Regulation Impact Statements

Page last updated: 16 February 2016

Government policy makers are required to assess the benefit of their proposed decisions against the effects they may have on business, community organisations and individuals. A key focus of the regulatory reform agenda is the identification of the regulatory impact of major decisions. The tool used to document the assessment of viable policy options, including the option of regulating, is a Regulation Impact Statement (RIS). In most cases, a RIS will be a public document, addressing:

  • What the problem is that needs to be solved?
  • Why government action is needed?
  • What policy options are being considered?
  • What is the likely net benefit of each option?
  • Who needs to be consulted about the options and how will this be achieved?
  • What is the best option from those that have been considered?
  • How will the chosen option be implemented and evaluated?

The Office of Best Practice Regulation (OBPR) administers the government’s regulatory impact analysis requirements. The OBPR is a branch within the Department of the Prime Minister and Cabinet's (PM&C) Regulatory Reform Division.

To encourage policy makers to think about regulatory impacts early in the policy process, PM&C has produced a handbook to guide regulation, The Australian Government Guide to Regulation

Health Portfolio Regulation Impact Statements


Proposed Changes to the Personally Controlled Electronic Health Record System Regulation Impact Statement - 21 July 2015
Industrial Chemicals Assessment Reforms – Regulation Impact Statement - 5 June 2015
Amendments to the New Regulatory Framework for In-vitro Diagnostic Medical Devices – Regulation Impact Statement - 16 April 2015
Pre-market Assessment of Australian-manufactured Medical Devices – Regulation Impact Statement - 12 November 2014
Changes to Required Advisory Statements for Medicine Labels – Regulation Impact Statement - 4 July 2014
Protection of Images and Indicia for Major Sporting Events – Final Regulation Impact Statement - 3 April 2014