21 March 2022 3:59 PM GMT
The Supreme Court, on Monday, continued hearing submissions made by the Solicitor General of India, Mr. Tushar Mehta in the plea seeking directions to the Central Government to publicize the data pertaining to the clinical trials of the COVID-19 vaccines administered in India and their post vaccine efficacy as per the requirement of the International medical norms. Mr. Mehta...
The Supreme Court, on Monday, continued hearing submissions made by the Solicitor General of India, Mr. Tushar Mehta in the plea seeking directions to the Central Government to publicize the data pertaining to the clinical trials of the COVID-19 vaccines administered in India and their post vaccine efficacy as per the requirement of the International medical norms. Mr. Mehta primarily argued that an individual's personal liberty is not absolute and it is the duty of the court to reconcile competing interests by balancing the interests so involved.
On the last date of hearing when Mr. Mehta commenced with his submissions, at the outset, he had questioned the bona fides of the petitioner. He contended that by way of a Public Interest Litigation, the petitioner cannot seek raw data of the clinical trial of the COVID-19 vaccines, merely to satisfy his curiosity, nor can he sit in judgment of the wisdom of the statutory bodies comprising domain experts.
Thereafter, he took the Bench comprising Justices L. Nageswara Rao and B.R. Gavai through the relevant provisions of the Drugs and Cosmetics Act and the Drugs and Cosmetics Act and the New Drugs and Clinical Trials Rules 2019 to demonstrate the protocols of the vaccine approval process was followed by the Union Government. He further referred to Epidemic Disease Act, Disaster Management Act to indicate the wide scope of power granted to the Union Government by various statutes to take measures during a pandemic.
Advocate, Mr. Prasant Bhushan appearing for the petitioner had argued non-disclosure of data is depriving the citizens from making informed consent. Addressing the issue of 'coercive' vaccine mandates imposed by Maharashtra, Madhya Pradesh, Delhi and Tamil Nadu, which is also under challenge in the said petition, he stated that the presence of the such mandates in an environment where the data pertaining to clinical trial is not available is violative of right to self-determination protected by Article 21 of the Constitution of India. Mr. Bhushan had also argued in favour of revamping the Adverse Events Following Immunization (AEFI), reporting system which, he claimed, lacked transparency. Another issue before the Bench was non-disclosure of clinical trial data for the vaccines that are being administered to children in India.
While addressing the issue of the AEFI reporting system, Mr. Mehta had submitted that a robust mechanism was already in place and the same, he argued, was transparent. He controverted the evidence pertaining to vaccination for children stating that the nature of vaccine administered in India was completely different from the one that the petitioner had relied on to adduce evidence.
On Monday, at the outset, Mr. Mehta refuted the petitioner's argument that the ingredient of the vaccine was unknown.
"The argument of the petitioner was, that we are not aware what this vaccine is. I had shown that everything was in the public domain except for one document, which I could not point out, which is also in the public domain. I am showing for Covaxin, your lordships may take it that similar is available for Covishield. I'll not duplicate by reading two."
He referred to the Counter Affidavit filed by him to argue that all information, including Qualitative and Quantitative Composition; pharmaceutical form; clinical particulars; therapeutic indications; contra-indication; special warning and precaution; Clinical Trial experience, which at the end says that related adverse events were observed; Immune response; Pharmacological properties; preclinical safety data was available in the public domain. He further stated that the Vaccine Vial Monitor was also being updated on a real-time basis.
Mr. Mehta referred to a catena of foreign judgments relating to vaccination in general, and the vaccination during the COVID-19 pandemic in particular to indicate that individual liberty is not absolute and is subject to other factors. He emphasised that until and unless the decision taken by the State is manifestly arbitrary, unreasonable, ultra vires, it ought not to be inferred with.
He referred to Jacobson v. Massachusetts, 197 U.S. 11 (1905), wherein the Supreme Court of the United States (SCOTUS) had upheld the authority of the State to enforce compulsory vaccination laws.
"It seems to the court that an affirmative answer to these questions would practically strip the legislative department of its function to care for the public health and the public safety when endangered by epidemics of disease. Such an answer would mean that compulsory vaccination could not, in any conceivable case, be legally enforced in a community, even at the command of the legislature, however widespread the epidemic of smallpox, and however deep and universal was the belief of the community and of its medical advisers, that a system of general vaccination was vital to the safety of all.
We are not prepared to hold that a minority, residing or remaining in any city or town where smallpox is prevalent, and enjoying the general protection afforded by an organized local government, may thus defy the will of its constituted authorities, acting in good faith for all, under the legislative sanction of the State. If such be the privilege of a minority, then a like privilege would belong to each individual of the community, and the spectacle would be presented of the welfare and safety of an entire population being subordinated to the notions of a single individual who chooses to remain a part of that population. We are unwilling to hold it to be an element in the liberty secured by the Constitution of the United States that one person, or a minority of persons, residing in any community and enjoying the benefits of its local government, should have the power thus to dominate the majority when supported in their action by the authority of the State. While this court should guard with firmness every right appertaining to life, liberty or property as secured to the individual by the Supreme Law of the Land, it is of the last importance that it should not invade the domain of local authority except when it is plainly necessary to do so in order to enforce that law. The safety and the health of the people of Massachusetts are, in the first instance, for that Commonwealth to guard and protect. They are matters that do not ordinarily concern the National Government. So far as they can be reached by any government, they depend, primarily, upon such action as the State in its wisdom may take, and we do not perceive that this legislation has invaded any right secured by the Federal Constitution."
