Executive Summary
Market Entry
Current Market Trends
Best Prospects
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement & Tenders
Frequently Asked Questions
U.S. Commercial Service Contact Information
Tab Options
Executive Summary
Market Entry
Current Market Trends
Best Prospects
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement & Tenders
Frequently Asked Questions
U.S. Commercial Service Contact Information
Executive Summary
Slovakia is compliant with international requirements for approvals as well as intellectual property protection. The country has a tradition of medical device manufacturing, but it is increasingly difficult for domestic production to compete with western quality and innovative imports. Slovak State hospitals have constantly generated debts. Professionals repeatedly call for a system change whereby by hospitals either become stock or holding management companies, or through the introduction of independent authorities and external audits. According to a Health Consumer Powerhouse study based on World Health Organization (WHO) and Organization for Economic Co-operation and Development (OECD) data, Slovakia has been criticized for missing fully applied e-Health, problems with availability of planned surgeries, long waiting times for treatment, insufficient decline in deaths caused by cardiovascular diseases and stroke, many lost years (number of life years people could gain with better healthcare), and frequent staphylococcus occurrences in hospitals. Local professionals criticize the insufficiently low planned expenditures, reduction in payments for State policyholders by $271.4 million USD, and insufficient salary increases. Healthcare sector will have $7.4 billion (€6.3 billion) at its disposal, which represents a year-on-year increase of $485 million USD. More money is needed for co-payments for selected groups of the population, innovative treatment, and for the completion of medical procedures that could not be carried out during the pandemic. Additional reserve of $846 million USD should cover measures to mitigate the impact of the pandemic in various areas, such as financial support to entrepreneurs or buying vaccines. The sector’s growing debt of $946 million USD (€801.58 million in 2021) remains the sector’s biggest problem.
Market Entry
Slovakia is one of the more developed health device and pharmaceutical markets in the Central and Eastern European region. Eurozone membership has made trade with Slovakia easier by providing more transparent pricing and greater currency stability. A foreign producer that would like to export medical devices into Slovakia must first establish a contract with a local importer, which can help the company fulfill regulations such as the CE mark, Declaration of Conformity, translation of directions and manuals into Slovak, and a guarantee that the product has been approved by the Ministry of Health. Medical devices and pharmaceuticals are subject to a customs duty and value added tax (VAT) of 20%. Some products carry a 10% VAT.
Current Market Trends
Since 2008, several reforms were introduced to control cost and improve healthcare efficiency, including price referencing of healthcare materials, reduction of acute beds in hospitals, and centralized procurement. Based on OECD data, Slovakia’s healthcare spending stands at $2,360 USD (2020) 2,290 per capita which is comparable to Hungary ( $2,170 USD in 2019) and Poland ( $2,547 USD in 2020), as opposed to the Czech Republic ( $3,804 USD in 2020) and the United States ($10,948 USD in 2019).
Healthcare is publicly available and considered “free”. Despite having some of the cheapest drug prices in the European Union (EU), Slovakia’s spending on drugs is among the highest in the EU.
Slovakia has many hospitals that are poorly equipped and are intended to carry out all medical procedures. The Slovak Ministry of Health, based on future constitutional law amendments, plans to conduct stratification of hospitals, which will reduce the current 78 hospitals to 46 by 2030. The reform will secure 46 hospitals with an insurance company contract as a minimum hospital network improving healthcare accessibility. Hospitals will be divided into three categories – local (32-minute radius), regional (60-minute radius) and national (120-minute radius), differing from one another by specialization, accessibility, and quantity of treatments. Hospitals losing their status based on failing the complexity, accessibility, and quality criteria will be transformed into healthcare facilities.
In 2021, Slovakia had a healthcare debt of $950.5 million USD (€805.58 million) with a $159.2 million USD year on year increase is generated mostly by 13 State owned university and teaching hospitals. Overdue liabilities grew at an average monthly rate of $9.97 million USD in 2021 compared to an average monthly increase of $ 6.24 million USD in 2020 totaling $848 million USD, representing 86.7% of overdue liabilities in the entire healthcare sector. The main reason for the constant growth in the indebtedness of medical facilities is caused by continuing generation of operating losses in hospitals. Facilities owe to social fund, tax office, healthcare insurance companies, drug& medical material suppliers, energy providers and other medical institutions such as Slovak National Transfusion Service.
