Canada: Pharmacapsules @ Gowlings - December 2007

Last Updated: December 10 2007

Edited by Jennifer Wilkie and Chantal Saunders

Contents

  • Managing Health Claims For Foods in Canada - Discussion Paper, 2007
  • QLT INC. UP FOR SALE
  • EU, US Regulators Ease Process for Orphan Drugs
  • Alliance Proposes New Wait Time Benchmarks
  • Health Canada Update Notice on Registration and Disclosure of Clinical Trial Information
  • Update on the Comprehensive Review of the Special Access Programme
  • Recent Cases

Managing Health Claims For Foods In Canada - Discussion Paper, 2007

Article by Roger Tam

Health Canada released a discussion paper on November 30, 2007 entitled "Managing Health Claims for Foods in Canada - Discussion Paper, 2007" for the purpose of examining possible changes to the current framework for managing health claims on foods. The discussion paper notes that while consumers generally tend to view health claims as similarly credible, there are significant differences in regulatory requirements between rigorous risk reduction claims ("A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis") and maintenance claims ("Vitamin A aids in the maintenance of night vision"). Current guidelines are found in the 2003 Guide to Food Labelling and Advertising.

The purpose of the discussion paper is to respond to the increasing interest in the health value of foods, and for more efficient and transparent processes for the approval of health claims. Similar reviews are being conducted in the European Union, Australia, New Zealand and the U.S.

Issues raised in the discussion paper include :

  • Efficiency and openness of the assessment process
  • The need for international standardization
  • Requisite standards for scientific substantiation of claims
  • Interphase between foods and natural health products
  • Permissible health claims and how these should be delivered
  • Improving consumer understanding of health claims

For more information, please see: http://www.hc-sc.gc.ca/fn-an/consultation/init/man-gest_health_claims-allegations_sante_e.html.

Please note comments are due by February 29, 2008.

QLT INC. UP FOR SALE

Article by: Michael Herman

On November 27, 2007, Vancouver-based QLT Inc. announced that it has formed a special committee of directors to "review the company's strategic alternatives" which typically means that a company has put itself up for sale.

QLT's lead products are the eye drug Visudyne® and Eligard®, a prostate cancer therapy. QLT went public in 1986 and for a considerable period of time was a high flyer, regarded as one of the top life sciences growth stories in Canada. Its stock traded as high as $45.00 in 2000 before beginning a downward spiral. QLT's shares have fallen more than 50% in the past year alone to a recent low of $3.46 as its financial results have weakened and its products and technologies have failed to meet the expectations of the investment community.

QLT's struggles as a public company over the past few years have been consistent with the performance generally of many publicly traded biotech companies. Most recently, two other Canadian public life science companies, Axcan Pharma Inc. and Aspreva Pharmaceuticals Corporation have announced that they are being sold, Axcan to a US private equity fund and Aspreva to a Swiss-based diversified healthcare market group. In both cases, the purchase price for the companies represented a significant premium over the trading price of their shares on the public markets.

In Canada, public biotech companies have not fared well in 2007. The market capitalization of public Canadian life sciences companies is down by 30% in the first nine months of the year. However, in the US, notwithstanding a slump during the summer months, biotech stocks have performed rather well. At October 31st, 2007 the Burrill Biotech Select Index was up 17.5% for the year, led by companies such as Gilead Sciences and Illumina. The shares of prior year top performers, such as Amgen and Genentech, are down this year, suggesting that the maturing of public US biotech companies is attracting significant investor interest. Stephen Burrill, CEO of Burrill & Company, believes that biotech stocks will continue to improve led by new emerging and elite companies within the sector.

Another sign of improving fortunes for public biotech companies in the US is that at the end of October there had been 26 biotech initial public offerings in the US. While the IPO price for the shares of many of these companies was below the proposed range targeted, most of these new public companies have held their values quite well following their IPO's unlike the experience of many new public biotech companies in recent years.

Canadian public biotech companies have not faired as well as US companies in 2007. It will be interesting to see if the US trend toward rising prices for biotech shares extends to Canadian companies in 2008 or whether the recent pattern of sales of Canadian public biotech companies will continue.

