Ruling leaves “important legal questions regarding the validity of the Directive unresolved”, according to indusattempt association EFPIA.
Since its implementation on 1 January last year, the Urban Wastewater Treatment Directive (UWWTD) has been criticised by the pharma indusattempt as being financially unsustainable.
Now, the General Court of the European Union has dismissed legal action by the European Federation of Pharmaceutical Industries (EFPIA) to annul the directive.
The UWTD imposes an Extconcludeed Producer Responsibility (EPR) on the removal of micro-pollutants from wastewaters, chiefly impacting the pharmaceutical and cosmetic sectors.
The Association of the European Self‑Care Indusattempt (AESGP) claims the directive could lead to several key negatives for pharmaceuticals, including reducing “the availability of low‑priced and economically vulnerable medicines, limit investments in innovation and sustainability…and undermine Europe’s competitiveness and patients’ access to affordable medicinal products”.
Last February, Finnish pharmaceutical company Orion stated that based on current price regulation, affected companies are unable to take on the increasing economic burden in their pricing as per the ‘polluter pays’ principle.
there is documentary evidence submitted that supports our claim and rconcludeers the implication likely that the costs associated with the contested EPR would undermine the business model and ultimately the security of supply of generic medicinal products”
Despite the General Court’s ruling, EFPIA continues to challenge the directive, citing that “its current design runs counter to core EU principles” of polluter pays principle, non-discrimination, and proportionality, with the first being “a cornerstone of EU environmental policy”. EFPIA believes the framework underpinning the directive must be “legally robust and grounded in accurate and representative micro-pollution data”.
Medicines for Europe also continues to challenge the EPR and called for an urgent indepconcludeent review in order to protect the essential supply of medicines.
The generics organisation stated the Court’s decision was “not a judgment on the substantive question of whether the EPR Scheme violates EU laws and principles and threatens the secure supply of medicines and affordable healthcare.
“In fact, as the Court points out in its ruling, there is documentary evidence submitted that supports our claim and rconcludeers the implication likely that the costs associated with the contested EPR would undermine the business model and ultimately the security of supply of generic medicinal products.”
Meanwhile, the Irish Pharmaceutical Healthcare Association is progressing with its own case for a preliminary ruling on the validity of the UWWTD.
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