Chapter 8: Interaction of the ND Act with other laws

The interaction between the ND Act and other Commonwealth and State and Territory laws was designated as a Key Theme of this Review, as explained in Chapters 1 and 5. The ND Act is one of many Australian laws relating to cannabis, and it has an overlapping operation with other laws dealing with cannabis cultivation, manufacture, research, possession and supply.

Some overlap issues have been discussed in other chapters. This chapter draws that discussion together to highlight that the interaction of the ND Act with other laws is a distinct and important issue and that it warrants active monitoring.

Three dimensions of the topic are covered in this chapter:

• the adequacy of published guidance on the interaction of the ND Act and other laws
• identifying interaction issues that may warrant consideration and action
• ND Act provisions to preserve the operation of State and Territory laws.

The theme of this chapter can be captured in two contrasting observations. One is that participants at all points on the compass - regulators, growers, manufacturers, prescribers, pharmacists and patients - accept that in a complex federal legal setting there will be numerous issues arising as to how different laws interact.

The other observation is that there are common goals in many of the laws; ensuring the laws work well together is therefore important. A goal that has become steadily more prominent in recent years is to ensure that a safe, legal and sustainable supply of cannabis is available within Australia for therapeutic and research purposes. That goal must be balanced with others, notably the goal of protecting the Australian community by ensuring that locally cultivated and manufactured cannabis products are not diverted to illegal purposes.

The community looks to government agencies to provide clear and helpful advice on the laws they administer and their interaction with other laws. People typically turn to an agency's website to find that advice.

The ODC website provides a valuable collection of clear and accessible advice that is earmarked for different groups - cultivators, manufacturers, importers, exporters, travellers, prescribers and patients. The ODC website contains downloadable forms for different licence and import/export processes, a comprehensive and helpful Frequently Asked Questions, operational statistics, the minutes of meetings of the Australian Advisory Council on the Medicinal Use of Cannabis, and links to the advice provided on the websites of other Commonwealth, State and Territory agencies.

There is little said on the ODC website about the operation of relevant State and Territory laws. These are mostly noted in general terms - for example, that a manufacture licence 'is in addition to any licence issued by State or Territory Governments', or that a licence holder's purchase of stock in Australia 'must be consistent with their state/territory licence'.

Links are provided to the health department websites of all States and Territories - though not to specific information pages on three of those websites[233] and two specific advice links were no longer operative.[234] The information pages on some State and Territory websites give a helpful explanation of the concurrent operation of both State and Commonwealth laws.[235]

It is well understood that websites play a vital and central role in the effective administration of any statutory scheme. Websites, however, are not static. The content and presentation will exhibit strengths and weaknesses that are likely to change over time.

On first appearance there is scope to enhance the quality of the ODC website as to the advice it gives about the interaction of the medicinal cannabis scheme in the ND Act with State and Territory laws. Whether specific content changes are required that would fit appropriately with the existing website content and objectives is ultimately a judgement for the ODC to make. The most that need be said in this report is that the ODC should review this issue periodically in consultation with the Australian Advisory Council on the Medicinal Use of Cannabis and the three intergovernmental working groups (Medicinal Cannabis Access Working Group, Cultivation and Production Working Group and Law Enforcement Working Group).

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.

The submissions to this Review gave examples of poor or inefficient interaction of Commonwealth, State and Territory laws relating to cannabis. Some of the examples fall outside the scope of this Review as they do not relate to the operation of the ND Act. A few other examples raise issues larger than the examples themselves and would require more extended consultation and analysis than was appropriate in this Review. A couple of examples are partially addressed by recommendations in other chapters of this report.

The examples raised with this Review are listed below to illustrate that the interaction of the laws in each jurisdiction relating to medicinal cannabis is a lively topic. This underscores the need to ensure there is a proper process in place to maintain a steady focus on the interaction of the ND Act and other laws. A recommendation to that effect is made below after the following summary of examples.

