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.
Table of Contents
Chapter 1. INTRODUCTION
1.1. Introduction
1.2. Background of the Research
1.3. Justification of the Research
1.4. Aims, Objectives and Scope of the Research
1.5. Outline of the Dissertation
1.6. Summary
Chapter 2. LITERATURE REVIEW
2.1. Introduction
2.2. Antimicrobial History
2.2.1. Microbes and Diseases
2.2.2. Facing Resistance
2.2.3. Global Action Plan Overview
1.1.1. The Three Pillars
1.1.2. Strategy and Timelines
1.1.3. Summary
1.2. The European Union AMR Strategy
1.2.1. Regulatory Institutions and Organizations
1.2.2. The Antimicrobial Regulation in the EU
1.2.3. The EU Enforcement Against AMR
1.2.4. Summary
1.3. The United States AMR Approach
1.3.1. The US Legal Structure
1.3.2. The U.S. National Plan Outline
1.3.3. The US Enforcement Against AMR
1.3.4. Summary
1.4. Comparison of Strategy
1.4.1. National Policy
1.4.2. Antibiotic Stewardship
1.4.3. Incentives, Budgeting and Costing
1.4.4. Outside Aspects
1.4.5. Summary
1.5. Conclusions
Chapter 2. METHODOLOGY
2.1. Introduction
2.2. Research Design
2.2.1. Choice of Research Methods
2.3. Population and Sampling
2.4. Data Collection
2.4.1. Questionnaires
2.4.2. Semi-structured Interviews
2.5. Data Analysis
2.6. Validity, Reliability and Bias
2.7. Ethics
2.8. Limitations
2.9. Summary
2.10. Conclusions
Chapter 3. PRESENTATION AND ANALYSIS OF DATA
3.1. Introduction
3.2. Questionnaire Results
3.2.1. Awareness and Communication
3.2.2. Antibiotic Usage
3.2.3. Changes in Legislation
3.2.4. Summary
3.3. Interview Results
3.3.1. Regulatory Approaches
3.3.2. National Plan Implications
3.3.3. Challenges and Practicality
3.3.4. Out of Scope Aspects
3.3.5. Summary
3.4. Respondent’s Recommendations
3.5. Conclusions
5.1. Introduction
5.2. Discussion
5.2.1. Findings in Relation to the Research Objectives
5.2.1.1. The EU and US Approaches on AMR (RO1)
5.2.1.2. Plan Implementation Impacts (RO2)
5.2.1.3. Challenges and Practicality (RO3)
5.2.1.4. Out of scope Aspects (RO4)
5.2.1.5. Summary of Findings
5.3. Key Conclusions
5.4. Limitations and Recommendations for Future Research
5.5. Research Reflexions
5.6. Final Conclusions
Objectives & Key Themes
The dissertation investigates the practicality of adopting national action plans against antimicrobial resistance (AMR) in the EU and the US. It explores how these regions translate global "One Health" strategies into regional legislation, the challenges faced during implementation, and the role of the pharmaceutical industry in these efforts.
- Comparison of EU and US regulatory strategies for AMR control.
- Evaluation of stakeholder engagement and the role of public awareness campaigns.
- Analysis of economic and regulatory challenges in incentivizing new antibiotic research.
- Practicality of integrating multi-sectoral "One Health" approaches into national policy.
Excerpt from the Book
2.2. Antimicrobial History
In 1942, the first human use of Penicillin was documented; by 1949, seven years later, an article regarding resistance to it was written (Osteomyelitis producing Staphylococcus aureus). 12, 13 Resistance continued to appear with the passing of the years (see the previous Figure 2). Today’s difference is the scale of the challenge we face: it has been globalized.
AMR is happening all over the world, and it is having severe consequences for humans, animals and the environment, also called “the three pillars” (GAP-AMR, 2015). 5 Understanding how resistance functions has been a necessity over the years, and the implications of it have demanded from public and private organizations to achieve, on top of other issues, urgency of action.
Summary of Chapters
Chapter 1. INTRODUCTION: Presents the background of antibiotic resistance, the justification for the research, and the core objectives concerning the practicality of national action plans.
Chapter 2. LITERATURE REVIEW: Analyzes the history of antimicrobials and the existing regulatory frameworks within the EU and the US in alignment with the WHO Global Action Plan.
Chapter 2. METHODOLOGY: Details the phenomenological approach and multi-method research design using qualitative and quantitative data collection via questionnaires and expert interviews.
Chapter 3. PRESENTATION AND ANALYSIS OF DATA: Examines the findings from the surveys and interviews, focusing on stakeholder perspectives regarding regulatory approaches, awareness, and implementation challenges.
DISCUSSION AND CONCLUSIONS: Synthesizes the research findings, offers critical reflections on the practical integration of national plans, and provides recommendations for policy and future study.
Keywords
Antimicrobial Resistance, AMR, Antibiotics, One Health, Global Action Plan, Regulatory Affairs, EU, US, Public Awareness, Drug Development, Stewardship, Legislation, Pharmaceutical Industry, Surveillance, Innovation.
Frequently Asked Questions
What is the core focus of this research?
The research examines the practicality of implementing national action plans against antimicrobial resistance (AMR) within the European Union and the United States, investigating how global guidelines translate into regional regulatory practice.
What are the primary themes discussed?
The work covers regulatory frameworks, the "One Health" approach, antibiotic stewardship programs, the economic incentives for new drug development, and the role of public and professional awareness.
What is the primary objective of this dissertation?
The aim is to investigate the practicality of including national action plans in the EU and US, identifying challenges and examining perspectives from the pharmaceutical industry regarding these goals.
Which methodology was chosen for this study?
The study utilizes a qualitative, phenomenological approach, incorporating primary data gathered through self-administered questionnaires sent to regulatory professionals and semi-structured interviews with subject matter experts.
What is the core subject of the main chapters?
The main chapters cover the historical context of AMR, a critical review of literature, the methodological framework, an analysis of empirical data collected from professionals, and a discussion comparing regional strategies.
Which keywords best characterize this work?
Key terms include Antimicrobial Resistance (AMR), One Health, regulatory strategy, antibiotic stewardship, EU and US policies, and pharmaceutical innovation.
How does the author view the pharmaceutical industry's involvement in AMR reduction?
The author identifies a paradox where industry is expected to reduce antibiotic use while simultaneously being incentivized to innovate, suggesting that clearer regulatory pathways and financial support are essential for engagement.
What role do "awareness campaigns" play according to this study?
Awareness campaigns are identified as a "corner stone" for adherence to national plans, helping to shift the perception of AMR from a purely scientific issue to a public health priority.
- Quote paper
- Margarita Christen (Author), 2017, The Antimicrobial Resistance Regulatory Strategy, Munich, GRIN Verlag, https://www.grin.com/document/385477
