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This is a Bill, not an Act. For current law, see the Acts databases.
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
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
i
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
ii
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
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
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
iii
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
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
1
A Bill for an Act to establish the Regulator of
1
Medicinal Cannabis, and for related purposes
2
The Parliament of Australia enacts:
3
Part 1--Preliminary
4
5
1 Short title
6
This Act may be cited as the Regulator of Medicinal Cannabis Act
7
2014.
8
Part 1 Preliminary
Section 2
2
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
2 Commencement
1
(1) Each provision of this Act specified in column 1 of the table
2
commences, or is taken to have commenced, in accordance with
3
column 2 of the table. Any other statement in column 2 has effect
4
according to its terms.
5
6
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
7
enacted. It will not be amended to deal with any later amendments of
8
this Act.
9
(2) Any information in column 3 of the table is not part of this Act.
10
Information may be inserted in this column, or information in it
11
may be edited, in any published version of this Act.
12
3 Objects of this Act
13
The objects of this Act are to:
14
(a) establish a Regulator of Medicinal Cannabis to perform the
15
functions of the agency referred to in Article 23 of the Single
16
Convention on Narcotic Drugs, 1961, as it applies in relation
17
to cannabis because of Article 28 of the Convention; and
18
(b) provide for a national system, to apply in participating States
19
and Territories, for regulating the production and use of
20
Preliminary Part 1
Section 4
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
3
medicinal cannabis products, and related activities such as
1
research, in accordance with the Convention.
2
4 Simplified outline of this Act
3
This Act sets up the Regulator of Medicinal Cannabis to perform
4
the functions of the agency referred to in Article 23 of the Single
5
Convention on Narcotic Drugs, 1961 in relation to cannabis.
6
The regulator may approve medicinal cannabis products for
7
inclusion in the register of regulated medicinal cannabis products.
8
Products included in the register are regulated under this Act,
9
rather than under the Therapeutic Goods Act 1989.
10
The regulator may make rules for licensing the production, use,
11
experimental use and import and export of medicinal cannabis. The
12
regulator has powers to monitor compliance with this Act and the
13
rules, and investigate breaches.
14
This Act applies only in participating States and Territories. A
15
State or Territory may enter into an arrangement with the
16
Commonwealth to become a participating State or Territory.
17
5 Definitions
18
In this Act:
19
authorised carer has the meaning given by section 19.
20
authorised patient has the meaning given by section 19.
21
authorised patients and carers scheme means the scheme
22
prescribed for the purposes of subsection 19(1).
23
cannabis has the same meaning as in the Convention, and also
24
includes cannabis resin and cannabis plants (within the meaning of
25
the Convention).
26
cannabis product means:
27
Part 1 Preliminary
Section 5
4
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
(a) cannabis, or a product derived from cannabis, that is intended
1
for medicinal use; or
2
(b) a synthetic version, that is intended for medicinal use, of a
3
product derived from cannabis.
4
Chair means the Chair of the regulator.
5
Chief Executive Officer means the Chair.
6
Convention means the Single Convention on Narcotic Drugs, 1961
7
done at New York on 30 March 1961.
8
Note:
The Convention could in 2014 be viewed in the Australian Treaties
9
Library on the AustLII website (http://www.austlii.edu.au).
10
evidential material has the same meaning as in the Regulatory
11
Powers Act.
12
experimental cannabis licensing scheme means the scheme
13
prescribed for the purposes of subsection 20(1).
14
experimental licence means a licence issued under the
15
experimental cannabis licensing scheme.
16
experimental licence holder has the meaning given by
17
subsection 20(1).
18
export licence holder has the meaning given by
19
paragraph 24(1)(b).
20
import and export licensing scheme means the scheme prescribed
21
for the purposes of subsection 24(1).
22
import licence holder has the meaning given by
23
paragraph 24(1)(a).
24
indications, in relation to cannabis products, means the specific
25
medicinal uses of the products.
26
label, in relation to cannabis products, means a display of printed
27
information:
28
(a) on or attached to the products; or
29
Preliminary Part 1
Section 5
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
5
(b) on or attached to a container or primary pack in which the
1
products are supplied; or
2
(c) supplied with such a container or pack.
3
manufacture, in relation to cannabis products, means:
4
(a) to produce the products; or
5
(b) to engage in any part of the process of producing the products
6
or of bringing the products to their final state, including
7
engaging in the processing, assembling, packaging, labelling,
8
storage, sterilising, testing or releasing for supply of the
9
products or of any component or ingredient of the products as
10
part of that process.
11
medical practitioner means a person who is registered, in a State
12
or Territory, as a medical practitioner.
13
medicinal cannabis licensing scheme means the scheme
14
prescribed for the purposes of subsection 16(1).
15
medicinal licence means a licence issued under the medicinal
16
cannabis licensing scheme.
17
medicinal licence holder has the meaning given by
18
subsection 16(1).
19
member includes the Chair.
20
participating State or Territory has the meaning given by
21
section 7.
22
quality, in relation to cannabis products, includes the composition,
23
strength, potency, stability, sterility and purity of the products.
24
register of regulated medicinal cannabis products means the
25
register maintained under section 12.
26
regulated medicinal cannabis product means a cannabis product
27
included in the register of regulated medicinal cannabis products.
28
regulator means the Regulator of Medicinal Cannabis established
29
by section 28.
30
Part 1 Preliminary
Section 6
6
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
Regulatory Powers Act means the Regulatory Powers (Standard
1
Provisions) Act 2014.
2
reviewable decision has the meaning given by section 59.
3
rules means the rules made under section 63.
4
standard means a standard determined under section 23.
5
6 Extension to external Territories
6
Subject to section 7, this Act extends to every external Territory.
7
7 Act applies only in participating States and Territories
8
(1) This Act applies only in a State or Territory that is a participating
9
State or Territory.
10
(2) The Minister may determine, in writing, that a State or Territory is
11
a participating State or Territory if the State or Territory has
12
entered into an arrangement with the Commonwealth for this Act
13
to apply in the State or Territory.
14
(3) A determination under subsection (2) is a legislative instrument,
15
but section 42 (disallowance) of the Legislative Instruments Act
16
2003 does not apply to the determination.
