21 January 2020
With increased enforcement action by regulators including in relation to medicines advertising to healthcare professionals alleged to be misleading, we look at the guidance available from the decided cases in the courts. We consider the relevance of that guidance to recent infringement notices by the Therapeutic Goods Administration in relation to opioid advertising to doctors.
Regulators, including life sciences regulators, are under pressure, since the Hayne Financial Services Royal Commission, to be more active in enforcement. In the pharmaceutical industry, the Therapeutic Goods Administration (TGA) took enforcement action in 2019 in relation to advertising of peptides and secured a $10 million penalty from the Federal Court (the defendant was under insolvency administration and took no part in the proceedings). 
In December 2019, the TGA issued infringement notices to the sponsor of Targin, an opioid, imposing fines in relation to advertising to doctors. The pharmaceutical company respectfully disagreed with the TGA that the advertisement was misleading, inaccurate or unsubstantiated but paid the fines.
It seems likely that there will be more enforcement action of a similar kind from the TGA alleging that advertising to general medical practitioners, specialist doctors or other healthcare professionals is misleading, whether that be on the basis of the Australian Consumer Law prohibitions on false, misleading or deceptive conduct by corporations in trade or commerce, or by reference to an industry Code of Conduct compliance with which is a condition of product registration.  Industry codes include much detail and use language including false, inaccurate and unsubstantiated. In substance, in the advertising context, there may be little if any difference from the concept of misleading or deceptive.
It is instructive, therefore, to look to the decided case guidance from the courts in relation to the application of the misleading conduct prohibition in the context of drug (or related medical product) advertising to healthcare professionals. We leave aside industry body decisions which are not decided by courts (or lawyers). Ultimately, the TGA applies the law, as explained in the decided cases in the courts, in its enforcement action in relation to doctor advertising alleged to be misleading.
There have been few cases about alleged misleading advertising to doctors, as opposed to consumers, and even fewer that proceeded to a concluded published judgement. In 1999, Bristol Myer Squibb, the supplier of the market leading (in its class) anti‑hypertensive Irbesartan, sued (then) Astra Pharmaceuticals in relation to its launch campaign for Candesartan (Atacand).  An urgent preliminary injunction was sought and ruled on with a mixed outcome, in the Federal Court but the matter appears then to have settled. In the early 2000s, Janssen Cilag took action against Amgen over ‘Dear Doctor’ letters concerning reported serious side effects associated with Janssen’s erythropoietin. The litigation settled without a final trial.
At around the same time, CSL sued GSK in relation to pre-launch information concerning GSK’s HPV vaccine to compete with CSL’s market leading vaccine Gardasil. CSL sought urgent preliminary relief but this was refused because an early final hearing was imminent and the matter appears then to have settled. In 2008, in the context of a patent case, Apotex alleged that Servier’s claims to doctors about its new formulation for an anti-hypertensive medication were misleading, with the case largely unsuccessful.
The most instructive decisions are AstraZeneca v GSK in relation to general practitioner asthma medication advertising and Novartis v Bayer, a case about macular degeneration injection therapy marketing to ophthalmologists, because they are considered final (and appeal) judgements on evidence with detailed written reasons.
In 2005, AstraZeneca sued GlaxoSmithKline alleging that GSK’s promotional campaign for Seretide, following publication of a significant clinical study into patient control of asthma symptoms, was misleading. In a case that was heard at trial and on appeal to the Full Court, AstraZeneca was wholly unsuccessful.
GSK’s Seretide advertisements included text such as “imagine if you had the power to totally control asthma…”, “now you can achieve that goal with SERETIDE TOTAL CONTROL” and “symptomatic patients – looking for control? Switch to Seretide”. The claims were footnoted to detailed references to the relevant clinical study and the prescribing information. The target audience was general practitioners.
The argument by AstraZeneca was that, in each of the Seretide advertisements, misleading representations were conveyed to the effect that all or virtually all asthma patients will achieve 100% control or total control of all asthma symptoms by using Seretide (and a range of alternative graded representations).
The trial judge doubted that general practitioners relied on information/representations in advertisements of the kind in question in magazines (typical monthly practitioner publications). There was evidence introduced by GSK that general practitioners place no reliance on such advertisements in prescribing medications for their patients with symptoms of asthma; and they would regard such advertisements as part of marketing campaigns undertaken by drug companies to promote their products, and not as a source of information by reference to which they prescribe medications.
Rather, the evidence indicated that general practitioners relied on their own familiarity with and experience in the form of patient acceptance and results achieved in prescribing the medication which was the dominant asthma medication at the time and extensively prescribed. The trial judge found that no representations were conveyed as alleged by AstraZeneca and that, if they were, they were counterbalanced by messages about the clinical study, or in any event qualified by the footnotes.
The Full Court agreed with the trial judge and viewed the advertisements as marketing documents not sources of information for doctors on prescribing. The phrase Seretide Total Control was a brand slogan not a claim. Likewise, the Full Court found that none of the alleged misleading representations was in fact made, having regard to the nature of the audience to whom they were directed, the qualifying footnotes and the familiarity of doctors with the medication.
