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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: 5.41 million

GDP*: USD 89.61 billion (2016)

Currency: Euro (EUR)

Language: Slovak

Summary

Slovakia’s market size is similar to Hungary, or in per capita terms, to Spain. 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 the fact that Slovak State hospitals were paid in the past, they constantly generate debts. Professionals repeatedly call for a system change in the form of hospitals becoming stock companies/or holding management, introducing 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 time for treatment, insufficient decline in deaths caused by cardiovascular diseases and strokes, many lost years (number of years people could gain with better healthcare), and frequent staphylococcus occurrence in hospitals. Consistent with the Bloomberg Global Health Index, impacting factors like life expectancy, causes of death and health risks ranging from high blood pressure and tobacco use to malnutrition and the availability of clean water, Slovakia placed 46th of top 50 countries surveyed. The 2017 budget for the Slovak Ministry of Health is EUR 1.37 billion (USD 1.45 billion). Growing debt - EUR 547million (USD 580 million) by the end of 2016 - in the sector remains the biggest problem in the 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 who 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 percent. Some products carry a 10 percent VAT.

Current Market Trends

  • Medical Devices

The Slovak medical device market is expected to grow by 3.9 percent between 2013-2018, as the economy grows and health spending remains high. In 2013, the Slovak medical device market was estimated at USD 545 million (USD 100 per capita), and should reach USD 659.9 million (USD 121 per capita) by 2018.

Based on European Commission’s analyses on Fiscal Sustainability of Health Care and Long-term Care Systems Slovakia’s health spending of 8.2 percent GDP is below the EU average (10.1 percent), however at the same time higher than in other V4 countries (Hungary 8.1 percent, Czech Republic 7.2 percent and Poland 6.7 percent). Though healthcare is publicly available and considered “for free,” Slovak households spent about EUR 1 billion (USD 1.06 billion) for healthcare goods (mostly over the counter drugs) and services in 2016.

  • Drugs

Drugs are one of the most expensive areas of Slovak healthcare. It is expected that spending on drugs, medical devices and special healthcare material will decrease in 2017 by EUR 105 million (USD 111 million) through measures implemented to address the areas of over-consumption and drug & medical aids referencing. According to the Slovak National Information Center, in 2016 Slovaks consumed almost 83.2 million packs of prescription drugs fully or partially covered by health insurance. Health insurance companies paid EUR 911.9 million (USD 967 million), which represents an increase of 4.2 percent compared to the previous year. Patient surcharges increased by USD 5.4 million to EUR 141.1 million (USD 149.6 million). The top three prescribed drug categories were drugs treating cardiovascular system (28.1 million packs), nervous system (14.6 million packs), and the digestive tract & metabolism (8.9 million packs). The most prescribed medicines were NOVALGIN (almost 1.5 million packs), AGEN (782 thousand packs) and CONCOR (771 thousand packs).

In 2016, Slovaks bought 37.5 million packs of over-the-counter drugs (respiratory diseases (8.6 million packs), gastrointestinal diseases & metabolism (8.1 million packs), and nervous system disorders (nearly 7 million packs, of which 6.6 million packs were analgesics)) worth EUR 170.2 mil. (USD 180.4 million). The top three over-the- counter drugs were PARALEN, IBALGIN and MUCONASAL PLUS.

In 2016 Slovaks returned 170 tons of unused/ expired drugs to 2,187 pharmacies, 65 tons more than in 2015. The largest quantity of drugs (26.47 tons) was returned in the Bratislava region.

In October 2016, due to massive re-export, Slovak pharmacies had very limited supplies of 2,644 different types of drugs (mostly drugs for cancer patients, patients with heart disorders, neurological problems, diabetic medicines, and medicines to be taken after surgery, such as Fraxiparine, Eliquis, Xarelto or Pradaxa). 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. The amendment set out a series of measures primarily aimed at preventing the export of drugs, as well as the removal of the measures for which the European Commission brought proceedings against the Slovak Republic. The new rules affected mostly pharmacies that were linked to the distributors (33 pharmacies had to be closed within the first two months since the amendment became effective, which is 30 percent more than last year). Pharmacies now need permission from the license holder to re-export drugs. Failure to adhere to the new amendment can result in fines from EUR 5 thousand (USD 5.3 thousand) to EUR 1 million (USD 1.06 million) and loss of distributor or pharmacy operating license.

The launch of the Diagnoses Related Groups (DRG) classification system remains Slovakia’s priority. The Slovak Minister of Health believes the DRG system could be fully implemented throughout 2017, after necessary amounts of economic data for evaluating are collected.

  • E-Health

e-Health by State - The National Health Information Center is preparing public procurement for support services to ensure eHealth’s fast and successful implementation, complete availability, and full functionality. The e-Health project was closed in 2015 and is currently in a pilot/testing phase. By the end of 2017 all doctors should be using e-Health. According to the current legislation, as of January 1, 2018, all health care providers are obliged to store patients’ data in their electronic health records. To date, the still not-fully-functional e-Health project contracts reached EUR 47 million (USD 49.8 million).

