Precis of Committee meetings held in 2016
- 293: Zoetis UK Limited / Merial Animal Health: Nexgard® and Nexgard Spectra®
- 294: Boehringer Ingelheim / Elanco Animal Health
Case 293/07/16: Complaint by Zoetis UK Limited against Merial Animal Health: Nexgard® and Nexgard Spectra®
The Committee found that items 2 and 4 of this complaint were in breach of the Code.
This case involved a complaint brought by Zoetis UK Limited against Merial Animal Health concerning the latter’s promotion of NexGard® and NexGard Spectra® to the veterinary profession via telephone conversations and webinars from February 2016. It should be noted that the view of the Committee was in relation to corporate behaviour rather than individual account or technical team personnel.
The Chairman summarised this 4 item case by reference to the promotional materials to which the complaints were directed, and the SPC, the products being a tablet parasiticide which in the case of the monovalent product NexGard® had licensed indications of: flea killing effect induced in 2 hours; flea curative efficacy – 100% in 6 hours; and tick curative efficacy in 12 hours and persistent efficacy in 24 hours for 4 weeks against Ixodes ricinus ticks. However in the case of NexGard Spectra® (which was a bivalent product), its SPC indicated it being licensed for flea and tick control in dogs, but without the specific indications concerning speed of kill and efficacy of its sister monovalent product.
The first item constituted the Complainant’s argument that as these indications were not in the SPC for NexGard Spectra®, the Respondent’s promotion of that product as having such indications was in breach of the Code. The Respondent’s justification for such promotion was that the indications in question simply constituted the minima required to secure a licence for flea and tick control in dogs, and that where a product contains an active ingredient which has such benefits, it was justifiable to promote those benefits where that active ingredient constituted part of the product.
The Committee’s attention was drawn to the letter of complaint of the Complainant, the relevant part being recited below:
“as such, these three statements for speed of efficacy in relation to fleas and ticks context the brochure mislead the reader to believe they are licensed claims for NexGard Spectra “
Moving on to the second item, the Chairman introduced the issue as being promotional claim, simply a promotion for NexGard Spectra® as providing protection to dogs against lungworm, which is not an indication within the SPC. This promotion was in a veterinary practice website, wherein it was suggested that such a licence was expected to be granted in the future and it was believed that this information had come from a Merial company employee. A member emphasised that in his view this was an extremely serious allegation, which, if established, would mean deliberate promotion of an off label use of the product which could lead to a breach of the Veterinary Medicines Regulations with the potentially serious consequences that implies.
In relation to item 3, this concerned a letter from a practising veterinary surgeon. A discussion ensued, which (limited to the promotional claim that the product was effective against lungworm) raised significant concerns as to what the Respondent sales teams may have been representing, whilst the same time recognising that the letter had certain inconsistencies, of concern to a number of members. More than one veterinary committee member emphasised the very serious consequences for an industry employed veterinary surgeon, if these allegations were found to be established.
As regards the fourth item this raised the issue of whether the promotional words in question and approach taken by the Respondent in intercompany correspondence brought the industry into disrepute and/or constituted a failure to maintain a high standard of ethical behaviour. It was recognised that this item and complaint constituted very serious allegations, which would require the Committee to consider that the breach of the Code or conduct of the party concerned was of a serious nature.
The parties’ representatives were invited to join the Committee.
Item 1 – following questions by the Chairman, the Complainant’s representatives explained that their concern, was that to get the indications for efficacy, additional trials had to be performed which their product had gone through and it was unfair that a competitor should be allowed to make the same claims when no such additional test for the Respondent’s product had taken place. It was emphasised that there was no complaint that the product did not in fact possess such indications; the complaint was that it was not licensed for such indications. The Complainant’s representatives emphasised that it was dangerous to presume that a bivalent product, which contained an active ingredient, which had certain indications, would necessarily mean that it was appropriate to assume that product would have the same degree of indications, when the indications were not specifically licensed for that product. In the view of the Complainant, it was wrong to presume the same degree of efficacy would apply to the bivalent product, which contained as part of its content the active ingredient that constituted the monovalent product, which active ingredient in the monovalent product was licensed with those indications.
Item 2 – the suggestion it was anticipated that the product would be granted a licence for lungworm protection, the Complainant’s representatives emphasised that they had no complaint against the stated policy of the Respondent from its head office, but suggested that the promotion in question disclosed an unacceptable behaviour by the Respondent’s representatives or agents in the field.
