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  1. An institution, body, office or agency established by or based on the Treaty on European Union and the Treaties establishing the European Communities.

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    A microenterprise, a small or medium-sized enterprise (business) as defined in EU Recommendation 2003/361. To qualify as an SME for EU funding, an enterprise must meet certain conditions, including (a) fewer than 250 employees and (b) an annual turnover not exceeding EUR 50 million and/or an annual balance sheet total not exceeding EUR 43 million. These ceilings apply only to the figures for individual companies.

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  1. Governance, partnership: Projects aimed at increasing the application of multilevel and transnational or cross-border governance, designing and testing appropriate governance structures and mechanisms. Also cooperation between public institutions on any theme.

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    Activities focussing on agricultural products, organic farming, horticulture, as well as forest management and wood products; furthermore the development of the food sector, food chains, organic food production, and seafood products and any topics related to animals and fishing.

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    Community integration and common identity projects that build identity, create a more cohesive society, promote positive relations through an increased provision of shared spaces and services.

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    This is about the mitigation and management of risks and disasters, and the anticipation and response capacity towards the actors regarding specific risks and management of natural disasters, for example, prevention of flood and drought hazards, forest fire, strong weather conditions, etc.. It is also about risk assessment and safety.

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Call key data

Call for proposals for next-generation respiratory protection (HERA)

Funding Program

EU4Health programme 2021-2027

Call number

EU4H-2024-PJ-01-2

deadlines

Opening
23.05.2024

Deadline
05.09.2024 17:00

Funding rate

60-80%

Call budget

€ 20,000,000.00

Estimated EU contribution per project

€ 5,000,000.00

Link to the call

Link to the submission

Call content

short description

Through this action, HERA will support the development of next-generation respiratory PPE that addresses and/or mitigates the above-mentioned issues (see section 1.2), ending a 30-year period of no significant innovation in the field and ultimately ensuring a more effective response to future cross-border health threats, with an all-threats approach. In this context, it implements the EU4Health general objective of improving the availability, accessibility and affordability of medicinal products and medical devices, and crisis-relevant products in the Union, and supports the innovation of such products (Article 3, point (c) of Regulation (EU) 2021/522) through the specific objectives defined in Article 4, points (b) and (c) of Regulation (EU) 2021/522.

Call objectives

Applicants might develop completely new technologies or rely on reformulated designs and novel applications of existing materials and technologies. Applicants need to propose a detailed plan to design, prototype, validate, and CE-mark innovative, cost-effective, and sustainable next-generation respirators. To overcome the limitations outlined above, they need to offer higher levels of protection than FFP2 respirators while being universally fitting, enabling comfortable multi-hour use.

Different solutions may target different populations (e.g., clinicians, critical workers, the public, etc.). Proposals should include a dissemination and market readiness plan that ensures a market for the product in preparedness times – e.g., through stockpiling or active use. This plan should generate sufficient demand to set up production.

Importantly, developers also need to demonstrate feasibility for a rapid production scale-up once a public health emergency materialises, possibly relying on distributed manufacturing solutions and use of accessible raw materials. Products should demonstrate the potential to be at a cost that will allow for a switch from the currently used PPE. To encourage sustainability, products should be reusable, less harmful to the environment and ideally foster environmentally friendly production. Proposals need to take into consideration that next generation respiratory devices should be easy to store (e.g., occupying minimum space in stockpiles and having long expiry dates) and simple to use by the target population.

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Expected effects and impacts

This action will support bringing next-generation PPE to the market to provide sustainable, universal and effective choices for the personal protection of healthcare and other essential workers, patients and the public. Superior respiratory protection will be available for stockpiling, scale-up and uptake by healthcare systems and the public in response to future pandemics or epidemics. The reduction of the use of single-use products will make the EU less vulnerable to supply chain disruptions.

Cost-effective and user-friendly next-generation respirators will slowly replace regular respirators and be deployed at national, regional, and local levels, ensuring better preparedness for future pandemics and other cross-border health threats. Widely incorporating improved respirators into clinical practice will also lead to better protection for healthcare workers and patients already in preparedness times, and overall improved health outcomes.

Expected results

The objective of this action is to foster innovation and support the development of next-generation respiratory PPE that overcomes the limitations outlined above and result in increased availability of enhanced medical countermeasures for pandemic preparedness and response.

