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A Bill for an Act to establish the Regulator of Medicinal Cannabis, and for related purposes
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Registered 28 Nov 2014
Introduced Senate 27 Nov 2014

2013‑2014

 

The Parliament of the

Commonwealth of Australia

 

THE SENATE

 

 

 

 

Presented and read a first time

 

 

 

 

 

 

 

Regulator of Medicinal Cannabis Bill 2014

 

No.      , 2014

 

(Senators Di Natale, Macdonald, Leyonhjelm and Urquhart)

 

 

 

A Bill for an Act to establish the Regulator of Medicinal Cannabis, and for related purposes

  

  

  


Contents

Part 1—Preliminary                                                                                                             1

1............ Short title............................................................................................. 1

2............ Commencement................................................................................... 2

3............ Objects of this Act.............................................................................. 2

4............ Simplified outline of this Act.............................................................. 3

5............ Definitions.......................................................................................... 3

6............ Extension to external Territories.......................................................... 6

7............ Act applies only in participating States and Territories........................ 6

8............ Relationship with State and Territory laws.......................................... 6

9............ Act to bind Crown.............................................................................. 6

10.......... Arrangements with participating States and Territories....................... 7

Part 2—Medicinal cannabis                                                                                             8

Division 1—Simplified outline                                                                                  8

11.......... Simplified outline................................................................................ 8

Division 2—Regulated medicinal cannabis products                                   9

12.......... Register of regulated medicinal cannabis products.............................. 9

13.......... Registration......................................................................................... 9

14.......... Removal or variation of entries in the register of regulated medicinal cannabis        10

15.......... Cannabis products............................................................................. 10

Division 3—Medicinal cannabis licensing scheme                                       11

16.......... Medicinal cannabis licensing scheme................................................ 11

17.......... Offence of failing to comply with a condition of a medicinal licence 12

18.......... Register of medicinal licences........................................................... 12

Division 4—Authorised patients and carers scheme                                  13

19.......... Authorised patients and carers scheme.............................................. 13

Division 5—Experimental cannabis licensing scheme                               14

20.......... Experimental cannabis licensing scheme........................................... 14

21.......... Offence of failing to comply with a condition of an experimental licence 15

22.......... Register of experimental licences...................................................... 15

Division 6—Medicinal cannabis standards                                                     16

23.......... Determination of standards............................................................... 16

Division 7—Import and export licensing scheme                                        18

24.......... Import and export licensing scheme.................................................. 18

25.......... Offence of failing to comply with a condition of an import licence or an export licence           18

26.......... Register of import licences and export licences................................. 19

Part 3—Regulator of Medicinal Cannabis                                                           20

Division 1—Simplified outline                                                                                20

27.......... Simplified outline.............................................................................. 20

Division 2—Establishment, functions and powers of the regulator   21

28.......... Establishment.................................................................................... 21

29.......... Constitution....................................................................................... 21

30.......... Functions and powers....................................................................... 21

31.......... Independence of the regulator........................................................... 23

32.......... Minister may give directions to the regulator.................................... 23

33.......... The regulator has privileges and immunities of the Crown............... 23

Division 3—Appointment of members                                                               24

34.......... Appointment..................................................................................... 24

35.......... Term of appointment......................................................................... 24

36.......... Remuneration and allowances........................................................... 25

37.......... Leave of absence............................................................................... 25

38.......... Outside employment......................................................................... 25

39.......... Disclosure of interests to the Minister............................................... 25

40.......... Other terms and conditions............................................................... 26

41.......... Resignation....................................................................................... 26

42.......... Termination of appointment.............................................................. 26

43.......... Acting appointments......................................................................... 27

Division 4—Procedures of the regulator                                                         28

Subdivision A—Meetings                                                                                       28

44.......... Times and places of meetings............................................................ 28

45.......... Conduct of meetings......................................................................... 28

46.......... Disclosure of interests....................................................................... 29

Subdivision B—Decisions without meetings                                                      30

47.......... Decisions without meetings.............................................................. 30

48.......... Record of decisions........................................................................... 30

Division 5—Chief Executive Officer                                                                  31

49.......... Chief Executive Officer..................................................................... 31

50.......... Functions and powers of the Chief Executive Officer....................... 31

Division 6—Staff and persons assisting the regulator                              32

51.......... Staff.................................................................................................. 32

52.......... Persons assisting the regulator.......................................................... 32

53.......... Consultants....................................................................................... 32

Part 4—Monitoring and investigation powers                                                   33

Division 1—Simplified outline                                                                                33

54.......... Simplified outline.............................................................................. 33

Division 2—Monitoring and investigation powers                                      34

55.......... Authorised officers........................................................................... 34

56.......... Monitoring powers........................................................................... 34

57.......... Investigation powers......................................................................... 36

Part 5—Miscellaneous                                                                                                       39

58.......... Simplified outline.............................................................................. 39

59.......... Reviewable decisions........................................................................ 39

60.......... Application for review by the Administrative Appeals Tribunal....... 40

61.......... Delegation......................................................................................... 40

62.......... Protection from criminal or civil actions............................................ 41

63.......... Rule‑making power........................................................................... 41

 


A Bill for an Act to establish the Regulator of Medicinal Cannabis, and for related purposes

The Parliament of Australia enacts:

Part 1Preliminary

  

1  Short title

                   This Act may be cited as the Regulator of Medicinal Cannabis Act 2014.

2  Commencement

             (1)  Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provision(s)

Commencement

Date/Details

1.  Sections 1 and 2 and anything in this Act not elsewhere covered by this table

The day this Act receives the Royal Assent.

 

2.  Sections 3 to 63

A single day to be fixed by Proclamation.

However, if the provision(s) do not commence within the period of 6 months beginning on the day this Act receives the Royal Assent, they commence on the day after the end of that period.

