Chapter 4: Overview of the Act and the key issues

This chapter covers three topics:

• The first part explains the medicinal cannabis scheme that was introduced into the ND Act in 2016. The focus of discussion is the new licensing and permit provisions that were designed to balance several objectives of the new scheme, and the activities involving cannabis to which the scheme applies.

  A more detailed discussion of the licensing and permit provisions occurs in Chapter 6, where it is recommended that a new licensing approach be adopted based around a single licence that would authorise some or all activities regulated by the ND Act. Key terms that are used in the licensing provisions (such as 'cannabis', 'cultivation', 'research' and 'manufacture') are discussed in Chapter 5. The mechanisms in the ND Act for enforcing compliance with licence and permit conditions and requirements are discussed in Chapter 7.

• The Discussion Paper that formed part of this Review identified six Key Themes on which submissions were invited. A summary of the submissions is given in this third part of the chapter. The discussion overlaps with that of other chapters, but also presents a larger-scale picture of the views expressed in submissions.
• The fourth part of the chapter recommends that the ND Act include a clearer statement of the objects of the medicinal cannabis scheme.

Prior to the enactment of a medicinal cannabis scheme within the ND Act in 2016,[69] the ND Act contained a basic framework for regulating narcotic drugs, in two ways. The Minister could grant an applicant a licence to manufacture narcotic drugs, provided this would be consistent with Australia's obligations under the Single Convention.[70] There were allied powers in the ND Act to grant manufacturing permits, inspect licensed premises, give directions to licensees, and to make it an offence to manufacture narcotic drugs except as authorised by a licence under the ND Act. The second way the ND Act regulated narcotic drugs was to regulate the movement of drugs through Australia (for example, on vessels).[71]

The medicinal cannabis scheme retained and built on the existing features of the ND Act, but overall was more extensive and far reaching. Some parts of the amended ND Act (such as some licensing provisions) apply only to cannabis regulation. Other parts (such as monitoring and enforcement powers) apply generally to narcotic drugs but are more detailed to reflect the greater regulatory role the Commonwealth would thereafter play as a result of the ND Act including a new medicinal cannabis scheme.

The medicinal cannabis scheme was designed to implement and strike a balance between several objectives:

• facilitating the cultivation and manufacture of medicinal cannabis products in Australia for supply to patients through approved access and authorised prescriber mechanisms
• supporting Australian research into cannabis cultivation for medicinal use and registration of medicinal cannabis products
• facilitating cooperation between Commonwealth, State and Territory authorities to develop a safe, legal and sustainable supply of cannabis for medical and research purposes
• protecting the community against the diversion to illegal purposes of cannabis products that are locally cultivated and manufactured
• implementing Australia's obligations under the Single Convention.

The medicinal cannabis scheme is framed around a licensing and permit scheme to regulate cannabis cultivation, production and manufacture for medicinal and scientific purposes.

The licensing and permit scheme

Three different licences can be granted under the ND Act:

1. Medicinal cannabis licence:[72] This licence can variously authorise, for medicinal purposes,[73] the cultivation (or growing) of cannabis plants, the production (or separation) of the cannabis flower or plant resin, and associated activities such as obtaining a cannabis plant, storage, packaging, transport and disposal of cannabis product. A single licence can apply to all or some only of those activities. A licence can be granted to an applicant who has not yet established a growing facility.
2. Cannabis research licence:[74] This licence can authorise the same range of cultivation, production and associated activities, for research relating to medicinal cannabis; and can be granted to an applicant prior to research commencing. A cannabis research licence may only authorise cultivation or production for research purposes.[75]
3. Manufacture licence:[76] This licence can authorise the manufacture of a drug, including a drug that is a medicinal cannabis product.[77] A licence to manufacture a drug that includes any part of the cannabis plant cannot be granted unless the Secretary is satisfied that the intended use of the drug is for research relating to medicinal cannabis products, for use in a clinical trial, or for patient supply or as a registered good in accordance with the TG Act.[78] A manufacturer may require both a manufacture licence under the ND Act and a manufacturing licence under the TG Act if the drug is for human use. The broad difference is that the ND Act licence will control the type and quantity of a drug obtained from a cannabis plant and held by the manufacturer, while the TG Act licence will control the quality, safety and efficacy of the manufactured drug.

