Work to ensure that the European Data Protection Regulation does not prevent important health researchStatus: Ongoing
European Data Protection Regulation
In January 2012 the European Commission issued proposals for a European General Data Protection Regulation. The Regulation is the legal framework on the protection of personal data. It will replace the current EU Directive and covers the use of personal data in research.
In October 2013, the LIBE committee of the European Parliament agreed edits to the Commission's draft that could have had a seriously negative impact on research. The next step was for the Parliament to negotiate a final draft with the Commission and the Council of Ministers. In June 2015, the Council published its position, meaning that these 'trialogue' negotiations could begin.
Scientific research using personal data generates important benefits by improving our understanding of society, health and disease. Currently, researchers are given access to personal data only under strict confidentiality controls.
The Academy has been working 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. This has included the development of joint briefings and statements with UK and European partners.
We are also supporting the European Data in Health Research Alliance, who are drawing attention to this issue through datasaveslives.eu where there is a petition supporting the need for data in research to improve health.
In December 2015, the trilogue negotations concluded with a broadly positive outcome for research - see our news story for more detail.
The Data Protection Regulation was agreed in April 2016, following the completion of trialogue negotiations between the Council of Ministers, Parliament and Commission in December 2015. The Regulation will come into effect from 25 May 2018.
Member States will now need to explore how they implement some aspects fo the Regulation and in October 2016, we signed two statements outlining what they should priorities. One statement was published by European organisations and the other had UK co-signatories. Both are available to download on the right.
In 2015, the Council of Ministers agreed its General Approach, meaning that 'trialogue' negotiations could begin between them, the Parliament and the Commission - with the aim of agreeing a final draft of the Regulation. In December 2015, the trilogue negotiations concluded and the final agreement was broadly positive for research.
Joint statement ahead of trialogue negotiations (2015)
As trialogue negotiations began on the draft Regulation, the Academy signed a joint statement alongside other supporters of medical research from across the EU. Our European network, the Federation of European Academies of Medicine (FEAM) also signed this statement. It is available to download on the right.
Letter to the times
In November 2015, the negotiations of the European Commission, Council of Ministers and Parliament reached the clauses most significant to research. European stakeholders therefore published a letter in the times to stress the importance of using individual data in research and the need for a Regulation that enables this while also protecting the interests of individuals. The Academy's President, Professor Sir John Tooke FMedSci, was a signatory.
In January 2014, the Academy's President signed a joint open letter and the Academy endorsed a joint statement on the Parliament's 2013 amendments.
Letter to The Times
The Academy's President, Sir John Tooke PMedSci, signed a letter to The Times, which was also published in Europolitics. The letter expressed concern about the European Parliament's amendments to the draft Regulation and their potential negative consequences for research. It was signed by over 30 UK and European research stakeholders.
Joint statement on LIBE report
The letter was accompanied by publication of a joint statement that expressed concern at the Parliament's amendments to the Regulation. It particularly notes Articles 81 and 83, which could have a serious negative impact on medical research. The statement can be downloaded on the right.
Ministry of Justice balance of competences review
The Balance of Competences Review has been taking place across government since June 2012. It is examining the balance of competences between the UK and the EU by auditing what the EU does, and how it affects government and the general public in the UK. The Ministry of Justice opened a call for evidence on the balance of competences around information rights in March 2014. The Academy responded to this review in June 2014 to outline our views regarding the EU Data Protection Regulation. A copy of our response is available to download on the right.
Following publication of the European Commission's draft Regulation in 2012, we worked with other UK and European stakeholders to promote the importance of medical research within the Regulation.
FEAM statement on the Data Protection Regulation (2012)
To better build consensus across the medical science community in Europe, the Academy took a leading role in preparing a Federation of European Academies of Medicine (FEAM) statement on the Regulation (June 2012). Earlier in 2012, FEAM and the Wellcome Trust published proposed amendments to the Commission's original Regulation draft.
Joint statement on the draft European Data Protection Regulation (2012)
In March 2012 the Academy endorsed a joint statement from non-commercial UK-based organisations on how the Regulation should facilitate medical research. This fed into a UK Ministry of Justice consultation of the Regulation that helped determine the UK's negotiating position.
During 2013, we continued to work with UK and European partners to ensure the Regulation allows valuables medical research using personal data to progress.
Statements around the LIBE Committee's amendments (2013)
Following publication of the LIBE Committee's draft amendments, before a vote was taken, the Federation of European Academies of Medicine (of which we are a member) and the Wellcome Trust published a joint statement highlighting how the proposals would have devastating consequences for health research.