Mr. Mehta submitted that on the last occasion Justice Rao had indicated that in order to be considered valid, the vaccine mandates ought to stand the test of proportionality. In this regard he took the Court's attention to the relevant portion which, he thought, addressed the issue of proportionality -
"Before closing this opinion, we deem it appropriate, in order to prevent misapprehension as to our views, to observe -- perhaps to repeat a thought already sufficiently expressed, namely -- that the police power of a State, whether exercised by the legislature or by a local body acting under its authority, may be exerted in such circumstances or by regulations so arbitrary and oppressive in particular cases as to justify the interference of the courts to prevent wrong and oppression. Extreme cases can be readily suggested. Ordinarily such cases are not safe guides in the administration of the law. It is easy, for instance, to suppose the case of an adult who is embraced by the mere words of the act, but yet to subject whom to vaccination in a particular condition of his health or body, would be cruel and inhuman in the last degree. We are not to be understood as holding that the statute was intended to be applied to such a case, or, if it as so intended, that the judiciary would not be competent to interfere and protect the health and life of the individual concerned."
Summarising the conclusion of the SCOTUS, Mr. Mehta stated that it had decided to rely on the wisdom of the executive because it had effectively addressed competing fundamental rights.
Thereafter, he alluded to Zutch v. King, wherein the SCOTUS had followed its judgment in Jacobson and held that it was constitutional to exclude unvaccinated students from attending school in the district of San Antonia, Texas. He relied on Phillips v. City of New York, wherein the United States Court of Appeals, Second Circuit upheld the mandate imposed by the New York State, which required children to get vaccinated in order to attend public school.
"Plaintiffs brought this action challenging on constitutional grounds New York State's requirement that all children be vaccinated in order to attend public school. Plaintiffs argued that the statutory vaccination requirement, which is subject to medical and religious exemptions, violates their substantive due process rights, the Free Exercise Clause of the First Amendment, the Equal Protection Clause of the Fourteenth Amendment, the Ninth Amendment, and both state and municipal law. On the same grounds, plaintiffs argued that a state regulation permitting school officials to temporarily exclude from school students who are exempted from the vaccination requirement during an outbreak of a vaccine-preventable disease is unconstitutional.
Plaintiffs argue that a growing body of scientific evidence demonstrates that vaccines cause more harm to society than good, but as Jacobson made clear, that is a determination for the legislature, not the individual objectors.
Plaintiffs next argue that the temporary exclusion from school of the Phillips and Mendoza–Vaca children during the chicken pox outbreak unconstitutionally burdens their free exercise of religion. Jacobson did not address the free exercise of religion because, at the time it was decided, the Free Exercise Clause of the First Amendment had not yet been held to bind the states. See Cantwell v. Connecticut, 310 U.S. 296, 303 (1940). Therefore, Jacobson does not specifically control Phillips's and Mendoza–Vaca's free exercise claim. The Supreme Court has stated in persuasive dictum, however, that a parent "cannot claim freedom from compulsory vaccination for the child more than for himself on religious grounds. The right to practice religion freely does not include liberty to expose the community or the child to communicable disease or the latter to ill health or death." Prince v. Massachusetts, 321 U.S. 158, 166–67 (1944). That dictum is consonant with the Court's and our precedents holding that "a law that is neutral and of general applicability need not be justified by a compelling governmental interest even if the law has the incidental effect of burdening a particular religious practice." Church of the Lukumi Babalu Aye, Inc. v. City of Hialeah, 508 U.S. 520, 531 (1993); accord, Leebaert v. Harrington, 332 F.3d 134, 143–44 (2d Cir.2003) (holding that parental claims of free exercise of religion are governed by rational basis test). Accordingly, we agree with the Fourth Circuit, following the reasoning of Jacobson and Prince, that mandatory vaccination as a condition for admission to school does not violate the Free Exercise Clause. See Workman v. Mingo County Bd. of Educ., 419 F. App'x 348, 353–54 (4th Cir.2011) (unpublished).
New York could constitutionally require that all children be vaccinated in order to attend public school. New York law goes beyond what the Constitution requires by allowing an exemption for parents with genuine and sincere religious beliefs. Because the State could bar Phillips's and Mendoza–Vaca's children from school altogether, a fortiori, the State's more limited exclusion during an outbreak of a vaccine-preventable disease is clearly constitutional."
On an earlier occasion, Mr. Bhushan had informed the Bench that the mandate imposed by the Delhi Government had been lifted. On Monday, Mr. Mehta apprised the Bench that the vaccine mandate of the State of Madhya Pradesh restricting access to ration had been withdrawn.
"I must point out at the outset that the mandate given by Madhya Pradesh that if there is no vaccination no ration would be given. I was not aware then, but I was later informed that it was initially issued but immediately withdrawn. Now, the examples, like in Maharashtra, if you want to take the metro you have to be vaccinated or if you want to go to malls or some crowded places vaccination is mandatory."
He referred to the recent judgment of the SCOTUS in Joseph R. Biden, Jr. President of the United States v. Missouri, wherein it had upheld the policy of the State to mandate vaccination for healthcare workers. Mr. Mehta stressed that the SCOTUS had observed that the State had taken a conscious decision after examining relevant data to mandate vaccination.
"And his response is not a surprising one. Vaccination requirements are a common feature of the provision of healthcare in America: Healthcare workers around the country are ordinarily required to be vaccinated for diseases such as hepatitis B, influenza, and measles, mumps, and rubella. CDC, State Healthcare Worker and Patient Vaccination Laws (Feb. 28, 2018), https://www.cdc.gov/ phlp/publications/topic/vaccinationlaws.html. As the Secretary explained, these pre-existing state requirements are a major reason the agency has not previously adopted vac- cine mandates as a condition of participation.
