Call: Development, procurement and responsible management of new antimicrobials

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Programme

Horizon Europe - Cluster 1 - Destination 6: Maintaining an innovative, sustainable and globally competitive health industry

Acronym

HORIZON-HLTH-IND

Type of Fund

Direct Management

Description of programme
"Horizon Europe - Cluster 1 - Destination 6: Maintaining an innovative, sustainable and globally competitive health industry"

Calls for proposals under this destination are directed towards the Key Strategic Orientation KSO-A ‘Promoting an open strategic autonomy by leading the development of key digital, enabling and emerging technologies, sectors and value chains’ of Horizon Europe’s Strategic Plan 2021-2024. Research and innovation supported under this destination should contribute to the impact area ‘A competitive and secure data-economy’ and in particular to the following expected impact, set out in the Strategic Plan for the health cluster: ‘EU health industry is innovative, sustainable and globally competitive thanks to improved up-take of breakthrough technologies and innovations, which makes the EU with its Member States more resilient and less dependent from imports with regard to the access to and supply of critical health technologies’. In addition, research and innovation supported under this destination could also contribute to the following impact areas: ‘Industrial leadership in key and emerging technologies that work for people’, ‘High quality digital services for all’, and ‘Good health and high-quality accessible health care’.

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 health care 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. 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 order to address these challenges, in particular green and digital transitions and proper supply of health technologies and products, destination 6 will focus on research and innovation activities that aim at:

Production of pharmaceuticals in compliance with the objectives of the European Green Deal.
Methodologies, guidelines and standards, assessment studies, and structuring activities adapted to digital solutions and interventions for GDPR compliant translation into health care practice, including inter-operability, cyber-security and data confidentiality.
Public authorities supported with better methodologies and interdisciplinary approaches to assess and value new health technologies and interventions.
Development of pharmaceutical products meeting unmet medical needs in the context of market failures.

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, the development and adoption of best practices, or joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic but also between other projects funded under another topic, cluster or pillar of Horizon Europe (but also with ongoing projects funded under Horizon 2020). In particular, this could involve projects related to European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic challenges on health and EIT-KIC Health (under pillar III of Horizon Europe), or in areas cutting across the health and other clusters (under pillar II of Horizon Europe). For instance, with cluster 4 “Digital, Industry and Space” such as on industrial research and innovation infrastructures (pilot plants, testing and simulation facilities, open innovation hubs); additive manufacturing (3D/4D printing) and other production technologies (incl. bio manufacturing); safe, smart and sustainable materials.

Expected Impacts:

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

Health industry in the EU is more competitive and sustainable, assuring European leadership in breakthrough health technologies and 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 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, health care providers, health authorities and regulators ensuring suitability and acceptance of solutions.
European standards, including for operations involving health data, ensure patient safety and quality of healthcare services as well as effectiveness and interoperability of health innovation and productivity of innovators.
Citizens, health care providers and health systems benefit from a swift uptake of innovative health technologies and services offering significant improvements in health outcomes, while health industry in the EU benefits from decreased time-to-market.
Health security in the EU benefits from reliable access to key manufacturing capacity, including timely provision of essential medical supplies of particularly complex or critical supply and distribution chains, such as regards vaccines or medical radioisotopes.

Link

Link to Programme

Call

Development, procurement and responsible management of new antimicrobials

Description of call
"Development, procurement and responsible management of new antimicrobials"

Expected Outcome

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable and globally competitive health industry”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:

Health authorities and healthcare providers have identified the needs and potential procurers;
Potential procurers are ready to establishing an innovation partnership for the development and the procurement of new antimicrobials;
Potential procurers are able to engage and commit financially in view of the establishment of an innovation partnership.

Scope:

The aim of this topic is to prepare for the establishment of a pull incentive for new antimicrobials where there is an unmet public health need and a market failure. In line with the Pharmaceutical Strategy for Europe that was published in November 2020 innovative approaches at EU level should be developed for supporting research, development and public procurement of antimicrobials to address the issue of antimicrobial resistance. These approaches could make use of European legislation, such as the possibility of an innovation partnership that would allow for the combination of development of new antimicrobials and procurement elements and should be tailored to public health needs.

