National Cancer Screening Register Amendment Rules 2018

EXPLANATORY STATEMENT

Issued by the Authority of the Minister for Health

National Cancer Screening Register Act 2016

National Cancer Screening Register Amendment Rules 2018

Authority for this Instrument 

Section 28 of the National Cancer Screening Register Act 2016 (the Act) provides that the Minister may make rules prescribing matters required or permitted by the Act to be prescribed by the rules or which are necessary or convenient to be prescribed in order to carry out or give effect to the Act.

The National Cancer Screening Register Rules 2017 (the NCSR Rules) were made pursuant to section 28 of the Act.

The National Cancer Screening Register Amendment Rules 2018 (the Instrument) amends the NCSR Rules. The Instrument is made for the purposes of subsection 13(1) of the Act.

The Instrument is a legislative instrument for the purposes of the Legislation Act 2003.

In addition to the power to make this Instrument under section 28 of the Act, subsection 33(3) of the Acts Interpretation Act 1901 provides that where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character (including rules, regulations or by-laws), the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument.

Overview of the Act

The Act creates a legislative framework for the establishment and ongoing operation of the National Cancer Screening Register (the Register).

The Act authorises the collection, use and disclosure of information for the purposes of the Register to support the renewed National Cervical Screening Program and the expansion of the National Bowel Cancer Screening Program; and mandates the reporting of prescribed cancer screening information to the Register. The routine collection of this information is crucial for screening processes and the clinical pathways.

Overview of the NCSR Rules

For the purposes of subsection 13(1) of the Act, the NCSR Rules prescribe:

• types of cervical cancer screening tests; and
• for each of those types of screening tests -

-       the information that must be notified to the Commonwealth Chief Medical Officer (CMO) in the approved form;

-       the individual healthcare provider who must notify the information; and

-       the time by which the information must be notified.

The prescribed screening tests are as follows:

• colposcopy;
• human papillomavirus test;
• cytology test; and
• histopathology.

Consultation

State and Territory governments were consulted in relation to this amendment and feedback received from colposcopists was also considered.

Overview of amendment

Section 8 of the NCSR Rules is about colposcopies. Where a colposcopy is carried out on an individual in accordance with subsection 8(1), subsection 8(2) requires the notification of specified information about the individual, including the individual’s indigenous status (if known), country of origin (if known) and preferred language (if known), to the CMO by the end of 14 days after the day the colposcopy is completed.

Under subsection 8(3), the individual’s indigenous status, country of origin and preferred language do not have to be notified to the CMO before 1 June 2018.

The purpose of this amendment is to allow sufficient time for the Register to implement the processes that are necessary to collect this information and for colposcopists to prepare to report indigenous and culturally and linguistically diverse (CALD) demographic details.

Details of the Amendment

Item 1 of the Schedule in the Instrument substitutes “1 June 2018” in subsection 8(3) of the NCSR Rules with “1 December 2018”. The effect of this amendment is that the individual’s indigenous status, country of origin and preferred language do not have to be notified to the CMO before 1 December 2018.

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011 (Cth).

The National Cancer Screening Register Amendment Rules 2018 (this Instrument) is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011 (Cth).

Overview of the National Cancer Screening Register Act 2016

The National Cancer Screening Register Act 2016 (the Act) creates a legislative framework for the establishment and ongoing operation of the National Cancer Screening Register (the Register).

The Act authorises the collection, use and disclosure of information for the purposes of the Register to support the renewed National Cervical Screening Program and the expansion of the National Bowel Cancer Screening Program; and mandates the reporting of prescribed cancer screening information to the Register. The routine collection of this information is crucial for screening processes and the clinical pathways.

Overview of the National Cancer Screening Register Rules 2017

For the purposes of subsection 13(1) of the Act, the National Cancer Screening Register Rules 2017 (the NCSR Rules) prescribe:

• types of cervical cancer screening tests; and
• for each of those types of screening tests -

-       the information that must be notified to the Commonwealth Chief Medical Officer (CMO) in the approved form;

-       the individual healthcare provider who must notify the information; and

-       the time by which the information must be notified.

The prescribed screening tests are as follows:

• colposcopy;
• human papillomavirus test;
• cytology test; and
• histopathology.

Overview of this Instrument

This Instrument is made under section 28 of the Act and deals with an amendment to the NCSR Rules regarding the requirement to notify an individual’s indigenous status, country of origin and preferred language to the CMO after a colposcopy has been carried out on the individual.

Where a colposcopy is carried out on an individual in accordance with subsection 8(1) of the NCSR Rules, subsection 8(2) of the Rules requires the notification of prescribed information about the individual, including the individual’s indigenous status, country of origin and preferred language, to the CMO by the end of 14 days after the day the colposcopy is completed. This information is only required to be provided if it is known by the individual healthcare provider.

Under subsection 8(3) of the NCSR Rules, the individual’s indigenous status, country of origin and preferred language are not required to be notified to the CMO before 1 June 2018.

This Instrument amends subsection 8(3) of the NCSR Rules so that the individual’s indigenous status, country of origin and preferred language are not required to be notified to the CMO before 1 December 2018.

The purpose of this amendment is to allow sufficient time for the Register to implement the processes that are necessary to collect this information and for colposcopists to prepare to report indigenous and CALD demographic details.

Human rights implications

The Act and NCSR Rules engage the following rights:

• Protection of privacy and reputation (Article 17 of the International Covenant on Civil and Political Rights (ICCPR); and
• Right to health (Articles 2 and 12(1) of the International Covenant on Economic, Social and Cultural Rights (ICESCR).

