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Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009

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2008-2009

 

 

 

 

 

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

 

 

 

 

 

HOUSE OF REPRESENTATIVES

 

 

 

 

 

 

 

THERAPEUTIC GOODS AMENDMENT (2009 MEASURES NO. 2) BILL 2009

 

 

 

 

 

 

 

 

 

EXPLANATORY MEMORANDUM

 

 

 

 

 

 

 

 

 

 

 

 

 

(Circulated by authority of the Hon Mark Butler MP, Parliamentary Secretary for Health)

 





THERAPEUTIC GOODS AMENDMENT (2009 MEASURES NO. 2) BILL 2009

 

OUTLINE

The Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 (the Bill) makes a series of amendments to the Therapeutic Goods Act 1989 (the Act).  These include:

  • introducing new arrangements for the separate scheduling of medicines and poisons;
  • enabling the Secretary to declare purposes for which a kind of device cannot be included in the Register;
  • extending the circumstances in which consultation can occur with, and where advice can be requested from, the Gene Technology Regulator regarding applications for the listing or registration in the Register of therapeutic goods that are, or that contain, genetically modified organisms;
  • amending the advertising offence provisions to provide that it is an offence for any person to advertise a therapeutic good inappropriately;
  • amending delegation provisions to enable the regulations to specify a relevant person for the purposes of exercising delegation under section 19A of the Act; and
  • introducing provisions that would allow the Minister, by legislative instrument, to specify advisory statements that are required to be included on the labels of  specified medicines.

 

New arrangements for the separate scheduling of medicines and poisons

Presently Part 6-3 of the Act provides for the joint scheduling of medicines and poisons by the National Drugs and Poisons Scheduling Committee.  Decisions of the Committee are then incorporated in the Poisons Standard adopted for implementation by the states and territories.  The Poisons Standard is principally used by the states and territories as a tool for regulating public access to and availability of medicines, veterinary, agricultural and domestic chemicals.

 

This Bill will implement amendments deferred following the postponement in July 2007 of the establishment of the Australian New Zealand Therapeutic Products Authority (ANZTPA).

 

These deferred amendments arose from the National Competition Review of Drugs, Poisons and Controlled Substances Legislation undertaken by Rhonda Galbally (the Galbally Review) provided to the Australian Health Ministers’ Conference in 2001.  Following consideration by the Australian Commonwealth, state and territory governments the recommendations of the Galbally Review were to be implemented within a trans-Tasman context.

 

While most of the recommendations from the Galbally Review were implemented during 2006-07, further implementation was delayed following postponement of ANZTPA.  The scheduling amendments in this Bill implement the outstanding deferred recommendations in an Australian-only context.

 

In implementing these deferred amendments, this Bill will provide that medicines, including biologicals and other therapeutic goods, and poisons will be assessed and scheduled by the Secretary on the advice of separate expert committees, where required.  Decisions will be included in a single legislative instrument, the ‘Poisons Standard’, for adoption by each state and territory in their respective implementing legislation.

 

These amendments reflect extensive consultation with industry and other interested parties and also implement a recommendation of the Productivity Commission’s Research Report on Chemicals and Plastics Regulation.

 

Precluding medical devices from inclusion in the Register where the intended purpose poses a public health risk

At present the Act provides that a kind of medical device that satisfies all of the application and certification requirements under the Act is to be included in the Register.  These requirements include certifications by the applicant that the kind of medical device complies with the essential principles, the device of the kind is intended for a specified purpose, as ascertained under subsection 41BD(2), and that an appropriate conformity assessment procedure has been applied to the device of that kind.  However, despite a kind of device satisfying all these requirements, there may be certain uses for these devices that in specified circumstances would pose risks to public health or the individuals using them.

 

The Bill will provide that a kind of medical device can be precluded from entry in the Register, and therefore supply precluded, where the only intended purpose for that kind of device is determined as an excluded purpose.  This will support safety and quality in use of kinds of devices that would be unsafe or inappropriate if used for certain purposes or in certain ways, such as home-testing for serious illnesses where the person would not have the necessary medical support to understand the implications of the result or notify health authorities if it was a notifiable condition.

