Health legislation in Bulgaria - Comprehensive overview

This document provides a comprehensive overview of the Health Act, the Health Insurance Act in Bulgaria, and the medical establishment act, detailing the legal framework governing health care, insurance, and medical practices in the country.

The Health Act, the Health Insurance Act, and the Medical Establishments Act collectively form the cornerstone of Bulgaria’s healthcare legislation. Together, these acts provide a comprehensive legal framework that governs the organization, management, and delivery of healthcare services in the country. They ensure that healthcare is accessible, high-quality, and regulated, while also addressing the rights and responsibilities of patients and healthcare providers. The Health Act is the foundational piece of legislation that outlines the principles, rights, and obligations related to healthcare in Bulgaria. It establishes the national healthcare system, defines health establishments, and sets up state health control mechanisms. The Act emphasizes the importance of health promotion, disease prevention, and the protection of vulnerable groups such as children, pregnant women, and individuals with disabilities. It also introduces the National Health Information System, which aims to ensure the timeliness and accuracy of health data, providing a suitable environment for data exchange and ensuring information security. The Health Insurance Act focuses on the financial aspects of healthcare, detailing the compulsory and voluntary health insurance systems in Bulgaria. The National Health Insurance Fund (NHIF) plays a central role in managing compulsory health insurance, ensuring that a wide range of medical services are covered. The Act also outlines the National Framework Agreement (NFA), which sets the terms and conditions for medical and dental activities funded by the NHIF. Voluntary health insurance is regulated to provide additional coverage options beyond the compulsory system, with licensed insurance companies offering these services. The Act includes provisions for cross-border healthcare, allowing Bulgarian citizens to access medical services in other EU Member States and receive reimbursement for these services. The Medical Establishments Act regulates the organization, management, and operation of medical establishments in Bulgaria. It defines the types of medical establishments, their functions, and the legal framework for their operation. The Act ensures that medical establishments adhere to medical standards and good practice rules, providing high-quality healthcare services. It also outlines the process for registering and obtaining permits for medical establishments, ensuring that they meet the necessary requirements before beginning operations. The Act includes provisions for the management and control of medical establishments, the roles and responsibilities of healthcare personnel, and the financing of medical services.

Health Act

The Health Act is a comprehensive legislative framework that governs the health care system in Bulgaria. It outlines the principles, rights, and obligations related to health care, health insurance, and the medical profession. This act follows the Constitution of the Republic of Bulgaria and is designed to ensure the health and well-being of citizens.

Chapter I

Chapter one of the Health Act lays the foundation for the national system of health care by outlining general provisions, defining health establishments, establishing state health control mechanisms, addressing health information and documentation, and introducing the National Health Information System.

Section I. General Provisions

The General Provisions, establishes that this Act governs public relations concerning the preservation of citizens’ health. It declares that the preservation of citizens’ health as a state of complete physical, psychic, and social welfare is a national priority guaranteed by the state. This guarantee is implemented through several key principles, including equality in using health services, providing accessible and qualitative health care with priority of health promotion and disease prevention, special health protection for vulnerable groups such as children, pregnant women, new mothers, disabled, and mentally disordered people, and state participation in financing activities aimed at preserving citizens’ health.

The Minister of Health is required to present an annual report on the health status of citizens and the fulfillment of the National Health Strategy to the National Assembly three months before the start of the budget year. Furthermore, the Minister of Health approves the allocation of state budget subsidies for activities covered by this Act, with certain exceptions for medical and dental practice and pharmaceutical practice.

Section II. Health Establishments

Section II defines health establishments, outlining that these are establishments where medical and non-medical specialists carry out activities related to the preservation and building-up of citizens’ health. Specifically, the Act lists several types of health establishments, including national centers for public health, the National Expert Medical Commission (NEMC), health consulting rooms (at schools), and optics. Pharmacies are also considered health establishments, but their status and activities are governed by the Medicinal Products In The Human Medicine Act.

• The national centers for public health problems are tasked with activities such as studies, assessments, expertise, analyses, and prognoses in public health, prevention and control of infectious disease epidemics, organizing and coordinating medical care during disasters, risk assessment of environmental factors on health, laboratory tests and expertise, protection against ionizing and non-ionizing radiation, health promotion and disease prevention, expert assistance to regional health inspections, planning and implementing scientific activities, state health control in legally stipulated cases, and collecting and analyzing health information.
• Optics are defined by their activities, which include health consultations for sight problems by qualified physicians, undertaking measures for sight correction prescribed by a physician, and the making and sale of eyeglasses and optical materials.

Section III: State Health Control

Section III addresses state health control, stating that it is carried out to preserve the health of citizens throughout the Republic of Bulgaria. The bodies responsible for state health control are the chief health inspector of the Republic of Bulgaria, the regional health inspections, and the National Centre for radiobiology and radiation protection (NCRRP). The chief state health inspector organizes and manages state health control activities, health promotion and integrated disease prevention, and prophylactic and anti-epidemic measures during calamities and accidents. The chief state health inspector also has the authority to issue obligatory prescriptions for addressing non-compliance with health requirements, to propose the rejection of acceptance of public purpose constructions with essential violations of standards, and to place certifying signs in specific cases.

Section IV. Health Information and Documentation

Section V focuses on health information and documentation, defining health information as personal data related to health status, physical and psychological development, as well as information in medical prescriptions, records, certificates, and other medical documentation. Medical and health establishments, regional health inspections, physicians, dentists, pharmacists, other medical specialists, and non-medical specialists working in the national health system are responsible for gathering, processing, using, and storing health information. The forms, content, terms, and order of processing, using, and storing medical documentation and for exchanging medical statistical information are determined by ordinances of the Minister of Health.

Health information can be submitted to third parties under specific circumstances, such as for continued therapy, danger to others, identification of a deceased person, state health control needs for epidemic prevention, medical expertise and public insurance, medical statistics or research (with anonymized data), and the needs of the Ministry of Health, National Centre for Health Information, NHIF, regional health inspections, and the National Institute of Statistics. The submission of information generally requires notification of the concerned person. All entities handling health information are obligated to protect it against unauthorized access. Patients have the right to access their health information, including copies of medical certificates, and can authorize another person to review their medical certificates. Heirs and close relatives of a deceased patient also have the right to review the decedent’s medical file and obtain copies of medical certificates. Medical professionals are prohibited from disclosing patient information obtained during their official duties.

Section V. National Health Information System

Section VI introduces the National Health Information System (NHIS), established, administered, and maintained by the Ministry of Health. This system is based on principles of timeliness and accuracy of data, providing a suitable data exchange environment, ensuring regulated access in compliance with the law, and ensuring interoperability and information security. The system gathers, processes, and stores information on various aspects of health care. For the needs of this system, data from the Population Register is provided free of charge. Medical and healthcare establishments are required to submit information to the Ministry of Health for the creation and maintenance of electronic health records, with the type, manner, conditions, and procedure for providing this information to be determined by an ordinance of the Minister of Health. Citizens have the right to free access to their electronic health records within the National Health Information System, and medical and health establishments, the National Health Insurance Fund, insurance companies, and state bodies have access in connection with their functions or as provided by law. However, access to electronic health records for these entities is generally allowed only after explicit written consent.

Chapter II

Chapter two of the Health Act details the activities aimed at the preservation of the health of citizens, encompassing a wide range of public health responsibilities and regulations.

Section I. General Provisions

Section I, General Provisions, establishes that state bodies and institutions are responsible for planning, developing, and conducting policies directed towards preserving citizen health by ensuring a healthy living environment, promoting education on a healthy lifestyle, and implementing health prophylactics. Municipalities can be assisted by health mediators in carrying out policies related to health prophylaxis, and doctors may also receive assistance in connection with the medical assistance they provide. Corporate bodies and individuals are obligated to adhere to established health requirements in their operations.

Section II. Ensuring of healthy living environment

Section II outlines the health requirements for sites with public designation and for activities of importance for human health. The Minister of Health manages the national system for analyzing, assessing, and controlling noise in urbanized areas and public buildings, as well as pollutants in drinking water. The Minister also analyzes and assesses environmental health factors at a national level in the annual report and proposes measures to limit their harmful impact. Individuals and legal entities intending to operate sites with public designation, introduce new activities, or change the purpose of existing ones, where these could affect citizens’ health, must notify the territorial bodies of the state health control. Within one month of notification, these bodies conduct checks for compliance with health requirements. Regional health inspections create and maintain public registers of sites with public designation, according to an ordinance by the Minister of Health.

This section also concerns the issuance of health certificates. Upon request from interested parties, the chief state health inspector issues health certificates for the export of domestically manufactured products and goods of importance for human health, certifying their compliance with national legislation and free distribution within the country. Applicants must submit a request indicating their details, the destination country, the justification for the certificate, and specific information for cosmetic products, such as the European Commission notification reference.

Section III. State Health Control over Cosmetic Products

Section III addresses state health control over cosmetic products. Cosmetic products placed on the market are considered safe if they comply with good manufacturing practices, have undergone safety assessments, meet the requirements for the product information file (accessible in Bulgarian if kept in Bulgaria), adhere to restrictions for specific substances, meet labeling requirements (with certain information also displayed in Bulgarian), comply with product claim regulations, and meet requirements for public access to information.

Section IV. Health Promotion and Disease Prevention

Section IV focuses on activities for restricting the use of tobacco and related products, the abuse of alcohol, and preventing the use of narcotic substances. The state implements promotional and prophylactic activities and ensures access to medical help and social protection for affected individuals. These activities are carried out through national programs aimed at restricting the use of tobacco and related products, alcohol abuse, and preventing narcotic substance use, as well as prohibiting the use of nitrous oxide (paradise gas) by individuals under 18. The use of nitrous oxide in closed public places is also prohibited, except for medical purposes and specific cases under the Foodstuffs Act.

Section V. Supervision of Infectious Diseases

Section V deals with the supervision of infectious diseases. Border health control is implemented when necessary to protect the country from the spread of particularly dangerous infectious diseases. Prophylactic measures against infectious diseases include mandatory immunizations included in the national immunization calendar, purposed immunizations upon special indications, and recommended immunizations, with specific requirements determined by an ordinance of the Minister of Health. In extraordinary epidemic situations or significant reductions in immunization coverage, the Minister of Health can order additional anti-epidemic measures, which medical and health establishments, regardless of ownership, are obligated to implement. Individuals with infectious diseases, their contacts, and carriers are subject to registration, mandatory announcement, and accounting, with the specific diseases and procedures defined by an ordinance of the Minister of Health. National plans are developed to limit the spread of contagious diseases, defining specific actions, indicators, criteria, and timelines for introducing and revoking temporary anti-epidemic measures.

Section VI. Protection from Ionizing Radiation

Section VI addresses protection from the impact of ionizing radiation. Protection of individuals from ionizing radiation is implemented by observing radiation protection principles, including control of working and living environment factors, medical observation of exposed workers, and informing the public about radiation levels.

Activities involving sources of ionizing radiation require registration or permission from the Minister of Health or authorized bodies, with specific documentation requirements including information about the applicant, activities, measuring instruments, and qualified personnel for quality testing of medical radiological equipment.

Section VII. Protection from Asbestos

Section VII concerns protection against the harmful influence of asbestos and asbestos-containing materials. Activities involving asbestos require permission from the regional health inspection, following a submitted work plan detailing health and safety measures, employee lists, training certificates, and environmental protection measures.

Section VII. Resort resources and resorts

Section VII regulates the protection of health when using mineral waters, water intended for drinking purposes, sea bathing water, and mud treatment. The quality and control of these water resources are subject to health requirements, standards, and norms. The Minister of Health issues balneological assessments for mineral water deposits based on hydrogeological studies and water characteristics, upon proposal from basin directorates or municipal mayors.

Chapter III

Section I. Accessibility and quality of the medical care

Medical care in Bulgaria follows approved scientific and practical methods. It is regulated by medical standards and good practice rules. Every Bulgarian citizen has the right to accessible healthcare under the Health Insurance Act, ensuring timely, sufficient, and high-quality care with priority for vulnerable groups such as children and pregnant women.

Certain medical services are provided outside the mandatory health insurance system, including emergency aid, intensive treatment for uninsured individuals, maternity care, psychiatric care, organ transplants, and epidemic prevention. The state also funds specific treatments for uninsured persons, such as mental health support and methadone programs. Additionally, children and individuals with rare conditions receive continued treatment funding under specific regulations.

Bulgarian citizens may seek medical treatment abroad if no suitable options exist domestically, with state funding under defined conditions. Public health initiatives, immunizations, and epidemic control measures are fully covered by the state. Municipalities may also support healthcare for low-income and unemployed residents.

Foreigners with long-term or permanent residency, as well as refugees and individuals under temporary protection, receive medical care under the same conditions as Bulgarian citizens. Short-term visitors and transit passengers must cover their medical expenses unless covered by international agreements. European Union nationals receive healthcare at the same standards and pricing as Bulgarian citizens, ensuring equal access to medical services.

Section II. Rights and obligations of the patient

A patient is any individual who seeks or receives medical care. Registration as a patient occurs with informed consent, except in specific cases defined by law. Medical assistance is provided without discrimination based on age, gender, origin, language, race, political beliefs, education, culture, sexual orientation, social or material status, or the type and cause of an illness.

Patients are entitled to respect for their civil, political, economic, social, cultural, and religious rights. They should receive care within their community and have access to high-quality healthcare. They can seek multiple medical opinions regarding diagnosis, treatment, and prognosis. Their health data must be protected, and they have the right to clear and understandable information about their health status and treatment options. Preventive care and rehabilitation must be available, alongside reliable and safe diagnostic and therapeutic procedures. Efforts should be made to minimize pain and suffering during treatment. Patients also have the right to access up-to-date treatment methods and review their medical records.

During hospitalization, patients may be visited by their personal doctor and the specialist responsible for their admission. They can receive or refuse visits and have access to services from a psychotherapist, lawyer, or clergyman. Education and engagement in activities that meet social, religious, and cultural needs should be available. Patients must be informed about the costs of medical services, treatments, and medications.

The Public Council of Patient’s Rights operates under the Ministry of Health, comprising representatives from patient rights organizations, disability organizations, and healthcare professionals. This council monitors patient rights, analyzes related activities, prepares annual reports, and proposes amendments to relevant regulations. It also reviews and comments on draft laws concerning patient rights.

Organizations that protect patient rights must be non-profit entities working for the benefit of all patients, independent of specific illnesses. These organizations must be nationally representative and have regional structures. The government and relevant state authorities support these organizations, granting them access to legislative drafts and updates. They may report violations of patient rights and participate in advisory bodies and commissions.

Medical procedures require informed consent from the patient. For minors or individuals with limited legal capacity, a parent or guardian must also provide consent. However, parental consent is not required for certain preventive healthcare services for individuals under 16. In cases where a minor is placed outside their family by court order and parental consent cannot be obtained in time, a designated caregiver or social services representative provides consent.

