Personal data holds huge potential to help us understand health and disease through research. For example, since the 1990s, the European Prospective Investigation into Cancer and Nutrition (EPIC) has investigated the relationships between diet, lifestyle and environment and disease thanks to half a million participants across ten European countries allowing access to their data. EPIC has provided important evidence on the causes of breast and colon cancer and continues to advance knowledge related to cancer and other chronic diseases
The Trust has a long-standing interest in how to facilitate research like this, while making sure data is kept safe. Two years ago the European Commission put forward a proposal for a new Data Protection Regulation designed to bring law on the use of personal data up to date. We expected this Regulation to have a significant impact on research, so we have been following its progress and contributing to discussions from the outset.
The initial draft Regulation proposed by the Commission set out a proportionate mechanism for protecting privacy, while enabling health and scientific research to continue. However, over the summer of 2013, Edward Snowden's leaks about the use of personal data by the US National Security Agency increased concerns about how technology companies and governments use data. In response, the Civil Liberties and Home Affairs (LIBE) committee of the European Parliament supported a package of amendments to the Regulation intended to strengthen protections for data across all sectors. Research has become an unfortunate victim of this reaction, since this package included amendments that would tightly restrict the way personal data can be used in research.
LIBE's amendments to Articles 81 and 83 of the draft regulations have all but removed a vital exemption from specific consent. Projects like EPIC often rely on broad consent – where participants allow researchers to access data for a variety of studies under rigorous governance arrangements – but this type of consent would not be valid under the Regulation. In addition, sometimes it is not practicable to seek consent because the required sample size is so large or this would introduce dangerous bias. Requiring specific consent in almost all cases would therefore make much research involving personal data at worst illegal, and at best unworkable.
If these amendments come into force, society will miss out on the benefits that projects like EPIC have to offer. Privacy and consent are of course vital to properly-conducted medical research, which must protect the people who participate in it by providing data. But though the amendments are designed to protect these people, there are other, better ways of achieving this that do not interfere with important research. A rigorous regulatory and governance framework for research already exists, enshrined in national and international laws, and researchers follow guidance built on strong ethical principles. The LIBE amendments to Articles 81 and 83 would add further disproportionate rules – preventing legitimate and life-saving research – that would benefit no-one.
The Regulation is still going through the complex European legislative process and there is still time to make sure that these amendments are not passed into law.
This is why we have coordinated a letter [PDF 75KB] and joint statement from research organisations and academics across Europe setting out our concerns and calling for action. The letter has been published in the Times (paywall) and in Europolitics and urges the European Commission and the Council of Ministers, where the EU Member States provide input, to take steps to ensure that the European Union doesn't get this legislation "dangerously wrong".
It is not clear when this piece of legislation will be finalised or how it will be affected by the European Parliament elections in May. However, while the Regulation is under discussion, our work will continue to seek to ensure that the law reflects an appropriate balance that protects the interests of individuals while enabling research that benefits all society.