BILLS DIGEST NO. 14, 2016–17                       22 September 2016

National Cancer Screening Register Bill 2016 [and] National Cancer Screening Register (Consequential and Transitional Provisions) Bill 2016

Amanda Biggs and Alex Grove
Social Policy Section

Mary Anne Neilsen
Law and Bills Digest Section

Date introduced: 31 August 2016

House:  House of Representatives

Portfolio: Health

Commencement: All clauses in the National Cancer Screening Register Bill 2016 (the NCSR Bill), except for clause 13, commence on the day after Royal Assent; clause 13 commences on 1 May 2017. The substantive provisions of the National Cancer Screening Register (Consequential and Transitional Provisions) Bill 2016 commence at the same time as the NCSR Bill.

Links: The links to the Bills, their Explanatory Memoranda and second reading speeches can be found on the home pages for the  National Cancer Screening Register Bill 2016 and the National Cancer Screening Register (Consequential and Transitional Provisions) Bill 2016 or through the Australian Parliament website.

When Bills have been passed and have received Royal Assent, they become Acts, which can be found at the Federal Register of Legislation website.

All hyperlinks in this Bills Digest are correct as at September 2016.

Purpose of the Bills

The purpose of the National Cancer Screening Register Bill 2016 (NCSR Bill) is to establish and provide the legal framework for the operation of a national cancer screening register of information associated with bowel cancer and cervical cancer.

The purpose of the National Cancer Screening Register (Consequential and Transitional Provisions) Bill 2016 (Consequential Bill) is to deal with consequential and transitional matters.

Both Bills were first introduced during the 44th Parliament on 5 May 2016, but lapsed on dissolution of the Parliament.[1]

Structure of the Bills

This NCSR Bill is divided into four parts:

•       Part 1 deals with preliminary matters including relevant definitions

•       Part 2 establishes the new National Cancer Screening Register (the Register) and amongst other things sets out the content and purpose of the Register

•       Part 3 deals with the use and disclosure of information in the Register

•       Part 4 deals with other matters including civil penalties, approved forms, agreements and delegations.

The Consequential Bill has one schedule with two parts. Part 1 amends three related Acts; Part 2 proposes application and transitional provisions relating to the establishment of the Register.

Background

Basis of policy

Intent

The Register will support the operation and planned expansion of two cancer screening programs: the National Cervical Screening Program (NCSP) and the National Bowel Cancer Screening Program (NBCSP). Screening involves testing people with no obvious signs of disease. The aim of screening is to detect cancer early so that treatment can commence before the disease progresses to a more serious and more difficult to treat stage.

Broadly, the Bills establish the Register and authorise it to collect, use, transfer and disclose information relevant to the two programs. Both programs are being expanded in line with recent clinical advice. The government anticipates that the expansion of the NCSP will prevent an additional 140 cervical cancers each year, while the expansion of the NBSCP may prevent 300–500 deaths per year.[2] In future the Register could be expanded to support other cancer screening programs.

The decision to establish the Register was announced in the 2015–16 budget.[3] A further commitment was made in the 2016–17 budget, which allocated $178.3 million to develop the Register.[4] An open tender process was conducted which resulted in Telstra Health being awarded the contract to operate the new Register.[5] The announcement of the contract occurred during the Caretaker period.[6]

Burden of cancer

Bowel cancer (also known as colorectal cancer) is very common in Australia. It was the third most commonly diagnosed cancer in Australia in 2012 (14,958 new cases), and is expected to be the second most commonly diagnosed cancer in 2016 (17,520 new cases expected). Bowel cancer is more common in men than women, and the incidence generally increases with age. Bowel cancer was the second most common cause of death from cancer in 2013 (4,162 deaths), and is expected to be the second most common again in 2016 (4,094 deaths expected).[7]

Cervical cancer is much less common than bowel cancer in Australia. Cervical cancer was the 15th most commonly diagnosed cancer in Australian females in 2012 (869 new cases), and is expected to be 15th again in 2016 (903 new cases expected). There were 224 deaths from cervical cancer in 2013, and it is estimated that this will increase to 250 deaths in 2016.[8]

Role of registers in screening

The use of registers in organised national cancer screening programs is a feature in many countries. A review of organised screening programs since 1970 found European guidelines on screening frequently featured registers as a key component of their programs.[9] Whether a screening program is categorised as organised:

… tends to come down to one key factor: whether or not all eligible women are personally invited to attend screening. This aspect of organisation relies on the existence and availability of a population register to a screening programme.[10]

Other evidence supports the importance of registers in supporting national screening activities. A recent study into the effectiveness of two Danish registers for breast and cervical cancers found the Danish registers proved to be valuable in evaluating the effectiveness of their ongoing cancer screening programs.[11]

The review of organised screening programs noted that privacy issues can determine the feasibility of population-based registers in some screening programs.[12]

