Europe prides itself on evidence-based, impact-assessed and consultative policymaking. Yet in the case of the Urban Wastewater Treatment Directive (UWWTD), these principles are being set aside with potentially disastrous consequences for thousands of patients across every Member State.
The Directive’s ambition is not in question. Protecting the health of the public and the environment is a shared objective, including for Europe’s generic medicines manufacturers. Across the sector, companies are already investing in advanced wastewater treatment, improving water efficiency and complying with stringent environmental standards at their production sites.
But good intentions do not make good policy. And in its current form, the Directive risks the Commission undermining one of the very systems it is meant to protect: access to essential medicines.
At the heart of the problem is a fundamental mismatch between policy design and the reality of pharmaceutical residues. The Directive’s Extended Producer Responsibility (EPR) model assumes that manufacturers are the primary source of emissions. They are not.
Most of the pharmaceutical residues in wastewater, which the Directive wants to charge for, come from patient use and excretion – an unavoidable consequence of delivering safe and effective treatments. The policy makers thinking of this as an industrial emission that should be controlled at source, or even worse, taxed at emission, really have got things the wrong way around.
This matters because policy built on the wrong premise, without robust evidence or consultative assessment on impact, will produce the wrong outcomes.
The evidence base underpinning the EPR scheme is, at best, flawed. It overstates the role and toxicity of certain medicines (a single medicine, Telmisartan, is claimed to represent 41% of the toxic load of the thousands of chemical residues in water whereas if assessed according to the environmental standards required by the European Medicines Agency, it would be less than 1%) while underestimating other contributors to the toxic load in waste water. At the same time, the projected costs of advanced wastewater treatment appear significantly underestimated. Legislating based on uncertain data while imposing open-ended financial obligations is not prudent policymaking, it is a gamble that will be paid for by patients.
Generic medicines account for the majority of treatments dispensed in Europe, more than 70% of dispensed medicines. They operate under strict pricing rules and low margins. Unlike others, this sector cannot simply absorb new costs or pass them on. Over the past decade, while prices for many goods have surged due to inflation — including essentials like bread, which rose by 42%—, the prices of generic medicines have been cut by 8%. The charges outlined in the current EPR model risk making essential treatments such as antibiotics, diabetes treatments, and epilepsy medicines commercially unviable. The predictable outcome is fewer suppliers and a risk of severe supply shortages that will affect access to medicines for many patients.
The Commission’s response – that a long implementation timeline will allow stakeholders to adapt – does not withstand scrutiny or reflect the reality of how major infrastructure projects are financed upfront. Expecting Member States to manage or correct these structural flaws at national level is neither realistic nor fair.
If anything, the current approach creates greater uncertainty; for manufacturers trying to plan production, for healthcare systems managing constrained budgets and for patients who rely on continuous access to essential treatments.
Europe does not have to choose between environmental protection and access to medicines. But achieving both requires policies grounded in robust evidence, proportionate design and a clear understanding of the impact on medicines. On these criteria, the current Directive falls short.
This is why the growing calls from Member States to “stop the clock” are not only justified, they are essential.
A pause is not a retreat from environmental ambition. It is a prerequisite for getting the policy right. It would allow for an independent reassessment of the Directive’s evidence base, a realistic evaluation of costs, and critically, a thoroughly researched and consultative impact analysis of the impact on generic medicines, the backbone of affordable healthcare for Europe.
Because the real test of European policy is not how important or well-founded it is on paper, but whether it actually delivers in practice.
A policy that seeks to protect the environment while undermining access to affordable medicines and the health of citizens is not a success. At a time of growing global uncertainty, when health security and resilient medicine supply are more critical than ever, it is a failure Europe can ill afford.
Adrian van den Hoven is the Director General of Medicines for Europe
Source:
www.euractiv.com