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On 2 July 2019 the Cabinet of Ministers approved the changes in the bylaws of the National Health Service and the State Agency of Medicines, thus finalizing reallocation of duties between these institutions. This is part of an efficiency drive commenced by the Ministry of Health in 2018.
As a result, the following functions are transferred from the National Health Service (NHS) to the State Agency of Medicines (SAM): (i) economic assessment of medical technologies (i.e. methods to be applied in medical treatment, medical devices and medicines) reimbursed from public funds, (ii) approval and registration of the medical technologies used in medical treatment, (iii) maintenance of the respective registers. Until now the assessment of cost effectiveness of the medicines, medical devices and medical technologies used in medical treatment was one of the tasks carried out by the NHS when approving medicines and devices for reimbursement. The NHS will henceforth focus on “planning, administration and monitoring” of the public health funds, and on maintaining the IT infrastructure of public healthcare.
The Ministry of Health expects that the total time of reimbursement approvals will not increase. However, it must be noted that the administrative burden on the applicant will become more onerous. Instead of one-stop agency a person will further on be required to first obtain an assessment on the pharma-economic effectiveness of a product from the SAM and after that to submit another application to the NHS on inclusion of the product in the Reimbursable List.
The Regulation, which establishes the procedure for reimbursement approvals, is yet to be amended respectively.
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