On 25 June, the Therapeutic Goods Amendment (2020 Measures No. 1) Act 2020 (Cth) (‘the Act’) received assent. The Act makes several amendments to the Therapeutic Goods Act 1989 (Cth) (“the Principal Act”). In his second reading speech, Mr Mark Coulton, the Minister for Regional Health, Regional Communications and Local Government, highlighted three main changes made in the Act:
Firstly, the Act amends the definition of “medical device” and other related definitions to more closely align with the equivalent definitions used by the European Union (‘EU’). For instance, the Act clarifies that software, implants and reagents are medical devices if they are used for human beings for one or more of the purposes. According to the Explanatory Memorandum, these amendments are intended to “reduce the delay for Australian consumers in accessing new medical devices”, by minimising the differences between the Australian and EU regulatory frameworks for medical devices.
Currently, in order to register a new medicine in the Australian Register of Therapeutic Goods (‘the Register’), a person must submit a registration application to the Secretary of the Department of Health (‘the Secretary’). The application requires documented evidence that sufficiently indicates that the medicine meets appropriate standards.
Prior to the Act, support documentation was the only form of guidance available for medical sponsors when preparing their registration application as they were unable to obtain advice from the Secretary until after submitting their application. Support documentation is publicly available information that provides applicants (medical sponsors) with guidance as to the relevant information required for a successful application. However, the Explanatory Memorandum states that support documentation alone often fails to cover the diversity and complexity of various medical products. Due to confusion and uncertainty, sponsors risk both preparing evidence that is irrelevant and failing to provide relevant data, often at the expense of time, effort and resources.
The Act amends the current framework by enabling sponsors to directly request early scientific advice concerning the quality, safety and efficacy of a registrable medicine before submitting a registration application. According to the Minister’s Second Reading Speech, the purpose of these amendments is to “better support the timely availability of medicines for Australians”.
The Act also introduces a targeted data protection scheme for assessed listed medicines. Assessed listed medicines are medicines that are listed in the Register but are assessed by the Secretary in relation to their claims for efficacy before they are given marketing approval. The data protection scheme is intended to implement recommendations made by the Expert Panel Review of Medicines and Medical Devices Regulation focused on improving competitiveness of the Australian complementary medicines industry by providing incentives for innovation.
The scheme operates by providing a period of five years’ protection for clinical trial information that a sponsor of an assessed listed medicine submits for a registration application. The Act establishes a criteria for what information is classified as “restricted information”. This criteria requires that the information is:
Further, the medicine itself must be listed in the Register and at the time of application, no other listed medicine had the same indication. According to the Explanatory Memorandum, this effectively precludes sponsors of other “generic” assessed listable medicines from relying on such restricted information to support their own registration application. The Memorandum states that this will consequently provide “significant incentive for assessed listed medicine sponsors to undertake and invest in research to improve the efficacy of their products.”
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Therapeutic Goods Amendment (2020 Measures No. 1) Act 2020 (Cth), Bill and explanatory materials available from TimeBase's LawOne Service
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