2015 cases

Précis of Committee meetings held in 2015

Case 289/04/15: Complaint by Zoetis UK against MSD Animal Health regarding Nobivac

This Case related to MSD Animal Health’s information, supplied to veterinary practices in February 2015, concerning a leptospirosis outbreak and MSD Animal Health’s Nobivac product. A second communication which was stated to be a correction of the first was held to be promotional and also in breach of the Code.

1. That in the context of an email circulated to four veterinary practices in February 2015, which the Committee confirmed was clearly promotion within the meaning of Clause 1.1 of the Code:-

A. The words: “Unfortunately the practice in Bristol that has had the most cases confirmed (Highcroft) were using the Vanguard range and these dogs were not protected and many of them despite being up to date with vaccinations, sadly died…….(Highcroft) were using the Vanguard range” were conceded to be in breach of the Code by the Respondent and were confirmed by the Committee to be in breach of Clauses 4.1(i) in not being fair, 4.1(iii) in being misleading; 4.1(iv) disparaged the products of another company; 4.2(i) in being inaccurate and 4.1(ii) in not being based on up to date evaluation of all the evidence.

B. The words: “… and these dogs were not protected and many of them despite being up to date with vaccinations, sadly died” were conceded to be in breach of the Code by the Respondent and was confirmed by the Committee to be in breach of Clauses 4.2(i) in being inaccurate; 4.2(ii) in not being based on an up to date evaluation of all the evidence, and 4.2(iii) not being capable of substantiation.

C. The words “…old bivalent vaccines….” was not conceded by the Respondent to be in breach of the Code and which the Committee adjudicated was not in breach in that use of the term ‘old’ in this context did not imply any inferiority.

D. The words: “…..from MSD if you want to offer your patients improved protection” and

E. The words: “…moved to Nobivac vaccines to ensure a better protection against circulating disease”, neither of which being conceded by the Respondent as being in breach of the Code, were adjudged by the Committee to be in breach of the Code. The Committee decided it was appropriate to consider these two sets of words together, as they clearly correlated together in the message that was given to the reader, namely, that changing from the Vanguard vaccine to the Nobivac range of vaccines (specifically Nobivac L4) would provide greater protection to dogs from contracting Leptospirosis. Whilst the Committee accepted (and such was common ground) that tetravalent vaccines theoretically did give broader protection as they protected against four different serovars as opposed to two serovars than bivalent vaccines, the absence of any body of clinical data that such Nobivac vaccines than Vanguard vaccines gave rise to better protection against Leptospirosis in the United Kingdom meant that the words were in breach of Clauses 4.2(iii) not be capable of substantiation in the case of item D; and 4.1(i) in being unfair; 4.1(iv) in disparaging the products of another company; 4.1(vii) in stating or implying that Nobivac vaccines have a special merit, quality of property which could not be substantiated; 4.2(i) in being inaccurate and 4.2(iii) in not being capable of substantiation in the case of item E.

F. The words “the number of confirmed leptospirosis Bratislava cases in Bristol postcodes alone since December has now reached over 30 and there are also numerous further cases confirmed in South Wales, Shepton Mallet and Weston Super Mare” were conceded by the Respondent and were confirmed by the Committed to be in breach of Clauses 4.2(i) in being inaccurate; 4.2(ii) in not being based on up-to-date evaluation of all the evidence and 4.2(iii) in not being capable of substantiation.

2. That in the context of a subsequent email circulated by the Respondent on or about 25 March 2015 to those practices, which was maintained by the Respondent both to the Complainant and to the Committee at the meeting to be a rectification of and apology for the earlier message, the Committee had no hesitation in deciding that the words to which complaint was made were clearly promotion within the meaning of Clause 1.1 of the Code. In relation to:-

A. The words “at least 10 have positive MAT serological tests that may be consistent with exposure to infection from serovar Bratislava” were not conceded to be in breach of the Code, a view with which the Committee agreed. It was considered that the overall phraseology emphasised the uncertainty, by the words used both before and after the words which were the subject of the complaint, viz: the word “may” and the caveats: “number of pitfalls”, referable to MAT testing; reference to “premature testing”; and the fact that further analysis was being undertaken to further understanding of the nature of the outbreak.

