Legal obstacles jeopardise research in personalised medicine - experiences from a Nordic collaboration within rheumatology.

Aims: Personalised medicine in chronic complex diseases such as rheumatoid arthritis (RA) is within reach but requires international multi-stakeholder collaboration. We exemplify how national implementations of the General Data Protection Regulation (GDPR) have introduced administrative delays and created disincentives for data sharing and collaborative research.
Methods: Our Danish/Swedish/Norwegian research collaboration (the 3-year NordForsk-funded "NORA" project) aims to develop a personalised medicine approach for the management of RA, built on the exploitation of unique existing data sources: longitudinal data from clinical rheumatology registries, research cohorts, nationwide health care registries, and biobank material from >20 sample collections. Data and results are shared and accessed remotely by collaborators at secure servers. New biomarker assays and patient-centric implementations of the results are to be explored, validated, and disseminated to patients and health care via the development of digital tools.
Results: Following the advice of legal experts at the involved academic or public institutions and private companies, GDPR compliance resulted in >20 legal documents to govern the collaboration (consortium-, joint controller-, research collaboration-, data sharing-, and a series of unique two-way data processing-, and material transfer agreements). Lack of agreed-upon templates, policies, procedures, and a shortage of legal resources have caused considerable delays. Thus, our research consortium has spent more time ensuring GDPR compliance than on actual research activities.
Conclusions: The current interpretation and implementation of the legal premises (rather than the GDPR per se) for research collaborations caused unnecessary barriers and delays. Our experiences call for Nordic trust-based code-of-conduct-like framework agreements, and for harmonisation of procedures and templates, lest the Nordic advantage in research be lost.
Competing Interests: Declaration of conflicting interestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Bente Glintborg: research grants (paid to institution) from Pfizer, Sandoz, AbbVie, BMS. Chairs the steering committee of the Danish Rheumatology Quality Registry (DANBIO, DRQ), which receives public funding from the hospital owners and funding from pharmaceutical companies.Hilde Berner Hammer: honoraria and/or research grants from AbbVie, Lilly, UCB, Pizer and Novartis.Saedis Saevarsdottir: part-time employee of deCODE genetics.Johan Rönnelid: advisory board member for Thermo Fisher Scientific and Werfen/Inova.Isabel Gehring: employee of Thermo Fisher Scientific.Merete Lund Hetland: all the following has been paid to institutions (i.e. no personal income): study grants or contracts with AbbVie, Biogen, BMS, Celltrion, Eli Lilly; Janssen Biologics B.V., MSD, Pfizer, Roche, Samsung Biopies, Sandoz, Novartis, UCB. Lectures or presentations: Pfizer, Medac, Sandoz. AdBoard: AbbVie. MLH co-chairs EuroSpA, which generates real-world evidence of treatment of psoriatic arthritis and axial spondylorthritis based on secondary data and is partly funded by Novartis and UCB.Tue Kragstrup: speaking fees from Pfizer, Bristol-Myers Squibb, Eli Lilly, Novartis, UCB, and AbbVie. Consultancy fees from Bristol-Myers Squibb, UCB, Gilead, and Eli Lilly. Research grants from Gilead. Co-founder and clinical developer in Aptol Pharma.Ellen-Margrethe Hauge: fees for speaking and/or consulting from Novartis, AbbVie, Sanofi, Sobi; research funding to Aarhus University Hospital from Novo Nordic Foundation, Danish Rheumatism Association, Danish Regions Medicine Grants, Roche, Novartis, AbbVie; travel expenses from Pfizer, Sobi, AbbVie. Has been principal investigator of studies by SynACT Pharma and involved as site principal investigator in trials by AbbVie, Novartis, Novo, Sanofi. None of the aforementioned undertakings relate to this manuscript.Johan Askling: Karolinska Institutet has entered into agreements with the following companies, with Johan Askling as principal investigator: Abbvie, BMS, Eli Lilly, Galapagos, Janssen, Pfizer, Roche, Samsung Bioepis and Sanofi.The remaining authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.