Précis of Committee meetings held in 2009
- 271. Merial Animal Health – Boehringer Ingelheim Ltd: Metacam promotion
- 272. Complaint by Lambert Leonard & May LLP against Pfizer Animal Health and 273. Complaint by Intervet/Schering-Plough against Pfizer Animal Health: both cases involved the promotion of Spirovac and Pregsure
- 275. Boehringer Ingelheim Limited/Intervet/Schering-Plough Animal Health Promotional activities: Porcilis PCV
- 276. Merial Animal Health/Virbac Limited: Promotion of Effipro
- 277. Merial Animal Health/Pfizer Animal Health: Promotion of Rimadyl Cattle
- 278. Boeringer Ingelheim/Pfizer Animal Health: Promotion of Rimadyl Cattle
This one item case considered the promotion of Metacam® by the Respondent, Boehringer Ingelheim, which consisted of a fax-back form distributed to veterinary practices, inviting a return indicating the number of prescriptions for Metacam® that had been given previously, in response to which the Respondent would provide a free gift, comprising a model feline elbow joint or hip joint or both such models, depending on the number of prescriptions given.
The Complainant considered that this promotion was in breach of Clause 18.2 of the Code of Practice, which reads:
“No gift shall be offered or issued with the sale or purchase or for the prescription 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 considered that the provision of the gift had a beneficial educational consequence and was necessary or of assistance to veterinary surgeons in helping their diagnosis, and bringing more clearly to their attention the prevalence of arthritic changes, particularly in cats. As such, they felt the gift came within the exceptions permitted for gifts, by being directly related to the use of the medicine.
The representatives for the Complainant and the Respondent were Ms Claire Parry-Baggott (Merial Animal Health), Mr Jonathan Hill (Merial Animal Health) and Dr Sue Jones (Boehringer Ingelheim). Their views were expressed as indicated above. The Respondent’s representative emphasised that the purpose of providing the model was directly related to the use of Metacam®, and that this was particularly necessary in order to draw attention to the significant extent of arthritis taking place in cats, which had not been adequately recognised by pet owners. The Complainant’s representatives felt that the promotion was in clear breach of the terms of Clause 18.2 in that it could not be stated that the provision of the model gifts constituted anything that was referable to the direct use or administration of the medicine. They also considered that it was very important that the rules governing gifts, as reflected by Clause 18.2, should be properly enforced in that retention of self-regulation by the industry was vitally important.
The Committee considered that the intention behind the rule was to ensure that veterinary surgeons should not be distracted by gifts or inducements from making what they would otherwise consider to be the appropriate diagnosis and prescription of medicine for any given case. Whether provision of educational aids may or may not be desirable was irrelevant, because at the present time such provision as a gift was not permitted by the Rule. It was considered that the phrase “that medicine” should really relate to the brand of medicine in question, or possibly the chemical or medical compound involved, and not specifically the actual medicine prescribed; nevertheless, the Chairman considered that a respondent would find it a heavy evidential burden to suggest that a gift could be directly relevant in the use of the medicine if it was supplied long after the prescription had been made.
The view of the independent veterinary surgeons present was that these models were more relevant in explanations being given to the clients or pet owners consulting the veterinary surgeon, rather than any assistance being given to the veterinary surgeon. Moreover, to the extent there was any benefit given to the veterinary surgeon, it was in relation to diagnosis, and not the use or administration of the medicine. Accordingly, the relevance within the context of the Code on usefulness of such models was doubted. There was possibly even potential danger in that misuse of the models might tend to encourage unnecessary prescription of the medicine.
Some questions were asked of the Respondent’s representative by members, including one directed as to why they had simply not distributed the models without reference to prescriptions. The Respondent’s representative explained that there had been a significant cost in the manufacturing of the models which had been designed and constructed to order specifically for the purpose.
The Representatives were thanked for their comments, and released from the meeting.
The Committee’s unanimous decision was that the provision of the fax-back promotion linking the prescription of Metacam® to the right to receive a gift of a model feline elbow and/or hip joint or of both such model joints constituted a breach of Code of Practice clause 18.2 in that the gift did not “directly relate to the correct use administration or disposal of that medicine”.
The Chairman’s view was that the purpose of Clause 18.2 of the Code of Practice was to ensure that any prescription by a prescriber of a pharmaceutical for animals was not in any way influenced or induced (or perceived as influenced or induced) by the offer of gifts but was solely based upon the quality of the product and the price of the product. His view was that Clause 18.2 was intended to prevent the offering of such gifts unless it could be fairly said that for medical or health and safety reasons, the gift was required for the purpose of correctly using, administering or disposing the medicine that was prescribed.
In the present case, the gifts were concerned, at the highest, with diagnosis of an arthritic condition and not the prescription of a particular medicine. Furthermore, the fact that the gifts were provided after Metacam® would have been ingested suggests that they were not needed (and thus not directly related) for the correct use, administration or disposal of Metacam®.
All participants found in breach of th|e Code are required under Rule 15(i)(a) to give an undertaking that the practice in question (if not already discontinued) will be discontinued.
Boehringer Ingelheim signed the following undertaking on 13 February 2009:
- We acknowledge notification of the decision(s) of the Committee in Case 271/12/08 as set out in your letter of 4 February 2009.
- To be completed in all cases:
- We accept the decisions of the Committee and undertake that the practices in question (if not already discontinued) will be discontinued forthwith, and to that end, we have taken the following steps in relation to any promotion of Metacam®:
- Save as may be permitted by any future changes to the Code of Practice, not to promote Metacam® by offering model feline elbow or hip joints as gifts dependent upon the prescribing of Metacam® or any other gift (other than price or the product itself) which is not directly related to the correct use administration or disposal of that medicine.
- We hereby give an assurance that we will take all possible steps to avoid a similar breach, or breaches, of the Code occurring in the future.
30 March 2009 (for Case 271)
Case 272/04/09 : Complaint by Lambert Leonard & May LLP against Pfizer Animal Health
Case 273/05/09 : Complaint by Intervet/Schering-Plough against Pfizer Animal Health
Both cases involved the promotion of Spirovac and Pregsure.
These cases raised novel issues, both in terms of the subject matter, the fact that both cases involved the same item of complaint and for the first time (in the context of case 272), the Committee was dealing with a complaint from a non-member.
The item of complaint, common to both cases, related to the Respondent’s Pregsure/Spirovac jigsaw advertisement AH581/08, used in a direct marketing campaign to farmers.
It was alleged, by both Complainants, that the offer of a £35 cash-back, if the farmer purchased over £300 of Pregsure BVD and Spirovac from their Veterinary Surgeon, was in breach of Code of Practice Clauses 18.1 and 18.2. The Complainant in Case 272 also suggested that the promotion was in breach of Code of Practice Clauses 3, 4.6 and 17.2.. In Case 273, in addition to Clauses 18.1 and 18.2, the Complainant also suggested that the promotion was in breach of Clause 7.4 (vi).
Those clauses of the Code of Practice are recited below:-
3 Methods of promotion must never be such as to bring discredit upon, or reduce confidence in, the industry.
4.6 All information must be presented so as to maintain the respect and confidence of veterinary surgeons, pharmacists, Suitably Qualified Persons, the business user and the public, and to promote the correct use of animal medicines.
7.4(vi) Promotions for POM-V medicines aimed at people other than those legally allowed to prescribe them must include a focus on education and/or disease information.
17.2 Promotion directed to the lay user must never be such as to bring discredit upon, or reduce confidence in, the animal medicines industry or those persons permitted to prescribe such medicines to the lay user.
18.1 Sponsorship, gifts and hospitality must 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 or for the prescription 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.
It was decided, with the approval of the Representatives who were present, to deal with both cases together; identifying, however, where differences lay between the two complaints, particularly with regard to those differing Clauses of the Code of Practice in respect of which the Complainants said the Respondents were in breach, other than for Clauses 18.1 and 18.2.
The core issues the Chairman identified, in both cases, were whether the cash-back incentive constituted a breach of 18.2, because it was not referable to a sale or purchase and/or did not relate to price or product. The secondary issue was that, whatever may be the answer to the issues relating to Code of Practice Clause 18.2, did the practice of offering a discount in this manner cause or bring the industry to come into discredit or disrepute, or put the vet in an invidious position.
