Defining patient-centricity and its influence at EU level

Until the last few years, health technology assessments (HTAs) were focused on the measurement of clinical effects, rather than the assessment of the impact of different outcomes on users’ perceived value. Now, increasingly, patient experience is becoming a valuable source of information to inform clinical and regulatory decision-makers.

“HTA is not a mere research tool, but rather a systematic, rigorous, reproducible assessment process that can be considered a bridge between the world of research and the world of decision making, particularly policy making” [1]

This article is the first of a three-part series on burgeoning patient involvement in formal regulatory and clinical assessments. To kick-off, let’s explore the purpose of a patient-centric approach and observe, through the European Medicines Agency’s example, how it is being adopted in regulatory processes.

What is a ‘patient-centric’ approach?

There is an increasing need to leverage patient experience, insights and data to better understand the reality of living with a specific condition, and the provision and effectiveness of care. Patients are now stakeholders for their health; they are widely encouraged to be active in their own care and well-being, driven by greater transparency in treatment pathways and options, and a better disease understanding.

A patient-centric approach is based on a partnership between patients and clinical/regulatory decisions-makers, resulting in the joint construction of a care option that puts the patient at the centre of the treatment paradigm.

In more sophisticated settings, this approach allows the monitoring of the paradigm’s implementation and allows for incremental improvement of it over time.

This partnership results in a synergy between health professionals’ expertise and patient experience acquired over the course of their lives. Such an approach, through focusing the review of new treatments on areas that matter most to patients, contributes to improve the development and assessment process, and ultimately the value provided by new health technologies.

Figure 1: The ingredients of a well-functioning patient-centric system [Adapted from Shifting the dial 2017] [2]

How are patients involved in EMA processes at the European level?

At the European Medicines Agency (EMA), patients have been involved for several years throughout the regulatory procedure, with the view of increasing transparency & trust in regulatory processes and fostering mutual respect between regulators and patients [1].

For instance, patients have been involved in the analysis of drug information prepared by the Agency, participation in guideline preparation, and have a voice in scientific advisory groups and scientific committees of the EMA.

The added value provided by patients on the Scientific Committees, based on their real-life experiences of their conditions and the therapeutic environments, is an essential and unique contribution.

Figure 2: Roadmap on Patient Involvement in regulatory processes – EMA [Adapted from EUPATI] [3]


Despite the acknowledged value of this approach, the inclusion of patients in HTA processes is not uniformly distributed around the world. Some countries have implemented mechanisms well before others to more broadly include the involvement of patients' groups in assessment processes.

Given obvious successes, why then do disparities exist between countries in their use of patient knowledge and experience? How does the level of patient involvement differ between countries?

In our next article we will analyse the different levels of patient involvement in HTA processes in a selection of countries, along with a detailed analysis in France.

  • Authors:

  1. Sandrine Belkhous, Analyst, Life Sciences
  2. Mitun Patel, Manager, Life Sciences



  • Sources

     [1] R.N. Battista, M.J. Hodge, The evolving paradigm of health technology assessment: reflections for the millennium CMAJ, 18 (1999), pp. 1464-1467


    [3] Academy EP. Guidance for patient involvement in HTA. Available at:

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