AUTH/3476/2/21 - Anonymous, contactable v Leo

Conduct of a representative

Case Summary

A contactable complainant complained about the LinkedIn profile of a named Leo Pharma employee who worked in the medical department.

The complainant alleged that he/she did not believe that the employee in question had ever held the qualification used and thus misrepresented him/herself to the company and health professionals as to his/her professional status.

The complainant noted that on the publicly available LinkedIn profile, with open privacy settings, connected to both health professionals and members of the public, the individual confirmed many activities which he/she had conducted. The complainant alleged breaches of the Code.

In a role as a thrombosis representative at Leo Pharma, the individual’s LinkedIn profile stated ‘Gained a complete switch to Innohep at [named hospital] after numerous failed attempts over 3 years, business worth £150k’. The complainant submitted that switch services facilitated by a pharmaceutical company using a representative were not allowed under the Code and the individual in question had openly admitted that a switch had occurred and that he/she had taken part in it.

The complainant noted that the individual also stated ‘…to extend the use of Innohep in treatment in general surgery - upper/lower GI, urology and hepato-biliary’ and alleged that naming Innohep and a therapy area (thrombosis mentioned in job title) advertised to the public, breaching the Code.

The complainant further alleged that through the individual’s LinkedIn connections to health professionals, he/she had promoted Innohep without prescribing information, a clear link to the location of the prescribing information, the non-proprietary name for Innohep or a date of revision. The complainant alleged breaches of the Code including that the information was disguised promotion.

The complainant alleged that the advertisement had not been certified and that the information about Innohep to the public was not balanced, did not contain any information on adverse events or safety and did not have the adverse event reporting statement required for patients using a medicine.

The complainant further alleged that Innohep was not indicated for ‘extended use in treatment in general surgery - upper/lower GI, urology and hepato-biliary’ according to the Innohep summary of product characteristics (SPC) and therefore the promotion was not in accordance with the SPC.

The complainant noted that the individual stated that he/she had ‘Initiated a project with haematologist and clinics lead for Obs&Gynae … on benefits of Innohep with positive outcome with guideline development’ and alleged that the ‘benefits of Innohep’ in obstetrics and gynaecology was unreferenced, unqualified and a hanging claim and that the individual had promoted Innohep in a manner not in accordance with its SPC.

The LinkedIn profile stated ‘Fully supported the launch of Picato ingenol mebuate for actinic keratosis’ and the complainant alleged that this advertised to the public.

The complainant alleged that through the individual’s LinkedIn connections to health professionals, he/she had promoted Picato to health professionals without prescribing information, a clear link to the location of the prescribing information, a black triangle or a date of revision. The complainant alleged that the advertisement was disguised promotion and that the promotion was not in accordance with the SPC.

The complainant alleged that the advertisement had not been certified and that the information about Picato to the public was not balanced, did not contain any information on adverse events or safety and did not contain the adverse event reporting statement required for patients taking a medicine.

The complainant noted that the LinkedIn profile included ‘Educate and train health professionals in response to unsolicited requests, in the safe and appropriate use of company products particularly in off licence situations where the clinician had already decided to use the product either in a face to face or meeting situation’. The complainant alleged that use of the word ‘safe’ was never appropriate in the discussion of any prescription only medicine and that the individual had a promotional role and had admitted to promoting in off-licence situations and training health professionals in off-licence use.

The complainant stated that many of these points were also repeated under ‘Achievements’ which also stated ‘Supported the launch of its new product for Actin Keratosis’ which the complainant alleged was made to elicit interest in a new product from Leo for actinic keratosis and teased both the public and health professionals on that development.

The complainant noted that ‘new’ could only be used 12 months from launch and Picato was on the market for many years.

The detailed response from Leo is given below.

The Panel noted the complainant’s submission that the employee in question’s LinkedIn account was publicly available, with open privacy settings, and that the employee’s connections included both health professionals and members of the public. The Panel noted that Leo made no submission in that regard and considered, on the balance of probabilities, that both health professionals and members of the public could view the employee’s LinkedIn profile.

The Panel noted Leo’s submission that personal LinkedIn profiles were generally used as a form of online curriculum vitae (CV) for the benefit of recruiters and as such, details of specific successes in current and previous roles would be expected. In the Panel’s view, regardless of how an individual chose to use a social media platform, the content, if within the scope of the Code, had to comply with it; the audience was an important consideration in that regard.

