25 November 2014

Pharmacy location rules – Post–implementation Review – Department of Health

The Department of Health has completed a Post-implementation Review (PIR) on the 2010 decision to renew the pharmacy location rules. These rules prescribe location-based criteria that must be satisfied in order to establish a new pharmacy or relocate an existing pharmacy.

A RIS was required to be prepared for the renewal or retention of pharmacy location rules as these could entail a restriction on competition, and were assessed by the Office of Best Practice Regulation (OBPR) as likely to have a measurable impact on the economy. Because an adequate RIS was not prepared at the decision-making stage, a PIR was required to be prepared within 1-2 years of the implementation of the decision to renew the rules.

The review noted that the costs of extending the location rules include the potential for higher cost of non-subsidised medicines; possibly reduced geographical access to pharmacies in urban areas; and an administrative impost for pharmacists who want to relocate or expand (estimated at $1 million per year). However it found that these costs were outweighed by the benefits of the rules, which maintain a reasonably well-distributed geographical spread of pharmacies in Australia, including (and especially) in rural and remote areas. The review also noted that targeted easing of the rules could provide for greater benefits to the community.

The PIR was completed by the Department of Health in October 2014 and was assessed as adequate by the OBPR.

24 November 2014

Proposed changes to the National Quality Framework for Education and Care Services – COAG Consultation Regulation Impact Statement – Education Council

On 7 November 2014, the Education Council released a Council of Australian Governments (COAG) Consultation Regulation Impact Statement (RIS) containing a number of proposed changes to the Education and Care Services National Law Act 2010, the Education and Care Services National Regulations 2011, and to associated guidance material, all of which are part of the National Quality Framework (NQF).

The Education Council has highlighted potential changes in a number of areas. These include changes to the regulation of Family Day Care services and Outside School Hours Care, as well as the possibility of expanding the scope of services regulated under the NQF.

The COAG RIS for consultation was prepared for the Education Council and has been approved by the Office of Best Practice Regulation. It can be downloaded from the NQF consultation website.

The consultation period closes on 16 January 2015.


13 November 2014

New Standards for Vocational Education and Training (VET) Sector – COAG Decision Regulation Impact Statement – COAG Industry and Skills Council

On 26 September 2014, the COAG Industry and Skills Council endorsed new standards for Registered Training Organisations (RTOs) and VET regulators, and noted that there was a requirement for further development of qualification requirements for teachers delivering the Certificate IV in Training and Assessment. The draft standards were subsequently amended to strengthen requirements for the delivery of this qualification, and the Commonwealth Minister for Industry made the new standards on 20 October 2014 (Standards for Registered Training Organisations 2015 and Standards for VET Regulators 2015). The new standards strengthen requirements for aspects of the delivery of training and assessment, including responsibility for training delivered by a third party, and governance requirements for RTOs; clarify continuing requirements, including requirements for engagement with industry and validation of assessment; and change the Regulator Standards to facilitate a more risk-based approach to regulating RTOs.

In the context of broader national VET reforms, the new standards contribute to addressing employer and other concerns with inconsistency in the relevance and quality of vocational education and training. Specific areas being targeted are the industry-relevance of the development and delivery of training, inadequate skills and knowledge of some VET trainers and assessors, insufficient information for consumers, the complexity of the standards and inadequate enforcement arrangements for poor quality providers. The Regulation Impact Statement (RIS) identified likely transition costs for the sector of $32.6 million, but ongoing savings of around $5 million a year. Benefits for trainees and employers are also anticipated.

The Australian Government Department of Industry’s VET Reform Taskforce prepared a decision‑making RIS that was provided to the COAG Industry and Skills Council to inform the decision. The RIS was assessed as compliant by the Office of Best Practice Regulation.

A consultation RIS was previously prepared by the former Office of the National Skills Standards Council and released for public consultation on 12 March 2013.

13 November 2014

National Livestock Identification System – COAG Decision Regulation Impact Statement – Agriculture Ministers' Forum

On 22 October 2014, the Minister for Agriculture announced that Agriculture Ministers from each State and Territory jurisdiction had agreed to make necessary improvements to the National Livestock Identification Scheme (NLIS) for sheep and goats by building on the systems already in place. The scheme is important for managing biosecurity, food safety, and animal welfare risks. The COAG Decision Regulation Impact Statement (RIS) for improving the NLIS assesses the costs and benefits of three options for improving traceability:

  • Option 1: Enhanced mob-based system— improvements in the verification and enforcement of business rules throughout the supply chain.
  • Option 2: Electronic identification system—the electronic tagging of animals with exemptions for sheep and goats sold directly from their property of birth to abattoirs or export depots.
  • Option 3: Electronic identification system without exemptions.

