Romania's Pioneering Law: Establishing the Right to Personalized Medicine.

ABSTRACT

This analysis and commentary discuss Romania's landmark law, the first globally, acknowledging the right of citizens and patients to personalized medicine. Initiated following the EU Council's 2015 policy on personalized medicine, the law is a result of intersectoral collaborative efforts led by the Centre for Innovation in Medicine in Romania using a quadruple (later evolved to penta) helix model involving academia, public, private, and civil society sectors. Promulgated on May 24, 2023, the law legally entitles patients to personalized health care and in ways informed by individual genetic and phenotypic consideration. The law mandates informed consent for medical interventions and ensures data protection in accordance with the General Data Protection Regulation. We suggest that this pioneering legislation paves the way for integrating personalized medicine into Romania's health care system, shaping clinical practice, research, and health policy. In all, it marks a significant step in redefining health care delivery, emphasizing individualized treatment and the political determinants of personalized medicine, and setting a precedent for future health care innovations worldwide.