The New EU “Pharma Package”: Interplay With The Critical Medicines Act And Other Shortage Initiatives.

What You Need to Know 

• Key takeaway #1The proposed Critical Medicines Act (CMA) is designed to complement the Pharma Package by focusing on enhancing industry opportunities and addressing medicine shortages. It also aligns with other EU communications such as the Medicinal Countermeasures Strategy and the EU Stockpiling Strategy to ensure the availability of critical medicines and improve public health protection across the EU. 

• Key takeaway #2The CMA introduces several public procurement reforms by emphasizing the use of Most Economically Advantageous Tender (MEAT) criteria and providing more collaborative procurement opportunities. It also supports strategic projects to boost manufacturing capacities for critical medicines within the EU. 

• Key takeaway #3Fragmented national stockpiling measures remain an industry-wide concern and do not seem to be sufficiently addressed in the CMA. The industry advocates a unified EU approach to stockpiling and crisis preparedness, although it may be difficult to do away with national measures entirely, given the Member States’ powers with respect to public health in their own territory. 

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. 

Legislative status of the CMA 

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: 

• Strategic projects: facilitate investments in manufacturing capacities for critical medicines, their active substances and other key inputs in the EU; 

• Public procurement: lower the risk of supply disruptions and strengthen availability by incentivizing supply chain diversification and resilience in the public procurement procedures for critical medicines and other medicinal products of common interest; 

• Collaborative procurement: leverage the aggregated demand of participating Member States through collaborative procurement procedures; and 

• Strategic partnerships: support the diversification of supply chains also by facilitating the conclusion of strategic partnerships. 

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. 

Competent bodies and authorities 

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: 

• the European Commission; 

• national competent authorities for medicinal products; 

• the European Medicines Agency(EMA): In 2022, the EMA was given an extended mandate to manage the shortage of medicines through the adoption of Regulation (EU) 2022/123 on a reinforced role for the EMA in crisis preparedness and management for medicinal products and medical devices. The Regulation formalizes and strengthens some of the governance structures that the EMA had put in place during the Covid-19 pandemic:  

• the EMA’s Executive Steering Group on Shortages and Safety of Medicines (MSSG) – responsibilities include advising on the Union list of critical medicines and the list of critical shortages of Union concern; providing recommendations and coordinating activities that aim to prevent shortages or mitigate their effects; and advising the Commission on whether medicine shortages and other ongoing or imminent events should be recognized as “major events”; 

• the EMA’s Medicine Shortages Single Point of Contact (SPOC) Working Party – responsibilities include monitoring and reporting events that could affect the supply of medicines in the EU; and providing recommendations to the MSSG on all matters related to the monitoring and management of medicines shortages and other medicine availability issues. The SPOC Working Party intends to improve information sharing between Member States, the EMA and the Commission; 

• the EMA’s European Shortages Monitoring Platform (ESMP) – an interoperable IT platform to monitor and report on shortages of medicinal products. Both marketing authorization holders of centrally authorized products and national competent authorities must use the platform to submit data on the availability, supply, and demand of medicines in situations that require close monitoring; 

• the Health Emergency Preparedness and Response Authority (HERA) – HERA’s mission is to prevent, detect, and rapidly respond to health emergencies. HERA was established in the wake of the Covid-19 pandemic to anticipate threats and potential health crises, through intelligence-gathering and building the necessary response capacities. In the event of an emergency, HERA will oversee the development, production and distribution of medicines and other medical countermeasures – such as gloves and masks; and 

• the Critical Medicines Alliance – a voluntary public/private consultative mechanism bringing together relevant stakeholders from Member States, key industries, civil society, and the scientific community to identify challenges resulting from vulnerabilities and the most appropriate actions to address them. 

We will now consider the specific measures that have been proposed to reach the objectives of the CMA: 

Strategic projects 

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. 

Public procurement—award criteria 

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 

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: 

• Commission-facilitated Member State procurement (cross-border procurement); 

• Commission procurement on behalf of or in the name of Member States; and 

• Joint procurement. 

