Access to Biobanks in Belgium
The access procedures differ strongly between Belgian biobanks, making it difficult to establish a general route. Overall, the access rules to Belgian biobanks are governed by the Royal Decree of 9 january 2018 on Biobanks (see next paragraph for a further explanation on the Decree) . Parties that want to obtain and use human body material for scientific research can only do so from biobanks that are registered at the Federal Agency for Medicines and Health Products (FAMHP), the competent authority for medicines and health products in Belgium.
Before samples are made available by a biobank, a written agreement must be concluded between the biobank and the other party (other biobank or end user). This is applicable for both the transfer of human body materials in Belgium and to export thereof. There are two possibilities to come to an agreement: 1) the establishment of a contract, or 2) the establishment of a framework agreement. The general rule is setting up a contract between the biobank and the end user. In specific circumstances, for example in long-term collaborations or frequent use, a framework agreement can be made.
Overview of access rules to Biobanks in Belgium
Contract for sample issuance, contains as a minimum:
- The object of the scientific research for which the human body material is made available. The description of it must be in accordance with the opinion of the ethics committee as to the objectives and activities of the biobank;
- Responsibilities to ensure traceability;
- If personal data (coming from the medical file of the donor) are provided by a biobank when human body material is made available, the description of the appropriate technical and organizational measures;
- In the case where the biobank, following the provision of human body material, communicates personal data to another biobank:
- in the case of living donors, a template of the consent form (with the contents of the consent) is attached to the agreement;
- in the case of deceased donors or residual human body material, the declaration that the legal provisions have been complied with is attached to the agreement.
Framework agreement for samples issuance, contains the following conditions:
- The responsibilities in terms of traceability, data of personal nature and consent are elaborated in a written framework agreement. The researcher must be contractually respecting the obligations of this framework agreement, for example by including them in an employment contract of or in standard procedures of a quality system (SOPs);
- The framework agreement describes, in general terms, the purpose of the scientific research for which the human body material may be made available;
- The manager of the human body material of the biobank records the specific purpose of the scientific research for which each sample of human body material is made available and confirms in writing to the researcher that consent has been obtained for the specific purpose.
The Ethics Committee of the biobank will also have specific requirements regarding the application to ascertain access to biological material. These requirements diver between different biobanks and Ethics Committees. Therefore, the advice is to contact the Committee where you plan to submit your application at an early stage. An elaborate FAQ on access rules and procedures for Belgium biobanks can be found here.
Overview of European and national legislation related to Belgian biobanks
To understand the scope of the applicable laws for Belgian biobanks it is important to understand the Belgian legal definitions of a biobank: A biobank is the structure which, for the purposes of scientific research, with the exception of research with human medical applications, obtains, when appropriate treats, stores and makes available human body material, as well as, human body and donor data if the opportunity arises.
Performing one of these three activities (i.e. obtains, treats, or stores and makes available) with human body material for scientific research is sufficient to consider a structure as a biobank. “human body material′′ is any human biological material, including human tissues and cells, gametes, embryos, foetuses, and substances derived therefrom, and regardless of the degree of their transformation. A good FAQ-style compendium on biobanking in Belgium can be accessed here. Another good overview of some key definition regarding Belgian biobank law, can be found here.
EU General Data Protection Regulation (GDPR)
The EU General Data Protection Regulation is the EU-wide legal framework for the protection of personal data. The objectives of the Regulation are to protect individuals’ rights and freedoms in relation to the processing of their personal data, while also facilitating the free flow of such data within the Union. It provides that the free movement of personal data within the European Union shall be neither restricted nor prohibited for reasons connected with the protection of natural persons regarding the processing of personal data. The official text of the Regulation was published in the Official Journal of the European Union in all official languages on May 4, 2016 and can be downloaded here.
The GDPR is applicable to biobanks, as biobanks collect, store and/or process human biological material, in combination with other forms of personal data, including sensitive data, such as genetic and health data. Further background-information on the GDPR in relation to biobanks can be found here.
The Belgian national GDPR framework law is the 30 July 2018 Act on the protection of natural persons with regard to the processing of personal data. It provides for the implementation of the GDPR’s open clauses. The national framework law can be accessed here.
