Précis of Committee meetings held in 2006 for Circulation to the Veterinary Press
- 248. Pfizer Animal Health / Schering-Plough Animal Health regarding advertisements and brochures for Nuflor Injectable Solution
- 249. Arnolds Veterinary Products / Janssen Animal Health regarding Danilon Equidos advertisement
- 250. Pfizer Animal Health / Schering-Plough Animal Health regarding Nuflor Injectable Solution MIC study vs Tulathromycin (Draxxin: Pfizer)
- 251. Merial Animal Health Limited / Novartis Animal Health Limited – Stronghold Promotions
- 253. Merial Animal Health / Bayer Animal Health – Prague 2006 Offer
- 254. Boehringer-Ingelheim / Pfizer Animal Health – Rimadyl Palatable Tablets
- 255. Intervet / Schering-Plough Animal Health – Cepravin Dry Cow
- 257. Intervet / Merial Animal Health – ProteqFlu
Case No. 248 – Pfizer Animal Health / Schering-Plough Animal Health regarding advertisements and brochures for Nuflor Injectable Solution
This three item case, involved Schering-Plough’s product NUFLOR Injectable Solution, in which respect it was alleged by the Complainant, that the promotions were in breach of Code of Practice Clause 4.8 [promotion must not be inconsistent with the SPC, except that a veterinary surgeon or other suitable qualified person employed or engaged by a participating company may in appropriate circumstances give information about off-SPC use in response to a technical enquiry from another veterinary surgeon].
The three items of promotion which complaint were made:-
- “Efficacy of Nuflor in the treatment of BRD where M.bovis is isolated”;
- “Nuflor is effective against M.bovis” (Nuflor technical bulletin No. 2.); and
- “Acts fast on a broad spectrum of pathogens including ….M.bovis”.
The argument of the Complainant was that the NUFLOR SPC states under indication for use “Diseases caused by florfenicol susceptible bacteria. Therapeutic treatment of respiratory tract infections in cattle due to M. haemolytica, P. multocida and H. somnus.” (on the basis that M.haemolytica is Mannheimia – a bacteria). It was accepted that NUFLOR is indicated for the treatment of bovine respiratory disease due to these three bacteria. However, it was suggested that the SPC does not list M. bovis under indications for use, or ‘Pharmacodynamic Properties’. It was argued that Mycoplasmas were not a sub-set of bacteria and therefore not covered by the generic statement relating to bacteria on an SPC.
The Respondent’s presented independent modern scientific data to the committee that illustrated (or proved) that Mycoplasma bovis was considered a form of mollicutes (the class name of degenerate bacteria lacking a cell wall) and was therefore a bacterium and consequently the promotional claims made were not inconsistent with the SPC In the Respondent’s view, the SPC did not isolate M. bovis as lacking an indication, but was inclusive and in that regard, the specific reference to BRD which simply gives a list commencing with the word “including”, indicates that there must be a wider family of bacteria not specifically referred to within the SPC, but not excluded within the indication either.
In the event, the unanimous decision of the Committee was:
The Committee considered, based on both the evidence presented by the respondent and the understanding of individual members, that Mycoplasma bovis was a bacterium, or at least had not been proved not to be a bacterium, and therefore the promotion complained of was not inconsistent with the statement in the SPC that Nuflor was indicated for use in respect of “diseases caused by florfenicol susceptible bacteria”. Accordingly the Committee found no breach of clause 4.8.
This two item case involved an advertisement for Janssen Animal Health’s DANILON® EQUIDOS product which appeared in the 18 August and 8 September 2005 editions of Horse and Hound, and also issue of 274 of ‘Your Horse’. The allegation was that this advertisement was in breach of Clause 4.3 of the Code. [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].
Under a heading “DANILON® is a next generation prodrug ‘bute’ that’s kinder to the stomach and very palatable”, there were the three following paragraphs:
- “Its unique formulation depends upon the liver to convert it into ‘bute’. This has two distinct advantages.
- Firstly, it carries a greatly reduced risk of stomach ulcers, a well-known consequence of all non-steroidal anti-inflammatories. These ulcers, of course, affect horses’ health and performance.
- Secondly, it’s incredibly palatable. I proved that by trialling it on my old hunter, Hannah, who was notorious for rejecting traditional ‘butes’.”
