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Consultation: Supply of in vitro diagnostic devices for self-testing (home testing) for the presence of human immunodeficiency virus in Australia

8 July 2014

This consultation closed on 6 May 2014


In April 2014, the Department of Health in conjunction with the TGA wrote to a number of stakeholders seeking their views on a proposal to allow the registration and sale of in vitro diagnostic devices (IVDs) for self-testing for the presence of human immunodeficiency virus (HIV) in Australia. In particular, stakeholders were invited to comment on:

  • The risks and benefits of self-testing as a means to enable and promote timely HIV detection and increase testing rates overall, particularly amongst hard-to-reach population groups;
  • The risks and benefits of allowing TGA to approve such devices for HIV self-testing that are of acceptable safety and quality and perform as intended to increase HIV detection rates in Australia; and
  • Any limitations or conditions that should be placed on the supply of HIV self-testing devices.

According to the Kirby Institute Annual Surveillance Report on HIV, viral hepatitis and sexually transmissible infections in Australia for 2013, at the end of 2012 an estimated 28,000 - 34,000 people were living with HIV infection in Australia. Of these, approximately 25,700 were diagnosed with HIV infection. This means that as many as 30% of the HIV-infected individuals in Australia are undiagnosed and that more needs to be done to improve testing rates. The availability of a home testing option would assist in overcoming some common barriers to testing such as concerns regarding privacy and confidentiality.

Regulatory requirements have precluded IVDs for self-testing of HIV from being included on the Australian Register of Therapeutic Goods (ARTG). The effect of this is that these tests cannot be legally supplied in Australia. However, such IVDs may be imported by individuals for their personal use or that of members of their family. The quality, safety and performance of these imported devices have not been evaluated by the TGA, or in some cases, any regulator, and this presents a risk to individual and population health, where poor quality and unacceptable levels of test failure can have significant consequences.

After careful consideration of stakeholder comments a decision has been made by the Secretary of the Department of Health to enable IVD medical devices for HIV self-testing to be included in the Register. This decision is aligned with the direction set by the Seventh National HIV Strategy (2014-2017) and aims to increase detection of HIV in the community by enabling greater access to tests that have been assessed for quality, safety and performance by the TGA.

Specifically, the Therapeutic Goods (Excluded purposes) Specification 2010, which precluded the TGA from approving tests for use in this way for sale in Australia, has been amended. The effect of this amendment is that HIV self-tests can be included in the ARTG and legally supplied in Australia, subject to satisfying the applicable regulatory requirements.

Submissions received

The consultation on supply of in vitro diagnostic devices for self-testing (home testing) for the presence of human immunodeficiency virus in Australia closed on 6 May 2014.

The TGA would like to thank the individuals and organisations who made submissions in response to the consultation. Submissions for which the respondent has provided consent for publication have been provided below.

Parts of some submissions have been redacted where the redacted material would enable the identification of individuals other than persons who have lodged submissions to the review.

The names of submitters do appear, unless the submitter has requested their name/s to be withheld.

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