FINANCIAL FRAMEWORK (SUPPLEMENTARY POWERS) AMENDMENT (HEALTH MEASURES NO. 2) REGULATIONS 2018 (F2018L00842) EXPLANATORY STATEMENT

Commonwealth Numbered Regulations - Explanatory Statements

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FINANCIAL FRAMEWORK (SUPPLEMENTARY POWERS) AMENDMENT (HEALTH MEASURES NO. 2) REGULATIONS 2018 (F2018L00842)

EXPLANATORY STATEMENT

 

Issued by the Authority of the Minister for Finance

 

Financial Framework (Supplementary Powers) Act 1997

 

Financial Framework (Supplementary Powers) Amendment

(Health Measures No. 2) Regulations 2018

 

The Financial Framework (Supplementary Powers) Act 1997 (the FF(SP) Act) confers on the Commonwealth, in certain circumstances, powers to make arrangements under which money can be spent; or to make grants of financial assistance; and to form, or otherwise be involved in, companies.  The arrangements, grants, programs and companies (or classes of arrangements or grants in relation to which the powers are conferred) are specified in the Financial Framework (Supplementary Powers) Regulations 1997 (the Principal Regulations).  The FF(SP) Act applies to Ministers and the accountable authorities of non-corporate Commonwealth entities, as defined under section 12 of the Public Governance, Performance and Accountability Act 2013

 

Section 65 of the FF(SP) Act provides that the Governor-General may make regulations prescribing matters required or permitted by that Act to be prescribed, or necessary or convenient to be prescribed for carrying out or giving effect to that Act.

 

Section 32B of the FF(SP) Act authorises the Commonwealth to make, vary and administer arrangements and grants specified in the Principal Regulations.  Section 32B also authorises the Commonwealth to make, vary and administer arrangements for the purposes of programs specified in the Principal Regulations.  Schedule 1AA and Schedule 1AB to the Principal Regulations specify the arrangements, grants and programs. 

 

The purpose of the Financial Framework (Supplementary Powers) Amendment (Health Measures No. 2) Regulations 2018 (the Regulations) is to amend Schedule 1AB to the Principal Regulations to establish legislative authority for government spending on eight initiatives which will be administered by the Department of Health. 

 

Funding will be provided:

*         to the Royal Flying Doctor Service to deliver dental, mental health and emergency aeromedical services in rural and remote Australia;

*         to the KIDS Foundation for the SeeMore Safety Program to prevent and reduce the effects of childhood injuries, and encourage children to adopt safe practices throughout their lives;

*         to develop resources and training to increase awareness amongst general practitioners and other clinicians of the existence, presenting symptoms of spinal muscular atrophy and referral pathways, including genetic testing for patients at risk;

*         to develop resources to increase awareness amongst general practitioners and other clinicians of the existence, presenting symptoms and possible treatments of endometriosis;

*         to develop educational materials to encourage women with gestational diabetes to undergo testing for future risk of type 2 diabetes;

*         to develop resources and educational materials for pregnant women in relation to managing weight, improving dietary habits and increasing physical activity, and commission research to inform the development of safe pregnancy physical activity guidelines;

*         for health infrastructure projects in regional and remote areas in Australia; and

*         for educational activities to increase the use of biosimilar medicines; the enhancements to software to increase the use of generic and biosimilar medicines and improve electronic prescribing and dispensing arrangements; and software changes to improve the management of controlled drugs.

 

Funding for these initiatives was included in the 2018-19 Budget and the 2017-18 Mid-Year Economic and Fiscal Outlook.

 

Details of the Regulations are set out at Attachment A.  A Statement of Compatibility with Human Rights is at Attachment B

 

The Regulations are a legislative instrument for the purposes of the Legislation Act 2003.  The Regulations commence on the day after the instrument is registered on the Federal Register of Legislation. 

 

Consultation

 

In accordance with section 17 of the Legislation Act 2003, consultation has taken place with the Department of Health.

 

A regulation impact statement is not required as the Regulations only apply to non-corporate Commonwealth entities and do not adversely affect the private sector. 

 

 

 


Details of the Financial Framework (Supplementary Powers) Amendment (Health Measures No. 2) Regulations 2018

 

Section 1 - Name

 

This section provides that the title of the Regulations is the Financial Framework (Supplementary Powers) Amendment (Health Measures No. 2) Regulations 2018.

 

Section 2 - Commencement

 

This section provides that the Regulations commence on the day after the instrument is registered on the Federal Register of Legislation. 

 

Section 3 - Authority

 

This section provides that the Regulations are made under the Financial Framework (Supplementary Powers) Act 1997.

 

Section 4 - Schedules

 

This section provides that the Financial Framework (Supplementary Powers) Regulations 1997 are amended as set out in the Schedule to the Regulations. 

 

Schedule 1 - Amendments

 

Item 1 - In the appropriate position in Part 4 of Schedule 1AB (table)

 

This item adds eight new table items to Part 4 of Schedule 1AB to establish legislative authority for government spending on initiatives administered by the Department of Health (the department).

 

New table item 286 establishes legislative authority for the Government to fund the Royal Flying Doctor Service (RFDS) to deliver rural and remote outreach services including primary aeromedical evacuations, dental outreach and mental health services.  The RFDS aims to deliver sustainable, flexible, effective and efficient services to people in areas where the normal medical infrastructure is not available and in locations of market failure.

 

Funding will be provided to the RFDS:

*         to support the delivery of 24/7 aeromedical services to people living, working and travelling in rural and remote areas of Australia who may need emergency primary aeromedical evacuation to the nearest suitable hospital as a result of life threatening illnesses or accidents;

*         to continue dental outreach services for rural and remote areas to ensure communities in areas of most need and beyond the reach of current private or state-funded services have access to dental services; and

*         to establish a mental health outreach clinic program to provide access to mental health professionals, including face-to-face psychological services, in areas where there are little or no services.

 

Funding of $84.1 million was included in the 2018-19 Budget as part of the measure 'A Stronger Rural Health Strategy' for a period of four years commencing in 2018-19.  Details are set out in Budget 2018-19, Budget Measures, Budget Paper No. 2 2018-19 at page 107. 

 

Grant funding will be provided to the RFDS through a closed, non-competitive process in accordance with the Commonwealth Grants Rules and Guidelines 2017.  The department will enter into a new funding arrangement with the RFDS, which will act as an agent for six operational sections: South East Section (NSW); Central Operations (SA and south of Tennant Creek); Western Operations (WA); Queensland Operations (QLD); RFDS Victorian Section (VIC); and RFDS of Tasmania (TAS). 

 

As the department has current funding arrangements with the RFDS, existing program guidelines will be amended and published on the departmental website at www.health.gov.au.

 

The final funding decision will be made by the Chief Medical Officer as a delegate of the Minister for Health.  The grant decision will be published on the departmental website. 

 

The provision of funds to the RFDS for delivery of primary aeromedical evacuations, dental outreach and mental health services is not considered suitable for independent merits review.

 

The RFDS is highly experienced in delivering essential fly-in and fly-out primary health care services in rural and remote Australia.  This organisation has the capital infrastructure required to continue providing primary aeromedical evacuations and dental outreach services and to establish mental health services to meet the Government's objective.  The RFDS has the demonstrated capacity and reliability required to deliver these services nationally and there are no other organisations eligible to apply.

 

The RFDS, as the single grant recipient, is required to have in place service planning arrangements approved by the Government to ensure that current services continue and new services are prioritised in areas of most need within agreed timeframes.   

 

To reconsider this decision under merits review would substantially delay implementation of the activity in a market environment where there are no alternative providers with similar capacity to provide primary aeromedical evacuations, dental outreach and mental health services in rural and remote areas nationally.