National Cervical Screening Program

The National Cervical Screening Program[13] (NCSP) was established following the recommendation of the Cervical Cancer Screening Evaluation Steering Committee, set up by Australian Health Ministers in 1988, to examine the benefits of cervical screening. In 1991, the Organised Approach to Preventing Cancer of the Cervix was established as a joint initiative of the Australian and state and territory governments. In 1995, it was renamed the National Cervical Screening Program.[14]

The NCSP promotes routine screening with Pap smears every two years for women between the ages of 18 and 69 years.[15] It aims to reduce cervical cancer prevalence and mortality, by detecting and treating cervical abnormalities before they progress to cancer. The Pap smear is usually conducted in a primary care setting, usually by a GP or practice nurse or at community or women’s health centres, family planning clinics or sexual health clinics. Incentive payments are available to encourage GPs to screen under-screened women, that is, women in the target group who have not had a cervical smear in the last four years.[16]

Since commencing in 1991, the incidence and mortality of cervical cancer has halved, although for Indigenous women incidence and mortality remain higher.[17]

Screening involves the following steps:

•        encouraging all eligible women to enter and remain in the screening program

•        ensuring optimal quality of Pap smears by adequate training of Pap smear takers

•        ensuring optimal quality of Pap smear reading through a quality assurance program for laboratories

•        ensuring appropriate follow-up of abnormal Pap smears through management guidelines

•        providing an efficient system for notifying results to women by Pap smear providers

•        providing recall and reminder systems to ensure adequate follow-up of women with screen-detected abnormalities

•        maintaining women’s participation in the program by encouraging providers to set-up reminder systems, and developing cervical screening registers, and

•        reporting on national performance measures and contributing to national cancer data.[18]

The cost of the Pap smear involves paying the consultation and the pathology fee, both of which are Medicare rebateable. If the practice and pathology provider bulk bills there is no cost to the patient.

The NCSP is jointly funded by the Commonwealth and the states and territories, however, most funding is provided by the Commonwealth in the form of Medicare benefits.

As well as the NCSP, the Australian Government funds the National Human Papillomavirus (HPV) Vaccination program for girls and boys.[19]

NCSP renewal

From May 2017, the two yearly Pap smear will be replaced with the HPV test. This test detects the presence of HPV infection, the precursor to cancer of the cervix. The HPV test will only be required for women aged 25 to 74 years once every five years. This decision follows a recommendation from the independent expert clinical body, the Medical Services Advisory Committee (MSAC).[20]

Participation in the NCSP

The Australian Institute of Health and Welfare (AIHW) collects and publishes data on the NCSP. Its most recent report covers the period 2013 and 2014.[21] The report found:

•        in 2013 and 2014, more than 3.8 million women participated in the NCSP. This was 57 per cent of women in the target population (aged 20–69)

•        the age-standardised participation rate of 58 per cent has not changed since 2011–12

•        participation differed across remoteness areas, with the highest participation of 59 per cent in inner regional areas, and the lowest of 52 per cent in very remote areas and

•        participation rose with increasing socioeconomic status, from 52 per cent for women in the lowest socioeconomic group to 64 per cent for women in the highest socioeconomic group.

Data on screening for Indigenous women is not available, as Indigenous status is not recorded on pathology request forms in some jurisdictions, although evidence suggests that Indigenous women are under-screened.[22]

Current Cervical Cancer Register arrangements

Cervical screening registers currently operate in each state and territory.[23] These registers are operated primarily by state health departments, with the exceptions of Victoria, South Australia (SA) and New South Wales (NSW).

In Victoria the Victorian Cervical Cytology Register is operated by the Victorian Cytology Service (VCS), which is described on its website as a health promotion charity. The VCS also operates the SA Cervix Screening Registry on behalf of the SA Health Department.[24]

In NSW the Pap Test Register is operated by the Cancer Institute NSW, a company limited by guarantee and created by the Cancer Institute (NSW) Act 2003 (NSW). In 2013, the Cancer Institute NSW became a pillar (support organisation) of the NSW health system. This now sees the Institute governed under the Health Services Act 1997 (NSW) and the NSW Public Sector governance and accountability framework.[25]

In order for the Register to operate nationally, states and territories will need to agree to transition the information contained in their current registers to the national Register. Those that do not agree to this will continue operating their own registers.[26] The Register was discussed at a Health Minister’s meeting, but the views of the states and territories remain unknown at the time of writing.[27]

National Bowel Cancer Screening Program

The National Bowel Cancer Screening Program[28] (NBCSP) was initiated by the Australian Government in 2006 in partnership with state and territory governments to detect bowel cancer early in order to reduce the number of Australians who die each year from the disease.

Participants are sent a free, home-based screening kit in the post around the time of their birthday. Once bowel samples are collected, patients send these to a pathology laboratory in the reply paid envelope provided in the kit. Participation is voluntary and there is no cost involved in completing the test. Test results are then sent back to the participant and a copy is also sent to the participant’s nominated doctor. Participants with a positive result are advised to see their doctor to discuss the result and for referral to further diagnostic testing, usually a colonoscopy. These follow-up health services are usually provided through state and territory government health services or private health services.[29]

The NBCSP is currently inviting those turning 50, 55, 60, 64, 65, 70, 72 and 74 to take part.

