India - Pharmaceutical Industry - Clinical Trials

Indian Supreme Court asks pharmaceutical companies for specific details on clinical trials

India - Pharmaceutical Industry - Clinical Trials

Indian Supreme Court asks pharmaceutical companies for specific details on clinical trials

Concerning a petition on human rights violations in clinical trials the Indian Supreme Court has issued notice to the pharmaceutical companies GlaxoSmithKline (UK) und Merck (USA) and asked for specific details on the trials. In the same hearing on 12 August, the Court accepted an amicus curiae brief the ECCHR submitted in the case on 11 February 2014. According to ECCHR, "a proper investigation should include the organizations conducting the trial as well as the pharmaceutical companies that benefit from the scientific results."

Case

In 2009, the States of Andhra Pradesh and Gujarat launched a research project for the vaccination against the human papilloma virus (HPV) which can cause cervical cancer. Adolescent girls between the ages of 10-14 in the States of Andhra Pradesh and Gujarat were to be vaccinated. The vaccines were provided by GlaxoSmithKline and Merck. The project was designed and executed by PATH (Program for Appropriate Technology in Health) and funding was received from the Bill & Melinda Gates Foundation. In April 2010, however, the Government of India suspended the program as several violations of ethical standards by PATH were widely reported by human rights organizations. However, by that time, 24,000 girls were already vaccinated. A governmental inquiry commission had especially questioned the fact that school head masters signed consent forms on behalf of the children. Women's health activists now seek accountability and brought a public interest petition to the Court.

Context

This case gives the Indian Supreme Court the opportunity to address the obligations of trial sponsors and manufacturers. Therefore, ECCHR's brief offers a review of relevant standards for trial sponsors and manufactures that have been developed in international treaties, legislation, and jurisprudence. This comparative analysis can inform the standard of care that can be expected from "reasonable corporations." The Affidavit is supported by legal experts from the Business and Human Rights Project at Essex University. In this case, special care was required by three separate human rights conventions. The trial subjects were young girls between 10-14 years old, and several of them were from tribal backgrounds. They were thus particularly vulnerable and entitled to special protection under the Convention on the Rights of the Child, the Convention on the Elimination of All Forms of Racial Discrimination and the Convention to Eliminate All Forms of Discrimination Against Women.

Principles

Q&A: The HPV proceedings before the Indian Supreme Court

Public interest litigation (PIL) was developed by the Indian Supreme Court in the late 1970s. It allows members of the public to file a petition on behalf of others who are not able to approach the court. It aims to "bring justice within the reach of the poor masses, who constitute the low visibility area of the Humanity" as the Court put it in one of its cases (Indian Supreme Court P.U.D.R vs UOI, in AIR 1982 SC 1473).

In its guidelines the court indicates that it will accept the following issues as a PIL petition: bonded labor, neglected children, petitions from prisoners, petitions against the police, atrocities on women, children, scheduled casts and tribes, environmental matters, and "other matters of public importance." The litigation does not need to be adversarial in nature, in terms of one party seeking relief against another. It is rather intended to vindicate the public interest by demanding that violations of constitutional and legal rights of a large number of people will be noticed and redressed. A PIL can be filed by any "public spirited" citizen.

Petitioner 1: Kalpana Mehta, founding member of Saheli Women's Resource Centre. For 30 years, she has been active in the women's health movement. She worked on campaigns against hazardous contraceptives and for a women-centric approach to contraception. For the past years she has been with the organization Manasi Swasthya Sansthan in Indore to provid equality health care to economically disadvantaged women.

Petitioner 2: Nalini Bhanot, Voluntary Health Association of India in the area of public health. She has authored Taking Sides, a book on primary health care issues and has worked on child rights and various other initiatives relating to PDS, an acute Iodine deficiency.

Petitioner 3: V Rukmini Rao from the Gramya Resource Centre for Women. The Centre's vision is to create a just society, which will provide more political, social and economic opportunities for women. They especially focus on tribal and dalit women, to help them achieve their rights, improve their lives and realize their potential. They work closely with community-based organizations, women's organizations, youth leadership, and like-minded civil society organizations to seek justice for marginalized communities.

1. The right to informed consent
Valid informed consent requires the following elements: voluntarism, information disclosure and decision-making capacity. According to Article 7 of the International Covenant on Civil and Political Rights (ICCPR) medical experimentation without informed consent is considered "torture or cruel, inhuman or degrading treatment or punishment". Moreover "[i]n particular, no one shall be subjected without his free consent to medical or scientific experimentation."

