Causes and risks of medicines supply shortages in the European Union. Critical analysis

Inhaltsverzeichnis (Table of Contents)

• Introduction
• Problem description
• Research question and objectives
• Structure of the work
• State of research and methodological approach
• State of research
• Research design
• Selection of the data collection method and type of research
• Data collection
• Data evaluation
• Medicines distribution in the EU
• Medicines regulation in the EU
• Pharmaceutical definitions
• Regulatory authorities
• Supply chain of medicines marketed in the EU
• Authorization procedure of medicines marketed in the EU
• Reporting and monitoring of medicines marketed in the EU
• Causes of medicines shortages
• Manufacturing issues
• Capacity issues
• Quality issues
• Ingredients shortages
• Economic issues
• Change in demand
• Cost reasons
• Market access
• Lack of coordination
• Political issues
• Business issues
• Catastrophic issues
• Emerging risks of medicines shortages
• Risks for pharmaceutical manufacturers
• Risks for wholesalers
• Risks for pharmacies and hospitals
• Risks for patients
• Solution approaches
• Moving production back to the EU
• Risk-based Quality Management
• Increasing supplier diversity
• Enhanced coordination and cooperation
• Strengthen the European pharmaceutical legislative framework
• Other solution approaches
• Conclusion
• Target achievement
• Prospects and recommendations for future research

Zielsetzung und Themenschwerpunkte (Objectives and Key Themes)

This Bachelor Thesis examines the causes and risks of medicines supply shortages in the European Union. It aims to critically analyze the factors contributing to these shortages and identify potential solutions.

• Critical analysis of the causes and risks of medicine supply shortages in the EU.
• Exploring the impact of these shortages on patients, healthcare systems, and the pharmaceutical industry.
• Identifying and evaluating potential solutions to mitigate the risks of future shortages.
• Analyzing the role of regulation, supply chain management, and market dynamics in the context of medicine shortages.
• Evaluating the effectiveness of existing policies and proposing recommendations for improvement.

Zusammenfassung der Kapitel (Chapter Summaries)

• Introduction: This chapter provides a brief overview of the problem of medicines shortages in the EU, highlighting key facts and figures. It also introduces the research question, objectives, and structure of the thesis.
• State of research and methodological approach: This chapter discusses the existing literature on medicine shortages, outlining the research methodology employed in this thesis, including data collection methods, data evaluation, and research design.
• Medicines distribution in the EU: This chapter examines the regulatory framework for medicines in the EU, including pharmaceutical definitions, regulatory authorities, and the supply chain for medicines marketed in the EU. It also explores the authorization procedure and reporting mechanisms for medicines.
• Causes of medicines shortages: This chapter dives into the root causes of medicine shortages, analyzing factors such as manufacturing issues (capacity, quality, ingredients shortages), economic issues (demand, cost, market access, coordination), political issues, business issues, and catastrophic issues.
• Emerging risks of medicines shortages: This chapter explores the potential risks associated with medicine shortages for various stakeholders, including pharmaceutical manufacturers, wholesalers, pharmacies, hospitals, and patients.
• Solution approaches: This chapter presents a range of potential solutions to address the problem of medicine shortages, including strategies such as moving production back to the EU, implementing risk-based quality management, increasing supplier diversity, enhancing coordination and cooperation, strengthening the European pharmaceutical legislative framework, and exploring other approaches.

Schlüsselwörter (Keywords)

This work focuses on the challenges of medicine supply shortages in the European Union. It examines the complex interplay of factors, including manufacturing challenges, economic pressures, political decisions, and regulatory considerations. Key concepts explored include pharmaceutical regulations, supply chain management, risk assessment, and potential solutions to ensure secure and consistent access to essential medicines.