Code of Practice for the Promotion of Animal Medicines

Précis of Committee meetings held in 2010

• 279 : Norbrook Laboratories/Merial Animal Health : Ivomec Super
• 280 : Merial Animal Health / Boehringer Ingelheim : Metacam promotion

Case No. 279. Norbrook Laboratories/Merial Animal Health: Ivomec Super

This case, against Merial Animal Health, was brought to the Committee by Norbook Laboratories Limited, (a non member of NOAH). Originally, there were three items, but item two was not considered, as this was under separate and independent investigation by the VMD.

The Chairman summarised the case as follows:-

Item One.

This related to the table on page 3 of the Respondent’s brochure, which had a heading "Cattle Flukicide Efficacy Based on Data Sheets." The complaint was that Closamectin Injection was listed in this table as being effective against fluke, aged nine weeks and older when in fact, the period is seven weeks and older, contrary to Code of Practice clauses 4.2, 4.3, 4.5, 5.5 and 7.10. The Chairman asked the Committee to note that the Respondent in its formal response did not seek to dispute the facts alleged.

Item Three

The Chairman summarised the background relating to the issues raised as item 3, which had originally sought to suggest that statements in the brochure had been made against products, which appear to be efficacious. On page 6 entitled "Heading the Field In Convenience", a comparison was made between Ivermectin and Closantel endectocide (Closamectin Injection) in relation to dose rate and the viscosity, not efficacy, which was said to be contrary to Code of Practice clauses 4.3, 4.5, 5.5 and 6.1. However, following a request for clarification, the Claimant effectively set out new grounds of complaint, which constituted three parts:-

1. The words: "super efficacy" in the brochure, constituted a superlative; contrary to Code of Practice clause 5.2;

2. The use of the heading "Leading the Field in Convenience" in the brochure suggest, wrongly for the promoted product, greater convenience, when compared with the Complainant's own product: Closamectin "Pour On", contrary to Code of Practice clauses 4.2, 4.3, 4.4, 5.2, 5.5, and 6.1;

3. The use of the heading: "At the Forefront of Performance" linked to the statistics on pages 7 and 8 of the brochure, should have included Closamectin, maintained by the Complainant to be the leading endectocide, contrary to Code of Practice clauses 4.2, 4.3, 4.5, 5.2, 5.5, 6.1 and 7.10.

The clauses of the Code of Practice cited by the Complainant as being transgressed by the promotion are listed below:-.

4.2 Information about animal medicines must reflect current knowledge or responsible opinion.

4.3 Information about animal medicines must be accurate, balanced and must not mislead, either directly or by implication, so that critical unbiased judgements and decisions can be made.

4.5 All information included in promotional material must be capable of substantiation and substantiation must be provided within 5 working days unless there are genuine extenuating circumstances requiring a short extension. In that event, an explanation must be supplied within 5 days with an estimate of the time in which substantiation will be supplied.

5.2 Exaggerated claims must not be made and all-embracing claims and superlatives avoided. Claims must not imply that an animal medicine, or an active ingredient, has some special merit, quality or property unless this can be substantiated.

5.5 Comparisons of products must be factual, fair and capable of substantiation. In presenting a comparison, care must be taken to ensure that it does not mislead by distortion, by undue emphasis, or in any other way.

6.1 The products or services of other companies must not be disparaged either directly or by implication.

7.10 Where appropriate, for example in technical and other informative material, the date of printing or of the last review must be stated.

The Claimant's observers and the Respondent's representatives were invited into the meeting.

The Chairman explained that the Complainant had chosen not to be represented, and therefore would not be making any presentation. Accordingly, in this case the Respondent's representatives were invited to make their presentation alone.

The Respondent’s representatives provided the Committee with four original copies of the brochure containing the promotion the subject matter of the case, pointing out that these were the only original copies in existence, retained on file for reference purposes only, because stocks had been destroyed in accordance with the assurances that had previously been given to the Complainant immediately after they had received the complaint.

They stated that they had little to add to the comments already made in their Company’s formal written response. The key points were that:-

Item One.

The Respondent had ceased distribution of the brochure within two days of receipt of the complaint from the Complainant. It was estimated only 500 copies were distributed. The distribution had taken place in late July or early August 2009. Their understanding was that Closamectin Pour On, the Complainant’s own “pour-on” product, first became available in the market until later in September or October 2009. The complaint was received in October 2009. On becoming aware of their error the Respondent took immediate corrective action, by ceasing distribution, writing to known recipients, withdrawing and destroying stocks and giving the Complainant an assurance that the erroneous information would not be used in any future promotion. The error had occurred because Norbrook’s product was not in the NOAH compendium, because they were not participants, and so the Respondent had relied on what turned out to be an out of date detailer of Norbrook. On receipt of the complaint they checked the VMD website and realised that an error had occurred. It was also noted that the respondent had mailed a corrective letter to all known recipients of the detailer, a copy of which had been sent to the complainant and subsequently to the Code of Practice Committee.

