Health Law

Recent years has seen growing hype around pharmacogenomics—the study of the influence that genetic factors have on drug response—and its alleged revolutionary impact on the practice of medicine. Part of the expanding field of personalized medicine, pharmacogenomics is said to show promise for helping to diagnose disease, identify people at risk of disease, and fine-tune treatments. Drug companies are developing an interest in increasing the efficacy of their products by developing companion diagnostic tests that can stratify patient populations according to genetic predisposition to respond to drug therapies. Part of the reason for the interest in pharmacogenomics also appears to be profit-related: many of the highly specialized drugs pushed through the regulatory system in the context of personalized medicine come with an extraordinary price tag, which raises questions about the affordability of this drug development model. In earlier papers, we already explored the significant issues associated with the move towards niche markets (see this paper), and the use of ‘orphan-drug’ designation to speed up drug approval and extend monopoly-like protections (see this paper).

By Trudo Lemmens, Raymond DeVries, Lois Shepherd and Susan M. Reverby (this op-ed was originally published on April 28, 2015 in the Minnesota Post)

(The following commentary was also signed by 159 scholars of health law, bioethics, medicine and pharmacy from institutions in the U.S., Canada, Australia, New Zealand, the UK, and other countries. Their names and affiliations are listed in a document attached to the Minnesota Post commentary. Earlier UofT Law blogs already reported on the initiatives and controversies mentioned in this commentary. See here)

As scholars of health law, bioethics and medicine, we are calling on the Minnesota Legislature to conduct public hearings on psychiatric research misconduct at the University of Minnesota.

Reports abound of an apparent innovation crisis in the pharmaceutical sector, with some sources citing escalating drug development costs, declining new drug approvals, and an increasingly stringent regulatory environment. Concurrently, commentators refer to the death, or at least the decline, of the blockbuster model of drug development—where large, brand-name pharmaceutical companies rely on a portfolio of drugs that gross more than U.S. $1 billion per year—which has dominated the pharmaceutical sector for decades.

Decreasing the Data Deficit: Improving Canada’s Drug Regulatory System: Paper by Trudo Lemmens & Shannon Gibson now publicly available on SSRN.