All this is perhaps why healthcare workers and public health organizations overwhelmingly support the Secretary's rule. See id., at 61565–61566; see also Brief for American Medical Assn. et al. as Amici Curiae; Brief for American Public Health Assn. et al. as Amici Curiae; Brief for Secretaries of Health and Human Services et al. as Amici Curiae. Indeed, their support suggests that a vaccination requirement under these circumstances is a straightforward and predictable example of the "health and safety" regulations that Congress has authorized the Secretary to impose.
We accordingly conclude that the Secretary did not exceed his statutory authority in requiring that, in order to remain eligible for Medicare and Medicaid dollars, the facilities covered by the interim rule must ensure that their employees be vaccinated against COVID–19.
We also disagree with respondents' remaining contentions in support of the injunctions entered below. First, the interim rule is not arbitrary and capricious. Given the rule-making record, it cannot be maintained that the Secretary failed to "examine the relevant data and articulate a satisfactory explanation for" his decisions to (1) impose the vaccine mandate instead of a testing mandate; (2) require vaccination of employees with "natural immunity" from prior COVID–19 illness; and (3) depart from the agency's prior approach of merely encouraging vaccination. Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Auto- mobile Ins. Co., 463 U. S. 29, 43 (1983); see 86 Fed. Reg. 61583, 61559–61561, 61614. Nor is it the case that the Secretary "entirely failed to consider" that the rule might cause staffing shortages, including in rural areas. State Farm, 463 U. S., at 43; see 86 Fed. Reg. 61566, 61569, 61607–61609. As to the additional flaws the District Courts found in the Secretary's analysis, particularly concerning the nature of the data relied upon, the role of courts in reviewing arbitrary and capricious challenges is to "simply ensur[e] that the agency has acted within a zone of reasonableness." FCC v. Prometheus Radio Project, 592 U. S. ___, ___ (2021) (slip op., at 12)
The challenges posed by a global pandemic do not allow a federal agency to exercise power that Congress has not conferred upon it. At the same time, such unprecedented circumstances provide no grounds for limiting the exercise of authorities the agency has long been recognized to have. Because the latter principle governs in these cases, the applications for a stay presented to JUSTICE ALITO and JUSTICE KAVANAUGH and by them referred to the Court are granted."
Mr. Mehta submitted that while arguing Mr. Bhushan had relied on the said judgment and the stay granted by the Sixth Circuit, United States Court of Appeals, which was refused by the SCOTUS.
"My Ld. Friend for the petitioner had relied on the stay granted by the Circuit Court. This Supreme Court judgment stays that judgment which was unfortunately not brought to your lordships' notice."
Justice Rao clarified that Mr. Bhushan had cited the order in the OSHA (Occupational Safety and Health Administration) matter, wherein an executive order was passed with an imposition that any industry with more than 200 workers needs to vaccinate its workers.
Mr. Mehta referred to the dissenting opinion of the SCOTUS in National Federation Of Independent Business v. Department of Labour, Occupational Safety and Health Administration wherein it had stayed the OSHA's vaccine mandate. He pointed out that the same had been ordered citing lack of competence to issue such impositions, which is not the case in the present matter before the Bench. Stating that both majority and minority opinion of a foeign judgment would be of persuasive value, he quoted the dissenting opinion as under -
"And then, there is this Court. Its Members are elected by, and accountable to, no one. And we "lack the back- ground, competence, and expertise to assess" workplace health and safety issues. South Bay United Pentecostal Church, 590 U. S., at ___ (opinion of ROBERTS, C. J.) (slip op., at 2). When we are wise, we know enough to defer on matters like this one. When we are wise, we know not to displace the judgments of experts, acting within the sphere Congress marked out and under Presidential control, to deal with emergency conditions. Today, we are not wise. In the face of a still-raging pandemic, this Court tells the agency charged with protecting worker safety that it may not do so in all the workplaces needed. As disease and death continue to mount, this Court tells the agency that it cannot respond in the most effective way possible. Without legal basis, the Court usurps a decision that rightfully belongs to others. It undercuts the capacity of the responsible federal officials, acting well within the scope of their authority, to protect American workers from grave danger."
Justice Rao remarked -
"This judgment referred to here, South Bay United Pentecostal Church v. Newsom, pertains to restriction in church of not more than 100 people. The order was passed by the Supreme Court stating that we do not want to interfere with legislative discretion solely on the basis of Jacobson. We will see that."
He cited Vavřička And Ors. v. The Czech Republic, a judgment pertaining to children's vaccine mandate, decided by the Grande Chamber of the European Court of Human Rights, comprising upto 17 judges. The ECHR had decided that Czech Republic had not violated the European Convention on Human Rights by imposing a vaccine mandate on children. Mr. Mehta submitted -
"They (ECHR) have analysed various legal systems prevailing in each country and how each country has dealt with the question of vaccination in their jurisdiction."
He quoted the relevant portion as under -
97. The Constitutional Council ruled that the legislature was free to shape a vaccination policy to protect individual and public health. It was not for the Constitutional Council, which did not enjoy the same general power of assessment and decision-making as Parliament, to call into question the provisions enacted by the legislator, having regard to the state of scientific knowledge, or to seek to establish whether the objective of health protection set by the legislature might have been attained by other means, since the arrangements provided for by the law were not manifestly inappropriate to the objective pursued.
99. The court found, inter alia, that the protection of children's health justified compulsory vaccination at certain ages and accepted the legislature's position, based on scientific knowledge, that the benefits of vaccination for both the individual and society outweighed any possible harm due to side‑effects. The system of compulsory vaccination thus did not contravene children's right to physical integrity. At the same time, the court acknowledged that the system of compulsory vaccination might result in more significant harm for parents who, for reasons of religious conviction or conscience, did not agree with vaccination. The regulation was however in accordance with the requirements of the neutrality of the State. The legal norms in question, being binding on everybody and protecting the health of the children concerned, all other children, and in fact society as a whole, were based on postulates of the natural sciences, rather than the acceptance of the truth content of different ideologies.
