06 Feb The ‘Negotiating Text’ of the new WHO Treaty on Pandemic Preparedness and Response: An Initial Analysis and Underexamined Points of Concern
[Amrei Müller is an Assistant Professor/Lecturer (Ad Astra Fellow) at University College Dublin, Sutherland School of Law.
Dr. Silvia Behrendt is the founder and director of the Global Health Responsibility Agency.]
The Intergovernmental Negotiation Body (INB) at the World Health Organisation (WHO) issued the ‘Negotiating Text of the WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response (WHO Pandemic Agreement, the Negotiating Text henceforth)’ on 30 October 2023.
After a brief overview of the ongoing processes to negotiate a new WHO Pandemic Agreement and the parallel process of amending the 2005 International Health Regulations (IHR), this post offers an initial analysis of some of the proposed provisions of the Negotiating Text. We discuss a select number of draft provisions showing that the treaty follows a biomedical and securitised approach to pandemic preparedness and response, further entrenching the responses that the WHO, its member states and the WHO’s public-private partnerships (PPPs) have adopted in their response to the Covid-19 Public Health Emergency of International Concern (PHEIC) in international health law. We also show how these proposals will build on and strengthen various programmes that the WHO has already been implementing over the past years, reflecting this same approach. This leads us to a brief discussion of two underexamined points of concern: the absence of any engagement with the danger that the WHO Pandemic Agreement may incentivise the conduct dangerous gain-of-function (GoF) research on what the Negotiating Text refers to as ‘pathogens with pandemic potential’ (Art.1(h)); and the rather limited engagement with the implications that the Agreement may have for the enjoyment of human rights of people around the world.
The Processes so far and the Processes Ahead
To recall, the Second Special Session of the World Health Assembly (WHA) took the decision to negotiate a new multilateral treaty on pandemic preparedness and response in December 2021. The tight schedule for negotiations envisages the delivery of a final version of the Pandemic Agreement for adoption at the 77th WHA in May 2024 in accordance with Article 19 of the WHO Constitution, and a subsequent opening for signature and ratification by WHO member states and regional integration organisations like the EU (Art.31 Negotiating Text). However, considerable disagreements and frictions have emerged among WHO member states in their reactions to the Negotiating Text, the process itself – as led by the INB – has been heavily criticised by many countries, and it appears that currently, numerous WHO member states question the feasibility of complying with this tight schedule. Suggestions are floating to adopt an ‘Accord-Lite’ by May 2024, without any of the contentious provisions.
At the same time, the parallel process of revising the 2005 IHR is on-going, which, following an equally tight schedule, should be brought to completion by May 2024. The authors have analysed this process back in February 2023. The relationship between these two processes and their outcomes remains unclear. Given the considerable substantive overlap between them, the considerable resources that WHO member states, the WHO Secretariat and its PPPs invest in these processes and the tight schedules for completion, it is remarkable that – apart from holding a joint session of the INB and the Working Group on the Amendments of the IHR in July 2023 – this relationship has still not been clarified.
Nonetheless, despite recent difficulties in the on-going negotiations, the drafting process of the WHO Pandemic Agreement and the process of amending the IHR are officially scheduled to continue in February 2024 and be brought to an end in May 2024.
The Negotiating Text
Overall, the Negotiating Text follows a biomedical and securitised approach to pandemic preparedness and response. That is, it is led by the doctrine of Global Health Security (analysed by the authors, others and, more generally) and thus promotes constant global biomedical surveillance, preventive R&D on pathogens with pandemic potential, routine emergency authorisations of investigational vaccines or therapeutics for global administration and the transformation of the WHO towards a global procurement and distribution agency for pandemic products, in particular vaccines. The Negotiating Text thus appears to conclusively leave behind traditional, time-tested and more holistic approaches to the management of infectious disease outbreaks that have been relied on by the WHO before the Covid-19-PHEIC, e.g. in the 2019 WHO Non-pharmaceutical Public Health Measures for Mitigating the Risk and Impact of Epidemic and Pandemic Influenza and in domestic public health guidelines (p.70) on the response to infectious disease outbreaks. The draft provisions of the Negotiating Treaty examined in the following reflect the main components of the biomedical approach and its envisaged domestic and international institutions.
