The German Federal Joint Committee will publish its early benefit assessments in English as well as German, following adoption of the TSVG law earlier in 2019.
The Term Service and Supply Act (TSVG) was brought into force in May 2019, and required the Gemeinsamer Bundesausschuss (GBA – Federal Joint Committee) to make its decisions more widely open to non-German speakers by including an English language version of the documentation.
The early benefit assessment is the first key stage of the AMNOG process, and allows patients access to new medicines for one year, after which further assessment and price negotiations are completed. Making decisions available in English should assist both patients and manufacturers in understanding the nature of medicines passing through this stage of market access in Germany. G-BA says:
“The translation serves to inform the international professional public; however only the German-language resolution is legally binding.”
– G-BA press release