 

Funding for this item comes from Program 2.3: Health Workforce, which is part of Outcome 2.  Details are set out in the Portfolio Budget Statements 2018-19, Budget Related Paper No. 1.9, Health Portfolio at pages 31 and 63. 

 

Noting that it is not a comprehensive statement of relevant constitutional considerations, the objective of the item references the following powers of the Constitution:

*         the social welfare power (section 51(xxiiiA)); and

*         the external affairs power (section 51(xxix)).


 

Social welfare power

 

The social welfare power in section 51(xxiiiA) of the Constitution empowers the Parliament to make laws with respect to the provision of various social welfare services including 'medical and dental services'.

 

Funding will be provided for the delivery of medical and dental services in rural and remote areas through the RFDS in the form of emergency primary aeromedical evacuations, a mental health outreach clinic program, and a dental outreach program. 

 

External affairs power

 

Section 51(xxix) of the Constitution empowers the Parliament to make laws with respect to 'external affairs'.  The external affairs power supports legislation implementing Australia's obligations under international treaties to which it is a party. 

 

Australia is a party to the International Covenant on Economic, Social and Cultural Rights (ICESCR).  Article 12(1) of the ICESCR recognises the 'right of everyone to the enjoyment of the highest attainable standard of physical and mental health'.  Article 2 requires each State Party to 'take steps ... to the maximum of its available resources, with a view to achieving progressively the full realization' of this right 'by all appropriate means, including particularly the adoption of legislative measures'. 

 

The steps to be taken by States Parties to achieve full realisation of the right to health are specified in Article 12(2) and include:

*         steps necessary for 'the prevention, treatment and control of epidemic, endemic, occupational and other diseases' (Article 12(2)(c)); and

*         steps necessary for 'the creation of conditions which would assure to all medical service and medical attention in the event of sickness' (Article 12(2)(d)).

 

The provision of dental outreach services and the establishment of a mental health outreach clinic program to provide medical and dental services in rural and remote areas raise awareness of mental health issues or associated preventative activities, and the provision of emergency primary medical evacuation services will promote the right to health recognised in the ICESCR.  The rural and remote outreach services will improve the prevention and treatment of diseases in these areas and increase the accessibility of medical services. 

 

New table item 287 establishes legislative authority for the Government to provide funding to the KIDS Foundation for the SeeMore Safety Program (the Program).

 

The KIDS Foundation will use the funding to roll out the Program in up to 5,000 kindergartens and preschools in Victoria.  The Program is a safety education program for preschool and kindergarten classes that focuses on learning through literature and real life experiences.

 

The objectives of the Program are to:

*         reduce the number of preventable childhood injuries through the development of safety risk intelligence in children;

*         build self and safety understanding, and responsible practices;

*         prepare, sustain and educate children to manage safety throughout their lives; and

*         promote the prevention and control of the physiological after-effects and possible physical complications of childhood accidents.

 

Funding of $1 million was included in the 2018-19 Budget as part of the measure 'Healthy Active Beginnings' for a period of two years commencing in 2018-19.  Details are set out in Budget 2018-19, Budget Measures, Budget Paper No. 2 2018-19 at page 111.

 

The department will use a closed, non-competitive process to award a grant to the KIDS Foundation in accordance with applicable legislative requirements under the Public Governance, Performance and Accountability Act 2013 and the Commonwealth Grants Rules and Guidelines 2017

 

The KIDS Foundation's proposal will be assessed against the eligibility and assessment criteria in the grant guidelines, which will outline the objectives and outcomes of the government funding and the deliverables.  Following assessment of the proposal on its merit, the delegate of the Secretary of the department will make the final funding decision.  The Secretary's delegate will consider whether the proposal represents an efficient, effective, ethical and economical use of Commonwealth resources, and whether any specific requirements need to be imposed as a condition of funding. 

 

The decision of the Secretary's delegate is final in all matters including:

*         the approval of the grant;

*         the grant funding amount to be awarded; and

*         the terms and conditions of the grant. 

 

Information about the grant will be published on the departmental website at www.health.gov.au and on GrantConnect at www.grants.gov.au.

 

The provision of funds to the KIDS Foundation for the Program is not considered suitable for independent merits review because the expenditure is one-off, time-limited and non-competitive.  The direct source arrangement is considered appropriate because the KIDS Foundation holds the intellectual property rights for this internationally recognised and evidence-based injury prevention program.

 

Funding for this item will come from Program 2.4: Preventative Health and Chronic Disease, which is part of Outcome 2.  Details are set out in the Portfolio Budget Statements 2018-19, Budget Related Paper No. 1.9, Health Portfolio at pages 31 and 63.

 

Noting that it is not a comprehensive statement of relevant constitutional considerations, the objective of this item references the external affairs power (section 51(xxix)) of the Constitution. 

 

Section 51(xxix) of the Constitution empowers the Parliament to make laws with respect to 'external affairs'.  The external affairs power supports legislation implementing Australia's obligations under international treaties to which it is a party. 

 

Australia is a party to the Convention on the Rights of the Child (CRC).  Article 2(1) provides that States Parties shall 'respect and ensure the rights set forth in the present Convention to each child'.  In particular:

*         Article 6 of the CRC provides that States Parties recognise 'that every child has the inherent right to life' and shall 'ensure to the maximum extent possible the survival and development of the child' (Article 6(2));

*         Article 18(2) of the CRC provides that for the purpose of 'guaranteeing and promoting' the rights set out in the Convention, States Parties shall 'render appropriate assistance to parents and legal guardians in the performance of their child-rearing responsibilities';

*         Article 24(2) of the CRC includes obligations to take measures to 'diminish infant and child mortality' (Article 24(2)(a)) and to ensure that children 'are informed, have access to education and are supported in the use of basic knowledge of ... the prevention of accidents' (Article 24(2)(e)); and

*         Article 31(1) of the CRC recognises the right of the child 'to engage in play and recreational activities'. 

 

The Program is a safety education program for preschool and kindergarten classes that focuses on learning through literature and real life experiences.  The Program will assist parents and guardians in their child-rearing responsibilities by educating children about the prevention of accidents and encouraging children to engage in play and recreational activities safely.

 

New table item 288 establishes legislative authority for government spending on the development of resources and training to increase awareness amongst general practitioners (GPs) and other clinicians of the existence, presenting symptoms of spinal muscular atrophy and referral pathways, including genetic testing for patients at risk.

 

Spinal muscular atrophy is a rare inherited genetic muscle wasting disease that is characterised by a loss of nerve cells called motor neurons.  The loss of motor neurons causes progressive muscle weakness and wasting, leading to death.

 

GPs have an important role in developing and implementing appropriate care plans and case coordination.  A lack of knowledge about spinal muscular atrophy reduces a GP's ability to correctly identify spinal muscular atrophy as a potential cause for presenting symptoms.  Greater awareness of spinal muscular atrophy and its presentations will mean that GPs are in a better position to recognise potential symptoms and refer where appropriate.

 

Specific resources to be developed will include online training for GPs, videos for health professionals and parents with young children, and brochures for GPs to use themselves and to disseminate to patients as relevant.

 

Funding of $1 million was included in the 2018-19 Budget as part of the measure 'Healthy Active Beginnings' for a period of three years commencing in 2018-19.  Details are set out in Budget 2018-19, Budget Measures, Budget Paper No. 2 2018-19 at page 111.

 

The department will run an open tender to engage suitably qualified service provider/s to undertake a literature review and develop online training and resources for GPs.  The procurement process will take into consideration the prospective service providers' understanding of spinal muscular atrophy and the target audience. 

