In this eighth alert in our weekly series on the EU Pharma Package, we continue our overview of initiatives with respect to security of supply and shortage prevention and mitigation. Our last alert looked at how the Pharma Package seeks to address these issues. However, the Pharma Package does not exist in isolation, and in this alert we will discuss the interplay between its measures and those contained in other important EU initiatives such as the proposed Critical Medicines Act (CMA), and the Medicinal Countermeasures Strategy and the EU Stockpiling Strategy.
The CMA is still in the early stages of the adoption process. The Commission’s proposal for a regulation is currently being discussed in the Parliament and the Council. The CMA will complement the regulatory obligations in the proposed Pharma Package by focusing predominantly on enhancing industry opportunities and tackling the root causes of medicine shortages. The general aim of the CMA is to strengthen the security of supply and the availability of “critical medicines” within the EU, thereby ensuring a high level of public health protection. In addition, it seeks to improve the availability and accessibility of other specific medicines, the “medicines of common interest”.
Article 1(2) of the CMA lists the following specific objectives:
The structure of the CMA follows these four specific objectives and has a dedicated chapter with proposed measures for each. The proposed measures apply to either critical medicines, medicines of common interest, or both. Medical devices, diagnostics and digital health solutions are currently excluded from the proposed scope of the CMA.
For the definition of critical medicines, the CMA builds on the proposed Pharma Package where a “critical medicine” is identified based on a common methodology taking into account (i) the seriousness of the targeted disease, and (ii) the availability of suitable alternative medicines. The CMA applies to critical medicines that are on the “Union list of critical medicinal products” – which, as explained in our seventh alert, already exists today and includes over 270 active substances.
“Medicines of common interest” on the other hand are products for which, in three or more Member States, the functioning of the market does not sufficiently ensure the availability and accessibility to patients in the quantities and presentations necessary to cover patients’ needs. This can include, for instance, certain medicines for rare diseases (orphan products) and novel antimicrobials.
The CMA establishes a “Critical Medicines Coordination Group”, composed of representatives of the Commission and Member States, to facilitate implementation of the CMA once it is adopted as a regulation.
This new coordination body is the latest addition to a growing list of bodies and authorities with competences in the field of shortages and security of supply – with some having regulating powers while others operate on a voluntary basis and/or have advisory powers only:
We will now consider the specific measures that have been proposed to reach the objectives of the CMA:
Any company or consortium of companies developing a project may ask a Member State to designate their project as a “strategic project”. A “strategic project” is a project located in the EU related to creating or increasing manufacturing capacity for critical medicines. The CMA lists four alternative criteria to qualify for strategic project designation.
A strategic project can benefit from fast-tracked permit-granting processes and streamlined environmental assessments, as well as administrative, regulatory and scientific, and financial support from the relevant Member State or the EU.
Due to budgetary constraints, Member States often have procurement rules in place that focus predominantly on reducing medicine acquisition costs and securing the lowest price. Public procurement of medicinal products accounts for almost half of all medicine purchases in the EU. The CMA recognizes that the public procurement of medicinal products is a powerful tool to improve security of supply and the availability and accessibility of other medicinal products. It introduces a requirement that contracting authorities also use Most Economically Advantageous Tender (MEAT) criteria in the tender award process for critical medicines, which allows for more prominence to be given to quality, beyond price considerations alone. The MEAT criteria could, for instance, include supply chain diversification and monitoring, environmental sustainability, social rights, and contract performance clauses on timely delivery and measures in case of non-timely delivery. The CMA allows for an exception to using the MEAT criteria where this can be justified by market analysis or considerations related to the financing of health services.
The industry associations support the introduction of a MEAT requirement instead of focusing too heavily on prices only. According to Medicines for Europe, the introduction of a MEAT requirement balances cost efficiency with supply security, ensuring greater resilience in the medicines market.
Furthermore, for critical medicines “for which a vulnerability in the supply chains has been confirmed”, and for medicines of common interest, contracting authorities shall (for critical medicines) / may (for medicines of common interest) favor suppliers that manufacture a significant proportion of the tendered medicinal products in the EU. Such favoring must however be applied in compliance with the EU’s international commitments, such as the World Trade Organization’s principles of national treatment and non-discrimination. The “vulnerability evaluation” for critical medicines again links back to the Pharma Package, as the Pharma Package tasks the MSSG with the evaluation of the supply chains of critical medicinal products to identify their vulnerabilities.
Collaborative procurement is an umbrella term for different types of procurement involving multiple actors with varying roles and responsibilities. The CMA aims to foster the use of collaborative procurement mechanisms and contains provisions for the following types of collaborative procurement:
The CMA builds upon the existing legal regime for these types of collaborative procurement:
The table below summarizes the provisions of the CMA with respect to the different types of collaborative procurement (Commission and Member State are abbreviated as EC and MS respectively).
