Data protection talks must make special case for research

By European Alliance for Personalised Medicine Executive Director Denis Horgan 

The Data Protection negotiations are currently in full swing within the ‘trilogue’ of the European Council, Commission and Parliament. The Brussels-based European Alliance for Personalised Medicine (EAPM) and many other stakeholders are concerned that the proposed Data Protection Regulation may go too far, be too cautious and thus block the carrying-out and sharing of vital medical research.

This would have a huge, negative knock-on effect on the well-being of the EU’s millions of citizens. We are in dangerous territory for the future of health. It is clear that patients believe it is vitally important to share their data for research. And there are already solid and effective safeguards in place to protect the public in these circumstances, including the obligation to submit usage to ethics committees.

It is a misconception that it is impossible to keep personal data safe - and for a long time, too - while still allowing its use for medical research purposes. It has been used in research for decades and the reasons for its storage have nothing to do with what the EU fears the likes of Google and Facebook may use it for.  To throw medical data into a catch-all protective blanket is to completely miss the distinctions and, therefore, the whole point.

Whenever they can, researchers will ask consent before using personal data. But sometimes consent cannot be sought in practical terms. For just one example, a study might involve thousands of people on a pan-European scale, and getting hold of them all to ask for their consent throws up serious logistical problems. And what if they have died? Do we throw away all this valuable data stored down the years, thus ignoring the needs of 500 million potential patients across 28 member states?

Take the fact that the European Longitudinal Study of Pregnancy and Childhood (ELSPAC) works hard to understand more about child health, and deals with more than 40,000 children, as well as their families, across Europe. It’s a World Health Organization innovative and has collected a great deal of data via questionnaires.   All the participants have given a broad, rather than specific, consent for this data to be shared for research. The problem is that the European Parliament is looking to restrict the use of pseudonymous data ‘without specific consent’ and this would mean ELSPAC (and/or another body working in similar ways) would be required to contact each data donor individually. Imagine the time and cost. It’s just not feasible, so ‘bang!’ goes that research opportunity.

Another example could be, for instance, a collaborative prostate cancer study using a massive data set for cancer research to investigate inherited risk factors. The use of new tools, alongside such huge data mining, are already allowing scientists to work out how likely it is that a given person will develop prostate cancer from their genetic make-up. This is preventative personalised medicine at its finest.

Unfortunately, with this pseudonymous data, Parliament would have researchers demonstrate that studies couldn’t “possibly be carried out” without it and are in “high public interest”. How does one prove that? How can one possibly know what major value the research may have in the near-future or, indeed, farther down the line? Incidentally, for such a study, the use of anonymous data is out because there is a need to link data about people from different data sets.

So, there is much to think about, but it really shouldn’t be as confusing as it may sound. This despite the fact that more than 4,000 amendments have been tabled in connection with this one piece of legislation.

A little background: The Regulation and the ongoing talks surrounding it are designed to update the out-of-touch Data Protection Directive, which originally failed to 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 (because it is a Regulation, rather than a Directive) it will have an immediate effect on all 28 EU countries and will not need any enabling legislation to be passed by individual governments.

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. Those involved in trilogy discussions need to note that 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 revolutionise the effectiveness of health interventions in what are increasingly cash-strapped public healthcare systems.  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’.

As alluded to earlier, 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. While the Commission appears to understand the need for rules to allow for research in the EU, the European Parliament has been less supportive.

Its position included 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.   The texts from the Council and the Parliament originally differed 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.

EAPM has argued, and continues to do so, that the Parliament’s version, which appears to envision only two types of data – personal and anonymous – could seriously jeopardise health research. This is because data used in health research often contains indirect identifiers.

This summer, however, the Council of Ministers tabled its own version – a much more research-weighted proposal in which further use of personal data is not viewed as being incompatible with the original use for which the data were processed.   Under this proposal, broad-based consent would be allowable, while any research taking place without consent would be left to Member States’ own legislation.  And as it stands, any research based on registries of millions of patients would need the informed consent of every single patient.

Apart from anything else, this makes a mockery of calls to reduce waste in research regulation and management, as well as initiatives focused on responsible sharing of individual data linked to clinical trials.   Generally speaking, patient organisations (as well as researchers) much prefer the Council proposals, with surveys suggesting that most patients are happy to share their data for certain types of research – as long as trust is there.  Solutions clearly need to be found and the Alliance is confident that matters are moving in the right direction.

But there must, absolutely must, be a separation for medical research. For today’s patients and the many millions that will follow.

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