The European Commission has referred to computer modelling and simulation in two of its publications on building a European Health Union.
The European Health Union package put forward by the European Commission to strengthen the EU’s health security framework, consists of 1 communication and 3 proposals for regulations :
This represents one of the most ambitious policy package ever proposed by the European Commission on health care issues and the role of the EMA and the ECDC. The Commission puts forward a growing range of preparedness tools to respond to future cross-border health threats across Europe.
Computer modelling and simulation appears twice in the documents. Firstly 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”
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 is a very important sign that both policy makers and regulators are increasingly aware of the benefits of in silico medicine technologies and their potential impact on society.