AOP Orphan

Orphan disease criteria

In Australia, the administrative authority involved in orphan drug regulations, is the Therapeutic Goods Administration (TGA). TGA is part of the Australian government’s Department of Health & Ageing. The following are a few features of orphan drugs in Australia (per the OrphaNet portal) :

- Orphan Drug Policy set up in 1998

- Orphan designation is intended for drugs for rare diseases with prevalence of < 2, 000 patients in the total population of 18 million OR approximately 1 in 10, 000

- Waiver of application and evaluation and no annual registration fees

- 5-year exclusivity (similar to other drugs)

- All costs of the orphan drug designation process is covered by TGA

- R&D not supported by grants or tax incentives.

The Pharmaceutical Benefits Advisory Committee (PBAC) makes national funding decisions for the Australian public healthcare system. The PBAC assesses orphan drugs separately from non-orphan drugs using very strict criteria., for a description of the detailed set of steps for the assessment and reimbursement of orphan drugs in Australia.

Since 1995, the Life Saving Drugs Program (LSDP) in Australia provides subsidized access for life saving drugs meeting specific criteria for rare diseases. Reimbursement is provided through a separate budget. The LSDP is important to Australians with rare diseases because it ensures that patients have the same access to treatments as those suffering from common diseases.

A new organization, Rare Voices Australia (RVA), is recently created with the objective “to unite & represent the interests of all Australians living with a rare disease or disorder, and their families, as 1 voice, with the immediate aim of increasing both public & political awareness of the burden of rare disease ……”.

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