Several issues were raised by submitters about the proposed bill, and
the remainder of this report addresses several of these.
The current situation
The Therapeutic Goods Act contains complex provisions that govern the listing
and registering of goods. These provisions cover a range of conditions and
procedures that need to be followed, and requirements that goods have to meet,
relating to things like safety or product information.
One criterion that therapeutic goods must meet relates to presentation.
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 precise standard of presentation that a good must meet in order to
be placed on the Register depends on the category into which it falls. For registered
goods, the presentation must be 'acceptable'.
For the category of listed goods, for those listed under section 26 of
the Act, the secretary cannot refuse listing unless the presentation is
The process is slightly different for medicines being listed under section 26A
of the Act, in which cases the presentation of the medicine must be 'not
Section 3(5) of the Act defines 'unacceptable' presentation:
For the purposes of this Act, the presentation of therapeutic
goods is unacceptable if it is capable of being misleading or confusing as to
the content or proper use or identification of the goods and, without limiting
the previous words in this subsection, the presentation of therapeutic goods is
(a) if it states or suggests that the goods have ingredients,
components or characteristics that they do not have; or
(b) if a name applied to the goods is the same as the name
applied to other therapeutic goods that are supplied in Australia where those
other goods contain additional or different therapeutically active ingredients;
(c) if the label of the goods does not declare the presence
of a therapeutically active ingredient; or
(ca) if the therapeutic goods are medicine included in a
class of medicine prescribed by the regulations for the purposes of this
paragraph—if the medicine’s label does not contain the advisory statements
specified under subsection (5A) in relation to the medicine; or
(d) if a form of presentation of the goods may lead to unsafe
use of the goods or suggests a purpose that is not in accordance with
conditions applicable to the supply of the goods in Australia; or
(e) in prescribed cases.
While the Act defines 'unacceptable', it does not define 'not
acceptable', which the committee understands has a different meaning. The
Explanatory Memorandum comments on this in the context of the presentation of
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.
Just as sections 25 and 26 of the Act create procedures for the
registering or listing of products,
Section 30 of the Act establishes the procedure by which therapeutic goods can
be cancelled from the Register. Section 30 is complex, but the main provisions
relevant to this discussion about cancellation are in subsection 30(2):
(2) Subject to subsection (3), the Secretary may, by notice
in writing given to a person in relation to whom therapeutic goods are included
in the Register, cancel the registration or listing of the goods if:
(a) it appears to the Secretary
that the quality, safety or efficacy of the goods is unacceptable; or
(b) the goods have changed so that
they have become separate and distinct from the goods as so included; or
(ba) in the case of a medicine
listed under section 26A, it appears to the Secretary that any of the
certifications under paragraph 26A(2)(b), (c), (d), (f), (fa), (fb), (fc), (h),
(i), (j) or (k) or subsection 26A(2A) are incorrect; or
(c) the sponsor has refused or
failed to comply with a condition to which the inclusion of the goods is
subject (other than the condition under paragraph 28(5)(d)); or
(ca) the person has contravened
subsection 29A(1) or 29AA(1) in relation to the goods; or
(d) the goods become required to
be included in the other part of the Register; or
(e) the goods do not conform to a
standard applicable to the goods or to a requirement relating to advertising
applicable to the goods under Part 5‑1
or under the regulations; or
(f) the annual registration or
listing charge is not paid within 28 days after it becomes payable.
Notably, this list does not contain a reference to the presentation of
goods. Thus, while under section 30 of the Act the Secretary may cancel the
registration or listing of therapeutic goods for a number of reasons, there is
currently no provision for the registration or listing of therapeutic goods to
be cancelled by the Secretary on the basis that the presentation has become
deficient in some way.
The proposed legislation seeks to amend subsection 30(2), to add to the
grounds on which goods may be cancelled, so that the Secretary may 'cancel the
registration or listing of the goods if':
it appears to the Secretary that the presentation of the
in the case of registered goods—is
not acceptable; or
In the case of listed goods—is
Under the proposed legislation this would mean that the Secretary could,
after giving written notice of a proposal to cancel and considering any
submissions made by a sponsor in relation to that proposal, cancel goods from
the Register if the presentation of registered medicines or biologicals is not
(i.e. no longer) acceptable, or if complementary and export-only medicines are
In the departmental submission and government explanatory memorandum it
was explained that the inclusion of this new power would:
- 'ensure that there is a mechanism by which therapeutic goods
continue to satisfy [the presentation requirements] for so long as they remain
entered on the Register'
rather than having to satisfy them only at the point of application (and
thereby filling a gap in the Act), and
- ensure 'that those using a medicine are not misled about its use
or characteristics or confuse it with other medicines after it has been
included in the register'.
The existing Act has a mechanism by which biologicals can be cancelled
if there are problems with presentation;
the amendment would create a parallel mechanism for other regulated goods.
Medicines Australia, while supportive of ensuring effective enforcement
powers, was concerned about the interaction between the current reforms and
possible outcomes from the packaging and labelling review that is still
The packaging and labelling review:
is primarily concerned with the presentation of the
information on the medicine containers or on the boxes within which they are
supplied. Of particular interest are the visual aspects that contribute to the
usability of the information provided and facilitate the safe use of the
medicine by health care professionals and consumers.
