The current draft bill on statutory health insurance contribution rate stabilization (BStabG) sets out the health policy objective of tighter expenditure control — with direct implications for pricing, market access, and reimbursement in the German market.
An overview of the key changes for innovative products:
The central instrument for cost-control in the pharmaceutical market will be the dynamic manufacturer discount limiting the drug expenditure to the income of the statutory health insurances. The implicit drug budget will have impact on the pricing for new innovative drugs and will create interdependencies between prices for new drugs and patent-protected drugs that are already in the market.
The dynamic manufacturer rebate is a regulatory misstep The planned introduction of a dynamic manufacturer rebate for patent-protected medicines (§ 130a para. 1b SGB V) as part of the BStabG (statutory health insurance contribution rate stabilization bill) raises significant regulatory questions — p…
The price-volume regulation shall no longer be subject to arbitration. The default mechanism kicks in if no agreement between the pharmaceutical company and the statutory health insurances is reached and adjusts the reimbursement amount annually (starting in the third calendar year after launch) usi…
Pediatric drug shortages: has the situation really improved? In recent years, Germany has faced shortages of essential medicines for children, including antipyretics and antibiotics. To encourage manufacturers to increase production and supply, the GKV-SV (GKV-Spitzenverband, German SHI association)…
Since the beginning of 2025, member states of the European Economic Area (EEA) have been working together on joint clinical assessments (JCA) of new medicines. Recently, the first 9 JCAs were announced, assessing 2 ATMPs with Orphan drug status and 7 oncologics. Germany, France, and Ireland are curr…
