On 19 November (Brussels, Belgium) ISC Intelligence hosted a meeting on the impact of the general data protection regulation (GDPR) on health research. The meeting was held at the Mission of Switzerland to the EU, and was co-organised by ISC and the US National Institutes of Health (NIH), Medical University, Graz, the Multi-Regional Clinical Trials Center of Harvard University and Brigham and Women’s Hospital, Ropes and Gray LLP, University College Dublin, and Legal Pathways Netherlands. Attendees of the meeting included representatives from each of these organisations, as well as stakeholders from academia, industry and the European Commission.
Kurt Zatloukal of Graz Medical University kicked off the meeting with a keynote presentation on the impact of the GDPR on EU health research programmes. Highlighting the importance of including patients as partners in research, he identified some key opportunities and challenges brought by the GDPR, which forms the basis of a trusted environment for accessing patient data whilst also creating barriers due to heterogeneous implementation across EU member states.
The next keynote was given by Robert Eiss from the NIH, who spoke on the topic of ‘Implications of the GDPR for EU-US Cooperation in Biomedical Science’. ‘Alzheimer’s disease prevention and therapy’ was identified as one of four transformative opportunities for EU-US collaboration. However, he highlighted some obstacles posed by the GDPR for transatlantic clinical research: varying standards of anonymisation between EEA member states, infeasible legal bases for data transfers, and issues with the consent requirements for secondary use of data. These issues have caused substantial delays in data transfers from EU partners of the NIH; for example, the International Genomics of Alzheimer’s project now has to run separate analyses on DNA sequencing data from US and EU sites, which limits the scope of analysis.
After the two keynote presentations, four panel sessions were held. The first focused on the appropriate GDPR safeguards for research, the second focused on the reuse of personal data for research, the third focused on transnational transfers of data for research and the final panel focused on challenges for international academic and industry collaborations and Horizon Europe. Speakers on these panels included representatives from the Innovative Medicines Initiative (IMI), DG Justice and Research & Innovation from the EU Commission, Privacy lawyers and Data Protection Officers, and academic project leaders. Common issues that were raised during the lively Q & A sessions included difficulties in identifying the appropriate legal basis for data collection and sharing, heterogeneous application of GDPR clauses due to member state derogations, and problems with international data transfers, for example in multi-site clinical trials. Following on from the meeting, the Science journal published an article which summarised some of the key issues that were discussed. ISC Intelligence will hold a follow-up seminar in May 2020.
Link to Science article: https://www.sciencemag.org/news/2019/11/european-data-law-impeding-studies-diabetes-and-alzheimer-s-researchers-warn
