Bills Digest no. 15 2009–10
National Health Security Amendment Bill
2009
WARNING:
This Digest was prepared for debate. It reflects the legislation as
introduced and does not canvass subsequent amendments. This Digest
does not have any official legal status. Other sources should be
consulted to determine the subsequent official status of the
Bill.
CONTENTS
Passage history
Purpose
Background
Financial implications
Main provisions
Concluding comments
Contact officer & copyright details
Passage history
Date
introduced: 24 June
2009
House: House of Representatives
Portfolio: Health and Ageing
Commencement: Sections
1-3: on Royal Assent
Parts
1 and 3: the day after Royal Assent
Parts
2, 4, 5 and 6: the earlier of a date fixed by proclamation or 6
months after Royal Assent
The
relevant links to the Bill, Explanatory Memorandum and second
reading speech can be accessed via BillsNet, which is at http://www.aph.gov.au/bills/.
When Bills have been passed they can be found at ComLaw, which is
at http://www.comlaw.gov.au/.
The National Health Security Amendment Bill 2009 (the Bill)
amends the National Health Security Act 2007 (the Act) to
make arrangements for the safe handling of security sensitive
biological agents (SSBAs) that could be used as weapons.
The National Health Security Regulations 2008 (the NHS
Regulations) were made on 12 December 2008. The NHS Regulations
support the operation of the Act and provide detail about the
operation of the SSBA Regulatory Scheme outlined in the Act.
Implementation of Part 3 of the Act in 2008
identified how the SSBA Regulatory Scheme might be enhanced. The
Bill gives effect to those recommendations.
Under Part 3 of the Act, the Minister must
establish a list of biological agents that are considered to be a
security concern to Australia. There are two tiers of SSBAs: tier 1
(those considered to be of greatest risk to Australia) and tier 2
(considered less likely to be a threat to Australia). Regulation of
tier 1 SSBAs commenced on 31 January 2009. Tier 1 SSBAs are as
follows:
Abrin (5mg)
Bacillus anthracis (anthrax-virulent
strains)
Botulin toxin (0.5mg)
Ebolavirus
Foot-and-mouth diseases virus
Highly pathogenic influenza virus, infecting
humans
Marbugvirus
Ricin (5mg)
Rinderpest virus
SARS coronavirus
Variola virus (smallpox)
Yersina pestis (plague).[1]
Tier 2 SSBAs will be regulated from January 2010 and published
on the Department of Health and Ageing s (DoHA) website in late
2009. To date, the following SSBAs have been indentified as Tier
2:
African swine fever virus
Capripoxvirus (sheep pox virus and goat pox
virus)
Classical swine fever virus
Clostriduim botulinum (botulism; toxin
producing strains)
Francisella tularensis (Tularaemia)
Lumpy skin virus
Peste-des-petits-ruminants virus
Salmonella Typi (Typhoid)
Vibro cholerae (cholera) (serotypes O1 and
O139)
Yellow fever virus.[2]
The National Health Security (SSBA Standards) Amendment
Determination 2009 (No 1) (the Determination), lodged on the
Federal Register of Legislative Instruments (FRLI) on 30 June 2009,
removed the requirement for background checking of authorised
persons and persons recruited to handle Tier 1 SSBAs or sensitive
information about SSBAs.
All Health Ministers are signatories to the National Health
Security Agreement (the Agreement).[3] The Agreement supports the operation of the Act
and establishes a framework for a national coordinated response to
public health emergencies. The Agreement also plays an important
role in communicable disease surveillance, both nationally and
internationally. The proposed amendments in the Bill would enable
the Minister for Health and Aging to respond immediately to an
SSBA-related disease outbreak by the suspension of regulatory
requirements and the imposition of new conditions to ensure
protection of public health and safety.[4]
The success of communicable disease control and containment
rests on surveillance underpinned by a robust timely and accurate
reporting system. The proposed amendments clarify the obligations
of entities (such as academic organisations and clinical/diagnostic
organisations) in the early stages of handling suspected SSBAs,
including reporting requirements. The legislation has been amended
to ensure that suspected SSBAs comply with the new SSBA
standards.[5]
In 2007, the Council of Australian Governments (COAG) endorsed
the recommendations of a review into biological agents conducted in
2002. One of the recommendations was to establish a two-tiered list
of SSBAs identified in the review. Regulatory arrangements for Tier
1 commenced 31 January 2009 and from January 2010 for Tier
2.[6]
The Bill was reviewed by the Senate Standing Committee on the
Scrutiny of Bills (the Scrutiny of Bills Committee), with comments
published on 12 August 2009.[7]
The Scrutiny of Bills Committee s comments are referred to in
the relevant parts of the Main Provisions section.
