Call for proposals: action grants on the safety and quality of new Substances of Human Origin (Breast milk, faecal microbiota transplants) (b) HS-g-23-50.02 Faecal microbiotic transplants (HS-g-23-50.02)
Programme Category
Programme Name
Programme Description
The Programme aims to improve and promote health in the Union to reduce the burden of communicable and non-communicable diseases by:
- protecting people from serious cross-border health threats
- improving the availability, accessibility and affordability of medicines, medical devices and other crisis-related products in the EU
- strengthening national health systems
Identifier Code
Call
Summary
This action aims to bring together sector professionals, for Faecal Microbiota Transplants (FMT), and to facilitate the implementation of new SoHO Regulation (guidelines and legislative requirements as well as the compliance with oversight tasks), in order to allow the safe, effective and qualitative preparation and use of these substances of human origin (SoHO)-based therapies.
Detailed Call Description
This action implements the EU4Health Programme’s general objective of improving the availability, accessibility and affordability of medicinal products and medical devices, and crisis-relevant products in the Union, and supporting innovation regarding such products (Article 3, point (c) of Regulation (EU) 2021/522) through the specific objectives defined in Article 4, points (c) and (h), of Regulation (EU) 2021/522.
This action is part of the “Health Systems and Healthcare Workforce” strand, and it will contribute to “strengthening the implementation of the legislation on blood, tissues and cells and organs”. More specifically, this action will support harmonisation across national competent authorities in the field of organs.
The activities that can be funded are:
• building an expert forum on faecal microbiota transplants;
• developing, for each SoHO-based therapy, a common set of draft guidelines on the basis of the expert forum and existing initiatives (e.g. professional societies’ work, work in research actions);
• possible future updating of the guidelines, taking account of the new EU legislative framework;
• providing an implementation plan for establishments/entities in order to implement SoHO requirements, which will also consider the compliance with technical guidelines as well as with oversight provisions (entity and establishment authorisations, preparation process authorisations, inspections, vigilance and traceability); and
• training and dissemination programme. These activities are to be developed taking account the commonalities and specificities of SoHO-based therapies, i.e. FMT.
The mandatory deliverables are:
• Set-up of an expert forum including mandate, rules of procedure and proposed membership.
• Set of draft guidelines for entities to implement technical standards, agreed amongst professionals and authorities where possible, and indicating points with divergent views.
• Set of draft guidelines for entities to comply with oversight requirements, agreed amongst professionals and authorities where possible, and indicating points with divergent views.
• A proposed approach for future updating of guidelines.
• Gap analyses, recommended actions and implementation plan for entities to implement guidelines on technical standards and on oversight.
• Agreed training programme including necessary tools (manuals, surveys).
Call Total Budget
Financing percentage by EU or other bodies / Level of Subsidy or Loan
Maximum grant amount: is expected to be around €400.000 per project.
The costs will be reimbursed at the funding rate fixed in the Grant Agreement (60%). Your organisation can apply for a higher project funding rate (maximum 80%) if your project is of “exceptional utility”. Actions shall be considered to have exceptional utility where at least 30% of the budget of the proposed action is allocated to Member States whose GNI per inhabitant is less than 90% of the Union average; or the project concerns 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.
Thematic Categories
- Health
Eligibility for Participation
- Associations
- International Organisations
- Legal Entities
- NGOs
- Other Beneficiaries
- Private Bodies
- Researchers/Research Centers/Institutions
- State-owned Enterprises
Eligibility For Participation Notes
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 (list of participating countries)
Other eligibility conditions – Type of applicants targeted: Civil society organisations (professional associations, foundations, NGOs and similar entities) with expertise in the field of gastroenterology.
Consortium composition:
Applications may be either by a single applicant or a consortium (no minimum requirement).
Call Opening Date
Call Closing Date
National Contact Point(s)
Ministry of Health, Department of European Affairs
Ms MAKRIGIORGI Elena
Email: emakrigiorgi@moh.gov.cy
EU Contact Point
For help related to this call, please contact: HaDEA-HP-CALLS@ec.europa.eu