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.     

Up and down the Zoning Scale

Zoning in this country has traditionally been a waiting game with the development proceess. Not knowing what specific property will be used for and not controlling the ball game suficiently to say what will be the use, land has been zoned in a “wait and see” classification. Some land has been overzoned for certain uses; other land has been left fairly open as to its potential use. Thus the system itself necessitates constant change in a property's classification as circumstances change. Many of these changes are made to accommodate a specific development proposal, so they are to the landowner's benefit. However, other rezonings result in a reduction in the landowner's potential for profit. It is this type of change—downzoning—that is the subject of this discussion.