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Vaccination Obligation from the Perspective of the European Court of Human Rights — Taking the Case of Varif et al.v. Czech Republic as an Example
April 19,2023   By:CSHRS
Vaccination Obligation from the Perspective of the European Court of Human Rights
 
Taking the Case of Varif et al.v. Czech Republic as an Example
 
CHEN Yunliang* & MO Tingting**
 
Abstract: The case of Varif et al.v. Czech Republic concerned whether Czech legislation that imposed a moratorium on school attendance and a fine as a punitive mechanism for non-vaccination violates the European Convention on Human Rights by forcing children to receive routine vaccinations. In the ruling, the European Court of Human Rights reiterated that the choice of public health measures falls within the discretion of member states. Meanwhile, to limit the infringement of individual interests to what is necessary and reasonable, the European Court of Human Rights clarified the criteria for human rights protection for compulsory routine vaccination: It should have a legal basis, a lawful aim, and be in line with the “needs of a democratic society.” Accordingly, the European Court of Human Rights held that the legal provisions involved in the case did not violate the European Convention on Human Rights. As the first response of the European Court of Human Rights to compulsory vaccination, the case of Varif et al.v. Czech Republic strengthens the influence of the law of the European Union in the field of public health by upholding the discretion of member states. Besides, although the case involves only routine vaccination, the human rights protection criteria clarified in it can be taken as a reference for introducing vaccination measures against COVID-19 in the context of the global pandemic.
 
Keywords: obligation to vaccination · compulsory · European Court of Human Rights
 
Vaccination is one of the most prevalent measures of disease prevention. Some European countries have a tradition of legislating on the obligation to vaccination, such as the promulgation of the Public Health Protection Law in France in 1902, which mandated vaccination against smallpox.1 However, there is no consensus in all the member states of the European Unioon the need for mandatory vaccination to reduce the occurrence and spread of diseases. According to statistics, as of 2019, only 18 of the EU’s 28 member states had statutory obligations to vaccination or relevant legislative programmes.2 Disagreement about the need for vaccination measures is between governments and among some European citizens, who have even filed lawsuits against such legislation and reviewed its constitutionality all the way to the European Court of Human Rights (hereinafter referred to as the Court of Human Rights). The sudden outbreak of COVID-19 has further pushed the Court of Human Rights to decide whether compulsory vaccination measures violate the European Convention on Human Rights (hereinafter referred to as the Convention), and to refine the European standards for human rights protection in the practice of compulsory vaccination.
 
The Case of Varif et al.v. Czech Republic,3 which was concluded in April 2021, was the first case to be heard by the Court of Human Rights involving compulsory vaccination measures for children. In this case, the Court of Human Rights held that although the Czech Government’s regulation on the compulsory routine vaccination of children constitutes a restriction of fundamental human rights, the regulation still stands as being necessary and reasonable, does not exceed the scope of the free judgment of the member states, and does not violate the Convention.4 The decision of the Court of Human Rights is binding on both parties involved, according to Article 46 of the Convention, that is, “the member states undertake to comply with the decision of the Court.” This means that when the Court of Human Rights considers that a member state has violated the Convention, the latter has a consequential obligation to take measures to bring the litigation-related matters into conformity with the Convention. In contrast, when the Court of Human Rights holds that a member state does not violate the Convention, the verdict has only a declaratory nature (caractère déclaratoire).5 For instance, the verdict in the Case of Varif et al.v. Czech Republic states only that there has been no breach of the Convention in litigation-related matters. But the practical influence of the ruling is beyond this point. It “helps to clarify, safeguard and develop the rules stipulated in the Convention, and thus helps states to comply with the commitments they have made as parties” to the Convention.6 Therefore, this paper aims to analyze the legal issues related to the Case of Varif et al.v. Czech Republic and its social impact. Before that, it should be noted that the “mandatory vaccination” referred to in this paper refers to the health administrative behavior that stimulates the willingness to vaccinate by restricting the freedom of choice of those who do not fulfill the obligation to vaccination. Mandatory vaccination does not mean violent means of vaccination, but linking the obligation to vaccination to “life events” such as school admission and entry into employment. When the obligor fails to fulfill or incompletely fulfills the obligation to vaccination, the exercise of the relevant option is limited and targeted, and even supplemented with an appropriate fine to promote the fulfillment of the vaccination obligation.
 
I. Basic Facts of the Case and Its Domestic Litigation Process
 
A. The domestic law background of the case
 
In 2000, the Czech Parliament passed Law No. 258/2000, which made it obligatory for residents and foreigners with long-term residency to get the legally prescribed vaccine, and for guardians of minors under the age of 14 to ensure that this obligation was fulfilled. The above provisions were subsequently incorporated into the country’s Public Health Protection Act as Article 46. The article also stipulates that the government will issue administrative regulations and decrees to specify mandatory vaccination measures.7 From 2000 to 2006, the Czech Government successively issued decrees to clarify major issues of mandatory vaccination, such as types and timing.8 Regarding the legal liability for non-performance of the obligation to vaccination, on the one hand, Article 50 of the country’s Public Health Protection Act specifies that a child who has not completed vaccination may not attend any preschool institution unless the child has a medical certificate showing that he/she has received other immunization measures or is unfit for vaccination. A similar provision is made in Article 34, paragraph 5 of the Czech Education Act.9 On the other hand, Article 29 (1) of the country’s Act on Misdemeanors stipulates that violation of the prohibition on the prevention of infectious diseases or failure to perform an obligation for the purpose of the prevention of infectious diseases constitutes a misdemeanor punishable by a fine of up to CZK 10,000 (approximately EUR 400).10 Besides, Czech law makes it clear that the cost of getting the annual mandatory vaccine set by the government is covered by the public health insurance agency. The government provides treatment, also at the agency’s expense, for individuals who suffer side effects from such vaccines. From August 2020, the state assumes objective liability for health damage caused by mandatory vaccination without exemption reasons.11 In the process of establishing and implementing mandatory vaccination measures in the Czech Republic, some citizens of the country believed that the relevant mandatory measures violated fundamental human rights, so they filed administrative lawsuits and a constitutional review. The Czech Supreme Administrative Court and the Constitutional Court took this opportunity to respond to major issues such as “whether mandatory vaccination violates human rights” and “whether it is necessary and reasonable”.
 
