Scientists in Europe have won a major battle over access to personal health data. A research coalition had worried that draft E.U. legislation would have sharply restricted scientific use of such data. This week, however, scientist-friendly amendments emerged from negotiations between the European Parliament, the European Council, and the European Commission.
“We are delighted with the outcome,” says Beth Thompson, a policy adviser at the Wellcome Trust in London who helped organize a months-long campaign to persuade politicians and officials to revise the legislation. The “compromise solution,” she says, “works for both the research community and the people.”
Three years ago, scientists had embraced the commission’s initial draft of the legislation, which strives to harmonize privacy rules for data collection, storage, and exchange across the continent. But last March, the European Parliament amended the legislation to mandate specific consent for the use of any data in medical research. The provision would force researchers to obtain permission from research subjects for any new direction of research, with rare exception; subjects would not be able to grant broad consent even if they wanted to do so. Thompson and others claimed that would have endangered large investments in disease registries, cohort studies, and biobanks.
In response, a broad coalition of European organizations issued open letters calling for the right to conduct research using personal health data without explicit consent, if ethical approval and strict confidentiality safeguards were guaranteed. In December 2014, the Wellcome Trust and six other organizations banded together to form the European Data in Health Research Alliance to protect medical research from restrictive regulation.
The efforts paid off: Under the revised legislation, scientists will have access to any data derived from patients and study subjects who give blanket consent for research. “Research is facilitated as far as possible in all kinds of aspects,” says Jan-Philipp Albrecht, a member of the European Parliament who helped craft the legislation. And data can be used for research in perpetuity, so long as consent is not withdrawn explicitly. The law is expected to be approved early next year.