From a European regulatory perspective, patient experience data (PED) has so far been gathered inconsistently, interpreted variably, and, in many cases, treated as supplementary rather than essential. Even the concept or definition was not universally utilized or understood. While regulators and companies have since begun to explore tools such as patient-reported outcomes, qualitative interviews, and preference studies, there has been no single expectation for how such evidence should be collected, validated, or used in regulatory and other decision-making. This meant that patient insights were too often ad hoc, narrowly sourced, or shared too late in the development process to meaningfully influence outcomes. Underrepresented communities were frequently absent and there was little transparency about how patient input shaped regulatory decisions.
The European Medicines Agency’s (EMA’s) 2025 Reflection Paper on Patient Experience Data is a formal step toward embedding PED systematically across a medicine’s lifecycle from early development through post-marketing review, signaling a recognition that lived experience is as critical to regulatory science as clinical and economic evidence, and it encourages all stakeholders to consider this type of evidence systematically. Yet, as our Lumanity Strategic Patient Council and expert contributors have observed, the proposals in the document stop short of ensuring that inclusion, accessibility, and operational clarity are built into the system from the outset.
At Lumanity, we support and practice a fully transparent, patient-led approach to innovation, so we welcome new direction from the EMA. To evaluate the paper we sought direct feedback and input from patients and subject matter experts, as we do for all our patient initiatives, including our Lumanity Strategic Patient Council who reviewed the paper and discussed its implications. While we found much to commend, we also identified opportunities to make the approach more practical, inclusive, and accessible for the people it aims to serve.
Key observations and recommended actions
Accessibility and clarity
The Reflection paper is technically comprehensive, but its dense style and heavy use of acronyms make it difficult for a lay audience, including many patients and even experienced advocates to read and engage with. As one Council member noted, “If patients can’t read it, it doesn’t count.” Such complexity could unintentionally limit the diversity of voices contributing to the conversation.
Potential action:
- Publish a plain-language companion guide co-written with patients, covering definitions, acronyms, and key concepts in multiple EU languages
- Establish a readability review as part of EMA document release akin to a “patient editorial board” that checks clarity before publication
Inclusion of underrepresented groups
Members observed that the paper does not detail how to consistently and practically ensure the perspectives of underrepresented or marginalized communities are actively sought and incorporated in the collection of PED. Without deliberate inclusion strategies, there is a risk that PED will reflect only part of the patient population. One participant summed it up simply: “I didn’t see much about underrepresented groups, and that’s quite key.”
Potential action:
- Define representation targets for PED collection (e.g., proportion of data from specific demographics or rare disease groups) and monitor progress
- Partner with community-based organizations to understand how they currently collect PED and feedback; design outreach that addresses cultural, linguistic, and logistical barriers
Practical methodological guidance
From both a patient and expert perspective, the paper’s ambition is clear, but it stops short of offering concrete methodological guidance. Researchers and stakeholders may be uncertain about what constitutes valid PED and how best to design studies, especially for newer methods such as patient preference studies. As discussed with our Council, this gap creates uncertainty and could discourage investment in PED collection. Additionally, methodologies like market research for example, that are less ‘authentically’ patient engagement, but rely on third party collection or interpretation, may not be valid from a community perspective.
Potential action:
- Develop methodological annexes detailing best practices for different PED types, patient-reported outcomes (PROs), preference studies, qualitative interviews that are co-authored by regulators, researchers, and patients
- Create a PED toolkit for sponsors, with templates, validated instruments, and case studies showing successful integration into regulatory submissions
- Offer training modules for industry and patient groups to build capacity in designing and interpreting PED studies
Supporting trust through transparency
Our discussion underscored that patients want to know how their input is used. “If you haven’t engaged patient advocates or patients from the start,” one member warned, “then actions can seem tokenistic because we haven’t been brought along on the journey.”
Without a clear feedback loop showing how PED influences decisions, even well-intentioned engagement risks feeling superficial.
Potential action:
- Introduce visible impact reporting as a public section in regulatory decision summaries explaining how PED shaped outcomes
- Use digital dashboards to provide real-time updates on PED integration during the regulatory process
- Commit to closing the loop with contributors via personalized summaries or webinars explaining decisions and next steps
Co-creation from the outset
Although the paper encourages early engagement between regulators, developers and patients, it does not set a clear expectation for true co‑creation of PED guidance and processes with patients from the very start. Without structured, ongoing patient partnership in drafting guidance, setting standards and designing PED initiatives, there is a risk that patient priorities will be secondary to technical or procedural considerations. This can result in PED frameworks that are less relevant, less trusted and less actionable, which undermines the EMA’s goal of embedding patient perspectives across the medicine lifecycle.
Potential action:
- Establish permanent patient advisory panels for EMA working groups on PED where these don’t already exist
- Run co‑design workshops before formal guidance drafting, ensuring patient priorities shape the structure and content
- Include patients as named contributors in official documentation to signal genuine partnership
“If patients can’t read it, it doesn’t count.”
– Lumanity Patient Council member
“If you haven’t engaged patient advocates or patients from the start, actions can seem tokenistic because we haven’t been brought along on the journey.”
– Lumanity Patient Council member
“I didn’t see much about underrepresented groups, and that’s key.”
– Lumanity Patient Council member
Shared perspective: Patients and experts
Our Patient Council saw five priority areas for strengthening the EMA’s approach:
Opportunities ahead
The Reflection paper is a strong foundation. Building on it could involve:
- Publishing a plain-language companion guide co-written with patients
- Adding methodological annexes for PROs, patient preference studies, and qualitative engagement data
- Embedding inclusion strategies into PED requirements
- Leveraging technology and artificial intelligence (AI) to reduce burden and improve quality
- Creating transparent, public feedback mechanisms so contributors see the outcome of their input
Thoughts and reflections
While the EMA guidance is an important recognition of the value and need for PED, there is a risk that patient experience data will be collected, but not fully trusted, understood, or acted upon. The EMA’s Reflection Paper is a strong foundation, but unless it is refined in partnership with patients to be accessible, inclusive, and operational, its transformative potential will not be optimized.
We appreciate the EMA’s commitment to bringing patient perspectives into the heart of regulatory science. As one Council member reflected, “It’s good they’re asking for feedback, but if patients can’t easily read or understand the paper, how can they give it?” By working in partnership with patients to refine the approach, making it more accessible, inclusive, and operational, the EMA can help ensure that PED truly reflects the breadth and depth of patient experience, and that it delivers on its potential to improve health outcomes across Europe.
“It’s good they’re asking for feedback, but if patients can’t easily read or understand the paper, how can they give it?”
– Lumanity Patient Council member