The advertisement goes on to indicate that the source of the promotional words is one “George Young MRCVS, Bearl Farm Veterinary Clinic, Bywell, Stocksfield”. The two points of complaint identified, referable to the above promotion, is stated by the Complainant to be as follows:-
1) It was argued that the content of paragraph 2 of the promotion, was highly misleading, because the reader of the advertisement would immediately associate the two claimed benefits of “greatly reduced risk of stomach ulcers” and “incredible palatability” to be a comparison against the two other licensed POM of Equipalazone Powders and Prodynam, the traditional products.
2) Secondly, it was argued that the palatability comment in paragraph 3, did not constitute a statistically relevant trial as it involved only one horse. It was emphasised that anecdotal evidence is insufficient and a properly clinically proven fact is necessary, particularly if the promotion is, as was the case here, targeted at a consumer where the audience is less informed and more likely to be misled.
The unanimous decision of the Committee was as follows:
1. The Committee considered that the statement “it carries a greatly reduced risk of stomach ulcers, a well known consequence of all non-steroidal anti-inflammatories” was not accurate or balanced since the SPC for Danilon Equidos merely states “low ulcerogenic potential” and the Respondent had no data to show a greatly reduced rate of ulcers compared to Equipalazone and Prodynam. Accordingly the Committee found a breach of clause 4.3.
2. The Committee considered that the statement “it’s incredibly palatable. I proved that by trying it on my old hunter, Hannah, who was notorious for rejecting traditional ‘butes'” was not accurate or balanced since the SPC contains no statement regarding palatability and the Respondent had no evidence to support a claim to improved palatability compared to other products other than the anecdote quoted. Accordingly the Committee found a breach of clause 4.3.
250. Pfizer Animal Health / Schering-Plough Animal Health Nuflor Injectable Solution MIC study vs Tulathromycin (Draxxin: Pfizer)
This one item case involved a complaint concerning the Respondent’s promotion of a Minimum Inhibitory Concentration sensitivity trial which compared NUFLOR and tulathromycin (Draxxin) against Histophilus somni. It was alleged that in the context of the claim within the study, which apparently demonstrated that 26% of H. somni isolates were resistant to tulathromycin, constituted a breach of Clauses 4.2, 4.3 and 5.5 of the NOAH Code of Practice, in that the claim did not reflect current scientific opinion, was not accurate and did mislead and that it constituted a comparison of products which were not factual or fair.
The essential point of issue, was that it was argued that trials of this nature involved a key component that standard quality control (QC) strains should be used under strictly applied conditions, and that if the results of the standard QC strain are outside that expected, the results from the field strains (under investigation), have to be considered invalid. In the context of testing field strains of H. somni, it is important that they are grown using special culture medium and test conditions, in particular a CO2 enriched environment. The Complainant alleged that the methodology of laboratory testing used was not in strict accordance with the QC guidelines. This, it was argued by the Complainant, rendered the trial unsatisfactory and, thereby, the promotion in breach of the Code of Practice as alleged.
The Respondent’s Representatives produced the results of a further trial, which was carried out by, and certified by, the same laboratory as the original one – The Regional Veterinary Diagnostic Laboratory of Ille et Vilaine in Rennes, to validate the original test, and to support their argument that the original trial was not rendered unsatisfactory by the failure to include H. somni ATCC700025. The Respondent also provided reports of the various quality control procedures utilised in both the original and new tests. It was noted, however, that the Complainant would not have had sight of these repeated tests.
The Committee were asked to consider whether the absence of the H. somni ATCC700025 control invalidated the results and conclusions of the original laboratory study. After discussion it was clear that the unanimous decision of the Committee was that:
The Committee considered that it had not been proved that the study in question had not employed adequate quality control procedures. Accordingly the Committee found no breach of clause 4.2, 4.3 or 5.5.
This case involved the extension to the definition of promotion in Code of Practice Clause 1.1 and responses to alleged technical enquiries. The Complainant, Merial Animal Health Limited alleged the promotion of the concurrent use of Novartis Animal Health’s Milbemax product with Pfizer Animal Health’s Stronghold product, constituted a breach of Code of Practice Clauses 4.2, 4.3, 4.6, 4.7 and 5.1.
