Pilot actions for follow-on funding: Leveraging EU-funded collaborative research in regenerative medicine

Yes, this is a Lump Sum topic, as stipulated in the specific conditions of the topic. To define and justify the Lump Sum, you need to provide a detailed budget table with cost estimations (downloadable as an Excel file form the online submission system). The estimations must be an approximation of your actual costs and meet the eligibility criteria of Horizon Europe.

In order to facilitate the evaluation of your proposal, you are encouraged to use the comments part of the detailed budget table and provide any details / explanations that are needed to better understand the specificities of your proposal. You are also advised to systematically justify any deviations in personnel costs.

Moreover, if your lump sum budget contains any cost items in cost category C and/or D, please make sure to justify these items in the comments part of the detailed budget table, as the proposal template has been simplified by removing this information from Part B and bringing it closer to the relevant budget items. Specifically, you must include justifications in the comments part of the detailed budget table if you are in any of the following situations:

• If the sum of the costs for ’travel and subsistence’, ‘equipment’, and ‘other goods, works and services’ (i.e. the purchase costs) exceeds 15% of the personnel costs for a participant. If this is the case, justify the most expensive cost item(s) up to the level that the remaining costs are below 15% of personnel costs.
• If other cost categories (e.g. internally invoiced goods and services) are used.
• If in-kind contributions are used (non-financial resources made available free of charge by third parties, which must be included as direct costs in the corresponding cost category, e.g. personnel costs or purchase costs for equipment).

Please note that the definition of clinical studies, together with additional useful information can be found in the introduction of Health Cluster Work Programme part for 2026-2027.

Additionally, we would like to bring to your attention the fact that the World Health Organization (WHO) has published a “Guidance for best practices for clinical trials”. You are not required not follow this guidance, however we encourage you to do so.

Finally, we would also like to encourage you to consider the latest innovations and advances in the clinical trial design and research methods in order to evaluate promising interventions allowing shorter development timings.

The Health Cluster Work Programme part for 2026-2027 includes a “right to object” condition for nearly all topics, giving the granting authority the right to object to a transfer of ownership or to the exclusive licensing of results, up to 4 years after the end of the action.

For applicants and beneficiaries, little is expected to change, as in previous years this condition had been part of the General Annexes, having legal force across all parts of Horizon Europe (including the Health Cluster topics). In practise, the granting authority may invoke the “right to object” under specific conditions, which so far has happened in very rare occasions over the many years of Horizon Europe.

More details below from Annex 5 of the General Model Grant Agreement:

Where the call conditions in Horizon Europe actions provide for the right to object to transfers or licensing, the granting authority may — up to four years after the end of the action — object to a transfer of ownership or the exclusive licensing of results, if:

the beneficiaries which generated the results have received funding under the grant

it is to a legal entity established in a non-EU country not associated with Horizon Europe, and

the granting authority considers that the transfer or licence is not in line with EU interests.

Beneficiaries that intend to transfer ownership or grant an exclusive licence must formally notify the granting authority before the intended transfer or licensing takes place and:

identify the specific results concerned

describe in detail the new owner or licensee and the planned or potential exploitation of the results, and

include a reasoned assessment of the likely impact of the transfer or licence on EU interests, in particular regarding competitiveness as well as consistency with ethical principles and security considerations.

The granting authority may request additional information.

If the granting authority decides to object to a transfer or exclusive licence, it must formally notify the beneficiary concerned within 60 days of receiving notification (or any additional information it has requested).

No transfer or licensing may take place in the following cases:

pending the granting authority decision, within the period set out above

if the granting authority objects

until the conditions are complied with, if the granting authority objection comes with conditions.

A beneficiary may formally notify a request to waive the right to object regarding intended transfers or grants to a specifically identified third party, if measures safeguarding EU interests are in place. If the granting authority agrees, it will formally notify the beneficiary concerned within 60 days of receiving notification (or any additional information requested).

Yes, the ownership control declaration document is a mandatory annex to the proposal, in principle for all entities participating in the proposal in any capacity (as beneficiary, affiliated entity, associated partner, third party giving in-kind contributions, subcontractor or recipient of financial support to d parties, if allowed). Entities that are already validated as public bodies by the Central Validation Service are exempted since they will automatically be considered as controlled by their country. This is only valid for entities with a formal validation in the Participant Register as ‘public body’. Self-declared public bodies not validated by the Central Services will have to fill in the declaration as well.

The coordinator must collect the declarations from all entities participating in the proposal, as mentioned above, with the exception of entities already validated as public bodies by the Central Validation Service, and upload them in a single document in the Submission System. The declarations must be filled in, signed and stamped. Please check the mandatory template, which is accessible in the Submission System.

For successful proposals, applicants will be requested to submit supporting documents.

For detailed explanations about the ownership control assessment procedure, see the Guidance on participation in EU calls with ownership and control restrictionsPDF.