Data Protection in Biobanks ¿ A European challenge for the long-term sustainability of Biobanking

Abstract

The paper focuses on several interdependent key issues which encompass the core legal and socio-legal aspects of data protection and biobanking. We also try to highlight a need for the analysis of the impact of the EC Data Protection Directive on biobanks in Europe. An inconsistent application of the Directive is expected to severely affect cross-border research and multi-centre studies and, indirectly, the achievement of public health goals and innovation. Both the European Commission (EC) and the Member States try to facilitate this new research direction of biobanks. In most European countries biobanks are set up to improve the capacities for research. These new research infrastructures require a specific governance framework to ensure public trust and accountability. On a European level, the EC Data Protection Directive is the most prominent regulation which touches the core of the biobanking activities, and administrates the linking and sharing of sample and secondary data. On a national level several Member States have already finalised specific laws on biomedical research or biobanks. The Joint Research Centre ¿ Institute for Prospective Technological Studies (JRC- IPTS) and a recent study on data protection by the Network of Competent Authorities of the Health Information Strand of the Health Directorate of the EC suggested that biobanks suffer from a substantial lack of harmonisation, or rather a harmonised interpretation of the Data Protection Directive, which retards the further progress of Europe. Data Protection is the core regulatory instrument which serves both the protection of privacy and the access to information / data sharing. Data protection is widely mentioned as the most important obstacle to cooperation in the field of biomedical research. For the fields of biobanking and pharmacogenomics it should be assessed whether the research community, funding agencies or research ethics committees, are misinterpreting the legal framework. These uncertainties surrounding data protection and the proper scope of legitimate research exemptions could be detected as the key barrier while unsolved problems in the fields of information property rights and intellectual property rights are still underrated. Several EU funded projects have been set up to help biobanks in Europe to understand the barriers of data protection. There are also attempts to facilitate communication between the research community and scholars from ethics and law as it will increase the capability of ethics committees and policy makers to strive for a concordance between fundamental rights (privacy) and the public good (research).JRC.DDG.J.2-The economics of climate change, energy and transpor