TWN Info Service on Health Issues (Jan22/09)
24 January 2022
Third World Network

WHO: Health emergency preparedness and response initiatives serve the interest of developed countries

New Delhi/Kochi 24 January, (K M Gopakumar and Nithin Ramakrishnan) – The WHO Director-General’s report to the Executive Board (EB) reveals that WHO’s heath emergency preparedness and response initiatives compromise principles of accountability and participatory governance, to serve the interest of developed countries.

The 150th Session of the EB is taking place from 24 to 29 January at the WHO Headquarters in Geneva in hybrid mode.

The report (EB 150/15) is mandated under resolution WHA74.7 adopted at the 7th session of the World Health Assembly. This resolution requested the Director-General (DG) to submit a report to the 75th WHA regarding the implementation progress of WHA 74.7.

According to the report, “in resolution WHA74.7, the Health Assembly, having taken note of the recommendations of reviews, including those of the Independent Panel for Pandemic Preparedness and Response, requested the Director-General to strengthen the Organization’s capacity to prepare for and respond to health emergencies in key areas”.

The report is divided into two parts. The first part reports on WHO’s initiatives to strengthen preparedness and response to health emergencies in the light of COVID-19. The second part provides the details of the WHO Secretariat’s assistance to the Member States Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (WGPR).

The report claims that in the area of health emergency preparedness and response “the Secretariat has built on the existing framework of the three outcomes for achieving the target of one billion people better protected from health emergencies”. The expected outcomes are: countries prepared for health emergencies; epidemics and pandemics prevented; and health emergencies rapidly detected and responded to.

However, various initiatives cited in the report compromise the principles of accountability and participatory governance, which in turn reinforces the status quo to serve the interest of developed countries.

There are three initiatives listed under the first two outcomes viz. countries prepared for health emergencies; and epidemics and pandemics prevented. These are:

• WHO Hub for the Pandemic and Epidemic Intelligence based in Berlin;
• WHO Bio-Hub Facility; and
• A new Scientific Advisory Group for the Origins of Novel Pathogens.

Though there’s a prefix of WHO for the first two initiatives they are not accountable to WHO governing bodies. Further, there is no approval from Member States to start these hubs.

WHO Hub for the Pandemic and Epidemic Intelligence: This was inaugurated on 1 September 2021 in Berlin. According to the WHO press release, “The WHO Hub is part of WHO’s Health Emergencies Programme and will be a new collaboration of countries and partners worldwide, driving innovations to increase availability of key data; develop state of the art analytic tools and predictive models for risk analysis; and link communities of practice around the world”.

The pandemic intelligence hub was established with the initial funding of 100 million euro from the German Government. This initiative marks a shift from the traditional diseases surveillance and laboratory results to gather information from multiple sources and following an interdisciplinary approach, to obtain a more robust understanding to enable better decision-making based on better data and analyses.

The new pandemic intelligence hub works on the basis of collaborative intelligence involving partners including the private sector. The strategy paper concerned envisages a multistakeholder decision-making mechanism in relation to the collaborative intelligence framework, including its trust architecture. This means that non-state actors including the private sector, such as pharmaceutical companies, will be on an equal footing in the decision-making of the trust architecture. It also means that the pandemic intelligence hub will not be accountable to WHO governing bodies. Furthermore, the participation of “all WHO Member States” in the public health intelligence hub is also doubtful.

WHO Bio-Hub System: This joint initiative between WHO and Switzerland was launched on 24 May 2021 i.e. ahead of adoption of Resolution WHA74.7. The Swiss government is providing the infrastructure support to the bio-hub through the Swiss biosafety laboratory in Spiez. According to the press release, “Currently, most pathogen sharing is done bilaterally between countries and on an ad hoc basis, which can be slow, and leave some countries without access to the benefits and tools. The BioHub will enable Member States to share biological materials with and via the BioHub under pre-agreed conditions, including biosafety, biosecurity, and other applicable regulations. This will ensure timeliness and predictability in response activities”.

