The Overarching Principles — ten sentences, and how to write to them.

Most of what is written about the Code is written for the reviewer — the checklist, the mandatory inclusions, the clause to cite when a piece fails. This is written for the person before the reviewer: the medical writer, the brand manager with a blank page, the agency. Edition 20 opens with ten Overarching Principles, and its own instruction is that they "govern all activities covered by this Code". Every Section after them is one Principle carried onto a page. A piece written to the ten is a piece the reviewers pass; a piece written to the Sections alone is one they correct. Here are the ten, in the Code's words, with what each asks of the writer, the Sections that make it concrete, and — at the end — a working order for composing a piece in the Principles' own sequence.

What the Principles are

Part A. The Code introduces them as "ten Overarching Principles that govern all activities covered by this Code, as well as more detailed provisions to support these activities" § Interpreting this Code, and Part A's own preamble makes them an obligation, not a preface: "Companies must ensure that these Overarching Principles are reflected in all activities covered by this Code" § Part A. They have no sub-structure — § OP 8 is the whole of the eighth — and the Tool Kit's Overarching Principles one-pager reproduces them without commentary, because they need none.

Two consequences for a writer. The Principles are what makes the Code "systems neutral": the Sections were written with print and digital in mind, the Principles were written for any medium, so a format the Sections do not mention is still governed. And a complaint rarely finds a breach of a Section alone — the Promotional Claims Guidance notes that many complaints in which material is found misleading have also found a breach of § OP 1, because a misleading piece has failed the purpose the Principle sets. A piece is held to a Section and to the Principle behind it; the writer who works from the Principle has met both.

1. Purpose

"All activities undertaken by Companies have the purpose of supporting the quality use of medicines" § OP 1.

The Glossary defines quality use of medicines as "selecting management options wisely; choosing suitable medicines if a medicine is considered necessary; and using medicines safely and effectively" § Glossary. That is the test of the whole piece before any sentence in it: does it help a prescriber choose this medicine when it is the right one, and use it well? A piece that only creates awareness is not enough — § OP 7 says promotional materials "are designed by Companies to not only create awareness of Therapeutic Goods Administration (TGA) approved medicines, but to support proper assessment of their risks and benefits".

For the writer. Decide, in one sentence, what a prescriber will do better after reading this. If the sentence is "prescribe more", the piece has no purpose the Code recognises, and a reviewer will find that under § OP 1 alongside whatever Section the copy fails. If the sentence names a clinical decision the piece supports, the rest of the piece has a spine.

2. Transparency

"Companies are committed to transparency in their interactions with healthcare professionals and other stakeholders, to maintain trust and confidence in the industry" § OP 2.

On the page this is the Section 2 rule that "promotional material must be clearly distinguishable as such" § 2(b). The Glossary defines an advertorial as "content that looks like editorial content but is published under a commercial arrangement" § Glossary, and the Code allows companies to engage the professional media "including issuing media releases and developing advertorial content" § 2(f) — as long as it is recognisable for what it is. Where a company's involvement in third-party content goes beyond paying for it — choosing the expert, identifying the studies, holding editorial control — the Help Desk's position is that the company owns the content's compliance, mandatory inclusions included. And where a company site links out, the reader is told, in words the Code prescribes: "The information a reader is about to be referred to may not comply with the Australian regulatory requirements. Further information relevant to the Australian environment is available from the Company or via the Product Information" § 2.2(c).

For the writer. Say what the piece is. Promotion that reads as education, a sponsored feature that reads as journalism, a "medical update" that carries the campaign line — each is a transparency failure before it is anything else.

3. Information

"As the primary repository of information relating to their products, Companies are responsible for providing current, accurate, balanced, and scientifically valid information on products to support their appropriate use. The same standards apply to all other Company communications" § OP 3.

This is the Principle that Section 1 operationalises, and it is where most of a writer's craft goes. Every claim is referenced, and the reference provides "the appropriate level of evidence for the claim being made", reflects "the body of evidence", and lets the reader "independently evaluate the validity of the results" § 1(a). The data behind it is "easily retrievable so that they can be supplied on request within 10 working days" § 1(i).

The substantiation rules in § 1.2 are the writer's rules of evidence. Posters, abstracts, personal communications and unpublished data are not sole substantiation § 1.2(a); data on file may support a claim about prescribing frequency or patient exposure but "would not be appropriate as sole substantiation for a safety or an efficacy claim" § 1.2(b). The evidence must be "consistent with the body of evidence" § 1.2(c), and "selective use of consistent positive results while neglecting consistent negative results from a systematic review or meta-analysis is not appropriate" § 1.2(d). A secondary endpoint where the primary was missed may be used only if it is consistent with the body of evidence, reflects the study's conclusion, and "it is clear to a reader that the primary endpoint was not met" § 1.2(e); a post-hoc analysis must be "clearly identified as post-hoc, used in context of the primary endpoint(s) and appropriately qualified" § 1.2(g); animal or laboratory data need a qualifying statement that "such data do not necessarily predict clinical effects" § 1.2(i).

