TGA Review Panel to Review Medicines and Medical Device Regulation

The Australian Government announced on 24 October 2014 that a panel of three experts would conduct an independent review of the regulation of medicines and medical devices, to examine specific aspects of the regulatory framework administered by the Therapeutic Goods Administration (TGA).29

The Review conducted by Emeritus Professor Lloyd Sansom AO, Mr Will Delaat AM and Professor John Horvath AO will, focus on identifying:

  • areas of unnecessary, duplicative or ineffective regulation that could be removed or streamlined without undermining the safety or quality of therapeutic goods available in Australia;
  • opportunities to enhance the regulatory framework so that Australia will remain well positioned to effectively respond to global trends in the development, manufacture, marketing and regulation of therapeutic goods.

According to the Terms of Reference30, the Review will make recommendations to:

  • ensure there is an appropriate balance between risk and benefit in the regulation of prescription, over-the-counter, complementary medicines and medical devices, as well as access for individuals to unapproved medicines and medical devices;
  • simplify and streamline the approval processes undertaken by the TGA, including recommendations on:
    • fast tracking approvals processes for medicines and medical devices;
    • opportunities for working together with overseas regulators; and
    • exploring how risk assessments, standards and determinations of regulators can be used more extensively by Australian regulators when approving the supply of medicines and medical devices;
  • ensure regulatory arrangements are flexible to accommodate developments in medicines and medical devices, including streamlining of cross-category regulatory approvals;
  • improve processes that assist industry, researchers and consumers to navigate the regulatory system;
  • support work underway on medical device reforms and clinical trial approval arrangements; and
  • any other matters that the review committee regards as important and relevant to the safe and efficient supply of effective medicines and medical devices to the Australian people. However, the Review will not make recommendations in relation to:
  • any aspect of the Pharmaceutical Benefits Scheme;
  • work by the Department of Health on the reimbursement systems;
  • National Health and Medical Research Council arrangements relating to research and development; or
  • work currently underway by the Department of Health and the Department of Industry on ethics processes for clinical trials

The Panel held a forum on 12 November 2014 for peak consumer, health professional and industry bodies to brief them on the process for the Review and opportunities to engage with the Panel31. On 21 November 2014, the Panel called for submissions from interested parties in response to its Discussion Paper32, which closed on 5 January 2015.

The Review report is scheduled to be provided to the Minister for Health, Prime Minister, Assistant Minister for Health, and the Parliamentary Secretary to the Prime Minister responsible for deregulation, by 31 March 2015.

Footnotes

29 The Hon Peter Dutton MP and Senator The Hon Fiona Nash, Joint Media Release 'Expert Panel to Review Medicines and Medical Devices Regulation' (24 October 2014) < http://www.health.gov.au/internet/ministers/publishing.nsf/Content/health-mediarelyr2014-dutton091.htm >.
30 The Department of Health, 'Review of Medicines and Medical Devices – Terms of Reference' < http://www.health.gov.au/internet/main/publishing.nsf/Content/8ADFA9C C3204463DCA257D74000EF5A0/$File/Terms%20of%20Reference%20-%20PDF%20 Version.pdf >.
31 The Department of Health, 'Expert Review of Medicines and Medical Devices Regulation' (20 January 2015) < HTTP://WWW.HEALTH.GOV.AU/INTERNET/MAIN/PUBLISHING.NSF/CONTENT/EXPERTREVIEW-OF-MEDICINES-AND-MEDICAL-DEVICES-REGULATION >..
31 Emeritus Professor Lloyd Sansom AO, Will Delaat AM and Professor John Horvath AO, 'Review of Medicines and Medical Devices Regulation Discussion Paper' (November 2014) < HTTP://WWW.HEALTH.GOV.AU/INTERNET/MAIN/PUBLISHING.NSF/CONTENT/8ADFA9CC3204 463DCA257D74000EF5A0/$FILE/REVIEW%20OF%20MEDICINES%20AND%20MEDICAL%20 DEVICES%20REGULATION%20DISCUSSION%20PAPER.PDF >..

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