Questions and answers on the Critical Medicines Act

Why is the Commission proposing a Critical Medicines Act?

Over the past decade, EU Member States have been confronted with severe medicine shortages on various occasions, and several categories of medicines have become increasingly prone to shortages. As witnessed during the COVID-19 pandemic, shortages can be particularly problematic in crisis situations, where demand increases sharply. Another challenge is that access also varies greatly between Member States for certain medicines. Lack of availability and shortages of medicines pose a substantial risk to public health and patient safety and undermine the functioning of healthcare systems.

Furthermore, the EU's strong and competitive pharmaceutical sector is essential to ensuring our wider economic security and citizens' jobs, employing around 800,000 people across the EU. At the same time, production of generic medicines has increasingly moved outside of Europe, and there is a reliance on certain suppliers and countries which produce key medicines and pharmaceutical ingredients.

The Critical Medicines Act is an industrial policy toolbox to protect patients and enhance manufacturing capabilities. It complements the proposed reform of the EU's pharmaceutical legislation and the enhanced role of the European Medicines Agency in managing shortages. The Act aims to reduce critical medicine shortages and create better security of supply throughout the EU. It provides measures to address supply chain vulnerabilities for critical medicines and to reduce Europe's dependency on single suppliers and third countries. It also proposes measures to address market failures, whereby certain EU countries do not have access to medicines of common interest.

The Critical Medicines Act is one of the actions set out in the Competitiveness Compass, since it is vital for EU competitiveness to ensure a reliable and diversified supply of medicines in this strategic area.

What are the causes of medicine shortages in the EU?

There are many, complex reasons why the EU has faced medicine shortages in recent years. The challenges arise along the pharmaceutical chain, from manufacturing problems to vulnerabilities in the supply of key ingredients. A survey showed that over 50% of reported shortages are caused by manufacturing issues, including shortages in active substances.

Global competition for resources and the concentration of production in a few countries also add to the problem. This was highlighted by the COVID-19 pandemic and geopolitical tensions, which exposed the EU's supply chain weaknesses and the risk of such dependencies being weaponised.

What does the Critical Medicines Act aim to achieve and how?

The Critical Medicines Act aims to address the issues above, by:

• strengthening Europe's manufacturing capacity;
• diversifying supply chains;
• reducing the EU's dependencies;
• incentivising resilience;
• leveraging demand.

This will help to ensure that Europe has a more stable supply of critical medicines. It will also help to increase access and availability of other medicines of common interest, where disparities between countries exist, such as certain medicines for rare diseases.

To achieve this, the Act sets out a series of industrial policy measures, such as the designation of Strategic Projects which aim to create, increase or modernise manufacturing capacity of critical medicines in the Union. Such Strategic Projects would benefit from certain incentives and facilitations. Access to EU funding will be facilitated for projects and actions that address vulnerabilities in the supply chain through STEP.

The Act also proposes measures related to public procurement as a way to incentivise secure supply chains and make markets more attractive for manufacturers, whilst giving Member States access to a stable supply of medicines. For critical medicines, public procurers will have to include a broader set of requirements in their procurement procedures, such as diversified sources of input material and monitoring of supply chains. In case of high dependency on a single or a limited number of countries, where justified, they will also have to use procurement requirements that favour critical medicine production in the EU. This will also be possible for other medicines of common interest in certain circumstances.

To ensure the safe supply of critical medicines from multiple sources, the EU will also seek to enhance existing bilateral cooperation in this area and build new strategic partnerships.

What would the Strategic Projects entail and how would this help tackle shortages?

The proposed Act defines criteria for certain industrial ventures which could be recognised as Strategic Projects, if they create, increase or modernise EU manufacturing capacity of critical medicines and their key ingredients. This can also include processes that ensure greater sustainability or increased efficiency, as well as the deployment of key technologies that enable manufacturing.

Strategic Projects will be given incentives to strengthen the EU supply chain, including fast-tracked permit procedures, streamlined environmental assessments and administrative and scientific support. Strategic Projects that address supply chain vulnerabilities can also have easier access to EU funding (including through a STEP Seal) and Member States will be able to prioritise financial support to these Strategic Projects, subject to certain conditions. The Commission has also published guidance on the application of State aid rules to support such projects.

Strategic Projects receiving financial support would have specific obligations to comply with, including the requirement to prioritise EU supply.

What does the Act propose on public procurement of critical medicines and other medicines of common interest?

The Critical Medicines Act proposes several different ways in which Member States' public procurement can be used to strengthen the resilience of supply chains:

First, the Commission will develop guidance on smart criteria that procurers in the Member States can use in their procurement procedures. Procurers will have to apply procurement requirements other than price in their public procurement procedures for critical medicines. These may include, for example, criteria related to diversified sources of input material, stockpiling and/or monitoring of supply chains.

