Gene Technology 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

Interim Regulatory Impact Statement: Improving our GMO regulations for laboratory and biomedical research. Ministry for the Environment. 2023.

https://environment.govt.nz/what-government-is-doing/cabinet-papers-and-regulatory-impact-statements/improving-our-gmo-regulations-for-laboratory-and-biomedical-research/

The Third Review of the National Gene Technology Scheme. Commonwealth of Australia as represented by the Department of Health. 2018.

https://www.genetechnology.gov.au/reviews-and-consultations/past/2017-third-review

Ko Aotearoa Tēnei: A Report into Claims concerning New Zealand Law and Policy Affecting Māori Culture and Identity, Taumata Tuatahi; and Ko Aotearoa Tēnei: A Report into Claims concerning New Zealand Law and Policy Affecting Māori Culture and Identity, Taumata Tuarua (Volumes 1 and 2). Waitangi Tribunal. 2011.

All reports are available at https://www.waitangitribunal.govt.nz/en/publications/tribunal-reports

Gene editing: Legal and regulatory implications; Gene editing in healthcare; Gene editing for pest control; and Gene editing for the primary industries. Royal Society Te Apārangi. 2019.

All reports are available at https://www.royalsociety.org.nz/major-issues-and-projects/gene-editing-in-aotearoa/

Further reports can be found at Appendix One.

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

NO

However, the Bill is consistent with New Zealand’s international obligations – refer to question 3.1 response.

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

YES

MBIE completed Regulatory Impact Statement – Reform of Gene Technology Regulation in July 2024 to inform the policy decisions of Cabinet in August 2024 on the Bill. It can be accessed at:

https://www.mbie.govt.nz/science-and-technology/science-and-innovation/agencies-policies-and-budget-initiatives/gene-technology-regulation

https://www.regulation.govt.nz/mfr-what-we-do/regulatory-impact-analysis-ria/regulatory-impact-statements-riss

Some information in the Regulatory Impact Statement is withheld, on the grounds of confidential advice to Government; damage to New Zealand’s economic interests; free and frank opinions; national security; and legal professional privilege.

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?

NO

The RIS identified above did not meet the threshold for receiving an independent opinion on the quality of the RIS from the RIA Team based in the Treasury.

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

Aspects of policy to be given effect by the Bill that were not addressed by the policy options analysed in the RIS

Given time constraints and the stage of policy development when the RIS was completed, the RIS did not cover the following policy matters that are to be given effect by the Bill:

·         statutory determinations

·         suspension, cancellation, surrender, variation, and transfer of licences

·         reassessments, and reviews and appeals

·         inspection, enforcement and ancillary powers

·         offences, defences and penalties

·         civil liability

·         information sharing

·         interaction with the Official Information Act 1982

·         various administrative matters including the Gene Technology Regulator’s register.

Policy settings for these matters have since either been agreed by the Minister responsible for the Bill under delegated authority from Cabinet following consultation with relevant Ministers or are being proposed to Cabinet when it considers the Bill for introduction.

Aspects of policy to be given effect by the Bill that now vary materially from the policy options analysed in the RIS

The Bill will establish mechanisms to enable the Gene Technology Regulator to consider material adverse effects on Māori kaitiaki relationships with indigenous species that may result from risks to the environment from a regulated organism.

This option, which differentiates between Māori kaitiaki relationships with indigenous species and non-indigenous species, was not analysed in the RIS. The RIS analysed options in relation to kaitiaki relationships with both indigenous species and non-indigenous species of significance (a list of 10 species in schedule 2 of the Plant Variety Rights Regulations 2022).

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?

YES

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

YES

The Regulatory Impact Statement sets out the most up-to-date information used by MBIE in relation to potential costs and benefits, and likely affected parties. Refer to the Executive Summary section, and Section 2 on the marginal costs and benefits.

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?