 

The selection criteria, against which applications from prospective service providers will be assessed, will be published in the procurement documentation.  This documentation will include a procurement plan, a probity plan and a risk assessment plan.  Applications from prospective service providers will be assessed by experienced departmental officials.  In accordance with the Commonwealth Procurement Rules, details of the procurement opportunity will be available on the AusTender website at www.tenders.gov.au.

Decisions in connection with the procurement process will be made by a delegate of the Secretary of the department in accordance with the Secretary Instructions and relevant financial delegations.  Information about successful tenderers will be published on AusTender. 

 

The department will use a limited tender to award funding to the Royal Australian College of General Practitioners (RACGP) for the accreditation and promotion of resources that are developed.  The resources and training will be promoted through the RACGP media channels such as their website.  Decisions in connection with this procurement process will be made by a delegate of the Secretary of the department in accordance with the Secretary Instructions and relevant financial delegations.  Information about the procurement will be published on AusTender.  

 

The department will also procure design, printing and storage services using existing departmental procurement and panel arrangements.  Decisions in connection with this procurement process will be made by a delegate of the Secretary of the department in accordance with the Secretary Instructions and relevant financial delegations.  Information about the procurement will be published on AusTender.

 

Decisions in connection with the expenditure of funds for the development and promotion of resources are not considered suitable for independent review because they relate to a short-term, time-limited project.  These decisions will be subject to the Commonwealth's resource management framework, including the Public Governance, Performance and Accountability Act 2013 and the Commonwealth Procurement Rules.

 

The provision of funds to the RACGP to administer, accredit and promote training is not considered suitable for independent merits review because the expenditure is time-limited and non-competitive.  The direct source arrangement is considered appropriate as the RACGP is the peak body for Australian GPs which has the capability and expertise required, and established infrastructure.  To reconsider this decision under merits review would substantially delay implementation in a market environment where there are no alternative providers with similar capacity to access Australian GPs.

 

Funding for this item will come from Program 2.4: Preventative Health and Chronic Disease, which is part of Outcome 2.  Details are set out in the Portfolio Budget Statements 2018-19, Budget Related Paper No. 1.9, Health Portfolio at pages 31 and 63.

 

Noting that it is not a comprehensive statement of relevant constitutional considerations, the objective of the item references the following powers of the Constitution:

*         the communications power (section 51(v));

*         the external affairs power (section 51(xxix)); and

*         the social welfare power (section 51(xxiiiA)).


 

Communications power

 

Under section 51(v) of the Constitution, the Commonwealth has the power to legislate with respect to 'postal, telegraphic, telephonic, and other like services'. 

 

Funding will be provided to support activities that involve the dissemination of information via a relevant communications service, including the preparation of relevant materials to be disseminated.  This may include educational and training materials being provided online and the development and delivery of these materials.

 

External affairs power

 

Under section 51(xxix) of the Constitution, the Commonwealth has the power to legislate with respect to 'external affairs'.

 

Funding will be provided to develop and deliver educational materials and campaigns to inform the public and GPs about health conditions affecting infants (spinal muscular atrophy) in order to improve the likelihood of diagnosis and resulting treatment outcomes. 

 

This funding is adapted to implementing the obligations in Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights [1976] ATS 5 (ICESCR).  Article 12(1) of the ICESCR recognises the 'right of everyone to the enjoyment of the highest attainable standard of physical and mental health'.  Article 2 requires each State Party to 'take steps ... to the maximum of its available resources, with a view to achieving progressively the full realization' of this right 'by all appropriate means, including particularly the adoption of legislative measures'.

 

The steps to be taken by States Parties to achieve full realisation of the right to health care are specified in Article 12(2) and include steps necessary for 'the creation of conditions which would assure to all medical service and medical attention in the event of sickness'.

 

The right to health is also recognised in the Convention on the Rights of the Child [1991] ATS 4 to which Australia is a party.  Article 24 provides that States Parties 'recognize the right of the child to the enjoyment of the highest attainable standard of health'.  Article 4 requires States Parties to 'undertake all appropriate legislative, administrative and other measures for the implementation of the rights' recognised in the Convention.  Funding will be provided to educate primary health care providers to improve the likelihood of infants with spinal muscular atrophy being diagnosed and treated. 

 

Social welfare power

 

Under section 51(xxiiiA) of the Constitution, the Commonwealth has the power to legislate with respect to 'the provision of maternity allowances, widows' pensions, child endowment, unemployment, pharmaceutical, sickness and hospital benefits, medical and dental services (but not so as to authorize any form of civil conscription), benefits to students and family allowances'.

 

In relation to the medical services aspect of the social welfare power, funding will be provided to the RACGP (or some other body) to develop and deliver the proposed materials, training and education campaign, which will increase the likelihood of diagnosis and treatment for persons with spinal muscular atrophy.

 

New table item 289 establishes legislative authority for government spending on the development of resources to increase awareness amongst general practitioners (GPs) and other clinicians of the existence, presenting symptoms and possible treatments of endometriosis. 

 

Endometriosis is a condition where the endometrium (lining of the womb) migrates to other parts of a woman's body (for example, bowel or bladder) resulting in significant pain and discomfort.  One in ten women suffer from endometriosis, however, diagnosis of the condition is currently taking up to 10 years.

 

Funding of $1 million was included in the 2018-19 Budget as part of the measure 'Healthy Active Beginnings' for a period of three years commencing in 2018-19.  Details are set out in Budget 2018-19, Budget Measures, Budget Paper No. 2 2018-19 at page 111.

 

The department will run an open tender to engage suitably qualified service provider/s to undertake a literature review and develop online training for GPs and educational materials including resources for practitioners to distribute to patients as relevant.  The procurement process will take into consideration the prospective service providers' understanding of endometriosis and the target audience. 

 

The selection criteria, against which applications from prospective service providers will be assessed, will be published in the procurement documentation.  This documentation will include a procurement plan, a probity plan and a risk assessment plan.  Applications from prospective service providers will be assessed by experienced departmental officials.  In accordance with the Commonwealth Procurement Rules, details of the procurement opportunity will be available on the AusTender website at www.tenders.gov.auDecisions in connection with this procurement process will be made by a delegate of the Secretary of the department in accordance with the Secretary Instructions and relevant financial delegations.  Information about successful tenderers will be published on AusTender. 

 

The department will use a limited tender to award funding to the Royal Australian College of General Practitioners (RACGP) and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) for the accreditation and promotion of resources that are developed.  Decisions in connection with this procurement process will be made by a delegate of the Secretary of the department in accordance with the Secretary Instructions and relevant financial delegations.  In accordance with the Commonwealth Procurement Rules, details of the procurement will be available on the AusTender website at www.tenders.gov.au.

 

The department will also procure design, printing and storage services using existing departmental procurement and panel arrangements.  Decisions in connection with this procurement process will be made by a delegate of the Secretary of the department in accordance with the Secretary Instructions and relevant financial delegations.  In accordance with the Commonwealth Procurement Rules, details of the procurement will be available on the AusTender website at www.tenders.gov.au

 

Decisions in connection with the expenditure of funds for the development and promotion of resources are not considered suitable for independent review because they relate to a short-term, time-limited project.  These decisions will be subject to the Commonwealth's resource management framework, including the Public Governance, Performance and Accountability Act 2013 and the Commonwealth Procurement Rules.

 

The provision of funds to the RACGP and the RANZCOG to administer, accredit and promote training is not considered suitable for independent merits review because the expenditure is time-limited and non-competitive.  The direct source arrangement is considered appropriate because the RACGP is the peak body for Australian GPs, and the RANZCOG is the peak body for obstetricians and gynaecologists.  The RACGP and the RANZCOG have the appropriate capability, the specific expertise required and established infrastructure.  To reconsider this decision under merits review would substantially delay implementation in a market environment where there are no alternative providers with similar capacity to access Australian GPs, obstetricians and gynaecologists.