The Commission will explore the conclusion of new international strategic partnerships between the EU and third countries or international organizations, to broaden the supply chain, diversify sources and reduce dependencies.
As we discussed in our last alert on shortages, the EU institutions appear to be highly sensitive tothe division of competence between the EU and the Member States as regards stockpiling, and do not seem willing to prohibit national security of supply measures, given the national competence of Member States with respect to public health within their own territory. However, the impact of such national measures on the pharmaceutical industry is not to be underestimated. By way of example, there is currently: a six-month stockpiling obligation for medicines under discount agreements (mostly retail generics) in Germany; a three-month stockpiling obligation for all reimbursed medicines in Poland; and a two and a half-month safety stock for all prescription medicines in the Netherlands. When you consider that Germany’s six-month stockpiling obligation, which affects a population of 80 million, represents the equivalent of nearly two years’ worth of supply in the Netherlands (population 18 million), the impact of such measures becomes clearer.
Both Medicines for Europe and the European Federation of Pharmaceutical Industries (EFPIA) have called for clarity, and for stronger responses from the EU to fragmented and disproportionate national stock requirements. National obligations for companies to hold additional stocks can pose significant risks with respect to environmental waste (large quantities of medicinal products expiring), economic sustainability (financial burden on inventory holding lies with the companies), supply flexibility (creation of shortages in some countries versus oversupply in others), and, ultimately, patient access.
Industry proposals include regulating disproportionate national measures or replacing national requirements with the European Solidarity Mechanism and emergency strategic reserves at European level co-funded by the EU and Member States, which should enable companies to efficiently reallocate stocks from one country to another to tackle a shortage. The European Solidarity Mechanism is currently a voluntary mechanism that allows Member States to support each other in the face of a critical medicine shortage and was developed in 2023 by the EMA’s MSSG. Cross-border stock reallocation is currently an issue as stockpiles can only be used in that national market and repackaging is often required, which is expensive and time-consuming.
The CMA itself does not contain anything on stockpiling at EU level and contains only a high-level “safeguard” related to Member States’ national stockpiling requirements and other unilateral national security of supply measures, such as stock monitoring and reporting, shortage notification rules, export bans and national restrictions on trade:
“Measures on security of supply applied in one Member State shall not result in any negative impact in other Member States. Member States shall, in particular, avoid such an impact when proposing and defining the scope and timing of any form of requirements for companies to hold contingency stocks. Member States shall ensure that any requirements they impose on companies in the supply chain to hold contingency stocks are proportionate and respect the principles of transparency and solidarity”.
A strategic reserve (“rescEU”) of European disaster response capabilities and stockpiles, including critical medical supplies, was established under the EU Civil Protection Mechanism.
In addition, on July 9, 2025, the Commission published the EU Stockpiling Strategy and the Medical Countermeasures Strategy, which are two of the key actions announced in the Preparedness Union Strategy that was adopted on March 26, 2025. The EU Stockpiling Strategy integrates all existing sectorial stockpiling efforts, including those in the medicines sector, and aims to strengthen access to critical resources across the EU and combine centralized EU-level reserves with Member State contributions. It is not the EU’s intention to stockpile large quantities of all the essential goods mentioned in the EU Stockpiling Strategy, but rather adopt an anticipative, collaborative and comprehensive approach, and use EU-level stockpiling only when it is the most efficient solution to ensure essential goods during crises. The EU Stockpiling Strategy emphasizes again that an EU-wide approach is needed to complement and support Member States’ efforts – as opposed to replacing national measures.
The Medical Countermeasures Strategy on the other hand focusses specifically on preparedness for the next health emergency (for example, a pandemic, antimicrobial resistance, and chemical, biological, radiological and nuclear threats, by ensuring access to and availability of medical countermeasures and reinforcing collective resilience. It aims to boost coordinated action within the EU and at global level through combined surveillance and intelligence systems and streamlined funding to accelerate the development, production, and access to lifesaving products, including vaccines, antibiotics, diagnostics, and protective equipment.
Curiously, the Preparedness Union Strategy states that the Medical Countermeasures Strategy, which contains a specific “EU Strategic Plan for the Stockpiling of Medical Countermeasures” to complement the wider EU Stockpiling Strategy, will be further complemented by measures regarding contingency stocks under the recently proposed CMA. However, as we mentioned above, the CMA itself currently only contains a “safeguard” provision for national stockpiling requirements.
Overall, both EFPIA and Medicines for Europe support the general aim of the CMA to strengthen the supply chain for medicinal products and introduce procurement reforms. However, they have raised similar points of concern, including:
Security of supply and shortage prevention and mitigation is clearly high on the EU agenda, as is evidenced by the plethora of recent initiatives and the number of new competent authorities and other bodies that have been set up in recent years, especially since the Covid-19 pandemic. To obtain a clear overview and be able to assess the impact on the industry, the Pharma Package, the CMA, the different procurement legislations in the event of crises, and the EU’s overarching “Strategies” all need to be considered together.
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