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2004-2005-2006-2007
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
SENATE
THERAPEUTIC GOODS AMENDMENT BILL 2007
EXPLANATORY MEMORANDUM
(Circulated by authority of the Parliamentary Secretary to the Minister for
Health and Ageing, Senator the Hon Brett Mason)
THERAPEUTIC GOODS AMENDMENT BILL 2007
OUTLINE
The amendments provided for in this Bill substitute the existing requirement within
subsection 9B(2) of the Therapeutic Goods Act 1989 (the Act) for therapeutic device
sponsors to have their products entered in the Australian Register of Therapeutic Goods
(ARTG) as "included" medical devices by 4 October 2007 with a requirement to lodge an
effective application by 4 October 2007. These changes are necessary to allow many devices
currently marketed as "registered" and "listed" therapeutic devices in Australia that are
essential for patient treatment and for the ongoing provision of health care services to be
supplied beyond 4 October this year whilst under reassessment by the Therapeutic Goods
Administration (TGA) prior to entry in the register as "included" medical devices.
The new regulatory framework for "medical" devices is contained in Chapter 4 of the Act
and commenced to operate on 4 October 2002, with two transition periods. The transition
periods enable "therapeutic" devices currently "listed" or "registered" in the ARTG under the
old regulatory scheme, set out in Chapter 3 of the Act, to be entered in the ARTG as
"medical" devices under the new scheme (Chapter 4 of the Act) by either 4 October 2004 or
4 October 2007.
The first transition period, established through the operation of subsections 9B(1), 15A(5)
and 15A(6) of the Act, ended on 4 October 2004 and required sponsors of previously exempt
medical devices and some medical devices that were no longer excluded from the operation
of the Act to have their devices included in the ARTG.
The second transition period, established in subsection 9B(2) of the Act, ends on 4 October
2007. The current effect of subsection 9B(2) is that therapeutic devices "registered' or
`listed' in the ARTG under Chapter 3 of the Act, being therapeutic devices that are not
subject to the requirements of subsection 9B(1), will be taken to have been cancelled on the
fifth anniversary of the day on which Chapter 4 commenced (i.e. 4 October 2007) or, if
entered in the ARTG as an "included" medical device under Chapter 4 of the Act before that
date, the date on which the inclusion takes effect. The effect of cancelling the registration or
listing of a therapeutic device under Chapter 3 of the Act is to prevent the sponsor of those
therapeutic devices from continuing to market them to the general public.
Under the existing provisions, cancellation of the "registration" or "listing" of a device
pursuant to paragraph 9B(2)(a) applies not only to those products for which the sponsor has
made no attempt to transition to Chapter 4 but also products that are the subject of an
effective application undergoing review by the TGA but not completed at the time the second
transition period ends. The consequence of cancellation of the latter group of devices from
the Register will be a hiatus in commercial supply of those devices, leading to commercial
disadvantage for the sponsor and an interruption of access to important health care services
and treatments by consumers/patients and their practitioners.
The amendment provided for by this Bill is needed to allow continued supply of any
"registered" or "listed" device that is the subject of an outstanding, effective application for
inclusion in the Register (under Chapter 4 of the Act) or for a Conformity Assessment
certification (section 41EB of Chapter 4 of the Act) as at the fifth anniversary of the day on
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which Chapter 4 commenced, until such time as the TGA has completed its assessment of the
compliance of the device with the requirements set out under Chapter 4 of the Act.
The scope of the amendments covers devices for which an effective application under section
41EB of the Act for Conformity Assessment certification has been received by 4 October
2007 because of the importance of Conformity Assessment certification as a prerequisite for
an effective application for inclusion in the Register of those devices identified in Regulation
4.1 of the Therapeutic Goods (Medical Devices) Regulations 2002, which includes all
devices manufactured in Australia. The amendments also cover devices for which an
effective application has been made under section 41FC for entry in the ARTG under Chapter
4 of the Act.
Financial Impact Statement
The amendments to the Act have no significant financial impact.
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THERAPEUTIC GOODS AMENDMENT BILL 2007
NOTES ON CLAUSES
Clause 1: states that the short title of the legislation is the Therapeutic Goods Amendment
Act 2007.
Clause 2: sets the commencement date for the amendments set out in Schedule 1 as 3
October 2007. This is necessary to ensure the measures are effective by the time of the fifth
anniversary of the commencement of Chapter 4 of the Therapeutic Goods Act 1989 (the Act),
to allow ongoing supply of devices undergoing processing and evaluation at that time. If the
commencement date is retrospective, the retrospectivity will not disadvantage applicants and
will be beneficial to applicants whose applications are covered by item 2 or 3 of the table
contained within Item 1 of Schedule 1.
Clause 3: has the effect of amending the Act in the manner specified in Parts 1 and 2 of
Schedule 1.