B. Review by the Constitutional Court of the Czech Republic: exemption from the obligation to vaccination
 
In 2003, the Czech Center for Disease Prevention and Control fined Mr. Varif, a Czech citizen, about EUR 110 for failing to get a legally required vaccine for his children. Varif refused to accept the penalty decision and filed an administrative review and related lawsuits. Varif argued that the decision to fine violates fundamental human rights, in particular, the right to informed consent under Article 5 of the Oviedo Convention and the rights of subjects lacking the capacity to consent under Article 6 of the Oviedo Convention. Varif was adamant that vaccination could have side effects. Meanwhile, he questioned the need for mandatory vaccination, noting that the last outbreak of polio was in the 1960s, hepatitis B only affected high-risk groups, and tetanus was not even contagious.12
 
In 2006, the Czech Supreme Administrative Court upheld Varif’s view. However, this decision was subsequently overturned by the Constitutional Court of the Czech Republic, for the Supreme Administrative Court did not adequately respond to the plaintiffs’ argument that “the administrative decision related to litigation violated their right to free expression of religion or belief.13 Meanwhile, the Constitutional Court held that the obligation to vaccination did not pose a great threat to the fundamental human rights of the plaintiffs. The main reasons are as follows: 
 
The Constitutional Court of the Czech Republic believed that, in a democratic society, mandatory vaccination is necessary for the sake of public health and the health, rights and freedoms of others. Although the measure restricts the right of individuals to express their religion or belief freely, the restriction is acceptable. The Constitutional Court emphasized that, to be consistent with constitutional requirements, this restriction cannot be imposed indiscriminately on everyone without considering the reasons for the individual’s refusal to be vaccinated.14 The Constitutional Court required authorities to take into account individuals’ stated reasons for refusing vaccination in advance when urging them to do so and when imposing penalties on those who fail to do so. Where the reason for refusing vaccination relates to the fundamental preservation of individual autonomy, the government may not impose an obligation to vaccination on individuals, impose penalties or enforce that obligation in other ways. In particular, the government needs to consider the urgency of the reasons for the vaccination refusal, the constitutional dimension, the social harm of stakeholders’ actions, and the credibility and consistency of stakeholders’ claims to refuse vaccination. The urgency and consistency of the claims do not hold if the person who refuses the vaccination did not state the reasons for the refusal from the beginning. The Constitutional Court questioned the consistency of the reasons for Varif’s refusal to be vaccinated. In particular, Varif argued that his refusal to vaccinate his children was based on religious beliefs only after the administrative proceedings had begun. Accordingly, the Constitutional Court remanded the case to the Supreme Administrative Court for rehearing.15
 
In the process of retrial, the Supreme Administrative Court rejected the plaintiffs’ appeal according to the judgment of the Constitutional Court. The Supreme Administrative Court pointed out that the mandatory vaccination measure gives plaintiffs and their children the right to refuse vaccination. But the plaintiff did not promptly state the reasons for refusing the vaccination, nor did he provide sufficient evidence that his right to free expression of religion or belief was violated by the measure. Thus, the Supreme Administrative Court held that the guarantee of public health was superior to the protection of individual freedom of expression of religion or belief. In 2013, the Constitutional Court of the Czech Republic made a final ruling on the case, supporting the previous judgment of the Supreme Administrative Court.16
 
C. The domestic impact of the case: affirmation and development
 
The Constitutional Court of the Czech Republic clarified the criteria for the constitutionality of mandatory vaccination measures through the Varif Case, that is, to set possible exemptions for the obligation to vaccination.
 
But the conflict and controversy caused by such measures has not come to an abrupt end. After the Varif Case, the country’s Constitutional Court successively tried the Novotná Case, Hornycg Case, the “Case of of Bro?ík and Dubsky, the Case of Role?ek and other cases related to mandatory vaccination. (The parties to the above cases later filed lawsuits with the Court of Human Rights, and the series of cases was combined with the Varif Case). The verdict in the Varif Case has been affirmed and reaffirmed repeatedly in subsequent trials. Meanwhile, the subsequent ongoing cases also prompted the Czech Supreme Administrative Court and the Constitutional Court to further improve and refine the verdict of Varif Case.
 
This is mainly reflected in the Constitutional Court’s decision IUS1253/14. The Constitutional Court noted that a secular reason for refusing vaccination should meet four conditions :(1) It has a constitutional dimension; (2) it embodies urgency; (3) it is persuasive and consistent; (4) it has acceptable social influence. The Court further clarified what each condition has “a constitutional dimension” that means that the reason for refusing vaccination represents a conflict between different rights protected by the Constitution. “Urgency” means “Here and Now”. The Constitutional Court held that many circumstances reflect the urgency and cannot be generalized. The most typical case is that vaccination will cause irreversible damage to the health of the vaccinated person or his/her close relatives. The persuasiveness and consistency of the reasons for refusing vaccination must be analyzed by taking into account the social environment, the personal situation of the vaccinated person and his/her close relatives and other factors. The Varif Case has made it clear that those who refuse vaccination should not hesitate to communicate the reasons for their refusal with the competent authorities. Finally, “acceptable social influence” requires that approving the reasons for refusing vaccination does not lead to consequences incompatible with the lawful aim of public health law, especially low vaccination rates. When the reasons for refusing vaccination meet all four of the above conditions, the government can no longer require individuals to fulfill their obligations to vaccination, including charging no fines and taking other immunization measures. In terms of the validity of the reasons for refusing vaccination based on religious belief, the Constitutional Court clearly pointed out that secular reasons should not be treated differently from religious ones. A refusal to vaccinate on religious grounds is not necessarily unsupported by the Constitutional Court. But courts must judge on a case-by-case basis and cannot arbitrarily extend an individual to a religious group. The Constitutional Court concluded that “the statutory obligation to vaccination can only be exempted in a few exceptional cases that are closely related to the obligor and his/her close family members, for example, if the obligor or his/her children have suffered a serious adverse reaction to vaccination”17.
 
II. The Verdict of the Court of Human Rights
 
After the Constitutional Court of the Czech Republic recognized the constitutionality of the obligation to vaccination, Czech residents, including Varif and Novotna, who were punished for failing to comply with this obligation, considered that legislating an obligation to vaccination violates the provisions of Articles 8 (right to respect in private life), 9 (right to freedom of thought, belief and religion) of the Convention, and Article 2 (right to education) of Protocol I to the Convention,18 which constituted a violation of fundamental human rights. Six complainants took the Czech Government to the Court of Human Rights successively between 2013 and 2015. The First Chamber of the Court of Human Rights accepted these cases and then consolidated them. In 2019, the First Chamber considered that the case involved major issues affecting the interpretation of the Convention and its Protocol, and referred the case to the Grand Chamber. The Grand Chamber consists of the President and Vice President of the Court of Human Rights, the President of the Chamber, and judges from 14 member states. France, Germany, Poland and Slovakia participated in the written hearing of the case as observers and put forward observations. Besides, the Grand Chamber also heard the observations of four private independent organizations, including the Association of Vaccine Injured Patients.19 After extensive discussion with multi-party participation, on April 8, 2021, the Grand Chamber ruled 16 to 1 that the obligation to vaccination specified in Czech law does not violate the Convention.20 In this case, the review steps of the Court of Human Rights are as follows: the first step was to clarify the dispute focus of the case, that is, which article of the Convention the claim at issue belonged to. The second step was to determine whether the legal provisions involved in litigation violate the provisions of this article, that is, to refine the human rights protection standards for the implementation of mandatory vaccination. In this case, the Court of Human Rights proposed that, as a restriction on human rights, whether the mandatory vaccination measures conform to the Convention should be judged from three aspects: the first is whether the restriction is in accordance with the law. The second is whether it has a legitimate aim. The last is whether it is a necessity in a democratic society.
 
