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Regulatory News | 08 May 2017 | By Zachary Brennan
The European Medicines Agency (EMA) said Monday that it will continue to allow patients to offer viewpoints during the assessments of the benefits and risks of medicines before its Committee for Medicinal Products for Human Use (CHMP).
In addition to continuing to invite patients to oral explanations on a case-by-case basis, EMA will also look to use additional methods and consult patients on a more regular basis.
"This could include participating in CHMP discussions by teleconference or through written consultations at any time during an evaluation (respond to specific pre-defined questions). These options allow for consultations to be conducted outside of plenary meetings and not limited to oral explanations, they also give the opportunity to gather feedback from a larger number of patients, when required. Elicitation of patient preferences is also another patient engagement methodology which the committee and the EMA is currently investigating," according to a report on a patient perspective pilot project.
The pilot from September 2014 through December 2016 allowed patients to participate in CHMP discussions on the benefits and risks of Clinuvel’s Scenesse (afamelanotide) for the treatment of erythropoietic protoporphyria, Shire’s Intuniv (guanfacine) for the treatment of attention deficit hyperactivity disorder in children and adolescents, Biogen’s Tecfidera (dimethyl fumarate) for the treatment of multiple sclerosis, Biomarin’s Kyndrisa (drisapersen) for the treatment of Duchenne muscular dystrophy (DMD) and twice for PTC Therapeutics’ Translarna (ataluren) for the treatment of DMD.
"Patients report a very positive experience; they felt listened to and included and this increases transparency and trust in the work of the Agency," a report on the pilot said. "The CHMP members felt that it was ‘important’ and ‘very helpful’ to have the patient input during the oral explanation and subsequent discussions."
In addition to their involvement in CHMP discussions, EMA noted that patient representatives are also involved in the Pharmacovigilance Risk Assessment Committee, the Paediatric Committee, the Committee for Advanced Therapies and the Committee for Orphan Medicinal Products, in addition to working with various scientific advisory groups and reviewing documents for the public prior to publication, as well as the Patients' and Consumers' Working Party (PCWP), through which they provide recommendations to EMA and its human scientific committees on all matters of interest to patients in relation to medicines.
Involving patients in discussions on benefits and risks of medicines
Tags: patient perspective, CHMP, benefits and risks of medicines