Wednesday, 14 August 2024

Health Legislation Amendment (Regulatory Reform) Bill 2024

Statement of compatibility

Mary-Anne THOMAS (Macedon – Leader of the House, Minister for Health, Minister for Health Infrastructure, Minister for Ambulance Services) (10:54): In accordance with the Charter of Human Rights and Responsibilities Act 2006, I table a statement of compatibility in relation to the Health Legislation Amendment (Regulatory Reform) Bill 2024:

In accordance with section 28 of the Charter of Human Rights and Responsibilities Act 2006 (the Charter), I make this statement of compatibility with respect to the Health Legislation (Regulatory Reform) Bill 2024 (the Bill).

In my opinion, the Bill, as introduced to the Legislative Assembly, is compatible with the human rights protected by the Charter. I base my opinion on the reasons outlined in this statement.

Overview of the Bill

The Bill has two main purposes – firstly, to amend seven Acts to provide a modern, streamlined, best practice set of compliance and enforcement tools to enable the Department of Health’s Health Regulator to apply a graduated, proportionate and risk-based approach to health regulation in Victoria and to better minimise and prevent the risk of harm to health or safety in Victoria. Secondly, the Bill will amend the Assisted Reproductive Treatment Act 2008 (ART Act) to transfer some of the powers and functions of the Victorian Assisted Reproductive Treatment Authority (VARTA) to the Secretary of the Department of Health and remove other functions from the ART Act. VARTA will then cease as a statutory authority.

The Bill will amend legislation (the relevant health legislation) in order to implement a baseline compliance and enforcement regulatory toolkit (regulatory toolkit) across various health regulation schemes in Victoria. The regulatory toolkit will comprise powers to:

• issue improvement and prohibition notices;

• accept enforceable undertakings;

• issue infringement notices for prescribed offences; and

• issue information or document production notices.

These powers will be conferred on the Secretary of the Department of Health, and in some cases, authorised officers (Health Regulator). These powers, where appropriate and necessary, will be accompanied by additional supporting amendments, including offences for non-compliance or providing false or misleading information, external review rights and service of document provisions. These ensure the powers will operate as intended.

The following legislation will be amended to provide for or amend components of the full regulatory toolkit for the Health Regulator:

• Clause 74 amends the ART Act which regulates the use of assisted reproductive treatment (and artificial insemination other than self-insemination) in Victoria;

• Clause 89 amends the Drugs, Poisons and Controlled Substances Act 1981 (DPCS Act) which regulates the obtaining, possession, use, administration, prescription, sale, supply or manufacture of medicines and poisons;

• Clause 93 amends the Health Services Act 1988 which regulates private hospitals and day procedure centres and establishes the minimum requirements for the safety and quality of patient care in these health service establishments; and

• Clause 101 amends the Non-Emergency Patient Transport and First Aid Services Act 2003 (NPTFAS Act) which regulates non-emergency patient transport service providers and commercial first aid services providers to promote safe and appropriate services.

Together, these clauses will be referred to as the full regulatory toolkit clauses.

The following legislation will be amended to introduce certain elements of the regulatory toolkit:

• Clause 104 amends the Public Health and Wellbeing Act 2008 (PHW Act) to introduce enforceable undertakings and information or document production notices for the regulation of pest control operators, cooling towers and water delivery systems;

• Clause 108 amends the Radiation Act 2005 to introduce enforceable undertakings and information or document production notices in the regulation of radiation practices and the use of radiation sources; and

• Clause 110 amends the Safe Drinking Water Act 2003 to introduce the issuing of infringement notices in the regulation of the supply of drinking water.

The ART Act will also be further amended to:

• Transfer VARTA’s regulatory powers and functions to the Secretary;

• Establish the Donor Conception Registrar, who will have responsibility for managing the Central Register and Voluntary Register (the Donor Registers);

• Transfer VARTA’s donor registry functions to the Donor Conception Registrar;

• Remove mandatory requirements relating to counselling that apply before information on the Donor Registers may be accessed or a contact preference lodged;

• Require the Donor Conception Registrar to provide explanatory materials to persons who are currently required to undertake, or be offered, counselling before information on the Donor Registers may be accessed or a contact preference lodged;

• Require a person applying for information from the Donor Registers to provide a ‘statement of reasons’ for applying, which is provided by the Donor Conception Registrar to a person whose consent is required before information can be disclosed;

• Remove provisions regarding donor-linking services;

• Replace the requirement for pre-approval by VARTA of the movement of donor gametes or embryos formed using donor gametes (donor formed embryos) into and out of Victoria with a certification process regulated by the Secretary;

• Provide for regulation making powers to prohibit, or place conditions or requirements on, the movement of donor gametes and donor formed embryos into and out of Victoria in certain circumstances; and

• Broaden the power to impose conditions on the registration of assisted reproductive treatment providers (ART providers).

