Therapeutic Goods Order No 93 (Standard for Medicinal Cannabis) [F2017L00286]-Advice only [2017] AUSStaCSDLM 157 (5 October 2017)

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Instrument	Therapeutic Goods Order No. 93 (Standard for Medicinal Cannabis) [F2017L00286]
Purpose	Establishes a standard for medicinal cannabis products, in the absence of any current international quality standard applying to medicinal cannabis products
Authorising legislation	Therapeutic Goods Act 1989
Department	Health
Disallowance	15 sitting days after tabling (tabled Senate 28 March 2017) Notice of motion to disallow must be given by 9 August 2017
Scrutiny principle	Standing Order 23(3)(a)

Access to incorporated document

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 Therapeutic Goods Order No. 93 (Standard for Medicinal Cannabis) [F2017L00286] (the instrument) incorporates the European Pharmacopoeia as in force from time to time. However, the ES states:

The European Pharmacopoeia is available online at: http://online.pheur.org. At the time of making this Order, it is understood that a subscription fee is required to access the current edition of this publication. It is expected that manufacturers of medicinal cannabis products acquire access to the European Pharmacopoeia as part of an overall understanding of, and compliance with the regulatory regime for medicinal cannabis products. Further, versions of this publication may be available through libraries.

The committee acknowledges that anticipated users of the instrument would have access to the incorporated document. However, in addition to access for manufacturers of medicinal cannabis products 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.

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.^[1] 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.

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] Thirty-Ninth Parliament, Report 84, Joint Standing Committee on Delegated Legislation, Access to Australian Standards Adopted in Delegated Legislation (June 2016) http://www .parliament.wa.gov.au/parliament/commit.nsf/all/6BCDA79F24A4225648257E3C001DB33F?opendocument&tab=tab3 (accessed 2 March 2017).