EMA proposes 10 recommendations to unlock potential of big data

AI in pharma and healthcare

European regulators have proposed ten recommendations that aim to unlock the potential of big data for public health in the EU.

The recommendations come in a report from a joint task force of the European Medicines Agency and the Heads of Medicines Agencies.

Proposals from the task force are intended to improve how the European medicines regulatory network uses and generates big data, to support innovation and public health.

The most ambitious of the recommendations is the establishment of an EU platform to access and analyse healthcare data from across the European Union’s Data Analysis and Real World Interrogation Network (DARWIN).

This platform would create a European network of databases of verified quality and content with the highest levels of data security, and could be used to inform regulatory decisions with robust evidence from healthcare practice.

Other recommendations aim to enhance guidance and resources within the EU regulatory network for data quality and data discoverability and to build up computing and analytical capacity.

The joint task force advises to develop the skills to process and analyse big data within the network through training to enhance the capacity of regulators to assess applications for the authorisation of medicines that use big data sources as part of the evidence on benefits and risks.

It proposes to establish a learning initiative to track and review outcomes of these types of submissions.

There is also a need to ensure data are managed and analysed within a secure and ethical governance framework, backed with active dialogue between EU stakeholders such as patients, healthcare professionals, pharma, and health technology assessment bodies.

Established in 2017, the HMA-EMA Joint Big Data task force is composed of experienced officials and data experts from national EU regulators, the EMA, and the European Commission.

The first phase of its work was published in early 2019 and reviewed the landscape, identifying opportunities for improvements.

The practical suggestions made in the second phase of its work aim to inform strategic decision-making and planning by the HMA and EMA and to contribute to the upcoming EU Network Strategy to 2025.

The European Commission is considering the recommendations.