The South Eastern European country of Bulgaria spans over 111, 000 km2 and has a population of 7.6 million.
Bulgaria is well behind EU averages in terms of mortality and morbidity indicators. In 2009, the main three causes of death in Bulgaria were diseases of the circulatory system, malignant neoplasms and diseases of the respiratory system.
Bulgaria is a country in Southeast Europe. It lies on the Beastern flank of the Balkans, and is bordered by Romania to the north,Serbia and North Macedonia to the west, Greece and Turkey to the south, and the Black Sea to the east.
Bulgaria covers a territory of 110,994 square kilometers (42,855 sq mi), and is the sixteenth-largest country in Europe. Sofia is the nation’s capital and largest city; other major cities are Plovdiv, Varna and Burgas.
One of the earliest societies in the lands of modern-day Bulgaria was the Neolithic Karanovo culture, which dates back to 6,500 BC. In the 6th to 3rd century BC the region was a battleground for ancient Thracians, Persians, Celts and Macedonians; stability came when the Roman Empire conquered the region in AD 45. After the Roman state splintered, tribal invasions in the region resumed. Around the 6th century, these territories were settled by the early Slavs. Bulgars, a semi-nomadic people, invaded the Balkans in the late 7th century and founded the First Bulgarian Empire in AD 681. It dominated most of the Balkans and significantly influenced Slavic cultures by developing the Cyrillic script. The First Bulgarian Empire lasted until the early 11th century, when Byzantine emperor Basil II conquered and dismantled it. A successful Bulgarian revolt in 1185 established a Second Bulgarian Empire, which reached its apex under Ivan Asen II (1218–1241). After numerous exhausting wars and feudal strife, the empire disintegrated in 1396 and fell under Ottoman rule for nearly five centuries.
Healthcare in Bulgaria
Bulgaria’s main challenge is to catch up with the more developed Member States in terms of healthcare services. The reform process that began in the 1990s and continues today has yet to achieve its objectives. The major goal, and indeed challenge, is to improve population health. Success depends on improving competitiveness and structural reforms, particularly in the health system, to stimulate growth. This requires strong political support.
The South Eastern European country of Bulgaria spans over 111, 000 km2 and has a population of 7.6 million. Bulgaria is well behind EU averages in terms of mortality and morbidity indicators. In 2009, the main three causes of death in Bulgaria were diseases of the circulatory system, malignant neoplasms and diseases of the respiratory system.
The Ministry of Health is responsible for national health policy and the overall organization and functioning of the health system. The Bulgarian health system was reformed under the Health Insurance Act of 1998 into a health insurance system with compulsory and voluntary health insurance. The key players in the insurance system are the insured individuals, the healthcare providers and the third-party payers: the National Health Insurance Fund, the single payer in the social health insurance (SHI) system, and voluntary health insurance companies (VHICs).
The health insurance system covers diagnostic, treatment and rehabilitation services as well as medications for insured individuals and the Ministry of Health is responsible for public health services, emergency care, transplantations, transfusion haematology, tuberculosis treatment and inpatient mental healthcare.
Healthcare providers are autonomous self-governing organizations. The private sector includes all primary medical, dental and pharmaceutical care, most of the specialized outpatient care and some hospitals whereas the university hospitals and national centers, national specialized hospitals are run by the state. The state is also in charge of centers for emergency medical care, psychiatric hospitals, centers for transfusion haematology and dialysis, as well as 51% of the capital of regional hospitals.
Public private financing system
Bulgaria has a mixed public–private healthcare financing system. Healthcare is financed from compulsory health insurance contributions, taxes, out-of-pocket (OOP) payments, voluntary health insurance premiums, corporate payments, donations, and external funding. Total health expenditure as a share of gross domestic product (GDP) increased from 5.3% in 1995 to 7.3% in 2008. The structure of total health expenditure has been changing over time, with private expenditure increasing at the expense of public financing. In 2008, public expenditure on health as a share of total health expenditure was 57.8% while private expenditure accounted for 42.2%.
The main purchaser of health services is the National Health Insurance Fund (NHIF). Social health insurance contributions are calculated at 8% of monthly income, paid by the insured individuals, their employers, or the state. Relations between the NHIF and healthcare providers are based on the contract model. The Fund and the professional associations of physicians and dentists sign the National Framework Contract (NFC), which regulates the format and operational procedures of the compulsory health insurance system. Based on the NFC, providers sign individual contracts with the regional branches of the Fund. Providers are mainly paid prospectively for the services they will provide to the population on a fee- for service and per capita basis.
