Mark Butler (Port Adelaide, Australian Labor Party, Parliamentary Secretary for Health) Share this | Link to this | Hansard source

I move:

That this bill be now read a second time.

This bill is the third in a series of bills to implement important and much-needed amendments to the Therapeutic Goods Act 1989. The bill reflects the government’s commitment to ensuring the ongoing safety and efficacy of therapeutic goods available in Australia while reducing the regulatory burden on the therapeutic goods industry.

Many of the amendments in the government’s therapeutic goods regulatory reform program were to have been adopted as part of the legislation underpinning the proposed Australia New Zealand Therapeutic Products Authority, or ANZTPA.

One such amendment is to provide for the separate scheduling of medicines and chemicals.

I should begin by explaining that scheduling is a collaborative process involving both the Commonwealth and the states and territories. A committee established under Commonwealth law with state and territory representatives makes decisions that are then implemented through state and territory legislation.

Scheduling is the process by which substances that can be harmful if not used or kept correctly are grouped into categories, known as schedules. Specific requirements are then attached to the schedules under state and territory law regarding supply, availability and oversight of use to support the safe and effective use of these substances. This then has a flow-on effect on the supply, availability and use of medicines and chemicals that contain scheduled substances.

Scheduling decisions are recorded in a document known as the Poisons Standard, which brings together the names and details of the substances that have been scheduled and categorises these by schedule. For example, schedule 2 covers medicines that can be purchased only from a pharmacy whereas schedule 6 covers poisons that are available for purchase from a wide variety of retail outlets.

While the current scheduling arrangements have worked effectively for many years, there are ways in which they can be improved.

Areas for improvement were identified in the Council of Australian Governments’ Review of Drugs, Poisons and Controlled Substances Legislation, undertaken by Ms Rhonda Galbally some eight years ago. The recommendations from this review were provided to the Australian Health Ministers’ Conference (AHMC) in 2001 and were the basis for further consideration by the Commonwealth in partnership with the states and territories in the development of ANZTPA legislation.

The recommendations from the review were wide ranging and many have already been implemented, including recommendation 6, which recommended that independent, comprehensive and quality information be provided to consumers to support safe and effective use of medicines. This has been implemented through a package of measures including through the provision of consumer medicine information to patients on dispensing of a script.

A key recommendation from the review was to provide separate scheduling arrangements for medicines and chemicals to reflect the different uses and environments in which these substances are made available and used. The Australian Health Ministers Conference agreed to implement this recommendation by providing for the Secretary of the Department of Health and Ageing to be the final decision maker for scheduling decisions, taking into account advice provided by these separate medicines and chemicals advisory committees.

The Productivity Commission’s research report on chemicals and plastics regulation, which was published in July last year, supported this by recommending that these new scheduling arrangements be implemented as soon as feasible.

The amendments in schedule 1 to the bill deliver on the government’s commitment to implement the recommendations from these reviews through new scheduling arrangements. The new arrangements have also been informed more recently by additional consultation undertaken by the Therapeutic Goods Administration with industry and other interested parties.

One key element from the existing scheduling arrangements will be retained—the cooperative arrangement we have with the states and territories. This is necessary under the Constitution to achieve scheduling implementation uniformly across all states and territories. It has served Australia well in the past. The government will, therefore, continue to work in partnership with our state and territory counterparts under the new arrangements.

The bill will replace the existing National Drugs and Poisons Scheduling Committee that makes scheduling decisions with two new expert advisory committees, which will provide recommendations and advice to the Secretary of the Department of Health and Ageing to inform her in making scheduling decisions.

The Advisory Committee on Medicines Scheduling will be able to provide recommendations and advice about substances used in medicines, while the Advisory Committee on Chemicals Scheduling will advise on substances such as agricultural, domestic and veterinary chemicals.

Decisions of the secretary will then be incorporated into the Poisons Standard. This will be retained as a single complete reference for the scheduling classifications of both medicinal and chemical substances.

Reflecting the important collaborative Commonwealth-state/territory arrangements for scheduling, the committees will include members from the Commonwealth and each of the states and territories as well as other experts to be provided for in the subordinate legislation.

The new arrangements will provide greater clarity and opportunity for individuals to make applications to the secretary to seek amendment to the scheduling of a substance, such as to request that a substance be down-scheduled to a less restrictive schedule. In considering these applications the secretary will be able to seek the advice of either or both the medicines or chemicals advisory committee. She may also seek advice from another committee or another person, such as from a recognised international expert, if that would be useful.

