2018 cases

Precis of Committee Meetings held in 2018

Case 298/08/18: Boehringer Ingelheim Ltd/MSD Animal Health: Marketing of Bovilis BVD

Case 298/08/18 revolved around the marketing of Bovilis BVD, and contained 2 items, those being:

  • ITEM 1 : The strapline ‘I. or not P.I? That is the question!
  • ITEM 2: The selective recital of the SPC for the product.

The Committee upheld Item 1 of the Complaint as being in breach of the NOAH Code, but dismissed Item 2.

Boehringer Ingelheim argued that the complete advertisement by its tagline ‘P.I. or not P.I.? That is the question!’ failed to put proportionately, and in a balanced way, its highlighting of the potential risk that a calf born to a dam vaccinated with a live vaccine (which Boehringer Ingelheim alleged was implied would not arise with use of inactivated or non-live vaccine) during pregnancy may test positive due to the presence of the live vaccine virus in an ear notch sample. Adjudication was sought on both the original and amended promotional material, as they did not consider the inclusion of “in limited cases” and the removal of “Not if you vaccinate with Bovilis BVD” adequately addressed their concerns, or meant that either the farmer or vet advert was now compliant.

Boehringer Ingelheim’s representatives made the following points regarding item 1:

    1. The implication of the campaign is that if you use Bovilis BVD only PI calves will test positive on an ear notch test – so there will be no confusion.
  • 15% of positive ear tags will not be PIs, whether Bovilis BVD has been used or not.

2. The implication is also that use of Bovela is a significant cause of positive ear notch results.

  • The lack of context provided to the reader that only 7 PI cases arising from the use of live vaccine have been identified across the whole of Europe, compared to, for example, the several thousand PI cases from transient or other causes identified in Ireland alone.

3. An averagely well informed reader may infer from the material that the use of Bovela may cause PIs, when this is not the case.

4. Eradication of BVD relies on the industry working together to maintain confidence in the process and educate farmers of the dangers of BVD.

  • It was contended that this campaign reduces the confidence of farmers eradicating BVD with regards to vaccination and testing, which has the potential to undermine both the voluntary programmes in England and Wales and the compulsory programmes in Scotland and Northern Ireland.
  1. The implication is that use of Bovela is a significant cause of positive ear notch results.
  • The Representatives repeated their comment as given in 2 above, concerning the proper context not being provided.

6. The campaign is not primarily concerned with education and does not provide a call to action to discuss retesting of positive tag tests with their vet.

  • It was alleged that the campaign could dissuade farmers away from using the vaccine Bovela.

Regarding item 2 of Complaint, it was maintained that by only citing part of the SPC an averagely well-informed reader could be led to believe that the need to retest after 3 weeks is unique to the progeny of dams vaccinated with Bovela, which is incorrect and emphasises wrongly by not stating that retesting is the standard diagnostic approach to confirming the BVD status of animals which test ear notch positive.

MSD maintained that the statements in the advert in question do not cause confusion or attempt to undermine the national eradication schemes but are providing education to exercise caution when interpreting notch-test positive results in certain situations.

MSD’s main points were:

  • That their original and amended materials were compliant with the NOAH Code of Practice, amendments were made as a gesture of goodwill and not as an admission that the initial campaign was not in compliance with the Code.
  • The advice is to retest when an animal tests positive, but that the reality is that in practice culling immediately often follows a positive ear notch test. This is because:
    • The probability is the animal is PI
    • The logistics of isolating animals and concerns about virus shedding while awaiting retesting
    • Animals often die of complications of BVD before re test is completed.
    • The farmer’s accreditation status is lost
  • Prior to 2015, when Bovela came to the UK market, there was no awareness of potential for foetal transfer of the vaccine virus to occur, and therefore vets and farmers need to be made aware that this can affect test results. Inactivated vaccines do not carry this risk. These are factually true statements, the advert making reference to the SPC, and no quantification is thereby implied or given.
  • The Farmer and Vet advert were both educational and the Farmer version clearly advised talk to your vet. Both parties need to be aware of the differences in vaccines.
  • Regarding item 2, MSD selected the aspects from the SPC they felt relevant to the topic of discussion, which was not the whole SPC, or eradication, being referable to ear notch testing.

