cases

Title 1,Title 2,Received,Case Number,Applicable Code Year,Completed,No breach Clause(s),Breach Clause(s),Sanctions Applied,Additional Sanctions,Appeal,Website Link,Case Summary
AUTH/3595/1/22 and AUTH/3596/1/22 - Complainant v Bristol Myers-Squibb and Pfizer,Concerns about Eliquis Website,04-Jan-22,AUTH/3595/1/22 AND AUTH/3596/1/22,2021,09-Mar-23,"2, 6.1","5.1, 6.1",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3595122-and-auth3596122-complainant-v-bristol-myers-squibb-and-pfizer//,"This case was in relation to four patient information booklets on the Bristol Myers-Squibb and Pfizer Eliquis (apixaban) website which were not updated following updates to the Eliquis Summary of Product Characteristics (SPC).
The Panel ruled a breach of the following Clause(s) of the 2021 Code in relation to each of the four booklets for failing to include certain information following updates to the SPC which meant that the booklets were inaccurate or misleading:
Breach of Clause 6.1
Including misleading and inaccurate information
Breach of Clause 5.1
Failing to maintain high standards
The Panel ruled no breach of the following Clause(s) of the 2021 Code in relation to each of the four booklets as in its view failure to include certain information following updates to the SPC did not mean that the booklets were inaccurate or not up-to-date as alleged and the Panel did not consider that the complainant had established that patient safety had been prejudiced:
No Breach of Clause 6.1
Requirement that information must be accurate, up-to-date and not misleading
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
This summary is not intended to be read in isolation."
AUTH/3597/1/22 - Complainant v AstraZeneca,AstraZeneca on LinkedIn,05-Jan-22,AUTH/3597/1/22,2021,08-Aug-23,"2, 3.3, 5.1, 6.2, 8.3, 26.1, 26.2",5.1,Undertaking received,,Appeal by respondent,https://www.pmcpa.org.uk/cases/completed-cases/auth3597122-complainant-v-astrazeneca/,"This case was in relation to two posts on LinkedIn and a BBC Radio 4 interview about AstraZeneca and an alleged breach of undertaking . 
The Panel ruled a breach of the following Clause(s) of the 2021 Code on the basis that:
The first LinkedIn post in question by a very senior AstraZeneca UK employee which included a link to an inews article promoted AstraZeneca’s Covid-19 vaccine prior to the grant of its marketing authorisation (Matter 1)
A UK-based global employee’s like of the second LinkedIn post disseminated positive information about Evusheld to the employee’s connections and promoted the medicine prior to the grant of its marketing authorisation (Matter 2)The Panel considered, noting the content of the video transcript provided by AstraZeneca in relation to the BBC interview, that the interview given by the very senior AstraZeneca employee had promoted AstraZeneca’s Covid-19 vaccine prior to the grant of its marketing authorisation (Matter 3) The Panel noted its three rulings of a breach of high standards in relation to the promotion of an unlicensed medicine in the three separate matters above, two of which resulted from the actions of very senior employees and it appeared that in relation to the first LinkedIn post both a very senior employee and AstraZeneca had failed to recognise the promotional nature of the LinkedIn post resulting in the placement of an uncertified promotional post on the senior employee’s personal LinkedIn account. 
Breach of Clause 5.1
(Successfully appealed in Matters 1 and 3. Unsuccessfully appealed in Matter 2)
Failing to maintain high standards
Breach of Clause 2
(Successfully appealed )
Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
The Panel ruled no breach of the following Clause(s) of the 2021 Code on the basis that:
the matters before it in this case were sufficiently different to Case AUTH/3412/10/20 such that there had been no breach of the undertaking given in that case,
the complainant had not established that the BBC interview had been used in many other publications which showed lax processes or that statements made during the interview were not capable of substantiation,
Clause 8.3 was not relevant as in the Panel’s view the two LinkedIn posts and interview were promotional, and
Clauses 26.1 and 26.2 only applied to prescription only medicines and neither AstraZeneca’s Covid vaccine was not classified as such at the time the first LinkedIn post was made or the interview took place and an edited video of it was hosted on the BBC website and nor was Evusheld at the time the second LinkedIn post was liked by the UK-based employee.
No Breach of Clause 2
Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 3.3
Requirement to comply with an undertaking
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 6.2
Requirement that information must be capable of substantiation
No Breach of Clause 8.3
Requirement to certify non-promotional material
No Breach of Clause 26.1
Requirement not to advertise prescription only medicines to the public
No Breach of Clause 26.2
Requirement that information about prescription only medicines which is made available to the public must be factual, balanced, must not raise unfounded hopes of successful treatment or encourage the pubic to ask their health professional to prescribe a specific prescription only medicine
APPEAL 
The Panel’s ruling of a breach of Clause 5.1 in relation to Matters 1 and 3 was overturned and upheld in relation to Matter 2 at appeal. The Panel’s overall ruling of a breach of Clause 2 in relation to Matters 1-3 was overturned at appeal. 
This summary is not intended to be read in isolation."
AUTH/3599/1/22 - Hospital consultant v AstraZeneca,"Alleged promotion of Forxiga, Lisinopril and other medicines on LinkedIn and declarations of interest",16-Jan-22,AUTH/3599/1/22,2021,11-Apr-23,"2, 26.1, 26.2, 5.5","5.1, 26.1, 26.2",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3599122-hospital-consultant-v-astrazeneca/,"This case related to the alleged promotion of Forxiga (dapagliflozin), lisinopril and other medicines on LinkedIn and declarations of interests in a published paper.
The Panel ruled a breach of the following Clauses of the 2021 Code in relation to an AstraZeneca employee, in contravention of UK company policy, liking and commenting on a LinkedIn post about dapagliflozin, thereby disseminating information about a prescription only medicine to members of the public, which may have encouraged members of the public to ask their health professional to prescribe it.
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 26.1
Advertising a prescription only medicine to the public
Breach of Clause 26.2
Encouraging members of the public to ask their health professional for a specific prescription only medicine
The Panel ruled no breach of the following Clauses of the 2021 Code in relation to an allegation that an AstraZeneca employee had promoted named AstraZeneca prescription only medicines to the public in LinkedIn posts, that a post was not factual or balanced, that a post raised unfounded hopes of successful treatment, and that the conflict of interest declaration of the employee was not clear.
No Breach of Clause 5.5
Requirement to clearly indicate the role of the pharmaceutical company
No Breach of Clause 26.1
Requirement to not advertise prescription only medicines to the public.
No Breach of Clause 26.2
Requirement that information about prescription only medicines which is made available to the public must be factual, balanced, must not raise unfounded hopes of successful treatment or encourage the public to ask their health professional to prescribe a specific prescription only medicine.
Overall, the Panel considered that the rulings of breaches of the Code adequately covered the matter and an additional ruling of a breach of Clause 2 would be disproportionate in the particular circumstances of this case.
No Breach of Clause 2 
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry.
This summary is not intended to be read in isolation."
AUTH/3601/1/22 - Complainant v Boehringer Ingelheim,Advertisement for Trajenta,20-Jan-22,AUTH/3601/1/22,2021,20-Feb-23,14.4,,,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3601122-complainant-v-boehringer-ingelheim/,"This case was in relation to the use of the word ‘unique’ in the claim ‘Unique convenience through always one dose, once daily’ within a dynamic digital banner advertisement for Trajenta (linagliptin) issued by Boehringer Ingelheim Limited.
The Panel ruled no breach of the following Clause(s) of the 2021 Code, as it did not consider that the complainant had established that the claim ‘Unique convenience through always one dose, once daily’ in relation to Trajenta, within the context of type 2 diabetes mellitus, implied a special merit that could not be substantiated:
No Breach of Clause 14.4
Requirement that claims should not imply that a medicine or an active ingredient has some special merit, quality or property unless this can be substantiated.
This summary is not intended to be read in isolation."
AUTH/3602/1/22 - Complainant v Teva,Concerns regarding Ajovy website www.ajovy.co.uk,20-Jan-22,AUTH/3602/1/22,2021,14-Mar-23,"12.3, 12.1, 26.4",,,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3602122-complainant-v-teva/,"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."
AUTH/3603/1/22 - Complainant v Gilead,Concerns about a Gilead Europe website,20-Jan-22,AUTH/3603/1/22,2021,22-Mar-23,2,"5.1, 12.1, 12.3, 12.1, 26.1, 26.2",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3603122-complainant-v-gilead/,"This case was in relation to Gilead Sciences Europe’s website HIV.eu.
The Panel ruled a breach of the following Clause(s) of the 2021 Code for failing to include obligatory information and because on the balance of probabilities, promotional information aimed at health professionals was available to members of the public:
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 12.1
Failing to include up-to-date prescribing information
Breach of Clause 12.3
Failing to include the non-proprietary name
Breach of Clause 12.10
Failing to include the black triangle
Breach of Clause 26.1
Advertising prescription only medicines to the public
Breach of Clause 26.2
Encouraging members of the public to ask for a specific prescription only medicine
The Panel ruled no breach of the following Clause(s) of the 2021 Code because it considered that the rulings of breaches adequately covered this matter:
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
This summary is not intended to be read in isolation."
AUTH/3604/1/22 - Complainant v Novo Nordisk,Concerns about promoting to the public on LinkedIn,20-Jan-22,AUTH/3604/1/22,2021,20-Feb-23,"2, 5.1, 8.3, 26.1",5.1,Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3604122-complainant-v-novo-nordisk/,"This case was in relation to a LinkedIn post by an individual based in the UK and contracted to work for Novo Nordisk A/S via a third-party company. The LinkedIn post mentioned a study that was to be conducted on Novo Nordisk’s treatment, oral semaglutide and included a linked article.
The Panel ruled a breach of the following Clause(s) of the 2021 Code for failing to certify the promotional LinkedIn post in line with Clause 8.1:
Breach of Clause 5.1
Failure to maintain high standards
The Panel ruled no breach of the following Clause(s) of the 2021 Code on the basis that the LinkedIn post was promotional and that oral semaglutide 50mg was not classified as a prescription only medicine at the time:
No Breach of Clause 8.3
Requirement to certify non-promotional material
No Breach of Clause 26.1
Requirement to not advertise prescription only medicines to the public
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry 
This summary is not intended to be read in isolation."
AUTH/3606/1/22 - Health professional v Accord,Promotion of Sixmo and use of market research outcomes,24-Jan-22,AUTH/3606/1/22,2021,06-Oct-22,"2, 5.1, 5.2",,,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3606122-health-professional-v-accord/,"A health professional complained about the promotion of the buprenorphine implant, Sixmo following his/her participation in a market research campaign by Accord UK Ltd.
Sixmo 74.2mg implant was indicated for substitution treatment for opioid dependence in clinically stable adult patients who required no more than 8mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.
The complainant alleged that this ill-conceived campaign was derogatory as it treated patients with addiction as puppets. Talking to colleagues, the complainant knew that this view was a consensus. The complainant was therefore shocked that, despite the feedback, Accord had progressed with this demeaning campaign. The complainant alleged that by treating patients this way and not listening to advice it sought that Accord had not maintained high standards and the material caused offence to the complainant as a prescriber on behalf of his/her patients who had been depicted condescendingly. The complainant also alleged that by not acting on market research feedback, Accord had also breached Clause 2 and had brought the industry into disrepute.
The detailed response from Accord is given below.
The Panel acknowledged that extreme dissatisfaction was usually necessary on the part of an individual before he or she was moved to submit a complaint.
The Panel noted that the complainant had not provided any of the materials about which he/she was concerned. In reviewing the material provided by Accord, the Panel noted that the health professional leave piece (Ref UK-03077 Date of preparation: September 2021) was headed ‘Help to cut the ties that addiction brings’ followed by an image of a puppet of a male painter and decorator in dungarees with some strings attached to a winding mechanism (which appeared would make the puppet move) and other strings cut. A later page within the leavepiece included the same heading as the first page followed by a list of features of the medicine with an image this time of the same puppet dressed smarter in a shirt and no longer connected to a winding mechanism. A similar theme was used in other material (ref UK-03319, Health & Justice Exhibition Stand) which also included the heading ‘Help to cut the ties that addiction brings’ and images of two different puppets, a female and a male, and referred to six reasons to use Sixmo.
The Panel accepted that some health professionals would be critical of the campaign and noted that whilst some negative comments were reported from the market research, there were also positive comments. Around 67% of the UK participants in the market research either liked it, mostly liked it or very much liked it. The intended audience, those treating addiction, would, like any audience, have different views about sensitive subjects. It was not clear whether the complainant was referring to the comments from colleagues involved in the market research or colleagues who had seen the campaign generally as the consensus view that the campaign was ill-conceived. In any event, the campaign did not appear to be inconsistent with the market research. The Panel noted Accord’s submission that it had made changes to the campaign as a result of the market research.
The Panel noted the submission from Accord about patients being controlled by their addiction. The material included the explanation about cutting the ties of addiction and in the Panel’s view, on the evidence provided, it did not appear to be an unreasonable approach to treating addiction. The Panel considered that although some readers might not like the campaign and would be offended, the Panel did not consider that the campaign did not recognise the special nature of medicines nor did it fail to respect the professional standing or otherwise of the audience. In the Panel’s view, the campaign was not likely to cause offence to most of the audience and the Panel did not consider that Accord had failed to maintain high standards. No breaches of the Code were ruled including no breach of Clause 2."
AUTH/3608/2/22 - Complainant v AstraZeneca,Alleged promotion to the public on LinkedIn,08-Feb-22,AUTH/3608/2/22,2021,21-Nov-22,"2, 5.1, 11.1, 26.1",,,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3608222-complainant-v-astrazeneca/,"A contactable complainant, who described himself/herself as a medical oncologist, alleged that AstraZeneca had promoted its current and future pipeline to the public on LinkedIn.
The post in question was from a named senior employee and referred to AstraZeneca helping lead a revolution in oncology. The post referred to world cancer day as the perfect time to reflect on the achievements made across the cancer community and to thank everyone from charities, volunteers, healthcare workers, scientists, the NHS and other pharmaceutical companies for ‘the sheer dedication and resilience they bring to making the world slightly better for those people living with cancer’. It went on to state that AstraZeneca was proud of its work developing innovative medicines that bring hope to people living with cancer and introducing initiatives that can improve outcomes and redefine cancer care. The post referred to the challenges ahead and that AstraZeneca had a team which came together every day to find ways to overcome the challenges and move towards a world without cancer. The post referred to helping raise awareness of world cancer day by sharing Cancer Research UK’s (CRUK’s)post and reflect on what this day meant to readers.
The complainant was absolutely disgusted at the manner in which such a senior person at AstraZeneca UK would use World Cancer day to share a live link to the AstraZeneca Oncology portfolio and pipeline, via his/her LinkedIn profile, effectively promoting current and future pipeline products to the general public.
The complainant stated that this type of reckless behaviour undermined the important work at a named London hospital, where a large clinical trial centre would have patients coming in with screenshots of the AstraZeneca pipeline, requesting access to phase 1, 2, and even 3 molecules, whose efficacy and safety was not yet proven.
The complainant alleged that this raised unfounded hopes for patients, trivialised the important work done and promoting unproven assets (in some cases) to the public was just not ethical medicines promotion.
Additionally, the complainant was baffled that so many AstraZeneca staff members had liked the post. There seemed to be a big problem at AstraZeneca UK Oncology, with respect to appropriate promotion, to suitable audiences, once a licence had been granted. The complainant alleged one could argue that this case represented the worst example of (i) promotion to the public (ii) promotion prior to licensing of combinations.
The detailed response from AstraZeneca is given below.
The Panel noted that the LinkedIn post in question did not refer to AstraZeneca medicines by name or by indication. According to AstraZeneca, there was not a direct link from the LinkedIn post to the information about the company’s pipeline. The post included a link to the AstraZeneca Global LinkedIn account. The Panel noted, therefore, that someone reading the post in question would have to follow the link to the AstraZeneca Global LinkedIn account and then link to the AstraZeneca corporate website and then decide to actively access the information about the company’s pipeline in order to see that information. The Panel noted that the AstraZeneca Global corporate website landing page featured a number of items with links to further information including the projects in the pipeline (177).
The Panel noted that it was likely that some patients with cancer would search for information about oncology studies and some would request pipeline products. The Panel, however, did not consider that the AstraZeneca employee’s LinkedIn post in question or AstraZeneca employees’ ‘liking’ the post promoted AstraZeneca’s oncology current portfolio or its future pipeline products prior to the grant of the product’s marketing authorisation to the public as alleged. The Panel therefore ruled no breaches of the Code.
The Panel did not consider that the complainant had established that the LinkedIn post in question raised unfounded hopes for patients or trivialised work done by a named London hospital as alleged. The Panel ruled no breach of the Code in relation to each allegation.
The Panel noted its comments and rulings above and consequently ruled no breach of Clause 2."
AUTH/3609/2/22 - Voluntary admission by Britannia Pharmaceuticals,Incorrect prescribing information on the APO-go website,08-Feb-22,AUTH/3609/2/22,2021,02-Nov-22,"2, 5.1, 26.1, 26.4",12.1,Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3609222-voluntary-admission-by-britannia-pharmaceuticals/,"Britannia Pharmaceuticals Ltd made a voluntary admission about incorrect prescribing information on the APO-go (apomorphine hydrochloride) website which was developed by a third-party contractor. The third party was, according to Britannia, responsible for hosting the APO-go website, the execution of the general design and layout of the website and making amendments to content when requested by Britannia. Britannia had no back-end access to the website.
Britannia stated that the most recent change to the webpage content was in November 2021 to the healthcare professional/patient/general public landing page. The previous update was in June 2021.
On 1 February 2022 the Britannia compliance team noticed that the pdfs available in the ‘Resources’ tab under the ‘Healthcare Professional (HCP) only’ section of the website could be accessed directly from Google when ‘Crono pump’ or ‘APO-go pen’ were typed in the search engine. The material was intended to be downloaded by the health professional and then provided to patients prescribed APO-go, to educate them on the use of the device.
Britannia stated that on investigation the third party confirmed that a new developer uploaded the updated versions of the materials, however, when completing the update, the developer accidently left the access to the new versions of the pdfs open via the backend. Britannia confirmed that these materials were non-promotional and had no risk to patient safety.
On becoming aware of the issue Britannia immediately contacted the third party agency to remove the old pdf version of the material from the server and remove access to the new pdf versions of the materials that could be accessed through Google search engine.
The third party actioned the above immediately, however, during this process, the third party inadvertently removed the prescribing information document from the server but did not inform Britannia as the error was unknown to the third party. The prescribing information tab was available at the bottom of the landing page. However, when clicking on it, the prescribing information was inaccessible and an error message was seen on the page.
On 2 February, Britannia identified that the prescribing information was inaccessible via a spot check and contacted the third party immediately to reinstate the prescribing information which was done that day.
Britannia provided details of the actions taken and the preventative measures that had been put in place.
Britannia submitted that the third party reinstated the prescribing information within two hours of Britannia becoming aware of the issue. This was an error wholly made by the third party and not one instructed or made by Britannia, although the company accepted that it had responsibility for third party contracts. Hence why Britannia made the voluntary submission.

