Theme 3: Legal and regulatory environment

Theme 3: addressing the legal and regulatory environment for personalized medicine (PM) technologies and services, focusing on the co-ordination of associated or companion PM technologies as they move through the regulatory process.

Part 1: Health and safety regulation for PM technologies
Theme Leader: Tania Bubela, School of Public Health, University of Alberta

Navigating the regulatory environment in Canada and elsewhere is a significant challenge for developers working on PM technologies. One of the main challenges is that these technologies combine therapies, such as drugs or biologics, with diagnostic tests and sometimes with devices, but regulators apply separate regulatory pathways for diagnostics, devices and therapeutics. Regulators now recognize the need to update regulatory frameworks to coordinate the evaluation of combination products – the question is how. Dr. Bubela’s team is conducting a comprehensive international review of regulatory frameworks, ongoing developments, and recommendations for reform. The goal is to provide unambiguous guidance for PM developers and provide a forum for developers and regulators to meet and discuss key challenges.

Interested and Engaged Stakeholders: PM technology developers and regulatory agency decision-makers.

Part 2: Legal environment for PM technologies
Theme Leader: Timothy Caulfield, Faculty of Law, University of Alberta

Dr. Caulfield’s team is examining the nature and regulation of the Canadian private genetic testing environment, as well how existing legal norms may impact utilization of PM technologies. Specifically his team aims to investigate and describe the existing and developing Canadian private genetic testing market (which includes either Direct to Consumer (DTC) services, or private services for health systems, such as Myriad Genetics). The team also focuses on emerging developments, such as inexpensive whole genome sequencing. This investigation will move beyond an examination of federal and provincial regulatory regimes (e.g., Health Canada jurisdiction over DTC tests, privacy and health information) to include consideration of legal obligations and liabilities for healthcare providers. This analysis is informed by existing health law jurisprudence, for example, what are the implications of PM for informed consent, referral obligations, and duty of care.

In addition to providing a valuable and necessary picture of the regulatory environment, including potential regulatory gaps, this work will help identify factors that influence the impact of genetic testing and PM in clinical settings and on the Canadian healthcare system. For example, Dr. Caulfield’s team will examine how genetic testing services may be viewed in relation to the concept of ‘medically necessary’ under the Canada Health Act and definitions in complementary provincial/territorial health laws, and by extension their potential impact on current and future resource allocation decisions.

Interested and Engaged Stakeholders: academia, healthcare providers, PM developers, regulatory and healthcare system decision-makers, the public.