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.
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