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Submissions received and TGA response: Review of the regulation of certain self-testing IVDs in Australia

9 September 2020

The TGA thanks individuals and organisations who provided submissions in response to the public consultation paper: Review of the regulation of certain self-testing IVDs in Australia

A total of 26 submissions were received, which comprised:

  • 9 from consumer organisations and individual consumer advocates
  • 5 from peak health professional bodies and individual health professionals
  • 4 from IVD manufacturers and peak industry bodies
  • 5 from State or Commonwealth government agencies
  • 3 from health research institutes or individual researchers

All submissions that gave permission to be published on the TGA website are now available below in PDF format.

Submissions received

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Summary of submissions

Self-tests for infectious diseases

There was support for a number of self-tests for infectious diseases to be made available in future. The majority of the submissions identified self-testing for influenza as an example where the benefits are likely to outweigh the risks.

A lesser number identified other self-tests which may also be safely supplied in future, including:

  • other respiratory infections such as respiratory syncytial virus (RSV);
  • hepatitis C virus;
  • blood borne viruses generally;
  • sexually transmitted infections; and
  • gastrointestinal and travel acquired infections.

At the same time, a number of submissions highlighted concerns that public health surveillance of serious infectious diseases may be compromised if self-testing for certain diseases were to be allowed.

Direct to consumer (DTC) genetic testing

The majority of submissions were strongly in favour of continued restrictions on supply of DTC genetic self-tests in Australia; highlighting a number of significant risks for health related purposes, concluding that the potential for harm is high and the benefits often doubtful. The need for pre-test discussion to determine the relevance of genetic tests, interpretation of results and post-test counselling by appropriate health professionals was emphasised in most submissions.

Several submissions highlighted problems with the current regulation of genetic testing including:

  • The availability and take-up of online services from overseas providers which circumvent the Excluded Purposes Specification and are not subject to Australia’s regulatory standards or laboratory accreditation requirements;
  • The trend for genomic information initially obtained for non-health purposes (such as fitness or ancestry testing) subsequently being used to reveal health-related information;
  • Interpretation of genetic test results can be difficult and inconclusive; which may lead consumers and their families down a difficult pathway with unintended consequences (psychological, financial, social);
  • Take-up of DTC genetic testing is already increasing the burden on general practitioners, clinical geneticists and other health professionals to assist in interpretation of test results that lack efficacy and clinical relevance.

In light of the consumer demand for genetic tests and the accessibility of these services from overseas providers, several submissions cautiously propose that some health-related DTC genetic tests could be considered for approval in Australia.

Some of the suggested approaches to this achieving this are:

  • The TGA engaging in a broad consultation with consumers, clinicians and other stakeholders to assess the risks, determine mitigation strategies and referral pathways into the health system;
  • Ensuring testing is supported by pre-test discussion and post-test counselling by appropriate health professionals;
  • Investing in infrastructure to ensure appropriate monitoring, accreditation and regulation of these tests;
  • Developing pathways for consumer access, information and support.

Some submissions suggest Australia should adopt a regulatory approach similar to the European Union (EU). There is already considerable similarity in regulation of IVDs in Australia and the EU but within Europe there are differences from country to country in how genetic testing is regulated. The TGA is currently exploring greater alignment with EU IVD regulations and will consider the specific approaches to regulation of genetic tests as part of that alignment.

Self-tests for detection and diagnosis of cancer

Several submissions specifically identified self-tests for cancer (except when used as part of national screening programs) as high risk and argue strongly that these should continue to be excluded. Some submissions were in favour of removing restrictions on self-tests generally, subject to risk assessment and mitigation, but none identified self-tests for cancer as bringing particular benefits to consumers.

Self-tests for other serious diseases

Most submissions did not comment on self-tests for serious diseases other than infectious diseases and cancer, and genetic testing for diseases and disorders. A few submissions favoured removing restrictions on self-tests generally, subject to favourable risk assessment and appropriate risk mitigation.

One submission specifically proposed that self-testing IVDs for some serious conditions such as diabetes, kidney disease and heart diseases might have benefits for early detection and treatment.

Summary of consultation and outcomes

Summary and outcomes: review of the regulation of certain self-testing in vitro diagnostic medical devices (IVDs) in Australia

The purpose of this document is to provide an overall summary of feedback received and outcomes of the consultation process to review the regulation of certain self-testing in vitro diagnostic (IVD) medical devices in Australia.

Next steps

Further detailed guidance on the TGA’s expectations, performance requirements and risk mitigations is being developed to assist sponsors and manufacturers in applying to include their self-testing IVDs in the Australian Register of Therapeutic Goods. Once finalised this guidance will be available on the TGA website.