Cracks in WHO armour as countries push back on transparency in treaty negotiations

World Health Assembly, Geneva, Switzerland

Editor’s note: Cracks in the weakening armour of the unelected World Health Organisation are becoming more apparent through negotiations on the proposed new pandemic treaty or accord and proposed amendments to the International Health Regulations. Ex-Gavi employee Nina Schwalbe also wrote about the challenges in the Financial Times, while Third World Network exposes below more of the pushback from countries with rightful concerns.

As I highlighted recently, the cartel knows it s in trouble. Schwalbe conceded:

• “The sense of urgency that gripped nations to be better prepared in future has been replaced by complacency.”
• “The most recent round of treaty talks failed to bring a breakthrough in any of the areas of disagreement, signalling serious trouble ahead.”
• “But as this process has played out, political will has ebbed away. Differences of opinion on thorny issues such as data sharing have hardened into near gridlock.”
• “Within months of this bold first draft being released, however, its language was watered down.”
• “The document is mired in platitudes and hands fundamental responsibility back to the very institutions that failed to respond last time.”
• “Perhaps the last chance is the UN General Assembly’s High-Level Meeting on Pandemics in September. The political declaration posted this week under a Covid-era “silence procedure” — which gives limited time for member states to object — offers little hope.”
  Note by: Shabnam Palesa Mohamed. Executive Director. Children’s Health Defense Africa.

TWN Info Service on Health Issues (Sept 23/02)
11 September 2023
Third World Network

WHO: INB Bureau to develop another draft negotiating text

Geneva, 11 September 2023 (TWN) – In the drafting group meeting of the Intergovernmental Negotiating Body (INB) held on 4 – 6 September, Member States decided to entrust the Bureau to develop another draft text of the WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response (the pandemic instrument).

This will be a proposal for the negotiating text for the consideration of the 7^th Meeting of the INB (INB7) that will be held on 6 – 10 November and resumed on 4 – 6 December.

The Bureau will develop and circulate the proposal in English by 16 October and this will be translated into all U.N. languages by 30 October.

TWN learned that a proposal to mandate the Bureau to develop “the negotiating text” was not accepted by the Member States on Wednesday who insisted on the need to examine the proposal before accepting it as the negotiating text.

Further the report of the drafting group meeting, as seen by TWN, states that this mandate of Bureau is without prejudice to the right of any Member State to present textual proposals and to the status of the compilation document containing all Member State textual proposals submitted in April to the INB.

The report states: “The INB Bureau will develop and circulate to the INB for its consideration a proposal for negotiating text of the WHO CA+ (the pandemic instrument) by 16 October 2023 (first an advance unedited English version and the translated versions, as soon as possible and no later than 30 October 2023), based on the discussions of the INB from its fourth, fifth, and sixth meetings, as well as the meeting of the drafting group including its informal consultations, and the reports of the co-facilitators of those consultations. The reports of the co-facilitators will be shared with the INB drafting group. The Bureau will continue to consult with the co-facilitators, as appropriate. It was agreed that the proposal for negotiating text would be without prejudice to the right of any Member State to present textual proposals and to the status of the compilation document”.

The Bureau and a few other Member States who identify themselves as “Friends of a pandemic treaty” were very reluctant to incorporate Member State text proposals in the Bureau’s text released in May. Several text proposals that are on equity which are crucial to protect the lives and livelihoods of people in the developing countries were not adequately reflected in the Bureau’s text.

Member States were asked to address their missing proposals through informal meetings to discuss the merits of their proposal and generate convergence or make compromises even before their text proposals made themselves into the negotiating text. Several rounds of informal discussions took place, but any consensus on those proposals is still far off. More informal meetings have been scheduled prior to the drafting group on 22 September which is to review the progress.

The agenda of the week’s drafting group composed of informal meetings on the following areas.

• Articles 4 (Pandemic prevention and public health surveillance)
• Article 5 (Strengthening pandemic prevention and preparedness through a One Health approach)
• Article 9 (Research and development)
• Article 11 (Co-development and transfer of technology and know-how)
• Article 12 (Access and benefit-sharing)
• Article 13 (Supply chain and logistics).

However, a developing country delegate told Third World Network that these informal meetings seemed like “deja vu”. “Every time you meet on one topic, we keep hearing the same arguments, sometimes we have to check for ourselves whether this is real,” the delegate said.

