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Orphan drugs and paediatric medicinal products
Journal
Pharmaceutical Policy and Law
ISSN
1389-2827
Type
journal article
Date Issued
2014-01-07
Author(s)
Sprecher, Franziska
Abstract
While the safety and availability of medicinal products for the majority of adult patients has steadily improved in recent decades, for children and people suffering from rare diseases (orphan diseases) there is a lack of approved medicinal products for these patient populations. Since the research and development of medicinal products is associated with high costs, the costs for paediatric medicinal products and medicines for rare diseases (orphan drugs) may barely be covered under normal market conditions due to the small patient populations. In order to prevent the continued exclusion of children and persons suffering from rare diseases from medical progress and to eliminate the deficits in the research and development of medicinal products for these patient groups, the European Union created, along the lines of the U.S. model, a system of incentives and constraints. Since 2000, under Regulation (EC) No. 141/2000 (Orphan Drug Regulation) there has been an incentive system to encourage the research and development of orphan drugs. With the goal of improving the health of children in Europe, Regulation (EC) No. 1901/2006 (Paediatric Regulation) combines economic incentives with the requirement to conduct paediatric studies. This article explains and comments on the specific regulatory framework for orphan drugs and paediatric medicinal products in the European Union.
Language
English
Keywords
European law
medical law
orphan drugs
orphan disease
paediatric medicinal products
Regulation (EC) No. 141/2000
EU orphan drug legislation
Regulation (EC) No. 1901/2006
EU paediatric legislation
EU pharmaceutical law
Swiss pharmaceutical law
Seltene Krankheiten
Medizinrecht
Heilmittelrecht
Heilmittelgesetz
HMG
Kinderarzneimittel
Arzneimittelrecht
orphan drugs
HSG Classification
contribution to scientific community
Refereed
No
Publisher
IOS Press
Publisher place
Amsterdam
Volume
15
Number
3-4
Start page
173
End page
194
Pages
22
Subject(s)
Division(s)
Eprints ID
229702