Changes to the German pricing system for innovative drugs are now in effect due to the Medical Research Act (Medizinforschungsgesetz, MFG). As of January 1st, 2025, European reference prices will no longer be included in the price negotiations according to § 130b SGB V following AMNOG benefit assessment of innovative drugs. It will also be more difficult for other countries to reference the German price, as the reimbursement amount may be confidential in the future.
Figure 1: Number of reference prices used by each country
In the past, the European reference prices have been an important factor in price negotiations with statutory health insurances (SHI) and there was a legal obligation to take them into account (former § 130b (9) sentence 3 SGB V). Both the pharmaceutical companies as well as the SHI representatives were able to include the prices of the innovative drug in question in a certain number of other European countries in their strategies for the negotiation of the reimbursement amount. With the implementation of the MFG, the European Reference prices are being removed from the price negotiations. This is all the more remarkable given that the European benefit assessment (EU-HTA) was launched on January 12, 2025.
The discontinuation of the European reference pricing in Germany is a result of the new option for a confidential reimbursement amount which is also due to the implementation of the MFG. Since the option of a confidential reimbursement amount leads to a restriction of price transparency for other European countries, the legislator decided that Germany should no longer refer to other European countries as well. It is important to note that the discontinuation of the European reference pricing in Germany will affect all price negotiations henceforth, yet the confidential reimbursement amount only applies to those medicinal products for which the pharmaceutical entrepreneur chooses this option. The implementation of the confidential reimbursement amount will have repercussions for other European countries, as the actual prices will be partially concealed.
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