Complaints under the Code — intercompany dialogue, the letter, the committee.

Most affiliates have a complaints SOP and most of them were written for Edition 19. They describe a letter to the other company, a phone call, and a submission to Medicines Australia — and they are silent on the thing Edition 20 made binding: the Intercompany Dialogue Standards, a formal process with a defined first letter, a 35-working-day clock, a signature requirement and a $100,000 fine for not following it. This guide is the whole complaints lifecycle in the Code's own words — both directions, since the affiliate that sends a complaint this year will receive one the next — with the letter that starts it drafted in the shape the Standards want.

Two ways in

The Code gives a complaint two doors, and they are not the same.

Anyone can complain. A healthcare professional, a patient, a competitor's sales representative, a journalist. Section 15 opens by describing "a robust and independent complaint and appeal process where all parties are entitled to fair and equitable treatment" § 15. The Complainant "has the burden of proving their complaint on the balance of probabilities" § 15.1(a); "anonymous complaints will not be accepted" § 15.1(b). For a non-industry complainant the Tool Kit's Guidelines for Non-Industry Complainants make the process free, provide an Independent Facilitator for up to two hours, require no bond, and keep the complainant's name out of the published outcome. Contacting the company first is encouraged but not mandatory.

A company complaining has a prerequisite. "For Company-initiated complaints, Companies will follow the Intercompany Dialogue Standards, which are described in the Code Tool Kit. Medicines Australia will not accept a complaint from a Company unless it has been clearly demonstrated that intercompany dialogue has taken place and the complaint has not been resolved" § 15.1(c). A non-member company lodges a $20,000 bond with its complaint § 15.1(d), refundable in whole, part or not at all at the Committee's discretion § 15.1(e).

Three more gates apply to both. Medicines Australia may decline a complaint "if the subject matter has been substantially dealt with by the Code Committee" § 15.1(f) — the same sections against the same material, whether or not a breach was found; revised material is a new matter. Where the same subject is before the TGA or a court or tribunal between the same parties, it may decline, or accept and hold § 15.1(g). And everything stays confidential "until the Subject Company and Complainant have exhausted all appeal procedures and the outcome of any appeal is known" § 15.1(h).

The Standards add a lookback: material or activity more than 24 months old at lodgement will not be accepted unless it was still in use.

Before the letter

The Standards govern the formal dialogue, which begins with a document they call the Formal Written Complaint. Everything before it — an e-mail, a call between medical directors — is informal, encouraged, and often the end of the matter. Everything after it is on the record: once formal dialogue starts, all communications between the companies are documented as part of the ICD record that goes to Medicines Australia.

Two things to settle before the first formal letter goes.

Whether it is a complaint at all. The Code will "not tolerate misuse of the process" § 15.4. A complaint, or "a series of complaints by a single Complainant against one or more Companies within a therapeutic class", may be found frivolous or vexatious "regardless of whether or not the complaint or complaints are sustained" § 15.4(b), § 15.4(c), and the schedule of fines carries $100,000 for it § 15.6. The Standards say it directly: intercompany complaints must not be used as a competitive tool. The test to apply before drafting is the one a Code Committee applies afterwards — would the piece mislead a prescriber, or does it merely annoy a brand team?

Its scope, exactly. The first letter "establishes the scope of the ICD and the scope of any future complaint that might be submitted to Medicines Australia", in the Standards' words. It cannot be widened afterwards except by documented mutual agreement, and then only to more examples of the same claim in materials already described. A different claim — in the same piece or another — is a new complaint with its own letter and its own clock. So the letter has to carry everything: every material, every claim, every clause, every reference. A complaint that finds a second problem after sending is a complaint that starts again.

The letter

The Standards set four things the Formal Written Complaint must contain — the materials, events or activities subject to complaint; the issues raised; the Code section, sub-section, requirement or principle alleged to be breached; and the references relied on — and one thing it must be: clearly identified as the Formal Written Complaint, since that heading is what starts the clock. Everything else about its form is the affiliate's. This is the shape we use.

Intercompany Dialogue — Formal Written Complaint

[Date] · Ref. [Complainant's file reference]

To: [Name], Managing Director / Medical Director, [Subject Company] From: [Name], Managing Director / Medical Director, [Complainant Company]

Re: [Brand (AAN)] — [material title], [material identifier from the mandatory information], [where and when observed]

1. Material subject to this complaint. [One line per item: title, the unique identifier printed with the mandatory inclusions, the medium, the date first observed. A copy of each is attached as Annexure A.] This letter defines the scope of the intercompany dialogue and of any complaint subsequently submitted to Medicines Australia.

2. Issues raised. [One numbered paragraph per claim. Quote the claim as it appears; state what the Product Information, the cited study or the body of evidence actually says; state why the claim as presented is inaccurate, unbalanced, inconsistent with the PI or misleading — directly, by implication, or by omission.]

