CHALLENGES IN MANAGING THE REPRODUCTIVE CELL DONATION PROGRAM PROCESS IN SERBIA

Biljana Djordjević; Lela Šurlan; Ana Mitrović Jovanović; Dejan Petrović

doi:10.5937/zdravzast54-61363

Biljana Djordjević Special Gynaecology Clinic “SGB Teofanovic”, Belgrade, Republic of Serbia
Lela Šurlan University Clinical Center of Serbia - Bank of RCTE, Belgrade, Serbia; Obstetrics and Gynecology Clinic “Narodni Front”, Belgrade, Serbia
Ana Mitrović Jovanović Special Gynaecology Clinic “SGB Teofanovic”, Belgrade, Republic of Serbia; Obstetrics and Gynecology Clinic “Narodni Front”, Belgrade, Serbia
Dejan Petrović University of Belgrade, Faculty of Organizational Sciences, Belgrade, Serbia

DOI: https://doi.org/10.5937/zdravzast54-61363

Keywords: Gamete donation, reproductive medicine, RACI matrix, SWOT analysis, institutional coordination

Abstract

Introduction/Aim: This study examines the governance challenges in Serbia's egg and sperm donation system. The necessity of donors importing donated reproductive cells requires coordination among clinics, regulatory agencies, and international tissue banks. The main objective is to analyse the roles, responsibilities of key institutions and stakeholders in the donation program, exploring opportunities for system improvement through clinical alignment and analysis of implementation in Fertility clinics.

Methods: A descriptive statistical method was applied to the data collected using a questionnaire sent to IVF clinics, utilising the Resposinble, Accoutable, Consulted and Informed (RACI) matrix to define institutional roles, and conducting a Strengths, Weaknesses, Opportunities and Threats (SWOT) analysis based on the RACI matrix results.

Results: RACI analysis revealed that the Ministry of Health bears the highest number of information responsibilities, confirming its leading, regulatory, and supervisory role. Based on the questionnaire, Clinical Embryologists handle most documentation tasks, including packaging and shipping (47.1%) and communication with tissue banks (58.8%). Most respondents (41.2%) reported that documentation errors rarely occur, while non-compliances from foreign banks were very uncommon (70.6%), and the Ministry's institutional support was viewed as limited.

Conclusion: The results highlight a system with unclear and limited strategic communication, utilising the RACI matrix, which proved to be useful in clarifying institutional roles. The SWOT analysis emphasised both strengths (professional capacity) and threats, highlighting that excessive centralisation of roles can overload an institution and slow down processes. Future research should focus on quantitative analyses of clinical outcomes related to the origin and quality of donated material, as well as comparative evaluations of communication between institutions, banks and regulatory bodies.

References

Guerra Neto CLB, Valentim RAM, Araujo Filho I, Hekis HR, Cabral ELS, Castro WRS, et al. Minnesota innovation survey at the Brazilian Hospital services company. Eur J Sci Res. 2018;150(3):322-33.

Gottweis H. Biobanks for Europe: A challenge for governance: Report of the expert group on dealing with ethical and regulatory challenges of international Biobank Research. Brussels: European Commission (EUR-OP); 2012.

Srbija. Zakon o biomedicinski potpomognutoj oplodnji. Službeni glasnik RS. 2017; br. 40:1-13.

Srbija. Pravilnik o uslovima za obavljanje postupaka biomedicinski potpomognute oplodnje, sadržaju medicinske dokumentacije, evidencijama i izveštavanju. Službeni glasnik RS. 2019; br. 27.

Srbija. Pravilnik o uslovima koje moraju ispunjavati banke reproduktivnih tkiva i ćelija i načinu čuvanja i obeležavanja reproduktivnih tkiva i ćelija. Službeni glasnik RS. 2018; br. 92.

European Parliament and Council. Directive 2004/23/EC of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Off J Eur Union. 2004;L102:48-58.

European Commission. Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. Off J Eur Union. 2006;L38:40-52.

Rinehart L. Storage, transport, and disposition of gametes and embryos: legal issues and practical considerations. Fertil Steril. 2021;115(2):274-81. doi: 10.1016/j.fertnstert.2020.12.015.

European Directorate for the Quality of Medicines & HealthCare (EDQM). Guide to the quality and safety of tissues and cells for human application. 4th ed. Strasbourg: Council of Europe; 2019. Available from: https://www.edqm.eu/ [Accessed 26th Jan 2026].

Agency for Healthcare Research and Quality (AHRQ). Fall Prevention Program Implementation Guide: Appendix A. RACI chart [Internet]. Rockville (MD): AHRQ; 2017. Available from: https://www.ahrq.gov [Accessed 26th Jan 2026].

Masefield SC, Msosa A, Grugel J. Challenges to effective governance in a low income healthcare system: a qualitative study of stakeholder perceptions in Malawi. BMC Health Serv Res. 2020;20(1):1142. doi: 10.1186/s12913-020-05981-z.

Jalilvand MA, Raeisi AR, Shaarbafchizadeh N. Hospital governance accountability structure: a scoping review. BMC Health Serv Res. 2024;24(1):47. doi: 10.1186/s12913-023-10515-3.

Antoniou S, Di Nisio V, Messini F, Daponte A, Rajender S, Anifandis G. A comprehensive review and update on human fertility cryopreservation methods and tools. Front Vet Sci. 2023;10:1151254. doi: 10.3389/fvets.2023.1151254.

Estudillo E, Jiménez A, Bustamante-Nieves PE, Palacios-Reyes C, Velasco I, López-Ornelas A. Cryopreservation of gametes and embryos and their molecular changes. Int J Mol Sci. 2021;22(19):10864. doi: 10.3390/ijms221910864.

Rossignoli L. Europe moves towards complete statutory regulation of assisted reproduction but large variations still exist in how the legislation is applied [Internet]. Focus on Reproduction; 2023. Available from: https://www.focusonreproduction.eu/ [Accessed 26th Jan 2026].

Martani A, Neeser N, Vulliemoz N, Pennings G. Challenges for the legislation enabling egg donation in Switzerland. Med Law Int. 2024;24(3):192-216. doi: 10.1177/09685332241269583.

Đorđević B, Janičić R, Matejić B. Strengths and weaknesses of the reproductive bioeconomy market: insights from the literature review. Srp med čas Lek komore. 2025;6(2):178-191.