Can GDPR work for health scientific research?
31.01.19
On October 22nd last year, EFPIA organized a workshop entitled “Can GDPR work for health scientific research”, together with our partners CIPL and FPF. Among the issues raised was the widespread uncertainty regarding the rules of the game under GDPR, a theme that was also highlighted in an EFPIA-commissioned report on legal barriers to the better use of health data released in December and available here. Clinical research is being made unnecessarily more complex and opportunities to re-use data for valid research projects are at risk of being lost. As the workshop report commented “the health research sector has so far survived GDPR rather than being strengthened by it” and this, at a time when the next wave of progress in healthcare will be driven by data.
Considering the importance, complexity and sensitivity of the issues, we need clarity, direction and dialogue. Take for example the question of consent. Guidance from some parts of the European Commission and from Ethical Committees of certain EU jurisdictions that data processing in scientific research should be based on legal grounds other than consent has understandably caused a debate.
What could this mean in practice? Of, course, informed consent will continue to be the basis for participation in clinical research, and disassociating such consent from the legal basis for processing data obtained through clinical trials, does not amount to renouncing accountability to research participants. Rather, the GDPR offers a new approach to accountability requiring anyone processing personal data to reflect on its basis, be purposeful, transparent, document and demonstrate compliance. However, when it comes to health research, we still see a lack of a supportive political context to enable collective pan-European solutions. The European Data Protection Board, the Commission and the Member States must all play their part in building those solutions.
EFPIA is ready to play its part and is supporting efforts to improve transparency about how data is used in research and promoting public discussion. We will be running a panel at the DIA meeting on February 6th to continue discussion about GDPR and clinical research as part of this effort.
More ambitious steps are also needed. EFPIA believes that the impact of GDPR on research should be reviewed and new initiatives may be needed. Last year’s European Health summit pointed to a possible way ahead by calling for the creation of a digital platform; other ways could include more reliable legal frameworks that enable the use of the patient data for health research in the interest of all patients.
