title: [The German Pharmaceutical Market Reorganization Act (AMNOG) from an economic point of view].
abstract: Since the introduction of early benefit assessments in Germany, prices for new medicinal products are set in accordance with the "degree of additional benefit." The major aim of the present work is to point out the economic rationale for the definition of a regulatory price for patent-protected drugs. With regard to the economic objectives of efficient allocation of resources, reducing information asymmetries, and promoting high-value innovation, the applied benefit assessments represent major progress in the German health care sector. In addition to the multifaceted criticism of procedural details, there is a general risk that the institutions involved are lagging behind societal preferences. In this case, early benefit assessments may lead to suboptimal results. The pharmaceutical industry's ability to innovate, on the other hand, may be seen to be a result of the interaction between national benefit assessments and the research activities of internationally oriented drug manufacturers. Accordingly, recent trends toward the implementation of national early benefit assessments in combination with international reference pricing may be seen to be critical; however, Germany is merely following the trend of other countries.
authors.affiliation: Institut für Medizinische Biometrie und Statistik, Universitätsklinikum Freiburg, Stefan-Meier-Str. 26, 79104, Freiburg, Deutschland, kaier@imbi.uni-freiburg.de.
authors.forename: Klaus
authors.initials: K
authors.lastname: Kaier
authors.forename: Stefan
authors.initials: S
authors.lastname: Fetzer
mesh_terms: D003362:Cost-Benefit Analysis / Q000191:economics / Q000331:legislation & jurisprudence; D016527:Drug Costs / Q000331:legislation & jurisprudence*; D005858:Germany; D033161:Government Regulation; D006301:Health Services Needs and Demand / Q000191:economics* / Q000331:legislation & jurisprudence; D007880:Legislation, Drug / Q000191:economics*; D055656:Prescriptions / Q000191:economics*; D018570:Risk Assessment / Q000191:economics* / Q000331:legislation & jurisprudence*