The Complainant in Case 272 was not represented at the meeting. The representative for the Complainant in relation to Code of Practice Case 273, Intervet/Schering-Plough was Mr Alasdair King; the Representatives for the Respondent, Pfizer Animal Health for both cases 272 and 273, were Dr Edward Ferguson and Mr Humphrey Grimmett.
Mr King representing Intervet/Schering-Plough, expressed some queries regarding the inclusion of Clause 7.4 (vi) and eventually withdrew any allegation that the promotion was in breach of that Code of Practice Clause. Accordingly the complaint thereafter was only considered in the context of a breach of Code of Practice Clauses 18.1 and/or 18.2.
The Chairman sought concentration on four particular points, which he identified as being:
i) The Complainant’s view on a £35 cash-back offer which applies once £300 worth of medicines have been prescribed and whether this constituted any real difference from a discount to a particular product at the point of sale, bearing in mind the provision in Code of Practice Clause 18.2 which gives an exception to gifts relating to “price or products”;
ii) Any difference in relation to £35 discount at the point of sale to the prescriber or dispenser of the medicines, as opposed to a cash-back to the farmer;
iii) Whether there was any difference in a promotion relating to a cash-back referable to a combination of products, as was the case here, as opposed to a discount offered in terms of a single product; and
iv) If there was no breach of Code of Practice Clause 18.2, that is to say it was a permitted gift relating to price or product, what precisely was the Complainant’s position as regards 18.1. How is it stated by the Complainant that this promotion brings discredit or reduces confidence in the industry?
Mr King, Representative of the Complainant, said that the promotion was in breach of Clause 18.1 irrespective whether or not there was a breach of 18.2. The Complainant took the view that whatever might or might not be permitted in accordance with Code of Practice Clause 18.2, it was necessary for the promotion to meet the requirements of Code of Practice Clause 18.1, that is to say it must not bring discredit upon or reduce confidence in the industry, and in his view, the promotion did bring such discredit and reduction in confidence. He questioned whether the promotion in this particular case, constituted a discount on price as opposed to a gift of money. He suggested that a discount bears a natural relationship to price, but that in this case, there was no relationship to price at all. The gift of money was given after the event and simply was based on a quantity of two different products after the price had been fixed and paid by the purchaser/prescriber, and bore no relationship to the price, if any, that would be paid by the farmer for the dispensing of that product; the amount of money gifted related to simply the quantity of one or both products. Moreover, in this case, it did not matter how much product was purchased once the qualification amount was met, that is to say, it did not matter whether the cost of the product was £300 or £1,000. If a large amount of product had been purchased, it would be a nominal sum; if the minimum sum was purchased, it was not a nominal sum and amounted to 10% of the value. It was given to the farmer, not to the purchaser/prescriber of the medicine and, therefore, in his view, was clearly a gift, not a discount based on price of the product. Such sales would go through a wholesaler, who in turn would sell to the veterinary surgery practice. The veterinary surgery practice would then charge the farmer at a given price.
The Respondent’s representatives emphasised the importance of the farmer having a complete picture of the available products and the benefit of being able to vaccinate the two products against the two diseases, Leptospira and BVD, at the same time. This was very significant and a unique improvement, bringing welfare benefit to the herd. Vaccination was a traumatic experience for the cow and there had been frequent cases of difficulties the farmers had in having to vaccinate cattle only a matter of days or very few weeks, between one vaccination and another vaccination. The difficulty in applying the second vaccination to cattle which had suffered trauma from the first vaccination was often significant. Accordingly the purpose of the promotion was to provide education to the farmers that there was now available on the market a means, in the context of these particular diseases, to vaccinate at the same time for both.
The problem (with the enormous amount of mail directed towards both veterinary surgeons and farmers) was to ensure that the farmer became aware of the benefit in question and, in the view of the Respondent, in these days it was critically important that farmers should be adequately informed as quickly as possible of the benefits that may exist. Whilst it was right that veterinary surgeons should have priority always in terms of what should or should not be advised to be administered in the best interests of the animal, the fact remained that it was farmers who would first become aware of circumstances requiring medication and vaccination and they needed to be made fully aware of available treatments.
To that end, the £35 promotion was far more directed towards drawing the attention of the farmer to the leaflet and the information contained in it, than in having any real financial benefit. In any practical sense, bearing in mind the general level of purchase, the £35 would be a relatively nominal sum. On enquiry, the representatives said that, in their view, on average, the cash-back amounted to perhaps 2% in a typical circumstance. The fixed value of the cash-back would always constitute a discount once received, but the fact that it was a fixed sum, and did not relate to quantity, emphasised the fact that it was not intended to put undue pressure on the veterinary surgeon and would not in practice do so, bearing in mind the relatively small value involved. What, however, it would do, would be to draw attention to the farmer of the benefit that was now available through the combination vaccination process. The cash-back take up was very low.
The Committee then considered the remaining Code of Practice Clauses in respect of which the Complainant in Case 272 alleged the Respondent was in breach. Insofar as Clause 17.2 was concerned, reference was made to Clause 1.4 of the Code of Practice which ensured that a farmer was not a lay user within the meaning of that Clause. As regards the other allegations, they were felt to be similar in effect to those of Clause 18.1, to which the Respondent’s previous comments had equal effect.
The decisions of the Committee were as follows:
Case 272/04/09 and Case 273/05/09
18.2 The Committee’s view is that the cash back offer of £35.00 is a gift; that this gift was issued or offered for the sale or purchase or the prescription of an animal medicine, but that it did relate to the price or products because its overall effect is to make the products cheaper to the farmer than if it were not made. It is important that competition based on cost to the farmer is not diminished.
Accordingly, the Committee considered that there was no breach of Clause 18.2.
18.1 The Committee’s view is that when a financial incentive is made to a farmer which makes the purchase of a product cheaper than if it had not been made, which incentive is not in breach of Code of Practice Clause 18.2, it will take exceptional circumstances for that incentive to be in breach of Code of Practice Clause 18.1, by bringing discredit upon or reducing confidence in the industry. On the facts of this particular case the Committee did not consider that there were exceptional circumstances. In particular, the Committee considered that, in this particular case, on the facts the cash back related to a combination of products produced by the Respondent and that the promotion was in large part intended to highlight the fact that their products Spirovac and Pregsure were the only products on the market licensed to be administered at the same time as each other. The Committee also accepted the Respondent’s assertion that the leaflet’s primary focus was the education of farmers to the availability of that combined use to counter leptospirosis and BVD, thereby minimising handling episodes and thereby improving animal welfare, and that the cash back of £35 for a volume exceeding £300 was a subsidiary purpose of the leaflet.
Accordingly, the Committee held that there was no breach of Code of Practice Clause 18.1 and also Clauses 3, 4.6 or 17.2 for the same reasons.
Additionally, in the case of Clause 17.2, the promotion to be in breach had to be directed to the lay user. By Code of Practice Clause 1.4 the term ‘lay user’ does not include a ‘business user’ and by Code of Practice Clause 1.3 ‘business user’ includes a farmer or farm manager. Accordingly, this promotion was not directed to a lay user.
It was noted that at the meeting, the Complainant formally withdrew its complaint under Code of Practice Clause 7.4 (vi) and so no decision had to be made in that regard.
Case 272/04/09 and Case 273/05/09
It was further agreed, pursuant to Clause 25 of the 19th Edition of the Code of Practice which reads:-
25 In the light of its experience of the working of the Code, the Committee may make such recommendations as it deems fit of the amendment of the provisions of the Code. Any proposal for amendment of the Code shall be forwarded to the Committee before formal adoption and any comments of the Committee shall be taken into account before the proposal is adopted.
that the whole subject of manufacturers promoting their products to end users and farmers including, in particular, informing those end users and farmers about market prices and/or making financial incentives, should be considered by the Board with a degree of urgency whether and to what extent such is in the interest of animal health and welfare.
Accordingly, the Chairman will be formally writing to the NOAH Board with the knowledge and support of the NOAH Chief Executive, Mr Philip Sketchley, for their due consideration of the wording and ambit of Rules 18.1 and 18.2.
Promotional activities: Porcilis PCV
This case involved five items of complaint by Boehringer Ingelheim Ltd. The promotional material involved was Intervet/Schering-Plough’s product: Porcilis PCV®, which was contained in a Technical Brochure and in an article in International Pig Topics (Volume 24 Number 4).
The five promotional items to which complaint was made were as follows:
A. Technical Brochure.
1. “…. and officially registered label claims were granted for… the 1 x 2 ml dose scheme…”
2. Graph entitled “Porcilis PCV once.”
3. “A single dose of Porcilis PCV “
4. “…. measured after a single vaccination.”