B. Conversely, in considering the words “no cases were seen in dogs that had completed a primary course with the new tetravalent leptospirosis vaccine”, the Committee found that, contrary to the Respondent’s arguments, in the context used and taking into account the other words in the paragraph, any reader would take such words as implying that a tetravalent vaccine such as Nobivac L4 would have efficacy over older bivalent vaccines such as Vanguard when in reality the only claim that could be made was that tetravalent vaccines protected against more serovars than bivalent vaccines. Whilst the Committee accepted that the words were literally correct, it failed to make it clear how many dogs (if any) had actually been injected with the new tetravalent vaccine during the outbreak and indeed the Highcroft Blog suggested that the Nobivac vaccine was only first used following the outbreak and that immunity would have taken sometime (bearing in mind the SPC that requires two vaccinations with an interval of 4 weeks and 3 weeks for onset of immunity). There was no evidence that a statistically significant number of dogs had been injected with a tetravalent vaccine prior to the outbreak such that a meaningful comparison of the clinical efficacy of bivalent and tetravalent vaccines in protecting dogs against the Leptospirosis outbreak that occurred in the West of England.

Accordingly the Committee found such words, within the context used, to be contrary to clauses 4.2(i), being implicitly inaccurate and 4.2 (iii) being incapable of substantiation.

The wording of the Undertaking:

Case No. 289/04/15

  1. We acknowledge the decision(s) of the Committee in Case 289/04/15 as set out in your letter of 16 June 2015.
  2. To be completed in all cases We accept the decision(s) of the Committee and undertake not to state or imply that:
    1. Nobivac or that any tetravalent leptospirosis vaccine has any superior efficacy over Vanguard or any bivalent vaccines other than that they protect against a broader range of serovars than bivalent vaccines.
  3. We hereby give an assurance that we will take all possible steps to avoid a breach of the above undertaking.

Additionally, pursuant to Rule 4.8, the Committee made a report to the Board of Management, regarding the Respondents disregard of the Code, for their consideration. The Board met to consider the report on 2nd July and the Case is now closed

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Case No. 290/05/15 : MSD Animal Health / Bayer ‘No Bite is Right’ Advertising Strapline

The Committee found that there was no breach of the Code of Practice for this Case.

The case involved a complaint brought by MSD Animal Health against Bayer Animal Health concerning the latter’s advertising strapline ‘No Bite is Right’ which has been included in advertisements in the Veterinary Press (Vet Times March 2015 full page advertisement, on consumer-facing waiting room materials) and (as was emphasised at the meeting), also in social media.

The Complainant alleged that the Press Adverts as well as the use of the ‘No Bite is Right’ strapline within consumer materials and social media posts, would suggest that certain products are available which effectively achieve the total eradication of tick bites on the pet. In making this complaint the Complainant drew attention to the conjuncture of the ‘No Bite is Right’ strapline with the relative size of the text ‘tick attaches to feed’ and ‘cutting out one step makes the difference’. It was suggested that this would infer to a reasonable person that the Respondent alleges 100% efficacy in repelling ticks before they have the opportunity to bite a pet. It was maintained that these elements give the impression that there are repellent products available which are able to prevent transmission of infectious diseases through preventing the tick from biting the animal. The Complainant alleged that it was their view no company can state that their product categorically prevents a tick bite or prevent the transmission of infectious diseases by these parasites and as such, is misleading to both the veterinary profession and to the public and that when made available to such promotional items, the disclaimer text was in such small print a reasonable person (particularly an average customer) would not notice it.

Additionally, the Complainant maintained the strapline infers that products that utilize a systemic mode of action are inferior to those that utilize a repellency effect. It was the Complainant’s view that such a categorical statement can only be interpreted as “any bite is wrong” which is disparaging to licensed competitor products.

In that event, at the meeting, that additional issue was orally given greater emphasis by the Complainant.

