In November 2018, the German Health Ministry introduced a draft bill on safety in the supply of pharmaceuticals. The Gesetz für mehr Sicherheit in der Arzneimittelversor-gung (GSAV) bill aims, among other things, to provide a legal framework for the automatic substitution of biosimilars by pharmacists in Germany.

The German Health Ministry has introduced the new law in order to increase adoption of biosimilars, due to the huge potential for cost savings. As few European Union (EU) countries currently allow pharmacist substitution of biosimilars, this would represent a significant change in practice, particularly for Germany.

Negotiations between Germany’s lower house of parliament, Bundestag, and the Health Ministry on the GSAV are ongoing, but the proposal is that two substitution lists will be developed – a physician and a pharmacist list. The physician substitution list would contain information on how to switch to biosimilars, whilst the pharmacist substitution list would dictate which biosimilars were eligible for substitution at the pharmacy level.

Other practical details under discussion include the length of the transition period, the role the physician will play in treatment decisions and whether automatic substitution would apply to both treatment-naïve and existing patients. Although in Germany, the pharmacist may substitute a biosimilar as part of the obligatory generics substitution policy referred to as ‘Aut-idem-Regelung’ [1], a physician can tick a box on the prescription to forbid the pharmacist from making a substitution.

The law still has to be approved by the German Federal Council and is due to enter into force in the middle of 2019.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Germany’s rational use of medicines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 10]. Available from: www.gabionline.net/Reports/Germany-s-rational-use-of-medicines 

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