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Recommendations

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# Description
Recommendation 1 The objects clause (section 2A) in the Narcotic Drugs Act 1967 be amended to include a statement along the lines that an object of the Narcotic Drugs Act 1967 is to enable cannabis cultivation, production, manufacture and research, in order to ensure that medicinal cannabis products are available to Australian patients for therapeutic purposes.
Recommendation 2 The Narcotic Drugs Regulation 2016 be amended by deleting paragraph 4A(b) (specifically 'cannabidiol (including all isomers and salts)').
Recommendation 3 The Narcotic Drugs Act 1967 be amended by deleting paragraph (b) from the definition of 'cannabis plant' in section 4(1) of the Narcotic Drugs Act 1967 (specifically, '(b) any part of a plant of the genus cannabis including, but not limited to, the seeds, stems or leaves of the plant').
Recommendation 4 The Australian Government Department of Health continue to monitor and advise the Australian Government on options (if any) for altering the operation of the Narcotic Drugs Act 1967, consistently with the provisions of the Single Convention, to remove any unintended obstacles to the cultivation and commercial sale of low-THC hemp under State and Territory law.
Recommendation 5

The Office of Drug Control publish more extensive guidance than is currently published on:

  • the meaning of 'manufacture' in the Narcotic Drugs Act 1967
  • the relationship of that term to other relevant terms in the Narcotic Drugs Act 1967 (such as 'cultivation', 'production' and 'research') the comparison between the manufacture licence provisions in the Act and manufacture requirements in the Therapeutic Goods Act 1989 and State and Territory laws
Recommendation 6

The Office of Drug Control consider publishing more extensive guidance than is currently published on:

  • the meaning of the term 'research' in the Narcotic Drugs Act 1967: the activities of a research or product development nature that can be authorised by a medicinal cannabis licence or manufacture licence in the absence of a separate cannabis research licence
Recommendation 7 The Narcotic Drugs Act 1967 be amended to establish a new licence structure applying to medicinal cannabis products. The Narcotic Drugs Act 1967 should provide for the issue of a single licence to authorise all or some of cultivation, production, manufacture and research of such products.
Recommendation 8

The requirements imposed by the Narcotic Drugs Regulation 2016 on licence and permit applicants to provide information and documents in support of applications be revised, with the following objectives:

  • to delete requirements that are no longer necessary to attaining the objectives of the licensing or permit decision
  • to merge or consolidate requirements that are similar in nature, so as to reduce the number of separate requirements that applicants are required to meet
  • to reduce the number and breadth of mandatory requirements imposed on applicants
  • to frame the requirements in more general terms that can, in appropriate circumstances, be elaborated in guidelines issued by the Australian Minister of Health under section 26C(1) of the Narcotic Drugs Act 1967 or in informal guidance published by the Office of Drug Control
Recommendation 9 The Narcotic Drugs Act 1967 be amended by repealing section 11K, on the basis that it imposes an unnecessary and counterproductive constraint on the permitted uses of medicinal cannabis products that are manufactured pursuant to licences under the Narcotic Drugs Act 1967.
Recommendation 10

The Narcotic Drugs Act 1967 be amended to provide:

  • a medicinal cannabis licence, cannabis research licence or manufacture licence applying to cannabis products shall be granted for a term of maximum term of five years
  • a licence holder may apply for renewal of the licence at the expiration of the licence term, in accordance with the Narcotic Drugs Regulation 2016
  • the renewal of the licence may be refused on a ground on which the Secretary must or may revoke a licence
Recommendation 11 The information and document requirements in the Narcotic Drugs Regulation 2016 applying to an application for a medicinal cannabis permit, cannabis research permit or manufacture permit be reviewed to reduce the level of detail and specificity required in applications, as part of the review proposed in Recommendation 8 to reduce the detailed prescriptive requirements in the Regulation.
Recommendation 12

The Narcotic Drugs Act 1967 (sections 10M, 10N, 13, 13A) and the Narcotic Drug Regulation 2016 be amended to provide:

