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2016
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
NARCOTIC DRUGS LEGISLATION AMENDMENT BILL 2016
EXPLANATORY MEMORANDUM
(Circulated by authority of the Minister for Health and Aged Care/Minister for Sport,
the Hon Sussan Ley MP)
NARCOTIC DRUGS LEGISLATION AMENDMENT BILL 2016
OUTLINE
The Narcotic Drugs Legislation Amendment Bill 2016 (the Bill) makes amendments
to the Narcotic Drugs Act 1967 and also makes a small number of related
amendments to the Therapeutic Goods Act 1989 in relation to medicinal cannabis.
The amendments relate, in particular, to the protection of sensitive law enforcement
information that may be disclosed by law enforcement agencies to the Secretary of the
Department of Health (the Secretary) for the purposes of regulatory action relating to
medicinal cannabis licences, cannabis research licences and manufacture licences.
The regulatory scheme for the licensing of the cultivation of cannabis plants and
production of cannabis and cannabis resins was established by the amendments made
earlier this year to the Narcotic Drugs Act 1967 by the Narcotic Drugs Amendment
Act 2016.
The Narcotic Drugs Amendment Act 2016 (which commences by Proclamation, or on
30 October 2016) amends the Narcotic Drugs Act 1967 to set out a legislative
framework enabling the cultivation of cannabis plants and the production of cannabis
and cannabis resins in Australia for the purpose of providing Australian patients with
access to medicinal cannabis for therapeutic purposes. Those amendments are also
designed to ensure that when cultivation and production of cannabis and cannabis
resins and manufacture of cannabis products for medicinal purposes begin, Australia
will remain compliant with its international treaty obligations in the United Nations
Single Convention on Narcotic Drugs, 1961 (the Single Convention).
The Narcotic Drugs Amendment Act 2016 establishes a licensing scheme for the
cultivation of cannabis for medicinal and related scientific purposes. Two of the key
features of this scheme are:
two cannabis licences, one that authorises the cultivation of cannabis for
manufacture into medicinal cannabis products; the second that authorises
cultivation of cannabis plants for research into medicinal purposes. Such
research could include, for example, research into growing conditions, yields
and other matters related to ensuring a safe, predictable raw material
a 'fit and proper person' test to be applied to applicants for these licences and to
relevant business associates of applicants, in order to ensure that criminal
elements, including organised crime, do not infiltrate the licence scheme and
use it as cover for illegal activities. This test involves consideration of a range
of matters including criminal history, connections and associates, financial
status, business history and capacity to comply with licensing requirements.
The fit and proper person test applies in a number of ways under the amendments to
the Narcotic Drugs Act 1967 made by the Narcotic Drugs Amendment Act 2016.
In particular, the Secretary must refuse to grant a licence if not satisfied on reasonable
grounds that an applicant and each of the applicant's relevant business associates in
relation to the application is not a fit and proper person to hold the licence or to
associate with a licence holder (sections 8G, 9F and 11J refer). As a condition of a
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licence, licence holders must also notify the Secretary of any matter that may affect
whether they are still a fit and proper person to hold the licence or whether their
business associates are fit and proper persons to be associated with the licence holder
(sections 10K and 12N refer). Similarly, the Secretary must revoke a licence if
satisfied on reasonable grounds that the licence holder or a business associate of the
licence holder is not a fit and proper person (sections 10P and 13B refer).
Decisions to refuse to grant a licence, to revoke a licence and to impose conditions on
a licence are reviewable decisions under the Narcotic Drugs Act 1967 as recently
amended. An applicant or licence holder may, within 90 days, apply to the Minister
for a review of the decision by the Minister and, if not satisfied with the Minister's
decision, an application may be made to the Administrative Appeals Tribunal (the
AAT) for a review of that decision.
In order for the Secretary to consider whether an applicant or licence holder, or a
business associate, is a fit and proper person, the Narcotic Drugs Amendment Act
2016 includes powers for the Secretary to request information and documents from
Commonwealth agencies (such as the Australian Federal Police, and the Australian
Criminal Intelligence Commission), from state and territory agencies (including law
enforcement agencies) and other persons.
Commonwealth and state and territory law enforcement agencies, in particular, are
likely to hold information that could be relevant to the Secretary's consideration of
whether someone is a fit and proper person. However, if made available to that
person or to the public such information could reveal sensitive details of law
enforcement investigations or methodologies, including, for example, information
relating to human sources of intelligence in relation to criminal behaviour, controlled
operations, assumed identities or the use of coercive powers.
This Bill amends the Narcotic Drugs Act 1967 to include a definition of sensitive law
enforcement information as information that, if disclosed, could prejudice law
enforcement operations, intelligence collection or the safety of certain persons.
Amendments include important safeguards against the disclosure of such information
when the Act requires reasons to be given to an applicant or a licence holder in
relation to a decision under the Act. In such instances, the decision-maker (the initial
decision maker or the Minister or their delegate) would be precluded from giving
reasons to the extent that those reasons would disclose sensitive law enforcement
information.
This type of non-disclosure obligation exists in a number of state and territory
licensing regimes, where information relating to law enforcement of a sensitive nature
is used to assess licence applications, including licensing decisions under sections 45
and 144 of the Liquor Act 2007 (New South Wales), section 28A of the Liquor
Licensing Act 1997 (South Australia) and sections 22 and 57 of the Tattoo Parlours
Act 2013 (Queensland).
By ensuring that restrictions on the disclosure of sensitive law enforcement
information apply only to those aspects of the reasons that would reveal sensitive law
enforcement information, the amendments are designed to strike an appropriate
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balance between protecting law enforcement operations and intelligence and
upholding administrative law principles and requirements.
Where an applicant or licence holder applies to the Administrative Appeals Tribunal
for a review of a decision, the Bill includes a power for the Secretary to apply to the
AAT for the hearing of that matter, or part of that hearing, to take place in private, to
give directions in relation to persons who may be present and to give directions
prohibiting or restricting the publication or other disclosure of information in relation
to the review, including sensitive law enforcement information.
The AAT can make such orders if satisfied that to do so would be necessary to protect
specified purposes in relation to sensitive law enforcement information, or to protect
relevant persons and other relevant matters relating to the working of a law
enforcement agency and their methodologies.
In addition, the Bill will modify the operation of section 28 of the Administrative
Appeals Tribunal Act 1975 in its application to decisions under the Narcotic Drugs
Act 1967 (under which a person is entitled to request a statement of reasons from a
decision maker and seek review of a refusal), so that sensitive law enforcement
information is not required to be provided for that purpose. In addition, the Bill
provides that if the natural justice 'hearing rule' would, but for the provisions of
Narcotic Drugs Act 1967, require the disclosure of sensitive law enforcement
information, the Act is taken to be an exhaustive statement of the requirements of the
natural justice hearing rule in relation to the disclosure of that information.
The Bill also introduces an offence for the unauthorised disclosure of sensitive law
enforcement information by a person who has obtained that information in connection
with the performance of a function or an exercise of a power under the Narcotic
Drugs Act 1967. The offence does not apply in particular circumstances, including
where such disclosure is in compliance with a requirement of a law of the
Commonwealth or where the giver of the information to the Secretary consents to its
use or disclosure.