Consequential amendments will also be required to the Human Tissue Act 1982 and the Births, Deaths and Marriages Act 2004 (BDM Act).

Human rights issues

Abolition of VARTA

The amendments to the ART Act will abolish VARTA and transfer some of its functions and powers to the new Donor Conception Registrar and to the Secretary. Other functions currently performed by VARTA will be removed from the Act. The Bill provides for VARTA’s property, rights, liabilities and staff to transfer to the Secretary. The Bill does not alter the content of these property rights, liabilities or other interests, and both the Secretary and the Donor Conception Registrar (once established) will be subject to the obligations under the Charter for public authorities.

Among the transfer of VARTA’s powers to the Secretary include powers of entry on to the premises of ART providers, and the seizure of documents under s 119 of the ART Act. The Bill will not materially alter the content of existing interferences with the rights to privacy or property, which I consider to be appropriately prescribed and compatible with the Charter.

The Bill will also remove the legislative requirement for VARTA to provide public education about treatment procedures and the best interests of children born as a result, and the requirements that counselling be offered or undertaken before disclosure of information from the registers or lodgement of a contact preference. Current requirements relating to minors will remain in the Act – where a minor applies to access information from the registers, or is eligible to lodge a contact preference, and they do not have the consent of their parent or guardian, then before the information is disclosed or preference lodged they must have received counselling by a suitably qualified practitioner, who must have confirmed the minor is sufficiently mature. As the removal of these services do not constitute any direct interference with Charter rights nor are relevant to any of the State’s positive obligations to protect rights, I am of the view that these amendments do not engage the Charter.

Additionally, the Bill will remove the requirement for the provision of donor-linking services; the facilitation of contact between donors and donor conceived persons; from the ART Act. While this service promoted the right to the protection of families and children (s 17), privacy (s 13) and freedom of expression (s 15), by assisting donor conceived persons to potentially make contact with their donor or other genetic relatives, the repeal of the donor-linking provisions of the ART Act does not interfere with these rights for the purpose of the Charter. Donor conceived persons, their parents, and donors themselves will still be able to access relevant information from the Donor Registers, which will be managed by the new Donor Conception Registrar, and may use this information to make contact with their donors or donor conceived children. I am therefore satisfied that the repeal of the donor-linking provisions does not limit rights under the Charter.

Regulatory toolkit

The establishment of the regulatory toolkit by the Bill in the relevant health legislation, including the ART Act, is intended to improve health outcomes in Victoria by preventing and minimising the risk of harm to health or safety. The new regulatory tools will replace VARTA’s oversight of ART providers with a greater range of compliance and enforcement mechanisms, that may instead be utilised by the Secretary or their delegates.

The following rights are relevant to the Bill:

• Right to freedom from forced work (s 11)

• Privacy and reputation (s 13)

• Freedom of expression (s 15)

• Fair hearing (s 24)

• Presumption of innocence (s 25(1))

• Protection from self-incrimination (s 25(2)(k))

• Right not to be tried or punished more than once (s 26)

Right to freedom from forced work

Section 11 of the Charter provides that a person must not be held in slavery or servitude, or made to perform forced or compulsory labour. ‘Forced or compulsory labour’ does not relevantly include any work or service that forms part of normal civil obligations.

The full regulatory toolkit clauses of the Bill amend the relevant health legislation to give the Health Regulator the power to issue improvement and prohibition notices, and to accept enforceable undertakings. Clauses 104 and 108 amend the PHW Act and Radiation Act respectively, to give the Health Regulator the power to accept enforceable undertakings.

Improvement Notices

The improvement notices require a regulated person who the Health Regulator reasonably believes has contravened, is contravening or is likely to contravene a provision of the relevant legislation or regulations or a condition of a permission, to take specific action, within a specified timeframe, to rectify the contravention, or to cease the contravention, or to prevent a likely contravention from occurring, or to address the matters or activities that caused the contravention. It is an offence to then contravene an improvement notice without reasonable excuse.

Prohibition Notices

Prohibition notices allow the Health Regulator to prohibit a regulated person from engaging in a specified activity if the Health Regulator reasonably believes the regulated person has contravened, is contravening or is likely to contravene the relevant legislation or regulations or a condition of a permission, and prohibiting the conduct or activity is necessary to prevent or minimise the risk of harm to health or safety. Additionally, the Health Regulator may require the person subject to the prohibition notice to take any specified action the Health Regulator reasonably believes is necessary to prevent or minimise the risk of harm to health or safety, or to rectify or cease the contravention, or prevent a likely contravention from occurring or to address the matters or activities that caused the contravention.

