A New Tax System (Australian Business Number) Bill 1998
      Introduction 
      The Committee dealt with this bill in Alert Digest No. 1 of 1999, 
        in which it made various comments. The Assistant Treasurer has responded 
        to those comments in a letter dated 10 March 1999. A copy of the letter 
        is attached to this report. An extract from the Alert Digest and 
        relevant parts of the Assistant Treasurer's response are discussed below. 
      
      Extract from Alert Digest No. 1 of 1999 
      This bill was introduced into the House of Representatives on 2 December 
        1998 by the Treasurer. [Portfolio responsibility: Treasury] 
      One of a package of 16 bills to reform the taxation system, the bill 
        proposes to introduce the Australian Business Number (ABN) as a single 
        business identifier. An ABN will be available to all companies registered 
        under the Corporations Law, government and business entities and entities 
        which require to be registered for the Goods and Services Tax, such as 
        charitable and religious institutions. 
      Reversal of the onus of proof
      Subclause 16(3)
      Proposed clauses 14 and 15 of this bill impose an obligation to notify 
        the Registrar of the Australian Business Register of relevant information 
        and of changes in that information. Proposed subclause 16(1) imposes this 
        obligation on each member of a partnership, but states that it may be 
        discharged by any of the partners. Similarly, proposed subclause 16(2) 
        imposes this obligation on each member of the management committee of 
        an unincorporated association, but states that it may be discharged by 
        any of those members. 
      Proposed subclause 16(3) goes on to provide a defence for persons prosecuted 
        for such offences under section 8C of the Taxation Administration Act 
        1953 as members of partnerships or unincorporated associations. In 
        general terms, subclause 16(3) reverses the onus of proof, requiring those 
        prosecuted to prove that they were not involved or knowingly concerned 
        in the conduct which led to the commission of the offence. 
      This provision has been included because section 8C of the Taxation 
        Administration Act 1953 would otherwise impose strict criminal liability 
        on such persons. However, a number of other matters are not clear from 
        the structure of the legislation. For example, the bill does not canvass 
        liability or the availability of defences where such offences are committed 
        by other legal entities such as trusts, incorporated associations or corporations. 
        Similarly, it is not clear whether this approach to liability and defences 
        is characteristic of the approach taken elsewhere in the taxation legislation, 
        or has been developed with specific reference to these offences. 
      In general terms, it is not clear whether those who might seek to use 
        the proposed subsection 16(3) defences are being treated more or less 
        favourably than, or the same as, others who commit these offences on behalf 
        of other legal entities, or others who commit similar offences under other 
        parts of the taxation legislation. The Committee, therefore, seeks 
        the Treasurer's advice on these matters. 
      Pending the Treasurer's advice, the Committee draws Senators' attention 
        to the provisions, as they may be considered to trespass unduly on personal 
        rights and liberties in breach of principle 1(a)(i) of the Committee's 
        terms of reference. 
      Relevant extract from the response from the Assistant Treasurer 
      
      Clauses 14 and 15 of the Bill impose obligations on Australian Business 
        Number (ABN) registered entities to notify the Australian Business Registrar 
        of relevant information and changes to that information. Subclauses 16(1) 
        and 16(2) extend those obligations to cover each member of a partnership 
        or each member of a management committee of an unincorporated association. 
        That is, the subclauses extend the obligations to legal entities who can 
        be prosecuted for an offence (partnerships and unincorporated associations 
        cannot be prosecuted for an offence). Any one of those members can discharge 
        the obligation. 
      As the Bill will be an Act which is taxation law, the provisions of the 
        Taxation Administration Act 1953 (TAA) will apply. 
        Where the obligations under clauses 14, 15 and 16 are not met, there will 
        be an offence under section 8C of the TAA. 
      However, the Bill does not, of itself, create any offence. Nor does it 
        reverse the onus of proof set out under section 8C, ie, that it is incumbent 
        upon the Commissioner of Taxation to prove that the person was capable 
        of providing the required information. 
      Because of the need to extend the information obligations to cover each 
        member of a partnership or each member of a management committee of an 
        unincorporated association, the Bill provides an additional safeguard 
        to those members. Essentially, the proposed defence provided by subclause 
        16(3) of the Bill ensures that no offence will have occurred where the 
        person proves that they did not knowingly fail to give the information. 
        Of course, this defence will not be necessary if the Commissioner of Taxation 
        cannot prove that the person was capable of providing the required information. 
      
