ISSUE: There is little experience with patient preference in regulatory decisions. With the increased involvement of patients in different phases of the drug development process, how should the regulators take patient preferences into account? OVERVIEW: Patient opinions are now more systematically being considered in regulatory decisions about benefit-risk of drugs in the EU. The panelists will present their personal, sometimes conflicting views on whether patient preferences should be taken into account in informing market authorization decisions, and discuss what the state of the play is organizationally, scientifically, and methodologically. The moderator (Postmus) will briefly introduce the work conducted on patient preference pilots within the European Medicines Agency. Pignatti will argue that although methods for systematic elicitations of preferences are being explored, many questions remain open such as the validity of different methods, generalizability of results, and usefulness in the regulatory context. Demolis will discuss how the views of patients available in a survey may reflect feelings at a given stage of disease, influenced by hopes and fears, experience of failure/success and of adverse effects, which may change over time, and therefore regulators and physicians can better take patients' perspectives into account in a global value judgement. Tervonen will argue that authorization decisions of drugs with marginally positive/negative benefit-risk profiles should be justified with quantitative analyses that incorporate patient preferences, and while collecting preference data is not a trivial task, good research practices using theoretically sound methods allow to collect such data with high precision.