Summary of Committee meetings held in 2020
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 6th 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 7th 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 7th 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.
- 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.
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.
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.
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.
Following the case Bayer Animal Health UK are required to sign an Undertaking which states the following;
- We acknowledge and accept the decision of the Committee in Case 300/01/20.
- We undertake that:
- 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®
- We shall take all reasonable steps to ensure that we do not breach the above undertaking.