The Combat Against Antimicrobial Resistance: An Overview of EU Recent Health Policies and Drug Regulations Promoting the Development of New Antimicrobials.

Abstract

Antimicrobial resistance, including antibiotic resistance, constitutes a major global public health threat. In Europe, antimicrobial resistance is recognized among the top three health threats, in line with the World Health Organization's prioritization. This narrative review examines recent key health and pharmaceutical policies and drug regulations in the European Union, aimed at combating antimicrobial resistance and promoting the development of novel antibiotics and alternative therapeutic approaches. It also highlights potential limitations within these initiatives. Between 2015 and 2024, the authors have identified only 14 newly authorized antibiotics by the European Medicines Agency (excluding withdrawn applications, generics, and new formulations of existing medicines). This underscores the stagnation in the development of antibiotics, potentially attributable to limited investments because of fears of low profitability, and a loss of technical expertise within the pharmaceutical industry. At the European Union level, the One Health Action Plan (2017) established a strategic framework to implement anti-antimicrobial resistance measures and stimulate research on antimicrobials. Furthermore, the forthcoming reform of the European Union general pharmaceutical legislation introduces new incentives to support development of antimicrobials. In parallel, the European Medicines Agency has reinforced its efforts to support development of antimicrobials through updated, or planned updates, of its regulatory guidelines and through its innovation-support regulatory tools (e.g., "Priority Medicine" scheme). Concurrently, interest in bacteriophage-based therapies as antibiotic alternatives is increasing, as reflected in recent updates to the European Pharmacopoeia and the work initiated on the European Medicines Agency guidelines for bacteriophage therapy. While all these initiatives represent meaningful progress, significant challenges remain, necessitating sustained collaborative efforts across stakeholders.