This chapter focuses on key issues raised in relation to particular provisions
of the TGA Bill. The committee did not receive evidence outlining concerns
about the proposed changes in Schedules 4, 5, 8 and 9 of the TGA Bill, while very
little evidence addressed the TGCA Bill, and so these are not discussed here.
The concerns that submitters raised included:
The nature and extent of consultation on the TGA Bill;
The importance of public education and safety surrounding the
proposed provisional approval pathway for promising new medicines;
The development of the list of permitted indications and evidence
required to support complementary and traditional medicines listed under a
Medicines that had passed the proposed new assessment pathway
being able to indicate this in promotional material;
The Therapeutic Good Administration (TGA) taking sole
responsibility for the proposed new complaint system;
Abandonment of the pre-approval system for advertisements; and
Increased and harsher penalties for industry occurring in tandem
with the abolishment of the pre-approval system that had ensured their
Consultation on the provisions of the TGA Bill
Several submitters stated their concern about the nature and extent of
consultation that had been carried out on the TGA Bill prior to it being
introduced into Parliament.
PharmaCare Laboratories submitted that industry had been consulted on
each phase of the reform 'separately and in stages, meaning that it is
difficult for the industry to clearly understand the full impact of the
regulatory reform in totality'. They contended that consultation had not yet
occurred on some elements at the time the draft bills were provided for
consultation, despite these being 'directly relevant' to the provisions of the
They further asserted that stakeholders were given only two and a half business
days to give feedback on the exposure draft of the two bills, despite the TGA
Bill being 200 pages long and its explanatory memorandum being 152 pages. They
argued that the period of time given for feedback was inconsistent with the
Guidance Note on Best Practice Consultation released by the Department of Prime
Minister and Cabinet's Office of Best Practice Regulation, which recommends a
consultation period of between 30 to 60 days.
However, other submitters were of the opinion that the TGA Bill was
backed by 'a rigorous and inclusive review and consultation process'.
Medicines Australia emphasised that 'significant public consultation' had
occurred on the issue of provisional registration since the MMDR Review:
The TGA has conducted numerous consultations and workshops;
with respect to the provisional approval reforms, these consultations have
occurred over more than 12 months. We are confident that the TGA will continue
to consult with relevant stakeholders, including Medicines Australia and its
members, on implementation aspects of provisional approval, once the reforms
are enacted by Parliament.
The Department of Health (the department) noted that the MMDR Review
involved a broad range of consultations with consumers, health professionals
and industry stakeholders, and that the Australian Government had chosen to
conduct further stakeholder consultation on some of the MMDR Review's
recommendations before implementing them.
The department outlined in its submission that it had carried out a range of
consultations on the government's response to the MMDR Review and on specific
schedules of the TGA Bill.
Schedule 1: Provisional approval pathway
Much of the evidence provided to this committee expressed support for
the establishment of a provisional approval pathway for promising new medicines.
For example, GlaxoSmithKline wrote that '[t]his important measure will ensure earlier
access for patients to innovative medicines without compromising standards of
quality, safety or efficacy'.
However, the Royal Australasian College of Physicians expressed its
concern about the provisional pathway and emphasised that 'maintaining patient
and public safety in the use of therapeutic goods must be of paramount
The Consumers Health Forum of Australia suggested that consumers might
not understand the status of provisionally registered medicines. They proposed
that there should be 'a well-constructed patient information/education package
that explains what a provisional registration means so that consumers
understand that the medicines have not been through the full TGA assessment
The department outlined the measures that it intended to take to ensure
that there would be sufficient protections in place for patients, and patients
would be aware that a medicine was provisionally approved:
The Bill provides that provisionally registered medicines
are, for the most part, to be treated the same as fully registered medicines
under the Act. This is intended to enable all of the requirements and
safeguards which currently apply to fully registered medicines to also apply to
provisionally registered medicines. The main difference is that provisional
registration is time-limited and there will be additional post-market
monitoring processes. For example, the product information of all provisionally
approved medicines will carry a prominent black triangle with accompanying wording,
to alert health professionals and patients to the fact that the medicine is
newly (and provisionally) approved and that any adverse events should be
reported to TGA to allow for prompt assessment.
The department also stated that the anticipated benefits of the medicine
must outweigh its potential risks, and that the sponsor must report '[a]ny new
information that changes the benefit-risk profile of the medicine' to the TGA.
