Please visit our new website at www.export.gov!

Healthcare Resource Guide: Ukraine

Ukraine Statistics


Bestand:Flag of Ukraine.svg

Summary

Market Entry

Current Market Trends

Main Competitors

Current Demand
Registration Process

Reimbursement

Barriers
Procurement and Tenders

Trade Events

CS Contacts
Best Prospects

Capital: Kyiv

Population: 42.6 million

GDP (Purchasing Power Parity): int. $352.6 billion

(2016 estimate)

Currency: Hryvnia

Language: Ukrainian, Russian

Summary

Local tax revenues are the primary source of funding for healthcare in Ukraine. Ambulatory and hospital services are provided predominately by facilities at the regional, district or municipal levels. Healthcare expenditures in Ukraine were $4.7 billion in 2016 and are projected increase by 4.1 percent in 2017 in local currency terms (-2.3 percent in US dollar terms). Private expenditures represent around half of total health care expenditures, and 94 percent of these payments are paid out-of-pocket.

In April 2017, Ukraine's Cabinet of Ministers approved a legislative package for healthcare system reform. These laws are now under consideration by Parliament. If the package is adopted, it will take three years to launch the new healthcare system fully. Under this new system, a new health insurance system would cover a broad range of services, while a new national purchasing agency will help prevent corruption in the healthcare system.

There is no accurate statistical data on the size of the Ukrainian medical equipment market. According to the BMI forecast, the Ukrainian medical device market will record double-digit growth over the 2015-2018 period, expanding moderately in U.S. dollar terms due to local currency depreciation. In 2016, the Ukrainian medical device market was worth $288 million, a 3.7 percent increase over 2015. Multiple factors are driving growth: extra funding allocated for the purchase of cardiology equipment in the 2017 national budget; an ongoing World Bank project approved in March 2015; Japanese grants for modernization of medical equipment at several hospitals; the Ministry of Health's plans to expand the network of clinics in rural areas; and the need to rebuild or re-equip healthcare facilities that were destroyed during the conflict in eastern Ukraine.

Imports account for 90 percent of medical device sales in Ukraine. Major trade partners in this segment include:

U.S. - particularly strong in the supply of orthopedics and prosthetics, and diagnostic imaging equipment

China - strong in the supply of consumables and patient aids

Germany – the leader in dental imports

Japan – strong in imaging equipment imports

The U.S. was the second leading supplier (after China) in 2016, with imports worth $32.8 million, or 12.6 percent of total sales. The U.S. accounted for almost 25 percent of orthopedics and prosthetics sales.

The Ukrainian market is open to advanced medical equipment, offering ease of use and cost savings. Receptivity to used medical equipment is average. On one hand, there is a demand from end-users, but on the other hand, used equipment cannot be purchased through government tenders. However, private hospitals and clinics are in the market for used medical equipment.

Market Trends

U.S. companies entering the Ukrainian market should approach the market with a long-term perspective. Business in Ukraine is often based on relationships, so selecting a good local partner and/or establishing a local office are crucial to minimizing risk and long-term success. To find a potential partner, we recommend using the U.S. Commercial Service’s International Partner Search and/or Gold Key programs to conduct initial screening for prospective partners. (For more information please refer http://www.export.gov/ukraine ) U.S. companies should use appropriate due diligence in selection of partners and should be mindful of the parameters of the Foreign Corrupt Practices Act.

Kyiv is not the only trade hub in Ukraine. Look for distributors that have nationwide capabilities, including those located in the cities of Dnipro, Lviv, Odessa, Zaporizhzhya, and Kharkiv. These regions are considered important industrial centers in Ukraine and are densely populated. Covering the Ukrainian market from regional offices in Poland or Russia is not an effective approach. Ukrainian buyers are reluctant to go through regional offices, preferring to order direct for the manufacturer/wholesaler. On-the-ground presence is very important to successful business development in Ukraine.

Joining the American Chamber of Commerce and obtaining experienced legal and accounting support are other important considerations when considering doing business in Ukraine.

Current Market Trends

Public health priorities as announced by the GOU include strengthening primary health care, optimizing the number and the structure of hospitals in Ukraine, responding to disease outbreaks, providing vaccinations, diagnosing health threats, providing water and food safety, and providing a safe living environment.

