Disappointment on the Passing of the Amendment to the Drug Law

Friday, 19 June was a long day for members of the Bundestag (Lower Chamber). The debates went on until well in the night - the idea was to vote on a number of bills before the election campaign and the summer adjournment. Unfortunately, this included the 15th amendment to the Drug Law. During a hearing at the Bundestag held at the beginning of May, BIO Deutschland had already urged that the path to the development of innovative medication by small and medium-sized companies should not be blocked. The background was that the chronically under-financed statutory health insurance companies had ensured that in the new version of the law, medication for which there is no therapeutic alternatives and that is still at the licensing stage, be provided by the manufacturers free of charge to patients with life-threatening conditions. BIO Deutschland strongly criticised this measure, stating in a paper drafted by its Working Group on Health Policies that while on the one hand it was true that a drug could only be marketed after being licensed, on the other innovative companies should retain the chance to receive payment for the provision of unlicensed drugs in hardship cases. Alternative payment models that would not necessarily place a burden on the statutory health insurance companies would only be possible if free provision were not compulsory, but rather were dealt with in a flexible way.

The text of the statement by BIO Deutschland is available at:
"Position Papers"

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