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Narcotic Drugs Legislation Amendment Bill 2016

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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 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 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.

 

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.

 

 

 



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 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.

 

 

 

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



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. 



 

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).

 

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). 

 

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 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.

 

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, 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.

 

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.



 

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 10 K

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

 

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).

 

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 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 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.

 

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.

 

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 ). 

 

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 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 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.



 

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.