Legal framework pertaining to stem-cell research fragmented: SC

The Supreme Court on Friday said the legal framework pertaining to stem-cell research is fragmented and spread out across legislations with little harmony, which makes both compliance and enforcement an uphill task. The courts observations came in a verdict that said stem-cell therapies for Autism Spectrum Disorder ASD cannot be offered by medical practitioners as a clinical service, outside an approved and monitored clinical-trial setting.

The Supreme Court on Friday said the legal framework pertaining to stem-cell research is ''fragmented'' and spread out across legislations with little harmony, which makes both compliance and enforcement an uphill task. It said the obscurity in the legal regime also enables manipulation of patients' vulnerabilities by errant medical practitioners. ''Such obscurity, whether conscious or unintended, has arisen directly from legislative shortsightedness,'' a bench of Justices J B Pardiwala and R Mahadevan said. The court's observations came in a verdict that said stem-cell ''therapies'' for Autism Spectrum Disorder (ASD) cannot be offered by medical practitioners as a clinical service, outside an approved and monitored clinical-trial setting. The judgment came on a plea that had raised concerns over the rampant promotion, prescription and administration of stem-cell ''therapy'' for treating ASD at several clinics across the country. The bench noted that the discussion in its verdict is indicative of the shortfalls and fault lines in the regulatory mechanism for stem-cell research. It said considering the nature of such research and its potential, it is imperative to ensure that the law in this regard is accessible and clear. ''As things currently stand, the legal framework pertaining to stem-cell research is fragmented and spread out across legislations with little harmony. This makes both compliance and enforcement an uphill task,'' the bench said. The court said it finds it apposite to suggest a consolidation of rules, regulations and guidelines to govern stem cell-based clinical trials and research. It said the legislation ought to address certain points, including clearly defining stem cells and their derivates and laying down a specific procedure for application for clinical trials, including a flexible yet definite list of standards or guidelines that need to be adhered to. The bench said ideally, the National Guidelines for Stem Cell Research (NGSCR), 2017, and the National Ethical Guidelines should be given a clearer statutory recognition through these provisions. It suggested setting up a protective net for the safety and welfare of the human subjects in these trials through a rights-based approach, including patient disclosure and consent protocols. ''If the patient is opting for an unproven therapy in a clinical-trial setting, then a higher standard of voluntary, free, informed consent and associated protocols must be set,'' it said. The bench said the patients undergoing experimental therapies in a clinical-trial setting should not be charged any amount for ''treatment'', rather their participation is voluntary. ''In case of injury or death, there should be a provision for interim compensation on immediate basis,'' it said. The bench said a reasonable timeline should be there for the completion of the licensing and approval procedures and there should also be periodic inspections of the clinical-trial site. It said the procedure for approval and licensing of stem-cell banks, along with the list of standards and guidelines that need to be complied with, should be specified. The bench also suggested laying down penalties for the violation of the law, with imprisonment in cases where the health of the patient or the trial subject is endangered. ''For the aforesaid points to be addressed in a meaningful manner, it is also important that a dedicated authority that has clear and well-defined powers of regulatory oversight is created,'' it said. The bench suggested that the NAC-SCRT (National Apex Committee for Stem Cell Research and Therapy) is constituted once again to ensure proper and coherent monitoring and regulation of stem-cell research. The court said it is cognisant of the profound difficulties faced by individuals diagnosed with ASD and their caregivers, which often drive them to explore experimental or unproven interventions in the hope that even partial symptomatic relief may be achieved. It noted that a pre-condition for a valid consent to be obtained is the disclosure of adequate information concerning the nature of the medical treatment, so that a patient knows what he is consenting to. ''Consent is a mode of exercising patient autonomy. Since consent does not confer on a patient the right to demand a particular form of treatment, patient autonomy cannot be stretched to seek an entitlement to subject oneself to a clinical procedure that is scientifically unvalidated, ethically impermissible and outside the bounds of reasonable medical practice,'' the bench said. It said consent is an informed authorisation, grounded in adequate disclosure of the nature, procedure, purpose, benefits, effects, alternatives, substantial risks and adverse consequences of refusing treatment. The bench said where the requisite information is unavailable, a choice cannot mature into a valid consent. ''We have already arrived at the finding hereinabove that therapeutic use of stem cells in ASD cannot be offered as a service by medical practitioners until there is further research, which establishes this as a sound and relevant medical practice,'' it said. It added that although one cannot demand that a form of medical intervention be permitted to be administered, one would still have the liberty to participate in an approved and regulated research or clinical trial involving such medical interventions. The bench said it is as clear as a noon day that the lack of safeguards for biomedical and health research in therapeutic use of stem cells is stark.

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