Social media and the ABPI Code - a recent case of dos and don'ts
Dr Rina Newton
CompliMed Ltd.
Mirror, signal, manoeuvre.
This is what we are taught when learning to drive and intending to make a turn.
If the turn takes place in a different country, on different roads or in a different car then the principles of making a safe turn don't change…
The point is we apply learnt principles all the time in everyday life (even if we have long forgotten the actual theory). When faced with a new environment, we don’t reinvent the principles. We adapt, apply what we already know and carry on.
Turning this analogy to Twitter and Code compliance….understanding and applying well-established Code principles, as well as truly realising intent can turn a social media strategy into meaningful and compliant execution.
Promoting a prescription-only-medicine to the public breaches the Code and is illegal. It therefore follows that tweets about POM medicines should consider the following key questions:
• Is this in line with business strategy?
• Is the intention to promote that medicine?
• Does the target audience include the public?
• Is the company involved in the dissemination of the message?
As a minimum, staff involved with execution should understand the basic definitions around what constitutes 'promotion', company involvement etc.
"...understanding and applying well-established Code principles, as well as truly realising intent can turn a social media strategy into meaningful and compliant execution."
Had Bayer UK / Ireland’s Twitter service aimed to answer these questions, their eventual actions may have been different......As it stands, one of their tweets started: “First and only melt-in-the-mouth erectile dysfunction treatment launched by Bayer today……”. Such a claim clearly identified the product, highlighted a benefit and linked to a press release on the Bayer website. Another tweet mentioned the product name, availability and indication for use.
Unsurprisingly Bayer were deemed to have breached the Code because these tweets promoted products to the public and encouraged members of the public to ask their Dr to prescribe specific prescription-only-medicines.
Bayer accepted the rulings, citing that "this case had greatly assisted Bayer to establish what use could be made of digital media". But I'm not sure that we have learnt anything new. Yes it's the first ruling in this area, but has it redefined the rulebook? Not really.....because it has been illegal to promote to the public in the UK for many, many years.
Which leads us to believe that this is less about establishing new guidelines and more about being aware of and correctly interpreting the existing ones. A digital strategy requires social media as one of many communication, engagement and marketing tools. But realising that compliance is a thread that weaves right through from strategy to execution and beyond, can mean simple mistakes can be avoided and untested concepts can be confidently approached.
With all digital communications there are real possibilities to explore.... replies to individual unsolicited enquiries, legitimate public relations activities, factual announcements, genuine promotion.......as long as we are clear from the start which of these 'buckets' we're talking about. In other words, we've answered the key questions and we make the communication fit - fit for purpose and fit compliantly.
"Had Bayer UK / Ireland’s Twitter service aimed to answer these questions, their eventual actions may have been different"
It seems probable that of all the possible buckets, the one that seems to cause the most conservative approach is promotion - probably because recent PMCPA Guidance on this area commented that because of Twitter's limit of 140 characters per message "it is highly unlikely that the use of this medium to promote prescription only medicines would meet the requirements of the Code”. Not impossible then.
The Code does require some important information to be present on promotional material, such as prescribing information, non-proprietary name adjacent to the most prominent display of the brand name, black triangle if required and so on. But the Code also states that promotional material on the internet can include a statement as to where prescribing information can be found (with a link to it). This begs the question then around other electronic promotional messages such as those on mobile devices.
What is undoubtedly very clear from the Code is that if the intent is to promote via Twitter, the following must be in place for such messages:
• Restricting the audience to health professionals who have given permission to receive promotion via electronic communications
• Including obligatory information and linking to Prescribing Information and Adverse Event reporting statement
• Ensuring full certification of all proposed communications messages.
One of the Bayer tweets found in breach stated:
Sativex launched in UK for the treatment of spasticity due to Multiple Sclerosis http://tiny.cc.kiz2y
"This begs the question then around other electronic promotional messages such as those on mobile devices."
But if we ask the right key questions and know true intent, then apply the established principles and the above points, then possible promotional tweets could be suggested, such as:
Sativex?(delta-9-tetrahydrocannabinol &, cannabidiol) UK launch for spasticity due to MS http://tiny.cc.kiz2y (PI here: http://tiny.xx.xxxxx)
That's 140 characters exactly (even with that extraordinarily long non-proprietary name!).
So for those that wish to use Twitter or any other digital media, remember your Code. Mirror, signal THEN manoeuvre.
About the author:
Dr Rina Newton has 14 years industry experience in medium to big pharma working with the ABPI Code - as an originator, signatory and auditor.
She is Managing Director of CompliMed Ltd., a consultancy specialising in bespoke Compliance solutions including Code training, audit, sign-off and advice.
In what ways have you seen Twitter used as a promotional tool within the Code?