Medical professionals must provide patients with detailed information regarding their diagnosis, the nature and goals of treatment, available alternatives, potential risks, side effects, and expected outcomes. This information must be presented in a timely and understandable manner, allowing patients to make informed decisions. For high-risk procedures such as surgeries or invasive treatments, consent must be given in writing. In emergencies where the patient cannot provide consent, life-saving treatment may proceed without it.

Patients can refuse medical care at any time. Such refusal must be documented in medical records. If a patient is unable to provide written confirmation of their refusal, a doctor and a witness must certify it. In cases where refusal poses a direct threat to life, the medical institution’s chief administrator may authorize life-saving treatment. Patients can withdraw their refusal at any time without legal repercussions for medical professionals.

Medical care may only be provided against a patient’s will in cases specifically established by law. Physicians must keep patients informed about their health status, treatment needs, risks, diagnostic and therapeutic alternatives, and the professionals involved in their care. Patients have the right to decline certain information unless their health condition poses a risk to others.

These rights and responsibilities ensure a balance between patient autonomy and the duty of medical professionals to provide appropriate care while maintaining ethical and legal standards in healthcare.

Section III. Medical care upon emergency status

The state of Bulgaria organizes and finances a system to provide medical care during emergencies. An emergency is defined as an acute or sudden change in a person’s condition that requires immediate medical attention. The primary goals of emergency medical care are to prevent death, severe or irreversible damage to vital organs and systems, and complications during childbirth that threaten the health and life of the mother or fetus.

In the event of an emergency, any person present at the scene is required to inform the nearest emergency medical center, another medical establishment, or the police. Medical establishments are obligated to provide the necessary medical care to patients in emergency situations, regardless of their citizenship, address, or health insurance status. If a medical establishment cannot provide the required care, the patient should be transferred to the nearest facility that can, provided the patient’s condition allows for safe transport. All relevant medical documents must accompany the patient during the transfer.

Transporting a patient is not permitted if it poses an unjustifiably high risk to their health and life.

Section IV. Medical expertise

Medical expertise in Bulgaria is organized and managed by the Minister of Health and the regional health inspections. It is implemented to establish temporary work inability, determine the type and degree of disability for children up to 16 years of age, and assess the degree of permanently reduced ability to work for individuals of active working age. This expertise also confirms professional diseases.

During temporary work inability examinations, an assessment is made to determine if the individual’s health condition permits them to appear before investigation or judicial authorities if necessary. The type and degree of disability and the degree of permanently reduced ability to work are determined in percentage relative to the abilities of a healthy person. For individuals eligible for a pension based on insured years of service and age, the type and degree of disability are determined for life, with re-certification possible upon request.

The principles and criteria for medical expertise, the process for establishing temporary work inability, and the determination of disability and reduced ability to work are outlined in an ordinance by the Council of Ministers. The term of the decision for the degree of permanently reduced work ability is determined based on the characteristics of the damage, its development dynamics, and recovery possibilities. In cases of definitive conditions with no possibility of recovery, the degree is determined for life.

The Regional Health Inspectorate notifies individuals of the need for re-certification before the expiry of their current term. If there is a delay in the medical examination, the validity of the last issued expert decision is extended until a new decision is issued. Information about delays and scheduled re-certification dates is communicated to relevant bodies and organizations.

The National Council in Medical Expertise, created at the Council of Ministers, develops national health policy statements related to medical expertise, coordinates activities between state bodies, analyzes the status of medical expertise, and proposes amendments to relevant regulations. The council includes representatives from various ministries and health organizations.

Medical expertise includes assessments of temporary work inability, the type and degree of disability, and permanently reduced ability to work. These assessments are conducted by doctors, medical consultative commissions (MCC), territorial expert medical commissions (TEMC), and the National Expert Medical Commission (NEMC). The expertise of the type and degree of disability for children up to 16 years of age involves specialists in children’s diseases.

The medical consultative commissions are established in medical establishments and include at least two permanent members. The territorial expert medical commissions are structural units of the medical establishments where they are opened. Doctors working in TEMC and NEMC must have recognized specialties and at least five years of medical practice.

The National Expert Medical Commission maintains an information database for all individuals who have undergone medical expertise to establish permanently reduced working capacity or disability. This database collects, processes, stores, and analyzes data for planning activities related to education, medical and social rehabilitation, employment, and assessing the health status of the population.

Control over medical expertise is implemented by the National Centre for Medical Expertise, the Minister of Health, the Minister of Labour and Social Policy, the National Health Insurance Fund (NHIF), the National Social Security Institute (NSSI), regional councils, and regional health inspections. Appeals and objections to decisions made by medical expertise bodies can be submitted within specific timeframes to higher bodies or administrative courts.

The decisions of medical expertise bodies are binding for all individuals, bodies, and organizations in the country once the appeal process is exhausted.

Section V. Medical ensuring at disasters, accidents and catastrophes

The management, organization, and resource allocation for health care during disasters, accidents, and catastrophes in Bulgaria are overseen by the Minister of Health, the chief state health inspector, the director of the National Centre for Radiobiology and Radiation Protection (NCRRP), the directors of regional health inspections, and various medical and health establishments. These bodies work in close coordination with central and local authorities, the Ministry of Interior, non-governmental organizations, and the Bulgarian Red Cross.

The Minister of Health is responsible for developing plans for medical ensuring during such events, which are then approved by the Council of Ministers. Based on these action plans, the responsible bodies create the necessary conditions for medical sorting, primary processing, treatment, rehabilitation, and medical expertise of the affected individuals. They also form and prepare management bodies and medical care teams, ensure the protection of stationary patients and medical staff from external factors, organize and implement anti-epidemic and hygienic activities, and maintain sanitary control in the affected areas. Additionally, they form stocks for resource allocation and organize continuous training for medical specialists and the population on providing medical care during disasters, accidents, and catastrophes.

The financial support for health care during these events is provided by the state budget. To implement medical ensuring at the regional level, a council for medical ensuring at disasters, accidents, and catastrophes is established under the director of the regional health inspection, who serves as the chairman. This council includes representatives from the regional health inspection, directors of hospital care establishments, the center for emergency medical care, and representatives from the regional administration and municipalities. The council approves action plans and training programs for medical teams working under disaster conditions.

Chapter IV

Section I. Health protection of children

The state, municipalities, corporate bodies, and individuals in Bulgaria are responsible for creating conditions that ensure a healthy living environment and normal physical and psychological development for children. To support families in raising children up to three years of age and to ensure their normal development, creches and children’s kitchens are established. Creches are organizationally detached structures where medical and other specialists care for, train, and educate children from three months to three years of age. Children’s kitchens are also organizationally detached structures where specialists prepare, preserve, and provide food for children up to three years of age. The requirements for the structure and activities of creches and children’s kitchens, as well as the norms for healthy feeding of children, are determined by an ordinance from the Minister of Health.

Creches and children’s kitchens can be created by municipalities, individuals, and corporate bodies. Municipal creches and children’s kitchens are established, transformed, and closed by the order of the mayor of the municipality, with the decision of the municipal council and the consent of the director of the corresponding regional health inspection. The maintenance of children in municipal creches and the activities of municipal children’s kitchens are supported by the respective municipal budget. Parents and guardians pay fees for receiving children’s food from municipal children’s kitchens, with the amounts determined by the municipal council in compliance with the Local Taxes and Fees Act. The state provides funds to parents to compensate for costs related to raising, upbringing, and educating children who were not accepted due to lack of places in municipal nurseries or nursery groups in municipal and state kindergartens.

Health offices in kindergartens and schools provide medical services, including first aid, support for children with chronic diseases, health promotion and prevention, and activities to prevent and limit the spread of contagious and parasitic diseases. They also participate in organizing recreation, tourism, and sports activities for children and students, and implement health education programs. These activities are carried out by medical doctors and other medical specialists with appropriate qualifications, under employment contracts with the mayor of the respective municipality or the person who established a private kindergarten or school. The financing of health offices in municipal and state schools and kindergartens is provided by municipal budgets, while private kindergartens and schools are financed by their owners. The regional health inspection controls the activities carried out by health offices.

Specialists from health offices are required to notify parents, guardians, or trustees and the general practice doctor of the child about any newly discovered disease or deviation in the child’s development. Students receive training on personal hygiene, healthy feeding, living environment, lifestyle, protection from infectious diseases, health risks associated with tobacco, alcohol, and narcotic substances, sexual conduct, protection from sexually transmitted diseases and AIDS, and first aid. The training of lecturers on these issues is organized by the Minister of Education and Science, in coordination with the Minister of Health. School boards of trustees organize measures to inform parents about children’s health problems.

Prophylactic medical and dental aid is provided to children and students in creches, kindergartens, schools, and social and integrated health and social services for residential care. This includes annual examinations or prophylactic medical and dental examinations, with the conditions and order for conducting these examinations determined by an ordinance from the Minister of Health. These activities are financed by the National Health Insurance Fund (NHIF).

Medical specialists are required to notify the Directorate “Social Support” of any child at risk of being left in a medical establishment, including cases where the mother’s identity documents are missing, or in cases of single mothers, mothers with many children, or mothers with serious or multiple diseases. They must also notify the Ministry of Interior and the Directorate “Social Support” of any child admitted to a medical establishment or health consulting room who is a victim of harassment.

Section II. Reproductive health

The state ensures the health protection of reproductive health through various measures. These include promoting and providing consultations for preserving reproductive health for children and individuals of reproductive age, ensuring access to specialized consultative assistance on reproductive health and family planning, and offering prophylactics and treatment for sterility. Additionally, specialized information, consultations, prophylactics, and treatment for sexually transmitted diseases and AIDS are provided, along with prophylactics, treatment, and dispensary observation for individuals with malignant diseases of the reproductive system. Everyone has the right to information and freedom of decision regarding their reproductive health.

For ensuring risk-free motherhood, every woman has the right to access health activities aimed at ensuring optimal health for both the woman and the fetus from the onset of pregnancy until the child is 42 days old. These health activities include promoting the health of the woman and the fetus, preventing the risk of abortion and premature birth, training in feeding and caring for the newborn, and active medical observation of the pregnancy on a dispensary basis by primary and specialized off-hospital care establishments. Prenatal diagnostics and prophylactics of genetic and other diseases are provided under conditions determined by an ordinance from the Minister of Health. Additionally, optimal living environments for women in childbed and newborns are ensured, along with dispensary observation and health care for the woman in childbed and the child. Pregnant women have free access to medical establishments for specialized off-hospital care and hospital care in cases threatening the pregnancy. They also have the right to choose the medical establishment for childbirth.

The conditions and order for implementing artificial abortion and the criteria for fetal viability are determined by an ordinance from the Minister of Health. This ordinance also outlines the obligations of medical specialists in cases of suspected abortion performed outside the conditions and order of the Act. Permanent divesting of the ability for reproduction is implemented under conditions and by order determined by an ordinance from the Minister of Health.

Section III. Assisted reproduction

Assisted reproduction is applied when the reproductive functions of a man or woman cannot be accomplished naturally. It is implemented after receiving written informed consent from the individuals wishing to create a generation. Medical investigations are conducted to guarantee the health of the offspring. Assisted reproduction follows a medical standard adopted by an ordinance from the Minister of Health.

Assisted reproduction includes activities such as using medical methods for fertilizing the ovum inside or outside the woman’s body, procuring, processing, labeling, transporting, and storing ova, spermatozoids, and zygotes, and placing an ovum in the body of the same or another woman. Donor ova can be used if the donor meets specific criteria, provides written consent certified by a notary, and is informed of the risks. The donor’s physical and psychological health must be confirmed by a commission of at least three physicians.

Medical establishments performing assisted reproduction must prepare annual reports on their activities and present them to the Executive Agency for Medical Supervision. It is prohibited to offer or receive material profit for donating ova or spermatozoids.

Assisted reproduction and the provision, use, and storage of human ova, spermatozoids, and zygotes are performed by medical establishments with the appropriate permissions and certifications. The Minister of Health can stop or withdraw permissions if the establishments fail to meet the medical standards. Medical establishments must maintain registers of all activities related to assisted reproduction and ensure the confidentiality of donor and recipient information.

The Executive Agency for Medical Supervision registers, analyzes, and controls assisted reproduction activities, ensuring quality and safety. It also maintains public and internal office registers, with data kept for 30 years. Medical establishments must notify the agency of any serious adverse reactions or incidents and have systems in place for immediate action.

Labeling and tracing of ova, spermatozoids, and zygotes are mandatory, and the use of assisted reproduction techniques for sex selection or genetic modification is prohibited, except for preventing inherited diseases. Reproductive cloning and genome modification for non-prophylactic or non-healing purposes are also prohibited. Discrimination based on a person’s genome is not allowed.

Section IV. Genetic health and genetic investigations

The preservation of genetic health in Bulgaria is ensured through various health activities. These activities include prophylactic and diagnostic investigations to identify and classify genetic diseases, a dispensary system for individuals at increased risk of genetic diseases, treatment of inherited diseases, congenital anomalies, and predispositions, establishing inherited characteristics and parentage, and preserving genetic information.

Prophylactic genetic investigations are conducted to determine the risk of genetic diseases in offspring, identify clinically healthy carriers of genetic deviations, and diagnose inherited and other diseases before and during pregnancy and after childbirth. These investigations are carried out under medical supervision and include proving genetic deviations in parents, establishing predispositions to genetic diseases, identifying genetic deviations caused by lifestyle or environmental factors, and diagnosing genetic diseases at their clinical manifestation.

National health programs conduct targeted investigations to establish the type and frequency of genetic deviations and determine the genetic fund. Genetic investigations and the collection of biological material for medical or scientific purposes require written informed consent from the individuals being investigated. For children, individuals with mental disorders, and those under guardianship, permission from the medical ethics commission at the respective medical establishment is also required. The results of genetic investigations and screenings cannot be used as a basis for discrimination, and data about an individual’s genome is considered personal data that cannot be shared with employers, health insurance organizations, or insurance companies.

Genetic investigations for medical or scientific purposes are conducted by accredited genetic laboratories at medical establishments for hospital and outpatient care, as well as independent laboratories. The Minister of Health designates a National Genetic Laboratory, which provides methodological guidance and control over genetic laboratories and maintains a national genetic register. The conditions and procedures for the National Genetic Laboratory and the register are determined by an ordinance from the Minister of Health.

Medical establishments conducting genetic investigations must report their activities and results to the National Genetic Laboratory monthly and maintain an official register of their investigations. These laboratories can also create DNA banks for scientific and medical purposes, which must be registered with the Ministry of Health within seven days.

A national register of patients with rare diseases is established to determine the type and frequency of rare diseases and to plan and provide preventive, diagnostic, and therapeutic activities related to these diseases. The terms, conditions, and procedures for registering rare diseases and the criteria for health care establishments wishing to participate in European reference networks are determined by an ordinance from the Minister of Health. This ordinance also outlines the establishment, designation, and functioning of rare diseases expert centers and reference networks.

