Definitions of participants

In projects where pharmaceutical companies and patient organisations work together, roles need to be defined precisely as this will have an impact on what information you can share with whom and how you can work with them. A person or group may be defined in more than one way depending on the role and responsibilities they have in a particular activity.

What the ABPI Code says

The ABPI Code states that “prescription-only medicines must not be advertised to the public” (Clause 26.1), reflecting UK regulations relating to advertising.

The “public” includes individual patients. Sometimes the term “patient” is replaced by “people affected by” or “consumer”.

The ABPI Code defines ‘Patient Organisations’ in Clause 1.15:

1.15 ‘Patient organisation’ means an organisation mainly comprising of patients and/or caregivers or any user organisation such as a disability organisation, carer or relative organisation and consumer organisation that represents and/or supports the needs of patients and/or caregivers.

Additional sources of guidance

EFPIA gives the following definition of patient organisations in its Code of Practice on relationships between pharma and patient organisations:

“Patient Organisation (PO): non-for-profit legal person/entity (including the umbrella organisation to which it belongs), mainly composed of patients and/or caregivers, that represents and/or supports the needs of patients and/or caregivers and which business address, place of incorporation or primary place of operation is in Europe.

Patient Organisation Representative: is a person who is mandated to represent and express the collective views of a PO on a specific issue or disease area.”

The European Patients’ Academy on Therapeutic Innovation (EUPATI) uses the term “patients” to cover all the following definitions:

“Individual patients” are persons with personal experience of living with a disease. They may or may not have technical knowledge in R&D or regulatory processes, but their main role is to contribute with their subjective disease and treatment experience.

“Carers” are persons supporting individual patients such as family members as well as paid or volunteer helpers.

“Patient advocates” are persons who have the insight and experience in supporting a larger population of patients living with a specific disease. They may or may not be affiliated with an organisation.

“Patient organisation representatives” are persons who are mandated to represent and express the collective views of a patient organisation on a specific issue or disease area.

“Patient experts”, in addition to disease-specific expertise, have the technical knowledge in R&D and/or regulatory affairs through training or experience, for example EUPATI Fellows who have been trained by EUPATI on the full spectrum of medicines R&D.

The term “expert patients” or “patient experts” has no legal standing, and can refer to different aspects of expertise. There are many different definitions of an expert patient, including the technically trained patient in the EUPATI definition above; or someone who has taken part in a course on self-management for people with a long-term condition. Some definitions focus on the skills and experience of the patient in terms of their ability to communicate confidently and effectively, perhaps taking a broader view based on more than just their own experience. It could be a combination of experience of an illness, plus the wider knowledge of current thinking about a disease, and the ability to communicate meaningfully in a way that helps educate pharmaceutical companies and health professionals. For example, a patient who has participated in many events may have expertise in best practice for patient involvement, in what makes for a good conference experience for patients and what matters most for patients with their health condition.

The table below (from The Expert Patient: towards a novel definition – Jean Francois Cordier, The European Respiratory Journal) gives some useful examples of the different skills that could define expert patients; they might have different combinations of academic as well as experiential skills and may help to determine the skills required when seeking an expert patient or patient expert:

Experiential and academic skills that define expert patients

Experiential

Academic
Personal knowledge of illness and treatment Knowledge of the disease and treatment
Education as a patient, including self-management Academic education as an educator/teacher
  Participation as an educator/teacher with health professionals in patient education, including self-management, and taking into account patient values and priorities for clinical decision-making 
Collaborative relationship with the general practitioner and proximity specialist Collaborative relationship with academic specialists
Membership of patients’ associations Responsibilities in patients’ associations (e.g. as a board member)
Attendance at local patient meetings Attendance and active participation in regional/national/international patient meetings
Participation (as a patient) in clinical studies/therapeutic trials Participation as a partner in the design of clinical studies/therapeutic trials
Dispute resolution procedure Executive sponsor oversight from each party

This list is not exhaustive (e.g. expert patient participation in physician education should be considered).

In its publication Working Together: An Essential Guide, the Patients’ Association recommends asking what is appropriate for a specific situation when agreeing definitions:

Whilst it is important to be aware of semantics, it is perhaps of greater importance to be aware of the context in which you are working. Individuals should be asked at the beginning of any project how they would like to be identified. This will help to ensure people involved have a form of self-identity they feel comfortable with, and empowered by.

When developing definitions, asking questions like the ones below can help to clarify roles:

  • What is the purpose of communicating with an individual or group?
  • Will I be giving or receiving information?
  • What information will I be passing on?
  • Could this be viewed as promotional material?
  • What skills, experience or other qualifications am I looking for?
  • How will I consider and use the information and feedback I receive?

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Last modified: 20 September 2023

Last reviewed: 20 September 2023