Caveated Confidential Pricing Arrives In Germany But May Not Prove Attractive To Companies

A new act in Germany does not go far enough to address the deeply unpopular “guardrail” link between Amnog benefit assessment ratings and price negotiations, which can deter companies from launching.

Guardrail
Further action is required to mitigate guardrail measure that curbs drug pricing pricing • Source: Shutterstock

New provisions to introduce confidential drug pricing in Germany are a step in the right direction, but the conditions attached mean that many companies will not qualify while others may not want to, said Alexander Natz, Secretary General of EUCOPE, the organization that represents small and medium-sized pharma and biotech companies in Europe.

The Bundestag, Germany’s federal parliament, passed the wide-ranging Medical Research Act on 4 July. The aim of the act is to make Germany a more desirable location for conducting clinical research by simplifying the authorization and conduct of clinical studies, paving the way for specialized ethics committees and setting out the basis for binding standard contractual clauses. (Also see "Germany Promises Harmonized ATMP Rules & More Flexibility For Decentralized Trials" - Pink Sheet, 22 March, 2024

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