Bills Digest no. 122 2008–09
Therapeutic Goods Amendment (2009 Measures No. 1) Bill
2009
WARNING:
This Digest was prepared for debate. It reflects the legislation as
introduced and does not canvass subsequent amendments. This Digest
does not have any official legal status. Other sources should be
consulted to determine the subsequent official status of the
Bill.
CONTENTS
Passage history
Purpose
Background
Financial implications
Main provisions
Concluding comments
Contact officer & copyright details
Passage history
Date
introduced: 19 March
2009
House: House of Representatives
Portfolio: Health and Ageing
Commencement:
Sections 1 to 3 and all
other provisions not listed in item 2 on Royal
Assent
Schedules 1, 3, and
6-7 (Part 1) the day after Royal Assent
Schedules 2, 5 and 7
(Part 2) a single day to be fixed by Proclamation, or six months
after Royal Assent, whichever is the earlier.
Schedule 4 1 July
2011.
Links: The
relevant links to the Bill, Explanatory Memorandum and second
reading speech can be accessed via BillsNet, which is at http://www.aph.gov.au/bills/.
When Bills have been passed they can be found at ComLaw, which is
at http://www.comlaw.gov.au/.
The Therapeutic Goods Amendment
(2009 Measures No. 1) Bill 2009 (the Bill) seeks to amend the
Therapeutic Goods Act 1989 (the Act) to:[1]
- allow registered or listed goods on the Australian Register of
Therapeutic Goods (the Register)[2] to be suspended in certain circumstances
- amend manufacturing licences to be issued for single sites
only, unless specifically exempted
- amend monitoring powers so as to allow the taking of samples of
any therapeutic goods, as well as anything relating to the
therapeutic goods on manufacturing premises, and to allow the
taking of any still or moving image or any recording
- amend arrangements for regulating homeopathic and
anthroposophic medicines[3]
- enable the making of lists of permissible and prohibited
ingredients in listed medicines
- clarify arrangements for the setting of conditions on
registered and listed goods, and
- make technical corrections to references to certain legislative
instruments to reflect changes in terminology.
These amendments are part of a package of
amendments to the Act announced by the Government in
2008.[4]
This Digest will particularly focus on the proposed changes to
the regulation of complementary medicines, which involves a
substantive change.
The Therapeutic Goods Administration (TGA), an agency of the
Commonwealth Department of Health and Ageing (DoHA), is the
principal regulator of therapeutic goods in Australia. Before a
product can be marketed[5] in Australia, it must be registered in the Register. For
therapeutic goods such as medicines and medical devices, the TGA
makes an assessment of the quality, safety and efficacy of the
product. The TGA also has a
post-marketing surveillance role and monitors adverse reactions to
therapeutic goods. It operates on principles of risk management,
balancing the maintenance of public health and safety with reducing
unnecessary regulatory burden.[6]
The Act and the Therapeutic Goods Administration Regulation
1990 (the Regulations) are the primary means by which
therapeutic goods and medical devices are regulated in
Australia.[7]
The objects of the Act are to provide for the establishment and
maintenance of a national system of controls relating to the
quality, safety, efficacy and timely availability of therapeutic
goods that are used in Australia or exported from Australia. The
TGA is responsible for administering the provisions of the Act.
A complementary medicine is a therapeutic good consisting wholly
or principally of one or more designated active ingredients, each
of which has a clearly established identity and a traditional use.
Traditional use means use of the designated active ingredient that
is well documented, or otherwise established, according to the
accumulated experience of many traditional healthcare practitioners
over an extended period; and accords with well-established
procedures of preparation, application and dosage.[8]
As previously mentioned, complementary medicines must be
registered on the Register before they can be marketed in
Australia. The Australian regulatory
guidelines for complementary medicines[9] outlines the regulatory process of
complementary medicines, of which there are five phases:
- pre-assessment (brief review of application by TGA i.e. to
ensure that key data has been provided)
- evaluation and peer review
- consideration by the Complementary Medicines Evaluation
Committee[10] and a
recommendation is made to the TGA
- decision by a delegate of the Secretary of DoHA, and
- implementation (if successful).
