Bills Digest No. 42, 2013–14              11 February 2014

Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013

Leah Ferris, Social Policy Section

Kerry Knowler, Law and Bills Digest Section

Date introduced: 12 December 2013

House:  House of Representatives

Portfolio: Health

Commencement: On Royal Assent

Links: The links to the Bill, its Explanatory Memorandum and second reading speech can be found on the Bill’s home page, or through http://www.aph.gov.au/Parliamentary_Business/Bills_Legislation

When Bills have been passed and have received Royal Assent, they become Acts, which can be found at the ComLaw website at http://www.comlaw.gov.au/.

History of the Bill

An earlier version of the Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013 (the first Bill) was introduced by the former Australian Labor Party (Labor) Government into the House of Representatives on 20 March 2013.[1] It was debated in that chamber and the third reading was agreed to on 18 June 2013. The first Bill was introduced into the Senate on 19 June 2013 but lapsed at the end of the 43rd Parliament.

The current Bill is in similar, but not identical, terms to the first Bill.

Purpose of the Bill

The Therapeutic Goods Amendment (2013 Measures No.1) Bill 2013 (the current Bill) is intended to strengthen regulation and improve the operation of the Therapeutic Goods Act 1989 (TG Act).[2]

The Bill introduces:

•       two new measures intended to reinforce the objects of the Therapeutic Goods Act concerning the quality, safety, efficacy and timely availability of therapeutic goods. They are:

–      the ability to exclude certain goods from the definition of ‘therapeutic goods’ and

–      a clarification of the power to remove products from the Register of Therapeutic Goods that do not satisfy the definition of therapeutic good

•       a new criminal offence and associated civil penalty provision, for providing a false or misleading statement in relation to a request for a variation to an entry on the Register of Therapeutic Goods

•       a new ground for suspending or cancelling goods from the Register of Therapeutic Goods

•       clearer provisions relating to the Secretary’s power to approve product information and

•       other technical amendments.

Structure of the Bill

This Bill comprises 16 schedules amending the TG Act:

•       Schedule 1: amendments operate so that complying with advertising requirement in the TG Act includes complying with the Therapeutic Goods Advertising Code

•       Schedule 2: relates to the powers of the Secretary to obtain information and widens the offence provisions which operate when the Secretary has given a person written notice to provide information or produce documents

•       Schedule 3: empowers the Minister to determine that certain goods are not therapeutic goods and so are excluded goods

•       Schedule 4: amends section 42DL of the TG Act to ensure that a person does not commit an offence relating to use of restricted representations or prohibited representations if that use has been approved by the Secretary

•       Schedule 5: clarifies the requirement for the Secretary to decide to either register or not register goods following the evaluation process

•       Schedule 6: provides greater flexibility as to the timeframe within which changes to conditions of registration, listing or inclusion on the Register take effect

•       Schedule 7: provides for the cancellation of registration or listing of goods based on presentation

•       Schedule 8: extends the right to merits review to a decision to consent to the import, supply or export of goods subject to conditions

•       Schedule 9: makes it clear that where the Minister revokes an initial decision of the Secretary and substitutes a new decision, that decision is treated as a decision of the Secretary

•       Schedule 10: expands the meaning of a kit

•       Schedule 11: creates criminal offences and a corresponding civil penalty provision in relation to false and misleading statements made in connection with a variation request

•       Schedule 12: provides a minimum notice period for the cancellation of registration or listing

•       Schedule 13: allows for publication of decisions in the Gazette or on the Department’s website

•       Schedule 14: allows a longer period of time for the Secretary to select applications for auditing and to request information from the applicant that is relevant to the audit

•       Schedule 15: provides for cancellation of a registration or listing of a product where a sponsor has failed to comply with requirements to provide information and

•       Schedule 16: consists of other amendments.

Background

Therapeutic Goods Act 1989

The TG Act sets out the legal requirements for the import, export, manufacture and supply of therapeutic goods in Australia.[3] It details the requirements for listing, registering or including medicines, medical devices and biological products on the Australian Register of Therapeutic Goods (the Register), as well as many other aspects of the law including advertising, labelling, and product appearance.[4]

Therapeutic Goods Administration

The Therapeutic Goods Administration (TGA) is a division of the Australian Government Department of Health, and is the regulatory authority responsible for administering the TG Act.[5]

The purpose of the TGA is ‘to protect public health and safety by regulating therapeutic goods that are supplied, either imported or manufactured, or exported from Australia’ while ensuring that ‘the Australian community has access, within a reasonable timeframe, to new therapeutic goods.’[6]

Therapeutic goods are defined under subsection 3(1) of the TG Act. They include medicines, medical devices, and human blood, blood products, tissues and other biologicals.[7] All goods that fall within this definition are regulated under the TG Act and are required to be included in the Register.[8]

TGA reforms

The TGA has been the subject of several major reviews including:

•       the review to improve transparency of the TGA (report released July 2011)[9]

•       the Working Group on Promotion of Therapeutic Products (report released March 2011)[10]

•       public consultations on the regulatory framework for advertising therapeutic goods (held November 2010)[11]

•       the Auditor-General’s report on Therapeutic Goods Regulation: Complementary Medicines (report released August 2011)[12]

•       public consultations on the medical devices regulatory framework (held November 2010)[13] and

•       the Australian Government Health Technology Assessment Review (report released December 2009).[14]

In response to these reviews the Government released TGA reforms: a blueprint for TGA’s future, (the Blueprint) in December 2011.[15] Subsequently, on 16 July 2012 a detailed plan entitled Delivering reforms—Implementation plan for TGA Reforms: a blueprint for TGA’s future was released publicly.[16]

Importantly the current Bill is not related to plans to implement those recommended reforms.

Committee consideration

Senate Selection of Bills Committee

At its meeting of 11 December 2013, the Senate Selection of Bills Committee determined that the current Bill would not be referred to Committee for inquiry and report.[17]

Senate Community Affairs Legislation Committee

However, the first Bill was referred to the Senate Community Affairs Legislation Committee (the Community Affairs Committee) for inquiry and report.[18] The Community Affairs Committee made the following recommendations in relation to the first Bill:

•       the Senate consider any findings or recommendations made by the Scrutiny of Bills Committee in respect of proposed section 7AA (inserted by item 2 of Schedule 3 of the Bill)[19]

•       the Senate consider any findings or recommendations made by the Parliamentary Joint Committee on Human Rights in respect of amendment of section 60 of the TG Act to remove the merits review of certain decisions relating to product information (inserted by item 10 of Schedule 5 of the first Bill but omitted from this Bill)[20]

•       the Bill be amended to align the publication options in proposed section 9F (inserted by item 5 of Schedule 3 of the Bill) with other existing provisions in the TG Act and[21]

•       subject to the other recommendations, that the [first] Bill be passed.[22]

Further discussion about the Community Affairs Committee’s views is included under the relevant Schedule headings below.

Senate Standing Committee for the Scrutiny of Bills

Comments on the first Bill by the Scrutiny of Bills Committee, which are alluded to above, are contained in Alert Digest No. 5 of 2013, released on the 15 May 2013.[23]

The views of the Scrutiny of Bills Committee are included under the relevant Schedule headings below.

Parliamentary Joint Committee on Human Rights

The Parliamentary Joint Committee on Human Rights (Human Rights Committee) commented on the first Bill in its Sixth Report of 2013.[24] The Human Rights Committee noted that the Bill engages the following human rights:

•       the right to health under article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR)[25] and

•       the right to a fair hearing, the right to be presumed innocent and the entitlement to minimum criminal guarantees under Articles 14(1) and 14(2) of the International Covenant on Civil and Political Rights (ICCPR).[26]

The Human Rights Committee considered that the [first] bill generally ‘promotes enjoyment of the right to health’.[27] Its additional concerns about the absence of merits review are not relevant to this Bill as those provisions have been omitted.

The comments of the Human Rights Committee are included under the relevant Schedule headings below.[28]

Statement of Compatibility with Human Rights

As required under Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011 (Cth), the Government has assessed the Bill’s compatibility with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of that Act.[29] The Government considers that the Bill is compatible.