The Secretary, under the proposed amendments, would be able to vary the Register
entry of provisionally registered medicines if new information called into
question its quality, safety or efficacy. The department further explained that
the provision would allow:
...the Secretary to reduce the class of persons for whom the
medicine is suitable, change the directions for use of the medicine, or add a
warning or precaution in relation to the medicine.
Schedule 2: List of permitted indications
Some submitters raised questions about the proposed list of permitted
indications provided for under Schedule 2.
One line of argument against the list was that there had been a lack of
consultation concerning Item 5 of Schedule 2, in which the Minister may
specify, by legislative instrument, evidence requirements for medicines, and
applicants would be required to certify that they held evidence meeting the
requirements of the legislative instrument.
Vitaco Health (NZ) Limited argued that '[a] legislative instrument for evidence
was not recommended by the MMDR Panel. There has not been consultation or a
Regulatory Impact Assessment, therefore it should not be included'.
Another submitter stated his concern that while the legislative
instrument proposed in Item 5 would require the sponsor to hold evidence of
claims for a product, the proposed changes did not 'specify that this evidence
must be supplied to the TGA'.
A number of submitters who had viewed the TGA's proposed permitted
indication list contended that many of the permitted indications appeared to
lack scientific evidence to back them.
Several academics argued that '[t]he national pharmaceuticals and
medical devices regulator should not be providing legitimacy to products that
are inherently non-efficacious'.
The basis of their argument was that over the past three decades, successive studies
and inquiries by regulatory bodies and parliamentary committees had been unable
to 'substantiate claims by adherents of homeopathy that those products are
therapeutically efficacious', including the department's review of private
health insurance for natural therapies, and a study by the National Health and
Medical Research Council.
The Royal Australian College of Physicians were of the opinion that the
inclusion of indications on the list as medicines backed by tradition would
encourage industry to avoid providing scientific proof of efficacy of its
products, as well as endorse 'pseudoscience and...mislead and confuse consumers'.
The College suggested that even if a particular product (product X) has no
benefit to health at all:
the proposed Bills will allow the manufacturer to claim that
X nourishes or rejuvenates, or assists weight reduction or jet lag.
Manufacturers can simply state that X is a traditional product that has at some
point been recommended by various alternative practitioners.
This justification is so vague that it is hard to see any
product failing to meet that low bar. It would be extraordinarily difficult to
refute the statement that some tradition has recommended product X for whatever
therapeutic benefit the manufacturer chooses to advertise.
To base the regulation process merely on manufacturer claims
about tradition entirely ignores the question ‘Does it work’?
Research Australia contended that '[t]here is a real risk that consumers
will infer that, because a complementary medicine refers to an indication that
is allowed by the TGA, the TGA is asserting the medicine is effective for this
They argued that the MMDR's expert panel had shared this concern and had proposed
Recommendation Forty Four of the MMDR Review to address it, requiring a sponsor
to include a disclaimer on all promotional materials 'to the effect that the
efficacy claims for the product have not been independently assessed and/or are
based on traditional use'.
A number of submitters expressed concern that anti-complementary
medicine activists had pushed to limit 'the number, strength and specificity of
These submitters and others called for sponsors not to be required to draw from
the permitted indications on the list but, rather, for the list to be retained
Many submissions called for the committee to request that the TGA
require all indications based on traditional evidence to include a disclaimer
stating that the product had no scientific evidence of efficacy.
Some proposed drawing on the disclaimer required by the United States Federal
Trade Commission accompanying over-the-counter homeopathic products, which
states that these have not been substantiated by scientific evidence and are
not accepted by most modern medical experts.
However, the committee also received evidence arguing against the
proposed disclaimer put forward in other submissions.
For example, the National Institute of Complementary Medicine stressed that in the
majority of cases, scientific evidence has been used to prove the efficacy of
traditional medicine, and argued that sponsors may choose 'to refer to
traditional usage as a positive statement of safety and effectiveness precisely
because of a product’s long history of safe and repeated use'.
Dr Jon Wardle, from the Australian Research Centre in Complementary and
Integrative Medicine, emphasised that traditional medicine terminology is
currently being standardised by the World Health Organisation (WHO) for
inclusion in the International Classification of Diseases. He noted that
Australia is an active partner in the International Standards Organization's
Traditional Chinese Medicine Technical Committee. He argued that by including
the type of disclaimer outlined above, Australia would not be in accordance
with recent international developments that were moving towards recognising the
value of traditional medicine:
...[A]s part of its Traditional Medicine Strategy...the
WHO has... recommended that all member states appropriately include traditional
medicine terms in their regulatory, legislative and policy initiatives around
traditional and complementary medicine products and practices.
