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2010 - 2011 - 2012 - 2013
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
THERAPEUTIC GOODS AMENDMENT (2013 MEASURES NO.1) BILL 2013
EXPLANATORY MEMORANDUM
(Circulated by authority of the Hon Catherine King MP, Parliamentary Secretary for
Health and Ageing)
THERAPEUTIC GOODS AMENDMENT (2013 MEASURES NO.1) BILL 2013
OUTLINE
The Therapeutic Goods Amendment (2013 Measures No.1) Bill 2013 (the Bill) makes
a number of amendments to the Therapeutic Goods Act 1989 (the Act). These
include:
amendments to the definition of ,,therapeutic goods in subsection 3(1) of the
Act to enable the Minister, by legislative instrument, to specify products that are
taken not to be therapeutic goods for the purposes of the Act;
a new provision enabling the Secretary to remove products from the Australian
Register of Therapeutic Goods (the Register) which are not, or are no longer,
therapeutic goods within the definition in the Act;
clarify the source of the power for the Secretary to approve product information
under section 25AA of the Act; and
a number of other minor amendments designed to ensure consistency in the way
the different classes of therapeutic goods are treated under the Act.
Goods taken to not be therapeutic goods
The definition of therapeutic goods in subsection 3(1) of the Act is very broad and
principally includes goods "that are represented in any way to be ... likely to be taken
to be (i) for therapeutic use". ,,Therapeutic use is defined in subsection 3(1) of the
Act to include "preventing, diagnosing, curing or alleviating a disease, ailment,
defect or injury in persons" and "influencing, inhibiting or modifying a physiological
process in persons".
The definition of ,,therapeutic goods in subsection 3(1) has the potential, depending
on how it is interpreted, to extend to a wide range of goods that may not have been
intended to be regulated under the Act, including clothing and household items. This
is particularly likely to be the case as health-related claims are increasingly being
made about a range of products.
Currently, however, while it is possible to exempt goods coming within the definition
of ,,therapeutic goods from various, discrete requirements under the Act (for example,
the requirement to be included in the Register), it is not possible to entirely exclude
such products from the regulatory scheme for therapeutic goods.
That scheme imposes substantial criminal and civil penalties for persons importing or
supplying goods that come within the definition of ,,therapeutic goods if those goods
are not included in the Register or are not otherwise exempt or approved (sections
19B and 19D of the Act refer). Inclusion in the Register requires those intending to
import or supply the goods to comply with various regulatory requirements including,
at a minimum, that the goods comply with all relevant standards, are manufactured
according to good manufacturing principles and are safe for the purposes of which
they are intended to be used. Application fees and annual charges are payable.
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It is important therefore that there is as much clarity as possible about which goods
are covered by the regulatory scheme, and for the Minister to consider whether
particular goods which may come within the definition are appropriate for regulation
under the Act.
Increasingly, health and wellbeing claims are being made in relation to a wide range
of products for which public health is not, or is unlikely to be, an issue, and where the
focus may be more one of consumer protection - for example, power band bracelets,
and mattresses which contain bacteria designed to reduce the effects of dust mites.
The definition may also cover products for which there may be sound and important
public policy reasons for excluding from the scope of the regulatory scheme under the
Act.
To allow for greater clarity and certainty, Schedule 3 of the Bill amends the Act to
allow the Minister to make a legislative instrument determining that goods are not to
be therapeutic goods for the purposes of the Act either generally or when used,
advertised, or presented for supply in a particular way. Such a determination would
be required to be tabled before Parliament and would be disallowable.
Removal of products from the Register that are not therapeutic goods
Schedule 3 also amends the Act to include a power for the Secretary to remove a
product from the Register if the product does not in fact meet, or no longer meets, the
definition of a therapeutic good in subsection 3(1) of the Act.
This will be important in particular for medicines listed in the Register under section
26A of the Act on the basis of certifications made by the applicant, where the
electronic listing process does not involve pre-market scrutiny by the Therapeutic
Goods Administration (TGA)) so there is not an opportunity to screen an application
to establish that the relevant goods come within the definition before they are
included in the Register. It will also allow the Secretary to remove a product that may
have come within the definition when it was included but no longer does so, for
instance where claims about its therapeutic use are no longer being made.
Product information amendments
There is currently a lack of clarity about the source of the Secretarys power to
approve product information (PI) for medicines accepted for registration. The
amendment in Schedule 5 of the Bill makes it clear that the Secretary may approve PI
under subsection 25AA(1), and under new subsection 25AA(1A) is obliged to notify
the sponsor of the medicine of the approved PI.
Other amendments
The Schedules make a number of other amendments to the Act, including:
providing that the Secretary may suspend or cancel the registration or listing of
therapeutic goods where the presentation of the goods is not acceptable or, in
the case of listed goods, is unacceptable;
providing that the Secretary may cancel the registration or listing of therapeutic
goods where a sponsor does not respond to a request from the Secretary under
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section 31 of the Act to provide specified information or documents about those
goods;
giving the Secretary the option of publishing information about various
regulatory decisions made under the Act (including suspension and cancellation
of goods from the Register) on the Departments website rather than in the
Gazette;
giving the Secretary the power to require in particular circumstances (for
instance where therapeutic goods have been suspended or cancelled from the
Register, or where the Secretary has come to the view that the safety, quality,
efficacy/performance, or presentation of therapeutic goods, is unacceptable), the
sponsor of those therapeutic goods to provide information about the goods to the
public or to a class of persons such as health care professionals or patients, and
to give to the Secretary information about persons to whom the goods have been
supplied;
modifying the definition of a kit in section 7B of the Act to encompass kits
containing (among other things) only one registered or listed therapeutic good,
or a biological combined with other items (provided they are for use as a unit);
and
introducing an offence where a sponsor provides information that is false or
misleading in a material particular in relation to a request under section 9D of
the Act for a variation to an entry on the Register.
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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STATEMENT OF COMPATIBILITY FOR A BILL THAT RAISES HUMAN
RIGHTS ISSUES
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny)
Act 2011
Therapeutic Goods Amendment (2013 Measures No.1) Bill 2013
This Bill is compatible with the human rights and freedoms recognised or declared in
the international instruments listed in section 3 of the Human Rights (Parliamentary
Scrutiny) Act 2011.
Overview of the Bill
This Bill amends the Therapeutic Goods Act 1989 (the Act) in relation to a range of
matters including:
providing the Minister with the power to make legislative instruments excluding
identified goods, or excluding identified goods if the goods are used, advertised or
presented for supply in a particular way, from the definition of ,,therapeutic
goods;
including an offence and a civil penalty provision for providing false or
misleading information in connection with a request to vary an existing entry in
the Register for a therapeutic good;
providing that the Secretary may cancel the registration or listing of therapeutic
goods where the presentation of the goods is not acceptable or, in the case of listed
goods, is unacceptable;
providing that the Secretary may cancel the registration or listing of therapeutic
goods where a sponsor does not respond to a request from the Secretary under
section 31 of the Act to provide specified information or documents about those
goods; and
clarifying the arrangements relating to the approval of product information (PI) for
medicines accepted for registration in the Register.
Human Rights implications
The Bill contains one measure that appears to engage article 14(1) of the International
Covenant on Civil and Political Rights (the ICCR). This measure (item 10 of
Schedule 5 of the Bill refers), removes the right to merits review by the Minister and,
subsequently, by the Administrative Appeals Tribunal (the AAT), in relation to a
decision of the Secretary to approve or vary PI for a medicine (subsections 25AA(1)
and (4) of the Act refer). However, judicial review remains available in relation to
these decisions.
The removal of merits review rights in these instances is considered to be necessary
because a decision to approve, or to approve a variation to, PI is an integral part of the
decision by the Secretary to register the medicine to which the PI relates or to approve
a variation to that medicines entry in the Register.
The Bill clarifies that the approval by the Secretary of PI for a medicine is a separate
decision to the Secretarys decision approving its registration (in the case of an
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application for registration under section 23 of the Act) or varying the medicines
entry in the Register (in the case of a request under section 9D of the Act by the
sponsor of a register medicine to vary the medicines entry in the Register). However,
in practice the PI is always reviewed at the same time as the application for
registration is evaluated or the request for a variation is being considered (see for
instance, paragraph 25(1)(da) of the Act).
The Secretary would not be expected to accept a medicine for registration (or make a
variation to a registered medicines entry) unless satisfied that the content of the PI
was correct and properly reflective of the circumstances in which the medicine was
considered suitable for registration (or continued registration) on the basis of its
quality, safety and efficacy for the purposes for which it is to be used (paragraphs
25(1)(d) and 9D(3)(c) of the Act refer).
A person whose interests are affected by a decision under the new subsection 25(3)
(see item 4 in Schedule 5 below) to register a medicine in relation to which PI must be
provided or by a decision by the Secretary under subsection 9D(1), (2) or (3) to vary
the entry in the Register of such a medicine, has a right to seek internal review of that
decision. As the PI approved by the Secretary will reflect the decision of the
registration or variation decision of the Secretary (which is amenable to review) any
concerns with the PI can effectively be addressed through a review of the registration
or variation decision.
The Bill also contains one measure that appears to engage article 14(2) of the ICCR.
This measure is the addition to the Act of an offence (at new subsection 9G(2)), which
sets out that it is an offence of strict liability for a person to make a statement that is
false or misleading in a material particular in or in connection with a request under
section 9D of the Act for a variation to an existing entry in the Register for therapeutic
goods, where use of the goods, if the goods were used, would be likely to result in
harm or injury to any person.
The maximum penalty for this offence is 2,000 penalty units, with no imprisonment.
This offence forms part of a tiered approach to conduct relating to the provision of
false or misleading information in relation to a request under section 9D of the Act.
Section 9D of the Act allows the Secretary to vary an entry for therapeutic goods on
the Register in certain circumstances, including at the request by the person in relation
to whom goods are on the Register.
Requests to vary an entry of goods on the Register can relate to a variety of matters,
including quite serious safety issues, such as adding a warning or a precaution to the
product information of a prescription medicine in connection with the use of the
medicine.
Requests may also involve the provision of significant amounts of data, such as (in the
case of prescription medicines) clinical, pre-clinical or bioequivalence data necessary
for the Secretary to determine whether statutory requirements set out in the applicable
subsections in section 9D (e.g. in subsection 9D(3) that the variation does not indicate
a reduction in the quality, safety or efficacy of the goods for the purposes for which
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they are to be used) are satisfied such that the requested variation should be made to
the entry.
The provision of false or misleading information that was material to a decision by the
Secretary to vary an entry in the Register under the section could potentially have
serious consequences for public health. Currently, however, the Act does not contain
any offence or civil penalty provisions relating to the provision of false or misleading
information in connection with a request under section 9D.
It is important to note that new subsection 9G(2) does not incorporate any
imprisonment element and the maximum penalty is capped at 2,000 penalty units.
This maximum penalty level reflects the seriousness of the conduct addressed by the
offence - i.e. this offence will only apply where (among other components) use of the
goods to which the relevant section 9D request relates would be likely to result in
harm or injury to a person.
The strict liability offence at new subsection 9G(2) forms part of the Acts tiered
approach to criminal offences, and replicates the same approach adopted throughout
the Act for the provision of false or misleading information, where that information is
relied upon to inform a range of regulatory actions. In so doing, it will serve an
important role in deterring and addressing conduct that could potentially endanger
public health.
Conclusion
As applicants and sponsors would retain a right to merits review in the circumstances
outlined above in relation to an application for registration or a request to vary an
existing entry in the Register, and as the option of judicial review remains, to the
extent that the Bill may limit article 14(1) of the ICCR, this limitation is reasonable,
necessary and proportionate. In relation to the addition of the strict liability offence
for making false or misleading statements in connection with a request under section
9D of the Act, this is also considered (for the reasons outlined above) to be a
reasonable, necessary and proportionate limitation.
The Hon Catherine King MP, Parliamentary Secretary for Health and Ageing
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THERAPEUTIC GOODS AMENDMENT (2013 MEASURES NO.1) BILL 2013
NOTES ON CLAUSES
Clause 1 - Short Title
This clause provides that the Bill, once enacted, may be cited as the Therapeutic
Goods Amendment (2013 Measures No.1) Act 2013.
Clause 2 - Commencement
This clause provides that sections 1-3, and Schedules 1-15, of the Bill will commence
on the day the Bill receives Royal Assent, and that Schedule 16 of the Bill will
commence on a single day to be fixed by Proclamation. However, if the
commencement of Schedule 16 is not proclaimed within the period of 6 months from
the date of Royal Assent, that Schedule will commence the day after the end of that 6
month period.
The amendments made by Schedule 16 will commence on a date to be fixed by
Proclamation in order to allow the appropriate forms to be approved by the Secretary
prior to that commencement.
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 in a Schedule to this Bill has effect according to its terms.
SCHEDULE 1 -- Advertising
Therapeutic Goods Act 1989
This Schedule contains amendments to the Act to put beyond doubt that in those
instances where regulatory action in relation to therapeutic goods is predicated on
whether or not the goods comply with advertising requirements, those requirements
include applicable provisions of the Therapeutic Goods Advertising Code, made by
the Minister under section 42BAA of the Act (the Code).
Items 1 and 2
These items amend subsection 25(1) of the Act to clarify one of the factors the
Secretary must take into account when evaluating an application to register
therapeutic goods in the Register. This relates to assessing the compliance of the
goods with advertising requirements.
Paragraph 25(1)(f) of the Act requires the Secretary to consider whether such goods
conform to an applicable standard, or to any requirements relating to advertising
applicable under Part 5-1 of the Act or the regulations.
The purpose of the amendment is to clarify that a reference to advertising
requirements includes a reference to the Code.
