19 August 2016

Clearer labels for medicines

Regulation Impact Statement – Department of Health

On 9 August 2016, the Therapeutic Goods Administration (TGA), part of the Department of Health, announced new requirements for the presentation of information on medicine labels. The new requirements aim to make Australian medicine labels clearer and more consistent and consequently help to avoid medication errors.

The new medicine labelling standards, among other things, require greater prominence and consistent location of information on active ingredients, and specify new allergens to be declared on medicine labels. A four year transition period is provided to allow industry to adopt the label changes with minimal compliance costs.

A Regulation Impact Statement (RIS) was prepared and certified by the TGA under the Australian Government best practice regulation requirements, and has been assessed as compliant and consistent with best practice by the Office of Best Practice Regulation (OBPR).

The RIS estimates the average annual regulatory cost to be $1.1 million a year, and identifies offsets. The OBPR has agreed to the regulatory cost and offset estimates.


4 August 2016

Child and Adult Public Dental Scheme

Regulation Impact Statement – Department of Health

On 5 May 2016 the Government introduced the Dental Benefits Amendment Bill 2016 which proposes changes to create a national Child and Adult Public Dental Scheme. It replaces the means-tested Child Dental Benefits Scheme; a rebate scheme which covers children aged two to 17.

The new scheme will provide financial assistance for dental services to children as well as for adults on concession cards, to be provided through the states and territories.

The Office of Best Practice Regulation (OBPR) assessed the Regulation Impact Statement (RIS) for the proposal prepared by the Department Health as compliant with the Government’s RIS requirements but not best practice. To achieve best practice a considerably higher level of analysis was required to be presented in the RIS.

The RIS estimates the average annual regulatory saving to be $8.9 million per annum, reflecting the reduction in regulatory costs due to the abolition of the Child Dental Benefits Scheme. The OBPR has agreed to the estimates.


25 July 2016

Deregulation of the student visa programme and future directions for streamlined visa processing

Regulation Impact Statement – Department of Immigration and Border Protection

On 16 June 2015, the Australian Government announced the introduction of the Simplified Student Visa Framework (SSVF) to support Australia’s education services sector.

The changes under the SSVF include:

  • a reduction in the number of student visa subclasses from eight to two; and
  • the introduction of a simplified single immigration risk framework for all international students.

The regulation came into effect on 1 July 2016 and the changes are designed to make the student visa framework simpler to navigate, reduce red tape for business, deliver a more targeted approach to immigration integrity and create a level playing field for all education providers.

The Office of Best Practice Regulation (OBPR) assessed the Regulation Impact Statement (RIS) prepared by the Department of Immigration and Border Protection as compliant with the RIS requirements and consistent with best practice.

The Department estimates that the new framework is likely to reduce regulatory costs by $24.1 million per annum compared to previous arrangements. This estimate has been agreed by the OBPR.


25 July 2016

Lupin as a Food Allergen

COAG Consultation Regulation Impact Statement (RIS) – Food Standards Australia New Zealand

On 16 June 2016, Food Standards Australia New Zealand (FSANZ) released a consultation RIS for a proposal to regulate food containing lupin as a food allergen.

Lupin is an emerging food allergen of public health significance in Australia. Lupin belongs to the group of plants known as legumes and therefore contains proteins which are similar to those found in other legumes such as peanut and soy. Like proteins in peanut and soy proteins present in lupin can also be an allergen for some members of the community.

The RIS provides a preliminary examination of the options available for managing potential health and safety outcomes of allergic reactions of lupin in the Australia and New Zealand population.

A Council of Australian Government (COAG) RIS for consultation has been prepared by FSANZ, and assessed as adequate by the Office of Best Practice Regulation.

FSANZ is seeking further information and feedback from industry, consumers and other stakeholders through the call for submissions. Consultations are now open and will close on 28 July 2016.


25 July 2016

Review of the National Safety and Quality Health Service Standards

COAG Consultation Regulation Impact Statement (RIS) – Australian Commission on Safety and Quality in Health Care

On 7 July 2016 the Australian Commission on Safety and Quality in Health Care (the Commission) released a consultation RIS for a review of the National Safety and Quality Health Service (NSQHS) Standards.

The NSQHS Standards were designed to protect the public from harm and to improve the quality of health care for consumers. They are applicable to all health service organisations, and have been used to assess all hospitals and day procedure services since January 2013.

The Commission is undertaking a review of the NSQHS Standards to ensure that they remain current and consistent with best practice.

A Council of Australian Government (COAG) RIS for consultation has been prepared by the Commission, and assessed as adequate by the Office of Best Practice Regulation.

The Commission is seeking further information and feedback from industry, consumers and other stakeholders through consultation. Consultations are now open and will close on 5 August 2016.


22 July 2016

Extractive Industries Transparency Initiative

Regulation Impact Statement – Department of Industry, Innovation and Science

On 6 May 2016, the Government announced that Australia would join the Extractive Industries Transparency Initiative (EITI), an international standard for increased transparency and accountability in the oil, gas and mining sectors.

The EITI provides a global standard for extractive industry companies to publish what they pay to governments, and for governments to disclose what they receive, in the form of taxes, royalties and other statutory payments.

Under the Australian Government’s preferred model for implementing the EITI, large entities will be required to report payments above a pre-determined payment threshold, with industry coverage varying in inverse proportion to the threshold. However, government bodies will report all aggregated payments received. This approach recognises that Australia already has robust reporting mechanisms and compliance arrangements that apply to the extractive industries. As such, it proposes to focus on gaps and localised opportunities for enhanced transparency and effectiveness, rather than examining and reconciling all individual payment data, given Australia’s particular circumstances.

