New waste water regulations will not hinder access to medicines, says Commission

The European Commission has rejected a warning from pharmaceutical companies that extended producer responsibility (EPR) under the proposed revision of the waste water directive could jeopardize access to medicines.

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

REP is part of the review proposed by the Commission of the Urban Waste Water Treatment Directive, which aims to clean up rivers, lakes, groundwater and the sea while making waste water treatment more “profitable”.

EPR is part of the proposed solution to remove micropollutants from European wastewater, asking polluters to cover the cost.

The Commission also indicated that it “will encourage research and innovation in the field of non-toxic products, while making the financing of wastewater treatment fairer”.

This measure will not fail to affect pharmaceutical companies: according to a report published in the spring, 66% of micropollutants in EU wastewater come from pharmaceuticals.

Thus, in accordance with Article 191(2) of the EU treaty, “the polluter must pay”.

Reaction from pharmaceutical companies

However, following the presentation of the review, representatives of the pharmaceutical industry, the European Specialty Pharmaceuticals Association (AESGP), Medicines for Europe and the European Federation of Pharmaceutical Industries and Associations (EFPIA) warned that it could harm access to medicines by driving up drug prices.

“Forcing producers to bear the costs of wastewater treatment would create additional costs for marketing authorization holders. This could increase drug prices or even put drugs out of financial viability, especially in small markets and low-priced products.”the group told EURACTIV.

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

They also highlighted the work of the pharmaceutical industry in the program Eco-Pharmaco-Stewardshipaimed at reducing pharmaceutical residues in the environment.

The Commission decides on EPR

However, the Commission has decided on EPR, following a series of studies and a subsequent impact assessment.

“According to these studies, the proposal will not impede 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 (i.e. a price increase of 0.6-0.7%) when the legislation takes full effect in 2040”said the spokesperson.

“This is a maximum if the industry decides to pass on the full cost of the EPR system to its consumers. The industry can also decide to cover these costs or a part of them by taking them from its profit margins”said the spokesperson.

The Commission also pointed out that EPR systems for the collection and treatment of solid waste from the use of pharmaceuticals are already in place in 10 Member States.

According to the Commission, this has had no effect on affordability or access to care so far “because the costs of the system are also marginal compared to the price and profit margins of pharmaceuticals”.

The alternative to EPR proposed by the pharmaceutical industries would lie in “solidarity models, spreading the costs of improving water treatment within society”taking as an example a Swiss model of shared-cost financing for the improvement of urban wastewater treatment plants (WWTPs).

The Commission spokesperson did not respond directly to questions about the “model of solidarity”but nevertheless clarified that “the EPR system will precisely guarantee a distribution of costs over the whole chain, unlike the other possible solutions (taxes or increase in water prices)”.

“Green by Design” Products

Another concern of the pharmaceutical industry relates to the hopes placed by the Commission in the promotion of more ecological pharmaceutical products.

“The application of extended producer responsibility to human medicines, in order to encourage the development of ‘green by design’ products, does not take into account the biological nature of the action of medicines or the complexity of the authorization of medicinal products », the group said. Indeed, the authorization is based on quality, safety and efficacy requirements, they argued.

Despite this, the Commission believes that this measure will bring about change and encourage the production of less dangerous products.

“As stated in the proposal, the fees to be paid by those placing pharmaceuticals on the EU market will be linked to the dangerousness of the residues and the quantities placed on the market”said the spokesperson for the Commission.

The spokesperson admits, however, that this is not possible for a whole series of pharmaceutical products, because “there is no alternative” ecological ” for the moment. In this case, expect modest price increases or reduced profit margins”.

New waste water regulations will not hinder access to medicines, says Commission