Variation in Sex Characteristics (Restricted Medical Treatment) Regulation 2023

The central concept in the regulation is the excluded condition. Section 3 lists five conditions that are not “variation in sex characteristics” under the Act. This is a carve-out. The regulation uses narrow drafting: hypospadias is excluded only if it is “other than proximal hypospadias with cryptorchidism.” That means the subset of proximal hypospadias with cryptorchidism remains within the Act’s definition and is subject to its full restrictions. Bladder exstrophy, epispadias (a related condition), PCOS, and undescended testis are wholly excluded. The exclusion is significant because these are relatively common conditions - particularly hypospadias and undescended testis - that would otherwise fall under the Act’s regime of requiring authorisation before treatment.

A second core concept is temporary restricted medical treatment. Vaginal dilation is the only treatment prescribed in this category (s 4). The Act defines “restricted medical treatment” and includes a subset that is “temporary”; the regulation names a specific procedure. Vaginal dilation is often performed as part of treatment for certain variations, especially in conditions such as Mayer-Rokitansky-Küster-Hauser syndrome. Classifying it as temporary rather than permanent affects the authorisation pathway and duration of oversight.

The assessment board is another key concept. The regulation does not create the board - the Act does - but it sets qualification criteria for its members. The board has five categories; the regulation addresses three of them. For the medicine category (s 6), appointees must have qualifications or expertise in at least one listed area: adolescent and young adult medicine, clinical genetics, general paediatrics, neonatology, paediatric endocrinology, paediatric or adolescent gynaecology, or paediatric urology. Notably, the list is entirely paediatric and adolescent; there is no provision for adult specialists. For the variation in sex characteristics category (s 7), appointees must have lived experience, with examples including a person with a variation or a parent or carer. For the psychosocial support category (s 8), appointees must have qualifications or experience in psychological support, social work services, counselling (including genetic counselling), or support or care for the psychosocial needs of people with a variation.

The final concept is reportable treatment. Section 10 prescribes the same five conditions from s 3 as reportable treatments. The Act already has its own definition of reportable treatment; the regulation adds these conditions to that definition. This means that even though those conditions are not subject to the Act’s restriction on medical treatment, any medical treatment performed on a person with one of those conditions must be reported to the relevant authority (the details of which are set out in s 9). This dual status - excluded from restriction but subject to reporting - creates an additional compliance burden that clinicians and hospitals must manage.

The regulation directly affects several distinct groups. First and most immediately, medical practitioners who treat patients with any of the conditions listed in ss 3 and 10 must understand which conditions are excluded from the Act’s restrictions and which are not. For a paediatric urologist, proximal hypospadias with cryptorchidism is not excluded, meaning that surgery on a child with that condition would be a restricted medical treatment requiring authorisation from the assessment board. For a general surgeon repairing bladder exstrophy, the treatment is not restricted but must be reported. For a gynaecologist prescribing vaginal dilation for a patient with MRKH syndrome, that procedure is a temporary restricted medical treatment, which carries its own authorisation and oversight pathway under the Act.

Second, parents and carers of children with variations in sex characteristics are directly affected. Those with children diagnosed with an excluded condition face a lower regulatory burden (only reporting), but may still be subject to oversight and questioning from clinicians about compliance with reporting requirements. Those with children with conditions not excluded face the full Act, which restricts when and how medical treatment can be provided. The regulation’s distinction between proximal hypospadias with cryptorchidism and other hypospadias creates a sharp line: a child with a mild distal hypospadias is not subject to the Act’s restrictions, while a child with a proximal hypospadias accompanied by undescended testes (cryptorchidism) is, despite the second condition being itself an excluded condition.

Third, the regulation affects individuals who serve or may be appointed to the assessment board or assessment committee. The board’s medicine category requires specific paediatric subspecialties; that limits the pool of potential appointees to those who hold such qualifications. The lived-experience category is broad, allowing parents and carers as well as individuals with variations. The psychosocial support category covers a range of professions, including genetic counsellors. Committee members have a duty to keep minutes (s 5), which imposes an administrative burden.

Fourth, hospitals, clinics, and health departments must adapt their systems to capture and report the data required by s 9 for reportable treatments. Because the excluded conditions are still reportable, every treatment for hypospadias (except proximal with cryptorchidism), bladder exstrophy, epispadias, PCOS, and undescended testis must be documented and reported with details and start date. That is a significant data-collection exercise that may not have existed before.

Fifth, the ACT Government and its agencies are affected through the cost of administering the board and committee, managing the reporting database, and ensuring compliance. The regulation does not appropriate funds, but the obligations it imposes (minutes, board criteria, reporting) carry resource implications that must be met from public revenue.