The unanimous decisions of the Committee were as follows: –

ITEM 1 :     ‘P.I. or not P.I? That is the question!

The Committee found that both the original and amended versions of the promotional leaflet and advertisements with the tag-line “P.I. or not P.I.? That is the question!” were in breach of the Code of Practice.

Although it was factually correct to say that modified live BVD vaccines such as the Complainant’s Bovela® did give rise to a very small number of false positives for Persistent Infection on ear notch testing whereas an inactive vaccine such as Bovilis® sold by the Respondent did not, the promotion implied that an accurate diagnosis of BVD could be made more readily through ear notch testing if Bovilis® was used but not Bovela®.

In fact,

  • 85% of all calves identified by ear notch testing as being Persistently Infected (P.I.) are correctly diagnosed. In other words, only 15% of ear notch tests are false positives.
  • The major cause of the (15%) false positives on ear notch testing is due to transiently infected calves. A much more minor cause of false positives is the use of a modified live vaccine during certain stages of pregnancy, and using certain tests.

These two critical facts are not made clear on the promotional literature and the Committee’s view was that such facts are not well-known amongst veterinarians nor livestock farmers. Whilst the Respondent had amended the wording in very small font in the footnote to refer to “limited” cases (to reflect the SPC), such did not remove the overwhelming implication that only dams vaccinated with Bovilis ® but not Bovela ® would lead to a correct ear notch diagnosis of P.I. in new born calves.

Accordingly, the promotion was not balanced, was unfair and misleading. As such, the promotion was in breach of Clause 4.3(i), (ii) and (iii). However, the Committee did not find it was in breach of Clause 4.3(iv) (that it was disparaging of Bovela®), or in breach of Clauses 4.3(vii) or 4.4 (ii), which had also been cited in the Complaint.

The Committee’s clear view was that the marketing campaign literature’s primary intention was to promote Bovilis® and not that of education. The committee view was that an insufficient attempt had been made to educate about the facts relating to BVD and P.I. and its diagnosis. Accordingly, the Respondent was also in breach of Clause 4.6, as such leaflets and advertisements had been aimed at farmers.

ITEM 2:   The selective recital of the SPC for the product.

Regarding the second item of complaint, the failure to include the whole of a paragraph of the SPC for Bovela®, the Committee did not consider that the missing sentence affected the meaning of what was included. It was well known that the cornerstone of BVD eradication was identification and culling of P.I. animals but even if not well known, the omission of it did not affect the meaning of what was quoted in the Respondent’s advertisements. Accordingly, this second item was dismissed and no breach was found.

The Committee made comment that BVD is a serious issue and that schemes to try to eradicate the disease are in their infancy in England, and voluntary at the moment.  Given this issue, the committee is concerned about any message that could reduce confidence in vaccination, reduce confidence in tagging and ear notch testing or which could make farmers question the protocol laid down by their vet regarding vaccination and testing.

Following the case MSD Animal Health are required to sign an Undertaking which states the following;

Case No. 298/08/18

  1. We acknowledge the decisions of the Committee in Case 298/08/18 as set out in your letter of 31 August 2018.
  1. To be completed in all cases

We accept the decision of the Committee and undertake that the practices in question (if not already discontinued) will be discontinued forthwith, and we undertake not to:-

  • Market or promote to farmers or non veterinarians marketing material which is the same or substantially the same to the marketing material used for the “P.I. or not P.I. – that is the question” campaign (whether in the amended or unamended form) or use other material which is not primarily concerned with educating farmers or non-veterinarians about the risks of BVD and/or how to test for it.
  • Promote Bovilis BVD to anyone using marketing material which
  1. is the same or substantially the same to the marketing material currently used for the “P.I. or not P.I. – that is the question” campaign;
  2. states or implies that only using Bovilis BVD or other inactive vaccines will enable a veterinarian or other person to make an effective diagnosis by ear notch testing of whether or not a new born calf is Persistently Infected (“I.”);
  3. expressly or impliedly suggests that using an active vaccine such as Bovela will lead to a wrong diagnosis of P.I. save that it shall not be a breach of this undertaking to make a statement whose gist is that in some limited cases, an active vaccine such as Bovela may give rise to a false diagnosis that a calf is P.I. provided that the wording “in some limited cases” is given substantially the same prominence as the remainder of the statement.