 

Other amendments

Other amendments will be made to the Act by this Bill.  The most significant include providing that consultation can occur with the Gene Technology Regulator regarding genetically modified organisms in addition to genetically modified products; providing that it is an offence for any person to inappropriately advertise a therapeutic good; and empowering the Minister to determine by legislative instrument specific advisory statements that are required to be included on the labels of specified medicines.  These advisory statements are currently included in a document called the “Required Advisory Statements for Medicine Labels” and are enforced under the Therapeutic Goods Regulations 1990 and other legislative instruments under the Act.

 

FINANCIAL IMPACT STATEMENT

The amendments made by this Bill will have a nil financial impact on the Commonwealth as the Therapeutic Goods Administration, which implements the Act, operates on a cost recovery basis.  



THERAPEUTIC GOODS AMENDMENT (2009 MEASURES NO. 2) BILL 2009

 

NOTES ON CLAUSES

Clause 1: Short Title

Clause 1 is a formal provision specifying the short title of the Bill, once enacted, as the Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009 .

Clause 2: Commencement

This clause provides that the Bill commences on Royal Assent and that the various Schedules commence as set out in the table.

 

Schedule 1 commences on 1 July 2010.  A fixed date will provide certainty to pharmaceutical and chemical industries and interested parties about the new arrangements for the separate scheduling of medicines and chemicals.  This will also provide the necessary time to enable finalisation of subordinate legislation to support the new scheduling framework and for affected parties to make arrangements for complying with the new arrangements including in relation to making applications.

 

Schedules 2 and Part 1 of Schedule 3 commence on the day after Royal Assent, as it is important that the Government is able to preclude medical devices intended for a purpose that may pose a risk to public health from entry in the Register; prevent inappropriate advertising of therapeutic goods; consult with and request advice from the Gene Technology Regulator regarding genetically modified organisms; and exercise clearer delegation arrangements, immediately following Royal Assent.

 

Part 2 of Schedule 3 commences on a day to be proclaimed to enable the provisions in that part to commence simultaneously with the legislative instrument to be made by the Minister under that Part.

Clause 3: Schedule(s)

This clause provides that each Act that is specified in a Schedule to this Bill is amended or repealed as set out in the relevant Schedule, and any other item in a Schedule to this Bill has effect in the way set out in the provision.  The Bill makes amendments to the Therapeutic Goods Act 1989 (the Act) and includes application and transitional provisions.

 



SCHEDULE 1 - SCHEDULING OF SUBSTANCES

 

Part 6-3 of the Act currently provides for the establishment of the National Drugs and Poisons Schedule Committee (the current Committee), its functions, and the preparation and amendment of the Poisons Standard.

 

The Poisons Standard is prepared, maintained and amended by the current Committee under the terms of the Act and the regulations.  The Poisons Standard consists of decisions of the current Committee regarding the classification of drugs and poisons into different Schedules signifying degree of risk.  Public access to substances included in a Schedule is then regulated under relevant States/Territories legislation according to which Schedule the substances appear in. 

 

Schedule 1 of the Bill provides the framework for separate arrangements for the scheduling of medicines and poisons consistent with the 2001 recommendations from the Galbally Review, and the decisions of the Australian Health Ministers’ Conference and the Council of Australian Governments.  It also implements a more recent recommendation of the Productivity Commission’s Research Report on Chemicals and Plastics Regulation which has been accepted by the Council of Australian Governments.

 

Item 1

This item replaces the heading of Part 6-3 with the heading ‘Scheduling of substances’ to make clear, for the benefit of readers, that the Part deals broadly with the scheduling of substances.

 

Item 2

This item inserts a new section 52AA which provides for an overview of this Part to explain the purpose and intent of the Part and to assist interpretation of provisions within it.

 

Items 3 to 7

These items amend section 52A to make a number of amendments to the definitions relating to the scheduling of substances used within the Part.

