Executive Summary
Bulgaria’s healthcare sector is funded principally through the compulsory health insurance system operated by the Bulgarian Health Insurance Fund (Fund) The Fund collects contributions from the working population and the government makes payments on behalf of those exempt, such as the elderly, the unemployed, and dependents. Based on data from the World Health Organization (WHO), Bulgaria spent approximately 8.2% of its GDP on healthcare in 2018, equating to $5.3 billion, or $755 per capita.
The Ministry of Health (MoH) is committed to achieving a national pathway for development of the healthcare system, guaranteeing health welfare, high quality of life, and reducing health inequalities through a comprehensive, fair, sustainable health system. The healthcare industry has excellent opportunities for advancement and improvement. The market for both pharmaceuticals and medical equipment will continue to grow and evolve, as it meets European Union (EU) quality standards and grows imports.
Market Entry
The Bulgarian market is highly reliant on imports in the healthcare sector. United States (U.S.) exporters are encouraged to refer to the applicable EU legislation and its directives. U.S. companies must comply with the national legislation as well and go through compliance procedures depending on the classification of the products. In addition, they must appoint an EU-based authorized representative to be successful in the respective market.
Current Market Trends
Pharmaceuticals:
In 2018 the Bulgarian pharmaceutical market grew by 5.9% (compared to 11% in 2017), reaching $2.0 billion and outpacing other fast-growing markets in the Central and Eastern Europe region. Nevertheless, this was the first registered decrease in growth, which has been in double digits for the last ten years. In 2018, approximately 3% of Bulgaria’s GDP was spent on pharmaceuticals, well above the historical average. A boost to hospital spending on innovative drugs was a key driver of market growth, but this was primarily due to a backlog of demand for innovative medicines.
Medical Devices:
Bulgaria represents one of the smallest medical device markets in the EU, which will register a mid-single-digit local currency compound annual growth rate over the 2018-2023 period. The market is largely reliant upon imports, which are primarily sourced from other EU member states and the U.S. Market growth will be dependent upon increasing healthcare funding and the success of efforts to develop the private sector.
Health IT:
There is a strong U.S. presence providing healthcare solutions for the med-tech industry. Excellent mobile and internet networks are available in the country, with high penetration rates, which makes the market very friendly and open to innovation and digital technologies. There is, however, intense competition, mainly from German and Chinese providers competing on price and delivery. The National Health Insurance Fund (NHIF) administers the resources collected from the mandatory health insurance contributions. Bulgaria’s e-health sector reform strategy encourages modernization and upgrades in a wide range of areas including the demand for telemedicine and introduction of a national healthcare portal.
R&D and Clinical Trials:
Bulgaria ranks among the top 20 in the world in clinical trials performed, a field valued at $150 million. Bulgaria offers great potential for Contract Research Organizations (CROs). U.S. enterprises have approximately 50% market share and are continuing to support operations in Bulgaria. The main competitors are German, Swiss and French CROs.
Best Prospects
The Bulgarian market provides an opportunity to explore more established markets, with export potential in Western Europe, Russia and the Middle East. Key opportunities include:
- E-Health/m-Health technologies, services and solutions (e-prescription, e-appointments, etc. including development of software)
- New drugs and biosimilars (branded and generics) for oncology, diabetes, and cardiology
- Food and nutrition supplements, vitamins, probiotics, and health cosmetics
- Pharmacy automation, software and services
- R&D and clinical trials (some 230 clinical trials are registered in Bulgaria annually); Central and Eastern Europe account for 13.6% of the market of Phase III clinical trials
Market Size
Healthcare Spending (including investment)
|
Healthcare spending (including investment)
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US $4.24B
|
|
… as percent of GDP
|
8.2%
|
|
… of which spent on inpatient services (including long-term care)
|
US $0.7M
|
|
… of which spent on pharmaceuticals/consumables
|
US $1.78M
|
Hospitals, Procedures, Healthcare Professionals UN:
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Number of hospitals
|
346
|
|
…Public
|
193
|
|
…Private
|
153
|
|
Number of hospital beds
|
53,173
|
|
… available beds per capita (per 000 population)
|
7,8
|
|
…of which in general hospitals
|
37,489
|
|
…of which in specialized clinics and rehabilitation centers
|
13,438
|
|
Number of surgical procedures
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2,060,415
|
|
…of which [Caesarian section]
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193,677
|
|
…of which [Cataract surgery]
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71,950
|
|
Physicians
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29,667
|
|
…of which surgeons
|
1,576
|
|
…of which internists
|
965
|
|
…of which pediatricians
|
1,735
|
|
Dentists
|
8,011
|
Demographics 2017
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Population
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6.9 million
|
|
Life expectancy men/women
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71.4/ 78.2 years
|
|
Infant mortality (000 live births)
|
7.5
|
|
Percent of population older than 65
|
21%
|
|
…projection, 2030
|
23.3%
|
|
Annual deaths (per 000 population)
|
15.5%
|
|
…caused by [Heart Disease]
|
70, 546
|
|
…caused by [Cancer]
|
17,329
|
|
Prevalence of [Digestive system diseases]
|
2% growth
|
Data sources: NSI, CIA World Factbook, Eurostat, World Bank, WHO
Main Competitors
Medical laboratory equipment, tools, instruments, consumables and services have an important role in Bulgaria, where about 200 foreign companies (agents, distributors, representative offices) operate – but where there is still room for a wide range of excellent U.S. products and services. For example, according to the leading distributors, 98% of all total dental equipment is imported, with 71% of it from European suppliers and 28% from U.S. dental suppliers/manufacturers. The main competitors are German, Italian, Swiss, French and Chinese suppliers.
