A French journal, Revue Des Droits et Libertés Fondamentaux, has published a preliminary legal judgement on mandatory vaccines. In summary, it argues that French law technically bans the Covid vaccines without informed consent because they are experimental. We think this is of public interest and of relevance to the UK, where millions have been vaccinated without informed consent, and therefore have translated it to the best of our abilities.
FOUR anti-Covid vaccines are currently authorised in France: the Moderna, the Pfizer & BioNTech (brand name), the AstraZeneca (brand name Vaxzevria) and the Johnson & Johnson (brand name Janssen).
Vaccination is the answer primarily chosen by the French authorities in response to the pandemic. Faced with resistance from part of the population, the question of whether it should not be made compulsory for caregivers, or even for all French people, has entered the public debate.
In general, the vaccination obligation finds its basis in several international and national texts. The International Covenant on Economic, Social and Cultural Rights of December 16, 1966, provides that in order to guarantee the right to individual health, States must take the necessary measures to ensure ‘the prophylaxis and treatment of epidemic diseases’.
In France, the minister responsible for health draws up the vaccination policy and the law that determines which vaccines are compulsory. Eleven of them are for children. Health professionals and embalming workers are also subject to certain vaccination obligations, as are travellers who wish to visit Guyana.
It is, moreover, admitted that ‘when a small number of deaths occur within the framework 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 November 4, 1950.
Vaccination has enabled the eradication of smallpox, a 99 per cent reduction in polio cases between 1988 and 2016, a considerable reduction in cases of tetanus, measles and diphtheria, whooping cough, etc.
Conversely, the resurgence of certain lethal infectious diseases is linked to the reduction in vaccination coverage, which may justify making vaccines compulsory.
In a recent case, the European Court of Human Rights appeared to give pledges to States wishing to impose this obligation in the fight against Covid-19.
In the Vavřička judgment of April 8, 2021, it considered that while compulsory vaccination of children was an interference with privacy, it was necessary in a democratic society in the name of social solidarity.
This judgment, together with the fact that the French government had intervened in the proceedings, was interpreted as an additional argument in favour of the obligation. This was especially so since the Constitutional Council had already refused in 2015 to declare contrary to the constitution the obligation of childhood vaccination against polio, diphtheria and tetanus.
The health crisis resulting from 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, obscure that of the medical means used to stop it, namely the novel nature of the vaccine procedures used.
Thus, the marketing authorisation given to manufacturers under the accelerated procedure by the European Medicines Agency (EMA) is conditional. According to the EMA, this type of authorisation is issued ‘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 (EPAR) submitted within the European Medicines Agency for Pfizer and Moderna indicate that pharmaceutical companies have yet to ‘provide the results of the main trial, which continues for two years’.
The marketing authorisation was granted to Pfizer on December 21, 2020 until December 2022. The ‘final report of the clinical study’ will be submitted in December 2023.
For Moderna, the authorisation was given on January 6, 2021 until January 2023. The ‘final report of the clinical study’ will be submitted in December 2022. The fact that this is a vaccination in the experimental phase can therefore not be in doubt.
For the other two vaccines, the marketing authorisation is also conditional. The AstraZeneca vaccine was authorised on January 29, 2021 and the Johnson & Johnson vaccine on March 11, 2021. Companies that market them will have to continue to ‘provide the results of clinical trials, which are ongoing’.
For AstraZeneca, the ‘final clinical study reports’ are expected on May 31, 2022. Those for the Johnson & Johnson vaccine are expected on December 31, 2023.
The ‘clinical trial’ formula used by the European Agency is unequivocal. This concept is defined by Directive 2001/20 / EC of the European Parliament and of the Council of April 4, 2001.
According to this text, a clinical trial is an ‘investigation carried out in humans, in order to determine or confirm the clinical, pharmacological and / or other pharmacodynamic effects of one or more experimental drugs … with the aim of ensuring their safety and / or efficacy’.
It should be noted, for example, that, apart from the uncertainties relating to their specific technique – mRNA or recombinant DNA – ‘no carcinogenicity study has been carried out’ for the Moderna vaccine and ‘no genotoxicity study or carcinogenicity has been achieved’ for the Pfizer, AstraZeneca and Johnson & Johnson vaccines.
