kom (2025) 0529 - Ingen titel

Europaudvalget 2025
KOM (2025) 0529
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EUROPEAN

COMMISSION

Brussels, 9.7.2025

COM(2025) 529 final

ANNEXES 1 to 2

ANNEXES

to the

Communication from the Commission to the European Parliament, the Council, the

European Economic and Social Committee and the Committee of the Regions

Preparing the EU for the next health crisis : a Medical Countermeasures Strategy

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ANNEX 1: 2025 Health Threat Prioritisation

assessment for medical countermeasures

The purpose of the Commission’s 2025 Health Threat Prioritisation assessment for

medical countermeasures (MCMs) is to identify serious cross-border health threats that

necessitate targeted action at EU level to support access to and availability of MCMs,

including research and development, procurement, stockpiling and distribution.

The process of prioritising threats, once consolidated and taking into account stakeholder

feedback, will play a pivotal role in prioritising future EU action on medical

countermeasures. The 2025 Health Threat Prioritisation assessment gives an overview of

the most relevant health threats and the related MCMs, drawing on current knowledge

and expertise. Building on previous assessments, which were developed in close

collaboration with the Health Emergency Preparedness and Response Authority’s

(HERA) Board, HERA Advisory Forum, Commission services and EU agencies, this

assessment provides a foundation for understanding public health threats and identify

needs for MCMs.

Threat prioritisation is a dynamic, consultative, and iterative process that continuously

evolves. This assessment serves as a foundation for outreach and engagement with key

stakeholders, including Member States, other EU institutions and the professional and

scientific medical countermeasures community. It will facilitate a coordinated and

effective response to emerging threats. Building on this input, the Commission plans to

publish it in late 2025 as a Staff Working Document, and to update it by 2027 at the

latest.

The 2025 Health Threat Prioritisation assessment identifies four major threat categories

that can be addressed by means of MCMs:

•

Respiratory or contact-based viruses with pandemic potential –

highly

transmissible viruses with a history or likelihood of causing large-scale outbreaks

and influenced by e.g. biodiversity loss;

Vector-borne or animal-reservoir viruses with epidemic potential –

viruses

whose spread is accelerated because of climate change and other environmental

factors, which are qualified as a specific threat category due to its growing

relevance for the EU, the fastest warming continent;

Antimicrobial resistance (AMR);

a rising global concern that threatens the

efficacy of existing treatments and increases the burden of infectious diseases;

Armed conflict related threats and chemical, biological, radiological and

nuclear (CBRN) threats.

•

Informed by European and global activities, including work carried out by the World

Health Organization (WHO), the European Centre for Disease Prevention and Control

(ECDC) and other global health institutions, the assessment prioritises 12 families of

viruses with pandemic and epidemic potential. It also examines the latest developments

in antimicrobial resistance trends, analyses emerging CBRN threats, and examines the

impact of climate change on the spread of infectious diseases.

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IRAL FAMILIES OF EPIDEMIC AND PANDEMIC CONCERN

HERA’s prioritisation process took into account existing scientific and epidemiological

assessments, integrating global and EU-level frameworks, including from WHO and the

ECDC. The methodology used assesses the pandemic potential, the likelihood of an EU-

wide public health emergency, the availability of MCMs, and the impact of climate

change on the spread and severity of viral threats.

The assessment identifies two groups of viral families of epidemic and pandemic concern

that can be addressed by means of MCMs:

Group 1:

viral families of highest priority,

which pose the most immediate and

severe risk to the EU and global health security;

Group 2:

viral families of high priority,

which present serious but slightly lower

levels of immediate threat.

1.1. Respiratory or contact-based viruses with pandemic potential

1.1.1.

Group 1: Viral families of highest priority

Coronaviridae,

including SARS-CoV, MERS-CoV and SARS-CoV-2, remain a concern

due to their airborne transmissibility, their ability to cause severe disease outcomes, their

capacity for human-to-human transmission, relatively rapid mutation rate, and potential

for immune escape, including reduced effectiveness of vaccines and some therapeutics

against emerging variants. There are no licensed vaccines or treatments for SARS-CoV-1

or MERS-CoV, and overall availability of medical countermeasures remains variable.

Orthomyxoviridae,

including Influenza A subtypes such as H1, H2, H3, H5, H6, H7 and

H10, comprise both seasonal and potentially pandemic influenza viruses. These viruses

are a concern as they mutate frequently (antigenic drift), reassort rapidly (antigenic shift),

and have historically caused global pandemics. Although vaccines against seasonal

influenza and certain strains of zoonotic influenza are available, their efficacy is limited

by antigenic variability, and may not provide protection against novel pandemic strains.

Filoviridae,

including the Ebola and Marburg viruses, are a concern due to their

association with severe haemorrhagic fevers, high case fatality rates, and their potential

to cause large-scale outbreaks, particularly in sub-Saharan Africa. Sporadic imported

cases remain a concern, and while vaccines and monoclonal antibody-based therapeutics

targeting Zaire ebolavirus are licensed – none for Sudan ebolavirus or Marburg virus –,

challenges remain in terms of equitable access, production scalability and swift

deployment, particularly in outbreak settings.

Poxviridae,

including the monkeypox (causing mpox) and variola virus (causing

smallpox), remain a concern in the context of bioterrorism and accidental release, but

also in view of the possible emergence of new, more virulent mpox strains. Existing

vaccines provide partial cross-protection, and limited availability of effective therapeutic

options remain as important challenges.

1.1.2.

Group 2: Viral families of high priority

Paramyxoviridae,

including the Nipah virus, pose a concern due to high fatality rate and

zoonotic potential. Although not currently a threat within the EU, climate change and

While the Corona- and Orthomyxoviridae families mark this category with their well documented

pandemic potential, the other viral families in this category typically exhibit epidemic rather than

pandemic potential, largely owing to differences in transmission dynamics.

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habitat disruption are altering bat migration and habitat patterns, increasing the likelihood

of spillover events. No authorised vaccines or specific treatments are currently available.