The detailed response from Britannia is given below.
The Panel noted that neither Britannia nor its third party were aware that the APO-go prescribing information was inadvertently removed by the third party whilst the errors described below were corrected. This resulted in the prescribing information being unavailable on the Britannia APO-go promotional website, albeit for a short period of time. The Panel therefore ruled a breach of the Code as acknowledged by the company.
In relation to the clauses raised by the case preparation manager, the Panel noted that on 1 February 2022, the Britannia compliance team noted that three documents available in the ‘Resources tab’ under the ‘Healthcare Professional (HCP) only’ section of the website, could be accessed directly from Google search engine when ‘Crono pump’ or ‘APO-go pen’ were typed as keywords. According to Britannia, when uploading the updated versions of the materials, the third party accidently left access to these new pdf versions open via the backend. They were not intended to be disseminated on a public domain.
The documents were according to Britannia non-promotional device guidance materials which were intended to be downloaded by health professionals to provide to patients when they were prescribed APO-go to educate them on the use of the device.
The Panel noted that whilst the three old versions of the documents had been withdrawn from the APO-go website, they were accidently not removed from the backend server by the website developer. These old versions of the documents were available in the public domain when proactively searched but were not available on the APO-go website. In that regard, it seemed reasonable to consider that the documents were on an internal company page rather than one which was intended for an external audience including the public.
The Panel, noting its comments above, decided that in the particular circumstances of this case, the now out-of-date yellow card link on the three old versions of the documents which were not ‘live’ on the company website did not amount to a breach of the Code. No breach of the Code was ruled.
Similarly, although it was unfortunate that the three old versions of the documents could be accessed by members of the public via Google, the Panel noted that they could not be accessed directly from Britannia’s website; they were stored in an area that was not intended to be accessible to users outside of the company. On balance, the Panel considered that the circumstances of this case the three old versions of the documents, which had been removed from the APO-go website but which had unintentionally, and unknown to Britannia, remained directly accessible by Google, did not amount to the promotion of a prescription-only medicine to the public. No breach of the Code was ruled.
The Panel noted Britannia’s submission that it changed the medical information number and that both the old version of the ‘Pump Programming Guide’ and new version of the document ‘Infusion Programming Guide’ had the old number. The Panel further noted Britannia’s submission that both numbers were currently active with the old number automatically redirected to the new number to ensure that no enquiries were missed. The Panel decided that in the particular circumstances of this case, the old medical information number still being available on old and new versions of the documents at issue did not amount to a failure to maintain high standards and no breach of the Code was ruled.
In relation to the three new versions of the documents that could be accessed via google search, the Panel noted that they were live on the APO-go website. The Panel further noted Britannia’s submission that these materials could only be accessed when keywords, such as ‘Crono pump’ or ‘APO-go pen’, were proactively searched in Google. According to Britannia as these keywords were typically used by patients or prescribers who were familiar with the product, it would be highly unlikely for members of the public to come across these materials without proactively searching using the keywords in Google search engine. In order to access such materials on the APO-go website, users needed to confirm that they were a health professional. Communications between Britannia and the third party in May 2021 stated that the ‘Are you an HCP’ banner was not visible from Google from all pages and Britannia requested that the third party add the health professional link to all Google entry points. It appeared from this communication that when accessing the APO-go PEN link from Google, the health professional pop up appeared and when it did not it was noted that this was probably because the user had already visited the site previously and confirmed that they were a health professional which the site remembered. The Panel did not consider that there was evidence to show that a Google search for ‘Crono pump’ or ‘APO-go pen’ took browsers straight to the three new versions of the documents without a health professional declaration. The Panel, noting its comments above, did not consider that prescription only medicines had been promoted to the public. The Panel ruled no breach of the Code.
In the Panel’s view, this case illustrated that companies should exercise extreme caution and, wherever possible, ensure that material which was withdrawn from use was either removed from the internet or securely hidden from view and thus inaccessible by people outside of the company.
The Panel noted Britannia’s submission that it took immediate action to correct the issues when becoming aware of them. Although concerned that at the time of the complaint the three old versions of the documents could still be found via a Google search as well as the three new versions, given its comments and rulings above, the Panel considered that, in the specific circumstances of this case, the company had not failed to maintain high standards. No breach of the Code was ruled. The Panel consequently ruled no breach of Clause 2."
AUTH/3611/2/22 - Complainant v Daiichi Sankyo,Electronic guidelines card for Nilemdo and Nustendi,14-Feb-22,AUTH/3611/2/22,2021,23-Feb-23,"6.1, 11.2","2, 5.1, 6.1, 6.2",Undertaking received,Advertisement,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3611222-complainant-v-daiichi-sankyo/,"This case was in relation to a NICE technology appraisal summary card for Nilemdo (bempedoic acid) and Nustendi (bempedoic acid and ezetimibe), produced as promotional material by Daiichi Sankyo, which allegedly did not mention the contraindication with simvastatin >40mg nor the importance of seeing Sections 4.2, 4.3, and 4.4 of the Summary of Product Characteristics (SPC).
The Panel ruled a breach of the following Clause(s) of the 2021 Code for failing to make immediately apparent to health professionals in promotional material which referred to the therapeutic use of Nilemdo or Nustendi in combination with a statin that there was a contraindication regarding concomitant use with simvastatin >40mg daily:
Breach of Clause 6.1
Misleading impression provided
Breach of Clause 6.2
Misleading impression incapable of substantiation
Breach of Clause 5.1
Failure to maintain high standards
Breach of Clause 2
Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
The Panel ruled no breach of the following Clause(s) of the 2021 Code based on the complainant not having established, on the very narrow allegation, that there was ‘no mention at all anywhere on the card about the contraindication with simvastatin >40mg’, nor that by not instructing the reader to view Sections 4.2, 4.3 and 4.4 of the SPC meant that Nilemdo and Nustendi had been promoted outside the terms of their licences as alleged:
No Breach of Clause 6.1
The requirement to not mislead either directly or by implication, by distortion, exaggeration or undue emphasis
No Breach of Clause 11.2
The requirement for promotion to not be inconsistent with the SPC
This summary is not intended to be read in isolation."
AUTH/3649/5/22 - Health professional v Daiichi Sankyo,SMC Guidelines card for Nilemdo and Nustendi,14-Feb-22,AUTH/3649/5/22,2021,23-Feb-23,"6.1, 6.2","2, 3.3, 5.1, 6.1",Undertaking received,Advertisement,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3649522-health-professional-v-daiichi-sankyo/,"This case was in relation to a Scottish Medicines Consortium (SMC) Guidelines summary card for Nilemdo (bempedoic acid) and Nustendi (bempedoic acid and ezetimibe), produced as promotional material by Daiichi Sankyo.
The Panel ruled a breach of the following Clauses of the 2021 Code for failing to make immediately apparent to health professionals in the body of promotional material, which referred to the therapeutic use of Nilemdo or Nustendi in combination with a statin, that there was a contraindication regarding concomitant use with simvastatin >40mg daily, and for failing to comply with an undertaking given in Case AUTH/3504/4/21:
Breach of Clause 3.3
Failure to comply with an undertaking
Breach of Clause 6.1
Misleading impression provided
Breach of Clause 5.1
Failure to maintain high standards
Breach of Clause 2
Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
The Panel ruled no breach of the following Clauses of the 2021 Code as the complainant had not established that the material was incapable of substantiation nor that the omission in the body of the material of the contraindication for Nustendi when co-administered with a statin in patients with active liver disease or unexplained persistent elevations in serum transaminases meant the material was misleading, given the material did not imply there were no liver disease considerations:
No Breach of Clause 6.1
Requirement that claims must not be misleading
No Breach of Clause 6.2
Requirement that claims must be capable of substantiation
This summary is not intended to be read in isolation."
AUTH/3612/2/22 - Complainant v Daiichi Sankyo,Promotion of Nilemdo and Nustendi at a symposium,19-Feb-22,AUTH/3612/2/22,2021,23-Feb-23,"2, 5.1, 11.2, 12.5, 26.1","2, 5.1, 12.5",Undertaking received,Advertisement,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3612222-complainant-v-daiichi-sankyo/,"This case was in relation to a live and on-demand promotional symposium for Nilemdo (bempedoic acid) and Nustendi (bempedoic acid and ezetimibe) which allegedly did not mention that both medicines were contraindicated with simvastatin >40mg on the indications slide and this was allegedly inconsistent with each medicine’s marketing authorisation. The complainant further alleged that the prescribing information was displayed for an insufficient amount of time and that the recording of the presentation was accessible on an open access platform.
The Panel ruled a breach of the following Clause(s) of the 2021 Code for failing to make the contraindication with simvastatin >40mg immediately apparent when presenting Nilemdo and Nustendi’s indications which referred to their therapeutic use in combination with a statin; and for failing to display prescribing information for adequate time for each medicine during the live symposium:
Breach of Clause 5.1
Failure to maintain high standards
Breach of Clause 2
Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Breach of Clause 12.5
Failing to display prescribing information for sufficient duration so that it is easily readable
The Panel ruled no breach of the following Clause(s) of the 2021 Code based on the complainant not having established that:
A lack of reference to Section 4.3 of the SPC meant that Nilemdo and Nustendi had been promoted inconsistently with their SPCs as alleged; nor that the prescribing information for each medicine, which could be paused by the viewer in the on-demand recording, was displayed for insufficient time; nor that the on-demand recording, which was hosted privately, and accessible from the on-demand section of the society’s website where members had to self-certify that they were health professionals, constituted promotion of a prescription only medicine to the public; nor that information had been made available to the public:
No Breach of Clause 11.2
The requirement for promotion to not be inconsistent with the SPC
No Breach of Clause 12.5
Requirement to display prescribing information for sufficient duration so that it is easily readable
No Breach of Clause 26.1
Requirement not to advertise prescription only medicines to the public
No Breach of Clause 5.1 
Requirement to maintain high standards 
No Breach of Clause 2 
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry 
This summary is not intended to be read in isolation."
AUTH/3613/2/22 - Complainant v AstraZeneca,Allegations about promotion on LinkedIn and breach of an undertaking,21-Feb-22,AUTH/3613/2/22,,09-May-23,,,,,,https://www.pmcpa.org.uk/cases/completed-cases/auth3613222-complainant-v-astrazeneca/,No case report as outwith the scope of the Code
AUTH/3614/2/22 - Employee v Eli Lilly,Alleged conduct of an Eli Lilly employee,24-Feb-22,AUTH/3614/2/22,2021,20-Apr-23,"17.2, 17.4, 17.5",,,,Complainant appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3614222-employee-v-eli-lilly/,"This case was in relation to concerns that an employee had been asked by their manager to ‘dress down’ so as not to be so obvious as a company representative, not raise any suspicion walking the corridors of the hospitals, and to try and see customers that way.
The Panel ruled no breach of the following Clauses of the 2021 Code because based on the evidence before it, it did not consider that the complainant had established that:
• any company representative had misled as to their identity or that of the company they represented
• the wishes of individuals on whom representatives wanted to call and the arrangements in force at any particular establishment had not been observed
• any representative had not maintained a high standard of ethical conduct in the discharge of their duties or had not complied with all relevant requirements of the Code
No Breach of Clause 17.2
(Unsuccessfully appealed)
Requirement that representatives must maintain a high standard of ethical conduct in the discharge of their duties and comply with all relevant requirements of the Code
No Breach of Clause 17.4
(Unsuccessfully appealed)
Requirement that the wishes of individuals on whom representatives call and the arrangements in force at any particular establishments must be observed.
No Breach of Clause 17.5
(Unsuccessfully appealed)
Requirement that representatives must not mislead as to their identity or that of the company they represent.
APPEAL
All of the Panel’s rulings were upheld upon appeal by the complainant.
This summary is not intended to be read in isolation."
AUTH/3617/3/22 - Complainant v GlaxoSmithKline,Alleged promotion of Shingrix on LinkedIn,09-Mar-22,AUTH/3617/3/22,2021,10-Mar-23,"2, 9.1, 12.1, 26.1",,,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3617322-complainant-v-glaxosmithkline/,"This case was in relation to a post made by an individual on his/her personal LinkedIn account about starting a new role at GlaxoSmithKline and the information in the ‘Experience’ section of that account.
The Panel ruled no breaches of the following Clause of the 2021 Code in relation to the post as, at that time, GlaxoSmithKline was not the only company to have a medicine related to ‘shingles prevention’:
No Breach of Clause 26.1
Requirement not to advertise prescription only medicines to the public
The Panel ruled no breaches of the following Clauses of the 2021 Code in relation to the ‘Experience’ section of the personal LinkedIn account as it considered that the information within this section would require an individual to actively search and navigate, and to reach the ‘Experience’ section 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:
No Breach of Clause 12.1
Requirement to include prescribing information
No Breach of Clause 26.1
Requirement not to advertise prescription only medicines to the public
The Panel ruled no breaches of the following Clauses of the 2021 Code as the complainant had not established that the individual in question had not been trained, nor that GlaxoSmithKline had brought discredit upon or reduced confidence in the industry:
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry 
No Breach of Clause 9.1
Requirement that all relevant personnel concerned with the preparation or approval of material or activities covered by the Code must be fully conversant with the Code and the relevant laws and regulations
This summary is not intended to be read in isolation."
AUTH/3615/3/22 - Complainant v Daiichi Sankyo,Alleged failure to certify the mobile version of a promotional website for Lixiana,10-Mar-22,AUTH/3615/3/22,2021,02-Dec-22,"2, 5.1","8.1, 8.3",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3615322-complainant-v-daiichi-sankyo/,"An anonymous contactable complainant complained that Lixiana (edoxaban) promotional content on a website for health professionals and non-promotional content on a website for patients being used by Daiichi Sankyo had not been certified.
The complainant stated that on this homepage of the promotional website (lixiana-hcp.co.uk) (Date of preparation: March 2022 EDX/22/0052), there was a picture of patient heads at the top of the page and PINK writing to the side of the patient heads picture, which read, ‘Your choice for ageing patients with NVAF [nonvalvular atrial fibrillation]’. This image and pink writing were on the desktop view. The mobile phone view had a different image of the patient heads (some of the heads were cropped on purpose) and the writing on the mobile view for ‘Your choice for ageing patients with NVAF’ was in white versus pink on the desktop view. Despite the clear and obvious differences in the promotional view for the desktop versus mobile version, the mobile version had not been approved separately. The codes and date of preparation on both desktop and mobile were the same but this was inappropriate due to the need to undertake separate approval on both desktop and mobile separately.
The complainant alleged that problems with the cropped image and the writing were also an issue on the three other pages. Therefore, in total, 4 pages of the promotional website were actually not certified for use on mobile phone due to the differences in the images of the patient heads and the colour of writing versus the desktop look.
The complainant stated that the patient website for Lixiana https://myanticoagulant.co.uk/nvaf/ (Date of preparation: February 2022 – EDX/21/0963), had similar issues in that there were two pictures on this page of a fictional female patient on the desktop view. However, on mobile phone, these two pictures of the female patient were totally different to the ones used on the desktop. Therefore, there should have been two different approvals and certification for mobile and desktop views.
The complainant referred to https://myanticoagulant.co.uk/vte/ (Date of preparation: February 2022 – EDX/21/0963) and stated that on this page, there were two images of a male fictional patient on the desktop. On mobile, the two images of the male fictional patient were totally different to the ones used on desktop. Therefore, there should have been two different certifications for the mobile and desktop but this had not been done.
The detailed response from Daiichi Sankyo is given below.
Health professional webpages
The Panel noted that the differences between the desktop and mobile versions highlighted by the complainant were in relation to the illustration of patient heads which appeared cropped in the mobile version and that the claim ‘Your choice for ageing patients with NVAF’ was in pink on the desktop view and in white on the mobile view on four separate webpages on the lixiana-hcp.co.uk website.
Daiichi Sankyo had not disputed that there were differences in this regard. The question for the Panel was whether the differences meant that there were two final forms, ie one for the desktop version and one for the mobile version and, if so, each would need to be separately certified.
In the Panel’s view, the Code did not necessarily require a website to be certified multiple times for each different device it might be viewed upon, however, it considered that the appearance of the material on different devices should be taken into consideration prior to certification to ensure that the content met the requirements of the Code when viewed on each different commonly used type of electronic device, eg desktop, laptop, tablet, smartphone etc.
The Panel noted Daiichi Sankyo’s submission that the changes to the positioning of images on the mobile version at issue served to ease usability and readability on mobile devices and did not change the content, meaning or perception from that delivered by the desktop imagery.
The Panel considered, however, that whilst it appeared that in this instance the final form of the material as it would appear on mobile devices was reviewed by the Daiichi Sankyo signatory as part of the final check under the same job bag number in relation to all four webpages, the webpages were not identical on each platform; the colour used for the claim was different on each and therefore it considered that the final form differed for the mobile version compared to the desktop version and therefore each should have been certified separately which had not occurred. The Panel therefore ruled a breach of the Code.
The Panel did not consider that the particular circumstances of this case constituted a failure to maintain high standards or a breach of Clause 2 and no breaches were ruled in that regard.
Patient webpages
The Panel noted that the differences between the desktop and mobile versions highlighted by the complainant were in relation to the use of completely different illustrations of patients. The Panel noted that the desktop version had 2 images, each of an elderly woman and man looking straight ahead, one from a front angle and one from a side angle for each individual. The images appeared to be different to those used on the mobile website, which had two images each of the same elderly woman and man looking upwards from a front and side angle.
Daiichi Sankyo had not specifically commented on the use of different illustrations but had not disputed that there were differences in this regard. The question for the Panel was whether the differences meant that there were two final forms, ie one for the desktop version and one for the mobile version and, if so, each would need to be separately certified.
The Panel considered that the images formed part of the content on the page and that these differed based on the platform it was viewed on. Whilst the Panel noted that the mobile website was reviewed as part of the same job bag, it considered that the final form differed for the mobile version compared to the desktop version and therefore each should have been certified separately which had not occured. A breach of the Code was ruled.
The Panel did not consider that the particular circumstances of this case constituted a failure to maintain high standards or a breach of Clause 2 and no breaches were ruled in that regard."
AUTH/3618/3/22 - Complainant v AstraZeneca,Promotion of Forxiga,11-Mar-22,AUTH/3618/3/22,2021,03-Apr-23,"6.2, 17.9","2, 5.1, 6.1, 6.2, 11.2, 14.4",Undertaking received,Advertisement,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3618322-complainant-v-astrazeneca/,"This case was in relation to dosage claims about Forxiga (dapagliflozin) made by a representative and on a promotional website.