3. Provisions alleged to be breached. [For each issue: the Overarching Principle and the Section — for example § OP 8, § 1, § 1.1(b), § 1.2(c), § 2.1(d) — with the requirement in the clause's own words.]

4. References relied on. [The Australian PI as approved on the date the material was observed; each publication cited, attached in full as Annexure B; any correspondence already exchanged.]

5. Outcome sought. [Withdrawal of the material; a corrective communication to its recipients; an undertaking not to repeat the claim in any medium; any other remedy. State which are conditions of resolution.]

6. Process. Under the Standards for Intercompany Dialogue, we look forward to your written response within 10 working days of the next business day after receipt, and propose a meeting within 10 working days of that response. We will treat all communications from this letter forward as part of the intercompany dialogue record.

[Signature] — Managing Director / Medical Director, [Complainant Company]

The signature line is not ceremony. The Standards require the ICD record to be signed by the managing director or medical director of both companies, and Medicines Australia lists "no evidence of Managing Director engagement for both parties" — no signature on the correspondence and no presence at the meeting — among the reasons it may refuse a complaint. Start at that level and stay there.

The clock

The Standards run the dialogue on working days. Public holidays are excluded, and so is the whole of 23 December to 14 January.

The minutes are the artefact. They record the outcome in one of two states. Resolved: the Subject Company accepts a breach and a remedy is agreed; or the Complainant accepts there was none; or the Subject Company does not accept a breach but a remedy is agreed anyway. Unresolved: a breach is accepted but the remedy is not agreed; or the Subject Company maintains there was no breach. If the two companies cannot agree the minutes within 10 working days, each may submit its own record.

Only unresolved matters go to Medicines Australia. Resolved ones must not be included except as identified in the ICD documentation, and the Code Committee will not adjudicate them; where the only thing unresolved is the remedy, the Committee rules on the remedy, not on the breach.

Either side may allege the other did not follow the Standards. The Committee "may, but is not obligated to, request the relevant Company to provide its response to the concern", within ten working days § 15.5(a); both the Complainant and the Subject Company may make the allegation § 15.5(b); the fine is $100,000 § 15.6. Medicines Australia is explicit that its acceptance of a complaint does not assess whether either side made a reasonable effort or whether the scope drifted — those are arguments for the Committee under this section.

At Medicines Australia

The complaint is submitted electronically to the Code Secretariat with an executive summary naming the Principles and Sections alleged; a detailed complaint that identifies each material by its unique identifier, states the practice complained of, cross-references each claim to the evidence and attaches the literature; the ICD record with its outcomes; and the written endorsement of the senior executive officer.

From there the Code sets the pace.

• Acknowledgement "in writing within five (5) working days of receipt" § 15.2(a).
• The Subject Company "shall be given full details of the complaint" and "invited to state within ten (10) working days whether or not the information supporting the complaint is correct, and to give any answer or explanation which may be deemed necessary" § 15.2(b). The Guidelines call this the Subject Company's primary opportunity to present its position: there is no second one unless the outcome is appealed. The response mirrors the complaint — executive summary, itemised responses, original copies of the material, the literature, access to the approved Australian PI, the ICD record or the points of disagreement with it, and the senior executive's endorsement.
• External advice may be taken, under confidentiality and with the adviser given enough to form "a full and proper view" § 15.2(c), § 15.2(d).
• Decisions "within two (2) working days of the Code Committee meeting"; reasons, including "the form of any sanction", within ten § 15.2(f).
• A cease-or-withdraw ruling takes effect at once: the company "shall at once comply with the Code Committee's ruling pending any appeal", and nothing withdrawn "shall be reactivated before the appeal process has been concluded" § 15.2(h).

The Committee that decides is not an industry body. Its chair is "a lawyer with competition and consumer law experience"; its members include three general practitioners nominated by the AMA, the AGPN and the RACGP, a specialist physician from the RACP, a clinical pharmacologist from ASCEPT, a consumer representative — two, where the material was directed at the public — a pharmacist where the material concerns pharmacy practice, and up to five industry representatives, one of them from a non-member company where a non-member is a party § 16.1(a). The Committee meets monthly, and conflicts are declared at the start of each meeting; a party may name competitors it would rather not see on the panel.

A complaint against a non-member is forwarded "with an invitation to have the complaint adjudicated by the Code Committee" § 15.3(a); if the non-member declines, Medicines Australia may forward the complaint and the refusal "to the TGA or the Australian Competition and Consumer Commission (ACCC)" § 15.3(c). Since compliance with the Code is a condition of registration § Scope, declining is not the escape it looks like.

Sanctions

"Sanctions may only be imposed where breaches of the Code of Conduct have been established" § 15.6, and they stack.