The Panel noted Leo’s submission that the employee had provided evidence of his/her qualification to Leo at the commencement of his/her employment and the authenticity of the certificate had been confirmed. The Panel considered that the complainant had not established that the employee had wrongly referred to a particular qualification and no breach of the Code was ruled.

Innohep

With regard to the allegation about the switch to Innohep, the Panel noted Leo’s submission that the employee in question was approached by a pharmacist at the named hospital who wanted to place Innohep on the hospital formulary and following discussions with relevant health professionals, the formulary positioning was changed by the hospital, effectively ‘switching’ the current anti-thrombotic that was on the formulary to Innohep.

The Panel was concerned about the impression given by the statement with regard to Leo’s role in relation to the switch and queried Leo’s submission that the employee was approached by the hospital given that the employee stated that he/she had managed to gain a complete switch to Innohep ‘after numerous failed attempts over 3 years’. Nonetheless, the Panel considered that the complainant had not discharged his/her burden of proof that Leo had facilitated a switch service as alleged and the Panel, therefore, ruled no breaches of the Code in that regard.

In relation to the allegation that information within the profile advertised Innohep to the public, the Panel noted Leo’s submission that to view this information within a user’s profile, someone would need to look at the user’s work experience, presumably for the purposes of recruitment. In the Panel’s view, LinkedIn was not solely a platform for recruitment; it was a social media platform with a varied audience.

On the evidence before it, the Panel noted that the employee’s profile was publicly available and furthermore the employee’s connections likely included members of the public who were not associated with recruitment. The Panel considered that the information within the employee’s profile, which included reference to Innohep, thrombosis and surgery, was such that Innohep, a prescription only medicine, had been advertised to the public and a breach of the Code was ruled. The Panel considered that high standards had not been maintained in that regard and a breach of the Code was ruled. These rulings were appealed by Leo.

The Panel did not consider that the specific circumstances warranted a breach of Clause 2.

With regard to the allegation that the information about Innohep to the public was not balanced and that it did not contain any information on adverse events or safety, the Panel did not consider that the complainant had established that the lack of safety information about Innohep in the employee’s LinkedIn profile meant that the information about Innohep was misleading with regard to the safety of the product and therefore no breach of the Code was ruled. Further the Panel did not consider that the information was intended for patients taking Innohep and therefore the reporting of side effects statement was not required nor did the information require certification and no breaches of the Code were ruled.

The Panel noted the statements on the employee’s profile in relation to Innohep, including references to thrombosis, surgery and a statement regarding a project that he/she had initiated ‘…on benefits of Innohep…’. In the Panel’s view, such information about prescription only medicines on a user profile, which would likely be read by health professionals that the employee had interacted with in his/her role at Leo, was promotional. In the Panel’s view, Innohep had been promoted to health professionals without the provision of prescribing information, the non-proprietary name or the date which the material was drawn up or last revised and breaches of the Code were ruled. A further breach was ruled as the material had not been certified. These rulings were appealed by Leo.

The Panel noted that the LinkedIn profile in question was clearly labelled as that of a Leo employee and included positive statements about Leo’s medicines. In the Panel’s view, the content within the user’s profile was clearly promotional. The Panel did not consider that the complainant had established that the promotion of Innohep was disguised and no breach of the Code was ruled.

With regard to the employee’s statement, ‘…to extend the use of Innohep in treatment in general surgery …’, the Panel noted Leo’s submission that it would be very difficult to confuse ‘extended use’, which related to duration of treatment with ‘extend the use’, which clearly indicated a desire to increase usage of a medicine in a given therapy area/account; there was no implied claim that Innohep could, or should, be used ‘for extended use in treatment in general surgery’. The Panel did not consider that the complainant had established that the employee’s statement had promoted Innohep in a manner that was inconsistent with its SPC. The Panel therefore ruled no breaches of the Code in that regard.

In relation to the statement, ‘Initiated a project with haematologist and clinics lead for Obs&Gynae at [two named hospitals] on benefits of Innohep with positive outcome with guideline development’, the Panel noted Leo’s submission that the project in question was initiated by the haematologist and the obstetrics and gynaecology clinic lead who had specifically requested more information on Innohep usage in the obstetrics and gynaecology setting. The Panel further noted Leo’s submission that it was appropriate for the employee who was in the medical department at the time to respond to the reactive request and act as a medical information service, however, Leo accepted that the inaccuracy of the LinkedIn profile with regards to that point, and the wording used, was misleading and implied that an activity had taken place that was not in accordance with the Code. The Panel noted Leo’s submission that it would ask the employee to ensure the LinkedIn profile was amended to more accurately reflect what had taken place.

