SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds For the cost of a pharmaceutical to be reim- bursed, the product must be included in the Positive List. The general criteria for adding a pharmaceutical to the List are, as follows: • pharmaco-therapeutic justification of the pharmaceutical; • pharmaco-economic justification of the phar- maceutical; and • financial resources provided by the annual financial plan of the National Health Insurance Fund. In cases when there are not sufficient resources to include in the Positive List all pharmaceuti- cals which comply with the general criteria, the National Health Insurance Fund further consid- ers two special factors: (i) the existence, if any, of a managed entry agreement, and (ii) the priority for adding the pharmaceutical to the list accord- ing to the following criteria: • the lack of a pharmaceutical from the same pharmaco-therapeutic group on the Positive List for a particular medical indication; • the significance of a pharmaceutical for pub- lic health; and • ethical aspects.
8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices Within the scope of the process for inclusion of pharmaceuticals into the Positive List of phar- maceuticals to be reimbursed from the national health insurance, the Central Medicines Com- mission established by the National Health Insurance Fund conducts the health technology assessment of medicines when reviewing the applications for inclusion of pharmaceuticals on the List. 8.5 Regulation of Prescriptions and Dispensing by Pharmacies Dispensing and sale of pharmaceuticals is reg- ulated only with respect to prescription-only medicines. The ALIMS decides whether a medi- cine is to be dispensed only on prescription in a marketing authorisation procedure. Prescrip- tions and dispensing of pharmaceuticals are regulated in the Rulebook on Form and Content of Medical Prescription, Manner of Issuing and Prescription of Pharmaceuticals. Healthcare professionals are obliged to observe the recom- mendations from Good Practice in Prescribing of Pharmaceuticals. A pharmacy may replace the prescribed brand- name medicine with its generic equivalent only if the patient consents after being adequately informed by the pharmacist, and under the con- dition that the physician did not prohibit replace- ment on the prescription.
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