Environmental risks posed by human medicinal products

Medicinal products

Rome [ENA] The Innovative Medicines Initiative (IMI) has its origins in the European Technology Platform (ETP) on Innovative Medicines that was supported under the European Commission's Sixth Framework Programme for Research (FP6). Called ‘INNOMED’, the European Technology Platform gathered together a range of stakeholders and was led by the pharmaceutical industry. The project ran from 2005 to 2009 and laid the foundations

IMI

for IMI by developing a Strategic Research Agenda to boost drug development in Europe, and by delivering proof of the efficiency of a collaborative approach in two key areas: Alzheimer’s disease and medicines safety. A new, intriguing IMI project is to apply innovative approaches to ensure the environmental safety of human medicinal products such that both environmental concerns do not become a barrier to patient access to medicines, and the use of medicines does not pose an unacceptable risk to the environment. Active ingredients from medicines can get into the environment through a variety of routes, and once there they can prove harmful to wildlife and ecosystems.

This project aims to refine, extend, validate and implement approaches to the prioritizing and testing the environmental safety of established medicinal products. Pharmaceuticals are present in the environment as an effect of patient use, manufacture, and improper disposal. They predominantly enter the aquatic environment via patient use. In the European Union (EU) an environmental risk assessment (ERA) is required as part of the marketing application and approval for new drugs. Currently the environmental risk assessment is carried out late in drug development and often parallel to Phase III clinical trials and after significant investment.

The growing regulatory and scientific concerns concerning pharmaceuticals in the environment have reached the point where some interested parties are supporting the inclusion of environmental hazard and risk within the patient-benefit evaluation that underpins the marketing authorization of a drug Moreover a catch-up scheme for medicines authorized for use prior to 2006 that lack comprehensive environmental assessments and an increased transparency of environmental data. Increased consideration of environmental properties in drug development (i.e. greener drug design) is also required.

However, without validated tools to predict environmental risk earlier in drug development these stakeholder expectations could influence the availability of life-changing medicines to patients within Europe and impact the competitiveness of the industry. This project aims to develop an EU-wide pharmaceutical ecotoxicology database. Applicants should also indicate how their proposal will impact the competitiveness and industrial leadership of the European Union by, for example, engaging suitable small and medium-sized enterprises (SMEs).For complete information, please see the IMI2 Call 17 topic text. http://ec.europa.eu/research/participants/portal/desktop/en/opportunities/h2020/topics/imi2-2019-17-03.html