On the legality of a mandatory Covid vaccination
Article by Philippe Ségur, Professor of Public Law at the University of Perpignan Via Domitia
http://www.revuedlf.com/droit-administratif/sur-la-liceite-dune-obligation-vaccinale-anti-covid/
Translated by Claire Edwards
RDLF 2021 chron. No. 20
1 July 2021
Keyword(s): consent, medical experimentation, mandatory vaccination, public health
Print or PDF version (original French)
http://www.revuedlf.com/droit-administratif/sur-la-liceite-dune-obligation-vaccinale-anti-covid/
Translated by Claire Edwards
RDLF 2021 chron. No. 20
1 July 2021
Keyword(s): consent, medical experimentation, mandatory vaccination, public health
Print or PDF version (original French)
Is it legally possible to make vaccination against Covid compulsory? Considering the marketing authorisations issued for vaccines and the applicable positive law, the answer seems negative. Indeed, the question of compulsory vaccination, although often raised, is rarely considered from the angle that it should be: that of medical experimentation, for which the rules of European Union law and French law are clearly established.
Is it legally possible to make vaccination against Covid compulsory? Considering the marketing authorisations issued for vaccines and the applicable positive law, the answer seems negative. Indeed, the question of compulsory vaccination, although often raised, is rarely considered from the angle that it should be: that of medical experimentation, for which the rules of European Union law and French law are clearly established.
Four Covid vaccines are currently authorised in France: the Moderna vaccine, the Pfizer & BioNTech vaccine (brand name: Comirnaty), the Astrazeneca vaccine (brand name: Vaxzevria) and the Johnson & Johnson vaccine (brand name: Janssen). Vaccination - a medical technique consisting of inoculating a substance capable of providing immunity against an infectious disease - is the response chosen as a priority by the French public authorities in response to the Covid-19 pandemic. In the face of resistance from part of the population, the question of whether it should be made compulsory for health care workers, or even for all French people, has entered the public debate[1].
Generally speaking, compulsory vaccination is based on several international and national texts. The International Covenant on Economic, Social and Cultural Rights of 16 December 1966 provides that in order to guarantee the “right of everyone to the enjoyment of the highest attainable standard of physical and mental health”, States shall take the necessary measures to ensure "prevention, treatment and control of epidemic, endemic, occupational and other diseases" (art. 12). In France, it is the Minister of Health who drafts the vaccination policy and the law that determines which vaccines are compulsory. Eleven are currently mandatory for children (art. L3111-2 CSP)[2]. Health professionals and embalmers are also subject to certain vaccination requirements, as are travellers who wish to visit French Guyana. It is, moreover, accepted that "when a small number of deaths occur in the context of a vaccination programme whose sole purpose is to protect the health of society by eliminating infectious diseases", this does not constitute an infringement of the right to life protected by the European Convention on Human Rights of 4 November 1950[3]. The benefits of vaccination are well documented: it has led to the eradication of smallpox, a 99% decrease in cases of polio between 1988 and 2016, and a considerable reduction in cases of tetanus, measles, diphtheria, whooping cough, etc.[4]. Conversely, the resurgence of certain lethal infectious diseases is linked to the decrease in vaccination coverage, which may justify making vaccines mandatory[5].
In a recent case, the European Court of Human Rights appeared to give assurances to states wishing to impose this obligation in the fight against Covid-19. In the Vavřička judgment of 8 April 2021, the Court held that while compulsory vaccination of children was an interference with privacy, it was necessary in a democratic society for the sake of social solidarity[6]. This ruling, together with the fact that the French government had intervened in the proceedings, was interpreted as a further argument in favour of compulsory vaccination. This is all the more so as the Constitutional Council had already refused in 2015 to declare mandatory vaccination of children against poliomyelitis, diphtheria and tetanus contrary to the Constitution[7].
The health crisis caused by the Covid-19 pandemic could therefore justify making vaccination compulsory by law for public health reasons. The exceptional nature of the circumstances should not, however, make us forget the exceptional nature of the medical means used to put an end to the crisis, i.e. the unprecedented nature of the vaccine procedures used. Thus the marketing authorisation given to the manufacturers under the accelerated procedure by the European Medicines Agency (EMA) is conditional. According to the EMA, this type of authorisation is granted "on the basis of less complete data than is normally required" and assumes that the manufacturer undertakes to "provide complete clinical data in the future". The European Public Assessment Reports (EPARs) issued within the European Medicines Agency for Pfizer[8] and Moderna[9] indicate that the pharmaceutical companies have yet to "provide the results of the main trial, which is ongoing for two years". The marketing authorisation was granted to Pfizer on 21 December 2020 until December 2022. The "final clinical study report" will be submitted in December 2023. For Moderna, authorisation was granted on 6 January 2021 until January 2023. The "final clinical study report" will be submitted in December 2022. There can therefore be no doubt that this is an experimental vaccination.
For the other two vaccines, the marketing authorisation is also conditional. The AstraZeneca vaccine was authorised on 29 January 2021 and the Johnson & Johnson vaccine on 11 March 2021. The companies marketing them will have to continue to "provide the results of the clinical trials, which are ongoing", as stated in the assessment reports of the former and the latter[10]. For AstraZeneca, the "final clinical study reports" are due on 31 May 2022[11]. For Johnson & Johnson, the final clinical study reports are due on 31 December 2023[12]. The term "clinical trial" used by the European Agency is unequivocal. This notion is defined by Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001[13]. According to this text, a clinical trial is “any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s) (…) with the object of ascertaining its (their) safety and/or efficacy". It should be noted, for example, that apart from the uncertainties relating to their specific technology - mRNA or recombinant DNA[14] – "no carcinogenicity studies have been conducted" for the Moderna vaccine and "no genotoxicity or carcinogenicity studies have been conducted" for the Pfizer, AstraZeneca and Johnson & Johnson vaccines.
All of this information is sufficient to convince us that the Covid-19 pandemic has led the health authorities to authorise a large-scale vaccine experiment that is unprecedented in the history of medicine. In times of emergency, there seems to be no legal reason why this should not be done, both from the point of view of individual health in order to protect vulnerable people and from the point of view of public health in order to avoid overburdening hospital facilities. On the other hand, the experimental nature of vaccination invites the jurist to recontextualise customary practice, because in this area, both domestic and international law have historically constructed the notion of the subject's consent as a safeguard to prevent any abuse (I). Consequently, this principle of consent seems sufficiently well established to constitute an obstacle to compulsory vaccination as long as the clinical test phases have not been completed (II).
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I - VOLUNTARY CONSENT, AN OBSTACLE TO MEDICAL EXPERIMENTATION
A - The historical conflict between ethics and medical experimentation
From the 16th century onwards, medical progress encouraged experimentation[15]. It was one of these experiments that led to the invention of the vaccine. In 1796, Dr. Edward Jenner inoculated an eight-year-old child with pus taken from a milkmaid suffering from an infectious bovine disease called smallpox. By exposing him to a contagious patient, he demonstrated that the injection had immunised the child against smallpox. Faith in progress and the glorification of scientific discoveries led to experiments on "corpus vile", considered of little value: prisoners, internees, slaves, natives and prostitutes. In the eighteenth century, doctors conducted experiments on black slaves in the European colonies of the West Indies and North America[16]. Preventative inoculation of diseases such as smallpox was used on entire populations in an attempt to achieve immunisation in a context of mass experimentation.
