Bioethics & Medical Ethics

What is Bioethics?

Bioethics is the study of the ethical questions arising from advances in biology and medicine. It applies ethical principles to decisions in healthcare, medical research, and biotechnology. The discipline emerged as a distinct field in the mid-twentieth century in response to the increasing power of medical technology to prolong, alter, and create life.

The foundational framework of modern bioethics rests on four principles articulated by Tom Beauchamp and James Childress in Principles of Biomedical Ethics (first published 1979):

These four principles — often called the "Georgetown mantra" — form the baseline for evaluating virtually every medical ethics dilemma.

Euthanasia

Euthanasia means deliberately ending a life to relieve suffering. It is one of the most contested bioethical issues globally.

Types of Euthanasia

India's Legal Position

Aruna Shanbaug v Union of India (2011): A two-judge bench (Markandey Katju and Gyan Sudha Mishra JJ) issued guidelines permitting passive euthanasia under strict High Court supervision, while denying euthanasia to Aruna Shanbaug herself. This was the first judicial recognition of passive euthanasia in India.

Common Cause v Union of India (2018): A five-judge Constitutional Bench (Dipak Misra CJI, A.K. Sikri, A.M. Khanvilkar, D.Y. Chandrachud, Ashok Bhushan JJ) held that the right to die with dignity is a fundamental right under Article 21. The judgment:

• Permitted passive euthanasia for terminally ill patients
• Recognised the validity of Advance Directives (Living Wills) — written instructions by a competent adult about end-of-life care
• Mandated a two-tier medical board (at least 5 years' experience) to certify the patient's condition
• Active euthanasia remains illegal in India

Global Comparison

Surrogacy

Altruistic vs Commercial Surrogacy

Surrogacy (Regulation) Act, 2021 — Key Provisions

• Intended parents: Indian married couples (married for at least 5 years); women aged 23–50, men aged 26–55; also covers widows and divorced women aged 35–45
• Surrogate eligibility: Must be a close relative of the intended parents; married woman aged 25–35 with at least one child of her own; can act as surrogate only once
• A State Surrogacy Board and National Surrogacy Board regulate all proceedings
• Child's rights: Child born through surrogacy is deemed the biological child of the intending parents with full legal rights

ART (Assisted Reproductive Technology) Regulation Act, 2021

Passed on 20 December 2021, the ART Act regulates IVF clinics and gamete banks. It prohibits importing human gametes, mandates written informed consent, and ensures insurance coverage for oocyte donors for 12 months. Penalties for violations range from ₹5–10 lakh (first offence) to 3–8 years' imprisonment for repeat offences.

Ethical Concerns

• Commodification: Commercial surrogacy treats a woman's body as a service instrument
• Exploitation: Women from economically weaker sections may be coerced into surrogacy
• Consent quality: Whether fully free and informed consent is possible under economic duress
• Child welfare: Anonymity of gamete donors raises identity questions for children

Organ Donation & Transplantation

Legal Framework in India

The Transplantation of Human Organs Act, 1994 regulated removal, storage, and transplantation of organs. The 2011 Amendment (rules notified in 2014):

• Included tissues alongside organs
• Expanded definition of "near relative" to include grandparents and grandchildren
• Introduced brain death as a legal basis for organ retrieval
• Strengthened penalties against organ trafficking

NOTTO (National Organ and Tissue Transplant Organisation): Apex body under DGHS, Ministry of Health, located at Safdarjung Hospital campus, New Delhi. It coordinates a three-tier network: NOTTO (national), ROTTO (regional), SOTTO (state).

Ethical Issues

Informed Consent & Patient Rights

The doctrine of informed consent requires that a patient, before agreeing to any medical procedure, be given adequate information about the nature, benefits, risks, and alternatives of the procedure — and that consent be voluntary and competent.

Samira Kohli v Dr Prabha Manchanda (16 January 2008): The Supreme Court held that a doctor who performed hysterectomy and removal of ovaries without the patient's prior specific consent was liable for medical negligence. The Court established that consent must be real — not merely formal — and that an unconscious patient's mother cannot substitute for the patient's own consent in non-emergency situations.

Therapeutic privilege: The contested doctrine allowing a doctor to withhold information if disclosure would cause psychological harm — ethically problematic as it overrides autonomy.

Right to refuse treatment: A competent adult has the right to refuse any medical procedure, even life-saving ones — grounded in autonomy under Article 21.

Allocation of Scarce Medical Resources

When resources are scarce (ICU beds, ventilators, organs, vaccines), allocation decisions involve competing ethical frameworks:

The COVID-19 pandemic brought these debates into acute focus, particularly around ventilator rationing protocols in overwhelmed hospitals.

Clinical Trial & Research Ethics

Key International Frameworks

ICMR's 2017 Guidelines expanded scope to include socio-behavioural research and mandated compensation for research-related harm in investigator-initiated studies.

Ethics of Genetic Testing & CRISPR

Pre-implantation genetic diagnosis (PGD): Testing embryos before implantation to screen for genetic disorders raises concerns about selective reproduction and the beginning of "designer babies."

He Jiankui controversy (2018): Chinese scientist He Jiankui announced on 26 November 2018 that he had created the first gene-edited human babies (twin girls) by using CRISPR-Cas9 to disable the CCR5 gene to prevent HIV infection. The international scientific community condemned the experiment as premature and unethical — germline editing is heritable by future generations, and risks were not adequately understood. He was sentenced to three years in prison by a Chinese court.

Germline vs somatic editing:

Designer babies debate: PGD for non-medical traits (intelligence, appearance) crosses from therapy into enhancement — raising justice concerns (only available to wealthy), slippery slope to eugenics, and questions about consent of the future child.

Exam Strategy

Bioethics is a recurring theme in GS4 case studies. Approach questions by:

1. Identifying the ethical conflict — typically between two or more of the four principles (e.g., autonomy vs beneficence in refusing treatment)
2. Citing Indian legal landmarks — Aruna Shanbaug (2011), Common Cause (2018), Samira Kohli (2008) add authority to your answer
3. Linking to constitutional rights — Article 21 (right to life with dignity), right to health as an implied right
4. Offering a balanced view — acknowledge tensions without giving a simplistic answer
5. Using tables or structured lists in 250-word answers to cover multiple dimensions efficiently

For case studies involving a doctor facing resource allocation or a patient refusing treatment, always begin with the ethical framework (four principles), apply relevant law, and conclude with a recommendation that balances all stakeholders.