Human Reproductive Technology Act 1991

The Act defines several foundational terms. Human embryo is defined in section 3A as a live embryo that has a human genome or an altered human genome and has been developing for less than eight weeks since the appearance of two pronuclei or the initiation of its development by other means; any period when development is suspended is disregarded. Fertilisation means the process that commences at the moment of inclusion of a sperm head within the plasma membrane of an egg and is completed when an embryo is formed. Artificial fertilisation procedure includes both artificial insemination and in vitro fertilisation (IVF) procedures. In vitro fertilisation procedure is defined broadly to cover any procedure consequent upon the removal of a human egg from a woman’s body for fertilisation, keeping, or use, or directed at introducing an egg, fertilising egg, or embryo into a woman, and includes prescribed procedures.

Participant means a person who undergoes a procedure, is a donor or recipient of gametes or embryos, or from whom a consent is required. Effective consent is governed by section 22(8): it must be in writing, any conditions must be met, it must not have been withdrawn, and the gametes or embryo must be kept and used in accordance with it. Excess ART embryo (defined in section 53T) is a human embryo created by ART for treatment of a woman that is excess to the needs of the woman and her spouse or de facto partner at the time of creation; it becomes excess when each responsible person has given written authority for use for another purpose or has determined in writing that it is excess.

The Council is the Western Australian Reproductive Technology Council, composed of 10 nominated members and an Executive Officer (s.8). Its functions include advising the Minister and CEO, compiling and amending the Code of Practice, approving research projects, and promoting informed public debate. The Code of Practice is divided into Part 1 (Rules having legislative effect) and Part 2 (guidelines). Rules must be published in the Gazette and laid before Parliament before coming into operation. Directions may be given by the CEO under Part 4 Division 2. Licence (under Part 4) means a storage licence, practice licence, or both. NHMRC licence means a licence granted under Part 4B or under the Commonwealth Human Embryo Act. Person to whom the licence applies includes the licensee, licence supervisor, designated persons, and persons acting under their direction. The Act also distinguishes between storage procedures (keeping gametes or embryos by cryopreservation or other means that temporarily arrest metabolic function) and other ART procedures.

The Act directly affects a wide range of individuals and organisations. Licensees , persons or bodies holding a storage or practice licence under Part 4 , are the primary duty-holders. They include the licence supervisor, the individual under whose supervision the authorised practice is carried on. Medical practitioners who perform artificial insemination may hold an exemption under section 28, and are deemed licence supervisors. Persons who hold an NHMRC licence or an exemption under section 28A for storing excess ART embryos are also affected.

Participants in ART procedures , including women undergoing treatment, donors of human eggs or sperm, recipients, and their spouses or de facto partners , have rights and obligations regarding consents and access to information. Biological parents (genetic contributors) and children born as a result of ART are subject to the confidentiality and record-keeping provisions. The Act also affects bodies corporate and proprietary companies that hold licences; directors and persons occupying positions of authority may be personally liable (s.53). Employees and agents of licensees may be deemed liable for contraventions (s.52).

The Western Australian Reproductive Technology Council and the CEO (the Chief Executive Officer under the Health Legislation Administration Act 1984) have central roles. The CEO administers the licensing system and may give directions. Authorised officers , including Public Health Officials and persons appointed under section 59 , have powers of entry, inspection, and seizure. The State Administrative Tribunal reviews decisions and can impose disciplinary penalties.

At the Commonwealth level, the NHMRC Licensing Committee performs functions under Part 4B, including issuing licences for use of excess ART embryos, and inspectors appointed by the Committee have monitoring powers. Human Research Ethics Committees (HRECs) assess and approve research projects involving excess ART embryos. The Act also binds the Crown (s.3(10)).

Licensees have extensive duties. They must obtain a licence before carrying out any storage of gametes or embryos, any IVF procedure, or any other use of a human embryo outside the body for non-treatment purposes (s.6). Every licence is subject to conditions set out in section 33: the practice must be carried on under the supervision of the licence supervisor, only on specified premises, and in accordance with the Act, the Code, and any directions. Licensees must ensure participants receive proper counselling and relevant information, and that effective consents are obtained and recorded. They must maintain proper records showing the identity and consent of donors, biological parentage, supply and recipient details, procedure outcomes, and research activities (s.44). These records must be retained for the prescribed number of years and made available to authorised officers. Licensees must also furnish annual returns and reports to the CEO (s.47) and comply with any conditions or directions.

