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Deadline expired

The deadline for this call has expired.

Call key data

Mapping the hurdles for the clinical applications of Advanced Therapy Medicinal Products (ATMPs)

Call number

HORIZON-HLTH-2023-IND-06-05

deadlines

Opening
12.01.2023

Deadline
13.04.2023 17:00

Deadline - 2nd stage

Opening
31.01.2023

Funding rate

100%

Call budget

€ 3,000,000.00

Estimated EU contribution per project

€ 3,000,000.00

Link to the call

ec.europa.eu

Link to the submission

ec.europa.eu

Call content

Call objectives

New pioneering treatments called Advanced Therapy Medicinal Products (ATMPs), including cell and gene therapies, have the potential to bring new cures to patients affected by diseases with limited or no available treatments. However, several hurdles impede or slow down the access of ATMPs to patients in the EU and Associated Countries. These include e.g. regulatory challenges, underlying scientific uncertainties, differences in assessing the values of ATMPs by the various Health Technology Agencies (HTA), difficulties to perform randomised-controlled clinical trials or to obtain long-term safety and effectiveness data, the lack of harmonised approaches to the reimbursement of the high upfront costs by health systems, manufacturing processes, etc.

The proposals should address all of the following activities:

  • Map the regulatory, safety and efficacy assessment, manufacturing, organisational and infrastructural needs to improve the translation of ATMPs from preclinical development to clinical use.
  • Address the gaps and uncertainties in regulatory and policy aspects pertinent to complex innovative ATMPs.
  • Address predictivity of preclinical data for safety and efficacy testing of ATMPs. Improved novel models could be proposed.
  • Tackle decision-making processes relating to ATMPs, such as for instance the assessment of their values, the demonstration of the long-term safety and effectiveness, or new pricing and reimbursement frameworks.
  • Propose opportunities for an improved knowledge of the regulatory processes among academic ATMP developers.
  • Involve regulatory authorities, Health Technology Agencies (HTA), clinicians, ethics committees, and patients, with the aim to ensure higher clinical use of ATMPs. The findings of the project will be available to competent authorities, ATMP developers and manufacturers as well as to national/regional funding agencies.

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Expected effects and impacts

Expected results

  • Challenging aspects of regulation, policy, safety, efficacy, manufacturing, organisation, infrastructure, decision-making, and commercialisation are identified for speeding up the equitable clinical applications of ATMPs.
  • European regulatory frameworks are adapted to novel scientific progress, especially those related to platform approaches, genome editing, interface with medical devices, artificial intelligence.
  • Competent authorities in the Member States can propose adapted pricing and reimbursement schemes that allow European citizens to benefit from novel ATMPs.
  • Academic and SME developers and manufacturers of ATMPs have an increased knowledge of the regulatory aspects.
  • The decentralised manufacturing of ATMPs is consistent across health care centres.

Eligibility Criteria

Regions / countries for funding

EU Member States, Overseas Countries and Territories (OCT)
Moldova (Moldova), Albania (Shqipëria), Armenia (Հայաստան), Bosnia and Herzegovina (Bosna i Hercegovina / Босна и Херцеговина), Faeroes (Føroyar / Færøerne), Georgia (საქართველო), Iceland (Ísland), Israel (ישראל / إِسْرَائِيل), Kosovo (Kosova/Kosovë / Косово), Montenegro (Црна Гора), Morocco (المغرب), North Macedonia (Северна Македонија), Norway (Norge), Serbia (Srbija/Сpбија), Tunisia (تونس /Tūnis), Türkiye, Ukraine (Україна), United Kingdom

eligible entities

EU Body, Education and training institution, International organization, Natural Person, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Private institution, incl. private company (private for profit), Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)

Mandatory partnership

No

Project Partnership

To be eligible for funding, applicants must be established in one of the following countries:

  • the Member States of the European Union, including their outermost regions
  • the Overseas Countries and Territories (OCTs) linked to the Member States
  • third countries associated to Horizon Europe - see list of particpating countries

Applications may be submitted by one or more legal entities, which may be established in a Member State, Associated Country or, in exceptional cases and if provided for in the specific call conditions, in another third country.

In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, legal entities established in the United States of America may exceptionally participate as a beneficiary or affiliated entity, and are eligible to receive Union funding. 

Coordinators of projects must be legal entities established in an EU Member State or Associated Country.

Any legal entity, regardless of its place of establishment, including legal entities from non-associated third countries or international organisations (including international European research organisations) is eligible to participate (whether it is eligible for funding or not), provided that the conditions laid down in the Horizon Europe Regulation have been met, along with any other conditions laid down in the specific call topic.

A ‘legal entity’ means any natural or legal person created and recognised as such under national law, EU law or international law, which has legal personality and which may, acting in its own name, exercise rights and be subject to obligations, or an entity without legal personality.

Specific cases:

  • Affiliated entities — Affiliated entities (i.e. entities with a legal or capital link to a beneficiary which participate in the action with similar rights and obligations to the beneficiaries, but which do not sign the grant agreement and therefore do not become beneficiaries themselves) are allowed, if they are eligible for participation and funding.
  • Associated partners — Associated partners (i.e. entities which participate in the action without signing the grant agreement, and without the right to charge costs or claim contributions) are allowed, subject to any conditions regarding associated partners set out in the specific call conditions.
  • 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 to protect the EU’s financial interests equivalent to those offered by legal persons.
  • EU bodies — Legal entities created under EU law including decentralised agencies may be part of the consortium, unless provided for otherwise in their basic act.
  • Joint Research Centre (‘JRC’)— Where provided for in the specific call conditions, applicants may include in their proposals the possible contribution of the JRC but the JRC will not participate in the preparation and submission of the proposal. Applicants will indicate the contribution that the JRC could bring to the project based on the scope of the topic text. After the evaluation process, the JRC and the consortium selected for funding may come to an agreement on the specific terms of the participation of the JRC. If an agreement is found, the JRC may accede to the grant agreement as beneficiary requesting zero funding or participate as an associated partner, and would accede to the consortium as a member.
  • Associations and interest groupings — Entities composed of members (e.g. European research infrastructure consortia (ERICs)) may participate as ‘sole beneficiaries’ or ‘beneficiaries without legal personality’. However, if the action is in practice implemented by the individual members, those members should also participate (either as beneficiaries or as affiliated entities, otherwise their costs will NOT be eligible.

Additional information

Topics

Digitalisation, Digital Society, ICT, 
Health, Social Services, Sports

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)

Additional Information

All proposals must be submitted electronically via the Funders & Tenders Portal electronic submission system (accessible via the topic page in the Search Funding & Tenders section). Paper submissions are NOT possible.

Proposals must be complete and contain all parts and mandatory annexes and supporting documents, e.g. plan for the exploitation and dissemination of the results including communication activities, etc.

The application form will have two parts:

  • Part A (to be filled in directly online) contains administrative information about the applicant organisations (future coordinator and beneficiaries and affiliated entities), the summarised budget for the proposal and call-specific questions;
  • Part B (to be downloaded from the Portal submission system, completed and then assembled and re-uploaded as a PDF in the system) contains the technical description of the project.

Annexes and supporting documents will be directly available in the submission system and must be uploaded as PDF files (or other formats allowed by the system).

The limit for a full application (Part B) is 30  pages.

The award criteria are described in General Annex D. The following exceptions apply: The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.

Call documents

HE-Work Programme 2023-2024, Cluster 1, Destination 6HE-Work Programme 2023-2024, Cluster 1, Destination 6(452kB)

Contact

National Contact Points for Horizon Europe
Website

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