Manufacture licence holders under the ND Act may be subject to other laws relating to manufacturing. One is the TG Act, which requires a licence to manufacture therapeutic goods if the product is intended to be supplied for human use (also called a GMP licence, or good manufacturing process licence).[236] State medicines and poisons laws relating to matters such as site security, storage and transport may also apply.
A view propounded by some commentators is that the ND Act manufacture licence provisions should not apply to cannabis in light of these other laws as those laws have effectively regulated the manufacture of opiates and controlled drugs over many years. A different approach adopted in this report is that the licensing of manufacturing in relation to cannabis should be merged into a new single licence structure (see Recommendation 7).

For the moment, however, it is desirable that more extensive guidance is published by the ODC as to the interaction of the different manufacturing requirements (see Recommendation 5). An added consideration is that there is potential for misunderstanding as to the scope of the ND Act manufacture requirements as they go further than required by Article 29 of the Single Convention.

• A related example was that there is overlap between Commonwealth requirements and State/Territory poisons legislation on matters such as product assays, dissolution tests and stability trials, and the personnel who are qualified to undertake those tasks. Regulation of those processes has been long-established in Australia, and the recent imposition of ND Act requirements applying to cannabis is said to be a source of confusion and conflict.
• A similar suggestion for reducing the rigour and administrative burden of ND Act licensing processes is for more recognition to be accorded to State and Territory laws and regulatory processes relating to matters such as storage, testing, transport and site security.
• As noted in Chapters 5 and 6, there have been complaints about the application of manufacture licence provisions in the ND Act to low-THC hemp production and export. Recommendation 2 to delete cannabidiol from the definition of 'drug' in the ND Regulation will partly address that complaint.
• The licensing requirements in the ND Act and in State and Territory legislation relating to cultivation and manufacture are similar though differently expressed. The result can be that staff of an entity that meet one licensing requirement (for example, the 'fit and proper person' test in the ND Act) may not be recognised as meeting a similar licensing requirement in another jurisdiction (for example, to be 'suitably qualified' for a particular function). The suggestion is that procedures for reciprocal recognition should be developed.
• There have been calls for regulatory changes that will enable better commercial integration within the Australian cannabis and hemp industries. For example, an entity that is licensed under State/Territory law to cultivate hemp cannot harvest and sell the cannabis flower tops to an ND Act licence holder, without the State licence holder also obtaining an ND Act licence. This is discussed in Chapter 5.
• Recommendation 18 is for the ODC to initiate discussion with Commonwealth, State and Territory law enforcement agencies regarding the legal and administrative protocols applying to the provision of sensitive law information to the ODC.
• A final and specific suggestion was that Commonwealth practice regarding destruction of cannabis substances should align with the requirement in some States and Territories for supervised destruction of Schedule 8 and Schedule 9 substances.[237]

As those examples illustrate, numerous issues will arise as to the interaction of the ND Act with other laws relating to cannabis. There are likely to be as many different perspectives on whether a problem exists and how it should be tackled. The medicinal cannabis scheme can operate more efficiently and effectively if there are semi-formal processes in place to enable those issues to be raised and discussed.

Consultative processes evolve and adapt. Existing consultative mechanisms relating to medicinal cannabis include the Australian Advisory Council on the Medicinal Use of Cannabis, three intergovernmental working groups (Medicinal Cannabis Access Working Group, Cultivation and Production Working Group and Law Enforcement Working Group), and occasional consultation between the department and two non-government bodies (Medicinal Cannabis Industry Australia and Medicinal Cannabis Council Inc.).

Those consultative mechanisms are active and supported by the people, entities and agencies that are involved. The only additional measure that could usefully be added at this stage is to make the interaction of the ND Act with other Australian laws a standing agenda item at meetings of the Advisory Council and the Working Groups. While interaction issues are currently discussed in those forums, a standing agenda item is a common protocol to highlight the importance of a topic and to ensure that it receives separate attention. It can later be removed as a standing agenda item if this status seems unnecessary.