YES

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

YES

Expected benefits of the regime established by the Bill include a reduced compliance burden for regulated parties seeking to develop and use gene technologies. Further information and analysis is contained in the Regulatory Impact Statement (summarised in the Executive Summary).

Regulator effort will be necessary to secure compliance by regulated parties with conditions associated with authorisations and applicable standards. The Gene Technology Regulator and the Ministry for Primary Industries (MPI) will both have roles in providing information and education to regulated parties about how to comply; MPI will also be resourced to implement an effective strategy to secure compliance.

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?

MBIE has consulted the Ministry of Foreign Affairs and Trade and other relevant agencies to identify how the policy to be given effect by this Bill needs to be consistent with New Zealand’s international obligations under the Convention on Biological Diversity (CBD) and the Cartagena Protocol on Biosafety. Of most relevance are New Zealand’s obligations as a party to the Cartagena Protocol (accessible at https://bch.cbd.int/protocol/text).

To ensure the Bill is consistent with these obligations, subject to Cabinet agreement, it will require the Gene Technology Regulator to have regard to New Zealand’s international obligations under the CBD and the Cartagena Protocol in its decision making.

MBIE has also consulted with the Ministry of Health to identify how the policy to be given effect by the Bill needs to be consistent with New Zealand’s obligations relating to protecting the confidentiality of information related to certain medicines applications under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement, accessible at https://www.wto.org/english/docs_e/legal_e/27-trips_01_e.htm) and the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (refer Article 18.50, accessible at https://www.mfat.govt.nz/assets/Trade-agreements/TPP/Text-ENGLISH/18.-Intellectual-Property-Chapter.pdf).

To ensure the Bill is consistent with these obligations, subject to Cabinet agreement, it will mirror specific confidentiality provisions from the Medicines Act 1981 and the Agricultural Compounds and Veterinary Medicines Act 1997 in respect of applications the Gene Technology Regulator may receive for approval of a gene technology or regulated organism that is (or is part of) a medicine.

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?

MBIE conducted targeted engagement with Māori to inform policy development for the Bill. This involved:

·         establishing a Māori Focus Group to provide advice and guidance to officials on policy including matters to be considered to safeguard the interests of Māori; processes a regulator should implement to ensure Māori interests are identified, understood, and considered in the decision-making process; and identifying and understanding Māori rights and interests for the development of advice;

·         interviews with individual leaders of iwi across the country, including the Iwi Chairs Science Committee; and

·         a hui with Māori from the research and innovation sectors.

This engagement, alongside advice from other government agencies, helped inform provisions in the Bill:

·         requiring the Gene Technology Regulator to consider potential adverse effects on Māori kaitiaki relationships with indigenous species before making certain decisions;

·         establishing a dedicated advisory mechanism for the Regulator in the form of a Māori Advisory Committee; and

·         requiring the Regulator to have regard to that advice before making a decision.

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, or a section 7 report of the Attorney-General, is expected to be available on the Ministry of Justice’s website upon introduction of the Bill (accessible from https://www.justice.govt.nz/justice-sector-policy/constitutional-issues-and-human-rights/the-bill-of-rights-act/compliance-reports/)

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)?

YES

Part 3 of the Bill creates offences and penalties and civil pecuniary penalties that will apply under the Gene Technology Act. Subpart 3 sets out offences; Subpart 4 sets out infringement offences; and Subpart 5 sets out pecuniary penalties.

Part 5,  Subpart 2 of the Bill creates rights of appeal. Judicial review is not limited in any way.

Subject to Cabinet agreement, the Bill will not include statutory civil liability provisions, which is a departure from the status quo. HSNO includes a strict liability provision for civil liability, whereby a person is liable for damages for any loss or damage caused while carrying out activities in breach of the Act, regardless of whether they intended to do the thing that resulted in the breach or took reasonable care.

