The research community has welcomed a vote on the new European Data Protection Regulation, which includes proportionate safeguards on how personal data is used in health research.
Earlier drafts of the Regulation had included amendments which would have had a devastating impact on life-saving research studies. The trilogue agreement comes ahead of votes by the Civil Liberties committee of the European Parliament and Member State representatives, expected to happen in the next few days. A positive outcome to both votes will indicate political agreement between the institutions, ahead of formal votes expected later in 2016.
Some of Europe’s most important medical discoveries, such as establishing the link between smoking and cancer and understanding the relationship between diet and disease, have been made possible by using personal data. Countless lives have already been saved and world-leading European research continues to improve health.
Strong safeguards and governance structures are already used to ensure that personal information is used safely, ethically and securely in research. The text agreed in trilogue discussions enshrines the need for such safeguards and rejects amendments that would have imposed new disproportionate limits on the use of health data in research.
Following formal agreement on the Regulation, expected in 2016, the continued cooperation between Member States, the research community and patient groups will be important in ensuring that the new regulations are implemented in a way that provides clarity and certainty for researchers.
Beth Thompson, Policy Adviser at the Wellcome Trust, said: "We are delighted by the outcome. Europe is a world-leader in health research and the compromise reached by the European institutions is a great outcome for research, which leads to the improved health of people around the world. The vote is an important example of how policy makers have listened to the research community and patient groups and have worked together to find a solution that allows vital research to take place while protecting individuals' privacy."
Emma Greenwood, Head of Policy Development at Cancer Research UK said: "This agreement is important and welcome news. Research is at the heart of our progress in beating cancer, so it’s vital this can continue to help us save more lives. We’re pleased the law has steered away from a damaging course that would have held major studies back by limiting how researchers use personal data in their work. We look forward to seeing the law finalised in the coming months, and thank policymakers for having listened to the concerns of patients, researchers and the cancer community in the UK and across Europe."
Richard Frackowiak Chair of the Medical Sciences Committee of Science Europe, said: "It is good to see that reasoned argument and choices based on population health priorities have led to a good decision. The process has succeeded and the people of Europe have been well served."
Bernard Charpentier, President of the Federation of European Academies of Medicine, 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."