Bulgaria calls for review of EU wastewater directive over medicine supply concerns
Health Minister of Bulgaria Katya Ivkova took part in a regular meeting of the EU Employment, Social Policy, Health and Consumer Affairs Council, held in Luxembourg, the Health Ministry said on its website.
At Germany’s initiative, the health ministers of the Member States were informed of developments related to the impact of the extended producer responsibility introduced by the Urban Wastewater Treatment Directive on the supply of medicinal products. Bulgaria, Germany, Greece, Sweden, Poland, the Netherlands, Italy, Lithuania, Estonia, Czechia, Romania, France and Luxembourg all backed the need to seek solutions, expressing shared concern that the Directive could affect the availability and prices of medicines, CE Report quotes BTA.
Ivkova called for an objective analysis of the data in an impact assessment to prevent adverse consequences for the healthcare sector and patients. "Until a legislative revision is carried out, Bulgaria’s preferred solution, as stated in a national declaration accompanying the adoption of the Directive, is to postpone its implementation," Ivkova said, as quoted by the Ministry.
She noted that she expects future discussions at European level to be organized with the mandatory participation of the sectors affected by the Directive, including healthcare.
The Council approved by qualified majority a general approach on two directives: one on placing genetically modified microorganisms (GMMs) on the market and another on quality and safety standards for human organs intended for transplantation. Ivkova welcomed the compromise reached but said the balance should be preserved during the trilogue talks, given the high public sensitivity of the issue. She also called for the texts to be aligned in the next stage of negotiations with the recommendations of the European Data Protection Supervisor.
The ministers also discussed the Regulation which is part of the European Biotech Act I. Bulgaria expressed principled support for measures to promote biotechnology production in the EU in view of the opportunities to strengthen the Union’s strategic autonomy, while at the same time emphasizing the need to preserve a balance between innovation and safety, the Health Ministry said.
The ministers also discussed strengthening Europe’s pharmaceutical resilience and strategic autonomy. Ivkova reaffirmed Bulgaria’s consistent position on the need for a balance between industrial objectives and health policies. She stressed that the organization, financing and strategic planning of health systems are an exclusive national competence and should not be subject to mandatory EU measures.
Photo: Health Ministry
