Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory and Scientific Strategies to Combat Antimicrobial Resistance in the EU ***

Jessica Jeschke (Abschlußjahr: 2024)

Summary
Language: English
The discovery of the first antibiotic penicillin in 1929 by Alexander Fleming was shortly followed by the identification of penicillin-resistant bacteria. During the golden era of antibiotics from 1940 to 1970, numerous antibacterial substances were identified and the occurrence of further resistances was observed. The decline in the identification of new antibiotic substances from 1970 onwards and increasing emergence of AMR pose a growing threat to human and animal health and the environment. Since the bacterial processes of acquiring resistance are part of natural evolution, there is a constant need for new effective therapeutics for the treatment of bacterial infections. The number of antimicrobial compounds currently under development is considered not sufficient to compensate for the increased amount of antibiotics that will be needed in the future to successfully treat (multi)drug-resistant bacterial infections. Several new strategies to combat bacteria have been developed. These include the use of bacteriophages, bacteria- or bacterial toxin-specific antibodies and others. In order to address the issue of increasing AMR, the ‘European One Health Action Plan against Antimicrobial Resistance (AMR)’ has been implemented in 2017. AMR is a key component of the revision of the pharmaceutical legislation and the ‘Recommendation on stepping up EU actions to combat antimicrobial resistance in a One Health approach’. They aim to (1) strengthen national action plans against AMR; (2) reinforce surveillance and monitoring of AMR and antimicrobial consumption; (3) strengthen infection prevention and control; (4) strengthen antimicrobial stewardship and prudent use of antimicrobials; (5) recommend targets for antimicrobial consumption and antimicrobial resistance; (6) improve awareness, education and training; (7) foster research and development (R&D) and incentives for innovation and access to antimicrobials and other AMR medical countermeasures; (8) increase cooperation; (9) enhance global action. Fighting AMR must be considered on several levels. First, the reasons for increasing emergence of AMR are required to be tackled. Second, antibiotic R&D needs to be strengthened and must become more (financially) attractive in the future. At last, afford-able newly developed and also traditional antibiotics must reach the patient via secure supply chains. Ultimately, all these measures are required to be addressed in a One Health approach, on a national level, but also on international level since AMR is a cross-border issue and human and animal health and the environment are intertwined. The pharmaceutical strategy for Europe aims to address all these topics. This thesis analyses the current antibiotic (pre-) clinical R&D pipelines and evaluates the planned regulatory measures which shall combat AMR.
Pages: 64
Annexes: 2, Pages: 5