The Medicines Australia Code of Conduct guides the promotion of prescription products by pharmaceutical companies.1 Each year Medicines Australia publishes a report, from its Code of Conduct Committee, which details all the complaints that have been received about advertising and other promotional activities. The Table shows the complaints where at least one breach was identified, and more details can be found in the full report.2 These complaints were dealt with under the previous (17th) edition of the Code of Conduct.
This year the largest fines related to promotional events. At one event an international guest speaker gave a presentation which the majority of the Code of Conduct Committee considered was aimed to encourage discussion about the off-label use of a drug. One company was fined for organising a presentation skills course for three specialists, while another was found not to have breached the Code for taking specialists to visit a factory in Puerto Rico.
An unusual case involved a doctor who complained about not receiving visits from company representatives, not being provided with samples and not being invited to the company’s educational events. These complaints and a subsequent appeal were not upheld.
The 18th edition of the Code was implemented this year.1 Pharmaceutical companies will now post online information about the payments (including educational support through airfares, accommodation and conference registration fees) they make to health professionals. For the first year health professionals have to consent to the disclosure, but from 1 October 2016 it will be mandatory for the industry to report any payments.
Table Breaches of the Code of Conduct July 2014 – June 2015
Company
|
Brand (generic) name
|
Material or activity
|
Sanction
|
Bayer
|
Nexavar (sorafenib)
|
Misleading detailing aid
|
$10,000 fine Material withdrawn
|
Bayer
|
Xarelto (rivaroxaban)
|
Misleading advertising
|
$30,000 fine Material withdrawn
|
Bristol-Myers Squibb
|
Sprycel (dasatanib)
|
Misleading promotional material
|
$45,000 fine Material withdrawn
|
GlaxoSmithKline
|
Seretide (fluticasone propionate/salmeterol xinafoate)
|
Fictitious patient quotes
|
$40,000 fine Material withdrawn
|
GlaxoSmithKline
|
Votrient (pazopanib)
|
Misleading advertising
|
$20,000 fine Material withdrawn
|
iNova Pharmaceuticals
|
Duromine (phentermine)
|
Inappropriate information at educational event
|
$100,000 fine Corrective letter to participants
|
Novartis
|
Lucentis (ranibizumab)
|
Inappropriate educational event
|
$90,000 fine
|
Novartis
|
Ultibro breezhaler (indacaterol/glycopyrronium)
|
Media release
|
$30,000 fine
|
Shire
|
Mezavant (mesalazine)
|
Unbalanced promotional material
|
$20,000 fine Material withdrawn
|