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These changes do not introduce any new requirements, but make it clearer that the
requirement to consider compliance with the Code is part of the process of evaluating
applications to register medicines and therapeutic devices in the Register.
Items 3 and 4
Under section 26 of the Act the Secretary must list therapeutic goods to which the
section applies unless satisfied that the goods do not meet various requirements
including those relating to advertising applicable under Part 5-1 of the Act or under
the regulations.
The purpose of the amendments in items 3 and 4 is to clarify that a reference to
advertising requirements includes a reference to the Code. These amendments do not
introduce any new requirements for applicants, but rather have the effect of making it
clear that applicable provisions of the Code must be complied with in relation to
goods listed under section 26 as well as any other applicable advertising requirements
set out in Part 5-1 of the Act or under the regulations.
Items 5 and 6
These items relate to therapeutic goods listed in the Register under s.26A of the Act,
where one of the matters in relation to which the applicant must certify is that the
medicine conforms to every requirement (if any) relating to advertising applicable
under Part 5-1 of the Act or under the regulations. Again, the amendments under both
these items clarify that a reference to advertising requirements includes a reference to
the Code. This is provided for in new paragraph 26A(2)(da).
Items 7, 17 and 21
These items make similar changes in relation to the Code to those outlined above in
relation to the cancellation without notice of registered or listed goods, biologicals and
medical devices for non-compliance with advertising requirements.
Currently under paragraph 30(1A)(c) of the Act the Secretary may, by notice in
writing, cancel the listing of medicines listed under section 26A (which includes
complementary medicines) if there is a serious breach, involving the medicine, of
applicable requirements relating to advertising under Part 5-1 of the Act or under the
regulations, and where the Secretary is satisfied that:
the breach is significant and
that, as a result of the breach, the presentation of the medicine is misleading to a
significant extent.
Item 7 amends paragraph 30(1A)(c) to make it clearer that the reference to a breach of
advertising requirements in paragraph 30(1A)(c), as a ground for cancelling a section
26A listed medicine from the Register, includes a reference to a breach of any
applicable provisions of the Code.
Item 17 makes an equivalent amendment to paragraph 32GA(1)(j) of the Act to
include a reference to applicable provisions of the Code in relation to the Secretarys
power to cancel without notice biologicals from the Register for a breach of
advertising requirements.
8
Item 21 makes an equivalent amendment to paragraph 41GL(h) of the Act to include a
reference to applicable provisions of the Code in relation to the Secretarys power to
cancel without notice the inclusion of a kind of medical device from the Register for a
breach of advertising requirements.
Item 8
Subsection 30(2) of the Act sets out the grounds for cancelling the registration or
listing of therapeutic goods in the Register in relation to which the Secretary must
give notice of an intention to do so and invite submissions from the sponsor. One of
these grounds is that the goods do not conform to a requirement relating to advertising
applicable to the goods under Part 5-1 of the Act or under the regulations.
As item 6 has inserted new paragraph 26A(2)(da) to clarify that advertising
requirements includes applicable provisions of the Code, this item makes a minor
consequential amendment to paragraph 30(2)(ba) of the Act to include a reference to
new paragraph 26A(2)(da), introduced to the Act by item 6.
Items 9 and 10
These items make equivalent amendments to those outlined above, in relation to the
Secretarys power to (with notice) cancel registered or listed goods from the Register
for non-compliance with advertising requirements.
Currently, under paragraph 30(2)(e) of the Act, the Secretary may, with notice, cancel
registered or listed goods from the Register if the goods do not comply with an
applicable standard or an advertising requirement applicable to the goods under Part
5-1 of the Act or the regulations.
Taken together, items 9 and 10 move the reference to advertising requirements from
paragraph 30(2)(e) to new paragraph 30(2)(ea), which then includes (consistent with
the above changes) a specific reference to applicable provisions of the Code.
Item 11
This item introduces a minor amendment to subsection 31(1) of the Act to bring it in
line with other provisions in the Act relating to the Secretarys powers to obtain
information about therapeutic goods that are the subject of an application to include
them in the Register, or about goods that are, or that were at any time in the previous
5 years, included in the Register. The Secretarys information gathering powers in the
Act applying to registered and listed goods are replicated for biologicals (section
32JA of the Act refers) and medical devices (section 41JA of the Act refers).
Subsection 31(1) of the Act permits the Secretary to require a range of persons to give
information or documents about specified matters relating to registered therapeutic
goods, or goods the subject of an application for registration on the Register. These
persons include persons in relation to whom therapeutic goods are, or were at any
time in the previous 5 years, registered, and applicants seeking to register their goods
in the Register.
In contrast to the situation with listed goods, biologicals and medical devices,
subsection 31(1) of the Act does not currently provide for the Secretary to require
information or documents from sponsors or former sponsors about the conformity of
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registered goods with applicable standards. As failure to comply with applicable
standards is a ground for cancellation for registered goods (paragraph 30(2)(e) of the
Act refers), the Secretary may well need such information from the sponsor to
facilitate consideration of whether the goods should remain in the Register.
Item 11 includes new paragraph 31(1)(gb) in the Act to enable the Secretary to require
a sponsor to provide information about the conformity of registered goods to a
standard applicable to the goods.
This brings the Secretarys powers to require information or documents about
compliance with applicable standards for registered goods in line with the Secretarys
powers to obtain the same information about listed goods under subsection 31(2) of
the Act, and also with comparable provisions relating to other classes of therapeutic
goods i.e. biologicals and medical devices.
Items 12, 13, 14, 19 and 23
These items make equivalent amendments to the above changes relating to advertising
in relation to the Secretarys powers to obtain information and documents about
advertising compliance in relation to therapeutic goods.
Currently under paragraph 31(1)(h) of the Act, the Secretary may require information
or documents from persons mentioned in item 11 about the conformity of registered,
or registrable, goods to a requirement relating to advertising applicable under Part 5-1
of the Act or the regulations.
Item 12 substitutes this with a new paragraph 31(1)(h) to make it clear that the
Secretary may require information or documents about compliance with applicable
provisions of the Code when seeking information about compliance of the goods with
advertising requirements.
Similarly, in describing the Secretarys powers to obtain information about
compliance with advertising requirements for listable or listed goods, items 13 and 14
replace the reference to "a requirement relating to advertising applicable to the goods
under Part 5-1 or under the regulations" with a specific reference to an applicable
provision of the Code and any other requirement relating to advertising applicable
under Part 5-1 of the Act or under the regulations.
Item 19 makes an equivalent amendment to the information gathering powers of the
Secretary in relation to biologicals under paragraph 32JA(1)(m) of the Act, to clarify
that the Secretarys power to require information or documents about the compliance
of biologicals with applicable advertising requirements includes information about
compliance with applicable provisions of the Code.
Similarly, item 23 makes an equivalent amendment to paragraph 41JA(1)(h) of the
Act to clarify that the Secretarys ability to require information or documents about
the compliance of medical devices with advertising requirements includes the ability
to obtain details about compliance with applicable provisions of the Code.
10
Items 15 and 20
When applicants apply to include biologicals or medical devices in the Register, they
are required to certify, among other things, that their products comply with applicable
advertising requirements. These items make equivalent amendments to the above in
relation to references to complying with advertising requirements by including a
specific reference to compliance with applicable provisions of the Code.
To this end, item 15 introduces (for biologicals) a new paragraph 32DA(3)(d), which,
consistent with the above changes, includes a specific reference to the Code, and item
20 makes an equivalent amendment to section 41FD of the Act in relation to kinds of
medical devices, introducing a new paragraph 41JA(1)(h) which includes a specific
reference to the Code.
Item 16
Currently under paragraph 32DE(1)(d) of the Act, one of the matters to which the
Secretary must have regard when evaluating biologicals for inclusion in the Register
is whether the biological complies with every requirement (if any) relating to
advertising applicable under Part 5-1 of the Act or under the regulations.
Item 16 introduces a new paragraph 32DE(1)(d) which, consistent with the
amendments in Schedule 2, includes a specific reference to compliance with
applicable provisions of the Code.
Items 17 and 18
These items amend the Secretarys power to cancel a biological from the Register,
with notice, for non-compliance with advertising requirements.
Under paragraphs 32GA(1)(j) and 32GC(1)(g) of the Act, the Secretary may, in the
circumstances described under those provisions, cancel a biological from the Register
if it does not comply with an advertising requirement applicable under Part 5-1 of the
Act or the regulations.
Consistent with the changes made to other provisions in this Schedule, items 17 and
18 replace these paragraphs with new paragraphs 32GA(1)(j) and 32GC(1)(g) which
include a specific reference to compliance with applicable provisions of the Code.
Items 21 and 22
Subsections 41GL(1) and 41GN(1) of the Act list the circumstances in which the
Secretary may cancel a kind of medical device from the Register.
These circumstances do not currently include a reference to non-compliance with
advertising requirements notwithstanding that applicants seeking to include their
medical devices in the Register must certify compliance with advertising requirements
(paragraph 41FD(h) of the Act refers), and the Secretary has the power to obtain
information concerning compliance with this requirement (paragraph 41JA(1)(h) of
the Act refers).
Items 21 and 22 respectively amend paragraph 41GL(h) and add a new paragraph
41GN(1)(g) to the Act, to provide that the Secretary can cancel a kind of medical
device from the Register where it does not comply with an applicable provision of the
11
Code, or any other advertising requirement applicable to it under Part 5-1 of the Act
or under the regulations.
This amendment will mean that the Secretary will be able to issue a notice to cancel
or a proposal to cancel a kind of device from the Register in the event of a breach of
advertising requirements, including a breach of an applicable provision of the Code.
Application
Item 24 - medicines and therapeutic devices
This item describes how the changes made under the various items in this Schedule in
relation to registered or listed therapeutic goods will operate in relation to such goods.
Sub-items (1) - (3) provide, respectively, that the amendments to sections 25, 26 and
26A of the Act made by items 1-6 apply in relation to applications for registration or
listing made on or after the commencement of item 24.
Sub-item (4) provides that the amendments to subsection 30(1A) of the Act (relating
to cancellations without notice of goods from the Register) made by item 7 apply in
relation to cancellations made under subsection 30(1A) on or after the commencement
of item 24, whether the breach to which the notice relates occurs before or after that
commencement.
Sub-item (5) provides that the amendments to subsection 30(2) of the Act
(cancellations of goods from the Register with notice) made by item 8 apply in
relation to a proposal to cancel of which a person is informed under subsection 30(3)
of the Act on or after the commencement of item 24, whether the circumstances
giving rise to the proposed cancellation occurred or occur before or after that
commencement.
Sub-item (6) provides that the amendments to section 31 of the Act made by items
11-14 apply in relation to notices given by the Secretary under section 31 on or after
the commencement of item 24. This is the case whether (for a notice given to an
applicant for registration or listing) the application is made before or after that
commencement and whether (for a notice given to a person in relation to whom goods
are, or were at any time in the previous 5 years, registered or listed) the goods were
registered or listed before or after that commencement.
Item 25 - biologicals
This item sets out how the amendments made to various items in this Schedule that
relate to biologicals will operate.
Sub-item (1) provides that the amendments to section 32DA of the Act made by item
15 apply in relation to applications for the inclusion of a biological in the Register
made on or after the commencement of item 25.
Sub-item (2) provides that the amendments to section 32DE of the Act made by item
16 apply in relation to applications for the inclusion of a biological other than a Class
1 biological in the Register made on or after the commencement of item 25.
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Sub-item (3) provides that the amendments to subsection 32GA(1) of the Act made by
item 17 apply in relation to notices of cancellation given by the Secretary under
subsection 32GA(1) on or after the commencement of item 25, whether the breach to
which the notice relates occurs before or after that commencement.
Sub-item (4) provides that the amendments to subsection 32GC(1) of the Act made by
item 18 apply in relation to proposed cancellations of which a person is informed
under subsection 32GC(2) of the Act on or after the commencement of item 25,
whether the reason for the proposed cancellation occurs before or after that
commencement.
Sub-item (5) provides that the amendments to section 32JA of the Act made by item
19 apply in relation to notices given under section 32JA on or after the
commencement of item 25. This is the case whether (for a notice given to an
applicant for the inclusion of a biological in the Register) the application is made
before or after that commencement and whether (for a notice given to a sponsor of a
biological that is or was at any time in the previous 5 years included in the Register)
the biological was included in the Register before or after that commencement.
Item 26 - medical devices
This item sets out how the amendments to various items in this Schedule that relate to
medical devices will operate.
Sub-item (1) provides that the amendments to section 41FD of the Act made by item
20 apply in relation to applications for the inclusion of a kind of medical device in the
Register made on or after the commencement of item 26.
Sub-item (2) provides that the amendments to section 41GL of the Act made by item
21 apply in relation to notices of cancellation given under section 41GL on or after the
commencement of item 26, whether the breach to which the notice relates occurs
before or after that commencement.
Sub-item (3) provides that the amendments to subsection 41GN(1) of the Act made by
item 22 apply in relation to proposed cancellations of which a person is informed
under subsection 41GN(2) of the Act on or after the commencement of item 26,
whether circumstances giving rise to the proposed cancellation occurred or occur
before or after that commencement.
Sub-item (4) provides that the amendments to subsection 41JA(1) of the Act made by
item 23 apply in relation to notices given under subsection 41JA(1) on or after the
commencement of item 26. This is the case whether:
for a notice given to an applicant for a conformity assessment certificate or the
inclusion of a kind of device in the Register - the application is made before or
after that commencement; or
for a notice given to a holder of such a certificate (or a person who previously
held such a certificate at any time in the previous 5 years) the certificate was
issued before or after that commencement; or
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for a notice given to a person who is or was a sponsor of a kind of medical
device included in the Register - the kind of device was included in the Register
before or after that commencement.
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SCHEDULE 2 -- Obtaining information etc.
