Maxine McKew (Bennelong, Australian Labor Party, Parliamentary Secretary for Early Childhood Education and Child Care) Share this | Hansard source

I present the explanatory memorandum to the bill and I move:

That this bill be now read a second time.

This bill amends the Therapeutic Goods Act 1989 in a number of ways.

Firstly, it incorporates into the act provisions allowing the stockpiling and supply of medical devices to deal with emergency situations without the requirement for such devices to comply with the act.

Second, it gives effect to a range of amendments which have been in contemplation for a number of years, and which were to have been adopted as part of the proposed Australia New Zealand Therapeutic Products Authority, or ANZTPA.

Turning first to the medical devices amendments, these provisions are based on similar provisions allowing medicines to be stockpiled and supplied in emergency situations which were added to the act in 2002.

It is unfortunate that other amendments made to the act that same year to deal with medical devices did not include an emergency provision from the outset. But be that as it may, the government is now acting to include these provisions so that medical devices can lawfully be stockpiled in case of a future emergency and made available in an actual emergency without having to comply with the act.

In 2002 the then parliamentary secretary, in introducing the bill, explained that the amendments were necessary to strengthen the ability of the Commonwealth to plan for, and respond to, national emergencies in which there is the potential for large numbers of people to require emergency treatment. She gave as examples of such emergencies acts of bioterrorism or the emergence of a new, highly contagious disease in Australia.

Exactly the same rationale applies today.

The act presently operates very effectively to ensure that medical devices supplied in Australia to meet our daily health care needs meet very high standards of manufacture and quality control. In general, it is an offence to supply devices that have not been approved by the Therapeutic Goods Administration (the TGA).

But in an emergency the government may need to be able to supply very large volumes of devices such as face masks or injection kits. It may need to source these volumes from manufacturers who do not regularly supply goods to the Australian market, and who have not sought to have their products approved by the TGA.

The amendments in schedule 1 to this bill allow the minister to exempt devices from the requirements of the act so that they can lawfully be stockpiled and made available in an emergency.

The minister can only make such an exemption if she or he is satisfied that it is in the national interest to do so, and the minister’s powers may only be delegated to the Secretary of the Department of Health and Ageing.

The minister may impose conditions on the exemption, including limiting the people allowed to import, manufacture or supply the devices, and must notify those people of any other conditions on the exemption. Breaching a condition of exemption is a criminal offence.

The bill does not provide for parliamentary scrutiny of the exemption through disallowance. This is because a security consultant engaged by the government last year recommended that the contents of the stockpile should be classified as “confidential” to ensure that would-be bio-terrorists were not able to find out what preparations Australia had made for dealing with a possible bio-terrorist act.

For this reason the bill also amends the act so that similar exemptions applying to medicines are not to be subject to disallowance.

Turning to the deferred ANZTPA amendments, the bill deals with the “fit and proper person” test, default standards for medicines, information disclosure, and the use of restricted representations in advertising. It also makes technical amendments to all offence provisions to bring them into line with the latest policy on how these should be expressed.

The act currently requires the secretary, in deciding whether to grant or revoke a manufacturing licence or a conformity assessment certificate for a medical device, to have regard to whether the applicant, a person taking part in managing the applicant’s affairs, or a person “likely to have effective control over the applicant”, is a fit and proper person.

The test in deciding such a person is at once subjective—in that there is no limit on the matters the secretary may consider, and there is no guidance on who is a person “likely to have effective control”—and unduly harsh in that the secretary must have regard to any conviction against any law of the Commonwealth or a state or territory, no matter what the crime or when it took place.

Not only has the test been criticised by industry for these reasons, but it is also administratively problematic.

The amendments in schedule 3 of the bill replace this test with a much narrower test, requiring the secretary to have regard to breaches of the act or offences against it, together with offences involving fraud or dishonesty over the previous 10 years.

The amendments also replace the undefined concept of “effective control” with an objective definition of a “major interest holder”, defined as a one-fifth shareholder of a body corporate.

When the act was introduced it provided that unless the minister determined standards for therapeutic goods, they had to comply with the requirements of the British Pharmacopoeia. The British Pharmacopoeia thus effectively served as the default standard for therapeutic goods.

Since the act came into effect many manufacturers based in the United States or Europe have entered the Australian market. As part of the ANZFTA consultation process industry pressed for the inclusion of the US Pharmacopoeia and the European Pharmacopoeia as alternative default standards.

Schedule 4 of the bill contains a series of amendments to include these pharmacopoeias as default standards with the same standing as the British Pharmacopoeia. The amendments also remove references to the veterinary version of the British Pharmacopoei, as the act no longer regulates veterinary medicines, and makes a number of consequential amendments to remove other references to the regulation of therapeutic goods for use in animals.

The act sets out when the secretary can release information obtained under the act to other regulatory agencies or to the public. These provisions are unduly restrictive as they relate to the public release of information, and they have proved operationally difficult as they relate to providing information to other agencies.

The government has decided to broaden the public access to information under the act.

In particular, the TGA will publish a greater range of information about goods included on the Australian Register of Therapeutic Goods on its website to inform members of the public about the therapeutic goods and devices that are available in Australia, and assist them to make better informed choices and decisions about their use of therapeutic goods.

It will publish the minutes and deliberations of expert advisory committees, as well as a greater range of information considered in, and the reasons for, making particular decisions, including summaries of the evaluation of applications for the entry of prescription medicines on the register.

The amendments in schedule 5 will support this by allowing the minister to determine, by legislative instrument, classes of therapeutic goods information which may be published by the secretary. The amendments also widen the definition of information that may be released to include information held by the TGA, as well as information acquired by the TGA under the act.

Other amendments in the schedule resolve the practical difficulties with the provisions relating to the release of information to other government authorities.

The act currently regulates advertising of therapeutic goods. It includes a regime provided for the pre-approval of some categories of advertisements, together with limits and restrictions on the kinds of representations that may be made in advertisements. For example, advertisements to the public cannot refer to serious illnesses, or make claims that a cure is infallible.

While the limits and restrictions are intended to apply to all advertisements, the current structure of the act implies that they only apply to advertisements that do not require pre-approval.

The amendments in schedule 6 are intended to clarify that the limits and restrictions apply to all advertisements.

Finally, schedule 7 contains a series of purely technical amendments to align all criminal offence provisions in the act with current policy on the expression of such provisions.

The changes made by this bill do not encompass all the reforms the government intends to make to the therapeutic goods regulatory regime.

We intend to introduce further legislation next year to give effect to other changes that were foreshadowed as part of the ANZTPA process, including new frameworks for the regulation of human cellular and tissue-based therapies and homeopathic medicines.

We will also be pursuing changes to the current advertising arrangements. The Productivity Commission has recommended that the government should streamline and clarify the advertising regime for therapeutic goods. At this stage, government intends to carry out informal consultations with industry over the next few months before releasing a formal consultation document for consideration next year.

The amendments in this bill are thus the first instalment in an ongoing program of reform to the act.

Australia has been well served by the TGA in the past, and it is important that the regulatory regime the TGA implements is kept up to date so that the TGA and the industry that it regulates can operate as efficiently as possible, and so that Australian consumers can continue to have timely access to safe and effective therapeutic goods.

I commend this bill to the House.

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