Date: 20101201
Docket: T-152-10
Citation: 2010 FC 1211
Vancouver, British Columbia, December 1,
2010
PRESENT: Roger R. Lafrenière, Esquire
Prothonotary
BETWEEN:
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CANADIAN GENERIC PHARMACEUTICAL
ASSOCIATION
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Applicant
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and
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THE MINISTER OF HEALTH AND
GLAXOSMITHKLINE INC.
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Respondents
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REASONS FOR ORDER AND ORDER
[1]
The
Respondent, GlaxoSmithKline (GSK), seeks an order dismissing the application
for judicial review commenced by the Applicant, Canadian Generic Pharmaceutical
Association (CGPA).
[2]
GSK
submits that the application is bereft of any possibility of success for two
reasons. First, the application does not pertain to a
“decision” within the meaning of section 18.1 of the Federal Courts
Act. Second, CGPA lacks standing to seek judicial review – either as a
“person interested” or in support of the “public interest”.
[3]
For
the reasons that follow, I conclude that CGPA is not a person directly affected
by the decision within the meaning of section 18.1 of the Federal Courts Act,
nor a person entitled to make the application in the public interest. Since the
finding of lack of standing is determinative, it is not necessary to consider
whether the decision at issue in the application is amenable to judicial
review.
Facts
[4]
By
way of background, GSK obtained a Notice of Compliance
(NOC) for Avamys® (fluticasone furoate) on August 14, 2007. On
October 26, 2009, Avamys® was added to the Register of
Innovative Drugs (Register) maintained by the Minister of Health (Minister)
pursuant to section C.08.004.1 of the Food and Drug
Regulations, C.R.C. 1978, c. 870 (Regulations). As a result of being listed on the Register, no generic
manufacturer can file an abbreviated new drug submission (ANDS) for fluticasone
furoate until August 14, 2013 and no NOC can issue until February 14, 2016.
[5]
CGPA is an industry association representing
most generic drug manufacturers in Canada with
respect to regulatory and legal issues affecting its members. By
letter dated December 14, 2009, CGPA wrote to the Office of Patented
Medicines and Liaison (OPML), on behalf of the Minister, requesting that
her decision be set aside and that Avamys® be removed from the
Register. CGPA alleged that Avamys® (i.e.,
fluticasone furoate) is an ester variation of a previously approved medicinal
ingredient (i.e., fluticasone propionate) and falls outside the definition of
“innovative drug” under the Regulations.
[6]
CGPA’s
request was refused by the Minister on January 6, 2010. The
Minister advised CGPA that fluticasone furoate and fluticasone
propionate are both esters of fluticasone. Since fluticasone
is not a medicinal ingredient “previously approved in a drug by the Minister”, fluticasone
furoate is not a “variation of a previously approved medicinal ingredient”.
[7]
CGPA
subsequently brought the present application to review the Minister’s decision
to maintain Avamys® on the Register of Innovative Drugs by Notice of Application dated February 3, 2010. CGPA
claims that the Minister erred in failing to grant its request to remove Avamys®
from the Register on the basis that it is a variation of a previously approved
medicinal ingredient (i.e., fluticasone propionate). In its prayer for relief,
CGPA seeks: (i) an order of mandamus directing the Minister to remove
fluticasone furoate from the Register; or (ii) alternatively, a declaration
that fluticasone furoate ought not to have been added to the Register and its
listing has no legal effect.
[8]
Mr. James Keon, president of CGPA, filed an affidavit in response
to GSK’s motion to strike. Mr. Keon states that developing a generic
version of a brand name product and obtaining approval from Health Canada is a very costly and
time-intensive process for generic drug manufacturers. According to Mr. Keon,
if CGPA is not permitted to bring this proceeding challenging an improper
listing on the Register of Innovative Drugs, then it is unlikely that any of
CGPA member companies would individually challenge the listing of fluticasone
furoate. This is because each company would be required to make a substantial
investment in developing a fluticasone furoate product and conducting expensive
and necessary studies to support an abbreviated new drug submission. The delay,
burden, uncertainty and cost of litigation challenging the listing of
fluticasone furoate on the Register of Innovative Drugs by an individual
company would be significant.
