EU : Draft Critical Medicines Act published for comments

 

The EU Commission has published a proposal for the new Critical Medicines Act.  The ful name of the regulation is Regulation laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795.

The purpose of this Regulation is to enhance the security of supply and ensure the continuous availability of critical medicinal products within the European Union. In doing so, it aims to uphold a high standard of public health protection and contribute to the overall security of the Union. Additionally, the Regulation seeks to improve access to and availability of other medicinal products in cases where market mechanisms alone are insufficient to guarantee adequate supply and accessibility for patients. This is pursued with appropriate regard for maintaining the affordability of medicinal products.

In order to fulfil the objectives outlined above, the Regulation establishes a framework designed to:

(a) encourage investment in the manufacturing capacity of critical medicinal products, their active ingredients, and other essential components within the Union;

(b) reduce the risk of supply disruptions and enhance product availability by promoting supply chain diversification and resilience, particularly through incentives in the public procurement processes for critical medicinal products and other products deemed to be of common interest;

(c) utilize the combined demand of participating Member States through joint procurement procedures.

(d) support the diversification of supply chains also by facilitating the conclusion of strategic partnerships.

 

The reasons for this legislation are the following:

The European Union possesses a robust and competitive pharmaceutical industry, recognized as a global leader in medicine production and playing a significant role in the EU economy. The sector directly employs approximately 800,000 individuals and demonstrates particular strength in the research and development of innovative medicinal products.

Over recent decades, however, the pharmaceutical manufacturing landscape has undergone considerable change. Within the EU, production has increasingly focused on complex medicines that require advanced technological infrastructure, a highly skilled workforce, and sophisticated manufacturing processes. In contrast, the production of inputs for generic medicines has progressively shifted outside the EU. Meanwhile, nearly 70% of the medicines dispensed across Europe are generics.

The EU is now confronted with growing challenges in maintaining a stable and resilient supply of essential medicines that are vital to safeguarding public health. Recent global developments—including the COVID-19 pandemic and Russia’s aggression against Ukraine—have revealed weaknesses in the EU’s pharmaceutical supply chains. Shortages of critical medicines pose serious risks to patients and public health and place strain on the functioning of healthcare systems.

The underlying causes of these shortages are complex and multifaceted. Issues have been identified throughout the entire pharmaceutical value chain, including problems related to manufacturing quality, business decisions, intricate supply chains, and the broader competitiveness of the industry. In particular, disruptions often stem from a lack of supplier diversification and supply-side vulnerabilities affecting the availability of key ingredients and components.

When examining the reasons behind shortages of critical medicines—defined as those for which no suitable alternatives exist and whose unavailability may cause serious or potentially serious harm to patients—it is important to distinguish between off-patent or generic medicines and innovative or on-patent medicines. The market dynamics affecting generic medicines are often not applicable to innovative medicines.

EU healthcare systems have increasingly relied on generic medicines as a strategy to alleviate pressure on national healthcare budgets. Procurement practices for these medicines often prioritize the lowest cost, which, while economically beneficial, can contribute to the fragility of supply chains for these essential products.

 

The feedback to the proposal is open till the 19 June 2025.