Chapter V

Section I. Protection of the psychic health

The state, municipalities, and non-government organizations in Bulgaria organize activities to protect mental health through a comprehensive system of care and support. This includes ensuring accessible and high-quality medical care for persons with mental disorders, protecting mental health in risk groups (including children, students, elderly people, and institutionalized individuals), and implementing active prevention of mental disorders.

The system emphasizes specialized continuing education for mental health professionals, training programs for educators and medical practitioners, and scientific research aimed at strengthening mental health. Public awareness initiatives about mental health issues are also prioritized. Municipalities are responsible for providing psycho-social rehabilitation and support, including housing assistance for individuals with mental disorders.

Persons requiring special mental health care include those with serious mental disorders (such as psychosis or severe personality disorders), individuals with moderate to severe mental disabilities or dementia, and those with other mental function disorders that affect their ability to live independently. All individuals with mental disorders are entitled to treatment and care equal to that provided for other medical conditions.

Treatment of mental disorders follows key principles including minimal restriction of personal freedom, reduced institutional dependence, and priority for family and community-based care. The system promotes integration of psychiatric care with other medical services, emphasizes humanitarian approaches to treatment and social adaptation, and encourages self-help and mutual support networks.

Mental health services are provided through various medical establishments, including primary care facilities, specialized psychiatric care centers, mental health centers, and specialized hospital divisions. Treatment includes diagnostic investigations, medication, and psychotherapy, though surgical alterations to the central nervous system for psychological purposes are prohibited.

For patients who pose an immediate danger to themselves or others, temporary physical restriction measures may be applied under strict medical supervision for no longer than 6 hours. These measures must be documented and the patient kept under constant observation.

Labor therapy is incorporated into psycho-social rehabilitation programs, with safeguards against exploitation and forced labor. Healthcare offices staffed by medical professionals are established in residential care facilities with more than 20 persons with mental disorders, providing ongoing medical observation and basic healthcare services.

Emergency psychiatric care is provided through mental health centers and specialized medical facilities when a person’s behavior poses immediate danger. In cases requiring extended treatment, temporary accommodation can be arranged for up to 24 hours, with possible extension to 48 hours with judicial approval.

Section II. Compulsory accommodation and treatment

Compulsory accommodation and treatment may be required for individuals with serious mental disorders who, due to their condition, could pose a danger to themselves, their relatives, or society. This measure is implemented through a carefully regulated legal process that balances individual rights with public safety.

The decision for compulsory accommodation and treatment is made by the district court at the person’s address or, in emergency cases, by the court where the medical establishment is located. Treatment is provided in specialized psychiatric care facilities, mental health centers, or psychiatric divisions of multi-profile hospitals.

The legal process includes several key safeguards:

• The person has the right to make objections and present evidence within 7 days of receiving notice
• Court hearings must include a psychiatrist, legal defender, and prosecutor
• The person must be personally interviewed unless their health condition prevents it
• A judicial-psychiatric assessment must be conducted within strict timeframes
• Treatment during assessment requires either emergency status or informed consent

The court determines:

• The necessity of compulsory accommodation
• The designated medical facility
• Whether the person can provide informed consent
• Duration and form of treatment (ambulatory or stationary)
• If needed, appointment of a representative to provide informed consent
• Treatment orders are reviewed quarterly through judicial-psychiatric expertise. Compulsory treatment can be terminated early if conditions improve, upon request from the person, prosecutor, or medical establishment chief. The process ensures ongoing monitoring and the possibility of early release when appropriate.

Decisions can be appealed within 7 days, with appeals generally staying the execution unless otherwise ordered. The regional court must rule on appeals within 7 days, with these decisions being final.

Chapter VI

The application of unconventional methods for improving individual health in Bulgaria is regulated and controlled by the Minister of Health. These methods include the use of non-medicine products of organic and mineral origin, non-traditional physical methods, homeopathy, acupuncture, acupressure, and various diagnostic techniques such as iris, pulse, and auricular methods, as well as dietary practices and therapeutic fasting. Any unconventional methods not listed are prohibited.

The Minister of Health sets the requirements for individuals practicing these methods through an ordinance. Practitioners must be Bulgarian citizens or citizens of the European Union, the European Economic Area, or Switzerland. They must be mentally healthy, have no criminal record for unqualified crimes, and meet specific educational qualifications. For most unconventional methods, practitioners must have a master’s degree in medicine, dentistry, or pharmacy, or a bachelor’s degree in health care. Homeopathy practitioners must have a master’s degree in medicine or dentistry.

Practitioners of unconventional methods are required to act in good faith, avoid harming the health of those seeking their help, clearly explain the methods and expected results in accessible language, obtain explicit written consent, and avoid misleading individuals about the potential impact on their health.

Advertising of unconventional methods, especially in connection with prophylactics, diagnostics, treatment, and rehabilitation, is strictly prohibited. Practitioners must register with the regional health inspection where they practice, providing comprehensive details of the methods they will use. The registration process includes submitting an application with supporting documents, and the regional health inspection issues a certificate of registration if all requirements are met. The inspection can refuse registration if the methods violate normative requirements, and such refusals can be appealed.

The regional health inspection maintains a public register of practitioners, including details such as the practitioner’s name, methods practiced, and registration number. Practitioners must notify the inspection of any changes in their registration details within seven days. The registration can be deleted upon the practitioner’s request, death, or interdiction, or if incorrect data was provided, activities violate the registration, or adverse health effects result from the methods used. Deletion orders can be appealed, but the appeal does not halt the order’s execution.

Practitioners must keep a visit book, recording details of each visit, including the date, visitor’s name, complaints, and the unconventional activities performed. This book must be threaded, sealed, and registered by the regional health inspection and preserved for ten years after completion. Practitioners must present the book upon request by control bodies.

Chapter VII

Section I. Medical education

Medical education in Bulgaria is designed to ensure and guarantee the quality and extent of preparation for medical and non-medical specialists working within the national health care system. The education system is based on principles of high-quality teaching, a structured and continuous training process, and the right to choose a specialty.

Training for acquiring a master’s degree in fields such as medicine, dentistry, pharmacy, and public health is organized and conducted in accredited faculties of higher education institutions. Similarly, bachelor’s degrees in health care specialties, including nursing, midwifery, and medical assistance, are offered in accredited faculties, branches, and colleges. The training for a doctoral degree in scientific specialties related to health care is conducted in higher education institutions, the Bulgarian Academy of Sciences, national centers for public health issues, and other accredited scientific organizations.

Upon receiving their diplomas, doctors and dentists take the Hippocratic Oath, with the text approved by the Supreme Medical Council. For citizens of the European Union, the European Economic Area, and Switzerland, an equivalent oath is provided.

The Council of Ministers approves unified state requirements for acquiring higher education in regulated professions within the fields of medicine, dentistry, pharmacy, public health, and health care, based on proposals from the Minister of Health.

Postgraduate education is available for individuals with degrees in medicine, pharmacy, and health care, and includes training for acquiring specialties and continuing medical education. The Minister of Health annually determines the number of state-subsidized postgraduate training positions in line with the national health strategy’s objectives and priorities.

Theoretical training for postgraduate education is conducted by accredited higher education institutions and national centers for public health issues. Practical training is carried out in these institutions and in medical establishments approved by the Minister of Health. Specialties are acquired after completing study programs and passing practical and theoretical examinations before a state examination commission appointed by the Minister of Health.

The nomenclature of specialties, the conditions and procedures for training and acquiring specialties, and the financing of such training are determined by an ordinance from the Minister of Health, coordinated with the Ministers of Education and Science and Finance. The financing aligns with the national health strategy’s objectives and priorities.

Professional organizations for physicians, dentists, pharmacists, nurses, midwives, and associated medical specialists organize, coordinate, conduct, register, and monitor continuing medical education. This is done under conditions and procedures outlined in contracts with higher education institutions, the Bulgarian Red Cross, and the Military Medical Academy. Other associations and institutions also conduct continuing medical education under similar contractual arrangements.

Section II. Medical profesion

The medical profession in Bulgaria is regulated to ensure that only qualified individuals practice in the fields of medicine, dental medicine, pharmacy, and health care. To practice, individuals must hold a diploma certifying their higher education in the respective specialty and meet the professional qualifications as determined by state requirements.

Doctors and dentists practice under the conditions outlined in the Act on Professional Organizations of Physicians and Dental Practitioners, while nurses, midwives, associated medical specialists, dental technicians, and assistant pharmacists follow the regulations in the Act on the Professional Organizations of Nurses, Midwives, and Associated Medical Specialists, Dental Technicians, and Assistant-Pharmacists. Master-pharmacists also have specific conditions for practicing their profession.

The Ministry of Health maintains a public list of individuals who have graduated in these specialties. This list is accessible under the terms of the Access to Public Information Act. Professional organizations such as the Bulgarian Physicians’ Union, the Bulgarian Dentists’ Union, and the Bulgarian Pharmaceutics Union, along with other relevant professional bodies, provide information to the Ministry of Health about the registration and disciplinary actions of their members.

Citizens of the European Union, the European Economic Area, and Switzerland can practice in Bulgaria after their professional qualifications are recognized. They are also provided with opportunities to acquire necessary language skills and professional terminology in Bulgarian. Foreigners from other countries must demonstrate proficiency in Bulgarian and pass specific examinations to practice.

Medical professionals must adhere to high standards of professional competence, which are regulated by ordinances issued by the Minister of Health. Medical establishments are required to insure their staff against damages resulting from professional negligence. The conditions, procedures, deadlines, and minimum insurance amounts are determined by an ordinance from the Council of Ministers.

Medical professionals have the right to make decisions based on their qualifications, medical standards, and ethics. However, they cannot use commercial advertisements for their activities. They are also prohibited from practicing if they suffer from diseases that could endanger patients’ health and lives. The list of such diseases is determined by the Minister of Health, who can also remove a medical professional from the register if necessary. This decision can be appealed in court.

The Minister of Health can temporarily revoke a medical professional’s right to practice for repeated violations of medical standards or other serious infractions. These decisions are also subject to appeal, and the Ministry of Health must inform the relevant professional organizations and regional health inspections of any such orders.

Section III. is revoked

Section IV. Medical scientific studies of people. Medical science

The Ministry of Health in Bulgaria is responsible for organizing and controlling medical scientific studies involving human subjects. A medical scientific study is defined as any experiment conducted on people with the aim of increasing medical knowledge. Individuals participating in such studies are afforded all the rights of a patient, and their safety and the confidentiality of their personal data must be ensured. The well-being and interests of the study participant take precedence over the scientific and financial interests of the investigator at all stages of the study.

Medical scientific studies involving human subjects are prohibited under certain conditions, including when they contradict the law or medical ethics, lack sufficient evidence of safety or expected scientific benefits, do not comply with the scientific objective and study plan, or pose an increased risk to the participant’s health and life. Studies involving chemical substances, physical sources of radiation that could alter the human genome, or products of gene engineering that could transmit new characteristics to future generations are also prohibited.

Participation in medical scientific studies requires the written informed consent of the individual, who must be fully informed about the study’s essence, significance, scope, and potential risks by the study’s chief investigator. Consent can only be given by legally competent individuals who fully understand the nature of the study and can be withdrawn at any time. Medical scientific studies cannot be conducted on legally incompetent individuals. Pregnant and breastfeeding women and individuals deprived of their liberty cannot be subjects of medical scientific studies unless significant health benefits are expected.

The chief investigator of the medical scientific research, along with the research team, is jointly liable for any moral and economic damages caused to participants due to effects suffered during the study. The chief investigator is required to obtain insurance to cover this liability. The conditions, minimum insurance sum, premium, and procedures are determined by an ordinance from the Council of Ministers.

The chief investigator must be a doctor or dentist with a recognized medical specialty and is responsible for planning and conducting the studies. Medical scientific studies involving human subjects can only be conducted by qualified specialists with higher education in medicine, dentistry, pharmacy, biology, or biochemistry. Foreign individuals can conduct medical scientific studies only on the basis of a contract coordinated with the Minister of Health.

All medical scientific studies must receive a positive statement from a local ethics commission established at the medical or health establishment or scientific organization where the study is being conducted. The members of the commission are appointed by the head of the establishment or organization. Specialists involved in the preparation, organization, or conduct of the study cannot participate in the commission. The local ethics commission must provide its statement within 30 days of receiving the request from the chief investigator and exercises control over the conduct of the studies for which it has given a positive statement.

Upon completion of the medical scientific study, the chief investigator must inform the local ethics commission within 30 days. A medical scientific study can be terminated at any stage if the participant withdraws consent, a harmful effect on the participant’s health is detected, or upon the proposal of the chief investigator or the chairman of the local ethics commission due to proven omissions and breaches in the implementation process. In cases of termination due to harmful effects, the chief investigator must inform the local ethics commission within 15 days, and the Director of the regional health inspection will terminate the test.

The conditions and procedures for conducting medical scientific studies are determined by an ordinance from the Minister of Health, coordinated with the Minister of Education and Science. The Minister of Health determines scientific projects within the state scientific priorities in the field of medicine, based on proposals from higher education institutions, national centers for public health, scientific organizations, and other corporate bodies, and upon a statement from the Supreme Medical Council.

The Minister of Health announces competitions for contractors of scientific projects within the defined scientific priorities. The conditions and procedures for conducting the competition and the requirements for candidates are determined by an ordinance from the Minister of Health, coordinated with the Minister of Education and Science. Scientific projects are financed from state subsidies and other sources.

The body of a deceased person may be used for training and scientific research purposes in higher medical schools if the death has been established according to medical criteria and procedures. The use of the body requires the person’s written consent before death. In the absence of such consent, the body may be used with the written consent of a spouse, cohabitant, or relative. The higher medical schools must notify the relatives of the deceased after the training activity and cover the burial expenses.

Medical establishments act

The Medical Establishments Act in Bulgaria regulates the organization, management, and operation of medical establishments, ensuring the provision of high-quality healthcare services to the population. The act outlines the types of medical establishments, their functions, and the legal framework for their operation.

Part one

Chapter I.

Medical establishments are defined as organizationally separate structures where medical and non-medical specialists conduct activities related to diagnostics, treatment, rehabilitation, care for pregnant women, care for chronically ill patients, disease prevention, and health promotion. These establishments may also engage in education, postgraduate training of medical specialists, and scientific activities. Medical establishments can provide integrated medical-social services.

Medical and diagnostic activities may be carried out in the medical and dental faculties of universities during practical education of students and PhD students, postgraduate education of doctors and dentists, and scientific activities, in compliance with educational plans and programs.

Medical establishments, excluding those founded by the state, are established according to the Commerce Act or the Co-operatives Act, or as companies under the legislation of European Union Member States, subject to compliance with the requirements of this Act. Certain medical establishments are established by individual doctors and dentists or sole entrepreneurs registered by them. Medical establishments operate only upon obtaining a permit or registration. They cannot engage in commercial transactions except for activities related to medical services and patient care. State medical establishments must make payments for transactions within 60 days of receiving an invoice.