Item 3 & 4 – the Complainant’s representatives stated that this was the “last straw” in terms of what they considered to be a very serious breach or breaches of the Code by agents of the Respondent which constituted unethical behaviour and thereby would bring the industry into disrepute, which constituted the fourth item.
The Chairman and members of the Committee closely questioned the Complainant’s representatives as regards the letter received by Zoetis from the practising veterinary surgeon, in particular drawing attention to:-
(a) The reference to “10 times overdose of the active ingredient” which made little grammatical sense (something is either an overdose or it is not) but does make sense if what was said was “10 times over the required dose”; whereas, the practising veterinary surgeon also referred to a phone call with Merial concerning Trocoxil, where he refers to an “overdose” giving it a long duration of action i.e. he understood that a dose over the required amount was not necessarily unsafe but merely gave a long duration of action. However, the practising veterinary surgeon said that such put him off from using the product which seemed inconsistent.
(b) If the letter was to be taken at face value, the practising veterinary surgeon had discovered that NexGard Spectra® did not have lungworm activity, having been led to believe by “Merial” that it did. Yet, despite that, quixotically, the practising veterinary surgeon said that he was now reluctant to use Zoetis’s products, which also seemed inconsistent.
(c) The remark that “Merial” had said that Simparica had “significant neurological side effects” at an overdose of 3 x normal dose could easily have been checked as being false if the practising veterinary surgeon had checked the SPC for Simparica which refers to there being only mild, transient neurological effects at a 3 x normal dose. However, notwithstanding that, the practising veterinary surgeon had shown that he was prepared to check the SPC for NexGard Spectra®, since he did check that NexGard Spectra did not have a licence for lungworm.
(d) The reference to Merial having exposed “hidden facts” concerning Zoetis, when in the previous paragraph, the practising veterinary surgeon had discovered that what he had been told by Merial about NexGard Spectra® having a licence for lungworm activity was false.
In response, the representatives emphasised that the allegations were very serious and they stood 100% behind any investigation. They were not suggesting that the Respondent’s representative referred to by the practising veterinary surgeon was deliberately telling untruths but they had raised this complaint “to ask questions”.
The Chairman then invited representatives of the Respondent to give their presentation.
Item 1 – there was no statement that the claims were inconsistent with the SPC. The fact that the indications were confirmed in one product but not in another product constituted justification given the same active ingredient. Under close questions from both the Chairman and members, the representatives acknowledged that it was important to their company to get the product “into the market” as quickly as possible and that was the reason why the further testing to establish specifically the indications that the monovalent sister product (NexGard) had, were not undertaken. They suggested that in reality those circumstances in question were clearly referenced.
Item 2 – the representatives emphasised that they received a lot of questions regarding the efficacy of the product against lungworm and that unfortunately the particular comments made had taken the speaker by surprise. They had no knowledge of the website prior to receipt of the complaint. They took steps to have the claim removed. On questioning from the Chairman, what would be the response of Merial if a veterinarian telephoned the Respondent about NexGard Spectra’s ability to be used against lungworm, the response would be and had been that there were studies showing its efficacy for lungworm but that such use would be off-license or ‘cascade use’ of the product.
Item 3 – in response to a question from the Chairman, it was acknowledged that the gentleman in question was one of the Respondent’s veterinary surgeons and had been employed by them for some 2 years. They were asked if the Respondent took and kept appropriate records of questions of a technical nature being raised and the responses provided; the representatives were not able to confirm that any such system existed. They took the view that the practising veterinary surgeon had mis-recalled a number of the allegations made in the letter.
Item 4 – the representatives emphasised that their company took the Code extremely seriously as they did to any circumstance which could constitute a failure to maintain a high standard of ethical behaviour and they rejected fully any idea that there had been deliberate behaviour or promotion which would justify such claims being made against the company.
In reply, on being invited to make brief comment, the Complainant’s representatives emphasised the long period of inter-company discussion, but notwithstanding that, the continuing failure to accept breaches of the Code had taken place, which was part of the concern they had relating to both the issue of unethical behaviour and bringing the industry into disrepute.
The presentations having been concluded, both parties representatives were released by the Chairman, who noted the excellence of their respective presentations.
