Peter Dutton (Dickson, Liberal Party, Shadow Minister for Health and Ageing) Share this | Link to this | Hansard source

I rise to speak on the National Health Security Amendment Bill 2012. The bill amends the National Health Security Act 2007 with respect to the regulatory arrangements for security sensitive biological agents. Firstly, the bill intends to streamline reporting requirements for entities that handle SSBAs on a temporary basis—that is, less than seven days. Secondly, it provides a secretary with discretion to remove certain handling requirements or impose certain conditions on registered facilities undertaking emergency maintenance. Thirdly, it provides the secretary with powers to impose conditions on an entity's SSBA handling during the time period allowed for an entity to take corrective action to become compliant. Fourthly, it is designed to ensure consistent reporting requirements for confirmatory tests. And, finally, it provides consistency for exempt entities in relation to reporting and handling requirements for SSBAs and suspected SSBAs.

In April 2007 COAG agreed to recommendations from the r eport on the regulation and control of biological agents. Primarily, this involved the implementation of a national legislative regulatory regime to minimise security and public health risks posed by SSBAs. The Department of Health and Ageing states that the aim of the regulatory scheme is to limit the opportunities for acts of bioterrorism or biocrime using harmful biological agents and to provide a legislative framework for managing the security of SSBAs. The scheme was developed to provide appropriate security and management protocols while ensuring access to these agents for those with a legitimate need. The establishment of a two-tiered regulatory arrangement, as recommended by the review, commenced on 31 January 2009 for tier 1 agents and on January 2010 for tier 2.

Tier 1 includes those of the greatest risk to our country , such as E bola virus, SARS, smallpox and the p lague. Tier 2 agents, which are considered of lesser threat, include the likes of t yphoid, cholera and y ellow f ever. The House considered two b ills in the last parliament that amended the a ct with respect to handling and reporting requirements for identified and suspected SSBAs and to provide for background checks for individuals handling and disposing of such agents. The coalition supports appropriate regulatory arrangements in the interests of biosecurity and safeguarding public health.

A recent media report indicates that 1,400 people have been prohibited from working in areas that handle potentially dangerous substances, such as biological agents. According to the report in the Adelaide Advertiser , 334,317 workers have had background checks over the p ast three years through the Aus C heck system. Those banned from access to these materials included 447 people on the basis that they have a conviction for aggravated assault; 462 for violence ; 389 for drug dealing ; 203 for weapons , firearm or explosive offences ; 25 for hostage taking ; 16 for arson or sabotage ; and 42 for armed robbery. Quite clearly it is not in the public interest for these people with these types of histories to have access to any of these items . It reinforces that this regulatory regime is very important to our country .

Schedule 1 amendments in this bill are said to reduce the regulatory burden on nonregistered facilities that only require up to seven working days in which to complete their handling. A non registered entity that presently handles a known SSBA would have to fil l a registration process and then be subject to a lengthy administrative proce ss, involving the instruction to dispose of the respective agent. As the m inister mentioned in her second reading speech , this may affect hospitals or pathology diagnostic facilities.

Item 6 of schedule 1 of the b ill a llows an entity to provide the secretary with a temporary handling report if they intend to dispose of an agent with in seven business days of handling it. They must also provide the secretary with a tem porary handling disposal report at the expiry of the period o f two business days after the disposal. Th is clause allows the s ecretary to impose conditions , in writing , on the handling of an SSBA by an entity that has provided a temporary handling report. It also allows for temporary handling standards, to be provided by a d etermination, and offence provisions for noncompliance. This in turn will exempt an entity from having to meet r equirements for entities that handle secur ity-sensitive biological agents as contained in the main a ct. A registered entity may provide the s ecretary with an emergency report if it needs to undertake unscheduled or unplanned repairs or maintenance. The s ecretary will then be able to issue a written instrument to exempt, modify or omit the requirements specified in division 5 of the act.

The Secretary can impose conditions in the declaration. The EM states this may relate to a direction to the entity not to handle the SSBA for any purpose other to store an SSBA or a requirement to move an SSBA to a registered facility if repairs are not completed within a specified time. An offence may apply to any conditions that are breached. Entities that are deemed noncompliant with relevant standards currently are subject to, as described in the EM, 'a lengthy administrative process' involving the issuing of notices, requirements to take corrective action and, if necessary, the issuing of a notice to dispose.

The bill allows the Secretary to impose conditions on an entity during this period of noncompliance. This may include but is not limited to the physical security of SSBAs, personnel security and information security. The Secretary may give written direction to an entity that does not comply with a condition to dispose of its entire holding of agents. Failure to comply with a direction to dispose of an agent is an offence.