Picornaviridae,

including poliovirus and enteroviruses D68 and A71, remain a concern

due to the risk of wild-type or vaccine-derived polio outbreaks. While effective polio

vaccines are available, no authorised treatments exist for non-polio enteroviruses.

1.2. Vector-borne or animal-reservoir viruses with epidemic potential

Viral families in this category are of increasing concern for Europe because climate and

environmental changes are highly dynamic drivers of their spread, divided according to

the same criteria, into group of highest and high priority in relation to MCMs.

1.2.1.

Group 1: Viral families of highest priority

Flaviviridae,

including the dengue, West Nile, tick-borne encephalitis, Yellow Fever,

Zika, and Japanese encephalitis viruses, are a growing concern due to vector-borne

transmission and the expanding range of mosquitoes and ticks, driven by climate change.

While vaccines exist for some flaviviruses, treatment options are limited, and the number

of cases originating locally is increasing in parts of Europe.

1.2.2.

Group 2: Viral families of high priority

Togaviridae,

including the chikungunya and Venezuelan equine encephalitis viruses,

pose a threat due to severe disease outcomes and their potential for rapid geographic

spread. While newly authorised vaccines for chikungunya represent major progress in

treating these viruses, most viruses of this viral family, like Venezuelan or Eastern equine

encephalitis viruses, currently lack medical countermeasures.

Arenaviridae,

including the Lassa, Junin and Lujo mammarenaviruses, as well as

Hantaviridae,

including Hantaan and Sin Nombre viruses, are zoonotic pathogens

maintained in rodent-reservoir hosts, and are associated with viral haemorrhagic fevers

and significant epidemic potential. No vaccines or specific treatments are currently

authorised in the EU.

Phenuiviridae,

including severe fever with thrombocytopenia syndrome (SFTSV) and

Rift Valley fever viruses (RVFV), pose a threat due to their capacity to cause severe

disease and large-scale outbreaks. SFTSV is primarily transmitted by ticks, while RVFV

is transmitted by mosquitoes, particularly

Aedes

and

Culex

species. No vaccines or

specific antiviral treatments are currently authorized in the EU.

Nairoviridae,

including Crimean-Congo haemorrhagic fever virus (CCHFV), are of

growing public health concern, and are already endemic in parts of southern and eastern

Europe. CCHFV is primarily transmitted by

Hyalomma

ticks, whose range is expanding

due to climate change. Currently, there are no authorised vaccines or specific antiviral

treatments available in the EU.

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Figure 1. Overview of prioritised viral families, including a partially semi-quantitative mapping of relevant attributes. The information is primarily based on

publicly available sources;.

(Disclaimer: This figure is intended for general informational purposes only and does not constitute legal, medical, or professional

advice.)

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NTIMICROBIAL RESISTANCE

Antimicrobial resistance (AMR) continues to grow as one of the most pressing global health

threats, undermining the effectiveness of existing treatments and increasing the burden of

infectious diseases through higher morbidity, mortality and healthcare costs. Without urgent

action, AMR is projected to become a leading cause of death worldwide by 2050, with annual

fatalities potentially reaching 10 million people.

In 2021, AMR contributed to 4.71 million deaths globally, with 1.14 million directly

attributed to resistant infections. In the EU/EEA, over 35 000 deaths occur every year due to

AMR infections, disproportionately affecting infants, older people and immunocompromised

people. The COVID-19 pandemic exacerbated antimicrobial resistance, as the increased use

of last-resort antibiotics led to a rise in multidrug-resistant bacterial and fungal infections.

The WHO, with support of HERA, updated the AMR pathogen prioritisation at global level,

including the (i)

WHO Bacterial Priority Pathogens List 2024

and (ii)

WHO Fungal Priority

Pathogens List 2022.

The assessment highlights key bacterial priority pathogens, including

rifampicin-resistant

Mycobacterium tuberculosis.

It also emphasizes that

rifampicin-resistant (RR), multi-

resistant (MDR)

and

extensively-resistant (XDR) tuberculosis,

continue to remain a critical

challenge especially in high-burden regions. It also identifies

Enterobacterales

resistant to

third-generation cephalosporins,

as top priorities. In addition, ECDC surveillance data

further underline increasing and concerning resistance trends in

carbapenem-resistant

Enterobacterales

and

vancomycin-resistant

Enterococcus faecium.

Lastly, the increasing

rates of AMR in

N. gonorrhoeae

in the EU, and the emergence of

extensively drug-resistant

N. gonorrhoeae,

are a major global public health concern.

The

antibiotics

pipeline analysis notably shows that while the number of antibacterial agents

in clinical development increased in 2023, it is not sufficient to address serious infections and

to complement antibiotics that are becoming ineffective due to AMR. The current pipeline

continues to show a

major gap in antibacterials with activity against metallo-β-lactamase

(MBL) producers,

while the prevalence of those enzymes in resistant pathogens is

increasing. Alternative to antibiotics such as the use of

bacteriophages

and

monoclonal

antibodies

may serve as alternative treatment options in the near future.

Finally,

fungal priority pathogens,

including

Cryptococcus neoformans, Candida auris,

Aspergillus fumigatus,

and

Candida albicans

require attention as they pose a growing threat

due to their multidrug resistance, particularly to immunocompromised patients.

The 2023 WHO antibacterial pipeline highlights a shift towards the development of narrow-

spectrum antibacterials which will likely require an increased use of

rapid diagnostics

ensure these narrow-spectrum products are used in the correct patients.

Both

vaccines

against viral and bacterial infections can contribute to reducing the spread of

infections and AMR by preventing the need for a treatment with antimicrobials. Although,

new vaccines are under development, vaccines against high priority bacterial pathogens are

still

missing.

Beyond the insufficient innovation, the

lack of availability of certain antibiotics in the EU

has the potential to worsen the AMR threat, either by causing a direct risk for the patients, or

by hindering the proper use of antibiotics and consequently promoting AMR emergence and

spread.