Schedule 1 - Amendments
Part 1 - Therapeutic Goods Act 1989
Item 1: repeals subsection 9B(2) of the Act and substitutes two new subsections.
Subsection 9B(2): contains a tabulation of the times at which registrations and listings of
devices made previously under Chapter 3 of the Act are taken to be cancelled. The
circumstances cover applications for inclusion in the ARTG under Chapter 4 as well as
applications for Conformity Assessment certification as follows:
Item 1 relates to applications for inclusion in the ARTG (section 41FC of the Act)
that are made before 4 October 2007 and finally determined before 4 October 2007.
Item 2 relates to applications for Conformity Assessment certification (section 41EB
of the Act) that are made before 4 October 2007 but not finally determined before 4
October 2007.
Item 3 relates to applications for entry in the ARTG (section 41FC of the Act) that are
made before 4 October 2007 but not finally determined before 4 October 2007.
The times at which registration and listings are taken to be cancelled are expressed in terms
of when the application is "finally determined", to allow for the eventuality that decisions
made on applications may subsequently be the subject of an appeal process. The term
"finally determined" is defined in subsection 9B(2A).
For applications for Conformity Assessment certification (Item 2), the registration or listing
of the device under Chapter 3 of the Act will be taken to be cancelled 30 days after the
application is "finally determined". The reference to the 30 days reflects the need for a
deadline that places an obligation on the sponsor to proceed to submit an application to
include the device in the Register under Chapter 4 of the Act once the sponsor has obtained
the necessary Conformity Assessment certification, otherwise the device could remain on the
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Register indefinitely as a registered or listed therapeutic device under Chapter 3 and not be
included in the Register under Chapter 4 of the Act.
Subsection 9B(2A): defines "finally determined" to recognise that a decision made in
relation to an application for Conformity Assessment Certification, or an application for entry
of a device on the ARTG under Chapter 4, may not be the final decision until appeal
processes have been completed.
Item 2: is a consequential amendment arising from the substitution of section 9B(2) in Item 1
of Schedule 1. It repeals the note under the heading in Chapter 3 of the Act, to point out that
devices still transitioning as at 4 October 2007 (i.e. subject to ongoing evaluation of
applications for either Conformity Assessment certification or inclusion in the ARTG under
Chapter 4 as at 4 October 2007) continue to be subject to the provisions set out within
Chapter 3.
Item 3: is a consequential amendment arising from the substitution of section 9B(2) in Item 1
of Schedule 1. It repeals the note under the heading in Chapter 4 of the Act, to point out that
the Chapter will not apply, and Chapter 3 will continue to apply, to devices still transitioning
as at 4 October 2007 (i.e. subject to ongoing evaluation of applications for either Conformity
Assessment certification or inclusion in the ARTG under Chapter 4 as at 4 October 2007).
Part 2 - Other Acts
Therapeutic Goods Amendment Act (No. 1) 2006
Item 4: is a consequential amendment to repeal the commencement date, being 4 October
2007, for a provision under the Therapeutic Goods Amendment Act (No. 1) 2006. That
provision removes references to `listed goods that are therapeutic devices' under paragraphs
19D(3)(a) and (4)(a) of the Act. Repealing the commencement date is necessary because
registered or listed therapeutic devices will continue to be supplied after 4 October 2007
where a decision has not been made, or finally determined, by 4 October 2007 in relation to
an application for a conformity assessment certificate or an application to enter devices under
Chapter 4 of the Act that was lodged before 4 October 2007.
Item 5: is a consequential amendment to remove a heading that is no longer necessary
because the only item under that heading referring to `therapeutic devices' has been repealed
by this Bill.
Item 6: is a consequential amendment to repeal a provision contained in the Therapeutic
Goods Amendment Act (No. 1) 2006 that removes a reference to therapeutic devices in
section 19D of the Act.
Therapeutic Goods Amendment (Medical Devices) Act 2002
Item 7: is a consequential amendment to remove the commencement date for provisions
included in Schedule 2 of the Therapeutic Goods Amendment (Medical Devices) Act 2002.
The provisions contained in Schedule 2 of that amending Act would, on 4 October 2007,
repeal references to, or references relating to, "therapeutic devices" contained in the Act,
because on and after that date it was assumed that all registered and listed therapeutic devices
would have been cancelled from the ARTG and instead would be entered as "medical
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devices" under Chapter 4 of the Act, so that references to "therapeutic devices" would no
longer be necessary after 4 October 2007. However, because of the changes being made by
this Bill, these references to "therapeutic devices" need to be preserved until all therapeutic
devices have been entered in the ARTG as "medical devices" under Chapter 4 of the Act.
Item 8: is a consequential amendment that repeals Schedule 2 of the Therapeutic Goods
Amendment (Medical Devices) Act 2002 which contains provisions that would, on 4 October
2007, repeal references to, or references relating to, "therapeutic devices" contained in the
Act.
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