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AUTH/2972/8/17 - Anonymous healthcare journalist v UCB

Case number:AUTH/2972/8/17
Case ref:Anonymous healthcare journalist v UCB
Description:UCB website
No breach:No breach Clauses 14.3 and 26.3
Breach:Breaches Clauses 2, 7.2, 9.1, 14.5 and 26.2
Appeal:No appeal
Status:Breach ruled, case report pending
Review:Published in the February 2018 Review
Received:18/08/2017
Completed:19/12/2017
Case Summary:

An anonymous, non-contactable complainant who stated that he/she was a healthcare journalist submitted a complaint about the UCB Pharma website. The complainant provided annotated screenshots. There were four allegations.

Firstly, the complainant alleged that the section labelled ‘UCB’s product list’ stated that this information was ‘specific to the UK’. However, it mentioned several products that were not part of UCB UK’s portfolio.

The complainant alleged that inaccurate, misleading information about prescription only medicines was provided to the public (ie by placing on a website freely available to the public) and high standards had not been maintained.

The detailed response from UCB is given below.

The Panel noted UCB’s submission that the available product list on its website was published as proactive reference information directed to a public audience. The Panel considered that the list in question was neither factual nor accurate and was thereby misleading. Breaches of the Code were ruled.

The Panel noted that the website listed 19 products that were no longer marketed by UCB but were, according to UCB, still available in the UK from other manufacturers. The Panel considered that, as acknowledged by UCB, its poor governance of the website meant that high standards had not been maintained and a breach was ruled.

Secondly, the complainant alleged that ten items were not recertified after two years, as required by the Code. High standards had not been maintained.

The Panel noted UCB’s submission that in relation to the materials listed by the complainant posted in the ‘Therapy area’ section of its website, none had been re-certified after two years. The Panel ruled a breach of the Code in relation to each of the 10 items.

The Panel noted that a robust certification procedure underpinned self-regulation. The Panel considered that UCB’s failure to review and re-certify material aimed at the public or patients meant that it had failed to maintain high standards. A breach of the Code was ruled.

The Panel noted that the educational materials listed had all been certified in advance between August and October 2012 and the Panel ruled no breach of the Code in this regard.

Thirdly, the complainant referred to three separate press releases on Briviact (brivaracetam) January 2016; July 2016, October 2016 and alleged that each had a ‘black triangle’ which was a requirement for promotional materials only (as required by Clause 4.10 of the Code). Press releases by definition should be non-promotional and hence would not require black triangles. The complainant pointed out that when one clicked on the links to read the press releases, the triangles actually appeared ‘orange coloured!’ The complainant alleged that high standards had not been maintained.

The Panel noted UCB’s submission that the press releases were non-promotional and informed the intended audience of medical, trade and consumer journalists about the availability of Briviact (brivaracetam) in the NHS.

The Panel noted that material which related to a medicine and which was intended for patients taking a medicine which was subject to additional monitoring, an inverted black equilateral triangle must be included on it together with a statement about additional monitoring and reporting of side-effects. The Panel noted that contrary to the complainant’s view, it was not only promotional material that required the inclusion of a black triangle. The Panel ruled no breach of the Code as it considered that the press releases were not specifically intended for patients taking the medicine.

The Panel considered that although there was no requirement to include the black triangle within press releases, its inclusion and accompanying explanatory text was, nonetheless, a prudent approach given the intended audience of medical, trade and consumer journalists and that it was likely that the journalists would ultimately disseminate the information to health professionals and members of the public.

The Panel noted that the inclusion of the inverted black triangle on press releases was not a Code requirement. In the Panel’s view, it was a wellknown and established symbol. Its appropriate use was an important part of medicines regulation. Thus, in the Panel’s view, irrespective of the fact that its presence was not a Code requirement, the failure to publish the triangle in the correct colour across three press releases was, at the very least, inappropriate and might potentially cause confusion. The Panel also noted the complainant’s comment that the company had not been meticulous or thorough enough to check whether the triangles were the required colour. High standards had not been maintained. A breach of the Code was ruled. Finally, the complainant queried whether anyone at UCB checked and kept an eye on its website.

The Panel noted its rulings and comments above. The Panel noted the number of materials intended for patients which had not been correctly recertified and the number of products that were incorrectly listed on its website. In the Panel’s view, a robust certification procedure underpinned self-regulation. It was of concern that UCB only became aware of such matters on notification of the complaint rather than as a result of its own compliance oversight. The company’s compliance failure in relation to these matters was compounded by the fact that they appeared to be longstanding; the earliest educational item was dated August 2012 and therefore ought to have been the subject of re-certification on two occasions. This was unacceptable, particularly in relation to materials directed at the general public including patients. No adequate explanation for the errors had been provided. The Panel considered that UCB’s failure to review and re-certify materials aimed at the public or patients and the poor governance of its website which appeared to be longstanding meant that it had brought the industry into disrepute. A breach of Clause 2 was ruled. ​