A Regulation Impact Statement (RIS) was prepared by the Department of Industry, Innovation and Science and was assessed as compliant and consistent with best practice by the Office of Best Practice Regulation.

The RIS estimates the proposals will increase regulatory burden by $120,000 per annum. The OBPR agreed to the regulatory costs and offsets.


20 July 2016

Changes to Media Ownership and Control Rules

Regulation Impact Statement – Department of Communications and the Arts

On 2 March 2016 the Minister for Communications introduced the Broadcasting Legislation Amendment (Media Reform) Bill. The bill removes two media ownership and control rules that prevent a person, in their own right or as a director of one or more companies from controlling:

  • more than two of the three regulated media platforms (commercial television, commercial radio and associated newspapers) in any commercial radio licence area (the 2 out of 3 rule); and
  • commercial television licences whose combined licence area populations exceed 75 per cent of the Australian population (the 75 per cent audience reach rule).

It also imposes new local television content requirements on regional commercial television licensees when they become part of a commonly controlled group of licences that collectively reach more than 75 per cent of the Australian population.

The Regulation Impact Statement (RIS) prepared by the Department of Communications and the Arts was assessed as compliant with the Government’s RIS requirements but not consistent with best practice because the level of analysis was not commensurate with the likely impacts on businesses, individuals and competition and the views of stakeholders on the specifics of the preferred options were not clearly identified.

The proposals are expected to increase regulatory burden by $3.51 million on an annualised basis. The regulatory costs were agreed with the OBPR.

As the proposal has been assessed by the OBPR as having a substantial and measureable impact on the media sector and the economy, the Australian Government’s RIS process requires a post‑implementation review to be completed within five years of being implemented.


20 July 2016

Card Payments

Regulation Impact Statement – Reserve Bank of Australia

On 26 May 2016, the Reserve Bank of Australia’s Payments Systems Board announced several changes applying to regulation of debit and credit cards. The changes are intended to strengthen the operation of existing regulations that:

  • limit transactions fees that banks charge each other each time a debit or credit card is used (interchange fees); and
  • prohibit merchants from imposing excessive surcharges on consumers when using a debit or credit card.

The main change the Board made to interchange fees was to introduce caps on any individual interchange fee. No credit card interchange fee will be permitted to exceed 0.80 per cent and no debit card interchange fee will be able to exceed 15 cents if levied as a fixed amount or 0.20 per cent if levied as a percentage amount. Previously, interchange fees were only limited by weighted-average benchmarks.

The weighted-average benchmarks remain the primary element of interchange regulation. The weighted-average benchmark for debit cards will be lowered from 12 cents to 8 cents. The weighted-average benchmark for credit cards remains at 0.50 per cent.

As some of the highest interchange fees are applied to sales by smaller merchants the main beneficiaries of the Board’s changes are likely to be smaller merchants and their customers.

The other key change the Board made was to define permissible surcharges for credit and debit card purchases, which will better enable the Australian Competition and Consumer Commission (ACCC) to enforce rules prohibiting excessive surcharging.

A Regulation Impact Statement (RIS) was prepared and certified by the Reserve Bank of Australia and has been assessed as compliant by the Office of Best Practice Regulation (OBPR). The OBPR has assessed that the process followed by the Reserve Bank of Australia and the level of analysis contained in the RIS was consistent with best practice.

The RIS estimates the average annual regulatory cost at $5.8 million per annum. The OBPR has agreed to the regulatory cost estimates.


17 June 2016

Guidelines for medical practitioners who perform cosmetic medical and surgical procedures

Non-compliance with COAG’s best practice regulation requirements – Medical Board of Australia

On 9 May 2016, the Medical Board of Australia issued mandatory guidelines to apply to all registered medical practitioners who perform cosmetic medical or surgical procedures. The guidelines are given effect under the Health Practitioner Regulation National Law and cover matters such as patient assessment and informed consent, patient management, facilities and advertising practices.

The Council of Australian Governments (COAG) best practice regulation requirements apply to decisions by ministerial councils or national standards-setting bodies where there is a reasonable expectation of widespread compliance. As such, the Office of Best Practice Regulation (OBPR) has assessed that the COAG requirements apply in the case of the decision to issue mandatory guidelines for medical practitioners who perform cosmetic medical or surgical procedures.

Under the COAG requirements a Regulation Impact Statement (RIS) is prepared for the consultation stage, and for the decision stage. A RIS was prepared for consultation by the Australian Health Practitioner Regulation Agency, but a RIS assessed as adequate by the OBPR was not provided for the decision. The OBPR has consequently assessed the proposal as being non-compliant with the COAG best practice regulation requirements at the decision stage.


16 June 2016

Review of the Radiofrequency Spectrum Management Framework

Independent Review – Department of Communications and the Arts

On 25 August 2015, the Government announced its response to the Spectrum Review, agreeing to:

  • replace the current legislative arrangements with new legislation that removes prescriptive process and streamlines licensing, for a simpler and more flexible framework;
  • better integrate the management of public sector and broadcasting spectrum to improve the consistency and integrity of the framework; and
  • review spectrum pricing to ensure consistent and transparent arrangements to support the efficient use of spectrum and secondary markets.

The review was undertaken by the Department of Communications, in conjunction with the Australian Communications and Media Authority, and was certified by the Department as meeting the requirements of a Regulation Impact Statement. Under the Australian Government Guide to Regulation, the Office of Best Practice Regulation (OBPR) does not assess independent reviews.

The Department estimates the average annual regulatory cost savings to be about $450,000, and this has been agreed by the OBPR.