Therapeutic Goods Act 1989
This Schedule contains amendments to the Act to remove inconsistencies between the
matters in relation to which an applicant must certify when including certain kinds of
therapeutic goods in the Register, and the Secretarys ability to require information
and documents from sponsors about the correctness of those certifications. The
Schedule also amends the offence and civil penalty provision at subsections 31(5A),
(5B) and (6), and section 31AAA, of the Act, relating to the provision of false and
misleading information in response to a request for information or documents under
section 31 of the Act, to allow those provisions to apply in respect of anyone to whom
the Secretary can issue a notice under section 31.
Items 1, 12 and 15
Currently under subsection 30(1C) of the Act the Secretary may, by written notice,
cancel the listing of a medicine listed in the Register under section 26A of the Act if:
(a) the Secretary has given the person in relation to whom the medicine is listed a
notice under section 31 of the Act requiring them to provide information or
documents; and
(b) the notice is given for the purposes of ascertaining whether the medicine should
have been listed; and
(c) the person fails to comply with the notice within 20 working days.
Item 1 amends paragraph 30(1C)(2)(b) to remove the reference to the section 31
notice having been given for the purposes of ascertaining whether the medicine
should have been listed, and to refer instead to that notice having been given in order
to ascertain whether any of the certifications made by the person subsections 26A(2)
or (2A) of the Act are incorrect.
This amendment has the effect of aligning the revised description of the Secretarys
power to obtain information from sponsors about whether or not certifications they
made when applying to include their goods in the Register are correct (see items 3, 13
and 17 below), with the ground for cancelling the goods from the Register if the
sponsors fail to provide the requested information.
Items 12 and 15 make equivalent amendments to paragraphs 32GB(1)(b) and
41GM(1)(b) of the Act in relation to biologicals and medical devices, respectively.
Item 2
This item adds a reference to documents in the heading of section 31 of the Act to
reflect the fact that the Secretary can request documents as well as information under
that provision.
Item 3, 13 and 17
Paragraph 31(2)(fa) of the Act currently provides that the Secretary may require a
person seeking to list their goods in the Register, or a person in relation to whom
therapeutic goods are, or have been at any time in previous 5 years, listed in the
Register, to provide information or documents relating to a number of the matters in
15
relation to which that person certified at the time they included their goods in the
Register, being matters relating to criteria their goods must meet before being
included in the Register.
The effect of the amendment set out in item 3 is to expressly provide that the
information or documents the Secretary can seek can relate to any of the matters in
relation to which the sponsor is required to certify under section 26A of the Act before
entering their goods in the Register. This will have the effect of ensuring that the
Secretary can ask a sponsor of a listed medicine for information or documents relating
to any of the matters certified to by that person when listing their medicines in the
Register.
The Secretary can cancel the goods from the Register if any of these certifications is
incorrect (paragraph 30(2)(ba) of the Act refers). The amendment in item 3 will thus
allow the Secretary to seek information or documents from the sponsor of a medicine
listed under section 26A relevant to this ground of cancellation.
Item 13 makes an equivalent amendment to subsection 32JA(1) of the Act in relation
to Class 1 biologicals, and item 17 makes an equivalent amendment to subsection
41JA(1) of the Act in relation to medical devices.
Items 4 - 8
Subsections 31(5A), (5B) and (6) of the Act contain a criminal offence for providing
information that is false or misleading in a material particular, in response to a notice
to provide information or documents under section 31, by a person in relation to
whom a medicine is listed under section 26A of the Act.
No such offence is currently included for others to whom the Secretary can, under
section 31 of the Act, require information or documents to be provided even though
that information may well be relevant to the continued inclusion of the goods in the
Register on the basis of quality or safety. The same justification for making it an
offence to provide false or misleading information in relation to an application for
registration or listing (sections 22A and 21A of the Act refer) are applicable here i.e.
the integrity of the regulatory regime depends on the Secretary being able to make
decisions based on accurate information.
Persons to whom a section 31 notice may be given, but who are not currently covered
by this offence, include applicants seeking to register their goods in the Register under
section 25 of the Act, sponsors seeking to list their goods in the Register under section
26 of the Act and sponsors of goods already registered or listed in the Register, as
well as persons in relation to whom goods were registered or listed at any time in the
previous 5 years.
Item 4 therefore introduces new paragraphs 31(5A)(a) - (c) making it clear that the
offence in section 31(5A) may apply to any person issued a notice under section 31
and who provide either information or documents.
Item 5 makes a minor consequential change to subparagraphs 31(5A)(d)(i) and (ii) of
the Act to reflect the changes made by item 4 that the offence applies to all persons to
whom a section 31 request for information or documents is given by the Secretary.
16
Items 6 and 7 implement equivalent amendments to subsection 31(5B) of the Act to
reflect that the offence applies to any person issued with a notice under section 31.
Item 8 makes a consequential and equivalent amendment to subsection 31(6) of the
Act to replace the reference to a person whose goods are listed under section 26A to
any person in relation to whom a section 31 notice may be issued.
Item 9
This item makes a change to the heading of section 31AAA of the Act describing
what the civil penalty provision is directed at, to reflect the changes set out in item 10
below.
Items 10 and 11
Section 31AAA of the Act sets out a civil penalty for the same conduct covered by
current subsections 31(5A), (5B) and (6) of the Act that create a criminal offence.
As with the criminal offence, the civil penalty provision currently only extends to
cover persons who provide false and misleading information in a material particular
who are sponsors of goods listed in the Register under section 26A.
In order to bring section 31AAA into line with the changes made to subsections
31(5A), (5B) and (6) by items 4-8 so that any person who is issued with a section 31
notice may be affected by that civil penalty provision, item 10 replaces paragraphs
31AAA(a) and (b) with new paragraphs (a) and (b). The effect is that any person
issued a notice under section 31 and who, in response, supplies information or
documents that is false or misleading in a material particular may contravene the civil
penalty in section 31AAA.
Item 11 makes a minor change to paragraph 31AAA(c) to refer to documents as well
as to information, to be consistent with section 31, which enables the Secretary to
require both information or documents from a sponsor, applicant or previous sponsor.
Items 14 and 18
Under subsection 32JB(1) of the Act, a person commits an offence if the person is
given a notice by the Secretary under section 32JA of the Act to provide information
or documents about biologicals and the person fails to comply with the notice. The
maximum penalty for this offence is 500 units.
As currently drafted, the persons who may commit the offence in subsection 32JB(1)
of the Act include persons who are applicants for the inclusion of a biological in the
Register (paragraph 32JA(1)(a) refers).
Other persons who may commit the offence in subsection 32JB(1) are persons in
relation to whom biologicals are included in the Register, and persons in relation to
whom biologicals were included in the Register at any time in the previous 5 years.
It is not considered necessary, however, for this offence to apply to applicants for the
inclusion of a biological in the Register. This is because such persons would already
have an incentive to respond to a section 31JA request for information or documents,
17
in that not doing so may affect the Secretarys ability to evaluate their application. By
not responding to the request, the applicant risks rejection of the application.
Moreover, as making an application to include biologicals (or medical devices) in the
Register is only a requirement if a person chooses to supply the goods in Australia, it
would be inappropriate to make it an offence not to provide additional information or
documents.
Item 14 therefore amends subsection 32JB(1) of the Act, with the effect that the
offence in subsection 32JB(1) would only apply, in appropriate circumstances, to
persons in relation to whom biologicals are included in the Register, and persons in
relation to whom biologicals were included in the Register at any time in the previous
5 years, and not to applicants for the inclusion of a biological in the Register.
Item 18 sets out an equivalent amendment in relation to medical devices, removing
applicants for the inclusion of a kind of medical device in the Register from the scope
of the offence in subsection 41JB(3) of the Act (this offence mirrors subsection
32JB(1)).
These amendments will bring these offences for biologicals and medical devices into
line with the relevant offence in relation to registered or listed therapeutic goods,
which already excludes applicants (subsection 31(4) of the Act refers).
Item 16
This item adds a reference in the heading of section 41JA of the Act to documents to
reflect the fact that the Secretary can request documents as well as information under
that provision.
Application
Item 19
This item sets out the application of various items in this Schedule.
Sub-item (1) provides that the amendments to sections 30, 31 and 31AAA made by
items 1-11 apply in relation to notices of cancellation given under section 31 of the
Act on or after the commencement of item 19, whether the medicine to which the
notice relates is registered or listed before or after that commencement.
Sub-item (2) provides that the amendments to sections 32GB, 32JA and 32JB of the
Act made by items 12-14 apply in relation to notices for the provision of information
or documents given under section 32JA of the Act on or after the commencement of
item 19. This is the case whether:
for a notice given to an applicant for the inclusion of a biological in the Register -
the application is made before or after that commencement, and
for a notice given to a sponsor of a biological included in the Register - the
biological was included before or after that commencement.
Sub-item (3) provides that the amendments to sections 41GM, 41JA and 41JB of the
Act made by items 15-18 apply in relation to notices for the provision of information
18
or documents given under section 41JA of the Act on or after the commencement of
item 19. This is the case whether:
for a notice given to an applicant for a conformity assessment certificate or the
inclusion of a kind of device in the Register - the application is made before or
after that commencement; and
for a notice given to a holder of such a certificate or a sponsor of a kind of
medical device - the certificate was issued, or the kind of device included in the
Register, before or after that commencement.
19
SCHEDULE 3 -- Goods that are not therapeutic goods
Therapeutic Goods Act 1989
This Schedule contains amendments to the Act to allow the Minister to exclude from
the definition of ,,therapeutic goods in subsection 3(1) of the Act goods determined
by the Minister in a legislative instrument goods not to be therapeutic goods, or not to
be therapeutic goods when used, advertised or presented for supply in a specified way.
The Schedule also includes a power for the Secretary to remove products from the
Register that are not therapeutic goods.
Items 1 and 2
,,Therapeutic goods are defined, broadly, in subsection 3(1) of the Act as goods that
are represented in any way to be, or that are, whether because of the way in which
they are presented or for any other reason, likely to be taken to be for therapeutic use.
,,Therapeutic use is defined in subsection 3(1), as use in or in connection with a
number of matters, listed in paragraphs (a) - (f). Paragraphs (a) and (b) of that term
refer, respectively, to use in or in connection with:
(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect
or injury in persons; or
(b) influencing, inhibiting or modifying a physiological process in persons.
Subsection 3(1) also sets out, however, that the definition of therapeutic goods does
not include the goods listed in paragraphs (e) - (f) of the definition.
These include, for example, goods (other than goods declared to be therapeutic goods
in an order under section 7 of the Act) for which there is a standard (within the
meaning of subsection 4(1) of the Food Standards Australia New Zealand Act 1991)
(paragraph (e) of the definition of ,,therapeutic goods refers) or which have a tradition
of use as foods in Australia or New Zealand (paragraph (f) of the definition of
,,therapeutic goods refers).
Item 1 amends the definition of ,,therapeutic goods in subsection 3(1) of the Act to
include two additional excluding paragraphs, (g) and (h).
New paragraph (g) excludes from the meaning of ,,therapeutic goods goods in
relation to which the Minister has made a determination under new subsection
7AA(1). New paragraph (h) excludes from the meaning of ,,therapeutic goods goods
in relation to which the Minister has made a determination under subsection 7AA(2) -
if the goods are used, advertised or presented for supply in the manner specified in the
determination.
These amendments have the effect that the goods described in those paragraphs - i.e.
goods which the Minister specifies in a determination under new subsections 7AA(1)
or (2) - will be taken not to be within the meaning of the term ,,therapeutic goods for
the purposes of the Act.
20
Item 2 introduces new section 7AA. New subsection 7AA(1) provides that the
Minister may, by legislative instrument, determine that specified goods (other than
goods declared to be therapeutic goods under an order in force under section 7) are
excluded goods for the purposes of the Act.
New subsection 7AA(2) provides that the Minister may, by legislative instrument,
determine that specified goods (other than goods declared to be therapeutic goods
under an order in force under section 7) are excluded goods when used, advertised or
presented for supply in the manner specified in the determination.
The effect of items 1 and 2, taken together, is to provide the Minister with the power
to make a determination identifying products that will be taken to be excluded from
the meaning of ,,therapeutic goods for the purposes of the Act, under new section
7AA, including where the goods in question may otherwise come within the
,,therapeutic goods definition.
Any determination made by the Minister must be tabled in Parliament, and will be a
disallowable instrument.
Inclusion of goods in a subsection 7AA(1) determination would mean that, regardless
of whether suppliers of the goods claimed that using the goods provided a therapeutic
benefit or not, such items would be excluded from the definition of ,,therapeutic
goods and thus would be outside the scope of the legislation.
New section 7AA would also enable the Minister to specify in a determination that a
particular product is not a therapeutic good if used, advertised or presented for supply
in a specified manner, including if the product is used, advertised or presented for
supply in a way other than a particular way of using, advertising or presenting the
product.
These measures address the significant concern that, due to its breadth, the definition
of ,,therapeutic goods may potentially extend to a wide range of goods, including
clothing, household items and other products, for which public health is not, or is
unlikely to be, an issue, and where the focus may be more one of consumer
protection. The definition may also extend to products for which there may be sound
and important public policy reasons for excluding from the scope of the regulatory
scheme under the Act.
Health claims are increasingly being made about a wide range of products, suggesting
that these products can influence a persons well-being or state of mind.
Some recent examples of goods for which therapeutic use claims have been made
include mattresses which contain bacteria spores designed to reduce the effects of dust
mites and ,,power band bracelets, where it was claimed that the use of the latter
would boost a wearers balance, strength and flexibility.
Many of the therapeutic claims being made about a wide range of products may be
more appropriately addressed through consumer protection laws than under the Act.
