The availability of medicines has been a longstanding concern in the EU.  Throughout the last decade, the issue of medicines shortages has become systemic.  Shortages of medicines affect treatment regimens. They may also affect the health of EU citizens and, ultimately, the resilience of health systems in Member States. The root causes of shortages are multifactorial, with challenges identified along the entire pharmaceutical value chain, from quality and manufacturing problems to industry’s competitiveness. In particular, shortages of medicines can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components.

The COVID-19 pandemic has further highlighted the importance of ensuring continued supply of medicines, which is often taken for granted across Europe. This is especially true for the most critical medicines which are essential to ensure the continuity of care, the provision of quality healthcare and guarantee a high level of public health protection in Europe. The COVID-19 pandemic and the current consequential energy crisis have also brought to the fore questions regarding the

impact of the EU’s dependency on third countries for medicines, raw materials and ingredients used in pharmaceutical manufacturing. These developments have brought additional pressures which could result in further vulnerabilities in pharmaceutical supply chains.

The EU Commission has published a document on a “Structured Dialogue on the security of medicines supply“. The document is based on a mandate for a dialogue of different actors in the value chain of medicines from manufacturing, authorities, non-governmental organisations as well as from research. The aim was to gain a better understanding of the functioning of global pharmaceutical supply chains and to identify causes of potential vulnerabilities. The document now published presents the most important results of the analysis of supply security and possible measures.

The following weaknesses were identified in the dialogue:

• Increasing complexity and specialisation of pharmaceutical supply chains;
• Challenges related to the production process and technologies;
• Dependencies, including lack of geographic diversification;
• Exploiting the potential of data to improve predictability of supply and demand predictability;
• Regulatory complexity (especially different regulatory requirements in different regions).