The bill intends to remove an exemption for a registered entity to report a confirmatory testing it conducts as an initial tester. The minister has stated that this should ensure that all registered entities that undertake in-house confirmatory testing are required to provide full reporting of outcomes. I acknowledge the clarification the minister's office has provided by way of departmental advice in relation to this provision. There is also a proposed change so that exempt entities—those that handle agents for transportation purposes—are also exempt from the requirement in relation to suspected SSBAs. This ensures consistency with the act that currently provides exemptions from the requirements for known and listed agents.

The coalition supports the intent of this regulatory regime and acknowledges its importance for biosecurity. The government has stated the scheme itself and this bill have been subject to stakeholder consultation. While this is a very important bill it is obvious that the minister is not here to sum up so I welcome the Parliamentary Secretary. On the basis of that which I have contributed to the House, the coalition does not oppose this bill.

Jill Hall (Shortland, Australian Labor Party) Share this | Link to this | Hansard source

This is extremely important legislation that we have before us tonight. While the National Health Security Amendment Bill 2012 is non-controversial in nature, I feel it is legislation that both sides of this House will support. It introduces greater flexibility to better manage the security risk of sensitive biological agents handled by a number of entities.

The controls currently imposed by the NHS act are quite inadequate to manage the security risks posed at facilities that handle SSBAs on a temporary basis, usually less than seven days before disposal of the SSBA. As the previous speaker mentioned, the minister talked at some length about the situation in hospitals about SSBAs and the need for reporting and disposal. The minister told how changes included in this legislation would improve the safety, efficiency and effectiveness of the way SSBAs are handled. There are lots of facilities that perform emergency maintenance. Following inspection, facilities need to take effective action to fully comply with the standards. There are an increasing number of facilities handling on a temporary basis the post implementation phase of the scheme. The entities may be sent SSBAs to perform specific tests, after which the SSBAs are sent back to a registered facility or destroyed. It is quite important that they be returned or destroyed. It is a matter of being aware of where these SSBAs are at all times.

Inspections have found that some registered facilities which are given time to implement corrective action need to have conditions imposed on them during this time to ensure secure handling of SSBAs. But there has to be some flexibility in performing emergency maintenance.

Inadequate controls mean that there is no management of security risks in these facilities. I know that all members of this parliament are very concerned that security risks are managed at all times. Potentially, there will be increased risks of incidences of non-secured handling. That is the last thing that we would like to see happen. There may be unforeseen consequences of that and there may be effects on public health. For the record, the National Health Security Act has enhanced Australia's obligation to secure certain biological agents. These agents are very harmful, such as anthrax and the foot and mouth virus. SSBAs are security sensitive biological agents. The House notes that the agents that I mentioned are definitely SSBAs. The SSBA regulatory scheme imposes stringent requirements relating to the notification of the type and location of the SSBAs along with standards that must be met by entities handling SSBAs.

The government has worked closely with the entities that handle SSBAs. A number of areas where improvements to the regulatory scheme can be made have been highlighted. The bill will make an impact in two important ways. The proposed amendments provide for streamlined reporting, particularly in relation to where SSBAs are only temporarily handled. I mentioned that a little bit earlier. The second thing that the bill will do is to allow the secretary to better manage potential security risks for entities undertaking emergency facility maintenance, a very important part of this legislation. This is legislation that members on both sides of the House can get behind. It is about ensuring security and public health. I commend the legislation to the House.

Ms Catherine King (Ballarat, Australian Labor Party, Parliamentary Secretary for Health and Ageing) Share this | Link to this | Hansard source

I thank the members for Dickson and Shortland for their contributions to this debate. The National Health Security Amendment Bill 2012 amends the National Health Security Act 2007 to enhance the regulatory scheme for security sensitive biological agents, or SSBAs. The bill enhances the regulatory scheme for SSBAs in two ways. First, the proposed amendments provide a streamlined reporting scheme for entities such as hospital diagnostic facilities that are not registered under the SSBA regulatory scheme and that only need to handle the SSBAs for less than seven consecutive days, which is known as a temporary handling. Specific SSBA standards will apply to the entity during the handling period to ensure that the security of the agent is maintained during that temporary handling.

Second, the amendments will allow the Secretary of the Department of Health and Ageing to better manage potential security risks for entities undertaking emergency maintenance. The amending bill also makes some less significant but equally important amendments to improve the operation of the legislation and provide greater clarity for those working with SSBAs. These relate to imposing conditions to ensure the security of SSBAs is maintained in the facilities that are required to undertake corrective actions following an inspection, clarifying the reporting requirements for biological agents suspected to be SSBAs and ensuring that the application of exemptions for certain entities are consistent between known and suspected SSBAs.

I thank members for their contribution to the debate on this bill and also the departmental officers that we have here with us. I am confident that the bill addresses the issues identified during the operational period of the scheme as well as through stakeholder liaison and will ensure that we continue to deliver on our international commitments and the national imperative to actively improve our capacity to maintain adequate controls on biological agents. I commend the bill to the House.

Question agreed to.

Bill read a second time.

Ordered that this bill be reported to the House without amendment.

Federation Chamber adjourned at 19:10