Clause by clause analysis
Clause 1 is the Title clause.
Clause 2 is the commencement clause. It provides that the Bill comes into force on the day after the date on which it receives the Royal assent.
Clause 3 provides that the Bill amends the Psychoactive Substances Act 2013 (the principal Act).
Clause 4 amends section 4, which sets out principles that are to be taken into account in the performance of functions or duties or the exercise of powers under the principal Act. Clause 4 adds, as a principle, that animals must not be used in trials for the purposes of assessing whether a psychoactive product should be approved.
Clause 5 amends section 6, which sets out an overview of the principal Act, by repealing the subparagraph that refers to the sale of psychoactive products on an interim basis.
Clause 6 replaces section 12, which currently restricts the type of trials involving animals to which the Psychoactive Substances Expert Advisory Committee (the advisory committee) may have regard in evaluating psychoactive products and giving advice on the products to the Psychoactive Substances Regulatory Authority (the Authority).
New section 12(1) provides that the advisory committee must not have regard to the results of any trial that involves the use of an animal.
New section 12(2) provides that the advisory committee may have regard to the results of a trial undertaken overseas if the committee considers that the trial shows that a psychoactive product would pose more than a low risk of harm to individuals using the product. This is to ensure that, if information from trials undertaken overseas involving animals is available and the information shows a product would pose more than a low risk of harm to individuals, the advisory committee can use that information to protect the health of individuals by recommending that a product not be approved.
Section 33(3) of the principal Act provides that applications for approval of psychoactive products must not include particulars, information, documents, or other material that the advisory committee must not have regard to under new section 12.
The effect of section 33(3), after the commencement of new section 12, is that the results of any trial involving animals must not form part of the information provided to the Authority in support of an application for approval of a psychoactive product. The exception is information from a trial undertaken overseas where the trial shows that a product poses more than a low risk of harm to individuals.
Clause 7 amends section 37 of the principal Act to impose a similar restriction on the information that the Authority may have regard to in deciding whether to approve a product. New subsection (3) provides that the Authority must not, in deciding whether to approve a product, have regard to any particulars, information, documents, or other material that the advisory committee must not have regard to under new section 12.
The effect of new section 37(3) is that the Authority must not have regard to the results of any trial involving animals when deciding whether or not to approve a psychoactive product. The exception is information from a trial undertaken overseas where the trial shows that a product poses more than a low risk of harm to individuals.
In summary, the principal Act, once amended, will effectively provide that a trial involving animals cannot be used to support an application for approval of a psychoactive product. If a person intended to carry out such a trial in New Zealand regardless, it is expected that the trial would require approval under the Animal Welfare Act 1999. In the absence of such approval, carrying out the trial would be in breach of that Act and the penalties provided in that Act would apply.
Clause 7 also amends section 37 to provide, for the avoidance of doubt, that if the Authority is unable to satisfy itself that a psychoactive product poses no more than a low risk of harm, the Authority must refuse to approve the product.
Clause 8 provides that Schedule 1 of the principal Act, which deals with interim approval of products and the issue of interim licences, is amended as set out in the Schedule of the Bill. The amendments to Schedule 1 are as follows:
some references to interim approvals of psychoactive products, and to such products approved on an interim basis, are removed:
clauses 3 to 6, which provided for applications for and grants and duration of interim approvals, are repealed:
clause 8 is amended to clarify that the provisions of subparts 1 and 3 of Part 2 of the principal Act apply to interim licences granted under Schedule 1:
new clause 11 revokes every interim approval of a psychoactive product:
new clause 12 provides that the Authority must, before the close of the day after the date of the commencement of that clause, issue a recall order under section 88 in respect of the products:
new clause 13 revokes every interim licence to sell psychoactive products with interim approval:
new clause 14 confirms that interim licences to sell psychoactive products granted interim approval (by retail or wholesale) and interim approvals of products may not be granted, regardless of the outcome of any extant appeal under subpart 3 of Part 2:
new clause 15 preserves, until the close of the 14th day after the date of the commencement of the Bill and for the purpose of the recall under clause 12, the powers of entry and search under section 78 in relation to the holders of interim licences for the sale of psychoactive products with interim approval (despite the revocation of those interim licences under clause 13):
new clauses 16 and 17 impose a moratorium on the Authority processing—
applications for licences under section 13 until regulations relating to licence applications come into force:
applications for approvals of psychoactive products under section 33 until regulations relating to applications for product approval come into force:
new clause 18 provides that no compensation or damages are payable by the Crown for any loss or damage arising from the enactment of the Bill.