  • Hospitals

Under the auspices of Slovak Ministry of Health, there are 74 health care providers divided into three groups. While domestic and international experts believe 30 hospitals are optimal, the Slovak government plans to keep 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.). With fewer hospitals, greater demand will be placed on emergency rescue. In Slovakia, there are 273 ambulance stations - 92 are the “fast doctor’s help” with a doctor present and 181 are “fast rescue help” with a rescue crew. Average arrival time is eleven minutes. Rescue service is also conducted by seven helicopter ambulances.

Via multiple rounds, starting in autumn 2017 the Slovak Minister of Health plans to eliminate debts of both state and non-state hospitals by allocating EUR 585 million (USD 620 million) from state financial assets.

Though the Ministry fails to specify when the re-introduction of No.155 and No.112 phone consultations for patients with health complications will be launched, the idea is welcomed by experts who hope for reduction of number of patients coming to outpatients' departments.

In order to relieve the high-cost emergency departments and at the same time to motivate Slovak patients with less serious health problems to attend ambulatory care, the Ministry of Health plans to introduce higher fees by 500 percent as of 2018. (First Aid Medical Service fee will rise from EUR 1.99 (USD 2.10) to EUR 10 (USD 10.6)). Under the new emergency concept the Ministry of Health also plans to significantly change the network of outpatient emergencies (reduction by 16 to 79 - one per district) and to shorten their operating hours (emergencies should be opened till 11pm versus the current 24 hours).

Thirty years after the construction of the Bratislava hospital, Razsochy, began, the State has decided to complete the structure rather than leave it abandoned. The new university hospital should start operating in 2022 and is expected to have 600 beds serving people from all over Slovakia. The estimated cost is EUR 263 million (USD 279 million). The pre-announcement was published in the Office for Public Procurement journal as well as in the European Union procurement database.

Main Competitors

Slovakia’s medical device manufacturing sector is skilled, yet remains small; thus, most of the Slovak medical device market is dominated by imports, mainly from the U.S. and European Union markets. Around 88 percent of the medical device market is supplied by imports, of which Germany and the U.S. account for almost 50 percent.

Local producers focus a large part of their resources on export markets such as the Czech Republic, especially in dentistry. Domestic medical device production is estimated to be more than USD 300 million.

The biggest local pharma producers are Saneca Pharmaceuticals, Biotika, HBM Pharma, Imuna Pharm and Innopharma.

There are 284 companies (out of 294) selling pharmaceuticals that cover 43.7 percent of the local market. U.S. pharmaceutical companies, e.g. Abbott, Amgen, J&J, Merck and others, have a 30 percent market share. Based on 2015 sales revenue data published in November 2016, the largest pharmaceuticals companies in Slovakia are Sanofi-aventis Slovakia, Zentiva a.s., Johnson & Johnson, Roche Slovensko, GlaxoSmithKline Slovakia, Bayer, AbbVie, Teva Pharmaceuticals Slovakia and Merck.

The biggest licensed pharmaceutical distributors are Phoenix (38 percent market share) and Unipharma (30 percent market share), followed by Med-Art, Johnson & Johnson and Transmedic Slovakia. The full listing of license holders be viewed: http://www.health.gov.sk/Clanok?zasobovacie-organizacie-2016.

Plus Lekaren (Unipharma) with over 500, Partner (Phoenix) with 502, Vasa Lekaren (Med Art) with 248 and Druzstvo lekarni with approx. 100 pharmacies are the biggest independent pharmacy associations and virtual alliances. Dr. Max with 233 pharmacies and Farmakol with 55 pharmacies are two of the biggest pharmacy networks, followed by Sunpharma with 51 pharmacies, BENU with 50 pharmacies, Schneider with 24 and Ganatrade with 20 pharmacies.

Falck Zachranna with 150,000 annual departures, 1,400 employees, 107 rescue stations (32 emergency medical assistance stations and 75 emergency health care facilities) is the biggest player in the Slovak rescue market (39 percent market share). Besides ambulances, Falck, through 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 seventeen hospitals. Penta is with twelve 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.

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 standards 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. The Ministry of Health has already allocated EUR 153 million (USD 162 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 74 million). The second round is expected to be issued in 2018. By 2020, there are EUR 278 million (USD 295 million) available for drawing.

Registration Process

Please see Slovak State Institute for Drug Control for Slovakia’s potential registration specifics beyond European Union registration regulations and laws http://www.sukl.sk/en/registration-of-medicinal-product/scope-of-activities?page_id=4014.

Reimbursement

The health care debt remains a key concern in the Slovak health system. In February 2013, the maturity of supplier-consumer invoices was set by law to 60 days and in public sector to 30 days. In reality, hospitals fail to observe the law and the average maturity is 330 days. Some invoices are already 670 days overdue (versus 615 days in 2015). The factors which contribute to the situation that Slovak hospitals constantly increase debts are mainly strong connections between hospitals and government and 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. List of categorized medicines can be viewed: http://www.health.gov.sk/?zoznam-kategorizovanych-liekov . Drug price referencing is executed twice yearly and influences almost ¼ out of 4,500 drugs. More on categorized medical aids can be viewed http://www.health.gov.sk/?zoznam-kategorizovanych-zdravotnickych-pomocok.