The Envisaged Global Bio-surveillance System
The Negotiating Text foresees the building of a global bio-surveillance system with international (WHO) and domestic components. In short, the draft treaty envisages that each state builds up laboratory capacities that then work together as a global network through which they can identify emerging and re-emerging pathogens, determine and share the genetic sequence data of these pathogens and inform the WHO and other member states about them.
Draft Art.4(3) of the Negotiating Text for example requires states
… to strengthen and maintain public health laboratory and diagnostic capacities, especially in respect of the capacity to perform genetic sequencing, data science to assess the risks of detected pathogens and to safely handle samples containing pathogens, and the use of related digital tools.
The so-called ‘One Health’ concept is central to the proposals surrounding the building of a global bio-surveillance system. Under draft Art.4(5) of the Negotiating Text,
Each Party shall develop, strengthen and maintain capacity to carry out integrated public health surveillance, including in respect of infectious diseases in humans, and animals that present significant risks of zoonotic diseases spill-over.
Draft Art.5(2) of the Negotiating Text further indicates that
The Parties shall promote and enhance synergies between multisectoral and transdisciplinary collaboration at the national level and cooperation at the international level, in order to identify and conduct risk assessments at the interface between human, animal and environment ecosystems, while recognizing their interdependence […].
It thus implies a constant bio-surveillance of the ‘human-animal-environment’ interface on a global scale, including the building up extensive genomic sequencing capacities, in line with the expansive ‘One Health’ concept. State parties shall then share pathogens with pandemic potential as well as genomic sequences through a global laboratory network which shall be built on already existing or newly created arrangements (Art.6(4)).
The WHO has previously encouraged its member states to build domestic genomic surveillance systems in its ‘Global Genomic Surveillance Strategy for Pathogens with Pandemic and Epidemic Potential, 2022–2032’ and its related national surveillance and sharing strategies that are already implemented at the national level.
The Negotiating Text provides for the establishment of a ‘WHO Pathogen Access and Benefit Sharing System’ (WHO PABS System) in draft Art.12. This system is intended to ensure timely global access (Art.12(2)) to so-called ‘PABS material’ (defined in Art.1(m)), i.e. pathogens with pandemic potential and their genetic sequence data; and subsequently, global equal access to potential pandemic products developed based on shared biological material and genetic sequences. Via the WHO PABS System, the contracting parties should provide PABS material to a laboratory network coordinated by the WHO and feed the genetic sequence data of this material into a publicly accessible database, provided that this database has made appropriate arrangements for handling data on PABS material (Art.12(4)(a)(i)). In addition, states should use Standardised Material Transfer Agreements to ensure that the transfer of PABS material is in line with the transferring state’s duties under 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 thereto (Art.12(8)) and in accordance with biosafety regulations (Art.12(4)(a)(iii)). It can also be noted that the WHO has already started to set up a global system – the WHO BioHub system – through which it collects biological material with pandemic potential and respective gene sequence data. Manufacturers of pandemic products using the biological material shared via the PABS System shall not be entitled to obtain any intellectual property rights on PABS materials (Art.12(4)(a)(iv)), and shall be obliged – in the event of a pandemic – to give real-time access ‘to a minimum of 20% (10% as a donation and 10% at affordable prices to WHO) of the production of safe, efficacious and effective pandemic-related products for distribution based on public health risks and needs […]’ (Art.12(4)(b)(ii)(a)).
The planned WHO PABS System is one of the most contentious issues in the on-going negotiation process. The lines of contention revolve around, on the one hand, the fear of low-income countries that they will be under an obligation to share biological material through the above-discussed extensive duties on domestic bio-surveillance systems that submit biological material to the WHO, without, in fact, getting timely access to affordable pandemic products developed by manufacturers in high-income countries relying on this material. On the other hand, high-income countries appear to criticise the system as incompatible with their economic interests and intellectual property law, or rather, the interests of the pharmaceutical industries located within their jurisdiction.
R&D on Pathogens with Pandemic Potential
The Negotiation Text of the Pandemic Treaty also envisages an expansion of research and development activities on pathogens with pandemic potential and ‘pandemic-related products’. Draft Art.9 – a lengthy provision – is most relevant in this context.
