Anticipation under the human right to science (HRS): sketching the public institutional framework. The example of scientific responses to the appearance of SARS-CoV-2

ABSTRACT

This contribution sketches the domestic and international institutional framework that states shall set up to implement their anticipation duties flowing from the HRS and, at the same time, enable international organisations to comply with their anticipation responsibilities for the HRS. Building on the understanding of science as a communal and open-ended endeavour of knowledge seeking in which everyone has an equal right to participate, to benefit from and to be protected against harm arising from it, it elaborates on states’ duties under the HRS to anticipate both the (opportunities for) benefits and the (risks of) harm of science, and to promote the former and protect against the latter with due diligence. It then argues that the HRS requires domestic and international institutions working along egalitarian lines and allowing for broad participation to (co-)specify domestic anticipation duties and coordinate their implementation in context. This is essential due to the global nature of many harms and benefits of science and its communal character. The example of the scientific response to SARS-CoV-2 is used to highlight that the current domestic and international institutional framework has, however, serious shortcomings.

KEYWORDS:

• Human right to science (HRS)
• anticipation duties and responsibilities
• benefits and harm of science
• institutions
• WHO
• SARS-CoV-2

1. Introduction

This contribution argues that the biggest obstacle to the realisation of the human right to science (HRS),¹ including in particular the right to participate in and enjoy the benefits of science and its applications and the right to be protected against the adverse effects of science and its applications,² is the wide-ranging direct or indirect³ privatisation and commercialisation of the scientific enterprise⁴ as well as other pervasive forms of instrumentalisation of science. The direct or indirect privatisation appears to extend to many components of the current domestic and international institutional framework that states have set up to secure the HRS, including their anticipation duties flowing from it in the area of health and medical research and science. This seems to lead to a situation today in which scientific processes and research as well as their outcomes, benefits and applications are often directed, exploited, and otherwise influenced by powerful commercial and other private interests.⁵ Similarly, knowledge and information about the short- and long-term harm (or risks thereof) of scientific processes, applications and technologies are largely in the hands of private entities. At the same time, the indirect privatisation of ‘public’ institutions can result in the unfortunate misuse or instrumentalisation of science (or, rather, what is deemed to be ‘science’ or a ‘scientific consensus’, expressed for example in the often-repeated slogan ‘follow the science’⁶) and technology to justify technocratic-managerial, top-down approaches to govern and control local, regional and global societies to allegedly ensure ‘public health’, ‘prevent terrorism’ and offer ‘security’, implement the Sustainable Development Goals (SDGs), etc. Such approaches are adopted by domestic, regional and international institutions which technically remain public institutions, but which, to varying degrees, may have come under the influence of powerful private actors.⁷ More broadly, this reality can undermine individuals’ enjoyment of human rights other than the HRS, as well as the functioning of domestic democratic institutions through which states shall respect, protect and fulfil these rights.⁸

The (negative) example of the ongoing global distribution of investigational vaccines against Covid-19 that are based on a novel gene-based mRNA technology⁹ hailed as the ‘breakthrough of science of the year 2020’¹⁰ via domestic and international institutions to allegedly rid the world of the in all likelihood engineered¹¹ SARS-CoV-2 virus whilst at the same time supressing effective early treatment protocols based on re-purposed drugs¹² is used to illustrate the shortcomings of this largely privatised existing institutional framework to realise the HRS. The focus is on the dysfunction of the institutional framework to enable the implementation of states’ duties to anticipate the (risks of) harm and (opportunities for) benefits of (medical) science, as well as the implementation of international organisations’ anticipation responsibilities for the HRS. This is used as a basis for sketching some of the potential features that a reformed institutional framework, including a reformed World Health Organization (WHO), should probably have, grounded in the HRS. Among them are features that ensure the public nature of the institutional framework allowing for democratic control over the entire scientific enterprise, including, where necessary through extensive cooperation and coordination of the (domestic) specification of state anticipation duties and their allocation and implementation through international institutions that ‘work along egalitarian lines’.¹³

The analysis proceeds in four steps. Section 2 summarises scientific developments around the appearance of SARS-CoV-2 in late 2019, resulting in the development and global promotion and distribution of investigational Covid-19 vaccines through the existing institutional framework comprising domestic, European (European Medicines Agency (EMA)) and global (WHO) medical (quasi-¹⁴)regulators and the Covax¹⁵ distribution network, a public-private partnership (PPP) run jointly¹⁶ by the WHO, the Vaccine Alliance Gavi and the Coalition for Epidemic Preparedness Innovation (Cepi).¹⁷ It also highlights the deficits of this partly privatised institutional framework to secure everyone’s HRS. Taking a step back to set the scene for an analysis of the desirable features of a reformed institutional framework, section 3 summarises the understanding of science as a communal and participatory endeavour that underlies the three-pronged scope of the HRS. Section 4 elaborates on states’ corresponding duties and international organisations’ responsibilities flowing from the HRS to anticipate both the benefits and harm of science, and to promote the former and protect against the latter with due care. Section 5 examines (some of) the features that a (reformed) institutional framework should possibly have to enable state duty-bearers and international organisations as responsibility-bearers to effectively discharge these anticipation duties and responsibilities. This is done inter alia by relating the analysis back to the example of the institutional shortcomings introduced in section 2. Section 6 concludes.

2. The current dysfunctional institutional framework to anticipate the harm and benefits of science: the example of scientific responses to the appearance of SARS-CoV-2

In January 2020, the WHO classified the appearance of SARS-CoV-2 as a Public Health Emergency of International Concern (PHEIC) under the International Health Regulations (IHR).¹⁸ Despite the low average infection fatality rate (IFR) of the illness Covid-19 caused by SARS-CoV-2 that was clear early on,¹⁹ the WHO upheld the Covid-19-PHEIC for more than three years until the 5th of May 2023.²⁰ The existence of the Covid-19-PHEIC justified the recommendation of far-reaching emergency medical and non-medical countermeasures,²¹ and in particular the rapid development, global distribution and mass administration of investigational vaccines. Many of the WHO’s recommendations were contrasting long-accumulated public health wisdom on pandemic response found inter alia in WHO documents,²² as they were now expressed in the language of and dominated by the approach of the Global Health Security (GHS) doctrine.²³ And indeed, there is mounting evidence that SARS-CoV-2 is a laboratory-generated virus,²⁴ and even the result of potentially illegal²⁵ bioweapons research.²⁶

Novel mRNA- or DNA-based vaccines²⁷ against Covid-19 have been hailed as a ‘remarkable initiative and breakthrough’²⁸ in science, as ‘phenomenal’ and ‘potentially game-changing’²⁹ and as ‘one of the greatest achievements of mankind’,³⁰ capable of ridding the world of the respiratory SARS-CoV-2 virus in a PHEIC. They have been developed in record speed,³¹ funded by governments around the world, based on several new technologies never approved for the use in vaccines before.³² Despite the limited data available from phase I and II clinical trials (with data from phase III clinical trials now never to be completed³³), and no safety and efficacy data from controlled long-term human and post-marketing pharmacovigilance studies, both the EMA and the WHO granted various investigational mRNA-based vaccines conditional marketing authorisation,³⁴ or an emergency use listing (EUL)³⁵ respectively already in late 2020 and early 2021. Whilst full authorisation by EMA followed in October 2022 for the BioNTech/Pfizer and Moderna vaccines,³⁶ WHO currently has 15 investigational vaccines against Covid-19 on its emergency use list.³⁷ None of WHO’s EUL vaccines are fully licensed medical products,³⁸ and are therefore referred to in technical WHO documents as ‘investigational’ (i.e. experimental).³⁹ Their use is justified by the WHO during PHEICs declared by the WHO Director-General on the assumption that ‘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.’⁴⁰

Once the vaccines obtained an WHO EUL, they were (and still are) promoted, distributed and administered worldwide by WHO and its public-private partners, especially through Gavi and Covax.⁴¹ Their administration has also been promoted through mass vaccination campaigns by WHO member states and the EU. The WHO’s Covid-19 Emergency Committee has issued regular benchmarks for the percentage of each country’s population that is to be vaccinated by a particular date,⁴² and has, in concert with member states and corporate and religious actors, recommended and implemented various measures to encourage, nudge and coerce as many people as possible into taking the investigational products,⁴³ justified by the assumption that this is necessary and proportionate in order to address the Covid-19-PHEIC. Alternative effective early treatment protocols relying primarily on re-purposed drugs developed at local level all around the world,⁴⁴ including by community doctors, have not only not been promoted by the WHO,⁴⁵ but arguably actively suppressed.⁴⁶

Moreover, via its so-called ‘infodemic management’ programme,⁴⁷ the WHO in cooperation with its member states, the UN, EU, big technology companies, major news agencies and media corporations have ‘pre-bunked’, ‘de-bunked’ and censored numerous contributions questioning among other things the official line of ‘safe and effective’ vaccines, the strategy to vaccinate the entire world’s population with an investigational gene-based product, the viability of the clinical trials conducted in particular by BioNTech/Pfizer and Moderna, any discussion about early treatment protocols that have proven effective, as well as the solidifying evidence of SARS-CoV-2 as an engineered virus originating from GoF-research.⁴⁸ The WHO announces on its website that it, together with Youtube, has deleted 850,000 videos between February 2020 and January 2021 alone containing ‘medical mis- or disinformation’ criticising or questioning ‘correct’ medical or scientific information as defined by the WHO and the experts constituting many of the WHO’s advisory committees.⁴⁹

Emerging evidence, however, gives rise to serious and well-founded doubts about the effectiveness and safety of the investigational vaccines, suggesting that the new mRNA/DNA technology on which they are based carry a high degree of risk of severe harm for individuals. Concerning effectiveness, even WHO recognised now that the vaccines do not block transmission;⁵⁰ that the manufacturers’ claims on 95% effectiveness of the vaccines in late 2020 always referred to relative effectiveness as opposed to absolute effectiveness with the latter being on average about 1% for the EUL vaccines available so far;⁵¹ and that clinical trials conducted by manufacturers show serious deficits.⁵² Concerning safety, early warning systems recording reports on short-term adverse drug reactions show a worryingly high number of reports on the investigational Covid-19 vaccines. As of July 2023, 35,596 deaths have been reported to the US Vaccine Adverse Event Reporting System (VAERS);⁵³ 28,299 deaths to EMA’s EudraVigilance database;⁵⁴ and 28,854 deaths in the WHO’s own Global Individual Case Safety Reports database, VigiAccess.⁵⁵ These numbers by far exceed the number of reports on deaths occurring after the administration of conventional vaccines.⁵⁶ The number of reports on diverse non-fatal adverse effects is also very high in all three databases,⁵⁷ confirmed by a recent re-evaluation of BioNTech/Pfizer’s and Moderna’s original trial data.⁵⁸ These include serious adverse effects such as myocarditis/pericarditis, thrombocytopenia, anaphylactic shocks, autoimmune disorders and nervous system disorders.⁵⁹

To summarise: the example of the release of the in all likelihood engineered SARS-CoV-2 virus, the continued global administration of investigational Covid-19 vaccines despite the safety signals summarised above, as well as the suppression of effective early treatment protocols illustrate the dysfunction of the current institutional framework set up to implement anticipation duties under the HRS in both the health and (bio-)security context. Even if one accepts that Covid-19 indeed amounted to a PHEIC lasting more than three years despite the low IFR and highly age-stratified disease pattern, this has allegedly led to violations of the HRS (potentially amounting to undue negligence), and with it also to violations of other human rights including the rights to health, life, privacy, freedom of expression and to receive and impart information and freedom of movement. If plans will materialise to build up institutional capacities for comprehensive global biomedical surveillance, to conduct renewed rapid global vaccination campaigns with investigational products⁶⁰ and making freedom of movement within states and across borders conditional upon the possession of digital health passports⁶¹ to allegedly ensure GHS, these violations are likely to be repeated.⁶² Moreover, if dangerous GoF-research, conducted likely in violation of the 1972 UN Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (BWC), is not thoroughly investigated and terminated globally, and this termination supervised through a publicly funded international institution, the possibility is high of new pandemics occurring, either through the intentional or unintentional release of engineered viruses or other modified biological agents.

An attempt is therefore made to arrive at a better understanding of how anticipation duties under the HRS should be effectively implemented through reformed public domestic and international institutions. As a first step, the notion of ‘science’ as a communal endeavour or practice underlying the HRS as well as the three-pronged scope of the HRS are examined.

3. The three-pronged scope of the HRS and science as a communal (public) good

The CESCR,⁶³ scholars⁶⁴ and international documents⁶⁵ interpreting the HRS protected by Art.15(1)(b) ICESCR and Art.27 UDHR point to three components of this right: first, the right to freely participate in scientific processes and their organisation; second, the right to share and access, and to enjoy the benefits of scientific progress and its applications;⁶⁶ and third the right to be protected against the harm of science and its applications. Paragraphs (3) and (4) of Art.15 ICESCR recognise additional crucial elements of the HRS: freedom of science⁶⁷ and the need to nurture ‘international contacts and co-operation in the scientific [ …]  field’.⁶⁸

What is core to this understanding of the HRS’ scope is the communal element of science and scientific processes in which ‘everyone’ has the equal individual right to participate⁶⁹ and thereby to collectively shape, organise and limit it, and to both share in the benefits and applications of science and scientific processes and, at the same time, be protected against the harm thereof.⁷⁰ In parallel, scientific freedom shall be upheld, benefitting everyone engaging directly with science and in scientific processes, including professional scientists and citizen scientists.⁷¹ This is not a contradiction, but points to the fact that this freedom is essential to enable science as a participative and communal, but open-ended sceptical process of (objective) studying and knowledge seeking in the first place,⁷² encompassing both natural sciences and social sciences and humanities.⁷³ It thrives on transparency, openness, constant questioning, reasoning, critical inquiry and evidence-based challenging of established ‘truths’.⁷⁴ As confirmed by Art.15(1)(b) ICESCR and Art.27 UDHR, neither of which establishes that science should serve a particular purpose,⁷⁵ science and scientific processes and practice are in the first place disinterested and open-ended, that is, results-open. Drafters of both instruments rejected proposals to include a passage that science should serve a particular purpose⁷⁶ as they felt that this would open the doors for instrumentalisation, e.g. placing science at the service of ideologies, politics or technocratic social engineering projects, giving states undue levels of control over scientific research and creative activity.⁷⁷ As highlighted by Beiter, this fits well with the fact that open-ended and unbiased scientific inquiry is by definition ‘unmanageable’, precisely because it is open to all sorts of (objective) results in its quest to generate original knowledge.⁷⁸

Respecting and nurturing scientific freedom, scientific inquiry and result-open science will moreover enable sincere, unbiased scientific explorations through which a maximum of knowledge⁷⁹ is discovered, which, in turn, will enable enjoyment of the two other components of the HRS – the right to enjoy the benefits of science and the right to be protected from its harm. Maximum knowledge generation through communal participative scientific processes respecting scientific freedom may a) yield scientific practice, ‘progress’, applications and technologies that can indeed constitute a benefit to societies; and b) they may at the same time yield knowledge of and openness about (risks of) harm of science, scientific processes and their results.

This further indicates that science and participative scientific processes protected by the HRS should not be instrumentalised for purely economic purposes, and that these processes or parts thereof, or their results and applications should not be privatised for commercial purposes, or otherwise withdrawn from equal accessibility and democratic control.⁸⁰ This is in line with Lea Shaver’s apt observation that under the HRS, science – the process, its results and applications – should be understood and governed ‘as a global public good, rather than as private property’.⁸¹ This re-emphasises the understanding of science as a communal enterprise.

This does not imply, of course, that the HRS prohibits employing scientific processes purely for private commercial purposes. Whilst there is no human right to participate in such scientific processes solely for private commercial gains as this type of science/scientific research cannot be categorised as open-ended, results-open and communal, both the right to share in the benefits and applications⁸² and the right to be protected from adverse effects extends to benefits and applications as well as harm from science and scientific processes conducted for either private commercial or military/security-related or any other purpose.

