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: 7.1 million (without Kosovo)

GDP: $39.37 billion (2017 est.)

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% of payroll taxes. The system provides easy access to comprehensive health services for the entire population. Despite that, 38% of expenditure for healthcare services in Serbia are paid out of pocket. A majority of hospitals are public (state-owned). However, with the development of a private insurance market, private healthcare services and institutions experienced significant growth for the last ten years. The public healthcare network in Serbia includes a total of 355 healthcare institutions, including 158 primary healthcare entities, 75 secondary level institutions (41 general hospitals and 36 special hospitals and rehabilitation centers), 4 clinical centers and 4 military healthcare institutions. The total number of beds in state hospitals stood at 41,788 at the end of 2016. According to the official statistics, 10% of the total number of medical practicioners are working in the private sector.

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.

According to the new Law on Medical Devices, effective as of December 2018, CE mark will be recognized, while other products have to pass the marketing authorization process by ALIMS. Even though Serbia has adopted most of the European regulations, the CE mark has not yet been recognized for innovative pharmaceutical products. All drugs have to pass the marketing authorization process. This procedure is more simplified.

U.S. medical devices and pharmaceutical products have an excellent reputation and a strong market position in Serbia. Best prospects are products and medications for cardiovascular treatments, bone health, orthopedics, cancer treatments, dementia care, and cheaper and more efficient screening and diagnostic technologies, etc.).

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. As of December 2018, CE mark will be fully recognized and procedure for the imports will be significantly reduced. 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.

The appointment of a local distributor will be essential to navigate the tendering processes, both for medical devices and pharmaceuticals, and reach end-users throughout the country.

Current Market Trends

Current market trends reflect increasing life expectancy (74.6 years) and unhealthy lifestyles (obesity and heart disease are on the rise) in Serbia. Devices used to monitor symptoms and manage disease are in increasing demand. The most common cause of death is circulatory system problems (heart disease, stroke etc.). Serbs continue to be heavy smokers and the air in many industrial cities is somewhat polluted. Growing interest in innovative diagnostics devices and biological treatments could generate new opportunities for U.S. medical equipment providers, as well as pharmaceutical.

E-health has been a main topic in Serbia for the last five years. The Serbian Ministry of Health introduced basic concept through e-appointments and e-prescription, which should help to establish a program for the national introduction of eHealth in the future. The introduction of eHealth faces challenges including the low motivation of doctors, patient and, state institutions, limited legislation in this area and a lack of financing.

Main Competitors

  • Medical Devices: 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 high-tech medical equipment. The majority of medical devices used in Serbia are imported. Around 90% of the medical device market is supplied by imports mainly from the U.S. and European Union countries. 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. Competition from Chinese companies should be considered as a serious challenge for the future market entry strategies.
  • 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: Stada subsidiary Hemofarm and Actavis subsidiary Zdravlje. Local Galenika was recently privatized and sold to new owner from Brazil (EMS S.A).

Current Demand

  • Medical Devices: In 2017, the Serbian market for medical equipment and supplies was estimated at $220 million, or USD 27 per capita. The market rose 4.0% compared to the previous year. Further growth of three to five% annually between 2016 and 2020 is expected, reaching USD 300 million. Imports account for approximately 88% of the market, in part because of the implementation of health reforms that increased demand for new equipment. Approximately 10% 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. Chinese companies have become very active in the Serbian market, leading to one of them to be in charge of providing medical equipment to the newly renovated Clinical Center Nis. Private medical practices have 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. According to the Association of private healthcare services providers, half of diagnostics equipment, such as MRs and scanners, are in private sector. 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. 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

  • Pharmaceuticals - 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 1.1 billion in 2017, recording small growth compared to 2016 levels. Serbia's pharmaceutical market is dominated by prescription drug sales, which account for 89.70% of the total value of the market, primarily generic medicines, which in turn constitute 69.00% of prescription drug sales and 61.90% of the total value of the market. Over-the-counter (OTC) medicines are the smallest segment of the market, accounting for 10.28% of total pharmaceutical sales. Patented drugs are also a considerable segment of the pharmaceutical market, worth some 27.78% 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. 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.
  • 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.
  • OTC: 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

Medicines and Medical Devices Agency of Serbia (ALIMS) is in charge of issuing marketing authorizations for medicinal products and medical devices. Although Serbia is not yet EU member, it has adopted most European regulations. For medical devices, EU certificate and approval will be mandatory as of December 2018, Medical Devices Law (2017). The registration process for pharmaceuticals is more complicated and time consuming (ALIMS).

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.

Barriers

There are no restrictions on imports, provided the medicines are registered or approved for use in Serbia. The import duties range from 1-5%. 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% 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 an 8% value added tax.

Procurement & Tenders

Trade Events

Name of event: Medident

Location: Belgrade

Date: October 11 – 13, 2018

English language website: www.sajam.rs/en/calendar-2018/medident/

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

Best Prospects

  • Medical devices: There are opportunities in the Serbian market for U.S. manufacturers of sophisticated diagnostic equipment such as imaging equipment, especially ultrasonic diagnostic equipment, MRIs, scanners and endoscopes. Pacemakers, nuclear medical instruments, and clinical laboratory equipment, as well as health informatics equipment, home healthcare and rehabilitation equipment and patient monitoring systems including intensive care units, are expected to become good opportunities for U.S. companies in the next few years.

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.

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.

  • Pharmaceuticals: 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.

Statistics Snapshot

Market Size

... as percent of GDP

10.4% (2014)

Hospitals, Procedures, Healthcare Professionals UN:

Number of hospitals

 

…Public

127

Number of hospital beds

41.788 (2016)

... available beds per capita

5.9 beds per 1.000 population (2016)

...of which in general hospitals

33.346 (2016)

...of which in specialized clinics and rehabilitation centers

8.442 (2016)

Physicians

20.054 (2016)

Dentists

1775 (2016)

Demographics

Population

7,111,024 (2017)

Life expectancy men/women

72.8 years / 78.8 years (2017)

Infant mortality

5.8 deaths/1,000 live births (2017)

Percent of population older than 65

18.43% (2017)

...projection, 2030

 

Annual deaths

13.6 deaths/1,000 population (2017)

...caused by

Neoplasms

...caused by

Diseases of the circulatory system

Prevalence of

Neoplasms


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