 

Item 3 inserts a new subsection number (1) before the words ‘In this Part’ as a consequence of the addition of a new subsection under this section (item 7 refers).

 

Item 4 repeals the definition of Committee , as the National Drugs and Poisons Schedule Committee is to be disbanded and this Bill provides for the establishment of two new scheduling advisory committees for medicines and chemicals (item 8 refers).

 

Item 5 amends the definition of current Poisons Standard in paragraph 52A(b) to reflect that the Poisons Standard is the document prepared under paragraph 52D(2)(b), including its amendments (item 10 refers).

 

Item 6 replaces the definition of substance at section 52A with a new definition to reflect comprehensively the substances that may be considered for scheduling by the Secretary, and which the new Committees may consider and advise the Secretary on.

 

The new definition of a substance includes the following:

(a)     an ingredient, compound, material or preparation which, or the use of which, may cause death, illness or injury to persons or animals;

(b)    an ingredient, compound, material or preparation included in a legislative instrument made by the Secretary under new subsection 52A(2) for the purposes of this paragraph; and

(c)     any ingredient, compound, material or preparation referred to in a schedule to the current Poisons Standard, as in force immediately before 1 July 2010.

 

Item 7 inserts new subsection 52A(2) to provide that the Secretary may, by legislative instrument, specify an ingredient, compound, material or preparation to be a substance for the purposes of paragraph (b) of the new definition of substance at item 6.

 

Items 8 and 9

These items provide for the establishment of two new committees to provide advice to the Secretary on the scheduling of medicines and chemicals.

 

Item 8 replaces sections 52B and 52C with provisions for the establishment, functions and membership of the Advisory Committee on Medicines Scheduling (ACMS) under new section 52B, and the Advisory Committee on Chemicals Scheduling (ACCS) under new section 52C.

 

New subsections 52B(1) and 52C(1) establish the ACMS and the ACCS, while subsections (2) of the new sections provides that the Committees be constituted and hold meetings in accordance with regulations made for that purpose.

 

New subsections 52B(3) and 52C(3) provide that the Commonwealth, states, the Australian Capital Territory and the Northern Territory can nominate a member of each Committee in accordance with the regulations made for the purposes of these subsections.  State and territory membership has been provided for to ensure uniform scheduling, and thus supply and availability, of scheduled substances across Australia.

 

The functions of the ACMS and ACCS are set out under new subsections 52B(4) and 52C(4), respectively.

 

Paragraph 52B(4)(a) enables the ACMS, subject to new subsection (5), to make recommendations to the Secretary regarding the classification and scheduling of substances, or classes of substances, that are, or are included in, therapeutic goods (as defined under subsection 3(1) of the Act, which limits these goods to use in humans).  Classes of substances may include, for example, antibiotics or antihistamines.  This will ensure consistency in consideration by the ACMS of like substances.  

 

Paragraph 52C(4)(a) provides that the ACCS can make recommendations to the Secretary regarding the classification and scheduling of substances subject to new subsection (5) which limits recommendations to substances that are not , or not included in, therapeutic goods.

 

Paragraphs (4)(b) of sections 52B and 52C enable the ACMS and the ACCS to make recommendations to the Secretary in relation to other changes (other than the Schedules) to the current Poisons Standard.  Paragraphs (4)(c) of sections 52B and 52C enable the committees to reconsider a recommendation made under paragraph (a) or (b) if the Secretary requests the reconsideration.



Paragraphs (4)(d) of sections 52B and 52C enable the Committees to provide advice to the Secretary regarding the restrictions to be imposed in respect of a particular substance, including restrictions regarding access and availability of the substance.  

 

Paragraphs (4)(e) and (4)(f) of sections 52B and 52C provide that the Committees can provide advice to the Secretary in relation to any other matter that the Secretary refers to it or any other functions set out in the regulations.