B. International Pig Topics
5. “Porcilis provides this with a one shot programme of 2 mls of vaccine at three weeks of age”
It was alleged that these promotional items constituted breaches of Code of Practice Clauses 4.6 and 4.7., which state:
4.6 All information must be presented so as to maintain the respect and confidence of veterinary surgeons, pharmacists, Suitably Qualified Persons, the business user and the public, and to promote the correct use of animal medicines.
4.7 Promotion must not be inconsistent with the SPC, except that a veterinary surgeon or other appropriately 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 Chairman summarised the case as relating, in the first four items to which complaint was made, to a symposium in Portugal, dealing with Porcilis PCV®, a vaccine that was not authorised in Europe for a one shot programme – the product was authorised, through the centralised procedure (via EMEA), for two shots and therefore promotion within any European member state should be consistent with the centralised SPC. He suggested that the brochure in question had been distributed clearly for promotional purposes.
The symposium had been apparently organised by the respondent’s parent company based in the Netherlands, and not a direct member of NOAH. The Respondent’s argument was in effect that they had nothing to do with either the setting up of the symposium or the content of the technical brochure. It appeared not to be a matter of dispute between the parties that the promotion in question, of a one dose regime, was off-SPC, not just in the UK but also throughout Europe. However, it appeared to be the case that certain UK delegates to the symposium had been invited by the member Respondent.
The fifth item involved an article in International Pig Topics. The complaint was the same in promoting a one shot programme for which the product was not licensed. The Respondent’s answer was that they had nothing to do with the insertion of the article, or its content, which had again been handled by the parent company.
The representative for the Complainant was Mr Allan Henderson; the representatives for the Respondent were Mr David Schofield and Dr Susan Rennie.
The Chairman sought and received confirmation from the Representatives that they had seen the exchange of letters from the Secretary and the Respondent that arose following the Respondent’s formal response, which dealt with the responsibility for inviting delegates to the symposium; planning of the promotion in International Pig Topics; and the readership of that periodical.
The Complainant’s representative emphasised that the symposium was launching the use of a product which was contrary to its SPC for the whole of Europe, to which symposium the Respondent had invited United Kingdom delegates. He queried that the Respondent would have had no prior knowledge of the content of the symposium and/or the technical brochure giving reference to a one shot programme; it was not relevant who prepared the brochure or who was responsible for the content of the symposium; all that mattered was that United Kingdom veterinary surgeons had been invited by the Respondent.
Secondly, the Complainant’s representative, in relation to the article contained in International Pig Topics, maintained that from its title and content it was clearly promotional in nature. This is a magazine published in the United Kingdom. Reprints of it would be available to interested parties within the United Kingdom. It is therefore clearly available to a UK readership. He suggested that it was vital that the Committee should be capable of regulating the content of articles of this nature, and that it was unacceptable for the Respondent to be able to avoid responsibility under the Code of Practice, simply because its parent company was said to be the party that actually placed the promotion or were responsible for the content in the article.
The Respondent’s representatives accepted there was no disagreement that the promotion of a one shot programme was contrary to the product’s Europe-wide SPC. It was further confirmed that this meant the promotions were clearly “off label”. Finally it was also confirmed that the Complainant’s own product, which was licensed for a single shot programme, had huge attraction to the pig farmer.
The Respondent’s representatives emphasised that they had in no way approved of the promotions and that the reason that they had been given an opportunity and took up the opportunity of inviting delegates from the United Kingdom to the symposium was simply one of building relationships and the Respondent had not been involved in the launching of the product and its one shot capability programme. Indeed, they were unaware of the existence of the brochure or of its content until they were at the symposium; or even the timetable for the symposium. It was stated, by the Respondent’s representatives, that UK managers of ISP, in attendance at the symposium, realised that changes would need to be made to the original brochure before it could be released in the UK.
The Chairman asked if they did not point out to those running the symposium and/or to their parent company of the error, that the promotions were not in accordance with Europe wide SPC? The response was that they had not, because the Respondent’s representatives maintained that they were not that much in communication with those responsible for the running of the symposium, and the production of its brochure, but accepted that the Respondent was represented at the symposium.
Again in answer to the Chairman, the Respondent’s representatives stated that their parent company was based in the Netherlands, but did not form part of the Dutch self-regulatory body (FIDIN), equivalent to NOAH. There was a separate Dutch subsidiary, who were members of that body. The parent company was therefore not a direct member of any of the national self-regulatory bodies.
The Respondent’s representatives stated that they had no contact with International Pig Topics, nor with their “global” colleagues in the parent company, and that they used the publication “Pig World”. The fact that International Pig Topics was printed in England in their view was completely irrelevant. What mattered was the amount of United Kingdom readership, and the amount of control (which the Respondent had none) and/or, who was the cause of the content of the article (which the Respondent was not).
The number of United Kingdom delegates at the symposium were six, who constituted six veterinary surgeons. It was acknowledged that although the number of invitees was low in numbers they would, nevertheless, certainly have amounted to about 50% of those specialists supporting UK pig farming as it was highly intensive and specialised.
In answer to queries from members, the Respondent’s representatives said that they were not in a position to recall whether the United Kingdom veterinary surgeon attendees had been advised either at the symposium or afterwards that the promotion was of an off-label use, so it must be assumed that no attempt was made by the Respondents present at the symposium to advise UK delegates of that unlicensed claim. However, being veterinary surgeons it was suggested that they would be bound to appreciate that fact. They also stated that in no way was the technical brochure one that was used or produced by the Respondent, and that they had no involvement with it or its content. They agreed that the Complainant’s competitor product was the present market leader. They agreed that a one shot programme could have potentially very significant effect within Europe and globally in the market.
The Complainant’s representative made two points arising out of the Respondent’s representatives’ presentation. Firstly, he suggested that, where a periodical containing a promotion may be printed is not material. What matters is the readership and responsibility for publication. Secondly, he expressed his great concern again as to how promotions of the use of a product that was off-label throughout Europe, could be properly regulated if the individual subsidiary companies that were members of the national self-regulatory bodies were held not to be responsible for the actions of their parent company in carrying out those promotions, simply because the parent company was not a member of any of those individual national self-regulatory bodies. He pointed out that although during the period April through to July the vaccine was not available in the UK market, his concern was that the information given at the symposium and/or having been read in the article within International Pig Topics could have misled veterinary surgeons to think that a one shot programme could be used in accordance with the product’s SPC when the vaccine did become available.
The Committee came to the following decisions:
1. In relation to the promotional items 1 to 4 contained in the Technical Brochure distributed at the symposium Portugal, viz:-
“..… and officially registered label claims were granted for ….1 x 2 ml dose scheme”
Graph entitled “Porcilis PCV once”
“A single dose of Porcilis PCV” and
“..… measured after a single vaccination”
the Committee’s unanimous decision was that these promotions were in breach of both Clauses 4.6 (“all information must be presented so as to promote the correct use of medicines”) and 4.7 (“Promotion must not be inconsistent with the SPC …”) for the following reasons:
- That the UK member company comprising the Respondent: Intervet UK Limited (trading as Intervet/Schering-Plough Animal Health) voluntarily invited United Kingdom veterinary delegates, representing a significant percentage of the veterinary consultancy related to United Kingdom pig farming, to the European launch of its Porcilis PCV vaccine at which the Technical Brochure was distributed to delegates, including the UK delegates.
- The Technical Bulletin referred to Porcilis PCV being administered by a single dose which is inconsistent with that product’s Europe-wide SPC.
- The Respondent by its representatives accepted that the inclusion of this claim was inconsistent with the product’s marketing authorisation.
- The provision of this promotion of a use inconsistent with the SPC was, in effect, acknowledged by the Respondent by its invitation given to the UK delegates prior to its own UK launch of the product which occurred some 3 months later, without that inconsistent claim.
- The mere fact that the promotion occurred abroad was not considered by the Committee to be a significant factor in this day and age. What is significant was that the guests of the Respondent represented a significant percentage of UK veterinary consultants in the pig sector.
- The Committee also took into account that it was plainly clear from the large market share of the Porcine Circo Virus type 2 vaccine owned by the Complainant, Boehringer-Ingelheim, that being licensed for one shot (which that vaccine is) is an important selling point in the UK market and thus was a significant characteristic at the time of the promotion.
