The Bulgarian government has submitted a national declaration as part of the legislative dossier concerning the revised Urban Wastewater Treatment Directive. Sofia expressed strong reservations about the implementation of the revised European directive on urban wastewater treatment, citing concerns over the increased burden placed on EU countries.
“The Republic of Bulgaria expresses concern regarding the significant challenges linked to implementation of the revised Directive, stemming from stricter requirements for treated water quality and expanded monitoring obligations,” the health ministry told Euractiv.
‘Wiggle room’ in implementation needed
Bulgaria is calling for greater flexibility in how EU countries apply the legislation, while also demanding stronger support mechanisms to facilitate compliance.
According to the ministry, implementation should include measures aimed at “reducing the financial burden on member states and protecting citizens from increases in service prices”. The concerns add to a wider debate surrounding the revised EU framework, which introduces stricter environmental obligations and significantly broadens responsibility for wastewater treatment.
Deyan Denev, executive director of ARPharM Bulgaria, has warned that essential medicines could disappear from the Bulgarian market if parts of the directive are implemented without adjustment. The recast EU legislation introduces a “polluter pays” principle, requiring the pharmaceutical and cosmetics sectors to finance at least 80% of the costs of removing micropollutants from wastewater systems.
While the European Commission argues that the measure is necessary to improve water quality and reduce environmental contamination, industry organisations such as the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Medicines for Europe launched legal challenges.
Lower-income countries hit harder
The pharmaceutical sector argues that the legislation unfairly targets specific industries and could contribute to medicine shortages across Europe. Industry representatives warn that the consequences may be particularly severe in lower-income and tightly regulated markets such as Bulgaria. Manufacturers supplying publicly reimbursed medicines are not permitted to raise prices in order to offset additional environmental compliance costs.
An EFPIA analysis provides indicative estimates of the potential price impact if pharmaceutical pricing were not legally capped.
According to estimates referenced in the debate, the price of paracetamol could rise by between 12% and 45%, based on European Commission calculations. However, Germany’s Federal Environment Agency suggests increases could range from 24% to 90% across different European markets.
The price of metformin, widely prescribed for blood glucose control in patients with Type 2 Diabetes, could increase by approximately 48%, according to Commission estimates, while German environmental modelling places the increase as high as 96%.
The sharpest increases in production costs are expected to affect high-volume, low-margin medicines.
[VA, BM]
Source:
www.euractiv.com