Table 3.

Excerpts extracted from the interviews and coded as part of the patient involvement definition theme

Interview	Stakeholder group	Excerpt	Code
SI17	Marketing authorization holder	We see it as a direct and constructive interaction with the patient during the entire life cycle of the medicine	Life Cycle of the Product
SI04	Regulator	It is not just that patients should just be passive acceptors of medicine and treatments, but they have now evolved to be collaborators with us	Active Involvement
SI19	Marketing authorization holder	I want to be active in making decisions about the medications I receive. So, for me, patient involvement is participating in everything, through every phase of the life cycle of the medicine where a patient can contribute to a decision	Life Cycle of the Product
SI01	Patient representative	It is very important now that we differentiate the expert patient from the regular patient. Expert patients will engage in higher patient engagement	Definition of Patient Involvement
SI02	Regulator	There is always an important difference in the definitions of patients because, of course, you can look at the individual patients who are using medicines On the other hand, the representatives of the patient community who can provide a more collective perspective on a certain patient group, so when I am talking about patient involvement, also in pharmacovigilance, I like to focus on the representative	Definition of Patient Involvement
SI12	Neutral party	Patient involvement or patient engagement would be the act of purposively placing the patient not only in the center but in the front of the drug life cycle to make sure that patient representatives are able to give input regarding what they believe is more correct so that we are not making assumptions about what patients want but asking patients and patient representatives what they want and need	Life Cycle of the Product
SI03	Regulator	The role of the patient is changing to be not just the person with an illness who receives treatment from a sort of higher authority; it is increasingly becoming and has been defined as a partnership and shared decision-making	Definition of Patient Involvement
SI01	Patient representative	Patient engagement is now a robust spectrum It can mean, at the top, someone who is out there to change the institutional policy, legislative practice and framework of global health; then, there are others who want to be national advocates, so they will be talking about their own countries’ health systems; and finally the patient advocate, who is attached to a general practitioner in primary health care, who is responsible only for their own health	Definition of Patient Involvement
SI04	Regulator	We say more engagement because it is really a two-way process	Definition of Patient Involvement
SI10	Patient representative	Patient involvement is where we are involving a patient in some way, shape or form to check a box. Patient engagement is where we actually engage the patients to allow them to actively participate, be part of maybe ideas or brainstorming or maybe even taking part in the decision about what needs to happen	Definition of Patient Involvement