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Media releases 15 Sep 2016

Federal government to fast-track approval process for new drugs

Breast Cancer Network Australia has welcomed today’s announcement by Federal Health Minister Sussan Ley that will see some new cancer drugs, including drugs for metastatic breast cancer, made available in Australia more quickly than they are under the current approval processes.

The Minister has announced that Australia’s drug regulatory authority, the Therapeutic Goods Administration (TGA), will be able to fast-track the approval and sale of new drugs that have been listed by reputable overseas drug regulators such as the US Food and Drug Administration and the European Medicines Agency.

At present, Australians can wait up to two years longer than people in the US and Europe to access the latest breakthrough drugs. This can cause great distress for Australians with breast cancer who may be able to benefit from a new drug treatment but are unable to access it in Australia.

The TGA will now be able to use information and evidence already collected by overseas drug regulators. This will speed up the approval process in Australia. Overseas pharmaceutical companies will also now be able to list their new medicines in Australia at the same time as they are listed overseas.

Health Minister Sussan Ley says this move is about making sure Australians aren’t missing out on access to new medicines.

BCNA welcomes this change, which we believe will help some Australians living with breast cancer to access new medicines sooner and more easily.

It is important to note, however, that new drugs coming onto the market after approval by the TGA are likely to be very expensive as they will not be immediately or automatically listed on the Pharmaceutical Benefits Scheme (PBS). This means that while they will be available to purchase in Australia, they will be unaffordable for many individuals and families, and so beyond their reach.

The process for listing drugs on the PBS is separate to the TGA process. A 2013 study found the average time period between a new cancer drug receiving TGA approval for use in Australia and the listing of the drug on the PBS was at least 14 months. (Deloitte Access Economics, Access to cancer medicines in Australia, Medicines Australia Oncology Industry Taskforce, July 2013)

BCNA has been working with stakeholders to advocate for changes in drug approval processes so that new cancer drugs are:

  1. made available within Australia more speedily; and
  2. listed on the PBS on a more timely basis so that they are affordable to all Australians who can benefit from them.

BCNA commends the Health Minister on this initiative to make new drugs available sooner.

More information

Read BCNA’s submission to The Senate Community Affairs Committee into the availability of new, innovative and specialist cancer drugs in Australia.