2. The right to health
Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) recognizes the right of everyone to enjoy the highest attainable standard of physical and mental health. A lack of monitoring during a clinical trial constitutes also a violation of this right to health, since monitoring is essential to identify injuries and respond promptly and adequately. Article 12.2(d) ICESCR requires States to take step towards the "creation of conditions which would assure to all medical services and medical attention in the event of sickness." The creation of these conditions is hindered if a proper monitoring system is not set up.

3. The right to special care
In this case the trial subjects were entitled to special care. This right is entailed in three different international human rights covenants:
  • The Convention on the Right of the Child (CRC). Article 24 (1) affirms the rights of the child to the enjoyment of the highest attainable standard of health.
  • The Convention on the Elimination of All Form of Racial Discrimination (CERD). Article 5e (iv) obliges the States to guarantee the right of everyone in the enjoyment of the right to public health and medical care.
  • The Convention to Eliminate All forms of Discrimination Against Women (CEDAW). Article 12(1) obliges the States to take "all appropriate measures to eliminate discrimination against women in the field of health care in order to ensure (..) access to health care services."

According to the petitioners, the HPV vaccination project may have violated the Constitution of India. In particular, Article 21's protection to life and personal liberty, as well as Articles 14 and 15 which provide for the right to equality and non-discrimination. The petitioners also allege violations of the International Convention on Economic, Social, and Cultural Rights (ICESCR) and the Convention for the Elimination of all forms of Discrimination Against Women (CEDAW), namely the right to the highest attainable standard of physical and mental health and to ensure that girls give informed consent and have access to adequate health care.

The inadequate informed consent process is further suggested to violate Indian regulations, because Schedule Y of the Drugs and Cosmetics Rules states:

"…All pediatric participants should be informed to the fullest extent possible about the study in a language and in terms they are able to understand. Where appropriate, pediatric participants should additionally assent to enroll in the study. Mature minors and adolescents should personally sign and date a separately designed written consent form..." (Paragraph 161 of the petition).

The petitioners also argue that the ICMR guidelines for biomedical research were not adhered to, even though they deal in detail with the informed consent process (Paragraph 193 of the petition):

"For all biomedical research involving human participants, the investigator must obtain the informed consent of the prospective participant or in the case of an individual who is not capable of giving informed consent, the consent of a legal guardian. Informed consent protects the individual's freedom of choice and respect for individual's autonomy and is given voluntarily to participate in research or not. Adequate information about the research is given in a simple and easily understandable unambiguous language in a document known as the Informed Consent Form with Participant/Patient Information Sheet."

There are nine respondents mentioned in the petition: the Union of India, the Drugs Controller General of India (DCGI), the Indian Council of Medical Research (ICMR), the States of Andhra Pradesh and Gujarat, PATH International, the manufacturers MSD Pharmaceuticals Pvt. Ltd. and GlaxoSmithKline Pharmaceuticals Asia Pvt. Ltd., and Christian Medical College. The Court has so far only asked the Union of India, the DCGI, and PATH for replies.

A particular feature of public interest litigation is that the court can, for example, order government agencies to conduct certain investigations, provide guidelines for future action, or provide certain information. Thus, the petitioners demand:
  • Access to information about the clinical trial and HPV vaccines in India, specifically information from PATH, the states of Andhra Pradesh & Gujarat, and the DCGI
  • Order the Christian Medical College to do a fact-finding mission regarding the current health of those administered the vaccines
  • Order to determine culpability of the CRO and the state governments
  • Order to start criminal investigation
  • Provide guidelines regarding civil and criminal liability for clinical trials in India

It is not easy to trace the girls that were vaccinated. There were fact-finding missions to the state of Gujarat and the state of Andhra Pradesh. These led to interviews with some of the vaccinated girls or their families.

Public interest litigation petitions are immediately filed to the Supreme Court if the facts concern more than one state.

The doctrine of informed consent, which receives widespread recognition and use in the context of medical treatment, is of equal if not greater significance within the context of drug experimentation. Medical practitioners abide by a code of moral conduct that requires them to operate in the best interests of the patient similar to a fiduciary, researchers follow a different set of professional norms. They undertake research projects for the furtherance of scientific knowledge. Clinical trials can only be examined for their adherence to a scientifically and ethically sound protocol, which outlines the risk-benefit justification for participating in the study.

Related Topics

documents

glossary

An amicus curiae brief is a submission to a court setting out a legal position.
Public Interest Litigation refers to cases that concern issues of broad public concern.
The UN Convention on the Rights of the Child sets out fundamental standards for the protection of children.

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