Filenews 6 May 2021
A strategy to support the development and availability of COVID-19 therapies, covering the full life cycle of medicines, from research, development and manufacturing to procurement and distribution, was adopted yesterday by the College of Commissioners and presented today by Commissioner Stella Kyriakidou, as part of the
strengthening of the Health Union. The strategy includes clear actions and objectives, including the adoption of three new therapeutic instruments for COVID-19 by October 2021 and possibly two more by the end of the year.
The Commission will draw up a portfolio of 10 possible COVID-19 therapies by June 2021 and identify the five most promising. It will organize bring together industrial players to ensure enough production capacity and fast construction, provide new mandates and joint procurement contracts.
As Commissioner Kyriakidou explained, "vaccinations save lives, but they cannot yet eliminate COVID-19. We need a strong boost in treatments to reduce the need for hospitalisation, speed up recovery times and reduce mortality. Patients in Europe and around the world should have access to world-class COVID-19 medicines. That is why we have set a very clear objective: by October, we will develop and adopt three new effective COVID-19 therapeutics that can be able to change the course of the disease. We will do so by investing in research and innovation, identifying new promising medicines, increasing capacity and supporting fair access."
Vice-President Margaritis Schinas stressed that "the situation in many intensive care units across the continent remains critical. We need to focus on both vaccines and therapeutics as two powerful and complementary ways to combat COVID-19. However, we currently only have one approved medicine to treat COVID-19. Acting on the best availability of medicines today, we ensure that patients receive the treatments they need while also preparing our future biomedical readiness A coordinated strategy for quick access to therapeutics will enhance our strategic autonomy and contribute to a strong Health Union."
In particular, it provides,
1 investment of €90 million in population studies and clinical trials in relation to COVID and the creation of a 'therapeutic innovation enhancing instrument' by July 2021 to support the most promising therapeutic substances, from preclinical research to marketing authorisation, by coordinating all research projects by boosting innovation and enhancing therapeutic development.
2- Access and rapid approval of clinical trials
• investment of EUR 5 million The EU4Health programme will create better, high-quality safety data in clinical trials to help achieve timely results.
• providing EU countries with financial support of €2 million. The EU4Health 2021 work programme for rapid and coordinated evaluations to facilitate the approval of clinical trials.
• research to support therapeutic developers to develop high-quality material production capacity for clinical trials.
3. Search for candidate therapeutic means:
• investment of €5 million for the mapping of therapeutic and diagnostic tests for analysis of development phases, capacity and supply chains, including possible bottlenecks.
• creating a broader portfolio of 10 possible COVID-19 therapies and five promising localizations by June 2021.
4. Supply chains and delivery of medicinal products:
• financing of a €40 million preparatory action to support flexible production and access for therapeutic instruments under the EU Fab programme, which in turn will become an important asset for the future of the European Authority for the Preparation and Response to Health Emergencies (HERA)
5. Regulatory flexibility:
• authorisation for at least three new therapeutic substances by October and possibly two more by the end of the year and flexible regulatory approaches to assess promising and safe therapeutic instruments.
• seven rolling evaluations for promising therapeutic substances by the end of 2021, subject to research and development results.
6. Joint procurement and financing:
• new contracts for the purchase of authorised treatments by the end of the year.
• faster access to medicines with shorter management deadlines.
7- International cooperation on the distribution of medicines to all:
• strengthening the commitment to the pillar of therapeutic application of Accelerator Tools - COVID-19.
• strengthening the OPEN initiative for international cooperation
Cna