Voluntary health insurance is provided by for-profit, joint-stock companies in tended for voluntary health insurance only. Beyond the package covered by the NHIF all citizens are free to purchase different insurance packages. Voluntary health insurance companies can also cover the cost of services included in the basic benefit package guaranteed by the NHIF budget. Less than 3% of the population purchased some form of voluntary health insurance in 2010.
Medical services and organization
Outpatient services are organized according to territories. Investment for state and municipal health establishments is financed from the state or municipal share in the establishment’s capital. For local hospitals, municipality funding for new investment and maintenance costs has shown a downward trend. There are various programs offered by the Ministry of Health for investment in medical infrastructure that healthcare establishments can apply for. On the primary care level, there is an uneven distribution of GPs regionally and a lack of incentives for primary and specialized medical practices have led to increased use of specialized care and increased hospitalization rates. The number of acute beds per population in Bulgaria is above the EU27 average while the average length of stay is slightly below the EU27 and EU15 averages. Both indicators show a decreasing trend.
Health services are delivered by a network of various public and private healthcare providers. Public health services are provided by the state and organized and supervised by the Ministry of Health. The Health Care Establishment Act stipulates the distinction between outpatient and inpatient care.
The GP is the key figure in primary care and acts as a gatekeeper for specialized ambulatory and hospital care. The number of general practitioners in Bulgaria has been declining slowly and their geographical distribution does not reflect the needs of the population. Ambulatory care is also provided by specialized outpatient facilities, including individual and group practices, medical and medico-dental centers, diagnosticconsultative centers and stand-alone medico- diagnostic or medico-technical laboratories. They are autonomous healthcare establishments, most of them with a contractual relationship with the National Health Insurance Fund. All primary, and the majority of specialized, outpatient facilities are privately owned. Inpatient care is delivered mainly through a network of public and private hospitals, divided into multi-profile and specialized hospitals.
High rates of hospitalization indicate the underuse of ambulatory care and a lack of integration at the different levels of care. Healthcare reforms after 1989 focused predominantly on ambulatory care and the restructuring of the hospital sector is still pending on the government agenda. Thus, both an oversupply of acute care beds and an undersupply of long term care and rehabilitation services remain. Long-term care is generally underdeveloped regarding both community- based services and inpatient care provided by specialized hospitals. Regional centers for emergency care and hospitals’ emergency wards are the key units in the organization of emergency care. Urgent care is also provided by GPs. The main challenges faced in this field are the shortage of medical professionals and the lack of medical equipment.
In 2009 health workers accounted for 4.9% of the total workforce. While the number of physicians and dentists is high in Bulgaria, the number of nurses is well below the EU15, EU12 and EU27 averages. Healthcare professional mobility is a growing concern in B u l g a r i a , m a i n l y d u e t o t h e d e v e l o p m e n t o f t e c h n o l o g y , a c c e s s i b l e t r a n s p o r t a n d communications. The migration of medical specialists has become a serious challenge: during the first nine months of 2010, more than 340 physicians and 500 nurses left the country.
In terms of education and training, medical education is provided by four medical universities and two medical faculties in other universities. The Council of Ministers determines the requirements for obtaining both higher education degrees and s p e c i a l i z a t i o n s . P r o f e s s i o n a l specialties in health provision are determined by the Ministry of Health and require a state examination by the State Examination Commission in Sofia. Continuous medical education is organised and credited by the P r o f e s s i o n a l A s s o c i a t i o n s i n accordance with the Health Act.
There have been three stages of reform of the healthcare system in Bulgaria since 1989. The first stage of r e f o r m ( 1 9 8 9 – 1 9 9 6 ) s a w t h e abolishment of the state monopoly in the health system and the building a decentralized healthcare administration. During this period the idea of a health insurance system also emerged. The second stage (1997– 2001) saw the introduction of the new health insurance system with new laws on health insurance, healthcare establishments and the professional organizations of physicians and dentists. In the third stage (2002–present), the legislative foundation of the healthcare reform was completed. This third stage focuses on decreasing the number of citizens without SHI coverage and securing the financial stability of the system (mainly by raising the health insurance contribution from 6% to 8%).
At the present moment, these reforms have yet to achieve their main objectives: improved population health and a democratic healthcare system that meets the health needs of the population.
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.
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 US. Market growth will be dependent upon increasing healthcare funding and the success of efforts to develop the private sector.
There is a strong US 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). US enterprises have approximately 50% market share and are continuing to support operations in Bulgaria. The main competitors are German, Swiss and French CROs.