Medicines Australia expressed concern at the potential impact of the
review on the interpretation of 'acceptable presentation' and was 'cautious'
with respect to the power of the Secretary to 'deregister products based on a
potentially uncertain or changing requirement for presentation.'
The GMiA also expressed concerns stating:
GMiA is concerned that an unintended consequence of the
amendment in this Bill may be that the Secretary is able to suspend/cancel
medicines from the ARTG that do not meet the, as yet undetermined, requirements
mandated as a result of the TGA labelling and packaging review.
Mr Kentwell had a different concern, querying the distinction for the
two classes of goods:
The bottom line is that if legislative guidance is afforded
to goods that are subject to less regulatory scrutiny such as low risk listed
medicines[,] by what justification should those higher risk registered goods
not be afforded similar guidance. For registered goods the “range of factors
that might go beyond the scope of the definition of ‘unacceptable
presentation’” in my view should not be open-ended but codified at least to the
same extent as it has for listed goods.
In its response the department indicated that Mr Kentwell's submission
may have misunderstood the way the amendment is intended to operate:
This reference was not intended to imply that the matters set
out in subsection 3(5) of the TG Act would not be relevant in considering
whether the presentation of registered goods may be 'not acceptable'. Rather,
this reference sets out that such matters would (where applicable) be relevant
in understanding the meaning of 'not acceptable', but that there could also be
other factors or circumstances (in addition to those in subsection 3(5)) in
which the presentation of registered goods may not be acceptable. Such
additional circumstances may relate to matters particular to registered
medicines, such as the presentation of product information or consumer medicine
On the relationship between the amendments and the review currently
underway, the department stated that the amendments relating to presentation,
as per Schedule 7 of the Bill:
...do not relate to, or pre-empt the outcomes of the TGA's
Labelling and Packaging Review...the proposed new power would not be necessary
for or related to, the enforcing of any new labelling and packaging
requirements as these are expected to be implemented using a different
The department indicated that it anticipates that the pending labelling
and packaging reforms will be 'implemented through the making or amending of a
standard for relevant therapeutic goods under section 10' of the Act.
As such an application for registration or listing of a therapeutic good would,
as is currently required, need to comply with the applicable standards in
relation to labelling and packaging in addition to and separately from
requirements relating to presentation. The power to suspend or cancel a good
from the Register for breach of or non-compliance with a standard is and would
continue to be separate from the power to suspend or cancel a good because of
non-compliance with presentation requirements.
The department also indicated that any amendments to the standards as a result
of the labelling and packaging review 'would be the subject of consultation.'
The committee is supportive of the policy objective reflected in the
proposed amendment. The committee understands the concern of some submitters,
and found the provisions of the existing legislation and the proposed amendment
difficult to navigate. There are several overlapping reasons that make the
operation of these sections difficult to interpret:
- The construction of section 25 in the positive, but section 26 in
- The fact that 'acceptable' and 'unacceptable' do not mean the
exact opposite of each other; and
- The fact that 'unacceptable' and 'not acceptable' do not have the
On balance, the committee is satisfied that the amendments will achieve
an important policy objective. The committee suggests that, in the course of
the broader review of the Act, the government consider simplification of the
legislation, by changes such as framing sections 25 and 26 in the same form, or
considering removal of the distinction between unacceptable and not acceptable.
New ministerial power: proposed section 7AA
The current definition of 'therapeutic goods' has the potential 'to
extend to a wide range of goods that may not have been intended to be regulated
under the Act'.
For example, the making of a claim that goods have a health benefit may
potentially subject them to regulation under the Act, even if no public health
risk is likely. There might also be goods (for instance food about which low
level health claims are made) that fall within the scope of the Therapeutic
Goods Act, but which are more appropriately regulated under other existing
Whilst it is currently possible to exempt goods from certain
requirements under the Act, 'it is not possible to entirely exclude such
products from the regulatory scheme for therapeutic goods'.
Currently section 7 of the Act provides the Secretary with the
administrative power to determine whether certain products are, or are not,
therapeutic goods. The Secretary is required to base the decision on the
definition of 'therapeutic goods' as found in subsection 3(1) of the Act. The
section does not allow the Secretary to cancel goods from the Register, and
decisions under the section are reviewable by the Minister and the
Administrative Appeals Tribunal.
The power of the Secretary under section 7 is constrained in two
respects. First, the Secretary can only act to exclude a product if satisfied
that it does not meet the definition of therapeutic goods in the Act. That
definition is extremely broad. It may capture things that were never intended
to be regulated as therapeutic goods, but the legislation does not allow the
Secretary to consider the intention of the Act or the consequences of a product
being regulated under the Act. Second, the Secretary must be 'satisfied' that a
product is not therapeutic goods. In the absence of sufficient information for
the Secretary to satisfy herself one way or the other, she cannot reach a
conclusion and cannot proceed to make a determination.
