The document discusses various regulatory updates from the TGA regarding medicines and devices, focusing on HIV tests, including rapid and self-testing formats. It outlines submissions and recommendations from the AFAO concerning the medical device regulation review, as well as updates on the MBS listing process for rapid HIV testing. Furthermore, the national HIV testing policy is under revision to incorporate amendments, and expert groups are working towards finalizing policies by mid-2015.

1. Regulatory Update
Ben Wilcock
AFAO Members Forum
15 May 2015

2. Overview
 TGA Review of Medicines and Devices Regulation
 TGA review on the Proposed Performance Requirements
and Risk Mitigation Strategies for HIV Tests
 Rapid HIV tests currently being assessed by TGA
 MBS listing for rapid HIV testing
 National HIV Testing Policy

3. TGA Review of Medicines and Medical
Devices Regulation
 Large independent review examining TGA’s regulatory framework and
processes
– First stage:
 Prescription medicines
 Over-the-counter (OTC) medicines
 Medical devices
– Second stage:
 Complementary medicines
 Recommendations the review will make include areas such as:
– Ensuring an appropriate balance between risk and benefit
– Simplifying and streamlining approval processes (fast tracking approvals,
opportunities for working with overseas regulators)
– Process improvements that make navigation of regulatory system easier

4. TGA Review of Medicines and Medical
Devices Regulation
 First stage (prescription, OTC, medical devices):
– AFAO limited its submission to medical devices chapter –
specifically relating to rapid tests
– Submissions closed 5 January 2015
– Report provided to government by 31 March 2015
 Second stage (complementary medicines)
– Submissions closed 8 April 2015
– Recommendations to government mid-2015

5. TGA review on the Proposed
Performance Requirements and Risk
Mitigation Strategies for HIV Tests
 Smaller consultation by the TGA proposing the performance
requirements and risk mitigation strategies for HIV tests:
– Laboratory HIV tests
– Rapid HIV tests used at point-of-care
– Rapid HIV tests used for self-testing
 AFAO made no comment on laboratory testing and
concentrated its submission on rapid HIV tests, both for point-of-
care and self-testing use.

6. TGA review on the Proposed
Performance Requirements and Risk
Mitigation Strategies for HIV Tests
 Submissions closed 30 January 2015
 TGA’s document was published on their website in March 2015
 Overall, a very good step in the right direction
– Importantly, it identifies the different needs for specific types of tests
(eg rapid HIV tests) in different settings (eg both at point of care and
self-testing)
– Performance requirements (sensitivity and specificity) appear
reasonable
– Issue of what constitutes “supervision” seems now to be suitable for
models of AFAO’s state member organisations’ testing services
 direct and indirect

7. Rapid HIV tests currently being assessed
by the TGA
 Trinity Uni-Gold test:
– Original application was knocked back
– Sponsor appealed – appeal on hold for TGA review
– Outcome expected soon
 Orasure
– Original application also knocked back, also appealed
 No application has yet been made by a manufacturer for a rapid
HIV test for self-testing

8. MBS listing for rapid HIV testing
 Alere (manufacturer of currently only TGA-approved rapid HIV test,
Determine HIV Combo test) made an application to MSAC (Medical
Services Advisory Committee) in mid 2014
– the final protocol published on MSAC website early 2015.
 Alere’s original application included a limitation on the listing to
antigen/antibody combo tests (Determine is currently the only one
on the market).
– AFAO’s and other organisations’ letters of support to the original
application supported an MBS listing for rapid HIV tests including
combo and antibody only tests.
– Encouragingly this limitation doesn’t seem to appear in the final
protocol document.

9. MBS listing for rapid HIV testing
 Feedback from Alere earlier this year is unfortunately we are still some way
from a decision.
 A couple of processes/meetings as part of the MSAC process before the
final MSAC meeting
– Next MSAC meetings on end of July and end of November
 Alere doesn’t think those processes will have everything ready in time for
the June MSAC meeting – much more likely to be reviewed in November.
 If successful, MSAC then makes a recommendation to the Government and
then if the Government decides to act on that recommendation it could take
say 6 months for the Medicare schedule to be updated.

10. National HIV Testing Policy
 Several planned amendments that were being incorporated in the
latest review of the National HIV Testing Policy (eg the need to
remove regulatory restrictions to allow HIV self-testing) occurred
during the drafting of the latest version.
 The National HIV Testing Policy Expert Reference Group is
meeting in late May to finalise the revised policy.
 It will then be circulated to all jurisdictions and organisations for
their endorsement.
– Intended agenda item for a draft briefing at the next BBVSS meeting in
mid June.
– Then a briefing and final version sent to the Commonwealth, BBVSS
and MACBBVS for endorsement by all by August 2015.