Beyond this formal work, legitimate traditional evidence
claims (i.e. those that are verified as having come from a legitimate tradition
of use and being compliant with that tradition of use) have also been held up
in Australian and international law. These legal developments and the policy
work by WHO would make a negative advisory statement or restriction of use of
traditional medicine terms problematic, and most likely inconsistent with
national and international law and new global regulatory norms and
Dr Wardle further argued that standardising traditional indications in
regulatory and policy tools would provide the following benefits:
Incorporating traditional indications offered regulatory guidance
around how traditional claims could be used appropriately, and placed the
burden of proof on sponsors to show that their traditional claims are based on legitimate
and recognised traditional medicine systems;
Traditional indications could be used as outcomes in research
projects in a more effective and rigorous way, and their use would likely
bridge the current evidence gap between traditional and conventional diagnoses;
The use of traditional indications could lead to acknowledgement
and legal action against people co-opting or misrepresenting indigenous intellectual
Regulating traditional indications would also provide consumers
with assurances that the product they are buying is equivalent to the
traditional medicine with a documented history of traditional and safe use.
The Public Health Association of Australia submitted that while
regulators need to find ways to incorporate traditional medicines in line with
international developments, there needs to be further investigation into
whether the claims made about these products do indeed align with traditional
International developments, such as the development of a
traditional medicine chapter in the update of the International Classification
of Diseases, necessitate that regulators begin to identify ways in which to
ensure claims based on traditional knowledge do in fact have a legitimate basis
to make those claims. However, some of the claims in the proposed list would be
unlikely to be supported by established texts in those traditions...In some
cases the product making traditional claims may not reflect the product that
was traditionally used...The PHAA [Public Health Association of Australia] suggests
that traditional indications should be reviewed to ensure that they do align
with the traditions from which they are purported to come, so that the use of
traditional indications is not used as a pathway to entrench inappropriate
In its submission, the department stated that it intended to require a
statement regarding traditional use:
The Government supported the intent of [Recommendation
Forty-Four of the MMDR Review], and it is proposed that a label statement
regarding traditional use will be required. However it will not require
sponsors to place a disclaimer on product labels that the products have been
The reasons the department gave for not mandating a disclaimer on
traditional medicines were:
The additional regulatory burden that this requirement would
The experience in the US indicating that these disclaimers are
ineffective in influencing consumers' beliefs about the efficacy or safety of
A number of independent studies published in major consumer
research and health policy journals that also concluded that such disclaimers
are ineffective; and
Face-to-face meetings between senior TGA and US Food and Drug
Administration (FDA) officials that confirmed this view, based on additional
in-house FDA research that the US disclaimer had little or no effect.
The department committed to the TGA conducting further consultation on
how consumers could be better educated about the list, including the difference
between listed complementary and registered medicines.
Support for the list of permitted
A number of submissions were supportive of the proposed list of
permitted indications, albeit with conditions.
The Public Health Association of Australia stated that 'in principle' it
supported the changes, but had concerns about the extent of the list, and
proposed that it 'be tightened significantly and focused on modest indications
(e.g. “may be helpful...”, “may assist...”, etc.)'.
The Australian Self-Medication Industry expressed support for the list,
though requested that:
The list not include claims, only indications;
The list be clearly worded, comprehensive and appropriate;
Processes for amending the list be reasonable and subject to
Products matched to particular indications not be considered in
terms of their efficacy, but rather their suitability.
The joint submission from the National Boards and the Australian Health
Practitioner Regulation Agency was unreserved in its support for the list,
suggesting that the current system would 'be greatly strengthened by the
removal of the free text field for indications and replaced by a more
controlled approach to permitted indications'.
The department argued that the TGA Bill would 'provide transparency on
what indications are suitable for listed medicines to help prevent
non-compliance', as well as 'greater protection for consumers from misleading
and inappropriate claims'. By introducing a permitted indications list and
removing the option of a free-text field for sponsors, it suggested, the TGA
would be able to better identify trends in non-compliance.
It further contended that the proposed list 'provides an additional
layer of control to limit listed medicines...provided appropriate evidence is
held by the medicine sponsor', including evidence of traditional use.
