2020 cases

Summary of Committee meetings held in 2020

Case No: 302/12/20 Boehringer Ingleheim Animal Health Ltd / MSD Animal Health; Bravecto

Case 302-12-20, brought by Boehringer Ingelheim Animal Health Ltd against MSD Animal Health, involved two items of Complaint relating to promotional material for MSD’s product Bravecto.

The items of complaint were as follows:

Item 1 – The allegation that MSD failed to provide evidence to substantiate the claims of increased owner compliance with Bravecto made in the promotional materials within 5 working days.

Clause 5.1 of the Code was alleged to have been breached:

5.1 Upon written request, a Participant must provide within 5 Working Days of receipt of the written request from a lawfully intended recipient of the Promotion or other participant:

(i) information or data referred to in the Promotion;

(ii) information or data to substantiate any claim in the Promotion 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 time in which substantiation will be supplied.

Item 2 – Owner Compliance claims

2a) Making promotional claims of increased owner compliance with Bravecto based on data which is purchase data.

2b) Making promotional claims of increased owner compliance with Bravecto based on flawed data comparing Bravecto with monthly isoxazolines and parasiticides.

A number of phrases within MSD’s promotional material such as ‘Bravecto increases compliance vs monthly isoxazoline products’, ‘62% increase in dog owner compliance with Bravecto vs other ‘isoxazolines’, and ‘66% increase in cat owner compliance observed with Bravecto vs monthly parasiticides’ were grouped under this item.

The clauses of the Code alleged to have been breached were as follows:

4.3 A Promotion of Animal Medicines must:

(i) be fair;

(ii) be balanced;

(iii) not be misleading (directly or by implication);

(iv) not directly or by implication disparage the products or services of other companies;

(vi) not contain exaggerated claims, all-embracing claims or superlatives of a general nature;

(vii) not state directly or by implication that an Animal Medicine, or an active ingredient, has some special merit, quality or property over other products unless this can be substantiated

4.4 Any information or claim in a Promotion of Animal Medicines must:

(i) be accurate;

(ii) be based on an up-to-date evaluation of all the evidence and must reflect this evidence accurately and clearly;

(iii) be capable of substantiation.

Boehringer Ingelheim presented their case to the Committee:

Regarding Item 1 the Boehringer Ingelheim representatives made the following points:

• Boehringer Ingelheim accepted that MSD had responded to their requests for substantiation within five working days. However, as sufficient detail to understand the aggregated averages and to facilitate a full appraisal of the figures had not been provided, they had been unable to determine that the claims were substantiated.
• They had never requested the raw data, and would have accepted anonymised results, broken down by product.

Regarding Item 2 the Boehringer Ingelheim representatives made the following points:

• Purchase data alone is not sufficient to demonstrate increased owner compliance.
• There are many real-life variables including different owner purchase and administration patterns ranging from 1, 3, 6 or 12 months purchased, prescriptions provided in-practice being fulfilled vs those fulfilled online, pets registering or leaving a practice part-way through the year etc. These variables mean that purchase data alone cannot substantiate the owner compliance claims as purchase cannot be directly extrapolated to compliance and use of the product as per the prescribing vets’ instructions.

MSD Animal Health presented their case to the Committee:

Regarding Item 1 the MSD representatives made the following points:

• MSD responded to each Boehringer communication within a 5-day timeframe as required by the NOAH Code, and the information provided was in their view sufficient to allow verification of the statistics to take place.
• MSD provided the methodology used in calculating percentage increase in compliance as well as tables providing the average months of protection prescribed and purchased for the combined monthly isoxazolines compared with the average months of protection prescribed and purchased for Bravecto.

