1.1
The Australian Institute of Health and Welfare Amendment (Assisted Reproductive Treatment Statistics) Bill 2019 (bill) was introduced in the Senate by Senator Stirling Griff on 4 July 2019.
1.2
The bill seeks to amend the Australian Institute of Health and Welfare Act 1987 (AIHW Act) to require accredited assisted reproductive technology (ART) centres, also known as fertility or IVF clinics, to provide annual statistical information about their performance to the Australian Institute of Health and Welfare (AIHW) and require the AIHW to publish this information and a list of centres that fail to comply with the requirement.
Background
1.3
Although comprehensive statistics on ART procedures in Australia and New Zealand are collected through the Australian and New Zealand Assisted Reproduction Database (ANZARD) and published each year, comparable statistics at an individual clinic level are not publically available in any Australian state other than Victoria. The Explanatory Memorandum to the bill notes that:
Currently, the only statistics published for each fertility clinic are those which the clinics wish to disclose themselves.
1.4
In his second reading speech, Senator Griff stated that:
[ART] is miraculous, but the process can also be emotional, heartbreaking - and very expensive. Couples desperate for a child will often hand over thousands of dollars for each attempt but, at the moment, they are doing it with very few facts to go on.
Their choice of specialist or clinic might be decided by reputation, GP referral, online reviews or the recommendations of friends. The decision won't be made on objective and transparent information about the clinic's performance because this information is currently hidden from the public. This turns an important life decision into a lottery and needs to change.
1.5
The annual ANZARD reports show a significant difference in the rate of live births at different fertility clinics; for example, in 2017 the rate of live births from IVF cycles varied from 9.3 per cent to 33.2 per cent among fertility clinics in Australia and New Zealand, with a median rate of 20.6 per cent. However, consumers are unable to determine which clinics are the best- and worst-performing from this data alone.
1.6
Concerns have been raised in recent years about the accuracy and quality of ART 'success rate' data shared by individual fertility clinics in their advertising to potential clients. In 2016, the Australian Broadcasting Corporation's 7:30 Report program reported that some fertility clinics were advertising using selective statistics which could mislead consumers to believe their chances of having a baby were higher than reality, or that a particular clinic's services were more likely to result in pregnancy and/or birth than other clinics.
1.7
A 2016 review by the Australian Competition and Consumer Commission found that several major fertility clinics had made false or misleading representations about their success rates on their websites. This review prompted best practice guidelines for advertising ART success rates to be issued by the Fertility Society of Australia's Reproductive Technology Accreditation Committee (RTAC) in 2017.
1.8
In April 2018, the Victorian Government initiated a review of ART treatment and its regulatory framework in the state, the final report of which was released in May 2019. This review also raised concerns about success rates advertised by fertility clinics, but reported that stakeholders had seen significant improvement in the way that success rates are published since the new guidelines were issued by the RTAC in 2017.
1.9
In response to concerns about the quality of data currently available, the bill proposes to introduce new reporting requirements for fertility clinics to ensure that consumers are able to access transparent and consistent success rate data at the clinic level, from a single source, with an aim to:
…provide consumers with information about the performance of each fertility clinic, to allow them to make an informed choice about their prospective treatment facility.
Conduct of the inquiry
1.10
On 25 July 2019, the Senate referred the bill to the committee for inquiry and report by 11 November 2019. On 11 November 2019, the reporting date was extended to 4 December 2019.
Evidence
1.11
The committee received 12 submissions which were published to the committee's website and one confidential submission. The committee held a public hearing in Melbourne on 21 November 2019. Lists of submitters and witnesses are included at Appendices 1 and 2.
1.12
The committee thanks all of those who contributed to the inquiry.
Note on references
1.13
References to the committee Hansard are to the proof transcript. Page numbers may vary between the proof and official Hansard transcript.
Provisions of the bill
1.14
The bill contains one schedule comprising four items.
1.15
Item 1 of the bill proposes amending Section 3 of the AIHW Act to insert definitions for 'assisted reproductive treatment', 'accredited ART centre', and 'chief executive' of an accredited ART centre.
