REVIEW OF PRE-2008 COMMONWEALTH SUBORDINATE LEGISLATION AND OTHER REGULATION
Review Summary for the Health and Ageing Portfolio
Overview
In February 2009, the Government announced in the Updated Economic and Fiscal Outlook that it would undertake a review of pre-2008 Commonwealth subordinate legislation and other regulation (the Review) in order to document those regulations which impose net costs on business and identify scope to improve regulatory efficiency. The Department of Finance and Deregulation (Finance) has been tasked to
co-ordinate the review on the Government’s behalf. This report focuses on the review of subordinate legislation and other regulations administered within the Health and Ageing portfolio (the portfolio).
The portfolio develops policy advice and administers programs to improve health and ageing outcomes for all Australians. The majority of the portfolio’s activities have a direct regulatory impact on a wide variety of businesses operating in the health and ageing sector including hospitals, health insurers, health technology manufacturers and medical professionals.
Health policy
A major focus of the portfolio is the provision of subsidised health services to Australian citizens, through the Medicare Benefits Program (MBP) and Pharmaceutical Benefits Program (PBP). In this report the operation of the MBP is covered by the Medicare Regulations, the Pathology Regulations and the Diagnostic Imaging Services Regulations clusters. The operations of the PBP are covered by the Pharmaceuticals Regulations cluster. In addition to detailing the fee schedules of services, drugs and devices which receive subsidies, these regulations outline administrative requirements that service providers must meet in order to have access to public funding.
This report highlights a number of legislative and review processes that are currently taking place in relation to the MBP and the PBP. No further review activity is recommended in this area.
Other important functions undertaken by the portfolio include regulating the access of health technologies to the Australian market (Therapeutic Goods Regulations) and regulating the activities of private health insurers (Private Health Insurance Regulations). Aspects of the regulatory frameworks for both therapeutic goods and private health insurance were examined as part of the Health Technology Assessment Review (2009) which was conducted as a Better Regulation Ministerial Partnership.
In addition, the report notes that: the regulatory framework for therapeutics goods has been and continues to be extensively reviewed from a regulatory perspective; and the framework surrounding private health insurance has been and continues to be the subject of close policy scrutiny.
The report highlights two health related areas that would benefit from review: radiation protection and nuclear safety; and the vocational registration of general practitioners. It is also recommended that the portfolio, in considering its response to a Senate Committee Report on Hearing Health, reviews the regulatory framework surrounding hearing services to determine the ongoing efficiency and effectiveness.
Ageing Policy
The portfolio’s activities in this area are centred on the Aged Care Act 1997 and its subordinate legislation. The Productivity Commission’s Annual Review of Regulatory Review Burdens on Business: Social and Economic Infrastructure Services (2009) focussed on a number of industries, including the aged care industry. The review recommended a number of reforms to aged care, including the removal of duplicate or inconsistent accreditation regulations and the streamlining of building certification standards compliance. On that basis this report makes no further comment on aged care legislation.
A number of instruments relating to nursing homes and enabled by the National Health Act 1953 remain within the scope of this review. The report notes that the majority of these instruments appear to be redundant and recommends action is taken to determine their status and to remove instruments where appropriate.
Other Recommendations
Only two instruments in two clusters were found to be redundant. Notwithstanding this, the report notes that reviews of both the national health regulations and the pharmaceutical regulations would be likely to identify a significant number of redundant instruments.
Further, the review has identified five clusters which contain a large number of amending instruments. It is recommended that action be taken to update the Federal Register of Legislative Instruments to indicate where amending instruments have ceased.
The Health and Ageing Portfolio
The portfolio comprises the Department of Health and Ageing (DHA) and 22 statutory agencies. The roles and responsibilities of these agencies are outlined at Attachment A.
Data provided by the Office of Legislative Drafting and Publishing identified
1385 instruments on the Federal Register of Legislative Instruments (FRLI) administered within the portfolio. Following consultation between Finance and DHA,
1092 instruments (at Attachment B) were grouped into 29 broad policy clusters. These clusters were agreed between Finance and DHA as falling within the scope of the Review.
The remaining 294 instruments, grouped into 6 policy clusters (at Attachment C) were excluded on the basis of current or recent reviews into the area. Details are at
Attachment D.
