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Wednesday, 20 June 2007
Page: 1


Senator ABETZ (Minister for Fisheries, Forestry and Conservation) (9:31 AM) —I table the explanatory memoranda relating to the bills and move:

That the bills be now read a second time.

I seek leave to have the second reading speeches incorporated in Hansard.

Leave granted.

The speeches read as follows—

AUSTRALIAN POSTAL CORPORATION AMENDMENT (QUARANTINE INSPECTION AND OTHER MEASURES) BILL 2007

The Australian Postal Corporation Amendment (Quarantine Inspection and Other Measures) Bill 2007 amends the Australian Postal Corporation Act 1989 to provide for the inspection and examination of postal articles carried by Australia Post for interstate quarantine purposes.

The bill will implement recommendation 13 of the November 2005 report of the House of Representatives Standing Committee on Agriculture, Fisheries and Forestry entitled Taking Control: a national approach to pest animals.

The bill will also make other minor amendments to clarify the operation of certain provisions of the Australian Postal Corporation Act 1989.

The Australian Postal Corporation Act 1989 currently prohibits the opening of postal articles except in specified circumstances. These exceptions include the opening of articles suspected of containing drugs or articles on which customs duty is payable.

Incoming international mail may also be opened in accordance with powers set out in the Quarantine Act 1908. However, opening of postal articles for interstate quarantine purposes is currently not allowed under the Australian Postal Corporation Act.

The inspection regime proposed in the bill provides that certain procedures must be followed by State or Territory quarantine inspection authorities and that specified records be kept. The record keeping requirements will be set out in amendments to the Australian Postal Corporation Regulations 1996, which will be prepared with a view to commencing at the same time the Interstate Quarantine measures commence.

The bill has been developed in consultation with State and Territory governments and Australia Post. There is general consensus about the proposal, including that the reserved services be exempted from inspection under the scheme because of the low risk of standard letters carrying quarantine material and to ensure Australia Post’s ability to meet its regulated performance standards is not adversely affected.

The scheme will allow prescribed State and Territory inspection agencies to identify and examine articles in the course of normal mail processing, and enable them to deal with the article under the applicable State and Territory laws. It is expected that participating Quarantine inspection agencies will bear the costs of inspection, and will assume responsibility for identifying and isolating articles which are believed to contain quarantine material.

The bill also addresses the concern that Australia Post is currently treated differently from other delivery agents, whose articles are potentially already able to be inspected under the applicable State and Territory law. It is expected that once the bill is enacted, Australia Post will no longer be treated differently to other private delivery agents.

At this stage, Western Australia, Tasmania and the Northern Territory have indicated a wish to be prescribed in the regulations, which will enable them to take advantage of the bill’s provisions to inspect postal articles carried by Australia Post for interstate quarantine purposes. The other jurisdictions have taken the view that they consider the biosecurity risks associated with the interstate mail system to be relatively low and that their focus is better directed at the general risk posed by people and personal effects moving across state borders. The bill will enable them to participate in the scheme by the making of further regulations should they later decide to participate.

It is proposed that the interstate quarantine provisions, and other provisions in Schedule 1 to the bill, commence on proclamation, but not later than 6 months after Royal Assent. This will allow sufficient time for those quarantine inspection authorities which intend to implement an interstate quarantine inspection scheme to make appropriate administrative arrangements.

The bill also contains a number of other amendments.

The bill includes amendments to allow compliance agencies such as the Australian Customs Service and the Australian Quarantine Inspection Service a discretion to pass information to Australia Post regarding seized articles. This information will in turn be able to be passed to other postal administrations. This will ensure that Australia Post is not unnecessarily liable to other postal administrations under the Acts of the Universal Postal Union and is better able to respond to queries about missing mail.

The bill also contains a measure which will streamline the disclosure of scam mail to consumer protection agencies. Once the bill is enacted, Australia Post will be able to hold suspected scam mail for inspection by a consumer protection agency. If upon inspection the mail is found to be evidence of a breach of a consumer protection law, the mail will be able to be dealt with by the relevant consumer protection agency in accordance with the laws they administer. If mail is not found to be scam mail, it will be returned to the mail system as soon as possible. These changes will better protect consumers by allowing the earlier interception of scam mail than is currently possible.