All of this information is sufficient to convince that the Covid-19 pandemic has led health authorities to authorise a large-scale vaccine experiment unprecedented in the history of medicine.
In times of emergency, nothing seems legally to oppose it, both in terms of individual health in order to protect vulnerable people and in terms of public health to avoid the saturation of hospital structures.
On the other hand, the experimental nature of vaccination invites the jurist to recontextualise its use, because in this matter, both domestic law and international law have historically constructed the notion of the subject’s consent as a safeguard to prevent any drift.
Therefore, this principle of consent seems sufficiently well established to constitute an obstacle to compulsory vaccination as long as the clinical trial phases have not been completed.
In 1796, Doctor Edward Jenner inoculated an eight-year-old boy with pus taken from a dairymaid suffering from cowpox. The child developed mild fever, but when he was later injected with smallpox matter, it was found he was immune.
Faith in progress and the exaltation of scientific discoveries then incited experiments on ‘vile bodies’ considered of little value – prisoners, internees, slaves, natives, prostitutes.
In the 18th century, doctors carried out experiments on black slaves in the European colonies of the West Indies and North America. Preventive inoculation of diseases such as smallpox was used on entire populations to attempt immunisation in the context of mass experimentation
In the 19th century, experiences multiplied. Some doctors showed a high ethical conscience. This is the case, in 1833, of an American military surgeon, William Beaumont, who carried out experiments on a patient suffering from a fistula in the stomach, but only after having sought his agreement and having committed him to this end.
In 1856, Claude Bernard, in laying down the principles of the experimental method, recommended ‘never to practise on a man an experiment which could only be harmful to him to any degree’.
However on December 15, 1859, the criminal court of Lyon condemned for wilful injury two hospital doctors who voluntarily inoculated syphilis into a ten-year-old boy who came to consult for a ringworm. In 1884, Louis Pasteur himself wrote to the Emperor of Brazil asking for permission to infect Death Row inmates with cholera in order to try treatments on them.
The requirements of experimentation are therefore far from being immediately synonymous with ethics. In 1892 in Germany, a physician director of a clinic was convicted of having injected syphilis into prostitutes and minors without their knowledge.
Following this affair, the German health services adopted on December 29, 1900 an instruction to the directors of clinics, polyclinics and hospitals which imposed on them in terms of experimentation ‘the clear consent’ of the person concerned.
A French doctor, Pierre-Charles Bongrand, was the first to express the modern idea according to which the human subject – and not the doctor – is at the centre of the experimental device.
In 1905, in his thesis for the doctorate in medicine, he observed that, while being indispensable to medical progress, experiments on human beings were immoral, because they sacrificed the individual for the community.
This is why he proposed to establish an agreement between the experimenter and the subject based on ‘prior consent’. But the concept did not immediately translate into law and was first legally enshrined by a decree of the French Supreme Court on 28 January 1942, stating that all doctors have a fundamental obligation towards the State to obtain their patients’ consent.
As for medical research, it continued to be assumed that it was humanist simply because it aimed to improve the lot of the community. ‘The labour of men of genius, even when directed in the wrong direction, almost always ends up working to the full advantage of mankind,’ wrote Mary Shelley in Frankenstein in 1818.
The 20th century has, however, largely denied the presupposition of the humanist aims of all medical research. Thus Unit 731, created by Imperial Japan in 1932, killed more than 10,000 prisoners used as human guinea pigs in the laboratory.
In August 1944, the Chief Medical Officer of the Japanese Army, Nakamura Hirosato, caused the death of 900 Indonesians after ordering the experimental injection of a vaccine containing chemically modified tetanus toxin.
In Germany, neither the Hippocratic Oath, nor government directives in 1931 saying experimentation was prohibited ‘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 the camps of Auschwitz, Buchenwald, Dachau and Natzwzeiler, Nazi doctors used human guinea pigs inoculated with pathogens such as typhus, yellow fever, smallpox, typhoid, cholera and diphtheria to search for vaccines or to develop treatments for immunity.
In the aftermath of the Second World War, 20 doctors and three Nazi officials were accused of war crimes and crimes against humanity and tried in Nuremberg.
