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Thursday, 19 March 2009
Page: 3232


Mrs ELLIOT (Minister for Ageing) (10:00 AM) —I move:

That this bill be now read a second time.

This bill represents the next step in the government’s move to introduce much needed amendments to the Therapeutic Goods Act 1989.

Many of these amendments were to have been adopted as part of the legislation underpinning the proposed Australia New Zealand Therapeutic Products Authority, or ANZTPA.

The Rudd government has now decided to proceed to implement these amendments as changes to the Australian legislation.

The first change is to introduce into the act a power for the secretary to suspend the registration or listing on the Australian Register of Therapeutic Goods (ARTG) of a medicine if there are concerns about its safety.

Under the act as it currently stands, medical devices can be suspended from the ARTG for up to six months if there are concerns about the safety of the device that could be addressed by corrective action during the period of suspension.

However, such action is not possible with medicines. If serious concerns emerge about the safety of a medicine, the secretary’s only option is to cancel the registration or listing, even if the problems are such that they could be quickly addressed by the manufacturer.

If the registration or listing is cancelled, once the problem has been addressed the sponsor of the medicine must apply to have the medicine re-registered or relisted, and pay the relevant application fees. This is inefficient and costly.

The proposed amendments in schedule 1 of the bill will address this problem.

The second set of changes relate to manufacturing licences. At present a number of licences cover more than one site, and licences do not clearly indicate the steps in manufacture or the range of goods that may be produced under the licence. There is no ability for manufacturers to apply to vary their licences, and no ability to transfer licences from one manufacturer to another.

The proposed amendments in schedule 2 of the bill address these issues by providing that a licence may only cover one site, and must specify the manufacturing processes and the range of goods that it covers.

However, the amendments provide for guidelines to be made allowing the secretary to consider applications covering more than one site. These will allow warehouses or mobile blood collection facilities to be added to a manufacturing licence covering another site.

Schedule 2 also provides for licensees to apply to vary their licences, and for regulations to be made setting out a process for transferring licences.

Thirdly, the act presently contains a number of provisions empowering authorised officers to enter premises and take samples of therapeutic goods regulated under the act.

However, these powers do not allow samples to be taken of related material, such as ingredients intended for use in therapeutic goods, even though the quality of these ingredients is directly relevant to the quality and safety of the finished product.

And these powers are limited to the therapeutic goods that are expected to be on the premises. For example, listing of goods on the ARTG is subject to the condition that the person in relation to whom the goods are listed will allow an authorised officer to enter premises where the person deals in the goods and take samples of those goods. If the officer found other, potentially unapproved, goods on the premises he or she would not be empowered to take samples of them.

The amendments in schedule 3 of the bill address this problem by extending the power to sample any therapeutic goods or anything related to therapeutic goods on the premises.

It also updates the kinds of records authorised persons are allowed to take of premises by replacing references to photographs or sketches, with references to any still or moving image or recording.

The fourth set of amendments put in place a regulatory framework for homoeopathic and anthroposophic medicines.

Under current arrangements the regulations exempt many of these medicines from the need to be listed on the ARTG and from the manufacturing quality requirements of the act.

The expert committee on complementary medicine in the health system recommended, in 2003, that:

… homoeopathic medicines and related remedies making therapeutic claims be regulated to ensure they meet appropriate standards of safety, quality and efficacy.

The government has consulted extensively with homoeopathic and anthroposophic practitioners and suppliers on an appropriate level of regulation for these substances.

The amendments proposed in schedule 4 of the bill put in place a framework allowing standards for these medicines to be set by reference to various pharmacopoeias from July 2011. This delayed commencement date is intended to allow time for this industry sector to prepare to comply with the framework, and to allow time for further consultation on changes to the regulations to give effect to details of the new scheme.

Schedule 5 of the bill relates to the ingredients that are permitted to be included in medicines, and gives a clear legislative backing for current practice.

At present the TGA’s Electronic Listing Facility has built into it a list of permitted ingredients. This list is based on schedules included in the regulations to the act, but includes many substances that were ‘grandfathered’ into the scheme when the act came into effect in 1991 and are not identified in the regulations. The list is published on the TGA website.

Persons wishing to add substances to the list of permitted ingredients currently apply to the TGA and, if the application is accepted, the new ingredient is notified in the Gazette.

As a result there is no single legal source for the ingredients which may be included in medicines.

