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[[COM(2019) 128 final; Section 5.2]] and the Pharmaceutical strategy for Europe[[COM(2020) 761]] called for diversifying and secure supply chains and environmentally sustainable pharmaceuticals[[https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52020DC0761&from=EN]]. 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.