Regarding Item 2 the MSD representatives made the following points:

• The data belongs to a third-party supplier and MSD are under a non-disclosure agreement not to share the data with any third party. Any anonymised data would still have allowed named products to be identified due to the differing pack sizes.
• The purpose of the studies was to benchmark MSD’s isoxazoline product, Bravecto, against other parasiticides also active against fleas and ticks.
• The reference included on promotional material stated that the results were based on product prescribed and purchased, therefore making the evidence base for any claims clear to the reader.
• Protection cannot be administered if it has not been prescribed and purchased.
• Measuring purchase records is the best proxy for measuring adherence as set out in a paper by Lavan et al from 2017.

Committee Finding

After extensive, in depth discussions, the Committee ruled as follows:

Item 1

The Committee was of the view that the requirement within the clause to provide “…information or data to substantiate…” meant that enough data should be available to enable the requesting party to verify and check the data that has been referred to and relied upon in the promotion. Where this data has been provided by a third party, terms should be agreed to allow for data sharing where it has been requested under the NOAH Code, or alternatively the party should consider whether they should rely on such data to make promotional claims.

The Committee commended MSD for the promptness of their replies to Boehringer Ingelheim and found that although MSD did not intentionally breach Clause 5.1 and it believed in good faith that it had complied with Clause 5.1, MSD had nevertheless breached Clause 5.1.

Item 2

The Committee found that “owner compliance” meant whether or not a parasiticide had been administered to an animal as prescribed. Having made this finding, the Committee held that whilst purchase data showing how many months of protection of a parasiticide that a dog or cat owner had bought (following prescription) in a year may be a reasonable indicator of whether or not a dog or cat owner does administer a product , it is no more than that. The Committee was of the view that there were too many other factors in owner compliance (some examples being the sending of reminders, any seasonal promotions, animals switching product throughout the year or simply a failure to administer a bought product) to claim a direct relationship between owner compliance and the average months of protection prescribed and bought in a year as stated in the promotions.

The Committee also found that the footnote within the various promotions was unclear, referring to “investigation” and “study conducted” when in fact MSD had merely extrapolated the level of owner compliance as being directly related to the raw purchase record data showing the months of protection bought by dog and cat owners following prescription. The promotions were unequivocal and clear about the percentage increase in owner compliance and precise figures were used in those promotions which a reader would take as meaning that there was clear and solid data and research to directly support such claims.

Furthermore, the Committee found that the analysis of purchase data for dog owners was flawed as it failed to take account of the fact that many dog owners were likely to have switched during the period of analysis from one monthly parasiticide which was not included in the purchase data to one that was included. Such meant that the purchase data was likely to have under-estimated the level of compliance by dog owners prescribed monthly parasiticides.

Therefore, the Committee unanimously found that MSD had breached Clauses 4.3(i) 4.3(iii), 4.4(ii), and 4.4(iii) of the Code of Practice.

Undertaking

Following the case MSD were required to sign an undertaking stating the following:

Case No. 302-12-20

1. We acknowledge and accept the decision of the Committee in Case 302/12/20 as set out in the NOAH Code of Practice Committee Decision Notice provided by email on 21 December 2020.

2. We undertake:

a) that, within 5 working days of receipt of a written request for information or data in a Promotion from a lawfully intended recipient of that Promotion or other member of NOAH, we shall provide to the same:

(i) information or data referred to in that Promotion

(ii) information or data to substantiate any claim in that Promotion.

unless there are genuine extenuating circumstances requiring a short extension and in which case an explanation must be supplied within 5 days with an estimate of time as to when substantiation will be supplied.

b) not to market or promote marketing material which claims in substance that owner compliance of dog or cat owners who are prescribed Bravecto is higher (whether by way of percentages or words) than for those prescribed monthly isoxazolines or other monthly parasiticides insofar as such claim is merely based on purchase data which evidences that dog or cat owners prescribed Bravecto bought in aggregate or on average more months of protection in a defined period than those prescribed with monthly isoxazolines or other monthly parasiticides.

3. We hereby give an assurance that we will take all possible steps to avoid a breach of the above undertaking.

Case No: 301/10/20 Zoetis UK Ltd / Ceva Animal Health Ltd; Tulaven® 25

Case 301/10/20 was a two item case, brought by Zoetis UK Ltd against Ceva Animal Health Ltd regarding two claims made in marketing materials for Tulaven® 25. The promotion was emailed to a number of dedicated swine practices in the UK.