 

New subsection 52B(5) limits the function conferred on the ACMS under paragraphs 52B(4)(a) and (d) to the making of recommendations and the provision of advice to the Secretary in relation substances to the extent to which the substances are, or are included in, therapeutic goods.  Therefore, if a substance is included in both a medicine and a chemical, the ACMS can provide advice to the Secretary in regard to the substance only in relation to its use in medicines for human use.

 

New subsection 52C(5) mirrors this provision for the ACCS by limiting the functions of the ACCS under paragraphs 52C(4)(a) and (d) to the making of recommendations and the provision of advice to the Secretary in relation substances to the extent to which the substances are not , or are not included in , therapeutic goods.  Therefore, for a substance such as that referred to above in relation to new subsection 52B(5), the ACCS may provide advice to the Secretary regarding that substance in products that are not or are not included in therapeutic goods, such as in veterinary medicines intended for the treatment of animals.

 

New section 52CA explains that the ACMS and the ACCS may hold joint meetings as it may be necessary or expedient to do so, in accordance with the regulations.  For example, this may occur to consider a substance that has use both as a medicine and as a chemical.

 

Consequent to the repeal of the definition of committee (item 4 refers) and the insertion of new sections 52B and 52C to create two new advisory committees (item 8 refers), item 9 removes the reference under subsection 52D(1) to the ‘Committee’ and replaces it with reference to the ‘then National Drugs and Poisons Schedule Committee’ (NDPSC). This reflects that the first Poisons Standard is to be taken to have been prepared and made available by the NDPSC.

 

Items 10 and 11

These items repeal existing subsections 52D(2) to (4), which are substituted with new subsections 52D(2) and (3), and add a new subsection 52D(4B) relating to the Poisons Standard.

 

Item 10 repeals subsections 52D(2) to (4), relating to amending or replacing the current Poisons Standard and gazettal requirements, to reflect that the Secretary will now be responsible for amending the current Poisons Standard, supported by the new advisory committees (item 8 refers).

 

Replacing these subsections will be new subsections 52D(2) and (3).  Subsection 52D(2) will provide that, subject to the Act and the regulations, the Secretary may amend the current Poisons Standard or prepare a new document which would include schedules with the names or descriptions of substances, or classes of substances, in substitution for the current Poisons Standard.  New subsection 52E(1) sets out the matters that the Secretary must have regard to when exercising these powers (item 12 refers).



Subsection 52D(3) explains that the Secretary may amend or prepare a new Poisons Standard in substitution for the current Poisons Standard either on her or his own initiative or following an application under new section 52EAA (item 12 refers).

 

The current legislative character of the current Poisons Standard is not altered by the amendments made by this Schedule and it remains a legislative instrument exempt from disallowance under the Legislative Instruments Act 2003 .

 

The exemption from disallowance reflects that, although the above amendments will result in the Secretary making an instrument (being the current Poisons Standard), she or he will do so having taken into consideration the expert advice of the new Committees.  These Committees will include members nominated by each state, the Australian Capital Territory and the Northern Territory, and the instrument will continue to be adopted into the legislation of each of these states and territories for implementation as occurs currently.  Therefore, the decision by the Secretary under new subsection 52D(2) and the resulting instrument remain a part of a joint Commonwealth- state/territory framework for the scheduling of medicines and chemicals.

 

It is not appropriate for a decision under new subsection 52D(2) to be merits reviewable.  Firstly, the decision to amend or replace the current Poisons Standard is legislative in character.  That decision is reflected in the Poisons Standard which is a legislative instrument.  In addition, a decision to amend or replace, or not amend or not replace, the current Poisons Standard will apply to all products containing the scheduled substance or class of substances and will thus apply to all manufacturers, importers, sponsors or suppliers of such products and not exclusively to the applicant for the scheduling or rescheduling of such a substance.

 

Further, decisions of the Secretary to amend or replace the current Poisons Standard will be informed by expert advice from expert committees, including the new Committees which include members from the states, the Australian Capital Territory and the Northern Territory.  These jurisdictions then implement the decisions in their relevant legislation.  It would also not be appropriate for decisions under new subsection 52D(2) to be merits reviewable because any decision made on review to alter a decision of the Secretary may result in a legislative decision.

