By Gangesh Aggarwal and Sangita Sharma
Introduction
Amidst the battle against COVID-19, various states across the country are ensuring and contributing to improve the public health of their citizens. However, in doing so, the government authorities have occasionally taken excessive measures in the guise of public health improvement. One such immoderate measure is making vaccination mandatory for shop owners,[1] taxi drivers, and traders[2] by various states, in contradiction to the Central Government’s decision of making it voluntary.[3]
The recent decision of the Meghalaya High Court in Registrar General High Court of Meghalaya v. State of Meghalaya[4] where the issue pertained to the state government mandating vaccination for shopkeepers, vendors, local taxi drivers and others, clarified that compulsory or forced vaccination does not find any legal force, thus leading to the declaration of ultra vires ab initio in this kind of conduct.[5] Further, the High Court stated that compulsory use of coercive techniques vitiates the essential aim of its well-being and acknowledged that there is skepticism regarding COVID-19 vaccines all over the country.[6]
Therefore, considering the contradiction between the decision of states and the Central Government, the recent Meghalaya High Court judgment, and the fact that there is widespread skepticism about COVID-19, it is imperative to analyze the constitutional validity of such compulsory vaccination policies. This article analyzes the constitutional validity of compulsory vaccination in India and argues how such an act of the state governments violates the fundamental right to privacy and the right to informed consent enshrined under Article 21 of the Constitution while also failing the proportionality test.
Violation of Individual’s Right to Privacy
The Supreme Court in Justice (Retd) KS Puttaswamy and Ors. v. Union of India and Ors.,[7] unanimously recognized the right to privacy as an intrinsic part of the right to life and liberty under Article 21. The fundamental right to privacy covers privacy of choice which protects an individual’s self-determination concerning personal choices which are fundamental in nature.[8] The right to privacy safeguards individual autonomy as well as protects one’s autonomy in making the decisions related to one’s body.
Autonomy in the field of health and medical care is the right to receive or decline medical treatment and the patient has the right to exercise autonomy in all their medical decisions which concern their welfare and treatment.[9] Further, respect should be given to the wishes of an individual even when they unreasonably refuse to consent to their treatment[10] as every individual must have the right to accept or reject medical intervention. The Meghalaya High Court’s recent judgment also stated that the coercive element of vaccination is discouraged as well as consistently ruled against by the Courts for over more than a century.[11]
Therefore, as an individual has the fundamental right to determine what may be injected into their bodies, the State cannot force them for it and such compulsory measures will violate the fundamental right to privacy.
Violation of Individual’s Right to Informed Consent
The Hon’ble Apex Court has held that “informed consent” by an individual is a sine qua non in medical procedures and without this, no medical procedure can be resorted to.[12] Every citizen has an inherent right to receive complete information regarding public matters so that they can make an informed and rational decision.[13] Also, the Nuremberg Code[14] and the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002[15] explicitly mandate obtaining voluntary and informed consent for various medical procedures and vaccination is a medical procedure.[16]
The trials of vaccines for testing their efficacy and the possibility of side effects are done by the vaccine manufacturing companies who themselves have a commercial interest in the propagation.[17] There have been previous instances where drug manufacturers were being caught hiding or manipulating data and concealing side effects or overstating efficacy.[18] Further, it usually takes around 12 years[19] for a drug to reach the market, however, due to limited time, the COVID-19 vaccines had to be approved within one year. Merely because there exists a time constraint the quality of the product cannot be compromised. Therefore, there should be an unbiased and honest examination of the drug by independent researchers so that an informed decision can be made by the people regarding administration of the vaccine.
The Government has not disclosed the data[20] of vaccine clinical trials, when such disclosure is very crucial to ascertain whether a certain section of the population is more susceptible to adverse effects. There has been Adverse Event Following Immunisation (AEFI) that might happen in few people but reactions that are not known reactions to the vaccine are not considered to fall within the ambit of AEFI.[21] Also, public health specialists have pointed out major gaps in the investigation of AEFIs.[22] The World Health Organisation (WHO) has stated that decisions about mandatory vaccination should be based on best available data and should be made in an informed, transparent and fair manner, without discrimination, and in consultation with affected parties, an approach which the state governments have failed to undertake.[23]
A situation where people are unsure about the safety of the vaccine it is impossible for them to make an informed decision about whether they should take it or not.The Delhi High Court in Master Haridaan Kumar Minor through and Ors. v Union of India and Ors. and BabyVeda Kalaan and Ors. v Directorate of Education and Ors. held the requirement of compulsory vaccination to those children whose parents have declined to provide informed consent will violate Article 21.[24] Therefore, mandating vaccination without providing adequate information on vaccines and thereby preventing the citizens from making a decision based on informed consent is a violation of Article 21.