1.16
Item 2 of the bill proposes an amendment to Subsection 5(1) of the AIHW Act. This subsection of the AIHW Act sets out the numerous health-related functions of the AIHW, including but not limited to collecting health-related statistics and information, conducting and promoting research into health services and the health of the population, and publishing reports on this work. The proposed amendment would add a health-related function at paragraph 5(1)(ca) for the AIHW to publish statistical information received from accredited ART centres.
1.17
Item 3 of the bill sets out a new Part IIA for the AIHW Act, which specifies functions for the AIHW in relation to collecting and publishing ART statistics. This part is in two sections:
19A provides that the chief executives of accredited ART centres must give certain statistical information to the AIHW annually, sets out what this statistical information must include, and includes an offence of strict liability with a penalty of 100 penalty units for chief executives who fail to provide this information.
19B sets out provisions for publication of statistical information from ART centres, including requiring that the AIHW publish a list of ART centres that fail to comply with section 19A.
1.18
Item 4 of the bill is an application provision that specifies that the requirements in proposed Section 19A apply from the financial year starting on 1 July 2019.
Financial implications
1.19
The Explanatory Memorandum does not specifically address the financial implications of the proposed amendments, however it does state that:
Medicare provides a substantial rebate for fertility treatments (just under half of the approximate $10,000 cost for a first IVF cycle) and the associated medication is heavily subsidised through the Pharmaceutical Benefits Scheme, so there is also a fiscal benefit to taxpayers in ensuring that infertile consumers can make informed choices about their treatment.
Legislative scrutiny
1.20
The Senate Standing Committee for the Scrutiny of Bills raised concerns about the strict liability offence proposed in the bill for ART centres that fail to provide statistics to the AIHW. These concerns are discussed later in this report.
1.21
The Parliamentary Joint Committee on Human Rights reported that the bill does not raise human rights concerns.
Issues raised by submitters and witnesses
1.22
All submitters and witnesses to the inquiry expressed overall support for the aim of the bill to improve the availability and quality of information about ART treatments and fertility clinic performance for consumers; however views differed on whether the data collection and publication proposed by the bill is the most appropriate way to achieve this aim.
1.23
In particular, submitters and witnesses raised issues relating to:
how ART data is currently collected and published in Australia, including comparisons to similar databases internationally;
initiatives already underway to improve the availability of information for consumers to assist in their decision-making about ART treatments;
potential sensitivities and risks associated with publishing clinic-level ART data; and
whether the AIHW is the appropriate body to collect ART data.
1.24
These views and concerns are addressed below.
Collection and publication of ART data in Australia
1.25
As outlined earlier in this chapter, comprehensive statistics on ART treatments in Australia and New Zealand are currently collected through ANZARD. ANZARD annual reports provide a detailed, de-identified review across a range of different treatments on a whole-of-industry scale, based on data relating to:
patient demographics, including patients' age and causes of infertility;
the numbers of different types of treatments and procedures; and
outcomes, such as numbers of clinical pregnancies, live births, and births at term with normal birthweight.
1.26
ANZARD, which was established in 1983, is coordinated by the National Perinatal Epidemiology and Statistics Unit at the University of New South Wales (NPESU) in partnership with the Fertility Society of Australia. ANZARD collects data from 100 per cent of clinics in Australia, as clinics are required to report their treatment and outcome data in order to be licensed by RTAC to practice ART treatment. ANZARD data is also audited by RTAC.
1.27
The Department of Health (Department) reported that ANZARD is the most complete ART treatment database in the world and plays a significant role in promoting safety and quality in the sector, as well as providing feedback to fertility clinics on their performance to improve practice.
1.28
In addition to ANZARD, two states, Victoria and Western Australia, publish annual ART treatment data:
The Victorian Assisted Reproduction Technology Agency (VARTA) publishes annual treatment outcome data for all fertility clinics, at a clinic level, in that state as part of its annual reports. This data is displayed in a format which can be used to make direct comparison between clinics.
In Western Australia, the Reproductive Technology Council publishes some ART treatment data for that state in its annual reports. However this data is limited to the number of ART treatments undertaken in the state and does not include any outcomes of success or clinic-level information.