According to the Government, there would be no costs to the
Government associated with the measures proposed in the Bill,
because those measures could be implemented within existing
resources.[8]
According to the regulatory impact analysis conducted by the
Office of Best Practice Regulation (OBPR), the estimated total
costs related to the handling of suspected SSBAs range from $57 834
$112 914 per year.[9]
The OBPR also estimates that there would be little to no
business compliance costs related to other measures proposed in the
Bill, because those measures would either reduce the regulatory
obligations or address legal issues that have no business cost
implications.[10]
Please note that not every proposed amendment will be dealt
with.
Part 1 of the Bill sets out proposed amendments relating to
emergency disease situations.
Item 1 proposes to insert new Division
5A into Part 3 of the Act (Regulation of SSBAs).
Proposed Division 5A contains provisions that
would suspend the usual requirements under Division 5 of Part 3 for
entities handling SSBAs. These usual requirements include reporting
and disposal requirements, as well as compliance with SSBA
Standards.
Proposed new section 60A provides that after
considering relevant advice,[11] where the Minister is satisfied that there is a
threat, involving an SSBA, to one or more of the following:
- the health and safety of people
- the economy, and
- the environment,
the Minister may, by legislative instrument,[12] specify that one or more of the
requirements in Division 5 would not apply for a particular length
of time, in relation to that SSBA, subject to conditions. However,
the Minister must only do so after considering the Secretary s
advice that the making of the legislative instrument would help in
reducing the threat and maintaining sufficient controls for the
security of all SSBAs.
Note that proposed subsections 60A(4)
(5) provide that a legislative instrument made
under this section would, despite section 12 of the Legislative
Instruments Act 2003, take effect either:
- on the day the instrument is made, or
- on a later day as specified in the instrument.
Subsection 12(1) of the Legislative Instruments Act
2003 provides for a legislative instrument generally becoming
effective on or after the day that the instrument is registered on
FRLI, subject to any disadvantage of any rights of or liabilities
being imposed on a person under subsection 12(2).
The Government states that proposed subsections
60A(4) (5) would:
allow the Minister s legislative instrument to
take effect without delay (and before registration on the FRLI) in
order to deal with particular emergency disease situations. For
example, there may be a need to put measures in place immediately
to deal with the extreme threat posed by the spread of an
SSBA-related disease outbreak.[13]
It is noted that the Scrutiny of Bills Committee commented:
While the Committee is cognisant of the need to
deal with emergency disease situations expediently, these
provisions would allow legislative instruments to cover important
matters without having the benefit of scrutiny by the Parliament.
Accordingly, the Committee seeks the Minister s
advice as to how scrutiny of any emergency arrangements is
intended to be provided.[14]
Theses comments apply similarly to proposed subsections
60B(4) and (5) below.
Proposed section 60B provides that the Minister
may (by way of legislative instrument) also vary or revoke such
legislative instrument, on advice from those people whose advice
was considered in making that principal instrument, and only if
satisfied that:
- in the case of a variation: the variation would help reduce the
threat to which the principal instrument relates and maintain
sufficient controls for the security of all SSBAs
- in the case of a revocation:
- the threat, or one of the threats, giving rise to the making of
the principal instrument either no longer exists or is no longer
such that the principal instrument is needed to address the threat,
or
- the Minister is no longer satisfied that the principal
instrument adequately addresses the threat(s) to which that
instrument relates.
As to comments about proposed
subsections 60B(4) and (5), see above
comment.
