Answer given by Ms Kyriakides on behalf of the European Commission
6.12.2021
To date the following progress has been made in implementing the COVID-19 therapeutics strategy:
Scanning for candidate therapeutics: in June 2020, the Commission published a list of five promising therapeutic candidates[1], those that are either under rolling review or evaluation by the European Medicines Agency (EMA). Moreover, in October 2021 the Commission published a broader portfolio of ten most promising therapeutics candidates, following an objective and science-based selection by experts[2].
Ensuring a rapid and flexible regulatory process is the priority. In November 2021, the Commission granted two marketing authorisations for Regkirona (regdanvimab) and Ronapreve (casirivimab/imdevimab).
There are currently five pending assessments[3] of COVID-19 therapeutics by EMA:
— 2 products are under the rolling review[4]
— 3 applications for extension of indication for COVID-19 of already EU-wide authorised medicines[5], and
— 1 application for the marketing authorisation of a new product[6].
Joint procurement contracts: the Commission is helping to ensure that therapeutics are procured and delivered to Member States as soon as they are authorised. The Commission has already concluded four joint procurement[7] contracts for the purchase of COVID-19 therapeutics and could launch more by the end of 2021.
The Commission will put forward a proposal to amend the general EU legislation on medicinal products for human use by the end of 2022 in accordance with the objectives of the pharmaceutical strategy for Europe[8]. Currently the work is ongoing on the evaluation of the current legislation’s performance and the impact assessment of various policy options. An online public consultation on this initiative is open until 21 December 2021[9].
- [1] https://ec.europa.eu/commission/presscorner/detail/en/ip_21_3299
- [2] https://ec.europa.eu/commission/presscorner/detail/en/IP_21_5366
- [3] https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/treatments-covid-19/covid-19-treatments-under-evaluation
- [4] Evusheld and Molnupiravir
- [5] baricitinib, anakinra and tocilizumab
- [6] Sotrovimab.
- [7] https://ec.europa.eu/commission/presscorner/detail/en/ip_21_4827
- [8] https://ec.europa.eu/health/human-use/strategy_en
- [9] https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12963-Revision-of-the-EU-general-pharmaceuticals-legislation_en