A. Sorting out the dispute focus of the case
 
Six plaintiffs complained to the Court of Human Rights on the basis of Articles 8 and 9 of the Convention and Article 2 of Protocol I of the Convention, but the Court found that only the complaint based on Article 8 of the Convention was admissible.21
 
With regard to Article 9 of the Convention, the Court of Human Rights shared the views of the Czech Government and the third-party observer, the European Center for Law and Justice: The plaintiffs’ refusal to vaccinate was not based on religious grounds, but on freedom of thought and belief. However, the right to freedom of thought and belief does not mean that individuals have absolute freedom to act in the way their beliefs point to. The personal beliefs on which the plaintiff based his decision to refuse vaccination do not possess the degree of rigor and importance required by the Court of Human Rights in its precedent. The Court does not accept claims based on Article 9 of the Convention.22 With regard to Article 2 of Protocol I of the Convention, the Czech Government considers that this article does not apply to preschool education. The Court of Human Rights decided that the key issue in the case was whether the obligation to vaccination as an interference into a person’s private life violated the Convention. Therefore, it is not necessary to consider separately whether the measure violates the right to education under Article 2 of Protocol I to the Convention.23 The judge dissenting from the decision in the Case of Varif et al.v. Czech Republic faulted the Court of Human Rights for not carefully considering the above provisions. It should be noted that the judge did not hold that the measure being argued violated Article 8 of the Convention.24 It can be seen that, in fact, the Court of Human Rights has formed a unanimous opinion that mandatory vaccination measures do not violate Article 8 of the Convention.
 
On the basis of the admissible nature of complaints under Article 8 of the Convention, the Court of Human Rights reaffirmed the obligation of member states to respect, protect and fulfill the right of individuals to private life. Among them, the obligation of respect mainly means that the state shall not interfere with matters within the scope of the right to private life. As for the scope of the right to private life, the Court of Human Rights holds that it at least includes the right to personal physical and mental integrity, the right to establish and develop relationships with peers, the right to personal physical and social identity, the right to personal development and the right to make independent decisions.25 However, the right to respect to a person’s private life is not absolute. Article 8 (2) of the Convention makes it clear that in a democratic society, necessary intervention is permitted in accordance with the law in the interests of national security, public safety or national economic welfare, to prevent disorder and crime, to protect health or morality, and to protect the rights and freedoms of others. Accordingly, the Court of Human Rights held that, as an involuntary medical intervention, the obligation to vaccination undoubtedly constitutes an interference with the right to respect for private life within the meaning of Article 8 of the Convention. The case hinged on whether the interference was justified.26 In particular, can the exceptional circumstances of Article 8 (2) of the Convention be satisfied?27 Focusing on the key issue, the Court of Human Rights listened to a wide range of views and clarified the criteria for justifying the interference of the obligation to vaccination with fundamental human rights.
 
B. Human rights protection standards for mandatory vaccination
 
The Court of Human Rights made it clear in the Case of Varif et al.v. Czech Republic that, to judge whether an involuntary medical intervention such as mandatory vaccination conforms to the requirements of the Convention, we should mainly examine whether the implementation of the measure has a legal basis, lawful aim, and is “necessary for a democratic society”. Among them, the last point is more complicated and needs further analysis from the following three aspects: First, whether the measure “responds to the urgent needs of society”; Second, whether the implementation reasons are appropriate and sufficient; finally, whether it meets the requirements of the principle of proportionality.
 
1. Legal basis and lawful aim
 
In terms of the legal basis for the obligation to vaccination, recognizing that the obligation constitutes an interference with an individual’s right to private life, the Court of Human Rights emphasized that all interference with the rights guaranteed by the Convention must be based on the domestic law of the member state. The “law” referred to here should be understood from the level of substance, not only in the formal sense of law. In this sense, “written law” includes existing law and its interpretation by competent judicial institutions.28 The Court of Human Rights requires that the domestic legal basis of a member state be readily available and detailed enough to provide guidance for people to judge the consequences of an act based on specific circumstances and legal provisions.29 In this case, the Court of Human Rights recognized that the legal basis of mandatory vaccination measures in the Czech Republic is the provisions of the Public Health Protection Act, the Act on Misdemeanors, the Education Act, and related decrees. The above laws and provisions are clear enough to provide guidance for people’s behavior, and their constitutionality has been demonstrated by the Constitutional Court of the country. The fact that after the enactment of the aforementioned law, the Czech Government issued a decree to improve the mandatory vaccination system does not affect the legal basis of the system.30
 
As far as the lawful aim of the obligation to vaccination is concerned, the Czech Government states that the purpose of specifying the obligation in legislation is to protect public health and the rights and freedoms of members of society,31 that is, to protect members of society from diseases that may have a significant impact on health. The beneficiaries of mandatory vaccination measures include vaccinated people and individuals who cannot be vaccinated but are protected by the effect of “herd immunity.” The Court of Human Rights endorsed the aforementioned view of the Czech Government, holding that the purpose of clarifying the obligation to vaccination is consistent with Article 8 of the Convention.32
 
2. Necessary for a democratic society
 
Through the Case of Dubska and Krejzov v. The Czech Republic33 and Case of Fernandez. Martinezt. Spain,34 the Court of Human Rights specified that the interference of public power in human rights is “necessary for a democratic society” when the following conditions are met: It answers a pressing social need; the reasons are relevant and sufficient; and it is proportionate to the legitimate aim pursued.35 The above ideas are restated in the Case of Varif et al.v. Czech Republic.
 
Before making a specific judgment, the Court of Human Rights emphasized that judgment follows the principle of “leeway for free judgment.” The Court noted that member state governments have the responsibility to provide human rights protection to their populations and to be more aware of local conditions and needs, and have the right to make a preliminary judgment on the need for intervention measures. In making these judgments, member state governments should strive to find a balance between the public interest and the private rights under protection. Member state governments have the right to take such measures as they deem best to achieve the objectives of the intervention. How much leeway member state governments have for free judgment depends on the circumstances of the case. On the whole, the more important the individual rights involved in the intervention, the less room for the leeway for state judgment; in contrast, when there is no consensus among member states on the importance of individual rights and the best way to protect them, governments have more leeway to exercise their own judgment.36 Given the lack of consensus among EU member states on the need for mandatory vaccination, the Court of Human Rights made it clear that “public health issues are within the discretion of member state governments, which are better placed to judge priorities, available resources and societal needs.”37 Meanwhile, the Court of Human Rights still plays a supporting role. This means that while, in most cases, the Court respects the decisions of the member states, it places the judgments of the member states under the supervision of the EU institutions. In the case of Varif et al.v. Czech Republic, the Court of Human Rights noted that there was a consensus among member states that “vaccines are one of the medical interventions that have both effectiveness and reliability,” as reflected by the higher vaccination rates that member states strongly pursue. However, there is clearly no consensus as yet among EU member states on the view that “vaccines are the most effective measure to protect various interests.” This is why some EU countries practice mandatory vaccination while others only recommend vaccination. In this case, the Court of Human Rights holds that the power to determine national vaccine policies rests with member state governments.38
 
