Brussels, 5 November 2024 – The European Federation of Pharmaceuticals Industry Association (EFPIA) and the Association of the European Self-Care Industry (AESGP), representing the human pharmaceutical industry in Europe, acknowledge, with some reservations, the approval by the Council of the European Union of the Urban Waste Water Treatment Directive (UWWTD).

While the associations support the overall objectives of the UWWTD and are fully committed to contributing to its effective, efficient and manageable implementation, we are extremely concerned of its negative impact on patient access to medicines and the global competitiveness of our sectors.

We strongly believe that the directive fails to comply fully to the EU principles of proportionality, non-discrimination and polluter-paying. The arbitrary decision to pick only two sectors, human pharmaceuticals and cosmetics, to pay for the pollution caused by others fails to incentivise greener product development of all polluters, undermining the European Green Deal.

We see these concerns being echoed across the European Union, with 16 Member States having released political statements with the approval of the UWWTD. Some statements underline the need to fully respect the polluter-pays principle, while others show concerns (1) on the implementing costs of Extended Producer Responsibility (EPR), (2) on only two sectors being appointed to finance these costs, and (3) on the unintended impact on availability and affordability of medicines. Many statements also call on the European Commission to carry out an urgent impact assessment on the directive that came out of the trilogue negotiations, focusing particularly on the impact on medicines.

Our companies and national associations are committed to collaborate with national policymakers to make sure that the directive is implemented in a fair, predictable, and non-discriminatory manner while ensuring access to medicinal products. To achieve this objective, EFPIA and AESGP are willing to work with our members as they lead the establishment of 27 Producer Responsibility Organisations together with other concerned industry associations and in consultation with the Commission, Member States and other stakeholders including water treatment management organisations.

We are hoping that all sectors that contribute to micro-pollutants in the water will be considered when implementing the UWWTD nationally, to ensure that the important issue of water pollution is addressed proportionately and fairly.

We also call upon the EU and national authorities working on the UWWTD’s implementation to ensure full alignment with the EU’s commitment to competitiveness and to work closely with the pharmaceutical industry during the transposition and implementation of the UWWTD.

Nathalie Moll, Director General, EFPIA, said: “The pharmaceutical industry is 100% behind the aims of the directive to reduce water pollution. How Europe decides to do this should be proportionate and fair. Questions remain regarding the legitimacy of a decision which sees just two sectors carrying the financial responsibility for cleaning of the entirety of societal micropollution”.

Jurate Svarcaite, Director General, AESGP, said: “Doing our best to protect the environment is a societal obligation for which we are all responsible. It seems to us, however, highly disproportionate that the modernization of sewage treatment plants, as well as their continued operations, should be funded solely by two sectors. A number of questions that may significantly impact overall costs of the EPR system remain unanswered by the legal text. Therefore, it is crucial that pharmaceutical industry takes a lead in implementing UWWTD, so that is cost-efficient, non-discriminatory and equitable, while ensuring the availability of and accessibility to quality treatments for the population.”

Notes to editors

• EU countries publicly raising concerns about the EPR and the impact on the industries: Czech Republic, Germany, Greece, Estonia, France, Italy, Cyprus, Latvia, Lithuania, Malta, Austria, Poland, Portugal, Romania, Spain, and Slovenia.
• Germany’s Environment Agency estimates for quaternary treatment costs range from €885 to €1,025 million annually – four times higher than the Commission’s figure of €238 million. Estimates from EurEau, the European Federation of National Associations of Water Services, indicate costs ranging from three to over nine times higher than the Commission’s numbers (between €3.6 and €11.3 billion per year).