Funding programme

EU4Health is the EU’s funding programme to deliver on EU health policy and respond to the COVID-19 pandemic.

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Call overview

This call aims to enhance the safe, effective and qualitative preparation and use of SoHO-based therapies.

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Call detail

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.

• Topic a: Breast Milk
• Tobic b: Faecal microbiotic transplants

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Background

The 2019 evaluation of the Union legislation on blood, tissues and cells identified a legal gap in terms of Regulation for some therapies made from substances of human origin (SoHO) that cannot necessarily be defined as blood, tissues, cells or organs. It concerns in particular therapies like human Faecal Microbiota Transplants (FMT) and Breast Milk (BM), whose use entails the need to avoid transmission of diseases from donors, a key concern for all SoHO therapies. The revision of the Union legislative frameworks (blood and tissues and cells) aims to cover this gap and it plans to address safety and quality requirements for these therapies.

Read more in the call document

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Objectives

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.

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Activities that can be funded

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)

Read more in the call document

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Expected impact

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.

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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.

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Consortium composition

Applications may be either by a single applicant or a consortium (no minimum requirement)

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Eligibility

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)

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Funding available

Tpoic a: EUR 400.000

Topic b: EUR 400.000

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Duration

Expected duration of the project(s) in months: 18 months