Overview of access rules to Biobanks in The Netherlands

Although there are no specific rules and regulations on biobanks, access to biological samples and data in the Netherlands is regulated by several laws and codes of conduct. Following, a short overview of the applicable rules and regulations, from general to specific.

Biobanks have to comply with the EU General Data Protection Regulation (GPDR). as they 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. The BBMRI- NL offers an elaborate online FAQ on how the GDPR applies to biobanks, collections of human samples and associated health data, which can be accessed on the following location.

The Dutch adaption to the GDPR is the Uitvoeringswet Algemene Verordening Gegevensbescherming (UAVG), text in Dutch. The national supervising authority on the proper implementation of data protection is entrusted to The Dutch Data Protection Authority (DPA), which is entrusted with the supervision on processing of personal data in order to ensure compliance with the GDPR and the UAVG. English background information on their supervisory role can be found on their website.

Other European laws also applicable to Dutch biobanks are described in the section Biobanks in The Netherlands.

Also, the Medical Treatment Contract Law (WGBO) is applicable in the light of biobanks, as it states that participants in medical research must be adequately informed on the research conducted and that permission is needed for access to their data. Furthermore, the WGBO regulates research with human material for further use. The WGBO is an integral part of the Dutch Civil Code and can be accessed here (text in Dutch).

The Law on Medical Scientific Research on Humans (WMO) regulates medical-scientific studies in which humans participate: see here (text in Dutch). For the WMO to be applicable to a specific biobank, there has to be a prior study protocol in place. As this is not the case for most biobanks, the WMO is often formally not applicable to biobanks. In such cases (where the WMO is not applicable), local review committees developed their own guidelines for biobanks with criteria inspired by the WMO and the Federa Code of Conduct for Responsible Use (see below).

The Authority over Bodily Material Act (Wzl) is a future law on the collection and usage of human tissue and other bodily materials directly applicable to biobanks. This act has been under construction by the Dutch Parliament since 2004 but has not been implemented yet.

The Human Tissue and Medical Research Code of Conduct for responsible use is a self-regulatory code of conduct, developed by the Federation of Dutch Medical Scientific Societies (FDMSS). It aims to regulate professional biomedical conduct regarding secondary use of tissue and cells and ‘de novo’ biobanking. An English version of the Code of Conduct can be accessed here. (A new and updated version of the Human Tissue and Medical Research Code of Conduct is being drafted at this moment. Please make sure you consult the latest version)

Lastly, the Code of Conduct for the Use of Data in Health Research.
This Code was developed in 1995 and was revised in 2002-2003 on the basis of the European Data Protection Directive and its implementation in the Dutch Act on the Protection of Personal Data. The new Dutch version and English translation became available in 2004, you can find in on the following location. An explanatory report in English can be downloaded here.

The following legislation only applies under specific circumstances

The Embryo Act (EA) considers the specific conditions for scientific research on gametes, embryos, and embryonic material. The legal text can be accessed here (text in Dutch).

Similarly, the Foetal Tissue Act (Wfw) regulates the conditions for the research of foetal tissue after spontaneous abortion or abortion provocatus. The legal text can be accessed here (text in Dutch).

The Law on Organ donation (WOD) regulates the specific conditions for organ transplantation and the use of transplantation-organs for scientific research, see here (text in Dutch).

The Blood Provision Act (WiB) regulates the quality, security and availability of blood and related materials. The legal text (in Dutch) can be accessed here.

Also the Disposal of the Dead Act (WLB) can be of relevance, as it regulates the conditions under which medical-scientific research on deceased individuals is allowed. The WLB can be accessed here.