Case BriefsSupreme Court

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

  1. Bodily integrity is protected under Article 21 of the Constitution of India and no individual can be forced to be vaccinated.
  2. 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.
  3. 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

Experts CornerMurali Neelakantan

Following Justice Bhat and Dr Swaminathan was always going to be tough but it is even more daunting given that I am on a panel with doctors.

I am delighted to be here but I suspect that I have been the beneficiary of some nepotism having been a student here at NLSIU many, many years ago.

What you will hear over the next 15 minutes was not what I had prepared last week or two weeks ago. Dr Milind Antani casually remarked yesterday that a keynote address is expected to address the topic from 30,000 ft. I therefore have mixed feelings about my debut keynote address.

Now that I have set the expectations low, I will turn to the topic of clinical trials in India and specifically the New Drugs and Clinical Trial Rules, 2019 (‘New CT Rules’).

 

It is not that India did not have clinical trial rules before 2019. There was a whole schedule in the Drugs Rules and clinical trials were conducted in India. Several clinical research outsourcing organisations (sounds like BPO and you would not be wrong in thinking of them in that way), including global ones were active in India with thousands of applications for trials.

 

But in 2012, to quote Bob Dylan, “too many people had died”. In 2013, the Supreme Court[1] put a hold on 162 clinical trials[2]. At the same time, the Parliamentary Standing Committee scrutinised the working of the drug regulator and its report was scathing in its criticism of how drugs had been approved in India[3].

 

The Government, as expected, set up a committee, the Ranjit Roy Chaudhury Committee, to revise the clinical trial rules. The Committee consulted extensively and the current rules were a result of that process.

 

The New CT Rules incorporate the World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, 1964 as amended in 2013 (Helsinki Declaration)[4]. The two fundamental ideas underpinning the declaration, as I see it, were science and ethics.

 

There was an acknowledgement that decisions will be taken on the basis of science. Clinical trials are essentially scientific studies and the results will be evidence and facts. The New CT Rules lay out a logical and methodical procedure, as one would expect from science. These rules assume that everyone in the ecosystem making a decision will be led by science, evidence and facts. Science, evidence and facts are universal, are not they? So all is well, isn’t it? Well, those of you who have been studying jurisprudence will find this exercise interesting – Did the new rules change the behaviour and culture of the drug regulator tasked with implementing the rules, of the sponsors of the clinical trials or of the doctors conducting the trials? Dinesh Thakur will be addressing the role of the regulator in greater detail but “lipstick on a pig” should bookmark the idea in your head until he speaks and expands on Dr Swaminathan’s thought of the cycle of panic and neglect.

 

There was a recognition in the Helsinki Declaration that progress in medical science required clinical trials but also that these ought to be conducted in an ethical manner. At the heart of this was the relationship between doctor and patient, not a scientist and a specimen, not a lab technician and a Guinea pig.

 

There have been three noble professions – priests, doctors and lawyers. Do not take my word for it – look at the law. These three professions traditionally enjoy privilege. So, what is said to a priest in confession, to a doctor or a lawyer is secret. Perhaps there is a need to have a safe place, a safe relationship to keep some unpleasant truths from society.

 

I know some smart alec is itching to ask why spouses enjoy privilege and what is noble about marriage. After almost 20 years, I am ashamed to say that I do not know.

 

I think of noble professions as requiring a higher standard of ethics and integrity than the wider society to which we belong. The sorry saga of clinical trials in India can be attributed to doctors failing in their duties to their patients. Those who participate in clinical trials are referred to as “volunteers” and their doctors are referred to as “investigators”. That should give you a hint of what is to come and what the consequences are.

 

Patients are often desperate and vulnerable, and rely entirely on the doctor for advice, especially in India. They believe that the doctor is acting in their best interest at all times. This is what the Helsinki Declaration expects. Patients trust doctors like they trust God. But, as Richard Feynman, the Nobel prize winning physicist said, “Religion is a culture of faith; science is a culture of doubt.” Sadly, the less said about the ethics and integrity of babajis and godmen the better and doctors seem to be giving babajis a run for their money these days. I will not say anything about lawyers for fear that it may incriminate me.

 

Since the New CT Rules implement the Helsinki Declaration, is it just a matter of ensuring compliance by key players? Well, yes, but as you will hear during the panel discussion, there are deficiencies.

 

The most significant is the morality of denying access to the knowledge that was obtained in the clinical trials. This knowledge should be shared and Principle 36 of the Helsinki Declaration mandates it – especially since volunteers risk their lives believing that their participation would help mankind, and science progresses best when knowledge is shared. Sadly, the data obtained in the trial is treated as a commercial secret. Justice Bhat alluded to this issue – the regime for data exclusivity is immoral and inhuman and should find no place in civilised society.  A consequence of data exclusivity is that many mistakes will be made and many lives have been and will be lost – all of which are completely avoidable. If only the clinical trial data was shared, subsequent trials would be safer. We will not be killing people while figuring out how they died while, all that time, someone else already knew but just would not tell us.

 

You will hear from other panellists how the pandemic has tested the “system”. I am reminded of a popular saying in shipping towns – “A ship in port is safe, but that is not what ships are built for; in calm waters every ship has a good captain.”