A licence holder cannot commence activity under the licence until the licensee has been granted a permit to engage in cultivation, production, research or manufacture. These are correspondingly described in the ND Act as a 'medicinal cannabis permit', 'cannabis research permit' and 'manufacture permit'.[79]

Licences and permits are interrelated, and both are required before any cultivation, production, research or manufacture can be undertaken. They can be granted separately or together, though only a licence holder can apply for a permit. A medicinal cannabis licence will specify matters such as the name of the licence holder, the activities that are authorised by the licence in accordance with a permit, the premises at which cultivation or production or other activities can be undertaken, and the persons authorised to undertake those activities.[80] A medicinal cannabis permit will specify matters such as the types and strands of cannabis plant that may be cultivated, the number of cannabis plants a licence holder can possess, the quantities of cannabis and cannabis resin that can be cultivated and produced and the period during which cannabis plants may be cultivated.[81] There are corresponding provisions for cannabis research licences and permits and manufacture licences and permits.[82]

A licence holder may require multiple permits to undertake the proposed range of cultivation, production, research or manufacturing activities under the licence. Equally, separate permits can be required for each supply chain arrangement.

The ND Act requires that licences and permits specify the period in which they are in force[83] - though the ND Act does not provide guidance as to the minimum or maximum term of a licence or permit. There is no procedure in the ND Act for renewal of existing licences or permits - either a fresh application is required, or the period of the licence can be extended by a variation of the existing licence or permit.

A licence cannot be transferred to another person.[84] This means that a fresh licence application may be required if there is a corporate takeover or restructure.

A licence or permit may be varied, either on application by the licence holder or on the Secretary's initiative.[85] Variations that can be made include the variation or removal of an existing licence condition, imposition of a new condition, and variation of the activities or persons authorised by a licence. For example, a licence holder may apply for a licence variation to the proposed scope or site of a cultivation or production operation; and for a permit variation because planting occurred later than planned. The variation power was used late in 2018 to extend the term of all existing licences for one year.

Requirements to be granted a licence or permit

The requirements an applicant must meet to be granted a licence or permit are spelt out in both the ND Act and the ND Regulation. The requirements are framed in similar terms for all licences and permits, with some contextual variations.

A licence cannot be granted unless the decision maker is satisfied on reasonable grounds of the following matters (among others):[86]

• the applicant is a fit and proper person to hold the licence or permit
• each of the applicant's business associates in relation to the application is a fit and proper person to be associated with a licence or permit holder
• the applicant (or, if it is a body corporate, its directors) has not engaged in conduct that constitutes a serious criminal offence in the previous ten years
• the grant of the licence or permit would not be inconsistent with Australia's Single Convention obligations
• the applicant will take reasonable measures to ensure the physical security of all cannabis products being handled by the applicant
• the proposed location, facility and security arrangements are suitable.

Three key terms in those requirements are discussed in Chapter 5 - 'fit and proper person', 'business associate' and 'serious criminal offence'. The information and documents an applicant must provide are discussed in Chapter 6.

In deciding a licence application the decision maker may also have regard to any other matter considered relevant, including matters that relate to the activities to be undertaken under the licence.[87]

A change in circumstances may trigger a need to re-visit the licensing requirements during the currency of a licence - for example, if there is a business restructure of a licensee, or a new issue arising as to the fitness and propriety of a licensee or business associate. As noted in Chapter 7, a standard condition imposed by the ND Act on all licences is a notification requirement about such matters.

The requirements applying to permit applications are comparatively limited, as permits can be granted only to licence holders.[88] The main requirements are:

• a permit application must relate to an activity that is authorised by the licence
• an application may be refused if the applicant has breached a licence condition
• an application must be refused if the decision maker is not satisfied that any standards issued by the Minister under the ND Act[89] have been or will be met.

Special licensing requirements

There are special requirements that apply separately to each category of licence application.