While it is noted that decisions made under proposed provisions
in Part 1 of the Bill, (relating to emergency powers in the event
of a threat(s) posed by an SSBA-related outbreak) would not be
reviewable decisions for the purposes of section 80 of the Act, it
is important to keep in mind that such situations do require
immediate response to manage the threat(s). Still, in such
circumstances, the Bill does propose certain protections such as
the requirement for the Minister to consider advice, including
expert advice, from particular people; and that any decision by the
Minister would be by legislative instrument which would be open to
parliamentary scrutiny.[15] The Bill also proposes that the Minister would be able
to vary or revoke such legislative instrument in particular
circumstances.
Part 2 of the Bill sets out proposed amendments effectively
extending the regulation of biological agents to those
suspected of being SSBAs on the basis of laboratory
tests.
Existing provisions in the Act relate only to biological agents
known to be SSBAs.
For example, items 8 10 propose to
amend subsections 35(1) (2) of the Act so that the
Minister may also determine standards, by legislative instruments,
relating to biological agents suspected of being SSBAs on the basis
of laboratory tests, which would include requirements relating to
the handling and disposal of such biological agents.
Item 11 proposes to insert new
subsection 35(3A) into the Act, which would provide that
the standards may set out varying requirements relating to a
biological agent, according to whether the biological agent is:
- merely suspected of being an SSBA
- is an SSBA (irrespective of the entity s knowledge or ignorance
of that fact)
- is known by a specific entity to be an SSBA, or
- is known by a specific entity to be an SSBA, having previously
been suspected of being an SSBA on the basis of laboratory
tests.
Item 12 proposes to insert new Division
4A (sections 38A 38Q) into Part 3 of the
Act. Proposed Division 4A sets out provisions
about the principal requirements relating to biological agents
suspected of being SSBAs at the time of initial testing.
For example, proposed section 38B provides
that, within two days (or a longer period of time as allowed by the
Secretary) of becoming suspicious that the biological agent is an
SSBA, the initial tester must either arrange for further
confirmatory testing of the biological agent to be done to
determine whether it is, in fact, an SSBA; or destroy the
biological agent according to the SSBA Standards. However, that
requirement would not apply where the initial tester is a
registered entity in relation to a particular SSBA or all SSBAs in
a particular class of SSBAs; and the initial tester suspected that
the biological agent was either that particular SSBA or included in
the particular class of SSBAs.
Under proposed section 38C, if an entity is
subject to those requirements, failure to comply would be an
offence. The maximum penalty proposed is $55 000.[16]
Proposed section 38D sets out requirements, for
both the initial tester and any entity to whom the initial tester
provides a sample of the suspected SSBA for confirmatory testing,
to comply with SSBA Standards.[17]
In addition, proposed section 38F provides for
reporting obligations of initial testers to the Secretary, where
the initial tester has transferred the biological agent, or sample
thereof, for confirmatory testing to a laboratory other than the
initial testing laboratory; or to another entity. Failure to comply
with those obligations, when required to do so, would be an offence
under proposed section 38G. Again, the maximum
penalty proposed is $55 000.[18]
Under proposed section 38H, the initial tester
must report confirmatory testing results to the Secretary within
two working days of becoming aware of those results (or a longer
period of time as allowed by the Secretary). Failure to do so would
be an offence under proposed section 38J, unless
either the initial tester is a registered entity; or the testing
was done by the initial tester in the initial testing laboratory
and the biological agent was found not to be an SSBA. The maximum
penalty proposed is $55 000.[19]
According to proposed section 38K, if a
biological agent is disposed of within two working days after
confirmatory testing shows that it is an SSBA (or a longer period
of time as approved by the Secretary), the disposal was done in
accordance with the relevant SSBA Standards and the biological
agent had not been included in the National Register prior to
disposal, then there are additional reporting obligations on the
entity. Failure to comply with those obligations, would be an
offence under proposed section 38L, where the
maximum penalty proposed is $55 000.[20]
It is noted that in complying with its obligations under
proposed section 38K, an entity would be exempted
from having to comply with its reporting obligations under section
42 and paragraph 48(1)(a) of the Act. Section 42 of the Act relates
to reporting requirements of entities that handle SSBAs. Paragraph
48(1)(a) provides that it is a reportable event where a registered
entity starts handling, at a particular facility, an SSBA that is
not included in ARTG in relation to both that entity and
facility.
