Development, procurement and responsible management of new antimicrobials

The aim of this topic is to prepare for the establishment of a pull incentive for new antimicrobials where there is an unmet public health need and a market failure. In line with the Pharmaceutical Strategy for Europe that was published in November 2020[[https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52020DC0761&from=EN]] innovative approaches at EU level should be developed for supporting research, development and public procurement of antimicrobials to address the issue of antimicrobial resistance. These approaches could make use of European legislation, such as the possibility of an innovation partnership[[https://ec.europa.eu/growth/content/8699-innovation-partnerships-keep-public-services-date_en]] that would allow for the combination of development of new antimicrobials and procurement elements and should be tailored to public health needs.

To that end, a preparatory phase is necessary. Proposers are expected to create the conditions for the establishment of a future innovation partnership. They should take advantage of the latest developments such as experiences gained within Europe on the advance purchase agreements for COVID-19 vaccines. With the help of experts, potential procurers of new antimicrobials in the Member States have to set out the requirements and conditions for the final product(s) to be developed and purchased. This will needs to be guided by public health needs and should be based on priority pathogens such as those identified by WHO[[https://www.who.int/medicines/areas/rational_use/prioritization-of-pathogens/en/

]]. These requirements and conditions needed to guide development will have to be developed with input of scientific experts and in close collaboration with Commission services, and need to be agreed upon with a view of EU Member States’ and Associated States commitments to purchase the new antimicrobials. Proposers should also develop a broad communication strategy towards stakeholders and other potential procurers.

Proposals are expected to address all of the following:

• Emerging health threats, particularly those resulting from antimicrobial resistance (AMR), and identification of relevant public health needs in the development of new antibiotics.
• Design of a feasible option for a pull incentive that combines EU support for late stage development of antimicrobials with procurement by Member States and Associated Countries (implementation of the pull incentive will be beyond the scope of this CSA).
• Readiness and interest of potential developers/suppliers of antimicrobials
• Market failures and the challenges of availability and accessibility of therapeutics.
• Conditions for development and purchase of new antimicrobials.
• Requirements for financing.
• Conditions for prudent use of new antimicrobials.