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TWN Info Service on Health Issues
24 April 2024
Third World Network
www.twn.my
WHO: Developed countries push for dilution of WGGIHR Bureau’s text proposal on equity
Geneva, 24 April (TWN) – Developed countries are pushing to dilute the proposal on equity from the Bureau of the Working Group on Amendments to the International Heath Regulation 2005 (WGHIR).
The Bureau’s proposal is itself weak already as it lacks an effective implementation means to address the lack of equity in IHR especially its silence on access to health products and the lack of financial vehicle to assist the implementation.
The 8th meeting of the WGIHR is taking place from 22 to 26 April at the WHO Headquarters in a hybrid mode.
The first day of WGIHR8 discussed the Bureau’s proposals on Articles 13 and 44 immediately after the opening plenary. There were no statements from the regional groups or individual Member States.
Article 13: Equitable Access
The Bureau proposed three new specific paragraphs focusing on equitable access viz Paragraphs 7, 8 and 9.
Paragraph 7 states: “WHO shall support States Parties and coordinate response activities during public health emergencies of international concern, including pandemic emergencies. To facilitate equitable access to health products, this support shall include, as necessary, coordinating with mechanisms and networks that facilitate equitable allocation and distribution of health products, including through technology transfer on mutually agreed terms. The aforesaid mechanisms and networks may include, but are not limited to, regional ones and those established under relevant international agreements”.
While the majority of Member States support the retention of the text developed countries proposed textual suggestion aiming to dilute the Bureau’s proposal. The group of developing countries include Ethiopia, Fiji, Malaysia, Africa group, Brazil, Mexico, Dominican Republic, India, Saudi Arabia, Brunei, Qatar, UAE, among others.
Australia and the United Kingdom proposed to add the word “relevant” before “health products”, which will limit the scope of health products. It will impose the burden of proof on WHO to show the relevance of the product for response to a Public Health Emergency of International Concern (PHEIC).
Another suggestion from Australia, Israel, Japan, the European Union, the UK and the United States is to insert the word “voluntary” before “technology transfer”. The Bureau’s proposal to provide a mandate to WHO on technology transfer under Paragraph 7 is already qualified with the words “mutually agreed terms”.
On Paragraph 8 (a) Japan, Monaco and New Zealand put a reservation on the term “affordability”. According to the Bureau’s text the Director-General of WHO is to carry out an “assessment of the availability and affordability of health products needed for the public health response”. The effect of deletion of the term “affordability” will limit the scope of assessment only to availability in the market. In the absence of assessment on affordability it would be extremely difficult to initiate steps to facilitate equitable access.
According to the proposed Paragraph 8 (b) the WHO Director-General is to “make use of existing WHO-coordinated allocation mechanism(s) and networks, or facilitate their establishment as needed, to assist States Parties to access relevant health products based on public health risks and needs”.
The US, the EU, Canada and Monaco proposed to do away with the mandate to WHO to make use of the existing coordination mechanism by proposing the deletion of the following words from Paragraph 8 (b): “make use of existing WHO-coordinated”. The US and Monaco proposed a substitution of those words with “coordinate with existing distribution”. This effectively means the Director-General is left with only a coordination role and cannot really use the WHO’s existing coordination mechanism like the International Coordinating Group (ICG). According to the WHO webpage on IGC its core mandate is “to make available and ensure equitable access to licensed vaccines for cholera, meningitis, yellow fever, and Ebola virus disease during outbreaks.”. Thus the proposal from the US will weaken an existing mechanism.
Further, Japan proposed the deletion of the words “facilitate their establishment as needed” from the proposed Paragraph 8(b).
The proposed Paragraph 8(e) mandates the WHO Director-General to take measures to “support States Parties, upon their request, to strengthen local production; achieve quality assurance through regulatory approval of locally manufactured products; and facilitate research and development and technology transfer on mutually agreed terms.”
The EU proposed to insert the term “voluntary” before “technology transfer” to further limit the mandate. The insertion would limit the freedom of WHO to carry out certain ongoing activities, which has the potential to contribute to technology transfer such as the International Pharmacopeia, WHO Reference Cell Banks, Vaccine Standardisation etc.
Bangladesh, Brazil, China, Indonesia and Malaysia called for the retention of the Bureau’s text.
Paragraph 9 deals with the obligation of State Parties to support WHO’s efforts to facilitate equitable access under Paragraphs 7 and 8. The Chapeau of Paragraph 9 reads “Pursuant to paragraph 5 of this Article, and paragraph 1 of Article 44 of these Regulations, States Parties shall, to the fullest extent possible, according to their national law and available resources, and upon request of other States Parties or WHO, undertake to collaborate with each other and to support WHO-coordinated responses activities, including through …”
Developed countries added textual suggestions to qualify the Chapeau further making the obligation ineffective. For instance, the US proposed deletion of the word ‘fullest” before the word “extent”. Japan proposed addition of the word “policy” before “law”. Similarly, Australia and Monaco proposed to replace the words “available resources” with “circumstances”.
With all these changes the sentence may read as: “Pursuant to paragraph 5 of this Article, and paragraph 1 of Article 44 of these Regulations, States Parties shall, to the extent possible, according to their national policies and law and circumstances …”
The US proposed changes on proposed Paragraph 9 (a), which currently reads: “…supporting WHO in implementing actions outlined in paragraph 8 of this Article”. The suggestion from the US is to change it as follows: “Supporting the implementation of this Article”.