      Your Committee has indicated that they are concerned that the provisions 
        may trespass unduly on personal rights and liberties. Four concerns which 
        lead to this belief were advanced. 
      The first concern is that subclause 16(3) of the Bill reverses 
        the onus of proof. That is, that it is up to the person, not the 
        Commissioner to prove that an offence has occurred. This concern is unfounded 
        as it remains the Commissioner who must prove that an offence has been 
        committed, that is, that the person was capable of providing the information 
        and did not do so. The Bill merely provides an additional defence. That 
        defence requires a knowledge of the person's mind. Such knowledge is not 
        provable by the Commissioner. 
      The second concern is that the Bill does not deal with the liability 
        for offences (and any defence) for entities other than partnerships and 
        unincorporated associations. This concern is also unfounded. The Bill 
        clearly notes at the end of clause 15 that section 8C of the TAA will 
        apply to any entity registered for the ABN if it does not comply. As noted 
        above, the Commissioner of Taxation continues to have the onus of proving 
        the offence. 
      The third concern is whether the Bill's approach to liability and defences 
        is the approach taken elsewhere in the taxation legislation, or is this 
        a new approach. Clearly, the use of section 8C of the TAA is the normal 
        approach throughout the taxation legislation. In regard to the defences 
        for members of partnerships and unincorporated associations, the approach 
        taken in the Bill is also common in the taxation legislation. For example, 
        sections 220AZF and 220AZG of the Income Tax Assessment Act 1936 
        or sections 165 and 166 of the Fringe Benefits Tax Assessment Act 1986 
        provide virtually identical defences for members of partnerships and unincorporated 
        associations to the defences provided under subclause 16(3) of the Bill. 
      
      The fourth concern is that the Committee is unsure whether subclause 
        16(3) of the Bill treats members of partnerships or unincorporated associations 
        in a more or less favourable way in comparison to others, wither within 
        this Bill or within taxation legislation generally. It is clear from the 
        above that members of partnerships or unincorporated associations have 
        an advantage over most other persons, as they have an additional defence 
        open to them when being prosecuted under section 8C of the TAA which is 
        not open to most other persons being prosecuted under that section. 
      In summary, I do not consider that the Bill's provisions unduly trespass 
        on personal rights and liberties. 
      The Committee thanks the Assistant Treasurer for this detailed response. 
      
       
      Migration Legislation Amendment Bill (No. 2) 1998
      Introduction 
      The Committee dealt with this bill in Alert Digest No. 1 of 1999, 
        in which it made various comments. The Minister for Immigration and Multicultural 
        Affairs has responded to those comments in a letter dated 23 March 1999. 
        A copy of the letter is attached to this report. An extract from the Alert 
        Digest and relevant parts of the Minister's response are discussed 
        below. 
      Extract from Alert Digest No. 1 of 1999 
      This bill was introduced into the Senate on 3 December 1998 by the Parliamentary 
        Secretary to the Minister for Communications, Information Technology and 
        the Arts. [Portfolio responsibility: Immigration and Multicultural Affairs] 
      
      The bill proposes to amend the Migration Act 1958 to: 
      
        - ensure that provisions of the Human Rights and Equal Opportunity 
          Commission Act 1986 and the Ombudsman Act 1976 do not apply 
          to persons who are in immigration detention, having arrived in Australia 
          as unlawful citizens, unless such persons themselves initiate a written 
          complaint to HREOC or orally or in writing to the Ombudsman; and 
 
        - clarify the duties of the Minister and officials concerning advice 
          relating to applications for visas and on access to legal and other 
          advice. 
 
