GSK and Novartis are in
hot water for mislabelling Voltaren Osteo Gel to charge
Fresh from its success in the Nurofen Specific Pain
products proceedings, the Australian Competition & Consumer
Commission (ACCC) is looking for a repeat in bringing
Federal Court for mislabelling of Voltaren Gel. In the
Nurofen proceedings, the Federal Court fined Reckitt
Benckiser (Australia) Pty Ltd $6 million for misleading
On 5 December 2017, the ACCC commenced proceedings
against two pharmaceutical companies, Glaxosmithkline
Consumer Healthcare Australia Pty Ltd and Novartis Consumer
Health Australasia Pty Ltd. The ACCC alleges that GSK and
Novartis misleadingly labelled Voltaren Osteo Gel as
effective for osteoarthritis to charge a price premium,
compared with Voltaren Emugel which has exactly the same
The two Voltaren Gel products are OTC (over-the-counter)
products sold to the public in pharmacies and supermarkets.
The ACCC Media Release – GSK and Novartis in court
for alleged media representations
The Originating Application and Concise Statement have
not yet been published, and so this information is extracted
from the ACCC Media Release:
The ACCC alleges that Novartis and GSK represented
that Voltaren Osteo Gel was specifically formulated for
treating osteoarthritis conditions, and was more
effective than Voltaren Emulgel to treat those
conditions, when the two products are identically
Both products contain the same active ingredient,
diclofenac diethylammonium gel 11.6mg/g, which acts in a
non-specific manner to reduce local pain and
inflammation wherever it is applied.
Price sampling conducted by the ACCC at supermarkets
and pharmacies found that Voltaren Osteo Gel is often
sold at a significant price premium to Voltaren Emulgel.
For example, Votaren Osteo Gel 150g was found
in-store at up to $7.50 (or 33%) more than Voltaren
Emulgel 150g. The recommended retail price of Voltaren
Osteo Gel 150g was $28.99 compared with $25.99 for
Votaren Emulgel 150g.
In 2016 GSK acquired Novartis’ portfolio of Voltaren
products and has been responsible for marketing and
selling Voltaren products since that time.
GSK is the leading supplier of over-the-counter
analgesic products in Australia, with brands including
Panadol and Voltaren.
The ACCC claims that Novartis and GSK made the
alleged false or misleading representations on product
packaging and the website www.voltaren.com.au. The Osteo
Gel packaging shown in the image was in use from about
October 2010 to March 2017.
In March 2017, GSK amended the Osteo Gel packaging to
include the statement “Same effective formula as
Voltaren Emulgel” directly under the product name. The
ACCC alleges that the amended Osteo Gel packaging is
also likely to be misleading.
The ACCC is seeking declarations, injunctions,
pecuniary penalties, a publication order, the imposition
of a compliance program and costs.
What parallels can the ACCC draw between the Nurofen
and the Voltaren labelling?
According to the ACCC Media Release: “The alleged conduct
is particularly concerning, given the significant penalties
handed down by the court against the makers of Nurofen for
what we consider to be similar conduct,” Mr Sims said.
In the Nurofen proceedings - Australian Competition
and Consumer Commission v Reckitt Benckiser (Australia) Pty
Ltd  FCAFC 181, the Full Court (Jagot, Yates and
Bromwich JJ) provided this overview:
The proceeding concerned conduct by Reckitt Benckiser
consisting of representations made on product packaging
and two webpages about a purported range of four
ostensibly different Nurofen pain medications said to be
“targeted” to treat four different types of pain, namely
“migraine pain”, “tension headache”, “period pain” or
“back pain”. In fact, there was no difference between
any of the four products. The products all provided in
the human body a dose of active ingredient equivalent to
200mg of ibuprofen. The only difference was the
packaging and marketing. Moreover, the products were
sold at about double the price of standard Nurofen which
also provided a dose of 200mg of ibuprofen. The price
premium of the products above standard Nurofen was part
and parcel of Reckitt Benckiser’s overall marketing of
the products. (paragraph 5)
Voltaren Gel is a topical medicine applied by hand after
squeezing the gel from a tube. The labelling of the two
products on the package is:
Voltaren Emulgel : For temporary relief of local
pain and inflammation
Voltaren Osteo Gel : For temporary relief of local
pain and inflammation associated with mild forms of
osteoarthritis of the knees and fingers.
It is the osteoarthritis claim in the Osteo Gel together
with the use of ‘Osteo’ in the name that is questioned by
the ACCC. Voltaren Osteo Gel is sold at a price premium of
at least $3.
GSK and Novartis admit that both products have the same
On its face therefore, there are strong parallels with
the Nurofen mislabelling.
What scope is there for GSK and Novartis to argue
their labelling is not misleading?
GSK and Novartis have a line of argument which was not
available in the Nurofen case, namely the caps on the tubes
have different designs.
On the Voltaren Osteo Gel label, there is an illustration
of an easy-to-open cap for the tube. This cap is a
large triangular cap, designed for people with arthritis who
have reduced manual strength and dexterity to open the cap
to access the tube of gel.
The cap on the Voltaren Emugel tube is the standard small
grooved screw cap.
GSK and Novartis are expected to argue that the labels
are not misleading because the capping is a genuine
difference between the two products. And that the triangular
cap justifies the price premium of $3 in terms of
No two cases are the same factually. There are limits to
how far the Nurofen decision can be used as a precedent.
The outcome of the Voltaren proceedings will shed further
light on how pharmaceutical companies need to differentiate
different versions of the same branded products to avoid
being accused of misleadingly charging a price premium for
what is essentially the same product.