The General Data Protection Reform (GDPR) entered into the trilogue phase in June with the aim of concluding discussions at the end of 2015 or soon thereafter. A new EPHA progress report describes the challenges of the GDPR experienced so far and confirms the crucial role of data for health research and science purposes.
In 2012, following the release of the European Commission’s proposal for a draft regulation (setting out a general EU framework for data protection) and a draft directive (on protecting personal data processed for the purposes of prevention, detection, investigation or prosecution of criminal offences and related judicial activities), EPHA released a Briefing on the GDPR which presented particular concerns from a public health perspective. It was complemented by a Position paper which called for a comprehensive and far-sighted regulation that would safeguard privacy, without restricting the use of data for health research purposes and clinical trials. This has been the basis for EPHA’s advocacy, which has mainly focused on the regulation.
EPHA’s new Progress Report has two objectives: to discuss the GDPR from a ‘health equity perspective’ and, related to the European Parliament’s amendments and the ongoing trilogue negotiations, to underline the importance of data sharing for (public) health research purposes to reinforce EPHA’s stance that health and scientific research should be exempt from obligations to seek specific consent from data subjects.
The report traces the GDPR over the last three years, taking into account the evolving public debate and developments at EU and national level. It explains why the amendments by the European Parliament under rapporteur Jan Philipp Albrecht (Greens, Germany) could be very damaging to health research.
The Parliament introduced more restrictive rules on the use of personal data in comparison to the Commission’s draft, and subsequently it also voted to remove the consent exemption for research in its first reading. This would mean that health researchers would need to re-contact all former study participants to obtain their consent for any piece of new research. Although the amendments include an exemption for the use of pseudonymised health data in research without consent, it would be very difficult to use in practice as it must be of ‘high public interest’ and proof has to be given that it cannot be carried out by using other methods.
Thankfully, the Council reintroduced important provisions that were contained in the Commission text, and the current version provides a much better basis for discussions, and crucially is more ‘health research friendly’ than the Parliament’s.
A General Approach on the draft Regulation was agreed at the Justice and Home Affairs Council meeting on 15 June 2015 under the Latvian Presidency in Riga and it remains to be seen how the trilogue negotiations between the Council, Parliament and Commission will pan out.
Although EPHA agrees that personal health data is extremely sensitive and requires a high level of protection, it is important to strike a fair balance between protecting privacy and ensuring that health research can be undertaken for the benefit of individuals and society at large. Moreover, vital safeguards to effectively protect personal health data are already in place, including ethics committees and pseudonymisation.
EPHA has been supporting the European Data in Health Research Alliance (EDHRA) , the website of which provides concrete examples of how the Parliament’s amendments would negatively impact research and on the lives of patients in practice.
Personal data plays an invaluable role in health research and is necessary for making epidemiological progress, combating rising health inequalities and protecting public health.
