Human Reproductive Technology (Licences and Registers) Regulations 1993

The Human Reproductive Technology Regulations 1993 (WA) set the procedural, evidentiary and fee rules that implement key licensing, exemption, register, warrant and authorised-officer provisions of the Human Reproductive Technology Act 1991 (the Act). Mechanically the Regulations prescribe: how an applicant seeks an exemption from licensing for artificial insemination (Forms, undertakings, fees and supporting evidence) (reg 2; Schedule Form 1); how practice and storage licence applications and renewals are lodged and the fees that must accompany those applications (reg 3); what particulars must appear in registers kept under the Act (reg 4); a fee for disclosure of information under s 46 of the Act and the circumstances in which that fee is waived (reg 4AA); the required form of a warrant under s 55(1) of the Act (reg 4A; Schedule Form 3); and the contents of identity certificates issued to authorised officers (reg 5; Schedule Form elements). The Regulations also record the place and form in which export-related records must be kept (reg 4(4)).

Procedurally, the Regulations make the Department the lodging point for exemption and licence applications (reg 2(1)(a); reg 3(1)), require documentary proof of medical qualification for exemptions (reg 2(1)(c)(ii)), and require undertakings from medical practitioners seeking exemptions (reg 2(1)(b); Schedule Form 1). They differentiate fees by type of licence and activity: practice licences ($1,800) and storage licences with three fee bands depending on whether sperm is collected on the premises and whether it is intended for donor insemination, and whether eggs or embryos are stored (reg 3(2) and (3)). Registers must record specific and often operational details such as names and addresses, licence kinds and dates, suspensions and conditions, responsible persons and monitoring outcomes (reg 4(1)-(3)). The Regulations also formally prescribe the warrant form (reg 4A) and the identity-certificate content for authorised officers (reg 5).

The instrument therefore translates broad powers and obligations in the Act (for example s 28 on exemptions, s 45 on registers, s 46 on disclosure, s 55 on warrants, s 59 on authorised officers) into concrete administrative mechanics: who pays which fees and when, what information is mandatorily recorded, what form official instruments and certificates must take, and what undertakings accompany exempt artificial insemination practices. Those mechanics determine immediate compliance costs, record-keeping burdens, and the administrative discretion points where the CEO or Minister make decisions (for example approval of register storage, imposition of licence conditions, suspension dates to be recorded). The Regulations also identify where other instruments interact with these mechanics, such as the Code and directions under s 31(1)(b) (reg 4(4)).

The Regulations operationalise several core concepts that appear in the Act. These are: exemptions for artificial insemination; licensing for practice and storage; registers and record-keeping; disclosure of information to third parties; warrants and authorised-officer identity; and fees. Understanding these concepts in the text is necessary to identify compliance triggers and administrative discretion.

Exemption from licensing for artificial insemination: A medical practitioner may apply for an exemption under s 28(1) of the Act. The Regulations require that the exemption application be lodged with the Department, be substantially in Schedule 1 Form 1, include a prescribed undertaking (Form 1), be accompanied by a $50 fee and evidence of medical qualification, and be signed (reg 2(1)(a)-(d)). If the exemption carries conditions, the certificate must use Schedule 1 Form 2 (reg 2(2)). The concept thus combines statutory power (s 28) with administrative formality and an express undertaking to comply with the Code and CEO directions (Schedule Form 1).

Licences: The Regulations require licence and renewal applications to be lodged with the Department (reg 3(1)) and fix fees: practice licence $1,800 (reg 3(2)); storage licence fees tiered to activity (reg 3(3)): $225 where sperm will not be collected at the premises or is not for donor insemination (3(3)(a)); $1,120 where donor sperm is to be collected (3(3)(b)); and $1,120 where eggs or embryos are to be stored (3(3)(c)). The different fee bands map to different regulatory burdens associated with collection and donor activity.