- Bearing in mind the above points there was placed, on the Respondent, a greater onus to draw attention to its UK invitees that the product was not actually licensed for single shot application.
2. In relation to item 5 contained in the journal ‘International Pig Topics’ : ‘Porcilis provides this with a one shot programme of 2 mls of vaccine at three weeks of age’, contained in the article “It’s as easy as One, Two, Three”, the Committee noticed on reading it that although, it purported to give factual information about Japanese trials of the product which showed that one shot was “just as effective” as two, there was considerable emphasis on Europe (e.g. the Austrian trials) and the article reported on the launch of the product in Europe. There was thus a considerable “advertorial” element to the article i.e. an article which was in essence intended (or part intended) to promote a particular product. The Committee felt that the overall flavour of the article by the wording used, was to promote in Europe the use of a one shot programme which is inconsistent with the product’s SPC and, therefore, if the Respondent had been responsible for the publishing of the article, it would have been in breach of Code of Practice Clauses 4.6 and 4.7.
However, the Committee was satisfied that the responsibility for the promotion was entirely that of Intervet International BV, the Respondent’s holding company, and that the Respondent took no part either in the content of the article or in its publication. Accordingly, the Respondent had no control over the existence of the journal article and bearing in mind further that the journal in question is said to have only 4% of its readership in U.K. (even though that might represent a significant part of the pig market), the Committee unanimously considered there was no breach, as the promotion was not carried out by a member of NOAH.
However, the Committee desired that there be formal recognition of its concern that the body responsible for this promotion, which is not consistent with the product’s SPC throughout Europe, is not a member of any national animal medicine association and that in the interest of proper self regulation, IFAH-Europe (of which body Intervet International BV is a member), should take responsibility for this and be given powers accordingly. As a result, the Chairman of the Code of Practice Committee was asked to write to IFAH-Europe to express the Committee’s concerns.
All participants found in breach of the Code are required under Rule 15(i)(a) to give an undertaking that the practice in question (if not already discontinued) will be discontinued.
Intervet/Schering-Plough Animal Health have been required to sign the following Undertaking:-
1. We acknowledge the decision(s) of the Committee in Case 275/07/09 as set out in your letter of 12 August 2009.
2. To be completed in all cases
We accept the decision(s) of the Committee and undertake that the practice(s) in question (if not already discontinued) will be discontinued forthwith, and to that end, we have taken the following steps in relation to any promotion of Porcilis PCV®:
(a) Forthwith to cease and immediately to suspend any practice which includes any claim that the product can be applied in a one shot programme until or unless specifically authorised for such treatment by the product’s SPC.
3. We hereby give an assurance that we will take all possible steps to avoid a similar breach, or breaches, of the Code occurring in the future.
The complaint involved two items. Firstly, the phrase “Vets and nurses are uniquely placed to provide informed advice” on the inside cover of the detailer, allegedly in breach of Clause 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’.
Secondly, the phrase “Tried and trusted” on page 4 on the detailer, allegedly in breach of Clause 4.5, in that:
‘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.’
The Complainant maintained that it was not tried and trusted. Fipronil (as the active ingredient) is tried and trusted, but not the new formulation, so it cannot be said that EFFIPRO is tried and trusted.
The Chairman asked for clarification with regard to the classifications and was briefed accordingly with the emphasis on who was allowed to prescribe and dispense the respective categories.
The Chief Executive advised that pivotal to the complaint is the comment in the SPC, in that it is only to be supplied on a veterinary prescription, which is not entirely true. In a letter before the Committee from the VMD Director of Licensing, it was stated that provisions in the SPC to this effect were a mistake.
The Chairman reverted to the first item; “Vets and nurses are uniquely placed to provide informed advice”. There are a lot of comparative advertisements, but vets and nurses are probably more knowledgeable than SQP’s ‘Uniquely’ is a bit superfluous; an abused word and suggested a better description would be ‘best placed’. It is a long way down the line where it says this is a POM-V; although it does say NFA-VPS on the leaflet. That statement is in a section on the flea market. What is the real complaint?
A discussion then ensued, in order to brief the Chairman, and to explain the changes in the market brought about by regulatory review prior to the new regulations being released in October 2005. Merial had had a lead product for the last 12 years: FRONTLINE. Merial volunteered to change FRONTLINE to NFA-VPS, the background to the Competition Commission was then covered in relation to this product sector.
Effipro Spray is POM-V, in line with equivalent Frontline formulations. Whereas the ‘Spot on’ formulation is NFA-VPS. In response to a query from the Chairman as to why the spray had been classified POM-V – a veterinary member of the Committee explained that because it was also licensed to treat an additional condition for which the ‘Spot On’ formulation was not licensed, for example, mite infestation, which would require a veterinary diagnosis.
The Chairman reported that there were 2 complaints; the first is that information about animal medicines must be accurate. The second page of the promotional item contained largely general information about parasites. A Committee Member referred to the first bullet point – losing share through other markets. The vet can still sell a NFA-VPS product, but an increasing number of customers are now ‘shopping around’. Clients will often get it from the surgery and buy from vets initially, and then buy subsequent needs dispensed from a retail pharmacist on the internet. If a practice has a nurse, who has qualified as a SQP, then they would be able to deal with the sale and supply without direct veterinary involvement. But such sales have to come from a registered retail premises. So the representation was considered not actually to be an inaccurate statement, as it made up a 1/3rd of the pie chart, illustrated in the detail aid. This remark needed very careful consideration about being too restrictive. A lot of people go to vets and nurses, so was ‘unique’ referring only to vets and nurses? It depended on how you use the language.
The Chairman said that however tenuous the statement, Clause 4.5 of the Code could be more relevant to the issue. Are vets and nurses uniquely placed? Is that an incorrect statement? Depends on what people will see as ‘uniquely’ and nobody else. ‘Uniquely’; best placed? SQP’s are just as likely to give informed advice? So are vets “Best placed”, is it incorrect or not? The leaflet is clearly a veterinary detailer as it talks about clients and practitioners, Vets and nurses uniquely placed. What was meant by this statement?
In then considering the second item ‘Tried and Trusted’ the complaint suggests that the new Spot-On, from Virbac, includes the same active ingredient, so is just a generic. Tried and trusted was at the top of the page. Two separate sentences say what it was. Was it in this case trying to imply that everything on that page of the detailer is ‘tried and trusted’?
Two concerns were expressed by independent members of the Committee – when a new generic is put into the market, it is often only afterwards that it is established what the problems are, so it can be argued that it is ‘tried and trusted’ only as a brand, even if the active ingredient is the same. However, ‘Tried and tested’; from the regulatory authorities perspective, would refer to the active ingredient and not the brand. But this was directed at an educated audience. If there were any notable differences, e.g. if the excipient was different and not proved to be safe, then the VMD would have made it POM-V. This is a new formula with an old very well established active ingredient, which has undergone efficacy, toxicity studies and clinical trials. So one could say any drug can be described as ‘tried and trusted’. This product is the same active ingredient, but not exactly the same formulation, as Frontline, so it has not been tried and tested as a brand in the field. So, on the one hand it is tried and trusted as active, on the other new as a brand
The Company Representatives were then invited to join the meeting. The Complainant’s representatives were Ms Rachel Ballantyne and Mr Jonathan Hill and the Respondent’s representatives were Ms Chris Liggett and Mr Chris Taylor.
The Chairman opened the discussions by stating that complaint has been made against the phrase “Vets and nurses are uniquely placed to provide informed advice” in the EFFIPRO leaflet breach Clause 4.3. The second complaint being the phrase “Tried and trusted” and considered by the complainant to be a breach of 4.5, as it in a sense, misleading.
The Chairman asked if substantiation of the material had been provided to the Complainant within 5 days and whether that matter had been resolved. The Complainant advised no.
The Complainant’s Representatives presented the Complainant’s case, by first explaining that there had been a number of changes within the ‘ecto’ market, some products had been reclassified so many vets have sought out prescription only (i.e. POM-V) products.
Following on to the second point – ‘tried and trusted’ the Complainant’s Representatives stated that the Merial brand has been around for a long time and involved a lot of time and resources which they could describe as being tried and trusted. The Complainant took very seriously the situation when another company rides on the back of this accolade, without having earned the right to so.
The Complainant’s Representatives said they did believe the Respondent was trying to mislead, by the product being available through veterinary prescription. They felt the words ‘uniquely placed’ epitomises their strategy and upon questioning, felt ‘well placed’ was a better substitution. The Complainant’s Representatives did not agree vets are ‘better’ placed than SQPs and felt ‘unique’ is too strong and misleading. Vets are going to find this product desirable because of the perception that it is going to be available only as a POM-V.
