Last Updated: October 2019
Current Market Trends
Procurement & Tenders
Population: 5.4 million
GDP: EUR 88.6 billion (2018)
Currency: Euro (EUR)
Slovakia’s market size is like that of Hungary, or in per capita terms, to that of Spain. Being centrally located in Europe, there are 300 million people in a radius of 1,000km (625miles), and 600 million within 2,000km (1,250miles). 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 e-prescriptions, problems with availability of planned surgeries within 90 days, 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. The 2019 budget expenditure for the Slovak Ministry of Health is EUR 1.2 billion versus a 2018 budget of EUR 1.4 billion. The sector’s growing debt of EUR 1.5 billion by the end of 2018, remains the biggest problem in Slovak healthcare.
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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.
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 $2,290 per capita which is comparable to Hungary ($2,047) and Poland ($2,056), and like the Czech Republic ($3,033), as opposed to the United States (U.S.) ($10,586).
Though healthcare is publicly available and considered “free,” Slovak households are spending more money on healthcare goods (mostly over-the-counter drugs) and services than before. 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. Total 2018 drug consumption in Slovakia grew year-over-year by 4.2% and represents 161 million packs worth EUR 1.79 billion (out of which EUR 426.5 million was covered by patients and EUR 1.37 billion was paid by health insurance companies). As of January 2019, reimbursement of drugs is based not on number of patients but on disease prevalence. The most expensive prescription drugs were Vessel Due F (veins treatment), Enelbin 100 Retard (hyperemia disorder) and Lagosa tb (liver damage by toxins). The top three most prescribed drugs were Novalgin 500, Concor and Agen. The top three over-the-counter drugs were Paralen 500, Muconasal Plus an Ibalgin 400. The record consumption forced the Slovak Ministry of Healthcare to launch a reimbursement policy revision to compare the reimbursement price per unit of comparable products and avoid payment for the same product in different packaging.
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.
Based on the International Monetary Fund Country Report 2019, the authorities have completed thematic expenditure reviews of two-thirds of public spending under the Value for Money program, identifying total savings of 0.9% of Gross Domestic Product (GDP) in 2019. So far, implementation has been limited to the health sector, where there have been cost savings from central procurement of prescription drugs and medical equipment, however, rising operational costs of public hospitals are yet to be addressed.
Slovak health care debt of EUR 1.5 billion is generated by healthcare insurance companies (26%) and by hospitals and healthcare facilities (74%). Through three rounds (the first in summer 2018), the Slovak Minister of Health via its company Debitum, will eliminate debts of both state and non-state hospitals in the amount of EUR 585 million. EUR 191 million is earmarked for thirteen faculty and university hospitals, which generated EUR 339 million in debt due to increasing personnel costs (3/4 of hospital expenditures), unpaid invoices for drugs and specialized medical material, and unpaid contributions to social insurance. By July 2019, 29 hospitals had received money to reduce their debts.
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 in 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.
Thirty years after the construction of the start of Bratislava hospital, Razsochy, the government has decided to complete the structure. The new university hospital should start operating in 2022, serving people from all over Slovakia with its 600 beds. The estimated cost is EUR 263 million excluding VAT.
In 2018, the Slovak Ministry of Health introduced the National Oncology Program to help reduce the increasing number of oncology patients. Cancer is the second deadliest disease after cardiovascular diseases. According to analysis of malignant tumors, Slovaks die mostly of stomach cancer and larynx or breast carcinoma The ministry has launched the “Year of Prevention,” informing people about their options and possibilities. Expenditures by the three insurance companies on prevention represented EUR 96 million (VsZP EUR 61 million, Dovera EUR 26 million, Union ZP EUR 9 million) in 2018.
The Economist defines excessive profits as a return on invested capital (ROIC) of more than 10%. In Slovakia, the most profitable companies exceeded this rate by multiples:
Average ROIC 2013-2017
Klinicka Biochemia Ltd.
Supplier of drugs and medical aid/technology
Prosthesis and orthopaedic aids
Falkc Zachranna Stock comp.
Private rescue service provider
Kadiocentrum Nitra Ltd.
Private cardio center
Nemocnia Kosice – Saca Stock comp.
Zentiva Stock comp.
Amgen Slovakia Ltd.
