Vaccines Archives

COVID-19| No individual can be forced to be vaccinated; holds Supreme Court. Restrictions on unvaccinated persons to be revised for now

Supreme Court: In a landmark ruling on COVID-19 vaccination drive, the bench of L. Nageswara Rao* and BR Gavai, JJ has held that bodily integrity is protected under Article 21 of the Constitution of India and no individual can be forced to be vaccinated.

The Court, however, cautioned that,

“This judgment is not to be construed as impeding, in any manner, the lawful exercise of power by the executive to take suitable measures for prevention of infection and transmission of the virus in public interest, which may also take the form of restrictions on unvaccinated people in the future, if the situation so warrants. Such restrictions will be subject to constitutional scrutiny to examine if they meet the threefold requirement for intrusion into rights of individuals.”

The ruling came in the writ petition wherein the Petitioner highlighted the adverse consequences of emergency approval of vaccines in India, the need for transparency in publishing segregated clinical trial data of vaccines, the need for disclosure of clinical data, lack of transparency in regulatory approvals, minutes and constitution of the expert bodies, imperfect evaluation of Adverse Events Following Immunisation (AEFIs) and vaccine mandates in the absence of informed consent being unconstitutional. The Petitioner further stated in the Writ Petition that coercive vaccination would result in interfering with the principle of informed self-determination of individuals, protected by Article 21 of the Constitution of India.

Is the Vaccination Drive Arbitrary?

On the basis of substantial material reflecting the near-unanimous views of experts on the benefits of vaccination in addressing severe disease from the infection, reduction in oxygen requirement, hospital and ICU admissions, mortality and stopping new variants from emerging, the Court was satisfied that the current vaccination policy of the Union of India is informed by relevant considerations and cannot be said to be unreasonable or manifestly arbitrary.

Personal autonomy and public health

Bodily integrity is protected under Article 21 of the Constitution of India and no individual can be forced to be vaccinated.
Personal autonomy of an individual involves the right of an individual to determine how they should live their own life, which consequently encompasses the right to refuse to undergo any medical treatment in the sphere of individual health.
Persons who are keen to not be vaccinated on account of personal beliefs or preferences, can avoid vaccination, without anyone physically compelling them to be vaccinated. However, if there is a likelihood of such individuals spreading the infection to other people or contributing to mutation of the virus or burdening of the public health infrastructure, thereby affecting communitarian health at large, protection of which is undoubtedly a legitimate State aim of paramount significance in this collective battle against the pandemic, the Government can regulate such public health concerns by imposing certain limitations on individual rights that are reasonable and proportionate to the object sought to be fulfilled.

Restrictions on unvaccinated persons and impeding their right to access public resources

Neither the Union of India nor the State Governments produced any material to justify the discriminatory treatment of unvaccinated individuals in public places by imposition of vaccine mandates.

“No doubt that when COVID-19 vaccines came into the picture, they were expected to address, and were indeed found to be successful in dealing with, the risk of infection from the variants in circulation at the time. However, with the virus mutating, we have seen more potent variants surface which have broken through the vaccination barrier to some extent.”

Hence, the restrictions on unvaccinated individuals imposed through vaccine mandates cannot be considered to be proportionate, especially since both vaccinated and unvaccinated individuals presently appear to be susceptible to transmission of the virus at similar levels.

It has, hence, been directed that till the infection rate and spread remains low, as it is currently, and any new development or research finding comes to light which provides the Government due justification to impose reasonable and proportionate restrictions on the rights of unvaccinated individuals in furtherance of the continuing efforts to combat this pandemic, all authorities in the country, including private organisations and educational institutions, should review the relevant orders and instructions imposing restrictions on unvaccinated individuals in terms of access to public places, services and resources.

Non-disclosure of segregated clinical trial data in public domain

The results of Phase III clinical trials of the vaccines in question have been published, in line with the requirement under the statutory regime in place, the GCP guidelines and the WHO Statement on Clinical Trials. The material provided by the Union of India, comprising of minutes of the meetings of the SEC, do not warrant the conclusion that restricted emergency use approvals had been granted to COVISHIELD and COVAXIN in haste, without thorough review of the relevant data. Relevant information relating to the meetings of the SEC and the NTAGI are available in public domain and therefore, challenge to the procedures adopted by the bodies while granting regulatory approval to the vaccines on the ground of lack of transparency cannot be entertained.

However, subject to the protection of privacy of individual subjects and to the extent permissible by the 2019 Rules, the relevant data which is required to be published under the statutory regime and the WHO Statement on Clinical Trials shall be made available to the public without undue delay, with respect to the ongoing post-marketing trials of COVAXIN and COVISHIELD as well as ongoing clinical trials or trials that may be conducted subsequently for approval of other COVID19 vaccines / vaccine candidates.

