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Thursday, 30 September 1993
Page: 1553

Senator BOLKUS (Minister for Immigration and Ethnic Affairs and Minister Assisting the Prime Minister for Multicultural Affairs) (5.32 p.m.) —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


  This bill makes amendments to a number of Acts within the Health, Housing, Local Government and Community Services Portfolio. The amendments are largely of a minor procedural nature and are aimed at rectifying a number of drafting anomalies which have arisen.

Part 2 of the bill amends Part II of the Disability Services Act 1986 and, although of a minor nature, will improve the professional administration of the Disability Services Program. It will do so in two ways. Firstly, the amendment to section 14J of the Disability Services Act 1986 will make it clear that a statement which the Minister is permitted to make under the section, regarding funded organisations' breaches of prescribed standards under the Act, will not become the subject of a defamation action nor will any person who fairly reports or summarises the statement be liable for defamation. This amendment restates the common law. The provisions should save litigation costs.

Secondly, where an organisation's assets are to be transferred to another person, transferees will be asked under section 16 of the Disability Services Act 1986, as a condition of approval, to sign agreements acknowledging the extent of any Commonwealth equity in the transferred land, buildings and equipment. This will place transferees in the same situation as the original grantee with respect to the protection of Commonwealth equity.

Part 3 of the bill amends the Health Insurance Act 1973. The amendments in this Part correct anomalies arising from the passage of the Health Insurance (Pathology) Amendment Act (No. 2) 1991. In general these amendments are of a minor technical and administrative nature and do not have any substantive effect.

Clause 23DK extends the duty of responsibility for the keeping of relevant records to Approved Pathology Authorities who were the employers of an approved pathology practitioner at the time the service was rendered and the approved pathology practitioner is no longer employed by the approved pathology authority. It is impractical to require the approved pathology practitioner to continue to carry the responsibility for the retention of records, created at a time when he or she was in the employ of the approved pathology authority, after that employment has ceased.

Clause 23DNAA extends the exclusion of public authorities to include `joint ventures' between public authorities and private persons or corporations. Public authorities are funded through other arrangements. Without this amendment these `joint ventures' would be entitled to claim (additional) Medicare benefits as a private provider of pathology services. This is inconsistent with the intent of the Health Insurance Act 1973.

Clause 23DNC provides for a review of determinations made in respect to the allocation of specimen collection licences in special circumstances. Under the existing provisions of the Health Insurance Act 1973 determinations made under this section are not subject to review and may remain in force at the discretion of the licensee. This amendment is to implement measures to ensure that determinations made for the granting of specimen collection licences in special circumstances remains for as long as those `special circumstances' continue to exist.

Part 4 of the bill makes three amendments to the Hearing Services Act 1991. The first of these is to extend the definition of "eligible persons" to include holders of a "Dependent Treatment Entitlement Card". This will ensure that widows of veterans are adequately covered under this Act. The second and third amendments provides for the official symbol of Australian Hearing Services to be included within the protected symbol provisions of the Act and so prevent unauthorised use of the Authority's symbol.

Part 5 of the bill amends the National Health Act 1953. The amendment provides that a pharmacist who wishes to relocate a pharmacy must obtain approval in respect of the new premises, and that the Commonwealth cannot pay for pharmaceutical benefits which have been supplied from unapproved premises.

These provisions have been in the NHA for many years; however, prior to the passage of the pharmacy restructuring legislation in December 1990 they were not rigorously enforced, particularly in the case of comparatively short distance relocations. In any case, approval of relocations was virtually automatic provided that the requirements of State law were met. As a result, it is suspected that a number of pharmacists have relocated their businesses without obtaining the necessary approval.

Since the advent of the pharmacy restructuring, it has become necessary to enforce these provisions. The pharmacy restructuring guidelines provide for different rules to apply depending on the distance of a relocation, and also the distance to the nearest pharmacy is a consideration in granting an approval of a pharmacist or the payment of an essential pharmacy allowance.

