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National Health Security Amendment Bill 2009

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2008-2009

 

 

 

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

 

 

 

 

HOUSE OF REPRESENTATIVES

 

 

 

 

 

 

 

 

 

 

 

 

NATIONAL HEALTH SECURITY AMENDMENT BILL 2009

 

 

 

 

 

EXPLANATORY MEMORANDUM

 

 

 

 

 

 

 

 

 

 

 

 

 

(Circulated by authority of the Minister for Health and Ageing, the Hon. Nicola Roxon MP)





NATIONAL HEALTH SECURITY AMENDMENT BILL 2009

 

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 and Ageing to determine a list of SSBAs.  This list is available on the website of the Department of Health and Ageing at http://www.health.gov.au/ssba#list ;

·          provides for the making of legally enforceable standards for the secure handling of 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;

·          includes powers for monitoring compliance with the regulatory scheme through an inspection regime.

 

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.  This Bill addresses the issues identified in those consultations.  To enhance the effectiveness of the SSBA regulatory scheme, the Bill:

·          introduces new provisions to enable the Minister for Health and Ageing, 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 (refer Part 1 of the Bill);

·          establishes new controls relating to the handling of biological agents suspected of being SSBAs (to complement existing provisions relating to controls on known SSBAs) (refer Part 2 of the Bill);

·          provides for additional search and seizure powers to bring the powers in line with those exercised by other regulatory bodies such as the Gene Technology Regulator (refer Part 3 of the Bill);

·          addresses minor, practical issues such as including new requirements to report certain SSBA-related events to local police forces; clarifying the reporting obligations of registered entities; enabling the Secretary to cancel registration of an entity, on request, where that entity no longer handles SSBAs; and amending the definition of ‘biological agents’ to prevent it being unnecessarily limiting (refer Parts 4 - 6 of the Bill).

 

FINANCIAL IMPACT STATEMENT

 

The financial impact is nil because these measures enhance an existing regulatory scheme and can be implemented within existing resources.

 



REGULATION IMPACT STATEMENT

 

The Office of Best Practice Regulation (OBPR) has agreed that the costs assessment set out below provides sufficient regulatory impact analysis of the proposed measures.  In summary, a Business Costs Calculator report has been prepared in relation to the proposed measure to regulate suspected SSBAs (refer below).  The other proposed measures had no or low business compliance costs and did not require further regulatory impact analysis.

 

Proposed measure to regulate handling of suspected SSBAs—Business Costs Calculator Report

 

Overview

 

Problem being addressed

A majority of entities that will handle a security-sensitive biological agent (SSBA) start off by handling an agent that is positively identified by a presumptive test result.  Because the regulatory obligations of the NHS Act apply only when an entity handles a confirmed SSBA, not regulating suspected SSBAs has been identified as a gap or oversight in the regulatory scheme. 

 

It is currently standard practice for laboratories which find a suspected biological agent in their normal test procedures to go on to confirm the status of the biological agent.  All SSBAs on the List of SSBAs would be confirmed as a matter of course in most laboratories because of either public health or animal health reasons.  In relation to the influenza virus, because of its pandemic potential global health initiatives will require its confirmation.  Therefore, the proposed measure does not substantially change standard practice for clinical/diagnostic laboratories. 

 

What regulation is already in place? 

There is no regulation currently in place for this specific purpose. 

 

What are the objectives?

The proposed measure to regulate handling a suspected SSBA will close a loophole in existing legislation and clarify when the controls in the NHS Act apply to an entity’s handling of an SSBA.  The proposed measure requires that if an entity in its normal testing procedures finds an SSBA from a presumptive test, that entity must either destroy the suspected SSBA or undertake confirmatory testing of the agent.

 

Why is government action needed?

Legislative amendments will clarify when regulatory obligations apply to an entity’s handling of an SSBA. 

 

Feedback / comments from consultation

In providing comments on the draft National Health Security Regulations (NHS Regulations) stakeholders were concerned that the NHS Regulations had not dealt with regulation of suspected SSBAs. 

 



Regulatory Impact Analysis  

 

Approach

This analysis was undertaken using the different cost categories in the Guidance Notes to the Business Cost Calculator (BCC) hosted on the website of the OBPR.  The business compliance costs were based on the person responsible for performing the compliance task.  The time taken to perform the tasks was estimated to be increased if an entity were unable to perform confirmatory tests at its own facility.  If a sample were to be sent away to another entity for confirmation those costs were estimated to double the business costs.

 

The business costs were calculated for each of the above types of business in respect of two options relating to the number of times that the activity or compliance task is expected to be performed in a year.  The activity or compliance task is the number of times that an entity would be expected to find a suspected SSBA in its normal testing procedures.

 

Number of affected businesses

Information obtained from a self identified survey conducted in 2008 indicated that 67 entities would be handling SSBAs.  Of that number:

·                 22 are academic organisations;

·                 35 are clinical/diagnostic organisations;

·                 2 are government agencies;

·                 7 are industrial/commercial organisations; and

·                 1 is a water quality testing laboratory.

 

Academic organisations will not be affected as they generally handle only confirmed SSBA for their research purposes.  The industrial/commercial organisations are also not expected to be affected because in producing pharmaceutical products, they would need to know with certainty the biological agent that they handle.

 

The remaining 38 laboratories are expected to include 18 diagnostic laboratories which may detect suspected SSBA but are unable to perform their own confirmatory tests.  A further 9 businesses are reference laboratories which are expected to receive requests for confirmatory tests on suspected SSBAs from the 18 diagnostic laboratories.  These 27 businesses will be impacted by the proposed reporting requirements for suspected SSBAs.

 

The remaining 11 businesses are expected to be registered to handle SSBAs and to undertake their own confirmatory testing for any SSBAs that they handle.  These businesses will operate under the reporting requirements already provided in the NHS Act and will not be impacted by the proposed new measure.

 

Since commencement of the SSBA Regulatory Scheme in January 2009, the number of entities that have formally registered with the Secretary has not matched the survey results.  However, given that the best information on the number of potentially affected businesses comes from the self-identified survey, these results have been used in this costing.  

 

The size of each of the organisations has not been assessed because such information was not publicly available for all organisations.  All entities have therefore been classified as large (employing 200 or more workers) in accordance with OBPR guidelines.

 



Costs

The potential compliance costs relate to the requirement to report that a suspected SSBA that is identified by an entity’s normal testing procedures, has been sent for confirmatory testing or destroyed.  If the entity chooses to carry out confirmatory testing at another laboratory they will be required to report the transfer of the suspected SSBA sample.  If the entity chooses to destroy the suspected SSBA, they will need to report the destruction.  

 

It is expected that the compliance tasks will be performed by a Responsible Officer (RO) or Deputy who are required to be appointed by the SSBA Standards.  The RO’s salary has been estimated to be $100, 000 per annum with normal work hours estimated to be 75 hours per fortnight.  This equates to a wage of approximately $51 per hour.  

