Canada: Pharmacapsules @ Gowlings February 9, 2009

Last Updated: February 17 2009

Edited by Jennifer Wilkie and Chantal Saunders


  • NICE to Launch an Independent Study of How to Account for Value in New Health Technologies
  • Obama's Prescription Drug Plan
  • FDA Requires Increased Disclosure of Bioequivalence Studies for ANDA Applicants
  • Recent Decisions

NICE to Launch an Independent Study of How to Account for Value in New Health Technologies
By Natalie de Paulsen

The National Institute of Health and Clinical Excellence (NICE), the United Kingdom's independent organisation responsible for providing guidance on health promotion and treatment of ill health, has confirmed that it is undertaking a study of how value is accounted for when assessing new health technologies. In a NICE press release Sir Mike Rawlins, the Chairman explained, "understanding the value, to patients, of new health technologies is central to the work that NICE does in advising health professionals, patients and the wider public on the best approach to improving the quality and consistency of care provided by the NHS." This study will be led by Professor Sir Ian Kennedy, emeritus professor of health law, ethics and policy at University College London.

For more information, please see:

Obama's Prescription Drug Plan
By Natalie Rizkalla-Kamel

U.S. President Obama is proposing to reverse the FDA's policy that shut down access to Canadian pharmacies in the U.S.. Obama's prescription drug plan would allow seniors to choose where to buy their prescription drugs, including Canada and other developed countries where safe drugs are available.

For more information, please see:

FDA Requires Increased Disclosure of Bioequivalence Studies for ANDA Applicants
By Melissa Binns

Effective July 15, 2009, the U.S. Food and Drug Administration (FDA) will require applicants of an abbreviated new drug application (ANDA) to submit all data from bioequivalence studies that have been conducted on the particular drug formulation submitted for approval. Currently ANDA applicants (typically generic drug manufacturers) are only required to submit studies which demonstrate bioequivalence, however, this new rule will require the submission of all studies conducted on the same product, including any studies which do not demonstrate bioequivalence. It is believed that enabling the FDA to examine all available information should assist in the accurate determination of whether the generic drug in fact bioequivalent to the reference listed drug. Additionally, applicants will also be required to submit an annual report of post marketing bioequivalence studies and data conducting on the approved drug formulation. The FDA intends to issue a short guidance document for ANDA applicants providing additional information on this amendment and a recommended format for the submissions.

For more information, please see:

Recent Decisions
By: Beverley Moore

Apotex v. AB Hassle; appeal of a motion to set aside decisions on the merits of 55.2 proceedings; 2008 FCA 416; Omperazole; December 22, 2008

The Court of Appeal upheld the decision of the trial judge refusing to set aside decisions in two previous cases.

Apotex was unsuccessful in two previous cases relating to omeprazole but was successful in a third. Apotex filed the motions that were the subject of this appeal, seeking to set aside the decisions in the first two cases. The basis for these motions was an allegation that Apotex' tablets had not changed between the three proceedings and given the conclusion of the judge in the third proceeding, the first proceeding should have been decided in a different manner.

The Court of Appeal found that the Trial Judge had declined to exercise discretion to set aside the two previous orders on the basis that Apotex was attempting to reverse the effects of its unsuccessful litigation strategies by arguing that the cases might have been decided differently if Apotex had conducted itself differently. The Court of Appeal found no error in this decision and dismissed Apotex' appeals.

The full text of the decision can be found at:

Immunex Corporation v. Canada (Minister of Health); listing decision; 2008 FC 1409; Etanercept; December 23, 2008

The Court upheld the Minister's refusal to list the patent on the Patent Register on the basis that it did not contain a claim for the dosage form. The Court held that the claim of the patent claimed a metered dose inhaler for dispensing an inhalation drug formulation comprising the medicines but then construed this claim as an improvement to a device. The Court accepted the Minister's interpretation of the dosage form as an inhalation aerosol despite the definitions in the Regulations defining a dosage form as a delivery system for administering a medicinal ingredient.

Thus, under these interpretations, the patent did not include a claim for the dosage form as defined, and the Court upheld the decision of the Minister. The Court also refused to consider any expert evidence in its decision.

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.

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