The items of complaint were as follows:

• Promotional claim that 99% of users prefer Ceva Layer Anti-shatter (CLAS) vials to glass;
• Promotional claim that the product is eco-friendly and has 33% less impact on the environment.

With regards the first item the clauses alleged to have been breached were:

• Clause 4.3(vii): A Promotion of Animal Medicines must not state directly or by implication that an Animal Medicine, or an active ingredient, has some special merit, quality or property over other products unless this can be substantiated;
• Clause 4.4(iii): Any information or claim in a Promotion of Animal Medicines must be capable of substantiation;
• Clause 5.1: Upon written request, a Participant must provide within 5 Working Days of receipt of the written request from a lawfully intended recipient of the Promotion or other participant:

                (i)            information or data referred to in the Promotion;

                (ii)           information or data to substantiate any claim in the Promotion 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 time in which substantiation will be supplied.

With regards to the second item, Zoetis alleged it breached the above clauses plus Clause 3.1: A Promotion must never be such as to bring discredit upon, or reduce confidence in, the animal medicines industry.

Zoetis presented the following points to the Committee:

• Zoetis first wrote to Ceva on 6^th August, raising a number of issues.
• Zoetis requested the references and information to substantiate items 1 and 2 of the case, within a 5 day timeline as stated in the Code of Practice.
• Regarding item 1, Zoetis had to make repeated requests for the reference document. Some, of the requested information was not provided until 7^th September and when provided it was not the complete requested information and it was in French, not a translated version.
• Now, having seen a translated version, as provided by Ceva for the Committee, Zoetis accepted that Ceva had substantiated item 1, but they had not been able to assess this prior to raising the complaint with the secretary of the Committee as a translated document had not been provided when the complaint was submitted.
• Regarding Item 2, Zoetis stated that the reference supplied, a study by Jacquet, could not be found in the public domain, and upon requesting this from Ceva, Zoetis were told that Ceva did not wish to disclose the requested information. Having now seen an excerpt as part of the case papers being considered by the Committee, they still did not feel item 2 was substantiated.
• For both items 1 and 2, Zoetis believed Clause 5.1 to have been breached.
• In relation to Clause 3.1, Zoetis felt that Ceva had not acted within the spirit of the Code, and that any information and references for their promotional material should be made available in a timely manner upon request as required by the Code.

CEVA presented the following to the Committee:

The Chair confirmed that the Committee did not need Ceva’s position on Item 1 to be addressed as Zoetis had accepted having reviewed the material provided to the Committee ahead of the case that Ceva had substantiated the claim. Ceva were asked by the Chair to address substantiation of the eco-friendly claims (Item 2) and also the fact that they did not provide substantiation in 5 working days following the requests from Zoetis.

• Ceva stated that they hold the NOAH Code of Practice in the highest regard and that staff being on annual leave had caused the delay in the provision of the requested information.
• Ceva shared further details from the Jacquet study and also an External Critical Review of the study by Lanquetin. Ceva maintained that the information they provided from these two documents substantiated the claim regarding the environmental impact of the CLAS material used in their product packaging having less impact on the environment than glass vials.
• Ceva confirmed translated extracts from the Jacquet Study and a Critical Review by Lanquetin were provided to the Code Secretary on 7^th of October in the response to the complaint, but that they had not previously provided these to Zoetis.
• Ceva stated they did not (and still have not) released the full Jacquet report because it included commercially confidential information about Ceva’s processes and supply chains. Ceva accepted that in hindsight, it may have been constructive to state this in the earlier inter-company or complaint correspondence.

Zoetis Reply:

• The references and the English language translations referred to as substantiation for the claims made in the Tulaven® 25 promotion had never been received by Zoetis directly during inter-company dialogue.
• In terms of the full report, Zoetis understood that the reports contained confidential information regarding Ceva’s supply chains but, in their view, a redacted summary should have been prepared and provided to people who requested substantiation.