 

Sadly, you are all familiar with fabiflu, remdesivir, plasma, itolizumab, tocilizumab, ivermectin, coronil, Ayush-64…. It does n’ot give me any pleasure to tell you that you are most certainly not immune from the consequences of the New CT Rules.

 

Those of you on Twitter will know me by my handle – @grumpeoldman. You should not have expected an uplifting keynote address. I hope that at lunchtime all you young people will be scared and angry, hungry for change.  Angry that this is happening around you and scared that it could be, or is, happening to you. I assure that we old people will not be. Ultimately, you will find, … most old people lament. Some quote Shelley.  

 

O world! O life! O time!

On whose last steps I climb,

Trembling at that where I had stood before;

When will return the glory of your prime?

No more—Oh, never more!

Out of the day and night

A joy has taken flight;

Fresh spring, and summer, and winter hoar,

Move my faint heart with grief, but with delight

No more—Oh, never more!

A Lament – P.B. Shelley

 

† by Murali Neelakantan is currently Principal lawyer at Amicus. He is a dual qualified lawyer (India and UK) and among other positions, he was formerly a partner at an international law firm in London, Cipla’s first global general counsel, and Executive Director and Global General Counsel of Glenmark Pharmaceuticals.
This is his keynote speech at XIV NLSIR-SAMVA̅D: Partners Symposium.

[1] Swasthya Adhikar Manch v. Union of India2013 SCC Online SC 900.

[2]<https://www.livemint.com/Politics/hFfKjL9PP51TKf6wEiYDcJ/SC-asks-why-government-approved-162-global-clinical-trials-i.html>.

[3]<http://164.100.47.5/newcommittee/reports/EnglishCommittees/Committee%20on%20Health%20and%20Family%20Welfare/58.pdf>.

[4]<https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/>.

Call For PapersConference/Seminars/LecturesLaw School News

ILS Law College, Pune in collaboration with Swasthya Adhikar Manch, Indore announces a two day National seminar on legal aspects of Clinical Trials with the central theme being “CLINICAL TRIALS IN INDIA: LAW, REGULATION AND CHALLENGES”.

The Sub-themes for the Seminar                                                                    

Research Papers on the following themes are invited from the Student Presenters currently pursuing their LL.M.)

  1. Effectiveness of Ethics Committee in the regulatory framework.
  2. Subjects for clinical trial and their Human Rights
  3. Comparative Analysis of Consent Process for Clinical Trials in different countries and India
  4. Role and Responsibilities of institutions as well as individuals conducting trials and other stakeholders (sponsors and investigators)
  5. Critical analysis of Regulatory system for clinical trials in India

 

This is not an exhaustive list.  Students may choose to write on any other relevant topic.

Instructions for sending the abstract and papers

 

  1. Researcher must submit a 500-word abstract on any of the sub themes /any other relevant topic providing an overview of the proposed paper by e-mail to pgdepartmentils@gmail.com  on or before  17th November,2018.
  2. The researcher must include a current CV with the submitted abstract.
  3. The organizing committee will notify each researcher of whether his or her abstract has been accepted by 26thNovember 2018.  Decisions of the organizing committee to accept papers for presentation at the conference shall be final.
  4. Researchers selected by the organizing committee to participate in the conference must submit their complete paper on or before of 17th December 2018. Papers must be submitted by e-mail to pgdepartmentils@gmail.com
  5. Format for paper
  • Word limit – 4000 to 5000 words (MS Word format on A4 size )
  • Font and Font size – Times New Roman 12
  • Margin – 1’’ on each side
  • Line spacing – 1.5
  • Citation method- SILC/Blue Book

REGISTRATION FEES

Paper presenter (Other than students pursuing LL.M. in ILS Law College) Rs. 1500/-  (Including GST)
Paper presenter with one co-author (Other than students pursuing LL.M. in ILS Law College) Rs. 1500/-(Including GST) for each author.
Participant students (Other than  students pursuing LL.M. in ILS Law College) Rs.1500/- (Including GST)
Academicians (From Institutions other than ILS Law College), Research scholars, Practicing Advocates Rs. 2000/-(Including GST)

 

  • Registration fee is non refundable.
  • Registration fee covers the cost for a folder kit, lunch and high tea on both days of the seminar.
  1. Accommodation and travel expenses will not be provided by ILS Law College.
  2. Participants must attend the seminar on both days to receive a participation certificate, which will be presented only at the conclusion of the seminar.

PAYMENT MODE – ONLINE PAYMENT 

IMPORTANT DATES
Abstract submission deadline 17/11/2018
Applicants notified of the outcome 26/11/2018
Paper submission deadline 17/12/2018
Date of conference 15/1/2019 and 16/1/2019

 

CONTACT DETAILS :

(1) Swati Kulkarni (Faculty Coordinator)– 9823227597 swati.kulkarni@ilslaw.in

(2) Shaila Daware (Faculty Coordinator) – 8983625472  E-mail = pgdepartmentils@gmail.com

(3) Sampada Kangane (Faculty Coordinator) – 8983137121