It was considered that the primary issue revolved around Clause 4.7 in that “Promotion must not be inconsistent with the SPC, except that a veterinary surgeon or other suitably qualified person employed or engaged by a participating company, may, in appropriate circumstances, give information about off-SPC use in response to a technical enquiry from another veterinary surgeon.”
The 2005 Data Sheet contained the wording referable to the “Precautions for use” of the product, being the basis upon which the complaint was raised, namely “During the treatment with Milbemax, no other macrocyclic lactone should be administered”. The 2006 Data Sheet has the same words under the heading ‘Further information’. This warning was similarly contained in the SPC.
The sample letter in question appeared to be possibly a standard form of letter, although it was stated, by the Respondent, to be used in response to questions. The question was stated to ‘often be asked’. The heavily worded disclaimer at the bottom of the page, indicated that this was “not a legally binding statement”. There were two paragraphs which appeared to be directed to different situations. The first: “The half life for Milbemax is 1- 4 days, so our opinion is that blood levels should be negligible by one week after dosing” was not necessarily directed to concurrent use, but could easily involve a question of when Milbemax can be administered when another macrocyclic lactone is known to have been administered previously. The second “Novartis has conducted studies with adult dogs and kittens, giving Milbemax and selamectin together at peak levels of each product. No adverse effects occurred in these studies which Novartis could attribute to either synergistic or potentiating effect of the two products” seemed definitely to be directed to concurrent use.
It was alleged, by the Respondent, that the critical issue in determining safe periods within to administer their product, when other products may have been used in treatment, was the blood level. Other treatments may well still be present in the animals fur, from topically applied treatments, but what mattered in terms of danger to the animal, was whether there were still traces of the previous treatment in the bloodstream of the animal, and graphs were shown which indicated, so far as the Respondent was concerned, that within 3 – 4 days all traces would have disappeared. Accordingly, to be absolutely safe, the Respondent advised a gap of one week between treatments.
It was alleged that the letter, that was the subject matter of the complaint, the letter that was supplied in the response, together with a third sample that was provided in the presentation, were all attempts to respond to technical enquiries, in that whilst the form of the letter was largely the same, there had been re-use by copying and pasting previous responses, and every response was a specific response, individually tailored to the enquiry that was being made. It was said that the number of enquiries was 4 or 5 , which could have been written or verbal, and it was always veterinary surgeons who raised the queries. The Respondent was unable to say in relation to the 4 or 5 enquiries whether these involved concurrent use or use following previous treatment of another product. The Respondent was aware of the specific problems concerning treatment of Collies, but in the Respondent’s view, this was not a problem when using their own product.
As regard the distinction between the two paragraphs, one appearing to be dealing with the timescale within which the product could be administered to an animal which had been treated with another product previously, whereas the second involving concurrent use, the Respondent maintained that the significant factor was the time within which previous treatment would remain in the blood, and that the Respondent always advised a seven day period was appropriate, but it was agreed that this second paragraph indicated concurrent use, and accepted it was possibly an error to describe or refer to concurrent use, contrary to the SPC’s warning. It was intended to be a safety valve or a declaration of comfort to the users, and not deliberately to promote concurrent use. It was not accepted by the Respondent that the advice given was contrary to the Cascade principles and therefore encouraging veterinary surgeons to commit an illegal act.
The unanimous decision of the Code of Practice Committee was:
- the example letter dated 24 November 2005 complained of constituted promotion of Milbemax inconsistent with the SPC since it would or might encourage prescribing or use of Milbemax concurrently with selamectin; and
- it was not appropriate to provide information about concurrent administration of Milbemax and selamectin when (a) the provision of such information was not necessarily required to answer the technical enquiry in question, (b) the letter failed to state that administration of the two products concurrently would be contrary to the Cascade and (c) the letter failed to state that Novartis did not encourage concurrent administration of the two products.
Accordingly the Committee found a breach of clause 4.7. In view of this finding the Committee did not consider it necessary to rule upon the allegations that the letter was also in breach of clauses 4.2, 4.3, 4.6 or 5.1.
