On October 22, 2018, the European Federation of Pharmaceutical Industries in cooperation with the Future of Privacy Forum and the Center for Information Policy Leadership organized a workshop entitled “Can GDPR Work for Health Research.” In the first session, the workshop discussed the implications of the General Data Protection Regulation (“GDPR”) on clinical trials in the EU. The second session was devoted to further use of health data for scientific research. Among other things, this session discussed the relationship between the Clinical Trials Regulation (“CTR”) and the GDPR.
The CTR appears to subject further use of clinical trial data (i.e., any use outside the protocol) to consent. In a note available here, we point out that such a reading is overly restrictive. At the very least, the derogations in the GDPR for the use of health data for scientific research without consent should continue to apply.