Medical establishments provide hospital and non-stationary care and are founded by the state, municipalities, corporate bodies, and individuals. All medical establishments have equal status regardless of ownership, and their medical activities are subject to control.

The state founds centers for emergency medical care, transfusion hematology, stationary psychiatric care, homes for medical and social care, centers for complex service of disabled children, and medical establishments within various ministries. Medical establishments for stationary psychiatric care can also be founded by other persons. Directors of state-founded medical establishments must submit information on medical activities, resources, and activity analysis to the Minister of Health.

Medical establishments and their specialists must adhere to medical standards for good medical practice and ensure the protection of patient rights. They must apply technologies and systems for gathering and exchanging information, as well as health-information standards. Medical establishments submit information about their medical activity and medical statistics. Medical establishments funded by the National Health Insurance Fund and/or the state budget must provide information on their expenses. State and municipal health care establishments for hospital care and complex oncology centers must also apply standards for financial activities. Control of medical establishments is carried out by the control authorities specified in this Act, the Health Act, and the Health Insurance Act.

Medical standards define the minimum obligatory requirements for structures carrying out activities in certain medical specialties or implementing individual medical activities to provide quality healthcare. Medical standards contain requirements for persons pursuing professional activity, requirements for carrying out activities in outpatient and hospital care structures, and quality criteria for the activities carried out. The requirements are determined by levels of competence, and medical standards are updated as necessary.

No medical establishment can refuse medical care to persons in life-threatening conditions, regardless of their place of living.

The Executive Agency “Medical Supervision,” under the Minister of Health, oversees medical establishments, medical activities, and the quality of medical care. It operates as a budget-supported legal entity managed by an Executive Director appointed under the Administration Act, with its structure and organization determined by government regulations.

The agency is responsible for registering, modifying, or revoking the registration of outpatient care institutions and hospices, as well as issuing and overseeing permits for medical establishments such as hospitals, mental health centers, oncology centers, and tissue banks. It also manages and monitors organ transplantation in accordance with the law, ensures adherence to medical practice standards, and verifies patient rights, medical standards, and financial compliance in healthcare facilities. Additionally, it oversees compliance with pharmaco-therapeutic manuals and enforces quality control in medical establishments.

As part of its mandate, the agency conducts planned and occasional inspections of medical establishments, ensuring compliance with legal and medical standards. It has the authority to investigate reports of violations and enforce disciplinary or administrative penalties. The agency collaborates with other regulatory bodies and submits an annual report to the Minister of Health.

Employees of the agency have the right to access necessary data, medical records, and service premises of medical establishments. They can issue mandatory prescriptions and monitor their implementation while maintaining confidentiality. The agency is funded through budget subsidies and revenue from fines and penalties, which are used to support its activities.

Part two

Chapter II.

This section of the Medical Establishments Act details the various types of medical establishments in Bulgaria, categorizing them based on the type of care they provide: non-stationary (outpatient) and hospital care.

Types of Medical Establishments

Article 8 outlines the medical establishments for non-stationary care:

1. Ambulatory for Primary Medical Care:
   • Individual Practice for Primary Medical Care
   • Group Practice for Primary Medical Care
2. Ambulatory for Specialized Medical Care:
   • Individual Practice for Specialized Medical Care
   • Group Practice for Specialized Medical Care
   • Medical Center and Medical Dental Center
   • Diagnostic and Consultative Center
3. Independent Medical Diagnostic and Medical Technical Laboratories
4. Dental Centers

Diagnostic-consultative centers may additionally open up to 5 beds for observation and treatment for 48 hours for clinical tests of medical products. If a longer stay is needed, the medical establishment must organize the patient’s hospitalization.

Article 9 describes the medical establishments for hospital care:

1. Hospital for Active Treatment
2. Hospital for Continuous Treatment
3. Rehabilitation Hospital
4. Hospital for Continuous Treatment and Rehabilitation

Hospitals can be multi-profiled or specialized. University hospitals are multi-profiled or specialized hospitals, determined by the Council of Ministers, where activities are carried out in clinical training of students and PhD students in medicine, dentistry, and pharmacy, clinical training for students in subjects of professional direction Health Care, and postgraduate training of doctors, dentists, pharmacists, and specialists in health care.

It is permissible for another medical establishment for hospital care to perform its activity on the territory of a state or municipal medical establishment for hospital care, provided that the clinics, departments, and laboratories in the two medical establishments for hospital care carry out different medical activities.

Article 10 lists other medical establishments:

1. Center for Emergency Medical Care
2. Center for Transfusion Haematology
3. Mental Health Center
4. Skin and Venereal Disease Center
5. Complex Oncology Center
6. Home for Medical and Social Care
7. Center for Complex Service of Disabled Children and Chronic Diseases
8. Hospice
9. Dialysis Center
10. Tissue Bank

Chapter III.

This chapter focuses on medical establishments that provide non-stationary (outpatient) care, detailing their functions, organization, and operational requirements.

Article 11 outlines the activities carried out in ambulatories for primary or specialized non-stationary care, where doctors or dental practitioners:

1. Carry out:
   • Diagnostics, treatment, rehabilitation, and care of patients
   • Consultations
   • Prophylactics
   • Dispensarization
2. Prescribe:
   • Laboratory and other types of tests
   • Medical activities and manipulations under their supervision and responsibility
   • The volume and type of home care and aid to patients
   • Medical supplies, dressing materials, and medical instruments
3. Carry out expertise of temporary incapacity
4. Provide care and render medical aid for pregnancy and maternity
5. Observe, control, and care for the physical and psychological development of persons under 18 years of age
6. Carry out activities on health promotion and prophylactics, including prophylactic examinations and immunizations
7. Issue documents related to their activity
8. Direct patients for consultative and hospital care

Clinical testing of medicinal products may be carried out at a medical center, a medical-dental center, a dental center, and in individual and group practices for primary and specialized medical care. Doctors and dental practitioners in these ambulatories must treat patients in their homes when the patient’s condition requires it and hospitalize patients when treatment cannot be achieved in ambulatory conditions or at home. Dental practitioners with appropriate qualifications may carry out image diagnostics of patients’ teeth and jaws.

Article 12 states that the type of ambulatory is determined by the nature of the activity, the number and qualification of the doctors or dental practitioners, and the way of organization.

Article 13 specifies that individual practice for primary medical care is organized and carried out by a doctor with a recognized specialty in general medicine or by a doctor in dental medicine, who must be registered. Individual practice for specialized medical care is organized and carried out by a doctor with a recognized specialty other than general medicine or by a doctor in dental medicine with an acknowledged specialty, who must also be registered. These individuals can hire other persons according to the needs and volume of the medical activity. They must appoint deputies in cases of their absence, informing the regional health inspection and the regional health assurance fund. The deputy must have the respective legal capacity and be entered in the respective register. The conditions and order of substitution for absences over 10 days are settled by the contract for providing medical care with the regional health assurance fund.

Article 14 states that group practice for primary medical care is carried out by a trade company or cooperative founded by doctors with recognized specialties in general medicine or by doctors in dental medicine, which must be registered. Group practice for specialized medical care is carried out by a trade company or cooperative founded by doctors with the same recognized specialty other than general medicine or by doctors in dental medicine with the same acknowledged specialty, which must be registered. These individuals can also hire other persons according to the needs and volume of the medical activity.

Article 14a states that doctors admitted to training for specialization in general medicine are also entitled to organize and carry out an individual or group practice of primary medical care after registration, for a period not longer than the time limit for training for the specialty.

Article 15 allows individuals to conclude contracts for carrying out medical activity with doctor’s assistants and nurses (midwives) working in another populated area.

Article 16 defines a medical center or medical and dental center as a medical establishment providing non-stationary care, with at least three doctors and/or three dental practitioners with different acknowledged specialties. A dental center is a medical establishment in which at least three physicians in dental medicine of different acknowledged specialties provide primary and specialized non-stationary dental care. Medical centers, dental centers, and medical and dental centers are managed by a doctor or dental practitioner with an acknowledged specialty. The structure, activity, and internal order of the center are settled by regulations approved by the manager.

Article 17 defines a diagnostic and consultative center as a medical institution carrying out specialized outpatient care with at least 10 physicians with various acknowledged specialties. The center must be supplied with the necessary medical equipment and have at least one medical diagnostic laboratory and a unit for image diagnostics. The diagnostic and consultative center is managed by a doctor with an acknowledged specialty and qualification in health management or a master of economics and management with an acquired educational or scientific degree, subject, or passed education for raising qualification in the area of health management. The structure, activity, and internal order of the center are settled by regulations approved by the manager. Clinical trials of medicinal products may be carried out at the diagnostic and consultative center.

Article 17a allows medical, medical dental, and diagnostic consulting centers to establish units in which medical assistants, medical nurses, and midwives can provide obstetrical services and health care. The types of activities carried out in these units are determined in compliance with the Ordinance under Art. 7, par. 1 of the Act on the Professional Organizations of Nurses, Midwives and Associated Medical Specialists, Dental Technicians and Assistant-Pharmacists. The units are managed by persons having an educational and qualification degree of “Bachelor” in the subjects medical assistant, nurse, or “obstetrics” and a professional experience of not less than two years. The procedure of implementation of activities in the units is ruled in the Regulations for organization, operation, and in-order of the respective medical establishment.

Article 18 defines an independent medical and diagnostic laboratory as a medical establishment in which doctors, with the assistance of other specialists, carry out specialized medical tests in one or more medical subjects prescribed by another doctor or dental practitioner. Working in it must be at least one doctor with an acknowledged specialty in each of the directions of the laboratory activity. An independent medical technical laboratory is a medical establishment in which specialists with the respective education carry out specific technical activities and produce specialized medical products prescribed by a doctor or dental practitioner. The independent medical diagnostic laboratory is managed by a doctor with an acknowledged specialty in one of the directions of the laboratory activity. The independent medical technical laboratory is managed by a doctor, dental practitioner, or specialist on the profile of the laboratory. The requirements for carrying out the activities of the laboratories are determined by the relevant medical standards. The structure, activity, and internal rules of the laboratories are provided by Rules confirmed by the head of the laboratory.

Chapter IV.

This chapter details the functions, requirements, and classifications of medical establishments that provide inpatient healthcare services in Bulgaria.

Medical establishments for hospital care are defined as facilities where doctors, assisted by other specialists and auxiliary personnel, carry out specialized healthcare activities. These activities include diagnosing and treating diseases that cannot be managed in outpatient settings, providing natal care, offering rehabilitation services, and conducting diagnostics and consultations requested by other medical professionals or establishments. They may also perform transplantation of organs, tissues and cells; collect, store, and supply blood and blood components; conduct clinical tests of medicinal products and medical devices; and engage in educational and scientific activities.

For a medical establishment to provide stationary care, it must operate in compliance with established medical standards and good practice rules, employ medical specialists under primary employment contracts, have technically sound medical equipment and facilities on its premises, and adhere to approved financial standards where applicable. These establishments must ensure uninterrupted 24-hour medical service in all medical specialties authorized in their operating permission, including emergency medical care.

In certain medical establishments for hospital care, consultative offices, medical-diagnostic and medical technical laboratories, and wards without beds may also provide outpatient care activities.

The legislation defines several types of hospitals based on their functions and the care they provide:

1. Hospitals for active treatment admit patients with acute diseases, traumas, aggravated chronic conditions, conditions requiring operative treatment in hospital conditions, and provide natal care. These facilities may also incorporate structures for continuous treatment and rehabilitation. Additionally, they can offer complex medical care for individuals with specific illnesses, disabled children, and those with chronic diseases. These complex care services may be organized functionally through the hospital’s structural units, especially for individuals with psychotic, skin, venereal, and oncological conditions.
2. Hospitals for continuous treatment serve individuals requiring long-term health recovery and those with chronic diseases needing care and maintenance of satisfactory physical and psychological condition.
3. Rehabilitation hospitals admit persons needing physical therapy, motor and psychological rehabilitation, and various therapeutic approaches including balneological, climatological, and thalassotherapy.
4. Hospitals for continuous treatment and rehabilitation combine the activities of both continuous treatment and rehabilitation facilities.

The law further categorizes hospitals as either multi-profile or specialized. A multi-profile hospital contains departments and clinics for at least two medical specialties. A specialized hospital focuses on a single medical or dental specialty but may include structures for surgery, therapeutic procedures, clinical diagnostics, and anesthesiology and intensive care as needed to support its specialized function.

The organization of complex care services in hospitals must be detailed in the facility’s rules of procedure, activity, and internal order. Any expansion of services to include continuous treatment, rehabilitation, or complex care requires obtaining official permission from the appropriate authorities.

This comprehensive framework ensures that hospital care in Bulgaria is delivered according to standardized approaches, with appropriate medical expertise and equipment, and with clear guidelines for different types of care based on patient needs.

Chapter V.

This chapter describes various specialized medical establishments that provide specific types of healthcare services in Bulgaria.

The Centre for Emergency Medical Care is a medical establishment where healthcare professionals render emergency medical assistance to sick and injured persons at various locations, including homes, accident sites, and during transportation to hospitals.

The Centre for Transfusion Haematology is dedicated to blood-related services, including taking blood and blood components, diagnosing, processing, storing, and providing blood and blood components, producing blood biological preparations, and carrying out transfusion supervision. These centers operate according to the requirements of both the Medical Establishments Act and the Blood, Blood Donation, and Blood Transfusion Act.

The Mental Health Centre focuses on psychiatric services, providing emergency psychiatric aid, diagnosis and treatment of persons with mental disorders, periodic monitoring and consultation of patients, psychotherapy and psycho-social rehabilitation, psychiatric and psychological expert activity, and maintaining a regional information system for individuals with mental disorders. These centers also conduct activities related to mental health promotion, prevention, public information, and research. The mental health center is structured to include reception-diagnostic units, emergency and mobile psychiatric aid units, active treatment facilities for persons with severe mental disorders, and rehabilitation and resocialization units. These centers may also provide social services as defined in the Social Support Act.

The Skin and Venereal Disease Centre specializes in diagnosing, treating, and rehabilitating individuals with dermatological conditions and sexually transmitted diseases. These centers monitor epidemiological indices for sexually transmissible infections, provide expert activities in sexual health, and conduct public education and research activities. The center includes specialized diagnosis and consultation offices, wards, and assistance units, with the possibility of having up to 10 accommodation places for diagnosis and treatment.

The Complex Oncology Centre is dedicated to cancer-related healthcare, including active search, diagnosis, and treatment of persons with oncological diseases, monitoring and registration of cancer patients, maintaining an information database for the National Cancer Registry, and conducting prevention and public information activities related to cancer. The center has a diagnostic and consultation block, a stationary block with departments for medical oncology, radiation treatment, and oncological surgery, a unit for registration and prevention of oncological diseases, and a pharmacy. These centers may also provide social services and palliative care.

