25. Apr 2019

In Belgrade, on 3 April 2019, the National Assembly of the Republic of Serbia adopted the Law on Health Care (“Official Gazette of the Republic of Serbia,no. 25/2019) (hereinafter: The Law), which entered into force on 11 April 2019, thereafter the previous Law on Health Care ceased to apply (“Official Gazette of the Republic of Serbia,no.107/2005, 72/2009 – other law, 88/2010, 99/2010, 57/2011, 119/2012, 45/2013 – other law, 93/2014, 96/2015, 106/2015, 113/2017 – other law and 105/2017 – other law). All provisions of the Law entered into force on 11 April 2019, except for the provisions of Article 115, paragraph 1, item 2, which shall be applied by the expiration of 36 months from the date of entry into force of this Law, that is from the 11 April 2022, which refers to the obligation of the director of the health institution to have completed accredited training in the field of health management.

This Law regulates the health care system, issues that are important for the organization of health care and its implementation, social care for the health of the population, general interest in health care and supervision of its implementation.

The priority principle of the Law is respect for human rights and the values and rights of the child in health care, which implies providing the highest possible standard of human rights and values in the provision of health care, and which contains in itself a number of principles that provide health care and which are also guaranteed by the Constitution of the Republic of Serbia (“Official Gazette no. 98/2006); the principle of justice is extended to categories of non-discrimination; the principle of comprehensive health protection includes health care; the principle of accessibility explicitly includes the disabled persons.

The law introduces the right to health care of foreign nationals and stateless persons who are permanently residents or temporary residents in the Republic of Serbia. The terms and coverage of health care, participants, activity and health care system are also hereby specified.

One of the most important novelties is that the Register of Health Institutions will be managed by the Business Registers Agency (hereinafter: BRA), instead of commercial courts, which previously did that. Also, the BRA will, in addition to the Register of Health Institutions, keep a Unique Record of Health Care Entities, which will be established within 18 months from the date of entry into force of this Law.
Health institutions are obliged to submit an application for harmonizing of registration in the register of health institutions conducted by the BRA within three months from the date of data transfer from the Commercial Courts to the BRA.
The Law also regulates the conditions and obligations for the performance of the healthcare activity of private practice, termination of work, restrictions and conditions for engagement of an external healthcare professional of another specialty. Private practice is registered at the BRA for the established business activity. Temporary cessation of private practice is up to 5 years (for a pharmacy of up to 30 days). Upon termination of work up to 30 days, the notice shall be posted at the place of its performance, and in case of termination of work longer than 30 days (and its completion), the Ministry shall be informed, as well as BRA and the Medical chamber. In addition to these, the Law envisages the adoption of the Development Strategy, the Network Plan, the relevant bylaws, implementing regulations and a Guide to good pharmacy practice.

The Law prescribes the obligation of health institutions / private practices to inform the BRA about the schedule of work and working hours. Thereafter, a strike has been banned in institutions providing emergency medical care and dealing with emergency conditions, and for other institutions it stipulates the obligation to provide the minimum of service. Also, on-call duty is considered overtime and the conditions and duration of its performance are envisaged under this Law. In this regard, it is no longer the case that on-call duty time involves preparedness and work on the call, since the Law does not treat the concept of preparedness as overtime work. Additional work is limited to a maximum of three employment agreements on additional employment in the total duration of up to one-third of full-time work.

The healthcare activity is carried out at the primary, secondary and tertiary levels and the related obligations are prescribed, with reference to healthcare activities and institutions by level.

The law also prescribes the bodies of the health institution that are publicly owned, such as: the director, the board of directors and the supervisory board. Also, the conditions for their work are envisaged, including the prohibition of conflict of interest, appointment, deadlines and dismissal, a more detailed description of the jobs, qualifications and circumstances concerning their mandate. The novelty in this part of the Law concerns the prescribing of professional qualifications for the members of the administrative and supervisory board.

In addition to these bodies, health institutions are obliged to organize the following professional bodies: expert council, expert collegium, ethics committee, commission for improving the quality of health care, for which the Law prescribes competencies, composition, qualifications and other circumstances, with limitations. Expert bodies at the Republic level are: Health Council of Serbia, Ethics Committee of Serbia, Republic Expert Commission.

Supervision over the implementation of the Law and other regulations in the field is performed as an inspection supervision through a health inspector or a pharmaceutical inspector, depending on the supervised institution.

Penal provisions prescribe violations and penalties for these violations, for: responsible persons, legal entities, entrepreneurs and health workers.