Patient access to cell and gene therapies in Europe: stakeholder perspectives on impeding factors across the medicine lifecycle.

Authors

Christine C van Hattem, Jurriaan Gort, Renske M T Ten Ham, Toine C G Egberts, Lourens T Bloem

Published in

Drug discovery today. Pages 104839. Oct 20, 2026. Epub Oct 20, 2026.

Abstract

Cell (including tissue) and gene therapies (CGTs) have the potential to address unmet medical needs, yet few have successfully navigated the medicine lifecycle toward patient access in Europe because of impeding factors with possibly different stakeholder perspectives. Through a scoping review, we identified 991 document-stakeholder-theme combinations across 30 major themes of impeding factors and seven lifecycle categories. Most frequently reported themes were legislation & regulatory framework and capacity, resources, expertise, followed by uncertainty in regulatory & reimbursement assessments, quality requirements, and collaboration & coordination. Several stakeholders and product types were under-represented. We recommend active multistakeholder collaboration in designing legislation and capacity building to sustain patient access.

PMID:
42901400
Bibliographic data and abstract were imported from PubMed on 21 Oct 2026.

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