Waste Water Directive: 10 billion tax for the European pharmaceutical industry

There is great concern on the part of the pharmaceutical industry about the economic and industrial impact of the EU wastewater directive, which threatens to place a disproportionate burden on companies. The EU Commission is said to have overestimated the environmental impact of pharmaceuticals by a factor of four and underestimated the costs to be incurred, which would be five to ten times higher. This would result in a tax of around 10 billion per year for pharmaceutical and cosmetics companies in Europe, instead of the 1.2 billion originally planned in the impact assessment. A real contradiction pointed out by Marcello Cattani, President of Farmindustria, and Michele Uda, Director General of Egualia, during the hearing at the Senate's EU Policies Commission, where the alarm was once again sounded over the legislation that has been in force since January 2025 'which makes waste water treatment standards for the removal of micropollutants unsustainable'.

The Italian pharmaceutical industry chain "reiterates the need to resolve the critical issues contained in the EPR (Extended Producer Responsibility) system, which, if introduced without changes, risks irreversibly compromising the sustainability of the sector and exacerbating the phenomenon of drug shortages, in contradiction with other initiatives of the European Union itself." "In a global context of fierce competition, geopolitical and trade tensions and a structural increase in operating costs of 30% compared to 2021," the pharmaceutical industry recalls, "Europe has already lost a lot of ground compared to the other major global macro-systems and is implementing measures such as the review of pharmaceutical legislation that will increase the gap with its main competitors.

This is why Farmindustria and Egualia ask the government to continue to strongly support in all available fora - starting with possible amendments to the Environmental Omnibus recently presented by the EU Commission - the need to suspend the application of the Directive in order to allow a new impact assessment by the deadline of 31 December 2028 for the entry into force of the EPR scheme.

The industry also urges the adoption of principles to safeguard access to medicines and the competitiveness of the pharmaceutical industry by applying the rules to all producers of micropollutants to contribute proportionately to their removal and by adopting a method of calculating contributions agreed upon by industry representative bodies.

The last request concerns the establishment of a single producer responsibility organisation per Member State, controlled by producers subject to EPR.