German drug legislation moving forward

Germany's lower house of Parliament (Bundestag) passed legislation that eliminates benefit assessments of drugs that were launched before January 2011, when drug pricing law AMNOG came into effect. The legislation also extends Germany's drug pricing freeze -- which sets drug prices at 2009 levels -- through Dec. 31, 2017, and sets the country's mandatory drug rebates at 7%. The details were agreed upon in November during coalition talks to form a new government (see BioCentury Extra, Dec. 19, 2013).

The legislation includes an amendment that states that the price negotiated between a company and Germany's Statutory Health Insurance Funds Association (GKV-Spitzenverband) is used as the basis for discounts and taxes; in current practice, the list price is typically used. Trade associations have said the amendment would make negotiated prices public and lead to downward pricing pressures for European reference pricing. A government spokesperson who asked to remain anonymous said the legislation does not change the accessibility of negotiated prices, which are published in a database accessible only to health care professionals. The legislation also includes an amendment tasking Germany's Federal Joint Committee (G-BA) with creating a list of drugs for which another drug with the same active ingredient may not automatically be substituted. The amendment directs G-BA to focus on narrow therapeutic index drugs. ...