Sponsors would no longer be able to use the term 'may' in their labels (such as
'may relieve symptoms of...'), because:
it can imply that the sponsor does not have evidence of
sufficient quality to demonstrate that their medicine is effective. This is not
consistent with the legal requirement for sponsors to hold evidence for the
indications they make for their medicine.
In relation to the number and content of the permitted indications, the
department emphasised the level of consultation the TGA had undertaken in the
development of the list:
The TGA has...undertaken significant consultation to develop
the final proposed list of permitted indications and is satisfied that it is
commensurate with the low risk nature of listed products and appropriately
balances consumer and industry concerns. People will be able to apply to the
Secretary for a recommendation that the Minister add another permitted
indication to the list. The legislative instrument specifying the list of
permitted indications will be required to be tabled in Parliament and be
subject to disallowance.
The department clarified that it would introduce 'greater clarity about
the evidence base for listed complementary medicines' by requiring listed
medicine products to identify their evidence base in the Register and on the
medicine's label. This could include statements such as 'traditionally used in
Chinese medicine'. A new mandatory requirement would be introduced for these
products to include an advisory statement on their label, recommending that the
consumer seek the advice of a practitioner before using the medicine.
The department advised that it intended to make labelling requirements
stricter. It further stated that under the proposed amendments, the TGA would
have the power 'to immediately cancel a medicine from the Register',
particularly if the product's advertising and label suggested that the product
could 'be used to treat a serious form of a disease, condition or ailment'.
Schedule 3: New assessment pathway
The committee received evidence outlining some concern about the
proposed new assessment pathway, based on an assessment of the medicine's
claims and indications. The Australian Self-Medication Industry's main source
of concern was that successful sponsors would be able to indicate in
advertising that they had passed this assessment:
A claimer is likely to be taken as TGA endorsement for a
product (which would be in breach of the current Advertising Code). This TGA
endorsement will likely be interpreted by consumers as applying to the product,
its labelling and all the product advertising. Any advertising to consumers, no
matter how misleading, will therefore be likely to be taken to be accurate
since the product has the TGA’s endorsement...
For products that use the same label in other markets (e.g.
New Zealand) the claimer on the label may not be acceptable in the other
market. A significant proportion of ASMI members’ products are packaged in
harmonised Australian/New Zealand labelling (with individual member portfolios
ranging from about 50% harmonised to as high as 95% harmonised).
However, other submitters welcomed the proposed new pathway. The
National Boards and the Australian Health Practitioner Regulation Agency
suggested the new approach would provide an incentive for industry to move
towards independent assessment of product efficacy.
Vitaco Health (NZ) Limited echoed this assertion, writing that '[t]he new
"listed assessed" pathway will provide our business with the
opportunity to research, innovate and expand the range of therapeutic use'.
Complementary Medicines Australia anticipated that the new pathway and
the ability of sponsors to indicate that their product had passed the
assessment would lead to further investment into research by industry into
If implemented successfully, this represents a ground-breaking
and unique opportunity for complementary medicine products to gain recognition
for undergoing rigorous scientific assessment. By incentivising expansion of
the clinical research base for non-patentable naturally occurring substances,
it will encourage increased investment by industry into Australian research
bodies. Consumers, both locally and globally, would be able to access
complementary medicines for an increasing range of health benefits.
The department in its submission outlined a number of anticipated
advantages to the proposed new assessment pathway, such as:
Access for consumers to a broader range of evidence-based
products to self-manage their health;
Increased evidence for the effectiveness of products, which would
build confidence in the sector amongst consumers and health professionals; and
The provision of a regulatory framework and market advantage for
The department also noted that careful consideration and consultation
with stakeholders would be required before deciding on the design and use of
Schedule 6: Changes to advertising of therapeutic goods
Many submissions to this inquiry raised concerns about the proposed new
advertising framework put forward in Schedule 6 of the TGA Bill. The issues that
submitters discussed fell broadly into three categories:
The TGA taking sole responsibility for the complaint system;
Abandonment of the pre-approval system of advertisements; and
No mention of a self-regulatory regime.
TGA given sole responsibility for
A number of submitters stated that they were concerned about the TGA
being given sole responsibility for resolving complaints about advertising.
Professor Jon Jureidini stated that the source of his concern was the TGA's
'unenviable reputation of not providing an outcome on hundreds of complaints
sent to them'.
