Healthcare Resource Guide: Croatia

Croatia Statistics

Summary
Market Entry

Current Market Trends

Main Competitors

Current Demand

Registration Process

Reimbursement
Barriers

Trade Events

CS Contact

Best Prospects

Market Size

Capital: Zagreb

Population: 4.238 Million

GDP*: $57.11 (2014 *Market prices)

Currency: Croatian Kuna

Language: Croatian

Summary

Croatia spent an estimated 7.91% of GDP on healthcare in 2016, equal to $3.85 billion, or $910 per capita. This is high compared to the neighboring countries, but remains considerably below Western European countries. 82.2% of this spending was in the public sector ($3.16 billion) and 17.84% in the private sector ($686 million).

The Croatian government is currently undertaking an extensive reform of the healthcare sector to increase its efficiency and limit spending to more affordable levels. Nevertheless, Business Monitor International forecasts healthcare expenditures to growth by 0.5% in US dollar terms, reaching $3.95 billion by 2020. Private sector expenditure is expected to grow at a rate of 3.1% by 2021.

Croatia is a member of the European Union, and it has fully implemented the new EU Medical Device Regulation.

Market Entry

Medical equipment products exported to Croatia must comply with the following requirements:

  • CE Certification
  • Directions for use accompanying the products must be in Croatian language.

The EU common Customs Tariff schedule applies to products exported from non-EU countries. All products, regardless of origin, are subject to the value-added tax (VAT). For medical products embedded in the body by surgical procedure, and medical products substituting physical abilities, the VAT is 5%, and for all other medical products, it is 25%.

The institutions responsible for regulatory monitoring of market entry rules and laws are the Ministry of Health (www.zdravlje.hr), the Agency for Medicinal Products and Medical Devices (www.almp.hr), the Agency for Quality and Accreditation in Health Care and Social Welfare (www.aaz.hr), and the Croatian Institute for Health Insurance (www.hzzo-net.hr).

The appointment of a local distributor or the establishment of a representative office is essential to navigate the tendering process and reach end-users throughout the country. Some of the leading local distributors are Medika (www.medika.hr), Medical Intertrade (www.inel-mt.hr), and Phoenix Farmacija (www.phoenix-farmacija.hr).

Current Market Trends

Funding for healthcare in Croatia is done principally through the compulsory health insurance system which is operated by the Croatian Health Insurance Fund (HZZO). The HZZO collects contributions from the working population and the government makes payments on behalf of those exempt, such as the elderly, the unemployed and dependents. The $3.65 billion budget of the HZZO provides treatment for approximately 4.33 million insured persons annually. An ageing population, with 19.3% of people older than 65 years of age, presents challenges for the limited healthcare budget.

In 2016, the Croatian market for medical equipment and supplies was estimated at $290.8 million, or $68.8 per capita, primarily government funded. It is expected that the market will expand at a rate of 8.9% per annum in US dollar terms, reaching $329.4 million by 2018. The largest product area within the market was consumables, accounting for 24% of the overall total, followed by patient aids, dental products, and orthopedics. Consumables are also a fast growing area with an estimated 10.5% growth rate by 2020.

Around 90% of the medical device market is supplied by imports. Croatia’s imports of medical devices totaled about $245.4 million in 2015; this represents an increase of 7.3% in US dollar currency compared to 2014. Most of the imports come from Germany, Belgium and China, while the United States ranks 12th. Croatia has a small domestic production sector, supplying both the domestic market and other countries of the former Yugoslavia. In 2015, exports grew 33.5%, reaching $37.5 million.

Pharmaceutical expenditures in Croatia accounted for 25.5% of healthcare expenditure or 2.02% of GDP in 2016. Total drug expenditures in Croatia in 2016 were around $980 million, which represented a 13.4% increase in US dollar terms after sharp decline in 2014 and 2015. Croatia’s pharmaceutical expenditure per capita is $232, the seventh highest per capita expenditure in the Central and Eastern Europe Region (CEE). Prescription drugs accounted for 92.6% of all pharmaceutical sales.

The Croatian pharmaceutical market is highly competitive, with market share distributed among a large group of multinational and domestic companies. The domestic drug industry currently meets 35% of local demand in terms of value and 50% in terms of volume. The value of imported pharmaceuticals reached $904 million in 2016, with projected marginal growth. Croatia exported $712 million worth pharmaceuticals in the same year.

Main Competitors

Croatia has a small domestic production sector, and there is very little multinational manufacturing activity.

Around 92% of the medical device market is supplied by imports. Market leaders are European and U.S. manufacturers, namely General Electric, Johnson & Johnson, 3M, Bauerfeind, Astra, Drager, etc. Some of these companies have established their own local subsidiaries, while most companies will use third party distributors to supply the market.

Current Demand

The National Healthcare Development Strategy 2012-2020, developed by the Croatian Ministry of Health, will expand health-related IT systems in the country and restructure the hospital sector.

