Innovative Health Initiative JU Call 12

Expected Impact:

Applicants are expected to define the expected impacts to be achieved by their proposal that will contribute to one or more of the expected impacts linked to IHI JU’s Specific Objective 1 as set out in the IHI JU SRIA, i.e.:

• patients benefit from preventive treatment or early disease intervention before onset of symptoms;
• prevention and early diagnosis of disease combined with better understanding of the mechanisms involved, leading to the development of more cost-effective strategies;
• patients benefit from improved healthcare through regular monitoring of critical parameters using validated tools;
• development of new vaccine strategies targeted to specific sub-populations;
• increased preparedness of EU healthcare systems for disease outbreaks.

Furthermore, the actions to be funded under this topic are expected to contribute to:

a) the strengthening of the competitiveness of the EU’s health industry, via increased economic activity in the development of health technologies, in particular integrated health solutions, thus fostering European technological leadership and the digital transformation of our societies.

b) the implementation of the EU’s Life Sciences Strategy¹ and its specific aims such as:

1. reinforcing European R&I e.g. through the translation of new knowledge to innovative health solutions;
2. promoting a holistic approach to the life sciences (e.g. One Health approach among others).

The actions are expected also to consider and contribute to EU programmes, initiatives and policies such as the European Green Deal, Europe’s Beating Cancer Plan, the EU Mission on Cancer, the Apply AI Strategy, the European Virtual Human Twins Initiative, the 1+ Million Genomes Initiative, the preparedness and response to health emergencies, the upcoming EU Biotech Act, the Regulation on the European Health Data Space (EHDS), and the EU Artificial Intelligence Act, where relevant.

¹ _{http://research-and-innovation.ec.europa.eu/document/download/411698e8-6062-41af-96e5-af54474d70f5_en}

Expected Outcome:

Applicants must define the outcomes expected to be achieved by their proposal, ensuring that they add novel contributions to a better understanding of the determinants of health and priority disease areas, in line with the IHI JU’s Specific Objective 1 as set out in the IHI JU Strategic Research and Innovation Agenda (SRIA).

Actions (projects) to be funded under this topic must deliver outcomes that address public health needs and support the development of future health innovations that are safe, people-centred, effective, cost-effective and affordable for patients and for health care systems. These outcomes are also expected to benefit the relevant stakeholders in the healthcare ecosystem.

The expected outcomes may cover the entire spectrum of care from prevention to disease management and may be centred around disease areas, key themes or approaches such as prevention, precision diagnostics, personalised medicine, and chronic disease management. They may also include enabling solutions for digitalisation, artificial intelligence (AI), regulatory science, greener and more sustainable healthcare and the deployment and use of these solutions into practice.

Scope:

With a view to harnessing new science and technologies, this topic aims to fund pre-competitive research and innovation for novel tools, methods and technologies that will foster the development of health innovations to prevent, intercept, diagnose, treat, and manage diseases and enable recovery more efficiently. Accordingly, applicants must assemble a collaborative public-private partnership consortium reflecting the integrative and cross-sectoral nature of IHI JU, that is capable of addressing the challenge(s) and scope of the IHI JU Specific Objective 1 ‘contribute towards a better understanding of the determinants of health and priority disease areas’, as defined in IHI JU’s legal basis¹ and described in more detail in the IHI JU SRIA².

Applicants should consider the following points in their proposals:

a) address an unmet public health need based on at least one of the below:

• the high burden of the disease for patients and/or society due to its severity and/or the number of people affected by it;
• the high economic impact of the disease for patients and society;
• the transformational nature of the potential results on innovation processes where projects are not focussed on individual disease areas (e.g. health data analytics);

b) demonstrate the ability to translate research into innovative solutions that can be integrated/implemented into the healthcare ecosystem (taking into consideration the fragmented nature of European healthcare systems) and/or in industrial processes;

c) carry out a landscape analysis to avoid unnecessary overlap and duplication of efforts with existing initiatives/projects and to identify potential synergies and complementarities with the relevant ones. The proposal should include a plan on how to synergise with these identified initiatives.

When applicable, proposals should consider relevant aspects of patient-centricity, with the help of the most suitable health technologies and/or social innovations, taking demographic trends into account as relevant.

In their proposals, applicants are expected to perform activities at scale that consider the different innovation cycles of the pharmaceutical and medical technology industries and drive concrete and transformational outcomes, in line with the first IHI JU General Objective³. In particular, the topic welcomes integrated pre competitive activities, including demonstration pilots, that could accelerate and improve the discovery, development and piloting of methods and strategies that facilitate the uptake of evidence-based practice and research outcomes into regular use (e.g. translation of results, deployment, uptake and piloting use in healthcare of novel treatments and healthcare solutions).

If applicable, applicants are expected to consider the potential regulatory impact of the anticipated project’s outputs, and, as relevant, develop a regulatory strategy and interaction plan for generating appropriate evidence and for engaging with regulators and other bodies in a timely manner, e.g. EU national competent authorities, notified bodies for medical devices and in-vitro diagnostic devices, health technology assessment (HTA) agencies, and the European Medicines Agency (EMA) through existing opportunities for regulatory support services, such as the Innovation Task Force and qualification advice.

As relevant, consideration should be given to the Health Data Access Bodies established under the European Health Data Space Regulation⁴ in the context of secondary use of data.

Applicants are strongly encouraged to consider relevant measures to provide open access to project generated outputs such as standards, data sets and other research results and, if relevant, share evidence on their clinical utility and economic aspects (efficiency).

¹ _{Article 115 of the Council Regulation (EU) 2021/2085 of 19 November 2021 establishing the Joint Undertakings under Horizon Europe}

² _{http://www.ihi.europa.eu/sites/default/files/flmngr/IHI_Strategic_Research_and_Innovation_Agenda_3.pdf}

3 ‘to contribute towards the creation of an EU-wide health research and innovation ecosystem that facilitates translation of scientific knowledge into innovations, notably by launching at least 30 large-scale, cross-sectoral projects, focussing on health innovations’

⁴_{http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202500327}