Date: 20110308
Docket: A-211-09
Citation: 2011 FCA 86
CORAM: BLAIS C.J.
SHARLOW J.A.
STRATAS J.A.
BETWEEN:
APOTEX
INC.
Appellant
and
MINISTER OF HEALTH and
ATTORNEY GENERAL OF CANADA
Respondents
Heard at Toronto,
Ontario, on March 8, 2011.
Judgment delivered from the Bench at Toronto, Ontario, on March 8, 2011.
REASONS FOR JUDGMENT OF THE COURT BY: SHARLOW
J.A.
Date:
20110308
Docket:
A-211-09
Citation:
2011 FCA 86
CORAM: BLAIS
C.J.
SHARLOW
J.A.
STRATAS
J.A.
BETWEEN:
APOTEX INC.
Appellant
and
MINISTER OF HEALTH and
ATTORNEY GENERAL OF CANADA
Respondents
REASONS FOR JUDGMENT OF THE
COURT
(Delivered
from the Bench at Toronto, Ontario,
on March 8, 2011)
SHARLOW J.A.
[1]
Apotex
Inc. is appealing the judgment of Justice Phelan (2009 FC 452) dated May 5,
2009. That judgment dismissed the application of Apotex for judicial review of
the refusal of the Minister of Health to issue a notice of compliance for ASA
81 mg enteric coated tablets (“Apo-ASA”). Apotex had sought the notice of
compliance on the basis of an abbreviated new drug submission in which the
Canadian reference product was Bayer ASA 81 mg enteric coated tablets
(“Bayer-ASA”).
[2]
According
to subsection C.08.002.1(1) of the Food and Drug Regulations, C.R.C. c.
870, an abbreviated new drug submission may be filed if certain conditions are
met. Subsection C.08.002(2) sets out the required contents of an abbreviated
new drug submission. Those provisions read in relevant part as follows:
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C.08.002.1
(1) A manufacturer of a new drug
may file an abbreviated new drug submission for the new drug where, in
comparison with a Canadian reference product,
(a)
the new drug is the pharmaceutical equivalent of the Canadian reference
product;
(b)
the new drug is bioequivalent with the Canadian reference product, based on
the pharmaceutical and, where the Minister considers it necessary, bioavailability
characteristics;
(c)
the route of administration of the new drug is the same as that of the
Canadian reference product; and
(d)
the conditions of use for the new drug fall within the conditions of use for
the Canadian reference product.
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C.08.002
(1) Le fabricant d’une drogue
nouvelle peut déposer à l’égard de celle-ci une présentation abrégée de
drogue nouvelle si, par comparaison à un produit de référence canadien :
a) la drogue nouvelle est un
équivalent pharmaceutique du produit de référence canadien;
b) elle est bioéquivalente au
produit de référence canadien d’après les caractéristiques pharmaceutiques
et, si le ministre l’estime nécessaire, d’après les caractéristiques en
matière de biodisponibilité;
c) la voie d’administration de
la drogue nouvelle est identique à celle du produit de référence canadien;
d) les conditions thérapeutiques
relatives à la drogue nouvelle figurent parmi celles qui s’appliquent au
produit de référence canadien.
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(2) An abbreviated new drug
submission shall contain sufficient information and material to enable the
Minister to assess the safety and effectiveness of the new drug, including
the following:
…
(c)
evidence from the comparative studies conducted in connection with the
submission that the new drug is
…
(ii)
where the Minister considers it necessary on the basis of the pharmaceutical
and, where applicable, bioavailability characteristics of the new drug,
bioequivalent with the Canadian reference product as demonstrated using bioavailability
studies, pharmacodynamic studies or clinical studies …
|
(2) La présentation abrégée de
drogue nouvelle doit contenir suffisamment de renseignements et de matériel
pour permettre au ministre d’évaluer l’innocuité et l’efficacité de la drogue
nouvelle, notamment :
…
c) les éléments de preuve,
provenant des études comparatives menées dans le cadre de la présentation,
établissant que la drogue nouvelle :
…
(ii)
d’autre part, si le ministre l’estime nécessaire d’après les caractéristiques
pharmaceutiques et, le cas échéant, d’après les caractéristiques en matière
de biodisponibilité de celle-ci, est bioéquivalente au produit de référence
canadien selon les résultats des études en matière de biodisponibilité, des
études pharmacodynamiques ou des études cliniques; …
|
[3]
In
this case, the Minister considered it necessary for Apotex to establish
bioavailability with the reference product. Apotex does not challenge that aspect
of the Minister’s decision. Its abbreviated new drug submission included
evidence intended to prove bioavailability.