      
      Introduction
      In general terms, this bill is similar in form to the Migration Legislation 
        Amendment Bill (No 2) 1996 (the 1996 bill), which was introduced 
        into the Senate on 20 June 1996, and on which the Committee reported in 
        its Sixth Report of 1996. 
      Retrospective effect and the current bill
      Clause 2
      Clause 2 of the 1998 bill provides that the proposed amendments are to 
        commence on the date the bill was introduced into the Senate (ie 3 December 
        1998). In commenting on this provision, the Committee notes that, for 
        more than 2 years between 1996 and 1998, the law was apparently administered 
        on the basis of legislation which was said to operate retrospectively 
        and yet was never passed by the Parliament. It is conceivable that such 
        a situation might again arise in the case of the present bill. 
      It is also conceivable that the bill may ultimately be passed in an amended 
        form. Again, this may have implications for the way the law will be administered 
        in the period between the introduction of the bill, and its final passage 
        through the Parliament. 
      The Committee reiterates that it is opposed in principle to retrospective 
        legislation which detrimentally affects rights. The Committee considers 
        that, in principle, legislation which changes the nature of people's access 
        to justice should commence from the date it is passed by the Parliament 
        rather than the date it is introduced into the Parliament. Given the experience 
        of the 1996 bill, the Committee seeks the Minister's advice on 
        the reasons for making this bill operative from its introduction rather 
        than its passage, and on the implications of this for Departmental officers 
        and administration should the bill again not be passed, or be passed in 
        an amended form. 
      Pending the Minister's advice, the Committee draws Senators' attention 
        to this provision, as it may be considered to trespass unduly on personal 
        rights and liberties, in breach of principle 1(a)(i) of the Committee's 
        terms of reference. 
      Relevant extract from the response from the Minister 
      The Committee has noted that the Bill commences on the date of its introduction 
        into Parliament, rather than its passage. The Committee believes that 
        this may be considered to trespass unduly on personal rights and liberties, 
        in breach of principle 1(a)(i) of the Committee's terms of reference. 
      
      This Bill is largely the same as the Migration Legislation Amendment 
        Bill (No. 2) 1996, which was before the last Parliament. That Bill was 
        introduced on 20 June 1996 and had a commencement date linked to my public 
        announcement on the issue on 19 June 1996. 
      The present Bill has a commencement date of 3 December 1998, being the 
        date of the Bill's re-introduction into the Senate. This date was chosen 
        to take into account the two-year delay associated with the previous Bill 
        and because there had been no events between 20 June 1996 and 3 December 
        1998 that could have required retrospective validation. 
      I assure the Committee that making the Bill operative from the date of 
        introduction rather than its passage does not have implications for Departmental 
        officers or administration as both the Human Rights Commissioner and the 
        Commonwealth Ombudsman have given undertakings that they will carry out 
        the functions under their respective legislation as if the Bill has been 
        passed. 
      I trust that these comments will be of assistance to the Committee. 
      The Committee thanks the Minister for this response, and accepts his 
        assurance that there were no events between 20 June 1996 and 3 December 
        1998 that could have required retrospective validation. The Committee 
        also notes the Minister's assurance that making the bill operative from 
        the date of its introduction rather than its passage has no implications 
        for Departmental officers or administration as both the Human Rights 
        Commissioner and the Commonwealth Ombudsman have given undertakings that 
        they will carry out the functions under their respective legislation as 
        if the Bill has been passed. However, the Committee continues to 
        be concerned at the potential implications of the bill's approach to its 
        commencement. 
      For example, the Committee notes recent media reports that 95 illegal 
        immigrants had entered Australia or been found in Australian waters at 
        Cairns, Gove, Christmas Island and off the coast of Darwin in February 
        and March of this year. The Committee would appreciate the Minister's 
        further advice as to whether this bill is currently being applied 
        to these people, and to the functions of the Human Rights Commissioner 
        and the Commonwealth Ombudsman under their respective legislation in relation 
        to these people. 
      Pending the Minister's advice, the Committee continues to draw Senators' 
        attention to this provision, as it may be considered to trespass unduly 
        on personal rights and liberties, in breach of principle 1(a)(i) of the 
        Committee's terms of reference. 
       
      Sales Tax Legislation Amendment Bill (No. 1) 1998
      Introduction 
      The Committee dealt with this bill in Alert Digest No. 1 of 1999, 
        in which it made various comments. The Assistant Treasurer has responded 
        to those comments in a letter dated 10 March 1999. A copy of the letter 
        is attached to this report. An extract from the Alert Digest and 
        relevant parts of the Assistant Treasurer's response are discussed below. 
      