The Panel ruled a breach of the following Clause(s) of the 2021 Code in relation to the claims ‘Start FORXIGA 10mg today’ and ‘FORXIGA 10mg. Simple once-daily dosing – start on 10mg, stay on 10mg, no need for uptitration’, which had important qualifying safety information about a lower 5mg starting dose for patients with severe hepatic impairment in a small footnote that could have easily been missed:
Breach of Clause 2
Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 6.1
Providing misleading information
Breach of Clause 6.2
Providing misleading information which was not capable of substantiation
Breach of Clause 11.2
Promotion inconsistent with the summary of product characteristics
Breach of Clause 14.4
Not encouraging the rational use of a medicine
The Panel ruled no breach of the following Clause(s) of the 2021 Code in relation to the allegation that a claim about cardiorenal benefits was incapable of substantiation and for a lack of evidence that a representative misleadingly implied that all patients could start on Forxiga 10mg without referring to the lower 5mg starting dose required for patients with severe hepatic impairment:
No Breach of Clause 6.2
Requirement that information, claims or comparisons must be capable of substantiation
No Breach of Clause 17.9
Requirement that representatives’ briefing material must comply with the relevant requirements of the Code
This summary is not intended to be read in isolation."
AUTH/3620/3/22 - Complainant v Strides,Promotion of Strivit,15-Mar-22,AUTH/3620/3/22,2021,01-Nov-22,,"5.1, 6.1",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3620322-complainant-v-strides/,"An anonymous, contactable complainant who described him/herself as a pharmacist complained about the promotion of Strivit (colecalciferol, vitamin D3) by Strides Pharma UK Ltd. The complaint was forwarded to the PMCPA by The Medicines and Healthcare products Regulatory Agency (MHRA).
The complainant included a poster with the claim ‘suitable for vegetarians’ and stated that he/she had found that the product contained gelatin derived from beef bones. The complainant referred to an email from Strides which stated that, as per European law, the gelatin in Strides capsules was suitable for vegetarians as it used lime bone gelatin and not meat-sourced gelatin. However, the product was not suitable for vegans. The email further explained that the limed bone gelatin was from beef bones and cartilages and not meat which was why the company had the halal and kosher status. This was said to be the same as a vegetarian diet including dairy and eggs (from animals but not meat).
The complainant stated that Strides was claiming that as the gelatin was not from meat, it could be classed as vegetarian. However, the Vegetarian Society UK, advised that vegetarians did not eat products or by-products of slaughter.
The complainant alleged that patients and health professionals might be misled by Strides’ claim that the product was vegetarian when it was not.
The detailed response from Strides is given below.
The Panel noted that the advertisement at issue was headed ‘Switch & save 30% with … StritvVit D3’ and listed bullet points, including that StritVit was ‘Nut and soya free, suitable for vegetarians’ and ‘Kosher and Halal certified’.
The Panel noted the certificate of suitability, which appeared to have been provided to the complainant by Strides, stated that the gelatin was limed bone gelatin and the nature of animal tissues used in manufacture was bovine bones free from skulls, spinal cord and vertebrae.
The Panel noted that an email to the complainant, in response to a request, stated that StritVit was not suitable for vegans but was suitable for vegetarians: ‘Ours is limed bone gelatine from beef bones and cartilages (not meat) hence why we also have the halal and kosher status. This is the same as vegetarian diet including dairy and eggs (from animals but not meat)’.
The Panel noted Strides’ submission which included that defining a vegetarian was a difficult issue, with special reference to variation among different religious beliefs present, there were several types of vegetarians. Some ate dairy foods, others might choose to include eggs, while others abstained entirely from any food product that came from an animal. Further, that such questions had not been the focus of systematic empirical research and, in the company’s view, could not be answered conclusively.
The Panel considered that given the sensitivity of claims regarding the vegetarian status of medicines and their importance to particular health professionals and patients, such statements needed to be clear and accurate so there was no potential to mislead. It noted that Strides withdrew the claim in April 2022.
In the Panel’s view, whilst it acknowledged that there were various definitions for a vegetarian, the claim that StritVit was vegetarian would likely be interpreted by health professionals, and the wider public in the UK, as being free from gelatin from animals. It considered that, in general, vegetarians would view products from animals such as milk and eggs differently to products from animal bones, etc. The Panel considered that, in the circumstances, the claim that StritVit was vegetarian was misleading. A breach of the Code was ruled. The Panel, noting the sensitivities associated, considered that high standards were not maintained by Strides in that regard and ruled a breach of the Code accordingly."
AUTH/3621/3/22 - Complainant v Chiesi,Concerns about an invitation to MIMS Live Digital Event,15-Mar-22,AUTH/3621/3/22,2021,21-Dec-22,2,"5.1, 5.5, 10.6, 19.1",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3621322-complainant-v-chiesi/,"A contactable complainant who described him/herself as a health professional complained about an invitation to a MIMS live digital event in which there was the opportunity to win a FREE annual subscription to MIMS Learning by entering a draw and attending a session on all three days of the virtual series - for which Chiesi had a session.
The complainant stated that the Code stated the few conditions where quizzes were allowed. They should not be linked to promotion. In this case, this pecuniary advantage was linked to Chiesi’s promotion as there was no statement of involvement denouncing the company’s involvement or separating its sponsorship from such a benefit. There was no statement to show that Chiesi was not involved. It appeared to the complainant it was an inducement to attend the events which included Chiesi’s promotional session. In the full programme, it was clear that Chiesi was sponsoring the asthma session. The complainant alleged that this was clearly not in line with the Code requirements to include full unambiguous sponsorship statements. There was no sufficient sponsorship statement covering the company’s involvement in the draw. Chiesi was responsible for the acts and omission of MIMS in this case and the impression given by this email and event programme.
The detailed response from Chiesi is given below.
The Panel noted that the email at issue related to a reminder to a MIMS Live Digital Event which took place in March 2022. The Panel noted that the email was headed ‘Don’t forget, you have an upcoming event next week’ and appeared to be from a third party organising the event on behalf of MIMS.
The Panel noted that the email started by stating it was a reminder that the event was upcoming and that recipients had registered for three evenings of free CPD accredited clinical learning. The email gave details of the three day agenda; there were two presentations on the first day, a third presentation on the second day (a Chiesi presentation) and a fourth presentation on the final day. The email finished by reminding delegates that they could win a free annual subscription to MIMS learning by entering a draw and attending at least one session on each of the three days. The bottom of the email stated the event was made possible by sponsorship from a named financial company and Chiesi.
Whilst the Panel noted there was a prominent Chiesi logo at the bottom of the email, the Panel considered that this required a reader to scroll down and no reference was made to the ‘Hot topics in asthma management’ presentation on day 2 being a Chiesi presentation in the section of the email which set out the agenda for the three evenings. In the Panel’s view, the material, with the placement of the Chiesi logo at the bottom of the email, gave the impression that Chiesi had sponsored the whole event including the prize draw.
The Panel noted Chiesi’s submission about its requests to MIMS regarding the sponsorship and that the Chiesi session was promotional. The Panel noted that on one of the screenshots provided by the complainant which appeared to be the same as the programme page provided by Chiesi the Chiesi logo was placed next to the name of the relevant session and speaker photograph/details, beneath which stated, in smaller font than the rest of the section, ‘This session has been organised and funded by Chiesi Ltd and will include promotional content’.
Whilst the Panel noted that the programme page included Chiesi’s involvement, the Panel did not consider it was clear from the email invitation provided by Chiesi that the company was sponsoring one of the sessions and that this session was promotional.
The Panel did not consider that the material clearly described the role of Chiesi and ruled a breach of the Code in that regard.
In relation to the prize draw, the Panel noted the arrangements for the event as provided by Chiesi, including that it was unaware of the arrangements for the prize draw until it was notified by the PMCPA in March 2022.
With regard to whether MIMS was acting as a third party as defined in the Code, the Panel did not accept Chiesi’s submission that the relevant clause did not apply. Chiesi provided sponsorship which meant, in the Panel’s view, that the company was given certain benefits by MIMS including a 45 minute presentation at the meeting.
The Panel considered that Chiesi was responsible under the Code for the email sent by MIMS. In order to be able to enter the prize draw, a health professional had to attend at least one session each day, of which the only session on day two was the promotional presentation provided by Chiesi. Whilst it was concerning, in the Panel’s view, that Chiesi had not been informed of the prize draw, the Panel nonetheless considered that the arrangements were prohibited by the Code and ruled a breach accordingly.
The Panel considered that the arrangements for the prize draw, which required recipients to attend the Chiesi promotional session to be eligible, amounted to offering a benefit in connection with the promotion of medicines. The Panel thus ruled a breach of the Code in this regard.
The Panel noted the circumstances of this case and considered that Chiesi had been badly let down by MIMS. The Panel, nonetheless, noted its rulings of breaches as set out above, and considered that high standards had not been maintained and ruled a breach of the Code.
The Panel did not consider the circumstances amounted to a breach of Clause 2 which was a sign of particular censure. The Panel therefore ruled no breach of Clause 2."
AUTH/3622/3/22 - Complainant v AstraZeneca,Concerns about a Forxiga advertisement,15-Mar-22,AUTH/3622/3/22,2021,16-Dec-22,"2, 5.1, 6.1, 11.2",,,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3622322-complainant-v-astrazeneca/,"A complainant who described him/herself as a physician complained about an advertisement for Forxiga (dapagliflozin) on Medscape. Forxiga was marketed by AstraZeneca.
The complainant provided three screenshots of the advertisement. AstraZeneca provided the four frames for the advertisement. The frame not provided by the complainant was the first frame of the advertisement, frame 1.
The complainant was really surprised at the claims made. Although this was a rolling banner, the first one the complainant saw stated to start 10mg Forxiga in chronic kidney disease (CKD), without any qualification apart from a footnote in severe liver failure. However, there were many aetiologies of CKD that were neither covered by this licence, nor the DAPA-CKD trial. None of this was evident, it read as though Forxiga was suitable for all types of CKD, which it was not.
Moreover, these banners did not make it clear that it was only for adults. Patients who were frail and elderly also were at risk. It was not clear that there was limited evidence in patients with an eGFR <25, and many important side-effects like hypoglycemia and DKA were not highlighted other than a footnote reference to adverse events. This was a bad example of glossing over the limitations of treatment and exaggerating the breadth and effect of a medicine. It was also not clear immediately what Forxiga was, and he/she had to look further down the screen to see that it was dapagliflozin.
In another banner, a claim that Forxiga slowed eGFR decline and saved lives had zero context. It was not clear what the studied population was, and what the measured effect was. It was as though it was soliciting a click on the tab to find out more about this broad claim. In fact, the study in diabetes did not really show this, and the DAPA-CKD trial excluded both children and people without albuminuria. This was not clear from the statement ‘Forxiga slows eGFR decline and saves lives in CKD patients with T2D vs. placebo on top of standard of care’. It was not clear if the reference to CKD was related to previous banners, or if it meant only T2D patients. This made the complainant have to take the time to understand more of the licence, rather than be given the full information upfront. He/she felt that this banner solicited a click to the promotional website, by giving incomplete information. The complainant alleged this was a poor example of pharmaceutical marketing by withholding information to promote a medicine.
The detailed response from AstraZeneca is given below.
The Panel noted that the banner advertisement consisted of four frames. The first frame included Forxiga’s indication and stated ‘NEW INDICATION FORXIGA (dapagliflozin) is now approved for the treatment of CKD in patients with and without T2D’; the second frame included ‘FORXIGA slows eGFR decline and saves lives in CKD patients with T2D vs. placebo on top of standard of care’; the third frame included ‘Start on 10 mg FORXIGA, stay on 10 mg FORXIGA. Initiate Forxiga in CKD patients with eGFR ≥15 mL/min/1.73mg*’ followed by the footnote ‘*In patients with severe hepatic impairment, a starting dose of 5 mg is recommended. If well tolerated, the dose may be increased to 10 mg’; the fourth and final frame included the statement ‘The overall safety profile of FORXIGA in patients with CKD was consistent with the known safety profile of FORXIGA’ along with the button labelled ‘Discover the data now’.
The Panel noted that the complainant had not referred to the first frame of the advertisement: he/she only commented on the following three frames. In the Panel’s view, the first frame added important context to the advertisement as a whole. The four frames ie the linked parts were considered as one advertisement.
A Claims for Forxiga’s starting dose
In relation to the allegation that the claim to start on 10mg Forxiga was without qualification except in relation to severe liver failure, the Panel considered that the information on dosing in the third frame of the advertisement, was in line with the Forxiga summary of product characteristics (SPC) which required a lower starting dose of 5mg in patient with severe hepatic impairment. The Panel noted AstraZeneca’s submission that there were no requirements to reduce the dose for patients with CKD or based on renal function and/or age. The Panel did not consider that the complainant had established that the claim ‘Start on 10 mg FORXIGA, stay on 10 mg FORXIGA’, without reference to dosing in CKD, was misleading nor inconsistent with the particulars listed in the Forxiga SPC as alleged. Nor had the company failed to maintain high standards. No breaches of the Code were ruled.
B Use of Forxiga in Chronic Kidney Disease (CKD)
Whilst the Panel noted that the CKD data referred to in Section 4.4 of the SPC was clear that there was no experience of the medicine for the treatment of CKD in patients without diabetes who did not have albuminuria, the Panel noted that Forxiga was ‘indicated in adults for the treatment of chronic kidney disease’, in addition to its indications for type 2 diabetes mellitus and heart failure (Section 4.1 of the SPC). The Panel, noting Forxiga’s broad indication in CKD, did not consider that omitting a statement about evidence in CKD patients without diabetes who did not have albuminuria meant that the claims in relation to CKD were inconsistent with the SPC and were misleading in this regard as alleged. Nor had the company failed to maintain high standards. The Panel therefore ruled no breaches of the Code.
C Use of Forxiga in adults
In relation to the allegation that it was not clear that Forxiga was only to be used in adults, the Panel noted that the complainant only provided screenshots of frames 2-4, as described above, and appeared not to have seen the first frame of the advertisement where the indication was given, stating that the medicine was for use in adults. The Panel agreed with AstraZeneca’s submission that there was no implication from the images used, which were of a middle aged man, that the medicine was to be used in children. In the Panel’s view, neither the advertisement as a whole or the four individual frames appeared to be inconsistent with the SPC in this regard. Nor had the company failed to maintain high standards. The Panel therefore ruled no breaches of the Code.
D Evidence in patients with eGFR <25 mls/min and alleged failure to highlight important side-effects like hypoglycemia and DKA
The Panel noted that Section 4.2 of the Forxiga SPC stated that no dose adjustment was required based on renal function but it was not recommended to initiate treatment with in patients with an estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73m2. The Panel noted that frame 3 referred to initiating Forxiga in CKD patients with eGFR ≥15 mL/min/1.73m2 which it considered was not inconsistent with the Forxiga SPC. Thus, the Panel ruled no breach of the Code.
With regard to the allegation that many important side-effects were not highlighted, such as hypoglycemia and DKA, the Panel noted AstraZeneca’s submission that Forxiga’s safety profile had been well-established, particularly in patients with type 2 diabetes. AstraZeneca submitted it was not possible to list all known side-effects on a banner advert but there was reference to the SPC and a clear single click link to prescribing information and adverse event reporting provided on each frame.
The Panel did not consider, in the context of the four frames which made up the advertisement and in the particular circumstances of this case, that it was misleading or otherwise an unfair reflection to not have listed Forxiga’s side-effects on the advertisement at issue and thus ruled no breach of the Code.
The Panel noted its rulings of no breaches above and did not consider that AstraZeneca had failed to maintain high standards. No breach of the Code was ruled.
E Alleged failure to be clear as to what Forxiga was
The Panel noted that each of the four frames included a prominent logo which included the brand name, Forxiga, directly beneath which was the non-proprietary name, dapagliflozin. The Panel noted that the first frame of the banner advertisement started with the brand name, the non-proprietary name and the indication followed by a claim which also included the non-proprietary name in brackets. The claims on frames 2, 3 and 4 used only the brand name but nonetheless the non-proprietary name was included in the logo on each frame.
The Panel considered that the complainant had not shown, on the balance of probabilities, that the non-proprietary name was not clear in the advertisement and thus ruled no breach of the Code in this regard.
F Claim that Forxiga slows eGFR decline
With regard to the claim in the second frame, ‘FORXIGA slows eGFR decline and saves lives in CKD patients with T2D vs. placebo on top of standard of care’. The Panel noted that the final frame appeared to link to a page providing further information on the study, via clicking on through the button ‘Discover the data now’. The Panel did not consider that the complainant had shown that the alleged lack of context in relation to the trial population and the measured effect was, on the balance of probabilities, in breach of the Code and thus ruled no breach.
With regard to the allegation that it was not clear if the reference to CKD was related to previous banners or only T2D diabetes, the Panel noted that the claim ‘FORXIGA slows eGFR decline and saves lives in CKD patients with T2D vs. placebo on top of standard of care’ made reference to T2D within the claim itself. Further, in relation to the lack of reference that the DAPA-CKD trial excluded children and people without albuminuria, the Panel noted its comments under points B and C above. No breach of the Code was ruled. The Panel did not consider that AstraZeneca had failed to maintain high standards and ruled no breach of the Code.
G Overall consideration of Clause 2
The Panel, noting its rulings of no breach of the Code above, therefore ruled no breach of the Code."
AUTH/3623/3/22 - Complainant v Aimmune,"Promotion of Palforzia Peanut [defatted powder of Arachis hypogea L., semen (peanuts)] on LinkedIn",15-Mar-22,AUTH/3623/3/22,2021,24-Mar-23,2,"3.2, 3.4, 5.1, 5.6, 8.1, 12.1, 12.4, 12.6, 12.8, 12.9, 12.1, 16.1, 26.1",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3623322-complainant-v-aimmune/,"This case was in relation to a LinkedIn post on the Aimmune Therapeutics US LinkedIn account which was ‘liked’ by a current UK based employee.
The Panel ruled a breach of the following Clause(s) of the 2021 Code because the Aimmune UK employee’s engagement with the LinkedIn post had promoted Palforzia to health professionals and/or other relevant decision makers within his/her network without the provision of the obligatory information and to members of the public :
Breach of Clause 3.2
Advertising a prescription only medicine to the public
Breach of Clause 3.4
Failing to comply with all applicable codes, laws and regulations to which the company was subject
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 5.6
Failing to provide or make available material only to those groups of people whose need for, or interest in, it could reasonably be assumed and tailoring it to the audience to whom it was directed
Breach of Clause 8.1
Failing to certify promotional material
Breach of Clause 12.1
Failing to include up-to-date prescribing information
Breach of Clause 12.4
Failing to include up-to-date prescribing information in digital material
Breach of Clause 12.6
Failing to include a clear, prominent statement as to where prescribing information could be found
Breach of Clause 12.8
Failing to include the date on which the promotional material was created or revised
Breach of Clause 12.9
Failing to include information about how to report adverse events
Breach of Clause 12.10
Failing to include the black triangle when required
Breach of Clause 16.1
Promotional material directed to a UK audience failing to comply with all relevant requirements of the Code
Breach of Clause 26.1
Advertising a prescription only medicine to the public
The Panel ruled no breach of the following Clause(s) of the 2021 Code because it did not consider that the particular circumstances of this case warranted a breach ruling:
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry 
This summary is not intended to be read in isolation."
