Catching Up with Data Protection

The European Union's struggle to bring its data protection rules into the 21st century continues—haltingly—as the EU itself enters its new era, with a new European Parliament, a new President-designate of the European Commission, and a new European Commission due to take office in November. This has left the pharmaceutical sector, already out of breath from its struggles to catch up with data disclosure, in a new race—to avoid becoming a victim of excessive data protection.

The latest entry in this race is a working group that the European Forum on Good Clinical Practice has set up to explore the issue from the perspective of research. It says the proposals in the current draft of the EU's new data protection rules would restrict access to clinical information and "pose a serious, immediate threat to research." It warns of "a real danger we will sleepwalk into a position where we undermine health research designed to provide health care benefit." Because progress in understanding the factors underpinning good health is in large measure based on the use of personal data, such as health records, medical progress will be seriously impeded—even "irreparably damaged"—if access is denied, it says.

So great is the level of concern that EFGCP has decided to devote its two-day annual conference in January to the subject. "We have to get the balance right between privacy and research," Hugh T Davies, the chair of the working group, told Applied Clinical Trials. "Society needs to be fully informed in deciding on this balance," he went on, and the group will, he said, aim to promote debate with a statement reflecting the current positions and the issues at stake. It is putting together a report on data protection arrangements in research across the EU through an EFGCP survey, and exploring possible recommendations to legislators.

The legislative timetable fixed by the most recent discussion among EU leaders, at the June summit, noted the importance of ensuring "the protection and promotion of fundamental rights, including data protection," and urged adoption of "a strong EU general data protection framework by 2015." The European Parliament adopted its version of a reformed data-protection regime last March, and the member states are still debating the issue in the Council. Ministers reached a political agreement on some of the aspects of the proposal in early June, but the discussions there are far from concluded. As the Greek Minister for Justice, Charalambos Athanasiou, said after that meeting, the agreement "constitutes a good basis for future work.”

The EFGCP group's concern focuses on the position adopted by the European Parliament. "While protection of privacy must be a central tenet of any legislation, some amendments will make vital research unworkable," says EFGCP. As Davies points out, the parliament position seeks to remove some of the flexibilities that could allow continued data access for health research purposes. "Health could be an inadvertent casualty, with too many limits on the secondary access to data that is so vital to epidemiology and public health research."

Davies is conscious of the risks of being out maneuvered, or simply too late, in this debate, in which there are so many other interests at stake, from questions of national security to the activities of commercial giants like Facebook or Google. "We're minnows in a sea of sharks," he admits. But he is determined to press ahead towards the best possible exploration of the issue in public health terms. His own background is as a pediatrician, but he is now the Research Ethics Advisor at the UK's National Research Ethics Service, which provides support and training to research ethics committees. The EFGCP working group he chairs is itself, he says, a broad church, containing representatives from research, industry, CROs and authorities from across Europe, and it reflects a range of views on the subject, so he is not expecting an immediate common position to be established. But even if legislation moves faster than his working group, "this will be a useful forum, whatever happens," he says.