Placenta Donation and Regenerative Medicine Framework: A Policy Model for Montenegro Aligned with EU Tissue and Cells Directives

This policy paper proposes a comprehensive framework for the integration of placenta donation into the healthcare system of Montenegro, aligned with European Union directives on human tissues and cells. Placenta, a biologically valuable tissue, is currently treated as medical waste despite its significant potential in regenerative medicine, tissue engineering, and scientific research. The document outlines: – legal and regulatory pathways – ethical principles and donor protection – operational protocols for collection and processing – a pilot implementation model – opportunities for cross-border cooperation with EU-accredited institutions The framework builds upon existing legislative developments in Montenegro, including provisions for the establishment of a national reproductive material and tissue bank within the Clinical Center of Montenegro. By integrating placenta donation into existing healthcare structures, this model provides a scalable and cost-effective approach to healthcare innovation, while ensuring full compliance with bioethical standards and European regulations. The paper is intended for policymakers, healthcare institutions, and international stakeholders engaged in the development of regenerative medicine and healthcare systems.