 

The cost categories that are applicable include:

 

·                 Notification - An entity that identifies a suspected SSBA will be required to either carry out confirmatory testing or destroy the agent.  If the entity has to send the sample away for confirmation, it will have to report matters related to the transfer and the final results.  If the entity chooses to destroy the suspected SSBA, they will need to report the destruction.  The notification costs were estimated on an ongoing basis;   

 

·                 Record Keeping - The proposed measure will mean that records are required to be kept about suspected SSBAs.  Because record keeping systems will already be in place (to enable entities to comply with the existing NHS Regulations), it is not expected that additional record keeping relating to the suspected SSBA will need to be established.  It is therefore expected that there will be limited set-up costs and only small ongoing notification and record keeping costs:

 

-           If an entity were able to perform confirmatory testing at its own facility, the record keeping and notification costs would be estimated to take an hour of the RO’s time;

 

-           It is expected that 18 entities will need to send a sample to another entity for confirmatory tests.  In that situation it is expected that the transferring entities will have compliance costs for recording keeping and notification equivalent to two hours of the ROs time at the transferring entity.  An RO at the transferring facility will need to report that they will carry out confirmatory testing and if they transfer the suspected SSBAs, there are also reporting requirements.  An entity that chooses to destroy the suspected SSBA will also need to report.  Whether an entity chooses to carry out confirmatory testing or destruction, the notification and record keeping costs are expected to be the same  - approximately two hours of an RO’s time; and

 

·                 Education - This cost category involves maintaining awareness of legislation and regulations, and the costs of keeping abreast of changes to regulatory details.  For example, businesses are required to spend time educating staff about changes to regulation.  This involves time to obtain new legislation, examining regulation, and communicating the effects.  It is anticipated that entities would incur these costs in complying with the proposed new regulation of suspected SSBAs.  The education costs are expected to be at start up.  This compliance task is estimated to take two hours of the RO’s time in attending information sessions and communicating the effects of the new measure to the entity’s staff. 

 

Number of times of activity per year

Given the different fields and types of clinical/diagnostic organisations, it is estimated that on average an entity could handle a suspected SSBA some 20 to 40 times a year.  The cost calculations have been developed using the number of times a suspected SSBA is found at an entity.

 

Development of Costs calculations

The following calculations are based on the above compliance costs.  Costings are made on a low or high estimate of the number of times that the entity handles a suspected SSBA per year.  Eighteen entities will need to report handling and transfer of suspected SSBAs and 9 entities will need to report receipt of suspected SSBAs.  The costings reflect ongoing costs for the first year.

 

Costings 1 - The first calculation assumes that the affected entities will handle a suspected SSBA 20 times a year. 

 

Type

Cost per business

Total cost (for 27 businesses)

Start-up

$   102

$  2 754

Ongoing

$2 040

$55 080

Total cost for first year

$2 142

$57 834

 

Costings 2 - The second calculation assumes that the affected entities will handle a suspected SSBA 40 times a year. 

 

Type

Cost per business

Total cost (for 27 businesses)

Start-up

$   102

$    2 754

Ongoing

$4 080

$110 160

Total cost for first year

$4 182

$112 914

 

Uncertainties

The cost calculations are well informed but an estimate only.  In particular, the estimates of entities that are not able to perform confirmatory tests at their own facilities and the number of times that an entity will handle suspected SSBA are uncertain. 

 

Cost impacts of other proposed measures

 

The other proposed amendments to the NHS Act (relating to emergency disease situations, additional search and seizure powers, changes to reporting requirements, capacity to cancel an entities registration and changes to the definition of biological agents) have little to no business compliance costs.  This is because they either reduce regulatory obligations or address legal issues that have no implications for business costs.



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 2009 .

 

Clause 2 - Commencement

This clause provides for the commencement of each of the provisions in the Bill.  Broadly, the proposed measures relating to emergency disease situations and additional inspector powers will commence the day after Royal Assent.

 

The remaining measures will commence on a day to be fixed by proclamation.  The later commencement is to enable further operational detail to be developed in regulations or by making consequential changes to other legislative instruments.  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 - EMERGENCY DISEASE SITUATIONS

 

Outline

The Council of Australian Governments Report on the Regulation and Control of Biological Agents recommended that regulation of the handling of SSBAs should be sufficiently flexible so as not to impede diagnosis and treatment in the event of a disease outbreak caused by an SSBA.  The purpose of the amendments in this Part is to enable the Minister to deal with emergency disease situations by relaxing some or all of the regulatory obligations in the NHS Act, while ensuring that sufficient security controls are maintained.  The Minister will be able to do so by a legislative instrument, which may be varied or revoked.

 

The Minister will be advised by experts including the Commonwealth Chief Medical Officer, the Commonwealth Chief Veterinary Officer, the Secretary to the Department of Health and Ageing and any other person whom the Minister believes has scientific or technical knowledge in relation to SSBAs. 

 

Given the wide range of scenarios that may arise, it is important that the Minister is able to specify conditions to ensure that adequate controls are maintained in handling all SSBAs for which standard regulatory obligations have been suspended.  The amendments also establish an offence for failing to comply with any conditions specified in the legislative instrument. 

 



Item 1

This item inserts new Division 5A that provides for the regulatory scheme’s response to deal with the threats that may be caused by an SSBA.  

 

Section 60A - Minister may suspend Division 5 to deal with threats

 

This section enables the Minister to specify, by legislative instrument, that certain regulatory obligations in Division 5 or section 56, relating to specified provisions of the SSBA Standards, do not apply.  The Minister may make a legislative instrument to this effect only if the Minister is satisfied of two principal matters:

·          that there is a threat involving the agent to the health or safety of people, the economy or the environment; and

·          that the making of the legislative instrument would help to reduce the threat and maintain adequate controls for the security of all SSBAs.

 

In being satisfied of the first matter, the Minister must consider advice from the Commonwealth Chief Medical Officer, the Commonwealth Chief Veterinary Officer and any other person who the Minister believes has scientific or technical knowledge in relation to SSBAs.  

 

In being satisfied of the second matter, the Minister must consider advice from the Secretary to the Department of Health and Ageing.  

 

The extreme nature of a threat posed by an SSBA-related disease outbreak warrants the delegation of legislative power to ensure that an appropriate and immediate response can be made to the challenge of safeguarding public health and safety in an emergency disease situation.  The section puts appropriate limits on this power by prescribing the extraordinary circumstances in which the power may be exercised.

 

Section 60A also enables the Minister to stipulate certain conditions associated with the suspension of the usual regulatory obligations.  The NHS Act is unable to provide for the conditions that may be specified in the legislative instrument because it is not possible to predict the different scenarios that an emergency disease situation might present.  The type and context of the emergency will determine what conditions would be appropriate to be set in the instrument in order to provide an appropriate public health and security response. 

 

Subsection 60A(4) provides for the legislative instrument to take effect on the day on which the instrument is made or if the instrument specifies a later day, on that day.  Subsection 60A(5) provides that this is to be the case despite section 12 of the Legislative Instruments Act 200 3 which provides for instruments to take effect immediately following registration on the Federal Register of Legislative Instruments (FRLI).  The effect of this is to 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.   

Section 60B - Variation or revocation of suspension

 

This section enables the Minister, by legislative instrument, to vary or revoke the legislative instrument made under new subsection 60A(1) (the principal instrument). 



The preconditions for variation of the principal instrument are:

·          the Minister must have considered advice from the persons whose advice was considered for the purposes of making the principal instrument; and

·          the Minister must be satisfied that the principal instrument as varied would help to reduce the threat addressed by the principal instrument and maintain adequate controls for the security of all SSBAs.  

 

The preconditions for revocation of the principal instrument are that the Minister, after considering further advice from the persons whose advice was considered for the purposes of making the principal instrument:

·          is satisfied that the threat addressed by the principal instrument no longer exists or is no longer such as to require the principal instrument to be in force; or

·          is no longer satisfied that the principal instrument adequately addresses the threat, or one of the threats.

