EU: Proposal for a Critical Medicines Act

The EU Commission is consulting a Proposal for a Critical Medicines Act.

The European Union is grappling with a growing shortage of medicines, posing a serious risk to public health and patient care across its Member States. This issue is particularly concerning for critical medicines, where alternative treatments are limited or nonexistent, and supply shortages can result in significant harm to patients. Recent global events, such as the COVID-19 pandemic and Russia’s military aggression against Ukraine, have further exposed vulnerabilities in pharmaceutical supply chains. These shortages not only threaten public health but also disrupt healthcare systems and undermine trust in healthcare services across the EU.

In response, Member States, the European Parliament, and other stakeholders have urged the European Commission to address these challenges by strengthening supply chains for critical medicines. Several initiatives have already been implemented, including:

The Structured Dialogue on the security of medicine supply
The expanded mandate of the European Medicines Agency (EMA) to address shortages before and during public health emergencies
The proposed reform of EU pharmaceutical legislation
The adoption of a Communication on tackling medicine shortages in the EU
The publication of a Union List of Critical Medicines (‘the List’)
The establishment of the Critical Medicines Alliance

Medicine shortages arise from multiple factors along the pharmaceutical value chain, including quality issues, manufacturing problems, and industry competitiveness. A key issue is supply chain vulnerability, particularly when critical raw materials, intermediates, or active pharmaceutical ingredients (APIs) rely on a single supplier or a concentrated group of suppliers in one region.

To address this, the European Commission, EMA, and the Heads of Medicines Agencies published the first Union List of Critical Medicines in 2023. Updated in December 2024, the list now includes over 270 active substances covering treatments for infections, heart disease, mental health conditions, and cancer.

Most of these critical medicines are off-patent, meaning they are no longer protected by intellectual property rights. However, even for off-patent medicines, the EU market may depend on just one or two manufacturers. Intense competition often prioritizes the lowest price in procurement processes, leading companies to shift production or outsource key ingredient supplies outside the EU—particularly to Asia. This increasing dependence on a few suppliers makes the EU’s supply chains highly vulnerable to demand fluctuations, market exits, manufacturing issues, and regional disruptions.

Access to critical medicines also varies significantly between Member States due to factors such as market size and differing commercial strategies. As a result, patients across the EU do not always have equal access to essential medicines.

Objectives of the Proposed Initiative

The initiative will focus on critical medicines, where shortages pose a serious risk to patients, as well as certain other medicines of common interest where market forces alone do not guarantee sufficient availability. Its primary goal is to enhance supply security and ensure consistent access to these medicines across the EU. To achieve this, the initiative will propose measures to:

Encourage investment in diversified manufacturing for critical medicines, particularly to address supply chain vulnerabilities.
Reduce supply disruption risks by incentivizing resilient supply chains in public procurement.
Leverage joint demand from Member States through collaborative procurement of critical and other essential medicines.

These measures will complement broader pharmaceutical reforms under the EU Pharma Package. The initiative also aims to create a more favorable environment for establishing or expanding manufacturing facilities for critical medicines within the EU. Strategic projects may benefit from accelerated administrative processes, regulatory and scientific support, and access to financial aid, thereby strengthening supply chain resilience.

Additionally, the initiative will introduce procurement incentives beyond cost alone, encouraging factors such as supply security and diversity in supplier selection.

By implementing these measures, the EU seeks to build a more resilient pharmaceutical supply chain, ensuring the steady availability of critical medicines and reducing risks associated with supply disruptions.

You can take part in the public consultation at the Commission‘s website: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14486-Critical-Medicines-Act_en