To avoid future debts, systematic changes like hospital stratification, implementation of the Diagnoses Related Groups classification system (DRG has been active since 2017 and is forecasted to be fully functional by the end of 2022), remuneration according to performance, and sanctions for mismanagement, are inevitable. Significant increases in efficiency are needed in medical processes, purchasing, and operations, otherwise hospitals need to receive more money from the insurance companies.
The government has decided to complete the structure of Bratislava hospital Razsochy. Construction of the new university hospital that should start operating in 2024, serving people from all over Slovakia with its 600 beds for an estimated cost of $310.34 million USD (€263 million) excluding VAT has not yet begun.
Best Prospects
Opportunities within Slovakia’s Recovery Plan worth USD 1.81 billion (EUR 1.53 billion):
Project preparation and project investment management
New network of hospitals - construction, reconstruction and equipment
Digitization in healthcare
Construction and renovation of ambulance stations
Renewal of the ambulance fleet
Support for the opening of new primary care clinics in deprived areas
2. Humane, modern and affordable mental healthcare
Creation of detention facilities
Construction of psycho-social centers
Supplementing the network of psychiatric hospitals
Construction of specialized centers for autism spectrum disorders
Carrying out the first epidemiological study in the field of mental disorders
Establishment of a fund of psycho-diagnostic methods
Humanization of departments in institutional care
Renewal of material and technical equipment for the implementation of standard procedures
Education of professionals in the department and outside the health sector
National Mental Health Support Line
3. Affordable and quality long-term social and health care
Expanding community social care capacities
Expansion and renewal of aftercare and nursing care capacities
Expansion and renewal of palliative care capacities
In 2018, Penta launched the largest private investment in Slovak healthcare. The New Generation Hospital scheduled to fully operate by 2023 is the most modern hospital in Central Europe. 14 top-class operating theaters, next generation urgent reception, eight intimate delivery rooms, robotic drug room, multidisciplinary healthcare, innovative processes and advanced radio-diagnostic equipment, and a single bed patient standard and healing environment will treat the most demanding patients from all over Slovakia. With state-of-the-art equipment, hotel services and patient-centered processes, the new hospital is designed to handle both the planned and acute cases at the highest European level, fully covered by public health insurance. The ambition of the USD 283.2 million (EUR 240 million) project is to attract the best doctors and nurses from Slovakia and abroad.
The following specific items were the leading exports from the U.S. to Slovakia ranked in USD from 2020 to 2021:
HS code
ITEM
2020
2021
9013
Lasers, Other Than Laser Diodes; Optical Appliances and Instruments, Nesoi
7,951,834
11,567,198
9018
Instruments And Appliances Used in Medical, Surgical, Dental or Veterinary Sciences (Including Electro-Medical and Sight-Testing); Parts Etc. Thereof
5,772,581
5,110,399
9027
Instruments and Apparatus for Physical or Chemical Analysis, Including Checking Viscosity, Expansion, Heat, Sound, Light Etc.; Microtomes; Parts Etc.
4,082,804
2,713,810
9022
Apparatus Based on X-Rays or Alpha, Beta, Gamma or Other Ionizing Radiations; Parts and Accessories
4,263,753
1,884,810
9031
Measuring or Checking Instruments, Appliances and Machines, Nesoi; Profile Projectors; Parts and Accessories Thereof
1,143,984
1,851,378
9026
Instruments and Apparatus for Measuring or Checking The Flow, Level, Pressure or Other Variables Of Liquids or Gases, Nesoi; Parts and Accessories
1,407,309
1,664,573
9028
Gas, Liquid or Electricity Supply or Production Meters, Including Calibrating Meters Therefor; Parts and Accessories Thereof
379,713
1,299,176
9001
Optical Fibers and Optical Fiber Bundles; Optical Fiber Cables Nesoi; Sheets and Plates of Polarizing Material; Optical Elements, Unmounted
556,797
1,053,538
9030
Oscilloscopes, Spectrum Analyzers Etc. for Measuring Etc. Electrical Quantities, Nesoi; Devices for Measuring Etc. Ionizing Radiations; Parts Etc.
