There are around 1900 active pharmaceutical ingredients (APIs) in use, yet the environmental risks of only a small proportion of these have been assessed. PREMIER will deliver a novel assessment system for characterising the environmental risks of APIs.  This project runs from September 2020 until August 2026.

This assessment system will be designed to screen and prioritise legacy APIs for a tailored environmental assessment; identify potential hazards associated with APIs in development; and to make relevant environmental data on APIs more visible and accessible to all stakeholders. To replace animal studies, model approaches will be developed.  Attention is also being paid to the development of 'green medicines' and the embedding of the results in the authorisation assessment and water quality management, through the development of a database that will become available to water quality managers. 

RIVM role

RIVM is work package leader of work package 4 (Guidance and Application), which involves developing guidance documents for stakeholders, to make optimal use of the results of the project. Furthermore, this work package involves Green drug design. We will explore the feasibility of greener drug design, and how environmental considerations may be incorporated in the drug development process. Work package 4 involves strong stakeholder participation. Besides this, RIVM participates in work package  2 (developing models which may replace animal models, and developing exposure models) and work package 3 (developing a database and assessment system, and quality assurance of data for 25 case study compounds).  Because RIVM leads work package 4, RIVM is also part of the management team of the project.

The strength of this proposal lies in the link between the environment and health care. In recent years, we have gained much expertise in this area of our organisation. RIVM is seen as a European leading expert in a large number of the areas in which we are working in this project. This project offers the opportunity to continue with the overarching theme and to bring RIVM's strength, the connection between the domains, into play.

RIVM colleagues involved: Caroline Moermond (work package leader management board), Emiel Rorije, Eric Verbruggen and Bastiaan Venhuis.

Funding

PREMIER is an Innovative Medicines Initiative (IMI) project. RIVM is part of a consortium with 15 European partners (including the European Medicines Agency) that is funded through Horizon 2020. The other half of the consortium are industry partners who fund themselves.

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N0 875508.