As to a medicinal cannabis licence application, there must be what is colloquially described as a 'demonstrated supply arrangement' between the licence applicant and a licensed producer or manufacturer. Specifically: 

• A licence for the cultivation only of cannabis plants cannot be granted unless the decision maker is satisfied on reasonable grounds that the cultivated plant will be supplied to a licence holder for production.[90] Correspondingly, the ND Act imposes a licence condition that a contract is in existence with a licence holder who is authorised to undertake production.[91]
• A licence to produce cannabis or cannabis resin cannot be granted unless the decision maker is satisfied on reasonable grounds that the applicant holds a manufacture licence or the cannabis product is to be supplied to a manufacture licence holder either to manufacture a medicinal cannabis product or for research relating to such products.[92] Correspondingly, the ND Act imposes a licence condition that a contract is in existence with a manufacture licence holder relating to those purposes.[93]

As to a cannabis research licence application, any cultivation or production that is permitted by the licence must be for the purposes of research relating to medicinal cannabis.[94]

As to a manufacture licence application to authorise the manufacture of a drug that is derived from the cannabis plant, the intended use of the drug must be for any one of the following:

• for use in research relating to medicinal cannabis products
• for use in a clinical trial conducted in accordance with the TG Act
• as a medicinal cannabis product that will be supplied in accordance with an approval or authority under the TG Act
• as a medicinal cannabis product that is a registered good under the TG Act
• by a pharmacist in a public hospital in accordance with the TG Act
• for export as approved under the Customs Export Regulations
• for manufacture in accordance with the TG Act for one of the foregoing uses.[95]

Interaction of the ND Act and the Criminal Code

The ND Act has a limited sphere of operation in relation to cannabis. The activities that can be licensed under the ND Act (cultivation, production, research and manufacture) must relate to the use of cannabis for a medicinal or research purpose.[96] The term 'medicinal cannabis product' is defined in the ND Act as meaning a product (including a substance, composition, preparation or mixture) that is wholly or partly derived from the cannabis plant and is used 'for the purposes of curing, or alleviating the symptoms of, a disease, ailment or injury'.[97]

The use of a cannabis plant for a non-therapeutic purpose - such as an industrial or horticultural purpose - is not controlled by the ND Act. The relevant offence provisions in the ND Act apply only to the conduct of licence holders, in undertaking cultivation, production or manufacture that is not authorised by their ND Act licence.[98]

The Commonwealth Criminal Code applies more generally to the cultivation of cannabis plants and the manufacture of controlled drugs derived from cannabis, cannabis resin or THC.[99] It is an offence under the Code to undertake those activities unless the cultivation or manufacture is justified or excused by a Commonwealth, State or Territory law.[100] However, the Code, too, has a limited sphere of operation, in two respects: it does not apply to cannabidiol, which does not fall within the definition of 'controlled drug'; and the Code only applies to cultivation or manufacture of commercial, marketable or trafficable quantities above a specified weight or number of plants.

Two points can be drawn from that legislative framework. The first is that it may be necessary to consult the ND Act, the Code and State/Territory law to ascertain the applicable rules regarding cultivation, production, research or manufacture relating to a cannabis plant. The second is that the particular activity may not be covered by a Commonwealth law and may be regulated only by a State or Territory law. An example would be some activities relating to industrial or low-THC hemp.

A major focus of the public consultation for this Review, noted in Chapter 1, was discussion of six Key Themes regarding the terms and operation of the ND Act. Many submissions were tailored to those themes and expressed views directly on each theme.

Following is a summary of those responses. The individual submissions are not quoted or referred to, as this summary is designed to synthesise the diverse views expressed in submissions, and some submissions requested non-publication of either the author's details, or the specific content of the submission.

It is important to stress that the following summary does not evaluate or endorse the views expressed in submissions. Later chapters of this report contain findings and recommendations.

1. Does the Narcotic Drugs Act 1967 establish a suitable framework for ensuring a sustainable supply of safe medicinal cannabis products for therapeutic purposes?

The submissions generally acknowledged that the ND Act was designed to implement the Single Convention and was appropriately framed as a licensing scheme that tightly regulated cannabis production and supply for therapeutic purposes. It was acknowledged too that the ND Act had made a large difference in stimulating development of a vigorous domestic industry, particularly in the fields of cultivation, production and research.

There was, on the other hand, a strong view that the new medicinal cannabis scheme - in the first two years of operation - had not fulfilled the expectation of making medicinal cannabis more readily and easily available to Australian patients. The limited number of patients who are receiving prescribed medicinal cannabis are obtaining it from imported sources and not from Australian production and manufacture. The cost of medicinal cannabis products is high and unaffordable for many patients, and the procedure to obtain a prescription can be complex and time-consuming. There is an uneven pattern of prescriptions around Australia.

