Regulation of ART in New Zealand What have we got and how did we get there

1. Regulation of ART in New ZealandWhat have we got and how did we get there Sylvia Rumball Chair, Advisory Committee on Assisted Reproductive Technology

2. Summary Points • Characteristics of New Zealand society • Policy positions • Events leading up to the passing of legislation • Regulation prior to the passing of legislation • Outline of legislation:purposes, principles, prohibitions,oversight mechanisms • Current work • Challenges from access to fertility treatment in other countries • Experience as Chair

3. Characteristics of New Zealand Society • Committed to equality (women’s suffrage 1893) • Treaty between Crown and Maori in 1840 gives Maori special status • Secular-low church attendance • Liberal • Small with highly networked population • Highly mobile population (the OE is part of life for young people), eyes turned to outside world

4. Characteristics of New Zealand society (2) • Ethnically-diverse population, growing Polynesian group • Political spectrum lacks extremes • Transparent and open • Low level of corruption and high respect for rule of law • Quick uptake of new technology

5. Some relevant policy positions • Use of genetic modification and cloning in plants and animals restricted • Nuclear free • Abortion accepted • Commitment across policy area to access to information about biological origins • Commitment to donations of blood, tissue, gametes, embryos being gifts and not commercial transactions

6. Key events prior to passing of ART legislation • 1981 Auckland Infertility Society established • 1983 IVF became available • 1984 First child born in NZ using ART • 1985 Ministry of Justice report on New Birth Technologies • 1986 Establishment of Interdepartmental Monitoring Committee on ART • 1989 New Zealand Infertility Society established • 1993 National Ethics Committee on Assisted Human Reproduction established

7. Key Events continued • 1994 Report of the Ministerial Committee on Assisted Reproductive Technologies • 1997 Private member’s Bill introduced • 1998 Government Bill introduced • 1999 Women’s Health Action Trust Discussion Document “Protecting our Future” • 2004 Human Assisted Reproductive Technology Act passed

8. Regulation in period prior to legislation • Voluntary adherence to professional guidelines by fertility clinics • National system of ethics committees for approval of research • 1990 Accreditation by Australasian Reproductive Technologies Accreditation Committee (ANZCART) of first NZ clinic • Clinics required approval by the National Committee on Assisted Human Reproduction (NECAHR) for certain ART procedures • NECAHR approval was on a case-by-case basis

9. Other relevant legislation • Human Rights Act 1993 • Contraception, Sterilisation and Abortion Act 1997 • Care of Children Act • Code of Health and Disability Consumers Rights 1996 • Privacy Act and Health Information Privacy Code 1993

10. Characteristics of the HART Act • Purposes include • Securing the benefits of Art for individuals and society in general but with appropriate protections • Prohibiting unacceptable procedures • Prohibiting certain commercial transactions • Providing a robust and flexible framework for regulation • Ensuring ethics committee approval of various procedures • Establishing an information-keeping regime

11. Principles of HART Act • Seven guiding principles which concern; • Health and well-being of children born as a result of ART • Health and well-being of women in use of procedures • Requirement for informed consent • Access to information by children about their origins • Consideration of needs, values and beliefs of Maori • Consideration of ethical, spiritual and cultural beliefs present in society

12. Outline of Act • Prohibits certain procedures • Allows particular procedures (established procedures) to proceed without further approval • Creates a group of procedures which require ethics committee approval according to guidelines • Creates two committees, an Advisory Committee which will establish guidelines and provide advice and an ethics committee which does case-by-case approvals • Establishes an auditing system of fertility clinics against a Fertility Services Standard • Establishes a register for information about donors

13. Current Work • Guidelines for extension of storage of gametes and embryos • Advice to Government on: import and export of gametes and embryos informed consent issues in ART posthumous reproduction access to ART

14. Challenges from the use of fertility treatment in other countries • Pressure to use gametes sourced in countries allowing anonymity and commercial supply • Pressure to import embryos created from gametes obtained commercially and/or without record of biological origins • Inter-country surrogacies leading to problems over citizenship, immigration and adoption • Concerns about exporting gametes and/or embryos to countries with different standards

15. Experience as Chair • Advice to the Government mostly accepted (no decision yet on advice on research using embryos) • Ministers of Health served under varied in their comfort level with area and with their desire for interaction with the Committee • Membership of Cabinet and political climate impacts on their reception to some advice eg re research • Over time increased emphasis on the health and well-being of the potential child as opposed to the rights of the adult parties