Some eight cases where a pharmacist had relocated without approval came to light during 1991/92. In these cases act of grace payments and/or waivers of recovery were approved by the Minister for Finance.

The Health Insurance Commission now wishes to conduct a survey to establish with certainty the location of each approved pharmacist's premises. To ensure compliance with the survey by approved pharmacists, it wishes to assure them that they will not be penalised for unapproved relocations which occurred prior to the commencement of the pharmacy restructuring legislation.

The Department of Finance considers it inappropriate to continue to use the act of grace and waiver powers to deal with what could be a large number of unapproved relocations.

Thus to prevent an injustice in either seeking to recover moneys or to put a pharmacist out of business we are seeking to amend the NHA to deem as approved at their new premises those approved pharmacists who relocated without obtaining approval, prior to 18 December 1990 (the date of effect of legislation establishing the Pharmacy Restructuring Authority).

Part 7 of the bill repeals subsection 25(2) and section 38 of the Nursing Homes and Hostels Legislation Amendment Act 1986. These unproclaimed provisions relate to the regulation of government nursing homes under the Nursing Homes Assistance Act 1974. With the transfer of responsibility for the regulation of nursing homes to the National Health Act 1953, the provisions are no longer needed.

Part 8 of the bill introduces a number of changes to the Therapeutic Goods Act 1989. Clauses 29(h), 30, 31 and 32 will amend the Principal Act to facilitate the introduction of complementary State and Territory legislation that will support the regulatory framework set up under the Commonwealth's therapeutic goods legislation.

Amendments to the objects of the Therapeutic Goods Act have been included to clarify the respective roles of the Commonwealth and the States and Territories in establishing a uniform national system of controls over therapeutic goods.

Uniform regulation over the quality, efficacy and safety of therapeutic goods manufactured for supply and use in Australia cannot be achieved without the establishment of corresponding State and Territory laws that will adopt the Commonwealth's regulatory requirements in respect of appropriate standards, including manufacturing and advertising standards, for therapeutic goods. The States and Territories have agreed to set up complementary legislation to complement the Therapeutic Goods Act 1989. It is anticipated that state complementary legislation will be in place by as early as 1994. When this occurs, the amendments to the Principal Act dealing with complementary legislation will be activated by proclamation.

On 25 January 1993 Australia acceded to the Convention for the Mutual Recognition of Inspections in respect of the manufacture of pharmaceutical products. This convention allows for the mutual exchange of information on the manufacturing standards of manufacturers in the eighteen signatory nations. This will allow regulatory authorities in those countries to establish the acceptability of manufacturing standards and procedures used in the manufacture of imported pharmaceutical products without the need for overseas inspections to be undertaken by the importing country. Under this scheme export of Australian manufactured pharmaceutical products will be greatly enhanced. The inclusion of clauses 29(i), 37(b), 38(b), 47 and 50(d) will give effect to the convention.

Changes to the Therapeutic Goods Act are necessary to clarify the application of the Act to goods such as first aid kits and other packs containing mixed products. Such kits fall within the definitions of `therapeutic goods' and `therapeutic use' already existing in the Act.

These amendments make provision for the inclusion in the Register of kits, as a single entity, where the individual therapeutic goods contained in each kit have already been registered or listed in the Register. Provision is also made to enable a number of kits to be grouped together, as a `gazetted kits group', so that each kit may share a common listing number and sponsors of groups of kits need only pay one set of annual charges for maintaining listings of grouped kits in the Register.

The proposals have been discussed with companies supplying kits and the industry associations and have their agreement. Entry of kits on the Australian Register of Therapeutic Goods is necessary to enable complete traceability of therapeutic goods which are supplied either separately or in the kits.

Other amendments included in Part 8 of this bill seek to clarify the meaning and operation of the Therapeutic Goods Act and to address problems that have surfaced since the Act came into operation two and a half years ago.