The power under section 7 is therefore limited. Proposed section 7AA
of the Act would enable the Minister, by way of disallowable legislative
instrument, to exercise a broader judgement than that available to the
Secretary, and determine that goods should be excluded altogether from the scope
of the regulatory scheme in the Act.
In its submission to the committee the department stated that the new
...would ensure that the focus of regulation under the Act
remains directed at goods that have some impact on public health, and that the
resources of the Therapeutic Goods Administration are more appropriately
directed at the regulation of therapeutic goods and not household items,
jewellery and a range of other goods in relation to which therapeutic claims
may be made. The proper focus of regulation under the Act should be directed at
products which could potentially represent a health risk to the Australian
The committee asked the department to respond to issues raised by
submitters regarding the purpose of the new provision. The department
The primary reason for inserting this provision is to address
the increasingly common practice for therapeutic claims to be made for a range
of goods (perhaps to make them more appealing to health conscious consumers),
even if they have no or little bearing on actually preventing, or alleviating
any illness or injury, or any other health-related impact, with the result that
these goods become subject to regulation under the TG Act.
Mr Kentwell queried the necessity of introducing proposed section 7AA.
He expressed concern that decisions under the new section would not be subject
to merits review. He observed:
This provides the regulator with the option of utilising this
mechanism if fearful of defeat via merits review...it begs the question as to
why, notwithstanding the manner in which the EM describes the justification,
such an additional power is necessary other than to provide an alternative
mechanism more insulated from scrutiny than sponsor initiated merits review.
Concerns were expressed by CHC that there is no criteria for excluding
goods by means of a determination under proposed section 7AA:
The CHC’s concern is that there is no boundary to what the
Minister can exclude from the Register and the definition of what may be
excluded is incongruous.
It felt that the effective expansion of the Ministers powers could
possibly mean that certain complementary medicines could be adversely affected:
...if genuine therapeutic products were to be excluded
following the expansion of the Ministers powers, this would be an unintended
consequence causing very real concern for the complementary medicines industry.
There was also concern that the proposed legislation contained no
requirement for consultation with industry prior to a determination being made.
Some felt that this meant that there would be no opportunity for the sponsor of
products that may be excluded under this power to defend their position:
...there appears to be no comparable requirement for an
affected party to be consulted prior to the Minister declaring a good not to be
a therapeutic good under a determination in 7AA(1) or (2). Although this
determination would be made via legislative instrument, the disallowance period
does not amount to meaningful industry consultation. In the interests of a
consultative approach to regulation, Medicines Australia supports industry
consultation prior to determinations that affect members’ interests.
Under the new power there is no defence against the removal
of a product from the definition of a therapeutic good – if the decision can be
made regardless of whether the Minister believes that a product is a
therapeutic good or not.
In contrast ADIA felt that the disallowable nature of the determination
...ADIA is confident in the fact that such a determination
would be required to be tabled before Parliament and would be disallowable,
providing an appropriate safeguard in the case of an egregious decision by the
The committee asked the department to respond to issues raised by
submitters, including Mr Kentwell. The department's response to Mr Kentwell's
queries about section 7 drew attention to the limitations of the Secretary's
To clarify, section 7 of the TG Act allows the Secretary to
confirm by way of determination that goods are not therapeutic goods. It is
predicated on the Secretary being satisfied that the goods are not in fact
therapeutic goods. If there is insufficient material on which she could come to
that view then no determination can be made. Section 7AA allows the Minister to
declare that products are not therapeutic goods whether or not they come within
the definition of therapeutic goods. The kinds of products in relation to which
the Minister might make a determination would not be ones that in order to be
supplied safely in Australia, require regulation of the kind found in the TG
The department in their response to CMC indicated that Minister will
operate on a 'case-by-case basis' and 'take into account all relevant factors
for the product in question'
when considering whether to exclude products from regulation under the Act,
- whether the product is of a kind that has the potential to harm a
- whether the application of the regulatory requirements under the Act
that are designed to test the safety, quality, efficacy and performance of a
product for it to be supplied in Australia would be appropriate to a product of
that kind; and
- whether the kinds of risks to which the public might be exposed from the
supply of the product (for instance, unsupported therapeutic claims) can be
more effectively managed under other Commonwealth or state and territory laws.
The department went on to indicate the kinds of goods that could be
excluded under such a determination:
Examples of goods that may well be inappropriate for
regulation under the TG Act regulatory scheme include household items such as
mattresses, and jewellery and clothing, for which therapeutic claims are made,
and in relation to which none of the current exceptions to the definition of
'therapeutic goods' apply.
The department also indicated that the new power cannot be used:
- to expand the range of goods coming within the definition of
to take a therapeutic good that should be cancelled (for whatever
reason) outside the regulatory regime;
- to exclude products such as prescription, over-the-counter and
complementary medicines which are clearly appropriate for regulation under the
and noted that determinations made by the Minister would be
subject to parliamentary review through the disallowance process.
