The Purposes:

• 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. 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.
• 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).

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.

Projects should 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.