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Generic drug policies

Chapter in book
Authors Helle Håkonsen
Else-Lydia Toverud
Published in Encyclopedia of Pharmacy Practice and Clinical Pharmacy
Pages 130-138
ISBN 978-0-12-812735-3
Publisher Elsevier
Place of publication The United Kingdom
Publication year 2019
Published at Institute of Medicine, School of Public Health and Community Medicine
Pages 130-138
Language en
Subject categories Social and Clinical Pharmacy


Generic drugs are medicinal products that can be manufactured and marketed by others than the innovator company after the original patents have expired. Bioequivalence is the main regulatory principle for generic drug approval in European Union and the United States. For two drugs to be bioequivalent, they have to contain identical amounts of the same active ingredient in the same strength and dosage form and their bioavailabilities have to be similar in such a degree that their effects can be expected to be essentially the same. There are two main categories of generic drug policies: supply-side and demand-side policies. Supply-side policies comprise regulation of generic drug approval and market access, pricing, reimbursement, and tendering. Generic prescribing, generic substitution, prescribing budgets and indicators, targeted information, academic detailing, and public information campaigns are examples of demand-side policies. The ultimate aim of these policies is to increase the global access to and regulation of generic drugs, reduce drug costs, and prevent drug shortages and supply disruption. Particularly, the availability of low-priced generic drugs is important to increase the economical access to drug treatment in low- and middle-income countries. Despite this, most of the existing policies remain unimplemented in the less mature health care systems.

Page Manager: Webmaster|Last update: 9/11/2012

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