An assessment is made on the quality of the product, especially
the active ingredients and its excipients.[11] The manufacturing process and level
of Good Manufacturing Process (GMP), as well as details of quality
control processes to ensure consistency, are also assessed by the
TGA.
The sponsor is obliged to provide evidence of efficacy, which is
reviewed by the TGA. This is a paper based assessment only and the
TGA does not conduct any testing of complementary medicines. The
safety of the product may be established by reliance on published
data or with reference to existing literature. In vitro
studies are not required. The therapeutic claims of the product are
also reviewed to ensure that there is sufficient supporting
evidence.
Basis of policy commitment
As mentioned above, the Government
has commenced a reform agenda to update and streamline the existing
regulatory framework for all therapeutic goods in Australia. These
reforms largely reflect the wide range of regulatory reforms that
were developed and consulted on as part of the legislation
associated with the proposed
Australia New Zealand Therapeutic Products Authority (ANZTA),
which was abandoned in 2007.[12]
In general, the Government expects
that the proposed amendments will improve the efficiency of the
operation of the TGA and strengthen the regulatory framework for
complementary medicines.[13] The proposed amendments also reflect recommendations
that were made in the 2003 Report to the Parliamentary Secretary to
the Minister for Health and Ageing, the Hon. Trish Worth MP, by the
Expert Committee on Complementary Medicines in the Health System
(the Report)[14]
regarding the regulation of homoeopathic medicines and related
remedies. The Report was in response to the Pan Pharmaceuticals
recall in 2003.[15]
In short, recommendation 2.1.8 of the Report recommended that
homoeopathic and related remedies that make therapeutic claims
should be regulated to ensure that they meet appropriate standards
of safety and quality.[16] The Report noted that the definition of homeopathic
preparation should be amended to reflect only preparations that are
made with ingredients consistent with homoeopathic principles and
practices.[17]
Prior to the legislation being tabled in Parliament, the TGA
conducted a series of public consultation sessions which outlined
the reform directions and proposed legislative amendments.[18] It was noted that the
proposed legislative amendments would provide clarification on the
appropriate standard for homoeopathic and anthroposphic
preparations and make administrative changes. These have been
reflected in Schedule 4.
On 19 March 2009, the Senate Selection
of Bills Committee resolved that the Bill not be referred to
committees.[19]
Position of
significant stakeholders
The Complementary Healthcare Council (CHC) of Australia has long
supported the existing regulatory framework for complementary
medicines, arguing that that it is world class .[20] Although there has been no
specific commentary on the proposed amendments, the CHC has
previously argued against calls for a stronger regulatory framework
for complementary medicines.[21]
When the ANZTPA formally disbanded, the CHC expressed
disappointment that the joint regulatory agency was not being
established but advocated that many of the proposed changes to the
regulatory framework for complementary medicines should be
implemented.[22]
This is consistent with the public consultation documents released
by the TGA indicating widespread stakeholder support for many of
the changes to be implemented in the context of ANZTPA.
The Australian Self Medication Industry (ASMI) has also
expressed support for the complementary medicine regulatory
framework as it currently stands.[23] Like the CHC, ASMI supported the proposed changes
that were due to be implemented in the context of ANZTPA for
complementary medicines to still go ahead.[24]
Although there has been no explicit statement of support for the
proposed amendments, it could be inferred that there is general
support from stakeholders as the legislation largely reflects what
had previously been agreed to in the context of ANZTPA.[25]
The Government states that the amendments proposed in the Bill
will not have any financial impact on the Commonwealth, and will
have, at most, a low impact on the therapeutic goods
industry.[26]
Schedules 1 to 7 of the Bill
propose amendments in relation to matters including:
- suspension of registered and listed goods from the
Register
- manufacturing licenses
- monitoring powers
- homeopathic and anthroposophic medicines
- therapeutic goods ingredients, and
- miscellaneous amendments, including conditions on therapeutic
goods.
The Act already allows for medical devices to be suspended from
the Register in certain circumstances, including where it is
considered that remedial action can be taken to address the grounds
of suspension. However, this is not the case with respect to
therapeutic goods. Amendments in Schedule 1 of the
Bill seek to address this anomaly. Examples of such proposed
amendments are as follows.
