Regulation change in the air
October 28, 2011
THERE is room for improvement to
Australia’s regulatory arrangement
for complementary medicines,
according to the Parliamentary
Secretary for Health and Ageing,
Catherine King.
Speaking at yesterday’s
Complementary Healthcare Council
of Australia’s (CHC) National
Conference, King said that whilst
the govt is proud of Australia’s
regulatory arrangements for
complementary medicines, the
recent Australian National Audit
Office report into the TGA’s role in
regulating complementary
medicines (PD 01 Sep) highlighted
some issues with the system.
These issues, including poor
compliance rates, resulted in
recommendations for improving
the process of regulation for
complementary medicines and the
handling of advertising complaints.
Specific recommendations listed
in the report, including: the timely
completion by TGA of key guidance
material for complementary
medicines; improving the integrity
of the self assessment process for
listing complementary therapies
whilst limiting the use of
inappropriate claims and
indications, have been accepted by
the TGA and are now in the
planning stages for
implementation.
King also said planning is now
occurring for further report
recommendations including making
information available to the public
on each listed complementary
medication; improving the quality
of the regulatory framework
through the use of risk profiles; and
the development of documented
procedures for handling
advertising complaints including
timelines for completing
investigations.
“The government has a
responsibility to ensure that the
regulatory regime for
complementary medicines
continues to strike the balance
between safety and quality whilst
not stifling innovation,” King said.
In addition to the report an
informal working group made up of
industry stakeholders, healthcare
professionals, government officials
and consumer groups, also formed
in response to consumer concerns
over poor complementary
compliance.
This group, according to King,
examined regulatory arrangements
for complementary therapies and
the reasons behind the higher than
expected non-compliance.
The group identified broad areas
for improvement which the
government is now considering.
These areas for improvement
include clarity in the
complementary medicines
framework, after it was discovered
that a lack of clarity led to
confusion by industry members
over what is required of them, as
well as compliance encouragement
due to the fact that the current
system does not “sufficiently
encourage compliance”.
The group also discovered
problems stemming from the
public perception that the TGA has
a higher level of regulation of
complementary medicines than it
actually does.
Possible initiatives to deal with
these issues, according to King, are
currently “being taken into
consideration” .
“The significance that 70% of
Australians use complementary
medicines is not lost on the
government, nor is the fact that this
is a $1.9b industry that contributes
significantly to the broader economy,
and that it employs 5,000 people in
manufacturing and 60,000 others
rely on it indirectly” she said.
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