PATIENTS HAVE NO ABSOLUTE RIGHT TO DEMAND UNPROVEN TREATMENTS: SUPREME COURT:

The Supreme Court has recently clarified that patients cannot claim unproven medical treatments as a matter of legal right, while dealing with the issue of stem cell therapy being sought as a treatment for Autism Spectrum Disorder (ASD). The observations were made by a bench comprising Justice J.B. Pardiwala and Justice R. Mahadevan, which strongly disapproved of the use of stem cell treatment as a routine clinical intervention for ASD.

The Court noted that stem cell therapy for ASD lacks sufficient scientific validation and cannot be considered an accepted or standard form of medical treatment. It held that medical practitioners or clinics offering such unscientific therapies outside the framework of approved research and regulation are engaging in malpractice. The bench emphasised that treatments not supported by credible medical evidence cannot be legitimised merely because patients or their families are willing to undergo them.

A key issue examined by the Court was whether patient autonomy allows individuals to demand such treatments by expressing consent and choosing to proceed despite the absence of scientific backing. In addressing this, the Court held that patient autonomy does not extend to claiming an unproven treatment as a matter of right. The absence of adequate and reliable information regarding the safety, efficacy, and outcomes of stem cell therapy for ASD renders such a demand legally unsustainable.

In reaching this conclusion, the Court relied on its earlier judgment in Samira Kohli v. Dr. Prabha Manchandra and Another (2008), which laid down the principle that informed consent must be based on adequate information. The judgment underscored that meaningful consent requires the patient to be fully informed about the nature and procedure of the treatment, its intended purpose, potential benefits and effects, available alternatives, substantial risks involved, and the consequences of refusing treatment. Only when these elements are disclosed can a patient make a balanced and informed decision regarding medical intervention.

Applying these principles, the Court observed that stem cell therapy for ASD does not meet the essential requirement of adequate information. The scientific uncertainty surrounding the treatment means that patients and caregivers may develop unrealistic expectations, assuming outcomes similar to those associated with established and evidence-based therapies. Such therapeutic misconception undermines the very foundation of informed consent.

The bench held that proceeding with medical treatment when patients are operating under such misconceptions amounts to a serious breach of medical ethics. It emphasised that the validity of consent is intrinsically linked to the quality and completeness of information available about the treatment. In the absence of credible data and established protocols, consent obtained for stem cell therapy in ASD cases cannot be regarded as legally or ethically valid.

The Court further clarified that even if a patient voluntarily opts for such a procedure, the choice does not translate into valid consent due to the lack of adequate information that forms the basis of informed decision-making. However, it acknowledged that patients are not entirely barred from exploring experimental treatments. The Court noted that individuals retain the liberty to participate in approved and properly regulated clinical trials, where ethical safeguards, regulatory oversight, and scientific evaluation are in place.

Through this ruling, the Supreme Court reinforced the primacy of evidence-based medicine, patient safety, and ethical medical practice, while drawing a clear boundary between patient autonomy and the legal permissibility of unproven treatments.