The regulation creates few direct duties, partly because the Act itself contains the primary obligations. The duties that exist are ancillary but carry practical weight. The most explicit duty is on any assessment committee: it must keep minutes of its meetings (s 5). This is an administrative obligation with a clear evidentiary purpose. Minutes would record deliberations, decisions, and reasons, and could be used in any subsequent review or litigation. The duty is not qualified - it applies to every meeting.

A second duty arises from s 10 read together with s 9. Anyone who performs a “reportable treatment” must report that treatment. The regulation defines reportable treatment for this purpose to include the five excluded conditions. The content of the report must include “details of each reportable treatment undertaken” and the date the treatment started (s 9(1)). “Details” is not defined, leaving discretion to the administering authority (likely the minister or health department) to specify the required information in guidelines or forms. The duty to report applies to a broad range of treatments for common conditions. For example, orchidopexy for undescended testis or clomiphene for PCOS would trigger the reporting obligation if performed under a diagnosis of that condition.

A third duty, implied rather than explicit, is on those who appoint members to the assessment board to ensure that appointees meet the criteria in ss 6-8. If an appointment is made that does not satisfy the criteria, it may be invalid or open to challenge. The regulation does not prescribe who makes the appointments; that is left to the Act. But the criteria are mandatory: a person appointed for the medicine category “must have qualifications or expertise in at least 1 of” the listed areas. The use of “must” creates a legal standard. For the lived-experience category, the requirement is open-ended, with examples given. For psychosocial support, the categories are also mandatory but flexible.

Rights are less prominent. The regulation does not confer any new rights on patients or practitioners. However, it can be read as limiting the rights of practitioners who would otherwise treat without restriction. By classifying vaginal dilation as a temporary restricted medical treatment, the regulation subjects that procedure to whatever authorisation requirements the Act imposes. A practitioner’s right to perform vaginal dilation is no longer unfettered - it is contingent on compliance with the Act’s mechanisms. Similarly, treating proximal hypospadias with cryptorchidism is restricted, whereas treating other hypospadias is not. The regulation therefore creates differential rights depending on the specific diagnosis. Patients have no right under the regulation to demand treatment; the regulation’s structure is purely restrictive and administrative.

The regulation itself does not create any offences or penalties. The Act under which it is made is the source of penal provisions. However, the regulation’s requirements are enforceable because non-compliance with a regulation made under an Act is typically itself an offence under the Act’s general provisions or under the Legislation Act 2001. The republication note at the front of the regulation states that, at the republication date, a penalty unit is $160 for an individual and $810 for a corporation. That provides a baseline for any offence under the Act that specifies a penalty in units, but the regulation does not reference those figures.

Enforcement likely flows from the Act’s provisions concerning restricted medical treatment, reporting, and board procedures. If a practitioner performs a restricted medical treatment without the required authorisation, that would be an offence under the Act, not the regulation. If a practitioner fails to report a reportable treatment (such as a hypospadias repair), that failure could constitute an offence under s 43 of the Act, as the regulation defines which treatments are reportable. The note to s 10 explicitly flags that the excluded conditions are “still subject to reporting requirements in the Act, s 43 and s 44.” Sections 43 and 44 of the Act presumably create obligations and penalties for non reporting.

The assessment committee’s duty to keep minutes (s 5) is enforceable indirectly. If the committee fails to keep minutes and a dispute arises about a decision, the absence of minutes could lead to adverse findings in an administrative review or to a direction from the minister to comply. The Act may contain a general power to enforce the regulation’s requirements, and a failure to comply could be grounds for removal of committee members.

Practically, enforcement will rely on the ACT health regulator or the responsible minister monitoring compliance. The reporting requirement under s 9 provides a mechanism for the government to collect data; that data could be used to identify practitioners who are not reporting or who are performing restricted treatments without authorisation. The regulation does not create an inspectorate or investigative powers; those are presumably in the Act.

Because the regulation has been in force only since late 2023 (with the reporting provisions commencing a year later in December 2024), there has been little time for enforcement action to build. Practitioners should expect that initial enforcement will focus on education and compliance, but penalties for deliberate non-compliance could be significant given that the Act touches on sensitive medical procedures involving children and vulnerable adults.

The regulation is made under the Variation in Sex Characteristics (Restricted Medical Treatment) Act 2023, and its primary interaction is with that Act. It defines key terms and fills procedural gaps left by the Act. For example, the Act defines “variation in sex characteristics” but allows conditions to be excluded by regulation; s 3 of the regulation does that. The Act defines “restricted medical treatment” and allows temporary treatments to be prescribed; s 4 does that. The Act sets up the assessment board and allows criteria to be prescribed; ss 6-8 do that. The Act provides for reporting of treatment and allows additional reportable treatments to be prescribed; ss 9-10 do that.

