Drafting of a Table Guidance on Off Label Use for the ICH-Data Driven Drug Development and Marketing Authorization
Keywords:
Off-Label-Use, Drug prescription, Knowledge Data base, German Drugs Law (AMG)Abstract
Among health care professionals, in particular in Germany, a legal uncertainty as to what medical uses exactly fall under the term of off-label-use is noticeable. The lack of a common definition complicates comparison of methods of resolutions in different countries. A current ambiguity is shown to cause false patient education and invalid informed consent, hence leading to liability concerns. Health care professionals are in need of drug information to assure safety of treatment, but legislative hurdles may hinder access to information while at the same time broad dissemination of off-label information is considered a risk of circumventing marketing authorization. The situation described above has motivated to develop in the framework of this research techniques on the model of UK NHS trust’s guidance to thus assure safe off-label-use. The chief purposes of this study on the off-label-use practices in Germany are in the short term to. • draft a legal concept for a safe off label use • draft an off label prescribing, supply and use of medicines policy • draft guidance for dissemination of information on unapproved uses of medical products Additionally for the long term a Drafting of data capturing requirements and Drafting of a mechanism to generate data driven templates or negative pledges on off label use are needed to be considered. This article describes concrete examples of the German Off-Label-Use Is-situation with regard on the German Drugs Law (AMG) and some juridical decisions (e.g. Nikolausurteil-Federal lawsuit decision from 06.12.2005, Az: 1 BvR 347/98). It further presents the results of the survey we had conducted in 2013/2014, a concept for safe Off-Label-Use and treatment, based on the recent research works (survey, discussion with the different actors- medical doctors, pharmacists, Health Insurances, Health authorities) for the future, and in particular for enabling more certainty among the health professionals.
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