The impact of the GDPR on health research will be the subject of a seminar taking place in Brussels on November 19, 2019. Entitled “Challenges for health research arising from the GDPR”, the meeting will examine impacts of GDPR on entities conducting health and related research, including universities, life sciences companies, medical schools, and academic medical centers, all of whose research activities are subject to the GDPR. Specifically, the seminar will address internation data transfers, data processing and national derogations. The meeting is designed to share and exchange information and knowledge at technical and practical level.

The General Data Protection Regulation (EU) 2016/679 (GDPR) is the primary EU law that protects the privacy of personal data. The GDPR applies to the processing of personal data of individuals located in the European Union (EU) and the European Economic Area (EEA), even if such processing takes place outside the EU or EEA, and it also applies to the processing of personal data that takes place within the EU and EEA, even if such processing pertains to persons located outside the EU and EEA. The GDPR also addresses the transfer of personal data outside the EU and EEA areas. The GDPR aims to give control to individuals over their personal data, to ensure the free flow of personal data between Member States and to simplify the regulatory environment for international business by unifying the regulation within the EU. Because research involving human health, drug safety and clinical trials requires the processing of personal data, the GDPR has posed particular challenges to the research sector both within the EU/EEA area and elsewhere.

The seminar will take place 18 months following the application of the regulation on 25th May 2018 and just over a year in advance of the launch of the Horizon Europe research programme on 1 January 2021. The meeting therefore will provide an opportunity to raise key issues with policy and decision-makers in advance of Horizon Europe and other EU and EU Member States/Associated Countries funded research programmes. The seminar will include participants from the EU, European Free Trade Associations Countries, the United States, South Africa, Canada, amongst others.

The meeting is being organized by ISC in cooperation with the National Institutes of Health, 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, Legal Pathways Netherlands and the Mission of Switzerland to the EU. It will take place at the Mission of Switzerland to the European Union, Place Luxembourg 1, Brussels on 19th November 2019.

08h30 Registration and coffee

09h30 Welcome: Maryline Maillard, S&T Counsellor, Mission of Switzerland to the EU

Introduction: Declan Kirrane, ISC

09h50 Keynote: Prof Kurt Zatloukal Medical University Graz

Keynote: Dr Robert Eiss, National Institutes of Health

10h30 Panel 1 Panel 1 - GDPR, Research and Appropriate Safeguards.

Moderator Jasper Bovenberg Attorney at law

• Albena Kuyumdzhieva, European Commission DG RTD
• Dyann Heward-Mills, CEO, HewardMills
• Nicolas Hamblene, Partner, Koen Law
• Audience Q&A

11h30 Coffee

11h45 Panel 2 Secondary research – real world evidence, big data research and biobanking

• Mark Barnes, Ropes & Grey
• Barry Desmond, Innovative Medicine Initiative IMI2
• Audience Q&A

12h30 Lunch

13h30 Panel 3 Transnational transfers of personal data for research

Moderator: Robert Eiss, NIH, Washington

• Alisa Verkeman, DG JUST, European Commission
• Marc Filliettaz, Swiss Institute of Bioinformatics (SIB) member of Elixir

Audience Q&A

14h30 Panel 4 Challenges for international academic and industry collaborations and Horizon Europe

Moderator: Triona McCormack, University College Dublin, Ireland

• Sebastien Fanti, Lawyer at Lexing Switzerland, Data protection and Transparency Officer of the Canton of Valais, Switzerland
• Lenny Shallcross World Dementia Council
• Audience Q&A

15h30 Conclusions

15h30 End of programme

Location: Mission of Switzerland to the European Union,

Place du Luxembourg 1, 1050 Ixelles

For further information, please contact:

Declan Kirrane

Declan.kirrane@iscintelligence.com

+32 494 34 60 40