After reaffirming the division of competence between the EU and member states in the field of public health and the principle of “Leeway for free judgment”, the Court of Human Rights reviewed the legal provisions involved in the case:
 
In terms of the urgency of social needs, the Court of Human Rights held that the main need was to analyze whether the Czech Government’s choice to make vaccination for children mandatory constituted a response to urgent social needs. In order to prove the domestic demand for compulsory vaccination, the Czech Government submitted to the Court of Human Rights supporting documents such as statements, opinions and reports from domestic and foreign institutions, such as the Czech Association for Immunization, the Association of Children’s Doctors, the General Association of Adolescent Patients, the General Trade Union of Doctors, the governments of other EU member states, and the World Health Organization, clarifying the superior role of vaccines in protecting the health and reducing the costs of social operation. Meanwhile, the Czech Government stressed that the immune effect of the vaccine depends on a high vaccination rate, and only recommending vaccination without mandatory vaccination is not conducive to maintaining and improving the vaccination rate.39 The above material proves the unanimous agreement of the Czech medical community to maintain the mandatory vaccination measures for children in the country. The Court of Human Rights agreed with the Czech Government that an explicit obligation to vaccination was a response to urgent social needs.40
 
In terms of the appropriateness and adequacy of purpose, the Court of Human Rights held that the appropriateness and adequacy of the obligation to vaccination is reflected in the following three aspects: the effectiveness and safety of the vaccine; the highest possible vaccination rate that member governments generally pursue; the priority of children’s right to health. Among them, the third point is the strongest proof.41 Some of the complainants in the case argued that it should be primarily up to the parents of minors to decide how to serve and protect the rights and interests of children, and that the state had the right to intervene only in exceptional circumstances.42 The Court of Human Rights disagreed with the views mentioned above. The Court held that the right to children’s health, in the group sense, should be superior to parental decision-making and that the state must give priority to the former. The goal of mandatory vaccination should be to protect the health of all children. Under the guidance of this overall goal, a government has the right to implement mandatory vaccination when it considers that the measures of recommending vaccination are insufficient to protect the health of children.43
 
In terms of the requirement of compliance with the principle of proportionality, the Court of Human Rights recognized that the requirement was met between the obligation to vaccination and the goal pursued by the litigation.44 The Court mainly reviewed the following four aspects:
 
First, the appropriateness of the domestic system. Two major aspects are considered: the safety and efficacy of the vaccine and the intensity of the obligation to vaccination. On the one hand, the Court of Human Rights recognized the safety and efficacy of the vaccines mandated by the Czech Government, based on the fact that few adverse reactions occurred in the nine vaccines of mandatory vaccination. On the other hand, the Court of Human Rights pointed out that although the Czech Government requires its residents to be vaccinated, this obligation is not absolute, and there are indeed contraindications that can exempt it. The Czech government also did not carry out mandatory vaccination without the consent of the parties concerned, only imposing fines or not allowing unvaccinated children to attend preschool institutions. The Court of Human Rights found that the fine was reasonable, and the temporary exclusion from preschool is protective rather than punitive. This measure would undoubtedly affect the overall development of the children involved, but the impact time is limited to non-compulsory preschool education and is a direct result of the choices of the children’s parents.45
 
Second, domestic procedural guarantees. The Court of Human Rights noted that Czech residents who challenge the legitimacy of the obligation to vaccination could file administrative proceedings or apply for a constitutional review. The Court held that the domestic law of the country provided the guarantee of procedural justice for the administrative counterpart.46
 
Third, the transparency of the policymaking process. The plaintiffs in this case pointed out that the Czech government’s public health policy violated the principle of conflict of interest and the decision-making process lacked transparency. But this view was not supported by the Court of Human Rights. The Court of Human Rights noted that the plaintiffs did not have substantial evidence that Czech or World Health Organization experts related to the enforcement measures of the lawsuit were working under the auspices of the vaccine manufacturer.47 In terms of the transparency of decision-making, the Czech Government pointed out that the official website of the Ministry of Health of the country has published the minutes of the National Vaccine Committee multiple times. Besides, the Czech Government has held several forums for public debate on immunization policy, providing opportunities for communication between medical experts and members of relevant civil associations. The Court of Human Rights found that the decision-making process of mandatory vaccination measures in the Czech Republic met the requirements of transparency.48
 
Fourth, no-fault liability or strict liability for vaccine-caused damage. The Court of Human Rights, citing the Case of Bayture and Others v. Turkey,49 reiterated that the availability of compensation for damage to health resulting from vaccination is one of the key factors in a comprehensive assessment of the justification of the obligation to vaccination. Czech law specifies strict state liability for damage caused by mandatory vaccines, and there is no issue of compensation for damage caused by vaccines in this case. Therefore, the Court of Human Rights held that the above issues did not constitute grounds for refusing vaccination.50
 
Combined with the above views, the Court of Human Rights recognized that the mandatory vaccination measures of the Czech Government met the requirements of the principle of proportionality.
 
III. The significance of the Case of Varif et al.v. Czech Republic
 
As the first ruling of the Court of Human Rights involving the obligation to vaccination, the Case of Varif et al.v. Czech Republic stimulated the in-depth discussion among the governments of EU member states, jurists and the public on the construction of the legal system of mandatory vaccination. Together with the interpretation of the Convention by the Court of Human Rights decisions and the practice that EU law prevails over member state law, the case is destined to play an important role in public health governance in the EU and globally. Specifically, this case played a positive role in safeguarding the discretion of EU member states to formulate public health policies, strengthening the influence of EU law in the field of public health, and also provided part of the reference for judging the rationality of COVID-19 obligation to vaccination.
 
A. Safeguarding the discretion of member states to determine vaccine policies
 
In recent years, the issue of whether a country has the right to adopt mandatory vaccination measures has attracted wide attention from European citizens and governments. Some EU member states, such as the Czech Republic, France, Italy and North Macedonia, have recognized the right of legislatures to enact laws specifying obligations to vaccination and penalties for non-compliance during domestic constitutional reviews.51 However, there is far from an EU-wide consensus on whether the obligation to vaccination and mandatory vaccination are justified as interference with human rights. In fact, differences in vaccine policies are permitted by the Treaty on the Functioning of the European Union. Article 168 of the Treaty makes it clear that public health issues, including the determination of vaccine policy, are within the discretion of member states.52 The ruling of the Case of Varif et al.v. Czech Republic further strengthened the discretion of member states in making vaccine policies. However, as an effective measure to prevent and control the spread of the disease, vaccines are divided into routine vaccines and emergency vaccines according to their application.53 EU member states enjoy the discretion to establish mandatory vaccination measures for the two types of vaccines mentioned above, but the impact of the Case of Varif et al.v. Czech Republic on the two types of discretion mentioned above is different.
 
