Canada: Pharmacapsules - July 2004

Last Updated: September 7 2004

Edited by Adrienne Blanchard and Jennifer Wilkie


  • Confidential Information Exempt From Disclosure Under Access To Information Act
  • Deadline For Natural Health Products Passes
  • U.S. Seeks To Reduce Cheap Drugs From Australia
  • U.S. FDA Concerned About Importation Of Canadian Drugs
  • Deadline To Amend Trips Agreement Extended Until 2005
  • European Harvard Mouse Patent Upheld
  • FDA Approves Marketing Of Leeches As Medical Devices

Confidential Information Exempt From Disclosure Under Access To Information Act

In a Federal Court decision dated July 6, 2004, the Court held that the Minister of Health could not disclose documents to a competitor of the company in response to an Access to Information (ATI) request given they contained confidential information.

The Minister of Health had proposed to release some documents in which information that the Minister of Health believed to be confidential was severed from the remainder of the document. The Court held that severed versions of these documents should not be disclosed where it would be possible that the snippets of publicly available information remaining in the documents might reasonably permit a third party to learn confidential matters by piecing together the remaining information. Accordingly, the pages from the comprehensive summary, and reviewer's notes and correspondence were exempt from disclosure.

The Court also commented on certain pages that were disclosed to the competitor without first consulting the brand name company. In particular, the Court held that the Notice of Compliance is not confidential and was correctly disclosed. However, the Court determined that the Minister wrongly disclosed the remaining documents that included information on the tracking of the company's submission for approval.

For the text of the decision, please see:

Deadline For Natural Health Products Passes

Natural health products which contain Priority 1 ingredients (ingredients that are listed on the Therapeutic Products Directorate's New Drugs List, available at can no longer be sold in Canada without a natural product number (NPN) unless a product licence application was filed prior to July 1, 2004. This marks the first phase of compliance procedures that the Natural Health Product Directorate (NHPD) will be implementing. All other natural health products without an identified health risk can continue to be introduced into the Canadian market upon filing a product licence application.

With respect to products containing Priority 1 ingredients for which a product licence application was submitted prior to July 1, 2004, inspectors are not supposed to recommend a refusal of market entry while the NHPD assesses the application. It is important to note however, that in order to avoid a refusal of market entry, the product specific submission number must be included with the shipping documentation. The submission number is issued by the NHPD upon receiving a product licence application. All such applications filed prior to July 1, 2004, should have a submission number by this time. The submission number allows an inspector to identify whether a product licence application has been filed for such a product.

The next phase of the compliance procedures with respect to products containing Priority 2 ingredients is scheduled to begin on January 1, 2005. Priority 2 ingredients include isolates, amino acids, fatty acids, concentrated volatile (essential) oils indicated for internal use, and extracts other than those prepared by traditional methods.

It should be remembered that any natural health product on the Canadian market that has not submitted a product licence application fails to meet NHPD's compliance policies and, as such, may be subject to enforcement procedures.

For more information, please see:

For more information on natural health product issues, please contact Lewis Retik.

U.S. Seeks To Reduce Cheap Drugs From Australia

The United States Congress is ready to approve a trade agreement with Australia that will allow pharmaceutical companies to prevent importation of drugs to the United States. It will also allow companies to challenge decisions made in relation to Australia's drug plan, which decide which drugs should be covered based on a cost-benefit analysis of the cost, safety and clinical benefits of the drug.

For more information, please see:

U.S. FDA Concerned About Importation Of Canadian Drugs

The U.S. Food and Drug Administration (FDA) has new evidence that a Canadian Web site advertising "Canadian generic drugs" shipped versions of drugs that were either fake, contaminated or of an incorrect potency. Further, certain contaminants known to have potentially dangerous interactions with other medicines were uncovered. The FDA purchased the drugs from a Canadian Web site that frequently sends spam e-mail touting its product.

For more information, please see Reuters News Release:

Deadline To Amend Trips Agreement Extended Until 2005

The World Trade Organization (WTO) has extended its deadline to adopt an amendment to the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The amendment is required to permanently implement an interim waiver of certain provisions of the TRIPS Agreement that WTO members agreed to last year as a means of providing developing countries with increased access to generic medicines. The extension of the deadline until March 2005 is required because the United States and developing countries do not agree on the interpretation of either the August 30, 2003 Decision (the interim waiver) or the effect of the Chairperson's statement that accompanied the August 30 Decision.

The August 30 Decision waived limited provisions of Article 31 of the TRIPS Agreement. The waiver allows WTO members to issue compulsory licences to companies to manufacture medicines for export to developing countries that lack their own generic manufacturing capabilities. The accompanying Chairperson's statement emphasized that the August 30 Decision was to be used for non-commercial objectives. The Chairperson's statement also sets out particular measures that should be taken by member countries to prevent diversion of the drugs away from their intended recipients. The United States' position is that the Chairperson's statement is part of the August 30 Decision and must be reflected in any permanent amendment to the TRIPS Agreement. Developing countries argue that the Chairperson's statement does not have legal status. The EU's position is that the Chairperson's statement may not have the same legal status as the August 30 Decision but states that it was a critical component of securing Member country agreement to the waiver.

For more information, please see:

Inside US Trade, "WTO to Extend TRIPS Amendment Deadline by Nine Months," – June 18, 2004.

For more information on this and other trade issues contact Rick Dearden or Wendy Wagner.

European Harvard Mouse Patent Upheld

A patent granted in Europe in 1992 to Harvard University on a mouse genetically altered to develop cancer has been upheld by the European Patent Office, although the application was limited to mice and not extended to rodents. The decision resulted from an appeal of a 2001 decision by a number of organizations, such as church, environmental and animal protection groups, in which the patent was upheld but was limited to rodents instead of mammals in general. Medical uses of the patent were found by the Patent Office to outweigh animal rights and ethical concerns surrounding the patent.

For more information, please see:

FDA Approves Marketing Of Leeches As Medical Devices

The FDA has approved the marketing by a French firm of leeches for medicinal purposes finding that the leeches meet the definition of medical device under the Food Drug and Cosmetic Act. Uses for the leeches include the removal of pooled blood found under skin grafts and the restoration of blood circulation in blocked veins.

For more information, please see:

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.

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