Code of
Practice for the Promotion of Animal Medicines
Précis of Committee meetings held in 2004-5 for Circulation
to the Veterinary Press
Case No. 236 - Merial Animal Health Limited v.
Intervet UK Limited regarding Nobivac Tricat and Nobivac FeLV Vaccines
This one item case considered the important issue of
whether a response to a technical enquiry was ‘promotion’ within the meaning
of the Code of Practice, because if it is not, then the Code of Practice
Committee, under its present jurisdiction, has no authority to consider the
complaint further.
The Complainant maintained that the provision of an
identical standard letter response to two enquiries from Veterinary
Surgeons, the first dated 17th June 2002 and the second dated 13 August
2003, constituted a breach of Code of Practice Clause 3 (bringing discredit
or reducing confidence in the Industry), Clause 4.3 (…must be accurate,
balanced and must not mislead …), Clause 4.6 (failing to maintain respect
and confidence of the veterinary and pharmaceutical professions …... or to
promote the correct use of animal medicines), Clause 5.8 (… no reference may
be made to any individual or official body….) and Clause 8 (…manufacturers
should not include in any announcement or promotional material a reference
to ……..or similar official bodies).
The standard letter used acknowledged that there was no
specific data sheet indication for the use of Nobivac FeLV as a diluent for
Nobivac Tricat, but maintained that specific trial work had been conducted,
that the Respondent was in possession of data (already submitted to the
Veterinary Medicines Directorate) which satisfied the Respondent that there
was appropriate safety and efficacy in cats when Nobivac FeLV is used with
Nobivac Tricat in this way. The letter went on to state that whilst such use
had to be considered as ‘off data sheet’ use, if the reader decided to use
the products in this manner, the Company would provide full technical
support. The letter also asked for its content to be kept confidential at
this stage.
The Respondent’s representatives at the meeting of the
Code of Practice Committee meeting, acknowledged that there had been between
100 and 200 examples over several years where this standard letter had been
used in response to similar enquiries. They also explained that the reason
why there was still, after many years, no Marketing Authorisation from the
VMD for this use, was caused by a bureaucratic complexity reflective of the
different sources of the products and the European regulatory framework. It
did not reflect any problem with the data submitted.
By a majority decision, the Code of Practice Committee
concluded on the facts of this case that the activities complained of did
not constitute “promotion” and therefore there was no breach.
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237. Boehringer Ingelheim Ltd v. Schering Plough
Animal Health regarding Zubrin marketing campaign "Kind to Kidneys"
This case, originally heard by the Committee on 19 March
2004, comprised of one item. The promotional wording objected to: “Zubrin is
the only NSAID licensed for use in dogs with mild renal impairment” and “it
can be used in subclinical cases without causing further renal damage”,
appeared in Schering-Plough Animal Health’s “Are you kind to kidneys” Zubrin
marketing aid ZUB/07/03/000689. The promotion was directed principally to
Vets.
Part A of the case concerned the fundamental issue of
whether it was inaccurate to promote, by use of reference in the EPAR
(European Public Assessment Report) document which indicated no adverse
affects had been found in respect of treatment by Zubrin for use in dogs
suffering mild renal impairment, in the context of it being the only NSAID
licensed for such use, which could only arise from an indication given
within the SPC (Summary of Product Characteristics). Part B of the case
concerned whether it was proper to claim benefits for diseased animals when
the studies referred to only related to healthy animals.
The Respondent’s representatives maintained that the EPAR
was not just a discussion document, but a reflection of the actual thinking
of the European Medicines Evaluation Agency (EMEA) which licensed the
products through a centralised procedure. The Respondent’s representatives
confirmed that the legal licensed indications for the product could only
arise from the SPC.
The Complainant argued that there was a difference
between an absence of a contra-indication and a positive licensed indication
give by the SPC. The Respondent’s response to this point was that the fact
there was no contra-indication within the general licence given by the SPC,
meant that in effect the product was licensed in the manner indicated.
The Respondent’s representatives also stated that there
was no way that a study could be produced involving diseased dogs. because
that was not the standard practice; only healthy animals were used. However,
their view was that the benefit or lack of contra-indication in healthy dogs
was a perfectly reasonable authority to use in the context utilised.
The unanimous decision of the Committee was:-
With regard to part A of the complaint, the Committee
considered that the statement “Zubrin is the only NSAID licensed for use in
dogs with mild renal impairment” was misleading since the SPC contains no
such positive statement as opposed to an absence of contra-indication.