The proposed amendments will address this by empowering the minister to make a legislative instrument setting out lists of permitted ingredients and prohibited ingredients for different classes of medicines. Persons wishing to list a medicine for domestic use must certify that it contains only permitted ingredients and no prohibited ones, and the secretary, in considering an application to list a medicine for export purposes, must have regard to whether it complies with the list.

A person may apply to include a new ingredient on the permitted ingredients list, and the minister must consider this application.

At present there is no right of review under the act of applications to the TGA to list new ingredients, and the government does not propose to include one for the new provision allowing persons to apply to the minister.

There are two reasons for this. Firstly, the making of the list is a legislative decision—the inclusion of an ingredient on the list will allow general use rather than use only by the applicant. As a legislative decision the list will be subject to parliamentary scrutiny. Second, the minister, in considering the application, will have regard to expert advice from the TGA and its advisory committees.

The sixth group of amendments, made by schedule 6 of the bill, change various references to orders published in the Gazette, and to disallowable instruments, to references to legislative instruments, to clarify that these orders and instruments are legislative instruments and subject to the Legislative Instruments Act 2003.

Schedule 7 contains a range of miscellaneous amendments intended to improve the operation of the act and clarify its operation. I will briefly outline the most significant of these.

Since 2003 the TGA has operated an electronic system to permit sponsors to list low-risk medicines containing pre-approved ingredients on the ARTG without prior scrutiny by the TGA. As part of the listing process sponsors must certify a range of matters relating to the safety and quality of the medicines, and are subject to prosecution under section 21A of the act for providing incorrect certifications. A similar system has recently been introduced for including low-risk medical devices on the ARTG.

The proposed new section 7C regularises this process by providing for computer programs to make decisions that could be made by the secretary, and allowing the secretary to substitute her or his own decision within 60 days of the day on which the decision is made by the computer program in case an error is made.

Under section 30 of the act, sponsors can apply to the secretary to cancel the registration or listing of medicines. However, sometimes sponsors incorrectly apply for cancellation. The proposed new section 30A allows them to apply to the secretary within 90 days to revoke the cancellation.

Section 28 of the act allows the secretary to impose conditions on the registration or listing of individual medicines on the ARTG. However, in practice, the same standard set of conditions are imposed on every product as it is listed or registered, together with a very limited number of product-specific conditions.

To improve transparency and scrutiny the bill will amend section 28 to enable the minister, by legislative instrument, to determine the standard conditions to apply in relation to categories of medicine.

The secretary would retain the power to impose specific conditions on particular goods that are to be included on the ARTG.

Section 28 will also be amended to add to important conditions to apply to all registered or listed medicines:

  • that they are not to be supplied or exported after their expiry date; and
  • that they are not to be advertised for any indication other than that accepted for the listing or registration on the ARTG.

Finally, schedule 7 includes provisions intended to strengthen scrutiny of overseas manufacturing of listed medicines.

Under current provisions, applicants seeking to list a medicine under section 26A of the act and proposing to manufacture the medicines overseas must have obtained prior certification from the secretary that the manufacturing and quality control procedures at the overseas manufacturer are acceptable.

However, after listing has occurred, a sponsor can move the manufacture of a medicine to an overseas manufacturer and simply notify the TGA of the change. The move can be either from a previously approved Australian or overseas manufacturer. As a matter of administrative practice the TGA then reviews the quality of the new overseas manufacturer.

The proposed amendments will underpin this process by imposing a statutory condition on listed medicines that any overseas manufacture must be subject to a certification from the secretary that the manufacturing and quality control procedures are acceptable, and establishing a procedure for a person to apply to the secretary for such a certification.

The government intends to make further changes to the therapeutic goods regulatory regime later in the year.

In particular, we intend to introduce further legislation to give effect to a new framework for the regulation of human cellular and tissue based therapies, foreshadowed as part of the ANZTPA process.

We will also be introducing legislation to give effect to the recommendations of the 2001 Galbally report on scheduling of medicines and poisons.

The Council of Australian Governments agreed in 2008 to support reforms to the national decision-making mechanism for scheduling of medicines and poisons suggested by the Productivity Commission. I expect that the National Coordinating Committee on Therapeutic Goods, a subcommittee of the Australian Health Ministers’ Advisory Council, will soon be releasing a discussion paper on the detailed model to be adopted.

As the Minister for Health and Ageing said when introducing the Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 in the Spring sittings last year, Australia has been served well by the TGA in the past.

It is important that the regulatory regime the TGA implements is kept up to date so that the TGA and the industry 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 the bill to the House.

Debate (on motion by Mr Wood) adjourned.