There is a growing body of evidence showing that patient-stakeholder engagement at key decision points throughout the medicines life cycle (from discovery to outcomes monitoring) can drive better innovation and process efficiency and quality. Processes and outcomes become more relevant to individual patients, patient groups, healthcare consumers in general and society at large when they are based on a mutual understanding between patients, other healthcare stakeholders and manufacturers about their respective needs.
Many initiatives have been started that focus on bringing the patient closer to the centre of medicines development, authorization and reimbursement processes in the EU. Progress, however, remains too slow, mainly because of lack of harmonisation:
Therefore, there is the need to establish transparent and integrated standards that permit patient involvement during the medicines lifecycle (including associated products and services). The resolution of 4 specific issue groups is required to make progress: recognition of the validity and value of such engagement; metrics to demonstrate value; capability development; and rules of engagement.
In the context of this project, the scope of the term “patient” includes those people who have the medical issues or symptoms as well as those caring for or living with them.
This project represents an opportunity to enable patients to better provide their perspectives - in qualitative and quantitative terms - in the medicines pathways from discovery to outcomes monitoring and beyond. The input from those who are currently under-represented, or may not normally participate in critical decision-making is of particular interest, including patients not affiliated to patient groups, vulnerable populations such as minors or the elderly. In addition, it will provide a framework and guidance for all EU stakeholders about who and how to engage, when and what information is required, to ensure adequate input from patients and healthcare consumers.
The project will specifically aim at addressing several challenges that currently hinder productive patient-stakeholder engagement:
The project will not address policy development advocacy nor will it duplicate any deliverables specifically addressed under other IMI and relevant non-IMI-initiatives.
Beyond filling obvious gaps in the engagement toolkit/practice, the project will build on existing tools and learn from good and bad experience and advance their utility.
The project’s aim is not intended to set a rigid framework or oversystematise patient-stakeholder engagement but instead to provide a blueprint and tools that will enhance engagement and making it a seamless part of the R&D and decision making processes.
The project is expected to advance patient engagement and medicines life cycle and make it more meaningful, systematic and effective. It will facilitate and further enhance patient perspectives in the process. This will be accomplished through creating more clarity on the process and provide patient and their partners in research with the tools that facilitate smooth and useful interaction. Enhanced and systematic engagement of patients and healthcare consumers in medicines lifecycle will ultimately contribute to:
The applicants will propose a course of action with the maximum impact for the patients’ communities and for the quality of interactions in the medicines lifecycle.