The notion of open-ended science, scientific freedom and science as a communal endeavour underlying the HRS does also not suggest that the scientific processes protected by the HRS cannot be shaped, directed and limited at all in ‘democratic societies’ or that freedom of scientific research is absolute.⁸³ Rather, the three components of the HRS point to the fact that it can be determined collectively – through democratic processes based on political equality – which scientific enquiries should be prioritised and publicly funded within a specific society (and even globally through cooperation and coordination), as long as results of these open scientific processes are not pre-determined (e.g. by excluding the possibility of unexpected or serendipitous results or failure);⁸⁴ and in particular, which ‘applications’ (e.g. goods, services, processes, techniques, technologies, etc.) resulting from such scientific inquiries are sufficiently ‘progressive’ to constitute a true ‘benefit’ to be enjoyed by and distributed to ‘everyone’.⁸⁵ Moreover, understanding science as a participatory and communal endeavour and practice indicates that also decisions about what severity of potential harm and degree of risk of science and technology are acceptable,⁸⁶ how they are to be prevented and monitored, and how they are to be balanced against the potential benefits arising from science and technology in a particular context, should be taken through democratic processes.⁸⁷ Thus, democratic processes can shape, direct and limit scientific inquiries in light of collective preferences, cultures and local (or even global) challenges and threats, and allocate public resources accordingly.⁸⁸ This is affirmed by IHRL’s grounding in the mutuality of equality, human rights and democracy,⁸⁹ which is clear from equality and non-discrimination provisions⁹⁰ as well as political participation rights⁹¹ and numerous references to ‘democratic societies’.⁹² It also seems to be in this sense that the CESCR in General Comment 25 suggests that science ought to serve human rights and peace (presumably by promoting its benefits and protecting against harm) as a priority over all other uses;⁹³ but at the same time places great emphasis on the need to secure freedom of science and cherish disinterested, open-ended scientific inquiries.⁹⁴

4. Anticipation duties and responsibilities flowing from the HRS

This brings the discussion neatly to the question about the content and scope of states’ anticipation duties flowing from the HRS (4.1); and the content and scope of anticipation responsibilities for the HRS addressing international organisations and other non-state entities, as well as third states that do not exercise jurisdiction (4.2).⁹⁵

4.1. Dual duties to anticipate diligently the (risk of) harm and (opportunities for) benefits of science

Among the important duties addressing states as duty-bearers⁹⁶ under the HRS are the dual duties to anticipate both the (risks of) harm and, at the same time, the (opportunities for) benefits of science, scientific processes and resulting applications.⁹⁷ More concretely, these are duties to identify and protect against (risk of) harm on the one hand, and duties to identify and promote (opportunities for) benefits of science on the other hand,⁹⁸ with due diligence as the required standard of conduct.⁹⁹ Other duties flowing from the HRS will ensure that states have the capacities to anticipate both (risks of) harm and (opportunities for) benefits of science and to consequently diligently prevent, avoid or mitigate the former and promote the latter. Among these other duties are duties to respect, protect and fulfil scientific freedom and to receive and impart scientific information, to ensure informed consent, and the overarching duty to ensure democratic (public) control over the scientific enterprise, including the specification of anticipation duties in context.

• a) Duties to identify and protect against (risks of) harm of science and its applications

The first part of the dual anticipation duty flowing from the HRS is the duty to identify and to protect¹⁰⁰ diligently against (risks of) harm of science and/or emerging technologies and scientific innovations. As in other areas of international human rights law, such (mostly positive) duties under the HRS arise in particular when the risks of harm have reached a minimal threshold,¹⁰¹ i.e. when they are risks of ‘real’ and ‘immediate’ harm,¹⁰² implying also that they are foreseeable,¹⁰³ that is, state duty-bearer knew or should to have known¹⁰⁴ about them.¹⁰⁵ Risks of real and immediate harm from science or its applications that require due diligence conduct¹⁰⁶ from duty-bearers can vary widely and can arise for instance at the level of the individual, at the level of domestic communities or global society and even at the level of the humanity itself¹⁰⁷ (in particular risks of real and immediate harm that may primarily result in violations of the (participatory and communal) core content of the HRS but also, at the same time, the core content of other human rights).

The more specific measures duty-bearers shall diligently take to protect against such risks of real and immediate harm are highly context-dependent, but involving necessity and proportionality analyses.¹⁰⁸ If, for instance, the severity of real and immediate harm and/or the degree of risk of such harm are very high,¹⁰⁹ strict legislative, monitoring, information and enforcement measures may be required right up to prohibitions to carry out certain research and/or to share and distribute certain research results or technologies. This is the case for example in the area of chemical and bioweapons research,¹¹⁰ concerning the ban on (heritable) human genome editing,¹¹¹ and concerning the prohibition to coerce individuals into taking part in medical or scientific experiments.¹¹² If the real and immediate harm is less severe and/or the degree of risk thereof is lower, mitigation or avoidance duties to diligently enact legislation, to conduct impact assessments,¹¹³ to monitor, to provide information to the public,¹¹⁴ to conduct ethics reviews,¹¹⁵ take required budgetary measures,¹¹⁶ etc. still arise, but they may be less stringent. An example would be the area of medical research with an entire body of medical law regulating inter alia the conduct of medical trials and the manufacturing of medical products to ensure that only medical products and innovations are distributed that are safe (and effective) in addressing one or more precise conditions, and where adverse effects (or risks thereof) have been sufficiently well delineated to conclude that they are tolerable and manageable in individual cases.¹¹⁷

The more concrete scope of anticipation duties (and their stringency) to diligently address real and immediate harm from science may also be influenced by further considerations, such as the extent to which states have the capacity to address that harm. It might be, for instance, that the sources of harm of science and its applications are located outside the respective state’s territory of jurisdiction or that they are exclusively under the control of influential private entities. In such cases, duties to cooperate and to coordinate internationally (including the co-specification of prevention and precaution duties among states¹¹⁸) may become particularly important.¹¹⁹ And, as discussed further in section 4.1.e) below, under the HRS it should not only be determined scientifically, i.e. based on the current state of scientific knowledge or what is deemed to be a ‘scientific consensus’, what the risks of real and immediate harm from science are that should be diligently prevented or mitigated, but other considerations may play a role in the normative reasoning of a self-determined ‘democratic society’ about such questions.¹²⁰

Whilst many anticipatory duties to protect against real and immediate harm are positive duties to with due diligence ‘protect’ against harm emanating from scientific activities and their applications of third parties and positive duties to ‘fulfil’, negative duties to ‘respect’ can also arise. Among them are for example duties not to allocate public funding to scientific research that risks causing real and immediate harm, not to manipulate or suppress reports and data on harmful effects of science and its applications,¹²¹ not to undermine effective international cooperation for the control of risks of real and immediate harm from science and its applications,¹²² and duties to refrain from using harmful technologies and/or making them available to third parties. An example here might be duties to refrain from using certain networked digital surveillance technologies which may undermine science as a communal, participative process as protected by the HRS and, in addition, may ‘in manifold ways […] threaten human rights and the rule of law [more broadly] and may erode vibrant, pluralistic democracies’.¹²³ The Office of the UN High Commissioner on Human Rights (OHCHR) has described this threat as ‘profoundly alarming’.¹²⁴ Moreover, duties to remedy arise.¹²⁵

• b) Duties to identify and promote (opportunities for) benefits of science

The second part of the dual anticipation duty flowing from the HRS is the duty to identify and promote¹²⁶ the benefits and opportunities for benefits of science and its applications. Though not expressed in such terms by the CESCR in its General Comment 25, in parallel to the risks of harm discussed above, the opportunities for benefits of science, scientific knowledge and its applications that states as duty-bearers shall promote shall arguably be opportunities for real and immediate benefits,¹²⁷ i.e. they shall indeed constitute ‘progress of science and its application’, where science is understood as the communal and participatory endeavour described in section 3. In addition, (opportunities for) benefits must arguably be foreseeable, i.e. states knew or should have known about them for duties to diligently promote them to arise.

More concretely, and in accordance with Art.15(2) ICESCR, states shall develop, conserve and diffuse (potentially) beneficial scientific knowledge and ensure broad access to and availability of (potentially) beneficial applications of science and technologies.¹²⁸ The exact scope and content of the diligent legislative, administrative, (public) budgetary and other measures to be taken towards the promotion of the opportunities for real and immediate benefits of science and its applications will once more depend on context,¹²⁹ inter alia on the size of the (opportunities for) benefit,¹³⁰ the degree of certainty with which it may materialise and the capacities of the respective state, including its financial means¹³¹ and its ability to overcome existing obstacles to ensuring access, availability and diffusion.¹³² Once more, these obstacles or threats may be located outside the jurisdiction of the duty-bearing state, or be due to the control private entities have over the benefits of science and its application in question. Of course, also in regard to the promotion of benefits of science and its applications both positive duties to ‘protect’ and to ‘fulfil’ arise, including remedial duties,¹³³ as well as negative duties to ‘respect’.

• c) Duties to respect, protect and fulfil scientific freedom and to receive and impart scientific information

Though not immediately obvious, upholding scientific freedom and the conduct of results-open, participatory scientific processes are important duties that will allow states to also implement their anticipation duties discussed above. Protecting scientific freedom would include a duty not to interfere with, and pro-actively protect and fulfil, the choices and priorities set by scientists themselves,¹³⁴ as well as their freedom to collaborate with one another (including across borders)¹³⁵ and their freedom of expression and the freedom to seek, receive and impart scientific information,¹³⁶ including through publishing the results of their research;¹³⁷ and to ensure that all persons and public and private entities do so.¹³⁸ This would also entail a duty to secure the institutional autonomy and self-governance of universities¹³⁹ and other public research institutes, as well as their financial independence.¹⁴⁰ The latter requires states to ensure that public funding or funding provided by private entities for collective scientific research processes protected by the HRS is unconditional in the sense that it respects the openness and freedom of science and the unpredictability of its outcomes. Thus, such funding not unduly restrict or determine the (commercially, militarily, ideologically or otherwise desired) outcome of the research activities undertaken by professional or citizen scientists, and the evaluation of the risks and harm connected with specific scientific research and its outcomes as well as its potential benefits.¹⁴¹ Complying with these duties will ensure rigour as well as transparency and openness of scientific processes which, in and of itself, will contribute to revealing, understanding and monitoring risks of harm and opportunities for benefits of science, technology and/or the products and applications they yield.¹⁴² This in turn will make these risks and benefits ‘foreseeable’ for states, enabling them protect against harm and promote benefits.

• d) Duties to ensure free and informed consent

The stringent¹⁴³ duty on states to ensure that all persons and public or private entities that conduct scientific or medical research involving human participants obtain free, prior and informed consent,¹⁴⁴ and that participants are aware of their right not to participate in medical or scientific experiments¹⁴⁵ and their right to withdraw their consent at any time¹⁴⁶ is another state duty flowing inter alia from the HRS. This duty is reinforced by Article 7 ICCPR, the prohibition of torture or inhuman or degrading treatment, which directly establishes that ‘no one shall be subjected without his free consent to medical or scientific experimentation’.¹⁴⁷

Obtaining free, prior and informed consent explicitly requires that scientists and medical researchers continuously inform participants of scientific or medical experiments in an understandable way about all known and unknown evolving short-term and long-term harm and risk thereof that participation implicates.¹⁴⁸ At least for research involving human participants, this will require that scientists thoroughly evaluate and monitor the harm and risks associated with their research and the applications it produces, and that they communicate them openly. Moreover, ensuring free and informed consent means that neither direct coercion, nor indirect coercion, nor any other form of undue pressure or incentives can be relied on to coerce, pressurise or entice individuals’ participation in medical or scientific experiments or clinical trials.¹⁴⁹ This will also further transparency and openness on known and unknown harms and risks involved, and help to prevent instrumentalisation of scientific research.

For scientific research not involving human participants other independent mechanisms, from ethical approval processes to continuous monitoring and reporting,¹⁵⁰ can ensure that scientists and researchers are required to constantly observe, record and communicate the short- and long-term harmful effects (or risks thereof) that their research and outputs may have on science as a communal and participative enterprise, as well as humans, animals and the natural world.

• e) Duties to ensure democratic participation in the assessment of (risks of) harm and (opportunities for) benefits of science

One aspect of the overarching duty under the HRS to ensure the democratic control over the communal scientific enterprise as a whole¹⁵¹ is the duty to specify in context, through a democratic process, the thresholds of risks of harm of science and its applications that a particular ‘democratic society’ may tolerate, as well as the priorities for the promotion of (potentially) beneficial scientific research and knowledge and applications of science. It is clear that the materialisation of risks of real and immediate harm emanating from science and its applications that interfere with the inherent minimum core content of the HRS or other human rights shall be diligently prevented, avoided or mitigated as part of states’ anticipation duties under the HRS. The assessment and evaluation of other harms and risks thereof can, however, vary in accordance with cultural, ethical, religious, social, financial and other factors and preferences, in particular when uncertainties are involved, or the matter is a matter of pervasive reasonable disagreement within a democratic society. The same is true for the assessment and evaluation of (opportunities for) benefits of science and its application. Moreover, there can be cases in which a fair balance must be struck between duties to prevent risks of harm on the one hand and duties to promote benefits on the other hand, in particular when the risks and benefits emanate from so-called dual-use scientific research, scientific innovations or technologies. The numerous references to ‘participation’/'participatory processes’¹⁵² and even ‘democracy’/‘democratic debate’/‘democratic society’¹⁵³ in the CESCR’s General Comment 25 indicate, that in such cases, states are duty-bound to ensure that decisions are taken via an open, informed, democratic debate, respecting everyone’s equal HRS, resulting in the adoption of relevant domestic laws capturing the contextualised results. Participation and democratic processes will furthermore address secrecy and collusion that threaten the integrity of science and thus promote transparency,¹⁵⁴ including in regard to its benefits and harm. The CESCR observes in this context:

‘ … in controversial cases, participation and transparency become crucial because the risks and potential of some technical advances or some scientific research should be made public in order to enable society, through informed, transparent and participatory public deliberation, to decide whether or not the risks are acceptable.’¹⁵⁵

• f) Duties to cooperate and coordinate internationally

Duties to cooperate flow from the HRS, supported also by Arts.2(1) and 15(4) ICESCR. Such cooperation and coordination is necessary in particular when harms (or risks thereof) emanating from science and technology are cross-border harms or risks, and diligently protecting individuals from them requires cooperation and coordination with other states,¹⁵⁶ and even the domestic co-specification of anticipation duties among states and their coordinated implementation.¹⁵⁷ The latter is the case for example when a specific (real and immediate) risk of harm of science – e.g. the conduct of GoF research – can only be prevented when all states together secure the prohibition of such research as the expression to prevent the specific, and in this case global, harm of GoF-research and science. This requires that states co-specify their domestic prevention duties. Similar cooperation and coordination duties arise in relation to the promotion of (opportunities for) benefits of science and its application, access to which can often indeed only be secured through international cooperation and coordination.

Cross-border scientific engagement and debates will also enable researchers and scientists to openly share their concerns on harms and risks of harm of certain scientific and technological research, developments, innovations and their applications, as well as their expectations of potential benefits. This, in turn, can enable low-income states with limited capacities and resources to react to such concerns even if their scientists may lack access to relevant information, certain expertise and/or resources, and adopt measures to enable the enjoyment of benefits.¹⁵⁸

International cooperation and coordination duties among states will also arise in relation to third entities like multinational corporations whose primary concern is to maximise profits for their shareholders from the scientific research they employ towards this end, and not to secure science as a (communal) public good whose benefits are promoted and shared and whose risks of harm are prevented and controlled for everyone equally.¹⁵⁹ States’ cooperation and coordination duties to ‘protect’ should thus ensure that the scientific activities of multinational corporations do not cause harm, and that benefits are made widely accessible. For example, this would imply that states shall cooperate and coordinate in order to ensure that legal protection of informed consent of participants in medical or scientific research is upheld and enforced together in all countries to prevent pharmaceutical companies from carrying out clinical trials in low-income countries due to lower costs and low levels of domestic legal protection of informed consent, to the detriment of the communal and participatory scientific enterprise as a whole and of the people living in low-income countries, undermining these people’s HRS.¹⁶⁰

Last but not least, states must uphold their duties under the HRS as members of international organisations, and make sure that decisions taken, and policies adopted by these organisations do not undermine their ability to secure the HRS within their territory, including their anticipation duties. If competences are transferred to international organisations, states must ensure that human rights protection provided by the organisation is equivalent to that required of the states’ duties.¹⁶¹

4.2. Responsibilities to anticipate diligently (risks of) harm and (opportunities for) benefits of science

Entities other than states of jurisdiction have anticipation responsibilities¹⁶² for the HRS. Their overarching aim, which, in turn, determines their scope, is not to undermine but to enable and assist states of jurisdiction to discharge their anticipation duties under the HRS that these states owe to the people under their jurisdiction.¹⁶³ Their scope is thus regularly determined in relation to states’ jurisdiction-based anticipation duties.¹⁶⁴ Though not elaborated on directly in General Comment 25,¹⁶⁵ many other General Comments of the CESCR identify international organisations like the WHO¹⁶⁶ and other UN organisations and specialised agencies¹⁶⁷ and the EU,¹⁶⁸ but also private actors like business enterprises,¹⁶⁹ NGOs,¹⁷⁰ research institutions,¹⁷¹ among the bearers of responsibilities for human rights. Moreover, states that do not exercise jurisdiction have responsibilities for human rights in all other states.

Responsibilities are not owed to concrete individuals but to states and their (democratic) institutions. The CESCR has for example highlighted that international organisations should cooperate effectively ‘in relation to the implementation of [human …] right[s …] at the domestic level’,¹⁷² i.e. in supporting states in their efforts to discharge their human rights obligations. The same can be inferred from statements concerning responsibilities of other non-state entities owed to states,¹⁷³ as highlighted in particular in the 1999 UN ‘Declaration on the Right and Responsibility of Individuals, Groups and Organs of Society to Promote and Protect Universally Recognized Human Rights and Fundamental Freedoms’.¹⁷⁴ This Declaration points to non-state entities’ ‘responsibility in … promoting human rights … and contributing to the promotion and advancement of democratic societies, institutions and processes’,¹⁷⁵ where the latter are required for states to be able to implement their human rights obligations – including their anticipation duties under the HRS – in the first place.