The subsequent judgment of the American Military Tribunal of 19 and 20 August 1947 on the crimes of the accused established a list of ten criteria known today as the Nuremberg Code. Among them is the principle of informed consent of the subject.
The defendants claimed that in times of war, the Hippocratic Oath no longer held and that the State could decide to make the interests of science take precedence over that of the individual for the benefit of the nation.
In response, the Nuremberg judges defined principles which should not depend on a determined legal consecration – that is, on the law of a particular State – but on universal medical ethics and even on international law.
This is why the International Covenant on Civil and Political Rights, adopted by the General Assembly of the United Nations on December 16, 1966, in turn provides that ‘it is forbidden to subject a person without their free consent to an experiment medical or scientific’.
The crimes of the Nazi doctors led some to believe that it was just a monstrous accident of history. However, throughout the 20th century, other tragedies resulted from medical experiments without the agreement of the subjects.
Incidents in the US are instructive: The feeding of retarded children with radioactive cereals by researchers at Fernald State School, Massachusetts, in the 1940s and 1950s; false treatments administered to blacks with syphilis by the Tuskegee, Alabama, Public Health Department from 1932 to 1972; contamination of mentally handicapped children with hepatitis by two university doctors at Willowbrook State School in New York from 1956 to 1972.
Then there was the trial on 20,000 Americans of thalidomide, which was given on prescription by general practitioners in the late 1950s until 1961, and the injection of cancer cells into elderly and destitute patients at the Jewish Chronic Disease Hospital in Brooklyn in 1963.
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, adopted the Declaration of Helsinki in June 1964.
It is the first post-Nuremberg international text which returns to questions of ethics in experimentation. It affirms that ‘the participation of capable persons in medical research must be a voluntary act’.
In France, the principles of the Nuremberg Code largely inspire the guarantees provided by law. They were taken up by the National Consultative Ethics Committee in an opinion delivered in 1984 and by the Council of State’s report on life sciences, ethics and law in 1988.
However, it was the law of December 20, 1988, known as the Huriet-Sérusclat law, which for the first time provided for specific permission for medical tests on healthy volunteers – until then prohibited – while recalling the need of ‘free, informed and express consent’.
”  . Medical research, including when it has a therapeutic purpose, is currently governed by the law of March 5, 2012, known as the Jardé law.
According to the Public Health Code, no intervention research can be carried out on someone ‘without their free and informed consent obtained in writing, after having been given the information provided’.
Interventional research is that which ‘includes an intervention on the person not justified by his usual care’ – that is to say, an intervention not without risk for those who participate in it. This includes research on drugs, but also cell therapy or gene therapy as recalled by INSERM, the French public health research organisation.
Both by their nature and by their experimental methodology, the four anti-Covid vaccines appear to fall into this category. As for prior information, it must include in particular ‘foreseeable risks’ and ‘possible medical alternatives’.
This intervention research requires a favourable opinion from a regional body, the Committee for the Protection of Persons (CPP), which depends on the Regional Health Agency (ARS), followed by authorisation by the National Security Agency of the Medicines and health products (ANSM).
In principle, failure to obtain this consent is punishable by three years in prison and a fine of 45,000 euros under the Penal Code. Nevertheless, the rollout of the anti-Covid vaccine led to French health authorities relinquishing the issue to the European Medicines Agency on the basis of Regulation (EC) n ° 726/2004 of March 31, 2004.
With regard to concerns about ‘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 medicines must receive an authorisation from the European Medicines Agency valid for all EU member states.
This relinquishment then precludes a possible action before a French judge for non-compliance with the opinion and authorisation procedure in domestic law, since under the pressure of the circumstances, this has been replaced by a European procedure. On the other hand, it does not in any way dispense with the obligation to obtain the consent of the persons.
Within the Council of Europe, Recommendation No.R (90) 3 of the Committee of Ministers on medical research on human beings, adopted on February 6, 1990, sets out a number of principles.
According to the third, ‘no medical research can be carried out without the informed, free, express and specific consent of the person who lends itself to it’ and, according to the 13th, ‘persons likely to be the subject of medical research must not be induced to submit to it in a way that compromises their free consent’.
