1.1
The Australian Greens referred the Therapeutic Goods Amendment (2017
Measures No. 1) Bill 2017 to the Senate Community Affairs Legislation Committee
for inquiry in report due to the significant concerns raised about the
stakeholder consultation associated with the bill, as well as specific concerns
relating to Schedule 2 and Schedule 6 of the bill.
Consultation
1.2
The Australian Greens note the concerns raised about the consultation on
the measures in this bill. Many submitters to the inquiry have highlighted that
while there has been some consultation associated with reform options prior to the
bill being introduced into Parliament, the wide range of views and concerns
have not been adequately represented in the drafting of the bill.
1.3
It is noted that while the Department has categorised all the amendments
in this bill as arising from the Expert Review of Medicines and Medical Device
Regulation (the Sansom Review), some elements of the bill go further than what
was recommended in the report of that review, and indeed seem not to have taken
into account the legitimate concerns of some stakeholders about the
implications of these reforms.
1.4
The Senate inquiry has provided a further opportunity for stakeholders
to highlight their concerns, and yet the majority report has once again
disregarded these concerns and recommends that the bill pass the Senate in its
current form.
1.5
The Australian Greens recognise that the concerns of stakeholders require
consideration given the significant implications of the proposed changes to the
regulation of complementary medicines for Australian patients and consumers.
These stakeholders include the Consumers Health Forum, Choice, and Associate
Professor Harvey and Professor Braithwaite.
Permitted indications and lack of disclaimer
1.6
Schedule 2 of the bill would enable the Minister to determine a list of
'permitted indications' that can be made for medicines listed in the Register
(complementary medicines).
1.7
Currently, the process for 'listing' a complementary medicine on the
Australian Register of Therapeutic Goods (ARTG) allows the sponsor company to
include a 'free text' description of the indications for that product. Schedule
2 proposes to remove the 'free text' option and replace it with a power for the
Minister, via legislative instrument, to establish a list of pre-approved
'permitted indications' which sponsors can use to promote their products,
without any assessment from the Therapeutic Goods Administration (TGA).
1.8
The Australian Greens share the concerns of a number of stakeholders who
have raised concerns in their submissions about the implementation of this
proposed new approach, in particular given that the Sansom review had made a
supplementary recommendation for a prominent disclaimer to also appear on the
pack of complementary medicines, alerting consumers of the lack of testing for
efficacy.[1]
1.9
For example, in the submission from the Consumers Health Forum it is
stated that:
Our concern is that the limitations of this list of permitted
indications may not be understood by many consumers and it may give them some
misplaced confidence in the evidence behind the list. If the proposal [had been
adopted] from the Review of Medicines and Medical Device Regulation that there
should be a disclaimer on all listed complementary medicines making it clear
that the efficacy claims had not been independently verified, then this would
not be such a problem.[2]
1.10
This call is echoed in a range of submissions including the Royal
Australian College of General Practitioners (RACGP) who state that:
We strongly recommend that the TGA mandates that
manufacturers must include a statement to accompany all non-scientific
therapeutic claims, in close proximity and in the same font as the health
claim.
The mandated statement should read similarly to the US FTC
example...:
'This product's traditional claims are based on
alternative health practices that are not accepted by most modern medical
experts. There is no good scientific evidence that this product works'.
We note that this recommendation will not impede any
manufacturer from choosing to market their product to people with a particular
health condition. It merely provides the consumer with information that
protects them from being led to believe that the health claim is backed by
scientific evidence.[3]
1.11
The Sansom Review recommended that:
...where a medicinal product is listed in the ARTG under Option
One (self-assessment), the sponsor is required to include a prominent
disclaimer on all promotional materials relating to the product, including
product information on websites, to the effect that the efficacy claims for the
product have not been independently assessed and/or are based on traditional
use.[4]
1.12
This recommendation was made to work in correlation with the
introduction of a permitted indications list, to ensure that consumers have the
information they need to understand the level of regulatory oversight that is
applied to the efficacy claims for listed, or complementary medicines. The
Australian Greens are disappointed that this recommendation was rejected by the
Government in its response to the Sansom Review. As a consequence of this
decision, the bill proposes to introduce a lengthy list of permitted
indications without the accompanying disclaimer.
Recommendation 1
1.13
The Australian Greens recommend that Schedule 2 of the TGA Bill be
amended to require that sponsors include a disclaimer on their ARTG listed
medicines under Option One, as set out in Recommendation 44 of the Expert
Review of Medicines and Medical Devices Regulation Report.
Deregulation of advertising and removal of preapprovals
1.14
Schedule 6 of the TGA Bill proposes to remove the current system of
pre-approvals for advertisements of therapeutic goods. Currently, proposed
advertisements are submitted to a pre-vetting process, under a power delegated
to the Australian Self Medication Industry (ASMI) and Complementary Medicines Australia,
to ensure they meet the approved standards.
1.15
Numerous submitters to the inquiry have raised concerns about the
removal of this current layer of oversight. The current system guards against
the distribution or broadcast of advertisements in breach of the relevant
regulations and protects consumers from misinformation about the efficacy or
indications of products.
1.16
The current need for the pre-approvals process is outlined in the
submission from ASMI:
ASMI estimates that 60 – 70% of advertisements submitted to
the ASMI Advertising Services Office for pre-approval, require some form of
amendment, ranging from relatively small amendments to major reviews of
advertisements. Without pre-approval 2 serious adverse consequences arise:
- First, consumers would have been exposed to
those non-compliant advertisements and may suffer adverse health or economic
impacts.
- Secondly, sponsors face potentially very
expensive revisions to marketing campaigns after launch. Campaign costs range
from $200,000 to $10,000,000 and while large member companies have the
resources for extensive compliance checking, a significant burden will fall on
firms at the smaller end who have limited regulatory and compliance resources
and have come to rely on ASMI providing a review function.[5]
1.17
The Australian Greens concur with the concerns of stakeholders including
CHF, Choice, Friends of Science in Medicine, Access 2, Public Health
Association of Australia (PHAA), ASMI[6],
that there is little sense in removing this layer of regulatory protection, at
the very least until the effectiveness of the new sanctions for breaches have
been assessed and reviewed through the formal three year review of the reforms.[7]
Recommendation 2
1.18
The Australian Greens recommend that the removal of pre-approvals for
therapeutic goods advertising be delayed at least until after the three year
review of the broader reform package.
Senator
Rachel Siewert
Deputy Chair
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