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2010-2011
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
THERAPEUTIC GOODS AMENDMENT (2011 MEASURES NO.1) BILL 2011
EXPLANATORY MEMORANDUM
(Circulated by authority of the Hon Catherine King MP, Parliamentary Secretary for
Health and Ageing)
THERAPEUTIC GOODS AMENDMENT (2011 MEASURES NO.1) BILL 2011
OUTLINE
The Therapeutic Goods Amendment (2011 Measures No.1) Bill 2011 (the Bill)
amends the Therapeutic Goods Act 1989 (the Act). The amendments include:
· amendments to section 9D of the Act and subsections 31(1B) and (1C) to
support the new streamlined procedures for the processing of prescription
medicines;
· changes in the way that evaluation fees for applications for registration of
prescription medicines are payable with the effect that an applicant will be
required to pay the entire evaluation fee up front (ie at the time that the
application is accepted for evaluation) but will be entitled to a refund of 25%
of that fee if the evaluation is not completed within the period prescribed by
the regulations; and
· transitional provisions providing for the removal of old standard conditions
when the first legislative instrument made under subsection 28(2) of the Act
takes effect and to enable the Minister, in an instrument made under
subsection 28(2), to provide that particular standard conditions only apply to
future entries of goods in the Australian Register of Therapeutic Goods.
Reforms of processes for the evaluation of prescription medicines
In a review of the evaluation process for prescription medicines, the Therapeutic
Goods Administration identified a number of areas of process improvement. New
streamlined business processes have been introduced as a result of this review.
The key elements of these streamlined processes and related initiatives are:
1. clearly articulated and detailed requirements for submissions and the associated
information dossier
2. sponsor lodgement of proposed submission details (via a Pre-submission
Planning Form) 2½ months prior to lodgement of the complete submission and
associated dossier
3. TGA scheduling of resources to handle submissions that have been
foreshadowed through the lodging of the Form
4. careful checking of the submission and associated dossier prior to acceptance of
the application for evaluation to ensure compliance with the application form
and Common Technical Document requirements
5. new business processes within TGA to manage workflow and queues effectively
6. consolidation by the TGA of regulatory questions to the sponsor to avoid
unnecessary steps in the evaluation process
7. requirements for sponsors to answer regulatory questions within a set period to
allow the new work processes to proceed within planned timeframes
8. publication of a summary of the regulatory decisions made in relation to
evaluation for new prescription medicines, or major variations to existing
prescription medicines, and
9. publication of Product Information and Consumer Medicines Information on the
TGA website.
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Some changes to the Act in support of these revised procedures were made by the
Therapeutic Goods Amendment (2010 Measures No.1) Act 2010. The Bill includes
further changes to give effect to other elements of the new processes. The Bill makes
amendments to section 9D of the Act in relation to requests under subsection 9D(3)
for changes to the entry of a prescription medicine where the request requires the
evaluation of clinical, pre-clinical or bioequivalence data (and which must, under the
regulations be decided within 175 or 255 working days, depending on the
circumstances). The effect of the amendments is that the request will not be effective
unless any prescribed application fee has been paid, the request is in accordance with
the relevant approved form, it contains the information required by the form and the
request is made in the manner required by the Secretary.
This amendment will assist in eliminating unnecessary delays by requiring that
requests to which these requirements apply contain all the information necessary in
order for a decision to be made on the request in a timely manner. It reflects
provisions already in place under section 23 of the Act in relation to applications for
new entries in the Register for prescription medicines.
The Bill also amends subsections 31(1B) and (1C) to refer to a "pre-submission
planning form". This terminology reflects the new processes for the assessment of
prescription medicines.
Refund of evaluation fees
Currently, a person who makes an application under section 23 of the Act to which an
evaluation period has been prescribed under paragraph 63(2)(da) is only required to
pay 75% of the evaluation fee when the application is accepted for evaluation. The
remaining 25% is only payable if the evaluation is completed within the prescribed
period. Under the regulations the period prescribed for the evaluation of applications
for new entries in the Register for prescription medicines is 175 or 255 working days,
depending on the circumstances.
The effect of the amendments made in the Bill to section 24D of the Act is that while
the whole amount of an evaluation fee is payable when the application is accepted for
evaluation, 25% will be refunded to the applicant if the evaluation is not completed
within the prescribed period. The amendments will ensure that all evaluation fees that
are required to be paid under the Act can be effectively and efficiently collected.