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Against this multifaceted and complex threat, a wide arsenal of MCM is necessary, which

currently suffers from both lack of innovation and access, requiring a multifaceted approach,

combining push and pull interventions to ensure both the development of novel antibacterials,

as well as the availability and access of both new and old antibacterials, and other MCM. This

is complemented by work of the ECDC and other ongoing Commission work strengthening

surveillance and promoting AMR stewardship and responsible use.

CONFLICT

RELATED THREATS AND CHEMICAL

BIOLOGICAL

RADIOLOGICAL

AND NUCLEAR

(CBRN)

THREATS

RMED

Assessing preparedness for chemical, biological, radiological and nuclear (CBRN) incidents

is a key component of the work to boost the EU’s health security. Russia’s war of aggression

against Ukraine and the overall more volatile geopolitical situation have heightened the need

for preparedness in this area.

The assessment provides an overview of current CBRN threats and also covers emerging

threats and the medical countermeasures that can be used against these threats. The

assessment covers the availability of medical countermeasures for all priority CBRN agents,

as well as gaps and medical countermeasures under development It is developed in close

consultation with civil authorities in Member States through an iterative process. This

assessment contains classified information, due to its sensitive nature, and is not publicly

available. Identified threat include:

Biological agents,

including anthrax, smallpox, haemorrhagic fevers and plague. These

pathogens, known for their high case fatality rates, potential for weaponisation and social

disruption, remain the primary focus for biodefense initiatives.

Chemical warfare agents,

including nerve agents, blister agents, pharmaceutical-based

agents and vesicants. They were used during the civil war in Syria and in targeted attacks in

Europe and Asia over the past decade.

Biotoxins,

covered by both the Chemical and Biological Weapons Conventions, and at the

intersection of biological and chemical agents. There have been several incidents involving

biotoxins in Europe since 2018, including in Germany, Norway and the UK, underscoring the

need for more medical countermeasures to protect from and treat biotoxin exposure and

injury.

Emerging biological and chemical threats.

Biotechnology and computational chemistry are

progressing rapidly, presenting promising advancements in the development of medicines but

also bringing potential threats.

Radiological and nuclear threats.

These threats are an increasing concern in Ukraine and

the EU. The situation is especially concerning around the Zaporizhzhya nuclear power plant.

By setting up rescEU, a strategic reserve of disaster response capabilities, the Commission has

made substantial progress in stockpiling personal protective equipment, detection and

decontamination tools, vaccines and therapeutics needed in the event of a CBRN incident.

Additional efforts are ongoing to quantify potential needs for medical countermeasures for

selected threats in the event of an incident involving each agent.

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ANNEX 2: EU strategic plan for stockpiling of medical countermeasures

Introduction

The EU Strategic Plan for Stockpiling Medical Countermeasures (“the strategic plan”) is a

pillar of the EU’s Medical Countermeasures Strategy’s

end-to-end approach. It establishes

a comprehensive and proactive framework to strengthen preparedness and rapid response to

health emergencies via stockpiles of medical countermeasures (MCMs).

Building upon the Niinistö report

, the Preparedness Union Strategy

and the EU Stockpiling

Strategy

, the strategic plan will contribute to

strengthening access

to critical resources

across the EU, in the area of medical countermeasures. The strategic plan builds upon the

lessons of response to COVID-19 and of the current medical and chemical, biological,

radiological, and nuclear (CBRN) rescEU stockpiles. The strategic plan proposes actions to

enhance the current framework and will be used as a tool to guide future decisions.

Establishing stockpiles of medical countermeasures at EU level means creating and managing

a strategic capability with a

specific focus on global or Europe-wide public health

emergencies

to protect EU citizens. Strategic stockpiles of medical countermeasures

act as

an insurance

and allow gaining time in the event of a health crisis, mitigating its economic

and social costs. This work aims at complementing Member States’ national stockpiles and

global efforts in order to ensure a cost-effective approach that enhances solidarity in the

European Union in the event of a health crisis

Although the EU and national stockpiles are established to address local and regional risks, on

occasions, they have also been deployed to

show global solidarity

to mitigate threats in third

countries (and to prevent further spread beyond these). Despite the regional focus,

complementarity with globally held stockpiles is equally relevant. This layered approach is

not only important to ensure complementarity, but also to avoid market disruptions.

Over the past few years, the European Commission has significantly enhanced its ability to

anticipate, prepare and respond to disasters and crises, notably through the

establishment of

rescEU,

a pioneering strategic reserve of European disaster response capabilities and

stockpiles, fully funded by the EU. This initiative has provided a critical safety net, enabling

the EU to respond swiftly and effectively in times of crisis. To date, the Commission has

invested €1.65 billion and created 22 specialised medical and CBRN countermeasures

stockpiles, strategically located across different Member States.

These stockpiles bolster the EU’s collective response capacity and have helped to address

critical gaps in national response capabilities, particularly in situations across different

Member States or where national response capabilities are insufficient, inadequate, or

unavailable. The value of this investment has been demonstrated by the successful

deployment of these stockpiles in response to high-pressure situations, such as the mpox

outbreaks and the geopolitical tensions triggered by Russia's invasion of Ukraine,

underscoring the EU's commitment to protecting its citizens' health and well-being in the face

of emerging threats.

The lessons from this investment show that

stockpiling medical countermeasures is

significantly more complex

than storing non-perishable items. This complexity stems also

Safer together: A path towards a fully prepared Union - European Commission

Joint Communication to the European Parliament, the European Council, the Council, the European Economic and Social

Committee and the Committee of the Regions on the European Preparedness Union Strategy, JOIN(2025) 130 final of

26.03.2025

EU Stockpiling Strategy COM(2025)528

In line with Art 222 TFEU.

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from strict regulatory requirements for medical countermeasures and market viability

challenges. These are further compounded by the

unique characteristics

of medical

countermeasures - their high value, need for technical expertise, stringent security measures,

demanding logistical needs, such as storage conditions and shelf-life constraints, and

deployment constraints, such as specific customs rules. This distinguishes stockpiling of

medical countermeasures, in many instances, from non-medical stockpiles such as emergency

shelters or generators.