Barriers

Based on the 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. Additionally, the younger generation is not interested in entering this sector due to low pay (current monthly salary is dependent on specialization and years worked, and ranges from EUR 695 (USD 737) to EUR 824 (USD 873)) or due to the workload (in some areas one nurse is responsible for thirty patients). The Minister of Health’s idea to switch from grade/years worked pay to performance pay has not yet been set by law. There are 5.8 Slovak nurses per 1000 inhabitants while the OECD average is 9.1. According to the Slovak Chamber of Nurses and Midwives, Slovakia is short by 12,000 nurses. The Ministry of Health claims however 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 project value of the contracting authority) to purchase via the Central Marketplace if the value of the goods, services or construction works exceeds EUR 5,000 (USD 5,300) excluding VAT and reaches maximum of EUR 134,000 (USD 142,000) excluding VAT for the State and EUR 207,000 (USD 219,420) excluding VAT for other contracting authorities. For construction projects, the ceiling is EUR 5,186,000 (USD 5,497,160) excluding VAT. All Slovak public tenders can also be found at the Portal for EU Tenders.

Local Associations

Slovak Dental Chamber

Slovak Association of Private Physicians

Slovak Union of Medical Specialists

Slovak Pharmacists Association

Slovak Association of Drugs and Medical Aids suppliers

Slovak Association Medical Aids suppliers

Slovak Hospital Association

Slovak Chamber of Nurses and Midwives

Trade Events

Name of event: SLOVMEDICA

Location: Incheba Expo Bratislava

Date: October 5-7, 2017

English website: http://www.incheba.sk/slovmedica-a-non-handicap-pre-vase-zdravie-8974.html?page_id=8974&lang=en

Description: SLOVMEDICA resents the latest medical techniques, technologies and equipment for experts active in the field of medicine, working in hospitals, nursing homes, as well as expert health education and science.

 

Name of event: NON HANDICAP

Location: Incheba Expo Bratislava

Date: October 5-7, 2017

English website: http://www.incheba.sk/vystavy/slovmedica-12695.html?page_id=12695&lang=en

Description: This year’s 19th annual specialized exhibition for handicapped people will host exhibitors promoting equipment and medical aids for the disabled.

 

Name of event: SLOVAK DENTAL DAYS

Location: Incheba Expo Bratislava

Date: September 21-22, 2017

English website: http://www.incheba.sk/vystavy/slovenske-dentalne-dni-12656.html?page_id=12656&lang=en

Description: Exhibition of dental instruments, tools and materials supported by

The Slovak Chamber of Dentists and Association of Dental Producers and Sellers remains the No.1 event for dental suppliers.

Government Links

Ministry of Health of the Slovak Republic

Statistical Office of the Slovak Republic

Slovak Dental Chamber

Ministry of Finance - Budget

Ministry of Finance

Office for Public Procurement

Best Prospects

 

2015

2016

2017 (Estimated)

2018 (Estimated)

Total Market Size

9,722,422

9,368,855

9,550,000

9,550,000

Total Local Production

7,619,125

7,259,000

7,500,000

7,500,000

Total Exports

769,306

659,740

650,000

650,000

Total Imports

2,872,603

2,769,595

2,700,000

2,700,000

Imports from the U.S.

41,531

49,000

50,000

50,000

Exchange Rate: 1 USD

0.837

0.91

0.903

0.940

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

The following specific items were the leading exports from the U.S. to Slovakia covered by this Leading Sector, ranked in USD from 2015 to 2016:

HS code

ITEM

2015

2016

9018

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

18,400,860

10,978,373

9031

Machines, Nesoi In Chapter 90; Profile Project, Pt

4,789,175

3,044,380

9013

Liquid Crystal Devices Nesoi; Lasers; Opt Appl; Pt

1,738,179

1,373,770

9027

Inst Etc For Physical Etc Anal Etc; Microtome; Pts

4,975,081

1,273,314

9021

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

606,683

782,771

9029

Revolution & Production Count, Taximeters Etc, Pts

738,293

775,183

9022

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

337,193

763,500

9026

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

2,934,416

684,079

9001

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

665,846

662,002

9002

Optical Elements, Mounted; Parts & Accessories

560,194

631,515

9030

Oscilloscopes, Spectrum Analyzers Etc, Parts Etc

947,760

490,153

9024

Machines Etc For Testing Mech Prop Of Material, Pt

2,015,898

273,491

9014

Direction Finding Compasses & Navig Inst Etc, Pts

70,048

239,500

9019

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

286,639

209,401

9033

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

90,288

196,092

9015

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

767,359

187,243

9028

Gas, Liquid Or Electric Supply Etc Meters, Parts

131,746

142,714

9032

Automatic Regulating Or Control Instruments; Parts

89,979

142,475

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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