The regulation also interacts with the Legislation Act 2001. That Act governs the making, commencement, republication, and interpretation of subordinate laws. The regulation is subject to its provisions. For instance, s 2 of the regulation (commencement) was omitted under s 89(4) of the Legislation Act, which deals with standard commencement provisions. The endnotes reference this. The republication itself is done under the Legislation Act’s authority.

The regulation may interact with health practitioner regulation laws, such as the Health Practitioner Regulation National Law (ACT). If a practitioner performs restricted medical treatment without authorisation, that could constitute professional misconduct or unsatisfactory professional conduct under the National Law. The reporting data gathered under s 9 may also be shared with other health bodies, though the regulation does not specify this. The Privacy Act 1988 (Cth) and the Health Records (Privacy and Access) Act 1997 (ACT) would apply to the handling of patient information collected through reporting. The regulation does not contain any privacy safeguards; those would be found in other legislation.

The regulation’s relationship with criminal law is minimal but not zero. If a treatment performed without authorisation causes harm, the practitioner could face assault charges. The regulation does not change the criminal law, but it creates an administrative framework that may be relevant in criminal proceedings (e.g., proving that a treatment was not authorised).

Internationally, the regulation aligns with a growing number of jurisdictions that have enacted restrictions on medical treatment for variations in sex characteristics. However, it does not interact directly with any federal law, as healthcare regulation is primarily a state and territory matter in Australia. The federal Medicare Benefits Schedule may cease to cover procedures that are restricted by the Act, but that is not addressed in the regulation.

The regulation has a minimal amendment history. It was notified on the ACT legislation register on 14 December 2023 as SL2023-35. Sections 1 and 2 commenced on that date. Section 9 (reporting treatment information) commenced on 23 December 2024, a full year later. All other sections commenced on 23 December 2023. The delayed commencement for s 9 gave practitioners and hospitals time to prepare their reporting systems.

The only amendment recorded is the omission of section 2 (commencement) by operation of the Legislation Act 2001, section 89(4). This is a standard editorial change that occurs when a regulation’s commencement provisions are no longer needed after full commencement. The omission does not change the substance. There have been no substantive amendments, no insertions, and no repeal of any provisions. The regulation remains in its original form.

The republication history shows two republications: R1 on 23 December 2023 (effective 23 December 2023 to 22 December 2024) and R2 on 23 December 2024 (effective from 23 December 2024 onward). R2 was issued to reflect the commencement of s 9 and to incorporate the editorial removal of s 2. There are no earlier republications noted.

Because the regulation is new and has not been amended, there is no track record of government revisions to tighten or loosen the criteria. Future amendments could expand the list of excluded conditions, add more temporary restricted treatments, change board membership criteria, or alter reporting requirements. Given the political sensitivity of the subject matter, any amendment would likely attract public and parliamentary scrutiny.

The regulation itself has not been the subject of any reported litigation, according to the source material. The endnotes contain no references to court decisions, and the regulation is too recent for significant case law to have developed. The reporting requirements only commenced in December 2024, so there has been little time for disputes to arise.

However, the Act under which the regulation is made could generate litigation in the future. Challenges could come from several directions. Parents of children with variations might challenge a refusal by the assessment board to authorise treatment, arguing that the board’s membership does not comply with the regulation’s criteria (e.g., that the medicine category appointee lacks the required expertise). Conversely, advocacy groups might challenge an authorisation on the basis that the board lacked a member with lived experience as required by s 7. The regulation’s criteria for board membership could become the subject of judicial review proceedings if an appointment is made that arguably does not meet the required qualifications.

Another potential area of litigation involves the scope of the excluded conditions. If a practitioner treats a child for hypospadias that turns out to be proximal with cryptorchidism, and does not seek authorisation because they mistakenly believed the condition was excluded, the practitioner could face prosecution. The regulation’s precise definition of hypospadias exclusions creates a bright line that is medically complex. Disputes could arise over whether a particular case of cryptorchidism is present or whether the hypospadias is truly “proximal.” Expert evidence would be needed.

The regulation’s reporting requirements could also lead to litigation if a practitioner fails to report a treatment and is penalised, arguing that the treatment was not for the excluded condition but for an unrelated reason. The phrase “details of each reportable treatment undertaken” is vague, and a practitioner might argue that the reporting obligation only applies if the treatment is directly for the condition, not for a secondary issue.

As of the republication date, no such cases appear in the ACT courts. Practitioners should be aware that the regulation is untested, and that early compliance is the safest course while the legal boundaries remain uncertain.

Several features of this regulation are likely to catch out practitioners, administrators, and even board members.

First, the carve-out for hypospadias is highly specific. Hypospadias is excluded, but only if it is “other than proximal hypospadias with cryptorchidism.” This means that a child with a mild distal hypospadias is excluded, but a child with proximal hypospadias that happens to also have undescended testis is not excluded - even though undescended testis itself is an excluded condition. A practitioner who sees a patient with proximal hypospadias and cryptorchidism must treat the condition as a variation in sex characteristics, requiring authorisation for any surgical correction. The presence of two excluded conditions together (proximal hypospadias and undescended testis) creates a non-excluded condition. The logic is not obvious and is easy to miss.