17
(4) A Territory that is not a self-governing Territory is taken to be a
18
participating State or Territory.
19
8 Relationship with State and Territory laws
20
This Act is not intended to apply to the exclusion of a law of a
21
State or a Territory to the extent that the law is capable of
22
operating concurrently with this Act.
23
9 Act to bind Crown
24
This Act binds the Crown in right of the Commonwealth and of
25
each of the States and Territories, but nothing in this Act renders
26
the Crown liable to be prosecuted for an offence.
27
Preliminary Part 1
Section 10
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
7
10 Arrangements with participating States and Territories
1
(1) The Minister may make arrangements with the appropriate
2
Minister of a State, or a self-governing Territory, that is a
3
participating State or Territory for the carrying out by that State or
4
Territory, on behalf of the Commonwealth, of functions under this
5
Act.
6
(2) An arrangement under this section may provide for the payment to
7
a participating State or Territory of amounts in respect of the
8
performance of functions under the arrangement.
9
Part 2 Medicinal cannabis
Division 1 Simplified outline
Section 11
8
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
Part 2--Medicinal cannabis
1
Division 1--Simplified outline
2
11 Simplified outline
3
The regulator is responsible for maintaining a register of regulated
4
medicinal cannabis products, which lists cannabis products
5
approved by the regulator.
6
The regulator may make:
7
(a)
a medicinal cannabis licensing scheme, under which
8
licences may be given for the cultivation, production and
9
distribution of medicinal cannabis; and
10
(b)
an authorised patients and carers scheme, for authorising
11
patients, carers and medical practitioners; and
12
(c)
an experimental cannabis licensing scheme, under which
13
licences may be given for the experimental production
14
and use of medicinal cannabis; and
15
(d)
standards for medicinal cannabis; and
16
(e)
an import and export licensing scheme, under which
17
licences may be given for the import and export of
18
medicinal cannabis.
19
Medicinal cannabis Part 2
Regulated medicinal cannabis products Division 2
Section 12
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
9
Division 2--Regulated medicinal cannabis products
1
12 Register of regulated medicinal cannabis products
2
The regulator must maintain a register of regulated medicinal
3
cannabis products in the manner prescribed by the rules.
4
13 Registration
5
(1) A person may apply to the regulator for a cannabis product to be
6
included in the register of regulated medicinal cannabis products in
7
relation to the person.
8
(2) The regulator may include a cannabis product in the register of
9
regulated medicinal cannabis products in relation to a person if:
10
(a) the person has made an application under subsection (1) for
11
the cannabis product to be included in the register in relation
12
to the person; and
13
(b) the regulator is satisfied that the cannabis product is suitable
14
for medicinal use; and
15
(c) the regulator is satisfied that the cannabis product complies
16
with any standard under this Act that applies to the product;
17
and
18
(d) the regulator is satisfied that including the cannabis product
19
in the register of regulated medicinal cannabis products in
20
relation to the person would be consistent with the
21
Convention; and
22
(e) the regulator is satisfied that it is appropriate in all the
23
circumstances for the cannabis product to be regulated under
24
this Act; and
25
(f) any requirements prescribed by the rules are met.
26
(3) The rules may prescribe:
27
(a) the manner in which an application under subsection (1) is to
28
be made; and
29
(b) matters to which the regulator may, or must, have regard in
30
making a decision under subsection (2); and
31
Part 2 Medicinal cannabis
Division 2 Regulated medicinal cannabis products
Section 14
10
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
(c) procedures to be followed by the regulator in making such a
1
decision.
2
14 Removal or variation of entries in the register of regulated
3
medicinal cannabis
4
The rules may provide for an entry in the register of regulated
5
medicinal cannabis to be removed or varied on application by the
6
person in relation to whom the entry is registered, or on the
7
regulator's own initiative.
8
15 Cannabis products
9
For the purposes of this Act, cannabis products are to be taken to
10
be separate and distinct from other cannabis products if they have:
11
(a) a different formulation, composition or design specification;
12
or
13
(b) a different strength or size (disregarding pack size); or
14
(c) a different dosage form or model; or
15
(d) a different name; or
16
(e) different indications; or
17
(f) different directions for use; or
18
(g) a different type of container (disregarding container size).
19
Medicinal cannabis Part 2
Medicinal cannabis licensing scheme Division 3
Section 16
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
11
Division 3--Medicinal cannabis licensing scheme
1
16 Medicinal cannabis licensing scheme
2
(1) The rules may prescribe a scheme (the medicinal cannabis
3
licensing scheme) for the regulator to issue licences (medicinal
4
licences) authorising persons (medicinal licence holders) to
5
engage in one or more of the following activities:
6
(a) producing cannabis for medicinal or experimental use;
7
(b) transporting or storing cannabis for medicinal or
8
experimental use;
9
(c) manufacturing regulated medicinal cannabis products;
10
(d) transporting or storing regulated medicinal cannabis
11
products;
12
(e) providing regulated medicinal cannabis products to
13
authorised patients and authorised carers;
14
(f) other activities incidental to the activities referred to in
15
paragraphs (a) to (e).
16
Note:
The medicinal cannabis licensing scheme must be consistent with the
17
Convention (see subsection 63(2)).
18
(2) A medicinal licence may authorise individuals to engage in
19
activities referred to in subsection (1) on behalf of the medicinal
20
licence holder.
21
(3) The medicinal cannabis licensing scheme must provide for a
22
medicinal licence to be subject to such conditions as are
23
appropriate for ensuring that:
24
(a) all cannabis produced in accordance with the scheme is
25
accounted for; and
26
(b) all regulated medicinal cannabis products manufactured in
27
accordance with the scheme are accounted for; and
28
(c) any relevant standards are complied with; and
29
(d) the scheme operates in accordance with the Convention.
30
(4) The Narcotic Drugs Act 1967 and the Therapeutic Goods Act 1989
31
do not apply in relation to an activity engaged in, or a thing dealt
32
with, in accordance with a medicinal licence.