The decisions of the Committee were as follows: –
ITEM 1 “Promotion of efficacy and speed of kill against fleas and ticks claims for NexGard Spectra which are not present on their SPC”
In relation to this item the unanimous decision of the Committee was that the specifying of speed of kill and thereby efficacy of the product was not inconsistent with its SPC, because the SPC does not make any express or implied representation as regards speed of kill. Whilst the Committee accepted that speed of kill could be the subject of a licensed claim, it did not follow that the absence of such a claim in the SPC meant that such a non-licensed claim was inconsistent with the SPC. Further, in the Committee’s viewpoint, this item would not mislead the reader to believe that they were licensed claims. The Respondent had made no express claim that it was a licensed claim and in the Committee’s view, the reader of the item would not assume (and no evidence was provided that he or she would assume) that such a claim was a licensed claim. Accordingly, the promotion did not breach Code of Practice Clauses 4.3 (iii) or 4.3 (iv).
By reason of the above matters, and the narrow nature of the allegation of whether it was misleading, the Committee makes no finding at all as to whether or not the promotional claims as regards speed of kill contained a claim as to some special merit, quality or property over other products, and/or whether such claims were or were capable of being substantiated. The letter of complaint made no such allegation (the proper grounds for that being Code of Practice Clauses 4.3(vii) and 4.4 (iii)). Accordingly, the Committee did not make any decision on whether the pharmacological properties of the monovalent parasiticide NexGard® as regards speed of kill can be used to substantiate the speed of kill properties of the combination parasiticide product NexGard Spectra®.
ITEM 2 “Continued promotion of a lungworm claim for NexGard Spectra where no such claim is listed on the SPC”
The Committee, by a majority decision, decided that in essence, taking all the evidence in the aggregate, the Respondent had been promoting an off-label use of NexGard Spectra®, contrary to Code of Practice Clauses 4.3 (xi), in being contrary to the VMD regulations; 4.4 (iv), in being inconsistent with the SPC for the product; 4.3 (iii), in being misleading; and 4.4 (i), in not being accurate. In particular, the Committee took into account that (a) the statement on the veterinary practice website that NexGard Spectra “contains an ingredient which kills lungworm and will soon be licensed for this as well” was likely to have come from an employee of the Respondent (the Committee noted that the website positively advertised that Nexgard Spectra could be used as a single product which controls fleas, ticks and lungworm) (b) the webinar website Q&A session (which the Committee recognises may have been an unfortunate error) wherein the Merial representative said “You can use a product that is indicated for lungworm alongside Nexgard” was indicative of a culture within the Respondent to suggest that NexGard Spectra could be used against lungworm – in particular because (c) in answers given by the Respondent’s representatives at the committee meeting to questions from the Committee concerning what the response would be if a veterinarian telephoned the Respondent about NexGard Spectra’s ability to be used against lungworm, the response would be and had been that there were studies showing its efficacy for lungworm, but that such use would be off-licence. In the Committee’s view, the totality of the above information indicates that the company was in substance promoting off-label use.
The Committee was of the strong view that any form of promotion of a product which is off-label, whether expressly or implied, by suggesting (a) that it may be licensed soon, or (b) that it has been found to be efficacious for off label use, is strongly to be discouraged, unless it complies strictly and genuinely with the limited exception provided in clause 4.4 (iv). This exception only applies where information concerning off label use is given by a veterinary surgeon or other appropriate qualified person employed or engaged by a participant company in response to a technical enquiry from another veterinary surgeon, where such information could assist the prescribing veterinary surgeon with appropriate use of the ‘Cascade’, the informant from the participating company being fully satisfied by questioning of the enquirer that the proposed use would be within the exception and (where necessary) use of the Cascade. The Respondent did not seek to justify its conduct by reference to Clause 4.4(iv) and in any event, the Committee in this particular case was not satisfied that that exception applied, taking (as stated above) the evidence in the aggregate, and bearing in mind that in this particular case, prescribing the product (as a result of any such advice) would be likely to breach the Cascade requirements which governs veterinary surgeons.