AUTH/3624/3/22 - Complainant v Pacira BioScience,Concerns about the promotion of Exparel,16-Mar-22,AUTH/3624/3/22,2021,23-Mar-23,"6.1, 6.4, 11.2, 14.1, 14.4, 17.9","5.1, 6.1, 6.2, 11.2, 14.4",Undertaking received,,Appeal by the respondent,https://www.pmcpa.org.uk/cases/completed-cases/auth3624322-complainant-v-pacira-bioscience/,"This case concerned claims for Exparel (liposomal bupivacaine) made within emails sent by a sales representative, working on behalf of Pacira BioScience, including: a claim that Exparel could be used as either infiltration or an adductor canal block; two claims for use of Exparel in total knee replacement as day surgery; four claims in relation to the efficacy of Exparel in lower limb arthroplasty; a claim stating that Exparel has an impact on ‘social and economic issues’; and an alleged failure to communicate the known risks of Exparel or link to prescribing information.
The Panel ruled breaches of the following Clause of the 2021 Code:
Breach of Clause 5.1
Failure to maintain high standards
Breach of Clause 6.1
Making misleading claims
Breach of Clause 6.2 
Making unsubstantiated claims
Breach of Clause 11.2 [One ruling successfully appealed]
Promotion inconsistent with the SPC
Breach of Clause 14.4
Making exaggerated claims
The Panel ruled no breaches of the following Clause of the 2021 Code:
No breach of Clause 6.1
Requirement that claims must not be misleading
No breach of Clause 6.4
Requirement that claims must reflect the available evidence regarding possible adverse reactions
No Breach of Clause 11.2
Requirement that promotion must not be inconsistent with the SPC
No breach of Clause 14.1
Requirement that misleading comparisons must not be made
No breach of Clause 14.4
Requirement that exaggerated or all-embracing claims must not be made.
No breach of Clause 17.9
Requirement that representatives’ briefing material must comply with the relevant requirements of the Code
APPEAL
Pacira BioSciences appealed one of the Panel’s rulings of a breach of Clause 11.2 of the 2021 Code in relation to a claim that Exparel could be used as either infiltration or as an adductor canal block which was overturned by the Appeal Board. The Appeal Board ruled no breach of the following Clause of the 2021 Code:
No Breach of Clause 11.2
Requirement that promotion must not be inconsistent with the SPC
This summary is not intended to be read in isolation"
AUTH/3625/3/22 - Complainant v Allergan,Alleged promotion of Botox on digital and social media channels,20-Mar-22,AUTH/3625/3/22,2021,12-Apr-23,"2, 8.1, 12.1, 12.3, 12.6, 12.9, 15, 16, 26.1, 26.2",,,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3625322-complainant-v-allergan/,"This case was in relation to Allergan allegedly using its medical device, Juvéderm (Hyaluronic Acid Filler), to promote its prescription only medicine, Botox.
The Panel ruled no breach of the following Clauses of the 2021 Code because it noted that if a reader followed the original link from the Juvéderm UK website, he/she was taken to the homepage of the global/US corporate website rather than a product page and a number of active clicks were required before Botox promotional information could be viewed. The Panel did not consider that the circumstances were such that Allergan UK had used its medical device to promote Botox across digital and social media channels as alleged including to the public and health professionals in the UK:
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry 
No Breach of Clause 8.1
Requirement to certify promotional material 
No Breach of Clause 12.1
Requirement to include up to date prescribing information 
No Breach of Clause 12.3
Requirement to include the non-proprietary name in promotional material 
No Breach of Clause 12.6
Requirement to include a prominent statement as to where the prescribing information can be found on promotional material on the internet
No Breach of Clause 12.9
Requirement to include a prominent adverse event statement on promotional materials
No Breach of Clause 15
Requirements for the high standard, format and suitability of promotional materials
No Breach of Clause 16
Requirements for the distribution of promotional materials
No Breach of Clause 26.1
Requirement not to advertise prescription only medicines to the public
No Breach of Clause 26.2
Requirement that information about prescription only medicines which is made available to the public must be factual, balanced, must not raise unfounded hopes of successful treatment or encourage the public to ask their health professional to prescribe a specific prescription only medicine.
This summary is not intended to be read in isolation."
AUTH/3626/3/22 - Complainant v Novartis,Promotion of Leqvio (inclisiran),31-Mar-22,AUTH/3626/3/22,2021,29-Mar-23,"2, 5.1, 8.1, 13.7, 15.5","5.1, 12.1",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3626322-complainant-v-novartis/,"This case was in relation to four articles that made up an online supplement titled ‘2021, Volume 28, Supplement 2: Inclisiran▼ – its clinical position in lipid management’ that was initiated and funded by Novartis which included the options to email and print it.
The Panel considered that the supplement constituted Leqvio promotional material for which Novartis would be responsible and ruled a breach of the following Clause of the 2021 Code as each of the four articles could be accessed without viewing the landing page which contained the black triangle and therefore should have included a black triangle as required by the Code and did not:
Breach of Clause 5.1
Requirement to maintain high standards
The Panel ruled no breach of the following Clauses of the 2021 Code in relation to the online supplement because it did not consider that the complainant had established that a non-promotional Novartis employee authoring a promotional article was inappropriate and had not provided evidence that any of the four articles had been shared as alleged. The complainant had raised the Clause which related to the inclusion of a black triangle in abbreviated advertisements and was thus not relevant to the articles within the supplement at issue. Each of the four articles had been certified by a medical signatory as part of the supplement under one job code and the possibility of the articles being emailed was included within the job bag when the supplement was certified and the Panel therefore considered that, in the circumstances, there was no evidence that the certification requirements in relation to emails had not been met. The Panel considered that whilst it was unacceptable to omit the black triangle within the each of the articles in question, it could, nonetheless, be viewed on the supplement landing page and on the prescribing information when accessed from the link within each of the four articles in question and, in the Panel’s view, the ruling of a breach of Clause 5.1 adequately covered this matter and an additional ruling of a breach of Clause 2 would be disproportionate in the particular circumstances of this case:
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 8.1
Requirement to certify promotional material
No Breach of Clause 13.7
Requirement to show an inverted black equilateral triangle when required by the licensing authority on abbreviated advertisements
No Breach of Clause 15.5
Requirement to obtain permission from the recipient of promotional digital communications
The Panel ruled a breach of the following Clauses of the 2021 Code in relation to the printed articles as it appeared from Novartis’ response that the printed articles would not have included prescribing information as required by the Code:
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 12.1
Failing to include up-to-date prescribing information
The Panel ruled no breach of the following Clauses of the 2021 Code in relation to the printed articles as there was no evidence that the certification requirements in relation to the printed articles had not been met and whilst the printed articles would not have included prescribing information, it was, nonetheless, available via a single-click link on every page of the online supplement and was therefore accessible to individuals printing the webpage:
No Breach of Clause 8.1
Requirement to certify promotional material
No breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
This summary is not intended to be read in isolation."
AUTH/3627/4/22 - Complainant v Daiichi Sankyo,Allegations about Lixiana patient information booklets,01-Apr-22,AUTH/3627/4/22,2021,14-Apr-23,6.4,"2, 5.1, 6.1, 6.2",Undertaking received,Advertisement,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3627422-complainant-v-daiichi-sankyo/,"This case was in relation to two booklets created by Daiichi Sankyo for patients prescribed Lixiana (edoxaban).
Whilst the front page of each booklet stated, ‘It’s important to read the Lixiana package leaflet provided with your medicine’, the Panel considered that it might not be clear to all patients that each 20 page booklet was not a substitute for the package leaflet or that the package leaflet contained additional important information on the use of the medicine that was not in the booklet.
The Panel ruled a breach of the following Clauses of the 2021 Code in relation to each booklet for the omission of safety information (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling) which, in the Panel’s view, might not be readily recognised as signs of excessive bleeding by the patient, and the misleading impression given that each booklet contained all the relevant information that the patient needed in relation to bleeding, which was incapable of substantiation and might prejudice patient safety:
Breach of Clause 2
Bringing discredit upon, and reducing confidence in, the Pharmaceutical industry
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 6.1
Providing misleading information
Breach of Clause 6.2
Misleading impression incapable of substantiation
The Panel ruled no breach of the following Clause of the 2021 Code in relation to each booklet as it did not consider that either booklet implied that the medicine had no side effects or no bleeding risk:
No Breach of Clause 6.4
Requirement that it must not be stated that a product has no adverse reactions
This summary is not intended to be read in isolation."
AUTH/3628/4/22 - Complainant v Novartis,Concerns about Novartis press releases,03-Apr-22,AUTH/3628/4/22,2021,14-Mar-23,"2, 5.1, 11.1, 12.1, 12.6, 12.9, 26.1, 26.2",,,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3628422-complainant-v-novartis//,"This case was in relation to six press releases available in the news section of Novartis’ UK website
Based on the complainant’s narrow allegation, the Panel ruled no breach of the following Clauses of the 2021 Code because:
it did not consider that the four preleases for licensed medicines hosted on the webpage in question were directed to, nor limited to, an audience of health professionals and other relevant decision makers and thus was not advertising to that audience as alleged and the allegations relating to the promotion to health professionals and associated requirements were not relevant
it did not consider that the four press releases for licensed medicines hosted on the webpage in question were directed to the general public and thus was not advertising to that audience as alleged
the complainant had not established that the two press releases related to pre-licensed medicines constituted promotion of medicines to health professionals prior to the grant of their marketing authorisation
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry 
No Breach of Clause 5.1
Requirement to maintain high standards 
No Breach of Clause 11.1
Requirement that a medicine must not be promoted prior to the grant of its marketing authorisation
No Breach of Clause 12.1
Requirement to include up to date prescribing information
No Breach of Clause 12.6
Requirement to include a prominent statement as to where the prescribing information can be found on promotional material on the internet
No Breach of Clause 12.9
Requirement that all promotional material must include the prominent adverse event statement
No Breach of Clause 26.1
Requirement not to advertise prescription only medicines to the public
No Breach of Clause 26.2
Requirement that information about prescription only medicines which is made available to the public must be factual, balanced, must not raise unfounded hopes of successful treatment or encourage the public to ask their health professional to prescribe a specific prescription only medicine. 
This summary is not intended to be read in isolation."
AUTH/3629/4/22 - Complainant v Daiichi Sankyo,Allegations about a disease awareness campaign on a patient organisation’s website,11-Apr-22,AUTH/3629/4/22,2021,30-Mar-23,"2, 5.1","5.2, 8.3",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3629422-complainant-v-daiichi-sankyo/,"This case was in relation to Daiichi Sankyo’s relationship with a patient organisation and the arrangements for a disease awareness programme.
The Panel ruled a breach of the following Clauses of the 2021 Code following its decision that the arrangement was a contract for services and Daiichi Sankyo was responsible for the material; certain educational material for the public related to this disease awareness campaign had not been certified as required by the Code:
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 8.3
Failing to certify educational material for the public related to disease
The Panel ruled no breach of the following Clauses of the 2021 Code as it had no evidence that the patient organisation had not included a declaration of Daiichi Sankyo’s involvement on all materials related to the campaign:
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry 
No Breach of Clause 5.5
Requirement to be sufficiently clear as to the company’s role and involvement 
This summary is not intended to be read in isolation."
AUTH/3630/4/22 - Ex-employee v Daiichi Sankyo,Mobile view of Daiichi Sankyo website promoting Lixiana,11-Apr-22,AUTH/3630/4/22,2021,15-Mar-23,"2, 12.1","5.1, 12.1, 12.4, 12.6, 12.9",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3630422-ex-employee-v-daiichi-sankyo/,"This case was in relation to the homepage of Daiichi Sankyo’s promotional Lixiana (edoxaban) mobile website which included the prescribing information and adverse event reporting statement within a collapsible menu bar.
The Panel ruled a breach of the following Clause(s) of the 2021 Code:
Breach of Clause 12.1
Not meeting the requirement for prescribing information to be positioned for ease of reference
Breach of Clause 12.4
Failing to provide prescribing information by way of a clear, and prominent, direct, single click link
Breach of Clause 12.6
Failing to include a clear prominent statement as to where the prescribing information can be found
Breach of Clause 12.9
Failing to include the adverse event reporting statement in a prominent manner
Breach of Clause 5.1
Failing to maintain high standards
The Panel ruled no breach of the following Clause(s) of the 2021 Code:
No Breach of Clause 12.1
The requirement, amongst other things, for prescribing information to be provided in a clear and legible manner
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
This summary is not intended to be read in isolation."
AUTH/3631/4/22 and AUTH/3636/4/22 - Complainant v AstraZeneca and Daiichi Sankyo,Concerns about a trastuzumab deruxtecan advisory board,11-Apr-22,AUTH/3631/4/22 AND AUTH/3636/4/22,2021,10-Mar-23,"2, 5.1, 19.1, 24.2",5.1,Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3631422-and-auth3636422-complainant-v-astrazeneca-and-daiichi-sankyo/,"This case was in relation to the nature of a trastuzumab deruxtecan advisory board entitled ‘T-DXd in the second-line setting in HER2+ mBC’.
The Panel ruled both AstraZeneca and Daiichi Sankyo in breach of the following Clause(s) of the 2021 Code due to insufficient details being provided to advisors about the advice being sought prior to them contractually agreeing to participate in the advisory board:
Breach of Clause 5.1
Failing to maintain high standards
The Panel ruled no breach of the following Clause(s) of the 2021 Code in relation to other allegations about the arrangements of the advisory board:
No Breach of Clause 24.2
The requirement that the arrangements for genuine consultancy services fulfil the criteria of this Clause, including a written contract in advance of the commencement of the services which specifies the nature of the services to be provided and the basis for payment of those services
No Breach of Clause 19.1
The requirement that no gift, pecuniary advantage or benefit may be supplied, offered or promised to health professionals or to other relevant decision makers in connection with the promotion of medicines or as an inducement to prescribe, supply, administer, recommend, buy or sell any medicine
No Breach of Clause 5.1
The requirement to maintain high standards
No Breach of Clause 2
The requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
This summary is not intended to be read in isolation."
AUTH/3632/4/22 - Complainant v Daiichi Sankyo,Allegations about a Lixiana webinar,11-Apr-22,AUTH/3632/4/22,2021,03-Apr-23,"2, 5.1, 6.1, 6.2, 8.1",,,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3632422-complainant-v-daiichi-sankyo/,"This case was in relation to a promotional video on how to initiate Lixiana (edoxaban) on a learned society’s website.
The Panel ruled no breach of the following Clauses of the 2021 Code because on the evidence available before it the material had not been made available to health professionals and was draft content, on what appeared to be an unlisted staging site:
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 6.1
Requirement that information must be accurate, up-to-date and not misleading
No Breach of Clause 6.2
Requirement that claims/information/comparisons must be capable of substantiation
No Breach of Clause 8.1
Requirement to certify promotional material
This summary is not intended to be read in isolation."
AUTH/3633/4/22 - Complainant v Novartis,Allegations misleading information for Entresto on a Novartis promotional website,13-Apr-22,AUTH/3633/4/22,,27-Apr-23,"6.1, 6.2","2, 5.1, 6.1",Undertaking received,Advertisement,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3633422-complainant-v-novartis/,"This case was in relation to allegations that the 'Starting and Monitoring Entresto' page of the Entresto (sacubitril/valsartan) promotional website contained misleading information and omitted important safety information.
The Panel ruled a breach of the following Clauses of the 2021 Code as it considered that
by providing some, but not all, the relevant information in relation to hepatic impairment and renal impairment in a section of the webpage which was intended to advise health professionals on considerations when using the medicine, was misleading:
Breach of Clause 6.1
Providing misleading information
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 2
Bringing discredit upon, and reducing confidence in the pharmaceutical industry
The Panel ruled no breach of the following Clauses of the 2021 Code on the basis that the complainant had not demonstrated that:
• health professionals would be misled by the claim ‘Monitoring and using Entresto is simple’ or that the claim, in the context of the particular webpage at issue, could not be substantiated;
• based on the very narrow allegation, the omission of liver function monitoring in the monitoring section of the webpage was misleading, noting the Entresto SPC did not specifically state that liver function should be monitored:
No Breach of Clause 6.1
Requirement that claims and information must not be misleading
No Breach of Clause 6.2
Requirement that claims must be capable of substantiation
This summary is not intended to be read in isolation."
AUTH/3634/4/22 - Complainant v Daiichi Sankyo,Allegations about an Edoxaban leavepiece,15-Apr-22,AUTH/3634/4/22,2021,03-Apr-23,"2, 6.1, 6.2, 9.1",,,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3634422-complainant-v-daiichi-sankyo/,"This case was in relation to a promotional leavepiece on how to initiate Lixiana (edoxaban).
Whilst the Panel had some concerns about the material, it ruled no breach of the following Clauses of the 2021 Code on the very narrow point that there was no evidence that it had been made available in any format to health professionals on or before the date of the complaint and the complainant had not established that relevant personnel had not been trained or were not conversant with the Code:
No Breach of Clause 6.1
Requirement that information must be accurate, up-to-date and not misleading
No Breach of Clause 6.2
Requirement that claims/information/comparisons must be capable of substantiation
No Breach of Clause 9.1
Requirement that all relevant personnel must be fully conversant with the Code
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
This summary is not intended to be read in isolation."
AUTH/3635/4/22 - Complainant v Novartis,Concerns about an Entresto podcast,18-Apr-22,AUTH/3635/4/22 - COMPLAINANT V NOVARTIS,2021,31-May-23,"2, 5.1, 6.1, 6.2, 6.5, 14.4","2, 5.1, 6.1, 6.2, 14.4",Undertaking received,Advertisement,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3635422-complainant-v-novartis/,"This case related to an Entresto podcast developed for heart failure specialist nurses (HFSN)
The Panel ruled breaches of the following Clauses of the 2021 Code on the basis that:
• a claim of an increase in energy in relation to the ability to get dressed was misleading as it was incapable of substantiation;
• use of ‘best’ was inextricably linked to the promotion of Entresto and implied that Entresto was the best in this context;
• reference to a ‘slight but acceptable drop in renal function’ without any qualification downplayed the importance of renal function and was misleading and incapable of substantiation and failure at the relevant point to qualify or provide further information about an important safety matter, was such that Novartis had reduced confidence in, and brought discredit upon, the industry in breach of Clause 2;
• the written briefing overall was not sufficiently clear and detailed such that the speaker would understand the relevant requirements of the Code and it considered that Novartis had failed to maintain high standards in that regard.