It was said to be easier for many people to obtain a cannabis product through illicit channels, and they are following that path. This exposes them to legal action and to obtaining a medicinal product that may be unsafe or ineffective. Higher numbers of patients have lawfully obtained medicinal cannabis in countries such as Canada, the Netherlands and Germany, which have different schemes that have been in place for many years.

There was also a strong view that the requirements of the ND Act and its administration had hampered the development of a vibrant local industry that could support a sustainable supply channel of affordable and effective cannabis medicines. A paramount problem, noted below, is said to be the regulatory focus - or overemphasis - on security and integrity vetting to combat potential criminal risks of infiltration and cannabis products being diverted to illicit use. Under-resourcing of administration of the new scheme by the ODC was also nominated as a major contributory factor in delay and inefficiency at the administrative level.

Many suggestions were made to correct the supposed failure of the new scheme to meet the needs of patients - ranging from adopting an entirely different framework for cannabis regulation, to improving and streamlining the present scheme. Prominent suggestions for targeted reform include the introduction of a simpler licensing and permit scheme, and expansion of the objects clause in the ND Act to spell out the aim of ensuring there is a sustainable supply of medicinal cannabis products to Australian patients.

Another recurring theme in many submissions was a claim that the ND Act is at odds with the spirit of the Single Convention in preventing full use of industrial hemp/low-THC products that are subject to State/Territory regulation. This has implications for the commercial health of that industry, as well as its ability to make non-medicinal cannabidiol products available to Australian consumers. It was said that the need to resolve this overlap will become more pressing if current proposals to reschedule cannabis products in the Single Convention are adopted by the United Nations Commission on Drugs.

1. Does the Narcotic Drugs Act 1967 establish a suitable framework for ensuring the availability of cannabis products for research purposes?

The submissions noted that the ND Act supports research, and this has been reinforced at the administrative level. Notably, research licence and permit requirements are less onerous, licensing decisions can be made reasonably quickly, and lower licence fees apply. A strong research culture is developing in Australia.

It was felt, nevertheless, that research was being held back by current arrangements. A central problem was said to be that the requirement for a separate cannabis research licence can hamper normal research and development activity under other licences. This is regarded as incongruous, given that stricter security and fitness requirements may have been met to obtain the cultivation or manufacturing licence.

The obligation on license holders to forecast specifically the composition of an end product in production and manufacturing was criticised as constricting and inhibiting innovation and strain development. There has been a reluctance in Australia to accept international trial data to support product development.

Collaboration between licence holders and research institutions can also be hampered by restrictions on the transfer or supply of cannabis product from one licensee to another. These restrictions apply variously to the quantity of cannabis product that can be transferred to a research entity, the permission required to undertake the transfer and the detailed information to be provided to obtain permission.

There is also uncertainty for research licence holders as to what activities are permitted under a licence. Questions have arisen about the scope of authority for activities such as training, analytical testing, validation and combined research projects.

1. Does the Narcotic Drugs Act 1967 establish a suitable framework for preventing the diversion of controlled narcotics to illegal uses?

The submissions accepted that the Single Convention and the ND Act require a strong regulatory focus on preventing the diversion of controlled narcotics to illegal uses. This focus was understandably paramount when the scheme was being established because of the improbabilities faced in regulating a new industry that is handling a narcotic drug.

A qualifying view was that the diversion risks had been overstated, or at least that a singular emphasis on this issue has been undiminished since the early days of the medicinal cannabis scheme.

Submissions argued that insufficient weight was being given to how diversion risks were lessened by existing Commonwealth, State and Territory legislation relating to cannabis. It was also in the commercial self-interest of the medicinal cannabis industry to guard against illicit diversion and to manage risks effectively, in order to safeguard the integrity of the industry. It was noted too that the diversion risks did not apply to CBD which was non-psychoactive.

The strong focus given to the risk of diversion was felt in other ways. For example, the licensing application questions asked by the ODC included questions relating to commercial risk or judgement that should more appropriately be the concern of the applicant rather than the regulator. It seemed too that the bar had been raised for newer applicants, as ODC requirements became more demanding based on experience gleaned from processing earlier applications.