21
This new power will allow the Minister to respond flexibly, on a case by case basis, to
ensure the Therapeutic Goods Administration is not involved in the regulation of
products for which there is no public health focus or for which there may be sound
public policy reasons for their not being regulated under the therapeutic goods
legislation.
Section 7 of the Act currently provides that where the Secretary is satisfied that
particular goods are or are not therapeutic goods, or are or are not therapeutic goods
when used, advertised or presented for supply in a particular way, she may, by order
published in the Gazette, declare the goods to be therapeutic goods or not. However,
the Secretary may only exercise these powers to declare a product not to be a
therapeutic good if satisfied that the product is not, in fact, a therapeutic good. As
such, section 7 would not provide a basis for excluding from the regulatory scheme in
the Act products which come within the scope of the definition of ,,therapeutic goods
in subsection 3(1) of the Act or where there may be uncertainty as to their
characterisation.
The power for the Minister under new section 7AA of the Act will not require the
Minister to come to a view that a product is not in fact therapeutic goods for it to be
included in a determination.
It should also be noted that the Act sets out significant penalties for importing into,
exporting from, or supplying in, Australia, goods that come within the definition of
therapeutic goods if those goods are not included in the Register or are not otherwise
exempt or approved (sections 19B and 19D of the Act refer). Moreover, inclusion in
the Register involves complying with a number of regulatory requirements, such as
complying with all relevant standards, ensuring that the goods are manufactured
according to good manufacturing principles and ensuring that the goods are safe for
the purposes for which they are intended to be used. Application fees and annual
charges are also payable.
It is important therefore for product suppliers as well as the public that there is as
much clarity as possible about which goods are covered by the regulatory scheme.
The new power will give the Minister the ability to clarify that particular goods which
come within the definition, or where there may be uncertainty about whether or not
they come within the definition, are not to be regulated under the Act.
Items 3 and 4
These items make amendments to subsection 8(1) of the Act consequential to the
amendments made by items 1 and 2 above.
Subsection 8 of the Act allows the Secretary to, by written notice, require a person
importing into, or supplying in, Australia, therapeutic goods or goods in relation to
which the Secretary is considering making a declaration under section 7 of the Act, to
provide information relating to the composition, indications, directions for use,
labelling or advertising of the goods.
Item 3 makes a minor formatting change to paragraph 8(1)(b) to accommodate item 4.
22
Item 4 adds a new paragraph 8(1)(c) to the Act, the effect of which is to allow the
Secretary to require importers and suppliers of goods in relation to which the Minister
is considering making a determination under new section 7AA to provide information.
This will allow the Secretary to collect relevant information of the kind referred to
above which can then be provided to the Minister for the purposes of making such a
determination.
Item 5
This item adds new section 9F to the Act.
New section 9F says that if there is an entry on the Register and the Secretary is
satisfied that the goods are not therapeutic goods, the Secretary may remove the entry
of the goods from the Register.
This power of removal is to be distinguished from the Secretarys existing powers
under the Act to cancel therapeutic goods from the Register (including sections 30,
32GA, 32GB, 32GC, 41GK, 41GL, 41GM and 41GN of the Act).
Section 9F provides a specific power for the Secretary to remove a product from the
Register where either a product was not ,,therapeutic goods within the meaning of the
definition of that term in subsection 3(1) of the Act at the time it was included in the
Register (for instance, it was a food within paragraph (e) or (f) of that definition) or at
any time after its inclusion a product no longer meets that definition (where, for
instance, therapeutic claims are no longer made in relation to the goods, or a
declaration is made under section 7AA in relation to the goods).
Under the risk-based regulation contained in the Act, some low-risk products are
included in the Register without prior assessment by the TGA. For instance, an
applicant for the inclusion of a complementary medicine in the Register can list the
goods by means of the Electronic Listing Facility (ELF) under section 26A of the Act
based on a series of certifications made by the applicant about the goods. Similarly,
an applicant for the inclusion of a low-risk kind of medical device can include the
goods on the Register using the Device Electronic Application Lodgement system
(DEAL) under subsection 41FF(1) of the Act on the basis of certifications made by
the applicant under section 41FD of the Act.
There is no opportunity for the TGA to come to a view about whether the product
comes within the definition of ,,therapeutic goods before it is included in the Register.
There may also be situations in which a product may have been a ,,therapeutic good
at the time of entry on the Register, but has subsequently changed such that it ceases
to be covered by the definition.
The introduction of new section 9F is intended to address these situations so that only
products that are in fact ,,therapeutic goods are, or continue to be, regulated under the
regulatory scheme. Subsection 9A(1) of the Act makes it clear that the Secretarys
responsibility in maintaining the Register is limited to ,,therapeutic goods.
It is important to note that, under new subsection 9F(3), before removing a product
from the Register the Secretary will be required to inform the person in relation to
23
whom the product is entered on the Register, and invite them to make written
submissions in relation to the proposed removal. Under new subsection 9F(4), the
Secretary would be required to consider any such submissions before exercising her
powers of removal. This will allow the sponsor to provide information or evidence
that might demonstrate that the product is in fact therapeutic goods and thus should
remain on the Register.
A notice of any removal that takes place must be published on the Departments
website. Any decision made by the Secretary to remove the product from the Register
is also subject to internal review, with a further avenue of review to the
Administrative Appeals Tribunal (the AAT).
New subsection 9F(5) provides that a notice of removal given to a person by the
Secretary under new subsection 9F(2) is not a legislative instrument. The inclusion of
this subsection is intended to assist readers, as such notices would not appear to be
legislative instruments within the meaning of section 5 of the Legislative Instruments
Act 2003.
Item 6
This item makes a minor amendment to section 56A of the Act consequential to the
addition of new section 7AA.
Section 56A of the Act enables the Secretary to certify certain facts about matters set
out under that provision, which will be taken as prima facie evidence of the matters
specified in the certificate for the purposes of proceedings for an offence or a
contravention of a civil penalty provision under the Act.
Item 6 introduces a new paragraph 56A(1)(ha) to the Act, with the effect that the
Secretary will be able to certify, under that paragraph, that as at a certain time or
during a certain period of time, there was no determination under section 7AA of the
Act in place in relation to particular goods. This will facilitate, for instance, evidence
being provided to a court in relation to an issue about whether a product was or was
not therapeutic goods at a particular time, that no determination was in place at that
time that it was not therapeutic goods.
Item 7
Section 60 provides persons whose interests are affected by an ,,initial decision made
by the Secretary under the Act with a right to seek a review of that decision by the
Minister, and also provides a right of review of the Ministers decision by the AAT.
This item makes a consequential amendment to section 60 of the Act in light of the
addition of a new secretarial power to remove goods from the Register that are not
therapeutic goods under new section 9F to the Act, to provide for internal review
rights where that power is exercised.
Item 7 amends subsection 60(1) of the Act to add decisions of the Secretary under
new section 9F to remove products that the Secretary is satisfied are not therapeutic
goods from the Register, as a decision that may be reviewed by the Minister (and
subsequently, by the AAT).
24
Application
Item 8
This item sets out how new section 9F will operate.
Item 8 provides that new section 9F introduced by item 5 of this Schedule applies to
goods entered on the Register before or after the commencement of item 8. This
means the Secretary can remove products that are not therapeutic goods that were on
the Register before that section came into operation.
25
SCHEDULE 4 -- Restricted representations and prohibited representations
Therapeutic Goods Act 1989
This Schedule contains amendments to the Act to remove a small number of
inconsistencies relating to advertising offences in Division 3A of Part 5-1 of the Act,
and to clarify that when, at her own initiative, the Secretary permits the use of a
restricted or prohibited representation in an advertisement for therapeutic goods, the
Secretary may impose conditions on that permission.
Item 1
Under subsection 42DK(1) of the Act, the Secretary may, on her own initiative,
permit the use of a restricted representation in relation to therapeutic goods, including
the use of such a representation on the label or packaging of the goods.
Under subsection 42DK(2) of the Act, the Secretary may, on her own initiative,
permit the inclusion of a prohibited representation on the label of therapeutic goods,
or in information in the package in which therapeutic goods are contained, if the
representation is necessary for the appropriate use of the goods.
The Act does not, however, provide for the Secretary to impose conditions when
deciding to permit the use of a restricted or prohibited representation under sections
42DK(1) or (2).
This contrasts with the Secretarys ability to impose conditions when she grants an
approval to use a restricted representation in response to an application for such an
approval under section 42DF of the Act.
To remove this inconsistency, and to enable the Secretary to put in place appropriate
safeguards on the use of restricted or prohibited representations permitted under
section 42DK, item 1 adds new subsection 42DK(3) to the Act to make it clear that
the Secretary may permit the use of restricted or prohibited representations subject to
any conditions specified by her under that new provision.
Item 2
Currently under paragraph 42DL(1)(a) of the Act, it is an offence for a person to
publish or broadcast an advertisement about therapeutic goods that contains a
prohibited representation (whether in express terms or by necessary implication)
about the goods.
Paragraph 42DL(1)(a) of the Act does not reflect the fact that the Secretary can
actually permit the use of a prohibited representation on the label of therapeutic
goods, or in information included in the package in which therapeutic goods are
contained, under subsection 42DK(2) of the Act.
This is to be contrasted with paragraph 42DL(1)(c) of the Act, which makes it clear
that the offence set out in that provision for publishing or broadcasting an
advertisement containing a restricted representation only applies where the use of the
representation has not been approved under subsection 42DF(1), or permitted under
subsection 42DK(1), of the Act.
26
Item 2 therefore amends paragraph 42DL(1)(a) with the effect that the offence in
paragraph 42DL(1)(a) will only apply where the use of the prohibited representation
has not been permitted under subsection 42DK(2) of the Act.
Item 3
This item makes a minor amendment to subsection 42DL(2) of the Act for the
purpose of achieving consistency in relation to strict liability.
Subsection 42DL(2) of the Act sets out that for the purposes of an offence against
subsection 42DL(1), strict liability applies to specified physical elements of a number
of the offences listed at paragraphs 42DL(1)(a) - (h).
Item 3 amends subsection 42DL(2) to include a new paragraph 42DL(2)(aa), to note
that strict liability also applies to the element of the offence, as amended under
paragraph 42DL(1)(a), covering the use of a prohibited representation that has not
been permitted under subsection 42DK(2) of the Act.
Item 4
Currently under paragraph 42DL(3)(a) of the Act, it is a defence to a prosecution
under paragraphs 42DL(1)(a) or (f) of the Act in relation to an advertisement
containing a prohibited representation or a statement referring to goods, substances or
preparations included in Schedules 3, 4 or 8 of the Poisons Standard, if the
advertisement in question has been made by, or on behalf of, the Commonwealth.
There is not an equivalent defence, however, to a prosecution under paragraph
42DL(1)(c) of the Act for publishing etc. an advertisement containing a restricted
representation the use of which has not been permitted by the Secretary under
subsection 42DK(1) of the Act.
This would appear to be inconsistent with the availability of this defence in relation to
the use of a prohibited representation (paragraph 42DL(1)(a) of the Act refers).
Item 4 would amend paragraph 42DL(3)(a) of the Act to achieve consistency in the
availability of the defence where the advertisement has been made by, or on behalf of,
the Commonwealth.
Application
Item 5
This item sets out the application of the amendments made under this Schedule.
Sub-item (1) provides that the amendments to section 42DK of the Act made by item
1 apply in relation to permissions given under section 42DK on or after the
commencement of sub-item (1).
Sub-item (2) provides that the amendments to section 42DL of the Act made by items
2-4 apply in relation to advertisements published or broadcast on or after the
commencement of sub-item (2).
27
SCHEDULE 5 -- Evaluation and registration of therapeutic goods
Therapeutic Goods Act 1989
This Schedule contains amendments the Act to clarify that after completing an
evaluation of an application for registration in the Register, the Secretary must decide
to either register or not register the goods in question, and to make it clearer what
steps the Secretary must take following such a decision. The Schedule contains
amendments which make it clearer under which provision of the Act product
information for medicines accepted for registration is approved.
Item 1
This item makes a minor consequential change to paragraph 19A(8)(b) of the Act, to
reflect the changes to be introduced by item 4 below.
Item 2
This item makes a minor consequential change to subsection 24D(3) of the Act, to
also reflect the changes to be introduced by item 4 below.
Item 3
This item amends the heading of section 25 of the Act to remove the reference to "and
registration", to reflect the changes to be introduced by items 4 and 5 below.
Item 4
Section 25 of the Act deals with the matters which the Secretary must consider when
evaluating an application for registration in the Register, and the steps the Secretary
must take after completing the evaluation process and after a decision has been made
as to whether or not to register the goods the subject of an application for registration.
However, section 25 does not currently expressly set out that the Secretary must make
a decision as to whether or not to register the goods.
This power has been understood as being implied within section 25, for example in
subsections (3) and (4) of the Act, which set out the steps the Secretary must take in
relation to notifying applicants of a decision to register or not register their goods.
Item 4 amends section 25 to (taken together with item 5) provide greater clarity about
the operation of this provision.
To that end, item 4 replaces subsections 25(3), (4) and (5) of the Act with a new
subsection 25(3) which sets out that after completing an evaluation of goods under
section 25, the Secretary must decide to either register the goods or not to register the
goods.
Item 5
This item introduces new sections 25AAA and 25AAB to the Act.
New section 25AAA sets out the steps that the Secretary must take to notify
applicants for registration when an application has been successful, including
notifying applicants in writing of the Secretarys decision to register goods within 28
28
days of making the decision (new subsections 25AAA(1) (for therapeutic devices) and
(2) (for other therapeutic goods) refer).
New subsection 25AAA(3) of the Act essentially replicates the functions currently
contained in subsection 25(4) of the Act, but provides greater clarity about the
processes leading to the actual registration of goods in the Register.
