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).
In a new paper, “The Promise and Peril of Adapting the Regulatory System to the Pharmacogenomic Context” just published in the McGill Journal of Law and Health (freely downloadable on this SSRN page), we (Shannon Gibson & Trudo Lemmens) focus on the significant regulatory challenges associated with the need to approve both a pharmaceutical drug and a companion diagnostic. This is complicated in Canada by the fact that authority to regulate these two different types of products is fragmented between different levels of government, different provinces, and even different agencies within the same level of government.Moreover, drug regulators are often less familiar with the diagnostics sector and may thus be uncertain of how these technologies impact on drug safety and efficacy. Although regulators in various jurisdictions are ramping up efforts to determine the most appropriate means of incorporating pharmacogenomic information into drug evaluation and regulatory decision making throughout the stages of drug development, Canada continues to lag behind other jurisdictions – particularly the US – in adopting significant reforms.
We explore how pharmacogenomic drugs and tests are evaluated and approved within the current Canadian regulatory system. Even if it has evolved over time, the current regulatory framework still largely reflects a very traditional drug development model that dates from before the advent of pharmacogenomics. This creates significant uncertainty around how pharmacogenomics should be dealt with within the existing system. Informed by both the literature and qualitative interviews we conducted with key Canadian stakeholders, in the paper we assess what reforms may be necessary to more effectively evaluate and regulate these emerging health technologies. We begin by looking at, first, the split regulation of companion diagnostics by federal and provincial authorities and, second, how pharmacogenomic products are currently integrated into the drug regulatory system at the federal level. Subsequently, we consider reform efforts—perhaps most significantly Vanessa’s Law, Canada’s new drug safety legislation—to better coordinate the review of drug and test components, to offer more flexible approaches to market authorization, and to expand regulatory oversight during the post-market phase. We make a number of recommendation about how pharmacogenomic products may be more effectively regulated in Canada, including through:
- harmonizing standards for laboratory-developed diagnostics tests, such as through a more nationalized accreditation system or an interprovincial organization to coordinate reference standards;
- putting in place procedures that allow for some level of coordination between those responsible for the approval of the diagnostic test and those responsible for the approval of the pharmaceutical component;
- improving the transparency of the existing notice of compliance with conditions process and passing regulations to implement greater transparency requirements under Vanessa’s Law;
- developing stricter requirement for risk-management planning, including measures that would allow regulators to put firmer restrictions on the ability to prescribe certain drugs without first conducting pharmacogenomic testing; and
- expanding the existing guidance document on pharmacogenomic information to include more standardized direction on how pharmacogenomic information should be presented in drug labelling.
This work was part of a project on Ethical and Legal Issues of Cancer Initiating Stem Cell Research, funded by Genome Canada, through the Ontario Genomics Institute.
Shannon Gibson & Trudo Lemmens
