Stakeholder Recommendations on Shaping Human Biospecimen Banking Governance in Pakistan

Abstract

Standardized biospecimen banking is foundational for biomedical research and eventually underpins population health outcomes. In many low- and middle-income countries (LMICs) biobanking remains fragmented and weakly governed, limiting both scientific value and public trust in the ensuing research. This commentary presents insights from a stakeholder dialogue at a national pathology conference in Pakistan. The discourse identified drivers of human biospecimen banking fragmentation and governance gaps in the country, while mapping out contextually appropriate harmonization opportunities. Participants comprised national and international biobankers, clinicians, laboratory directors, bioethicists, and researchers. Key themes were identified through synthesis of participant inputs. A failure to recognize biospecimen banking as a core health research infrastructure across institutions and stakeholders was identified as a major barrier to biorepository science development in the country. This misapprehension deprioritizes national or institutional infrastructure planning, with reliance on short-term research funding for sustaining any biospecimen banking activity. The state of affairs has created siloed biospecimen collections with variable quality and limited sustainability. Regulatory oversight has followed suit with significant gaps in ethics, quality standards, and data governance. Stakeholders proposed a network-based, practitioner-led governance model as a pragmatic first step toward harmonization, enabling shared standards and capacity building in the absence of immediate legislative reform. Given the strong overlap between the science and practitioners of molecular pathology and biospecimen banking in Pakistan, incubating the field within the Association of Molecular Pathology of Pakistan was considered a practical interim solution. With very few dedicated biobanking professionals in the country, a standalone, dedicated biobanking organization is currently non-viable, but the network may transition to one as the discipline matures. The proposed model is grounded in the Pakistani context, though elements of this approach—particularly practitioner-led coordination and stepwise standardization—may be relevant to other LMIC settings with similar resource and governance constraints.