Strategic stockpiling is done both by the

military and civilian

sectors, with a need to align

preparedness strategies. Military expertise is also required as stockpiles may be subject to

external physical and digital disruption or destruction, being considered dual-use assets and

therefore potential targets.

The

key objective under this strategic plan

is to ensure the efficient and effective

stockpiling of relevant medical countermeasures that can address the threats identified in

Annex 1 of the EU’s Medical Countermeasures Strategy (viruses with pandemic or epidemic

potential and chemical, biological, radiological and nuclear threats) so as to secure their

timely availability and access in time of emergency as a concrete example of European

solidarity in the event of health crisis.

Building on lessons learnt from

rescEU

implementation, the plan seeks to identify and

implement actions to ensure a comprehensive management of the stockpiling of medical

countermeasures. It encompasses detailed

processes for

identifying

essential

medical countermeasures,

determining

necessary quantities

and the potential

need for replenishment (section 1),

followed by

effective procurement

strategies, which also include the use of

joint procurement as a cost-effective tool

for strengthening national stockpiles

(section 2). The plan also outlines

elements to strengthen the

efficient

management

(section 3) of these stocks

to guarantee readiness and timely access

during emergencies as well as a

deployment

strategy (section 4), which

includes streamlined request processes, efficient transportation, and clear procedures for

receiving States.

The strategic plan feeds into the discussion on future funding, considering that there is no

further budget allocated to expand or maintain the established EU stockpiles under the current

multiannual financial framework (MFF). Building-up a strategic stockpile takes a

long-term

commitment

and requires sustainable funding to be prepared for future crises

. In this

respect, factoring stockpiling considerations in the EU budget programmes from the start,

may help reduce vulnerabilities and exposure to risks, reducing the cost of potential remedial

action.

As a reference, the US has invested between 2014 and 2024 on a yearly basis between $534 million and $995 million for

their strategic national stockpile of medical countermeasures, and additionally between $225 million and $830 million

annually for their Bioshield project, which also allows them to purchase countermeasures which are not yet on the

commercial market, but under development (The

Strategic National Stockpile: Overview and Issues for Congress |

Congress.gov | Library of Congress)

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STRATEGIC STOCKPILE ASSESSMENT – DETERMINING THE NEEDS FOR

EU STOCKPILES OF MEDICAL COUNTERMEASURES

To ensure the availability and rapid deployment of relevant medical countermeasures

during health crises, it is essential to establish a coordinated EU-level system for the

identification and quantification of medical countermeasures to be stockpiled.

Until now, the items stockpiled in rescEU have been proposed by the Member States based on

a priority list established by the Commission. In the future, to ensure alignment with the

HERA threat assessment and facilitate effective planning, the Commission, in close

collaboration with Member States,

intends to propose items and quantities

for stockpiling

based on the methodology described below.

Indeed, Annex 1 of the

EU’s Medical Countermeasures Strategy identifies the pathogens

or agents

that have the potential to cause public health emergencies and require EU

interventions in the area of medical countermeasures. Beyond the likelihood of these threats

materialising and their potential impact on health, it assesses the adequacy of the current

medical countermeasures arsenal to respond to these threats, focusing on the availability of

vaccines and therapeutics.

Since 2020, the Commission

has worked with Member States

to identify priority items for

the rescEU stockpiles. A common and layered strategic approach to stockpiling was

presented

, to ensure adequate emergency reserves managed at sub-national, national, and

regional levels, complemented with EU level reserves. Different practices were exchanged

during workshops and training that took place over time. These inputs were compared with

international practice concerning the creation of strategic stockpiles for health crises.

Building upon that experience and the existing stocks, a

new approach

was developed

leading to the process and criteria outlined in the section below.

1.1. A methodology to identify the medical countermeasures for EU stockpiling

The Commission will develop

a methodology by 2025

to assess which threats and medical

countermeasures would be suitable for EU stockpiling as a relevant and cost-effective

intervention to enhance EU preparedness and response, while ensuring that the quality,

efficacy and safety standards meet the requirements of the EU regulatory framework.

The Commission will conduct an assessment that will result in a

compendium

of selected

medical countermeasures, using a set of predefined

criteria to identify and prioritise

those

to be stockpiled at EU level. The main criteria could be:

•

Potential impact:

this criterion assesses the likely impact of the medical

countermeasures on the response to serious cross-border health threats, if made

accessible rapidly. This criterion considers the characteristics, existing evidence of the

considered product (e.g. safety, efficacy, etc.) or the availability or absence of

potential alternative products. Where a product has received approval from a stringent

regulatory authority and is deemed essential for an effective response, the absence of

EU authorization alone should not prevent its consideration for stockpiling.

Time-Critical Effectiveness:

this criterion assesses whether the considered medical

countermeasures effectiveness will be conditioned to a quick deployment.

•

Background paper for the HERA Board -common

strategic approach to stockpiling - final version

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•

Redundancy:

this criterion assesses whether other instruments or systems already

exist to ensure access to the considered medical countermeasures, such as national

stockpiles or other EU instruments then stockpiling, such as joint procurement.

Market failure/limitations:

this criterion assesses whether the existing (commercial)

market ensures access to the concerned medical countermeasures outside and during

emergencies, or whether public intervention is necessary.

Production capacity:

this criterion will identify products that have limited production

capacity or scalability, or other vulnerabilities in the supply chain that could lead to

unacceptable delays in time of crisis.

•

In cases where multiple medical countermeasures are available to address the same cross-

border health-threat or indication, the identification process could include additional criteria

such as:

•

EU strategic autonomy:

this criterion will assess whether the supply chain for the

considered medical countermeasures presents vulnerabilities, notably whether the EU

is highly dependent on supply chains outside the EU. The EU strategic autonomy in

crisis response is crucial even more so in the light of the current geopolitical tensions,

i.e. medical countermeasures with EU-controlled manufacturing capacities and supply

chain will be prioritised to strengthen strategic preparedness and reduce reliance on

third countries during global health emergencies.

