6. Biological Specimen

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment.

Belgium has a complex regulatory framework for biobank research and its interplay with the data protection rules.

There is the Law of 19 Dec 2008 regarding the acquisition and use of human bodily material destined for human medical applications or for scientific research, hereafter the “Law of 2008 on HBM”.

The sampling and operations carried out on Human Bodily Material (HBM) in the context of clinical trials on medicinal products of human use, are excluded from the scope of the Belgian Law of 2008 on HBM.

However, the Belgian Law of 2008 becomes applicable to data and samples collected in the scope of a clinical trial if they are later used for other research (i.e., secondary use).

In 2009, the Belgian authorities released the Royal Decree on 28^th Sept 2009, which sets the quality and safety standards for the donation, collection, obtaining, control, storage, and distribution of human bodily material. Chapter VI and Annex 3 of the RD 28 Sept 2009 provide clarification on the requirements for collection and export.

The Royal Decree of 9 January 2018 (which entered into force on 01 Nov 2018) on biobanks regulates the operation of a biobank in the context of operations carried out with human bodily material for scientific research.

In pursuance of shed clarity as to how to interpret and implement the complex system of legal requirements, the FAMHP set up a working group to facilitate its implementation. The result was the “Compendium” in which experts from different organizations answered a series of frequently asked questions from the professionals concerned.

The “ Compendium ” addresses the following themes:

1. Scope of the Act, Import, Export, Clinical Trials, Derivatives
2. Coming into Force and Historical Samples
3. Notification procedure
4. Exchange of samples, contract and framework agreement, register
5. Consent
6. Removal of human bodily material
7. Traceability and anonymization
8. Donor Information
9. Biobank Manager
10. Compensation
11. Ethics Committee

The requirements for exporting shipping biological samples will depend on the context, type, and use of the examples themselves. Therefore, it is recommended to discuss with the FAMHP (biobanks@fagg-afmps.be) as well as with the Central Labs involved to assess the export requirements.

6.2 Does local regulation require any separate consent for biological specimen collection, storage, and future research? If yes, please explain if there are any templates and/or links to be followed.

No, it does not need separate consent (unless it is for a sub-study). Information on biological collection can be included within the main participant information sheet.

The ICF template provides options for the required information to be included for those cases when biological specimen collection will take place during a study.

6.3 Does the local authority require any specific documents for customs clearance?

Yes, it will depend on where the samples will be shipped to. 

The European Commission has some information on customs clearance documents and procedures that may be useful.