New subsection 25AAA(3) requires that the Secretarys notice given to an applicant
of the decision to register goods must also advise the applicant that, notwithstanding
the decision on registration, the goods will not be included in the Register unless and
until:
(a) the applicant gives the Secretary the certificate required under subsection
26B(1) of the Act, or a notice (using the approved form) that such a certificate
is not required; and
(b) for restricted medicines and any other medicine in relation to which the
Secretary has indicated that the applicant must provide product information as
part of their application - the Secretary has approved product information in
relation to the medicine under subsection 25AA(1) of the Act.
The effect of new subsection 25AAA(3) is to make it clear that these steps must be
completed before a medicine that has been approved for registration can actually be
included in the Register.
New paragraph 25AAA(3)(b) (taken together with the changes in item 6), by
conferring an express power on the Secretary to approve product information under
subsection 25AA(1), clarifies that it is under subsection 25AA(1) that the product
information which is evaluated as part of the registration evaluation process
(paragraph 25(1)(da) of the Act refers) is approved.
New section 25AAB sets out that if the Secretary decides, in relation to an application
for registration, not to register the goods, she must - within 28 days - notify the
applicant of the decision, and her reasons for it. This mirrors the existing
requirements in subsection 25(4) for such circumstances.
Item 6
Subsection 25AA(1) currently provides that if the Secretary includes a medicine in the
Register in relation to which product information is required to be approved, the
product information that is approved under subsection 25AA(1) is the product
information referred to in subparagraph 25(4)(d)(ai) of the Act.
Item 6 amends subsection 25AA(1) of the Act to clarify that the Secretary must
approve product information in relation to therapeutic goods if the Secretary:
has decided under subsection 25(3) to register goods for which product
information is required to accompany the application; and
is satisfied that the product information in question is appropriate in the
circumstances.
29
Items 7, 8 and 9
These items make minor, consequential amendments to each of paragraphs
25AA(2)(b) and (3)(b), 25AA(3)(c) and subsection 26BA of the Act to reflect the
changes introduced by item 5.
Item 10
This item amends subsection 60(1) to make clear that decisions of the Secretary under
section 25AA of the Act are not ,,initial decisions for the purposes of section 60.
The main effect of this change is that a decision by the Secretary to approve product
information under new subsection 25AA(1) for a medicine which the Secretary has
decided to register under new subsection 25(3), will not be subject to a separate right
to internal review or subsequent merits review by the AAT under section 60 of the
Act. However, the decision remains amenable to judicial review.
A decision by the Secretary to vary approved product information under subsection
25AA(4) of the Act for a medicine that is already registered in the Register in relation
to which a variation in the Register entry has been approved, will also not be subject
to a separate right to internal or AAT review.
These amendments principally reflect that a decision to approve product information
for a medicine is an integral part of the decision to actually register the medicine, and
that the content of the product information essentially underpins the registration
decision and the basis on which the Secretary has decided, after evaluating a
medicine, that it is suitable for registration.
The Bill clarifies that the approval by the Secretary of product information for a
medicine is a separate decision to the Secretarys decision approving its registration
(in the case of an application for registration under section 23 of the Act) or varying
the entry of the medicine in the Register (in the case of a request under section 9D of
the Act by the sponsor of a registered medicine to vary the entry of the medicine in
the Register). However, in practice the product information is always reviewed at the
same time as the application for registration is evaluated or the request for a variation
is being considered (see for instance, paragraph 25(1)(da) of the Act).
The Secretary would not be expected to accept a medicine for registration (or make a
variation to the Register entry of a registered medicine) unless satisfied that the
content of the product information was correct and properly reflective of the
circumstances in which the medicine was considered suitable for registration (or
continued registration) on the basis of its quality, safety and efficacy for the purposes
for which it is to be used (paragraphs 25(1)(d) and 9D(3)(c) of the Act refer).
A person whose interests are affected by a decision under the new subsection 25(3)
(see item 4 in Schedule 5 below) to register a medicine in relation to which PI must be
provided, or by a decision by the Secretary under subsection 9D(1), (2) or (3) to vary
the entry in the Register of such a medicine, has a right to seek internal review of that
decision. As the product information approved by the Secretary will reflect the
decision of the registration or variation decision of the Secretary (which is amenable
to review) issues with the PI can effectively be addressed through a review of the
registration or variation decision.
30
Application
Item 11
This item sets out how the amendments under this Schedule will operate.
Sub-item (1) provides that the amendments to sections 19A, 24D and 25 of the Act
made by items 1-4 apply in relation to evaluations for registration completed on or
after the commencement of sub-item (1).
Sub-item (2) provides that new sections 25AAA and 25AAB apply in relation to
therapeutic goods the evaluation of which under section 25 of the Act is completed on
or after the commencement of sub-item (2).
Sub-item (3) provides that the amendments to sections 25AA of the Act made by
items 6-8 apply in relation to therapeutic goods the evaluation of which under section
25 of the Act is completed on or after the commencement of sub-item 3.
The effect of these application provisions is that, in relation to an evaluation
completed after commencement of the amendments, any notification by the Secretary
under section 25 of the outcome will be done in accordance with section 25 as so
amended and the new sections 25AAA and 25AAB.
Sub-item (4) provides that the amendments to section 60 of the Act made by item 10
apply in relation to product information approved on or after the commencement of
sub-item (4).
31
SCHEDULE 6 -- Conditions of registration or listing
Therapeutic Goods Act 1989
This Schedule contains amendments to the Act to allow new conditions of registration
or listing, or the variation of an existing condition of registration or listing, to
commence earlier than the current 28 days after the date notice of the new or varied
condition is given to the sponsor, where the sponsor has requested the new or varied
condition. The Schedule also allows a removal of a condition, whether upon request
by the sponsor or on the Secretarys own initiative, to commence earlier than the
current 28 day period.
Item 1
Under subsection 28(3) of the Act, the Secretary may, by written notice, impose new
conditions on the registration or listing of goods already included in the Register, and
vary or remove conditions imposed under subsection 28(2B) of the Act. Subsection
28(3A) of the Act sets out that the Secretarys power under subsection 28(3) may be
exercised by the Secretary of her own motion, or upon a request by the person in
relation to whom goods are registered or listed.
Under subsection 28(4) of the Act, the imposition of a new condition, or the variation
or removal of an existing 28(2B) condition, takes effect:
(a) if the action is necessary to prevent imminent risk of death or serious illness or
injury - on the day on which notice is given; or
(b) in any other case, on a day specified in the notice, not being earlier than 28 days
after notice is given.
The requirement noted in (b) above that new conditions, or the variation or removal of
existing conditions, may not start earlier than 28 days after notice is given (except
where there is an imminent risk of death etc.) precludes the Secretary from responding
flexibly to requests by sponsors for such measures.
Such requests may seek a change in conditions to allow particular batches of goods to
be supplied without breaching an existing condition (e.g. to allow a slightly different
shelf-life to apply for a particular batch), or a new condition to address concerns the
regulator might have about some batches of goods.
In such circumstances, the changes may need to be imposed earlier than 28 days after
the notice in order to achieve a quicker result (and, by corollary, may not need to be in
place for long).
To address this issue, this item amends subsection 28(4) to allow the imposition of
new conditions, and the variation of existing conditions - where these have been
requested by the person in relation to whom the goods are registered or listed - to
commence on a day specified in the notice (not being earlier than the actual day notice
is given), rather than only after 28 days from the date of notice.
The item also allows the removal of existing conditions to commence on the day
specified in the notice, rather than after 28 days, regardless of whether the change was
requested by the sponsor.
32
Allowing for the removal of a condition earlier than 28 days from the date of notice in
both cases - i.e. where a person has requested it, and where the Secretary has removed
a condition on her own initiative - reflects that, in either situation, there will be
expected to be a benefit to the sponsor in terms of a reduction in their regulatory
burden through the removal of the condition.
Item 2
Currently under paragraph 28(5)(e) of the Act, registered or listed goods are subject to
a condition that the person in relation to whom the goods are registered or listed will
comply with any reporting requirements prescribed for the purposes of that paragraph.
,,Reporting requirements here refers to requirements relating to pharmacovigilance
reporting - i.e. the reporting of adverse reactions to therapeutic goods.
Regulation 15A of the Therapeutic Goods Regulations 1990 currently prescribes
reporting requirements for the purposes of paragraph 28(5)(e) of the Act for sponsors
of registered and listed medicines. It sets out that such sponsors must comply with the
reporting requirements set out in the TGA document ,,Australian Requirements and
Recommendations for Pharmacovigilance Responsibilities of Sponsors, as in force
from time to time.
In addition to reporting requirements, however, the maintaining of accurate and up to
date records relating to adverse reactions is also important, particularly for ensuring
that sponsors are able to meet their reporting requirements in relation to adverse
reactions, and generally in terms of supporting effective safety monitoring.
As such, it is envisaged that, in the future, the TGA document referred to in regulation
15A may (following appropriate consultation, and the completion of best practice
regulation requirements) be amended to include record-keeping requirements.
Item 2 therefore amends paragraph 28(5)(e) of the Act to include a reference to
record-keeping requirements, to facilitate that outcome.
Item 3
This item implements equivalent amendments to those set out in item 1, in relation to
when conditions imposed on the inclusion of a biological in the Register can
commence to operate.
Items 4 and 5
Subsection 41EL(1) of the Act allows the Secretary to impose new conditions on a
conformity assessment certificate after it has been issued to a manufacturer of medical
devices, or vary or remove existing conditions, either on the Secretarys own initiative
or upon request by the manufacturer.
Such conditions may relate to the kinds of devices manufactured by the certificate
holder, or to the manufacturers quality management system.
Subsection 41EL(2) provides that the imposition or variation of such a condition will
take effect:
33
(a) if the action is necessary to prevent imminent risk of death or serious illness or
injury - on the day on which notice is given; or
(b) in any other case, on a day specified in the notice, not being earlier than 28 days
after notice is given.
Although subsection 41EL(1) of the Act allows the Secretary to remove existing
conditions applying to a conformity assessment certificate, as well as varying such
conditions and imposing new conditions) subsection 41EL(2) only refers to when the
"imposition or variation of such a condition takes effect".
Item 4 therefore adds a reference to "removal" to subsection 41EL(2) to ensure that
all the regulatory possibilities are covered.
Item 5 then implements equivalent amendments to subsection 41EL(2) of the Act to
those set out in items 1 and 3 above.
Items 6 and 7
Item 6 amends subsection 41FP(2) of the Act to address the same situation as outlined
above in relation to item 4.
Subsection 41FP(1) of the Act allows the Secretary to impose new conditions on the
inclusion of a kind of medical device in the Register, or to vary or remove existing
conditions, either on the Secretarys own initiative or upon the request of the person in
relation to whom the kind of devices are included in the Register.
Subsection 41FP(2) sets out when the imposition or variation of such a condition will
take effect, but does not mention when the removal of a condition under subsection
41FP(1) will commence.
Item 6 therefore adds a reference to ,,removal to subsection 41EL(2) to ensure that all
regulatory possibilities are covered.
Item 7 then implements equivalent amendments to subsection 41FP(2) of the Act to
those set out in items 1, 3 and 5 above.
Application
Item 8
This item sets out the how the amendments made under this Schedule will operate.
Sub-item (1) provides that the amendments to subsection 28(4) of the Act made by
item 1 apply in relation to notices given under subsection 28(3) of the Act (in relation
to the imposition of new conditions of registration or listing, or the variation or
removal of existing conditions) on or after the commencement of sub-item (1).
Sub-item (2) provides that the amendments to subsection 28(5) of the Act made by
item 2 apply in relation to therapeutic goods registered or listed as at, and on or after,
the commencement of sub-item (2).
34
Sub-item (3) provides that the amendments to section 32EE made by item 3 apply in
relation to notices given under that section (in relation to the imposition of new
conditions of inclusion of a biological in the Register, or the variation or removal of
existing such conditions) on or after the commencement of sub-item (3).
Sub-item (4) provides that the amendments to section 41EL made by items 4 and 5
apply in relation to notices given under that section (in relation to the imposition of
new conditions on a conformity assessment certificate, or the variation or removal of
existing conditions) on or after the commencement of sub-item (4).
Sub-item (5) provides that the amendments to section 41FP of the Act made by items
6 and 7 apply in relation to notices given under that section (in relation to the
imposition of new conditions on the inclusion of kinds of medical devices in the
Register, or the variation or removal of existing such conditions) on or after the
commencement of sub-item (5).
35
SCHEDULE 7 -- Presentation
Therapeutic Goods Act 1989
This Schedule contains amendments to the Act to include a new power for the
Secretary to cancel the registration or listing of goods where it appears to the
Secretary that the presentation of registered goods is not acceptable or the
presentation of listed goods is unacceptable.
Item 1
Under subsection 30(2) of the Act, the Secretary may, in writing and subject to
subsection 30(3) of the Act, cancel the registration or listing of therapeutic goods if
one or more of the circumstances listed at paragraphs 30(2)(a) - (f) apply.
Subsection 30(2) of the Act does not, however, currently provide for the Secretary to
cancel the registration or listing of therapeutic goods if the presentation of the goods
is, in the case of listed therapeutic goods, unacceptable or, in the case of registered
therapeutic goods, not acceptable.
The ,,presentation of therapeutic goods means the way in which the goods are
presented for supply and includes matters relating to the name, labelling and
packaging and any advertising or other informational material associated with the
goods.
The requirement for the presentation of goods to be either ,,acceptable (in the case of
registered therapeutic goods) or ,,not unacceptable (in the case of listed therapeutic
goods) is a criterion that must be met before therapeutic goods may be included in the
Register (paragraphs 26(1)(e), 26A(2)(c) and 25(1)(e) of the Act refer). The Act
contains (subsection 3(5) of the Act refers) a description of the circumstances in
which the presentation of therapeutic goods will be taken to be ,,unacceptable.
