The EU Discussed the Critical Medicines Act

The Minister of Health, Assoc. Prof. Silvi Kirilov, MD, PhD, participated in the regular meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO, Health session) in Brussels, Belgium, the Ministry of Health reports.

During the meeting, the Council approved a general approach to the Critical Medicines Act. Minister Kirilov emphasized that for Bulgaria, the negotiations will be guided by the principles of subsidiarity and proportionality, as well as respect for the competencies of Member States regarding the organization and financing of healthcare, including public procurement, pricing, reimbursement, and strategic planning.

The Republic of Bulgaria supported the balance achieved in the text, which was approved by all Member States except Belgium, which abstained. National declarations were presented by Bulgaria and Italy, according to the Ministry of Health.

Ministers also discussed progress on the “Pharmaceutical Package”—a key legislative proposal for the regulation of medicinal products in the EU. Bulgaria highlighted the need to maintain a balance between the interests of all parties and patient protection, as well as the ability of states to maintain autonomy when negotiating quantities and prices of medicines according to national needs and capabilities, the Ministry of Health states.

The next trilogue is scheduled for December 10, and the publication of the Health Package, including a revision of the medical devices regulations and a proposal for a Biotechnology Act, is expected on December 16. A Cardiovascular Health Plan will also be presented on the same date.

Among the topics discussed was the Urban Wastewater Treatment Directive, presented by Czechia and supported by 13 countries. Ministers expressed the need for an objective cost study and discussed the potential impact on the availability and prices of medicines in the EU.

A working discussion among ministers was also held on the topic of “New Tobacco and Nicotine Products: Impact on Children and Young People.” Assoc. Prof. Kirilov highlighted the alarming trends related to the attractiveness and marketing of these products and presented the successful Bulgarian initiative “Health Ambassadors,” which involved 9,000 children across the country in 2025.

Other issues discussed included the European Health Union, the EU Climate and Health Strategy, the EU Cardiovascular Health Plan, and the Union’s Health Crisis Prevention and Response Plan. Cyprus presented its priorities in the health sector as it prepares to take over the rotating Presidency of the Council on January 1, 2026.