AUTH/3203/6/19 - Health professional employee v Otsuka Europe

Alleged promotion of information on company website

  • Received
    07 June 2019
  • Case number
    AUTH/3203/6/19
  • Applicable Code year
    2019
  • Completed
    23 April 2020
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    To be published in the review

Case Summary

An anonymous employee who described him/herself as a concerned health professional, complained that Otsuka UK webpages promoted prescription only medicines to the public. The webpages were part of the Otsuka Europe website and the matter was taken up with Otsuka Europe.

The complainant stated that as the Otsuka UK website products page listed the brand names, non-proprietary names and indications of the medicines sold by Otsuka UK, it promoted them to the public and encouraged patients to ask their health professionals for these medicines. The webpages did not specify who the intended audience of the website was and contained links to the Japan website which promoted products not available in the UK as well as a link to the pipeline of products which should not be aimed at the general public or patients as it raised unfounded hopes of treatments and promoted those that were available in various countries in Europe including the UK.

The complainant was disappointed to see promotional information on the website, especially after the recent cases that had been published regarding company websites. When a case was published, the complainant hoped that other companies would review their own practice and learn from the mistakes of others. This appeared not to be the case.

The complainant provided screenshots of webpages which referred to Abilify (aripiprazole), Samsca (tolvaptan), Jinarc (tolvaptan) Sprycel (dasatinib) and Pletal (cilostazol).

The detailed response from Otsuka Europe is given below.

The Panel noted Otsuka’s submission that the webpage in question formed part of the Otsuka Europe website and could be reached by one of two ways; directly by clicking on the ‘Our Products in Europe’ link at the bottom of the home page of the Otsuka UK section of the website or indirectly by clicking on ‘What We Do For Patients’ at the top of the same page. The latter took the reader to a webpage that listed the therapeutic areas for Otsuka medicines and scrolling down the page led to a section that displayed the brand and non-proprietary name (but not the indication) in separate squares for each of Otsuka’s medicines licensed in the UK. If the readers clicked on any of the medicine names or the ‘Read more’ button which appeared to the right of the squares, he/she was taken directly to the webpage in question.

The Panel noted that it appeared that there was a third way of reaching the webpage in question: if a reader clicked on ‘What We Do For Patients’ there were five options to select from on the right hand side of the page including ‘Therapeutic Areas’ and below this ‘Our Products in Europe’ which the Panel assumed also took the reader to the webpage in question.

The Panel noted that the ‘Therapeutic Areas’ section referred to above stated, inter alia, that in Europe, Otsuka was focused on central nervous system (CNS) disorders, endocrinology, nephrology and oncology before inviting readers to visit the global website for more information about Otsuka’s global portfolio and the Otsuka Holdings website for information on pipeline products. This was followed by a section on CNS Disorders which began by stating that ‘Otsuka’s commitment to providing innovative solutions for central nervous system (CNS) disorders began more than 30 years ago, when our researchers took the first steps in the creation of a drug that would eventually provide a new treatment option for millions of sufferers of schizophrenia and bipolar disorder’. It also stated ‘While creating new products we put emphasis on providing robust evidence to regulatory authorities showing that any new drugs offer an improvement on what has gone before and that they represent good value in terms of improving patient outcomes’.

The Panel noted Otsuka’s submission that on reaching the webpage in question there was a statement at the top of the page that all Otsuka medicines were prescription-only medicines, and that the reader should refer to the summary of product characteristics (SPC) or patient information leaflet (PIL) if more information was required. The names, indication and link to the relevant SPC and PIL was then listed for all Otsuka medicines licensed in the UK. The Panel noted Otsuka’s submission that for each medicine listed the link to the relevant SPC and PIL was provided immediately after the reference to the medicine. The reader would have to scroll down the list of medicines in order to see all the brand names, non-proprietary names and indications. According to Otsuka the link provided for each SPC and PIL was a direct, single click link to the relevant document on the Electronic Medicines Compendium. The Panel further noted Otsuka’s submission that there were no claims made for any of the medicines, specifically or more generally and that the information provided constituted reference information as permitted by the Code.

The Panel considered that the information about each product on the webpage for the public was not unacceptable in relation to the requirements for reference information (as referred to in the supplementary information to the Code), the Panel noted that the webpage in question listed the product names and indications for all of Otsuka’s prescription only medicines within one screen. As far as the Panel was aware, whether a reader clicked on a specific medicine or the ‘Read more’ button referred to above, he/she was taken to the top of the webpage in question and would then have to scroll down to find the medicine he/she wanted to find out more about. The Panel noted that Otsuka carried out compliance monitoring of digital activities including its websites in March 2019 and the report provided by Otsuka stated that an observation in relation to the Otsuka UK website was that the product pages included product name, generic name and indication and there was a risk that this could be seen as encouraging the public to ask for a specific medicine and promotion to the public. The recommendation given was to review and update the wording on the products section of the UK website. The Panel considered that given the information on the ‘Therapeutic Areas’ section of the UK website and the fact that members of the public looking for information on a particular product would see the name and indication for all of Otsuka’s products, meant that the webpage advertised prescription only medicines to the public and, on balance, a breach of the Code was ruled. The Panel considered that, on the balance of probabilities, the information might encourage members of the public to ask their health professional to prescribe a specific prescription only medicine and, on balance, ruled a breach of the Code.

The Panel noted that supplementary information to the Code included that unless access to promotional material about prescription only medicines was limited to health professionals and other relevant decision makers, a pharmaceutical company website must provide information for the public as well as promotion to health professionals with the sections for each target audience clearly separated and the intended audience identified. This was to avoid the public needing to access material for health professionals unless they chose to. The MHRA Blue Guide stated that the public should not be encouraged to access material which was not intended for them. The Panel noted its comments and ruling above. In the Panel’s view, the webpage at issue promoted prescription only medicines and therefore access should have been restricted to health professionals and other relevant decision makers because information had not been provided for the public as required by the relevant supplementary information. The Panel noted that access to the webpage had not been so restricted and therefore a breach of the Code was ruled.

The Panel noted its comments and rulings above and considered that Otsuka had failed to maintain high standards and a breach of the Code was ruled.

The Panel noted the complainant’s allegations that the website contained links to the Japanese website which promoted products not available in the UK as well as a link to the pipeline of products which should not be aimed at the general public or patients as it raised unfounded hopes of treatments. Otsuka made no submission with regard to the latter. In the Panel’s view, it was not necessarily unacceptable for a company to refer in general terms to its pipeline products on its corporate website, however language, context, location, layout, intended audience and overall impression were important factors when deciding whether such references were acceptable. Such references should not otherwise constitute promotion of an unlicensed medicine. The Panel did not have before it a copy of the webpages which referred to Otsuka’s pipeline products. Whilst the Panel had concerns about the context in which the link was provided, it noted that based on the very narrow allegation, the complainant had not explained why he/she considered the page on pipeline products raised unfounded hopes of treatments for the general public or patients nor had he/she provided evidence in this regard. The Panel noted that pipeline products, were not classified as prescription only medicines and no breach of the Code was ruled.

The Panel noted that the complainant bore the burden of proof and did not consider that he/she had established that the link to the Japanese organisation’s website was inappropriate as alleged. A pop-up box made it very clear that the reader was leaving a website under Otsuka Europe’s control and going to a website, the content of which was not Otsuka Europe’s responsibility. The link was to the home page rather than a product page or similar. The Panel ruled no breach of the Code.

The Panel did not consider that the particular circumstances in this case warranted a ruling of a breach of Clause 2 which was a sign of particular censure and reserved for such. No breach of the Code was ruled.