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

Table of Contents

1 Introduction

1.1 Problem description

1.2 Research question and objectives

1.3 Structure of the work

2 State of research and methodological approach

2.1 State of research

2.2 Research design

2.2.1 Selection of the data collection method and type of research

2.2.2 Data collection

2.2.3 Data evaluation

3 Medicines distribution in the EU

3.1 Medicines regulation in the EU

3.1.1 Pharmaceutical definitions

3.1.2 Regulatory authorities

3.2 Supply chain of medicines marketed in the EU

3.3 Authorization procedure of medicines marketed in the EU

3.4 Reporting and monitoring of medicines marketed in the EU

4 Causes of medicines shortages

4.1 Manufacturing issues

4.1.1 Capacity issues

4.1.2 Quality issues

4.1.3 Ingredients shortages

4.2 Economic issues

4.2.1 Change in demand

4.2.2 Cost reasons

4.2.3 Market access

4.2.4 Lack of coordination

4.3 Political issues

4.4 Business issues

4.5 Catastrophic issues

5 Emerging risks of medicines shortages

5.1 Risks for pharmaceutical manufacturers

5.2 Risks for wholesalers

5.3 Risks for pharmacies and hospitals

5.4 Risks for patients

6 Solution approaches

6.1 Moving production back to the EU

6.2 Risk-based Quality Management

6.3 Increasing supplier diversity

6.4 Enhanced coordination and cooperation

6.5 Strengthen the European pharmaceutical legislative framework

6.6 Other solution approaches

7 Conclusion

7.1 Target achievement

7.2 Prospects and recommendations for future research

Research Objectives and Key Topics

This thesis aims to conduct a critical analysis of the causes and risks associated with medicines supply shortages within the European Union. The primary objective is to investigate the root causes of these bottlenecks, assess the associated risks for different stakeholders, and identify potential solution approaches to ensure a stable supply of essential medicines in the future.

• The structure and functioning of the European medicines supply chain.
• Categorized causes of shortages (manufacturing, economic, political, business, and catastrophic).
• Risk evaluation for various stakeholders: manufacturers, wholesalers, hospitals, and patients.
• Strategic solution approaches, including supply chain relocation and improved legislative frameworks.
• The impact of unforeseen global phenomena, such as the COVID-19 pandemic, on supply security.

Excerpt from the Book

Chapter Summaries

1 Introduction: Provides an overview of the growing problem of medicines shortages in the EU, outlines the research questions, and describes the thesis structure.

2 State of research and methodological approach: Examines current literature on medical supply issues and justifies the use of a secondary research methodology based on document analysis.

3 Medicines distribution in the EU: Explains the regulatory environment, the roles of key authorities like the EMA, and the lifecycle of medicinal products within the EU.

4 Causes of medicines shortages: Systematically analyzes the diverse origins of supply bottlenecks, including manufacturing, economic, political, business, and catastrophic factors.

5 Emerging risks of medicines shortages: details the specific hazards and financial/operational impacts of shortages for manufacturers, wholesalers, healthcare providers, and patients.

6 Solution approaches: Proposes strategic interventions, such as increasing supplier diversity, strengthening legislative frameworks, and implementing risk-based quality management.

7 Conclusion: Summarizes the research findings, evaluates target achievement, and offers recommendations for future academic inquiry.

Keywords

Medicines shortages, European Union, supply chain, EMA, pharmaceutical industry, manufacturing capacity, regulatory framework, drug pricing, supply chain security, COVID-19, market access, quality management, risk assessment, healthcare policy, export bans.

Frequently Asked Questions

What is the primary focus of this thesis?

This thesis focuses on providing a critical analysis of the root causes, inherent risks, and potential remedies regarding the increasing problem of medicines supply shortages across the European Union.

What are the central themes covered in the work?

The work covers the complexities of the European pharmaceutical supply chain, the classification of supply-related bottlenecks, and the multi-dimensional risks these bottlenecks pose to both the economy and public health.

What is the primary research question?

The research is driven by three main goals: identifying the causal factors of shortages, evaluating the magnitude and associated risks for various actors in the supply chain, and proposing viable strategies to ensure future supply stability.

Which methodology is employed in this study?

The author utilizes secondary research, specifically conducting a systematic document analysis. This method involves examining existing policy papers, academic literature, and reports from regulatory bodies like the EMA and European Commission.

What topics are discussed within the main chapters?

The main chapters systematically dissect the supply chain, categorize the causes of shortages (manufacturing, economic, etc.), assess the risks unique to different stakeholder groups, and evaluate various solution approaches.

Which keywords best characterize this work?

Key concepts include medicines shortages, European Union, supply chain management, pharmaceutical regulatory frameworks, and risk mitigation strategies in the life sciences sector.

Why does the author advocate for moving production back to the EU?

The thesis highlights the high dependence on Asian production sites for active ingredients, which represents a critical risk factor. Bringing production back to Europe is discussed as a strategy to enhance supply stability, despite potential cost increases.

How has the COVID-19 pandemic influenced the scope of the problem?

The pandemic exposed the fragility of globalized supply chains and acted as an accelerator for existing issues. The thesis notes that it created new shortages while also increasing political and public awareness, leading to the creation of new coordination networks like the i-SPOC.