Registers and register content: The Regulations prescribe detailed entries for registers required under s 45(1)(b)(i) and (ii) and s 45(1)(d). For licences, entries must show licence-holder full name and address, kind of licence, grant and expiry dates, suspensions and periods, conditions and applicable periods, responsible persons and approved managers, premises address and dates/outcomes of monitoring or review (reg 4(1)). For exemptions, the register entries include exemption holder details, procedures covered, dates, suspension information, conditions, responsible persons and premises addresses (reg 4(2)). For disciplinary proceedings, the register entries capture the name of the person, kind of licence and premises, nature of alleged matters, types and dates of disciplinary action, summary determinations or consent, CEO-imposed warnings or penalties, allegations to the State Administrative Tribunal and outcomes, and reviews (reg 4(3)). The CEO is directed to keep export and follow-up use registers as required by the Code or by directions under s 31(1)(b) and by conditions (reg 4(4)).

The Regulations identify, by operation and by named categories, the parties who bear obligations or are affected by the administrative structure.

Medical practitioners and exempted practitioners: Medical practitioners who perform artificial insemination and seek an exemption from licensing under s 28(1) of the Act are directly affected. They must lodge an application with the Department, use Form 1 substantially, provide evidence of medical qualification and pay $50 (reg 2(1)). If exempted, they are subject to the conditions in s 33 of the Act and to any additional specific conditions recorded on the certificate in Form 2 (reg 2(2), Schedule Forms 1-2). Non-medical persons performing artificial insemination are affected where they do not need a licence only if they act under the direction of a licensee and provide a written undertaking to the licensee to furnish outcomes where donor sperm is used (reg 2(3)). That creates an obligation on the directing licensee to rely on a written undertaking from the person performing the procedure.

Licensees and potential licensees: Entities or individuals applying for practice licences and storage licences must lodge applications with the Department and pay the prescribed fees (reg 3). The fees are differentiated according to activity, which bears directly on cost modelling for clinics, laboratories and storage facilities (reg 3(2)-(3)). Licence-holders are the subjects of the registers in reg 4(1), which require public or departmental recording of licence particulars, responsible persons and the premises to which the licence relates.

Storage licensees and sperm/egg/embryo handlers: Storage licence-holders and entities exporting gametes or embryos are affected by reg 4(4), which requires the CEO to maintain registers for export and subsequent use as required by the Code or directions under s 31(1)(b). Storage licensees will be the primary recipients of outcome information required under undertakings in Form 1 when donor sperm is used (reg 2(1)(b)(ii) and Form 1(b)).

The Department and the CEO: The Department is the point of lodgement for applications (reg 2(1)(a); reg 3(1)). The CEO is given administrative duties: keeping registers (reg 4), issuing identity certificates for authorised officers (reg 5), and issuing certificates of exemption or imposing conditions (reg 2(2) and implied in the Act). The CEO also exercises functions relating to disciplinary actions recorded in registers (reg 4(3)(f), (g) and (l)).

Authorised officers and enforcement personnel: Persons authorised under the Act (and to whom s 59(2) applies) are issued certificates of identity under reg 5 that explicitly state whether the holder is given access to participant identifying information (reg 5(b)(iii)). These authorised officers exercise powers under s 55 which require a warrant in Form 3 if entry is to be authorised (reg 4A; Schedule Form 3).

The Regulations create specific duties and establish administrative rights that determine behaviour of regulated parties and regulators.

Duties on applicants for exemptions and licences:

• Exemption applicants: must lodge applications with the Department, complete Form 1 substantially, provide a $50 fee, evidence of medical qualification and sign the application (reg 2(1)(a)-(d); Schedule Form 1). Form 1 contains an explicit undertaking to observe and comply with the Code of Practice and any CEO direction, to furnish outcome details of donor insemination procedures to the storage licensee or the CEO, and to obtain effective consent from participants (Schedule Form 1). These are mandatory undertakings attached to the exemption application.
• Licence applicants: must lodge licence or renewal applications with the Department and pay the prescribed fee: $1,800 for practice licences (reg 3(2)) and storage licence fees as per the tiers in reg 3(3). These obligations are prerequisites to consideration of the application.