Case No. 296/07/18: MSD Animal Health/Zoetis UK Limited: Switch and Grow marketing materials

The Committee found Zoetis UK Limited to be in breach of 2 of the 3 items that were the subject of the case hearing.

The case related to a Zoetis advertising campaign card, the front of which used the tagline “Switch and Grow with Zoetis” with quotes from a number of vet practices regarding their relationship with Zoetis, the reverse featuring a comparison between Stronghold Plus and Bravecto Cat, and Simparica and Bravecto Chewable Tablet respectively.

The items under consideration were as follows:

  • ITEM 1 – The strapline “Switch and Grow” on both the cat and dog leaflets
  • ITEM 2 – The reference in the comparison table to Bravecto® being “licensed for 12 weeks leaving protection gaps if prescribed for 3 monthly (13 weeks) dosing on the cat and dog leaflets.
  • ITEM 3 The wording “Low volume dose, 0.5ml, providing your owners with a convenient application, with no need to wear gloves for improved owner compliance on the cat leaflet.

MSD stated that the use of the tagline ‘Switch and Grow with Zoetis’, which was found in all three versions of the promotional literature, implies that vet practices will grow their business when switching from Bravecto Cat or Bravecto Chewable respectively, to a Zoetis product, for the following reasons:

  • The wording ‘Switch and Grow’ is found on a double-sided piece of marketing material, which MSD believe cannot be seen as a general message when directly juxtaposed with the comparison table comparing products, therefore implying, and leading the reader to assume, that switching products will help their business to grow. MSD alleged that if it was a general message, it would contain a table with all competitor products to offer a fair and balanced view, instead of a direct comparison.
  • As the quotes on the front are not referenced to specific products, the implication is that the quotes are from practices that switched from MSD’s Bravecto and grew with Zoetis and their products.
  • The term ‘Switch and Grow’ is not quantified with any case studies in which it is proven that business’ grew switching from Bravecto.

Item 2, which referred to the wording “licensed for 12 weeks leaving protection gaps if prescribed for 3 monthly (13 weeks) dosing” used on the comparison chart, was felt to be unfair by MSD as it did not compare the licensed dosing regime for both products, instead assumed a 3 monthly prescribing regime for the MSD product, which they had at no point promoted. They therefore felt the comparison did not give an equal comparison of both products using the licensed dose rates and intervals.

  • They did not dispute that vets may prescribe the product every 3 months, however the SPC states 12 weeks.
  • Zoetis are using an off-SPC dosing regime to imply there can be a protection gap with no substantiation
  • Comparisons should reflect the SPCs of both products to be fair and balanced.

Regarding Item 3, in which the Zoetis campaign card compared their Stronghold Plus to Bravecto Cat, using the volume (in ml) of product applied in a single application and the need/ or lack of need to wear gloves during application, MSD felt that there is no substantiation for the fact that a lower dose volume or not having to wear gloves improves owner compliance.

In response to Item 1, Zoetis maintained that:

  • The format of the advertisement was used generically across their entire campaign
  • The message being conveyed was to encourage the use of a range of Zoetis products and was not focused on individual products. The message was to encourage practices to work with Zoetis to help grow their businesses
  • No reference, inference or claims made about “switching from A and growing with B”
  • Their entire campaign focus is on strengths of Zoetis and benefits of working with Zoetis
  • Aligned to their core strategy – improving compliance
  • The same case studies quoted on all pieces, not specific and purposefully generic
  • Competitor and own brands included in data
  • The card substantiates the word “Grow” within the phrase “Switch & Grow” by referring to case studies

Regarding item 2:

  • Zoetis agreed that at no point had MSD promoted their product with an off-SPC dosing regime, and stated that their intention was to educate vets and front of house staff that if Bravecto is administered less frequently than the SPC schedule (12 weeks) a period without protection will result.
  • Their survey of practice dispensing labels showed that frequently Bravecto is dispensed by vets with a 3 monthly dosing interval
  • Version 3 addressed the “lack of substantiation of this statement” by referencing Zoetis’ investigation of prescribing habits.