In 2015, Novartis took legal action against Bayer, with both companies competing in relation to age-related macular degeneration therapy administered by intra-vitreal injection. Novartis alleged that Bayer’s materials directed to ophthalmologists, published at conferences and in doctor magazines at educational meetings, involved misleading product comparisons. The Federal Court rejected Novartis’ case.
This case focussed on alleged representations that, in accordance with approved dosages, all patients for the Bayer product receive fewer injections than patients of the Novartis product. The Bayer material was included in posters at conferences of specialist ophthalmologists and in detailers and orally in discussions between representatives and doctors.
The Court considered the relevant audience to be ophthalmologists and that the role of optometrists was not significant in determining what representations were conveyed by the material. Ophthalmologists were highly trained and knowledgeable specialist doctors making a serious decision as to patient treatment and taking into account factors such as the information from the available medical literature, discussions with peers, patient experience, the particular patient’s pathology and progress, combined into an individualised recommendation for a patient treatment plan which would be revisited from time to time.
The Bayer poster headline wording was “Eylea for you and your patients with fewer injections when used according to the approved dosage compared to monthly Lucentis”. The Court did not accept that this conveyed the claimed messages as to the invariable results for all patients. While accepting the principles enunciated in the cases for the assessment of whether advertising is misleading, including by the High Court in the TPG Internet case, the cases depended on the their facts and circumstances. In Novartis v Bayer, the class of addressee was entirely different and the material different from the consumer telco advertisements before the High Court. The audience here was specialist doctors not consumers. The material did not contain a single dominant message given its form and meaning.
While accepting that ophthalmologists are not immune from the effects of advertising, they will understand and be affected by advertisements in the light of their training, knowledge and experience. The Court did not accept that a reasonable ophthalmologist would stop at the words ‘fewer injections’. The words used did not mean that in clinical use Lucentis was administered monthly for all patients, and ophthalmologists would not take from the words in context the alleged misleading representation. Ophthalmologists would not read the words used as misstating the effect of the product information nor to deny professional judgment and the inherent variability of patients and their conditions.
In the cases discussed, the courts treat the context of doctor advertising as special and different from consumer advertising. Doctors, general practitioners and specialists, are not easily misled by advertising and marketing. Because of their training and knowledge, and their role in undertaking decisions about patient treatment, they will take account of a range of information including their own experience, a range of medical and other information, detail in footnotes and prescribing information.
The full context of the communications with health professionals the subject of the TGA infringement notices is not available as they have been withdrawn. In its press release, the statement called out by the TGA is: “Opioids should be used as part of multimodal pain management plan and in an ongoing trial, as they are associated with potential harms, including unsanctioned use, addiction and overdose”.
The TGA press release makes a number of statements about its concerns about the overall effect of the statement as positively encouraging the prescription of the product for chronic non-cancer pain; that opioids should not be represented as a core component of management of such pain, and the decision to prescribe opioids should be approached with significant caution.
When considered, however, in light of the approach taken in the cases discussed, it does not appear clear that the courts would have reached a conclusion that the communication to doctors was misleading.
As we have seen, the issue of advertising to healthcare professionals and when it is misleading is an important issue for the pharmaceutical and life sciences industries. Increased enforcement activity by the TGA may result in matters less often being determined at the industry Code of Conduct level. A key issue raised in the cases concerns context and how promotional/informational material directed to healthcare professionals is understood by them. The guidance from the decided cases appears to suggest that healthcare professionals are not easily misled, given their level of education and the seriousness of the patient care exercise they undertake when selecting a medication or therapy to prescribe. As regulatory enforcement action increases there may need to be further consideration of that guidance.
 Secretary, Department of Health v Peptide Clinics Australia Pty Ltd  FCA 1107 (23 July 2019).
 TGA Press release 20 December 2019 – link.
 Mundipharma Press release 20 December 2019 – link.
 For example, section 18 ACL.
 For example, Medicines Australia Code of Conduct Edition 18 section 1.3 states that: All information, claims and graphical representations provided to healthcare professionals or members of the general public must be current, accurate, balanced and must not mislead either directly, by implication, or by omission.
 Bristol-Myers Squibb Australia Pty Ltd v Astra Pharmaceuticals Pty Ltd  FCA 256.
 CSL Ltd v GlaxoSmithKline Australia Pty Ltd  FCA 1301.
 Apotex Pty Ltd (formerly GenRx Pty Ltd) v Les Laboratoires Servier (No 2)  FCA 607.
 AstraZeneca Pty Ltd v GlaxoSmithKline Australia Pty Ltd  FCA 1645.
AstraZeneca Pty Ltd v GlaxoSmithKline Australia Pty Ltd  FCAFC 22.
 Novartis Pharmaceuticals Australia Pty Limited v Bayer Australia Limited 2015 FCA 35.
 Australian Competition and Consumer Commission v TPG Internet Pty Ltd  HCA 54.
The content of this publication is for reference purposes only. It is current at the date of publication. This content does not constitute legal advice and should not be relied upon as such. Legal advice about your specific circumstances should always be obtained before taking any action based on this publication.