|
TWN Info Service on Health Issues
7 December 2023
Third World Network
www.twn.my
WHO: WGIHR Bureau’s proposals raise concerns on early harvest approach at the cost of equity
Geneva, 7 December (TWN) – Proposals on various textual amendments to the international Health Regulations (IHR) from the Bureau of the working group mandated to undertake the amendments raise concerns on an early harvest approach at the cost of excluding proposals on equity, especially those on equitable access.
The Bureau of the Working Group on IHR, the negotiating body on IHR amendments, have made proposals on the following Articles and Annexes.
Except for Articles 4, 5, 15 to 18, 24, 27, 35, 42 and 43 as well as Annexes 4 and 6 the Bureau propose retention of the current language in Articles 8, 9, 19, 23, 28, 31, 36, 45, and 56 and Annexes 3 and 8.
The fifth meeting of WGIHR (2 -6 October 2023) empowered the Bureau to produce the textual proposals with assistance from the Secretariat. The report of the 5th WGIHR states that there will be “preparation, as relevant, by the Bureau, with the assistance of the Secretariat, of draft text proposals based on the discussions so far, for consideration by the Working Group at its sixth meeting, without prejudice to the status of the proposed amendments by States Parties”.
The 6th meeting of WGIHR (7 – 8 December) is to discuss the Bureau’s proposals. According to the draft programme, discussions are to take place on the Bureau’s proposals on the following Articles and Annex: Articles 4–9, 15–19, 23, 24, 27, 28, 31, 35, 36, 42, 43, 45, 56, and Annexes 3, 4, 6 and 8.
Interestingly, proposals of the Bureau are silent on equity-related proposals, especially on the proposed new Article 13A, Article 44 bis and proposed changes to Annex 1 and a new Annex 10. The draft programme states that Member States are invited to update on the proposals on the following Articles:
- Article 13A on Equitable access to health products, technologies and know-how for public health response (Africa Group and Bangladesh);
- Articles 44 and 44A, and Annexes 1 and 10 – Current technical support, capacity building and collaborative activities undertaken (Saudi Arabia);
- Article 53A on Establishment of an implementation committee (Africa Group);
- Article 53 bis-quater on the Compliance Committee (United States of America);
- Article 54 on reporting and review (Malaysia) and Article 54 bis on Implementation (European Union).
The apprehension is that the Bureau’s text may lead to demand for early harvest form developed countries and the Secretariat, which will lead to the effective marginalisation of negotiations on equity-related proposals. Equity is one of the identified issues to be addressed as part of the IHR amendment. The WHO Executive Board decision 150 (3), which sets the scope of IHR amendment states:
… “to urge Member States2 to take all appropriate measures to consider potential amendments to the International Health Regulations (2005), with the understanding that this would not lead to reopening the entire instrument for renegotiation. 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), and their universal application for the protection of all people of the world from the international spread of disease in an equitable manner”.
Important Proposals of the Bureau
The Bureau has circulated its own textual proposals for amending various provisions, taking into account the proposals made by States to amend IHR 2005. The Bureau has provided much more limited and streamlined textual proposals in a number of provisions attempting to forge an early convergence.
The Bureau has also provided reasons and explanations on how their text proposals seek to be inclusive of proposals made by States Parties and if not, how their proposals differ from such proposals, and how they serve the objectives of the States who proposed such excluded proposals.
Article 4: Creation of National IHR Authority
The Bureau proposes the creation of two more institutions other than the IHR focal point for the implementation of IHR at the national level viz. a National IHR Authority and a competent authority. The proposal provides an option to States Parties to implement the functions of these three institutions through any one institution. However, the proposal does not offer any effective solution to address the financial and technical assistance required for the effective functioning of either the National IHR Authority or the competent authority.
Regarding assistance paragraph 3 of the Bureau’s text reads: “States Parties shall, as necessary and appropriate, enable the above-referenced entities to discharge their responsibilities effectively, including by providing them with adequate financial and human resources and enacting or adapting existing national law. WHO shall, in accordance with Article 44, collaborate with States Parties, upon request, to support the implementation of this Article”.