This case, which arose shortly after the alteration to Code of Practice Rule 18 governing gifts and hospitality, was brought by Merial Animal Health Limited against the Respondent, Bayer plc, referable to the forthcoming WSAVA Congress in Prague in October 2006, in which the Respondent was offering to take recipients to Prague “to coincide” with the 31st WSAVA Congress. Such offer included the costs being paid, by the Respondent, of return flights from Stansted, Edinburgh, Manchester or Birmingham with Czech Airlines, departing Tuesday 10 October 2006 and returning Sunday 15 October 2006 (with the ability for the return date to be extended), five nights bed and breakfast accommodation in the 5 star hotel, Corinthian Towers, four hospitality evenings and an all-day sight-seeing Prague tour. Attached to the offer leaflet was an order form for some 40 different products of the Respondent and in the wording of the pamphlet, ‘offer’ was paragraphed under the heading ‘secure your place now’; in order to secure your place, orders must be delivered by 30 June 2006 latest. Orders may be taken as two deliveries within a three month period before the 30 June 2006 …… Bayer reserves the right to invoice the practice for up to £1500 should any part of the order not be taken by 30 June 2006.” Additionally there was a note “this trip, or elements of it, may be considered by the tax authorities as a benefit in kind and therefore liable to taxation and insurance. Bayer will provide recipient details, if required to do so, by the tax authorities. If you require any advice on this issue, you should contact your tax advisor”. Finally, in a white on red background box, it was specifically stated on the order form for product “registration for WSAVA Congress is not included in the offer, due to the varied individual interests and requirements by the participants …..”
Code of Practice Clause 18 comprises two parts as follows:
18.1 Sponsorship, gifts and hospitality shall not be such as to bring discredit upon, or reduce confidence in, the industry.
18.2 No gift shall be offered or issued with the sale or purchase of an animal medicine, other than price or product itself, unless it is directly related to the correct use, administration or disposal of that medicine, by the person to whom it is offered, or the intended end user of the medicine.
The Respondent confirmed that the decision to provide the hospitality had been taken prior to the change in Rules, repeating an arrangement provided in previous years and the Respondent had been asked, by those that attended before, if this would be continued. It was explained that it was not possible, in practical terms, to arrange for registration, which was the reason for not including that, but that this offer was only made to large purchasers of goods who were already customers on the Respondent’s priority scheme. It was not supplied generally, or to non-customers. The purchasers who almost certainly would continue to purchase the Respondent’s products. The company felt it appropriate to charge £1500 if, however, such customers having taken advantage of the offer, then took their custom elsewhere. Moreover, during the course of the hospitality evenings, there were training sessions provided.
In answer to the query “how could the hospitality gift be directly related to the correct use, administration or disposal of ‘that medicine’”? (given that the form had some 40 different products), it was said that the company was represented at the WSAVA and also all the benefits of the trip were included on the WSAVA website. These extra benefits were nothing to do, specifically, with the company’s offer. They were part of the Congress itself.
The unanimous decision of the Committee was that the offer was a gift offered with the purchase of animal medicines which did not consist of price or product itself and which was not directly related to the correct use, administration or disposal of those medicines. Accordingly the Committee found a breach of clause 18.2.
It was not felt necessary to consider whether or not there had been a breach of 18.1, given the decision that there had been a clear breach of 18.2.
This one item case brought by the Complainant, Boehringer Ingelheim Limited, regarded the promotional use of the words “….. stimulates cartilage regeneration” in relation to Pfizer’s product Rimadyl, on the grounds that this was unsubstantiated by reference to the SPC and therefore misleading contrary to Clause 4.3 of the Code. The advertisement appeared in the 3rd July 2006 issue of the Veterinary Times.
Clause 4.3 of the Code provides that “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”.
It was decided that the Complainant’s complaint that the Respondent had by its use of this advertisement, broken an earlier voluntary undertaking, was not substantiated by the facts. These were that that voluntary undertaking had been quite explicitly limited to the earlier use of wording “The new licence variations now states that Rimadyl stimulates cartilage regeneration” which form of wording was not used in the July 3rd advertisement.
The precise words of the SPC in question were identified as being contained under section 4, Pharmacological Properties, Subsection 4.1 ‘Mechanism for Actions’:
“In addition, therapeutic concentrations of Carprofen have been demonstrated (in vitro) to increase proteoglycan synthesis in chondrocytes from canine arthritic cartilage. Stimulation of proteoglycan synthesis will narrow the difference between the rate of degeneration and regeneration of cartilage matrix resulting in a slowing of the progression of cartilage loss”.