Rights of gamete providers and participants are set out in Part 3 Division 3. Under section 25, all rights in human gametes remain vested in the providers as personal property, subject to the prohibition on commercial trading (s.53Q). Where gametes are donated with effective consent, rights vest in the licensee but only for specified purposes (initiating IVF, artificial insemination, approved research, or diagnostic procedures). Section 26 governs rights in a human egg undergoing fertilisation or embryo outside the body: each person on whose behalf it is developed has the right to decide how it is dealt with, subject to section 53Q. In the event of death of one member of a couple, rights vest solely in the survivor. On commencement of implantation, rights vest in the woman receiving it.

Participants have a right of access to information about themselves held by a licensee (s.46). A person may, on payment of a fee, obtain information from the CEO’s registers that does not identify a biological parent or child, or that identifies a biological parent or child in limited circumstances (s.46(3)). Children born as a result of ART who have reached 16 years of age may obtain identifying information about the donor, subject to conditions including approved counselling (s.49(2d)-(2f)). Persons with a conscientious objection to using excess ART embryos are not required to use or assist in using them under Part 4B (s.53ZVA). The CEO must afford an applicant or licensee reasons for determinations and a reasonable opportunity to show cause before refusing a licence, imposing conditions, or suspending or cancelling a licence (s.13(8), s.42).

The Act creates several tiers of offences. Under Part 1 Division 2, unlicensed practices (s.6) are a crime punishable by imprisonment for five years (or one year on summary conviction). Additional daily penalties of $10,000 may apply if a notice of continuing contravention is served. There is no defence that the accused believed the conduct was authorised by a licence or consent (s.6(5)). Contravening the prohibition on research without Council approval (s.7(1)) is likewise a crime punishable by five years’ imprisonment. Licensees who keep or use gametes or embryos in contravention of the Act, or fail to comply with certain directions, commit an offence punishable by two years’ imprisonment (s.7(5)).

Part 4A creates serious offences. Creating a human embryo clone (s.53C), placing it in a human or animal (s.53D), or importing/exporting it (s.53E) carries a penalty of 900 penalty units (as defined by Commonwealth Crimes Act 1914 s.4AA) or 15 years’ imprisonment or both. Other prohibited practices , such as creating an embryo other than by fertilisation (s.53G), creating an embryo for a purpose other than achieving pregnancy (s.53H), developing an embryo for more than 14 days (s.53J), heritable genome alterations (s.53L), collecting a viable embryo from a woman’s body (s.53M), creating chimeric or hybrid embryos (s.53N), placing embryos improperly (s.53O), importing/exporting prohibited embryos (s.53P), and commercial trading in gametes or embryos (s.53Q) , carry penalties up to 600 penalty units or 10 years’ imprisonment (or 120 penalty units or two years on summary conviction).

Part 4B offences: using an excess ART embryo without a licence or exempt use (s.53W) is a crime punishable by 300 penalty units or five years’ imprisonment (60 penalty units or 12 months on summary conviction). Breaching a licence condition (s.53X) carries the same penalty. Confidential commercial information offences under section 53ZK attract 120 penalty units or two years’ imprisonment.

Disciplinary action is available under Part 4 Division 3 for matters such as improper conduct of practice, contravention of a condition or direction, conviction of an offence, unsuitability of premises, or jeopardy to public health (s.39). The CEO may make a summary determination (s.37) after seeking the advice of the Council, imposing penalties including reprimand, imposition or variation of conditions, requirements for undertakings or bonds, or requirements for specified action. If the person does not consent or a higher penalty is appropriate, the CEO may refer the matter to the State Administrative Tribunal (s.38). The Tribunal may impose penalties including suspension or cancellation of a licence, disqualification, or a monetary penalty (s.40(1a)). Where a licence is held by a proprietary company, penalties may be imposed on directors or shareholders (s.40(2)). Immediate suspension may be ordered for public health reasons under section 36(2a), with referral to the Tribunal within 14 days.

