With the Covid-19 vaccination campaign just starting to gather momentum in the EU, the European Commission is already turning toward potential medicines: Health Commissioner Stella Kyriakides unveiled an action plan to provide the EU with anti-Covid-19 therapeutics on Thursday 6 May.
Because “vaccines will not eliminate the disease overnight”, the Commission notes, assuring that “therapeutics will still be needed for patients in hospitals and at home”, including for those suffering from the long-term effects of the virus.
And the Commission is counting on quick results, namely the marketing authorisation of three “new therapeutics” by October 2021 and possibly two more products by the end of the year.
The three treatments announced for October have already been undergoing a rolling review by the European Medicines Agency (EMA) for several months. These are: - REGN-COV2 - a combination of two antibodies - developed by the Swiss laboratory Roche and the American Regeneron; - regdanvimab (or CT-P59), a monoclonal antibody developed by the Korean company Celltrion; - a treatment candidate from the American company Eli Lilly combining the antibodies bamlanivimab and etesevimab.
A portfolio of solutions
In addition, the EMA has already issued opinions on a total of 57 Covid-19 therapeutics that are in development, the Commission said. It also recalls that seven continuous evaluations are due to start by the end of the year.
In the shorter term, by June, the institution expects to have a portfolio of ten potential therapeutics. It will identify five particularly promising ones and will set up a platform to “map” these promising therapeutics by mid-2022 at the latest, it explains.
This involves “analysing their development phases, production capacities, and supply chains, including possible bottlenecks”. An initiative it will finance with €5 million under the EU4Health programme.
For even more promising solutions, the Commission is also paying attention to the development phase of therapeutics, including continued financial support for research projects.
It also wants to facilitate access to large-scale clinical trials. These have to be authorised by Member States before they can start and, as national regulatory requirements differ, this can be particularly burdensome in the case of multinational trials. The Commission thus proposed €5 million to support cooperation on evaluation, again under EU4Health.
Vaccine strategy as a source of inspiration
The “portfolio” project, the use of continuous evaluations, and the accelerated procedures are reminiscent of the European strategy on vaccines adopted in June (see EUROPE 12508/4), the merits of which were praised by Commissioner Kyriakides. Other elements here also echo this earlier strategy.
In particular, the Commission assures that it will be able to grant conditional marketing authorisations, i.e. based on a less complete set of data, subject to a positive benefit-risk ratio - as it did for Remdesivir (see EUROPE 12551/29).
In this regard, it plans to launch a project in the third quarter of 2021 that would facilitate access by the EMA and national medical agencies to data to verify the safety and efficacy of therapeutic products - this project would be a pilot initiative for the implementation of a European Health Data Space, it says (see EUROPE 12712/27).
The new strategy also paves the way for joint procurement agreements to enable States to jointly purchase proven therapeutics on a voluntary basis.
The Commission reports that discussions are underway on three new joint procurement agreements for therapeutics currently awaiting marketing authorisation. These contracts could be concluded by the end of the year, Kyriakides told the press, noting “great interest” from Member States.
Mistakes not to be repeated
“More account should be taken of the particular requirements of procurement in emergency situations”, the Commission says in its paper.
It requires Member States and other contractors to commit to shorter administrative deadlines, to “use a distribution key when resources to be procured are scarce”, to place a certain percentage of orders in the first months of the contract, and to refrain from engaging in parallel procurement processes for the same products.
The institution is also making arrangements for the future production phase. “The experience with vaccines has shown us that once you get past the difficult stages of research and clinical trials, manufacturing capacity can potentially be a bottleneck. This is why we will support flexible European manufacturing and access to industrial facilities dedicated for our production”, commented the Commissioner.
The Commission thus promises €40 million in funding for a preparatory action to support such manufacturing: it will set up a production network under a project called EU Fab, which will benefit the production of both therapeutics and vaccines.
An asset for the future European Health Emergency Response and Preparedness Authority (HERA), the institution notes.
In addition, “pan-European matchmaking events” for the industrial production of therapeutics will be organised from the third quarter of 2021.
To consult the strategy: https://bit.ly/3nWLvxI (Original version in French by Agathe Cherki)