Key Topic 1 - Subtopic 1: Above country and national websites
It is acceptable to create websites that are directed at geographic regions, rather than individual countries. However, the codes and regulatory jurisdiction for above country websites are uncertain and it is possible that any one (or more) regulatory authority could consider that its national rules apply, especially if any reference to that country (e.g., local product availability) is included.
AstraZeneca therefore prefers, wherever feasible, to provide national sites approved to national rules but based upon common content. Core content, approved through the global team review procedures can be used as the basis for national content.
Unless above country websites in English have been approved by the UK or US approval procedures, a prominent notice should be included indicating that the site is not intended for US/UK visitors and providing alternative links to relevant UK and US sites. Links should also be included for other national visitors where appropriate national sites exist.
Consider this example
A complaint was made in the UK that an advertisement for Enbrel (etanercept), marketed by Wyeth, which appeared on www.yahoo.com, constituted direct to consumer advertising. The complainant stated that there was a small ‘get-out’ clause buried on one of the inside pages of the advertisement, which stated that the message was only for the attention of US residents and that other countries had different regulations related to the use of medicines. However, by the time anybody reached that section they would have already read the advertisement that advised anybody with severe arthritis, and not getting sufficient relief, to ask their prescriber about Enbrel.
The Panel noted that various pages of the advertisement stated ‘This site is intended for US audiences only’. Also the advertisement had been placed by the US company not Wyeth UK.
Which of the following do you agree with?
- As anyone could access this advert it constitutes promotion to the public the intended audience was clear and appeared on various pages
- The intended audience is clearly stated and so this is not promoting to a UK audience
- Wyeth UK cannot be held responsible as they did not place this advert on YouTube a UK company can be held responsible for material placed on the internet by one of its affiliates, if the content is directed to a UK audience.
The Panel considered that although accessible to anyone, the website at issue was directed to a US audience; further, the advertisement itself did not address a UK audience. The material was thus not directed to a UK audience and so the Panel ruled no breach of the UK regulations.