Another view was that an overemphasis on risk diversion could have the counterproductive effect of stifling the legitimate medicinal cannabis industry and opening an avenue for illegitimate production.

1. Has the Commonwealth (and in particular the Office of Drug Control) implemented an efficient and effective regulatory scheme for medicinal cannabis? Is an appropriate and proportionate regulatory burden imposed on those applying for or holding licences and permits? As to medicinal cannabis licences, is there duplication in the processes and information required in applying for a licence and a permit?

The submissions acknowledged that the ODC had not been properly resourced to deal with the unexpectedly large number of licence applications it initially received and that had not abated. Several submissions complimented the ODC for the professional way it grappled with the challenges and consulted constructively with applicants and other stakeholders.

While submissions recognised the challenges facing the ODC, they made similar criticisms of how effectively the medicinal cannabis scheme was operating, including:

• delay in processing licence and permit applications
• uncertainty facing applicants as to the information to be provided in initial applications
• multiple ODC requests under s 14J of the ND Act that appeared to be unnecessary or to duplicate other requests
• inconsistent s 14J requests from two sections within the ODC
• inefficiency arising from different ODC staff dealing with an application at different stages
• more detailed information being required for permit applications than seemed warranted
• lack of visibility by applicants as to the processing stage their application had reached
• having to provide information for a new licence application that had earlier been provided
• existing licence holders not being given priority when lodging permit or licence variation applications.

Similar suggestions were made in many of the submissions to address those issues. The suggestions included:

• giving priority to applications from existing license holders, particularly for permit applications and variations
• allocating a case manager or liaison officer to applicants
• building an online portal through which information can be lodged, stored, retrieved, varied, checked and notified
• providing more extensive published guidance for initial applications
• screening/triaging initial applications for gaps and weaknesses
• cross-referencing s 14J requests to the legislative standards
• introducing indicative timeframes for decision-making.

The sharpest theme across the submissions was that either different or preferential processes should be adopted for existing license holders. It was submitted that if a licence holder has an unblemished regulatory record, greater confidence can be placed on their reliability in subsequent applications and dealings. Appropriately realistic risk management approaches that could be adopted include:

• allowing a licence holder to notify a change rather than seek a permit variation
• imposing more flexible licence and permit conditions that preclude the need for unnecessary variation applications
• allowing licence holders to notify compliance, risk and breach issues in periodic reports rather than contemporaneously
• adopting standard monitoring of the performance of licence holders
• doing occasional spot checks.

Some submissions emphasised those points by drawing a comparison with what was said to be the more streamlined and effective regulatory approaches adopted by the TGA.

1. Has an appropriate compliance and enforcement regime been implemented, both in the Narcotic Drugs Act and administratively? Are risks being appropriately managed? Is there excessive risk aversion?

The submissions on this theme echoed similar points as above. It was acknowledged that a strong compliance focus had been adopted in line with the Single Convention and to ensure that a trusted and respected medicinal cannabis industry would develop in Australia. It was also seen to be important that new licence applicants are required to demonstrate in their initial licence applications that they can meet a high industry standard.

On the other hand, some submissions argued that the administration of the medicinal cannabis scheme was coloured by excessive risk aversion, particularly now that the scheme is established and functioning. This was said to be a contributing factor to the administrative delays that have bedevilled the scheme. It is also said to be inhibiting the development of the industrial hemp/low-THC industry by imposing ND Act requirements on production occurring at the boundary of the regulated industry.

One example (noted above) given of the risk averse focus is that a suitable risk management strategy has not been implemented with respect to existing licence holders who have an unblemished regulatory record. Some felt there was insufficient recognition of an established licence holder's own commitment to and commercial self-interest in strong compliance.

There was also said to be too much attention given during the initial licensing phase to the fine detail of an applicant's proposed operating procedures. This can stifle innovation and continuous improvement, and gives insufficient weight to other processes, such as an applicant's own quality management and reporting obligations and the regulator's audit and inspection powers.

Examples were given of standards or conditions that were thought to be unnecessarily strict. One example was the condition imposed by the ND Regulation that a licence holder not employ a person who has during the previous five years used illicit drugs.[101] This is stricter than the requirement of the ND Act that the criminal record of an applicant or business associate is simply a matter to which the Secretary can have regard at the licensing stage.[102] Another example was the requirement of the ND Act that a licence specify the persons authorised to engage in activities under the licence, which could require a licence variation upon the departure or arrival of a new senior employee.

