The European Commission has approved, under EU State aid rules, the second health-related Important Project of Common European Interest ('IPCEI') to support innovations in medical devices. This includes the introduction of novel digital and artificial intelligence ('AI') features in medical devices. The IPCEI will support collaborative research and innovation, as well as the first industrial deployment of these frontier technologies.
The project, called 'IPCEI Tech4Cure', was jointly notified by five Member States: France, Hungary, Italy, Slovakia and Slovenia.
The Member States will provide up to €403 million in public funding, which is expected to unlock an additional €826 million in private investments.
As part of this IPCEI, 10 companies will undertake highly innovative research and development and first industrial deployment projects. Six of these companies are small and medium-sized enterprises ('SMEs').
Tech4Cure mainly focuses on the creation of innovative medical devices with advanced and novel digital/AI solutions, which aim to further develop the predictive, preventive, and personalised medicine ('3P medicine') concept.
Predictive medicine uses data and analytical tools to predict future health risks of individuals. Preventive medicine allows the early detection of risk factors and medical conditions to timely intervene and prevent diseases. Personalised medicine adapts treatments and care plans to the unique characteristics of each individual patient.
The 3P medicine concept improves patient outcomes, reduces healthcare costs, and improves EU citizens' quality of life.
Tech4Cure will contribute to the updated Industrial Strategy , by promoting industrial resilience and reinforcing the Single Market. It will encourage the competitiveness of the EU medical devices industry and support the green and digital transitions with advanced, safe, and innovative medical technologies. In turn, this will strengthen the EU's healthcare value chain.
The completion of Tech4Cure is planned for 2036, with timelines varying in function of the individual projects and the companies involved. According to the participating Member States, the projects are expected to create around 800 jobs.
The Commission assessment
The Commission assessed the proposed project under EU State aid rules, more specifically its 2021 Communication on Important Projects of Common European Interest ('IPCEI Communication'). Where private initiatives supporting breakthrough innovation do not materialise because of the significant risks such projects entail, the IPCEI rules enable Member States to jointly fill the gap, to overcome these important market failures. At the same time, the IPCEI rules ensure that the EU economy at large benefits from the supported investments and limit potential distortions to competition.
The Commission has found that Tech4Cure fulfils the required conditions set out in the IPCEI Communication. In particular, the Commission concluded that:
- Tech4Cure directly contributes to achieving several EU objectives of a greener, more secure, and resilient economy, as well as a more accessible healthcare set out in key EU policy initiatives, such as the European Health Union , the Clean Industrial Deal , the European Industrial Strategy and its update, the new European Research Area , the European Digital Strategy , the European Health Data Space and the European Action Plan on the Cybersecurity of Hospitals and Healthcare Providers .
- All 10 projects which are part of the IPCEI are highly ambitious, as they aim at developing technologies that go beyond what the market currently offers and are expected to result in major innovations. This includes the areas of cardiovascular diseases, paediatrics and neonatal care, oncology, and ophthalmology.
- The IPCEI also involves significant technological and financial risks. Therefore, public support is necessary to provide incentives to companies to carry out their investment.
- Aid to individual companies is limited to what is necessary and proportionate, and does not unduly distort competition. In particular, the Commission has verified that the total planned maximum aid amounts are in line with the eligible costs of the projects and their funding gaps. Furthermore, if large projects covered by the IPCEI turn out to be very successful, generating extra net revenues, the companies will return part of the aid received to the respective Member State through a claw-back mechanism.
- The results of the project will be widely shared by participating companies with the European scientific community and industry, beyond the companies and countries that are part of the IPCEI. As a result, positive spillover effects will be generated throughout Europe.
On this basis, the Commission concluded that the project is in line with EU State aid rules.
Funding, participants and structure of the IPCEI
The IPCEI involves 10 projects from 10 companies. These projects include over 70 planned collaborations with other partners in the wider IPCEI ecosystem.
The companies and projects were selected by the Member States, based on a set of national and IPCEI criteria such as contribution to EU objectives; highly ambitious in terms of research and innovation; to overcome market or systemic failures, and; generate positive spillover effects in the EU.
The figure below presents the overall structure of IPCEI Tech4Cure, including the individual workstreams:
The 10 projects are part of the wider IPCEI Tech4Cure ecosystem, which also involves 18 associated partners, from four Member States (France, Hungary, Latvia and Slovenia). There are in addition around 45 indirect partners, which can be companies or research organisations that will benefit from the creation of an EU medical devices ecosystem because of the activities within Tech4Cure and from dissemination activities of the results of the IPCEI Tech4Cure.
The figure below presents the overall structure of the IPCEI Tech4Cure and its wider ecosystem, including the individual projects:
From the beginning, the Commission was actively involved in the design phase of this IPCEI. The Commission provided technical and scientific expertise, as well as guidance on how to structure Tech4Cure around a common objective. Based on this pilot experience, it then launched the IPCEI Design Hub.
To facilitate SME participation, the Commission provided guidance and support on IPCEI rules and draft project portfolios in meetings with Member States, and direct participants. SMEs were able to use simplified templates, and the Commission services organised early feedback sessions to help interested SMEs prepare their projects. This has resulted in 60% of direct participants of the IPCEITech4Cure being SMEs.
Background
In March 2022, 16 Member States signed a joint Manifesto towards a health IPCEI, in which they declared their support for two IPCEIs. The first one, concerning innovation in the pharmaceutical industry, materialised in the IPCEI Med4Cure, and this second one, IPCEI tech4Cure, focuses on medical devices with novel digital and AI features.
Today's Commission decision concerns the eleventh integrated IPCEI approved under EU State aid rules. All of these were approved on the basis of the IPCEI Communication, setting out the criteria under which several Member States can support transnational projects of strategic significance for the EU under Article 107(3)(b) of the Treaty on the Functioning of the European Union . The Communication aims at encouraging Member States to support highly innovative projects that make a clear contribution to economic growth, jobs, and competitiveness in the EU.
The IPCEI Communication complements other State aid rules such as the General Block Exemption Regulation and the Framework for State aid for research and development and innovation, which allow supporting innovative and green projects whilst ensuring that potential competition distortions are limited.
The non-confidential versions of the IPCEI decisions will be made available under the case numbers SA.113212 (France), SA.117899 (Hungary), SA.117859 (Italy), SA.117793 (Slovakia), and SA.117849 (Slovenia) in the State Aid Register on the competition website once any confidentiality issues have been resolved. New publications of state aid decisions on the internet and in the Official Journal are listed in the State Aid Weekly e-News .