Articles 4 and 5:  Prevention and One Health

The Co-facilitators from India, Tanzania and the United Kingdom facilitated the informal consultations and circulated the following questions:

1. Whether Articles 4 and 5 should be combined? How?
2. What will be the difference between surveillance and prevention in the International Health Regulations (IHRs) and those proposed in the pandemic instrument?
3. What commitments and obligations in relation to animal health and environmental health should be included in the pandemic Instrument?
4. Whether there are any significant aspects of surveillance, prevention and One Health which are not included in the Bureau’s Text?

However, several Member States including the U.S. expressed concerns regarding the constitutionality of adopting One Health actions into the pandemic instrument, especially as it involves measures belonging to the expertise and jurisdiction of several international organisations, not just the quadripartite of WHO, FAO, WOAH (World Organization for Animal Health) and UNEP.

A few developing countries raised the question as to why the One Health approach is only about environmental factors, while already the quadripartite and One Health High Level Panel have been called upon to include social and economic factors into their work.  Decision 15/29 of the 15^th Meeting of the Conference of Parties to the Convention on Biological Diversity last December had invited both the quadripartite and the One Health High Level Panel to taken into account their work, social determinants of health and socioeconomic inequities between developing and developed countries, particularly health inequalities, as well as equity and solidarity.

Several questions were raised on the specificities of the two phrases used in Articles 4 and 5 respectively: “integrated surveillance” and “one health surveillance”. It seems neither the Member States nor the Secretariat had satisfactory answers. Clarification is also sought on what the “interface between human, animal, and environment ecosystems” would mean in practice. Should every household which has backyard poultry or domestic pets be kept under surveillance?

Another delegate told TWN that the Secretariat stated that integrated surveillance has a broad scope, while one health surveillance is more focussed on preventing zoonosis. It was learnt that the Secretariat had made a presentation touching upon some of these issues and also stated that International Health Regulations surveillance is limited to detection of unusual events, i.e. about diseases that are already occurring. In the pandemic instrument, it was said, surveillance is about prevention and about diseases yet to happen and preventing them. This requires routine surveillance and sharing of biological materials and environmental samples, according to the Secretariat.

It was learnt that the E.U. has proposed mapping of certain particular geographical areas that require particular surveillance. Several non-state actors have already invested in establishing hotspots in developing countries to collect biological resources and transfer them to developed country analytic centres in the name of One Health approach.

This led to several developing countries asking questions relating to the One Health approach and its implication for access and benefit sharing (ABS). The Secretariat, on the other hand, apparently attempted to downplay the discussions on implications of One Health for ABS by saying it is irrelevant to the discussions. However, developing countries pointed out the fact that the Bureau’s text proposes to share pathogens and their sequence information within the context of One Health and this must be accompanied with due commitments to benefit sharing.

Article 12: Access and Benefit Sharing (ABS)

The informal consultation led by Australia and Ethiopia has stayed away from textual discussions although the major argument of Africa Group wanted to see their text to be incorporated into Bureau’s text and form the basis of negotiations. It was said that their text proposals can effectively address the concerns raised by E.U. and U.S. Africa Group seems conveyed that proposals from E.U. and U.S. cannot do that because their models delink access and benefit sharing in various ways and do not treat “access to pathogens and their sequence information” and “sharing of benefits arising from their use” on an equal footing.

The co-facilitator from Australia was keen to address conceptual questions and circulated tabular sheets for comparing the ABS ideas from the Africa Group, Bangladesh, the E.U. and the U.S. The co-facilitators further invited questions to bring more clarity on the ABS proposals. Several countries such as Canada, Japan, the U.S., India, the Africa Group, the E.U. have raised numerous questions touching upon some of the key issues:

• Determination of pandemic potential pathogens and scope of materials and information to be shared under the ABS proposals
• Relationship between National legislation on ABS and the proposed WHO Pathogen Access and Benefit Sharing (PABS) System
• Benefits to be shared under PABS System
• How to ensure participation from States and Industries to cooperate with PABS
• Need for Accountability and Transparency
• Consistency with “Open Science” Approaches
• Ensuring legal certainty for access and benefit sharing
• Relationship with existing institutions and networks such as WHO Bio-Hub and GISRS (WHO Global Influenza Surveillance and Response System).

 E.U.’s Benefit Sharing proposals fails to gather support

The E.U.’s major proposal for benefit sharing was two-fold: (i) setting aside of a percentage of production of health products such as vaccines, therapeutics and diagnostics developing using PABS resources, (ii) tier-pricing of such products for lower-middle-income countries and other countries etc.