For more information, please see: http://www.nationalpost.com/Story.html?id=130601

EU, US Regulators Ease Process For Orphan Drugs

Article by: Roger Tam

In an effort to encourage development of drug treatments for rare diseases, the European Commission, the European Medicines Agency and the U.S. Food and Drug Administration announced steps to streamline the application process for orphan drugs. Companies will be able to simultaneously apply in both jurisdictions using one application.

The U.S. Orphan Drug Act defines a "rare disease or condition" in the case of a drug to mean any disease or condition which a) affects less than 200,000 persons in the U.S; or b) affects more than 200,000 people in the U.S. and for which there is no reasonable expectation that the cost of developing and making available in the U.S. a drug for such disease or condition will be recovered from sales in the U.S. of such drug. In the EU, low prevalence is taken as less than 5 per 10,000 people in the EU. There are estimated to be between 5000 and 8000 such diseases today.

For more information, please see:http://today.reuters.com/news/articlenews.aspx?type=scienceNews&storyID=2007-11-26T183432Z_01_L2677301_RTRUKOC_0_US-DRUGS-REGULATORS.xml

Alliance Proposes New Wait Time Benchmarks

Article by: Marc Richard

A coalition of physician associations is pressing provincial governments to expand previously established wait time benchmarks to cover additional specialties. The Wait Time Alliance has proposed new benchmarks for emergency care, psychiatric care, plastic surgery, gastroenterology and anaesthesiology in a new report. The Alliance is hoping the provincial governments will announce initiatives to apply these benchmarks by the end of the year.

For more information, please see:http://www.cbc.ca/health/story/2007/11/26/waittimes-report.html

Health Canada Update Notice On Registration And Disclosure Of Clinical Trial Information

Article by: Jennifer Wilkie

On November 30, 2007, Health Canada posted a notice to provide an update on Health Canada's initiative on the registration and disclosure of clinical trial information for products such as drugs and medical devices. The notice indicates that Health Canada is currently considering development of regulatory requirements for registration of clinical trials and disclosure of results. However, in the meantime Health Canada is encouraging sponsors to register their clinical trials within 21 days of the commencement of a clinical trial using one of the WHO's register networks: the ClinicalTrials.gov (www.clinicaltrials.gov) or Current Controlled Trials International Standard Randomised Controlled Trials Number Register (www.controlled-trials.com/isrctn).

Health Canada is considering the creation of a Canadian search portal for clinical trials. The notice indicates that since the initiative was launched, Health Canada has conducted extensive consultations and has received a strong consensus among stakeholders that a Canadian approach should be consistent with the international direction. Further, the notice states that if a decision is made to proceed with the regulatory requirements, there will be further opportunity for stakeholders to provide feedback on the issues such as timing of registration, the registration of early phase trials and disclosure of clinical trial results.

The full text of this notice can be found at:http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/proj/enreg-clini-info/notice_ctreg_avis_ecenr_e.html

Update On The Comprehensive Review Of The Special Access Programme

Article by: Jennifer Wilkie

Health Canada recently updated their web site to provide comments on their ongoing comprehensive review of the Special Access Programme (SAP). The review of the SAP is said to consist of three sub-projects, namely an operational review to evaluate how SAP is functioning within the existing framework, an ethics review of the mandate and activities of the SAP and a broader policy/regulatory review.

Preliminary consultations occurred in June 2007 soliciting views from users of SAP in two sessions. A consequence of this has been the preparation of an issue identification paper. The issue identification paper sets out a brief history of the development of SAP and attempts to identify issues that may warrant change. A second phase of the review is to obtain comments on the issue identification paper. A third phase of consultation will begin in spring 2008 after the development of an options analysis paper resulting from the second phase consultations.

For more information, please see:
http://www.hc-sc.gc.ca/dhp-mps/acces/sap_pas_comp_e.html

Also, to review the SAP issue identification paper, please see: http://www.hc-sc.gc.ca/dhp-mps/acces/sap_pas_ident_e.html

Please note comments are due by December 17, 2007.

Recent Cases

Article by: Beverley Moore

Sanofi-Aventis v. Riva, preliminary motion to dismiss a judicial review proceeding; November 7, 2007, drug: rampiril.