102. Mandatory vaccination could not be called into question with regard to the constitutional provisions on the rights and duties of citizens in relation to the protection and promotion of their own health and that of others. Neither could it be questioned with regard to the provisions on the right and duty of parents to take care of and raise their children. A refusal of a vaccination by the parents not only endangered the health of their children, but also the health of other persons who had not been vaccinated on account of medical contraindications, and it thus denied them the right to a healthy life.
103. In order to safeguard the health of the child and the child's right to health, which was subject to a special level of protection, it was justified to deny the parents' freedom to refuse vaccination, since the right of the child to health prevailed over the parents' right to choose.
108. Pointing out that there was no scientific basis for the existing trends in popular opinion which considered vaccination to be futile or dangerous, the court noted that, in medical practice, recommendation and obligation were conjoined concepts and, therefore, moving six vaccinations from being simply recommended to being compulsory did not represent a significant change in their status. It also held that requiring a certificate for school enrolment and imposing fines were both reasonable measures for the legislature to take, not least where it had provided for initial steps to be taken before the imposition of such sanctions, i.e. one-to-one meetings with parents and guardians to inform them about the efficacy of vaccinations.
109. The court drew attention to its established case-law to the effect that, in the area of vaccinations, there was a requirement for balance between the individual right to health (including freedom concerning treatment) and the coexistent and reciprocal rights of others and the interests of the community, as well as, in the case of compulsory vaccinations, the interests of children, who required protection even vis-à-vis parents who did not fulfil their duties of care.
111. A law imposing a health-related treatment was not incompatible with the Constitution if: the treatment was intended not only to improve or maintain the health of the recipient, but also to preserve the health of others; the treatment was not expected to have a negative impact on the health of the recipient, with the exclusive exception of those consequences that normally arose and, as such, were tolerable; and, in the event of further injury, the payment of just compensation to the injured party was provided for, separate and apart from any damages to which they might be entitled.
112. The court also noted that the issue of vaccination involved many constitutional values, the coexistence of which left room for legislative discretion in choosing the means by which to ensure the effective prevention of infectious diseases. That discretion had to be exercised in the light of the various health and epidemiological conditions, as ascertained by the responsible authorities and of the constantly evolving discoveries of medical research, to which the legislature had to turn for guidance when making its choices in that area.
Republic of Moldova
117. Among other things, the court noted that the legitimate aims pursued by the challenged provisions were the protection of children's health and public health from severe illnesses which spread more when vaccination rates were lower. A restriction on access by unvaccinated children, who had no contraindications, for a limited time pending their vaccination, was a less intrusive measure in terms of the right to respect for private life and to education and would efficiently achieve the aims pursued.
118. The court balanced the principle of health protection with the principles of access to education and respect for private life. Refusing to vaccinate children with no contraindications might not only entail their possible exclusion, pending their vaccination, but also exposed them to the risk of contracting an illness. The damage to their health also had negative effects on other rights they were entitled to enjoy.
120. The children of parents who did not wish them to be vaccinated in the absence of any contraindications had alternative means of learning. Also, from the perspective of leisure opportunities for children in this category, the exercise of social private life was not a central aspect of their right to respect for private life.
123. As regards the necessity in a democratic society of the measures mandated by the contested provisions, the court noted that the available 2015 immunisation records for the vaccines in the immunisation schedule showed the lowest vaccination rate in ten years. This increased the risk of epidemics of communicable diseases which had been prevented for decades by vaccination, because a high level of collective immunity was needed to prevent an outbreak of an epidemic. In view of all the circumstances, including the duty of everyone to respect the public interest and not jeopardise the health of others, the court found that the criterion of necessity was fulfilled.
128. In a case concerning the vaccination of a baby placed in the care of the local authorities, notwithstanding the objections of the parents (Re H (A Child)(Parental Responsibility:Vaccination),  EWCA Civ 664), the judgment of the Court of Appeal of 22 May 2020 concluded as follows:
"(i) Although vaccinations are not compulsory, the scientific evidence now clearly establishes that it is in the best medical interests of children to be vaccinated in accordance with Public Health England's guidance unless there is a specific contraindication in an individual case.
(ii) Under [the applicable statutory provision] a local authority with a care order can arrange and consent to a child in its care being vaccinated where it is satisfied that it is in the best interests of that individual child, notwithstanding the objections of parents.
(iii) The administration of standard or routine vaccinations cannot be regarded as being a 'serious' or 'grave' matter. Except where there are significant features which suggest that, unusually, it may not be in the best interests of a child to be vaccinated, it is neither necessary nor appropriate for a local authority to refer the matter to the High Court in every case where a parent opposes the proposed vaccination of their child. To do so involves the expenditure of scarce time and resources by the local authority, the unnecessary instruction of expert medical evidence and the use of High Court time which could be better spent dealing with one of the urgent and serious matters which are always awaiting determination in the Family Division.
(iv) Parental views regarding immunisation must always be taken into account but the matter is not to be determined by the strength of the parental view unless the view has a real bearing on the child's welfare."
1.International Covenant on Economic, Social and Cultural Rights
131. In its Concluding observations as part of the periodic review of individual States, the UN Committee on Economic, Social and Cultural Rights has repeatedly emphasised the duty of preventive vaccination of the highest possible percentage of the population (see, for example, observations of 7 June 2010 on Kazakhstan (E/C.12/KAZ/CO/1), § 4). It has also criticised a decreased rate of vaccination (see, for example, observations of 13 December 2013 on Egypt (E/C.12/EGY/CO/2-4), § 21) and called for a reversal of that negative trend (see, for example, observations of 13 June 2014 on Ukraine (E/C.12/UKR/CO/6), § 19).
