Development of Orphan Drugs under European Regulatory Incentives and Patent Protection

AbstractThis article analyses how the regulatory incentives provided by Regulation 141/2000 affect orphan drug development and generic market entry. It seeks to find out how the regulatory incentives work in combination with patent protection, and whether in combination they foster orphan drug innovation and overall patient access, or rather hinder the latter. The article argues that even though the regulatory incentives are targeted to fostering innovation and early generic market access, when combined with patent protection, the generic entry is likely blocked or delayed.

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Orphan Drugs: The Question of Products Liability

American Journal of Law & Medicine ◽

10.1017/s0098858800009424 ◽

1985 ◽

Vol 10 (4) ◽

pp. 491-513

Author(s):

Susan F. Scharf

Keyword(s):

Drug Development ◽

Orphan Drug ◽

Rare Diseases ◽

Tort Law ◽

Orphan Drugs ◽

Products Liability ◽

Liability Law ◽

Design Defect ◽

Liability Costs ◽

Orphan Drug Development

AbstractOrphan drugs, essential for die treatment of persons widi rare diseases, generally are unprofitable for manufacturers to develop and market. While congressional and administrative efforts to promote die development of orphan drugs have met widi modest success, application of products liability doctrine to orphan drug sponsors could subvert those efforts. This Note describes die provisions of die Orphan Drug Act and analyzes products liability law with respect to orphan drug litigation. It argues that die goals of tort law support the imposition of liability for design defect, failure to warn and negligence in testing. Finally, die Note acknowledges diat liability costs create disincentives for orphan drug development and suggests mechanisms for reducing manufacturers’ liability concerns.

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Letter from the Editors

Journal of Rare Diseases and Orphan Drugs ◽

10.36013/jrdod.v2i.33 ◽

2020 ◽

Vol 2 ◽

pp. 1

Author(s):

Editorial Office

Keyword(s):

Clinical Trials ◽

Medical Journal ◽

Open Access ◽

Drug Development ◽

Orphan Drug ◽

Rare Diseases ◽

Case Reports ◽

Orphan Drugs ◽

Original Research ◽

Orphan Drug Development

Last year we successfully introduced a new journal: The Journal of Rare Diseases and Orphan Drugs (JRDOD) is a peer-reviewed open-access medical journal that publishes original research, reviews, case reports, and letters covering a broad field of its specialty. We intend to publish articles stimulating to read, educate, and inform readers with the most up-to-date research in genetics, rare diseases, and new orphan drug development in different stages of clinical trials. Journal topics are centered on patients living with undiagnosed rare diseases, the importance of a diagnosis, individual approaches to treatments. We hope that this journal will increase awareness of many difficult to diagnosed and treat medical conditions.

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The role of globalization in drug development and access to orphan drugs: orphan drug legislation in the US/EU and in Latin America

F1000Research ◽

10.12688/f1000research.4268.1 ◽

2015 ◽

Vol 4 ◽

pp. 57 ◽

Cited By ~ 4

Author(s):

Renée J.G. Arnold ◽

Lida Bighash ◽

Alejandro Bryón Nieto ◽

Gabriela Tannus Branco de Araújo ◽

Juan Gabriel Gay-Molina ◽

...

Keyword(s):

Drug Development ◽

Orphan Drug ◽

Latin American ◽

Rare Diseases ◽

Market Access ◽

Orphan Drugs ◽

The United States ◽

Drug Status ◽

Drug Legislation ◽

The Us

Compared to a decade ago, nearly three times as many drugs for rare diseases are slated for development. This article addresses the market access issues associated with orphan drug status in Europe and the United States in contrast to the legislation in five Latin American (LA) countries that have made strides in this regard--Mexico, Brazil, Colombia, Chile and Argentina. Based on the success of orphan drug legislation in the EU and US, LA countries should strive to adopt similar strategies with regard to rare diseases and drug development. With the implementation of new targeted regulations, reimbursement strategies, and drug approvals, accessibility to treatment will be improved for people afflicted with rare diseases in these developing countries.

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