To that end, a preparatory phase is necessary. Proposers are expected to create the conditions for the establishment of a future innovation partnership. They should take advantage of the latest developments such as experiences gained within Europe on the advance purchase agreements for COVID-19 vaccines. With the help of experts, potential procurers of new antimicrobials in the Member States have to set out the requirements and conditions for the final product(s) to be developed and purchased. This will needs to be guided by public health needs and should be based on priority pathogens such as those identified by WHO. These requirements and conditions needed to guide development will have to be developed with input of scientific experts and in close collaboration with Commission services, and need to be agreed upon with a view of EU Member States’ and Associated States commitments to purchase the new antimicrobials. Proposers should also develop a broad communication strategy towards stakeholders and other potential procurers.

Proposals are expected to address all of the following:

Emerging health threats, particularly those resulting from antimicrobial resistance (AMR), and identification of relevant public health needs in the development of new antibiotics.
Design of a feasible option for a pull incentive that combines EU support for late stage development of antimicrobials with procurement by Member States and Associated Countries (implementation of the pull incentive will be beyond the scope of this CSA).
Readiness and interest of potential developers/suppliers of antimicrobials
Market failures and the challenges of availability and accessibility of therapeutics.
Conditions for development and purchase of new antimicrobials.
Requirements for financing.
Conditions for prudent use of new antimicrobials.

Cross-cutting Priorities:

Link

Link to Call

Thematic Focus

Clustering, Development Cooperation, Economic Cooperation, Research & Innovation, Technology Transfer & Exchange, Health, Social Affairs, Sports, Capacity Building, Cooperation Networks, Institutional Cooperation

Funding area

EU Member States
Overseas Countries and Territories (OCTs)
United States of America

Origin of Applicant

EU Member States
Overseas Countries and Territories (OCTs)
United States of America

Eligible applicants

Education and Training Centres, Federal State / Region / City / Municipality / Local Authority, Research Institution, Lobby Group / Professional Association / Trade Union, International Organization, Small and Medium Sized Enterprises, SMEs (between 10 and 249 employees), Microenterprises (fewer than 10 employees), NGO / NPO, Public Services, National Government, Other, Start Up Company, University, Enterprise (more than 250 employees or not defined), Association

Applicant details

eligible non-EU countries:

countries associated to Horizon Europe

At the date of the publication of the work programme, there are no countries associated to Horizon Europe. Considering the Union’s interest to retain, in principle, relations with the countries associated to Horizon 2020, most third countries associated to Horizon 2020 are expected to be associated to Horizon Europe with an intention to secure uninterrupted continuity between Horizon 2020 and Horizon Europe. In addition, other third countries can also become associated to Horizon Europe during the programme. For the purposes of the eligibility conditions, applicants established in Horizon 2020 Associated Countries or in other third countries negotiating association to Horizon Europe will be treated as entities established in an Associated Country, if the Horizon Europe association agreement with the third country concerned applies at the time of signature of the grant agreement.

low-and middle-income countries

Legal entities which are established in countries not listed above will be eligible for funding if provided for in the specific call conditions, or if their participation is considered essential for implementing the action by the granting authority.

Specific cases:

Affiliated entities - Affiliated entities are eligible for funding if they are established in one of the countries listed above.
EU bodies - Legal entities created under EU law may also be eligible to receive funding, unless their basic act states otherwise.
International organisations - International European research organisations are eligible to receive funding. Unless their participation is considered essential for implementing the action by the granting authority, other international organisations are not eligible to receive funding. International organisations with headquarters in a Member State or Associated Country are eligible to receive funding for ‘Training and mobility’actions and when provided for in the specific call conditions.

Project Partner

Yes

Project Partner Details

Unless otherwise provided for in the specific call conditions , legal entities forming a consortium are eligible to participate in actions provided that the consortium includes:

at least one independent legal entity established in a Member State;and
at least two other independent legal entities, each established in different Member States or Associated Countries.

Further info

Proposal page limits and layout:

The application form will have two parts:

Part A to be filled in directly online (administrative information, summarised budget, call-specific questions, etc.)
Part B to be downloaded from the Portal submission system, completed and re-uploaded as a PDF in the system

Page limit - Part B: 30 pages

Type of Funding

Grants

Financial details

Expected EU contribution per project	The Commission estimates that an EU contribution of around EUR 2.00 million would allow these outcomes to be addressed appropriately. Nonetheless, this does not preclude submission and selection of a proposal requesting different amounts.
Indicative budget	The total indicative budget for the topic is EUR 2.00 million.
Typ of Action	Coordination and Support Actions (CSA)
Funding rate	100%

Submission

Proposals must be submitted electronically via the Funding & Tenders Portal Electronic Submission System. Paper submissions are NOTpossible.