Reactions 1652, p5 - 20 May 2017 EMA final report on involving patients in benefit risk assessment The European Medicines Agency (EMA) has released its final report on its Committee for Medicinal Products for Human Use (CHMP) pilot project to involve patients in discussions on benefits and risks of new drugs undergoing assessment. It concluded that patients should be invited to take part in oral discussions when their input could be of value in an assessment, such as when the CHMP is considering whether to recommend authorisation of a new drug, to reconsider an existing authorisation, or to restrict an indication for an approved drug. During the pilot project, between September 2014 and December 2016 patients participated in discussions at CHMP meetings, giving their views on the benefits and risks of drugs including afamelanotide (Scenesse) for erythropoietic protoporphyria, ataluren (Translarna) and drisapersen (Kyndrisa) for Duchenne muscular dystrophy, dimethyl fumarate (Tecfidera) for multiple sclerosis, and guanfacine (Intuniv) for attention-deficit hyperactivity disorders in children and adolescents. Following the positive outcome of the pilot project, the CHMP agreed on additional methods to include patient involvement, including teleconference discussions and written consultations, which would permit patient input outside of CHMP meetings and input from more patients. European Medicines Agency. Involving patients in discussions on benefits and risks of medicines. Internet Document : 8 May 2017. Available from: URL: http:// www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/05/ news_detail_002742.jsp&mid=WC0b01ac058004d5c1 803243304 0114-9954/17/1652-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 20 May 2017 No. 1652