Whilst the Panel was extremely concerned about the inaccuracy of the statement in terms of who had initiated the project, the Panel considered that the complainant had not established that the claim ‘benefits of Innohep’ in the context of the statement in question was unqualified or a hanging comparison; nor had the complainant established that the employee had promoted Innohep in a manner inconsistent with its SPC. The Panel therefore ruled no breaches of the Code in that regard.

Picato

In relation to the allegations about the statements about Picato, the Panel noted Leo’s submission that the EU marketing authorisation for Picato was withdrawn on 11 February 2020 and it was therefore not available for prescription anywhere in the EU.

The Panel had no information before it as to if Picato was a prescription only medicine when the information was first published on the employee’s profile. Picato was not a prescription only medicine at the time of the complaint and therefore on that narrow technical point, the Panel ruled no breaches of the Code in that regard.

The Panel did not consider that the information required certification, nor had an allegation been made about briefing material and it ruled no breaches of the Code. Noting its rulings above, the Panel consequently ruled no breaches of the Code including Clause 2.

Description of employee’s role

The Panel considered that reference to the safe and appropriate use of Leo medicines might be seen as a claim that such medicines were safe. Although there might be a difference between the medicine being safe and the safe use of that medicine, the Code stated that the word ‘safe’ must not be used without qualification and this was not limited to promotional material. The Panel was further concerned that the term ‘safe’ was used in reference to off licence use. The Panel considered that, on balance, the reference to the safe use of Leo’s medicines did not meet the requirements of the Code and a breach was ruled including that high standards had not been maintained. These rulings were appealed by Leo.

The Panel did not consider that the complainant had established that the employee’s statement amounted to an admission to promoting off-licence as alleged. No breaches of the Code were ruled in that regard.

The Panel did not consider that the specific circumstances warranted a breach of Clause 2.

New product

The Panel noted Leo’s submission that in the ‘Achievements’ section of the employee’s profile, the name of the specific medicine was not mentioned and as noted above the marketing authorisation for Picato was withdrawn in February 2020. Furthermore, the Panel considered that the statement was written in the past tense. The Panel considered that the complainant had not established that the use of the word new in this context was in breach of the Code and ruled accordingly.

The Appeal Board noted that LinkedIn was originally primarily used as a resource for recruitment, however, this social media platform had evolved over time, and this might not be how it was currently predominantly used. The Appeal Board noted that the ‘Experience’ section on an individual’s LinkedIn profile was essentially a summary of previous job roles and appeared below the ‘Activity’ section where individuals could be posting, sharing, commenting and liking etc. To fully see the ‘Experience’ section text might require additional clicks and/or scrolling by the reader. The Appeal Board considered that the information within the ‘Experience’ section, which would require an individual to actively search for it, was distinct from user activity on LinkedIn such as posts, comments, ‘likes’ and shares etc which would proactively disseminate information to the user’s LinkedIn connections.

The Appeal Board queried if there was ever a need for a medicine to be named within a LinkedIn profile. Leo submitted that it now trained its staff that medicines should not be mentioned in an online profile and instead suggested the use of therapy area.

On the evidence before it, the Appeal Board noted that although the employee’s profile was publicly available, to reach the ‘Experience’ section at issue would require an interest in the individual’s work experience and several clicks to fully view the information. Such an interest in an individual would likely be by a potential employer or a recruitment company. Based on the nature of the ‘Experience’ section the Appeal Board did not consider that the information within the employee’s profile, which included reference to Innohep, thrombosis and surgery, was such that Innohep, a prescription only medicine, had been advertised to the public and no breach of the Code was ruled. The complainant had not established that high standards had not been maintained in this regard and the Appeal Board therefore ruled no breach of the Code. The appeal on both points was successful.

The Appeal Board did not consider that the information in question within the ‘Experience’ section of the LinkedIn profile constituted promotion to health professionals and it therefore ruled no breaches of the Code including that the material did not need to be certified. The appeal on all points was successful.

With regard to the use of the word safe within the employee’s profile, the Appeal Board considered that there was a difference between the safe use of medicines and describing a medicine as safe, and in this case the reference to the safe and appropriate use of Leo medicines did not describe a particular medicine as safe. The reference would likely be read as relating to training and medicines in general rather than a specific medicine and no breaches of the Code were ruled including that the complainant had not established that high standards had not been maintained in this regard. The appeal on both points was successful.