The bill also contains minor technical amendments to ensure that the Australian Postal Corporation Act reflects the introduction of the GST and wine tax.

A further measure will provide the Minister with the flexibility to exempt Australia Post from the current requirement to prepare a service improvement plan where the Minister considers the preparation of the plan is unnecessary in the circumstances. These would include circumstances where the failure to meet a performance standard was beyond the control of Australia Post or if Australia Post had already implemented measures to address any drop in performance.

The bill also includes an amendment to allow regulations made under the Act to deal with determining the level of mail delivery service. For example, this would enable a regulation to set out processes to be used by Australia Post for polling communities to determine whether delivery services should be provided ‘to the property’ if regulation in this area became necessary.


THERAPEUTIC GOODS AMENDMENT BILL 2007

I am pleased to introduce the Therapeutic Goods Amendment Bill 2007.

The amendments provided for in this bill are necessary to allow many devices currently marketed in Australia that are essential for patient treatment and for the ongoing provision of health care services to be supplied beyond 4 October this year whilst under reassessment by the Therapeutic Goods Administration (TGA).

The amendments provided for by this bill create certainty for patients, for healthcare providers, and for the medical device industry in Australia.

In 2002, the Government introduced a new regulatory system for medical devices, which allowed a five year transition period, ending on 4 October this year, for previously marketed devices to comply with new legislative requirements.

These requirements are based on principles developed by the Global Harmonisation Taskforce for medical devices, which comprises regulators and industry representatives from Europe, the United States of America, Canada, Japan and Australia.

Under the existing terms of the transition period, sponsors who wish to continue to supply previously “registered” and “listed” therapeutic devices after 4 October 2007 are required to have their products re-entered in the Australian Register of Therapeutic Goods (ARTG) as “included” medical devices following assessment against the new legislative requirements by the TGA by 4 October this year.

The framework introduced by the Government was, and continues to be, at the vanguard of medical device regulation globally. The framework is one that is in line with international best practice and ensures that products newly available to the Australian community comply with current internationally accepted requirements.

However, when the scheme was introduced it was estimated that in excess of 30,000 devices would need to make the transition to the new scheme and, consequently, require reassessment by the Therapeutic Goods Administration (TGA). This has posed significant challenges for both the medical device industry and the TGA to ensure there is continued supply of vital medical devices after October 2007.

A belated influx of applications and the likelihood of further, last minute applications means the TGA may not be able to complete its assessment of all outstanding transition applications in time for the 4 October 2007 deadline.

Many sponsors who have submitted applications to transition their products are now faced with uncertainty about whether they will be able to continue to supply those products after 4 October 2007. Similarly, purchasers and end-users of devices are faced with the uncertainty about continued access to transitioning products.

Disruption to the supply of medical devices due to failure to transition by 4 October this year could have a significant impact on consumer access to vital medical devices, the supply of medical devices to health care facilities, the operation of health care facilities, consumer confidence in the health system, as well as the economic viability of Australian medical device companies.

The amendment provided for by this Bill substitutes the existing requirement for medical device sponsors to have their products entered in the ARTG as “included” medical devices by 4 October 2007 with a requirement to lodge an application with the intention of transitioning their products to the new scheme by 4 October 2007.

Under these amendments sponsors and end users of medical devices will have certainty of continued supply/access because it will depend solely on the sponsor submitting an effective and successful application to have their product transitioned by 4 October 2007.

The Government places a high priority on the availability of and access to important treatments by Australians and the presence of a strong, vibrant medical devices industry in its therapeutics policy planning.

This new amendment is an important part of that planning, for it allows for continued access to important treatments by Australian consumers and health care providers, whilst ultimately ensuring that all medical devices available in Australia comply with current, internationally accepted requirements.


The PRESIDENT —In accordance with standing order 111, further consideration of these bills is now adjourned to the first day of the next period of sittings.

Ordered that the bills be listed on the Notice Paper as separate orders of the day.