Code of
Practice for the Promotion of Animal Medicines
Précis of Report to Chief Executives of Cases in 2001 for Circulation
to Veterinary Press
The Code of Practice Committee met in January, March, July, October and
December 2001. Four new cases were heard and a summary of the cases and rulings is given
below.
It should be noted that the Respondent Company in Case 221/5/01, who
was found in breach of the Code, did not return a signed Undertaking. In line with
procedure, the Code of Practice Committee reported this fact to the NOAH Board. This case
was also subject to a Court Hearing and was ruled in favour of NOAH. Norbrook Laboratories
Limited: A Correction and Apology
Undertakings have been received in respect of the remaining three cases
where so required.
CODE OF PRACTICE CASE NO. 215/12/00
Boehringer Ingelheim Ltd complaint against Pfizer Animal Health
Promotional Leaflet: Rimadyl Small Animal Mailer
In this single item case, the main issue was the extent to which the
data sheet and statement ‘clinical trial evidence in dogs and cats’, suggested
"only a single dose of Carprofen is required in the first 24 hours
post-operatively….." justified the promotional words in the mailing sent to
all Vets dated 29 November 2000 "Rimadyl has proven and licensed 24 hour
post-operative analgesia ……..".
The Pfizer representative argued that recent studies carried out
clearly showed a distinction between the depth of pain relief and duration. Published data
provided clear support in relation to cats for the single dose requirement for 24 hours
duration in the case of Rimadyl. There was unpublished data that supported the same
arguments as regards dogs.
He further argued data sheet/SPC was sufficient in its own right to
support the promotion made and that no further substantiation was required. They were
anxious not to provide confidential data to a competitor.
The Committee debated the use of "proven" where the data
sheet / SPC uses the word "suggests". On one hand it was acknowledged that the
whole of the data sheet / SPC could be deemed to constitute part of the licensed
indication. On the other hand, the word "suggests" clearly is less certain than
the word "proven".
As regards not supplying data to substantiate a claim, it was noted,
with some sympathy, that the Respondent had sincerely assumed that their promotion was
justified by the data sheet. However, they had only now supplied additional data which the
Committee needed to study.
The Committee’s interim view was that the data sheet / SPC
did not, by themselves, justify the disputed statement, however, it as agreed to adjourn
the case to the next meeting to give time for further consideration of fresh data supplied
by Pfizer. In the meantime, Pfizer were asked to give an assurance that there would be no
repetition of the promotion.
Continued discussion at March meeting.
Since the last meeting the Complainant had withdrawn the complaint
about cats; but also alleged that a modified Pfizer promotion had breached the assurance
not to repeat the statement.
Having considered the fresh data, the Committee now ruled:-
(a) that the statement was justified and, indeed, that the Data Sheet
did support the statement, thus there was no breach,
(b) that the revised promotion was not in breach of the assurance
given.
The Committee did, however, emphasise the need for parties to supply
data in accordance with the procedural timetable. In this case they did recognise that
Pfizer had initially believed that the Data Sheet justified the statement and hence had
not provided further data, nevertheless, if that data had been supplied in good time, the
adjournment might have been avoided.
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CODE OF PRACTICE CASE NO. 217/01/01
Merial Animal Health complaint against Virbac Limited
'Cyclio' Advertisement & Question/Answer Handout
This case involved two different documents from the same campaign and
with similar phraseology:-
1. Advertisement and Q & A handout: " You suck blood.
You're covered in Cyclio. You lay eggs. You die".
The first issue concerned the recurring wording ultimately stating
‘Cyclio - you die’. The Complainant alleged that this implied there was
adulticidal activity, which was not scientifically correct.
The Respondent’s representatives maintained that the tag line
makes it quite clear that the control is through destruction of eggs and larvae.
The Committee did not agree that in the context of this promotional
wording a reader would be led to the assumption that the product has adulticidal activity.
Accordingly there was no breach.
2. Handout: "Cyclio provides long-term eradication of fleas,
both on your pet and in your home".
The second issue, was the extent to which Cyclio provided a long term
eradication of fleas and, in the advertisement, the promotional claim that treatment using
Cyclio would ‘end re-infestation’.
The Respondent maintained that the treatment would in fact provide long
term eradication and had supplied study data to the Committee. The Chairman asked if this
meant that after 3 months there would be a complete solution of the problem with
eradication or would animal owners have to keep on providing the treatment? The Respondent
said there would have to be a continuation of the treatment. The Committee queried the use
of the word ‘eradication’ which would seem to be an absolute, not supported by
the evidence supplied. The response was that by reference to Dryden ’97, the
treatment would provide 99% reduction/removal of infestation, thus only leaving 1% of flea
adults. It was effectively the same as eradication. The Chairman also questioned the term
‘re-infestation’. The Respondent argued that a reader would understand the
implication of the promotion, would recognise the necessity to keep up the treatment, and
that by so doing there would not be re-infestation.
The Committee held that these promotional words were misleading contrary
to Clause 4.3 of the Code, and constituted an exaggerated claim, contrary to
Clause 5.2 of the Code. This was because the treatment with Cyclio will not of
itself eradicate fleas on the pet or in the home; will only eliminate eggs and larvae.
3. Advertisement: "putting an end to re-infestation".
The Committee held that these promotional words were misleading contrary
to Clause 4.3 of the Code, and constituted an exaggerated claim, contrary to
Clause 5.2 of the Code, because the treatment with Cyclio will not of itself put
an end to re-infestation of fleas. Animals may become re-infested through contact with
other animals and/or other locations, bringing fleas back into the home. Indeed, the
Committee noted that this fact is acknowledged to be the case by the Respondent in one of
the answers in the Q & A handout.
