Patient support programmes feature prominently across the PCC agenda through sessions focused on commercial risk, patient engagement, and programme design. As healthcare systems continue to shift toward more patient-centric and outcomes-driven models, these programmes are expanding in both scope and strategic importance. With that expansion comes heightened compliance complexity and regulatory attention.

Patient support initiatives rarely sit neatly within a single function. Instead, they operate at the intersection of promotion, access, data privacy, pharmacovigilance, and ethics. Programmes may include financial assistance, adherence support, disease education, or digital tools that collect and analyse patient data. Each of these elements introduces distinct regulatory considerations and the combined effect can create risk if governance and oversight are not carefully aligned.

For compliance teams, the challenge is not whether patient support programmes should exist, but how they can be designed and operated in a way that genuinely benefits patients while remaining compliant with evolving expectations around transparency, intent, and appropriate influence.

Why this matters now

• Patient-centric and value-based care models are accelerating, increasing reliance on support programmes as part of broader healthcare strategies
• Digital tools and data-driven solutions are becoming central to programme delivery, raising complex questions around consent, privacy, and data use
• Regulators are paying closer attention to patient-facing initiatives, scrutinising both how programmes are structured and how their intent can be demonstrated

In this environment, even well-intentioned programmes can attract regulatory or reputational risk if they are perceived as promotional in nature or insufficiently governed.

The value for PCC attendees

PCC sessions and community discussions provide compliance leaders with practical insight into how peers are approaching these challenges. Through case studies and shared experiences, attendees can explore how organisations are structuring governance models, defining roles and responsibilities, and embedding compliance considerations early in programme design.

These conversations reinforce the importance of strong cross-functional collaboration between compliance, legal, medical, commercial, and data privacy teams. Rather than acting as a final checkpoint, compliance is increasingly expected to be a strategic partner helping shape programmes that are defensible, transparent, and aligned with both regulatory expectations and patient needs.

For PCC attendees, this translates into concrete takeaways on how to:

• Establish clear governance frameworks for patient support programmes
• Assess and document programme intent in a defensible way
• Balance innovation and patient benefit with regulatory and ethical obligations

As patient support programmes continue to evolve, compliance leaders must ensure they remain a source of trust rather than risk. PCC offers a valuable forum to learn how organisations are doing just that in a rapidly changing, patient-centric landscape.