Policy position of non-government parties/independents

At the time of writing this Bills Digest there were no published views of non-government parties or independents on this Bill. As the current Bill is similar in its terms to the first Bill, the measures are expected to have broad support from Members and Senators.

Position of major interest groups

A number of key industry stakeholders commented on the proposed amendments to the TG Act included in the first Bill. Overall the 11 submissions to the Community Affairs Committee inquiry into the first Bill are supportive of the proposed reforms.[30] In particular, the NSW Ministry of Health, the Australian Orthopaedic Association, the Australian Commission on Safety and Quality in Health Care and the Northern Territory Department of Health fully supported the first Bill.

However, a number of submitters expressed concern that the first Bill did not put into place the Blueprint recommendations. (This also applies to the current Bill.) For example, the Complementary Healthcare Council of Australia (CHCA) is of the view that many of the proposed amendments are premature (in light of the outstanding reforms to the complementary medicine provisions and the fact that the Blueprint recommendations are not yet implemented) and disproportionately apply to (what it terms) low-risk products.[31]

The Australian Dental Industry Association (ADIA) also took this view:

This document [the Blueprint] constitutes a response to several major reviews of therapeutic goods regulation that were undertaken in 2010 and 2011 and addresses matters from product regulatory standards, advertising, promotion and transparency. It would have been possible, and indeed desirable, to deal with the proposals before the parliament as part of, rather than separate from, that series of reforms.[32]

The comments of other submitters to the Community Affairs Committee are included under the relevant Schedule headings below.

Financial implications

According to the Explanatory Memorandum the Bill will have a ‘nil financial impact on the Commonwealth’ as the TGA, which administers the TG Act, ‘operates on a cost recovery basis’.[33]

Key issues and provisions

Schedule 1—advertising

The primary purpose of Schedule 1 of the Bill is to amend the TG Act to clarify that a reference to advertising requirements includes a reference to the Therapeutic Goods Advertising Code (the Code).[34]

Under the TG Act:

•       section 25 relates to the evaluation and registration of therapeutic goods. Under that section the Secretary must evaluate goods in accordance with factors outlined under subsection 25(1), including, amongst other things whether the goods conform to any requirements relating to advertising applicable under Part 5-1 of the TG Act or under the regulations

•       section 26 relates to the listing of therapeutic goods on the Register. Under that section the Secretary must not refuse to list the goods unless the Secretary is satisfied that any of the factors outlined under subsection 26(1) of the TG Act apply, including, amongst other things that the goods do not conform to a requirement relating to advertising applicable under Part 5-1 of the TG Act or under the regulations

•       section 26A applies to applications for the listing of certain medicines. An applicant must certify each of the matters detailed in subsection 26A(2) of the TG Act including, amongst other things whether the goods conform to every requirement relating to advertising applicable under Part 5-1 of the TG Act or under the regulations

•       section 30 empowers the Secretary to cancel the registration or listing of goods on the grounds set out in subsection 30(1). In addition, the Secretary may cancel the listing of a medicine (listed under section 26A of the TG Act) on the grounds set out in subsection 30(1A) of the TG Act. Those grounds include, amongst other things, that the goods do not conform to a requirement relating to advertising applicable under Part 5-1 of the TG Act or under the regulations.

The amendments in items 1–7 and 9–10 apply to each of those sections to include a requirement that the applicable provisions of the Code are complied with.

Items 11–22 of Schedule 1 of the Bill achieve the same purpose—that is to explicitly require compliance with the Code.

Comments

Division 2 of Part 4-6 of the TG Act (sections 41GK to 41GQ) sets out the circumstances in which medical devices may be removed from the Register. Section 41GL sets out when the Secretary may immediately cancel the entry of a medical device in the Register. One ground on which the Secretary may do so is when there is a breach of the advertising requirements, which is significantly misleading (paragraph 41GL(h)). Item 21 of Schedule 1 amends paragraph 41GL(h), to clarify that the advertising requirements referred to include the Code. Section 41GN of the TG Act sets out circumstances in which the Secretary may cancel the entry of a medical device in the Register, after giving the relevant person an opportunity to make submissions on the proposed cancellation (that is, in contrast to section 41GL, cancellation is not immediate). The previous Bill proposed an amendment to subsection 41GN(1) to make non-compliance with advertising requirements, including the Code, a ground for removing a device from the Register.[35] This amendment is not included in the current Bill.

Schedule 2—obtaining information

Section 31 of the TP Act authorises the Secretary to require, by notice in writing, that certain persons provide information or documents. Those persons are:

•       an applicant for the registration of therapeutic goods

•       a person in relation to whom therapeutic goods are registered or

•       a person in relation to whom therapeutic goods were registered at any time during the previous five years.[36]

Existing subsection 30(1C) empowers the Secretary to give notice of an intention to cancel the listing of a medicine which is listed under section 26A of the TP Act if the Secretary has given the person a notice to produce information or documents under section 31 for the purpose of ascertaining whether the medicine should have been listed and the person does not comply with the notice within the relevant time.

The amendments in Schedule 2 do two things. First, item 1 of Schedule 2 of the Bill amends paragraph 30(1C)(b) of the TG Act by removing the reference to the purpose of the notice as being ‘whether the medicine should have been listed’ and replacing it with a reference to the notice being given to ascertain the correctness of certifications made by the person under subsections 26A(2) and (2A) of the TG Act. As a result of the amendment any matters that are certified by a sponsor before entering their goods in the Register can be considered by the Secretary and if incorrect can be grounds for cancellation.[37]

Second, items 3–10 of Schedule 2 of the Bill contain amendments to the offence and civil penalty provisions at subsections 31(5A), (5B) and (6), and section 31AAA of the TG Act which relate to the provision of information or documents, in response to a notice given under section 31 of the TP Act, that is false or misleading in any material particular. The effect of the amendments is to widen the offence provisions under subsections 31(5A), 5(B) and 6, and section 31AAA of the TG Act to include ‘any person’ to whom the Secretary can issue a notice under section 31 and not just a person ‘to whom a medicine is listed’ under section 26A of the TG Act. Items 12 and 15 of the Bill amend the relevant offence provisions for biological[38] and medical devices (subsection 32JB(1) and 41JB(3)) to exclude the offence from applying to those who have only applied to have biologicals or medical devices in the Register (as they already have a strong incentive to respond to requests for information, less their application be denied).[39]

Comments

The only significant change from the previous Bill is the removal of amendments which were aimed at expanding what information/documents the Secretary could request from the sponsor of a listed medicine, biological or medical device.[40] While it is not clear why these were removed, it is likely that the Government decided that the amendments contained in items 3-10 were sufficient.

Schedule 3—goods that are not therapeutic goods

Excluded goods

Paragraphs (a) and (b) of the definition of therapeutic goods in subsection 3(1) of the TG Act specify those goods which are, for the purpose of the TG Act included in that term. Paragraphs (c)–(f) of the definition specify those goods which are not included in the term. Item 1 of Schedule 3 of the Bill inserts paragraphs (g) and (h) into the definition to nominate two new types of goods which are not therapeutic goods for the purposes of the TG Act. Those paragraphs refer to goods covered by a determination under subsection 7AA(1) or 7AA(2) respectively.

Item 2 of Schedule 3 inserts proposed section 7AA into the TG Act which provides that the Minister may determine that specified goods (other than goods declared to be therapeutic goods under an order in force under section 7 of the TG Act),[41] or goods (other than goods declared to be therapeutic goods under an order in force under section 7 of the TG Act) when used, advertised, or presented for supply in a way specified in the determination[42] are excluded goods for the purposes of the TG Act. The notes following proposed subsections 7AA(1) and (2) make it clear that the Minister’s determination may cover a class of goods.