As such, the Complainant alleged that the ‘No Bite is Right’ strapline contained within the advertisements breached Clause 4.1(iii) and 4.1(iv) of the Code of Practice which Clauses are recited in full below:-

4.1 A Promotion of Animal Medicines must:

(iii) not be misleading (directly or by implication);

(iv) not directly or by implication disparage the products or services of other companies;

The Respondent maintained that the ‘No Bite is Right’ strapline should not be considered in isolation but must always be viewed in the context of the materials in which it appears and the wider information provided. The simple ‘No Bite is Right’ logo format is only used in Vet-facing items; in Consumer-facing items, the ‘No Bite’ logo contains a second line of information below it – “Help Stop Parasites Feeding On Your Pet”. The Respondent maintained that the SPC statements for Seresto and Advantix support the content of the advert, specifically the fact that with these products, ticks are not required to attend and feed in order to die. The Respondent recognised the mode of action is that ticks are repelled from the treated animal and therefore do not have to attach, hence the Respondent crossing out the headline statement “Tick attached to feed”. Furthermore the product SPC’s include statements specifically confirming that feeding is not required for clinical efficacy. The Respondent stated that they have never claimed that the use of Adantix or Seresto will stop every tick bite; indeed, every tick product carries a warning to the effect that one cannot totally eliminate the risk of a single tick bite and this is acknowledged in the Respondent’s materials and reiterate that as stated on the SPC’s for Advantix and Seresto, animals do not need to be bitten for these products to exert their effect and the Respondent maintained that this has to be of benefit to the animal. As regards the consumer facing/social media examples, the Respondent points out that these were not previously raised as a concern in inter-company correspondence, and emphasised the second line of information “Help Stop Parasites Feeding On Your Pet” which in the Respondent’s opinion makes the sentiment of the message clear, considered by the Respondent to be educational, namely highlighting the need to try to avoid bites in general. The Respondent stated that there is no intention to claim its product has the ability to completely eradicate all bites.

The Chairman opened discussions, prior to presentations and without representatives in attendance. He drew careful attention to the context of the various forms of advertisements containing the strapline, both to Vet-facing and consumer-facing forms; the precise terms of objection drawing attention particularly to the two paragraphs in the official letter of compliant referable firstly to Code of Practice Clause 4.1 (iii) (misleading) and secondly to Code of Practice Clause 4.2 (iv) (disparagement). He then referred to the Respondent’s products’ SPC which he considered were useful in considering the complaint, drawing attention particularly to the indications for use referable to Seresto at paragraph 4.2, and the reference to the product having “persistent acaricidal (killing) efficacy against tick infestation and repellent (anti-feeding) efficacy against tick infestations for ……. 8 months” as well as indirect protection against the transmissions of the pathogens from the tick vector “…. thereby reducing the risk of canine babesiosis and canine ehrlichiosis for 7 months”. He also drew attention to the pharmacodynamic particulars of the product as set out in paragraph 5.1 of its SPC, whereby “the active substances spread from the site of direct contact over the entire skin surface”, and that “…studies have established that imidacloprid reached the systemic circulation transiently while flumethrin was mostly not measurable. Oral absorption of both substances is not relevant for the clinical efficacy.” Likewise, paragraph 4.2 containing the recommendation of removing ticks on the dog was mentioned, as was the small print contained on the Vet-facing advertisements for both ticks and fleas. He invited comments from Members of the Committee.

A number of comments were made by Members, which, summarising the same, included the following:

  1. The statement was true : no bite is right for an animal. Therefore it was an honest statement of fact.
  2. There are two main methods of treatment:
    1. repel the tick or flea, so it does not bite; its effect was likened to the parasite landing on a hot surface when it landed on the animal’s fur so that it was uncomfortably hot, like a human putting hand on a hot surface. This was the Respondent’s products’ method of working; and
    2. systemic means, that is to say putting a substance into the animal’s blood which when ingested by the tick or flea on biting the animal will kill it. That was the Complainant’s product’s method.
  3. The advantages of the repellent can be said to be the prevention of bites which it is good to avoid for several reasons, not just prevention of disease carriage; whilst the advantage of systemic means is the longer duration of efficacy, immune from environmental circumstances or activities of the animal which could remove a repellent (e.g. swimming or heavy rain).
  4. Neither form of treatment could be considered 100% effective, which was in line with most medical treatments, which most people, whether qualified or not, fully understood.
  5. Both forms of treatment were POM-V’s, which therefore would require a qualified person’s prescription, and therefore, one can reasonably view the advertisement that veterinary advice would be forthcoming, to determine which treatment in each particular case would be appropriate – notwithstanding the desire that promotions should not mislead members of the public, such as to create a mind-set which has to be overcome by veterinary advice.

