Current Problems in Provision of Orphan Drugs and Ways to Solve Them

Despite the fact that orphan (rare) diseases are characterized by a very low prevalence rate, a considerable number of people worldwide suffer from these diseases. The United States and the European Union developed a variety of economic and administrative incentives for pharmaceutical companies to p...

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Main Authors: Alexei S. Kolbin, Roman A. Gapeshin, Stanislav M. Malyshev
Format: Article
Language:English
Published: "Paediatrician" Publishers LLC 2016-09-01
Series:Вопросы современной педиатрии
Subjects:
Online Access:https://vsp.spr-journal.ru/jour/article/view/1651
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author Alexei S. Kolbin
Roman A. Gapeshin
Stanislav M. Malyshev
author_facet Alexei S. Kolbin
Roman A. Gapeshin
Stanislav M. Malyshev
author_sort Alexei S. Kolbin
collection DOAJ
description Despite the fact that orphan (rare) diseases are characterized by a very low prevalence rate, a considerable number of people worldwide suffer from these diseases. The United States and the European Union developed a variety of economic and administrative incentives for pharmaceutical companies to produce orphan drugs, but their effectiveness is difficult to assess because of the small sample volume and complex organization of clinical trials. The average cost of orphan drugs is 5 times greater than that of the drugs used in the treatment of other diseases. Pricing mechanisms on orphan drugs are still poorly understood.
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publisher "Paediatrician" Publishers LLC
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series Вопросы современной педиатрии
spelling doaj-art-e6797533f54b43649e697a6af757af0d2025-08-20T03:01:18Zeng"Paediatrician" Publishers LLCВопросы современной педиатрии1682-55271682-55352016-09-0115434435110.15690/vsp.v15i4.15841612Current Problems in Provision of Orphan Drugs and Ways to Solve ThemAlexei S. Kolbin0Roman A. Gapeshin1Stanislav M. Malyshev2First Pavlov State Medical University of St. Petersburg, St. Petersburg, Russian Federation St. Petersburg State University, St. Petersburg, Russian FederationSt. Petersburg State University, St. Petersburg, Russian FederationFederal Almazov North-West Medical Research Centre, St. Petersburg, Russian FederationDespite the fact that orphan (rare) diseases are characterized by a very low prevalence rate, a considerable number of people worldwide suffer from these diseases. The United States and the European Union developed a variety of economic and administrative incentives for pharmaceutical companies to produce orphan drugs, but their effectiveness is difficult to assess because of the small sample volume and complex organization of clinical trials. The average cost of orphan drugs is 5 times greater than that of the drugs used in the treatment of other diseases. Pricing mechanisms on orphan drugs are still poorly understood.https://vsp.spr-journal.ru/jour/article/view/1651rare diseasesorphan drugsdevelopment
spellingShingle Alexei S. Kolbin
Roman A. Gapeshin
Stanislav M. Malyshev
Current Problems in Provision of Orphan Drugs and Ways to Solve Them
Вопросы современной педиатрии
rare diseases
orphan drugs
development
title Current Problems in Provision of Orphan Drugs and Ways to Solve Them
title_full Current Problems in Provision of Orphan Drugs and Ways to Solve Them
title_fullStr Current Problems in Provision of Orphan Drugs and Ways to Solve Them
title_full_unstemmed Current Problems in Provision of Orphan Drugs and Ways to Solve Them
title_short Current Problems in Provision of Orphan Drugs and Ways to Solve Them
title_sort current problems in provision of orphan drugs and ways to solve them
topic rare diseases
orphan drugs
development
url https://vsp.spr-journal.ru/jour/article/view/1651
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