Associate Professor Ken Harvey and Professor John Braithwaite stated
that 'there are concerns about the current operation of the TGA which must be
addressed. The most important is a lack of transparency in dealing with
Submitters further highlighted that they were worried that the shift to
the TGA would lead to a loss of stakeholder involvement.
Associate Professor Bruce Baer Arnold and Associate Professor Wendy Bonython
argued that the TGA was viewed poorly outside industry because of its
reluctance to engage with stakeholders:
The TGA has been reluctant to meaningfully engage with
stakeholders outside industry, fostering perceptions that it has experienced
regulatory capture (ie incorrectly considers that the interests of the
businesses that it regulates are the same as the interests of the organisation
and of the community at large). It is regarded with disquiet by health
practitioners, academics and others over its failure to anticipate and/or
To overcome this perception, several submitters requested that the TGA
explain publicly how it intended to involve stakeholders in the new advertising
In its submission, the department outlined that the new system would
involve improved stakeholder input, and suggested that the costs involved in
running the current system would be used to enhance compliance and undertake
enforcement in the new system:
At present, as Prof Jureidini describes in his submission to
the Committee, transparency around the handling of certain advertising
complaints can be significantly constrained... The changes in the Bill will
correct this as the routine publication of notices and directions has been incorporated
into transparency provisions built into the Bill.
Improved consultation mechanisms will enhance stakeholder
input on the new system. While stakeholder involvement is currently provided by
the Complaints Resolution Panel (CRP) and the Therapeutic Goods Advertising
Code Council (TGACC), which are to be abolished, these committees have a number
of deficiencies and cost about $ 600,000 per annum to support – which could
alternatively be directed towards increased compliance and enforcement activities.
A group of submitters proposed that one way to overcome perceptions of a
lack of transparency on the part of the TGA would be to require the Secretary to
take action (instead of allowing the Secretary the option) in instances where
there had been advertising contraventions.
The department argued that changing this language 'would significantly
limit [the] TGA's ability to take proportional and appropriate responses to
regulatory non-compliance'. It further contended that flexibility in the
wording of the legislation was necessary, because in some instances, 'it may be
more appropriate to take other action...including education and guidance...'
Regarding the issue of transparency of complaint handling within the
TGA, the department stated that:
New section 42DY empowers the Secretary to issue written
public warning notices about therapeutic goods if the Secretary...is satisfied
that it is in the public interest to issue the notice. These provisions will
give the Secretary or her delegate the authority to publish and will also
require publication of complaint outcomes as soon as practicable where a breach
has been substantiated and where the person responsible for the advertisement
is required to take some action...
As well as routine publication of notices and directions,
other complaint outcomes will be published, including where compliance has been
achieved following TGA’s interaction with the advertiser.
Key performance indicators for the new system will be
published on a quarterly basis.
The Pharmacy Guild of Australia suggested 'there are significant
challenges' inherent in establishing the TGA as an effective single point for
handing and resolving advertising complaints, and recommended that 'the TGA
must be given adequate financial and workforce resources to investigate and
respond to complaints in a timely manner'.
Some submitters argued that the current system of resolving advertising
complaints should not be abolished at all.
Others emphasised the difficulties presented by the current system.
The Medical Technology Association of Australia stated that they welcomed 'the
implementation of a more transparent and efficient complaints management
process with [the] TGA as the sole point of contact and decision-making
Complementary Medicines Australia was of the opinion that the proposed
amendments would lead to 'an excessively cumbersome advertising system' being
replaced 'with a streamlined and centralised mechanism that includes tougher
sanctions, but reduces red-tape and improves fairness of complaint-handling'.
Abandonment of the pre-approval
system for advertisements
A number of submitters outlined concerns about the abandonment of the
TGA's current system of pre-approval of advertisements to move towards a post-market
These concerns were spread across a range of submissions, from consumer and
advocacy groups to industry.
Mr Allan Asher contended that it was predominantly industry and consumer
interest groups that were in favour of removing the current system of
pre-approvals which take, on average, seven days to be approved.
Similarly, the Public Health Association of Australia argued that the current
system of pre-approvals was working, and support for the shift came predominantly
from industry and the media.