Item 2 of Schedule 1 of the
Bill proposes to insert new sections 29D -29G into
Part 3.2 of Chapter 3 of the Act (registration and listing of
therapeutic goods).
Under proposed subsection 29D(1), the
Secretary[27] would
have a discretionary power to suspend the registration or listing
of therapeutic goods if satisfied that:
- either:
- if the goods remain on the Register, there is a potential risk
of death, serious illness or serious injury, and
- within the suspension period, the person concerned is likely to
be able to take the necessary action to ensure, if the therapeutic
goods were to remain on the Register, those goods would not cause a
potential risk of death, serious illness or serious injury, or
- it is likely that there are grounds for cancelling the
registration or listing of the goods in particular
circumstances.[28]
Where it is likely that there are grounds for
cancelling the registration or listing of the goods in particular
circumstances under proposed paragraph 29D(1)(b),
proposed subsection 29D(2) would require the
Secretary to provide written notice to the person in relation to
whom the therapeutic goods are included in the Register, of the
Secretary s intention to suspend and reasons for doing so, as well
as to afford that person a reasonable opportunity to make
submissions in relation to the proposed suspension of goods.
Under proposed subsection
29D(3), the Secretary must not make any final decision
about suspension of goods until he or she has considered any such
submissions.
Under proposed subsection
29D(4), a notice of suspension must specify the period of
suspension, which must not exceed six months.
Proposed section 29E provides
for when any suspension would become effective and extension of
suspensions.
Notably, under proposed paragraph
29E(1)(a), if the suspension is necessary to prevent a
potential risk of death, serious illness or serious injury,
suspension takes effect on the day on which notice is given to the
person. In any other case, under proposed paragraph
29E(1)(b), suspension becomes effective on a day that is
20 days or later after the notice is given to the person, as
specified in the notice itself.
A suspension is effective until the Secretary
revokes it under proposed section 29F
(proposed paragraph 29E(2)(a)) or at the
expiration of either:
- the specified period of suspension under proposed
subsection 29D(4), or
- the specified period (if any) for which suspension is extended
under proposed subsection 29E(3) (proposed
paragraph 29E(2)(b)).
Suspensions may, by written notice to the person
concerned, be extended for a period of not more than six months
(proposed subsection 29E(3)) or revoked
(proposed section 29F).
Under proposed subsection
29F(1), if the Secretary is satisfied that:
- the ground(s) upon which the registration or listing of the
therapeutic goods were suspended no longer apply, and
- there are no other grounds upon which to suspend the
registration or listing of those goods,
the Secretary must revoke the suspension
by written notice to the person concerned.
However, under proposed subsection
29F(2), if the person concerned applies in writing or at
the Secretary s own initiative, the Secretary may revoke
the suspension.
If, after the person concerned makes an
application for the suspension to be revoked, the Secretary decides
not to do so, the Secretary must provide the person with
written notice of that decision and the reasons for it
(proposed subsection 29F(4)).
It is noted that, in relation to decisions to
suspend and to revoke suspension, there are requirements for
publication of particulars of those decisions in the Government
Gazette[29]
(proposed subsections 29D(5) and
29F(3)).
It is noted that the Secretary s decisions made
under those proposed amendments would be reviewable by the Minister
at first instance and that the Minister s decision would be
reviewable by the Administrative Appeals Tribunal (the AAT) under
section 60 of the Act.
The Act requires a person who manufactures therapeutic goods
(not medical devices) to hold a manufacturing licence, subject to
certain exceptions.[30] The TGA may currently issue such a licence authorising
the manufacture of therapeutic goods at more than one
premise.[31]
Amendments proposed in Schedule 2 seek to ensure
that a manufacturing licence only applies to one site, unless
otherwise allowed in guidelines that the Secretary determines.
Examples of such proposed amendments are as follows.
Item 5 of Schedule 2 of the
Bill proposes to insert new subsections 37(1A) and
37(1B) into the Act.