Record-keeping and register obligations:

• The CEO must cause registers to be kept in a place and manner approved by the Minister and ensure prescribed information is recorded for licences, exemptions and disciplinary proceedings (reg 4(1)-(3)). In particular the registers must include personal and operational information (for licences: full name and address of licensee, kind of licence, dates, suspensions, conditions, responsible persons, premises address, and monitoring outcomes (reg 4(1)); for exemptions: similar particulars attuned to the exemption context (reg 4(2)); for disciplinary proceedings: detailed allegations, actions taken, Tribunal outcomes and reviews (reg 4(3))). The CEO also must keep export-related registers as required by the Code or by direction (reg 4(4)).

Disclosure duties and fees:

• The CEO or Department must furnish information under s 46 of the Act but may charge the fee prescribed in reg 4AA(1) ($75). The fee is waived where the disclosure falls under s 46(2) or s 46(3)(a) (reg 4AA(2)). That creates a right for certain requesters to obtain information without payment and a corresponding revenue stream for other requests.

Warrant and inspection procedures:

• Entry under s 55(1) must be done by warrant in the form of Schedule Form 3 (reg 4A). The warrant authorises entry and the exercise of powers in s 55(2), and authorises the use of necessary force. It must specify the premises to be entered and note that the warrant continues until the purpose is satisfied (Schedule Form 3). This prescribes the procedural right to obtain judicial authorisation for entry and inspection and frames how enforcement powers are documented.

The Regulations themselves do not create new criminal penalties; rather they set the administrative machinery that triggers enforcement actions and record-keeping which support the statutory penalty and disciplinary framework in the Act. The enforcement architecture described by the Regulations is procedural and administrative, aligning powers of entry, identity of authorised officers, and the register content that records disciplinary outcomes.

Warrants for entry and enforcement actions: The Regulations prescribe the form of a warrant under s 55(1) (reg 4A; Schedule Form 3). The warrant authorises entry to premises with necessary assistance and the exercise of powers under s 55(2), and it explicitly authorises the use of such force as may be necessary (Schedule Form 3). By prescribing the warrant form the Regulations operationalise the Act’s entry and seizure powers, and ensure that enforcement actions are supported by a judicially issued instrument that contains particulars of suspected offences, the purpose of entry and the premises concerned.

Authorised officers and their identification: Regulation 5 sets the content of identity certificates for authorised officers and other persons to whom s 59(2) applies. The certificate must state whether the holder is generally authorised, is authorised only for specific functions or circumstances, and whether the holder is to be given access to participant identifying information. This creates an administrative control that limits enforcement personnel’s access to sensitive information. For investigative or compliance operations, authorised officers must carry the properly endorsed certificate, and enforcement actions taken without such authorised identification could be vulnerable to procedural challenge.

Registers recording disciplinary activity: Regulation 4(3) requires the register of disciplinary proceedings to include detailed entries: the nature of the alleged matters, disciplinary actions taken and their dates, whether summary determinations, warnings or penalties were imposed by the CEO, whether allegations were made to the State Administrative Tribunal and the outcomes, and the nature and outcomes of any review by the Tribunal (reg 4(3)(a)-(l)). These register entries create a public or administrative record of enforcement outcomes. The existence of a standing public or departmental record can have reputational consequences for licensees and individuals, and can be used as evidence in subsequent proceedings.

Monetary enforcement levers through fees: Regulation 4AA prescribes the fee ($75) for furnishing information under s 46, subject to waiver in specific statutory circumstances (reg 4AA(1)-(2)). While not a penalty, the fee acts as an administrative lever that can affect access to information and thereby the enforcement environment surrounding privacy and disclosure.