Merial also stated that it was they who brought the packaging anomaly to the VMD’s attention, not Virbac.
The Complainant’s Representatives then dealt with the phrase ‘tried and trusted’ and reiterated they had spent a lot of time, resource and effort in being able to use the phrase ‘tried and tested’ going through regulatory procedures to use it on their advertising material. The active ingredient and formula applied to the whole page. Effipro is a new product of Fipronil in a new formulation. So Virbac are really introducing a new product. The new formulation cannot be tried and trusted – and the Respondent had not been able to substantiate this claim, as no data existed to back it up – so they considered it to be in breach of 4.3 and 4.5. The Chairman commented that the word ‘new’ is liberally splashed all over the pamphlet. In relation to the word ‘trusted’ the Chairman asked what would they say the word ‘trusted’ would mean to the vet? The Complainant’s representative said this was an emotive term; ‘trust’ is something they have in a brand and not just the active ingredient. The Chairman asked if ‘new’ limited that perception? The Complainant’s Representatives said it was a contradiction in terms. They did not see how the two can appear together – i.e. long established equals ‘tried and trusted’, not new. The Complainant’s Representatives said that vets buy active ingredients from trusted brands. You cannot presume it has the same efficacy.
The Respondent’s Representatives responded by strongly refuting that the Respondent’s promotion misled the vet to believe the product was classed as a POM-V– as there were several pieces of evidence to back it up. Indeed if a Google search was made for EFFIPRO the results indicated that non-vet outlets were selling the product e.g. ‘on-line’ pharmacists.
It stated clearly on the packaging it was a NFA-VPS product, so why would their Company hoodwink the profession into believing it was a POM-V product, as this would have been detrimental to their Company’s credibility.
The advice the Respondent had received from the VMD requesting the product to be classed as POM-V had been incorrect, it had been the VMD’s mistake and in fact VMD had stipulated that 12 other products had been involved in this error.
The Chairman asked, notwithstanding the VMDs mistake, whether the leaflets were prepared in the belief that it was a POM-V product. The Respondent’s Representatives stated that they had to abide by the advice/instructions given by the licensing authority, the VMD, at that time. To put the line “only on vet prescription” was a disadvantage to them and a challenge to design the leaflet for the veterinary profession, as the leaflet had not been sent out to SQPs or Pharmacists. But there is information available for the Pharmacist/SQP’s, but a separate leaflet had not been produced aimed at them. If an SQP/Pharmacist requested the information, then the Respondent could supply the leaflet in question but depending on the nature of the enquiry, a different version might be supplied.
The Respondent’s Representatives defined the terminology ‘uniquely placed’ in context of the leaflet. They maintained the vet was uniquely placed because they have the advantage of physically seeing the dog or cat to allow a diagnosis. A SQP does not see the animal and is unable to diagnose as this is against the law. Uniquely means ‘and no one else’ but the key word used in the phrase is ‘placed’ and they felt the vet is uniquely placed. Diagnosis is not required for NFA-VPS. The Chairman asked if what they were saying was that vets and nurses have an advantage because they see the animal and they can diagnose. But could a pet owner go into a veterinary practice without the cat or dog and purchase Effipro? The Respondent’s representatives said yes; the vet will invariably say we need to see your dog or cat, otherwise no different to a SQP or pharmacist. A Vet can do it, a non vet SPQ cannot. The Chairman asked in the context of the pamphlet, why use the word ‘veterinary’ and the Respondent replied to differ from a human medicine, as it is a veterinary generic.
The other major point, the Respondent’s Representatives continued, was the definition of ‘tried and trusted’. By a dictionary definition it is shown to be effective by testing. Nobody disputes Fipronil is tried and trusted as it has been on the market for 12 years. It is also licensed in 12 European states. The Respondent would argue that it is tried and trusted intrinsically as it has a Marketing Authorisation; it is therefore by default tried and trusted. The Chairman asked whether trust meant over a period of time which the Respondent’s Representatives agreed it was the case.
The Respondent’s Representatives, in response to the Chairman’s enquiry whether “Trust” did not imply an emotive element, that although trust has a degree of emotional element to it, equally once VMD has determined the product is safe and efficacious, and it is approved via the licensing system, this displays trust in the product.
Upon enquiry, the Respondent’s Representatives strongly disputed the juxtapositioning of the statements on the page in question created a misconception. Under the proven agent there are three bullet points leading to the new formulation. They had not hidden the fact that the formula is a new product with a tried and trusted active ingredient – the first time it has been used. Up to now the active ingredient has been sold by Merial, it came off patent in May this year. It was reclassified in 2006 from POM to NFA-VPS. The spray is still POM-V. The Respondent’s Representatives advised that the percentage of sales of the spot-on to the spray is 80 – 20. One of the main reasons for it still being a POM-V is that it is highly inflammable – and therefore there are concerns about drying off the pet after you spray, keeping children away, etc..
A Committee Member introduced himself as having 40+ years experience in the veterinary profession and commented that you sometimes only see problems after the product has gone into field use. The Member continued, when we use a new product, we use it very carefully and are uneasy with the word ‘trust’ when first introduced on the market. The Respondent’s Representative said that the new formula can be trusted, as it had been licensed to perform. Intrinsically tried and trusted by a regulatory authority, otherwise it would not be on the market. You have to accept a certain amount of trust because it has a MA number on it. You have to take it on trust and trust the regulatory process. A new active ingredient would of course be POM-V, but there are now fewer new actives, and an increasing number of generics. This is ‘Tried and trusted’, not just ‘tried and tested’, the context in which the promotion is being made is important.
In final response, the Complainant’s Representatives said trials on a small number of animals to establish a generic licence are different to many years on the market, thus their brand had accumulated trust. The Complainant had challenged ‘New Vet exclusive’ on the Respondent’s web site, and if they had not reported this to Virbac, they believed it would have still been live on the website. The Respondent explained that there was a pan European campaign on their parent website (French company). The Respondent had informed their European division that this product was not classed as POM-V in the UK, but unfortunately the website was launched by an agency, therefore, the Respondent had no direct control on this being made public, however, they had the website changed in 12-14 hours once they had been made aware of it by the Complainant.
The Respondent’s representatives were asked about the split of sales through the respective sectors of vet and trade. They did not have the actual figures but estimated 50% vets / 50% SQPs but anticipated this to shift more towards SQP’s.
Both parties were thanked for their contributions and released from the meeting.
Committee discussions ensued, resulting in majority decisions as follows:
1. The essence of the Committee’s considerations was that the phrase “Vets and nurses are uniquely placed to provide informed advice” is to a large extent true, because firstly, Vets are able to provide diagnoses and secondly, Vets and nurses may see the domestic animal and, therefore, would be in a unique position to ascertain the cause of the symptom.
The Committee considered that as this was a pamphlet aimed at veterinary practices, that Vets and nurses would, in any event, know whether or not they were better placed to provide information and advice than pharmacies and SQPs and were, therefore, highly unlikely to be influenced by such a statement. Furthermore, vet nurses would generally be more familiar with whether a product would be POM-V or NFA-VPS.
In relation to the complaint under 4.3, the Committee’s view was that this particular phrase was far removed from specific information about EFFIPRO and it was tenuous to suggest that the vet practice and nurse upon reading this statement would believe it was a POM-V product.
Accordingly, the Committee found no breach of Clause 4.3.
2. The essence of the Committee’s considerations was that the phrase “Tried and trusted” means that in relation to the word “tried”, that is has been tested and found efficacious in dealing with the illness/problem, but in relation to the word “trusted”, that would mean to the average person, in particular vet practices, that it will have been on the market for a sufficient period of time such as to gain the confidence and trust in those practices who supply it, and the Respondent’s argument that ‘trust’ simply meant it was licensed and had trust in the regulatory authorities, was an artificial interpretation of the word ‘trust’.
However, the Committee accepted the Respondent’s submission that the pamphlet, when read in context by the average reader, where the statement ‘tried and trusted’ appeared, would perceive this as referring to the active ingredient Fipronil as opposed to Effipro, in particular because of the prominence and emphasis given in the pamphlet to Effipro being a new formulation of Fipronil. This was not a unanimous view but the view of a significant majority.
Accordingly, the Committee found no breach of Clause. 4.5.
