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At its meeting in June 2015, the NOAH Code of Practice Committee heard one case where MSD Animal Health was found to be in breach of 6 of the 8 items under complaint; 3 by concession of the Respondent and 3 by adjudication by the Committee.

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 L4 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.
Additionally the Committee referred the case to the NOAH Board of Management for their consideration. The Board discussed the case at their recent Board meeting and the case is now closed.
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:- 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