Cracking the ABPI Code of Practice: What changes could be coming your way?
Hold on to your hats – updates to the 2021 ABPI Code of Practice have been suggested. But what are the proposed changes, and what do they mean for digital communications in healthcare?
6 mins | 31/01/2024Key takeaways
- Pharmaceutical companies and their agencies may be required to have robust policies and standard operating procedures (SOPs) for compliance
- A proposed abridged complaints procedure would allow companies to halve their admin costs if they accept a breach
- QR codes for links to prescribing information on printed materials may soon be in vogue
- Black triangle placement could be changing – will it be needed at first mention of a drug name, or most prominent?
Introduction
The ABPI Code of Practice sets out the rules and regulations for how the pharma industry can maintain high standards. It’s something AMP27 always keeps in mind when producing content for our clients, but which of the suggested updates will impact our day-to-day work the most?
Below are a chosen few that I’ll be keeping on my radar as Senior Editor for AMP27.
High standards for employees, companies, and third-party providers
As an agency that teams up with some of the biggest pharma companies around, making sure we follow their policies and standard operating procedures (SOPs) is a way for us to establish a great working relationship.
The proposed updates to Clause 5.1 and 5.2 of the ABPI Code of Practice specify ‘the requirement to have robust policies and SOPs which include corporate standards, expectations and behaviours, and training… It also incorporates company responsibility for third-party providers and those retained by way of contract’.
Internally, AMP27 has SOPs, training, and best practice examples in place to cover all aspects of our work, but how can we ensure that our clients have these set up too? Early and open discussions about SOPs and expectations of employees (both internal and external) will continue to be part of our project kick-offs. As always, we’ll have to ensure our teams have carried out necessary client training, maintaining the high standards we’re all aiming for.
Abridged complaints procedure
Although no company wants to have to go through the ordeal of having a complaint made against them, you still have to be prepared. As compliance experts, we work with our clients to make sure they can defy the norm without breaching the code. That’s why we’d have to know all about the suggested abridged version of the complaints procedure – even if our goal is to never experience it first-hand!
The change would mean that in the more open and shut cases, and those without multiple allegations, a quicker (and cheaper) resolution would be on the table. The respondent company would accept the breach, submit in writing that it won’t happen again, and look into their compliance processes to make sure there’s no possibility of a repeat offence.
There would be no right of appeal by either the complainant or the respondent company, but the administrative charges that the company has to pay would only be half of what a full complaints procedure costs.
It does make me wonder – will companies accept breaches that they may previously have fought, in order to have the matter resolved in a reduced timeline and at a reduced cost? It’ll be interesting to see what qualifies as an ‘open and shut’ case, and what the limits are to the abridged procedure.
QR codes
A general review of Clause 12 has been carried out in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA), and the use of QR codes is in for a bit of a shake-up.
In short – QR codes on printed items are in. It used to be that on printed items you’d need to include the abbreviated prescribing information (PI), which can still be pretty hefty and doesn’t give your ad that sleek look you might have been going for. The change wouldn’t apply to online PDFs, only digital materials that are intended to be downloaded and printed out.
This gives us a little hint that the ABPI are moving to keep up with audiences that are increasingly focused on digital, something we’ve noticed the code has lagged behind on in online and social spaces.
This change will still make things easier when the occasion arises though – recently we produced a printed advert for a client and had to include an abbreviated PI for both Great Britain and Northern Ireland. Not an easy thing to do when you need to have all your ad copy alongside an eye-catching design! Linking to a full PI using a QR code will make our designers’ lives a lot easier.
Black triangle guidance
You’d think that such a small symbol wouldn’t cause sleepless nights for medical editors, but you’d be wrong. Previous ABPI guidance for medicines under additional monitoring was that a black equilateral triangle had to be placed at the first or most prominent mention of the drug name. The suggested change to Clause 12.8 of the ABPI Code of Practice would mean that the triangle has to be featured next to the most prominent name on digital items, not at first mention.
This may seem like a small update, but when working on digital items it can be a bit trickier than that. Take an email for example – the first mention could technically be in the subject line, and the most prominent mention could be in the email banner image.
At AMP27, we would never use the black triangle in only the email banner. What if the banner doesn’t load for the recipient? Do we want to risk being non-compliant due to an image not loading?
If the update is approved, it seems the simplest way to ensure we maintain high standards is to follow the guidance of having the black triangle next to the most prominent drug name, but to also place it at first mention within the body copy. It’s better to be safe than sorry!
Not sure if your content is compliant? Reach out to AMP27 today for a free consultation call!
Contact usSo, what’s still needed?
Working as an editor with AMP27, I see a lot of social media campaigns go out our door. Over the past 10 years, the ABPI and PMCPA have been playing catch-up with digital marketing for HCPs and how to make sure it's compliant. It was only in January 2023 that the PMCPA released their Social Media Guidance, nearly 20 years after Facebook and LinkedIn launched.
Big changes are happening across the healthcare industry when it comes to online interactions. YouTube's recent addition of an HCP account verification tag, the predicted growth of Instagram's Threads, and LinkedIn's brand partnership tags are all changing how the pharma industry works with online platforms.
At AMP27, we've been pushing the boundaries in digital communications for seven years. In that time, we've developed great relationships with compliance experts both internally and externally. It's helped us to deliver differently for our clients and maximise the impact their communications can make. However, we're eager to get more clarity from the ABPI. We can only cross our fingers and hope that the 2024 Code is the next move towards our industry understanding digital better!
Update: The new 2024 ABPI Code of Practice has been released! After a nine-month wait, the updated guidance is finally here – see what's changed, and what it means for your marketing materials!
