The joint procurement by the European Commission (“Commission”) and the Member States of COVID-19 vaccines and therapeutics presented a significant milestone in the EU’s management of the pandemic.  In the aftermath of the pandemic, there have been repeated calls for more joint procurement.  This blog explores the existing mechanisms for joint procurement and also considers the Commission’s proposal for a Critical Medicines Act (“CMA”) and what it would mean for public procurement.

At a high level, there are already various mechanisms for joint procurement of medicinal products and medical devices both with and without involvement of the Commission.  The CMA proposal does not fundamentally change that but rather supplements the existing regimes.

The key aspect to be aware of is that both the existing regime and the draft CMA merely establish a framework for joint procurement, including the relationship among Member States and the Commission (if involved).  This framework focusses on establishing when joint procurement is possible and the mechanism for getting a joint procurement set up.  However, the framework does not specify in what circumstances Member States and/or the Commission might choose to engage in joint procurement, the terms of the tender or any resulting contract.

1. Existing Framework

a. National Procurement

Directive 2012/24/EU on public procurement (the “Procurement Directive”), as implemented into the national laws of EU Member States, governs public contracts at the national level.  The Procurement Directive permits contracting authorities of different Member States to award contracts jointly (Article 39).  For example, Estonia, Latvia and Lithuania concluded the Baltic Partnership Agreement, which has since been used several times to procure vaccines jointly.

b. EU-Level Joint Procurement

The EU has several legal mechanisms for joint procurement of medicinal products, which apply in different circumstances.

i. Joint Procurement in Crisis Situations

These mechanisms require either a formal activation decision and/or the formal establishment of a public health emergency before they can be used.  These include joint procurement under:

• The Emergency Support Instrument Regulation (EU) 2016/369, which applies broadly to the procurement of supplies and services. 

• The Emergency Framework Regulation (EU) 2022/2072, which applies to the procurement of “medical countermeasures” and raw materials.  “Medical countermeasures” include medicinal products, medical devices but also other goods and services necessary for preparedness.  

• The EU4Health Programme Regulation (EU) 2021/522, which also applies broadly to supplies and services.

ii. Joint Procurement Outside of Crisis Situations

At the moment, there are two key areas for joint procurement, which focus on the anticipation of a potential crisis situation:

• Regulation (EU) 2022/2371 on serious cross-border threads to health (“CBTH Regulation”) provides for the advance purchase of “medical countermeasures” in anticipation of a serious cross-border threat to health.  The CBTH Regulation requires a Joint Procurement Agreement (initially concluded under the previous framework) between the Commission, the Member States and certain other parties, which sets out the practical arrangements for the procurement process.
• Participation in this joint procurement is open to EU and EFTA Member States, as well as EU candidate countries, Andorra, Monaco, San Marino and the Vatican City State. 
• The Health Emergency Preparedness and Response Authority (“HERA”) has relied on the CBTH Regulation for the procurement of certain vaccines.
• In the recently published Review of the implementation of the operations of HERA (“HERA Review”), the Commission highlighted some of the “lessons learnt” from their joint procurement activities so far include “the need to ensure that purchase agreements promote post-authorisation and comparative research” in order to contribute to the reliable supply of medical countermeasures.

• The EU Civil Protection Mechanism Decision No. 1313/2013/EU (rescEU) permits the joint procurement of certain goods for stockpiling purposes.  In the HERA Review, the Commission indicated that stockpiling remains a Member State competence and that stockpiles under rescEU should be “used as a last resort.”  That said, in the European Preparedness Union Strategy (“Preparedness Strategy”), the Commission indicated an intention to propose an EU-wide stockpiling strategy.

2. Commission Proposal for a Critical Medicines Act

On 11 March 2025, the Commission presented its proposal for the CMA to the European Parliament.  The proposal has yet to go through the legislative process, so the details may change.  The CMA tries to enhance security of supply and accessibility of certain medicines.  The proposal touches on a number of areas and procurement is only one aspect of it.  However, it forms a core part of the proposal and therefore warrants a closer look at how it fits with the existing framework.

Before looking at the detail, it is worth clarifying that the CMA proposes measures for two categories of medicines:

• “Critical medicinal products” – These are defined as products for which insufficient supply would “result in serious harm or risk of serious harm to patients.”  The EU pharma law package introduces the concept of a Union list of critical medicines.  The package is still undergoing the legislative process at the time of writing.  Nevertheless, in anticipation of the new rules, the European Medicines Agency (“EMA”) has published a Union list of critical medicines. The list includes “medicines for human use for which continuity of supply in the EU is a priority” and may give a sense of the types of products that might be consider critical medicines.

• “Medicinal products of common interest” – these are not critical medicines but 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 the needs of patients in those Member States” (emphasis added).  The CMA is silent on how this would be determined.

