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National Health Security Amendment Bill 2009 [2009] AUSStaCSBRp 61 (9 September 2009)

National Health Security Amendment Bill 2009

Introduction

The Committee dealt with this bill in Alert Digest No. 9 of 2009. The Minister for Health and Ageing responded to the Committee’s comments in a letter dated 18 August 2009. A copy of the letter is attached to this report.

Extract from Alert Digest No. 9 of 2009

Introduced into the House of Representatives on 24 June 2009

Portfolio: Health and Ageing

Background

This bill amends the National Health Security Act 2007 to enhance Australia’s controls for the security of certain biological agents that could be used as weapons. Such an agent is known as a security sensitive biological agent (SSBA).

In particular, the bill:

• enables the Minister for Health and Ageing, following advice from relevant experts, to suspend certain existing regulatory requirements and specify new conditions to ensure that adequate controls are maintained in the event of an SSBA-related disease outbreak;

• establishes new controls relating to the handling of biological agents suspected of being SSBAs;

• 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; and

• makes a number of minor amendments (for example, to include new reporting requirements to local police forces for certain SSBA-related events, to clarify the reporting obligations of registered entities, and to amend the definition of ‘biological agents’).

Insufficient parliamentary scrutiny
Schedule 1, item 1, new sections 60A and 60B

Item 1 of Schedule 1 inserts a new Division 5A into the National Health Security Act to provide for suspension of Division 5 to deal with threats. Proposed new subsections 60A(4), (5) and (6), also to be inserted by item 1 of Schedule 1, provide that legislative instruments created to suspend the usual regulatory obligations for specified periods in emergency situations have effect despite section 12 of the Legislative Instruments Act 2003, and according to their own terms. This would allow instruments to take effect before they are registered on the Federal Register of Legislative Instruments.

The explanatory memorandum explains (at page 7) that this allows instruments to take effect without delay in order to deal with particular emergency disease situations: for example, if there is a need to put measures in place immediately to deal with the extreme threat posed by the spread of an SSBA-related disease outbreak.

Similarly, proposed subsections 60B(4) and (5), also inserted by item 1 of Schedule 1, provide for the issue of a new legislative instrument to vary or revoke an instrument made pursuant to new subsection 60A(1). Such new legislative instruments would also take effect despite section 12 of the Legislative Instruments Act. The explanatory memorandum explains (at page 8) that 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 increased threat posed by a disease outbreak.

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.

Pending the Minister’s advice, the Committee draws Senators’ attention to the provisions, as they may be considered to insufficiently subject the exercise of legislative power to parliamentary scrutiny, in breach of principle 1(a)(v) of the Committee’s terms of reference.

Relevant extract from the response from the Minister

New section 60A of the Bill enables me, as the Minister, to suspend controls imposed by Division 5, Part 3 of the National Health Security Act 2007 (the Act) for a specified period, if I am satisfied that there is a threat involving a security sensitive biological agent (SSBA), to the health or safety of people, the economy or the environment. I am able to do so by legislative instrument. New section 60B enables me, by legislative instrument, to vary or revoke the earlier legislative instrument. The legislative instruments would take effect on the day on which the instrument is made or, if the instrument specifies a later day, on that day.

The Committee notes that, because the new provisions would allow instruments to take effect before they are registered on the Federal Register of Legislative Instruments, the legislative instruments could cover important matters without Parliamentary scrutiny. The Committee seeks advice as to how scrutiny of any emergency arrangements is intended to be provided.

My discretion to make the principal legislative instrument to suspend some or all of the provisions in Division 5 is confined by the circumstances in subsection 60A(2). I am required to be satisfied of two principal matters, that:

1. there is a threat involving the SSBA to the health or safety of people, the economy or the environment; and

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

For example, if the pandemic (H1N1) 2009 had been caused by an SSBA, I may have suspended the requirement for laboratories undertaking testing for the virus from reporting to the National Register on the transfer of samples for a period of three to six months. Such a decision would have taken away an onerous administrative burden which might otherwise have impeded their ability to undertake essential laboratory testing during the pandemic.

In being satisfied of the first matter, I must consider advice from the Commonwealth Chief Medical Officer, the Commonwealth Chief Veterinary Officer and any other person who I believe has scientific or technical knowledge in relation to SSBAs. In being satisfied of the second matter, I must consider advice from the Secretary of the Department of Health and Ageing.

Similarly, in making a legislative instrument to vary or revoke the principal legislative instrument in order to respond to the threat, my discretion to do so is confined by legislative preconditions. Those preconditions include considering further advice from the persons whose advice was considered for the purposes of making the earlier principal instrument.

The Explanatory Memorandum to the Bill explains that the delegation of legislative power is warranted by the extreme nature of a threat posed by an SSBA-related disease outbreak. The legislative instruments will facilitate an appropriate and immediate response to the challenge of safeguarding public health and safety in an emergency disease situation which presents unpredictable scenarios. Because the legislative instrument is a disallowable instrument, it will be subject to Parliamentary tabling and scrutiny processes, albeit that a disallowance would only take effect after the legislative instrument has come into effect.

I am confident that the above process provides the best balance of parliamentary scrutiny in the context of responding appropriately and immediately to an emergency disease situation involving an SSBA.

The Committee thanks the Minister for her comprehensive and helpful response.

Review of decisions
Schedule 1, item 53, new subsection 55A(5)

Proposed new section 55A, to be inserted by item 53 of Schedule 1, provides for total cancellation or facility cancellation in relation to an entity’s registration on the National Register, upon application by the entity for cancellation. Proposed new subsection 55A(4) contains the notification of cancellation procedures that must be followed by the Secretary if he or she decides to cancel the registration; namely, that the entity must be informed in writing of the decision. However, proposed new subsection 55A(5) provides that failure to follow these notification procedures does not affect the validity of the decision.

This has the effect that the obligations of an entity may be altered without notice or without an opportunity for review of the decision. The explanatory memorandum does not provide an explanation for the inclusion of this provision. Therefore, the Committee seeks the Minister’s advice on the reasons for inclusion of new subsection 55A(5) in the bill.

Pending the Minister’s advice, the Committee draws Senators’ attention to the provision, as it may be considered to make rights, liberties or obligations unduly dependent upon non-reviewable decisions, in breach of principle 1(a)(iii) of the Committee’s terms of reference.

Relevant extract from the response from the Minister

New section 55A enables an entity to apply for total cancellation of its registration as an entity, or cancellation of its registration for one or more facilities. The Secretary must decide to cancel the registration in accordance with the application or refuse the application. The Secretary may decide to cancel the registration only if he or she is satisfied that the entity or its facility does not handle any SSBA that is on the National Register.

New section 55A was introduced to enable entities to apply for cancellation of their registration if they no longer handle SSBAs. Cancellation of registration means that the entity is no longer required to comply with the regulatory obligations imposed under the Act. Therefore, if registration is cancelled at the entity’s request, that entity would not be deprived of any rights or liberties.

In contrast, the Secretary’s decision to refuse an application for cancellation is a reviewable decision. This amendment was inserted by item 54 of the Bill. Subsection 81(1) provides that the Secretary must notify the entity as soon as practicable after making a reviewable decision. The Secretary’s decision is then subject to internal review and application to the Administrative Appeals Tribunal, as set out in sections 82 and 83 respectively.

I trust that this clarifies the matters the Committee has raised.

The Committee thanks the Minister for this clarification, which addresses its concerns.