Consumers Health
Forum OF Australia
SUBMISSION
THE REGULATORY
FRAMEWORK FOR
ADVERTISING THERAPEUTIC
GOODS
December 2016
Consumers Health Forum of Australia (2016r) Title
of submission. The Regulatory Framework for
Advertising Therapeutic Goods Canberra, Australia
P: 02 6273 5444
E: [email protected]
twitter.com/CHFofAustralia
facebook.com/CHFofAustralia
Office Address
7B/17 Napier Close,
Deakin ACT 2600
Postal Address
PO Box 73
Deakin West ACT 2600
Consumers Health Forum of Australia is funded by
the Australian Government as the peak healthcare
consumer organisation under the Health Peak and
Advisory Bodies Programme
Contents
Introduction ....................................................................................................... 4
Key Issues ......................................................................................................... 4
Preapprovals .................................................................................................................................. 5
Sanctions and Penalties .................................................................................................................. 5
C0II1plaints Handling .....................................................................................................................6
Future of Therapeutic Goods Advertising Code, Code Council and Complaints Resolution Panel. .. 6
Industiy Education ......................................................................... Error! Bookmark not defined.
Introduction
The Consumers Health Forum of Australia (CHF) is the national peak body representing the interests
of Australian healthcare consumers. It works in the public interest to achieve safe, quality, timely
healthcare for all Australians, supported by accessible health information and systems.
CHF welcomed the Review of Medicines and Medical Device Regulation. Consumers constantly raise
with us their concerns about safety and quality of medicines and medical devices often giving us
examples of when the system has failed. We have heard some terrible stories. For many people this is
what leads them to be active consumers as they see the need for systemic change and want to be part
of that change.
We have also heard good stories and many consumers acknowledge that the existing regulatory
framework, despite its many flaws, has delivered peace of mind for many Australians when they take
a medicine or use a medical device.
CHF has been an active participant in all stages of the process. We put submissions in response to
both discussions papers from the Panel, participated in the consultations that followed the release of
the Panel’s reports and are participating in the current round of consultations on how to implement the
Government’s preferred positions.
CHF accepts the need for there to be a balance between protecting the consumer and reducing the
burden of regulation. However, throughout this process, CHF has maintained the key principle that
any reforms to the regulations must:
•
•
ensure Australians have access to medicines and medical devices that are of high quality and
safe: and
increase consumer confidence in the regulatory system.
Consumers are often at a disadvantage when it comes to choosing medicines or medical devices in
terms of their access to information and their ability to interpret that information. We have relatively
low levels of health literacy In Australia with less than half the population deemed to have adequate
health literacy. This means people are not able to critically examine the information that is provided
through advertising and other channels and can be vulnerable to pressure from advertisers. This makes
having a robust advertising framework is a key protection for consumers and helps deliver confidence
in the system.
We appreciate that this consultation is about how to implement the Government’s reform package and
so we concentrate on ensuring that implementation focuses on putting consumer interests first. It is
hard to separate out the issues raised in the consultation paper as the recommendations are intertwined
and we have structured our responses in line with the consultation paper.
4 Consumers Health Forum of Australia
Key Issues
Preapprovals
The Government has decided to abolish the pre-approval system for advertisements and move to a
self-regulation model. CHF did not support this in our submissions to the expert panel as we saw it as
an effective method of protecting consumers from inaccurate and misleading advertisements.
However we are now keen to ensure that the new regime does have adequate protections for
consumers and provides for robust sanctions and penalties that do act as a disincentive for
manufacturers.
We see the implementation of those sanctions and penalties as a necessary condition for the removal
of preapproval and so will need to be in place and have been rigorously tested before the preapproval
process is removed. We also think there need a more robust complaint system and that this needs to
be adequately resourced to ensure it can deal with all complaints in a timely way. Having long delays
means misleading or inaccurate advertisements may be able to continue and so have an impact on
consumers for some considerable time.
There needs to be close monitoring of advertisements once the pre-approval is removed to establish
their effectiveness and to see if the removal of the pre-approval has led to an increase in misleading or
inaccurate advertisements. There is nothing in the consultation paper about how the reforms will be
evaluated and this needs to be addressed in the final implementation plan. It needs to include
timeframes for evaluation and CHF suggests there should be a three (3) year review to see what
impact the removal of pre-approvals has had. There also needs to be some agreed benchmarks which
would trigger a re-examination of the process in the future.