Proportionality Test
There exists no legal right that is absolute as every legal right is subject to certain restrictions. The doctrine of Proportionality is the set of rules that determine the necessary and sufficient grounds required for a law to be constitutionally valid to limit the constitutionally protected rights.[25] It sets forth that the extent to which a law interferes with the fundamental rights must be proportionate to the aim it seeks to achieve. The four prongs of the proportionality test are legitimate goal stage, suitability or rationale connection stage, necessity stage, and balancing stage.[26]
In the present case, the state governments have a legitimate aim to curb the spread of the virus by mandating vaccination which is in public health interest, thereby qualifying the first prong. This policy is based on the assumption that compulsory vaccination for resuming business will increase the turnout for vaccination and even though there is no concrete evidence to support that mandatory vaccine will increase the turnout for vaccination.[27] Further, the second prong of the proportionality test will be satisfied even if there is a slight connection between the interference and the legitimate goal[28] and in the present case vaccines reduce the risk of developing illness and protect people around us. As the threshold to pass rationale connection stage is very low, it is imperative to scrutinize the other prongs to analyze the constitutionality of mandating vaccines.
The most important prong to analyse in the present situation is the third prong (necessity stage). This prong is a fact-based test[29] as for this prong the court will determine the available alternatives in consonance with the intended goal of the State and correspondingly examine for the present case whether the adopted policy of compulsory vaccination is the minimal restrictive but equally operative measure to achieve the legitimate aim of public health.
It is the duty of the State to consider alternatives and in case of an omission to do so, the restriction imposed would be considered disproportionate.[30] Further, the State through “empirical data” must establish why the action taken by it was the only possible measure while no effective alternative measures could have been adopted.[31]
Initially, the State should consider less coercive measures; if those fail, then it can resort to compulsory vaccination policies. The World Health Organization has stated that the governments should encourage voluntary vaccination against the virus before contemplating mandatory vaccination.[32] It was stated that if there is a low turnout for vaccination then the concerns should be addressed proactively and if this method is ineffective only then a mandate should be considered necessary.
The state governments had to force people to get vaccinated because many people did not consent to take the vaccine.[33] Vaccine hesitancy as defined by WHO is “delay in acceptance or refusal of vaccination despite the availability of vaccination services”.[34]The cause of vaccine hesitancy is the lack of trust, fear of side-effects, misinformation, and concerns regarding safety and efficacy of the vaccines.[35] The state governments ought to figure out the cause of vaccine hesitancy and resolve it rather than coercing people into taking the vaccines. Making vaccination compulsory will not foster trust in the minds of people, but only increase hesitancy as the marginalized people believed that the system is against them.[36] The alternative available with the state governments is to disseminate and sensitize the citizens of the entire exercise of vaccination with its pros and cons through awareness campaigns, to ensure prompt, thorough and transparent investigation of AEFI,[37] financial reward, providing material assistance.
The state governments that are mandating the vaccination have neither considered the effective alternatives available suggested by World Health Organization or any other alternatives nor provided any empirical data stating why compulsory vaccination is the best possible measure available. Therefore, the mandatory vaccination policy fails to satisfy the third prong of the test.
The fourth prong requires “balancing” the competing interests at hand. The states to satisfy this prong in the present circumstances have to establish a balance between public health and the purported social limitation to the right to privacy and informed consent. The vaccines have inevitable side effects[38] and there have been many cases of adverse events and deaths.[39] Further, people with severe allergic reactions such as anaphylaxis to any component of the COVID-19 vaccine are advised against administering the vaccine.[40] The policies are also unclear on this aspect as to whether such people are allowed to refrain from taking the vaccine. The citizens who are prone to risk cannot be forced to put their life at risk and the life of some cannot be sacrificed for the purpose of the eventual larger good.[41] Mandating vaccines could potentially lead to serious adverse events to the citizens and in some cases the vaccine might possess the risk that is more severe and fatal than the effect of the virus itself, which will overshadow the public health aim, therefore the policy failing to qualify the balancing prong.