Expansion

In the 2014 Budget, the Australian Government announced an expansion of the NBCSP which involved the introduction of two-yearly screening for all Australians aged 50 to 74 by 2020.[30] This expansion is being implemented in stages. This was based on clinical trial evidence which indicated that two yearly screening could prevent between 300 and 500 deaths per year.[31]

Between 2015 and 2020, the following age groups will be added to the screening program:

•       2017—68, 58 and 54 year olds

•       2018—62 and 66 year olds.

Those aged 52 and 56 will be included from 2019 to 2020.

From 2015, people turning 70 or 74 will also be invited to screen. Other age groups will then be added progressively to achieve the target that by 2020 all Australians aged 50 to 74 will be invited to screen every two years.[32]

Participation

Participation rates in the NBCSP are lower than in the NCSP. The AIHW collects and publishes data on the NBCSP. Its most recent report covers the period from 2013 to 2014. The report found:

•       of the 2.24 million eligible people invited to screen in 2013 and 2014, around 836,000 participated in the NBCSP, for a participation rate of 37 per cent

•       males (35 per cent) had a lower participation rate than females (40 per cent)

•       participation rates increased with age, from 29 per cent in the 50 to 54 age group to 44 per cent in the 65 to 69 age group and

•       the participation rate has fallen from 44 per cent in 2007–2008 to 37 per cent in 2013–2014.[33]

Current register arrangements

Currently, the Department of Human Services manages the NBCSP Register nationally on behalf of the Department of Health. The Register contains details such as the participant’s name, contact details, age, gender, Medicare number, results of screening tests and the name of the participant’s nominated doctor. The results of any further tests such as a colonoscopy or biopsy, are also recorded.

According to the Health Minister the current Register is ‘outdated and fragmented’.[34]

Committee consideration

Senate Standing Committee for Selection of Bills

At the time of writing, the Senate Standing Committee for Selection of Bills had deferred consideration of the NCSR Bill and the Consequential Bill.[35]

However, on 13 September 2016, the Senate referred the National Cancer Screening Register Bill 2016 and the National Cancer Screening Register (Consequential and Transitional Provisions) Bill 2016 to the Senate Community Affairs Legislation Committee for inquiry and report by 11 October 2016.[36]

Senate Standing Committee for the Scrutiny of Bills

At the time of writing, the Senate Standing Committee for the Scrutiny of Bills had not considered the NCSR Bill or the Consequential Bill.

Policy position of non-government parties/independents

Specific commentary on the provisions in this Bill from non-government parties has yet to be identified.

The Labor Party indicated that it was broadly supportive of the changes to cancer screening arrangements that were announced in the 2015–16 Budget, which relate to measures in this Bill. At the time Labor’s comments were largely about the changes to cervical cancer screening arrangements.[37] However, it has previously indicated general support for cancer screening, including expansion.[38]

More recently Labor has raised concerns around the awarding of the contract for the Register to Telstra Health. Shadow Health Minister, Catherine King described it as ‘an extraordinary step in the privatisation of Medicare’ and warned it could ‘jeopardise the patient data of every Australian.’[39] In an interview with ABC radio, Ms King described the decision as a ‘disaster when it comes to health’, which would result in the Government having to ‘pay Telstra extra’ to access important health data.[40]

During the election campaign Labor stated it ‘support[ed] the establishment of a national cancer registry’ but that the awarding of the contract to Telstra Health was ‘the wrong decision’. Nevertheless, Labor indicated it would honour the contract if elected.[41]

Comments from other parties and independents about the establishment of the cancer Register have not been identified.

Position of major interest groups

The establishment of the Register has been broadly welcomed. Pathology Australia, representing the pathology sector described it as ‘an important cancer prevention measure’. Centralisation will ‘increase efficiency as well as helping to better coordinate treatment’, according to the body.[42] The establishment of the Register was also welcomed by the Consumers Health Forum (CHF) which said it ‘will mean a much bigger database to more effectively track these two lethal diseases’.[43] The Register was also welcomed by Australian Medical Association (AMA) vice-president Dr Stephen Parnis, who reportedly said, ‘We know that cancer registries are essential for the early detection and treatment of cancers and we need to have that available in a form that is useable, that is secure and that promotes patient privacy’.[44]

However, the awarding of the tender to Telstra Health in May raised some concerns around privacy and security.[45] Technology expert Anthony Harrowell points out that the contract awarded to Telstra Health—reportedly worth $220 million—had two objectives. One was to provide:

… a contact database linked to electronic or paper-based reminders not containing sensitive information; and the other being a full personal “cancer” health record containing test results, treatments and other highly sensitive information.[46]