In fact Operational Paragraph 9.15 of resolution WHA 74.7 requested the DG “to work together with Member States, the medical and scientific community, and laboratory and surveillance networks, to promote early, safe, transparent and rapid sharing of samples and genetic sequence data of pathogens of pandemic and epidemic, or other high-risk, potential, taking into account relevant national and international laws, regulations, obligations and frameworks, including, as appropriate, the International Health Regulations (2005), the Convention on Biological Diversity and the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization and the Pandemic Influenza Preparedness Framework and the importance of ensuring rapid access to human pathogens for public health preparedness and response purposes.”

WHA 74.7 was adopted after the launch of the bio-hub and there was no move from the part of the WHO Secretariat to involve the Member States and governing bodies to take a decision with regard to the architecture of the bio-hub. The Secretariat is organising a series of multi-stakeholder consultations in a way to show compliance with the WHA resolution. Though Paragraph 13 of the DG’s Report also states that “The BioHub is now at the start-up phase for sustainable pathogen-sharing, and is expected to be further developed, through its system design phase, in 2022, in consultation with Member States”, in WHO parlance the term “in consultation with Member States” does not mean that governing bodies need to approve the mechanism.

The current arrangement i.e. a Swiss biosafety laboratory, is not accountable to WHO Member States though its governing bodies.

The guiding principles of the WHO BioHub as prepared by the WHO Secretariat contains 10 principles, but do not even use the phrase “benefit sharing”. The language of benefit sharing is conspicuously absent in the commentary to the principles as well. Although the two standard material transfer agreements (SMTA) used in the BioHub (currently in pilot phase) recognize benefit sharing, the language used is very ambiguous and not indicative of how fair and equitable benefit sharing would play out in future.

For example, in SMTA 2, Article 5 that includes Biological Materials with Epidemic or Pandemic Potential (BMEPP) merely states that: “In furtherance of the aims set out in the Recitals of this Agreement, the WHO BioHub System aims to provide to all Member States and relevant partners, access to a range of public health information, tools, and products that may arise from the sharing of BMEPP with the WHO BioHub System. This Agreement covers the Pilot Testing Phase and period of the WHO BioHub System project, only, and that Pilot Testing Phase is not designed or intended to result in the creation of material benefits from the BMEPP. In the event that the use of BMEPP results in the creation of such material benefits, all Parties will engage with WHO to distribute and provide such benefits on a fair and equitable basis.”

These initiatives bypassing WHO governing bodies serves the interest of developed countries by facilitating access to pathogen samples and genetic sequence information (GSI) contrary to the corresponding obligation to share the benefits on a fair and equitable basis. Paragraph 9 of the DG’s Report states: “technologies have not only the potential to transform the speed at which we recognize and communicate threats but also the speed at which, and depth to which, we understand the natural history of infectious pathogens, their transmission dynamics, and their susceptibility over time to public health and biomedical interventions”. Thus it is clear that this pandemic intelligence hub would be dealing with data on pathogens and there is no clarification on benefit sharing with countries that are the source of the data.

Similarly, Paragraph 13 of the DG’s Report states: “This System is intended to be an essential element of a global mechanism for the standardized collection, characterization and archiving of viruses, other pathogens with pandemic potential and specimens to facilitate and accelerate the development of diagnostics, therapeutics and vaccines”. The Standard Material Transfer Agreements (SMTA) of bio-hub covers only BMEPP and not the GSI.

However, Article 3.1.3 of SMTA 1 requires the uploading of BMEPP genetic sequence data to various databases. From these databases, the sequence may be used for the development of diagnostics and vaccines, without any commitment to fair and equitable benefit sharing. Therefore any party accessing GSI from such database may not be under any benefit sharing obligation.

