Remissvar
Feedback till SLF/CPME ang HERA och nya antibiotika i Europa
Publicerad 24 november 2023
On 13 June 2023, the Council of the EU adopted the recommendation on stepping up EU actions to combat antimicrobial resistance in a One Health approach, which welcomed the Commission intention to “design of an EU multi-country pull incentive scheme to improve innovation, the development of new antimicrobials and access to existing and new antimicrobials where Member States can participate on a voluntary basis”.
As a first step, HERA is proposing an action to improve EU access to newly developed antimicrobials through EU multi-country revenue guarantee.
The study on bringing AMR MCM to the market commissioned by HERA provided options for incentivising innovation and access for antimicrobials. Among the schemes assessed (“lump-sum market entry reward”; “milestone payment”; “revenue guarantee”; and a combination of market entry reward and revenue guarantee) the revenue guarantee scheme appears as the most appropriate to improve EU access to recently approved antimicrobials. Further, the implementation of such schemes at EU level should be facilitated by the experience already gathered by some Member States: Sweden has notably two years of experience with implementing such mechanism and has successfully improved its access to the new antimicrobials, as shown by the evaluation report published in May 2023.
HERA has identified fifteen antibiotics which recently received EU authorisation (see below) but which are still not widely available in the EU. Some of these antibiotics could be targeted in upcoming HERA initiatives to improve EU access to antimicrobials.
HERA seeks feedback of the CSF on the antibiotics listed with regard to access and availability.
WG 2 Feedback coordination document antibiotic-tt-mf