PM+: One-time consent on data protection rules a 'necessity' for European health research

Written by John Crown on 13 March 2015 in Opinion Plus
Opinion Plus

The risk of potentially damaging consequences to Europe's health research if EU policymakers don't get Europe's data protection rules right is clear, argues John Crown.

From the day it was announced by the European commission way back in January 2012, the EU's plans to introduce a general data protection regulation have been shrouded in controversy and heated debate.

Unsurprisingly the proposal is having a difficult time winding its way through the EU's codecision process. However MEPs reached an agreement on the European parliament's position in 2013, and now the governments of the EU member states within the council are finalising their position, chapter by chapter.

Once the 28 member states agree on their approach, the so-called trialogue between the three EU institutions can begin and we will be one step closer to having far-reaching data protection rules.

The team at the European society for medical oncology (ESMO), as well as our partners, have been keenly monitoring developments from the perspective of public health research and following the adoption of the European parliament’s position on the data protection regulation, the cancer community became concerned about possible unintended, but potentially damaging, consequences to health research.

"The legislative resolution’s wording on articles relating to health research imposes, or can be interpreted as imposing, the requirement for researchers to ask for a patient’s specific consent every single time new research is carried out on existing data and/or tissues"

The legislative resolution’s wording on articles relating to health research imposes, or can be interpreted as imposing, the requirement for researchers to ask for a patient’s specific consent every single time new research is carried out on existing data and/or tissues.

Not only would this create additional administrative burdens on researchers in having to continuously ask for patients' 're-consent' on every single use of their data, but it could potentially endanger biological sample depositories (bio banking), population-based cancer registries, observational and - most importantly - pan-European health research seeking to find cures for patients.

So, with our partners, we have been working on raising awareness of a need to strike the right balance between protecting a patient’s right to control their data while maintaining the ease of access to this data for the purposes of public health research.

The concept of 'one-time consent' aims to provide the patient with the option of donating their data exclusively for health research, protected by strict ethical safeguards along with the option to withdraw their consent at any time.

That consent would be a fully informed, withdrawable, one-time process which would truly implement patients’ rights, rather than creating burdensome, possibly harmful consequences to the patient community.

The 1995 data protection directive led to different interpretations by member states of the items related to health research. Countries with flexible approaches interpreted the legislation liberally, allowing their health research sectors to progress rapidly, whereas others took a more stringent approach.

"We are therefore calling on those policymakers within the three EU institutions who will be negotiating in the trialogue to work together to include the concept of a one-time consent within the data protection regulation"

We are in an era where we cannot fully predict the advances of science, or what the next big breakthrough will be. This makes it very important to ensure that we get Europe's data protection rules right, especially when it comes to developing health research.

Our proposal provides the opportunity to harmonise health research standards, while protecting the patient’s data with the appropriate safeguards, in the EU by adding to the proposed regulation the concept of one-time-consent.

We are therefore calling on those policymakers within the three EU institutions who will be negotiating in the trilogue to work together to include the concept of a one-time consent within the data protection regulation.

 

About the author

Professor John Crown is an Irish independent senator and is writing in his capacity as a consultant oncologist on behalf of the European society for medical oncology (ESMO) as a member of the ESMO public policy committee

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