[9]
On
cross-examination, Mr. Keon admitted that CGPA is not a drug manufacturer, that
it does not file new drug submissions and that it has never received a notice
of compliance nor sold a drug product in Canada. In particular, CGPA has never filed a drug
submission for fluticasone furoate (AVAMYS®). Mr. Keon refused to
answer whether the association intends to do so in the future. He also refused
to say whether CGPA represents the public interest, such as the provincial
formularies, patients or drug purchasers. He would only say that CGPA
represents the interests of its Member Companies.
Analysis
[10]
GSK
submits that the Minister’s refusal to remove Avamys® from the
Register at CGPA’s request is not a “decision” that can be reviewed by this
Court. GSK maintains that the refusal was really no more than a reconsideration
of an earlier decision, and not a separate decision. For the purpose of these
reasons, it is irrelevant which decision is at issue in the application. As noted in the preamble, the key issue to be decided on
this motion is whether CGPA has standing to seek judicial
review of the initial decision to add fluticasone furoate to the Register,
or the refusal by the Minister of CGPA’s request to remove the drug from the
Register - either as a person interested or on behalf of
the public interest.
[11]
This Court has jurisdiction to strike an application for judicial
review if it is “bereft of all possibility of success”: Lundbeck Canada Inc.
v. The Minister of Health et al., 2008 FC 1379 at para. 34, aff’d 2009 FCA
134; Apotex Inc. v. Canada (Governor
in Council), 2007 FCA 374 at para. 16. However, an application for judicial review should
only be dismissed on an interlocutory motion in the clearest cases. In most
cases, the Court’s resources should not be expended on motions to strike, which
can more efficiently be addressed at the hearing of the application itself: David
Bull Laboratories (Canada) Inc. v. Pharmacia Inc, [1995] 1 F.C. 588 at
para. 10.
[12]
An
exception to the general rule is made, however, where the applicant clearly has
no standing to bring the application: Apotex Inc. v. Canada (Governor in Council), 2007 FC 232 at para.
33. The Court may determine the issue of standing as a preliminary matter on a
motion to strike an application for judicial review where there is sufficient
material before the Court in terms of facts, law and arguments for an
understanding as to the nature of the applicant’s interests. This criteria is
met in the present case. The Court has the benefit of evidence from CGPA on
the issue of standing, and comprehensive submissions from
the parties.
Whether
CGPA is “Directly Affected”
[13]
CGPA submits that it has standing because it is
“directly affected” by the listing of fluticasone furoate on the Register. It contends that the refusal to recognize the standing of
collective organizations, on the basis that only the members of the
organization are “aggrieved”, is increasingly being viewed as too formalistic: Alberta
Liquor Store Assn. v. Alberta (Gaming & Liquor Commission), 2006 ABQB
904 (Alberta Liquor) at para. 20.
[14]
This Court has, in a number of cases, allowed an
organization to bring an application on behalf of its members. In fact, in Canadian
Generic Pharmaceutical Assn. v. Canada
(Governor in Council), 2007 FC 154 at para.
17, aff’d 2007 FCA 375 (CGPA v. Canada), Mr. Justice Sean Harrington
held, on a preliminary motion, that CGPA had standing to challenge the vires
of the data protection provisions of the Regulations as a person
“directly affected” because CGPA was “not an officious inter-meddler”. The Federal Court of Appeal affirmed Justice Harrington’s findings on
public interest standing, but declined to comment on his finding that “it was
not plain and obvious that the Respondent was not ‘directly affected’ within
the meaning of section 18.1”.
[15]
However, the circumstances of the present motion
to strike are distinguishable from those before Justice Harrington. Unlike the
present motion, no particular drug product was at issue in CGPA v. Canada.
This is, in my view, a critical distinction. CGPA cannot, simply as a result of
its status as an association, acquire a greater standing or be in a better
position than its individual members to challenge a listing decision.
[16]
In Alberta Liquor, at para. 9, Mr. Justice
Slatter listed a number of factors that must be weighed in determining whether
a party is “aggrieved”. An important factor was the relationship between the
applicant and the challenged decision, or how directly the challenged
administrative act will affect the legally-recognized interests of the
applicant. The same factor applies for applications brought in this Court. In
order to be “directly affected”, within the meaning of section 18.1 of the Federal
Courts Act, the decision must adversely affect a
party’s legal rights, impose a legal obligation, or cause direct prejudice: Rothmans
of Pall Mall Canada Ltd. v. Canada (Minister of National Revenue), [1976] 2
F.C. 500 (F.C.A.), CanWest MediaWorks Inc. v. The Minister of Health et al.,
2007 FC 752 at para. 13, aff’d 2008 FCA 207; Independent Contractors and
Business Assn. v. Canada
(Minister of Labour), [1998] F.C.J. No. 352
at paras. 30-31 (F.C.A.).