2,546,985
821,831
9019
Mechano-Therapy, Massage, Psychological Aptitude-Testing Appliances and Apparatus; Ozone Etc. Therapy And Respiration Apparatus; Parts and Accessories
470,975
680,463
9029
Revolution and Production Counters, Taximeters Etc.; Speedometers and Tachometers Nesoi; Stroboscopes; Parts and Accessories Thereof
927,184
618,154
9021
Orthopedic Appliances; Splints Etc.; Artificial Parts of The Body; Hearing Aids and Other Appliances to Compensate for a Defect Etc.; Parts Etc.
1,107,784
553,276
9024
Machines and Appliances for Testing The Mechanical Properties of Materials (Hardness, Strength Etc. of Metal, Wood, Paper Etc.); Parts and Accessories
228,408
401,682
9015
Surveying, Hydrographic, Oceanographic, Hydrological, Meteorological or Geophysical Instruments Etc. Nesoi; Rangefinders; Parts and Accessories
407,015
123,713
9017
Drawing, Marking-Out or Mathematical Calculating Instruments; Hand Instruments for Measuring Length, Nesoi; Parts and Accessories Thereof
71,521
117,656
9005
Binoculars, Monoculars, Other Optical Telescopes or Astronomical Instruments, Except For Radio Astronomy; Parts and Accessories, Including Mountings
131,652
114,164
9032
Automatic Regulating or Controlling Instruments and Apparatus; Parts and Accessories Thereof
190,404
92,777
9002
Optical Elements (Including Lenses, Prisms and Mirrors), Mounted, Excluding Elements of Glass Not Optically Worked; Parts and Accessories Thereof
117,480
82,681
2019
2020
2021
2022 (Estimated)
Total Market Size
8,921,714
8,090,588
8,605,419
8,500,000
Total Local Production
8,256,000
7,525,589
7,955,998
7,800,000
Total Exports
917,976
857,888
969,237
900,000
Total Imports
1,583,690
1,422,887
1,618,658
1,600,000
Imports from the U.S.
43,559
39,594
31,025
35,000
USD thousands (total market size = (total local production + imports) - exports)
Data Sources:
Total Local Production: Statistical Office of the Slovak Republic
Total Exports: Global Trade Atlas
Total Imports: Global Trade Atlas
Imports from U.S.: Global Trade Atlas
Exchange Rate: European Central Bank
Main Competitors
Slovakia’s medical device manufacturing sector has a long history, particularly in the area of orthopedic and dental equipment. At present, Slovak companies largely produce single-use medical equipment, most of which (except orthotics) is exported to markets such as the Czech Republic. The biggest domestic players in the market are Unomedical, Chirana T.Injecta, Protetika, Biometrix, Chirana Medical, Neoprot, Diplomat Dental Solutions, and Ortoproplus.
Around 88% of the medical device market is supplied by imports, out of which Germany and the U.S. account for almost 50%.
The biggest suppliers to Slovak hospitals are MED-ART, Unipharma, TIMED, Phoenix, Narodna transfuzna sluzba, B.Braun Medical, Intravena, Johnson & Johnson, CaSS and Medical GroupSK.
The biggest local pharma producers are Saneca Pharmaceuticals, HBM Pharma, Hameln rds, Biotika, Imuna Pharm, Unimed Pharma, Innopharma, Pharmagal-Bio and Generica.
Local pharma companies include Johnson&Johnson, Novartis, Sanofi-aventis Slovakia, Bayer, Roche Slovensko, AbbVie, MSD, Teva Pharmaceutical Slovakia, Amgen, Merck, BGP Products, Zentiva, Lundbeck Slovensko, KRKA Slovakia, Eli Lilly, GSK.
A full list of wholesale drug distribution license holders can be found at https://www.sukl.sk/hlavna-stranka/slovenska-verzia/drogove-prekurzory/zoznam-velkodistributorov?page_id=4987
Ranking of pharmacies by 2020 profit is as follows: Dr. Max ($437 million USD), Benu ($106 million USD), Farmakol ($71 million USD) and Unipharma ($59 million USD).
Air rescue – HEMS (Helicopter medical rescue service) is provided out of seven operational centers by ATE, a private healthcare entity, based on a license granted by the Ministry of Health of the Slovak Republic. ATE has signed contracts with all local health insurance providers. Beyond HEMS, ATE provides medical air transport, business flights, special aerial works (construction works, logging, firefighting), helicopter service (AGUSTA Westland, Eurocopter, MIL helicopters and Bell maintenance, repairs), spare parts trading (spare parts supply, consultation service, spare parts inspections) and air crew training.