 

Note:          This table relates only to the provisions of this Act as originally enacted. It will not be amended to deal with any later amendments of this Act.

             (2)  Any information in column 3 of the table is not part of this Act. Information may be inserted in this column, or information in it may be edited, in any published version of this Act.

3  Objects of this Act

                   The objects of this Act are to:

                     (a)  establish a Regulator of Medicinal Cannabis to perform the functions of the agency referred to in Article 23 of the Single Convention on Narcotic Drugs, 1961, as it applies in relation to cannabis because of Article 28 of the Convention; and

                     (b)  provide for a national system, to apply in participating States and Territories, for regulating the production and use of medicinal cannabis products, and related activities such as research, in accordance with the Convention.

4  Simplified outline of this Act

This Act sets up the Regulator of Medicinal Cannabis to perform the functions of the agency referred to in Article 23 of the Single Convention on Narcotic Drugs, 1961 in relation to cannabis.

The regulator may approve medicinal cannabis products for inclusion in the register of regulated medicinal cannabis products. Products included in the register are regulated under this Act, rather than under the Therapeutic Goods Act 1989.

The regulator may make rules for licensing the production, use, experimental use and import and export of medicinal cannabis. The regulator has powers to monitor compliance with this Act and the rules, and investigate breaches.

This Act applies only in participating States and Territories. A State or Territory may enter into an arrangement with the Commonwealth to become a participating State or Territory.

5  Definitions

                   In this Act:

authorised carer has the meaning given by section 19.

authorised patient has the meaning given by section 19.

authorised patients and carers scheme means the scheme prescribed for the purposes of subsection 19(1).

cannabis has the same meaning as in the Convention, and also includes cannabis resin and cannabis plants (within the meaning of the Convention).

cannabis product means:

                     (a)  cannabis, or a product derived from cannabis, that is intended for medicinal use; or

                     (b)  a synthetic version, that is intended for medicinal use, of a product derived from cannabis.

Chair means the Chair of the regulator.

Chief Executive Officer means the Chair.

Convention means the Single Convention on Narcotic Drugs, 1961 done at New York on 30 March 1961.

Note:          The Convention could in 2014 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).

evidential material has the same meaning as in the Regulatory Powers Act.

experimental cannabis licensing scheme means the scheme prescribed for the purposes of subsection 20(1).

experimental licence means a licence issued under the experimental cannabis licensing scheme.

experimental licence holder has the meaning given by subsection 20(1).

export licence holder has the meaning given by paragraph 24(1)(b).

import and export licensing scheme means the scheme prescribed for the purposes of subsection 24(1).

import licence holder has the meaning given by paragraph 24(1)(a).

indications, in relation to cannabis products, means the specific medicinal uses of the products.

label, in relation to cannabis products, means a display of printed information:

                     (a)  on or attached to the products; or

                     (b)  on or attached to a container or primary pack in which the products are supplied; or

                     (c)  supplied with such a container or pack.

manufacture, in relation to cannabis products, means:

                     (a)  to produce the products; or

                     (b)  to engage in any part of the process of producing the products or of bringing the products to their final state, including engaging in the processing, assembling, packaging, labelling, storage, sterilising, testing or releasing for supply of the products or of any component or ingredient of the products as part of that process.

medical practitioner means a person who is registered, in a State or Territory, as a medical practitioner.

medicinal cannabis licensing scheme means the scheme prescribed for the purposes of subsection 16(1).

medicinal licence means a licence issued under the medicinal cannabis licensing scheme.

medicinal licence holder has the meaning given by subsection 16(1).

member includes the Chair.

participating State or Territory has the meaning given by section 7.

quality, in relation to cannabis products, includes the composition, strength, potency, stability, sterility and purity of the products.

register of regulated medicinal cannabis products means the register maintained under section 12.

regulated medicinal cannabis product means a cannabis product included in the register of regulated medicinal cannabis products.

regulator means the Regulator of Medicinal Cannabis established by section 28.

Regulatory Powers Act means the Regulatory Powers (Standard Provisions) Act 2014.

reviewable decision has the meaning given by section 59.

rules means the rules made under section 63.

standard means a standard determined under section 23.

6  Extension to external Territories

                   Subject to section 7, this Act extends to every external Territory.

7  Act applies only in participating States and Territories

             (1)  This Act applies only in a State or Territory that is a participating State or Territory.

             (2)  The Minister may determine, in writing, that a State or Territory is a participating State or Territory if the State or Territory has entered into an arrangement with the Commonwealth for this Act to apply in the State or Territory.

             (3)  A determination under subsection (2) is a legislative instrument, but section 42 (disallowance) of the Legislative Instruments Act 2003 does not apply to the determination.

             (4)  A Territory that is not a self‑governing Territory is taken to be a participating State or Territory.

8  Relationship with State and Territory laws

                   This Act is not intended to apply to the exclusion of a law of a State or a Territory to the extent that the law is capable of operating concurrently with this Act.

9  Act to bind Crown

                   This Act binds the Crown in right of the Commonwealth and of each of the States and Territories, but nothing in this Act renders the Crown liable to be prosecuted for an offence.

10  Arrangements with participating States and Territories

             (1)  The Minister may make arrangements with the appropriate Minister of a State, or a self‑governing Territory, that is a participating State or Territory for the carrying out by that State or Territory, on behalf of the Commonwealth, of functions under this Act.

             (2)  An arrangement under this section may provide for the payment to a participating State or Territory of amounts in respect of the performance of functions under the arrangement.

Part 2Medicinal cannabis

Division 1Simplified outline

11  Simplified outline

The regulator is responsible for maintaining a register of regulated medicinal cannabis products, which lists cannabis products approved by the regulator.

