Details of the Financial Framework (Supplementary Powers) Amendment (Health Measures No. 4) Regulations 2018

 

Section 1 - Name

 

This section provides that the title of the Regulations is the Financial Framework (Supplementary Powers) Amendment (Health Measures No. 4) Regulations 2018.

 

Section 2 - Commencement

 

This section provides that the Regulations commence on the day after they are 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 three new table items to Part 4 of Schedule 1AB to establish legislative authority for government spending on activities that will be administered by the Department of Health (the department).

 

New table item 305 establishes legislative authority for government spending on the National Return of Unwanted Medicines Program (the Program).

 

The Program ensures that consumers have free access to collection points to return expired or unwanted medicines by:

*         facilitating the safe and environmentally appropriate collection and disposal of consumers' expired and unwanted prescription, non-prescription and proprietary medicines;

*         consulting with appropriate regulatory and industry bodies, including the Commonwealth Department of the Environment and Energy and relevant state and territory government departments, in developing and agreeing protocols for collection and disposal services; and

*         delivering activities to raise awareness among consumers and health professionals about the availability of the service.

 

 

The purpose of the funding is to contribute to improving the efficient delivery of health services and products that are subsidised or fully funded by the Government.  Storage of expired and unwanted medicines in the home can be harmful, especially to small children and elderly people who may become confused with too many medicines in the home.  Medicines that are disposed of down the household water or sewerage systems, or put in rubbish bins, can also lead to poor environmental consequences.  The main objective of the program is to facilitate a national service, at no cost to the consumer or pharmacy, for the collection and disposal of unwanted or expired medicines by destruction in an environmentally friendly manner.

 

The Government has committed four years of funding for the Program which will facilitate the transportation and incineration of unwanted or expired medicines for approximately 5,500 Australian community pharmacy sites.  The Program is an existing initiative and is demand driven, being dependent on the amount of medicines being returned by consumers.

 

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 page 36.

 

The department will use a targeted, non-competitive grant process to award the grant for the activities in accordance with applicable legislative requirements under the Public Governance, Performance and Accountability Act 2013 and the Commonwealth Grants Rules and Guidelines 2017.  The grant will be administered through the Community Grants Hub.

 

The department will assess a proposal against the eligibility and assessment criteria in the grant guidelines, which will also outline the objectives and outcomes of the government funding and the deliverables.

 

Following assessment of the proposal on its merit, the delegate of the Minister will make the final decision to approve funding.  The Minister's delegate will consider whether the proposal represents an efficient, effective, ethical and economical use of government resources, and whether any specific requirements need to be imposed as a condition of funding.

 

The decision of the Minister's delegate will be 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.

 

The grant guidelines, assessment criteria and information about the grant decision will be available on the GrantConnect website (https://www.grants.gov.au/) and the department's website (www.health.gov.au/internet/main/publishing.nsf/Content/pfps-grantsreporting).

 

The provision of funds to the successful grantee is not considered suitable for independent merits review because the expenditure is a targeted, non-competitive grant where a proposal is received from the existing service provider that has the expertise and resources to deliver these activities, which it has been delivering for 20 years.

 

The current service provider has the appropriate capability, the specific expertise required and established infrastructure, and is considered to be the most appropriate organisation to deliver this program.

 

To reconsider this decision under merits review would substantially delay implementation of the program.

 

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 certain social welfare services and benefits including 'pharmaceutical benefits'.

 

Funding will be provided to a service provider to ensure the proper disposal of medicines supplied by the Commonwealth under the Pharmaceutical Benefits Scheme (PBS), thereby supporting safe and appropriate use of medicines.

 

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 the rights ... by all appropriate means, including particularly by the adoption of legislative measures'.

 

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

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

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

 

Funding for the Program will allow for the collection and disposal of unwanted or expired medicines.  This expenditure will improve the efficiency of health services and products that are subsidised or fully funded by the Australian Government.

 

 

New table item 306 establishes legislative authority for the Government to provide funding to NPS MedicineWise to improve the way health technologies, medicines and medical tests are prescribed and used, thereby supporting the quality use of healthcare services in Australia.

 

Funding will be provided to NPS MedicineWise over four years from 1 July 2018 to deliver the Department of Health's quality use of medicines activities through the Quality use of Diagnostics, Therapeutics and Pathology Program (the Program).