Enforcement powers are conferred on authorised officers under Part 5. They may enter and inspect premises where gametes, embryos, or procedures are kept or carried out, examine records, and take possession of anything believed to be required for licensing or evidence (s.54). Entry outside reasonable times requires written recorded grounds. A warrant from a justice is required for search and seizure, and may authorise arrest (s.55). The Act includes robust evidentiary provisions: averments in a prosecution notice are accepted as proved in the absence of proof to the contrary (s.57), and certificates signed by the CEO are admissible as evidence of various matters.

The Act explicitly interacts with several Commonwealth and State laws. It defines Commonwealth Human Embryo Act as the Research Involving Human Embryos Act 2002 (Cth), and Part 4B contains provisions similar to that Act (s.53S). The NHMRC Licensing Committee established under that Commonwealth Act performs functions under Part 4B, including issuing licences for use of excess ART embryos (ss.53Y-53Z). Section 53U provides that the Committee or an officer of the Commonwealth is not precluded by any State law from performing functions conferred by this Part. Section 53V clarifies that the Part does not impose duties beyond the State’s legislative power.

Part 4A (prohibited practices) largely mirrors the Commonwealth Prohibition of Human Cloning Act 2002, and section 53A states its object is to adopt a uniform Australian approach. Review of Part 4A must take into account the Commonwealth review under that Act (s.53R). Section 53T defines corresponding law to include the Commonwealth Act and Acts of other States that are corresponding State laws.

The Act also interfaces with the Surrogacy Act 2008 (WA). Section 18(1)(ca) allows the Code to make provision for artificial fertilisation procedures for implementing a surrogacy arrangement as defined in that Act. Section 23(1)(a)(iii) permits IVF for a woman who is unable to give birth due to medical reasons and is a party to a lawful surrogacy arrangement.

The Health Practitioner Regulation National Law (Western Australia) is referenced in the definition of medical practitioner (s.3(1)). The Children and Community Services Act 2004 is referenced concerning authorised officers and nominations for the Council (s.8(2)(a)(i)(E)). The State Administrative Tribunal (Conferral of Jurisdiction) Amendment and Repeal Act 2004 conferred jurisdiction on the SAT for reviews and disciplinary matters; relevant transitional provisions are noted.

The Interpretation Act 1984 applies to directions published in the Gazette (s.3(8)), and section 13D concerning bankruptcy is incorporated (s.29(4), Sch. cl.5(1)(b)). The Criminal Code definition of summary conviction penalty applies (s.3(1)). The Public Sector Management Act 1994 governs staff appointments and use of facilities (ss.58, 59). The Financial Management Act 2006 requires annual reports to be combined where practicable (Sch. cl.11(2)(c)).

The Act was originally enacted as No. 22 of 1991 and assented to on 8 October 1991. It commenced in stages: Part 1 Division 1 (except ss.1-2), Part 2, Part 6 and the Schedule on 6 March 1992; Part 1 Division 2, Parts 3-5 on 8 April 1993. Significant amendments include the Human Reproductive Technology Amendment Act 1996 (No. 1 of 1996), which amended storage provisions and clarified commencement. The Acts Amendment (Lesbian and Gay Law Reform) Act 2002 (No. 3 of 2002) amended sections 21, 23, 24, 26, and the preamble to remove provisions that discriminated on the basis of sexual orientation, allowing de facto couples of opposite sex and later same-sex female couples (see section 23(1)(c) as amended). The Human Reproductive Technology Amendment Act 2004 (No. 17 of 2004) inserted Part 4B regulating excess ART embryos, added definitions, and made extensive changes to licensing, consent, and confidentiality provisions. The Acts Amendment (Prohibition of Human Cloning and Other Practices) Act 2004 (No. 18 of 2004) inserted Part 4A with prohibitions on human cloning and other practices, and also amended sections 3, 53ZG, and 53ZP.

