The Royal Decree of 9 January 2018 on biobanks, published in the Belgian Official Gazette on 05.02.2018 in implementation of Article 22 of the Law of 19 December 2008 regarding the procurement and use of human substances destined for human medical applications or for scientific research purposes, enters into force on 01.11.2018. The full text can be found here in Dutch & French: Belgian Biobank Law 2018
The Royal Decree on biobanks provides for:
- the procedure whereby the biobank should declare itself to the Federal Agency for Medicines and Health Products, as well as the content of the declaration file;
- rules relating to the harvesting of human substances intended for a biobank;
- the provisions relating to changes to and cessation of the biobank’s activities;
- the manner and frequency with which the biobank reports to the ethics committee and under what conditions the ethics committee can amend or withdraw its opinion;
- the data that the register held by the biobank should contain;
- the content of the agreement between the biobank and the recipient of the human substances;
- the procedures relating to donor encoding, traceability and identification.
In 2022, an update has been published, which can be found here: Belgian Biobank Law update- Febr 2022
In order to shed clarity as to how to interpret and implement the complex system of legal requirements, the Federal Agency for Medicines and Health Products (FAMHP) developed the Compendium. During the preparation of the Compendium, the input of relevant stakeholders was sought, namely representatives of academic and industrial biobanks, ethical committees and juridical experts. By providing answers to 47 consolidated questions, the document covers a broad range of topics such as, inter alia, the scope of the biobank legislation, consent, notification procedure, transformation of HBM, traceability and anonymization, ethics committees. The full document is available (in NL/FR/ENG) here: Compendium 2018 The Federal Agency for Medicines and Health Products (FAMHP) is currently working on an update of the Compendium in response to the updated Royal Decree published in 2022.
An Overview of Belgian Legislation Applicable to Biobank Research and Its Interplay with Data Protection Rules can also be found in this book chapter: Lalova et al, GDPR and biobanking, Law, Governance and Technology Series (ISBN 978-3-030-49388-2 (eBook)