Amendments to standard conditions
The Therapeutic Goods Amendment (2009 Measures No.1) Act 2009 (the Amendment
Act) amended the Therapeutic Goods Act to enable a legislative instrument to be
made by the Minister under subsection 28(2) of the Act to set out the standard
conditions for the registration or listing of therapeutic goods. These are mainly
prescription, over-the-counter and complementary medicines and therapeutic devices.
The Secretary also has the power to impose additional conditions or vary or remove
existing conditions, on a case by case basis.
The Amendment Act included application provisions to the effect that the legislative
instrument will apply its "new" standard conditions to all registered and listed goods,
whether included in the Register before or after the instrument comes into effect. The
intention was that the Secretary would remove the "old" standard conditions applying
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to goods in the Register at the time the instrument comes into effect on a case-by-case
basis. The Bill includes amendments to provide that the old standard conditions cease
to apply when the first instrument made under subsection 28(2) takes effect making it
unnecessary for the Secretary to do so.
The Bill also includes amendments to enable the Minister, in an instrument made
under subsection 28(2), to provide that particular conditions only apply to goods
registered or listed after the instrument comes into effect.
FINANCIAL IMPACT STATEMENT
The amendments made by this Bill will have a nil financial impact on the
Commonwealth as the Therapeutic Goods Administration, which administers the Act,
operates on a cost recovery basis.
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THERAPEUTIC GOODS AMENDMENT (2011 MEASURES NO.1) BILL 2011
NOTES ON CLAUSES
Clause 1 - Short Title
This clause provides that the Bill, once enacted, may be cited as the Therapeutic
Goods Amendment (2011 Measures No.1) Act 2011.
Clause 2 - Commencement
This clause provides that the Bill will commence on Royal Assent.
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 applicable items in the Schedule concerned, and
any other item has effect according to its terms. Schedule 1 amends the Therapeutic
Goods Act 1989.
SCHEDULE 1 -- AMENDMENTS
Therapeutic Goods Act 1989
Item 1
This item repeals subsections 9D(6) to (8) and substitutes new subsections 9D(6) and
(7).
New subsection 9D(6) enables the Secretary, in writing, to approve a form for
particular kinds of requests under section 9D and to approve the manner for making
particular kinds of requests under section 9D.
New subsection 9D(7) provides that where the Secretary has approved a form for a
particular kind of request under section 9D and approved the manner of making such
a request, the request will not be effective unless the request is in accordance with that
form, it contains the information required by the form, is made in the manner required
by the Secretary and any prescribed application fee has been paid.
The requirements in new subsection 9D(7) will apply to requests under subsection
9D(3) which, under the regulations, must be decided within 175 or 255 working days,
depending on the circumstances. These are requests which involve the evaluation of
clinical, pre-clinical or bioequivalence data. The requirements will also apply to any
other kind of request that is prescribed for the purposes of new subparagraph
9D(7)(b)(ii).
Item 2
This item makes an amendment to subsection 24(2) which is consequential on the
amendments made to section 24D by item 4.
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Item 3
This item makes an amendment to section 24A which is consequential on the
amendments made to section 24D by item 4.
Item 4
This item repeals subsections 24D(2) to (6) and substitutes new subsections 24D(2)
and (3). The effect of current subsections 24D(2) to (6) is that the applicant for the
registration of a new entry in the Register in relation to a prescription medicine is only
required to pay 75% of the evaluation fee payable in relation to that application when
the application is accepted for evaluation. The remaining 25% is only payable if the
evaluation is completed within the period prescribed in regulations made under
paragraph 63(2)(da) of the Act. The period prescribed is 175 or 255 working days,
depending on the circumstances.
New subsection 24D(2) provides that where an applicant has paid the whole of an
evaluation fee and the evaluation has been completed but not within the prescribed
period, the applicant must be refunded the amount of 25% of the evaluation fee. An
applicant will not be entitled to a refund in cases where the applicant withdraws the
application before the evaluation is completed even if the prescribed period is passed.
New subsection 24D(3) says that an evaluation is taken to be completed for the
purposes of subsection (2) when the applicant is notified under subsection 25(4) of the
Act of the Secretary's decision on the evaluation.
Item 5
This item amends paragraphs 31(1B)(b) and (1C)(b) to omit the reference to pre-
submission forms and substitute the words with `pre-submission planning form'.
