Eleven complaints — what three years of published outcomes say about the price of a breach.

The schedule of fines in § 15.6 tells you the most a breach can cost. It does not tell you what one usually costs, how many fines a complaint draws, or how often the Committee reaches for "severe". For that you read the outcome reports — which Medicines Australia publishes for every complaint the Code Committee adjudicates, and keeps on its site for three years. There are eleven there today. This is what they say when they are read together.

The eleven

Medicines Australia's rule is that it "publishes all complaints which have been adjudicated by the Code of Conduct Committee in the last three years"; complaints referred elsewhere or withdrawn are not published, only tabled in the annual report. The current window runs from March 2023 to April 2026.

Three things are visible before opening a single report. The rate: eleven adjudicated complaints in three years — three or four a year — which is the whole of the Australian system's public case law for promotion. The subject: nine of the eleven are promotional material or promotional claims directed at healthcare professionals, the ground of § 1 and § 2; the exceptions are a consumer media statement § 10.1 and a patient communication § 12. And the gaps in the numbering — 1175 and 1178 are missing — which are the complaints that were withdrawn, referred, or otherwise never reached a Committee finding.

What the reports say about money

Reading the reports for complaints 1159 to 1180 — the current window and the two years before it — gives a picture the schedule alone cannot.

One fine per complaint, not one per breach. The schedule lists a maximum per breach and a $300,000 cap per complaint § 15.6(b), which reads as if fines accumulate. In practice the Committee sets a single figure. Complaint 1173 records "a single monetary fine encompassing all breaches, in the amount of $150,000"; complaint 1177 found five breaches across three materials and imposed one fine of $150,000. Summing the schedule's ceilings for each breach in a piece overstates the exposure every time.

The money clusters in the middle. Across the twenty-two complaints, the median fine is about $130,000. Moderate breaches — no safety implication, a possible moderate effect on prescribing — are the common finding, and they have drawn between $100,000 and $150,000 in eleven of the cases we read. The "severe" grading is rare: two findings in fifteen, and one of those, complaint 1171, was set at $100,000 with the Committee's own note that it sat at "the lower end of the severe category". The high mark of the modern era is $200,000, for Beovu in 1160, before the current window. The $250,000 lines in the schedule — a severe breach with no opportunity to correct, a repeat — have not been levied in this period, and the $300,000 cap has not been reached.

An appeal moves the number. Complaint 1169 was set at $250,000 by the Code Committee and reduced to $175,000 on appeal — the largest movement in the window, and a reminder that § 15.7 is a rehearing, with a $20,000 bond § 15.7(h) against a possible $75,000.

Procedural money is the additive case. Complaint 1180 is the first in the window to fine the complainant: alongside the $130,000 imposed on the subject company, the complainant was fined $80,000 for failing to follow the Intercompany Dialogue Standards § 15.5. That line of the schedule was new in Edition 20, and it is now live.

The package is more than the fine. Every breach finding in the window carried withdrawal of the material and publication of the outcome. Corrective letters, which the schedule treats as a standard sanction, appeared in five of fifteen breach findings and in none since October 2023. The Committee's own note on sanctions says why: it applies them "as a package", with a lower fine where a corrective letter is required, and it names reputational impact as possibly "the most significant consequence for many companies". The report on the website, with the company's name and the reasons, is the sanction that lasts.

What the Committee says it weighs

In August 2025 Medicines Australia published the Committee's sanction-setting principles as a Help Desk note (#94). Three principles: transparency — the Reasons for Decision explain the basis; consistency with flexibility — the Chair has access to previous similar complaints; proportionality — sanctions are a package. The factors: the nature and extent of the breach, the breadth and length of the campaign, the number and type of breaches, and the context. And the company's own conduct: compliance with its own training, whether it admitted the breach, what it did to remediate, how cooperative it was, and whether there is a pattern.

Put beside the numbers, the note explains them. Severity is assigned first, by the schedule's definitions — safety implications, effect on prescribing § 15.6 — and the figure is then placed low, mid or high within the band by the factors above. A company that withdraws early, admits what is plain, and shows the training and the review file it had in place is arguing for the bottom of a band it cannot leave.

What to take from it

• The published record is small and readable — eleven reports — and every one of them names the material, the claim, the clause and the reasoning. A reviewer who has read them knows what the Committee looks for better than any checklist can tell them.
• The 24-month lookback in the Intercompany Dialogue Standards means anything in market in the last two years is complainable; the three-year publication window means a finding follows a brand for longer than most campaigns run.
• Withdrawal and publication are certain; the fine is variable; the corrective letter is rare. Plan for the first two.
• The § 15.5 fine is real money now. A complainant's process failure costs it $80,000 in the one case on record.

Building the case either way — the complaint or the response — is the same work: each claim against the PI, the evidence and the clause, written the way the Committee reads it. That is what Contender does with a competitor's piece, and the complaints guide carries the process it feeds.

Fines and gradings above are our reading of the published outcome reports for complaints 1159–1180; the eleven current reports are linked from the sources. Where a report is the authority, read the report.