Call for proposals for next-generation respiratory protection (HERA) - CP-g-24-11

Deadline: Sep 5, 2024  
- 79 days

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.

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.

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.

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.