AUTH/3428/11/20 - Anonymous, contactable complainant v Leo

Use of LinkedIn

Case Summary

An anonymous, contactable complainant alleged that Leo Pharma’s use of LinkedIn did not comply with the Code.

The complainant submitted that the Leo UK corporate website suggested a link to the Leo LinkedIn page, however, the reader was directed to ‘Leo Pharmaceuticals Ballerup DK’, which appeared to be the global LinkedIn page for Leo Pharma. That page contained a variety of postings but it was clear that Leo UK used that global page.

The complainant alleged that some posts and materials were not suitable for a UK audience and some did not contain all the requirements of the Code. As a result, it appeared that Leo UK was directing an intended UK audience to a site containing uncertified material. Leo UK employees had interacted with those posts through reactions to the posts on LinkedIn such as ‘likes’.

The complainant queried whether Leo UK could confirm that all posts on Leo Pharmaceuticals Ballerup DK page had been certified under the UK Code.

The complainant stated that there was no accounting how many times a recipient might have received notice of an inappropriate post if multiple Leo employees had interacted with such a post and a health professional was connected with more than one Leo employee.

The complainant stated that based on their LinkedIn job titles, it would appear that Leo UK employees had engaged with posts through LinkedIn reactions (‘likes’, support or celebrate engagement). The complainant made multiple allegations about a number of posts, including that in some instances promotion had been disguised and that Leo had not trained its staff on the use of social media.

Post A

The post, which was accompanied by a video of Leo employees, read:

‘29th October is #worldpsoriasisday. At Leo Pharma, we're marking this day by launching a series of patient videos that outline everyday challenges of living with psoriasis. Learn more about our commitment to helping people with psoriasis, not just today - but every day - by visiting www.everydaypsoriasis.com #beinformed #WPD2020 #everydaypsoriasis.’

The complainant stated that on clicking the URL link, readers would believe they were being directed to a psoriasis website, when in fact the link brought them to www.leo-Pharma.com and to a page which gave information on psoriasis. The complainant alleged that this was very misleading and on initial presentation disguised the possible source of information as another URL.
Post B

The complainant stated that the post, which was accompanied by a video with a UK patient read:

‘Jane’s Story.... “What makes me feel bad is when I see other people looking... Because you can see the cogs working like, oh, is she contagious?”

Psoriasis doesn’t care what day it is. That’s why we at Leo Pharma have chosen to mark #worldpsoriasisday this year with a series of patient stories about everyday challenges of living with psoriasis. Learn more about how we’re committed to helping people with psoriasis not just today but every day by visiting www.everydaypsoriasis.com #beinformed #WPD2020 #everydaypsoriasis.’

The complainant noted that the post had been ‘liked’ and ‘supported’ by three named Leo UK employees and queried whether the post and video had been certified.

Readers would be led to believe they were being directed to a psoriasis website, when in fact the link brought them to www.leo-Pharma.com and to a page which gave information on psoriasis. The complainant alleged that this was very misleading and on initial presentation disguised the possible source of information as another URL.


Post C

The post, which was accompanied by a video called ‘EADV Teaser’ featuring a UK health professional, read:

‘Are you a healthcare professional planning to attend #EADVirtual next week?

Then we’ve got a treat for you - our sponsored Satellite Symposium will take the “virtual” theme to another level. Watch [named health professionals from Germany, UK and Canada] as they use the power of digital visualisation to explore our theme “Long-term topical management of psoriasis: the road ahead” (SAT 3.3 virtual room Alibert).’

The complainant alleged that the post acted as an invitation to a promotional event and was therefore promotional in itself. The complainant queried whether Leo UK had certified the presentations, videos, or content for the EADV symposium.

The complainant alleged that two named Leo UK employees had interacted with the post through ‘likes’ and ‘applause’ and promoted a prescription only medicine to the public. The complainant noted that the invitation did not contain prescribing information or any mandatory information which an advertisement should carry. The video aspect of the post featured some very fast-moving preview shots of what the viewer could expect at the symposium and was called an ‘EADV Teaser’ by Leo which the complainant alleged breached the Code.

