Despite years of negotiations over the EU’s Urban Wastewater Treatment Directive, implementation gaps and data inconsistencies continue to dog the political and industrial efforts.
The revised rules, which came into force on 1 January 2025, impose stricter obligations on the removal of micropollutants – particularly those that persist in the environment and accumulate in living organisms. Central to the overhaul is a new extended producer responsibility scheme requiring manufacturers to shoulder at least 80 per cent of the costs of advanced wastewater treatment across sources ranging from households to hospitals.
Brussels has singled out the pharmaceutical and cosmetics industries as the primary contributors to micropollution in urban effluents. Yet disparities in reporting by companies and member states have cast doubt on the reliability of impact assessments and the true scale of each sector’s contribution.
Amid mounting questions over data quality and regulatory fairness, the European Federation of Pharmaceutical Industries and Associations convened a debate at Euractiv on 17 March to probe the underlying issues.
Building on scientific evidence
Setting out the background, Veronica Manfredi, director for zero pollution and water resilience, at the European Commission’s environment department (DG ENV), said, “The revision has been building on scientific evidence that the type of substances that we really find hard to get rid of are micropollutants, particularly persistent bioaccumulative micropollutants. The fact is that the data reported by all 27 member states has pointed to this as a very persistent problem.”
“The revision that entered into force from 1st of January 2025 applies across the European Union, but only for bigger towns with a population of more than 150,000. We have introduced what we call the extended producer responsibility system, which means those who are responsible for having introduced these micropollutants into the water should contribute to financing the treatment cost.”
“[It’s] Important to underline they wouldn’t have to pay either for the primary, nor for the secondary, nor for the tertiary treatment. This is always paid by all of us citizens. It’s public money. It’s only for quaternary treatment,” she said.
MEP Tomislav Sokol, a member of the European Parliament’s public health committee (SANT) said that industry came to him in Autumn 2024 with a lot of concerns. They argued that the Commission’s impact assessment overstates the industry’s role in pollution and understates the financial impact on the sector, with estimated costs varying drastically between different studies.
“Essentially, we have different sets of data depending on who you speak to,” said Sokol.
“Firstly, the industry claims the Commission’s assessment overestimates the industry’s role in creating this toxic load that we have to clean from the wastewater, and it also underestimates the financial cost to the industry.”
One problem, two dimensions
“So here we have two dimensions of the problem, and these discrepancies are enormous – such big discrepancies that we definitely have to ask some questions,” said Sokol. “There has to be some methodological problem, because if we have one impact assessment that says that the annual effect of this will be €1.2 billion a year and other studies which say that it is more than €11 billion, that’s out by a factor of 10. So obviously there’s something wrong there, and we have to see what it is,” he remarked.
This has prompted calls to halt implementation until a more comprehensive and independent impact assessment is conducted. “We need a new, more detailed independent impact assessment to determine what the actual situation is because this is not something that we can afford to get wrong,” added Sokol.
Despite this, there was broad support on the panel for the EU’s environmental objectives, but opinions diverge on how these goals should be achieved and on the practical implementation of the directive.
Environmental economics milestone
Friederike Lauruschkus, global industry lead for water and wastewater at Ramboll said: “The UWWTD is a milestone in environmental economics for sustainable water ecosystems and health protection in Europe. At Ramboll, our approach is scientific. [So], it depends a lot on how you estimate the situation. What are the pollutants? What are the costs, and how do we distribute the costs between polluters?”
Lauruschkus added: “I think one important part of the wastewater treatment directive is that it starts now and has already different phases of evaluation embedded. So, there is time to really define how it will be implemented, how the regulations will be set, how the countries adapted, how flexibility is used and perhaps also which data and which methods have to be further developed to assess the pollution. And that’s why in our view it’s so important that the water sector and producers should work together to implement the responsibility for removing micropollutants,” she explained.
Vital for society, and environment
Representing the European drinking water and wastewater services association, Oliver Loebel, secretary general of EurEau, agreed with the need for collaboration. Pharmaceuticals and wastewater are two very different sectors, he said. At first glance, they do not appear to have much in common, “but when we look a bit closer, we are both active in the field of protecting public health. It’s our mission, and it’s the mission of pharmaceutical companies.”
“Of course, we also have a mission to protect the environment. We are both part of the one health approach. Important to note, we are both heavily regulated. We cannot set our prices ourselves. In addition, the wastewater sector is considered critical infrastructure. We deliver services that are essential to maintain vital societal functions under all circumstances.”
“I think we both recognise that there is a problem with pharmaceuticals in the environment, and I think we both recognise that urban wastewater treatment plants are an important pathway for these substances. If actions need to be taken at the ‘end of pipe’, which we do not prefer, but which is reality, then urban wastewater treatment plants have to play an important role. And I think we both even recognise that EPR is a tool to tackle that problem and must be fair and transparent. I think here we all agree. But the question is, of course, how do we define fairness?” said Loebel.
Fair burden-sharing indeed was a central concern of the panel. Responsibility is currently focused on just two industries.
The pharmaceutical sector acknowledges its role in environmental pollution but insists on a fair distribution of costs among all contributors. The panel highlighted that the EPR scheme must balance public health considerations as medications are essential for patients, raising concerns about potential shortages and price increases if costs are passed onto consumers.
Sustainable, fair and proportionate
This was echoed by Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA): “I’m sure we all share the same objective of having clean water in Europe, and that’s also something shared by the pharmaceutical industry. We support both the environmental and the public health ambitions of the directive. That’s something that should never be put into question.”
“I also think sometimes this topic is confused with a discussion about the production of medicinal products. This is not about production; this is really about the use of medicines by patients and the excretion of those medicines in our water, or the erroneous disposal of the products. I think it’s important to keep that in mind.”
“We recognise, of course, the presence of some of our products in the water,” said Moll, “I think the most important part for us is that there’s really a fair share of the cost of implementing the directive among all the polluters.”
“Not only because that will make sure that this is a sustainable, fair and proportionate application,” she said, “but also to incentivise the greening of all the sectors that are contributing to micropollution – not just of pharmaceutical products and cosmetics, which are the only two sectors that are being singled out at the moment. From a public health and an environmental point of view, we need to be very coherent with that.”
“I think it’s obvious that this should be done based on scientific evidence. But as far as we’ve seen, the data methodologies that have been at the base of this directive have not been fully disclosed or validated, as far as we’re concerned.”
Moll added: “Given the enormous impact not only on the pharmaceutical industry but most importantly on medicine supply and on patients dependent on medicines, a risk-benefit [analysis] based on access to medicines is something crucially important.”
“We would agree with pausing the implementation and taking a serious look at the data, assessing which other sectors could contribute to the scope of the directive and also doing a risk-benefit analysis in terms of what this means for the industries that have been singled out,” she noted.
This article follows the policy debate “Improving Europe’s water quality – How can the revised UWWTD be implemented fairly and effectively?” supported by EFPIA.
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