The State Administrative Tribunal (Conferral of Jurisdiction) Amendment and Repeal Act 2004 (No. 55 of 2004) replaced references to the former Licensing Authority with the State Administrative Tribunal, amended disciplinary provisions, and changed review rights. The Criminal Procedure and Appeals (Consequential and Other Provisions) Act 2004 (No. 84 of 2004) updated penalty and procedural references. The Machinery of Government (Miscellaneous Amendments) Act 2006 (No. 28 of 2006) substituted “CEO” for “Commissioner of Health” and made consequential changes. The Surrogacy Act 2008 (No. 47 of 2008) amended sections 18 and 23 to recognise surrogacy arrangements. The Public Health (Consequential Provisions) Act 2016 (No. 19 of 2016) amended sections 39 and inserted section 60A concerning Public Health Officials. An uncommenced amendment, the Assisted Reproductive Technology and Surrogacy Act 2025 (No. 19 of 2025), Part 17 Division 11, is yet to be proclaimed.

The Act does not itself document specific court cases, but it establishes several mechanisms for judicial and tribunal review. Under section 42, a person aggrieved by a decision of the CEO , such as refusal of a licence, imposition of conditions, suspension or cancellation , may apply to the State Administrative Tribunal for review. The Tribunal’s decisions on disciplinary matters (ss.38-40) are reviewable. Section 43 allows the Tribunal to restrain continuing contraventions and to order suspension or cancellation. For decisions of the NHMRC Licensing Committee under Part 4B, section 53ZM provides for review by the Commonwealth Administrative Appeals Tribunal, subject to the Administrative Appeals Tribunal Act 1975 and section 43 of the Commonwealth Human Embryo Act.

The evidentiary provisions in section 57 facilitate proof in proceedings. Notably, an averment in a prosecution notice that a substance was a human embryo, or that a person was licensed, is accepted as proved in the absence of proof to the contrary (s.57(1)). Certificate evidence from the CEO is admissible (s.57(4)-(10)). Proceedings for a simple offence are instituted in the name of the CEO and dealt with by a magistrate (s.56). A prosecution may be commenced until five years after the alleged offence (s.56(2)). No specific reported cases are cited in the Act, but the availability of review mechanisms suggests that licensees and applicants have challenged decisions before the SAT and the AAT.

Several provisions pose particular traps for the unwary. Unlicensed practice is a strict liability crime: section 6(5) expressly provides that it is no defence to allege a belief that what was done was authorised by a licence or exemption, or done at the request or with the consent of a participant. This means a person cannot rely on a mistaken belief in the existence of a licence. Consents cannot be varied or withdrawn once the gametes, egg or embryo have been used (s.22(4)). This applies even if circumstances change, so participants must be fully informed before giving consent. Storage limits are strictly capped: no human egg undergoing fertilisation or human embryo may be stored for more than 10 years without Council approval, which may only be granted for special reasons before the expiry of the current storage period (s.24(1)-(1c)). Licensees must notify persons three months before the end of the storage period (s.24(3)), and if no extension is sought, the embryo may be allowed to succumb without liability (s.24(4)). Mixing multiple sources in one procedure is prohibited: section 17 requires the Code to prohibit mixing multiple sources of gametes, eggs undergoing fertilisation, or embryos in a manner that could confuse biological parentage.

Commercial trading in human eggs, sperm, or embryos is a crime under section 53Q, with penalties up to 10 years’ imprisonment. The definition of “valuable consideration” is broad, including any inducement, discount, or priority in service provision, but not reasonable expenses for collection, storage, transport, or transport of excess ART embryos after they become excess. The 14-day rule for embryo development outside the body (s.53J) applies regardless of whether the embryo could survive; any development beyond 14 days (excluding suspended periods) is a crime. Heritable genome alterations are prohibited (s.53L) even if intended for therapeutic purposes, unless future amendments permit.

For licensees, the Code of Practice has legislative force: failure to comply with the Rules may be relied on to establish liability, and failure to have regard to the guidelines may tend to establish liability (s.15(4)). The CEO may take into account a tendency not to regard guidelines when considering an application. Conditions may be imposed after a licence is granted without the licensee’s consent, and they take effect on the date specified in the notice (s.35). A contravention of a condition or direction is not an offence unless regulations so provide (s.34), but it can lead to disciplinary action, including suspension or cancellation. The licence supervisor is personally liable for contraventions and may be deemed to have committed an offence unless they prove they gave appropriate directions and exercised supervision (s.53(1)(b)). Directors and officers of body corporate licensees may be personally liable for offences (s.53(1)(a)).

