Objectives: The aim of this study was to describe and analyze the introduction of health technology (HTA) in Romania.
Methods: Based on a review of the literature and legislative documents and personal experiences and observations, the authors describe, evaluate, and explain the background and evolution of the HTA system.
Results: Initiatives to introduce HTA in Romania date from the early 1990s, but real steps were taken only in 2012 when the European Union Directive 2011/24/ on the application of patients’ rights in cross-border health care had to be passed into Romanian law.
The main developments consist of: the establishment of a national competent authority, the development of a methodology for the rapid assessment of drugs, setting HTA as the main tool for compiling the list of medicines to be covered by the NHIF, and capacity building initiatives. One early result of HTA implementation was an updated list of reimbursed drugs, allowing Romanian patients access to new, innovative medicines.
Conclusions: In Romania, HTA become an issue for all stakeholders: decision makers are interested in cost-containment, patients in obtaining the best care, and producers in receiving acceptable reimbursement remains on the health policy agenda. Further steps are envisaged, especially for international collaboration, which is considered an important factor for HTA development in Romania.