Committee Decision

Alleged breach of Clauses 4.3 (vii) and 4.4 (iii)

The Committee undertook a detailed consideration of the allegations raised by Zoetis regarding the claims made in 2 Items in Ceva’s promotion for Tulaven ® 25, with Zoetis alleging that both items were in breach of Clauses 4.3 (vii) and 4.4 (iii) of the Code.

In respect of Item 1 – 99% of users prefer CLAS over glass, Zoetis conceded Ceva had substantiated the claim in this Item by virtue of the documents disclosed by Ceva, namely a survey of farmers carried out at the SPACE Exhibition in France.

In relation to Item 2, Eco-friendly for 33% less impact on the environment & Proven eco-friendly, the Committee found, by a majority decision, that this claim had been substantiated and was not in breach of clauses 4.3 (vii) and 4.4 (iii). The Committee considered substantiation by only partial disclosure of part of a report was far from satisfactory.  However, the Committee held that a combination of some of the information from the Jacquet Study and the Lanquetin Critical Review paper, the explanation provided during the hearing and the overview of the methodology used was sufficient to substantiate the use of the phrases to the Committee.

Alleged breach of Clause 5.1

In relation to both items, the Committee was unanimous in finding that Ceva had breached Clause 5.1 of the NOAH Code of Practice, in failing to provide Zoetis with requested information and data to substantiate any claim within 5 working days.

The Committee was dismayed that it had taken so long for the substantiation to be provided. For future reference, the Committee expects that where a Company makes a claim in a Promotion, the document substantiating that claim should be readily available in a document repository, hence the 5 working day rule in Clause 5.1. There is an assumption that the documents substantiating the claim will be readily available prior to the promotion being released. The Committee was of the view that provision of the document is required unless the document is readily available in the public domain or an accessible peer reviewed journal.

In the circumstances where the substantiation is in the form of an internal confidential document, and immediate compliance with Clause 5.1 is not possible, a redacted version of the document should be provided in as short a timescale as possible. The Committee’s view is that it is not necessary to have the substantiation document translated into English as a standard protocol (if it originates in a country where a different language is used) but a translation should be prepared and provided on demand.

Alleged breach of Clause 3.1

This allegation was raised in relation to Item 2 – Eco-friendly for 33% less impact on the environment & Proven eco-friendly. The Committee did not find a breach of Clause 3.1 by Ceva as it was not felt that the promotion or the actions of Ceva, including the breaches of the Code detailed above, did discredit or bring into disrepute the animal medicines industry.

Concluding remarks

The Committee therefore found that Ceva Animal Health Ltd had breached the NOAH Code of Practice for the Promotion of Animal Medicines in relation to both Items 1 and 2 placed before the Committee.

As a result of the Committee’s findings, the Chair concluded it was appropriate for the Chief Executive of Ceva Animal Health Ltd to provide an Undertaking.

Undertaking

Following the case, Ceva were required to sign an undertaking stating that Ceva Animal Health Ltd will comply with Clause 5.1 and within 5 working days of receipt of a written request for information or data in a Promotion from a lawfully intended recipient of that Promotion or other Member of NOAH, provide to the same:

(i) Information or data referred to in that Promotion;

(ii) The information or data to substantiate any claim in that Promotion

unless there are genuine extenuating circumstances requiring a short extension, and in which case an explanation must be supplied within 5 days with an estimate of time as to when substantiation will be supplied.