On the issue of what consultations would be associated with proposed
section 7AA, in their response the department indicated that:
Consultation is likely to be undertaken before any exercise
of the new power in proposed section 7AA, for example with sponsors and
suppliers or products that are proposed to be excluded, as well as with
consumer representative bodies. The Legislative lnstruments Act 2003
(the LI Act) sets out various requirements in relation to consultation
requirements for legislative instruments. Unless a legislative instrument is,
for instance, of a 'minor or machinery nature' that 'does not substantially
alter existing arrangements' or is required as a 'matter of urgency' (section
18 of the LI Act refers), a rule-maker must not make a legislative instrument
before being satisfied that any consultation that is considered by the
rule-maker to be appropriate and reasonably practical to undertake has been
undertaken (section 17 of the LIAct refers).
In addition, depending on the nature of any products proposed
to be excluded, a Regulation Impact Statement (RIS) may also be required to be
completed prior to the making of instruments under the new power as part of the
Department's compliance with best practice regulation requirements.
There was broad support for the proposed amendments to the definition of
therapeutic goods to cover those products 'which do not meet a conventional and
accepted term of definition of “therapeutic products”':
ADIA concurs ...that such products are unlikely to fall within
the definition of therapeutic product and thus the protections afforded to
consumers within the Competition and Consumer Act (Cth) 2010, specifically
the Australian Consumer Law (ACL), are more appropriate. ADIA also concurs with
the Australian Government’s view that it is important 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.
Mr Kentwell and the CMC have however identified an issue that requires
further consideration. Given the scope of the proposed regulation-making power,
the committee considered some of the options for defining it, or guiding its
One option would be to define 'therapeutic goods' more narrowly in the
first place. As the minister pointed out in the second reading speech, the need
for reform has arisen because health claims are now being made for a wide
variety of goods, bringing them within the Act's current definition, even
though it was never meant to regulate such claims. However the Act deliberately
casts a wide net. Changing its scope would be difficult, requiring extensive
and careful consultation, and could risk undermining the core objective of
providing for 'the establishment and maintenance of a national system of
controls relating to the quality, safety, efficacy and timely availability of
Rather than limiting the definition of therapeutic goods in general, it
might be possible to define specific categories of goods that are exempted from
the Act. This is the approach taken in existing paragraph (e) of the definition
of therapeutic goods, which exempts from the Act products that instead fall within
the regulatory scope of the Food Standards Australia New Zealand Act 1991.
While this approach is feasible in the case of well-defined subjects of alternative
regulatory regimes, the goods at which proposed section 7AA is likely to be
aimed are those that would more appropriately be regulated by consumer law.
They are goods – such as mattresses or jewellery – where there is no relevant
regulatory regime to which the Act could refer. It would also be impractical to
try and predict what goods might in future have health claims made for their
use. Finding a way to define these goods would be difficult, if not impossible.
A third option would be to use the existing, more limited power
currently available to the minister under section 18 of the Act. That section
allows the Minister to remove goods from the operation of Part 3.2 of the Act
by regulation. The committee sought TGA advice on why this power was not
sufficient for the purpose. The department responded, pointing out that a good
that was exempted by regulation under section 18:
will still be subject to other requirements in the Act that
apply to therapeutic goods of that kind (ie those that would otherwise need to
be listed or registered). This would include, for instance:
The requirements in Part 3-3 of the TG Act for the goods if
manufactured in Australia to be manufactured by a licenced manufacturer in
compliance with Good Manufacturing Principles
Compliance with any standards made under section 10 of the
Act that would apply to the goods, and
Compliance with the advertising provisions in Part 5-1 of the
Act and the provisions in Part 5-2 and 5-3 of the Act about counterfeit
therapeutic goods and product tampering.
While it is possible to exempt therapeutic goods from the
operation of Part 3-3 by regulation (see section 34 of the TG Act) and for a
sponsor to seek an exemption from various standards that would otherwise apply
under section 10 of the TG Act (and possibly all standards), it is not
possible to exempt therapeutic goods from the advertising, counterfeit and
product tampering standards.
There are at least two further possibilities, although the committee
received no evidence from stakeholders about them. One would be to identify
categories of goods to which regulations under section 7AA could not be
applied. The Therapeutic Goods Act for example currently contains definitions
of medicines (section 3(1)) and biologicals (section 32A). The scope of
proposed 7AA could be limited by preventing the minister from determining that specific
classes of goods, such as medicines or biological, are not therapeutic goods, if
there is no intention that any such goods ever be exempted from the Act as a
Another approach could be to provide guidance around the exercise of the
regulation-making power. This is already done to some degree. The Act contains
an objects clause that provides guidance to the minister as to the purpose of the
Act's application. Section 17 of the Legislative Instruments Act requires
appropriate consultation to take place. In addition, during the course of this
inquiry, the department provided some guidance, quoted above, about situations
in which the power may be called upon, and constraints that the government
anticipates would apply to its exercise. In the event of a case coming before
the courts regarding the scope of the minister's power under proposed 7AA, the
department's submissions to this committee could provide guidance, though only
if the court considered there to be ambiguity in the legislation itself.
