Healthcare Resource Guide: Slovakia

Slovak Statistics

Summary

Market Entry

Current Market Trends

Main Competitors

Current Demand
Registration Process

Reimbursement

Barriers
Procurement & Tenders

Trade Events

Best Prospects
CS Contacts

Capital: Bratislava

Population: 5.4 million

GDP: USD 90 billion

Currency: Euro (EUR)

Language: Slovak

Summary

Slovakia’s market size is similar to Hungary, or in per capita terms to Spain. Being centrally located in Europe, there are 300 million clients in a radius of 1,000km (625miles), and 600 million in 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. Despite that, Slovak State hospitals were paid out in the past, they constantly generated debts. Professionals repeatedly call for a system change in form of hospitals becoming stock companies or holding management, introduction of independent authorities and external audits. According to the Health Consumer Powerhouse study based on WHO and OECD data, Slovakia has been criticized for missing e-prescriptions, planned surgeries availability within 90 days, long waiting times for treatment, insufficient decline in deaths caused by cardiovascular diseases and strokes, many lost years (number of life years people could gain with better healthcare) and frequent staphylococcus occurrences in hospitals. The 2018 budget for the Slovak Ministry of Health is EUR 1.37 billion (USD 1.55 billion.) The sector’s growing debt of EUR 1.464 billion (USD 1.65 billion) by the end of 2017 remains the biggest problem in healthcare.

Market Entry

Slovakia is one of the more developed health device and pharmaceutical markets in the Central and Eastern European region. Euro zone 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, who 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 2018 Global Health Care Outlook by Deloitte using 2016 OECD data, Slovakia’s healthcare expenditures as a share of GDP is 7%, which is identical with Hungary & Poland and similar to Czech Republic (7.5%) compared to USA’s 16.9%.

Though the healthcare is publicly available and considered “for free” Slovak households spent about EUR 1.7 billion (USD 1.92 billion) for healthcare goods (mostly over the counter drugs, 39% of which were drugs treating the cardiovascular system) and services. Despite having some of the cheapest drug prices in the EU, Slovak spending for drugs is the third highest in the EU (26.9%, source OECD 2015).

Health insurance companies paid EUR 867 million (USD 980 million). The most prescribed medicines were NOVALGIN (almost 1.5 million packs), AGEN (782 thousand packs) and CONCOR (771 thousand packs). The most over-the-counter drugs sold were Paralen 500 (1.9million packs), Ibalgin 400 (870 thousand packs) and Muconasal (860 thousand packs).

In 2017, Slovaks returned to pharmacies 133.3 tons of unused/expired drugs,15 tons more than in 2016 and 2017. The biggest amount of drugs (30.60 tons) was returned in the Bratislava region. The collection and subsequent disposal of unused/expired pharmaceutical products is provided twice a year (spring and autumn) by Modrá Planéta Ltd. for pharmacies free of charge. The service is paid by Slovak State Institute for Drug Control.

The European Commission stopped legal action against Slovakia for its medicine re-export measures. The EC has acknowledged that drugs were not a normal commodity, and the risk for patients due to a shortage of medicines should be regulated despite the free movement of goods. Slovakia faced massive re-export in October 2016 while Slovak pharmacies were short by 2,644 different types of drugs. By May 2017 this number dropped to only 2 types of drugs a day due to Act No. 306/2016 Coll. amending Act No. 362/2011 Coll. on Medicinal Products and Medical Devices which came into effect on January 1,2017 when medicines covered by public health insurance could only be exported by their manufacturers and the registration holders, not the distributers.

The EUR 87 million (USD 98.3 million) e-Health program took 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; 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-NTS (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)

Launch of Diagnoses Related Groups (DRG) classification system remains Slovakia’s priority. Active since 2017, the DRG system is forecasted to be fully functional in 2022.

Under the auspices of the Slovak Ministry of Health, there are 74 healthcare providers divided into three groups. While domestic and international experts believe 30 hospitals are optimal, the Slovak government plans on keeping 40 to 45 full-valued hospitals (must have ER, surgery, 300 – 400 beds, access to EU funds) while the rest should gradually transform into specialized hospitals, one day surgery facilities, after-treatment facilities, sanatoriums, clinics or first aid service stations. Profiling the new basic hospital network is based on defining various criteria (70 thousand inhabitants’ perimeter, accessibility within 60 minutes, amount of hospitalizations, current bed conditions, etc.).

On July 1, 2018, The Slovak Ministry of Health launched a new system of the long criticized existing outpatient alert system. The new system will eliminate disproportionate overloading of doctors who have been on night duty despite empty waiting rooms to work in ambulances the following day.