Finally, it was submitted that the strong focus given to criminal risks of diversion and infiltration had overshadowed competing risks that fall within the objects of the medicinal cannabis scheme. One such risk is that patients will be disadvantaged if the supply pathways for medicinal cannabis are too complicated or rigid, or they may instead opt to source cannabis of untested efficacy from illicit sources.

1. Does the ND Act interact suitably with other Commonwealth, State and Territory laws relating to the regulation of cannabis products and narcotic drugs? Are the intersection points clear? Is there evidence of duplication?

It was noted in submissions that the regulatory framework is complex because of multiple Commonwealth, State and Territory laws and agencies. The submissions acknowledged that this was partly unavoidable because of both the constitutional division of government responsibilities and the overlap in activities that were subject to regulation. Examples given were the overlap between the ND Act and other Commonwealth laws relating to the manufacture of therapeutic goods and the import and export of narcotic drugs, and the overlap between the ND Act and State and Territory laws relating to the hemp industry, access to medicines and regulation of industrial premises.

While accepting this complexity, the submissions proposed that some matters warranted further attention. One is the importance in administering the ND Act of giving appropriate recognition to State and Territory laws that combat criminal risks in relation to manufacture, storage, testing and transport of narcotic drugs. Doing so could reduce the excessive risk aversion that has been criticised in the administration of the medicinal cannabis scheme.

A second is the need for government agencies at all levels to look for ways of reducing the complexity for industry participants, the medical profession and patients. An example that was commended was the introduction in 2018 of a system for online lodgement of single SAS applications to meet relevant Commonwealth, State and Territory requirements.

Contrasting examples were given of areas where jurisdictional integration has been lacking. For example, a person or entity in one jurisdiction who has specialist qualifications or a licensing permission that authorises activities that are cannabis-related, might not have reciprocal recognition in other jurisdictions.

It was felt that more could be done in Australia to monitor the conflict points and uncertainties in the overall regulatory framework and to look for ways of streamlining regulatory requirements. At present it was largely left to industry participants to work their way through the regulatory maze.

The objects of the ND Act

An objects clause was inserted into the ND Act as part of the 2016 amendments. It reads:

2A Object of this Act

The object of this Act is to give effect to certain of Australia's obligations under the Single Convention on Narcotic Drugs 1961, as in force from time to time.

The framing of the objects clause in this way is perhaps understandable but it is not informative. It says nothing directly about the policy intention of the new medicinal cannabis scheme that was the purpose of the 2016 amendments. The structure and text of the amended ND Act, viewed alone, convey the sense that the singular concern is industry regulation with an emphasis on strict regulatory compliance.

A contrast can be drawn with government statements that accompanied the introduction of the 2016 amendments. The opening paragraph of the Explanatory Memorandum leads with a reference to patient need:

The Narcotic Drugs Amendment Bill 2016 will provide a legislative framework that will enable cannabis cultivation in Australia and provide Australian patients in need with access to medicinal cannabis for therapeutic purposes. These amendments will also ensure that when cultivation and production of cannabis and manufacture of cannabis for medicinal purposes begin, Australia will remain compliant with its international treaty obligations as defined in the United Nations Single Convention on Narcotic Drugs, 1961.[103]

The Regulation Impact Statement that was part of the Explanatory Memorandum also gave prominent attention to patient need, as illustrated by the following:

Section 1: The problem to be addressed

There are community expectations that there should be a licit source of cannabis for medicinal use. The fact that there is illicit cannabis for medicinal purposes is concerning as there are no controls on quality or strength nor is there a prescribing service that is professionally based, nor any system for tracking clinical outcomes, including adverse events. This could expose the community to potentially dangerous substances and outcomes.