While conceding a telecommunications company would be equipped to deal with simple reminders to undertake cancer screening, he points out that this is very different to handling sensitive personal medical data, particularly when the company involved has experienced ‘serious data breaches’.[47]

The Australian Healthcare and Hospital Association (AHHA) while welcoming the Register, has also expressed concern over governance issues, particularly data ownership, control, access to data and responsibility for compilation and release of reports.[48]

Privacy issues have sometimes featured in past debates about the use of personal health data such as during the development of the electronic health record (now called the My Health Record).[49] However, a recent opinion poll indicates that public support for the sharing of personal health data for the purposes of research is relatively strong. According to the Roy Morgan poll undertaken for Research Australia, some 91 per cent of those surveyed supported the sharing of their de-identified medical data if it was used for research. Some 60 per cent supported health officials using their data to track diseases.[50] Whether concerns over privacy in relation to the Register will escalate may depend on how well the public is informed about the Register’s role in research and in helping to prevent disease.

Managing director of Telstra Health Shane Solomon explained to the ABC how the organisation would use four recently acquired health businesses to build and administer the Register, and that their intent is to use ‘modern digital technologies of SMS, email, internet portals to make sure that we don't lose track of people at a time when they need to be screened’.[51]

According to media reports, the current operator of the Victorian and South Australian registers, the not-for-profit Victorian Cytology Service (CVS) which reportedly tendered for the contract has been approached by Telstra Health for access to its expertise and staff.[52]

The cooperation of state and territory governments will be needed to ensure screening information contained in their registers is transferred to the new Register. Some discussion with the states and territories over the Register has been done through the Council of Australian Governments (COAG) Health Council. The Commonwealth’s new investments in the national Cancer Screening Register were discussed at the Health Minister’s meeting in August 2015.[53] However, no further commentary from state governments has been identified.

Financial implications

The Explanatory Memorandum states that the Government is providing $178.3 million in funding for the establishment of the Register. On top of the $148.4 million already committed the Government provided an additional $29.9 million in the 2016–17 Budget.[54]

Costs associated with setting up the Register will be partially offset by future savings from the discontinuation of the NBSCP Register which is currently operated by Human Services.

It is not clear if this funding includes the value of the contract awarded to Telstra Health, which media reports suggests is in the vicinity of $220 million.[55]

Statement of Compatibility with Human Rights

As required under Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011 (Cth), the Government has assessed the Bills’ compatibility with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of that Act. The Government considers that the Bills are compatible.[56]

Parliamentary Joint Committee on Human Rights

At the time of writing, the Parliamentary Joint Committee on Human Rights had not considered the NCSR Bill or the Consequential Bill.

Key issues and provisions

Part 1 of the NCSR Bill contains preliminary provisions, including commencement information, a simplified outline of the Bill, definitions of key terms and meanings. It also has provisions stating that the Bill binds the Crown and that it applies to all external territories.

Important definitions central to the Bill include the definition of ‘key information’ and ‘protected information’. ‘Key information’ covers a broad range of personal information including an individual’s name, address, contact details, date of birth, gender, health care identifier and Medicare number. In relation to the information associated with cervical cancer screening, key information also includes information about an individual’s sex and an individual’s HP vaccination status. The definition of ‘key information’ is defined very broadly to also include any other information of a kind relevant to the purposes of the Register and prescribed by the rules for the purposes of this definition. ‘Protected information’ is defined as personal information or information that is commercial-in-confidence that is included in the Register or obtained under or in accordance with this Act. It includes information derived from a record of information in the Register or otherwise obtained under the Act. The definition of ‘personal information’ relies on the equivalent definition in the Privacy Act 1988.[57]

Part 2 of the NCSR Bill (clauses 8-15) establishes the Register and its legal framework.

Subclause 9(1) requires the Commonwealth to establish and keep the Register. Ownership is not specified, but the Explanatory Memorandum notes that the Commonwealth will be the custodian of data in the Register.[58] Subclause 9(2) allows for parts of the Register to be kept separately. This will allow information from the NCSP to be kept separate from information from the NBCSP, so as to prevent unnecessary disclosure.[59]

Clause 11 sets out the types of information that may be collected for inclusion in the Register. Amongst other things, the Register may include an individual’s ‘key information’ (defined in clause 4); details of an individual’s healthcare provider; information about screening tests undergone; disease diagnosis; claims information including from Medicare; details of requests about, or withdrawals from, participation in the Register; and any other information prescribed by the rules. The Explanatory Memorandum provides more detailed explanation of clause 11.[60]

Clause 12 sets out the purposes of the Register, which include:

•       keeping electronic records relating to screening and diagnoses of the two designated cancers

•       collecting, analysing and publishing statistics

•       monitoring the effectiveness, quality and safety of screening

•       providing individuals with invitations to undergo screening

•       providing individuals with a test kit for screening

•       advising individuals when they are due to undergo screening or of any action needed to be taken after screening

•       advising participating state and territories of any required action for an individual residing in their jurisdiction[61]

•       providing an individual with access to information about their screening and diagnoses

•       providing a healthcare provider with access to information about an individual’s screening and diagnoses so the individual can be provided with healthcare

•       providing participating states and territories with access to information about screening and diagnoses in their jurisdictions

•       planning, delivering and promoting health services in relation to the designated cancers

•       reporting to international bodies in relation to the designated cancers

•       research relating to health care, screening or a designated cancer and

•       anything incidental to the above.