3.Documents of the World Health Organisation (WHO)
135. In its "Global Vaccine Action Plan" published in 2013 the WHO recommended attaining a national coverage rate of at least 90% in relation to all vaccines that form part of national immunisation programmes. As regards vaccination in general, it made the following observations:
"Overwhelming evidence demonstrates the benefits of immunisation as one of the most successful and cost-effective health interventions known. Over the past several decades, immunization has achieved many things, including the eradication of smallpox, an accomplishment that has been called one of humanity's greatest triumphs. Vaccines have saved countless lives, lowered the global incidence of polio by 99 percent and reduced illness, disability and death from diphtheria, tetanus, whooping cough, measles, Haemophilus influenzae type b disease, and epidemic meningococcal A meningitis.
The last century was, in many respects, the century of treatment, resulting in dramatic reductions in morbidity and mortality, with the discovery and use of antibiotics as one of the biggest agents of change in health. This century promises to be the century of vaccines, with the potential to eradicate, eliminate or control a number of serious, life-threatening or debilitating infectious diseases, and with immunization at the core of preventive strategies."
Mr. Mehta submitted that in Vavřička the ECHR had also heard an anti-vaccination group to emphasis that both sides of the arguments were presented before it.
"231. The intervening association represents patients who suffer from health problems as a result of having been vaccinated. On that basis it described the situations of children who had not been vaccinated at all or were not in full compliance with the applicable vaccination schedule. Those situations mostly involved the children not being admitted to nursery schools, the mother losing her job as she was left with no alternative but to stay at home with her child and the family losing a source of income. Nonetheless, those families would rather change their lifestyle than expose their children to the risks inherent in vaccination.
265. To determine whether this interference entailed a violation of Article 8 of the Convention, the Court must examine whether it was justified under the second paragraph of that Article, that is, whether the interference was "in accordance with the law", pursued one or more of the legitimate aims specified therein, and to that end was "necessary in a democratic society"."
Accordingly, Mr. Mehta submitted that two tests were formulated by the ECHR to determine the validity of the vaccine mandates -
He further quoted -
"266. The Court reiterates that an impugned interference must have some basis in domestic law, which law must be adequately accessible and be formulated with sufficient precision to enable those to whom it applies to regulate their conduct and, if need be with appropriate advice, to foresee, to a degree that is reasonable in the circumstances, the consequences which a given action may entail (see, for example, Dubská and Krejzová v. the Czech Republic [GC], nos. 28859/11 and 28473/12, § 167, 15 November 2016, with a further reference)."
273. The applicable principles may be summarised as follows (see, in particular, Dubská and Krejzová, cited above, §§ 174-8, with further references):
An interference will be considered "necessary in a democratic society" for the achievement of a legitimate aim if it answers a "pressing social need" and, in particular, if the reasons adduced by the national authorities to justify it are "relevant and sufficient" and if it is proportionate to the legitimate aim pursued.
274. The Court has held that matters of healthcare policy are in principle within the margin of appreciation of the domestic authorities, who are best placed to assess priorities, use of resources and social needs (see Hristozov and Others v. Bulgaria (nos. 47039/11 and 358/12, § 119, ECHR 2012 (extracts), with further references).
279. As submitted by the respondent Government, it should also be seen as encompassing the value of social solidarity, the purpose of the duty being to protect the health of all members of society, particularly those who are especially vulnerable with respect to certain diseases and on whose behalf the remainder of the population is asked to assume a minimum risk in the form of vaccination (see in this respect Resolution 1845(2011) of the Parliamentary Assembly of the Council of Europe, set out at paragraph 143 above)...
293. While vaccination is a legal duty in the respondent State, the Court reiterates that compliance with it cannot be directly imposed, in the sense that there is no provision allowing for vaccination to be forcibly administered. In common with the arrangements made in the intervening States, the duty is enforced indirectly through the application of sanctions. In the Czech Republic, the sanction can be regarded as relatively moderate, consisting of an administrative fine that may only be imposed once. In Mr Vavřička's case, while he argued that the fine was high for him in the circumstances (see paragraph 162 above), the Court notes that the amount was towards the lower end of the relevant scale, and cannot be considered as unduly harsh or onerous.
300. As for the effectiveness of vaccination, the Court refers once again to the general consensus over the vital importance of this means of protecting populations against diseases that may have severe effects on individual health, and that, in the case of serious outbreaks, may cause disruption to society (see paragraph 135 above).
301. With regard to safety, it is not disputed that although entirely safe for the great majority of recipients, in rare cases vaccination may prove to be harmful to an individual, causing serious and lasting damage to his or her health. Complaints in relation to such situations have been the subject of previous proceedings under the Convention (see, in particular, Association of Parents v. the United Kingdom, no. 7154/75, Commission decision of 12 July 1978, DR 14, p. 31; and Baytüre and Others, cited above, § 28). At the oral hearing in the present case, the Government indicated that out of approximately 100,000 children vaccinated annually in the Czech Republic (representing 300,000 vaccinations), the number of cases of serious, potentially lifelong, damage to health stood at five or six. In view of this very rare but undoubtedly very serious risk to the health of an individual, the Convention organs have stressed the importance of taking the necessary precautions before vaccination (see Solomakhin, cited above, § 36; Baytüre and Others, cited above, § 29, and Association of Parents, cited above, pp. 33-34). This evidently refers to checking in each individual case for possible contraindications. It also refers to monitoring the safety of the vaccines in use. In each of these respects the Court sees no reason to question the adequacy of the domestic system. Vaccination is performed by medical professionals only if there is no contraindication, which is checked beforehand as a matter of routine protocol. Vaccines are subject to registration by the State Agency for Drug Control, with all healthcare professionals concerned being under a specific duty to report any suspicion of serious or unexpected side-effects (see paragraphs 78 and 79 above). Accordingly, the safety of the vaccines in use remains under continuous monitoring by the competent authorities."
