Risks of the new EU Data protection regulation: an ESMO position paper endorsed by the European oncology community

Abstract

On 12 March 2014, the European Parliament voted on its position on the new European Union (EU) proposal for a General Data Protection Regulation, which will be now negotiated among the European Parliament, the Council of the European Union and the European Commission [1]. The final text will set the rules under which personal data are to be handled in the EU. It will thus affect many areas of our everyday life, including health and research. The cancer community is deeply concerned about unintended consequences of the current wording of the draft Regulation [2], which may put at stake the survival of retrospective clinical research, biobanking, and population-based cancer registries in the EU. In fact, the EU Parliament's recent. Resolution [3] on the Regulation imposes, or may be interpreted as imposing, the requirement for researchers to ask for a patient's ‘specific’ consent every single time new research is carried out on already available data and/or tissues. This would lead to the necessity of researchers continuously asking patients to ‘re-consent’ for every single use of their data. In fact, the European Parliament's Resolution [3], Amendment 191 states that,