Proposed subclause 12(2) provides that references to an individual in this section also cover references to an individual’s personal representative.

The Explanatory Memorandum explains the purposes of the Register in more detail.[62]

Subclause 13(1) places an obligation on prescribed health care providers to notify the Chief Medical Officer of information prescribed by the rules in relation to screening tests and diagnoses in an approved form, within a prescribed timeframe. Failure to comply with this obligation results in a civil penalty of 30 penalty units[63] (subclause 13(2)). However this penalty will only apply from 1 May 2018 (item 6 in the Consequential Bill).

Clause 14 allows an individual (or their personal representative) in the approved form to alter their participation in the Register. For example an individual may request to opt out of the Register, limit their participation, choose not to have their information recorded, or use a pseudonym. The Explanatory Memorandum indicates this can be done by individuals using the self-service facility on the Register.[64] The Commonwealth must act on such requests ‘as soon as practicable’ (subclause 14(3)). The Explanatory Memorandum notes that these provisions are designed to protect individual privacy. However, in order ‘to ensure Register data is not compromised’ the provision operates prospectively and will not apply to information already collected.[65]

Clause 15 of the NCSR Bill provides a number of ‘alternative’ constitutional bases for the validity of the Bill. Legislation must be supported by a Constitutional head of power. The High Court has also established that Commonwealth spending must be supported by a valid head of power. [66] Like most legislation, the Bill can possibly be founded on more than one head of power. This provision has the effect that if the High Court were to find that some of the provisions were not properly founded on a particular power, then the Act would still stand to the extent that another head or heads of power provides a valid Constitutional basis.

Part 3 of the NCSR Bill (clauses 16-22) deals with the use and disclosure of information in the Register. Clause 17 deals with collection, use and disclosure of information for the Register. Subclause 17(1) provides that a person may collect, make a record of, disclose or otherwise use information if it is for the purposes of uploading the information in the Register—information here refers to personal information, key information or information that is commercial-in-confidence (all defined in clause 4). The specific circumstances where collecting, recording, using or disclosing protected information or key information from the Register is authorised are provided in subclause 17(3) of the Bill. Amongst other things the authorised categories include:

•       an officer or employee of the Commonwealth, a person engaged by the Commonwealth to perform work related to the purposes of the Register or prescribed body where the collection, recording, disclosure or use is for the purposes of the Register

•       a healthcare provider where the information is about screening or diagnosis associated with the two designated cancers

•       a participating state or territory authority where the collection, recording, disclosure or use is required or permitted by the law of the state or territory

•       where the person does so for the purposes of performing the person’s functions, or exercising the person’s powers under this Bill

•       where the collection, recording, disclosure or use is required or authorised by or under a law of the Commonwealth or of a state or territory

•       where the information is disclosed to the person under this section and the collection, recording, disclosure or use is for the purposes for which the information was disclosed to the person

•       the Secretary where the collection, recording, disclosure or use is for the purpose of disclosing information to a professional disciplinary body or child protection officer and the Secretary reasonably believes that the information will enable or assist them to perform or exercise any of their functions or powers

•       where the person does so for the purposes of court or tribunal proceedings, or a coronial inquiry.

Clause 18 creates an offence arising from the unauthorised disclosure or use of protected information contained in the Register. Persons who record, use or disclose protected information and are not authorised to do so under clause 17 of the Bill are subject to a maximum penalty of imprisonment for two years or 120 penalty units, or both.[67] A question that might be asked is why this offence provision only applies to the misuse of protected information and not to the misuse of key information.[68] The Explanatory Memorandum does not explain the rationale for this distinction.

Clauses 19 to 22 specify exceptions in relation to clause 18. If the person discloses or uses protected information in good faith, or is unaware it is commercial-in-confidence, or discloses the information to the person to whom the information relates or discloses information to a person who has already provided the information, they are exempt from the offence provision at clause 18. In each case the defendant would bear an evidential burden of proving the exemption.[69]

Part 4 (clauses 23 to 28) deals with miscellaneous matters.

Clause 24 specifies that the civil penalty provisions are enforceable under Part 4 of the Regulatory Powers (Standard Provisions) Act 2014.[70]

Clause 26 authorises the Minister on behalf of the Commonwealth to enter into a written agreement to perform services in relation to the Register. This clause is important as it allows the Commonwealth to contract out the operation of the Register. As noted earlier, the tender to operate the Register has been awarded to Telstra Health.