In this context, the Ministry of Health is highlighting ten key healthcare reform priorities:

  • New Financing System – reforming the primary care system in 2017 (according to the package of draft laws, guaranteed benefit package includes primary care, palliative care, and urgency care);
  • eHealth System – IT solution for ensuring that Government gathers accurate statistical information through patients’ and doctors’ registries;
  • Hospital Districts – guaranteeing that the healthcare system is available for patients in every settlement;
  • Quality of Care – The National Health Service will require doctors to use the international standards of treatment;
  • Medical Education System – improving the quality of doctors within standardized examination programs, recognizing the European Licenses in Ukraine;
  • Emergency Medical Care – settling the “Paramedic” educational program and special call-centers while nowadays there is a high level of inappropriate use of ambulance hot line;
  • National Blood System – establishing the National Blood System for the universal access to safe blood for Ukrainian citizens;
  • Procurement – establishing the National Procurement Agency for involving more international and Ukrainian firms;
  • Reference Pricing and Reimbursement – currently covering cardiovascular diseases, Type II diabetes and asthma, list of nosologies to be widen;
  • Public Health – establishing the Public Health Centers for prevention of diseases, vaccination and educational programs regarding diseases.

Main Competitors

Though Ukraine has a strong scientific research base, capable of developing highly advanced treatments and products, it lacks an accompanying strong manufacturing sector. Domestic manufacturers produce a limited range of equipment including radiology, electrocardiography and ultrasound machinery, refrigeration and cryogenic equipment, specialized medical furniture, orthopedic appliances, respiratory anesthetic equipment, hearing aids, surgery and dentistry tools, sterilizing equipment, electro-diagnostic equipment, and electrical stimulators.

About 250 companies are developing and producing medical equipment in Ukraine. Domestic medical device production was worth over $57.9 million in 2016. Historically, exports tended to be largely at the lower end of the technology scale, but in 2016, diagnostic imaging exports accounted for nearly 40 percent of the total. Around half of exports are destined for other former Soviet countries.

As indicated, imports account for 90 percent of medical device sales in Ukraine. The major suppliers are China, the U.S., Germany, and Japan. The U.S. was the second leading supplier in 2016 (after China), with imports worth $32.8 million, or 12.6 percent of total sales.

Current Demand

  • Diagnostic imaging equipment (ultrasound, computer tomography, magnetic-resonance tomography)
  • Emergency medical equipment (ambulances, mobile hospitals)
  • Orthopedics and prosthetics
  • Surgical navigation systems
  • Laser surgery devices
  • Implantable cardiac devices, neurostimulation systems
  • Dental equipment and materials
  • Laboratory equipment, diagnostic point-of-care tests
  • Modern equipment offering ease of use and cost savings is required in the fields of micro-surgery, radiology and bio-medicine.

Registration Process

Ukraine is moving towards harmonization with EU standards in the field of medical equipment/devices. In July 2015, a new national conformity assessment procedure governing the registration of medical devices was introduced. New products can enter the Ukrainian medical device market if they conform to the technical regulations, which are based on the EU Directives for medical devices. The new system introduces the following requirements for Ukrainian medical device registrations:

  • Foreign registrants must appoint Authorized Representatives based in Ukraine
  • Expanded list of documentation and sample submissions required for registrations
  • Manufacturing site inspections for Classes I, IIa, IIb and III
  • Special symbols of national conformity are required for medical devices imported into Ukraine
  • National conformity certifications are valid for five years

Although the new Ukrainian registration system bears many similarities to the CE Marking process for medical devices in Europe, no simplified or expedited market pathways are planned for devices already approved or cleared for sale in major markets such as Europe or the US. Manufacturers should also be aware that Ukrainian regulations will require inspection of facilities, even if those sites are already ISO 13485-compliant.

Documentary expertise, on-site manufacturing inspections and testing of samples of medical devices is being performed by national authorized bodies (analogue of notified bodies in EU). A list of state and private bodies that have been granted accreditation from the National Accreditation Administration of Ukraine and the Ministry of Economic Development and Trade can be found at http://www.moz.gov.ua/docfiles/an_20150724_0_dod2.pdf (in Ukrainian)

Self-declaration is applied to:

  • Class I medical devices, not sterile, without measuring functions (as defined by provisions in the technical regulation on medical devices (Decree of CMU №753);
  • Analyzers, reagents, and other IVD products, which are not included in the lists “A” and “B” in the technical regulations on in-vitro diagnostic medical devices (Decree of CMU №754);

Conformity assessment involving authorized body is required for:

  • Class I sterile medical devices, measuring medical devices, all medical devices of classes IIa, IIb, III according to provisions in the technical regulation on medical devices (Decree of CMU №753);
  • In-vitro: self-testing devices; reagents, calibration, and control materials of lists “A” and “B” in the technical regulations on in-vitro diagnostic medical devices (Decree of CMU №754);
  • All active implantable medical devices according to the technical regulations on active implantable medical devices (Decree of CMU №754);

The conformity assessment procedure with the involvement of an authorized body may be conducted using one of the following routes:

1. In form of assessment of the Quality Management System at the manufacturing site (the on-site inspection), which results in issuing of the conformity certificate for medical devices valid for 5 years related to the quality management certificate valid for 3 years.

