# From Legislative Harmonization to Real-World Access: A Scoping Review of Pharmaceutical Regulation and Access to Medicines in Romania

## TL;DR

Romania faces significant delays and limited access to medicines despite aligning with EU pharmaceutical laws, due to issues like high co-payments and pricing policies.

## Contribution

This scoping review maps how EU pharmaceutical legislation translates into real-world access outcomes in Romania, identifying systemic barriers and evidence gaps.

## Key findings

- Romania has mean delays exceeding 800 days for centrally authorized medicines, compared to 578 days at the EU level.
- Innovative therapies, especially in oncology, are available in Romania at about 20%, versus 50% in the EU average.
- Medicine shortages are linked to low-price regulation and parallel export dynamics.

## Abstract

What are the main findings?
Despite extensive alignment with European pharmaceutical legislation, Romania continues to experience severe delays, shortages, and limited reimbursement of innovative medicines;Restricted access to medicines is driven by systemic factors, including pricing policies, reimbursement delays, high co-payments, and parallel export.

Despite extensive alignment with European pharmaceutical legislation, Romania continues to experience severe delays, shortages, and limited reimbursement of innovative medicines;

Restricted access to medicines is driven by systemic factors, including pricing policies, reimbursement delays, high co-payments, and parallel export.

What are the implications of the main findings?
Limited access to medicines may increase avoidable hospitalizations and healthcare utilization, particularly among aging and vulnerable populations;Policy reforms targeting reimbursement timelines, pricing strategies, and patient co-payments are essential to improve health system efficiency and equity.

Limited access to medicines may increase avoidable hospitalizations and healthcare utilization, particularly among aging and vulnerable populations;

Policy reforms targeting reimbursement timelines, pricing strategies, and patient co-payments are essential to improve health system efficiency and equity.

Objectives: This scoping review aimed to map European and Romanian pharmaceutical legislation and policy-related evidence and to examine how legislative harmonization translates into access outcomes in Romania. Eligibility criteria: Legislative documents, institutional reports, market analyses, and peer-reviewed studies addressing pharmaceutical regulation, pricing, reimbursement, and access to medicines (2000–2024). Sources of evidence: EUR-Lex, the Romanian Legislative Portal, PubMed, Scopus, Google Scholar, and institutional sources (European Commission, OECD, WHO, EFPIA, NAMMDR, CNAS). Charting methods: Data were extracted using a standardized charting form and synthesized narratively across thematic domains (regulatory harmonization, pricing and reimbursement, medicine shortages, comparative EU indicators, and health system implications). Results: Fifty sources were included. The mapped evidence consistently identified three dominant patterns: (1) prolonged time-to-availability for centrally authorized medicines, with mean delays exceeding 800 days in Romania compared with approximately 578 days at EU level; (2) limited availability of innovative therapies, particularly in oncology (approximately 20% availability in Romania versus around 50% EU average); and (3) recurrent medicine shortages associated with low-price regulation and parallel export dynamics. Evidence gaps include limited Romania-specific empirical evaluation of the causal effects of individual policy levers (e.g., external reference pricing, reimbursement timelines, clawback mechanisms). Conclusions: Legislative harmonization alone has not ensured equitable or timely access to medicines in Romania. The evidence suggests that national pricing, reimbursement, and supply governance mechanisms mediate the relationship between EU regulation and real-world patient access, highlighting the need for targeted policy reforms and further empirical investigation.