First, the justification of mandatory vaccination for routine vaccines is the matter directly addressed in the Case of Varif et al.v. Czech Republic. As the Court of Human Rights highlighted, the case was aimed at routine vaccines whose “efficacy and safety” are generally recognized by the scientific community.54 At this time, the Court of Human Rights respected the discretion of member state governments to introduce mandatory vaccination measures in accordance with domestic law on the premise of having a lawful aim and following the principle of proportionality. This undoubtedly clarifies the scope of discretion for member states that have already introduced mandatory vaccination measures for routine vaccines and those that are planning to introduce similar measures, eliminating doubts about whether the corresponding system is consistent with EU law.55
 
Second, in the context of the COVID-19 pandemic, it is natural to be concerned about whether the verdict in Case of Varif et al.v. Czech Republic means that the COVID-19 obligation to vaccination is also not contrary to EU law. The Court of Human Rights has already noted in other cases that its decisions are “used to resolve the cases at hand, and more generally, to help clarify, safeguard and develop the rules set out in the Convention and thus to help states comply with the commitments they have made as parties.”56 However, European jurists still believe that the Case of Varif et al.v. Czech Republic can only provide a reference for judging whether the emergency vaccination measures of COVID-19 conform to the principle of proportionality and EU law, and cannot directly justify such measures.57 Nevertheless, after the announcement of the ruling, some EU member states tried to respond to the attitude of the Court of Human Rights through legislative practice. Most notably, Italian legislation has made it mandatory for all businessmen and health professionals (including students) working in health institutions, social health assistance agencies, and public and private pharmacies to be vaccinated against COVID-19. Otherwise, their right to provide services or work will be suspended until the end of the COVID-19 epidemiological emergency.58 Similarly, the French Government has made it mandatory for all contacts with vulnerable people to be vaccinated against COVID-19 from September 15, 2021.59 In early 2022, the Austrian Government extended the obligation to vaccination to all adults over 18, except for exempt subjects such as pregnant women, and specified fines for failing to get vaccinated.60
 
B. Strengthening the influence of EU law in the field of public health
 
Early EC treaties, such as the 1951 Treaty of Paris and the 1957 Treaty of Rome, had little to do with public health. The 1992 Maastricht Treaty was the first treaty to address EU jurisdiction in the aforementioned areas. It lays down the essential features of this jurisdiction, for example, the principle of co-governance and the principle of subsidiarity.61 Until the outbreak of COVID-19, EU law and justice systems had little influence on member states’ public health governance. However, the spread of the pandemic has increased the impact of EU law in the field of public health; specifically, the conditions for the launch of vaccines,62 the cooperation strategies of member states to fight against the pandemic,63 the definition of priority groups for vaccination,64 and the liability for vaccine defects65 are all subject to EU law. In this context, the EU judicial institution further breaks through the traditional power limitation and promotes regional integration in the field of public health through the ruling of the Case of Varif et al.v. Czech Republic.
 
Before the Case of Varif et al.v. Czech Republic, the EU rarely interferes with member states’ vaccine policies. In 2011, Patients’ Rights in Cross-border Healthcare (Directive 2011/24/EU) promulgated by the EU specified that this directive does not refer to vaccination policies introduced only to protect the health of the national population of a member state.66 In 2014, when responding to the consultation of the courts of member states, the European Court of Justice clearly pointed out that “the issue of thw vaccination of children is not subject to the adjustment of EU law.”67 Doubtlessly, the Case of Varif et al.v. Czech Republic constitutes a breakthrough of former conditions. Although in the trial of this case, the Court of Human Rights strictly adhered to the division of functions and powers, did not directly intervene in the formulation of vaccine policies of member states, but only made clear the human rights protection standards for mandatory vaccination, it can still play a positive role in unifying the public health laws of member states. However, the Court of Human Rights has been very cautious this time in its intervention in vaccine policy. It is reflected in listening to the opinions of member state governments and social organizations and in the fact that the Court of Human Rights chose the Case of Varif et al.v. Czech Republic, which only involved the justification of routine obligation to vaccination, as the beginning of a series of judicial work:
 
In early 2021, Robert Spano, President of the Court of Human Rights, noted at his annual media briefing that the Court had accepted nine Covid-related cases. Human rights issues related to the pandemic have far-reaching implications for today’s society, and such an important issue cannot remain unresolved for long.68 Therefore, the hearing of such cases would be the focus of the Court in 2021.69 In early 2021, Spano introduced some important verdicts in his review of the previous year’s work of the Court of Human Rights, and the first case was the Case of Varif et al.v. Czech Republic. He stressed that the case was “the beginning of jurisprudence related to COVID-19.”70 Yet there are limits to what the Case of Varif et al.v. Czech Republic can teach about COVID-19 obligation to vaccination. For example, the case did not address issues such as how to judge the need for emergency measures in the event of a public health emergency. The Case of Varif et al.v. Czech Republic is more about providing a common standard for the justification of mandatory vaccination of routine and emergency vaccines from a broad perspective.
 
C. Helping in judging the rationality of COVID-19 obligation to vaccination
 
Although the Court of Human Rights attaches great importance to the Case of Varif et al.v. Czech Republic, this case is still directly concerned with the legitimacy of the obligation to routine vaccination, whose effectiveness and safety have been scientifically verified for decades, that is, human rights protection standards for the implementation of such public health measures. However, the fact that the COVID-19 vaccine was developed on an emergency basis during a major public health emergency sets it apart from traditional vaccines. Even so, the clear judgment criterion of the Case of Varif et al.v. Czech Republic still has certain guiding significance for judging the rationality of the COVID-19 obligation to vaccination. It is only necessary to take into account the particularity of COVID-19 vaccines in the process of judgment. 
 
The Court of Human Rights made it clear in the Case of Varif et al.v. Czech Republic that the obligation to vaccination constitutes an interference with fundamental human rights, which meets the requirements of the Convention only if there is a legal basis, a lawful aim and it is needed for a democratic society. In the face of the COVID-19 pandemic, it is self-evident that it is necessary to clarify the obligation to vaccination of some or all people through legislation, as well as its positive significance to public health protection. The only thing that is debatable is whether the mandatory measure conforms to the principle of proportionality in “the needs of a democratic society.” Based on the ruling of the Case of Varif et al.v. Czech Republic, the following factors need to be considered at this point: (1) The safety and efficacy of the vaccine; (2) The degree of mandatory vaccination; (3) Whether domestic laws provide corresponding procedural guarantees; (4) Whether to set up compensation measures for vaccine-caused damage.71 As mentioned above, Italy, France and other EU member states have passed legislation to clarify the obligation of some citizens to take COVID-19 vaccines. At this time, citizens enjoy the same procedural guarantees and compensation mechanisms as those who get routine vaccines. What is really controversial is whether the COVID-19 vaccine has “safety and efficacy” in the legal sense and whether the mandatory degree of obligation to vaccination is reasonable.
 