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. Domestic medical device production is estimated to be in excess of $300 million. The biggest players in the market are Unomedical, Chirana T.Injecta, Protetika, Biometrix, Chirana Medical, Neoprot, Diplomat Dental Solutions, and Ortoproplus. The Slovak medical device market is dominated by imports, mainly from the U.S. and EU markets. 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 local pharma producers are Saneca Pharmaceuticals, Biotika, HBM Pharma, Imuna Pharm, and Innopharma.
The biggest licensed pharmaceutical distributors are Phoenix (38% market share) and Unipharma (30% market share), followed by Med-Art, Johnson & Johnson, and Transmedic Slovakia. U.S. pharmaceutical companies Amgen Slovakia s.r.o., Abbvie s.r.o., Baxter Slovakia s.r.o., Biogen Slovakia s.r.o., Eli Lilly Slovakia s.r.o., Janssen-Cilag s.r.o., Johnson & Johnson, s.r.o. Slovakia, Merck Sharp & Dohme, s.r.o., and Pfizer Luxembourg SARL have a 30% market share. A full list of wholesale drug distribution license holders can be found at https://www.health.gov.sk/Clanok?zoznam-drzitelov-povoleni-na-velkodstribuciu-liekov.
Plus Lekaren (Unipharma), with over 500 pharmacies, Partner (Phoenix), with over 470, Vasa Lekaren (Med Art), with 278, and Druzstvo lekarni, with approximately 100, are the biggest independent pharmacy associations and virtual alliances. Dr. Max, with 304 pharmacies, and Benu, with 76 pharmacies, are the two biggest pharmacy networks; followed by Apotheke, Farmakol, and Schneider pharmacies.
Falck Zachranna a.s., with 150,000 annual departures, 1,400 employees, 107 rescue stations (27 emergency medical assistance stations and 80 emergency healthcare facilities,) and 2018 profit of EUR 1.5 million, is the biggest player in the Slovak rescue market (39% market share). In addition to ambulances, Falck Healthcare provides preventive and therapeutic healthcare in three of its poli-clinics and in three specialized rehabilitation centers (Bratislava, Poprad, and Kosice). Falck is also locally known through Falck Fire Services (industrial fire protection and fire services offered in Slovakia and Romania), Falck Academy (first aid courses), Falck Pharma (pharmacy), and Falck n.o. (non-profit organization).
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, fire-fighting), 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 12 ProCare policlinics, the Dr. Max pharmacy network, insurance company Dovera, and Klient Pro (a company specializing on “controlled healthcare” projects’ development and administration).
Health insurance market in numbers
EUR 89.98 million
EUR 35.5 million
EUR 9.9 million
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. With 4,200 employees in Slovakia, it currently operates ten hospitals, a specialized hospital in Bratislava, a health service and other healthcare providers. AGEL SK treats overs 1.8 million outpatients and provides inpatient hospital care for more than 71,000 patients on yearly basis.
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.
Hospitals are also prioritizing modernization. Spending on revitalization of Slovak hospitals amounted EUR 240 million in last three years. EUR 150 million from EU funds was used to build emergency facilities in 44 hospitals. The full listing of eligible requestors can be found here. Since the Bratislava region cannot draw on EU funds, EUR 70 million will come from the state budget.
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 EUR 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:
Currently 66% of medical facilities use e-Health. 12,000 ambulances prescribed 69 million e-prescriptions (half the plan). Since patients are not very interested in their online medical history, they are not requesting their doctors to enter the system. However, by 2022 all patients should be holders of e-ID cards with a chip that will allow them to access the e-Health system.
Please see the Slovak State Institute for Drug Control for Slovakia’s potential registration specifics beyond European Union registration regulations and laws.
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).
In February 2013, the maturity of supplier-consumer invoices was set by law to 60 days and in the public sector to 30 days. Hospitals fail to observe the law and the average maturity is 330 days, in some cases even 670 days overdue. By the end of 2018, suppliers of medical aids recorded over EUR 130 million in outstanding claims. Strong connections between hospitals and government and a low number of private investors are key factors contributing to Slovak hospitals’ constant increase in debt.
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.
