Biobank legislation is not harmonised at the European Union level, and the Member States have taken considerably divergent approaches in how they regulate the field. Whereas some countries do not have specific regulations, others have adopted complex biobank laws.
This episode of ELSI Dialogues aims to present the unique legal framework for biobanking that is currently in place in Belgium. The Belgian Biobank law was first adopted in 2008, entered into force in 2018 and underwent an important reform in 2022.
Moreover, the law is complemented by an essential piece of self-regulation, namely the Compendium on biobanks issued by the Federal Agency on Medicine Products and Health. The interplay with relevant data protection rules will also be the focus of our discussion.
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