Notwithstanding the acknowledgement of their error to the Complainant, and their assurances, it appears the Complainant still saw fit to make complaint not only to the NOAH Code of Practice Committee, but also to the VMD and to the Advertising Standards Authority.

Item Two – not for discussion.

Item Three.

This complaint appeared to have been altered retrospectively, after the brochure had been withdrawn, and commenting on a comparison with Closamectin Pour On which was not on the market when the brochure had been distributed.

Specifically in relation to the three sub-issues:-

(i) The use of the word “Super-Efficacy” being a superlative. The use of the term “Super” is part of the brand name, approved by the regulator. The product has become known by retailers – veterinary practices etc – as “Super”. In response to a query of the Chairman, it was stated that it was not the intention in the table on page three, referring to flukicide efficiency and elsewhere in the brochure, to make any claim to any superlative attribute to the product, and the representatives considered that different people would have differing opinions as to what the use of “Super” meant, but in the context of this brochure it was simply appending part of the brand name to the certain attributes of the product. In response to a member’s enquiry, the representatives confirmed that if (for example) the product’s name had been “Ivermectin-Gold”, they would have expected the same approach to have been taken – e.g. “Gold -Efficacy”. Another member queried why, if that was the case, did not the brochure incorporate the registered trade mark symbol in all such cases, to which the representatives said that whilst they understood the argument, they felt use of the term was a legitimate advertising technique which did not reflect use of a superlative, bearing in mind the target audience, and that the product’s existence with this name incorporating “Super” having been in the market place for over 20 years. In response to the Chairman, it was stated that use of this term in this way had previously been used in brochures in similar manner without objection.

(ii) The Respondent’s key argument was that the brochure had been released for publication before the Claimant’s “pour-on” version of its product Closamectin existed in the market place. The representatives acknowledged that the position would be very different if the brochure was being distributed now.

(iii) On the third part, the Respondent’s case was (a) the brochure was simply reciting a peer reviewed published study; and (b) the table accurately recorded reality in terms or performance referable to body weight gain. In response to the Chairman’s queries about the market share of the products listed in the table, it was stated that the representatives did not have precise data available, one of the listed product’s primary market was in Ireland, but they were confident that the combined market share of the products listed had the greatest market share based on this performance criteria, amounting to at least 50% at the time of publication of the brochure. Additionally (and in the representatives’ view critically) (c) the Respondent wholly disputes that at the time of publication of the brochure Closamectin was the leading endectocide. They fully acknowledged that that description might be correct today, following the introduction of the Claimant’s pour-on version, which has proved to be a successful product, but it was not the case then. In answer to a member’s query, the representatives stated that in their view “At the forefront of performance” simply meant amongst the leading brands.

The Respondent’s representatives having confirmed in response to the Chairman’s query that they had nothing more to add, they and the Claimant’s Observers were thanked for their attendance and left.

The unanimous decisions of the Committee were:

Item One

Incorrect data contained in the table on page 3 of the brochure which maintained that Closamectin™ injection was effective against flukes aged 9 weeks or older, when in fact, at the time the undated brochure was distributed, Closamectin was effective against flukes aged 7 weeks or older.

The Respondent did not seek to dispute the facts alleged. Accordingly the Committee considered that the brochure at the time of distribution was in breach of Code of Practice Clauses:-

4.2 (in that the promotion did not reflect current knowledge or responsible opinion about an animal medicine)

4.3 (in that the promotion did not provide accurate and balanced information about an animal medicine which could mislead directly or by implication)

5.5 (in that the promotion did not provide a factual or fair comparison which could be substantiated); and

7.10 (in that the informative material comprising the promotion failed to provide the date of printing or of the last review of it).

The Committee noted the Respondent’s explanation for the error arising, in that the Respondent relied upon an out of date detailer of the Complainant and would emphasise the need for members to ensure, when giving comparative data in promotions, that accurate and up to date data about medicinal products is used, which should be obtained by reference to the product’s SPC, and not other sources such as data sheets or brochures. The SPC of any authorised product can be viewed on the VMD’s website.

The Committee also noted that within two days of notification by the Complainant of the complaint, the Respondent had acknowledged its error and then ceased distribution of the brochure, sought to withdraw it from publication, sent a corrective letter to all recipients of the promotion items, destroyed all stocks of it and assured the Complainant that the erroneous data would not be repeated in any future promotion. Whilst the Committee in no way absolves the Respondent for a serious breach of the Code, it commends Merial Animal Health for its prompt and correct action, once its error was discovered.

Item Two

This item was not considered by the Committee as it is the subject of an investigation by the VMD the result of which is not yet known.