Since responsibilities for human rights do not depend on the exercise of (human rights) jurisdiction, grounds for allocating them to specific bearers must be identified. Among them are capacity (which can include expertise, knowledge and power¹⁷⁶), outcome, causality, harm, benefit or special ties.¹⁷⁷ When it comes to anticipation responsibilities under the HRS, international organisations engaged in science, epistemic communities actively involved in scientific processes (including those institutionalised in universities or other research organisations) and corporations relying on scientific research are among the prominent responsibility-bearers.

The CESCR remains largely silent about the legal basis for responsibilities for human rights in general and for anticipation responsibilities for the HRS in particular. Art.2(1) ICESCR can be identified as the legal basis for responsibilities for human rights of states that do not exercise jurisdiction,¹⁷⁸ and Art.15(4) ICESCR for their anticipation responsibilities for the HRS. For international organisations, such responsibilities can derive from their constitutive instruments or international agreements to which they are parties as well as customary IHRL.¹⁷⁹ When it comes to the WHO, for instance, both the references to human rights and in particular the right to health in its Constitution¹⁸⁰ and references to human rights in the IHR¹⁸¹ can be seen as legal bases for responsibilities for the human right to health and the HRS, as can emerging customary IHRL addressing international organisations.¹⁸² The latter may also address other non-state responsibility-bearers,¹⁸³ though open questions remain as to what counts as state practice and opinio iuris in this context which cannot be examined here further. In addition, (mostly non-binding) declarations exist which specify responsibilities for different human rights addressing various state¹⁸⁴ and non-state¹⁸⁵ actors in different contexts. The legal weight/degree of normativity of various responsibilities for human rights, including anticipatory responsibilities for the HRS, can vary, depending also on the extent to which they have been concretised and are thus sufficiently precise and foreseeable for respective responsibility-bearers. There is, however, no tailored institutional framework as of yet through which anticipatory responsibilities for the HRS might be specified and allocated to the various responsibility-bearers, especially no international institutional framework.¹⁸⁶

5. Sketching the public institutional framework

The discussion now moves to the institutional questions: What domestic and international institutions¹⁸⁷ are states parties to the ICESCR obliged to set up so that they can identify, specify and discharge their anticipation duties under the HRS? The example of the in all likelihood engineered SARS-CoV-2 virus and the global response to develop, distribute and administer investigational vaccines based on a new technology to the world’s population to stop its spread, as well as the parallel suppression of effective early treatment protocols is returned to with the aim to highlight the features that this institutional framework should possibly have with the help of this concrete example.

5.1. The domestic public institutional framework

In general, human rights treaties envisage domestic democratic or democratising public institutions for the implementation of states’ human rights duties, including the anticipatory duties flowing from the HRS. For example, the CESCR has confirmed that the ICESCR ‘neither requires nor precludes any particular form of government or economic system being used as the vehicle for the steps [to be taken to implement socio-economic rights] … , provided only that it is democratic,’¹⁸⁸ whilst the ECtHR has long held that ‘democracy is the only political model contemplated by the [European] Convention [on Human Rights] and, accordingly, the only one compatible with it.’¹⁸⁹ They have further specified that this implies the existence of a comprehensive unitary institutional framework consisting of an elected legislature¹⁹⁰ and an independent judiciary,¹⁹¹ and that democratic institutional systems are further incorporating various principles, such as the separation of powers,¹⁹² free elections,¹⁹³ political pluralism¹⁹⁴ and judicial review.¹⁹⁵ This also points to the fact that institutions securing human rights shall be public institutions that allow for the identification and specification of human rights duties within the domestic context through democratic contestation and judicial review, respecting political equality and the inherent cores of the human rights of all members of ‘democratic societies’, and securing and controlling funding for the implementation and enforcement of these duties.¹⁹⁶ Private entities should be separated from and controlled by public institutions exercising democratically-controlled public authority. Through internal allocation in domestic (criminal or private) law adopted by public democratic institutions, private entities can have derived obligations to contribute to the implementation of the HRS and other human rights (e.g. by paying taxes or providing access to scientific knowledge) and to refrain from interfering with their enjoyment. In addition, states may need to set up specialised public institutions – for example an ethics council,¹⁹⁷ research funding institutions,¹⁹⁸ universities,¹⁹⁹ a medical agency, etc. – to implement the HRS in particular.

• a) Domestic legislative institutions

Legislative domestic institutions shall adopt relevant domestic law conforming to the human rights legality²⁰⁰ standard in terms of quality and democratic origin in order to specify, internally allocate and implement the various anticipation duties under the HRS discussed above. In relation to the appearance of SARS-CoV-2 and subsequent laws and policies involving the development and promotion of some scientific research and new technologies whilst supressing others several questions would arise. In particular: whether domestic legislatures of states that ratified the ICESCR have, through a thoroughgoing, transparent and open deliberative debate²⁰¹ assessed both the risks of real and immediate harm and opportunities for real and immediate benefits of GoF-research with SARS-CoV viruses, the strong promotion of research, development and large scale administration of investigational vaccines based on novel mRNA/DNA technologies and the suppression of early treatment protocols for Covid-19 developed by community doctors around the world, and adopted relevant legislation to promote real and immediate benefits and prevent real and immediate harm.

Concerning GoF research with SARS-CoV, a strict legal prohibition would be in line with a good faith interpretation of Art.1 of the 1972 BWC.²⁰² Given the harm that was caused by the likely release of the engineered SARS-CoV-2 virus from a research laboratory, it is clear that this harm is real and immediate; and that the harm from another laboratory-generated virus resulting from GoF-research can be immense and the risk of such harm occurring high, justifying a strict prohibition of GoF-research with viruses in domestic law. Moreover, given the global harm from GoF-research, collective duties on states arise to globally coordinate and co-specify such a prohibition and its implementation and enforcement.²⁰³ Coordination could happen inter alia by strengthening and possibly reforming international institutions like the Implementation Support Unit for the BWC, operating within the UN Office for Disarmament Affairs;²⁰⁴ and ensuring that coordination and co-specification encompasses states’ anticipation duties to protect, i.e. duties that make sure that military and security actors, including private military and security companies, do not engage in risky and harmful GoF-research.

Concerning the legal and political suppression of early treatment protocols with repurposed drugs in many countries, even though these repurposed drugs appear safe and effective against the Covid-19 illness²⁰⁵ and thus involve very limited and well delineated adverse effects that are manageable in individual cases,²⁰⁶ questions arise as to why they allegedly have nonetheless been assessed as too risky, and why benefits have not been recognised and promoted by domestic law and policy. The latter included in many countries the suppression of the sharing of relevant scientific and medical knowledge generated by doctors working at local level all around the world.

Concerning the promotion of investigational vaccines, in line with the CESCR’s proposal on how to proceed in ‘controversial cases’ characterised by high degrees of uncertainty and disagreement, though unlikely, it is not a priori excluded that despite the low average IFR of Covid-19 and the fact that effective and safe early treatment through repurposed drugs is available, legislation is adopted enabling first of all public investment into the development of vaccines based on novel mRNA/DNA technology. And second, legislation permitting the subsequent distribution and administration of investigational vaccines might be embraced. Such decisions would reflect the possible willingness of a (democratic) majority to accept both the associated potential severe harm and a high degree of risks of such harm associated with the mass administration of such investigational medicinal products in a situation of an alleged health emergency. However, decisions must indeed be taken a) as a result of an ‘informed, transparent and participatory public deliberation’²⁰⁷ involving and taking account of both everyone’s equal HRS and other human rights. Moreover, if b) the risks of real and immediate harm are recognised the due diligence standard of conduct would require that further safeguards are legislated for to monitor the risks of real and immediate harm, inform about, and clearly limit and, as far as possible, prevent them.²⁰⁸ Existing legislation already safeguarding against (risks of) harm of newly developed medicinal products would need to be very carefully applied to the distribution and administration of the investigational Covid-19 vaccines, in particular when clinical trials have not been finished due to an alleged health emergency.

In regard to a) the democratic decision-making process would require full transparency and a thorough examination and discussion of all available data, information and knowledge, including those held by universities, domestic medical agencies or public health institutes, private actors like pharmaceutical companies,²⁰⁹ PPPs and international organisations like the WHO and the EU, and in particular their relevant specialised technical committees. Among them are for example the WHO’s technical Advisory Committee for Emergency Use Listing (TAG-EUL) making the decisions to grant EULs,²¹⁰ and EMA’s Committee for Medicinal Products for Human Use (CHMP) making scientific recommendations to grant conditional and full marketing authorisations.²¹¹ Similarly, recommendations coming from these organisations or specialised domestic institutions, e.g. WHO recommendations to vaccinate a certain percentage of the population by a specific date,²¹² should be discussed, legislated for and implemented in light of local preferences concerning the severity of harm and degree of risk of such harm occurring that a specific ‘democratic society’ is willing to accept; and recommendations violating IHRL, in particular the inherent core of the HRS or of other human rights, should not be implemented. Among such recommendations would for example be recommendations to supress, ‘pre- and de-bunk’ or censor alleged medical ‘mis- or disinformation’ as defined by the WHO,²¹³ stifling results-open scientific (and medical) debate, including about risks of real and immediate harm; coercing, enticing or otherwise pressurising individuals into taking investigational EUL vaccines in violation of informed consent, the HRS and other human rights; or following WHO’s recommendation to advertise the products as ‘safe and effective’ when the full clinical trials can no longer be finished, and clear safety signals are present.²¹⁴ Open and fully transparent parliamentary debates must, of course, also take account of considerations other than the data derived from limited clinical trials, such as financial, economic, cultural, religious, ethical or social considerations, and the general disease burden within a society. This guards against the danger that (risks of) harm and (opportunities for) benefits of science and the ways to diligently address the harms and promote the benefits are exclusively evaluated scientifically by scientists (or ‘experts’) themselves – a danger that should be guarded against to prevent the further ‘technocratisation’ of decision-making processes that may lead to one-sided decisions and replace other modes of (normative) reason giving.²¹⁵

Regarding b) (and related to a)), in line with state anticipation duties outlined above, scientific freedom to investigate and research alternatives to mRNA/DNA-based vaccines should be upheld by law and in practice, as should freedom of expression and the right to receive and impart scientific information on the mRNA/DNA-based vaccines and any other research activities. This would entail also general legislation requiring public and private entities conducting scientific or medical research to publish the results of clinical trials, including all details on negative outcomes; and to ensure that these results are not manipulated. Such practices by e.g. pharmaceutical corporations undermine both the general openness of science as a participatory process and the ability to evaluate and understand harm and risks of harm connected to various scientific or medical research and its outcomes.²¹⁶ Openness and publication should be the norm, even if the research is conducted for profit and thus commercial secrets may be involved; or even if the research is conducted in the context of a health emergency. Moreover, the stringent protection of prior free and informed consent of participants in scientific or medical research as well as of other routine ethics approval procedures for scientific research projects must be upheld by law to prevent real and immediate harm to individuals. Legislation would need to ensure that careful monitoring of known and unknown short- and long-term harm and risks associated with the administration of a novel investigational medical product is conducted by a specialised domestic agency, e.g. a medical regulator. Last but not least, to effectively protect against harm, states would need to coordinate the implementation and enforcement of the mentioned duties to ensure the enjoyment of science as a communal (public) good.

• b) Specialised domestic institutions

Specialised domestic institutions are required to enable states to implement their anticipation duties under the HRS too. They should be set up through legislation adopted by a legislature, but their further self-regulation on the conduct of science as a participative and communal endeavour should be encouraged, including around the anticipation of the (risks of) harm of the scientific research they are engaged in and the prevention or mitigation of such (risks of) harm. Independence and self-regulation of specialised institutions will contribute to upholding scientific freedom, and promote transparency, enabling such agencies and institutions to also inform above-mentioned thorough, open, deliberative debates through (democratic) public institutions – be they parliaments, courts or executive institutions – around the (risks of) harm and (opportunities for) benefits of scientific endeavours.

For the context of our example, a medical agency (and/or universities or other research institutions) would need to closely examine and evaluate relevant data from clinical trials held by third parties and potentially conduct their own studies and collect their own data on the safety and effectiveness of new medical products, and inter alia inform democratic deliberation processes. They would also need to have a mandate to monitor and investigate adverse effects of newly introduced medical products, in particular when they are investigational, based on new technologies and authorised on the basis of an emergency procedure, e.g. by setting up a system to this effect, and to define clear thresholds as to when warnings must be issued and/or a novel medical product or technology must be barred from further distribution and administration. There are indications that e.g. the VEARS system set up by the US medical regulators CDC and FDA has so far not been used with regard to monitoring of the adverse effects reported in connection with the Covid-19 vaccines.²¹⁷ Given the fact that international institutions are involved in the monitoring of adverse effects too, domestic agencies should be empowered to cooperate and coordinate with and through these institutions, including by obliging them to critically evaluate the data collected through their databases like VigiAccess at WHO and EudraVigilance at EMA. At the same time, a medical agency should also engage with and evaluate data and reports from local doctors developing effective early treatment protocols using re-purposed drugs – as these doctors may also be considered to engage in the open-ended, participatory and communal process of science within their area of (medical) expertise²¹⁸ – and promote any less harmful and less risky alternative to the large-scale administration of investigational Covid-19 vaccines.

More generally, domestic medical agencies need to be given all relevant competencies and adequate public funding to independently support the legislature, executive authorities and the judiciary to protect against real and immediate harm (or risks thereof) from investigational Covid-19 vaccines, as well as any other novel medical product developed, distributed and applied to the population. Other special domestic institutions, such as an ethics council or a public research funding agency might also be required to secure the HRS.

• c) Judiciary

The domestic institutional framework also importantly comprises an independent judiciary which can offer an effective remedy to those whose HRS has been violated.²¹⁹ This includes violations of the right to be protected against the harm caused by investigational Covid-19 vaccines. Though not spelt out explicitly by the CESCR General Comment 25, to ensure that the judiciary can indeed offer an effective remedy for violations, legislative and executive authorities must give the judiciary sufficiently broad competences to review relevant decisions by public authorities, universities, PPPs and private entities, including pharmaceutical corporations, and, as much as possible, by international organisations. All forms of undue obstacles, e.g. in form of broad immunities, strong protection of commercial secrets and interests that undermine access to relevant information, limitations to hearing independent expert witnesses on scientific evidence as well as on other relevant financial, economic, cultural, religious, ethical or social considerations, etc., or problems of non-compliance with judgments, must be removed so that individuals can indeed enjoy effective judicial remedies for violations of the HRS as a matter of fact. This is all the more important because remedies offered at the international level via UN treaty bodies (i.e. the CESCR), remain very limited,²²⁰ in particular when international organisations and multinational corporations are involved, and any decisions remain difficult to enforce.

• d) Upholding the public – private divide in the domestic institutional set-up

The institutional set-up sketched out above must be public to ensure the protection of science as a communal public good. This becomes particularly important against the background of the current dominance of powerful private actors in the field of science and scientific research amounting to a de facto privatisation of most parts of the scientific enterprise, including the scientific enterprise around the investigational Covid-19 vaccines.

States’ anticipatory duties under the HRS and broader duties to secure freedom of science and the conduct of disinterested, results-open science implies that the independence of researchers, scientists and science publishers must be secured through legislation and the provision of public funding that is unconditional in that it does not push scientists and researchers towards coming to pre-determined results or focus only on specific topics or research areas. For the same reason, public funding is also required for specialised institutions discussed above, e.g. medical agencies, ethics councils, universities and other research institutions. The dominance of pharmaceutical industry funding²²¹ and funding provided by philanthropic entities like the BMGF (and its Vaccine Alliance Gavi)²²² and the Wellcome Trust (which are both highly interconnected with the pharmaceutical industry²²³), in particular in the area of medical research, scientific publishing and even media reporting,²²⁴ should be critically examined in this context, as well as the fact that domestic medical regulators are in large parts funded by the industry and these entities too.²²⁵ In addition, the appearance of more and more PPPs in which the public and the private are blurred,²²⁶ as well as phenomena like excessive lobbying,²²⁷ astroturfing²²⁸ and even regulatory capture²²⁹ of (formally) public legislatures, medical regulators and executive authorities,²³⁰ must be addressed. Arguments made that the increasingly aggressive work of lobbyists and the disproportionate influence of often globally acting profit-seeking corporations or philanthropic organisations is incompatible with the effective protection of the HRS (and human rights in general) including the democratic (public) control of the scientific enterprise should be discussed openly.²³¹ Such developments are also the result of the general trend of the systematic privatisation of activities traditionally performed by (democratic) state institutions that led to an erosion of public (state) authority.²³²

The blurring of the public and the private is furthermore present in the frequent exchange of personnel between (public) medical agencies, the big philanthropic organisations and the pharmaceutical industry,²³³ and the numerous ‘independent’ experts whose work might be funded by the industry and/or the BMGF and the Wellcome Trust. In such cases, requiring mere public declarations of conflicts of interests²³⁴ might not be enough to ensure that specialised medical agencies, universities and research institutions are clearly able to protect against the harm of science and promote its benefits, and to enjoy scientific freedom.

