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


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.

SUBMITTER: Kleinhout-Vliek T 

PROVIDER: S-EPMC7618563 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature

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

Kleinhout-Vliek Tineke T   Geiger Susi S   Hagendijk Rob R   Hilberg Eva E   Martin Paul P   Perehudoff Katrina K   Wadmann Sarah S   Wested Jakob J  

Health economics, policy, and law 20251027 2


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 pr  ...[more]

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