Operational considerations:

medical countermeasures of similar quality, safety and

efficacy could be prioritised, for instance according to how they fit international

guidelines on national healthcare capabilities, national preparedness plans and

emergency response logistics. In addition, factors such as storage conditions, like

temperature control, special handling conditions and shelf-life could be considered.

For instance, among similar medical countermeasures with different shelf-life those

with longer shelf-life should be preferred, as they reduce the need for frequent stock

rotation and minimise waste.

•

The same methodology will be applied to inform strategic decisions about

re-procurement.

The approach should be tailored to the specificity of the medical countermeasure. While some

therapeutics may need to be restocked immediately, it may be different for others in case the

cross-border health threats situation has changed. For high impact - low probability threats,

the replenishing can increase production and ensure continuity of supply.

The Commission will propose to Member States a compendium of medical

countermeasures suitable for EU stockpiling, in Q3 2025.

Among the medical countermeasures identified for potential EU stockpiling, certain ones,

particularly those comprising antidotes against chemical agents, require administration as

soon as possible after exposure, and must be available close to the intervention site. In such

cases, there is the need for these medical countermeasures to be

available at local, regional

or national level.

Furthermore, medical kits can provide added value in scenarios such as

mass casualty events, where multiple medical countermeasures for wound management, burn

treatment or trauma care are simultaneously required.

However, under rescEU, the pre-positioning of stocks can only be requested in exceptional

situations of increased risk, as it was the case during the 2024 Olympic games in Paris or the

2023 Rugby World Cup. With the current geopolitical tensions, the

need for pre-positioning

certain medical countermeasures

might increase

to ensure immediate treatment.

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In the future, the Commission could propose the procurement and pre-positioning of

“EU

medical countermeasures kits”

in each Member State, including overseas departments, to

ensure rapid initial responses to serious health threats at both national and EU levels, in

accordance with the EU solidarity. These kits would contain a range of medical

countermeasures, which would be stored in a manner that allows for a swift deployment,

either as a complete kit or as individual components to meet the needs of a rapidly evolving

health crisis.

The Commission will conduct meetings as of 2025 with Member States to discuss the

relevance, the composition and location

of such kits

. This discussion is crucial, as the kits

will need to be useful for different national context. Additionally, the Commission will

explore with the receiving Member States if the management of the kits is feasible in terms of

labelling, transportation, regulatory considerations, security, and ensuring compatibility with

regional healthcare systems and infrastructures.

The Commission will explore different

possibilities to procure such kits.

The kits could be

centrally procured, after which the recipient Member States would determine where best to

store and manage them. Additionally, to improve national preparedness and complement the

EU stockpile, the pertinence of organising joint procurement for EU emergency kits will be

considered together with Member States, as national preparedness is in the first place a

national responsibility

The Commission, together with Member States will explore possibilities of the

composition, location, and procurement of EU medical countermeasures kits.

1.2.

Identification of potential stockpiling advance purchase commitments

Since threats and response capacities develop over time, the compendium needs to be

reviewed regularly, including when health threat specific plans are published or revised. The

Commission is building on its work of the

medical countermeasures preparedness

roadmaps

for specific health emergency scenarios

. These operational plans will identify

what steps are needed at EU-level to ensure availability of medical countermeasures for

priority threats and function as adaptable blueprints for crises. The first set of plans is

expected to be completed by 2026. Therefore, it should be assessed in 2026 if (future)

strategic stockpiling would be a suitable instrument for the pipeline candidates, considering

alternatives like capacity reservation contracts.

The Commission will establish a list of medical countermeasures candidates suitable for

advance purchase commitments in the EU strategic stocks, with consultation of the

European Medicines Agency (EMA), in 2026.

1.3. Quantification and information exchange

Upon establishment of the compendium of medical countermeasures suitable for potential EU

stockpiling, the Commission will use specific criteria to determine the

optimal quantities

for

stockpiling. In doing so, the Commission will engage closely with Member States, without

prejudging future budget decisions.

This includes the consideration for preparedness for armed conflict, as highlighted in section 5.2 of the EU’s Medical

Countermeasures Strategy

As highlighted in section 2.1 of the Medical Countermeasures Strategy

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The

quantification of medical countermeasures

will be on priority scenarios such as

pandemics, industrial/laboratory accidents, transportation incidents, climate-related events,

food/water contamination, intentional events, terrorist threats, state-sponsored events or

hybrid attacks, and conflicts. It will consider the existing national, EU and global

preparedness plans or other strategies that Member States aim to implement in response to

these scenarios.

Where necessary, modelling capacities will be mobilised to determine the quantity of medical

countermeasures that could significantly decrease the health burden in such scenario, if

stockpiled at EU level. In addition, the estimation of quantities will consider:

•

The type of threat (i.e. spread likelihood, severity, duration),

The estimation of affected population including vulnerable population (i.e. elderly,

children, pregnant women, etc.)

The use of medical countermeasures (e.g. dosage, duration of treatment).

To be able to determine the appropriate quantities for an EU-level reserve, a critical element

is the

collaboration with Member States and the exchange of classified information

national needs and capabilities. When defining quantities, it is important to consider in the

exchange of information with Member States their contingency stockpiling obligations.

To overcome these challenges and make informed decisions, the Commission facilitates

discussions, with Member States in a classified format. IT tools supporting this exchange will

be enhanced, which will also support forward planning for stockpiles.

The Commission will present in a classified format draft quantification for EU

stockpiling of medical countermeasures to Member States for their input, in Q1 2026.

To further strengthen the information exchange, the Commission will need to tackle several

challenges, including

sensitivity of information

and the lack of

comprehensive data-

sharing mechanisms.

