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National Health Security Amendment Bill 2012
12-02-2013 01:46 PM
House of Reps
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National Health Security Amendment Bill 2012
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(Circulated by authority of the Minister
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THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
NATIONAL HEALTH SECURITY AMENDMENT BILL 2012
(Circulated by authority of the Minister
The Hon Tanya Plibersek MP )
NATIONAL HEALTH SECURITY AMENDMENT BILL 2012
This Bill amends 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).
The NHS Act establishes a scheme for the regulation of SSBAs which:
· enables the Minister for Health to determine the List of Security Sensitive Biological Agents. This list is available on the website of the Department of Health and Ageing at http://www.health.gov.au/ssba#list ;
· sets requirements, in legally enforceable standards, for the secure handling of SSBAs and biological agents suspected of being SSBAs;
· provides for the collection, and recording on a National Register of SSBAs, of information about the nature and location of SSBAs legitimately handled by entities in Australia; and
· includes powers for monitoring compliance with the regulatory scheme through an inspection regime.
The regulatory scheme became operational on 31 January 2009. From feedback from SSBA inspections, the regulated community and other interested stakeholders, amendments have been proposed to enhance the NHS Act to reduce the regulatory burden on an entity that is only required to handle an SSBA for less than seven days (temporary handling) and to provide the Secretary of the Department of Health and Ageing (the Secretary) greater flexibility to better manage the security risks when facilities handling SSBAs are not complying with the SSBA Standards or must undertake emergency maintenance. Other proposed measures relate to providing consistent exemptions for exempt entities handling known or suspected SSBAs, and the reporting of negative confirmatory testing results for suspected SSBAs by registered entities acting as initial testers. Consultations have occurred with targeted stakeholders on the drafting instructions and an exposure draft bill.
To enhance the effectiveness of the SSBA regulatory scheme, the Bill will provide:
- a streamlined reporting regime that will apply to entities that handle SSBAs on a temporary basis to obviate the need for these entities to comply with the full reporting regime applicable to registered entities.
- the Secretary with discretion to accommodate registered facilities undertaking emergency maintenance by removing certain handling requirements or by imposing conditions to maintain security.
- the Secretary with discretion to impose conditions on an entity handling SSBAs during a period of non-compliance with the SSBA Standards, to maintain security of SSBAs.
- Consistent exemptions for exempt entities handling SSBAs or suspected SSBAs.
FINANCIAL IMPACT STATEMENT
The financial impact is nil because these measures enhance an existing regulatory scheme and can be implemented within existing resources.
STATEMENT OF COMPATIBILITY WITH HUMAN RIGHTS
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
This Bill is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011 .
Overview of the Bill
The general purpose of the Bill is to reduce the regulatory burden of certain entities and to provide greater flexibility to enable the Secretary to better manage the security risks when facilities that handle SSBAs are not complying with the SSBA Standards or when emergency maintenance is required. Other proposed measures relate to providing consistent exemptions for exempt entities and the reporting of negative confirmatory testing results for suspected SSBAs by registered entities who are initial testers.
Human rights implications
Certain provisions will require mandatory reporting to the Secretary of the DoHA. This is potentially a limitation on the right to privacy and reputation as this information will include the name and contact information of a person acting as a representative of the entity. This data is required to ensure that the report is made by an authorised representative of the entity and so that contact can be made to verify data. Contact information is held at an appropriate security level for the information obtained.
It is considered these rights can be justifiably limited because of the national security context of handling SSBAs. In addition, the limitations imposed by the Bill are reasonable, necessary and proportionate to the level of risk posed by the type of SSBA.
The Bill is compatible with human rights because to the extent that it may limit human rights, those limitations are reasonable, necessary and proportionate.
The Hon Tanya Plibersek MP, the Minister for Health
NATIONAL HEALTH SECURITY AMENDMENT BILL 2009
NOTES ON CLAUSES
Clause 1 - Short title
This is a formal provision that specifies the short title of the Bill, once enacted, as the National Health Security Amendment Act 2012 .
Clause 2 - Commencement
This clause provides for the commencement of each of the provisions in the Bill. Broadly, the proposed measures in Schedule 1 relating to temporary handlings, emergency maintenance, etc will commence on a day to be fixed by Proclamation.
This will enable related changes to be made to subordinate legislation, such as the National Health Security Regulations 2008 and the Security Sensitive Biological Agent Standards.
