Tired teams, last-minute campaigns, and a swirl of regulatory updates — the Christmas run-up in pharma is always a mixing pot of reflection and resolve. Reflecting on this year's ABPI Code breaches, I’ve noticed a recurring theme: many slip-ups stem not from malice, but from misunderstanding how the Code interprets communication. Let’s unpack what 2025 has really taught us about compliance, and how we can enter 2026 with clearer, rather than quieter, communication strategies.
Festive reflection: The year through a pragmatic lens
As the year draws to a close, I see pharma teams across the UK and EU pausing to review their ABPI Code and PMCPA compliance outcomes. There’s a collective sense of fatigue—understandable after months of navigating complex regulations and high expectations. Yet, beneath that tiredness, there’s also genuine engagement and a willingness to learn from what worked (and what didn’t).
What stands out in 2025 is that most pharma compliance breaches weren’t the result of bad actors or reckless behaviour. Instead, they stemmed from well-meaning teams who misjudged how their materials might be perceived. The emotional toll of this can’t be underestimated, especially when teams are doing their best under pressure. It’s a reminder that compliance is less about policing and more about guiding—especially when the year-end rush tests our focus.
Many colleagues tell me they feel the weight of responsibility, balancing festive deadlines with the need for clarity and defensible decision-making. The reality is, the ABPI Code isn’t a barrier—it’s a framework that helps us communicate with confidence and integrity, even when the stakes are high. As we reflect, let’s acknowledge the effort, empathy, and professionalism that define our industry at its best.
The big misconception: Non-Promotional isn’t low-risk
Every December, I see the same myth resurface: that non-promotional materials—disease awareness campaigns, patient support tools, or educational content—are somehow “safe zones” in pharma marketing. This year’s PMCPA cases tell a different story. In fact, non-promotional materials have become a major source of complaints, often due to how they’re perceived rather than what was intended.
Why the shift? Regulatory scrutiny has intensified. Both the ABPI Code and EFPIA updates now spotlight disease awareness and patient support materials, especially when they echo therapeutic indications or subtly align with brand imagery. The 2024-25 period saw several high-profile breaches where educational content was judged as indirect pharmaceutical advertising—despite teams’ best intentions. One case involved a disease awareness leaflet that, through its imagery and language, was seen as crossing the line into promotion.
It’s a clear reminder: under the ABPI Code, perception trumps intention. As I often say,
‘Non-promotional content under the Code can disguise promotional intent if not carefully crafted.’ – AskAnzal
With VPAG payment rates for branded medicines rising to 22.9% in 2025, the pressure to deliver value is real—but shortcuts in compliance aren’t the answer. The safest route? Treat non-promotional materials with the same rigour as overt advertising, and document your rationale at every step.
Perception over Intention: How the ABPI Code sees is
One of the most persistent myths in pharma compliance is that good intentions protect you from PMCPA breaches. In reality, the ABPI Code is rooted in perception-based compliance. As I often remind teams,
‘The Code judges the message through the eyes of those receiving it, not those sending it.’ – AskAnzal
PMCPA decisions consistently hinge on how a ‘reasonable reader’—not a marketer, not a medic—would interpret your content. This means that even the most well-intended disease awareness campaign or patient material can fall foul if it’s perceived as promotional or misleading. This year, we saw several cases where teams documented their rationale and intentions, but the outcome was dictated by how the content landed with its audience.
Understanding real-world interpretation is now central to pharma compliance. It’s not enough to say, “We meant well.” Instead, ask: “How might this be perceived by a healthcare professional, patient, or the public?”
To reduce risk, teams should predict likely interpretations and document their thinking—ideally at pre-certification. This approach doesn’t just protect against PMCPA breaches; it builds a defensible case for your communication. In the end, perception-based enforcement isn’t about stifling creativity—it’s about ensuring our messages are clear, ethical, and trustworthy in the eyes of those who matter most.
Three practical lessons from 2024: Non-Promotional ≠ Low Risk
This year, PMCPA breaches have made one thing crystal clear: non-promotional does not mean zero risk. In fact, non-promotional, educational, and disease awareness activities are now under sharper scrutiny than ever. Pharma compliance teams can no longer assume that “safe” equals “silent”—the risk assessment must be just as rigorous as for overt promotional work.