In the 19th century, experiments increased. Some doctors showed a high ethical awareness. In 1833, for example, an American military surgeon, William Beaumont, carried out experiments on a patient with a stomach fistula, but only after seeking his agreement and hiring him to do so[17]. In 1856, Claude Bernard, in laying down the principles of the experimental method, recommended that "no experiment should ever be performed on a man which could only be harmful to him in any degree"[18]. However, on 15 December 1859, the Lyons criminal court convicted two hospital doctors of deliberately inoculating a ten-year-old boy with syphilis when he came to the hospital with ringworm[19]. In 1884, Louis Pasteur himself wrote to the emperor of Brazil to ask for authorisation to infect death row inmates with cholera in order to test treatments on them[20]. The demands of experimentation were thus far from being synonymous with ethics. In 1892, in Germany, a doctor and clinic director was convicted of injecting syphilis into prostitutes and minors without their knowledge. Following this case, on 29 December 1900, the German health services adopted an instruction to the directors of clinics, polyclinics and hospitals requiring them to obtain the "clear consent" of the person concerned for experiments[21].
It was a French doctor, Pierre-Charles Bongrand, who first put forward the modern idea that the human subject – and not the doctor – is at the centre of experimental arrangements. In 1905, in his doctoral thesis in medicine, he noted that, while indispensable for medical progress, experiments on human beings were immoral because they sacrificed the individual to the collective. This is why he proposed establishing an agreement between the experimenter and the subject based on "prior consent"[22]. This idea was not immediately translated into legislation[23]. The principle of the patient's informed consent was first enshrined for the therapeutic relationship alone by the Court of Cassation (Court of Appeal) on 28 January 1942[24]. As for medical research, it will continue to be presupposed that it is humanistic simply because it aims to improve the lot of the collective. "The labours of men of genius, however erroneously directed, scarcely ever fail in ultimately turning to the solid advantage of mankind", wrote Mary Shelley [ironically] in Frankenstein in 1818.
However, the twentieth century has largely disproved the presupposition of the humanistic aims of all medical research. Thus Unit 731, created by Imperial Japan in 1932, is said to have killed more than ten thousand prisoners used as human laboratory guinea pigs[25]. In August 1944, the Japanese army's chief medical officer, Nakamura Hirosato, caused the death of nine hundred Indonesians after ordering the experimental injection of a vaccine containing chemically modified tetanus toxin[26]. In Germany, neither the Hippocratic Oath nor the government's directives on new therapeutics and scientific experimentation of 28 February 1931, which stipulated that experimentation was forbidden "in all cases where consent is lacking", were sufficient to prevent the most tragic medical abuses. The Third Reich carried out large-scale experiments on deported Jews. In Auschwitz, Buchenwald, Dachau and Natzwzeiler, Nazi doctors used human guinea pigs who were inoculated with pathogens such as typhus, yellow fever, smallpox, typhoid, cholera and diphtheria in order to search for vaccines or to develop treatments that would provide immunity[27].
B - The recognition of informed consent after 1947
After the Second World War, twenty Nazi doctors and three Nazi officials were accused of war crimes and crimes against humanity and tried at Nuremberg from 9 December 1946 to 20 August 1947. The judgment of the American Military Tribunal of 19 and 20 August 1947[28] established a list of ten criteria used to assess the experiments of which the defendants were accused and which are known today as the "Nuremberg Code"[29]. Among them is the principle of informed consent of the subject. In their defence, the defendants argued that in times of war, the Hippocratic oath no longer applied and that the state could decide to put the interests of science above those of the individual for the benefit of the nation. In response to this argument, the Nuremberg judges defined principles that should not depend on a specific legal anchoring – i.e. the law of a particular state – but on universal medical ethics and even international law[30]. This is why the International Covenant on Civil and Political Rights, adopted by the United Nations General Assembly on 16 December 1966, also provides that "no one shall be subjected without his free consent to medical or scientific experimentation" (art. 7).
Because of their atrocity, the crimes of the Nazi doctors led people to believe that they were a monstrous accident of history, making them forget what Hannah Arendt calls "the banality of evil". For throughout the twentieth century, other tragedies have resulted from medical experiments conducted without the consent of individuals[31]. Accounts from the United States, where such experiments are well documented, is edifying: feeding retarded children with radioactive cereals by MIT researchers at Fernald State School (Massachusetts) in the 1940s and 1950s[32], false treatment of blacks with syphilis by the Tuskegee (Alabama) Public Health Department from 1932 to 1972[33], contamination of mentally handicapped children with hepatitis by two university doctors at Willowbrook State School in New York from 1956 to 1972[34], testing thalidomide on 20,000 Americans – a sedative responsible for serious foetal malformations – on simple prescription by general practitioners at the end of the 1950s and until 1961[35], injection of cancer cells into elderly and indigent patients at the Jewish Chronicle Disease Hospital in Brooklyn in 1963[36], etc.
These examples show that for some, the end can always justify the means. This is why the World Medical Association, a non-governmental organisation of physicians created in 1947, saw fit to adopt the Declaration of Helsinki in June 1964. This was the first international text after Nuremberg to address ethical issues in experimentation. This text states that "Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary " (art. 25). In France, the principles of the Nuremberg Code largely inspire the guarantees provided by the law. They were taken up by the National Consultative Ethics Committee in an opinion issued in 1984[37]and by the Council of State's report on life sciences, ethics and law in 1988[38]. However, it was the law of 20 December 1988, known as the Huriet-Sérusclat law, which for the first time provided for specific permission for medical trials on healthy volunteers – which had previously been prohibited – while recalling the need for "free, informed and express consent"[39].
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II - FREE CONSENT, AN OBSTACLE TO COMPULSORY VACCINATION
A - The legal framework for experiments
Medical research, including when it has a therapeutic purpose, is now governed by the law of 5 March 2012, known as the Jardé law[40]. According to the Public Health Code, no interventional research involving the human being may be carried out "without his or her free and informed consent, obtained in writing, after he or she has been provided with the required information" (article 1122-1-1). Interventional research is research "which involves an intervention on the person not justified by his or her usual care" (art. 1121-1), i.e. an intervention not devoid of risk for the individuals participating in it. This includes research on medicines, but also cell therapies or gene therapies, as INSERM (French National Institute of Health and Medical Research) points out. By their nature and their experimental methodology, the four Covid vaccines seem to fall into this category. As for prior information, it must include "foreseeable risks" and "possible medical alternatives" (art. 1122-1).
Such interventional research implies a favourable judgment from a regional body, the Committee for the Protection of Persons (CPP), which comes under the Regional Health Agency (ARS), followed by authorisation by the Agence Nationale de Sécurité du Médicament et des Produits de Santé (National Agency for the Safety of Medicines and Health Products (ANSM)). In principle, failure to obtain this consent is punishable by three years' imprisonment and a fine of 45,000 euros under the Penal Code (art. 223-8). However, the question of the Covid vaccine has involved the French health authorities relinquishing control to the European Medicines Agency (EMA) on the basis of EC Regulation No. 726/2004 of 31 March 2004. With regard to "medicinal products for human use containing a new active substance", in particular for the treatment of viral diseases, this regulation provides for a centralised authorisation procedure at European level. In other words, these medicinal products must receive an authorisation from the European Medicines Agency (EMA) valid for all EU Member States. This relinquishment of responsibility prevents any action before the French courts for failure to comply with the opinion and authorisation procedure under domestic law, since under pressure of circumstances, this procedure has been replaced by a European procedure. However, it does not in any way dispense with the obligation to obtain the consent of the individuals.
Within the Council of Europe, Recommendation No. R (90) 3 of the Committee of Ministers concerning medical research on human beings, adopted on 6 February 1990, sets out a number of principles. Principle 3 states that "No medical research may be carried out without the informed, free, express and specific consent of the person undergoing it” and Principle 13 states that “Potential subjects of medical research should not be offered any inducement which compromises free consent.” This text, although it is a political and ethical commitment, is not legally binding. On the other hand, the EC Regulation of 31 March 2004 provides in a binding manner within the European Union for the respect of certain ethical requirements during the conduct of clinical trials of medicinal products authorised at European level (point 16). These requirements are provided for in Directive 2001/20/EC of 4 April 2001, which refers explicitly to the Helsinki Declaration and which also provides for informed consent (art. 3). Finally, the European Court of Human Rights ruled in 2002 that the imposition of treatment without the patient's consent is "an infringement of the physical integrity of the person concerned"[41] and that "compulsory vaccinations as non-voluntary medical treatment constitute an interference with the right to respect for private life"[42].