ITEM 3 “Promoting Nexgard by making disparaging claims about Zoetis products and those of another manufacturer”:
- Bravecto® was a 10 times overdose of the active ingredient;
- Simparica® can cause significant neurological side effects at a relatively low overdose (3 x normal dose);
- informed a vet that a dog had died during the clinical trials of Simparica®, but that Zoetis had not published this information;
- stated that NexGard® is, in essence, much safer than Simparica®;
- NexGard® is the equivalent of Advocate®;
- commented that Trocoxil® is an overdose in much the same way that Bravecto® is.
The Committee found this a very difficult issue to decide, in particular for the following reasons: –
- neither the practising veterinary surgeon nor the person who had spoken to him were available for questioning;
- the Respondent has not provided any statement directly from the veterinary member on their technical team, although recognising this information was important by purporting to provide a précis;
- the Respondent’s failure to have a formal recording system to cater for technical questions being made of their veterinary surgeons, particularly in the context of any use of that company’s product being preferable to competitor products;
- the oddities of the letter from the practising veterinary surgeon including the four recited elements set out above.
- The Committee considered it highly improbable that a highly trained veterinary surgeon in the technical department of a participating company would make such disparaging remarks, particularly when: there is unlikely to be any direct financial incentive for him to do so; the claims could easily be found to be false; and when there are potentially very severe consequences to that veterinary surgeon as a result, including being struck off the RCVS register.
The Committee, on a majority vote, therefore found the allegations not proven. In particular, the Committee felt the most likely explanation was that the practising veterinary surgeon’s memory was at fault when recalling certain statements made by the Merial vet e.g. “10 times over [normal] dose” as opposed to “10 times overdose”. In particular, the Committee noted that the allegations made were of a serious nature and that by reason of such, it was not right to make findings of breach where the Committee was not confident about the quality of the evidence relied upon in support of such allegations.
ITEM 4 “That the events and behaviour of the past 3 months, when viewed as a whole , reflects conduct which falls short of the high ethical conduct expected of NOAH members and is outwith the spirit of the NOAH Code”
Whilst not going so far as to consider there was a breach of Code of Practice Clause 3.1 in bringing the industry into disrepute, the Committee did conclude that sales teams and technical representatives of the Respondent, in promoting an off label claim for use of NexGard Spectra® against lungworm, did fall short of the high standards of ethical conduct required under Clause 11.2.
The primary reason for this was that the conduct of the Respondent, when faced with enquiries about whether NexGard Spectra could be used for lungworm control, and knowing that the product did not have a licence for such use, suggested a culture within the Respondent of suggesting or implying that it could be so used. In particular, the Committee were extremely concerned that the Respondent’s personnel either did know or should have known that the promotion of such use would be contrary to the Veterinary Cascade system. In coming to its decision, the Committee had regard to Guidance Note 5, with the detailed approaches that should be taken in relation to responses to technical enquiries.
The wording of the Undertaking is:-
Case No. 293/07/16
- We acknowledge the decisions of the Committee in Case 293/07/16 as set out in your letter of 19 August 2016.
- 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 undertake not to:-
(a) Promote NexGard® or NexGard Spectra® either expressly or impliedly as being suitable or appropriate for control against lungworm until and unless it has such licence for such.
(b) Promote NexGard® or NexGard Spectra® either expressly or impliedly as having a licence for control against lungworm,
unless (in either case) such amounts to the mere provision of information within the circumstances set out in the exception in Code of Practice Clause 4.4 (iv).
- We hereby give an assurance that we will take all possible steps to avoid a breach of the above undertaking.
The Committee found that there was no breach of the Code of Practice for this Case.
The Chairman introduced this 4 item case in relation to the Respondent’s promotional materials for Fortekor® Plus to the veterinary profession:
Item 1 – the use of an asterisk in place of the full licensed indications within five publications, namely: Fortekor® Plus press information brochure; Fortekor® Plus dosing chart; Fortekor® Plus competition card; Fortekor® Plus pop-up stand; and Fortekor® Plus BSVA stand TV display.
Items 2 and 3 – the use of the words “simplifies” in relation to cardiac dosage regimes and treatment, “simplify” in relation to treatment.
Item 4 – the use of the statement “easy to give” in the product competition card and press information brochure, it being suggested that there was no evidence provided to support such claims and that the tablets are not reduced in size compared to monovalent products such as Vetmedin.
