Reform of Australian Orphan Drug Program - transition arrangements

The criteria of Australia’s Orphan Drug Program, which provides an incentive for sponsors to bring medicines for a small population to market that might otherwise not be available in Australia, have not been reviewed in almost 20 years and changes to the Program are required to ensure that it is still fulfilling its intended purpose, the Therapeutic Goods Administration (TGA) announced today.

In 2015 and in late 2016, the TGA consulted publicly on options for changes to the Australian Orphan Drug Program. These consultations have resulted in soon-to-be introduced reforms that will create a fairer Program that aligns more closely with international criteria without impeding the availability of drugs for rare diseases.

Summary of proposed changes