The results of the study for Enstilar were included with the wording ‘No skin atrophy’ on one slide. The complainant alleged that the video advertised a prescription only medicine to the public, did not contain prescribing information nor date of revision.

The complainant pointed out that Section 4.8 of the Enstilar summary of product characteristics (SPC) stated ‘Local reactions can occur after topical use, especially during prolonged skin application, including skin atrophy....’. To state ‘no skin atrophy’ was misleading, not balanced, compromised safety and promoted a medicine outside of its authorisation.

The complainant alleged that the use of LinkedIn represented disguised promotion and by interacting with the post, Leo UK had invited a UK audience to the symposium at which one of the presentations was by a UK health professional; the content of the symposium should have been certified.


Post D

The post read:

‘We are proud to welcome our new oral IL-17A protein-protein interaction modulator to our clinical pipeline.

Did you know that it’s very challenging to obtain an oral small molecule drug with the efficacy of an antibody?

Through clever design, our R&D team has come up with a drug candidate which has been selected to enter development. Why is this news so ground-breaking? We’ll let our [named senior executive] explain the science behind. #PioneeringTogether.’

The post was accompanied by a video in which a senior Leo employee made product claims.

The complainant noted that a senior Leo employee and four other named employees had ‘liked’ the post and by engaging with the post on PPI-IL-17, the Leo UK employees had shared content in which an unauthorised medicine had been positioned in a positive way, and was advertising to the public and a health professional audience before granting of the authorisation. The posting and video did not contain a black triangle or prescribing information. The information provided to the public on the PPI-IL-17 also raised a lot of hope, potentially unfounded given the stage of development.


Post E

The post read:

‘Eczema is not only a skin condition. Atopic dermatitis is a type of eczema that can have a significant, negative impact on quality of life, primarily due to distressing itch, sleep disturbance and social embarrassment due to visible lesions. On World Atopic Eczema Day, we are proud to support eczema warriors.

Learn more about how we are working to make a difference in the lives of people living with skin diseases at www.leo-Pharma.com
#DermatologyBeyondTheSkin #LeoPharmaCares #AtopicEczemaDay.’

Leo UK employees had ‘liked’ this post and the complainant queried whether the post and video had been certified.


Post F

The post read:

‘Thank you to writer and eczema warrior [name] for sharing your story with Leo Pharma on #AtopicEczemaDay to help us address the greatest needs of people living with eczema. We are inspired by your journey and passion for raising the voices of eczema warriors.

Learn more about how we are working together to make a difference in the lives of people living with skin conditions at www.leoPharma.com #DermatologyBeyondTheSkin #LeoPharmaCares’.

This was accompanied by a picture asking the reader to ‘Add your voice to World Atopic Eczema Day.’

The complainant noted that two named Leo UK employees had ‘liked’ this post and queried if it had been certified.


Post G

The post read:

‘We’re proud to stand with people living with eczema on #AtopicEczemaDay and every day. LEARN MORE about how we are working to make a difference in the lives of people living with skin diseases at www.leo-Pharma.com #DermatologyBeyondTheSkin #LeoPharmaCares.’

The text was accompanied by a picture giving the date of Atopic Eczema Day and:

‘How do YOU care for atopic eczema?.’

The complainant noted that eight named Leo UK employees had ‘liked’ the post and queried if it had been certified and whether the information accessed via the link had been assessed under the Code.


Post H

The post read:

‘August is Psoriasis Action Month. Psoriasis is a skin condition that impacts more than 8 million people in the United States and 125 million people worldwide. Raising awareness can be a first step toward changing the perception of psoriasis. Show your support by learning more about the disease and get involved. #PsoriasisActionMonth #ThisIsPsoriasis #PioneeringDermatology #DermatologyBeyondTheSkin.’

The complainant noted that two named Leo UK employees had ‘liked’ the post and queried whether the post had been certified or if the information accessed via the link had been assessed under the Code.


Post I

The post read:

‘We are proud to share this great news regarding Gorlin Syndrome Alliance. On November 9, 2020, our patient organisation partner will conduct a Listening Session with FDA. This ninety-minute virtual meeting is a fantastic opportunity to raise awareness on [sic] Gorlin Syndrome and give a voice to people living with this condition. To learn more about the session please refer to the post below #DermatologyBeyondTheSkin #PioneeringTogether.’

