Serbia – New Perspectives for Pharmaceuticals and Medical Devices

With Serbia making further progress with the EU accession process and the prospect of joining the EU in 2025, it is the country which gets increased attention of international pharmaceutical and medical device manufacturers.

“It is the process of joining the European Union that counts and not so much the date that Serbia joins – Sanja Ivanic, CCFS

Home to 7.1mn people, Serbia spends 10.4% of GDP on healthcare.  The pharmaceutical market is valued by industry experts at EUR0.6bn. While the market is small in absolute terms, relative per capita spending on medicines is expected to improve over the long term.  Generic products account for 48 percent of the market in value terms and 78 percent by volume.  The share of generic medicinal products has been steadily declining over the last five years with some innovative medicines entering the market albeit on a much smaller scale compared to other CEE countries such as Bulgaria, Romania, Croatia and Slovenia.

Serbia’s pharmaceutical market is dominated by prescription drug sales accounting for circa 88% of the sector. The share of over-the-counter medicines is insignificant, representing 12 percent of the total pharmaceutical sales. Serbia’s National Health Insurance Fund (NHIF) provides full and partial reimbursement to insured citizens for pharmaceuticals placed on its positive reimbursement list. Currently, the reimbursement list consists primarily of generic drugs and the market segmentation reflects this.

Following a five-year period of stagnation as far as introduction of innovative medicines to the reimbursement list of the NHIF is concerned, in 2016 23 innovative pharmaceutical products were included on the list.

“The Serbian government took a very important step last year when they unblocked reimbursement for oncology products as one of the four priority therapeutic areas – Predrag Bogavac, Novartis

New introductions to the list are expected in 2018 and in the upcoming years.   Whilst Serbia is still noticeably lagging behind its regional counterparts, the international pharmaceutical manufacturers are optimistic.  They anticipate more regular and continuous introduction of new medicinal products alongside innovative therapies and their approval for the reimbursement list as is the case with many neighbouring CEE countries.  The recent announcement that the state aims to have all the drugs from the essential list of the World Health Organisation included on the reimbursement list by 2020 underpins the optimism among all pharmaceutical and healthcare industry players.

The regulatory environment in Serbia which was earlier considered to be unconducive to the introduction of innovative pharmaceutical products is now on the path of change underpinned by support of the European Union.  The EU has invested in drafting the legal framework for the pharmaceutical industry.  Gradual alignment of national registration procedures and standards is taking place and National Medicines and Medical Devices Agency of Serbia sets the right example in country’s EU integration process.  Further talks are held with EU experts in order to fully harmonise Serbian legislation for medicinal products and medical devices with the European laws.

For further information, please contact Jane Smith at Grove Group Pharmaservices  or visit our website