1.29
Some submitters noted that ANZARD does not currently provide data at a clinic level in its reports. The Public Health Association of Australia (PHAA) submitted that data available from ANZARD:
…is only high-level outcome data, and is not of specific use to guide client decisions on a case-by-case basis.
International ART treatment databases
1.30
The Explanatory Memorandum states that requiring fertility clinics to provide data to the AIHW, as proposed by the bill:
…will provide Australian consumers with the same transparent and consistent information currently provided to consumers in the United States and in the United Kingdom, where national registers already disclose the performance of fertility clinics.
1.31
The Human Fertilisation and Embryology Authority (HFEA) is the regulator of ART treatments in the United Kingdom (UK) and publishes annual trend data in a similar format to that produced by ANZARD in Australia. HFEA hosts a searchable database of individual fertility clinic information, including treatments, inspection rating, patient rating, and whether the clinic's success rate falls within the national average.
1.32
In the United States (US), the Center for Disease Control and Prevention (CDC) is responsible for the collection of ART treatment statistics through the National ART Surveillance System (NASS). Clinics voluntarily provide their data annually either directly to NASS or through the US Society for Assisted Reproductive Technology (SART). NASS data can be accessed in a national summary, much like ANZARD data, as well as in a searchable database of individual clinics, listed by state. The CDC also uses NASS data to publish standardised Fertility Clinic Tables, which can be used for direct comparison between clinics.
1.33
The Explanatory Memorandum to the bill states that the NASS model provides 'the type of information Australians using fertility services should be able to access' and that the bill will allow this to happen.
1.34
While some submitters agree that both the HFEA and NASS databases provide useful information which enables consumers to make informed decisions about fertility clinics, submitters also noted that those databases are difficult for consumers to accurately interpret. Dr Peter Illingworth from the Fertility Society of Australia (FSA) told the committee:
One of the challenges…is that they're very hard to understand for the consumer. And, in looking at the models from SART in the US and the HFEA in the UK, both of those models communicate an element of the statistical variation inherent in those sorts of data but also present a wide range of numbers, which are very hard for consumers to follow.
1.35
Other submitters raised concerns about the quality of the information available in international databases. In particular, some submitters noted a low level of reporting compliance in the US: in the last reporting period, only 463 of the 502 US fertility clinics submitted data to NASS. The submission from the Australian and New Zealand Specialists in Reproductive Endocrinology and Infertility (ANZSREI) referenced a study which found that some fertility clinics in the US underreport the number of IVF cycles to NASS in such a way as to make it difficult to assess the clinic's actual success rates.
1.36
Some submitters also raised concerns about the use of unsafe ART practices to boost clinic performance in other countries, with NPESU indicating that public reporting of success rates in the US and UK had encouraged 'aggressive [multiple] embryo transfer practices at the expense of the safety of women and their babies' in an attempt to achieve high birth rates per number of cycles. Evidence from the Department observed that the ART multiple birth rate in the US in 2015 was 35.3 per cent, compared to only 4.4 per cent in Australia and New Zealand. NPESU submitted that multiple gestation pregnancy due to the transfer of more than one embryo poses the greatest risk to both mothers and babies from ART treatment.
1.37
In response to these concerns, ANZSREI submitted that:
It would seem…prudent to learn from the experience gained in the past in international settings before mandating reporting of success rates from IVF clinics in Australia. This will take careful consideration and the goal should be to ensure that Australia leads the world rather than repeats the errors of Britain and USA.
Recent initiatives to improve the information available to consumers
1.38
The committee received evidence that a process is underway to begin clinic-level data reporting from ANZARD within the next year. The Department submitted that this public reporting website would:
…be informed by consultation and testing with clinicians and consumers on meaningful, consumer friendly content. The website would be designed to encourage joint patient-clinician decision making and minimise the potential for adverse impacts on clinical practice…
1.39
The FSA noted that ANZARD was developed as a tool for clinicians and explained that the public reporting website would ensure that ANZARD data is presented in a way that 'is both sophisticated and clear to consumers, in consumer friendly language'. Mr Rick Forbes from the FSA described to the committee the importance of clinical information being presented in the correct way for consumers:
This is a translation of [ANZARD] information or a drawing from it to make a consumer database. That must be done very carefully because one of the guiding rules in medicine is, 'First, do no harm,' and I would parallel that by saying: 'First, don't give bad information. Don't give patients bad information just because you've got to give them information. Make sure that's high-quality information and it's information they're capable of understanding and using to make informed decisions about their clinical progress'.