 

Item 11 inserts new subsection 52D(4B) to provide that, despite subsection 14(2) of the Legislative Instruments Act 2003 , the current Poisons Standard as amended or replaced under section 52D(2) may make provision in relation to a matter by applying, adopting or incorporating a matter contained in an instrument or other writing as that is in force or existing from time to time.

 

This would enable the current Poisons Standard to apply, adopt or incorporate international standards and other instruments relating to the safe handling and supply of therapeutic goods and other substances.  The Poisons Standard, for example, refers to Australian and international standards on child-resistant packaging, the ‘the Australian Standard for packaging for poisonous substances’ and the ‘Required Advisory Statements for Medicine Labels’ (the RASML) (proposed to be made a legislative instrument as set out in Schedule 3 of this Bill).

 

This new subsection is necessary to ensure that the current Poisons Standard can reflect the broader international and national legislative and regulatory environment in which it operates.  It will also ensure consistency and a reduced regulatory compliance burden for those affected by the current Poisons Standard.  This is because it will enable updated instruments and documents that relate to scheduled substances to be incorporated and to apply as they are revised, rather than a lag period occurring between the revision and its recognition in the Standard.

 

Item 12

This item replaces existing section 52E and inserts a new section 52E in relation to the exercise of the Secretary’s powers and the making of applications to seek amendment to the Poisons Standard.

 

New subsection 52E(1) sets out the matters to which the Secretary must have regard when amending or replacing the current Poisons Standard under new subsection 52D(2) (item 10 refers).  These matters reflect the risks, benefits, usage, purpose, safety and other characteristics, relevant to protecting public health, of substances when including them in the current Poisons Standard, or when deciding to change the scheduling of a substance included in the current Poisons Standard.

 

New subsection 52E(2) provides that, further to these matters, the Secretary, in amending or replacing the current Poisons Standard, must comply with any guidelines of the Australian Health Ministers’ Advisory Council and its subcommittee, the National Co-ordinating Committee on Therapeutic Goods (or its replacement), notified to the Secretary for the purposes of this subsection.  This will ensure that decisions regarding the scheduling of substances will reflect national requirements.

 

New subsection 52E(3) provides that in amending or replacing the current Poisons Standard, the Secretary is also required to have regard to any recommendations or advice provided by either or both of the two new advisory Committees (item 8 refers).

 

New subsection 52E(4) provides that the Secretary may also seek and take into consideration the advice from another committee where the Secretary considers this appropriate, or the advice of any person.  The expert committee that the Secretary may seek advice from is not limited to those established under the Act or the Therapeutic Goods Regulations 1990.  This may include, for example, seeking the advice from an international expert on a particular substance.

 

New subsection 52E(5) explains that subsections (2) and (4) do not limit the information that the Secretary can take into consideration when amending or replacing the current Poisons Standard under subsection 52D(2).

 

Item 12 also inserts new section 52EAA providing for applications to be made to the Secretary to seek an amendment to the current Poisons Standard.  The new section provides that the application be in a form approved by the Secretary, provide details of the amendment sought and be delivered to an office of the Department, as specified in the form, along with the prescribed application fee.  The new section empowers the Secretary to require the applicant to provide further information concerning the application, as specified in a written notice given to the person.

 

New subsection 52EAA(4) provides that an approval of a form mentioned in new paragraph 52EAA (2)(a) or a notice from the Secretary in new subsection 52EAA(3) may require or permit an application or information to be given in an electronic form.  New subsection 52D(3) provides that the Secretary may amend the current Poisons Standard following an application made under section 52EAA (item 10 refers).

 

It is intended that the regulations will set out the public consultation process and procedures for the expert committees in relation to the making of scheduling or rescheduling decisions by the Secretary.

 

Item 13

This item sets out transitional provisions in relation to the validity of the current Poisons Standard and applications to amend that Standard, received before the commencement of this Schedule (i.e. 1 July 2010).