33
Part 2 Medicinal cannabis
Division 3 Medicinal cannabis licensing scheme
Section 17
12
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
(5) Subsection (4) does not prevent the Therapeutic Goods Act 1989
1
applying in relation to:
2
(a) the manufacture of therapeutic goods (within the meaning of
3
that Act) from cannabis produced, transported or stored in
4
accordance with a medicinal licence; or
5
(b) therapeutic goods manufactured as referred to in
6
paragraph (a);
7
if the goods are not included in the register of regulated medicinal
8
cannabis products in relation to the manufacturer.
9
17 Offence of failing to comply with a condition of a medicinal
10
licence
11
(1) A medicinal licence holder must comply with the conditions of the
12
medicinal licence.
13
(2) A person commits an offence if:
14
(a) the person is a medicinal licence holder; and
15
(b) the medicinal licence is subject to a condition; and
16
(c) the condition is not complied with.
17
Penalty: 300 penalty units.
18
18 Register of medicinal licences
19
(1) The medicinal cannabis licensing scheme must require the
20
regulator to maintain a register of medicinal licences, in the
21
manner specified in the scheme.
22
(2) The register must not be made available to the public.
23
Medicinal cannabis Part 2
Authorised patients and carers scheme Division 4
Section 19
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
13
Division 4--Authorised patients and carers scheme
1
19 Authorised patients and carers scheme
2
(1) The rules may prescribe a scheme (the authorised patients and
3
carers scheme) to provide for the authorisation of:
4
(a) individuals (authorised patients) to use regulated medicinal
5
cannabis products; and
6
(b) individuals (authorised carers) to supply regulated medicinal
7
cannabis products to authorised patients; and
8
(c) authorised patients and authorised carers to do things
9
incidental to an authorisation referred to in paragraph (a) or
10
(b); and
11
(d) medical practitioners, or classes of medical practitioners, to
12
prescribe regulated medicinal cannabis products.
13
Note:
The authorised patients and carers scheme must be consistent with the
14
Convention (see subsection 63(2)).
15
(2) The authorised patients and carers scheme must provide for an
16
authorisation given under the scheme to an authorised patient or an
17
authorised carer:
18
(a) to be given only on request by a medical practitioner in
19
accordance with the scheme; and
20
(b) to be subject to such conditions as are appropriate for
21
ensuring that the scheme operates in accordance with the
22
Convention.
23
(3) The authorised patients and carers scheme may provide for an
24
authorisation to be given by:
25
(a) the regulator; or
26
(b) an appropriate authority of a participating State or Territory.
27
(4) The Narcotic Drugs Act 1967 and the Therapeutic Goods Act 1989
28
do not apply in relation to an activity engaged in, or a thing dealt
29
with, in accordance with an authorisation under the authorised
30
patients and carers scheme.
31
Part 2 Medicinal cannabis
Division 5 Experimental cannabis licensing scheme
Section 20
14
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
Division 5--Experimental cannabis licensing scheme
1
20 Experimental cannabis licensing scheme
2
(1) The rules may prescribe a scheme (the experimental cannabis
3
licensing scheme) for the regulator to issue licences (experimental
4
licences) authorising persons (experimental licence holders) to
5
engage in one or more of the following activities for an
6
experimental purpose:
7
(a) producing cannabis;
8
(b) manufacturing cannabis products;
9
(c) transporting or storing cannabis or cannabis products;
10
(d) providing or administering cannabis products;
11
(e) performing tests on cannabis or cannabis products;
12
(f) other activities incidental to the activities referred to in
13
paragraphs (a) to (e).
14
Note:
The experimental cannabis licensing scheme must be consistent with
15
the Convention (see subsection 63(2)).
16
(2) Without limiting subsection (1), the reference in that subsection to
17
an experimental purpose includes the following purposes:
18
(a) developing and testing varieties of cannabis for medicinal
19
use;
20
(b) improving methods of cultivating cannabis for medicinal use;
21
(c) developing and testing cannabis products for medicinal use;
22
(d) evaluating the efficacy or safety of cannabis products for
23
medicinal use;
24
(e) improving methods of using or administering cannabis
25
products for medicinal purposes;
26
(f) performing tests, trials and other experiments for the
27
purposes of making or supporting an application under this
28
Act or the Therapeutic Goods Act 1987, or considering
29
whether to make such an application.
30
(3) An experimental licence may authorise individuals to use, possess,
31
supply or administer cannabis products to the extent necessary for
32
the experimental purpose.
33
Medicinal cannabis Part 2
Experimental cannabis licensing scheme Division 5
Section 21
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
15
Note:
For example, an experimental licence authorising clinical trials of a
1
cannabis product for medicinal use may authorise test subjects to use
2
the cannabis product and staff to possess and administer the cannabis
3
product.
4
(4) The experimental cannabis licensing scheme must provide for an
5
experimental licence to be subject to such conditions as are
6
appropriate for ensuring:
7
(a) that any cannabis produced or dealt with in accordance with
8
the scheme is accounted for; and
9
(b) that any cannabis products manufactured or dealt with in
10
accordance with the scheme are accounted for; and
11
(c) that the scheme operates in accordance with the Convention.
12
(5) The Narcotic Drugs Act 1967 and the Therapeutic Goods Act 1989
13
do not apply in relation to an activity engaged in, or a thing dealt
14
with, in accordance with an experimental licence.
15
(6) Subsection (5) does not prevent the results of an experiment or trial
16
conducted in accordance with an experimental licence being taken
17
into account in a decision made for the purposes of the Therapeutic
18
Goods Act 1989.
19
21 Offence of failing to comply with a condition of an experimental
20
licence
21
A person commits an offence if:
22
(a) the person is an experimental licence holder; and
23
(b) the experimental licence is subject to a condition; and
24
(c) the condition is not complied with.
25
Penalty: 300 penalty units.
26
22 Register of experimental licences
27
(1) The experimental cannabis licensing scheme must require the
28
regulator to maintain a register of experimental licences, in the
29
manner specified in the scheme.
30
(2) The register must not be made available to the public.
31
Part 2 Medicinal cannabis
Division 6 Medicinal cannabis standards
Section 23
16
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
Division 6--Medicinal cannabis standards
1
23 Determination of standards
2
(1) The rules may provide for the regulator to determine, by legislative
3
instrument, standards for:
4
(a) cannabis or cannabis products; or
5
(b) an activity that may be carried out under a medicinal licence
6
or an experimental licence.
