The prices of medicines that are not on the basic and supplementary lists, and which citizens pay out of pocket with a doctor's prescription, should be capped from March this year.
From mid-October to mid-December, 460 requests were submitted to the Institute for Medicines and Medical Devices to determine maximum prices for these medicines.
When asked how many medicines from this group the drug license holders have not submitted applications for and whether this means they will be withdrawn from the market, the Institute said that it is not possible to give a precise estimate at this time.
"At this point, it is not possible to give a precise assessment of whether applications have been submitted for all medicines, given that the Institute does not yet have data on the circulation of medicines for 2025. Given that the calendar year has just ended, it is expected that data on the circulation of medicines will be available in the middle of the current year," the response reads.
They explained that they are currently carrying out activities related to determining maximum drug prices in accordance with the Regulation adopted by the Government at the proposal of the Ministry of Health.
"The next steps in the process of setting maximum drug prices are the annual adjustment that begins in the first week of February," the response states.
The institute has 90 days, ending in mid-March, to determine the maximum price of the drug, which includes a wholesale margin of six percent excluding VAT. After the maximum price is established, a margin of 18 percent plus VAT is added in pharmacies.
The reference countries whose drug prices will be used for comparison with wholesale drug prices in Montenegro are the same as for therapy from the positive, basic and co-payment lists in accordance with the Regulation - neighboring Serbia, Romania and the Czech Republic.
Although the results of previous analyses by the Ministry of Health, "Montefarma" and the Institute indicated that this restriction will cover around 200 prescription drugs that are not on the list covered by the state, it is certain that the number of such drugs is much higher.
The Regulation on Amendments to the Regulation on Criteria for Establishing Maximum Prices for Medicines was adopted at the end of October last year, half a year after the adoption of the new Law on Medicines. The new Law on Medicines also provides for the establishment of maximum prices for medicines that are purchased with a prescription but are not on the basic and supplementary lists.
The Ministry of Health claims that the Government decided to take this step in order to stop the uncontrolled rise in drug prices and increase their availability for all patients.
Data from the Statistical Office (Monstat), measured by the Harmonized Index of Consumer Prices (HICP), which is fully comparable to the method of calculating inflation in Europe according to the Eurostat methodology, showed that the price of pharmaceutical products in Montenegro increased by 14,5 percent from July 2024 to July 2025.
In the same period, the price of medicines increased by 2,1 percent in EU member states and by 1,6 percent in eurozone members. In Montenegro, they increased at a rate almost three times higher than the increase in the EU member state with the highest price increase - Italy, at 5,9 percent.
Six countries saw a drop in pharmaceutical prices: Slovakia by 1,8 percent, France by 1,5 percent, Switzerland by 1,2 percent, Spain by 0,3 percent, and Iceland by 0,1 percent. Other countries saw a symbolic increase in drug prices - the Czech Republic by 0,1 percent, Belgium by 0,4 percent, Luxembourg by 0,7 percent, Finland by 0,9 percent, and Germany by 1,4 percent...
"Vijesti"'s interlocutors from the pharmaceutical sector previously pointed out that among the most important drugs from the so-called negative list, as well as the best-selling Andol (metamizole sodium), which has no direct parallel on the positive list, are chloramphenicol ointment, caffeine tablets, betaserc, aspirin, cardiopyrin, Andol, detralex, preductal, bilive, beloderm ointment, didermal ointment, certain nose drops...
Pharmacies do not look favorably on limiting the prices of drugs from the negative list and claim that this move, although at first glance it sounds like a consumer protection measure, in practice it can have several negative consequences. Among them are reduced availability and choice of therapy, potential distortion of market competition because the negative list implies that the market should only regulate prices through competition, thus making free price formation meaningless and discouraging new market entries.
There is also a fear in the pharmaceutical sector that companies that know they cannot market the drug at an economically sustainable price will simply not offer the drug in Montenegro, which may affect patients, and interlocutors claim that such a policy may also encourage a gray market.
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