Standards for independence of various specialised domestic institutions informed by the HRS could be developed further by domestic courts and the CESCR through engagement with state parties to the ICESCR, e.g. via the state reporting and individual complaint procedures. IHRL standards developed on judicial independence which ensure independence of courts from both private entities and other state institutions (including financial independence) to make sure that the judiciary acts in the public interest protecting human rights, equality and democracy,²³⁵ could potentially inspire the developments of such standards.

5.2. The international public institutional framework

States should set up international public institutions in order to coordinate the (internal) specification of their anticipation duties as well as their implementation and enforcement, in particular in cases where, due to the transboundary or global nature of the potential benefits and/or the (risks of) harm of science can be promoted and/or prevented or mitigated indeed only through global co-specification of (internal) state duties and their coordinated implementation.²³⁶ In addition, international cooperation and coordination through international institutions may be required for combining resources, bundling expertise and sharing burdens of implementing states’ collective anticipatory duties under the HRS. At the same time, international institutions can become bearers of (anticipatory) responsibilities for the HRS.

As indicated above, given the highly likely laboratory origin of SARS-CoV-2, there should be widespread agreement among democratic (or democratising) states and their domestic legislatures that the severity of potential harm and the degree of risk of harm of GoF-research involving SARS-CoV (and other) viruses are very high. This agreement is expressed in the 1972 BWC, though it should be further strengthened through additional clarification of Art.1(1) BWC.²³⁷ Coordination and co-specification of (internal) state duties could happen inter alia through the Implementation Support Unit for the BWC, operating within the UN Office for Disarmament Affairs.²³⁸ Strengthening the Support Unit and possibly transforming it into an organisation with verification and redress capacities modelled on the Organisation for the Prohibition of Chemical Weapons (OPWC), the implementing body of the Chemical Weapons Convention (CWC),²³⁹ could be helpful to secure a prohibition of GoF-research globally. At the same time, anticipatory responsibilities for the HRS – in particular for supporting states of jurisdiction in their activities to protect against the harm of GoF-research – would lie with the Support Unit (or a reformed version of it), based on its capacities and in particular its expertise, knowledge and powers. Such anticipatory responsibilities could be specified in a revised BWC.

International cooperation and coordination, including the co-specification of (domestic) anticipation duties and their implementation through international organisations becomes much more difficult when there is no agreement among democratic states as to the potential benefits and (risks of) harm deriving from a particular scientific research project and / or its applications, but if promoting benefits and protecting against (risks of) harm nonetheless requires such cooperation and coordination for these benefits to materialise and (risks of) harm to be prevented or mitigated. This is aggravated in a situation where existing international organisations – for example the WHO concerned with questions of medical science in relation to global health problems – does not ‘work along egalitarian lines’ and is not ‘sufficiently participative’²⁴⁰ to ensure the equal enjoyment of the HRS of all people and is no longer a public international organisation. The example of the WHO’s strong promotion of investigational Covid-19 vaccines and the parallel suppression of early treatment protocols are an example of the dysfunction of the current international institutional framework. Nonetheless, due to its mandate, expertise and power set out in its Constitution,²⁴¹ the WHO would have anticipatory responsibilities for the HRS in the area of medical science and research.²⁴²

In principle, given that WHO lacks the democratic legitimacy of domestic institutions which are (or at least should strive to be) able to carefully balance the preferences of the equal members of a ‘democratic society’ concerning the harm and risks it is willing to take and make collective decisions accordingly, WHO will need to link back to the decisions made at the domestic level in its member states to guide its own activities. Such might happen to some extent through resolutions adopted by the annual World Health Assembly held in Geneva, resulting from an open and well-informed debate among representatives of all member states.²⁴³ However, decisions concerning PHEICs are taken almost unilaterally²⁴⁴ by the WHO Director-General, possibly with the involvement of an ‘expert’ Emergency Committee whose members are appointed by the Director-General from an IHR Expert Roster,²⁴⁵ based on technical criteria which remain rather vague.²⁴⁶ Among other, such decisions on the existence of a PHEIC trigger WHO’s EUL programme which can lead to the worldwide distribution and administration of unlicensed medical products as medical countermeasures recommended by the WHO to address the PHEIC. The potential harm and benefit of these EUL-products are evaluated by a technical TAG-EUL,²⁴⁷ and it can be assumed that their risk-benefit assessment is taken based on the perception specified in the WHO’s EUL documents that societies will tolerate less certainty about the efficacy and safety of investigational medicinal products during a PHEIC,²⁴⁸ and thus higher levels of harm or risks thereof. This can raise questions as these WHO decisions may not be in line with WHO’s anticipation responsibilities for the HRS (and potentially also for overlapping responsibilities for the right to health and for other human rights) and may contradict the decisions taken through democratic procedures at the domestic level. Concerning the example of investigational Covid-19 vaccines, it might, for example, be that in countries with young populations at very low risk from Covid-19, accepting the high degree of short- and long-term risks of potentially severe harm of rolling out an investigational gene-based vaccine to the entire population outweighs the alleged benefits to allegedly limit the spread of SARS-CoV-2;²⁴⁹ and allocating significant parts of a domestic health or science budget to the organisation of their roll-out (including via Covax) may not correspond to the actual disease burden within a particular country to be addressed as a matter of priority.

Thus, decision-making procedures that work on egalitarian lines for WHO member states and are more participatory and fully transparent, based on the input of myriad domestic institutions would need to be established at WHO. Differentiated approaches as to how the WHO decisions and recommendations are to be implemented in different countries with varying levels as to the (risks of) harm of (medical) science their ‘democratic societies’ are willing to accept would need to be found. Moreover, as bearers of anticipation responsibilities flowing the HRS, the WHO technical committees set up to issue EULs (TAG-EULs) for unlicenced medical products would need to thoroughly and openly evaluate all safety and efficacy data provided by manufacturers, or, if the accuracy of data submitted cannot be verified, mandate and closely supervise additional clinical trials.²⁵⁰ Mounting reports on serious deficits of the clinical trials conducted by some of the Covid-19 vaccine manufacturers indicate that both WHO’s TAG-EULs and Strategic Advisory Group of Experts on Immunization (SAGE)²⁵¹ may have failed to do so in the process of issuing EULs for the unlicensed products.

Once WHO recommends a certain course of action based on the outcome of a (reformed) decision-making procedure and actively promotes and distributes investigational medical products based on new technologies, monitoring and alerting to harmful adverse effects should arguably also be among WHO’s tasks complying with its anticipation responsibilities to mitigate real and immediate harm under the HRS. This should also include removal of EUL products, should it appear that their harm violates the minimum core content of the HRS and/or other overlapping human rights. Through such activities the WHO could indeed enable and support states to coordinate the implementation of their own anticipation duties. States lacking the capacities and resources for setting up sophisticated reporting and evaluation systems for adverse effects of novel WHO-recommended EUL products could indeed rely on such a system run by the WHO (like the VigiAccess database), and safety signals detected through domestic or regional systems like the US’ VEARS or the EMA’s EudraVigilance could, through cooperation, be amplified, distributed and reacted upon more promptly and effectively. However, even though the WHO announces on its website on Covid-19 vaccine safety that it ‘supports work with vaccine manufacturers, health officials in each country and other partners to monitor for any safety concerns on an ongoing basis’,²⁵² it is not clear what safety signals are required before it recommends pausing or stopping the distribution and administration of an EUL product and/or withdraws its EUL – a safety signal on which also the WHO’s Global Advisory Committee on Vaccine Safety (GACVS) can act in a foreseeable and reliable fashion. It does not appear that such thresholds have been defined in the WHO’s publicly available documents so far,²⁵³ nor is it clear how GACVS utilises the reports in VigiAccess. Considering the high numbers of reports on adverse events in VigiAccess, VEARS and EudraVigilance²⁵⁴ concerning the investigative Covid-19 vaccines, it appears that thresholds relied on in earlier mass vaccination campaigns are no longer valid. For example, in 1979 a vaccination campaign covering almost 25% of the US population at the time (about 45 million US citizens) against swine flu in the US was discontinued after 25 deaths and 362 serious neurological disorders were reported after vaccination.²⁵⁵

The WHO should also assist states in co-specifying and coordinating the implementation of duties relating to the protection and promotion of scientific freedom and open scientific debates in the medical field, and, given its expertise and power, WHO will arguably have a responsibility for the HRS in this area too. As argued above, such debates enable the understanding of potential benefits and harm of (medical) science in the first place, in particular when the development, distribution and administration of novel medical products is involved where the scope of the benefits and the severity of potential harm and degree of risk of harm remain uncertain. The WHO’s ‘infodemic management’ programme appears to contradict its responsibilities for the HRS in this area, undermining states’ ability to comply with their anticipation duties. ‘Infodemic management’ coordinated during the Covid-19 pandemic by the WHO prevented and continues to prevent an open and thorough scientific debate on many aspects of the WHO’s and its member states’ response to SARS-CoV-2.²⁵⁶ Alternative WHO mechanisms through which scientists, medical doctors and the interested public could indeed have an open scientific discussion about known and unknown harm (and risks thereof) of novel medical products and on-going alternative scientific and medical research – digitally or via in person meetings – should be established, replacing the ‘infodemic management’ programme.

Last but not least, as with domestic institutions set up to ensure the specification of anticipation duties under the HRS and their implementation, the international institutions must be public institutions. WHO’s funding structure and its ever-increasing reliance on PPPs to determine its work priorities and their delivery raise questions in this regard,²⁵⁷ including in the area of granting EULs for investigational medical products. Member states’ contributions, in particular to the non-earmarked budget, shrank continuously over the years, with private actors such as the BMGF and Gavi among the biggest contributors to WHO’s 2020–23 budgets; and pharmaceutical companies also among the contributors.²⁵⁸ As indicated: BMGF, Gavi and the Wellcome Trust are highly intertwined with the pharmaceutical industry.²⁵⁹ Gavi is an observer in many WHO technical committees, including for example in SAGE²⁶⁰ and GACVS,²⁶¹ and – despite being structured as a PPP – has been granted privileges and immunities in 2009.²⁶² Against the background of WHO industry-bias during the 2009 Swine Flu pandemic,²⁶³ these developments must be evaluated critically if the HRS is to be realised in the medical-scientific field with the support of the WHO.

6. Concluding remarks

This piece made an initial attempt to sketch the domestic and international institutional framework that states shall set up to implement their anticipatory duties flowing from the HRS and, at the same time, enable international institutions to comply with their anticipatory responsibilities for the HRS. The example of the scientific response to the appearance of SARS-CoV-2 in late 2019 has been used to concretise this framework including by highlighting the shortcomings of the current framework.

Building on the understanding of science as a communal and open-ended endeavour of knowledge seeking in which everyone has a right to participate, to benefit from and to be protected against harm arising from it, as well as the importance of scientific freedom, the piece elaborated on states’ duties under the HRS to anticipate both the benefits and harm of science, and to promote the former and protect against the latter with reasonable care (due diligence). These duties encompass more positive duties to ‘protect’ and to ‘fulfil’ as well as more negative duties to ‘respect’. Their exact shape must be determined in context, taking account of many aspects, e.g. the severity of potential harm and the degree of risk of harm, the size of expected benefits and the likelihood of them to materialise, the availability of resources, the (collective) social, cultural, religious, economic or financial preferences that a certain ‘democratic society’ has and the control that the respective state institutions of jurisdiction as anticipation duty-bearers have over (opportunities for) benefits and (risks of) harm of science. The specification of anticipation duties shall be done through informed democratic (participative) processes, respecting the political equality of all members of ‘democratic societies’ and the cores of their human rights. They may, however, also involve the expertise of specialised domestic institutions.

Domestic and international institutions are thus required to (co-)specify anticipatory duties under the HRS and coordinate their implementation. Domestic public institutions, in particular legislatures, remain key here, as they can indeed exercise democratic control over and shape the domestic communal scientific endeavour including the promotion of its benefits and the protection against harm resulting from it along egalitarian lines. Of course, an independent judiciary and domestic specialised public institutions, e.g. a medical agency, a science funding institution, an ethics council, etc. are also required to carefully identify, determine and secure the anticipation duties under the HRS. The example of GoF-research with SARS-CoV viruses, the large-scale roll-out of investigational vaccines and the suppression of effective early treatment protocols for Covid-19 and the harm this has caused illustrated however that even at domestic level, the institutional framework in many countries has been unable to comply with its anticipation duties under the HRS. A significant problem in this context is the general privatised and commercialised character of the current scientific enterprise which leads to a situation in which domestic institutions do no longer have access to all relevant knowledge, data and expertise to openly debate and assess the benefits and harm of science and to allocate sufficient public resources to fund results-open scientific projects. Moreover, the public – private divide is threatened by excessive lobbying, astroturfing and regulatory capture of (formally) public institutions, as well as the extensive reliance on PPPs or the outright privatisation of scientific processes and activities. Efforts towards ensuring true democratic control over public institutions, going beyond the requirement that single persons must declare their conflicts of interests should be taken to secure the HRS institutionally at the domestic level. In addition, more research is needed to clarify the best modes of interaction between independent specialised domestic (science) institutions like universities, research institutions and medical agencies on the one hand and legislatures, executive authorities and judiciaries on the other hand in order to indeed secure the effective prevention or mitigation of (risks of) harm and the promotion of (opportunities for) benefits of science in line with the (local) preferences of the respective democratic societies represented in, and acting through, these institutions.

The analysis then revealed that the problems are aggravated at the level of international institutions which should, in principle, enable states to co-specify their domestic anticipation duties under the HRS and to coordinate their implementation. This is essential when protection against (risk of) harm and promotion of (opportunities for) benefits of science is possible only through such cooperation and coordination due to the global nature of the harm and benefit, and, more generally, due to the communal character of science underlying the HRS. To effectively comply with their anticipatory responsibilities for the HRS, international institutions would need to work along egalitarian lines too. At the very least, this would mean that decisions taken by international institutions on the promotion of some scientific innovations and the suppression of others are linked to the decisions taken by democratic states, and that these international institutions clearly remain public institutions. However, further institutional innovation is called for.

Future research should thus engage in more detail with the question of international institutional design in particular, ensuring that these institutions are public institutions, work with respect for the sovereign equality of all states, offer additional opportunities for public participation and genuinely promote scientific freedom, the openness of science and its benefits, and protect against its harm. This is essential to secure the HRS with science as a (global) communal endeavour that leads humanity to use science and its applications with discernment.

Acknowledgement

The author would like to thank Samantha Besson, Mylene Bidault Abdulle and the anonymous reviewers for their very helpful comments on earlier versions of this contribution, as well as Silvia Behrendt for enlightening conversations about recent developments concerning the WHO. All remaining errors are of course my own.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Notes on contributors

Amrei Müller

Dr Amrei Müller is currently Lecturer/Assistant Professor (Ad Astra fellow) at University College Dublin, Sutherland School of Law.

Notes

1 Art.15(1)(b) International Covenant on Economic, Social and Cultural Rights (ICESCR), 993 UNTS 3, entered into force 3 January 1976; Art.27(1) Universal Declaration of Human Rights (UDHR), UNGA Res 217A, 10 Dec 1948.

2 CESCR, General Comment 25 – On Science and Economic, Social and Cultural Rights, E/C.12/GC/25, 3 April 2020, paras.8 and 56; Venice Statement on the Right to Enjoy the Benefits of Scientific Progress and its Applications, 2009, paras.13(a) and (c); Report of the UN Special Rapporteur in the Field of Cultural Rights, Farida Shaheed, The Right to Enjoy the Benefits of Scientific Progress and its Applications, A/HRC/20/26, 14 May 2012, para.43.

3 Indirect privatisation would include e.g. the funding of universities and other public research institutions, as well as of (public) medical agencies and the WHO by the pharmaceutical industry and/or by philanthropic organisations like the Bill and Melinda Gates Foundation (BMGF) and its Vaccine Alliance Gavi, or the Wellcome Trust that have extensive links with the pharmaceutical industry. See also section 5.1.d) below.

4 This problem has been identified for a long time already, e.g. Venice Statement, para.5; Audrey Chapman, ‘Towards an Understanding of the Right to Enjoy the Benefits of Scientific Progress and its Applications’, Journal of Human Rights 8 (2009): 1, 19 and 23; Yvonne Donders, ‘The Right to Enjoy the Benefits of Scientific Progress: In Search of State Obligations in Relation to Health’, Medicine, Health Care and Philosophy 14 (2011): 371, 380; William Schabas, ‘Study of the Right to Enjoy the Benefits of Scientific and Technological Progress and Its Applications’, in Human Rights in Education, Science and Culture: Legal Developments and Challenges, ed. Donders and Volodin (Ashgate/UNESCO, 2007) 273, 297; Lea Shaver, ‘The Right to Science and Culture’, Wisconsin Law Review 1 (2010): 12; and Lea Shaver, ‘Ensuring that Everyone Benefits from Scientific and Technological Progress’, European Journal of Human Rights 4 (2015): 411, 417; Sebastian Porsdam Mann, Helle Porsdam and Yvonne Donders, ‘“Sleeping Beauty”: The Right to Science as a Global Ethical Discourse’, Human Rights Quarterly 42 (2020): 332, 352–3.