These proposals were in sharp contrast with what developing countries are seeking in terms of benefit sharing as well as the mode to ensure benefit sharing. Firstly, developing countries, among other benefits listed in their proposals, want two key benefits to be shared: (1) donations to WHO for distribution to vulnerable populations and (2) licences to WHO for sub -licensing production to manufacturing entities in developing countries for the diversification of production.

Secondly, developing countries want to operationalize ABS through the WHO Coordinated Network of Laboratories and Standard Material Transfer Agreements, including data use conditions, entered between WHO and users of PABS resources such as manufacturers and product developers.

The E.U., on the other hand, proposed that high-income countries (HIC) which have capacities to purchase the health products will operationalize benefit sharing to LMICs through the purchase agreements HIC make with manufacturers or the health products.  The E.U. failed to gather support both from developing countries and other developed countries.

Many developed countries asked for more details on how the E.U. would operationalize benefit sharing through the agreements they make with manufacturers. Whether this will require transparency conditionalities about publishing the purchase agreements. Many developed countries are not keen to take up such an obligation.

Developing countries, on the other hand, asked the E.U. how their proposals are equitable and fair. Why should developing countries cooperating with WHO wait for HIC’s charity to receive what they are legally entitled to receive otherwise? Further, developing countries pointed to recently published COVID-19 purchase agreements that the South African government had entered into with various pharmaceutical companies and questioned the feasibility of tier pricing.

When countries asked how “stock set asides” and “tier pricing” will solve the issues associated with equitable access which is mainly due to concentration of production in developed countries and the resultant shortage of supply, the E.U. remained silent.

TWN further learnt that the E.U. and the U.S. had stated that there are several health products and technologies that do not require access to pathogens for development and therefore access and benefit sharing is not a solution to equity. Developing countries invited the E.U. and the U.S. to work constructively in designing the measures addressing such health products, in addition to what developing countries seek through ABS mechanisms and that would broaden the scope of, as well as strengthen, the WHO PABS model.

Article 11: Access to Technology

The co-facilitators from Colombia, the Philippines and Saudi Arabia proposed a few questions for the discussion, starting with a question on whether there is a need for an article on access to technology in the pandemic instrument. There were also questions on how such provisions on access to technology can address the need for equity, and impact the availability and affordability of medical countermeasures. Discussions also extended to the need to address intellectual property in the provision and also about the possibility of actually creating an obligation for technology transfer that is effective without entering into debate between voluntary and non-voluntary technology transfer.

This was the first time Article 11 was also taken into informal discussion. Developing countries stated that access to technology is crucial for diversification of production and rapid response to pandemics, referring to numerous reports including that of the Independent Panel for Pandemic Preparedness and Response. They questioned the traditional stance developed countries take that intellectual property protection is the incentive for innovation by referring to the huge R&D funding of developed countries and the advance purchase commitments of vaccines and other health products during the COVID-19 pandemic response.

It was also learnt that developing country cited the UNCERD decision condemning the U.S., Germany and Switzerland, for their failure to waive intellectual property protection for COVID-19-related products such as vaccines. The impact of this decision of the UN Committee on Elimination of Racial Discrimination (UNCERD) on equitable access was timely and helpful in the debates.

Developing countries also used the discussion to show the importance of the designated manufacturing facilities in certain developing countries that could trigger production of pandemic-related products at the request of WHO and WHO PABS system to address the issues relating to transfer of technology in a fair and proportionate manner.

Developing countries also stated that their proposals do not obligate developed countries to force their private sector to transfer technologies. Their proposals merely enable circumstances and build effective mechanisms like PABS that can ensure access to technologies to developing countries so as to address specific issues such as inequitable access to health products during health emergencies.

Several developing countries delegations told TWN that developed countries are delaying the discussions and sometimes by asking the same questions even when these proved irrelevant. Often, developed countries tried to call out developing countries, especially the Africa Group and their proposal on PABS, and asked them how WHO PABS will address issues associated with products and technologies that do not use pathogens or sequence data in the development. Developed countries argued that the WHO PABS proposal is a very narrow approach and told developing countries that they should not rely on PABS to achieve equity in pandemic instruments.

The Africa Group replied that WHO PABS is only one of their proposals to achieve equity and there are several other provisions and mechanisms proposed by the Group as well as other Member States including developed countries, which INB should be considering for making the pandemic instrument effective and equitable in addition to PABS.

