Registration and management of Outpatient Clinics for Primary Medical Care and a Medical Center

I. Background.
The principal division of medical establishments in Bulgaria is between hospital-type establishments and those providing outpatient medical care. For their part, outpatient medical establishments are divided into outpatient clinics for primary medical care (article 8, paragraph 1, subparagraph 1 of the Medical Establishments Act, MEA) and outpatient clinics for specialized medical care, which in turn can be individual or group practices for specialized medical assistance, a medical center or a medical-dental center, a diagnostic and consultative center, or stand-alone medical-diagnostic or medical-technical laboratories (MEA article 8, paragraph 1, subparagraph 2).
This presentation deals specifically with the basic requirements concerning the registration and management of outpatient clinics for primary medical care and a medical center.

II. Registration.
Medical establishments of the types of outpatient clinic for primary care and medical center are subject to registration in two registers: the Commercial Register (CR) with the Registry Agency (RA) and the Public Register of Medical Establishments for Outpatient Care and Hospices (PRMEOCH) under the Medical Supervision Executive Agency (MSEA).

2.1. Registration in the Commercial Register (CR).
Pursuant to the requirements of MEA article 40, paragraph 1, subparagraph 1, namely that, to be entered in PRMEOCH, a medical establishment must present current CR registration, a condition precedent for medical establishments of the types of outpatient clinics for primary medical care and medical centers is to have prior registration in the Commercial Register.

1) Specific requirements for the application file seeking registration in the Commercial Register
In addition to the standard documents for registration of a commercial company of the relevant type, for registration of an outpatient clinic for primary medical care, respectively a medical center, the application for registration must be supported by the following documents:
o A diploma for completed medical education of the manager, respectively executive director, of the applying entity;
o A certificate of recognized medical specialization of the manager, respectively executive director;
Failure to submit those documents constitutes grounds for refusal of registration.

2) Specific requirements for the company name
The company must comply with the requirements of article 7 of the Commerce Act, constituting general rules for all types of commercial companies.
In addition to the general requirements, the company name of outpatient clinics for primary medical care and medical centers must contain the type of medical establishment.

3) Requirements concerning the partners
The Medical Establishments Act poses requirements regarding the founding partners of an individual practice for primary medical care. Pursuant to MEA article 3(2), in conjunction with article 8, paragraph 1, subparagraph 1, point (a), those can be:
o natural persons: medical doctors or doctors of dental medicine;
o single proprietors or single proprietorships registered by medical doctors or doctors of dental medicine, in cases where the medical establishment is to be registered as a single proprietorship.
No such restrictions are provided with regard to medical establishments of the type of a group practice for primary medical care, or with regard to a medical center.

4) Regarding the requirement for a minimum number of medical doctors in a Medical Center.
Pursuant to MEA article 16(1), a Medical Center or a Medical-Dental Center is a medical establishment where specialized outpatient medical care is provided by no fewer than three medical doctors and/or three doctors of dental medicine of recognized different fields of specialization. No such requirement has been posed regarding outpatient clinics for primary medical care.

2.2. Registration with the Medical Supervision Executive Agency.
• General characteristics of the registration procedure
Registration under MEA article 40 is carried out by the Medical Supervision EA. The register it keeps is public.

• Documents required for registration
The registration is carried out by the executive director of MSEA on the basis of an application stating the unified identification code of the company as per the Commercial Register and supported by the following documents:
– A certificate of current registration under national law, issued by the competent authority of the relevant country, for companies registered in a member state of the European Union or a state party to the Agreement on the European Economic Area;
– Rules on the organization, operation and internal order of the medical establishment;
– The names of the persons who are partners or shareholders in the company or members of the cooperative seeking to establish a group practice;
– A diploma of higher education for each of the persons who will manage, respectively will work in, the medical establishment;
– A certificate of recognized specialization profile of the persons who will manage, respectively work in, the medical establishment, and in cases as per MEA article 14a, a certificate that the person in question has been admitted to a training course for acquiring a specialization profile in general medicine;
– Proof of payment of stamp duty as per MEA article 41(4), as well as under article 46 of the Health Act.
The application, supported by the documents listed above, is filed with the regional health inspectorate. On the date of receipt of the application, the regional inspectorate will file, ex officio, a request with the Bulgarian Medical Association, respectively the Bulgarian Dental Association, for issuance of certificate of entry into their registers of the relevant medical doctors, doctors of dental medicine, medical assistants, nurses, etc.
The professional associations will then issue the certificates applied for within 5 days from the date of receipt of the request.
• The option of providing guidance
If any of the submitted documents are found to be incomplete or missing, the Medical Supervision Executive Agency will, within 10 days of receipt, notify in writing the applicant of that fact and set a deadline to remedy the incomplete documentation.