Svet zdravia, which belongs to the Penta financial group, operates 17 hospitals with 6,970 employees. Penta is the dominant private entity of the Slovak healthcare market with 13 ProCare policlinics, the Dr. Max pharmacy network, insurance company Dovera, and Klient Pro (a company specializing on “controlled healthcare” projects’ development and administration).
Insurance Company
Market Share
Policyholders
2021 Profit (+) / Loss (-)
VsZP (public) 56.00%
2,896,138
- EUR 87.286 million
Dovera (private) 31.93%
1,651,152
+ EUR 10.548 million
Dovera (private) 12.07%
624,384
+ EUR 3.534 million
Based on preliminary reports in accordance with Slovak legislation, health insurance companies in 2021 reported a total loss of $86 million USD (€73 million), which represented an improvement of USD85 million USD compared to the previous year. According to the European standard, none of the three health insurance companies has sufficient capital, specifically the VsZP (General Health Insurance Company) needing more than $708 million USD, followed by Dovera missing almost $354 million USD and Union in need of more than $94.4 million USD.
AGEL, as the most successful private healthcare provider in Central Europe, has been active in the Slovak market since 2006 through its subsidiary AGEL SK. In Slovakia, it currently operates 14 hospitals, a health service and other healthcare providers, including AGEL Lab.
The two biggest players in the laboratory segment are Medirex Group and Unilabs Slovensko.
Current Demand
Slovakia has excellent market opportunities in the fields of sophisticated health technologies and equipment, dental care equipment, and many other devices that increase efficiency and reduce occupancy rates in hospitals.
The new Minister of Health wants to imitate the nominal health insurance system from the Netherlands and Switzerland. Insurers would offer special packages to patients including a higher standard of care in hospitals, arranged treatment at a doctor’s office, or special treatment via phone. Insurers choosing among various packages of health insurance would bring extra financial sources into the system; however, it is not clear yet how much it would cost, whether the extra insurance would be mandatory or voluntary, or how this system would work for State policy holders.
Science parks and research centers, such as University Science Park for Biomedicine, Biomed, Medi Park Kosice, Bratislava Comenius University Science Park, University Science Park Technicon Kosice, and University Science Park Cambo Trnava, play an important role in the national innovation system by stimulating cooperation between the academic and business environments and enabling a swift knowledge transfer. The Slovak government supports R&D investment opportunities with high added value in medical technologies, healthcare industry, biomedicine, and innovative pharmaceuticals.
Slovakia’s $122 million USD (€103.3 million) e-Health program has taken ten years to implement. It introduces many significant changes to the Slovak health system (e.g. an e-prescription process should soon render paper prescriptions obsolete and patients’ records should be stored in a central database, improving coordination between primary care doctors, specialists, and laboratories.). Future opportunities may lie within e-Health domains such as:
Publicly accessible relevant information sharing (e-Health information, e-Warning, e-Learning, eHealth forum, e-Library /SILK, e-IZ WHO)
Allocation (e-Booking, e-Referral, e-Waiting list, e-Vaccination, e-Reminder, e-Laboratory, e-Calendar management, e-National Transfusion Service)
Medication/prescription (e-Medication, e-Pharmacy)
EHR (Electronic health record providing, Emergency data set providing, patient’s personal account)
e-Health managerial support (health providers rating, e-Monitor, e-Statistics, e-Report, aggregated demographic information, Epidemiologic situation)
Picture archiving and communication system (PACS)
Infrastructure management (National Health Portal, e-Registry, Interface, SK SNOMED, Health professional card, Health insurance card, national operator’s services)
Management and verification of financial flows (e-Clearing, e-Filling, e-Verification)
Telemedicine (tele-monitoring, tele-care, tele-radiology, tele-dermatology, tele-consulting)
Other (EBM support, e-Genomics, e-consulting, Call center health support, e-Counselling, e-First Aid)
Since January 1, 2018 e-Health reports over 253 million e-prescriptions and over 96 million electronically recorded examinations. The total savings on e-prescriptions solely is almost $40.71 million USD (€34.5 million).
Registration Process
Please see the Slovak State Institute for Drug Control for Slovakia’s potential registration specifics beyond European Union registration regulations and laws.