Enforceable undertakings

The Health Regulator will have the power to accept enforceable undertakings given by a regulated person relating to a contravention or alleged contravention of the relevant legislation or regulations. The regulated person undertakes to take certain action, or refrain from taking certain action, in order to comply with the relevant legislation or regulations. In turn, no criminal proceeding may be commenced against the person for the contravention or alleged contravention of the relevant legislation or regulations if the enforceable undertaking is complied with, and while it is in force.

Analysis

The compulsion to undertake an activity or to ‘do’ something as required by an improvement notice, or as may be required in a prohibition notice or enforceable undertaking, may interfere with the right to freedom from forced work, specifically the prohibition on compulsory labour in s 11(2) of the Charter. I am of the view, however, that the right is not engaged, as any required work or action would fall within the scope of the exception to the prohibition in s 11(3) of the Charter, namely work or service that ‘forms part of normal civil obligations.’ The improvement and prohibition notices and enforceable undertakings can only be given to regulated persons or entities (or those acting on their behalf) who are engaging in a regulated activity and have voluntarily assumed associated responsibilities and obligations. Additionally, the required action or work serves a protective or remedial purpose, being to stop, mitigate or remedy conduct that poses health or safety risks.

If the exception in s 11(3) does not in fact apply, and the right is engaged, I am of the view that any limit on the right is reasonable and proportionate to the legitimate aims of protecting health or safety in Victoria. Any limitation of rights will also be mitigated by various safeguards, including review of an improvement or prohibition notice by VCAT, while enforceable undertakings may only be enforced by the Health Regulator obtaining an order from the Magistrates’ Court.

Accordingly, I am satisfied these provisions are compatible with the Charter.

Right to privacy and reputation

Section 13(a) of the Charter provides that a person has the right not to have their privacy unlawfully or arbitrarily interfered with. An interference will be lawful if it is permitted by a law which is precise and appropriately circumscribed, and will be arbitrary only if it is capricious, unpredictable, unjust or unreasonable, in the sense of being disproportionate to the legitimate aim sought.

Section 13(b) of the Charter provides that a person has the right not to have their reputation unlawfully attacked. An ‘attack’ on reputation will be lawful if it is permitted by an appropriately circumscribed law.

Information or document production notices

The full regulatory toolkit clauses and clauses 104 and 108 of the Bill, amend the relevant health legislation to empower the Health Regulator to issue a notice for the production of information or documents, which may include health or personal information. An offence for contravention of an information or document production notice has been included in the Bill, as has an offence for providing false or misleading information.

The information or document production notice provisions may interfere with the right to privacy, given they can compel the production of information or documents that may contain personal or sensitive information. However, in my view, any resulting interference will be lawful and not arbitrary, for the following reasons.

First, any interference in a person’s private sphere will be limited by the scope of the powers, which only require production of information or documents relevant to monitoring compliance with the relevant health legislation and whether a person has committed a relevant offence. To issue an information or document production notice in the first place, the Health Regulator must first reasonably believe the information or document is in the person’s knowledge, possession or control and the information is, or the document contains information that is, necessary for monitoring a regulated person’s compliance with the relevant Act or regulations or determining whether an offence has been committed. This threshold limits the personal or health information that would be disclosed.

Secondly, the information or document production notice serves the important purpose of ensuring compliance with legislation that protects health or safety. Safeguards are also included in the Bill including that certain required matters are to be included in a notice, a right of review of an information or document production notice by the Victorian Civil and Administrative Tribunal (VCAT), and a reasonable excuse defence in the offence provisions.

Finally, the production of information and documents under the changes to the relevant health legislation will also be subject to the privacy principles in the Privacy and Data Protection Act 2014 and Health Records Act ‍2001 in relation to how personal and health information is collected, handled and disclosed. These requirements impose additional safeguards to ensure that personal and health information collected through a document the subject of an information or document production notice is dealt with appropriately.

I therefore consider that the production of information and documents provisions in the Bill are compatible with the right to privacy.

Publication or display of improvement or prohibition notices, enforceable undertakings or the failure to comply with enforceable undertakings

The full regulatory toolkit clauses of the Bill include provisions allowing the Health Regulator to require a person, to whom an improvement notice or prohibition notice is given, to display a copy of the notice in a specified manner. These clauses, and clauses 104 and 108 of the Bill relating to enforceable undertakings, also contain a provision allowing the Health Regulator to publish details of an enforceable undertaking on the Department’s Internet site. Further, if the Health Regulator obtains an order from the Magistrates’ Court for the enforcement of an enforceable undertaking, and a person is found in contempt of court for contravening such an order, the Health Regulator may publicise this contravention on the Department’s Internet site.