The Promotional Claims Guidance adds the hierarchy: use the highest level of evidence available — systematic reviews of randomised trials, then randomised trials, then meta-analyses, with network meta-analyses and indirect comparisons "generally insufficient on their own for strong comparative claims", real-world evidence acceptable when it is the highest available and identified as such, and conference presentations treated as abstracts.

Current is the word writers forget. The Help Desk's indicative timeframes for correcting material after a change — around three months for prescribing information, longer for an address — are suggestions, but the obligation behind them is § OP 3, and a piece that quotes a superseded PI is inaccurate from the day the new one is approved.

For the writer. Every sentence with a number has a source at the highest level that exists, drawn from the whole evidence rather than the flattering half, and the source is in the file before the sentence is in the draft.

4. Training

"Company employees, and anyone acting on behalf of a Company, will be appropriately trained on the Code and maintain a high standard of ethical conduct and professionalism in the discharge of their duties" § OP 4.

Anyone acting on behalf reaches the agency. Section 9 makes it specific: "any person who is directly involved in the development, review and approval of promotional materials … must complete the Code of Conduct component of an endorsed Medicines Australia education program within the first 12 months of commencement of employment" § 9(b), and the requirement "applies equally to permanent employees or contracted employees" § 9(c).

For the writer. If you write promotional material for an Australian company, the Code expects you to have done the Code component of the Continuing Education Program within your first year. It is the difference between a writer who knows why the qualifying statement goes under the claim and one who moves it to the footer for the layout.

5. Influence

"Consistent with our ethical undertakings, nothing is offered or provided by a Company in a manner or with conditions that would have an inappropriate influence on the approval, recommendation, prescribing, and/or use of a product" § OP 5.

A writer meets this Principle in what a piece offers. Companies "do not offer items or gifts, which may inappropriately influence prescribing a product" § 3(b); what is appropriate is company-branded items "of low monetary value, relevant to the conduct of the educational meeting" and company-branded educational material § 3(b). Market research "should not be implemented as competitions or quizzes" § 8(d). The Tool Kit's gifts guidance puts most of the traditional leave-behind cupboard — calendars, stationery, cups, lanyards — on the prohibited list regardless of value, and company-run competitions may offer no prizes.

For the writer. The piece offers information and nothing else. A detail aid that ends with a voucher, a survey that ends with a draw, a "patient resource" that is really a branded object — each is § OP 5 before it is § 3.

6. Audience

"Companies' interactions with all stakeholders are at all times professional, consistent with all legislative requirements, and appropriate to the information needs of the respective audience" § OP 6.

Who the piece is for decides which Part of the Code governs it. Material for healthcare professionals must be "only able to be viewed or accessed by healthcare professionals" § 2(a), with password protection or its equivalent for anything online carrying claims § 2.2(a). For the public, prescription medicines cannot be promoted at all — the Therapeutic Goods Act's prohibition, which the Code refers to rather than restates § 2.3(a) — and disease-awareness material "may include descriptions of the therapeutic category including classes but does not include any reference to a specific prescription product" § 12.2(a), must be "comprehensive, balanced and fair" § 12.2(b), keeps its emphasis "on the condition and its recognition rather than on the treatment options" § 12.2(c), and "must not be presented in a way that unnecessarily causes alarm" § 12.2(d). A patient already prescribed the product may receive product-specific programs and aids, which "must not be promotional" § 12(d).

For the writer. One audience per piece, named before the first line. A piece that tries to serve the specialist and the patient serves neither and breaches for both.

7. Prescribing information

"Information relevant to prescribing, in particular product and safety information, are clearly communicated in all promotional materials. Promotional materials are designed by Companies to not only create awareness of Therapeutic Goods Administration (TGA) approved medicines, but to support proper assessment of their risks and benefits" § OP 7.

Three Sections carry this onto the page. The inclusions: "all promotional material for a product, whether or not the material contains a promotional claim", carries the brand name, the Australian Approved Name beside the most prominent brand mark, any boxed warning or black triangle the TGA requires, a statement directing the reader to the PI with the means to reach it immediately, the funding status, the supplier's name and locality, and the date § 2.1(a)–§ 2.1(g). The qualifiers: "linked to the relevant claim with a readily identifiable symbol and appear directly below or adjacent to the claim. Qualifying statements must be prominent" § 1(b), and PI qualifying statements and references "clearly legible" § 2(d). And balance: "proportionate weight to the benefits and risks of a product", recognising "that product and risk information are as relevant as any therapeutic, promotional, or non-promotional claim" § 1.1(b), with the presentation of risk "appropriate to the complexity of the promotional material, the therapy area, stage of product lifecycle" § 1.1(c).

The Tool Kit's Balance Guidance turns the last of those into a working scale: a complex piece — an e-detailer, a website, a multi-page leave-behind — carries safety information specific to its claims, embedded beside the benefits; a simple one — a banner, a single panel — may carry less and link to the PI; a brand-only piece carries the inclusions and nothing more, though a boxed warning or black triangle is required whatever the format § 2.1(c). Two things do not count as balance: the mandatory inclusions, and a QR code — the Prescribing Information Guidance is explicit that a link to the PI does not substitute for balance in the piece itself.