Member States are cautious about sharing sensitive data due to security

concerns, while private companies hesitate to disclose inventory levels or supply-chain data

for competitive reasons. Additionally, the disparity in preparedness among Member States

might create fragmentation, making it difficult to establish a stockpiling at EU level.

The Regulation on serious cross border threats to health

requires Member States to report on

the capacity that Member States have in place to be ready for a public health emergency,

including arrangements aimed at ensuring the continuous delivery of critical services and

products, such as stockpiles of medical products. The Commission could consider options to

strengthen reporting requirements.

PROCURING FOR THE FUTURE: A FLEXIBLE AND RESILIENT APPROACH

TO THE ESTABLISHMENT OF STOCKPILING

EU preparedness and response to health emergencies can also be enhanced by refining

procurement strategies for medical countermeasures stockpiles, prioritising centralised

purchases, stockpiling of unfinished products, non-EU authorised and investigational

medicinal products to ensure flexibility, resilience, and strategic autonomy.

Budget implementation methods directly influence the effectiveness, efficiency, and

sustainability of the stockpiling of medical countermeasures, making it a critical component in

Regulation (EU) 2022/2371 of 22 December 2022 on serious cross-border threats to health.

kom (2025) 0529 - Ingen titel

preparedness and response strategies. Looking ahead, the Commission is committed to

refining and advancing the procurement strategies

for EU medical countermeasures

stockpiles to maximize their impact.

2.1. Stronger coordinating role for the Commission

Thus far, the Commission has established EU medical countermeasures stockpiles through

grants,

where the Member States become grant holders and are responsible for the purchase,

management and deployment of the stocks as owner of the stocks. The

advantage of using

this forms of grants

is that they enable a comprehensive arrangement whereby all aspects of

the process, from purchase to deployment, are managed under a single agreement

At the same time, with several grants holders in charge of the purchase, there is the risk that

different buyers reach out to the same company,

causing a surge in demand

that the

company may struggle to meet, resulting in

delayed deliveries, higher prices, or stockouts.

By better coordinating medical countermeasures purchase plans and providing visibility into

demand, the stockpiles holders can optimize the purchase of medical countermeasures, reduce

inefficiencies, and ensure a more reliable supply chain.

The Commission will take a stronger coordinating role in future stockpiling

procurements, which will be based on the compendium.

2.2. Procurement of unfinished products

Stockpiling unfinished products would ensure that the stockpiled medicines are suitable for

long-term storage and customised

to the specific emergency use. It would provide for a

more flexible response as more final products can be manufactured when required.

Additionally, if all the processes within the supply chain take place in the EU, it could

strengthen the EU’s resilience and strategic autonomy. For a production capacity to ramp up it

is essential to have advanced pharmaceutical ingredients, excipients, packaging and

manufacturing facilities.

Exploring different options along the different production stages may help also to extend

shelf-life as certain “pre”-products are often more stable compared to the finalised product.

Examples of different unfinished products include:

•

Stockpiling of raw materials, excipients, active pharmaceutical ingredients (APIs)

and their intermediates,

suitable if the emergency lasts for a longer period.

Stockpiling in bulk,

for instance for vaccines, with vials quickly filled once there is a

need. 

Lyophilisation,

i.e., freeze-drying of a product, often suitable for vaccines.

However, the management of these stockpiles

requires specific arrangements

such as

transport, manufacturing capacities, access to additional ingredients, etc. It is therefore

important to establish the intended use of such stockpiles of ingredients.

Currently, is not possible to stockpile unfinished products under rescEU, given the need for

swift deployment.

An innovative approach to stockpiling is emerging, one that

combines the long-term storage

APIs with flexible, continuous manufacturing processes to produce finished dose forms.

This new concept has the potential to transform the EU's stockpiling system, making it more

cost-effective, less wasteful, and more responsive to health emergencies.

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By storing APIs under optimal conditions, it is possible to maintain their physical and

chemical stability for up to 20 years, depending on the ingredient. When paired with a

compact, modular, and flexible continuous manufacturing platform, this approach enables the

rapid production of medical countermeasures

in response to emerging health threats. This

decentralised network can be established across EU, providing a resilient and adaptable

manufacturing capacity that can be quickly scaled up or down as needed. The benefits of this

approach are numerous such as cost savings, increased flexibility, improved sustainability and

enhanced resilience.

This action could be aligned with:

•

EU FAB to provide EU with a manufacturing capacity reservation beyond vaccines

and provide the infrastructure with an activation system under the Emergency

Framework Regulation.

Civil-military interactions to provide an infrastructure able to respond to a range of

threats.

The Commission, in collaboration with Member States, will conduct a pilot study on the

benefits and added value of stockpiling unfinished products at EU level in 2026.

2.3. Procurement of non-EU authorised and investigational medicinal products

The current rescEU legislation does not address the stockpiling of

investigational medicinal

products

and of medical countermeasures that

lack marketing authorisation

or a

recommendation for compassionate or emergency use from EMA or a Member State

In the absence of such stocks, there is a risk that the relevant products will not be available

when a public health crisis emerges, or in case of high-risk events relating to chemical,

biological, radiological and nuclear threats.

Despite the potential strategic value of such medical countermeasures, the lack of

authorisation in the EU may stem from factors such as

a limited or unpredictable market,

high production costs, or burdensome post-marketing obligations.

This also prevents the quick deployment of non-authorised products that are often under

clinical investigation, to outbreaks, where they could also facilitate clinical trials and

ultimately support the future authorisation of much-needed medical countermeasures, such as

those for haemorrhagic fevers.

Although from a health security and reputational point of view, it is strongly recommended to

stockpile medicines authorised in the EU (and therefore it is important to incentivise

developers to obtain marketing authorisation for the countermeasures before they are

stockpiled), for some health threats this may not be possible.

To address this gap, the Commission has proposed in the revision of the pharmaceutical

legislation new tools, like the temporary emergency marketing authorisation to further

faciliate authorisation of medical countermeasures in the EU, and

will facilitate the

implementation of flexibilities stemming from the current and future legislations..