Developed countries however argue that the mechanisms and provisions proposed by developing countries are complex and transactional and thereby not effective in addressing pandemics promptly. This is the reason why the detailed proposals made by developing countries should not be there in the INB negotiating text. At the same time, some of them think their proposals for integrated surveillance and one health surveillance mechanisms (which are complex and massive), as well as access to health products to developing countries through the agreements between HIC and product manufacturers (which are transactional and non-transparent) are the ways to deliver equity in pandemics. They want such proposals in the negotiating text.

Article 9: Research and Development

The co-facilitators from Mexico and Norway were the first ones who started the informal consultations in a pilot mode during the INB drafting group meeting in June and hence Article 9 has been discussed multiple times.

The INB Drafting Group decided that there is no longer need to have informal discussions and the co-facilitators will forward a report to the INB Bureau who is preparing the new text proposal for the consideration of INB. This report will include a text streamlined by the co-facilitators as well as some indications as to points of convergence and divergence.

Several countries like the U.S., Malaysia, Japan and the U.K. as well as the Africa Group and  the E.U. had textual proposals on Article 9. Compared to other articles, the divergences are seemingly limited – both developed and developing countries explicitly recognize the need for coordination in R&D although for different purposes.  This led to confidence building in the informal group as to allow the co-facilitators to provide inputs to the Bureau’s text without much discussion.

However, the U.K. provided a last-minute streamlining of paragraphs 4, 5, and 6 of Article 9 and said that it substantially alters no obligations from the existing drafts and co-facilitators wanted to adopt the same.

However, it was pointed out that the U.K.’s proposal attempts to make clinical trial coordination as the central idea of the provision, while there are several other proposals under Article 9 that speak about R&D coordination in general such as transparency regarding research funding etc. Countries like Malaysia have requested for engaging WHO’s Global Observatory on Health R&D, and the establishment of a scientific committee to strategize on the global R&D priorities. Bangladesh reportedly pressed for having an inter-governmental nature to the said scientific committee.

The co-facilitators later agreed to report to the Bureau in a comprehensive manner – about divergence and convergences they observed in the informal meetings.

Article 13: Global production and distribution system (supply chain and logistics)

The co-facilitators from Indonesia and Pakistan remained completely respectful of Member State text proposals and merely compiled their submissions in the order of supply chain events and activities starting with assessment of demand to last-mile delivery. The proposals were reorganised under the following 4 sections: (i) Chapeau, (ii) Mechanism (Sub-sections: Demand, Production, Procurement, Allocation, Distribution, and Logistical Support / Last Mile Delivery), (iii) Governance / Modalities, and (iv) Principles. This led to some convergence between developed and developing countries.

Initially, there was an attempt to exclude the obligations on production and distribution from the pandemic instrument and request Member States to simply rely on a medical countermeasure platform developed by WHO as a programme or initiative. However, developing countries resisted.

The major demand that developed countries like Bangladesh and the Africa Group raised was to recognize the importance of the production and distribution in the Bureau’s text, and not just supply chain logistics. This was later recognized by countries like Japan, although there still remains a thought that perhaps production should be addressed in Article 11, along with technology transfer or in Article 9 along with R&D coordination.

Nevertheless, the informal discussions on Article 13 made it clear to INB Member States as to why the new pandemic instrument should address the issues associated with equitable access to health products such as vaccines, diagnostics and therapeutics through end-to-end coordination mechanism under the aegis of the WHO Member States.

Next Informal Meetings of INB drafting Group

15 September:

09:00 – 12:00 Informal meeting on Articles 4 (Pandemic prevention and public health surveillance) and 5 (Strengthening pandemic prevention and preparedness through a One Health approach)

14:30 – 16:30 Informal meeting on Article 12 (Access and Benefit sharing)

16:30 – 18:30 Informal meeting on Article 11 (Co-development and transfer of technology and know-how)

18 September

13:30 – 15:30 Informal meeting Article 11

15:30 – 18:00 Informal meeting on Articles 4 and 5

Originally published by Third World Network: https://twn.my/title2/health.info/2023/hi230902.htm

Call to action: Share this article so people around the world know they do not have to agree to anything proposed or negotiated through the WHO. It is time countries exercise their rights to real health, free speech and sovereignty. #ExitTheWHO before facing another unscientific and inhumane lockdown.