Orphan Drug Programs/Policies in Australia,Japan,and Canada

Abstract

Australia, Canada, and Japan have evaluated how their governments can facilitate the development of medical products to treat rare disorders. Each has established programs and/or 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 priority or accelerated review of the marketing application can usually be expected.