Lives are at stake in data protection talks

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

Data protection is currently being discussed in the ‘trilogue’ - the name for the discourse between the European Council, Commission and Parliament - in the run-up to a new Data Protection Regulation.

Now, one of the sticking points of this upcoming new ruling is that the European Parliament seems only to have focused on a blanket protection of personal data, without taking into account the myriad uses this vital information can have for research, especially in the world of medicine.

Parliament is undoubtedly acting with good intentions, but in this instance seems guilty of a knee-jerk reaction to fears over Google, Facebook and even the American government’s ability to process and use data with what the public sees as little concern for the individual.

Researchers do not operate in such a slap-happy fashion and it is a total misconception that it is impossible to keep personal data safe, while still allowing its use for medical research purposes.

Data has been used in research for decades and the reasons for its storage have nothing to do with what the Parliament seems to fear. To throw medical data into a catch-all protective blanket is to completely miss the distinctions and, therefore, the whole point.

It is a fact that, whenever they can, researchers will ask consent before using personal data. But it is also true that sometimes consent is hard to get in practical terms. Imagine a study into, say, diabetes on a Europe-wide scale, and trying to contact hold of every person involved. Asking for individual consent to use their tissue or results would cause serious logistical problems.

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So, should we throw away all this valuable data being gathered now and much that has stored down the years, thus ignoring the needs of 500 million potential patients across 28 member states?

Of course not.

If you are still not sure, here are a couple of examples of data use in the arena of health: Many studies using personal data have led to a better understanding of the damage that tobacco can do. Where did the now undisputed link between tobacco and lung cancer come from? Research.

Such studies have raised awareness in both the public and government and have helped save millions of lives.

Some of the above studies relied on reviewing patient records to determine whether individuals were eligible before they could be asked for consent. If the Parliament’s views end up in the final regulation, this could make future studies of this type very difficult or even impossible.

That is simply because the consent of data subjects would be needed for researchers to even identify suitable individuals to ask whether they wanted to participate in a study.

A second example is the knowledge that, at least in the UK, affluent women are more likely to get breast cancer than less well-off women, yet the latter are more likely to die from it.

A study showed that poorer survival rates of women from deprived areas are not caused by poorer access to healthcare or treatment, but are actually associated with problems unrelated to breast cancer, i.e. other diseases or co-morbidities.

This particular study used hospital and GP records to look at factors involved in cancer treatment such as treatment received and - no, really - even waiting times. To ensure that the outcome was unbiased - vital for meaningful research - the study received special approval to allow the use of identifiable data without consent.

The European Parliament’s amendments would make future studies of this kind impossible because the Data Protection Regulation would prohibit this. 

Let us remember that, in general, patients believe that it is important to share their data for research. It’s not difficult to see why - their own treatment certainly relies on past research and their children will benefit from research being carried out today.

It’s true there is a fear around the safety of personal data. Recent events across the Atlantic haven’t helped, nor has the recent ECJ ‘safe harbour’ ruling. yet robust and effective safeguards to protect personal data in research already exist

Researchers are obliged to keep data safe, and research using personal data always needs to be approved by ethics committee in the relevant country or countries. Such safeguards have kept data safe for many years, while not stopping the vital flow of research.

Limiting personal data use would have a stultifying effect on research, which will, in turn, have an impact on the health of today’s 500 million potential patients living in the EU, plus the generations to come.

The Brussels-based multi-stakeholder group, the European Alliance for Personalised Medicine (EAPM), is of the view that, in most cases, a one-time consent ruling would be a vital part of any regulation. This allows the individual to specify a broad range of uses for his or her data without researchers having to go back time-and-time again for permission for a specific study.

Broad consent is an important approach in health research because it allows participants to share their data for future research, in recognition of the fact that scientists cannot predict today what will be useful tomorrow.

This maximises the benefit of data resources. However, EAPM and others note that even this type of consent is not ideal in every circumstance. Sometimes it is not possible to seek consent at all.

The Alliance believes that it is crucial that the final regulation includes an exemption from consent for the use of health data in research. 

In the end, it is critical that the outcome of the trilogue debate produces a Data Protection Regulation that does not hamper research but finds a balance between the undeniable need to protect the individual data of patients and the wider public, yet does not ring-fence vital data to the point where much-needed medical research grinds to a halt.

That would make no sense interns of investment in European research nor for developing ground-breaking treatments, and arguably it would make even less sense morally.

The bottom line is that current and future lives are at stake.

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