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

YES

MBIE engaged with the Ministry of Justice throughout development of the offences and penalties regime for the Gene Technology Act to seek both general and specific advice on the appropriate penalty settings and to ensure the offences and penalties achieved the policy intent. This included consultation on briefing materials seeking ministerial decisions. MBIE received feedback from MoJ to improve the construction of the regime both generally and specifically and incorporated these changes into final policy.

The Ministry of Justice was informed of the detailed design of the appeals regime, which is comparable to the current appeals regime for genetically modified organisms under HSNO.

The Ministry of Justice was informed about the proposal not to include statutory civil liability in the Gene Technology Act.

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?

YES

The Bill creates a licensing regime for gene technologies and regulated organisms (Part 2, Subpart 3), and sets out what information, including personal information, will be required in applications for a licence. Some application information requirements will be set by regulations. Certain activities under the Bill will not require a licence, but a person carrying out the activity must notify the Gene Technology Regulator they are carrying out the activity.

To make licensing decisions, the Regulator will assess an application, and for higher risk or uncertain activities this may include public consultation. The Bill includes a provision that the Regulator may withhold personal information for purposes under the Act, such as publicly notifying a consultation on an application for a licence, or publishing information on the Register (refer Part 2, Subpart 8).

The Bill also enables the Regulator to undertake joint assessments of licence applications with recognised overseas gene technology regulators, the intent of which is to gain efficiencies in the decision-making process. For such an assessment to take place, the Bill first requires an agreement to be in place with the relevant overseas regulator, and for the Privacy Commissioner to have been consulted on that agreement (refer Part 5, Subpart 4).

Part 5, Subpart 4 of the Bill sets out information sharing provisions that enable disclosure of information (including personal information) under certain Acts to support the effective operation of the gene technology regime. For example:

·         the Regulator may obtain information collected under another Act to be satisfied that the applicant is a fit and proper person to hold a licence (refer Part 2, Subpart 3); and

·         the enforcement agency (the Ministry for Primary Industries) may notify the Regulator of a breach of conditions attached to an authorised activity.

Part 5, Subpart 4 enables agencies to impose conditions relating to the disclosure of information.

These provisions will override the Information Privacy Principles contained in the Privacy Act 2020, particularly principles 2, 11, and 12.

Part 2, subpart 8 of the Bill also requires the Regulator to maintain a public register which will include details about licences, authorisations, activities, determinations, recognised overseas authorities, and persons approved under the synthetic nucleic acid screening regime.

3.5.1. Was the Privacy Commissioner consulted about these provisions?

YES

MBIE has initiated engagement with the Office of the Privacy Commissioner (OPC) about the proposed information sharing provisions. OPC indicated it is concerned that the need for the Bill to override the Information Privacy Principles has not yet been justified. MBIE officials will work with the Office of the Privacy Commissioner to identify any necessary safeguards that are required to ensure the protection and proper use of personal information under the Bill.

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?

YES

MBIE conducted targeted engagement and convened a Technical Advisory Group, Industry Focus Group and Māori Focus Group to advise MBIE on the policy proposals. For further detail refer to Annex B of the Regulatory Impact Statement (links provided in the response to question 2.3).

In the course of refining policy for the Bill, MBIE has:

·         continued to seek advice from the Technical Advisory Group

·         had regular engagement with the Environmental Protection Authority, and

·         engaged on specific policy elements with the Office of the Ombudsman and the Office of the Privacy Commissioner.

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?

NO

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?

YES

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

NO

The Bill creates strict liability offences (refer Part 3, Subpart 3) if a person:

·         carries out an activity in relation to a regulated organism, without authorisation

·         breaches a condition attached to a licence

·         breaches a condition attached to a notifiable or non-notifiable activity

·         fails to comply with a requirement, direction or compliance order

·         gives information that is false or misleading when required to provide information under the Act, or

·         fails to comply with the synthetic nucleic acid screening regime.