Under proposed subsection 37(1A), a
manufacturing licence application must generally relate to only one
manufacturing site.[32]
However, proposed subsection 37(1B) provides
that if, after considering guidelines that would be developed under
proposed section 38A,[33] an applicant believes that a licence
could be granted covering two or more manufacturing sites, that
applicant may identify those sites in the manufacturing licence
application and state his or her reasons for doing so.
Item 11 of Schedule 2 of the
Bill proposes to insert new subsections 38(2A) and
38(2B) into the Act. Section 38 of the Act sets
out certain matters for the Secretary s consideration when deciding
whether to grant a manufacturing licence.
Under proposed subsection 38(2A), the Secretary
must consider the guidelines that would be developed under
proposed section 38A[34] when granting manufacturing
licences.
Under proposed subsection 38(2B), the Secretary
must, in the licence itself, authorise the specific
licence holder to carry out particular steps in the manufacture of
specified therapeutic goods at each manufacturing site covered by
the licence.
Item 12 of Schedule 2 of the
Bill proposes to insert new sections 38A and
38B into the Act.
Proposed section 38A provides that the
Secretary must make guidelines that set out when a licence
may cover two or more sites and that such guidelines be made by
legislative instrument.
Proposed section 38B provides for converting
old licences covering two or more sites into new licences that
comply with the proposed requirements by revoking the old licence
and granting new licences that together cover all of the sites
under the old licence. There would be no charges for the new
licences issued (proposed subsection 38B(10)).
Notably, decisions to revoke the old licence would not be subject
to review under section 60 of the Act (proposed subsection
38B(11)). However, this is not expected to be problematic
as the new licences would cover all sites under the old licence and
no proprietal rights would be extinguished.
Item 19 of Schedule 2 of the
Bill proposes to insert new sections 40A and
40B into the Act.
Under proposed subsection 40A(1), the Secretary
has a discretion as to whether to vary a manufacturing site
authorisation in relation to a manufacturing licence, at his or her
own initiative and by written notice to the licence holder.
Under proposed paragraph 40A(2)(a), if the
notice states that the variation is necessary to prevent imminent
risk of death, serious illness or serious injury, the variation
becomes effective on the day that the notice is given to the
licence holder. Otherwise, under proposed paragraph
40A(2)(b), the variation becomes effective on the day
specified in the notice but no earlier than 28 days after the
notice is given to the licence holder.
Proposed subsection 40B(1) provides that the
licence holder may apply to the Secretary for a variation of the
manufacturing licence to cover additional manufacturing sites if
the licence holder, after considering guidelines that would be
developed under proposed section 38A,[35] believes that the
licence could cover the additional sites. Such applications are
subject to certain requirements provided for under proposed
subsection 40B(2). Where such an application is made and
accompanied by any prescribed inspection fee, the Secretary
may vary the licence accordingly by written notice to the
licence holder (proposed subsection 40B(3)).
However, where the Secretary exercises such discretion, he or she
must, in such notice, vary the licence to authorise the
licence holder to carry out particular steps in manufacturing
specified therapeutic goods at each additional manufacturing site
(proposed subsection 40B(4)). Variations would
become effective on the day that the notice is given to the notice
holder (proposed subsection 40B(5)).
It is noted that the Secretary s decisions made
under those proposed amendments would also be reviewable by the
Minister at first instance and that the Minister s decision would
be reviewable by the AAT under section 60 of the Act.
Licence holders may also apply for a variation of a
manufacturing site authorisation[36] relating to a manufacturing licence.
In addition, Schedule 2 contains amendments to
the Act providing for transfer of licences where particular
circumstances change, such as a change in ownership of the
manufacturing operations.
For example, item 21 of Schedule
2 of the Bill proposes to insert new section
41AAA into the Act, which provides that the
Therapeutic Goods Regulations 1990 (the Regulations) may
provide for the transfer of manufacturing licences, including:
- applications for transfer
- application fees
- assessment of applications
- conditions of transfer on licences, and
- review of decisions made under the Regulations.
