Optimising the manufacturing of Advanced Therapy Medicinal Products (ATMPs)

Topics under this destination are directed towards the Key Strategic Orientation 3 “A more resilient, competitive, inclusive, and democratic Europe” of Horizon Europe’s strategic plan 2025-2027. In addition, Key Strategic Orientation 2 “The Digital Transition” and Key Strategic Orientation 1 “The Green Transition” are supported.

Research and Innovation supported under this destination should contribute to the following expected impact, set out in the strategic plan impact summary for the Health Cluster: “the EU health industry is innovative, sustainable, and globally competitive thanks to improved uptake of breakthrough technologies and innovations (including social innovations) that make the EU with its Member States and Associated Countries more resilient and less reliant on imports of critical health technologies”.

The health industry is a key driver for growth and has the capacity to provide health technologies to the benefit of patients and providers of healthcare services. The relevant value chains involve a broad variety of key players from supply, demand and regulatory sides. In addition, the path of innovation in health is long and complex. The development of novel health technologies is generally associated with uncertainties and market barriers due to expensive and risky development (e.g., high attrition rate in pharmaceutical development), high quality and security requirements (e.g., clinical performance, safety, data privacy and cybersecurity) and market specificities (e.g., strong regulation, pricing and reimbursement issues). In addition, the growing concern about environmental issues is putting more pressure on this industry. Therefore, there is a need for Research and Innovation integrating various stakeholders to facilitate market access of innovative health technologies (medical technologies, pharmaceuticals, biotechnologies, digital health technologies).

In this work programme part, Destination “Maintaining an innovative, sustainable and competitive EU health industry” focuses on collaborative efforts to advance manufacturing processes and activities to ensure increased knowledge on and a faster uptake of medical devices and in vitro diagnostic medical devices in the current EU regulatory context. The results will support the EU Industrial Policy, with a focus on strengthening the resilience of the single market, addressing the EU’s strategic dependencies, gaining technological sovereignty and accelerating the green and digital transitions. In addition, the results will further strengthen the single market, by implementing the Digital Single Market strategy, providing evidence and guidelines for stakeholders and regulators to ensure take-up of innovations, supporting environmental, fiscal and socio-economic sustainability while fostering healthcare access and reducing health inequities. The results will also support the implementation of the Regulations on Medical Devices (MDR) and In Vitro Medical Devices (IVDR) and the Pharmaceutical Strategy for Europe, especially aspects related to the importance of ensuring industry competitiveness, innovation and sustainability and the development of high quality, safe, effective, and greener medicines.

In view of increasing the impact of EU investments under Horizon Europe, the European Commission welcomes and supports cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities such as the participation in joint workshops, the exchange of knowledge, development and adoption of best practices, or joint communication activities. All topics are open to international collaboration to address global environment and health challenges.

In particular, the topics under this destination will support activities aiming at: i) optimising the manufacturing of Advanced Therapy Medicinal Products (ATMPs) with the ultimate aim that healthcare providers, researchers and patients get faster access to ATMPs with demonstrated health benefits for unmet medical needs; ii) advance digitalisation of conformity assessment procedures in the context of medical device and in vitro diagnostic medical device development; iii) facilitating and enabling improved knowledge on the conduct of multinational clinical studies of orphan devices and/or highly innovative (“breakthrough”) devices.

Expected impacts:

Proposals for topics under this destination should set out a credible pathway to contributing to maintaining an innovative, sustainable and competitive EU health industry, and more specifically to one or several of the following expected impacts:

• Health industry in Europe and Associated Countries is more competitive and sustainable, assuring European leadership in breakthrough health technologies and open strategic autonomy in essential medical supplies and (digital) technologies, contributing to job creation and economic growth, in particular with small and medium-sized enterprises (SMEs).
• Health industry is supported by cross-sectoral Research and Innovation in the context of convergence of health technologies (integrating medical technologies, pharmaceuticals, biotechnologies, digital health, and e-health technologies) while strengthening key market positions.
• Health industry is working more efficiently along the value chain from the identification of needs to the scale-up and take-up of solutions at national, regional or local level, including through early engagement with patients, healthcare providers, health authorities and regulators ensuring suitability and acceptance of solutions.
• Citizens, healthcare providers and health systems benefit from a swift uptake of innovative health technologies and services through the provision of evidence and guidelines for stakeholders, policymakers and regulators. These efforts offer significant improvements in health outcomes, also potentially strengthening access to healthcare for all and reducing health inequities while health industry benefits from decreased time-to-market.
• Citizens, healthcare providers and health systems benefit from increased health security in Europe and Associated Countries due to reliable access to key manufacturing capacity, including timely provision of essential medical supplies and technologies of particularly complex or critical supply and distribution chains.

Legal entities established in China are not eligible to participate in Innovation Actions in any capacity. Please refer to the Annex B of the General Annexes of this Work Programme for further details.

The protection of European communication networks has been identified as an important security interest of the Union and its Member States. Entities that are assessed as high-risk suppliers^[1] of mobile network communication equipment (and any entities they own or control) are not eligible to participate as beneficiaries, affiliated entities and associated partners to topics identified as “subject to restrictions for the protection of European communication networks”. Please refer to the Annex B of the General Annexes of this Work Programme for further details.

[1] Entities assessed as “high-risk suppliers”, are currently set out in the second report on Member States’ progress in implementing the EU toolbox on 5G cybersecurity of 2023 (NIS Cooperation Group, Second report on Member States’ progress in implementing the EU Toolbox on 5G Cybersecurity, June 2023) and the related Communication on the implementation of the 5G cybersecurity toolbox of 2023 (Communication from the Commission: Implementation of the 5G cybersecurity Toolbox, Brussels, 15.6.2023 C(2023) 4049 final).

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