Proposed changes to the EU’s update of data protection could be bad for research

Posted on March 26, 2013 by

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AMRC has joined medical research funders to support a statement on proposed changes to the EU law governing the use of personal data, explaining why the Rapporteur’s proposed changes are bad for medical research and how the Regulation can best support research.

The Regulation is currently on its way through the European Parliament. The Rapporteur has suggested some changes that would limit and even prevent a lot of health research accessing patient data that is currently underway in the UK.

Our joint statement directly addresses these changes and the impact they will have on research, making calls on Ministers and MEPs to:

  • Retain the provisions that support scientific research
  • Clarify the definitions and scope of the Regulation
  • ensure that the use of pseudonymised data in scientific research is handled proportionately by the Regulation

The Regulation still has a long way to go in Europe so there are lots more opportunities for the Rapporteur’s amendments to be debated and others to have a say.

Background

Back in January, the EU published its plans to reform the data protection framework across Europe. This includes a regulation setting out a general EU framework for data protection. The proposals in this regulation cover the use of all personal data which includes patient data gathered about people every time they visit an NHS hospital or their GP. Patient data is a valuable resource for health research (for more on how it is used go here) so these proposals will have implications for health research.

The proposals in the Regulation were pretty good for health research. Recognising that access to patient data is valuable for research, it included a “derogation” which provides an exception from some of the requirements of managing personal data when it is being used for scientific research. But there were a few areas where we wanted further clarification of the definitions used and the scope – in particular whether the process of anonymising data and the use of pseudonymised data, where the individual is not directly identified but can be re-connected to their data by a code if necessary, fell within the scope.

To outline our questions and concerns, medical research funders, including AMRC, supported a joint statement on the regulation. There is a summary of what we said here. This was shared with the Ministry of Justice who is leading the UK’s input into the Council of Ministers and the MEPs sitting on the Civil Liberties, Justice and Home Affairs (LIBE) committee which is looking at the Regulation in detail.

What now?

The Rapporteur leading the European Parliament’s scrutiny of the Regulation recently published his report, recommending changes to the Regulation.  He suggested tightening the derogations which allow data to be used for scientific research. If these proposals came into force, this would stop a lot of research using patient data underway in the UK at the moment.

To address why these changes are bad news for research and recommend how the Regulation could better support research, a new  joint statement has been developed.

This gives some background on how and why data is important to health and social research, including some examples of the research this enables, and public opinion on patient records being used for health research. It then outlines the impact the proposed changes would have on scientific research and makes some clear calls:

The Regulation as originally drafted strikes a good balance between protecting people’s confidentiality and helping researchers to access data to improve healthcare.

Retain the derogations for scientific research

The Rapporteur has proposed amendments to Article 81 and 83 that would restrict the use of personal data for scientific research purposes without specific, informed and explicit consent. In practice this would stop many research projects which rely on a broader model of consent. The statement outlines the extent of this impact.

Clarify the definitions and scope of the Regulation

We need to be very clear over which types of data fall within the scope of the Regulation. The regulation covers ‘personal data’ but we need a tight definition of what counts as ‘personal data’ so we can be clear how we should handle different types of data.

In particular, ensure that the use of pseudonymised data in scientific research is handled proportionately by the Regulation

The regulation is not very clear over whether pseudonymised data are intended to be included. Pseudonymised data is where the individual is not directly identified but can be re-connected to their data by a code if necessary, perhaps to update their record in a registry with new information or, if their tissue has been collected, to enable a researcher to access data on the samples when they study them. The Rapporteur’s amendments would include pseudonymised data in the scope of the Regulation; this would massively increase the regulatory burden on using it, making it similar to using identifiable data. This could be bad news for projects using pseudonymised data in the UK such as UK Biobank and the new Clinical Practice Research Datalink.

What next?

The Regulation still has a long way to go in Europe – it is going through the co-decision process so both the Council of Ministers and MEPs in the European Parliament must come to agreement on its content before it can become law. So there are lots more opportunities for the Rapporteur’s amendments to be debated and others to have a say.

Here in the UK, the Ministry of Justice – the lead department on the European Council of Ministers – is working closely with the Department of Health to consider the impacts on research and we have shared this joint statement with them.

And in Europe, we are planning a meeting jointly with the Wellcome Trust and the European Foundations Centre to bring together other organisations funding research across Europe to discuss the impacts and how we can work with MEPs to ensure a positive outcome for research as the Regulation progresses through Parliament. Further details will be available soon.

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