CHOICE, among other submitters, stressed that the pre-approval process
provided important protections for consumers, and emphasised that most advertisements
in the current system were determined to be in breach of the Therapeutic Goods
The Pharmacy Guild of Australia suggested that the enhanced sanctions
and penalties and post-market monitoring proposed in the TGA Bill to offset the
risks of a post-market monitoring scheme would not be:
sufficient protection for consumers compared to the current
process. Advertising campaigns generally only run for a relatively short period
of time and misleading health messages can have a lasting impact on consumer
beliefs and behaviour. Investigations to determine whether an advertising
breach has taken place often take several months, by which time many
advertisements will have finished. It is far better if consumers are not misled
in the first place rather than trying to mitigate the effects of an
irresponsible advertisement after it has reached the public domain.
Research Australia was of the opinion that the success of the proposed
system 'remains to be seen' and would 'depend on how quickly and effectively
the TGA responds to complaints about advertising'. It questioned whether the
TGA would be adequately resourced to implement the complaints process.
NewsMediaWorks, a peak organisation representing Australia's major news
Unless there is ongoing and consistent market review, a framework
for complaints handling and sanctions in place prior to the dismantling of the
pre-approval system there is significant potential for increases in the number
of advertisements which breach the Code resulting in consumer detriment.
However, several submitters welcomed the proposed shift to post-market
surveillance. For example, the Pharmaceutical Society of Australia argued that
abolishment of the vetting and pre-approval of therapeutic goods 'was felt to
be a logical option given the [MMDR] Review outlined that complexities and
inconsistencies existed in the pre-approval arrangements'.
Similarly, Accord Australasia emphasised that the provisions in the TGA
Bill for harsher penalties would offset any negative impacts on consumers
brought about by abolishing the pre-approval system:
Accord does not hold the same reservations as other
submitters have expressed, in that we do not believe that the removal of
pre-approval for certain therapeutic goods advertisements will necessarily
result in consumer detriment. It is important to note that the Bill introduces
a number of additional changes which will strengthen rather than diminish
consumer protection and enhance consumer access to information.
A number of submissions called for a transition period to adapt to the
proposed post-market surveillance system, for varying reasons. Some asked for a
transition period until a government-proposed formal three-year review of the
reform package has been completed;
while several industry bodies asked for a transition period that would allow
industry to adjust to the absence of a pre-approval system, particularly in
light of the proposed stricter penalties and the number of breaches noted to
have occurred via the vetting system.
The department in its submission outlined the measures that it had
undertaken to date to ensure that post-market surveillance would be effective:
Changes to enable more comprehensive post-market monitoring
of therapeutic goods have...been introduced. These include implementation of new
and enhanced analytics capabilities and a new adverse events reporting system;
the launch of the Pharmacovigilance Inspection Program in September 2017; and
work with sponsors to reformat Product Information documents to ensure
important prescribing information is easily accessible. Further reviews into
the medicines scheduling process and the appropriate regulation of low-risk
therapeutic goods have been carried out.
It also clarified that it would implement measures to ensure that the
shift to the new system would be smooth, including by providing detailed
guidance for advertisers to understand the new penalties regime:
[T]he introduction of a broader range of sanctions and
penalties would commence on the day after the Bill receives Royal Assent, and
an industry education program will commence in the second quarter of 2018 to
ensure that these measures are in place before the pre-approval system is
removed. Subject to the passage of the Bill there will also be detailed
guidance material available on the TGA website to assist advertisers with their
understanding of the new advertising sanctions and penalties regime.
In response to concerns that the TGA would not react quickly enough to
non-compliant advertisements, the department emphasised that the new regulatory
system proposed under the TGA Bill would 'allow the TGA to take speedy
enforcement action in response to serious non-compliant advertising, such as
seeking a Court injunction to prevent an advertisement being aired'.
The department acknowledged that under the current system, most
pre-approved advertisements are found to need changes so that they are
compliant. However, it contended that the system encourages advertisers to use
'the mandatory pre-approval system as a form of editing consultancy for the
content of their advertisements', and so is not an accurate representation of
how many advertisements would not be compliant under the new, stricter system
requiring industry to ensure its own compliance.
The department acknowledged that although most stakeholders from the
MMDR Review agreed that the current advertising system was ineffective, there
were divergent views about what a new system should look like. It outlined that
it would implement a review of the proposed complaint handling system after
Following a public consultation process, the Government has
decided that the TGA will assume responsibility for handling all complaints
about therapeutic goods advertisements directed to the public from 1 July 2018,
and that this model will be independently reviewed after three years of
operation to determine whether it is the most effective solution.