The Minister’s determination under proposed section 7AA of the TG Act is a disallowable legislative instrument.[43]

In making the determination, the Minister must have regard to the matters set out in proposed paragraphs 7AA(3)(a)–(c) and any other matter which he or she considers is relevant.[44]

According to the Department of Health and Ageing the differences between proposed section 7AA and existing section 7 of the TG Act are as follow:

… section 7 allows the Secretary to confirm by way of determination that goods are not therapeutic goods. It is predicated on the Secretary being satisfied that the goods are not in fact therapeutic goods. If there is insufficient material on which she could come to that view then no determination can be made. Section 7AA allows the Minister to declare that products are not therapeutic goods whether or not they come within the definition of therapeutic goods. The kinds of products in relation to which the Minister might make a determination would not be ones that in order to be supplied safely in Australia, require regulation of the kind found in the TG Act.[45]

The rationale for proposed section 7AA is ‘to address the increasingly common practice for therapeutic claims to be made for a range of goods (perhaps to make them more appealing to health conscious consumers), even if they have no or little bearing on actually preventing, or alleviating any illness or injury, or any other health-related impact’.[46] For example:

… goods for which therapeutic claims have been made include mattresses which contain bacterial spores designed to reduce the effects of dust mites and ‘power band’ bracelets, where it was claimed that the use of the latter would boost a wearer’s balance, strength and flexibility.[47]

Where there is uncertainty, it will also allow the Minister to respond flexibly on a case by case basis to clarify whether a particular product falls within the definition.[48]

This is important given the broad definition of therapeutic goods and the strict regulatory requirements, costs and civil and criminal penalties (associated with non-compliance with the TG Act) that apply in relation to goods which fall within the definition.

The new power is also intended to provide greater certainty and clarity for suppliers of products in relation to whether particular products are regulated under the Act. This is important because of the significant penalties for non-compliance with the Act. For instance, the Act provides significant criminal and civil penalties in the event that goods coming within the definition of ‘therapeutic goods’ are imported, exported or supplied in Australia are not included in the Register or not otherwise exempt from inclusion.[49]

Industry concerns

Some industry concerns were expressed in relation to the drafting of the first Bill. For example, Medicines Australia (MA) was concerned that there is no requirement for an affected party to be consulted prior to the Minister determining that a good is an excluded good under proposed section 7AA. Although a determination made by the Minister under this proposed provision is subject to disallowance, MA does not believe that this amounts to ‘meaningful industry consultation’. Accordingly, MA would like to see ‘industry consultation prior to determinations that affect members’ interests.[50]

The Australian Medical Association (AMA) is concerned that the increased focus on the regulation of therapeutic goods may mean that consumers are ‘less protected from false or misleading claims about the therapeutic benefit of products that will be expressly excluded from the regulatory scheme … ‘.[51] That being the case, the AMA considered that the Bill should be amended to clarify that ‘excluded’ therapeutic goods are subject to the consumer protection provisions of the Competition and Consumer Act 2010[52] which deals with false and misleading claims.[53]

Committee concerns

Scrutiny of Bills Committee

Similarly, the Scrutiny of Bills Committee raised the issue of the broad discretionary power granted to the Minister by proposed section 7AA as it was drafted in the first Bill and questioned whether it amounted to an inappropriate delegation of legislative power.[54] The Scrutiny of Bills Committee expressed its concern that it was not clear what sort of public policy reasons would be considered appropriate for excluding specified goods from the requirements of the TG Act. In addition, the Committee considered the proposed provisions (under items 1 and 2 of Schedule 3 of the first Bill) may ‘be unduly dependent upon insufficiently defined administrative powers’ and ‘may also be considered to delegate legislative powers inappropriately’. Therefore, the Committee sought:

… the Minister’s advice as to whether consideration has been given as to specifying the purposes for which this power may be exercised or to other ways to confine this power (which amounts to a broad discretion to exclude the operation of the Act in relation to particular goods).[55]

Community Affairs Committee

In its report on the first Bill, the Community Affairs Committee also considered the issue of the broadened ‘scope of this regulation-making power’ and outlined some possible options for defining it, or guiding its application.[56] A discussion of each of these options is outlined on pages 22-23 of the Committee report.

Response

The current Bill appears to address the Committee concerns with the inclusion of proposed subsections 7AA(3) and (4). These additional provisions set out matters to which the Minister must have regard prior to making his, or her, decision.

Removal of entries from the Register

Item 5 of Schedule 3 of the Bill inserts proposed section 9F into the TG Act. Proposed subsection 9F(2) allows the Secretary to remove an entry of goods from the Register, by written notice[57] given to the person in relation to whom the goods are entered on the Register if the Secretary is satisfied that the goods are not therapeutic goods: proposed paragraph 9F(1)(b).

Before removing the entry the Secretary must take all of the following steps:

•       inform the person in writing of the proposed removal and set out the reasons for doing it: proposed paragraph 9F(3)(a)

•       invite the person to make submissions within the specified period of not less than 20 working days from notification: proposed paragraph 9F(3)(b) and

•       have regard to any submissions made: proposed subsection 9F(4).

The removal of an entry has effect on the day specified in the notice, which must not be earlier than 20 working days after the notice is given to the person: proposed subsection 9F(6). The particulars of the removal must be published in the Gazette or on the Department’s website: proposed subsection 9F(7). The first Bill provided only for publication on the Department’s website. The updated drafting of proposed subsection 9F(7) in this Bill is a response to one of the recommendations of the Community Affairs Committee.[58]

Proposed section 9F is designed to address situations where ‘non therapeutic goods’ have been included in the Register. For example, some products, such as a low-risk kind of medical device may be included in the Register without prior approval by the TGA[59], or there may be situations in which a product may have been a ‘therapeutic good’ at the time of entry on the Register, but has subsequently changed such as it ceases to be covered by that definition.

Item 7 of Schedule 3 of the Bill ensures that decisions made by the Secretary under section 9F of the TG Act may be reviewed by the Minister and if not resolved may be reviewed by the Administrative Appeals Tribunal (AAT).

Comment

This amendment has been included to address any argument that ‘the current cancellation powers under the TG Act only apply to ‘therapeutic goods’ and so cannot be used to remove goods in the Register that are not, or have ceased to be, therapeutic goods’.[60]

The power to remove products from the Register is quite separate from the existing powers under the Act to cancel goods from the Register about which there are safety, quality or efficacy issues. Such goods do not stop being therapeutic goods and remain regulated under the Act as therapeutic goods.[61]

Schedule 4

The amendments in Schedule 4 of the Bill remove inconsistencies relating to advertising offences in Division 3A of Part 5-1 of the TG Act.

Section 42DD of the TG Act defines a restricted representation about therapeutic goods as a representation in an advertisement about therapeutic goods that refers to a form of a disease, condition, ailment or defect identified in a part of the Therapeutic Goods Advertising Code as a serious form of a disease, condition, ailment or defect.

Under subsection 42DL(1) of the TG Act it is an offence of strict liability for a person to publish or broadcast an advertisement about therapeutic goods that contains a restricted representation about those goods if, amongst other things, the use of that restricted representation has not been permitted under subsection 42DK(1).[62] Subsection 42DK(1) gives the Secretary the power to permit the use of a restricted representation either on the label of a therapeutic good or in the information contained in its packaging.

Section 42DJ of the TG Act defines a prohibited representation about therapeutic goods as being one of a kind specified in the regulations. As presently drafted section 42DL of the TG Act does not reflect the fact that the Secretary may permit the use of a prohibited representation, under subsection 42DK(2). Item 1 of Schedule 4 of the Bill amends paragraph 42DL(1)(a) so that it will do so. In addition, the effect of the insertion of proposed paragraph 42DL(2)(aa) by item 2 of Schedule 4 is to clarify that the offence of strict liability arising from paragraph 42DL(1)(a) only applies where the prohibited representation has not been permitted.

Comments

There are no significant changes from the previous Bill.

Schedule 5

The items in Schedule 5 of the Bill amend various provisions of Part 3-2 of the TG Act which deals with the registration and listing of therapeutic goods.

