On Wednesday, the 10th of April 2024, the European Union’s parliament approved a package of rules that will make the pharmaceutical and cosmetic industries cover more of the costs of cleaning up their waste waters. With a vote of 481 in favour and 79 against, with 26 abstentions, Europe’s parliament rubber-stamped an accord it reached late January with member states on the revision of the Urban Wastewater Treatment Directive. Medicines and cosmetics are deemed to be the two main sources of micropollutants entering wastewater treatment plants.

More stringent rules

The text, which revises rules in place since 1991, drastically lowers to 1,000 inhabitants the threshold at which towns will be required by 2035 to eliminate all biodegradable organic materials before they can release their treated used waters into the environment.

Towns with more than 150,000 inhabitants will by 2039 have to remove all nitrogen and phosphorous, and by 2045 a wide range of micropollutants, with intermediate targets to reduce them in the meantime. Smaller towns (from 10,000 inhabitants) will also be concerned after 2045, under conditions. In addition, the text strengthens the monitoring of various public health parameters (such as known viruses and emerging pathogens), chemical pollutants, including so-called “forever chemicals” (per- and polyfluoroalkyl substances or PFAS), and microplastics.

In addition, the text introduces an energy neutrality target, meaning that urban wastewater treatment plants will have to progressively increase the share of renewable energy used each year (20% by 2030; 40% by 2035; 70% by 2040 and 100% by 2045 on average at the national level).

Pharmaceutical and cosmetic industries to pay

Most importantly, the package establishes the principle of "the polluter pays" by imposing greater contributions from the pharmaceutical and cosmetic industries. According to the EU, 59 percent of micropollutants in water treatment stations come from pharmaceutical producers and 14 percent from cosmetics.

These two sectors will be asked to cover 80 percent of the extra investments needed to eliminate micropollutants, with the remaining 20 percent covered by member states. The European Commission initially wanted industry to cover the full cost, but it dialled back its demands in order to avoid a burdensome financial impact on laboratories that would indirectly affect the prices of medicines, leading to unintended consequences on the availability, affordability and accessibility of the products.

“Underestimated” costs?

“We have ensured that the impact of this legislation on the affordability of medicines will not be disproportionate,” said Finnish MEP and rapporteur Nils Torvalds (Renew, FI).

The European Commission initially wanted industry to cover the full cost, but it dialled back its demands under pressure from the parliament and industry lobbyists.

“These treatment costs have been grossly underestimated and will fall mainly on affordable generic medicines,” the profitability margins of which are already low, Adrian van den Hoven, head of Medicines for Europe, protested in January.

According to the trade association, the new rules might negatively impact the production of medicines that are already in short supply. Medicines for Europe also highlights “the complexity or potential impossibility of replacing pharmaceuticals with greener alternatives.”

“We regret to see that only the pharmaceutical and cosmetics sectors will cover the Extended Producer Responsibility (EPR) system set up the legislation. We believe that every stakeholder contributing to micropollutants in the water must be part of any solution to enable the cleanest water possible,” added the European Federation of Pharmaceutical Industries and Associations (EFPIA.

Conversely, Aqua Publica Europea, the association of public water operators, welcomed the introduction of an Extended Producer Responsibility (EPR) scheme. However, the association regretted "the watering down of the initial Commission’s proposal with the introduction of national financing, which will create discrepancies across the internal market and risk driving competition between Member States."

The package must still be officially approved by the EU’s member states.