As the compulsory vaccination policy fails the proportionality test, implementing such policies will be in violation of the right to privacy and the right to informed consent enshrined under Article 21 and would constitute a disproportionate measure for limiting such fundamental rights for public health.
Conclusion
The government has itself created many barriers for its citizens to take the vaccine, such as inequitable access and lack of transparent data. Due to the widespread concerns and doubts, the use of a coercive method to force people to get the vaccinations would simply aggravate the situation and fail to boost vaccination rates. Using this opportunity to bring awareness to vaccination procedures and clear any misconceptions about them will aid in their administration naturally. There is a responsibility to ensure that vaccinations are accessible for everyone. If the government falls short on this responsibility, no citizen should be penalized for their mistakes. While promoting and ensuring public health is important, however, trying to reach such an agreement when people lack necessary healthcare and relevant knowledge is in violation of their fundamental rights.
The authors, Gangesh Aggarwal and Sangita Sharma, are undergraduate law students at the Gujarat National Law University (GNLU), Gandhinagar.
[1] Economic Times, Uttar Pradesh: Vaccination is mandatory for businessmen who are 45 years and above or else would not be allowed to open their shops, June 5, 2021, available at https://economictimes.indiatimes.com/news/india/uttar-pradesh-vaccination-is-mandatory-for-businessmen-who-are-45-years-and-above-or-else-would-not-be-allowed-to-open-their-shops/videoshow/83253586.cms (Last visited on July 23, 2021).
[2] Hindustan Times, Odisha district makes vaccination compulsory for traders, June 17, 2021, available at
https://www.hindustantimes.com/india-news/odisha-district-makes-vaccination-compulsory-for-traders-101623925757266.html (Last visited on July 23, 2021).
[3] Business Standard, No one can be forced to take Covid-19 vaccine, govt will educate: Vardhan, December 21, 2020, available at
https://www.business-standard.com/article/current-affairs/no-one-can-be-forced-to-take-covid-19-vaccine-govt-will-educate-vardhan-120122100102_1.html (Last visited on July 13, 2021).
[4] Registrar General High Court of Meghalaya v. State of Meghalaya, PIL No.6/2021 (Megh. H.C.) (Unreported).
[5] Id.
[6] Id,¶7.
[7] Justice (Retd) KS Puttaswamy and Ors. v. Union of India and Ors. AIR 2017 SC 4161.
[8] Id.
[9] Common Cause (A Regd. Society) v. Union of India (UOI) and Ors. AIR 2018 SC 1665.
[10] Aruna Ramchandra Shanbaug v. Union of India (UOI) and Ors. AIR 2011 SC 1290.
[11] Registrar General High Court of Meghalaya v. State of Meghalaya, PIL No.6/2021 (Megh. H.C.) (Unreported).
[12] Aarushi Dhasmana v. UOI &Ors. (2013) 9 SCC 475.
[13] Reserve Bank of India v. Jayantilal N. Mistry, (2016) 3SCC 525.
[14] The Nuremberg Code (1947).
[15] Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002.
[16] NCBI, Mandatory Vaccination of Health Care Workers Whose Rights Should Come First?, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2810172/ (Last visited on July 27, 2021).
[17] World Trade Organization, DEVELOPING AND DELIVERING COVID-19 VACCINES AROUND THE WORLD, December 22, 2020, available at https://www.wto.org/english/tratop_e/covid19_e/vaccine_report_e.pdf (Last visited on July 28, 2021).
[18] Drugwatch, Drug and Device Companies Gave Billions to Doctors in 2016, July 3, 2017, available at https://www.drugwatch.com/news/2017/07/03/big-pharma-influence-doctors-2016/ (Last visited on July 13, 2021).
[19] Medicine Net, Drug Approvals – From Invention to Market … A 12- Year Trip, July 14, 1999, available at https://www.medicinenet.com/script/main/art.asp?articlekey=9877 (Last visited on July 13, 2021).