• The obligation to notify MSEA in the event of change of circumstances
Registered entities are obligated to notify the Medical Supervision Executive Agency of any changes relevant to the registration of the medical establishment within 7 days from their occurrence, in accordance with article 40. Only documents relevant to the changes need be submitted, accompanied by a declaration of lack of changes in all other documents and circumstances.

• Grounds for refusal of registration
The Executive Director of the Medical Supervision Executive Agency will issue a reasoned refusal of registration if:
1. the documents submitted are incomplete or missing and the omissions are not cured by the prescribed deadline;
2. a person representing the medical establishment has been convicted of a crime of general nature, unless rehabilitated, or has been stripped of the right to practice a certain profession or activity;
3. non-compliance is found with the requirements of MEA, the health requirements and/or the established medical standards as per MEA article 6(1), and this has not been cured within the prescribed deadline;
4. the medical doctors, doctors of dental medicine, medical assistants, nurses and midwives who will manage and/or will work for the medical establishment are not listed in the register of the relevant college of the Bulgarian Medical Association, respectively the Bulgarian Dental Association, the Bulgarian Association of Medical Assistants and Paramedics, or the Bulgarian Association of Health Care Professionals.
A refusal of registration may be appealed before the relevant administrative court in accordance with the Administrative Procedure Code.

Also prescribed in MEA article 46 are the grounds for striking a medical establishment off the register.

III. Management.
The terms, conditions and requirements for the management and operation of a medical activity in the form of an individual or group practice for primary medical care are provided in MEA article 13(1) and article 14(1), and those for the management and operation of a medical center or a medical-dental center are provided in MEA article 16(3).
In accordance with the provisions referred to above:
– An individual practice of primary medical care is organized and carried out by a medical doctor with a recognized specialization profile in general medicine, respectively a doctor of dental medicine, who are registered in accordance with article 40.
– A group practice of primary medical care is carried out by a commercial company or cooperative established by medical doctors with a recognized specialization profile in general medicine, respectively by doctors of dental medicine, registered in accordance with article 40.
– A medical center, a dental center or a medical-dental center is managed by a medical doctor, respectively a doctor of dental medicine, with a recognized specialization profile.
The expression ‘recognized specialization profile’, used in MEA article 13(1), article 14(1), and article 16(3), should also be interpreted in conjunction with article 13(2), article 14(2) and article 16(1) of said provisions, where it is likewise stated that in medical establishments specialized outpatient care is provided by (a) medical doctor(s) of various recognized specialization profiles. Even the expression ‘various recognized specialization profiles’ should be interpreted in the sense of various recognized specialization profiles except that of ‘Social Medicine’; this, therefore, corresponds to fulfilling the requirements for registration of medical establishments (In that sense, see Ruling No. 8/4.01.2021, on administrative lawsuit No. 1803/2020 of the Administrative Cort of the City of Plovdiv).

• Regarding MEA requirements in relation to the manager of the medical establishment
The manager, respectively executive director, of a medical establishment must hold an academic degree not lower than Master of Medicine, respectively Dental Medicine.
It should be noted that the general requirement of MEA article 63(1), for managers of medical establishments, who are medical doctors or doctors of dental medicine, to be qualified in health management, has been specifically dropped, in accordance with paragraph 5 of the same provision, with respect to outpatient clinics for primary medical care, medical centers, dental centers or medical-dental centers.
Internal relations between the medical establishment and its manager are governed by a contract on assigning the management within the meaning of article 141(7) of the Commerce Act.

III. Regarding the possibility for transformation of medical establishments
In the event of transformation of the type of medical establishment (e.g. from an individual practice for primary medical care into a medical center), the relevant medical establishment must cease operation while, at the same time, start a registration procedure in accordance with MEA article 40.
Every established legal entity may only seek registration as one type of medical establishment, to which the Executive Director of the Medical Supervision Executive Agency will issue a certificate of registration.
Transformation is not allowed solely for the registration in the public register of medical establishments for outpatient care and hospices. The change of an entry in the Commercial Register must involve a change in the company name; it is also possible that a change in the form of legal organization may become necessary.