Sweden's new Biobank Act (2023:38) introduces a more coordinated and robust legal framework for research using biosamples. This article presents the major changes introduced by the Act, as well as insights from regional biobank coordinators who ensure coordination, compliance, and access to biosamples for research and key stakeholders in the research infrastructure. The article highlights both the law's potential and the practical challenges of its rollout in a decentralized health care system, particularly regarding information technology systems, patient information and consent, and procedural harmonization. We discuss how diverging legal frameworks across European Union (EU) member states and internationally can both enable and hinder collaboration, particularly in the context of biobank responsibility and consent structures. The experiences from implementing the new Biobank Act in Sweden underscore the need for timely planning and coordination among stakeholders to enable research on biosamples, improve digital tools, and achieve legal clarity-elements that are equally relevant across the EU and beyond. Ultimately, enabling seamless collaboration requires a shared commitment to harmonization, not only in policy but also in practice.
Johansson et al. (Fri,) studied this question.