Accordingly the Committee found a breach of Clause 4.3 of the Code.
The Committee also considered that the statement “it can
be used in subclinical cases without causing further renal damage” was not
substantiated. Accordingly the Committee found a breach of Clause 4.5
of the Code.
Having regard to its findings in respect of part A, the
Committee did not consider it necessary to give a separate ruling on part B
of the complaint.
* * *
Case 237/12/03 was referred back to the Committee on
their 21st of May 2004 meeting. The Complainant alleged the Respondent had
breached their Undertaking and three additional items of complaint were
raised:-
Firstly, “Doubly active on pain; uniquely kind to
kidneys”. This was contained in a mailer which was produced prior to the
Committee’s decision being made known to the Respondent, but which had
continued to be used thereafter and in particular, was available at the
BSAVA Congress.
Secondly, there was an oral representation made on the
2nd of April 2004, as reported in the letter of complaint dated 7 April
2004.
Thirdly, there was the new Respondent’s detail aid and
the three issues referred to in that, the first being a repetition of the
concern regarding the wording “uniquely kind to kidneys”, and then two other
matters which constitute the new Case 240/05/04.
The Respondent confirmed that the mailer available at
BSAVA, had been voluntarily withdrawn on 2 April 2004, after consultation
with the Complainant and the Chief Executive (NOAH).
With regards to the oral representation, the Respondent
drew attention to the fact that the person to whom the alleged
representations had been made, was an employee of the Complainant. The
Respondent had checked with the representative in question, who simply could
not recall precisely what he had said.
With regards to the third issue, the Respondent agreed
that although it was clear that Zubrin provided relief from pain, it could
not actually provide a medical response to renal disorder. The Respondent
maintained that no-one would misunderstand the wording, or would be misled
by this. The other query which was raised was did the absence of
contra-indication actually constitute a positive benefit. The Respondent
maintained that they had upheld the spirit of the Code in every sense.
Accordingly, the Committee’s decision was as follows:-
Mailer
1. The Committee noted that the mailer did not contain
either of the statements which the Respondent had undertaken not to use.
2. By a majority, the Committee considered that the
statement "uniquely kind to kidneys" was neither misleading nor
unsubstantiated since Zubrin is unique in not being contra-indicated in
respect of dogs with renal impairment whereas other NSAIDs are
contra-indicated in that respect. Accordingly the Committee found no
breach of clauses 4.3 or 4.5 of the Code.
3. By a majority, the Committee considered that the
statement "Only Zubrin provides ... relief from long term renal side
effects" was misleading in the absence of any reference to the requirement
for special care in cases of marked renal deficiency. Accordingly the
Committee found a breach of clause 4.3 of the Code.
4. The Committee considered that this breach could be
said to be similar to the breach found in Case 237, but noted that the
mailer had originally been prepared prior to its decision in Case 237 and
that Respondent had voluntarily and promptly withdrawn it upon being
notified of the Complainant's complaint and prior to giving its undertaking.
In the circumstances the Committee considered that no further action
was required.
Oral statements
1. The Committee noted that the oral statements
complained of did not include either of the statements which the Respondent
had undertaken not to use.
2. The Committee considered that the statements
complained of did not constitute "promotion" since they had been made in
direct response to a technical question by a Boehringer Ingelheim
veterinarian. The Committee also noted that the Complainant had not
specified why the statements complained of were alleged to be in breach of
the Code or of the Respondent's undertakings in Case 237. In any event, the
Committee considered that the statements complained of were neither
misleading nor unsubstantiated. Accordingly the Committee found no
breach of clauses 4.3 or 4.5 of the Code.
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239. Merial Animal Health v. Pfizer Ltd regarding
Stronghold advertisement
This case, heard by the Committee on 21st May 2004,
involved Pfizer’s advertisement entitled “You won’t find Stronghold in
supermarket trolleys….. Stronghold loves vets, hates Supermarkets” and
comprised of four items:-
1. “POM flea products are already being re-licensed to
sell through supermarkets”. This, the Complainant maintained is misleading
in contravention of Code of Practice Clause 4.3, because only the relevant
regulatory authority, namely the VMD (Veterinary Medicines Directorate) or
EMEA (European Medicines Evaluation Agency), can know (with the company
concerned) when an application for change of legal status is made. #
# Footnote: the VMD would not be involved in a centrally
registered medicine, as the EMEA granted the licence in the first instance.
