Case Summary
An anonymous ‘concerned UK health professional’ complained that the inverted triangle symbol throughout Napp Pharmaceutical’s website was the incorrect colour and might confuse health professionals. The complainant provided a link to a page on the website in question on which the inverted triangles next to the brand name of two medicines were dark grey, not black.
The detailed response from Napp is given below.
The Panel considered the complaint in relation to health professionals and material directed at them.
The Panel noted that the Code required the inverted black triangle symbol to be included on material which related to a medicine which was subject to additional monitoring and which was intended for a patient taking that medicine. The Panel considered that the complainant had not established that the product webpage directed at health professionals was promotional and thus no breach of the Code was ruled in relation to the requirement for inverted black triangles on promotional material.
In the Panel’s view, the inverted black triangle was a well-known and established symbol. Its appropriate use was an important part of medicines regulation. Thus, in the Panel’s view, failure to publish the triangle in the correct colour was, at the very least, inappropriate and might potentially cause confusion. This was a serious matter. The Panel considered that high standards had not been maintained and ruled a breach of the Code.
CASE AUTH/3110/10/18 ANONYMOUS v NAPP
Colour of inverted triangle symbol
An anonymous ‘concerned UK health professional’ complained that the inverted triangle symbol throughout Napp Pharmaceutical’s website was the incorrect colour and might confuse health professionals. The complainant provided a link to a page on the website in question on which the inverted triangles next to the brand name of two medicines were dark grey, not black.
The detailed response from Napp is given below.
The Panel considered the complaint in relation to health professionals and material directed at them.
The Panel noted that the Code required the inverted black triangle symbol to be included on material which related to a medicine which was subject to additional monitoring and which was intended for a patient taking that medicine. The Panel considered that the complainant had not established that the product webpage directed at health professionals was promotional and thus no breach of the Code was ruled in relation to the requirement for inverted black triangles on promotional material.
In the Panel’s view, the inverted black triangle was a well-known and established symbol. Its appropriate use was an important part of medicines regulation. Thus, in the Panel’s view, failure to publish the triangle in the correct colour was, at the very least, inappropriate and might potentially cause confusion. This was a serious matter. The Panel considered that high standards had not been maintained and ruled a breach of the Code.
An anonymous contactable complainant who described him/herself as a ‘concerned UK health professional’ complained about the colour of the inverted triangle symbol on Napp Pharmaceutical Limited’s website.
COMPLAINT
The complainant alleged that the inverted triangle symbol throughout Napp’s website was the incorrect colour and that this might confuse health professionals. The complainant provided a link to a page on the website in question on which the inverted triangles next to the brand name of two medicines were dark grey, not black.
When writing to Napp, the Authority asked it to consider the requirements of Clauses 4.10 and 9.1 of the Code.
RESPONSE
Napp submitted that it took the Code very seriously and aimed to maintain high standards at all times.
Napp noted the rulings in a similar case, (Case AUTH/3049/6/18).
Napp noted that Clause 4.10 stated that all promotional material must show an inverted black equilateral triangle to denote that additional monitoring was required. The black triangle symbol had been used for this purpose for many years and was well known to UK health professionals. The supplementary information to Clause 4.10 stated that the symbol should always be black and in digital communications the size must be easily readable. Napp acknowledged and agreed with the complainant that the font colour of the black triangle was bold dark grey (the text was also dark grey) on the non-promotional corporate website product pages. Napp had removed these pages from the website until the error was corrected.
Napp disagreed that this oversight was a breach of Clause 4.10 because a black triangle was only required to be included on promotional material. Napp submitted that the product pages of the
Napp UK corporate website were non-promotional. The material in question was approved by an experienced medical final signatory.
Napp denied a breach of Clause 9.1 and stated that, as part of the spirit of the Code, certain oversights should not automatically constitute a fall in high standards. Napp noted that the complainant had referred to confusion amongst health professionals. As already stated the black triangle symbol had been used for many years in the UK so it was well known to health professionals. A subtle colour change from black to dark grey therefore was highly unlikely to result in confusion. Indeed, depending on computer monitor colour and contrast settings, dark grey might appear as black. This was the case for a number of Napp employees who thought the triangle was black on their computer screen. The final signatory had an additional privacy screen/filter over his/her computer screen which darkened the screen contrast. Whilst Napp acknowledged that the triangle was not black it was confident that if a health professional viewed the webpage, there would be no confusion as to what the triangle represented in terms of monitoring requirements. In the spirit and the principle of the Code, Napp contended that the bold dark grey colour of a black triangle would not jeopardise additional monitoring. Napp asked what overwhelming proof the complainant had provided that this would be the case. This would be more understandable if the symbol was a distinct colour change such as green or red, which it was not. The product pages in question on the Napp website included the names of the medicines with dark grey bold triangles where required, and links to the electronic medicines compendium (eMC) so as to be able to view the relevant summary of product characteristics (SPC) and patient information leaflet (PIL). The first landing page of the SPC and PIL also contained prominent black triangles.
In summary, Napp accepted that it had inadvertently used a dark grey instead of a truly black inverted triangle on some medicines on its corporate non promotional website. It had immediately taken down the webpages affected until corrected. However, for the reasons provided above, Napp did not agree that the mistake constituted breaches of either Clause 4.10 or 9.1.
PANEL RULING
The Panel noted that the complainant referred to the colour of the black triangles throughout Napp’s website and provided a link to a specific webpage, the URL of which referred to health professionals. It appeared that the link provided by the complainant, despite the URL, linked to a webpage directed at patients which was closely similar to that on the Napp website directed at health professionals. The Panel noted Napp’s submission that it had immediately removed the webpage at issue from the website when it was informed of the complaint. The complaint referred to material throughout the website potentially confusing health professionals. The Panel considered the complaint in relation to health professionals and material directed at them.
The Panel noted Napp’s submission that the product pages of the Napp corporate website were nonpromotional. The Panel noted that the biosimilars product page directed at health professionals included the medicines’ names and links to the electronic medicines compendium where the reader could view the SPC and PIL. The indication was not stated.
The Panel noted that Clause 4.10 stated that when required by the licensing authority, all promotional material must show an inverted black equilateral triangle to denote that additional monitoring was required in relation to adverse reactions. The Panel noted that contrary to Napp’s view, it was not only promotional material that required the inclusion of a black triangle. The Panel noted that in addition, Clause 26.3 required the inverted black triangle symbol to be included on material which related to a medicine which was subject to additional monitoring and which was intended for a patient taking that medicine. The Panel noted that Clause 4.10 only required an inverted black triangle to be included on promotional material and considered that the complainant had not established that the product webpage directed at health professionals was promotional and thus no breach of Clause 4.10 of the Code was ruled.
In the Panel’s view, the inverted black triangle was a well-known and established symbol. Its appropriate use was an important part of medicines regulation. Thus in the Panel’s view, failure to publish the triangle in the correct colour was, at the very least, inappropriate and might potentially cause confusion. This was a serious matter. The Panel considered that high standards had not been maintained. A breach of Clause 9.1 was ruled.
Complaint received 29 October 2018
Case completed 3 January 2019