 

Funded activities will target all healthcare professionals (including general practitioners and those in specialist care and through hospitals and pharmacists) and consumers, with the aim of supporting the quality use of healthcare services, including achieving value for money in the Pharmaceutical Benefits Scheme (PBS), and the Medical Benefits Scheme (MBS).  The program objectives and outcomes are to:

*         improve the health of Australians with the quality use of therapeutics by providing independent, evidence-based information and education to health professionals;

*         promote better health outcomes for consumers through education about the quality use of therapeutics;

*         produce savings to the PBS as a result of improved prescribing, dispensing and utilisation of PBS medicines;

*         promote the use of evidence-based requests for diagnostic imaging testing and pathology services through the provision of information and education campaigns for health professionals, leading to savings to the MBS;

*         provide independent, evidence-based information to health professionals and consumers regarding drugs and therapeutics (including new therapeutics) with expert advice and intervention design; and

*         improve prescribing in general practice through the collection and analysis of treatment data.

 

Funding will be directed to NPS MedicineWise, an independent, not-for-profit organisation that provides evidence-based information, support tools and education services to health professionals and consumers to improve the quality use of medicines and diagnostics in Australia.

 

The objective of the expenditure is to improve the efficiency of health services and products that are subsidised or fully funded by the Australian Government.

 

NPS MedicineWise conducts a range of activities for prescribers, pharmacists and consumers, including practice visits, online education modules, providing consumer resources and publications, and conducting campaigns, with an aim to bring awareness and evidence-based education to improve the responsible management and treatment of health conditions.

 

NPS MedicineWise also collects primary care data extracted from the clinical software of a nationally representative sample of general practices, providing longitudinal patient information.  The data can be used to identify how medicines are used and areas for improved prescribing and use of diagnostics, and related policy.

 

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 page 36.

 

The Department will seek the Minister's authority to commit funds for the grant opportunity to implement the Program. 

 

The department will use a targeted, non-competitive grant process to award the grant in accordance with applicable legislative requirements under the Public Governance, Performance and Accountability Act 2013 and the Commonwealth Grants Rules and Guidelines 2017.  The grant will be managed through the Community Grants Hub.

 

The department will assess the application from NPS MedicineWise against the eligibility and assessment criteria in the grant guidelines, which will also outline the objectives and outcomes of the government funding and the deliverables. 

 

Following assessment of the proposal on its merit, the delegate of the Minister will make the final decision to approve the funding.  The Minister's delegate will consider whether the proposal represents an efficient, effective, ethical and economical use of government resources, and whether any specific requirements need to be imposed as a condition of funding.

 

The decision of the Minister's delegate will be 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.

 

The grant guidelines, assessment criteria and information about the grant decision will be available at the GrantConnect website (www.grants.gov.au) and the department's website (www.health.gov.au/internet/main/publishing.nsf/Content/pfps-grantsreporting).

 

The provision of funds to the successful grantee is not considered suitable for independent merits review because the expenditure is a targeted, non-competitive grant where the NPS MedicineWise has the expertise and resources to deliver these activities which it has been delivering for 20 years.

 

As NPS MedicineWise has the appropriate capability, the specific expertise required and established infrastructure, it is considered to be the most appropriate organisation to deliver this program.

 

To reconsider this decision under merits review would substantially delay implementation of the program.

 

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 certain social welfare services including 'medical and dental services'.

 

Funding will be provided to NPS to improve the way health technologies, medicines and medical tests are prescribed and used, thereby supporting the quality use of healthcare services in Australia.

 

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 the rights ... by all appropriate means, including particularly by 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:

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

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

 

Funding to NPS will provide evidence-based information, support tools and education services to health professionals and consumers to improve the quality use of medicines and diagnostics in Australia.

 

New table item 307 establishes legislative authority for government spending on the Value in Prescribing Program (the Program).

 

Under the Program, grant funding will be provided for the delivery of educational information and resources to promote the appropriate and efficient usage of medicines and immunoglobulin (Ig) blood products.  The aim of the Program is to support the quality use of healthcare services, including achieving value for money in the Pharmaceutical Benefits Scheme (PBS) and under the National Blood Agreement.

