In June 2026, four new calls for tenders were launched by HERA (Health Emergency Preparedness and Response Authority) in close collaboration with HaDEA (Health and Digital Executive Agency), with the deadline for submitting letters of intent set for 2 September 2026.
All of these form part of the European Union’s strategy to improve the EU’s preparedness for health emergencies. This is notably the aim of the EU4Health programme, which, in the wake of the COVID-19 crisis, is addressing the resilience of European healthcare systems and is now enabling these four calls for proposals to be launched. One of the main objectives is to improve the availability and accessibility – both in terms of affordability and supply – of medicines, medical devices and crisis-related products.
1- Framework contracts to accelerate the development of and access to innovative medical countermeasures – Next-Generation Therapeutics for Infectious Diseases
The first call for proposals, which closes on 2 September, has been launched to accelerate the development of next-generation therapies for infectious diseases. This is a multi-supply framework contract designed to speed up the development of and access to innovative medical countermeasures. A distinctive feature of this call is the “pre-commercial procurement” (PCP) approach (a phased, competitive development approach), whereby candidates compete against one another across several stages.
The project will therefore be carried out in phases on a competitive basis, with several contractors competing against one another, the number of which will be progressively reduced at each phase, with an expected outcome of five framework contracts in total (three for Lot 1 and two for Lot 2). During the first phase, the first specific contract will be awarded directly based on the ranking of the initial tender. Subsequently, the following phases will be subject to a reopening of the competitive tendering process, restricted solely to contractors who have successfully completed the previous phase.
The scope of the call is expected to cover the development of innovative therapies to treat viral infections, acute respiratory distress syndrome (ARDS) or sepsis resulting from infections. The idea behind this approach is not to purchase a product but to procure research and development services based on a phased competitive selection of solutions across different stages of development, with risks and benefits shared between the parties on market terms, and with the aim of stimulating innovation, economic growth and job creation.
The procedure for this call for tenders is a two-stage competitive process. The first stage involves assessing applications to participate, and in the second stage, the shortlisted candidates submit a full tender.
The call for proposals is divided into two categories. The first category covers highly innovative therapies and the second category covers advanced therapies.
– The first batch is divided into three phases and requires a technology readiness level of 3 at the time of application. This first batch focuses on treatments targeting pathogens and evolving pathogens, innovative combination therapies, and treatments designed to be administered via routes other than intravenous injection. It therefore covers RNA technologies, innovative peptides, proteins and innovative immunoglobulins. It explicitly excludes small molecules and monoclonal antibodies.
– The second batch is divided into two phases and requires a Technology Readiness Level (TRL) of 6 at the time of application. Lot 2 focuses on adaptable targeted therapies, innovative combination therapies and treatments designed to be administered via routes other than intravenous injection. It targets the host using the same technologies as Lot 1, plus small molecules and monoclonal antibodies.
Both lots share the common objective of reaching a TRL of 8 by the end of the final phase.
Lot 1 comprises three phases, whilst Lot 2 consists solely of phases 2 and 3. The first phase is a “Solution Optimisation” phase, lasting 36 months and covering the advanced pre-clinical stage through to the end of Phase I clinical trials. The second phase is an “Advanced Development” phase; it lasts 30 months and extends to the end of Phase II clinical trials. The final phase, “Pre-market Development”, lasts 36 months and covers Phase III clinical trials, as well as the preparation and submission of the marketing authorisation application.
The total estimated budget is €100 million for Lot 1 and €92 million for Lot 2, with each framework contract capped at approximately €138 million and €114 million respectively.
Applicants must meet three selection criteria relating to their technical and professional capabilities. They must have carried out at least one R&D project in the field of infectious disease therapies (or sepsis/ARDS) within the last 10 years, at least one project demonstrating the management of a drug’s scientific life cycle (quality, clinical and non-clinical activities) within the last 10 years, and a core team comprising a minimum number of members with specific profiles.
2- Preparing for filovirus outbreaks through the establishment of a pilot filovirus investigational vaccine reserve
This call for proposals, which closes on 2 September and has a budget of 16 million euros, aims to establish, manage and maintain a reserve of vaccine candidates targeting filoviruses that are pathogenic to humans, for which no authorised vaccine is currently available (Marburg virus (MARV), Sudan virus (SUDV) and Bundibugyo virus (BDBV)). In the event of an outbreak, the vaccines could be used to advance their development by incorporating them into clinical trials linked to the outbreak. These arrangements would enable the rapid deployment of candidate vaccines for further development at a later stage.