A small number of minor amendments are also made by this Bill to the Narcotic
Drugs Act 1967, including making it clear that cannabis research licence holders can
supply seeds to licensed cultivators, empowering the Minister to make standards and
guidelines, including additional grounds to refuse to grant a licence or a permit (if the
application contains information that is false or misleading in a material particular or
omits matter or thing without which the application is misleading in a material respect
and failure to pay any fee that has become payable), providing that a licence is not
transferable, allowing for the making of regulations to specify periods within which
the Secretary must notify licence holders of certain matters, providing for the timing
of the payments of fees and charges and allowing for the refund, waiving, reduction or
remission of fees.
Schedule 3 to the Bill provides for amendments relating to the payment of licence
charges. It will be a ground for the revocation of a licence if the charge is not paid
within 28 days after the due date. The Bill also provides for the making of regulations
for matters relating to the payment of charges, including the time and manner of
payment, and pro-rating, waiving, refunds, reduction or remission.
3
A small number of amendments are also made to the Therapeutic Goods Act 1989 to
allow regulations to be made setting out circumstances in which the Secretary must
not grant approvals to medical practitioners to prescribe unapproved therapeutic
goods for their patients. This will allow regulations to be made (if required) more
clearly setting out the circumstances in which the use of medicinal cannabis products
can be authorised.
Financial Impact Statement
The regulation of the cultivation licensing scheme for cannabis, to which these
amendments relate, will create some administration costs for the Government. It is
proposed that these be funded from a cost-recovery scheme consistent with the
Government's cost-recovery guidelines. Charging arrangements to recover the costs
of Commonwealth licensing for medicinal cannabis cultivation and production
licences, and cannabis research cultivation and production licences are proposed. This
proposal will introduce charging arrangements to recover the direct costs of
Commonwealth services for the approval of entities to cultivate and produce cannabis for
medicinal purposes, and for research purposes, known as the Medicinal Cannabis
Scheme. The revenue collected will be used to support the Scheme.
This proposal includes the making of regulations under the Narcotic Drugs Act 1967 (the
Act) to prescribe fees and under the proposed Narcotic Drugs (Licence Charges) Act
2016 to allow licence charges to be imposed on licences granted under the Act to support
the licensing scheme for the regulation of cannabis for medicinal and scientific use.
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Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny)
Act 2011
NARCOTIC DRUGS LEGISLATION AMENDMENT BILL 2016
This Bill is compatible with the human rights and freedoms recognised or declared in
the international instruments listed in section 3 of the Human Rights (Parliamentary
Scrutiny) Act 2011.
Overview of the Bill
Amendments to the Narcotic Drugs Act 1967 (the ND Act) are proposed to protect
'sensitive law enforcement information' that is provided to, or held by, the Secretary
of the Department of Health (the Secretary) for the purposes of making licensing
decisions under the ND Act. In addition, it would be an offence if a person who holds
sensitive law enforcement information obtained in connection with the performance
or exercise of a power under the ND Act discloses that information to another person
or uses the information. It would not be an offence if the disclosure or use of that
information is for a lawful purpose as specified under the Act.
Cannabis is an illicit drug with a high street value. The legal cultivation of cannabis
for medicinal purposes may be attractive to criminal elements looking to profit by
diverting some, or all, of the crop to illegal uses. In addition, prohibited substances
that are narcotic drugs that are authorised to be manufactured under the ND Act may
also be subject to this diversion risk.
It is essential to take all possible actions to preclude the infiltration of organised crime
into the medicinal cannabis framework or in the manufacture of narcotic drugs. This
will be supported through extensive background checks of the individuals involved in
cannabis cultivation and manufacturing enterprises. Some information will be
publicly available and easily accessible, such as conviction history and non-
compliance with requirements under the ND Act. However, other information may be
intelligence gathered by, and known only to, law enforcement agencies. These
amendments to the ND Act are proposed to give law enforcement agencies confidence
that they can share pertinent information and that it won't be released to the applicant
or to third parties, thus protecting ongoing criminal investigations and investigation
techniques.
Licensing decisions on the cultivation of cannabis plants, production of cannabis or
cannabis resins and the manufacture of drugs are underpinned by a 'fit and proper
person' test.
In implementing the licensing schemes (consisting of medicinal cannabis licences,
cannabis research licences and manufacture licences), the Bill enables the Secretary to
request information, documents or advice from Commonwealth agencies (including
the Australian Federal Police (AFP) and Australian Criminal Intelligence Commission
(ACIC)) and other persons (see section 14K of the ND Act). The Secretary can also
require the head of a state and territory agency to provide information or documents
relevant to such decisions (see section 14L). This information will assist in
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determining whether a person and their relevant business associates are fit and proper
persons for the purposes of making decisions on the granting, varying or cancelling a
licence in relation to that person.
Documents or advice provided to the Secretary that contain 'sensitive law
enforcement information' require mechanisms to protect this information from
inappropriate disclosure and use. Agencies would be unwilling to provide such
information and would not entrust such information to the Commonwealth if it could
be disclosed to the applicant or become public. Such disclosure could prejudice law
enforcement operations, endanger human safety or pose a risk to intelligence
collection.
The Bill provides a definition of sensitive law enforcement on which the operation of
protection for non-disclosure would be based. Sensitive law enforcement information
is information the disclosure of which is reasonably likely to prejudice Australia's law
enforcement interests, including Australia's interests in avoiding disruption to
national and international efforts relating to law enforcement, criminal intelligence
and criminal investigation etc.; protecting the technologies and methods use to collect,
analyse, use or otherwise deal with criminal and other related intelligence relating to
the integrity of law enforcement agencies; the protection and safety of persons such as
witnesses and informants; and ensuring that law enforcement agencies are not
discouraged from giving information to a nation's government and government
agencies. This definition is identical to the definition given in section 41(2) of the
Public Interest Disclosure Act 2013.
The Bill provides for the protection of sensitive law enforcement information from
disclosure in the statement of reasons for decisions where the decision maker has
relied on that information in making the decision.
Unsuccessful applicants and holders of licences whose licences have been suspended
or revoked can still seek review of those decisions in the Administrative Appeals
Tribunal (the AAT). However, the Bill allows for the Secretary to seek the protection
and non-disclosure of the sensitive law enforcement information in the AAT in such a
review. In addition, the Bill provides for additional grounds for consideration by the
AAT in making the order prohibiting disclosure of that information to the applicant
and his or her legal counsel and to the public at large. These additional grounds are
consistent with the definition of sensitive law enforcement information. Thus, the
AAT is able to evaluate whether any or all of the information sought to be protected is
sensitive law enforcement information and to make appropriate orders to protect that
information from disclosure.
The proposed amendments are intended to strike an appropriate balance between
ensuring procedural fairness is accorded to the applicant and protecting sensitive law
enforcement information from disclosure. The amendments would maintain an
applicant's access to review and the obligation to provide a statement of reasons, but
only to the extent that it does not disclose sensitive law enforcement information. The
limits imposed by the Bill are both reasonable and proportionate to achieve this
outcome.
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Human rights implications
Right to a fair trial/hearing - Article 14 of the ICCPR
The decisions in question relate to whether or not a person can hold a licence under
the Act to cultivate or produce cannabis or cannabis resin or manufacture drugs that
are covered by the Single Convention on Narcotic Drugs, 1961 and are administrative
in nature. Any use by such material in a court will be determined under the National
Security Information (Criminal and Civil Proceedings) Act 2004.
