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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.
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).
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).
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 21st 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.
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.
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Amrei Müller
Dr Amrei Müller is currently Lecturer/Assistant Professor (Ad Astra fellow) at University College Dublin, Sutherland School of Law.