Breach of Clause 6.1
Requirement that claims/information must be accurate, up-to-date and not misleading
Breach of Clause 6.2
Requirement that claims must be capable of substantiation 
Breach of Clause 14.4
Requirement that claims should not imply that a medicine or an active ingredient has some special merit, quality or property unless this can be substantiated
Breach of Clause 5.1
Requirement to maintain high standards 
Breach of Clause 2
Requirement that material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry 
The Panel ruled no breach of the following Clauses of the 2021 Code on the basis that:
• ‘new’ was qualified in relation to the speaker’s experience at the time the product came to market and not when the podcast was made and it was not a claim that Entresto was ‘new’;
• it was reasonably clear that Entresto was being broadly compared to patients’ previous treatment options in heart failure and, therefore in the Panel’s view, the statement in question was not a hanging comparison;
• the complainant’s allegation, in relation to the claim ‘it improves their quality of life and life expectancy’, that none of the clinical trials had quality of life as an endpoint was incorrect;
• the complainant had not established his/her case in relation to substantiation that qualification of the status of trial endpoints in relation to two claims was required;
• it disagreed that the word ‘great’ was a superlative;
• the complainant had not established why differences in the parameters for initiation and monitoring meant that using Entresto was more complicated than ACE inhibitors or ARBs or his/her case as to the relevant differences between the monitoring requirements for patients on Entresto or ACE inhibitors;
• in the particular circumstances of this case, the briefing was adequately covered by the breach of Clause 5.1 ruling and an additional ruling of breach of Clause 2 would be disproportionate.
No Breach of Clause 6.1
Requirement that claims/information must be accurate, up-to-date, unambiguous and not misleading
No Breach of Clause 6.2
Requirement that claims must be capable of substantiation 
No Breach of Clause 6.5
Requirement that the word ‘new’ should not be used to describe any product which has been generally available for more than 12 months in the UK
No Breach of Clause 14.4
Requirement that claims should not imply that a medicine or an active ingredient has some special merit, quality or property unless this can be substantiated. 
No Breach of Clause 5.1
Requirement to maintain high standards 
No Breach of Clause 2
Requirement that material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry 
This summary is not intended to be read in isolation."
AUTH/3637/4/22 - Complainant v Daiichi Sankyo,Alleged promotion of Nilemdo and Nustendi to the public,23-Apr-22,AUTH/3637/4/22,2021,24-May-23,"2, 26.1, 26.2","5.1, 26.1, 26.2",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3637422-complainant-v-daiichi-sankyo//,"This case was in relation to Daiichi Sankyo’s myldltreatment website for patients who had been prescribed Nilemdo (bempedoic acid) or Nustendi (bempedoic acid, ezetimibe).
The Panel ruled a breach of the following Clauses of the 2021 Code as patients visiting the website who were prescribed Nilemdo (bempedoic acid) would be made aware of ezetimibe’s mechanism of action, as a selective cholesterol absorption inhibitor that prevents cholesterol from being absorbed in the gut, which would have likely encouraged patients prescribed Nilemdo to ask their health professional for Nustendi (bempedoic acid, ezetimibe). Furthermore, individuals on bempedoic acid and ezetimibe as separate tablets may have been encouraged to ask their health professional for the single tablet, Nustendi. Therefore, in the Panel’s view, the webpage promoted Nustendi to individuals prescribed Nilemdo and likely encouraged such individuals to ask their health professional to prescribe Nustendi:
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 26.1
Promoting a prescription only medicine to the public
Breach of Clause 26.2
Encouraging members of the public to ask for a specific prescription only medicine
The Panel ruled no breach of the following Clauses of the 2021 Code in relation to the alleged promotion of Nilemdo to individuals prescribed Nustendi, as the Panel noted that all patients visiting the webpage would have already been prescribed bempedoic acid. The Panel further ruled no breach as the complainant had not established that members of the public were exposed to product information due to a lack of disclaimer as alleged nor did the Panel consider that the matter was such that it brought discredit upon, or reduced confidence in, the industry:
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 26.1
Requirement not to promote prescription only medicines to the public
No Breach of Clause 26.2
Requirement that information about prescription only
medicines must not encourage the public to ask their health professional to prescribe a specific prescription only medicine.
This summary is not intended to be read in isolation."
AUTH/3638/4/22 - Complainant v Novartis,Promotional claims for Xolair on a Novartis website,24-Apr-22,AUTH/3638/4/22,2021,20-Apr-23,"2, 5.1, 6.1, 6.2, 11.2","5.1, 6.1, 6.2",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3638422-complainant-v-novartis//,"This case was in relation to the promotional messaging for Xolair on the Novartis-owned respiratory webpage for Severe Allergic Asthma (SAA) and dermatology webpage for Chronic Spontaneous Urticaria (CSU).
The Panel ruled a breach of the following Clauses of the 2021 Code in relation to use of the claim ‘Think Symptom Free’ in CSU on the Xolair dermatology webpage which misleadingly implied that Xolair would lead to all patients being symptom free and having achieved complete response, which was not so:
Breach of Clause 6.1
Making a misleading claim
Breach of Clause 6.2
Making an unsubstantiated claim
Breach of Clause 5.1
Failing to maintain high standards
The Panel ruled no breach of the following Clause of the 2021 Code in relation to use of the claim ‘Think Symptom Free’ in CSU on the Xolair dermatology webpage as it did not consider, noting it was a sign of particular censure, that it was warranted in the particular circumstances:
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
The Panel ruled no breach of the following Clauses of the 2021 Code in relation to use of the claim ‘Unlock Life*’ and qualification of the claim with a footnote on both the Xolair respiratory webpage for SAA and the Xolair dermatology webpage for CSU because in the Panel’s view in the circumstances the claim was capable of standing alone and on the evidence before it, it had not been established that the claim on each webpage was misleading or incapable of substantiation:
No Breach of Clause 6.1
Requirement that information must be accurate, up-to- date and not misleading
No Breach of Clause 6.2
Requirement that claims must be capable of substantiation
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
The Panel ruled no breach of the following Clauses of the 2021 Code in relation to the reference to severe asthma within the context of the Xolair respiratory webpage for SAA because it did not consider, on balance, that within the context of the webpage readers were given the impression that Xolair was for any patient with severe asthma, outside the terms of its licence:
No Breach of Clause 11.2
Requirement that a medicine must be promoted in accordance with the terms of its marketing authorisation and must not be inconsistent with the particulars listed in its summary of product characteristics
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
On the evidence before it, The Panel ruled no breach of the following Clause of the 2021 Code, in relation to the image of a jumping man on the Xolair respiratory webpage for SAA which allegedly implied severe asthma patients would be able to exert extra physical activity just by taking Xolair:
No Breach of Clause 5.1
Requirement to maintain high standards
The Panel ruled no breach of the following Clause of the 2021 Code overall as the complainant had not established that there was a lack of experience, understanding and integrity from Novartis around the importance of compliance and professional standards as alleged: 
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
This summary is not intended to be read in isolation."
AUTH/3639/4/22 - Complainant v Roche Products,Allegations about a Polivy promotional website,25-Apr-22,AUTH/3639/4/22,2021,24-Apr-23,"2, 5.1, 6.1, 6.2","2, 5.1, 6.1",Undertaking received,Advertisement,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3639422-complainant-v-roche-products/,"This case was in relation to allegations that the dosing page of the Polivy (polatuzumab vedotin) promotional website missed important administration instructions included in the Polivy summary of product characteristics (SPC) that were required to ensure patient safety.
The Panel ruled a breach of the following Clauses of the 2021 Code because the dosing webpage, which was intended to advise health professionals on the appropriate administration of the medicine, gave the misleading impression that it contained all the important information health professionals needed to administer Polivy, which was not so in respect of specific instructions about a particular infusion line and dose modifications in the event of an infusion related reaction:
Breach of Clause 6.1
Providing misleading information
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 2
Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
The Panel ruled no breach of the following Clauses of the 2021 Code on the basis that:
• health professionals were unlikely to be misled about the route of administration for Polivy (i.e. that it was to be administered as IV infusion and not IV bolus or push)
• there were no allegations that information was not capable of substantiation
• dose modifications information in relation to an infusion-related reaction was provided on the safety webpage:
No Breach of Clause 6.1
Requirement that information must not be misleading
No Breach of Clause 6.2
Requirement that information must be capable of substantiation
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
This summary is not intended to be read in isolation."
AUTH/3641/4/22 - Complainant v Teva,Concerns about DuoResp Spiromax website and when viewed on a mobile device,28-Apr-22,AUTH/3641/4/22,2021,23-Mar-23,"2, 5.1, 8.1, 26.2","5.1, 8.1, 12.6",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3641422-complainant-v-teva//,"This case was in relation to the DuoResp Spiromax (budesonide/formoterol) website particularly when viewed on a mobile device.
The Panel ruled a breach of the following Clauses of the 2021 Code because;
• the final form of the website differed for the mobile version compared to the desktop version and each should have been certified separately which had not occurred
• the presentation of a prescribing information link within a hamburger menu in relation to the three webpages did not meet the Code’s requirement for a clear prominent statement
• Teva had not adequately reviewed the website on mobile devices to ensure that it met the requirements of the Code when displayed on such devices:
Breach of Clause 8.1
Failure to certify promotional material
Breach of Clause 12.6
Failing to include a clear, prominent statement as to where prescribing information could be found
Breach of Clause 5.1
Failing to maintain high standards
The Panel ruled no breach of the following Clauses of the 2021 Code on the basis that the complainant had not established that;
• having the same job code on each page and section of the website meant that it had not been certified as required by the Code
• members of the public were encouraged by Teva to access information not appropriate for them as alleged
And although Teva did not spot that the prescribing information tab had become contracted into a hamburger menu, it had reviewed how the website would appear on a mobile device as part of the website certification and the prescribing information was available from the hamburger menu icon on the top right side and at the end of the webpage when accessed from a mobile phone, therefore in the particular circumstances of this case, the Panel did not consider that a ruling of a breach of Clause 2 was warranted in this regard:
No Breach of Clause 8.1
Requirement to certify promotional material
No Breach of Clause 26.2
Requirement that information about prescription only medicines which is made available to the public must be factual, balanced, must not raise unfounded hopes of successful treatment or encourage the public to ask their health professional to prescribe a specific prescription only medicine
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
This summary is not intended to be read in isolation."
AUTH/3640/5/22 - Voluntary admission by Novo Nordisk,GLP-1 receptor agonist supply issue email (UK22OZM00010),02-May-22,AUTH/3640/5/22,2021,21-Mar-23,,"5.1, 12.1, 12.8, 12.9",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3640522-voluntary-admission-by-novo-nordisk/,"This voluntary admission by Novo Nordisk was in relation to an email sent to health professionals to advise them that Novo Nordisk UK had no issues with the supply of the GLP-1 receptor agonists (GLP-1 RAs) Ozempic (semaglutide) and Rybelsus (semaglutide).
The Panel ruled a breach of the following Clause(s) of the 2021 Code as two representatives had each sent out the promotional email without all of the obligatory information being included:
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 12.1
Failing to include up-to-date prescribing information
Breach of Clause 12.8
Failing to include the date on which the promotional material was created or last revised
Breach of Clause 12.9
Failing to include information about how to report adverse events
This summary is not intended to be read in isolation."
AUTH/3642/5/22 - Complainant v Novartis,"Promotion of Entresto (sacubitril, valsartan)",05-May-22,AUTH/3642/5/22,2019,04-Apr-23,"2, 7.2, 9.1, 14.1",4.9,Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3642522-complainant-v-novartis//,"This case was in relation to concerns around the compliance culture at Novartis, particularly with regard to five Entresto promotional articles which were initiated and funded by Novartis Pharmaceuticals UK Ltd.
The Panel ruled a breach of the following Clause of the 2019 Code, as acknowledged by Novartis, in relation to each of the 5 articles, because whilst the adverse event reporting statement was included within the prescribing information, which was available via a link on each of the articles in question, it was not included within the body of the supplement or the articles themselves in line with the requirement of the Code:
Breach of Clause 4.9
Failing to include information about how to report adverse events
The Panel ruled no breach of the following Clauses of the 2019 Code as it did not consider that the complainant had established that:
• there was an error in the approval process
• the articles had not been certified
• the inclusion of the black triangle for Entresto on the 2019 articles, as they appeared on the BJC website, was inaccurate or misleading
• Novartis did not have a dedicated signatory team or that compliance at Novartis had been substandard
No Breach of Clause 7.2
Requirement that information must be accurate, up-to- date and not misleading
No Breach of Clause 9.1
Requirement to maintain high standards
No Breach of Clause 14.1
Requirement to certify promotional material
Although the Panel considered that it was unacceptable to omit the adverse event reporting statement within the articles in question, it could, nonetheless, be viewed on the prescribing information when accessed from the link within each of the five articles in question and thus the Panel did not consider, in relation to the allegations overall, that Novartis had failed to maintain high standards or that this case warranted a ruling of a breach of Clause 2 and it ruled no breach of the following Clauses of the 2019 Code:
No Breach of Clause 9.1
Requirement to maintain high standards
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
This summary is not intended to be read in isolation."
AUTH/3643/5/22 - Complainant v Novartis,Promotion of Kesimpta (ofatumumab),08-May-22,AUTH/3643/5/22,2021,24-May-23,"2, 5.1, 5.2, 6.3","5.1, 6.1, 6.2, 11.2, 12.1",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3643522-complainant-v-novartis/,"This case was in relation to a promotional webpage for Kesimpta on a Novartis Pharmaceuticals Limited website and a Kesimpta digital advertisement. 
Promotional webpage
The Panel ruled a breach of the following clauses of the 2021 Code because there was no indication, as part of the use of a Scottish Medicine Consortium (SMC) approval stamp or within its immediate visual field, that approval was restricted and the misleading implication of unrestricted approval by SMC could not be substantiated:
Breach of Clause 6.1
Making a misleading claim
Breach of Clause 6.2
Making an unsubstantiated claim
Breach of Clause 5.1
Failing to maintain high standards
The Panel ruled no breach of the following clauses of the 2021 Code on the basis that:
• it did not consider that the health professional audience would be misled by the image to consider that Kesimpta gave MS patients the ability to suddenly perform like a professional gymnast as alleged
• the material did not warrant particular censure
No Breach of Clause 5.2
Requirement that all material and activities must recognise the special nature of medicines and respect the professional standing or otherwise of the audience to which they are directed and must not be likely to cause offence
No Breach of Clause 6.3
Requirement that all artwork must conform to the letter and spirit of the Code
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
Digital advertisement
The Panel ruled a breach of the following clauses of the 2021 Code in relation to the:
• omission of ‘adult’ within the claim ‘Now licensed for relapsing forms of multiple sclerosis (RMS) with active disease’,
• failure to include the Northern Ireland (NI) prescribing information in material aimed at UK health professionals.
Breach of Clause 11.2
Promotion inconsistent with the Summary of Product Characteristics
Breach of Clause 12.1
Failing to include up-to-date prescribing information
Breach of Clause 5.1
Failing to maintain high standards
The Panel ruled no breach of the following clause of the 2021 Code on the basis that in the particular circumstances of this case, the GB prescribing information was included and the only difference between the available GB prescribing information and the omitted NI prescribing information was the MA number and therefore its rulings of a breach of Clause 5.1 in relation to the digital advertisement adequately covered these matters and an additional ruling of a breach of Clause 2 would be disproportionate:
No Breach of Clause 2
Requirement that material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
This summary is not intended to be read in isolation."
AUTH/3644/5/22 and AUTH/3694/10/22 - Complainant v Croma Pharma,Excessive hospitality in relation to a Letybo launch symposium,10-May-22,AUTH/3644/5/22 AND AUTH/3694/10/22,2021,08-Jun-23,,"2, 5.1, 10.1",Undertaking received,Advertisement,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3644522-and-auth36941022-complainant-v-croma-pharma/,"This case was in relation to a Croma Pharma Letybo (botulinum toxin type A) launch symposium held in Monaco. 
The Panel ruled the following breaches of the 2021 Code because it considered that the impression created by the arrangements of the symposium was such that hospitality, including the venue, did not appear to be secondary to the main purpose of the event, and this was compounded by the poor impression created by the signage: 
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 10.1
Providing inappropriate hospitality
For the poor impression created by the arrangements, noting that hospitality provided, in particular at international meetings, attracted public scrutiny and noting that the relevant supplementary information included matters of excessive hospitality, Croma Pharma was, on balance, ruled in breach of the following Clause of the 2021 Code: 
Breach of Clause 2
Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
This summary is not intended to be read in isolation."
AUTH/3645/5/22 - Complainant v Proveca,Concerns about the dosing calculator app for Sialanar (glycopyrronium bromide),12-May-22,AUTH/3645/5/22,2021,29-Jun-23,"2, 5.1, 12.3, 26.1, 26.2","5.1, 8.1, 11.2, 12.1, 12.3, 12.6, 12.9",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3645522-complainant-v-proveca/,"This case was in relation to the Sialanar dosage application, which was accessible from a promotional webpage of the proveca.com website.
The Panel ruled a breach of the following Clauses of the 2021 Code because:
• the non-proprietary name did not appear immediately adjacent to the first appearance of the brand name Sialanar on the landing page of the dosing calculator app
• the dosing calculator app did not include prescribing information or a clear prominent statement as to where it could be found
• although adverse event reporting information was included in the dosing calculator app, the wording, as stipulated in Clause 12.9 of the Code, was not included: 
Breach of Clause 12.1
Failing to include up-to-date prescribing information
Breach of Clause 12.3
Failing to include the non-proprietary name of the medicine immediately adjacent to the most prominent display of the brand name
Breach of Clause 12.6
Failing to include a clear, prominent statement as to where prescribing information could be found
Breach of Clause 12.9
Failing to include the prominent adverse event reporting statement
The Panel ruled a breach of the following Clauses of the 2021 Code for:
• referring to Sialanar dosing in children, which might imply that Sialanar was licensed in all children which was not so; it was only licensed from 3 years
• not certifying the dosage application as a standalone item 
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 8.1
Failing to certify promotional material
Breach of Clause 11.2
Promotion inconsistent with the Summary of Product Characteristics
The Panel ruled no breach of the following Clause of the 2021 Code because:
• in the particular circumstances of this case the Panel considered that the rulings of a breach of the Code above were sufficient and an additional ruling of a breach of Clause 2 was not warranted:
No Breach of Clause 2
Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
The Panel ruled no breach of the following Clause of the 2021 Code because: 
• it considered the app to be one piece of promotional material/item and that ‘Sialanar’ on the landing page was the first mention within the material and therefore, the subsequent mentions, including on the dosage calculator page, the ‘User Guide’ page, and the ‘Adverse Events’ page, noting that it appeared that it could not be accessed without first accessing the landing page, would not require inclusion of the non-proprietary name
No Breach of Clause 12.3
Requirement to include the non-proprietary name in electronic promotional material immediately adjacent to the brand name at its first appearance
The Panel ruled no breach of the following Clauses of the 2021 Code because:
• based on the complainant’s narrow allegation, it did not consider that the complainant had established that the dosing calculator app was accessible by patients without a separate area for them
No Breach of Clause 2
Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 26.1
Requirement not to advertise prescription only medicines to the public
No Breach of Clause 26.2
Requirement that information about prescription only medicines which is made available to the public must not encourage the public to ask their health professional to prescribe a specific prescription only medicine
This summary is not intended to be read in isolation."
AUTH/3646/5/22 - Complainant v Roche,Concerns about dosing considerations website for Rozlytrek,12-May-22,AUTH/3646/5/22,2021,23-May-23,"6.1, 6.2","2, 5.1, 6.1",Undertaking received,Advertisement,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3646522-complainant-v-roche/,"This case was in relation to the dosing webpage of the Rozlytrek (entrectinib) promotional website which missed important information about dose modifications included in the Rozlytrek summary of product characteristics (SPC) that were required to ensure appropriate prescribing and patient safety.
