E-DRUG: Reform of Australian Therapeutic Goods Administration (2)
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'TGA all bark no bite as Labor botches response to a series of reviews'
The Coversation
December 8, 2011
Ken Harvey
The government has just announced its response to a series of reviews of
the Therapeutic Goods Administration over the past 18 months. The
announcement was brought forward after a summary of the reforms was
accidentally emailed to about a dozen people yesterday.
Transparency review and devices
Most recommendations of the TGA Transparency Review will be implemented.
These include the establishment of an Australian therapeutic goods
advisory council for oversight of the implementation, ongoing
monitoring, and evaluation of review recommendations over the next four
years. A dedicated communications unit will also be created within the
TGA to inform and educate the public.
Some positive moves regarding the regulation of medical devices include
reclassifying the load bearing component of a hip, knee or shoulder
joint replacement from medium-high risk to high-risk. This means such
devices will require more assessment before entering the market.
The information on medical devices on the Australian Register of
Therapeutic Goods (ATGR) will be amended so sponsors will nominate names
for each product. This will make it easier for consumers and health
professionals to find information about specific devices. The amount of
available product information on the TGA website relating to medical
devices will also be increased.
However, a key concern of the Working Group on Promotion of Therapeutic
Goods (to health professionals) that compliance with an industry code
should be a condition of including a product on the ATGR was not
accepted. The government's view was that this departs from their
prefered self-regulatory model. However, group members noted that the
worst perpetrators of unethical promotion were usually not members of
industry associations and these cowboys would be unlikely to sign up to
code compliance voluntarily.
Without addressing this problem, the likely outcome of "strengthening"
and creating a "level playing field" for self-regulatory codes is that
the good guys (industry association members who are code compliant) will
increasingly be restrained while the bad guys (non-members of industry
associations) will laugh all the way to the bank.
Not addressing this concern also perpetuates the difference between
health professionals and industry. Health professionals now have
government-mandated national registration and must comply with
Australian Health Practitioner Regulation Agency (AHPRA) code while the
latter (non-members of industry associations) have no controls placed on
them at all.
The recommendation that the effectiveness of voluntary registration be
evaluated annually required government acceptance of a number of other
recommendations, such as creating an advisory group. But apparently
"[the government] is not yet persuaded there is a need to establish a
permanent advisory group" and "aspects of the Report which require
either Government assistance or legislative amendments to move towards
co-regulation have not been accepted by the Government at this time".
Given this background, I cannot see how it'll be possible to evaluate
the impact of Working Group on Promotion of Therapeutic Goods
recommendations or how "longer term changes will be considered if
necessary". But perhaps that was the aim of rejecting these key
recommendations. So what was the point of setting up a broad-based
stakeholder "Working Group on Promotion" and then ignoring their key
concerns and recommendations?
Complementary medicines
There are positive measures for the regulation of complementary
medicines and information provision, which include:
amending the Therapeutic Goods Regulations with guidelines for the
levels and kinds of evidence required to support claims;
changing the way products are electronically listed so sponsors can't
just add free text; and
working with stakeholders to create better labelling.
However, it's disappointing that clear labelling requested by many has
been assigned to further work with stakeholders. What's required to
assist consumers making decisions about complementary medicines is a
clear statement on the label, on promotional material and above the
shelves with complementary medicines that honestly reflects the
regulatory reality.
Indeed, the TGA media spokesperson has recently been using an useful set
of words, "The TGA does not evaluate the effectiveness of listed
complementary medicines and cannot guarantee that these products work".
This labelling reform can and should be implemented now -- why further
delays?
Advertising reforms (promotion to consumers)
This was the most disappointing area of all. For the last decade,
numerous reports to government and submissions from consumers and health
professionals have highlighted the need to ensure that the Complaints
Resolution Panel (CRP), on its own or along with the TGA, can readily
apply escalating and effective sanctions on product sponsors who breach
the Therapeutic Goods Advertising Code and Therapeutic Goods Act.
But the government response is -- "changes to the approach of sanctions
and penalties for advertising breaches, including civil penalty
provisions which parallel offences and act as a deterrent, will be
investigated."
Currently, the CRP is under-resourced, overloaded and has no power to
enforce sanctions. Sponsors are merely "requested to comply". It takes
between six and nine months for complaints to be heard and judgements to
be made public. All this takes place while misleading promotion
continues. The CRP also lacks resources to follow up its own decisions,
which make them more easily ignored.
It often takes multiple complaints before non-compliance by a product
sponsor is passed to the final regulator -- the TGA. The TGA may write
letters "ordering" compliance but, due to the low financial penalties
available, it has never prepared a brief of evidence for consideration
of prosecution (see ANAO report).
Paper tigers
Industry knows that the CRP and TGA are paper tigers, so serial
advertising offenders and conmen flood the market with dodgy products,
undeterred by escalating (and ultimately ineffectual) complaints.
Recently, SensaSlim (and other shonky products) have been referred from
the TGA to the Australian Competition and Consumer Commission (ACCC),
but this has, as yet, failed to stop the continued sale of these
products or their imitators, or their use.
We need legislation to give the CRP and TGA timely and meaningful
sanctions for advertising violations (civil penalties, enforceable
undertakings) now. I cannot see why "further investigation" and "further
input by stakeholders" is needed apart from the sake of letting sections
of industry profit by continuing to rip off consumers unchecked.
Like the Curate's egg, the government's reform blueprint appears to be
good in parts. But it also displays a timidity to grapple with key
issues, such as therapeutic goods advertising reform, and that seems to
be a common failing of this Labor government.
I've been a card carrying member of the Labor Party for some time. I
worked hard to get rid of the Howard government and get Labor elected
and I've sat on a number of the working parties and consultations that
have made the recommendations outlined above.
But I can no longer be a member of the party when a Labor government
fails to implement unanimous recommendations from its own working
parties, and continues to procrastinate after a decade of calls for
effective sanctions on advertising violations. I have today submitted my
resignation.
--
Ken Harvey
Medreach
Australia
Ken Harvey <k.harvey@medreach.com.au>