The conference should be seen in the broader context of the current revision of the EU general pharmaceutical legislation, which will tackle, inter alia, environmental challenges related to pharmaceutical residues. As mentioned in the introductory remarks delivered by MEP Cristian Silviu Bușoi (EPP, Romania), the outcomes of the conference will contribute to the upcoming legislative discussions around the file.
Of particular relevance for the in silico medicine community is the emphasis put by one of the speakers on the potential of predictive models to design medicines with low or no environmental impact.
- Various studies have demonstrated that some medications, including antibiotics, pain relievers, and cancer therapies, have direct effects on wildlife, even in extremely low quantities. However, filling key data gaps – e.g. on the environmental impact of each compound, as well as the mixture (cocktail effects) of different compounds – remains one of the main challenges in this field, as identified by the panel.
- In addition, experts stressed the need to support research projects in the field of environmentally sustainable medicines, e.g., by providing specific funding for academic/industrial research or with accelerated registration processes conducted by the European Medicines Agency (EMA). To this regard, Prof. Patrick Kestemont (President of Research Institute of Life, Earth & Environment, University of Namur) called on the EU and the Member States to adopt ad hoc legislations to support pharmaceutical companies with the development of environmentally friendly drugs.
- Dr Brigitte Simon-Hettich (Head of Early Chemical and Preclinical Safety, Merck Group) stressed the importance of promoting predictive models to design medicines with low or no environmental impact.
- Hans Stielstra (Deputy Head of Unit of Sustainable Freshwater Management, DG ENV, European Commission), highlighted how one of the main aims of the upcoming proposal for a revision of the EU general pharmaceuticals legislation, to be published “in a few months”, will be to improve the current legislation in terms of environmental risk assessment provision.
- In her conclusive remarks, MEP Sirpa Pietikäinen (EPP, Finland) called on the Commission to include the costs of “non-action” in the upcoming impact assessment.