      Extract from Alert Digest No. 1 of 1999 
      This bill was introduced into the House of Representatives on 3 December 
        1998 by the Minister for Financial Services and Regulation. [Portfolio 
        responsibility: Treasury] 
      The bill proposes to amend the following acts: 
      Sales Tax Assessment Act 1992 and Sales Tax (Exemptions 
        and Classifications) Act 1992 to provide exemptions from sales 
        tax for: 
      
        - satellites, space launch vehicles and other commercial space equipment; 
          and 
 
        - certain goods imported by, or on behalf of, non-Australian Sydney 
          2000 Olympic and Paralympic Family Members and delegations and participants 
          in the Sydney 2000 Olympics, Paralympic and associated events; and 
 
      
      Sales Tax Assessment Act 1992 to: 
      
        - change the sales tax rules for the computer industry; and 
 
        - provide that goods imported into Australia under a temporary importation 
          exemption, used in Australia, exported and then re-imported are subject 
          to sales tax at the time of the later importation. 
 
      
      Indeterminate commencement
      Subclause 2(2)
      Subclause 2(2) provides that a number of items in Schedule 2 are to commence 
        on a day to be fixed by Proclamation, with no further time fixed for automatic 
        commencement or repeal. 
      The Committee has frequently commented on such provisions in the context 
        of Drafting Instruction No 2 of 1989 issued by the Office of Parliamentary 
        Counsel. This Drafting Instruction states that, as a general rule, 
        a restriction should be placed on the time within which an Act should 
        be proclaimed. The commencement clause should fix either a period or a 
        date after Royal Assent, together with a provision stating that, if no 
        proclamation has been made, the Act either commences at the fixed time, 
        or is to taken to be repealed at that time. The Drafting Instruction 
        concludes that clauses providing for commencement by proclamation without 
        the restrictions mentioned above should be used only in unusual 
        circumstances, where the commencement depends on an event whose timing 
        is uncertain. 
      Paragraph 3.13 of the Explanatory Memorandum to this bill states that 
        the new rules for exported goods will start from a date to be prescribed 
        to give exporters time to apply for accreditation. If exporters 
        were given a fixed time after Assent within which to apply for accreditation, 
        then the amendments referred to in subclause 2(2) would commence as suggested 
        within the Drafting Instruction. The Committee, therefore, seeks the 
        Minister's advice as to why this commencement provision cannot be 
        made more certain by fixing a time for exporters to apply for accreditation. 
      
      Pending the Minister's advice, the Committee draws Senators' attention 
        to this provision, as it may be considered to inappropriately delegate 
        legislative powers in breach of principle 1(a)(iv) of the Committee's 
        terms of reference. 
      Relevant extract from the response from the Assistant Treasurer 
      
      As you will be aware, subclause 2(2) refers to the commencement date 
        for provisions relating to the export of various computer goods. The provisions 
        will commence on a date to be fixed by Proclamation, which can be at any 
        time after Royal Assent, with no time fixed for automatic commencement 
        or repeal. The Committee asked why it was not possible for the provisions 
        to have a fixed starting date. 
      The provisions which will commence on Proclamation will form part of 
        the recently enacted rules to combat sales tax evasion in the computer 
        industry. At the moment, the main features of the scheme - the system 
        of accreditation of reputable traders and authorisation of transactions 
        by the Commissioner - only apply to goods (personal computers and related 
        equipment) for use in Australia. 
      Since exports are exempt from sales tax, there is a fear that dishonest 
        traders may try to exploit this and the proposed provisions will extend 
        accreditation and authorisation to goods for export. It is known that 
        industry members are aware of the possibility of evading tax by abusing 
        the export exemption, and a slight increase in exports of the relevant 
        goods (not enough to warrant immediate action) has been noticed. 
      The Committee asked why the start date could not be more certain. 
      The Government's intention was that the start date should be as flexible 
        as possible. A flexible approach is necessary because of the entrenched 
        nature of the evasion and the ease and speed with which evaders will adopt 
        new methods of evasion. It is hoped that these amendments will act as 
        a deterrent, to discourage this kind of evasion from developing. The deterrent 
        value would be limited if a quick response to an emerging problem was 
        not possible. 
      Moreover, under these provisions, the potential compliance costs for 
        some exporters could be significant. If the provisions do operate effectively 
        as a deterrent to evasion, it may be possible to defer the start date 
        and associated costs indefinitely. Industry was consulted on the design 
        of the legislation and wanted provisions which targeted evasion but had 
        a limited impact on complying taxpayers and markets. Flexibility as to 
        the starting date of these new rules for exports is in line with the industry's 
        view on the design of the legislation. 
      Avoiding compliance costs in this case is specially desirable, because 
        it is intended that sales tax will end on 1 July 2000. Even if the legislation 
        had a fixed starting date, that date would not be until several months 
        after Royal Assent, because time would have to be allowed for public education 
        and the processing of applications. The starting date would then be no 
        more than 9 or 10 months before 1 July 2000, and, in the absence of proof 
        of abuse of the export exemption, it would not be cost effective for either 
        the industry or the Tax Office, to incur expenditure to prevent abuse. 
      