Article 14 of the International Covenant on Civil and Political Rights (ICCPR)
provides for the right to a fair and public criminal trial or a public hearing in civil
proceedings. Fair trial and fair hearing rights provide that all persons are equal before
courts and tribunals, and have the right to a fair and public hearing before a
competent, independent and impartial court or tribunal established by law. The right
to a fair trial applies to both criminal and civil proceedings and in cases before both
courts and tribunals. The right is concerned with procedural fairness, rather than with
the substantive decision of a court or tribunal. What constitutes a fair hearing will
require recognition of the interests of all parties in a civil proceeding. The procedures
followed in a hearing should respect the principle of 'equality of arms', which
requires that all parties to a proceeding must have a reasonable opportunity of
presenting their case under conditions that do not disadvantage them as against other
parties to the proceedings.
Restricting the disclosure of sensitive law enforcement information to applicants or
licence holders would provide for the integrity of the medicinal cannabis framework
and manufacture of narcotic drugs framework by ensuring that persons who have
criminal histories or who are involved in organised crimes, or those associated with
such persons, would not be able to hold a licence.
The protection of sensitive law enforcement information in the Bill is therefore
necessary to protect the integrity of these frameworks. The protection is also
proportionate as it strikes a balance between how it achieves this purpose and the
negative effect that restrictions on disclosure could have on the ability of a person to
respond to the case against them.
The offence provision on unauthorised disclosure and use does not derogate from the
requirements of Article 14, in particular Article 14(2), which provides that everyone
charged with a criminal offence shall have the right to be presumed innocent until
proven guilty according to law.
Conclusion
This Bill is compatible with human rights as it does not raise any human rights issues.
The Hon Sussan Ley MP, the Minister for Health and Aged Care/Minister for
Sport
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NARCOTIC DRUGS LEGISLATION AMENDMENT BILL 2016
NOTES ON CLAUSES
Clause 1 - Short title
This clause provides that the Bill, once enacted, may be cited as the Narcotic Drugs
Legislation Amendment Act 2016.
Clause 2 - Commencement
This clause provides that sections 1 and 3, and anything in the Bill not covered
elsewhere in the table in clause 2, will commence on Royal Assent.
Schedules 1 and 2 commence on the later of the day the Bill receives Royal Assent or
immediately after the commencement of Schedule 1 to the Narcotic Drugs
Amendment Act 2016.
This will ensure that the amendments in these Schedules, which principally relate to
changes to the Narcotic Drugs Act 1967 to protect sensitive law enforcement
information and a number of other, mostly minor, amendments to the scheme for the
regulation of medicinal cannabis (but which also includes a small number of changes
to the Therapeutic Goods Act 1989 in Schedule 2), will commence at the same time as
the other parts of that scheme.
Schedule 3 commences on the later of the day the Bill receives Royal Assent or
immediately after the commencement of section 1 of the Narcotic Drugs (Licence
Charges) Act 2016. The amendments in Schedule 3 would make a small number of
minor amendments to the Narcotic Drugs Act 1967 to reflect the proposed making of
the Narcotic Drugs (Licence Charges) Act 2016, which is expected to be introduced
into Parliament with this Bill.
Clause 3 - Schedules
This clause provides that each Act that is specified in a Schedule to this Bill is
amended or repealed as set out in the applicable items in the Schedule concerned and
any other item has effect according to its terms.
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SCHEDULE 1 -- AMENDMENT RELATING TO SENSITIVE LAW
ENFORCEMENT INFORAMTION
Narcotic Drugs Act 1967
The amendments in this Schedule principally relate to the protection of sensitive law
enforcement information provided by Commonwealth and state and territory law
enforcement agencies to the Secretary of the Department of Health, or held by the
Secretary in their own right from other sources, relevant to the making of decisions in
relation to licences under the Narcotic Drugs Act 1967.
Item 1 - Subsection 4(1)
This item amends subsection 4(1) of the Narcotic Drugs Act 1967 to include new
definitions, of 'law enforcement agency' and 'sensitive law enforcement information'.
The former is consistent with the definition of Australian law enforcement or
intelligence agency in section 503A of the Migration Act 1958. Additional bodies can
be prescribed in the regulations. The Australian Crime and Intelligence Commission
(ACIC), the Australian Federal Police (the AFP) and state and territory police forces
would be covered by this definition.
The definition covers bodies, agencies and organisations responsible for, or that deal
with, the areas of law enforcement, criminal intelligence or investigation, fraud or
security intelligence.
The definition of 'sensitive law enforcement information' is the same as that used in
the Public Interest Disclosure Act 2013 and is consistent with the definitions use in
the National Security Information (Criminal and Civil Proceedings) Act 2004 to
describe the kind of information protected under that Act.
By reason of this definition the measures elsewhere in this Bill relating to the
identification and protection of sensitive law enforcement information will cover
information the disclosure of which is reasonably likely to prejudice Australia's law
enforcement interests. This includes Australia's interests in:
avoiding disruption to national and international law enforcement, criminal
intelligence and investigations, foreign intelligence, security intelligence or the
integrity of law enforcement agencies;
safeguarding the technologies and methods employed to gather, analyse, secure
or otherwise deal with intelligence relating to criminal, foreign or security
intelligence or intelligence relating to the integrity of law enforcement agencies;
the protection and safety of informants or witnesses, persons associated with
informants or witnesses and persons involved in the protection and safety of
informants or witnesses; and
ensuring that intelligence and law enforcement agencies are not discouraged
from providing information to a nation's government and government agencies.
Items 2 and 3 - Paragraph 11(2)(a) and after paragraph 11(2)(a)
These items would make minor consequential amendments to subsection 11(2) of the
Narcotic Drugs Act 1967 to reflect the new subsection 11(5).
9
Item 4 - At the end of section 11
New section 11 of the Narcotic Drugs Act 1967 requires the Secretary to notify the
holder of a cannabis licence or a cannabis permit if the Secretary proposes to revoke
the licence or permit. That notice must give details of the proposed revocation and
the reasons and invite the holder to make written submissions about the proposed
action. Under new subsection 11(4), the Secretary must have regard to such
submissions in considering whether to revoke the licence or permit.
Item 4 adds a new subsection 11(5), which would have the effect of precluding the
Secretary from disclosing, as part of the reasons for a proposed revocation, any
information identified as sensitive law enforcement information identified under
subsections 14LA(1) or (2) (item 10 below refers).
This would cover information identified as sensitive law enforcement information by
a person or agency head when giving that information to the Secretary in accordance
with subsection 14LA(1) and information in the possession of the Secretary that the
Secretary knows or believes is sensitive law enforcement information as provided by
new subsection 14LA(2).
If the Secretary has relied on information identified under subsection 14LA(1) in
relation to the revocation, new subsection 11(5) would require the Secretary to consult
the giver of the information before giving notice of the proposed revocation.
Items 5 and 6 - Paragraph 13(2)(a) and after paragraph 13(2)(a)
These items would make minor consequential amendments to subsection 13C(2) of
the Narcotic Drugs Act 1967 to reflect the new subsection 13C(5).