 

Subitem (1) explains that item 10 (empowering the Secretary to amend or replace the Standard) does not affect the validity of the current Poisons Standard as made and as amended and in effect before item 10 commences.  This preserves the validity of the current Poisons Standard (including amendments made to it) until it is amended or replaced by the Secretary under the new provisions in section 52D as set out in item 10.  This subitem covers all decisions made by the National Drugs and Poisons Schedule Committee (NDPSC) under new paragraphs 52D(2)(a) and (b) which are embodied in the version of the Poisons Standard registered in the Federal Register of Legislative Instruments (FRLI) before item 10 commences.

 

Subitem (2) provides that if an application was made on or after 1 January 2010 but before 1 July 2010 to the previous committee (the NDPSC) under section 52B to seek amendment to the current Poisons Standard, and that committee had proposed to amend the current Poisons Standard but that amendment had not been implemented in the version of the Poisons Standard registered in FRLI before 1 July 2010, then the Secretary must have regard to the proposal made by the NDPSC when amending or replacing the current Poisons Standard for the first time under subsection 52D(2), after 1 July 2010.  This item would cover, for example, an application that was received after 1 January 2010 to move a substance to a different schedule and the NDPSC, at a subsequent meeting, proposed that this occur, but that this decision to amend the Poisons Standard had not been registered in FRLI before 1 July 2010.

 

The effect of this subitem is to ensure that the Secretary considers the amendments proposed by the previous committee but which had not occurred due to time or other constraints between when the proposal was made and 1 July 2010 when the new arrangements under this Schedule commence.

 

Subitem (3) provides that if an application has been made on or after 1 January 2010 but before 1 July 2010, to the NDPSC under section 52B, to seek amendment to the current Poisons Standard and that application has not been refused or an amendment made to the Standard by that Committee before 1 July 2010, the application is taken to have been made to the Secretary in accordance with new section 52EAA of the Act (item 12 refers).

 

The effect of this subitem is to enable an application that was made to the NDPSC and that was still being considered by that committee to be carried over to be considered under the new arrangements by the Secretary in the circumstances set out. 

 

The application of this subitem differs in relation to the application of subitem 2.  Subitem 3 only deals with applications for scheduling received between 1 January 2010 and 30 June 2010. That is, if the application had not been refused by the previous Committee before the commencement of this item, and either the application has not yet been dealt with by the previous Committee at any of their meetings or no proposed decision to amend or replace the Poisons Standard has been made by the previous committee in relation to a particular application, subitem 3 provides that the application has affect as if it were made under the new arrangements under new section 52EAA. 

 

 

 



SCHEDULE 2 - MEDICAL DEVICES

 

Chapter 4 of the Act provides for the regulation of kinds of medical devices as a distinct group of therapeutic goods.  At present the Act provides that a kind of medical device that satisfies all the application and certification requirements under the Act are to be included in the Register.  These requirements include certifications by the applicant that the kind of medical device complies with the essential principles, the device of the kind is intended for a specified purpose, as ascertained under subsection 41BD(2), and that an appropriate conformity assessment procedure has been applied to the device of that kind.  However, despite a kind of device satisfying all these requirements, there may be certain uses for these devices that in specified circumstances would pose risks to public health or the individuals using them.

 

Items 1 and 2

These items authorise the Secretary to specify purposes applying to kinds of devices such that if an application were made for a device to be included in the Register and the intended purpose of the device is exclusively for a purpose specified by the Secretary, then the device will be precluded from being entered in the Register.

 

Item 1 inserts new section 41BEA to empower the Secretary to specify, by legislative instrument, a purpose or purposes for a kind of medical device.  Item 2 then provides that an applicant seeking to include a medical device(s) in the Register must certify that devices of that kind are not to be used exclusively for one or more of the purposes specified in the instrument made under section 41BEA (item 1 refers).