Case No: 300/01/20 Boehringer Ingelheim / Bayer Animal Health UK; ‘Nexgard Spectra® False Case Reports Sales Activity’

This case was considered by the NOAH Code of Practice Committee on Friday 31/01/20. It involved a complaint brought by Boehringer Ingelheim Animal Health (complainant) against Bayer Animal Health UK (the respondent) regarding statements made to veterinary practices by sales representatives of Bayer UK in a number of sales territories about the efficacy of NexGard Spectra® to prevent angiostrongylosis. The statements referred to false case reports about NexGard Spectra® and its efficacy.  Ahead of the case hearing, it was accepted by Bayer UK that the reports were false and that the statements should not have been made and that there were breaches by their representatives of the following clauses of the NOAH Code:

4.3          A Promotion of Animal Medicines must:

(iv) not directly or by implication disparage the products or services of other companies; 

4.4          Any information or claim in a Promotion of Animal Medicines must:

(i) be accurate; 

11           Sales Representatives

11.2        Representatives must at all times maintain a high standard of ethical conduct in the discharge of their duties.

The Committee was also being asked to consider whether the conduct of the Bayer representatives was in breach of clause 3.1 of the Code;

3.1          A Promotion must never be such as to bring discredit upon, or reduce confidence in, the animal medicines industry;

Committee preliminary discussions

The Chair explained that the Committee must consider whether the activities of the Respondent have brought discredit upon or reduced confidence in the animal medicines industry which is a breach of Clause 3.1 of the Code.

The Chair summarised the Parties’ positions being that whilst the admitted practices were of a serious nature, Bayer UK’s stance was that the sales activity was carried out by a small number of representatives which was dealt with very quickly and that there was no involvement of senior management in the spread of such information.

The Chair directed the Committee to section 4.2 of the Rules of Procedure of the Code dealing with the sanctions that the Committee can consider upon the finding of a breach by the Committee.

The Committee considered the fact that the false reports related to Suspected Lack of Expected Efficacy (SLEE) reports which stated that NexGard Spectra had failed to prevent angiostrongylosis, which it is licensed to prevent. The Committee discussed the expected pharmacovigilance duties for the relevant parties where a veterinary medicine is suspected of not achieving what it is licensed for in its SPC. The pharmacovigilance process is a key aspect of monitoring safety and efficacy of veterinary medicines on an ongoing basis and is important for regulation of veterinary medicines.

The representatives of the Complainant and Respondent then joined the Committee meeting.

Boehringer Ingelheim views on the case (the complainant)

The Complainant explained that the activity related primarily to spoken words and there were no physical promotional materials. The representatives presented an overview of the activity in question, based on the reports Boehringer Ingelheim had received from veterinary practices about what had been said by representatives of Bayer Animal Health about NexGard Spectra®.

The Complainant explained that their investigations into the case reports had confirmed that the reports were untrue.  One report had referred to a dog dying of lungworm when in fact, it had tested negative for lungworm.  Another dog had been reported as dying of lungworm after receiving NexGard Spectra® but it had in fact never been treated with NexGard Spectra®.

The Complainant presented information to demonstrate that veterinary practices were seriously concerned about the efficacy of NexGard Spectra® and that the trust in the efficacy of their product had been undermined.    The Complainant urged the Committee to consider that the damage caused by the activity could have spread wider than the practices where it definitively took place e.g. word of mouth conversations in the veterinary community.  The Complainant also believes this activity calls into question the pharmacovigilance reporting system for veterinary medicines.

The Complainant stated that in their view, a letter (as well as phone calls) sent by the Respondent to correct this false information did not go far enough to repair or limit the damage caused by the activity.  In their view the letter from the respondent did not adequately explain the errors in the case reports, nor explicitly state that the reports were false.

The Complainant explained that they wished to ensure that Bayer Animal Health UK would agree to an undertaking to prevent this behaviour from being repeated and also that Bayer Animal Health UK would take steps to mitigate the damage caused by the dissemination of false information.

Bayer Animal Health UK views on the case (the respondent)

The Bayer Animal Health representatives made it clear that they had taken this matter extremely seriously and that they acted promptly to ensure that the activity was immediately and decisively stopped.  The Respondent stated that they took their membership of NOAH and any alleged breach of the Code of Practice very seriously. The Respondent described the steps that were immediately taken including telling any staff involved to cease such activity immediately and reminding them of pharmacovigilance processes and obligations. They had undertaken further NOAH Code of Practice training of staff, acted promptly to cease the activity and they maintained that no further activity occurred after 19 September 2019.

