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.


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 indirect 3 privatisation and commercialisation of the scientific enterprise 4 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. 5Similarly, 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. 7More 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. 8he (negative) example of the ongoing global distribution of investigational vaccines against Covid-19 that are based on a novel gene-based mRNA technology 9 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 engineered 11 SARS-CoV-2 virus whilst at the same time supressing effective early treatment protocols based on re-purposed drugs 12 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'. 13he 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 Covax 15 distribution network, a public-private partnership (PPP) run jointly 16 by the WHO, the Vaccine Alliance Gavi and the Coalition for Epidemic Preparedness Innovation (Cepi). 17It 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). 18Despite 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. 20The 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. 23And indeed, there is mounting evidence that SARS-CoV-2 is a laboratory-generated virus, 24 and even the result of potentially illegal 25 bioweapons research. 26ovel mRNA-or DNA-based vaccines 27 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. 32Despite the limited data available from phase I and II clinical trials (with data from phase III clinical trials now never to be completed 33 ), and no safety and efficacy data from controlled longterm 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 BioN-Tech/Pfizer and Moderna vaccines, 36 WHO currently has 15 investigational vaccines against Covid-19 on its emergency use list. 37None 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). 39Their 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. 41Their 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. 46oreover, 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. 48The 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. 49merging 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. 52Concerning 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. 55These numbers by far exceed the number of reports on deaths occurring after the administration of conventional vaccines. 56The 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. 58These include serious adverse effects such as myocarditis/pericarditis, thrombocytopenia, anaphylactic shocks, autoimmune disorders and nervous system disorders. 59o 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 products 60 and making freedom of movement within states and across borders conditional upon the possession of digital health passports 61 to allegedly ensure GHS, these violations are likely to be repeated. 62oreover, 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.

The three-pronged scope of the HRS and science as a communal (public) good
The CESCR, 63 scholars 64 and international documents 65 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 science 67 and the need to nurture 'international contacts and co-operation in the scientific [ …] field'. 68hat 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 participate 69 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. 70In parallel, scientific freedom shall be upheld, benefitting everyone engaging directly with science and in scientific processes, including professional scientists and citizen scientists. 71This 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. 73t thrives on transparency, openness, constant questioning, reasoning, critical inquiry and evidence-based challenging of established 'truths'. 74As 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 purpose 76 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. 77As 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. 78especting and nurturing scientific freedom, scientific inquiry and result-open science will moreover enable sincere, unbiased scientific explorations through which a maximum of knowledge 79 is discovered, which, in turn, will enable enjoyment of the two other components of the HRSthe 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. 80This is in line with Lea Shaver's apt observation that under the HRS, sciencethe process, its results and applicationsshould be understood and governed 'as a global public good, rather than as private property'. 81This 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 applications 82 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. 83Rather, the three components of the HRS point to the fact that it can be determined collectivelythrough democratic processes based on political equalitywhich 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'. 85Moreover, 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. 87Thus, 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. 88This is affirmed by IHRL's grounding in the mutuality of equality, human rights and democracy, 89 which is clear from equality and non-discrimination provisions 90 as well as political participation rights 91 and numerous references to 'democratic societies'. 92It 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, openended scientific inquiries. 94

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-bearers 96 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. 97More 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. 99Other 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 protect 100 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 known 104 about them. 105Risks of real and immediate harm from science or its applications that require due diligence conduct 106 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 itself 107 (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. 108If, 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. 112If 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. 117he 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 states 118 ) may become particularly important. 119And, 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. 120hilst 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'. 123The Office of the UN High Commissioner on Human Rights (OHCHR) has described this threat as 'profoundly alarming'. 124Moreover, 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 promote 126 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. 128The 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 means 131 and its ability to overcome existing obstacles to ensuring access, availability and diffusion. 132Once 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. 138This would also entail a duty to secure the institutional autonomy and self-governance of universities 139 and other public research institutes, as well as their financial independence. 140The 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. 141omplying 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. 142This 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 stringent 143 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 experiments 145 and their right to withdraw their consent at any time 146 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'. 147btaining 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 shortterm and long-term harm and risk thereof that participation implicates. 148At 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. 149This 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 whole 151 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 dualuse 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: 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. 157The latter is the case for example when a specific (real and immediate) risk of harm of sciencee.g. the conduct of GoF researchcan 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. 158nternational 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. 159States' 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. 160ast 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. 161.2.Responsibilities to anticipate diligently (risks of) harm and (opportunities for) benefits of science Entities other than states of jurisdiction have anticipation responsibilities 162 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. 163Their scope is thus regularly determined in relation to states' jurisdiction-based anticipation duties. 164hough not elaborated on directly in General Comment 25, 165 many other General Comments of the CESCR identify international organisations like the WHO 166 and other UN organisations and specialised agencies 167 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'. 174This 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 obligationsincluding their anticipation duties under the HRSin 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 power 176 ), outcome, causality, harm, benefit or special ties. 177When 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. 179When it comes to the WHO, for instance, both the references to human rights and in particular the right to health in its Constitution 180 and references to human rights in the IHR 181 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. 182The 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 state 184 and non-state 185 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

Sketching the public institutional framework
The discussion now moves to the institutional questions: What domestic and international institutions 187 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.

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.' 189They have further specified that this implies the existence of a comprehensive unitary institutional framework consisting of an elected legislature 190 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 pluralism 194 and judicial review. 195This 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. 196Private 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 legality 200 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 debate 201 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. 202Given 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. 203Coordination 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 illness 205 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. 208Existing 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. 211Similarly, 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, 'preand de-bunk' or censor alleged medical 'misor 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. 214Open 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') themselvesa 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. 215egarding 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. 216Openness 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 institutionsbe they parliaments, courts or executive institutionsaround 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. 217Given 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 drugsas these doctors may also be considered to engage in the openended, participatory and communal process of science within their area of (medical) expertise 218 and promote any less harmful and less risky alternative to the largescale 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. 219This 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 publicprivate 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 funding 221 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 industry 223 ), 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. 225In 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 astroturfing 228 and even regulatory capture 229 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. 231Such 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. 232he 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 interests 234 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.

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. 236In 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. 237Coordination 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. 238Strengthening 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 HRSin particular for supporting states of jurisdiction in their activities to protect against the harm of GoF-researchwould 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 organisationsfor example the WHO concerned with questions of medical science in relation to global health problemsdoes 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. 242n 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. 243However, decisions concerning PHEICs are taken almost unilaterally 244 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. 246Among 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. 250Mounting 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 EULa 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 EudraVigilance 254 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. 255he 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. 256Alternative 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 researchdigitally or via in person meetingsshould 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. 258As indicated: BMGF, Gavi and the Wellcome Trust are highly intertwined with the pharmaceutical industry. 259Gavi is an observer in many WHO technical committees, including for example in SAGE 260 and GACVS, 261 anddespite being structured as a PPPhas been granted privileges and immunities in 2009. 262Against 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.

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 rollout 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 publicprivate 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.