Current Market Trends
Procurement & Tenders
Population: 7.3 million
GDP: (2016 est.): $40 billion
Currency: Serbian dinar (RSD)
The Serbian government has committed to improving and modernizing the nationalized healthcare system, which is in desperate need of reform. In recent years, the Government has undertaken an extensive program of renovation, with the help of external financing from international organizations, such as the World Bank. Equipment upgrades are part of this goal.
The healthcare system in Serbia is financed by compulsory health insurance contributions, based on 10.3 percent of payroll taxes. The system provides easy access to comprehensive health services for the entire population. A majority of hospitals are public (state-owned). Owing to Serbia’s underdeveloped insurance market and state healthcare policy, the private sector share is minimal. The public healthcare network in Serbia includes a total of 344 healthcare institutions: 210 primary healthcare entities, 76 secondary level institutions (40 general hospitals and 36 special hospitals and rehabilitation centers), and 29 tertiary care institutions. The total number of beds in state hospitals stood at 38,200 at the end of 2014.
The Ministry of Health is the major decision maker in the Serbian healthcare market. It develops health policies and budgets, monitors the work of state-owned health institutions and approves plans for purchases of medical equipment. The Public Procurement Act requires open tenders for all purchases. Private medical practitioners present some opportunities for sales of dialysis and diagnostic imaging equipment.
The Medicines and Medical Devices Agency of Serbia (ALIMS) (www.alims.gov.rs) is in charge of issuing marketing authorizations for medicinal products and medical devices. Even though Serbia has adopted most of the European regulations, the CE mark has not yet been recognized, so medical products from EU have to pass the marketing authorization process. This procedure is more simplified from the one which products without CE mark have to undergo.
Most distributors handle several brands of similar equipment or several lines. Pricing is a key factor in selling a medical product in Serbia, as the market is very price sensitive. When purchasing medical equipment, end-users also look for established companies with reliable after-sales service and customer support.
Private medical practices developed in Serbia over the last ten years. Most of them were developed in Belgrade in cooperation with a successful pan-European medical service provider specializing in diagnostics investigations, clinical laboratories and cancer treatment services. Some examples are: Bel Medic, Euromedic, Medi-Group, Affidea, Vizin, etc. This segment of the market will be medium-term procurement in Serbia, while reconstruction of state-owned hospital will remain for the long-term plans.
o Linear accelerators
o cardiovascular diagnostic equipment
o non-invasive surgical devices
o anesthesia and intensive care equipment
o diagnostic imaging (CTs, MRIs)
o radiation therapy equipment
o ultrasound equipment
o urology equipment
o laboratory and testing equipment
o tissue and blood bank related equipment
o ultra-violet/infra-red equipment used in medical, surgical, dental, or veterinary sciences
o apparatuses based on the use of X-rays of alpha, beta or gamma radiation treatments
o Medical lasers
Local distributors indicate that there is a large demand for diagnostic tests for drugs, pregnancy, and various illnesses, and express interest in importing what they call “hit” products, i.e., new U.S. products with no European equivalents. Digitalization of various technology processes in hospitals and optimization of the IT systems and improvement of hospital management systems will be on the agenda in 2016.
Medium- and long-term procurement opportunities include the following: information systems (to be developed through the National Health Insurance Fund), training, public information and technical assistance, and support for outpatient and inpatient care. Hospitals routinely procure diagnostic equipment, modern patient monitoring systems, and hospital management systems.
The Ministry of Health is looking for innovative ways to work with medical equipment suppliers and is considering the creation of PPPs in which a company would equip and administer a certain medical center or hospital unit. This is in the conceptual stage, and the Ministry and the Health Insurance Fund are willing to listen to different proposals.
The market for natural medicines has expanded significantly in recent years. While U.S. suppliers should be able to offer a full range of food supplements, calcium citrate/ acetate/ lactate, iron sulfate, and glucosamine sulfate are in particular demand. There is significant demand for oncology products, vitamins/minerals, and natural medicines aimed at the prevention of diseases, as well as for drug/alcohol tests.
The Serbian Law on Drugs prohibits the sale of any pharmaceuticals, including OTC, outside of pharmacies. Customs-free access to some markets such as Russia, former-Yugoslav countries, and the EU provide many opportunities for both medicines and medical devices, such as export-oriented green-field investments, contract manufacturing and outsourced small-batch production. Serbia's leading pharmaceutical companies have modern technological solutions that comply with good manufacturing practice.
There are no restrictions on imports, provided the medicines are registered or approved for use in Serbia. The import duties range from 1.5-3%. Customs duties are not applied to the imports from the countries from the region that Serbia has signed Free Trade Agreements with. According to Serbian tax regulation, all products regardless of origin are subject to a 20 percent value added tax, which is borne by the final customer (hospital or patient), except orthotic and prosthetic devices and medical devices - products that are surgically implanted in the body, which are subject to a 8 percent value added tax.
Although Serbia has adopted most European regulations, the CE mark has not yet been recognized, so pharmaceutical products from the EU have to pass a Serbian marketing authorization process.
In January 2015, the National Health Insurance Fund (RFZO) announced that patients would have to pay full price for more than 120 drugs that had been fully or partially reimbursed. These drugs include antibiotics, sedatives, statins, anti-hypertensives, and drugs for other serious diseases. The move is aimed at slowing consumption of certain high-demand medicines.
In November 2016, The National Health Insurance Fund of the Republic of Serbia (RFZO) signed an agreed with 11 pharmaceutical companies, four of which are American, to include their innovative drugs on the state-subsidized drugs list. It is expected that in the following years more innovative drugs will be added to this list, which is a good opportunity for U.S. pharmaceutical companies doing business in Serbia.
Pricing and reimbursement policies in Serbia are regulated by two acts: Price Decree for Drugs for Human Use and the Decree on the Criteria and Procedure for the Reimbursement List. These decrees established the criteria for setting maximum prices for all medicines, whether reimbursed or not reimbursed/ purchased by state. The maximum wholesaler price permitted is set at an adjusted average of wholesaler prices in three reference countries, i.e. Slovenia, Croatia and Italy.
Based on the Law on Drugs and Medical Devices, guidelines for the PDL (positive drug list) for the reimbursement of drugs consists of products grouped under their anatomical-therapeutic-chemical (ATC) code. These products cover socially important and recognized groups of diseases and are selected on the basis of efficacy, safety and pharma-economic indicators (oncology, cardiovascular diseases, neurology, psychiatry, metabolic disorders, allergies and respiratory diseases). The PDL and all corresponding specific regulations for drug reimbursement are designed to decrease the share of original, innovative products whenever generics are available and to guarantee their reimbursement by public funds.
For four years, the Serbian State Insurance Fund (RFZO) did not add a single original, innovative product to the PDL. Some positive development in the Serbian marker regarding innovative drugs occurred in November 2016. RFZO signed agreement with 11 pharmaceutical companies, out of which 4 are American, on including their innovative drugs to the state-subsidized drugs list. It is expected that in the following years more innovative drugs will be added to this list, which is good opportunity for US pharmaceutical companies doing business in Serbia.
Procurement & Tenders
Name of event: International Fair of Medicine
English language website: http://www.sajam.co.rs
Description: International exhibition of medical, laboratory, dental, veterinary equipment and instruments, pharmaceutical and other equipment and medical services. The Accompanying Programme features up-to-date scientific and expert issues in different fields of medicine, laboratory diagnostics and dentistry.
U.S. Commercial Service Contact Information
Name: Zorica Mihajlovic
Position: Senior Commercial Specialist
Phone: +318 65 384 8990
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