SERBIA Law and Practice Contributed by: Bisera Andrijašević and Anja Gligorević, BDK Advokati
as pharmacies, must align the prices of pharmaceuti- cals that they have in stock with the maximum prices determined by the government on the same day as the relevant decision on maximum prices enters into force. However, marketing authorisation-holders are free to determine the prices of over-the-counter medicines and must only notify the Ministry before March 1st of the current year of the price for the previous year. 8.2 Price Levels of Pharmaceuticals or Medical Devices The Ministry of Health calculates the maximum whole- sale price for prescription-only pharmaceuticals based on a number of criteria. One of these criteria is price parity – ie, the comparable wholesale prices of phar- maceuticals in reference countries, namely, Slovenia, Greece and Italy, and the current wholesale price in Serbia, in addition to other applicable criteria. 8.3 Reimbursement From Public Funds For the cost of a pharmaceutical to be reimbursed, 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 pharma- ceutical; • pharmaco-economic justification of the pharma- ceutical; 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 pharmaceuticals which comply with the general criteria, the National Health Insurance Fund further considers two special factors: (i) the existence, if any, of a managed entry agreement,
and (ii) the priority for adding the pharmaceutical to the list according to the following criteria: • the lack of a pharmaceutical from the same phar- maco-therapeutic group on the Positive List for a particular medical indication; • the significance of a pharmaceutical for public health; and • ethical aspects. 8.4 Cost-Benefit Analyses Within the scope of the process for inclusion of phar- maceuticals into the Positive List of pharmaceuticals to be reimbursed from the national health insurance, the Central Medicines Commission 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 regulated only with respect to prescription-only medicines. The ALIMS decides whether a medicine is to be dispensed only on prescription in a marketing authorisation pro- cedure. Prescriptions and dispensing of pharmaceuti- cals are regulated in the Rulebook on Form and Con- tent of Medical Prescription, Manner of Issuing and Prescription of Pharmaceuticals. Healthcare profes- sionals are obliged to observe the recommendations 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 phar- macist, and under the condition that the physician did not prohibit replacement on the prescription.
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