Data protection ‘trilogue’ must leave room for health research

By European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan

When it comes to data for medical research, the Brussels-based European Alliance for Personalised Medicine (EAPM) and many other stakeholders have been (and are) concerned that the proposed Data Protection Regulation may go too far, be too cautious and have a negative effect on the health of the EU’s 500 million citizens.

The Regulation is designed to update the out-of-touch Data Protection Directive, which when formulated did not consider the massive leaps in technology, the growth of social networks and the expansion of cloud computing, among other issues.

When it eventually enters into force, apart from a two-year transitional period, as a Regulation, rather than a Directive, it will have an immediate effect on all 28 member states and will not need any enabling legislation to be passed by individual governments.

Its implications are huge.

The amount of data available (not just in health, of course) has never been bigger – it will continue to grow – and its uses for research purposes are invaluable.

Meanwhile, science will not stop moving forward, and the use of genetics in personalised medicine, the existence of biobanks and the availability of super computers for data-processing purposes all combine to make the potential for the use of so-called Big Data huge in the arena of health.

Big Data can be used to drive innovation in translational research and health outcomes tailored to the individual - offering the potential to revolutionize the effectiveness of health interventions in what are increasingly cash-strapped public healthcare systems.

Personal health data comes from a multitude of sources including individual patient records, clinical research recruitment, biobanking and patient-generated information: all of these data are valuable in their own way.

Scientists need to be able to work with and test on large datasets. Of course, then there are questions about how best to link these results to clinically meaningful and actionable information, and how to create tailored responses to them. These factors represent further challenges.

Of course, patients (and their personal data) need to be protected with robust safeguards, yet there is also a need for data to be accumulated, shared and made available for research – with the appropriate consent of those concerned.

There is currently a highly vocal debate over a patient’s right to own his or her data, and to be able to get to it whenever he or she wishes, as well as the moral and ethical concerns regarding Big Data’s usage, sharing, storage and more. It’s a practical, moral and ethical minefield.

Stakeholders are looking for a compromise position on these immense topics that are about to be discussed in a ‘trilogue’ between the European Parliament, the Commission and the Council. EAPM believes that any compromise needs to facilitate, rather than hinder, research for the benefit of society.

Broad consent in health research, allowing patients the ability to pass on data for current and future uses within his or her parameters, is vital and EAPM would prefer to see a ‘one-time consent’. This is because going back to a donor time-and-time again for a specific consent in a specific area of research is always impractical and will eventually become impossible after death.

The process that is ongoing saw the trilogue have its first meetings in June and July and, although there is as yet no official ‘road map’, the Parliament’s proposed timetable will see research, as a whole, discussed until November.

In the meantime, a working group of Member States’ data protection authorities has published a paper that says that the “position adopted by the European Parliament seems to set unnecessarily restrictive conditions for the use of personal data concerning health in the context of historical, statistical and scientific research purposes”.

On the downside, it also opposes the inclusion of an independent legal basis for research. Legal certainty and clarity would  be helpful, in the view of EAPM.

The current European Parliament position includes some amendments that threaten to have a serious impact on research if they are finally adopted. Through intense discussions and ongoing meetings – as well as published papers - EAPM is doing its best to have these potentially negative impacts counter-balanced for the benefit of the health of our current population and that of the generations that will follow.

The European Council, meanwhile, has adopted its General Approach and discussions can now begin in earnest with Parliament and the Commission. The texts of the Council and the Parliament currently differ widely and, while agreement on the Data Protection Regulation was never expected until the end of this year, the discussions may well run into 2016.

When we come out of the other side, EAPM hopes that the regulation, while looking after the best interest of patients and their personal data, will not be over protective, but will leave space for continued valuable research that will eventually improve, and often save, the lives of millions of citizens.

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