The regulator may make:

       (a)     a medicinal cannabis licensing scheme, under which licences may be given for the cultivation, production and distribution of medicinal cannabis; and

      (b)     an authorised patients and carers scheme, for authorising patients, carers and medical practitioners; and

       (c)     an experimental cannabis licensing scheme, under which licences may be given for the experimental production and use of medicinal cannabis; and

      (d)     standards for medicinal cannabis; and

       (e)     an import and export licensing scheme, under which licences may be given for the import and export of medicinal cannabis.

Division 2Regulated medicinal cannabis products

12  Register of regulated medicinal cannabis products

                   The regulator must maintain a register of regulated medicinal cannabis products in the manner prescribed by the rules.

13  Registration

             (1)  A person may apply to the regulator for a cannabis product to be included in the register of regulated medicinal cannabis products in relation to the person.

             (2)  The regulator may include a cannabis product in the register of regulated medicinal cannabis products in relation to a person if:

                     (a)  the person has made an application under subsection (1) for the cannabis product to be included in the register in relation to the person; and

                     (b)  the regulator is satisfied that the cannabis product is suitable for medicinal use; and

                     (c)  the regulator is satisfied that the cannabis product complies with any standard under this Act that applies to the product; and

                     (d)  the regulator is satisfied that including the cannabis product in the register of regulated medicinal cannabis products in relation to the person would be consistent with the Convention; and

                     (e)  the regulator is satisfied that it is appropriate in all the circumstances for the cannabis product to be regulated under this Act; and

                      (f)  any requirements prescribed by the rules are met.

             (3)  The rules may prescribe:

                     (a)  the manner in which an application under subsection (1) is to be made; and

                     (b)  matters to which the regulator may, or must, have regard in making a decision under subsection (2); and

                     (c)  procedures to be followed by the regulator in making such a decision.

14  Removal or variation of entries in the register of regulated medicinal cannabis

                   The rules may provide for an entry in the register of regulated medicinal cannabis to be removed or varied on application by the person in relation to whom the entry is registered, or on the regulator’s own initiative.

15  Cannabis products

                   For the purposes of this Act, cannabis products are to be taken to be separate and distinct from other cannabis products if they have:

                     (a)  a different formulation, composition or design specification; or

                     (b)  a different strength or size (disregarding pack size); or

                     (c)  a different dosage form or model; or

                     (d)  a different name; or

                     (e)  different indications; or

                      (f)  different directions for use; or

                     (g)  a different type of container (disregarding container size).

Division 3Medicinal cannabis licensing scheme

16  Medicinal cannabis licensing scheme

             (1)  The rules may prescribe a scheme (the medicinal cannabis licensing scheme) for the regulator to issue licences (medicinal licences) authorising persons (medicinal licence holders) to engage in one or more of the following activities:

                     (a)  producing cannabis for medicinal or experimental use;

                     (b)  transporting or storing cannabis for medicinal or experimental use;

                     (c)  manufacturing regulated medicinal cannabis products;

                     (d)  transporting or storing regulated medicinal cannabis products;

                     (e)  providing regulated medicinal cannabis products to authorised patients and authorised carers;

                      (f)  other activities incidental to the activities referred to in paragraphs (a) to (e).

Note:          The medicinal cannabis licensing scheme must be consistent with the Convention (see subsection 63(2)).

             (2)  A medicinal licence may authorise individuals to engage in activities referred to in subsection (1) on behalf of the medicinal licence holder.

             (3)  The medicinal cannabis licensing scheme must provide for a medicinal licence to be subject to such conditions as are appropriate for ensuring that:

                     (a)  all cannabis produced in accordance with the scheme is accounted for; and

                     (b)  all regulated medicinal cannabis products manufactured in accordance with the scheme are accounted for; and

                     (c)  any relevant standards are complied with; and

                     (d)  the scheme operates in accordance with the Convention.

             (4)  The Narcotic Drugs Act 1967 and the Therapeutic Goods Act 1989 do not apply in relation to an activity engaged in, or a thing dealt with, in accordance with a medicinal licence.

             (5)  Subsection (4) does not prevent the Therapeutic Goods Act 1989 applying in relation to:

                     (a)  the manufacture of therapeutic goods (within the meaning of that Act) from cannabis produced, transported or stored in accordance with a medicinal licence; or

                     (b)  therapeutic goods manufactured as referred to in paragraph (a);

if the goods are not included in the register of regulated medicinal cannabis products in relation to the manufacturer.

17  Offence of failing to comply with a condition of a medicinal licence

             (1)  A medicinal licence holder must comply with the conditions of the medicinal licence.

             (2)  A person commits an offence if:

                     (a)  the person is a medicinal licence holder; and

                     (b)  the medicinal licence is subject to a condition; and

                     (c)  the condition is not complied with.

Penalty:  300 penalty units.

18  Register of medicinal licences

             (1)  The medicinal cannabis licensing scheme must require the regulator to maintain a register of medicinal licences, in the manner specified in the scheme.

             (2)  The register must not be made available to the public.

Division 4Authorised patients and carers scheme

19  Authorised patients and carers scheme

             (1)  The rules may prescribe a scheme (the authorised patients and carers scheme) to provide for the authorisation of:

                     (a)  individuals (authorised patients) to use regulated medicinal cannabis products; and

                     (b)  individuals (authorised carers) to supply regulated medicinal cannabis products to authorised patients; and

                     (c)  authorised patients and authorised carers to do things incidental to an authorisation referred to in paragraph (a) or (b); and

                     (d)  medical practitioners, or classes of medical practitioners, to prescribe regulated medicinal cannabis products.

Note:          The authorised patients and carers scheme must be consistent with the Convention (see subsection 63(2)).

             (2)  The authorised patients and carers scheme must provide for an authorisation given under the scheme to an authorised patient or an authorised carer:

                     (a)  to be given only on request by a medical practitioner in accordance with the scheme; and

                     (b)  to be subject to such conditions as are appropriate for ensuring that the scheme operates in accordance with the Convention.