One question remains: does this principle apply when the experiment consists of a vaccine? The answer is yes, because the Directive of 4 April 2001 refers to medicinal products as defined by another text, Directive 65/65/EEC of 26 January 1965. According to this, a medicinal product is "Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product." (art. 1). Covid vaccines undoubtedly meet this definition. As they are still in the experimental phase, they are subject to the ethical principles imposed by the 2004 Regulation. The rule of free and informed consent to an experiment is therefore well established in both French law and European Union law.
B - Inviolability of the human body and dignity of the person
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Although the Vavřička judgment handed down by the European Court on 8 April 2021 does not prevent compulsory Covid vaccination, it does not make it plausible or legally acceptable. The case concerned vaccines that have been tried and tested over a long period of time and are only marginally contested by radical opponents of all vaccination. The same cannot be said for vaccines against Covid. As these are, by the European Medicines Agency's own admission, still in the clinical trial phase, it seems difficult to impose them in view of the existing legal guarantees. Mandating vaccination in a context of experimentation would run the risk of being sanctioned by a judge, especially since French law is based on the principle of the inviolability of the human body. This prohibition is expressed in the adage Noli me tangere, "Touch me not", taken from the words of the risen Christ to Mary Magdalene[43] and translating the sacred nature of the body. Although this principle of inviolability has not been enshrined in the Constitution, it nevertheless runs through our entire legal system and is covered by "safeguarding the dignity of the person", a broader concept that the Constitutional Council raised to the rank of a constitutional principle in its decision of 27 July 1994 concerning the law on respect for the human body[44].
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It is common to say that medical experimentation benefits the whole human race, although it may be to the detriment of those who expose themselves to its risks. In other words, the expected benefit to the many would be worth the danger to the few. However, medical experimentation on human beings cannot be reduced to an equation that would make it as obvious as a risk-benefit calculation. Indeed, such reasoning postulates its disinterested purpose by ignoring its economic, political and social determinants. In Vavřička, Judge Wojtyczek observed in a dissenting opinion published following the judgment that "no evidence was presented to the Court which would show that those States which have introduced the obligation to vaccinate perform better in terms of public health than the States which have not introduced such an obligation.” This is a crucial point with far-reaching implications.
We must beware of an idealised vision of scientific rationality that would lead us to ignore the power issues, financial interests and institutional strategies that shape it. Medical research has its own deployment logic which is not necessarily humanistic and which can be subject to the quest for profit, as the Mediator affair recently reminded us[45]. It is a fact, moreover, that pure rationality defies all moral norms and threatens to turn against itself, as Max Horkheimer has shown[46]. A marker of civilisation can then be transformed into 'regressive progress', as Theodor Adorno put it[47].
If the idea of scientific neutrality is an illusion[48], the mere use of the term “ethical” in legal texts is not enough to guarantee its harmlessness. Even when research is strictly regulated by law, the principle of free consent often seems fragile in the asymmetrical relationship between the medical authority and the subject. Moreover, it is difficult to see how consent could be completely "informed" in the presence of an unknown risk and a complex vaccination technology. As Yannick Bardie reminded us in 2016, a clinical trial is by nature "a very dangerous and unethical exercise"[49]. Given the many uncertainties that will remain unresolved until the end of the trials on the Covid vaccines, if it is legitimate to allow volunteers, especially vulnerable people, the possibility of receiving the vaccines with full knowledge of the facts involved, it would seem contrary to existing law and to the principles on which our liberal system is based to seek to impose them on all citizens.
[1] Académie nationale de médecine, « La vaccination des soignants contre la Covid-19 doit devenir obligatoire », Communiqué de l’Académie nationale de médecine, 9 mars 2021. (National Academy of Medicine, “Vaccination of caregivers against Covid-19 must be made mandatory”, Press release of the French National Academy of Medicine, 9 March 2021.)
[2] Loi n° 2017-1836 du 30 décembre 2017 de financement de la sécurité sociale pour 2018, JORF, 31 déc. 2017. (Law No. 2017-1836 of 30 December 2017 on the financing of social security for 2018, JORF, 31 Dec. 2017.)
[3] Commission EDH, 12 juill. 1978, Association X. Contre Royaume-Uni, n°7154/75. (ECHR Commission, 12 July 1978, Association X. v. United Kingdom, no. 7154/75)
[4] D. Lévy-Bruhl. « Politique vaccinale », in F. Bourdillon (dir.), Traité de santé publique. Lavoisier, 2016, pp. 311-322. (D. Lévy-Bruhl. “Vaccine policy”, in F. Bourdillon (ed.), A treatise on public health. Lavoisier, 2016, pp. 311-322.)
[5] Ph. Sansonetti, « La défiance vis-à-vis des vaccins, un luxe pour ceux qui sont protégés par les autres ? », Après-demain, vol. n° 42, n° 2, 2017, pp. 9-11. (Ph. Sansonetti, Vaccine mistrust, a luxury for those who are protected by others?”, Après-demain, vol. no. 42, no. 2, 2017, pp. 9-11.)
[6] CEDH, 8 avr. 2021, Vavřička c. République tchèque, n°46621/13. (ECHR, 8 Apr. 2021, Vavřička v. Czech Republic, no. 46621/13.)
[7] CC, déc. n° 2015-458 QPC, 20 mars 2015, Époux L. (CC, Dec. no. 2015-458 QPC, 20 March 2015, Époux L.)
[8] Comirnaty. An overview of Comirnaty and why it is authorised in the EU, EMA/215190/2021, p. 4.
[9] Covid-19 Vaccine Moderna. An overview of COVID-19 Vaccine Moderna and why it is authorised in the EU, EMA/704373/2020, p. 4.
[10] COVID-19 Vaccine Janssen. An overview of COVID-19 Vaccine Janssen and why it is authorised in the EU, EMA/229490/2021; Vaxzevria. An overview of Xaxzevria and why it is authorised in the EU, EMA/213411/2021.
[11] Committee for Medicinal Products for Human Use, Covid-19 Vaccine AstraZeneca, Assessment report, EMA/94907, 20 January 2021, p. 176.
[12] Committee for Medicinal Products for Human Use, Covid-19 Vaccine Janssen, Assessment report, EMA/158424, 11 March 2021, p. 209.
[13] Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
[14] Janssen Vaccines & Prevention B.V., Summary Notification Information Format for the Release of Genetically Modified Organisms Other Than Higher Plants in Accordance with Article 11 of Directive 2001/18/EC, Ad26COVS1, 6 July 2020.
[15] Ph. Amiel, « Expérimentation sur l’être humain », in C. Bonah, J.-M. Mouillie et al., Médecine, santé et sciences humaines, Les Belles Lettres, pp. 564-576, 2011. (Ph. Amiel, “Experimentation on human beings”, in C. Bonah, J.-M. Mouillie et al, Medicine, Health and Humanities, Les Belles Lettres, pp. 564-576, 2011.)
[16] G. Chamayou, Les corps vils. Expérimenter sur les êtres humains aux XVIIIe et XIXe siècles, La Découverte, 2014, pp. 341-384. (G. Chamayou, Vile Bodies. Experimenting on human beings in the 18th and 19th centuries, La Découverte, 2014, pp. 341-384.)
[17] W. Beaumont, Experiments and Observations on the Gastric Juice, Plattsburgh, P. P. Allen, 1833, p. 20.
[18] C. Bernard, Introduction à la médecine expérimentale, J. B. Baillère & Fils éd., 1865, II, chap. 2, § 3. (C. Bernard, Introduction to experimental medicine, J. B. Baillère & Fils ed., 1865, II, chap. 2, § 3.)
[19] A. Claudy, Histoire de la dermatologie lyonnaise, Société française d’Histoire de la dermatologie. (A. Claudy, History of dermatology in Lyons, French Society for the History of Dermatology.)