The parties’ representatives were invited into the room.

The Chairman introduced himself and the Committee to the party’s representatives. Having explained that the Committee had read all the material papers relating to the complaint, the Chairman invited the Complainant’s representatives to make their presentation.

The Complainant’s representatives maintained that the strapline, in the form supplied, was a categorical statement, compounded by the size of its text, and the comparatively small size of the disclaimer text, which gave a misleading message, implying that repellent treatments against tick and flea parasites were superior to systemic treatments.

In answer to the Chairman’s query, the representatives agreed that they accepted that prevention of parasites biting animals was entirely appropriate, but the strapline in their view gave a message that called for a judgement on appropriate treatment based on a suggestion that no ticks will ever bite if the repellent treatment is used, and that could not be substantiated, in that it could never be stated that the parasites will never bite the animal, even if it had been treated with the Respondent’s repellent.

The Chairman sought clarification as to whether the issues of complaint were:

(1) that the message given by the strapline inferred 100% efficacy when the Respondent’s repellent is used; but also, as a separate issue

(2) that the promotion implies that it is necessarily better to rely on the prevention of biting then alternative treatments, which rely on the flea or tick biting the animal, so that they receive from the animal’s blood a product that kills them.

In response, the representatives maintained that the strapline was inferring a preferable form of treatment by repelling the parasite to systemic treatments, which was thereby disparaging those alternative forms of treatment.

The question of the two elements of complaint: wrongly suggesting 100% efficacy on one hand and wrongly suggesting repellents are a superior form of treatment than systemics was closely questioned by the Chairman to establish clearly the manner in which the Complainant sought to argue that the strapline, in the manner used in the advertisements, was in breach of Code of Practice Clauses 4.1 (iii) (misleading) and 4.1 (iv) (disparaging).

The Complainant’s concern was that the message given by the strapline was a gross simplification which could not be justified – the Respondent’s repellents could not be said to be 100% always effective and were not always in all circumstances safe to rely upon as the only form of treatments for parasites.

In support of the 100% efficacy argument, the Complainant drew attention to the crossing out of the words: “tick attaches to feed”, which in the representatives’ view, will be read as: “tick does not attach to feed”. Likewise the text stating: “cutting out one step makes the difference”, in conjunction with the categorical strapline and image, suggested that Bayer’s product can completely eradicate parasitic feeding. The relative sizes of text, providing the disclaimer, would fail adequately to make known to the reader the qualification of the wrong message, given by the strapline.

In support of the superior form of treatment than systemic pesticides argument, emphasis was given in answer to several questions both from the Chairman and Members of the Committee, the message given by the strapline failed fairly to make known that repellents will rarely have the duration of effect that systemics have; that repellents can be ineffective once washed off through the animal becoming wet or drenched and that the advertisement could give a wrong impression of superiority in all circumstances, which was misleading and disparaging.

Some of the questions raised by the Committee were:

(a) that repellents helping to prevent bites were providing a benefit not necessarily only relating to disease, which was accepted by the representatives;

(b) that risk is reduced if the parasite does not bite – again accepted by the representatives, with the qualification that it was not possible to claim 100% efficacy in preventing bites by use of repellents.

(c) in answer to the question as to how long systemic treatments were effective before being “washed out”, the representatives maintained an average of 12 weeks, if used properly.

(d) that systemic treatments were not affected by rain, to which the representatives agreed.

(e) that a number of factors can prevent transmission of disease, to which the representatives agreed but suggested that there was common ground that both forms of treatment, in working as designed, would help to reduce disease.

(f) to the direct question: in what way did the Complainant consider its systemic treatment was better than the Respondent’ s repellent treatment, the representatives maintained a longer duration of control with greater confidence of efficacy, whatever the environment in which the animal existed or its activities; maintaining 100% effectiveness over a 12 week period. This latter comment was subsequently clarified, after questioning by the Chairman, to the intent that the representatives were not saying a parasite would never introduce disease during the 12 week period; just that they could confirm the treatment was active for at least 12 weeks.

(g) in answer to the suggestion that any reader would accept the strapline was inevitably simplistic as an advertising “puff”, the representatives maintained its emphasis in text and image with very small text disclaimer could give an wholly inaccurate implication of the benefit of the product, which could mislead both the public and veterinary surgeons into believing repellents to be always the superior form of pesticide.

