The legislation creating IHI sets out a series of general, specific and operational objectives for the programme, but how are these bullet points in a legal text translated into real-life projects working on real-life challenges in health? The answer lies in the Strategic Research and Innovation Agenda, which focuses on the specific objectives of IHI:
- Improve our understanding of the factors that affect our health and the development and treatment of certain diseases.
- Integrate fragmented health research and innovation efforts by bringing together health industry sectors and other stakeholders. This will enable the development of tools, data, platforms, technologies and processes that will in turn facilitate the prevention, diagnosis, treatment and management of diseases, especially in areas where there is an unmet public health need.
- Demonstrate the feasibility of integrated healthcare solutions that draw on various technologies from different sectors and address the needs of the people who will use them, such as patients and healthcare professionals.
- Make better use of opportunities to gather health data and use it in research and care, all while respecting relevant privacy legislation.
- Develop ways of assessing the value of innovative, integrated health care solutions to patients, carers, healthcare professionals and organisations, and other stakeholders.
For each specific objective, the SRIA explains in detail the current challenges; how IHI could address them; and suggests potential outputs for IHI projects and, crucially, the medium to long-term impacts.
For example, potential outputs under specific objective 1 (on improving our understanding of the factors that influence our health and diseases) include biological markers to diagnose diseases or monitor patients’ response to treatment or tools to improve the tracking of infectious disease outbreaks. Expected impacts under this objective include earlier diagnosis of diseases studied or better preparedness of EU healthcare systems in case of disease outbreaks.
Project ideas involving a specific disease are selected based on the burden of the disease for patients / society due to its severity or the number of people affected; and the economic impact of the disease for patients/society. This is because the IHI SRIA does not list a specific set of diseases on which IHI projects should focus. Project ideas that do not focus on a disease are assessed based on the extent to which their results could have a transformational impact on innovation processes.
The SRIA emphasises that the work supported by IHI should be pre-competitive, meaning it will not deliver products or services directly into healthcare systems or the market. As such, IHI projects are expected to focus on the following kinds of activities:
- discovery of new molecules, mechanisms of action, processes, technologies;
- development and testing of these discoveries;
- development of methodologies for the assessment of safety, health outcomes, or for health-economic evaluation;
- pre-standardisation activities;
- contributions to regulatory science;
- pilots / proofs of feasibility, including in silico (i.e. virtual) trials.
In 2019, around 100 different stakeholders, including academic institutions, healthcare professionals and patients, responded to a public consultation on the first draft of the SRIA. This consultation paved the way for a second draft, prepared jointly by the European Commission and the IHI industry partners, COCIR, EFPIA (including Vaccines Europe), EuropaBio, and MedTech Europe. The IHI Governing Board formally adopt the SRIA in January 2022.
The SRIA is a living document. It will be updated, with the support of the Science and Innovation Panel and the States Representatives Group, throughout the duration of Horizon Europe to take into account future developments in health research.