 

The variation or revocation takes effect in the manner set out in the legislative instrument and the Minister’s legislative instrument will override section 12 of the Legislative Instruments Act 2003 (which provides that if the instrument does not specify when its provisions will commence, it commences the first moment of the day after it is registered on the FRLI).  This is necessary because there may be cases where there is a need to vary or revoke the legislative instrument immediately to deal with an increase in threat posed by the spread of an SSBA-related disease outbreak (rather than waiting for registration on FRLI).   

Section 60C - Offence failure to comply with conditions on suspension

 

Section 60C establishes an offence where a person fails to comply with conditions specified in a legislative instrument made under this Division. 

 

A maximum penalty of 500 penalty units may be imposed.  This equates to $55,000 for an individual and $275,000 for a body corporate (see subsections 4AA(1) and 4B(3) of the Crimes Act 1914 ).  This penalty is consistent with other offence provisions in Part 3 of the NHS Act and is set at a level needed to maintain general deterrence as a safeguard against risks to public health and safety. 

 

PART 2 - SUSPECTED SECURITY-SENSITIVE BIOLOGICAL AGENTS

 

Outline

The amendments described in this Part relate to the regulation of biological agents suspected of being SSBAs on the basis of testing in a laboratory (suspected SSBA).  These amendments address regulation of the early stages of handling a biological agent when, having performed all of an entity's usual testing procedures in a laboratory for that biological agent, there is a positive presumptive identification of an SSBA.  On the basis of that testing, the tester is taken to form a reasonable suspicion (but is not certain) that the biological agent is an SSBA. 

 

The new provisions require that within two business days of forming the suspicion, or such longer period allowed by the Secretary, an entity must undertake confirmatory testing or destroy all of the suspected SSBA in accordance with the SSBA Standards.  During that time, the entity must comply with proposed new standards for handling suspected SSBAs.

 

If the entity chooses to carry out confirmatory testing, it will be required to report if the suspected SSBA is transferred to another facility or entity for the purposes of confirmation and the results of the confirmatory test.  If the entity chooses to destroy the agent, it will be required to report that destruction within two business days after the destruction (or such longer period allowed by the Secretary).

 

A registered entity that forms a reasonable suspicion that the suspected SSBA may be the confirmed SSBA for which it is already registered, is exempt from the requirement to carry out confirmatory testing or destruction.  An unregistered entity that forms a reasonable suspicion and proceeds with confirmatory tests in the initial testing laboratory is exempt from reporting a negative confirmatory test result. 

 

The Minister will be able to determine new standards for handling suspected SSBAs.  Consistent with the current enforcement regime, offences are also proposed for contravention of the requirements. 

 

Items 2 and 3

These items make consequential changes to the definition of dispose of and handling so that the definitions apply to both suspected and known SSBAs.  This is achieved by omitting the words ‘security-sensitive’ wherever they occur within these definitions.  

 

Item 4

This item repeals note 1 at the end of the definition of handling at subsection 3(1).  This is not a substantive change but simply clarifies that subsection 39(2) affects when an entity is treated for the purposes of Division 5, Part 3 as handling an SSBA that is a toxin.

 

Item 5

This item inserts a new definition within subsection 3(1) for sample of a biological agent.  A sample of a biological agent includes a subculture of the agent and a preparation made from the agent.  These words are used in the new requirements relating to suspected SSBAs (see new Division 4A) when an entity arranges with another entity to carry out confirmatory testing using a sample of the biological agent. 

 

Items 6 and 7

Section 30 details the objects of Part 3 of the NHS Act which relates to the regulation of SSBA.  These items amend this section so that the objects of Part 3 extend to biological agents suspected on the basis of testing in a laboratory of being SSBA.

 

Items 8 to 11

These items amend section 35 which enables the Minister to determine standards relating to SSBAs.  The amendments made by these items enable the Minister to make standards relating to suspected SSBAs. 

 

Item 9 adds two notes to inform readers of the new SSBA Standards relating to suspected SSBAs, and that compliance with the SSBA Standards is required by section 56.

 

The amendment made by item 10 enables the Minister to make standards that may set out requirements relating to handling (including transport) of suspected SSBAs or the disposal of biological agents that are SSBAs and were previously suspected on the basis of testing in a laboratory of being SSBAs. 



Item 11 inserts new subsection 35(3A) to provide that a standard may set out different requirements relating to a biological agent depending on the various states of knowledge by an entity about the biological agent.  The new subsection (3A) provides flexibility to support new standards that will address the different situations when entities handle suspected SSBAs.

 

Item 12

This item inserts new Division 4A after Division 4 of Part 3.  The new Division 4A deals with requirements relating to suspected SSBAs, and inserts:

·          Subdivision A that deals with the application of the new Division 4A;

·          Subdivision B that deals with carrying out confirmatory testing or destruction;

·          Subdivision C that deals with compliance with SSBA Standards;

·          Subdivision D that deals with further provisions for confirmatory testing; and

·          Subdivision E that deals with further provisions relating to destruction. 

 

Division 4A - Requirements relating to suspected security-sensitive biological agents

 

Subdivision A - Application

Section 38A - Application of Division

 

Section 38A provides that the Division applies:

·          if an entity (the initial tester) that operates a laboratory has tested a biological agent in that laboratory (the initial testing laboratory) to determine the identity of the biological agent; and

·          on the basis of that testing, the initial tester forms a reasonable suspicion (but is not certain) that the biological agent is an SSBA.

 

It is usual for an entity to perform a few presumptive tests to identify a biological agent.  The measure is aimed at the positive presumptive result following all the usual or normal tests that have been undertaken by that type of testing laboratory.  For example, the usual testing procedures of a food laboratory would be to test for a food-related SSBA outbreak such as botulinum toxin but not Bacillus anthracis (anthrax) which affects humans and animals.

 

Generally, the measure is not meant to capture:

·          an ‘all hazards’ approach where there is a suspicion that a white powder sent in the post may contain Bacillus anthracis spores; or

·          hand held testing equipment that has poor specificity or sensitivity.

 

Subdivision B - Carrying out confirmatory testing or destruction

Section 38B - Initial tester must have confirmatory testing or destruction done

 

This section requires that within two business days after forming the suspicion (or such longer period as the Secretary allows) the initial tester must:

·          arrange to carry out confirmatory testing (by the initial tester or another entity) of the biological agent to determine whether the biological agent is an SSBA; or

·          destroy the biological agent in accordance with the SSBA Standards.  

 

The exception to this requirement is if the initial tester’s suspicion is that the biological agent is a particular SSBA, or is included in a class of SSBAs, that the entity is already registered to handle.

 

A note informs readers that in a prosecution of an offence against section 38C, the defendant bears an evidential burden in relation to whether the exception applies (by the application of subsection 13.3(3) of the Criminal Code which provides that a defendant who wishes to rely on any exception or exemption provided by the law creating an offence bears an evidential burden in relation to that matter).  Given that inappropriate handling of an SSBA has potential to cause extreme damage to public health and safety and the environment, and that an initial tester would be in an exclusive position to know if an agent is likely to be an SSBA, an initial tester (as a defendant) should bear an evidential burden of relying on the exemptions provided in the section.

 

Section 38C - Offence failure to have confirmatory testing or destruction done

 

Section 38C establishes an offence for contravention of the requirements in new section 38B relating to failure to have confirmatory testing or destruction done. 

