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An empirical analysis of the legal frameworks governing genetic services labs in Canadian provinces.

Introduction

In Canada, the regulatory framework governing genetic tests is complex and is not systematically harmonized across the Canadian provinces or between different legal jurisdictions. For example, when genetic tests are sold as diagnostic in vitro kits, they primarily fall under the purview of the Health Canada pre-market launch requirements regarding their safety and effectiveness. By contrast, when such tests are offered as a service in a laboratory setting they do not fall under federal jurisdiction, but rather provincial jurisdiction. The proliferation of genetic tests available to the public as well as the importance of the information they contain about the ...

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