First of all, regarding the safety of vaccines, in the Case of Varif et al.v. Czech Republic, the Court of Human Rights pointed out that adverse reactions and side effects caused by vaccination are rare but still exist. Therefore, the key is whether member states provide corresponding safeguard measures while clarifying their obligations to vaccination, such as setting up the vaccination exemption mechanism based on medical contraindications and clarifying the no-fault liability for personal injury caused by vaccination, etc.72 Comparing the above requirements with the current legal system of EU member states that defines the obligation to vaccination against COVID-19, it can be seen that the latter meets the above requirements. For example, Articles 12 and 18 of Law No. 2021-1040 of August 5, 2021 on Health Crisis Management promulgated in France, clarify the exemption conditions of obligation to vaccination and the corresponding relief mechanism for personal injury, respectively.73 However, even if the corresponding safety guarantee is provided, the emergency situation of COVID-19 vaccine research and development and the current situation of conditional marketing still raise questions among jurists about its safety and the legality of the obligation to vaccination. Some jurists believe that the conditional marketing of the COVID-19 vaccine means that it is an “experimental vaccine”, and vaccination with such a vaccine should be based on the informed consent of the recipients rather than mandatory vaccination measures.74 But in fact, according to the EU Regulation 2006/507 — Conditional Marketing Authorization for Medicinal Products for Human Use, the conditional marketing of vaccines does not mean that the requirements for vaccine safety are reduced. In this regard, conditional marketing vaccines, like other medicines, need to be validated and submitted to a Benefit-risk Report during the development phase to demonstrate that the protection of public health from vaccination outweighs the potential risks.75 This means that the COVID-19 vaccine granted conditional marketing authorization in the European Union meets the safety requirements and is not an experimental drug, and getting a conditional marketing vaccine does not mean participating in experiments.76 It is worth noting that the US District Court for the Southern District of Texas reached the same conclusion in the Case of Jennifer Bridges v. Houston Methodist Hospital.77
 
Second, regarding the effectiveness of vaccines, in the Case of Varif et al.v. Czech Republic, the Court of Human Rights illustrated the positive role of high vaccination rates in reducing disease by citing material from the World Health Organization.78 In the face of the global spread of COVID-19 and newly developed vaccines, WHO has tried to address key questions such as vaccine effectiveness while stating that equitable access to safe and effective vaccines is critical to ending the COVID-19 pandemic.79 The organization considers a vaccine to be effective if it does one of the following things: cut off transmission routes, prevent harm to others, prevent serious infection and transmission, reduce hospitalization rates, protect people in hospitals, and ensure the functioning of emergency medical systems.80 Besides, WHO further specified that COVID-19 vaccines licensed for emergency use by the organization must have an efficacy rate of more than 50 percent.81 The COVID-19 vaccines conditionally marketed in the European Union have all been approved for emergency use by the WHO,82 and from this point of view, the effectiveness of the above vaccines should be recognized. Also, the EU Regulation 2006/507 — Conditional Marketing Authorization for Medicinal Products for Human Use also has requirements for the effectiveness of conditionally marketed vaccines.83
 
Finally, there is the question of whether the mandatory degree of the obligation to vaccination is reasonable, that is, whether the adverse consequences resulting from the failure to fulfill that obligation are reasonable. In the Case of Varif et al.v. Czech Republic, the main consequences of failing to meet the obligation to vaccination are fines and not being able to attend preschool institutions such as kindergartens. The Court of Human Rights found the legal consequences reasonable: The amount of the fine was acceptable; while not being able to attend a preschool is “a protective measure instead of a punishment” and does not deprive a child of compulsory education.84 However, under current law in member states such as France and Italy, the legal consequences of non-compliance with COVID-19 obligation to vaccination are slightly different from the case of Varif et al.v. Czech Republic. Most COVID-19 obligations to vaccination are related to the occupation of the person getting the vaccine, so the most common legal consequence of refusing to fulfill the obligation to vaccination is “suspension of labor contract performance until the end of the health emergency.”85 The French and Italian laws mentioned above have similar provisions. Whether such mandatory measures are consistent with the principle of proportionality is an issue of the times to which judicial institutions must respond. The verdict of the Case of Varif et al.v. Czech Republic does not involve the rationality of such mandatory measures, so there is no reference in this respect. But the Court of Human Rights has partially responded to this issue in subsequent judicial activities:
 
After France promulgated its Law No. 2021-1040 of August 5, 2021 on Health Crisis Management, more than 600 vaccinated firefighters applied to the Court of Human Rights, asking it to initiate temporary measures under Article 39 of the European Court of Human Rights Rules to suspend the law, including suspending obligation to vaccination and restoring the right to work and pay for unvaccinated people.86 The Court of Human Rights held that the above application is considered admissible. This is the first substantive review by the Court of Human Rights of a member state’s COVID-19 obligation to vaccination.87 In this review, being restricted by the procedure, the Court of Human Rights did not form a judgment document as long as the ruling of the Case of Varif et al.v. Czech Republic nor address specific issues such as whether the COVID-19 obligation to vaccination complies with the Convention. It simply refused to initiate temporary measures. The Court noted that such measures apply only in exceptional cases where failure to initiate them immediately would not “expose the applicant to a real risk of irreversible loss.”88 This decision shows that the Court of Human Rights recognizes the rationality of the mandatory measures in dispute to a certain extent. 
 
Indeed, the recognition of the reasonableness of the COVID-19 obligation to vaccination of the Court of Human Rights is not unique. Except for the Case of Jennifer Bridges v. Houston Methodist Hospital in the US, WHO launched the policy for mandatory vaccination against COVID-19 in April 2021 after extensive consultations with countries and organizations interested in implementing the policy: COVID-19 and Mandatory Vaccination: Ethical Considerations.89 Although the policy has a binding force, it still plays a role in creating global health rules and systems to a certain extent.90 In light of the pandemic, the WHO points out the following six main factors that should be considered when implementing mandatory vaccination measures against COVID-19: necessity and proportionality; sufficient evidence of vaccine safety; sufficient evidence of vaccine efficacy and effectiveness; adequate supply; public trust and the ethical process of decision-making. The mandatory obligation to vaccination for COVID-19 vaccines that meets the above requirements can be considered reasonable. Comparing the above requirements of WHO with the views expressed by the Court of Human Rights in the Case of Varif et al.v. Czech Republic, it can be seen that the two are basically consistent. The Case of Varif et al.v. Czech Republic did not involve the requirement of sufficient vaccine supply, but the European Union has also introduced corresponding policies to ensure sufficient vaccine supply and fair distribution in the process of organizing COVID-19 vaccine procurement and distribution in member states.91
 
Looking back at the history of the human struggle against disease, mandatory vaccination measures aimed at preventing or even eliminating diseases are not new, and this process has always been accompanied by restrictions on human rights.92 The key is to limit the violation of fundamental human rights by mandatory vaccination measures to a necessary and reasonable degree through scientific demonstration and democratic consultation. Meanwhile, it should be realized that mandatory vaccination is not the only way to improve the vaccination rate and ensure the immune effect. Only when mandatory vaccination measures are combined with non-compulsory measures such as national health education, simplified vaccination procedures, and economic and non-economic incentives for those who have been vaccinated can public health protection be achieved without restricting individual freedom or minimizing restrictions on individual freedom.
 
(Translated by LI Donglin)
 
* CHEN Yunliang ( 陈云良 ), Professor at Center for Medical and Health Law, Central South University.
 
** MO Tingting ( 莫婷婷 ), PhD candidate of Law School of Central South University, Lecturer of Guangxi University of Finance and Economics.
 
