Code of
Practice for the Promotion of Animal Medicines
Précis of Committee meetings held in 2009
Case No. 271. Merial Animal Health
- Boehringer Ingelheim Ltd: Metacam promotion
Report
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”.
Chairman’s note
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®.
Undertaking
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:
1. 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.
2. 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.
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.
30 March 2009 (for Case 271)
Back to list of cases...
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.
Report
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.
Case 272/04/09
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.
Case 273/05/09
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.
Back to list of cases...
Case No. 275/07/09: Boehringer
Ingelheim Limited/Intervet/Schering-Plough Animal Health
Promotional activities: Porcilis PCV
Report
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:-
a) 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.
b) The Technical Bulletin referred to Porcilis PCV
being administered by a single dose which is inconsistent with that
product’s Europe-wide SPC.
c) The Respondent by its representatives accepted
that the inclusion of this claim was inconsistent with the product’s
marketing authorisation.
d) 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.
e) 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.
f) 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.
g) 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.
Undertaking
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.
Back to list of cases...
CASE NO. 276/08/09 : MERIAL ANIMAL HEALTH / VIRBAC LIMITED : PROMOTION
OF EFFIPRO®
Report
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.
Back to list of cases...
CASE NO: 277/10/09 : MERIAL ANIMAL HEALTH/ PFIZER ANIMAL HEALTH :
PROMOTION OF RIMADYL™ CATTLE
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.
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CASE NO: 278/10/09 : BOEHRINGER INGELHEIM / PFIZER ANIMAL HEALTH:
PROMOTION OF RIMADYL™ CATTLE
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:-
1. 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”
2. September issue of Dairy Farmer page 52, Rimadyl Cattle® is “Claimed
to act fast and said to provide longer action than its competitors”
3. 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
1. 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
2. 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.
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