This is the 25th post of our COVID19 series.
Prominent research institutes like the University of Oxford, Bill & Melinda Gates Medical Research Institute, and various others have made significant advancements in developing a COVID-19 vaccine, and have already started clinical trials. Though clinical trials are an indispensable part of vaccine development, it raises various human rights and ethical concerns. In such a scenario, it is important to explore the underlying issues and set some minimum standards of due care in clinical trials. There are various international instruments discussing the importance of consent while conducting clinical trials. In this article, I am going to highlight such principles. Moreover, I would focus on the stance of the Indian judiciary with respect to guidelines for clinical trials and the protection of right to life. This issue becomes even more important in light of the fact that India’s first vaccine candidate, Covaxin, has been approved for clinical trials.
INTERNATIONAL PERSPECTIVE ON MEDICAL EXPERIMENTATION
The most important aspect of clinical trials is consent. The Nuremberg code, which symbolizes the first concrete step towards the ethical treatment of participants, provides that the “voluntary consent of the human subject is essential”. Similarly, the Helsinki Declaration considers that the rights and interests of the human subjects take precedence over medical research. International Covenant on Civil and Political Rights states that any medical experimentation done in the absence of informed consent is considered cruel and no one shall be subjected without his free consent to medical or scientific experimentation.
Institutions across the globe increased the threshold of consent and mandated it to be “informed consent”. World Health Organization in its ‘Good Clinical Research Practice Guidelines’ has discussed the concept and importance of informed consent.
Article 21 and the Duty of State
Article 21 of the Indian Constitution casts an obligation on the state to preserve human life. Participants of clinical trials often suffer serious adverse events due to lack of proper regulations, absence of uniform standards, arbitrary guidelines, and ineffective implementation of legislative provisions. The state in its capacity of parens patriae needs to take special care of those who are unable to do it themselves and failure to give effect to the right to life leads to violation of the right to health, right to livelihood, and right to equality.
The 59th Report on the functioning of the Central Drugs Standard Control Organization had observed that the regulatory framework concerning medical experimentation in India is not stringent enough and is violated at will. Despite such cognizance of an inadequate regulatory framework, the Indian Government has mostly been negligent. Death of 4,534 participants due to serious adverse events during clinical trials where only 160 cases have received compensations from the pharmaceutical companies is a testament to the same.
Moreover, we cannot restrict the ill-effects of clinical trials to death. The right to life does not merely mean the absence of death, it includes the right to protection against torture or cruel, inhuman, or degrading treatment. Any medical procedure done without proper consent, safety procedures, guidelines, and monitoring deny a participant the much-valued human dignity which they are entitled to live with.
In furtherance of this, the Supreme Court of India has adopted the threshold of ‘real consent’ similar to the UK. In the case of Samira Kohli vs Dr. Prabha Manchanda & Anr., it has been observed that before any medical treatment “the consent obtained should be real and valid, which implies: the patient should have the capacity to consent; consent should be voluntary; consent should be based on adequate information concerning the nature of the treatment procedure so that he knows what he is consenting to.”
Informed Consent and Economic Coercion
As per Indian Council for Medical Research, informed consent is a continuous process involving three main components: (i) providing relevant information to potential participants; (ii) ensuring competence and comprehension of the information and; (iii) voluntariness of participation.
Considering India is home to the world’s largest illiterate population, the illiterate trial participants are prone to a higher degree of exploitation. They are not aware of what they are being subjected to and their rights during and post trials. They are also not aware of the recourse in case of injury and hence, their consent is not ‘free’ and ‘informed’. The abject poverty in India gives rise to the concept of economically coerced consent. Economic coercion includes a force arising from the compulsion of economic circumstance which leaves no choice of alternatives to a person compels him to provide labor or service. The huge amount of money paid to a trial participant may attract the socioeconomically disadvantaged who might consent to the trial because of the lure of money. This may even compel them to provide false information about themselves in order to qualify for the trials. With the serious economic downfall due to the pandemic, it becomes even important that people do not fall prey to the economic coercion.
