The speaker briefing — the letter § 4.1(c) asks for, drafted.

Of the three things § 4.1 requires of a company-run educational event — the agenda, the internal approval, the speaker briefing — the third is the one most often missing from the file, and the one a Monitoring Committee request or a complaint response will ask for by name. This is the clause, who it reaches, and a letter that meets it.

What the clause asks

"Companies should ensure that healthcare professionals speaking at Company-sponsored educational events or Congresses are aware of the obligation not to promote unapproved products or indications. This applies irrespective of whether the Company has provided the healthcare professional with a presentation or other material. Companies should be able to produce documentary evidence of this briefing and its content, which can be publicly disclosed if required" § 4.1(c).

Four obligations in three sentences. The speaker is made aware — told, not assumed to know. It applies to a speaker using their own slides as much as one using the company's. The briefing is documented, with its content. And the document is written to be disclosed — a Committee may read it, and so may a journalist.

The exemption is narrow: the briefing "does not apply to independent third-party educational events or Company-sponsored educational events where an independent scientific faculty has chosen the topics and speakers" § 4.1(c). If the company chose the speaker, or the topic, it owes the briefing — a satellite symposium at a congress included.

What "unapproved" means for a speaker

The obligation the speaker is briefed on is the one in § OP 8: promotional claims "consistent with the Australian Product Information document … irrespective of the source on which the claim is based". For a speaker that has three practical edges.

Australian. An international speaker's deck is written to their own market's label. The indication, the population, the dose in the slides are consistent with that label and may not be with the Australian PI. A speaker briefed only on "don't go off-label" will not know that a use approved at home is unapproved here.

Wider than a disease name. Off-label is any claim not consistent with the PI as a whole — indication, population, directions, dose, endpoints and safety. A trial in a broader population than the PI's, a loading dose the PI did not adopt, an outcome the PI does not carry: each is unapproved from a company platform even when the disease is right. The off-label guide has the five tests.

The question from the floor. A speaker will be asked about the unapproved use. The answer is not a claim from the stage; it is a referral. Scientific exchange on unregistered products and off-label topics belongs to the Medical Department, under the Medical Director or delegate, with the material clearly identified as off-label and approved § 7(c), § 7(d), § 7(e). A company speaker at a promotional event is not that channel. The Tool Kit's Virtual Meetings Guidance says the same of online events: unapproved products and indications cannot be promoted, and the educational opportunity can be shared through scientific exchange instead.

The letter

The Code fixes the obligation and the evidence, not the form. This is the shape we use — short enough that a busy clinician reads it, specific enough that it can be produced.

Speaker briefing — [Event title], [date], [venue or platform]

[Date]

Dear [Dr / Professor name],

Thank you for agreeing to speak on [topic] at [event], a [Company] educational event held under the Medicines Australia Code of Conduct. Under the Code we are required to brief every speaker at our events on the obligation below, and to keep a record of having done so. This letter is that briefing and that record.

1. The obligation. Nothing presented from the platform may promote an unapproved product or an unapproved use of a registered product. The reference is the Australian Product Information for [brand (AAN)], enclosed as it stands on [date]; the indications registered in Australia are: [indications, with their populations and qualifiers as the PI states them]. Consistency with the PI covers the indication, the patient population, the limitations and directions for use, the dose and regimen, and the endpoints and safety data — not only the disease named. This applies whether the slides are ours or your own.

2. What falls outside it. [Where relevant, name them: a use approved in other markets but not in Australia; the [trial] population beyond the PI's; the [dose/regimen] not adopted in the Australian PI; [outcome] not carried in the PI.] These may be discussed only by [Company]'s Medical Department, not from this platform.

3. Questions from the audience. Where a question concerns an unregistered product or an unapproved use, please refer it to [name], [Medical Advisor / Medical Director], who will be present and may respond in accordance with the Code's provisions for scientific exchange.

4. Your presentation. [Where the company has seen the deck:] We have reviewed your slides against the Australian PI and note [no changes / the changes at Annexure A]. [Where it has not:] Please send your slides to [name] by [date] so that we may review them against the Australian PI before the event. Any claim in the presentation must be substantiated and referenced, and comparative statements must meet the Code's requirements on statistical significance and balance.

5. Disclosure. Please state at the start of your presentation that you are speaking at the invitation of [Company] and disclose any relevant interests. The transfer of value for this engagement will be reported under Section 14 of the Code, as set out in your agreement.

This letter is kept on the event file and may be disclosed if Medicines Australia requires it. Please confirm by reply that you have read it.

[Name], [Medical Director / Medical Advisor], [Company] · [City]

The signature belongs with Medical, because the letter is a medical judgement about the PI, and because Medical is the channel for the questions it routes. Enclose the PI; a briefing that says "consistent with the PI" and does not put the PI in the speaker's hands has told them the rule without the reference.

The file

Keep the letter, the speaker's confirmation, the enclosed PI as of that date, and the reviewed deck together with the agenda § 4.1(a) and the internal approval § 4.1(b). If the speaker did depart from the briefing on the night, the file is what shows the company did what the Code asks; the Help Desk's recent guidance on third-party content adds that when an issue surfaces during an event, a quiet check-in or a change of branding may be proportionate, and that a recording amplifies whatever was said — correction or removal afterwards may be reasonable.

A briefing that exists only as "we always tell them" is the one that cannot be produced.