The powers of the Secretary to declare goods exempt from the operation of the Act when labelled in a particular way is to be changed to close a potential loophole. Many goods may not qualify as therapeutic goods but for the way they are presented for supply. Therefore the Secretary may declare goods to be therapeutic goods where their presentation suggests any therapeutic use. At present sponsors could label their goods in a certain manner to avoid regulation, yet subsequently advertise or present their products as therapeutic goods. The amendment will preclude this from happening.

The definition of an `authorised person' is to be amended to make appropriately experienced members of the Australian Federal Police authorised persons for the purposes of Part 6 of the Principal Act. This will simplify administrative procedures when such officers are called upon to assist the Therapeutic Goods Administration with its investigations into breaches of the Principal Act.

The definition of manufacturing premises is to be amended to remove the restriction that such premises are to be confined to buildings on sites. This will allow manufacturing activities to be undertaken in places other than buildings, including mobile vans used for collecting blood plasma. Such places usually present no increased hazard to the products being manufactured, and should be permitted.

An amendment is required to enable an application fee to be charged for every application to add a new product into the Register, even though the new product comes within a gazetted therapeutic goods group. At present, sponsors of goods that fall within the description of a gazetted therapeutic goods group only pay one application fee to include all such products in the Register over a period of time. Agreement has been reached with industry on how the fee will apply and the levels of fee to apply.

An amendment is required to introduce a penalty for a sponsor who fails to provide information or who provides false or misleading information. This amendment addresses problems experienced by the Therapeutic Goods Administration in getting sponsors to provide information about the quality, safety or efficacy of therapeutic goods where there may be a concern over a product that has already been included in the Register.

At present the Act provides that in the event of entry and search of premises, evidence of the commission of offences may only be held for sixty days before commencement of prosecution. Experience in the first two and a half years of operation of the Act is showing this timeframe to be too restrictive to allow for analysis or testing of goods, compiling of briefs, and laying of charges. This amendment will permit the Therapeutic Goods Administration to make application to a magistrate for an extension to this sixty day period.

A related amendment will extend the 12 month period in which prosecutions for certain offences may be brought under the Act to two years.

Amendments to section 66 of the Principal Act will clarify the position that goods included in the Australian Register of Therapeutic Goods under the transitional arrangements, following the commencement of the Principal Act, may not necessarily have been evaluated or assessed. The transitional arrangements provided for a period of grace during which eligible sponsors of therapeutic goods could continue to supply unregistered and unlisted goods without committing an offence, whilst their goods were being included in the Register by the Therapeutic Goods Administration. Goods included in the Register as a result of transitional arrangements may nevertheless still be evaluated or assessed at a later date, to establish whether or not such goods should remain in the Register.

I commend the bill to the Senate and present the Explanatory Memorandum.


  I take pleasure in introducing the Therapeutic Goods (Charges) Amendment Bill 1993 to the Senate.

The Therapeutic Goods (Charges) Act 1989 (the Principal Act) imposes annual charges on the registration and listing of therapeutic goods, and on the licensing of manufacturers of therapeutic goods.

This bill makes amendments to the Principal Act that complement simultaneous changes to the Therapeutic Goods Act 1989 that are introduced in Part 8 of the Health and Community Services Legislation Amendment Bill (No. 2) 1993.

Part 8 of that amendment bill introduces a number of changes to the Therapeutic Goods Act 1989 to facilitate the introduction of complementary State and Territory legislation that will support the regulatory framework set up under the Commonwealth's therapeutic goods legislation. Details of these changes are contained in the Second Reading speech for that bill, and the associated Explanatory Memorandum.

The amendments to the Principal Act that I am now introducing address the remaining administrative implications of these changes.

The Principal Act will be amended to enable the Commonwealth to collect annual charges for maintaining registrations and listings of therapeutic goods, and for maintaining manufacturing licences, where such registrations, listings and licences have been effected on behalf of the States and Territories under complementary therapeutic goods legislation. Charges to be collected by the Commonwealth for the performance of functions on behalf of the States or Territories will be commensurate with the level of charges currently collected for the same activities performed in relation to therapeutic goods that are regulated under the Commonwealth's jurisdiction.

