The proliferation of health data in our ever more digitalised world of health care creates opportunities for better research around – and delivery of – pharmaceutical innovation. However, these opportunities may be constrained around the legal barriers to the use of health data for these purposes, which are poorly understood, particularly in relation to the new General Data Protection Regulation (GDPR).
In this consulting report, sponsored by the European Federation of Pharmaceutical Industries and Associations (EFPIA), we summarise research evaluating the main legal barriers to the better use of health data for pharmaceutical innovation. Issues are evaluated according to barriers arising in utilising data to support six key activities across the lifecycle of a medicine: Epidemiology and pharmacoepidemiology: Identifying unmet need; Pharmacogenetics; Interventional studies; Non-interventional studies; Pharmacovigilance, and; Managed entry agreements.
We conclude that the GDPR does not create new legal barriers, and that most issues identified are in fact uncertainties rather than barriers per se. There is a strong case for industry to deal proactively with the uncertainties, sharing good practice and engendering trust by co-creating a code of conduct, and promoting a shared understanding of the value to society of pharmaceutical research.