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: 42.4 million

GDP (Purchasing Power Parity): US $ 337 Billion

Currency: Hryvnia

Language: Ukrainian, Russian

Summary

On January 1, 2018, healthcare reform laws became effective in Ukraine. This marks the first step in the transformation of the country's Soviet-era health system into a Western-style, health insurance-based system. This program will be launched on the primary medical care level starting from July 1, 2018. During the period of 2018-2019, it will cover certain other medical services, in specific healthcare institutions as a pilot project, and will be fully implemented on all levels of medical care beginning January 1, 2020. The reform will improve the operation of the health system, standardize prices for services across the country, provide patients with better access to treatment, improve the quality of services in medical institutions, and help end corruption prevalent in the medical sector.

The approved 2018 budget outlines an increase in public healthcare expenditure of $5.85 billion. The Ministry of Health projects gradual reduction in private healthcare contributions, which currently represent around half of total healthcare expenditures, with 94 % of these payments being paid out-of-pocket.

Over the coming years, as additional health services are incorporated into the National Healthcare Service, there should be a greater shift toward state-funded healthcare and away from the high reliance on out-of-pocket payments.

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, in local currency terms, over the 2018-2020 period.

In 2017, the Ukrainian medical device market was worth $374.8 million, and is projected to reach $405.8 in 2018. Multiple factors are driving the growth: new healthcare legislation, which changes the way healthcare is financed; the comprehensive hospital sector; the ongoing World Bank project approved in March 2015; and Ministry of Health plans to expand the network of clinics in rural areas.

In 2017, imports accounted for 88.6 % 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. share was about 12 % of total imports, and almost 25 % in orthopedics and prosthetics imports.

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 Government of Ukraine include strengthening primary healthcare, 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 –guaranteed benefit package in 2018 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 – 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 European Licenses in Ukraine.
  • Emergency Medical Care – settling the “Paramedic” educational program and special call-centers which nowadays experience 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 to involve more international and Ukrainian firms.
  • Reference Pricing and Reimbursement – currently covering cardiovascular diseases, type II diabetes and asthma; list of nosologies to be widened.
  • Public Health – establishing the Public Health Centers for prevention of diseases, vaccination and educational programs regarding diseases.

Main Competitors

In 2017, imports accounted for 88.6 % of medical device sales in Ukraine. Major suppliers are China, the U.S., Germany, and Japan. The U.S. share was about 12 % of total imports, and almost 25 % in orthopedics and prosthetics imports.

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 range of equipment including respiratory anesthetic equipment, hearing aids, radiology, electrocardiography & ultrasound machinery, refrigeration and cryogenic equipment, specialized medical furniture, orthopedic appliances, surgery and dentistry tools, sterilizing equipment, electrodiagnostic equipment and electrical stimulators. The range of domestically manufactured medical equipment remains limited, however, and the demand for expensive medical equipment is largely met by imports.

About 250 companies are developing and producing medical equipment in Ukraine. Domestic medical device production was worth over $72.7 million in 2017. Historically, exports tended to be largely at the lower end of the technology scale, but in 2017, diagnostic imaging exports accounted for nearly 40 % of the total. Around half of exports are destined for other former Soviet countries.

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 with technical regulations 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 U.S. Manufacturers should also be aware that Ukrainian regulations will require inspection of facilities even if those sites are already ISO 13485-compliant.

Documentation 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). 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 documentation expertise and sample examinations.

Reimbursement

The program of state guaranties of medical treatment for the public is being introduced in Ukraine within the healthcare reform launched from July 1, 2018. The list and scope of healthcare services, devices and medicinal products to be financed from the state budget and provided to patients free of charge will be adopted annually as part of the state budget.

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 2-4, 2018

English language website: http://www.publichealth.com.ua/en-GB/

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.

FAQs

1. Is the CE mark enough to export a medical device to Ukraine?

No. To export a medical device to Ukraine, the device, bearing a CE mark, needs to receive special symbol of national conformity. Conformity assessment procedure is conducted by an authorized body (see info above). Self-declaration is applied to Class I medical devices, not sterile.

2. What are the major sales channels in Ukraine?

There are two principal sales channels for medical devices served by diverse group of distributors, one for the hospitals/clinics and one for the pharmacies/orthopedic shops. Online sales channel for individual customers is developing.

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)
  • Laser surgery devices
  • Stents, pacemakers, and other equipment used in the treatment of heart conditions
  • Orthopedics and prosthetics
  • Dental equipment and materials

Market Size 2016

Healthcare spending (including investment)

USD 4.6 bn

... as percent of GDP

Est. 5%

Hospitals, Procedures, Healthcare Professionals 2016

Number of hospitals

1,745

…Public

1,612

…Private

133

Number of hospital beds

327,438

... available beds per capita (per 000 population)

7.4

Number of surgical procedures

2,955

Physicians

184,988

Nurses

303,672

Dentists

4,444

Demographics

Population (as of January 1, 2018)

42.4 million

Life expectancy men/women (2016)

69.1/77.5

Infant mortality (000 live births) (2016)

6.2

Percent of population older than 65 (est. 2017

23.2

Annual deaths [000 population; 2016)

13.1

...caused by [cardiovascular diseases; data 2012]

65.8%

...caused by [cancer; data 2012]

14.0%

Source: WHO, National Statistical Bodies, BMI


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