Monitoring of Adverse Events Following Immunisation (AEFIs)

The Court refused to accept the sweeping challenge to the monitoring system of AEFIs being faulty and not reflecting accurate figures of those with severe reactions or deaths from vaccines.

“The role of the Pharmacovigilance Programme of India and the CDSCO, as elaborated upon by the Union of India, collates and studies previously unknown reactions seen during monitoring of AEFIs at the time of vaccine administration and we trust the Union of India to ensure that this leg of the AEFI surveillance system is not compromised with, while meeting the requirements of the rapid review and assessment system followed at the national level for AEFIs.”

Information relating to adverse effects following immunisation

Information relating to adverse effects following immunisation is crucial for creating awareness around vaccines and their efficacy, apart from being instrumental in further scientific studies around the pandemic.

Recognising the imperative need for collection of requisite data of adverse events and wider participation in terms of reporting, the Union of India has been directed to facilitate reporting of suspected adverse events by individuals and private doctors on an accessible virtual platform. These reports shall be made publicly accessible, without compromising on protecting the confidentiality of the persons reporting, with all necessary steps to create awareness of the existence of such a platform and of the information required to navigate the platform to be undertaken by the Union of India at the earliest.

Paediatric vaccination

The decision taken by the Union of India to vaccinate children in India is in tune with global scientific consensus and expert bodies like the WHO, the UNICEF and the CDC and it is beyond the scope of review for this Court to second-guess expert opinion, on the basis of which the Government has drawn up its policy.

Keeping in line with the WHO Statement on Clinical Trials and the extant statutory regime, the Court directed the Union of India to ensure that key findings and results of the relevant phases of clinical trials of vaccines already approved by the regulatory authorities for administration to children, be made public at the earliest, if not already done.

[Jacob Puliyel v. Union of India, 2022 SCC OnLine SC 533, decided on 02.05.2022]

*Judgment by: Justice L. Nageswara Rao

Counsels

For Petitioner: Advocate Prashant Bhushan,

For UOI: Solicitor General Tushar Mehta

For Respondent No. 4: Senior Advocate S. Guru Krishnakumar

For Tamil Nadu: Additional Advocate General Amit Anand Tiwari

For Maharashtra: Advocate Rahul Chitnis

For Madhya Pradesh: Advocate Mrinal Gopal Elker,

For Respondent no. 5: Advocate Shyel Trehan

Case Briefs High Courts

MP HC | Global tender issued by the different State Governments have failed to yield in positive result, Centre should take responsibility; Court continues hearing petitions regarding Black Fungus, Remdesivir, Vaccination etc

Madhya Pradesh High Court: The Divison Bench of Mohammad Rafiq, CJ. and Atul Sreedharan, J., heard and decided on a series of interlocutory applications which were filed with different prayers all in relation with COVID 19.

The prayers in these petitions included:

for an appropriate direction to the respondent/State to ensure availability of required medicines for treatment of Black Fungus (Mucormycosis) and to control cost of such treatment.
for direction to the State Government to install CT-Scan and MRI machine in Medical College/District Hospital, Ratlam. These applications were disposed of with liberty to the applicants to give suggestions at the time of hearing of the aforesaid application.
praying that the applicant was given time-slot for vaccination, but no such vaccine was provided to her. In this regard, she made complaint and the Court in this regard directed that upon the applicant/intervener approaching the Chief Medical and Health Officer, Jabalpur, he shall ensure that time slot is provided to her for the purpose of vaccination and she is vaccinated.
prayer that the State Government be directed to also provide the cost of medicines for treatment under the Ayushman Bharat Nirmayan Yojna for treatment of the persons covered in that scheme.
for a direction to the State Government to take appropriate action against the erring persons for selling fake Remdesivir and other spurious drugs for committing offences of murder under Section 302 of the Indian Penal Code, apart from those under National Disaster Management Act, Epidemic Diseases Act, 1897 and the Drugs and Cosmetic Act, 1940, he further prayed the affected persons or in case of death, the family members of the deceased, be granted adequate compensation as per provision of Section 27 of the Drugs and Cosmetic Act, 1940.

