Biobanking in the Asia-Pacific Region: The Challenges of International Biospecimen Sharing

The use of biospecimens is critical for the advancement of health research and biomedical innovation. However, access to well-characterized representative sample sets for global research is challenging due to the internationally fragmented legal, regulatory, and funding landscape for the collection, handling, and sharing of biospecimens and associated data.^1–5 The Science Policy Think Tank, a loosely affiliated group of individuals from industry, academia, and nonprofit entities with interest in science policy issues related to clinical research, has undertaken an effort to address these issues.

In collaboration with leaders of the International Society for Biological and Environmental Repositories (ISBER) Science Policy Committee, RIKEN Center for Integrative Medical Sciences, Ropes & Gray, and the Multiregional Clinical Trial Center of Brigham and Women's Hospital and Harvard (MRCT), the group has been exploring the international landscape for global research with biospecimens and associated data, including ethical and societal aspects.^6–10

An open virtual forum, convened in March 2023, was designed to bring together experts from a range of Asia Pacific countries specifically to discuss the legislation, funding, regulations, and ethical standards that apply to biospecimens and their associated data across the region. This multinational region exhibits sustained technological and research growth, whereas population-level health needs, such as infectious diseases surveillance, continue to exert pressure on public systems.

During the first session of the open forum, Zisis Kozlakidis moderated a discussion with regional experts on the current state of biobanking activities in Malaysia, Indonesia, Singapore, Japan, Vietnam, and China. The experts highlighted the limitations and challenges faced by each country in terms of access to biospecimens and associated data for global research.

Discussants noted the fragmented nature of the biobanking research landscape across the region. In brief, in Malaysia, there are five well-known biobanks that focus on collecting cancer tissues for research purposes, but there are limitations on foreign access to Malaysian biospecimens or associated data due to personal data protection statutes. In Indonesia, biobanking activities are conducted across the country by private organizations, universities, and the government, but there is no register of biobanks operating in the country.

Singapore has implemented the Human Biomedical Research Act of 2015 to govern human tissue banking and has substantial reporting requirements for researchers. Japan has three major biobanks, but biospecimens and associated human data are not sent routinely outside of Japan due to regulatory and privacy concerns. In Vietnam, there are several biobanking projects across the country that focus on a wide range of human diseases, and the ministry of health has encouraged hospitals to develop biobanking operations. In China, although there is no single regulation or law that governs the management and operations of biobanks, stringent ethical and quality management standards have recently been established by the government.

Importantly, although all countries are understanding the power of biospecimens and have made great strides in advancing secondary research using biospecimens and associated data within their bounds, international sharing remains challenging. The variation in standards across countries and regions creates challenges for the use of biological specimens and data, including the transnational shipment of such biospecimens and data. The experts emphasized the need for greater collaboration and harmonization of regulations and standards to facilitate the sharing of biospecimens and associated data for global research.

The second session of the open forum, moderated by Helen Morrin, Curator, He Taonga Tapu Cancer Society Tissue Bank, University of Otago Christchurch, NZ, focused on the importance of diversity and representativeness in biospecimens and the significance of community engagement in the establishment and operation of biobanks. The panelists emphasized the need for researchers and governments to collaborate with community members in a transparent manner, taking into account diverse community beliefs and preferences. Effective collection efforts require consistent community engagement that includes explanations on the benefits of participation, the answering of questions and earned community trust.

Although data integration is a key to leveraging the power of genetic data and to understanding the heterogeneity of the human genome, the panelists also discussed the challenges due to the different approaches various governments take, the importance of preparing for inadvertent disclosure of biological data and the need for taking steps to prevent discrimination as a result of developing and operating a biobank. Strong governance mechanisms within a biobank are needed, can help build community trust, and empower scientists to conduct research. Furthermore, biobanks should work with nongovernmental organizations as a bridge to build a relationship with the community and develop a legacy in the community that goes beyond the individuals whose data and biospecimens are stored in the biobank.

During the wrap-up, Mark Barnes of Ropes & Gray and the MRCT highlighted that research participants generally prefer their biospecimens to be used for constructive medical research rather than being left to languish in storage facilities. However, strong biobanking governance that includes oversight over biospecimen use is crucial. Participant engagement in biobank governance alongside scientists and funders is necessary. The variation in standards across countries and regions creates challenges for the use of biological specimens and data, including the transnational shipment of such biospecimens and data.

Ultimately, the open forum highlighted the need to define shared ethical principles relating to secondary research uses of biospecimens and associated data, and to do so across the “life cycle” of biospecimens. National regulatory regimes and requirements can then be mapped onto these principles, with an ultimate goal of identifying how regulations align with accepted ethics principles and advocating for convergence among national regulations. The full report is available online. ⁶ An initial set of principles have been drafted and presented at in-person and virtual workshops at the 2023 ISBER Annual Meeting in Seattle and will be further discussed at a workshop at the annual meeting of the Public Responsibility in Medicine and Research that will be held in Washington, DC, on December 6, 2023.

In conclusion, the power of biospecimens is immense, and their use is critical for the advancement of health research and biomedical innovation. Although this is increasingly recognized by nations within the Asia-Pacific region, access to well-characterized representative sample sets for global research is challenging due to the internationally fragmented legal, regulatory, and funding landscape for the collection, handling, and sharing of biospecimens and associated data. The international community must work together to define shared ethical principles relating to secondary research uses of biospecimens and associated data, and to advocate for convergence among national regulations. By doing so, biomedical innovation can become more globally relevant, equitable, and sustainable.