 

Funding for this item will come from Program 2.4: Preventative Health and Chronic Disease, which is part of Outcome 2.  Details are set out in the Portfolio Budget Statements 2018-19, Budget Related Paper No. 1.9, Health Portfolio at pages 31 and 63.

 

Noting that it is not a comprehensive statement of relevant constitutional considerations, the objective of the item references the following powers of the Constitution:

*         the communications power (section 51(v));

*         the external affairs power (section 51(xxix)); and

*         the social welfare power (section 51(xxiiiA)).

 

Communications power

 

Section 51(v) of the Constitution empowers the Parliament to make laws with respect to 'postal, telegraphic, telephonic and other like services'.

 

Funding will be provided for the preparation and delivery of educational and training materials which will be available online.

 

External affairs power

 

Section 51(xxix) of the Constitution empowers the Parliament to make laws with respect to 'external affairs'.  The external affairs power supports legislation implementing Australia's obligations under international treaties to which it is a party. 

 

Australia is a party to the Convention on the Elimination of All Forms of Discrimination against Women.  Article 12 provides that States Parties 'shall take all appropriate measures to eliminate discrimination against women in the field of health care'.  Article 11 requires States Parties to take steps to protect 'the right to protection of health ... including the safeguarding of the function of reproduction' (Article 11(1)(f)).  The expenditure will counter discrimination against women in health care by increasing awareness and improving outcomes in relation to a condition affecting women, and protect women's reproductive health, which may be negatively impacted by endometriosis.

 

The right to health is also recognised in the Convention on the Rights of the Child to which Australia is a party.  Article 24 provides that States Parties 'recognize the right of the child to the enjoyment of the highest attainable standard of health'.  Article 4 requires States Parties to 'undertake all appropriate legislative, administrative and other measures for the implementation of the rights' recognised in the Convention.  The expenditure will improve the diagnosis and treatment of adolescent girls with endometriosis.

 

Additionally, Australia is a party to the International Covenant on Economic, Social and Cultural Rights (ICESCR).  Article 12(1) of the ICESCR recognises the 'right of everyone to the enjoyment of the highest attainable standard of physical and mental health'.  Article 2 requires each State Party to 'take steps ... to the maximum of its available resources, with a view to achieving progressively the full realization' of this right 'by all appropriate means, including particularly the adoption of legislative measures'.

 

The steps to be taken by States Parties to achieve full realisation of the right to health are specified in Article 12(2) and include:

*         steps necessary for 'the prevention, treatment and control of epidemic, endemic, occupational and other diseases' (Article 12(2)(c)); and

*         steps necessary for 'the creation of conditions which would assure to all medical service and medical attention in the event of sickness' (Article 12(2)(d)). 

 

The expenditure involves developing and delivering educational materials to inform GPs about a health condition affecting women (endometriosis), in order to improve the likelihood of diagnosis and resulting treatment outcomes.  The expenditure will improve access to treatment for endometriosis by increasing both the population's awareness of the condition and the available health services to treat endometriosis. 

 

Social welfare power

 

The social welfare power in section 51(xxiiiA) of the Constitution empowers the Parliament to make laws with respect to the provision of various social welfare services including medical services.

 

Funding the RACGP and the RANZCOG (or some other body) to deliver the proposed materials, training and education campaigns, will improve the quality and effectiveness of Commonwealth funded 'medical services', by increasing awareness among medical professionals and the public of endometriosis and promoting early diagnosis and treatment. 

 

New table item 290 establishes legislative authority for government spending on the development of educational materials to encourage women with gestational diabetes mellitus to undergo testing for future risk of type 2 diabetes.

 

Gestational diabetes mellitus and type 2 diabetes rates are increasing in Australia.  Women with previous gestational diabetes mellitus are more likely to develop type 2 diabetes within the next five years.  The children of mothers with gestational diabetes mellitus are eight times more likely to develop pre-diabetes and diabetes when they are 19 to 27 years old.  Early detection of diabetes is important to reduce the occurrence of diabetes related complications and improve quality of life.


 

Funding will be provided:

*         to develop and disseminate educational materials to women with gestational diabetes mellitus through their health care provider to encourage follow-up testing for the future risk of type 2 diabetes at critical time points (six weeks and 12 months after birth).  Educational materials will be tailored for priority groups, as identified in the Australian National Diabetes Strategy 2016-2020 (translated where required), and supported by a mobile application targeted at women who have gestational diabetes and are on the National Diabetes Register; and

*         to undertake research that explores new models and barriers to effectively engage women, who have had gestational diabetes mellitus, for follow-up testing for type 2 diabetes.

 

The Australian National Diabetes Strategy 2016-2020 is available at www.health.gov.au/internet/main/publishing.nsf/Content/nds-2016-2020.

 

Funding of $0.6 million was included in the 2018-19 Budget as part of the measure 'Healthy Active Beginnings' for a period of three years commencing in 2018-19.  Details are set out in Budget 2018-19, Budget Measures, Budget Paper No. 2 2018-19 at page 111.

 

The department will run an open competitive tender to engage suitably qualified service providers to:

*         undertake research;

*         develop required resources which will be disseminated by the department;

*         translate developed resources as required; and

*         develop and deliver a mobile application. 

 

The selection criteria, against which applications from prospective service providers will be assessed, will be published in the procurement documentation.  This documentation will include a procurement plan, a probity plan and a risk assessment plan.  Applications from prospective service providers will be assessed by experienced departmental officials. 

In accordance with the Commonwealth Procurement Rules, details of the procurement opportunity will be available on the AusTender website at www.tenders.gov.au.  Decisions in connection with the procurement will be made by a delegate of the Secretary of the department in accordance with the Secretary Instructions and relevant financial delegations.  Information about successful tenderers will be published on AusTender. 

 

Decisions in connection with the procurement are not considered suitable for independent review because they relate to a short-term, time-limited project.  These decisions will be subject to the Commonwealth's resource management framework, including the Public Governance, Performance and Accountability Act 2013 and the Commonwealth Procurement Rules.

 

Funding for this item will come from Program 2.4: Preventative Health and Chronic Disease, which is part of Outcome 2.  Details are set out in the Portfolio Budget Statements 2018-19, Budget Related Paper No. 1.9, Health Portfolio at pages 31 and 63.

 

Noting that it is not a comprehensive statement of relevant constitutional considerations, the objective of the item references the following powers of the Constitution:

*         the communications power (section 51(v));

*         the external affairs power (section 51(xxix)); and

*         the social welfare power (section 51(xxiiiA)). 

 

Communications power

 

Section 51(v) of the Constitution empowers the Parliament to make laws with respect to 'postal, telegraphic, telephonic, and other like services'. 

 

Funding will be provided to support activities to deliver materials online or through a mobile telephone service.  This may include the development of a mobile application to support educational materials being provided to health practitioners and their patients.

 

External affairs power

 

Section 51(xxix) of the Constitution empowers the Parliament to make laws with respect to 'external affairs'.  The external affairs power supports legislation implementing Australia's obligations under international treaties to which it is a party.

 

Australia is a party to the International Covenant on Economic, Social and Cultural Rights (ICESCR).  Article 12(1) of the ICESCR recognises the 'right of everyone to the enjoyment of the highest attainable standard of physical and mental health'.  Article 2 requires each State Party to 'take steps ... to the maximum of its available resources, with a view to achieving progressively the full realization' of this right 'by all appropriate means, including particularly the adoption of legislative measures'. 

