Differences in Patient Access to Newly Approved Antibacterial Drugs in EU/EEA Countries

Abstract

The introduction of antibiotics in the beginning of the 20th century was one of the most important scientific breakthroughs in history. However, in recent decades, the growing threat of antimicrobial resistance (AMR) has shown the limitations of the current research and development programs for new antimicrobial drugs. In the last decade, 20 antibiotics, 7 β-lactam/β-lactamase inhibitor (BL/BLI) combinations and 4 non-traditional antibacterial drugs have been launched worldwide. Methods: This study aimed to assess the time to patient access for new antibacterial drugs in countries in the European Union and the European Economic Area (EU/EEA). Time differences in marketing authorization from the U.S. Food and Drug Agency (FDA) and the European Medicines Agency (EMA) were also described, as well as the availability of each drug in the countries in the EU/EEA according to the national competent authorities. Results: Substantial differences between countries were observed, with no or only one new drug available in some countries. Conclusions: Improving pricing and reimbursement timelines and fostering collaboration between national health authorities and market authorization holders can enhance timely and equitable patient access to new antibacterial treatments in Europe. Equitable and sustainable access to antibacterial drugs is a cornerstone in the battle against AMR.

Keywords

• antibiotics
• equitable access
• antibiotic resistance
• one health
• antibiotic access