Senator ABETZ (9:32 AM) —I table the explanatory memoranda relating to the bills and I move:

That these 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—

NATIONAL HEALTH AMENDMENT BILL (No. 1) 1999

This bill gives effect to a budget decision last year to address the problem of medication, subsidised under the Pharmaceutical Benefits Scheme (PBS), being taken or sent overseas either for sale or for use by persons not eligible to receive medication subsidised by the Australian taxpayer.

The bill prohibits the export of medications unless the medications are not prescription drugs; or they are prescription drugs but no Commonwealth benefit has been paid; or they are for the personal use of the person or another person accompanying the person. Based on data provided by the Australian Customs Service (ACS) and on information obtained by the Health Insurance Commission (HIC), it is estimated that medication subsidised to the value of some $20 million per annum is being exported inappropriately.

The bill provides the ACS with the power to detain medication in cases where the Customs officer forms the view that the medication is not for the personal use of the person who is either carrying or shipping the medication overseas. Medication detained by a Customs officer will be transferred to the HIC. The Customs officer has a discretion to detain only some of the medication, allowing the raveller to retain the remainder.

The HIC will be responsible for determining whether or not a Commonwealth benefit has been paid for the medication. The medication will be forfeited to the Commonwealth unless the medication is not a prescription drug; or that no Commonwealth benefit has been paid or is payable; or it is for the personal use of the person concerned.

The bill allows the Chief Executive Officer of the ACS to issue guidelines for the use of Customs officers relating to the examination of baggage, detention of medication, transfer of medication to the HIC, and copying and retaining documents provided in relation to the medication.

The bill further provides that the HIC may issue guidelines for the use of HIC officers when dealing with medication transferred from the ACS, dealing with claims for the return of medication, and dealing with the disposal of medication that has been forfeited to the Commonwealth.

Where the HIC establishes that the detained medications are prescription drugs, it must notify the exporter that an application may be made within 60 days for the return of the medication. The HIC must consider any submissions seeking the return of the medication. In order for the medication to be forfeited and destroyed, the HIC must apply to a court for an order authorising the proper destruction of the medication.

These provisions are meant to address situations where a person is attempting to carry or send large quantities of medication overseas; quantities which cannot reasonably be considered to be for personal use; where the prescription labels do not relate to the person who has possession or control of the medication; or where the prescription labels have been removed or defaced so as not to allow identification of the person to whom they were supplied.

The bill specifies a formula, for most medication allowing at least 12 months' supply, under which the possession or attempted export of a greater quantity constitutes a prima facie offence. The bill does not affect travellers who are entitled to medication subsidised under the PBS and which are for the traveller's personal use or are for the personal use of a person accompanying the traveller.

The National Health Act 1953 currently prohibits a person from disposing of a PBS medication in a manner not intended in the prescription. This includes selling or exporting the medication overseas. The bill will now allow the HIC to address the situation where the subsidised medication is in the possession of another person or is being forwarded overseas by a person for whom the medication was not prescribed.

The bill has been the subject of extensive consultation between the HIC, the ACS, the Department of Health and Aged Care, the Attorney-General's Department and the office of Director of Public Prosecutions. The work on this bill was initiated by a recommendation of the House of Representatives Standing Committee on Family and Community Affairs in its report Concessions—Who benefits?

In conjunction with this legislation, the HIC will undertake action to inform potential travellers, prescribers and pharmacists of the amendments to the National Health Act 1953. The information will be advertised in professional and travel publications, on ethnic radio and in ethnic newspapers.

I now commend the bill.

AUSTRALIAN CAPITAL TERRITORY (PLANNING AND LAND MANAGEMENT) AMENDMENT BILL 1999

The purpose of this bill is to increase the attractiveness of the Australian Capital Territory to potential investors by removing the perceived disincentive to business and other investment brought about by the limit of land tenure to 99-year estates, as distinct from freehold title enjoyed elsewhere in Australia.

The objectives of strengthening land tenure security and allowing the ACT Legislative Assembly to extend ACT leases from 99 years to 999 years were stated in the Coalition Policy on the National Capital in both 1996 and 1998.

Section 9 of the Seat of Government (Administration) Act 1910 provides that no Crown lands in the Territory may be sold or disposed of for freehold estates.

The Australian Capital Territory (Planning and Land Management) Act 1988 provides for land in the act to be National Land or Territory Land. National Land is land so declared by the Commonwealth Minister as land used or intended to be used by or on behalf of the Commonwealth. Land that is not National Land is Territory Land. The ACT Government manages Territory Land on behalf of the Commonwealth and may grant, dispose of, acquire, hold and administer estates in Territory Land.

The ACT Government sought an amendment to the Australian Capital Territory (Planning and Land Management) Act 1988 to enable it to issue leases for a maximum term of 999 years. The Chief Minister, Mrs Carnell, has cited the 99-year limit as antiquated and unduly restrictive. ACT business representatives have supported the proposed amendment. A regulation impact statement is included in the explanatory memorandum.

This bill is consistent with the Australian Capital Territory being a self-governing territory.