Proposed sections 38M and 38P
contain further provisions relating to destruction of biological
agents.
According to proposed section 38M, where the
biological agent is destroyed before completion of confirmatory
testing, the initial tester must report to the Secretary about the
destruction within two days of the biological agent being destroyed
(or longer as approved by the Secretary). This requirement would
not apply where the initial tester is a registered entity in
relation to a particular SSBA or all SSBAs in a particular class of
SSBAs; and the initial tester suspected that the biological agent
was either that particular SSBA or included in the particular class
of SSBAs.
According to proposed section 38P, where the
initial tester does not have confirmatory testing or destruction of
the biological agent done, pursuant to proposed section
38B (as discussed above), the Secretary could direct the
initial tester to do so within a specified period of time that must
be reasonable in the given circumstances. Note that item
24 proposes that this decision would be a reviewable
decision under section 80 of the Act.
Failure to comply with an obligation or a direction under
proposed sections 38M and 38P
respectively would constitute an offence under proposed
sections 38N and 38Q respectively, where
the maximum penalty proposed is $55 000.[21]
Items 15 and 16 propose
amendments taking into account that the new emergency disease
provisions in Part 1 of the Bill are expected to commence before
the provisions dealing with suspected SSBAs in Part 2. These items
propose to change the heading of Division 5A and
insert new subsection 60A(1A).
In particular, proposed new subsection
60A(1A) would give discretionary power to the Minister to
make a legislative instrument specifying that proposed
Division 4A (or part thereof) and/or proposed
section 38D (as it relates to specific SSBA Standards)
would not apply for a specific period of time in relation to one or
more biological agents suspected of being an SSBA, subject to any
specified conditions.
Part 3 of the Bill contains proposed amendments relating to
inspectors powers under the Act. It is noted that inspectors
already have powers to monitor compliance with SSBA requirements
under the Act.[22]
The amendments proposed in the Bill relate to new inspectors powers
to obtain and exercise offence-related warrants.
Item 32 proposes to replace section
70 of the Act and insert new sections 70A
70P into the Act. Currently, section 70 does not provide
for search and seizure powers under an offence-related warrant. The
Explanatory Memorandum states that if such warrants are required,
inspectors must refer the matter to the relevant authority for
investigation, thereby impeding timely investigation.[23]
Proposed section 70 would enable an inspector
to enter premises and exercise certain offence-related powers under
proposed section 70A (see below) if the inspector
has reasonable grounds to suspect that there may be evidence,
relating to either a suspected or possible future offence, on the
premises. However, the inspector can only do so if:
- the occupier of the premises consents and the inspector shows
his or her identity card as required by the occupier, or
- entry is made under an offence-related warrant.[24]
Proposed section 70A sets out the inspectors
offence-related powers. These include:
- powers of entry by occupier s consent to search premises and
anything on the premises for evidence that the inspector reasonably
suspects may be on the premises
- powers of entry by offence- related warrant to search premises
and anything on the premises for the kind of evidence specified in
the warrant, and, if the inspector finds that kind of evidence,
power to seize it
- to inspect, examine, measure, conduct tests on or take samples
of such evidence
- to make any still or moving image; or any recording of the
premises or such evidence
- to take equipment onto the premises for the purposes of
exercising powers relating to the premises
- certain powers to operate electronic equipment on the
premises
- certain powers relating to obtaining evidence, such as seizing
equipment and disk, tape or other storage device; operating
electronic equipment on the premises to put evidence into
documentary form and to remove such documents from the premise;
operating electronic equipment on the premises to transfer evidence
onto tape, disk or other storage device which can be taken off the
premises, and
- entry by warrant seizing other material reasonably considered
as evidence where the inspector reasonably believes that it is
necessary to seize it to prevent its concealment, loss or
destruction.
Proposed section 70B would enable other people
to assist inspectors to enter premises and exercise offence-related
powers where such assistance is reasonable and necessary; and only
according to the inspector s directions.