 

In practice this will mean that where a device is intended for two purposes and one of those purposes is an excluded purpose (item 1 refers), and the other purpose is not excluded then the device may be included in the Register, but only for the purpose that is not excluded.  As a result the device would only be legally able to be made available for the non-excluded purpose.

 

The certification is in relation to ‘devices of a kind’ because Chapter 4 of the Act enables inclusion in the Register of devices of a kind.  For example, an applicant may seek inclusion in the register of transdermal needles of varying sizes but they would all be included together as devices of a kind.  In practice, then, new section 41BEA would provide, by way of example, that if the needles were intended for a use specified in the instrument made under paragraph 41FD(ia), then they would not be eligible to be included in the Register for that purpose.

 

If an applicant certifies under paragraph 41FD(ia) that the intended purpose is not an excluded purpose, and this certification is found to be false or misleading, the person would be subject to the offence and civil penalty provisions of the Act under sections 41FE and 41FEA.  This is to ensure that applicants do not attempt to have a device included in the Register for an excluded purpose.

 

Item 3

This item inserts new subsection 41FF(1A) to require that where an application is made to include in the Register a kind of medical device, but the Secretary is satisfied that the kind of device is to be used solely for one or more excluded purposes specified under section 41BEA (item 1 refers), she or he must not include the kind of device in the Register in relation to the applicant.

 

A decision of the Secretary under new subsection 41FF(1A) would be informed by the certification made by the applicant under new paragraph 41FD(ia) (item 2 refers).

 

Item 4

This item provides that the amendments made by items 2 and 3 relating to certification that a device is not for an excluded purpose and requiring that a device not be included in the Register if it is for such a purpose, are to apply only to applications made after the day on which the instrument setting out the excluded purposes made under new section 41BEA takes effect.

 



SCHEDULE 3 - OTHER AMENDMENTS

 

This schedule contains a number of miscellaneous amendments intended to improve the operation of the Act, enable optimal administrative practice, encourage accuracy in advertising and clarify the legislative framework for required advisory statements on specified medicine labels.

 

Part 1 - Amendments commencing on day after Royal Assent

 

Items 1, 3 and 4

Item 1 inserts a new definition of genetically modified organism in subsection 3(1) of the Act.  The definition refers to that given in the Gene Technology Act 2000 .  This definition will be in addition to that of genetically modified product under section 3(1) of the Act, which also refers to the definition given in the Gene Technology Act 2000 .

 

Item 3 inserts the words “or a genetically modified organism” to section 30C(1).  This will enable the Secretary to consult with, and to seek advice from, the Gene Technology Regulator in regard to applications for the listing or registration of therapeutic goods (other than medical devices) that are, or contain, a genetically modified product or a genetically modified organism.

 

Item 4 replaces subsection 30D(1) to enable that section to apply to genetically modified organisms in addition to genetically modified products.  As a result, the Secretary will be empowered to request advice from the Gene Technology Regulator in relation to therapeutic goods (other than medical devices) that consist of, or contain, a genetically modified product or genetically modified organism that belongs to a class specified by the Secretary in the request.

 

To reflect the amendment made by item 4, the heading of section 30D will be altered by including reference to genetically modified organisms so the heading will read ‘Secretary may seek advice about classes of GM products or genetically modified organisms’.

 

These amendments anticipate the potential that a therapeutic good, such as a medicine, may include a genetically modified organism and that consultation with the Gene Technology Regulator would be appropriate to ensure safety, quality and efficacy in relation to the product, including its manufacture, handling and supply.

 

Items 2 and 5

These items make amendments to the offence provisions for inappropriate advertising of therapeutic goods (other than medical devices) and medical devices.

 

Item 2 repeals subsection 22(5) and substitutes it with a new subsection 22(5) which has the effect of expanding the current offence provision to cover any person inappropriately advertising a therapeutic good (other than medical devices), not only the sponsor.  It provides that a person commits an offence if they advertise, by any means, therapeutic goods that are included in the Register for an indication that is not the indication accepted for its inclusion in the Register.