In relation to item 1 the Chairman drew attention to the Complainant’s concern that by not setting out the complete indications for the product, but instead relying on an asterisk, there was a danger that the reader would not appreciate that Fortekor® Plus can only be used for dogs whose clinical signs are successfully controlled by administration of the same doses of the individual components (Pimobendan and Benazepril hydrochloride) given concurrently. Further in terms of administration. Fortekor® Plus is a fixed combination product which is only be used in doses which require both active substance to be administered concomitantly at the fixed dose. Additionally scientific advice recited Pimobendan and Benazepril are also licensed as individual products: Vetmedin® and Fortekor® respectively. He drew further attention to the licensed Fotekor ® dose at 0.25 – 0.5 mg/Kkg/day but can be doubled if considered clinically appropriate by a veterinary surgeon. In the case of Vetmedin the licensed dose is 0.2 – 0.6 mg/kg/day with a preferable daily dose of 0 .5 mg/kg/day. The Complainant maintained it was commonplace in treating a dog with congestive heart failure (CHF) to use the standard/preferred daily doses which cannot be achieved by using FortekorPus®, which means that product is not suitable for the majority of dogs with CHF. The Chairman referred this issue to the veterinary members. The general view expressed was that the promotional material is clearly stated as being a combination product. Even if the asterisk was not noticed the product being such a combination product would, to any responsible veterinary surgeon, be recognised that this can only be really useful having seen that CHF has progressed – the fixed dose ratio 2.1 is simply a conveniently expressed ratio which has no particular merit. In deciding appropriate treatment, that has to be arranged to cater for the particular requirements of the particular dog. Veterinary surgeons could be assumed to understand this.
In relation to items 2 and 3 it was generally considered (subject to hearing the presentations) that inevitably anything which reduces the number of tablets to be administered must make treatment simpler or simplified.
In relation to item 4 it was acknowledged that the active ingredient of benazepril had an unpleasant bitter taste for dogs and inevitably, as the product had a masking taste to cater for this, it would make the tablet easier to administer. One member pointed out that “easy to give” was to be preferred to “easier to give”, as the latter implies a comparison, when the former does not necessarily do so.
The parties’ representatives were invited to join the Committee. The Chairman introduced himself and the Committee and set out the procedure, following which the Complainant’s representatives commenced their presentation.
As regards item 1 they emphasised that any CHF programme had to be in two phases such that doses cannot all be applied in the same proportions. In their view it cannot be assumed that all veterinary surgeons or technicians would have the necessary knowledge or experience to understand fully the issues referable to CHF and when it is sensible to use Fortekor® Plus and when it is not, without having the indications clearly stated. The Chairman closely questioned this argument, seeking clarification as to why the Complainants would not appreciate that this was a combination product, which the promotion did make clear, and thereby would understand the necessity to take this into account
On items 2 and 3 the representatives emphasised the fact that there were other tablets on the market that were of the same size as this product and that accordingly, in their view, this product was not more simple to apply. The Chairman questioned the representatives as to why they felt that it was not simpler to administer one tablet rather than two, to which the representatives conceded that was the case but that in their view this only served to emphasise the dangers of the simplification in the context of the problems of assuming this product was appropriate in all cases of CHF.
Likewise the representatives maintained that the promotional claim that the product is “easy to give” could not be substantiated by the evidence. Again they were questioned by the Chairman and Members, specifically on whether they disputed that Fortekor Plus did mask the bitter taste of Benazepril, which they accepted that that was indeed the case, but other products also had taste masking and in their view the product was not therefore easy to give, in the sense that others were no less easy to give. Questions were also raised as to the proportions of vets accepting a fixed dose ratio.
The Respondent’s representatives were then invited to make their presentation, which commenced countering the four elements of complaint by firstly fully accepting that CHF was a progressive dynamic disease, involving differing forms of treatment, depending on the particular dog being treated.
The Chairman raised the issue of the ratio of 1:1 (benazepril:pimobendan) being more frequently used than the product’s fixed 2:1 (benazepril:pimobendan) ratio, to which the representatives maintained there was no absolute in this area, and that the product had its place in treatment, when appropriate.
Returning to the specifics of the complaint and item 1, the representatives maintained that, given the particular promotional forms, there was no necessity to recite the SPC indications in full, and use of the asterisk in that context, where there were clear references providing full data, was perfectly acceptable. The terminology using ‘simpler’ or ‘simplified’ was likewise entirely justified, within the contexts used and it was a fair statement of fact that the well- established masking technology against the bitter taste of one of the active ingredients, inevitably made the product easier to administer.
