Can Healthcare Institutions in Serbia Perform Stem Cell Treatments?
Stem cell treatments hold significant potential in the field of regenerative medicine. However, in Serbia, performing such treatments involves navigating strict legal and regulatory frameworks. If you’re a healthcare provider or simply curious about the topic, here’s what you need to know about the conditions under which healthcare institutions in Serbia can perform stem cell treatments.
Key Questions Surrounding Stem Cell Treatments in Serbia
At AK STATT, clients frequently ask us about the regulations governing stem cell treatments in Serbian healthcare institutions. Commonly asked questions include:
- Can healthcare institutions in Serbia perform stem cell treatments, and in what form of institution?
- Is an additional permit required beyond the standard health inspection consent?
Specifically, the treatments in question include:
- Autologous cell products from adipose tissue
- Autologous cell products from bone marrow
- PRP (Platelet-Rich Plasma) method
To address these questions, we analyze the relevant laws and regulations.
Legal Framework for Stem Cell Treatments in Serbia
General Healthcare Regulations
The Law on Healthcare (Official Gazette of RS, No. 25/19, 92/23 – authentic interpretation) clearly outlines the requirements for performing healthcare services in Serbia. It emphasizes that all healthcare activities must:
- Be scientifically proven and based on evidence.
- Follow good practice guidelines and professional ethics.
- Utilize safe and effective healthcare technologies for the diagnosis, treatment, and rehabilitation of patients.
Defining Healthcare Technologies
Healthcare technologies refer to methods and procedures that enhance human health, including:
- Medicines and medical devices.
- Medical procedures and software.
- Conditions necessary for their safe application.
Importantly, new healthcare technologies are defined as methods or procedures introduced for the first time in Serbia or within a specific healthcare setting.
How to Introduce New Healthcare Technologies in Serbia
Before healthcare institutions can use new healthcare technologies, they must follow a thorough approval process. This process includes comparing the proposed technology with existing ones, often referred to as the “gold standard.”
The evaluation process involves:
- Assessing clinical effectiveness.
- Ensuring safety compliance.
- Conducting economic impact analyses.
- Considering other relevant factors.
Regulated by the Rulebook on Closer Conditions and Manner of Performing Healthcare Technology Assessment (Official Gazette of RS, No. 97/20), the approval process mandates that healthcare institutions:
- Employ trained staff.
- Have appropriate facilities, equipment, and devices.
- Obtain approval from the Ministry of Health.
Without meeting these criteria, healthcare institutions cannot introduce new technologies legally.
Specific Requirements for Stem Cell Treatments
1. Autologous Cell Products from Adipose Tissue
- These procedures qualify as new healthcare technologies.
- Institutions must secure additional permits from the Ministry of Health.
2. Autologous Cell Products from Bone Marrow
- Like adipose tissue treatments, these also require classification as new technologies.
- Approval from the Ministry of Health is essential.
3. PRP Method
- This method is widely recognized in aesthetic and anti-aging medicine.
- It can be performed in institutions specializing in surgical or dental medicine.
- Nonetheless, if classified as a new technology, Ministry approval is still required.
AK STATT’s Position
Based on the legal framework, healthcare institutions in Serbia can perform stem cell treatments if they meet the following conditions:
- Qualified Personnel and Facilities: Institutions must employ trained professionals and ensure adequate infrastructure, including necessary medicines and medical devices.
- Ministry of Health Approval: Additional permits are mandatory for procedures classified as new healthcare technologies.
- Compliance with Safety Standards: All treatments must adhere to scientifically validated methods and safety guidelines.
In summary, obtaining health inspection consent alone is insufficient. Additional approvals from the Ministry of Health are critical for legal compliance and ensuring patient safety.