Canada: Judge Phelan's Comments For The Pharmaceutical Industry: Apotex Inc. v Canada (Minister Of Health)

In Apotex Inc. v Canada (Minister of Health) ("Apotex"), the Federal Court (the "Court") provided some guidance with respect to the procedure pharmaceutical companies should undertake to obtain a Notice of Compliance ("NOC"). Overall, the Court's findings suggest that pharmaceutical companies should put their best foot forward in their application or on appeal in front of expert panels considering or reconsidering their applications because overturning an expert panel's decision is often difficult with Courts showing deference to expert panels.

Background of the Case

On September 8, 2015, Apotex Inc. ("Apotex") applied for judicial review of the Director General's July 16, 2015 decision (the "Final SLS Decision"), denying Apotex's Abbreviated New Drug Submission ("ANDS") for 100 mg capsules of Apo-Progesterone. The Final SLS Decision was issued after a four-person internal panel of toxicological experts recommended upholding the Minister of Health's decision to issue a notice of non-compliance ("NON") on April 17, 2014 and a notice of non-compliance/withdrawal ("NON-W") on December 29, 2014, citing concerns that the proposed formulation contained "unusually high levels" of Sodium Lauryl Sulfate ("SLS"), a non-medical ingredient used as an excipient.

Federal Court's Response and Implications

Justice Phelan dismissed Apotex's application for judicial review finding there was no reason to interfere with the Minister of Health's decision. The decision raises several implications for stakeholders in the pharmaceutical and biochemical industry.

(a) Limits of Judicial Review

Courts are typically cautious to interfere with decisions made by an expert panel. This Court made several comments with respect to the panel affirming and supporting this deferential approach:

  1. ANDS applicants have a right and legitimate expectation to an independent and impartial panel, but cannot dictate the panel's composition, in this case demanding an external panel. The Director General has the discretion to convene an internal or external panel as long as it is impartial. The Court considered whether the panel was impartial but otherwise made no comment regarding the Director General's discretion to assemble the panel.
  2. The panel should be allowed to update itself on the "state of the art" using publicly available sources.
  3. The panel may comment on the nature and quality of the scientific evidence by referencing regulatory standards and is not required to draw the applicant out on front and centre issues.
  4. Panel members may have prepared notes during the hearing, so long as the ultimate decision is not cast in stone. This means that pharmaceutical companies should be attuned to how their submissions influence the decision-maker's drafted conclusions to determine how preliminary the notes truly are. Some indicators include: whether the notes are merely preliminary thoughts, and whether the panel kept an open mind, accepted the applicant's submissions and considered new information.

This deferential approach is in line with the other, albeit few judicial review decisions regarding NONs and NON-Ws, such as in Apotex Inc. v Canada (Minister of Health) (2009 FC 452), where Justice Phelan upheld the Minister of Health's decision and noted that it was "sufficient that the Minister's opinion or lack of satisfaction [be] rationally and adequately explained." This deference may also be a result of the Minister of Health's important task of ensuring that drugs that are on the market are safe and effective.

What has emerged, then, is a situation in which judicial review has become a tool of last resort and, even then, rarely results in a different decision. As a result, prospective ANDS applicants should consult counsel early and submit a fulsome ANDS in the first instance, as obtaining a favourable result after a request for reconsideration is often challenging.

(b) Evidence Relied On

The Court based its decision partly on the reasoning that Apotex put forward evidence that suffered from numerous shortcomings:

  1. Apotex's claim that the US-FDA approved an Apotex product with higher maximum daily intake of SLS was missing information, did not address the drugs' differing characteristics and did not address the other reasons why the excipient levels were approved.
  2. The evidence regarding toxicology of SLS was of low quality, included a study that the Bureau of Metabolism, Oncology and Reproductive Sciences rejected, was missing important information on the SLS such as tests and evaluations of toxicological endpoints, was sometimes unpublished and did not meet the current regulatory standards or comply with Good Laboratory Practice.

This highlights the importance of presenting comprehensive and persuasive studies to withstand detailed, technical and expert review. Submitting a few studies and stating that another jurisdiction approved a related drug is not, in other words, always sufficient.

(c) Timing

The Court considered Apotex's late application. It reasoned that, while Apotex filed its application late in the honest but mistaken belief that the Director General's communications with Apotex after the Final SLS Decision meant that the Director General would reconsider Apotex's request, the Court could still consider Apotex's application because Apotex had a reasonable explanation for the delay: if it filed for judicial review, any reconsideration would be terminated. As a result, pharmaceutical companies may, depending on the circumstances, still apply for judicial review after the deadline if they have a compelling explanation.

This article was written with the helpful contribution of Patricia Wood (Articling Student).

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
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
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
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 (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