AUTH/3108/10/18 - Complainant v Mitsubishi Tanabe Pharma Europe

Mitsubishi Tanabe Website

  • Received
    29 October 2018
  • Case number
    AUTH/3108/10/18
  • Applicable Code year
    2016
  • Completed
    20 February 2019
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    Published in the May 2019 Review

Case Summary

A complainant who described him/herself as a concerned UK health professional complained about four pharmaceutical companies’ websites including that of Mitsubishi Tanabe Pharma Europe who market Exembol (argatroban – used for anticoagulation in certain adult patients) and Tanatril (imidapril – indicated for the treatment of essential hypertension in adults) in the UK. 

The complainant noted that Mitsubishi Tanabe Pharma Europe was based in London.  The complainant drew parallels with another company’s website which he/she had complained promoted to the general public because there was information including the generic name, the brand name and the indication.  The complainant stated that Mitsubishi Tanabe Pharma Europe’s website similarly had no separate area for patients and merely stated that certain pages were for patients and that the product pages were similarly promoting to the general public, particularly if one selected the ‘read more’ button. 

The detailed response from Mitsubishi Tanabe Pharma Europe is given below.

The Panel noted Mitsubishi Tanabe Pharma Europe’s submission that its website was intended to provide corporate information in relation to the company and its products at a European level; and that the webpages in question were not promotional and provided accurate, factual information for health professionals and the public in relation to Exembol and Tanatril.

The Panel noted the webpage in question contained statements related to argatroban (non-proprietary name for Exembol) and Tanatril. 

In relation to argatroban, the webpage stated:

‘Developed in Japan, argatroban was the first licensed synthetic direct thrombin inhibitor. Approved in twelve European countries, argatroban is marketed for anticoagulation in adult patients with Heparin-Induced Thrombocytopenia Type II (HIT Type II) who require parenteral antithrombotic therapy. Argatroban is given as a continuous intravenous infusion.’

The same page had the following statement in relation to Tanatril:

‘Tanatril is used to treat high blood pressure (hypertension).  Tanatril is one of a group of medicines called ACE (angiotensin-converting enzyme) inhibitors.  Tanatril is available in 5mg,

10mg and 20mg tablet formulation.’

The Panel noted that there was a ‘read more’ button within the highlighted text box for each product and to the right of the page an adverse event reporting statement.  At the bottom of each webpage within the products section, in small font, was the statement ‘Please note: certain pages are intended for healthcare professionals only’.  The Panel noted that the ‘certain pages’ were not identified and thus in the Panel’s view the intended audience for each page was unclear.  The section did not clearly separate pages aimed at health professionals from those containing information for the public.  The Panel also noted Mitsubishi Tanabe’s submission that the webpages were non-promotional and there was accordingly no requirement to restrict access.

The Panel noted that if the ‘read more’ button was selected for argatroban, the user was taken to a page which repeated the argatroban statement above and further stated: ‘You can find specific information on our products in individual countries by choosing the relevant country from the menu below’.  The four brand names for argatroban were listed with links to the relevant country/ countries for each.  If the user selected the UK link for Exembol, a pop-up box appeared stating that the following pages were intended for viewing by UK health professionals only.  If the user selected ‘continue’ the user was taken to a page that contained: links to the Exembol summary of product characteristics and patient information leaflet; contact details for Mitsubishi Tanabe Pharma Europe; an adverse event reporting statement; and a link to an Exembol website.  If the user had selected ‘cancel’ in response to the pop-up box, he/she would stay on the current page. 

The Panel further noted that when the user selected the Tanatril ‘read more’ button from the main product webpage, he/she would be taken to a page titled ‘How to order Tanatril’ which gave information regarding ordering the product from a named wholesaler, including the wholesaler’s contact details and the PIP codes for each tablet strength.  The same page featured: links to the Tanatril summary of product characteristics and patient information leaflet; Mitsubishi Tanabe Pharma Europe’s contact details; and an adverse event reporting statement.  The bottom of the page stated: ‘Please note: certain pages are intended for healthcare professionals only’.  The Panel noted its comments on this statement above.  The content of this page was such that it appeared to be aimed at health professionals.

The Panel queried whether the products homepage and the pages linked via the read more buttons could be considered reference information as set out in the supplementary information of the Code given the lack of information provided for members of the public.  There appeared to be nowhere for members of the public to go to access further information on argatroban; the SPC and PIL could only be accessed after the reader confirmed that he/she was a health professional.  The page for Tanatril, which included the SPC and PIL, related to how to order the product and appeared therefore to be aimed at health professionals.

The Panel considered that the statement ‘… argatroban was the first licensed synthetic direct thrombin inhibitor.  Approved in twelve European countries …’ which appeared, inter alia, on the main product webpage constituted a product claim.  The Panel noted that whilst the homepage of the products section in question did not include the brand name for argatroban it did include its non-proprietary name and indication.  If a member of the public clicked on the read more button for argatroban they were provided with the brand name of the product in individual countries including Exembol in the UK.  The initial webpage also included the brand name and indication for Tanatril.

The Panel also noted that members of the public looking for information on one particular medicine would automatically be faced with the non-proprietary or brand name and indication of Mitsubishi Tanabe Pharma Europe’s other medicine. 

Noting its comments above the Panel considered that the webpage advertised prescription only medicines to the public and a breach of the Code was ruled.  

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 Mitsubishi Tanabe Pharma Europe had failed to maintain high standards and a breach of the Code was ruled.

The Panel did not consider that the circumstances in this particular case warranted a ruling of a breach of Clause 2 and no breach was ruled accordingly.