1.40
The Department submitted that using ANZARD's data on prognostic factors to inform consumer information would 'help reduce the potential adverse impact of a narrow focus on pregnancy and live birth rates, currently included in the [bill]'.
1.41
In addition to this public reporting website, submitters and witnesses noted NPESU's development of an 'Online IVF Predictor Tool' to sit alongside the public reporting website. This online tool will use ANZARD data to provide consumers with a personalised prediction of their chance of having a live birth through IVF based on their personal prognostic indicators, also due for release in the coming year.
1.42
In light of these ANZARD developments, some submitters and witnesses questioned whether the bill is a necessary step to achieve improved customer information and clinic-level reporting of ART statistics in Australia.
Concerns about publishing clinic-level data
1.43
While evidence to the committee generally supported the public availability of ART data, a number of submitters and witnesses noted the need for care in the publication of this type of data.
1.44
The Department submitted that public reporting of clinic-level health care outcomes, not just ART outcomes, is a 'sensitive issue' in Australia. The Department noted that while such reporting can have positive impacts in terms of transparency and better informed consumers, there is also potential for unintended consequences. The Department's 2019 consultation on the draft National Clinical Quality Registry Strategy identified concerns about a focus on 'league tables' and 'naming and shaming' clinicians rather than on quality improvement.
1.45
The FSA told the committee that league tables are:
…not a feature of Australian medicine anywhere. There are no league tables on surgeons, hospitals or operations—it just simply doesn't exist in Australia. The reason it doesn't exist is that many people feel that league tables are injurious to patients, in that they disincentivise treatments of the difficult patients.
1.46
Submitters and witnesses also raised a number of specific concerns about the impact of publication of clinic-level ART treatment data on an individual clinic's practice in Australia, advising that clinics wishing to present a high success rate could be motivated to 'game the system' by:
engaging in unsafe medical practices which increase risk to patients, such as multiple embryo transfer, as seen in the US and UK;
encouraging patients with good prognoses to undergo unnecessary ART, rather than less invasive interventions;
refusing to treat patients who have poorer prognoses of success due to age, period of infertility or previous failed attempts;
resisting using new technologies, which may have lower success during early adoption; and
creating 'parallel' clinics–where patients with good prognoses are sent to the clinic with high pregnancy rates and those with poor prognoses to the clinic with low pregnancy rates–and therefore increasing the cost of conducting business.
1.47
The National Health and Medical Research Council (NHMRC) submitted that the publication of statistics on the use of ART has the potential to empower consumers to participate actively in decision making; assist clinics and clinicians to support informed decision making, and assist with the management of expectations and support effective and efficient practices.
1.48
The NHMRC noted that:
…the intention of the Bill to take account of patient demographics should help to alleviate the potential for inequity of access, by enabling clinics to specialise in these complex cases, without fear of being compared to another clinic which does not provide such services.
1.49
Dr Richard Henshaw, an IVF specialist, submitted that, while 'attempts have been made by less scrupulous overseas operators to "game" the system by excluding poor prognosis patients from treatment', this fraud has not been observed in Victoria, where clinic-level outcomes are already being reported by VARTA. Dr Ronald Carson, another IVF specialist, also noted that where it appeared clinics in Victoria had attempted to use comparative data published by VARTA for commercial advantage, this had been prevented through the use of 'cease and desist' letters. He stated that:
There seems to be a fairly reasonable understanding in Victoria that you don't use the comparative data in your advertising. You can refer patients or prospective patients to the VARTA website.
1.50
Associate Professor Georgina Chambers, Director of NPESU, also described the measures being undertaken by ANZARD to reduce the possibility of clinics gaming the system through its own clinic-level public reporting project, including:
measuring success for fresh and frozen IVF cycles alike, which will allow clinicians and patients to choose the right treatment for the individual, rather than encouraging particular clinical practices in order to be compared with other clinics;
measuring pregnancy and live birth rates by embryo transferred rather than by IVF cycle, which would discourage multiple embryo transfers being used to boost these rates; and
developing a 'standardised patient' model for reporting success rates for first-time IVF clients to address issues around clinics specialising in more complex cases.