A member asked if it was not mistaken to promote the product as being suitable for all dogs on the first page by use of the asterisk where the references were elsewhere in the document; to which the representatives insisted that the references made it clear this did not promote the product in this way and that there was no need to have the reference on the first page, given the readership was directed to the Veterinary profession.
In further response, the Complainant’s representatives maintained strongly that in their view the promotions gave a dangerously misleading impression that the product could be used for all dogs suffering from CHF.
The parties’ representatives were thanked by the Chairman for their excellent presentations and released from the meeting.
After further discussion the unanimous view of the Committee was:-
ITEM 1 “positioning of Fortekor PLUS – asterisk used in place of the full licence indication in five publications, namely: Fortekor PLUS information brochure; Fortekor PLUS dosing chart; Fortekor PLUS competition card; Fortekor PLUS pop-up stand; and Fortekor PLUS BSAVA stand TV display”
The complaint was that this item implied (by not disclosing the full licence indication next to the slogan rather than by way of an asterisk) that the Fortekor Plus was suitable for all dogs. The Committee does not consider the promotion, in making use of an asterisk, implied that Fortekor PLUS is licensed and suitable for all dogs. In particular, the Committee took the following points into account:-
(i) The promotional slogans used (eg Introducing Fortekor Plus – Easing compliance in congestive heart failure) would not be read by veterinary surgeons as implying that it was suitable for all dogs. It did not say so expressly and as regards whether it so implied, veterinary surgeons were aware that invariably, CHF animal medicines were not appropriate for all dogs and would read the slogans and promotional material accordingly.
(ii) The asterisk can be easily seen by the veterinary surgeon reader (to whom the promotion was directed). Veterinary surgeons are used to reading beyond slogans and would often look at the information referred to by an asterisk.
(iii) Veterinary surgeons are used to looking, via asterisks, for SPC indications in promotional materials and not seeing them set out in extenso adjacent to promotional slogans or straplines.
Accordingly the Committee found no breach as alleged of Code of Practice Clauses 4.3 (i) to (iv); 4.3 (vi) (vii) and (xi) or 4.4 (i)-(iv).
ITEMS 2 & 3 “Use of statements “Simplifies Cardiac Dosage Regimes”; Simplify Treatment” and “Simplifies Treatment”
The Committee considered that, within the context of the promotional material being directed to veterinary surgeons which was concerned with taking one tablet as opposed to two tablets, the meaning of such statements would be taken as implying that taking one tablet (which combined two active ingredients) was simpler and easier than taking two separate tablets, each containing one active ingredient.
Given such, the reader would not be misled by the statements, as it is a self-evident truth (which in any event was not disputed by the Complainant and was supported by the accompanying scientific papers) that giving to a dog one tablet consisting of two active ingredients made administration simpler than having to give two tablets.
Accordingly, the Committee found no breach as alleged of Code of Practice Clauses 4.3 (i) to (iv); 4.3 (vi) (vii) and (xi) or 4.4 (i)-(iv).
ITEM 4 “use of the statement : “Easy to Give” in the Fortekor PLUS® Competition Card and Fortekor PLUS® Vet Information Brochure:
The complaint here was that “easy to give” supported the “desired positioning” that Fortekor Plus was suitable for all dogs and that the tablets are physically easy to administer.
The Committee noted that in both cases, the “easy to give” strapline was used in the context of material stating that Fortekor Plus tablets were flavoured and incorporated Fortekor Plus taste-masking technology. Accordingly, the Committee’s view was that the veterinary surgeon would understand the statement to mean that a dog was more likely to accept and swallow a tablet that masked the bitter taste of benazepril, one of the two active ingredients in Fortekor Plus.
The Complainant accepted and did not dispute that the taste-masking technology of Fortekor PLUS® did mask the bitter taste of benazepril. Accordingly, given such a concession, the Committee considered that Fortekor Plus would be easier to give to a dog who would be likely, in the absence of such taste-masking technology, to reject the tablet due to the bitter taste of benazepril.
Accordingly, the Committee found no breach, as alleged, of Code of Practice Clauses 4.3 (i) to (iv); 4.3 (vi) (vii) or 4.4 (i)-(iv).