             (3)  The authorised patients and carers scheme may provide for an authorisation to be given by:

                     (a)  the regulator; or

                     (b)  an appropriate authority of a participating State or Territory.

             (4)  The Narcotic Drugs Act 1967 and the Therapeutic Goods Act 1989 do not apply in relation to an activity engaged in, or a thing dealt with, in accordance with an authorisation under the authorised patients and carers scheme.

Division 5Experimental cannabis licensing scheme

20  Experimental cannabis licensing scheme

             (1)  The rules may prescribe a scheme (the experimental cannabis licensing scheme) for the regulator to issue licences (experimental licences) authorising persons (experimental licence holders) to engage in one or more of the following activities for an experimental purpose:

                     (a)  producing cannabis;

                     (b)  manufacturing cannabis products;

                     (c)  transporting or storing cannabis or cannabis products;

                     (d)  providing or administering cannabis products;

                     (e)  performing tests on cannabis or cannabis products;

                      (f)  other activities incidental to the activities referred to in paragraphs (a) to (e).

Note:          The experimental cannabis licensing scheme must be consistent with the Convention (see subsection 63(2)).

             (2)  Without limiting subsection (1), the reference in that subsection to an experimental purpose includes the following purposes:

                     (a)  developing and testing varieties of cannabis for medicinal use;

                     (b)  improving methods of cultivating cannabis for medicinal use;

                     (c)  developing and testing cannabis products for medicinal use;

                     (d)  evaluating the efficacy or safety of cannabis products for medicinal use;

                     (e)  improving methods of using or administering cannabis products for medicinal purposes;

                      (f)  performing tests, trials and other experiments for the purposes of making or supporting an application under this Act or the Therapeutic Goods Act 1987, or considering whether to make such an application.

             (3)  An experimental licence may authorise individuals to use, possess, supply or administer cannabis products to the extent necessary for the experimental purpose.

Note:          For example, an experimental licence authorising clinical trials of a cannabis product for medicinal use may authorise test subjects to use the cannabis product and staff to possess and administer the cannabis product.

             (4)  The experimental cannabis licensing scheme must provide for an experimental licence to be subject to such conditions as are appropriate for ensuring:

                     (a)  that any cannabis produced or dealt with in accordance with the scheme is accounted for; and

                     (b)  that any cannabis products manufactured or dealt with in accordance with the scheme are accounted for; and

                     (c)  that the scheme operates in accordance with the Convention.

             (5)  The Narcotic Drugs Act 1967 and the Therapeutic Goods Act 1989 do not apply in relation to an activity engaged in, or a thing dealt with, in accordance with an experimental licence.

             (6)  Subsection (5) does not prevent the results of an experiment or trial conducted in accordance with an experimental licence being taken into account in a decision made for the purposes of the Therapeutic Goods Act 1989.

21  Offence of failing to comply with a condition of an experimental licence

                   A person commits an offence if:

                     (a)  the person is an experimental licence holder; and

                     (b)  the experimental licence is subject to a condition; and

                     (c)  the condition is not complied with.

Penalty:  300 penalty units.

22  Register of experimental licences

             (1)  The experimental cannabis licensing scheme must require the regulator to maintain a register of experimental licences, in the manner specified in the scheme.

             (2)  The register must not be made available to the public.

Division 6Medicinal cannabis standards

23  Determination of standards

             (1)  The rules may provide for the regulator to determine, by legislative instrument, standards for:

                     (a)  cannabis or cannabis products; or

                     (b)  an activity that may be carried out under a medicinal licence or an experimental licence.

             (2)  Without limiting subsection (1), a standard may:

                     (a)  be specified by reference to:

                              (i)  the quality of a cannabis product; or

                             (ii)  the quantity of a cannabis product when contained in specified containers; or

                            (iii)  the characteristics of a variety of cannabis for cultivation; or

                            (iv)  a monograph in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia‑National Formulary; or

                             (v)  a monograph in another publication approved by the regulator for the purposes of this subsection; or

                            (vi)  such a monograph as modified in a manner specified in the standard; or

                           (vii)  a standard published by Standards Australia; or

                          (viii)  such other matters as the regulator thinks fit; or

                     (b)  require that a matter relating to the standard be determined in accordance with a particular test; or

                     (c)  require that cannabis, cannabis products or a class of cannabis or cannabis products identified in the standard be labelled or packaged in a manner, or kept in containers that comply with requirements, specified in the standard.

             (3)  Without limiting paragraph (2)(c), a standard may require that there be set out, in a manner specified in the standard, on:

                     (a)  cannabis, cannabis products or a class of cannabis or cannabis products identified in the standard; or

                     (b)  a container or package containing cannabis, cannabis products or a class of cannabis or cannabis products identified in the standard; or

                     (c)  a label of cannabis, cannabis products or a class of cannabis or cannabis products identified in the standard;

such particulars as are required by the standard.

Division 7Import and export licensing scheme

24  Import and export licensing scheme

             (1)  The rules may prescribe a scheme (the import and export licensing scheme) for the regulator to:

                     (a)  issue licences (import licences) authorising persons (import licence holders) to import cannabis or cannabis products into Australia for medicinal or experimental purposes in accordance with this Act; and

                     (b)  issue licences (export licences) authorising persons (export licence holders) to export cannabis or cannabis products from Australia for medicinal or experimental purposes.

Note:          The import and export licensing scheme must be consistent with the Convention (see subsection 63(2)).

             (2)  An import licence or an export licence may authorise individuals to engage in activities referred to in subsection (1) on behalf of the holder of the licence.

             (3)  The import and export licensing scheme must provide for an import licence or an export licence to be subject to such conditions as are appropriate for ensuring:

                     (a)  that any cannabis or cannabis products imported or exported in accordance with the scheme are accounted for; and

                     (b)  that the scheme operates in accordance with the Convention.