The complainant noted that a named senior Leo UK employee had ‘liked’ this post and queried whether it had been certified.


Post J

The post read:

‘Did you know atopic dermatitis (AD) - also known as atopic eczema - is the most common inflammatory skin disease in the developed world? Learn more at [a link was provided to a website called eczema.com which appeared to be a Leo website].’

A picture accompanied the post with a message:

‘Atopic dermatitis affects up to 5% of adults across the United States, Canada, Europe and Japan.’

The complainant noted that two named Leo UK employees had ‘liked’ the post and queried whether it had been certified and whether the material accessed via the link been assessed under the Code.


Post K

The post stated:

‘#PRESS: Today, we announce results from the Phase 3 PSO-LONG study of potential long-term, proactive psoriasis management as ePosters by American Academy of Dermatology. Leo Pharma is committed to building on our 30+ year heritage of pursuing innovative products for patients affected by psoriasis, as well as other chronic skin conditions. You can read more about the results here.’

The post was accompanied by a picture and the following statement attributed to a senior executive:

‘Our vision in psoriasis is to provide prescription solutions for patients with all severities of psoriasis. Our diverse pipeline of innovative late stage drug candidates aims to support a range of treatment options for people living with psoriasis and other chronic skin conditions across the globe.’

The complainant noted that two named Leo UK employees had ‘liked’ the post and queried whether the post text and picture had been certified.

The complainant alleged that the post promoted a link to material which discussed the long-term use study results for Enstilar, therefore advertising a prescription only medicine to the UK public. Neither the post nor the item on the link had prescribing information.


Post L

The post read:

‘#PRESS: Today we featured new Phase 3 data for adults with moderate-to-severe atopic dermatitis (AD) at the American Academy of Dermatology virtual meeting experience. We focus on advancing treatments that have the potential to address areas of high unmet need for the millions of people who experience some form of eczema, including AD.

Leo Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. For more: [link provided].’

The post was accompanied by a picture with the following statement:

‘Leo Pharma’s heritage in medical dermatology and strategic focus on advancing the science of skin inflammation diseases uniquely positions us to address the significant and varied unmet needs of people living with atopic dermatitis.’

The complainant noted that a named Leo UK employee had ‘liked’ the post which promoted a link to material which discussed the Phase 3 results of a yet to be authorised prescription medicine, tralokinumab, therefore advertising a prescription only medicine to the UK public and promoting a product before authorisation to a health professional. Neither the post nor the item on the link had prescribing information. The complainant queried whether the post text and picture had been certified.


Post M

The post read:

‘Psoriasis is a chronic, systemic #inflammatorydisease that primarily affects the skin. Psoriasis does not just cause physical discomfort; the true burden of psoriasis is much bigger. Learn more at:’ – a web address was listed.

A picture accompanied the post with a statement that:

‘125 million people worldwide live with psoriasis.’

The complainant noted that seven named Leo UK employees had ‘liked’ the post and queried whether the post and picture had been certified and whether the material accessed via the link had been assessed under the Code.


Post N

The post read:

‘#PRESS: Today we announced top line results from the Phase 3 randomised, double blind, placebo controlled multinational 52 week ECZTRA 1-3 clinical studies evaluating an investigational treatment in adults with moderate-to-severe atopic dermatitis (AD). AD is the most common inflammatory skin disease in the developed world that affects up to 5 percent of adults across the United States, Canada, Europe and Japan. AD can have a significant, negative impact on patients well being, primarily due to distressing itch, sleep deprivation and social stigmatisation due to visible lesions.’

The complainant noted that three named Leo UK employees had ‘liked’ the post which promoted a link to material which discussed the Phase 3 results of a yet to be authorised prescription medicine, tralokinumab, therefore advertising a prescription only medicine to the UK public and promoting a product before authorisation to a health professional. Neither the post nor the item on the link had prescribing information. The complainant queried whether the post text and link had been certified.

The detailed response from Leo is given below.