1. Loi du 15 février 1902 relative à la protection de la santé publique. See Le Parlement et la santé, Didier Tabuteau, Dans LES TRIBUNES DE LA SANTé 2012/1 (n° 34), PAGES 95 à 115.
 
2. M Haverkate & F D’Ancona et al., “Mandatory and recommended vaccination in the EU, Iceland and Norway: results of the VENICE 2010 survey on the ways of implementing national vaccination programmes”, 17 Eurosurveillance, issue 22 (31 May 2012); Simona-Nicoleta Vulpe & Cosima Rughinis, Social amplification of risk and “probable vaccine damage”: A typology of vaccination beliefs in 28 European countries, 39 Vaccine, issue 10 (5 March 2021), page 1508-1515.
 
3. Case of Vavřička and Others. The Czech Republic, ECHR (Applications nos.47621/13 and 5 others), Judgement of 8 April, 2021.
 
4. Ibid., para.310. 
 
5. Frédéric Sudre & Laure Milano et al, Droit européen et international des droits de l’ homme, 14eéd., Paris: PUF, 2019, page 384-385; Catherine Gauthier & Sébastien Platon et al, Droit européen des droits de l’ homme, Paris: Sirey, 2017, page 396-397.
 
6. Case of Guzzardi v. Italy, ECHR (Applications nos.7367/76), Judgment of 6 November, 1980, para.86.
 
7. Case of Vavřička and Others. The Czech Republic, ECHR (Applications nos.47621/13 and 5 others), Judgement of 8 April, 2021, para.11. 
 
8. Ibid., paras.73-77. 
 
9. Ibid., para.15. 
 
10. Ibid., para.17. 
 
11. Ibid., paras.18-20.
 
12. Ibid., paras.23-24. 
 
13. Ibid., para.25. 
 
14. Ibid., para.27.
 
15. Ibid., paras.28-29. 
 
16. Ibid., paras.30-31.
 
17. Ibid., para.93. 
 
18. Ibid., para.160; para.313, para.339: It should be noted that Czech Varif was fined about EUR 110 because his children were not vaccinated. The children of the other five plaintiffs failed to be admitted to the kindergarten because they refused to perform their obligations to vaccination.
 
19. Ibid, paras.1-10. 
 
20. Ibid, para 87. 
 
21. Ibid. 
 
22. Ibid, paras.330-332. 
 
23. Ibid., para.345. 
 
24. Separate Opinions. Case of Vavřička and Others v. The Czech Republic, ECHR (Applications nos.47621/13 and 5 others), Judgment of 8 April, 2021.
 
25. Paradiso and Campanelli v. ltaly[GC], n25358/12, Judgment of 24 January, 2017, para.159.
 
26. Case of Vavřička and Others. The Czech Republic, ECHR (Applications nos.47621/13 and 5 others), Judgement of 8 April, 2021, para.265. 
 
27. Ibid, para.310. 
 
28. Ibid., para.269. 
 
29. Ibid., para.266.
 
30. Ibid., para.267. 
 
31. Ibid., para.197. 
 
32. Ibid., para.272. 
 
33. Case of Dubská and Krejzov v.The Czech Republic, ECHR (Applications nos.28859/11 and 28473/12), Judgment of 15 November, 2016, paras.66 and 174-178. In that case, the Court of Human Rights pointed out that under Article 8, paragraph 2, of the Convention, public power may impose necessary restrictions on human rights. The restriction does not violate the Convention as long as it is derived from the provisions of the law, has a lawful aim and is needed for a democratic society. The Case of Varif et al.v. Czech Republic is also an issue involving human rights restrictions; therefore, part of the ruling of the Case of Dubska and Krejzov v. the Czech Republic is followed. Besides, the Case of Varif et al.v. Czech Republic focuses on the restriction of human rights by public power in daily situations, and does not address the issue of human rights derogation in emergency situations. Therefore, the standards of human rights derogation and protection specified in Article 15 of the Convention and the case of Lawless v. Ireland, ECHR, n° 332/57, 1 July1961 are not reflected in the Case of Varif et al.v. Czech Republic.
 
34.Case of Fernández.Martínezt.Spain,ECHR(Applications nos.56030/07),Judgment of 12 June,2014,para.124.
 
35. Case of Vavřička and Others. The Czech Republic, ECHR (Applications nos.47621/13 and 5 others), Judgement of 8 April, 2021, para.273. 
 
36. Ibid., para.273. 
 
37. Ibid., para.274. 
 
38. Ibid., paras.276-280. 
 
39. Ibid, para.283.
 
40. Ibid., para.284.
 
41. Ibid., para.285. 
 
42. Ibid., para.286. 
 
43. Ibid., paras.287-289. 
 
44. Ibid., para.309. 
 
45. Ibid., paras.291-294.
 
46. Ibid., para.295. 
 
47. Ibid., para.297. 
 
48. Ibid., para.298. 
 
49. Case of Bayture and Others v. Turkey, ECHR (Applications no.3270/09), Judgment of 24 march, 2014, paras.28-30.
 
50. Case of Vavřička and Others. The Czech Republic, ECHR (Applications nos.47621/13 and 5 others), Judgement of 8 April, 2021, para.302. 
 
51. (Czech)Constitutional Court., 27 January 2015, n?Pl.US 19/14; (France) Conseil Constitutional, 20 mars 2015, no.2015-458QPC; (Italy) Constitutional Court., 22 November 2017, no.5/2018; (North Macedonia) Constitutional Court, 8 October 2014, no.Pl.US 19/14 U.Br.30/2014.
 
52. Treaty on the Functioning of the European Union (TFEU) Article 168 (7): “Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care. The responsibilities of the Member States shall include the management of health services and medical care and the allocation of the resources assigned to them.”
 
53. Chen Yunliang, “Citizens’ Obligation to Vaccination: Understanding and Application of Article 21 of the Basic Medical Care and Health Promotion Law,” ECUPL Journal 4 (2021): 96-106. 
 
54. Case of Vavřička and Others. The Czech Republic, ECHR (Applications nos.47621/13 and 5 others), Judgement of 8 April, 2021, para.285 and para.290. 
 
55. Maïté Saulier, “Obligation vaccinale: I’arrêt prophétique de la CEDH?Decision rendue par Cour europeenne des droits de’homme,” AJFamile (2021): 309.
 
56. Case of Guzzardi v. Italy, ECHR (Applications nos.7367/76), Judgment of 6 November, 1980, para.86.
 
57. Jean-pierre Marguénaud, “La vaccination infantile obligatoire au test des droits de homme”, RTD Civ, 2021, page 364.Same views. See Maïté Saulier, “Obligation vaccinale: I’arret prophetique de la CEDH?Decision rendue par Cour europeenne des droits de’homme,” 309. It is worth noting that the above two articles are case notes attached to the reprinting of the ruling the Case of Varif et al.v. Czech Republic by authoritative French law journals, which have a certain “quasi-official” nature.
 
58. DECRETO-LEGGE 1aprile 2021, n.44.Misure urgenti per il contenimento del’epidemia da COVID-19, in materia di vaccinazioni anti SARS-CoV-2, di giustizia e di concorsi publici. (21G00056).
 