The proposed amendment was first introduced into the House of Representatives as the Australian Capital Territory (Planning and Land Management) Amendment Bill 1997 on 4 December 1997 and was passed by the House without amendment on 10 March 1998. It was introduced into the Senate on 12 March 1998.

The bill was referred to the Senate Rural and Regional Affairs and Transport Legislation Committee on 12 March 1998. The committee tabled its report in April 1998 with the majority recommending that the bill be passed without amendment. The committee concluded that the bill is an appropriate form of enabling legislation allowing the ACT Legislative Assembly to enact a change of leasehold term from a maximum possible term of 99 years to 999 years.

Following its inquiries of the ACT Government as to the machinery proposed for administration of any changes to the term of ACT leasehold approved by the Commonwealth Parliament, the committee was satisfied that the passage of the bill should be supported.

Effect of the bill

The proposed amendment will increase the maximum permissible limit for the grant of new estates in Territory Land to 999 years. The bill will not provide for automatic extension of existing estates. A leaseholder seeking a term longer than 99 years will need to apply to the ACT Government for a new grant.

The ACT Government has indicated that a modest administrative charge will apply to the grant of new leases to existing leaseholders, provided no terms of the lease, other than the lease period, are changed.

The proposed amendment removes the reference to `or such longer period as is prescribed' so that no terms of estate greater than 999 years will be possible.

The Regulations currently applicable which relate to 999-year leases granted for tertiary education or church purposes prior to the introduction of Self-Government in the ACT will be unaffected by the proposed amendment.

The act is proposed to take effect upon receiving the Royal Assent.

Financial Impact

The proposed amendment will have no direct impact on Commonwealth revenue or outgoings. However, it is intended that the amendment will bring positive effects to the ACT economy by increasing the Territory's attractiveness to investors.

THERAPEUTIC GOODS LEGISLATION AMENDMENT BILL 1999

This bill represents an important moment in the regulation of therapeutic goods in Australia. This bill encompasses the first component of a package of reforms designed to provide a new and appropriate framework for the regulation and management of complementary medicines. This bill also makes a number of more general amendments to improve the overall efficiency and effectiveness of the Therapeutic Goods Act 1989.

It is estimated that over 60 percent of Australians use complementary health care products at least once a year. These include vitamins, minerals, herbal, naturopathic and/or homoeopathic preparations with therapeutic properties.

There are now around 17,000 such products on the Australian Register of Therapeutic Goods and an estimated 6,000 complementary medicine practitioners (not including massage therapists) operating in Australia.

In December last year I announced the formation of a Working Party, bringing together industry representatives, consumers and Government, to develop reforms in the regulation of complementary medicines. Along with many of my colleagues on both sides of the Senate, I considered this extremely important given the growing use and acceptance of complementary health care products in this country and throughout the world.

Both government and industry have been struggling to balance the need to improve market access with the need to uphold consumer confidence. Reviewing advertising regulations, substantiation of therapeutic claims and post market vigilance are critical issues to government, industry and consumers alike. It is also essential to secure the ongoing involvement of the complementary medicines industry in providing advice to government and evaluating and regulating complementary medicines.

I am delighted that the Working Party was able to address these issues and agree on a well considered and comprehensive framework for complementary medicines which addresses market access, the ongoing control of complementary medicines and most importantly the maintenance of public health and safety through co-operation and regulation.

The package of reforms for complementary medicines includes some legislative changes, some changes to the Therapeutic Goods Act regulations, major administrative reforms plus information and consultative initiatives.

The bill that I am presenting today includes the legislative component of complementary medicine reforms. It ensures that through appropriate regulation, the Australian public can be confident that the medicines they consume and medical devices that they use are safe, effective and of a high quality.

In summary, the bill makes amendments to the Therapeutic Goods Act 1989 in three key respects:

Firstly , it amends key definitions in the act to provide greater clarity and certainty in relation to the application of the legislation.

Secondly, it includes amendments which acknowledge the shift of focus from pre-market clearance to post market vigilance for low-risk `listable' goods. This is achieved by, for example, providing a more streamlined and efficient process to enable sponsors to market low risk products without undue delay while ensuring that consumers continue to be protected from unsafe products.

Thirdly , this bill includes a new part in the act that establishes as a statutory body, the existing Complementary Medicines Evaluation Committee.

The opportunity has also been taken, with agreement from industry, to address other matters in the bill including the establishment of the existing National Drugs and Poisons Schedule Committee as a statutory committee and the inclusion of a new Part which describes penalties and offences in relation to the publication of advertisements which have not been pre-cleared.

Allow me to explain the key components of the bill in a little more detail.

Amendments to Definitions

The bill amends key definitions in the Therapeutic Goods Act 1989 (the act) to provide a better interface between foods, complementary medicines and other medicines such as over the counter and prescription medicines. Changes have been made to reduce confusion at the food-therapeutic goods interface and make it clear when a good is a therapeutic good (regulated by the Therapeutic Goods Administration) and when it is a food (to be dealt with by the Australian and New Zealand Food Authority).