The promotional material involved related to Pfizer’s product Rimadyl™ Cattle, which appeared in an advertisement in the Farmers Weekly, and which was distributed at the South West Dairy Show, and in a Farm Business article. The complaint related to three items:-
“The only single shot cattle anti-inflammatory with zero milk withdrawal” (Advertisement, published page 13 of the Farmers Weekly Official Dairy Event Guide, September 2009)
“A genuine one shot treatment.” (A5 and A4 Pfizer promotional brochures, distributed at South West Dairy Show, 8 October 2009, and submitted had been collected from a veterinary practice: 8 October 2009, respectively)
“Extended duration of action.” (Farmer business article: 4 September 2009, A4 Pfizer promotional brochure).
The Complainant, Merial Animal Health, maintained that the following Clauses of the Code of Practice were broken by these three items of promotion:
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
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.
6.1 The products or services of other companies must not be disparaged either directly or by implication.
The Complainant maintained that it was not correct that this product is the only single shot, zero milk withdrawal NSAID, as usage of their product Ketofen ® could make the same claim.
Pfizer’s response was that their understanding from discussions with practitioners and farmers, Ketofen® needs to be given for a full three-day course to achieve full therapeutic effect. Nevertheless, Pfizer had given a voluntary undertaking to ensure that in future advertising and materials they would not use the word “only” in relation to single shot NSAID with zero milk withdrawal period.
The Chairman emphasised that notwithstanding the voluntary undertaking, the Committee still had to take a view on whether item 1 constituted a breach as maintained by the Complainant.
In relation to item two, the concern was that the use of the word “genuine” implied that other products did not have the one shot quality. Pfizer’s response was simply that it was a true and factual statement, emphasising to the reader (who might otherwise be sceptical), that the quality claimed for the Respondent’s product was entirely genuine, and no comparison with another product was intended.
Members pointed out that there were two other products licensed for one shot treatment, but they all indicated “up to three days”. The implication of a half life therapeutic effect in the Respondent’s formal response was thought to be material, and it was necessary to compare the SPCs for the products and other products. The use by the Respondent of the article Pang et al, which was dealing with an off SPC claim, was felt to be disingenuous. Three days was commonly used for a single shot. The use of a single shot, often depended on the infection in question. In some circumstances two shots could possibly be toxic. It was felt that it was necessary to see all the promotional words within the context of and positioning in the brochure, which created an image, which perhaps could be taken as comparative, and therefore misleading.
Item 3 was then considered. The Chairman drew attention to the press release and the single treatment said to be in breach of Clauses 4.3 in 5.2, in that the claims cannot be substantiated. The Chairman suggested that the question for the Committee was: “what does ‘extended duration’ mean?” Additionally, was the Committee persuaded by Pfizer’s response that it was not responsible for the press article?
A discussion ensued, considering the academic articles referred to. In particular, it was pointed out that the fact that there may have been a therapeutic effect within the first 24 hours does not mean that there is an extended duration of that therapeutic active benefit. The product may be clinically active, but not having any therapeutic effect after the first 24 hours. It was doubted whether the Elitok and Pang et al papers were sufficient substantiation.
At this point the parties’ representatives were invited into the meeting. They were: Ms Fiona MacGillivray and Mr Brian Rice from the Complainant Company: Merial Animal Health and Dr Edward Ferguson and Mr David Gilbert from the Respondent Company: Pfizer Animal Health.
The Chairman explained to the Representatives for both parties that the Committee were considering two cases that day, both involving the same product, the same Respondent, and to some extent the same promotion. Nevertheless, the cases were distinct and it was therefore intended that each would be dealt with separately.
The Chairman also notified the Representatives, that one of the members, Mr Nigel Underwood, might be said to have an interest in that his Company’s product was involved in the same market. Both parties’ Representatives indicated no objection.
The Chairman informed the parties’ Representatives that the Committee had read and discussed the papers submitted by the parties.
The parties respective Representatives proceeded to present their cases.
In relation to item 1 the Complainant considered that whilst the offer by the Complainant to remove the reference to the word: “only” was a concession, it did not constitute a sufficient corrective action. Item 2 constituted an exaggeration, by suggesting that, it being the only genuine single shot, other products did not have that capability. This was not capable of being substantiated, contrary to Code of Practice Clause 5.2., as well as also being misleading and inaccurate. Whilst the literal meaning as suggested by the Respondent, could possibly be considered to be accurate, common use of the language within the context of the brochure clearly disclosed an implication that other products did not genuinely have this competence and was therefore a misrepresentation. It also disparaged other products. The Representatives asked: why was it necessary for the Respondent to use the word “genuine”, if it was not for a comparative purpose?
As regards item 3 and the words “extended duration”; within the product’s SPC there was no claim for extended duration. Extended duration had to reflect actual therapeutic action, not merely being clinically active. The promotion was accordingly misleading and constituted an exaggerated claim.
The Respondent had produced two scientific papers. In the Claimant’s Representatives’ view, nothing in these substantiated the promotion, which viewpoint was questioned closely by the Committee. They made a final point, which was that of their view, the key relevance of the data within the SPC was referable to safety, rather than any form of extended duration.
The Respondent’s case, referable to item 1, was that they had given an undertaking not to use the word “only” in the context of the promotion being made concerning a one-shot treatment. It was their genuine understanding, following consultation with veterinary practices that, in general the Complainant’s product was used at least three times, and therefore although they were willing to give the undertaking, they still took the view that the promotion was not in breach of the Code of Practice. Several members of the Committee raised questions, as regards this suggestion. It was asked why they had agreed to remove the word “only” if it was not, in effect, accepting the argument of the Claimant. The Representatives’ response was that their belief was that Ketofen could be used by a single shot, but that in their experience it was routinely provided by three shots. The Chairman queried how it was that the assurance had preceded the Dairy Event Guide of September 2009 where there is a reference to “Only single shot”. The Representatives explained that they had given their assurance in good faith and referred to future publications. This particular guide had already gone to press at the time the assurance was given.
A member queried the publication of the promotion using the word “only” was still being distributed within the South West area. The Representatives stated that they had contact with the field force to ensure that any reference to the word “only” was to be withdrawn and not used and that they had not done anything deliberately to break their voluntary undertaking.
On item 2, it was stated the term “genuine” was simply a statement of fact and there was no intention to make any comparison with any other product. They were emphasising the particular quality of their own product having a single shot quality for which it was licensed.
On item 3, it was maintained that what was stated was correct in that the product was active for 72 hours. A general understanding within the industry and within veterinary practices was that anything which was active beyond 24 hours was an extended duration. They suggested that the term and the evidence supported an efficacy for that period. Anecdotal evidence supported their claim that the results of a single injection could be perceived after two or three days.
The Representatives were closely questioned by the Chairman and other members of the Committee regarding this claim and clarification was sought (in the context of concurrent use of an antibiotic) as to the distinction between therapeutic benefit as opposed to the antibiotic being clinically active; and that any benefit related back to its therapeutic activity within the first 24 hours. Reference was also made to the Elitok paper and its particular meaning which the Respondent’s Representatives endeavoured to show had support for their contentions. On being questioned as to statistical analysis, they accepted that “p equalling less than 0.01” was of minimal statistical significance, but they nevertheless suggested it showed a difference. On being asked why there was such a paucity of evidence to support their claim, it was explained that trials on this subject were very difficult to put in place.
Both parties’ Representatives were thanked for their presentations and left the meeting.
The Committee discussed all three items of complaint in some depth, particularly as regards item two.
The decisions of the committee were as follows: —
In so far as item 1 “The only single shot cattle anti-inflammatory with zero milk withdrawal” is concerned, the unanimous decision of the Committee, bearing in mind that the target audience was Farmers and Farm Managers, was that the product Rimadyl Cattle® was not in September 2009 the only single shot cattle anti inflammatory with zero milk withdrawal, and the statement therefore misleads and is inaccurate, contrary to Code of Practice clause number 4.3, and is an exaggerated claim incapable of substantiation, contrary to Code of Practice clause number 5.2.
The Committee in their consideration noted that the Respondent had offered to remove the reference to “only” in inter company correspondence.