             (4)  The Narcotic Drugs Act 1967 and the Therapeutic Goods Act 1989 do not apply in relation to an activity engaged in, or a thing dealt with, in accordance with an import licence or an export licence.

25  Offence of failing to comply with a condition of an import licence or an export licence

                   A person commits an offence if:

                     (a)  the person holds an import licence or an export licence; and

                     (b)  the licence is subject to a condition; and

                     (c)  the condition is not complied with.

Penalty:  300 penalty units.

26  Register of import licences and export licences

                   The import and export licensing scheme must require the regulator to:

                     (a)  maintain a register of import licences and export licences, in the manner specified in the scheme; and

                     (b)  make the register available to the public.

Part 3Regulator of Medicinal Cannabis

Division 1Simplified outline

27  Simplified outline

The regulator is established under the Public Governance, Performance and Accountability Act 2013.

The regulator has functions relating to medicinal cannabis, which it must perform in a manner consistent with the Convention.

Division 2Establishment, functions and powers of the regulator

28  Establishment

             (1)  The Regulator of Medicinal Cannabis (the regulator) is established by this section.

             (2)  For the purposes of the finance law (within the meaning of the Public Governance, Performance and Accountability Act 2013):

                     (a)  the regulator is a listed entity; and

                     (b)  the members are the accountable authority of the regulator; and

                     (c)  the following persons are officials of the regulator:

                              (i)  the members;

                             (ii)  the Chief Executive Officer;

                            (iii)  the staff of the regulator; and

                     (d)  the purposes of the regulator include the functions of the regulator referred to in section 30.

29  Constitution

                   The regulator consists of:

                     (a)  a Chair; and

                     (b)  5 other members.

Note:          The regulator does not have a legal identity separate from the Commonwealth.

30  Functions and powers

             (1)  The regulator has the following functions:

                     (a)  the functions of the agency referred to in Article 23 of the Convention, as it applies in relation to cannabis because of Article 28 of the Convention;

                     (b)  to enter into contracts with medicinal licence holders, experimental licence holders, import licence holders and export licence holders;

                     (c)  to supply cannabis within Australia for the purposes of manufacturing regulated medicinal cannabis products;

                     (d)  to supply regulated medicinal cannabis products within Australia for medicinal purposes;

                     (e)  to supply cannabis and cannabis products within Australia for experimental purposes;

                      (f)  to investigate whether this Act or the rules have been or are being complied with;

                     (g)  to advise and make recommendations to the Minister on matters relating to medicinal or experimental cannabis and cannabis products, if requested by the Minister or on its own initiative;

                     (h)  to collect, analyse, interpret and disseminate information and statistics relating to medicinal or experimental cannabis and cannabis products;

                      (i)  to educate and inform patients, carers, health workers and the community about the medicinal use of regulated medicinal cannabis products;

                      (j)  to provide training to health workers in relation to the medicinal use of regulated medicinal cannabis products;

                     (k)  to cooperate with its counterparts in other countries;

                      (l)  to cooperate with law enforcement agencies in Australia and in other countries;

                    (m)  such other functions as are conferred on the regulator by or under this Act or any other Commonwealth law.

             (2)  The regulator may perform its functions within or outside Australia.

             (3)  The regulator has the power to do all things that are necessary or convenient to be done for or in connection with the performance of its functions.

             (4)  The regulator must perform its functions and exercise its powers in a manner consistent with the Convention.

             (5)  The Narcotic Drugs Act 1967 and the Therapeutic Goods Act 1989 do not apply in relation to the performance of the regulator’s functions or the exercise of its powers.

31  Independence of the regulator

                   Subject to section 32, the regulator is not subject to direction from anyone in relation to the performance of its functions or the exercise of its powers.

32  Minister may give directions to the regulator

             (1)  The Minister may, by legislative instrument, give a direction to the regulator if the Minister considers that the direction is necessary to ensure that Australia complies with its obligations under the Convention.

Note:          Section 42 (disallowance) and Part 6 (sunsetting) of the Legislative Instruments Act 2003 do not apply to the direction (see sections 44 and 54 of that Act).

             (2)  The regulator must comply with a direction given under subsection (1).

33  The regulator has privileges and immunities of the Crown

                   The regulator has the privileges and immunities of the Crown in right of the Commonwealth.

Division 3Appointment of members

34  Appointment

             (1)  The Chair is to be appointed by the Minister, by written instrument, on a full‑time basis.

             (2)  The members other than the Chair are to be appointed by the Minister, by written instrument, on a part‑time basis.

             (3)  The Minister is to appoint a person as a member only if the Minister is satisfied that the person is qualified for appointment because of his or her knowledge of, or experience in, one or more of the following fields:

                     (a)  medicine;

                     (b)  pharmacology;

                     (c)  palliative care;

                     (d)  botany;

                     (e)  horticulture;

                      (f)  law;

                     (g)  law enforcement;

                     (h)  advocacy for patients and other users of medical services.

             (4)  In making appointments under this section, the Minister must ensure that:

                     (a)  at least one member is a medical practitioner; and

                     (b)  at least one member is a member of the Australian Federal Police; and

                     (c)  at least one member represents the interests of patients and other users of medical services.

35  Term of appointment

                   A member holds office for the period specified in the instrument of appointment. The period must not exceed 5 years.

Note:          For reappointment, see section 33AA of the Acts Interpretation Act 1901.

36  Remuneration and allowances

             (1)  A member is to be paid the remuneration that is determined by the Remuneration Tribunal. If no determination of that remuneration by the Tribunal is in operation, the member is to be paid the remuneration that is determined, in writing, by the Minister.

             (2)  A member is to be paid the allowances that are determined, in writing, by the Minister.

             (3)  This section has effect subject to the Remuneration Tribunal Act 1973.

