EFPIA acknowledges the publication of the European Commission’s Environmental Omnibus package.   

We welcome the renewed commitment to simplifying regulation and reducing unnecessary administrative burdens and recognise this initiative as an important step toward ensuring that environmental goals are met through proportionate, predictable and innovation-friendly frameworks.  

We are disappointed to see that calls from the industry, Member States and European Parliament to include the urban wastewater treatment directive (UWWTD) have been disregarded. 

The revised UWWTD continues to rely on flawed toxicity assumptions and severely underestimated cost projections. Without corrective action, the obligations placed on the pharmaceutical industry under the UWWTD risk imposing disproportionate administrative and financial burdens, while creating real risks to the availability of medicines. The omission of these urgent adjustments fails to acknowledge the imminent potential impact on medicines across Europe.  

We regret to see the European Commission affirming that the updated cost study "are expected to be in line with assessments during the legislative procedure" without any clarity or transparency on the data used for the updated cost study. In addition, a study limited to updating costs and correcting for inflation rates does not constitute a robust or comprehensive sector assessment. 

As we have previously communicated, EFPIA has not been consulted on the study that aims to assess the impact on the concerned sectors, while the European Commission did not take into account cost estimates submitted by Member States and industry. These omissions are incomprehensible and increase our deep-rooted concern about the institutions' approach to this crucial file and they significantly compound our concern regarding the Commission’s approach to evidence-based policymaking and the proper evaluation of impacts on critical sectors such as healthcare and pharmaceuticals. 

EFPIA reiterates its call for the suspension of Articles 9 and 10 and Annex III of the UWWTD pending a proper assessment of impacts, alongside urgently needed harmonisation of Extended Producer Responsibility requirements. 

The pharmaceutical sector is ready to collaborate with policymakers to build a coherent and effective environmental framework that aligns Europe’s sustainability ambitions with its competitiveness, innovation capacity, and the secure supply of medicines for patients.