 

A maximum penalty of 500 penalty units may be imposed.  This equates to $55,000 for an individual and $275,000 for a body corporate (see subsections 4AA(1) and 4B(3) of the Crimes Act 1914 ).  This is consistent with other offence provisions in Part 3 of the NHS Act and is set at a level needed to maintain general deterrence as a safeguard against risks to public health and safety. 

 

Section 4K of the Crimes Act 1914 does not apply to the offence.  This means that the offence is not committed on a daily or continuing basis.

 

Subdivision C - Compliance with SSBA Standards

 

Section 38D - Compliance with SSBA Standards in handling biological agent

 

This section requires the initial tester to comply with the SSBA Standards in relation to their handling or disposal of the biological agent in the period starting when they have formed the suspicion and ending at the earlier of:

·          the time when the initial tester obtains the confirmatory testing results; or

·          the time when destruction of the biological agent is completed. 

 

The entity that is provided with a sample of the biological agent for confirmatory testing must also comply with the SSBA Standards in relation to their handling and disposal of the sample and of any biological agent included in or derived from the sample.  The entity must comply with the SSBA Standards in the period starting when they have been provided with the sample and ending when the entity obtains the confirmatory testing results.  

 

Section 38E - Offence failure to comply with SSBA Standards in handling biological agent

 

Section 38E establishes an offence for failure to comply with new section 38D. 

 

A maximum penalty of 500 penalty units may be imposed.  This equates to $55,000 for an individual and $275,000 for a body corporate (see subsection 4AA(1) and 4B(3) of the Crimes Act 1914 ).  This is consistent with other offence provisions in Part 3 of the NHS Act and is set at a level needed to maintain general deterrence as a safeguard against risks to public health and safety. 

 

Subdivision D - Further provisions relating to confirmatory testing

 

Section 38F - Initial tester must report transfer of biological agent or sample for confirmatory testing

 

Section 38F requires the initial tester to report the transfer of the biological agent or sample for confirmatory testing whether that testing is done at another laboratory operated by the initial tester or by another entity.  The report must:

·          state that the initial tester has transferred the biological agent or sample;

·          identify the other laboratory (either operated by the initial tester or by another entity);

·          contain the information required in a form approved by the Secretary; and

·          be provided to the Secretary within two business days after the transfer or such longer period that the Secretary allows. 

 

Section 38G - Offence failure by initial tester to report transfer

 

Section 38G establishes an offence for failure to comply with new section 38F which sets out the requirement for an initial tester to report the transfer of the biological agent or a sample of it for confirmatory testing. 

 

A maximum penalty of 500 penalty units may be imposed.  This equates to $55,000 for an individual and $275,000 for a body corporate (see subsections 4AA(1) and 4B(3) of the Crimes Act 1914 ).  This is consistent with other offence provisions in Part 3 of the NHS Act and is set at a level needed to maintain general deterrence as a safeguard against risks to public health and safety. 

 

Section 4K of the Crimes Act 1914 does not apply to the offence in section 38G.  This means that the offence is not committed on a daily or continuing basis.

 

Section 38H - Initial tester must report results of confirmatory testing to Secretary

 

This section requires the initial tester to report the results of the confirmatory testing to the Secretary to the Department of Health and Ageing.  The report must:

·          be in a form approved by the Secretary;

·          state whether the biological agent is or is not an SSBA;

·          include other information required by the approved form; and 

·          be given to the Secretary within two business days (or such longer period as the Secretary allows) after the initial tester becomes aware of whether the biological agent is or is not an SSBA.

 

The section also includes (at subsection 38H(3)) an exception to this requirement.  The initial tester need not report to the Secretary if:

·          the initial tester is a registered entity.  A registered entity is defined in subsection 3(1) of the NHS Act and means an entity that is registered under section 44 or 47 on the basis of reports that are required to be provided to the Secretary.  The exemption for registered entities is consistent with the reporting obligations imposed on a registered entity in section 48 of the NHS Act whereby reports are not required for the handling of more quantities of the same SSBA for which the entity is already registered; or

·          the confirmatory testing that was done by the initial tester in the initial testing laboratory indicates that the biological agent is not an SSBA.    

 

Notes at the end of the section inform readers:

·          of other reporting obligations.  For example, section 48 requires the initial tester to report to the Secretary (subject to new section 38K) if the initial tester is a registered entity, and confirmatory testing indicates that the biological agent is an SSBA that is not included in the National Register; and

·          that in a prosecution of an offence against new section 38J, the defendant bears an evidential burden if they wish to rely on the exception and not make a report (because they are a registered entity or because the biological agent is not an SSBA).  Given that inappropriate handling of an SSBA has potential to cause damage to public health and safety and the environment, and that an initial tester would be in an exclusive position to know if an agent was an SSBA, an initial tester (as defendant) should bear the evidential burden of relying on the exemptions provided in subsection 38H(3) .

 

Section 38J - Offence failure to report results of confirmatory testing to Secretary

 

Section 38J sets provides that an entity which is required to report the results of the confirmatory testing under section 38J commits an offence if the entity fails to report to the Secretary as required under that section. 

 

A maximum penalty of 500 penalty units may be imposed.  This equates to $55,000 for an individual and $275,000 for a body corporate (see subsections 4AA(1) and 4B(3) of the Crimes Act 1914 ).  This is consistent with other offence provisions in Part 3 of the NHS Act and is set at a level needed to maintain general deterrence as a safeguard against risks to public health and safety. 

 

Section 4K of the Crimes Act 1914 does not apply to the offence.  This means that the offence is not committed on a daily or continuing basis.

 

Section 38K - Reporting if biological agent disposed of after confirmatory testing shows it is a security-sensitive biological agent

 

In circumstances where a biological agent is disposed of after confirmation that it is an SSBA, section 38K provides for disposal reporting requirements and exemptions from other reporting requirements in sections 42 or 48.  This section applies if:

·          it is determined from the confirmatory testing that the biological agent is an SSBA; and

·          within two business days, or such longer period as the Secretary allows, after making or becoming aware of the determination, an entity that carried out the confirmatory testing or is the initial tester, disposes of its entire holdings of the biological agent; and

·          the disposal is carried out in accordance with the SSBA Standards relating to the disposal of a biological agent that was previously suspected, on the basis of testing in a laboratory, of being an SSBA; and

·          before the entity carried out the disposal, the biological agent was not included on the National Register in relation to the entity.



In these circumstances, the entity must give the Secretary a report that:

·          states that the entity has disposed of its entire holdings of the biological agent in accordance with the relevant SSBA Standards; and

·          is in a form approved by the Secretary; and

·          includes the information required by the approved form.

 

The report must be given to the Secretary within two business days after completing the disposal (or such longer period as the Secretary allows).

 

If the entity gives the Secretary a report in accordance with this section, then section 42 and paragraph 48(1)(a) do not apply, and are taken never to have applied, in relation to the handling of the biological agent by the entity.  These provisions relate to reporting requirements for entities that handle SSBA and reportable events that must also be reported by a registered entity.

 

Section 38L - Offence failure to report disposal

 

Section 38L establishes an offence for an entity’s failure to report disposal in accordance with new section 38K.

 

A maximum penalty of 500 penalty units may be imposed.  This equates to $55,000 for an individual and $275,000 for a body corporate (see subsections 4AA(1) and 4B(3) of the Crimes Act 1914 ).  This is consistent with other offence provisions in Part 3 of the NHS Act and is set at a level needed to maintain general deterrence as a safeguard against risks to public health and safety. 