4. Q & A Handout: Omissions of data required by Code of Practice
Clause 7.2
Finally, there were the admitted breaches of Code of Practice clause
7.2. in the Q & A Handout. The representatives admitted and apologised for the error
in not complying with clause 7.2 in the Q&A handout.
As this part of the Complaint was admitted by the Respondent, the
Committee noted the breach of Clause 7.2 . The Respondent's expressions of
regret and assurances that the error would not be repeated were also noted with
appreciation.
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CODE OF PRACTICE CASE NO. 221/5/01
Pfizer Limited against Norbrook Laboratories Limited
Noromectin "Trust Noromectin® The No Risk Policy" advertisement in Farmers
Weekly
Norbrook Laboratories
Limited: A Correction and Apology
The single issue in this case was the statement in the advertisement
"There were those who thought they had cover against all parasites affecting their
animals at pasture for eight weeks - they were wrong!".
The Complainant contended that the advertisement wrongly seeks to
suggest the licensed indication of Dectomax is false, and that this is contrary to Clause
5.5 in that the comparison made is not factual, fair or capable of substantiation: or
would mislead the reader by distortion of undue emphasis: or disparages the Dectomax
product contrary to Clause 6.2. It was also contended to be contrary to Clause 4.5 of the
Code of Practice Committee which provides that all information included in promotional
materials be capable of substantiation, and substantiation must be provided without delay
in response to enquiries.
The Respondent argued that the message given by the advertisement was
not intended to be understood to refer to Dectomax, nor would it be so understood. The
contention was that the advertisement related to their own product (Noromectin). However,
even if a reader understood the advertisement to be referring to Dectomax, then the
statement is not in fact false, because the licensed indication of Dectomax does not in
fact provide cover for all parasites at eight week's dosage duration.
After lengthy discussion, the unanimous decision of the Committee was
that the reader would understand the promotion to be referring to Dectomax because of the
reference to 8 weeks. Further, the promotion would be understood by the reader to refer to
all relevant parasites affecting cattle at pasture. The promotion disparaged Dectomax by
implication, contrary to Clause 6.1 of the Code of Practice, as it would
cause such readers to have less confidence in the licensed claim regarding the 8 week
Dectomax dosing regime. Given such a clear breach in the view of the Members of Clause
6.1, it was considered both inappropriate and unnecessary to consider further
whether there was a breach of Clause 5.5, or for that matter, Clause 4.5.
Code of Practice for the Promotion of Animal Medicines
Statement by the Board of NOAH Ltd
On Thursday 17 January 2002 the Board of the National Office of Animal
Health Ltd (NOAH) met to consider a Report from the Code of Practice Committee, sent in
accordance with Articles 17, 18 and 19 of the Constitution of the Code of practice
Committee. The Report concerned Case 221/5/2001, a complaint by Pfizer Ltd about Norbrook
Laboratories Ltd's (Norbrook) advertisement for Noromectin
The Board noted that:-
- On 26 July 2001 the Committee, under the Chairmanship of Mr. David Kitchin QC, heard
case 221/5/2001 and found the advertisement in breach of clause 6.1 of the Code ("the
products and services of other companies should not be disparaged either directly or by
implication").
- In accordance with article 15(i) of the constitution, Norbrook were required to sign a
form of undertaking to comply with the ruling of the Committee that the advertisement
should discontinued. The Board notes with regret that no such undertaking has been
received.
- Norbrook resigned from membership of NOAH on 10 August 2001, and their period of Notice
ended on 10 February 2002.
This statement is issued by the Board of NOAH in accordance with
article 21a of the Constitution of the Code of Practice Committee.
RR Cook, Company Secretary
J McNally, Chairman
NOAH
01.02.02
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CODE OF PRACTICE CASE NO. 222/5/01
Norbrook Laboratories Limited against Pfizer Limited
Advertisement for Dectomax Pour-On and Injection : "Dectomax long action for the
start they deserve": Farmers Weekly
This case involved three issues:-
- "Dectomax gives season long protection against worm scours and lungworm
………." which, it is said, exaggerates the capability of the product, in
that, for example, fasciolasis may need a third party product addition
- "……. for just £3 per head" is misleading, as it does not take into
account variation in body weight, which again, may need a third party product and is
contrary to the Clauses set out above.
- "A recent study has shown that immunity to lungworm can develop even while Dectomax
is still working", as to which it is said, because of the nature of the study
referred to, it is not clear that this has regulatory authority, and in any event it is
not an aspect that relates to Dectomax and is contrary to Clauses 4.6 and 5.1.
The Respondent's response is that the claims are consistent with the
Data Sheet and clinical studies. Fascioliasis does not cause scour. Season long protection
is effectively supported by the Data sheet and by clinical studies. £3 per head is based
on optimum weight which is in fact supported by the data and the footnote gives an
explanation
The Committee, by a majority, determined that the unqualified statement
that Dectomax gives season long protection against lungworm was not wholly accurate and
balanced, in breach of Clause 4.3 of the Code of Practice, in that
nowhere is the qualification expressed which appears in the Data Sheet that "due to
the unpredictable nature of lungworm epidemiology, clinical signs of lungworm disease may
on occasion be seen, particularly towards the end of the grazing season, if the season is
long. If this occurs cattle should be further treated against lungworm".
In respect of the two other issues, namely, the "£3 per
head" item and also the further statement relating to a recent study showing that
immunity to lungworm can develop even while Dectomax is working, the unanimous decision of
the Committee was that there was no breach.
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NOAH Ltd
3 December 2001 (cases 215 and 217) and 26 July 2002 (cases 221 and 222) |