Paragraph 9 (b) proposes States Parties to “engaging with, and encouraging, relevant non-State actors1 operating in their respective jurisdictions, to contribute towards equitable access to health products needed to respond to a public health emergency of international concern”. The US proposed to replace the words “non-state actors” with “stake holders”, and the words “contribute to” to be replaced with “facilitating”.
Another target for dilution is Paragraph 9(c). It reads: “… publishing relevant terms of government-funded research agreements for health products needed to respond to a public health emergency of international concern, as well as information, where relevant, on pricing policies regarding these products and technologies, in order to support equitable access”.
The US and Japan proposed to add the word “considering” before “publishing”. This would make the whole paragraph a best endeavour provision. However, the US and Japan suggested further qualification by suggesting to add the words “as appropriate” after “publishing”. Both countries also proposed a few more suggestions. According to them the paragraph would read as follows:
“… (c) Considering and publishing, as appropriate, relevant terms that promote timely and equitable access in government-funded research and development agreements related to promoting equitable and timely access to health products relevant to respond to a public health emergency of international concern, as well as where relevant, on affordable pricing policies regarding these products in order to support equitable access, subject to applicable law”.
Nigeria and Bangladesh proposed a new Paragraph 9 (d) to address the challenges of intellectual property on equitable access. It reads: “… providing exemptions in their intellectual property laws and related laws and regulations, to the exclusive rights of intellectual property holders to facilitate the manufacturing, export and import of the required health product, including their materials and components”.
Interestingly Japan, Switzerland and Russia called for the deletion of the entire Paragraph 9. Australia, the Africa Group, Egypt, Brazil, Uruguay, Fiji, Malaysia, Mexico, Colombia and United Arab Emirates called for the retention of the entire Paragraph 9.
The Bureau’s proposal has a clear mandate to WHO to assist State Parties in the facilitation of equitable access. In Article 44 also the Bureau suggested to have an additional sub paragraph (e): “… facilitating equitable access to health products through WHO-coordinated mechanisms”. However, the US proposed deletion of reference to WHO Co-ordinated mechanism and added the phrase “known mechanisms and networks for allocation and distribution”.
As per the US proposal the text would read as follows: “Facilitating equitable access to health products through known mechanisms and networks for allocation and distribution”.
Article 44(2 bis): Financial Assistance
The Bureau’s text proposed a change to the title of Article 44 from “collaboration and assistance” to “collaboration and assistance including financial assistance”. Japan, Switzerland, the US, Republic of Korea, Israel proposed the deletion of the proposed change in the title of the Article.
Further, on the proposed new Paragraph 2 bis (a) of Article 44 the US has proposed the deletion of the words “in particular developing countries”. This would undermine the very purpose of financial assistance for IHR implementation. Similarly, in sub-paragraph 2 bis (b) the US proposed the deletion of developing countries, which originally was proposed as follows: “Encourage governance and operating models of existing financing entities and funding mechanisms to be responsive to the needs and national priorities, related to these Regulations, of developing countries; …”
Paragraph 2 bis(c) proposes the possibility of linking the financial assistance with funds to be established under the pandemic instrument. It reads: “… secure the financial resources necessary to support the implementation of these Regulations through coordination and/or funding mechanisms that may be established in future International Agreement(s) related to pandemic prevention, preparedness and response”.
The EU proposed mainly two changes in this sub-paragraph to oppose the establishment of any dedicated fund for the implementation of IHR and the pandemic instrument. First, it proposed the deletion of the word “funding” and thus opposed reference to creating a funding mechanism for the implementation of IHR. Secondly, the EU proposed the replacement of the word “established” with “defined”.
Further Canada, Japan, Switzerland, the EU, the US, the UK, Australia, Republic of Korea, Israel, proposed deletion of major contents in Paragraph 2 bis(d) of Article 44, which propose a process to establish a dedicated fund within the IHR framework for its implementation. It reads:
“Review the effectiveness of the provisions in this paragraph two years from their entry into force, and address identified gaps in financing IHR implementation that are not being met by current or future domestic funding, existing and new bilateral, sub-regional, regional and multilateral funding mechanisms, including, if necessary, through the establishment of a dedicated financing mechanism to provide targeted, supplementary financing, in particular to developing countries, to build, strengthen and maintain the capacities required under these Regulations”.
These countries retained only the review mandate in Paragraph 2 bis(d). Developing countries on the other hand proposed the establishment “of a fund under the WHO to provide financing to support, strengthen and expand IHR core capacities as well as capacities needed for preventing, and responding to health emergencies, particularly in developing countries”.
According to a developing country delegate,“It’s surprising that developed countries speak about compliance and international review of core capacities. But they don’t want to commit to any obligation to provide financial assistance or technology transfer. At first, they wanted us to go to external financial agencies and were telling us they will work with external agencies to look into our priorities, but now they don’t even want to commit that they will encourage external agencies to do so.”
A communication from the Bureau to Member States after the conclusion of the first day of the WGIHR8 discussions stated that the Bureau would review the feedback and update the text on Articles 13 and 44 by 25 April. This unilateral revision of the negotiating text by the Bureau would be problematic because it may lead to further dilution of the equity provisions.
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