59. Loi no 2021-1040 du 5 aout 2021 relative à la gestion de la crise sanitaire.
 
60. Alex Halada, “Covid-19: I’ Autriche instaure officiellement la vaccination obligatoire,” Le Monde (8 March 2022), https://www.lemonde.fr/planete/article/2022/02/05/covid-19-1-autriche-instaure-officiellement-la-vaccination-obligatoire_6112473_3244.html.
 
61. Nathalie de Grove-Valdeyron, Droit européen de la santé, Paris:L.G.D.J, 2013, P.19-30: The principle of co-governance means that public health is not the exclusive domain of the European Union, but the EU shares jurisdiction with member states in this area; The principle of subsidiarity means that the main responsibility of the EU in this field is to provide necessary support and supplement to the member states.
 
62. Règlement (CE) N°507/2006 DE LA COMMISSION du 29 mars 2006 relatif à l’ autorisation de mise sur le marché conditionnelle de médicaments à usage humain relevant du règlement (CE) n°726/2004 du Parlement européen et du Conseil.
 
63. Commission Européen, COMMUNICATION DE LA COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL-Préparation aux stratégies de vaccination et au déploiement de vaccins contre la COVID-19: Doc. COM (2020) 680 final, 15 octobre 2020.
 
64. Estelle Brosset, “Vaccins et vaccination contre la COVID-19: le droit de I’Union la ou on ne I’attend pas,”LEXISNEXIS SA, No.1 (janvier 2022), page 1-5.
 
65. Directive 85/374/CEE du Conseil du 25 juillet 1985 relative au rapprochement des dispositions législatives, réglementaires et administratives des Etats membre en matière de responsabilité du fait des produits défectueux.
 
66. Para. 1 de l’ article 1 du Directive 2011/24/UE DU PARLEMENT EUROPEEN ET DU CONSEIL du 9 mars 2011 relative à l’ application des droits des patients en matière de soins de santé transfrontaliers.
 
67. L’ ordonnance de la Cour de Justice de l’ Union européen n°C-459/13 du 17 juillet 2014.
 
68. Maite Saulier, “Obligation vaccinale: I’arret prophetique de la CEDH?Decision rendue par Cour europeenne des droits de’homme,” AJFamile (2021): 364.
 
69. Jean-Pierre Marguénaud, “Cour européenne des droits de l’ homme: conférence de presse annuelle 2021,” Dalloz actualité, 1 février 2021.
 
70. Jean-Pierre Marguénaud, “Chronique CEDH: suspension de la Fédération de Russie”, Dalloz actualité, 9 mars 2022.
 
71. Case of Vavřička and Others. The Czech Republic, ECHR (Applications nos.47621/13 and 5 others), Judgement of 8 April, 2021, paras.290-309. 
 
72. Ibid., para.301. 
 
73. Loi n 2021-1040 du 5 aout 2021 relative à la gestion de la crise sanitaire.
 
74. Case of Guzzardi v. Italy, ECHR (Applications nos.7367/76), Judgment of 6 November, 1980, para.86. Similarly, L. O. Gostin, a professor of health law in the United States, also believes that conditional marketing of vaccines should not be used for mandatory vaccination, because the application for conditional marketing requires less safety and efficacy data than the application for formal marketing authorization: see. L. O. Gostin, D. A. Salmon, H. J. Larson, Mandating COVID-19 vaccines.JAMA.2020; 325 (6), pp.532-533.
 
75. Reglement (CE) N°507/2006 DE LA COMMISSION du 29 mars 2006 relatif à l’ autorisation de mise sur le marché conditionnelle de médicaments à usage humain relevant du règlement (CE) n°726/2004 du Parlement européen et du Conseil, para.3 du préambule.
 
76. Caroline Lantero & David Braustein, “Sur la licéité d’ une obligation vaccinale anti-covid-2,” Revenue des droits et libertés fondamentaux, chron. no. 25, 2021.
 
77. Jennifer Bridges v. Houston Methodist Hospital, No.4: 21-cv-01774 (S.D.Texas), para.3.
 
78. Case of Vavřička and Others. The Czech Republic, ECHR (Applications nos.47621/13 and 5 others), Judgement of 8 April, 2021, para.300. 
 
79. WHO, “Covid-19 Vaccines” (8 March 2022), https://www.who.int/emergencies/diseases/novel-corona-virus-2019/covid-19-vaccines.
 
80. WHO, “COVID-19 and mandatory vaccination: Ethical considerations and caveats” (13 April2021), https://
www.who.int/publications/i/item/WHO-2019-nCoV-Policy-brief-Mandatory-vaccination-2021.1.
 
81. WHO, Vaccine Efficacy, Effectiveness and Protection (2021-7-14), https://www.who.int/zh/news-room/feature-stories/detail/vaccine-efficacy-effectiveness-and-protection.
 
82. WHO, Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process (02 March 2022), https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_02 March2022.pdf.
 
83. Reglement (CE) N°507/2006 DE LA COMMISSION du 29 mars 2006 relatif à l’ autorisation de mise sur le marché conditionnelle de médicaments à usage humain relevant du règlement (CE) n°726/2004 du Parlement européen et du Conseil, para.3 du préambule.
 
84. Case of Vavřička and Others. The Czech Republic, ECHR (Applications nos.47621/13 and 5 others), Judgement of 8 April, 2021, para.306. 
 
85. It should be noticed that in “the Case of Jennifer Bridges v. Houston Methodist Hospital” in the US, the District Court for the Southern District of Texas even held that the mandatory action of “firing employees who fail to comply with obligations to vaccination” was justified. See Jennifer Bridges v. Houston Methodist Hospital, No.4: 21-cv-01774 (S.D.Texas), para.2. 
 
86. European Court of Human Rights, Communiqué de presse de la Greffière de la Cour, sur Les demandes de mesures provisoires de 672 sapeurs-pompiers concernant la loi relative à la gestion de la crise sanitaire n’ entrent pas dans le champ d’ application de l’ article 39 du règlement de la Cour, CEDH 243 (2021), le 25 aoút 2021.
 
87. Mustapha Afroukh, Le (recours collectifs) contre le passe sanitaire ne passe pas à Strasbourg! Dalloz actualité, 19 octobre 2021.
 
88. WHO, Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process (02 March 2022), https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_02 March2022.pdf. 
 
89. WHO, “Covid-19 Vaccines” (8 March 2022), https://www.who.int/emergencies/diseases/novel-corona-virus-2019/covid-19-vaccines. 
 
90. Dai Tao, Wei Xiao and Guo Yan, “World Health Organization Policy: Types and Characteristics,” Chinese Journal of Health Policy 4 (2010). 
 
91. Estelle Brosset, “Vaccins et vaccination contre la COVID-19: le droit de I’Union la ou on ne I’attend pas,” LEXISNEXIS SA, No.1 (janvier 2022), page 1-5. 
 
92. Cheng Guansong and Fang Jiu, “Legal Protection of Interim Relief for People in Difficulty Caused by Emergency Measures for Pandemic Prevention,” Law-Based Society 2 (2021).