The Act already contains provisions enabling authorised persons
( TGA inspectors ) under the Act to enter and inspect manufacturing
premises[37] and to
take samples of therapeutic goods while at those premises.[38] The Government states
that the current provisions are outdated and inconsistent.[39] Amendments to
monitoring powers under the Act are primarily proposed in
Schedule 3 of the Bill and seek to, as their
general purpose, make monitoring compliance under the Act more
consistent.
In general, while on premises, TGA inspectors would be able
to:
- inspect those premises and therapeutic goods/medical devices on
those premises, and
- examine, measure, take and conduct tests on and take samples of
any therapeutic goods/medical devices on those premises or anything
on those premises relating to any therapeutic goods/medical
devices.[40]
In addition, while on premises, inspectors would be able to take
still or moving images; or recordings, of those premises or
anything on those premises.[41] The Act currently refers to taking photographs,
including video recordings, as well as making sketches of the
premises and anything on the premises.[42]
Schedule 4 of the Bill contains proposed
amendments to improve the regulatory framework for homeopathic and
anthroposopic medicines in Australia. Examples of proposed
amendments are as follows.
Item 9 of Schedule 4 of the
Bill proposes to insert new sections 3AA
(homeopathic preparations) and 3AB (anthroposophic
preparations) into the Act.
Proposed subsection 3AA(1) defines homeopathic
preparation as one that was manufactured from a mother substance
using procedures described in a homeopathic pharmacopoeia.[43] Mother substance
means:[44]
- an animal
- a plant
- an alga
- a fungus
- a micro-organism
- a mineral or mineral compound
- a chemical, or
- something obtained from any of the above.
Proposed subsections 3AA(3),
(4) and (5) would give the
Minister a discretionary power to, by legislative
instrument:[45]
- specify that particular publications and/or part thereof are
homeopathic pharmacopoeia
- exempt specified monographs in specified homeopathic
pharmacopoeia, and
- exempt specified statements in specified monographs in
specified homeopathic pharmacopoeia.
Proposed section 3AB provides similarly in
relation to anthroposophic preparations.
Item 12 of Schedule 4 of the
Bill proposes to insert new section 13A into the
Act, dealing with homeopathic and anthroposophic standards.
Examples of proposed amendments are as follows.
Item 3 of Schedule 5 of the
Bill proposes to insert new sections 26BB,
26BC, 26BD, and
26BE into the Act.
Proposed subsection 26BB(1) would give
discretionary power to the Minister in making a determination by
legislative instrument to specify:
- active ingredients relating to medicine, and
- permitted concentrations and/or total amounts of some or all of
those ingredients.
According to proposed section 26BC, the
Minister may also vary such a determination, also by legislative
instrument.
Proposed section 26BD would enable a person to
apply to the Minister for a variation of the Minister s
determination under proposed section 26BB.
Proposed section 26BD also provides for formal
requirements of such application; discretion by the Minister in
requesting further information from the applicant and in varying
the determination following proper application and payment of any
prescribed fee.
Proposed section 26BE provides for prohibited,
as well as limited components and/or ingredients relating to
therapeutic goods, as specified by the Minister in a determination
made by legislative instrument, which the Minister may vary.
Item 1 of Schedule 5 of the
Bill proposes to insert new paragraphs
26(1)(ea) and (eb) into the Act. Under
proposed paragraphs 26(1)(ea) and
(eb), the Secretary may refuse to list therapeutic
goods if the goods contain a component or ingredient that:
- is specified in the determination relating to prohibited
components and/or ingredients under proposed subsection
26BE(1), or
- exceeds the permitted concentration or total amount of that
component or ingredient under proposed subsection
26BE(2).
Item 2 of Schedule 5 of the
Bill proposes to insert new paragraphs
26A(2)(ca)-(cd) into the Act. Under
proposed paragraphs
26A(2)(ca)-(cd), a person wishing for
certain medicine to be listed, must certify that:
- if a determination under proposed section
26BB, in relation to permissible active ingredients,
applies to a medicine, that medicine only contains active
ingredients specified in that determination
- if a determination under proposed section
26BB, in relation to permissible active ingredients,
applies to a medicine and that determination also specifies
permitted concentrations or total amount of the active ingredient,
the active ingredient does not exceed the permitted concentration
or total amount
- if a determination under proposed subsection
26BE(1), in relation to prohibited components or
ingredients, applies to a medicine, such medicine does not contain
a component or ingredient that is specified in that determination,
and
- if a determination under proposed subsection
26BE(2), in relation to limited components or ingredients,
applies to a medicine and that determination also specifies
permitted concentrations or total amount of the component or
ingredient, the medicine must not contain the concentration or
total amount of the component or ingredient exceeding the permitted
levels.
