The Biotech Vault: Exploring Biobanking Laws and Data Sharing Challenges in India

I. Introduction

In the age of biotechnology, where do we draw the line between privacy and progress?

Biobanking refers to the systematic collection, processing, and storage of biological samples including blood, DNA, tissues, cells, and organs together with personal and health information used to power scientific research. Biobanking has a long history starting from the early days of human anatomical collections however it was the immortalized cells of Henrietta Lacks, who never authorized their sampling, that marked the beginning of a new phase in biomedical research. Currently, biobanks play a critical role, not only in genetic and molecular biology but also in the development of new drugs.

Biobanking provides the foundation for many initiatives like the Genome India and Phenome India projects, which aim at mapping the genetic and phenotypic variability of the population. These have the potential to unlock new doors in the realm of precision medicine but the law lags while the technology soars. For instance, in India, biobanking activities are largely guided by mere soft codes in the form of guidelines rather than enforceable statutes with legal backing.

The lack of regulation impedes developments in donor rights, and it poses critical data protection questions. With the biotechnology sector set to grow to $300 billion by the year 2030, there is a need for comprehensive biobanking legislation to help us drive the country’s biotech sector to maturity.

II. Existing Legal Framework In India

There is no comprehensive and enforceable legislation for biobanking in India. Instead, biobanking is guided by regulations, for example, the ICMR's National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017 that give some standards of biobanking including informed consent, data privacy, and ethics committee reviews. The Department of Biotechnology’s Guidelines for Sustaining DBT Bio-Banks and Cohorts also establish certain standards of data storage and sharing.

Unfortunately, these are just recommendations and currently, laws do not exist to protect health data. In 2019, The Personal Data Protection Bill did take steps in this direction, however in 2022, it was withdrawn. Similarly, The DNA Technology (Use and Application) Regulation Bill, 2019, which proposed the creation of National and Regional DNA Data Banks for use in forensics but not biobanking purposes directly, was also withdrawn in 2023. Their successor, The Digital Data Protection Act, 2023 has not addressed these concerns altogether.

The Transplantation of Human Organs and Tissues Act, 1994, governs the removal, storage, and transplantation of organs and tissues, but does not deal with biobanking either. Without a dedicated regulatory framework, India’s biobanking landscape remains fragmented and underdeveloped. The question then arises as to why exactly we need formalised legislation in the first place. This brings us to the concept of Data Sharing in biotechnology.

III. Data Sharing

Data sharing in biotechnology refers to the exchange and accessibility of biological knowledge, information, and data generated through research for secondary use by the broader scientific community. The necessity and power of data sharing in solving problems was highlighted in the COVID-19 crisis. However, biobanking presents unique challenges in data sharing due to its dual role in storing biological specimens and associated data. Such data must ensure privacy by excluding personal identifiers and obtaining informed consent even for anonymized data sharing. High-quality, transparent, and unbiased standards are essential, particularly for cross-border data transfer.

The global scientific community has recognized the need for harmonized approaches to data sharing, as evidenced by various international guidelines. The Organisation for Economic Co-operation and Development (OECD) 1980 Data Protection Principles formed the foundation for subsequent data protection regulations like the Bermuda Agreement of 1996, Fort Lauderdale Agreement of 2003, Nagoya Protocol on Access and Benefit Sharing of 2010, Guidelines of the Global Alliance for Genomics and Health (GA4GH) of 2013 and the European Union’s General Data Protection Regulation of 2016.

India's approach to scientific data sharing is governed primarily by the National Data Sharing and Accessibility Policy (NDSAP) of 2012 but the need for harmonization with these international standards was emphasised in India by the Biotech-PRIDE guidelines of 2021. The difference in regulations between countries leads to uncertainty and inefficient data sharing and thus, there is a need for a uniform conception and implementation of data sharing regulations based on international practices. 