The RIS identifies Option 1 as the preferred option for implementation and recommends that further work be undertaken at the state level to clarify the appropriate values for initial traceability and implementation costs for all options. The RIS also recommends that the costs and benefits of transitioning from a mob-based system to an electronic identification system be reviewed within five years since the costs of implementing alternative options may change over time with changes in labour and capital costs. The COAG decision RIS was prepared by Australian Bureau of Agricultural and Resource Economics and Sciences for the Agricultural Minister’s Forum, and assessed as adequate by the Office of Best Practice Regulation.

12 November 2014

Australian Transaction Reports and Analysis Centre – Proposed Changes to the Annual Compliance Report – Regulation Impact Statement

On 2 October 2014, the Australian Transaction Reports and Analysis Centre (AUSTRAC) commenced consultation on proposed changes to its annual compliance report.

Certain entities have an obligation to prepare an annual report (the ‘annual compliance report’) relating to their compliance with anti-money laundering and counter terrorism financing rules.

The annual compliance report comprises an online questionnaire with fixed choice responses across 22 key question areas. The report is a component of AUSTRAC’s risk-based approach to supervision of compliance with relevant rules.

The Regulation Impact Statement (RIS) prepared by AUSTRAC for the proposed changes identified three problems with the current arrangements:

  • The current compliance questions are not as relevant as when first developed.
  • The regulatory burden of the current arrangements on certain entities may not be proportionate to their risk of non-compliance.
  • Some stakeholders have indicated that they consider the report to have little or no value to them.

It is proposed to replace the current annual compliance report with an enhanced compliance report and an annual return. The enhanced compliance report is essentially an updated version of the current compliance report while the annual report would require a reporting entity to provide a comprehensive report on its business environment, money laundering and terrorism financing risk and the effectiveness of its anti-money laundering and counter terrorism financing program.

Certain larger business will be required to prepare both reports, while certain smaller and lower risk businesses will only need to prepare the enhanced compliance report.

Overall it is estimated that the proposal will result in a net reduction in the regulatory burden on businesses by $85,200 per year.

The RIS was prepared by AUSTRAC andassessed as consistent with best practice at the early assessment stage by the Office of Best Practice Regulation.



12 November 2014

Pre-market assessment of Australian-manufactured medical devices – Regulation Impact Statement – Department of Health

On 15 October 2014, the Australian Government announced changes to the regulation of therapeutic goods that will allow Australian manufacturers of medical devices to obtain market approval for most of their products using conformity assessment certification from European notified bodies.

Conformity assessment is the examination of evidence and procedures to ensure that both the medical device and the process used to make the device comply with the requirements of the therapeutic goods legislation. Under current arrangements, Australian manufacturers are required to have their products undergo conformity assessment by the Therapeutic Goods Administration (TGA) before their products can be marketed in Australia. If they wish to export their products, Australian manufacturers require an additional assessment by organisations certified by overseas regulators (‘notified bodies’). This is in contrast to overseas manufacturers, who only need to have their products assessed by the overseas notified bodies.

The proposed changes will allow Australian manufacturers to choose to either have conformity assessment conducted by the TGA or an alternative conformity assessment body, such as a European notified body. This will put Australian manufacturers of all but the highest-risk products on an equal footing with those from overseas, avoiding the need for duplicate conformity assessments for those manufacturers wishing to export their products to Europe. In many cases this could allow locally-made medical devices to get to market more quickly. The new rules will not apply to the very highest risk devices, including devices containing medicines or tissues of animal, biological or microbial origin, or Class 4 in vitro diagnostic devices: these devices will still need TGA conformity assessment.

The proposed rule changes have been assessed as likely to have a measurable but contained impact on the economy with minor impacts on competition. On 8 August 2013 a Regulation Impact Statement (RIS) canvassing the proposed changes was prepared by the Department of Health and was published. The RIS was subsequently finalised and certified by the Department consistent with Australian Government best practice regulation requirements, and the OBPR notes that the process followed by the department and the level of analysis contained in the RIS was consistent with best practice.

The RIS estimates the average annual regulatory cost saving at $1.92 million per annum. The OBPR has agreed to the regulatory cost saving.

The RIS can be downloaded from the TGA website.