 

Section 4K of the Crimes Act 1914 does not apply to the offence.  This means that the offence is not committed on a daily or continuing basis.

 

Subdivision E - Further provisions relating to destruction

 

Section 38M - Initial tester must report destruction of biological agent

 

This section provides that if the biological agent is destroyed and confirmatory testing has not been completed when the destruction occurs, the initial tester must give to the Secretary a report about the destruction that is in a form approved by the Secretary and includes the information required in the form.  The report must be provided within two business days after the destruction, or such longer period as the Secretary allows. 

 

The exception to this (where a report is not required) is if the initial tester’s suspicion is that the agent is an SSBA for which the entity is already registered to handle.

 

A note informs readers that in a prosecution of an offence against new section 38N, the defendant bears the evidential burden if they wish to rely on this exception (in accordance with subsection 13.3(3) of the Criminal Code ).  Given that inappropriate handling of an SSBA has potential to cause extreme damage to public health and safety and the environment, and an initial tester would be in an exclusive position to know if an agent was an SSBA, an initial tester (as defendant) should bear an evidential burden if they wish to rely on the exception in section 38M .

 

Section 38N - Offence failure to report destruction

 

This section establishes an offence for an entity’s failure to report the destruction of the biological agent required by section 38N. 

 

A maximum penalty of 500 penalty units may be imposed.  This equates to $55,000 for an individual and $275,000 for a body corporate (see subsections 4AA(1) and 4B(3) of the Crimes Act 1914 ).  This is consistent with other offence provisions in Part 3 of the NHS Act and is set at a level needed to maintain general deterrence as a safeguard against risks to public health and safety. 

 

Section 4K of the Crimes Act 1914 does not apply to the offence.  This means that the offence is not committed on a daily or continuing basis.

 

Section 38P - Direction to dispose of biological agent for failure to comply with section 38B

 

Section 38P enables the Secretary to direct an initial tester to dispose of its entire holdings of the suspected SSBA if the initial tester has contravened new section 38B by failing to carry out confirmatory testing or destroying the suspected SSBA. 

 

The Secretary may give the initial tester a written direction, requiring the initial tester, within the period specified in the direction or such longer period as the Secretary allows, to destroy its entire holdings of the biological agent in accordance with the SSBA Standards.  The period specified in the Secretary’s direction must be reasonable having regard to the circumstances.

 

Section 38Q - Offence failure to dispose of biological agent as directed

 

This section establishes an offence that applies to an entity that has been directed to dispose of the biological agent (under new section 38P) and does not comply with the direction within the period allowed. 

 

A maximum penalty of 500 penalty units may be imposed.  This equates to $55,000 for an individual and $275,000 for a body corporate (see subsections 4AA(1) and 4B(3) of the Crimes Act 1914 ).  This is consistent with other offence provisions in Part 3 of the NHS Act and is set at a level needed to maintain general deterrence as a safeguard against risks to public health and safety. 

 

Section 4K of the Crimes Act 1914 does not apply to the offence.  This means that the offence is not committed on a daily or continuing basis.

Items 13 and 14

These items make consequential changes by adding new notes to sections 42 and 48.

 

The new note:

·          in section 42 informs readers that the effect of the application of new section 38K is to treat section 42 as never having applied in certain circumstances.  Section 42 requires an entity that handles SSBAs to report to the Secretary within two business days or a specified longer period, after it starts handling an SSBA.  Under new section 38K if an entity gives the Secretary a report about the disposal of a confirmed SSBA in accordance with that section, then the reporting obligations in section 42 do not apply; and

·          in section 48 reminds readers that if, under new section 38K, an entity gives the Secretary a report about the disposal of a confirmed SSBA, then the reporting obligations in paragraph 48(1)(a) do not apply. 

 

Item 15

This item inserts provisions to deal with the suspension of the reporting requirements relating to suspected SSBAs to deal with threats posed by SSBA-related disease outbreaks in emergency disease situations (in Part 1 of this Bill).  Because the new provisions relating to emergency disease situations will commence before the suspected SSBA provisions, the amendments to the emergency disease situations described in this item will be made when provisions dealing with the regulation of suspected SSBAs take effect. 

 

This item repeals the heading inserted by item 1 of this Bill (that inserted the heading ‘Division 5A - Suspension of Division 5 to deal with threats’), and substitutes a new heading:

‘Division 5A - Suspension of Divisions 4A and 5 to deal with threats ’.

 

Items 16 to 18

Consistent with new subsection 60A(1), item 16 inserts a new subsection 60(1A) which enables the Minister, by legislative instrument, to specify that certain regulatory obligations in relation to biological agents that are or have been suspected on the basis of testing in a laboratory of being SSBAs, do not apply for a specified period.  The subsection enables the Minister to specify that all or specified provisions of new Division 4A and new section 38D (so far as it relates to the SSBA Standards) do not apply and that any specified conditions must be complied with.

 

The extreme nature of a threat posed by an SSBA-related disease outbreak warrants this delegation of legislative power to ensure that an appropriate and immediate response can be made to the challenge of safeguarding public health and safety in an emergency disease situation. 

 

A note in item 16 informs readers of a drafting change: that the heading to new section 60A is altered to reflect the inclusion of new Division  4A. 

 

Items 17 and 18 make minor consequential amendments to new sections 60A and 60B so that the new provisions relating to emergency situations (as set out in Part 1) will also apply to biological agents suspected of being SSBA from the time that the new provisions relating to suspected SSBA take effect.  This will be within 6 months of Royal Assent, on a date to be set by Proclamation.

 

Items 19, 20 and 21

Section 61 enables the Secretary to arrange for SSBA to be disposed of if the entity fails to comply with a direction to dispose of the SSBA or if the entity is convicted of an offence for failing to report handling of an SSBA under section 43.    

 

The amendments made by items 19 to 21 extend the power of the Secretary to arrange disposal in relation to suspected SSBAs.  The Secretary can arrange for disposal where:

·          there is failure to comply with a direction given under new subsection 38P(2) (to dispose of an entity’s entire holdings of the biological agent if the initial tester contravenes new section 38B);  or

·          an offence has been committed under new subsection 38Q(1).

 

Item 22

Section 65 deals with the powers of an inspector to monitor compliance.  That section allows inspectors to enter premises and exercise monitoring powers to find out whether the legislation is being complied with and also to verify that information provided to the Secretary under specified provisions is accurate and up-to-date.  This item makes a consequential change to this section to ensure that it also allows inspectors to verify information provided to the Secretary in relation to suspected SSBAs in accordance with new sections 38F, 38H, 38K and 38M.

 

Item 23

This item makes a consequential change to section 66 (monitoring powers) so that the provision applies not only to confirmed or known SSBAs but also to suspected SSBAs.

 

Item 24  

Division 8 of the NHS Act deals with merits review of the Secretary’s decisions.  Section 80 sets out the meaning of a reviewable decision .  This item makes a consequential amendment to section 80 so that it applies to both known SSBA and suspected SSBA.  The item includes a new definition of reviewable decision at paragraph (aa) to include the Secretary’s decision made under new subsection 38P(2) to give a direction to an entity requiring the entity to dispose of a biological agent suspected on the basis of testing in a laboratory of being an SSBA.   

 

Item 25 

Division 9 deals with the confidentiality of information and section 84 provides a definition of protected information for the purposes of Part 3.  The amendment made by this item extends the definition of protected information to the new Division 4A that sets out requirements relating to suspected SSBAs.

