RESUMO
Pharmacovogilance policy, methods and practice require transformation at all levels to create an integrated, comprehensive, continuously improving system, fulfilling the broader remit of overall healthcare vigilance. In pursuit of this vision, energetic measures, including active engagement with patients, are needed to reduce our ignorance about many aspects of patients' experience of medical therapies and their outcomes, including the benefits, but especially the extensive harm known to be caused by medical interventions. More information and communication in this domain will help set more accurate and realistic public expectations about the benefits and harm of therapy. All aspects of medicines development, regulation and use must be characterized by openness, transparency, ethical practice and a primary focus on the benefit and self-determined choices of patients. Notwithstanding, progress has been made in medicines safety information and communication but significant gaps and deficiencies remain. Promotion of the most beneficial use of medicines and the prevention of harm have not advanced sufficiently. This paper is a report from a group of experts, following previous similar decade reviews: the Erice Declaration (1996) and the Erice Manifesto (2006).