing countries supported the expansion of the IHR 2005 scope and purpose. Further, Botswana proposed the inclusion of solidarity in Article 2. Kenya supported the idea of equity. Eswatini and Peru supported the Bangladesh proposal of strengthening of readiness and resilience of the health system. Developed countries including the USA opposed all the proposals under Article 2 except the insertion of the word “ preparation”. Australia and the United Kingdom also supported the inclusion of the word “ preparation”. Kenya, in the plenary on behalf of the Africa Group, however stated: “There is a long standing history of States Parties expanding the scope of IHRs. Such expansion should be guided by lessons learnt, and in our case, … the EB (Executive Board) Decision paved the way for this amendment.” Call for “Common But Differentiated Responsibilities” (CBDR) Bangladesh, India and Malaysia proposed CBDR as a part of the principle of IHR under Article 3. One of the major shortcomings of IHR 2005 is that it does not effectively recognise the development divide, and treat developing and developed countries on an equal footing, thus treating unequal State Parties equally. CBDR is a principle which recognizes the common and differentiated responsibilities of developed and developing countries under international environmental law, and is operationalised in, for example, climate change and biodiversity treaties. In the climate change context, the principle of CBDR and respective capabilities (CBDR-RC) recognizes that while responding to climate change is a common responsibility of all countries, developed countries, owing to their enormous economic and technology capacity and the historic contribution to the emission and accumulation of greenhouse gases, have to take up additional responsibilities. For instance they agreed to take on additional responsibility in reducing carbon foot prints and also provide new and additional financial resources to developing countries to assist them to meet their obligations under the UN Framework Convention on Climate Change. Applying the CBDR principle to international health emergency law requires focus on operationalisation of concepts of equity and fairness, and providing the means of implementation to developing countries. Equity: To reflect equity, the IHR 2005 and the new pandemic instrument should not consider developed and developing countries as being equal in their respective capacities to implement obligations. This means that there must be some level of differentiation between developed and developing countries in terms of what obligations both sets of countries would be subject to and what obligations would be applicable only to developed countries. Fairness: Developing countries need policy space and fiscal space to enable them to invest in public health infrastructure facilities based on their own priorities and not those set by international donors. Temporal flexibility for developing countries is needed to achieve their full capacities under IHR 2005, allowing them policy choice to prioritize those capacities, and requiring developed countries to not place conditionalities that alter developing countries’ self-determined public health priorities, while providing financial and technological resources to them. Means of implementation: This should be provided by developed countries, sharing more technologies, supporting endogenous technology development in developing countries, and providing financial resources to help them meet their obligations. An article in the 2020 Netherlands Yearbook of International Law states: “… a more compelling need is the operational mechanisms and the corresponding legal arrangements under the more practical and normative principle of CBDR-RC. Namely, without reforming the current international health system and revising the corresponding legal tools, the concept of solidarity remains a holy yet hollow concept. To reform the entire international health regime is a huge project and is beyond the scope of this chapter. Nevertheless, to substantiate the principle of solidarity with more detailed and practical meaning, the CBDR-RC principle may serve as the first step of rebuilding the international health regime…” During the first reading Bangladesh, India and Malaysia explained the rationale behind their proposals for the inclusion of CBDR as a principle. During the discussion Brazil stated that inclusion of CBDR does not differentiate countries but make them equal. As expected most developed countries such as Australia, Japan, New Zealand, Norway, the European Union, UK and USA opposed the inclusion of CBDR as a principle under Article 3. However, the USA recognized in principle the “different responsibilities, and the different capacities”, expressed their commitment to address challenges needed to be addresses, and to talk honestly to address them. Discussions on Access and Benefit Sharing (ABS) Discussions on ABS took place during the first reading of amendments to Article 6. There are three proposals on the sharing of pathogens or its generic sequence data (GSD) and the benefits arising from their utilization, i.e. from Africa Group, India, and Malaysia. Additionally, the USA, Indonesia and the EU proposed sharing of genetic sequence information without referring to the benefit sharing aspects. The Africa Group’s proposal clearly states that there is no obligation to share GSD, and links such sharing with the prior establishment of an ABS system to facilitate access to pathogens and GSD, and the fair and equitable sharing of benefit emerging from such access. The proposal reads as follows: “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 also proposed that the sharing of GSD be subject to the capacity of the country involved and national legislation. The USA and Indonesia proposed the mandatory sharing of benefits without any corresponding obligations to share the benefits. According to Convention of Bio Diversity and Nagoya Protocol on ABS such access to genetic materials are conditional upon the willingness to share the benefits emerging out of access on a fair and equitable manner. However, in practise though sharing of pathogens or its GSD takes place pharmaceutical companies do not share the products such as vaccines, therapeutics or diagnostics developed using the pathogen samples or its GSD or the technology to produce such products. Further, these companies use IP rights to legally exclude companies from developing countries to produce the generic versions of those products. During the discussion many Africa Group Member States including Ethiopia, Ghana and Namibia made it clear that there will not be any sharing of pathogens or GSD without an ABS mechanism. China also stressed the need for an ABS system. Similarly, Brazil supported the need for sharing of benefits arising from the sharing of pathogens and GSD. The relationship with a proposed WHO Pathogen Access and Benefit Sharing mechanism as mentioned in the Zero Draft of the new pandemic instrument was also explored by the Member States.+
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