European Commission Unveils EU Strategy for Covid-19 Therapeutics
On 6 May 2021 the European Commission (the Commission) presented its EU Strategy for Covid-19 therapeutics (the Therapeutics Strategy or TS) (see, attached Commission press release, memorandum and fact sheet). The TS seeks to complement the EU Vaccines Strategy which the Commission unreservedly qualifies as “successful” (see, Van Bael & Bellis Life Sciences News Alert of 18 June 2020). It contains seven sets of structural measures designed to deliver therapeutics for patients affected by Covid-19, including people suffering from the long-term effects of the Covid-19 infection which are known as “long Covid”. These cover the following areas:
- Research, development and innovation – Under the TS, the Commission will create a Covid-19 “therapeutics innovation booster” platform by July 2021 and support additional R&D.
- Clinical trials – The TS will improve clinical trials in several ways, including the cooperation in safety assessment; the generation of high-quality safety data; the pre-authorisation assessment of clinical trials; and the building of capacity for high-grade material used in clinical trials.
- Scanning for candidate therapeutics – The TS will expand the portfolio of promising therapeutics.
- Supply chains and delivery of medicines – The TS will offer funding for various manufacturing initiatives.
- Regulatory flexibility – The Commission will both maximise the effect of existing procedural possibilities, such as conditional marketing authorisations, and consider creating new avenues, including an EU emergency-use authorisation of medicinal products.
- Procurement and financing – The Commission will enhance the capabilities of existing instruments such as the Joint Procurement Agreement for medical countermeasures and advance purchase agreements. Significantly, it also plans to create a fast-track pathway for the joint procurement of medical countermeasures.
- International cooperation – The Commission will further engage with international partners and increase the assistance extended to affected third countries.
In addition to announcing these structural measures, the Commission also makes the bold promise to authorise three new therapeutics by October 2021 and possibly two more by the end of the year.