1.51
Dr Claire Boothroyd, President of ANZSREI, described that while work could be done to reduce gaming of data, there may still be ethical dilemmas, particularly for smaller clinics:
You're putting clinicians under enormous ethical tensions by making the commercial viability of their unit dependent on a single number…When this proposal came out in July, I remember seeing a patient who had had seven cycles in another clinic, with a low egg reserve. I knew as a clinician she had a very poor chance. I said to her, 'Do you know what? This is what we'll do'…but in a year's time, I'd have to say 'I'll decline to treat you, because you will reduce my success rates, and I can't afford to do that because I won't have a clinic'.
Presenting data in a form that consumers can access and interpret
1.52
As noted above, the aim of the bill is to provide consumers with information to allow them to make an informed choice in identifying an ART clinic. Submitters agreed that it is important for consumers to have access to accurate, consistent and comprehensive information to support their decision making. The PHAA noted that the high-level outcome data currently available via ANZARD 'is not of specific use to guide client decisions on a case-by-case basis'.
1.53
Submitters also raised concerns about the complexity of analysing clinic-level data and whether this would present challenges to consumers, rather than assisting them to understand their likelihood of success. NPESU submitted that it is important that published success rates are easily understood and relevant to individuals. NPESU noted:
As is the case in other countries around the world, it is important that those with the expertise in ART registry data and analysis undertake the reporting of clinic-specific success rates, to minimise the risk of providing misleading information to women and couples.
1.54
Access Australia noted the importance of published data being presented using consumer friendly language together with comprehensive information to guide consumers in interpreting the data.
1.55
The FSA explained how it is seeking to improve on data bases such as the SART in the US and the HFEA in the UK by focussing on how to communicate data in a way that consumers can interpret:
What we want to do is to do the same thing but in a much more consumer friendly way to illustrate variability through properly designed tables and properly designed figures in four or five different parameters so that consumers can see the way that different types of women will come through and have a success rate from IVF.
1.56
Access Australia stressed the importance of assisting consumers to manage their expectations and cautioned against an undue reliance on success rates alone. Access Australia noted the importance of consumers also having access to a range of information about the type and quality of service offered both in terms of clinical and laboratory expertise and the availability of counselling and support after treatment.
Presenting 'results' creates the opportunity to misinform and mislead vulnerable patients.
In contrast, presenting the service provided can help patients to understand how the clinic will support them as they undergo treatment, with realistic expectations about reaching their desired destination. It is important for patients to be confident that the clinic will endeavour to meet their specific needs,…
The proposed role for AIHW in ART data collection and publication
1.57
Submitters and witnesses raised a range of concerns regarding the role for AIHW proposed in the bill. These concerns are detailed below.
Duplication of existing schemes
1.58
Submitters noted that introducing an additional ART reporting mechanism through the AIHW would duplicate statistics already being provided by fertility clinics to ANZARD and state-based reporting schemes. Submitters noted that there are cost implications associated with this for government, the ART sector and consumers.
1.59
The Department submitted that the bill, as currently proposed, does not contain detailed information about the data set to be collected by AIHW and that:
…there is potential for…significant duplication, inefficiency and errors related to the collection of data already collected, analysed and reported by ANZARD, in a comprehensive and meaningful manner.
1.60
Dr Boothroyd advised that ANZSREI considers that separate reporting to the AIHW would be counterproductive and described the onerous nature of reporting to different entities:
I think one of the recommendations of the [ANZARD] review committee was that duplicate reporting to different jurisdictions should either be harmonised or removed. It's very onerous on the clinics in Victoria and Western Australia, for instance to report different metrics to different jurisdictions, and that increases the costs. I think that's something we really need to be moving away from.