For the writer. The risk sits beside the benefit, in the same size, on the same view — not behind a link, not at the foot of the page. And the piece is designed to be read "in isolation" § 2(e): the panel a reader sees alone must be accurate alone.

8. The Product Information

"All promotional claims are consistent with the Australian Product Information document, including claims about competitor products, irrespective of the source on which the claim is based" § OP 8.

Section 1 restates it as the operating condition for all promotion — "current, accurate, balanced, consistent with the approved product information, and do not mislead directly, by implication, or by omission" § 1 — and the Promotional Claims Guidance gives the five tests of consistency: indication, patient population, limitations and directions, dose and regimen, endpoints and safety. The off-label guide works through them. The Guidance's own list of claims inconsistent with the PI is a writer's list of things not to draft: an indication shortened so that a qualification disappears; a population the PI does not cover; a dose or frequency the PI does not give; an adverse-event rate lower than the PI's; an outcome the PI does not carry; monotherapy where the PI requires combination; a claim supported by an overseas PI where the Australian one differs.

The competitor half of the Principle has its own rules. "The statistical significance of comparative claims must be clearly indicated" § 1(e); a non-significant result carries the words "not statistically significant" in full § 1.2(k); "'hanging' comparative claims should not be used" — "better, stronger, or more widely prescribed" with no comparator § 1(h); superlatives are used only where "substantiated by the appropriate level of evidence" § 1(f). And the Guidance warns that tables or graphs from different studies placed side by side imply a head-to-head comparison that may not exist.

For the writer. Write from the Australian PI, open beside the draft, for the strength and presentation the piece promotes. When the paper says more than the PI, the PI wins; when the global master says more than the PI, the PI wins.

9. Events

"All events, initiated or sponsored by Companies, are reasonable and appropriate with respect to hospitality, travel and accommodation, therefore upholding the integrity and reputation of the industry" § OP 9.

The writer's part of an event is the invitation, and the Code makes it evidence: the company "should be able to produce objective evidence of the educational value of the event (for example, an invitation or agenda) that clearly describes the purpose, content, meeting start and finish times and duration of educational sessions" § 4.1(a). An invitation is also promotional material if it names the product, and carries the inclusions. What it does not carry is the dinner as the draw — hospitality "is secondary to the purpose of an activity" § 4.5(b), and the venue is chosen for the education, not "for the purpose of leisure, sporting or recreational activities" § 4.5(a). The events and hospitality guide has the rest.

For the writer. The invitation describes the education — who is speaking, on what, from when to when — and mentions the meal, if at all, as what it is.

10. Identification

"All activities undertaken by Companies are clearly identified to their audience as a Company activity by the inclusion of the Company's name and city/town of the Company's Australian office" § OP 10.

The simplest Principle and the one most often lost in a template: "name of the supplier and the city, town or locality of the registered office" § 2.1(f), and the "date that the material was prepared or last revised" § 2.1(g). The Help Desk's line on the other side is useful too — a brand name alone, in a subject line or on a business card, is not promotion and does not trigger the inclusions; add any information about the product and it is.

For the writer. Sign it, place it, date it. The date is not housekeeping — it is what tells a reader, and a reviewer, which PI the piece was written to.

Composing in the Principles' order

None of what follows is the Code; the Code sets the standard, and the order is ours. But a piece composed in this sequence is written to the Principles rather than repaired against the Sections, and the review that follows is a confirmation rather than a rewrite.

1. Name the audience § OP 6 — professionals or the public, and which professionals. It decides every rule that follows.
2. Open the Australian PI § OP 8 — the current one, for the presentation being promoted — and keep it open. Not the global master, not the paper.
3. Write the purpose sentence § OP 1 — the clinical decision the piece helps a prescriber make. If it cannot be written, stop.
4. Draft the claims from the evidence, not toward it § OP 3, § 1(a), § 1.2 — each claim from the highest evidence available, consistent with the body of it, with its reference beside it in the draft and its source in the file.
5. Run the five tests on every claim § OP 8 — indication, population, directions, dose, outcomes — and on the positioning of the piece as a whole, imagery included.
6. Put the risk beside the benefit § OP 7, § 1.1 — proportionate to the piece's complexity, in the same view, and the qualifying statements under the claims they qualify § 1(b).
7. Lay in the inclusions § 2.1 — all seven, whether or not the piece makes a claim.
8. Check what the piece offers § OP 5 — information only.
9. Say what it is § OP 2 — promotion, distinguishable as promotion; and gate it to its audience § 2(a).
10. Sign, place and date it § OP 10, § 2.1(f), § 2.1(g).

Then the checks, in the same order the piece was built: Reviewer reads it as your medical, regulatory and compliance reviewers will — positioning against the PI first, then the claims, the balance, the inclusions — and Register holds each claim to the reference it cites. Faster approvals is what review looks like when the piece arrives already written to the ten.