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Project [achieved in march 2018]

Regulation of Biobanks in Europe

Status as of March 1st, 2018


This mapping of the regulation of biobanks in selected European countries is the result of a comparative law study funded by the Swiss Federal Office of Public Health and the Institut de droit de la santé (IDS) of the University of Neuchâtel. Its aim is to provide an overview of the applicable laws and regulation related to the governance of health databases and biobanks, as well as to the basic rights (informed consent and data protection) of the participants and to the competent authorities. At this stage, this study covers the regulation of the following countries: Switzerland, France, Germany, Belgium, United Kingdom, Denmark and Norway.

Legal texts and policies are provided for reference purposes only – documents should not be considered official versions. The data are available on a free and open access basis. They are subject to modification while we upgrade and update the quality of the database. You are welcome to contact the authors if you have suggestion to complete or improve the information for a given country or to add the applicable laws and regulation in another country.

Authors: MLaw Vladislava Talanova and Prof. Dr iur Dominique Sprumont.

For more information about the methodology used in this study:

How to get started

  • Adjust the zoom of your screen if you don’t have a full vision of both the questions (left) and the map (right).
  • Use the Explore tab question by question to get an overview of the results of all selected countries.
  • Use the Filter tab to see the results according to a specific question.
  • When you choose a question, a list of countries appears below the map. Under the sign §, you find the relevant provisions for the chosen answer in the given country. To see the full text, please click on the sign §§ in the middle of the box.
  • The sign  indicates the existence of comments clarifying an answer.

Chapter 1: Legislative Framework and Competent Authorities

This dataset presents the applicable laws and regulation related to health databases and biobanks in the selected countries as well as the authorities involved in the establishment and monitoring of biobanks.


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