The committee thus notes there is a range of ways to further define the
exercise of delegated legislative power, but also that there are reasons why
several of these options may not be suitable in this case. The committee did
not receive sufficient evidence to consider the matter in more detail, but
notes that the Selection of Bills Committee has also drawn attention to the
issue of the scope of proposed section 7AA.
The Community Affairs committee notes that, should the Scrutiny of Bills
committee still have concerns after receiving a response from the minister, it
will draw these to the Senate's attention. At the very least, if there are no
appropriate options to more tightly define the powers of the minister, the
government could more fully explain why some parameters cannot be set around
The committee recommends that the Senate consider any findings or
recommendations made by the Scrutiny of Bills committee in respect of proposed
Non-therapeutic goods may appear in the Register for the following
- low risk products which are registered electronically can be
included in the Register without TGA scrutiny if the applicant/sponsor
certifies as to a range of matters. This can result in a product being placed
on the Register which is later found to not satisfy the definition of a
- products that were therapeutic goods when included in the
Register may cease to come within the definition because therapeutic claims are
no longer made.
- products that were therapeutic goods when included in the
Register may cease to come within the definition because they may (in the
future) come within a legislative instrument made by the Minister under
proposed section 7AA.
Currently goods determined to be non-therapeutic cannot be removed or
cancelled from the Register. Section 7 of the Act as it now stands does not
have any provision for such a power and 'current cancellation powers under the
Act only apply to ‘therapeutic goods’ and so cannot be used to remove goods in
the Register that are not, or have ceased to be, therapeutic goods.'
Proposed section 9F of the Act
contains a new power which would allow the Secretary to remove goods from the
Register that do not fall within the definition of 'therapeutic goods' under the
Act (i.e. non-therapeutic goods).
The effect of removing such products from the Act would mean that these goods
would not be subject to any 'regulatory burden' imposed under the Act.
In contrast if the product was cancelled it would still be subject to
regulation under the Act and it would become unlawful to import, manufacture,
supply or advertise the goods.
Under this proposed power the Secretary could only remove the goods from
the Register after giving the affected person notice of a proposal to remove a
good and give them the opportunity to make submissions in relation to the
proposal. The Secretary must take account of the submissions in their decision
and any decision to remove a good would be subject to internal review and
review by the Administrative Appeals Tribunal.
Medicines Australia were supportive of the amendments generally,
including of this provision, however they emphasised:
that sponsors must be informed, and have an opportunity to
respond, before a product is removed from the register under the proposed s
9F(3) of the Act.
Other submitters also expressed their support for the Secretary's new
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 TGA...The amendment 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.
This amendment is supported by ADIA.
There is currently limited capacity to remove products from
the Register...the provision of this additional capacity to the Secretary is a
valuable addition in maintaining the quality of the Register. This can only
strengthen the reassurance that the application of the Act can provide.
Mr Kentwell, however, expressed some concerns in relation to the new
power, largely in relation to its necessity:
The procedures for removal generally mirror the existing
procedures at subsection 30(3) and (4), "Cancellation of registration or
The department's response to Mr Kentwell's concern drew attention to the
difference between the 'removal' of a good and the 'cancellation' of a good
from the Register:
The power to remove products from the Register is quite
separate from the existing powers under the Act to cancel goods from the
Register about which there are safety, quality or efficacy issues. Such goods
do not stop being therapeutic goods and remain regulated under the Act as
As the Act now stands sections 25, 26 and 26A make reference to factors
that the Secretary must take into account when evaluating an application to
register therapeutic goods in the Register. Included is a requirement for the
Secretary to make an assessment of whether a good is conforming to an
applicable standard and whether it is compliant with any other requirements
related to advertising as found under Part 5-1 of the Act or Regulations.
The level of compliance with these advertising standards and requirements are
also factors which the Secretary must consider in determining whether to
suspend or cancel a good or when requiring information or documents to be
provided in relation to a good.
Although the Therapeutic Goods Advertising Code (the Code) is referred
to in Part 5-1 of the Act, the requirement for advertising of a good to comply
with the Code is not stated specifically in section 25. To ensure that there is
no doubt about the relevance of the Code under the proposed legislation
amendments would be made to Section 25(1) which would 'clarify that a reference
to advertising requirements includes a reference to the Code.'
Both Mr Kentwell and the CHC expressed concern that these amendments
would effectively be a 'broadening'
of the power of the Secretary to cancel products. They were also concerned that
the specification of the Code in this section would introduce 'doubt and
uncertainty' due to the fact that 'elements of the code can be subject to very
The department in response stated that
The amendments in Schedule 1 in the Bill do not make any
changes to the Therapeutic Goods Advertising Code (the Code) and are not
The effect of the amendments contained in Schedule I of the Bill
is to make absolutely clear that the reference to "any requirements
relating to advertising applicable under Part 5-1 (of the TG Act) or under the
regulations" where it appears in the TG Act for these purposes includes a
reference to the Code.
The proposed changes in Schedule I of the Bill therefore do
not add to the current powers relating to advertising, but serve to put beyond
doubt the existing requirements in relation to advertising requirements
including the Code.