37  Leave of absence

             (1)  The Chair has the recreation leave entitlements that are determined by the Remuneration Tribunal.

             (2)  The Minister may grant the Chair leave of absence, other than recreation leave, on the terms and conditions as to remuneration or otherwise that the Minister determines.

             (3)  The Chair may grant leave of absence to a member other than the Chair on the terms and conditions that the Chair determines.

38  Outside employment

             (1)  The Chair must not engage in paid employment outside the duties of his or her office without the Minister’s approval.

             (2)  A member other than the Chair must not engage in any paid employment that, in the Minister’s opinion, conflicts or may conflict with the proper performance of his or her duties.

39  Disclosure of interests to the Minister

             (1)  A member must give written notice to the Minister of all interests, pecuniary or otherwise, that the member has or acquires that conflict or could conflict with the proper performance of the member’s functions.

             (2)  The notice must be given to the Minister as soon as practicable after the member becomes aware of the potential for conflict of interest.

40  Other terms and conditions

                   A member holds office on the terms and conditions (if any) in relation to matters not covered by this Act that are determined, in writing, by the Minister.

41  Resignation

             (1)  A member may resign his or her appointment by giving the Minister a written resignation.

             (2)  The resignation takes effect on the day it is received by the Minister or, if a later day is specified in the resignation, on that later day.

Note:          If the Chair resigns, he or she also resigns his or her position as the Chief Executive Officer. This does not prevent a person who is both the Chair and Chief Executive Officer from being reappointed only as a member.

42  Termination of appointment

                   The Minister may terminate the appointment of a member:

                     (a)  for misbehaviour; or

                     (b)  if the member is unable to perform the duties of his or her office because of physical or mental incapacity; or

                     (c)  if the member:

                              (i)  becomes bankrupt; or

                             (ii)  applies to take the benefit of any law for the relief of bankrupt or insolvent debtors; or

                            (iii)  compounds with his or her creditors; or

                            (iv)  makes an assignment of his or her remuneration for the benefit of his or her creditors; or

                     (d)  if the member is absent, except on leave of absence, for 14 consecutive days or for 28 days in any 12 months; or

                     (e)  if the member engages in paid employment contrary to section 38; or

                      (f)  if the member fails, without reasonable excuse, to comply with section 39 or 46.

43  Acting appointments

Acting Chair

             (1)  The Minister may, by written instrument, appoint a member to act as the Chair:

                     (a)  during a vacancy in the office of the Chair (whether or not an appointment has previously been made to the office); or

                     (b)  during any period, or during all periods, when the Chair:

                              (i)  is absent from duty or from Australia; or

                             (ii)  is, for any reason, unable to perform the duties of the office.

Acting member

             (2)  The Minister may, by written instrument, appoint a person to act as a member (other than the Chair):

                     (a)  during a vacancy in the office of the member (whether or not an appointment has previously been made to the office); or

                     (b)  during any period, or during all periods, when the member:

                              (i)  is absent from duty or from Australia; or

                             (ii)  is, for any reason, unable to perform the duties of the office.

Requirements before appointing a person to act

             (3)  A person may only be appointed to act as the Chair, or as a member, if the Minister is satisfied that the person has appropriate qualifications, knowledge or experience.

Note:          For rules that apply to acting appointments, see sections 33AB and 33A of the Acts Interpretation Act 1901.

Division 4Procedures of the regulator

Subdivision AMeetings

44  Times and places of meetings

             (1)  The Chair must ensure that such meetings are held as are necessary for the efficient performance of the regulator’s functions.

             (2)  Meetings are to be held at such times and places as the Chair decides.

             (3)  The Chair must convene a meeting if requested, in writing, by at least 2 of the other members.

45  Conduct of meetings

Presiding at meetings

             (1)  The Chair presides at all meetings at which he or she is present.

             (2)  If the Chair is not present at a meeting, a member:

                     (a)  nominated by the Chair; and

                     (b)  present at the meeting;

must preside.

Quorum

             (3)  At a meeting of the regulator, a quorum is constituted by 4 members.

Rules of procedure

             (4)  The regulator may, subject to this Division, regulate proceedings at its meetings as it considers appropriate.

Note:          Section 33B of the Acts Interpretation Act 1901 provides for participation in meetings by telephone etc.

Voting

             (5)  The person presiding at a meeting of the regulator has a deliberative vote but, if the votes are equal, does not have a casting vote.

Minutes

             (6)  The regulator must ensure that minutes of its meetings are kept.

46  Disclosure of interests

             (1)  If a member has an interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting, the member must disclose the nature of that interest to the other members.

             (2)  The disclosure must be made as soon as possible after the relevant facts have come to the member’s knowledge.

             (3)  The disclosure must be recorded in the minutes of the meeting.

             (4)  Unless the regulator otherwise determines, the member:

                     (a)  must not be present during the regulator’s deliberation on the matter; and

                     (b)  must not take part in the regulator’s decision on the matter.

             (5)  For the purposes of the regulator making a determination under subsection (4), the member:

                     (a)  must not be present during any of the regulator’s deliberations for the purpose of making the determination; and

                     (b)  must not take part in making the determination.

             (6)  A determination under subsection (4) must be recorded in the minutes of the meeting.

Subdivision BDecisions without meetings

47  Decisions without meetings

             (1)  A decision is taken to have been made at a meeting of the regulator if:

                     (a)  without meeting, a majority of members indicate agreement with the proposed decision in accordance with the method determined by the regulator under subsection (2); and

                     (b)  all members were informed of the proposed decision, or reasonable efforts were made to inform all members of the proposed decision.

             (2)  Subsection (1) applies if the regulator:

                     (a)  has determined that it applies; and

                     (b)  has determined the method by which members are to indicate agreement with proposed decisions.