The Home for Medical and Social Care provides continuous medical observation and specific care for persons with chronic diseases and those requiring specific home care due to chronic disabling conditions and medical-social problems. These establishments may also provide social services as outlined in the Social Support Act.

The Centre for Complex Service of Disabled Children and Children with Chronic Diseases supports families with disabled children and those with chronic diseases by providing early diagnostics, treatment, and rehabilitation. These centers offer continuous treatment and rehabilitation services, specialized home visits, and palliative care. They work in coordination with other medical establishments to ensure comprehensive care and may provide social services under the Social Support Act.

The Hospice provides palliative care for terminally ill patients, with the treatment activity managed by a medical specialist. Hospices qualifying as medical establishments may also provide social services.

The Dialysis Centre specializes in treatment, rehabilitation, and observation of patients with chronic kidney insufficiency. These centers are managed by doctors with recognized medical specialties and at least two years of practice in hemodialysis. Clinical trials of medicinal products can be conducted at dialysis centers under the Medicinal Products in Human Medicine Act.

The Tissue Bank is a medical establishment where physicians take, study, label, treat, transport, store, and process organs, tissues, and cells for medical purposes. Tissue banks may take tissues and cells for implantation or processing, and organs only for processing.

Each of these specialized medical establishments is required to have regulations governing their structure, activity, and internal operations, approved by the head of the establishment. Their medical activities are carried out in structural units that have defined levels of competence in compliance with established medical standards.

Part three

Chapter VI.

This chapter outlines the framework for healthcare planning in Bulgaria through a system of health maps at regional and national levels, ensuring that medical services are distributed according to population needs across the country.

The National Health Map serves as the foundation for implementing Bulgaria’s healthcare policy by defining and planning the population’s needs for accessible outpatient and hospital medical care on a territorial basis. It is created by consolidating regional health maps, which are developed by specially appointed commissions in each region.

Each regional commission is chaired by the regional governor and includes representatives from various healthcare stakeholders: regional health inspection, regional health insurance bank, professional medical organizations (Bulgarian Physicians’ Union, Bulgarian Dentists’ Union, Bulgarian Association of Healthcare Professionals), patient rights organizations, and municipal representatives. This diverse composition ensures that multiple perspectives inform healthcare planning.

The regional health maps are developed using standardized methods approved by the Minister of Health. The commissions must consider healthcare accessibility for populations living in remote areas and conduct comprehensive analyses of healthcare needs and existing resources. These analyses include evaluations of emergency services, primary care, specialized non-stationary care, and hospital care, as well as assessments of whether medical establishments meet required standards.

Each regional health map contains detailed information about the region’s demographic structure, disease patterns across different population groups, hospitalization rates, the number and distribution of existing medical establishments, and their activities. The maps also specify the necessary minimum number of physicians, dental practitioners, and healthcare specialists by specialty, the number of hospital beds, the types of medical activities performed, and information about high-tech diagnostic and treatment methods available in the region.

These regional maps must include proposals for distributing hospital beds and medical activities according to population needs, as well as recommendations regarding healthcare professional requirements. The commissions may also suggest restructuring medical establishments or optimizing healthcare delivery, including the creation of specialized services like palliative care.

The National Health Map is compiled by a national commission appointed by and chaired by the Minister of Health. This commission includes the head of the National Health Insurance Fund, directors of key health agencies, representatives from professional medical associations, municipalities, and patient organizations. The national map synthesizes the regional maps and establishes the broader framework for healthcare delivery across the country.

The National Health Map identifies regional needs for healthcare professionals in various specialties, determines the appropriate number of hospital beds and medical activities by type and level of competence, maps existing medical establishments, provides analyses of regional conditions, and specifies medical activities to be planned at the regional level. It also includes maps of high-technology diagnostic and treatment methods and their associated equipment, as well as a map of first aid services showing the number and location of first aid centers.

Importantly, the National Health Map serves as the basis for financial decisions. Medical establishments for hospital care can receive funding from the state budget or the National Health Insurance Fund only for activities that comply with the requirements outlined in the map and related regulations. This creates a direct link between healthcare planning and resource allocation.

The National Health Map is approved by the Council of Ministers based on a proposal from the Minister of Health. It undergoes complete updating every three years, with partial updates made as necessary according to defined methodologies. The map is mandatory for planning medical activities in medical establishments, with certain exceptions for dental medicine facilities.

In regions where the number of hospital beds exceeds the needs defined in the National Health Map, the directors of Regional Health Insurance Funds sign contracts with selected medical establishments based on criteria established by the Council of Ministers. This mechanism helps control healthcare capacity and ensures appropriate distribution of resources.

Through this comprehensive system of health mapping, Bulgaria aims to create a healthcare network that responds to population needs while maintaining efficiency in resource allocation and service delivery.

Chapter VII.

Section I. Founding medical establishments

Medical establishments related to emergency care, transfusion services, psychiatric care, specialized children’s services, and those affiliated with government ministries are founded through a structured governmental process. The Council of Ministers establishes these facilities based on proposals from the Minister of Health, with coordination from relevant ministries when appropriate. These establishments operate as corporate entities with budget support for their specific functions.

The organizational structure and activities of these state-founded establishments are regulated through specific regulations issued by different authorities: the Minister of Health oversees emergency medical centers, transfusion centers, psychiatric care establishments, and facilities for children; the Council of Ministers regulates establishments affiliated with specific ministries; and the Minister of Defense, in coordination with the Minister of Health, oversees military medical institutions.

Before regulations are issued for these establishments, they must undergo verification by regional health inspections to ensure compliance with medical standards and health requirements. Special provisions apply to establishments planning to conduct organ transplantation activities or perform other specialized procedures, requiring additional verification and certification by the Executive Agency “Medical Supervision.”

Medical establishments for non-stationary care and hospices are formed as trade companies or cooperatives, following specific registration procedures. When necessary, the state and municipalities may establish such facilities as limited liability or joint-stock companies. Individual and group practices for primary and specialized medical care have specific registration requirements, with individual practices established by physicians or dental practitioners registered directly.

Tissue banks must be established as limited liability or joint-stock companies and can only operate after receiving a permit. Their activities are strictly limited to those specified in the law.

Medical establishments for hospital care, mental health centers, dermatology centers, complex oncology centers, and dialysis centers can be established by various entities, including state, municipal, legal, and natural persons. These establishments must operate only after obtaining a permit as outlined in the law. Their activities are strictly limited to hospital care and related specific functions. When the state or municipalities establish such facilities, they must be formed as limited liability or joint-stock companies. State-founded establishments require an act of the Council of Ministers, while municipally-founded establishments need municipal council permission and consent from the Minister of Health.

A particularly rigorous process applies to the formation of new hospital care establishments, requiring Council of Ministers approval based on a comprehensive assessment conducted by the Executive Agency “Medical Supervision.” This assessment considers population healthcare needs according to the National Health Insurance Card and evaluates detailed project information, business plans, funding sources, and professional opinions. The Council’s approval decision specifies the type of establishment, its structure, bed capacity, medical activities, and implementation timeframe.

Similarly stringent procedures govern the introduction of new medical activities in existing hospital establishments, requiring ministerial approval based on comprehensive assessments of healthcare needs and operational capabilities. The Minister of Health’s authorization order specifies the types of new activities, implementing structures, bed capacity, competence levels, and project timeline.

For state and municipal medical establishments, special provisions exempt them from certain Commerce Act requirements regarding non-cash capital contributions. Instead, all long-term assets are valued at their balance sheet value when determining the company’s capital.

This structured approach to founding medical establishments ensures that new healthcare facilities and services align with population needs, meet quality standards, operate within appropriate legal frameworks, and utilize resources efficiently within Bulgaria’s healthcare system.

Section II: Registration of Medical Establishments

This section details the registration process for medical establishments for non-stationary (outpatient) care and hospices in Bulgaria, as well as the registration of medical activities in university settings.

Medical establishments requiring registration include outpatient care facilities, hospices, and certain medical activities in university settings where up to 10 beds for observation and treatment for up to 48 hours may be provided. If longer stays become necessary in university settings, the medical or dental faculty must arrange hospitalization for the patient. The Minister of Health determines the basic requirements for the structure, activity, and internal operations of these establishments through an ordinance.

The registration process is managed by the Executive Director of the Executive Agency “Medical Supervision” and begins with an application that includes the unified identification code of the company or cooperative from the Commercial Register. For facilities registering in Bulgaria, applicants must submit documentation including rules for structure and operations, names of partners or shareholders, diplomas and specialty certifications for managing personnel, permits for any equipment using ionizing radiation, and proof of paid state fees. The application is initially submitted to the Regional Health Inspection.

For companies registered in European Union member states or states party to the European Economic Area Agreement, a document verifying current registration under their national legislation is required. The Executive Agency “Medical Supervision” checks criminal backgrounds of management personnel, with non-Bulgarian citizens required to submit criminal record documentation.

Within 10 days of receiving an application, the Regional Health Inspectorate conducts a compliance check to ensure the establishment meets health requirements and approved medical standards. If deficiencies are found, the inspectorate prescribes corrections and sets a time limit not exceeding three months. Simultaneously, the inspectorate requests certificates from professional organizations—the Bulgarian Medical Association, Bulgarian Dental Association, or Bulgarian Association of Healthcare Professionals—verifying the registration of medical professionals who will work at the establishment.

For university medical activities, the registration application is submitted by the university’s Rector and must include details about the higher education institution, diplomas and specialty certificates of department heads and teaching staff, permits for equipment using ionizing radiation, institutional accreditation, program accreditation, information on available beds, and proof of paid state fees.

Special provisions apply for establishments planning to perform organ, tissue, and cell transplantation or assisted reproduction. In these cases, the Executive Agency “Medical Supervision” conducts additional checks to verify compliance with established medical standards in these specialized fields. If discrepancies are found, corrections must be made within three months.

The Executive Agency “Medical Supervision” maintains a comprehensive public register of medical establishments that includes registration certificates, establishment details, management information, permitted activities, and any subsequent changes or terminations. A separate section records applications in process. Fees for registration certificates and register use are determined by the Council of Ministers.

Registered establishments must inform the Executive Agency “Medical Supervision” about any changes within seven days of their occurrence. The Executive Director may issue a motivated refusal of registration for several reasons, including document omissions, criminal convictions of management personnel, failure to meet health requirements, non-compliance with medical standards, or lack of proper professional registration of medical staff. Such refusals can be appealed through the administrative court system.

Registration can be canceled under various circumstances: if a founding doctor or dentist is deleted from their professional register, for violations of registration terms or approved medical standards, for extended suspension of activity, upon request of the establishment, or upon termination of the corporate body or death of the registered person. For university medical activities, registration can be canceled upon request of the university rector, closure of the relevant faculty, expiration of program accreditation, or activities violating registration terms.

Cancellation orders can be appealed through the administrative court system, though filing an appeal does not suspend the order’s execution. This ensures that regulatory actions to protect public health take immediate effect, even during the appeal process.

This detailed registration framework creates a standardized, transparent system for authorizing and monitoring outpatient care facilities, ensuring they meet professional, technical, and safety standards before beginning operations and throughout their existence.

Section III: Permit for Medical Activities

This section outlines the comprehensive framework governing the authorization process for medical establishments providing hospital care and specialized medical services in Bulgaria.

Medical establishments requiring operating permits include hospitals, mental health centers, dermatology centers, complex oncology centers, homes for medical-social care, dialysis centers, and tissue banks. The Minister of Health issues these permits based on recommendations from the Executive Director of the Executive Agency “Medical Supervision.”

The basic structural, operational, and organizational requirements for hospital care facilities and medical-social care homes are established through ministerial ordinances. For hospital care establishments, permits are granted only after approval by the Council of Ministers through the formal assessment process described in Article 37a.

The permit application process begins with the medical establishment submitting documentation to the Regional Health Inspection, including: - Company registration information or documentation of current registration for entities from EU/EEA countries - Organizational and operational rules - Higher education credentials for management personnel, including health management qualifications - Identity information for members of management and control bodies - Permits for any equipment using ionizing radiation - Standard operating procedures for tissue banks - Proof of paid state fees

The Regional Health Inspection conducts an initial review within 20 days, verifying compliance with legal requirements, ministerial ordinances, and approved medical standards. If deficiencies are identified, the inspection gives the establishment up to three months to address them. Simultaneously, the inspection requests professional registration verification from the Bulgarian Medical Association or Bulgarian Dental Association for physicians and dentists in management positions.

For establishments planning to perform organ transplantation or assisted reproduction, the Executive Agency “Medical Supervision” conducts specialized verification of compliance with established medical standards in these fields. Any discrepancies must be corrected within three months.

Within 75 days of the initial application filing, the Minister of Health issues an operating permit or provides a reasoned refusal. The permit specifies crucial details including the establishment’s full name, identification codes, authorized medical activities and specialties, competence levels of different structural units, and physical address.

The Minister may refuse a permit for several reasons: if the Council of Ministers denied establishment approval; if document deficiencies weren’t corrected; if management personnel have criminal convictions; if the establishment fails to meet health requirements or medical standards; or if physicians and dentists aren’t properly registered with their professional organizations. Such refusals can be appealed through the administrative court system.

The Ministry of Health maintains a public register of all permitted medical establishments, recording permit details, establishment information, competence levels, management personnel, authorized activities, and any subsequent changes or revocations. Permitted establishments must notify authorities of any changes in their circumstances within seven days. Substantial changes to the permit, particularly adding new medical activities, require the same rigorous approval process as initial permits.

The Minister of Health may revoke permits under specific circumstances: if the permit was issued based on false information; if the establishment performs unauthorized activities; if it violates health legislation; if it repeatedly violates medical standards; if it fails to begin operations or suspends them for six months; or upon the establishment’s request to terminate activities. Revocation orders specify when medical activities must cease and can be appealed through the administrative court system, though appeals don’t suspend the order’s execution.

For serious but isolated violations, the Minister may partially revoke a permit, restricting only the specific medical specialties involved rather than stopping all operations. This balanced approach allows continued operation of compliant departments while addressing problematic areas.

This comprehensive permitting system ensures that hospital care and specialized medical services in Bulgaria are provided only by establishments that meet rigorous standards of professional qualification, technical capability, and organizational structure. The process balances the need for thorough oversight with reasonable timeframes and clear appeal mechanisms, supporting the overall goal of maintaining high-quality healthcare services throughout the country.

Section IV: Closing Down Medical Establishments

This section describes the process and requirements for closing medical establishments in Bulgaria, ensuring orderly transition and protection of patient interests during these procedures.

For state medical establishments under Article 5, paragraph 1, closure is initiated through an act of the Council of Ministers based on a proposal from the Minister of Health, coordinated with the relevant ministry. This closure act specifies which minister will appoint the liquidation commission members, establishes the timeframe and tasks for the commission, and allocates necessary resources for completing the liquidation process.