It is noted that as part of the ongoing reform process as articulated in
TGA reforms: A blueprint for TGA's future (the Blueprint) the TGA is
undertaking consultation with stakeholders on the recommendations for advertising
reform outlined in the Advertising Regulatory Framework – Options for Reform
report and will provide advice to Government on the outcomes of this
Provision of information to the Secretary
The Secretary under the Act has a range of information-gathering powers
used to assist in making relevant regulatory decisions such as:
- whether to include a product in the Register;
- whether to cancel or suspend a product from the Register; or
- whether to place conditions on a product in order to ensure
compliance with regulatory requirements and standards. 
Failure to provide information
In the current legislation the Secretary has the power to cancel listed or
registered goods from the Register where a sponsor has failed to provide
information requested by the Secretary about these goods.
However as the Act now stands this power, under section 30, has been restricted
to requests for information about complementary medicines (those medicines
listed under section 26A).
Under the proposed legislation, section 30(2) of the Act would be
amended so that the Secretary would be able to apply this power to 'all
instances where a section 31 request for information is made (in relation to,
for example, other classes of medicines and therapeutic devices) and the
sponsor fails to provide the required information within the timeframe set by
This power would be 'in line with the Secretary's existing powers in relation
to requests made to sponsors for information about biologicals and medical
devices where the sponsor has not complied.'
Mr Kentwell expressed concern that the existing and proposed time-frames
in relation to the provision of requested information were not 'liberal' enough
and would be difficult for multi-national drug companies to comply with.
The department in their response articulated that the Secretary has
discretion in nominating timeframes that relate to requests for information, as
well as discretion in deciding whether or not to cancel a good from the
Register. The department also made reference to the Secretary's obligations
under the cancellation power and the fact that there are review processes
...the exercise of the proposed power to cancel is predicated
on the Secretary giving the sponsor notice of a proposal to cancel and the
opportunity to make submissions in response (see subsection 30(3) of the TG
Act) which the Secretary must take into account before making any final
decision (see subsection 30(4) of the TG Act). Any cancellation decision is
subject to internal review and review by the Administrative Appeals Tribunal
(see section 60 of the TG Act).
Providing information in relation
to certifications associated with listed products
Under the current legislation
'listed medicines are included on the Register via a low-cost
and streamlined electronic application and validation process (ELF). At the
time of listing it is the sponsor's responsibility to certify that its product
complies with the requirements of the TG Act. If the sponsor certifies this on
ELF, and the application fee has been paid, the medicine will be included on
the Register.' 
These certifications include:
- that the product is eligible for listing i. e. it only includes
certain ingredients the quality and safety of which have been considered by the
- that only low level claims are made in relation to the medicine;
- that the presentation of the medicine is not unacceptable;
- that the medicine complies with applicable standards and
advertising requirements; and
- that the sponsor holds evidence to support the claims made in
relation to the product.
Currently the Secretary only has the power to request information and
documents in relation to one of these certifications i.e. 'that the sponsor
holds evidence to support the claims made in relation to the product'.
Under the proposed legislation the Secretary would have this power
broadened in order to be able:
'...to request information and documents from the sponsors of
listed medicines about any of the certifications made by the sponsor at the
time of the listing of a medicine in the Register...'
and come to a view about whether the product complies with the
CHC were concerned that the proposed amendment was in fact a new power
to delist a product from the register if certifications were incorrect.
In their response the department sought to alleviate these concerns
The Secretary already has a power under paragraph 30(2)(ba)
of the TG Act to suspend/cancel goods from the Register if it appears to her
that certifications made at the time the goods were included in the Register
Under the current legislation section 23 sets out the procedures and
requirements that must be complied with when applying for the registration or
listing of therapeutic goods in the Register. In order for an application to be
all the required kinds of information must be provided;
- all the information must be provided in the appropriate form;
- the application fee must have been paid; and
- if applicable the product information and any samples must be
A 'non-effective' application would result if one or more of
the above elements was not provided as part of the application.
Depending on the type of product, 'different kinds and amounts of
may be required as part of the application process, in order for the Secretary
to assess the application and make an appropriate determination. If this
information is not provided with the application, the application itself is
taken not to be 'effective' and cannot be evaluated.
Currently the requirements are that such information needs to be
provided 'in a form approved, in writing, by the Secretary, as will allow the
determination of the application'.
Similar requirements exist in section 9D in relation to apply for variations to
entries in the Register.
The proposed amendments to sections 9D and 23 would specify that the
kind of information required by the Secretary would be that 'of the kind specified
in a legislative instrument made by the Secretary for the purposes of this
The requirement to have this information in an approved form would remain.
Mr Kentwell articulated his suspicions in relation to this proposed
amendment, noting industry 'dissatisfaction' with the application process for
registration of a prescription medicine and their perception that it:
...amounts to a mini evaluation with the object of rejecting
up-front any applications that may ultimately be rejected after a full
evaluation and thus attract appeal rights under section 60....It may well be that
this proposed amendment has been prompted by TGA fear that a legal challenge
may be forthcoming and that bolstering the legislation in this manner may afford
the regulator additional protection.