Item 7 - At the end of section 13C
New section 13C of the Narcotic Drugs Act 1967 requires the Secretary to notify the
holder of a manufacture licence or permit if the Secretary proposes to revoke the
licence or permit. That notice must give details of the proposed revocation and the
reasons for it and invite the holder to make written submissions about the proposed
action. Under new subsection 13C(4), the Secretary must have regard to such
submissions in considering whether to revoke the licence or permit.
Item 7 adds a new subsection 13C(5), which would have the effect of precluding the
Secretary from disclosing, as part of the reasons for a proposed revocation of a
holder's manufacture licence or permit, any information identified as sensitive law
enforcement information under subsections 14LA(1) or (2) (item 10 below refers).
If the Secretary has relied on information identified under subsection 14LA(1) in
relation to the revocation, new subsection 13C(5) would require the Secretary to
consult the giver of the information before giving notice of the proposed revocation.
Item 8 - At the end of section 14K
Item 8 adds a new subsection 14K(3), that provides that section 14K (under which the
Secretary can request information from any source, including the Commonwealth) is
not limited by section 14L (under which the Secretary can require the head of a State
or Territory agency to give the Secretary information or documents).
10
This makes it clear that the reference to 'any source' in section 14K extends to state
and territory agencies and that the Secretary can request information from a state or
territory agency under that section.
Item 9 - After subsection 14L(3)
Section 14L of the Narcotic Drugs Act 1967 allows the Secretary to, by written
notice, require the head of a state or territory agency to give the Secretary information
or documents that are relevant to an application for a licence or permit or to a
variation or revocation of a licence or permit, or information or documents that
otherwise relate to a licence or permit. Under subsection 14L(3), any agency head
who receives such a notice must comply with it as soon as is practicable and must
comply to the extent that they have - or can reasonably acquire - the information or
documents in question.
Item 9 now adds a new subsection 14L(3A) to this provision, that provides that the
head of such an agency is not obliged to comply to the Secretary's request for
information if the holder of the information has advised the agency head that the
holder knows or believes that the information in question is sensitive law enforcement
information and if the agency head so informs the Secretary. This allows a state or
territory law enforcement agency the discretion not to provide sensitive law
enforcement information where, for instance, the judgement is made that in the
particular circumstances it would not be appropriate to do so.
.
Item 10 - After section 14L
Item 10 introduces a new section 14LA to the Narcotic Drugs Act 1967 in relation to
the identification of sensitive law enforcement information in specified circumstances.
New subsection 14LA(1) has the effect that if the Secretary:
requests a Commonwealth or state or territory law enforcement agency to give
the Secretary information, documents or advice under section 14K of the
Narcotic Drugs Act 1967; or
requires the head of a state or territory agency that is a law enforcement agency
to give the Secretary information or documents under section 14L,
the person or agency head must, at the time of giving the information or subsequently,
identify any such information that they know or believe to be sensitive law
enforcement information.
New subsection 14LA(2) has the effect that if the Secretary has information that has
not been provided by a Commonwealth, state or territory law enforcement agency and
the Secretary knows or believes that the information is sensitive law enforcement
information, the Secretary must identify the information as such.
Item 11 - Before section 14N
Item 11 introduces a new offence (section 14MA) to the Narcotic Drugs Act 1967
relating to the unauthorised disclosure of sensitive law enforcement information.
Under new subsection 14MA(1), a person commits an offence if they disclose or use
information obtained in connection with the performance of a function or the exercise
of a power under the Narcotic Drugs Act 1967 that is information identified as
11
sensitive law enforcement information under subsections 14LA(1) or (2). The
maximum penalty is imprisonment for 2 years or 120 penalty units, or both.
Subsection 14MA(2), however, makes it clear that subsection 14MA(1) does not
apply if:
the disclosure or use is for the purposes of or in connection with the
performance of a function or the exercise of a power under the Narcotic Drugs
Act 1967, or in compliance with a law of the Commonwealth; or
the person or the agency who provided the information to the Secretary has
consented to the use or disclosure; or
the disclosure or use is required by a court or tribunal in proceedings to give
effect to the Narcotic Drugs Act 1967 or another law of the Commonwealth; or
the information was in information, or a document or advice that was given to
the Secretary under section 14K or 14L and the use or disclosure is by that
person or that agency.
Item 12 - Section 14N
This item makes a minor amendment to section 14N of the Narcotic Drugs Act 1967,
which lists authorised disclosures of information, to make it clear that the list of those
disclosures is subject to the operation of new section 14MA.
Item 13 - Paragraph 14N(f)
This item makes a minor consequential amendment to reflect the inclusion of the
definition of 'law enforcement agency' by item 1.
Items 14 and 15 - Paragraph 15F(1)(b) and paragraph 15F(2)(e)
These items would make minor consequential amendments to section 15F of the
Narcotic Drugs Act 1967 to reflect the new subsection 15F(2A).
Item 16 - After subsection 15F(2)
Subsection 15E(1) of the Narcotic Drugs Act 1967 lists decisions of the Secretary
under that Act that are reviewable decisions. These include, for example, a decision
to refuse to grant a licence or permit, to impose conditions on a medicinal cannabis
licence or cannabis research licence, and decisions to refuse to grant, or to impose
conditions on, a manufacture licence.
Under section 15G of the Narcotic Drugs Act 1967, an applicant for, or a holder of, a
licence or permit affected by one of these decisions can apply to the Minister for a
review of the decision and can also apply to the AAT for a review of the Minister's
(or his or her delegate's) decision (section 15L refers).
Under subsection 15F(1) of the Narcotic Drugs Act 1967, the person who makes the
initial, reviewable decision must give the applicant or holder affected a written notice
setting out the terms of the decision, the reasons and the applicant's or holder's review
rights. In addition to giving a written notice under subsection 15F(1), the decision
maker in specified circumstances, is also required to give a notice of the decision to
the head of a state or territory agency setting out the terms of the decision, the reasons
and the right of the agency to have the decision reviewed.
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This item amends section 15F by inserting a new subsection (2A) with the effect of
precluding a decision-maker under section 15F from disclosing in any such notice any
information identified as sensitive law enforcement information under subsection
14LA(1) or (2).
If the Secretary has relied on information identified under subsection 14LA(1) in
making the decision, new subsection 15F(2A) would require the Secretary to consult
the giver of the information before giving notice of the decision.
Item 17 - Paragraph 15J(1)(b)
This item makes a minor consequential amendment to paragraph 15J(1)(b) of the
Narcotic Drugs Act 1967 to reflect the new subsection 15J(4).
Item 18 - At the end of section 15J
Under section 15H of the Narcotic Drugs Act 1967, where the Minister receives an
application for the review of a reviewable decision, the Minister must either review
that decision themselves personally, or arrange for a delegate to undertake that
review.
Under section 15J of the Narcotic Drugs Act 1967, after a decision has been made
under section 15H, the Minister or delegate must give the applicant for review a
notice setting out the terms of the review decision (i.e. the decision that the Minister
or delegate has reached on reviewing the initial, reviewable decision). This notice
must set out the terms of the review decision, the reasons for it, and the applicant's
rights to have the review decision reviewed by the AAT.
This item amends section 15J by inserting a new subsection (4), with the effect of
precluding the Minister or delegate from disclosing, in relation to the giving of
reasons for a review decision, any information identified as sensitive law enforcement
information under subsections 14LA(1) or (2).
If the Minister or their delegate has relied on information given under subsection
14LA(1) in making the decision, new subsection 15J(4) would require them to consult
the giver of the information before giving notice of the decision.