In relation to the call for a transition period, the department argued
that delaying the removal of the pre-approval system until the three year
review would be problematic for several reasons:
It would require amendments to the Bill and its reconsideration
in the House, thereby delaying other important measures in the Bill;
Delaying the removal of the current pre-approval system would be
unlikely to provide useful data on which to judge the new advertising system,
because the new advertising system would not be in place during that period;
There would also be greater costs as elements of both the new and
former advertising regulatory systems would be in place, with the cost of the
current pre-approvals system being about $1.4–1.5m annually; and
Delaying the abolition of pre-approval would severely limit the
actions that the TGA could take against advertisements found to be non-compliant.
No mention of a self-regulatory
The Australian Self-Medication Industry (ASMI) drew attention to the
fact that while the proposed amendments in Schedule 6 addressed the first part
of Recommendation Fifty Five of the MMDR Review, the Bill 'provides no
incentive or guidance' on the second part of the recommendation, regarding a
ASMI further argued that the removal of the pre-approval system for
'product sponsors to have marketing claims pre-approved for compliance' would
cause problems for industry because of the introduction of 'much harsher
criminal and civil penalties'.
They outlined that because of this situation, they intend to offer from 1 July
2018 a 'voluntary, self-regulatory, advisory service' for industry to 'reduce
the likelihood of breaches and the potentially (new) severe penalties and
sanctions'. The intended effect of this service would be a reduction in the
level of non-compliance, thereby 'reducing the resource impact on the TGA', and
would mean that 'those advertisements not subject to self-regulation will be
easily identifiable by the TGA'.
ASMI proposed that a due diligence provision be included in the TGA Bill
specifically identify an advertiser’s use of a
self-regulatory service as a factor to be considered when assessing whether
that person took reasonable steps to ensure compliance and when assessing what
penalty (if any) should be applied.
Schedules 6 and 7: Penalties and sanctions
Some concerns were raised in evidence regarding the proposed amendments
in Schedules 6 and 7 that would broaden and strengthen penalties and sanctions
for misleading and inappropriate advertisements.
PharmaCare Laboratories argued that '[i]n the interest of avoiding bias
and to facilitate fair and even-handed treatment of sponsors, no one body
should monitor, regulate and adjudicate on any one issue'.
They were also concerned about a lack of clarity about the circumstances in
which an infringement could be issued.
While the Pharmacy Guild of Australia expressed their support for expanded
enforcement powers and increased sanctions and penalties, they contended that
'the funding and resources currently dedicated to post-market monitoring in
this context are inadequate'.
Free TV Australia was concerned that under Schedule 6, broadcasters
could be held liable for the content of advertisements that are non-compliant.
They also proposed that news and public interest or entertainment programs
should not be considered to be 'advertising', submitting that:
Excluding these programs from the scope of the legislation is
critical to ensuring broadcasters can fulfil the important role they play in
disseminating public health information, promoting the free flow of information
to the public on matters of public interest and to ensure freedom of speech
The Therapeutic Goods Advertising Code already
recognises this and excludes these from the definition of 'advertisement' in
the Code. The Draft Bill should be consistent with this.
Other submitters supported the proposed increases to penalties and
The Australian Dental Industry Association emphasised that the current
regulatory framework has deficiencies in how compliance can be enforced, and
was of the opinion that:
these reforms will act to enhance confidence in the
Australian market for medical devices, something achieved as a result of the
TGA's ability to more effectively enforce the illegal supply provisions within
Complementary Medicines Australia, while recognising that '[t]he vast
majority of industry' tries to comply with the advertising regulations, welcomed
the increased penalties and sanctions, submitting that in conjunction with
post-market monitoring, it would 'set the stage for an effective deterrent
The department emphasised in its submission that the proposed amendments
in Schedule 6 of the TGA Bill would 'be accompanied by an education program to
assist advertisers [to] understand and comply with the new advertising
It also highlighted that the new provisions would allow routine publication of
directions and notices of complaints.
Other issues raised
Several other issues were raised regarding the provisions in the TGA
That, because of the structure of the current regulatory
framework, some sponsors are able to reformulate their products as food to
avoid the requirements of the Therapeutic Goods Advertising Code;
That the proposal for industry education about the changes introduced
by the bill does not include a proposal for consumer education;
That the TGA Bill does not explicitly address the issue of
economic harm to consumers caused by misleading advertisements.