Mr Kentwell went on to recommend that:
Appropriate amendments be made to section 23 and 60 to ensure
that a right of appeal under section 60 is available where an application under
section 23 is deemed to be "not effective."'
It is important to note however that section 23 relates to the
'effectiveness' of an application and does not relate to the 'evaluation' of
goods which are the subject of an application. Sections 25, 26, and 26A would
apply in this instance.
It is also of note that under section 23 of the Act the Secretary does
not make the decision in relation to an application's effectiveness and as such
there is no provision for review under section 60. Existing processes under the
Administrative Decisions (Judicial Review) Act 1977 would apply if a
review process was sought in relation to a non-effective application.
The department further indicated in their response to Mr Kentwell's
concerns that the proposed amendments do not apply to 'issues dealing with applications
not being "effective"' 
and are only intended to:
'clarify the circumstances in which (and how) the Secretary
approves the kind of information that must be provided for an application to be
effective under those sections of the TG Act.'
The committee is of the view that it is important that any regulatory
decisions made by the Secretary are fully informed by accurate information and
is satisfied that the amendments are an essential step in ensuring that
therapeutic goods are dealt with in a way that best serves to protect public
health and safety.
Right to merits review
Under the current legislation the Act provides for a right to merits
review of decisions relating to the approval of Product Information (PI) – 'a
document that must be provided with particular kinds of medicines – mainly prescription
and "pharmacist only" medicines.'
PI documents are required to undergo assessment by the TGA as part of the
approval process for the medicine and should contain information such as:
...the indication/s (i. e. what the medicine is to be used
for), dosage and administration, composition, the medicine's contraindications
(i. e. when the medicine must not be used) and any particular information and
precautions concerning its use including its interactions with other medicines
and adverse effects. It also contains information about the pharmacology and
pharmacological actions of the medicine, clinical trials related to the
indications, symptoms, signs and recommended treatment of overdose or accidental
poisoning, presentation (dosage form, quantity, proportion or strength of each
therapeutically active ingredient, container type, pack size etc) and storage
conditions, the name and address of the sponsor and the relevant schedule of
the Poisons Standard of the substance in the medicine.
Although the proposed legislation would clarify that the approval by the
Secretary of PI for a medicine is a separate decision to the Secretary's
decision approving a medicine's registration or variation, the PI is evaluated
at the same time and as part of the evaluation of the application for
registration or variation of the medicine.
The content of the product information is a critical element
of the process by which the Secretary forms her view that the medicine can be
registered on the basis that it satisfies the relevant statutory criteria or,
as proposed to be varied, can continue to be registered.
Under the proposed legislation section 60 of the Act would be amended
to remove the right to a specific merits review process for decisions made in
relation to PI. The merits review process would still remain available for
decisions made by the Secretary in relation to a medicine's registration or
The department justified the proposed removal of the PI merits review
process stating that was necessary in these instances:
...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 medicine's
entry in the Register.
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) any concerns with the PI can effectively be
addressed through a review of the registration or variation decision.
They also stated:
There is also a concern that if the approval of product
information were to be the subject of a separate right to merits review, a
situation could arise whereby product information is altered through the merits
review process and, as a result, contains information that is inconsistent with
the basis upon which the goods were considered by the delegate of the Secretary
to be suitable for registration including, in particular, in relation to its
safety, quality and efficacy and/or does not accurately describe the basis on
which the delegate came to the view that it could be safely prescribed or used
for the purposes approved by the delegate.
In such circumstances, there would not appear to be a
mechanism to amend or revisit the decision as to the registration of the
medicine. Such an outcome could be confusing for prescribers, and could
potentially pose a threat to the health of patients.
The removal of the PI merits review process and the department's
justification, as articulated in the explanatory memorandum,
was of concern to Mr Kentwell:
I do not accept the rationale advanced to justify the
exclusion of merits review of a decision under 25AA approving the Product
would appear to be a retrograde step in the context of open and transparent
The committee understands the argument put by the department. It is
important that anyone wishing to have a decision in this area reviewed has
clearly explained to them that they have access to merits review that extends
to the substance of matters included in PI, even if the PI decision itself is
The Parliamentary Joint Committee on Human Rights has also raised
similar concerns in relation to the proposed amendments to section 60 (see
Chapter 1). They will be seeking clarification of this issue from the
Parliamentary Secretary for Health and Ageing and reporting on the response in
due course. This committee notes that, should the Parliamentary Joint Committee
on Human Rights still have concerns, it will draw these to the Senate's
The committee recommends that the Senate consider any findings or
recommendations made by the Parliamentary Joint Committee on Human Rights in
respect of amendment of section 60.
Publication of regulatory decisions
Under the current legislation the Secretary must publish certain
regulatory decisions made under the Act in the Australian Government Gazette.
Under the proposed legislation the Secretary will have the option to
publish these regulatory decisions in either the Australian Government Gazette
or the TGA website, or in both, if that is considered appropriate.
ADIA was not supportive of the amendment particularly as they understood
from the explanatory memorandum that the website was to be considered
preferable to the Gazette.