 

Items 26 and 27

Subsection 85(1) enables the Secretary to give a report to certain agencies in order for them to assess the security risks posed by SSBAs and to take action in relation to those risks.  Subsection 85(3) provides that for the purposes of subsection (1) a security risk includes the possibility that a release of an SSBA may be a public health risk or may cause damage to the environment. 

 

The amendments made by these items make consequential changes to section 85 to enable the Secretary to provide reports to those agencies about suspected SSBAs, in addition to confirmed or known SSBAs. 



PART 3 - INSPECTORS’ POWERS

 

Outline

Currently under the NHS Act an inspector may enter premises only with the consent of the occupier.  There are no provisions for an inspector to apply for a search and seizure warrant.  If such a warrant is required, inspectors would need to refer the matter to relevant authorities for investigation.  This impedes timely investigations in circumstances where the inspector has reasonable grounds for suspecting that there is evidential material of the commission of an offence. 

 

This Part introduces new provisions enabling inspectors to obtain and exercise offence-related warrants.  The new measure also provides for dealing with seized material and reasonable compensation for disposal of things or damage to electronic equipment.

 

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.

 

The extreme nature of this threat supports the need for the coercive and extensive powers that are proposed to be provided to inspectors to facilitate their inspections under the SSBA regulatory scheme.  In particular, the use of necessary and reasonable force in executing an offence-related warrant is fundamental to the security controls of the SSBA regulatory scheme.

 

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. 

 

Items 28, 29 and 30

These items insert new definitions at subsection 3(1) relating to the new inspector’s powers.  New definitions are provided for:

·          offence-related powers - this has the meaning given by new section 70A;

·          offence-related warrant - this means a warrant issued by a magistrate under new section 70M or a warrant signed by a magistrate under new section 70N; and

·          person assisting an inspector - this has the meaning given by new section 70B.   

 

Item 31

This item repeals section 68 which deals with compensation for damage to electronic equipment because new section 79A provides for that matter.

 

Item 32

This item repeals section 70 and inserts new provisions (sections 70A - 70P) that comprehensively provide for an inspector’s entry to premises by consent or under an offence-related warrant. 

 

Section 70 - Inspector may enter premises by consent or under a warrant

 

Proposed new section 70 provides that if an inspector has reasonable grounds for suspecting that there may be evidential material on any premises, the inspector may enter the premises and exercise the offence-related powers set out in new section 70A.  However, an inspector is not authorised to enter the premises unless the occupier of the premises has consented to the entry and the inspector has shown their identity card if required by the occupier or the entry is made under an offence-related warrant. 

 

Section 70A - Offence-related powers of inspectors

 

Section 70A describes an inspector’s powers if entry is made with the occupier’s consent or under an offence-related warrant.

 

If entry to the premises is with the occupier’s consent, an inspector is able to search the premises and any thing on the premises for the evidential material the inspector has reasonable grounds for suspecting may be on the premises.

 

If entry to the premises is under an offence-related warrant, an inspector is able to search the premises and any thing on the premises for the kind of evidential material specified in the warrant and also seize any evidential material the inspector finds.

 

Other offence-related powers that an inspector may exercise in relation to premises are:

·          the power to inspect, examine, take measurements of, conduct tests on or take samples of evidential material;

·          the power to make any still or moving image or any recording of the premises or evidential material; and

·          the power to take onto the premises such equipment and materials as the inspector requires for the purpose of exercising powers in relation to the premises.

 

In relation to electronic equipment, the section provides that:

·          inspectors may operate electronic equipment on the premises to see whether the equipment (or a disk, tape or other storage device that is on the premises and can be used with the equipment or is associated with it) contains evidential material;

·          if evidential material is found, the inspector may also:

-           seize the equipment and the disk, tape or other storage device referred (if entry to the premises was under an offence-related warrant);

-           operate electronic equipment on the premises to: put the evidential material in documentary form and remove the documents from the premises; or to transfer the evidential material to a disk, tape or other storage device that is brought to the premises or is on the premises and the use of which for that purpose has been agreed in writing by the occupier of the premises and remove the disk, tape or other storage device from the premises.

·          inspectors may only operate electronic equipment (as described above) if he or she believes on reasonable grounds that the operation of the equipment can be carried out without damage to the equipment;

·          an inspector may seize equipment or a disk, tape or other storage device if:

-           it is not practicable to put the evidential material in documentary form or to transfer the evidential material; or

-           if possession of the equipment or the disk, tape or other storage device by the occupier could constitute an offence against a law of the Commonwealth.

 

Section 70A also provides an inspector with the power to seize other evidential material in the course of searching for the kind of evidential material specified in the warrant.  The conditions for exercising that power are:

·          an inspector has entered the premises under an offence-related warrant; and

·          in the course of searching for the kind of evidential material specified in the warrant, the inspector finds a thing that the inspector believes on reasonable grounds to be other evidential material; and

·          the inspector believes on reasonable grounds that it is necessary to seize the thing in order to prevent its concealment, loss or destruction;

Section 70B - Persons assisting inspectors

 

This section provides that an inspector may, in entering premises under new section 70 and in exercising offence-related powers in relation to the premises, be assisted by other persons if that assistance is necessary and reasonable.  A person assisting the inspector may enter the premises and exercise offence-related powers in relation to the premises, but only in accordance with a direction given to the person by the inspector.

 

A power exercised by a person assisting the inspector is taken for all purposes to have been exercised by the inspector.

 

The section clarifies that if a direction is given in writing to a person assisting the inspector, the direction is not a legislative instrument.  This clarifies for readers that such a direction is not a legislative instrument within the meaning of section 5 of the Legislative Instruments Act 2003 .

 

Section 70C - Use of force in executing a warrant

 

Section 70C provides for an inspector, and person assisting the inspector, to use such force against persons and things as is necessary and reasonable in the circumstances in executing an offence-related warrant.

 

Section 70D - Inspector may ask questions and seek production of documents

 

Section 70D deals with an inspector’s requests to answer questions and to produce documents if entry is with the occupier’s consent or under an offence-related warrant.  In both situations, the inspector may ask the occupier to:

·          answer any questions relating to the reasons for the inspector entering the premises that are put by the inspector; and

·          produce any document relating to the reasons for the inspector entering the premises that is requested by the inspector.

 

If an inspector is authorised to enter premises by an offence-related warrant, the inspector may also require any person on the premises to answer certain questions and produce certain documents, as described above.  A person commits an offence if the person is subject to a requirement to answer questions or produce documents and the person fails to comply with the requirement.  The penalty for contravention is 30 penalty units which equates to $3,300 (see subsection 4AA(1) of the Crimes Act 1914 ).  This is consistent with the penalty for the offence relating to monitoring warrants in subsection 66(2). 

 

Section 70E - Inspector to be in possession of warrant

 

Section 70E requires that if an offence-related warrant is being executed in relation to premises, an inspector executing the warrant must be in possession of the warrant issued by the magistrate under new section 70M, or a copy thereof, or the form of warrant completed under new subsection 70N(6), or a copy thereof.

 

Section 70F - Occupier to provide inspector with facilities and assistance

 

Section 70F requires the occupier of premises to which an offence-related warrant relates, or another person who apparently represents the occupier, to provide the inspector executing the warrant (and any person assisting the inspector) with all reasonable facilities and assistance for the effective exercise of their powers.  A person commits an offence if they fail to do so.  The penalty for contravention of this requirement is 30 penalty units which equates to $3,300 (see subsection 4AA(1) of the Crimes Act 1914 ).  This is consistent with the penalty for the offence relating to monitoring warrants in subsection 66(2). 