1.61
Associate Professor Chambers described that duplicating data through AIHW may hinder ANZARD's role in the provision of clinical feedback to underperforming fertility clinics. Associate Professor Chambers noted that ANZARD data is used to identify underperforming clinics and report this to RTAC. Under the current system, clinics that are underperforming are able to seek more detailed data from ANZARD to enable them to identify the source of problems:
We produce more data for them to pinpoint where they have got problems. It might be their frozen embryo transfer rates, for example. If their results are also being presented on an AIHW website, the clinics are going to come to us. And I will say that I can't synchronise what the AIHW are doing with their clinic success rates—whereas I can if it is in house...
1.62
One avenue for addressing concerns about duplication would be for AIHW to draw on and publish data directly from ANZARD. However, Professor Chambers explained that there are complexities with multiple agencies drawing on data from ANZARD, noting the fact that ANSARD links to multiple data bases and the importance of data sets aligning.
Defining the proposed data set
1.63
Some submitters questioned the appropriateness of the definitions of ART treatments and the data set proposed in Items 1 and 3 of the bill.
1.64
Dr Ronald Carson observed that the bill contains 'an overly simplistic view of the determinants of success in assisted reproduction and [a] very dated definition of assisted reproduction'. ANZSREI shared this view, submitting that the bill 'has defined parameters of success which are summarised as a crude statistic which is not applicable to an individual couple'.
1.65
The Australian Healthcare and Hospitals Association (AHHA) noted that the bill provides that other statistical information may be specified in regulations, and recommended expanding the data set on outcomes to include pregnancies, live births, perinatal outcomes of babies and ART complications and that this information be disaggregated and reported by ART type and age. The AHHA also recommended that statistical information on fees charged by ART type also be included.
1.66
Submitters also noted the need for care in developing a process for public reporting of ART data. The Department noted that the bill does not provide detailed information on the process or the complete data set to be collected and reported. The Department emphasised the need for stakeholder consultation in the development of a data collection process and data set to work through potential sensitivities and adverse impacts. ANZSREI also noted the need for further consultation of the measures proposed in the bill.
1.67
AIHW considered that the data set and the publication of that data as proposed in the bill would need some clarification and refinement, and noted that this bill is unusual in so far as it seeks to prescribe a data set in the AIHW Act. Dr Webster noted that the bill dictates exactly the nature of the information that the AIHW would be asked to publish and that, to his knowledge, this was the first time that a data set has been prescribed in this way. The PHAA also noted that it is unusual to specify a particular domain of data collection in the charter legislation of the AIHW, but observed that the ART sector is an unusual sector.
1.68
Associate Professor Chambers described that legislation needs to be sufficiently flexible to enable data sets to be improved and adapted to take account of innovations both in methods of ART and in data management and dissemination. The AIHW acknowledged the dynamic nature of datasets and dataset specifications, noting that this 'is always a live issue' requiring work with stakeholders and the sector around the evolution of national minimum data sets to reflect changes in clinical practice and technology over time'.
Strict liability provisions
1.69
As noted earlier in this report, the Senate Standing Committee for the Scrutiny of Bills (Scrutiny committee) raised concerns about the strict liability offence proposed in the bill for ART centres that fail to provide statistics to the AIHW. The Scrutiny committee noted in its report that the Explanatory Memorandum fails to include a justification as to why the offence is subject to strict liability or an outline of whether the approach is consistent with the Guide to Framing Commonwealth Offences.
1.70
The Scrutiny committee further questioned the fine of 100 penalty units proposed by the bill, noting that the Guide to Framing Commonwealth Offences states that the application of strict liability is only considered appropriate where the offence is only punishable by a fine of up to 60 penalty units for an individual.
1.71
In evidence to the committee, Dr Webster noted that this provision would introduce a new compliance role for the AIHW and described the potential for unintended consequences in terms of the AIHW's ability to administer those arrangements.
Is ANZARD a more appropriate data custodian?
1.72
As noted above, several submitters and witnesses questioned the need for the bill and expressed the view that ANZARD is better placed than the AIHW to continue to have responsibility for the custody of ART data at a clinic level, due to its long-standing role in ART data collection and publishing in Australia.
1.73
The FSA expressed concern that the manner in which AIHW data is currently published would not support the aims of the bill to enable patients 'to understand the data in a clinical context and them make the informed clinical decision'. Mr Rick Forbes explained that the more dynamic capacity of the ANZARD data base, together with the predictor tool currently under development, would provide a better base for patients to make informed decisions.
