EU Commission recognizes benefits of in silico medicine in its European Health Union proposals

The set of proposals for a European Health Union published by the European Commission on 11 November, represents one of the most ambitious policy package on health care issues and the role of the EMA and the ECDC. By these proposals, the European Commission puts forward a growing range of preparedness tools to respond to future cross-border health threats across Europe.

The Avicenna Alliance is very pleased to note that the European Commission has referred to computer modelling and simulation in two of its publications on building a European Health Union!

First, the Commission Communication on building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats, mentions that:

“The rapidly evolving technological environment and digital solutions (AI, High Performance Computing, computational models and simulation system) provides an opportunity to update surveillance systems, integrating data from new and different sources, and to create sensitive systems that detect early signals”

Computer modelling and simulation is presented as a separate digital solution next to AI and High Performance Computing. This shows that the Alliance’s feedback to the numerous Commission's public consultations on health-related topics is bearing fruit

Secondly, the Commission’s Regulation Proposal to extend the mandate of the EMA specifically references the need for the EMA to, where appropriate, make use of computational models and simulations for clinical trials:

“In order to facilitate the work and the exchange of information under this Regulation, provision should be made for the establishment and management of IT infrastructures and synergies with other existing IT systems or systems under development, including the EUDAMED IT platform for medical devices. That work should also be facilitated by, where appropriate, emerging digital technologies such as computational models and simulations for clinical trials, as well as data… ”

This inclusion seems to be the result of the Alliance’s established position as an EMA Stakeholder. Bearing in mind the Alliance’s great network and expertise, we now witness the computer modelling and simulation for clinical trials being fostered within the EMA.

The proposals of the Commission still need to be discussed and agreed upon by the co-legislators. However, as demonstrated by the dates set therein and in light of the rapid action needed during this pandemic, the Commission expects the legislative process to be concluded relatively quickly. It is expected that upcoming EU policy files in the area of health will be considerably influenced by the framework of the European Health Union, for instance in terms of more coordination and cooperation across EU Member States.