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The three main cancer charities and the cabinet of the Minister of Health in Belgium have requested the Belgian Health Care Knowledge Centre KCE to prepare a roadmap for the development of academic cell therapies in Belgium, with a focus on legal aspects.

Before implementing a concrete roadmap, they published a report on the roadmap ‘pre-conditions’, exploring the legal and organizational strategy for the academic development of ATMPs in Belgium.

Four research questions are addressed:

1. What are the current landscape and the current manufacturing capacities for ATMPs in Belgium? (Chapter 1 & 2 )
2. What are the authorization routes for ATMPs, and what legal challenges and potential improvements exist for Academia? (Chapter 3)
3. What are the emerging examples of academic, non-profit, or socially responsible pathways for ATMPs, and what are the key drivers and lessons learned from these case studies? (Chapter 4)
4. Which legal and strategic options can be explored to support academically developed ATMPs in Belgium, with the goal to promote patient access to safe, high-quality therapies with a clear clinical benefit? (Chapters 5 & 6)