The Complainant’s representatives concluded their presentation, drawing attention to the use of the strapline in social media, which by its nature would emphasise the concerns of inaccuracy and disparagement, as maintained by the Complainant.

The Chairman acknowledged the two issues of complaint raised but pointed out the written complaint had concentrated on the 100% efficacy argument rather than the secondary argument of the Respondent’ s repellent being alleged to be a superior treatment.

The Chairman invited the Respondent’s representatives to make their presentation.

They set out in first instance the circumstances why the meeting was being held, emphasising the wording of the strapline, which was they stated was misleading, in breach of Code of Practice Clause 4.1 (iii) and, in breach of Clause 4.1 (iv), disparaging of the Complainant’s product.

They emphasised their view that the advertisements containing the strapline did not imply 100% efficacy by a repellent treatment. It was common ground that repellents prevented ticks biting animals, but there could never be 100% efficacy and no reasonable reader would take the strapline as meaning that.

In the context of Code of Practice clause 4.1 (iv), the suggestion that the strapline implied systemics were inferior was rejected by the representatives. They emphasised the common goal of both treatments, which is to remove the pathway of ticks and fleas and the transmission of disease. The representatives read out the relevant elements of the SPC statements in the context of the content referable to their repellent product and suggested that the strapline was entirely consistent with the indications given by the SPC.

In the Respondent’s representatives’ view the pivotal issue was the prevention of parasites taking a blood meal. This was an entirely rational aspiration reflected by the strapline. Parasitic bites caused irritation and can transmit disease and it was entirely justifiable to emphasise, in the health and welfare context, the justification in seeking a preventive cure in both cases. The problems of bites from parasites could be serious and can even, in extreme circumstances, be fatal. There was absolutely nothing wrong in emphasising those benefits, but in no way was the Respondent suggesting that there was no place for systemic treatments. They emphasised the speed of transmission, which varies, depending on the disease, but can be as quick as three hours. Tick disease could be transmitted within a minute of the existence of parasites on the animal and can also cause skin disease. They suggested that the strapline related to an aspiration, to which there cannot be any reasonable objection.

In answer to the Chairman’s question as to what the Respondent meant by the strapline, the representatives said that it was not meaningless but was an aspiration to drive down the challenges caused by parasitic bites to as great a degree as possible. The Chairman then asked how they distinguished their arguments as regards the consumer facing advertisement compared to the veterinary facing advertisement. The Respondent’s representatives in answer stated that in terms of trying to reduce the exposure of the animal to ticks and fleas, it was reasonable to have a campaign to make known the aspiration. They acknowledged this would not always produce a positive response but maintained there could be no reasonable objection to the communication of the means to prevent parasitic bites and that the avoidance of that was a necessity that could not be challenged. Notwithstanding the justification of such a campaign, however, the representatives emphasised that it was necessary to see the strapline in the context in which it was put in both forms of advertisement and suggested that the explanatory text in the vet-facing advertisement would be fully effective to the qualified reader, whilst the extra words supplied in the consumer facing advertisements served to put the strapline in the right context, whereby such a reader would properly understand what was being stated, and not be misled.

The Representatives made an examination of the respective SPC’s for both their product and that of the Complainant’s, drawing attention to the relevant material words.

In answer to the Chairman’s query, they agreed that repellent and prevention went hand in hand. They suggested that the two categories of treatment were not directly comparable and each could be necessary in differing circumstances relating to the required treatment for the animal.

Again, in answer to a Chairman’s query, the Representatives suggested that the relative effectiveness of the two treatments were much the same: around about 98%.

The Representatives again went through the differing wordings referable to the flea advertisement compared to the tick advertisement, and the vet-facing advertisement compared to the consumer- facing advertisement; and emphasised that they could not see there could be any suggestion of disparagement of alternative treatments: systemic or otherwise. They responded to suggestion that the advertisements implied that application of treatment by tablets made that treatment inferior to repellents, that the advertisement was simply drawing attention to a different form of application and in no way was the strapline or the advertisements disparaging the application of treatment by tablet.

