Therapeutic Goods Amendment (2018 Measures No 1) Bill 2018 [2018] AUSStaCSBSD 185 (15 August 2018)

• Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018
• Incorporation of external material into the law 84

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Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018

Purpose	This bill seeks to amend the Therapeutic Goods Act 1989 to: • introduce mandatory reporting requirements for sponsors of prescription medicines to report shortages of, and any decision to permanently discontinue, their products; • enable standards to adopt other documents as in force from time to time; • enable the secretary to require priority pathway applicants to provide supporting information; • amend health practitioner notifications under the Special Access Scheme; and • vary registered medicines through notification
Portfolio	Health
Introduced	House of Representatives on 28 June 2018

Incorporation of external material into the law ^[84]

1.91 Item 2 of Schedule 2 seeks to amend section 10 of the Therapeutic Goods Act 1989 (the Act) to provide that, despite section 14(2) of the Legislation Act 2003, the minister may make an order specifying a standard for therapeutic goods or classes of therapeutic goods, or a variation of such an order, by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other writing as in force or existing from time to time.

1.92 At a general level, the committee will have scrutiny concerns where provisions in a bill allow the incorporation of legislative provisions by reference to other documents because such an approach:

• raises the prospect of changes being made to the law in the absence of parliamentary scrutiny, (for example, where an external document is incorporated as in force 'from time to time' this would mean that any future changes to that document would operate to change the law without any involvement from Parliament);

• can create uncertainty in the law; and

• means that those obliged to obey the law may have inadequate access to its terms (in particular, the committee will be concerned where relevant information, including standards, accounting principles or industry databases, is not publicly available or is available only if a fee is paid).

1.93 As a matter of general principle, any member of the public should be able to freely and readily access the terms of the law. Therefore, the committee's consistent scrutiny view is that where material is incorporated by reference into the law it should be freely and readily available to all those who may be interested in the law.

1.94 The issue of access to material incorporated into the law by reference to external documents such as Australian and international standards has been an issue of ongoing concern to Australian parliamentary scrutiny committees. Most recently, the Joint Standing Committee on Delegated Legislation of the Western Australian Parliament has published a detailed report on this issue. This report comprehensively outlines the significant scrutiny concerns associated with the incorporation of material by reference, particularly where the incorporated material is not freely available.

1.95 In this instance, the explanatory memorandum states that it is necessary to allow material to be incorporated from time to time so as to prevent therapeutic goods standards from referring to out-dated documents and becoming out of sync with international best practice,^[85] and also states that it is intended that the proposed power will be used to align the regulation of therapeutic goods with international best practice in relation to product safety and quality by requiring compliance with or references to other documents such as standards issued by the International Organization for Standards, the European Union or Australian Standards.^[86] The explanatory memorandum also includes examples of the types of documents that may be incorporated and notes that, while these documents are available online, in some cases an access fee applies. The explanatory memorandum finally states that it is expected that sponsors and manufacturers of therapeutic goods would have access to and be familiar with such documents.^[87]

1.96 The committee notes this detailed explanation and that the incorporated documents are likely to be readily accessible to those most directly affected by the standards. However, the committee emphasises that its consistent scrutiny view is that where material is incorporated by reference into the law it should be freely and readily available to all individuals who may be interested in or affected by the law.

1.97 The committee draws its scrutiny concerns to the attention of senators and leaves to the Senate as a whole the appropriateness of incorporating material that may not be freely and readily available to all those interested in the law.

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[84] Schedule 2, item 2. The committee draws senators’ attention to this provision pursuant to Senate Standing Order 24(1)(a)(v).

[85] Explanatory memorandum, p. 18.

[86] Explanatory memorandum, p. 17.

[87] Explanatory memorandum, p. 18.