Delegates from last year’s eyeforpharma eMarketing Europe had indicated that more insight into the thinking of regulators would be very helpful, so Heather Simmonds of the UK’s Prescriptions Code of Practice Authority bravely took the stage to discuss the changing landscape, both in the UK and across Europe.
The very different interpretations of what constitutes “promotion to patients” by different countries does not help companies trying to establish a European strategy. France and Germany consider the mention of a drug name to be “promotion” whereas the UK guidelines allow and even encourage companies to provide “reference information” i.e. factual information about medicines, to consumers, provided it is balanced, accurate and not misleading (check out clause 24 of the ABPI Code of Practice 2008). She observed that in the UK many pharma marketers are currently not doing what they are allowed to do within the code, so why ask for codes to be broadened?
Consequently different countries are reacting differently to the proposed European Directive on information to the public about prescription only medicines – effectively this will relax the rules in some countries and tighten them in others.
The codes in many cases are already in place and just need to be interpreted for online. For example, information you can provide in a closed meeting to doctors can probably be provided in a closed website to doctors.
It only becomes an issue when the translation is not direct – for example, a passing question and answer in conversation, becomes a permanent record when written in a forum or blog – and as soon as that permanence is established it must be treated as a document and comply with the relevant code of practice.
Context is also important: a piece of patient information in one context might be balanced and neutral, but choosing a phrase from that information and displaying it differently might be deemed promotional.
Heather’s plea was to involve the regulators. They want to help us achieve goals of better medical education and healthcare and the discussion can be about not “can we or can’t we?” but “how can we?”
Notwithstanding this debate, the question still stands: in a global channel, if a piece of content is for a “global audience” whose national rules apply? It is not practical to consult every code in the world just in case a citizen of that jurisdiction comes across the content. Further, during a panel discussion, Silja Chouquet of Whydot.com asked “Who has lied about being from the US to gain access to one of their consumer websites?” A handful of hands stayed down – the US delegates, of course.