5 For the area of clinical research, see e.g. Jon Jureidini and Leemon McHenry, The Illusion of Evidence-Based Medicine. Exposing the Crisis of Credibility in Clinical Research (Wakefield Press, 2020); and Ben Goldacre, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients (Fourth Estate, 2012), noting that already in 2012, 90% of published clinical trials were sponsored by the pharmaceutical industry (172).

6 See e.g. Katie Pearse, ‘“Follow the Science” and other Principles of Biden’s Pandemic Response Plan’, John Hopkins University Hub, 15 January 2021, https://hub.jhu.edu/2021/01/15/biden-covid-response-hopkins-alums/; ‘Continuing to Follow the Science: An Open Letter from Pfizer Chairman and CEO Dr. Albert Bourla’, December 2021, https://www.pfizer.com/news/announcements/continuing-follow-science-open-letter-pfizer-chairman-and-ceo-dr-albert-bourla; and Gonzalo Muñoz and Nigel Topping, ‘Following the Science Means Slashing Emissions 7% per Year – Starting Now’, Climate Home News, 13 August 2021, https://climatechangenews.com/2021/08/13/following-science-means-slashing-emissions-7-per-year-now/. This slogan is misleading as there is no one science. On the contrary, the essence of science is the open-ended search for new knowledge through dialectic processes.

7 See e.g. the 2019 Strategic Partnership Framework signed between the UN and the World Economic Forum (WEF), https://www.weforum.org/press/2019/06/world-econoic-forum-and-un-sign-strategic-partnership-framework. An open letter to the UN Secretary General of 400+ civil society organisations ‘End the United Nations/World Economic Forum Partnership Agreement’ (25 September 2019), https://www.tni.org/en/article/end-the-united-nationsworld-economic-forum-partnership-agreement, observed that this agreement formalised the corporate capture of the UN, moving towards an increasingly privatised and less democratic form of global governance.

8 For a critical analysis of far-reaching privatisation of activities traditionally performed by states undermining the enjoyment of human rights and the functioning of democratic systems see Report of the UN Special Rapporteur on the Extreme Poverty and Human Rights, Philip Alston, A/73/396, 26 Sept 2018.

9 Panagis Polykretis and Peter McCullough, ‘Rational Harm-Benefit Assessments by Age Group are Required for Continued Covid-19 Vaccination’ Scandinavian Journal of Immunology 98 (2022): e13242.

10 John Cohen, ‘2020 Breakthrough of the Year: Shots of Hope’, Science, 17 December 2020.

11 There is mounting evidence that SARS-CoV-2 is the result of so-called gain-of-function (GoF) research which is most likely in violation of the 1972 UN Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (BWC), 1015 UNTS 163. See e.g. Sharon Lerner et al., ‘NIH Documents Provide New Evidence U.S. Funded Gain-of-Function Research in Wuhan’, The Intercept, 10 September 2021, https://theintercept.com/2021/09/09/covid-origins-gain-of-function-research; Katherine Eban, ‘“This Shouldn’t Happen”: Inside the Virus-Hunting Non-profit at the Center of the Lab-Leak Controversy’, Vanity Fair, 31 March 2022, https://www.vanityfair.com/news/2022/03/the-virus-hunting-non-profit-at-the-center-of-the-lab-leak-controversy; ‘Why the Chair of the Lancet’s Covid-19 Commission Thinks the US Government is Preventing a Real Investigation into the Pandemic’, interview with Prof. Jeffrey Sachs, Current Affairs, 2 August 2022, https://currentaffairs.org/2022/08/why-the-chair-of-the-covid-19-commission-thinks-the-us-government-is-preventing-a-real-investigation-into-the-pandemic; and Roland Wiesendanger, Studie zum Ursprung der Coronavirus-Pandemie, Preprint, Research Gate, February 2021, https://www.researchgate.net/publication/349302406_Studie_zum_Ursprung_der_Coronavirus-Pandemie.

12 See e.g. Andrew Bryant et al., ‘Ivermectin for Prevention and Treatment of Covid-19 Infection: A Systematic Review, Meta-Analysis, and Trial Sequential Analysis to Inform Clinical Guidelines’, American Journal of Therapeutics 28 (2021): e434; Lucy Kerr et al., ‘Regular Use of Ivermectin as Prophylaxis for COVID-19 Led Up to a 92% Reduction in COVID-19 Mortality Rate in a Dose-Response Manner: Results of a Prospective Observational Study of a Strictly Controlled Population of 88,012 Subjects’, Cureus 14, no.8 (2022): e28624; Pierre Kory et al., ‘Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19’, American Journal of Therapeutics 28, no.3 (2021): e299; Peter McCullough et al., ‘Pathophysiological Basis and Rationale for Early Treatment of SARS-CoV-2 (COVID-19) Infection’, American Journal of Medicine 134, no.1, (2021): 16; and collection of ‘Covid-19 Treatment Studies for Ivermectin’, available at https://c19ivm.org.

13 Samantha Besson, ‘Science without Borders and the Boundaries of Human Rights: Who Owes the Human Right to Science?’, European Journal of Human Rights 4 (2015): 462, 481.

14 According to its Constitution and mandate, WHO is not a global medical regulator. However, it more and more acts as one when it declares a Public Health Emergency of International Concern (PHEIC) under the International Health Regulations (IHR) (2509 UNTS 79, entered into force 15 June 2007) and subsequently issues Emergency Use Listings (EULs) to non-licensed medical products that are then distributed around the world.

15 See COVAX-facility, https://www.gavi.org/covax-facility. Covax is the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, https://www.act-a.org.

16 See: COVAX: CEPI’s response to COVID-19, https://cepi.net/covax/.

17 Cepi was wounded as a partnership between the World Economic Forum (WEF), the Norwegian and Indian governments, the Bill and Melinda Gates Foundation (BMGF) and the GlaxoSmithKline foundation and the Wellcome Trust. See: www.cepi.net/about/whoweare.

18 In line with Art.12 IHR. WHO Covid-19-Emgergency Committee (WHO-Covid-19-EC), Statement on the Second Meeting of the International Health Regulations (2005) Emergency Committee Regarding the Outbreak of Novel Coronavirus (2019-nCoV), 30 January 2020, available at: https://www.who.int/groups/covid-19-ihr-emergency-committee.

19 The IFR indicates the risk of death if infected. Overall, in 2021, Covid-19 had an average IFR of 0.15% (reduced to an average of 0.05% for people under 70). See the evolving work of John Ioannidis: John Ioannidis, ‘Infection Fatality Rate of Covid-19 Inferred from Seroprevalence Data’, Bulletin of the World Health Organization 99 (2021): 19; John Ioannidis, ‘Reconciling Estimates of Global Spread and Infection Fatality Rates of COVID-19: An Overview of Systematic Evaluations’, European Journal of Clinical Investigation 51, no.5 (2021): 1; and Angelo Maria Pezzullo et al., ‘Age-stratified Infection Fatality Rate of COVID-19 in the Non-elderly Population’, Environmental Research 216 (2022): 114655, concluding that the median IFR was 0.0003% at 0–19 years, 0.002% at 20–29 years, 0.011% at 30–39 years, 0.035% at 40–49 years, 0.123% at 50–59 years, and 0.506% at 60–69 years. To compare: Seasonal influenza has an average IFR of 0,16%, Ebola of 50%.

20 WHO-Covid-19-EC, Statement on the Fifteenth Meeting of the International Health Regulation (2005) Emergency Committee on the Covid-19 Pandemic, 5 May 2023, available at: https://www.who.int/groups/covid-19-ihr-emergency-committee.

21 In accordance with Arts.15–17 IHR. WHO recommendations for medical and non-medical countermeasures to address the Covid-19-PHEIC are available at: https://www.who.int/groups/covid-19-ihr-emergency-committee.

22 See e.g. WHO, Non-pharmaceutical Public Health Measures for Mitigating the Risk and Impact of Epidemic and Pandemic Influenza, 19 September 2019. For more details and fully developed arguments, see Silvia Behrendt and Amrei Müller, ‘Do we Need to Protect the Entire World Population from Health Threats through One Global Biomedical Surveillance and Response System? A Human Rights-Based Comment on the Proposed WHO Treaty on Pandemic Preparedness and Response’, German Yearbook of International Law 64 (2021): 41, 69–72.

23 For a detailed anaylsis, including the integration of the GHS into international health law, see Behrendt/Müller, ‘Do we Need’; Silvia Behrendt and Amrei Müller, ‘Vergisst die WHO über ihren sicherheitsfokussierten Ansatz der Covid-19-Pandemiebekämpfung den Menschenrechtsschutz?' (Teil 1), Jusletter, 20 December 2021; Silvia Behrendt and Amrei Müller, ‘Vergisst die WHO über ihren sicherheitsfokussierten Ansatz der Covid-19-Pandemiebekämpfung den Menschenrechtsschutz?’ (Teil 2), Jusletter, 24 January 2022.

24 See sources cited in supra note 11.

25 Potentially illegal under the 1972 BWC and the 1925 Geneva Gas Protocol. Art.1(1) BWC contains an exception in that it does not prohibit research with ‘microbial or other biological agents’ that is for ‘prophylactic, protective or other peaceful purposes’. This excludes research for the development of any defensive or offensive bioweapons (see e.g. Jozef Goldblat, ‘The Biological Weapons Convention’, International Review of the Red Cross 318 (1997): 251, 254). However, the US has interpreted this exception so broadly to justify its ‘defensive’ bioweapons programme that it arguably undermines the object and purpose of the BWC which, as set out in the BWC’s preamble, is to ‘exclude completely the possibility of bacteriological (biological) agents and toxins being used as weapons’ (neither offensively nor defensively). For a detailed analysis, Francis Boyle, Biowarfare and Terrorism (Clarity Press, 2005), 16–18, 69 and 71–74.

26 See ibid. the analysis of the US Biowarfare Program, involving numerous US and non-US universities as well as US federal agencies like the National Institute of Health (NIH) overseeing biomedical research and its sub-agency, the National Institute for Allergy and Infectious Diseases (NIAID), especially since 09/11; and Csaba Bence Farkas et al., ‘Analysis of the Virus SARS-CoV-2 as a Potential Bioweapon in Light of International Literature’, Military Medicine (2022), published online 16 May 2022.

27 These products are not traditional vaccines but gene therapy products and should have been classified as such by the regulatory agencies, see Helene Banoun, ‘mRNA: Vaccine or Gene Therapy? The Safety Regulatory Issues’, International Journal of Molecular Science 24 (2023): 10514.

28 WHO, Covid-19 Research and Innovation Achievements, April 2022, 6, https://www.who.int/publications/m/item/covid-19-research-and-innovation-achievements.

29 See statements by WHO European Director, Hans Kluge, 3 December 2020, htpps://www.reuters.com/article/us-health-coronavirus-who-idUSKPBN28D1K0.

30 Donald Trump: https://www.nbcnews.com/politics/donald-trump/trump-renews-praise-covid-vaccines-one-greatest-achievements-mankind-n1286551

31 Moncef Slaoui and Matthew Hepburn, ‘Developing Safe and Effective Covid Vaccines – Operation Warp Speed’s Strategy and Approach’, New England Journal of Medicine 383, no.18 (2020):1701.

32 Banoun, ‘mRNA: Vaccine or Gene Therapy?’, 1; Polykretis and McCullough, ‘Rational Harm-Benefit Assessments by Age Group’, e13242.

33 This is due to the fact that both Pfizer and Moderna disbanded their control groups in early 2021 (see EMA Committee for Medicinal Products for Human Use (CHMP), Assessment report on the annual renewal of the conditional marketing authorisation Procedure no. EMEA/H/C/005735/R/0046, https://www.ema.europa.eu/en/documents/variation-report/cominrnaty-h-c-5735-r-0137-epar-assessment-report-renewal_en.pdf; and Moderna, ‘Moderna Provides Clinical and Supply Updates on Covid-19 Vaccine Program Ahead of 2nd Annual Vaccines Day’, 13 April 2021, https://s29.q4cdn.com/435878511/files/doc_news/2021/04/13/moderna-provides-clinical-and-supply-updates-covid-19-vaccine.pdf. With this, both companies failed to comply with the requirements based on which EMA had granted their products conditional marketing authorisation. See also Banoun, ‘mRNA: Vaccine or Gene Therapy?’, 12.

34 EMA’s conditional marketing authorisation process explained: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/conditional-marketing-authorisation.

35 WHO, Emergency Use Listing Procedure, 9 August 2022, https://www.who.int/publications/m/item/emergency-use-listing-procedure; for details on WHO’s EUL procedure, see Behrendt/Müller, ‘Do we Need’, section III.B.3).

36 See: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52022XC1130(03)&from=EN

37 WHO, Status of COVID-19 Vaccines within WHO EUL/PQ Evaluation Process, 29 May 2023, https://extranet.who.int/prequal/sites/default/files/documents_files/Status_COVID_VAX_29May2023.pdf.

38 As confirmed on WHO’s Q&A website on the EUL procedure, https://www.who.int/news-room/questions-and-answers/item/coronavirus-disease-use-of-emergency-use-listing-procedure-forvaccines-against-covid-19; and e.g., BioNTech/Pfizer must submit the pivotal study results for its Covid-19 vaccine Comirnaty (C4591001) only in December 2023 (WHO, Recommendation for an Emergency Use Listing of Tozinameran (Covid-19 mRNA Vaccine (nucleoside modified)) submitted by BioNTech Manufacturing GmbH, 26 January 2021, https://extranet.who.int/prequal/sites/default/files/documents/TAG-EUL_PublicReport_BioNTech_DEC20). This is unlikely to happen as control groups have been disbanded.

39 E.g. WHO, Emergency Use Designation of COVID-19 Candidate Vaccines: Ethical Considerations for Current and Future COVID-19 Placebo-controlled Vaccine Trials and Trial Unblinding, 18 December 2020, 1 and 4, https://www.who.int/publications/i/item/WHO-2019-nCoV-Policy_Brief-EUD_placebo-controlled_vaccine_trials-2020.1; and WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation, ‘Placebo-Controlled Trials of Covid-19 Vaccines – Why we still Need Them’, New England Journal Medicine 384, no.2 (2021): e2(1), e2(1)-e2(2).

40 WHO, Emergency Use Listing Procedure, 9 August 2022, 7 (emphasis added).

41 Obtaining an EUL from WHO is a precondition for a product to then be distributed globally via Covax, see WHO, Product Eligibility under the COVAX Facility, 29 December 2020. This indicates that EUL designations can have de facto regulatory consequences.

42 See e.g. WHO-Covid-19-EC, Statement on the Eighth Meeting of the International Health Regulations (2005) Emergency Committee Regarding the Coronavirus Disease (COVID-19) Pandemic, 15 July 2021, rec.3 to State parties (10%); Statement on the Ninth Meeting of the International Health Regulations (2005) Emergency Committee Regarding the Coronavirus Disease (COVID-19) Pandemic, 26 Oct 2021, rec.3 to state parties (40%); Statement on the Tenth Meeting of the International Health Regulations (2005) Emergency Committee Regarding the Coronavirus Disease (COVID-19) Pandemic, 19 January 2022, rec.3 to state parties (70%); Statement on Twelfths Meeting of the International Health Regulations (2005) Emergency Committee Regarding the Coronavirus Disease (COVID-19) Pandemic (12 July 2022), rec.3 to states parties (‘achieve the highest possible vaccination coverage among persons at highest risk of severe disease outcomes and among persons at highest risk of exposure, health workers, the elderly and other priority groups’ including a ‘booster dose’); Statement on the Fourteenth Meeting of the International Health Regulations (2005) Emergency Committee Regarding the Coronavirus Disease (COVID-19) Pandemic, 30 January 2023, rec.1 (‘achieve 100% [vaccination] coverage of high-priority groups’). All statements available at: https://www.who.int/groups/covid-19-ihr-emergency-committee.

43 For details on these measures see Behrendt/Müller, ‘Do we Need’, section B.3; and Behrendt/Müller, ‘Vergisst die WHO (Teil 2), section 4.

44 See sources listed in supra note 12.

45 See e.g. WHO, ‘Therapeutics and Covid-19: Living Guidelines. 16 September 2022’, https://www.who.int/publications/i/item/WHO-2019-nCoV-therapeutics-2022.5

46 See the video report by Dr. Tess Lawrie concerning Ivermectin: ‘Dr. Tess Lawrie Provides an Exclusive Inside into Her Conversation with Dr. Andrew Hill’, 20 December 2021, https://worldcouncilforhealth.org/multimedia/tess-lawrie-andrew-hill/.

47 WHO, Infodemic; Tina Purnat et al. (eds), Managing Infodemics in the 21^st Century. Addressing New Public Health Challenges in the Information Ecosystem (Springer, 2023).