To ensure that there is a mechanism by which therapeutic goods continue to satisfy
this criteria for so long as they remain entered on the Register, this item amends
subsection 30(2) of the Act to include (at new paragraph 30(2)(aa)) a power for the
Secretary to cancel the registration or listing of therapeutic goods if it appears to the
Secretary that:
the presentation of listed therapeutic goods is unacceptable; or
the presentation of registered therapeutic goods is not acceptable.
It is important to note the distinction between the presentation of listed goods being
,,unacceptable and the presentation of registered goods not being ,,acceptable, in new
paragraph 30(2)(aa).
In relation to the presentation of listed therapeutic goods being ,,unacceptable, this is
intended to refer to the meaning of ,,unacceptable presentation as described in
subsection 3(5) of the Act. This subsection describes the presentation of a good as
unacceptable if it is capable of being misleading or confusing as to the goods content,
proper use or identification and if - without limiting that description - any of the
circumstances at paragraphs 3(5)(a)-(e) apply. Those paragraphs list a series of
36
circumstances e.g. if goods have the same name as another good with different or
additional therapeutically active substances (paragraph 3(5)(b) of the Act refers) and
includes circumstances that are prescribed (paragraph 3(5)(e) of the Act refers).
Regulation 3A of the Regulations covers additional circumstances in which the
presentation of therapeutic goods will be taken to be ,,unacceptable.
In relation to registered goods, whether the presentation of such goods is ,,not
acceptable can encompass a range of factors that might go beyond the scope of the
definition of ,,unacceptable presentation in subsection 3(5) of the Act. For example,
the presentation of registered goods may cover matters such as the consumer medicine
information for the goods.
As both cases suggest, there can be significant safety concerns associated with the
presentation of therapeutic goods not being acceptable, or being unacceptable, and it
is important that the Act contain an appropriate cancellation power to reinforce the
fact that this issue is a factor that is taken into account in determining whether
therapeutic goods should be included, and once included, remain, in the Register.
As with the other Secretarys cancellation powers under subsection 30(2) of the Act,
the Secretary is required under subsection 30(3) to first issue an affected person notice
of a proposal to cancel and give them a reasonable opportunity to make submissions
in relation to the proposal. If the person makes submissions, the Secretary must not
make a decision on cancellation until those submissions have been taken into account.
As a result of including the presentation of the goods as a grounds for cancellation of
listed or registered therapeutic goods from the Register, the Secretary has the option
under section 29D of the Act of suspending the goods from the Register for a period
of not more than 6 months.
Item 2
This item makes a consequential change to section 30EA of the Act, which deals with
the powers of the Secretary to impose requirements on a range of persons in relation
to registered or listed therapeutic goods (or goods that are exempt from, or are the
subject of an approval or authority in relation to, the requirement to be registered or
listed).
Under subsection 30EA(2) of the Act, the Secretary may, in writing, impose on a
person requirements relating to therapeutic goods if any of the circumstances set out
in column 2 of the table in subsection 30EA(1) apply in relation to a person
mentioned in column 3 of that table.
Under item 5A of that table, the Secretary may impose requirements on a person in
relation to whom therapeutic goods are registered or listed if such goods are supplied
by the person and it appears to the Secretary "that the quality, safety or efficacy of the
goods is unacceptable or that the presentation of the goods is unacceptable".
In light of the changes made by item 1, the reference in this description needs to be
updated to reflect the distinction between the presentation of listed goods being
,,unacceptable, and the presentation of registered goods not being ,,acceptable.
37
Item 2 therefore amends item 5A of the table at subsection 30EA(1) to refer to the
presentation of listed goods being unacceptable or the presentation of registered goods
not being acceptable, as circumstances triggering the Secretarys powers to impose
requirements under subsection 30EA(2).
The effect of this will be to make it clear that the Secretarys powers to impose
requirements under subsection 30EA(2) in relation to the presentation of goods apply
in respect of both registered and listed therapeutic goods.
Item 3
Under paragraph 32GC(1)(a) of the Act, the Secretary may (subject to subsection
32GC(2) of the Act), cancel the inclusion of a biological from the Register if (among
other things) the presentation of the biological is ,,unacceptable.
However, this would not appear to be consistent with paragraph 32DE(1)(b) of the
Act, which requires the Secretary to consider, when evaluating an application for the
inclusion of a biological in the Register, if the presentation of the biological is
,,acceptable.
To correct this inconsistency, and to more closely align the cancellation power with
the basis on which biologicals are assessed for marketing approval in relation to
presentation, item 3 replaces the reference to the presentation of a biological being
,,unacceptable in paragraph 32GC(1)(a) with a reference to that presentation being
,,not acceptable.
Item 4
Subsection 32HA of the Act deals with the powers of the Secretary to impose
requirements on a range of persons in relation to biologicals.
Under subsection 32HA(2) of the Act, the Secretary may, in writing, impose on a
person requirements relating to biologicals if any of the circumstances set out in
column 2 of the table in subsection 30EA(1) apply in relation to a person mentioned
in column 3 of that table.
Under item 9 of that table, the Secretary may impose requirements on a person in
relation to whom a biological is included in the Register if (among other things) it
appears to the Secretary that the presentation of the biological is ,,unacceptable.
Item 4 amends item 9 of the table at subsection 32HA(1) of the Act to replace the
reference in item 9 to ,,unacceptable presentation with a reference to the presentation
of a biological being ,,not acceptable.
This will bring the Secretarys recall powers on presentation into line with her
cancellation powers in relation to presentation (as amended by item 3 above) and with
the criteria against which biologicals are evaluated for marketing approval regarding
presentation.
38
Application
Item 5
This item sets out that the amendments made by this Schedule apply in relation to
therapeutic goods included in the Register before and after the commencement of this
item.
39
SCHEDULE 8 -- Consent to the import, supply or export of goods
Therapeutic Goods Act 1989
This Schedule contains amendments to the Act to provide a right of merits review
where, under subsection 15(1) of the Act, the Secretary imposes conditions on the
granting of her consent to the importing into, supplying in or exporting from,
Australia, of therapeutic goods (other than medical devices) that do not comply with
an applicable standard.
Item 1
Sections 14 and 14A of the Act set out criminal offences, and a corresponding civil
penalty provision, relating to the importing into, supplying in or exporting from,
Australia, of therapeutic goods other than medical devices, that do not comply with a
standard made under the Act that is applicable to the goods.
Under these offence and civil penalty provisions, the Secretary may consent to the
importing into, supplying in or exporting from, Australia, of therapeutic goods that do
not comply with an applicable standard, with the effect that if such a consent is in
place the relevant offence or civil penalty will not apply. Under subsection 15(1) of
the Act, the Secretary may give her consent under sections 14 and 14A
unconditionally, or subject to conditions.
However, while a decision of the Secretary to not consent to the importing into etc. of
goods that do not comply with an applicable standard is subject to review by the
Minister under section 60 of the Act (and AAT review), a decision of the Secretary to
impose a condition on such consent is not currently subject to section 60 review.
This is to be contrasted with the situation in relation to decisions by the Secretary to
impose conditions on her consent to the importing into, supplying in or exporting
from, Australia of medical devices that do not comply with the essential principles,
which are subject to review under section 60 (paragraph (k) of the definition of ,,initial
decision in subsection 60(1) of the Act refers).
This item amends the rights of review under subsection 60(1) of the Act to include a
reference to conditions imposed by the Secretary on any granting of consent under
sections 14 or 14A of the Act to the importing into, supplying in or exporting from,
Australia, of therapeutic goods that do not comply with an applicable standard.
The effect here will be to provide sponsors with a right of merits review in relation to
the imposition of conditions on such consents, including a right to appeal to the AAT
in relation to the Ministers review decision.
Application
Item 2
This item sets out that the above amendment will apply in relation to conditions
imposed on or after the commencement of item 2.
40
SCHEDULE 9 -- Review of decisions
Therapeutic Goods Act 1989
This Schedule contains amendments to the Act to make it clear that where the
Minister revokes an initial decision of the Secretary, and makes a decision in
substitution, the substituted decision is to be treated as a decision of the Secretary
(except for the purposes of any review of the substituted decision). The substituted
decision has effect on and from the date determined by the Minister.
Item 1
Section 60 of the Act makes provision for review by the Minister of certain decisions
of the Secretary under the Act (,,initial decisions), e.g. decisions to cancel the
registration or listing of goods from the Register.
Subsection 60(2) of the Act allows a ,,person whose interests are affected by an initial
decision to request the Minister to review such a decision within 90 days (see
amendments to this subsection being made by the items in Schedule 13 below).
As soon as is practicable after receiving such a request, the Minister must reconsider
the initial decision and either confirm the initial decision, or revoke it and substitute
her own decision (subsection 60(3) of the Act refers).
This item introduces new subsection 60(3C) to clarify that if the Minister revokes an
initial decision and makes a decision in substitution, the substituted decision:
(a) is taken to be a decision of the Secretary (except for the purposes of any
review of the substituted decision); and
(b) has effect, or is taken to have effect, on and from the date determined by the
Minister.
This amendment will support new section 25AAA and sections 25 and 25AA as
amended by the items in Schedule 6 above. In circumstances where the Minister
overturns a decision of the Secretary (or her delegate) for instance, not to register a
medicine in the Register, then because the Ministers decision is taken to be that of
the Secretary, the Secretary can then complete the process of registration (by
completing relevant administrative requirements in relation to the medicine under
section 25AAA of the Act and approving product information for the medicine under
section 25AA of the Act).
The reason that it is not taken to be a decision of the Secretary for the purposes of any
review of the substituted decision is to ensure that any person affected by the decision
can seek a review of the Ministers decision by the AAT (subsection 60(8) of the Act
refers).
41
Application
Item 2
This item sets out that the amendments to section 60 made by the above item apply in
relation to decisions revoked by the Minister on or after the commencement of this
item.
42
SCHEDULE 10 - Kits
Therapeutic Goods Act 1989
This Schedule contains amendments to the Act to modify the definition of a ,,kit in
section 7B of the Act, to encompass kits containing (among other things) only one
registered or listed therapeutic good, or a biological, rather than the current
requirement for a minimum of two separate therapeutic goods needing to be included.
Item 1
Section 7B of the Act sets out the requirements for a package and its contents to be
taken to be ,,kit for the purposes of the Act and the regulations. If they constitute a
kit within the meaning of section 7B, the package and its contents can be listed under
either section 26 or 26A of the Act.
Subsection 7B(1) of the Act currently provides that a package and therapeutic goods
in the package together constitute a kit for the purposes of the Act if:
the package and the therapeutic goods are for use as a unit;
each item of the therapeutic goods in the package are either registered or listed
or (in the case of a biological) included in the Register, or exempted from the
requirement to be entered on the Register; and
the package and therapeutic goods are not a composite pack or a system or
procedure pack.
Under this definition, for a package and therapeutic goods to be a kit there must be
more than one therapeutic good in the package. However there may be circumstances
where a package contains a number of items for use as a unit but only one of those is a
therapeutic good. As such it could not be listed as a ,,kit.
This item introduces a new subsection 7B(1) to the Act, with the effect that a package
and each of the therapeutic goods and non-therapeutic goods in the package together
constitute a kit provided that:
the package and each of the goods are for use as a unit;
at least one of the goods in the package is therapeutic goods (i.e. is a therapeutic
good);
each therapeutic good in the package is either registered, listed or included in
the Register, or exempt from entry on the Register; and
the package and goods are not a composite pack or a system or procedure pack.
This amendment will support greater flexibility in allowing kit sponsors to only have
one therapeutic good in their kits in order to access the listing process and make it
clear that kits may contain - in addition to therapeutic goods - products that are not
therapeutic goods (e.g. a shower cap, or a cosmetic such as a moisturiser) provided
they are for use as a unit.
43
Application
Item 2
This item sets out that the amendments to section 7B of the Act made by the item 1
apply in relation to applications for the listing of therapeutic goods made on or after
the commencement of this item.
44
SCHEDULE 11 - False or misleading statements
Therapeutic Goods Act 1989
Item 1
This Schedule contains amendments to the Act to include a new criminal offence
provision, and a corresponding civil penalty provision, relating to the making of a
statement that is false or misleading in a material particular in, or in connection with,
a request under section 9D of the Act for a variation to an entry for therapeutic goods
in the Register.
Criminal offences for false statements in variation requests
Section 9D of the Act allows the Secretary to vary an entry of therapeutic goods on
the Register in certain circumstances either on her own initiative, or upon a request by
the person in relation to whom goods are on the Register.
Requests to vary an entry on the Register may relate to a variety of matters, including
quite serious safety issues including adding warnings or precautions in connection
with the use of particular therapeutic goods. Variations can only be made in the
circumstances set out in the relevant subsection, including for instance, that the
Secretary is satisfied that the variation requested does not indicate any reduction in the
quality, safety or efficacy/performance of the goods for the purposes for which they
are to be used (subsections 9D(3), (3A) and (3D) of the Act refers).
Requests may also involve the provision of significant amounts of data, such as (in the
case of prescription medicines) clinical, pre-clinical or bioequivalence data necessary
for the Secretary to determine whether statutory requirements set out in the applicable
subsections in section 9D are satisfied such that the requested variation should be
made to the entry.
The provision of false or misleading information that was material to a decision by the
Secretary to vary an entry in the Register under the section could potentially have
serious consequences for public health. Currently, however, the Act does not contain
any offence or civil penalty provisions relating to the provision of false or misleading
information in connection with a request under section 9D.
The Act does, however, contain offences for the making of false or misleading
statements in relation to applications for marketing approval of therapeutic goods
(subsections 21A(1), (2), (3) and (4), and sections 22A, 32DO and 41FE refer).
