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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.