The display or publication of a person’s contravention of a provision of an Act, regulations or a permission or an enforceable undertaking may interfere with the right to privacy (including the right not to have one’s reputation unlawfully attacked under s 13(b) of the Charter). However, I do not consider that this right would be limited, as the publication of information that might constitute an ‘attack on reputation’ is pursuant to properly circumscribed law, and in the case of enforceable undertakings, follows appropriate judicial oversight of the person’s non-compliance with the enforceable undertaking. Further, the legislation aims to protect Victorian health or safety – including protecting the safety of those undertaking assisted reproductive treatment, and regulating health services, medicines and poisons – and the publication of non-compliance with relevant court orders is necessary and proportionate to fulfil this important purpose.

Improvement and prohibition notices and enforceable undertakings

The improvement and prohibition notices and enforceable undertaking powers may also interfere with the right to privacy, as they may compel a person to ‘do’ something. I am of the view, however, that the right to privacy is not limited, as the requirements to undertake a specified activity will largely fall outside of a person’s private sphere and therefore the scope of the right. Where prohibition notices or enforceable undertakings prevent a person from working and forming relationships at work, such that the privacy right may be interfered with, the interference is minimal, and is not arbitrary, as it is in accordance with a law that is proportionate to the legitimate purpose of minimising the risk of harm to health or safety.

Statement of reasons before release of information by the Donor Conception Registrar

Clause 16 of the Bill amends s 56(3) of the ART Act to require applicants for information on the Central Register to include a written statement of reasons with their application. This application will be made to the Donor Conception Registrar, who must in turn provide the applicant with prescribed explanatory material. Clause 54 then inserts new s 67AA into the ART Act, which provides that an applicant’s statement of reasons must be given to a person who needs to consent to the release of information on the Central Register. Clause ‍62 of the Bill then amends s 72 of the ART Act to require that a person who needs to consent to disclosure of information from the Voluntary Register must also be given the applicant’s statement of reasons, in addition to prescribed explanatory material. So, if for example, a parent of a donor conceived person applies for information from the Central Register regarding a donor, they must provide a statement of reasons with their application, which will then be provided to the donor by the Donor Conception Registrar, before they may then consent to the release of the information.

The requirement for the disclosure of a statement of reasons to another person, such as a donor, engages the right to privacy. However, I do not consider that the right is limited, as any interference with privacy is not arbitrary, as it would be pursuant to a properly circumscribed law that is proportionate to its purpose of enabling the safe disclosure of information to people involved in donor conception treatment, and allowing people to identify and make contact with their genetic relatives. The Donor Conception Registrar will be responsible for receiving and then disclosing the statement of reasons, so will act as an intermediary between the two parties and will have a role in safeguarding privacy. Further, a person will only be required to provide the statement of reasons if they voluntarily decide to seek information from the Donor Registers, and the information will be subject to the confidentiality protections set out in sections 66A and 66C of the ART Act.

Accordingly, I am of the view that clause 16 of the Bill is compatible with the right to privacy.

Certification requirement for the movement of donor gametes and donor formed embryos into and out of Victoria

Clause 6 of the Bill amends s 36 of the ART Act to permit a person to bring donor gametes or donor formed embryos into or take them out of Victoria if they provide a certification to the Secretary that attests certain requirements have been complied with. These matters include that the relevant donor has given consent for the movement, storage and use of their gametes or the donor formed embryos, that the donor has received counselling, and that the donor has provided information required to be kept on the Donor Registers. Although the process of certification does not require any personal or health information to be disclosed, clause 6 also inserts a new section 36D into the ART Act which requires the certifying person to keep a written record of the matters certified by that person under section 36. New section 36D(2), which requires the certifying person to keep written records of the prescribed matters for a prescribed period after the certification is made is an offence provision. It is likely that the certifying person will be required to keep records of the personal and health information of donors of gametes in order to comply with section 36D. This may constitute an interference with the right to privacy.

I am of the view, however, that the privacy right will not be limited, as any interference will be pursuant to a properly circumscribed law, and will be proportionate to the legitimate purpose of regulating the use, and maintaining the safety of, donor material used in assisted reproductive treatment.

Right to freedom of expression

Section 15(2) of the Charter provides that every person has the right to freedom of expression, which includes the freedom to seek, receive and impart information and ideas of all kinds. However, section 15(3) provides that special duties and responsibilities attach to this right, which may be subject to lawful restrictions reasonably necessary to respect the rights and reputations of others, or for the protection of national security, public order, public health or public morality.

Offence to provide false or misleading information

The full regulatory toolkit clauses, and clauses 104 and 108 regarding information or document production notices, include provisions making it an offence to provide false or misleading information.

