and
Beverley Moore
Listing of Drug on Register of Innovative Drugs Maintained
Teva Canada Limited v. Canada
(Health)
Drug: Eloxatin®
The Federal Court of Appeal (FCA) dismissed Teva's appeal of a
decision dismissing Teva's judicial review of a decision of the
Minister of Health refusing to remove the drug Eloxatin® from
the Register of Innovative Drugs. The full text of the Application
Judge's decision can be found here and our summary of the decision can be
found
here. The FCA did not determine which standard should be used
to review the Minister's decision.
Teva requested that the drug be removed from the Register of
Innovative Drugs alleging it not to fit the definition of an
"innovative drug". An "innovative drug" is
defined in the Food and Drug Regulations to mean "a
drug that contains a medicinal ingredient not previously
approved..." by the Minister. There is no definition of
"previously approved". Teva argued that it must be held
to include mass authorizations under the Special Access Program
(SAP), as in this case, Eloxatin® had been widely available
abroad for many years and had been available in Canada for more
than eight years under the SAP.
The FCA discussed the approval process for drugs and held that
authorizations under the SAP are not an approval for the drug, as
drugs available under the SAP are not founded upon data and studies
that have established safety and effectiveness. Furthermore, the
current Regulations have a clarity and certainty as to
when a drug is approved: the issuance of a Notice of Compliance
(NOC) and Drug Identification Number (DIN). If the Court were to
adopt Teva's interpretation of drug approval, this clarity and
certainty would disappear as complicated factual inquiries would
have to be undertaken in order to determine whether a drug had
actually been approved. This is contrary to the scheme of the
Regulations. Finally, the subsection of the
Regulations relating to data protection was held to be a
limited special purpose section designed to implement certain
specific treaty obligations. Teva's interpretation of
"previously approved" would undercut those treaty
provisions.
The Court also dismissed Sanofi's cross-appeal holding that it
was directed against the Federal Court reasons and as such was
improper. However, the Court did consider each of the preliminary
objections on the merits. The Court found that Teva did have
standing to bring the application for judicial review. Furthermore,
the FCA held that as the Minister is obligated to
"maintain" the Register of Innovative Drugs, the decision
refusing Teva's request to remove the drug was a fresh exercise
of discretion and susceptible to a judicial review; it was not
merely the same decision it had previously made in adding
Eloxatin® to the Register of Innovative Drugs.
Other Industry News
Health Canada has published revisions to the Guidance Document: Patented Medicines (Notice
of Compliance) Regulations. The revisions go into effect
April 16, 2012.
Health Canada has announced changes to the Therapeutic Products Directorate's List of
Recognized Standards for medical devices.
The Natural Health Products Directorate has published its Status of Applications Quarterly
Report for Q3, October 1, 2011 to December 31, 2011.
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.
