Explanatory note
This Supplementary Order Paper (SOP) makes various amendments to the Psychoactive Substances Bill. The majority of these changes are minor and technical and are made to ensure consistency among provisions, to fix cross-reference errors, and to make general drafting refinements or improvements. The SOP also makes substantive changes to clause 11A (which relates to the duty of the advisory committee relating to the use of animals when evaluating psychoactive products), clause 31 (which relates to applications for approval of a psychoactive product), and Schedule 1 (which relates to the transitional arrangement for psychoactive products lawfully sold before commencement of the Bill), and several other provisions. The effect of the substantive changes is as follows:
Clauses 11A and 31(3)
The purpose of clause 11A is to minimise the use of animals in trials relating to psychoactive products where suitable alternatives exist. This SOP recasts clause 11A and adds new clause 31(3) to give better effect to that purpose.
Clause 11A(1) provides that the advisory committee, when performing the function set out in clause 11(2)(a) (which is to evaluate, with regard to the results of trials, psychoactive products to assess whether they should be approved for use by individuals), must comply with clause 11A(2) and (3).
Clause 11A(2) provides that if a suitable alternative trial that does not involve the use of an animal has been publicly notified by the Authority, the advisory committee must not have regard to the results of a trial that involves the use of an animal.
Clause 11A(3) provides that if a suitable alternative trial does not exist, the advisory committee may only have regard to the results of a trial that involves the use of an animal if—
the trial is based on the relevant International Conference on Harmonisation Guidelines; and
the trial complies with—
the restrictions set out in Part 6 of the Animal Welfare Act 1999 (the AWA) or, if undertaken overseas, complies with restrictions that are equivalent to, or exceed, those set out in the AWA; and
any guidelines issued by the Authority relating to the use of animals in trials; and
use of the trial is periodically reviewed to ensure there is up-to-date analysis of available alternatives to reduce the number of animals used and to reduce harm to animals that are used in trials.
Clause 11A(4) defines a suitable alternative as a trial that does not involve the use of an animal and that is publicly notified by the Authority, on the recommendation of the advisory committee, as a suitable alternative.
Clause 11A(5) requires the advisory committee, in considering whether to recommend a suitable alternative, to have particular regard to—
the principle in clause 4(a) (which provides that a psychoactive product that is approved for use by individuals should pose no more than a low risk of harm to individuals who use it); and
the likelihood of psychoactive products being used by young adults.
New clause 31(3) provides that an application for approval of a psychoactive product must not include particulars, information, documents, or other material that the advisory committee must not have regard to under clause 11A. The effect of this change is that the results of any trial using animals for which a suitable alternative exists and that has been publicly notified by the Authority must not form part of the information provided to the Authority in support of an application for approval of a psychoactive product.
Schedule 1
This SOP replaces Schedule 1, which contains a transitional provision relating to psychoactive products that were being lawfully sold throughout the period of 3 months immediately before the commencement of the Bill, with a new Schedule 1. The new Schedule 1 provides that the Authority may grant interim approval of psychoactive products and interim licences during the period after commencement of the Bill and until regulations made under clause 79F (which relates to fees and charges) and clause 83(1)(a) (which relates to information that must accompany applications for approval and licences) come into force.
Clause 1 defines certain terms used in new Schedule 1.
Clause 2 provides that new Schedule 1 applies to psychoactive substances and psychoactive products that were lawfully being imported, manufactured, researched, or sold in the period of 3 months immediately before the commencement of the Bill.
Interim approval of psychoactive products
Clauses 3 to 6 relate to the grant of an interim approval of a psychoactive product by the Authority. Clause 3 provides that a person who is a New Zealand resident may, within 28 days after the commencement of the Bill, apply for the interim approval of a psychoactive product to which Schedule 1 applies. Clause 3(2) and (3) requires that the application must be accompanied by, among other things,—
a statutory declaration made by the applicant stating that the psychoactive product to which the application relates was being lawfully sold in New Zealand throughout the period of 3 months immediately before the commencement of the Bill; and
the fee payable for the interim approval, which is $10,000 (see clause 10).
Clause 4 relates to the grant of an interim approval. It provides that subparts 2 and 3 of Part 2 of the Bill (which relates to applications for approval and appeals against decisions of the Authority) apply, with any necessary modifications, to an application for interim approval of a psychoactive product as if it were an application for an approved product.
Clause 5 applies the provisions of Part 3 of the Bill, with any necessary modifications, as if the psychoactive product that was granted interim approval were an approved product. Accordingly, the following provisions (among others) will apply to a psychoactive product granted interim approval:
clauses 46 to 60 of the Bill (which impose age restrictions on the sale and supply of psychoactive products and impose place-of-sale, advertising, labelling, and free-of-charge distribution restrictions and requirements on those products):
clauses 61 to 61D of the Bill (which enable a local authority to adopt a local approved products policy):
clause 78 of the Bill (which enables the Authority to recall a psychoactive product that was granted interim approval during the period that the interim approval is in force):
clause 80 of the Bill (which relates to the duty of specified persons to notify the Authority about adverse reactions).
