series of global forums convened in recent months across Europe and Asia (see details at end of article) have surfaced a remarkably consistent signal about the future of patient engagement (PE) and patient experience data (PED): Regulators, patient organizations, and industry leaders across geographies and health systems are no longer debating whether PE and PED matter. The conversation has shifted decisively to how—and how quickly—they can be embedded into decision-making in a credible, systematic way.

Despite differences in context and maturity, discussions in Bucharest, Dublin, London, and Tokyo converged on a shared understanding: PE and PED are becoming foundational to how healthcare learns, prioritizes, and improves. As one Japanese participant put it, they are “two wheels of the same car”: a Japanese expression which infers that without both, the system does not move forward.

Taken together, these conversations point to a field at an inflection point: Expectations are rising, regulatory and HTA interest is increasing, and yet operational capacity is struggling to keep pace. This tension is shaping the next phase of PE and PED globally.

Rising Expectations, Limited Infrastructure

Across all four forums, one message was clear: Symbolic or ad hoc patient involvement is no longer sufficient. Expectations have evolved rapidly.

Governments, regulators, HTA bodies, and healthcare developers increasingly expect patients to act as co-leaders rather than participants; co-design to be standard practice rather than a test case; lived experience to influence outcomes rather than simply validate them; and PED to function as strategic evidence rather than anecdotal input.

At the same time, a persistent gap remains between ambition and capability. Many systems expect patient organizations to operate as professional actors without providing them with commensurate investment or infrastructure. There is broad recognition that while expectations have advanced, the mechanisms needed to support early, diverse, sustained engagement have not.

The ambition is widely shared. What is missing is the scaffolding required to implement it.

Collaboration Is Unavoidable — and Often Misdesigned

Collaboration featured prominently in every discussion, and for good reason. PE and PED only generate value when multiple actors work together across the lifecycle of medicines and health technologies. However, it also became clear that traditional models of collaboration (such as siloed, fragmented data collection and sharing; physician-centered, hierarchical decision-making, etc.) are under strain and are not delivering.

Stakeholders consistently called for:

1. Pre-competitive spaces that elevate disease-level insight over product-specific concerns
2. Shared standards across regions and regulatory and HTA agencies to reduce duplication of effort and burden on the patient community
3. Mechanisms for coordinated rather than fragmented investment in the generation and use of PED
4. Structured dialogue with the patient community that goes beyond consultation and progresses towards sustainable partnerships
5. Feedback loops between regulators/HTAs, sponsors, and the patient community that meaningfully close and communicate if, how, and when PED was used for decision-making.

The way collaboration is currently designed is not meaningful or sustainable. Participants highlighted the need to move away from one-way, last-minute request-driven engagement toward co-creative approaches, where ownership of insight and responsibility for interpreting and applying it in decision-making are shared. Increasingly, collaboration is viewed not as a superficial reputational consideration, but as a practical and valuable necessity for managing the complexity that PE and PED introduce into decision-making.

Operationalization Remains the Shared Bottleneck

Perhaps the most consistent — and quietly acknowledged — theme across geographies was operationalization. There is broad agreement on what “good” patient engagement looks like in principle. The seven Patient Engagement Quality Criteria (which were co-created from existing patient engagement frameworks and from the PFMD multi-stakeholder co-creation work stream) describe the core values that a good PE practice should consider including in its processes.

What remains uneven is the ability to deliver it at scale.