2. “You won’t ever find Stronghold on supermarket shelves
- EU rules guarantee it*” qualified by the statement “*Under current and
foreseen EU legislation Stronghold with a centralised license can only be
classed as POM.” In relation to these words the Complainant argued that
Stronghold could be found on supermarket pharmacy shelves, and that the
second (qualifying) statement is speculation. Accordingly, it was suggested
the words are in breach of Code of Practice Clauses 4.3 and 5.5. Further it
was argued that as the qualifying statement does not reflect current
knowledge, it is a breach of Code of Practice Clause 4.2.
3. “Can other flea Spot-Ons say the same?”. Here the
Complainant maintained that these words constitute, by implication or
speculation, that by virtue of future changes other products will be found
on supermarket shelves. It was said the words juxtapositioned with the
phrase “hates supermarkets”, implied that products available through
supermarkets are bad, contrary to Code of Practice Clause 6.1, in that it
disparages competitor products.
4. “Will you lose your flea business - is your income
safe?” and “Stronghold - Loves vets, hates supermarkets” were stated by the
Complainant, to incite questions that would be damaging to the industry and
as such would be in contravention of Code of Practice Clause 4.6.
5. Further, it was suggested, that the whole tone and
inference of this advertisement implied that Veterinary Surgeons choose
products on the basis of the financial impact on their business, rather than
medicinal claims and clinical judgement, contrary to Clause 4.6 of the Code.
With regards to the second issue, the Respondent was
asked how it could justify the use of the statement “EU Rules guarantee it”,
bearing in mind that there is nothing by way of direction of prohibition
against applying for a transfer from POM to GSL once, at any rate, that the
product had been proved to be satisfactory for at least 5 years. The
Respondent confirmed that it was theoretically possible to reclassify
Stronghold, but maintained that the nature of the product ensured that this
would never happen in practice, because one of its indications for use was
for treatment of sarcoptic mange, which would require veterinary diagnosis.
Concerning the fourth issue, the Respondent maintained
that veterinary surgeons made their decisions from a variety of viewpoints
and acknowledged that veterinary surgeons would consider what was right for
their financial circumstances, having satisfied themselves that what they
were recommending or prescribing, constituted the best clinical judgement.
Accordingly, the Committee’s decisions were as follows:-
1. By a majority, the Committee was not satisfied that
the statement "POM flea products are already being re-licensed to sell
through supermarkets" was misleading and therefore found no breach
of clause 4.3 of the Code.
2. The Committee considered that the statements "You
won't ever find Stronghold on supermarket shelves - EU rules guarantee it"
and "Under current and foreseen EU legislation Stronghold with a centralised
licence can only be classed as POM" were inaccurate and unsubstantiated
since EU legislation would not necessarily prevent the Respondent from
obtaining reclassification of Stronghold to GSL at least for flea treatment.
Accordingly the Committee found a breach of clauses 4.3 and 5.5 of the
Code.
3. The Committee considered that the statement "Can other
flea spot-ons say the same?" was not disparaging of competitors' products
and therefore found no breach of clause 6.1 of the Code.
4. The Committee considered that the statements "Will you
lose your flea business - is your income safe?" and "Stronghold - loves
vets, hates supermarkets" were not such as to maintain the respect and
confidence of the veterinary and pharmaceutical professions and of the
public since they appealed to veterinarians' financial self-interest in an
inappropriate manner and since they suggested that supermarkets were a less
suitable channel for the sale of flea products than veterinary practices
even if such products had GSL licences. Accordingly the Committee found a
breach of clause 4.6 of the Code.
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240. Boehringer Ingelheim Ltd v. Schering Plough
Animal Health regarding Zubrin advertising "Kidney failure - the silent
killer"
As regards the first issue “uniquely kind to kidneys”,
the Committee came to the same view as indicated in the case linked to 240,
namely 237. Case 240 was also heard by the Committee on 21st May 2004.
Insofar as the issue regarding older dogs against younger
dogs, the veterinary surgeons present on the Committee confirmed that the
only way any form of trial can be used would involve healthy dogs and there
was unanimity that no real breach had occurred.
On the third point there was unanimity that the method
used by way of reference was perfectly acceptable, and indeed, probably the
best possible example of how one should display a qualified reference in
that it was bold and highlighted text, immediately below the claim, and was
clearly visible to the reader.
Accordingly the decision of the Committee was as
follows:-
1. By a majority, the Committee considered that the
statement "uniquely kind to kidneys" was neither misleading nor
unsubstantiated since Zubrin is unique in not being contra-indicated in
respect of dogs with renal impairment whereas other NSAIDs are
contra-indicated in that respect. Accordingly the Committee found no
breach of clauses 4.3 or 4.5 of the Code.
