The PREMIER Project: environmental awareness and sustainability in the Pharma and Life Sciences sector
Activities within the Pharma and Life Sciences sector raise a number of environmental considerations. Drug discovery processes require a large amount of energy and can place a strain on the natural environment.
Contamination of waterways, air and land can occur during the drug manufacturing process and as a result of incorrect disposal methods. Drugs also pass into waterways following use by patients.
With the backdrop of a more environmentally conscious world, those working within the Pharma and Life Sciences sector are taking proactive steps to make drug discovery, manufacturing and usage greener and more sustainable.
What is the regulatory landscape?
In the UK and Europe, there is an expansive regulatory framework that aims to combat the environmental issues associated with industry in general, including regulations in relation to emissions, waste management and disposal. There are additional rules relating specifically to the Pharma and Life Sciences sector, which pursue the same objectives (such as the requirement to conduct environmental risk assessments as part of the regulatory approval process). It is crucial that those working within the sector familiarise themselves with the applicable regulations, particularly as penalties for breach of environmental laws can include fines and imprisonment (if officers are individually prosecuted).
Many pharma and life sciences companies have also implemented their own ecopharmavigilance (ie identifying and managing the environmental issues in connection with their processes and end products). Engaging in ecopharmavigilance is not only useful for assessing and demonstrating compliance but demonstrates an appetite for sustainability and responsible working, which is an important consideration for many prospective partners.
The PREMIER Project
The Prioritisation and Risk Evaluation of Medicines in the EnviRonment (PREMIER) Project is an example of how those in the sector can tackle environmental issues through collaboration. The project is a six-year initiative that was established in 2020 with funding from the Innovative Healthcare Initiative (a public-private partnership in the life sciences sector).
As described on the PREMIER project website, the project is run by a consortium made up of (1) pharmaceutical companies, including AstraZeneca, (2) members of the regulatory community, including the EMA, (3) representatives from the university sector, including the University of Exeter, together with (4) research institutes and (5) small and medium size enterprises.
The PREMIER project describes on its website the following aims centered on fostering sustainability within the Pharma and Life Sciences sector:
- Creating tools and models to identify potential environmental hazards and risks associated with active pharmaceutical ingredients (APIs) early on in the development process;
- Ensuring that there is complete environmental risk assessment data for drugs which were approved prior to the requirement for environmental Risk Assessments (ERAs), which came into force in 2006 for European countries;
- Exploring the feasibility and practicality of greener drugs; and
- Developing a centralised, transparent public database and assessment system.
What has been achieved so far?
As discussed on its website, the project has had success in completing a number of its deliverables, including the selection of APIs which did not have a reliable ERA but are considered to pose a substantial environmental risk, so that these can be investigated and assessed further.
The PREMIER project also details on its website that it is developing a database and Digital Assessment System (DAS) which will make environmental data more visible and accessible for the industry, regulators and the wider public. It is anticipated that the first public release will be available by the start of next year. It will be interesting to see what this data reveals and the questions it will raise: what are the most common environmental impacts?; which medicines cause the greatest harm to our environment?; will these considerations influence pharma and life sciences companies to pursue certain R&D projects or look to make existing medicines greener? It will also be interesting to see how other parties will harness and build on this work. Watch this space!
As reported on its website, the project has additionally published several articles in peer reviewed journals which cover topics such as greener pharmaceutical design, animal testing (the reducing of) and modelling environmental fate. This bank of articles is a good source of inspiration for those looking to explore sustainability issues within the sector and also serves to highlight useful next steps, such as improving the dialogue between R&D and environmental scientists and introducing incentives to promote greener pharmaceuticals.
We eagerly await the first release of the DAS early next year and we are excited to see more results from PREMIER's work in this important area.
The theme of the PING Conference for 2025 will be Sustainability - what must pharma do now?