The Regulations function as subordinate legislation under the Human Reproductive Technology Act 1991 and operate in a regulatory network that includes the Act, the Code referenced by the Regulations, directions under statutory sections and tertiary instruments such as the State Administrative Tribunal’s jurisdiction. The text explicitly links regulatory duties to Act provisions and to other instruments.

Direct textual links to the Act: The Regulations repeatedly implement or assume powers given by specific Act sections: s 28(1) (exemptions) is operationalised by reg 2’s application and certificate forms (reg 2(1)-(2)); s 45(1)(b)(i) and (ii) and s 45(1)(d) (registers) are implemented by reg 4’s detailed content requirements (reg 4(1)-(3)); s 46 (furnishing information) is directly affected by reg 4AA’s fee and waiver scheme (reg 4AA(1)-(2)); s 55(1) (warrants) is tied to the prescribed warrant form in reg 4A and Schedule Form 3; and s 59(2) (persons to whom identity certificates apply) is linked to reg 5’s certificate content. These cross-references mean the Regulations must be read and applied in tandem with the Act to determine legal rights and liabilities.

Interaction with the Code of Practice and directions under s 31(1)(b): Regulation 2’s undertakings (Schedule Form 1) require the applicant to observe and comply with "the Code of Practice" and any direction from the CEO of the Department so far as it relates to the relevant artificial insemination procedure (reg 2(1)(b); Schedule Form 1(a)(i)-(ii)). Regulation 4(4) requires the CEO to keep registers of export and subsequent use of gametes, eggs in the process of fertilisation or embryos as may be required to be supplied "by any provision of the Code, by a direction given under section 31(1)(b), or by a condition imposed under any such provision or direction" (reg 4(4)). These provisions show the Regulations expect substantive operational detail to be contained in the Code and in CEO directions under s 31(1)(b), meaning compliance depends both on the Regulations and on non-statutory or administrative instruments and directions.

State Administrative Tribunal interplay: Regulation 4(3) is structured around disciplinary processes and requires registers to include whether allegations were made to the State Administrative Tribunal and the outcomes and reviews of Tribunal determinations (reg 4(3)(g)-(l)). This obliges the CEO and licensees to treat Tribunal proceedings as part of the administrative record and creates a reporting feedback loop between the Tribunal and regulatory registers.

Administrative fee provisions and broader fee regulation: The fee amounts in reg 3 and reg 4AA have been amended through a series of Health Regulations Amendment (Fees and Charges) Regulations (Compilation table). The Regulations therefore interact with the broader statutory and administrative regime governing health-sector fees in WA, and those external fee instruments are part of the legal environment that sets the precise financial obligations.

The Regulations include a documented amendment history in the compilation table which records changes to the instrument over time. The compilation table supplied in the Regulations lists successive amendments, their publication references and commencement dates. Notable amendment episodes recorded are:

• Initial instrument: Human Reproductive Technology (Licences and Registers) Regulations 1993, published 19 Mar 1993 and commenced 19 Mar 1993.
• 1995 Amendment Regulations: human reproductive technology (Licences and Registers) amendment regulations 1995, published 12 May 1995, commenced 12 May 1995 (gazette ref included in reg 4 amendments).
• 2004 Amendment: Changes published 30 Dec 2004 and commenced 1 Jan 2005 (Reg 4 amended, see compile notes).
• 2006 Amendment Regulations: Inserted reg 1A (definition of Department) and other text changes, published 15 Dec 2006, commenced 15 Dec 2006. Schedule Forms 1 and 2 were amended (notice in Forms).
• 2014 Amendment Regulations: Published 15 Jul 2014; commencement dates vary for different parts (r 1 and 2: 15 Jul 2014; other regulations: 16 Jul 2014).
• 2017, 2018, 2020, 2021, 2023, 2024 and 2025 Health Regulations Amendment (Fees and Charges) Regulations: These instruments repeatedly amended fee schedules and amounts in reg 3 and elsewhere (Compilation table entries: 2017, 2018, SL 2020/97, SL 2021/108, SL 2023/96, SL 2024/91, SL 2025/104). Specific fee updates to reg 3 are recorded with these instruments. For example, reg 3 shows a long list of amendments including the most recent SL 2025/104 r. 14.
• 2018 specific amendments: Human Reproductive Technology (Licences and Registers) Amendment Regulations 2018 were published 18 Sep 2018 and commenced: r 1 and 2: 18 Sep 2018; other regulations: 19 Sep 2018. These amendments included insertion of reg 4A (Form of warrant) and Schedule Form 3 (see reg 4A inserted: Gazette 18 Sep 2018 p. 3513).
• 2023 Amendment Regulations: Human Reproductive Technology Amendment Regulations 2023 SL 2023/5 inserted reg 4AA (fee for information under s 46) , inserted 27 Jan 2023 and other regs commenced 28 Jan 2023.

