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

• Author: Petit, Elodie

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 life and health of patients, especially when they are of the presymptomatic or predictive kind, warrant a systematic enquiry into similarities and differences in the regulatory environment surrounding lab-based genetic test services in Canadian provinces. Is a governmental operating license always necessary? Is the peer-delivered accreditation process similar? An empirical study of the regulatory themes put forward by the provinces would allow for a greater understanding of the legal frameworks governing genetic test services offered in Canadian labs. This information is also essential to lay the groundwork for future regulatory harmonization of genetic tests across the Canadian provinces as well as internationally between Canada and other countries. Using qualitative research and document analysis methods, we herein present the results of an empirical thematic study of the regulatory measures over genetic test services in Canadian provinces.

Materials and Methods

In order to identify and compare the legal frameworks governing genetic services labs across Canadian provinces, we undertook a systematic empirical study for each province of the legal documents, both statutes and regulations, retrieved from the Canadian legal electronic database Canadian Legal Information Institute (CanLII) and the published literature obtained from a search of the Pubmed and Index to Canadian Legal Literature (LawSource) databases. The Canadian territories were not included in the present analysis. Selective keywords were used for the literature searches: 'laboratory', 'genetics', 'diagnostic facility', 'accreditation', 'quality', 'hospital', 'health' and 'license'. Only provisions at the provincial level and not lower jurisdictions, such as regional health authorities, were searched. The documents were then organized by jurisdiction and themes. For completeness, we consulted numerous websites including the College of Physicians and Surgeons website for each province and the Canadian Council on Health Services Accreditation (CCHSA) website. When necessary, some of these institutions were contacted by e-mail to obtain further detailed information. All documents were analyzed for their contents independently by each investigator and coded for accuracy. After independent content analysis, investigators conferred to reach a consensus on identified themes and regulatory frameworks.

Results

We identified six emergent themes pertinent to regulation of genetic tests in Canada.

1. A Fragmented Legal Framework Between the Federal and Provincial Jurisdictions

   The Canadian regulatory framework governing genetic tests is fragmented as a result of the constitutional division of powers between the federal and provincial levels of government. This institutional arrangement gives rise to two categories of genetic tests control, depending upon the jurisdiction.

   First, genetic tests marketed as in vitro diagnostic devices are mostly subject to federal control by virtue of its authority in criminal matters. The Medical Devices Regulations (1), under the Food and Drugs Act (2), covers genetic tests and provides a series of measures meant to assess their safety, as well as their effectiveness, prior to their commercialization. Aside from the basic requirements that medical device manufacturers must meet (e.g. obligation of identifying the inherent risks associated with a device and either eliminating these or reducing them, the requirement that the product performs as intended, etc.) (3), categorizing genetic tests as Class III devices (corresponding to a high individual health risk or a moderate collective health risk) requires that a license be issued by the Medical Devices Bureau of Health Canada's Therapeutic Products Directorate. (4) To obtain this license, the genetic test manufacturer must provide a summary of all studies relied upon to ensure that the device meets safety and effectiveness requirements. In addition, a summary of investigational testing conducted on the device using human subjects representative of the intended users (and under conditions similar to the conditions of use), as well as a copy of the certificate on quality management system certifying that the system under which the device is designed and manufactured satisfies the National Standard of Canada CAN/CSA-ISO 13485:03, entitled Medical devices--Quality management systems--Requirements for regulatory purposes must be provided. (5) All Class III and IV medical devices must undergo a scientific and medical review of submitted evidence of safety and effectiveness before their licence applications can be finalized. (6)

   Second, when the tests are offered as a service by a laboratory they are outside the scope of the Medical Devices Regulations and fall under the provincial jurisdiction. (7) The Constitution Act of 1867 accords legislative powers relating to property and civil rights to the provinces, including services offered within a province. (8) Echoing the framework existing in countries such as Australia, France and the US (9), three main elements are recurrent, but are not always combined when it comes to regulating genetic services labs in Canadian provinces. As we shall present in more detail below, they include the requirement: (1) to hold a government-issued license, (2) to obtain a peer-delivered accreditation, and (3) the presence of established internal and external quality controls. (10)

2. What Role Does the Law Play in the Regulation of Genetic Services Labs?

   It is interesting to note that there is no specific law regulating labs offering genetic test services in any of the ten Canadian provinces. It seems as if provinces have avoided drawing a clear distinction between genetic tests and other medical tests. Thus, genetic tests fall under the general provisions that regulate medical labs in each province.

   Opting for the law as an instrument with which to regulate medical labs is not the rule. Only six provinces have preferred this normative strategy, with varying degrees of interventionism. While Quebec, Ontario and Saskatchewan each have enacted a specific law to regulate medical labs (11), Newfoundland has integrated a provision including labs into its regulations made under its Public Health Act. (12) British Columbia...