7
(2) Without limiting subsection (1), a standard may:
8
(a) be specified by reference to:
9
(i) the quality of a cannabis product; or
10
(ii) the quantity of a cannabis product when contained in
11
specified containers; or
12
(iii) the characteristics of a variety of cannabis for
13
cultivation; or
14
(iv) a monograph in the British Pharmacopoeia, the
15
European Pharmacopoeia or the United States
16
Pharmacopeia-National Formulary; or
17
(v) a monograph in another publication approved by the
18
regulator for the purposes of this subsection; or
19
(vi) such a monograph as modified in a manner specified in
20
the standard; or
21
(vii) a standard published by Standards Australia; or
22
(viii) such other matters as the regulator thinks fit; or
23
(b) require that a matter relating to the standard be determined in
24
accordance with a particular test; or
25
(c) require that cannabis, cannabis products or a class of
26
cannabis or cannabis products identified in the standard be
27
labelled or packaged in a manner, or kept in containers that
28
comply with requirements, specified in the standard.
29
(3) Without limiting paragraph (2)(c), a standard may require that
30
there be set out, in a manner specified in the standard, on:
31
(a) cannabis, cannabis products or a class of cannabis or
32
cannabis products identified in the standard; or
33
Medicinal cannabis Part 2
Medicinal cannabis standards Division 6
Section 23
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
17
(b) a container or package containing cannabis, cannabis
1
products or a class of cannabis or cannabis products
2
identified in the standard; or
3
(c) a label of cannabis, cannabis products or a class of cannabis
4
or cannabis products identified in the standard;
5
such particulars as are required by the standard.
6
Part 2 Medicinal cannabis
Division 7 Import and export licensing scheme
Section 24
18
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
Division 7--Import and export licensing scheme
1
24 Import and export licensing scheme
2
(1) The rules may prescribe a scheme (the import and export licensing
3
scheme) for the regulator to:
4
(a) issue licences (import licences) authorising persons (import
5
licence holders) to import cannabis or cannabis products into
6
Australia for medicinal or experimental purposes in
7
accordance with this Act; and
8
(b) issue licences (export licences) authorising persons (export
9
licence holders) to export cannabis or cannabis products
10
from Australia for medicinal or experimental purposes.
11
Note:
The import and export licensing scheme must be consistent with the
12
Convention (see subsection 63(2)).
13
(2) An import licence or an export licence may authorise individuals to
14
engage in activities referred to in subsection (1) on behalf of the
15
holder of the licence.
16
(3) The import and export licensing scheme must provide for an
17
import licence or an export licence to be subject to such conditions
18
as are appropriate for ensuring:
19
(a) that any cannabis or cannabis products imported or exported
20
in accordance with the scheme are accounted for; and
21
(b) that the scheme operates in accordance with the Convention.
22
(4) The Narcotic Drugs Act 1967 and the Therapeutic Goods Act 1989
23
do not apply in relation to an activity engaged in, or a thing dealt
24
with, in accordance with an import licence or an export licence.
25
25 Offence of failing to comply with a condition of an import licence
26
or an export licence
27
A person commits an offence if:
28
(a) the person holds an import licence or an export licence; and
29
(b) the licence is subject to a condition; and
30
(c) the condition is not complied with.
31
Medicinal cannabis Part 2
Import and export licensing scheme Division 7
Section 26
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
19
Penalty: 300 penalty units.
1
26 Register of import licences and export licences
2
The import and export licensing scheme must require the regulator
3
to:
4
(a) maintain a register of import licences and export licences, in
5
the manner specified in the scheme; and
6
(b) make the register available to the public.
7
Part 3 Regulator of Medicinal Cannabis
Division 1 Simplified outline
Section 27
20
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
Part 3--Regulator of Medicinal Cannabis
1
Division 1--Simplified outline
2
27 Simplified outline
3
The regulator is established under the Public Governance,
4
Performance and Accountability Act 2013.
5
The regulator has functions relating to medicinal cannabis, which it
6
must perform in a manner consistent with the Convention.
7
Regulator of Medicinal Cannabis Part 3
Establishment, functions and powers of the regulator Division 2
Section 28
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
21
Division 2--Establishment, functions and powers of the
1
regulator
2
28 Establishment
3
(1) The Regulator of Medicinal Cannabis (the regulator) is established
4
by this section.
5
(2) For the purposes of the finance law (within the meaning of the
6
Public Governance, Performance and Accountability Act 2013):
7
(a) the regulator is a listed entity; and
8
(b) the members are the accountable authority of the regulator;
9
and
10
(c) the following persons are officials of the regulator:
11
(i) the members;
12
(ii) the Chief Executive Officer;
13
(iii) the staff of the regulator; and
14
(d) the purposes of the regulator include the functions of the
15
regulator referred to in section 30.
16
29 Constitution
17
The regulator consists of:
18
(a) a Chair; and
19
(b) 5 other members.
20
Note:
The regulator does not have a legal identity separate from the
21
Commonwealth.
22
30 Functions and powers
23
(1) The regulator has the following functions:
24
(a) the functions of the agency referred to in Article 23 of the
25
Convention, as it applies in relation to cannabis because of
26
Article 28 of the Convention;
27
(b) to enter into contracts with medicinal licence holders,
28
experimental licence holders, import licence holders and
29
export licence holders;
30
Part 3 Regulator of Medicinal Cannabis
Division 2 Establishment, functions and powers of the regulator
Section 30
22
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
(c) to supply cannabis within Australia for the purposes of
1
manufacturing regulated medicinal cannabis products;
2
(d) to supply regulated medicinal cannabis products within
3
Australia for medicinal purposes;
4
(e) to supply cannabis and cannabis products within Australia for
5
experimental purposes;
6
(f) to investigate whether this Act or the rules have been or are
7
being complied with;
8
(g) to advise and make recommendations to the Minister on
9
matters relating to medicinal or experimental cannabis and
10
cannabis products, if requested by the Minister or on its own
11
initiative;
12
(h) to collect, analyse, interpret and disseminate information and
13
statistics relating to medicinal or experimental cannabis and
14
cannabis products;
15
(i) to educate and inform patients, carers, health workers and the
16
community about the medicinal use of regulated medicinal
17
cannabis products;
18
(j) to provide training to health workers in relation to the
19
medicinal use of regulated medicinal cannabis products;
20
(k) to cooperate with its counterparts in other countries;
21
(l) to cooperate with law enforcement agencies in Australia and
22
in other countries;
23
(m) such other functions as are conferred on the regulator by or
24
under this Act or any other Commonwealth law.
