The EC proposed a new strategy for COVID-19 therapeutics. It supports R&D and contribute towards the establishment of HERA and a European Health Data Space.
The European Commission (EC) wants to provide an additional boost to the fight against coronavirus and proposed a Strategy on COVID-19 therapeutics on 7 May. The new strategy complements the Vaccines Strategy from 2020 and shall support the research, development, manufacturing and deployment of COVID-19 therapeutics including therapeutics specifically targeted at ‘long COVID’. The strategy builds on ongoing work by the European Medicines Agency (EMA) and the EC and is one of several initiatives to strengthen the European Health Union.
A factsheet outlines the background and clear targets of the therapeutics strategy. Despite advancing vaccinations, people are still falling ill of COVID-19. Therapeutics can help reduce the number of acute and severe cases, but there is currently only one authorised therapeutic in the EU. The new strategy aims at having three to five medicines newly authorised in 2021, three new joint procurements, and seven new rolling reviews. To achieve these numbers, the strategy proposes to boost research, development, and innovation to support promising drug candidates. It will build on current initiatives and investments, and work in close cooperation with the mapping of therapeutics launched under the European Health Emergency, Preparedness and Response Authority (HERA) preparatory action. Additionally, it will also invest €90 million into population studies and clinical trials. This should facilitate authorisation at national level, encourage multi-country trials, help with clinical safety assessments, coordinate assessments, and support the production of high-grade material for trials. The EU4Health Programme will support measures in clinical trials. Also within the area of research and development (R&D), the strategy foresees support to scan for candidate therapeutics and map treatments in their development stage.
Beyond R&D, the therapeutics Strategy proposes a strengthening of supply chains and the delivery of medicines through a preparatory action to support flexible manufacturing and teaming up of different players. Regulatory flexibility shall be achieved with quicker access to safety and efficacy data, and international collaboration will promote a fair distribution. In the area of procurement and financing, the EC plans to explore the use of advance purchase agreements.
The EC wants to move swiftly with the therapeutics Strategy. Already by June 2021, a portfolio of ten potential COVID-19 therapeutics should be drawn up to identify the five most promising ones. Shortly after, matchmaking events for industrial actors shall ensure sufficient production capacity, and new authorisations should become a reality before the end of the year. The strategy’s actions will feed into broader initiatives. While the actions to boost innovation, matchmaking, and manufacturing support measures will contribute to the new HERA, for which a proposal is due towards the end of the year, a pilot project on access to health data will serve the development of the European Health Data Space, also on the EC’s agenda for the fourth quarter of 2021.