Data Protection in Clinical Studies – Implications of the New EU General Data Protection Regulation


The European Commission published in January 2012 a proposal for a regulation setting out a general framework for data protection. The proposal, after adoption, shall supersede the current Data Protection Directive with a revised set of data protection rules that will apply directly across all Member States. Although the Regulation will continue many of the established principles of existing EU data protection law, there are significant changes in key areas that will affect the day-to-day business of companies in the life sciences and health care sectors. The practicality of some proposed changes is in question, and interested parties may wish to engage in the legislative process to ensure that the final draft takes into account the particular industry needs. The following article examines the impact of the proposed changes on clinical trials and their practicality in a global environment.

Background of the Proposal

Data protection in the European Union is currently governed by the EU Data Protection Directive (Directive 95/46/EC, “Directive”) as of 1995 and the various national laws implementing the Directive in each Member State. Rapid technological developments and corresponding challenges for privacy regulation led the European Commission to introduce on January 21, 2012 a proposal for a new regulation governing the protection of individuals with regard to the processing of personal data and the free movement of such data (General Data Protection Regulation, “DPR”). The DPR, once adopted, will replace the existing Directive and the various inconsistent national data protection laws. The DPR will be directly applicable in all member states of the EU without any need of implementation in the Member States. It will provide a comprehensive and consistent EU wide data protection level that provides a uniform data protection regime and a simple but stronger enforcement framework in all Member States of the EU. The proposed regulation will now go through the EU legislation process and is expected to be adopted in 2014. Now is the time for interested parties to actively engage in the discussions on the proposal for the DPR to ensure that the final form takes account of particular needs of the industry and business operations.

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