Clause 6 relates to the duration of an interim approval. It provides that, within 28 days after the date on which regulations made under clauses 79F and 83(1)(a) of the Bill come into force, the person who applied for interim approval of a psychoactive product must decide whether to make a full application to the Authority in respect of the product under clause 31 of the Bill and must notify the Authority accordingly.
Clause 6(3) and (4) provide that, where the person who applied for the interim approval notifies the Authority that the person does not wish to proceed with a full application in respect of the psychoactive product, the interim approval of the product is deemed to be revoked on the date on which the Authority receives that notification.
Clause 6(5) provides that, where the person who applied for the interim approval notifies the Authority that the person does wish to proceed with a full application, the interim approval granted in respect of the psychoactive product continues in force until the date on which the full application is determined under the Bill and is then deemed to be revoked.
Clause 6(6) enables the Authority to require a person who has notified the Authority that he or she wishes to make a full application in respect of a psychoactive product that was granted interim approval to provide the Authority with any relevant information in order to establish whether that person is taking reasonable steps to submit a full application.
Clause 6(7) enables the Authority to revoke an interim approval where, after considering any information provided under clause 6(6), the Authority is not satisfied that the person is taking reasonable steps to make a full application in respect of the product.
Interim licences to sell psychoactive products
Clauses 7 to 9 enable the Authority to issue an interim licence to a person who, in the period of not less than 28 days immediately before the commencement of the Bill, was in the business of lawfully importing, manufacturing, researching, or selling psychoactive substances or psychoactive products.
Clause 7 provides that a person who is a New Zealand resident may, within 28 days after the commencement of the Bill, apply to the Authority for 1 or more interim licences. Clause 7(2) and (3) require that the application for an interim licence must be accompanied by, among other things,—
a statutory declaration made by the applicant stating that the applicant was, during the period of not less than 28 days before commencement of the Bill, in the business of importing, manufacturing, researching, or selling psychoactive substances or psychoactive products to which Schedule 1 applies and that the applicant is aware of any conditions or other requirements pertaining to the licence and agrees to comply with them; and
the appropriate fee payable for the interim licence, which is $500 in the case of each interim licence (see clause 10).
Clause 8 relates to the grant of an interim licence. It provides that subparts 1 and 3 of Part 2 of the Bill (which relates to applications for licences and appeals against decisions of the Authority) apply, with any necessary modifications, to an application for an interim licence as if it were an application for a licence made under clause 12 of the Bill.
Clause 9 relates to the duration of an interim licence. It provides that an interim licence is deemed to be cancelled 28 days after the date on which regulations made under clauses 79F and 83(1)(a) of the Bill come into force, unless the holder of the interim licence makes a full application in respect of the activity to which the interim licence relates. If the holder of the interim licence makes a full application, the interim licence continues in force until the date on which that application is determined under the Bill and is then deemed to be cancelled.
Fees for interim approval and interim licences
Clause 10 specifies the fees (inclusive of goods and services tax) payable to the Authority for an application for an interim approval or an application for an interim licence.
Other changes
Clause 8, which contains definitions, is amended to clarify some existing definitions and to insert new definitions of trial and publicly notify to reflect changes to clause 11A.
Clause 11(2A) is amended to clarify that the list of matters specified in that subclause relates to matters the advisory committee must have regard to in evaluating psychoactive products.
New clause 15(3)(ab) is inserted to include offences against the Medicines Act 1981 in the list of relevant offences that the Authority must take into account in determining whether the applicant is a fit and proper person to hold the licence or is a body corporate of good repute.
Clause 16(3) is recast to provide that it is a compulsory condition of a licence to sell psychoactive substances that the holder of the licence may only sell psychoactive substances that are not approved products to a person in New Zealand who holds—
Clause 26, which provides that it is an offence to breach any conditions of a licence, is amended to simplify the drafting of the provision. The penalties remain the same.
Clause 35 is amended to align the provision more closely with new clause 4(ba), which provides that a psychoactive product that poses no more than a low risk of harm to individuals who use the product should be approved, by providing that the Authority must approve an application for approval where the application meets all the requirements for approval.
Clause 48 provides that it is an offence to supply of an approved product in a public place to a person who is aged under 18 years. However, a defendant has a defence if he or she proves that he or she had reasonable grounds to believe that the person to whom the product was supplied was 18 years or over. Clause 48(4) specifies the circumstances in which reasonable grounds will exist for the purposes of that defence. Clause 48(4) has been amended to remove the reference to an approved evidence of age system because the use of such a system is unlikely in the context of the social supply of approved products.
Clause 61C is amended to clarify that a local approved products policy adopted by a local authority under the Bill may regulate the density of approved product retail outlets.
Clause 72(3), which provides that a constable may arrest a person who has persistently refused or failed to provide particulars when required under clause 72, is deleted because the power to arrest in these circumstances is covered by clause 74.