If an application is made for the registration of therapeutic goods under section 23 of the TG Act the Secretary must evaluate the goods with regard to the matters set out under section 25 of the TG Act.[63] Subsections 25(3)–(5) currently prescribe the steps which must be undertaken by the Secretary once the evaluation of the goods is completed. However, the TG Act does not explicitly require the Secretary to decide whether or not to register the goods.[64] Item 4 of Schedule 5 of the Bill repeals and replaces subsections 25(3)-(5) of the TG Act with proposed subsection 25(3) to address that defect. New subsection 25(3) requires the Secretary to either decide to register the goods or to not register the goods once an evaluation of the goods has been completed.

Item 5 of Schedule 5 of the Bill repeals existing subsection 25AA(1) and inserts proposed subsections 25AA(1) and (1A) into the TG Act. Those subsections require the Secretary to approve product information in relation to therapeutic goods (if the Secretary has decided to register the goods) and those goods are a restricted medicine[65]or a medicine (other than restricted medicine) in relation to which the applicant has been given a formal notice by the Secretary to provide product information. Product information must not be approved if it does not reflect the basis as that on which the goods were approved.[66]

Subsection 25AA(4) of the TG Act sets out when product information can be varied. This can occur when the Secretary varies the entry in the Register for the medicine or where there is a change in the conditions to which the registration of the medicine is subject, and the Secretary considers it appropriate to alter the product information to reflect these changes. Proposed subsection 25AA(4A) provides that where the Secretary does vary product information the variation must reflect the basis on which the Secretary decided to vary the entry on the Register (proposed paragraph 25AA(4A)(a)) or to change the conditions to which the registration of the medicine is subject (proposed paragraph 25AA(4A)(b)).

Item 9 of Schedule 5 of the Bill inserts proposed sections 25AB and 25AC into the TG Act. Proposed section 25AB applies if an application is made in accordance with section 23 of the TG Act for the registration of therapeutic goods that are therapeutic devices and the Secretary decides under proposed subsection 25(3) to register the goods. In that case the Secretary must notify the applicant of the decision within 28 days of making the decision, include the relevant goods on the Register and give the applicant a certificate of registration: proposed paragraphs 25AB(1)(d)–(f).

For therapeutic goods that are not therapeutic devices,[67] additional requirements are prescribed that must be notified to the applicant and that must be complied with before the goods are included in the Register: proposed subsections 25(3) and (4).

Proposed section 25AC provides that where the Secretary has elected not to register the goods, the applicant must be notified in writing within 28 days of the decision having been made.

Comments

The first Bill contained provisions which would have removed the right to merits review of decisions relating to the approval of product information. Those amendments are not contained in this Bill.

Schedule 6

The amendments in Schedule 6 of the Bill amend the timeframes within which changes to conditions imposed on therapeutic goods in the Register, as well as changes to conditions of manufacturing licences and assessment certificates, are able to come into effect. Currently, these changes commence on a day specified in the written notice given by the Secretary to the relevant person (that is, the sponsor, certificate or licence holder), which must not be earlier than either 28 days (for sections 28, 32EE and 40) or 20 days (for sections 41EL and 41FP), after the notice is given to the person.

The effect of items 1-7 is to allow the relevant person to agree to the changes starting on a day earlier than 28 days after the giving of the notice (but not earlier than the giving of the notice), in relation to:

•       changes to conditions of registration or listing of goods already in the Register: proposed paragraphs 28(4)(aa) and (ab) and proposed subsection 28(4A)

•       changes to conditions of registration or listing of a biological already in the Register: proposed paragraphs 32EE(3)(aa) and (ab) and proposed subsection 32EE(3A) and the

•       the imposition or variation of a manufacturing licence condition: repeal and replace paragraph 40(3)(b) and insert proposed subsection 40(3A).

Items 8-13 of Schedule 6 make equivalent amendments, allowing the relevant person to agree to the changes starting on a day earlier than 20 days after the giving of the notice (but not earlier than the giving of the notice), in relation to:

•       changes to conditions of a conformity assessment certificate after it has been issued to manufacturers of medical devices: proposed paragraphs 41EL(2)(aa) and (ab) and proposed subsection 41EL(3) and

•       the imposition or variation of conditions imposed on a medical device in the Register: proposed paragraphs 41FP(2)(aa) and (ab) and proposed subsection 41FP(3).

This will allow the Secretary to respond flexibly to requests to change conditions.[68]

Comments

There are no significant changes from the previous Bill.

Schedule 7

Presentation, in relation to therapeutic goods, means the way in which the goods are presented for supply, and includes matters relating to the name of the goods, the labelling and packaging of the goods and any advertising or other informational material associated with the goods.[69] For a therapeutic good to be registered or listed in the Register it must, amongst other things, satisfy the criterion of presentation.[70]

Section 30 of the TG Act sets out the grounds upon which the Secretary may, by notice in writing[71] cancel the registration or listing of therapeutic goods. Currently there is no reference to the presentation of goods.[72]

Item 1 of Schedule 7 of the Bill inserts proposed paragraph 30(2)(aa) into the TG Act to provide a new power allowing the Secretary to cancel the registration or listing of goods if it appears to the Secretary that the presentation of:

•       registered goods—is not acceptable or

•       listed goods—is unacceptable.[73]

Medicines are classified as either registered or listed, depending on their ingredients and what they claim to do.[74] Higher risk medicines must be registered on the Australian Register of Therapeutic Goods (ARTG), which involves individually evaluating the quality, safety and effectiveness of the product, while lower risk medicines are listed and assessed by the TGA for quality and safety but not efficacy.[75]

According to the Explanatory Memorandum:

As both cases suggest, there can be significant safety concerns associated with the presentation of therapeutic goods not being acceptable, or being unacceptable, and it is important that the Act contain an appropriate cancellation power to reinforce the fact that this issue is a factor to be taken into account in determining whether therapeutic goods should be included, and once included, remain, in the Register.[76]

The Community Affairs Committee report noted in relation to the first Bill (and relevant to this Bill) that:

The precise standard of presentation that a good must meet in order to be placed on the Register depends on the category into which it falls. For registered goods, the presentation must be 'acceptable'. For the category of listed goods, for those listed under section 26 of the Act, the secretary cannot refuse listing unless the presentation is 'unacceptable'. The process is slightly different for medicines being listed under section 26A of the Act, in which cases the presentation of the medicine must be 'not unacceptable'.[77]

Subsection 3(5) of the TG Act prescribes when the presentation of goods is unacceptable and outlines examples of such circumstances under paragraphs 3(5)(a)-(e) as well as under Regulation 3A of the Therapeutic Goods Regulations 1990.[78] However, no such definition or examples are provided as guidance about what presentation of goods is acceptable.

Instead, the Explanatory Memorandum describes the circumstances where the presentation of goods is not acceptable:

… can encompass a range of factors that might go beyond the scope of the definition of ‘unacceptable presentation in subsection 3(5) of the Act. For example, the presentation of registered goods may cover matters such as consumer medicine information for the goods.[79]

Industry concerns

MA is concerned that the proposed new powers of the Secretary are not clear or predictable as:

•       there is no statutory definition of the term ‘not acceptable’ in relation to registered goods and

•       it is unclear whether the outcomes of the current TGA Packaging and Labelling Review could affect this interpretation.[80]

The Generic Medicines Industry Association (GMIA) is also concerned about the possible impact of the TGA’s Labelling and Packaging Review (once complete) on this proposed provision.

