The Unmet Needs
The current strategy to assess environmental impact of pharmaceuticals in development is impracticable for assessing the 1000+ untested legacy pharmaceuticals that are not under patent because it would:
Additionally the current strategy is inappropriate for addressing legacy pharmaceuticals because it:
PREMIER will design a novel information and assessment system for identifying and addressing environmental risks of medicines, especially for those with limited data availability.
PREMIER will develop tools that identify and focus on medicines of potential concern amongst legacy pharmaceuticals; these tools could also be used to augment the current strategy for assessing of environmental impact of pharmaceuticals in development. Importantly, this system will be based on minimal animal testing.
A user-friendly and transparent database and assessment system
With the collaboration of public and private partners (industry, government, academia), PREMIER will develop a centralised, transparent, public and easily accessible database and tools which are evidence based. The data, tools and models generated in PREMIER will be integrated using innovative technologies, into a user-friendly information and assessment system accessible for all relevant stakeholders.
Minimising the environmental impact of medicines by developing future digital tools and guidance
The project will identify potential impacts and mitigation strategies to ensure the sustainability and long-term availability of effective medicines. We will develop a system to assess pharmaceutical ingredients that can be adopted and sustained by the EMA and other international agencies (WHO, JRC and OECD).