EFPIA welcomes the clear call addressed to the European Commission by the European Parliament to conduct a new independent study and to evaluate the potential impacts of the Directive on the availability, affordability and accessibility of medicines, including critical medicines, as well as a temporary suspension of the EPR obligation.

EFPIA and member companies have raised concerns over a number of years, that key elements of the Directive are not aligned with the EU principles of proportionality, non-discrimination and the polluter-pays principle.  

The decision to allocate the costs of quaternary treatment exclusively to the human pharmaceutical and cosmetics sectors also fails to reflect the contribution of all relevant sources of micropollutants. This situation risks severely impacting supply chains and companies’ ability to manufacture and innovate in Europe and subsequently harms patient care and access to medicines.  

EFPIA will continue to work constructively with EU institutions and stakeholders to ensure the Directive delivers environmental benefits while safeguarding the availability of medicines for patients across Europe. 

Nathalie Moll, Director General, EFPIA, said: “Today’s outcome is a step in the right direction and will be welcomed by all companies working in the research based pharmaceutical industry in Europe. Conducting an independent and robust study is the right approach to ensuring that every sector that contributes to micropollutant emissions should also contribute fairly to the costs of addressing them. The pharmaceutical industry has been clear that it supports the directive, on the basis that it is implemented fairly and proportionately.”