European defence medical countermeasures alliance

Topic description

Objective:

The framework partnership will support individual troop readiness and total force health protection by developing technologies and products to rapidly identify and respond to biological threats (including natural and genetically modified organism), chemical hazards and attacks, toxins as well as countermeasures regarding radio-nuclear and nuclear threats. Funded actions also focus on the research and development of vaccines and drugs and other antibiological substances (e.g., bacteriophages) against biological agents that may affect a sizable number of the military and/or be used on the battlefield. A subset of the funded actions specifically supports solutions to be used by personnel with minimal medical training, deployable laboratory capabilities even in the low-resource environments typical of many military operations.

The objective of proposals under this call is to update and/or develop medical countermeasures (MCMs) for the armed forces of EU and – wherever applicable - related civil/health protection to respond to the continuously changing and novel health threats posed by CBRN. It thus aims at developing shared capabilities for EU armed forces against CBRN crises, and to treat exposure, pathologies or injuries of significant impact.

This framework partnership will contribute to responding more efficiently to conflicts, crises, or isolated events involving CBRN situations.

Scope

To master the evolving threats, the Commission intends to establish a stable and structured partnership with legal entities grouped in a consortium which commit themselves to:

• Create a long-term open, supportive and sustainable cooperation mechanism in Europe amplifying, connecting and strengthening EU (defence) medical research and development capabilities on selected medical threats; and,
• Contribute to the accessibility and availability of medical countermeasures and strengthen their disposability.

Framework partners should focus on innovation, research and development of medical countermeasures against CBRN threats as well as their integration into EU and Member States and Norway health sector, civil protection mechanism and military forces.

Partners may also provide for analysis of the relevance and feasibility of novel MCMs and related technology, further and/or continuous mapping of CBRN MCM capacities across EU, as well as options for ensuring EU’s access and availability of MCMs.

MCMs may include clinical testing capabilities or methods, any medicines or medical devices that are aimed at combating CBRN threats. This extends both to countermeasures that prevent or treat the threat. For MCMs to be updated, available and able to respond, this entails a large scope covering innovation, research, development and analysis.

Types of activities that can be funded

This partnership will be set up through an FPA, which will enable the completion of a multiannual action plan within the context of the agreement.

Applicants are invited to:

• propose a multiannual action plan providing clear descriptions of the main activities and implementation methodology;
• describe the contribution and added value of the partnership to the EU policy in the area of this call;
• describe the way in which they use monitoring and/or external evaluations in order to assess their overall performance and the relevance and impact of their outputs.

The consortia responding to the call may include military medical commands, research institutes, universities, RTOs, industry, SMEs as well as other organisations that can play a role in the realisation of defence medical countermeasures. The FPA will specify the objectives, the nature of the actions planned, and the procedure for awarding specific grants.

The FPA is expected to contribute to the following outcomes:

• Establish a technology innovation roadmap (multiannual action plan) for linking early-stage capabilities to industry developments.
• Focus on research, innovation and development of defence medical countermeasures against CBRN threats as well as their integration into Member States and Norway military forces, EU health sector and civil protection mechanisms.
• Establish a well-connected network at European level in order to facilitate interoperability in detecting and validating CBRN threats and enlarge capabilities by a consequent cooperation and subsequent division of labour and capacities.
• Stimulate cooperation between European military and civilian research institutes and industry to initiate a core of European research base on military health issues.

Specific grants implemented under the FPA must be in line with the proposed Action Plan and may cover one or more of the activities as referred in article 10(3) of the EDF Regulation.

• Generating knowledge: choice of pharmacological target, antigen, or physiological process; target or antibody validation; elucidation of mechanism of action.
• Integrating knowledge: development of industrial production under GMP conditions; demonstration of the stability of MCMs (GMP) in bulk and distributed form (ICH Stability testing of new drug substances and drug products).
• Studies: In vitro assays, in aerosol particles, in vivo proof of concept studies.
• Design: Preclinical trials (DRS, safety, efficacy) on relevant animal models, quality control tests, validation of industrial production process under GMP conditions. Pivotal efficacy studies on animal models as close as possible to humans (authorization under exceptional circumstances).
• Testing: phase I clinical trial with most advanced MCM candidates.
• Qualification: finalization of a dossier for marketing authorization.
• Certification: New drug application (NDA) delivered by the regulatory authority (EMA) or early access program.