In essence, it aims to commit states to build, strengthen and maintain capacities and institutions for research and development of pandemic-related products (Arts.9(1) and (2)(a) and (c)), as well as to increase capacities, infrastructure and networks for the rapid conduct of clinical trials, the sharing of results from these trials and to strengthen the policy framework for clinical trials (Art.9(3)). States shall also fund such activities in a sustainable fashion (Art.9(2)(a) and (3)).
Such provisions will support the WHO’s own pre-emptive R&D activities in relation to pathogens with pandemic potential that it has built up since 2014 under its Research and Development Blueprint for Emerging Pathogens (R&D Blueprint) Programme. The programme ‘allows [for] the rapid activation of research and development activities during epidemics’ [or rather, as soon as the WHO Director-General declared a PHEIC under Articles 12(1) and 1(1) of the IHR, or potentially during a pandemic] aiming to ‘fast-track the availability of effective tests, vaccines and medicines that can be used to save lives and avert large scale crisis,’ and to thus ‘reduce the time between the declaration of a PHEIC and the availability of effective tests, vaccines and medicines’. It does so not only through activating a rapid R&D plan once a PHEIC has been declared but also by commissioning R&D on pathogens with pandemic potential before a PHEIC occurs under the pretext of R&D preparedness.
Routine Emergency Authorisations of Experimental Medical Products for Global Use
Draft Articles in the Negotiating Text aim to ensure that states have the regulatory framework in place to grant fast-track emergency authorisation for investigational medicinal products during a pandemic. Draft Art.14 on ‘regulatory strengthening’ inter alia envisages that states
- ‘strengthen their national and regional regulatory authorities, including through technical assistance, with the aim of expediting regulatory approvals and authorizations and ensuring the quality, safety and efficacy of pandemic-related products.’ (Art.14(1));
- ‘… publicly disclose information on national and, if applicable, regional processes for authorizing or approving use of pandemic-related products, and any additional relevant regulatory pathways for such pandemic-related products that may be activated during a pandemic to increase efficiency, and update such information in a timely manner;’ (Art.14(4)) and
- ‘take steps to ensure that it has the legal, administrative and financial frameworks in place to support emergency regulatory approvals for the effective and timely regulatory approval of pandemic-related products during a pandemic.’ (Art.14(5))
In effect, this would likely mean that all states shall set up procedures at the domestic level that are comparable to the US Food and Drug Administration’s (FDA) emergency use authorisation procedure, or the European Medical Agency’s (EMA) conditional marketing authorisation procedure for pandemic-products.
These envisaged regulatory changes in the domestic legal orders of states that may ratify the treaty will be complemented also by WHO’s already existing own procedure for granting de facto emergency authorisations for investigational medical products during a PHEIC as declared under the IHR: the Emergency Use Listing (EUL) procedure. The EUL procedure can be activated once the WHO Director-General declared a PHEIC, or in cases where he is of the opinion that it is in the best interest of public health to use the procedure in a public health emergency (PHE) situation that does not meet the criteria of a PHEIC. In the WHO’s words (p.7), the
EUL is a special procedure for [assessing and listing] unlicensed vaccines, medicines and in vitro diagnostics in the event of a PHE when the community/public health authorities may be willing to tolerate less certainty about the efficacy and safety of products, given the morbidity and/or mortality of the disease and the lack or paucity of treatment, diagnosis/detection or prevention options.
It aims to ‘expedit[e…] the availability of these [medical] products to people affected by public health emergency’ on a ‘time limited [preliminary] basis while further data is being gathered and evaluated’.
During the Covid-19-PHEIC, the WHO granted EULs to all known investigational vaccines against Covid-19. Among other things, this enabled the WHO to promote, distribute and administer these vaccines worldwide through its PPPs, especially GAVI and COVAX. The draft provisions of the Negotiating Text do not explain how emergency approvals in domestic law shall relate to the WHO’s existing own EUL procedure.
Rapid Global Prroduction, Procurement and Distribution of Pandemic Products
Another part of the predominant biomedical approach to pandemic preparedness and response to be strengthened by the planned pandemic treaty concerns the rapid production, procurement and distribution of pandemic products which the WHO considers are needed to address a pandemic.
