Canada: Pharmacapsules @ Gowlings: December 16, 2008

Last Updated: December 24 2008

Edited by Jennifer Wilkie and Chantal Saunders


  • Proposed Changes to Common Drug Review Process
  • FDA Opens Overseas Office in China
  • Recent Cases

Proposed Changes to Common Drug Review Process
By Wayne Critchley

Proposed changes to the Common Drug Review (CDR) process have been published for consultation purposes. According to the CDR, the changes are intended "to facilitate earlier access to drugs without compromising the high quality of CDR reviews." The deadline for comments is January 21, 2009.

One change would allow manufacturers to make resubmissions at a lower list price if the Canadian Expert Drug Advisory Committee (CEDAC) has indicated that a lower price would cause it to change a negative recommendation to a positive one. A second change would allow manufacturers to make submissions to CDR during the pre-NOC period. This procedure would be intended to lower the delay between marketing approval by Health Canada and the ultimate listing recommendation by CDR.

For a report on the proposed changes, please see: Htmfiles/V2N15_20081211.en.html

FDA Opens Overseas Office in China
By Natalie Rizkalla-Kamel

In response to recent problems in the safety of foods and other products imported into the U.S.A. from China - e.g. poisonous pet food and melamine-tainted dairy products - the Food and Drug Administration (FDA) has opened its first overseas office in China. The agency will have offices in Beijing, Shanghai and Guangzhou to certify inspections of U.S-bound Chinese exports. The agency will also be opening other offices in the coming months in India and Latin America.

The United States imported approximately $2 trillion worth of goods last year, including $320 billions in products from China. Health and Human Services Secretary Mike Leavitt stated, "...the volume of the goods has become so robust that it requires a change in strategy."

The aim of this new initiative is to help foreign governments strengthen their regulatory systems by setting quality standards, increasing the number of inspections outside of the U.S. and educating companies and their distributors. Approved third-party independent certifiers will be allowed, either private commercial labs or foreign government agencies, working under the supervision and oversight of the FDA.

For more information, please see: and 1119foodsafety.html

Recent Cases
By: Beverley Moore

Abbott v. Canada/Minister of Health; appeal of a listing decision; 2008 FCA 354; Meridia (sibutramine); November 17, 2008

The Court of Appeal upheld the decision of the trial judge and dismissed Abbott's appeal. As a result, the patent at issue was not added to the Patent Register.

The Court set a new standard of review of the Minister's decisions in such cases. The Court held that in cases regarding use patents, the Minister should determine first what use is claimed by the patent; then determine what use is approved by issuance of a NOC; and finally, determine whether the claimed use is an approved use.

In construing the patent, the Minister's decision should be reviewed on the standard of correctness. However, when determining the use approved by the existing NOC, this is a question of fact to be reviewed on a standard of reasonableness, due to the particular expertise of the Minister. With respect to the third question, as it relates to an application of the law to the facts, the factual component must be reviewed on a standard of reasonableness. However, the legal component of the question which relates to the interpretation of the Regulations must be reviewed on the standard of correctness.

Furthermore, the Court of Appeal upheld the trial judge's decision with regard to the use of evidence at the application stage. The general rule in an application for judicial review is that the record before the Federal Court should not include any documentary evidence that was not before the maker of the decision being reviewed. However, when dealing with a point of patent construction, it could be helpful for the judge to have the benefit of a formal expert opinion on construction in the form of an affidavit. Thus, the trial judge should have the discretion to admit such an affidavit.

The full text of the decision can be found at:

Eli Lilly v. Apotex; interlocutory motion; 2008 FC 892; cefaclor; July 21, 2008

In this patent infringement action, the Court held that the protective order in the proceeding only applied to documents produced and exchanged prior to trial and did not apply to documents filed as exhibits during the trial. This motion was brought to extend the protective order to documents provided during trial.

The Court held that the party seeking the protective order had the burden of establishing on a balance of probabilities the existence of a serious risk. The public interest in open and accessible Court proceedings must prevail otherwise. The Court further held that it would be contrary to the principle of open and transparent justice to seal an entire expert report simply because an appendix or a paragraph contains information described as private and valuable, the disclosure of which would be prejudicial. Only those portions which pass the applicable test would be expunged or sealed.

The full text of the decision can be found at:

Strauss Enterprises v. Canada/Minister of Health; judicial review; 2008 FC 1305; Strauss Energy SIX; November 21, 2008

Health Canada decided that Strauss Energy SIX was to be classified as a Schedule F drug under the Food and Drug Regulations, meaning that it still must be supported by a doctor's prescription. Strauss sought to review this decision on the basis that the product should be classified and regulated as a natural health product under the Natural Health Products Regulations, requiring no prescription.

One of the active ingredients in Strauss Energy SIX is yohimbe bark. The compound yohimbine in the bark is believed to have a stimulating effect. Yohimbine has been on Health Canada's list of drugs that require a prescription since 1984.

The arguments in this case centred around whether yohimbe bark and yohimbine are different substances. Strauss argued that they were because if Health Canada wanted to include yohimbe bark on Schedule F it would have. Thus the failure to include it indicates an intention not to regulate the bark. Health Canada only regulated yohimbine and its salts. The Minister conceded that yombine bark and yohimbine are different substances, however its position was that Strauss Energy SIX contains yohimbine and it doesn't matter whether it got there as a constituent of yohimbe bark or as a directly added ingredient.

The Court held in favour of the Minister's decision and referred to a similar situation had been decided by the Supreme Court in R. v. Dunn regarding psilocybin. In that case, psilocybin was listed in Schedule H, however the parent mushrooms were not listed. Yet the Court held that the reference of psilocybin or any salt thereof in Schedule H was sufficient to bring a natural plant product containing that compound within the ambit of the statute. There was no sound reason to depart from that approach in this case.

The Court further held that there was no duty of fairness owed when the Government is interpreting and enforcing the laws of Canada. Interested parties can attack the legal correctness of that interpretation but the Government does not need to give prior notice to or consult with such parties about the correctness of its interpretations before it acts on them.

The full text of the decision can be found at:

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.

In association with
Related Topics
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