However, if any of the provisions do not commence within the period of 6 months after the Bill receives Royal Assent, they commence on the first day after the end of that period.
Clause 3 - Schedule(s)
This clause provides that each Act that is specified in a Schedule to this Bill is amended or repealed as set out by the applicable items in the relevant Schedule, and any other item in a Schedule to this Bill has effect according to its terms. Schedule 1 of the Bill only amends or repeals provisions of the National Health Security Act 2007 (NHS Act).
PART 1 - TEMPORARY HANDLING OF SECURITY SENSITIVE BIOLOGICAL AGENTS
These new arrangements have been designed to reduce the regulatory burden on non-registered facilities that only require up to seven working days in which to complete their handling of an SSBA.
Currently under the NHS Act, a non-registered entity that receives a known SSBA that it knows will only be handled temporarily (for up to seven working days) would be required to fill in an initial registration form. Under this form the entity would not be able to claim compliance with the relevant SSBA Standards and a lengthy administrative procedure would be needed to instruct the entity to dispose of the agent. This procedure would take longer than the projected 7 day or less handing period. In order to reduce this regulatory burden, the amendments under Division 5AA have been proposed.
It should be noted that these arrangement will not apply to suspected SSBAs, which are covered under Division 4A of the NHS Act , as this Division already provides for a streamlined reporting scheme and appropriate Standards .
Items 11 to 14
These items insert definitions for temporary handing disposal report, temporary handling period, temporary handing report and temporary handling Standard .
This item adds a note to subsection 39(1) noting that division 5 will not apply to the handling of security sensitive biological agent by an entity that gives the Secretary a temporary handing report. This means that if a temporary handing report is submitted and all conditions of Division 5AA are met, an entity does not have to apply to register to handle the security sensitive biological agent in this instance.
This item inserts the new Division 5AA.
Division 5AA - Entities that temporarily handle security-sensitive biological agents
Subdivision A - Reporting by entities that temporarily handle security sensitive biological agents.
Under these new arrangements, a facility, such as a hospital diagnostic laboratory, that is temporarily handling a known SSBA would report to the Secretary within two business days that it is handling the SSBA. The facility is permitted seven working days, or a longer period if the Secretary allows, in which to complete the handling of the SSBA before it is required to dispose of the agent through transfer or destruction. Disposal will need to be reported to the Secretary including transfer details or destruction methods. Also under this division, the entity will have requirements to report any lost or stolen samples, unauthorised access to the samples or any other event prescribed by the regulations. These reports may be to DoHA alone, or may also involve reporting to State or Territory Police for lost or stolen SSBAs or unauthorised access.
Under this section, the Secretary will be able to extend the period for disposal where an entity is required to handle an SSBA for a longer period of time, for example, due to other accreditation or legislative requirements such as National Pathology Accreditation Advisory Council or permit applications, or to undertake further diagnostic testing such as antibiotic sensitivity testing.
If such an entity has provided the above reports it will not need to be ‘registered’ on the National Register and it will not be subject to the full reporting and compliance requirements in Division 5, Part 3, that apply to registered entities. If a facility does not choose to submit a temporary handing report, it will then be subject to the requirements of Division 5 and must register to handle.
This division also allow for offence provisions if an entity fails to report handling, disposal or the required events to police.
Subdivision B - Compliance with temporary handling standards
This subdivision allows for the making of standards specifically in regards to temporary handlings. It is expected that these Standards will be similar to those for handling a suspected SSBA and will have requirements in relation to access, storage, transport and disposal of the SSBA and any associated record keeping requirements. As with the other divisions in this Act, non-compliance with the Standards carries offence provisions.
Subdivision C - Conditions in relation to the temporary handling of security sensitive biological agents
Under subdivision C, the Secretary may impose conditions on the temporary handling of a security sensitive biological agent. These conditions must have regard to any security risks posed by the handling of the SSBA and any other matters the Secretary considers relevant, such as any current threat status.
Conditions will relate to the access, storage, transport and disposal of the SSBA, and in circumstances such as when an extension of the handling period is granted. These conditions will allow the Secretary to deal with any additional risks posed by an extension of time for handling, or any specific conditions imposed by specific testing methods.
Failure to comply with the conditions imposed under this subdivision may lead to the Secretary issuing a notice to the entity to dispose of the SSBA and failure to do so is subject to offence provisions.