Treatment of Incapacitated Individuals: India and UK
As informed consent permeates the whole process of clinical trials, it is pertinent to highlight the treatment of incapacitated persons in India. In India, all the incapacitated individuals are treated as a homogeneous group as opposed to the UK. In the UK, incapacitated persons are divided into three categories. First, people who gave consent prior to incapacitation, second, people who neither gave their consent nor negated it and third, who revoked their consent prior to incapacitation. The individuals in the first category can revoke their consent; the legal representatives can consent on behalf of the individuals in the second category and individuals in the third category cannot be subjected to clinical trials. There is no such distinction in India. This in turn can be used by the economically marginalized as a source of income and free medical care, who by acting as the legal representatives may consent on behalf of their incapacitated family relatives. [see Regulation 2(c), Third schedule of New Drugs and Clinical Trials Rules, 2019.]
Clinical Trials and Indian Judiciary
Clinical trials have been subject to discussion in India since the last decade. An NGO, Swasthya Adhikar Manch, filed a Public Interest Litigation (PIL) in the Supreme Court of India [Swasthya Adhikar Manch v. Union of India] against various irregularities during the clinical trials such as violation of the law governing clinical trials i.e. Drug & Cosmetics Act and ethical guidelines provided by Indian Council for Medical Research and international guidelines mentioned earlier, thereby alleging violation of Article 21 of the Indian Constitution. Another PIL, Kalpana Mehta v. Union of India was filed after the death of seven tribal girls during clinical trials of Human Papilloma Virus vaccination in Andhra Pradesh and Gujarat.
In both cases, the court applauded the efforts of various NGOs for bringing such gross violation of fundamental and human rights to the attention of the court. Despite this, due to the lackadaisical approach of the government and the DCGI, the Court has not reached a final decision in both the cases yet. However, as a result of SCs’ multiple orders, the government introduced the ‘New Drugs and Clinical Trials Rules, 2019’ in order to promote a more transparent clinical research process. These new rules inter alia provide for time-bound approval of clinical trials, monitoring of trials and decision regarding compensation by the Ethics Committee, in case of adverse events.
The Government’s inability to curb illegal trials has been time and again criticized by the Indian courts. In Rahul Dutta v. Union of India and Swasthya Adhikar Manch, Courts have stated that the untimely death of trial participants is a gross violation of the fundamental right to life guaranteed under Article 21 of the Indian Constitution. The Apex Court went on to observe that “unrestrained clinical trials are causing disaster to human life”. This is a clear reflection of the poor enforcement of ethical principles during medical experimentation in India.
The stance of the Indian judiciary in all the aforementioned cases clearly shows that clinical trials conducted without the ‘informed consent’ of participants is a violation of their fundamental right to live with dignity. In light of the fact that ‘right to live’ has been considered an essential human right under Article 3 of the Universal Declaration of Human Rights, it is clear that an illegal clinical trial is in violation of international principles as well.
India being a developing country and home to a diverse population has always been a favorable location for clinical trials. The inadequate regulation of clinical trials and economic insufficiency further makes it easier for corporations to get away with violation of the rights of trial participants.
According to the UNHCR, states have an obligation to respect, protect, and fulfill a citizen’s right to health. Keeping in mind that vaccine development requires clinical trials aiding human health and well-being in the long term, it is essential that it is not achieved at the expense of human rights during the process. In such a scenario, states need to exercise a higher level of diligence to protect the rights of its citizens by ensuring a minimum standard of care in clinical trials. Considering that the aforementioned cases are still pending before the apex court, there is some semblance of hope that the rights of trial participants will be protected in the future. The judiciary and the legislature need to take more proactive actions in order to curb the menace of illegal clinical trials and ensure the highest degree of transparency and regard for human rights.
The author is a student at the National Law University, Jodhpur.