 

This is necessary to ensure appropriate information is provided to the public to support safe, effective and correct use of therapeutic goods.  The amendment will also prevent a sponsor requesting that another person advertise their therapeutic good on their behalf for an indication for which the good has not been shown to be safe and effective.

 

Item 5 replaces section 41ML which provides an offence for false advertising about medical devices.  The amendment clarifies the existing provision to make it consistent with that provided under new subsection 22(5) for other therapeutic goods.  The scope of section 41ML now covers any person who falsely advertises a kind of medical device that is included in the Register and the purpose for which it is advertised is not a purpose accepted in relation to that inclusion.

 

In view of the seriousness of the offence of false advertising, both new subsection 22(5) and new section 41ML continue to be strict liability offence provisions and will continue to attracting a penalty of 60 penalty units (i.e. presently $6,600).

 

Item 6

This item replaces paragraph 57(8)(b) relating to delegation of the powers of the Secretary under section 19A.  The amendment provides that these powers may be delegated to a person who holds, occupies or performs the duties of a position in the Therapeutic Goods Administration (TGA) that is prescribed in the regulations for the purposes of this paragraph.

 

This will enable the delegated position to be set out in regulations, removing the reference in the Act to a particular branch of the TGA, because this may change as the administrative structures within the TGA evolve.  Although the delegation provision will now be set out in the regulations, it is intended that only officers holding SES Band 1 positions or equivalent and other higher position will be accorded delegation of the powers of the Secretary under section 19A.

 

Item 7

Subitem (1) provides that the amendments made by items 2 and 5, relating to offences for false advertising of therapeutic goods and kinds of medical devices, apply in relation to advertisements occurring on or after the day after the Act receives Royal Assent.

 

Subitem (2) provides that the amendment made by item 3, relating to consultation with the Gene Technology Regulator, applies in relation to applications for the registration or listing of therapeutic goods that consist of, or contain, genetically modified organisms made on or after the day after the Act receives Royal Assent.

 

Subitem (3) explains that the validity of a request made under subsection 30D(1) of the Act before the day after the Act receives Royal Assent is not affected by the amendment made by item 4, relating to seeking advice from the Gene Technology Regulator in regard to therapeutic goods that consist of, or contain, genetically modified organisms.

 

Part 2 - Amendments commencing on day to be fixed by Proclamation

 

Items 8 to 10

These items provide for certain medicines to be required to include advisory statements on the label to support the safe and effective use of the medicine by consumers.

 

Item 8 inserts new paragraph 3(5)(ca) in relation to acceptability of presentation of therapeutic goods.  The new paragraph specifies that the presentation of a therapeutic good is unacceptable if the good is a medicine included in a class of medicines specified in the regulations for the purposes of this paragraph, and the label does not contain the advisory statement(s) required for that medicine as specified under new subsection 3(5A) (item 9 refers).

 

The classes of medicines that the regulations would specify are generally those that are available without a prescription that a person would select on their own, or with the assistance of a pharmacist, by reference to the label.

 

Item 9 inserts two new subsections 3(5A) and 3(5B).  Subsection 3(5A) empowers the Minister to specify, by legislative instrument, advisory statements in relation to medicine for the purposes of new paragraph 3(5)(ca) (item 8 refers).

 

New subsection 3(5B) explains, to avoid doubt, that the instrument made under new subsection 3(5A) can specify different advisory statements for different medicines or different classes of medicines.

 

For example, the Minister may specify that different advisory statements are required to be included on the label of medicines for pain relief that contain paracetamol than those to be included on the label of medicines for pain relief that contain a non-steroidal anti-inflammatory ingredient.

 

Examples of advisory statements that may be specified by the Minister include:

·          ‘Do not use on broken skin;

·          ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate’;

·          ‘If symptoms persist beyond 5 days consult a doctor’.

 

Item 10

This item specifies that the amendment made by item 8, to enable the Minister to specify by legislative instrument advisory statements, applies to applications to register or list a medicine that has been made on or after proclamation of this Part.