The liquidation commission consists of at least five members, including representatives from the administrative body or municipality where the establishment was registered, the Ministry of Health, and qualified legal and economic professionals. Commission members enter into contracts with the supervising minister, who ultimately accepts the commission’s concluding report.

The specific conditions and procedures for liquidating state medical establishments are determined by a Council of Ministers ordinance, providing standardized guidance for these complex processes.

For medical establishments organized as trade companies or cooperatives, termination and liquidation follow the Commerce Act procedures, with foreign companies following their national legislation. However, in bankruptcy proceedings for medical establishments, certain provisions of the Commerce Act are modified—cash distraint as security is not permitted, and some standard bankruptcy provisions do not apply. Municipal medical establishments can only be terminated with the consent of the Minister of Health.

When terminating a medical establishment, the decision must designate one or more liquidators and specify their remuneration. A liquidator must possess specific qualifications, including higher education with a master’s degree in medicine, dental medicine, economics, or law. They cannot have been deprived of the right to hold material accountancy positions or have been involved in companies terminated due to insolvency with unsatisfied creditors.

The liquidators have specific public notification responsibilities—they must announce the termination of medical activities in at least one central and one local daily newspaper within seven days of their appointment and post notices in public locations and at the medical establishment. They must also inform the district health insurance fund and the territorial directorate of the National Revenue Agency about the liquidation within fourteen days of appointment.

During the liquidation process, liquidators must create conditions for completing any ongoing medical activities while prioritizing patient interests. Particularly important is their obligation to ensure patients can access their medical records and treatment documentation from the establishment being liquidated, protecting continuity of care during this transitional period.

This structured approach to closing medical establishments balances administrative and financial considerations with the paramount need to protect patient welfare, ensuring that even during institutional closure, healthcare needs remain a priority.

Chapter VIII.

Section I. Structure of Medical Establishments for Hospital Care

Medical establishments for hospital care in Bulgaria are structured as comprehensive healthcare facilities comprised of several key components. These include clinics and/or departments with beds, medical diagnostic and technical laboratories, departments without beds, hospital pharmacies, consulting rooms, and units for administrative, economic, and service activities. The level of competence for clinics, departments, and diagnostic laboratories is determined according to established medical standards, with specific criteria and procedures defined by ministerial ordinance.

A clinic represents a specialized hospital unit focused on a specific medical or dental specialty. It must be headed by an individual with academic rank who is either a physician or dental practitioner. Clinics perform diagnostic and treatment activities while also providing education for students, specialist training, and/or continuing professional qualification. When specified in the medical establishment’s structural regulations, clinics may be further subdivided into departments.

A department functions as a hospital unit dedicated to a particular medical or dental specialty, led by a physician or dental practitioner with recognized specialization in the relevant field. These units focus primarily on diagnostic and treatment activities but may also participate in post-graduate specialist education or continuing professional qualification.

Section II. Management and control of the medical establishments

Management and oversight of these medical institutions depend on their organizational structure. Ownership arrangements define who appoints and removes those in charge and the nature of their contracts. Those serving as manager, executive director, or director must hold a master’s credential in medicine, dental medicine, or economics and management, combined with specialized qualifications in the healthcare domain. They are selected through a competitive procedure for a set term, with the possibility of renewal, yet their contracts may end earlier for reasons such as institutional reorganization or failure to meet agreed-upon performance criteria.

The person in charge is responsible for the financial stability of the institution and represents it externally. That role also includes appointing and releasing employees, introducing structural adjustments, and submitting information on operations to relevant parties. Certain institutions require a single management tier composed of three members. This leadership cannot simultaneously head clinical departments within the same institution. A chief nurse (or similar professional) ensures quality patient care, proper hygiene standards, and training of other healthcare workers.

Clinical operations are managed by qualified specialists who lead clinics, departments, or laboratories relevant to their field. They employ and release personnel in their area, manage budgets and workflows, and coordinate collaboration with chairs at higher education institutions. Their agreements usually have fixed durations and involve accountability for results. Each institution features bodies devoted to consultation, oversight, and quality control. These range from advisory councils that review activities and propose improvements to commissions that assess the effectiveness of treatment methods, investigate challenging cases, and promote adherence to best practices. Infection prevention teams maintain hospital hygiene and monitor standards for disinfection, while a caregiving council assists the chief nurse in planning and coordinating nursing and related services.

This integrated approach ensures transparent management, efficient use of resources, and adherence to standards of care. All individuals with managerial or supervisory duties are expected to fulfill legal, professional, and ethical responsibilities aimed at preserving financial stability and delivering quality healthcare.

Section III. Personnel in the medical establishments

Personnel in medical establishments in Bulgaria include a diverse range of professionals, such as doctors, dental practitioners, pharmacists, and other specialists with advanced degrees who participate in diagnostic and treatment processes. University hospitals also employ lecturers who are involved in both clinical duties and teaching. Additionally, medical specialists with degrees in medical care, training specialists, and individuals performing administrative and auxiliary activities are part of the personnel.

Doctors and dental practitioners who work in hospital care can register individual practices for non-stationary specialized care if there is a shortage of such services in their area, as assessed by the regional health inspection. They may also work under contracts with group practices, medical diagnostic laboratories, and hospital care establishments. The National Health Insurance Fund can contract with these medical establishments for out-hospital care if there is a demonstrated need based on the National Health Map.

University hospitals must employ physicians with recognized qualifications under primary employment contracts, ensuring that these institutions maintain a high standard of medical expertise. The educational and research activities in university hospitals are coordinated with higher education institutions, following approved plans and programs.

Medical establishments are required to employ qualified physicians and ensure that their staff includes individuals with the necessary educational and professional credentials. The appointment of lecturers in university hospitals follows the procedures outlined in the Higher Education Act, with competitions announced by the respective higher school in coordination with the hospital management.

Personnel working in medical establishments with reduced working hours may work in shifts, with the maximum length of a working shift being up to 12 hours, regardless of the reduced working time. This provision ensures flexibility in staffing while maintaining compliance with labor regulations.

Overall, the framework for personnel in medical establishments in Bulgaria emphasizes the importance of qualified professionals, continuous education, and adherence to regulatory standards to ensure high-quality healthcare services.

Section IV. Hospital board of trustees

This section outlines the establishment and functions of hospital boards of trustees in medical establishments for hospital care in Bulgaria.

Hospital boards of trustees can be set up at medical establishments for hospital care to assist in better satisfying public needs for medical services. The purpose of these boards is to support the hospital’s activities and enhance the quality and accessibility of medical services provided to the community.

The hospital board of trustees is established by the owners of the medical establishment. To form the board, the owners extend invitations through mass media and personally invite owners, donors, representatives of non-governmental organizations, and other relevant individuals. These invitees then elect the number and members of the hospital board of trustees from among themselves.

The hospital board of trustees meets at least once a year. Meetings can be initiated by one-third of its members, at the request of the hospital’s managing body, or at the request of the owner. During these meetings, the board invites the hospital’s managing body to provide information about the condition and operations of the establishment.

The hospital board of trustees has several key responsibilities: - Assisting in the creation and maintenance of the hospital’s installations, equipment, and real estate. - Proposing measures to the owner for improving the hospital’s activities. - Conducting actions and information campaigns, if necessary, to mobilize public support and resources for the hospital.

By fulfilling these roles, the hospital board of trustees plays a crucial part in ensuring that medical establishments operate effectively and continue to meet the healthcare needs of the community.

Chapter IX is repealed

Chapter X.

Medical establishments in Bulgaria play a crucial role in medical education, encompassing clinical training for students and postgraduate education for healthcare professionals. These establishments can engage in clinical education for students and PhD candidates in medicine, dentistry, and pharmacy, as well as students in health care disciplines. They also provide postgraduate education for doctors, dental practitioners, pharmacists, and health care specialists.

To carry out these educational activities, medical establishments must receive approval from the Minister of Health. The criteria and conditions for approval, including the necessary structure, organization, equipment, and personnel qualifications, are determined by an ordinance from the Minister of Health. The Council of Ministers, based on a proposal from the Minister of Health, designates which medical establishments or their specific clinics or wards will acquire the status of university hospitals for the duration of the approval period. This proposal is made following a request from the rector of the respective higher school, coordinated with the head of the medical establishment.

The Council of Ministers may also withdraw the university hospital status before the approval period expires. University hospitals admit patients with diseases included in training programs for students and postgraduate students. The conditions and procedures for conducting education, as well as its financing, are outlined in contracts between the medical establishment and the higher school. Financing for student and doctoral training comes from the state budget allocated for education and science, while training for healthcare specialties at state-funded positions is financed from the healthcare budget.

The criteria for medical establishments to acquire university hospital status are specified by an ordinance from the Council of Ministers. To obtain approval, the head of the medical establishment must submit an application to the Minister of Health, including justification for compliance with the criteria and a document for a paid state fee. An expert commission appointed by the Minister of Health verifies compliance, and an advisory council provides an opinion on approval or refusal. The advisory council includes representatives from the Ministry of Health, the Executive Agency “Medical Supervision,” the National Health Insurance Fund, professional medical associations, and patient rights organizations.

The Minister of Health issues an order approving or refusing the application within two months of submission. Refusals can be appealed under the Administrative-Procedure Code. Approved medical establishments are listed in a public register maintained by the Ministry of Health, which includes details of the approval order, the name of the establishment, and the types of training and specialties offered. The approval is valid for five years, but the Minister of Health may revoke it if the establishment no longer meets the criteria.

This framework ensures that medical establishments in Bulgaria contribute effectively to the education and training of healthcare professionals, maintaining high standards and supporting the national healthcare system.

Chapter XI.

Medical establishments, regardless of ownership, are required to collaborate and pool their resources during natural disasters, epidemics, and other extraordinary circumstances when societal interests demand joint activities. The expenses incurred by medical establishments in such situations are reimbursed by the state, following a decision by the Council of Ministers.

Medical establishments have the option to enter into agreements with each other to provide medical specialists, services, and other activities. They can also sign contracts with licensed insurers to offer additional services. State and municipal hospitals are permitted to treat patients on a direct payment basis, but this is limited to no more than 10 percent of their available beds. The heads of departments and clinics are responsible for managing the use of these beds.

Medical establishments may establish and participate in self-assessment and rating systems to evaluate the quality of their medical, organizational, financial, and administrative activities. Participation in these systems is voluntary and can involve collaboration with other medical establishments, professional organizations, and patient groups. The criteria for participation, functioning, and assessment elements are determined by the involved parties. Medical establishments must disclose their participation in these systems and keep updated information available online to inform patients and other stakeholders. They are also required to publish information on their ratings based on relevant indicators on their websites.

Chapter XII.

Medical establishments can be financed through multiple sources, including the National Health Insurance Fund, state and municipal budgets, licensed insurers, and contributions from local and foreign corporate bodies and individuals. The revenue of medical establishments is generated from contracts for provided medical care, direct payments by individuals and corporate bodies, reimbursement of expenses by third parties, subsidies from the state and municipal budgets, rentals of equipment and premises, donations, wills, and other sources.

Medical establishments that provide services without a contract with the National Health Insurance Fund must establish their own pricing for these services. They are required to develop internal rules for the allocation of financial resources and must publicly display information on the types and prices of all services provided, both within their facilities and on their websites. Additionally, they must issue financial documents to patients for all amounts paid in connection with their services.

The cost of medical services does not include expenses for the education of students, specialists, and doctoral candidates, long-term qualification, or scientific research. These expenses are subject to individual contracting between the assignor and the medical establishment.

State and municipal medical establishments may receive targeted subsidies approved by the State Budget Act and municipal budgets. These subsidies can be used for acquiring long-term material assets, basic repairs or renovations related to reorganization, information technologies and systems, and financial recovery of hospital care establishments. Medical establishments located in regions of increased health risk may also receive targeted subsidies.

The financing of activities related to investment expenses can be implemented according to the state or municipal participation in the capital of the medical establishments. Funds provided from the state or municipal budget for settling obligations of state medical establishments or those with mixed state and municipal ownership are accounted as an increase in their capital. Medical equipment and other long-term tangible assets purchased through central supply are provided by the Ministry of Health to state and municipal medical establishments according to their purpose. If a medical establishment fails to pay for the equipment within three months, its capital is increased by the value of the equipment, and the state subscribes for new shares.

The budget funds provided for capital expenditures are also accounted as an increase in the capital of the medical establishments. Unused funds for capital expenditures must be refunded to the state budget. The provisions of the Commerce Act and the statute or company contract regarding capital increases do not apply in these cases. The amendments are carried out through an application to the commercial register by the Minister of Health or an authorized official.

The funding and capital increases must comply with the requirements of the State Aid Act. Dialysis centers can be financed by the National Health Insurance Fund based on contracts in compliance with the fund’s budget.

This comprehensive financing framework ensures that medical establishments in Bulgaria have access to diverse funding sources and mechanisms, enabling them to maintain and improve their facilities, equipment, and services to meet the healthcare needs of the population.

Chapter XIII.

Section I: Transformation of the public health establishments

Public medical establishments for hospital care, dispensaries, and hospital diagnostic and treatment structures affiliated with higher education institutions are to be transformed into sole owner trade companies by an order of the Minister of Health. This transformation must be completed by a specified date, and the newly formed companies must apply for permits to carry out medical activities within one month of their court registration. Until the permits are obtained, these establishments can continue their medical activities.

The transformation process includes the enactment of specific ordinances that define the requirements and procedures for these changes. For hospital diagnostic and treatment structures at higher education institutions, national centers carrying out medical activities, state pulmonary hospitals, and the Scientific Institute for Emergency Medical Care “Pirogov,” the ownership of their capital is acquired by the state, with the Minister of Health exercising the rights.

Public health establishments transformed into joint-stock companies have their capital ownership divided between the state and the municipalities of the region served by the establishment. The state’s share is managed by the Minister of Health, while the municipalities’ share is proportional to the population they serve. Other public health establishments are transformed into medical establishments for hospital care or specific types of medical establishments, with their capital owned by the municipality where the headquarters are located.

Public health establishments for non-stationary care are also transformed into sole owner trade companies by an order of the Minister of Health. These establishments must be registered with the regional health inspections and can only operate as specific types of medical establishments. The terms of employment for medical specialists in these establishments are governed by the Labor Code.

Physicians and dental practitioners working in transformed medical establishments for out-hospital care must conclude rental contracts for premises, equipment, and apparatuses with the managing bodies of the establishments. These contracts are subject to specific pricing and conditions, and managing bodies cannot unilaterally terminate them if there is a contract with the National Health Insurance Fund. In case of refusal to conclude a rental contract, the affected parties can seek a court order to finalize the contract.

The property of non-transformed public health establishments for out-hospital care is managed by the mayor of the municipality or an authorized person, with medical specialists having rights to rental contracts for premises and equipment.

Public sanatorium and medical recovery health establishments are transformed into sole owner trade companies with state property by an order of the Minister of Health. These establishments must apply for permits to carry out medical activities within six months of transformation.

