MAP Germany


Germany is the largest EU state by population, the largest EU economy and accordingly the most important market for pharmaceuticals within the European Union. For a long time manufacturers were effectively free to determine the reimbursement price of patented drugs in the German health care system. In recent years, however, pricing and reimbursement in Germany has changed significantly. In January 2011 a new system was introduced to determine the reimbursement prices of new active substances entering the German market. This new system, known as the “AMNOG System” foresees a 2-step procedure which new medicines have to undergo as soon as they enter the German market.

The first step is an assessment of the medicine’s additional benefit over a comparator product by an administrative body. The second step are price negotiations between the manufacturer and the statutory health funds which are based on the results of the benefit assessment. This website has been designed to support you when navigating the AMNOG-System to prepare the successful launch of innovative pharmaceuticals in Germany.

The AMNOG-System is a quite recent concept (est. 2011) and is considered to be a “learning system” by the German legislator and the administrative bodies involved. Although outcomes differ due to differences in the value demonstration, the AMNOG can be considered a rather predictable process. However, certain aspects are still being shaped and substantiated by court decisions, law decrees and, most of all, the administrative practice of the authorities involved.

For a more detailed breakdown of Germany’s healthcare economy and pharmaceutical industry, refer to our Germany section on MAP Europe.
Please see our Germany news for all the latest market access updates.

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