The EU General Data Protection Regulation: How will it impact the regulation of research biobanks? Setting the legal frame in the Mediterranean and Eastern European area

Abstract

On 25 May 2018, the EU General Data Protection Regulation (GDPR) will come into force. As with the Data Protection Directive (95/46/EC), the regulation of biobanks for scientific research will be profoundly affected by this reform. Accordingly, a comparative survey of some of the existing national regulatory frameworks is of value to aid understanding of whether and how EU Member States will need to realign their systems to ensure compliance with the new Regulation. This article provides a comparison of the positions of Member States in the Mediterranean and Eastern European area, focusing especially on the existing regulatory framework on biobanks, the definition of personal and genetic data, the pseudonymization process, the processing of personal data for medical research purposes (and its impact on the right to consent of the individuals involved) and the secondary use of such data. The article concludes that effective implementation of the EU GDPR will represent a decisive catalyst for adaptive harmonization of biobanks regulation in the European framework.