Code Clarity

Competence is not just about job titles. Rina & Jean discuss why real skills and practical experience remain essential to understanding the INTENT behind the Code to applying JUDGEMENT in complex approval scenarios. The Code Clarity Final Signatory & AQP Collections are available now.

In this episode, Rina and Jean discuss what happens when senior global leaders speak about medicines in UK national media - and why even well-intentioned interviews can cross into promotion of prescription-only medicines to the public. (Full cases here: 0277 & 0518 )The takeaway is surprisingly simple. Only 3 minutes for our ONE top tip.

Patient stories are powerful and that’s exactly why pharma want to use them. In this episode, Rina and Jean analyse three AstraZeneca videos that used patient testimony describing treatment as “the best”, and why that language ultimately led to PMCPA breaches. A must-listen for anyone approving patient-facing or patient-led materials under the ABPI Code.(Case/0360/11/24 & /0355/11/24 & /0377/11/24)

In this episode, Rina and Jean dissect the new PMCPA social media guidance and highlight three key changes that add clarity for pharma companies. Essential listening for anyone signing off or posting pharma content online.

The PMCPA has published 14 page guidance on Package Deals. We cut through the fluff and tell you what you need to know & why reviewing existing arrangements now matters for compliance and transparency.

Can a venue name alone imply excess? Rina and Jean unpack a recent case (Case/0440/01/25) where a meeting held at a “beach hotel” was perceived as lavish. They discuss how optics, assumptions, and language can affect judgment, and why facts still matter most in compliance decisions.

As MLR queues grow, complexity increases & review pain/boredom set in...there's good news for everyone! Rina & Jean are joined by Harry Bliss & Dan Bentley from Siguru to discuss how AI can help approval teams move from bottleneck to breakthrough, without compromising compliance. To find out more about AI-enabled MLR support, visit www.siguru.ai

Rina and Jean look ahead to UK pharma compliance in 2026, including likely complaint hotspots, familiar risk areas and the big question of PMCPA modernisation.

Two recent PMCPA cases (0273 & 3882) highlight a surprisingly simple point: using images that don’t reflect real patients doesn’t automatically mean a breach. We unpack what the rulings tell us about context, accuracy and visual representation in pharma comms - and why it matters for your next campaign. Images can be seen here.

When is a medicine… not a medicine — at least according to the PMCPA? 🤔In this episode, we dig into a fascinating case (AUTH/3880/2/24) where the ruling found no promotion of a medicine on social media. What crossed the line, what didn’t and what does it mean for your next post?

Speakers confirmed, slides ready… but no one shows up. 😬What do you do when a pharma meeting has no audience? Cancel? Pay? Re-run? We chat through compliance, optics and common-sense calls in this scenario.

The PMCPA says (currently) most complaints still stem from social media - and they’re now hinting at a cease-and-desist approach. We unpack what that could mean for pharma whilst everyone is still guessing what “promotional” really means...

It seems the PMCPA's review on defining Medical Education is freezing up ❄️. With the PMCPA’s influence possibly shaping European guidance, and post-Brexit UK now charting its own stricter course, is this the moment to rethink how “medical education” and “promotion” are defined, and what it means for pharma on both sides of the Channel?

Declarations of involvement are causing drama! But they are an easy target which means a quick win for pharma too. We discuss the 5 point-plan the PMCPA don't want you to know - more of this at our conference.

Two PMCPA rulings (one old, one recent) about an "innocent" drink but involving pharma customers. A casual thank-you or a full-blown breach?Our conference on 4 Nov will discuss commercial push, medical pull and compliance risks.

SOME say UK pharma has “a slow self-regulatory process that fails to ensure compliance” (BMJ letter, Oct 23)WE say it is the PMCPA themselves bringing the industry into disrepute (evidence to be presented at conference)🛠️What do YOU say? Does self-regulation need fixing?🎤 Join the conference debate

Another day, another email & another PMCPA case. Can we blame Brexit for Global forgetting the UK is no longer in the EU? Can 21 emails in 3 months ever not be spam? We'll explore how medical publishers can get ahead of pharma's needs. (Case Auth/3860/12/23, 3862/12/23, 3866/12/23 & 3889/4/24)

Waiting for the PMCPA to audit your company? In this episode, we unpack why proactive compliance audits beat reactive panic, how they foster a healthy culture, and how to turn findings into solid CAPAs - not just a pile of paperwork!

