Making better use of the potential of Big Data in the field of public health and innovation, in particular by setting up a new European data platform, is what the joint working group on mega-data, made up of representatives of the European Medicines Agency (EMA) and the heads of the national medicines agencies, proposes in a report published on Monday 20 January.
This document represents the second phase of an exercise launched in 2017 and which, in 2019, resulted in an overview of the situation highlighting opportunities for improving how drug regulation functions. This new step is therefore based on a selection of actions to be taken to develop the European approach to data use and evidence production.
A European platform
In its press release, the European Medicines Agency highlights a recommendation that it describes as particularly “ambitious”, namely the establishment of a European platform to access and analyse healthcare data. This platform would create a European network of databases of quality and content verified with the highest levels of data security, the report notes. It would be used to inform regulatory decision-making with solid evidence of healthcare practice. Called DARWIN, for “Data Analysis and Real World Interrogation Network”, the cost of such a body is estimated at between €10 and 20 million per year.
Other recommendations
The joint working party also suggests improving guidance and resources within the EU regulatory network for data quality and identification (selection of key metadata) and strengthening IT and analytical capacities. It also advises developing the skills needed to process and analyse mega-data within the network through training to strengthen the capacity of regulators to assess drug submissions using mega-data sources as part of the evidence of benefits and risks. It proposes to establish a learning initiative to track and review the results of these types of submissions.
The report also highlights the need to ensure that data are managed and analysed within a safe and ethical governance framework and in active dialogue with key EU stakeholders, including patients, health professionals, industry, health technology assessment (HTA) bodies, payers, device regulators and tech companies. All of these activities should be carried out in collaboration with international mega-data initiatives, it said.
It should be recalled that a few weeks ago, the European Parliament called on the Commission and the Member States to put in place a clear timetable on the developments envisaged for the establishment of a Europe of digital health, with mid-term evaluations and targets to be achieved (see EUROPE 12393/10). See the report at: http://bit.ly/36eLBWF (Original version in French by Sophie Petitjean)