2. The Committee considered that the statement "no kidney
chemistry changes detected" was not misleading and did accurately reflect
the evidence and reasonable opinion since it was reasonable to use data from
a study on young healthy dogs to support a promotion directed at older dogs
with renal disease. Accordingly the Committee found no breach
of clauses 4.2, 4.3 or 5.1 of the Code.
3. The Committee considered that neither the wording nor
the difference in type sizes of the statements "Zubrin is the only licensed
NSAID not contra-indicated in dogs with renal impairment" and "Special care
should be taken when treating dogs with marked renal deficiency" was
misleading or likely to lead to incorrect use of the medicine. Accordingly
the Committee found no breach of clauses 4.3 or 4.6 of the
Code.
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241. Pfizer Animal Health v. Merial Animal Health
regarding Frontline Combo advertisements and brochures
This complaint, heard by the Committee on 16 July 2004,
involved three issues against current advertisements in various veterinary
journals and brochures for Merial Animal Health’s product FRONTLINE™ COMBO.
The specific wording objected to is ‘protects your cat, dog and home’,
‘keeps home flea free’, and ‘prevents the development of eggs. larvae and
pupae’. The Respondent maintained that all the issues identified were fully
supported by the product’s SPC.
Environmental control
Dealing with the first point, the question arose as to
whether or not the product would keep the home ‘flea free’. A number of
points were discussed and considered:-
1. The fact that the product would only be prescribed by
a Veterinary Surgeon and that their advertising to the consumer had the
protection of veterinary surgeon control as regards provision of the
product;
2. Ultimately the product would remove infestation over a
period of time, providing the product was applied on the animal in
accordance with the directions, and that other animals which were not so
treated, were not allowed into the home on a regular basis.
3. The word ‘keep’ implied that the home was already flea
free prior to considerations as to whether the product should be used on an
animal. Nevertheless, there was substantial concern that, particularly in
the context of the consumer advertisement, there could be a misunderstanding
as to whether the product worked environmentally.
By a majority, the Committee concluded that the
statements complained of were not misleading or inaccurate or exaggerated
since Frontline Combo did protect pet owner's homes by preventing the
development of eggs, larvae and pupae from treated animals. Accordingly the
Committee found no breach of clauses 4.3, 5.1 or 5.2.
Larvicidal activity
The second item concerned the penetration of the larvae
as contained in the box in the life-cycle diagram. This wording was directly
adjacent to a picture of a sofa.
By a majority, the Committee concluded that the statement
"(s)-methoprene penetrates larvae to prevent their development in the
environment" was misleading, particularly having regard to its juxtaposition
with a photograph of a sofa, since it implied that (s)-methoprene in
Frontline Combo penetrated larvae directly rather than merely achieving
larvicidal activity by penetrating eggs. Accordingly the Committee found a
breach of clause 4.3.
Development of pupae
As regards to the third issue ‘Frontline Combo prevents
pupae development’ within the same life-cycle diagram:-
The Committee unanimously concluded that the statements
complained of were not misleading, inaccurate or exaggerated since Frontline
Combo did prevent development of pupae from treated animals. Accordingly the
Committee found no breach of clauses 4.3, 5.1 or 5.2.
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245. Intervet UK Limited v. Fort Dodge Animal Health
- promotional activities: Duramune Canine Vaccines
The complaint from Intervet (UK) Limited involved 7 issues against Fort
Dodge’s promotional activities relating to their DuramuneŽ range of canine
vaccines.
The promotional items in question were:-
1. Promotional item 1 contained in letter of Fort Dodge Animal Health’s
Territory Manager:-
“This may cause you to question whether older vaccines are suited
to today’s challenge ……. find out how your patients could benefit from
Duramune protection before it’s too late”.
2. Promotional item 2 contained in power point demonstration used by Fort
Dodge Animal Health:-
The references on pages 2, 3 & 4 to “challenge” in the
context of experiments carried out by Pratelli and others implies that a
challenge experiment was carried out, contrary to fact.
3. Promotion item 3 contained in the Veterinary Media advertisement and
the detailer:-
The use of the greyhound image in the advertisement constitutes “an
imitation of the complainant’s own device, slogan or general layout ..….. in
a way likely to mislead or confuse” contrary to Clause 7.9 of the
Code.
