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The Australian Competition and Consumer Commission and the
TGA
by Joshua Shaw
Attention: MARKETERS, MANUFACTURERS & IMPORTERS OF THERAPEUTIC
PRODUCTS & ALTERNATIVE MEDICINES
Would you knowingly allow Drug Companies to control your marketing
campaigns and your access to the public? A proposed new Advertising
Code will drastically affect your business! This unfair legislation
can wipe out your company!
Bionic Products Pty. Ltd., manufacturers and sellers of ELANRA
negative ionisers, is taking a stand the proposed new code which
may become a part of the Therapeutic Goods Act. This new code
will suppress your right to complete fairly in an open market
and can even result in the complete destruction of your business.
Its vitally important you understand the implications and offer
your support.
- Bionic succeeded in altering the previous proposed advertising
code for therapeutic goods in 1988 by appealing to the Trade Practices
Tribunal.
- Their successor, the Australian Competition Tribunal, is now
considering new advertising legislation which will put control
in the hands of bureaucracy and your competitors to effectively
stifle competition throughout Australia.
- Under the Codes definition advertising includes: pamphlets,
brochures, magazine articles and paid advertising in any media.
It does NOT include material circulated to medical practitioners,
pharmacists, dentists, veterinarians, nurses, physiotherapists,
accredited medical scientists, hospital purchasing officers etc.
(Apparently, these are the only people intelligent enough to decipher
promotional material without help.)
- The new code has been drafted - and will be administered -
by various stakeholders including the Proprietary Medicines Association
of Australia (PMAA) and the Nutritional Foods Association (NFAA).
The PMAA claims to represent pharmaceutical companies. None of
the Competition Tribunals material satisfactorily explains who
is represented by NFAA.
- Bionic is deeply concerned that drug companies will exert
major control over the Code and will administer it by means of
a Code Council on which they have half the votes. Thus competitors
to natural therapies will have the opportunity to oppress those
businesses if they choose.
- The new Therapeutic Goods Advertising Code is not one by which
industry self-regulates. In reality, it is controlled by the Therapeutic
Goods Administration (TGA). Bionic is seriously concerned about
the composition of the proposed new council and whether it will
in fact be representative of the industries covered by the new
Code.
- The Code is riddled with anomalies and restrictions. It effectively
prevents advertisers from making any claim in regard to the benefits
of their products, unless permission is given in writing by the
Department of Human Service and Health.
- Many products with good scientific credentials cannot gain
this approval and will not be permitted to advertise.
- Section 7 of the Code prohibits many statements, including
claims that a product is safe to use, or that it is more effective
because it occurs naturally. Why should this be against the law
- because it could imply superiority to synthetic products?
- Testimonial statements from users cannot be published unless
they can be proven, and where accepted medical evidence is not
in conflict with the testimonial. Bionic points out that, in its
own case, there is a great quantity of respectable scientific
information to support the use of negative ionisers but because
this is not accepted by the designated medical body (National
Health and Medical Research Council) statements from consumers
testifying to these benefits cannot be published.
- Manufacturers of other alternative remedies will find there
is similar entrenched opposition to products that compete with
traditional medicines - i.e. that reduce the publics dependence
on doctors and pharmacists - yet the TGA expects this very group
to provide objective evidence to support alternative products.
- The Code places an absolute embargo on reference to an exhaustive
lists of ailments. ANY reference to many common conditions and
illnesses is forbidden.
- These matters give a ready opportunity to competitors to complain
to the TGA, who will then act to prevent further advertising.
This has already happened to Bionic.
- There is a Register of Therapeutic Goods divided into two
parts. One relates to registered goods (basically drugs) and one
to listed goods (e.g. personal massagers). ELANRA is a listed
device. No-one who is in any way associated with the manufacture
or marketing of a listed device may advertise that device for
an ailment other than those accepted in relation to the register.
Yet the new code prohibits any advertising that mentions ailments!
- The consequences of breaching the advertising code are the
threat of having a listed product removed from the Register, making
it a non-listed product. Non-listed goods cannot be advertised
as having any therapeutic benefit. For Bionic, and for similar
products, this would mean the annihilation of the company.
- Members of 27 associations including Chinese Medicine Practitioners,
Homoeopaths, Trichologists, Naturopaths etc. may well be exempted
from the restrictive provisions of the new advertising code, giving
these people a competitive advantage. This shows the Code is not
a strict regimen applying equally to everyone. However:
- The Complimentary Medicines Association has applied for additional
substances to be included in the list of products covered by proposed
restrictions. Many of these are traditional medicines used by
members of the above groups e.g. herbal substances, homoeopathic
preparations, non-human animal tissue, bee products etc. People
who retail or wholesale such products will then be affected by
advertising restrictions.
- Anyone breaching the new Code can be ordered to cease advertising,
to publish a retraction and apology, castigated in the trade press
and fined. The committee deciding such matters will deliberate
behind closed doors.
- An offender may appeal against the committees decision, but
if the appeal is dismissed he/she has no recourse, not even through
the courts.
- Should the TGA decide that your advertising claims breach
their laws, whether or not you are aware of these laws, you can
be prevented from promoting your product(s) to your specialist
market and/or the public.
- Members of the public should be aware that this legislation,
if it proceeds, will limit access to vital information on alternative
goods and therapies. Free choice will be severely restricted.
A Hearing at the Australian Competition Tribunal will take place
in Sydney on 19th November 1997. Any person affected by this legislation
can seek leave to intervene and to state their case in a court
action scheduled for February 1998.
WE NEED YOUR SUPPORT TO FIGHT THIS LEGISLATION!
For the full document detailing the implications and offering
legal analysis, contact Bionic Products Pty. Ltd. Phone (07) 5593
1122 P.O. Box 555, Robina QLD 4226
STOP PRESS 12 November 1997:
At a meeting instigated by the Proprietary Medicines Association
at 10.30 today, Mr John Cable, a senior TGA executive, stated
to our solicitor that the TGA's intention was now to bypass authorisation
by the Australian Competition Tribunal and have the new code passed
by Parliament without further discussion.
This is contrary to the stated policy of the former Parliamentary
Secretary to the Minister for Health, Mr Bob Woods, who, in a
media release in December 1996 stated that:
Health Professionals and consumers would have to be closely involved
in the establishment of a code of conduct, which would also have
to be endorsed by the Australian Competition and Consumer Commission.
At the Directions Hearing on the 19th November 1997 the Commonwealth
Solicitor will be requesting an adjournment of the hearing to
enable this legislation to be passed in Parliament before Christmas.
At that time of the year, our ability to alert the media to the
implications of this legislation will be almost impossible. If
this legislation is passed, individuals and groups within the
natural health care industry will be at the mercy of draconian
legislation, and will have no avenue of appeal.
By the 1st December, politicians will be leaving for their Christmas
break.
You must act now!!
Phone, write or fax your Federal Member today to register your
protest against this dangerous legislation!
Visit Bionic Products Webpage. http://xenios.qldnet.com.au/~bionic
Joshua Shaw
Bionic Products Pty. Ltd.
P.O. Box 555
Robina, Queensland 4226
(07) 5593 1122
bionic@qldnet.com.au