It was explained to the Respondent’s Representatives that the Committee had two questions:
- Firstly, the SPC seems to make a very specific statement and in particular appeared to limit the licensing indication to in vitro circumstances. How was it felt that the Respondent was entitled to rely on the SPC to demonstrate “in vivo” circumstances? The response to this was that, the words contained in the second part of the relevant section in the SPC, could only relate to in vivo circumstances. Further, under closer questioning, the Representatives indicated that each of the sections were supported by different studies.
- Secondly it was suggested that the exact language of the SPC does not actually reflect the words “stimulates cartilage regeneration”. If that is what the SPC is meant to mean, why does it not say it as such? The Representatives answer was that whilst that may not be the exact words, it is the only meaning that can be given to those words. It was stated that the process of securing authorisation and the wording in an SPC, involves a very specific and clear cut technical process. The issues were managed by technicians and not marketers. Nevertheless, what was now stated in the promotion, in the Representatives view, was entirely consistent with what, in effect, the SPC was stating and that accordingly they went through the process step by step to justify their view that it was consistent.
The Representatives put forward a published paper; “Carprofen Simultaneously Reduces Progression of Morphological Changes in Cartilage and Subchondral Bone in Experimental Dog Osteoarthritis” (Pelletier et al 10 April 2000, revised 4 July 2000). The Representatives highlighted firstly part of the heading; “Carprofen Simultaneously Reduces Progression of Morphological Changes in Cartilage” and in the final paragraph, the words “carprofen reduces the progression of early cartilage loss/degradation”.
The Chairman acknowledged the usefulness of the publication, but commented that it would have been helpful if this had been supplied earlier, both to the Complainant in inter-company discussions, and certainly in terms of the Representatives’ formal reply. The Respondents stated, at this point, that the Complainant had not communicated with them regarding the second revised advert, only the first one that they then changed. They apologised for not including it in their formal response to the second complaint, but the first they heard of the second complaint was when they were notified by the Secretary of the formal complaint.
The Respondent’s representatives argued that in the case of arthritic cartilage the rate of regeneration is less than the rate of degeneration and leads to progressive loss of cartilage. It was maintained that Rimadyl increases the rate of regeneration by comparison to the rate of degeneration, thereby slowing the progression of cartilage loss. It was argued that this was the meaning of the words in the SPC forming the second part of the section headed “Mechanism of Action” which stated “Stimulation of proteoglycan synthesis will narrow the difference between progression of cartilage loss”. It was acknowledged that Rimadyl had no impact on the rate of degeneration of canine arthritic cartilage and reference was made to Benton et al (1977 – at page 209) “stimulation of new GAG synthesis was not mirrored by any significant changes in the rate of GAG release from explants into the culture medium, an assay that serves as a measure of the rate of cartilage proteoglycan matrix degradation”. It was argued that it was reasonable in these circumstances to suggest that Rimadyl “stimulates cartilage regeneration”. However, it was suggested that for the purpose of clarification to the normal reader, the statement “stimulates cartilage regeneration” which is contained and supported by the SPC, should be qualified to indicate the effect of this mode of action, so that “Rimadyl stimulates cartilage regeneration, thereby slowing the progression of cartilage loss”. Effectively, the form of words as used in the advertisement in dispute.
The Chairman acknowledged that the technical language of an SPC does not make good advertising copy, and that inevitably, more accessible language would be needed. But nevertheless, it is the job of the Code of Practice Committee to see that that process does not give a misleading view. The Respondent’s Representatives agreed, pointing out their willingness to remove wording from earlier advertisements which arguably could be criticised.
The consensus of the Committee was that what had been unclear in most of the Members’ minds previously, had been considerably helped by the ‘Pelletier’ article and by the presentation by the Representatives. It was accepted that the language contained in the SPC is sometimes inappropriate for promotional use, and that in these circumstances the net effect was backed up by the technology in question, and was thereby not misleading. It was felt that the presentation had made it clear that the promotional words were a genuine and sincere attempt to get a message across correctly.
The Committee considered that the statement “The new licence variation now demonstrates that Rimadyl also stimulates cartilage regeneration, thereby slowing the progression of cartilage loss” was a fair summary of the SPC. Accordingly the Committee found that there was no breach of clause 4.3.