48  Record of decisions

                   The regulator must keep a record of decisions made in accordance with section 47.

Division 5Chief Executive Officer

49  Chief Executive Officer

             (1)  There is to be a Chief Executive Officer of the regulator.

             (2)  The Chair is the Chief Executive Officer.

50  Functions and powers of the Chief Executive Officer

             (1)  The Chief Executive Officer is responsible for the management and administration of the regulator.

             (2)  All acts and things done in the name of, or on behalf of, the regulator by the Chief Executive Officer are taken to have been done by the regulator.

Division 6Staff and persons assisting the regulator

51  Staff

             (1)  The staff of the regulator are to be persons engaged under the Public Service Act 1999.

             (2)  For the purposes of the Public Service Act 1999:

                     (a)  the Chief Executive Officer and the staff of the regulator together constitute a Statutory Agency; and

                     (b)  the Chief Executive Officer is the Head of that Statutory Agency.

52  Persons assisting the regulator

                   The regulator may be assisted:

                     (a)  by employees of Agencies (within the meaning of the Public Service Act 1999); or

                     (b)  by officers or employees of a participating State or Territory; or

                     (c)  by officers or employees of authorities of the Commonwealth or a participating State or Territory;

whose services are made available to the regulator in connection with the performance of the regulator’s functions.

53  Consultants

             (1)  The regulator may, on behalf of the Commonwealth, engage persons having suitable qualifications and experience as consultants to the regulator.

             (2)  The consultants are to be engaged on the terms and conditions that the regulator determines in writing.

Part 4Monitoring and investigation powers

Division 1Simplified outline

54  Simplified outline

The regulator may authorise members, members of staff and officers and employees of participating States and Territories who are assisting the regulator to exercise monitoring and investigation powers under the Regulatory Powers Act.

Division 2Monitoring and investigation powers

55  Authorised officers

                   The regulator may, in writing, authorise any of the following people for the purposes of subsection 56(4) or (5) or 57(3) or (4):

                     (a)  a member;

                     (b)  a member of the staff of the regulator;

                     (c)  with the agreement of a participating State or Territory—an officer or employee of the State or Territory, or of an authority of the State or Territory, who is assisting the regulator in accordance with section 52.

56  Monitoring powers

Provisions subject to monitoring

             (1)  The following provisions (the monitoring powers provisions) are subject to monitoring under Part 2 of the Regulatory Powers Act:

                     (a)  Part 2 (other than Division 4) of this Act;

                     (b)  rules made for the purposes of Part 2 (other than Division 4) of this Act.

Note:          Part 2 of the Regulatory Powers Act creates a framework for monitoring whether these provisions have been complied with. It includes powers of entry, search and inspection (see section 20 of that Act).

Information subject to monitoring

             (2)  Information given in compliance or purported compliance with a monitoring powers provision is subject to monitoring under Part 2 of the Regulatory Powers Act.

Note:          Part 2 of the Regulatory Powers Act creates a framework for monitoring whether the information is correct. It includes powers of entry, search and inspection (see section 20 of that Act).

Related provisions

             (3)  For the purposes of Part 2 of the Regulatory Powers Act, a provision for an offence against the Crimes Act 1914 or the Criminal Code that relates to a monitoring powers provision is related to the monitoring powers provision and the information mentioned in subsection (2).

Authorised applicant

             (4)  For the purposes of Part 2 of the Regulatory Powers Act, a person authorised under section 55 of this Act for the purposes of this subsection is an authorised applicant in relation to:

                     (a)  the monitoring powers provisions; and

                     (b)  the information mentioned in subsection (2).

Authorised person

             (5)  For the purposes of Part 2 of the Regulatory Powers Act, a person authorised under section 55 of this Act for the purposes of this subsection is an authorised person in relation to:

                     (a)  the monitoring powers provisions; and

                     (b)  the information mentioned in subsection (2).

Issuing officer

             (6)  For the purposes of Part 2 of the Regulatory Powers Act, a magistrate, or a Judge of the Federal Circuit Court, is an issuing officer in relation to:

                     (a)  the monitoring powers provisions; and

                     (b)  the information mentioned in subsection (2).

Relevant chief executive

             (7)  For the purposes of Part 2 of the Regulatory Powers Act, the Chief Executive Officer is the relevant chief executive in relation to:

                     (a)  the monitoring powers provisions; and

                     (b)  the information mentioned in subsection (2).

Relevant court

             (8)  For the purposes of Part 2 of the Regulatory Powers Act, each of the following courts is a relevant court in relation to the listed provisions and the information mentioned in subsection (2):

                     (a)  the Federal Court of Australia;

                     (b)  the Federal Circuit Court of Australia;

                     (c)  the Supreme Court of a State or Territory.

Person assisting

             (9)  For the purposes of Part 2 of the Regulatory Powers Act, a person authorised under section 55 of this Act for the purposes of subsection (4) or (5) of this section may be assisted by a member (or members) of the staff of the regulator in exercising powers or performing functions in relation to:

                     (a)  the monitoring powers provisions; or

                     (b)  the information mentioned in subsection (2).

57  Investigation powers

Offences that are subject to investigation

             (1)  The following are subject to investigation under Part 3 of the Regulatory Powers Act:

                     (a)  an offence against this Act;

                     (b)  an offence against the Crimes Act 1914 or the Criminal Code that relates to this Act.

Note:          Part 3 of the Regulatory Powers Act creates a framework for investigating whether offences that are subject to investigation have been committed. It includes powers of entry, search, inspection and seizure (see section 50 of that Act).

Related provisions

             (2)  For the purposes of Part 3 of the Regulatory Powers Act, each of the following is related to evidential material that relates to an offence mentioned in subsection (1):

                     (a)  a provision for an offence against this Act;

                     (b)  a provision for an offence against the Crimes Act 1914 or the Criminal Code that relates to this Act.

