Ethical frameworks

Evidence about benefits and risks of medicines can guide the communication about risks and safe use of medicinal products-but not all the way. Ethical questions arise when science cannot produce conclusive answers to important questions or when there is a tension between scientific knowledge and other values, beliefs or perceptions. Examples are questions around new, inconclusive evidence about potential adverse effects of marketed medicines or regarding unintended effects of risk communication, such as shame, changes in therapy adherence or stigmatisation experienced by individuals using a certain medicine. Ensuring adequate and timely communication about risks and safe use of medicines therefore depends partly on ethical considerations, such as the duty of beneficence to patients and communities, the patient right to autonomy and collective responsibility. Health communication practices need to be based on a fair balance of relevant ethical norms and values. In this chapter, an ethical perspective on medicinal product risk communication will be introduced and four areas of ethical tension and the contexts of uncertainty and trust are discussed, which should be taken into account when planning or evaluating communication events.