[20] L. Pasteur, Lettre adressée à Pedro II, empereur du Brésil, 22 sept. 1884, Archives Nationales, AB/XIX/3332. (L. Pasteur, Letter to Pedro II, Emperor of Brazil, 22 Sept. 1884, National Archives, AB/XIX/3332.)
[21] Schleswig-Holstein Ministerium für Soziales, Gesundheit, Jugend, Familie und Senioren, Wissenschaftliche Untersuchung der Praxis der Medikamentenversuche in schleswig-holsteinischen Einrichtungen der Behindertenhilfe sowie in den Erwachsenen-, Kinder- und Jugendpsychiatrien in den Jahren 1949 bis 1975, 12 Januar 2021, p. 35. (Schleswig-Holstein Ministry of Social Affairs, Health, Youth, Family and Senior Citizens, Scientific study of the practice of drug trials in Schleswig-Holstein institutions for the disabled and in adult, child and adolescent psychiatric institutions in the years 1949 to 1975, 12 January 2021, p. 35.)
[22] P.-C. Bongrand, L’expérimentation sur l’homme. Sa valeur scientifique et sa légitimité, 1905, Presses de l’Institut Gustave Roussy/IGR Press.fr, 2011, p. 122. (P.-C. Bongrand, Experimentation on humans. Its Scientific Value and Legitimacy, 1905, Gustave Roussy Institute Press/IGR Press.fr, 2011, p. 122.)
[23] Ph. Amiel, Des cobayes et des hommes ; expérimentation sur l’être humain et justice, Les Belles Lettres, 2011. (Ph. Amiel, Guinea pigs and humans: experimentation on human beings and justice, Les Belles Lettres, 2011.)
[24] Cass, 28 janv. 1942, Teyssier, Gaz. Pal. 1942, 1, p. 177 ; B. Hoerni et J.-P. Bouscharain, « Arrêt Teyssier de la Cour de Cassation, 28 janvier 1942 : quelques remarques sur une décision “oubliée” », Histoire des sciences médicales, t. XXXV, n°3, 2001. (Cass, 28 Jan. 1942, Teyssier, Gaz. Pal. 1942, 1, p. 177; B. Hoerni and J.-P. Bouscharain, "Teyssier ruling of the Court of Cassation, 28 January 1942: some remarks on a “forgotten” decision", History of Medical Science, t. XXXV, n°3, 2001.)
[25] R. Working, « The Trial of the Unit 731 », The Japan Times, 5 June 2005.
[26] J. K. Baird, « War Crimes in Japan-Occupied Indonesia: Unraveling the Persecution of Achmad Mochtar », The Asia-Pacific Journal Japan Focus, Jan. 1, 2016, vol. 14, issue 1, n° 4.
[27] J. Graven, « Le procès des médecins nazis et les expériences pseudo-médicales. Esquisse d’une étude de synthèse, Annales de droit international médical, n°8, juin 1962, p. 5. (Graven, "The trial of Nazi doctors and pseudo-medical experiments. Outline of a synthesis study, Annals of International Medical Law, No. 8, June 1962, p. 5.)
[28] Ph. Amiel, « Expérimentations médicales : les médecins nazis devant leurs juges », in F. Vialla, Les grandes décisions du droit médical, LGDJ, 2009, pp. 431-444. (Ph. Amiel, "Medical experiments: Nazi doctors before their judges”, in F. Vialla,
The Great Decisions of Medical Law, LGDJ, 2009, pp. 431-444.)
[29] Ph. Amiel, «Code de Nuremberg” : traductions et adaptations en français», in Des cobayes et des hommes, op. cit. (Ph. Amiel, "Nuremberg Code”: translations and adaptations into French", in Guinea Pigs and Humans, op. cit.)
[30] Ph. Amiel, F. Vialla, « Le “code de Nuremberg”, une jurisprudence pénale inaugurale endroit international de la santé », in E. Cadeau, É. Mondielli, F. Vialla (dir.), Mélanges en l’honneur de Michel Bélanger : modernité du droit de la santé, Les éditions hospitalières, 2015, pp.573-585. (Ph. Amiel, F. Vialla, "‘The Nuremberg Code’, a preliminary criminal jurisprudence in the international health field”, in E. Cadeau, É. Mondielli, F. Vialla (eds.), Selections in honour of Michel Bélanger: The modernity of health law, Les éditions hospitalières, 2015, pp.573-585.)
[31] A. M. Salam, A. S. Carr, « Racing for Covid-19 Vaccine and Cure: Lessons and Tragedies in Human Subject Research », Heart Views, 2020 Jul-Sep, 21(3), p. 229–234.
[32] R. Leung, « America’s Deep, Dark Secret », CBS News, Apr. 29, 2004.
[33] Center for Disease Control and Prevention, The Tuskegee Timeline.
[34] S. Krugman, « The Willowbrook Hepatitis Studies Revisited: Ethical Aspects », Reviews of infectious diseases, vol. 8, n°1, Jan.-Febr. 1986, 157-162.
[35] B. Fintel, A. T. Samaras, E. Carias, « The Thalidomide Tragedy: Lessons for Drug Safety and Regulation », Helix, Jul. 28, 2009.
[36] « Hospital Accused on Cancer Study », The New York Times, Jan. 21, 1964.
[37] CCNE, Avis sur les essais de nouveaux traitements chez l’homme. Réflexions et propositions, n°2, 9 oct. 1984. (CCNE, Opinion on trials of new treatments in humans. Reflections and proposals, No. 2, 9 Oct. 1984.)
[38] Sciences de la vie : de l’éthique au droit, Rapport G. Braibant, La Documentation française, 1988. (Life sciences: from ethics to law, G. Braibant Report, La Documentation française, 1988.)
[39] Loi n°88-1138 du 20 déc. 1988 relative à la protection des personnes qui se prêtent à des recherches biomédicales, JORF, 22 déc. 1988. (Law No. 88-1138 of 20 Dec. 1988 on the protection of persons who undergo biomedical research, JORF, 22 Dec. 1988.)
[40] Loi n° 2012-300 du 5 mars 2012 relative aux recherches impliquant la personne humaine, JORF, 6 mars 2012. Voir : J. Ducruet, « Protection des personnes qui se prêtent à des recherches biomédicales », Laennec, vol. 56, n°3, 2008, pp. 6-24. (Law No. 2012-300 of 5 March 2012 on research involving the human person, JORF, 6 March 2012. See: J. Ducruet, "Protection of persons undergoing biomedical research”, Laennec, vol. 56, No. 3, 2008, pp. 6-24.)
[41] CEDH, 29 avr. 2002, Pretty c. Royaume-Uni, n°2346/02. (ECHR, 29 Apr. 2002, Pretty v. UK, no. 2346/02.)
[42] CEDH, 9 juill. 2002, Salvetti C. Italie, n°42197/98. (ECHR, 9 July 2002, Salvetti v. Italy, No. 42197/98.)
[43] Jean, 20, 17.
[44] CC, déc. n° 94-343/344 DC, 27 juillet 1994, Loi relative au respect du corps humain et loi relative au don et à l’utilisation des éléments et produits du corps humain, à l’assistance médicale à la procréation et au diagnostic prénatal, JORF, 29 juill. 1994, p. 11024. (CC, Dec. No. 94-343/344 DC, 27 July 1994, Law on the respect of the human body and law on the donation and use of elements and products of the human body, on medically assisted procreation and on prenatal diagnosis, JORF, 29 July 1994, p. 11024.)
[45] CAA Paris, 8ème ch., 4 août 2017, 16PA00157 et 16PA03634. (CAA Paris, 8th ch., 4 August 2017, 16PA00157 and 16PA03634.)
[46] M. Horkheimer, Éclipse de la raison, 1947, Payot, 1974. (M. Horkheimer, The eclipse of Reason, 1947, Payot, 1974.)
