Misuse of Drugs (Medicinal Cannabis) Amendment Bill

2.1. Are there any publicly available inquiry, review or evaluation reports that have informed, or are relevant to, the policy to be given effect by this Bill?

YES

The Expert Advisory Committee on Drugs’ advice to the then Associate Minister of Health on the classification of CBD, dated 14 February 2017, is available on the Ministry of Health’s website.

http://www.health.govt.nz/new-zealand-health-system/key-health-sector-organisations-and-people/ministerial-health-committees/national-drug-policy-committees#eacd26oct

2.2. Does this Bill seek to give effect to New Zealand action in relation to an international treaty?

NO

2.3. Were any regulatory impact statements provided to inform the policy decisions that led to this Bill?

YES

Impact Statement: Medicinal Cannabis 100-day Action, Ministry of Health, 14 December 2018

The RIS will be available on the Treasury website at:

http://www.treasury.govt.nz/publications/informationreleases/ris

and on the Ministry of Health website at:

http://www.health.govt.nz/about-ministry/legislation-and-regulation/regulatory-impact-statements

2.3.1. If so, did the RIA Team in the Treasury provide an independent opinion on the quality of any of these regulatory impact statements?

YES

The Regulatory Quality Team at the Treasury has reviewed the Regulatory Impact Statement “Medicinal Cannabis:  100 day action” by the Ministry of Health in accordance with arrangements for 100-day plan priorities.

The Regulatory Impact Statement sets out the current position as regards the use of cannabis for medicinal purposes and how the proposed legislation is intended to provide comfort for a specific class of users by providing an exception and statutory defence for terminally ill people.

As noted in the section “Key Limitations or Constraints on Analysis”, there is a lack of information about current patterns of usage and demand, including demand that is currently suppressed by legal restrictions, which limits assessment of the likely impacts of lifting those legal restrictions.

The RIS does not analyse the nature and scope of the proposal for a medicinal cannabis scheme.  This raises the risk that it may be necessary to reconsider these questions in the course of the detailed design of that scheme, which is to be considered later. It will also be important to monitor and take into account any evidence of changes in demand and supply patterns following the introduction of the exception and statutory defence, in the development and eventual management of the proposed medicinal cannabis scheme.

2.3.2. Are there aspects of the policy to be given effect by this Bill that were not addressed by, or that now vary materially from, the policy options analysed in these regulatory impact statements?

YES

A further Impact Assessment for the detail of a medicinal cannabis scheme, expected to include the establishment of a government agency for domestic production of medicinal cannabis and enabling standards to be set, will be provided when further detail has been developed. An initial report is to be provided in March 2018. This paper deals with the inclusion of regulation making powers included in the Bill.

The impact of the proposal to deschedule CBD is expected to be minor in practice. The amendment removes requirements and does not create any new ones.

2.4. Has further impact analysis become available for any aspects of the policy to be given effect by this Bill?

NO

2.5. For the policy to be given effect by this Bill, is there analysis available on:

(a)   the size of the potential costs and benefits?

NO

(b)   the potential for any group of persons to suffer a substantial unavoidable loss of income or wealth?

NO

The proposed changes to the Misuse of Drugs Act 1975 will benefit the terminally ill, who use, or intend to use, illicit cannabis products. Introduction of an exception and statutory defence will provide a level of comfort and reassurance to the terminally ill that they may possess and use illicit cannabis without fear of prosecution.

The regulation making power to enable a medicinal cannabis scheme that enables access to products made to a quality standard in a timely way will benefit medical practitioners and their patients who wish to have access to cannabis products. Costs and benefits of the medicinal cannabis scheme will be addressed in the planned March paper when further detail of the proposed scheme is developed.

There may be resource requirements for NZ Police, as investigating whether there is a valid defence will use operational time. There may be some impact on Court resources if a terminally ill person defends a charge.

There may be a small cost to terminally ill people who wish to access illicit cannabis in obtaining a medical certificate or letter to prove they are terminally ill.

None of the provisions in the Bill would cause business or individuals to suffer a substantial or unavoidable loss of income or wealth.

2.6. For the policy to be given effect by this Bill, are the potential costs or benefits likely to be impacted by:

(a)   the level of effective compliance or non-compliance with applicable obligations or standards?

NO

(b)   the nature and level of regulator effort put into encouraging or securing compliance?

NO

The Bill extends an exception and a statutory defence for terminally ill to possess and use illicit cannabis, creates a mechanism to set quality standards for products by regulation and deschedules CBD. As such the issue of compliance does not arise.