This inquiry received a broad range of submissions with strong arguments
both in favour and against some of the provisions of the TGA Bill, reflecting
the strength of stakeholder engagement in the regulation of therapeutic goods
and the diversity of opinions on issues related to complementary and
The committee acknowledges the significant amount of consultation
involved in the years leading up to the introduction of this bill, including
through the MMDR Review, as well as the time and detailed work undertaken to
ensure that the proposed reforms are appropriate. The committee is of the
opinion that the bill introduces a number of essential reforms to the
regulatory framework for complementary and traditional measures that are in the
Given the urgency of the passage of a number of provisions of the bill
to public health, particularly provisional approval for potentially life-saving
medicines, and the benefits that the TGA Bill will provide consumers with
regard to advertising compliance and enforcement, it is imperative that both
bills are passed. Further, given the varying evidence provided to the committee
on the provisions of the TGA Bill, the committee considers that no matter the
changes proposed, there would be stakeholders who propose a different path to
reform. The bill in its current form provides the best way forward to monitor
advertising, improve compliance, provide members of the public with potentially
life-saving medicines earlier than would otherwise be the case, and encourage
the complementary and traditional medicines industry to provide an evidence
base for their products.
However, the committee is of the opinion that a number of issues raised
to this inquiry need to be addressed. Some evidence contained concerns that
several provisions of the bill involved only limited stakeholder consultations,
sometimes with only limited time given for feedback. Given the importance of
continuing stakeholder engagement to the therapeutic goods regulatory framework,
the committee suggests that the government ensure that the Therapeutic Goods Administration
carries out comprehensive, appropriate and timely consultations with industry
and other stakeholders.
The committee recommends that the government ensure that the Therapeutic
Goods Administration continues to carry out comprehensive, appropriate and
timely consultations with industry and other key stakeholders, particularly in
relation to legislation and regulations affecting the Therapeutic Goods
Administration regulatory framework.
The committee supports the proposed stronger and expanded penalties for
advertisements deemed to be non-compliant. The committee welcomes the
Department of Health's assurances that it will commit the TGA to increased
transparency by providing outcomes of decisions and information for industry regarding
the new penalties regime. The committee notes concerns held by industry that
with the removal of the pre-approval process for advertisements, it would be
subject to stronger penalties and may struggle to adjust to a new regime that
does not identify problematic advertisements before they are published. The
committee is aware that some members of industry would be willing to implement
their own self-regulatory model to ensure that their advertisements are
compliant with the relevant advertising regulations. This approach has merit.
The committee recommends that the TGA investigate ways to further encourage
industry to take this step.
The committee notes the importance of self-regulatory models and
recommends that the Therapeutic Goods Administration investigate ways to better
support the effective functioning of self-regulatory models by industry,
including the potential for further strengthening of the penalties regime if
Although many submitters to the inquiry were strongly in favour of the
enhanced compliance and enforcement provisions contained in the bill, they also
expressed concern that the Therapeutic Goods Administration would not be
adequately resourced to conduct a strong and comprehensive post-market
surveillance regime to ensure that advertisements comply with advertising
regulations. The committee urges the government to ensure that the Therapeutic
Goods Administration has sufficient resources and funds to carry out its new
The committee recommends that the government ensure that the Therapeutic
Goods Administration is adequately resourced in accordance with its
cost-recovery framework so that it is able to carry out its surveillance and
monitoring functions in relation to advertising compliance.
The committee supports the proposed list of permitted indications and is
of the view that this list will lead to increased compliance and protections
for consumers. We note that evidence to this inquiry questioned whether this
list would go far enough in ensuring that medicines listed under traditional
indications do align with the traditions from which sponsors claim they
originate. The committee suggests that in the future, the Therapeutic Goods
Administration investigate ways in which to monitor compliance in this area.
Finally, the committee welcomes the government's commitment to conduct a
three-year review of the bill's provisions, and considers, on balance and in
light of the broad range of evidence and opinions provided to this inquiry,
that this review will be the best method to consider whether the proposed
reforms to the therapeutic goods regulatory framework have had a positive
impact and are working. The committee was not persuaded that essential reforms
should be delayed until this review has taken place, as the purpose of the
review is to examine the effectiveness of the reforms.
The committee recommends that the Senate pass the bills.
Senator Slade Brockman
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