Slovak hospitals employ 6,441 doctors. Based on the 2018 OECD data, over 4,000 Slovak doctors work abroad, primarily in the Czech Republic (2,218, not including Slovak students who completed their MMed degree in the Czech Republic and joined the Czech medical workforce), Germany (1,062), and Norway (406). In order to avoid losing more personnel, the government has increased their salaries, continuous with a residential program, and raises the application quotas for medical faculties. So far, 100 general practitioner and pediatrician fresh graduates have been enrolled. These medics are working in hospitals from three to five years, based on a specialization, and receiving necessary experience. Young medics are also given an opportunity to obtain a specialization. While currently it is possible to study ten specializations, another eight will be added in October 2019. The shortage of 5,549 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.
Despite employing 16,728 nurses, hospitals have been reporting a shortage of 3,500 nurses for years. The government has addressed this problem with changes in the educational system and increased salaries to incentivize nurses not to leave for work abroad. The Slovak Parliament has decided that nurses can be educated not only at bachelor's level, but at almost every secondary medical school. The current eight medical secondary high schools providing such degree will soon increase to 27.
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 EUR 5,000, excluding VAT, and reaches a maximum of EUR 134,000, excluding VAT, for the state, and EUR 207,000, excluding VAT, for other contracting authorities. For construction works, the ceiling is EUR 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.
Name of event: Slovak Dental Days 2019
Location: Kongresové centrum X-bionic sphere, a. s., Čilistov
Date: October 10-12, 2019
1. Is the CE mark enough to export a medical device to Slovakia?
No. In order to export a medical device to Slovakia, the device needs to be registered with the Slovak Institute for Drug Control (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?
All medical devices entering the Slovak market will be checked at customs. Since the import process can be administratively very complex ( e.g. the customs declaration can only be submitted electronically 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?
Medical devices are sold via distributors of drugs and medical devices.
The following major government medical and health projects are planned for 2019:
Construction of a new hospital in Bratislava with 578 beds and top-notch medical technology should be finished by 2022. The new hospital will have to purchase medical laboratory equipment, diagnostic medical equipment, life support equipment, and treatment equipment. The total construction project volume is estimated at EUR 263 million plus the cost of the reconstruction of Ružinov (EUR 80 million).
The Slovak Ministry of Health is amending the radiation law in order to allow larger purchases of X-ray equipment. Based on statistical data, Slovakia compared to other Visegrad countries has the highest number of CT exams due to absence or unavailability of X-rays. Slovak state hospitals should have received 136 new X-ray machines already in Spring 2019.
In 2018, Penta launched the largest private investment in Slovak healthcare. The New Generation Hospital scheduled to fully operate by January 2022 will cost EUR 240 million. 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 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 covered by this Leading Sector, ranked in USD from 2017 to 2018:
X-Ray Etc Apparatus; Tubes, Panels, Screen Etc, Pt
Medical, Surgical, Dental or Vet Inst, No Elec, Pt
Machines, Nesoi In Chapter 90; Profile Project, Pt
Inst Etc For Physical Etc Anal Etc; Microtome; Pts
Automatic Regulating or Control Instruments; Parts
Optical Elements, Mounted; Parts & Accessories
Opt Fibers & Bund Etc; Pol Sheets; Unmoun Opt Elem
Orthopedic Appl; Artif Body Pts; Hear Aid; Pts Etc
Inst Etc Measure or Check Flow, Level Etc, Pts Etc
Revolution & Production Count, Taximeters Etc, Pts
Liquid Crystal Devices Nesoi; Lasers; Opt Appl; Pt
Oscilloscopes, Spectrum Analyzers Etc, Parts Etc
Survey, Hydrogr, Meteoro Etc Inst; Rangef Etc, Pts
Mech-Ther, Massage, Psych Test, Ozone App Etc, Pts
Inst, Appts&Models, For Demonstrational Use& Parts
Direction Finding Compasses & Navig Inst Etc, Pts
Machines Etc For Testing Mech Prop of Material, Pt
Gas, Liquid or Electric Supply Etc Meters, Parts
Total Market Size
Total Local Production
Imports from the U.S.
Exchange Rate: 1 USD
USD thousands (total market size = (total local production + imports) - exports)
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
U.S. Commercial Service Contact Information
Name: Lucia Maskova
Position: Commercial Specialist
Phone: 011 421 2 5922 3325
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