[47] Th. W. Adorno, Minima Moralia. Réflexions sur la vie mutilée, 1951, Payot, 2016.
[48] K. Abbasi, “Covid-19: politicisation, ‘corruption’, and suppression of science”, The British Medical Journal, 2020, 371. Online:
www.bmj.com/content/371/bmj.m4425 (accessed 7 May 2021).
[49] L’Obs, 15 janv. 2016. Voir aussi Y. Bardie, Essai clinique : du patient à l’objet de science, Éd. Sauramps Médical, 2013. (L'Obs, 15 Jan. 2016. See also Y. Bardie, Clinical trial: from patient to science object, Editions Sauramps Médical, 2013.)
Four Covid vaccines are currently authorised in France: the Moderna vaccine, the Pfizer & BioNTech vaccine (brand name: Comirnaty), the Astrazeneca vaccine (brand name: Vaxzevria) and the Johnson & Johnson vaccine (brand name: Janssen). Vaccination - a medical technique consisting of inoculating a substance capable of providing immunity against an infectious disease - is the response chosen as a priority by the French public authorities in response to the Covid-19 pandemic. In the face of resistance from part of the population, the question of whether it should be made compulsory for health care workers, or even for all French people, has entered the public debate[1].
Generally speaking, compulsory vaccination is based on several international and national texts. The International Covenant on Economic, Social and Cultural Rights of 16 December 1966 provides that in order to guarantee the “right of everyone to the enjoyment of the highest attainable standard of physical and mental health”, States shall take the necessary measures to ensure "prevention, treatment and control of epidemic, endemic, occupational and other diseases" (art. 12). In France, it is the Minister of Health who drafts the vaccination policy and the law that determines which vaccines are compulsory. Eleven are currently mandatory for children (art. L3111-2 CSP)[2]. Health professionals and embalmers are also subject to certain vaccination requirements, as are travellers who wish to visit French Guyana. It is, moreover, accepted that "when a small number of deaths occur in the context of a vaccination programme whose sole purpose is to protect the health of society by eliminating infectious diseases", this does not constitute an infringement of the right to life protected by the European Convention on Human Rights of 4 November 1950[3]. The benefits of vaccination are well documented: it has led to the eradication of smallpox, a 99% decrease in cases of polio between 1988 and 2016, and a considerable reduction in cases of tetanus, measles, diphtheria, whooping cough, etc.[4]. Conversely, the resurgence of certain lethal infectious diseases is linked to the decrease in vaccination coverage, which may justify making vaccines mandatory[5].
In a recent case, the European Court of Human Rights appeared to give assurances to states wishing to impose this obligation in the fight against Covid-19. In the Vavřička judgment of 8 April 2021, the Court held that while compulsory vaccination of children was an interference with privacy, it was necessary in a democratic society for the sake of social solidarity[6]. This ruling, together with the fact that the French government had intervened in the proceedings, was interpreted as a further argument in favour of compulsory vaccination. This is all the more so as the Constitutional Council had already refused in 2015 to declare mandatory vaccination of children against poliomyelitis, diphtheria and tetanus contrary to the Constitution[7].
The health crisis caused by the Covid-19 pandemic could therefore justify making vaccination compulsory by law for public health reasons. The exceptional nature of the circumstances should not, however, make us forget the exceptional nature of the medical means used to put an end to the crisis, i.e. the unprecedented nature of the vaccine procedures used. Thus the marketing authorisation given to the manufacturers under the accelerated procedure by the European Medicines Agency (EMA) is conditional. According to the EMA, this type of authorisation is granted "on the basis of less complete data than is normally required" and assumes that the manufacturer undertakes to "provide complete clinical data in the future". The European Public Assessment Reports (EPARs) issued within the European Medicines Agency for Pfizer[8] and Moderna[9] indicate that the pharmaceutical companies have yet to "provide the results of the main trial, which is ongoing for two years". The marketing authorisation was granted to Pfizer on 21 December 2020 until December 2022. The "final clinical study report" will be submitted in December 2023. For Moderna, authorisation was granted on 6 January 2021 until January 2023. The "final clinical study report" will be submitted in December 2022. There can therefore be no doubt that this is an experimental vaccination.
For the other two vaccines, the marketing authorisation is also conditional. The AstraZeneca vaccine was authorised on 29 January 2021 and the Johnson & Johnson vaccine on 11 March 2021. The companies marketing them will have to continue to "provide the results of the clinical trials, which are ongoing", as stated in the assessment reports of the former and the latter[10]. For AstraZeneca, the "final clinical study reports" are due on 31 May 2022[11]. For Johnson & Johnson, the final clinical study reports are due on 31 December 2023[12]. The term "clinical trial" used by the European Agency is unequivocal. This notion is defined by Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001[13]. According to this text, a clinical trial is “any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s) (…) with the object of ascertaining its (their) safety and/or efficacy". It should be noted, for example, that apart from the uncertainties relating to their specific technology - mRNA or recombinant DNA[14] – "no carcinogenicity studies have been conducted" for the Moderna vaccine and "no genotoxicity or carcinogenicity studies have been conducted" for the Pfizer, AstraZeneca and Johnson & Johnson vaccines.
All of this information is sufficient to convince us that the Covid-19 pandemic has led the health authorities to authorise a large-scale vaccine experiment that is unprecedented in the history of medicine. In times of emergency, there seems to be no legal reason why this should not be done, both from the point of view of individual health in order to protect vulnerable people and from the point of view of public health in order to avoid overburdening hospital facilities. On the other hand, the experimental nature of vaccination invites the jurist to recontextualise customary practice, because in this area, both domestic and international law have historically constructed the notion of the subject's consent as a safeguard to prevent any abuse (I). Consequently, this principle of consent seems sufficiently well established to constitute an obstacle to compulsory vaccination as long as the clinical test phases have not been completed (II).
.
I - VOLUNTARY CONSENT, AN OBSTACLE TO MEDICAL EXPERIMENTATION
A - The historical conflict between ethics and medical experimentation
From the 16th century onwards, medical progress encouraged experimentation[15]. It was one of these experiments that led to the invention of the vaccine. In 1796, Dr. Edward Jenner inoculated an eight-year-old child with pus taken from a milkmaid suffering from an infectious bovine disease called smallpox. By exposing him to a contagious patient, he demonstrated that the injection had immunised the child against smallpox. Faith in progress and the glorification of scientific discoveries led to experiments on "corpus vile", considered of little value: prisoners, internees, slaves, natives and prostitutes. In the eighteenth century, doctors conducted experiments on black slaves in the European colonies of the West Indies and North America[16]. Preventative inoculation of diseases such as smallpox was used on entire populations in an attempt to achieve immunisation in a context of mass experimentation.
In the 19th century, experiments increased. Some doctors showed a high ethical awareness. In 1833, for example, an American military surgeon, William Beaumont, carried out experiments on a patient with a stomach fistula, but only after seeking his agreement and hiring him to do so[17]. In 1856, Claude Bernard, in laying down the principles of the experimental method, recommended that "no experiment should ever be performed on a man which could only be harmful to him in any degree"[18]. However, on 15 December 1859, the Lyons criminal court convicted two hospital doctors of deliberately inoculating a ten-year-old boy with syphilis when he came to the hospital with ringworm[19]. In 1884, Louis Pasteur himself wrote to the emperor of Brazil to ask for authorisation to infect death row inmates with cholera in order to test treatments on them[20]. The demands of experimentation were thus far from being synonymous with ethics. In 1892, in Germany, a doctor and clinic director was convicted of injecting syphilis into prostitutes and minors without their knowledge. Following this case, on 29 December 1900, the German health services adopted an instruction to the directors of clinics, polyclinics and hospitals requiring them to obtain the "clear consent" of the person concerned for experiments[21].