In reference to item 3, Zoetis stated that they were trying to convey to the reader that when administering any single dose of Stronghold Plus in comparison to Bravecto Spot-On for cats, there is no SPC requirement to wear gloves and that the physical dose volume is lower. They argued both are relevant factual points of differentiation to communicate.

The decisions of the Committee on the 3 items put before them were as follows:

Item 1

The strapline “Switch and Grow” on both cat and dog leaflets of both Versions 2 and 3 by reason of its context being specifically

  • the reference to Stronghold® Plus/Simparica®
  • the reference to “What is Your Active Clients’ Current Flea and Tick Compliance Rate”
  • the comparison table between Stronghold®/Simparica® and Bravecto® (Cat and Dog) on its reverse)

was held by the Committee, by a majority decision with 2 abstentions, to breach the Code as it implied that switching from Bravecto® to Simparica®/Stronghold® would increase the revenue of a veterinarian practice (“the Implication”).  The Implication was unfair, misleading, and unsubstantiated, contrary to Clause 4.3 (1) and (iii) and 4.4 (iii).

The Committee accepted and noted that the bubbles on the front page, claiming growth in veterinary practices, were expressed in a general manner but in the Committee’s view, such did not detract from the implication that a switch to Simparica® and/or Stronghold® would enable a veterinarian practice’s revenue to grow. Furthermore, given the Committee’s finding as to the Implication, what was said in the bubbles did not substantiate the Implication. For instance, there was no data to show that switching from Bravecto® to Simparica®/Stronghold® would increase revenue (and such seemed unlikely).

Item 2

The unanimous decision of the Committee was that the reference in the comparison table on the reverse of the leaflets relating to both dog and cat whereby it referred to Bravecto® being “licensed for 12 weeks leaving protection gaps if prescribed for 3 monthly (13 weeks) dosing” implied that there would be a gap in protection if Bravecto® was only used every 3 months.

The Committee felt that whilst, in some cases, a veterinarian might prescribe for 3 months rather than 12 weeks (and that some evidence had been supplied to support that), it was unfair to promote an animal medicine by referring to the use of a competitor’s product not in accordance with the SPC when MSD had not promoted or advertised (or encouraged) off-SPC use.  The treatment intervals that may be used by some vets (where not in accordance with the SPC) cannot be considered the responsibility of MSD.

Accordingly, this item was unfair, contrary to Clause 4.3(i).  This finding was therefore referable to both versions 2 and 3.

Item 3

The unanimous decision of the Committee was that the reference in Version 3 to “Low volume does, 0.5ml, providing your owners with a convenient application, with no need to wear gloves for improved owner compliance”  when comparing Stronghold® to Bravecto® Spot On for Cats was factually correct and did not mislead by implication by the use of the phrase “for improved compliance”.  It was agreed by the Committee that it was self-evident that not having to use gloves would be more convenient for the user and improve owner compliance. Therefore, no breach was found.

Following the case Zoetis UK Limited Health are required to sign an Undertaking which states the following;

Case No. 296/07/18

  1. We acknowledge the decisions of the Committee in Case 296/07/18 as set out in your letter of 10 October 2018.
  2. To be completed in all cases

We accept the decision of the Committee and undertake that the practices in question (if not already discontinued) will be discontinued forthwith, and we undertake, in relation to our products Simparica® and Stronghold Plus®:-

  • Not to use the strapline “Switch and Grow” in an advertisement that compares the characteristics of Simparica ® and/or Stronghold Plus ® as against Bravecto® such as to imply that switching to Simparica® or Stronghold Plus ® from Bravecto® would increase the revenue of a veterinarian practice
  • Not to use a statement that Bravecto® is “licensed for 12 weeks leaving protection gaps if prescribed for 3 monthly (13 weeks) dosing” to promote Simparica® or Stronghold Plus® or wording which has the same meaning or effect where the owner of the SPC for Bravecto® had not promoted or advertised (or encouraged) such a prescription.