Legal Aspects of Stem Cell Treatment in Healthcare Facilities in Serbia
In recent years, the application of stem cell therapies has become a significant part of the development of modern medicine. These therapies offer promising results in treating various diseases and injuries, opening new avenues in medical science. In Serbia, interest in stem cell treatments is on the rise, bringing with it numerous legal questions and challenges. In this article, we will focus on the legal aspects of implementing stem cell treatments in healthcare facilities, with a specific emphasis on regulations related to autologous cell products from adipose tissue, bone marrow, and the Platelet Rich Plasma (PRP) method.
What questions arise in practice?
The main question that arises is: Can healthcare facilities in Serbia perform stem cell treatments, and under what conditions? To answer this question, we will examine relevant legal regulations and provisions pertaining to this field. We will consider whether a special permit or consent from healthcare inspection is required for carrying out such treatments and, if so, what the procedure is for obtaining it.
What is the goal of this text?
The aim of this article is to provide clear information and legal guidance to professionals and the general public to ensure that stem cell treatments are conducted in accordance with the applicable legislation in Serbia. Based on a comprehensive analysis of the legal framework, we will provide an opinion on the legality and regulations surrounding stem cell treatments, with a special focus on autologous cell products from adipose tissue and bone marrow, as well as the PRP method.
Understanding the Law on Healthcare in Serbia: Key Provisions
According to the provisions of the Law on Healthcare (“Official Gazette of the RS,” No. 25/19, 92/23-authentic interpretation), healthcare activities are activities through which healthcare is provided to citizens through the healthcare system. Measures and activities related to healthcare must be based on scientific evidence, be safe, effective, and in accordance with professional standards, adopted good practice guidelines, treatment protocols, and principles of professional ethics.
Application of Scientifically Proven Healthcare Technologies: Legal Requirements
The law also stipulates that healthcare facilities and private practices are obliged to use scientifically proven, verified, and safe healthcare technologies in the prevention, diagnosis, treatment, healthcare, and rehabilitation of the sick and injured.
Definition and Significance of Healthcare Technologies in Serbia
Healthcare technologies, as defined by the law, encompass all healthcare methods and procedures that can be used to improve people’s health in terms of prevention, diagnosis, treatment, healthcare, and rehabilitation of the sick and injured. These technologies include safe, high-quality, and effective medicines and medical devices, medical software, medical procedures, as well as the conditions for their use.
What is a new healthcare technology?
A new healthcare technology is defined as a healthcare technology that is being introduced for the first time for use in the Republic of Serbia or at a certain level of healthcare. Detailed conditions, the process of assessing healthcare technologies, and providing opinions, as well as other matters related to the assessment of healthcare technologies, are regulated by the Minister, upon the proposal of the Public Health Institute established for the territory of the Republic of Serbia.
According to the Law, the assessment of healthcare technologies involves comparing new technologies with the technology already in use or considered the best practice (“gold standard”) based on clinical effectiveness and safety, economic analysis, ethical, legal, social, and organizational consequences and effects. Detailed conditions, the process of assessing healthcare technologies and providing opinions, as well as other matters related to the assessment of healthcare technologies, are regulated by the Rulebook on the Detailed Conditions and Methods for Assessing Healthcare Technologies (“Official Gazette of the RS,” No. 97/20).
How is the assessment of healthcare technologies carried out?
The Rulebook stipulates, among other things:
- That a healthcare institution, another legal entity authorized by a special law to perform healthcare activities, or a private practice may apply a new healthcare technology if they have adequately trained personnel and the necessary space, equipment, drugs, and medical devices, in accordance with the decision issued by the Minister of Health for the use of the new healthcare technology.
- That medical procedures in day surgery and medical procedures in “anti-aging” medicine performed in healthcare facilities and private practice registered in surgical branches of medicine or dental medicine, which are not registered for inpatient treatment, are carried out in healthcare facilities and private practice as procedures of new healthcare technologies, as listed in Annex 1 and Annex 2 of the Rulebook.
- That medical procedures in day surgery and medical procedures in “anti-aging” medicine that are not listed in Annex 1 and Annex 2 are introduced in the prescribed manner, by submitting a request that includes administrative information as well as a health-economic part with:
- A description and purpose of using the new medical procedure: preventive, diagnostic, therapeutic, rehabilitative.
- A description of the health problem for which the new medical procedure is intended, along with a description of the relevant patient population, expected clinical effectiveness (efficacy, safety, and quality of life), and clinical effects of applying the new medical procedure.
- Conditions for the application of the new medical procedure, with a precise description of the necessary specializations, knowledge, or skills required for the application of the new medical procedure.
- Information on the safety of the new medical procedure and the level of risk during its application in terms of adverse effects on the lives and health of patients or the population.
- An analysis of available scientific literature on the clinical effectiveness and safety of the new medical procedure, as well as data on assessments of the new medical procedure conducted in other countries, if available.
- An analysis of the costs or economic analysis of the application of the new medical procedure, including the costs of the described conditions and the use of other technologies for the application of the new medical procedure.
- Justification for introducing the new medical procedure.
- Expected benefits for health and health policy, expected impact on improving healthcare, and expected financial effects.
- Proposed level of healthcare for which the application of the new medical procedure is intended.
- The use of the new medical procedure in other countries.
Regarding the mentioned methods, it should be noted that the PRP technique in aesthetic medicine is listed as a procedure in the field of aesthetic “anti-aging” medicine (Regenerative medicine – used for removing signs of aging), while procedures like Lipofilling (for the face, specific regions, hands) are procedures that can be performed in day surgery in the field of Plastic, Reconstructive, and Aesthetic Surgery (Regional lymph-node dissection).
Therefore, in addition to obtaining a permit for the commencement of healthcare facility operations, it is necessary to apply to the Ministry of Health to obtain a permit for the use of new healthcare technology.
In conclusion, the examination of the legal framework in Serbia for the introduction and application of new healthcare technologies demonstrates the serious approach the state takes in this area. The Law on Healthcare, together with the Rulebook on the Assessment of Healthcare Technologies, provides the foundation to ensure that new medical methods and procedures are not only scientifically confirmed and safe but also adhere to high standards of quality and efficiency. This is crucial not only for the protection of patients and ensuring the best possible treatment but also for maintaining the integrity of the healthcare system in Serbia.
Considering the dynamic development of medical science and technology, these laws and regulations play a key role in ensuring that innovations in healthcare in Serbia are applied responsibly and ethically. Healthcare institutions and professionals are obligated to follow these legal guidelines to ensure best practices in their respective fields. For patients and healthcare workers in Serbia, this means access to therapies that not only bring new hope in treatment but are also supported by rigorous legal and regulatory processes that guarantee their safety and efficacy.