The Respondent then described the process of investigating the matter, identifying the team members involved (covering four territories of the UK within Bayer’s sales structure) and the practices that may have been affected. It stressed that a very precautionary approach was taken to ensure all practices that may have received the incorrect information were contacted to correct this.

The Respondent stated that their veterinary advisers contacted the practices that had been identified as being in receipt of false information regarding NexGard Spectra® both by phone and following up in writing.  The purpose of the phone calls and letters was aimed at addressing and correcting any reference to the false case reports.

The Respondent also described that once this issue was identified face to face retraining was delivered to the sales representative team, which focused on their obligations and responsibilities under the NOAH Code of Practice.

The Respondent accepted that members of their sales team had acted in breach of clauses 4.3, 4.4 and 11.2 of the Code.  The Respondent denied that there was a breach of clause 3.1 as the activity was not widespread amongst all the Veterinary Business Managers and there was no proof the activity occurred outside of the original geographical area identified.

The Committee decision;

After discussion and deliberation, the Committee decided, by a majority, that the conduct of Bayer UK’s representatives did breach Clause 3.1 of the NOAH Code, which states: “A Promotion must never be such as to bring discredit upon, or reduce confidence in, the animal medicines industry”.

In particular, the Committee found (and it was not disputed) that the statements had been made to several veterinary practices by a number of sales representatives in a number of sales territories and that there was no basis whatsoever for making the statements. The false statements had led several veterinary practices to question the efficacy of NexGard Spectra® and indeed to question whether or not such an indication for use should have been granted by the regulatory authorities.

In the Committee’s view false statements by a NOAH member’s representatives about the efficacy of a competitor product of another NOAH member strikes at the heart of the Code and will inevitably reduce the confidence that veterinary practices have in the animal medicines industry and their representatives.

The Committee was also of the view that Bayer UK, once aware of the activities, had not taken sufficiently effective steps to make clear in correspondence to the affected veterinary practices that the statements of its representatives were false. Whilst letters had been sent to several practices, the letter content was not sufficiently clear in stating that the statements were false and there were no such case reports.

Whilst the Committee accepted that the conduct of Bayer UK’s sales representatives was not sanctioned or approved by senior management, the false statements had the effect of undermining confidence that veterinary practices have in the animal medicines industry. The Committee concluded that this represented a breach of clause 3.1 of the NOAH Code. NOAH members must take responsibility for the conduct of their sales representatives.

The NOAH Code emphasises the “importance in the public interest of providing accurate, fair and objective information on animal medicines so that rational decisions for prescribing” can be made. Ethical promotion of animal medicines lies at the heart of the Code to which all NOAH members are bound.

Regarding remedies, the Committee required the Respondent to give an undertaking to ensure that the activity has come to an end and to prevent any repetition.   The Committee also asked the Respondent to identify the steps they will take to prevent breach of the undertaking.

Finally, the Committee decided that an advertisement should be published in the veterinary press giving a summary of the Case decision.  The Committee considered that there was a real possibility that further practices had been told about the false reports, either by the Respondent’s representatives or by veterinary practitioners who had been told about the false reports by the Respondent’s representatives. There was therefore a need for all veterinary practices to know that the statements were false. The Committee agreed that this advertisement was to be placed in the Veterinary Times and the Veterinary Record by the NOAH Executive as outlined by Rule 4.2 (c) of the Rules of Procedure.

Undertaking:

Following the case Bayer Animal Health UK are required to sign an Undertaking which states the following;

1. We acknowledge and accept the decision of the Committee in Case 300/01/20.
2. We undertake that:
3. We shall not

(a) State that NexGard Spectra® is ineffective at preventing angiostrongylosis;

(b) State to persons that dogs have died from angiostrongylosis whilst being treated with NexGard Spectra®

2. We shall take all reasonable steps to ensure that we do not breach the above undertaking.