Linda Reynolds (WA, Liberal Party, Assistant Minister for Home Affairs) Share this | Link to this | Hansard source

I table a response to a question taken on notice during question time on 27 November 2018 asked by Senator Griff, in relation to the Prostheses List Advisory Committee, and seek leave to have the document incorporated in Hansard.

Leave granted.

The document read as follows—

Dear Mr President

I write with regard to three questions I took on notice from Senator Griff during Question Time on Tuesday 27 November 2018.

1. Will the Government consider referring all device approvals via the clinician based Prosthesis List Advisory Committee?

Ican advise the Senate that the Government will not consider referring all device approvals via the clinician based Prosthesis List Advisory Committee.

The role of the Prostheses List Advisory Committee (PLAC) is to provide advice to the Minister for Health on the benefits that private health insurers must rebate for implantable medical devices listed on the Prostheses List. The PLAC remit does not include regulatory assessment of safety, quality and performance.

The TGA has a number of in-house clinicians from a range of specialties who are employed to review clinical evidence submitted to establish the safety, quality and performance of medical devices, including implantable medical devices.

The TGA's Advisory Committee on Medical Devices has a current membership of 16 drawn from a broad range of clinical specialists and is a key advisory mechanism that meets formally seven times each year to consider and provide advice to the TGA on both pre market device assessment and post market device monitoring. Additional out-of-session meetings and teleconferences are also convened as required.

The TGA regularly invites relevant clinicians as expert assessors from the Clinical Advisory Groups (under PLAC) and other clinical specialists within Australia to assist with specific medical device assessments or reviews or who contribute to advisory groups as needed. The TGA has an expert panel of clinical experts that are also available as needed.

2. Can you provide on notice how many of these non-approved FDA export only devices are currently in circulation in Australia and the average adverse event rate compared to the FDA fully approved devices?

I can advise the Senate there is no mechanism for the TGA to:

cross reference with the US FDA device list to identify devices in the Australian Register of Therapeutic Goods that are included as export only in the USA;

identify the numbers of devices supplied unless a request to each sponsor is sent under the powers of the TGA Act; or

The TGA will shortly commence consultation on scoping the feasibility of adopting a Unique Medical Device Identifier (UDI) system in Australia. The UDI system could provide a single, globally harmonised system for identification of medical devices within healthcare supply chains and clinical care systems. Introduction of a UDI will require both legislative and regulatory amendments but aims to improve the monitoring of the performance of medical devices and reporting across jurisdictions, overcoming current barriers due to confusion created by the use of differing trade names, model numbers, etc.

It is important to note that a device's USFDA status as export only does not mean that an application to include the device for sale within the USA was rejected by the

USFDA. Further all devices seeking approval for supply in Australia must be assessed and approved by the TGA, regardless of their status with the USFDA.

3. Minister, the TGA, and would surprise a lot of people, only uses a paper based assessment for these devices and does not have an expert clinical committee to review the suitability of devices in Australian public hospitals.

I advise the Senate that the TGA only accepts electronic applications for conformity assessment and inclusion in the Australian Register of Therapeutic Goods. The preferred method of receiving evidence submitted in support of those applications is in an electronic format, but TGA has no legislative mechanism available to reject evidence provided on paper and will assess information provided in this form.

I further advise the Senate that each application for medium and high risk devices are reviewed by a multi-disciplinary team of assessors including medical officers, engineers and biomedical scientists (the team composition depends on the device type). In addition, the TGA has a fully equipped laboratory employing over 100staff that undertakes testing of medical devices.

The TGA does not evaluate the suitability of a device for use in any health facilities. Public hospital procurement activities fall within the remit of state and territory health departments.

I have copied this letter to the Minister for Health, the Hon Greg Hunt MP and the Senator for South Australia, Stirling Griff,

Yours sincerely

NIGEL SCULLION