It was a French doctor, Pierre-Charles Bongrand, who first put forward the modern idea that the human subject – and not the doctor – is at the centre of experimental arrangements. In 1905, in his doctoral thesis in medicine, he noted that, while indispensable for medical progress, experiments on human beings were immoral because they sacrificed the individual to the collective. This is why he proposed establishing an agreement between the experimenter and the subject based on "prior consent"[22]. This idea was not immediately translated into legislation[23]. The principle of the patient's informed consent was first enshrined for the therapeutic relationship alone by the Court of Cassation (Court of Appeal) on 28 January 1942[24]. As for medical research, it will continue to be presupposed that it is humanistic simply because it aims to improve the lot of the collective. "The labours of men of genius, however erroneously directed, scarcely ever fail in ultimately turning to the solid advantage of mankind", wrote Mary Shelley [ironically] in Frankenstein in 1818.
However, the twentieth century has largely disproved the presupposition of the humanistic aims of all medical research. Thus Unit 731, created by Imperial Japan in 1932, is said to have killed more than ten thousand prisoners used as human laboratory guinea pigs[25]. In August 1944, the Japanese army's chief medical officer, Nakamura Hirosato, caused the death of nine hundred Indonesians after ordering the experimental injection of a vaccine containing chemically modified tetanus toxin[26]. In Germany, neither the Hippocratic Oath nor the government's directives on new therapeutics and scientific experimentation of 28 February 1931, which stipulated that experimentation was forbidden "in all cases where consent is lacking", were sufficient to prevent the most tragic medical abuses. The Third Reich carried out large-scale experiments on deported Jews. In Auschwitz, Buchenwald, Dachau and Natzwzeiler, Nazi doctors used human guinea pigs who were inoculated with pathogens such as typhus, yellow fever, smallpox, typhoid, cholera and diphtheria in order to search for vaccines or to develop treatments that would provide immunity[27].
B - The recognition of informed consent after 1947
After the Second World War, twenty Nazi doctors and three Nazi officials were accused of war crimes and crimes against humanity and tried at Nuremberg from 9 December 1946 to 20 August 1947. The judgment of the American Military Tribunal of 19 and 20 August 1947[28] established a list of ten criteria used to assess the experiments of which the defendants were accused and which are known today as the "Nuremberg Code"[29]. Among them is the principle of informed consent of the subject. In their defence, the defendants argued that in times of war, the Hippocratic oath no longer applied and that the state could decide to put the interests of science above those of the individual for the benefit of the nation. In response to this argument, the Nuremberg judges defined principles that should not depend on a specific legal anchoring – i.e. the law of a particular state – but on universal medical ethics and even international law[30]. This is why the International Covenant on Civil and Political Rights, adopted by the United Nations General Assembly on 16 December 1966, also provides that "no one shall be subjected without his free consent to medical or scientific experimentation" (art. 7).
Because of their atrocity, the crimes of the Nazi doctors led people to believe that they were a monstrous accident of history, making them forget what Hannah Arendt calls "the banality of evil". For throughout the twentieth century, other tragedies have resulted from medical experiments conducted without the consent of individuals[31]. Accounts from the United States, where such experiments are well documented, is edifying: feeding retarded children with radioactive cereals by MIT researchers at Fernald State School (Massachusetts) in the 1940s and 1950s[32], false treatment of blacks with syphilis by the Tuskegee (Alabama) Public Health Department from 1932 to 1972[33], contamination of mentally handicapped children with hepatitis by two university doctors at Willowbrook State School in New York from 1956 to 1972[34], testing thalidomide on 20,000 Americans – a sedative responsible for serious foetal malformations – on simple prescription by general practitioners at the end of the 1950s and until 1961[35], injection of cancer cells into elderly and indigent patients at the Jewish Chronicle Disease Hospital in Brooklyn in 1963[36], etc.
These examples show that for some, the end can always justify the means. This is why the World Medical Association, a non-governmental organisation of physicians created in 1947, saw fit to adopt the Declaration of Helsinki in June 1964. This was the first international text after Nuremberg to address ethical issues in experimentation. This text states that "Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary " (art. 25). In France, the principles of the Nuremberg Code largely inspire the guarantees provided by the law. They were taken up by the National Consultative Ethics Committee in an opinion issued in 1984[37]and by the Council of State's report on life sciences, ethics and law in 1988[38]. However, it was the law of 20 December 1988, known as the Huriet-Sérusclat law, which for the first time provided for specific permission for medical trials on healthy volunteers – which had previously been prohibited – while recalling the need for "free, informed and express consent"[39].
.
II - FREE CONSENT, AN OBSTACLE TO COMPULSORY VACCINATION
A - The legal framework for experiments
Medical research, including when it has a therapeutic purpose, is now governed by the law of 5 March 2012, known as the Jardé law[40]. According to the Public Health Code, no interventional research involving the human being may be carried out "without his or her free and informed consent, obtained in writing, after he or she has been provided with the required information" (article 1122-1-1). Interventional research is research "which involves an intervention on the person not justified by his or her usual care" (art. 1121-1), i.e. an intervention not devoid of risk for the individuals participating in it. This includes research on medicines, but also cell therapies or gene therapies, as INSERM (French National Institute of Health and Medical Research) points out. By their nature and their experimental methodology, the four Covid vaccines seem to fall into this category. As for prior information, it must include "foreseeable risks" and "possible medical alternatives" (art. 1122-1).
Such interventional research implies a favourable judgment from a regional body, the Committee for the Protection of Persons (CPP), which comes under the Regional Health Agency (ARS), followed by authorisation by the Agence Nationale de Sécurité du Médicament et des Produits de Santé (National Agency for the Safety of Medicines and Health Products (ANSM)). In principle, failure to obtain this consent is punishable by three years' imprisonment and a fine of 45,000 euros under the Penal Code (art. 223-8). However, the question of the Covid vaccine has involved the French health authorities relinquishing control to the European Medicines Agency (EMA) on the basis of EC Regulation No. 726/2004 of 31 March 2004. With regard to "medicinal products for human use containing a new active substance", in particular for the treatment of viral diseases, this regulation provides for a centralised authorisation procedure at European level. In other words, these medicinal products must receive an authorisation from the European Medicines Agency (EMA) valid for all EU Member States. This relinquishment of responsibility prevents any action before the French courts for failure to comply with the opinion and authorisation procedure under domestic law, since under pressure of circumstances, this procedure has been replaced by a European procedure. However, it does not in any way dispense with the obligation to obtain the consent of the individuals.
Within the Council of Europe, Recommendation No. R (90) 3 of the Committee of Ministers concerning medical research on human beings, adopted on 6 February 1990, sets out a number of principles. Principle 3 states that "No medical research may be carried out without the informed, free, express and specific consent of the person undergoing it” and Principle 13 states that “Potential subjects of medical research should not be offered any inducement which compromises free consent.” This text, although it is a political and ethical commitment, is not legally binding. On the other hand, the EC Regulation of 31 March 2004 provides in a binding manner within the European Union for the respect of certain ethical requirements during the conduct of clinical trials of medicinal products authorised at European level (point 16). These requirements are provided for in Directive 2001/20/EC of 4 April 2001, which refers explicitly to the Helsinki Declaration and which also provides for informed consent (art. 3). Finally, the European Court of Human Rights ruled in 2002 that the imposition of treatment without the patient's consent is "an infringement of the physical integrity of the person concerned"[41] and that "compulsory vaccinations as non-voluntary medical treatment constitute an interference with the right to respect for private life"[42].
One question remains: does this principle apply when the experiment consists of a vaccine? The answer is yes, because the Directive of 4 April 2001 refers to medicinal products as defined by another text, Directive 65/65/EEC of 26 January 1965. According to this, a medicinal product is "Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product." (art. 1). Covid vaccines undoubtedly meet this definition. As they are still in the experimental phase, they are subject to the ethical principles imposed by the 2004 Regulation. The rule of free and informed consent to an experiment is therefore well established in both French law and European Union law.
B - Inviolability of the human body and dignity of the person
.