 

 

The program objectives and outcomes are to:

*         improve and support best practice decision-making in prescribing medicines and blood products;

*         promote the use of effective alternatives where clinically supported for particular conditions to ensure appropriate usage of medicines and immunoglobulin (Ig) blood products;

*         promote the use of more cost effective medicines, where cheaper generic or biosimilar medicines are available under the Pharmaceutical Benefits Scheme (PBS); and

*         reduce unnecessary prescribing of PBS medicines and Ig blood products.

 

The grant will fund activities to provide targeted intervention such as educational visits to specialists to provide information about evidence-based best practice to help influence prescribing habits to effect an improvement; and education and awareness activities for appropriate and cost-effective prescribing of medicines and blood products, specifically biological disease-modifying anti-rheumatic drugs (bDMARDS) and Ig.  The program is aimed at specialist prescribers, healthcare professionals and consumers and is intended to deliver improvements in prescribing of these expensive products by specialists, including reducing the potential for wastage.

 

The purpose of the funding is to improve the efficiency of specialist health professionals in prescribing products that are partially or fully funded by the Government.

 

The program will be delivered nationally, through a grant program, over four financial years, commencing in 2018-19.

 

One open competitive approach to market will be undertaken (expected in October 2018), with two funding streams:

1.      the bDMARDS funding stream; and

2.      the Ig blood products funding stream.

 

Pending the outcome of this process, there may be one or two grant agreements with the successful applicants.

 

Funding was included in the 2018-19 Budget under the measure 'Improving Access to Medicines - Strengthening the Quality Use of Healthcare Services' 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 114.

 

Funding for this item will come from Program 4.3: Pharmaceutical Benefits, which is part of Outcome 4 and Program 1.1: Health Policy Research and Analysis, 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 pages 30 and 36.

 

The Department will seek ministerial authority to commit funds for the grant opportunity to implement the Program.  

 

The department will use an open and competitive process to award grants in accordance with applicable legislative requirements under the Public Governance, Performance and Accountability Act 2013 and the Commonwealth Grants Rules and Guidelines 2017.  The grants will be managed through the Community Grants Hub.

 

The department will assess applications received 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 Minister will make the final decision to approve funding.  The delegate will consider whether the proposal represents an efficient, effective, ethical and economical use of government resources, and whether any specific requirements need to be imposed as a condition of funding.

 

The decision of the Ministers' delegate will be 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.

 

The grant guidelines, assessment criteria and information about the grant decision will be available at the GrantConnect website (www.grants.gov.au).

 

The provision of funds to the successful grantee(s) is not considered suitable for independent merits review because the expenditure is one-off, time-limited and will only have a maximum of two grants available, one grant for the bDMARDS stream and one for the Ig stream.  If one grantee is successful for both grants these may be combined into one grant.

 

The open competitive approach to market is to test who is interested in delivering the grant activities.  It is expected that it may have a single, or at most two, grant recipients.  It is expected that few organisations will have the capability and necessary expertise available to deliver the requirements.

 

To reconsider this decision under merits review would substantially delay commencement and implementation of the program.

 

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 certain social welfare services and benefits including pharmaceutical, sickness and hospital benefits and medical and dental services. 

 

Funding will be provided to deliver educational activities on the appropriate use of the PBS and blood products subsidised under national blood arrangements, thereby supporting safe and appropriate use of Commonwealth-funded medical services and pharmaceuticals in Australia.

 

 

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 international obligations under 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 realisation' of the rights ... 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) to include:

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

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

 

Funding will be provided to develop tools and educational materials to promote the safe and appropriate use of PBS medicines and Immunoglobulin products.  Funding will also be provided to provide tools and resources to support the clinically appropriate use of cheaper alternatives within classes of PBS-subsidised medicines.

 

 

 

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. 4) 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 PGPA Act. 

 

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

 

Funding will be provided for:

*         the National Return of Unwanted Medicines Program to provide consumers with free access to collection points for the return and disposal of expired or unwanted medicines;

*         NPS MedicineWise to deliver evidence-based information support tools and education to health professionals and consumers to improve the way health technologies, medicines and medical tests are prescribed and used; and

*         Value in Prescribing Program for the delivery of educational information and resources to promote the appropriate and efficient use of medicines and immunoglobulin blood products, with the aim of reducing the unnecessary prescribing of medicines and blood products.

 

Funding for these initiatives was included in the 2018-19 Budget.

 

The Minister for Senior Australians and Aged Care 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 and the Public Service