25
(2) The regulator may perform its functions within or outside
26
Australia.
27
(3) The regulator has the power to do all things that are necessary or
28
convenient to be done for or in connection with the performance of
29
its functions.
30
(4) The regulator must perform its functions and exercise its powers in
31
a manner consistent with the Convention.
32
(5) The Narcotic Drugs Act 1967 and the Therapeutic Goods Act 1989
33
do not apply in relation to the performance of the regulator's
34
functions or the exercise of its powers.
35
Regulator of Medicinal Cannabis Part 3
Establishment, functions and powers of the regulator Division 2
Section 31
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
23
31 Independence of the regulator
1
Subject to section 32, the regulator is not subject to direction from
2
anyone in relation to the performance of its functions or the
3
exercise of its powers.
4
32 Minister may give directions to the regulator
5
(1) The Minister may, by legislative instrument, give a direction to the
6
regulator if the Minister considers that the direction is necessary to
7
ensure that Australia complies with its obligations under the
8
Convention.
9
Note:
Section 42 (disallowance) and Part 6 (sunsetting) of the Legislative
10
Instruments Act 2003 do not apply to the direction (see sections 44
11
and 54 of that Act).
12
(2) The regulator must comply with a direction given under
13
subsection (1).
14
33 The regulator has privileges and immunities of the Crown
15
The regulator has the privileges and immunities of the Crown in
16
right of the Commonwealth.
17
Part 3 Regulator of Medicinal Cannabis
Division 3 Appointment of members
Section 34
24
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
Division 3--Appointment of members
1
34 Appointment
2
(1) The Chair is to be appointed by the Minister, by written
3
instrument, on a full-time basis.
4
(2) The members other than the Chair are to be appointed by the
5
Minister, by written instrument, on a part-time basis.
6
(3) The Minister is to appoint a person as a member only if the
7
Minister is satisfied that the person is qualified for appointment
8
because of his or her knowledge of, or experience in, one or more
9
of the following fields:
10
(a) medicine;
11
(b) pharmacology;
12
(c) palliative care;
13
(d) botany;
14
(e) horticulture;
15
(f) law;
16
(g) law enforcement;
17
(h) advocacy for patients and other users of medical services.
18
(4) In making appointments under this section, the Minister must
19
ensure that:
20
(a) at least one member is a medical practitioner; and
21
(b) at least one member is a member of the Australian Federal
22
Police; and
23
(c) at least one member represents the interests of patients and
24
other users of medical services.
25
35 Term of appointment
26
A member holds office for the period specified in the instrument of
27
appointment. The period must not exceed 5 years.
28
Note:
For reappointment, see section 33AA of the Acts Interpretation Act
29
1901.
30
Regulator of Medicinal Cannabis Part 3
Appointment of members Division 3
Section 36
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
25
36 Remuneration and allowances
1
(1) A member is to be paid the remuneration that is determined by the
2
Remuneration Tribunal. If no determination of that remuneration
3
by the Tribunal is in operation, the member is to be paid the
4
remuneration that is determined, in writing, by the Minister.
5
(2) A member is to be paid the allowances that are determined, in
6
writing, by the Minister.
7
(3) This section has effect subject to the Remuneration Tribunal Act
8
1973.
9
37 Leave of absence
10
(1) The Chair has the recreation leave entitlements that are determined
11
by the Remuneration Tribunal.
12
(2) The Minister may grant the Chair leave of absence, other than
13
recreation leave, on the terms and conditions as to remuneration or
14
otherwise that the Minister determines.
15
(3) The Chair may grant leave of absence to a member other than the
16
Chair on the terms and conditions that the Chair determines.
17
38 Outside employment
18
(1) The Chair must not engage in paid employment outside the duties
19
of his or her office without the Minister's approval.
20
(2) A member other than the Chair must not engage in any paid
21
employment that, in the Minister's opinion, conflicts or may
22
conflict with the proper performance of his or her duties.
23
39 Disclosure of interests to the Minister
24
(1) A member must give written notice to the Minister of all interests,
25
pecuniary or otherwise, that the member has or acquires that
26
conflict or could conflict with the proper performance of the
27
member's functions.
28
Part 3 Regulator of Medicinal Cannabis
Division 3 Appointment of members
Section 40
26
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
(2) The notice must be given to the Minister as soon as practicable
1
after the member becomes aware of the potential for conflict of
2
interest.
3
40 Other terms and conditions
4
A member holds office on the terms and conditions (if any) in
5
relation to matters not covered by this Act that are determined, in
6
writing, by the Minister.
7
41 Resignation
8
(1) A member may resign his or her appointment by giving the
9
Minister a written resignation.
10
(2) The resignation takes effect on the day it is received by the
11
Minister or, if a later day is specified in the resignation, on that
12
later day.
13
Note:
If the Chair resigns, he or she also resigns his or her position as the
14
Chief Executive Officer. This does not prevent a person who is both
15
the Chair and Chief Executive Officer from being reappointed only as
16
a member.
17
42 Termination of appointment
18
The Minister may terminate the appointment of a member:
19
(a) for misbehaviour; or
20
(b) if the member is unable to perform the duties of his or her
21
office because of physical or mental incapacity; or
22
(c) if the member:
23
(i) becomes bankrupt; or
24
(ii) applies to take the benefit of any law for the relief of
25
bankrupt or insolvent debtors; or
26
(iii) compounds with his or her creditors; or
27
(iv) makes an assignment of his or her remuneration for the
28
benefit of his or her creditors; or
29
(d) if the member is absent, except on leave of absence, for 14
30
consecutive days or for 28 days in any 12 months; or
31
Regulator of Medicinal Cannabis Part 3
Appointment of members Division 3
Section 43
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
27
(e) if the member engages in paid employment contrary to
1
section 38; or
2
(f) if the member fails, without reasonable excuse, to comply
3
with section 39 or 46.
