Who Owns Your DNA? The Urgent Case for a Biobank Law in India

BiobanksBiobankA specialized facility that stores biological samples (blood, tissue, DNA) for long-term medical research and personalized medicine. are becoming an integral part of modern medicine and biomedical research. Biobanks store and analyze biological materials such as blood, tissue, DNA and genetic data and play a major role in the development of diagnostics, personalized medicine and new therapeutic developments. While laws or regulations exist in a number of countries including Finland, Sweden and United Kingdom providing a thorough oversight framework for biobanking, no such framework exists in India despite the rising use of biological samples and data in biomedical research and clinical practice. The absence of a dedicated legal framework has implications from ethical, legal and human rights perspectives.

In contrast to other types of personal data, genetic dataGenetic DataHighly sensitive information extracted from DNA that can predict health risks and reveal connections across entire populations. is stored indefinitely, easily predictable and relationalRelational DataInformation that reveals traits not just of the donor, but their relatives and community, making individual privacy difficult to isolate. (data extrapolated from the genome of one person may hold information about their relatives and entire populations). Besides, a lot of issues like ownership, privacy protection and control of one’s own biological materials remain unresolved due to lack of a specialized law. Rising commercial interest in genetic research can be problematic when the rights of biological material donors are not protected after research institutions or private companies gain a commercial advantage.

One of the most pressing ethical concerns in biobanking is informed consentInformed ConsentThe process of ensuring a participant understands the risks, benefits, and purpose of research before providing their biological samples.: Typically, individual consent models are based on a specific, defined research question (or project). A similar challenge arises with biobanks: samples are stored for long periods and the use of the samples for research purposes may not be clear until far in the future. Internationally, broad consentBroad ConsentA model where donors give general permission for their samples to be used in various future, often unspecified, research projects. models are emerging as a practical solution to this problem, but critics suggest that a broad consent model weakens donor autonomy and meaningful control over biological materials. This dilemma lies between providing scientists enough freedom to explore and yet giving the donor proper control over his and/or her biological materials and data.

Privacy issues have also been raised as it is possible to re-identify individuals using artificial intelligence and analytics, despite steps taken to anonymizeAnonymizationThe technical process of removing personal identifiers from biological samples to prevent the re-identification of donors. biological materials. Without special protection, genetic data may be misused, disclosed or used in an unauthorized manner in employment, insurance and other areas. General data protection and privacy statutes do not adequately provide the necessary protection to genetic data, nor do they address the unique risks posed by biobanks. Furthermore, there are currently no established standards for biobanks, which is problematic for data-sharing and cross-border transfers.

Commercialisation of biological material includes issues of property and benefit sharing. Biobank-based research often produces valuable commodities such as pharmaceuticals, patentable and patented technologies and diagnostic products, yet participants whose biological material enables this research often receive few or no direct benefits from its commercialization, raising issues of fairness and exploitation. International case law such as Moore v Regents of the University of CaliforniaMoore v. RegentsA landmark 1990 case ruling that individuals do not have property rights to their discarded cells used for medical research and patents. indicates that the ownership and control of human biological materials can be ambiguous once they have left the body.

Biobanks also implicate important human rights issues. Biobanks collect and process biological information that is fundamentally tied to individuals’ Article 21Article 21The constitutional right to Protection of Life and Personal Liberty in India, which the Supreme Court has interpreted to include the Right to Privacy. rights to privacy, dignity, and bodily autonomy under the Indian Constitution and may lead to genetic discriminationGenetic DiscriminationThe unfair treatment of individuals based on their genetic information by insurers, employers, or other social entities. where privacy is not adequately protected. The environmental effects of biobanks include their large-scale storage systems that consume energy, biomedical waste production and the energy consumption of their cooling systems. Despite such possible environmental impacts, environmental considerations have been generally absent in discussions of biobanks and biobank governance.

There are no laws governing biobanks as statutory laws in India. Although biosciences research in India is strong and India has a growing involvement in the processing of genetic data, the actual governance and regulation of biobanks in India is limited to the guidelines promulgated by the ICMRICMRThe Indian Council of Medical Research, the apex body responsible for the formulation and promotion of biomedical research guidelines in India. and generic data protection laws. However, the utility of the instruments for biobanking is limited because they do not adequately address issues such as informed consent, privacy, commercialization, benefit-sharingBenefit SharingThe principle that participants should receive some form of reward or access to treatments derived from research using their biological data., environmental sustainability and human rights. An absence of a dedicated regulatory framework can also pose challenges in assigning accountability, donor rights and ownership of biological material.

There is thus an urgent need for a thorough biobank legislation in India, which integrates the ethical guidelines with enforceable legal mandates, and standardizes informed consent, data governance, storage, transfer, commercialization and donor protection aspects, while instituting institutional mechanisms for oversight and accountability of biobanks in the country. The creation of a biobanks law would provide guidance to regulators, improve public trust in biomedical research, and promote justifiable scientific advancement. However, as the practice of gathering biological information becomes the foundation of much future health and science, the law must not sacrifice autonomy, dignity and justice in the pursuit of scientific progress.