Reimbursement
The Slovak health system is based on statutory health insurance, a basic benefit package and universal population coverage. The main sources of public revenues for health spending are contributions from employers, employees, the self-employed, and the state contributions for economically inactive persons. Private expenditures, mainly consisting of out-of-pocket payments, are a subject of ongoing debate. Health insurance companies (VsZP, Dovera and Union) are legally obliged to ensure healthcare for their insured population and compete on quality and prices. They are free to contract with providers and negotiate quality, prices and volumes individually. To guarantee accessibility of providers, insurance companies are mandated to maintain contracts with a minimum set of providers designated by type of service and specialization in each region (the so-called minimum network requirement set by the government).
Medical device or pharmaceuticals importers may sometimes have problems in obtaining approval to be placed on insurance reimbursement lists – something that is also a challenge in other Central and Eastern European countries. If a product is not included on the reimbursement scheme paid by insurance companies, the market for the product is limited. The catalog of reimbursed operations, medical aids, and pharmaceuticals is reevaluated every three months. Drug categorization takes place on the first day of the month.
The list of categorized medicines can be viewed here . Drug price referencing is executed twice yearly. More on categorized medical aids can be viewed here .
Barriers
Hospitals fail to observe the maturity of supplier-consumer invoices set by law to 60 days and in the public sector to 30 days. Strong connections between hospitals and government and a low number of private investors are key factors contributing to Slovak hospitals’ constant increase in debt.
Geographical availability and complexity of health care depends on sufficient medical staff and specialized medical staff in the sector. Slovakia faces shortage both in doctors and nurses. An estimated 170 new GP jobs should be created between 2022 and 2026. The shortage of doctors is partially covered by doctors from outside the EU - mostly from Ukraine, Russia, Uzbekistan, Tajikistan, or Palestine. In the future, these doctors will work under the “Institute of Temporary Professional Internship,” a special regime, lasting up to one year, with a similar status to doctors without postgraduate certification or medics. The average age of GPs for adults is currently 59 years and for children and adolescents 61 years.
The system of education of healthcare workers is poorly managed and therefore does not respond to strategies related to improving the quality of services provided to patients. In connection with the arrival of new technologies such as telemedicine, the use of applications and smart devices, micro medicine, robotic workplaces, the use of artificial intelligence in disease diagnosis, it is very important to pay attention to the readiness of human resources for innovation in the sector.
Based on the latest analysis of 38 countries by the European Federation of Pharmaceutical Industries and Associations, Slovakia ranked among the worst countries in Europe as it lags behind in innovative medicines, especially in oncology. While the neighboring Czech Republic introduced to market seven oncological drugs (Slovenia eight and Romania nine), Slovakia approved only four last year.
Procurement & Tenders
Public procurement and tenders are executed according to the Public Procurement Law, effective as of June 1, 2017. In order to save money, the Ministry of Health procures aids and supplies centrally. It is obligatory for the state, municipalities, and higher territorial units (regional governments), as well as organizations established or linked to them to purchase via Central Marketplace. This is if the value of the goods, services, or construction works exceeds € 5,000,000 excluding VAT, and reaches a maximum of €134,000 excluding VAT for the State, and €207,000 excluding VAT for other contracting authorities. For construction works, the ceiling is €5,186,000, excluding VAT. All Slovak public tenders can be found at the Slovak Public Procurement Office and also at Portal for EU Tenders.
Frequently Asked Questions
1. Is the CE mark enough to export a medical device to Slovakia? SUKL ). It is a registration not an approval. The registration can be done either by the manufacturer or the distributor in the name of the manufacturer. It requires submission of cover letter, manufacturer’s empowerment, registration form/notification, form’s annex, codes of internationally recognized nomenclature, EU Declaration of Conformity, ES / EU Certificates, use instructions in Slovak language, specifics on the medical device’s labeling (outer packaging), and technical documentation. For more information please go here or contact the Slovak Institute for Drug Control (SUKL ).
2. What is the custom import health clearance? here requiring electronic signature, and official websites’ English versions are very limited), it is highly recommended to hire a local agent well acquainted with the TARIC SK , customs formalities and customs processing.
3. What are the major sales channels in Slovakia?
U.S. Commercial Service Contact Information
Name: Lucia Maskovalucia.maskova@trade.gov
