Published impact analyses

Regulation Impact Statement – Therapeutic Goods Administration

On 12 December 2019, the Minister for Health amended the Therapeutic Goods (Medical Devices) Regulations 2002 to incorporate reforms to the Australian medical devices regulatory framework.

The amendments address the rapid emergence of new technologies and rapid uptake of personalised medical devices; the continued need for international alignment; and the lack of suitable alternative mechanisms to manage issues with personalised medical devices.

The amendments:

COAG Consultation Regulation Impact Statement – COAG Transport and Infrastructure Council

On 1 July 2019, the National Transport Commission (NTC) released for public consultation, a Regulation Impact Statement (RIS) examining the safe operation of automated vehicles on Australian roads.

The RIS has been prepared in accordance with Council of Australian Governments (COAG) requirements for the purpose of eliciting information to inform a decision by the COAG Transport and Infrastructure Council on possible national regulatory arrangements for the on-road operation of automated vehicles.

On 17 October 2019, the Government introduced the Anti Money Laundering and Counter Terrorism Financing and Other Legislation Amendment Bill 2019 to Parliament.

The Bill amends the Anti-Money Laundering and Counter‑Terrorism Financing Act 2006 and the Criminal Code 1995, to implement the second phase of reforms in response to the recommendations of the Report on the statutory review of the Anti-Money Laundering and Counter-Terrorism Financing Act 2006 and associated Rules and Regulations.

The Bill contains a range of measures to strengthen Australia’s capabilities to address money laundering and terrorism financing risks, and generate regulatory efficiencies, including amendments to:

On April 7 2014, then Prime Minister Tony Abbot and Prime Minister Shinzo Abe announced the conclusion of negotiations on the Japan-Australia Economic Partnership Agreement (JAEPA).
This agreement was signed on 8 July 2014, and came into force on 15 January 2015.

A Regulation Impact Statement (RIS) was prepared by the Department of Foreign Affairs and Trade to support the decision to endorse the signing of the JAEPA. As this regulatory change was assessed as being highly significant, the Government required a Post-implementation Review (PIR) to be completed within five years of the agreement being implemented.

Independent Review – Australian Prudential Regulation Authority

On 12 December 2019, the Australian Prudential Regulation Authority (APRA) released a new prudential standard for banks and other authorised deposit-taking institutions (ADIs), Prudential Standard APS 220 Credit Risk Management, to replace Prudential Standard APS 220 Credit Quality from January 2021.

The standard places a requirement on ADIs to control credit risk by adopting prudent credit risk management policies and procedures. Credit risk relates to the potential that borrowers will fail to meet their contractual obligations on loans and other credit products.

Non-compliance with COAG’s best practice regulation requirements – Legislative and Governance Forum on Consumer Affairs (CAF)

On 12 December 2019, the Legislative and Governance Forum on Consumer Affairs (CAF) agreed interim and on-going measures to allow complementary medicines which meet certain Australian manufacturing eligibility requirements to make an Australian origin claim, and to have access to the Australian Made, Australian Grown (AMAG) logo. Further details can be found in the announcement.

Regulation Impact Statement – Department of the Treasury

On 5 December 2019, the Treasurer introduced the Treasury Laws Amendment (Research and Development Tax Incentive) Bill 2019, which implements a revised version of the Better targeting the research and development tax incentive measure announced in the 2018-19 Budget and introduced into the previous Parliament in September 2018.

The 2018 Bill was accompanied by a Regulation Impact Statement (RIS) that had been assessed by the Office of Best Practice Regulation (OBPR).

Independent Review – Therapeutic Goods Administration

On 12 December 2019, the Therapeutic Goods Administration introduced changes to the regulatory framework for prescription opioids to address prescription opioid use and misuse in Australia.

Changes will include:

Regulation Impact Statement for consultation – Department of Agriculture

On 20 December 2019, a Regulation Impact Statement on live sheep exports to, or through, the Middle East during the Northern Hemisphere Summer was released for consultation.

The RIS presents three options to manage the risk of heat stress in live sheep exported to, or through, the Middle East during the Northern Hemisphere Summer. The RIS considers the impacts of the status quo; prohibiting live sheep exports from 1 June to 14 September to all ports, with additional prohibited periods for Qatar and Oman; and implementing a revised Heat Stress Risk Assessment (HSRA) model.

More information on the consultation process, including how to make a submission, can be found here.

COAG Consultation Regulation Impact Statement

On 20 December 2019, the Department of Environment and Energy released for public consultation a COAG Consultation Regulation Impact Statement (RIS) on phasing out certain waste exports.

On 9 August 2019 at the meeting of the Council of Australian Governments (COAG), Australia’s First Ministers agreed Australia should establish a timetable to ban the export of waste plastic, paper, glass and tyres, while building Australia’s capacity to generate high value recycled commodities and associated demand.