      It should be noted that there is a similarly open-ended commencement 
        date with respect to the retailer withholding regime, which is another 
        anti-evasion measure aimed at the computer industry. 
      I trust this information is of assistance to the Committee. 
      The Committee thanks the Assistant Treasurer for this response. 
       
      Therapeutic Goods Legislation Amendment Bill 1999
      Introduction 
      The Committee dealt with this bill in Alert Digest No. 3 of 1999, 
        in which it made various comments. The Parliamentary Secretary to the 
        Minister for Health and Aged Care has responded to those comments in a 
        letter dated 11 March 1999. A copy of the letter is attached to this report. 
        An extract from the Alert Digest and relevant parts of the Parliamentary 
        Secretary's response are discussed below. 
      The Committee notes that this bill was passed by the Senate on 11 March 
        1999, and so these comments are made for the information of Senators. 
      
      Extract from Alert Digest No. 3 of 1999 
      This bill was introduced into the Senate on 17 February 1999 by the Parliamentary 
        Secretary to the Minister for Communications, Information Technology and 
        the Arts. [Portfolio responsibility: Health and Aged Care] 
      The bill proposes to provide a new framework for the regulation and management 
        of complementary medicines by amending the Therapeutic Goods Act 1989 
        and the Therapeutic Goods Amendment Act 1997 to: 
      
        - amend key definitions to delineate between foods, complementary medicines 
          and other medicines such as over the counter and prescription medicines; 
        
 
        - establish the existing Complementary Medicines Evaluation Committee 
          as a statutory committee; 
 
        - enable sponsors of relatively low-risk products to market those products 
          without delay by enabling the efficient listing of the products on the 
          Register; 
 
        - ensure that all sponsors of listable goods must hold evidence to substantiate 
          therapeutic claims made in the market place; 
 
        - describe offences and penalties in relation to the publication of 
          certain advertisements in print media; and 
 
        - establish a statutory body, the National Drugs and Poisons Schedule 
          Committee. 
 
      
      Insufficient Parliamentary scrutiny
      Proposed new subsections 17(5) and (6)
      Item 10 of Schedule 1 to the bill proposes to insert a new subsection 
        17(5) in the Therapeutic Goods Act 1989. This subsection enables 
        the Minister, by publishing a Gazette notice, to add to the Register 
        of listed goods. Proposed new subsection 17(6) then provides for such 
        a notice to cease to have effect if the regulations are amended to include 
        those goods as either listed or registered goods. The Explanatory Memorandum 
        notes that these amendments should reduce delays in the marketing 
        of low-risk products by allowing these to be included in the Register 
        as listed goods, rather than registered goods. 
      However, it appears that one effect of proposed new subsection 17(5) 
        is that it may enable additions to the Register of listed goods to be 
        made without the need to include them in regulations. If so, this may 
        avoid Parliamentary scrutiny of such additions. The Committee, therefore, 
        seeks the Minister's advice on whether additions to the Register 
        for listed therapeutic goods under proposed subclause 17(5) will be subject 
        to parliamentary scrutiny. 
      Pending the Minister's advice, the Committee draws Senators' attention 
        to this provision, as it may be considered to insufficiently subject the 
        exercise of legislative power to parliamentary scrutiny in breach of principle 
        1(a)(v) of the Committee's terms of reference. 
      Extract from the response from the Parliamentary Secretary 
      
