Code of
Practice for the Promotion of Animal Medicines
Précis of Report to Chief Executives of Cases in 2003 for Circulation
to Veterinary Press
The Code of Practice Committee met formally in January
and March and informally in August 2003. Two new cases were heard and a
summary of the cases and rulings are given below. An Undertaking has been
received in respect of Case 230/11/02. As the Committee determined there was
no breach in respect of Case 233/02/03, an Undertaking was not required.
Case No. 230/11/02 - Pfizer Limited / Intervet UK
Limited - Bovipast RSP
This case involved two items of complaint.
1. The statement “…massive invasion of bacteria e.g.
Pasteurella that usually kills the animal” was argued not to be
justified by the fact that VIDA 2001 Veterinary Investigations Surveillance
Report 2001 (published by DEFRA), indicated that it is Pasteurella multocida
(against which Bovipast RSP has no licensed claim), which is the most
frequently identified bacteria, whereas the Bovipast licensed claim bacteria
Mannheimia (Pasteurella) haemolytica, only makes up 32% of all pathogens
isolated.
The Respondent sought to argue that their own data showed
that haemolytica was more common and that the critical emphases of the
promotion was the necessity to provide a pneumonia vaccine which protected
against viruses and bacteria, which Bovipast RSP did.
Held: This statement did not reflect
current knowledge since "bacteria e.g. Pasteurella" are the cause of
death in less than 50% of pneumonia cases in calves, and was therefore
in breach of Code of Practice Clause 4.2. Further, the statement
was misleading in the context of the remainder of the advertisement, since
it implied that Bovipast RSP offered protection against a broad spectrum of
bacteria, and in particular Pasteurella multocida, contrary to the fact and
was, therefore, additionally in breach of Code of Practice Clause 4.3.
2. The statement “… it’s a massive invasion of the
lungs by bacteria..…that usually kills the animal” in conjunction with
the phrase “Pity the poor calf whose pneumonia vaccine doesn’t protect
against bacteria” and “…significant extra level of defence, choose
the only pneumonia vaccine to combine both viral and bacterial protection….”
was argued supported a view that any vaccine which does not include
protection against bacteria will not work so well against calf pneumonia,
when there is no evidence to support this.
The Respondent argued that whilst statistical analysis
did not prove Bovipast RSP would be more effective than a viral vaccine in a
head to head trial, as no such trial had been carried out, the product
protected against a wider range of pathogens than a viral vaccine and
produced an additional defence.
Held: The statement “Pity the poor calf
whose pneumonia vaccine doesn’t protect against bacteria” was misleading
in that it implied that Bovipast RSP was more efficacious than a purely
viral vaccine, when there was no evidence to support this, contrary to
Clause 4.3 of the Code of Practice
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Case No. 233/02/03 - Schering-Plough Animal Health /
Merial Animal Health - Promotion of Trivacton 6
This one item case involved a claim that the Respondent’s
representatives were recommending that one dose of the vaccine Trivacton®6
is sufficient to boost immunity in cows previously vaccinated with the
Complainant’s product Rotavec Corona ™. There was no written promotion
involved, but the Complainant relied for evidence on letters received from
the Respondent dated 9 January 2002 and 30 August 2002, when it was stated (inter
alia) that reference can be made to product pharmacovigilance from
European countries where Trivacton 6 has been registered for several years
with a high booster recommendation. Further, it was stated that
“switching from one vaccine to another (for the same disease) during an
animal’s lifetime” when addressed similarly “regardless of host
species and across a range of vaccines, should be possible without any
serius disruption of the recipient’s immune status”. The writer was
unaware of any research data in support, but considered it had become an
acceptable approach in the industry. A similar viewpoint was repeated in the
second letter.
In this particular case the Committee felt the relevant
part of the product’s data sheet (recited below) seemed less than helpful:-
“Boosters: No data has been produced to support the
use of a single dose booster regime. However, experience in the field
suggests that a single dose of the vaccine administered two weeks before
calving may provide enhanced antibody levels in the colostrums against the
component antigens”.
Held: The unanimous view of the Committee
was that it considered that it had not been shown that the Respondent had
promoted Trivactin 6 in a manner not supported by the data sheet.
Accordingly there was no breach of Code of Practice Clauses
4.3, 4.5, 4.6, 5.2 or 14.1 of the Code.
However, it should be noted that oral representations are
as capable of being promotions as written promotions (Clause 1.1 of the
Code).
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NOAH Ltd
12 March 2004 |
