Report on the Regulatory Framework Governing Assisted Reproductive Technologies in New Zealand

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Date of publication: August 2006

This report was prepared for the Advisory Committee on Assisted Reproductive Technology by Alison Douglass. It is divided into two parts. Sections 1-4 explain the regulatory framework of the HART Act. Regulation is carried out in three ways: by prohibition of certain ART procedures and research, by an ethical review and policy framework, and through the establishment of an information-keeping regime for donors and donor off-spring.

The ethical review and policy framework is complex, partly due to the separation of the ethics and policy advice functions into two committees. The jurisdiction of the Ethics Committee (ECART) is limited to assisted reproductive procedures and human reproductive research covered by ACART’s guidelines or advice. Clarification of the relationship between the Ethics Committee and the Advisory Committee would assist the Advisory Committee in carrying out its functions to ensure that all relevant ART procedures and research are captured by the HART Act.

A potential regulatory gap exists where a new emerging technology is not an established procedure and does not fall within the activities regulated by the HART Act as it is neither prohibited nor a procedure which is covered by the guidelines or advice of the Advisory Committee. The report identifies the steps the Advisory Committee can take in identifying new technologies and providing advice when fulfilling its monitoring role under the Act.

Sections 5-10 provide an overview of the regulatory landscape within which the HART Act operates. There are a number of laws and multiple agencies that are relevant to assisted reproductive procedures and research, some of which overlap with the ethical review framework and functions of the Advisory Committee.

The HART Act has now aligned the regulation of providers of fertility services to the Health and Disability Services (Safety) Act 2001 through professional standards.

Regulation of health and disability research is covered by several pieces of legislation and bodies concerned with its oversight. The ethical review and advice framework in the HART Act operates largely independently of the ethical review system for health and disability ethics committees. The work of the Advisory Committee overlaps with the National Ethics Advisory Committee and there are other bodies which have an input into research policy and advice.

The development of policy on research on human embryos and human embryonic stem cells illustrates the overlap between the HART Act and other legislation. The jurisdictional boundaries between the HART Act and the Human Tissue Act, the Hazardous Substances and New Organisms Act, and the Medicines Act are discussed.

Consumer protection laws and how they impact on the rights of consumers of assisted reproductive technologies are discussed. These laws include: The Health Information Privacy Code, the Code of Health and Disability Consumers’ Rights and anti-discriminatory laws in the Human Rights Act and the New Zealand Bill of Rights Act. Some of these laws and codes apply not only to providers, but also to public bodies. The Advisory Committee will need to ensure compliance with anti-discriminatory laws when developing its guidelines and advice.

The family law framework provides a statutory regime for the protection of children born through assisted reproductive procedures. An overview is provided of the Care of Children Act (parenting orders and guardianship), the Status of Children Act (the legal status of children and their biological and social parents) and the Births, Deaths and Marriages Act (the Registrar-General’s role). The developments in this area of the law and the Law Commission’s recommendations for changes will be important for the Advisory Committee when revising its guidelines.

Document availability

This publication is available below in PDF and Word formats:

Report on the Regulatory Framework Governing Assisted Reproductive Technologies in New Zealand (Word, 317 KB)
Report on the Regulatory Framework Governing Assisted Reproductive Technologies in New Zealand (PDF, 311 KB)

Disclaimer

This report was prepared at the request of the New Zealand Ministry of Health. The intellectual property (including copyright) in the report is owned by the Crown and administered by the Ministry. The views of the author do not necessarily represent the views or policy of the New Zealand Ministry of Health nor those of the Advisory Committee on Assisted Reproductive Technology (ACART). The Ministry and ACART make no warranty, expressed or implied, nor assume any liability or responsibility for use of or reliance on the contents of this report.