EXPLANATORY STATEMENT
National Health Security Amendment Act 2009
Proclamation
Subsection 2(1) the National Health Security Amendment Act 2009 (the Amendment Act) provides for the commencement of various provisions of the Amendment Act. Items 3, 5, 6, 7 and 8 of the table in subsection 2(1) specify that various Parts of Schedule 1 to the Amendment Act commence on a day to be fixed by Proclamation, but that if any of those provisions have not commenced within six months of the Royal Assent, they will commence on the first day after the end of that period. The Amendment Act received the Royal Assent on 7 October 2009.
The purpose of the Proclamation is to fix 31 January 2010 as the day on which Parts 2, 4, 5 and 6 of the Amendment Act commence. Those provisions amend Part 3 of the National Health Security Act 2007 (the NHS Act) to enhance Australia’s controls for the security of biological agents that could be used as weapons. Such an agent is known as a security sensitive biological agent (SSBA).
Part 3 of the NHS Act gives effect to Australia’s obligations to establish controls for the security of biological agents that could be used as weapons. To achieve this, Part 3 provides for:
- the Minister for Health and Ageing (the Minister) to establish a list of SSBAs;
- the collection, and recording on a national register, information about the nature and location of SSBAs legitimately handled by entities and facilities in Australia;
- requirements to be complied with for the secure handling of SSBAs (including standards);
- monitoring of compliance with reporting and handling requirements through an inspection program;
- inspection powers; and
- penalties for non-compliance.
Since the passage of the NHS Act in September 2007, extensive consultation has been undertaken with stakeholders to develop the administrative and operational detail of the scheme. This included workshops with those entities dealing with SSBA such as research and public health laboratories. As a result of those consultations, areas have been identified where improvements could be made to the legislation.
The Amendment Act addresses the issues identified in those consultations and introduced the following measures:
- new provisions to enable the Minister, following advice from relevant experts, to respond immediately and appropriately to the challenge of safeguarding public health and safety in the event of an SSBA-related disease outbreak. The changes enable the Minister to suspend certain existing regulatory requirements and specify new conditions to ensure that adequate controls are maintained (Part 1);
- new controls relating to the handling of biological agents suspected of being SSBAs which will complement existing provisions relating to controls on known SSBAs
(Part 2);
- additional search and seizure inspector powers to bring the powers in line with those exercised by other regulatory bodies such as the Gene Technology Regulator (Part 3);
- minor and technical amendments to report certain SSBA-related events to local police forces; clarify the reporting obligations of registered entities; enable the Secretary of the Department of Health and Ageing to cancel registration of an entity, on request, where that entity no longer handles SSBAs; and amend the definition of ‘biological agents’ to prevent it being unnecessarily limiting (Parts 4 to 6).
Parts 1 and 3 of the Amendment Act commenced the day after the Act received Royal Assent.
There has been wide dissemination about the commencement of the enhancements to the SSBA Regulatory Scheme. The commencement date has been widely publicised in the SSBA Regulatory Scheme Roadshows that were held in every capital city from July to August 2009. The attendees included representative from laboratories in the areas of animal health, defence, diagnostics, public health and research.
The Department of Health and Ageing will conduct training on compliance requirements for affected stakeholders in November to December 2009.
The Proclamation fixes the day for commencement of Parts 2, 4, 5 and 6 of the Amendment Act as 31 January 2010. That date coincides with the regulation of other agents that are included on the list of SSBAs.
The Proclamation is a legislative instrument for the purposes of the Legislative Instruments Act 2003.