The new article highlights the aspects related to the review procedures, and emphasizes the involvement of the administrative tribunal.
Table of Contents
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to requests for reconsideration of an initial decision. The document describes in detail the approach to be applied by the parties affected when requesting a regulatory decision be reviewed and reconsidered.
The guidance provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance therewith. At the same time, provisions of the guidance are non-binding in their legal nature, and they are not intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes thereto, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
New Information on Review
The scope of the guidance covers, inter alia, the review conducted based on the new information becoming available in line with Section 60A of the Therapeutic Goods Act. In particular, the affected party may request a review of the regulatory decision taken and provide new information to support this request.
When reviewing such a request, the Minister should either:
– Take that information into account upon reconsideration for the initial decision; or
– Remit the matter to an authorized delegate for a fresh decision.
It is also important to mention that, for the purpose of this rule, the concept of “new information” applies to the information that was not provided for the initial review even though it already existed at that time, and is also relevant to the matter in question.
Should the second approach be applied, a fresh decision would be taken as if there is a new application submitted. The affected party will be notified of the decision taken within 60 calendar days from the date the request was submitted, so should no response be received by an affected party within the aforementioned timeframe, it should be considered that it was a decision taken to uphold the initial decision and leave it unchanged.
Withdrawal
In accordance with the applicable regulatory requirements, an affected party applying for a reconsideration of the initial decision may withdraw its request at any time, provided there has been no decision taken with respect to such a request. The authority further encourages the parties involved to notify the authority of their intent to withdraw the request for review and reconsideration without undue delay.
Administrative Appeals Tribunal
The scope of the guidance also covers aspects related to the Administrative Appeals Tribunal (AAT), which is a Commonwealth administrative body that reviews a wide range of decisions made by Australian Government ministers, departments, agencies, and some other tribunals; the AAT takes a fresh look at a decision and, based on all evidence before the AAT, makes the “best of preferable decision” in the circumstances.
The applicable legislation entitles the affected party to apply to the AAT, requesting a decision taken by the Minister be reviewed and reconsidered, should the affected party be dissatisfied with such a decision. In accordance with the general requirements set forth by the Administrative Appeals Tribunal Act 1975, the appropriate application should be submitted in writing no later than 28 days from the date the notice of reconsideration has been given. However, in certain cases, an extension could be requested.
In order to apply for a review and reconsideration by the AAT, an interested party should complete the appropriate form available on the Tribunal’s website and submit it electronically or via mail. It is important to mention that a special fee could apply for the said submission.
In accordance with the procedure, the Tribunal will notify the Minister about the application for review submitted with respect to the decision taken by the Minister. The latter would then have to provide the reasoning behind the decision taken, as well as any other documents the Tribunal would reasonably need to assess the case within the same timeframe of 28 days from the date the appropriate notice is received from the Tribunal.
The authority additionally emphasizes that after an application for review of a reconsideration decision is made to the AAT, the TGA is unable to vary the reconsideration decision and substitute a new decision, unless the applicant and the Tribunal consent to the making of the alternation. The appropriate procedure for alternations and respective consents is set forth by the regulations governing the operations of the Tribunal.
Once the documentation related to the case is provided by the Minister, the Tribunal would initiate a conference to which all the parties involved would be invited. The purpose of such a conference will be to identify issues in dispute, negotiate a settlement of the case, or, if a settlement is not possible, prepare a matter for hearing. In order to organize and streamline this process, the Tribunal will set forth specific timeframes for the parties involved to provide the evidence they deem necessary to support their positions.
The procedure also provides for a voluntary mediation process to be initiated once the parties involved have agreed on it. At this stage, it will be possible to negotiate the way the case could be resolved, while the Tribunal will assist in finding a mutually acceptable solutions as an independent third party. It is important to mention that, in accordance with the rules of the respective procedure, the Tribunal would neither decide on the merits nor instruct the parties on the actions to be taken but rather advise and assist.
Should the parties fail to reach a mutually acceptable solution in the course of the voluntary mediation procedures described hereabove, the case will be further reviewed in the course of a hearing, during which all the parties involved would present their positions before the Tribunal. As a result, the Tribunal would render its verdict based on the information provided. The decision taken upon hearing, as well as the hearing itself, could be publicly available.
In summary, the present TGA guidance highlights specific aspects related to requests for review and reconsideration of the initial decision. The document describes the applicable timeframes, and also explains the procedure involving the Tribunal.
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