Items 16A - 16E
This item amends the current headings under Division 5A of Part 3 to include the temporary handling provisions. This change will allow the Minister to suspend Division 5AA to deal with threats involving SSBAs to the health or safety of people, the economy, or the environment.
This item states that the amendments made by the Part apply on or after commencement of the item.
Part 2 - Emergency Maintenance
Items 21A to 22
These items insert definitions for emergency maintenance, emergency maintenance period and emergency maintenance report .
This item inserts sections 55AA to 55 AD dealing with the requirements for emergency maintenance.
Section 55AA - Entity that needs to undertake emergency maintenance may give a report to the Secretary
Section 55AB - Emergency maintenance period
Section 55AC - Secretary may declare an exemption from this Division etc during emergency maintenance period
Section 55AD - Offence - breaching condition of exemption
These sections deal with registered facilities that need to undergo emergency maintenance i.e. unscheduled or unplanned repairs or maintenance to the facility that significantly impacts on the secure handling of the SSBA.
The proposed legislative changes will ensure that entities undertaking emergency maintenance will report the emergency maintenance arrangements, including timeframes and proposed security measures, to DoHA.
As each potential emergency maintenance situation is unique, and as such SSBA Standards cannot be provided to cater to each type of situation, the Secretary will also have capacity to suspend some or all regulatory requirements including application of the relevant areas of the SSBA Standards, if required during the maintenance period. The changes also allow for the Secretary to impose handling conditions to ensure the security of the SSBA during maintenance activities, such as a direction to the entity not to handle the SSBA for any purpose other than to store the SSBA, or impose a condition that if the repairs are not completed within a certain timeframe, the SSBA must be moved to a registered facility. If conditions are applied and these are breached, an offence may apply.
This item states that the amendments under this Part apply on or after commencement of the item.
Part 3 - Compliance with standards relating to security sensitive biological agents
These items add or insert wording to allow the Secretary to impose conditions on entities that are determined to be non-compliant with the SSBA Standards until such time as compliance is achieved.
A failure to comply with the Standards is dealt with in a lengthy administrative process requiring the issue of notices, first to comply and if the entity does not comply within the specified period, then the Secretary may issue a notice for the entity to dispose of the SSBA. These notices define the timeframes within which the non-compliant entity is to achieve compliance by taking corrective action that is indicated by the delegate following an inspection.
It is intended that the Secretary can impose conditions on the entity’s SSBA handlings, so as to reduce the risk posed by the entity’s non-compliance, during the time provided for corrective action to be taken.
It is expected that each entity’s non compliance will be unique so that, similar to the issue of emergency situations above, a general discretion is provided to the Secretary to be able to impose conditions to reduce the security risk posed by a non-compliant entity. Similar to the emergency maintenance situations, these conditions may include a direction to the entity not to handle the SSBA for any purpose other than to store the SSBA. These conditions would be guided by the general principle that when imposing conditions, the entity’s circumstances are considered and the level of security applied is proportionate to the level of risk presented by the handling of an SSBA. The kinds of conditions that will be imposed will relate to the broad security areas included in the SSBA Standards of physical security, including storage, destruction and transport, personnel security and information security.
Part 4 - Confirmatory testing
Items 41 and 42
These items remove the provision for an initial tester which is a registered entity, to not report a negative outcome from in-house confirmatory testing for an SSBA that it is not registered for. Under the NHS Act, other reporting mechanisms require the registered entity to report following a positive result, or to report all results if the confirmatory testing is undertaken by another facility.
However, if a confirmatory test is undertaken in-house by the initial tester and the result is negative, no report will be received. This is a critical gap in the reporting cycle and to ensure comprehensive reporting, it is proposed to require that a registered entity that is an initial tester reports all results of confirmatory testing (whether positive or negative), the same as if the sample was externally tested.
Part 5 - Suspected security sensitive biological agents
This item ensures that an entity listed as an exempt entity is not subject to the reporting and handling requirements for a suspected SSBA. The requirements in the NHS Act at Division 5 apply to entities that handle SSBAs unless they are designated as an ‘exempt entity’ under the Act. It is intended that these exempt entities should also be exempt from the requirements in the Act relating to suspected SSBAs at Division 4A. This is consistent with existing policy but which did not appear to have been included in previous amendments that inserted the suspected SSBA requirements into the NHS Act.
Schedule 2 - Consequential amendments
Items 1 to 6
These items ensure that the new subdivisions and amendments are referred to in the correct places throughout the Act.