Protection of privacy and reputation

Article 17 of the ICCPR prohibits arbitrary or unlawful interference with an individual’s privacy, family, home and correspondence. For interferences with privacy not to be arbitrary, they must be reasonable in the particular circumstances. Reasonableness, in this context, incorporates notions of proportionality to the end sought and necessity in the circumstances.

The Act

The Act engages Article 17 of the ICCPR by the provisions that allow the Register to collect, record, use and disclose personal information for various purposes associated with the Register.

There are various safeguards included in the Act to protect an individual’s right to privacy.

Safeguards include imposing limitations on the collection, recording, disclosure or use of information in the Register.  The Act describes when collection, recording, disclosure and use are authorised.  The purposes for which information can be used or disclosed are a reasonable and proportionate limitation on an individual’s right to privacy since the authorised disclosures are for specific legitimate purposes and limited to what is required to achieve the purposes of the National Cervical Screening Program and National Bowel Cancer Screening Program.

In addition, participation in the Register is voluntary. The Act allows individuals to opt out of participating in the Register and/or screening programs, including requesting that their screening test results not be included in the Register. When an individual opts out in accordance with the Act, the individual’s personal information continues to be protected under the Act.

The offence provision for unauthorised use or disclosure aims to provide appropriate safeguards to protect against arbitrary and unlawful interference with privacy.

The NCSR Rules

The NCSR Rules engage Article 17 of the ICCPR by provisions that prescribe the collection of individuals’ cervical screening test results, results of relevant follow-up procedures up to and including the diagnosis (or clearance) of cancer, and treatment in relation to pre-cancerous abnormalities to be notified to the CMO through the Register.

Information notified to the CMO pursuant to the NCSR Rules is afforded the safeguards provided in the Act.

Right to health

The Act

The Act engages Articles 2 and 12 of the ICESCR by establishing the Register for the purpose of supporting early detection and prevention of cancer through screening. 

According to the World Health Organisation, the aim of screening for a disease or a risk marker for a disease is “to reduce the burden of the disease in the community, including incidence of disease, morbidity from the disease or mortality.  This is achieved by intervening to reduce individual risk of the disease or detecting the disease earlier on average than is usually the case in the absence of screening and thereby improving disease outcome.”

The requirement in the Act to notify to the Register will allow individuals’ screening test results/outcome data and results of relevant follow-up procedures up to and including the diagnosis (or clearance) of cancer (collectively referred to as screening test or diagnosis) to be routinely notified to the Register.   Complete and accurate data will allow the screening processes and clinical pathways to operate safely, efficiently and effectively.   

The NCSR Rules

The NCSR Rules provide a legislative basis for the collection of individuals’ cervical screening test results. A ‘positive’ screening test identifies people who are at increased likelihood of having the condition and who require further investigation to determine whether or not they have the disease or condition.

The notification requirement in the NCSR Rules supports the screening processes and clinical pathways; and the monitoring of program quality, safety and effectiveness. The cervical screening test information notified by prescribed individual healthcare providers for the purpose of subsection 13(1) of the Act will be used to facilitate screening invitations, recall and clinical decision-making, thereby supporting early detection and prevention of cancer through population-based screening.

The Instrument

The Instrument amends subsection 8(3) of the NCSR Rules, which relate to subsection 13(1) of the Act.

Subsection 13(1) of the Act provides for rules to be made prescribing the individual healthcare providers who are required to notify prescribed information for a type of screening test or diagnosis by the prescribed timeframe. 

The amendment in the Instrument relates to the notification of a particular type of information – an individual’s indigenous status, country of origin and preferred language (if the healthcare provider knows this information). The amendment does not affect the privacy protections in the Act nor the reporting of other screening test information.

The purposes of requiring an individual’s indigenous status, country of origin and preferred language to be notified to the CMO are to:

• Accurately measure the screening participation rates in these subgroups;
• Enable greater understanding of screening behaviours in these sub-groups; and
• Inform targeted strategies to increase the screening participation of individuals in these subgroups in order to reduce the rate of cervical cancer in indigenous and culturally and linguistically diverse (CALD) communities.

The identification and recording of the cultural background of all patients can be an important indication of clinical risk factors and can assist health professions in providing relevant care.

Recording a patient’s preferred language and whether an interpreter is required is helpful for information provision. Collection of the indigenous status helps Aboriginal and Torres Strait Islander people access indigenous-specific health interventions which are designed to overcome the health disparities between indigenous and non-indigenous people as per the Close the Gap Initiative.

Conclusion

The Instrument is compatible with human rights and any interference with privacy is proportional and the minimum necessary to achieve the purposes of collecting the relevant information.

• The Instrument sets out an amendment changing the date when an individual’s indigenous status, country of origin and preferred language must be notified to the CMO in relation to colposcopies.

• The Instrument does not affect the reporting of other screening test information.

• The Instrument does not affect the privacy protections in the Act as referred to above. Information about an individual’s indigenous status, country of origin and preferred language was going to have to be notified to the CMO from 1 June 2018. The amendment means that this information (if known to the individual healthcare provider) will have to be notified to the CMO from 1 December 2018 instead. Once notified to the CMO, the information will be afforded the same privacy protections in the Act as other information already being notified.

• The healthcare provider is only required to notify the CMO of an individual’s indigenous status, country of origin and preferred language if the information is available to the healthcare provider at the time of the service.

The Hon Greg Hunt MP, the Minister for Health