…members of GMiA are concerned about the implications of this Bill on the cancellation of medicines from the Australian Register of Therapeutic Goods (ARTG) based on “presentation” and the follow on consequences that may follow as a result of the current Therapeutic Goods Administration (TGA) review of labelling and packaging.[81]

Accordingly, GMIA recommends that more consideration be given to the possible outcomes of the Review and that in the meantime, current goods in the Register are protected from the changes in this Bill.[82]

In response to those concerns, the Department provided the following advice to the Community Affairs Committee about the use of the term ‘not acceptable’:

This reference was not intended to imply that the matters set out in subsection 3(5) of the TG Act would not be relevant in considering whether the presentation of registered goods may be 'not acceptable'. Rather, this reference sets out that such matters would (where applicable) be relevant in understanding the meaning of 'not acceptable', but that there could also be other factors or circumstances (in addition to those in subsection 3(5)) in which the presentation of registered goods may not be acceptable. Such additional circumstances may relate to matters particular to registered medicines, such as the presentation of product information or consumer medicine information.[83]

As to those concerns about the relationship between the amendments relating to presentation and the review currently underway, the Department states that the amendments:

… do not relate to, or pre-empt the outcomes of the TGA's Labelling and Packaging Review…the proposed new power would not be necessary for or related to, the enforcing of any new labelling and packaging requirements as these are expected to be implemented using a different mechanism…[84]

Committee view

The Community Affairs Committee formed the view that:

The committee is supportive of the policy objective reflected in the proposed amendment. The committee understands the concern of some submitters, and found the provisions of the existing legislation and the proposed amendment difficult to navigate. There are several overlapping reasons that make the operation of these sections difficult to interpret:

• The construction of section 25 in the positive, but section 26 in the negative;

• The fact that 'acceptable' and 'unacceptable' do not mean the exact opposite of each other; and

• The fact that 'unacceptable' and 'not acceptable' do not have the same meaning.

On balance, the committee is satisfied that the amendments will achieve an important policy objective. The committee suggests that, in the course of the broader review of the Act, the government consider simplification of the legislation, by changes such as framing sections 25 and 26 in the same form, or considering removal of the distinction between unacceptable and not acceptable.[85]

Schedule 8

As stated in the Explanatory Memorandum:

This Schedule contains amendments to the Act to provide a right of merits review where, under subsection 15(1) of the Act, the Secretary imposes conditions on the granting of her consent to the importing into, supplying in or exporting from, Australia of therapeutic goods (other than medical devices) that do not comply with an applicable standard.[86]

Item 1 of Schedule 8 of the Bill expands the definition of initial decision under subsection 60(1) of the TG Act to include a decision of the Secretary to impose a condition on the granting of a consent to the importing into, supply in or exporting from Australia of therapeutic goods that do not comply with an applicable standard under the Act. The effect of the amendment is to allow sponsors to seek merits review in relation to the imposition of conditions on the granting of consent under sections 14 and 14A of the TG Act.

Comments

There are no significant changes from the previous Bill.

Schedule 9

Item 1 of Schedule 9 of the Bill inserts proposed subsection 60(3C) into the TG Act to expressly provide that a substituted decision made by the Minister under paragraph 60(3)(b) is taken to be a decision by the Secretary (except for the purpose of review of the substituted decision)[87] and is effective on or from the date determined by the Minister. As stated in the Explanatory Memorandum, this amendment will support proposed section 25AB and the amendments to sections 25 and 25AA (in Schedule 5 above) as ‘it will allow the Secretary to complete the process of registration’ in the event of a substituted decision.[88]

Comments

There are no significant changes from the previous Bill.

Schedule 10

Kits are where two or more (listed, registered or exempt) goods are supplied in a single packaged product and tend to share a common therapeutic use and are intended for use as a unit. However, the individual goods can be used independently and do not need to be combined or administered in a sequence for the product's therapeutic purpose, for example: a sunscreen lotion and lip balm presented in a single package or a first aid kit.[89]

Under existing subsection 7B(1) of the TG Act, more than one therapeutic good must be included in the package for it to constitute a kit. Item 1 of Schedule 10 of the Bill repeals and replaces subsection 7B(1) of the TG Act to expand the meaning of ‘kit’ to include a package which contains one or more goods and, amongst other things, at least one of the goods is therapeutic goods.

Comments

There are no significant changes from the previous Bill.

Schedule 11

There is currently no criminal offence or civil penalty provision that applies to the provision of false or misleading information in relation to a statement made in connection with a request to vary an entry on the Register under section 9D of the TG Act.[90]

Item 1 of Schedule 11 of the Bill inserts proposed sections 9G and 9H to create a criminal offence provision and a civil penalty provision respectively arising from the making of false statements in requests for variation of entries in the Register.[91]

Proposed section 9G of the TG Act introduces a tiered approach to criminal sanctions for the provision of false or misleading information that is used to inform decisions that could potentially have serious consequences for public health. The tiered approach is consistent with other offence provisions in the Act[92] and operates as follows:

•       Tier 1: proposed subsection 9G(1) of the TG Act makes it an offence if a person provides false or misleading statements about or connected to a request under section 9D of the TG Act for the variation of an entry in the Register in relation to therapeutic goods if the use of the goods has resulted in, will result in, or would result in harm or injury to any person. This offence is punishable by up to five years’ imprisonment or 4,000 penalty units,[93] or both

•       Tier 2: proposed subsection 9G(2) of the TG Act makes it a strict liability offence[94] for a person to make a false or misleading statement about, or in connection with, a request under section 9D of the TG Act for the variation of an existing entry in the Register in relation to therapeutic goods and where the use of the goods, if the goods were used, would be likely to result in harm or injury to any person. This offence is punishable by up to a maximum penalty of 2,000 penalty units

•       Tier 3: proposed subsection 9G(3) of the TG Act makes it an offence if a person makes a false or misleading statement about or in connection with a request under section 9D of the TG Act for the variation of an existing entry in the Register in relation to therapeutic goods (and where no actual or likely harm to any person needs to be shown). This is punishable by imprisonment for 12 months or by a fine of 1,000 penalty units, or both.

Proposed subsection 9H of the TG Act is a civil penalty provision. A person who contravenes this section is subject to a civil penalty if the person makes a false or misleading statement about, or in connection with, a request under section 9D of the TG Act for the variation of an existing entry in the Register in relation to therapeutic goods. The maximum penalty is 5,000 penalty units for an individual or 50,000 penalty units for a corporation.

Committee concerns

Human Rights Committee

The Human Rights Committee has commented on the provisions of this Schedule in the first Bill (which are in equivalent terms) and considered that ‘the civil penalty provisions in this bill do not give rise to issues of incompatibility with human rights’.[95]

The Committee noted that the Statement of Compatibility together with the Explanatory Memorandum provide a specific justification for the use of a strict liability provision and a penalty higher than that recommended in the A Guide to Framing Commonwealth Offences, Civil Penalties and Enforcement Powers.[96]

The Explanatory Memorandum provides:

However, these penalty units are considered to be appropriate and necessary to reflect the seriousness of the conduct to which they relate and the potentially serious consequences for public health of such conduct. The penalty levels are also consistent with the maximum penalties for the existing offences in the Act mentioned above relating to the provision of false or misleading information in connection with an application for marketing approval.[97]

The Human Rights Committee also raised the issue of the possible ‘criminal nature’ of the civil penalty provision for the purposes of human rights law. However, the Human Rights Committee considered that:

Given that these civil penalty provisions appear in a regulatory and protective context, it is arguable that the penalties are not 'criminal' in nature. Although the penalties are large, it may be argued that they are not excessive in terms of a business and in view of the health interests of the public that are being protected.[98]

Scrutiny of Bills Committee

The Scrutiny of Bills Committee was concerned that the proposed strict liability offence ‘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’.[99] Whilst the Scrutiny of Bills Committee acknowledged the arguments presented in the Explanatory Memorandum to the Bill in support of this provision, it was still concerned at the lack of:

… an explanation as to why strict liability will significantly enhance effective regulatory enforcement and why it is legitimate to penalise persons who lack fault. The committee therefore seeks the Minister’s further explanation of this matter.[100]

The Parliamentary Secretary replied to the Scrutiny of Bills Committee as follows:

The information provided by a sponsor for the purposes of [a request for variation] can include complex and extensive scientific data about the goods, e.g., results of clinical trials, or the incidence of adverse reactions to prescription medicines. This information will be exclusively and confidentially within the knowledge of the sponsor. Moreover, it is up to the sponsor to demonstrate that the basis on which the product was approved for marketing in Australia (via inclusion on the Register)—i.e. that its quality, safety and efficacy/performance was acceptable—remains, and that, as such, it should continue to 'be on the Register notwithstanding the proposed change.

