The Spanish Association of Generic Medicines (AESEG) has celebrated the decision of the Government of the Netherlands to postpone the implementation of the Extended Producer Responsibility (EPR) obligations included in the European directive on the treatment of urban wastewater, pending a ruling from the Court of Justice of the European Union (CJEU) on its legality.
According to AESEG, the Dutch Executive considers that "important questions" remain about how to deploy this model without causing undesirable effects, including possible tensions in the supply of medicines, which is why it has opted to wait for greater legal certainty before making definitive decisions.
This move comes shortly after the Advocate General of the CJEU recommended declaring invalid the rules that establish who should bear the costs of the EPR system and to what extent. In her conclusions, the Advocate General questions the scientific and methodological basis used to attribute to pharmaceutical manufacturers and the cosmetics industry the funding of at least 80 percent of the costs of the quaternary treatment of wastewater.
Furthermore, the Advocate General has emphasized the importance of the procedure initiated in Ireland by organizations in the pharmaceutical industry, confirming that the debate on the legal robustness of the current scheme remains open at the community level.
These developments come after the European Parliament approved a resolution in June urging the European Commission to conduct a new impact assessment and to temporarily suspend the EPR system until sufficient evidence is available regarding its effects on access to medicines and supply security.
BALANCE BETWEEN ENVIRONMENT AND ACCESS TO MEDICINES
AESEG insists that it shares the central objective of the Directive to strengthen environmental protection. However, it considers it essential that future national regulations ensure an adequate balance between environmental preservation and effective access to medicines.
In this sense, the association argues that the studies available so far indicate that the application of the RAP system, in the terms in which it is configured, could jeopardize the economic viability of certain essential low-cost medicines, with potential impact on their availability and on the sustainability of the National Health System.
Similarly, it emphasizes that decisions regarding investment, industrial planning, production, and supply will have to be made "much earlier" than when the system actually comes into operation. "Without an adequate solution, there is a risk that some medicines will cease to be economically sustainable, which could translate into supply reductions, product withdrawals, or lower manufacturing capacity in Europe," it warns.
CALL FOR A REVIEW OF THE MODEL
For AESEG, the position adopted by the Netherlands, the resolution of the European Parliament, and the recent conclusions of the Advocate General of the CJEU point in the same direction: "The need to carefully review the design of the RAP system before continuing to advance its application."
The generics employers' association sees it as essential to introduce specific safeguards for essential and low-cost medicines, study modulation formulas, and address national transposition processes with the utmost caution.
In this line, it argues that the protection of the environment and public health must progress in a coordinated manner. "Europe cannot afford for environmental regulation to end up compromising access to essential and critical medicines, weakening its strategic autonomy or jeopardizing the supply security objectives that inspire initiatives like the Critical Medicines Act," concludes the association.