Impressions from a CIOMS Meeting In 2018 IFAPP, the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine, joined CIOMS, the Council for International Organizations of Medical Sciences, a non-governmental organization founded in 1949 by the WHO and UNESCO. On the occasion of CIOMS’s 70th anniversary Brigitte Franke-Bray, IFAPP Treasurer and member of their Communication Working Group, attendended the CIOMS Open Meeting on Patient Involvement in Development and Safe Use of Medicines on 30 April 2019 in Geneva, Switzerland. After an Introductory Session given by Hervé Le Louet, CIOMS President, Lembit Rägo, CIOMS Secretary General, gave an overview of 70 years of CIOMS: Ethics and safety guidance to protect patients as CIOMS focuses on Bioethics, Product Development and Pharmacovigilance (https://cioms.ch). We in IFAPP were pleased to see that he specifically mentioned IFAPP as a new member. Attendees from many countries and almost all continents were present. There were representatives from regulatory agencies from around the world including the European Medicines Agency, US FDA, PMDA, Health Canada, the NL Medicines Evaluation Board, from international associations such as ISPOR, IFPMA, IUPHAR, DIA, the World Medical Association and the WHO, as well as delegates from various patient organisations such as EURORDIS, EUPATI, EPF, EATG, India HIV/AIDS Alliance, only to mention a few, and also attendees from the pharmaceutical industry and service organisations. Emer Cooke, delegate from the WHO, presented their viewpoint on patient centricity in medicines regulations and how to improve it, and Theresa Mullin from the US FDA talked about the importance of working with patients. The role of patients in drug development was addressed by Marc Boutin from the US National Health Council (NHC) and Elisabeth Oehrlein, also from the US NHC, talked about patient involvement initiatives around the world. Here are my impressions of two of the outstanding presentations: An overview of the proposed CIOMS guidance was given by Kerry Leeson-Beevers from Alström Syndrome UK. Since 2017 several groups have been working on this “first global guidance document for patient involvement in the life cycle of medicines and the recognition of the importance of patient involvement and working together for the benefits of the patients and their care-givers”. A glossary of world-wide past and current definitions is also being developed. François Houÿez from EURORDIS talked about the guiding principles for engagement and how to avoid conflict of interests. Patients should be “involved at every level of decision making, in all decisions that affect their lives (1983 “Denver Principle of patient advocacy), they should participate in all forums with equal credibility as others, declare interest, respect confidentiality, and avoid insider trading. The engagement principles should be the same as for other experts” and that includes fair compensation for their activities acting as experts. “Being part of the decision-making process imposes responsibilities on the patients – and legal liability”. Each session of three presentations was followed by a panel discussion. The international audience was very active and asked many questions, and indeed there was not enough time to answer them all in this one-day event. This meeting was excellent and there should be more such events with open access to not only inform the experts in the pharmaceutical industry but also the general public.

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