💊 German SHI reform: Bundestag adopts final pharmaceutical amendments

 

The German Bundestag has now adopted the final version of the SHI Contribution Rate Stabilisation Act (GKV-BStabG), introducing several important changes for Market Access & Pricing.

 

Key points 📌:

🔹 Additional fixed manufacturer rebate instead of a dynamic rebate: An additional 8.5% rebate will apply, resulting in a total rebate of 15.5% for patented, non-fixed-price medicines.

🔹 Exemptions from the additional manufacturer rebate: Generics, biosimilars, fixed-price products, certain off-patent medicines, reserve antibiotics and products qualifying for the “Germany bonus” remain exempt.

🔹 “Germany bonus” substantially scaled back: The API criterion has been removed; only the ≥5% German clinical trial participant criterion remains for new launches of new substances from 2027 onwards.

🔹 Price-volume regulation substantially revised: Reference periods will be based on years from launch rather than calendar years, with further clarifications on imports, arbitration and transition rules.

🔹 Rebate contracts for patent-protected therapeutic classes: Adopted largely as proposed in the cabinet draft.

🔹 Price moratorium remains company-based: The proposed shift to an active-substance-based approach has been reversed.

🔹 AMNOG price guardrails and the combination discount: Both have been formally abolished.

 

Overall, the final law increases planning certainty in some areas, while maintaining substantial pricing pressure on patented medicines and further increasing the complexity of the German reimbursement framework. 👥

 

🗣️💬 We are currently discussing the practical implications with several companies and would be happy to exchange your views on portfolio-specific impacts and strategic considerations.