The law reforming the pharmaceutical market in Germany (ArzneimittelmarktNeuordnungsgesetz – AMNOG) took effect in January 2011.
Germany has kept the the principle of free pricing at launch but imposed a systematic and formal assessment of the “added therapeutic benefit” of new medicines - in order to negotiate the price according to the therapeutic value of the drug within twelve months after market launch.
Unlike many other countries, the basket of pharmaceutical drugs reimbursed by the Statutory Health Insurance in Germany is not defined through a positive list. All medicines entering the market are reimbursed by sickness funds unless they belong to a category excluded by law (e.g. OTC) or by a decision of the G-BA (Federal Joint Committee - Gemeinsamer Bundesausschuss).