From Vision to Reality: The EU’s Pharmaceutical Reforms and the Path to Improved Access

Caitlin Main (), Cathrin Schäfer and Panos Kanavos
Additional contact information
Caitlin Main: LSE Health, London School of Economics and Political Science
Cathrin Schäfer: BeiGene
Panos Kanavos: LSE Health, London School of Economics and Political Science

PharmacoEconomics - Open, 2025, vol. 9, issue 3, No 1, 339 pages

Abstract: Abstract Disparities in access to oncology medicines in European Union (EU) member states can impact patient outcomes profoundly, with availability and timely access varying significantly across and within member states. This paper discusses the intersection of the new European Health Technology Assessment Regulation (HTAR), the provisions of the proposed pharmaceutical legislation and their potential impacts on access to oncology medicines across EU member states. The HTAR, seeking to standardise the clinical evaluation of new medicines, has the potential to streamline the evaluation process but also risks oversimplifying diverse national healthcare needs. While the HTAR may accelerate access in countries with less-developed health technology assessment systems, it could potentially conflict with established practices in countries with advanced assessment systems, resulting in both joint and national clinical evaluations becoming necessary. The proposed pharmaceutical legislation reform, in both initial and updated forms, aims to incentivise an EU-wide launch of new medicines that challenges the feasibility for manufacturers, particularly in the context of diverse and complex national pricing and reimbursement systems. Both initiatives mark a significant shift towards more collaborative European healthcare policy yet faces the potential of unintended consequences owing to an apparent lack of pragmatism, such as delays in access because of increased administrative burdens and possible deterrents for innovation in Europe. The paper underscores the need for policy adaptation and multi-stakeholder collaboration to ensure the legislative changes achieve equitable and timely access to oncology treatments across the EU.

Date: 2025
References: View references in EconPapers View complete reference list from CitEc
Citations:

Downloads: (external link)
http://link.springer.com/10.1007/s41669-024-00556-w Abstract (text/html)

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:pharmo:v:9:y:2025:i:3:d:10.1007_s41669-024-00556-w

Ordering information: This journal article can be ordered from
http://www.springer.com/adis/journal/41669

DOI: 10.1007/s41669-024-00556-w

Access Statistics for this article

PharmacoEconomics - Open is currently edited by Timothy Wrightson and Christopher Carswell

More articles in PharmacoEconomics - Open from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().