There are various provisions in the Negotiating Text that envisage transforming the WHO into a global procurement and distribution agency for pandemic products. In addition to relevant draft Art.12(4)(b)(ii)(a) on the WHO PABS System mentioned above under a), there is, for example, draft Art.13 of the Negotiating Text on the establishment of a ‘Global Supply Chain and Logistics Network’ (the WHO SCL Network) which shall ensure global equal access to pandemic products. The WHO SCL Network shall
(a) estimat[e…], or, where possible, determin[e…], the most likely types and size/volume of products needed for robust pandemic prevention, preparedness and response, including the costs and logistics for establishing and maintaining strategic stockpiles of such products;
(b) assess[…] the anticipated demand for, mapping the sources of and maintaining a dashboard of manufacturers and suppliers, including surge capacities and relevant necessary raw materials, for the sustainable production of pandemic-related products;
(c) identify[…] the most efficient multilateral and regional purchasing mechanisms, including pooled mechanisms;
(d) work[…] with national authorities to establish and maintain national and/or regional stockpiles of various pandemic response-related products, as well as maintain[…] the relevant logistic capacities and assess[…] them at regular intervals, and specify[…] the criteria to ensure that stockpiling is used only to address public health needs;
(e) facilitat[e…] the negotiation and agreement of advance purchase commitments and procurement contracts for pandemic-related products;
(f) promot[e…] transparency in cost, pricing and all other relevant contractual terms along the supply chain;
(g) coordinat[e…] to avoid competition for resources among procuring entities, including regional organizations and/or mechanisms;
(h) map[…] existing, and identify[…] needed, delivery and distribution options;
(i) establish[…] or operationaliz[e…], as appropriate, international or regional stockpiles, consolidation hubs and staging areas;
(j) assist[…] buying countries in meeting the logistic requirements for the utilization of specific pandemic-related products; and
(k) facilitat[e…] or, as necessary, organizi[e…] the efficient delivery and appropriate utilization of pandemic-related products in beneficiary countries or in humanitarian settings.
The WHO SCL Network will only work if states are also obliged to establish or expand their production and distribution capacities for pandemic products at the national level and allow the transfer of technology and know-how to produce pandemic products to low-income countries. Draft Art.11 is relevant here, indicating inter alia that states shall ‘facilitate and incentivize the manufacturers of pandemic-related products to transfer relevant technology and know-how to manufacturer(s) on mutually agreed terms as appropriate, […] and to address the need to develop new pandemic-related products in a short time frame’ (Art.11(2)(a)); to make use of the flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) (Art.11(2)(c)); and to ‘develop a database that provides the details of pandemic-related products for all known pandemic-potential diseases, including the technological specifications and manufacturing process documents for each product’ (Art.11(2)(e)). Moreover, states shall, during a pandemic, ‘agree upon […] time-bound waivers of intellectual property rights to accelerate or scale up the manufacturing of pandemic-related products to the extent necessary to increase the availability and adequacy of affordable pandemic-related products’ (Art.11(3)(a)). Once more, these draft provisions are among the contentious provisions criticised by low and high income countries for different reasons.
The draft Negotiating Text also obliges states to control information during a pandemic. Under draft Art.18(1) on ‘Communication and Public Awareness’ states shall ‘combat false, misleading, misinformation or disinformation, including through effective international collaboration and cooperation’. To enable such ‘infodemic management’, states shall
[…] conduct research and inform policies on factors that hinder adherence to public health and social measures in a pandemic and trust in science and public health institutions.
The Negotiating Text also contains a definition of ‘infodemic’. According to draft Art.1(c)
„infodemic” means too much information, false or misleading information, in digital and physical environments during a disease outbreak. It causes confusion and risk-taking behaviours that can harm health. It also leads to mistrust in health authorities and undermines public health and social measures.
With this, the Negotiating Text adopts the definition of ‘infodemic’ that one can find on the WHO’s website informing about the Infodemic Management programme which has been active during the Covid-19-PHEIC. Through this programme, the WHO in collaboration with Big Tech companies (such as Facebook), media (such as Youtube) and fact-checking organisations and governments pre-bunk, de-bunk and censor or otherwise remove health information that the WHO regards as mis-, dis- or false information.