11 November 2014

Section 457 Visa Reforms – Independent Review – Department of Immigration and Border Protection

On 14 October 2014, the Prime Minister, the Minister for Trade and Investment and the Minister for Immigration and Border Protection announced that the Government will reform the 457 visa programme for skilled migrants.

This follows the Assistant Minister for Immigration and Border Protection announcing an independent review into the integrity of the 457 programme in February 2014.

The 457 programme is a temporary programme aimed at meeting skills shortages. It allows businesses to address labour shortages by sponsoring genuinely skilled overseas workers.

The review was conducted by an independent panel which made several recommendations, which were assessed by the Office of Best Practice Regulation (OBPR) as likely to have a measurable but contained impact on the economy.

The review was certified by the Department of Immigration and Border Protection (the Department) as meeting the requirements of a Regulation Impact Statement for an early assessment. Under the Australian Government Guide to Regulation, the OBPR does not assess independent reviews.

The Department estimates the average annual regulatory savings to be approximately $29.9 million, and this has been agreed by the OBPR for the purpose of consultation.

28 October 2014

Reducing the Regulation of Stock Food and Pet Food – Regulation Impact Statement – Department of Agriculture

On 9 October 2014, the Department of Agriculture released a draft Regulation Impact Statement (RIS) for consultation on Reducing the Regulation of Stock food and Pet food.

The Australian Pesticides and Veterinary Medicines Authority (APVMA) regulate supply aspects of foods for livestock, pets, working animals, show animals and for any product that meets the definition of a Veterinary Chemical Product. The RIS discusses the case for reform to achieve greater alignment of regulatory effort and burden associated with stock foods given the risks posed by these products.

The RIS explores two alternative options for reform:

  • self-determination of Veterinary Chemical Products in which manufacturers would be allowed to self-determine a product’s registration, subject to the product meeting certain requirements relating to claims, labels, manufacture and ingredients; and
  • listing of nutritional/digestive stock food products as chemical products with prescribed criteria similar to the self-determination process but retaining APVMA pre-assessment.

The RIS seeks stakeholder views on the costs and benefits of the options presented. The department is seeking written stakeholder comments on both the RIS and draft regulatory amendments by 7 November 2014.

The proposal has been assessed as likely to have a measurable but contained impact on the economy.

The OBPR has agreed to provisional regulatory cost savings of $7.8 million per annum for the self‑determination option.

28 October 2014

Fire Hose Reels in New Residential Buildings – COAG Decision Regulation Impact Statement – Australian Building Codes Board

In November 2013, the Australian Building Codes Board (ABCB) decided to amend the National Construction Code (NCC) to remove the existing requirement for fire hose reels in new residential buildings, other than houses, and instead require additional fire extinguishers.

Currently fire hose reels are required by the NCC as a first fire attack system provided for use by residents. Although regarded as effective when used correctly, there were concerns that fire hose reels are infrequently, or are inappropriately, used by building occupants when faced by fire. Given they are also expensive to install, the contention was that fire hose reels may not be the most cost‑effective solution.

A Regulation Impact Statement (RIS) compared the cost effectiveness of the status quo against replacing fire hose reels with additional fire extinguishers and found the second option delivered a net benefit of $138 million (in net present value terms) and acceptable fire safety.

The ABCB office prepared a decision RIS that was provided to the Australian Building Codes Board for their decision. The RIS was assessed as compliant by the Office of Best Practice Regulation under the Council of Australian Governments requirements.

The ABCB previously prepared a Consultation RIS on this matter.

27 October 2014

Australian Animal Welfare Standards and Guidelines for Livestock in Saleyards and Depots – COAG Consultation Regulation Impact Statement – Agriculture Ministers’ Forum

On 11 September 2014, the Department of Environment and Primary Industries, Victoria, invited submissions on the proposal to introduce nationally consistent rules for the care and management of livestock during their transition through saleyards and depots in Australia.

Saleyards are places where livestock are bought and sold, usually by auction.  Depots are facilities or yards where livestock may be rested between journeys or holding facilities in a particular region where livestock are delivered from farms for assembly before a journey.

The proposed national standards and guidelines aims to replace the existing Model Code of Practice for the Welfare of Animals at Saleyards and eventually supersede the various state and territory codes of practice.

The RIS suggests that the proposed rules will reduce the risks to the welfare of livestock, and to a lesser extent reduce the uncertainty for the industry and lower the regulatory burden.

The Council of Australian Government (COAG) Consultation Regulation Impact Statement has been prepared by the Victorian Department of Environment and Primary Industries and has been approved by the Office of Best Practice Regulation.

The closing date for submissions is 12 December 2014.