The Panel ruled a breach of the following Clauses of the 2021 Code because the dosing webpage, which was intended to advise health professionals on the appropriate
administration of the medicine, gave the misleading impression that it contained all the important information health professionals needed to prescribe Rozlytrek in patients with congestive heart failure or QT interval prolongation, elevated ALT and AST, central nervous system adverse reactions, and hyperuricaemia, anaemia or neutropenia which was not so. Noting that Rozlytrek was a black triangle medicinal product subject to additional monitoring, and that important safety information was omitted from the dosing webpage, the Panel considered that Roche had failed to maintain high standards and had brought discredit upon and reduced confidence in the pharmaceutical industry.
Breach of Clause 6.1
Providing misleading information
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 2
Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
The Panel ruled no breach of the following Clauses of the 2021 Code on the basis that there were no allegations that the information was not capable of substantiation and the complainant had not established that the webpage gave misleading information regarding fractures or that the information regarding fractures was not substantiated.
No Breach of Clause 6.1
Requirement that information must not be misleading
No Breach of Clause 6.2
Requirement that information must be capable of substantiation
This summary is not intended to be read in isolation."
AUTH/3647/5/22 - Voluntary admission by Leo,Uncertified promotional material,13-May-22,AUTH/3647/5/22,2019,04-May-23,2,"9.1, 14.1",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3647522-voluntary-admission-by-leo/,"This was a voluntary admission by Leo in relation to the ‘At a glance’ and ‘Mode of action’ webpages of the Kyntheum (brodalumab) promotional website. The matter had come to Leo’s attention following its investigation in relation to Case AUTH/3503/4/21.
The Panel ruled a breach of the following Clause of the 2019 Code, in relation to each webpage, as material published on the ‘At a glance’ webpage differed to that which was certified, and material approved for the global website had in error been uploaded to the UK website for the ‘Mode of action’ webpage:
Breach of Clause 14.1
Failing to certify promotional material as required by the Code
The Panel ruled a breach of the following Clause of the 2019 Code as, in its view, the certification process underpinned self-regulation and the Panel was concerned that Leo did not have adequate control over its promotional materials:
Breach of Clause 9.1
Failing to maintain high standards
The Panel ruled no breach of the following Clause of the 2019 Code as allegations about the content of the webpages at issue were addressed in the previous case (Case AUTH/3503/4/21), and the Panel considered that the matter in relation to uncertified promotional material in this voluntary admission (Case AUTH/3647/5/22) was adequately covered by its rulings above:
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry 
This summary is not intended to be read in isolation."
AUTH/3648/5/22 - Complainant v Novartis,"Promotion of Entresto (sacubutril,valsartan)",15-May-22,AUTH/3648/5/22,2019,30-May-23,"2, 3.2, 12.1","4.1, 4.3, 4.6, 4.9, 9.1",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3648522-complainant-v-novartis/,"This case was in relation to allegations about a virtual meeting and a write up of the meeting, which the complainant alleged constituted disguised promotion of Entresto.
The Panel ruled a breach of the following Clause of the 2019 Code as Novartis’ classified the meeting as non-promotional, noting the mention of Novartis’ medicine on several slides by brand name (Entresto), non-proprietary name (sacubitril valsartan) and drug class (ARNI) and the strong, emotive messaging ‘Don’t let our heart failure patients die on suboptimal therapy’ following discussions of treatment options which included Entresto: 
Breach of Clause 9.1
Failing to maintain high standards
The Panel ruled no breach of the following Clauses of the 2019 Code as, in its view, health professionals, on the balance of probabilities, would be likely to assume that the meeting would include material on Novartis’ medicines and therefore be promotional and it had not been established that the promotion of Entresto during the virtual meeting was not in accordance with the terms of its marketing authorisation:
No Breach of Clause 12.1
Requirement that promotional material and activities must not be disguised
No Breach of Clause 3.2
Requirement to not promote a medicine for an unlicensed indication
With regard to the meeting write up, the Panel considered that the material was promotional and ruled a breach of the following Clauses of the 2019 Code for failing to include the obligatory information: 
Breach of Clause 4.1
Failing to include up-to-date prescribing information
Breach of Clause 4.3
Failure to include non-proprietary name of the medicine immediately adjacent to the most prominent display of the brand name
Breach of Clause 4.6
Failing to include a clear, prominent statement as to where prescribing information could be found
Breach of Clause 4.9
Failing to include information about how to report adverse events
Breach of Clause 9.1
Failing to maintain high standards
The Panel ruled no breach of the following Clause of the 2019 Code in relation to the meeting write up:
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
This summary is not intended to be read in isolation."
AUTH/3654/5/22 - Health professional v Novartis,Allegations about an Entresto (sacubitril/valsartan) promotional video on alearned society’s website,23-May-22,AUTH/3654/5/22,2021,25-May-23,"2, 5.1, 6.1, 8.1","5.1, 6.1, 12.1",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3654522-health-professional-v-novartis/,"This case was in relation to a Novartis promotional symposium video hosted on a learned society’s website following its conference in September 2021.
The Panel ruled a breach of the following Clauses of the 2021 Code for failing to state that Entresto should not be initiated in patients with SBP [systolic blood pressure] < 100 mmHg or serum potassium level >5.4 mmol/l and for failing to include Entresto prescribing information within the video:
Breach of Clause 6.1
Misleading material that was not sufficiently complete to enable viewers to form their own opinion of the therapeutic value of the medicine
Breach of Clause 12.1
Failing to include prescribing information
Breach of Clause 5.1
Failing to maintain high standards
The Panel ruled no breach of the following Clauses of the 2021 Code as:
• The video had been certified.
• The complainant had made a very narrow allegation with regard to checking hepatic function as per the SPC, however, Novartis submitted that monitoring of liver function was not a specific requirement of Entresto.
• There was no allegation that information in the video was not capable of substantiation.
• The Panel considered that the matter in relation to the omission of prescribing information was covered by its ruling of breaches of Clauses 12.1 and 5.1 and an additional ruling of a breach of Clause 2 was not required.
• Whilst concerned about the editing of the video, overall, the Panel considered that health professionals would likely be left with the impression that there were important clinical considerations with the use of Entresto, including in relation to potassium and blood pressure, prompting them to refer to more detailed information such as the SPC prior to use of Entresto; on balance, the Panel did not consider that the video meant that Novartis had reduced confidence in, or brought discredit upon, the industry.
No Breach of Clause 6.1
Requirement that information must not be misleading 
No Breach of Clause 6.2
Requirement that information must be capable of substantiation 
No Breach of Clause 8.1
Requirement to certify promotional material 
No Breach of Clause 5.1
Requirement to maintain high standards 
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry 
This summary is not intended to be read in isolation."
AUTH/3652/5/22 - Complainant v Merck Sharp & Dohme,Disguised promotion of chicken pox vaccine,24-May-22,AUTH/3652/5/22,2021,12-Jun-23,"3.6, 5.1",,,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3652522-complainant-v-merck-sharp-dohme/,"This case was in relation to an allegation that there was disguised promotion of Merck Sharp & Dohme’s chicken pox vaccine in the London Politico Playbook and on the accompanying website.
Based on the complainant’s narrow allegation, the Panel ruled no breach of the following Clauses of the 2021 Code because it did not consider that the complainant had established that the specific issue of the London Playbook or the associated Stop the Spots website promoted a prescription only medicine and therefore each could not constitute disguised promotion as alleged:
No Breach of Clause 3.6
Requirement that materials and activities must not be disguised promotion
No Breach of Clause 5.1
Requirement to maintain high standards 
This summary is not intended to be read in isolation."
AUTH/3650/5/22 - Eli Lilly v UCB,Bimzelx leavepiece,27-May-22,AUTH/3650/5/22,2021,22-Aug-23,,"5.1, 6.1, 6.2",Undertaking received,,Appeal by respondent,https://www.pmcpa.org.uk/cases/completed-cases/auth3650522-eli-lilly-v-ucb/,"This case was in relation to three claims within a Bimzelx (bimekizumab) leavepiece issued by UCB Pharma Ltd which Eli Lilly alleged were unfair, unbalanced and misleading and could not be substantiated. The Panel ruled a breach of the following Clauses of the 2021 Code because it considered that within the context of the leavepiece:
• the extrapolation of in vitro data to clinical significance implied by the claim ‘Blocking IL-17A and IL-17F results in superior inhibition of inflammatory responses vs blocking IL-17A alone’ was misleading and the implication of clinical superiority of IL-17A and IL-17F blockade over IL-17A alone had not been substantiated
• the clinical relevance and significance implied by the claim ‘BIMZELX provides more complete inhibition of the IL-17A and IL-17F pathway compared with blocking IL-17A alone’ was misleading; the extrapolation of such in vitro data to the clinical situation should only be made where there was data to show that it was of direct relevance and significance
• the claim ‘IL-17F levels are approximately 30-fold higher than IL-17A in psoriatic skin’, misled as to the clinical significance of the relative concentrations of IL-17 protein levels as evidenced in the in-vitro data 
Breach of Clause 5.1 (unsuccessfully appealed)
Failing to maintain high standards
Breach of Clause 6.1 (unsuccessfully appealed)
Making a misleading claim 
Breach of Clause 6.2 (unsuccessfully appealed)
Making an unsubstantiated claim
APPEAL
All the Panel’s rulings of breaches of the 2021 Code were upheld on appeal by UCB.
This summary is not intended to be read in isolation."
AUTH/3651/5/22 - Complainant v Roche,Allegations about an Ocrevus website,30-May-22,AUTH/3651/5/22,2021,23-May-23,"2, 5.1, 6.1, 6.2",,,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3651522-complainant-v-roche/,"This case related to allegations that the claim ‘generally well tolerated’ used on the landing page of the Ocrevus (ocrelizumab) website was misleading, not balanced or accurate in view of clinical trial findings of serious adverse events.
The Panel ruled no breach of the following Clauses of the 2021 Code on the basis that the claim was qualified by a list of linked aspects of the safety and tolerability profile within the immediate visual field of the claim in question which were designed to catch the reader’s eye such that it would be sufficiently clear that the claim was not unqualified and therefore not misleading or incapable of substantiation:
No Breach of Clause 2
Requirement that material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 6.1
Requirement that claims must not be misleading
No Breach of Clause 6.2
Requirement that claims must be capable of substantiation
This summary is not intended to be read in isolation."
AUTH/3653/5/22 - Eli Lilly v Novo Nordisk,Novo Nordisk position statement regarding supplies of certain Lilly medicines for diabetes,31-May-22,AUTH/3653/5/22,2021,05-Apr-23,"2, 5.1",6.6,Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3653522-eli-lilly-v-novo-nordisk//,"This case was in relation to promotional emails sent by Novo Nordisk Ltd to health professionals regarding the available supply of GLP-1 Receptor Agonists (GLP-1RAs).
The Panel ruled a breach of the following Clause of the 2021 Code as it considered that including the statement ‘Novo Nordisk’s priority is maintaining supply of treatment to support adults living with type 2 diabetes’ followed by ‘We can reassure you as an HCP, that we have supply available of all doses of both Ozempic® ▼ (once-weekly semaglutide) and RYBELSUS® ▼ (semaglutide tablets), should you be seeking a GLP-1 RA to prescribe for adults with type 2 diabetes at this time’ directly below reference to Eli Lilly having supply issues was such that it implied that maintaining supply of treatment was not a priority for Eli Lilly and thus was disparaging towards Eli Lilly:
Breach of Clause 6.6
Disparaging another company
The Panel ruled no breach of the following Clauses of the 2021 Code based on the complainant’s allegations because it did not consider that the emails misled the reader regarding the content of the referenced email from the Department of Health and Social Care (DHSC) to Novo Nordisk in relation to the timeframe of the stock outage of Lilly’s product or misrepresented the DHSC’s intentions by not making clear that switching to a Novo Nordisk GLP-1 RA was not the preferred option, nor did the Panel consider that the emails were in conflict with DHSC guidance with regards to when switching to an alternative GLP‐1 RA should be considered, nor that referring to Rybelsus and not Bydureon and Victoza or continuing to reference a DHSC email rather than the official DHSC Medicine Supply Notification (MSN) was inappropriate and misleading as alleged:
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 5.1
Requirement to maintain high standards
This summary is not intended to be read in isolation."
AUTH/3655/6/22 - Anonymous Health Professional v Novartis,Alleged promotion of Mayzent,06-Jun-22,AUTH/3655/6/22,2021,27-Jun-23,"2, 5.1, 6.1, 6.2","2, 5.1, 6.1, 6.2",Undertaking received,Advertisement,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3655622-anonymous-health-professional-v-novartis/,"This case was in relation to the promotion of Mayzent (siponimod) on the ‘Dosing and administration’ page on a Novartis website. 
The Panel ruled a breach of the following Clauses of the 2021 Code for referring to Mayzent initiation in patients with a history of myocardial infarction and heart failure without making apparent the absolute contra-indication in patients with a history of myocardial infarction or heart failure in the previous 6 months, except on a separate webpage and within the prescribing information which, in the Panel’s view, was insufficient to negate this immediate misleading impression: 
Breach of Clause 6.1
Providing misleading information
Breach of Clause 6.2
Providing a misleading impression which was incapable of substantiation
Breach of Clause 5.1
Failure to maintain high standards
Breach of Clause 2
Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
The Panel ruled no breach of the following Clauses of the 2021 Code as it did not consider that highlighting the contraindication in pregnancy for Mayzent meant that health professionals would assume there would be no other considerations or contraindications:
No Breach of Clause 6.1
Requirement that claims must not be misleading
No Breach of Clause 6.2
Requirement that claims must be capable of substantiation
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
This summary is not intended to be read in isolation."
AUTH/3658/6/22 - Complainant v Novartis,Allegations about an email regarding a promotional symposium for Mayzent(siponimod),13-Jun-22,AUTH/3658/6/22,2021,19-Jun-23,"2, 5.1, 8.1, 11.2",,,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3658622-complainant-v-novartis/,"This case was in relation to an email distributed by a multiple sclerosis independent education provider about a Novartis promotional symposium.
The Panel ruled no breach of the following Clauses of the 2021 Code as:
• the email had been certified
• the complainant had not established that reference to ‘Mayzent for SPMS with Active Disease’, within the particular material at issue, promoted Mayzent in a manner that was inconsistent with its SPC or was unqualified as alleged
• the complainant had not established that the material had not made clear that the webinar was only for health professionals.
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 8.1
Requirement to certify promotional material
No Breach of Clause 11.2
Requirement not to promote a medicine in a manner that was inconsistent with its SPC
This summary is not intended to be read in isolation."
AUTH/3659/6/22 - Complainant v Teva,Allegations about the promotion of Ajovy on a Teva website,15-Jun-22,AUTH/3659/6/22,2021,19-Jun-23,"2, 3.6, 5.1, 6.1, 6.2, 11.2, 26.2","5.1, 12.6, 12.1, 16.1",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3659622-complainant-v-teva/,"This case was in relation to a Teva registration website for health professionals to register for access to recorded webinar highlights videos from a meeting in relation to Ajovy (fremanezumab).
The Panel ruled a breach of the following Clauses of the 2021 Code for having a link to the prescribing information that was not sufficiently prominent thereby failing to maintain high standards, and failing to include the black triangle adjacent to the first mention of Ajovy on two separate pages of the website.
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 12.6
Failing to include a clear, prominent statement as to where prescribing information could be found
Breach of Clause 12.10
Failing to include a black triangle adjacent to the first mention of the product in digital material
Breach of Clause 16.1
Producing a website that contained promotional material which did not comply with all relevant requirements of the Code
The Panel ruled no breach of the following Clauses of the 2021 Code on the basis that in the particular circumstances of this case, the landing page had not disguised the promotional nature of the registration website homepage and the complainant had not established that:
• the claim ‘Less migraine. More moments’ was a hanging comparison and had not made out their allegation that it was incapable of substantiation
• the homepage and contents page of the website promoted Ajovy outside the licensed indication, and
• in the particular circumstances of this case the absence of an option for members of the public on the landing page meant that members of the public had accessed information not intended for them
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 3.6
Requirement that materials and activities must not be disguised promotion
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 6.1
Requirement that claims must not be misleading
No Breach of Clause 6.2
Requirement that claims must be capable of substantiation
No Breach of Clause 11.2
Requirement that a medicine must be promoted in accordance with the terms of its marketing authorisation and must not be inconsistent with the particulars listed in its summary of product characteristics
No Breach of Clause 26.2
Requirement that information about prescription only medicines which is made available to the public must be factual, balanced, must not raise unfounded hopes of successful treatment or encourage the public to ask their health professional to prescribe a specific prescription only medicine.
This summary is not intended to be read in isolation."
AUTH/3661/6/22 - Complainant v AstraZeneca,Concerns about certification of the Forxiga website and an alleged breach of undertaking,17-Jun-22,AUTH/3661/6/22,2021,02-Jun-23,"2, 3.3, 5.1",8.1,Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3661622-complainant-v-astrazeneca/,"This case was in relation to the alleged failure to separately certify mobile phone and desktop versions of the Forxiga website and an alleged breach of undertaking.
The Panel ruled a breach of the following Clause of the 2021 Code on the basis that the final form differed between the desktop and mobile versions of the website due to the inclusion of a prominent statement about the intended audience at the top of the desktop webpage but not at the top of the mobile version: 
Breach of Clause 8.1
Failure to meet the requirements for certifying material
The Panel ruled no breach of the following Clauses of the 2021 Code in relation to high standards and the failure to separately certify the desktop and mobile webpage and in relation to an alleged breach of undertaking.
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 3.3
Requirement to comply with an undertaking
No Breach of Clause 5.1
Requirement to maintain high standards
This summary is not intended to be read in isolation."
AUTH/3663/6/22 - Complainant v Roche,Allegations about the promotion of Ocrevus on the Roche resources website,19-Jun-22,AUTH/3663/6/22,2021,14-Jun-23,"2, 3.2, 5.1, 11.2",,,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3663622-complainant-v-roche/,"This case was in relation to allegations that Ocrevus (ocrelizumab) had been promoted for unlicensed indications on the congress and meetings landing page on the Roche resources website.
The Panel ruled no breach of the following Clauses of the 2021 Code, as it did not consider that the complainant had established that:
• the congress and meetings landing page advertised prescription only medicines to the public,
• reference to COVID-19 in a meeting title ‘COVID-19 in Ocrevus-treated patients – the story so far’ was misleading or implied that Ocrevus was indicated for COVID-19, and
• the inclusion of a link to the Ocrevus prescribing information on the webpage, in itself, would imply to a health professional that the medicine was licensed for all the conditions and therapeutic areas mentioned within the congress/meeting tiles on that page.
No Breach of Clause 2
Requirement that material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 3.2
Requirement not to advertise prescription only medicines to the public
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 11.2
Requirement not to promote a medicine for an unlicensed indication
This summary is not intended to be read in isolation."