Cessation and withdrawal. "Immediate action to discontinue or modify any conduct which is determined to constitute a breach", with written confirmation to Medicines Australia within five working days of the reasons § 15.6.

Corrective action. Retraction statements, corrective letters and corrective advertising, whose "number, format, size, wording, mode of publication, prominence, timing (including duration of publication) and method of distribution" the Committee approves before release. Completed within 30 calendar days of the reasons, evidenced by a copy "signed by the Subject Company Managing Director or Medical Director" § 15.6.

Fines. The schedule:

Fines apply "individually or cumulatively", "up to a maximum of $300,000 per complaint" § 15.6(b). An unactioned sanction draws a further fine of up to $50,000 § 15.6(c), and Medicines Australia may forward the file to the TGA or the ACCC and publicise the failure § 15.6(d).

The schedule is the ceiling, not the practice. On the outcomes Medicines Australia has published for complaints decided from 2023 to 2025, the Committee has imposed one fine per complaint rather than one per breach; moderate was the most common grading; fines have clustered between $60,000 and $200,000 with a median near $130,000; the $250,000 and $300,000 ceilings have not been reached; and every breach finding has carried withdrawal and publication, while corrective letters have become rare. Roughly four complaints a year reach adjudication. Read that as the pattern, not a promise — the schedule is what a Committee can do.

The appeal

Either party may appeal, in writing, "within five (5) working days of receiving the decision(s) and the reasons" § 15.7(e); the written submission follows within a further five, and the other side responds within ten § 15.7(f). An industry appellant lodges a $20,000 bond § 15.7(h); a non-industry complainant does not § 15.7(j).

An appeal "is a rehearing of the part of the original complaint that is the subject of the appeal", and the Appeals Committee "shall not uphold an appeal unless it is persuaded that the findings of the Code Committee, or the sanction imposed by it, involved an error" § 15.7(a). It decides on the record before the Code Committee, may admit fresh evidence, but judges "the circumstances that existed at the time the conduct or activity occurred" — for a claim, "only … what substantiating clinical evidence was published and available at the time" § 15.7(b). Both sides may present orally § 15.7(c); an external expert "shall not act as an advocate" § 15.7(d). Decision within two working days, reasons within ten § 15.7(l); the outcome is published within a month.

The monitor

There is a third way a piece reaches the Committee, and it needs no complainant. The Monitoring Committee "will proactively monitor conduct of Companies on a regular and ongoing basis", reviewing "activities that are less likely to receive public or another Company's scrutiny" § 15.8 — healthcare-professional-restricted websites, promotional materials, representative-training policies and the procedures that govern interactions with healthcare professionals and other stakeholders § 15.8(c). Companies "will be required to submit … an electronic copy of materials that were in use during a specified period" § 15.8(a), on no more than two occasions in a calendar year § 15.8(d). A possible breach goes back to the company for explanation § 15.8(e), and if the explanation does not satisfy, "refer the matter to the Code Committee as a complaint" § 15.8(f).

The practical consequence: every piece in market is a piece that may be asked for, and the review file behind it — the PI it was held to, the references, the sign-off — is the response.

The SOP, in one page

None of what follows is the Code; the Code sets the standard and the Standards set the clock. This is how an affiliate makes both operable, and it is the frame we'd write a complaints SOP around today.

Roles. One owner of the clock (usually Regulatory Affairs or Compliance); one holder of the record; the Managing Director or Medical Director as signatory on every formal letter and present at the meeting. Delegation of the Managing Director's role must be documented if it is to survive Medicines Australia's acceptance check.

On receiving a Formal Written Complaint. Log the date received and calendar the next business day as day one. Diary the 10-, 20-, 30- and 35-working-day marks, skipping public holidays and 23 December to 14 January. Pull the material by its identifier, the PI as approved on the date the material was in use, and the references — the response will need originals and the literature attached. Decide within the first week whether to resolve or defend; a resolution agreed in dialogue never reaches a published outcome.

On sending one. Informal contact first, medical director to medical director. If it fails, the letter above — scoped to everything at once, at signatory level, with the annexures. Hold the other side to the clock and escalate at the two-working-day point rather than letting a meeting drift. Write the minutes the day of the meeting. Submit within 15 working days of their agreement, or lose the right.

Building the case. A complaint and a response are the same document from opposite ends: claim by claim, against the PI, the evidence and the clause. That is the shape the Contender produces — it reads a competitor's material the way a Code Committee will, tests each claim against the Australian PI and the substantiation rules, and writes the exposure as material, issue, clause and reference, which is the letter's sections 1 to 4. Fair competition is the workflow around it, and the same read of your own material before it ships is the cheapest complaint you will ever handle.

Afterwards. File the ICD record, the complaint, the response, the decision and the reasons together, whatever the outcome; a "repeat of previous breach" is priced at $250,000 § 15.6, and the only defence against being found to have repeated one is knowing what was found.