ReviewHealthcare (Basel, Switzerland)2026
From Legislative Harmonization to Real-World Access: A Scoping Review of Pharmaceutical Regulation and Access to Medicines in Romania.
Review in Healthcare (Basel, Switzerland), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- The Post-Authorisation Maze: Mapping of European Pharmaceutical Market Access Pathways in the Early JCA Era.Journal of market access & health policy · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThis 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
methodsData 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).
resultsFifty 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).
conclusionsLegislative 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.