- The Prioritisation and Risk Evaluation of Medicines in the Environment (PREMIER) Innovative Medicines Initiative (IMI) project will design a novel information and assessment system for identifying and addressing the environmental risks of medicines, especially for those with limited data availability.
- PREMIER will develop a centralised, user-friendly and transparent database accessible for all relevant stakeholders such as regulatory agencies, pharmaceutical industry, water managers and environmental non-governmental organisations.
- PREMIER will achieve this thanks to an unprecedented consortium of 25 partners representing scientists from academia, industry, contract research organisations and regulatory bodies and well as IT specialists.
- PREMIER will explore the options to incorporate environment considerations earlier in the drug development process to inform drug design and to reduce the need of animal testing.
The project will identify potential impacts and mitigation strategies to minimise the environmental impact of medicines. Alongside the models and tools, PREMIER will develop manuals and guidance for to exploit and optimise the knowledge generated. The objective of the project is that the products developed by PREMIER would be adopted by the EMA and other national and international agencies (WHO, JRC and/or OECD) and used as a central resource by stakeholders to manage the environmental risks of human medicinal products across their lifecycle. PREMIER will facilitate the access to data and tools to regulators, environmental organisations and policy makers to promote a new standard for environmental protection across Europe. We will contribute to a sustainable future by proactively managing the environmental impact of medicines.
Today, the project launches its public website which contains all the relevant information about the consortium partners, project methodology as well as future access to the public database and assessment system.
Twenty-five world-leading institutions—including universities, research institutions, SMEs, regulatory agencies and pharmaceutical industry—are joining together to design a novel and evidence-based information and assessment system which will be publicly accessible by all stakeholders. The PREMIER partnership is being led by Radboud University Nijmegen and AstraZeneca AB, and it has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (IMI JU). IMI is the world’s biggest public-private partnership in life sciences, supported by the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
HOW PREMIER WORKS
The data and tools generated by the project will be publicly accessible by means of a user-friendly database and assessment system. Manuals and guidelines will be co-created with the relevant stakeholders to provide major insights into the feasibility of greener drug design. This initiative will ensure regulators and the scientific community can gain and share valuable knowledge to advance sustainable healthcare.
“Since 2006, the pharmaceutical industry has been required to carry out an environmental risk assessment for new medicines that they develop for sale in Europe. The European Medicines Agency (EMA) and national competent authorities are responsible for evaluating this,” says Professor Ad Ragas, associate professor at the Department of Environmental Science at Radboud University and as a full professor at the Open Universiteit in Heerlen, the Netherlands. “However, there are currently about 1,500 to 1,800 APIs on the market registered before 2006, for which no environmental risk assessment has been conducted. With this project, we hope to convince policymakers, but also pharmaceutical companies, water management companies, drinking water companies and hospitals, to assess these legacy medicines efficiently. Hopefully, this will be an impetus to implement new measures to better protect the environment.”
“The tools that we develop can in theory also be used to develop greener medicines. We will explore the feasibility of this during the project by initiating a dialogue between pharmaceutical development companies and environmental scientists.”
“The IMI PREMIER project is another example of how the pharmaceutical industry is proactively engaging with leading scientists to help ensure that patient access to life-changing medicines does not compromise environmental protection” says Professor Jason Snape, Global Head of Environment, AstraZeneca. “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.”