The Bulgarian Health Minister participates in a debate on critical medicines and the reform of the EU pharmaceutical legislation.

The Minister of Health of Bulgaria, Assoc. Prof. Dr. Silvi Kirillov, participated in the regular meeting of the EU Council on Health (EPSCO) in Luxembourg. The main topic of the discussion was the legislative proposal for the Critical Medicines Act. Despite the general support, concerns were expressed regarding the requirements in the field of public procurement, which can excessively burden health budgets. The comments addressed both national public procurement and the criteria for the most economically advantageous tender (MEAT), as well as the proposed joint EU tendering procedures.

Several Member States called for taking into account the different specificities and capabilities of the countries, as well as for consideration of the division of powers between the EU and national authorities. A significant number of statements emphasized the need for European financing. Bulgaria expressed principled support for the proposal, while at the same time stressing the need to respect the principles of subsidiarity and proportionality, while respecting the powers of the Member States for the organization and financing of healthcare.

The ministers expressed support for the balanced Council mandate for negotiations with the European Parliament on the legislative proposal for the reform of the EU pharmaceutical legislation (the so-called "Pharmaceutical Package"). They highly appreciated the progress in the negotiation process and expected the Council's mandate to be defended in the upcoming tripartite negotiations.

Minister Kirillov expressed gratitude for the good cooperation with the Polish Presidency, supported the achieved balanced compromise, and recalled that Bulgaria's expectations were also stated in a declaration upon the adoption of the general approach. The Council Presidencies (Poland and Denmark) and the European Commission expressed readiness for intensive work to complete the negotiations on the two legislative proposals by the end of 2025.

The ministers also approved Council Conclusions on promoting and protecting the mental health of children and young people in the era of digital technologies. In the discussion on measures to prevent and limit smoking and alcohol, Minister Kirillov emphasized the need for a clear focus on protecting young people and limiting new forms of nicotine addiction. However, Bulgaria highlighted the need for the subsequent revision of legislation in this area to be based on a full impact assessment and scientific data.

Bulgaria also took a position on the item "Other Business" included in the agenda, regarding the impact of the extended producer responsibility on the supply of medicinal products. The official note submitted calls on the European Commission to further assess the impact based on accurate data and to revise the obligations and deadlines.

During the working lunch, the ministers exchanged views on the topic of "Cybersecurity of healthcare facilities". The Bulgarian Health Minister also held bilateral talks with his counterparts from Germany, Portugal, and Belgium.