To address this, item 1 introduces new section 9G to the Act in relation to making
statements in connection with a request to vary information on the Register. New
section 9G replicates the three-tiered offences structure with an alternative civil
penalty provision, contained under the Act for making a statement that is false or
misleading in a material particular in other circumstances where the Secretary relies
on information provided to make regulatory decisions (see for instance in subsections
21A(1), (2), (3) and (4) of the Act in relation to applications for listing in relation to
which certifications are given under section 26A of the Act, and section 22A of the
Act in relation to applications for registration under section 23 of the Act).
45
These offences would apply where false or misleading information has been given in
that context and:
either use of the relevant goods has resulted in, or will result in, harm or injury
to any person, or use of the goods, if used, would result in harm or injury to any
person - maximum penalty imprisonment for 5 years or 4,000 penalty units, or
both (new subsection 9G(1)); or
use of the goods, if used, would be likely to result in harm or injury to any
person - maximum penalty 2,000 penalty units (this is an offence of strict
liability) (new subsection 9G(2)); or
where there are no aggravating elements of harm or injury - maximum penalty
imprisonment for 12 months or 1,000 penalty units, or both (new subsection
9G(4)).
This tiered approach, with higher penalty levels applying where use of the goods has
had, or will or would have, serious health consequences, is consistent with the
existing tiered offences in the Act relating to the provision of false or misleading
information in connection with an application for marketing approval (subsections
21A(1), (2), (3) and (4), and sections 22A, 32DO and 41FE of the Act refer).
The maximum penalty levels for the three tiers of the new offence at 9G are higher
than the benchmarks set out in the Commonwealth document "A Guide to Framing
Commonwealth Offences, Civil Penalties and Enforcement Powers" (,,the Guide to
Framing Offices). However, these penalty levels are considered to be appropriate
and necessary to reflect the seriousness of the conduct to which they relate and the
potentially serious consequences for public health of such conduct. The penalty levels
are also consistent with the maximum penalties for the existing offences in the Act
mentioned above relating to the provision of false or misleading information in
connection with an application for marketing approval.
For example, the offence at new subsection 9G(1), for which a maximum penalty of 5
years imprisonment or 4,000 penalty units is specified, includes as a component of the
offence, in addition to the making of a false or misleading statement in connection
with a section 9D request, that the use of the goods to which the request relates has
resulted in a person suffering harm or injury or will or would (if used) result in a
person suffering harm or injury.
In addition, it is noted that the offence at new subsection 9G(2) is an offence of strict
liability (new subsection 9G(3) refers), and carries a higher maximum penalty than
suggested for strict liability offences in the Senate Standing Committee for the
Scrutiny of Bills Sixth Report of 2002 "Application of Absolute and Strict Liability
Offences in Commonwealth Legislation".
In relation to the concerns noted in that report about strict liability offences, and the
concerns set out in the Guide to Framing Offences for such offences, it is important to
note that new subsection 9G(2) does not incorporate any imprisonment element and
the maximum penalty is capped at 2,000 penalty units. This maximum penalty level
reflects the seriousness of the conduct addressed by the offence - this offence will
46
only apply where (among other components) use of the goods to which the relevant
section 9D request relates would be likely to result in harm or injury to a person.
As such, the strict liability offence at new subsection 9G(2), as with equivalent strict
liability offences throughout the Act that form part of the Acts tiered approach to
criminal offences, serves an important role in deterring and addressing conduct that
endangers public health.
New section 9H - Civil penalty for false statements in variation requests
Item 1 of this Schedule also introduces, in new section 9H, a corresponding civil
penalty provision to the above new offences for the provision of making a statement
that is false or misleading in a material particular in, or in connection with, a request
under section 9D.
The maximum civil penalty level under new section 9H is 5,000 penalty units for an
individual, and 50,000 penalty units for a body corporate.
This is consistent with the existing civil penalty provisions in the Act relating to the
provision of false or misleading information in connection with an application for
marketing approval (subsection 21B(1), and sections 22B, 32DP and 41FEA of the
Act refer), and with other civil penalty provisions in the Act.
As with the offences in new section 9G, the maximum penalty levels for new section
9H reflect the importance of deterring conduct involving the making of false or
misleading statements in requests to vary an entry in the Register.
If the Secretary were to approve a variation of an entry based on false or misleading
information (for example, information suggesting that the effect of a variation of the
product included in the Register will not result in any reduction in the quality, safety
or efficacy of that product), that could have serious consequences for users of the
product concerned.
Item 2
This item makes a consequential amendment to section 53A of the Act to include a
reference to new subsections 9G(1) and 9G(4) in a new item in the table in section
53A.
The effect of this amendment will be that if a jury acquits a person of the more serious
offence at subsection 9G(1) but is satisfied beyond reasonable doubt of facts that
prove the person is guilty of the lesser offence at subsection 9G(4), the jury may
convict the person of the offence at subsection 9G(4).
This amendment is consistent with the current position in relation to each of the
maximum penalty offence provisions relating to the provision of false or misleading
information in connection with an application for marketing approval (items 6, 10,
13G and 18 of the table in section 53A refer).
47
Application
Item 3
This item sets out that the amendments above to introduce new sections 9D and 9H to
the Act apply in relation to requests under section 9D of the Act made on or after the
commencement of this item.
48
SCHEDULE 12 - Notice of cancellation of registration or listing
Therapeutic Goods Act 1989
This Schedule amends subsection 30(5) of the Act to provide a minimum notice
period of at least 20 working days before a cancellation of therapeutic goods from the
Register in relation to which the Secretary is required to give notice, may take effect.
Item 1
Currently under subsection 30(5) of the Act, where the Secretary cancels the
registration or listing of a therapeutic good from the Register, the goods cease to be
listed:
(a) if the cancellation has been done under subsection 30(1), (1A) or (1C) (each of
which enable the Secretary to cancel without first giving notice of a proposal
to cancel) - on the day on which the notice of cancellation is given to the
sponsor of the goods; or
(b) in any other case - on such later day as is specified in the notice.
This item includes a new paragraph 30(5)(b) to the Act to give sponsors of goods
cancelled other than under subsections 30(1), (1A) or (1C) at least 20 working days
from the date of the notice of cancellation before the cancellation of their goods will
take effect.
The cancellations to which the new paragraph applies are those made by the Secretary
under subsection 30(2) of the Act in relation to which the Secretary is required to give
the sponsor notice of a proposal to cancel and the opportunity to make submissions in
response (subsection 30(3) of the Act refers). This does not include cancellations
where it appears to the Secretary that failure to cancel would create an imminent risk
of death, serious illness or serious injury (paragraph 30(1)(a) of the Act refers) or
whether the cancellation is of a medicine listed under subsection 26A of the Act
which was in fact ineligible for listing (subsection 30(1A) of the Act refers).
The effect of this measure is to provide such sponsors with a known period of time to
make necessary arrangements for removing products from the marketplace following
a cancellation of their goods from the Register. This amendment will bring
subsection 30(5) of the Act into line with the arrangements under the Act for the
cancellation of medical devices (section 41GQ of the Act refers).
Application
Item 2
This item sets out that the amendments to subsection 30(5) of the Act made by item 1
above apply in relation to proposed cancellations of which a person is informed under
subsection 30(3) of the Act on or after the commencement of this item, whether the
circumstances giving rise to the proposed cancellation occurred before, or occur after,
that commencement.
49
SCHEDULE 13 - Publication
Therapeutic Goods Act 1989
This Schedule contains amendments to the Act to require the Secretary to publish in
the Gazette or on the Departments website a notice setting out the particulars of the
cancellation of any registered or listed therapeutic goods from the Register under
section 30 of the Act. The Schedule also amends section 60 of the Act to clarify when
the 90 day period commences in which a request for merits review of an initial
decision must be made by a person who is not a sponsor of a therapeutic good, and
amends a number of provisions in the Act that require or authorise the Secretary to
publish information in the Gazette, to allow the Secretary at her discretion to publish
that information in the Gazette or on the Departments website.
Item 1
This item makes a minor consequential change to subsection 9A(6) of the Act, to
reflect that item 4 below amends (among other provisions) subsection 9A(5) of the
Act to permit the Minister to publish notices under subsection 9A(5) either in the
Gazette or on the Departments website.
The notices referred to are notices in which the Minister, under subsection 9A(5) of
the Act, requires that specified therapeutic goods be included in the part of the
Register for listed goods. Currently under subsection 9A(5) of the Act, the Minister
must publish such notices in the Gazette.
Item 2
This item introduces a new section 30B to the Act, the effect of which is to require the
Secretary to publish the particulars of any cancellation of registered or listed
therapeutic goods by her under section 30 of the Act either in the Gazette or on the
Departments website.
This amendment will bring the Secretarys obligations in relation to these
cancellations into line with the Secretarys obligations in relation to the cancellation
of biologicals and medical devices. The Act currently requires the Secretary to
publish the details of any cancellation of biologicals and kinds of medical devices
from the Register (sections 32GE and 41GP of the Act refer).
Item 3
Subsection 60(2) of the Act currently sets out that a person whose interests are
affected by an initial decision may, by written notice, request the Minister to review
that decision. Paragraphs 60(2)(a) and (b) set out the time periods within which such
a request must be made:
(a) in the case of a decision particulars of which are required to be notified in the
Gazette - within 90 days after those particulars are so notified; and
(b) in any other case - within 90 days after the decision first comes to the persons
notice.
50
This item introduces a new subsection 60(2) to the Act, which has the effect of setting
out that a person whose interests are affected by an initial decision may request the
Minister to reconsider that decision:
(a) if the Act requires the person to be given written notice of the decision or
particulars of the decision - within 90 days after the notice is given to the
person;
(b) otherwise - within 90 days of the earlier of when the notice or particulars of
the decision are published, or the decision first comes to the persons attention.
This amendment is related to the amendments to the Act made by item 4 below which
provide the Secretary with the option of publishing information on the Departments
website instead of in the Gazette, including in relation to the publication of particulars
of a range of regulatory decisions.
New subsection 60(2) also has the effect of indicating that, in the case of a decision in
relation to which the Secretary is required to give notice in writing to a person, the 90
days for the person to ask the Minister to undertake a review commences from when
notice is given to the person. This replaces the current provision for that period to
commence from when the decision first comes to the persons notice.
This change is designed to avoid situations whereby a person might argue years after
a regulatory decision has been made that their right to seek the Ministers review of a
decision remained open because the person had only just become aware of the initial
decision.
The outcome is that under the revised subsection 60(2):
in the case of a person to whom an ,,initial decision within the meaning of
subsection 60(1) of the Act (in relation to which a review by the Minister is
conferred under the section) is notified by the Secretary, the person will have
90 days from notification to make request a reconsideration of the decision;
in the case of any other person whose interests are affected by the initial
decision, the person will have 90 days from the earlier of publication of notice
of the decision in the Gazette or on the Departments website, or the decision
first coming to the persons notice.
There is a public interest in having certainty and finality about rights of review for
those about whom regulatory decisions are made and third parties whose interests
may be affected by such decisions.
Item 4
This item amends almost all provisions in the Act that currently require, or authorise,
the Secretary to publish information or the particulars of regulatory decisions in the
Gazette, to give the Secretary the option of publishing on the Departments website
instead.
The provisions in the Act that are not proposed to be amended are those which:
require the Secretary to publish in the Gazette particulars of exemptions by the
Minister of therapeutic goods from the requirement to entered on the Register so
51
that the goods can be made available urgently in Australia to deal with an actual
threat to public health caused by an emergency that has occurred, and
revocations and variations of such exemptions (subsections 18A(10), 32CF(1)
and 41GW(1) of the Act refer);
require the Secretary to publish in the Gazette particulars of decisions by her to
require a person to recover batches of therapeutic goods which have been
exempted from registration or listing in the Register or, in the case of
biologicals, from inclusion in the Register, in order either for the goods to be
stockpiled to create a readiness for an emergency or for use to deal with an
emergency that has occurred, because the goods in that batch do not conform to
an applicable standard or are otherwise not fit for their intended purpose
(subsections 30F(4) and 32CJ(4) of the Act refer); and
permit the Secretary to make orders, published in the Gazette, determining that
groups of certain kinds of therapeutic goods identified in the order are gazetted
therapeutic goods groups (subsection 16(2) of the Act refers).
Providing the Secretary with the option of publishing information on the
Departments website rather than in the Gazette (noting that the TGA is a division of
the Department and the TGA has a departmental website at www.tga.gov.au) will be
an easier, and more familiar, way of accessing this information for the public than
through the Gazette.
Examples of the kinds of information that will be able to be published on the
Departments website include details of the suspension and cancellation of the various
kinds of therapeutic goods (i.e. registered and listed medicines and other therapeutic
goods (new section 30B - item 2 above refers), biologicals (section 32GE of the Act
refers) and medical devices (section 41GP of the Act refers), the revocation or
suspension of manufacturing licences (subsection 41(6) of the Act refers), and details
of requirements imposed by the Secretary on a person who has supplied therapeutic
goods which the Secretary is satisfied have been (or could possibly have been)
subjected to tampering (subsection 42V(4) of the Act refers).
No change is being made in relation to the publication of orders relating to ,,gazetted
groups in subsections 16(2), (3) and (3A) of the Act which will continue to be
published only in the Gazette.
Item 5
Item 5 amends the headings for a number of subsections of the Act amended by item
4 above, to remove the reference in those headings to the Gazette, in order to reflect
that those provisions now provide for publication of relevant information either in the
Gazette or on the Departments website.
Application
Item 6
This item provides that the amendments made by this Schedule that relate to the
publication of information on the Departments website apply in relation to matters
the subject of those provisions that occur on or after the commencement of this item.
52
Item 7
This item provides that the amendments to section 60 of the Act made by item 3 apply
in relation to initial decisions (as defined in subsection 60(1) of the Act) made on or
after the commencement of this item.