3.1. What steps have been taken to determine whether the policy to be given effect by this Bill is consistent with New Zealand’s international obligations?

The exception and statutory defence provisions are consistent with New Zealand’s obligations under the United Nations’ Drug Conventions.

3.2. What steps have been taken to determine whether the policy to be given effect by this Bill is consistent with the principles of the Treaty of Waitangi?

No issues were identified in the development of the policies that may have specific implications for the rights and interests of Māori protected by the Treaty of Waitangi.  As such, no formal steps have been taken to determine whether the policies to be given effect by this Bill are consistent with the principles of the Treaty of Waitangi.

3.3. Has advice been provided to the Attorney-General on whether any provisions of this Bill appear to limit any of the rights and freedoms affirmed in the New Zealand Bill of Rights Act 1990?

YES

Advice provided to the Attorney-General by the Ministry of Justice is generally expected to be available on the Ministry of Justice's website upon introduction of a Bill.  Such advice will be accessible on the Ministry's website at http://www.justice.govt.nz/policy/constitutional-law-and-human-rights/human-rights/bill-of-rights/

3.4. Does this Bill create, amend, or remove:

(a)   offences or penalties (including infringement offences or penalties and civil pecuniary penalty regimes)?

YES

(b)   the jurisdiction of a court or tribunal (including rights to judicial review or rights of appeal)?

NO

The exception and statutory defence for terminally ill people to possess and use illicit cannabis amends section 7 of the Misuse of Drugs Act.

3.4.1. Was the Ministry of Justice consulted about these provisions?

YES

The Ministry of Justice was consulted on the policy as part of the Cabinet Business Committee paper and on the Amendment Bill.

3.5. Does this Bill create, amend or remove any provisions relating to the collection, storage, access to, correction of, use or disclosure of personal information?

NO

3.5.1. Was the Privacy Commissioner consulted about these provisions?

NO

3.6. Has there been any external consultation on the policy to be given effect by this Bill, or on a draft of this Bill?

NO

While there was no specific consultation on the policy that is given effect in this Bill, improving access to medicinal cannabis was part of the new Government’s manifesto commitments.

3.7. Have the policy details to be given effect by this Bill been otherwise tested or assessed in any way to ensure the Bill’s provisions are workable and complete? 

YES

Police have been consulted to ensure the proposals are workable from an enforcement perspective. The Ministry will continue to work with Police, as well as other agencies and health practitioners to develop guidelines for terminally ill people, medical practitioners, nurse practitioners and enforcement agencies.

4.1. Does this Bill contain any provisions that could result in the compulsory acquisition of private property?

NO

4.2. Does this Bill create or amend a power to impose a fee, levy or charge in the nature of a tax?

NO

4.3. Does this Bill affect rights, freedoms, or impose obligations, retrospectively?

NO

4.4. Does this Bill:

(a)   create or amend a strict or absolute liability offence?

NO

(b)   reverse or modify the usual burden of proof for an offence or a civil pecuniary penalty proceeding?

YES

The exception means that a person, who has certification from a medical practitioner or nurse practitioner that they are terminally ill, will not commit an offence if they possess or use illicit cannabis. The statutory defence is a defence against prosecution where a person is unable to produce immediate evidence of a terminal illness at the time of questioning by Police, but is able to produce evidence in court.

The onus is on the terminally ill person to provide evidence that the exception or statutory defence applies.

4.5. Does this Bill create or amend a civil or criminal immunity for any person?

YES

Section 5 of the Bill creates a criminal immunity for terminally ill people who possess and use illicit cannabis.

4.6. Does this Bill create or amend a decision-making power to make a determination about a person’s rights, obligations, or interests protected or recognised by law, and that could have a significant impact on those rights, obligations, or interests?

NO

4.7. Does this Bill create or amend a power to make delegated legislation that could amend an Act, define the meaning of a term in an Act, or grant an exemption from an Act or delegated legislation?

No

4.8. Does this Bill create or amend any other powers to make delegated legislation?

YES

Section 6 of the Bill creates a regulation-making power to enable the setting of standards that products manufactured, imported, and supplied under licence must meet.

This will allow the setting of minimum quality standards for both domestically produced and imported cannabis products.

Very few cannabis products have been assessed by a therapeutic regulator such as Medsafe or the Food & Drugs Administration.

The ability to set and require minimum quality standards for cannabis products will improve patient safety and give medical practitioners confidence about the products available under a Medicinal Cannabis Scheme.

4.9. Does this Bill contain any provisions (other than those noted above) that are unusual or call for special comment?

NO