The Panel noted Leo’s submission that the LinkedIn page at issue was the corporate page for Leo Pharma globally; it was owned by Leo Pharma Ballerup Denmark which Leo submitted was stated at the top of the page and managed by the global corporate communications team in Denmark. The Panel did not have a copy of this LinkedIn page before it. The Panel further noted Leo’s submission that the content posted was directed globally, with contributions from Leo affiliates around the world; Leo’s global team posted content for all users, whereas Leo affiliates only posted content directed towards their local audiences.

The Panel considered that information or promotional material about medicines placed on the Leo Pharma global LinkedIn page outside of the UK would be within the scope of the Code if it was placed there by Leo UK/with Leo UK’s authority, or if it was placed there by an affiliate to Leo UK (or with its authority) and specifically referred to the availability or the use of a Leo medicine in the UK. Further, material directed at a UK audience would be within the scope of the Code.

The Panel considered that as a UK audience was directed to the global LinkedIn page it would fall within the scope of the Code. If this were not the case, then companies could refer to global LinkedIn pages as a means of circumventing the Code.

In addition, the Panel considered that the UK employees’ engagement with the fourteen posts, on the balance of probabilities, had proactively disseminated the material to their connections on LinkedIn, and therefore also brought each post and its associated content within the scope of the Code. Any material associated with a social media post, for example a video or link within a post, would be regarded as being part of that post and the Panel made its rulings in that regard.

Post A

The Panel noted Leo’s submission that the link within the post to www.everydaypsoriasis.com took users to information relating to psoriasis on the Leo Pharma A/S website, including stories of patient experiences. The Panel noted that the webpage referred to ‘… lots of different types of treatment that help people to manage [psoriasis] and improve quality of life’ and referred to managing the condition via treatments and lifestyle changes. In the Panel’s view, neither the webpage nor the video made a direct or indirect reference to a specific treatment and it appeared to be disease awareness information for the public.

Four of the individuals named by the complainant as having engaged with Post A were employed by Leo UK. The Panel considered that the UK employees’ engagement with the post, on the balance of probabilities, had proactively disseminated the material to their connections on LinkedIn, not all of whom would meet the Code’s definition of a health professional.

The Panel ruled no breach of the Code in relation to the requirement to certify promotional material as it was educational material for the public related to psoriasis. However the material had not been certified as required by the Code and a breach was ruled as acknowledged by Leo. This ruling was unsuccessfully appealed by Leo.

The Panel considered that it was sufficiently clear from the post that the reader was being directed to a Leo owned website; the post referred to learning more about our (Leo’s) commitment ‘…by visiting www.everydaypsoriasis.com’. The Panel therefore ruled no breach of the Code in that regard.

Post B

The Panel noted its comments above about Post A in relation to the content of the website www.everydaypsoriasis.com.

The Panel noted that the video that was part of the LinkedIn post made no direct or indirect reference to a medicine; the video discussed a patient’s experience of living with psoriasis.

Two of the individuals named by the complainant as having engaged with Post B were employed by Leo UK. The Panel considered that the UK employees’ engagement with the post, on the balance of probabilities, had proactively disseminated the material to their connections on LinkedIn not all of whom would meet the Code’s definition of a health professional.

The Panel ruled no breach of the Code in relation to the requirement to certify promotional material as it was educational material for the public related to psoriasis. However as the material had not been certified as required by the Code a breach was ruled as acknowledged by Leo.

The Panel considered that it was sufficiently clear from the post that the reader was being directed to a Leo owned website and therefore ruled no breach of the Code in that regard.

Post C

The Panel noted Leo’s submission that the link to more information within the post directed readers to a Leo congress website where users had to declare that they were a health professional. Users could then access details of a symposium entitled ‘Long-term topical management of psoriasis: the road ahead’ which also included a link to register for the webinar and the date, time and agenda. The agenda did not name a specific medicine but stated that data from recently published new studies would be presented.

The LinkedIn post was accompanied by a video called ‘EADV Teaser’ which was a number of fast-moving images set to a background of music which appeared to show, amongst other things, slides with data from the PSO-LONG clinical trial. The claim ‘No cases of skin atrophy’ was stated boldly in the centre of one slide. The video did not directly name a medicine, however, the Panel noted Leo’s submission that the PSO-LONG trial investigated Leo’s prescription only medicine Enstilar (betamethasone dipropionate/calcipotriol monohydrate), which was a topical treatment for psoriasis vulgaris in adults.