 

The steps to be taken by States Parties to achieve full realisation of the right to health are specified in Article 12(2) and include steps necessary for 'the prevention, treatment and control of epidemic, endemic, occupational and other diseases' (Article 12(2)(c)). 

 

The development and delivery of educational materials to encourage women with gestational diabetes mellitus to undergo testing for future risk of type 2 diabetes is directed at raising awareness of this risk and ensuring that women at risk receive the necessary care.  This will promote the prevention, treatment and control of the disease. 

 

Social welfare power

 

The social welfare power in section 51(xxiiiA) of the Constitution empowers the Parliament to make laws with respect to the provision of various social welfare services including 'medical services'.

 

Funding will be provided to promote activities (diabetes testing) that would facilitate the early detection of type 2 diabetes, and thereby reduce the incidence of diabetes related complications and the need for Commonwealth funded medical services in the target group.

 

New table item 291 establishes legislative authority for government spending on the development of resources and educational materials for pregnant women in relation to managing weight, improving dietary habits and increasing physical activity, and research to inform the development of safe pregnancy physical activity guidelines.


 

Funding will be provided:

*         to develop and disseminate educational materials to women who are pregnant, planning a pregnancy or who have just had a baby;

*         to undertake research that will inform the development of safe pregnancy physical activity guidelines; and

*         to disseminate and promote the safe pregnancy physical activity guidelines that are developed.

 

The materials will leverage the existing evidence base and will support and promote improvements to physical activity levels and dietary intakes to avoid increased weight gain and the complications associated with obesity such as type 2 diabetes and cardiovascular disease.  Existing government funded programs (for example, Health Direct and Raising Children Network) and social media will be utilised to disseminate relevant information, promote resources and target women before, during and immediately following pregnancy. 

 

Health Direct is a national, government-owned, not-for-profit organisation which provides a range of different information and advice services to help Australians manage their health and wellbeing.  The Raising Children Network provides evidence-based, scientifically validated information and practical advice about raising children to parents.  Both programs reach a wide audience, including pregnant women, who would benefit from the information provided by this campaign.  By partnering with Health Direct and the Raising Children Network, this initiative will maximise its reach and can avoid duplication of existing information.

 

Funding of $3 million was included in the 2018-19 Budget as part of the measure 'Healthy Active Beginnings' for a period of four years commencing in 2018-19.  Details are set out in Budget 2018-19, Budget Measures, Budget Paper No. 2 2018-19 at page 111.

 

The department will procure the majority of the services for the development of the pregnancy resources, including the safe pregnancy physical activity guidelines, and communication strategy using existing departmental procurement and panel arrangements and, if required, through an open or limited tender.

 

The procurement will take into consideration the prospective service providers' understanding of the requirements and the target audience (primarily pregnant women).  The selection criteria, against which applications from prospective service providers will be assessed, will be published in the procurement documentation.  This documentation will include a procurement plan, a probity plan and a risk assessment plan.  In accordance with the Commonwealth Procurement Rules, details of the procurement opportunity will be available on the AusTender website at www.tenders.gov.au.

 

Applications from all prospective service providers (through both open and limited tenders) will be assessed by experienced departmental officials.  Decisions in connection with the procurement will be made by a delegate of the Secretary of the department in accordance with the Secretary Instructions and relevant financial delegations.  Where applicable procurement thresholds are met, these decisions will be published on AusTender.

 

Decisions in connection with the procurement are not considered suitable for independent review because they relate to a short-term, time-limited project.  These decisions will be subject to the Commonwealth's resource management framework, including the Public Governance, Performance and Accountability Act 2013 and the Commonwealth Procurement Rules.

 

Funding for this item will come from Program 2.4: Preventative Health and Chronic Disease, which is part of Outcome 2.  Details are set out in the Portfolio Budget Statements 2018-19, Budget Related Paper No. 1.9, Health Portfolio at pages 31 and 63.

 

Noting that it is not a comprehensive statement of relevant constitutional considerations, the objective of the item references the following powers of the Constitution:

*         the communications power (section 51(v));

*         the external affairs power (section 51(xxix)); and

*         the Commonwealth executive power and the express incidental power (sections 51(xxxix) and 61), including the nationhood aspect. 

 

Communications power

 

Section 51(v) of the Constitution empowers the Parliament to make laws with respect to 'postal, telegraphic, telephonic and other like services'.

 

Funding will be provided to develop, deliver and promote health information for pregnant women online through social media.

 

External affairs power

 

Section 51(xxix) of the Constitution empowers the Parliament to make laws with respect to 'external affairs'.  The external affairs power supports legislation implementing Australia's obligations under international treaties to which it is a party. 

 

Australia is a party to the International Covenant on Economic, Social and Cultural Rights (ICESCR).  Article 12(1) of the ICESCR recognises the 'right of everyone to the enjoyment of the highest attainable standard of physical and mental health'.  Article 2 requires each State Party to 'take steps ... to the maximum of its available resources, with a view to achieving progressively the full realization' of this right 'by all appropriate means, including particularly the adoption of legislative measures'.

 

The steps to be taken by States Parties to achieve full realisation of the right to health are specified in Article 12(2) and include steps necessary for 'the prevention, treatment and control of epidemic, endemic, occupational and other diseases' (Article 12(2)(c)). 

 

The proposed development, dissemination and promotion of educational materials for pregnant women is directed at promoting a healthy weight, healthy eating, and an appropriate level of physical activity among pregnant Australian women, with a view to reducing rates of chronic health conditions and pregnancy complications. 

 

In addition, the expenditure on medical research to inform the development of physical activity guidelines for pregnancy, with a view to disseminating that information to the public, will promote the prevention of diseases.


 

Commonwealth executive power and express incidental power, including the nationhood aspect

 

The express incidental power (section 51(xxxix) of the Constitution) empowers the Parliament to make laws with respect to matters incidental to the execution of any power vested in it by the Constitution.  Together with the executive power (section 61 of the Constitution), section 51(xxxix) supports activities that are peculiarly adapted to the government of a nation and cannot be carried out for the benefit of the nation otherwise than by the Commonwealth. 

 

The expenditure on medical research in connection with developing physical activity guidelines for pregnancy reflects the Government's commitment to inquiring, investigating and advocating for public health matters of national importance. 

 

New table item 292 establishes legislative authority for government spending on health infrastructure projects in regional, rural and remote areas in Australia that will improve regional and remote health outcomes through better access to health infrastructure.

 

The Government will provide funding to support the delivery of health infrastructure to address specific regional and remote health infrastructure needs.  Investment in new and extended health care facilities will provide much needed infrastructure for the communities to access better and timelier care, delivered closer to home.  This will support earlier diagnoses and treatment of illnesses, better management of chronic conditions and improved health outcomes in regional and remote regions of Australia.

 

The projects will be broadly consistent with the objectives of the former Health and Hospital Fund (HHF) Program established in 2008-09, addressing community health infrastructure needs in regional and remote areas and delivering comparable project outcomes.  The HHF objectives, while not replacing state and territory effort, were to:

*         invest in major infrastructure programs that would make significant progress towards achieving the Commonwealth's health reform targets; and

*         make strategic investments in the health system that would underpin major improvements in efficiency, access or outcomes of health care.