This text, if it represents a political and ethical commitment, has no binding legal value. On the other hand, the regulation (EC) of March 31, 2004 provides in a binding way within the European Union the respect of certain ethical requirements during the conduct of clinical trials of medicinal products authorised at European level (Point 16).
Directive 2001/20 / EC of April 4, 2001, explicitly refers to the Declaration of Helsinki and also provides for informed consent (art. 3). Finally, the European Court of Human Rights had the opportunity to rule in 2002 that the imposition of treatment without the patient’s consent is ‘an attack on the physical integrity of the person concerned’ and that ‘compulsory vaccinations as involuntary medical treatments constitute an interference with the right to respect for private life’.
One question remains: Does this principle apply when the experiment consists of a vaccine? The answer is yes, because the directive of April 4, 2001, covers medicinal products as they are defined by another text, Directive 65/65 / EEC of January 26, 1965.
According to this directive, a medicinal product is ‘any substance or composition presented as having curative or preventive properties with regard to human or animal diseases.
‘Any substance or composition which can be administered to humans or animals with a view to establishing a medical diagnosis or to restoring, correcting or modifying organic functions in humans or animals is also considered to be medicinal.’
Anti-Covid vaccines undoubtedly meet this definition. Insofar 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 French law as well as in European Union law.
.While the Vavřička judgment by the European Court does not preclude the anti-Covid vaccination obligation, it does not make it plausible or legally acceptable.
In that case, it was about vaccines long tested, which only arouse marginal disputes among radical opponents of any vaccination.
It is quite different with anti-Covid vaccines. As these are, by the European Medicines Agency’s own admission, in the clinical trial phase, it seems difficult to impose them given the existing legal guarantees.
An obligation to vaccinate in a context of experimentation would run the risk of encountering the sanction of 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 (‘do not touch me’), taken from the words of the risen Christ to Mary Magdalene and reflecting the sacred character of the body.
If this principle of inviolability has not received constitutional consecration, it nevertheless crosses our entire legal system and is covered by the ‘safeguard of the dignity of the person’, a broader concept that the Constitutional Council has elevated to the rank of principle.
It is common to say that medical experimentation benefits the entire human species, although it may be exercised to the possible detriment of those who expose themselves to its risks. In other words, the benefit expected by the greatest number would be well worth the danger incurred by a few.
However, medical experimentation on human beings cannot be reduced to an equation which would make it as obvious as a benefit / disadvantage calculation. Indeed, such reasoning postulates its disinterested purpose while avoiding its economic, political and social determinants.
In the Vavřička case, Judge Wojtyczek observed in a dissenting opinion ‘that no evidence has been submitted to the court to show that the States which have implemented the vaccination obligation obtain better results in terms of public health than the States which have not introduced this obligation’. The remark is crucial and fraught with implications.
We must in fact beware of an idealised vision of scientific rationality which would lead to disregarding the issues of power, financial interests and the institutional strategies which condition it.
Medical research has its own logic of deployment, which is not necessarily humanist and which can be subject to the quest for profit, as the French court case over the weight-loss drug Mediator recently recalled.
It is a fact, moreover, that pure rationality escapes all moral norms and threatens to turn against itself, as the German philosopher and sociologist Max Horkheimer has shown. A marker of civilisation can then be transformed into ‘regressive progress’, according to Theodor Adorno’s theory of the effects of capitalism https://iep.utm.edu/adorno/ on individuals.
If the idea of scientific neutrality is an illusion, the mere use of the term ‘ethics’ in legal texts is not enough to guarantee its harmlessness.
Even when research is strictly framed by law, the principle of free consent often seems fragile in the asymmetrical relationship between medical authority and the subject. It is difficult to see, moreover, how consent could be completely ‘informed’ in the presence of an unknown risk and a complex vaccination technique.
As clinical researcher Yannick Bardie said in 2016, a clinical trial is by nature ‘a very dangerous and unethical exercise’. Given the many uncertainties that will weigh until the end of the trials on anti-Covid vaccines, if it is legitimate to leave volunteers – in particular, vulnerable people – the possibility of receiving the vaccines in full knowledge of the facts, it would appear contrary to the law in force and to the principles on which our liberal system is based to want to impose them on all citizens.