Case Summary
This case was in relation to the landing page that appeared when the Ajovy (fremanezumab) website was accessed.
The Panel ruled no breach of the following Clause(s) of the 2021 Code on the basis that it did not consider that the complainant had discharged his/her burden of proof that reference to Ajovy on the landing page, in the particular circumstances of this case, meant that it promoted Ajovy to health professionals or that the landing page was aimed specifically at patients taking Ajovy:
No Breach of Clause 12.3
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Requirement to include the non-proprietary name in promotional material
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No Breach of Clause 12.10
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Requirement to include the black triangle in promotional material
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No Breach of Clause 26.4
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Requirement to include the black triangle in material which relates to a medicine that is intended for patients taking that medicine
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This summary is not intended to be read in isolation.
For full details, please see the full case report
CASE AUTH/3602/1/22 NO BREACH OF THE CODE
COMPLAINANT v TEVA
Concerns regarding Ajovy website www.ajovy.co.uk
CASE SUMMARY
This case was in relation to the landing page that appeared when the Ajovy (fremanezumab) website was accessed.
The Panel ruled no breach of the following Clause(s) of the 2021 Code on the basis that it did not consider that the complainant had discharged his/her burden of proof that reference to Ajovy on the landing page, in the particular circumstances of this case, meant that it promoted Ajovy to health professionals or that the landing page was aimed specifically at patients taking Ajovy:
No Breach of Clause 12.3
|
Requirement to include the non-proprietary name in promotional material
|
No Breach of Clause 12.10
|
Requirement to include the black triangle in promotional material
|
No Breach of Clause 26.4
|
Requirement to include the black triangle in material which relates to a medicine that is intended for patients taking that medicine
|
This summary is not intended to be read in isolation.
For full details, please see the full case report below.
FULL CASE REPORT
A contactable complainant who described him/herself as a concerned UK health professional complained about the Ajovy (fremanezumab) website (https://www.ajovy.co.uk).
Teva UK Limited marketed Ajovy which was indicated for the prophylaxis of migraine in adults who had at least 4 migraine days per month.
COMPLAINT
The complainant provided a screenshot which stated ‘Are you a healthcare professional? To access this section of the AJOVY website you need to be a member of the healthcare profession because the materials included in this area of our website are specifically prepared for that audience only’. It then asked readers to ‘Please click on the appropriate button below to confirm that you are a healthcare professional’ and gave two options to select from ‘I am a healthcare professional’ and ‘I am not a healthcare professional’. The complainant stated that the generic name and black triangle were both missing.
When writing to Teva, the Authority asked it to consider the requirements of Clauses 12.3, 12.10 and 26.4 of the 2021 Code.
RESPONSE
Teva stated that it took compliance with the Code extremely seriously and had fully investigated this matter.
Teva submitted that the pop-up that was the subject of the complaint was the first item that appeared when the www.ajovy.co.uk website was accessed either directly or indirectly, for example, via a Google search by someone who was aware of the website, and therefore, the product name. The www.ajovy.co.uk URL was signposted on promotional items such as leavepieces and other health professional-facing material used by the field force in virtual and physical calls/meetings and could be entered in a browser as above or found via search engines. This pop-up was an entry page to the promotional (or non-promotional) webpages and, as such, was not part of any promotional or non-promotional information; rather, it was there to ensure appropriate access to the relevant information as required under the Code.
Teva submitted that on selecting the appropriate status, as ‘I AM NOT A HEALTHCARE PROFESSIONAL’, there was a further pop-up requesting confirmation of status. The ‘I am a patient or member of the public’ or ‘a UK health professional’ needed to be selected to access the appropriate sections of the corporate website and relevant product information, ensuring access to appropriate content only as per that website. When selecting the ‘I AM A PATIENT OR MEMBER OF THE PUBLIC’ here, the click linked directly to the Ajovy listing area detailing the generic name, black triangle, Adverse Event statement with appropriate additional wording referring to the black triangle.
Teva stated that when selecting ‘I AM A HEALTHCARE PROFESSIONAL’ from the pop-up which was the subject of this complaint the click again went directly to an Ajovy page with generic name, black triangle and Adverse Event statement.
Teva stated that it therefore refuted all allegations of breaches of Clauses 12.3, 12.10 and 26.4 of the 2021 Code as highlighted above.
Teva stated that it refuted the pop-up was a breach of the Code, however, the company had made changes to the pop-up and removed the product name to ensure that such a similar complaint could not be brought in the future. Furthermore, Teva wished to formally state that, in its opinion, the case preparation manager should declare that there was no prima facie case in this matter as per Section 5.5 of the complaints procedure in the 2021 Code.
Teva provided the certificate and the qualifications of the Medical Signatory who was no longer employed by Teva UK Ltd.
PANEL RULING
The Panel noted Teva’s submission that the pop-up at issue was the first item that appeared when the www.ajovy.co.uk website was accessed either directly or indirectly, for example, via a Google search by someone who was aware of the website, and therefore, the product name. The Panel noted Teva’s submission that the www.ajovy.co.uk URL was signposted on promotional items such as leavepieces and other health professional-facing material used by the field force in virtual and physical calls/meetings and could be entered in a browser or found via search engines. The Panel noted that the landing page appeared to be a mechanism to direct potential audiences (health professionals and the public) to information relevant to each.
Whilst the Panel noted that the landing page included reference to the brand name Ajovy, there were no claims made for it nor were the indications listed. Whilst the Panel considered that it might have been prudent to include the non-proprietary name and black triangle, it did not consider that the complainant had discharged his/her burden of proof that reference to Ajovy on the landing page, in the particular circumstances of this case, meant that it promoted Ajovy to health professionals and thus required the inclusion of the non-proprietary name and black triangle as set out in Clauses 12.3 and 12.10 and no breach of each of these clauses was ruled. The Panel noted that Teva had, nonetheless, removed the product name from the landing page at issue to ensure that such a similar complaint could not be brought in the future.
Nor did the Panel consider that the landing page was aimed specifically at patients taking Ajovy and thus the requirement to include a black triangle, together with a statement describing what it meant as set out in Clause 26.4, was not relevant and no breach was ruled in this regard.
Complaint received 20 January 2022
Case completed 14 March 2023