Item Three

This item fell into three separate parts, which effectively constituted new points of complaint in place of the original items of complaint, as part of a so-called clarification sought by the Secretary, following the Respondent’s request for clarification. The formal request for clarification (following an earlier intimation) was made on 8th December 2009; repeated on 15th and 28th of January 2010 and only provided on 5 February 2010.

The three separate parts were:-

a) The use of the term Super Efficacy and other adjectival usage of the word ‘super’ being contrary to Code of Practice Clause 5.2 (use of superlatives, exaggerations etc).

The Committee considered the promotion in this respect to be ‘close to the line’, bearing in mind the restrictive threshold imposed by this Clause is quite low. However, the Committee took into account (i) the product’s brand name utilised the word ‘Super’; (ii) that independent members of the Committee confirmed that within the market the product was known as ‘Super’ to distinguish it from other Ivermectin products; and (iii) (as again confirmed by independent members) the term ‘Super’ was not a superlative (as in “best”, “most effective” etc) and in modern day parlance would not be seen as implying a premium or superlative quality.

For these reasons the Committee considered there had not been any breach of the Code of Practice. The Committee, however, felt that usage of such adjectival terms within brand names was something which should not be encouraged.

b) Promotion of “the convenience” of Ivermectin by comparisons with other products which did not include Closamectin “Pour On” contrary to (in particular) Code of Practice Clause 5.5 (comparisons must be factual, fair and capable of substantiation).

The Committee accepted the evidence of the Respondent in the absence of any evidence being advanced to the contrary by the Complainant, that at the time of distribution of the brochure “Closamectin Pour On” was not available in the market and that the release of the brochure for publication by the Respondent was before “Closamectin Pour-On” entered the market.

Accordingly, the Committee held that there had been no breach by the Respondent of the Code of Practice based on the Clauses quoted by the Complainant.

The Committee did, however, note the failure of the brochure to display any date reflecting the time at which the informative material comprising the promotion was printed or last reviewed, as was already noted in relation to Item One.

c) The third element concerned the use of the heading ‘At the Forefront of Performance’ relating to a table disclosing body weight gain after use of various products working against flukes, which table fails to include Closamectin, claimed by the Complainant to be the ‘leading endectocide on the market”, again contrary to (in particular) Code of Practice Clause 5.5 (comparisons must be fair, factual and capable of substantiation). In that regard the Committee noted:-

i. that no evidence was produced by the Complainant to support (in the context of increasing body weight) their assertions that Closamectin at the time of the distribution of the brochure was the leading endectocide (whether generally or specifically for being effective against fluke);

ii. that in fact it appears that Closamectin Injection was not at that time a particularly successful product as opposed to Closamectin “Pour On” which was not on the market at the time of such distribution (as alleged by the Respondent but was also confirmed by independent members of the Committee);

iii. from evidence from the Respondent’s representatives, not disputed by the Complainant and confirmed by members of the Committee, it would appear that Ivermectin Super together with the other products compared enjoyed a significant part of the flukicide market share at the time of distribution of the brochure, and thus, it was a fair comparison and also (based on the published paper referred to in the promotion), it was indeed the best product of the four products set out in the table, in terms of increasing body weight gain and as such was substantiated; and

iv. The use of the phrase ‘at the forefront of performance' does not imply the best of all products in the marketplace for performance, but simply means, compared with other products with a significant market share reflecting performance, it is amongst the leading products in terms of performance relating to weight gain.

For these reasons the Committee decided there was no breach of the Code of Practice.

~ ~ ~

The Committee proceeded to consider what action it should impose, and what should be done in this case as regards charges.

The Committee decided unanimously that:-

(A) Given the Respondent’s immediate action once it became aware of its error on receiving the complaint from the Complainant, in ceasing the promotion and distribution of the brochure, withdrawing it from circulation, destroying stocks and having given its assurance to the Complainant that such erroneous promotion would not be repeated, no further sanctions or requirements would be imposed by the Committee pursuant to Rule 15 (i) (a), as the promotion in question had been discontinued, relying on the assurance given by the Respondent that the erroneous promotions would not be repeated. The Respondent is, however, asked to note that a breach of that assurance could constitute conduct which could be reported to the Board of NOAH under Rule 17.

(B) The Committee had no discretion given to it as regards enforcement of Rule 15(v). Accordingly, with considerable reluctance in the circumstances of this case, the Committee requires that the Respondent, given its breach of the Code in relation to Item One, will pay the £3,000 plus VAT charge for that item. The Committee, however, expressed the view that the Rules need to be changed to give the Committee discretion, as regards imposing this charge in circumstances where the Respondent from the outset of a complaint being made, accepts it is in breach and takes appropriate action.