The real estate and chattel of transformed public health establishments are transferred to state property, and the newly formed trade companies become legal successors of the original establishments. The legal terms of employment for staff in these transformed establishments are governed by the Labor Code.

The renting and administering of real estate and chattel of state or municipal medical establishments, as well as those with mixed state and municipal participation, require approval from the sole owner of the capital or the Board of Directors if the total value exceeds a specified percentage of the company’s long-term assets. Cash proceeds from these activities are used for investments directly related to the establishment’s activities and for satisfying creditor interests with permission from the owner of the capital.

The state and municipalities may fund medical establishments for executing national, regional, and municipal health programs and projects, as well as for performing certain medical activities beyond obligatory health insurance. Funding is provided through contracts between the respective state or municipal body and the medical establishment. The state may also provide subsidies to hospital establishments in hard-to-reach or remote areas, with criteria and procedures determined by an ordinance from the Minister of Health.

The Ministry of Health subsidizes state and municipal medical establishments for specific activities, including emergency medical care, maintenance of medical records, and medical expertise. Subsidies are provided based on one-year contracts within the budget allocated for these activities and in compliance with the State Aid Act.

Public health establishments that are not transformed are closed down by the Council of Ministers and liquidated according to established procedures.

This comprehensive framework ensures that the transformation and privatization of public medical establishments in Bulgaria are conducted in an orderly manner, with clear guidelines for ownership, management, and funding, while maintaining the quality and accessibility of healthcare services.

Health Insurance Act

Chapter I.

The Health Insurance Act in Bulgaria regulates the health insurance system and the associated social relationships. Health insurance in Bulgaria consists of compulsory and voluntary health insurance activities. These activities involve raising health insurance contributions and premiums, managing the collected resources, and spending these resources on purchasing healthcare activities and services, as well as paying for goods as stipulated by the Act, the National Framework Agreements (NFA), and insurance contracts.

Compulsory health insurance is managed by the National Health Insurance Fund (NHIF) and its territorial units, the Regional Health Insurance Funds (RHIF). This type of insurance provides a package of health activities guaranteed by the NHIF budget. The National Revenue Agency is responsible for collecting the compulsory health insurance contributions, which are fixed by statute. The NHIF purchases healthcare activities from medical care providers, ensuring these activities meet specific criteria for type, volume, price, quality, and accessibility.

Voluntary health insurance, on the other hand, involves taking on financial risks related to the provision of certain healthcare services and goods. This is done in exchange for premiums charged based on insurance contracts. This type of insurance allows for additional coverage beyond what is provided by the compulsory health insurance system.

Chapter II.

Section I. General Provisions

The Health Insurance Act in Bulgaria establishes the framework for the health insurance system and the associated social relationships. It defines health insurance as an activity involving the collection of health insurance contributions and premiums, managing these resources, and spending them on healthcare activities and services, as well as paying for goods as stipulated by the Act, the National Framework Agreements (NFA), and insurance contracts. Health insurance in Bulgaria is divided into compulsory and voluntary health insurance.

Compulsory health insurance is managed by the National Health Insurance Fund (NHIF) and its territorial units, the Regional Health Insurance Funds (RHIF). This system guarantees insured persons access to a package of health activities funded by the NHIF budget. The National Revenue Agency is responsible for collecting compulsory health insurance contributions, which are fixed by statute. The NHIF purchases healthcare activities from medical care providers, ensuring these activities meet specific criteria for type, volume, price, quality, and accessibility.

Voluntary health insurance involves taking on financial risks related to the provision of certain healthcare services and goods in exchange for premiums charged based on insurance contracts. This type of insurance allows for additional coverage beyond what is provided by the compulsory health insurance system.

The principles of compulsory health insurance include compulsory participation in raising contributions, participation of the state, insured individuals, and employers in managing the NHIF, solidarity among the insured, responsibility for personal health, non-discrimination in accessing medical care, non-discrimination of medical care providers in contracting with RHIFs, self-management of the NHIF, contractual relationships between the NHIF and medical care providers, a guaranteed package of health activities funded by the NHIF budget, free choice of medical care providers by the insured, and public openness and control over NHIF operations and expenditures.

Section II. National Health Insurance Fund

The National Health Insurance Fund (NHIF) in Bulgaria is a legal entity based in Sofia, responsible for implementing compulsory health insurance. The NHIF comprises a Head Office, Regional Health Insurance Funds (RHIF), and their divisions. The Council of Ministers determines the headquarters of the RHIFs, while the NHIF Manager decides the locations of their divisions.

The NHIF’s management bodies include the Supervisory Board and the Manager. Employees of the NHIF and RHIFs work under civil-service or employment relationships, adhering to the Labour Code. The NHIF is prohibited from providing voluntary health insurance.

The Supervisory Board consists of nine members, including representatives from patient rights organizations, workers’ organizations, employers’ organizations, and the state. The Board is elected for a five-year term, with provisions for pre-term release under specific conditions. The Board’s functions include adopting NHIF operational rules, participating in drafting the National Framework Agreement (NFA), approving the NHIF budget, controlling the Manager’s activities, and making decisions on significant contracts and expenditures.

The NHIF Manager, elected by the National Assembly for a five-year term, oversees the NHIF’s operations, drafts the annual budget, prepares financial statements, and represents the NHIF domestically and internationally. The Manager is assisted by an Assistant Manager and can be pre-term released under certain conditions.

The Director of each RHIF represents the NHIF locally, organizes RHIF operations, and manages contracts with medical care providers. Directors must hold a master’s degree and have relevant experience. They are appointed through a competitive process.

Eligibility for NHIF and RHIF management positions excludes non-Bulgarian nationals, individuals with prohibitory injunctions, those convicted of premeditated public law offenses, and others with conflicts of interest. These restrictions ensure that NHIF and RHIF leaders maintain integrity and avoid conflicts of interest in their roles.

Section III. Financial Structure of the National Health Insurance Fund

The financial structure of the National Health Insurance Fund (NHIF) in Bulgaria is designed to ensure the effective management and allocation of resources for compulsory health insurance. The NHIF operates with a budget that is separate from the state budget, serving as a financial master plan for raising and disbursing funds related to compulsory health insurance.

The NHIF’s revenues come from various sources, including insurance contributions, transfers from the state budget for specific groups, interest income, income from property management, refunds of insurance expenses, proceeds from fines and penalties, fees, portions of residual assets from liquidated debtor corporations, action subsidies from the state budget, donations, legacies, and other sources. In case of resource deficiencies, the NHIF can contract short-term interest-free loans from the state budget.

The NHIF’s expenditures cover the purchase of medical care as specified in the National Framework Agreement and contracts with providers, administrative costs of health insurance activities, issuance of documents, expenses for the NHIF’s needs, fees for servicing the collection of health insurance contributions, medical care provided under social security coordination rules, and other expenses. The NHIF budget also includes a mandatory reserve for contingency and urgent expenses, set at three percent of collected revenue from health insurance contributions and transfers from other budgets.

Temporarily free resources of the NHIF are deposited at the Bulgarian National Bank and may be used to acquire government securities. The banks handling NHIF resources are designated jointly by the Bulgarian National Bank and the Ministry of Finance, with the NHIF Supervisory Board selecting the banks to be entrusted with these resources.

The NHIF Manager, as the first-level spending unit, oversees the NHIF’s budget, while the directors of the regional health insurance funds act as second-level spending units. The NHIF Manager submits a draft of the National Health Insurance Budget Act to the Council of Ministers, which is then debated by the National Assembly alongside the state budget and public social insurance budget. The NHIF budget act sets forth the rate of compulsory health insurance contributions, revenues, expenditures, and specific allocations for various types of medical care.

If the NHIF budget act is not passed by the National Assembly before the start of the budget year, insurance revenues and expenses are managed based on the previous year’s budget. The NHIF Manager submits the annual budget implementation report and activity report to the National Assembly by June 30 of the following year.

The NHIF is prohibited from owning treatment and healthcare facilities or pharmacies. It is responsible for collecting, processing, and controlling reports from hospital medical care providers regarding activities subject to the National Framework Agreement. This financial structure ensures that the NHIF operates efficiently, transparently, and in alignment with Bulgaria’s healthcare needs and policies.

Section IV. Insured Persons. Rights and Obligations

The Health Insurance Act in Bulgaria outlines the rights and obligations of insured persons under the compulsory health insurance system managed by the National Health Insurance Fund (NHIF). This system covers all Bulgarian nationals who are not citizens of another state, those who are citizens of another state but reside permanently in Bulgaria, foreign citizens or stateless persons with long-term or permanent residence permits, individuals with recognized refugee or humanitarian status, foreign students and doctoral candidates studying in Bulgaria, and other persons covered by the rules for coordination of social security schemes. However, individuals subject to health insurance in another member state are not covered by the NHIF.

The obligation to obtain health insurance arises at different times depending on the individual’s status. For Bulgarian citizens, it begins at birth or the date of the Act’s entry into force. For foreign residents, it starts upon receiving a residence permit, and for refugees, it begins when the procedure for recognition of their status is initiated. Foreign students are covered from the date of enrollment in their educational institution. The rights of insured persons commence from birth, the initiation of refugee status procedures, enrollment in educational institutions, or the payment of health insurance contributions.

Insured persons have several entitlements, including access to medical care within the NHIF-guaranteed package, the right to choose a primary care physician, emergency care, information about NHIF contracts with medical providers, participation in NHIF management through representatives, lodging complaints about legal or contractual violations, obtaining necessary documents for exercising health insurance rights, and cross-border healthcare. Complaints can be lodged with the Director of the respective Regional Health Insurance Fund (RHIF) if there are issues with medical activities, such as unperformed accounted activities, substandard care, denied access to medical documentation, or unjustified charges.

Insured individuals must follow medical care providers’ directions and fulfill disease prevention requirements as per the National Framework Agreement and provider contracts. They are also obligated to provide the National Revenue Agency with health insurance particulars monthly and file declarations for health insurance installments. Foreigners staying in Bulgaria and dual nationals not covered by Bulgarian health insurance must pay for medical care unless covered by an international treaty.

Insured persons must pay fees for each visit to a physician or dentist and for each day of hospital treatment, up to ten days annually. Lower fees apply to pensioners. Exemptions from fees are granted to individuals with specific diseases, minors, war veterans, detainees, indigent persons, and medical specialists. Physicians and dentists must issue receipts for fees paid, and any difference between standard and reduced fees is covered by the executive budget.

The health insurance status required for exercising rights is based on data from applications, declarations, public records, written evidence, and paid or payable contributions. This comprehensive framework ensures that insured persons in Bulgaria have access to necessary healthcare services while fulfilling their obligations under the compulsory health insurance system.

Section V. Health Insurance Contributions

The Health Insurance Act in Bulgaria outlines the rights and obligations of insured persons under the compulsory health insurance system managed by the National Health Insurance Fund (NHIF). This system covers all Bulgarian nationals who are not citizens of another state, those who are citizens of another state but reside permanently in Bulgaria, foreign citizens or stateless persons with long-term or permanent residence permits, individuals with recognized refugee or humanitarian status, foreign students and doctoral candidates studying in Bulgaria, and other persons covered by the rules for coordination of social security schemes. However, individuals subject to health insurance in another member state are not covered by the NHIF.

The obligation to obtain health insurance arises at different times depending on the individual’s status. For Bulgarian citizens, it begins at birth or the date of the Act’s entry into force. For foreign residents, it starts upon receiving a residence permit, and for refugees, it begins when the procedure for recognition of their status is initiated. Foreign students are covered from the date of enrollment in their educational institution. The rights of insured persons commence from birth, the initiation of refugee status procedures, enrollment in educational institutions, or the payment of health insurance contributions.

Insured persons have several entitlements, including access to medical care within the NHIF-guaranteed package, the right to choose a primary care physician, emergency care, information about NHIF contracts with medical providers, participation in NHIF management through representatives, lodging complaints about legal or contractual violations, obtaining necessary documents for exercising health insurance rights, and cross-border healthcare. Complaints can be lodged with the Director of the respective Regional Health Insurance Fund (RHIF) if there are issues with medical activities, such as unperformed accounted activities, substandard care, denied access to medical documentation, or unjustified charges.

Insured individuals must follow medical care providers’ directions and fulfill disease prevention requirements as per the National Framework Agreement and provider contracts. They are also obligated to provide the National Revenue Agency with health insurance particulars monthly and file declarations for health insurance installments. Foreigners staying in Bulgaria and dual nationals not covered by Bulgarian health insurance must pay for medical care unless covered by an international treaty.

Insured persons must pay fees for each visit to a physician or dentist and for each day of hospital treatment, up to ten days annually. Lower fees apply to pensioners. Exemptions from fees are granted to individuals with specific diseases, minors, war veterans, detainees, indigent persons, and medical specialists. Physicians and dentists must issue receipts for fees paid, and any difference between standard and reduced fees is covered by the executive budget.

The health insurance status required for exercising rights is based on data from applications, declarations, public records, written evidence, and paid or payable contributions. This comprehensive framework ensures that insured persons in Bulgaria have access to necessary healthcare services while fulfilling their obligations under the compulsory health insurance system.

Health insurance contributions are determined based on various factors, including income and employment status. Employers and employees share the cost of contributions, with specific ratios defined for different periods. Self-employed individuals, pensioners, and other specific groups have distinct contribution requirements. Contributions are remitted to the National Revenue Agency and are used exclusively for implementing health insurance activities. The state budget covers contributions for certain groups, such as war veterans, disabled individuals, and students. Bulgarian citizens residing abroad for extended periods can opt out of paying contributions but must meet specific conditions for reinstatement upon return.

Section VI. Scope of Medical Care Covered by Compulsory Health Insurance

The Health Insurance Act in Bulgaria outlines the scope of medical care covered by compulsory health insurance, managed by the National Health Insurance Fund (NHIF). The NHIF pays for various types of medical care, including disease prevention, early disease detection, non-hospital and hospital care for disease detection and treatment, long-term and rehabilitative care, urgent medical care, maternity care, therapeutic abortion, dental care, nursing care at home, prescription and dispensation of medicinal drugs and medical goods for home treatment, medical expert certification of working ability, transportation services on medical indications, and medical activities and medicinal products outside the scope of mandatory health insurance.

The NHIF guarantees a package of medical care funded by its budget, defined by an ordinance from the Minister of Health. This package includes criteria for identifying diseases for which the NHIF will fully or partially pay for medications, medical products, and dietetic foods for special medical purposes. The list of diseases is determined by the NHIF Supervisory Board and published in the State Gazette. Changes to this list that increase NHIF expenditure on medicinal products cannot take effect before the amendment of the NHIF Budget Act or the entry into force of the next budget year.

The NHIF negotiates discounts on medicinal products with marketing authorization holders, and these discounts are allocated between the NHIF and insured persons. Pharmacies contracted with the NHIF cannot charge insured persons the amount of the negotiated discount. The NHIF also negotiates discounts for medical products used in hospital treatment of malignant diseases and other specified healthcare activities.

