Differences in Patient Access to Newly Approved Antibacterial Drugs in EU/EEA Countries
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...
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| Format: | Article |
| Language: | English |
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MDPI AG
2024-11-01
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| Series: | Antibiotics |
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| Online Access: | https://www.mdpi.com/2079-6382/13/11/1077 |
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| author | Anelia Zasheva Elina Batcheva Kremena Dimitrova Ivanova Antoniya Yanakieva |
| author_facet | Anelia Zasheva Elina Batcheva Kremena Dimitrova Ivanova Antoniya Yanakieva |
| author_sort | Anelia Zasheva |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-4dae9bf13a0d4f5ead797f9073d00e9f |
| institution | Kabale University |
| issn | 2079-6382 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Antibiotics |
| spelling | doaj-art-4dae9bf13a0d4f5ead797f9073d00e9f2024-11-26T17:46:38ZengMDPI AGAntibiotics2079-63822024-11-011311107710.3390/antibiotics13111077Differences in Patient Access to Newly Approved Antibacterial Drugs in EU/EEA CountriesAnelia Zasheva0Elina Batcheva1Kremena Dimitrova Ivanova2Antoniya Yanakieva3Department of Infectious Diseases, Military Medical Academy, 1606 Sofia, BulgariaDepartment of Pharmacology, Pharmacotherapy and Toxicology, Faculty of Pharmacy, Medical University—Sofia, 1000 Sofia, BulgariaDepartment of Health Technology Assessment, Faculty of Public Health, Medical University—Sofia, 1527 Sofia, BulgariaDepartment of Health Technology Assessment, Faculty of Public Health, Medical University—Sofia, 1527 Sofia, BulgariaThe 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.https://www.mdpi.com/2079-6382/13/11/1077antibioticsequitable accessantibiotic resistanceone healthantibiotic access |
| spellingShingle | Anelia Zasheva Elina Batcheva Kremena Dimitrova Ivanova Antoniya Yanakieva Differences in Patient Access to Newly Approved Antibacterial Drugs in EU/EEA Countries Antibiotics antibiotics equitable access antibiotic resistance one health antibiotic access |
| title | Differences in Patient Access to Newly Approved Antibacterial Drugs in EU/EEA Countries |
| title_full | Differences in Patient Access to Newly Approved Antibacterial Drugs in EU/EEA Countries |
| title_fullStr | Differences in Patient Access to Newly Approved Antibacterial Drugs in EU/EEA Countries |
| title_full_unstemmed | Differences in Patient Access to Newly Approved Antibacterial Drugs in EU/EEA Countries |
| title_short | Differences in Patient Access to Newly Approved Antibacterial Drugs in EU/EEA Countries |
| title_sort | differences in patient access to newly approved antibacterial drugs in eu eea countries |
| topic | antibiotics equitable access antibiotic resistance one health antibiotic access |
| url | https://www.mdpi.com/2079-6382/13/11/1077 |
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