In so far as item 2 “A genuine one shot treatment” is concerned, by a majority, the Committee decided there was no breach. It was the Committee’s view that genuine was not intended to suggest that other single-shot NSAIDs were not genuine but rather that Rimadyl was truly a single-shot vaccine (in case the reader doubted such). However, the Committee were concerned by the graph on the same page of which these words were a header, which graph purported to show the serum half lives of NSAIDs licensed in cattle, combined with promotional words “Rimadyl Cattle’s unique pharmacokinetics are integral to its extended action”, which statement the Committee considered is unsupported by any scientific evidence relied upon by the Respondent, and is therefore unsubstantiated. Had the Complainant complained about the inclusion of these words, the graph utilising serum half lives, data not justified on the evidence given to the Committee as established as having any connection with pharmacodynamics, and therefore enduring action, all under the heading claiming a genuine one shot treatment, the Committee would have found a breach by the juxtapositioning of these three items, contrary to Code of Practice clause 6.1, as well as clauses 4.3 and 5.2, in that the Committee felt the promotion in this page, taken as a whole, was not only misleading, and inaccurate, but also disparaged competitor products. The Complainant did not raise its complaint in this form, and by its standard convention, the Committee therefore could not find a breach, as the words “A genuine one shot treatment” in themselves are acceptable.
In so far as item 3 “Extended duration of action” are concerned, the unanimous decision of the Committee, bearing in mind that the target audience were farmers and farm managers, was that such a phrase meant that Rimadyl was pharmacodynamically active for a period greater than 24 hours hour after injection i.e. it was therapeutically active in alleviating inflammation after 24 hours. The Respondent had failed to substantiate that its product Rimadyl Cattle® had this capability from the scientific evidence on which it relied. Pang and Elitok did not support the proposition that Rimadyl was pharmacodynamically active after 24 hours. Accordingly this promotion was also contrary to Code of Practice clauses 4.3 & 5.2, in that it was misleading, inaccurate and contained an unsubstantiated claim.
The Committee also considered the offer made by the Respondent by way of voluntary undertaking, but noted that it had not been accepted by the Complainant and in these circumstances did not consider further action or consideration was necessary.
All participants found in breach of the Code are required under Rule 15(i)(a) to give an undertaking that the practice in question (if not already discontinued) will be discontinued.
Pfizer Animal Health have been required to sign the following Undertaking:-
1. We acknowledge the decision(s) of the Committee in Case 277/10/2009 as set out in your letter of 11 November 2009.
2. To be completed in all cases
We accept the decision(s) of the Committee and undertake that the practice(s) in question (if not already discontinued) will be discontinued forthwith, and to that end, we have taken the following steps in relation to any promotion of Rimadyl Cattle®:
(a) Forthwith to cease and immediately to suspend any practice which includes any claim that Rimadyl Cattle® is “The only single shot cattle anti-inflammatory with zero milk withdrawal”, or which by other words, connotations or means, suggests or implies or tends to imply that that product is the only single one shot cattle anti-inflammatory with zero milk withdrawal; or
(b) Forthwith to cease and immediately to suspend any practice which includes any reference to Rimadyl Cattle® having “Extended duration of action” or which by other words, connotations or means, suggests or implies or tends to imply that that product has extended duration of action. In that regard we agree to notify the XL Vets association, and any other veterinary associations or organisations to which such promotion has been distributed, that the above promotional words should be removed from any written material they may be utilising in their member practices or practices’ offices
3. We hereby give an assurance that we will take all possible steps to avoid a similar breach, or breaches, of the Code occurring in the future.
This three item case was brought by Boehringer Ingelheim Limited. The promotional material involved was Pfizer’s product Rimadyl Cattle® which appeared on the Pfizer stand at the Dairy Event held on 16th and 17th September 2009, in the September issue of Dairy Farmer and on the Farmers Weekly Interactive website. The three items were:-
- Pfizer Stand at Dairy Event held at Stoneleigh Park, Warwickshire, on the 16th and 17th September 2009 ‘Rimadyl cattle has the longest half life of cattle NSAIDs’ juxtaposed with “Long Duration – 3 days serum half life”
- September issue of Dairy Farmer page 52, Rimadyl Cattle® is “Claimed to act fast and said to provide longer action than its competitors”
- Farmers Weekly Interactive website – quote from Dave Gilbert: “The fast-acting drug can also provide several days’ activity, says company vet Dave Gilbert”
The Complainant alleged that item 1 breached Code of Practice Clauses 4.2, 4.3, 4.5, 4.7, 5.1, 5.2 and 5.5, in that it attempted to link a pharmacokinetic property (which may or may not be an actual benefit) into a pharmacodynamic and therefore implied a clinical benefit to the reader. Further, that item 2 breached Code of Practice Clauses 4.2, 4.3, 4.5, 4.7, 5.1, 5.2 and 5.5 in that the Complainant alleged this statement claimed a comparative benefit over other cattle NSAIDs. The Complainant also believed that scant and contradictory scientific evidence exists with regard to the duration of action of carprofen, and comparison of effect to other NSAIDs. Additionally, the Complainant alleged that item 3 breached Code of Practice Clauses 4.2, 4.3, 4.5, 4.7, 5.1, 5.2 and 5.5, in that it attempted to link a pharmacokinetic property (which may or may not be an actual benefit) into a pharmacodynamic and therefore implied a clinical benefit to the reader.
The Clauses of the Code referred to are set out in full 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. Such substantiation need not be provided, however, in relation to the validity of indications approved in the current marketing authorisation. 4.7 Promotion must not be inconsistent with the SPC, except that a veterinary surgeon or other appropriately 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 . 5.1 Claims for the usefulness of an animal medicine must be based on an up-to-date evaluation of all the evidence and must reflect this evidence accurately and clearly.
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. The Complainant also provided details of an inter-company voluntary undertaking in connection with a similar promotion in June 2009
The Chairman decided, with the Committee’s full approval, that given their lengthy consideration of matters in the previous case, and the fact that they had all had read the papers, there was no need to have a preliminary discussion and that the parties’ Representatives should be invited to the meeting forthwith to give their presentations.
The Complainant’s Representatives were Ms Laura Randall and Mr Steve Williams / Boehringer Ingelheim and the Respondent’s Representatives were Dr Edward Ferguson and Mr David Gilbert from Pfizer Animal Health. Dr Laura Saunders, being employed by Merial Animal Health, the Complainant in Case 277, joined the meeting at this time. The party’s representatives were asked if they had any objection to her being part of the Committee, given her involvement with one of the parties in the previous case, and the representatives of both parties stated they had no objection.
The Chairman explained to the Representatives for both parties that the Committee were considering two cases that day, both involving the same product, the same Respondent, and to some extent the same promotion. Nevertheless, the cases were distinct and it was therefore intended that each would be dealt with separately. The Complainant’s Representatives presented their case, stating that the Complainant’s two concerns were
- Misleading claims of duration of activity (pharmacodynamic effect) suggested or implied by long half life (pharmacokinetic property), contrary to Clauses 4.2, 4.3, 4.5, 4.7, 5.1, 5.2; and
- Unsubstantiated comparisons of clinical activity to other NSAIDs for use in cattle, contrary to Clause 5.5.
They also drew attention to Respondent’s voluntary undertaking given following their complaint made to the Respondent relating to a similar promotion contained in the Veterinary Times dated 1 June 2009 “We will not use the two statements ‘now you can do more…’ and ‘the longest half life..’ juxtaposed”, [and] “we will continue to use the half life information but will ensure that any promotional items do not imply or suggest any unlicensed therapeutic benefit.”
The Complainant’s Representatives maintained that the reason they were bringing this to the attention of the Code of Practice Committee of NOAH was that the promotion was misleading to the business user—that is to say, the farmer or the farm manager. Further, it was a transgression of the NOAH Code of Practice and also of the Respondent’s voluntary undertaking, and that this had occurred during a significant and sustained marketing of the product in its launch phase.
Relating to item 1, the Complainant’s Representative’s explained the difference between pharmacokinetic property (e.g., half life), which reflects how the animal reacts to the drug, and pharmacodynamic property (e.g. duration), which is how the drug acts on the animal. They emphasised that pharmacological understanding of the business user target audience was likely not to be comprehensive or complete. All indications are that despite the longer half life of Carprofen, it had no clinical benefit over other NSAIDs. They maintained that the business user is interested in therapeutic effect and clinical use, and therefore promotion of half life information is misleading, and does not reflect evidence, fairly or accurately and has potential to mislead through implying comparative benefit over other cattle NSAIDs.
