OBJECTIVES: Addressing antimicrobial resistance (AMR) and facilitating the introduction of novel antimicrobials to the European market are growing priorities, as evidenced by the proposed pharmaceutical legislation. This study examines stakeholder recommendations based on public consultation feedback informing the legislation.

METHODS: The European Commission conducted a survey comprising 15 questions to gather stakeholders' perspectives on proposed legislative changes. Descriptive and thematic framework analysis was applied to open-ended responses. Subgroup analysis was conducted by stakeholder group to identify variations. Stakeholders' perspectives on the proposed legislation were compared to the final legislation to see if and how they were considered.

RESULTS: 478 participants completed the survey, representing a diverse range of stakeholders: 19% end-users, 7% researchers, 17% healthcare providers, 7.5% public bodies, 36% industry, and 13.5% other. Key recommendations emerged regarding (i) incentivizing research and development (R&D), (ii) pricing models, and (iii) responsible use. Stakeholders emphasized the importance of fostering public-private partnerships for early-stage R&D, providing regulatory flexibility and support for the development of novel antimicrobials and diagnostics, and implementing clear and stringent eligibility criteria. Although not suggested by stakeholders, the voucher system was included as an incentive in the legislation. Recommendations for pricing models included decoupling prices from sales volumes and exploring subscription-based models. Strategies to promote responsible use included incentivizing stringent usage, advocating for bans on over-the-counter antimicrobial sales, and promoting the systematic use of diagnostics.

CONCLUSIONS: Stakeholders highlighted the urgency of addressing AMR and the need for comprehensive strategies to stimulate research, develop innovative pricing mechanisms, and promote responsible antimicrobial use. Further adjustments are necessary to fully comply with stakeholder recommendations.