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Healthcare Resource Guide: Serbia

Serbia Statistics


Description: http://prezentacije.mup.gov.rs/upravapolicije/FOTO/zabava/Srbija-Drzavna_zastava_wp_1024.jpg

Summary

Market Entry

Current Market Trends

Main Competitors

Current Demand

Registration Process

Reimbursement

Procurement & Tenders

Trade Events

CS Contacts

Capital: Belgrade

Population: 7.3 million

GDP: (2016 est.): $40 billion

Currency: Serbian dinar (RSD)

Language: Serbian

Summary

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.

                                                             

Market Entry

 

  • Medical devices - The Serbian market is very receptive to high quality U.S medical equipment. It is highly competitive for its suppliers due to the concentrated size of the Serbian market and the number of diverse importers. In addition, the structure of the public healthcare sector and especially the bureaucratic process of the existing tender system make it imperative for U.S. suppliers to have local partners. Competitive strategies focus mostly on pricing, exchange rates, and payment terms, particularly when dealing with the public hospitals.

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.

  • Pharmaceuticals - Serbia’s overall pharmaceutical market is relatively underdeveloped, seeing regular medicine shortages and somewhat long waiting times for patients. The Serbian pharmaceutical market is split between domestic production and imports of pharmaceuticals from foreign multinationals. Presently, most multinationals are involved in the Serbian market through imports of their product portfolios or through licensing and marketing agreements with local players. Roche is one of the leading players on the market, with other multinational companies in Serbia including Merck, GlaxoSmithKline, Pfizer, Sanofi, Novo Nordisk, Abbot, Janssen-Cilag and AstraZeneca. About 70 foreign companies have representative offices in the country, with the majority being members of the Association of Foreign Pharmaceutical Manufacturers in Serbia. Roche remains the only foreign pharmaceutical player with affiliate status, and reportedly records the largest turnover among the international pharmaceutical players in the country.

Current Market Trends

  • Medical devices - In 2016, the Serbian market for medical equipment and supplies was estimated at $220 million, or USD 27 per capita. The market rose 4.5 percent compared to the previous year. Further growth of three to five percent annually between 2016 and 2020 is expected, reaching USD 300 million. Imports account for approximately 88 percent of the market, in part because of the implementation of health reforms that increased demand for new equipment. The leading medical equipment suppliers are EU-based manufacturers. Approximately 10 percent of medical equipment imports are from the United States, although the actual share of U.S. imports is higher as some is shipped from their European subsidiaries. Domestic production of medical equipment and devices is small and largely covers medical supplies such as bandages and syringes, as well as low-tech and small amounts of hi-tech medical equipment.

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.

  • Pharmaceuticals – The Serbian pharmaceutical market is one of larger markets in the Central and Eastern European (CEE) region, Serbia’s overall pharmaceutical market is relatively underdeveloped, seeing regular medicine shortages and somewhat long waiting times for patients. The total market for pharmaceutical products in Serbia was estimated at USD 1.051 billion in 2016, remaining at the 2015 level. Serbia's pharmaceutical market is dominated by prescription drug sales, which account for 89.70 percent of the total value of the market, primarily generic medicines, which in turn constitute 69.00 percent of prescription drug sales and 61.90 percent of the total value of the market. Over-the-counter (OTC) medicines are the smallest segment of the market, accounting for 10.28 percent of total pharmaceutical sales. Patented drugs are also a considerable segment of the pharmaceutical market, worth some 27.78 percent of the market in value terms. Serbia's Republic Health Insurance Fund 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.

Main Competitors

  • Medical Devices - The Serbian market is overall receptive to U.S. products. U.S. medical equipment enjoys a solid reputation in terms of quality and sophistication. American companies face stiff competition from Western European companies in Serbia. The biggest European competitors are Siemens and Philips. The proximity of the European firms to the Serbian market allows them frequent visits to meet end users, to participate in exhibitions and scientific meetings, and to provide prompt after-sales services to buyers.
  • Pharmaceuticals - The Serbian pharmaceutical market is split between domestic production and imports of pharmaceuticals from foreign multinationals, as the country is home to several, large generic drug makers, such as state-owned Galenika, Stada subsidiary Hemofarm and Actavis subsidiary Zdravlje.

Current Demand

  • Medical Devices - U.S.-manufactured medical equipment enjoys an excellent reputation in Serbia for its state-of-the-art technology, quality, and reliability. The best sales prospects for U.S. medical equipment include:

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

o Endoscopes

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.

  • Dental Equipment and Supplies - Serbia has dental practices and dentists that offer high quality dental services with affordable prices which has resulted in an increase of dental tourists. Serbian dental equipment and supply market is dominated by German, Scandinavian, Italian and French suppliers. However, it provides market potential for U.S. suppliers of teeth whitening systems, lasers, optical instruments, small equipment for implants and root canal treatment and orthodontics devices.
  • Pharmaceuticals - Serbia has some of the highest rates in Europe for cardiovascular disease, cancer, liver disease, and cirrhosis because of poor diets, high smoking rates, and other unhealthy habits. Pharmaceuticals that address these conditions, as well as their precursors (e.g., hypertension, high cholesterol, etc.) are in demand. In 2016, the highest demand was for cardiovascular drugs, followed by antibiotics and medications for the nervous system. The market for drugs and supplements is growing and local distributors are in constant search of new U.S. suppliers.

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.

Registration Process

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.

Reimbursement

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

Trade Events

Name of event: International Fair of Medicine

Location: Belgrade

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

Email:           Zorica.mihajlovic@trade.gov

Phone:          +318 65 384 8990


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