Precision medicine is ushering in a new era of personalized healthcare, with its foundations taking shape during the completion of the Human Genome Project by scientists.

Current legal framework governing biobanks in India

• Lack of Comprehensive Legislation: India lacks specific, comprehensive laws governing biobanks. The current framework consists of guidelines rather than enforceable laws, creating gaps in the regulation of biobanking practices.
• National Ethical Guidelines by ICMR: The Indian Council for Medical Research (ICMR) has issued guidelines on ethical practices in biomedical research involving human participants. However, these guidelines are not legally binding and do not address all aspects of biobanking, such as long-term storage and data sharing.
• Department of Biotechnology (DBT) Standards: The DBT has certain practices in place for data storage and analysis, but these also lack enforceability and do not fully cover issues such as informed consent and privacy.
• Absence of a Single Regulatory Authority: India currently does not have a dedicated regulatory authority to oversee biobanks, which leads to inconsistencies and limited oversight in biobanking activities.

Privacy concerns impact biobank operations and precision medicine

• Informed Consent Issues: Participants often give consent without detailed information about how their biological samples and associated data will be used, who will have access, and for how long. This lack of transparency raises privacy concerns.
• Genetic Data Privacy Risks: Genetic information can reveal intimate details about an individual’s health and predisposition to diseases, potentially affecting their family members. If data privacy is not robustly protected, it may lead to genetic discrimination in insurance or employment.
• Data Sharing Without Proper Regulation: In the absence of clear legal provisions, data or samples could be shared without proper consent, risking misuse by pharmaceutical companies or research organizations, including foreign entities.
• Impact on Public Trust: Weak data and privacy protections may reduce public willingness to participate in biobank projects, thus limiting the scale and diversity necessary for effective precision medicine research.

Ethical implications of biobanking practices in India

• Ownership and Benefit Sharing: Without legal protections, there is ambiguity regarding the ownership of biological samples. Individuals contributing samples may not receive benefits from commercial applications resulting from their data, raising ethical concerns about fair compensation.
• Consent Transparency: Participants may not fully understand the scope of their consent, especially regarding future uses of their samples and data. This lack of clarity can be considered ethically problematic, as it may involve the exploitation of participants’ contributions.
• Risk of Misuse or Mismanagement: Inconsistent regulations and the absence of penalties for ethical violations create a risk of mishandling samples, unauthorized data access, and exploitation, which may compromise research integrity.
• Discrimination Risks: Genetic information obtained from biobanks could be used to discriminate against individuals based on their health risks or genetic traits, which raises concerns about ethical and legal safeguards.

Road ahead

• Establish Comprehensive Legislation: Develop and implement a comprehensive legal framework specifically governing biobanks, including clear guidelines on informed consent, data protection, ownership rights, and benefit sharing.
• Create a Regulatory Authority: Establish a dedicated regulatory authority to oversee biobank operations, ensuring compliance with ethical standards and legal requirements.