... Subject to appropriate safeguards, failure to enable supply of cannabis for medicinal purposes, as well as further scientific study into this treatment option, could deny patients access to new, safe and effective medicines and treatments.[104]

There was a similar message in the Minister's Second Reading Speech when introducing the amending Bill:

• The Narcotics Drugs Amendment Bill 2016 provides a clear national licensing scheme allowing the controlled cultivation locally of cannabis for medicinal and scientific purposes.
• Importantly this bill provides the critical 'missing piece' for the Commonwealth to enable a sustainable supply of safe medicinal cannabis products to Australian patients in the future.
• This government understands that there are some Australians suffering from severe medical conditions for which cannabis may have some application, and we want to enable access to the most effective medical treatments available.[105]

A criticism made in several submissions in response to the Key Themes in this Review is that patient need had been overwhelmed by regulatory concerns in the establishment of the medicinal cannabis scheme since 2016. The submissions suggested that an important first step in rectifying this imbalance was to restate clearly that patient need is a core objective of the medicinal cannabis framework established in the ND Act.

That proposal has much to commend it. A statutory objects clause can be important in signifying how an Act should be understood, administered and construed. The clause will be more valuable if it is an identifiable point of reference for the community.

A revised objects clause in the ND Act should not ignore or overshadow the operation of the ND Act in relation to narcotic drugs generally. The ND Act was enacted in 1967 (nearly fifty years before the medicinal cannabis scheme) and had long applied to controlled drugs such as opiates. A revised objects clause should recognise the broader role and operation of the ND Act.

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 Act 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.

• [69] Narcotic Drugs Amendment Act 2016 (Cth).
• [70] ND Act s 9 (prior to 2016 amendments).
• [71] ND Act s 22 (prior to 2016 amendments).
• [72] ND Act s 8E.
• [73] The term 'medicinal cannabis product' is defined in the ND Act s 4(1), and is discussed below under 'Interaction of the ND Act and the Criminal Code'.
• [74] ND Act s 9D.
• [75] ND Act s 9H.
• [76] ND Act s 11G.
• [77] The term 'drug' is defined in the ND Act s 4(1) as including a drug covered by the Single Convention. Section 4(1A) of the Act further provides that, to avoid doubt, the term 'drug' includes 'a medicinal cannabis product that is a drug'. The meaning of 'medicinal cannabis product' is discussed below under 'Interaction of the ND Act and the Criminal Code'.
• [78] ND Act s 11K.
• [79] Respectively, ND Act, ss 8P, 9N and 12.
• [80] ND Act, s 8M.
• [81] ND Act, s 9B.
• [82] ND Act, ss 9L, 10A (research); ss 11N, 12C (manufacture).
• [83] ND Act, ss 8N, 9C (medicinal cannabis licences and permits); ss 9M, 10B (cannabis research licences and permits); ss 11P, 12D (manufacture licences and permits).
• [84] ND Act, s 24C.
• [85] ND Act, s 10M (cannabis licences and permits); s 13 (manufacture licences and permits).
• [86] ND Act, s 8G (medicinal cannabis licence), s 9F (cannabis research licence), s 11J (manufacture licence).
• [87] ND Act, ss 8F(3) (medicinal cannabis licence), 9E(3) (cannabis research licence), 11H(3) (manufacture licence).
• [88] ND Act, ss 8P (medicinal cannabis permit), 9N (cannabis research permit), 12 (manufacture permit).
• [89] ND Act, s 26B.
• [90] ND Act, s 8J(1).
• [91] ND Act, s 10J(1).
• [92] ND Act, s 8J(2).
• [93] ND Act, s 10J(2).
• [94] ND Act, s 9H.
• [95] ND Act, s 11K(2) (as to the first four uses), ND Regulation, reg 37 (as to the latter three uses).
• [96] ND Act, ss 8E, 9D, 11G.
• [97] ND Act, s 4(1).
• [98] ND Act, ss 11B, 13E.
• [99] As to cultivation: Criminal Code ss 303.4, 303.5, 303.6. As to manufacture: ss 305.3, 305.4, 305.5.
• [100] Criminal Code, ss 10.5, 313.1.
• [101] ND Regulation, regs 18(2)(a) and39(2)(a).
• [102] ND Act, ss 8A(a), 8B(a) and 8H.
• [103] Explanatory Memorandum, Narcotic Drugs Amendment Bill 2016, p 1.
• [104] Explanatory Memorandum, Narcotic Drugs Amendment Bill 2016, p 9.
• [105] The Hon Ms Ley, Minister for Health, Second Reading, House of Representatives, Official Hansard, 10 February 2016, p 1164.