Canada: Pharmacapsules @ Gowlings: December 16, 2008

Last Updated: December 24 2008

Edited by Jennifer Wilkie and Chantal Saunders

Contents

  • 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:
http://www.gowlings.com/resources/enewsletters/DrugPricingReimbursement/ 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:
http://www.washingtonpost.com/wp-dyn/content/article/2008/11/18/AR2008111802926.html?hpid=moreheadlines and
http://www.statesman.com/news/content/news/stories/world/11/19/ 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:
http://decisions.fca-caf.gc.ca/en/2008/2008fca354/2008fca354.html

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:
http://decisions.fct-cf.gc.ca/en/2008/2008fc892/2008fc892.html

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:
http://decisions.fct-cf.gc.ca/en/2008/2008fc1305/2008fc1305.html

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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