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

Summary

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request the rectification of their medical file if the information contained therein is inexact, incomplete, ambiguous, outdated or unjustified.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.

Discrimination

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

Conclusion

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.

Footnotes

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))

Norton Rose Fulbright Canada LLP

Norton Rose Fulbright is a global legal practice. We provide the world's pre-eminent corporations and financial institutions with a full business law service. We have more than 3800 lawyers based in over 50 cities across Europe, the United States, Canada, Latin America, Asia, Australia, Africa, the Middle East and Central Asia.

Recognized for our industry focus, we are strong across all the key industry sectors: financial institutions; energy; infrastructure, mining and commodities; transport; technology and innovation; and life sciences and healthcare.

Wherever we are, we operate in accordance with our global business principles of quality, unity and integrity. We aim to provide the highest possible standard of legal service in each of our offices and to maintain that level of quality at every point of contact.

Norton Rose Fulbright LLP, Norton Rose Fulbright Australia, Norton Rose Fulbright Canada LLP, Norton Rose Fulbright South Africa (incorporated as Deneys Reitz Inc) and Fulbright & Jaworski LLP, each of which is a separate legal entity, are members ('the Norton Rose Fulbright members') of Norton Rose Fulbright Verein, a Swiss Verein. Norton Rose Fulbright Verein helps coordinate the activities of the Norton Rose Fulbright members but does not itself provide legal services to clients.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Topics
 
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions