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Giving Patients a Stronger Voice: EMA’s New Reflection Paper on Patient Experience Data

On 29 September 2025, the European Medicines Agency (EMA) published a draft reflection paper inviting public comment until 31 January 2026. Its aim? To better integrate the lived experience of patients into how medicines are developed, evaluated, and regulated. 

What is Patient Experience Data

“Patient experience data” refers to information that directly reflects what matters to patients: their experiences, preferences, outcomes they care about, even trade-offs they are willing to make—in their own words or through structured methods. Crucially, this excludes interpretation by clinicians or others. 

Such data can be:

  • Qualitative: interviews, focus groups etc., exploring what impacts quality of life, what side effects patients fear or find acceptable.

  • Quantitative: patient preference studies (PPSs), patient-reported outcome measures (PROs), etc. 

Why This Matters

The EMA emphasizes that patient experience data complements—but does not replace—traditional clinical outcomes and scientific data. It offers insight into:

  • What patients value: e.g. in cancer treatments, not just how long life is extended, but how good that additional life is. 

  • Which side effects or quality-of-life aspects patients might accept.

  • How to design trials, post-market surveillance, and regulatory decisions in a way that better aligns with real patient priorities. 

What the Reflection Paper Suggests

The paper has several key proposals and guiding principles:

  1. Lifecycle inclusion
    Patient experience data should be collected and used at all major stages: pre-authorisation (during development), benefit-risk assessment, and post-authorisation. 

  2. Data sources
    Possible sources include clinical trials (with patient-reported outcomes), real-world data (including safety surveillance), patient preference studies, mobile health technologies, social media, etc. Some of these are well-established; others are emerging or less validated. 

  3. Methodology
    While the paper stops short of detailed technical guidelines, it lays out general principles for how to generate, collect and analyse patient experience data. It also indicates that EMA is coordinating with the International Council for Harmonisation (ICH) to harmonise methodology globally. 

  4. Engagement & advice
    EMA already offers platforms like scientific advice and qualification of novel methodologies, which developers can use to get early feedback on plans for collecting patient experience data.

What’s Next: Public Consultation & Shaping the Future

The draft is open for public comment until 31 January 2026. Stakeholders—including patient groups, researchers, medicine developers—are encouraged to use the template provided by EMA to submit feedback. 

The input will be used to refine how patient experience data is used in EU medicine regulation. The goal is to ensure evidence generation focuses on outcomes that matter most to patients, not only what scientists or regulators assume matters. 

Reflections & Implications

Here are some thoughts on what this might mean, and what challenges or opportunities lie ahead:

  • Better alignment: If patient experience data becomes more systematically used, drug development and regulation may better reflect real-world trade-offs, improving patient satisfaction and relevance of therapies.

  • Methodological hurdles: For less established sources (e.g. social media, mobile health), there are questions about validity, bias, representativeness, privacy, and how to standardise collection. Also the regulatory weight such data will carry needs clarity.

  • Resource implications: Gathering patient experience data (especially qualitative work, preference studies) takes time, cost, and expertise. Smaller developers may need support.

  • Ethical & transparency considerations: Who defines what’s “important” to patients? How are patients selected, how is data handled, and how are results shared? Ensuring inclusion (age, socio-economic, geographic diversity) will matter.

  • Global harmonisation: Working with ICH suggests a move towards common standards, which could reduce duplication and improve cross-border consistency. Useful for industry and regulators alike.

What to Watch

  • The final version of the reflection paper after the consultation period.

  • Any EMA or EU guidance documents giving more detailed methodological standards.

  • How regulators in other jurisdictions (US FDA, other health authorities) respond or adapt similar patient-experience data policies.

  • Whether medicine developers start reporting more on what patients say is most important in their drug submissions (not just standard safety/efficacy).

Conclusion

This reflection paper is a promising step toward making regulation of medicines more patient-centred. It acknowledges that the voices and experiences of people with lived experience should count not just in principle, but in the actual design, evaluation, and monitoring of treatments. The challenge now is in ensuring that this is done robustly, inclusively, and meaningfully.

At Regvista, we remain committed to support biopharmaceutical leaders navigating their transformative journey—bringing cutting-edge therapies to market faster and safer.