Medicines for Ireland, alongside our colleagues in Medicines for Europe, are seriously concerned about the impact of the Urban Wastewater Treatment Directive (UWWTD). The direct economic impact of the directive could lead to massive shortages of essential and critical medicines in Ireland and across Europe if implemented in its current form.

Our members are engaged in making water cleaner and safer. We closely monitor, manage and minimise pollution from discharge waters at manufacturing sites. Pharmaceutical residues are mainly present in European waters due to human consumption and subsequent excretion by patients.

The UWWTD Extended Producer Responsibility (EPR) tax presents an unprecedented challenge. Only the pharmaceutical and cosmetics sectors will have to finance the upgrades of wastewater treatment plants across Europe to introduce the quaternary treatment required to remove persistent substances from all sectors, as well as the operational costs.

Generic medicines are the backbone of European healthcare systems, representing 7 out of 10 dispensed medicines and 9 out of 10 critical medicines while accounting for just 19% of the market value. In Ireland, 58% of medicines of all prescribed medicines in 2023 were generic medicines.

Affordable generic medicines costing just a few euros a day are particularly vulnerable to the UWWTD EPR system due to their high volumes and strictly capped prices. Extra costs on off-patent medicines would create an existential threat to Europe’s medicines supply, leading to severe disruptions, compromising patient access to affordable essential and critical medicines and undermining efforts to invest in more resilient medicines manufacturing in the context of the Critical Medicines Alliance.

Although the legislation has been formally adopted by the EU Council, we are relieved that Austria, Czechia, Germany, Estonia, Spain, France, Greece, Italy, Latvia, Lithuania, Malta, Poland, Portugal, Romania and Slovenia have all identified the serious concerns about how the EPR system will apply and the impact this will have on the availability of essential and critical medicines.

We call on the EU to immediately reassess the impact of the UWWTD on medicines availability. As we prepare to enter negotiations on the Framework Agreement on the Supply and Pricing of Medicines, we will call on the Department of Health to take long-overdue market reforms on pricing policies for essential and critical medicines to protect the supply of medicines for patients in Europe.