Item 19 - At the end of Part 4 of Chapter 4
This item adds new section 15M to Chapter 4 of the Narcotic Drugs Act 1967 in
relation to appeals to the AAT for the review of a review decision.
This provision makes it clear that in the event that a person applies to the
Administrative Appeals Tribunal for a review of a decision by the Minister or their
delegate, the Secretary can, at any time, ask the Tribunal to make orders of the kind
referred to in section 35 of the Administrative Appeals Tribunal Act 1975 (AAT Act)
in relation to such proceedings.
The kinds of orders that can be requested by the Secretary include orders directing a
hearing or part of a hearing to take place in private, orders about the persons who may
attend a hearing and orders prohibiting or restricting the publication or disclosure of
information relating to the AAT's review of the matter. Such information includes,
13
but is not limited to, information identified as sensitive law enforcement information
under subsections 14LA(1) or (2) of the Narcotic Drugs Act 1967.
If the Secretary asks for such an order and the Tribunal is satisfied that the order is
necessary:
(a) in the interests of avoiding disruption to (among other things) national and
international law enforcement efforts, criminal intelligence or investigations or
security intelligence; or
(b) in the interests of protecting law enforcement agencies' technologies and
methods; or
(c) to protect and ensure the safety of informants or witnesses, or persons
associated with , or persons involved in the protection or safety or informants
or witnesses; or
(d) or to ensure that intelligence and law enforcement agencies are not
discouraged from giving information to a nation's government and
government agencies,
then the Tribunal may make the order requested by the Secretary.
This item also adds new section 15N to Chapter 4 of the Narcotic Drugs Act 1967 in
relation to the identification of information as sensitive law enforcement information
in the context of a review by the AAT.
The new provision applies if a person asks the Tribunal to review a decision of the
Minister or delegate that relates to a reviewable decision under the Narcotic Drugs
Act 1967.
New subsection 15N(2) provides that the person is not entitled to make a request for a
statement of reasons under subsection 28(1) of the AAT Act merely because a
document or statement referred to in subsection 28(4) of the AAT Act does not
include information identified as sensitive law enforcement information under
subsection 14LA(1) or (2) of the Narcotic Drugs Act 1967.
New subsection 15N(3) provides that if, notwithstanding subsection 15N(2), the
person is entitled to make a request under subsection 28(1) (for instance because the
relevant document or statement referred to in subsection 28(4) does not contain
information evidence or material on which findings of fact were based but which is
not sensitive law enforcement information), then: the statement provided under
subsection 28(1) is not required to include information identified as sensitive law
enforcement information; the person is not entitled to be given such information; and
the absence of that information may not be used as a basis for the AAT to regard the
statement as inadequate for the purposes of subsection 28(5) of the AAT Act.
Item 20 - After section 21
This item adds new section 21A to Part III of the Narcotic Drugs Act 1967 in relation
to the operation of the natural justice 'hearing rule'. The hearing rule requires that a
decision maker inform the person about matters adverse to them and provide the
opportunity to be heard (i.e. for the person to respond to those matters) before the
decision is made.
14
New section 21A provides that if, but for the requirements of the Narcotic Drugs Act
1967, the natural justice hearing rule would require the disclosure of information
identified as sensitive law enforcement information under subsections 14LA(1) or (2),
then the Act itself is taken to be an exhaustive statement of the requirements of the
rule in relation to the disclosure of that information.
This measure is intended for consistency with the provisions relating to non-
disclosure of sensitive law enforcement information, and to ensure that the natural
justice hearing rule does not undermine the safeguards in the Narcotic Drugs Act 1967
in relation to the non-disclosure of sensitive law enforcement information.
Thus, the non-disclosure of that information to a person adversely affected by a
decision would not result in the decision being found by a court to be unlawful even
though the person was not made aware of the information prior to the decision being
made.
Both of these provisions provide significant support to the integrity of the protection
accorded to sensitive law enforcement information. The process for the granting of
licences under the ND Act must ensure that the persons who hold a licence, their
business associates and their employees would be able to carry out those activities
without any risks of illicit purposes and diversion. Without the assistance of law
enforcement agencies, relevant information to support that objective may not be
available to the decision maker.
Item 21 - At the end of section 25
Section 25 of the Narcotic Drugs Act 1967 allows the Health Minister and the
Secretary to delegate their powers and functions under that Act.
This item adds new subsection 25(5), which would have the effect of precluding the
Secretary from delegating a power or a function under subsection 14LA(2)
(identifying sensitive law enforcement information in the context of information given
to the Secretary by a person other than a Commonwealth, state or territory law
enforcement agency) to any person other than an SES employee or acting SES
employee in the Department of Health and Aged Care.
This ensures that consideration of whether information is of the kind referred to in the
definition of sensitive law enforcement information (and thus subject to restrictions on
use and disclosure under the Act) is undertaken by a senior officer within the
Department.
15
SCHEDULE 2 - OTHER AMENDMENTS
Part 1 - Amendments relating to timing of notification of certain matters
Narcotic Drugs Act 1967
Items 1 - 3 - Section 10K and at the end of section 10K
Section 10K of the Narcotic Drugs Act 1967 provides that it is a condition of a
cannabis licence that the licence holder notify the Secretary as soon as reasonably
practicable if any of the matters listed in subsections 10K(a)-(d) occur (e.g. a breach
of the licence).
Item 1 makes a minor, consequential amendment to section 10K in order to
accommodate the changes made by items 2 and 3.
Items 2 and 3 replace the current requirement for a licence holder to notify the
Secretary of any of the matters in 10K(a)-(d) 'as soon as reasonably practicable' with
a requirement to do so within any period prescribed in regulations for the purposes of
new subsection 10K(2) or, if no such period is prescribed, as soon as reasonably
practicable after the matter comes to the licence holder's attention.
This will remove ambiguity around what is meant by 'as soon as reasonably
practicable', and remove discretion from the licence holder for matters where it is
deemed important enough that the Commonwealth is notified within a defined period,
such as an event involving diversion of narcotic drugs.
Items 4-6 Section 12N and at the end of section 12N
Section 12N of the Narcotic Drugs Act 1967 provides that it is a condition of a
manufacture licence that the licence holder notify the Secretary as soon as reasonably
practicable after any of the matters listed in subsections 12N(a)-(d) occur (e.g. a
breach of the licence).
Item 1 makes a minor, consequential amendment to section 12N in order to
accommodate the changes made by items 2 and 3.
Item 2 and 3 replace the current requirement for a licence holder to notify the
Secretary of any of the matters in 12N(a)-(d) 'as soon as reasonably practicable' with
a requirement to so within any period prescribed in regulations for the purposes of
new subsection 12N(2) or, if no such period is prescribed, as soon as reasonably
practicable after the matter comes to the licence holder's attention.
As above, this addresses ambiguity with the term 'as soon as reasonably practicable'.
Part 2 - Amendments relating to guidelines and standards
Narcotic Drugs Act 1967
16
Items 7 and 8 - Subsection 4(1)
These items add the following new definitions to subsection 4(1) of the Narcotic
Drugs Act 1967 to reflect new powers for the Minister to issue guidelines and
standards (item 28 below refers):
'guidelines', meaning guidelines issued by the Minister under section 26C of
that Act; and
'standards', meaning standards issued by the Minister under section 26B of that
Act.