European Directive No 2004/23/CE from European parliament and European Council, March 31, 2004
This Directive of the Council and the European Parliament sets a number of standards on quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. The Directive 2006/17/EC of 8 February 2006 implements Directive 2004/23/EC of the European Parliament and of the Council regarding certain technical requirements for the donation, procurement and testing of human tissues and cells. Commission Directive 2006/86/EC of 24 October 2006 also implements Directive 2004/23/EC of the European Parliament and of the Council with regards to 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 amends the aforementioned Directive 2006/86/EC with regards to certain technical requirements for the coding of human tissues and cells. Also, Commission Directive (EU) 2015/566 of 8 April 2015 implements Directive 2004/23/EC with regards to the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells. You can access the full text of the Directive No 2004/23/CE here.
Clinical Trail Regulation EU No 536/2014
This Regulation aims to ensure a better level of harmonization of the rules for conducting clinical trials in the EU. It introduces an authorization procedure based on a single submission via a single EU portal, an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, and transparency requirements. It also tries to ease the conduct of multinational clinical trials for pharmaceutical companies, which should increase the number of studies conducted in the EU. Further information on the Regulation can be found here:
The text of this Regulation is found here.
Document of the Council of Europe DH-BIO/INF (2014) 3
This is a working document on the research of biological materials of human origin. It is good to consider this document, but it is not transformed into law (yet). You can access the document here
Belgian Law of 19 December 2008, modified in 2013, on the acquisition and use of human body material for the purpose of medical application to humans or scientific research
The Law of 19 December 2008 on the procurement and use of human corporal material intended for human application or scientific research gives provisions on human corporal material (“HCM”) in two different contexts: (i) HCM intended for human application and (ii) HCM intended for scientific research. HCM intended for human application is already harmonized at EU level in accordance with Directive 2004/23/EC and its implementing Directives and EU Directives and Regulations on medicinal products and medical devices.
Nearly a decade has passed before the provisions of the Law on biobanks entered into force, after several amendments of the Law, and the adoption of a Royal Decree of 9 January 2018 on biobanks (see below). Both the Royal Decree and the provisions of the Law concerning biobanks have entered into force on 1 November 2018. The text of this Law is found on the following location (in Dutch and French)
For further reading on this law, please consider the following links:
Other amendments have been made to the Law of 19 December 2008. These are included in the Belgian Law of 30 October 2018, amending the Law of 19 December 2008 on the acquisition and use of human body material for the purpose of medical application to humans or scientific research. You can access the text of the amending Law on the following location (in Dutch and French).
Royal Decree of 9 January 2018 on Biobanks
The Royal Decree of 9 January 2018 on biobanks implements Article 22 of the Law of 19 December 2008 (see above) on the acquisition and use of human body material for the purpose of medical application to humans or scientific research. This Decree further elaborates the legislation on biobanks and entered into force on 1 November 2018. It regulates the procedure on how a biobank must register with the Federal Agency for Medicines and Health Products (FAMHP) and which elements must be included in a notification file. Furthermore, the Decree gives rules for the removal of human body material intended for use in a biobank, and provisions regarding the modification and termination of biobanking-activities. It also states how and how often a biobank needs to report to the Ethics Committee and under what conditions the Ethics Committee can amend or withdraw an advice. The Decree also regulates the data that must be contained in the register to be kept by the biobank, the necessary substantive elements of the agreement between the biobank and the recipient of HCM, and regulations regarding the coding, traceability and identification of the donor. The Royal Decree is accessible here.
Royal Decree of 31 July 2017
This Royal Decree regulates the import of human substances. In this context, it creates so-called importing establishments, i.e., banks for human substances or production establishments which are authorized by the FAMHP to conclude agreements with third country suppliers for the import from non-EEA countries of human substances intended for human application. This Royal Decree lays down the application requirements and procedures as well as the conditions under which the Minister for Health can withdraw or suspend the recognition of importing establishments. The text of this Royal Decree is found on the following location.
For further reading on this law, please consider the following link.
Overview of Biobanks in Belgium
The "Registers and Biobanks in Transition” strategic initiative is funded by EIT Health