These offence provisions might be considered to amount to an interference with freedom of expression, in particular, the right to impart ideas. However, this right is qualified in that it may be subject to restrictions that protect public order, health and safety or the rights of others. In this case, the Bill aims to protect the health or safety of Victorians by strengthening compliance and enforcement mechanisms of various regulated health related areas such as assisted reproductive treatment. The offence provision supports the power of the Health Regulator to require regulated persons to provide information or documents that relate to potential contraventions of the relevant health legislation. The information or documents need to be true and accurate in order for the Health Regulator to monitor compliance with the legislation, and ultimately protect the health or safety of Victorians.

Accordingly, I am of the view that the offence provisions for the information or document production notices in the Bill fall within the qualification of the right, such that the right to freedom of expression is not limited.

Fair hearing

Section 24(1) of the Charter relevantly provides that a party to a civil proceeding has the right to have the charge or proceeding decided by a competent, independent and impartial court or tribunal after a fair and public hearing. The concept of a ‘civil proceeding’ is not limited to judicial decision-makers, but may encompass the decision-making procedures of many types of tribunals, boards and other administrative decision-makers with the power to determine private rights and interests. The right may be limited if a person faces a procedural barrier to bringing their case before a court, or where procedural fairness is not provided. However, the entire decision-making process, including reviews and appeals, must be examined in order to determine whether the right is limited.

Improvement, prohibition and information or document production notices and enforceable undertakings

While the improvement and prohibition notices, production of information and documents notices and enforceable undertakings mechanisms may interfere with the fair hearing right, as they may be imposed on a person unilaterally and impact their rights and interests by requiring them to ‘do’ or ‘not do’ a certain thing, I am of the view that the right is not limited. This is because procedural fairness safeguards have been included in the Bill, including the right of review of the notices by VCAT, and oversight of the enforcement of enforceable undertakings by the Magistrates’ Court. The Bill also requires the notices to contain detailed information pertaining to the conduct that is alleged to have contravened the relevant legislation and that has prompted the issue of the notice, as well as information regarding the person’s review rights.

I am therefore satisfied that the improvement, prohibition and information or document production notice provisions of the Bill, and the enforceable undertaking provisions, are compatible with the right to a fair hearing under the Charter.

Specific conditions to be imposed on ART providers

Clause 66 of the Bill inserts s 75A into the ART Act to empower the Secretary to impose specific conditions on the registration of a registered ART provider relating to any matter relevant to their provision of services. A specific condition is distinct from the prescribed general conditions imposed on all registered ART providers following the amendment of s 75 of the ART Act, also by clause 66 of the Bill. Clause 66 then inserts new s 75D into the ART Act to make it an offence for an ART provider to contravene a general or specific condition of registration.

The imposition of specific conditions of registration on ART providers without a hearing, the contravention of which is a criminal offence, is relevant to the right to a fair hearing. I am satisfied, however, that the fair hearing right is not limited, because clause 66 includes written notice requirements of the pending imposition of the specific condition, and allows for an ART provider to make written submissions in response, which must then be taken into consideration by the Secretary. The ART provider would then have a right of judicial review of the decision under administrative law. Finally, an ART provider is a regulated role attracting special responsibilities and duties, including to comply with conditions of registration imposed by the Secretary, to which a person voluntarily assumes when engaging in registration under the scheme.

I am therefore of the view that clause 66 and the imposition of specific conditions on ART providers’ registration, is compatible with the right to a fair hearing.

Right to be presumed innocent

Section 25(1) of the Charter provides that a person charged with a criminal offence has the right to be presumed innocent until proved guilty according to law. The right is relevant where a statutory provision shifts the burden of proof onto an accused in a criminal proceeding, so that the accused is required to prove matters to establish, or raise evidence to suggest, that they are not guilty of an offence.

Offences to contravene improvement, prohibition or information or document production notice, and to provide false and misleading information

As outlined above, the full regulatory toolkit clauses and clauses 104 and 108 of the Bill, contain offences relating to contravention of an improvement, prohibition or information or document production notice without reasonable excuse. These clauses also provide for the offence of providing false or misleading information in responding to an information or document production notice, with the provisions creating an exception to the application of the offence if the person believed on reasonable grounds that the information or document was true or not misleading.

By creating a ‘reasonable excuse’ or ‘reasonable grounds for belief’ exception, these offences place an evidential burden on the accused, in that they require the accused to raise evidence of a reasonable excuse or belief. However, in doing so, this offence does not transfer the legal burden of proof. Once the accused has pointed to evidence of a reasonable excuse or belief, which will ordinarily be peculiarly within their knowledge, the burden shifts back to the prosecution to prove the essential elements of the offence. I do not consider that an evidential onus of this kind limits the right to be presumed innocent.