Two of the individuals named by the complainant as having engaged with Post C were employed by Leo UK. The Panel further noted Leo’s submission that one of those employees had no health professional LinkedIn contacts and the other who did have such contacts was limited to those health professionals who had expressed an interest in working in the pharmaceutical industry, including at Leo.

The Panel considered that the UK employees’ engagement with the post, on the balance of probabilities, had proactively disseminated the material to their connections on LinkedIn. The Panel noted that not all the employees’ connections on LinkedIn would meet the Code’s definition of a health professional. However, the Panel considered that members of the public were unlikely to make any connection between PSO-LONG and Enstilar. The Panel therefore considered, on the balance of probabilities, that a prescription only medicine had not been promoted to the public and no breach of the Code was ruled.

The Panel noted Leo’s submission that one of the UK employees who engaged with Post C had connections who were health professionals. The Panel considered that some health professionals would link the information about PSO-LONG in the post to Enstilar. In the Panel’s view, the video, which formed part of the post and which prominently displayed the name of the Enstilar clinical trial (PSO-LONG) and included claims such as ‘No cases of skin atrophy’ was promotional material for Enstilar. The LinkedIn post, which included the video, was promotional material which had not been certified and the Panel ruled a breach of the Code. This ruling was unsuccessfully appealed by Leo. The Panel ruled no breach in relation to the allegation that educational material had not been certified.

As prescribing information had not been provided the Panel ruled a breach of the Code which was unsuccessfully appealed by Leo.

As there was no display of the brand name within the post or associated video or link to further information there was no requirement to state the non-proprietary name and so the Panel ruled no breach of the Code.

The image of the LinkedIn post did not give the exact date it was posted. There was no date on when the promotional material was drawn up or last revised and therefore the Panel ruled a breach of the Code. This ruling was unsuccessfully appealed by Leo.

The Panel noted Leo’s submission that Enstilar did not need to include an inverted black triangle; the Panel ruled no breach of the Code in that regard.

The Panel noted that section 4.8 of the Enstilar SPC stated:

‘Betamethasone (as dipropionate):

Local reactions can occur after topical use, especially during prolonged application, including skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation, and colloid milia.’

The Panel considered that the prominent claim within the video of ‘No cases of skin atrophy’, within the context of the fast-moving images in this short video, was misleading with respect to the safety of Enstilar and was inconsistent with the particulars listed in its SPC; breaches of the Code were ruled. These rulings were unsuccessfully appealed by Leo.

The Panel considered that as it was unlikely that the public would make a connection between PSO-LONG and Enstilar; in that regard, the post did not provide misleading information to the public about the side effects of Enstilar and no breach of the Code was ruled.

The Panel considered that the LinkedIn post and its associated video and link promoted a webinar and provided a trailer to elicit people’s interest in the event and although it was unfortunate that it was referred to as a ‘teaser’, it was not teaser advertising as referred to in the Code. The Panel ruled no breach in that regard.

The Panel noted Leo’s submission that the symposium was sponsored by Leo Pharma A/S and held virtually at the European Academy of Dermatology and Venereology Congress in November 2020. The Panel further noted that Leo accepted that the dissemination of invitations for the symposium to UK health professionals would mean that the content of the symposium would require certification in accordance with the Code and that this had not occurred.

The Panel considered that the employee’s engagement with the post, on the balance of probabilities, had proactively disseminated the material to his/her connections on LinkedIn, most of whom would be UK based, and therefore he/she had invited UK health professionals to the symposium and therefore the symposium content required certification. The Panel therefore ruled a breach of the Code.

Post D

The Panel noted that the post included a video where a senior Leo employee referred to an investigational molecule as having a ‘Completely unique mode of action’ and that it was a ‘true unique opportunity’.

Five Leo UK employees identified by the complainant had ‘liked’ the post at issue. The Panel considered that the UK employees’ engagement with the post, on the balance of probabilities, had proactively disseminated the material to their connections on LinkedIn not all of whom would meet the Code’s definition of a health professional.

