People and the planet benefit from medicines which have the smallest possible impact on nature yet maintain the highest medical efficacy and safety standards. Our aim is to minimise the burden of our products on the planet and accelerate the delivery of sustainable, net-zero healthcare. To achieve this, we follow the science to understand and address the environmental risks associated with our products.
One of these risks is pharmaceuticals in the environment (PIE), which is an unavoidable result of delivering life-changing medicines to patients. Pharmaceuticals enter the environment mainly from patient use, where some can pass through our bodies and into waterways. The Active Pharmaceutical Ingredients (APIs) found in our products are biologically active molecules which may interact with and impact wildlife and biodiversity when in the environment. We are committed to driving thought leadership and innovations to manage PIE. As the industry lead for PREMIER (which stands for Prioritisation and Risk Evaluation of Medicines in the EnviRonment), we are collaborating across our sector to develop tools to prioritise existing APIs in terms of their potential environmental risk and to identify environmental hazards of drugs in development. PREMIER is a six-year project started in September 2020 under the Innovative Health Initiative (IHI) – the world’s biggest public-private partnership in life sciences. It is co-ordinated by Radboud University and brings together a consortium of 27 public and private partners from the regulatory, pharmaceutical and research sectors (full list is given below).
Since 2006, as part of a medicine’s authorisation, Environmental Risk Assessments (ERAs) have been required in Europe to determine the future long-term chronic risks of human medicinal products to the environment. However, only a small proportion of around 1,900 products currently in use have been assessed, as most drugs approved prior to 2006 lack complete environmental data.
The key aims of the PREMIER project are therefore 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
- Explore the feasibility and practicality of greener drug design
- Develop a centralised, transparent public database and assessment system
Supported by the European Commission in partnership with the European Federation of Pharmaceutical Industries and Associations (EFPIA), the project benefits from more than 10 million euros of investment to fund the research objectives. The PREMIER project specifically aims to address the following themes of the European Strategic Approach to manage the environmental risks of pharmaceuticals:
- Explore the possibilities of developing pharmaceuticals which are lower risk for the environment
- Improve ERAs including via the 2019 Review (including a science-based catch-up system for APIs authorised prior to 2006)
- Expand environmental monitoring
- Addressing knowledge gaps for 25 priority medicines
PREMIER is tackling some very complex issues that are critical to better understand the risk of pharmaceuticals that reach the environment after patient use. We have already made great strides to develop better models to predict these risks, prioritise those with critical information gaps, better understand how we might design greener medicines in future, and identify what we could do to reduce the burden on laboratory animal studies.
Achievements to date
As of mid-2024, PREMIER has nine publications in peer reviewed journals, covering key topics including greener pharmaceutical design and an approach to reduce animal testing and environmental fate modelling. Approximately a third of the project’s deliverables have also been completed, and the focus is currently directed towards the remainder with more than 70 scientists and specialists working together on this programme. One key part will be an open and transparent database of the available environmental data of pharmaceuticals, with the first release planned to be publicly available by the beginning of 2025.
Consortium members
The consortium consists of:
- 13 pharmaceutical companies: AstraZeneca, along with Bayer, BMS, Eli Lilly and Company, GSK, Haleon, Janssen, MSD, Novartis, Reckitt, Roche, Sanofi and Servier.
- Regulatory community: The European Medicines Agency and the Dutch National Institute for Public Health and the Environment.
- University sector: University of Exeter, University of Gothenburg, University of Helsinki, Leuphana University, Radboud University and University of York.
- Research institutes: Swiss Federal Institute of Aquatic Science and Technology (EAWAG), the Fraunhofer Institute and the Mario Negri Institute.
- Three small enterprises: Ecologic, ECT and TEAM IT.
Our management of the risks associated with Pharmaceuticals in the Environment (PIE)
We recognise that, even in very low concentrations, the risks associated with PIE should be determined. Trace levels of pharmaceuticals in rivers, lakes, soils, and sometimes drinking water, could potentially impact aquatic life from low-level and long-term exposure. Learn more about our industry-leading approach to effectively managing the risks associated with Pharmaceuticals in the Environment in our PIE statement.
The PREMIER 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 Company'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.
