India’s potential influence on the need for global governance of biobanks (GS Paper 2, Governance)
Context:
- The biotechnology economy or bioeconomy has seen exponential growth in market value with a greater understanding of genes and genetic modification, its impact on healthcare, and innovation in food security, bioproduction, etc.
Potential in India:
- In July 2022, India released its Bioeconomy Report, which overviews the growth in the biotechnology sector and its different fields of operation, projecting a potential market value of US$300 billion by 2030.
- The report, highlighted the relevance of biotechnology for the Indian economy in the coming 25 years, quoting an increase in biotech start-ups from “50 to over 5,300 in the last ten years” and adding the potential for this number to “further increase two times, to 10,000 plus by 2025”. This growth indicates increased research, development, and industrial participation in bioeconomy.
Biobanks:
- The data for research and development (R&D) in the field of bioeconomy can be stored in three types of data centres: Biological Resource Centres (BRCs), Biorepositories, or Biobanks.
- While all three hold biological data, biobanks are usually preserved to maintain only human-based biological data (including blood, tumour growth, and DNA samples), reserving animal and environmental data for biorepositories and BRCs.
- Biobanks collect data for addressing R&D of critical human diseases. Thus, biobanks can be of two types:
- Population-centric, that collects information from general population samples, and
- disease-centric, that gathers information based on a specific disease or genetic condition being researched.
- Another way of categorising biobanks is through the intention of research, including population biobanks, basic research biobanks, translational study biobanks, pathological study biobanks, and clinical trial biobanks.
Irresponsible biobanking:
- Biobanking is integral to medical research, treatment, and pharmaceutical innovation, and international cooperation in biobanking is now an integral part of the field. The global biobanking market is projected to grow to US$ 69 Billion by 2028.
- Irresponsible biobanking and use of biological data create apprehensions of data misuse for discrimination or inappropriate attribution of data for unethical innovation and associated fear-mongering, like with “designer babies”.
- However, biological data outcomes are not the only space that requires governance. Data collection, storage, and sharing are precursors to misuse that also require governing and compliance.
Lack of biobanks in the Global South:
- Globally, most biobanks are housed in North America and Europe, covering about 95 percent of the biobanks in the world.
- The Global South is still catching up in this space, hosting approximately 5 percent of the world’s biobanks. India currently hosts 19 registered biobanks of 340 global biobanks, with many others yet to be globally recognised in the Global North and Global South.
- The lack of biobanks in the Global South results in an inequitable representation in health research, development, and deployment of health initiatives.
- Further, there is a dissonance in results using samples from the Global South while catering to Global North health requirements.
- Amid the pandemic in August 2021, the World Health Organization built the first global vaccine-manufacturing hub in Cape Town, collaborating with the South African government.
- However, private sector participants like Moderna and Pfizer’s desire to preserve their knowledge reduced the capacity of Afrigen to contribute to vaccine manufacturing. This continued the trend of Africa’s reliance on global vaccine manufacturing, with Africa manufacturing only 1 percent of the vaccines consumed within the continent.
Global guidelines:
- To avoid these inequities in outcomes, the biobanking sector needs greater Global South participation in norm-building and global level governance integrating academic and medicinal research, government outreach, and private-sector involvement.
- Creating such global guidelines for biobanking will include the requirements of the Global South biobanks and health organisations and hold the Global North biobanks, health organisations, and researchers accountable to the sources of data used in their research.
Global conventions:
- Currently, global databases and guidelines overlook some aspects of biological data. For example, organisations like the Global Alliance for Genomic Health, Biobanking and Biomolecular Resources Research Infrastructure, the International HapMap Project, and International Cancer Genome Consortium have established databases and guidelines to encourage ethical data sharing and global access to data from biobanks to propagate innovation.
- Further, to ensure that the Global South has equal access to research results, the Nagoya protocol under the Convention of Biological Diversity outlines biopiracy, its impacts, and the need for equitable benefit sharing.
- This protocol incentivises sustained biological diversity and the utility of biological innovation for human life enhancement.
- For the private sector, too, the International Standards Organisation under ISO 20387 has outlined practices for collecting and maintaining biobank data.
- However, these guidelines and databases are not enforceable and require the voluntary participation of countries and organisations.
- Further, significant gaps in national standards and global compliance ignore the need for equitable data and benefit sharing, barriers to research, biopiracy, and private sector participation.
India and biobanking practices:
- The Department of Biotechnology, under the Ministry of Science and Technology, has outlined best practices for biobanking, ethical data storage, data sharing, and benefit sharing in the Guidelines for Sustaining DBT – Biobanks and Cohorts, Biotech Promotion of Research Innovation through Data Exchange (Biotech – PRIDE Guidelines), and the National Ethical Guidelines for Biomedical and Health Research Involving Humans.
- India is taking the lead in advocating for global governance. Formulating such guidelines and establishing an overlooking authority will help address the dissonance between the Global South and Global North.
- In recent years, India has established itself as a global leader in healthcare with its participation in SARS-Cov-19 vaccine development, deployment, and diplomacy.
- Further, India, with its experience in the Global South dynamics for biobanking and history of exporting health information and data, can also contribute to the need to prioritise diseases that are relevant to the Global South, highlight the need to prevent biopiracy, and establish rules around benefit sharing to the Global South.
India’s outreach in global diplomacy:
- India also has a global platform with its involvement in multilateral organisations like the Quadrilateral Alliance and the G20 presidency.
- India, with its association with the Quad, was able to increase its vaccine production and deployment to over 70 countries by 2022.
- Similarly, India has suggested the urgency of a Global Vaccine Research Collaborative, citing its vaccine diplomacy on the G20 platforms.
- With these platforms backing India’s outreach in global diplomacy, it can expand its national regulations to inspire and assist in creating a global governance structure for biobanking and data sharing, thus, providing relief to any lack of trust between researchers and biobanks, and creating mechanisms for benefit sharing and incentives for funding in the Global South.
Way Forward:
- In conclusion, India spearheading this need for governance of biobanking, and representation of the Global South will promote advancement of scientific research, equitable healthcare, mutual benefit sharing, and address the unique healthcare challenges these regions face.