It was not necessarily unacceptable for a company to refer in general terms to its pipeline products on its corporate accounts. However, language, context, location, layout, intended audience and overall impression were important factors. The Panel queried whether a social media platform such as LinkedIn with a varied audience was the appropriate forum to share such information.

The Panel noted Leo’s submission that the oral compound discussed in Post D was in early development and clinical trials had not yet commenced. It was clear that Leo was a long way off having the compound available for use when the post was made or engaged with by UK employees. The Panel noted its comments above and did not consider that the post promoted a medicine prior to the grant of its marketing authorisation and no breach of the Code was ruled. The Panel consequently ruled no breaches of the Code in relation to the requirements for promotional material. The Panel did not consider that the post required certification and ruled no breaches of the Code in that regard.

The compound referred to was not a prescription only medicine when the LinkedIn post was made or ‘liked’ by the five Leo UK employees. The Panel therefore ruled no breach of the Code with regard to the allegation that the LinkedIn post raised the hopes of the public.

Posts E-J, M

The Panel noted that in relation to Posts E, F, G, H, I, J and M, the complainant had questioned if the posts had been certified.

The Panel noted Leo’s submission that a number of Leo UK employees had ‘liked’ each post which ranged from 1 employee (Post I) to 8 employees (Post G).

The Panel considered that the UK employees’ engagement with each post, on the balance of probabilities, had proactively disseminated the material to their connections on LinkedIn.

In the Panel’s view, there was no direct or indirect reference to a specific prescription only medicine in Posts E, H, I, J and M. The webpage accessed from the link within each of posts E, H, J and M, from the evidence provided by Leo, made no direct or indirect reference to a specific prescription only medicine nor did the post from the Gorlin Syndrome Alliance included within Post I. On the evidence before it, the Panel considered that the complainant had not discharged his/her burden of proof that Posts E, H, I, J and M were promotional material and no breach of the Code in relation to the certification of promotional material was ruled in relation to each.

In the Panel’s view, Posts E, H, J and M contained disease information about either eczema or psoriasis and were thus educational material for the public related to disease which required certification under the Code. The Panel disagreed with Leo’s submission that the content of Post H was too limited to bring the text within the scope of the certification requirements for material for the public; the post described psoriasis as a skin condition that impacted more that 125 million people worldwide and linked to the US National Psoriasis Foundation website. A breach of the Code was ruled in relation to each of Posts E, J and M, as acknowledged by Leo, and also in relation to Post H. The ruling in relation to post H was unsuccessfully appealed by Leo.

Post I referred to a future virtual meeting between the Food and Drug Administration (FDA) and the Gorlin Syndrome Alliance which was a US patient organisation that Leo referred to as a ‘partner’; the forthcoming meeting was to raise awareness of the condition. There was no disease information within the post and the Panel had no information before it as to the content of any links within the post. It was not clear if Leo UK had any relationship with the Gorlin Syndrome Alliance. On the evidence before it the Panel considered that the complainant had not discharged his/her burden of proof that the post required certification under the Code and the Panel ruled no breach of the Code in relation to Post I.

Posts F and G highlighted World Atopic Eczema Day but had no educational information about the disease or any direct or indirect reference to a specific prescription only medicine within the body of each post. The link within Post F led directly to the media page on the Leo Pharma A/S website which included a list of recent press releases below a bold prominent statement ‘Our press releases are intended for the media’. Post G also appeared to link to the same webpage on the Leo Pharma A/S website but Leo had made no submission in that regard.

The Panel noted Leo’s submission that the list of press releases on the media page would change over time and that it was standard practice for Leo Pharma A/S to delete certain press releases after a period of 3 weeks. The Panel had no information before it as to what press releases were available on the webpage in question when the post was made or UK employees engaged with it. The Panel noted that the content of Posts F and G were in relation to World Atopic Eczema Day and not in relation to a Leo clinical trial. As noted above neither post contained any educational information about eczema. The Panel considered that the complainant had not established, on the balance of probabilities, that Posts F and G were promotional material or otherwise required certification under the Code and no breaches were ruled in relation to each post.

