A short guide
How to establish a medical institution in Serbia?
There are an increasing number of private medical institutions in Serbia, both specialized clinics and general hospitals as well as private health centers. There are a lot of reasons for this, but certainly one of them is a consequence of globalization and trends that have existed in Western European countries for decades, which is an opportunity to choose a treatment option and not rely solely on the national health care system. By adopting a new Law on Health Care (“Official Gazette of the RS”, No. 25/2019) (“Law”), the legislator not only improved this area but also achieved a greater degree of harmonization with EU law, which is in the context of awaiting Serbia’s accession to the European Union very significant.
If you want to establish a medical institution in Serbia, what is important to know at the outset is that this area is regulated, in addition to the Law, by the Rulebook on closer conditions for performing health care activities in health care institutions and other forms of health care service (Official Gazette of the RS No. 43 / 2006, 112/2009, 50/2010, 79/2011, 10/2012 – other regulations, 119/2012 – other regulations, 22/2013 and 16/2018) (the “Rulebook“). While the Law regulates this area in a general way, categorizing different medical institutions and stipulating that they can be founded by privately owned funds, the Rulebook stipulates closer conditions for their establishment, in terms of premises, equipment, staff, but also medicines and medical devices.
The founder of a medical institution can be both a natural person and a legal entity. If you want to establish a medical institution as a legal entity, which is often the case in practice, your first step would be to establish a business company.
After the establishment of the company that will be the founder of the medical institution, it is necessary to collect and prepare all stipulated documentation in order to initiate the procedure before the Health Care Inspection from which the Decision for performing the health care activity is obtained, which is necessary for the registration of the medical institution. First of all, it is necessary to draw up an Article of Association, and what is characteristic about the act of establishment of a medical institution in relation to the founding act of a company is that it also regulates the mutual rights and obligations of the founder with respect to the activities for which the medical institution is established. Also it is necessary in the Act of Association to set a deadline for the adoption of the Statue, deadline for appointment of a director and governing bodies. After that, documentation regarding the premises, professional staff and necessary equipment should be collected. At this point, it is important to consult the Rulebook, as it specifies in detail which institution needs to be provided with how much space and what the space needs to look like, number and education of professional staff, and additionally specifies the necessary equipment to allow the healthcare institution to perform its activities. At this point of the procedure, it is important to provide a sketch of the premises in which the activity will be performed. The legal basis for premises is also significant, so it will be necessary to submit a sale and purchase agreement, or lease agreement for example.
At this stage of the procedure, the Health Care Inspection assesses the fulfillment of the requirements for establishing a medical institution, prescribed by the Law and the Rulebook. In order to obtain the Decision, which is one of the prerequisites for the initiation of the procedure of registration of a medical institution, in addition to the submission of the above documentation, it is also necessary to pay a fee, which differs depending on the establishment of the medical institution concerned.
The Health Care Inspection will issue the Decision within 30 days, and after receiving the Decision, the procedure of establishing a medical institution may be continued. The next step is to register a medical institution with the competent authority.
It is important to note here that one of the major innovations introduced by the Law is the competence of the Serbian Business Registers Agency (the “Agency“) for registering medical institutions. In addition to the registration process, the Agency will be responsible for maintaining a register of medical institution. In this way, the registration process is entrusted to the body established for the registration of business entities, which will simplify and shorten the registration process. The implementation of these provisions of the Law will commence no later than 18 months from the date of its adoption, while the Agency will also be allowed 18 months to establish the Register of medical Institutions.
However, for the time being the registration procedure is still performed before the competent Commercial Court, and the medical institutions are entered in the court registry. The application for registration of a medical institution must be submitted within 15 days from the date of receiving of the Decision for performing health care activity. In addition to the Decision of the Health Inspection, the Act of Association is also submitted to the Commercial Court, but at this stage of the procedure it is necessary to draw up the Statute of the medical institution as the Statute is necessary for its registration. In addition, it is necessary to obtain a bank confirmation of the contribution of the share capital, as well as to submit the certified specimen signature form of the director, the read ID of the director, as well as the legal basis for using the medical institution headquarters and two copies of the notice. The Commercial Court makes a decision on registration within 30 days.
Another important novelty of the Law is that the legislator envisaged that the director may also be a person with higher education in the field of legal, economic, or organizational sciences. With this change, the legislator recognized the need for person in charge of a medical institution to be someone with good organizational and managerial skills, with the ability to contribute to the advancement of the medical institution not only in medical terms.
The new provisions of the Law regarding the authority responsible for registering a medical institution have made the registration process simplified but also shortened, as the Agency makes decisions within 5 working days. From the experience of the Agency’s work so far, list of registration documents as well as instructions for the registration process will be easily accessible on the Agency’s website, making the process much easier for founders. Regarding the legislative framework itself, the provisions of the Law are very clear and unambiguous, while the Rulebook itself adequately regulates requirements for healthcare institutions. Also of great importance is the fact that the stipulated rules apply to both publicly owned and privately owned medical institutions, thereby the legislator avoided any bias in this respect.