Samples that are excluded from the biobank law and are therefore not collected in a biobank are:
- Samples collected for treatment of patients (cell therapy, transplantation,…). These samples are stored in the recognized tissue bank of the hospitals.
- Samples collected in the framework of a clinical study. Human material collected within clinical trials with medicines (EUDRACT studies) or trials in which medicines are compared to medical devices, is excluded from the scope. This means that there are no additional requirements when the material is collected and used as described in a clinical trial application approved by the FAMHP and an ethics committee. However, if the human samples collected within clinical trials are used for a purpose other than what was provided in the approved dossier, they fall again within the scope of the Human Material Body Law and must be transferred to a biobank.
- Samples collected and used for the routine validation of a device or maintenance of at test. If this would concern a new test or diagnostic procedure, the legislation on biobanks applies.
A less severe regime exists for “transformed material”. More details about this can be found in the updated Royal Decree on biobanks from 2022
More detailed information about the which samples should (not) be registered can be found in the Compendium, a document developed by the Federal Agency for Medicines & Health Products (FAMHP) with the most frequently asked questions about the Biobank Law. The compendium is currently being updated to account for the updated Royal Decree that was published in 2022.
In case of any doubt, we advise you to contact the biobank linked to your institution or to get in touch with the coordination office of BBMRI.be