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[e-drug] Glaxo fine and the 17th Edition of Medicines Australia Code

E-DRUG: Glaxo fine and the 17th Edition of Medicines Australia Code

[This message also relates to the message chain: Glaxo to pay $3 bn for largest 
health care fraud in US. DB]

Dear All

Not surprisingly, these two news items led to a discussion on Australian
television (and elsewhere) of whether the promotional activities of the
pharmaceutical industry should be governed by self-regulatory industry codes
of conduct or by co-regulation involving the government and other

The latest edition of Medicines Australia (MA) Code contains a number of
incremental improvements, for example requiring member companies to report
in aggregate amounts:

.  All payments made to healthcare professionals for advisory boards and
consultancy arrangements; 
.  All sponsorships of healthcare professionals to attend medical
conferences and educational events ;
.  All payments made to speakers at educational events; 
.  All sponsorships of all individual consumer organisations for each
financial year, including the value of non-monetary support.

However, this falls far short of the full disclosure of individual payments
made to healthcare professionals which many consumer and health professional
groups have argued for both in the 16th Edition (2009) Code revision and
again in the 17th Edition (2012) Code revision. Over this time, a number of
Australian pharmaceutical companies had also become comfortable with full
individual disclosure of payments to healthcare professionals along the
lines of the U.S. Physicians Sunshine Act;  however this was not
incorporated in the latest MA code.

This illustrates one of the problems of self-regulation, codes often lag
behind consumer and health professional views due to the absence of these
stakeholders from code revision committees. Codes also lag behind the views
of progressive pharmaceutical companies because of the need for revisions to
be approved by a majority of member companies. 

In addition, in Australia a plethora of therapeutic industry associations
results in a variety of self-regulatory codes with code content, monitoring,
complaint procedures and transparency varying greatly ("not a level playing

Another problem of self-regulation is relatively weak sanctions. MA's
maximum fine of  $300,000 (with an average fine of $50,000) stands in stark
contrast to the recent GSK fine of $3 billion by the U.S. Justice
Department.  The U.S. False Claims Act also encourages whistle-blowers to
provide crucial "insider" evidence about corporate fraud as they are
rewarded with between 15% and 30% of whatever proceeds the government
recovers from a successful  civil suit. There are no such incentives in

A further problem with self-regulatory codes is that they don't apply to
non-members; a major problem in certain areas of the Australian therapeutic
goods industry. For example, earlier this year Ranbaxy Australia offered
pharmacists A$14,648 of free TrovasR (generic atorvastatin) stock; an offer
that  would appear to breach the codes of both the Generic Medicines
Industry Association (GMiA) and Medicines Australia. However, as Ranbaxy
Australia Pty Ltd was not a member of any self-regulatory industry
association no complaint could be heard!

The latest MA Code has now passed to the Australian Competition and Consumer
Commission (ACCC)  for authorisation. This will provide another opportunity
for health professional and consumer input. In the past, the ACCC has
imposed "conditions" when authorising MA's Code which have strengthened its
provisions; it is hoped the same may occur with respect to individual
disclosure of payments to healthcare professionals. 

Other changes to the 17th Edition of MA's Code, include:

.   A ban on all brand name reminders for healthcare professionals
.   A ban on competition prizes for healthcare professionals
.   An explicit ban on all personal gifts to doctors such as chocolates and
.   A new explicit requirement for companies to adhere to an International
Federation of Pharmaceutical Manufacturers and Associations (IFPMA) global
position on disclosing clinical trial information and publishing clinical
trial results in scientific literature.
.   A requirement that any payments to healthcare professionals in relation
to patient support programs is disclosed to patients.


For more debate about the Code, see:



Dr Ken Harvey
Adjunct Associate Professor
School of Public Health, 
La Trobe University 
VOIP (03) 90293697 | Mobile +614 1918 1910 | Fax: +613 9818 1875

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