AUTH/3664/6/22 - Complainant/Director v AstraZeneca,Promotional email for Symbicort Turbohaler and alleged breach of undertaking,21-Jun-22,AUTH/3664/6/22,2021,08-Jun-23,"2, 3.3, 5.1","5.1, 12.3",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3664622-complainantdirector-v-astrazeneca/,"This case was in relation to an email with the subject line, ‘AstraZeneca promotional email: Symbicort Turbohaler – Device matters when prescribing MART’ and an alleged breach of the undertaking given in Case AUTH/1800/2/06.
The Panel ruled a breach of the following Clauses of the 2021 Code as the non-proprietary name was not present immediately adjacent to the brand name at its first appearance in the email and the Panel was concerned about the arrangements for the certification of the email in question:
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 12.3
For electronic advertisements, the non-proprietary name of the medicine must appear immediately adjacent to the brand name at its first appearance
The Panel ruled no breach of the following Clauses of the 2021 Code in relation to the alleged breach of undertaking given in Case AUTH/1800/2/06 as the Panel considered that it was sufficiently different to this current case, including that it related to the actions of a representative:
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry 
No Breach of Clause 3.3
Requirement to comply with an undertaking 
No Breach of Clause 5.1
Requirement to maintain high standards 
This summary is not intended to be read in isolation."
AUTH/3665/6/22 - Complainant v Novartis,Concerns about misleading claims about Entresto on a Novartis website,24-Jun-22,AUTH/3665/6/22,2021,01-Aug-23,"2, 5.1, 6.2, 6.1","5.1, 6.1",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3665622-complainant-v-novartis/,"The Panel ruled a breach of the following Clauses of the 2021 Code in relation to the claim ‘National guidelines support ENTRESTO as a 1st line treatment option in chronic HFrEF’ not being sufficiently complete, as in the Panel’s view, the broad target audience, which included ‘Physician; Pharmacist; Payor / Health Insurance / Nurse / Other Healthcare Stakeholder’ according to the certificate, was unlikely to all be aware that the definition of HFrEF was less than 40% LVEF: 
Breach of Clause 6.1
Requirement that material must be sufficiently complete to enable recipients to form their own opinion of the therapeutic value of the medicine
Breach of Clause 5.1
Failure to maintain high standards
The Panel ruled no breach of the following Clauses of the 2021 Code in relation to the claim ‘National guidelines support ENTRESTO as a 1st line treatment option in chronic HFrEF’ as the complainant had not provided reasons or evidence and thereby established that the claim was incapable of substantiation, and because Clause 2 was a sign of particular censure which was not warranted in the particular circumstances of this case: 
No Breach of Clause 6.2
Requirement that claims must be capable of substantiation
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
The Panel ruled no breach of the following Clause of the 2021 Code in relation to the claim ‘Starting ENTRESTO can lead to substantial improvements in social and physical activities comparable to feeling 9 YEARS YOUNGER vs ACEi (enalapril)*’ as the Panel did not consider that the use of the asterisk which stated that the claim was based on a secondary analysis of a study meant that the claim in question hid that it was not based on primary endpoint data: 
No breach of Clause 6.1
Requirement that claims must not be misleading
The Panel ruled no breach of the following Clauses of the 2021 Code for each of the following claims: ‘Improve the chronic HFrEF patient’s experience vs ACEi (enalapril) ‐ improvements in quality of life’, ‘Patients on ENTRESTO feel better, stay out of the hospital, and live longer vs ACEi (enalapril)’, ‘Starting ENTRESTO can lead to substantial improvements in social and physical activities comparable to feeling 9 YEARS YOUNGER vs ACEi (enalapril)*’(Clause 6.1 covered above), as in relation to each allegation the complainant was unable to establish their case:
No Breach of Clause 6.1
Requirement that claims must not be misleading
No Breach of Clause 6.2
Requirement that claims must be capable of substantiation
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
This summary is not intended to be read in isolation."
AUTH/3667/6/22 - Health professional v Roche,Certification of the mobile version of a webpage and alleged off-licence promotion,26-Jun-22,AUTH/3667/6/22,2021,14-Jun-23,"2, 5.1, 8.1, 11.2",,,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3667622-health-professional-v-roche/,"This case was in relation to the mobile version of a webpage on the Roche resources website, within the congress and meetings section, which allegedly required separate certification and allegedly promoted Kadcyla (trastuzumab emtansine) and Perjeta (pertuzumab) outside of their marketing authorisations.
The Panel ruled no breach of the following Clauses of the 2021 Code as it did not consider that the complainant had established that the difference in final form between the desktop and mobile versions meant that the two versions should have been certified separately nor did it consider that, within the context of the webpage, the title of a video, ‘Tailoring Treatment for Patients with HER-2 positive Early Breast Cancer’, which was a virtual meeting, implied that Kadcyla and Perjeta were licensed for use in all patients with HER-2 positive early breast cancer as alleged.
No Breach of Clause 2
Requirement that material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 8.1
Requirement to certify promotional material
No Breach of Clause 11.2
Requirement not to promote a medicine for an unlicensed indication
This summary is not intended to be read in isolation."
AUTH/3666/6/22 - Complainant v Daiichi Sankyo,Concerns about an article published in the Health Service Journal (HSJ),27-Jun-22,AUTH/3666/6/22,2019,02-Jun-23,"2, 9.1, 12.1, 14.1","9.1, 9.1",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3666622-complainant-v-daiichi-sankyo/,"This case was in relation to the alleged disguised promotion by Daiichi Sankyo UK Limited in the Health Service Journal (HSJ).
The Panel ruled a breach of the following Clauses of the 2019 Code as the fact the author was a senior employee of Daiichi-Sankyo should have appeared at the top of the article so that readers were aware of the extent of the company’s involvement from the outset:
Breach of Clause 9.10
Failing to be sufficiently clear as to the company’s role and involvement
Breach of Clause 9.1
Failing to maintain high standards
The Panel ruled no breach of the following Clauses of the 2019 Code because it did not consider that the complainant had established that:
• the article promoted a specific Daiichi Sankyo medicine
• Daiichi Sankyo’s compliance understanding, framework and application were severely poor as seen by the raft of breaches on a regular basis or that the compliance knowledge had serious gaps or that the compliance responsibilities and accountabilities were not improving as alleged
No Breach of Clause 12.1
Requirement that promotional material and activities must not be disguised
No Breach of Clause 14.1
Requirement to certify promotional material
No Breach of Clause 9.1
Requirement to maintain high standards
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry 
This summary is not intended to be read in isolation."
AUTH/3668/6/22 - Complainant v Galapagos,,29-Jun-22,AUTH/3668/6/22,2021,03-Jul-23,"6.1, 6.2, 14.4",6.1,Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3668622-complainant-v-galapagos/,"This case was in relation to claims made on Galapagos UK’s website (strengthofbalance.co.uk) for its product Jyseleca (filgotinib). 
In relation to the claim ‘strength of balance’, the Panel ruled a breach of the following Clause of the 2021 Code as the claim as it appeared on the homepage was ambiguous and there was insufficient additional information to allow the reader to understand what it meant:
Breach of Clause 6.1
Making a misleading claim
In relation to the claim ‘strength of balance’ The Panel ruled no breach of the following Clauses of the 2021 Code given that the meaning of the claim, as it appeared on the homepage, was unclear, it was difficult to understand how it could be said to imply a special merit and the Panel did not consider that the complainant had established that the claim in question implied a special merit that could not be substantiated as alleged:
No Breach of Clause 6.2
Requirement that claims/information/comparisons must be capable of substantiation 
No Breach of Clause 14.4
Requirement that claims should not imply that a medicine or an active ingredient has some special merit, quality or property unless this can be substantiated 
In relation to the claim ‘delivering breakthroughs in RA and inflammation’, the Panel ruled no breach of the following Clauses of the 2021 Code because although the Panel was concerned about the phrase in question, in the particular circumstances of this case, the complainant had submitted no material and had not identified any specific evidence to support his/her position and the Panel did not consider that he/she had established his/her case on the balance of probabilities and in the absence of any evidence on this point, and on this very narrow ground alone, the Panel did not consider that the claim ‘delivering breakthroughs in RA and inflammation’ misleadingly implied that Jyseleca had a special merit that could not be substantiated:
No Breach of Clause 6.1
Requirement that information must be accurate, up-to-date and not misleading 
No Breach of Clause 6.2
Requirement that claims/information/comparisons must be capable of substantiation 
No Breach of Clause 14.4
Requirement that claims should not imply that a medicine or an active ingredient has some special merit, quality or property unless this can be substantiated. 
This summary is not intended to be read in isolation."
AUTH/3669/6/22 - Complainant v Small Pharma,Information about pipeline products on the Small Pharma website,29-Jun-22,AUTH/3669/6/22,2021,24-Jul-23,"2, 3.1, 5.1, 11.1, 16.1",5.1,Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3669622-complainant-v-small-pharma/,"This case was in relation to information about Small Pharma’s pipeline products on its website.
The Panel ruled a breach of the following Clause of the 2021 Code as it considered, noting the language used in relation to the pipeline products was strong and unqualified and the sensitive subject matter which was likely to be of interest to a wide audience including members of the public, in not making the intended audience clear, Small Pharma had failed to maintain high standards.
Breach of Clause 5.1
Failing to maintain high standards
The Panel ruled no breach of the following Clauses of the 2021 Code on the basis that:
• Clause 16.1 applied solely to prescription only medicines and therefore did not apply to the website
• the complainant had not established that provision of a link inviting viewers to ‘Stay up to date with our breakthrough R & D programs’ promoted a medicine prior to the grant of its marketing authorisation
• the complainant had not established their case in relation to the ‘DMT Training’ and therapy sections of the website
• in the particular circumstances of this case the ruling of a breach adequately covered the matter raised and an additional ruling of a breach of Clause 2 would be disproportionate.
No Breach of Clause 2
Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 3.1
Requirement that a medicine must not be promoted prior to the grant of its marketing authorisation
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 11.1
Requirement that a medicine must not be promoted prior to the grant of its marketing authorisation
No Breach of Clause 16.1
Requirement that promotional material about prescription only medicines directed to a UK audience which is provided on the internet must comply with all relevant requirements of the Code
This summary is not intended to be read in isolation."
AUTH/3672/6/22 - Complainant v Pfizer,Incorrect colour of the black triangle and reference to the Medicines and Healthcare products Regulatory Agency (MHRA) in press release,29-Jun-22,AUTH/3672/6/22,2021,30-Jun-23,15.2,5.1,Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3672622-complainant-v-pfizer/,"This case was in relation to a press release in the media section on the Pfizer UK website. 
The Panel ruled a breach of the following Clause of the 2021 Code because in its view, the black triangle was a well-known and established symbol and its appropriate use was an important part of medicines regulation and irrespective of the fact that its presence in a non-promotional press release was not a Code requirement, the failure to publish it in the correct colour within the press release was, at the very least, inappropriate and might potentially cause confusion:
Breach of Clause 5.1
Failing to maintain high standards
The Panel ruled no breach of the following Clause of the 2021 Code because the complainant had not established that the press release in question was promotional and therefore Clause 15.2 did not apply:
No Breach of Clause 15.2
Requirement that promotional material must not include any reference to the Commission on Human Medicines, the Medicines and Healthcare products Regulatory Agency (MHRA) or the licensing authority, unless this is specifically required by the licensing authority
This summary is not intended to be read in isolation."
AUTH/3670/6/22 - Health Professional v Novartis,Webinar registration page for Leqvio (inclisiran),30-Jun-22,AUTH/3670/6/22,2021,03-Jul-23,"2, 5.1, 6.1, 6.2, 11.2, 14.4","5.1, 12.9",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3670622-health-professional-v-novartis/,"This case was in relation to the registration webpage for a webinar entitled ‘Introducing an innovative approach to lipid management with inclisiran’. 
The Panel ruled a breach of the following Clauses of the 2021 Code in relation to the adverse event reporting statement because its position and font size on the webpage itself was such that it was not sufficiently prominent: 
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 12.9
Failing to include a prominent adverse event reporting statement
The Panel ruled no breach of the following Clause of the 2021 in relation to the adverse event reporting statement as it considered that the rulings of breaches of Clauses 12.9 and 5.1 adequately covered this matter:
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry 
The Panel ruled no breach of the following Clauses of the 2021 Code on the basis that the complainant had not established that:
• the title of the meeting misleadingly implied Leqvio was licensed for use for all types of lipid management and in children or was incapable of substantiation, and
• use of the word ‘innovative’ was a superlative or implied a special merit that could not be substantiated.
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry 
No Breach of Clause 5.1
Requirement to maintain high standards 
No Breach of Clause 6.1
Requirement that claims must not be misleading 
No Breach of Clause 6.2
Requirement that information must be capable of substantiation 
No Breach of Clause 11.2
Requirement not to promote a medicine for an unlicensed indication 
No Breach of Clause 14.4
Requirement that claims should not imply that a medicine or an active ingredient has some special merit, quality or property unless this can be substantiated. 
The Panel ruled no breach of the following Clauses of the 2021 Code in relation to the statement that allegedly solicited medical information questions on the basis that the complainant had not established that the inclusion of an invitation to contact Novartis for more information about inclisiran had resulted in responses that were not treated as promotional:
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry 
No Breach of Clause 5.1
Requirement to maintain high standards 
This summary is not intended to be read in isolation."
AUTH/3673/7/22 - Complainant v Daiichi Sankyo,Allegations about a press release for Nilemdo and Nustendi,01-Jul-22,AUTH/3673/7/22,2021,13-Sep-23,"6.1, 6.2","2, 5.1, 6.1",Undertaking received,Advertisement,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3673722-complainant-v-daiichi-sankyo/,"This case was in relation to a press release for Nilemdo (bempedoic acid) and Nustendi (bempedoic acid and ezetimibe) by Daiichi Sankyo UK Ltd.
The Panel ruled a breach of the following Clauses of the 2021 Code because the contraindication with simvastatin >40mg daily was not immediately apparent when reference to therapeutic use of Nilemdo with oral treatments to lower cholesterol was referred to, which was misleading. This might prejudice patient safety and was such as to reduce confidence in, and bring discredit upon, the pharmaceutical industry: 
Breach of Clause 6.1
Providing misleading information
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 2
Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
The Panel ruled no breach of the following Clauses of the 2021 Code because: 
• the statement with regard to Nustendi, unlike with Nilemdo, did not refer to its use with other lipid-lowering treatments and the complainant had not established why the contraindication was required
• it did not consider that the complainant had established that the information that NICE had ‘issued a Final Appraisal Document (FAD) recommending bempedoic acid and bempedoic acid / ezetimibe for treating primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet, only if statins are contraindicated or not tolerated, and ezetimibe alone does not control low-density lipoprotein cholesterol well enough, on the NHS in England’ was misleading as alleged
• the complainant had not provided reasons as to why, in their view, the press release was incapable of substantiation.
No Breach of Clause 6.1
Requirement that claims/information/comparisons must not be misleading 
No Breach of Clause 6.2
Requirement that claims/information/comparisons must be capable of substantiation 
This summary is not intended to be read in isolation."
AUTH/3678/8/22 - Complainant v AstraZeneca,Concerns about a Symbicort advertisement in MIMS,01-Aug-22,AUTH/3678/8/22,2021,04-Jul-23,,"2, 5.1, 6.1, 6.2, 11.2, 12.7",Undertaking received,Advertisement,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3678822-complainant-v-astrazeneca//,"This case was in relation to an advertisement for Symbicort (budesonide, formoterol fumarate dihydrate) in MIMS placed by AstraZeneca. 
The Panel ruled a breach of the following Clauses of the 2021 Code because: 
• the advertisement did not include reference to where the prescribing information could be found on the page of the advertisement, it was not visible
• the advertisement misleadingly implied that all strengths of Symbicort could be prescribed for MART [maintenance and reliever therapy] when Symbicort 400/12 should be used as maintenance therapy only and the points in small font at the very bottom of the page in question were wholly insufficient to qualify the misleading impression given and use of the higher Symbicort dose (400/12) for reliever therapy had the potential to impact patient safety 
Breach of Clause 2
Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 6.1
Making a misleading claim
Breach of Clause 6.2
Making an unsubstantiated claim
Breach of Clause 11.2
Promotion inconsistent with the SPC
Breach of Clause 12.7
Failing to include on the pages of a printed journal advertisement where the prescribing information was not visible, reference to where it could be found
This summary is not intended to be read in isolation."
AUTH/3679/8/22 - Complainant v CSL Vifor,Allegations about a promotional article in The British Journal of Cardiology,04-Aug-22,AUTH/3679/8/22,2019,04-Sep-23,"3.2, 7.2, 7.3, 7.4",7.9,Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3679822-complainant-v-csl-vifor/,"This case was in relation to claims within a Ferinject (ferric carboxymaltose) promotional supplement by Vifor in the British Journal of Cardiology.
The Panel ruled a breach of the following Clause of the 2019 Code as whilst the article in question referred to certain side effects, in the Panel’s view, this did not qualify the use of the word ‘safe’ in the key messages of the article:
Breach of Clause 7.9
Use of the word 'safe' without qualification.
The Panel ruled no breach of the following Clauses of the 2019 Code as:
• whilst the Panel had some concerns about the completeness of the information, the article did state the primary endpoint for CONFIRM-HF;
• noting that the primary endpoint of the study had been achieved and the claim clearly stated it was a post hoc analysis, the Panel considered, in the context of the article, that the complainant had not established that there was inadequate evidence for the claim ‘Post-hoc analysis of the CONFIRM-HF study supported the hypothesis that treatment with IV iron was associated with reduced hospitalisation’;
• whilst the Panel had concerns about the accuracy of data presented in a claim regarding a meta-analysis, the Panel, noting the very narrow allegation, considered that the complainant had not established that there was inadequate evidence;
• in relation to a table which only referred to study design, with no study results presented, the Panel considered that the complainant had not established that this table made a misleading comparison between ferric carboxymaltose and ferric derisomaltose:
No Breach of Clause 7.2
Requirement that claims must not be misleading
No Breach of Clause 7.3
Requirement that a comparison must not be misleading
No Breach of Clause 7.4
Requirement that claims must be capable of substantiation
The Panel, noting section 5.1 of the Ferinject SPC, ruled no breach of the following Clause of the 2019 Code as the complainant had not established that the claim ‘Heart failure with reduced ejection fraction is associated with iron insufficiency. Intravenous iron is a safe and effective treatment’, in the context of the article in question, promoted Ferinject off-licence:
No Breach of Clause 3.2
Requirement that the promotion of a medicine must be in accordance with the terms of its marketing authorisation and must not be inconsistent with the particulars listed in its summary of product characteristics
The Panel ruled no breach of the following Clause of the 2019 Code as, despite its ruling in relation to Clause 7.9, the article provided some information on side effects and therefore, in its view, a health professional was unlikely to be left with the impression that Ferinject had no side effects and therefore the Panel considered that the complainant had not established, on balance, that CSL Vifor had failed to maintain high standards;
No Breach of Clause 9.1
Requirement that high standards must be maintained at all times
This summary is not intended to be read in isolation."
