The Academy has been working to influence the EU Data Protection Regulation since January 2012 and in December 2015, EU negotiations concluded with a broadly positive outcome for research.
The research community had expressed concern that the Regulation might have a negative impact on health research. In particular, the European Parliament’s version of the draft Regulation would have made much health research involving personal data at worst illegal, and at best unworkable. However, the final draft of the Regulation that emerged from negotiations should allow valuable health research studies to continue.
The Academy has been working with the research community, led by the Wellcome Trust, to see a Regulation that strikes an appropriate balance between the safe and secure use of personal data in research and the rights and interests of individuals. Over the past four years, we have supported development of joint briefings and statements with UK and European partners.
Much of this work has been done alongside our European network, the Federation of European Academies of Medicine (FEAM). Responding to the outcome of the negotiations, FEAM President, Professor Bernard Charpentier, said:
‘Personal data is used in health research to make important discoveries, which can save lives. Regulations must balance the use of personal data in research with the interests of individuals. We had been concerned that potential amendments to the EU General Data Protection Regulation could threaten health research studies.
‘However, based on the outcome of the trilogue negotiations, we are optimistic that valuable health research studies will continue and we are pleased that the importance of this research has been recognised. We look forward to assessing the full implications for health research in due course.’
The Regulation is the legal framework on the protection of personal data in the EU. It will replace the current EU Directive and its remit includes the use of personal data in research. A draft was produced by the European Commission in January 2012 and has been passing through the European Parliament and Council of Ministers ever since. Since June 2015, the Commission, Parliament and Council of Ministers have been negotiating a final draft of the Regulation – a process known as trilogue. Their negotiations concluded in December 2015, which means the final text can be voted on and legal checks progressed, so that a final version should be approved in 2016.
For more information on our work on this issue, visit our project page.