EU data protection legislation
Personal data, such as individual patient records, provide a vital resource for research for the benefit of society and saving and improving the lives of patients.
Proposals for an EU Data Protection Regulation
In 2012, the European Commission proposed a comprehensive reform of data protection rules that would harmonise across EU member states the laws governing the use of personal information. This draft Data Protection Regulation will affect how patient data are used in research, and so the MRC and stakeholders including the Wellcome Trust have been working together throughout the EU decision-making procedure, to ensure the implications for research were understood and that the new regulation facilitates research while protecting participants.
In December 2015, the European Commission, European Parliament and the Council of the European Union reached informal political agreement on the text of the Data Protection Regulation, and they are expected to formally agree it in the first half of 2016. Once formally agreed the Regulation will come into force within in two years. The MRC welcomes the current text, which includes important provisions to support research. We will continue to work with the UK Government and other stakeholders throughout the implementation stage to support research.
Background: Concerns around amendments adopted by the European Parliament
The MRC, along with other major European research organisations, welcomed the original text of the Regulations, which set out a mechanism for protecting privacy while enabling research. This included a requirement for specific and explicit consent for the use and storage of personal data, while providing an exemption for research, subject to strong ethical and governance safeguards.
However, in October 2013, the Civil Liberties and Home Affairs (LIBE) committee of the European Parliament adopted amendments that would have severely restricted the use of personal data for scientific research purposes without specific consent. The MRC’s concerns around the impact of these amendments were set out in a joint statement from non-commercial research organisations and academics, published in March 2014. In the currently agreed text of the Regulation, many of these identified areas of concern have been addressed.
- EUDPR position statement from academic, patient and non-commercial research organisations December 2015
- Open letter to The Times Published November 2015. Signatories include MRC CEO Professor Sir John Savill
- Wellcome Trust information on data protection legislation – including previous joint statements and briefing documents (Wellcome Trust website)
- Open letter: Data protection and medical research: Striking the right balance (Contexte website) This letter was also published in The Times on 29 January 2014
- Amendments to European Data Protection Regulation will damage medical research, warn science organisations (Press release, 29 January 2014, Wellcome Trust website)
For more information, please contact: Rosa Parker, Corporate Information and Policy Manager firstname.lastname@example.org