This one item case involved a complaint from Intervet UK Limited, relating to Schering-Plough Animal Health’s promotional activities for Cepravin Dry Cow, whereby it was alleged that the statement “……it’s the only dry cow tube licensed to reduce cell counts” is in breach of 4.3 in that “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.” The above statement appeared in both a leaflet and detailer (SPOO1271 (0406)) and the full sentence on the leaflet is: “With up to 10 weeks broad spectrum cover against the major mastitis causing bacteria, it’s the only dry cow tube licensed to reduce cell counts”.
Concern was expressed by members of the Committee that the advertisement (as opposed to the detailer) would be read by ‘farmer’ readers. Mastitis involves a whole range of bacteria, not just Streptococcus uberis. But the SPC only provides an indication in relation to Streptococcus uberis.
The precise words of the SPC in question contained under section 4 Pharmacologic Properties, subsection Pharmacodynamics are:
“……. Effective levels of cefalonium are maintained in most quarters for up 10 weeks after infusion of CEPRAVIN Dry Cow. Cattle treated with CEPRAVIN Dry Cow have a lower incidence of Streptococcus uberis infection during the dry period and the immediate post-calving period, with accompanying lower somatic cell counts”.
The Respondent’s Representatives drew on the full context of the words, the subject of the complaint, and it was suggested to them that that context could create greater misunderstanding, given that Streptococcus uberis is not the only cause of mastitis. The Representatives maintained that that was a major cause of mastitis. Further, they maintained that was an absolutely true statement to state that the product is the only dry cow tube licensed to reduce cell counts. Under queries being raised, the Representatives agreed that all dry cow tube products reduced cell counts, but their product was the only one that was specifically licensed. Queries referable to the detailer were raised, in that it provided specific detail as to the reduction in cell counts. The Representatives emphasised that they were relying entirely on the reference on the SPC, and that there was no intention to mislead. It was acknowledged that a farmer would not necessarily see the detailer. However, the Representatives pointed out that they always emphasised the need for appropriate reference to be made to expert veterinary opinion.
The Representatives also drew attention to one of the points that had been raised in the formal response, namely, that the wording had been used since 2002. The Chairman sought clarification as to when the advertisement (as opposed to the detailer) had been first produced. The Representatives were unable to clarify if the advertisement (as opposed to the detailer) had been used, prior to 2006.
The Chairman felt that in view of the question of the wording having been in existence since 2002, the Committee should consider the implication of Rule 7 which gave a right to the Committee to dismiss an application if it was at least two years after the event first giving rise to the complaint. The Chairman emphasised that even in those circumstances, the Committee must consider that it is fair to dismiss such an application. In this case the Representatives had been unable to confirm what form the promotion had been utilised in previous years and in particular whether the data contained in the detailer would have accompanied that promotion. It was for the Respondent to justify its argument and in the light of that the Committee decided that it would be inappropriate to apply Rule 7.
The Committee considered that the statement “it’s the only dry cow tube licensed to reduce cell counts”, without making it clear that the SPC refers only to lower cell counts accompanying Streptococcus uberis infection, was misleading. Accordingly, the Committee found that there was a breach of clause 4.3.
The complaint from Intervet UK Limited relates to Merial Animal Health’s promotional activities for ProteqFlu and constituted four issues.
It was alleged that in printed material, press releases and seminars the Respondent was promoting information which was inconsistent with the SPC, contrary to Code of Practice Clause 4.7, by way of inclusion of a trial claiming efficacy after one vaccination, when the SPC states that protection is provided two weeks after the second vaccination. The complaint centred on the following four items (2 in bullet point 3):
- Page 11 of the brochure titled “Equine Flu vaccines. Are you seeing the whole picture?” included the words “Equine influenza vaccines typically confer protection 2 weeks after the second dose. However, this study demonstrates that ProteqFlu induced rapid protection following a single dose which may be of significant value in the face of an outbreak”. The Complainant maintained that this statement makes the claim that the trial demonstrates an onset of protection (not afforded by other vaccines) which is inconsistent with the ProteqFlu SPC, and then further promotes this by stating that this protection may be of value to the user.
