Therapeutic Goods (Permissible Ingredients) Determination No 1 of 2017 [F2017L00079]-Advice only [2017] AUSStaCSDLM 67 (15 February 2017)

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Instrument	Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2017 [F2017L00079]
Purpose	Revokes the Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016 (as amended), and has the effect of permitting the ingredients described in the Determination, subject to the requirements described in the Determination for an ingredient, to be contained in medicines or to be listed on the Australian Register of Therapeutic Goods
Last day to disallow	9 May 2017
Authorising legislation	Therapeutic Goods Act 1989
Department	Health
Scrutiny principle	Standing Order 23(3)(a)

Access to incorporated documents

The committee previously accepted an undertaking by the Minister for Health

to specify in the next edition of the permissible ingredients determination where incorporated documents can be freely obtained.^[1] Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2017 [F2017L00079] (the determination) is the next edition.

Paragraph 15J(2)(c) of the Legislation Act 2003 requires the ES for a legislative instrument that incorporates a document to contain a description of that document and indicate how it may be obtained.

The committee's expectations where a legislative instrument incorporates a document generally accord with the approach of the Senate Standing Committee for the Scrutiny of Bills, which has consistently drawn attention to legislation that incorporates documents not readily and freely available (i.e. without cost) to the public. Generally, the committee will be concerned where incorporated documents are not publicly and freely available, because persons interested in or affected by the law may have inadequate access to its terms.

With reference to the above, the committee notes that the determination incorporates:

• British Pharmacopoeia (BP);

• European Pharmacopoeia (EP);

• United States Pharmacopeia – National Formulary (USP-NF); and

• Food Chemicals Codex (FCC) published by the United States Pharmacopeial Convention.

While the committee notes that the ES is generally helpful in providing information about where documents incorporated in the determination can be obtained, in relation to the above documents, the ES states:

A fee is required for access to these documents. It is anticipated that a sponsor of a medicine included in the Australian Register of Therapeutic Goods and other interested persons in the medicines industry using this instrument would be in possession of these standards in order to manufacture the medicine or use the ingredients. Further, versions of these documents are available through a number of libraries allowing public access.

The committee acknowledges that anticipated users and other interested persons

in the medicines industry using this determination would be in possession of the incorporated documents. However, in addition to access for members of the medicines industry, the committee is interested in the broader issue of access for other parties who might be affected by, or are otherwise interested in, the law.

In this respect, the committee notes the advice in the ES that the incorporated documents are available through a number of libraries allowing public access.

The committee's expectations in this regard are set out in the guideline on incorporation contained in Appendix 1.

The committee draws the above to the minister's attention.

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[1] See Delegated legislation monitor 10 of 2016, p. 51.