Paragraphs 31(1B)(b) and (1C)(b) deal with the time period within which a person
must provide information or documents requested by the Secretary in a notice under
subsection 31(1) where the application is covered by the new streamlined procedures
for the evaluation of prescription medicines. This amendment reflects the terminology
used for the new streamlined procedures.
Item 6
This item includes an application provision in relation to the amendments made by
this Bill. Item 6 provides:
· the amendments made by item 1, in relation to requests under section 9D of
the Act, applies to requests made on or after the commencement of that item;
· the amendments made by items 2 to 4, regarding the payment of evaluation
fees for certain kinds of medicines, applies in relation to applications made
under section 23 of the Act on or after the commencement of those items; and
· the amendment made by item 5, dealing with notices given by the Secretary
under subsection 31(1) of the Act in relation to applications covered by the
new revised business procedures, applies in relation to notices given on or
after the commencement of that item.
Item 7
This item includes a transitional provision to ensure that any forms approved under
subsection 9D(6) before the commencement of proposed paragraph 9D(6)(a) continue
in force after that commencement as if they were approved under paragraph 9D(6)(a).
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Item 8
This item includes transitional provisions in relation to legislative instruments made
under subsection 28(2) of the Act.
The Therapeutic Goods Amendment (2009) Measures No. 1) Act 2009 made changes
to section 28 of the Act in relation to the imposition of conditions on the registration
or listing of goods. Subsection 28(1) provides that the registration or listing of
therapeutic goods is subject to the conditions set out in a determination made under
subsection 28(2). Subsection 28(2) allows the Minister, by legislative instrument, to
make a determination setting out various kinds of conditions that apply generally to
therapeutic goods or classes of therapeutic goods. In addition to the conditions
contained in the instrument made under subsection 28(2), the Secretary has the power
to impose, on a case-by-case basis, further conditions on the registration or listing of
goods under subsection 28(2B). The Secretary may also, under subsection 28(3)
impose new conditions or vary or remove conditions imposed under subsection
28(2B).
The effect of item 57 in Schedule 7 of that Act is that any legislative instrument made
under the new subsection 28(2) and imposed under the new subsection 28(1) (the
"new" standard conditions) will apply to the registration or listing of therapeutic
goods occurring before, on or after the commencement of the item. The item also
preserves the conditions applying to goods already on the Register when the
instrument takes effect and treats them as if they had been imposed under subsection
28(2B) thus allowing the Secretary to vary or remove them on a case-by-case basis.
This item came into effect on 25 January 2010.
The intention is that the new standard conditions imposed by the Minister will apply
to all registered and listed goods, including those on the Register at the time that the
instrument comes into effect. In order to prevent an overlap with standard conditions
already in place ("old" standard conditions), the Secretary would, by notice in writing
given to the person in relation to whom the goods are registered or listed, remove the
old standard conditions on a case-by-case basis using subsection 28(3).
Subitem 8(1) changes the operation of item 57 of Schedule 7 by providing for the
termination of the old standard conditions when the first instrument made under
subsection 28(2) takes effect.
Subitem 8(1) applies to old standard conditions that are taken to have been made
under subsection 28(2B) by the operation of item 57(3) of Schedule 7 of the
Therapeutic Goods Amendment (2009) Measures No. 1) Act 2009 and also to old
standard conditions that were imposed by the Secretary under subsection 28(2B)
following the changes made to section 28 by the Therapeutic Goods Amendment
(2009) Measures No. 1) Act 2009.
The amendments made by this subitem will provide a more efficient process for
replacing old standard conditions than removing such conditions on a case-by-case
basis using subsection 28(3). The Secretary may still use subsection 28(3) to vary or
remove the conditions applying in relation to particular cases if required. The old
standard conditions that cease to be in force when an instrument under subsection
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28(2) takes effect as a result of this transitional provision will not revive if the
instrument is later revoked.
By reason of subitem 8(2), an instrument made under subsection 28(2) can provide
that specified conditions only apply to a class therapeutic goods that are registered or
listed after the instrument takes effect. This amendment will ensure that the Minister
has the power to determine that specified conditions only apply to the registration or
listing of a class goods after the relevant instrument takes effect where it is
appropriate to do so.
Subitem 8(3) provides a definition of "amending Act" and "principal Act" to aid
clarity. The amending Act is a reference to the Therapeutic Goods Amendment
(2009) Measures No. 1) Act 2009 and the principal Act is a reference to the
Therapeutic Goods Act 1989.
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