Proposed section 70C would enable an inspector
to use such force, as is necessary and reasonable in the
circumstances, against people and things; and a person assisting
the inspector to use such force, as necessary and reasonable in the
circumstance, against only things.
Proposed section 70D would enable an inspector
to require certain answers to questions asked, and seek production
of documents sought, by occupiers of the premises or anyone on the
premises, depending on whether entry was authorised by the occupier
or made under a warrant. The questions and documents to be produced
must relate to the reasons for entry into the premises. Failure to
comply constitutes an offence.
It is noted, however, that existing section 79 of the Act
provides:
Nothing in this Division affects the right of a
person to refuse to answer a question, give information, or produce
a document, on the ground that the answer to the question, the
information, or the production of the document, might tend to
incriminate him or her or make him or her liable to a penalty.
Thus no proposed section 70D offence would occur if, under the
relevant situation, a person was covered by section 79.
Proposed section 70E requires the inspector to
have the warrant, or a copy thereof, in his or her possession, when
entering premises under a warrant and exercising powers in relation
to things on those premises as specified by the warrant.
Proposed section 70F requires the occupier of
premises, or someone else apparently representing the occupier, to
assist the inspector and anyone assisting the inspector with all
reasonable facilities and assistance so that they may effectively
exercise their powers. Failure to do so would be an offence.
Proposed section 70G requires the inspector, in
executing a warrant and seizing documents, computer files or
anything else that is; or a storage device containing information
which can be; readily copied, to provide copies thereof if
requested by the occupier of the premises; or anyone else who is
present on the premises when the warrant is executed and who
apparently represents the occupier. This requirement would not
apply if it is a Commonwealth offence for the occupier or other
person to possess the document, computer file, thing or
information.
According to proposed section 70H, where an
object is seized under Subdivision C of Division 7 of Part 3 of the
Act, the inspector must provide a receipt for that object. A
receipt may cover two or more objects seized.
Proposed section 70J provides that, in general,
the Secretary must take reasonable steps to return objects seized
under Subdivision C of Division 7 of Part 3 of the Act if whichever
of the following occurs first:
- the reason for seizure no longer exists, or
- 60 days have passed after seizure.
This requirement is subject to any contrary court order. In
addition, the requirement would not apply if the seized object is
forfeited or forfeitable to the Commonwealth; or is the subject of
an ownership dispute.
However, once 60 days have passed, the Secretary would not have
to return objects seized in any of the following situations:
- proceedings have commenced within the 60 day period and are not
completed, in which the object(s) seized may be used as
evidence
- an order has been made by a magistrate permitting the object(s)
to be retained under proposed section 70K (see
below)
- the Commonwealth, Secretary or inspector is lawfully authorised
to retain, destroy, dispose of or otherwise deal with the
object(s), and
- if returning the object(s) could cause imminent risk of death;
serious illness, injury or environmental damage.
Objects that must be returned under proposed section
70J, must be returned to either the person from whom the
object was seized (if that person is entitled) or otherwise, to the
owner.
Proposed section 70K contains provisions
enabling a magistrate to make an order that an object be retained
for an additional period, not exceeding three years. When deciding
whether to make such an order, the magistrate must be satisfied
that the object should be retained for the purposes of:
- investigating whether an offence has been committed against the
Act, the Crimes Act 1914or the Criminal Code
relating to this Act, or
- securing evidence of such offence for the purposes of
prosecution.[25]
The inspector may apply for such an order where proceedings, in
which the object(s) may be used as evidence, have not commenced,
either before the end of:
- 60 days after the object was seized, or
- a period of time previously specified in a magistrate s order
under this provision.
However, before making such application, the inspector must
have:
- taken reasonable steps to find out who has an interest in
retention of the object(s), and
- where practicable, notified everyone whom the inspector
believes would have an interest in the application.
Proposed section 70L provides that if, despite
reasonable efforts to find the person to whom the object should be
returned, that person cannot be found or that person refuses to
take possession of the object(s), the Secretary may appropriately
dispose of the object.
