EVOLUTION OF RARE DISEASE HEALTH-SYSTEM POLICY IN GREECE - A LEGISLATIVE MAPPING STUDY
Author(s)
Persefoni Kritikou, PhD1, Ioannis John Yfantopoulos, DPhil2.
1Rare Disease Consulting, Athens, Greece, 2Department of Economics, University of Athens, Ekali, Greece.
1Rare Disease Consulting, Athens, Greece, 2Department of Economics, University of Athens, Ekali, Greece.
OBJECTIVES: Comprehensive health-system responses are essential to improve outcomes for people living with rare diseases. Despite substantial legislative activity in Greece, no study has systematically mapped the evolution of rare disease-related legislation or its contribution to health-system development. This study aimed to characterise the Greek rare disease legislative landscape using a structured policy mapping framework.
METHODS: A structured review of the Greek Government Gazette identified legislation relevant to rare disease policy and the broader health-system environment supporting rare disease care published between 1999 and 2026. Eligible legislative instruments were classified using a hierarchical policy mapping framework informed by international rare disease policy priorities across seven health-system domains. Each policy was further characterised by policy function, implementation tier and lifecycle stage to enable longitudinal analysis of health-system evolution.
RESULTS: Overall, 156 legislative instruments were included. Legislative activity remained limited during the early study period but increased substantially from 2017 onwards, with 57.7% (n=90) of all legislation adopted between 2022 and 2026. Legislative activity was concentrated within Care Delivery & Specialised Services (30.1%, n=47) and Access to Medicines & Health Technologies (29.5%, n=46), followed by Diagnosis & Genomic Medicine (13.5%, n=21) and Research & Innovation Ecosystem (12.2%, n=19). Additional legislation addressed Data & Digital Health Infrastructure (7.7%, n=12), Governance & Leadership (5.8%, n=9) and Patient Empowerment & Social Protection (1.3%, n=2). The policy focus progressively shifted from early governance- and access-oriented legislation towards specialised care, genomic medicine, research and digital health infrastructure, reflecting increasing health-system maturity.
CONCLUSIONS: This study provides the first comprehensive mapping of the Greek rare disease legislative landscape over nearly three decades. Findings demonstrate a marked evolution from isolated legislative initiatives towards a coordinated, multi-domain health-system response. The proposed framework offers a reproducible approach for policy monitoring, identifying implementation gaps and supporting comparative policy analyses.
METHODS: A structured review of the Greek Government Gazette identified legislation relevant to rare disease policy and the broader health-system environment supporting rare disease care published between 1999 and 2026. Eligible legislative instruments were classified using a hierarchical policy mapping framework informed by international rare disease policy priorities across seven health-system domains. Each policy was further characterised by policy function, implementation tier and lifecycle stage to enable longitudinal analysis of health-system evolution.
RESULTS: Overall, 156 legislative instruments were included. Legislative activity remained limited during the early study period but increased substantially from 2017 onwards, with 57.7% (n=90) of all legislation adopted between 2022 and 2026. Legislative activity was concentrated within Care Delivery & Specialised Services (30.1%, n=47) and Access to Medicines & Health Technologies (29.5%, n=46), followed by Diagnosis & Genomic Medicine (13.5%, n=21) and Research & Innovation Ecosystem (12.2%, n=19). Additional legislation addressed Data & Digital Health Infrastructure (7.7%, n=12), Governance & Leadership (5.8%, n=9) and Patient Empowerment & Social Protection (1.3%, n=2). The policy focus progressively shifted from early governance- and access-oriented legislation towards specialised care, genomic medicine, research and digital health infrastructure, reflecting increasing health-system maturity.
CONCLUSIONS: This study provides the first comprehensive mapping of the Greek rare disease legislative landscape over nearly three decades. Findings demonstrate a marked evolution from isolated legislative initiatives towards a coordinated, multi-domain health-system response. The proposed framework offers a reproducible approach for policy monitoring, identifying implementation gaps and supporting comparative policy analyses.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR246
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care, Organizational Practices
Topic Subcategory
Insurance Systems & National Health Care, Pricing Policy & Schemes, Public Spending & National Health Expenditures, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Rare & Orphan Diseases