Despite the numerous open questions around how ‘false, misleading, misinformation or disinformation’ are defined and distinguished, how they are identified, on what basis and by whom, it appears that no controversies or disagreements have arisen so far among the states involved in the drafting process around these draft provisions.
Underexamined Points of Concern: The Potential Incentivisation of Dangerous Gain-of-function Research and Human Rights
As mentioned, some of the above-described components of the biomedical and securitised approach to pandemic preparedness and response and its institutions have been criticised by different states and private actors involved in the negotiations for various reasons. Disagreements largely revolve around the question of ensuring equal access to pandemic products, and in particular to vaccines, and related economic and financial questions.
There is, however, no deeper questioning of the bio-medical and securitised approach to pandemic preparedness and response, focusing exclusively on extensive bio-surveillance and the rapid development, licensing, distribution and administration of pandemic products, first and foremost with the aim to carry out renewed global mass vaccination campaigns as during the Covid-19 PHEIC. It appears, that few questions are asked about the actual effectiveness of such a global one-size-fits-all approach, the significant biosafety and biosecurity concerns it raises and its wider implications for the enjoyment of human rights.
Incentivising Highly Dangerous Gain-of-function Research on Pathogens with Pandemic Potential?
One concern not examined in the negotiations is the danger that an ever tighter biomedical global surveillance system encompassing also the ‘human-animal-interface’ in line with the ‘One Health’ concept, the wide sharing of pathogens with pandemic potential and their genetic sequences and ever more R&D on these pathogens may well increase the conduct of highly dangerous GoF-research. GoF-research implies that scientists use a variety of techniques to make viruses more pathogenic (i.e. they increase the severeness of the illness they cause) and/or to make them more transmissible. The common justification for such research is that scientist must ‘get ahead of nature’ to predict what might be future pandemic threats, and to develop vaccines against such threats. The dangers of this type of research have been recognised by concerned scientists who have called for very strict control of, moratoria on the conduct of or full prohibition of GoF-research.
Among the dangers is first that viruses that may have been bioengineered for prophylactic purposes may escape from laboratories. And indeed, there have been countless reports over the years that bioengineered viruses did escape or otherwise originated from labs. There is mounting evidence that SARS-CoV-2 itself was the result of GoF-research examining the spillover potential of SARS-like viruses which was funded by the US National Institutes of Health (NIH) and in particular the National Institute of Allergy and Infectious Disease (NIAID) via the EcoHealth Alliance at the Wuhan Institute of Virology, including mounting evidence obtained via Freedom of Information Act (FOIA) requests in the US that those involved try hard to cover up the lab origin of SARS-CoV-2, inter alia by labelling any information about it ‘disinformation’ or a ‘conspiracy theory’.
Second, GoF-research falls into the category of dual-use research and can thus be employed to turn ordinary or pathogenic viruses or bacteria into biological weapons. Indeed, in the US, the leading nation conducting GoF-research, funding for research on natural pandemics and steadily growing biological defence funding have long been lumped together, and civilian and military departments and institutions are brought together under the Public Health Emergency Medical Countermeasures Enterprise, overseeing ‘research, advanced research, development, procurement, stockpiling, deployment, distribution and utilisation’ of medical countermeasures (i.e. therapeutics and vaccines) to address health emergencies occurring naturally, accidentally or intentionally. Such lumping together may contradict the 1925 Geneva Gas Protocol and the 1972 Bioweapons Convention (BWC) which prohibits any GoF-research for the development of any defensive or offensive bioweapons (preamble read in conjunction with Art.1(1) BWC). The BWC does not, however, prohibit research with ‘microbial or other biological agents’ that is for ‘prophylactic, protective or other peaceful purposes’ (Art.1(1) BWC).