The legislative instruments have been grouped into clusters to focus analysis at the policy level, rather than on individual instruments. The portfolio provided additional information against each ‘in-scope’ cluster, including: the policy objective of the regulation; its ongoing relevance and impact; review history; and how it operates.
The following provides detail on each of the 29 ‘in-scope’ policy clusters, including background information, relevant review history and Finance’s recommendations.
1. Australian Institute of Health and Welfare Regulations
Total number of instruments within cluster: 3
Number of amending or machinery instruments: 1
The Australian Institute of Health and Welfare (AIHW) collects health and welfare related data, to facilitate research and the development of public policy.
The Australian Institute of Health and Welfare Regulations 2006 increase the value of a contract that the AIHW can enter into without Ministerial approval from $200,000 to $1,500,000.
The Australian Institute of Health and Welfare Ethics Committee Regulations 1989 outline the operation and functions of the AIHW Ethics Committee. The Committee’s role is to assess the ethical and privacy implications of research proposals that seek to use identifiable data from the AIHW. The Committee is then able to approve, deny or impose conditions on a researcher’s use of the information. The AIHW has a complaints process in place which allows for independent review of an application and have not received any complaints to date.
Recommendation
Finance recommends that no action be taken with respect to these machinery instruments.
2. Australian Radiation Protection and Nuclear Safety Regulations
Total number of instruments within cluster: 12
Number of amending or machinery instruments: 10
The instruments in this cluster: prescribe limits to radiation activity levels for various facilities; list exemptions to these limits; and set out the internal governance procedures for the Radiation Health and Safety Advisory Council.
Of principal interest from a regulatory perspective, the regulations also set out requirements for the handling and management of controlled facilities and controlled apparatus in both medical and industrial situations. A controlled facility is a nuclear installation or a prescribed radiation facility. A controlled apparatus is an apparatus that produces harmful non-iodizing radiation when energised.
These regulations impose significant regulatory costs on business and hospitals, particularly in relation to obtaining and maintaining a licence. For example, there are five codes of practices that a user must abide by as a condition of holding a licence.
The portfolio has advised that the regulations have not been reviewed since their introduction in 1998 and that a review of these instruments and their enabling Act is appropriate, as they have now been in operation for more than ten years.
Recommendation
Finance recommends that a review of the radiation protection and nuclear safety regulatory framework be undertaken to ensure that the regulatory framework remains effective and efficient and that the regulatory cost imposed on business is proportionate to risk.
3. Australian Sports Anti-Doping Authority (ASADA) Regulations
Total number of instruments within cluster: 6
Number of amending or machinery instruments: 5
The Australian Sports Drug Agency Regulations outline the National Anti-Doping (NAD) Scheme as required by the UNESCO International Convention Against Doping in Sport. The NAD Scheme requires athletes to be tested for prohibited substances and potential violations to be investigated. The scheme also requires sporting bodies to provide and administer anti-doping schemes in co-operation with the ASADA and to act on any request from ASADA in relation to the provision of drug education programs. In addition, the regulations outline the internal governance procedures for ASADA.
The portfolio has advised that the NAD Scheme was reviewed and amended in 2008 to ensure that the scheme remained compliant with the World Anti-Doping Code and the UNESCO International Convention Against Doping in Sport.
Recommendation
Finance recommends that no action be taken with respect to this cluster.
4. Commonwealth Serum Laboratories (Conversion into Public Company) Regulation
Total number of instruments within cluster: 1
Number of amending or machinery instruments: 1
The Commonwealth Serum Laboratories (CSL) Regulations outlined the procedures for converting the CSL into a public company in compliance with the Companies Act 1981.
CSL was established in 1916 to conduct research into and develop new vaccines, thereby creating a domestic source of vaccine technology and limiting Australia’s dependence on international supply.
In 1990, the CSL was converted into a publicly listed company. In 1994, the Commonwealth Serum Laboratories Regulations and four amending instruments were repealed. The Commonwealth Serum Laboratories (Conversion into Public Companies) Regulations have not yet been repealed and have no ongoing relevance.
Recommendation
Finance recommends that the Department of Health and Ageing take action to repeal this redundant instrument.