4
43 Acting appointments
5
Acting Chair
6
(1) The Minister may, by written instrument, appoint a member to act
7
as the Chair:
8
(a) during a vacancy in the office of the Chair (whether or not an
9
appointment has previously been made to the office); or
10
(b) during any period, or during all periods, when the Chair:
11
(i) is absent from duty or from Australia; or
12
(ii) is, for any reason, unable to perform the duties of the
13
office.
14
Acting member
15
(2) The Minister may, by written instrument, appoint a person to act as
16
a member (other than the Chair):
17
(a) during a vacancy in the office of the member (whether or not
18
an appointment has previously been made to the office); or
19
(b) during any period, or during all periods, when the member:
20
(i) is absent from duty or from Australia; or
21
(ii) is, for any reason, unable to perform the duties of the
22
office.
23
Requirements before appointing a person to act
24
(3) A person may only be appointed to act as the Chair, or as a
25
member, if the Minister is satisfied that the person has appropriate
26
qualifications, knowledge or experience.
27
Note:
For rules that apply to acting appointments, see sections 33AB and
28
33A of the Acts Interpretation Act 1901.
29
Part 3 Regulator of Medicinal Cannabis
Division 4 Procedures of the regulator
Section 44
28
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
Division 4--Procedures of the regulator
1
Subdivision A--Meetings
2
44 Times and places of meetings
3
(1) The Chair must ensure that such meetings are held as are necessary
4
for the efficient performance of the regulator's functions.
5
(2) Meetings are to be held at such times and places as the Chair
6
decides.
7
(3) The Chair must convene a meeting if requested, in writing, by at
8
least 2 of the other members.
9
45 Conduct of meetings
10
Presiding at meetings
11
(1) The Chair presides at all meetings at which he or she is present.
12
(2) If the Chair is not present at a meeting, a member:
13
(a) nominated by the Chair; and
14
(b) present at the meeting;
15
must preside.
16
Quorum
17
(3) At a meeting of the regulator, a quorum is constituted by 4
18
members.
19
Rules of procedure
20
(4) The regulator may, subject to this Division, regulate proceedings at
21
its meetings as it considers appropriate.
22
Note:
Section 33B of the Acts Interpretation Act 1901 provides for
23
participation in meetings by telephone etc.
24
Regulator of Medicinal Cannabis Part 3
Procedures of the regulator Division 4
Section 46
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
29
Voting
1
(5) The person presiding at a meeting of the regulator has a
2
deliberative vote but, if the votes are equal, does not have a casting
3
vote.
4
Minutes
5
(6) The regulator must ensure that minutes of its meetings are kept.
6
46 Disclosure of interests
7
(1) If a member has an interest, pecuniary or otherwise, in a matter
8
being considered, or about to be considered, at a meeting, the
9
member must disclose the nature of that interest to the other
10
members.
11
(2) The disclosure must be made as soon as possible after the relevant
12
facts have come to the member's knowledge.
13
(3) The disclosure must be recorded in the minutes of the meeting.
14
(4) Unless the regulator otherwise determines, the member:
15
(a) must not be present during the regulator's deliberation on the
16
matter; and
17
(b) must not take part in the regulator's decision on the matter.
18
(5) For the purposes of the regulator making a determination under
19
subsection (4), the member:
20
(a) must not be present during any of the regulator's
21
deliberations for the purpose of making the determination;
22
and
23
(b) must not take part in making the determination.
24
(6) A determination under subsection (4) must be recorded in the
25
minutes of the meeting.
26
Part 3 Regulator of Medicinal Cannabis
Division 4 Procedures of the regulator
Section 47
30
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
Subdivision B--Decisions without meetings
1
47 Decisions without meetings
2
(1) A decision is taken to have been made at a meeting of the regulator
3
if:
4
(a) without meeting, a majority of members indicate agreement
5
with the proposed decision in accordance with the method
6
determined by the regulator under subsection (2); and
7
(b) all members were informed of the proposed decision, or
8
reasonable efforts were made to inform all members of the
9
proposed decision.
10
(2) Subsection (1) applies if the regulator:
11
(a) has determined that it applies; and
12
(b) has determined the method by which members are to indicate
13
agreement with proposed decisions.
14
48 Record of decisions
15
The regulator must keep a record of decisions made in accordance
16
with section 47.
17
Regulator of Medicinal Cannabis Part 3
Chief Executive Officer Division 5
Section 49
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
31
Division 5--Chief Executive Officer
1
49 Chief Executive Officer
2
(1) There is to be a Chief Executive Officer of the regulator.
3
(2) The Chair is the Chief Executive Officer.
4
50 Functions and powers of the Chief Executive Officer
5
(1) The Chief Executive Officer is responsible for the management
6
and administration of the regulator.
7
(2) All acts and things done in the name of, or on behalf of, the
8
regulator by the Chief Executive Officer are taken to have been
9
done by the regulator.
10
Part 3 Regulator of Medicinal Cannabis
Division 6 Staff and persons assisting the regulator
Section 51
32
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
Division 6--Staff and persons assisting the regulator
1
51 Staff
2
(1) The staff of the regulator are to be persons engaged under the
3
Public Service Act 1999.
4
(2) For the purposes of the Public Service Act 1999:
5
(a) the Chief Executive Officer and the staff of the regulator
6
together constitute a Statutory Agency; and
7
(b) the Chief Executive Officer is the Head of that Statutory
8
Agency.
9
52 Persons assisting the regulator
10
The regulator may be assisted:
11
(a) by employees of Agencies (within the meaning of the Public
12
Service Act 1999); or
13
(b) by officers or employees of a participating State or Territory;
14
or
15
(c) by officers or employees of authorities of the Commonwealth
16
or a participating State or Territory;
17
whose services are made available to the regulator in connection
18
with the performance of the regulator's functions.
