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2010-2011-2012
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
NATIONAL HEALTH SECURITY AMENDMENT BILL 2012
EXPLANATORY MEMORANDUM
(Circulated by authority of the Minister for Health,
The Hon Tanya Plibersek MP)
NATIONAL HEALTH SECURITY AMENDMENT BILL 2012
OUTLINE
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.
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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.
Conclusion
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
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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).
SCHEDULE 1 - AMENDMENTS
PART 1 - TEMPORARY HANDLING OF SECURITY SENSITIVE BIOLOGICAL
AGENTS
Outline
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.
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Item 15
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.
Item 16
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.
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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.
Item 19C
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.
Item 23
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.
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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.
Item 24
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
Items 31-37
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.
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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
Item 51
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.
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