Post K

The Panel noted that the link within the post referred to by the complainant led to the media page of the Leo Pharma A/S website; it appeared to the Panel that the reader was being directed to read more about the results from PSO-LONG via a press release within the media section of the global Leo corporate website. The Panel did not have a copy of the press release; Leo made no submission in that regard although the complainant had stated that the post promoted a link to material which discussed study results of the long-term use of Enstilar.

The Panel considered that there was a difference between making a press release available only to the press, to be published or not, and proactively disseminating it on a publicly accessible social media platform with the inevitability that a wider audience would read it. The use of #PRESS at the beginning of the post would not be likely to restrict the audience to the relevant media.

In the Panel’s view, the post, which referred to psoriasis and an Enstilar clinical trial by name (PSO-LONG) and directed users to a webpage to read results from the trial was promotional material for Enstilar.

The Panel had no information before it as to what press releases where available from the webpage in question when the post was made or when UK employees engaged with it but considered that, on the balance of probabilities, given that the post began with ‘#PRESS: Today, we announce results from the Phase 3 PSO-LONG study…’ and ended with ‘You can read more about the results here: [link]’ that readers were being directed to view study results from PSO-LONG.

Two Leo UK employees identified by the complainant had ‘liked’ the post at issue. The Panel considered that the UK employees’ engagement with the post, on the balance of probabilities, had proactively disseminated the material to their connections on LinkedIn not all of whom would meet the Code’s definition of a health professional. Enstilar was classified as a prescription only medicine when the post in question was made and the UK employees ‘liked’ it. Although the Panel considered that it was unlikely that members of the public would link ‘PSO-LONG’ to Enstilar, the post referred to psoriasis and innovative products for the condition and as such would encourage readers to ‘read more about the results’ as invited; the link in the post would, on the balance of probabilities, have directed users to a webpage where they could view more information which would refer to the efficacy results of Leo’s medicine. Therefore the post promoted a prescription only medicine to the public and a breach of the Code was ruled.

The Panel considered that as Leo employees who had ‘liked’ the post would, on the balance of probabilities, have had connections who met the Code’s definition of a health professional, the post also promoted Enstilar to health professionals. The promotional material had not been certified nor did it include prescribing information and the Panel ruled breaches of the Code. No breach of the Code was ruled in relation to the requirement to certify material for the public as the material was promotional.

Post L

The Panel noted that the link within the post referred to by the complainant led to the media page of the Leo Pharma A/S website; it appeared to the Panel that the reader was being directed to read more about the results from a Phase 3 trial for adults with moderate-to-severe atopic dermatitis via a press release within the media section of the global Leo corporate website. The Panel did not have a copy of the press release; Leo made no submission in that regard although the complainant submitted that the post promoted a link to material which discussed the Phase 3 results of a yet to be authorised prescription medicine, tralokinumab.

The Panel disagreed with Leo’s submission that the ‘For more’ link within the post related to the annual report rather than to any particular Phase 3 data and that there was no reference to any specific data. From the webpage provided by Leo, it was clear that it housed press releases in addition to the annual report. The Panel had no information before it as to what press releases where available from the webpage in question when the post was made or when UK employees engaged with it but considered, on the balance of probabilities, that readers were being directed to view study results.

The Panel considered that there was a difference between making a press release available only to the press, to be published or not, and proactively disseminating it on a publicly accessible social media platform with the inevitability that a wider audience would read it. The use of #PRESS at the beginning of the post would not, in the Panel’s view, restrict the audience to the relevant media. In the Panel’s view, the post, which referred to a Leo Phase 3 clinical trial in atopic dermatitis and directed users to a webpage where they could read results from the trial was promotional material for the medicine.

One Leo UK employee identified by the complainant had ‘liked’ the post at issue. The Panel considered that the UK employee’s engagement with the post, on the balance of probabilities, had proactively disseminated the material to his/her connections on LinkedIn not all of whom would meet the Code’s definition of a health professional.

The Panel noted the complainant’s allegation that the data which was being referred to was Phase 3 data on a yet to be authorised product, tralokinumab, which was not a prescription only medicine when the post in question was ‘liked’ by the UK employee and on that narrow technical point the Panel ruled no breach of the Code. A further ruling of no breach was made in relation to the absence of prescribing information.