Clause 28 provides that the Minister may by legislative instrument make rules to prescribe matters required or permitted to be prescribed under the Bill and more generally to make rules necessary or convenient to be prescribed for carrying out or giving effect to the Bill (when enacted). Subclause 28(2) sets out the limits on the scope of the rule making power—for example, rules may not create an offence or civil penalty or directly amend the text of the Bill (when enacted).

Consequential and Transitional provisions

The National Cancer Screening Register (Consequential and Transitional Provisions) Bill 2016 (the Consequential Bill) deals with consequential amendments and transitional matters related to the enactment of the NCSR Bill. Part 1 to Schedule 1 of the Bill makes amendments to three Acts. Part 2 deals with the application of provisions and transitional arrangements.

Item 1 inserts new paragraph 22(2)(ca) into the Australian Immunisation Register Act 2015.[71] Section 22 of this Act sets out the authorised dealings with protected information in the Australian Immunisation Register. Item 1 amends section 22 so that protected information from the Australian Immunisation Register such as an individual’s HPV Vaccination status is allowed to be disclosed to the Register.

Item 2 amends Schedule 3 of the Freedom of Information Act 1982[72] (FOI Act). Schedule 3 of the FOI Act provides a list of secrecy provisions in various Acts that are exempt from FOI requests under section 38 of the FOI Act. Item 2 adds to this list the offence provision specified at section 18 of the NCSR Bill.[73] The Explanatory Memorandum explains that item 2 has the effect of ensuring that protected information in the Register is exempt from FOI requests if disclosure of that information would be an offence under clause 18 of the NCSR Bill.[74]

Item 3 amends section 130 in the Health Insurance Act 1973.[75] Section 130 is a secrecy provision and prohibits the disclosure of health insurance information subject to certain exceptions. Item 3 inserts new subsection 130(5H), to add an additional exception allowing the provision of Medicare information for inclusion in the Register kept under the NCSR Act. The Explanatory Memorandum states that this will enable the initial data migration and ongoing provision of Medicare enrolment and claim data to the Register.[76]

Item 4 specifies definitions which are explained in the Explanatory Memorandum.[77]

Item 5 authorises the transfer of information from state and territory cervical screening registers to the Register. Information on cervical screening is currently held in registers operated by the states and territories. Subitem 5(3) provides that the Minister may make rules by legislative instrument that prescribe state and territory registers or databases that contain information relevant to cervical cancer screening. This provision applies regardless of any laws that would otherwise prohibit the transfer of such information (subitem 5(4)).

Item 6 specifies that the penalty provisions applying to a health care provider at subsection 13(2) of the National Cancer Screening Register Act 2016, for failing to notify the Chief Medical Officer of prescribed information, do not apply before 1 May 2018. As the Explanatory Memorandum explains, this will give health care providers time to transition to the notification requirements.[78]

Concluding comments

Together, these two Bills establish the National Cancer Screening Register and the legislative framework for its operation. The Register will underpin national screening programs for cervical cancer and bowel cancer, diseases which impose a considerable burden on individuals, families and the community more generally. While the proposal for a national Register is broadly supported, some disquiet exists around privacy and the awarding of the contract to operate the new Register to the private company Telstra Health.

Members, Senators and Parliamentary staff can obtain further information from the Parliamentary Library on (02) 6277 2500.

© Commonwealth of Australia

Creative Commons

With the exception of the Commonwealth Coat of Arms, and to the extent that copyright subsists in a third party, this publication, its logo and front page design are licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Australia licence.

In essence, you are free to copy and communicate this work in its current form for all non-commercial purposes, as long as you attribute the work to the author and abide by the other licence terms. The work cannot be adapted or modified in any way. Content from this publication should be attributed in the following way: Author(s), Title of publication, Series Name and No, Publisher, Date.

To the extent that copyright subsists in third party quotes it remains with the original owner and permission may be required to reuse the material.

Inquiries regarding the licence and any use of the publication are welcome to webmanager@aph.gov.au.

Disclaimer: Bills Digests are prepared to support the work of the Australian Parliament. They are produced under time and resource constraints and aim to be available in time for debate in the Chambers. The views expressed in Bills Digests do not reflect an official position of the Australian Parliamentary Library, nor do they constitute professional legal opinion. Bills Digests reflect the relevant legislation as introduced and do not canvass subsequent amendments or developments. Other sources should be consulted to determine the official status of the Bill.

Any concerns or complaints should be directed to the Parliamentary Librarian. Parliamentary Library staff are available to discuss the contents of publications with Senators and Members and their staff. To access this service, clients may contact the author or the Library’s Central Enquiry Point for referral.

[1].              Parliament of Australia, ‘National Cancer Screening Register Bill 2016 homepage’, Australian Parliament website; and Parliament of Australia, National Cancer Screening Register (Consequential and Transitional Provisions) Bill 2016 homepage, Australian Parliament website.

[2].              Explanatory Memorandum, National Cancer Screening Register Bill 2016, p.1.

