Existing codes of practice for patient involvement with various stakeholders do not comprehensively cover the full scope of research and development (R&D). The European Medicines Agency (EMA) has developed a comprehensive framework of interaction with patients and consumer organisations since 2006.
The European Patients’ Academy (EUPATI) guidance documents aim to support the integration of patient involvement across the entire process of medicines research and development with regulatory agencies, health technology assessment (HTA) bodies, ethics committees and the pharmaceutical industry.
Users may deviate from guidance according to specific circumstances, national legislation or the unique needs of each interaction. The guidance documents should be adapted for individual requirements using best professional judgment. You can read the editorial of the guidance here.
EUPATI has published four Guidance Documents on patient involvement in R&D covering ethics committees, health technology assessment bodies, regulatory processes and pharmaceutical industry-led medicines R&D. Each guidance document recommends working methods and processes and suggests specific activities and areas for patient involvement.
Each guidance suggests key areas with opportunities for patient involvement. All guidance documents should be periodically reviewed and revised to reflect evolution and legislation.