However, in Article 44 the obligation of WHO to provide assistance is qualified by the words “to the extent possible”. Article 44.2 states:
WHO shall collaborate with States Parties, upon request, to the extent possible, in:
(a) the evaluation and assessment of their public health capacities in order to facilitate the effective implementation of these Regulations;
(b) the provision or facilitation of technical cooperation and logistical support to States Parties; and
(c) the mobilization of financial resources to support developing countries in building, strengthening and maintaining the capacities provided for in Annex 1.
The proposed role of the National IHR Authority and the Competent Authority are as follows:
(a) The National IHR Authority shall:
(i) coordinate the implementation of these Regulations within the territory of the State Party;
(ii) oversee the National IHR Focal Point and Competent Authority in the performance of their functions; and
(iii) perform any other function that is not explicitly attributed to either the National IHR Focal Point or the Competent Authority in these Regulations.
(c) The Competent Authority shall:
(i) be responsible for the implementation and application of health measures under these Regulations pursuant to Article 22;
(ii) identify the competent authorities at each designated point of entry in its territory pursuant to indent (b) of Article 19; and
(iii) implement other relevant provisions related to conveyance operators and travellers.
Articles 15 to 18: Recommendations of WHO Director-General
Article 15 provides authority to the WHO Director-General (DG) to issue temporary recommendations, while Article 16 provides for issuance of standing recommendations. Article 17 enlist certain considerations WHO DG has to make for issuing recommendations and Article 18 provides an inclusive list of issues upon which recommendations may be issued by the WHO DG.
The amendment proposals from States Parties included explicit authority to issue recommendations regarding access to health products and technologies required to respond to public health emergencies of international concern in Articles 15 and 16. These proposals have been diluted in the Bureau’s proposal. The Bureau’s proposal is to add an additional paragraph in Articles 15 and 16, where the WHO DG may provide “guidance on access to, and allocation of, health products, technologies and know-how through WHO-coordinated mechanisms”, while he/she issues recommendations.
The proposal is vague and does not clarify the need for qualifying the recommendations with regard to access to health products as “guidance”. There is no explanation why the WHO DG cannot issue recommendations regarding access to and allocation of health products. The Bureau’s proposal is against the current practice as well, since several times during the COVID 19 pandemic, and Monkey Pox outbreaks, the WHO DG had issued recommendations on the very same issue. There is no reason to alter this practice.
The Bureau’s proposals for Articles 17 and 18 streamline the proposals made by various States Parties. The Bureau proposes to take into account the availability of relevant health products, technologies and know-how, including in the context of a WHO-coordinated mechanism for access to and allocation of health products”, as a consideration while issuing recommendations. A similar proposal is made to Article 18 as well, such that the recommendations are qualified in a way that recommendations must take into account the need for “essential international travel, including movement of essential health workers”; and the “international supply chains, including for essential health products and food supplies”.
Furthermore, the Bureau’s proposal for Article 15 authorises the WHO DG to offer States Parties assistance in mobilising an international team of experts for on-site assistance. However, this is redundant because WHO is already able to offer such assistance upon request by States Parties under Article 13.
Articles 19 to 31: Amendments to provisions relating to traffic and trade
There were few amendment proposals from States Parties associated with these Articles. Primarily, the proposals relate to bringing more order into cross border transport, by making a few changes including:
(i) bi-national contingency plans;
(ii) legitimising on-board quarantine and isolation; and
(iii) use of digital documents for clearance of immigration or related travel processes.
The Bureau however proposes not to adopt all such proposals, asserting that these are part of discretionary powers already recognized with regulatory authorities. With regard to use of digital documents, the Bureau proposed to address the same in Articles 35 and 36 where health documents as such are regulated.
Nevertheless, a dangerous proposal from the Bureau is that it empowers conveyance operators to implement measures such as isolation and quarantine in Article 24. The proposal obligates States Parties to take all practicable measures to ensure conveyance operators comply with health measures such as quarantine and isolation on-board. Although worded as an obligation under Article 24, the implication is that this enables conveyance operators to implement measures such as isolating passengers etc. This empowerment must be strictly circumscribed with obligations to be fair, proportionate and reasonable. Measures taken up by conveyance operators should be subject to human rights law and standards.