The consultation paper also raises the possibility of a self-regulatory framework for vetting of
advertisements to give broadcasters and publishers more confidence in the advertisements compliance
with the regulatory framework. CHF has reservations about the effectiveness of self- regulation but
thinks that the value of such an approach will be tested in the proposed evaluation.
It would be up to the industry to design such a framework and CHF would be urging them to ensure it
involved consumers, in both its design and implementation.
Sanctions and Penalties
CHF agrees with many other stakeholders that the current sanctions and penalties available for
breaching advertising requirements are insufficient to protect the consumer interest and should be
strengthened so they act as a real deterrent for industry.
We support the suite of enhanced investigative and enforcement powers as identified in the
consultation paper. We support the principle that the level of penalty and available sanctions for each
offence and any accompanying civil penalty should be based on the assessed public health importance
of the breach of the requirement.
We believe that the introduction of the power to apply an injunction is a prerequisite for abolishing
the statutory pre-approval process to ensure public safety is protected and consumers have confidence
in the system. There must be an option of taking swift action to have a misleading or false
Submission on The Regulatory Framework for Advertising Therapeutic Goods 5
advertisement withdrawn from publication/broadcast as soon as it is identified. This power would be
used only in those cases where the advertisement is deemed to pose a serious risk to public health or
safety. There will need to be guidance on what types of breach could be the subject of an injunction to
assist industry to assess the potential outcomes of not vetting its advertisements closely enough.
Whilst the injunction could be either temporary or permanent it would start as temporary subject to
future examination before a final determination is give. There is resource implications for this as
there would need to be a timely process to determine the final outcome.
CHF supports the move to have public warning notices in relation to advertising claims that are likely
to cause harm. CHF would encourage the TGA to work with consumers to develop an effective
warning system. This work needs to include looking at what the warning says, how it says it and how
it is publicised so the consumers know about it. There also needs to be a consumer education
campaign to promote the warning system.
CHF has long argued for greater transparency and that the public should be able to find out what
happens to a complaint and if it has brought about the required change in behaviour. We support the
proposal for the TGA to be able to publish information on its website about the complaint and
required action so that there is a full picture of the outcome. We believe this will increase consumer
confidence in the system and encourage people to put in complaints as they will get an outcome.
Complaints Handling
CHF believes that the current complaints resolution process, including the Complaints Resolution
Panel is a good model of shared responsibility involving the key stakeholders including consumers,
health professionals, and industry and media organisations. Its independence from the regulator has in
fact been its main strength. Many of the problems identified with this model are actually a function of
lack of resources and lack of enforcement powers rather than the composition of the panel and its
modus operandi.
If there is to be a change then CHF supports the establishment of a single complaint handling scheme.
We believe that the TGA is best placed to take responsibility for a new centralised advertising
complaints handling process. Our support for this option is primarily because we believe there should
be as a close a link as possible between the complaint handling and the exercising of the statutory
powers for effective and efficient net exercising of those powers. We also think the setting up of a
new complaints agency, through a tender process, would be expensive and the benefits accruing
would not outweigh the additional costs.
The TGA will need to be resourced appropriately particularly if it is to ensure timeliness of complaint
handling. There will also need to be a shift in culture in the TGA to make it more consumer focused
and that cultural change takes time and resources. We don’t think you can switch over night from the
current process to a new TGA one and so we would support a transition process which kept the
current Code Council and Complaint Panel until the TGA had established its new function and had
demonstrated that the required cultural change had occurred.
Conclusion
As stated earlier we believe that the focus of the reforms needs to be on improved patient safety and
increased consumer confidence in the system. We also believe that any reforms should improve the
6 Consumers Health Forum of Australia
system and not be undertaken simply for change sake. From the feedback CHF receives consumers
do not have complete confidence in the current advertising framework and so we accept that it needs
some reform. We believe that overall these reforms will have a positive impact on consumer
confidence.
We would like to see a review of the reforms to see what impact they have had on the number of
complaints, the number of penalties applied and consumer confidence. We have suggested a three
year time frame for that review as giving long enough for the advertising reforms to be in place for
trends in indicators to become apparent. Any longer and there is the risk that serious failures in the
system will not be picked up and damage done before there is remedial action.
Submission on The Regulatory Framework for Advertising Therapeutic Goods 7