More and more problems: Council of Ministers shifts responsibility from itself to the management of the Agency for Medicines

The president of the Trade Union of the Agency for Medicines and Medical Devices of Bosnia and Herzegovina, Ramo Hrustemović, once again warned in an interview with the Patria news agency that the director and deputy director of the Agency have not yet been appointed in accordance with legal regulations, writes the Patria news agency.

The Ministry of Civil Affairs of BiH, in accordance with the conclusion of the Council of Ministers of BiH of 06.11.2015, published a public advertisement for the selection and appointment of the director and deputy director of the Agency, conducted the selection procedure and determined the ranking lists of the best candidates by the Professional Council for the appointment of the director and deputy director of the Agency.

- Otherwise, the composition of the Professional Council has not changed since the establishment of the Agency in 2009 - a chronically technical mandate - says Hrustemović.

Drug control in Bosnia and Herzegovina has a tradition of almost fifty years. From the Service for Drug Control, in July 1992, the Center for Drug Control was formed, which was part of the Institute for Health Protection of Bosnia and Herzegovina. The Center performed laboratory testing of drugs and auxiliary medicinal substances, and maintained continuity during the war.

- After the signing of the Dayton Agreement, the need arose for Bosnia and Herzegovina, as a sovereign state, to have an official laboratory for drug control. By signing the Memorandum of Understanding between the European Commission and the Government of the Federation of BiH in 1998, the obligation was undertaken to form an institution that would work, under equal conditions, for both entities and which, until the formation of the Agency, was the federal institution, the Institute for Drug Control of the Federation of Bosnia and Herzegovina.

The control laboratory in Sarajevo is a member of the EDQM, the European Directorate for the Quality of Medicines and HealthCare, which exists at the level of the Council of Europe. The control laboratory within the Agency participates in the work of European regulatory bodies for medicines (European Directorate for the Quality of Medicines, Network of Official Laboratories for Quality Control of Medicines of the Council of Europe (OMCL) - explains Hrustemović.

The acting director of the Agency was appointed as acting director by the decision of the Council of Ministers of BiH dated 30.12.2015, and the Agency has not had a deputy director for the past six years.

The position of deputy director of the Agency in the first term and from the beginning of the Agency's work was held by the late Šeherzada Hadžidedić, who died in December 2012, and to this day, this position has not been filled, and according to the distribution, it belonged to Bosniak cadres.

- By not filling the deputy position of the representative from the Federation of BiH, we feel insufficient representation in decision-making on very important issues related to the work of the Control Laboratory, starting from the organization of the laboratory's work, the number and profile of staff, as well as the labor-legal and material status of all employees. The control laboratory in Sarajevo had 54 employees when it joined the Agency, and now it has 42 employees, and in the next two years, a smaller number of employees is expected, mainly due to retirement but also the departure of educated staff due to poor financial status and the inability to hire new staff.

It is announced from unofficial circles, at the level of the Council of Ministers of BiH, that the number of employees and their salaries will be reduced in all Institutions of Bosnia and Herzegovina. This would further affect the functioning and hinder the work of this expert Agency - says Hrustemović.

The registration of new medicines has been blocked in BiH since May this year because the Council of Ministers of BiH has not made a decision based on which the Agency would pay a monthly fee to the Commission for Medicines.

- The Council of Ministers of BiH shifts responsibility from itself to the management of the Agency, without entering into the legal merits of the matter that the Commission for Medicines did not work, therefore I ask the Council of Ministers to react just as urgently to the problem of not appointing the director and deputy director of the Agency, which has been missing for six years.

All state-level institutions (Council of Ministers, Presidency of BiH, Presidents of coalition parties) are aware of the problem of not appointing the director and deputy director of the Agency, especially the Ministry of Civil Affairs, which is responsible for the Agency - adds Hrustemović.