Under the new regime, there is likely to be a greater prevalence of genetically modified organisms in New Zealand. These offences are considered appropriate as they create an incentive for people carrying out regulated activities to adopt appropriate precautions, given that breaches could result in severe damages to New Zealand’s environment and the health and safety of people. The Bill provides that the person has a defence against a strict liability offence if they can prove that the circumstances were outside their control, or their actions were necessary for certain purposes or were reasonable in the circumstances.

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

YES

The Bill provides protection from civil and criminal liability for the Gene Technology Regulator, an employee or agent of the Regulator, an enforcement officer, a member of the Technical Advisory Committee or Māori Advisory Committee, and a member of any subcommittee of those committees. Refer to Part 5, Subpart 8, clause 187.

This is in line with protections afforded to officials when carrying out their functions and duties and exercising their powers in good faith.

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?

YES

Part 5, Subpart 5, clause 155(1)(a) creates a power to make regulations for the matters prescribed in clause 163 “Power to make further exemptions from operation of Act and nonregulated activities”. This clause provides for delegated legislation to be made that will exempt organisms or categories of organisms and gene-editing techniques from being regulated under the Act.

Part 5 Subpart 5, clause 155(1)(d) creates a power to make regulations prescribing circumstances in which the Regulator may waive any fee or levy under this Act.

Part 2, Subpart 1 enables specific terms to be amended by regulations, for example including or excluding things from the definition of regulated organism, gene technology and conventional processes.

Additional detail in response to this question is included in Appendix Two.

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

YES

Part 2, Subpart 3 clause 23, and subpart 4 clauses 47 and 48 provide that the Gene Technology Regulator has the power to declare by notice in the Gazette that an activity in relation to a regulated organism is a pre-assessed, non-notifiable or a notifiable activity.

Part 5, Subpart 3 provides for the Regulator to make delegated legislation in the form of issuing or approving standards for minimising the risks to health and safety of people and the environment.

Part 5, Subpart 5 provides for specific regulation making provisions, general provisions for secondary legislation and the process for making regulations. The regulation making powers cover a wide range of matters including joint applications, setting criteria for placing an activity under a risk tier, exemptions from the operation of the Act and offences. A detailed list of the regulations provisions can be found in Appendix Two.

Additional detail in response to this question is included in Appendix Two.

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

YES

Appointment and accountability of the Gene Technology Regulator

The Bill provides for the minister responsible for the Gene Technology Act (the Minister) to appoint the Gene Technology Regulator, who will be an employee of the Environmental Protection Authority (EPA). This is a unique arrangement, as ministers do not normally appoint staff of Crown entities. The principle embodied in the Public Service Act 2020 and the Crown Entities Act 2004 is that those with legal accountability for an organisation’s work appoint its staff. The Gene Technology Regulator will be a statutory officer, employed by but not accountable to the EPA board in relation to their statutory functions. The Bill provides that the Regulator will be accountable to the responsible minister but does not specify the arrangements for reporting on its activities and use of appropriations.

Limitation on the application of the Official Information Act 1982

The Bill includes a limitation on the application of the Official Information Act 1982 (OIA). It will not apply to information received by the Gene Technology Regulator that is likely to relate to a licence application that has not yet been made. The OIA will apply once the application is received by the Regulator. This limitation is necessary to protect confidential information while an application is being developed and to avoid discouraging pre-application engagement with the Regulator.

Amendments to the Resource Management Act 1991

The Bill will amend the Resource Management Act 1991 (the RMA) to remove the ability for regional councils and territorial and unitary authorities to restrict the use of genetically modified organisms (GMOs).

It will also amend the RMA to address operative plan rules, and consents and consent applications relating to activities with GMOs at the time the Gene Technology Act commences.

Any operative plan rules about activities with GMOs will cease to have effect immediately, so that the transition to a nationally consistent regime for regulating GMOs can occur as quickly as possible. Consent holders and applicants (if any) may choose to continue with the consent or application if that suits their circumstances or choose to surrender or withdraw it.