Although ADIA is supportive of the TGA publishing its
decisions on its website, ADIA believes that in the interest of transparency
and good regulatory process, such decisions should also be featured in the
Australian Government Gazette.
In response the department stated:
Publication on the TGA's website (noting that the TGA is a
division of the Department of Health and Ageing) ensures maximum accessibility
for consumers, industry health care professionals and the public to the
information. There is also a cost to the TGA for publishing decisions in the
Gazette (paid for by industry as the TGA operates on a 100% cost recovery
basis). Publication on the TGA's website is designed to provide the public with
an easier, and more familiar, way of accessing information about regulatory
decisions than through the Gazette. There is nothing to prevent the decisions
being published in both, if that is considered appropriate.
Although the proposed amendments would provide the Secretary with the
publication options for 'almost all provisions in the Act that currently
require, or authorise the Secretary to publish information or the particulars
of regulatory decisions'
it was noted that the option did not extend to the Secretary's new powers under
proposed Section 9F with respect to a 'notice of removal'. The proposed
legislation would require that the publication of such a notice would be on the
TGA website only.
Mr Kentwell whilst supporting the publication of the 'notice of removal'
...include the requirement that where the Secretary's decision is
overturned on appeal that an appropriate notice setting out the particulars of
the outcome of the appeal and reinstatement of the good of the Register is also
published on the Department's website.
He also felt that there should be a similar requirement in
circumstances where the Secretary's decision to cancel a therapeutic good was
In response to Mr Kentwell's proposal the department acknowledged:
...that there is no obligation on the Secretary to ensure that
particulars of the overturning of a decision to remove the product from the
Register (for instance on internal review or by the Administrative Appeals
Tribunal) is also published, the Department notes that there is no current
obligation on the Secretary under the TG Act to publish in the Gazette outcomes
of such reviews where the Secretary is obliged to publish particulars of the
original decision in the Gazette.
The department also indicated that this was also the case for
particulars of the overturning of a decision in relation to the cancellation of
a good from the Register. However they indicate that:
...as part of the Blueprint reforms currently being
implemented, the TGA is considering the wider publication of information about
its regulatory decisions which would include providing information about the
outcome of reviews of such decisions.
The committee notes two issues, one specific, and one of broader
The committee is unsure why the proposed 'notice of removal' power would
be the only one for which gazettal is not an option (in contrast to others
where there is a choice between Gazette and website).
The committee recommends that the bill be amended to align the
publication options between proposed section 9F and other existing provisions
in the Act.
The committee seeks clarification of a broader issue about the
permanence of records, relevant to these provisions in the Act and in other
government legislation. The committee supports web-based publication of
information as a means that has the advantage of timeliness and widespread,
However, websites do not create a permanent record in the way that the
Gazette does. It is not clear how superseded orders or regulatory actions, for
example, might be found if they are removed from the website. In contrast,
previous government gazettes can always be examined.
The committee seeks an undertaking from the government that there will
be an equally permanent (and public) record of decisions published on the TGA's
website as there is for those published in the Gazette.
Consultation on the Bill
There was concern expressed in relation to the lack of consultation with
industry and consumer stakeholders prior to the release of the Bill. ADIA was particularly
concerned that 'the first opportunity that industry had to discuss the proposed
legislative amendments was on 26 March 2013... some six days after the Bills were
presented to parliament' and indicated that the Bill:
...constitutes a response to several major reviews of
therapeutic goods regulation that were undertaken in 2010 and 2011 and
addresses matters from product regulatory standards, advertising, promotion and
transparency. It would have been possible, and indeed desirable, to deal with the
proposals before the parliament as part of, rather than separate from, that
series of reforms. ADIA is confident that if this had been the case, proper
industry consultation could have been undertaken.
Medicines Australia also suggested that more consultation would have
been welcome and urges that this be a future consideration:
Industry has consistently supported a transparent and
consultative approach to regulatory reform. Industry welcomes advance
notification or consultation prior to introduction of future legislation into
In their response the department noted that:
Consultation was not undertaken in relation to the Bill, as
the amendments in it are principally designed to clarify the operation of a
number of existing provisions in the TG Act, or ensure that various
requirements in the TG Act are more consistent, and better aligned across the
different types of therapeutic goods, rather than introducing new policy
measures or implementing any of the reforms the Government is currently considering
in relation to therapeutic goods.
There is extensive stakeholder and public consultation being
undertaken in relation to the current reform proposals on medical devices and
complementary medicines. There will also be consultation undertaken in relation
to proposals relating to advertising reforms.
The committee is supportive of the bill and the improvements it is
designed to achieve. The complexity of some of the provisions, and the
confusion they have elicited amongst (often experienced) stakeholders, indicate
the importance of appropriate consultation on bills prior to the introduction
to parliament, where at all possible, particularly in those cases where
legislative timelines are comparatively tight.
The committee has noted its concerns in respect of proposed section 7AA
and amendments to section 60, and refers the Senate to any findings or
recommendations of the Scrutiny of Bills and Human Rights committees.
Subject to the preceding recommendations, the committee recommends that
the bill be passed.
Senator Claire Moore
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