4. Promotion item 4 contained in the Veterinary Media advertisement:-
“Parvovirus has moved on” and “Recent clinical cases in several
parts of the UK serve as a reminder that parvovirus remains a very real
threat to the health and well being of the canine population. Since
parvovirus emerged in the late 1970’s, mutations of the original CPV2
biotype have proliferated worldwide, to the point where the original virus
can no longer be found. It is these newer mutated biotypes, designated CPV2a
and CPV2b, that are responsible for clinical disease throughout Europe1.
Despite this evolutionary change, until very recently all UK vaccines were
based on the apparently extinct original biotype. Now, with the introduction
of DuramuneŽ DAPPi+LC, parvovirus protection has been brought right up to
date. Duramune DAPPi+LC is the only vaccine to include a parvovirus antigen
based on one of the currently prevalent biotypes. This means you can avoid
running the risk of providing what independent researchers have referred to
as less than optimal parvo’ protection. Duramune DAPPi+LC provides the
standard of protection you and your clients expect from a 21st Century
vaccine”.
5. Promotion item 5 reported statement by Representative:-
“…. there have been a few mini outbreaks of parvo up-country in
dogs that have been vaccinated with the Nobi range”.
6. Promotion item 6 contained in the detailer:-
“Why does it matter …..” plus “researchers investigating why pups
with HI titres of 1:160 to 1:320 to CPV2 proved vulnerable to disease caused
by CPV type 2b found that …..”
7. Promotion item 7 contained in the detailer:
“Conclusions” plus “less than optimal protection may
be afforded by CPV2 vaccine (sic)”.
The essential and primary issue comprising the dispute was whether the
message set out in full in item 4, and also behind the message contained in
items 1, 5, 6 and 7 was correct, subsidiary issues were items 2 and 3.
The results of the Committee’s deliberations in respect of each item
were:-
1. By a majority, the Committee found that there had been no breach
of the Code.
2. By a majority, the Committee concluded that the use of the word
"challenge" in the contexts in which it was used in the PowerPoint
presentation was misleading since the Pratelli paper cited referred to
exposure to parvovirus in the field and not to a controlled experiment or
trial. Accordingly the Committee found a breach of clause 4.3 of the
Code.
3. The Committee unanimously found that there had been no breach
of the Code.
4. By a majority, the Committee found that there had been no breach
of the Code.
5. The Committee unanimously concluded that the facts relied upon as
constituting a breach of the Code had not been established and therefore
found that there had been no breach of the Code.
6. By a majority, the Committee found that there had been no breach
of the Code.
7. By a majority, the Committee found that there had been no breach
of the Code.
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247. Intervet UK Limited v. Schering-Plough Animal
Health promotional activities - Procyon range of canine vaccines
This case involved three separate issues of promotion, the first two
contained in a launch advertisement, the third in a detail aid. The
promotional words to which complaint was made were as follows:-
- “Option to boost annually for leptospirosis and parainfluenza”
- “Flexibility and choice in your vaccination protocols”
- Vaccination schedule with revaccination with Procyon Dog DA2PPi/CvL
every 3 years, and vaccinations with L/Pi in the interim years”
The complaint was that all three items were in breach of Code of Practice
Clauses 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) and 4.8 (promotion must not
be inconsistent with the SPC, except that a veterinary surgeon or other
suitably qualified person employed or engaged by a participating company may
in appropriate circumstances give information about off-SPC use in response
to a technical enquiry from another surgeon).
Although the product had an indication for use stating a duration of
immunity of at least 3 years for distemper, adenovirus (CAV1 & CAV2) and
parvovirus, it only provided immunity for 12 months for the other components
in the vaccine, which included canine coronavirus. The promotion referred to
interim boosting in respect of leptospirosis and parainfluenze, but did not
specifically cater for coronavirus.
After discussion, the matter was put to a vote.
By a majority, the Committee concluded that all three items of promotion
in the advertisement and detail aid, the subject of the complaint were
inconsistent with the SPC because the SPC recommends annual booster
vaccinations of Procyon and does not provide for booster vaccinations using
other manufacturers’ products. Furthermore, the items of promotion were not
covered by the proviso to clause 4.8. Accordingly the Committee found that
the items of promotion were in breach of clause 4.8.
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No new cases were heard in 2005.
NOAH Ltd
12 March 2004 (for case 236)
27 September 2004 (for cases 237, 239, 240 and 241)
6 June 2005 (for cases 245 and 247)
21 December 2005 (confirmation of no 2005 cases) |