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.

The ND Act declares an intention not to override State and Territory laws except to the extent of any inconsistency.[238] The intention is that the types of State and Territory law referred to in Chapter 2 relating to matters such as medicines, poisons, controlled substances and criminal activity will continue to operate alongside the ND Act.

The main qualification is that the licensing and permit provisions of the ND Act relating to cannabis cultivation, production and research operate to the exclusion of any State or Territory law that establishes similar licensing or permit arrangements or that would prevent a Commonwealth licence holder from taking action under their licence or permit.[239] The intent is that the ND Act establishes a consistent national scheme in line with Australia's Single Convention obligations. However, the operation of a State or Territory law that would be overridden by the ND Act can be preserved by a regulation under the ND Act.[240]

A special feature of the ND Act to preserve State and Territory laws relating to medicinal cannabis is s 25A. It authorises the Secretary to grant an approval to a State or Territory agency to undertake an activity that otherwise requires a licence or permit under the ND Act.[241] Specifically, a State or Territory agency to which a s 25A approval is granted may itself undertake or authorise another person to undertake the cultivation, production or manufacture of cannabis-derived products for medicinal or research purposes. The approval operates to the exclusion of any inconsistent State or Territory law.[242]

A s 25A approval can only be issued if the Secretary is satisfied on reasonable grounds of three matters:

• the proposed State/Territory activity is not inconsistent with Australia's Convention obligations
• the State/Territory agency to which the approval is granted will take all reasonable measures to ensure the physical security of the cannabis-derived products
• appropriate reporting arrangements are in place consistently with Australia's Single Convention reporting obligations.[243]

The s 25A approval mechanism was included in the ND Act against a background of some States having well-advanced plans to make medicinal cannabis products available to patients, and a projected time lag in those products being available from Australian sources under the new Commonwealth licensing system. The Explanatory Memorandum to the Narcotic Drugs Amendment Bill 2016 explained that the intent of s 25A was 'to allow the earliest possible patient access', but 'is not intended to be used on a permanent basis'.^[244] Authorisations were granted to both Victoria and NSW to cultivate cannabis plants and produce cannabis or cannabis resin - in Victoria for medicinal purposes, and in NSW for the purposes of research relating to medicinal cannabis. Victoria was granted a subsequent authorisation to manufacture cannabis extracts for medicinal purposes. The Victorian approval expires in October 2019 and the NSW approval in July 2019 (NSW has applied for a 12 month extension).

It seems likely that s 25A will soon be a spent provision, on the expiration of the current approvals. There is broad acceptance of the ND Act framework for licensing cultivation, research and manufacture. There is also a strong intergovernmental focus upon the effective operation of the patient access pathways described in Chapter 2. It is notable too that Queensland recently repealed the Public Health (Medicinal Cannabis) Act 2016 (Qld) that provided a comprehensive framework for access to medicinal cannabis.

Although s 25A does not have any untoward or obstructive impact on the operation of the medicinal cannabis scheme, it seems appropriate that it be repealed if it becomes a spent provision.

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.

• [233] Australian Capital Territory, Northern Territory and South Australia (June 2019).
• [234] Queensland and Tasmania (June 2019)
• [235] For example, Victoria: www2.health.vic.gov.au/public-health/drugs-and-poisons/medicinal-cannabis/business-industry
• [236] Therapeutic Goods (Manufacturing Principles) Determination 2018, made under the TG Act s 36.
• [237] Eg, Poisons Regulations 2008 (Tas), reg 38(2)(a); Poisons and Therapeutic Goods Regulation 2008 (NSW), reg 125(2)(a).
• [238] ND Act, s 7.
• [239] ND Act, s 7A(1).
• [240] ND Act, s 7A(2).
• [241] ND Act, s 25A.
• [242] ND Act, s 7A(1).
• [243] ND Act, s 25A(1).
• [244] Narcotic Drugs Amendment Bill 2016, 'Explanatory Memorandum', p 97.