48 As analysed in detail by Behrendt/Müller, ‘Vergisst die WHO (Teil 1)’, 27–30; Behrendt/Müller, ‘Vergisst die WHO (Teil 2)’, 19–21. See also the recent insights from documents released by the US Centre for Disease Control (CDC) in response to requests under the US Freedom of Information Act obtained by America First Legal, ‘AFL Lawsuit Reveals Damning CDC Documents Proving Government Collusion with Big Tech to Censor Free Speech and Promote Biden Administration Propaganda’, 27 July 2022, https://aflegal.org/afl-lawsuit-reveals-damning-cdc-documents-proving-government-collusion-with-big-tech-to-censor-free-speech-and-promote-biden-administration-propaganda/.

49 WHO, ‘Combatting Misinformation Online’, https://www.who.int/teams/digital-health-and-innovation/digital-channels/combating-misinformation-online. For a description and analysis of the effects of these policies on leading doctors, scientists and professors see Yaffa Shir-Raz et al., ‘Censorship and Suppression of Covid-19 Heterodoxy: Tactics and Counter-Tactics’, Minerva 61 (2022): 407; and Paul Thacker, ‘The Journal Vaccine Publishes Study Finding Serious Side Effects of COVID-19 Vaccines, Despite Three Dodgy Fact Checks and Facebook Censoring’, Substack – The DisInformation Chronicle, 6 Sept 2022, https://disinformationchronicle.substack.com/p/the-journal-vaccine-publishes-study.

50 WHO, Covid-19 Advice for the Public: Getting Vaccinated, 13 April 2022, https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines/advice: ‘It is still possible to get COVID-19 and spread it to others after being vaccinated, so continue to do everything you can to keep yourself and others healthy.’

51 Piero Olliearo et al., ‘Covid-19 Vaccine Efficacy and Effectiveness – The Elephant (Not) in the Room’, Lancet Microbe 7, no.2 (2021): e279.

52 Especially those by BioNTech/Pfizer and Moderna, see e.g. Peter Doshi, ‘Will Covid-Vaccines Save Lives? Current Trials are not Designed to Tell Us’, British Medical Journal 371 (2020): m4037; Peter Doshi, ‘Pfizer and Moderna’s “95% Effective” Vaccines – We Need more Details and the Raw Data’, thebmjopinion, 4 January 2021; Peter Doshi, ‘Clarification: Pfizer and Modern’s “95% Effective” Vaccines – We Need more Details and the Raw Data’ thebmjopinion, 5 February 2021; and Paul Thacker, ‘Covid-19: Researcher Blows the Whistle on Data Integrity Issues in Pfizer’s Vaccine Trial’, British Medical Journal 375 (2021): n2635. See also the more recent analysis of Pfizer Documents released as a result of a request under the US Freedom of Information Act: Daily Clout (ed), Pfizer Documents Analysis Reports (2022), https://dailyclout.io/product/war-room-dailyclout-pfizer-documents-analysis-volunteers-reports/.

53 Vaccine Adverse Event Reporting System (VAERS), https://vears.hhs.gov. Current and reformatted US data at Openvears, VAERS COVID Vaccine Adverse Event Reports, https://openvaers.com/covid-data.

54 EudraVigilance, European Database of Suspected Adverse Drug Reaction Reports, https://www.adrreport.eu/en/index.html.

55 Data from WHO Database VigiAccess, concerning all Covid-19 vaccines, https://www.vigiaccess.org.

56 To compare, see Pedro Moro et al., ‘Deaths Reported to the Vaccine Adverse Event Reporting System, United States, 1997–2013’ Clinical Infectious Diseases 61, no.6 (2015): 980; and the comparative analysis of VigiAccess reports on adverse reactions after Covid-19 vaccinations with reports on adverse reactions after traditional vaccinations (14 July 2022), see Transparenztest, WHO VigiAccess Datenbank: 4.029.255 Reports mit 9.609.672 einzelnen Impf-Nebenwirkungen gemeldet, https://www.transprenztest.de/post/who-vigiaccess-datenbank-4029255-reports-mit-6960672-einzelnen-impf-nebenwirkungen.

57 As of July 2023, there is a total of 1,572,923 reports on adverse events in VEARS; 2,249,120 reports in EudraVigilance and 5,038,156 reports in VigiAccess. By far not all adverse effects are reported, see Lorna Hazell and Saad Shakir, ‘Under-reporting of Adverse Drug Reactions: A Systematic Review’, Drug Safety 29, no.5 (2006): 385, indicating an underreporting rate of 95%.

58 Joseph Fraiman et al., ‘Serious Adverse Events of Special Interest Following mRNA COVID-19 Vaccination in Randomized Trials in Adults’, Vaccines 40 (2022): 5798, finding 1 serious adverse event for each 800 vaccinees. To compare: other vaccines have been withdrawn from the market when one serious adverse occurred in one per 10,000 vaccinees, e.g. Lee Hampton et al., ‘General Determination of Causation Between Covid-19 Vaccines and Possible Adverse Effects’, Vaccines 39 (2021): 1478, 1479.

59 For a few recent reviews with concerning results, see Stephanie Seneff et al., ‘Innate Immune Suppression by SARS-CoV-2 mRNA Vaccinations: The Role of G-quadruplexes, Exosomes, and MicroRNAs’, Food and Chemical Toxicology 164 (2022): 113008; Fraiman et al., ‘Serious Adverse Events’; Aseem Malhotra, ‘Curing the Pandemic of Misinformation on Covid-19 mRNA Vaccines through Real Evidence-based Medicine – Part 1’, Journal of Insulin Resistance 5, no.1 (2022): a71 and Aseem Malhotra, ‘Curing the Pandemic of Misinformation on Covid-19 mRNA Vaccines through Real Evidence-based Medicine – Part 2’, Journal of Insulin Resistance 5, no.1 (2022): a72; Mark Skidmore, ‘The Role of Social Circle COVID–19 Illness and Vaccination Experiences in COVID–19 Vaccination Decisions: An Online Survey of the United States Population’, BMC Infectious Diseases 23 (2023): 51; Vladimir Uversky et al., ‘IgG4 Antibodies Induced by Repeated Vaccination May Generate Immune Tolerance to the SARS-CoV-2 Spike Protein’, Vaccines 11 (2023): 991; Max Schmeling et al., ‘Batch-dependent Safety of the BNT162b2 mRNA Covid-19 Vaccine’ European Journal of Clinical Investigation 53 (2023): e13998; Gretchen Vogel and Jennifer Couzin-Frankel, ‘Studies Probe Covid-19 Shots’ Link to Rare Symptoms. Details Emerge for Uncommon Cases of Neurologic Complications, Blood Pressure Swings, and Other Side Effects’, Science 381 (2023): 18; Fadi Nahab et al., Factors Associated with Stroke after Covid-19 Vaccination: A Statewide Analysis’, Frontiers in Neurology 14 (2023): 1199745; Josef Finsterer, ‘Neurological Adverse Reactions to SARS-CoV-2 Vaccines’, Clinical Psychopharmacology and Neuroscience 21, no. 2 (2023): 222.

60 As planned e.g. under Cepi’s 100 Days initiative, https://100days.cepi.net.

61 See WHO, Global Digital Health Certification Network, https://www.who.int/initiatives/global-digital-health-certification-network.

62 These directions are observable in the on-going negotiation process under the auspices of WHO of the new treaty on pandemic preparedness and response and the parallel revision of the IHR. For an analysis, see Behrendt/Müller, ‘Do we Need’; and Silvia Behrendt and Amrei Müller, The Proposed Amendments to the International Health Regulations: An Analysis, Opinio Juris, 27 Feb 2023.

63 CESCR, General Comment 25, paras.8 and 56.

64 E.g. Klaus Beiter, ‘Where Have all the Scientific and Academic Freedoms Gone? And What is ‘Adequate for Science?’ The Right to Enjoy the Benefits of Scientific Progress and its Applications’, Israel Law Review 52, no.2 (2019): 233, 283; and Donders, ‘In Search of State Obligations’, 372–3; and Jessica Wyndham and Margaret Weigers Vitullo, ‘The Right to Science – Whose Right? To What?’, European Journal of Human Rights 4 (2015): 431, section III.

65 E.g. Venice Statement, paras.13(a), (b) and (c).

66 As all other human rights, this right is held also by individuals who have not contributed directly to the scientific processes and their results. See e.g. Porsdam Mann, Porsdam and Donders, ‘Sleeping Beauty’, 336 and 343; and Hans Morten Haugen, ‘Human Rights and Technology – A Conflictual Relationship? Assessing Private Research and the Right to Adequate Food’, Journal of Human Rights 4 (2008): 224, 232.

67 Art.15(3) ICESCR; CESCR, General Comment 25, paras.13–15; Venice Statement, paras.8, 14(a) and (b); UNSR Report (2012) on HRS, paras.8 and 39–42. Discussing the ‘freedom dimension’ in particular see Beiter, ‘Where have all the Freedoms Gone?’.

68 Art.15(4) ICESCR; CESCR, General Comment 25, paras.45, 51–52, 74 and 77–84; Venice Statement, paras.12 g) and 16 d); UNSR Report (2012) on HRS, paras.8, 12, 15 and 17.

69 This participatory element is directly spelt out in Art.27 UDHR as pointed out in CESCR, General Comment 25, para.10 (including fn.6).

70 This communal element of the HRS is also underlined by the proximity of the HRS to the right to take part in cultural life set out in Art.15(1)(a) ICESCR, as recognised in CESCR, General Comment 25, paras.9–11. See also Mylene Bidault, ‘Considering the Right to Enjoy the Benefits of Scientific Progress and Its Applications As a Cultural Right. A Change in Perspective’, in The Right to Science. Then and Now, ed. Helle Porsdam and Sebastian Porsdam-Mann (CUP, 2022), 140.

71 On the notion of citizen scientists, see Effy Vayna and John Tasioulas, ‘“We the Scientists”: A Human Right to Citizen Science’, Philosophy & Technolology 28 (2015): 479.

72 As indicated by the definition of ‘science’ in the UNESCO Recommendation on Science and Scientific Researchers, UNESCO Doc 39 C/Res 85, 13 November 2017, para.1(a), a definition that was also adopted in the CESCR’s General Comment 25, para.4.

73 CESCR, General Comment 25, para.5. Note, however, that this contribution focuses primarily on natural (medical) science.

74 Ibid.

75 This distinguishes the HRS from the right to education set out in Art.13 ICESCR. See also Audrey Chapman, ‘Towards an Understanding of the Right to Enjoy the Benefits of Scientific Progress and its Applications’, Journal of Human Rights 8 (2009):1, 7.

76 See analyses by Tara Smith, ‘Scientific Purpose and Human Rights: Evaluating General Comment No 25 in Light of Major Discussions in the Travaux Preparatoires of the Universal Declaration on Human Rights and International Covenant on Economic, Social and Cultural Rights’, Nordic Journal of Human Rights 38, no.3 (2020): 221; and Tara Smith, ‘Understanding the Nature and Scope of the Right to Science through the Travaux Preparatoires of the Universal Declaration on Human Rights and the International Covenant on Economic, Social and Cultural Rights’, International Journal of Human Rights 24, no. 8, (2020): 1156.

77 Smith, ‘Evaluating General Comment 25’, 226–9.

78 Beiter, ‘Where Have All the Freedoms Gone?’, 250–5.

79 Ibid., 240.

80 However, with the exception of voicing some critique of granting excessively broad intellectual property rights, the CESCR does not object to the privatisation of the scientific enterprise but considers it ‘instrumental’ for the enjoyment of the HRS (see General Comment 25, paras.58–59). For a convincing argument to the contrary, though concerning the general trend to argue that a ‘human-rights-compliant regulatory regime can be transferred to the private sector’ (para.84), see Report of the UNSR on Extreme Poverty (2018).

81 Lea Shaver, ‘The Right to Science and Culture’, Wisconsin Law Review 1 (2010): 121, 128; see also Beiter, ‘Where are all the Freedoms Gone?’, warning against corporatism in science (especially the university context), 261–9 and 281 that undermines the enjoyment of HRS.

82 Of course, anyone engaging in scientific processes that result in ‘benefits and applications’ in the access to which everyone has a right to ‘benefit(s) from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author’ under Article 15(1)(c) ICESCR. As set out in CESCR, General Comment 17: The Right of Everyone to Benefit from the Protection of the Moral and Material Interests Resulting from any Scientific, Literary or Artistic Production of Which He or She is the Author, E/C.12/GC/17, 12 January 2006, this provision aims to ensure that authors enjoy an adequate standard of living and are recognised as the creators of their production (paras.12–16), but does not offer the extensive legal protection offered e.g. by current IP law (para.10).

83 CESCR, General Comment 25, para.13.

84 Ibid., paras.54–55, 75 and 87.

85 Ibid.; and UNSR Report (2012) on HRS, para.22; Venice Statement, para.16(a); and Porsdam Mann, Porsdam and Donders, ‘Sleeping Beauty’, 349.

86 Harms that potentially undermine states’ abilities to comply with minimum core obligations flowing from the HRS and other human rights cannot, of course, be justified even if ‘accepted’ through a democratic process. The inherent core of all human rights act as ‘egalitarian limits’ to democratic processes dominated by majority decisions.

87 CESCR, General Comment 25, para.56, and references to democracy in paras.37, 54 and 87; UNSR Report (2012) on HRS, paras.43 and 74(h); also implied in Venice Statement, paras.16(c) and (e).

88 UNSR Report (2012) on HRS, paras.33, 43 and 55; and Porsdam Mann, Porsdam and Donders, ‘Sleeping Beauty’, 344.

89 See e.g. Samantha Besson, ‘Human Rights and Democracy in a Global Context: Decoupling and Recoupling’, Ethics & Global Politics 4 (2011): 19.

90 Arts.2(1), 14(1), 26 ICCPR; Arts.2(2) and 3 ICESCR; Art.14 ECHR. Interpreted e.g. by HRCttee, General Comment 18 – Non-discrimination, HRI/GEN/1/Rev.1, 10 Nov 1989; CESCR, General Comment 20 – Non-discrimination in Economic, Social and Cultural Rights, E/C.12/GC/20, 2 July 2009.

91 E.g. Art.15 ICCPR; Art.15 UDHR; Art.3 P-I to the ECHR. Interpreted by HRCttee, General Comment 25 – The Right to Participate in Public Affairs, Voting Rights and the Right of Equal Access to Public Service, CCPR/C/21/Rev.1/Add.7, 12 July 1996.

92 Arts.14(1), 21 and 22(2) ICCPR; Arts 4 and 8(1)(a) and (c) ICESCR; Arts. 8(2)-11(2) ECHR.

93 CESCR, General Comment 25, paras.6 and 52.

94 Ibid., paras.13–15.

95 This follows the essential subtle distinction between duties and responsibilities Samantha Besson draws in her work, especially Besson ‘Science without Borders’, 462–85; and Samantha Besson, ‘The Bearers of Human Rights’ Duties and Responsibilities for Human Rights – A Quiet (R)Evolution’, Social Philosophy & Policy 32, no. 1 (2015): 244–68.

96 Concrete human rights duties arise for states that are parties to human rights treaties out of relationships of jurisdiction with concrete individuals, see e.g. Art.2(1) ICCPR; Art.2 OP-ICESCR; Art.1 ECHR.

97 This can be inferred from the CESCR’s reference to the precautionary principle in its General Comment 25, para.56. See also Andrea Boggio, ‘The Right to Participate in and Enjoy the Benefits of Scientific Progress and Its Applications: A Conceptual Map’, New York International Law Review 34, no.2 (2021): 43, 49; and Yvonne Donders and Monika Plozza, ‘Look Before you Leap: States’ Prevention and Anticipation Duties under the Right to Science’, 2023, in this Special Issue.

98 As at least indirectly hinted at in CESCR, General Comment 25, paras.74 and 1.

99 Curiously, the CESCR only mentions the due diligence standard in relation to states’ duties to impose this standard of conduct on international corporations, presumably via domestic private law (see CESCR, General Comment 25, para.75). It does not (directly) indicate that the due diligence standard first and foremost describes states’ duties to anticipate (risks of) harm and (opportunities for) benefits of science under the HRS. See also Samantha Besson, ‘Anticipation under the Human Right to Science: Concepts, Stakes, Specificities’, 2023, introduction to this Special Issue.

100 The duty to protect against risks of harm of science should not be confused with the duty to ‘protect’ human rights in general, referring to state duties to ensure that third parties do not interfere with the enjoyment of human rights. As elaborated on further below, the anticipation duty to protect against the risks of harm of science includes positive duties to ‘protect’ and to ‘fulfil’, as well as negative duties to ‘respect’.

101 There is no obligation of course to protect against all minute risks of science and its applications as this would be unrealistic, overburden public institutions and ultimately stifle individual freedom.