First, the misconception that non-promotional equals low risk is outdated. The PMCPA’s faster abridged procedures in 2024 have increased the pressure, catching teams off guard when documentation or clarity is lacking. Risk assessment in pharma must be vigilant, regardless of the label attached to the material.
Second, over-caution is not compliance. I often remind teams:
‘Being overly cautious can ironically increase compliance risk—it’s a balance, not a shutdown.’ – AskAnzal
Silence or inaction can stifle ethical, necessary communication and even undermine trust.
Third, documentation and rationale are your best defense. When challenged, a clear audit trail and well-reasoned justification for decisions consistently outperform defensiveness or reticence. In pharma, robust documentation in job bags is not just a box-tick—it’s the foundation of defensible compliance.
2025’s breaches have shown that the real risk lies in misunderstanding perception and neglecting to document the “why.” As we look ahead, let’s remember: clarity and rationale are our strongest shields.
Reframing the Code: From chokehold to shield
It’s easy to see the ABPI Code as a set of handcuffs—especially after a year of high-profile breaches and nervous compliance meetings. But let’s be clear: the Code isn’t here to silence pharma. Its true purpose is to uphold transparency in pharma, foster trust, and protect both patients and our industry’s reputation. As I often remind teams,
‘Think of the Code as a shield protecting both patients and pharma’s reputation—not a cage to restrict action.’ – AskAnzal
Good signatories don’t just spot risks—they empower colleagues to communicate clearly and defensibly. The Code, when understood and applied pragmatically, enables ethical pharmaceutical advertising and strengthens brand protection through balanced, substantiated messaging. It’s about ensuring that every piece of pharma marketing or medical content stands up to scrutiny—not by being silent, but by being transparent and fair.
Industry standards are evolving. The expectation is not for teams to retreat into silence, but to document their rationale, show fair presentation, and maintain safety context. Balanced pharma communications, aligned with the Code’s focus on substantiation, are not just compliant—they’re credible. The real win is when the Code becomes a tool for enabling ethical marketing, not a barrier to meaningful engagement.
The 2026 mindset shift: from ‘Is it Allowed?’ to ‘Can I Defend It?’
As we look ahead to 2026, it’s time for a fundamental shift in our compliance mindset. For too long, pharma marketing compliance has been dominated by the question, “Is it allowed?”—a permission-based approach that often leads to unnecessary silence or over-cautious decisions. But evolving ABPI Code enforcement and real-time scrutiny demand more than just ticking boxes; they require confident, defensible communication backed by clear documentation.
Instead of defaulting to risk aversion, I encourage teams to ask: “Could we confidently defend this if challenged?” This isn’t about pushing boundaries for the sake of it—it’s about building a culture where transparency, rationale, and robust audit trails underpin every communication strategy. When we focus on the ‘why’ behind our decisions, we not only improve risk assessment but also strengthen our position if challenged by the PMCPA or internal audit.
‘The real question isn’t ‘Is it allowed?’ but ‘Would I stand by this if challenged tomorrow?’’ – AskAnzal
This mindset shift is a practical tool for senior signatories and compliance teams. It moves us from reactive caution to proactive, documented decision-making—enabling us to use the ABPI Code as a shield for good practice, not a muzzle. In 2026, let’s champion defensible communication and clarity over silence.
Final thought: Starting 2026 Clearer, not Quieter
As we wrap up another year under the ABPI Code, it’s worth pausing to reflect on what these breaches have truly taught us. The lesson isn’t to retreat into silence or play it safe by default. Instead, the real opportunity lies in integrating these learnings to empower clearer, more confident pharma communication. The Code—often miscast as a hurdle—is, in reality, our industry’s shield: it protects not just companies, but the trust we build with patients and healthcare professionals.
‘Clear communication backed by confident compliance is the best gift pharma can give its stakeholders.’ – AskAnzal
Let’s carry this mindset into 2026. Rather than asking, “Is this allowed?” let’s challenge ourselves with, “Can we defend this, transparently and confidently, if questioned?” This is the heart of perception-based compliance and the future of pharma communication.
I’ll be exploring how to apply this thinking practically—in real job bags and everyday scenarios—in upcoming posts. For now, take a moment to celebrate the progress you and your teams have made. Enter the new year with clarity, not caution. The ABPI Code is here to guide, not silence.
Wishing you a festive, forward-looking close to the year.
AskAnzal