The Bundesrat did not use its opportunity to challenge aspects of GSAV legislation when it approved it earlier this year, according to the BPI.
The Bundesrat (Federal Committee) has approved the GSAV – Gesetz für mehr Sicherheit in der Arzneimittelversorgung (Act for more safety in the supply of pharmaceuticals), merely “waving it through”, according to Dr Martin Zentgraf, Chairman of the Board of the BPI – Bundesverbandes der Pharmazeutischen Industrie (Federal Association of the Pharmaceutical Industry).
Dr Zentgraf said:
“Contrary to the recommendation of the Health Committee of the Federal Council and against all reasonable arguments of the non-affirming states, among other things, the critical import import clause and the rebate contract arrangements, the Conciliation Committee is not called. A missed opportunity.”
GSAV was initially drafted in November 2018 in response to drug scandals in Germany and is aimed at tightening safety in the supply of pharmaceuticals. It is expected to come into force in July 2019. A description of the GSAV and what it means can be found on MAP Online here.
Read Dr Zentgraf’s statement here.