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.
A biobank is a structure used to store and make available human substances that are intended exclusively for scientific research and under no circumstances for human applications.
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 anticipation of the entry into force of this Royal Decree, you may now request advice from the ethics committee concerning the activities and objectives of your biobank and prepare your declaration file.
If you are already stocking human substances and thus already corresponded to the definition of a biobank on 05.02.2018, you will have to submit your declaration no later than six months after the entry into force of the Royal Decree, i.e. no later than 01.05.2019. Concerning the creation of new biobanks, they must be declared before they are established.