DefinitionThis section has been translated automatically.
Acronym for: Law on the reorganization of the pharmaceutical market
General informationThis section has been translated automatically.
On 1 January 2011, the Act on the Reorganisation of the Pharmaceutical Market (AMNOG) came into force. The law obliges pharmaceutical companies to submit a so-called early benefit assessment in addition to the marketing authorisation and thus to prove the additional benefit for new drugs (applies to all drugs authorised from 2011!). The additional benefit is to be demonstrated either in comparison to fixed-price drugs with which it is pharmacologically comparable or, in the case of innovative drugs, in comparison to an appropriate comparative therapy determined by the Federal Joint Committee. Furthermore, the price of the drug must be agreed with the statutory health insurance within one year. If no agreement is reached, a central arbitration board decides on the price of the drug with effect from the 13th month after market launch (§35a /130b SGB V). In this process, IQWiG (Institute for Quality and Efficiency in Health Care) can be commissioned as an "independent institute" to evaluate the additional benefit of drugs.
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The possibility of an "early benefit assessment" is questioned by many authors in chronic diseases.