Canada: Pharmacapsules - June 2004

• Amendment To Natural Health Product Regulations

• Enforcement Of Natural Health Product Regulations

• Second Annual Statistical Report On The Patented Medicines Regulations Released

• Minister's Decision Refusing To List Patent Is Upheld

• Importance Of Providing Samples In Support Of Allegations Of Non-Infringement

• Whistleblower Reporting Systems

• Anti-Terrorism Laws Regulating Food And Drugs Come Into Force In Canada And The United States

A recent amendment to the Natural Health Product Regulations permits the Special Access provisions of the Food and Drug Regulations to apply to natural health products ("NHPs"). As a result, practitioners can request access to products classified as NHPs normally unavailable in Canada. Access can only be authorized for treatment on a compassionate or emergency basis for patients with serious or life-threatening conditions and where conventional therapies have failed.

For more information, see the amendment and comments at:

http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/sap_amendment_e.html

The Natural Health Product Directorate ("NHPD") has announced that as of June 30, 2004, it will begin enforcing the Natural Health Product Regulations against Priority 1 NHPs. Priority 1 NHPs are NHPs that contain at least one ingredient on the Therapeutic Products Directorate's New Drug List. This marks the first stage in a multi-stage enforcement approach, whereby the NHPD will enforce the Natural Health Product Regulations against one category of product at a time. It should be noted that all NHPs that are deemed as posing an unacceptable risk level will be subject to enforcement regardless of their priority listing or whether a Product License Application has been submitted.

The New Drug List is available at:

www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/newdrugs_e.html.

For more information and advice on NHP issues, contact Lewis Retik at Gowlings.

On May 14, 2004, Health Canada's Therapeutic Product Directorate released its second annual statistical report on the Patented Medicines (Notice of Compliance) Regulations. This report purports to be a statistical overview relating to the administration of the Regulations and in particular, addresses the Minister of Health's maintenance of the Patent Register. The report also outlines statistics relating to the requirements for second persons to address patents listed on the Patent Register, and statistics relating to the outcome of proceedings commenced as a result of Notices of Allegation being served.

A copy of this report may be found at:

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/patent_statistical_report_2003_e.pdf

In a decision dated May 20, 2004, the Court reviewed a decision of the Minister of Health refusing to add a patent that was filed in respect of a supplemental new drug submission. The Applicants argued that it had met all the timing requirements and that in the absence of evidence that it was trying to circumvent the Regulations, the Court should not look at the nature of the drug submission, but direct the Minister to list the patent. The Minister took the position that having regard to the regulatory framework of the Regulations, an administrative submission can never give rise to an opportunity to list a patent in light of certain earlier decisions.

The Court reviewed the legislation and commented that there is no distinction made in the Regulations between a new drug submission and a supplement to a new drug submission. Both are considered to be submissions for a Notice of Compliance thereby triggering the Regulations. However, the Court then found that the Applicants had not shown why the Toba Pharma decision should not apply in the present case. In particular, where the submission was an administrative one, merely for the purpose of changing the name of the ownership of the DINs and updating the product labelling, this was not a sufficient reason for the purpose of accepting the patent list submitted. Therefore, the Court upheld the Minister's decision to refuse to list the patent and dismissed the application.

For more information, please see the decision:

http://decisions.fct-cf.gc.ca/fct/2004/2004fc736.shtml

By a decision dated May 25, 2004, the Court reversed a decision refusing an innovator's request to introduce evidence of results of testing generic's tablets. An issue in the case is whether the generic's tablets would infringe the innovator's patent. The basis for the initial denial of the request was delayed in bringing the motion, however, the Court reversed holding that evidence relating to samples was vital for deciding the case and that both parties were at fault for the delay. The Court added that it is not in the interest of the Court to have the matter proceed to hearing without the best evidence, even if it meant delaying the final hearing of the application.

For more information, please see the decision:

http://decisions.fct-cf.gc.ca/fct/2004/2004fc762.shtml

Many corporations are either grappling with the design and implementation of internal whistleblowing reporting systems, or considering the potential impact of proposed whistleblower legislation. The Inkster Group can assist organizations in designing and implementing whistleblowing-reporting systems, and has recently launched "EthicsAlarm", an independent third- party anonymous hotline for employees to report behaviour that is injurious, unlawful or otherwise questionable. For more information please contact Dan Bilak at (416) 369-6648, or Norman Inkster at (416) 369-7210.

For further details on this service, please visit:

http://www.inkstergroup.com/about/ethicsalarm.asp.

The U.S. Food and Drug Administration (FDA) has adopted the final regulations required to implement section 303 of the Public Health Security and Bio-terrorism Preparedness and Response Act of 2002. Under section 303 of the Act, the FDA may order the detention of any article of food found in the course of an inspection, examination or investigation conducted pursuant to the federal Food, Drug and Cosmetic Act if the FDA possesses "credible evidence or information" indicating that the article presents a threat of serious adverse health consequences or death to humans or animals.

The FDA obtained the authority to administratively detain food when the Act was enacted on June 12, 2002. The Act required the FDA to make rules establishing expedited procedures for perishable foods. The new regulations, which come into force July 6, 2004, clarify the procedures for detention, the appeal process, and related matters for both perishable and non-perishable foods. Critics say that the expedited procedures for perishable foods will not prevent the food from losing its marketability pending appeals and hearings.

Additionally, anti-terrorism legislation in Canada (Bill C-7 - The Public Safety Act, 2002) received royal assent on May 6, 2004. Bill C-7 amends 23 existing Acts, including the Food and Drugs Act and Department of Health Act. Both Acts are amended to provide a new power permitting the Minister of Health to make interim orders on any matter that would otherwise be required to be made by regulation. An interim order may be made if the Minister believes that immediate action is required to deal with a significant risk, direct or indirect, to health or safety. The order ceases to have effect after 14 days unless approved by the Governor in Council, in which case the order may remain in effect for one year.

For more information concerning the U.S. regulations under section 303 of the Bio-terrorism Act, see:

http://www.fda.gov/bbs/topics/news/2004/NEW01073.html

For the text of Canadian Bill C-7, The Public Safety Act, 2002, see:

http://www.parl.gc.ca/common/bills_ls.asp?Parl=37&Ses=2&ls=c17

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.