Second, the excluded conditions remain reportable. A surgeon repairing a straightforward distal hypospadias may think the Act does not apply at all. But s 10 makes that repair a “reportable treatment,” meaning the surgeon must report details and the start date. The regulation does not specify who receives the report, how to submit it, or what “details” means. Practitioners who ignore this reporting requirement because they assume the exclusion absolves them of any obligation under the Act face potential penalty.

Third, vaginal dilation is prescribed as a temporary restricted medical treatment. This may surprise gynaecologists and sexual health practitioners who have long performed this procedure as a routine clinical intervention without oversight. From the commencement date, vaginal dilation in the ACT became subject to whatever authorisation pathway the Act prescribes for temporary treatments. The regulation does not define “temporary,” and it is unclear whether a single dilation session is covered or only a course of treatment.

Fourth, the board membership criteria for the medicine category are exclusively paediatric and adolescent. There is no provision for a specialist in adult endocrinology, adult urology, or adult gynaecology. This may be appropriate for treating children, but many people with variations in sex characteristics are adults. If an adult seeks authorisation for a restricted medical treatment, the board must include a person with expertise in paediatric subspecialties but not necessarily adult medicine. That mismatch could lead to board decisions that lack appropriate adult medical perspective.

Fifth, the lived-experience category includes “a parent of, or carer for, a person with a variation in sex characteristics.” This means a board member could be a parent whose perspective may conflict with the patient’s own wishes, especially in cases involving older children or adults. The regulation does not require that the appointee have personal lived experience; parental experience suffices. This may dilute the intended voice of those directly affected.

Sixth, the reporting requirement under s 9 only asks for “details of each reportable treatment undertaken” and the start date. It does not require the patient’s identity, outcome, referring doctor, or any follow-up information. The vagueness creates both a low compliance burden and a high risk of insufficient data for regulatory oversight. Critics may argue the reporting is too minimal to be useful.

Compliance starts with classification. Any medical practitioner treating a patient for a condition related to sex characteristics must first determine whether the condition falls within the Act’s definition of “variation in sex characteristics.” The regulation provides the list of excluded conditions in s 3. If the condition is one of the five listed (and in the case of hypospadias, it is not proximal hypospadias with cryptorchidism), then the condition is not a variation in sex characteristics. That means the Act’s restriction on medical treatment does not apply. However, the practitioner must still comply with the reporting requirement.

For reporting, the practitioner must record “details of each reportable treatment undertaken” and the date the treatment started (s 9). The regulation does not specify the form or recipient of the report. Practitioners should contact the ACT Health Directorate or the responsible minister’s department to obtain the approved form or reporting portal. The information to be provided will likely include the patient’s identifier (subject to privacy laws), the specific diagnosis from the excluded list, and the nature of the treatment. Reports should be submitted promptly after treatment commences.

If the condition is not excluded - if it is a variation in sex characteristics under the Act - then the practitioner must comply with the Act’s restrictions. That means obtaining authorisation from the assessment board before performing any restricted medical treatment. The regulation does not set out the authorisation process; that is in the Act. However, the regulation provides the criteria for board membership, which may be relevant if a practitioner wishes to challenge the composition of the board or seek a review of its decision.

For vaginal dilation, the procedure is classified as a temporary restricted medical treatment (s 4). Practitioners must follow the Act’s provisions for temporary treatments, which likely involve a different (possibly faster) authorisation pathway than for permanent treatments. The regulation does not detail that pathway, so practitioners should familiarise themselves with the Act’s sections governing temporary restricted medical treatment.

Assessment committees must keep minutes of all meetings (s 5). This is a simple but critical administrative step. Minutes should record attendance, decisions made, reasons for decisions, and any dissenting views. The Act may require minutes to be provided to the minister or published; the regulation does not say. The safest approach is to maintain minutes in a secure format and retain them permanently.

Those appointed to the assessment board must ensure they meet the criteria for their category. A person appointed to the medicine category should have qualifications or expertise in one of the listed paediatric or adolescent fields. Lived-experience appointees should be prepared to disclose their connection to a variation in sex characteristics. Psychosocial support appointees should have qualifications or experience in the listed disciplines.

Finally, the commencement date of each provision matters. Most provisions commenced on 23 December 2023, but s 9 (reporting) commenced on 23 December 2024. Any reportable treatment performed before that date did not need to be reported under this regulation (though the Act may have had transitional provisions). From 23 December 2024 onward, reporting is mandatory. Practitioners who treated conditions like hypospadias or undescended testis in the intervening year should ensure they are now reporting ongoing treatments or new treatments promptly.