Common barriers surfaced repeatedly:

1. Duplication of studies and frameworks between and within companies and the asks to patient organizations. This creates an unnecessary burden on patients and patient organizations, which may lead to decreased capacity to participate in future PED-generation activities.
2. Limited consensus from regulatory and HTA bodies on what constitutes high-quality PED, leading to uncertainty and lack of motivation from sponsors to invest in these studies. Without clear guidance, sponsors may deprioritize PED generation, which slows the integration of meaningful patient insights into regulatory submissions and HTA evaluations.
3. Weak integration of lived experience into regulatory and HTA timelines; some agencies have good systems in place, while others are less mature (e.g., FDA has established Patient-Focused Drug Development meetings, whereas some regional HTAs have ad hoc processes). This uneven integration limits the impact of PE on decision-making and can reduce the relevance and timeliness of PED in shaping product development or approval.
4. Lack of validated metrics to assess impact of PED on regulatory decision-making. Without standardized measures, it is difficult to demonstrate the value of patient input and PED, which undermines efforts to embed PE systematically into product lifecycle decisions.
5. Insufficient institutional capacity within patient organizations to meet the requests from sponsors to support PED generation and use. This constrains both the quantity and quality of collected PED, potentially biasing data toward more resource-rich organizations and leaving other patient voices unheard.
6. Minimal feedback to patients on whether and how their engagement influenced decisions (either positively or negatively) from regulatory and HTA bodies and industry, leading to disengagement over time. Lack of transparent communication reduces trust and the willingness of patients to invest time in future PE activities, weakening the sustainability of PED initiatives.

The field has reached a point where knowledge and intent are high, but execution remains inconsistent. Without operational clarity, PE and PED risk remaining rhetorically valued but variably applied in practice.

This inflection point is increasingly visible beyond the patient engagement community itself. A recent British Medical Journal editorial, responding to the World Health Assembly resolution on social participation, makes clear that participation is a system responsibility—one that requires governance, resourcing, and accountability—rather than an expectation placed on patients or individual champions.

The editorial signals a broader shift: Health systems, regulators, and funders are now expected to act. This mirrors what surfaced consistently across the four events — that PE and PED have outgrown informal, project-based approaches and now require deliberate, structural solutions.

Engagement as Infrastructure

Beneath these practical challenges lies a deeper shift: Across conversations, PE and PED are moving from being treated as transactional inputs toward being recognized as core system functions.

The focus is shifting from collecting perspectives to shaping shared understanding; from asking where patients can be involved to examining where patients should lead. This reframes engagement as infrastructure: continuous, embedded, and central to legitimacy and trust in healthcare decisions.

Such a shift requires PE and PED to be treated as shared system responsibilities rather than delegated tasks, and as sustained dialogue rather than episodic engagement.

What This Means for Health Systems Now

Taken together, these global conversations point to several implications for the next phase of PE and PED.

• First, infrastructure matters. If patient organizations are expected to function as system partners, they must be funded and equipped accordingly. This includes predictable, long-term funding for patient organizations; access to methodological, legal, and data expertise; shared platforms for PED generation and reuse; and formalized roles for patient leaders within regulatory, HTA, and development processes, rather than reliance on project-by-project participation or goodwill.
• Second, collaboration requires redesign. Across every forum, disease-centered, longstanding multistakeholder structures were consistently identified as more effective than one-off consultations. This means shifting from episodic engagement toward longstanding disease-centred, multistakeholder structures with clear governance, shared agendas, and defined decision interfaces which enable patient insight and PED to be generated once, stewarded collectively, and applied across multiple decision points.
• Third, quality must be clarified. Shared, transparent criteria for high-quality PE and PED are essential to enable confident use across contexts.
• Fourth, capacity building is crucial. Leadership development, data literacy, and organizational support are prerequisites for meaningful participation.
• Finally, the shared identification and definition of meaningful experience must be recognized as core evidence work. Structured interpretation of lived experience underpins both the legitimacy and utility of PE and PED.

Converging Direction of Travel

Across regions, stakeholders appear aligned on the direction of travel, even if they are at different stages of readiness. Patients are recognized as co-architects of the systems that evidence informs.

The defining questions for the next phase are whether systems will build the structures required to sustain this shift and allow it to deliver on its promise. Whether PE and PED become embedded infrastructure or remain dependent on individual champions and isolated initiatives in regulatory and HTA guidance, in how decision-making processes are designed, and in whether patient insight is consistently resourced, governed, and fed back into outcomes, will determine whether the current moment marks genuine system change or another cycle of unrealized potential.