 

Section 70G - Copies of seized things to be provided

 

Section 70G requires an inspector, if requested to do so, to provide copies of seized material that can be readily copied to the occupier of the premises, or another person who apparently represents the occupier and who is present when the warrant is executed.  The copies must be provided as soon as practicable after the seizure.

 

This requirement does not apply if possession of the document, film, computer file, thing or information by the occupier or other person could constitute an offence against a law of the Commonwealth.

 

Section 70H - Receipts for things seized

 

Section 70H requires an inspector to provide a receipt for one or more things that are seized under this Subdivision.  If two or more things are seized, they may be covered by the one receipt.

 

Section 70J - Return of seized things

 

Section 70J deals with the Secretary’s return of material seized under this Subdivision.  The section requires the Secretary to take reasonable steps to return the material to the person from whom it was seized (or to the owner if that person is not entitled to possess it) if:

·          the reason for its seizure no longer exists; or

·          it is decided that it is not to be used in evidence; or

·          60 days has elapsed since the seizure. 

 

The exceptions to this are:

·          if seized material is forfeited or forfeitable to the Commonwealth or is the subject of a dispute as to ownership; or

·          if proceedings in respect of which the thing may afford evidence were instituted before the end of the 60 days and have not been completed (including an appeal to a court in relation to those proceedings); or

·          the thing may continue to be retained because of an order under new section 70K; or

·          the Commonwealth, the Secretary or an inspector is otherwise authorised (by a law, or an order of a court, of the Commonwealth or of a State or Territory) to retain, destroy, dispose of or otherwise deal with the thing; or

·          to return the thing could cause an imminent risk of death, serious illness, serious injury or serious damage to the environment.

 

Section 70K - Magistrate may permit a thing to be retained

 

Section 70 provides for an inspector to apply to a magistrate for an order permitting the retention of the thing for a further period. 

 

Before making the application, the inspector must take reasonable steps to discover who has an interest in the retention of the thing and, if it is practicable to do so, notify such person or persons of the inspector’s proposed application to the magistrate.

 

An inspector may apply for such an order if, before the end of 60 days after the seizure (or the end before the end of a period previously specified in a magistrate’s order), proceedings in respect of which the thing may afford evidence have not commenced.

         

If the magistrate is satisfied that it is necessary for the thing to continue to be retained, the magistrate may order that the thing continue to be retained for a specified period which must not exceed three years.  The magistrate has to be satisfied that it is necessary to retain the thing:

·          for the purposes of an investigation as to whether an offence against this Act, or an offence against the Crimes Act 1914 or the Criminal Code that relates to this Act, has been committed; or

·          to enable evidence of such an offence to be secured for the purposes of a prosecution.

         

Section 70L - Disposal of things

 

Section 70L provides for the Commonwealth to pay a reasonable amount of compensation in circumstances in which a disposal of seized material results in an acquisition of property from a person otherwise than on just terms. 

 

Section 70M - Issue of offence-related warrants

 

Section 70M deals with the application, issue and content of an offence-related warrant (as defined in subsection 3(1)). 

 

An inspector may apply for a warrant in relation to premises and the magistrate may issue such a warrant if the magistrate is satisfied, by information on oath or affirmation, that there are reasonable grounds for suspecting that there is, or there may be within the next 72 hours, evidential material on the premises.

 

The magistrate must not issue the warrant unless the inspector or some other person has given to the magistrate, either orally or by affidavit, such further information (if any) as the magistrate requires concerning the grounds on which the issue of the warrant is being sought.

 

The warrant must:

·          describe the premises to which the warrant relates;

·          state that the warrant is issued under this Subdivision and specify the kind of evidential material that is to be searched for under the warrant; and

·          name one or more inspectors and authorise the named inspector or inspectors to enter the premises and to exercise the powers set out in new sections 70, 70A, 70B, 70C and 70D in relation to the premises; and

·          state whether the entry is authorised to be made at any time of the day or during specified hours of the day; and

·          specify the day (not more than one week after the issue of the warrant) on which the warrant ceases to be in force.

 

Section 70N - Offence-related warrants by telephone, fax etc.

 

To address the urgent circumstances of an investigation, section 70N enables application to a magistrate by an inspector for an offence-related warrant by telephone, fax or other electronic means.  Such an application may be made if the inspector believes on reasonable grounds that the delay that would occur if an application were made in person would frustrate the effective execution of the warrant.

         

Before applying for the warrant, the inspector must prepare information that sets out why the inspector believes that there are reasonable grounds for suspecting that there is, or there may be within the next 72 hours, evidential material on the premises.  If it is necessary to do so, the inspector may apply for the warrant before the information is sworn or affirmed

 

The magistrate may issue the warrant if the magistrate is satisfied, after considering the information and after receiving any further information, that there are reasonable grounds for issuing the warrant.  The warrant is the same as the type the magistrate would issue under section new 70M if the application had been made under that section.

 

If the magistrate completes and signs the warrant, the magistrate must inform the inspector by phone, fax or other electronic means, of the terms of the warrant and the day on which and the time at which the warrant was signed.

 

Following this process, various steps must be taken to authenticate the issue of the completed form of the warrant.  These steps are described in subsections 70N(6) - (10).  

Section 70P - Offence relating to warrants by telephone, fax etc.

 

Section 70P describes offences, with a maximum penalty of imprisonment for two years, relating to an inspector’s application for an offence-related warrant by telephone, fax, etc.  An inspector must not:

·          state in a document that purports to be a form of warrant under new section 70N the name of a magistrate unless that magistrate signed the warrant;

·          state on a form of warrant under that section a matter that, to the inspector’s knowledge, departs in a material particular from the terms of the warrant signed by the magistrate under that section;

·          purport to execute, or present to another person, a document that purports to be a form of warrant under that section that the inspector knows has not been approved by a magistrate or departs in a material particular from the terms of a warrant signed by a magistrate; or

·          give to a magistrate a form of warrant under that section that is not the form of warrant that the inspector purported to execute.

 

Item 33

This item adds new subsection 72(3) which clarifies that new section 70B, which enables inspectors to be assisted by other persons, is not limited by section 72 which enables inspectors to be assisted by a person with scientific or technical knowledge or expertise.

 

Item 34

This item repeals sections 75 and 76 that deal with how an inspector obtains consent from a person for the purposes of an inspector’s searches under monitoring or offence-related warrants.  The new sections 75 and 76 deal more comprehensively with the requirements for obtaining consent and providing details of the warrants to ensure that entry by an inspector is lawful.

 

Item 35

This item inserts a reference to offence-related warrant at subsection 77(1).  Subsection 77(1) requires certain procedures to be observed before an inspector enters premises under warrants (‘before entry requirements’).  An inspector is required to announce that they are authorised to enter the premises and to give any person at the premises an opportunity to allow entry.  The amendment made by this item extends these requirements to an offence-related warrant.

 

Item 36

This item inserts a new requirement at subsection 77(1) to the before entry requirements.  Paragraph 77(1)(aa) requires an inspector to show his or her identity card to the occupier of the premises, or to another person who apparently represents the occupier, if the occupier or other person is present at the premises.

 

Item 37

Subsection 77(2) provides that in certain circumstances an inspector is not required to comply with the before entry requirements at subsection 77(1).  This item adds new subsection 77(3) to require that if an inspector does not comply with the before entry requirements because of subsection (2), and the occupier of the premises, or another person who apparently represents the occupier, is present at the premises, the inspector must, as soon as practicable after entering the premises, show his or her identity card to the occupier or other person.