53
SCHEDULE 14 - Public notification and recovery
Therapeutic Goods Act 1989
This Schedule contains amendments to provisions in the Act relating to the public
notification and/or recovery of registered or listed therapeutic goods, biologicals and
medical devices (sections 30EA, 32HA and 41KA of the Act, respectively) to broaden
the dissemination of information requirements the Secretary may impose on a sponsor
or supplier under those provisions. The Schedule also amends the Act to allow the
Secretary to require persons to whom those provisions apply to give her information
about persons to whom their goods were supplied.
Items 1 and 2
Under section 30EA of the Act, the Secretary can impose requirements on specified
persons in relation to the public notification and/or recovery (i.e. recall) of registered
or listed therapeutic goods (or goods that are exempt from, or are the subject of an
approval or authority in relation to, the requirement to be registered or listed) where
certain specified circumstances exist in relation to those goods. In particular, the
Secretary can under subsection 30EA(2) impose on a person mentioned in column 3
of the table in subsection 30EA(1) requirements relating to therapeutic goods if any of
the circumstances set out in column 2 of the table apply.
The specified circumstances set out in column 2 of the table in subsection 30EA(1)
include the following:
the goods are in the Register, but are supplied when they do not conform to an
applicable standard or the manufacturing principles have not been observed in
relation to their manufacture;
the goods are exempt from the requirement to be in the Register or are the
subject of an approval or an authority with the effect that they are approved for
supply while not being in the Register, but they have been supplied while not
conforming to an applicable standard or the manufacturing principles have not
been observed in relation to their manufacture;
the goods are supplied in breach of the offence provisions in section 19B (e.g.
being not exempt, they are imported or supplied while not in the Register or
otherwise approved from supply) or are counterfeit;
the goods are in the Register but it appears to the Secretary that their safety,
quality or efficacy, or presentation, is unacceptable;
one of more steps in the manufacture of the goods has been carried out by an
unlicensed manufacturer; and
the goods are supplied while their registration or listing is suspended or has
been cancelled.
The requirements are set out in subsection 30EA(2) of the Act.
Items 1 and 2 amend subsection 30EA(2) to include powers for the Secretary to
require persons mentioned in the table in subsection 30EA(1) in relation to each of the
circumstances referred to above (usually the sponsor of the relevant goods) to:
54
inform the public, or specified persons, about specified information regarding
therapeutic goods and the circumstances set out in the table, e.g. about the
circumstances in which the goods were cancelled or information about the basis
on which the Secretary has come to a view that the safety of the goods is
unacceptable (item 1 refers); and
give the Secretary specified information about the persons to whom the
therapeutic goods in question have been supplied (item 2 refers).
This will clarify the powers the Secretary currently has under that subsection and
ensure that relevant information can be provided directly by the sponsor to health care
professionals, patients and consumers about the goods. The Secretary does have the
power under paragraph 30EA(2)(b) of the Act to inform the public of the fact that
circumstances mentioned in the table under subsection 30EA(1) have occurred.
However, the information that may be needed to be communicated in order to fully
inform the public or specified persons (e.g. patients using a particular medicine) about
a problem may go beyond the scope of just advising that the specified circumstances
(such as the fact that the product has been cancelled from the Register) has occurred.
It should be noted that the Secretary also has a range of powers under section 61 of
the Act to release information to the public about decisions made about therapeutic
goods and the safe use of therapeutic goods.
It is also important that the Secretary have the ability to require the sponsor or
supplier (e.g. where the goods are counterfeit) of goods to provide her with
information about who relevant goods have been supplied to, so that patients who
may be at risk can be quickly identified and contacted.
Items 3 and 4
Items 3 and 4 makes equivalent amendments to items 1 and 2 above to subsection
32HA(2) of the Act in relation to the Secretarys power to impose requirements on
specified persons in relation to the public notification and recovery of biologicals.
Item 5
Item 5 makes a minor consequential amendment to subsection 41KA(2) of the Act to
accommodate the changes set out in item 6 below.
Item 6
Item 6 adds to new subparagraphs (c) - (d) to subsection 41KA(2) of the Act in order
principally to make equivalent amendments to items 1 and 2, and items 3 and 4 above,
to subsection 41KA(2) of the Act, regarding the Secretarys power to impose
requirements on specified persons in relation to the public notification and recovery of
kinds of medical devices.
The effect of these amendments to section 41KA is that the Secretary will be able to
ensure that relevant information is provided by a sponsor to the public, relevant health
care professionals and patients where for instance, an implantable medical device is
cancelled from the Register after reports of safety concerns. The requirement to
provide information to the Secretary about persons to whom the device has been
supplied will assist the TGA to facilitate the appropriate dissemination of material
about the device.
55
Item 6 also includes the power for the Secretary to require persons specified in the
table under subsection 41KA(1) of the Act to publish specified information relating to
the manufacture or distribution of medical devices in relation to which the person is
either the sponsor or supplier. This brings the Secretarys powers in relation to
medical devices into line with those currently available to her under subsection
30EA(2) of the Act in relation to registered and listed goods and under subsection
32HA(2) of the Act in relation to biologicals.
Application
Item 6
Sub-item (1) provides that the amendments to section 30EA of the Act made by items
1 and 2 apply in relation to requirements imposed by the Secretary under subsection
30EA(2) of the Act on or after the commencement of this item, whether the goods to
which the requirement relates are registered or listed before or after that
commencement.
Sub-item (2) provides that the amendments to section 32HA of the Act made by items
3 and 4 apply in relation to requirements imposed by the Secretary under subsection
32HA(2) of the Act on or after the commencement of this item, whether the biological
to which the requirement relates is included in the Register before or after that
commencement.
Sub-item (3) provides that the amendments to section 41KA of the Act made by items
5 and 6 apply in relation to requirements imposed by the Secretary under subsection
41KA(2) of the Act on or after the commencement of this item, whether the kind of
medical device to which the requirement relates is included in the Register before or
after that commencement.
56
SCHEDULE 15 - Failure to comply with requirements to provide information
etc.
Therapeutic Goods Act 1989
This Schedule amends subsection 30(2) of the Act to allow Secretary to cancel the
registration or listing of a product where the sponsor of the goods has failed to
respond to a notice to provide information or documents issued under section 31 of
the Act within 14 days after the date specified in the notice for production of the
material. The Schedule also amends the Act to state that the offences in the Act
relating to failing to comply with a notice issued by the Secretary to provide
information or documents about biologicals or medical devices (sections 32JB and
41JB of the Act) will not apply if the person issued the notice had a reasonable
excuse.
Item 1
Subsection 30(2) of the Act sets out a number of circumstances in which the Secretary
may, subject to the requirements of subsection 30(3) of the Act, cancel the registration
or listing of therapeutic goods.
Currently, however, the grounds of cancellation in subsection 30(2) do not include
where a person in relation to whom therapeutic goods are registered or listed has been
issued a notice to provide information to the Secretary under section 31 of the Act, but
has not responded.
Subsection 30(1C) of the Act, however, does set out a power for the Secretary to
cancel from the Register without notice a medicine listed under section 26A of the
Act where the person in relation to whom the product is listed (the sponsor) has failed
to comply with a section 31 notice within 20 working days (if that notice was issued
to ascertain whether the certifications made in relation to the listing of the medicine
under sections 26A(2) and (2A) were correct - item 1 of Schedule 2 refers).
There is currently an inconsistency in the legislation in that the Secretary does not
have the power to cancel a product from the register if the sponsor fails to respond to
a section 31 notice in relation to registered goods or goods listed under section 26 of
the Act (the latter are mainly export only goods and therapeutic devices).
This item amends subsection 30(2) of the Act to address this inconsistency, with the
effect that the Secretarys power to cancel for a failure to respond to a section 31
request for information or documents will apply in respect of all registered or listed
goods and not, as currently, only in relation to medicines listed under section 26A of
the Act. Such a power is vital to underpin the integrity of the regulatory regime - the
section 31 request may relate to safety issues for a medicine currently in the
Australian market about which it is vital that the Secretary is able to obtain
information from the sponsor.
While it is an offence to fail to comply with such a notice (subsection 31(4) of the
Act), the possibility of a product being cancelled from the Register (with the effect
that, once cancelled, it would be unlawful to supply the product in Australia) will
57
provide an additional commercial incentive for the sponsor to comply with the request
in a timely way.
This power to cancel will apply if the person has not complied with the notice within
14 days after the end of the period of time specified in the section 31 notice (e.g. if the
notice states that the person has 28 days to comply with the notice, the Secretary
could only cancel the goods from the Register if no response was received at the end
of 42 days).
As with the other cancellation powers of the Secretary under subsection 30(2) of the
Act, the Secretary is required under subsection 30(3) to first issue an affected person
notice of a proposal to cancel and give them a reasonable opportunity to make
submissions in relation to the proposal. If the person makes submissions, the
Secretary must not make a decision on cancellation until those submissions have been
taken into account.
As a result of including failure to respond to a request to provide information as a
grounds for cancellation of listed or registered therapeutic goods from the Register,
the Secretary has the option under section 29D of the Act of suspending the goods
from the Register for a period of not more than 6 months.
Item 2
This item amends section 32JB of the Act to include (at new subsection 32JB(1A)) a
defence of reasonable excuse to the offence set out in subsection 32JB(1) for failing to
comply with a notice issued by the Secretary under section 32JA of the Act.
Section 32JA of the Act sets out that the Secretary may require a person in relation to
whom a biological is or was, at any time within the previous 5 years, included in the
Register, or an applicant for the inclusion of a biological in the Register, to give her
information or documents relating to any of the matters listed in paragraphs
32JA(1)(a)-(p).
Subsection 32JB(1) of the Act sets out that a person commits an offence if they have
been given a notice under section 32JA and have failed to comply with that notice (the
maximum penalty is 500 penalty units). New subsection 32JB(1A) provides that the
offence at subsection 32JB(1) does not apply where the person who was issued the
notice has a reasonable excuse.
Including a defence of reasonable excuse in relation to the offence at subsection
32JB(1) will bring this offence for biologicals into line with the equivalent offence in
relation to registered or listed goods (subsection 31(4A) of the Act refers).
New subsection 32JB(1A) sets out that the defendant will bear an evidential burden in
relation to making out the defence.
Not only is this consistent with the reasonable excuse defence at subsection 31(4A) of
the Act for registered and listed goods, it is appropriate as it reflects the fact that it
would be significantly more difficult and costly for the prosecution to in effect prove
a negative - i.e. that there was no reasonable excuse for a defendant - as the matters
58
that might comprise a reasonable excuse would in most cases be peculiarly within the
knowledge of the defendant.
Item 3
This item makes an equivalent amendment to item 2 above to section 41JB of the Act,
in relation to medical devices, to include a defence of reasonable excuse to the offence
set out at subsection 41JB(3) of the Act for failing to comply with a notice to provide
information or documents issued by the Secretary under 41JA of the Act.
Application
Item 4
Sub-item (1) provides that the amendments to section 30 of the Act made by item 1
apply in relation to notices given under section 31 of the Act on or after the
commencement of this item. This is the case whether:
for a notice given to an applicant for registration or listing - the application is
made before or after that commencement, or
for a sponsor or previous sponsor - whether their goods were included in the
Register before or after that commencement.
Sub-item (2) provides that the amendments to section 32JB of the Act made by item 2
apply in relation to notices given by the Secretary under section 32JA of the Act on or
after the commencement of this item.
Sub-item (3) provides that the amendments to section 41JB of the Act made by item 3
apply in relation to notices given by the Secretary under section 41JA of the Act on or
after the commencement of this item.
59
SCHEDULE 16 - Information
Therapeutic Goods Act 1989
This Schedule amends sections 9D (requests by sponsors to vary existing entries in
the Register for therapeutic goods) and 23 of the Act (applications for the registration
or listing of goods in the Register) to enable the Secretary to, by legislative
instrument, specify kinds of information that must accompany section 23 applications
and certain section 9D requests.
Items 1 and 2
Section 23 of the Act sets out the procedures and requirements relating to applying for
the registration or listing of therapeutic goods in the Register.
Subsection 23(2) of the Act currently provides that an application will not be effective
unless a number of steps have been complied with including, at paragraph 23(2)(b), if
the applicant has delivered to the relevant office:
such information, in a form approved, in writing, by the Secretary, as will
allow the determination of the matter.
Applications under section 23 of the Act cover a range of different kinds of goods, for
example, prescription medicines, over-the-counter medicines, ,,complementary
medicines and medicines for which listing under section 26 of the Act is sought
including ,,export only medicines.
Depending on the goods involved, different kinds and amounts of information may be
needed to enable the Secretary to assess such applications for registration or listing.
As such, it is important that the Secretary is able to specify the kinds of information
that must accompany section 23 applications for the various types of therapeutic
goods.
Item 2 sets out amendments that achieve that effect, by requiring in a new paragraph
23(2)(b) that an application must be accompanied by such information as will allow
the determination of an application, and which is information of the kind specified in
a legislative instrument made for the purposes of new paragraph 23(2)(b)
Item 1 makes the same kind of amendments to item 2 above to section 9D of the Act,
in relation to the Secretarys ability to require that different kinds of information
(again, with a power for the Secretary to make a legislative instrument specifying
relevant kinds of information) must accompany requests under that section from
persons in relation to whom goods are included in the Register to vary the entry of
those goods in the Register, depending on the nature of the goods and the kind
request.
60
Application
Item 3
Sub-item (1) provides that the amendments to section 9D of the Act made by item 1
apply in relation to requests made under that section made on or after commencement
of this item.
Sub-item (2) provides that the amendments to section 23 of the Act made by item 2
apply in relation to applications for the registration or listing of therapeutic goods
made on or after the commencement of this item.
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