This appeal forms part of an effort to work in synergy with the global and European response to the recent Ebola outbreak in the Democratic Republic of the Congo, notably the WHO’s response and the initiatives launched by CEPI (the Coalition for Epidemic Preparedness Innovations)
At the same time, other calls for proposals have been launched by DG R&D, notably one relating to flaviviruses (HORIZON-HLTH-2027-01-DISEASE-06). This call aims to fund the pre-clinical and clinical development of innovative monoclonal antibodies against one of the priority flaviviruses, in order to strengthen the EU’s preparedness for future health crises.
The call is structured in three phases. The first phase, “Preparedness and Readiness Development”, aims to establish preparations for clinical trials and the production of the stockpile. The second phase, “Sustained Readiness and Capacity Maintenance”, will focus on maintaining the stockpile and operational capabilities. Finally, the third stage, «Outbreak Activation and Clinical Response», involves activating the mechanism and launching clinical response trials when an eligible outbreak is declared.
To be eligible, the product must meet all of the following criteria:
– to target Marburg and/or Sudan Ebola and/or Bundibugyo Ebola,
– be an investigational medicinal product (IMP) without marketing authorisation,
– be suitable for deployment in an epidemic context (including «ring vaccination»),
– have completed the necessary non-clinical assessments and
– have initiated or completed at least one Phase I clinical trial.
– have at least one project relating to the manufacture or management of IMPs in a clinical or emergency context, and at least one project relating to the logistics or deployment of medical countermeasures (cold chain, international transport).
3. EU FAB+ Multiple sourcing pilot for capacity reservation for personal protective equipment (PPE)
This call was launched in response to the European Union’s dependence on non-European producers for essential products in the event of a health crisis. It builds on the EU FAB scheme, which had already set aside manufacturing capacity for vaccines in the event of a health crisis. This time, the scheme has been extended to other medical countermeasures (MCMs), namely nitrile examination gloves and FFP2 respirator masks.
This call for proposals, which closes on 15 October and has an indicative budget of €34 million, aims to improve the accessibility and availability of medical countermeasures within the EU/EEA. Specifically, the aim of this call is to award contracts for the reservation of manufacturing capacity and stocks managed by the supplier of nitrile examination gloves (Lot 1) and FFP2 respiratory masks (Lot 2).
The contractor must have manufacturing capacity within the EU/EEA. It must also establish a «vendor-managed inventory» of the products in question. This stock will be subject to a priority purchase right, which the contracting authority may exercise in the event of a preparedness requirement or a crisis. Once a purchase has been made, the stock must either be replenished or offset by an equivalent reserve of manufacturing capacity for the remainder of the contract period.
Each lot will be awarded to a maximum of three tenderers for a period of three years per contract.
4. Long-term stockpiling of active pharmaceutical ingredients (APIs) and rapid production of finished dosage forms
In order to manufacture a medicine, two elements are required: an active ingredient – that is, the molecule that will act within the human body – and its pharmaceutical form, such as a capsule, a tablet or a syrup. HERA’s current strategy of stockpiling finished products has its limitations: as active ingredients have a limited shelf life (18 to 60 months), there is a risk of becoming reliant on perfectly accurate forecasts, as well as a risk of financial and environmental waste arising from products that are never used and reach their expiry date.
Storing APIs (active pharmaceutical ingredients) rather than the finished product would allow for a much longer shelf life and greater flexibility. However, the standard manufacturing lead time is usually 3 to 6 months, which would be too slow to respond to an emergency. The proposed solution would be to combine an optimised API storage system (temperature, humidity, inert gas) with continuous manufacturing, Process Analytical Technology (PAT) and Real-Time Release Testing (RTRT) to reduce this lead time to a matter of days.
That is why the European Union is today launching, with a budget of 6M euros, this call for proposals, which closes on 29 September, to fund a pilot feasibility project for the long-term storage of active pharmaceutical ingredients (APIs) combined with the rapid manufacture of finished pharmaceutical products, in response to health emergencies.
Applicants must have an average turnover of at least €3,000,000 over two years, at least one similar project in pharmaceutical manufacturing or new product development, facilities (analytical laboratory, R&D, manufacturing) available within the EU; and, finally, an experienced operational team (project manager (5 years’ experience), 2 process development specialists (3 years’ experience), a PAT/control strategy specialist (3 years’ experience), 2 analysts (5 years’ experience), and a regulatory/quality specialist (3 years’ experience)).
At the end of these 36 months, a comprehensive decision-making dossier is expected to be submitted to HERA and the Commission, combining scientific evidence, an economic analysis and operational recommendations, enabling them to decide whether and how this stockpiling model could subsequently be rolled out across Europe.
Authors: Camille Maisse and Landry Cochard
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