It’s the detail that matters. Moderna skips over the nitty-gritty and the Appeal Board isn’t having any of it. Rina & Jean look at what happens when you serve generalities instead of granularity. (Case AUTH/0316/10/24 & 3835/10/23.)(3/3)

Moderna responds to a PMCPA complaint... but forgets one crucial ingredient: *all the details*. We explore why being “not-so-full and not-so-frank” came back to bite and led to an audit. (Case AUTH/0316/10/24.) (2/3)

Can a “views are my own” disclaimer really save you from the PMCPA’s watchful eye? Spoiler: no. Moderna learns this the hard way. (Case Auth/ 3835/10/23) (1/3)

Rina & Jean dive into the drama of a recent confession by Pierre Fabre & the results of our audience poll... asking the big question: should voluntary admissions come with a checklist… or at least a decent apology template?

The ABPI has recently published guidance on congresses. What does the Code already say on this topic? What does the Guidance include? And what does it all mean. Code Clarity is hosting a webinar on this topic on 6th May 2025, 12.30-1.30pm. Contact us at [email protected] for more details.

Jean and Rina discuss a recent case about something said by a Celltrion sales rep - top tips relate to why it's important to prove what you say in calls is correct!

Our poll suggests 85% of you want the QR code to link to SPC OR for HCPs to refer to the SPC. So is this the beginning of the end for Prescribing Information?

A recent case about a gay dating app confirms WHEN the UK Code applies and WHY appeals are worth it.

Yay, a Complaints Masterclass to increase your confidence when it comes to self-regulation - from experts in complaints management! Register your interest: [email protected] (15th May 2025, 1.30-4.30pm, Woburn House, London, WC1H 9HQ)

An update on case rulings that may affect the way UK Pharma can do Medical Education - what's changed and what can we learn? Cases discussed are AUTH/3832/10/23 and AUTH/3825/9/23

Recent news about Astellas merging C-suite roles (medical and commercial) - what's the fuss about? And top tips if you're considering the same.

Rina & Jean discuss a recent appeal by Janssen relating to UK speakers presenting at international meetings - why was the appeal so good?!

Becs Shuttleworth joins Rina & Jean to explain the importance of bringing compliance into the light.

Yay the first abridged procedure case vs CSL Seqirus has been published! A dull case but Rina covers the 2 interesting points to take away

Oh dear - an employee of a competitor company lobs a rubbish complaint to the PMCPA and wow - they have to accept, as it's non-contactable. MADNESS.

How to influence Code changes (yes it can be done!) & tips about the practical implementation of QR Codes with Jenni Harrison and Richard Blackwell. If you need confidence, here's a link to our compliance checklist on QR codes.

Pharma supporting HCPs to attend meetings - Code vs PMCPA guidance vs our thoughts on the simple ways to achieve compliance.

Why were there so many breaches about CLAIMS in 2024? W2 discuss our 3 top tips to help you tackle this risk.

A painful PMCPA press release but our 3 minute takeaway to simplify matters.

It's no surprise who the "winner" is here, but Rina & Jean discuss the many factors involved in what makes a BIG case.

...errr...don't mention product. A recent breach for AbbVie and our advice on common sense.

Rina chats to Dr Tim Ringrose (CEO, Cognitant) about empowering patients with long-term conditions with digital tools, and how his workshop at this year's Code Clarity conference will focus on this and positive case studies.

Rina & Jean dissect the key highlights from the latest PMCPA report - what does it really tell us about their finances...

Lawyers and the ABPI Code - responding to complaints, writing up case rulings, ruling on cases - our honest thoughts.

Everyone's worried about possible complaints if they use AI in MLR/copy approval. Rina & Jean discuss the likely scenarios and spolier alert - it's not that bad.

OF COURSE this week's podcast is about the newly published ABPI Code 2024.In a surprise twist that shocked even them, find out what Rina & Jean love (strongly like) about the Code updates and why. For more info, do join our 10 Oct webinar!

Why is it so hard for the public to make a complaint to the PMCPA? We discuss a recent case* and constructive ways this could be made much easier, clearer and fairer. *Case AUTH/3717/12/22 See S2 E12 for top tips to make a complaint if you're in pharma.

We chat about the most common compliance concern expressed to us about AI: "AI will never be error-free!". Join us at this year's conference for a workshop on the "Practical Appliations of GenAI in Pharma".

After a great summer, Jean and Rina recommend some books* and discuss how a quote resonated strongly with Code Clarity's vision around digitalising compliance confidence for the many. * Stolen Focus / The Almanack of Naval Ravikant

Rina & Jean are back from their Tenerife pool parties and their last S2 podcast discusses their predictions for the new ABPI Code 2024 and changes at the PMCPA… Tune in again in Sept to see if any turn out to be right! But in the meantime thank you for listening and enjoy your summers ☀️

A new pharma employee asked us about using LinkedIn - hear our advice or access our checklist.

Rina discusses a recent complaint vs GSK - it did not breach the Code but WHY? Jean asks all the questions a good signatory should be considering based on our checklist. See Code Clarity's LinkedIn page to see a similar TV ad.