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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)
EU4Health programme 2021-2027
Estimated EU contribution per project
Link to the call
Link to the submission
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.
This action aims to bring together sector professionals, for BM (topic (a)) and for FMT (topic (b)), 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 SoHO-based therapies.
Expected effects and impacts
The two topics should provide up-to-date guidelines on:
a) technical safety and quality aspects for BM (topic (a)) and for FMT (topic (b));
b) implementation of the legal requirements by establishments preparing these substances covered by both subtopics and applying therapies based on them.
They will also create a forum where key experts including Member States authorities can be engaged also in the future whenever the guidelines need to be updated, or when further advice is needed on their implementation.
Both subtopics will support the implementation of the new Union legislative framework on SoHO for entities preparing BM or FMT.
The result of the topic on faecal microbiota will consider the coherence with pharmaceutical actors/legislation, so that actors from both sectors (SoHO and Pharmaceuticals) can look into technical rules for faecal microbiota collected under SOHO and later to be used for manufacturing of pharmaceuticals.
The result of the subtopic on breast milk will consider the coherence with food actors/legislation, so that actors from both sectors (SoHO and food) can look into technical rules for breast milk collected under SOHO and later to be used for the manufacturing of food products.
The activities for both topics (a) and (b) are:
1) building an expert forum on breast milk and an expert forum on faecal microbiota transplants;
2) 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);
3) possible future updating of the guidelines, taking account of the new EU legislative framework;
4) 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
5) 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)
Regions / countries for funding
Moldova (Moldova), Island (Ísland), Norway (Norge), Ukraine (Україна)
International organization, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO)
Applications may be either by a single applicant or a consortium (no minimum requirement).
Applicants should be civil society organisations (professional associations, foundations, NGOs and similar entities) with expertise in the field of gastroenterology.
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.
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 mandatory deliverables and/or milestones
The mandatory deliverables are the same for both topics a and b
- Set-up of an expert forum including mandate, rules of procedure and proposed membership.
- Set of draft guidelines for entities/ establishments to implement technical standards, agreed amongst professionals and authorities where possible, and indicating points with divergent views
- Set of draft guidelines for entities/ establishments 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)
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)
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.
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)