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Call: Green pharmaceuticals

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Programme
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
Green pharmaceuticals
Description of call
"Green pharmaceuticals"

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 some of the following expected outcomes:

  • Researchers and regulators understand the environmental impact of pharmaceuticals.
  • Public authorities inform pharmaceutical strategies and polices based on scientific evidences.
  • Researchers, innovators and pharmaceutical industries develop and produce greener pharmaceuticals that are either greener by design, intrinsically less harmful for the environment, and/or use greener and economically more sustainable manufacturing processes for the production of pharmaceuticals.

Scope:

The EU needs to address the increasing problem of environmental pollution due to pharmaceuticals throughout their life cycle. This encompass both, the industry need to tackle the pollution due to their manufacturing as well as pollution resulting from the use and disposal of their pharmaceuticals. This topic is part of an EU strategic approach to pharmaceuticals in the environment and the Pharmaceutical strategy for Europe called for diversifying and secure supply chains and environmentally sustainable pharmaceuticals. The purpose of this topic is twofold.

One of the purposes is to encourage taking into account the environmental aspects of pharmaceuticals as regards their use and disposal. The action intends to promote the development of pharmaceuticals intrinsically less harmful to environment. As regards the pharmaceuticals already in use, more understanding is needed concerning their environmental concentration and resulting levels of risk. In particular, the solid knowledge of the impact of molecules on the environment through the eco-toxicity studies will contribute to management of environmental risk and may be taken into account for designing of new molecules.

The second purpose is to promote the green innovation in the pharmaceutical manufacturing of marketed medicinal products, in particular manufacturing of their active pharmaceutical ingredients (APIs). It will contribute to ensuring supplies of medicinal products and prevent shortages as well as crisis preparedness. The difficulties in ensuring compliance with the high environmental standards in the EU and high costs of such compliance are considered one of the main reason for pharmaceutical manufacturing leaving the EU. This in turn results in vulnerabilities of the supply chains (reduced number of suppliers of critical inputs, lack of geographical diversification of the suppliers, lack of critical manufacturing capacity in the EU). The new, greener and sustainable manufacturing methods, which would for the reason of lowering the environmental impact rely on recycled solvents, would need at the same time to address the risk of impurities.

Applicants should propose activities linked to several of the following elements:

  • Research and innovation to support the development of “greener” pharmaceuticals that degrade more readily to harmless substances in waste water treatment plants and the environment;
  • Research on the eco-toxicity and environmental fate of pharmaceuticals, in particular those that are not yet subject to environmental risk assessment;
  • Propose innovative manufacturing technology that are greener, low in energy consumption and emissions, using less solvent or recycling solvents;
  • Propose methods for eliminating carcinogenic impurities in pharmaceuticals (e.g. nitrosamines) process and medicinal products, in particular as complementary technologies to the manufacturing methods relying on recycled solvents;
  • Explore innovative uses of digital transformation or robotic for competitive and scalable methods of production.

The projects should favour a multi-stakeholders approach. They should address the industry needs, taking account of SMEs’ specificities, and offer deployable technical solutions and/or relevant data. They should also integrate at the same time the academic and public health perspective.

Proposals could consider the involvement of the European Commission's Joint Research Centre (JRC) in the field of new approach methodologies for ecotoxicity assessment.

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.

The Joint Research Centre (JRC) may participate as member of the consortium selected for funding.

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: 45 pages

Type of Funding Grants
Financial details
Expected EU contribution per projectThe Commission estimates that an EU contribution of around EUR 8.00 million would allow these outcomes to be addressed appropriately. Nonetheless, this does not preclude submission and selection of a proposal requesting different amounts.
Indicative budgetThe total indicative budget for the topic is EUR 40.00 million.
Typ of ActionResearch and Innovation Actions (RIA)
Funding rate100%
Submission Proposals must be submitted electronically via the Funding & Tenders Portal Electronic Submission System. Paper submissions are NOTpossible.

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