Various draft provisions in the treaty may encourage this dangerous GoF-research, and may feed new and emerging pathogens with pandemic potential into existing GoF-research projects conducted in the increasing number of biosafety level 3 (BSL-3) and BSL-4 biolaboratories around the world. As already mentioned, many of the draft Articles aim at establishing and expanding a global network of biolaboratories with genomic sequencing capabilities in states parties to the treaty (Arts.1(a), (b) and (i), 4(3), 5(7), 6(2)(f) and (4) as well as 12(4)(a) Negotiating Text). This includes obligations to assess the risks of the pathogens detected via the network of laboratories (Arts.4(3) and 6(4)), and to conduct and accelerate ‘innovative research and development’ (Art.9(2)(c)) to address pathogens with pandemic potential. This does not exclude GoF-research which manipulates the pathogenicity and transmissibility of viruses with pandemic potential, allegedly to then develop vaccines against such bioengineered pathogens. An earlier version of the draft Pandemic Agreement (of 2nd of June 2023) still included a draft provision explicitly encouraging states to ‘carry out research to better understand the pathogenicity and transmissibility of pathogens with pandemic potential […] and to minimis[e…] unnecessary administrative hurdles for research’ (Art.9(5)) which has, however, been removed from the Negotiating Text. Whilst the Negotiating Text also includes draft provisions that oblige states to ‘strengthen laboratory biosafety and biosecurity, […] in order to prevent the accidental exposure, misuse or inadvertent laboratory release of pathogens’ (Arts.4(4)(f), 6(2)(f) and 9(2)(c)), the history of frequent leaks even at laboratories that are considered the safest worldwide does not inspire confidence that a further increase in the number of biolabs around the world contributes to the prevention of pandemics, but could, in fact, rather do the opposite. This has been recognised in a 2022 publication ‘COVID-19: A Warning’ by UN Environment Programme (pp.21-22 and 36), calling for a better regulation or ban of GoF-research, calls that have been made by concerned scientists before (as mentioned above). In a March 2023 Hearing before the US Congress on COVID origins, the former director of the US Centre for Disease Control and Prevention, Robert Redfield, also highlighted that decades of GoF-research conducted by US civil and military research institutions have not led to the development of beneficial drugs or vaccines, an observation that converges with the observation of critical scientists that the benefits of GoF-research have long been overstated. Moreover, as mentioned, GoF-research likely violates states’ duties under the BWC.
Those involved into the negotiations of the Pandemic Agreement and the amendments of the IHR should take explicit notice of this danger and may want to include a clear prohibition of highly dangerous GoF-research into the Agreement and the IHR amendments, and/or simultaneously embark on the tedious but important process to reinvigorate a review process of the BWC. Such a process may aim to remove the exception from Art.1(1) BWC. At the same time, a truly independent international institution – e.g. an international Organisation for the Prohibition of Biological Weapons – would need to be established to effectively supervise and control the implementation of a global prohibition of GoF-research as had been foreseen in the planned verification Protocol to the BWC of the early 2000s. After long negotiations in the 1990s, the Protocol had to be abandoned in 2001 after the US unexpectedly declared that it had no intention to sign and ratify the Protocol (discussed also here). Such an approach would, in addition, address the highly likely root cause of the Covid-19 pandemic.
Overlooked Implications for the Enjoyment of Human Rights
Another related, under-discussed matter in the negotiations of the Pandemic Agreement are the effects of the securitised biomedical approach to pandemic preparedness and response on the enjoyment of human rights. Whilst there have been human rights organisations and academic commentators criticising the various versions of the draft Pandemic Agreement/IHR amendments for their lack of attention to human rights and in particular the right to health (see here, here, here, here, here and here), this criticism mostly centres on the fact that they will not ensure rapid equal access of every human being to pandemic products, including investigational vaccines (see e.g. statement by Human Rights Watch). Whether such approach – wishing to treat everyone on the planet with the same investigational medical product, no matter where they live and what their personal health status is – is medically sound, a reasonable use of scarce health resources in particular in low-income countries and will indeed promote the enjoyment of the human right to health, can reasonably be questioned.
The biomedical and securitised approach is thus not as such questioned by human rights organisations and academic commentators and not raised in the negotiation process, notwithstanding the negative impact such an approach had on the enjoyment of human rights during the Covid-19 PHEIC. It also means that questions concerning the safety and effectiveness of pandemic medical products – developed in rapid R&D processes (with the plan going towards development within just 100 days) and emergency authorised/listed – and their potentially negative consequences for the enjoyment of the human rights to life and health are neither raised nor discussed. In this context, it can be recalled that the right to health is not only a right to access essential medicines, but to access safe and effective medicines, even during a WHO-declared PHEIC.