Confidentiality obligations are stringent: divulging identifying information about donors, participants, or children is an offence punishable by $5,000 or 12 months’ imprisonment (s.49). Exceptions are limited and require consent or authorised purposes. Even for children seeking donor information, restrictions apply depending on whether the donation occurred before or after the commencement of the 2004 amendments (s.49(2e)). False or misleading statements in applications, returns, or records attract a $5,000 penalty (s.50), and altering or destroying records is likewise an offence.

A person or body wishing to conduct ART procedures in Western Australia must first obtain the appropriate licence under Part 4. The application (s.29) must be made to the CEO in writing, accompanied by the prescribed fee and supporting information. The CEO will investigate the applicant’s background and antecedents, and will not grant a licence unless satisfied that every person to whom the licence would apply is a fit and proper person, that the applicant is accredited by the Reproductive Technology Accreditation Committee of the Fertility Society of Australia (or a prescribed alternative), that adequate premises, equipment, staff, and facilities are available, and that the licence is needed to fulfil a genuine social need (s.29(5)). The applicant must also satisfy the CEO as to the character, qualifications and experience of the proposed licence supervisor, past compliance with the Act, counselling arrangements, and record-keeping.

Once licensed, the licensee must operate strictly within the scope of the licence. Storage licences authorise storage of gametes, embryos, and approved research; practice licences authorise artificial fertilisation procedures and approved research (s.27). The licence supervisor must supervise the practice, ensure other persons subject to the licence are suitable, ensure proper equipment and procedures, and comply with all terms, conditions and directions (s.51). The licensee must adhere to the mandatory conditions in section 33: practice only on the specified premises, permit entry and inspection by authorised officers, provide participants with counselling and information, obtain and record effective consents, maintain records, maintain accreditation, and provide copies of records or information to the CEO as directed.

Consent procedures under section 22 must be followed meticulously. Gametes must not be used or stored without effective consent from the donor. Embryos may not be stored or used without effective consent from each person whose gametes were used and, where applicable, the woman on whose behalf the embryo is being developed and her spouse or de facto partner. Consents must be in writing, specify purposes and conditions, and cannot be varied once the gametes or embryo have been used. Licensees must also ensure that counselling is provided and that participants understand the implications of the procedure and the effect of the consent provisions.

Records must be made and kept as prescribed by section 44, including identity and consent of donors, biological parentage, dates, supply and recipient details, and outcomes. Records must be retained for the prescribed number of years and made available to authorised officers. Annual returns must be furnished to the CEO (s.47). Confidentiality of identifying information must be maintained; disclosure is only permitted in the circumstances set out in section 49.

For research involving human embryos, the licensee must obtain prior approval from the Council under section 20. Research on embryos cannot be conducted unless it is for a purpose relating to the woman’s treatment and unlikely to leave the embryo unfit for implantation, or consists of an exempt use under Part 4B (s.14(2a)). For research on excess ART embryos, a separate licence from the NHMRC Licensing Committee is required under Part 4B, and the applicant must comply with the conditions in section 53ZE, including obtaining proper consent from responsible persons and reporting to the Committee.

Prohibited practices under Part 4A must be avoided at all times. The Act prohibits human cloning, creation of embryos other than by fertilisation, creation of embryos for non-pregnancy purposes, development beyond 14 days, heritable genome alterations, collection of viable embryos from a woman’s body, creation of chimeric or hybrid embryos, improper placement of embryos, and commercial trading. These are serious crimes and carry heavy penalties. Licence holders should implement internal compliance programs, train staff on the prohibitions, and ensure that no activities cross these boundaries.

Finally, licensees must cooperate with authorised officers (s.54) and the CEO, and respond promptly to any notices of proposed disciplinary action or variation of licence conditions. Any decision of the CEO that is adverse may be reviewed by the State Administrative Tribunal (s.42). For matters arising under Part 4B, review is by the Commonwealth Administrative Appeals Tribunal (s.53ZM). Conscientious objection under section 53ZVA allows a person to refuse to use or assist in using excess ART embryos without penalty under the Act, but this does not relieve a licensee from their own obligations to ensure compliance by others.