Canada: Pharma In Brief - Overview Of Select Legal Issues Facing The Future Of Personalized Medicine


In the last decade, the expansion of research in genetics, genomics and other personalized healthcare approaches has allowed physicians to customize medical treatment according to patients' genetical, anatomical and physiological characteristics, their environment and their interactions with such environment. While the evolution of "personalized medicine" will continue to be influenced by developments in science, its commercial success will largely depend upon the legislative framework governing such treatments, and more particularly the regulation over: the concept of "medically required services", the protection of personal information, the administration of medical files, the communication of genetic information, genetic testing, genetic discrimination and insurance contracts. Keeping in mind the tremendous significance and complexity of this topic, this article intends to provide a brief introduction to some legal issues pertaining to genetic testing, privacy and human rights issues associated with genetic information.

Genetic tests

One concern raised by genetic tests is that at-home test kits are neither prohibited by nor subject to federal regulation. Accordingly, patients can purchase such kits online and undertake – without supervision or assistance – tests that could reveal sensitive information regarding their health. While some may attempt to interpret their own test results (giving rise to the risk of misinterpretation), others wishing to have a better understanding could consult a physician. Such consultations could then lead to various duties on the physicians' part, for example, to provide the medical follow-up required by the patient's condition. However, due to the potential dubious quality of unregulated tests (and results), the duty to provide assistance and follow up could be difficult for physicians to determine.

Another concern raised by genetic tests concerns the ability for patients to control the information added to their medical records, once the results of these tests are analysed by a physician. Canadian law generally provides that patients may request the rectification of their medical file if the information contained therein is inexact, incomplete, ambiguous, outdated or unjustified.  Provided that the genetic test information is accurate, and is in fact included in the patient's medical record, a patient will not be able to request the removal of all (or part) of such information. Likewise, medical opinions, interpretations and diagnoses cannot usually be altered within a medical record. Once added, such results and their interpretation will form an integral part of a patient's medical file and are subject to being communicated to third parties, for instance when a person agrees that an insurance company may have access to all information in his medical record.

Communication of genetic information to family members

Another legal issue is that discovery of diseases may have risk implications for patients' relatives, given that in some circumstances genetic information pertaining to a patient may be communicated to family members or third parties.

Even without the consent of the individual, various provincial laws provide that physicians and other persons may communicate personal information contained in a file  they hold on that individual to a person to whom the information must be communicated by reason of urgency, such as a life-threatening situation or the health and safety of the individual concerned.

For example, the Manitoba Personal Health Information Act permits disclosure when the trustee of personal health information "reasonably believes that the disclosure is necessary to prevent or lessen a serious and immediate threat to [...] the health or safety of the individual the information is about or another individual." The law also provides that, "[e]very person whose life or bodily integrity is endangered is entitled to receive the care required by his condition"1 and any person or any group of person should be warned should their health condition be threatened by a "significant risk of serious bodily harm." A similar duty is also vested in physicians2. While the Canadian Medical Association's code of ethics precludes them from using confidential information to the prejudice of a patient, it nonetheless stresses that, "[a] physician's paramount duty is to protect and promote the health and well-being of the persons he attends to, both individually and collectively." Even if confidentiality has been held to be especially important in respect of genetic disorders as they bear upon present and future consequences on the patient's autonomy and private life, some argue that, should a patient refuse to reveal genetic information to his relatives, his physician could, in certain circumstances, take appropriate measures to warn them, provided that this information is important to their health and well-being. Conversely, others took the view that the "serious harm threshold" will not generally be met as the information revealed solely by genetic tests is probabilistic and imprecise per se.


One of the advantages of personalized medicine is the ability to stratify patients, so physicians can identify the different forms a disease may take and maximize the effects of drugs by using them on the appropriate patients. However, a downside of such stratification is the possible discrimination it could create. Canadian law does not confer a free-standing protection against genetic discrimination. However, a constitutional guarantee of equality and a prohibition against discrimination on grounds such as disability or handicap is enshrined in the Canadian Charter of Human Rights and Freedoms as well as in the provincial charters and human rights codes.

In insurance contracts however, the use of health as a risk determination factor does not constitute discrimination. Recently, the Canadian Life and Health Insurance Association released a position statement on genetic testing. While this statement indicated that, "[i]nsurers would not require an applicant for insurance to undergo genetic testing," it also emphasizes that, "[i]f genetic testing has been done and the information is available to the applicant for insurance and/or the applicant's physician, the insurer would request access to that information just as it would for other aspects of the applicant's health history." Accordingly, this statement provides for weak guarantees, and given that insurance contracts are "good faith" contracts where the insured has an obligation to divulge any information that may be relevant to the contract, the insured may well be required to disclose the information revealed by such tests.  There have been a few legislative attempts in Canada as well as in foreign jurisdictions to deal with the provision of genetic information to insurers, and it will be interesting to follow up on the attempts to deal with non-discrimination and their specific impact on personalized medicine3


The evolution of personalized medicine will be influenced by scientific advances, but also by society's perspective on this form of medicine. Many unresolved policy issues are likely to influence the prospects for such treatments. Likewise, with the growing advances in the availability and advantages of these treatments legislative action will be in various cases necessary to shape the opportunities for companies involved in these technologies, to clarify the rights and protections for Canadians, and to address concerns relating to the potential use of such information by third parties4.

*** This article first appeared in the Fall 2014 issue of BIOTECanada's insights magazine, Canada's pre-eminent biotechnology industry publication.


1. An Act Respecting Health Services and Social Services, (CQLR c S-4.2, s.7)

2 McInerney v. Macdonald, [1992] 2 S.C.R. 138.

3 Bill S-201, An Act to prohibit and prevent genetic discrimination, 2nd Sess, 41st Parl, 2013, (first reading 17 October 2013).

4 In Canada, a bill aiming to protect Canadians against genetic discrimination was introduced last spring, and re-tabled as Bill S 201 this past October. If adopted this Act will prevent genetic discrimination and will prohibit any person from requiring an individual to undergo a genetic test or to disclose the results of a genetic test as a condition: (i) of providing goods or services; (ii) of entering into (or renew) a contract with such individual; or (iii) of stipulating specific conditions in a contract. Its enactment will amend other laws (such as the Canada Labour Code, (RSC 1985, c L-2) and the Canadian Human Rights Act, (RSC 1985, c H-6))

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