For critical medicines with high dependency on a single or limited number of countries, public procurers, where justified, will have to apply procurement requirements that favour suppliers that manufacture a significant proportion of these critical medicinal products in the EU. Procurers will also be able to apply this requirement for other medicines of common interest, when justified. This would help to reduce dependencies and diversify supply.

Second, the Act outlines how Member States can request Commission support in the use of different collaborative procurement tools among themselves, such as joint procurement. This can create economies of scale and reduce access and availability disparities.

How would the Collaborative Procurement work?

The proposed Act provides a framework for Member States to request Commission support in using different collaborative procurement tools for critical medicines and other medicines of common interest, under certain conditions. There are several options to carry out this work:

1. The Commission supports cross-border procurement between Member States;
2. The Commission procures certain medicines on behalf of or in the name of Member States;
3. The Commission and Member States voluntarily engage in Joint Procurement.

Such procurement would always be voluntary and in respect of the principles of subsidiarity and proportionality.

Does the Act cover all medicines?

The Act is focussed primarily on critical medicines listed in the Union List (see below). These cover a wide range of medicines, from antibiotics and anti-thrombotics to cancer treatments and cardiovascular medicines.

Critical medicines are those with limited or no alternatives and for which a shortage of supply would result in serious harm to patients. They are medicines for which security of supply in the EU must be always ensured, for continuity of care, quality healthcare and the protection of public health protection across Europe. Certain provisions of the Act apply only to critical medicines that have specific vulnerabilities in their supply chain.

The Critical Medicines Act also covers certain other medicines of common interest that encounter market failures. These include, for example, medicines for rare diseases.

How does the Critical Medicines Act interact with the EU Pharmaceutical reform proposals currently being negotiated?

The reform of the EU's pharmaceutical legislation, proposed in 2023, seeks to provide all patients with more timely and equitable access to safe, effective and affordable medicines. It includes important regulatory measures to avert medicine shortages and to strengthen the security of supply critical medicines. These include stronger obligations on companies to ensure continuous supply of medicines, including by notifying shortages and withdrawals in advance and putting into place shortage prevention plans.

Coordination at EU level has also been strengthened, with the EMA and groups of national representatives offering prevention and mitigation measures, on-going monitoring and recommendations on ways to resolve or to mitigate critical shortages.

The Pharmaceutical reform also provides the legal basis for a Union List of Critical Medicines (see below) which will be regularly updated and analysed to identify vulnerabilities in the supply chain.

The proposed Critical Medicine Act complements the measures already put forward. It presents industrial policy solutions that can work hand-in-hand with the regulatory measures in the proposed pharma reform, to address vulnerabilities in the supply chain of critical medicines and mitigate the risk of shortages. As such, the Critical Medicines Act is part of our work to complete the European Health Union and is fully in line with goals of the Pharmaceutical Strategy for Europe.

What is the Union List of Critical Medicines and how is it integrated in the Act?

The Union list of Critical Medicines was created to help identify medicines for which continuity of supply is a priority, as they are critical to the proper functioning of EU healthcare systems. The first list was published in December 2023 and was updated in 2024 and currently has over 270 active substances, covering treatments for illnesses such as infections, cardiovascular diseases, mental health conditions and cancer. It was developed with the European Medicines Agency and all EU Member States, who assessed thousands of medicines using a strict assessment methodology. The Critical Medicines list is also used to support the Commission's analysis of vulnerabilities in the supply chains of the listed medicines. The Critical Medicines Act builds on the Union list of Critical Medicines that will be formalised under the EU Pharmaceutical Reform.

What role did the Critical Medicines Alliance have in the preparation of the Act?

The Critical Medicines Alliance was created in April 2024, to bring to together Member State, industry, trade, patient, medical and public sector representatives to look at how to strengthen the critical medicines supply chain. Over 300 stakeholder organisations took part in the process which resulted in a series of recommendations published on 28 February 2025.

Among the Alliance's recommendations were incentives to boost production capacity in Europe through a mix of EU and public funding and State aid; the use of criteria other than price in public procurement; a harmonised framework for contingency stocks; and measures to promote a level playing field between EU and third country producers of medicines. The Alliance also recommended increased outreach to third countries to address vulnerabilities in the medicines supply chain.

These recommendations were considered in the preparations of the Critical Medicines Act, together with other consultations activities such as the Structured Dialogue, the work of the Medicines Shortages Steering Group (MSSG) and Medicines Shortages Single Point of Contact Working Party and the Call for Evidence.