If, in addition, securitised and biomedical strategies are pushed on individuals around the world through indirect or direct coercion, as it was the case in many countries during the Covid-19 PHEIC, this can lead to violations not only of states’ duties under the rights to life and health, but also under the rights to work, to freedom of movement, to privacy, to participate in cultural and political life, not to be discriminated against, etc. of those who refuse taking an investigational vaccine (recognised, to some extent, here). During the Covid-19-PHEIC, such contentious policies were rarely questioned, even though they had no factual basis as it was known right from the beginning that the promoted Covid-vaccines did neither prevent people from catching Covid-19 nor from transmitting it (p.132). Moreover, a recent re-analysis of the original clinical trials conducted by Pfizer and Moderna, shows that these vaccines could not easily be categorised as ‘safe’.
Thus, whilst the Negotiating Text of the Pandemic Agreement includes a draft provision that encourages states to set up compensation schemes for the vaccine injured (Art.15), there is little on how states, the WHO or regional institutions like the EMA shall ensure that rapidly developed investigational vaccines are indeed safe and effective – even if they are emergency licenced or listed – or that they shall meticulously record and monitor adverse events resulting from the global administration of emergency licenced/listed medical products, and that they shall withdraw such products once reported adverse events reached a critical level. A glance at the US, EU and WHO databases recoding adverse events after Covid-19 vaccinations raises questions as to whether safety signals that occurred (and still occur) during the global rollout of the Covid-19 vaccines have been adequately heeded to. Including such provisions in the Pandemic Agreement and/or the amended IHR is essential to effectively protect the human rights to health and life, including the right to have access to safe and effective medical products. Moreover, there is a need to reiterate the fundamental principle of informed consent to any medical treatment to prevent imposing direct and indirect coercive medical treatments with investigational, emergency licensed/listed or other products during a pandemic or WHO-declared PHEIC.
Last but not least, the negotiations and commentators rarely raise the question of how the envisaged provisions on ‘infodemic management’ shall be made compatible with states’ duties under the human right to freedom of expression, information and opinion. Once more, debunking, prebunking and removal of any information and debates on public health that questioned the line predetermined by the WHO during the Covid-19 PHEIC has undermined our ability to openly and critically discuss the global response to Covid-19, and to learn from such discussions. As highlighted above, among the ‘conspiracy theories’ regularly removed from public debates were also any suggestions that SARS-CoV-2 originated from a biolab in Wuhan. Entrenching infodemic management as a default mode of operation in the new Pandemic Agreement appears to be problematic also against this background.
The authors of this post wished to outline the main components that make up the biomedical, securitised approach of pandemic preparedness and response enshrined in the Negotiating Text of the Pandemic Agreement and draw attention to two important but under-discussed issues: the absence of any engagement of negotiators and commentators with the danger that the WHO Pandemic Agreement may incentivise dangerous GoF-research on pathogens with pandemic potential; and the rather limited engagement with the implications that the Agreement may have for the enjoyment of human rights of people around the world, in particular the rights to life, health and freedom of expression.
Even if negotiations of the Pandemic Agreement are stalling at the WHO, and it appears unlikely that there will be a fully negotiated treaty for states to sign and ratify in May 2024, the authors think it important to begin public discussions at WHO and within its member states about the biomedical, securitised approach to pandemic preparedness and response, ideally informing a thorough and independent critical evaluation of the WHO’s and its member states’ response to the Covid-19-PHEIC too.
Human Rights Watch has rightly described the ‘Covid-19 pandemic as both a health and human rights catastrophe’. However, there has been very little discussion about how much of this catastrophe was due to GoF-research and how much was due to WHO-recommended responses (via the Statements of its Covid-19 Emergency Committee) to the appearance of SARS-CoV-2 implemented all over the world, which followed this very biomedical, securitised approach that is promoted by both the draft Pandemic Agreement and the proposed IHR amendments. Indeed, so far, such critical analyses have at least partly been prevented by the WHO’s infodemic management programme as the Twitter Files, FOIA requests in the US and the experiences of critical academics and scientists over the last years have revealed.
Maybe it is time to halt all efforts to rapidly reform the international legal framework on PHEICs and pandemic preparedness and response until such a thorough, fully open and independent analysis has been conducted?