Thus there is a particular level of dependence on the accuracy and comprehensiveness of the supporting information provided to support a section 9D request, especially in relation to higher risk goods like prescription medicines. If the Secretary of the Department of Health and Ageing relies on false information to approve a request, there could potentially be serious consequences for public health and safety.

Where non-compliance with the requirement to provide accurate information that is not false or misleading is likely to cause harm or injury (as per proposed subsection 9G(2)), it is considered that non-compliance should attract a criminal sanction regardless of any mental element. By setting out a strong deterrence against providing false or misleading information, and by forming an integral part of the suite of sanctions proposed for such conduct, it is expected subsection 9G(2) will significantly enhance regulatory enforcement and help to protect the public from exposure to therapeutic goods that have been approved for continued supply on the basis of false or misleading information.

Proposed section 9G is consistent with the existing tiered criminal offences in the Act that apply in relation to the provision of false or misleading information (e.g. by applicants for the inclusion of products in the Register) , and with the current approach of tiered criminal offences in the Act which include in that structure an offence of strict liability along the same lines as proposed subsection 9G(2).[101]

After considering the Parliamentary Secretary’s response, the Committee had no further comment on this issue.[102]

Comments

There are no significant changes from the previous Bill.

Schedule 12

Item 1 of Schedule 12 of the Bill repeals and replaces paragraph 30(5)(b) of the TG Act to provide a specified period of time (being at least 20 working days after notification) before a cancellation of therapeutic goods from the Register occurs. The existing provision refers to ‘such later day as is specified in the notice’.

Comments

There are no significant changes from the previous Bill.

Schedule 13

Under the existing provisions of the TG Act, where publication is required, the Secretary must publish decisions made under the Act in the Australian Government Gazette. The amendments in Schedule 13 of the Bill allow the Secretary to publish certain decisions in either the Gazette or on the Department’s website or both.

Item 2 of Schedule 13 of the Bill inserts proposed section 30B into the TG Act—to require the Secretary to publish the particulars of any cancellation of registered or listed therapeutic goods either in the Gazette or on the Department’s website. Similarly, item 4 of Schedule 13 of the Bill amends most of the provisions under the TG Act which currently require or authorise the Secretary to publish information in the Gazette to require or authorise publication in the Gazette or on the Department’s website. Those provisions which are not amended are listed on pages 51-52 of the Explanatory Memorandum to the Bill.[103]

The purpose of this amendment is to provide greater flexibility in the manner in which various decisions made under the Act may be communicated to the general public.[104]

Industry concerns

ADIA does not support this proposed amendment. While ADIA would like to see decisions published on the website, it is of the opinion that decisions should also appear in the Gazette in ‘the interests of transparency and good regulatory process’.[105]

Committee views

The Community Affairs Committee raised the point that the new publication arrangements proposed under this Schedule of the Bill did not ‘extend to the Secretary's new powers under proposed section 9F with respect to a 'notice of removal'’.[106] Under proposed section 9F of the previous Bill the publication of a notice of removal would be on the TGA website only. The Community Affairs Committee noted that it was ‘unsure why the proposed “notice of removal” power would be the only one for which gazettal is not an option’.[107] That being the case, the Community Affairs Committee recommended that the Bill be amended to align the publication options between proposed section 9F and other existing provisions in the Act.[108] This concern has been addressed in the current Bill. Proposed subsection 9F(7) requires the Secretary to publish a notice in the Gazette or on the Department’s website in the event he or she approves the removal of an entry of goods from the Register.

The Community Affairs Committee was also concerned about the permanence and ongoing accessibility of records on the web (as contrasted to the Gazette). In this respect, the Committee sought ‘an undertaking from the government that there will be an equally permanent (and public) record of decisions published on the TGA's website as there is for those published in the Gazette’.[109]

Comments

There are no significant changes from the previous Bill.

Schedule 14

Kinds of medical devices are usually included in the Register automatically once a proper application is made, together with the required certification.[110] However, applications may be selected for audit, which involves checking some or all aspects of the application and certification.[111]

Subsection 41FH(1) of the TG Act requires the Secretary to select for auditing any application for a kind of medical device to be included in the Register that is an application of the kind prescribed by regulations. The Secretary also has discretion to select any other medical device application for auditing. Under current subsection 41FH(2), the Secretary is required to inform the applicant of the selection by written notice, within 20 days after the application was made. This written notice must include a request for information that may be relevant to the audit. Item 1 of Schedule 14 of the Bill repeals subsection 41FH(2) and inserts proposed subsections 41FH(2)–(4). The effect of this amendment is to allow for alternative periods of time within which the Secretary is required to give notice of selection for auditing to be prescribed. Therefore, new subsection 41FH(2) provides that the selection notice must be given within 20 working days after the application is made or if the regulations prescribe a longer period for that kind of application –that longer period.

According to the Explanatory Memorandum:

This reflects that it may often be difficult to identify all the information that will be necessary to complete an audit when the only material available to the Secretary to assist in making that assessment is the application itself.

It may be, for example, that a need for additional information will be identified as a result of reviewing information subsequently provided by the applicant in response to the Secretary’s request.

The new requirement is therefore intended to provide greater flexibility in this regard, and to refer to information the Secretary is satisfied, at the time of giving the applicant the selection notice, is relevant to the audit of the application.[112]

Comments

Schedule 14 of the previous Bill was entitled ‘Public notification and recovery’ and widened the circumstances under which the Secretary could require sponsors/suppliers to provide information to the public, relevant health care professionals and patients. It is unclear why these provisions were removed from the current Bill and replaced with the changes to the auditing requirements.

Schedule 15

Item 1 of Schedule 15 of the Bill amends subsection 30(2) of the TG Act to allow the Secretary to cancel the registration or listing of a product where the sponsor of the goods has failed to respond to a notice to provide information or documents within 14 days after the date specified in the notice for production of the material.[113]

Items 2 and 3 of Schedule 15 amend the TG Act so that the offences in the TG Act relating to failing to comply with a notice issued by the Secretary to provide information or documents about biologicals or medical devices (sections 32JB and 41JB respectively) will not apply if the person to whom the notice was issued had a reasonable excuse.[114]

Comments

There are no significant changes from the previous Bill.

Schedule 16

Schedule 16 of the Bill contains amendments which allow holders of manufacturing licences and conformity assessment certificates and sponsors of kinds of medical devices who asked the Secretary to cancel their devices, licences or certificates to request the Secretary to reverse the cancellation.[115]

Comments

These amendments were not contained in the previous Bill. Instead, Schedule 16 of the previous Bill amended section 9D (which deals with requests by sponsors to vary existing entries in the Register) and section 23 (which deals with applications for registration or listing of therapeutic goods) to enable the Secretary to specify, by legislative instrument, the information that must accompany such requests and applications.[116] These amendments are not included in the current Bill.

Concluding comments

The Department’s submission to the Community Affairs Committee notes:

No new policy initiatives for the regulation of the different classes of therapeutic goods are included in the Bill.

Most of the amendments either address anomalies that have arisen as a result of amendments to the Act at different times over recent years, or have been designed to ensure, where appropriate, consistent treatment of the different types of therapeutic goods regulated under the Act, including prescription, over-the-counter and complementary medicines, biologicals and medical devices.[117]

As a result, the measures are generally supported—especially as they endeavour to streamline, ‘modernise’ and improve the operational efficiency of the TG Act and continue to align the regulatory framework with the objects of the TG Act in an environment which is constantly evolving and changing.

The bigger issue of overall reform to the regulation of therapeutic goods is yet to come.

Members, Senators and Parliamentary staff can obtain further information from the Parliamentary Library on (02) 6277 2500.

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ISSN 1328-8091

[1].              Parliament of Australia, ‘Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013 homepage’, Australian Parliament website, accessed 22 January 2014.

[2].              Therapeutic Goods Act 1989, accessed 22 January 2014.