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Case No. 280/06/10 : Merial Animal Health/ Boehringer Ingelheim: Metacam® Promotion

This case involved the use of the word "unstoppable" as a strap line in promotion by the Respondent, Boehringer Ingelheim, firstly in a competition card distributed at the BSAVA Conference, and in a two page advertisement in the Veterinary Times (Volume 40, Number 15) for its product Metacam®. The Complainant (Merial Animal Health) maintained that this message could mislead, in that it inferred that, for example, treatment with Metacam® could not be stopped, contrary to clause 4.5 of the Code of Practice and was all embracing and thus a superlative, contrary to clause 5.2 of the Code of Practice.

Clauses 4.5 and 5.2 are recited below:-

4.5 All information included in promotional material must be capable of substantiation and substantiation must be provided within 5 working days unless there are genuine extenuating circumstances requiring a short extension. In that event, an explanation must be supplied within 5 days with an estimate of the time in which substantiation will be supplied.

Such substantiation need not be provided, however, in relation to the validity of indications approved in the current marketing authorisation.

5.2 Exaggerated claims must not be made and all-embracing claims and superlatives avoided. Claims must not imply that an animal medicine, or an active ingredient, has some special merit, quality or property unless this can be substantiated.

The Respondent's written response was that the target audience were veterinary surgeons, who would not be misled by what was clearly a strap line, referable to the company's brand, rather than the product; and that it was not a superlative in that it did not suggest a special quality superior to other products, in that other products could also be "unstoppable".

The representatives of the parties were invited to the meeting.

The Complainant’s representative maintained "unstoppable" was a superlative, whether or not the product or brand was unstoppable, in that it implied a special merit over other products or brands. In any event, it was an all encompassing strap line. He produced statistics indicating in his view that in the canine, oral delivery, arthritic treatment market the product and brand was in decline. Further, any veterinary product can be stopped. Accordingly, even by reference to its use as a strap line directed to the brand, the statement or message is simply untrue and it therefore could not be substantiated. As regards to the formal response of the Respondent, he agreed that readership was directed to veterinary surgeons and one could generally expect such a readership not to be misled by such a strap line, but suggested that it could not be said that it was inconceivable that there might be misconception. As regards the use of strap lines referable to a brand, they were capable of providing a very powerful message. He gave examples of such use, such as the Nike shoe: "just do it ". He was closely questioned by the Chairman and by members as to whether this was an example, disclosing a characteristic of the Nike product or of the manufacturer's brand, and he suggested that it was potentially a bit of both.

The Respondent’s representative emphasised the use of the term and its placement within the advertising; that is to say immediately under the brand/product Metacam®, maintaining it was a branding item and suggested it was a mere strap line, which did not imply any technical claim or benefit. It was suggested that clause 5.2 relates to claims and that a strap line such as this was mere marketing "puff", that they were perceived as such, and gave a number of examples within the industry:-

The Respondent’s representative argued that veterinary surgeons were not misled technically by sales "hype" and produced some marketing research data which her company had established in the context of choosing a brand strap line, which revolved around continuation, like of use of the product, warm feeling, and aspiration, which all transcended from "unstoppable" within the context used, but did not in any way persuade such a readership of any technical advantage or benefit. She disputed the statistics supplied by the Complainant justified an argument to suggest a lack of growth because the sample taken had been limited to an insufficient period of examination. She also gave some visual examples utilised by her company to give the impression of arthritic freedom in cats, which again, whilst drawing attention, would not be, and had not been, objected to as implying any technical merit, and suggested the use of the term “unstoppable” in that context was no different.

After the parties had left the meeting, the Committee entered into further discussion.

In relation to the use of the word “unstoppable” as a strap line as used by the Respondent, the Committee took into account the following facts and matters:-

1. Strap lines, even if directed to the brand or Company, rather than the product, can and usually will constitute “promotion” as defined in Clause 1.1 of the Code, as their purpose will be to encourage: “the prescribing, supply or use of the company’s products”. Thus it is possible for a strap line to be in breach of the Code, which will be judged on its merit on the facts of each case.

2. The promotion in this case was not directed to and would not generally be seen by pet owners, or other end users and general members of the public, but was directed to veterinary surgeons.

3. Such readership, as was acknowledged by the Complainant, would generally be well able and qualified not to be deceived or misled by self evident strap lines, even if it can never be said that the possibility of deception or misconception is inconceivable.

Accordingly, on the facts of this case, the term “unstoppable” in the Committee’s view, in the context and use of the promotion in question, was not a superlative nor did it imply any special merit, quality or property of the Respondent’s product Metacam®. Further, it would be seen by its readership as a strap line which did not and was not intended to convey any information about a specific characteristic about that product. The promotion was considered by the Committee to be little different from many other strap lines used in the industry and by members for the purposes of promoting products of the promoter generally, and which, within the context used here, was acceptable promotion by reference to the Code.

Accordingly, the Committee’s unanimous decision was that there was no breach of either of Clauses 4.5 or 5.2.

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