The Panel noted Leo’s submission that in advance of the American Academy of Dermatology Virtual Meeting Experience (AADVMX) Leo UK employees were advised not to engage with social media posts from Leo global or US apart from one described UK/IE post (which was not Post L); specific reference was made to LinkedIn channels in this regard.

The Panel considered, on the evidence before it, that the proactive dissemination of a LinkedIn post which, on the balance of probabilities, directed readers to find information on Phase 3 tralokinumab study results meant that tralokinumab had been promoted prior to the grant of its marketing authorisation. A breach of the Code was ruled.

As the promotional material had not been certified the Panel ruled a breach of the Code. This ruling was unsuccessfully appealed by Leo. No breach of the Code was ruled with regard to the requirement to certify material for the public.

Post N

The Panel noted that it appeared that the link within the post would direct users to the media page of the Leo Pharma A/S website as in Post L above. It appeared to the Panel, that the reader was being directed to read more about the results from the ECZTRA trial . The Panel did not have a copy of the press release; Leo made no submission in that regard although the complainant submitted that the post promoted a link to material which discussed the Phase 3 results of a yet to be authorised medicine, tralokinumab.

The Panel had no information before it as to what press releases where available from the webpage in question when the post was made or when UK employees engaged with it but considered that readers were being directed to view study results.

The Panel considered that there was a difference between making a press release available only to the press, to be published or not, and proactively disseminating it on a publicly accessible social media platform with the inevitability that a wider audience would read it. The use of #PRESS at the beginning of the post would not, in the Panel’s view, restrict the audience to the relevant media.

In the Panel’s view, the post, which referred to a Leo Phase 3 clinical trial in atopic dermatitis and directed users to a webpage where they could read results from the trial was promotional material for the medicine.

The UK employees’ engagement with the post, on the balance of probabilities, had proactively disseminated the material to their connections on LinkedIn not all of whom would meet the Code’s definition of a health professional.

The Panel noted that tralokinumab was not a prescription only medicine when the complaint was submitted. On that narrow technical point the Panel ruled no breach of the Code in relation to alleged promotion to the public.

The Panel considered, on the evidence before it, that the proactive dissemination of a LinkedIn post which, on the balance of probabilities, directed readers to Phase 3 study results on tralokinumab meant that tralokinumab had been promoted prior to the grant of its marketing authorisation. A breach of the Code was ruled.

The promotional material had not been certified and the Panel ruled a breach of the Code. This ruling was unsuccessfully appealed by Leo. No breach of the Code was ruled with regard to the requirement to certify material for the public.

Overall

The Panel noted its comments and rulings of breaches of the Code above and ruled a breach as Leo had failed to maintain high standards.

The Panel noted Leo’s submission in relation to the training materials available contemporaneous to the complaint. The Panel noted that the Leo employees’ personal use of social media policy was dated 2013 and contained statements which were ambiguous and did not reflect case precedence. For example:

‘Personal posts relating to LEO products are strongly discouraged, and it is strictly forbidden for you to make any statement that implies any product benefit, efficacy, clinical trial, safety claim or any other content that may be regarded as promotional.’

The term ‘strongly discouraged’ did not, in the Panel’s view, give employees an unequivocal instruction.

Furthermore, under the heading, ‘reference to any topic related to our business’ it stated:

‘Be clear to separate your opinions from those of LEO, by including remarks such as “the views expressed here are my own, and do not necessarily reflect the views of my employer”.’

However, the social media ‘Dos and don’ts’ reference card (UK/IE MAT-19232, August 2018) stated, amongst other things:

‘Act as an ambassador for LEO Pharma UK/IE e.g. update your LinkedIn profile to All-Star status, like and engage with our social media posts.’

The Panel noted that although a number of email communications with more specific instructions about certain posts had been sent in 2020, some employees would likely be confused by the contradictory and unclear instructions.

The Panel noted its comments and rulings above which included multiple breaches of the Code including promoting a medicine prior to the grant of its marketing authorisation and considered that Leo had brought discredit upon and reduced confidence in the pharmaceutical industry. A breach of Clause 2 was ruled. This ruling was unsuccessfully appealed by Leo.