[4]
The
Minister has published a document entitled the “Report B Guidelines” dealing
with the methodology for bioequivalence studies for enteric coated drugs.
Apotex conducted the required tests, which included both a “fasted” study and a
“fed” study. The results of fasted study met the bioequivalence standards in
the Report B Guidelines, but the results of the fed study did not, in that it
included two subjects for which the data did not meet those standards.
[5]
Apotex
tried on numerous occasions to persuade the Minister that the data relating to
those two subjects should be disregarded as “outliers” (anomalies that ought to
be disregarded on scientific grounds). However, the Minister was not persuaded.
Apotex also tried to persuade the Minister that despite the results of the
bioavailability study, there was sufficient evidence that Apo-ASA was safe and
effective. The Minister rejected those arguments.
[6]
Apotex
brought an application for judicial review challenging the Minister’s decision
to refuse to issue a notice of compliance for Apo-ASA. Justice Phelan dismissed
the application for judicial review. In this appeal, Apotex asks for an order
reversing the judgment of Justice Phelan, requiring the Minister to reconsider
the refusal to grant the notice of compliance, and directing that the
reconsideration disregard the failure of the bioavailability study to meet the
Report B Guidelines.
[7]
We
agree with the Minister that all of the arguments of Apotex on this appeal are
based on the incorrect premise that it was open to the Minister to assess the
safety and efficacy of Apo-ASA without requiring proof of bioequivalence
between Apo-ASA and Bayer-ASA.
[8]
Pursuant
to subparagraph C.08.002.1(2)(c)(ii) of the Food and Drug Regulations,
the Minister cannot issue a notice of compliance for Apo-ASA on the basis of an
abbreviated new drug submission naming Bayer-ASA as the Canadian reference
product unless bioequivalence is demonstrated between Apo-ASA and Bayer-ASA.
That is because a notice of compliance for a new product based on an
abbreviated new drug submission is intended to recognize that the new product
and the reference product are the same in certain material respects, including
bioequivalence. In other words, even if a proposed new product is safe and
effective, it cannot be approved through an abbreviated new drug submission if
it is not bioequivalent to the reference product.
[9]
As
to whether bioequivalence has been proved in this case, that is a question of
fact to be determined by the Minister, reviewable by the Federal Court on the
standard of reasonableness. Justice Phelan correctly identified and applied
that standard of review to that question. Contrary to the submissions of
Apotex, the record does not disclose that Justice Phelan misunderstood or
misapplied the law relating to the fettering of Ministerial discretion.
Specifically, the factual conclusions stated by Justice Phelan in paragraphs
30-32 of his reasons were reasonably open to him on the record.
[10]
For
these reasons, this appeal will be dismissed with costs.
"K.
Sharlow"
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: A-211-09
(APPEAL FROM A JUDGMENT OF THE
HONOURABLE MR. JUSTICE PHELAN, DATED MAY 5, 2009, IN FEDERAL COURT FILE NO.
T-394-08)
STYLE OF CAUSE: APOTEX
INC. v.
MINISTER
OF HEALTH and
ATTORNEY GENERAL OF CANADA
PLACE OF HEARING: TORONTO, ONTARIO
DATE OF HEARING: MARCH
8, 2011
REASONS FOR JUDGMENT
OF THE COURT BY: (BLAIS,
SHARLOW & STRATAS JJ.A.)
DELIVERED FROM THE BENCH BY: SHARLOW
J.A.
APPEARANCES:
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Harry B. Radomski
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FOR THE APPELLANT
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Frederick Woywada
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FOR THE RESPONDENTS
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SOLICITORS OF RECORD:
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Goodmans LLP
Toronto, ON
|
FOR THE
APPELLANT
|
|
Myles J. Kirvan
Deputy Attorney General of Canada
|
FOR THE
RESPONDENTS
|
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