Biobanks under Belgian law

Biobanks, which harbour immense biological resources, are a driving force in medical research for genomics and personalised medicine. However, EU law is silent on the use of human corporal material for scientific research, leaving Member States to regulate this matter themselves. This article aims at presenting an overview of how this matter is addressed in Belgium. Aside from Belgium, only France, Norway and Denmark have specific legislation or regulation concerning biobanks¹.

Legal background

The Act of 19 December 2008 on the procurement and use of human corporal material intended for human application or scientific research (“the Act”) provides provisions on human corporal material (“HCM”) in two very different contexts: (i) HCM intended for human application and (ii) HCM intended for scientific research. HCM intended for human application is already extensively harmonized at EU level in accordance with Directive 2004/23/EC and its implementing directives² and with EU Directives and Regulations on medicinal products and medical devices. There is however a lack of harmonization at EU level when referring to the use of HCM for scientific research. Although the Act does contain provisions on biobanks (provisions relating to the use of HCM for scientific research), these do not implement EU rules but they set up mere national rules. Nearly a decade has passed before the provisions of the Act on biobanks entered into force, after several amendments of the Act, and the adoption of a Royal Decree of 9 January 2018 on biobanks (“Royal Decree”). Both the Royal Decree and the provisions of the Act concerning biobanks have entered into force on 1 November 2018.

Key definitions

Human corporal material

HCM is defined in the Act³ as any human biological material, including tissues, cells, gametes, embryos and foetuses as well as substances which are extracted from them and regardless of their degree of transformation, except for substances which are not of a human nature⁴. Hair, nails, urine, breast milk, faeces, sweat, tears as well as blood and blood-derived products are also included where the procurement, storage and distribution are performed by a biobank⁵. HCM taken in the framework of a clinical trial does not fall into the scope of the Act, except where it is intended or used for other purposes than the trial⁶.

Biobank

The Act lists four type of structures to which HCM can be transferred after having been taken. The only relevant structure for HCM intended for scientific research is the “biobank”, which is defined as a structure that procures, processes, stores and makes available [HCM] (and as the case may be data related to the HCM and the donor] exclusively for scientific research purposes, without any human application⁷. Biobanks are also the only entities through which HCM intended for research purposes can be imported in, or exported from, Belgium⁸. Where an HCM has followed the route of the biobank it can never be used for human applications⁹. Biobanks can be established by public or private entities¹⁰, which means that a pharmaceutical company or an IVD manufacturer could set up their own biobank.

Requirements for the establishment of Biobanks

Setting up a biobank requires a prior notification to the Federal Agency for Medicines and Health Products¹¹ and positive opinion of an ethical committee¹² concerning the purposes and activities of the biobank¹³. It is important to note that once obtained a positive opinion can still be adjusted or withdrawn at a later stage should the biobank not comply with its declared purposes and activities¹⁴. The biobank must thus submit two-yearly reports on its objectives and activities, which contains an overview of the HCM in the biobank and that which has been made available (and its destination) during those two years¹⁵.

The functioning of Biobanks

Traceability of the HCM

“Traceability” is defined as the ability to locate and identify HCM at any step of the process, from procurement to storage, for use or destruction, including processing, control and storage¹⁶. Whether HCM is traceable depends on the consent of the living donor or the decision of the competent medical doctor when the donor is deceased¹⁷. If HCM is traceable, personal data associated with the HCM must be coded in accordance with the Act and the Royal Decree¹⁸ and traceability must be guaranteed at all times unless the donor consents to waive the traceability of the HCM¹⁹. Personal data stored in the biobank may not be kept for more than 50 years²⁰.

The manager of the biobank

The key individual in the biobank is the manager of the biobank who must be a medical doctor if the biobank procures, processes or stores traceable HCM (otherwise it can be either a medical doctor or a pharmacist²¹). Any change of manager in the biobank must be notified immediately to the Belgian Federal Agency for Medicines and Health Products.

The manager must ensure:

• that the HCM supplied to the biobank is used in accordance with the “informed consent form" given by the donor as well as any other rights on information that the donor may have²².
• that the objectives and activities which are reported by the biobank every two years are complied with²³.
• to properly keep (and make available for inspection by the authorities) a register containing the origin, destination and nature of the HCM which the biobank stores and makes available²⁴.
• the traceability of traceable HCM ; If personal data are processed by the biobank, the manager is qualified as a “controller” for such processing under the GDPR²⁶.
• the setting up of a procedure in case the biobank’s activities are discontinued²⁷.

Contract with the recipient of HCM

When HCM is made available by the biobank, a written agreement must be entered with the recipient²⁸. The Royal Decree clearly underlines what this agreement must contain²⁹.

¹ Act No. 12 of 21 February 2003 relating to biobanks (Norway); Public health code as consolidated on 1 November 2019, Book II: Donation and utilization of human corporal components and products (France); Act No. 1202 of 14 November 2014 on health and Act No. 593 of 14 June 2011 on research ethics review of health research projects (Denmark). (Free translation)
² Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells; Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells; Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells; Commission Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells; Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells.
³ Art. 2 °1 of the Act.
⁴ For instance, viruses are substances which are not of a human nature and which do not fall into the scope of the definition of HCM even where they have been extracted from human cells.
⁵ Art. 3 § 3 e) of the Act.
⁶ Art. 3 § 3 f) of the Act.
⁷ Art.2 °27 of the Act.
⁸ Art. 8 § 1, 7° of the Act.
⁹ Art. 8 § 2/1 of the Act.
¹⁰ Art. 1°1 of the Royal Decree; however, only specific hospitals will be allowed to receive, store and make available gametes, embryos and foetuses.
¹¹ Art. 22 §1 of the Act; art. 3 of the Royal Decree.
¹² As specified in the Belgian law of 7 May 2004 on experiments on the human person.
¹³ Art. 22 §1 of the Act.
¹⁴ Art. 7 of the Royal Decree.
¹⁵ Art. 6 of the Royal Decree.
¹⁶ Art. 2 °27 of the Act.
¹⁷Art. 22 §4 of the Act. However, this is without prejudice to the provisions of the Act of 7 May 2004 on experiments on the human person.
¹⁸ Art. 22 §5 of the Act; art. 8 of the Royal Decree.
¹⁹ Art. 11, 22 §7 of the Act.
²⁰ Art. 22 §8 of the Act.
²¹ Art. 22 §3 of the Act.
²² Art. 10 §5, 11, 15 §1 and 22 §3 of the Act.
²³ Art. 15 §1 of the Act; art. 6 of the Royal Decree.
²⁴ Art. 22 §2 of the Act; art. 9 of the Royal Decree.
²⁵ Art. 22 §§4-5 of the Act; art. 11 of the Royal Decree.
²⁶ Art. 11 of the Royal Decree.
²⁷ Art. 17 §1/1 of the Act.
²⁸ Art. 10 §1 of the Royal Decree.
²⁹ Art. 10 §2 of the Royal Decree.