Heath care debt genesis in million EUR (2017 rate of exchange is 1EUR/1.13USD)

 

2013

2014

2015

2016

2017

Ministry of Health hospitals

403.54

473.69

589.94

702.13

833.69

Ministry of Interior hospitals and healthcare providers

28.34

34

31.84

39.91

39.72

Self-governing regions hospitals

162.81

137.3

145.14

125.78

131.24

Institutions transformed into stock companies

65.46

63.58

61.5

57.47

60

Healthcare Insurance companies

593.61

533.76

549.4

457.1

399

Total

1,253.76

1,242.33

1,377.82

1,382.39

1,463.65

Thirteen faculty hospitals generated 82% of the debt. 52.7% of the hospitals’ debt are in form of unpaid invoices for drugs and special medical material, 30.1% is unpaid contributions to social insurance. Via multiple rounds, starting 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 (USD 661 million).

Thirty years after the construction of the Bratislava hospital Razsochy was launched, the State decided to complete the structure as the facility has never been built. The new university hospital should start operating in 2022, serving people from all over Slovakia with 600 sickbeds. The estimated cost is EUR 263 million excluding VAT (USD 297 million). In February 2018 The Slovak Ministry of Health announced a EUR 17 million (USD 19.2 million) tender for demolition contractor of Razsochy skeleton.

The Slovak Ministry of Health introduced the National Oncology Program which will help reduce the increasing number of oncology patients. The ministry is also launching the “Year of Prevention” that will inform people about their options and possibilities. (Cancer is the second deadliest disease after cardiovascular diseases. According to the analysis of malignant tumors, Slovaks die mostly of stomach cancer and larynx or breast carcinoma.)

Main Competitors

Slovakia’s medical device manufacturing sector has a long history, particularly in the area of orthopedic and dental equipment. At presents Slovak companies 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 USD 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 European Union markets. Around 88% of the medical device market is supplied by imports, out of which Germany and the U.S. account for almost 50% of it.

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 with 2017 turnover amounting to EUR 518,196 (USD 585,562) and Unipharma (30% market share with 2017 turnover amounting to EUR 473,915 (USD 535,524)) 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.

Plus Lekaren (Unipharma) with over 500, Partner (Phoenix) with 470, Vasa Lekaren (Med Art) with 270 and Druzstvo lekarni with approx. 100 pharmacies are the biggest independent pharmacy associations and virtual alliances. Dr. Max with 276 pharmacies and Benu with 70 pharmacies are the two biggest pharmacy networks, followed by Apotheke with 64, Farmakol with 53 and Schneider with 47 pharmacies.

Falck Zachranna with 150,000 annual departures, 1,400 employees, 107 rescue stations (32 emergency medical assistance stations and 75 emergency healthcare facilities) is the biggest player in the Slovak rescue market (39% market share). Besides ambulances, Falck Healthcare provides preventive and therapeutic healthcare in three of its policlinics and in three specialized rehabilitation centers (Bratislava, Poprad, 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 the 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 already operates fourteen hospitals. Penta is with ProCare policlinics hospitals, Dr. Max pharmacy network, insurance company Dovera (holds almost 1/3 of the Slovak market) and Klient Pro (a company specializing on “controlled healthcare” projects’ development and administration) the dominant private entity of the Slovak healthcare market.

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 4,400 employees in Slovakia it currently operates eleven hospitals, a specialized hospital in Bratislava, a health service and other healthcare providers. Agel SK treats overs 1.8 million outpatients and hospitalizes more than 71,000 patients on yearly basis. In 2017 the company’s investments in healthcare facilities in Slovakia exceeded EUR 1.4 million (USD 1.6 million).

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 Health Minister wants to copy the nominal health insurance system from the Netherlands and Switzerland. Insurers would offer special packages to the patients including higher standard in hospitals, arranged treatment at the doctor's 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, and how this system would work for State policy holders.

Despite the debts in hospitals, one of the main priorities is their modernization. In 2017, Ministry of Health has already allocated EUR 153 million (USD 173 million) to help forty-four hospitals out of which twelve are State-run, eight are run by regional governments, one is run by Kežmarok city, five are nonprofit organizations and the rest are private entities. The call for the renovation and modernization of hospitals is divided into two rounds. The first round has been issued in May 2017 in the amount of EUR 70 million (USD 79 million). The second round is expected to be issued in 2018. By 2020, there are EUR 278 million (USD 314 million) available for drawing. The full listing of eligible requestors can be found here. Massive investments into Slovak hospitals were reconfirmed in 2018 by the current Prime Minister though the amount has not been publicly disclosed.

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 the cooperation between the academic and business environments, and enabling a swift knowledge transfer. Slovak government supports any R&D investment opportunities with high added value into medical technologies, healthcare industry, biomedicine and innovative pharmaceuticals.

Registration Process

Please see 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 (Vseobecna Zdravotna Poistovna (publicly owned, 62% market share as of December 31, 2017), Dovera (privately owned, 27.88% market share as of December 31, 2017) and Union (privately owned, 10.12% market share as of December 31, 2017) 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 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. In reality, hospitals fail to observe the law and the average maturity is 330 days. Based on publicly available data from 2017, some invoices were already 670 days overdue. The factors contributing to Slovak hospitals constantly increasing debts are mainly strong connections between hospitals and government and a low number of private investors.

