The new Belgian Royal Act of 9 January 2018 on Biobanks will apply on 1 November 2018. The Royal Act implements Article 22 of the Belgian Law of 19 December 2008 on the procurement and use of human body material for human medical applications or for scientific research purposes.
Scope and requirements
The biobank legislation applies to any structure which stores and makes available human body materials for the purposes of scientific research. However, researches with human medical applications are excluded from the scope of the legislation.
The term human body material is defined broadly and includes “human tissues and cells, gametes, embryos, foetuses, and any derived substances”.
In accordance with the Belgian legislation, biobanks must comply with a number of requirements. This includes:
- Obtaining a positive opinion from an ethics committee in relation to their objectives and activities;
- Notifying the Federal Agency for Medicines and Health Product (hereafter “AFMPS”) for their activities;
- Maintaining a register of human body materials;
- Entering into detailed agreements in relation to the sourcing and supply of human body materials;
- Appointing a medical doctor or a pharmacist for the administration of the biobank;
- Ensuring the traceability of the human body materials.
Any entities falling within the definition of a biobank must notify their activities with the AFMPS before 1 November 2018. However, biobanks which were operating prior to 5 February 2018 have until 1 May 2019 to notify the AFMPS. Unfortunately, this “grace period” only applies to the notification requirement with the AFMPS. Biobanks must comply with the other requirements laid down in the biobank legislation by 1 November 2018.