Introduction

Risk comparison with existing therapies is an essential part of medical decision-making, clinical research, and biotechnology regulation. It requires evaluating the risks and benefits of a proposed treatment against those of currently available standard treatments, alternative therapies, and—where relevant—no treatment. The purpose is to determine whether a new intervention offers a meaningful advantage or exposes patients to risks that are not justified by its expected benefits.

This comparison is particularly important when a new drug, gene therapy, stem-cell intervention, or other experimental treatment is introduced. A therapy may appear promising, but its safety and effectiveness cannot be assumed merely because it is innovative. Patients must receive accurate information about the evidence supporting the new treatment, the uncertainties involved, the risks of established therapies, and the consequences of refusing or delaying treatment.

In India, risk comparison is not recognised as a separate fundamental right. However, it is closely connected with informed consent, patient autonomy, medical ethics, and the constitutional protection of life and personal liberty under Article 21.

Important Case Laws

1. Yash Charitable Trust v. Union of India, 2026 INSC 96

In this significant judgment dated 30 January 2026, the Supreme Court examined the commercial administration of stem-cell interventions for Autism Spectrum Disorder (ASD). The Court distinguished established medical care from experimental treatment and observed that conventional therapies are supported by accumulated scientific evidence, whereas novel interventions may lack adequate evidence of safety and effectiveness.

The Court held that stem-cell treatment for ASD cannot be offered as a routine clinical service outside an approved and monitored research or clinical-trial setting. It also explained that patients and parents cannot demand an unvalidated procedure merely because they have consented to it. The judgment directly illustrates why risk comparison must consider the evidence supporting existing treatment and the uncertainty surrounding experimental alternatives.

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2. Samira Kohli v. Dr. Prabha Manchanda, (2008) 2 SCC 1

The Supreme Court held that valid informed consent requires adequate information about the nature and purpose of treatment, its benefits and substantial risks, available alternatives, and the consequences of refusing treatment.

This principle requires doctors to explain reasonable treatment alternatives rather than presenting one procedure as the only option. The decision provides the foundation for comparing a proposed therapy with existing medical treatments before obtaining consent.

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3. Jacob Puliyel v. Union of India, (2022) 3 SCC 1

The Court considered vaccine-related concerns, including individual autonomy, safety, and public-health interests. It recognised bodily autonomy while examining whether restrictions were proportionate to public-health objectives.

Although the case did not establish a general rule for comparing all therapies, it supports the broader principle that medical interventions and associated risks must be evaluated rationally, with attention to individual rights and public interest.

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Principles for Risk Comparison

A proper comparison should consider:

Safety: frequency and seriousness of adverse effects.

Effectiveness: strength and quality of evidence showing benefit.

Alternatives: available standard therapies and their outcomes.

Uncertainty: whether evidence is incomplete or still experimental.

Patient circumstances: age, condition, severity, and individual risk factors.

No-treatment option: likely consequences of refusing or delaying intervention.

Conclusion

Risk comparison with existing therapies is a central requirement of ethical medical practice and informed consent. It prevents patients from being misled by claims that a new or experimental treatment is automatically safer or more effective than established care. Indian law, particularly through Samira Kohli and the 2026 Yash Charitable Trust judgment, supports adequate disclosure, evidence-based treatment, and protection against unvalidated medical interventions being marketed as routine care. The ultimate objective is to ensure that treatment decisions are informed, scientifically justified, and consistent with patient autonomy and safety.