Vulnerabilities of the Global Supply Chains of Medicine

The availability of  medicines has been a longstanding concern in the EU. 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, Russia’s unprovoked and unjustified military aggression against Ukraine 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 security of supply was also identified as a central objective of the Pharmaceutical Strategy for Europe of November 2020. The Commission announced several actions aimed at improving the availability of medicines, in particular the Pharmaceutical Strategy initiated the Structured Dialogue on security of medicines supply.


This initiative is also closely related to the Commission’s New Industrial Strategy for Europe, as updated in 2021,and its objective to ensure secured supply chains in strategic areas, including health.


In parallel to the Structured Dialogue, based on lessons learnt from the COVID19 pandemic, the Commission created a new service, the Health Emergency Preparedness and Response Authority (HERA), with a mission to ensure availability of medical countermeasures i.e., including medicines, to prepare for and respond to health crises.

Furthermore, the mandate of the EMA has been extended to cover monitoring and reporting of shortages of medicines during public health emergencies and major events.


The purpose of this Staff Working Document is:

Section I: to present the main findings of the Structured Dialogue that should be considered in the analysis of supply security.

Section II: to map areas of focus at EU level, including both new and ongoing actions, for consideration and to inform further actions to improve the security of supply and the availability of critical medicines, APIs and raw materials ().

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