Expert Council of the Medicines Agency on Hold: Despite Warning, Minister Bošnjak Did Not Provide Candidate Names in the Proposal

(Patria) – The Council of Ministers of Bosnia and Herzegovina, at its session held on March 12, removed from the agenda for the second time a point concerning the appointment of members of the Expert Council of the Agency for Medicines and Medical Devices of Bosnia and Herzegovina. The Ministry of Civil Affairs of Bosnia and Herzegovina was tasked, by a conclusion of the Council of Ministers of Bosnia and Herzegovina from February 9, to prepare a draft decision and submit it for consideration.

The job of the Ministry of Civil Affairs is to collect proposals from the Ministry of Health of the Republika Srpska, the Federal Ministry of Health, and the Department of Health of the Brčko District. The mandate of the previous Expert Council expired in March 2022, and during 2023, the Ministry of Civil Affairs received candidate proposals.

The Ministry of Health and Social Welfare of the Republika Srpska submitted its proposal on March 7, 2023, the Government of the Brčko District on May 24, and the Federal Ministry of Health on October 31, 2023.

The Ministry of Civil Affairs of Bosnia and Herzegovina requested an opinion from the Office for Legislation, which stated in its opinion that the names of the members of the Expert Council must be listed in the Draft Decision. The General Secretariat of the Council of Ministers of Bosnia and Herzegovina held the same position, informing the Ministry of Civil Affairs in January 2024 to submit a proposal of candidates for members of the Expert Council.

At the helm of the Ministry of Civil Affairs of Bosnia and Herzegovina is HDZ cadre Dubravka Bošnjak. And at the helm of the Federal Ministry of Health is HDZ 1990 cadre Nediljko Rimac, and she does not like the proposal he submitted. For this reason, Minister Bošnjak is dragging out the procedure, even though the mandate of the previous Expert Council expired two years ago.

Rimac proposed three names: Zoran Šantić, Ivan Ćosić, and Nedim Hrelja. Minister Alen Šeranić proposed Jelena Medar, Zorana Sučević, and Nikola Dronjak. From the Brčko District, Daut Hadžić was proposed.

The Expert Council is the professional, regulatory, advisory, and supervisory body of the Agency for Medicines and Medical Devices of Bosnia and Herzegovina, and it consists of three representatives each from the entities of the Federation of Bosnia and Herzegovina and the Republika Srpska, and one from the Brčko District.

Article 16 of the same law lists the tasks and competencies of the Expert Council, which are: establishing proposals for the policy on medicines and medical devices throughout Bosnia and Herzegovina, adopted by the Council of Ministers of Bosnia and Herzegovina; considering and directing the implementation of guidelines from authorized ministries on the policy of medicines and medical devices; defining the strategic goals of the Agency and evaluating the Agency's performance in achieving these goals; providing opinions on the Rulebook on Internal Organization and Job Classification of the Agency, adopted by the Agency Director with the consent of the Council of Ministers of Bosnia and Herzegovina; adopting by-laws based on this Law, upon the proposal of the Agency Director; establishing and harmonizing good practices upon the proposal of the Agency Director; establishing proposals for general and other acts of the Agency based on the Law; approving the annual work plan of the Agency and the annual financial plan of the Agency upon the proposal of the Agency Director; considering and adopting the annual report on work and operations, as well as the final account of the Agency; supervising the entire work and operations of the Agency, including the content, scope, and quality of implementation of the annual plan, and the compliance of the annual report with the business plan; supervising the implementation of the Law and by-laws adopted based on the Law; and performing other tasks determined by the Law and regulations adopted based on the Law.

In addition to the above, the Expert Council may propose the adoption or amendments to legal regulations in the field of medicines and medical devices if it deems it necessary for the implementation of this Law, as well as regulations adopted based on this Law. The Expert Council, upon the proposal of the Agency Director, adopts instructions by which prescribed data or documents, used in the work of the Expert Council and the Agency, will be considered official secrets in accordance with regulations on freedom of access to information in Bosnia and Herzegovina and the entities.

The General Secretariat requested that candidate names be submitted