      The Government notes the Committees concern about insufficient Parliamentary 
        scrutiny of proposed subsection 17(5) and (6) of the Act. 
      The Parliament does not scrutinise the approval of any therapeutic goods 
        except new, low risk complementary medicines substances. This is an historical 
        anomoly. Approval for marketing of prescription medicines, over-the-counter 
        medicines and therapeutic devices is granted following consideration by 
        expert committees and is not subject to disallowable procedures. 
      These amendments will ensure timely market availability by gazettal of 
        low risk complementary medicines only after they have been evaluated by 
        the expert Complementary Medicines Evaluation Committee. 
      However, the TGA has undertaken to include the approved substances from 
        the Commonwealth Gazette notices in the Schedules to the Therapeutic 
        Goods Regulations every time the Regulations are updated (currently 
        4-5 times per annum). The scheduling of the gazettal notices will ensure 
        that there is an easily accessible, consolidated list of all gazettals 
        and will, at the same time, provide Parliament with an opportunity to 
        disallow any such schedule. 
      The Committee thanks the Parliamentary Secretary for this response. 
      Definitions and interpretation
      Proposed new Part 4A
      Item 12 of Schedule 1 to the bill proposes to insert a new Part 4A in 
        the Therapeutic Goods Act 1989. This new Part, which previously 
        resided in the Therapeutic Goods Regulations, deals with the advertising 
        of designated therapeutic goods. 
      As a general observation, the Committee notes that it is difficult to 
        understand the meaning of many of these provisions unless the reader has 
        a set of the Therapeutic Goods Regulations close at hand. 
      Secondly, proposed new section 42B, which contains relevant definitions, 
        defines mainstream media as any magazine or newspaper 
        for consumers containing a range of news, public interest items, advertorials, 
        advertisements or competitions. The Committee notes that, in some 
        respects, this definition is broad  possibly extending to magazines 
        containing a range of competitions  and yet does not refer to other 
        common means of advertising therapeutic goods, such as on the Internet. 
      
      The definition also refers to consumers with no further indication 
        of the products or services likely to be consumed. The definition also 
        includes the word advertorial, with no further explanation 
        of its meaning. While this term is apparently referred to in guidelines 
        for Advertising Therapeutic Goods to the Public, it is appropriate 
        that it should be more formally defined or referred to in the legislation 
        itself. 
      The Committee is aware of some previous correspondence on these issues 
        between the Senate Standing Committee on Regulations and Ordinances and 
        the Parliamentary Secretary to the Minister for Health and Family Services 
        as incorporated in the Senate Hansard on 13 May 1998. However, 
        the Committee seeks the Minister's advice on why these drafting 
        issues have not been clarified in introducing this legislation. 
      Extract from the response from the Parliamentary Secretary 
      
      The Government notes the Committee's concerns regarding definitions of 
        advertising. The definitions for mainstream media is taken 
        from the Therapeutic Goods Regulations and reflects exactly the 
        definition currently employed. 
      The term Mainstream is intended to encompass only mediums 
        of mass communication, for example newspapers or magazines for national 
        or regional general circulation. Mainstream is not intended 
        to apply to internal industry or organisation publications such as newsletters 
        or bulletins for practitioners or targeted membership audiences. 
      Assurances along these lines will be given in the Senate and the House 
        of Representatives Second Reading Speech. 
      I also note that the definition of advertorial' is now included 
        in the Macquarie Dictionary. 
      The Committee thanks the Parliamentary Secretary for this response, and 
        for the assurances to be given in the Second Reading Speech. The Committee 
        remains of the view that such clarifications are more appropriately a 
        matter for inclusion in the legislation itself, rather than in the material 
        accompanying the legislation. 
      Strict liability and other offences
      Proposed new sections 42C and 42D
      Proposed new section 42C deals with offences relating to the publication 
        of non-approved advertisements for therapeutic goods. Proposed subsection 
        42C(7) provides that these are strict liability offences. However, the 
        Explanatory Memorandum provides no guidance as to the need for imposing 
        strict liability in these circumstances. 
      Proposed subsection 42C(1) states that section 42C does not apply 
        to a publisher in respect of an advertisement received by the publisher 
        for publication or insertion in the ordinary course of business. 
        Publishers are instead subject to proposed new section 42D, which creates 
        an offence of `knowingly or recklessly publishing or inserting a non-approved 
        advertisement'. A publisher is defined as a person 
        whose business it is to publish or insert, or to arrange for the publication 
        or insertion of, advertisements in any publication. 
      Given that publishers are not subject to section 42C, it is not entirely 
        clear to whom that section is intended to apply. For example, an advertising 
        agency is, arguably, within the definition of a publisher (being in the 
        business of arranging for the publication of advertisements) and so outside 
        the scope of section 42C. Individuals may publish advertisements, but 
        these are likely to be classified advertisements only. 
      The Committee therefore, seeks the Minister's advice on why proposed 
        section 42C creates offences of strict liability, and on those persons 
        who are likely to be subject to those offences. 
      Pending the Minister's advice, the Committee draws Senators' attention 
        to this provision, as it may be considered to trespass unduly on personal 
        rights and liberties in breach of principle 1(a)(i) of the Committee's 
        terms of reference. 
      Extract from the response from the Parliamentary Secretary 
      
