Entering a new era: The reform of EU-pharmaceutical legislation and its impact on pharmaceutical supply chains!

Pharmaceutical supply chains are the backbone of healthcare in Europe. In response to changing needs and challenges, the European Union launched a landmark reform of EU medicines law on April 26, 2023. This reform marks a significant turning point and represents a critical step in building a more sustainable and resilient healthcare infrastructure in Europe. In this article, you will gain detailed insights into the key objectives and cornerstones of this reform with regard to pharmaceutical supply chains in Europe and how it will significantly impact them.

As has become apparent in recent months, pharmaceutical supply chains face numerous challenges despite their enormous importance. One of the biggest difficulties is the increasing complexity of these supply chains: with globalisation, the processes for production, testing, and distribution of pharmaceuticals have become more and more complex and interconnected, thus increasing their vulnerability to disruption. Added thereto are a variety of increasing costs connected to research and development, increasing competitive pressures, and ever-growing regulatory requirements. Often, once price structures are negotiated and set, there is little opportunity to adjust them to reflect the rising costs of manufacturing.

Another major challenge lies in drug shortages, which come to the fore especially in times of crisis. These shortages can occur due to a variety of factors, such as production problems, logistical difficulties, or geopolitical conflicts, and have a direct impact on supply security.

To address these challenges, the European Union launched a comprehensive and ambitious reform of its pharmaceutical legislation on April 26, 2023.

Towards more resilient pharmaceutical supply chains!

The reform of the EU pharmaceutical legislation aims in particular at the following main objectives to strengthen pharmaceutical supply chains:

• Continuous monitoring:Competent authorities at national level and the EMA will continuously monitor the situation of drug shortages, and marketing authorization holders will still have to report potential shortages at an early stage and develop plans to prevent shortages.
• Increased coordination by EMA:The EMA will play a central role in coordinating the monitoring and management of critical drug shortages at the EU level, together with the High Level Steering Group on Monitoring Potential Drug Shortages.
• Transparency in drug shortages:Ensure transparent handling of drug shortages with the introduction of comprehensive reporting at national and EU level. This transparency is already given at some regulatory nodes but shall be intensified.
• Establishment of an EU-wide list of critical medicines:The EU Commission will establish a list of critical medicines that play an important role in healthcare and assess potential weaknesses in their supply chains.
• Response to critical shortages:Drug license holders are encouraged to be proactive in responding to critical shortages and to address those shortages, taking into account recommendations. They are also expected to report the results of actions taken, which could include increasing production capacity, restructuring or adjusting distribution.

The EU pharmaceutical reform: setting the course for robust pharmaceutical supply chains!

This reform marks a significant step forward in EU health policy. The redesign of pharmaceutical supply chains strengthens their resilience to crises and ensures the health of EU citizens. At the same time, the EU is positioning itself as an attractive location for investment and research in the field of pharmaceuticals. In doing so, it consolidates its role as a global health player and provides its citizens with improved access to safe and cost-effective medicines.

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