1.74
The Department noted that ANZARD is the most complete IVF database in the world and is well placed to deliver public reporting on accredited ART Unit performance:
ANZARD has already developed a proposal to build a public reporting website and an online predictor tool, based on data it already collects, analyses and feeds back to Accredited ART Units. It has identified and addressed the issues and risks involved and has the capacity to provide comprehensive, meaningful, consumer friendly public reporting, with the support of the Fertility Society of Australia.
1.75
Associate Professor Chambers emphasised the independent nature of ANZARD:
ANZARD is managed at an independent academic institution. It is not purely an IVF [Fertility Society of Australia] database. It was set up as a collaborative effort under the direction of the NHMRC for the NPESU to set it up in conjunction with the [Fertility Society of Australia]. Having an independent academic group undertake the reporting and statistics gives us a great deal of separation between the clinics and government, so I think it is actually a good model.
1.76
Surrogacy Australia noted the importance of implementing an auditing process to ensure the accuracy of data collected:
As the National Perinatal Epidemiology & Statistical Unit at the University of NSW is already collecting this data on an annual basis, it may make more sense for this unit to be tasked with this more granular reporting, as long as independence from the IVF sector can be assured.
1.77
NPESU explained that ANZARD already achieves 100 per cent reporting compliance because reporting of treatment and outcome data to ANZARD is a licensing requirement under the RTAC audited Code of Practice. NPESU submitted that the bill's objective to provide clinic-specific reporting could be addressed by editing the Code of Practice to state that the data collected will be used for public reporting. Associate Professor Chambers explained:
So I think the code of practice should be changed to say exactly what it says now: that you need to provide the ANZARD data dictionary—it is mandatory that you provide the data—and that data will be used for the public reporting of clinic success rates; and, if they don't comply, they don't get their MBS and PBS subsidies and they are not licensed. I think that's all that needs to occur. It has worked so far.
Committee view
1.78
The Australian Institute of Health and Welfare Amendment (Assisted Reproductive Treatment Statistics) Bill 2019 aims to ensure that Australian consumers have access to the information they require to choose an ART clinic that will meet their specific needs. It seeks to respond to concerns raised regarding the transparency and veracity of publicly available information about the performance of ART clinics.
1.79
Evidence to this inquiry has indicated wide in principle support for the broad objective of the bill. At the same time, it has underscored the importance of providing independent, consistent and accurate data to support individual consumers to make an informed choice regarding their ART treatment. The committee notes that this goes to the heart of patient-centred care and that the level of information currently available to consumers falls well short of achieving this objective.
1.80
The only data available at a clinic level is the data that individual clinics choose to disclose. Further, while ANZARD collects and maintains a robust and comprehensive set of data, this data is not currently presented in a way that can be readily understood by clinicians, let alone consumers, and not at the level of individual clinics.
1.81
The committee notes the view put by the majority of submitters and witnesses that in its current form the bill may result in a range of unintended consequences. Options to address some of these were canvassed during the inquiry. In particular, the committee notes the evidence received regarding the complexity of ART data and shares the concern of submitters and witnesses that care and expertise is required to ensure that data is presented accurately and clearly. The committee recognises the need to minimise the risk of providing misleading information.
1.82
Equally importantly, the committee considers that the development of reporting practices must be preceded by careful analysis to guard against unintended consequences, such as providing an incentive to use unsafe practices, a disincentive to treat patients with poorer prognoses or increasing costs to ART Units, consumers and government.
1.83
The committee recognises that NPESU, with the support of the Australian Government and the FSA, is currently developing a public reporting website and an on-line predictor tool which will draw on the data already collected through ANZARD.
1.84
The committee considers that before legislation of this type can be considered by the parliament, further analysis and consultation is required to address the concerns raised during this inquiry and to clarify how the reporting and compliance initiatives contemplated in this bill will operate alongside ANZARD, the RTAC audited Code of Practice and the proposed website and predictor tool.
1.85
The committee recommends that the bill not proceed in its current form.
Senator Wendy Askew
Chair