Offence to certify a false or misleading matter or to contravene a general or specific condition of registration ‍– ART Act

Clause 6 of the Bill inserts new s 37A into the ART Act, and provides that in certifying certain matters in relation to the movement of donor gametes or donor-formed embryos into or out of Victoria, it is an offence to certify a false or misleading matter. New s 37A provides a defence if the person believed on reasonable grounds that the matter was true or not misleading.

Clause 66 of the Bill creates a new s 75D in the ART Act, which provides that it is an offence for an ART provider to contravene a general or specific condition of their registration without reasonable excuse.

As discussed above, the right to the presumption of innocence would not be limited by a defence of reasonable excuse or ‘belief on reasonable grounds’ because once an accused provides evidence of this excuse or belief, the prosecution must prove the relevant elements of the offence, such that the legal burden of proof remains always with the prosecution.

I am therefore of the view that clauses 6 and 66 of the Bill are compatible with the presumption of innocence.

Right against self-incrimination

Section 25(2)(k) of the Charter provides that a person charged with a criminal offence is entitled not to be compelled to testify against themselves or to confess guilt. This right is at least as broad as the common law privilege against self-incrimination. It applies to protect a charged person against the admission in subsequent criminal proceedings of incriminatory material obtained under compulsion, regardless of whether the information was obtained prior to or subsequent to the charge being laid.

Information or document production notices

As discussed above, the full regulatory toolkit clauses and clauses 104 and 108 of the Bill, provide for the compulsory production of information and documents via information or document production notices issued by the Health Regulator. It is an offence to contravene an information or document production notice without reasonable excuse. The compulsory production of documents or information may interfere with the right against self-incrimination, as a person may be forced to provide information or documents that might contain incriminating material.

The information or document production notice offence provisions provide that a person may refuse or fail to provide any information specified in the notice if to do so would tend to incriminate them. There is no such protection from self-incrimination in respect of document production notices – the Bill expressly excludes the protection against self-incrimination as a reason not to produce a document. However, the full regulatory toolkit clauses and clauses 104 and 108 of the Bill do provide further safeguards, in that any document produced by a natural person under an information or document production notice that might tend to incriminate the person is not admissible in a criminal proceeding against the person, unless they are required by law to keep the document, or the proceeding relates to false or misleading information included in the document. The Bill also includes a right for VCAT to review the decision to issue the information or document production notice.

At common law, the protection accorded to pre-existing documents is considerably weaker than that accorded to oral testimony or to documents that are brought into existence to comply with a request for information. The compulsion to produce pre-existing documents that speak for themselves is in strong contrast to testimonial oral or written evidence that is brought into existence as a direct response to questions. Accordingly, any protection afforded to documentary material by the privilege is limited in scope and not as fundamental to the nature of the right as the protection against the requirement that verbal answers be provided. This is particularly the case in relation to a regulatory regime where a person has assumed a role attracting special responsibilities and duties, including record keeping requirements for the purpose of demonstrating compliance with regulation.

In view of the protection against self-incrimination offered by the Bill in respect of the production of information, the limited protection afforded at common law to pre-existing documents such as those that might be subject to an information or document production notice in the Bill, and the safeguards referenced above, including the oversight of the powers by VCAT, I am of the view that the right against self-incrimination is not limited by the information or document production notice powers provided by the Bill.

Right not to be tried or punished more than once

Section 26 of the Charter provides that a person must not be tried or punished more than once for an offence in respect of which they have already been finally convicted or acquitted in accordance with law. This right reflects the principle of double jeopardy. However the principle only applies in respect of criminal offences – it will not prevent civil proceedings being brought in respect of a person’s conduct which has previously been the subject of criminal proceedings, or vice versa.

Suspension of ART providers

Clause 67 of the Bill amends s 76 of the ART Act to transfer the power to suspend the registration of ART providers, for a contravention of a condition of their registration, from VARTA to the Secretary. Additionally, clause 67 inserts a new s 76(1)(ab) into the ART Act to empower the Secretary to suspend the registration of an ART provider if the Secretary reasonably believes that the provider has contravened a provision of the ART Act or the regulations. Clause 68 then amends s 77 of the ART Act to empower the Secretary, rather than VARTA, to immediately suspend a provider’s registration if there is an overriding public interest.

The suspension of an ART provider’s registration for contravention of a condition of their registration or of the ART Act or regulations is relevant to this right, if the provider is also prosecuted for an offence under the ART Act or any other legislation for the same conduct. However, I am of the view that the right not to be tried or punished more than once is not limited, because sanctions imposed by professional disciplinary bodies or regulators do not usually constitute a form of ‘punishment’ for the purposes of this right. The suspension of ART providers’ registration has a preventative rather than a punitive purpose – to protect users of assisted reproductive treatment – and is not a criminal sanction imposing personal liability.

