A threat to medical research projects in Europe has been averted. European Union politicians and officials agreed on 15 December to exempt research from some of the strict provisions in planned data-protection legislation.

“This is very positive for us – the biggest threats are over,” says Michaela Mayrhofer, senior project manager at the European Union's Biobanking and Biomolecular Research Infrastructure, which is building collections of billions of biological samples across Europe and is headquartered in Vienna, Austria.

The legislation, first proposed three years ago, is primarily intended to protect people from having their digital information exploited for commercial, or other, purposes. At first medical researchers viewed the proposed rules positively because they clarified procedures for sharing clinical and genomic data across European Union (EU) member states.

But earlier this year, the European Parliament added amendments that would have made it hard for scientists to efficiently use such data and link them to tissue samples.

Data unmasked

One amendment removed an exemption for researchers from a rule that all personal data remain anonymous in perpetuity. This would have created problems for scientists who need to unmask data in order to assess progression of diseases and long-term outcomes of treatments.

Another required researchers to obtain fresh consent from donors every time their data or tissues are used in a different study, something medical scientists say is unworkable.

But the compromise agreement between the parliament, the European Council and the European Commission now allows medical researchers to unmask data in special circumstances and to re-use an individual’s data and samples for multiple studies in different diseases, provided that person signs up to a general form of consent that covers all approved studies.

The agreement is expected to be rubber-stamped by the parliament’s civil liberties committee and by EU member states in the next few days.