The transitional provisions will ensure that applications currently under consideration by the NDPSC are able to be transferred across for consideration under the new arrangements and that any recommendations made by that committee will be taken into account by the secretary. This will ensure a smooth transition to the new arrangements upon their commencement on 1 July 2010. This timing will also allow development of the supporting subordinate legislation.

Moving on, schedule 2 of the bill provides arrangements to enable the secretary to declare purposes for which kinds of medical devices cannot be included in the register. Purposes will be precluded where such a use would pose a risk to public health or where it would be otherwise inappropriate.

Presently, as long as a medical device satisfies all of the application and certification requirements under the act it is included in the register. That is, as long as the device works correctly and is manufactured appropriately it can be made available in Australia.

However, a device may be entirely effective and of high quality but the use it is intended for may jeopardise the health of the person using it.

The amendments in this schedule will address this by ensuring that in considering an application to include a device in the register the secretary must give consideration to its intended use.

If the intended use of the device is solely an excluded use the device will not be able to be included in the register. Where a device has multiple uses, including both prohibited and appropriate uses, the device will be able to be included in the register subject to the condition that it is not to be made available or indicated to be used for the prohibited use.

Recently the government has become aware of ‘do-it-yourself’ home testing kits for serious conditions or illnesses. This is a concern, as people need the support and expert clinical advice from a doctor or other appropriately qualified health professional to understand the results of a test for a serious condition and their options for clinical care.

There are also some conditions which are required to be notified to health authorities for public health reasons, such as HIV. Notifications are made by the patient’s doctor and are treated in the strictest confidence. It is unlikely that patients self-testing at home will either be aware of the notification requirement or willing to notify their test result.

The amendments in this bill will ensure that medical devices are only available for appropriate purposes to support high-quality, safe medical care.

Finally, schedule 3 includes provisions intended to make a number of minor amendments to improve the operation of the act.

The amendments under part 1 of schedule 3 will enable the TGA to consult with and seek advice from the Gene Technology Regulator about applications for the listing or registration of therapeutic goods that are genetically modified organisms, GMOs, or that contain GMOs.

These amendments simply augment the current provisions under sections 30C and 30D of the act, which allow the TGA to consult with the Gene Technology Regulator regarding genetically modified products. These products, by definition, do not include GMOs and it is therefore necessary to amend these sections to allow consultation on any genetically modified therapeutic good.

Schedule 3 also ensures that advertising of medicines and other therapeutic goods is only for the purpose that was approved when the good was included in the register.

Presently subsection 22(5) of the act makes it an offence to advertise a therapeutic good inappropriately but only if the person advertising it is the sponsor. Therefore, a sponsor may ask another person to advertise a medicine for them for an unapproved purpose and that person would not be subject to the offence provision. This is concerning as such advertising may be relied upon by Australians in choosing medicines and other therapeutic goods and the unapproved purpose being advertised may not be safe or effective.

This schedule addresses this by extending the offence provision to any person who inappropriately advertises a therapeutic good, not just the sponsor.

Part 1 of schedule 2 updates a delegation provision under section 57 of the act to remove the reference to a specific branch of the TGA and the replacement provision enables this to be specified in the regulations. This will ensure that delegation arrangements can keep pace with administrative changes at the TGA. The level of the person to whom the secretary can delegate her decision making power to will not be affected by this amendment.

Finally, the regulations currently require that certain medicines, mainly over the counter medicines, are required to include advisory statements on their labels to assist consumers in choosing the most appropriate medicine and using it safely and effectively.

The bill improves the transparency of these requirements by empowering the minister to specify them in a legislative instrument. Any medicine that the regulations list for the purposes of the legislative instrument will now be required to include the advisory statements relating to it that are set out in the instrument.

The sorts of advisory statements that labels will be required to include will depend on the medicine but will be familiar to us all and include such statements as, ‘If symptoms persist beyond 5 days consult a doctor’. By setting out standardised statements this ensures that consumers receive consistent information and advice in language that is easy to understand and clear to read.

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, as foreshadowed as part of the ANZTPA process.

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 this bill to the House.

Debate (on motion by Mr Pearce) adjourned.