Thereafter, Mr. Mehta relied on Novak Djokovic v. Minister for Immigration, Citizenship, Migrant Services and Multicultural Affairs, wherein the Federal Court of Australia held that the Minister for Immigration had validly made a decision based on statutory schemes to cancel the visa of Novak Djokovic, who was not vaccinated. Mr. Mehta argued that the Federal Court had noted that being a public figure Mr. Djokovic's stance on vaccination had created an adverse public perception, which, Mr. Mehta stated, was argued to act as an hindrance to the efforts of the Government encouraging more and more people to get vaccinated.
"78. The central proposition of Mr Djokovic's argument was that the Minister lacked any evidence and cited none that his presence may "foster anti-vaccination sentiment". There was no evidence, it was submitted, that he had urged people not to be vaccinated. Nor was there any evidence that in the past his circumstances had fostered such a sentiment in other countries.
79. However, it was open to infer that it was perceived by the public that Mr Djokovic was not in favour of vaccinations. It was known or at least perceived by the public that he had chosen not to be vaccinated. There was material (in Attachment H) before the Minister and to which he referred in the reasons that anti-vaccination groups had portrayed Mr Djokovic as a hero and an icon of freedom of choice in relation to being vaccinated.
Mr. Mehta also referred to the judgment of the Supreme Court of New South Wales in Kassam v. Hazzard. Therein the Supreme Court had found against the petitioner who had challenged the vaccine mandate.
"1.The highly contagious variant of COVID-19 known as the Delta variant was first detected in the community in New South Wales in June 2021. Since that time, it has spread rapidly. In response to the threat to public health it poses, the Minister for Health and Medical Research, the Honourable Bradley Hazzard, (the "Minister"), made various orders under s 7(2) of the Public Health Act 2010 (the "PHA") which on any view significantly affect the freedoms of the citizens of this State and impose greater burdens on those who are not vaccinated. The main focus of the two proceedings the subject of this judgment is those aspects of those orders which prevented so called "authorised workers" from leaving an affected "area of concern" that they resided in, and prevent some people from working in the construction, aged care and education sectors, unless they have been vaccinated with one of the approved COVID-19 vaccines.
7. Leaving aside the constitutional challenge raised by the Kassam plaintiffs, in considering the grounds of challenge raised in both proceedings it is important to note that it is not the Court's function to determine the merits of the exercise of the power by the Minister to make the impugned orders, much less for the Court to choose between plausible responses to the risks to the public health posed by the Delta variant. It is also not the Court's function to conclusively determine the effectiveness of some of the alleged treatments for those infected or the effectiveness of COVID-19 vaccines especially their capacity to inhibit the spread of the disease. These are all matters of merits, policy and fact for the decision maker and not the Court (see Minister for Immigration and Citizenship v Li (2013) 249 CLR 332;  HCA 18 at ,  and ; "Li"). Instead, the Court's only function is to determine the legal validity of the impugned orders which includes considering whether it has been shown that no Minister acting reasonably could have considered them necessary to deal with the identified risk to public health and its possible consequences.
8. As explained below, one of the main grounds of challenge in both cases concerns the effect of the impugned orders on the rights and freedoms of those persons who chose not be vaccinated especially their "freedom" or "right" to their own bodily integrity…
10. Further, any consideration of the unreasonableness of an order made under s 7(2) is to be undertaken by reference to the objects of the PHA which are exclusively directed to public safety. Orders and directions under the PHA that interfere with freedom of movement but differentiate between individuals on arbitrary grounds unrelated to the relevant risk to public health, such as on the basis of race, gender or the mere holding of a political opinion, would be at severe risk of being held to be invalid as unreasonable(see Li at  per Hayne, Kiefel and Bell JJ). However, the differential treatment of people according to their vaccination status is not arbitrary. Instead, it applies a discrimen, namely vaccination status, that on the evidence and the approach taken by the Minister is very much consistent with the objects of the PHA. Accordingly, for this reason and the reasons set out below this aspect of both challenges fails.
Thereafter, Mr. Mehta referred to the findings of the Court -
"204. Second, even if being unvaccinated satisfies the definition of disability, then the differential treatment of people who are not vaccinated may not amount to direct discrimination because it appears that such people are not being treated less favourable "in circumstances that are not materially different" to the vaccinated (s 5(1) and 5(2)). There is a material difference between being a person who is vaccinated and a person who is unvaccinated, namely, the degree of transmission threat they represent to others. Similarly, the definition of indirect discrimination is qualified by a provision that stipulates that any requirement or condition imposed on an aggrieved person that "is reasonable, having regard to the circumstances of the case" is not discrimination (s 6(3)).
232. The starting point for addressing an argument based on unreasonableness is the construction of the statute. Ultimately, the ground is addressed to whether the statutory power has been abused (Li at  per Hayne, Kiefel and Bell JJ). The scope, purpose and construction of s 7(2) has already been addressed. In terms of the statute, the question is whether it has been shown that no Minister acting reasonably could have considered it necessary, that is appropriate and adapted, to deal with the identified risk to public health and its possible consequences by making the impugned orders (see ).
