The new Royal Decree on biobanks was published on 5 February 2018 in the Belgian Official Gazette. A biobank stores human tissue and makes it available for scientific research only (that is, not for human use). The decree, which implements the Law of 19 December 2008 in relation to obtaining and using human tissue in human medical applications or in scientific research, determines among other things:

  • The notification procedure to the Federal Agency for Medicines and Health Products (FAMHP) and the required contents of the notification dossier.
  • The requirements under which a biobank may collect human tissue.
  • The requirements for reporting to the ethics committee.
  • The conditions under which the ethics committee may amend or withdraw its opinion.
  • The information that the biobank must maintain in its register.
  • The agreement between the biobank and the receptor of the human tissue.
  • The rules regarding the codification, traceability and identification of the donor.
  • The provisions regarding the amendment or termination of a biobank’s activities.

The decree enters into force on 1 November 2018. Biobanks that are already established on the date of publication of the decree must notify the FAMHP by 1 May 2019 at the latest. Biobanks established after 5 February 2018 must submit a notification prior to their establishment. The FAMHP has published a press release, encouraging biobanks to seek guidance from ethics committees to prepare their notification dossier.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, February 2018 issue (Thomson Reuters).