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 basis and described in more detail in the IHI JU SRIA:

Applicants should consider the following points in their proposals:

• 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).
• 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.

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

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.

Applicants should consider relevant existing initiatives/projects to ensure synergies and complementarities and avoid unnecessary overlap and duplication of efforts. The proposal should include a plan on how to synergise with these initiatives.

The actions to be funded under this topic are expected to achieve the following: contribute to one or more of IHI JU’s expected impacts linked to 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 benefitting 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.

contribute to strengthening 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.