235. Two other aspects of the standard of unreasonableness that have already been touched upon should be noted. The first are the very large constraints operating upon a court in arriving at a conclusion of unreasonableness especially in the present context. The judgment in Li concerned an unreasonable failure by a tribunal to grant an adjournment, a decision and context with which the Courts are familiar. The present context concerns the formulation of general rules dealing with a risk to public health and its possible consequences, a decision and context with the Courts are not familiar and which is very much "informed by considerations of policy" (Li at  per Gageler J). In such contexts there is "generally an area of decisional freedom" which is large (Li at  per French CJ and at  per Hayne, Kiefel and Bell JJ). The Courts role is not to review the "merits" and substitute its own decision (Li at ) or make its own assessment of what is reasonable (Stretton at  per Allsop CJ).
239. Particulars (a) and (b) of ground 3 refer to "scientific certainty" about the safety and efficacy of the COVID-19 vaccines in relation to the disease including the Delta variant. If that is meant to convey absolute certainty, then I agree that there is no absolute certainty on those topics and doubt that there ever could be. Professor Macartney agreed that there was not "absolute certainty" regarding the efficacy of the COVID-19 vaccines in dealing with the Delta variant but concluded that "there's quite a degree of certainty around the effectiveness of the vaccines against the Delta variant".  She agreed that there is "some level of uncertainty" about the safety of the vaccines but added that since the clinical trials there has been "an enormous body of safety data" while adding that observation of the safety of the vaccines would continue.  As for particular (c), the range of reasonable methods of "deal[ing]" with the identified "risk and its possible consequences" is extremely wide given the multitude of policy considerations at play.
Mr. Mehta informed the Bench that the said judgment was upheld by the Court of Appeal, but he sought time to find out if the same had attained finality.
He referred to a decision of the Constitutional Council of France, the highest constitutional authority in France. In Decision No. 2021-824 DC of 5 August 2021 of Constitutional Council of France, it had upheld the validity of the requirement of "health pass" to access department stores, shopping centres and public transport.
"36. The disputed provisions provide that the Prime Minister may make public access to certain places, establishments, services or events where certain activities take place subject to the presentation of either the results of a viral screening test that do not conclude that a person is infected with Covid-19, proof of vaccination status with regard to Covid-19, or a certificate of recovery following infection with Covid-19. They also provide that, from 30 August 2021, such a measure may be made applicable to persons who intervene in such places, establishments, services or events.
37. These provisions, which are likely to restrict access to certain places, infringe the freedom of movement and they are likely to restrict the freedom of assembly, and the right of collective expression of ideas and opinions.
38. However, firstly, the legislator considered that, in the light of the scientific knowledge available to them, the risks of circulation of the Covid-19 virus are greatly reduced between people who have been vaccinated, recovered or who have just undergone a screening test with negative results. By adopting the disputed provisions, the legislator sought to allow public powers to take measures to limit the spread of the Covid-19 epidemic. As such, the legislator has pursued the objective of constitutional value of the protection of health.
39. Secondly, these measures can only be imposed for the period from the entry into force of the law referred for review until 15 November 2021, a period during which the legislator considered that there was a significant risk of the epidemic spreading because of the appearance of new variants of the virus that were more contagious. For the reasons mentioned in paragraph 29, this assessment is not, to current knowledge, clearly inadequate concerning the current context.
40. Thirdly, the disputed measures may apply in certain places, establishments, services or events where leisure, commercial dining or drinking activities are carried out. They may also apply to trade fairs, seminars and trade shows, health, social and medico-social services and establishments, long-distance travel by inter-regional public transport and certain department stores and shopping centres.
41. On the one hand, by providing for the application of these measures to trade fairs, seminars and trade shows, to long-distance travel by inter-regional public transport and to department stores and shopping centres, the legislator has reserved their application to activities which bring together a large number of people in the same place and thus present an increased risk of transmission of the virus. Similarly, by providing for the application of these same measures to health, social and medico-social services and establishments, as well as to leisure, catering and drinking establishments, with the exception of collective dining, take-away sales of prepared meals and professional catering on roads and railways, the legislator has limited their application to places where the activity carried out presents, by its very nature, a particular risk of spreading the virus.
48. It follows from the foregoing that the disputed provisions form a balanced reconciliation between the above-mentioned constitutional requirements."
Finally, he relied on Amalgamated Transit Union Local 113 (ATU) v. Toronto Transit Commission (TTC), wherein the Superior Court of Justice, Ontario had denied the request made by ATU to suspend the operation of the mandatory vaccination policy imposed by TTC.
" This raises squarely a consideration that also arises in the context of the analysis of the irreparable harm branch of the test for interim injunctive relief. NOWU argues that the vaccination policy is coercive, and the employees who get vaccinated against their wishes will be irreparably harmed through violations of informed consent to medical treatment and bodily autonomy, and the reasonable probability of personal injury arising from the vaccine. In the context of the jurisdictional argument, this harm is alleged to render the arbitration moot if enforcement of the policy is not enjoined.
 I conclude I must assume that the City and local public health authorities give public health guidance and advice in the public interest, especially in a pandemic. I see no principled reason why the deference I would accord to the policies pronounced by the City and local public health authorities should not be extended to the TTC, an essential service and City agency, when it promulgates policies consistent with those encouraged by the City and local public health authorities. I thus conclude that the TTC has established that the enforcement of its mandatory vaccination policy aligns with the public interest broadly, as well as the interests of the TTC's workforce and ridership specifically."
Justice Rao stated that the Superior Court of Ontario is the largest Superior Trial Court in Canada and one of the busiest trial courts handling criminal civil matters in the world.
After referring to the foreign judgments, Mr. Mehta referred to his compilation of Indian judgments based on specific propositions. The broad propositions addressed by him were -
"It is not enough that you create a doubt in the mind of the court, you have to discharge the burden. Everything is in the public domain."
