Data protection reform in the EU has taken another step forward following the publication of the General Approach reached recently by the Justice and Home Affairs Council. EFPIA welcomes the General Approach as balanced view on this important and complex subject.

As the EU embarks upon the path towards a data-driven, digital economy, it will be critical to ensure that data protection rules provide appropriate, adequate and constructive benefits that promote innovation in New healthcare products and services for the benefit of the EU patient population.

EFPIA considers that the General Approach has maintained the correct equilibrium, guaranteeing the perseveration of patient confidentiality, while ensuring that relevant data can still be gathered and disseminated with a view to advancing the fundamental scientific understanding of diseases and to improving the way in which we address medical conditions.

While we are keen to be part of the ongoing dialogue, EFPIA now calls on the European Commission, Parliament and Council to uphold this balance and adopt a harmonised approach towards the creation of effective data protection rules in Europe. Were this to be achieved, we believe that it would lead ultimately to improved outcomes for patients that would serve to boost the health of the general population and contribute to the sustainability of national health systems.

EFPIA Director General, Richard Bergström said: “We call on the parties involved in the trilogue to build on the General Approach, recognise the protections that are already in place in research, and provide for the possibility of further harmonisation where it will contribute to the EU’s wider policy objectives. EFPIA is committed to play its part in building the European data ecosystem for health research in partnership with other stakeholders.”

EFPIA also welcomes the positive statement from academic, patient and non-commercial research organisations, published today by the Wellcome Trust, which calls on the trilogue to consider exemptions for research, appropriate safeguards for data subjects and the need for flexibility and harmonisation.