Improving the quality of healthcare and the efficiency of public health services in Croatia has been a government priority for the past three years. In May 2014, the World Bank approved a $103.5 million project to improve the healthcare delivery system, rationalize the hospital network, strengthen the government's capacity to develop and monitor effective health sector policies, and promote effective public health. The project’s expected completion date is June 2018. In February 2017, the European Regional Development Fund allocated $77.3 million to upgrade infrastructure and the procurement of medical devices at 12 Croatian hospitals. Further contracts worth $90.2 million will be signed in 2017 to upgrade additional hospitals and improve access to primary and emergency healthcare. In addition to these improvements to the existing hospitals, construction of new hospitals in Pula, Rijeka and Bjelovar are planned for 2017-2018.

The size of the private healthcare sector is expanding in Croatia, but the greatest increases have occurred in the number of general practitioners’ offices, which do not require as much high-tech equipment as large hospitals. Private clinics and medical practitioners account for approximately 10% of total services provided in the health sector.

The health and dental tourism sector is growing in Croatia, presenting high potential to boost high-quality medical equipment and pharmaceutical sales.

The Croatian pharmaceuticals market is dominated by generic products more so than most other markets in the CEE region due to the relatively small number of patented products available for reimbursement. As Croatia's laws and regulations align with the EU norms, the over-the-counter (OTC) medicine sector is being liberalized, which will contribute to a rebalancing of the domestic pharmaceutical market and the switching of categories from prescription-status to OTC.

Approximately 25% of all drug expenditures are attributed to various groups of cardiovascular drugs. The second highest ranked group is nervous system drugs, followed by immune system/cancer treatment drugs and gastro-intestinal drugs.

Croatian pharmaceuticals distributors are interested in the possibility of representing additional U.S. principals and/or use the manufacturing capacities of U.S. private label manufacturers. Food supplements and over-the-counter pharmaceuticals represent other areas where Croatian distributors are looking for new brands.

Registration Process

The Agency for Medicinal Products and Medical Devices (HALMED) is responsible for placing medical equipment on the Medical Devices and Homeopathic Products Register. All applications submitted to HALMED proceed in accordance with EU legislation. To register a medical device, manufacturers must submit a written application to HALMED, accompanied by extensive documentation.

More information on registration process is available at www.almp.hr.

Reimbursement

HZZO oversees pricing and reimbursement within the healthcare sector. Croatia uses the Australian Refined Diagnostic Related Groups (AR-DRG) system for healthcare services, which includes over 650 diagnoses. Pharmaceuticals are reimbursed through basic or supplementary list. Pharmaceuticals on the supplementary list require sub-payments by the patients and are usually more expensive. Payments to the suppliers are significantly delayed (over 200 days), creating large burden for manufacturers and wholesalers.

The HZZO plans to introduce performance-based payment for primary care, introduce diagnosis-related groups in hospitals, and create one pharmaceuticals’ list where all drugs would require patients only to pay a value-added tax (VAT) of 5% per prescription.

Barriers

Companies exporting medical equipment to Croatia will not encounter any direct trade barriers or quotas. Non-tariff, indirect trade barriers could include the complex system of approval for government reimbursement list or inefficiency of the health-care system causing long delays in payments to the suppliers.

Procurement & Tenders

In 2012, the government introduced a joint hospital procurement program for public hospitals to eliminate huge variations in the prices that different hospitals paid for identical products. A decentralized approach was adopted, where nine state-owned hospitals and the HZZO were declared as the procurement coordinators and each was assigned a range of products that they would purchase for all participating hospitals. Hospitals that had historically achieved the best value for money for a particular category of products became the central purchaser/coordinator for that line of products. The system is only used for purchasing items that account for the largest share of hospitals expenditures, such as medical devices, pharmaceuticals and energy.

Trade Events

Dentex, dental trade show, Zagreb, Maz 19-21, 2018

Web site: http://www.zv.hr/default.aspx?id=1197

Government Links:

Healthcare Procurement:

https://eojn.nn.hr/Oglasnik/

Government Health Plans:

https://zdravlje.gov.hr/pristup-informacijama/javna-nabava-1473/plan-nabave/2851


U.S. Commercial Service Contact Information

Name: Nina Radicevic

Position: Commercial Assistant

Email: nina.radicevic@trade.gov

Phone: +385 1 6612090

Best Prospects

  • Consumables
  • Dental products
  • Orthopedics

Market Size

Healthcare spending (including investment)

3.94 billion (USD)

... as percent of GDP

7.8%

... of which spent on pharmaceuticals/consumables

25.5%

Hospitals, Procedures, Healthcare Professionals UN:

Number of hospitals

90

…Public

77

…Private

13

Number of hospital beds

25,563

… available beds per capita

6,446

Number of surgical procedures

215.99/1,000

Physicians

14,848

…of which surgeons

2,708

...of which internists

4,838

…of which pediatricians

798

Dentists

3,850

Demographics

Population

4,313,707

Life expectancy men/women

Female: 79.2 years; Male: 72.7; Total: 75.9

Infant mortality

F: 9.8/1000; M: 9.2; Total: 9.5/1000

Percent of population older than 65

18.8%

...projection, 2030

.96mn people; (~23.09%)

Annual deaths

12.1/1000

...caused by [highest disease burden]

cardiovascular disease

...caused by [second highest]

cancer

Prevalence of [fastest growing disease burden]

Non-communicable diseases- cancer


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