Translating Novel Technologies from Bench to Bedside: A Legal Perspective on the Standard of Care
* Centre of Genomics and Policy, McGill University
Context: In order to translate novel technologies in the health care system in an efficient and durable manner, not only should regulatory requirements applicable in a given jurisdiction be satisfied, but the technology must also be recognized as part of the medical standard of care. This term has both a scientific and a legal meaning: What does this term mean in each context? What are its essential components and how are they proven? Which stakeholders should be engaged to facilitate a smooth bench to bedside translational continuum?
Objective: One of the GELS components of the Innovative chemogenomic tools to improve outcome in AML project is to outline the specific conditions found in the Canadian civil and common law case law on the legal recognition of novel technologies as standard of care. Understanding the legal concept of standard of care and its application by Courts is necessary in order to better prepare researchers for an orderly translation of their novel tools into the clinic.
Methods: Our data collection/analysis approaches include: (1) a comparative analysis of laws, regulations and legal literature on the recognition of diagnostic tests as standard of care in Canada and; (2) an analysis of the case law to identify the legal criteria for the recognition of a standard of care.
Results: This research was conducted using three legal databases: (1) Quicklaw; (2) LexisNexis; and (3) La référence DCL/REJB. Search terms used included: standard of care (“standard ou norme de pratique”), duty of care, medical liability (“responsabilité médicale”) (results: 40 cases). We have focused on results from the Supreme Court of Canada; however, a number of jurisdiction-specific cases (from the Ontario, Quebec, Alberta, Manitoba and British Columbia Courts of Appeal) were also reviewed to ensure jurisdictional representation. 10 doctrinal sources consisting primarily of scholarly, peer-reviewed publications specifically relating to Canadian legal practices were also reviewed.
Conclusion: Different obstacles related to the dearth of expertise in genetics among non-geneticists and the continuous new evidence arising from genomic-based research in cancer can challenge the integration of novel genomic-based technology into the clinical setting. Important consideration should be given to prior validation of novel tools by a wide range of specialists and efficient dissemination through scientific publications and guidelines. A good understanding of the legal concept of standard of care by clinicians is also key in facilitating this transition.