102 See e.g. in the context of the right to life protected by the ECHR: ECtHR, Osman v UK, Judgment (Grand Chamber), No 23452/94, 28 October 1998, para.116; Mastromatteo v Italy, Judgment (Grand Chamber), No 37703/97, 24 October 2002, para.68; Öneryildiz v Turkey, Judgment (Grand Chamber), No 48939/99, 30 November 2004, para.101; and in the context of the right to privacy: ECtHR, Koldayenko and Others v Russia, Judgment (Chamber), No 17423/05 et al., 28 Feb 2012, para.212.

103 See e.g. ECtHR, Koldayenko and Others v Russia, paras.162–6.

104 E.g. ECtHR, Osman v UK, para.116; O’Keeffe v Ireland, Judgment (Grand Chamber), No 35810/09, 28 January 2014, paras.144 and 162; Öneryildiz v Turkey, para.101.

105 It should be noted, however, that the CESCR in its General Comment 25 does not appear to build on these general standards of international human rights law. Instead, it refers to ‘unacceptable harm’ in para.56 which includes ‘serious and effectively irreversible harm’. Overall, this standard appears to be informed by other bodies of international law, e.g. environmental law and biomedical law. Besson, ‘Anticipation under the HRS’, introduction to this Special Issue; Donders and Plozza, ‘Look Before you Leap’, in this Special Issue.

106 See also Donders and Plozza, ‘Look Before you Leap’, in this Special Issue, on the standard of due diligence and the HRS.

107 See e.g. Explanatory Report to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, ETS No 164, Oviedo 1997, sub 14, https://rm.coe.int/16800ccde5; also recognised in CESCR, General Comment 25, para.72.

108 Donders and Plozza, ‘Look Before you Leap’, in this Special Issue.

109 CESCR, General Comment 25, para.56.

110 Art.1 BWC and Art.1 Chemical Weapons Convention (CWC), adopted 3 September 1992, 1974 UNTS 45, entered into force 29 April 1997.

111 See e.g. Art.3 EU Fundamental Rights Charter; Arts.11 and 24 UNESCO Universal Declaration on the Human Genome and Human Rights (1997); Art.13 Oviedo Convention.

112 Art.7 ICCPR recognises that this amounts to torture or inhuman or degrading treatment, and thus causes severe physical or mental pain or suffering and thus harm to human beings.

113 CESCR, General Comment 25, paras.22 and 56.

114 Ibid., para.17; this duty is also prominent in ECtHR jurisprudence concerning anticipatory duties, see e.g. ECtHR, Koldayenko and Others v Russia, para.159; and Vilnes and Others v Norway, Judgment (Chamber), No 52806/10, 5 December 2013, paras.233–44.

115 CESCR, General Comment 25, paras.18-19 and 86–87; UNSR Report (2012) on HRS, paras.51, 53 and 74(n).

116 CESCR, General Comment 25, paras.45–46 and 87.

117 For an overview see e.g. Frederick Abbott and Graham Dukes, ‘The Global Regulatory Environment’, in Global Pharmaceutical Policy: Ensuring Medicines for Tomorrow’s World, ed. Frederick Abbott and Graham Dukes (Edward Elgar, 2009), 86–115; CESCR, General Comment 25, para. 71.

118 Besson, ‘Science without Borders’, 479.

119 CESCR, General Comment 25, paras.74 and 81.

120 On the circularity and other dangers of an exclusively techno-scientific approach to anticipation duties in particular under the HRS see Besson, ‘Anticipation under the HRS’, introduction to this Special Issue.

121 CESCR, General Comment 25, para.42.

122 Ibid.

123 OHCHR, The Right to Privacy in the Digital Age, Report of the OHCHR, A/HRC/51/17, 22 August 2022, para.54.

124 Ibid.; of course, positive duties to prevent the foreseeable harm from materialising will also arise in this case.

125 CESCR, General Comment 25, paras.45, 52, 75, 84 and 89.

126 Ibid., para.87.

127 As with the prevention of harm, not every minute potential benefit from science can be promoted by states as a matter of the HRS.

128 CESCR, General Comment 25, paras.8, 14, 16, 46–47 and 86–87.

129 As indicated ibid., para.74.

130 Ibid., paras.52 and 73.

131 Ibid., para.70.

132 Ibid., para.47

133 Ibid., para.89.

134 Donders, ‘In Search of State Obligations’, 376.

135 CESCR, General Comment 25, para.42; Venice Statement, para.14(c); UNSR Report (2012) on HRS, paras.40–41.

136 CESCR, General Comment 25, paras.42 and 46; Venice Statement, para.14(a); UNSR Report (2012) on HRS, para.40; See also Beiter, ‘Where are all the Freedoms Gone?’, 248, highlighting that scientific and academic freedom should entail more robust speech rights than ‘normal’ freedom of expression because science thrives to reveal truth and new knowledge for the advancement of society, speaking out about which can expose scholars and scientists to undue attacks.

137 CESCR, General Comment 25, para.50; UNSR Report (2012) on HRS, para.40.

138 CESCR, General Comment 25, paras.43–44, on duties to ‘protect’; Venice Statement, para.15(b). This includes corporations and international organisations.

139 CESCR, General Comment 25, para.46; UNSR Report (2012) on HRS, para.40; Venice Statement, para.14(c); Beiter, ‘Where are all the Freedoms Gone?’, 241–2.

140 CESCR, General Comment 25, para.87.

141 Ibid., paras.43 and 57.

142 See e.g. Venice Statement, para.16(c); CESCR, General Comment 25, para.57.

143 The high stringency of this duty is due to the fact that the right not to be subjected to non-consensual medical or scientific experimentation forms part of the right not to be subjected to torture or inhuman or degrading treatment (Art.7 ICCPR), an (absolute) right which can neither be limited nor derogated from. See also Donders, ‘In Search of State Obligations’, 377.

144 CESCR, General Comment 25, paras.19, 22, 33, 35, 40, 43 and 71; Venice Statement, para.15(b); UNSR Report (2012) on HRS, paras.51–52; Art.16 Oviedo Convention; Art.24 Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, CETS No. 195, 2005; Art.6(2) UNESCO Universal Declaration on Bioethics and Human Rights (2005); OHCHR, UN Special Rapporteur on the Right to Health, Report on Informed Consent, A/64/272, 10 August 2010, para.35; see also Porsdman Mann, Porsdman and Donders, ‘Sleeping Beauty’, 351; and Donders, ‘In Search of Duties’, 372–73 and 377.

145 Art. 5 Oviedo Convention; Art.6(2) UNESCO Declaration (2005); John Tasioulas and Effy Vayena, ‘Getting Human Rights Right in Global Health’, The Lancet 385, no.9978 (2015): 42, 42, referring to a human right not to participate in medical experiments.

146 Art.16(v) Oviedo Convention; UNSR on the Right to Health, Report on Informed Consent, para.35.

147 Art.7 ICCPR; see also: HRCttee, Concluding Observations – US, CCPR/C/USA/CO/3/Rev.1, 2006, para.33; HRCttee, Concluding Observations – Netherlands, CCPR/CO/72/NET, 2001, para.7.

148 Art.24 Additional Protocol to Oviedo Convention; UNSR on the Right to Health, Report on Informed Consent, para.35.

149 See e.g. Nuremberg Code (1947), principle 1; Art.5 Oviedo Convention and its Explanatory Report, para.35; Art.15(2) UNESCO Declaration (2005); UNSR on the Right to Health, Report on Informed Consent, para.36.

150 See e.g. Venice Statement, para.16(c).

151 As indicated in section 3 above.

152 CESCR, General Comment 25, paras.10, 24, 35, 45 and 65; see also Venice Statement, paras.12(b), 13(a), 16(a) and (e); UNSR Report (2012) on HRS, paras.43–44; and Porsdam Mann, Porsdam and Donders, ‘Sleeping Beauty’, 344.

153 CESCR, General Comment 25, paras.8, 21, 37, 54 and 87.

154 Ibid., paras.53–55.

155 Ibid., para.57.

156 Ibid., para. 81; Venice Statement, paras.12(g), 16(d) and 17; UNSR Report (2012) on HRS, para.8.

157 Besson, ‘Science without Borders’, 479–81.

158 CESCR, General Comment 25, paras.79–80; Venice Statement, paras.12(g) and 24; UNSR Report (2012) on HRS, para.67; see also Donders, ‘In Search of Duties’, 176.

159 CESCR, General Comment 25, para.84; Venice Statement, para.15.

160 CESCR, General Comment 25, para.84; CESCR, General Comment 24 – State Obligations in the Context of Business Activities, E/C.12/GC/24, 23 June 2017, paras.31–33; UNSR Report (2012) on HRS, paras.52 and 71. There are unfortunate examples of pharmaceutical corporations conducting clinical trials in low-income countries in disregard of informed consent and other ethical principles, see e.g. Jacob Levich, ‘Disrupting Global Health: The Gates Foundation and the Vaccine Business’, in Routledge Handbook on the Politics of Global Health, ed. Richard Parker and Jonathan Garcia (Routledge, 2018), 207, 213–4.

161 CESCR, General Comment 25, para.83; and as indicated in Art.61 Draft Articles on Responsibilities of International Organisations (DARIO), 2011.

162 Responsibilities discussed here shall not be confused with secondary (remedial) responsibilities that arise once (primary) human rights duties have been violated, in accordance with the Draft Articles on Responsibilities of States for Internationally Wrongful Acts (ARSIWA), 2001.

163 Besson, ‘A Quiet (R)evolution’, 262.

164 The literature therefore sometimes refers to them as ‘secondary’ or ‘complementary’ responsibilities (‘obligations’) as opposed to the ‘primary’ obligations of states of jurisdiction, see e.g. Margot Salomon, ‘Deprivation, Causation and the Law of International Cooperation’, in Global Justice, State Duties, ed. Langford et al. (CUP, 2011), 278–9; and Wouter Vandenhole and Wolfgang Benedek, ‘Extraterritorial Human Rights Obligations and the North-South Divide’, in Global Justice, State Duties, ed. Langford et al. (CUP, 2011), at 335.

165 But see CESCR, General Comment 25, para.49, highlighting that not only states but also individuals and entities like ‘scientists, universities, publishers, scientific associations, funding agencies, libraries, the media and non-governmental institutions’ should ‘play a decisive role in the dissemination of knowledge’ and thus at least they have responsibilities in regard to this element of the HRS. There is no reason why they should not also have responsibilities for the other elements of the HRS, including protection from harmful/risky science and technology and the promotion of beneficial scientific research and its applications.

166 CESCR, General Comment 14, para.63.

167 See e.g. CESCR, General Comment 2 – International Technical Assistance Measures, contained in document E/1990/23, 1990, para.2; General Comment 11 – Plans of Action for Primary Education, E/C.12/1999/4, 11 May 1999, para.11; General Comment 12 – Right to Food, E/C.12/1999/5, 12 May 1999, para.30; General Comment 14, para.64.

168 See e.g. CESCR, Public Debt, Austerity Measures and the International Covenant on Economic, Social and Cultural Rights, Statement of the CESCR, E/C.12/2016/1, 22 July 2016, para.1.

169 E.g. CESCR, General Comment 21 – Right of Everyone to Take Part in Cultural Life, E/C.12/GC/21, 21 Dec 2009, para.73; General Comment 12, para.20; General Comment 14, para.42. See also OHCHR, Guiding Principles on Business and Human Rights, endorsed by the UN Human Rights Council, Resolution 17/6, A/HRC/RES/17/A, 6 July 2011, spelling out corporate responsibilities for human rights.

170 CESCR, General Comment 14, para.42; similarly, General Comment 12, para.20.

171 CESCR, General Comment 17, para.55.

172 CESCR, General Comment 15 – Right to Water, E/C.12/2002/11, 20 January 2002, para.60; General Comment 14, para.46.

173 E.g. Committee on the Rights of the Child (CRCttee), General Comment 5 – General Implementation Measures, CRC/GC/2003/5, 27 Nov 2003, para.64; CESCR, General Comment 15, para.60; General Comment 14, para.46; General Comment 21, para.73; General Comment 18 – Right to Work, E/C.12/GC/18, 6 Feb 2006, para.52; General Comment 24, para.5; and Guiding Principles on Business and Human Rights, Principle 11 and Commentary.

174 UN General Assembly, Declaration on the Right and Responsibility of Individuals, Groups and Organs of Society to Promote and Protect Universally Recognized Human Rights and Fundamental Freedoms, Res 53/144, 8 March 1999.

175 Ibid., Art.18(2).

176 David Miller, National Responsibility and Global Justice (OUP, 2007), 98 ff.

177 Besson, ‘Science without Borders’, 477 and 484; and Besson, ‘A Quiet (R)evolution’, 263–4.

178 See also Arts.11(1) and (2) and 23 ICESCR; and Art.4 CRC.

179 ICJ, Interpretation of the Agreement of March 1951 between the WHO and Egypt, Advisory Opinion, ICJ Reports (1980) 73, para.37; see also Arts.2(b) and 10 of the Draft Articles on the Responsibilities of International Organisations (DARIO) (2011) and commentary, p.63; and relevant academic literature, e.g. Gerhard Hafner, ‘Accountability of International Organisations – A Critical View’, in Towards World Constitutionalism, ed. Ronald St John MacDonald and Douglas Johnston (Nijhoff, 2005) 585, 629; August Reinisch, ‘Governance Without Accountability?’, German Yearbook of International Law 44 (2001): 207, 281–2.

180 Preamble, Constitution of the World Health Organization (WHOC), 14 UNTS 185, entered into force 7 April 1948; Art.3(2) IHR 2005, also cross-refers to WHOC. International organisations are bound by their constituent instrument, even if they are not parties to this instrument (see: ICJ, Reparations for Injuries Suffered in the Service of the United Nations, Advisory Opinion, ICJ Reports (1949) 174, para.180).

181 Art.3(1) IHR.

182 Whilst there is analysis of customary IHRL addressing states (e.g. William Schabas, The Customary Law of Human Rights (OUP, 2021)), to the author’s knowledge, no systematic studies on the possible customary nature of responsibilities for human rights or international organisations, let alone other non-state responsibility-bearers, have been conducted so far.

183 See e.g. CRCttee, General Comment 16 on State Obligations Regarding the Impact of the Business Sector on Children’s Rights, CRC/C/GC/16, 13 April 2013, referring to ‘practice’ in its para.8: ‘ […] the Committee recognizes that […] responsibilities to respect the rights of children extend in practice beyond the State and State-controlled services and institutions and apply to private actors and business enterprises. Therefore, all businesses must meet their responsibilities regarding children’s rights […] ’ (my emphasis). Whose ‘practice’ is of relevance here is, however, unclear, as is the need as to whether evidence of opinio iuris is also required to establish customary IHRL establishing responsibilities for human rights of non-state responsibility-bearers.

184 Maastricht Centre for Human Rights/International Commission of Jurists, Maastricht Principles on Extraterritorial Obligations of States in the Area of Economic, Social and Cultural Rights, 28 Sept 2011, https://icj2.wpenginepowered.com/wp-content/uploads/2012/05/Maastricht-Principles-analysis-brief-2011.pdf.

185 E.g. Guiding Principles on Business and Human Rights, 2011; Declaration on the Right and Responsibility of Individuals, Groups and Organs of Society, 1999; UNGA, Declaration on the Right to Development, A/RES/41/128, 4 Dec 1986; OHCHR, Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines, published in the report of the UN Special Rapporteur on the Right to Health, A/63/263, 11 August 2008. For an overview of additional documents, see Margot Salomon, Global Responsibility for Human Rights – World Poverty and the Development of International Law (OUP, 2007), 92–8.

186 Besson, ‘Science without Borders’, 484; and Besson, ‘A Quiet (R)evolution’, 263–46.

187 The need for institutions to implement the HRS is widely recognised in the literature. But there is usually little detail as to how these institutions are to be shaped, operate, cooperate, control each other etc. See e.g. Venice Statement, para.16(a); or Donders, ‘In Search of Duties’, 379. An exception is of course Besson, ‘Science without Borders’.

188 CESCR, General Comment 3 – Nature of State Parties Obligations, contained in document E/1991/23, 14 Dec 1991, para.8. Similarly, see HRCttee, General Comment 25, para.1.

189 E.g. ECtHR, Ždanoka v. Latvia, Judgment (Chamber), No 58278/00, 16 March 2006, para.98; Refah Partisi (the Welfare Party) and Others v. Turkey, Judgment (Grand Chamber), No 41340/98, 13 Feb 2003, para.86; Navalnyy v. Russia, Judgment (Chamber), No 29580/12, 15 Nov 2018, para.175.

190 Art.25(b) ICCPR; Art.3 P-I to ECHR.

191 Arts 2(3) and 14(1) ICCPR; Arts.6(1) and 10(2) ECHR.

192 E.g. ECtHR, Van de Hurk v the Netherlands, No 16034/90, 19 April 1994, paras.44–55; Animal Defenders International v. UK, No 48876/08, 22 April 2013.

193 Art.25(b) ICCPR; HRCttee, General Comment 25, paras.7, 10–12, 19 and 21.

194 HRCttee, General Comment 25, para.25; also, ECtHR, Refah Partisi v Turkey, para.89.

195 Art 2(3) ICCPR; HRCttee, General Comment 31 – Nature of the General Legal Obligation Imposed on State Parties to the Covenant, CCPR/C/21/Rev.1/Add.13, 26 May 2004, para.15; HRCttee, General Comment 25, para.20; Arts.6 and 13 ECHR.