It is noted that the Bill also proposes that if disposal of an
object under this section results in an acquisition of property
from someone otherwise than on just terms, the Commonwealth must
pay a reasonable amount of compensation to that person. In a
dispute over the compensation amount, the person may commence
Federal Court proceedings to determine what would be reasonable
amount of compensation.
Section 51(xxxi) of the Constitution
provides that:
The Parliament shall, subject to
this Constitution, have power to make laws for the peace, order,
and good government of the Commonwealth with respect to:
the acquisition of property on just
terms from any State or person for any purpose in respect of which
the Parliament has power to make laws;
Section 51(xxxi) effectively ensures
that all Commonwealth laws relating to the acquisition of property
must provide just terms to people whose property has been
compulsorily acquired. Such laws failing to provide as such would
be invalid.
Proposed sections 70M and 70N
generally provide for process, issue and contents requirements of
offence-related warrants, including by telephone, fax or other
electronic means.
Item 34 proposes to replace sections
75 and 76 in the Act.
Proposed section 75 extends the consent
requirements in the Act. Where entry is by consent only and not in
respect of a warrant, in addition to the requirements of informing
the occupier that he or she may refuse consent and that consent
must be voluntary, it is provided that:
- consent may be limited to a particular period of time but may
be withdrawn before that time expires
- otherwise, consent is effective until it is withdrawn, and
- when consent ceases, the inspector and anyone assisting him or
her must leave the premises.
Proposed section 76 provides that the inspector
must give certain details of the warrant to the occupier; or a
person who apparently represents the occupier and who is at the
premises, when executing a monitoring or offence-related
warrant.
Items 36 and 37 relate to a
new entry requirement the inspector must show his or her identity
card to the occupier of the premises or another person apparently
representing the occupier.
Item 39 proposes to insert new section
79A into the Act, relating to compensation for damage to
electronic equipment operated pursuant to sections 67 (monitoring
powers) or 70A (offence-related powers). If damage, as specified in
this provision, occurs because of:
- insufficient care in choosing who would operate the equipment,
or
- insufficient care by the person who operated the
equipment,
the Commonwealth must pay, to the owner of the equipment or the
user of the data and programs, such reasonable compensation as
agreed. In the event of a dispute about the amount of compensation,
the owner or user may commence proceedings in the Federal Court or
the Federal Magistrates Court to have that dispute resolved. In
determining that question of reasonable compensation, the Court
must consider whether there was appropriate warning or guidance
regarding the operation of the equipment given by the occupier of
the premises or the occupier s employees and agents available at
the time.
It is noted that inspectors under the Act are not law
enforcement officers. However, the Government explains that:
It is recognised that exceptional circumstances
should exist before granting non-law enforcement personnel (such as
inspectors under the NHS Act) with the significant powers
associated with offence-related warrants. It is considered that
such exceptional circumstances exist in this case because:
- the biological agents that are the subject of this legislation
are, by their nature, highly dangerous. For example,
Ebolavirus and Foot-and-mouth disease virus;
- there are very significant security issues that arise from
breaches of the SSBA regulatory scheme; and
any breaches have the potential to cause
extensive damage to public health and safety, the environment and
the economy.
It is proposed that the services of inspectors
appointed under the Gene Technology Act 2000 will be
retained for the purposes of the NHS Act. These inspectors already
exercise powers related to offence related-warrants under the
Gene Technology Act 2000 and are experienced in cautiously
and appropriately exercising such powers. To further ensure that
the powers are exercised with care, the Department of Health and
Ageing will develop an internal governance framework for
inspections made under the SSBA regulatory scheme addressing issues
relating to accountability, training, resources and risk management
strategies.[26]
While it is acknowledged that where such powers are conferred to
non-law enforcement officers, it is important that there be
processes built in to ensure proper accountability for the exercise
of these powers, it is noted such processes have, in fact, been
built into the Act and Bill.[27] For example, it is noted that under subsections
63(1) and(3) of the Act itself, anyone appointed by the Secretary,
in writing, as an inspector must be a person who is appointed or
employed by the Commonwealth, and whom the Secretary is satisfied
has appropriate experience and skills. Under subsection 63(2) of
the Act, an inspector must comply with any directions by the
Secretary when performing functions or exercising powers under the
Act. Another example is that, in such circumstances, inspectors are
and would be would continue to be required to show his or her
identity card to occupiers of premises.