The procedure for providing medical care and the requirements for providers are specified in the National Framework Agreement and contracts between the Regional Health Insurance Funds (RHIF) and providers. The quality of medical care purchased by the NHIF must meet national medical standards and rules of good medical practice, which include requirements for prompt, sufficient, and high-quality care.

The RHIFs purchase medical care for insured persons and transfer funds to the providers. The NHIF periodically informs insured persons about measures to protect and restore their health. Insured individuals must present an identity document when using medical care, and providers must check their health insurance status based on data from the National Revenue Agency.

The NHIF does not purchase medical care beyond the scope defined in the Act or the National Framework Agreement (Contract), nor does it cover expenditure on clinical trials of medicinal products and medical devices. Uninsured persons must pay for medical care according to pricelists drafted by the medical care institutions.

Section VII. National Framework Agreement

The National Framework Agreement (NFA) is a crucial component of the health insurance system in Bulgaria, facilitating the collaboration between the National Health Insurance Fund (NHIF) and professional medical organizations. The NFA outlines the terms and conditions under which medical and dental activities are performed and funded by the NHIF.

The NHIF and the Bulgarian Medical Association adopt and sign the NFA for medical activities, while the NHIF and the Bulgarian Dental Association sign the NFA for dental activities. These agreements are concluded for one year and can be updated as necessary. The drafting of the NFA for medical activities involves ten representatives each from the NHIF and the Bulgarian Medical Association, while the NFA for dental activities involves ten representatives each from the NHIF and the Bulgarian Dental Association. The NHIF representatives include members of the Supervisory Board and the NHIF Manager.

The NFA must be adopted by a majority of at least seven representatives from both the NHIF and the professional organizations. The agreements are adopted by the end of February each year, come into force on April 1, and take into account the NHIF budget for the corresponding year. The Minister of Health coordinates the adopted NFA within 14 days of submission and promulgates it in the State Gazette. If the NFA is not adopted within the prescribed timeline, the currently effective NFA remains in force.

The NFA specifies the conditions that medical care providers must satisfy, the types of medical care covered, the terms and procedures for delivering care, the volumes, prices, and methods for estimating the value of medical care, quality and accessibility criteria, documentation and information exchange requirements, control measures, penalties for contract breaches, and other important aspects of health insurance.

The NHIF plans, negotiates, and purchases medical care for insured persons within the volumes agreed upon in the NFA and in accordance with the NHIF budget for the year. Medical care providers can prescribe medicinal products, items, and dietetic foodstuffs for special medical purposes that are fully or partially reimbursed by the NHIF.

This framework ensures that the NHIF and professional medical organizations work together to provide high-quality, accessible healthcare services to insured persons in Bulgaria, while maintaining transparency and accountability in the health insurance system.

Section VIII. Contract between National Health Insurance Fund and Medical Care Provider

The National Health Insurance Fund (NHIF) in Bulgaria enters into contracts with medical care providers to ensure the delivery of healthcare services to insured persons. Medical care providers include medical-treatment facilities or their associations and national centers for public health.

Contracts between the NHIF and medical care providers are concluded by the Director of a Regional Health Insurance Fund (RHIF) in accordance with the National Framework Agreement (NFA) and relevant legislation. These contracts must align with the terms adopted by the NFA and remain in force until a new NFA is signed or the existing one is modified. Contracts are executed in writing and specify the requirements and conditions for medical care provision, including accessibility and quality criteria.

Medical care providers must meet specific criteria to enter into contracts with the NHIF, such as having medical specialists on primary employment contracts, possessing necessary medical apparatuses and technology, providing continuous 24-hour emergency medical assistance, and adhering to established medical standards and good medical practice rules.

The NHIF and RHIFs are responsible for informing providers of any changes arising from decisions of their governing bodies or modifications in the NFA. Contracts may be terminated or amended if providers fail to meet the required criteria or if there are violations of medical care quality standards.

Medical care providers must submit applications to the RHIF for contract signing within 30 days of the NFA’s entry into force. The RHIF Director signs contracts with providers that meet the criteria for accessibility and quality of medical care. Refusals to sign contracts can be appealed through the administrative court system.

The NHIF also has the authority to impose penalties or terminate contracts with providers in cases of reported activities not performed, repeated violations, or systematic patient dissatisfaction with medical care. Contracts may only be concluded for hospital medical care activities for which the provider has specialists working under primary employment contracts.

This framework ensures that the NHIF collaborates with qualified medical care providers to deliver high-quality, accessible healthcare services to insured persons in Bulgaria, while maintaining transparency and accountability in the health insurance system.

Section IX. Information Support of the Operation of the National Health Insurance Fund

The National Health Insurance Fund (NHIF) in Bulgaria is responsible for building and maintaining an information system that supports its operations. This system includes several key components:

1. A register of insured persons, which contains identity card details, a unique personal identification number, grounds for entitlement to health insurance, contributions paid, and information on medical care delivered to insured persons in other EU member states.
2. A register of persons insured in other EU member states who are entitled to receive medical care in Bulgaria at the expense of the NHIF.
3. A register of medical care providers, including their identity card details, professional information, and contracts with the NHIF.
4. A register of specialists working at medical treatment facilities under NHIF contracts, detailing their names, professional details, field of specialization, and the type of medical care they provide.
5. A register of manufacturers, importers, and distributors of medicinal drugs and pharmacies that have contracts with the NHIF.
6. Information about the activities performed by the controlling authorities.
7. Administrative information essential for the operation of the NHIF.

The NHIF provides access to this information system for the Ministry of Health. Each insured person has the right to receive information from the NHIF about the medical and dental care they have used in the past five years and the cost of that care. Insured persons can also access information about medical care providers and pharmacies that have contracts with the RHIF for their region.

Medical care institutions are required to post information in public places within their buildings and on their websites about the healthcare activities guaranteed by the NHIF budget, the cost of these activities, free medical services, cases where targeted funds from the state budget are available, situations where individuals must pay for medical care outside the scope of compulsory health insurance, and information on insurers with whom they have contracts.

Medical care providers must provide the NHIF with information about the work they perform, in accordance with the conditions, procedures, and volume specified in the National Framework Agreement. The information system uses established national codes and nomenclatures for registering and reporting healthcare services activities. Data and documentation required by the National Framework Agreement may be submitted electronically to the RHIF.

The NHIF preserves particulars regarding insured persons for five years after the termination of their health insurance and particulars regarding providers for five years after the termination of their contracts with the NHIF. These particulars are used solely for purposes such as establishing insurance relationships, paying medical care providers, preparing electronic health insurance cards, identifying sums for collection or reimbursement, and exercising financial and medical control.

The NHIF is obligated to provide information requested by the Ministry of Health and must ensure that its employees do not disclose personal particulars of insured persons, medical care providers, or employers except as prescribed by statute. The NHIF and RHIF employees are also prohibited from giving professional evaluations or directing patients to specific providers.

The Executive Director of the National Revenue Agency drafts and submits information to the Ministry of Health and NHIF about the amount of collected health insurance contributions and collectability trends. This comprehensive information support system ensures that the NHIF operates efficiently, transparently, and in alignment with Bulgaria’s healthcare needs and policies.

Section X. Control, Expert Evaluations and Disputes

The Health Insurance Act in Bulgaria includes provisions for control, expert evaluations, and dispute resolution to ensure the proper implementation and management of the National Health Insurance Fund (NHIF).

Control over the NHIF’s budget implementation is exercised by the National Audit Office, while comprehensive financial control is conducted according to the Public Financial Inspection Act. The Supervisory Board oversees the performance of the NHIF Manager and the directors of the Regional Health Insurance Funds (RHIF).

The NHIF Manager exercises comprehensive control over compulsory health insurance activities and assigns inspections based on audit reports. Control over contracts with medical and dental care providers is performed by NHIF and RHIF officials, who can conduct surprise inspections, pre-payment control, and ex-post control. Experts from professional organizations may participate in inspections and provide written opinions.

Control authorities have the power to check payments, examine accounting documents, ensure legal conformity of financial activities, investigate complaints, and verify compliance with accessibility and quality criteria. They can access information from employers, insured persons, and providers, but must maintain confidentiality.

Financial control over NHIF revenues from health insurance contributions is exercised by the National Revenue Agency. Control activities are conducted through planned and surprise inspections, and findings are documented in records provided to the inspected person and relevant authorities.

Disputes arising from control findings can be referred to arbitration committees, which include representatives from the RHIF and professional organizations. The committees resolve disputes within one month, and penalties are imposed based on their resolutions. Penalties can be appealed in court.

Medical and dental care providers who receive sums without legal grounds must repay the amounts. Written invitations for repayment are issued by the NHIF Governor or RHIF Director, and these invitations can be appealed.

Joint checks by the RHIF, Medical Audit Executive Agency, regional healthcare inspectorates, and professional organizations ensure compliance with medical standards and good practices. Violations result in penalties imposed by the relevant control body.

The NHIF may conduct expert evaluations for high-value medical care or expensive medicinal products. Disputes related to contract performance between the RHIF and care providers are resolved in court if arbitration fails.

This framework ensures that the NHIF operates transparently and efficiently, maintaining high standards of healthcare services and accountability in Bulgaria’s health insurance system.

Section XI. Issuance of Documents Required for Exercise of Health Insurance Entitlement according to Rules for Coordination of Social Security Schemes

The National Health Insurance Fund (NHIF) and the Ministry of Health in Bulgaria are responsible for issuing documents required for exercising health insurance entitlements according to the rules for coordination of social security schemes. These documents must be issued within thirty days of a request submitted by the interested parties to the Regional Health Insurance Funds (RHIF). The Minister of Health, upon the NHIF Manager’s motion, establishes the procedure for issuing these documents.

The NHIF Manager or an authorized official issues European health insurance cards, which are valid for one year. For applicants under 18 years old, the card is valid until they turn 18, with a minimum validity of one year and a maximum of five years. For recipients of contributory-service and retirement-age pensions, the card is valid for ten years. For those receiving invalidity pensions, the card’s validity matches the pension period, with a minimum of ten years.

A European health insurance card can be declared invalid if it is reported lost, stolen, or destroyed, if the insured person dies, or if the person loses entitlement to NHIF-covered medical care. The card will not be issued to individuals who have opted out of the health insurance system or lost their entitlement. The card is recommended for insured persons during temporary stays in EU Member States, the European Economic Area, and Switzerland.

Section XII. Cross-border Healthcare

The National Health Insurance Fund (NHIF) and the Ministry of Health in Bulgaria are responsible for issuing documents required for exercising health insurance entitlements according to the rules for coordination of social security schemes. These documents must be issued within thirty days of a request submitted by the interested parties to the Regional Health Insurance Funds (RHIF). The Minister of Health, upon the NHIF Manager’s motion, establishes the procedure for issuing these documents.

The NHIF Manager or an authorized official issues European health insurance cards, which are valid for one year. For applicants under 18 years old, the card is valid until they turn 18, with a minimum validity of one year and a maximum of five years. For recipients of contributory-service and retirement-age pensions, the card is valid for ten years. For those receiving invalidity pensions, the card’s validity matches the pension period, with a minimum of ten years.

A European health insurance card can be declared invalid if it is reported lost, stolen, or destroyed, if the insured person dies, or if the person loses entitlement to NHIF-covered medical care. The card will not be issued to individuals who have opted out of the health insurance system or lost their entitlement. The card is recommended for insured persons during temporary stays in EU Member States, the European Economic Area, and Switzerland.

Health insured persons in Bulgaria are entitled to access safe and high-quality cross-border healthcare. Cross-border healthcare refers to healthcare provided or prescribed in an EU Member State other than the person’s home country. This entitlement applies to healthcare included in the NHIF or Ministry of Health’s funded package. However, it does not cover organ transplants, long-term care for chronic conditions, national and municipal vaccination programs, or cases covered by existing social security coordination mechanisms or bilateral agreements.

When seeking cross-border healthcare, insured persons must pay the medical facility in the treatment country and can claim reimbursement up to the amount the NHIF or Ministry of Health would pay for equivalent care in Bulgaria, but not exceeding the actual costs incurred. Reimbursement is not available for care provided by non-contracted institutions in Bulgaria.

The Minister of Health issues an ordinance detailing the terms, conditions, and procedures for exercising the right to cross-border healthcare. Prior authorization may be required for certain healthcare services, medicinal products, and medical products, especially those involving significant planning, high costs, or potential risks. The NHIF or Ministry of Health may refuse prior authorization if the treatment poses safety risks, can be provided in Bulgaria within a medically justifiable timeframe, or if the foreign provider raises quality or safety concerns. Refusals can be appealed under the Administrative Procedure Code.

The NHIF serves as the national contact point for cross-border healthcare, providing relevant information to patients and coordinating with other national contact points and the European Commission. The Ministry of Health, regional health inspectorates, the Agency for People with Disabilities, medical facilities, and professional organizations must provide necessary information to the NHIF to support its role as the national contact point.

Chapter III.

Section I. General Provisions

Voluntary health insurance in Bulgaria is regulated under Chapter Three of the Health Insurance Act. This type of insurance is based on medical insurance contracts as defined in the Insurance Code. It does not include medical insurance for travel outside Bulgaria or services provided by medical care providers under specific contracts with individuals or legal entities.

Voluntary health insurance activities can be carried out by licensed insurance joint-stock companies. These insurers have the right to request written information and documents from medical care providers and suppliers of healthcare goods regarding the services provided or goods delivered to insured persons. This information includes diagnosis, prescribed treatment, medical documentation, medicines, medical products, consumables, materials used for treatment, the type and scope of the service, and the effective price list.

The provision of healthcare services under voluntary health insurance is performed by medical care providers. The type, prices, terms, and procedures for these services are established in contracts between the medical care providers and the insurers. This framework ensures that voluntary health insurance in Bulgaria operates within a regulated system, providing additional coverage options beyond compulsory health insurance.

Chapter IV.

Chapter Four of the Health Insurance Act in Bulgaria focuses on medical control and the role of the Medical Audit Executive Agency. This agency is responsible for ensuring that the National Health Insurance Fund (NHIF) provides the guaranteed package of healthcare activities and that insurers comply with their health insurance contracts. The agency also reports any unauthorized voluntary health insurance activities to the Financial Supervision Commission and prepares opinions on the feasibility of medical insurance contracts.

The Medical Audit Executive Agency has the authority to inspect contracts between the NHIF, Regional Health Insurance Funds (RHIF), and medical care providers. It can also require semi-annual reports from the NHIF and insurers, detailing the number of persons attended to and the services provided. The agency’s employees have the right to conduct on-site inspections and request necessary documents and information to perform their duties.

The NHIF, RHIFs, and insurers must cooperate with the agency and provide the requested information. The agency’s employees are bound by confidentiality and can only disclose information with the consent of the providers or as required by law. This framework ensures that the NHIF and insurers operate transparently and comply with regulations, maintaining high standards of healthcare services in Bulgaria.