196 See e.g. Report of the UNSR on Extreme Poverty (2018), paras.67–70 and 85–86.

197 CESCR, General Comment 25, para.86–87; UNSR Report (2012) on HRS, para.52; see also Chapman, ‘Towards an Understanding’, 21.

198 CESCR, General Comment 25, paras.49 and 87; UNSR Report (2012) on HRS, paras.43 and 74(d).

199 CESCR, General Comment 25, paras.43, 47 and 49; UNSR Report (2012) on HRS, paras.72 and 74(d).

200 See e.g. Arts.6(1), 8(c)(i), (ii), 9(1), 12(1) and (3), 13, 14(1), 15 (concerning criminal law), 17(1) and (2), 18(3), 19(3), 20, 21 and 22(2) ICCPR; Arts.4 and 8(1)(a), (c) ICESCR; and Arts.2, 5(1), (2) and (4), 6(1) and 8(2)-11(2) ECHR. On the legality standard see also Harris et al. (eds), The Law of the ECHR (OUP, 2018), 20–22; and HRCttee, General Comment 36 – The Right to Life, CCPR/C/CG/36, 18 Oct 2018, with numerous examples of legislative measures that states should adopt to protect the right to life.

201 On the approach of the ECtHR evaluating parliamentary engagement, see Matthew Saul, ‘The European Courts of Human Rights’ Margin of Appreciation and the Process of National Parliaments’, Human Rights Law Review 15, no. 4 (2015): 745.

202 See the argument by Boyle, ‘Biowarfare and Terrorism’, 16–18, 69 and 71–74.

203 Besson, ‘Science without Borders’, 479–80.

204 Implementation and Support Unit: https://www.un.org/disarmament/biological-weapons/implementation-support-unit

205 See sources listed in supra notes 12 and 46. And Gert Meeus et al., 'Efficacy and Safety of In-hospital Treatment of Covid-19 Infection with Low-dose Hydroxychloroquine and Azithromycin in Hospitalized Patients: A Retrospective Controlled Cohort Study', New Microbes and New Infections 55 (2023): 101172.

206 The low risk of these early treatment protocols is clear inter alia due to the fact that the drugs included – e.g. Ivermectin and Hydroxychloroquine – are part of WHO’s list of essential medicines, see WHO, Model List of Essential Medicines, 22nd List (2021), at https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2021.02

207 CESCR, General Comment 25, para.57.

208 Venice Statement, paras.12 (f) and 16 (c); CESCR, General Comment 25, para.56; UNSR Report (2012) on HRS, para.50.

209 See e.g. Peter Doshi, Fiona Godlee and Kamran Abbasi, ‘Covid-19 Vaccines and Treatments: We Must Have Raw Data, Now’, British Medical Journal 376 (2022): o102, noting that there are numerous legal and practical hurdles to access the raw data of Pfizer’s and Moderna’s clinical trials with Covid-19 vaccines. Therefore, in the current system, a thorough and fully transparent scrutiny and debate of the harm and risks involved appears impossible. See also more generally, Peter Doshi et al., ‘Restoring Invisible and Abandoned Trials: A Call for People to Publish the Findings’, British Medical Journal 346 (2013): f2865.

210 WHO, Emergency Use Listing Procedure, 9 August 2022, 11–14.

211 See CHMP’s website: https://www.ema.europe.eu/en/committees/committee-medicinal-products-human-use-chmp.

212 See statements of the WHO-Covid-19-EC listed in supra note 42.

213 See e.g. WHO-Covid-19-EC, Statement on the Fifth Meeting of the International Health Regulations (2005) Emergency Committee Regarding the Coronavirus Disease (COVID-19) Pandemic, 30 Oct 2020, rec.8 to state parties; Statement on the Ninth Meeting of the International Health Regulations (2005) Emergency Committee Regarding the Coronavirus Disease (COVID-19) Pandemic, 26 Oct 2021, rec.9 to state parties; Statement on the Tenth Meeting of the International Health Regulations (2005) Emergency Committee Regarding the Coronavirus Disease (COVID-19) Pandemic, 19 Jan 2022, rec.9 to state parties; and Statement on the Eleventh Meeting of the International Health Regulations (2005) Emergency Committee Regarding the Coronavirus Disease (COVID-19) Pandemic, 13 April 2022, rec.9 to state parties. All statements available at: https://www.who.int/covid-19-ihr-emergency-committee.

214 See the discussion in section 2 above.

215 This is important also in context of judicial decision-making on the HRS. See section 5.1 c) below. On that danger see also Besson, ‘Anticipation under the HRS’, introduction to this Special Issue.

216 Doshi, Godlee and Abbasi, ‘We Must Have Raw Data, Now’.

217 See Josh Guetzkov, ‘CDC Admits it Never Monitored VEARS for COVID Vaccine Safety Signal’, The Defender, 21 June 2022, https://childrenshealthdefense.org/defender/cdc-vares-vocid-vaccine-safety/.

218 Of course, such engagement in the communal process of science protected by the HRS by the medical profession is limited and shaped not only by domestic legislation but also by ethical standards, including professional ethical codes like the Hippocratic Oath. The Hippocratic Oath can be seen as an example of the self-regulatory instruments adopted by a specific epistemic community to ensure that (risks of) harm of medical research, science and treatment are prevented, monitored or otherwise controlled.

219 CESCR, General Comment 25, paras.84 and 89.

220 The number of states that ratified the Optional Protocol to the ICESCR remains low at 26 (as of 30 December 2022).

221 For a recent review, see Rebecca Strong, ‘The Anatomy of BigPharma’s Political Reach’, Brownstone Institute Articles, 8 April 2022, https://brownstone.org/articles/the-anatomy-of-big-pharmas-political-reach/. The problems with industry funding of clinical trials have been pointed out widely in the literature, see e.g. Jureidini and McHenry, The Illusion; Marcia Angell, ‘Industry-Sponsored Clinical Research: A Broke System’, Journal of the American Medical Association 300, no.9 (2008): 1069; Peter Doshi, ‘No Correction’, No Retraction, No Apology, No Comment: Paroxetine Trial Reanalysis Raises Questions about Institutional Responsibility’, British Medical Journal 351 (2015): h4629; Susanna Every-Palmer and Jeremy Howick, ‘How Evidence-Based Medicine is Failing due to Biased Trials and Selective Publication’, Journal of Evaluation in Clinical Practice 20, no.6 (2014):908.

222 See e.g. the overview of BMGF funding in the area of ‘Global Health’ for 2022, https://www.gatesfoundation.org/about/committed-grants?Division=Global%20Health&q=funding#committed_grants; see also Levich, ‘The Gates Foundation and the Vaccine Business’, 213–4.

223 See e.g. Levich, ‘The Gates Foundation and the Vaccine Business’; Tim Schwab, ‘Covid-19, Trust, and Wellcome: How Charity’s Pharma Investments Overlap with its Research Efforts’, British Medical Journal 372 (2021): n556; and Rohit Malpani, Brook Baker and Mogha Kamal-Yanni, ‘Corporate Charity – Is the Gates Foundation Addressing or Reinforcing Systemic Problems Raised by Covid-19?’, Health Policy Watch, 31 October 2020, https://www.healthpolicy-watch.news/gates-foundation-address-systemic-covid-19/.

224 See e.g. Alan MacLeod, ‘Revealed: Documents Show that Bill Gates has Given $390 Million to Media Outlets’, MintPress, 15 November 2021, https://www.mintpressnews.com/documents-show-bill-gates-has-given-319-million-to-media-outlets/278943/.

225 See e.g. the US’s CDC can accept private funding through a non-profit called the CDCFoundation. Among the funders are numerous pharmaceutical corporations (see: https://www.cdcfoundation.org/FY2021/donors?group=corp). The FDA is funded inter alia through ‘user fees’ paid by pharmaceutical companies. For an analysis see also: Strong, ‘The Anatomy’. Similar arrangements apply to EMA and national medical regulators.

226 See e.g. Ayelet Berman, ‘Industry, Regulatory Capture and Transnational Standard Setting’ AJIL Unbound 111 (2017): 112.

227 See e.g. Porsdam Mann, Porsdam and Donders, ‘Sleeping Beauty’, 335–6.

228 See e.g. Melissa Durkee, ‘Astroturf Activism’, Stanford Law Review 69 (2017): 201.

229 See e.g. contributions in Daniel Carpenter and David Moss, eds., Preventing Regulatory Capture. Special Interest Influence and How to Limit It (CUP, 2013); and Caroline Devaux, ‘Towards a Legal Theory of Capture’ European Law Journal 24 (2018): 485.

230 See e.g. Abantika Gosh, ‘“Conflict of Interest”: NHM Panel Raises Questions About Bill Gates Foundation’ Indian Express, 30 March 2016, indicating that BMGF/Gavi have ‘annexed’ health ministries in poor countries, including in India, https://indianexpress.com/article/india/india-news-india/conflict-of-interest-nhm-panel-raises-raises-questions-on-bill-gates-foundation/; and Levich, ‘The Gates Foundation and the Vaccine Business’, 212–3.

231 See e.g. Report of the UNSR on Extreme Poverty (2018), paras.70 and 84–86; see also Melissa Durkee, ‘International Lobbying Law’, The Yale Law Journal 127 (2018): 1742.

232 See ibid., for an overview of these privatisation processes that also systematically undermine states’ ability to secure human rights.

233 To name just two examples, see the role of Jeremy Farrar as director of the Wellcome Trust, member of the Trust’s internal investment committee, as member of the Scientific Advisory Group for Emergencies advising the UK government on Covid-19, as board member of Cepi (see Schwab, ‘Covid-19, Trust, and Wellcome’) and most recently, his appointment as Chief Scientist of WHO (see: https://www.who.int/news/item/13-12-2022-world-health-organization-names-sir-jeremy-farrar-as-chief-scientist-dr-amelia-latu-afuhaamango-tuipulotu-as-chief-nursing-officer); and Emer Cook, currently Head of EMA, who has been working for the European Federation of Pharmaceutical Industries and Associations (EFPIA), the biggest lobby organization of big European pharmaceutical corporations before (see: https://www.ema.europa.eu/en/about-us/who-we-are/executive-director).

234 See e.g. EMA Policy on Handling of Competing Interests of Scientific Committees’ Members and Experts, EMA/MB/89351/2020, 1 June 2020.

235 Among them through the judiciary’s ability to make binding decisions that cannot be set aside by a non-judicial entity as well as the requirement that judicial decisions must indeed be executed. Independence is also guaranteed through appropriate appointment procedures for judges ensuring their integrity, training, appropriate renumeration and tenure. See also, Basic Principles on the Independence of the Judiciary, adopted by the Seventh UN Congress on the Prevention of Crime and the Treatment of Offenders held at Milan from 26 August to 6 September 1985 and endorsed by UNGA Res 40/32, 29 Nov 1985, and UNGA Res 40/146, 13 Dec 1985.

236 CESCR, General Comment 25, para.81.

237 Art.1(1) BWC reads: ‘Each State Party to this Convention undertakes never in any circumstances to develop, produce, stockpile or otherwise acquire or retain: (1) microbial or other biological agents, or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes; […] ’.

238 BWC Implementation Support Unit, https://disarmament.unoda.org/biological-weapons/implementation-support-unit.

239 Art.8(1) CWC.

240 Besson, ‘Science without Borders’, 480.

241 Art.2 WHOC.

242 See supra notes 180–2.

243 Arts.10–23 WHOC on the role of the WHA.

244 See e.g. the decision of the WHO Director-General to declare the outbreak of monkeypox a PHEIC in July 2022, against the advice of the majority of the members of the emergency committee: WHO Monkeypox-EC, Statement on the Second Meeting of the International Health Regulations (2005) Emergency Committee Regarding the Multi-Country Outbreak of Monkeypox, 23 July 2022, https://www.who.int/news/item/23-07-2022-second-meeting-of-the-international-health-regulations-(2005)-(ihr)-emergency-committee-regarding-the-multi-country-outbreak-of-monkeypox.

245 Arts.48 and 49 IHR. It should be noted that most WHO global policies and recommendations are elaborated by expert committees.

246 Art.12 IHR and qualitative criteria for the declaration of a PHEIC are set out in Annex 2 IHR. The WHO DG’s executive authority under the IHR is unique in international law. For a critical analysis see e.g. Gian Luca Burci and Jennifer Hasselgard-Rowe, ‘Through the Rule of Law Looking Glass’, International Organizations Law Review 18, no.3 (2021): 307, 318–20.

247 See WHO, Emergency Use Listing Procedure, 9 August 2022, 11–14.

248 Ibid., 7.

249 The original promise of the 95% effectiveness of the vaccines given by the manufacturers in late 2020 have not been confirmed (see supra notes 50 and 51).

250 It does not appear that such powers are among either TAG-EUL’s (WHO, Emergency Use Listing Procedure, 9 August 2022) or SAGE’s powers (SAGE’s terms of reference, at: https://cdn.who.int/media/docs/default-source/immunization/sage/tors_sage_june2022.pdf).

251 Strategic Advisory Group of Experts on Immunization (SAGE) website: https://www.who.int/groups/strategic-advisory-group-of-experts-on-immunization/.

252 WHO’s website on Covid-19 vaccine safety makes the following general statement on safety monitoring of EUL vaccines: ‘After a COVID-19 vaccine is introduced, WHO supports work with vaccine manufacturers, health officials in each country and other partners to monitor for any safety concerns on an ongoing basis’ (at: https://www.who.int/news-room/feature-stories/detail/safety-of-covid-19-vaccines).

253 WHO’s Global Advisory Committee on Vaccine Safety (GACVS) terms of reference do not describe such thresholds (see: https://www.who.int/media/docs/default-source/pvg/global-vaccine-safety/gacvs-tor-170619.pdf). However, it appears that GACVS runs pilot projects on using AI to identify adverse events in relation to Covid-19 vaccines, see: GACVS, COVID-19 Vaccine-related Events Early Warning System, Report, 23 July 2021, https://www.who.int/groups/global-advisory-committee-on-vaccine-safety/topics/covid-19-vaccines/early-warning-system. Moreover, GACVS has issued a number of statements informing about adverse events following vaccination with investigational Covid-19 vaccines (see: https://www.who.int/groups/global-advisory-committee-on-vaccine-safety/).

254 See above, section 2.

255 Kenrad Nelson, ‘Influenza Vaccine and Guillain-Barre Syndrome – Is there a Risk?’, American Journal of Epidemiology 175, no.11 (2012): 1129; Richard Krause, ‘The Swine Flu Episode and the Fog of Epidemics’ Emerging Infectious Diseases 12, no. 1 (2006): 40; Eben Harrell, How to Deal with Swine Flu: Heeding the Mistakes of 1976, 27 April 2009, https://content.time.com/time/health/article/0,8599,1894129,00.html; and Lee Hampton et al., ‘General Determination of Causation’, 1479.

256 See section 2 above; and Kamran Abbasi, ‘Covid-19: Politization, “Corruption” and Suppression of Science’, British Medical Journal 371 (2020): m4425; Laurie Clarke, ‘Covid-19: Who Fact Checks Health and Science on Facebook?’, British Medical Journal 373 (2021): n1170; Fiona Godlee and Kamran Abbasi, ‘Open Letter from the BMJ to Mark Zuckerberg’, Rapid Response to: Covid-19: Researcher Blows the Whistle on Data Integrity Issues in Pfizer’s Vaccine Trial, British Medical Journal 275 (2021): n2636.

257 Levich, ‘The Gates Foundation and the Vaccine Business’, 214–5; Jens Martens and Karolin Seitz, ‘Philanthropic Power and Development: Who Shapes the Agenda?’, report by Global Policy Forum, November 2015, 26–36, https://archive.globalpolicy.org/images/pdfs/GPFEurope/Philantropic_Power_online.pdf; Mark Curtis, ‘Gated Development: Is the Gates Foundation Always a Force for Good?’, report by Global Justice Now, June 2016, https://www.globalpolicy.org/en/article/gated-development-gated-foundation-always-force-good; and Strong, ‘The Anatomy’.

258 WHO 2020–21 budget: https://open.who.int/2020-21/contributors/contributor; WHO 2022–23 budget: https://open.who.int/2022-23/contributors/contributor

259 See the sources in supra note 222.

260 See: https://www.who.int/groups/strategic-advisory-group-of-experts-on-immunization/about

261 See: https://www.who.int/groups/global-advisory-committee-on-vaccine-safety/working-mechanisms

262 https://www.gavi.org/news/media-room/gavi-recognised-international-institution

263 Deborah Cohen and Philip Carter, ‘Conflicts of Interest: WHO and the Pandemic Flu “Conspiracies”’, British Medical Journal 340 (2010): c2912; and Parliamentary Assembly of the Council of Europe, ‘The Handling of the H1N1 Pandemic: More Transparency Needed’, AS/Soc (2010) 12, 23 March 2010.