Item 9 - At the end of section 8F
Section 8F of the Narcotic Drugs Act 1967 requires that, where a person has applied
for a cannabis licence, the Secretary must decide whether to grant or refuse that
application. Subsection 8F(3) sets out matters which the Secretary must or may have
regard to in making that decision.
This item inserts a note after at the end of the section with the effect of making it clear
that the Secretary must also have regard to any applicable guidelines issued under new
section 26C (item 28 below refers).
Item 10 - After paragraph 8G(1)(e)
Section 8G of the Narcotic Drugs Act 1967 sets out circumstances in which the
Secretary must refuse to grant a cannabis licence, for example, if the Secretary is not
satisfied on reasonable grounds that the applicant is a fit and proper person to hold
such a licence.
This item amends section 8G to add a new such ground being where the Secretary is
not satisfied on reasonable grounds that the standards applying to the licence have
been or will be met.
Items 11- After paragraph 9(4)(a)
New section 9 of the Narcotic Drugs Act 1967 requires that, where a person has
applied for a cannabis permit, the Secretary must decide whether to grant or refuse
that application. Subsection 9(2) provides that the Secretary may, subject to
subsections 9(3) and (4), grant a cannabis permit if he or she considers it appropriate
in all the circumstances to do so.
Item 11 would make an amendment to section 9 under subsection (4) to add two new
grounds on which the Secretary must refuse to grant a cannabis permit, being:
if the Secretary is not satisfied on reasonable grounds that any standards
applicable to the permit have been, or will be met; and
the Secretary is satisfied on reasonable grounds that one or more circumstances
exist that are prescribed by the regulations made for the purposes new paragraph
9(4)(ab).
Item 12 - At the end of section 9
Item 12 includes a note at the end of section 9 to the effect that the Secretary must
have regard to any applicable guidelines (item 28 below refers).
17
Item 13 - At the end of section 9E
Section 9E of the Narcotic Drugs Act 1967 requires that, where a person has applied
for a cannabis research licence, the Secretary must decide whether to grant or refuse
that application. Subsection 9E(3) sets out matters which the Secretary must, or may,
have regard to in making that decision.
Item 13 inserts a note at the end of section 9E, with the effect of making it clear that
the Secretary must also have regard to any applicable guidelines issued under new
section 26C (item 28 below refers).
Item 14 - After paragraph 9F(1)(e)
Section 9F of the Narcotic Drugs Act 1967 sets out circumstances in which the
Secretary must refuse to grant a cannabis research licence.
This item amends section 9F to add a new ground under new paragraph (ea) being
where the Secretary is not satisfied on reasonable grounds that the standards applying
to the licence have been or will be met.
Items 15 and 16 - After paragraph 9P(4)(a) and at the end of section 9P
New section 9P of the Narcotic Drugs Act 1967 requires that, where a person has
applied for a cannabis research permit, the Secretary must decide whether to grant or
refuse that application. Subsection 9P(2) provides that the Secretary may, subject to
subsections 9P(3) and (4), grant a cannabis permit if he or she considers it appropriate
in all the circumstances to do so.
Item 15 adds two new grounds on which the Secretary must refuse to grant a cannabis
research permit, being:
if the Secretary is not satisfied on reasonable grounds that any standards
applicable to the research permit have been, or will be, met; and
if the Secretary is satisfied on reasonable grounds that one or more
circumstances exist that are prescribed by the regulations made for the purposes
new paragraph 9P(4)(ab).
Item 16 includes a note after subsection 9P, making it clear that the Secretary must
also have regard to any applicable guidelines issued by the Minister under new section
26C (item 28 below refers).
Item 17 - Paragraph 10D(1)(p)
Section 10D of the Narcotic Drugs Act 1967 relates to conditions of cannabis licences
and lists matters to which conditions that are either imposed by the Secretary or that
are prescribed in regulations may relate to - e.g. the facilities and containment relating
to the cultivation or production authorised by a licence and the safety, security and
surveillance of that land and premises.
Under the current paragraph 10D(1)(p), one such matter is compliance with a code of
practice, a technical or procedural guideline or a prescribed quality standard.
This item substitutes a new paragraph 10D(1)(p), to replace these references with a
reference to compliance with a code of practice alone. This is because requirements
18
to quality standards are already covered in other provisions relating to compliance
with standards and guidelines.
Item 18 and Item 19 - After paragraph 10P(2)(g) and at the end of subsection
10P(2)
Subsection 10P(2) of the Narcotic Drugs Act 1967 sets out circumstances in which the
Secretary can revoke a cannabis licence, or a cannabis permit to which such a licence
relates, for example, if the Secretary is satisfied on reasonable grounds that a
condition of the licence has been breached.
Item 18 amends section 10P to add a new such circumstance (at new paragraph
10P(2)(ga)) on which the Secretary would have the discretion to revoke a cannabis
licence or related permit - being, where the Secretary is satisfied on reasonable
grounds that standards that are applicable to the licence or permit have not been met.
Item 19 adds a note that provides that the Secretary must have regard to any
applicable guidelines (Item 28 refers).
Item 20 - At the end of section 11H
Section 11H of the Narcotic Drugs Act 1967 requires that, where a person has applied
for a manufacture licence, the Secretary must decide whether to grant or refuse that
application. Subsection 11H(2) provides that the Secretary may, subject to sections
11J and 11K, grant a manufacture licence if he or she considers it appropriate in all
the circumstances to do so.
Subsection 11H(3) sets out matters that the Secretary must, or may, have regard to in
making that decision.
Item 20 inserts a note after paragraph 11H(3)(b) of that Act with the effect of making
it clear that the Secretary must also have regard to any applicable guidelines issued
under new section 26C (item 28 below refers).
Item 21 - After paragraph 11J(1)(e)
Section 11J of the Narcotic Drugs Act 1967 lists grounds in which the Secretary must
refuse to grant a manufacture licence.
This item would amend section 11J to add a new such ground, being where the
Secretary is not satisfied on reasonable grounds that standards applicable to the
licence have been or will be met. This ground will be set out in new paragraph
11J(1)(ea).
Item 22 - Subsection 11K(2)
Section 11K applies to an application for a manufacture licence that will authorise the
manufacture of a drug that includes, or is from any part of, the cannabis plant.
Subsection 11K(2) (unintentionally) provides that the Secretary must refuse to grant
the licence if the Secretary is not satisfied on reasonable grounds in relation to any
one of the circumstances set out in paragraphs (a) to (c).
The amendment would have an effect of amending the application of subsection
11K(2) to the effect the Secretary must refuse to grant the manufacture licence unless
19
the Secretary is satisfied on reasonable grounds of at least one of the grounds set out
in paragraphs (a) to (c). This was the original intention, and the amendment corrects a
drafting error.
Items 23 and 24- After paragraph 12A(4)(a) and at the end of section 12A
Section 12A of the Narcotic Drugs Act 1967 requires that, where a person has applied
for a manufacture permit, the Secretary must decide whether to grant or refuse that
application. Subsection 12A(2) provides that the Secretary can, subject to subsections
12A(3) and (4), grant a manufacture permit if the Secretary considers it appropriate in
all the circumstances to do so.