Examples of proposed miscellaneous amendments in
Schedule 7 are as follows.
Item 3 of Part 1 of
Schedule 7 of the Bill proposes to insert
new section 7C into the Act. Proposed section
7C would enable the Secretary to use computer programs,
under his or her control, when making decisions. It is noted that
the proposed section would afford some level of protection when
this process is used if the Secretary substitutes a decision for an
initial decision made by using a computer program when the
Secretary is satisfied that the initial decision is incorrect, the
Secretary can only do so within 60 days of the initial decision
being made (proposed subsection 7C(4)).
Item 14 of Part 1 of
Schedule 7 of the Bill proposes to insert
new section 30A into the Act. Proposed section
30A would enable the Secretary to revoke any cancellation
of the registration or listing of therapeutic goods, which had been
requested under paragraph 30(1)(c) of the Act, on subsequent
written request by the person who had initially requested such
cancellation, as well as on payment of a prescribed application
fee. In addition, once a cancellation is revoked, the cancellation
is taken to have never occurred. The Government states that this
proposed amendment addresses a situation where a person in relation
to whom therapeutic goods are listed or registered has mistakenly
applied to the Secretary to cancel that registration or listing
under existing paragraph 30(1)(c) of the Act. Without
proposed section 30A, if the person actually
wishes to continue the registration or listing, he or she would
have to reapply all over again.
Item 30 of Part 2 of
Schedule 7 of the Bill proposes to replace
subsections 28(1) and (2) of the Act with
new subsections 28(1), (2),
(2A) and (2B) relating to
conditions to which the registration or listing of therapeutic
goods would be subject. Such conditions would be contained in a
determination made by the Minister by legislative instrument and
could be imposed on the registration or listing of therapeutic
goods by written notice to the person concerned.
Item 34 of Part 2 of
Schedule 7 of the Bill proposes to insert
new paragraphs 28(5)(aa) and (ab) into
the Act, relating to additional conditions to which the
registration or listing of therapeutic goods would be subject.
Under proposed paragraphs 28(5)(aa) and
(ab), these would include conditions relating
to:
- prohibition on supplying or exporting these goods after expiry
date for the goods, and
- advertising the subject goods for indications[46] only accepted in relation to
inclusion of those goods in the Register.
Item 36 of Part 2 of
Schedule 7 of the Bill proposes to insert
new subsections 28(5B) and (5C) into the
Act, also relating to an additional condition to which the listing
of medicine would be subject. Under proposed subsections
28(5B) and (5C), the additional condition
is that, unless the medicine is exempt under Part 3-3 of the Act,
each step of the medicine manufacturing process in Australia must
be carried out either by a holder of licence under Part 3-3 of the
Act or someone who is exempt under that Part. In addition, each
step of that manufacturing process carried out outside of Australia
must be certified under subsection 26A(3) or proposed
subsection 28A(2) (see below) of the Act.
Item 37 of Part 2 of
Schedule 7 of the Bill proposes to insert
new section 28A into the Act, which would provide for the
certification by the Secretary that manufacturing steps outside
Australia, in relation to a listed medicine, comply with acceptable
manufacturing and quality control procedures.
Concluding comments
Many of the amendments reflect recommendations made to
Government in 2003 and are administrative in nature.
It could be considered that
these amendments go some way in strengthening the regulatory
framework for complementary medicines in Australia and in providing
greater protection and information for consumers.
Members, Senators and Parliamentary staff can obtain further
information from the Parliamentary Library on (02) 6277
2503.
Rebecca de Boer
Sharon Scully
8 May 2009
Bills Digest Service
Parliamentary Library
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