2. In form of conformity assessment of each batch, which implies issuing of the certificate for the certain batch (shipment) of medical devices after documentary expertise and sample examinations.

Reimbursement

In April 2017, the Cabinet of Ministers of Ukraine approved a package of four bills on healthcare system reform, which is to be considered by Parliament. A major part of the healthcare reform revolves around the long-awaited introduction of a public health insurance system. The MOH plans to implement it over a three-year period, creating a system that would finance primary care by mid-2017, secondary care by 2018 and tertiary care by 2019.

Acting Health Minister Ulana Suprun noted that the MOH will set the tariffs for secondary-level medical services using a Diagnostic Related Groups (DRG) system. The government is currently determining the minimum group of health services that will be available to all patients under the insurance system. Patients will need to make co-payments for specialized treatments, complex or expensive surgeries or specific types of therapy.

The current healthcare system is largely funded by general government revenues raised through taxation. Ukrainian citizens are entitled to a comprehensive guaranteed package of healthcare services, provided free of charge at the point of use in public healthcare facilities: emergency care; outpatient polyclinic care; inpatient care for acute conditions and emergencies requiring intensive treatment and first aid for the rural population. However, in practice, patients need to pay out of pocket to access services due to insufficient government financing of the health system. Private expenditure represents around half of total healthcare expenditure, and 94% of this consists of out-of-pocket payment.

Barriers

Although the new Ukrainian registration system will bear many similarities to the CE Marking process for medical devices in Europe, no simplified or expedited market pathways are available for devices already approved or cleared for sale in major markets such as Europe or the U.S. Manufacturers should also be aware that Ukrainian regulations will require inspection of facilities even if those sites are already ISO 13485-compliant.

According to current regulations, government tenders are to be non-discriminatory against foreign bidders.

Procurement and Tenders

Ukraine’s implementation of an e-procurement system in August 2016 presents opportunities for American companies to participate in Ukrainian public tenders.

American suppliers interested in current public procurement opportunities in Ukraine may register for notifications at the Ukrainian Public Procurements Official National Web Portal PROZORRO: https://tender.me.gov.ua/EDZFrontOffice/ and at the PROZORRO website http://prozorro.org/.

Trade Events

Name of event: Public Health

Location: Kyiv, the International Exhibition Center

Dates: October 3-5, 2017

English language website: http://www.publichealth.com.ua/eng/index.php

Description: Public Health is a medical equipment (including dental, clinical laboratory and optical) and pharmaceuticals trade show in Ukraine. Public Health is held annually in October. The show organizer for Public Health is Premier Expo, a part of the International Trade Exhibitions Group, UK.

U.S. Commercial Service Contact Information

Name: Olena Stephanska,

Position: Commercial Specialist

Email: olena.stephanska@trade.gov

Phone: 380-44-5215387

Best Prospects

  • Diagnostic imaging equipment (ultrasound, computer tomography, magnetic-resonance tomography) – ongoing World Bank project provides financing for medical infrastructure aimed at the prevention and early detection of chronic diseases and cancer
  • Stents, pacemakers, and other equipment used in the treatment of heart conditions - additional USD 5.7million allocated for the purchase of cardiology equipment in the 2017 state budget
  • Orthopedics & prosthetics, Dental equipment and materials are in high demand

Healthcare spending (including investment)

 

... as percent of GDP

5.04% (2016 est); 7.1% (2014)

Hospitals, Procedures, Healthcare Professionals UN:

Number of hospitals

1,700 (2016)

Number of hospital beds

315,000 (2016)

... available beds per capita

7.43 per 1000 inhabitants

Number of surgical procedures

2,973,790 (2016 est.)

Physicians

213,477 (2016 est.)

Dentists

26,954

Demographics

Population

42,584,542 (as of January 1, 2017)

Life expectancy men/women

  • male: 66.4 years
  • female: 76.3 years (2015)

Infant mortality

7.4 deaths/1,000 live births

Percent of population older than 65

15% (2016)

Annual deaths

14.7 deaths/1,000 population (2016)

...caused by [highest disease burden]

Heart and Vascular Diseases

...caused by [second highest]

Cancer

Prevalence of Heart and Vascular diseases

68%


  Notice to Visitors!


  The link you have chosen will take you to a non-U.S. Government website.

  If the page does not appear in 5 seconds, please click this: outside web site

  Export.gov is managed by the International Trade Administration and external links are covered by its website  disclaimer statement.


  Notice to Visitors!


  The link you have chosen will take you to a non-U.S. Government website.

  If the page does not appear in 5 seconds, please click this: outside web site

  BuyUSA.gov is managed by the International Trade Administration and external links are covered by its website disclaimer statement.