[3].              Australian Government, Budget measures: budget paper no. 2: 2015–16, p. 105.

[4].              Australian Government, Budget measures: budget paper no. 2: 2016–17, p. 110.

[5].              Department of Health (DoH), National Cancer Screening Register, media release, 26 May 2016; M Kenny, ‘Telstra wins deal to manage cancer records’, Sydney Morning Herald, 26 May 2016, p. 9.

[6].              DoH, National Cancer Screening Register, op. cit.

[7].              Australian Institute of Health and Welfare (AIHW), ‘Bowel cancer (colorectal cancer)’, AIHW webpage.

[8].              AIHW, ‘Cervical cancer’, AIHW webpage.

[9].              J H Williams, S M Carter and L Rychetnik, ‘Organised cervical screening 45 years on: How consistent are organised screening practices?’, European Journal of Cancer, 50 (17), November 2014, pp. 3029–3038, see Box 1.

[10].              Ibid.

[11].              M von Euler-Chelpin, E Lynge and M Rebolj, ‘Register-based studies of cancer screening effects’, Scandinavian Journal of Public Health, 39 (Suppl 7), 2011, pp. 158–164.

[12].              Williams, Carter, Rychetnik, ‘Organised cervical screening 45 years on’, op. cit., p. 3034.

[13].              DoH, ‘National Cervical Screening Program: About the Program’, DoH webpage, last updated 5 November 2013.

[14].              Ibid.

[15].              The test involves a health practitioner taking a cell sample from the cervix, which is then sent to a laboratory and tested for abnormalities.

[16].              Department of Human Services (DHS), ‘Practice Incentives Program: cervical screening incentive’, DHS webpage, last updated 7 September 2016.

[17].              AIHW, Cervical screening in Australia 2013–2014, Cancer series, 97, AIHW, Canberra, 3 May 2016, p. vii.

[18].              DoH, ‘National Cervical Screening Program: About the Program’, DoH webpage, last updated 5 November 2013.

[19].              The HPV virus is a contagious virus that can lead to cell changes which can then progress to cancer. The HPV vaccine is provided free in schools to all males and females aged 12-13 years under the National HPV Vaccination Program. See DoH, ‘Immunise Australia Program: Human Papillomavirus’, DoH webpage, last updated 31 May 2016.

[20].              Medical Services Advisory Committee (MSAC), ‘Public summary document: renewal of the National Cervical Screening Program’, MSAC application, 1276, MSAC meeting, 3–4 April 2014, p. 9.

[21].              AIHW, Cervical screening in Australia 2013–2014, op. cit.

[22].              Ibid.

[23].              These are listed at DoH, ‘About the program register’, DoH webpage, last updated 5 November 2013.

[24].              Victorian Cytology Service (VCS), ‘What we do’, VCS webpage.

[25].              Cancer Institute NSW, ‘History of the Cancer Institute NSW’, Cancer Institute NSW webpage, published 13 July 2016.

[26].              Explanatory Memorandum, National Cancer Screening Register Bill 2016, op. cit., p. 8.

[27].              Council of Australian Governments (COAG) Health Council, ‘Communique’, COAG Health Council meeting, Darwin, 7 August 2015.

[28].              DoH, ‘National Bowel Cancer Screening Program’, DoH webpage.

[29].              DoH, ‘Fact sheet: bowel cancer’, DoH webpage, May 2016, page last updated 22 September 2016.

[30].              Australian Government, Budget measures: budget paper no. 2: 2014-15, 2014, p. 129. The expansion was also a Coalition election commitment, Liberal Party of Australia and the Nationals, The Coalition's policy to support Australia's health system, Coalition policy document, August 2013, p. 14.

[31].              Explanatory Memorandum, National Cancer Screening Register Bill 2016, op. cit., p. 3.

[32].              DoH, ‘About the Program’, DoH webpage, page last updated 2 May 2016.

[33].              AIHW, National Bowel Cancer Screening Program: monitoring report 2016, Cancer series, 98, AIHW, Canberra, 2016, pp. 16–17.

[34].              S Ley (Minister for Health and Aged Care), New National Cancer Register aims to save lives, media release, 31 August 2016.

[35].              Senate Standing Committee for Selection of Bills, Report, 5, 2016, The Senate, 1 September 2016.

[36].              Senate Standing Committee on Community Affairs, Inquiry into the National Cancer Screening Register Bill 2016 and National Cancer Screening Register (Consequential and Transitional Provisions) Bill 2016, The Senate, Canberra, 2016.

[37].              C King (Shadow Minister for Health), Transcript of doorstop interview: Canberra: 13 May 2015: Cancer Council Biggest Morning Tea, transcript, 13 May 2015.

[38].              Australian Labor Party (ALP), National Platform: a smart, modern, fair Australia, ALP policy document, 18 August 2015, p. 110.

[39].              C King (Shadow Minister for Health), Turnbull continues Medicare privatisation, media release, 26 May 2016.