Although the Vavřička judgment handed down by the European Court on 8 April 2021 does not prevent compulsory Covid vaccination, it does not make it plausible or legally acceptable. The case concerned vaccines that have been tried and tested over a long period of time and are only marginally contested by radical opponents of all vaccination. The same cannot be said for vaccines against Covid. As these are, by the European Medicines Agency's own admission, still in the clinical trial phase, it seems difficult to impose them in view of the existing legal guarantees. Mandating vaccination in a context of experimentation would run the risk of being sanctioned by a judge, especially since French law is based on the principle of the inviolability of the human body. This prohibition is expressed in the adage Noli me tangere, "Touch me not", taken from the words of the risen Christ to Mary Magdalene[43] and translating the sacred nature of the body. Although this principle of inviolability has not been enshrined in the Constitution, it nevertheless runs through our entire legal system and is covered by "safeguarding the dignity of the person", a broader concept that the Constitutional Council raised to the rank of a constitutional principle in its decision of 27 July 1994 concerning the law on respect for the human body[44].
.
It is common to say that medical experimentation benefits the whole human race, although it may be to the detriment of those who expose themselves to its risks. In other words, the expected benefit to the many would be worth the danger to the few. However, medical experimentation on human beings cannot be reduced to an equation that would make it as obvious as a risk-benefit calculation. Indeed, such reasoning postulates its disinterested purpose by ignoring its economic, political and social determinants. In Vavřička, Judge Wojtyczek observed in a dissenting opinion published following the judgment that "no evidence was presented to the Court which would show that those States which have introduced the obligation to vaccinate perform better in terms of public health than the States which have not introduced such an obligation.” This is a crucial point with far-reaching implications.
We must beware of an idealised vision of scientific rationality that would lead us to ignore the power issues, financial interests and institutional strategies that shape it. Medical research has its own deployment logic which is not necessarily humanistic and which can be subject to the quest for profit, as the Mediator affair recently reminded us[45]. It is a fact, moreover, that pure rationality defies all moral norms and threatens to turn against itself, as Max Horkheimer has shown[46]. A marker of civilisation can then be transformed into 'regressive progress', as Theodor Adorno put it[47].
If the idea of scientific neutrality is an illusion[48], the mere use of the term “ethical” in legal texts is not enough to guarantee its harmlessness. Even when research is strictly regulated by law, the principle of free consent often seems fragile in the asymmetrical relationship between the medical authority and the subject. Moreover, it is difficult to see how consent could be completely "informed" in the presence of an unknown risk and a complex vaccination technology. As Yannick Bardie reminded us in 2016, a clinical trial is by nature "a very dangerous and unethical exercise"[49]. Given the many uncertainties that will remain unresolved until the end of the trials on the Covid vaccines, if it is legitimate to allow volunteers, especially vulnerable people, the possibility of receiving the vaccines with full knowledge of the facts involved, it would seem contrary to existing law and to the principles on which our liberal system is based to seek to impose them on all citizens.
[1] Académie nationale de médecine, « La vaccination des soignants contre la Covid-19 doit devenir obligatoire », Communiqué de l’Académie nationale de médecine, 9 mars 2021. (National Academy of Medicine, “Vaccination of caregivers against Covid-19 must be made mandatory”, Press release of the French National Academy of Medicine, 9 March 2021.)
[2] Loi n° 2017-1836 du 30 décembre 2017 de financement de la sécurité sociale pour 2018, JORF, 31 déc. 2017. (Law No. 2017-1836 of 30 December 2017 on the financing of social security for 2018, JORF, 31 Dec. 2017.)
[3] Commission EDH, 12 juill. 1978, Association X. Contre Royaume-Uni, n°7154/75. (ECHR Commission, 12 July 1978, Association X. v. United Kingdom, no. 7154/75)
[4] D. Lévy-Bruhl. « Politique vaccinale », in F. Bourdillon (dir.), Traité de santé publique. Lavoisier, 2016, pp. 311-322. (D. Lévy-Bruhl. “Vaccine policy”, in F. Bourdillon (ed.), A treatise on public health. Lavoisier, 2016, pp. 311-322.)
[5] Ph. Sansonetti, « La défiance vis-à-vis des vaccins, un luxe pour ceux qui sont protégés par les autres ? », Après-demain, vol. n° 42, n° 2, 2017, pp. 9-11. (Ph. Sansonetti, Vaccine mistrust, a luxury for those who are protected by others?”, Après-demain, vol. no. 42, no. 2, 2017, pp. 9-11.)
[6] CEDH, 8 avr. 2021, Vavřička c. République tchèque, n°46621/13. (ECHR, 8 Apr. 2021, Vavřička v. Czech Republic, no. 46621/13.)
[7] CC, déc. n° 2015-458 QPC, 20 mars 2015, Époux L. (CC, Dec. no. 2015-458 QPC, 20 March 2015, Époux L.)
[8] Comirnaty. An overview of Comirnaty and why it is authorised in the EU, EMA/215190/2021, p. 4.
[9] Covid-19 Vaccine Moderna. An overview of COVID-19 Vaccine Moderna and why it is authorised in the EU, EMA/704373/2020, p. 4.
[10] COVID-19 Vaccine Janssen. An overview of COVID-19 Vaccine Janssen and why it is authorised in the EU, EMA/229490/2021; Vaxzevria. An overview of Xaxzevria and why it is authorised in the EU, EMA/213411/2021.
[11] Committee for Medicinal Products for Human Use, Covid-19 Vaccine AstraZeneca, Assessment report, EMA/94907, 20 January 2021, p. 176.
[12] Committee for Medicinal Products for Human Use, Covid-19 Vaccine Janssen, Assessment report, EMA/158424, 11 March 2021, p. 209.
[13] Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
[14] Janssen Vaccines & Prevention B.V., Summary Notification Information Format for the Release of Genetically Modified Organisms Other Than Higher Plants in Accordance with Article 11 of Directive 2001/18/EC, Ad26COVS1, 6 July 2020.
[15] Ph. Amiel, « Expérimentation sur l’être humain », in C. Bonah, J.-M. Mouillie et al., Médecine, santé et sciences humaines, Les Belles Lettres, pp. 564-576, 2011. (Ph. Amiel, “Experimentation on human beings”, in C. Bonah, J.-M. Mouillie et al, Medicine, Health and Humanities, Les Belles Lettres, pp. 564-576, 2011.)
[16] G. Chamayou, Les corps vils. Expérimenter sur les êtres humains aux XVIIIe et XIXe siècles, La Découverte, 2014, pp. 341-384. (G. Chamayou, Vile Bodies. Experimenting on human beings in the 18th and 19th centuries, La Découverte, 2014, pp. 341-384.)
[17] W. Beaumont, Experiments and Observations on the Gastric Juice, Plattsburgh, P. P. Allen, 1833, p. 20.
[18] C. Bernard, Introduction à la médecine expérimentale, J. B. Baillère & Fils éd., 1865, II, chap. 2, § 3. (C. Bernard, Introduction to experimental medicine, J. B. Baillère & Fils ed., 1865, II, chap. 2, § 3.)
[19] A. Claudy, Histoire de la dermatologie lyonnaise, Société française d’Histoire de la dermatologie. (A. Claudy, History of dermatology in Lyons, French Society for the History of Dermatology.)
[20] L. Pasteur, Lettre adressée à Pedro II, empereur du Brésil, 22 sept. 1884, Archives Nationales, AB/XIX/3332. (L. Pasteur, Letter to Pedro II, Emperor of Brazil, 22 Sept. 1884, National Archives, AB/XIX/3332.)