Current Demand
In 2018, a boost to hospital spending on innovative drugs was a key driver of market growth, but this was primarily due to a backlog of demand for innovative medicines. Future growth should be stimulated by the rising demand for generic medicines, although the prospects for the launch of novel medicines appear considerably less favorable. Furthermore, Bulgaria’s aging population will become increasingly apparent over the next ten years, as demand for healthcare and healthcare services rises. Healthcare spending is expected to grow at a compound annual growth rate of 5.2% in local currency terms and 5.6% in US dollar terms to a value of $8.36 billion in 2027.
Registration Process
There are no restrictions on sales and import of new and refurbished medical devices in Bulgaria. The medical equipment must meet the European certification requirements and have the CE mark. Duties and taxes are applicable at the same rates to both new and refurbished equipment. The key end-user groups for the refurbished category are private hospitals, clinics, and specialized ambulatory care segments.
Reimbursement
The health-insured person is obliged to pay their health insurance contributions according to the respective procedure, and within the deadlines specified in the Health Insurance Act; otherwise, they lose health insurance rights, which are reimbursed upon payment of the due amounts. The MoH and the National Health Insurance Fund administer the reimbursement of medicinal product costs, and reimbursement costs are covered by the National Health Insurance Fund. The list is put together by the agency and is updated annually.
Barriers
Bulgaria is a relatively open market, but certain administrative and procedural requirements can become non-tariff trade barriers. Poor Intellectual Property protection and the need for greater transparency and predictability in the regulatory environment are common market access issues for U.S. firms. For this reason, a vetted, experienced agent/distributor or representative is essential in Bulgaria.
Procurement & Tenders
Under Bulgaria’s procurement law, a government procurement agency was established which reports to the Minister of Economy. The Public Procurement Agency ensures and monitors the implementation of the state’s public procurement policy: www.aop.bg.
Tenders issued by Bulgaria’s public contracting authorities for projects supported by EU grants are subject to EU public procurement legislation if they meet the EU minimum contract value requirement for the eligible sector. There are no overt rules prohibiting the participation of U.S. companies as developers or concessionaires of projects partially supported by the European Social Fund (ESF), or as bidders on subsequent public tenders related to such projects, since they will be working with a local partner to tap into EU financial support.
For information on the EU-financed public tenders see: http://export.gov/europeanunion/marketresearch/eufundingandgovernmentprocurementsectors/index.asp
Frequently Asked Questions
1. What are the certificates, other than the CE mark, needed to register medical devices in Bulgaria?
There are several types of medical devices that should be registered in Bulgaria. Registration guarantees that the device can be placed on the market and ensure that it is safe for the patients. The devices should be registered electronically via the platform of the Bulgarian Drug Agency by the manufacturer/agent, representative or importer. There are six documents needed for the registration: a certificate from the Registry Agency, invoice for paid fee, certificate for quality, certificate from the manufacturer, valid EU certificate, and instructions in Bulgarian.
2. What documentation and databases should hospitals and specialized clinics have, according to the General Data Protection Regulation (GDPR)?
GDPR obliges anyone who processes personal data to maintain a register of content detailed in Art. 30 of the Regulation. The requirement for a register also applies to healthcare facilities with less than 250 employees, because they process a special category of data. It is required to specify the purposes for which the data is handled, and if multiple different purposes are indicated, it is advisable to allow the individual to express a separate agreement for each of them.
U.S. Commercial Service Contact Information
Name: Milko Minev
Position: Commercial Specialist/ Outreach Coordinator
Email: milko.minev@trade.gov
Phone: +359-2-937-5145