[40].              C King (Shadow Minster for Health), Transcript of interview with Michael Brissenden: ABC AM: Medicare privatisation; same sex marriage plebiscite; Labor candidate for Farrer, transcript, 20 June 2016.

[41].              J Lee, ‘Fears that firms could profit from cancer data’, Canberra Times, 27 May 2016, p. 4.

[42].              Pathology Australia, Cancer register right for women, media release, 31 August 2016.

[43].              Consumers Health Forum, Cancer register boosts fight against bowel and cervical cancers, media release, 1 September 2016.

[44].              L Carter, ‘Telstra wins contract for new National Cancer Screening Register’, ABC news, 26 May 2016.

[45].              M Kenny, ‘Fears over privacy as Telstra wins deal to manage cancer patients' records’, Canberra Times, 26 May 2016.

[46].              A Harrowell, ‘Scrutiny needed on Telstra Health’, The Australian, 7 June 2016, p. 28.

[47].              Ibid. A serious data breach by Telstra in 2013 prompted an investigation by the Australian Privacy Commissioner, see, P Wood, ‘Telstra information leak breached laws’, Herald Sun, 12 March 2014.

[48].              AHHA, Health data a national asset; how will Telstra deliver on cancer registries?, media release, 26 May 2016.

[49].              A Biggs, Health Legislation Amendment (eHealth) Bill 2015, Bills digest, 41, 2015–16, Parliamentary Library, Canberra, 2015, p. 10, p. 14.

[50].              Research Australia, New poll: Australians will share their personal health data if privacy protected, media release, 7 September 2016.

[51].              L Carter, ‘Telstra wins contract for new National Cancer Screening Register’, op. cit.

[52].              P Dinham, ‘Telstra attacked over $220 million cancer screening register contract win’, ITWire, 26 May 2016; see also M Kenny, ‘Fears over privacy as Telstra wins deal to manage cancer patients’ records’, op. cit.

[53].              COAG Health Council, Communique, COAG Health Council meeting, Darwin, 7 August 2015.

[54].              Explanatory Memorandum, National Cancer Screening Register Bill 2016, op. cit., p. 2.

[55].              Harrowell, ‘Scrutiny needed on Telstra Health’, op. cit.

[56].              The Statement of Compatibility with Human Rights can be found at page 3 of the Explanatory Memorandum to the NCSR Bill and at page 5 of the Explanatory Memorandum to the Consequential Bill.

[57].              Privacy Act 1988.

[58].              Explanatory Memorandum, National Cancer Screening Register Bill 2016, op. cit., p. 11

[59].              Ibid.

[60].              Ibid., pp. 11–14.

[61].              A participating state or territory is one that has agreed with the Commonwealth to participate in the register (clause 4).

[62].              Ibid., pp. 14–18

[63].              A penalty unit is currently equal to $180, so the maximum civil penalty is currently $5,400 (subsection 4AA(1) of the Crimes Act 1914).

[64].              Ibid., p. 19.

[65].              Ibid.

[66].              Pape v Commissioner of Taxation (2009) 238 CLR 1, [2009] HCA 23; Williams v Commonwealth of Australia (2012) 248 CLR 156, [2012] HCA 23; and Williams v Commonwealth of Australia (2014) 252 CLR 416, [2014] HCA 23.

[67].              A penalty unit is currently equal to $180, therefore the maximum pecuniary penalty under this provision is $21,600 (subsection 4AA(1) of the Crimes Act 1914).

[68].              Protected information and key information are defined in clause 4 and are described above.

[69].              Generally, where a burden of proof is placed on a defendant it is an evidential burden only (Criminal Code Act 1995, subsection 13.3(1)). The evidential burden can be discharged by the defendant pointing to evidence suggesting there was a reasonable possibility that a matter existed or did not exist (Criminal Code, subsection 13.3(6)).

[70].              The Regulatory Powers Act ‘seeks, over time, to systematise the monitoring and investigatory powers provided to Commonwealth regulatory agencies. To do that, the [Act] seeks to act as the standard framework to which other legislation refers, in order to trigger its provisions that are relevant to a particular agency or authority’ – see J Murphy, Regulatory Powers (Standard Provisions) Bill 2014, Bills digest, 73, 2013–14, Parliamentary Library, Canberra, 2014, p. 3.

[71].              Australian Immunisation Register Act 2015.

[72].              Freedom of Information Act 1982.

[73].              See Murphy, Regulatory Powers (Standard Provisions) Bill 2014, 2014, op. cit., p. 11; for an explanation of proposed section 18 of the NCSR Act.

[74].              Explanatory Memorandum, National Cancer Screening Register (Consequential and Transitional Provisions) Bill 2016, p. 10.

[75].              Health Insurance Act 1973.

[76].              Explanatory Memorandum, National Cancer Screening Register (Consequential and Transitional Provisions) Bill 2016, op. cit., p. 10.

[77].              Ibid., p. 10.

[78].              Ibid., p. 11.