Eligibility Criteria

Regions / countries for funding

EU Member States, Overseas Countries and Territories (OCT)
Moldova (Moldova), Iceland (Ísland), Montenegro (Црна Гора), Norway (Norge), Ukraine (Україна)

eligible entities

Education and training institution, International organization, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Private institution, incl. private company (private for profit), Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)

Mandatory partnership

No

Project Partnership

Proposals must be submitted by either a single applicant or a consortium of at least 3 applicants (beneficiaries; not affiliated entities), which complies with the following conditions:  Single applicants (or at least one of the members of a consortium) must have expertise (proven by relevant past projects) in at least one of the following areas: 

  • respiratory protective equipment
  • hospital management
  • medical device engineering
  • or stockpiling. 

Expertise needs to be clearly highlighted in the proposal.

In order to be eligible, the applicants (beneficiaries and affiliated entities) must:

  • be legal entities (public or private bodies)
  • be established in one of the eligible countries, i.e.:
    • EU Member States (including overseas countries and territories (OCTs
    • eligible non-EU countries: listed EEA countries and countries associated to the EU4Health Programme or countries which are in ongoing negotiations for an association agreement and where the agreement enters into force before grant signature (list of participating countries)

Other entities may participate in other consortium roles, such as associated partners, subcontractors, third parties giving in-kind contributions, etc.


Specific cases:

Natural persons — Natural persons are NOT eligible (with the exception of self-employed persons, i.e. sole traders, where the company does not have legal personality separate from that of the natural person).

International organisations — International organisations are eligible. The rules on eligible countries do not apply to them.

Entities without legal personality — Entities which do not have legal personality under their national law may exceptionally participate, provided that their representatives have the capacity to undertake legal obligations on their behalf, and offer guarantees for the protection of the EU financial interests equivalent to that offered by legal persons.

EU bodies — EU bodies (with the exception of the European Commission Joint Research Centre) can NOT be part of the consortium.

Associations and interest groupings — Entities composed of members may participate as ‘sole beneficiaries’ or ‘beneficiaries without legal personality’. Please note that if the action will be implemented by the members, they should also participate (either as beneficiaries or as affiliated entities, otherwise their costs will NOT be eligible).

European Reference Networks (ERNs) — These cover networks between healthcare providers and centres of expertise in the Member States to reinforce healthcare cooperation, in particular in the area of rare diseases, in line with the objectives set out in Article 12 of Directive 2011/24.

other eligibility criteria

Specific eligibility criteria: Legal entities active in the field of innovation and with adequate expertise in PPE, proven by  experience in the sector (e.g. past development activities, academic research). Hospitals, other employers of critical workers or stockpiling entities might be part of a consortium to ensure validation, testing and uptake of developed products.

Financial support to third parties is not allowed.

The costs will be reimbursed at the funding rate fixed in the Grant Agreement (60%). 

You can apply for a higher project funding rate (80%) if your project is of ‘exceptional utility’, i.e. concerns:

  • actions where at least 30 % of the budget is allocated to Member States whose GNI per inhabitant is less than 90% of the EU average or
  • actions with bodies from at least 14 Member States and where at least four are from Member States whose GNI per inhabitant is less than 90% of the EU average.

Additional information

Topics

Health, Social Services, Sports

Relevance for EU Macro-Region

EUSAIR - EU Strategy for the Adriatic and Ionian Region, EUSALP - EU Strategy for the Alpine Space, EUSBSR - EU Strategy for the Baltic Sea Region, EUSDR - EU Strategy for the Danube Region

UN Sustainable Development Goals (UN-SDGs)

project duration

48 months

Additional Information

Proposals must be submitted electronically via the Funding & Tenders Portal Electronic Submission System (accessible via the Topic page in the Search Funding & Tenders section). Paper submissions are NOT possible. Proposals (including annexes and supporting documents) must be submitted using the forms provided inside the Submission System.

Proposals must be complete and contain all the requested information and all required annexes and supporting documents:

  • Application Form Part A — contains administrative information about the participants (future coordinator, beneficiaries and affiliated entities) and the summarised budget for the project (to be filled in directly online)

  • Application Form Part B — contains the technical description of the project (to be downloaded from the Portal Submission System, completed and then assembled and re-uploaded)

  • mandatory annexes and supporting documents (templates available to be downloaded from the Portal Submission System, completed, assembled and re-uploaded):

    • detailed budget table/calculator

    • CVs (standard) of core project team

    • list of previous projects (key projects for the last 4 years) (template available in Part B)

Proposals are limited to maximum 70 pages (Part B). Evaluators will not consider any additional pages.

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