Under the Convention on Biological Diversity and its Nagoya Protocol on Access and Benefit Sharing, the recipients of the biological materials or their genetic sequence information are under an obligation to share the benefits of the R&D outcomes in a fair and equitable manner with the providers of such materials. Pharmaceutical companies refuse to share benefits with providers of pathogen samples and GIS and instead monopolise the products through intellectual property protection to maximise their profits. As a result, developing countries who promptly share samples of pathogen or GIS will not access the diagnostics, vaccines or therapeutics developed using such samples or GIS. WHO is reinforcing the status quo and defying the provisions of the Convention on Biological Diversity and Nagoya Protocol.

Epidemic Intelligence from Open Sources (EIOS): Paragraph 17 of the DG’s report refers to the role of EIOS in rapid detection and response to health emergencies. According to the EIOS webpage: “Creating a community of practice for public health intelligence (PHI) that includes Member States, international organisations, research institutes and other partners and collaborators is at the heart of the initiative; saving lives through early detection of threats and subsequent intervention its ultimate goal”.

It also states: “The EIOS system builds on a long-standing collaboration between WHO and the Joint Research Centre (JRC) of the European Commission (EC) to develop a system for public health intelligence and responds to the need for a global initiative to bring together PHI efforts”. The IT system functioning behind EIOS is developed under the technical lead of the JRC. EIOS has staff working in all the WHO regional offices.

The Coordination Group of EIOS does include the European Commission. Other members are the Africa Centres for Disease Control and Prevention (Africa CDC), Public Health England, Food and Agriculture Organization of the United Nations (FAO), European Commission – Joint Research Centre, Global Outbreak Alert and Response Network, European Centre for Disease Prevention and Control, The National Institute of Infectious Diseases Japan, Centres for Disease Control and Prevention (CDC, US), World Organisation for Animal Health (OIE), Ministry of Health Mexico, WHO and Public Health Agency Canada. Thus the governance is controlled by agencies of developed countries, and EIOS is not reporting or accountable to any of the WHO governing bodies.

Access to COVID-19 Tools (ACT) Accelerator: According to Paragraph 14 of the DG’s report: “WHO’s research and development blueprint for action to prevent epidemics and the three vertical product pillars of the Access to COVID-19 Tools (ACT) Accelerator provide a foundation on which to build a transparent and coordinated global mechanism whereby research and innovation priorities are set upstream”.

It further states: “WHO continues to explore with partners ways in which the successes of the ACT Accelerator can be institutionalized and built on over the coming months and years”.

ACT Accelerator, a mechanism based on the whitepaper of the Bill and Melinda Gates Foundation, was launched on 24 April 2020 to facilitate the development and equitable distribution of the tests, treatments and vaccines for COVID-19. This initiative has three pillars for vaccines, therapeutics and diagnostics. The lead organisations for the vaccine pillar are Gavi, the Vaccine Alliance, Coalition for Epidemic Preparedness Innovations (CEPI) and WHO. Wellcome Trust and UNITAID are leading the therapeutics pillar, while the Foundation for Innovative New Diagnostics (FIND) and the Global Fund are the leads for diagnostics.

Apart from the three pillars there is a Health System Connector Pillar working to ensure the tools reach the people in need. WHO also hosts the ACT-Accelerator secretariat known as ACT-A Hub. Each pillar has its own work streams with participation of industry and selected civil society organisations. Though there is an ACT-A facilitation council for governance purposes the mandate of the council is to address the strategic, policy and financial issues and political advocacy for the ACT Accelerator. There is no mandate for the council to take any substantive decision with regard to the ACT Accelerator such as the intellectual property protection of R&D outcomes or licensing of products developed through ACT-A, as this is within the purview of each pillar consisting of a few actors including certain donors.

The Act Accelerator could not make any significant impact to address the inequitable access to COVID-19 health products especially in addressing intellectual property barriers to scale up production.

As the WHO EB meets this week, Member States from developing countries needs to take full cognisance that the trend of WHO’s strengthening of preparedness and response to health emergencies favours developed countries and their pharmaceutical corporations, undermining the WHO governing bodies and accountability to Member States.