Item 23 would add two new grounds on which the Secretary must refuse to grant a
permit, being:
if the Secretary is not satisfied on reasonable grounds that any standards
applicable to the permit have, or will be, met; and
if the Secretary is satisfied on reasonable grounds that one or more
circumstances exist that are prescribed by the regulations made for the purposes
new paragraph 12A(4)(ab).
Item 24 inserts a note after subsection 12A(2), with the effect of making it clear that
the Secretary must also have regard to any applicable guidelines issued under new
section 26C (item 28 below refers).
Item 25 - Paragraph 12F(p)
Section 12F of the Narcotic Drugs Act 1967 relates to conditions of manufacture
licences and lists matters to which conditions that are either imposed by the Secretary
or that are prescribed in regulations may relate to - e.g. waste disposal, and the use of
names or symbols that may suggest or imply a particular effect upon humans of a drug
or narcotic preparation that contains cannabis or cannabis resin.
Under the current new paragraph 12F(p), one such matter is compliance with a code
of practice or a technical or procedural guideline.
This item substitutes a new paragraph 12F(p) to replace these references with a
reference simply to compliance with a code of practice alone. This is because
compliance with guidelines is covered in other provisions.
Items 26 and 27 - After paragraph 13B(2)(g) and at the end of subsection 13B(2)
Section 13B of the Narcotic Drugs Act 1967 provides for the revocation of a
manufacture licence or a manufacture permit relating to that licence. Subsection
13B(2) of the sets out circumstances in which the Secretary may revoke a
manufacture licence or a manufacture permit to which such a licence relates, e.g. if
the Secretary is satisfied on reasonable grounds that a condition of the licence has
been breached.
Item 26 amends section 10P to add a new such circumstance (at new paragraph
13B(2)(ga)) in which the Secretary would have the discretion to revoke a manufacture
licence or related permit being where the Secretary is satisfied on reasonable grounds
that standards that are applicable to the licence or permit have not been met.
20
Item 27 inserts a note after subsection 13B(2), with the effect of making it clear that
the Secretary must also have regard to any applicable guidelines issued under new
section 26C (item 28 below refers).
Item 28 - After section 26A
This item would add new section 26B to the Narcotic Drugs Act 1967 to give the
Minister the power to make a legislative instrument setting out standards for the
purposes of that Act - for example, that the Secretary must have regard to in deciding
matters such as whether to refuse to grant a cannabis licence. Standards are
mandatory requirements.
New subsection 26B(2) would make it clear that, despite section 14 of the Legislation
Act 2003, such standards instruments may make provision in relation to a matter by
applying, adopting or incorporating any matter contained in an instrument or other
writing as in force or as existing from time to time.
This item would also add new section 26C to the Narcotic Drugs Act 1967 to give the
Minister the power to issue guidelines for the purposes of that Act - for example, that
the Secretary must have regard to in deciding whether to grant or refuse an application
for a manufacture licence. New subsection 26C(2) provides that a person who
performs a function or exercises a power under this Act must have regard to any
guidelines that are applicable.
New subsection 26C(3) would make it clear that such guidelines are not legislative
instruments.
New subsection 26C(4) enables the guidelines to make provisions in relation to a
matter by applying, adopting or incorporating any matter contained in an instrument
or other writing as in force or existing from time to time. Thus it can refer to
documents as amended from time to time.
Item 29 - Paragraph 27(4)(c)
This item would repeal paragraph 27(4)(c). This is because the making of standards is
now provided for under new section 26B.
Part 3 - Amendments relating to the supply of seeds
Narcotic Drugs Act 1967
Item 30 - After subparagraph 9D(1)(c)(i)
New section 9D of the Narcotic Drugs Act 1967 sets out the matters that can be
authorised by a cannabis research licence.
This item would add a new matter under paragraph 9D(1)(c) being the supply of
cannabis plants to the holder of a cannabis licence or cannabis research licence that
authorises the cultivation of cannabis plants. This is to ensure that there is clear
authority to supply seeds to licensed cultivators. The research activity may produce
highly sought after varieties that may be of significant use by other licensed
cultivators.
21
Part 4 - Miscellaneous amendments
Narcotic Drugs Act 1967
Item 31 - Subsection 4(1) (definition of drug)
This item would make a change to the definition of drug in subsection 4(1) of the
Narcotic Drugs Act 1967 to allow for substances to be included by regulation.
Item 32 - Subsection 7A(1)
Item 32 amends subsection 7A(1) to insert the words '(whether expressly or
impliedly)' after the word 'purports'.
Section 7A makes clear Parliament's intention that section 25A (under which state
and territory agencies can be authorised to undertake the cultivation, production of
cannabis or cannabis resins and manufacture of medicinal cannabis) and Chapter 2
(which deals with the licensing of the cultivation and production of cannabis) are
intended to apply to the exclusion of certain state and territory laws.
These are laws that 'purport' to allow the cultivation of cannabis plants or the
production of cannabis or cannabis resins for medicinal or related scientific purposes
(whether by the grant of a licence, authorisation or otherwise) or prohibit an activity
or prevent a person from engaging in activity that is authorised under section 25A or
Chapter 2 or related provisions. Such a law will be ineffective to the extent that it
purports to do so.
Some state and territory laws may not expressly provide for the authorising of the
cultivation of cannabis plants for the production of cannabis or cannabis resins for
medicinal purposes or related scientific purpose. Rather, they may generally authorise
the cultivation of cannabis for a commercial or general research purpose. Further,
they may not expressly prohibit activities relating to cultivation and production for
medicinal purposes or for related scientific purposes.
The proposed change to subsection 7A(1) inserting the phrase '(whether expressly or
impliedly)' would make such a law ineffective to the extent that it is able to authorise
the cultivation of cannabis for the production of cannabis or cannabis resins for
medical purposes or for related scientific purposes whether that law does so expressly
or by implication.
Items 33 and 34 - Section 8C (heading) and section 8C
Section 8C of the Narcotic Drugs Act 1967 sets out the intended relationship between
provisions in the Act and the operation of Part VIIC of the Crimes Act 1914. The
section was intended to make clear that a person is not obliged to disclose information
about previous convictions in relation to licence applications etc. under the Narcotic
Drugs Act 1967 (noting that the regulations made for the purposes of section 85ZZH
of the Crimes Act can allow for exceptions in particular circumstances and these, if
applicable, would be relevant for the purposes of the Narcotic Drugs Act 1967).
22
These items make minor amendments to the heading of section 8C and to the section
itself to make it clear that nothing in the Act itself is intended to affect the operation
of Part VIIC.
Item 35 - Paragraph 8G(1)(g)
Subsection 8G(1) provides the circumstances in which the Secretary must refuse to
grant a licence.
Item 35 amends paragraph 8G(1)(g) to make it clear that the licence can be refused if
any fee that is payable has not been paid. This would include a fee payable in relation
to an inspection undertaken by the Commonwealth for the purposes of considering the
licence application.
Items 36 and 37 - After paragraphs 8G(1)(g) and before 9(4)(b)
Section 8G provides the general circumstances in which the Secretary must refuse to
grant a medicinal cannabis licence.
Item 36 amends subsection 8G(1) to add a new ground for refusing a licence. New
paragraph (ga) would require the Secretary to refuse to grant a licence if the Secretary
is satisfied on reasonable grounds that the application for the licence contains
information, or information has been given by the applicant in relation to the
application, that is false or misleading in a material particular or omits any matter or
thing without which the application is misleading in a material respect.