IV. International Standards

Worldwide, there are several frameworks to ensure quality, ethical compliance, and data protection in biobanking. For instance, the ISO 20387:2018 standard provides requirements for biobanking, which focus on quality control, risk assessment, and sustainability in the management of biological resources. The OECD Guidelines also look at ethical use of human biological materials, including questions of informed consent, donor rights, and data privacy. These frameworks are complemented by the ISBER Best Practices which are revised every few years on the basis of modern operational procedures and ethical considerations for biorepositories.

In Europe, General Data Protection Regulation and Tissues and Cells Directive (2004/23/EC) are in place for proper ethical use of human biological materials. Estonia and Finland have been recognized for countrywide biobank legislation that particularly include broad consent mechanism and strong security. The United Kingdom Biobank is governed through the Human Tissue Act, 2004 and an Ethics and Governance Framework (EGF).  Laws such as the Common Rule for Human Subjects’ Research and the HIPAA Privacy Rule for protection of health information are under the decentralized system of the United States. Additional data privacy for sensitive research is provided by the use of Certificates of Confidentiality.

This is an opportunity to fill the regulatory gap and develop a holistic legal framework based on international best practices but tailored to India’s particular socio-cultural and legal environment. The unique ethical challenges posed by all biotech-based laws are a key reason why this gap exists.

V. Ethical Considerations

Who owns the blueprint to your genetic data?

At the heart of the ethical dilemmas of biobanking is this question. When discussing the ethics of biobanking, one important issue that comes up is that of informed consent. This means that donors might agree to sample collection without fully understanding how their data is going to be used or stored (both now and in the future) and that could breed exploitation and mistrust. 

Biobanking practices are also inconsistent because of inadequate regulations. It enhances the risks of mishandled specimens and unauthorised data access. These biobanks hold sensitive and genetic data, and their misuse could lead to discrimination. Thus, the protection of donor anonymity is even more urgent now that scientific developments can potentially reidentify anonymous samples by means of genetic analysis or big data applications.

Data ownership poses another ethical dilemma. Should the rights to stored samples and derived data lie with donors, researchers, or institutions? When commercialization is involved, this lack of clarity turns out to be especially contentious. Benefit sharing remains an important problem addressed by biobank research, one that ensures that vulnerable populations who are participating in research are not subjected to exploitation and have equitable access to its benefits.

Ethical governance should ideally promote diversity and representation in the biobank samples, to prevent any bias in the related research results. There should be clear guidelines for the return of research findings to the participants, especially if the results seriously impact their health. This is important to gain public trust and improve the use of biobanks in scientific and medical research. To deal with these issues, certain key recommendations for an ideal biobanking law in India will be proposed.

VI. Framework And Legislative Recommendations

Inspiration from international standards and practices from other jurisdictions can help develop a hybrid framework which will be useful for setting up a strong and ethical biobanking ecosystem in India. This approach would improve the country’s research capabilities, as well as increase public trust and make India a global leader in biobanking governance.

Firstly, we need a centralized governance structure. This would include an executive board to carry out management, an ethics committee to monitor and, data access committees to govern data usage. Biobank governance has to be flexible to keep up with the advancements and scale of individual biobanks.

Secondly, the consent mechanisms for biobanking legislation will have to take into account India’s diverse population. Broad consent models that prioritise participant autonomy and future flexibility in research are needed. Workshops and consultations with the community are really important ways to build trust and understanding while creating holistic population-centric regulations. 

Finally, all biobank activities should be covered by Standard Operating Procedures (SOPs) of all kinds from sample collection to data management thereby ensuring a uniform mechanism, with regular updates for quality. International standards, such as GDPR and ISO 20387, should be met while addressing local needs. This endeavour requires measures of anonymization, encryption, and secure storage. Not only would this protect participant rights, but also it would aid international collaborations through compliance with global data sharing norms.

VII. Conclusion

The potential of biobanking in advancing medical research and precision medicine is large, but it can only be realized when the legal and ethical basics of biobanking are solidified. We need to close gaps in governance, lack of informed consent, and data sharing through enforceable and broad legislation. This would enable India to build an ecosystem that ensures participant rights, builds public trust, and aligns with international standards for excellence in biobanking and global data sharing.