19
53 Consultants
20
(1) The regulator may, on behalf of the Commonwealth, engage
21
persons having suitable qualifications and experience as
22
consultants to the regulator.
23
(2) The consultants are to be engaged on the terms and conditions that
24
the regulator determines in writing.
25
Monitoring and investigation powers Part 4
Simplified outline Division 1
Section 54
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
33
Part 4--Monitoring and investigation powers
1
Division 1--Simplified outline
2
54 Simplified outline
3
The regulator may authorise members, members of staff and
4
officers and employees of participating States and Territories who
5
are assisting the regulator to exercise monitoring and investigation
6
powers under the Regulatory Powers Act.
7
Part 4 Monitoring and investigation powers
Division 2 Monitoring and investigation powers
Section 55
34
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
Division 2--Monitoring and investigation powers
1
55 Authorised officers
2
The regulator may, in writing, authorise any of the following
3
people for the purposes of subsection 56(4) or (5) or 57(3) or (4):
4
(a) a member;
5
(b) a member of the staff of the regulator;
6
(c) with the agreement of a participating State or Territory--an
7
officer or employee of the State or Territory, or of an
8
authority of the State or Territory, who is assisting the
9
regulator in accordance with section 52.
10
56 Monitoring powers
11
Provisions subject to monitoring
12
(1) The following provisions (the monitoring powers provisions) are
13
subject to monitoring under Part 2 of the Regulatory Powers Act:
14
(a) Part 2 (other than Division 4) of this Act;
15
(b) rules made for the purposes of Part 2 (other than Division 4)
16
of this Act.
17
Note:
Part 2 of the Regulatory Powers Act creates a framework for
18
monitoring whether these provisions have been complied with. It
19
includes powers of entry, search and inspection (see section 20 of that
20
Act).
21
Information subject to monitoring
22
(2) Information given in compliance or purported compliance with a
23
monitoring powers provision is subject to monitoring under Part 2
24
of the Regulatory Powers Act.
25
Note:
Part 2 of the Regulatory Powers Act creates a framework for
26
monitoring whether the information is correct. It includes powers of
27
entry, search and inspection (see section 20 of that Act).
28
Monitoring and investigation powers Part 4
Monitoring and investigation powers Division 2
Section 56
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
35
Related provisions
1
(3) For the purposes of Part 2 of the Regulatory Powers Act, a
2
provision for an offence against the Crimes Act 1914 or the
3
Criminal Code that relates to a monitoring powers provision is
4
related to the monitoring powers provision and the information
5
mentioned in subsection (2).
6
Authorised applicant
7
(4) For the purposes of Part 2 of the Regulatory Powers Act, a person
8
authorised under section 55 of this Act for the purposes of this
9
subsection is an authorised applicant in relation to:
10
(a) the monitoring powers provisions; and
11
(b) the information mentioned in subsection (2).
12
Authorised person
13
(5) For the purposes of Part 2 of the Regulatory Powers Act, a person
14
authorised under section 55 of this Act for the purposes of this
15
subsection is an authorised person in relation to:
16
(a) the monitoring powers provisions; and
17
(b) the information mentioned in subsection (2).
18
Issuing officer
19
(6) For the purposes of Part 2 of the Regulatory Powers Act, a
20
magistrate, or a Judge of the Federal Circuit Court, is an issuing
21
officer in relation to:
22
(a) the monitoring powers provisions; and
23
(b) the information mentioned in subsection (2).
24
Relevant chief executive
25
(7) For the purposes of Part 2 of the Regulatory Powers Act, the Chief
26
Executive Officer is the relevant chief executive in relation to:
27
(a) the monitoring powers provisions; and
28
(b) the information mentioned in subsection (2).
29
Part 4 Monitoring and investigation powers
Division 2 Monitoring and investigation powers
Section 57
36
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
Relevant court
1
(8) For the purposes of Part 2 of the Regulatory Powers Act, each of
2
the following courts is a relevant court in relation to the listed
3
provisions and the information mentioned in subsection (2):
4
(a) the Federal Court of Australia;
5
(b) the Federal Circuit Court of Australia;
6
(c) the Supreme Court of a State or Territory.
7
Person assisting
8
(9) For the purposes of Part 2 of the Regulatory Powers Act, a person
9
authorised under section 55 of this Act for the purposes of
10
subsection (4) or (5) of this section may be assisted by a member
11
(or members) of the staff of the regulator in exercising powers or
12
performing functions in relation to:
13
(a) the monitoring powers provisions; or
14
(b) the information mentioned in subsection (2).
15
57 Investigation powers
16
Offences that are subject to investigation
17
(1) The following are subject to investigation under Part 3 of the
18
Regulatory Powers Act:
19
(a) an offence against this Act;
20
(b) an offence against the Crimes Act 1914 or the Criminal Code
21
that relates to this Act.
22
Note:
Part 3 of the Regulatory Powers Act creates a framework for
23
investigating whether offences that are subject to investigation have
24
been committed. It includes powers of entry, search, inspection and
25
seizure (see section 50 of that Act).
26
Related provisions
27
(2) For the purposes of Part 3 of the Regulatory Powers Act, each of
28
the following is related to evidential material that relates to an
29
offence mentioned in subsection (1):
30
(a) a provision for an offence against this Act;
31
Monitoring and investigation powers Part 4
Monitoring and investigation powers Division 2
Section 57
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
37
(b) a provision for an offence against the Crimes Act 1914 or the
1
Criminal Code that relates to this Act.
2
Authorised applicant
3
(3) For the purposes of Part 3 of the Regulatory Powers Act, a person
4
authorised under section 55 of this Act for the purposes of this
5
subsection is an authorised applicant in relation to evidential
6
material that relates to an offence mentioned in subsection (1).
7
Authorised person
8
(4) For the purposes of Part 3 of the Regulatory Powers Act, a person
9
authorised under section 55 of this Act for the purposes of this
10
subsection is an authorised person in relation to evidential
11
material that relates to an offence mentioned in subsection (1).
12
Issuing officer
13
(5) For the purposes of Part 3 of the Regulatory Powers Act, a
14
magistrate, or a Judge of the Federal Circuit Court, is an issuing
15
officer in relation to evidential material that relates to an offence
16
mentioned in subsection (1).
