Orphan Drug Programs/Policies in Australia, Japan, and Canada
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OO92-8615/2001 Copyright 0 2001 Drug Information Association Inc.
ORPHAN DRUG PROGRAMS/POLICIES IN AUSTRALIA, JAPAN, AND CANADA DRUSILLA L. Scon, PHD Pfizer Global Research and Development, AM Arbor, Michigan
SUSANALDER,MBBS, PHD Therapeutic Goods Administration, Canberra, Australia
ETSUKOUSUI AstraZeneca K.K., Osaka, Japan
KAROLYN LUI Therapeutic Products Programme, Health Canada, Ottawa, Canada
Australia, Canada, and Japan have evaluated how their governments can facilitate the development of medical products to treat rare disorders. Each has established programs andor policies to support the development of products to address unmet medical needs in small populations and to ensure their citizens access to such essential medicines. Japan implemented an Orphan Product Program in 1993. Australia ’s program, initiated in 1998, was developed in collaboration with the United States Food and Drug Administration to facilitate the exchange and review of data on orphan drugs. Canada’s assessment, published in 1996, determined that a standalone orphan drug program was not currently warranted, as existing legislation and regulatory policies allow early access to essential medicinal products. In reviewing these programs/policies along with those in the United States and Europe, it is interesting that only Japan designates medical devices as orphan products. Government grants for development are available in the United States, Canada, and Japan. Defined periods of market exclusivity apply in the United States and Europe. Market exclusivity is based on normal patent protection in Australia, Canada, and Japan; however, in Japan the time until generic competition is allowed is primarily defined by the reexamination period, which is extended for orphan products. All the policies allow regulatory fees to be waived or reduced, and a prioriry or accelerated review of the marketing application can usually be expected. Key Words: Orphan drugs; Rare disorders; Australia; Canada; Japan
INTRODUCTION
orphan medicinal products came into force. Between the enactment of these major pieces of legislation in the United States and Europe, policies and programs to encourage the development of products to treat rare disor-
THE UNITED STATES Orphan Drug Act became law in 1983, and in January 2000, the European Communities’ regulation on
Presented at the DIA 36th Annual Meeting, June 11-15, 2000, San Diego, California. Reprint address: Drusilla L. Scott, PhD, Director, Regulatory Affairs, Pfizer Global Research and Development, AM Arbor Laboratories, 2800 Plymouth Road, Ann Arbor, MI 48105. E-mail: [email protected].
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D. L. Scott, S. Alder, E. Usui, and K. Lici
ders were put in place in other major regions of the world. This paper will describe the history and current status of policies and programs in Australia, Japan, and Canada that support the development of, and access to, products to treat rare diseases. These programs will also be co
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