5. Diagnostic Imaging Services Regulations
Total number of instruments within cluster: 21
Number of amending or machinery instruments: 20
Under the Health Insurance Act 1973, rural and remote GPs must participate in approved continuing medical education and quality assurance programs. The ‘Health Insurance (Diagnostic Imaging - Continuing Medical Education and Quality Assurance Programs) Approval 2000’ Regulations specify programs which are considered as approved.
The remainder of instruments in this cluster relate to the routine updating of the Diagnostic Imaging Services Table which is part of the Medicare Benefit Schedule. The regulations specify details regarding the Medicare benefits available for diagnostic imaging services, including the eligibility requirements for specific services. All of these instruments are amending instruments and a number of these appear to have no ongoing effect.
The most recent Diagnostic Imaging Services Table is contained in the Health Insurance (Diagnostic Imaging Services Table) Regulations 2010, registered in January 2010. As this instrument was made after 2008, it was not included in the dataset upon which the pre-2008 review of subordinate legislation and other regulations was conducted.
More broadly, Finance notes that the Department of Health and Ageing is conducting a detailed review of funding for diagnostic imaging services that is due to report in mid 2010. The outcome of this review may entail significant regulatory change for the diagnostic imaging services industry. It is expected that the Government’s decisions in response to the review will be reflected in the 2011-12 budget.
Recommendation
Finance recommends that action is taken to update the Federal Register of Legislative Instruments to indicate where amending instruments have ceased.
6. Epidemiological Studies (Confidentiality) Regulations
Total number of instruments within cluster: 7
Number of amending or machinery instruments: 6
The Epidemiological Studies (Confidentiality) Act 1981 outlines the rules and procedures for medical studies involving sensitive information about individuals. Any party conducting such a medical study is required to follow strict protocols when collecting and communicating information about an individual. A number of these protocols remain in effect even after conclusion of the study.
The Epidemiological Studies Regulations specify the particular studies which are subject to these protocols.
Recommendation
Finance recommends that no action be taken with respect to this cluster.
7. Food Standards Australia and New Zealand Regulations (formerly the National Food Authority Regulations)
Total number of instruments within cluster: 4
Number of amending or machinery instruments: 2
The Food Standards Code sets out a number of requirements related to the production and sale of food substances including safety, handling and labelling aspects. Individuals and groups can apply to FSANZ for new standards to be added to the Code or for a variation to be made to an existing standard.
FSANZ assesses the information submitted against the application guidelines, as set out in the ‘Food Standards Australia New Zealand Act 1991 – Application Handbook’, to determine whether the application should be added to their forward work plan. The portfolio has advised that the Application Handbook was last reviewed in August 2009, including significant stakeholder consultation.
The ‘National Food Authority Regulations’ 1994 outline a number of processes which facilitate the operations of FSANZ in assessing applications, including ways in which the process can be fast tracked in appropriate circumstances.
In 2004, the National Food Authority Act 1991 was renamed the Australia New Zealand Food Authority Act 1991 and the National Food Authority Regulations was renamed the Food Standards Australia New Zealand Regulations. The portfolio has advised that, as a result, the transitional ‘Food Standards Amendment Act 2007 Proclamation’ is no longer required and can be repealed.
While businesses incur costs as a result of the application process, it is the inconsistent application and enforcement of Food Standards Codes, particularly across different state and territory jurisdictions that imposes a more significant cost on business.
Food regulation reform is part of the National Partnership Agreement to Deliver a Seamless National Economy, oversighted by the Business Regulation and Competition Working Group (BRCWG). In December 2009, COAG agreed to the Commonwealth Parliamentary Secretary for Health, in consultation with the Australia New Zealand Food Regulation Ministerial Council (ANZFRMC) drafting an Intergovernmental Agreement (IGA), for COAG’s consideration by mid-2010. The IGA:
· amends the voting arrangements of the ANZFRMC so that, except in relation to the review of food standards, decisions of the ANZFRMC are unable to be made by consensus and require a two-thirds majority; and
· proposes reforms to enable, by 1 July 2011, centralised interpretive advice to be provided in relation to food standards on a primarily cost-recovery basis, which would be adopted and applied by all State and Territory food regulatory agencies in the course of their monitoring and enforcement activities relating to food standards