BharatNotes 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):
| Principle | Core Meaning | Example Application |
|---|---|---|
| Autonomy | Respect for the patient's right to make informed, voluntary decisions | Obtaining informed consent before surgery |
| Beneficence | Acting in the best interest of the patient | Recommending the most effective available treatment |
| Non-maleficence | Avoiding harm; "first, do no harm" | Not prescribing a drug whose risks outweigh benefits |
| Justice | Fair distribution of benefits and burdens across society | Equitable allocation of organs or vaccines |
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
| Dimension | Types | Explanation |
|---|---|---|
| By patient consent | Voluntary | Patient explicitly requests death |
| Non-voluntary | Patient is incapable of consent (coma, infant) | |
| Involuntary | Against patient's expressed wishes — universally condemned | |
| By method | Active | Administering a lethal substance |
| Passive | Withdrawing or withholding life-sustaining treatment |
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
| Country | Legal Position |
|---|---|
| Netherlands | Active euthanasia legal since 2002; physician must confirm unbearable suffering |
| Belgium | Active euthanasia legal since 2002; extended to minors in 2014 |
| Oregon, USA | Death with Dignity Act 1997 allows physician-assisted suicide (patient self-administers) |
| India | Only passive euthanasia with advance directive; active euthanasia illegal |
| UK | Assisted dying illegal; only withdrawal of treatment permitted under court order |
Surrogacy
Altruistic vs Commercial Surrogacy
| Feature | Altruistic | Commercial |
|---|---|---|
| Compensation | Reimbursement of medical expenses only | Surrogate receives payment beyond expenses |
| Motivation | Goodwill, typically a close relative | Financial |
| Ethical concerns | Lower exploitation risk | Commodification of women's bodies |
| India's legal position | Permitted | Banned under Surrogacy (Regulation) Act, 2021 |
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
| Issue | Ethical Dimension |
|---|---|
| Organ trafficking | Violates dignity; exploits the poor as spare-part suppliers |
| Opt-in vs opt-out systems | Opt-out (presumed consent) raises autonomy questions; opt-in may cause organ shortage |
| Directed donation | Preference for same religion/caste raises justice concerns |
| Living donor pressure | Risk of subtle coercion within families |
| Brain death definition | Cultural/religious resistance; need for public education |
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:
| Framework | Principle | Critique |
|---|---|---|
| Utilitarian | Maximise total benefit; prioritise those most likely to survive | May discriminate against the elderly or disabled |
| Egalitarian | Equal chance for all (lottery system) | May waste scarce resources on hopeless cases |
| Prioritarian | Priority to worst-off or most vulnerable | Difficult to define "worst off" consistently |
| Life-cycle approach | Prioritise younger patients (more life-years to gain) | Ageist implications |
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
| Document | Year | Key Contribution |
|---|---|---|
| Nuremberg Code | 1947 | First international standard; voluntary consent is absolutely essential |
| Declaration of Helsinki | 1964 (last revised 2024) | WMA guidelines for research on human participants; distinguishes therapeutic from non-therapeutic research |
| Belmont Report | 1979 | US framework: respect for persons, beneficence, justice |
| ICMR National Ethical Guidelines | 2017 | India-specific guidelines covering 12 thematic areas; introduced broad consent and multi-centric review |
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:
| Type | Cells affected | Heritable? | Ethical Status |
|---|---|---|---|
| Somatic gene editing | Non-reproductive cells | No | Ethically closer to drug therapy |
| Germline editing | Sperm, egg, embryo | Yes | Highly contested; moratorium recommended by most scientific bodies |
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.
Recent Developments (2024–2026)
Uniform Code of Pharmaceutical Marketing Practices (UCPMP) 2024
The Department of Pharmaceuticals issued UCPMP 2024 on 12 March 2024, replacing the 2014 version. UCPMP 2024 explicitly prohibits pharmaceutical companies from offering gifts, hospitality, or monetary benefits to medical practitioners, mandates disclosure of all company-doctor interactions, and introduces a Code of Ethics for marketing representatives. This directly enforces the non-maleficence and non-corruption principles central to medical ethics.
UPSC angle: UCPMP 2024 is the current framework for pharmaceutical marketing ethics — essential for GS4 bioethics and medical professional ethics questions.
Genome India Project — Bioethics in Large-Scale Genomics (2025)
The Genome India Project was completed in January 2025, sequencing the whole genomes of 10,074 individuals from 83 diverse Indian populations. The Indian Biological Data Centre (IBDC) and Framework for Exchange of Data Protocols (FeED) were launched for regulated data access. The project raised significant bioethics questions: informed consent at scale, data privacy for indigenous communities, genetic discrimination risk, and equitable benefit-sharing of genomic discoveries — illustrating all four pillars of bioethics (autonomy, beneficence, non-maleficence, justice) in a real Indian context.
UPSC angle: Genome India is both a General Science and GS4 bioethics landmark — tests understanding of genetic data ethics, consent, and justice in research.
Exam Strategy
Bioethics is a recurring theme in GS4 case studies. Approach questions by:
- Identifying the ethical conflict — typically between two or more of the four principles (e.g., autonomy vs beneficence in refusing treatment)
- Citing Indian legal landmarks — Aruna Shanbaug (2011), Common Cause (2018), Samira Kohli (2008) add authority to your answer
- Linking to constitutional rights — Article 21 (right to life with dignity), right to health as an implied right
- Offering a balanced view — acknowledge tensions without giving a simplistic answer
- 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.
