Index
Introduction
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.
Guidance on Patient Involvement
The EUPATI guidance documents cover interaction with regulatory agencies, HTA bodies, ethics committees and the pharmaceutical industry aiming to interact involve patients in medicines research and development (R&D). 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.
The EUPATI guidance documents on patient involvement underwent extensive review by project members and all other consortium partners before being released for public consultation. The comments received from both rounds of review have ensured the guidance documents are robust and suitable for implementation.
There are four separate guidance documents covering patient involvement in:
Pharmaceutical industry-led medicines R&D
Ethics committees
Regulatory processes
Health technology assessments (HTA)
Each guidance suggests key areas with opportunities for patient involvement. All guidance documents should be periodically reviewed and revised to reflect evolution and legislation.
Contributors
Contributions to this first issue of the guidance documents have been provided by:
The Italian Medicine Agency(AIFA), Alzheimer Europe, Amgen, Bayer, DIA, European AIDS Treatment Group (EATG), European Federation of Neurological Associations (EFN), The European Forum for Good Clinical Practice (EFGCP), The Patients Network for Medical Research and Health (EGAN), European Patient Forum (EPF), Ethics Committee of the Medical University Hospital Vienna, The European Young Patients’ Advisory Group Networks (eYPAGnet), GlaxoSmithKline (GSK), Global Alliance of Mental Illness Advocacy Networks (GAMIAN), Fondazione Paracelso, French National Authority for Health (HAS), Health Technology Assessment international (HTAi), Leukaemia Foundation Australia, Ludwig Boltzmann Institute for Health Technology Assessment, The Medical Product Agency Sweden, The Medicines and Healthcare products Regulatory Agency (MHRA) UK, MSD, The National Institute for Health and Care Excellence (NICE) UK, Novartis, NovoNordisk, Patient Advocates for Cancer Research & Treatment (PACRT), Pfizer, Roche, The Scottish Medicines Consortium, Swissmedic, Central Manchester University Hospitals NHS Foundation Trust (CMFT), The University of Maryland School of Pharmacy, The Catholic University of Leuven, Belgium, Centre for Human Genetics.