In answer to the Chairman’s further query, the Representatives confirmed that there would never be a circumstance, even within social media, where the strapline would be used on its own, without any qualifying or contextual words.

They emphasised that the strapline’s purpose within the advertisements was genuinely educational.

In answer to a query from a Member, the Representatives confirmed that the effect of the repellent was like a tick landing on a hot plate, forcing it to withdraw immediately. They confirmed that if the tick has not bitten, it cannot cause disease. They confirmed that there were, of course, other repellents on the market. They emphasised that both forms of treatment require prescription from a qualified person who would be in a position to choose which treatment was more appropriate in the circumstances which appertained.

The Respondent’s representatives concluded their presentation by emphasising that the advertisements were carefully prepared to ensure that the message given by the strapline was qualified appropriately, depending on the form of reader: qualified or unqualified. They pointed out that the Complainant had not disputed the assertion that the strapline contained a fundamental truth: parasitic bites were not ever going to be “right”. There was a fundamental difference in approach by the two treatments: repellent as opposed to systemic; but that does not in any way detract from the justification in the use of the strapline within the context in which it had been used in the advertisements in question and that accordingly there was no breach of the Code of Practice.

The Chairman thanked both parties’ representatives for their excellent presentations and released them from the meeting.

A lengthy discussion then ensued. The unanimous decision of the Committee was that the strapline “No Bite is Right”, when considered within the context of the Veterinary Surgeon-facing promotion or the Consumer-facing version, would not mislead the reader or make the reader consider any competitor’s product was being disparaged.

The Committee considered that the reader of the strapline (whether a veterinary surgeon or consumer) would not attach much meaning to it on its own and that, in the context of the relevant promotions, would perceive the strapline as simply informing the reader that it was not necessary for a tick or flea to bite an animal to prevent it from being infected against tick or flea-borne diseases and that accordingly, the reader may prefer to use a repellent (preventative) treatment to prevent the transmission of vector-borne diseases.

The Complainant’s complaint was twofold. The focus of its written complaint was that the strapline in the context of the promotions implied that the Respondent’s product was 100% effective in preventing tick or flea bites. The Committee disagreed that the reader would infer such. In its view, neither the strapline nor the promotions implied such and none of the language suggested such. The Committee took notice of the fact that veterinary surgeons (and to a lesser extent, consumers) are aware that as a rule, animal care products or pharmaceuticals are rarely 100% effective. Furthermore, insofar as such may have been suggested, this was negated by the small print at the bottom.

In oral submissions, a greater focus was placed on the fact that the strapline implied that repellent-based treatment was more clinically efficacious at preventing companion animals from being infected with tick or flea-borne diseases than systemic-based treatment. The Respondent denied that such was the inference that veterinary surgeons or consumers would draw from the strapline or promotions.

The sentiment that it was difficult to envisage a situation where one would encourage the biting of an animal by a parasite and as such could be justified as a fundamental truth in the overall aim of any ectoparasiticide was common ground between the parties. In the Committee’s view, the strapline, particularly when viewed in the context of the promotions, was aimed at promoting such a truth and did not imply that it had superior clinical efficacy to systemic parasiticides. Rather, the strapline when viewed in the context and wording of the promotions was informing the reader that ticks and fleas could be killed without the necessity of them having to bite the host. Such was reinforced by the strikeout in the wording of the promotions of “the flea must feed” or “the tick attaches to feed” and the wording “they are not required to bite in order to be killed” and in the consumer-facing promotion, the correct statement that “ticks that die before they bite cannot spread diseases, such as Lyme’s disease” and the wording “Help Stop Parasites Feeding On Your Pet” below the strapline.

Accordingly, the Committee’s view was the strapline “No Bite is Right” would not mislead the consumer. The Committee also took the view that the strapline did not disparage expressly or implicitly competitor products. In particular, this followed because (i) the reader (whether professional or a consumer) would not consider that it was implying that repellent-based treatment had greater clinical efficacy than systemic-based treatment or in any way, mislead the reader (ii) there was no ‘”direct attack” on any systemic-based methods of treatment (iii) the word “disparage” should not be equated with “superior to” but required something more akin to belittlement or denigration of a product.

Accordingly, the Committee found that there was no breach of Code of Practice clauses 4.1 (iii) or 4.1 (iv), as was alleged by the complaint.

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