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:

• Socio-economic science and humanities

eligible non-EU countries:

• countries associated to Horizon Europe

• 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.

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.

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