      The Government also notes your concerns regarding the strict liability 
        nature of penalty provisions for advertising breaches. 
      Under the Therapeutic Goods Regulations, advertisements placed in mainstream 
        print media are required to be cleared by the Secretary before they may 
        be published. The Secretary has, under the terms of the Regulations, delegated 
        this function to the Proprietary Medicines Association of Australia (PMAA) 
        and the Complementary Healthcare Council of Australia (CHC). The offences 
        and penalties relating to advertisements in mainstream print media that 
        are required to be pre-cleared by the CHC or the PMAA, have been moved 
        from the Regulations into the Therapeutic Goods Act 1989. 
      The offence provisions in the new Section 42C are identical to those 
        that are currently in the Therapeutic Goods Regulations at regulation 
        5D and 5E. 
      The inclusion of these offence and penalty provisions in the Act will 
        enhance the pre-clearance scheme. Under the existing Regulations the maximum 
        penalty that could be imposed, in accordance with Commonwealth government 
        legal policy as reflected in section 63 of the Act, is 10 penalty units 
        ($1,000). While this penalty was recognised as inappropriate at the time, 
        it was considered more important that the offences be included in order 
        to lend some support to the pre-clearance decision making of the (then) 
        Nutritional Foods Association of Australia (NFAA) and PMAA. 
      The offences and penalty provisions have been moved from the Regulations 
        into the Act, and penalties have been increased for two key reasons: 
      (a) to lend greater support to industry decisions and consumer confidence, 
        though the CHC and PMAA clearance process. Moving the offences and penalties 
        to the Act reflects the importance of the provisions and provides greater 
        recognition to the role of the CHC and PMAA in assessing the appropriateness 
        of advertisements for publication in mainstream media; and 
      (b) to achieve a degree of consistency with similar provisions in the 
        Broadcasting Services Act 1992. 
      The Broadcasting Services Act (BSA) describes the offences and 
        penalties in relation to the broadcast of advertisements in electronic 
        media under a similar pre-clearance scheme. A similar offence for publishing 
        advertisements that are in breach of the Therapeutic Goods Advertising 
        Code under the Broadcasting Services Act 1992 attracts a penalty 
        of $200,000. By contrast, the maximum penalty available under the Therapeutic 
        Goods Regulations is $1,100. 
      Penalties should as far as possible be consistent across Commonwealth 
        legislation (like penalties for like offences). While the 
        proposed new penalties for inclusion in the amendment Bill are still significantly 
        less than those in the Broadcasting Services Act, they fit within 
        the penalty levels imposed under the Act and the Attorney General's Department 
        have advised that, whilst still low, they are acceptable. 
      The Attorney General's Department has advised that, the offences should 
        attract strict liability in view of the fact that the penalties are significantly 
        lower than the penalties currently applying under the Broadcasting 
        Services Act for comparable offences. This also properly reflects 
        the serious nature of a breach of the Therapeutic Goods Advertising 
        Code applying to medicines, which in part is designed to discourage 
        self diagnosis and self-treatment of serious and major medical conditions. 
      
      I hope that these explanations assist the Committee and trust that these 
        amendments, introduced mainly at the behest of industry and consumer groups, 
        will see smooth passage through Parliament and implementation. 
      The Committee thanks the Parliamentary Secretary for this response. While 
        the transposition of these provisions from the regulations to the bill 
        is clearly a worthwhile measure, this seems to the Committee to have been 
        an opportunity lost to clarify some of the drafting and other issues. 
        For example, those persons or organisations to whom section 42C is intended 
        to apply remain unclear. 
      For this reason, the Committee continues to draw Senators' attention 
        to this provision, as it may be considered to trespass unduly on personal 
        rights and liberties in breach of principle 1(a)(i) of the Committee's 
        terms of reference 
      Barney Cooney 
      Chairman