Today, the Commission is adding to the EU Vaccines Strategy a strategy on COVID-19 therapeutics to support the development and availability of these, including for the treatment of ‘long COVID'. It supports research, development, manufacturing, procurement and deployment of medicines.

This Strategy is part of the European Health Union, in which all EU countries respond together to health crises and guarantee the availability of affordable medical supplies. It includes the following actions and targets:

Research, development and innovation

• Invest €90 million in population studies and clinical trials to establish links between risk factors and health outcomes
• Set up a ‘therapeutics innovation booster' by July 2021 to support the most promising therapeutics from preclinical research to market authorisation

Access to and swift approval of clinical trials

• Invest €5 million under the EU4Health programme to generate better safety data in clinical trials
• Provide EU countries with the financial support of €2 million under the EU4Health 2021 work programme for expedited and coordinated assessments to facilitate approval of clinical trials
• Explore how to support developers of therapeutics to build capacity to produce high-grade material for clinical trials

Scanning for candidate therapeutics

• Invest €5 million to map therapeutics and diagnostics to analyse development phases, production capacities and supply chains
• Establish a broader portfolio of 10 potential COVID-19 therapeutics and identify 5 of the most promising ones by June 2021

Supply chains and delivery of medicines

• Fund a €40 million preparatory action to support flexible manufacturing and access for COVID-19 therapeutics under the EU Fab project

Regulatory flexibility

• Authorise at least 3 new therapeutics by October and possibly 2 more by the end of 2021 and develop flexible regulatory approaches to speed up the assessment of promising and safe COVID-19 therapeutics
• Start 7 reviews of promising therapeutics by end-2021, subject to research and development outcomes

Joint procurement and financing

• Launch new contracts for the purchase of authorised therapeutics by the end of 2021
• Secure faster access to medicines with shorter administrative deadlines

International cooperation

• Reinforce engagement for the therapeutics pillar of the Access to COVID-19 Tools Accelerator
• Boost ‘OPEN' initiative for international collaboration.

 Image © European Commission, 2021