Orphan drug incentives in the pharmacogenomic context: policy responses in the US and Canada

Advances in pharmacogenomic research and increasing industry interest in personalized medicine have important implications for the way that orphan drug policies are interpreted and applied. Concerns have been raised about the potential impact of pharmacogenomics and new genomic technologies on our understanding of how disease categories are delineated, and subsequently, how the concept of rare disease should be defined for the purposes of orphan drug policies. This article considers whether orphan drug legislation can be drafted in a way that will maximize benefits and minimize concerns relating to the impact of pharmacogenomics on orphan drug research and development. After reviewing the issues that may arise at the intersection of orphan drug policies and pharmacogenomics, this article will discuss the potential impact of pharmacogenomics at two critical points: orphan designation and approval of the drug product. At each of these points, the relevant aspects of current US orphan drug legislation are examined, focusing on the extent to which recent amendments may address concerns that have been raised previously. This analysis will then provide the foundation for a critical review and recommendations regarding the proposed new Canadian orphan drug framework.     

Second‐hand Emotion? Exploring the Contagion and Impact of Trauma and Distress in the Asylum Law Context

Applicants' accounts of experiences of fear, trauma, violence, and persecution are central to the process of claiming asylum. These narratives are, at a human level, primed to provoke emotional responses, not only in the narrator but also in those to whom the account is relayed. In this article, we explore the vectors of emotionality that permeate asylum decision‐making in the United Kingdom, focusing particularly on the risk faced by the professionals involved of suffering vicarious trauma. More specifically, based on a series of 104 semi‐structured interviews with asylum stakeholders and observation of 48 appeals to the Immigration and Asylum Chamber of the First‐tier Tribunal, this article identifies the adoption by legal and quasi‐legal professionals of emotional coping strategies – of detachment and denial of responsibility – that risk being deployed in maladaptive ways that jeopardize the prospects for justice.