The CMA builds upon the existing legal regime for these types of collaborative procurement: 

• The legal basis for organizing a cross-border procurement is already included in article 39 of Directive 2014/24/EC (Public Procurement Directive): “contracting authorities from different Member States may act jointly in the award of public contracts”. Cross-border procurement can involve the use of a central purchasing body or take place between individual contracting authorities. 

• Article 168 of Regulation 2024/2509 (Financial Regulation) provides the legal basis for (i) procurement by the Commission on behalf of the Member States; and (ii) joint procurement between a Union institution or body, and one or more contracting authorities from Member States. Joint procurement requires an agreement between the participating entities setting out the practical modalities and the aspects of the decision-making process. 

• A number of legislative initiatives allow for joint procurement specifically in the context of crisis situations. Most of this legislation was adopted in the wake of the Covid-19 pandemic, when the need for flexible, swift joint procurement, and the gaps in the existing legislation, became clear:  

• Decision No 1313/2013/EU on a Union Civil Protection Mechanism (The EU Civil Protection Mechanism): allows for joint procurement in case of acute health emergencies; 

• Council Regulation (EU) 2016/369 on the provision of emergency support within the Union (the Emergency Support Instrument): allows for EU financial support and can be activated by a Council decision in case of ongoing or potential disaster. Although this Regulation did not allow the Commission to purchase supplies on behalf of the Member States at the time of the Covid-19 pandemic, it has since been amended to cover such circumstances; 

• Regulation (EU) 2021/522 establishing a Programme for the Union’s action in the field of health (EU4Health Programme) for the period 2021-2027, and repealing Regulation (EU) No 282/2014: can be activated by a decision in case of a serious cross-border threat to health or where a situation of public health emergency has been recognized and allows for joint procurement or procurement by the Commission on behalf of the Member States; 

• Regulation (EU) 2022/2371 on serious cross-border threats to health and repealing Decision No 1082/2013/EU: allows joint procurement with a view to the advance purchase of medical countermeasures for serious cross-border threats to health; and 

• Council Regulation (EU) 2022/2372 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level (the Emergency Framework): can be activated for six months maximum by a Council decision in case of a public health emergency and allows for joint procurement of medical countermeasures and raw materials. 

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). 

Strategic partnerships 

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. 

Stockpiling 

As we discussed in our last alert on shortages, the EU institutions appear to be highly sensitive to the 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. 

Conclusion 

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: 

• The CMA needs to go further and provide an effective response to fragmented national measures (stockpiling, export bans etc.) that disrupt the functionality of the single market. The current high-level “safeguard” provides insufficient protection for the industry. 

• Increased collaborative procurement is a positive development but it should remain a voluntary option and only be possible where there is clear added value. While it may accelerate patient access – for example for small volume medicines where there is a barrier to supplying smaller Member State markets due to volume constraints – it can also pose a huge burden on pharmaceutical companies in managing their supply. 
   
  The industry advocates clear criteria to identify those circumstances where collaborative procurement options would improve access beyond existing national pricing and reimbursement pathways – cf. the vague wording in the current CMA proposal where joint procurement and procurement on behalf of Member States is allowed “to the extent it will help improve the security of supply and availability of critical medicines, or the availability and accessibility of medicines of common interest”. 
   
  In addition, regulatory barriers to collaborative procurement such as national packaging and country-specific paper leaflets should be remedied. The adoption of multi-country packs and labelling harmonization across the EU could be useful here. 

• With respect to the broadly worded obligation for market actors to provide any information deemed necessary by the Commission or national authorities in the context of the CMA, duplication of information requests and submissions should be avoided by making appropriate use of the existing databases and IT platforms. For example, EFPIA notes that the information in the existing European Medicines Verification System (introduced in the context of the Falsified Medicines Directive) already provides timely intelligence on the number of packs for all prescription products supplied in various Member States. Leveraging this data would reduce the burden on manufacturers and streamline the vulnerability assessment exercise. 

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. 

For further information, please contact:

Kristof Roox, Partner, Crowell & Moring

kroox@crowell.com