The compilation table appended to the Regulations records the precise gazette references and commencement dates that updated fees and forms over time. The Regulations’ body shows where specific amendments have been made, with marginal notes such as "[Regulation 4AA inserted: SL 2023/5 r. 4]" and "[Regulation 4A inserted: Gazette 18 Sep 2018 p. 3513]" signalling textual insertions and the amending instrument.

The text provided contains no references to judicial decisions, reported cases or litigation history under the Regulations. The compilation and notes do not list any court or Tribunal decisions nor do the Regulations themselves cite any case law. Accordingly, the Regulations’ file as supplied records no litigation outcomes or precedent interpretations.

That absence does not mean litigation cannot arise; the Regulations create enforcement processes that can give rise to administrative or judicial challenge. The Regulations explicitly refer to the State Administrative Tribunal in the context of disciplinary actions and reviews (reg 4(3)(g), (l)). The requirement to record whether allegations were made to the State Administrative Tribunal and the outcomes (reg 4(3)(g)-(l)) signals that administrative determinations under the Act are expected to be challenged at the Tribunal and that such outcomes should be captured in the register.

Potential litigation touchpoints implied by the Regulations (though no cases are named in the text) include:

• challenges to the validity of a warrant issued under s 55 where the warrant form or the process of issuance did not comply with procedural requirements (reg 4A; Schedule Form 3);
• disputes over whether the CEO properly exercised discretion to issue or condition an exemption certificate (reg 2(2), Schedule Form 2) or to impose a suspension or conditions recorded on a register (reg 4(1)(d)-(e));
• challenges arising from the scope of authorised officers’ access to participant identifying information where reg 5 prescribes that access is explicitly noted on identity certificates (reg 5(b)(iii)), potentially involving privacy obligations under other legislation;
• disputes over whether a fee for information under s 46 is correctly charged or waived in specific circumstances in light of reg 4AA(1)-(2);
• appeals or reviews of disciplinary actions taken by the CEO and recorded in the register, which the Regulations anticipate will be the subject of Tribunal allegations and outcomes (reg 4(3)(f)-(l)).

Because the compilation table and the Regulations do not list cases, counsel and researchers must consult external legal databases and Tribunal records for any litigation involving these Regulations or the Act. The Regulations themselves provide the procedural architecture that will be central to litigation records (e.g. register entries, warrants, identity certificates) but do not include litigation history in their text.

The Regulations contain several technical details that can produce non-obvious compliance pitfalls for practitioners and licensees. These are practical points where failure to follow the prescribed form, timing or content can create administrative non-compliance, data gaps or enforcement exposure.

Forms and "substantial accordance": Exemption applications must be "in writing, substantially in accordance with Schedule 1 Form 1" (reg 2(1)(b)). The phrase "substantially in accordance" may be read as allowing limited deviation, but the Regulations also require specific undertakings and evidentiary attachments (reg 2(1)(c)-(d) and Schedule Form 1). Practitioners should not omit the undertaking language or required attachments (fee, proof of medical qualification, signature) expecting a generous interpretation. The prescribed Form 2 must be used for exemptions "in respect to which conditions are to be imposed" (reg 2(2)); failing to use the correct form could create administrative uncertainty.

