Call for proposals: action grants on the safety and quality of new Substances of Human Origin (Breast milk, faecal microbiota transplants) (a) HS-g-23-50.01 Breast milk (HS-g-23-50.01) / (b) HS-g-23-50.02 Faecal microbiotic transplants (HS-g-23-50.02)
Summary
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
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
Call
Detailed Call Description
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 for both topics (a) and (b) are:
- building an expert forum on breast milk and an expert forum on faecal microbiota transplants;
- developing, for each SoHO-based therapy, a common set of draft guidelines, with this expert forum, and based on 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 both SoHO-based therapies, i.e. BM and FMT (respectively in topic a and b).
Financing percentage by EU or other bodies / Level of Subsidy or Loan
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 (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 4 are from Member States whose GNI per inhabitant is less than 90% of the EU average.
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 (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 4 are from Member States whose GNI per inhabitant is less than 90% of the EU average.
Eligibility For Participation Notes
Applications will only be considered eligible if their content corresponds wholly (or at least in part) to the topic description for which it is submitted.
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)
Type of applicants targeted: Topic a: Civil society organisations (professional associations, foundations, NGOs and similar entities) with expertise in the field of neonatology Topic b: Civil society organisations (professional associations, foundations, NGOs and similar entities) with expertise in the field of gastroenterology.
Specific eligibility criteria applicable to the consortium composition: Applications may be either by a single applicant or a consortium (no minimum requirement)
Applicants will include the following specific action-level indicators and related reporting activities in their proposals:
- Numbers of entities/establishments involved
- Number of BM/FMT prepared by these entities/establishments
- Numbers of guidelines developed and agreed with professionals and SoHO authorities
Programme Category
EU Competitive ProgrammesTotal Budget
€400 000Thematic Categories
- Health
- Public Administration
Eligibility for Participation
- Associations
- International Organisations
- NGOs
- Non Profit Organisations
- Other Beneficiaries
Call Opening Date
15/06/2023Call Closing Date
17/10/2023National Contact Point(s)
Ministry of Health, Department of European Affairs
Ms MAKRIGIORGI Elena
emakrigiorgi@moh.gov.cy
EU Contact Point
Stefan DE KEERSMAECKER
+32 2 298 46 80
stefan.de-keersmaecker@ec.europa.eu
Darragh CASSIDY
+32 2 298 39 78