"...Safety and health of the people is entrusted by the Constitution to the politically accountable officials of the States to guard and protect [Jacobson vs. Massachusetts 197 US 11, 38 (1905)]. When the State undertakes to act in areas fraught with medical and scientific uncertainties, their latitude must be especially broad. [Marshall vs. U.S. 414 US 417,427]. The Courts lack the background, competence and expertise to assess public health [Garcia vs. San Antonio Metropolitan Transit Authority 469 U.S. 528, 545 (1985)]."
"In our considered opinion the petitioners' challenge to constitutionality of the impugned amendment is bound to fail. Courts are not equipped to decide the medical issue relating to public health, as to whether compulsory iodisation should be replaced by voluntary iodisation as has been done in some developed countries, so that both common salt and iodised salt are available in the market and only those 10% who are deficient in iodine can opt for iodised salt. The Government of India has taken note of scientific and medical inputs, research results and survey data to conclude that compulsory iodisation is the most effective and accepted method for elimination of iodine deficiency disorders and that consumption of iodised salt by persons not suffering from iodine deficiency will not adversely affect them. Rule 44-I is stated to be in implementation of a policy decision regarding public health. The material placed by the petitioners is not sufficient to hold that the reason for the ban is erroneous and that Rule 44-I is unreasonable and arbitrary. We therefore reject the contention that the provision placing a ban on sale of non-iodised salt for human consumption resulting in compulsory intake of iodised salt, is arbitrary and violative of Article 14 or injurious to the health of general populace and therefore violative of Article 21. The use of common salt (non-iodised salt) for industrial and commercial use has not prohibited. The ban operates only in regard to use of common salt for human consumption. There is also no material to show that any monopoly is sought to be created in favour of a chosen few companies or MNCs. In the circumstances, the contention that Article 19(1)(g)is violated is liable to be rejected."
"In M. Vijaya v. The Chairman, Singareni Collieries and Ors. reported in AIR 2001 (AP) 502, the court, upon a detailed discussion of the competing rights of a private party and public right with reference to right to privacy of a person suspected of suffering from AIDS, held:
"There is an apparent conflict between the right to privacy of a person suspected of HIV not to submit himself forcibly for medical examination and the power and duty of the State to identify HIV infected persons for the purpose of stopping further transmission of the virus. In the interests of the general public, it is necessary for the State to identify HIV positive cases and any action taken in that regard cannot be termed as unconstitutional as under Article 47 of the Constitution, the State was under an obligation to take all steps for the improvement of the public health. A law designed to achieve this object, if fair and reasonable, in our opinion will not be in breach of Article 21 of the Constitution of India. It is well settled that right to life guaranteed under Article 21 is not mere animal existence. It is a right to enjoy all faculties of life. As a necessary corollary, right to life includes right to healthy life."
If respondent avoids such medical examination on the ground that it violates his/her right to privacy or for a matter right to personal liberty as enshrined under Article 21 of the Constitution of India, then it may in most of such cases become impossible to arrive at a conclusion. It may render the very grounds on which divorce is permissible nugatory. Therefore, when there is no right to privacy specifically conferred by Article 21 of the Constitution of India and with the extensive interpretation of the phrase "personal liberty" this right has been read into Article 21, it cannot be treated as absolute right. What is emphasized is that some limitations on this right have to be imposed and particularly where two competing interests clash. In matters of aforesaid nature where the legislature has conferred a right upon his spouse to seek divorce on such grounds, it would be the right of that spouse which comes in conflict with the so-called right to privacy of the respondent. Thus the Court has to reconcile these competing interests by balancing the interests involved.
If for arriving at the satisfaction of the Court and to protect the right of a party to the lis who may otherwise be found to be incapable of protecting his own interest, the Court passes an appropriate order, the question of such action being violative of Article 21 of the Constitution of India would not arise. The Court having regard to Article 21 of the Constitution of India must also see to it that the right of a person to defend himself must be adequately protected."
Referring to Subramanian Swamy v. Union of India, Ministry of Law And Ors., Mr. Mehta stated -
"Court has devised that there is no water tight compartment of each fundamental right. But it depends on whose fundamental right outweighs whose other fundamental right. For. example, my right to not be infected would outweigh the other's right of not being vaccinated."
The relevant portion referred to deals with the concept of fraternity in the context of the duty to respect others dignity.
"151. The term "fraternity" has a significant place in the history of constitutional law. It has, in fact, come into prominence after French Revolution. The motto of Republican France echoes:- 'Liberté, égalité, fraternité', or 'Liberty, equality, fraternity'. The term "fraternity" has an animating effect in the constitutional spectrum.
Fraternity as a concept is characteristically different from the other constitutional goals. It, as a constitutional concept, has a keen bond of sorority with other concepts.
163. We have referred to two concepts, namely, constitutional fraternity and the fundamental duty, as they constitute core constitutional values. Respect for the dignity of another is a constitutional norm. It would not amount to an overstatement if it is said that constitutional fraternity and the intrinsic value inhered in fundamental duty proclaim the constitutional assurance of mutual respect and concern for each other's dignity. The individual interest of each individual serves the collective interest and correspondingly the collective interest enhances the individual excellence. Action against the State is different than an action taken by one citizen against the other."
Alluding to the judgment of the Supreme Court in K. Puttaswamy v. Union of India, Mr. Mehta submitted that -
"Even if it is right to privacy, if there is legitimate state interest then even privacy has to give way."
The Counsels for the States that had imposed vaccine mandates are to complete their submissions tomorrow and Mr. Bhushan has sought about two hours for rebuttal. The matter to be taken up tomorrow i.e. 22nd March, 2022.
[Case Title: Jacob Puliyel v. Union of India]
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