The Minister of Health had sent a letter to the generic company indicating that once it had satisfied the requirements of the NOC Regulations, it would be eligible to receive a NOC regardless of whether the other generic company to which it had cross-referenced its submission had satisfied all of the NOC Regulations and received a NOC. The innovator sought to judicially review the decision in the letter.

The Court held that the letter from the Minister was not a "decision" in a sense that it could not be judicially reviewed.

The Court also held that if the letter was a decision, the innovator company did not have standing as it is not directly affected by the letter. Although the innovator's commercial interest could be affected, the commercial advantage conferred on the third party by the government does not give rise to standing to commence a judicial review application.

The full text of the decision can be found at: http://decisions.fct-cf.gc.ca/en/2007/2007fc1156/2007fc1156.html

Purdue v. Pharmascience, interlocutory motion on a section 55.2 proceeding;
November 15, 2007, drug: oxycodone

The Applicants brought a motion to reverse the order of evidence in the s.55.2 proceeding.

The Court found that it did have the discretion, in the context of case management, to vary the order in which evidence of the parties on an Application is to be served and filed, if it is necessary for the just, most expeditious and least expensive determination of the proceedings on the merits.

The Court saw the most potential for narrowing the issues and gaining efficiencies with respect to allegations of invalidity. The Court also found that if the generic company filed its evidence first it would serve to substantially narrow the issues to be litigated in the matter and it would be likely that far fewer expert reports would be needed. This in turn would limit the risk that reply would be sought or allowed and it would shorten the time frame necessary cross-examinations due to the busy schedule of experts.

However, in this case there was an issue relating to an alleged lack of sound prediction in the patent. The innovator agreed it would likely have to file factual affidavits from the inventors in response to this allegation. Thus, the motion was dismissed.

The full text of the decision can be found at: http://decisions.fct-cf.gc.ca/en/2007/2007fc1196/2007fc1196.html

Servier v. Apotex, interlocutory motion in an infringement action;
November 19, 2007, drug: perindopril

By this motion, two additional innovator companies sought leave to be added as defendants to Apotex' counterclaim against Servier under the Competition Act. Apotex alleged that Servier entered into a conspiracy with the two innovator companies and agreed to allocate amongst themselves certain patent claims that were the subject of a conflict proceeding between those parties. Apotex has made very similar allegations in a counterclaim under the Competition Act in a separate action involving the two innovator companies. Apotex and Servier opposed the motion.

The Court denied the motion. Plaintiffs are allowed to choose the defendants against whom they wish to proceed. The test is stringent to add a party to a proceeding. The Court found that the two additional parties would not be bound by the results of this action, as there is nothing in the jurisprudence or the Competition Act which indicates that establishing the elements of the conspiracy for one defendant relieves the burden on the plaintiff in any way in subsequent proceedings against another party on the same conspiracy.

The full text of the decision can be found at: http://decisions.fct-cf.gc.ca/en/2007/2007fc1210/2007fc1210.html

Apotex v. The Gov. in Council et al.; The Minister of Health et al. v. CGPA, appeal of decisions on motions to strike judicial reviews; November 27, 2007

In a pair of decisions, the Court of Appeal has indicated that judicial review applications brought by CGPA and Apotex attacking the vires of the Data Protection Regulations brought into force in October 2006 may be heard.

In a first appeal, Apotex was successful in overturning the decision of the motions judge who had found that Apotex did not have standing and struck out Apotex' application. The Court of Appeal found that the question of standing was subsumed in the motion to strike test and that for the purposes of the motion to strike, it was not plain and obvious that Apotex was not directly affected by the Data Protection Regulations and therefore allowed the appeal. The Court comments however that it will be up to the trial judge ultimately to consider the issue of standing.

In a second appeal, the Attorney General had sought to overturn a motions judge's decision finding that the Motion to Strike should be dismissed. The appeal was dismissed. The Court of Appeal found that the motions judge did not proceed on a wrong principle of law in finding the application should not be struck as it was not plain and obvious that the CGPA did not have public standing. Accordingly, these two proceedings may now proceed.

The full text of these decision can be found at: http://decisions.fca-caf.gc.ca/en/2007/2007fca374/2007fca374.html, http://decisions.fca-caf.gc.ca/en/2007/2007fca375/2007fca375.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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