  • that a licence holder must obtain the formal written approval of the Secretary for a variation of a permit, if the variation is of a kind listed in the Regulation
  • as to any other variation of a permit that is not listed in the Regulation as one that requires the Secretary's written approval - the licence holder shall notify the variation to the Secretary before acting on the basis of the variation
Recommendation 13 The Office of Drug Control review the standard licence conditions that are imposed on medicinal cannabis, cannabis research and manufacture licences, to ensure that conditions are not imposed unnecessarily and that conditions are appropriately framed.
Recommendation 14

The Narcotic Drugs Regulation 2016, regulations 18 and 39 be amended:

  • to delete the condition that a licence holder take reasonable steps not to employ a person who has sought treatment for drug addiction
  • to amend the condition that a licence holder take reasonable steps not to employ a person who has used illicit drugs during the previous five years, by providing instead (in terms similar to sections 8H and 9G of the Narcotic Drugs Act 1967) that the Secretary may excuse reliance on that condition if the licence holder has taken reasonable steps to ascertain drug usage by employees and has disclosed any relevant knowledge to the Office of Drug Control
Recommendation 15 Sections 8M(e), 9L(e) and 11N(e) of the Narcotic Drugs Act 1967 be amended to require that a licence specify the persons who are required by the Narcotic Drugs Regulation 2016 to be specified as persons who can engage in activities authorised by the licence.
Recommendation 16 The Office of Drug Control include guidance on the operation of the notification requirements in sections 10K and 12N of the Narcotic Drugs Act 1967, when undertaking a review of the ODC publication, Guidance: Compliance, Enforcement and Inspections, as proposed in Recommendation 20.
Recommendation 17 The Office of Drug Control take account of the best practice principles on coercive information gathering powers published by the Administrative Review Council, when undertaking a review of the ODC publication, Guidance: Compliance, Enforcement and Inspections, as proposed in Recommendation 20.
Recommendation 18

The Office of Drug Control initiate discussion with Commonwealth, State and Territory law enforcement agencies:

  • to ensure there is a shared understanding of the protections in the Narcotic Drugs Act 1967 for sensitive law enforcement information
  • to ascertain if there is a need for an administrative protocol regarding the operation of those protections, especially as they apply to sensitive law enforcement information that may be provided to the Administrative Appeals Tribunal in proceedings before the Tribunal for the review of a decision under the Narcotic Drugs Act 1967
Recommendation 19 Sections 10P and 13B of the Narcotic Drugs Act 1967 be amended to provide that the relationship between a business associate and a licence holder is a discretionary ground for the revocation of a licence (subsections 10P(2) and 13B(2)) and not a mandatory ground for revocation (subsections 10P(1) and 13B(1)).
Recommendation 20 The Office of Drug Control review its publication, Guidance: Compliance, Enforcement and Inspections, with a view to developing and publishing more comprehensive and contemporary regulatory guidance. Public consultation be a part of this review.
Recommendation 21 The Office of Drug Control review the information presented on its website to evaluate if further helpful information or links can suitably be provided on the interaction of the medicinal cannabis scheme in the Narcotic Drugs Act 1967 with relevant Commonwealth, State and Territory laws. This review be undertaken in consultation with the Australian Advisory Council on the Medicinal Use of Cannabis and the three intergovernmental Working Groups.
Recommendation 22 The Australian Government Department of Health arrange for the interaction of the Narcotic Drugs Act 1967 and other relevant Commonwealth, State and Territory laws relating to cannabis to be a standing agenda item in the meetings of the Australian Advisory Council on the Medicinal Use of Cannabis and the three intergovernmental Working Groups.
Recommendation 23 Section 25A of the Narcotic Drugs Act 1967 be repealed if, at the expiration of current approvals under the section, it becomes a spent provision that is no longer required.
Recommendation 24 The Office of Drug Control develop a risk management framework dealing with the exercise of its regulatory functions, drawing from the Commonwealth Risk Management Policy and the Australian Standard, Risk Management - Guidelines.
Recommendation 25 The Office of Drug Control review its administrative procedures to identify changes that can be implemented to provide an enhanced level of client service to existing licence holders.
Recommendation 26 The Office of Drug Control undertake a review, every six months, of a sample of notices issued during the previous six months under section 14J of the Narcotic Drugs Act 1967 requiring the provision of specified information, to evaluate the Office of Drug Control's reliance on section 14J and the quality of section 14J notices. The review include participation of at least one independent representative from elsewhere in the Australian Government Department of Health or another Commonwealth agency.