This work deals with the issue of medicines shortages, also referred to as medicines bottlenecks, in the European Union. The roadmap for this work is to answer the three primary research questions: What are the main causes of the medicines shortages? What is the magnitude of the shortages and which risks are associated with the shortages for different groups of people along the supply chain of medicines? What are possible solutions to prevent shortages and instead ensure a stable and sufficient supply of medicines? The aim of this work is to better understand the root causes of the shortages, for example if those are organizational problems or infrastructural problems.
Moreover, it should be determined whether the problem of bottlenecks can be attributed to a few or a variety of causes. In the end, this work should provide solution approaches to tackle the causes and thus the occurrence of supply bottlenecks and to be able to efficiently forecast future shortages and enhance reactivity. It should be said that this thesis is firstly limited to human medicine, thus veterinary medicine does not fall within the scope. Secondly, it deals only with the causes of supply bottlenecks in the EU. Other countries such as the USA or Canada are also affected by supply bottlenecks but are not discussed here.
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
4.1.1 Capacity issues
Medicines are complex products that go through complicated development processes, approval procedures and manufacturing processes. The production of medicines can take several months or even years, during which time many errors or problems can occur. The more complex a product is, the more failure-prone can its production be.
In general, it can be said that every production has limited capacities. So, if the demand for a product increases, a bottleneck can occur if production does not catch up fast enough. In addition, it could happen that extraordinary incidents further limit the production. For example, there may be restrictions on production volume if there are major overhauls of equipment or production plants or if production capacities need to be expanded. Such measures have a temporary, negative impact on existing capacities. Moreover, an inadequate manufacturing approach like a non-existent or faulty time planning can lead to capacity problems and therefore to medicines shortages.
Another reason for capacity issues can be that a manufacturer is not able to expand his production when a competitor is for certain reasons not able to produce and deliver medicines.
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.
- Arbeit zitieren
- Linda Walter (Autor:in), 2020, Causes and risks of medicines supply shortages in the European Union. Critical analysis, München, GRIN Verlag, https://www.grin.com/document/1254824
