Commission: New wastewater rules will not jeopardise access to medicines

The EU Commission rejected a warning from pharmaceutical companies that extended producer responsibility (EPR) under the proposed revision of the wastewater directive could jeopardise access to medicines.

“The Commission paid a lot of attention to the possible consequences of this extended producer responsibility scheme,” a spokesperson from the EU executive told EURACTIV, citing the impact assessment, various scientific publications and “a feasibility study of applying producer responsibility to micropollutants”.

The EPR is part of the Commission’s proposed revision of the Urban Wastewater Treatment Directive, aimed at cleaning up rivers, lakes, groundwaters and the sea while making wastewater treatment more “cost-effective”.

EPR is part of the proposed solution to remove micro-pollutants in Europe’s wastewater, requiring polluters to cover the cost.

The Commission also argued that it will “incentivise research and innovation into toxic-free products, as well as making financing of wastewater treatment fairer”.

This is bound to hit pharmaceutical companies – 66% of the micro-pollutants in EU wastewater come from pharmaceuticals, a spring Commission report showed.

So, in line with the Treaty of the EU’s Article 191(2), “the polluter should pay”.

Pushback from pharmaceutical companies

However, following the presentation of the revision, representatives for the pharmaceutical industry, the Association of the European Self-Care Industry (AESGP), Medicines for Europe and the European Federation of Pharmaceutical Industries and Associations (EFPIA) warned that it could harm access to medicines by pushing up medicine prices.

“Forcing producers to bear the costs of wastewater treatment would create additional costs for marketing authorisation holders. It could increase prices of medicinal products or even put medicinal products out of their financial viability, in particular in smaller markets and low-priced products,” the group told EURACTIV.

“Therefore, there could be unintended negative impacts on the availability of medicines, which would reduce access to treatment options to patients,” they added, calling for pharmaceuticals to be considered “essential and critical public goods”.

They also highlighted the work of the pharmaceutical industry in the Eco-Pharmaco-Stewardship programme, aimed at reducing pharmaceutical residues in the environment.

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Commission set on EPR

The Commission, however, is set on the EPR, following a series of studies and a subsequent impact assessment.

“According to these studies, the proposal will not hinder the accessibility or affordability of pharmaceuticals: the maximum average increase in the cost of pharmaceuticals is estimated at €1.9-2.4 per year/per person by 2040 (or 0.6-0.7% price increase) when the legislation will produce its full effects in 2040,” the spokesperson said.

“This is a maximum in case the industry decides to pass the full cost of the EPR scheme on to their consumers. The industry can also decide to cover these costs or part of it by taking them from their profit margins,” the spokesperson added.

The Commission also highlighted that EPR schemes for collecting and treating solid waste stemming from the use of pharmaceuticals are in place in 10 member states already.

This, they say, has not had an effect on affordability or access so far “as the costs of the system are also marginal compared to the price and the profit margins of the pharmaceuticals”.

The pharmaceutical industries’ alternative to EPR would be “solidarity-based models, distributing costs of water treatment upgrade amongst society” using a Swiss cost-sharing funding model for improving urban wastewater treatment plants (UWWTPs) as an example.

The Commission spokesperson did not reply directly to questions about the “solidarity model”, but added that “the EPR scheme will precisely ensure a distribution of the cost amongst the full chain contrary to possible alternatives (taxes or increase of water tariffs).”

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Green by design

Another concern from the pharmaceutical industry is about the Commission’s hopes to incentivise greener pharmaceuticals.

“Applying Extended Producer Responsibility to human medicines, to incentivise the development of ‘green by design’ products, does not account for the biological nature of medicines’ action nor for the complexity of medicines authorisation,” the group argued, as the authorisation is based on quality, safety, and efficacy requirements.

Despite being confronted with this, the Commission believes it will make a change and incentivise the production of less hazardous products.

“As detailed in the proposal, the fees to be paid by those placing pharmaceuticals on the EU market will be linked with the hazardousness of the residues and the quantities placed on the market,” the Commission’s spokesperson continued.

That being said, the spokesperson admitted that it is not possible for a range of pharmaceuticals as “there is no ‘green’ alternative for the moment, in that case, modest price increases or reduction of profit margins can be expected”.

[Edited by Gerardo Fortuna/Nathalie Weatherald]

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