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[e-drug] $1.8 million fines for breaches of Medicines Australia Code

E-DRUG: $1.8 million fines for breaches of Medicines Australia Code


In 2007/2008 83 new complaints were received by Medicines Australia. Of
the 83 new complaints received by Medicines Australia, 75 complaints
were considered in 2007/2008.  One new complaint was referred back to
the complainant for further information.

Of the remaining 74 complaints, 71 were finalised in 2007/2008 (three
complaints considered by the Code of Conduct Committee late in 2007/2008
were deemed not finalised as the complainants and Subject Companies had
not had sufficient time to advise of any appeal).

A little of half of these (54%) were found in breach of the Code. Of the
37 complaints found in breach, 34 were found in breach of some aspects
(48%) and 3 complaints were found to be in breach of all aspects (4%) of
the Code.

The average time taken to resolve a complaint was 26 working days.
However, complaint resolution ranged from 16 working days (shortest) to
104 working days (longest). Where a complaint is subject to appeal, the
average time to resolve is increased to 55 working days.

Sanctions for Code breaches included 31 (44%) fines totaling $1.8
million fines, 8 (11%) withdrawal of material or cease activity orders
and 7 (10%) corrective letters or corrective advertisements.

In the period 1 July to 31 December 2007, 14,633 events were held or
sponsored by companies, of which approximately 22% were organised by a
third party organisation and sponsored by a pharmaceutical company.

Following an ACCC requirement to disclose details of educational events,
the Monitoring Committee closely scrutinised events identified as
problematic by an independent auditor; approximately 5% of the 14,633
educational events reported to Medicines Australia.

After evaluating further information provided by each company, it was
determined that 52 events should be adjudicated by the Code of Conduct

Of these, 24 of the 52 educational events were determined to be in
breach of the Code; six appeals were lodged and heard by the Appeals
Committee. Three appeals were upheld (that is, the events were finally
determined not to be in breach of the Code). Therefore, a total of 21
events (0.14%) were finally determined to be in breach of the Code.

Details of all the above can be found at:


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