Fee bands and activity definitions for storage licences: Storage licence fees are tiered: $225 where sperm is not to be collected at the premises or where sperm collected is not intended for donor insemination; $1,120 where donor sperm is to be collected at the premises; and $1,120 if eggs or embryos are stored (reg 3(3)(a)-(c)). An administrative gotcha is that a single premises might fall into multiple categories depending on intended use, and if applicant contemporaneously adds donor collection or egg/embryo storage to operations, the fee exposure can change. The Regulations do not spell out whether pro rata adjustments or retrospective fees apply on operational changes; practitioners should assume the higher fee band applies where the activity falls within it.

Written undertakings for non-medical practitioners: A person other than a medical practitioner who carries out artificial insemination does not need a licence or exemption only if they act under the direction of a licensee and, where donor sperm is used, give a written undertaking to the licensee to furnish outcome details (reg 2(3)). The scope and sufficiency of that written undertaking are not elaborated; absent a standard template, disputes may arise as to whether the undertaking provides the required detail or is timely. Licensees directing non-medical persons should obtain and retain the undertaking in writing and ensure it contains the detail necessary to furnish the outcome information requested.

Register content specificity and privacy risk: The prescribed registers require recording full names and addresses of licensees and exemption holders, and in disciplinary registers the "nature of the matters alleged" and outcomes (reg 4(1)-(3)). For entities handling sensitive participant or donor data, the obligation to record detailed disciplinary information can raise privacy compliance issues with other statutes. Moreover, reg 5 requires identity certificates to show whether the authorised officer may be given access to participant identifying information (reg 5(b)(iii)); failure to correctly grant or withhold that access in practice could lead to unauthorised disclosure.

The Regulations prescribe concrete steps and documentation. Below is a compliance checklist and recommended procedures to meet the main regulatory requirements.

1. Know the lodgement point and contacts

• All exemption and licence applications and renewals must be lodged with the Department (reg 2(1)(a); reg 3(1)). Record the Department contact details from the current Department of Health communications channels and confirm any electronic lodgement processes where available.

2. Exemption applications (medical practitioners)

• Use Schedule Form 1 substantially as drafted (reg 2(1)(b); Schedule Form 1). Do not omit the undertaking text. The application must:
  • Be in writing and signed by the applicant (reg 2(1)(b), (d));
  • Include evidence of medical qualification (reg 2(1)(c)(ii));
  • Include payment of the $50 fee (reg 2(1)(c)(i)).
• The Form 1 undertaking requires:
  • Compliance with the Code of Practice and any CEO direction relating to the procedure (Schedule Form 1(a));
  • Furnishing outcome details of donor insemination to the storage licensee or the CEO (Schedule Form 1(b));
  • Compliance with effective consent requirements under the Act (Schedule Form 1(c)).
• Keep copies of the signed form and evidence of fee payment and qualification in a retrievable compliance file.

3. Licence applications and renewals

• Lodge applications and renewals with the Department (reg 3(1)). Ensure fee payment accompanies the application:
  • Practice licence: $1,800 (reg 3(2));
  • Storage licence: assess which fee band applies and pay the correct fee (reg 3(3)(a)-(c)). Where donor sperm is to be collected at the premises or eggs/embryos stored the fee will be higher ($1,120 bands). If in doubt, obtain an early departmental ruling on the applicable band and retain written confirmation.
• For storage licences, document whether sperm will be collected at the premises and whether donor insemination is intended, and ensure applications reflect intended operations.

4. Record-keeping and registers

• Maintain internal registers and record systems that capture all fields required by reg 4(1)-(3) so the CEO can be supplied consistent data: