Constructing a single market for pharmaceuticals in the EU: what’s the price?

Sep 29, 2026

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The European Union is overhauling pharmaceutical regulations to mature a single market for medicines within a “European Health Union.” The article analyzes how regulatory design and market construction interact, showing reforms pursue equitable access to innovation while linking access to regulatory exclusivities that restrict price competition. It also limits pricing transparency, with prices largely opaque and set nationally rather than formed through EU-level market exchange and competition.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages15

Reading Time38 min

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Abstract

Pharmaceutical reform and market construction in the EU

Interactions between regulations and markets

Europe PMC unders uthManuscripts Europe M eC und Author Manuscripts | Europe PMC Funders Group
Author Manuscript
Health Econ Policy Law. Author manuscript; available in PMC 2026 January 07. | | --- | | Published in final edited form as:
Health Econ Policy Law. 2026 April 01; 21(2): 168–180. doi:10.1017/S1744133125100236 .
Constructing a single market for pharmaceuticals in the EU: what’s the price?
Tineke Kleinhout-Vliek 1 , Susi Geiger1 , Rob Hagendijk2 , Eva Hilberg3 , Paul Martin3 , Katrina Perehudoff4 , Sarah Wadmann5 , Jakob Wested6
1College of Business, University College Dublin, Belfield, Dublin 4,, Ireland.
2 Faculty of Social and Behavioural Sciences, University of Amsterdam, Amsterdam, the Netherlands.
3 Department of Sociological Studies, University of Sheffield, Sheffield, UK.
4Law Centre for Health and Life, University of Amsterdam, Amsterdam, the Netherlands.
5VIVE, The Danish Center for Social Science Research, Copenhagen K, Denmark.
6 Faculty of Law, University of Copenhagen, Copenhagen S, Denmark.
Abstract
The European Union (EU) is currently overhauling its pharmaceutical regulations, seeking to mature a single market for medicines as part of a ‘European Health Union’. We reflect on the interactions between regulations and markets in these reforms and investigate what this single market for medicines may mean in practice. We note how the proposed reforms aim to ensure equitable access to innovative treatments, yet at the same time, tie this access directly to regulatory exclusivities, limiting price competition. The reforms also do not seek full pricing transparency: prices will remain largely opaque and be set at the national levels rather than created through market exchange and open competition at the EU level. The envisioned single market for medicines thus remains a market that operates without direct reference to price − a situation not addressed head-on by the proposed reforms.
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence ([https://creativecommons.org/](https://creativecommons.org/)[ ](https://creativecommons.org/)[licenses/by/4.0/](licenses/by/4.0/)), which permits unrestricted re-use, distribution and reproduction, provided the original article is properly cited. Correspondence to: Tineke Kleinhout-Vliek.
Corresponding author: Tineke Kleinhout-Vliek; tineke.kleinhout-vliek@ucd.ie .
Competing interests. Authors 1 and 2 are members of the Public Pharma for Europe coalition. Author 6 has received two honorariums from the WHO European Regional Office in the last two years. The other authors declare no competing interests.
Use, distribution, and reproduction. This is an open access work distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Financial support.
• Danmarks Frie Forskningsfond [Grant Number: 1055-00010B] .
• European Research Council (ERC) under the European Union’s Horizon 2020 research and innovation programme [Grant Number: 771217]
• Nederlandse Organisatie voor Wetenschappelijk Onderzoek [Grant type: Veni]
• Wellcome Trust [Grant Number: 219875]
No funder had any role in the design, execution, analysis and interpretation of data, or writing of the study | Europe PMC unders uthManuscripts Europe M eC und Author Manuscripts Kleinhout-Vliek et al. Page 2 Keywords European Union; pharmaceuticals; Health Technology Assessment; single market; pricing and reimbursement Pharmaceutical reform and market construction in the European Union ‘Today we add another central pillar to our European Health Union. We are putting forward proposals to ensure that medicines reach patients everywhere in Europe, in a timely and equitable fashion. It is a reform which ensures that Europe remains attractive for business, and our pharmaceuti

FAQs

What is the EU aiming to achieve with its pharmaceutical regulatory reforms?

The EU aims to mature a single market for medicines within a “European Health Union,” improving timely and equitable access across Europe.

How do regulatory exclusivities affect price competition?

The reforms tie access to innovative treatments to regulatory exclusivities, which limits price competition despite goals of equitable access.

Why does the article argue the proposed single market lacks direct price reference?

The reforms do not seek full pricing transparency; prices remain largely opaque and are set at national levels rather than through EU-level open competition and market exchange.

Sep 29, 2026

Upload by dawugda