On 6 May 2021, the European Commission published its “EU Strategy on COVID-19 Therapeutics” (the “Strategy”). With the vaccination programme now under way, the EU is shifting focus towards the development, approval and procurement of COVID-19 therapeutic products. The Commission intends to build on the experience from the EU vaccines strategy. In particular, the aim is to have three new therapeutics available by October 2021 and possibly two further products by the end of the year.
The Strategy touches on a number of key areas for both biotechnology and pharmaceutical companies operating in the space:
- Research and development: The Commission plans to set up a COVID-19 ‘therapeutics innovation booster’ by July 2021 to develop a clear overview of the COVID-19 therapeutics projects under development. This platform will bring together relevant actors, including the European Medicines Agency (“EMA”), national authorities, and the private sector, to identify promising research projects and technologies, their stages of development and provide guidance on where to best focus investments, in order to accelerate innovation. The Commission intends to mobilise certain financial instruments (including Horizon Europe, InvestEU and EU4Health) to aid development.
- Clinical Trials: The Commission proposes that €5 million are earmarked under the EU4Health programme to support coordination in safety assessment and improve quality of safety data generated in clinical trials. The Commission also intends to offer €2 million to support national competent authorities in carrying out expedited and coordinated assessments of clinical trial authorisation applications for COVID-19 therapeutics.
- Horizon Scanning: The EMA has already established an Emergency Task Force to identify the development of promising COVID-19 therapeutics. The Commission seeks to establish a portfolio of ten potential treatments and identify the five most promising ones by June 2021. As part of the upcoming proposal for a European Health Emergency Preparedness and Response Authority (“HERA”), the Commission intends to provide for an interactive mapping platform across all Member States for upcoming therapeutics to assess their development, manufacturing capacities and supply chains. This is envisaged for Q2 of 2022.
- Supply chain: Building on the experience of the EU Task Force for Industrial Scale-up of COVID-19 vaccines, the Commission intends to facilitate cooperation between actors in the supply chain to ensure that available therapeutics are produced in sufficient quantity as soon as possible. It will organise “matchmaking” events (starting in Q3 2021) for all supply chain actors, so that they can find solutions for bottlenecks.
- Regulatory process: The Commission intends to maximize use of the “rolling review,” allowing the EMA to check data from ongoing studies as they become available, before a formal application for the (conditional) marketing authorisation is submitted. The EMA is currently conducting rolling reviews of three COVID-19 therapeutics building on monoclonal antibodies and seven rolling reviews for promising COVID-19 therapeutics are expected to start by the end of 2021. The Commission is working towards granting conditional marketing authorisation for three new COVID-19 therapeutics by October 2021. Building on national emergency use procedures, the Commission is considering a legislative proposal for an EU emergency-use authorisation of medicinal products. The timing for the publication of this proposal is currently unclear.
- Procurement: Since late October 2020, the Commission has signed joint procurement contracts (under the Joint Procurement Agreement for medical countermeasures (“JPA”)) for 19 medicines (analgesics, antibiotics, muscle relaxers, anaesthetics, resuscitation, including dexamethasone, etc.) The Commission is currently discussing three new joint procurements for COVID-19 therapeutics.
The Commission recognizes that the JPA has limitations and is considering new streamlined solutions. This will involve increasing speed and flexibility in the current legal framework. In this regard, participating Member States and other joint procurement agreement signatories would need to:
- “adhere to shorter administrative deadlines;
- use a distribution key where the resources being procured prove to be scarce;
- place a certain percentage of orders in the first few months of the contract; and
- refrain from engaging in parallel procurement processes for the same products or services.”
The Commission is also looking at using advance purchase agreements or the ‘innovation partnership’ procurement procedure to procure supplies. The innovation partnership is a relatively new type of public procurement procedure. It allows for an innovative solution to be developed during the performance of the contract.
In addition, the Commission is considering the emergency stockpiling of therapeutics under rescEU, as part of the Union Civil Protection Mechanism.
- International Perspective: The Commission intends to expand the engagement with international partners on the development and fair distribution of COVID-19 treatments. The Commission also intends to increase the EU’s support through the Civil Protection Mechanism.