Authorised applicant

             (3)  For the purposes of Part 3 of the Regulatory Powers Act, a person authorised under section 55 of this Act for the purposes of this subsection is an authorised applicant in relation to evidential material that relates to an offence mentioned in subsection (1).

Authorised person

             (4)  For the purposes of Part 3 of the Regulatory Powers Act, a person authorised under section 55 of this Act for the purposes of this subsection is an authorised person in relation to evidential material that relates to an offence mentioned in subsection (1).

Issuing officer

             (5)  For the purposes of Part 3 of the Regulatory Powers Act, a magistrate, or a Judge of the Federal Circuit Court, is an issuing officer in relation to evidential material that relates to an offence mentioned in subsection (1).

Relevant chief executive

             (6)  For the purposes of Part 3 of the Regulatory Powers Act, the Chief Executive Officer is the relevant chief executive in relation to evidential material that relates to an offence mentioned in subsection (1).

Relevant court

             (7)  For the purposes of Part 3 of the Regulatory Powers Act, each of the following courts is a relevant court in relation to evidential material that relates to an offence mentioned in subsection (1):

                     (a)  the Federal Court;

                     (b)  the Federal Circuit Court;

                     (c)  the Supreme Court of a State or Territory.

Person assisting

             (8)  For the purposes of Part 3 of the Regulatory Powers Act, a person authorised under section 55 of this Act for the purposes of subsection (3) or (4) of this section may be assisted by a member (or members) of the staff of the regulator in exercising powers or performing functions in relation to evidential material that relates to an offence mentioned in subsection (1).

Use of force in executing a warrant

             (9)  In executing an investigation warrant:

                     (a)  an authorised person may use such force against things as is necessary and reasonable in the circumstances; and

                     (b)  a person assisting the authorised person may use such force against things as is necessary and reasonable in the circumstances.

Part 5Miscellaneous

  

58  Simplified outline

This Part deals with miscellaneous matters, such as delegations, rules and review of decisions.

59  Reviewable decisions

             (1)  For the purposes of this Act, each of the following decisions made under this Act is a reviewable decision:

                     (a)  a decision not to include a cannabis product in the register of regulated medicinal cannabis products in relation to a person;

                     (b)  a decision to remove or vary, or not to remove or vary, an entry in the register of regulated medicinal cannabis products;

                     (c)  a decision not to issue a medicinal licence;

                     (d)  a decision to revoke or vary a medicinal licence, or to impose a condition on a medicinal licence;

                     (e)  a decision not to give an authorisation under the authorised patients and carers scheme;

                      (f)  a decision to revoke or vary an authorisation under the authorised patients and carers scheme, or to impose a condition on such an authorisation;

                     (g)  a decision not to issue an experimental licence;

                     (h)  a decision to revoke or vary an experimental licence, or to impose a condition on an experimental licence;

                      (i)  a decision not to issue an import licence or an export licence;

                      (j)  a decision to revoke or vary an import licence or an export licence, or to impose a condition on an import licence or an export licence.

             (2)  The rules may provide that a decision made under the rules is a reviewable decision for the purposes of this Act.

60  Application for review by the Administrative Appeals Tribunal

                   An application may be made to the Administrative Appeals Tribunal for review of a reviewable decision.

61  Delegation

             (1)  The regulator may, by writing, delegate any or all of the regulator’s functions and powers to:

                     (a)  a member; or

                     (b)  an SES employee, or acting SES employee, who is a member of the staff of the regulator; or

                     (c)  with the agreement of a participating State or Territory—an officer or employee of the State or Territory, or of an authority of the State or Territory, who:

                              (i)  is assisting the regulator in accordance with section 52; and

                             (ii)  holds, or acts in, an office or position at a level equivalent to that of an SES employee.

             (2)  Subsection (1) does not apply to the power to make rules under section 63 or to the power to make any of the following decisions:

                     (a)  a decision to include a cannabis product in the register of regulated medicinal cannabis products in relation to a person;

                     (b)  a decision to remove or vary an entry in the register of regulated medicinal cannabis products;

                     (c)  a decision to issue or vary a medicinal licence, or to impose a condition on a medicinal licence;

                     (d)  a decision to issue or vary an experimental licence, or to impose a condition on an experimental licence;

                     (e)  a decision to issue or vary an import licence or an export licence, or to impose a condition on an import licence or an export licence.

             (3)  In performing functions or exercising powers under a delegation, the delegate must comply with any written directions of the regulator.

62  Protection from criminal or civil actions

             (1)  No action, suit or proceeding (whether criminal or civil) lies against a protected person in relation to anything done, or omitted to be done, in good faith by the person:

                     (a)  in accordance, or purportedly in accordance, with this Act; or

                     (b)  in the performance, or purported performance, of the regulator’s functions; or

                     (c)  in the exercise, or purported exercise, of the regulator’s powers.

Note:          This section extends to, for example, a thing done in good faith in accordance with a delegation under section 61.

             (2)  The protected persons are as follows:

                     (a)  the Minister;

                     (b)  a member;

                     (c)  a member of the staff of the regulator;

                     (d)  a Commonwealth authority;

                     (e)  a person who holds any office or appointment under a law of the Commonwealth or of a State or Territory;

                      (f)  a person assisting the regulator in accordance with section 52.

63  Rule‑making power

             (1)  The regulator may, by legislative instrument, make rules prescribing matters:

                     (a)  required or permitted by this Act to be prescribed by the rules; or

                     (b)  necessary or convenient to be prescribed for carrying out or giving effect to this Act.

             (2)  The rules must be consistent with the Convention.

Fees

             (3)  The rules may prescribe fees that the regulator may charge for things done in the performance of its functions.

             (4)  The rules may prescribe the way in which a fee is to be worked out.

             (5)  Fees prescribed by the rules must not be such as to amount to taxation.