[3].              Since the TG Act came into force in 1989 it has undergone a number of reforms. For information about the TG Act is in its original form see Department of the Parliamentary Library, Therapeutic Goods Bill 1989, Bills digest 123, 1989, Parliamentary Library, Canberra, 24 October 1989, accessed 22 January 2014.

[4].              Department of Health, ‘About the Australian therapeutic goods legislation’, Therapeutic Goods Administration website, accessed 22 January 2014.

[5].              Department of Health, ‘Who we are and what we do’, Therapeutic Goods Administration website, accessed 22 January 2014.

[6].              Ibid.

[7].              Department of Health, ‘What the TGA regulates’, Therapeutic Goods Administration website, accessed 22 January 2014. The TGA regulates the supply, manufacture and advertising of these products. Medicines include those: prescribed by a doctor or dentist, available from behind the pharmacy counter, in the general pharmacy, from supermarkets, and complementary medicines. The meaning of biological is defined in section 32A of the TG Act.

[8].              Department of Health and Ageing, ‘The Australian Register of Therapeutic Goods’, Therapeutic Goods Administration website, accessed 5 February 2014.

[9].              Department of Health, ‘Transparency review of the TGA’, Therapeutic Goods Administration website, accessed 22 January 2014.

[10].              Working Group on Promotion of Therapeutic Products, Report to the Parliamentary Secretary Catherine King, 2011, accessed 22 January 2014.

[11].              Department of Health, ‘Advertising regulatory framework—options for reform’, Therapeutic Goods Administration website, accessed 22 January 2014.

[12].              Australian National Audit Office, Therapeutic goods regulation: complementary medicines, Auditor-General audit report no. 3, 2011–12, Commonwealth of Australia, 2011, accessed 22 January 2014.

[13].              Department of Health, ‘Reforms in the medical devices regulatory framework’, Therapeutic Goods Administration website, accessed 22 January 2014.

[14].              Department of Health, ‘Australian government health technology assessment review’, Department of Health website, accessed 22 January 2014.

[15].              Department of Health, ‘TGA reforms: a blueprint for TGA’s future’, Therapeutic Goods Administration website, accessed 22 January 2014.

[16].              Department of Health, ‘Delivering reforms—implementation plan for TGA Reforms: a blueprint for TGA's future’, Therapeutic Goods Administration website, accessed 22 January 2014.

[17].              Selection of Bills Committee, Report No. 11 of 2013, Senate, Canberra, 11 December 2013, accessed 22 January 2014.

[18].              Details about the terms of reference of the Committee, submissions by stakeholders and the final report are on the Community Affairs Committee inquiry page, accessed 22 January 2014.

[19].              Community Affairs Legislation Committee, Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013 [Provisions], Senate, Canberra, 2013, recommendation 1, p. vii, accessed 22 January 2014.

[20].              Ibid., recommendation 2.

[21].              Ibid., recommendation 3.

[22].              Ibid., recommendation 4.

[23].              Standing Committee for the Scrutiny of Bills, Alert Digest No. 5 of 2013, Senate, Canberra, 15 May 2013, pp. 99–101, accessed 22 January 2014.

[24].              Parliamentary Joint Committee on Human Rights, Sixth report of 2013, 15 May 2013, pp. 86–89, accessed 22 January 2014.

[25].              Ibid. In relation to the right to health, the Human Rights Committee noted that ‘The Bill seeks to improve the effectiveness of the therapeutic goods legislative regime to ensure that products or items which fall within the description of therapeutic goods and which may have an adverse impact on the health of individuals and the community are appropriately regulated. The Bill accordingly may be assessed as contributing to promoting the enjoyment of the right to the highest attainable standard of physical and mental health, as guaranteed by article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR)’.

[26].              Ibid., p. 87. The Human Rights Committee noted that the removal of the right to merits review (inserted by item 10 of Schedule 5 of the first Bill but now removed) engages the right of access to court, being the right of a fair hearing in the determination of rights and obligations in a suit at law, and the introduction of a new strict liability offence under Schedule 11 of the Bill engages the right to be presumed innocent and minimal criminal guarantees under article 14(1) and 14(2) of the ICCPR, respectively.

[27].              Ibid., p. 86.

[28].              Both the Scrutiny of Bills Committee and the Human Rights Committee commented on the strict liability offence under proposed sections 9G and 9H of the TG Act.

[29].              The Statement of Compatibility with Human Rights can be found at pages 5–7 of the Explanatory Memorandum to the Bill: Explanatory Memorandum, Therapeutic Goods Amendment (2013 Measures No.1) Bill 2013, pp. 5-7, accessed 11 February 2014.

[30].              Submissions to the Community Affairs Committee are on the inquiry page, accessed 22 January 2014.

[31].              Complementary Healthcare Council of Australia, Submission to the Senate Standing Committee on Community Affairs, Inquiry into the Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013, May 2013, accessed 22 January 2014.

[32].              ADIA, Submission to the Senate Standing Committee on Community Affairs, Inquiry into the Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013, accessed 22 January 2014.

[33].              Explanatory Memorandum, op. cit., p. 4.

[34].              The Therapeutic Goods Advertising Code is made by the Minister under section 42BAA of the TG Act. Therapeutic Goods Advertising Code 2007, accessed 22 January 2014.

[35].              Item 22 in Schedule 1 of the previous Bill.

[36].              TG Act, paragraphs 31(1)(aa)–(ac).

[37].              Items 11 and 13 of Schedule 2 make similar amendments with regards to biologicals and medical devices.

[38].              Section 32A sets out the meaning of the term biological for the purposes of the TG Act.

[39].              This reflects the current situation for applicants who wish to list therapeutic goods: TG Act, subsection 31(4).

[40].              Items 3, 13 and 17 of the previous Bill.

[41].              TG Act, proposed subsection 7AA(1).

[42].              TG Act, proposed subsection 7AA(2).

[43].              A legislative instrument can be subject to disallowance if either a Senator or Member of the House of Representatives moves a motion of disallowance within 15 sitting days of the day that the legislative instrument is tabled. The motion to disallow must be resolved or withdrawn within a further 15 sitting days of the day that the notice of motion is given. If there is no notice of motion to disallow a legislative instrument, then there is no debate about its contents.

[44].              TG Act, proposed subsection 7AA(4).

[45].              Department of Health and Ageing, Answers to Questions on Notice to the Senate Standing Committee on Community Affairs, Inquiry into the Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013, 28 May 2013, p. 10, accessed 24 January 2014.

[46].              Ibid., p. 9.

[47].              Explanatory Memorandum, Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013, p. 20.

[48].              Ibid., p. 21.

[49].              Department of Health and Ageing, Submission to the Senate Standing Committee on Community Affairs, Inquiry into the Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013, 3 May 2013, p. 5, accessed 24 January 2014.

[50].              Medicines Australia, Submission to the Senate Standing Committee on Community Affairs, Inquiry into the Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013, 3 May 2013, p. 2 accessed 24 January 2014.

[51].              Australian Medical Association (AMA), Submission to the Senate Standing Committee on Community Affairs, Inquiry into the Therapeutic Goods Amendment (2013 Measures No. 1) Bill, 2 May 2013, accessed 24 January 2014.

[52].              Competition and Consumer Act 2010, accessed 9 February 2014.

[53].              Australian Medical Association (AMA), Submission to the Senate Standing Committee on Community Affairs, Inquiry into the Therapeutic Goods Amendment (2013 Measures No. 1) Bill, op. cit.

[54].              In the first Bill, proposed section 7AA did not include proposed subsections 7AA(3) and (4), and so did not set out factors that the Minister must consider in making a determination.

[55].              Scrutiny of Bills Committee, Alert Digest No. 5 of 2013, op. cit., p. 100.

[56].              Senate Community Affairs Legislation Committee, Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013 [Provisions], op. cit.,
pp. 22–23.

[57].              According to proposed subsection 9F(5) of the TG Act a notice given under proposed subsection 9F(2) is not a legislative instrument. The Explanatory Memorandum notes that such notices would not appear to be legislative instruments within the meaning of section 5 of the Legislative Instruments Act 2003.