17
Relevant chief executive
18
(6) For the purposes of Part 3 of the Regulatory Powers Act, the Chief
19
Executive Officer is the relevant chief executive in relation to
20
evidential material that relates to an offence mentioned in
21
subsection (1).
22
Relevant court
23
(7) For the purposes of Part 3 of the Regulatory Powers Act, each of
24
the following courts is a relevant court in relation to evidential
25
material that relates to an offence mentioned in subsection (1):
26
(a) the Federal Court;
27
(b) the Federal Circuit Court;
28
(c) the Supreme Court of a State or Territory.
29
Part 4 Monitoring and investigation powers
Division 2 Monitoring and investigation powers
Section 57
38
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
Person assisting
1
(8) For the purposes of Part 3 of the Regulatory Powers Act, a person
2
authorised under section 55 of this Act for the purposes of
3
subsection (3) or (4) of this section may be assisted by a member
4
(or members) of the staff of the regulator in exercising powers or
5
performing functions in relation to evidential material that relates
6
to an offence mentioned in subsection (1).
7
Use of force in executing a warrant
8
(9) In executing an investigation warrant:
9
(a) an authorised person may use such force against things as is
10
necessary and reasonable in the circumstances; and
11
(b) a person assisting the authorised person may use such force
12
against things as is necessary and reasonable in the
13
circumstances.
14
Miscellaneous Part 5
Section 58
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
39
Part 5--Miscellaneous
1
2
58 Simplified outline
3
This Part deals with miscellaneous matters, such as delegations,
4
rules and review of decisions.
5
59 Reviewable decisions
6
(1) For the purposes of this Act, each of the following decisions made
7
under this Act is a reviewable decision:
8
(a) a decision not to include a cannabis product in the register of
9
regulated medicinal cannabis products in relation to a person;
10
(b) a decision to remove or vary, or not to remove or vary, an
11
entry in the register of regulated medicinal cannabis
12
products;
13
(c) a decision not to issue a medicinal licence;
14
(d) a decision to revoke or vary a medicinal licence, or to impose
15
a condition on a medicinal licence;
16
(e) a decision not to give an authorisation under the authorised
17
patients and carers scheme;
18
(f) a decision to revoke or vary an authorisation under the
19
authorised patients and carers scheme, or to impose a
20
condition on such an authorisation;
21
(g) a decision not to issue an experimental licence;
22
(h) a decision to revoke or vary an experimental licence, or to
23
impose a condition on an experimental licence;
24
(i) a decision not to issue an import licence or an export licence;
25
(j) a decision to revoke or vary an import licence or an export
26
licence, or to impose a condition on an import licence or an
27
export licence.
28
(2) The rules may provide that a decision made under the rules is a
29
reviewable decision for the purposes of this Act.
30
Part 5 Miscellaneous
Section 60
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Regulator of Medicinal Cannabis Bill 2014
No. , 2014
60 Application for review by the Administrative Appeals Tribunal
1
An application may be made to the Administrative Appeals
2
Tribunal for review of a reviewable decision.
3
61 Delegation
4
(1) The regulator may, by writing, delegate any or all of the regulator's
5
functions and powers to:
6
(a) a member; or
7
(b) an SES employee, or acting SES employee, who is a member
8
of the staff of the regulator; or
9
(c) with the agreement of a participating State or Territory--an
10
officer or employee of the State or Territory, or of an
11
authority of the State or Territory, who:
12
(i) is assisting the regulator in accordance with section 52;
13
and
14
(ii) holds, or acts in, an office or position at a level
15
equivalent to that of an SES employee.
16
(2) Subsection (1) does not apply to the power to make rules under
17
section 63 or to the power to make any of the following decisions:
18
(a) a decision to include a cannabis product in the register of
19
regulated medicinal cannabis products in relation to a person;
20
(b) a decision to remove or vary an entry in the register of
21
regulated medicinal cannabis products;
22
(c) a decision to issue or vary a medicinal licence, or to impose a
23
condition on a medicinal licence;
24
(d) a decision to issue or vary an experimental licence, or to
25
impose a condition on an experimental licence;
26
(e) a decision to issue or vary an import licence or an export
27
licence, or to impose a condition on an import licence or an
28
export licence.
29
(3) In performing functions or exercising powers under a delegation,
30
the delegate must comply with any written directions of the
31
regulator.
32
Miscellaneous Part 5
Section 62
No. , 2014
Regulator of Medicinal Cannabis Bill 2014
41
62 Protection from criminal or civil actions
1
(1) No action, suit or proceeding (whether criminal or civil) lies
2
against a protected person in relation to anything done, or omitted
3
to be done, in good faith by the person:
4
(a) in accordance, or purportedly in accordance, with this Act; or
5
(b) in the performance, or purported performance, of the
6
regulator's functions; or
7
(c) in the exercise, or purported exercise, of the regulator's
8
powers.
9
Note:
This section extends to, for example, a thing done in good faith in
10
accordance with a delegation under section 61.
11
(2) The protected persons are as follows:
12
(a) the Minister;
13
(b) a member;
14
(c) a member of the staff of the regulator;
15
(d) a Commonwealth authority;
16
(e) a person who holds any office or appointment under a law of
17
the Commonwealth or of a State or Territory;
18
(f) a person assisting the regulator in accordance with
19
section 52.
20
63 Rule-making power
21
(1) The regulator may, by legislative instrument, make rules
22
prescribing matters:
23
(a) required or permitted by this Act to be prescribed by the
24
rules; or
25
(b) necessary or convenient to be prescribed for carrying out or
26
giving effect to this Act.
27
(2) The rules must be consistent with the Convention.
28
Fees
29
(3) The rules may prescribe fees that the regulator may charge for
30
things done in the performance of its functions.
31
Part 5 Miscellaneous
Section 63
42
Regulator of Medicinal Cannabis Bill 2014
No. , 2014
(4) The rules may prescribe the way in which a fee is to be worked
1
out.
2
(5) Fees prescribed by the rules must not be such as to amount to
3
taxation.
4