 

This program will enable existing HHF projects to be re-scoped or the funding recipient to be changed to enable the successful delivery of the proposed infrastructure projects.  Currently, the following five HHF projects will be revised and completed under this program: 

*         South Eastern NSW Health Collaborative Development (Phase 2) - establishing hubs to house and co-locate clinical service providers, and to provide consulting facilities working with local primary health care providers;

·         Katherine Clinical Training Academic Health Centre Development - establishing a clinical training facility and short-term student and staff accommodation; 

*         Cape York development of primary health care services - constructing five separate primary health care facilities and associated accommodation; 

*         Halls Creek Medical Centre Redevelopment - renovating and extending the existing Yura Yungi Medical Service facility at Halls Creek; and

*         Ringer Soak Yura Yungi Medical Service Clinic Redevelopment - upgrading of facilities at the Ringer Soak community health clinic. 


 

Funded activities may include the purchase, construction or redevelopment of:

*         clinical training facilities;

*         student and staff accommodation; and/or

*         primary and community health care facilities and associated accommodation.

 

Funding for this item will come from Program 1.3: Health Infrastructure, which is part of Outcome 1.  Details are set out in the Portfolio Budget Statements 2018-19, Budget Related Paper No. 1.9, Health Portfolio at page 48.

 

For existing funding recipients, there will be no grant process undertaken, with the department intending to revise existing funding agreements with non-government organisations (NGOs) to complete the infrastructure projects.  Where alternative projects are unable to continue to be managed by NGOs, the department will have an ability to novate the agreement to an alternative funding recipient through an appropriate grant process to ensure continuity of the project through to completion. 

 

In instances where the current funding recipient is no longer appropriate or an appropriate alternative NGO is unavailable, the department will test whether the relevant state or territory government would be willing to assume responsibility for the projects where this is the only option to deliver the required infrastructure in these rural and remote communities. 

 

The department may use open competitive, targeted or restricted competitive or closed non-competitive processes to award grants under the program.  All grant processes will be undertaken in accordance with the Commonwealth Grants Rules and Guidelines 2017.

 

The department will establish an assessment committee to assess applications and make recommendations to the approver.  The assessment committee will be comprised of representatives of the program division, specialist grant application assessors and grant managers.  The assessment committee may also seek input from external advisers to inform the assessment process. 

 

The approver will consider whether the proposal will make an efficient, effective, ethical and economical use of Commonwealth resources, as required by Commonwealth legislation, and whether any specific requirements will need to be imposed as a condition of funding. 

The approver as a delegate of the Secretary of the department will have the authority to approve:

*         the revision of existing funding agreements;

*         entering into new agreements with NGOs; and

*         entering into new agreements with states and/or territories.

 

Decisions made in connection with the revised projects with existing funding recipients will not be subject to independent review.  The community need for the health infrastructure and provision of services facilitated by the associated grants were previously assessed and approved by the independent former HHF Advisory Board.  Revised projects will continue to be broadly consistent with the objectives of the HHF Program and deliver comparable project outcomes.

 

Decisions made in connection with providing project funding to states and/or territories will not be subject to independent review as they relate to projects where this is the only option to deliver the required infrastructure in the affected rural and remote communities.

 

Decisions in relation to new funding recipients may be subject to a merits review process.  Final details will be included in the grant application pack released at the time of the grant round.  If a grant application is unsuccessful, the applicant can request feedback or a debrief on their application. 

 

If a grant applicant is not satisfied that their application was assessed correctly, the applicant will be able to access a merits review process.  This will involve a formal review of the application against the program guidelines and the requirements of the grant application pack.  This process will be undertaken by a departmental officer who was not the original primary decision-maker and who will reconsider the facts, law and aspects of the original decision, and determine whether the decision settled upon was the best that could have been made on the basis of relevant facts. 

 

Noting that it is not a comprehensive statement of relevant constitutional considerations, the objective of the item references the following powers of the Constitution:

*         the races power (section 51(xxvi));

*         the external affairs power (section 51(xxix));

*         the power to grant financial assistance to States (section 96); and

*         the territories power (section 122).

 

Races power

 

Section 51(xxvi) of the Constitution empowers the Parliament to make laws with respect to 'the people of any race for whom it is deemed necessary to make special laws'.  The races power supports legislation with respect to Indigenous Australians. 

 

Under the Cape York development of primary health care services QLD (Cape York Project), Halls Creek Medical Centre Redevelopment WA (Halls Creek Project) and Ringer Soak Yura Yungi Medical Service Clinic Redevelopment WA (Ringer Soak Project), funding will be directed, in part, to an Aboriginal Community Controlled Health Organisation to provide medical facilities and services particularly to Indigenous communities. 

 

External affairs power

 

Section 51(xxix) of the Constitution empowers the Parliament to make laws with respect to 'external affairs'.  The external affairs power supports legislation implementing Australia's obligations under international treaties to which it is a party. 

 

Australia is a party to the International Covenant on Economic, Social and Cultural Rights (ICESCR).  Article 12(1) of the ICESCR recognises the 'right of everyone to the enjoyment of the highest attainable standard of physical and mental health'.  Article 2 requires each State Party to 'take steps ... to the maximum of its available resources, with a view to achieving progressively the full realization' of this right 'by all appropriate means, including particularly the adoption of legislative measures'. 

 

The steps to be taken by States Parties to achieve full realisation of the right to health are specified in Article 12(2) and include:

*         steps necessary for 'the provision for the reduction of the still-birth rate and of infant mortality and for the health development of the child' (Article 12(2)(a));

*         steps necessary for 'the prevention, treatment and control of epidemic, endemic, occupational and other diseases' (Article 12(2)(c)); and

*         steps necessary for 'the creation of conditions which would assure to all medical service and medical attention in the event of sickness' (Article 12(2)(d)). 

 

Additionally, Australia is a party to the International Convention on the Elimination of All Forms of Racial Discrimination (CERD).  Article 2 of the CERD requires that States Parties undertake to prohibit and eliminate racial discrimination in all of its forms and to guarantee the right of everyone, without distinction as to race, to equality before the law.  Article 5(e)(iv) requires States Parties to 'guarantee the right of everyone, without distinction as to race', 'the right to public health, medical care, social security and social services'.

 

The provision of grants for health infrastructure projects in regional and remote locations in Australia will ensure Australia upholds its obligations under the ICESCR and the CERD.  Improving the functioning and availability of public health and health care facilities, goods and services in regional and remote locations in Australia will improve the quality and accessibility of those services, especially for vulnerable or marginalised groups such as Indigenous communities in these areas. 

 

Financial assistance to States

 

Section 96 of the Constitution empowers the Parliament to 'grant financial assistance to any State on such terms and conditions as the Parliament thinks fit'. 

 

The department may decide to fund the infrastructure projects by making grants to States. 

 

Territories power

 

Section 122 of the Constitution empowers the Parliament to make laws 'for the government of any territory'.

 

Funding will be provided for the Katherine Clinical Training Academic Health Centre Development (Katherine Project) in the Northern Territory.  The department may decide to fund the infrastructure projects by making grants to Territories.

 

New table item 293 establishes legislative authority for government spending on:

*         educational activities to increase the use of biosimilar medicines;

*         enhancements to software to increase the use of generic and biosimilar medicines and improve electronic prescribing and dispensing arrangements; and

*         software changes to improve the management of controlled drugs, including changes to the IT system for the Electronic Reporting and Recording of Controlled Drugs system and the development of a Real Time Prescription Monitoring system.


 

Biosimilar education

 

The Government is providing a grant of $5 million over four years from 2017-18 to GBMA Education Limited (GBMA Education) for educational activities related to biosimilar brands of biological medicines.  GBMA Education is a company established by the Generic and Biosimilar Medicines Association (GBMA).

 

Biological medicines contain substances that are derived from living cells or organisms.  A biosimilar medicine is a highly similar version of a registered biological medicine (a reference biological medicine), which is the first brand to market.  Biosimilar medicines are generally brought to market after the patent expires for the reference biological medicine and are marketed under different brand names. 

