New European rules on Data Protection: a cause for concern

Hundreds of thousands of European citizens and patients are contributing data and tissue to health research. Their contributions are immensely valuable to progress in biomedicine. But proposals for new European rules on data protection run the risk of endangering such progress.

Protecting personal data is a hugely important, hugely controversial topic. European legislation on privacy and data protection still stems from a time at which Google and Facebook didn’t even exist, and US-led state surveillance of all global communications still seemed like a sci-fi scenario. Small wonder then, that proposals for a new so-called European General Data Protection Regulation (GDPR) were launched in 2012. Perhaps one of the most intensely lobbied pieces of European legislation, negotiations on the GDPR now seem to be drawing to a close. But the terms under which data can be used by medical researchers are still a major cause for concern. A recent Nature editorial discusses some of the main concerns. Last June, BBMRI-ERIC organized a Day of Action on ‘Data for Health and Science’ in which researchers voiced their concerns and proposed directions for resolution to European policymakers and members of the European Parliament. Together with other organizations including Federa, NFU and Inspire2Live, we  spoke out as well.

The main concern for medical research as we see it is the strong emphasis on detailed and explicit consent for specific purposes for processing. That may work for the likes of Google and Facebook, but not for research – not given the ways in which consent is ordinarily asked and provided in health care and medical research practice. Moreover, legislation and professional codes of conduct in research seem better suited to the task of distinguishing proper research from bad research and marketing. Some clauses suggested by Parliament stress that data in health research can be more freely when serving a ‘high’ public interest, but only if processed securely according to the ‘highest’ technical standards. These standards are as ambitious as they are ambiguous. Given that many forms of research won’t be able to meet these, they may grave frustrate proper research.

What’s next? The alternatives proposed by us and others from the ranks of academic medical research needn’t be seen as radical; hopefully they can still be taken on board. Discussions between the European Commission, European Parliament and Council of Ministers are still ongoing. In the meantime, we’ll be actively following and contributing to the discussion.

A recent Nature editorial discusses some of the main concerns for research. A joint statement from patient, academic and non-commercial research organisations throughout Europe can be found here. BBMRI-ERIC’s position paper can be found here.