 

Item 38

This item inserts a reference to ‘offence-related warrant’ at subsection 78(1).  The amendment extends the entitlement for the occupier, or their representative, to be present at searches made under a monitoring warrant to an offence-related warrant.

 



Item 39

This item adds new section 79A which deals with compensation for damage to electronic equipment.  The new provision extends compensation for damage to the exercise of an offence-related warrant and retains existing compensation arrangements. 

 

PART 4 - REPORTING

 

Division 1 - Reporting to police

 

Outline

This measure requires registered entities to report certain existing reportable events to a police force in the State or Territory.  Reporting to a State/Territory police force is additional to the requirement in subsection 48(3) for registered entities to give a report about the reportable event to the Secretary. 

 

The reportable events that should be reported to State/Territory police forces will enhance security in dealing with certain events.  Those reportable events include the loss or theft of an SSBA for which the entity has been registered and other reportable events that will be prescribed in the regulations. 

 

Items 40, 41 and 42

These items make consequential amendments to sections 47 and 48 to refer to the new additional reporting requirement that is provided under new section 48A.

 

Item 43

This item inserts new sections 48A and 48B which deal with reporting certain reportable events to a State or Territory police force.

 

Section 48A - Registered entity must report certain reportable events to police

 

The new requirements to report events to police apply if a reportable event occurs (in relation to a registered entity or facility) in a State/Territory and the event is one described in paragraph 48(1)(f) or prescribed in the regulations. 

 

The regulations already set out the reportable events that must be reported to the Secretary of the Department of Health and Ageing.  These events include unauthorised access to SSBA, unauthorised access to sensitive information, unsuccessful transfer of SSBA and unauthorised handling. 

 

In developing those regulations, consultations with State/Territory law enforcement agencies highlighted the need to also report these events to police to enhance security in dealing with the event.  Given that the regulations already describe circumstances in which events must be reported to the Secretary, it is consistent that the regulations also provide for those events that must be reported to the police and the period for reporting to police. 

 

Section 48A requires that the report to the police:

·          be in a form approved by the Secretary and include information required by the approved form; and

·          be given within the period prescribed by the regulations.  The regulations may prescribe different periods in relation to different reportable events and a period in relation to a reportable event that ends before or after the event ends.  Further consultations will be undertaken to develop these regulations.

 

Section 48B - Offence failure to report reportable event to police

 

Section 48B provides for a criminal offence if a registered entity fails to report a reportable event to a State or Territory police force as required by new section 48A.  A maximum penalty of 500 penalty units ($55,000) for an individual and 2,500 penalty units ($275,000) for a body corporate may be imposed by a court (see subsections 4B(3) and 4AA(1) of the Crimes Act 1914 ).  This penalty is consistent with other offence provisions in Part 3 of the NHS Act and is set at a level needed to maintain general deterrence as a safeguard against risks to public health and safety.   

 

It should also be noted that section 4K of the Crimes Act 1914 does not apply to an offence of this type.  This means that the offence is not committed on a daily or continuing basis.

 

Items 44 and 45

Section 53 provides for the Secretary to require that an entity which has failed to provide a report about a reportable event do so within a specified period, failing which the Secretary may direct the entity to dispose of its entire holdings of the SSBA.  These items amend section 53 to enable the Secretary to exercise his or her discretion if an entity fails to report certain reportable events to the police as required by new section 48A. 

 

Items 46 to 50

These items amend section 55 which clarifies the application of reporting requirements of individuals employed by an entity.  The items amend section 55 to include the reporting requirement to police described in new section 48A.  There is no substantive change to the way reporting requirements (of individuals employed by an entity) apply to the new reporting to police.

Division 2 - Periodic nil reporting

 

Outline

This Division makes amendments to require registered entities to give reports to the Secretary where there have been no reportable events of the kind described in section 48(1) and the regulations. 

 

Currently the regulations provide for entities to report certain reportable events on a regular basis (biannually if handling Tier 1 and annually if handling Tier 2).  Those matters include changes to matters recorded on the National Register such as the entity’s name, location, postal address, telephone, fax, email and ABN. 

 

Requiring regular reports of those matters even if there are no changes will ensure that entities regularly audit their administrative details.  This will ensure that information that is recorded on the National Register is kept up to date. 

 

Item 51

Section 48 describes reportable events in relation to which the registered entity must give reports to the Secretary.  This item amends section 48 to require that a report must also be submitted if there is no occurrence of a reportable event during a period to be prescribed in the regulations.

 

PART 5 - CANCELLATION OF REGISTRATION ON APPLICATION

 

Outline

This Part makes amendments to the NHS Act to enable the Secretary, on application by a registered entity, to cancel an entity’s registration or the registration of one or more of its facilities.  The Secretary may cancel either the registration of the entity or its facility only if he or she is satisfied that the entity or its facility does not handle any SSBA.  This will enable registered entities which do not expect to continue to handle SSBAs to not be subject to the regulatory obligations under the NHS Act.

 

Item 52

This item makes a consequential amendment to section 38 (which deals with variations to the National Register) to cross-reference new section 55A which relates to cancellation of an entity’s registration on application.  The effect of this change is to enable the Secretary to vary the National Register to take account of decisions made under new section 55A to cancel the registration of an entity or its facility.

 

Item 53

This item adds new section 55A at the end of Subdivision B of Division 5 of Part 3.  The new section provides for the Secretary to decide an application by a registered entity to cancel its registration or the registration of its facility. 

 

Section 55A - Cancellation of entity’s registration on application

 

The NHS Act enables the Secretary to register an entity in relation to one or more SSBAs handled by the entity at one or more of its facilities.  The content of the National Register of SSBAs includes the name of the entity, the name and address of each facility where the entity handles SSBAs, and the name of each SSBA handled by the entity at each facility. 

 

This section provides for a registered entity to apply, in a form approved by the Secretary, for cancellation of the entity’s registration:

·          relating to all SSBAs for which the entity has been registered (total cancellation); or

·          as it relates to one or more specified facilities (facility cancellation).  

 

The Secretary may decide:

·          on total cancellation if he or she is satisfied that the entity does not handle any SSBA included on the National Register for that entity; or

·          on facility cancellation only if he or she is satisfied that the entity does not handle, at any of the facilities specified in the application, any SSBA included on the National Register for that entity.

 

If the Secretary decides to cancel the registration, he or she must provide written notification to the entity of the Secretary’s decision, including information (if any) prescribed by the regulations.  Failure by the Secretary to comply with this requirement does not affect the validity of the Secretary’s decision.

 



Item 54

This item makes a consequential amendment to section 80 which provides the meaning of reviewable decision , to include a reference to new section 55A.  The effect of this change is that the Secretary’s decisions relating to cancellation will be subject to the merits review mechanisms provided in Division 8.

 

PART 6 - DEFINITION OF BIOLOGICAL AGENTS

 

Item 55

The definition of biological agents at subsection 3(1) includes bacteria and viruses that can spread rapidly.  This item amends the definition by omitting the words ‘that can spread rapidly’.  The qualification is inappropriate because it limits the range of bacteria and viruses that may be of security concern to Australia.  Under the new definition, more potentially harmful biological agents will be covered.  Such bacteria or viruses may be included on the List of SSBAs that the Minister is required to establish under section 31 of the NHS Act.