The Antimicrobial Resistance Regulatory Strategy

Margarita Christen

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Master's Thesis from the year 2017 in the subject Medicine - Pharmacology, Pharmacy, grade: 70, University of Hertfordshire, lang...

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Master's Thesis from the year 2017 in the subject Medicine - Pharmacology, Pharmacy, grade: 70, University of Hertfordshire, language: English, abstract: Some years after the first use of penicillin, resistant bacteria emerged. The phenomenon of resistance has continued to show up similarly for almost every marketed antibiotic product, endangering the safety of humans, animals and the environment. This major threat has been proven to have a worldwide impact. In response, national action plans must be implemented following "anti-resistance" guidance: WHO's Global Action Plan on Antimicrobial Resistance (GAP-AMR) in collaboration with FAO and OIE. These plans are to be adopted by 2017, aiding the protection of antibiotic medicines adhering to the approach of One Health. The aim of the current study was to review the process of such adoptions in the EU and US, understand its practicality, challenges and any out of scope issues.With the use of a phenomenological approach, this qualitative study found that thanks to the general population's increment in knowledge and awareness, collaboration and engagement grew stronger, especially among policy makers and pharmaceutical companies, but also healthcare leaders and providers, physicians and veterinarians, and patients. When trying to discover new antibiotic drugs, serendipity is not an option, therefore, companies must be incentivised to increase their antibiotic pipelines. During the analysis of the inclusion of the plans, a paradox appeared: due to the reduced use of antibiotics, it is difficult to motivate drug developers to increase research in new medicines and alternative forms of treatment. The research concluded, that legislation must be focused on supporting changes that will ease entry of antibiotics to the market (i.e. with a congruent regulatory pathway and/or with financial support of governments) to allow a practical inclusion of the national plans.