Innovative disruptive technologies, like MCMs that limit the development of resistance (e.g., broad-spectrum or highly specific and individualized MCMs), and platforms for local production of MCMs on-demand, may also be covered.

Functional requirements

Proposals for the FPA must provide for an Action Plan that should cover, but should not limit to, the following areas:

(1) Broad scientific approaches to address general needs

• Research on the properties of and protection from new and emerging CBRN threats
• Developing new technologies for the rapid manufacturing, delivery and distribution of large size medical countermeasures.

(2) Targeted R&D activities that address specific needs

• Development of new generation auto-injectors for antidotes administration.
• Development of technologies, solutions and deployable platforms that integrate, automate, and miniaturize the collection, processing, and analysis of biological and chemical samples.
• Development of novel technologies or measures to treat infections and wounds contaminated by CBR-agents (e.g., sorbent separation mechanism).
• Development on novel Medical Countermeasures against CBRN threats.

(3) High-risk activities with potential pivotal outcomes

• Innovative disruptive methods: Applications or technologies that enables EU to develop novel capabilities such as on demand production of civilian and military-critical materiel and medical countermeasures.
• Development of a mobile, scalable and adaptable European platform for rapid development of medical countermeasures capable of producing relevant numbers of doses against any known or previously unknown CBRN threat within 60 days of identification.
• Development of novel methods to impart near-immediate immunity to an individual using antibodies or generating specific immunity on routes of entry for infection, such as mouth and nose for airborne agents.
• Generation of technologies and scientific knowledge of human physiological responses caused by exposure to any biological or chemical agent.
• Development of new technologies for the simulation of human body response to medical countermeasures against emerging infectious diseases and chemical or biological attacks.

Proposals for FPAs should expand and strengthen the supply chain, aiming for the development of key enabling technologies while improving notions of control of medical countermeasures.

Proposals for FPAs should also develop an IP strategy to protect innovations in the field of medical countermeasures and to provide information about the IPRs that are open to licensing.

Proposals for FPAs should also cover: (i) the collaboration with other initiatives or programmes at regional, national, EU or NATO level and (ii) any additional support they may receive in their activities from relevant national, or regional programmes and initiatives. They should also contribute to spreading excellence across Europe.

The Commission expects the partnership to design and implement relevant, quality and impactful activities that fit the objectives and priorities defined in the call. The action plan should clearly demonstrate the organisation's capacity to generate concrete impacts.

Applicants are invited to:

• provide clear descriptions of the main activities and implementation methodology;
• describe the contribution and added value of the partnership to the EU policy in the area of this call;
• describe the way in which they use monitoring and external evaluations in order to assess their overall performance and the relevance and impact of their outputs.

In terms of results, the Commission expects the framework partnership to:

• Provide substantial improvements to the CBRN defence domain for Member States and Norway armed forces with consistent CBRN medical protections against a large panel of threats currently not covered by drugs produced within EU;
• Facilitate the development of CBRN defence capabilities that each Member State and associated country, individual government or industry cannot face alone (i.e., a technological platform for the production of medical countermeasures);
• Stimulate cooperation between European military and civilian research institutes and industry to initiate a core of European research base on military health issues,
• Carry out and support coherent projects over the long term and prepare their integration in a global solution (system of systems),
• Strengthen European sovereignty and contribute to the EU strategic autonomy,
• Develop EU autonomous industrial segments.

Even if the main objective of the project is to contribute to the armed forces, its results can also be of interest for the civilian sector.

[1]‘System prototype’ means a model of a product or technology that can demonstrate performance in an operational environment.

[2]‘Qualification’ means the entire process of demonstrating that the design of the product, component or technology meets the specified requirements, providing objective evidence by which particular requirements of a design are demonstrated to have been met.

[3]‘Certification’ means the process by which a national authority certifies that the product, component or technology complies with the applicable regulations.