Published Impact Analyses

On 30 May 2013, the Minister for Climate Change, Industry and Innovation Greg Combet introduced the Intellectual Property Laws Amendment Bill 2013, which includes amendments to the Crown Use provisions. Crown use provisions allow governments to access patented inventions under specific circumstances. A recent Productivity Commission Inquiry into Compulsory Licensing of Patents found that there was significant uncertainty around the use of Crown use provisions. It was found that the scope of the types of entities that can actually make use of the Crown use provisions is unclear, particularly in the healthcare field, and there is a lack of transparency and accountability associated with the Crown use provisions. The proposed amendments:

On 28 May 2013, the Attorney‑General announced that organisations will be required to notify individuals of a data breach where they face a real risk of serious harm. Currently organisations are encouraged to disclose data breaches voluntarily. Data breaches can result in financial loss and impose psychological damage on individuals. There is also general evidence that data breaches internationally are increasing. Depending on the current level of under reporting of data breaches, mandatory disclosure may help more individuals take steps to mitigate against the possibility of financial loss from identity theft. It is also intended that mandatory disclosure of data breaches will promote better behaviour in relation to security of personal information and compliance with other privacy obligations.

In February 2008, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) Director published a notice in the Chemical Gazette proposing variations to the Australian Inventory of Chemical Substances (AICS) for 15 lead compounds to restrict their use in industrial surface coatings and inks. The changes were introduced in a phased manner from 1 April 2008 with a complete phase out from industrial surface coatings from 1 January 2009. A Regulation Impact Statement was required for the decision to introduce restrictions on the use of lead compounds in industrial surface coatings and inks, but was not prepared. As a result, a Post-implementation Review (PIR) was required to be undertaken in line with the Government’s best practice regulation process.

In the 2013-14 Budget, released on 14 May 2013, the Australian Government announced its decision to establish a national patient contact register for implantable devices, and two clinical quality registers for breast implants and cardiac devices. The Government had previously prepared a Regulation Impact Statement (RIS) to support an in-principle decision to develop clinical registers for high risk implantable medical devices, and committed to examine options to track the use and performance of such devices and funding models. The purpose of this implementation RIS was to assist the Australian Government in deciding how to best implement the decision to support the registers.

On 14 May 2013, as part of revenue measures announced in the Australian Government’s 2012-13 Budget, the Government announced new levies for the olive industry. The levies commenced on 1 May 2013. The olives industry’s perception is that greater expenditure on research and development (R&D) is required in order to:

On 21 May 2013, the Department of Health and Ageing issued a revised Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy (HCT) products. The proposed update seeks to improve the safety and quality of HCT products supplied in Australia. The update intends to align manufacturing requirements with industry practice and international regulation. The update will also remove technical requirements from the Code which will be transferred to a new Therapeutic Goods Order: Standards for minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products.

On 28 March 2013 the Council of Australian Governments’ (COAG) Select Council on Housing and Homelessness announced that a phased introduction of the National Regulatory System (NRS) for Community Housing would commence on 1 July 2013. There will be a six month trial implementation involving a small number of community housing providers (approximately 25), with registration for providers in general to commence from 1 January 2014 in those jurisdictions which have passed legislation that mirrors the Community Housing Providers National Law. Community housing is housing assistance delivered by community organisations to people on low to moderate incomes with a housing need.

On 29 April 2010, the then Prime Minister announced a one-off increase of 25 per cent to the excise and excise‑equivalent customs duty applying to tobacco products. The increase was intended to progress recommendations of the National Preventative Health Strategy Report and the Australia’s Future Tax System Review in reducing the affordability of tobacco products. A Regulation Impact Statement was not prepared by the Department of the Treasury for the joint proposal. Consequently, a Post-implementation Review (PIR) was required to be undertaken in line with the Government’s best practice regulation process. The PIR found that the one off increase in tobacco excise and excise equivalent customs duty met three of four identified policy objectives. In particular, the increase in excise:

On 13 May 2013, the Australian Communications and Media Authority (ACMA) announced that it was seeking public comment on proposed regulatory changes to establish a more efficient and effective set of identity verification requirements for prepaid mobile carriage services. This initiative follows a review by an industry and government working group led by the Department of Broadband, Communications and the Digital Economy (DBCDE) and a request from the Minister for Broadband, Communications and the Digital Economy to the ACMA to introduce the necessary regulatory changes. The review and Minister’s request were supported by a Regulation Impact Statement (RIS) prepared by DBCDE on Changes to Identity Verification Requirements for Prepaid Mobile Services. Prepaid mobile services are viewed as a popular option for users with low usage requirements and basic or inexpensive handsets.

On 3 May 2013, the Standing Council on Primary Industries (SCOPI) announced a decision on reforms to the single national regulatory framework for agricultural and veterinary chemicals (AgVet chemicals). These reforms seek to harmonise the assessment, registration and the control-of-use elements. (Control-of-use refers to the regulation of AgVet chemical use after the point of retail sale that is regulated at the jurisdictional level.) The national scheme addresses the issues that have arisen from the highly fragmented control-of-use systems of the states and territories. These include the uncoordinated risk management of AgVet chemicals, inconsistent regulation of user access to chemicals and unnecessary regulatory burden as a result of duplication.