The Supreme Court of India has held that a patient cannot insist on receiving an unproven or experimental medical treatment as a matter of right, even if they voluntarily consent to it. The observation came in a case concerning the widespread use and promotion of stem cell therapy for Autism Spectrum Disorder (ASD), a treatment that has not been validated by reliable scientific evidence and is not recognised as standard clinical practice.
Key Points of the Judgment
The Court emphasised that patient autonomy does not extend to demanding unproven therapies that lack adequate information about their safety, efficacy, and outcomes.
It reaffirmed established legal principles that valid medical consent must be based on “adequate information”, which includes a clear understanding of treatment benefits, risks, alternatives, and consequences of refusal — a requirement not met for unproven therapies like stem cell treatment for ASD.
The Bench noted that where credible scientific evidence is absent, proceeding with such treatments could amount to medical malpractice and a breach of ethical standards.
Medical Dialogues
The Court clarified that patients may participate in approved clinical trials designed to study such treatments under regulated conditions, but they cannot compel medical practitioners or institutions to provide such treatments in routine practice.
Legal Importance
This ruling strengthens safeguards in medical law by ensuring that experimental or unverified treatments cannot be imposed upon healthcare providers simply because a patient requests them. It reinforces that scientific evidence and regulatory approval are essential before a treatment can be offered as a matter of clinical right.