[21] Schleswig-Holstein Ministerium für Soziales, Gesundheit, Jugend, Familie und Senioren, Wissenschaftliche Untersuchung der Praxis der Medikamentenversuche in schleswig-holsteinischen Einrichtungen der Behindertenhilfe sowie in den Erwachsenen-, Kinder- und Jugendpsychiatrien in den Jahren 1949 bis 1975, 12 Januar 2021, p. 35. (Schleswig-Holstein Ministry of Social Affairs, Health, Youth, Family and Senior Citizens, Scientific study of the practice of drug trials in Schleswig-Holstein institutions for the disabled and in adult, child and adolescent psychiatric institutions in the years 1949 to 1975, 12 January 2021, p. 35.)
[22] P.-C. Bongrand, L’expérimentation sur l’homme. Sa valeur scientifique et sa légitimité, 1905, Presses de l’Institut Gustave Roussy/IGR Press.fr, 2011, p. 122. (P.-C. Bongrand, Experimentation on humans. Its Scientific Value and Legitimacy, 1905, Gustave Roussy Institute Press/IGR Press.fr, 2011, p. 122.)
[23] Ph. Amiel, Des cobayes et des hommes ; expérimentation sur l’être humain et justice, Les Belles Lettres, 2011. (Ph. Amiel, Guinea pigs and humans: experimentation on human beings and justice, Les Belles Lettres, 2011.)
[24] Cass, 28 janv. 1942, Teyssier, Gaz. Pal. 1942, 1, p. 177 ; B. Hoerni et J.-P. Bouscharain, « Arrêt Teyssier de la Cour de Cassation, 28 janvier 1942 : quelques remarques sur une décision “oubliée” », Histoire des sciences médicales, t. XXXV, n°3, 2001. (Cass, 28 Jan. 1942, Teyssier, Gaz. Pal. 1942, 1, p. 177; B. Hoerni and J.-P. Bouscharain, "Teyssier ruling of the Court of Cassation, 28 January 1942: some remarks on a “forgotten” decision", History of Medical Science, t. XXXV, n°3, 2001.)
[25] R. Working, « The Trial of the Unit 731 », The Japan Times, 5 June 2005.
[26] J. K. Baird, « War Crimes in Japan-Occupied Indonesia: Unraveling the Persecution of Achmad Mochtar », The Asia-Pacific Journal Japan Focus, Jan. 1, 2016, vol. 14, issue 1, n° 4.
[27] J. Graven, « Le procès des médecins nazis et les expériences pseudo-médicales. Esquisse d’une étude de synthèse, Annales de droit international médical, n°8, juin 1962, p. 5. (Graven, "The trial of Nazi doctors and pseudo-medical experiments. Outline of a synthesis study, Annals of International Medical Law, No. 8, June 1962, p. 5.)
[28] Ph. Amiel, « Expérimentations médicales : les médecins nazis devant leurs juges », in F. Vialla, Les grandes décisions du droit médical, LGDJ, 2009, pp. 431-444. (Ph. Amiel, "Medical experiments: Nazi doctors before their judges”, in F. Vialla,
The Great Decisions of Medical Law, LGDJ, 2009, pp. 431-444.)
[29] Ph. Amiel, «Code de Nuremberg” : traductions et adaptations en français», in Des cobayes et des hommes, op. cit. (Ph. Amiel, "Nuremberg Code”: translations and adaptations into French", in Guinea Pigs and Humans, op. cit.)
[30] Ph. Amiel, F. Vialla, « Le “code de Nuremberg”, une jurisprudence pénale inaugurale endroit international de la santé », in E. Cadeau, É. Mondielli, F. Vialla (dir.), Mélanges en l’honneur de Michel Bélanger : modernité du droit de la santé, Les éditions hospitalières, 2015, pp.573-585. (Ph. Amiel, F. Vialla, "‘The Nuremberg Code’, a preliminary criminal jurisprudence in the international health field”, in E. Cadeau, É. Mondielli, F. Vialla (eds.), Selections in honour of Michel Bélanger: The modernity of health law, Les éditions hospitalières, 2015, pp.573-585.)
[31] A. M. Salam, A. S. Carr, « Racing for Covid-19 Vaccine and Cure: Lessons and Tragedies in Human Subject Research », Heart Views, 2020 Jul-Sep, 21(3), p. 229–234.
[32] R. Leung, « America’s Deep, Dark Secret », CBS News, Apr. 29, 2004.
[33] Center for Disease Control and Prevention, The Tuskegee Timeline.
[34] S. Krugman, « The Willowbrook Hepatitis Studies Revisited: Ethical Aspects », Reviews of infectious diseases, vol. 8, n°1, Jan.-Febr. 1986, 157-162.
[35] B. Fintel, A. T. Samaras, E. Carias, « The Thalidomide Tragedy: Lessons for Drug Safety and Regulation », Helix, Jul. 28, 2009.
[36] « Hospital Accused on Cancer Study », The New York Times, Jan. 21, 1964.
[37] CCNE, Avis sur les essais de nouveaux traitements chez l’homme. Réflexions et propositions, n°2, 9 oct. 1984. (CCNE, Opinion on trials of new treatments in humans. Reflections and proposals, No. 2, 9 Oct. 1984.)
[38] Sciences de la vie : de l’éthique au droit, Rapport G. Braibant, La Documentation française, 1988. (Life sciences: from ethics to law, G. Braibant Report, La Documentation française, 1988.)
[39] Loi n°88-1138 du 20 déc. 1988 relative à la protection des personnes qui se prêtent à des recherches biomédicales, JORF, 22 déc. 1988. (Law No. 88-1138 of 20 Dec. 1988 on the protection of persons who undergo biomedical research, JORF, 22 Dec. 1988.)
[40] Loi n° 2012-300 du 5 mars 2012 relative aux recherches impliquant la personne humaine, JORF, 6 mars 2012. Voir : J. Ducruet, « Protection des personnes qui se prêtent à des recherches biomédicales », Laennec, vol. 56, n°3, 2008, pp. 6-24. (Law No. 2012-300 of 5 March 2012 on research involving the human person, JORF, 6 March 2012. See: J. Ducruet, "Protection of persons undergoing biomedical research”, Laennec, vol. 56, No. 3, 2008, pp. 6-24.)
[41] CEDH, 29 avr. 2002, Pretty c. Royaume-Uni, n°2346/02. (ECHR, 29 Apr. 2002, Pretty v. UK, no. 2346/02.)
[42] CEDH, 9 juill. 2002, Salvetti C. Italie, n°42197/98. (ECHR, 9 July 2002, Salvetti v. Italy, No. 42197/98.)
[43] Jean, 20, 17.
[44] CC, déc. n° 94-343/344 DC, 27 juillet 1994, Loi relative au respect du corps humain et loi relative au don et à l’utilisation des éléments et produits du corps humain, à l’assistance médicale à la procréation et au diagnostic prénatal, JORF, 29 juill. 1994, p. 11024. (CC, Dec. No. 94-343/344 DC, 27 July 1994, Law on the respect of the human body and law on the donation and use of elements and products of the human body, on medically assisted procreation and on prenatal diagnosis, JORF, 29 July 1994, p. 11024.)
[45] CAA Paris, 8ème ch., 4 août 2017, 16PA00157 et 16PA03634. (CAA Paris, 8th ch., 4 August 2017, 16PA00157 and 16PA03634.)
[46] M. Horkheimer, Éclipse de la raison, 1947, Payot, 1974. (M. Horkheimer, The eclipse of Reason, 1947, Payot, 1974.)
[47] Th. W. Adorno, Minima Moralia. Réflexions sur la vie mutilée, 1951, Payot, 2016.
[48] K. Abbasi, “Covid-19: politicisation, ‘corruption’, and suppression of science”, The British Medical Journal, 2020, 371. Online:
www.bmj.com/content/371/bmj.m4425 (accessed 7 May 2021).
[49] L’Obs, 15 janv. 2016. Voir aussi Y. Bardie, Essai clinique : du patient à l’objet de science, Éd. Sauramps Médical, 2013. (L'Obs, 15 Jan. 2016. See also Y. Bardie, Clinical trial: from patient to science object, Editions Sauramps Médical, 2013.)
