Europe Takes One Step Further into Big Data

It has been promised for a long time, but at last the European Union is moving decisively into comprehensive data-sharing on health. Today, the European Medicines Agency (EMA) initiated its Coordination Center for the Data Analysis and Real-World Interrogation Network—which, fortunately, will have the more user-friendly name of DARWIN EU.

The vision of DARWIN EU is to give EMA and national competent authorities in EU member states access to valid and trustworthy real-world evidence (RWE) on diseases, patient populations, and the use, safety, and effectiveness of medicines and vaccines right through their lifecycle. The coordination center now coming into operation has the task of developing and managing a network of real-world healthcare data sources across the EU and conducting scientific studies. Initially, only medicines regulators will be able to request specific studies, but the intention is that at a later stage, other stakeholders will also be able to seek this service.

The concept springs from the task force on big data that EMA set up in 2019 jointly with the Heads of Medicines Agencies in the EU. It is the top priority the task force identified as essential for the European medicines regulatory network to systemize its approach to data use and evidence generation, and to make best use of big data to support innovation and public health.

The overall goal is that a wide range of stakeholders will benefit, from patients and healthcare professionals to health technology assessment bodies and the pharmaceutical industry, if decision-making on the development, authorization, and surveillance of drugs is better supported. Darwin has also acquired a more topical tag as "an invaluable resource to prepare for and respond to future healthcare crises and pandemics."

Erasmus University Medical Center Rotterdam has been awarded a contract to set up the necessary infrastructure of the coordination center and establish the associated business services. Scientific studies to answer research questions that come up during the evaluation of medicines in the EU will be among the first outputs, and eventually a catalogue will be built up of real-world data (RWD) sources and metadata for use in medicine regulatory activities.

DARWIN will also have a role as “a pathfinder”– as EMA expresses it—for the upcoming European Health Data Space, due to be proposed by the EU in April, and billed as a comprehensive data collection and sharing facility for Europe. The first DARWIN EU pilot studies are scheduled for delivery in 2022. And for everyone who wants to get ahead of the game, a webinar to "introduce the establishment of DARWIN EU, highlight opportunities for collaboration, and answer questions" will be held by EMA on Feb. 24.