AUTH/3680/8/22 - Voluntary admission by Astellas,Undeclared transfers of value,04-Aug-22,AUTH/3680/8/22,2021,18-Jul-23,2,"24.1, 24.4, 27.7, 5.1, 28.1, 31.1, 29.1",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3680822-voluntary-admission-by-astellas/,"This case was in relation to undeclared transfers of value to two healthcare organisations and five patient organisations between 2019 and 2021. 
The Panel ruled a breach of the following Clauses of the 2019 Code in relation to two payments made to the European Renal Association (ERA), one in 2019 and one in 2020, which had not been disclosed as part of its Annual Disclosure for these years and should have been published by 30 June 2020 and 30 June 2021, respectively:
Breach of Clause 24.1
Failure to publicly disclose certain transfers of value made directly to healthcare organisations located in Europe
Breach of Clause 24.4
Failure to disclose transfers of value annually within the first six months after the end of the calendar year in which the transfers of value were made
The Panel ruled a breach of the following Clauses of the 2021 Code in relation to two payments made in 2021, one to the ERA and one to the International Continence Society (ICS), which had not been disclosed as part of Astellas’ Annual 2021 Disclosure via the ABPI Disclosure Portal and should have been published by 30 June 2022:
Breach of Clause 28.1
Failure to publicly disclose certain transfers of value made directly to healthcare organisations located in Europe
Breach of Clause 31.1
Failure to disclose transfers of value annually within the first six months after the end of the calendar year in which the transfers of value were made
The Panel ruled a breach of the following Clause of the 2019 Code in relation to one payment made to Kidney Research UK in 2020 which had not been included in its 2020 patient organisation disclosure on the Astellas website by the end of June 2021:
Breach of Clause 27.7
Failure to disclose transfers of value to a patient organisation that must be done within the first six months after the end of the calendar year in which the transfers of value were made
The Panel ruled a breach of the following Clauses of the 2021 Code in relation to five payments to patient organisations made in 2021; two to Leukaemia Care, one to Kidney Care UK, one to Prostate Care UK and one to Duchenne UK, had not been disclosed as part of Astellas’ Annual 2021 Disclosure via the Astellas website by the end of June 2022:
Breach of Clause 29.1
Failure to publicly disclose transfers of value to a patient organisation
Breach of Clause 31.1
Failure to disclose transfers of value to patient organisations annually within the first six months after the end of the calendar year in which the transfers of value were made
Overall, the Panel ruled a breach of the following Clause of the 2021 Code as the disclosure of transfers of value was an important part of self-regulation and it considered that high standards had not been maintained:
Breach of Clause 5.1
Failing to maintain high standards
The Panel ruled no breach of the following Clause of the 2021 Code as it considered, on balance, that in the particular circumstances of this case, its ruling of a breach of Clause 5.1 was sufficient in relation to the failure to publicly disclose the healthcare organisation and patient organisation payments and an additional breach of Clause 2 was not warranted:
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
This summary is not intended to be read in isolation."
AUTH/3682/8/22 - Complainant v Accord,Conduct of a representative in relation to off-licence promotion of Methofill,05-Aug-22,AUTH/3682/8/22,2021,14-Jul-23,"2, 5.1","11.2, 17.2",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3682822-complainant-v-accord/,"This case concerned the conduct of a representative in relation to the off-licence promotion of Methofill (methotrexate).
The Panel ruled a breach of the following Clauses of the 2021 Code because in failing to inform a children’s gastroenterology nurse that use of Methofill in the treatment of Crohn’s Disease in children was outside of licence on receipt of the email request for materials and training devices, which the representative provided to the nurse later that day, the representative had promoted Methofill outside the terms of its marketing authorisation:
Breach of Clause 11.2
Promoting a medicine outside the terms of its marketing authorisation
Breach of Clause 17.2
Representative failing to maintain a high standard of ethical conduct
Accord appeared to have been let down by one employee; there was no evidence before it that similar interactions by other representatives had taken place. In this regard, and noting the actions of Accord once it was made aware of the representative’s actions which included immediately instructing the representative to contact the nurse to clarify the licence of Methofill, prior to the patient being seen in clinic, the Panel ruled no breach of the following Clauses of the 2021 Code: 
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 2
Requirement that activities must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
This summary is not intended to be read in isolation."
AUTH/3681/8/22 - Complainant v Tillotts,Conduct of a representative,10-Aug-22,AUTH/3681/8/22,2021,24-Jul-23,"2, 5.1, 17.5","17.2, 17.4",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3681822-complainant-v-tillotts/,"The Panel ruled a breach of the following Clauses of the 2021 Code because it considered that the wishes of the pharmacist were not observed and the interaction had caused inconvenience to the pharmacist and therefore, the representative had not complied with all relevant requirements of the Code:
Breach of Clause 17.2
Representatives failing to maintain a high standard of ethical conduct in the discharge of their duties and failing to comply with all relevant requirements of the Code
Breach of Clause 17.4
Failing to observe the wishes of individuals on whom representatives call and the arrangements in force at a particular establishment
The Panel ruled no breach of the following Clauses of the 2021 Code because it did not consider that it had been established that the representative had misled as to their identity or that of the company they represented as alleged, and its rulings of breaches of the Code adequately covered the matter and so in the particular circumstances of this case, an additional ruling of a breach of Clause 5.1 would be disproportionate and a ruling of a breach of Clause 2 was not warranted:
No Breach of Clause 2
Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry 
No Breach of Clause 5.1
Requirement to maintain high standards 
No Breach of Clause 17.5
Requirement that representatives must not mislead as to their identity or that of the company they represent.
This summary is not intended to be read in isolation."
AUTH/3689/8/22 - Voluntary admission by CSL Vifor,Promotional activities in relation to a Cardiology conference,05-Sep-22,AUTH/3689/8/22,2021,30-Aug-23,,"5.1, 8.1, 8.4",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3689822-voluntary-admission-by-csl-vifor/,"This was a voluntary admission by CSL Vifor which related to certain promotional activities at a cardiology conference in May 2022 that had not been certified as required by the Code. 
The Panel ruled a breach of the following Clauses of the 2021 Code as the promotional material in question had not been certified by a signatory notified in advance to the MHRA and PMCPA and therefore the promotional material had not been certified as required by the Code; certification underpinned self-regulation and the error was such that CSL Vifor had failed to maintain high standards: 
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 8.1
Failing to certify promotional material
Breach of Clause 8.4
Failing to notify in advance to the PMCPA and the MHRA the names and qualifications of those nominated as signatories
This summary is not intended to be read in isolation."
AUTH/3560/9/21 – Anonymous Health Professional v Sanofi,Conduct of a representative – Diabetes review service,26-Sep-22,AUTH/3560/9/21,2021,31-May-22,"17.2, 17.9",,,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth3560921-anonymous-health-professional-v-sanofi/,"An anonymous complainant who could not be contacted and who described him/herself as a nurse health professional complained about the conduct of a Sanofi diabetes representative.
The complainant stated that he/she worked within a named clinical commissioning group (CCG) and that the conduct of a named Sanofi representative had caused concern. The complainant stated that despite explaining to the representative that he/she did not want to sign up to a diabetes review service, the representative had continued to ask the complainant to sign up ‘as a favour’, which made the complainant feel pressurised and harassed.
The complainant stated that the named representative had previously been a good representative but would not be seeing him/her anymore; the complainant felt the representative had been pressurised into this behaviour by his/her superiors.
The detailed response from Sanofi is given below.
The Panel noted Sanofi’s submission that the account executive had no recollection of any concerns raised by any health professional on any topic, including the Diabetes Therapy Review Service and it did not find any evidence of any inappropriate conduct by the account executive or their manager in relation to activities with health professionals on the therapy review service. The Panel noted that it was impossible in such circumstances to determine precisely what had happened. The Panel noted, however, that extreme dissatisfaction was usually required on the part of an individual before he or she was moved to complain. The Panel noted that the complainant was anonymous and non-contactable and could therefore not be contacted for more information.
A judgement had to be made on the available evidence and on the balance of probabilities, noting that the complainant bore the burden of proof. The Panel did not consider that the complainant had established, on the balance of probabilities, that the representative in question had behaved inappropriately as alleged and therefore had failed to maintain a high standard of ethical conduct. No breach of the Code was ruled.
The Panel noted that the briefing material informed certain staff, including account executives, of what they needed to do if a health professional proactively discussed or requested the Diabetes Therapy Review Service. Account executives were instructed not to engage in any discussion about the service under any circumstances or make any comments even if requested by a health professional. Such enquiries were to be directed to the MSL.
The Panel did not have any evidence before it that the briefing document advocated, either directly or indirectly, any course of action which would be likely to lead to a breach of the Code as alleged. The Panel thus ruled no breach of the Code."
AUTH/3696/10/22 - Complainant v SOBI,,11-Oct-22,AUTH/3696/10/22,2021,27-Jul-23,"3.6, 5.1, 6.1, 6.2, 23.2, 26.1, 27.1",,,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth36961022-complainant-v-sobi/,"This case was in relation to an article sponsored by SOBI (Swedish Orphan Biovitrum Ltd) and published in the print and online versions of The Guardian.
The Panel ruled no breach of the following Clauses of the 2021 Code because:
• it did not consider that the complainant had established that the article advertised prescription only medicines to the public or that the article was disguised promotion
• it considered that the context of the phrase ‘without compromise’ was sufficiently clear in the heading ‘Taking steps to support people with haemophilia live life without compromise’ and the complainant had not provided any reasons to support the allegation that the phrase in question was ‘ludicrous’ and therefore had not established that it was either misleading or incapable of substantiation
• the complainant had not provided any detailed reasons to support their assertion that the statement in the article that Sobi was in “a unique position” because it was a small company was not a unique feature. The Panel considered that the statement in question primarily linked the company’s ‘unique position’ to its dedicated focus on rarer diseases, rather than its size and the complainant had not established that the claim at issue was misleading on the ground alleged
• it did not consider that mention of a tool called ‘liberation maps’ implied that patients would be liberated from haemophilia; the purpose of the tool appeared to be clear in the article and there was no evidence to support the complainant’s allegation that Sobi had mislead the reader by using the phrase ‘liberation maps’ or that there was a misleading implication that could not be substantiated
• in its view the statement regarding higher mortality rates in haemophilia referred to great strides having been made to improve therapies over the past 30 or 40 years, people with haemophilia having previously suffered from higher mortality and severe disabilities, it referred to an improvement in mortality rates over time and was not unqualified as alleged
• it did not consider that Sobi had linked the reference to sponsorships and grants to any Sobi medicines, either directly or indirectly such that the article was contrary to Clause 23.2 as alleged
• it noted that reference to wraparound services in the article in question referred to the fact that the condition was not just treated by the clinician but by a whole set of wraparound services, among other things and considered that the statement at issue appeared to be reasonably clear and the complainant had not established why failure to identify the services or explain the patient benefit rendered the statement in breach of the Code the complainant made very broad allegations in relation to ‘indirect attempts pharma companies made to indirectly promote drugs through advocacy group pressure’ but provided no evidence to support them it did not consider Sobi had failed to maintain high standards in relation to those matters within the scope of the complaint
No Breach of Clause 3.6
Requirement that materials and activities must not be disguised promotion
No Breach of Clause 6.1
Requirement that information must not be misleading
No Breach of Clause 6.2
Requirement that claims/information/comparisons must be capable of substantiation
No Breach of Clause 23.2
Requirement that grants and donations to healthcare organisations, patient organisations or other organisations do not constitute an inducement to recommend and/or prescribe, purchase, supply, sell or administer specific medicines
No Breach of Clause 26.1
Requirement not to advertise prescription only medicines to the public
No Breach of Clause 27.1
Requirement that when pharmaceutical companies interact with patient organisations or any user organisation, companies must not promote or request the promotion of a particular prescription only medicine
No Breach of Clause 5.1
Requirement to maintain high standards
This summary is not intended to be read in isolation."
AUTH/3701/10/22 - Astellas v Janssen,Nurse support service in prostate cancer – Erleada,24-Oct-22,AUTH/3701/10/22,2021,03-Aug-23,"2, 5.1, 19.1",,,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth37011022-astellas-v-janssen/,"This case was in relation to Janssen’s provision of a nurse support service for Erleada as part of a package deal which was alleged to be an inducement to prescribe as there were no additional monitoring requirements mandated in the Erleada SPC other than those for the standard management of prostate cancer patients.
The Panel ruled no breach of the following Clauses of the 2021 Code as it did not consider that Astellas had demonstrated that the package deal was inappropriate or was being offered as an inducement to prescribe Erleada as alleged.
No Breach of Clause 2
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 19.1
Requirement that no gift, pecuniary advantage or benefit may be supplied, offered or promised to health professionals or to other relevant decision makers in connection with the promotion of medicines or as an inducement to prescribe, supply, administer, recommend, buy or sell any medicine.
This summary is not intended to be read in isolation."
AUTH/3706/11/22 - Complainant v CSL Vifor,Alleged disguised promotion of Ferinject (ferric carboxymaltose),14-Nov-22,AUTH/3706/11/22,2021,17-Aug-23,"2, 5.1, 15.6, 23.1, 23.2",,,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth37061122-complainant-v-csl-vifor/,"The complainant alleged that CSL Vifor used a non-promotional service to increase the use of its medicine Ferinject (ferric carboxymaltose) by only offering the service to hospitals that used Ferinject and not targeting accounts where its competitor, Monofer (ferric derisomaltose), was the most commonly prescribed IV iron, and that this service offering was disguised promotion of Ferinject. 
The Panel ruled no breach of the following Clauses of the 2021 Code as it considered that the complainant had not established that CSL Vifor had used a non-promotional service to increase the use of its medicine Ferinject, nor that the service was disguised promotion of Ferinject, as alleged, noting that: 
• the complainant provided no evidence to support his/her allegation that the service was only offered in accounts that used Ferinject and not in accounts that used Monofer as the IV iron of choice;
• CSL Vifor submitted that in determining the focus of activity, the principal data sources used were not current treatment related but took account of Hospital Episodes Statistics (HES) data which looked at populations within CCGs such as the incidence of high blood loss surgery and the rates of anaemia detected in that group;
• whilst the Panel was concerned that the service in question was proactively offered by those who had a dual promotional/non-promotional role, it appeared these staff had been briefed to separate the discussion of the service from any promotional activity;
• the materials in relation to the service did not refer directly or indirectly to a specific IV Iron:
No Breach of Clause 2
Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 15.6
Requirement that promotional material and activities must not be disguised
No Breach of Clause 23.1
Requirement that donations are freely given for the purpose of supporting healthcare with no consequent obligation on the recipient organisation to provide goods or services to the benefit of the pharmaceutical company in return.
No Breach of Clause 23.2
Requirement that donations to healthcare organisations do not constitute an inducement to recommend and/or prescribe, purchase, supply, sell or administer specific medicines.
This summary is not intended to be read in isolation."
AUTH/3711/11/22 - Complainant v Novo Nordisk,Allegations about training for weight management services,21-Nov-22,AUTH/3711/11/22,2021,09-Mar-23,"2, 3.3, 5.1, 5.5, 8.1, 12.1, 15.6","5.1, 5.5",Undertaking received,,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth37111122-complainant-v-novo-nordisk/,"This case was in relation to a website and a number of associated documents that were developed in collaboration between Novo Nordisk and a named association which supported pharmacists in the UK.
The Panel ruled a breach of the following Clause(s) of the 2021 Code for failing to include a clear declaration of Novo Nordisk’s exact involvement on a weight management and obesity hub hosted on the association’s website and in the development of four different documents at the outset:
Breach of Clause 5.5
Failing to be sufficiently clear as to the company’s role and involvement
Breach of Clause 5.1
Failing to maintain high standards
The Panel ruled no breach of the following Clause(s) of the 2021 Code in relation to certain documents:
No Breach of Clause 5.5
Requirement to be sufficiently clear as to the company’s role and involvement
No Breach of Clause 15.6
Requirement that promotional materials and activities must not be disguised
No Breach of Clause 8.1
Requirement to certify promotional material
No Breach of Clause 12.1
Requirement to include prescribing information
No Breach of Clause 5.1
Requirement to maintain high standards
No Breach of Clause 3.3
Requirement to comply with an undertaking
No Breach of Clause 2 
Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
This summary is not intended to be read in isolation."
AUTH/3712/11/22 - Complainant v Abbvie,Promotion of Rinvoq,22-Nov-22,AUTH/3712/11/22,2021,18-Aug-23,"6.1, 6.2, 6.3","2, 5.1, 6.1, 6.2, 6.3",Undertaking received,Advertisement,No appeal,https://www.pmcpa.org.uk/cases/completed-cases/auth37121122-complainant-v-abbvie/,"This case concerned allegations about the suitability of imagery used on two Rinvoq (upadacitinib) webpages related to rheumatoid arthritis and psoriatic arthritis. 
The Panel ruled a breach of the following clauses of the 2021 Code on the basis that it considered: 
• the use of an image of a young female surfing on the webpage related to psoriatic arthritis might misleadingly imply that patients taking Rinvoq would be able to perform such strenuous exercise which in the Panel’s view was unlikely and which was compounded by the claim of ‘rapid and sustained joint efficacy’ and created a misleading impression in that it did not reflect the typical patient with moderate to severe psoriatic arthritis and could not be substantiated
• the image of a woman of childbearing potential on each webpage without including a reference to the fact it was contraindicated in pregnancy or the warning that women of childbearing potential should be advised to use effective contraception during treatment and for 4 weeks following the final dose of Rinvoq was misleading
• the use of imagery of a young female, in association with a product with a known risk of foetal harm, without highlighting that there were restrictions on use in this population had the potential to impact patient safety and was such that AbbVie had brought discredit upon, and reduced confidence in, the industry. 
Breach of Clause 2
Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Breach of Clause 5.1
Failing to maintain high standards
Breach of Clause 6.1
Failing to ensure material was sufficiently complete and not misleading
Breach of Clause 6.2
Making an unsubstantiated claim
Breach of Clause 6.3
Failing to ensure artwork conformed to the letter and spirit of the Code
The Panel ruled no breach of the following Clauses of the 2021 Code on the basis that:
• Rinvoq was licensed for rheumatoid arthritis and psoriatic arthritis in adult patients only. Therefore, the Panel did not consider that failure to include the warning, that female paediatric patients taking Rinvoq and/or their parents/caregivers should be informed about the need to contact the treating physician once the patient experiences menarche (starting menstruation), on the webpages at issue was, in the particular circumstances of the case, misleading or incapable of substantiation
• The complainant had not established that an image of a young female sitting on a swing swinging on the rheumatoid arthritis webpage was not representative of a typical patient with moderate to severe rheumatoid arthritis; while some fitness was required to generate the swinging movement, the activity did not appear to require particular stability or strength in the joints.
No Breach of Clause 6.1
Requirement that material must be sufficiently complete and not be misleading 
No Breach of Clause 6.2
Requirement that claims and information must be capable of substantiation
No Breach of Clause 6.3
Requirement that all artwork must conform to the letter and spirt of the Code
This summary is not intended to be read in isolation."