The Court in this regard opined that no such specific direction can be issued by this Court while dealing the matter under the scope of PIL. It is always for the Investigating Officer to find out on the basis of evidence collected by him during the course of investigation as to what offence is made out and accordingly submit the chargesheet. If and when the chargesheet is submitted, the Court concerned will have the occasion to examine whether or not such offences are prima facie made out for proceeding further in the trial or any other offence is made out on the basis of evidence collected by the Investigator.

prayer to issue direction to the State Government to lodge an FIR in the matter of death of five persons due to shortage of oxygen in the Galaxy Super Speciality Hospital, Jabalpur in accordance with the findings recorded in the Magisterial Enquiry conducted in the matter. Advocate General submitted that the FIR had already been lodged and the investigation was going on, in this view the Court did not deem fit to pass any order.
prayer for quashing of the order dated 20-5-2021 passed by the Collector, Indore by which a complete lockdown has been imposed in the Indore city and supply of all the essential items had been stalled. The Court opined that Collector, Indore should review his order and ensure just and equitable method of having all grocery shops, daily need shops, fruits and vegetable vendors, open during specified hours of five days a week so that neither the residents of Indore city nor the small vendors face any hardship.
the State Government should be required to demonstrate its preparedness to deal with the apprehended third wave of Covid-19 and submit the time frame and action plan to vaccinate the entire population of the State.
A prayer invited attention of the Court that the State Government has not taken any effective measures regarding fixation of the maximum rates for treatment of the Covid patients in various Private Hospitals/Nursing Homes by indicating capping of the such charges, in compliance of the order passed by this Court on 19-4-2021.

Amicus Curiae submitted that pursuant to the order passed by this Court on 19-5-2021, he had interaction with the representatives of the Indian Medical Association and M.P. Nursing Homes Association. According to him, the discussions resulted into fruitful suggestions. They are ready to make addition of 40% as directed by the State Government in its order dated 4-9-2020, invoking its power under the National Disaster Management Act and Epidemic Diseases Act, on the charges reflected in the bills of various kind of the treatments and facilities provided by them (private hospitals/nursing homes) in the month of January and February 2020 immediately before the start of the pandemic. The Court opined that , the package method of charging has to be discouraged and the suggestion which has emerged in the deliberations made by the learned Amicus Curiae with the representatives of the Indian Medical Association and M.P. Nursing Homes Association that charge for the various kind of treatments and facilities being provided by the nursing homes and private hospitals in the months of January and February, 2020 may form basis of adding 40% thereto, to fix outer limit capping of charges taken for treatment of Covid 19 patient which appears to be reasonable criteria and would be beneficial to the public at large and save them of undue exploitation.

Prayer that direction be issued to the State Government to declare Black Fungus (Mucormycosis) as “notified infectious disease” and that State Government be directed to regulate supply and cost of Amphotericin-B injections and any other medicines that would be required to treatment of Mucormycosis, so that patients and their families are not exploited.

The Court in this regard impressed upon the State Government to effective take steps so as to save the life of more than 1000 patients who are infected and many more who might be infected during the course of time. In regard to vaccination the Court opined that since as per Action Taken Report filed today by the State Government, tender has not been issued so far, the State Government may consider suitably increasing the number of doses for procurement through the global tender based on the actual requirement, particularly when each person is required to be given two doses for complete vaccination.

From the submissions made the Court concluded that the State Government has not received even half of the promised quantity of the vaccination doses for the month of May 2021, either from the Central Government for the age group of 45 and above or even from two major manufacturers within the country in response to orders placed with them. The global tender issued by the different State Governments have also failed to yield in positive result.

The Court further opined that the Central Government ought to reconsider efficacy of its vaccination policy. The Central Government should consider taking upon itself the responsibility of providing required number of vaccination doses to the State by setting up more and more units in all the States with required licence from the local manufacturers, to ramp up the production of the vaccination on war footing. Additionally, the Central Government should by itself consider procuring the vaccination doses in sufficient quantity from the manufacturers from outside the country to provide the same to the States, rather than leaving it upon the States to do so. The Central Government should also consider procuring the medicine Amphotericin-B or any other equivalent medicine by setting up more number of manufacturing unit within the country or from outside the country wherever, they may be available for immediately treatment for saving hundreds of precious lives of the citizens.

A detailed affidavit/Action Taken Report regarding the preparedness of the State Government for apprehended third wave of Covid-19 to come up on 31-05-2021.

[In Reference (Suo Motu) v. Union of India, 2021 SCC OnLine MP 963, decided on 24-05-2021]

Suchita Shukla, Editorial Assistant has put this report together

Appearance:

For petitioner: Mr. Siddharth Gupta

Amicus curiae: Mr Naman Nagrath, Senior Advocate with Mr Jubin Prasad, Advocate a

For Respondents: Mr Purushaindra Kaurav, Advocate General, Mr Pushpendra Yadav, Additional Advocate General and Mr Swapnil Ganguly, Deputy Advocate General, Mr Jitendra Kumar Jain, Assistant Solicitor General and Mr Vikram Singh, Advocate for the Union of India, Mr Shivendra Pandey, Advocate, Mr Shreyas Pandit, Advocate, Mr A.M. Mathur, Senior Advocate assisted by Mr Abhinav P. Dhanodkar, Advocate.