Section 9 provides for the making of a decision in relation to an application for a
medicinal cannabis permit. Subsection 9(4) provides for the grounds in which the
Secretary must refuse to grant a medicinal cannabis permit.
Item 37 inserts a new paragraph 9(4)(ac) that would require the Secretary to refuse to
grant a permit if the Secretary is satisfied on reasonable grounds that the application
for the permit contains information or information has been given by the applicant,
that is false or misleading in a material particular or omits any matter or thing without
which the application is misleading in a material respect
Item 38 - Paragraph 9F(1)(g)
Section 9F provides the general circumstances in which the Secretary must refuse to
grant a cannabis research licence.
Item 38 amends paragraph 9F(1)(g) to make it clear that the licence can be refused if
any fee that is payable has not been paid. This would include a fee payable in relation
to an inspection undertaken by the Department for the purposes of considering the
licence application.
Item 39 and 40 - After paragraph 9F(1)(g) and before 9P(4)(b)
Section 9F sets out the general circumstances in which the Secretary must refuse to
grant a cannabis research licence.
Item 39 inserts a new paragraph 9F(1)(ga) that would require the Secretary to refuse
to grant a licence if the Secretary is satisfied on reasonable grounds that the
application for the licence contains information, or information has been given by the
23
applicant in relation to the application, that is false or misleading in a material
particular or omits any matter or thing without which the application is misleading in
a material respect.
Section 9P provides for the making of a decision in relation to an application for a
cannabis research permit. Subsection 9P(4) provides for the grounds in which the
Secretary must refuse to grant a cannabis research permit.
Item 40 inserts a new paragraph 9P(4)(ac) that would require the Secretary to refuse
to grant a permit if the Secretary is satisfied on reasonable grounds that the
application for the permit contains information, or information has been given by the
applicant in relation to the application, that is false or misleading in a material
particular or omits any matter or thing without which the application is misleading in
a material respect.
Item 41 - Subsection 11(4)
This item is a technical amendment and omits the words 'vary or' in subsection 11(4).
Section 11 relates only to the revocation of a cannabis licence or a permit (not to
variation).
Items 42 and 43 - After paragraph 11J(1)(g) and before 12A(4)(b)
Section 11J provides the general circumstances in which the Secretary must refuse to
grant a manufacture licence.
Item 42 inserts a new paragraph 11J(1)(ga) that would require the Secretary to refuse
to grant a licence if the Secretary is satisfied on reasonable grounds that the
application for the licence contains information, or information has been given by the
applicant in relation to the application, that is false or misleading in a material
particular or omits any matter or thing without which the application is misleading in
a material respect.
Section 12A provides for the making of a decision in relation to an application for a
manufacture permit. Subsection 12A(4) provides for the grounds in which the
Secretary must refuse to grant a cannabis research permit.
Item 43 inserts a new paragraph 9P(4)(aa) that would require the Secretary to refuse
to grant a permit if the Secretary is satisfied on reasonable grounds that the
application for the permit contains information, or information has been given by the
applicant in relation to the application, that is false or misleading in a material
particular or omits any matter or thing without which the application is misleading in
a material respect
Item 44 - Subsection 13C(4)
This item is a technical amendment and omits the words 'vary or' under subsection
11(4). Section 11 relates only to the revocation of a manufacture licence or a permit
(and not to variations).
Item 45 - Before section 25
This item inserts a new section 24C to provide that licences under the Narcotic Drugs
Act 1967 are not transferable. This necessary because if any change of ownership of a
24
business were to take place, it would be necessary to consider matters relating to the
fit and proper person test, and other issues in light of a new application from the
prospective business owner.
Item 46 - At the end of subsection 28(1)
Item 46 amends subsection 28(1) by inserting a new paragraph (d) allowing for the
making of regulation in relation to the payment of fees. Regulations made under this
paragraph can prescribe the time and manner of payment of fees, the pro-rating of
fees, provision of refunds, reduction of fees, remission of fees, and the waiving of
applicable fees.
Part 5 - Amendments relating to therapeutic goods
Therapeutic Goods Act 1989
Item 47 - Subsection 19(1A)
Under subsection 19(1) of the Therapeutic Goods Act 1989 the Secretary can approve
the importing and supply of therapeutic goods that have not been approved for general
marketing in Australia for the purposes of use in particular patients (paragraph
19(1)(a)) or for experimental purposes in humans (paragraph 19(1)(b)). The
paragraph 19(1)(a) approvals are known as Special Access Scheme (SAS) - Category
B approvals and the paragraph 19(1)(b) approvals are known as CTX clinical trials.
Item 47 amends subsection 19(1A) of the Therapeutic Goods Act 1989 by replacing
the phrase 'for the purpose mentioned in paragraph (1)(b) is subject to the conditions
(if any specified in the regulations' with the phrase 'mentioned in paragraph (1)(a) or
(b) is subject to the conditions (if any) specified in the regulations for the purposes of
that paragraph'.
This item has the effect of allowing the making of regulations specifying conditions to
apply to SES Category B approvals, as well as conditions to apply to CTX approvals.
Item 48 - Subsection 19(8)
Item 48 repeals subsection 19(8) that was made by the Narcotic Drugs Amendment
Act 2016 and substitutes a new subsection 19(8).
New subsection 19(8) allows for the making of regulations prescribing the
circumstances in which an SAS - Category B approval must not be given by the
Secretary. The circumstances may include, but are not limited to, therapeutic goods
included in a specified class, therapeutic goods when used in the treatment of a
specified class of persons and therapeutic goods when used for a particular indication.
25
SCHEDULE 3 - AMENDMENTS RELATING TO LICENCE CHARGES
Narcotic Drugs Act 1967
Item 1 - Subsection 4(1)
This item inserts a definition of a charge in subsection 4(1). A charge is defined as a
charge imposed under the Narcotic Drugs (Licence Charges) Act 2016.
Item 2 - After paragraph 10P(2)(c)
Section 10P provides for the grounds for the revocation of a cannabis licence or
cannabis permit by the Secretary. Subsection 10P(2) allows the Secretary to revoke a
cannabis licence if satisfied on reasonable grounds that any of the circumstances listed
in this subsection are established.
Item 2 inserts a new ground for revocation (paragraph 10P(2)(ca)), which would apply
if the Secretary is satisfied on reasonable grounds that any charge payable in respect
of the licence is not paid within 28 days after the due date.
Item 3 - After paragraph 13B(2)(c)
Section 13B provides for the grounds for the revocation of a manufacture licence or
manufacture permit by the Secretary. Subsection 13B(2) allows the Secretary to
revoke the manufacture licence if satisfied on reasonable grounds that any of the
circumstances listed in this subsection are established.
Item 3 inserts a new ground for revocation (paragraph 13B(2)(ca)), which would
apply if the Secretary is satisfied on reasonable grounds that any charge payable in
respect of the licence is not paid within 28 days after the due date.
Item 4 - At the end of subsection 28(1)
Item 4 amends subsection 28(1) by inserting a new paragraph (e) allowing for the
making of regulations in relation to the payment of charges. Regulations made under
this paragraph can prescribe the time and manner of payment of fees, the pro-rating of
fees, provision of refunds, reduction of fees, remission of fees and the waiving of
applicable charges.
26