Should this right in fact be limited, I am of the view that any limitation is justified under s 7(2) of the Charter, in that the suspension of registration is reasonable and proportionate to the legitimate aim of protecting and promoting the quality and safety of assisted reproductive treatment in Victoria.

The Hon. Mary-Anne Thomas MP

Minister for Health

Second reading

Mary-Anne THOMAS (Macedon – Leader of the House, Minister for Health, Minister for Health Infrastructure, Minister for Ambulance Services) (10:55): I move:

That this bill be now read a second time.

I ask that my second-reading speech be incorporated into Hansard.

Incorporated speech as follows:

Introduction

The Bill will make amendments to regulatory frameworks in seven Acts to modernise, streamline and strengthen compliance and enforcement powers to support a graduated, proportionate and risk-based approach to regulation by the Department of Health’s Health Regulator, and prevent or minimise the risk of harm to the health or safety of Victorians.

The Bill will also amend the Assisted Reproductive Treatment Act 2008, to improve regulation of assisted reproductive treatment by transferring the regulatory function to the Department of Health and strengthening compliance and enforcement powers. It will also transfer management of the donor conception registers to a new Donor Conception Registrar employed in the Department of Health. As a result of these reforms the Victorian Assisted Reproductive Treatment Authority (commonly known as VARTA) will cease to be established as a statutory authority under the Assisted Reproductive Treatment Act.

Improved compliance and enforcement tools for health regulation

Health regulation plays a key role in minimising or preventing risk of harm to the health or safety of Victorians and contributes to the vision of a Victoria free of the avoidable burden of disease and injury, so that all Victorians can enjoy the highest attainable standards of health, wellbeing and participation at every age.

The Department of Health has a diverse range of regulatory responsibilities including in relation to child safety, communicable disease, medicines and poisons, legionella risk management, pest control, radiation safety, food safety, private hospitals and day procedure centres, non-emergency patient transport and first aid service providers, tobacco and e-cigarettes, and safe drinking water. The Bill also proposes to transfer regulation of assisted reproductive treatment from VARTA to the Department.

Most of the Department’s regulatory functions are now consolidated in the Health Regulator – a branch of the Department established in early 2024 to consolidate regulatory functions and enable the Department to adopt a more consistent, risk-based regulatory approach.

To perform regulatory functions effectively, regulators should be equipped with a best-practice regulatory toolkit that provides compliance and enforcement powers to enable them to take a risk-based, effective, graduated and proportionate approach to compliance and enforcement. Some health regulation schemes have not kept pace with modern best-practice regulatory design and do not include common mid-range compliance and enforcement powers, limiting the ability of the regulator to take graduated, risk-based and proportionate regulatory action to prevent harm. This is why this Bill modernises compliance and enforcement powers across a number of health regulation schemes.

The Bill improves the compliance and enforcement powers in the Assisted Reproductive Treatment Act, the Drugs, Poisons and Controlled Substances Act 1981, the Health Services Act 1988, the Non-Emergency Patient Transport and First Aid Services Act 2003, the Public Health and Wellbeing Act 2008, the Radiation Act 2005 and the Safe Drinking Water Act 2003.

The Bill ensures that these Acts include powers for the regulator to issue improvement or prohibition notices, to issue an information or document production notice, to issue infringement notices for prescribed offences, and to accept an enforceable undertaking. The amendments in the Bill and the addition of these powers will enable the Health Regulator to choose the right tool at the right time to respond to non-compliance proactively as well as reactively, and to prevent or minimise the risk of harm to health or safety.

Regulation of assisted reproductive treatment

The Bill will amend the Assisted Reproductive Treatment Act to transfer regulatory functions under the Act from VARTA to the Secretary, Department of Health and make other reforms to improve regulation of the sector.

Victoria has long been a leader in the provision and regulation of assisted reproductive treatment. The first Australian IVF baby was born in Victoria in 1980, and Victoria was the first jurisdiction in the country to provide legislative safeguards for individuals undertaking assisted reproductive treatment through the Infertility (Medical Procedures) Act 1984. Victoria was also the first Australian jurisdiction to recognise the needs of people conceived through donor treatment procedures to have access to information about their genetic heritage.

Although assisted reproductive treatment has become an increasingly common way for Victorians to start or grow their families, specific regulation of this sector – including donor conception treatment – remains important to provide safeguards for the children who may be born as a result of treatment, donors, surrogates, and those undertaking treatment. It is critical that we have a modern, fit-for-purpose regulator with the expertise and tools they need to protect and support Victorians.

