Introduction: In 2023, the Swedish government commissioned the National Board of Health and Welfare with developing the first strategy for organ and tissue donation and transplantation. One of the key ambitions of the 5 year strategy, launched in October 2025, is to establish a clinically driven and equitable tissue service by 2030. To realise this, and to comply with the EU SoHO Regulation, two nationwide measures are particularly prioritised: (1). mapping the national clinical demand for tissue grafts and (2). developing a national tissue information system.
Method: Between April 2023 - April 2025, the National Donation Centre conducted a comprehensive needs assessment of Sweden’s tissue services. The analysis included allogeneic tissues from deceased donors for the purpose of transplantation. Mixed-methods data collection included numerous stakeholder consultations, six national surveys across the healthcare regions, and a two-day conference, which targeted experts and decision-makers from across the tissue pipeline; from donor referral units to transplant centres. An iterative approach was used, allowing initial findings to inform subsequent targeted follow-ups using structured questions to assess operational challenges, information system and national demand for tissue grafts. Findings were analysed for desired outcomes and stakeholder alignment.
Results: Sweden currently lacks a centralised, real-time data system to monitor national demand, current stock levels, and a mechanism for identifying tissue shortages. As a result, it is not possible to determine whether Sweden is self-sufficient, to monitor changes in demand or to make decisions based on clinical national prioritisation. This does not allow for contingency planning. The vast majority of stakeholders consulted in this project support developing a national tissue information system. The system would align with international standards (e.g. EDQM Tissue guide), provide nationwide transparency, enable data-driven decisions and equitable allocation. Due to the decentralized healthcare regional structure, there is currently no national body with mandate that can respond to tissue shortages on a national level. Governance and financing models for such a system are currently unresolved.
Conclusion: A national tissue information system is essential to achieving Sweden’s 2030 goal and to meeting national and EU regulations. Critical to the success of such initiative is to identify sustainable financing models, to determine appropriate ownership and governance structures, and to secure stakeholder buy-in. Along with the collaborative efforts and active involvement of professionals - without which, a clinically driven tissue service by 2030, with equitable access to tissue transplantation, will likely remain unachievable.