These amendments are subject to the establishment of corresponding State and Territory laws that will adopt the Commonwealth's regulatory requirements. It is anticipated that the first State and Territory complementary legislation will be in place by as early as 1994.

I commend the bill to the Senate and present the Explanatory Memorandum.


  The purpose of this bill is to extend the operation of the Australian Meat and Live-stock (Quotas) Act 1990 for a further three years until the end of 28 December 1996.

The Australian Meat and Live-stock (Quotas) Act 1990 provides the Australian Meat and Live-stock Corporation (AMLC) with the powers to establish quota schemes on the export of meat and live sheep from Australia in particular circumstances.

In the case of meat, the Act empowers the Corporation to operate quota schemes where restrictions are imposed, or likely to be imposed, on Australian exports by importing countries or by the Australian Government. Honourable Senators will be aware that the Corporation currently operates quota schemes for beef, mutton and goatmeat to the United States and for beef, sheepmeat and buffalo meat to the European Community in response to restrictions imposed by those markets.

Quota on meat must be allocated free of charge.

In each of the last three years, Australia has reluctantly agreed to restrain exports of meat to the United States to avoid imposition of quotas under the US Meat Import Law (MIL).

The imposition of so-called Voluntary Restraint Agreements not only disrupts our trade to the United States, which is a major market for beef worth in excess of $1.1 billion, but also creates uncertainty and impacts on the stability of Australia's domestic and other export markets. The MIL continues to be a trade irritant between Australia and the United States, and the Australian Government is seeking to achieve the elimination of the MIL as part of a successful outcome to the Uruguay Round.

Similarly, the EC imposes quotas on the import of beef and sheepmeat. Although the access level of Australian meat into the EC is relatively small (17,500 tonnes of sheepmeat, 6,032 tonnes of beef and 2,250 tonnes of buffalo meat), the Community represents an important market for high valued product, worth almost $146 million in 1991-92.

The Australian Meat and Live-stock (Quotas) Act 1990 also empowers the Corporation to operate quota systems on live sheep and lambs where the Corporation considers it in the best interests of the industry to do so. Quota on live sheep and lambs may be allocated free of charge or by auction, sale by tender or private sale.

The Corporation has not used the powers conferred on it in relation to live sheep, but once the live sheep trade is resumed to Saudi Arabia, these powers will give the Corporation the option, if necessary, to control the supply of live sheep for export to the Saudi Arabian market as part of a mutually satisfactory arrangement under which the trade could operate.

Australia voluntarily suspended the live sheep trade to Saudi Arabia in 1991 following a series of rejections supposedly for quarantine reasons. The trade was suspended with the full support of the industry to prevent damage to the international standing of the Australian livesheep industry as a supplier of quality livestock in the Middle East and to ensure that the Government's animal welfare obligations were met.

To ensure all quota arrangements are equitable, the Australian Meat and Live-stock Corporation Act 1977 requires the details of proposed quota allocation and management schemes to be set out in the AMLC's Corporate Plan, which must have Ministerial approval. These details must also be available to all exporters.

There is also a right of appeal to the Administrative Appeals Tribunal in respect of AMLC decisions regarding the period of validity of quotas and variations to quotas granted. The AMLC is also required to publish details of all quotas allocated in its Annual Report.

Passage of this bill will not effect Government expenditure and will have no staffing implications for the Commonwealth.

I commend the bill to Honourable Senators and I present the Explanatory Memorandum to this bill.

  Debate (on motion by Senator O'Chee) adjourned.

  Motion (by Senator Bolkus) agreed to:

  That the Australian Meat and Live-Stock (Quotas) Amendment Bill 1993 be listed on the Notice Paper as a separate order of the day.