VARTA currently regulates assisted reproductive treatment in Victoria. To improve the regulation of the sector, including to address certain recommendations in the Final Report of the Review of Assisted Reproductive Treatment undertaken by Michael Gorton AM (the Gorton review), the amendments will make changes to the functions currently performed by VARTA under the Assisted Reproductive Treatment Act. The regulation of assisted reproductive treatment will be transferred to the Secretary, Department of Health. The reforms will also introduce new compliance and enforcement powers to the legislation and new offences, to align with other health regulatory schemes and address issues specific to the sector.

The management of the donor conception registers will be transferred to a new Donor Conception Registrar, which will be located within the Department of Health, administratively separate from the regulatory functions. Counselling before information being accessed from the registers or a contact preference being lodged will transition from mandatory to voluntary, respecting the rights of individuals to make an informed choice about their needs. Counselling will remain mandatory before consenting to treatment or consenting to be a donor. The Assisted Reproductive Treatment Act will continue to require that people are provided with the information they are entitled to from the donor conception registers in a supportive way and that they have access to resources to help them make informed decisions. As part of this, the amendments in the Bill introduce requirements for the Donor Conception Registrar to provide information to people who are making applications to the registers, or whose information might be released from the registers, to assist them to navigate the issues that might arise.

We know that while donor conception is an increasingly common method of family formation, it can present unique challenges and complexities for those involved. That is why the proposed reforms include plans to deliver funding for an appropriate organisation, with suitably qualified and experienced counsellors, to deliver quality, culturally safe counselling, for those involved in accessing the registers and who wish to access counselling.

VARTA’s public education, research promotion and community consultation functions will be removed from the Assisted Reproductive Treatment Act. The Victorian Government recognises that resources developed and published by VARTA over many years are highly valued, and is committed to continuing to make those available through non-legislated arrangements.

The Victorian Government is committed to upholding the guiding principles in the Assisted Reproductive Treatment Act, including that the welfare and interests of persons born or to be born as a result of treatment procedures are paramount. These amendments are intended to allow the protections in the legislation to operate most effectively as safeguards for Victorians – including persons born as a result of treatment procedures, those seeking and receiving ART treatment, and others involved in donor conception.

The amendments are also intended to reflect changes since VARTA was established, that include significant clinical and social advances in relation to fertility treatment. The specialised aspects of assisted reproductive treatment as a health service will continue to be recognised. It is also acknowledged that assisted reproductive treatment raises issues that are not common to other health services – for those accessing treatment, for people conceived through donor treatment procedures, and for donors and surrogates – and that these issues may require specific legal protections. However, the changes recognise that the most effective avenue of support for those who are involved or impacted may not require legislated functions delivered by a regulatory agency.

In line with a recommendation of the Gorton Review, the amendments will reduce unnecessary regulatory barriers for movement of donor gametes or embryos formed from them into or out of Victoria while maintaining effective safeguards and existing requirements, including those relating to counselling, consent and provision of information for the registers. The requirement to have pre-approval from the regulator before moving donor eggs or sperm (or embryos formed from them) into or out of Victoria, will be replaced with a requirement to certify specific criteria have been met, providing additional clarity and reducing delays.

A Donor Conception Advisory Group, made up of experts and lived experience advocates will be established to assist with the implementation of the reforms and provide ongoing advice and expertise in relation to donor conception.

Other amendments

The Bill makes minor or miscellaneous amendments to a number of Acts. The Bill amends the Drugs, Poisons and Controlled Substances Act to enable the Minister to amend the Victorian Poisons Code to remove, substitute or incorporate amended provisions from the Poisons Standard relating to the supply or possession of certain scheduled medicines.

The Bill will rectify an error in the general immunity provision in the Public Health and Wellbeing Act 2008 to make it consistent with the Government policy and guidelines: indemnities and immunities.

The Bill removes the definition of Epworth Hospital from the Epworth Foundation Act 1980 as the definition is not relevant to any substantive provisions in the Act and may unnecessarily create confusion about the current corporate structure of Epworth Healthcare and the Epworth Foundation.

The Bill will amend the definition of water supplier in the Safe Drinking Water Act by substituting “Alpine Resorts Victoria” for “Alpine Resort Management Board” to reflect updates to the Alpine Resorts (Management) Act 1997.

The Bill will make some other minor amendments to reflect machinery of government changes and make statute law amendments.

Conclusion

This Bill will enable the Health Regulator to more effectively minimise risks to the health and safety of Victorians. The amendments to the Assisted Reproductive Treatment Act will improve the regulation of assisted reproductive treatment to better protect Victorians, simplify access to information from the donor conception registers, and reduce unnecessary barriers related to accessing donor gametes.

I commend the Bill to the house.

James NEWBURY (Brighton) (10:55): I move:

That the debate be adjourned.

Motion agreed to and debate adjourned.

Ordered that debate be adjourned for two weeks. Debate adjourned until Wednesday 28 August.