Not every measure applies to both categories, so the distinction is crucial.

a. National Procurement

 The CMA is lighter touch on the national procurement side but still noteworthy:

• Award criteria (Article 18 CMA):
  • For critical medicines, Member States should move away from price-only award criteria and apply procurement requirements that foster resilience of supply, such as stockholding obligations, number of diversified suppliers, monitoring of supply chains, transparency vis-à-vis the authority and contract performance clauses on timely delivery. 
  • For critical medicines with supply chain vulnerabilities and certain medicines of common interest, authorities may favour suppliers with significant manufacturing operations in the EU.  The Commission intends to issue guidelines to authorities on the implementation of these obligations (recital 29).

• National procurement programmes:
  • Member States must establish national programmes to support security of supply of critical medicines.  These programmes should “promote the consistent use of procurement requirements”, as well as “multi-winner approaches”.
  • Notably, the programme may also cover measures for pricing and reimbursement strategies, which would further security of supply of critical medicines not going through public procurement.  The CMA itself does not distinguish between the purchase of medicines in inpatient and outpatient settings.  However, the recitals indicate that the Commission recognizes that the national healthcare systems vary significantly, noting that procurement rules tend to apply to the purchase of medicines in the inpatient sector, whereas it might not be relevant for outpatient supplies (recitals 24 and 30).

b. EU-Level Joint Procurement

Section II of the CMA is headed “collaborative procurements.”  In essence, the section provides for three different formats of joint procurement.  The key differentiating factor is the relationship between the Commission and the Member States under each option.

• Commission facilitator (Article 21 CMA): As noted above, Article 39 of the Procurement Directive already permits Member States to engage in joint procurement.  The perception is that this option is not used widely because of the administrative burden involved (recital 33).  In order to address this concern, the CMA proposes that three or more Member States may request the Commission to act as a facilitator for medicines of common interest.  If accepted, the Commission will provide secretarial and logistical support, as well as information on applicable procurement rules but otherwise will not have a substantive role in the tender process. 

• Commission on behalf or in the name of the Member States (Article 22 CMA):  This route is only available in specific circumstances, depending on the type of product in issue:
• For critical medicines: if (i) a vulnerability evaluation by the European Medicines Agency’s (“EMA”) Executive Steering Group on Shortages and Safety of Medicinal Products (“MSSG”) has identified a vulnerability in the supply chain or (ii) the MSSG has recommended a common procurement initiative.
• For medicines of common interest: if (i) there is insufficient accessibility or availability in three or more Member States (as defined above), (ii) a joint clinical assessment report has been published under Regulation (EU) 2021/2282 (“HTA Regulation”) or the product has undergone a clinical assessment under the voluntary cooperation among Member States.
• In addition, the joint procurement must help to improve security of supply and availability of the product or the availability and accessibility of the product, as applicable.
• Further, nine or more Member States must submit a request to the Commission to procure on their behalf or in their name and the Commission must accept the request.  The Commission’s acceptance may be dependent on exclusivity or minimum binding quantities.

• Joint procurement of the Commission and the Member States (Article 23 CMA): This route is only available in specific circumstances.  The products in scope are the same as outlined for Article 22 CMA.
• In addition, the Commission may conduct the joint procurement, if it helps to improve security of supply and availability of the product or the availability and accessibility of the product, as applicable.
• Further, nine or more Member States may request the Commission or the Commission may initiate on its own initiative.
• The difference to procurement under Article 22 CMA is that this route is intended for the implementation of joint actions, administered jointly by the Commission and the Member States, such as under the EU4Health programme.

3. Looking ahead

Obviously, the CMA is currently only a draft awaiting the legislative procedure.  The HERA review touches on some aspects of joint procurement and highlights its role in the negotiation of contracts under the CBTH Regulation.

In addition, the Preparedness Strategy highlights a couple of points:

• The European Parliament has proposed changes to the EU pharma law package, which also touch on procurement.  Specifically, the proposed changes introduce:
  • a requirement for the Commission to issue guidelines on the implementation of the most economically advantageous (MEAT) requirement and with a view to discouraging single-winner and price-only tenders,
  • a subscription model for joint procurement of antimicrobials,
  • optional joint procurement for centrally authorized products.

• The Commission intends to present a “Strategy to support medical countermeasures against public health threats to strengthen the EU’s health security, reinforce EU competitiveness, and protect the public from cross-border health threats, including chemical, biological, radiological and nuclear (CBRN) threats.”  This Strategy is intended to supplement the CMA.

• The Commission intends to propose a revision to the public procurement framework, which should also take into account the “lessons learnt” from the COVID-19 pandemic.  The proposal will focus on preparedness and ensuring security of supply, including in crisis situations.  The Commission recently consulted on the effectiveness of the current regime.