Legal procedures for the opening of a non-public hospital

Legal procedures for the opening of a non-public hospital in addition to promoting health care and social issues, non-public hospitals are considered “business” for this reason, law No. 10 081; dated 23.2.2009 stipulates that the non-public hospital is an economic activity for which it is necessary to obtain a permit from the BCC.
1-Licensing is a mandatory process for legal entities that provide health services in the Republic of Albania.

Required documentation:
1-Ownership document on the land where the building is located
2-Layout of premises signed and stamped by a licensed architect/engineer
3-Identification document, recognized by law, of the person applying on behalf of the subject (Passport or Identity Card).
4-Authorization certifying that the person who submits the request on behalf of the subject, when this is not
the holder of the matter is authorized by this subject to request the license and make the required declarations on behalf of the issue.
5-Statute of the non-public hospital
6-Self-declaration of equipment and facilities
7-Verification and fulfillment of the criteria of adequacy of the medical staff’s knowledge and experience must be original or notarized photocopies. After all, papers are reviewed and verified, approval is given, and the requesting entity is provided with NUIS (NIPT) generation. In this way, the non-public hospital is legally identified.

2-Contract with the pharmacy
As the activity is focused on health, the non-public hospital must provide branches and medicines to treat patients. Therefore it must first have a contract with a pharmacy certified by the Ministry of Health. Law No. 9323, dated 25.11.2004 “On Drugs and Pharmaceutical Service,” stipulates that drugs circulating in the Republic of Albania must be registered, except medicines prepared at the pharmacy, according to the doctor’s prescription and the pharmaceutical form.

The National Center for Drug Control (NCDC) is an institution specialized in the analysis, registration, control of drugs, and inspection of activities in the pharmaceutical field. All medications produced in the country, destined for the Albanian market, and drugs imported from abroad, destined for the domestic market, must have the drug control stamp applied to the packaging.
The drug control stamp must contain, as follows, the following elements:
a) name and form-dose of the drug;
b) the retail price of the drug (including VAT);
c) identification of the holder of the trade authorization, of the authorized manufacturer or importer using a two-digit code;
d) visible serial reference number;
e) barcode

The improvement of the conditions and the administration of medicines’ storage by the hospital according to the defined criteria and standards ensures quality and efficiency in their use by the patient. Of course, the law is applied. The non-public hospital, with the help of controlled and certified drugs, protects the health of their patients and covers the activity because if it offers medicines that are not controlled, it risks having its license revoked training closed.

3-Registration in the General Directorate of Taxes (GDT)
Being a private institution, where it is paid to receive a particular service, law No. 9920, dated 19.5.2008 “On Tax Procedures in the Republic of Albania” as amended, stipulates that the tax liability arises when the legal person realizes income. Legal entities that recognize taxable income in the Republic of Albania’s territory submit the annual income statement to the central tax administration. Each income statement is completed with the identification number of the NUIS building, which serves as the fiscal code of the legal entity
The annual income statement contains:
-gross income data
-d deductible expenses incurred
-taxes paid during the tax period

Non-Public Hospitals must implement law no. 10383, “On Compulsory Health Insurance in the Republic of Albania” Amended where:
Article 4
Compulsory health care insurance
Compulsory health insurance scheme aims to cover the population is benefiting from health care services financed by the public and private sector, based on this law.
Compulsory insurance finances compulsory insurance service packages, which include:
a) visits, examinations, and medical treatments in private primary care providers and private hospitals;
Public hospitals do not have all the equipment for diagnosing or treating rare diseases. Therefore, a general fund has been created, which is financed from the state budget, wherewith the public hospital’s recommendation, the patient is sent to a non-public hospital and offered the treatment he needs. .The stock only covers the expenses of those individuals who are insured.
To enter into a contract with a non-public hospital, there are specific criteria that must be met. The agreement defines the health services, which will be covered by the stock. Contracts are entered into for a fixed period and may be renewed.
The criteria that must be met by non-public health institutions for concluding a contract with the stock are:
a) the BCC must license the non-public health institution for the health service
to be contacted;
b) The non-public health institution must be registered with the tax authorities in the region where it carries out its activity;
รง) The non-public health institution must have a bank account in a second level bank in the Republic of Albania;
d) The non-public health institution must be equipped with the necessary computer equipment and the creation of a database/program, which must be installed and accessible online by the stock;
e) Specialist doctors, who will perform the procedures of health packages approved and contracted by the stock, should not be employed in public health institutions;
f) Specialist doctors, who will perform the procedures of health packages approved and contracted by the stock, have not broken the agreement with the Ministry of Health regarding the benefit of postgraduate specializations;
g) The non-public health institution should not be in bankruptcy and liquidation proceedings.

4-Name registration
It takes another step to complete all the legal procedures for opening a non-public hospital. The image is essential, and of course, you have to have a name in the market to be known and the location determined.
As a start, the name should be reserved with the NBC institution to avoid the registration of two institutions that have the same activity and expression.
After booking the name with the NBC, we must register it as a trademark with the General Directorate of Industrial Property (DPPI) to protect the institution’s name. Law No. 9947, dated 7.7.2008 “On Industrial Property” as amended, sets out the conditions that must be met to register the name.
Criteria for name registration:
-the name must have a distinctive character
-the name must be legal
The application for registration of a trademark contains the following elements:
a) name and address of the applicant;
b) the representation (appearance) of the trademark for which registration is required
c) the list of goods and services for which registration is required
d) the document certifying the payment of the deposit fee
e) signature of the applicant or his representative;
DPPI issues the registration certificate. In this way, the name is legal and does not affect any other entity. Also, the name’s registration as a trademark allows the private institution to be protected by third parties.

5-Rules for the work of medical personnel
Applicable implementation of the Labor Code dealing with the protection of duty and obligation between employees and employers, working hours and salaries, medical personnel have adequate protection and must be qualified.
A non-public hospital should only work as a doctor if:
a) is a licensed and health professional;
b) has not been detained by a decision of a court or other competent body for the exercise of health activity;
c) meets the conditions for the necessary work experience in the respective field, according to the bylaws issued by the Ministry.
Health Professionals
Registration of professionals is a mandatory process, which is carried out by the Ministry of Health. This procedure creates security for all patients and of course the law is enforced through registration. The Ministry of Health approves, by order, regulations on procedures and registrations of health professionals.
Registration, health care professionals are mandatory who do not have to be continuously professionally educated to improve, to improve their professional knowledge and skills, in order to increase the quality of health care. The health care institution has an obligation that favors and creates facilities for the education and professional continuation of health professionals.

– Criteria to be met for obtaining a license
Additional criteria defined by Law No. 9106, dated 17.7.2003 “On the Hospital Service in the Republic of Albania”, if any legal entity that has to make a non-public hospital,
you must submit the application to the Licensing Commission of the Ministry of Health.
The request must contain the following documentation:
a) for the medical activity that makes it take place
b) for hygienic-sanitary conditions
c) for the number of beds
d) for the planimetry of the environment
e) for the regulation of the operation of the hospital
Additional documentation:
Must submit a document that has an employment contract with qualified medical personnel and that will contain the appropriate standard for health care, in accordance with the Code of Ethics.
-It must contain the obligations of legal obligations with the health service that apply to health institutions.
-I must submit the statute of the non-public hospital.
-You must document and lead a direct and general life of the institution and who is the person in charge of each department.

Temporary search and documentation commission within 30 days of their submission. If the request is not accepted, the commission has the obligation that within 5 days from the approval, proposed by the Ministry of Health to give the hospital permit to the public.

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