EFPIA considers today’s Opinion of Advocate General Kokott concerning Poland’s challenge to the Extended Producer Responsibility provisions of the Urban Wastewater Treatment Directive1 an important development.  

The Advocate General recommends that the Court of Justice annul Article 9(1)(a) and Annex III of the Directive, which require pharmaceutical and cosmetics producers to finance at least 80% of the costs of quaternary wastewater treatment.   

The Advocate General concludes that the EU institutions did not clearly demonstrate that they had properly assessed the scientific evidence underlying the allocation of responsibility to these two sectors. In particular, the Advocate General identifies serious deficiencies in the methodology used to calculate toxic load, significant questions concerning the data used for certain pharmaceutical substances, and an insufficient assessment of other potentially relevant sources of micropollutants. She also finds that the selection of pharmaceuticals and cosmetics was not based on a scientifically substantiated comparison of all relevant sources of pollution.     

On that basis, the Advocate General finds that the legislature’s determination and assessment of the relevant evidence were affected by manifest errors.  

The research-based pharmaceutical industry fully supports the objective of protecting Europe’s water and is committed to paying its fair share towards tackling micro-pollution. However, we remain concerned that the system does not allocate the responsibility in a fair, proportionate and evidence-based way, and is not consistent with the EU’s polluter-pays principle.  

The Directive in its current form puts at least 80% of the costs of quaternary wastewater treatment on just two sectors - pharmaceutical and cosmetic - rather than reflecting the contribution of all relevant sources of micropollutants.  

Since the Directive was adopted, further evidence has raised significant questions about the methodology used to allocate toxic load and the basis on which responsibility was attributed to the pharmaceutical and cosmetics sectors. The Advocate General’s Opinion confirms that serious questions remain regarding the scientific basis used to allocate responsibility under the scheme.  

As well as disproportionate costs to pharmaceutical companies, the Directive in its current form is highly likely to impact European supply chains, creating the potential for medicines shortages, as well as undermining Europe’s ability to research and manufacture new medicines. * 

The European Parliament has already called for a new independent assessment of the impact of the Directive, including on the availability, affordability and accessibility of medicines. EFPIA believes this reassessment is essential.  

Nathalie Moll, Director General, EFPIA said: “EFPIA and our members have consistently requested that the urban wastewater treatment directive be reassessed due to concerns about the methodology and evidence used. Today, the Advocate General has also identified shortcomings in these areas and recommended that the relevant provisions be annulled. 

We now ask the European Commission to pause the implementation of the Directive while an adequate, comprehensive and transparent impact assessment is conducted to identify all relevant sources of micro-pollution. We look forward to working constructively with the Commission, Member States and other stakeholders on a solution that delivers cleaner water, ensures all sectors contribute fairly and protects patient care and access to medicines.” 

Notes to editors 

* Companies working in the pharmaceutical industry are tied into long-term, fixed prices, therefore they must absorb all costs created by the Directive; this is highly likely to impact on supply and availability of medicines for millions of patients as well as the competitiveness of the companies operating in Europe.