 

The objective of this initiative is to increase confidence in the use of biosimilar medicines which are listed on the Pharmaceutical Benefits Scheme (PBS).  This will result in multiple viable brands in the market and provide:

*         cost savings to the PBS which can be reinvested in the health system - savings will flow from market competition on prices and related reductions in the PBS subsidised prices;

*         protection against medicine shortages which are an increasing issue worldwide; and

*         increased prescriber and consumer choice.

 

GBMA Education will use grant funding to support the following activities:

*         identifying and supporting experts to provide evidence-based, factual information about biological medicines, particularly biosimilar medicines, to health care providers and consumers (for example, organising conferences, seminars, forums, meetings and webinars, or supporting expert attendance at events organised by others);

*         developing and disseminating materials and resources about biological medicines, particularly biosimilar medicines, through print and electronic communications to health care providers and consumers (for example, fact sheets, guidelines, journal articles, newsletters, videos, and social media materials);

*         developing continuing professional development online resources and events related to biological medicines, particularly biosimilar medicines, for health care providers; and

*         undertaking evaluation and reporting on the impact of education and the uptake of biosimilar medicines, including their acceptance and use (for example, market research on penetration of educational activities, data collection, analysis and reporting).

 

GBMA Education will work collaboratively with other stakeholders, including other peak bodies for pharmaceutical companies, peak bodies for clinician prescribers, pharmacists, consumers, and specialist quality use of medicines education providers.  GBMA Education will deliver grant funded activities together with other providers (for example, clinical and scientific experts, specialist medical writers, medicines education providers, and online content developers). 

 

Funding for educational activities related to biosimilar medicines is being provided to  GBMA Education by way of a non-competitive, one-off, targeted grant.  The grant process, including the development of grant guidelines, has been conducted in accordance with the Commonwealth Grants Rules and Guidelines 2017.  The grant will be administered by the department through the Community Grants Hub.  Funding decisions are made by a delegate of the Secretary of the department.  The grant decision is published on GrantConnect (www.grants.gov.au) and the grant guidelines are available at www.health.gov.au/biosimilars.

 

Decisions made in connection with funding for educational activities related to biosimilar medicines will not be subject to independent review as the grant is one-off, targeted, non-competitive and for a specific purpose.

 

GBMA Education, the grant recipient, is a company related to the GBMA, the peak industry organisation for the makers of generic and biosimilar medicines.  An existing alignment between the GBMA's activities and the Government's initiatives relating to biosimilar medicines, along with the GBMA's capacity to draw on an international and domestic network of scientists and clinicians, its understanding of the relevant industry environment in Australia, and its ability to lead collaboration among industry and other stakeholders to provide evidence-based, factual educational activities, make GBMA Education an appropriate provider of educational activities related to biosimilar medicines. 

 

Funding for this initiative was included in the 2018-19 Budget under the measure 'Improving Access to Medicines - encouraging greater use of generic and biosimilar medicines'.  Details are set out in Budget 2018-19, Budget Measures, Budget Paper No. 2 2018-19 at page 113.

 

Funding for this item will come from Program 4.3: Pharmaceutical Benefits, which is part of Outcome 4.  Details are set out in the Portfolio Budget Statements 2018-19, Budget Related Paper No. 1.9, Health Portfolio at pages 36 and 93.

 

Electronic prescribing

 

The Government will provide funding of $28.2 million over five years from 2017-18 for enhancements to software to:

*         increase the use of generic and biosimilar brands of medicines, providing cost savings to the PBS which can be reinvested in the health system; and

*         improve the overall health of Australians through better and more cost-efficient electronic prescribing and dispensing arrangements for medicines.

 

This objective will be achieved through changes to prescribing software to allow medicines to be prescribed by ingredient name, without impinging on the professional judgement of clinicians to choose a particular brand if considered necessary.  This will contribute to increasing the uptake of generic and biosimilar medicine brands because the decision about which brand to prescribe and dispense will be less dependent on brand name loyalty and more related to choice of treatment and market conditions.  Changes to prescribing software will apply to most medicines listed on the PBS, although they may be applied in a staged manner. 

 

Funding will be provided for the following electronic prescribing enhancement activities, including: 

*         software and prescription management changes so that access to medicines can be managed electronically from prescription through to dispensing and claiming, including seamless management of repeat prescriptions that may be filled through different pharmacies.  Commonwealth regulations, including the National Health (Pharmaceutical Benefits) Regulations 2017 and the National Health (Claims and under co-payment data) Rules 2012, will be modified to support the operation of this end-to-end electronic prescribing process which will need to be reflected in the software systems;

*         software changes to improve medicine safety and quality prescribing by providing prescribers with additional information about available cost-effective medicine options and dispensed medicines;

*         software changes to enhance the management of the availability of medicines, pharmacovigilance (the detection, assessment, understanding and prevention of adverse effects or any drug related problem) and medicine safety reporting (for example, reporting of adverse medicine events), and the PBS compliance (for example, compliance with the PBS listing conditions); and

*         software changes to ensure the capture of additional information about prescribed and dispensed medicines for policy development and evaluation in relation to existing and potential PBS listings.  Commonwealth regulations, including the National Health (Claims and under co-payment data) Rules 2012, will be modified to support the data collection which will need to be reflected in the software systems.

 

Funding for these software enhancements was included in the 2018-19 Budget under the measure 'Improving Access to Medicines - e-prescribing for safer medicines'.  Details are set out in Budget 2018-19, Budget Measures, Budget Paper No. 2 2018-19 at pages 112 to 113.

 

Funding for this item will come from Program 4.3: Pharmaceutical Benefits, which is part of Outcome 4.  Details are set out in the Portfolio Budget Statements 2018-19, Budget Related Paper No. 1.9, Health Portfolio at pages 36 and 93.

 

Management of controlled drugs

 

Funding of $16.4 million over five years from 2016-17 is also being provided for software changes to the IT system for the Electronic Reporting and Recording of Controlled Drugs system and the development of a Real Time Prescription Monitoring system.  These systems will be integrated with prescribing and dispensing software to support the safe management and supply of controlled drugs (drugs of dependence or addiction which have certain restrictions placed on their availability due to the risk of harm to the patient from dependence, misuse or abuse). 

 

The states and territories regulate the use of controlled drugs.  However, there is a commitment at the Commonwealth level through the Australian Health Ministers' Advisory Council (the advisory and support body to the Council of Australian Governments (COAG) Health Council) to provide coordination to support nationally integrated, real-time monitoring of controlled drug use.  The Advisory Council has endorsed formal governance arrangements, including mechanisms to manage ongoing activities.  All governments are working on an agreed national approach, including funding responsibilities under the agreed governance arrangements. 

 

The Commonwealth funding is expected to cover the costs of maintaining national consistency in systems, supporting national governance arrangements, and further enhancements for real-time prescription monitoring, particularly the capacity to integrate with prescribing and dispensing software.  The states and territories are likely to make changes to their regulatory arrangements for the management of controlled drugs that will need to be reflected in the software systems.

 

Funding for the management of controlled drugs was included in the 2017-18 Mid-Year Economic and Fiscal Outlook under the measure 'National Approach to Prescription Drug Misuse'.  Details are set out in the Mid-Year Economic and Fiscal Outlook 2017-18, Appendix A: Policy decisions taken since the 2017-18 Budget at page 162.  A component of the funding for the management of controlled drugs is a Special Purpose Payment administered through the Department of the Treasury. 

 

Funding for this item will come from Program 4.3: Pharmaceutical Benefits, which is part of Outcome 4.  Details are set out in the Portfolio Additional Estimates Statements 2017-18, Health Portfolio at pages 19 and 47.

