Canada: All Eyes On Hospitals: Mandatory Drug And Medical Device Adverse Event Reporting

Last Updated: July 10 2019
Article by Lydia Wakulowsky and Edona Vila

Traditionally, Health Canada has only required drug and medical device manufacturers to report serious adverse drug reactions and adverse events involving these products. Health Canada has now rolled out amendments to its Food and Drug Regulations and Medical Device Regulations, both made under Canada's criminal law powers and the authority of the Food and Drugs Act, that require hospitals to report to Health Canada serious adverse drug reactions and medical device incidents. Health Canada has set December 16, 2019 as the coming into force date for these new mandatory reporting requirements.

According to Health Canada, there are approximately 775 hospitals in Canada that are expected to be subject to these reporting requirements1. These hospitals will be tasked with updating education modules and training for front line staff to identify reportable events under the new regulations, and updating policies and operating procedures to manage their collection of information and reporting obligations.

Below are some considerations for hospital administrators:

  • Hospitals may wish to carefully consider the defining parameters of what is reportable. There are two buckets of mandatory reportable events: "serious adverse drug reactions" (SADRs) and "medical device incidents" (MDIs):
    • A SADR is "a noxious and unintended response to a drug that occurs at any dose that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death".
    • A MDI is "a failure of a medical device, a deterioration in its effectiveness or any inadequacy in its labelling or in its directions for use that has led to the death or serious deterioration in the state of health of a patient, user or other person or could do so were it to recur"2.
  • These new regulations do not create mandatory reporting obligations for individual health professionals. These regulatory obligations rest solely with "hospitals", which are defined as "a facility (a) that is licensed, approved or designated as a hospital by a province in accordance with the laws of the province to provide care or treatment to persons suffering from any form of disease or illness; or (b) that is operated by the Government of Canada and that provides health services to in-patients". However, health professionals would be required to cooperate under hospital professional staff by-laws, rules and regulations, and policy.
  • Subject to available exemptions, the timeline for reporting such incidents is 30 days from the date on which the event is first documented by the hospital. While the required reporting content for SADRs and MDIs is not identical, some required reporting for both include: the name of the hospital, identifying information for the drug or medical device, the date on which the event was first documented, the description of the event, any contributing factors to the event or any medical condition of the patient that directly relates to the event on the patient's health.
  • Control is an important element for triggering reporting obligations. Specifically, the hospital is exempt from reporting SADRs when the hospital does not have in its "control" all of the following information: the drug's name (whether its brand, proper, or common name), the patient's age and sex, and the description of the SADR. Similarly, the hospital is exempt from MDI reports, if the hospital does not have in its control the name or identifier of the medical device and a description of the MDI. As well, these new reporting requirements exempt certain therapeutic products including: a vaccine administered under a routine immunization program, cells, tissues and organs, blood and blood components, semen, and drug and devices regulated under clinical trial and Special Access Program frameworks.
  • The process of reporting does not require hospitals to perform a causality assessment to determine whether a drug or medical device causes the reportable reaction or incident.
  • Health Canada has prepared a guidance document3 and other materials including posters and reporting forms to assist hospitals with compliance.4

It is expected that these mandatory reporting requirements will increase the number of reports received by Health Canada and hospitals must carefully prepare and consider internal reporting protocols in the next six months.

It remains to be seen how the information collected by Health Canada will be used by Health Canada and other relevant stakeholders. We expect that, at least in any future litigation involving the particular event, a hospital's disclosure to Health Canada will be considered a relevant production for the purpose of the litigation, whether the hospital is a party to the litigation or not. This increases the importance of ensuring a robust compliance system for these new mandatory reporting obligations.


1  Regulations Amending the Food and Drug Regulations and Medical Device Regulations (Serious Adverse Drug Reaction Reporting- Hospitals): SOR/2019-190, Canada Gazette, Part II, Volume 153, Number 13. Retrieved from the Canada Gazette website.

2  Ibid.

3  Draft Guidance Document, Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents by Hospitals, Retrieved from the Health Canada website.

4  Serious Adverse Drug Reporting Form for Hospitals, Retrieved from the Health Canada website; Mandatory Reporting Poster, Retrieved from the Health Canada website.

About BLG

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

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

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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 (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

To Use 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.


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.


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