AstraZeneca is leading a new 6-year project with the Innovative Medicines Initiative (IMI), focused on the Prioritisation and Risk Evaluation of Medicines in the EnviRonment (PREMIER).
The IMI is a public-private partnership between pharmaceutical companies, the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Following the success of the 5-year IMI project Intelligent Assessment of Pharmaceuticals in the Environment (iPIE), which concluded in June 2019, we are now launching the PREMIER project on 1 September 2020.
Led by AstraZeneca and Radboud University, along with nine other pharmaceutical companies (Bayer, BMS, Eli Lilly and Company, GSK, MSD, Novartis, Roche, Sanofi and Servier), the European Medicines Agency, nine other research institutes (Dutch National Institute for Public Health and the Environment, University of Exeter, EAWAG, Fraunhofer Institute, University of Gothenburg, University of Helsinki, Leuphana University, Mario Negri Institute and the University of York) and four Small Medium Enterprises (Ecologic, ECT, Simomics and TEAM IT), the project aims to deliver an innovative framework for characterising the environmental risks of active pharmaceutical ingredients (APIs), which can be used to:
- Develop tools and models to identify potential environmental hazards and risks associated with APIs earlier in development
- Screen and prioritise legacy APIs authorised for use prior to 2006 for a tailored environmental assessment
- Explore the feasibility and practicality of greener drug design
- Make environmental data on APIs more visible and accessible to all stakeholders
Supported by the European Commission, the project benefits from €10 million investment to fund the research objectives. The PREMIER project specific aims to address the following themes of the European Strategic Approach to manage the environmental risks of pharmaceuticals:
- Support the development of pharmaceuticals which are less harmful for the environment and promote greener manufacturing
- Improve environmental risk assessments (ERAs) and its review (including a science-based catch-up system for APIs authorised prior to 2006)
- Expand environmental monitoring
- Fill other knowledge gaps, reducing the data gap for pre-2006 drugs
The IMI PREMIER project is another example of how we are leading the way in environmental protection and mitigating the risk of pharmaceuticals in the environment. Investing in this project will allow us to assess and reduce the environmental risk of our products so we can continue to deliver medicines to patients, without compromising our commitment to sustainability.
How we are mitigating the environmental risks associated with APIs
As a responsible healthcare company, we are committed to the health and safety of our society and planet. We make it a priority to effectively manage the risks associated with Pharmaceuticals in the Environment (PIE).
Pharmaceuticals enter the environmental mainly as a result of patient use, where they can pass through our bodies and into waterways. Drug manufacturing and the improper disposal of unused medicines also add to the trace levels of pharmaceuticals in rivers, lakes, soils, and, sometimes, drinking water, resulting in the release of APIs into the environment. Some pharmaceuticals have been implicated in potential impacts on aquatic life from low-level and long-term exposure.
There are around 1,900 APIs in use, yet the environmental risks of only a small proportion of these has been assessed. In 2006, the requirement for Environmental Risk Assessments (ERAs) came into force in Europe requiring the long-term chronic risks of human medicinal products to be determined as part of their authorisation; many drugs approved prior to 2006 lack complete environmental risk assessment data. This has resulted in an urgent need to develop pragmatic approaches for prioritising existing APIs in terms of potential environmental risk and for identifying environmental hazards of drugs in development.
Due to high attrition rates, the ERA for pharmaceuticals is typically conducted late in pharmaceutical development; in many cases these environmental studies are conducted in parallel to Phase III clinical trials. It is envisaged that the tools developed by PREMIER will enable environmental consideration to be integrated earlier within the drug development process.
As well as technical goals, such as predicting the hazard and environmental risk of future drugs, the PREMIER project aims to improve governance and data transparency across the industry. In addition, PREMIER provides an opportunity to build networks and partnerships, bringing together those who have an interest in green drug development and innovative medicine.
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 875508. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: The above communication reflects the author's view and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.