Serbia: Most Important Novelties in New Law on Healthcare Protection

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At the beginning of April 2019, the Serbian Parliament adopted a new Law on Healthcare Protection (“Law”), with the intention of improving the healthcare system by introducing novelties, aligning in that way the legislation of the Republic of Serbia (“RS“) with EU regulations and standards in the area of healthcare

Some of the most important novelties introduced by this Law are the following:

  • More Rational Organization of Healthcare Institutions (“HCIs”).

In order to achieve a better organization and management of privately owned HCIs, the Law prescribes that the regulations governing the legal status of a limited liability company accordingly apply to status changes, change of legal form and termination of existence of private HCIs. In that regard, previously applicable Law on Healthcare Protection was unclear, providing only that the founder decides upon termination, merger and division of privately owned HCIs.

Additionally, HCIs can now be founded in accordance with the legislation governing public-private partnerships.

  • Register of HCIs.

Instead of the previously applicable registration in the court register, which was not publicly available, upon obtaining a license for performing a healthcare activity, HCI and its organizational unit outside its seat are now registered in the Register of Healthcare Institutions (“New Register”) with the Serbian Business Registers Agency (“BRA”) and  published on the website of the BRA. The New Register will start working at the latest from 11 October 2020. Until then, the registration of HCIs with commercial courts shall continue to apply, in accordance with the previous Law on Healthcare Protection.

The Law further prescribes that the New Register of Healthcare Institutions will include detailed information on every HCI, together with, inter alia, the name, form and type of HCI, information on the founders, the number and date of the license issued by the Ministry of Health (“Ministry”) for the fulfillment of the prescribed conditions for performing healthcare activity, etc.

  • Specifying Conditions Related to Prohibition of Advertising.

It is now allowed to advertise:

  • healthcare services,
  • expert-medical procedures and methods of healthcare protection performed in an HCI, or, as the case may be, private practices, as well as
  • contact details of HCI or private practice,

with the aim of providing patients with the necessary information.

This is more liberal compared to the strict rules on advertising of healthcare services contained in the old Law on Healthcare Protection, which allowed only a limited amount of information to be provided to patients (such as the name and type of the HCI, its seat and working hours).

  • Possibility of Engagement of Healthcare Practitioners from Other HCIs.

In principle, an HCI may only perform a healthcare activity determined by the license of the Ministry on fulfillment of the conditions for performing the healthcare activity. However, the Law makes an exception to this general limitation.

For the purpose of improving the healthcare system, a public HCI, as well as a private practice, exceptionally, may hire healthcare practitioners of another specialty from other HCI or private practice, by entering into a cooperation agreement with the other HCI or private practice, or by entering into an agreement for additional work with the healthcare practitioner.

In the same manner, the HCI and the private practice may also hire a healthcare practitioner with the permission to perform methods and procedures of traditional medicine, if necessary, for the diagnosis, treatment and rehabilitation of a patient within the healthcare activity for which the HCI was established.

  • Detailed Regulation of Supplementary Work of Healthcare Practitioners.

The Law allows healthcare practitioners to enter into an agreement for additional work with their employer with whom they had previously established a full-time employment, for performing activities within their professional competences. A healthcare practitioner may enter into a maximum of three agreements for additional work with other employers beyond regular working hours, for performing activities within its professional competences, for a maximum of one third of the full-time working hours.

As a precondition for the performance of additional work, a healthcare practitioner must obtain prior consent of the director of the HCI or a founder of the private practice, where the healthcare practitioner is employed with full-time working hours.

This consent is provided for a one-year period.

  • Implementation of Recommended Anti-Corruption Measures.

Giving a donation is prohibited, if intended for a body performing supervision or inspection, deciding on the rights, obligations and interests of a donor or in any manner entering into business or other relation with these persons. For example, a commercial entity that wishes to participate in a certain HCI’s public procurement procedure as a bidder, would be prohibited from giving a donation to a person, who is a member of an authority of the respective HCI competent for deciding on the award of a public procurement agreement. Donations are only allowed if the possibility of inappropriate influence is excluded, i.e. if there is no presumption or possibility of such influence.

The Law also regulates conflicts of interest, establishing, as a general rule, that it is prohibited for healthcare practitioners seeking or receiving any benefit for themselves, or a person related to them, which may affect their impartiality or professional performance of their duties.

In this regard, the most boisterous public reaction was caused by the provision of the Law providing for an exception to this rule: that expressing gratitude through gifts of smaller value, i.e. advertising material and samples, which is not expressed in money or securities and which:

  • individual value does not exceed 5% of one average monthly salary without taxes and contributions in RS, and
  • the total value does not exceed the amount of one average monthly salary without taxes and contributions in RS,

shall not be considered as corruption or conflict of interest.

This provision has been criticized since, unlike the anti-corruption legislation, which prescribes the same threshold when it comes to appropriate gifts that an official can receive, however, specifying that the total value of appropriate gifts is related to one calendar year, the Law does not prescribe the period to which the prescribed total value of “gifts of smaller value” relates, which obviously opens the door for potential corruptive activities.

Nevertheless, the Ministry in its announcement regarding public reactions to the so-called “gifts of smaller value” (link) stated that although the Law has been already adopted, “the Ministry of Health remains open and prepared for further improvement of this regulation and making it more functional through the by-laws, based on argumentative suggestions and proposals, in the interest of the citizens of Serbia”.

Therefore, it appears that this gap in the Law was also recognized by the Ministry, due to numerous critics of experts. Accordingly, it seems reasonable to expect this provision of the Law to be changed in the future.

Key takeaway

It is indisputable that the need for adoption of the Law has arisen due to significant changes occurred in the health care system in the period from the adoption of the previous law on healthcare protection in 2005, more than a decade ago.

Therefore, despite some obvious deficiencies, it certainly represents a significant step forward in the improvement and modernization of the health care system in the RS.