The Bureau, however, argues this is not important because human rights apply as a general principle under Article 3 of IHR 2005. This reasoning shows low ambition to maintain human rights standards, since Article 3 only applies to States Parties, and Article 24 actions are implemented by conveyance operators who are not necessarily government officials.
Articles 35 and 36: Health Documents
Article 35 is currently a general rule relating to health documents, while Article 36 deals with certificates of vaccination or other prophylaxis. Countries like Argentina, Brazil, Bolivia, Uruguay and Paraguay wanted to expand Article 36 to other documents in line with their proposals relating to Articles 19 to 31. They wanted to enable the World Health Assembly to review and approve the document formats for these documents, both in paper form as well as digital form.
However, the Bureau is of the opinion that Article 35 as the general provision relating to health documents is the best place to address some of these proposals and has proposed the following language as an alternative to various proposals from States Parties relating to documents mentioned in Articles 19 to 31 as well as Article 36:
“2. Health documents issued under these Regulations may be issued on paper, digital format or any other possible formats, subject to obligations regarding format of any State Party deriving from other international agreements.
3. Regardless of the format in which health documents have been issued, each State Party shall accept as valid the health documents issued by other States Parties, as long as measures for ascertaining their authenticity are provided in the documents.
4. WHO, in consultation with States Parties, shall develop and update, as necessary, technical recommendations including specifications or standards related to the issuance and ascertainment of authenticity of health documents in digital format. Such specifications shall be in accordance with Article 45 regarding treatment of personal data.”
The Bureau’s approach is that the issue relating to specifications and standards of such documents can be left to the WHO Secretariat and there is no need for an intergovernmental negotiation to adopt such standards. While this may be the current practice in the WHO, especially as the World Health Assembly has very limited time to go into the technical issues such as health documents, it must be noted both under IHR 2005 and the proposed new pandemic instrument, there are proposals to have annual meetings of governing bodies for the instruments and these bodies may allocate time to engage in these issues.
Articles 42 and 43: Implementation of Health Measures
Article 42 maintains a general obligation to implement health measures pursuant to IHR 2005. Article 43 provides for implementing additional health measures other than what are recommended by the WHO and certain limitations to employing such additional measures.
Several developing countries wanted to improve the language of Articles 42 and 43. The problem with Article 42 is that it lacks a specific mention about who is obligated to implement the measures. Developing countries thus proposed that “States Parties” will be responsible for implementing measures.
They also proposed that implementation of health measures must not only be transparent and non-discriminatory, but also equitable. They further proposed to specifically mention the measures taken for ensuring equitable access to health products and technologies and also that States Parties must ensure the non-State Actors under their jurisdiction must also act consistently with these measures.
The Bureau, however, ignored all of these proposals except for the last proposal. The Bureau now suggests including an additional sentence to Article 42 which reads thus: “States Parties shall take all practicable measures, consistent with relevant national law, to ensure that non-State actors operating in their respective jurisdictions comply with and implement health measures taken pursuant to these Regulations.”
Similarly in Article 43, there is a detailed proposal from the Africa Group which gained support from several other countries such as Bangladesh, Egypt, Iran, Brazil, Indonesia, Columbia and Malaysia. The proposals provide for an aggrieved State Party to approach WHO if the additional health measures taken up by other States Parties affect them or their people and a time bound process by which a solution has to be arrived at. The Bureau’s proposal however does not include such a process. Their proposal is to make WHO merely an information channel between the States Parties in this regard.
Further, the Bureau’s proposal maintains a position that additional health measures should not interfere with access to health products required for responding to a public health risk.
Articles 45 and 56: Bureau retains original text
Article 45 currently deals with Treatment of Personal Data and Article 56 deals with Dispute Settlement. There were proposals from Japan and a few other developing countries to allow sharing of personal data in certain situations in Article 45. The Africa Group has proposed to limit cross border data transfer, while providing for access to data. In Article 56 Brazil alongside MERCOSUR region has proposed some amendments to deal with issues relating to additional health measures,
The Bureau however proposes to avoid all these amendments and seeks to retain the original text. With regard to Article 45, the claim is the proposed ideas are still doable within the existing text. With respect to 56, the Bureau makes a claim that Article 43 addresses the issue already.
|