Enhanced market access and increased post market vigilance

A number of amendments to the bill operate in conjunction with each other to improve market access for complementary medicines while at the same time increasing post market monitoring to ensure that consumers continue to access only safe and reliable products.

At present, once the TGA is satisfied that a substance is sufficiently low risk for its intended purpose, such goods may be eligible for `listing' in the Australian Register of Therapeutic Goods (ARTG). These goods are referred to as `listable' goods. However, changes to the documentation of goods that qualify as `listable' goods requires an amendment to the Therapeutic Goods Regulations. This is a cumbersome process that often fails to accommodate the commercial realities involved in enabling low-risk products to become publicly available.

To address this problem, the amendments contained in this bill propose the use of a gazettal notice by the Minister in lieu of an amendment to regulations. This will enable a quicker, more responsive process to be adopted to achieve the same results—that is, low risk products gaining swift access to the market and consumers having access to new products more quickly.

Quicker market access does not mean marketing of less safe products or misleading marketing claims. The bill confirms the existing condition that requires the sponsor to hold evidence supporting any claims.

This supporting evidence will not be required as a matter of routine but will be called upon in cases where there is a clear public health or safety matter at issue or where there has been deliberately or recklessly misleading information provided to the public about a product. The level of evidence that will be required, will be directly related to the risk associated with the product and the nature of the claim made about the product. However, it is important to note that testimonials alone are not acceptable proof of efficacy. The Complementary Medicines Evaluation Committee will advise the TGA and sponsors on appropriate levels of evi dence for claims made for various substances and products.

The combination of these measures will help facilitate growth in the area of complementary medicines and promote public confidence that the complementary health care products marketed in Australia are safe, effective and of a high quality.

Complementary Medicines Evaluation Committee

The Complementary Medicines Evaluation Committee (CMEC) was established in December 1997. This bill will strengthen and enhance the standing of the Committee and complementary health care products generally by establishing CMEC as a statutory committee.

The establishment of CMEC as a statutory committees under the Therapeutic Goods Act 1989 is an acknowledgment of the growing significance of this industry and the need to improve the government's access to expertise in this area. This will provide an opportunity for expert, experienced and appropriate input into the evaluation of medicines and for important issues to be discussed amongst peers both within and outside the public sector.

This legislative change, will also be accompanied by a range of administrative reforms aimed at improving the management of complementary medicines and ensuring the involvement of industry and consumers in policy making. For example, I will be setting up an Office of Complementary Medicines within the Therapeutic Goods Administration, responsible for the regulation of the complementary medicines industry and staffed by senior and experienced personnel. I will also be inviting consumer and industry groups to join a Complementary Health Care Consultative Forum.

Another critical issue which the government intends to address through administrative reform is the advertising of therapeutic goods. It is recognised by both the TGA and industry that the existing Therapeutic Goods Advertising Code is somewhat outdated and no longer meets the needs of industry or government. The TGA has therefore undertaken to conduct a comprehensive review of the Code and the guidelines issued in relation to the Code.

The aim of the review will be to create a system of regulation in relation to advertising which is: simple; easily understood by advertisers, sponsors and the media; consistent with modern best practice; and capable of addressing a range of products and claims so that consumers can be appropriately informed. The review will, of course, be characterised by extensive consultation and expert input, particularly from the Therapeutic Goods Advertising Code Council.

As I mentioned earlier, in addition to the reforms proposed in respect of complementary medicines, the opportunity has also been take to make some more general amendments which improve the application of the therapeutic goods legislation in respect of all medicines and devices.

One such amendment formalises existing arrangements in relation to the scheduling of drugs and poisons. The bill creates a new Part in the act which establishes the existing National Drugs and Poisons Schedule Committee. The Committee's functions include: making decisions in relation to the classification and scheduling of substances; maintaining the Poisons Standard; and providing advice to government on legislative restrictions and policies in relation to substances.

It should be noted that this Part of the bill, including the definitions adopted specifically for this Part, do not relate to the reforms in respect of complementary medicines. The Part focuses specifically on the work of the existing Commonwealth/State body known as the National Drugs and Poisons Schedule Committee.

Another more general amendment included in the bill relates to offences and penalties for publication of advertisements in mainstream print media for which prior approval for such publication has not been obtained.

These offences and penalties previously resided in the Therapeutic Goods Regulations. They are however, much more appropriately placed in the Therapeutic Goods Act itself.

The penalties have been increased from $1,100 to $11,000 to bring them more in line with penalties for the broadcast of product advertisements and to reflect the Government's commitment to ensuring that advertisements which have a wide audience have been appropriately cleared.

In closing, I believe that this bill introduces important amendments which will improve the capacity of the legislation to appropriately regulate complementary health care products and other medicines and other therapeutic goods. The reforms provide a unique opportunity to achieve a co-operative approach to health care and provide assurances to the Australian public that the medicines they consume are safe, effective and of a high quality.

I commend the bill to you.

Ordered that further consideration of the second reading of these bills be adjourned until the first day of sitting in the winter sittings of 1999, in accordance with standing order 111.

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