For investigational products, the Commission will also consider how it could be possible to

secure stocks of medical countermeasures that present a strategic interest as regards emerging

threats, through

funding for their research and development.

A pharmaceutical form of an active ingredient being tested or used as a reference in a clinical trial

Annex vi of https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A32020D0414

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The Commission, in collaboration with the Member States and the European Medicines

Agency, will assess how purchase of unauthorised or investigational medicinal products

can be further faciliated.

BUILDING RESILIENCE THROUGH SUSTAINABLE AND PROACTIVE

STOCKPILE MANAGEMENT

Enhancing EU emergency preparedness and response can be further achieved by

establishing a centralised, sustainable, and cost-effective management framework for

medical countermeasure stockpiles, which integrates IT tools for real-time tracking,

implements shelf-life extension programmes, and fosters collaboration among

stakeholders to ensure operational efficiency and proactive crisis readiness.

Good stockpile management

strengthens the sustainability and cost-effectiveness

of the

stockpiled items. A common set of principles and clear governance for the management of

medical countermeasures stockpiles across the EU should be established to ensure consistency

and increase the efficiency, safety and security of the stocks.

Indeed, stocks of medical countermeasures must be operated and managed under strict

regulatory controls,

necessitating a high level of oversight to ensure full compliance with

pharmaceutical legislation and good management practices. Additionally, attention must be

paid to the specific management of the stocks, such as the management of the shelf-life, the

special storage conditions, the interoperability of the items, the labelling, the packaging, the

rotation and the waste management, without forgetting the management of the security of the

stocks. This makes the medical countermeasures stock management a

different expertise

from non-medical stockpiles.

The current management of the stockpiles, with different grant holders acting independently,

results in different approaches which may affect both the composition, the management and

the deployment of the stocks. For instance, while the grant holders are fully responsible for

the warehouses, they have different approaches as regards the management of the stockpiles,

with different stakeholders involved, such as public/private partnerships, partnerships with

different national authorities and agencies, partnerships with military, civil protection and

other actors.

3.1. Exchange of information

To manage the rescEU stockpiles, the Commission needs a comprehensive overview of all

items, at every stage of the process. This encompasses items that are yet to be procured as

well as those currently in the procurement process. The overview of all the items should be

kept in a secure database. This starts with

effective IT tools

for stockpile management. They

are crucial for ensuring accuracy and real-time tracking of the stocks to avoid waste and

overstocking. Access to precise data and analytics improves decision-making especially in

time of deployment. Overall, IT tools for stockpile management are essential for maintaining

operational efficiency, reducing costs, and enhancing the ability to the demand effectively.

The stockpile manager should ensure interoperability with the Common Emergency

Communication and Information System

(CECIS 2.0), which integrates stocks, shelf-life,

early flagging of end of shelf-life and procurement planning to ensure a centralised vision of

the stock developments. This allows stockholders to move from reactive to proactive stock

management.

CECIS is web-based alert and notification application enabling a real-time exchange of information.

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Exchange of information and best practices amongst the stockpiles managers is also essential.

The Commission intends to facilitate a network of warehouses to share experiences,

guidelines, the use of IT-tools for management, and to train on specific good management

practices, such as sustainability tools, deployment, and use the network to create synergies

and improvements where desirable.

The Commission will facilitate a continuous exchange with the network of grant holders

of stockpiles on best practices, organise trainings, and create synergies.

3.2. Shelf-life extension programme

Because a stockpile functions much like an insurance policy—you invest in it for protection,

hoping you will never need to use it—some

items will inevitably expire and require

disposal.

This is an expected part of stockpile management, and the associated costs must be

factored into planning.

For those medical countermeasures that cannot be used outside of an emergency, such as

antidotes and certain vaccines, the Commission will work together with the Member States

and the European Medicines Agency, to pilot a

shelf-life extension

programme of medical

countermeasures which are currently in the rescEU stockpiles, and which are reaching the end

of their shelf-life. Shelf-life extension of selected medical countermeasures is a strategic

measure to enhance sustainability, reduce waste, and optimize stockpile management, while

also ensuring that the medical countermeasures still meet the regulatory standards. With

structured shelf-life extension programme, medical countermeasures could remain usable

beyond their initial expiration date, provided they undergo rigorous scientific testing and

regulatory oversight. This initiative, conducted in non-crisis periods, ensures that cost-

effective stockpiling practices support continuous emergency preparedness. The Commission

has already started such a collaboration for the current rescEU grants.

The Commission, European Medicines Agency (EMA) and grant holders have started to

implement a pilot on shelf-life extension programme for certain medical

countermeasures, with full roll-out in Q3 2026.

3.3. Other sustainable approaches to stockpiles management

Given the unique requirements of medical countermeasures, including shelf-life and storage

conditions, sustainability is a crucial aspect. When a medical countermeasure approaches one

year from expiry and its shelf life cannot be extended,

different sustainability approaches

must be considered by the stockpile manager.

The most sustainable way would be

stock rotation

– meaning when the end of shelf-life

approaches of a regularly used product it is replenished via normal supply chain, with

products with a longer shelf-life. This sustainability tool is possible in the current practice,

and procedures are predefined and pre-agreed in the grants preventing waste and maintaining

stock freshness. Implementation of this tool depends on legal elements such as national

marketing authorisation for the specific stocked formulation, and how the national

procurement of the specific good is arranged. Furthermore, it also depends on the size of the

EU stockpile, this might be larger than annual national usage of the routine product. As a

result, it is crucial to consider sustainability not only in stock management, but also

throughout all aspects of the process, including procurement.

For routine products with a short shelf-life, or personal protective equipment that is both

bulky to store and dispose of, a viable option is to procure these medical countermeasures

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through contracts with a specific manufacturer and have them stored by the manufacturer at

the manufacturer's premises. This arrangement, known as

Vendor Managed Inventory

is a

strategic reserve of a predefined quantity of selected medical countermeasures. Vendor

Managed Inventory can achieve several key objectives:

•

Guaranteed rapid access and availability of specific medical countermeasures when

required, 24/7 access.