 

Funding to support electronic prescribing activities, including controlled drug monitoring, will be provided to organisations that manage electronic prescriptions, the Medical Software Industry Association, and software developers and vendors.  The funding includes payment to the states and territories to make changes to their regulatory arrangements for the management of controlled drugs.  The Commonwealth will be responsible for the delivery of electronic prescribing documentation such as specifications and vendor resource documents.  Specific changes to existing software systems will be the responsibility of individual vendors. 

 

Funding for electronic prescribing activities, including controlled drug monitoring, will be provided through multiple and varied procurement processes.  Procurements will be conducted as either open, limited or direct tenders and will be administered by the department in accordance with the Commonwealth Procurement Rules.  Where required, information about procurement opportunities will be published on the AusTender website at www.tenders.gov.au.

 

Funding decisions will be made by a delegate of the Secretary of the department.  All vendors will be advised directly whether they have been successful in the procurement process.  Contracts, once executed, will be reported on AusTender. 

 

Funding decisions made in connection with electronic prescribing activities, including controlled drug monitoring, will not be subject to independent review as they relate to procurement activities which are subject to the requirements of the Commonwealth's resource management framework, including the Public Governance, Performance and Accountability Act 2013 and the Commonwealth Procurement Rules.  Participants or tenderers will be selected on the basis of technical expertise, capability and value for money. 

 

Noting that it is not a comprehensive statement of relevant constitutional considerations, the objective of the item references the following powers of the Constitution:

*         the communications power (section 51(v));

*         the social welfare power (section 51(xxiiiA));

*         the external affairs power (section 51(xxix)); and

*         the Commonwealth executive power (section 61). 


 

Communications power

 

Under section 51(v) of the Constitution, the Commonwealth has power to legislate with respect to 'postal, telegraphic, telephonic and other like services'.

 

The program will provide funding to develop educational materials about generic and biosimilar medicines and electronic prescribing software, which will operate through, or rely on, electronic communications services such as the internet.

 

Social welfare power

 

Section 51(xxiiiA) of the Constitution empowers the Parliament to make laws with respect to the provision of various social welfare benefits and services, including pharmaceutical benefits.

 

The expenditure will support the uptake of generic and biosimilar medicines through the PBS.

 

External affairs power

 

Section 51(xxix) of the Constitution empowers the Parliament to make laws with respect to 'external affairs'.  The external affairs power supports legislation implementing treaties to which Australia is a party. 

 

Australia has obligations regarding the right to health under Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR).  Article 12(1) of the ICESCR recognises the 'right of everyone to the enjoyment of the highest attainable standard of physical and mental health'.  Pursuant to Article 2(1), Australia relevantly undertakes to 'take steps ... to the maximum of its available resources, with a view to achieving progressively the full realization' of this right by all appropriate means. 

 

In particular, Article 12(2) requires States Parties to take steps 'necessary for: ...

(c)    the prevention, treatment and control of epidemic, endemic, occupational and other diseases;

(d)   the creation of conditions which would assure to all medical service and medical attention in the event of sickness.'

 

Australia also has obligations regarding drug control under the Single Convention on Narcotic Drugs 1961 and the Convention on Psychotropic Substances 1971.  In particular:

*         Article 2(5)(a) of the Single Convention on Narcotic Drugs provides that a Party 'shall adopt any special measures of control which in its opinion are necessary having regard to the particularly dangerous properties' of the drugs listed in Schedule IV of the Convention;

*         Article 4(c) of the Single Convention (read with Articles 2(1) and 2(5)) provides that the Parties 'shall take such legislative and administrative measures as may be necessary ... [s]ubject to the provisions of this Convention, to limit exclusively to medical and scientific purposes the production, manufacture, export, import, distribution of, trade in, use and possession of' the drugs listed in Schedules I and IV of the Convention; and

*         Article 11 of the Convention on Psychotropic Substances imposes obligations in relation to the keeping of records about particular psychotropic substances.

 

The program will provide funding for activities to support the quality use of medicines, including quality prescribing, medicine safety and safety reporting.  The expenditure will also enhance software to improve quality prescribing and enhance the management of the availability of medicines, pharmacovigilance and safety reporting, and the PBS compliance.  Software will also be enhanced to support the safe management and supply of controlled drugs.  These measures work to ensure appropriate treatment is made available and essential drugs are provided safely.  Some of the activities that support the quality use of medicines will prevent, treat and control disease.

 

The program will also provide funding for activities that support the safe management and supply of controlled drugs, and the adequate control of drugs with dangerous properties (including records management).  Some of the activities funded under the program will also support arrangements directed to ensuring that the supply and use of drugs is limited to medical purposes and that drugs are not being misused. 

 

Commonwealth executive power

 

Section 61 of the Constitution supports expenditure on activities relating to the execution and maintenance of the laws of the Commonwealth. 

 

The program will provide funding for measures directed at developing, amending and evaluating policy and regulations under the National Health Act 1953.  It will also provide funding for activities (for example, software development) that support the operation and enhance compliance with the PBS listings under the National Health Act 1953.


Statement of Compatibility with Human Rights

 

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

 

Financial Framework (Supplementary Powers) Amendment (Health Measures No. 2) Regulations 2018

 

These Regulations are 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.

 

Overview of the Legislative Instrument

 

Section 32B of the Financial Framework (Supplementary Powers) Act 1997 (the FF(SP) Act) authorises the Commonwealth to make, vary and administer arrangements and grants specified in the Financial Framework (Supplementary Powers) Regulations 1997 (the FF(SP) Regulations) and to make, vary and administer arrangements and grants for the purposes of programs specified in the Regulations.  Schedule 1AA and Schedule 1AB to the FF(SP) Regulations specify the arrangements, grants and programs.  The FF(SP) Act applies to Ministers and the accountable authorities of non-corporate Commonwealth entities, as defined under section 12 of the Public Governance, Performance and Accountability Act 2013

 

The Regulations amend Schedule 1AB to the FF(SP) Regulations to establish legislative authority for government spending on eight initiatives which will be administered by the Department of Health. 

 

Funding will be provided:

*         to the Royal Flying Doctor Service to deliver dental, mental health and emergency aeromedical services in rural and remote Australia;

*         to the KIDS Foundation for the SeeMore Safety Program to prevent and reduce the effects of childhood injuries, and encourage children to adopt safe practices throughout their lives;

*         to develop resources and training to increase awareness amongst general practitioners and other clinicians of the existence, presenting symptoms of spinal muscular atrophy and referral pathways, including genetic testing for patients at risk;

*         to develop resources to increase awareness amongst general practitioners and other clinicians of the existence, presenting symptoms and possible treatments of endometriosis;

*         to develop educational materials to encourage women with gestational diabetes to undergo testing for future risk of type 2 diabetes;

*         to develop resources and educational materials for pregnant women in relation to managing weight, improving dietary habits and increasing physical activity, and commission research to inform the development of safe pregnancy physical activity guidelines;

*         for health infrastructure projects in regional and remote areas in Australia; and

*         for educational activities to increase the use of biosimilar medicines; the enhancements to software to increase the use of generic and biosimilar medicines and improve electronic prescribing and dispensing arrangements; and software changes to improve the management of controlled drugs.

 

Funding for these initiatives was included in the 2018-19 Budget and the 2017-18 Mid-Year Economic and Fiscal Outlook.

 

The Minister for Health has portfolio responsibility for these matters. 

 

Human rights implications

 

The Regulations do not engage any of the applicable rights or freedoms.

 

Conclusion

 

These Regulations are compatible with human rights as they do not raise any human rights issues.

 

Senator the Hon Mathias Cormann

Minister for Finance

 


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