In item 2, they maintained that the statement suggested a comparative benefit over and above other cattle NSAIDs. They further stated that the references provided by the Respondent did not provide substantiation of comparative benefit of therapeutic action over other cattle NSAIDs. They stated that Pang et al was an off SPC indication, whilst no comparison was made to other NSAIDs used in cattle in Elitok et al. They referred to Lockwood et al, suggesting this was a comparative clinical study, including three different NSAIDs, which indicated that despite the longer life of carprofen, it had no clinical benefit over the other NSAIDs and that flunixin and ketoprofen reduced calves pyrexia more quickly and to a greater extent than carprofen. Further, over 72 hours there were no statistically significant differences between the treatments with regard to clinical illness score.
The Respondent’s Representatives then made their presentation stating that they had been in discussion with the Complainant Company in June and thought that they had been able to reach an agreement. They emphasised their willingness to do so, and furthermore, their willingness to be flexible. They believed the statements made in the promotional material were factual and were not breaching any undertaking relating to what was within the SPC governing a one shot treatment. They maintained that they had never made a claim for pharmacodynamic benefit equating to longest half life. The promotion would stimulate farmers to ask appropriate questions and the proper intention of the promotion was to educate. It was suggested that the three-day half life calculation factor was not the sole reason for the promotion and that there was a full detail aid, as contained in the previous pages and in the total package supplied. These arguments were closely questioned by the Committee.
A dairy farmer member raised questions as to the validity of suggesting that there was an educational benefit. He suggested that the pictures implied a long duration, which by definition had to mean therapeutic or pharmacodynamic benefit. He suggested that any farmer reading the material would inevitably come to that conclusion. The Respondent’s Representatives suggested that that was not their previous experience.
The Chairman asked how interested they thought a farmer would be in anything which did not have a clinical benefit. The response was that a lot of people would not have the full explanation for the end result and would want to have such a full explanation to be able to properly understand and make proper choices.
A number of other questions on the distinction between pharmacokinetic and pharmacodynamic properties were put to the Respondent’s Representatives by the Chairman and other Committee members.
On item 2 the Respondent’s Representatives stated that the actual article in question had not been produced with their authority or under their control.
On item 3 the Respondent had never denied anything that they genuinely stated, but that (as in item 2) what was represented in the press came from a press meeting and interaction with a journalist. They stood by the content of the press release which had been provided in the package of papers supplied. What then resulted was by journalistic licence which had never been intended. What had been stated at the press briefing by Dr Gilbert was “It is fast acting and provides extended duration of action from a single treatment” The Representatives argued that the papers Elitok et al and Pang et al supported their contentions that the drug could provide several days action. The Representatives were questioned closely by the Chairman and other members regarding precisely when the press meeting had taken place, and exactly what had occurred, and the manner in which the referred papers were said to support the Respondent’s contentions, bearing in mind that the previously discussed distinction between pharmacokinetic and pharmacodynamic activities, and that the drug’s pharmacodynamic activity arguably was limited to the first 24 hours, and the fact that it was pharmacokinetically active later did not necessarily indicate a pharmacodynamic activity, and this did not appear to be supported for any longer period by the articles in question.
The Representatives of both parties were thanked for their presentations and left the room. There was a lengthy discussion to consider all three items of promotion, and also, what should be done as regards the voluntary inter-company undertaking.
The decisions of the committee were as follows: – In so far as Item 1 “Rimadyl Cattle has the longest half life of cattle NSAID’s” juxtapositioned with the words “Long duration – 3 days serum half life” was concerned, the Committee’s unanimous decision was that these words when read in the context of the page (including the graph) would mislead the reader (who would be a farmer or other technically unqualified person) to conclude that Rimadyl had pharmacodynamic qualities which lasted longer than other competitors. This was not substantiated by the evidence relied upon, and was therefore in breach of Code of Practice clauses 4.3 (misleading); 5.1 (reflect up to date evidence accurately and clearly); 5.5 (comparisons must be fair); and 5.7 (scientific opinion must be reflected accurately).
In so far as Item 2 “Claimed to act fast and said to provide longer action than competitors” was concerned, the Committee were satisfied unanimously that the Respondent was not responsible for these words which had been made by a third party journalist, who had attended a press briefing at which the information given was not reflected by the resultant article. Accordingly there was no breach. However, the Committee would emphasise that members should be careful as regards press briefings to ensure so far as they reasonably can that journalists reflect what is stated about products accurately; in particular taking into account what other material may be available about the product from other sources, which may lead to inaccurate and misleading statements being made.
In so far as item 3 “the fast acting drug can also provide several days’ activity, says company vet Dave Gilbert” was concerned the unanimous decision of the Committee was that the evidence relied upon by the Respondent did not justify the promotional words. The word “action” implied a pharmacodynamic effect, and that the pharmacokinetic quality which clearly was established by the serum half lives trial results relied upon, did not mean a corresponding pharmacodynamic effect. The mere fact that Rimadyl remained present in the blood of cattle for longer than other NSAIDs did not imply that it was therapeutically active for a longer period. Evidence would be required to substantiate such a claim. The Committee did not accept that Elitok or Pang (which related to off-SPC use) did substantiate such a claim. Pang related to off-SPC use and Elitok merely showed that Rimadyl when used with an antibiotic was more effective than when the antibiotic was used alone in reducing the clinical symptoms of bovine respiratory disorder in cattle over a 72 hour period (and not that it was therapeutically active after 24 hours). Furthermore, Lockwood suggested that in fact, there was little or no benefit from using carprofen (the active ingredient in Rimadyl) over a period of 72 hours compared to other NSAIDs. Whilst accepting that the sample in Lockwood was statistically insignificant, there was no study whose results contradicted Lockwood. Accordingly the promotion was in breach of Code of Practice clauses 4.2 (must reflect current knowledge and responsible opinion); 4.3 (misleading & inaccurate); 4.5 (capable of substantiation); 5.1 (must reflect evidence accurately) and 5.2 (avoidance of exaggerated claims).
The Committee were also concerned that the parties had previously come to an agreement, reflected by a letter of the Respondent dated 24 June 2009, regarding an earlier promotion, in which the Respondent promised not to use the two statements “Now you can do more…” and the longest half life …” juxtaposed in future promotional material and would …”ensure that any promotional items do not imply or suggest any unlicensed therapeutic benefit”. In the Committee’s view, such was an undertaking not to use the fact that Rimadyl had the longest half life to expressly or impliedly suggest that Rimadyl was therapeutically active for periods longer than other NSAIDs. The unanimous view of the Committee was that, upon proper consideration, the subject matter of the complaint, breached this undertaking The promotion clearly implied a therapeutic benefit from the fact that Rimadyl had the longest serum half-life.
Accordingly, after careful consideration of this matter, the Committee’s decision was to invoke in relation to those items Rule 15 (iii) and require that the Respondent suspends forthwith any of its promotions which expressly or impliedly suggest that the fact that Rimadyl has the longest serum half-life of all NSAIDs means that it is therapeutically active for a period longer than other NSAIDs whether by the wording the same or similar to Item 1 or 3 or otherwise.
On the 25 November 2009 Pfizer signed and accepted the decision of the Code of Practice Committee and undertook, in relation to any promotion of Rimadyl®:
(a) Forthwith to cease and immediately to suspend any practice which includes any claim that Rimadyl Cattle® is “Rimadyl Cattle has the longest half life of cattle NSAID’s” juxtapositioned with the words “Long duration – 3 days serum half life”, or which by other words, connotations or means, suggests or implies or tends to imply that that product has a long duration of activity; or
(b) Forthwith to cease and immediately to suspend any practice which includes any reference to Rimadyl Cattle® can … provide several days’ activity or which by other words, connotations or means, suggests or implies or tends to imply that that product has several days’ duration of action.
Following the Undertaking, an article was issued in the April 2010 edition of Cow Management entitled “No pain – and plenty to gain” with the statements:-
“A complete treatment in one single shot……” and further (after stating whether it’s for a calf with pneumonia or a severe case of mastitis);
“The job’s done – producers don’t have to worry about remembering to administer a second dose 12 or 24 hours later”.
On the 25th of June 2010 the NOAH Code of Practice Committee considered and found this to be in breach of the Undertaking and reported this to the NOAH Board.
On 28 September 2010 the NOAH Board discussed the Code of Practice Report and Pfizer were formally reprimanded for their conduct. Pfizer will be issuing a retraction correcting the statements. Additionally, the Board decided that if, within a period of one year, Pfizer Animal Health breach this or any other Undertaking, they will be suspended from NOAH membership.