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.
Overview
The National Health Security Amendment Act 2009 was enacted by the Parliament of Australia to address gaps and issues identified in the existing regulatory framework for the security of biological agents that could potentially be used as weapons, specifically Security Sensitive Biological Agents (SSBA). The Act was designed to enhance Australia's controls over SSBAs, aligning with international obligations to ensure public health and safety. The Amendment Act received the Royal Assent on 7 October 2009, with certain provisions commencing immediately and others on 31 January 2010 as fixed by a subsequent Proclamation. The policy objective of the Act is to improve the regulatory scheme for SSBAs, ensuring robust controls, immediate response measures for disease outbreaks, and appropriate powers for enforcement and compliance monitoring. The measures introduced include provisions for the Minister to suspend regulatory requirements during an outbreak, new controls for handling suspected SSBAs, enhanced inspector powers, and technical amendments to streamline reporting and registration processes.
Scope and Application
The National Health Security Amendment Act 2009 applies to entities and facilities in Australia that handle security sensitive biological agents (SSBA), which are biological agents that could be used as weapons. The Act amends the National Health Security Act 2007 to enhance Australia’s controls for the security of these agents. It applies to the Minister for Health and Ageing, who is responsible for establishing a list of SSBAs and regulating their handling, as well as to entities and facilities that handle these agents. The Act provides for the collection and recording of information about the nature and location of SSBAs, sets requirements for the secure handling of these agents, and establishes an inspection program to monitor compliance with these requirements. The Act applies nationally across Australia and commenced on 31 January 2010, with certain provisions having commenced earlier on 8 October 2009. The Act does not apply to entities or facilities that do not handle SSBAs. The Act’s application may be extended or restricted through subordinate instruments, such as regulations or determinations made by the Minister.
Key Provisions
The National Health Security Amendment Act 2009 (the Amendment Act) introduces several key provisions to enhance Australia’s controls for the security of biological agents that could be used as weapons, known as security sensitive biological agents (SSBAs). The operative sections of the Amendment Act, particularly Parts 2, 4, 5, and 6, which commence on 31 January 2010, are pivotal in addressing identified issues and improving the regulatory framework for SSBAs. These provisions include new mechanisms to enable the Minister for Health and Ageing to respond swiftly to SSBA-related disease outbreaks, additional controls for the handling of suspected SSBAs, enhanced inspector powers, and minor technical amendments to clarify reporting obligations and the definition of ‘biological agents’.
Under the Amendment Act, the Minister for Health and Ageing is tasked with establishing a list of SSBAs, collecting information about their nature and location, and implementing standards for their secure handling. The Act also mandates the creation of a national register to record relevant details about SSBAs handled by entities and facilities in Australia. Additionally, it outlines the requirements for monitoring compliance with these provisions through an inspection program and sets out the penalties for non-compliance. Entities and facilities handling SSBAs are obligated to adhere to these stringent controls, ensuring that they meet the specified standards for secure handling and reporting. Failure to comply with these requirements can result in significant consequences.
The Amendment Act imposes several obligations on parties and entities governed by it. Firstly, entities handling SSBAs must register with the appropriate authorities and maintain accurate and up-to-date records of their activities. They are required to report any SSBA-related events to the local police forces and comply with the reporting obligations set forth in the Act. Additionally, entities must ensure that their handling of SSBAs adheres to the established standards and regulations. Non-compliance with these obligations can lead to serious repercussions.
There are significant consequences for breaching the provisions of the Amendment Act. The Act provides for both civil and criminal penalties for non-compliance. Specifically, individuals and entities that fail to comply with the requirements for the secure handling and reporting of SSBAs may face fines and imprisonment. The maximum penalties for contravening these provisions are substantial, reflecting the critical nature of maintaining security controls for SSBAs. It is essential for all parties involved to understand and comply with these obligations to avoid facing these severe penalties.