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. Catalogue of reimbursed operations, medical aids and pharmaceuticals is reevaluated every three months. Drug categorization takes place on monthly basis, on the first day of the month. 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

Slovak healthcare has been struggling with doctors’ shortage in the rural areas and overall insufficient numbers of nurses. Based on the latest OECD Health Policy in Slovak Republic published in March 2017, Slovakia has a declining number of nurses as many retire or leave to work abroad (Slovak Chamber of Nurses and Midwives resource claims that more than 400 nurses left to work abroad within the last five years) while the younger generation is not interested in this profession due to low monthly pay (a nurse with MSN and a five year experience at a State hospital is paid EUR 912 (USD 1,031). In some areas one nurse is responsible for thirty patients. The Ministry of Health’s idea to switch from grade/worked years pay to performance pay hasn’t been yet set by law. There are 5.8 Slovak nurses per 1,000 inhabitants while the OECD average is 9.1. According to the Slovak Chamber of Nurses and Midwives, Slovakia is short by 12,000 nurses. However, the Ministry of Health claims the number calculated with OECD methodology is only 1,925 nurses.

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, higher territorial units (regional governments) as well as organizations established or linked to them (entities not in the position of contracting authority which have been provided at least 50% of the projected value of the contracting authority) to purchase via Central Marketplace if the value of the goods, services or construction works exceeds EUR 5,000 (USD 5,650) excluding VAT and reaches maximum of EUR 134,000 (USD 151,420) excluding VAT for the State and EUR 207,000 (USD 234,000) excluding VAT for other contracting authorities. For construction works, the ceiling is EUR 5,186,000 (USD 5,860,000) excluding VAT. All Slovak public tenders can be found at the Slovak Public Procurement Office and also at Portal for EU Tenders.

Trade Events

Name of event: SLOVAK DENTAL DAYS

Location: Kongresové centrum X-bionic sphere, a. s., Šamorín

Date: October 11-13, 2018

Website: http://www.skzl.sk

Description: Exhibition of dental instruments, tools and materials supported by workshop on “The national recommendations for prevention tooth decay in children in practice dental team”

FAQs

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 medical device’s labeling (outer packaging), 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 can be administratively very complex ( e.g. customs declaration can only be submitted electronically here requiring electronic signature, 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.

Best Prospects

The following major government medical and health projects are planned for 2018 and 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 (USD 297 million) plus the cost of the reconstruction of Ružinov (EUR 80 million /USD 90.4 million).

The following specific items were the leading exports from the U.S. to Slovakia covered by this Leading Sector, ranked in USD from 2016 to 2017:

HS code

ITEM

2016

2017

9018

Medical, Surgical, Dental Or Vet Inst, No Elec, Pt

10,978,373

7,348,921

9022

X-Ray Etc Apparatus; Tubes, Panels, Screen Etc, Pt

763,500

5,628,634

9031

Machines, Nesoi In Chapter 90; Profile Project, Pt

3,044,380

3,702,383

9027

Inst Etc For Physical Etc Anal Etc; Microtome; Pts

1,267,937

2,645,667

9002

Optical Elements, Mounted; Parts & Accessories

631,515

1,023,319

9029

Revolution & Production Count, Taximeters Etc, Pts

775,183

855,439

9030

Oscilloscopes, Spectrum Analyzers Etc, Parts Etc

490,153

810,937

9001

Opt Fibers & Bund Etc; Pol Sheets; Unmoun Opt Elem

662,002

789,679

9013

Liquid Crystal Devices Nesoi; Lasers; Opt Appl; Pt

1,373,770

733,032

9021

Orthopedic Appl; Artif Body Pts; Hear Aid; Pts Etc

782,771

692,436

9026

Inst Etc Measure Or Check Flow, Level Etc, Pts Etc

684,079

604,418

9014

Direction Finding Compasses & Navig Inst Etc, Pts

239,500

537,440

9019

Mech-Ther, Massage, Psych Test, Ozone App Etc, Pts

209,401

471,711

9032

Automatic Regulating Or Control Instruments; Parts

142,475

319,302

9015

Survey, Hydrogr, Meteoro Etc Inst; Rangef Etc, Pts

187,243

270,599

9024

Machines Etc For Testing Mech Prop Of Material, Pt

273,491

182,299

9005

Optical Telescopes & Mount; Astro Inst & Mount, Pt

16,099

174,756

9033

Pts, Nesoi For Machines,Appln,Inst/Appts Of Chap90

196,092

127,283

U.S. Commercial Service Contact Information

Name: Lucia Maskova

Position: Commercial Specialist

Email: lucia.maskova@trade.gov

Phone: 011 421 2 5922 3325


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