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Published on: May 12, 2018
[The AMNOG and its consequences]
1Institut für Pharmazeutische Biologe, Biozentrum, Goethe-Universität Frankfurt, Max-von-Laue-Str. 9, 60438, Frankfurt am Main, Deutschland. dingermann@em.uni-frankfurt.de
Abstract:
On 11 November 2010, the German Bundestag approved the law on the Reorganization of the Pharmaceutical Market (AMNOG). This act went into force on 01 January 2011. The aim was to "confine the rapidly rising pharmaceutical expenditure of public health insurance." A better way should be defined for a "fair competition" and a "stronger focus on the well-being of patients" through a new balance between innovation and affordability of medicines. Obviously, advocates and opponents of this new law argue differently. Those in favor of the AMNOG argue that a fair evaluation of the incremental clinical benefits of newly approved drugs should build the basis for fair price negotiations, that prices should be paid, which more realistically reflect the value of the innovation, and that the system will receive urgently needed relief from the immense burden of the rather small group of patent-protected drugs. Those opposing the new law see the danger of delayed launches or even withdrawals of new medicines that can benefit patients, erosion of Germany's strength in pharmaceutical innovation, and the loss of high-qualified and high-paying jobs in research and development.
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