- Page 14 of the brochure titled “Proceedings of the Merial Symposium on Equine Infectious Diseases. Marrakech 24th January 2006” states “The recombinant influenza vaccine induced a rapid onset of immunity with a single administration, which may be of significant value in the face of an influenza outbreak”. The Complainant maintained that this vaccine (known to be ProteqFlu, as described on page 12) promotes single dose use contrary to the SPC. This brochure is a Merial production and clearly promotional, as evidenced by the ProteqFlu branding throughout (pages 2, 17, 30 and 31).
- Press Release UK Vet Vol 11 No 8 November 2006 states “ProteqFlu is the only EIV vaccine proven to provide rapid protection after a single dose”, “…our study remarkably demonstrates protection following a single dose” and “Since traditional equine flu vaccines typically confer protection two weeks after the second dose….evidence of onset of immunity after a single dose is of significant value in the face of an outbreak”, which the Complainant maintained repeated the same claim, contrary to the SPC.
Clause 4.7 requires that “promotion must not be inconsistent with the SPC, except that …….” (the exception not being material to the case).
The Complainant alleged that they had challenged the Respondent repeatedly over the use of this trial and on previous occasions the Respondent had agreed to withdraw the material, but has since proceeded to use this trial again with a change of promotional material. The original wording was understood to be “In a recent challenge study, protection against Newmarket 5/03 was confirmed after a single dose”.
The precise words of the SPC are contained under section 4, Clinical Particulars, subsection 4.2 ‘Indications for use, specifying the target species:-
“Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection. Onset of immunity: 14 days after primary vaccination course. Duration of immunity induced by the vaccination scheme: 5 months after primary vaccination course and 1 year after the third vaccination.”
It was noted that the complaint not only referred to the promotions being in breach of 4.7 of the Code of Practice, but also alleged they were contrary to Regulation 10(1) of the Veterinary Medicines Regulation (Order 2006), which came into force on 1st October 2006 and which provided that it was an offence to advertise medicinal claims not in the SPC.
Committee discussions included equine vaccines and horse racing (including all other events operating under Jockey Club rules) where owners, trainers and veterinary surgeons have to comply with Jockey Club Rules, which themselves specified two doses.
The Respondent’s Representatives emphasised that what the promotions were endeavouring to do was to supply important information to Veterinary Surgeons, to whom the promotions were directed, that in the circumstances of an equine outbreak of flu, speed of protection was essential and that whilst, to provide guaranteed immunity the full course of two vaccinations as specified in the SPC would be required, nevertheless, the trial referred to in the promotions indicated that ProteqFlu, contrary to inactive vaccines, had been shown to provide rapid protection following a single dose. They emphasised that this was something which was critically important and had been shown to be of particular relevance following a recent outbreak of flu in the Newmarket area which had caused very serious difficulties. The importance of rapid protection could not be underestimated in those circumstances.
The Representatives drew attention to the Jockey Club Rules which required two doses anyway. They drew attention to the fact that the promotion only appears within technical brochures and that it was promotion directed to veterinary surgeons and not the general public, using the term ‘may’ throughout, thus indicating its intention was informative only. The Respondent’s sales representatives had been very strictly instructed as to the information that could be given which was to recite the terms of the SPC, and in the event of queries outside the licensed indications of the SPC, reference had to be made to the technical department for advice. The Representatives emphasised that in their view the Respondent had followed the voluntary undertaking that had been previously given “to the letter”.
The Representatives were questioned as to whether the promotion did not imply their product had an advantage over other inactive vaccines by suggesting rapid protection after a single dose, which was treatment which was inconsistent with the SPC indication; the apparent highlighting of this perceived advantage and the inter-changeability within the brochures and advertisements of the terms “protection”, “immunity” and “onset of immunity”. The Representatives argued that the promotions were providing valuable information to Veterinary Surgeons, within the context of an outbreak, not routine or standard use.
The Committee considered (unanimously with regard to items 1, 3 and 4 and with one dissenting vote with regard to item 2) that all four items complained of were inconsistent with the SPC because they amounted to a claim that ProteqFlu and ProteqFlu-Te gave immunity after a single dose whereas the SPC states that onset of immunity is 14 days after the primary vaccination course of two doses. Accordingly the Committee found that all four items were in breach of clause 4.7.