The product is stored at the manufacturers warehouse in full compliance with

regulatory requirements and rotated through the manufacturer's normal sales /

distribution processes, hence the product never goes out of date and no need to

replace.

No replacement costs and no destruction costs.

It simplifies rotation for the routine products which serve as a safety net.

•

However, the manufacturer would have to have premises in the EU, and there are limited

manufacturers able to facilitate warehouse capacities. Within the grant agreements there is the

possibility for the grant holder to set-up a Vendor Managed Inventory, as long as the grant

holder remains the owner of the product.

If national rotation is not possible, asking consent for a

donation

(without an activation of the

Union Civil Protection Mechanism) is a possibility under Article 36 of the Union Civil

Protection Mechanism Implementing Decision

. In such a case, the logistics costs remain a

factor to be determined.

Ensuring the

security

of the stocks at their location and during transport is another crucial

element. When designing their stocks, stockpile managers will have to consider issues such as

access control, surveillance and monitoring, inventory management, physical security

measures, cybersecurity, fire and safety protocols, scenario planning and emergency response

planning.

STOCKPILING FOR SUCCESS: ENSURING TIMELY DEPLOYMENT AND EU

MINIMUM BUFFER FOR MEDICAL COUNTERMEASURES

Finally, effective response can only be achieved by ensuring timely deployment of the

medical countermeasures via resilient logistics services and compliance with the

regulatory requirements and by securing minimum buffer stocks at EU level.

4.1. Deployment tools

Timely and safe deployment

is a critical objective for effective emergency response and

patient care.

For the deployment of rescEU medical countermeasures stocks, the Union Civil Protection

Mechanism needs to be activated. This ensures that EU resources are utilized efficiently, and

only when necessary, complementing national capabilities. Upon receiving a request for

assistance, the Commission’s European Response Coordination Centre (ERCC) assesses

whether existing capacities offered by Member States are sufficient to ensure an effective

response to that request. Where an effective response cannot be ensured, the Commission

through the ERCC decides on the deployment of rescEU capacities

in accordance with the

Commission Implementing Decision 2025/704 of 10 April 2025 laying down rules for the implementation of Decision N°1213/2013/EU of

the European Parliament and of the Council on the Union Civil Protection Mechanism

In accordance with the procedure laid down in Article 12(6) of Decision No 1313/2013/EU

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criteria laid down in Commission Implementing Decision (EU) 2025/704, such as the

operational situation across Member States and potential disaster risks, as well as additional

criteria in the event of conflicting requests for assistance, such as

allocation keys based on

different scenarios.

Based on the lessons from previous deployments, the Commission will

analyse the pertinence of the current deployment criteria.

To support the deployment of medical countermeasures stocks, it is essential to ensure a

resilient distribution scheme with

expedited logistics providers

through multimodal

distribution capabilities (road, air, sea, and rail), including temperature control. This includes

overseas regions and the EU’s outermost regions. Several options exist for the optimal

deployment of stocks such as the rescEU or reliefEU capacities, or through agreement with

the company supplying the medical countermeasures. It also requires the development of

deployment, distribution, and dispensing plans at national level. The plans should be

developed, exercised and reviewed, to ensure their effectiveness during serious cross-border

outbreaks or high-impact events.

The deployment of medical countermeasures across Europe is subject to

several regulatory

requirements

aimed at ensuring safety, efficacy, and quality. Navigating these regulatory

requirements necessitates careful planning and coordination among manufacturers, regulatory

bodies, and health authorities to ensure the timely and efficient deployment of medical

countermeasures while adhering to legal requirements. In addition, the donation of the EU

stockpiles to beneficiary countries involves additional challenges such as regulatory

compliance, customs regulations, liability issues, traceability, etc. which have to be agreed

between the stakeholders to ensure regulatory compliance and effectiveness of the donations.

To address these challenges, in 2025 the Commission will build on existing tools and

resources, such as template contracts outlining considerations for donations. These challenges

also apply for the donations of national stockpiles, therefore the Commission played a strong

coordination role in the donation of mpox vaccines, to support the EU’s solidarity in times of

global health threats. The lessons learned from this valuable experience will be included in the

tools.

The Commission will also continue to support Member States to integrate medical

countermeasures deployment into comprehensive emergency response trainings.

The Commission together with Member States will build on existing

deployment tools

the second half of 2026, including on the experience from the mpox donations.

4.2.

EU minimum buffer

The Union Civil Protection Mechanism has a broad reach, and covers the 27 EU Member

States, and ten participating states (Albania, Bosnia and Herzegovina, Iceland, Moldova,

Montenegro, North-Macedonia, Norway, Serbia, Türkiye, and Ukraine). The rescEU stocks

can be requested in times of crisis, including for humanitarian aid reasons, which may mean

stocks are deployed beyond these countries.

Medical countermeasures are often much

more costly than non-medical goods

and the lead-

time for restocking a medical product can be much longer than for a non-medical product.

This makes

replenishment

of medical countermeasures under rescEU more challenging, and

the problem is exacerbated by the limitations of the current funding streams for

replenishment. Having medical countermeasures available for deployment at any time, is only

feasible when there is stock maintained in the warehouses to use for pandemic preparedness

and response as well as CBRN threats within the EU. The

possibility of replenishment

after

deployment will be explored in the preparation for the next multi-annual financial framework.

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To be able to find a balance between the optimal use of EU stockpiles and the level of EU

preparedness, safety margins are envisaged to be established in the form of an

EU minimum

buffer under future procurements.

This buffer is envisaged to ensure that a part of the

stockpiles remains available at EU level in case of an emergency. The optimal use of EU

stockpiles in this context cannot be seen in isolation from national stockpiles, their availability

and use and is dependent on strengthened secured information exchange and transparency on

national stocks, including in real-time.

The Commission will explore possible options to always maintain sufficient stocks at EU

level and establish safety margins.