Access to information about drugs in Australia

Consumers have a right to know why some drugs are approved and some are not.
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  • Updated:9 Jul 2007

01.Access to information about drugs in australia

Three red and white capsules

The issue

Prescription, over the counter and complementary medicines are approved for sale and marketing by the Therapeutic Goods Administration (TGA). The TGA is an Australian Government Agency which is a unit of the Commonwealth Department of Health and Ageing.

The TGA lacks transparency and independence. It does not disclose information about why certain drugs have been approved and others have not. The minutes for some meetings are published but they are always edited versions. Commercial confidentiality has been cited as an excuse for too long. Consumers in other countries including those in the UK and US are able to have access to this information and Australian consumers should be able to do the same.

Since 1998 the TGA has been operating on a 100% cost recovery model. This means that even though it is a Government agency, it no longer receives funding from Government. It generates revenue from fees, charges and annual registration fees from industry. Evidence suggests that the cost recovery model lead to reduced drug approval processing times in the UK by 24% within one year.

Reports by Deloitte and the National Audit Office found that the TGA lacks clear accountability for operational processes, a certified quality system and an adequate community engagement charter.

A joint regulator for Australia and New Zealand

The Australian and New Zealand Governments have been working to establish a joint regulatory agency called the Australia New Zealand Therapeutic Products Authority (ANZTPA). This was to be established by the end of 2007.

In July 2007, the New Zealand Government announced that it would not be proceeding with the establishment of the joint agency because it does not have sufficient support to ensure the passage of relevant legislation through New Zealand Parliament. Uncertainty now surrounds the way forward for the trans-Tasman harmonisation and many of the changes associated with it, including the establishment of a consumer consultation committee.

What we want

A more independent and transparent regulator that makes information about its decisions available to the public. More specifically we want:

  • A new website which is more ‘consumer friendly’ meaning easier to navigate and which makes relevant information available to consumers. This information shouldn’t simply be reshuffled with a new look but should provide better access to more information. For example, not just edited versions of certain committees.
  • More consumer involvement on various committees. We want to see a consumer consultative committee with an independent Chair which meets several times a year to be established by March 2007.
  • Clarification on what will happen now ANZTPA will not proceed.

What we’re doing

We have met with the TGA on several occasions and are advocating for the establishment of a consumer consultative committee, a more ‘consumer friendly’ website and information about ANZTPA.

More information

TGA transparency and independence, Consuming Interest Summer 2006.
TGA transparency and independance - Engaging Citizens, Consuming Interest Summer 2006.



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