It is also noted that there do not appear to be provisions
specifically about challenging the exercise of inspectors powers in
the Bill.[28]
However, this may be explained by reference to the context in which
such inspections would occur highly dangerous biological agents
with potential for extensive damage to public health and safety in
the event of a breach of the SSBA regulatory scheme. It is also
noted that the Government has stated that DoHA will develop and
internal guidance framework for such inspections, which will
address such matters as accountability and risk management
strategies (see above). The contents of such internal guidance
framework would be useful in any determinative analysis of the
inspectors powers proposed in the Bill.
As long as processes for accountability are included into the
legislation, such provisions may be considered acceptable.[29]
Part 4 of the Bill contains provisions relating to reporting of
certain reportable events to the police, and reporting to the
Secretary when there have been no reportable events.
Item 43 proposes to insert new sections
48A and 48B into the Act.
Proposed section 48A will apply when an SSBA
included on the National Register and relating to an entity and
facility in a state or territory is either lost or stolen; or
another reportable event occurs as prescribed by the regulations
for the purposes of this proposed provision. The registered entity
must give police a report of that event within a prescribed period
of time.
Proposed section 48B provides that failure to
comply with that requirement, when required to do so, would
constitute an offence.
Item 51 proposes to insert new
paragraph 48(1)(i) into the Act, which would require a
registered entity to report to the Secretary that there have been
no reportable events which are prescribed by the regulations as
described in paragraph 48(1)(h) of the Act.
Part 5 of the Bill contains provisions to enable the Secretary
to cancel a registered entity s registration or the registration of
one or more of its facilities, on application by that registered
entity, in certain circumstances.
Item 53 proposes to insert new section
55A into the Act.
Proposed section 55A provides that a registered
entity may apply for cancellation of its registration relating to
either all SSBAs for which the entity is registered (total
cancellation) or to one or more specified facilities (facility
cancellation). In deciding whether to approve such application, the
Secretary must be satisfied that the entity (total cancellation),
or the entity at specified facilities (facility cancellation), does
not handle any SSBA included in the National Register relating to
that entity and a facility; or specified facilities as the case may
be.
Proposed subsection 55A(4) relates to
notification requirements placed on the Secretary when cancelling
an entity s registration. However, proposed subsection
55A(5) provides that the validity of such decision is not
affected by failure to comply with those requirements.
It is noted that the Government does not explain the purpose of
that provision in its Explanatory Memorandum.
The Scrutiny of Bills Committee commented, in relation to
proposed subsection 55A(5), that such provision has the potential
to allow for an entity s obligations to be changed without notice
or opportunity for review; and requested that the Government
provide an explanation for proposed subsection
55A(5).[30]
Item 54 proposes to amend section 80 of the
Act, to the effect that the Secretary s decision to refuse the
entity s application to cancel its registration would be a
reviewable decision.
Item 55 proposes to amend the
definition of biological agents in subsection 3(1) of the
Act so that the definition would no longer be limited to bacteria
and viruses that can spread rapidly. This means that the Act could
cover more potentially dangerous biological agents.
Concluding comments
Subject to the concerns expressed above, it appears that:
- the proposed amendments would safeguard public health and
ensure the appropriate handling of SSBAs, suspected or identified,
and
- the proposed amendments, which include built-in protections,
would also strengthen investigative powers and reporting
requirements, which further protect Australians from the potential
misuse of SSBAs.
Members, Senators and Parliamentary staff can obtain further
information from the Parliamentary Library on (02) 6277 2442.
[9]. Explanatory
Memorandum, pp. 4 5. In general, under the Act, handling an SSBA
includes: receiving, holding, using and storing the SSBA, as well
as any operation incidental to, or arising out of, any of those
operations : National Health Security Act 2007 section 3.
However, the meaning of handling an SSBA is subject to National
Health Security Act 2007 section 3 (notes 1 and 2 of the
definition of handling ) and subsection 39(2).
Rebecca de Boer
Sharon Scully
14 August 2009
Bills Digest Service
Parliamentary Library
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