[20] The Telegraph, Covid: Vaccine expert moves Supreme Court for transparency in clinical trials, June 14, 2021, available at https://www.telegraphindia.com/india/covid-vaccine-expert-moves-supreme-court-for-transparency-in-clinical-trials/cid/1815521 (Last visited on July 13, 2021).
[21] NCBI, Revised World Health Organization (WHO)’s causality assessment of adverse events following immunization—a critique, May 29, 2018, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6039921/ (Last visited on July 13, 2021).
[22] Deccan Herald, Ensure transparent probe, April 5, 2021, available at https://www.deccanherald.com/opinion/main-article/ensure-transparent-probe-970435.html (Last visited on July 23, 2021).
[23] World Health Organization, COVID-19 and mandatory vaccination: Ethical considerations and caveats Policy brief, April 13, 2021, available at https://www.who.int/publications/i/item/WHO-2019-nCoV-Policy-brief-Mandatory-vaccination-2021.1 (Last visited on July 13, 2021).
[24] Master Haridaan Kumar Minor through and Ors. v Union of India and Ors. W.P. (C) 343/2019; Baby Veda Kalaan and Ors. v. Directorate of Education and Ors. W.P. (C) 350/2019.
[25] Modern Dental College & Research Centre v. State of M.P. (2016) 7 SCC 353.
[26] Justice (Retd) KS Puttaswamy and Ors. v. Union of India and Ors. AIR 2017 SC 4161.
[27] Asset Reports, Compulsory Vaccination and Rates of Coverage Immunisation in Europe, available at http://www.asset-scienceinsociety.eu/reports/page1.html (Last visited on July 23, 2021).
[28] Kai Moller, Proportionality: Challenging the critics, Oxford University Press (2012).
[29] Indian Constitutional Law and Philosophy, Proportionality in Application – An Analysis of the “Least Restrictive Measure”, May 8, 2020, available at https://indconlawphil.wordpress.com/2020/05/08/guest-post-proportionality-in-application-an-analysis-of-the-least-restrictive-measure/ (Last visited on July 28, 2021).
[30] Internet and Mobile Association of India v. Reserve Bank of India (2020) 10 SCC 274.
[31] Id.
[32] World Health Organization, COVID-19 and mandatory vaccination: Ethical considerations and caveats Policy brief, April 13, 2021, available at https://www.who.int/publications/i/item/WHO-2019-nCoV-Policy-brief-Mandatory-vaccination-2021.1 (Last visited on July 13, 2021).
[33] Indian Express, India has a vaccine hesitancy challenge, July 4, 2021, available at https://indianexpress.com/article/opinion/india-has-a-vaccine-hesitancy-challenge-7388907 (Last visited on July 23, 2021).
[34] Id.
[35] Id.
[36] The Wire, Misinformation Alone Can’t Explain Vaccine Hesitancy Among India’s Marginalised, June 29, 2021, available at https://science.thewire.in/health/vaccine-hesitancy-among-indias-marginalised-isnt-just-a-misinformation-issue/ (Last visited on July 22, 2021).
[37] Scroll, Compulsory Covid-19 vaccination won’t help – coercion will increase hesitancy, not reduce it, April 7, 2021, available at https://scroll.in/article/991630/compulsory-covid-19-vaccination-wont-help-coercion-will-increase-hesitancy-not-reduce-it (Last visited on July 22, 2021).
[38] World Health Organization, Coronavirus disease (COVID-19): Vaccines safety, February 9, 2021, available at
https://www.who.int/news-room/q-a-detail/coronavirus-disease-(covid-19)-vaccines-safety (Last visited June 14,
2021).
[39] News 18, 26k Adverse Events, 488 Deaths Reported in India During Covid Vaccination Drive: Data, June 14, 2021, available at
drive-data-3845363.html (Last visited June 14, 2021).
[40] World Health Organization, Clarification on the COVID-19 Vaccine Allergies, March 15, 2021, available at https://www.afro.who.int/news/clarification-covid-19-vaccine-allergies (Last visited on July 13, 2021).
[41] G. Sundarrajan v. Union of India (UOI) and Ors. (2013) 6 SCC 620.
The Journal of Indian Law and Society 