Title: Causes of drug shortages in the legal pharmaceutical framework
Authors: De Weerdt, Elfi ×
Simoens, Steven
Hombroeckx, Luc
Casteels, Minne
Huys, Isabelle #
Issue Date: Mar-2015
Publisher: Academic Press
Series Title: Regulatory Toxicology and Pharmacology vol:71 issue:2 pages:251-258
Different causes of drug shortages can be linked to the pharmaceutical legal framework, such as: parallel trade, quality requirements, economic decisions to suspend or cease production, etc. However until now no in-depth study of the different regulations affecting drug shortages is available. The aim of this paper is to provide an analysis of relevant legal and regulatory measures in the European pharmaceutical framework which influence drug shortages.
Different European and national legislations governing human medicinal products were analyzed (e.g. Directive 2001/83/EC and Directive 2011/62/EU), supplemented with literature studies.
For patented drugs, external price referencing may encompass the largest impact on drug shortages. For generic medicines, internal or external reference pricing, tendering as well as price capping may affect drug shortages. Manufacturing/quality requirements also contribute to drug shortages, since non-compliance leads to recalls. The influence of parallel trade on drug shortages is still rather disputable.
Price and quality regulations are both important causes of drug shortages or drug unavailability. It can be concluded that there is room for improvement in the pharmaceutical legal framework within the lines drawn by the EU to mitigate drug shortages.
ISSN: 0273-2300
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Clinical Pharmacology and Pharmacotherapy
Department of Pharmaceutical & Pharmacological Sciences - miscellaneous
× corresponding author
# (joint) last author

Files in This Item:
File Description Status SizeFormat
07-01-2015_Causes of drug shortages in the legal framework- met REFERENTIES.pdf Published 564KbAdobe PDFView/Open


All items in Lirias are protected by copyright, with all rights reserved.

© Web of science