[58].              Senate Community Affairs Legislation Committee, Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013 [Provisions], op. cit., Recommendation 3.

[59].              Explanatory Memorandum, pp. 2 and 23. This may be done using the Device Electronic Application Lodgement system (DEAL) under subsection 41FF(1) of the TG Act on the basis of certifications made by the applicant under section 41FD of the Act. In such circumstances the electronic listing process does not provide an opportunity for TGA to screen an application and establish that the relevant goods are therapeutic goods prior to listing.

[60].              DoHA, Submission to the Senate Standing Committee on Community Affairs, Inquiry into the Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013, op. cit., p. 6.

[61].              Ibid.

[62].              TG Act, subsection 42DL(1)(c).

[63].              For example under paragraph 25(1)(d) of the TG Act the Secretary must consider whether the quality, safety and efficacy of the goods for the purposes for which they are to be used have been satisfactorily established.

[64].              This power has been understood as having been implied within section 25 of the TG Act by virtue of the steps which must be undertaken under subsections 25(3) and 25(4) to notify applicants of a decision: Explanatory Memorandum, op. cit., p. 27.

[65].              Under subsections 3(2A) and(2B) of the TG Act, the Minister may by legislative instrument specify medicines or classes of medicine as restricted medicines.

[66].              TG Act, proposed subsection 25AA(1A).

[67].              Section 3 of the TG Act defines a therapeutic device as therapeutic goods (other than biologicals) consisting of an instrument, apparatus, appliance, material or other article (whether for use alone or in combination), together with any accessories or software required for its proper functioning, which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means though it may be assisted in its function by such means, but the expression does not include therapeutic goods declared by the Secretary, by order published in the Gazette, not to be therapeutic devices.

[68].              Explanatory Memorandum, p. 32.

[69].              TG Act, section 3.

[70].              TG Act, paragraph 25(1)(e):Registration of goods, paragraph 26(1)(e): listing of therapeutic goods and paragraph 26A(2)(c): listing of certain medicines.

[71].              In contrast, under subsection 30(1) of the TG Act, the notice in writing is given to the person in relation to whom therapeutic goods are listed in the Register.

[72].              Under subsection 32GC(1) of the TG Act the Secretary may cancel the entry of a biological from the Register if the presentation of the biological is unacceptable.

[73].              The procedural requirements associated with the Secretary’s cancellation powers under subsection 30(2) of the TG Act also apply to this new ground. These include, for example, notification requirements and consideration of submissions. The Secretary also has the option of suspending the goods from the Register for a period of not more than six months (section 29D).

[74].              Department of Health, ‘Listing notices’, Therapeutic Goods Administration website, accessed 22 January 2014.

[75].              Department of Health, ‘Medicines and TGA classifications’, Therapeutic Goods Administration website, accessed 22 January 2014.

[76].              Explanatory Memorandum, p. 37.

[77].              Senate Community Affairs Legislation Committee, Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013 [Provisions], op. cit., p.11.

[78].              Therapeutic Goods Regulations 1990, accessed 9 February 2014.

[79].              Explanatory Memorandum, p. 37.

[80].              Medicines Australia, Submission to the Senate Standing Community Affairs Legislation Committee, Inquiry into the Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013, op. cit.

[81].              Generic Medicines Industry Association, Submission to the Senate Standing Community Affairs Legislation Committee, Inquiry into the Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013, op. cit., p. 2.

[82].              Ibid., p. 3.

[83].              As noted in the Community Affairs Committee report: Senate Community Affairs Legislation Committee, Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013 [Provisions], op. cit., p. 15.

[84].              Ibid., p. 15.

[85].              Senate Community Affairs Legislation Committee, Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013 [Provisions], op. cit., p. 16.

[86].              Explanatory Memorandum, p. 40.

[87].              The purpose of this exclusion is to ensure that any person affected by a substituted decision by the Minister can still appeal to the Administrative Appeal Tribunal (TG Act, subsection 60(8)): Ibid., p. 41.

[88].              Ibid.

[89].              Department of Health, Complementary medicines presented as composite pack or kits, Therapeutic Goods Administration website, accessed 28 January 2014.

[90].              Under section 9D of the TG Act, the Secretary may vary an entry in the Register, upon request by a person in relation to whom therapeutic goods are entered on the Register or on the Secretary’s own initiative, if the entry contains information that is incomplete or incorrect.

[91].              It is also noted that section 137.1 of the Criminal Code Act 1995 (Cth) establishes the offence of giving false and misleading information to a Commonwealth entity, to a person acting in connection with a law of the Commonwealth or in compliance with a Commonwealth law.

[92].              Explanatory Memorandum, p. 46. It replicates the three tiered system found elsewhere in the TG Act (with higher penalty levels applying where use of the goods has had, or will or would have, serious health consequences and with an alternative civil penalty provision). It is also noted at page 6 of the Explanatory Memorandum that variations to goods listed on the Register ‘can relate to a variety of matters, including quite serious safety issues, such as adding a warning or a precaution to the product information of a prescription medicine in connection with the use of the medicine’.

[93].              Section 4AA of the Crimes Act 1914 (Cth) provides that a penalty unit is equivalent to $170. This means that the maximum penalty amounts to $680,000.

[94].              For an offence of strict liability created under a law there are no fault elements for any physical elements of the offence and the defence of mistake of fact is available. See sections 6.1 and 9.2 of the Criminal Code Act 1995 (Cth). The Guide to Framing Commonwealth Offences, Infringement Notices and Enforcement Powers (the Guide) states that ‘strict and absolute liability should only be used in limited circumstances and where there is adequate justification for doing so’: Attorney-General’s Department (AGD), A Guide to framing Commonwealth offences, infringement notices and enforcement powers, September 2011 edition, AGD, p. 22, accessed 28 January 2014.

[95].              Parliamentary Joint Committee on Human Rights, Sixth Report of 2013, op. cit., p. 89.

[96].              Ibid.

[97].              Explanatory Memorandum, op. cit., p. 46.

[98].              Parliamentary Joint Committee on Human Rights, Sixth Report of 2013, op. cit., p. 89.

[99].              Scrutiny of Bills Committee, Alert Digest No. 5 of 2013, op. cit., p. 101. The Committee noted that the maximum penalty is 2,000 penalty units, which is well above the maximum penalty recommended by the Guide to Framing Commonwealth Offences (60 penalty units for an individual and 300 units for a body corporate).

[100].              Ibid., p. 101.

[101].              S Neumann (Parliamentary Secretary for Health and Ageing), Letter to the Senate Scrutiny of Bills Committee dated 17 June 2013, in Senate Standing Committee for the Scrutiny of Bills, Sixth report of 2013, June 2013, p. 235, accessed 28 January 2014.

[102].              Ibid., p. 240.

[103].              Explanatory Memorandum, op. cit., pp. 51-52.

[104].              DoHA, Submission to the Senate Standing Committee on Community Affairs, Inquiry into the Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013, op. cit., p. 11.

[105].              ADIA, Submission to the Senate Standing Committee on Community Affairs, Inquiry into the Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013, op. cit., p. 8.

[106].              Senate Community Affairs Legislation Committee, Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013 [Provisions], op. cit., p. 35.

[107].              Ibid., p. 36.

[108].              Ibid.

[109].              Ibid.

[110]. Section 41BE of the TG Act sets out when a medical device is taken to be of the same ‘kind’ as another medical device.

[111].              TG Act, section 41FA.

[112].              Explanatory Memorandum, p.54.

[113].              TG Act, proposed paragraph 30(2)(caa).

[114].              The defendant wears the burden of proof: TG Act, proposed subsections 32JB(1A) and 41JB(3A).

[115].              Further information on these amendments is set out at pages 59-61 of the Explanatory Memorandum to this Bill.

[116].              Explanatory Memorandum, Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013, p. 60, accessed 11 February 2014.

[117].              DoHA, Submission to the Senate Standing Committee on Community Affairs, Inquiry into the Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013, op. cit., p. 4.