[17]
CGPA wholly fails to meet this test. CGPA is a
trade association that advocates on behalf of member companies. It does not
manufacture generic drugs, nor does it submit drug submissions, obtain NOCs, or
sell drugs in Canada. Neither CGPA, nor
admittedly any of its members, have filed a drug submission for fluticasone
furoate, or even expressed any intention, present or future, to manufacture the
drug. As a result, the decision under review (to maintain
the listing of fluticasone furoate on the Register)
does not adversely affect the legal rights of CGPA itself, or any of its
members. Further, on the evidence before me, the decision also does not impose
any legal obligation or cause them any direct prejudice.
[18]
It should be noted that, under the Patented
Medicines (Notice of Compliance) Regulations, SOR/93-133 (“PM(NOC)
Regulations”), generic manufacturers do not have standing to challenge the
Minister’s decision to list a patent on the Patent Register unless they have
filed an ANDS referencing a drug to which the impugned patent relates: Apotex
Inc. v. Canada (Minister of National Health and Welfare) (1998), 82 C.P.R.
(3d) 65 at para. 5 (F.C.T.D.). By analogy, a manufacturer of generic drugs does
not have standing to challenge the Minister’s decision to list a drug on the
Register of Innovative Drugs unless it has attempted to file an ANDS
referencing the impugned “innovative drug” as the reference product.
[19]
It is plain and obvious that the Minister’s decision
to list Avamys® on the Register does not
in anyway impact or prejudice CGPA or any of its members. GSK has clearly
established that CGPA has no standing to bring the application for judicial
review as a person “directly affected”.
Whether
CGPA has public interest standing
[20]
GSK also submits that CGPA does not have public interest standing
as it does not purport to speak on behalf of the public.
[21]
The three-part test for public interest standing
is set out by the Supreme Court of Canada in Canadian Council of Churches v.
Canada (Minister of Employment and Immigration), [1992] 1 S.C.R. 236
at 253, as follows:
(i)
Is there a serious
issue raised as to the validity of a public act exercised by a statutory
authority?
(ii)
Is the challenger
affected directly by the act or have a genuine interest in the validity of the
act in issue?
(iii)
Is there no other
reasonable or effective manner in which to bring the issue to Court?
[22]
For the purpose of this motion, I am prepared to
accept that the application raises a serious or justiciable issue.
[23]
However, as I have concluded above, CGPA is not
“affected directly” and has no “genuine interest” in the decision under review.
I agree with GSK that CGPA’s primary objective is to have the entire data
protection regime struck down as being ultra vires rather than to
challenge the Minister’s refusal to remove the listing of fluticasone furoate from
the Register.
[24]
The basic purpose of public interest standing is to ensure
that legislation is not immunized from challenge. Where there is no such
immunization “the very rationale for the public interest litigation party
disappears”: Canadian Council of Churches v. Canada
(Minister of Employment and Immigration), [1992] 1 S.C.R. 236 at
p. 256. The
Regulations specifically
allow for generic manufacturers to challenge the listing of “innovative drugs”
on the Register. This is the most reasonable and effective procedure to
challenge a listing in the Courts.
[25]
There
is no need to hear from a party whose rights are not directly affected based on
an alleged public interest. In fact, on the evidence before me, it appears that
the interests being advocated by CGPA are exclusively those of its members, and
not the public at large.
[26]
A challenge to the vires of the data
protection Regulations, unlike a challenge concerning a particular drug,
would be of interest to all generic manufacturers, thereby making CGPA an
appropriate representative party. However, in contrast, a specific
administrative decision, as in the present case, should only be challenged by
parties who are actually subject to the legal duties imposed by that particular
decision.
[27]
Since the present application pertains to a
particular drug, rather than the entire legislative scheme, it is plain and
obvious that the preferred, reasonable and effective manner to bring this issue
to the Court is by a generic drug manufacturer seeking to submit an ANDS for
fluticasone furoate.
Conclusion
[28]
This is an appropriate case for this Court to
exercise its discretion to make a preliminary determination of standing to
dismiss the application.
[29]
For all of the above reasons, it is plain and obvious
that CGPA has no standing and that the application is bereft of all possibility
of success. The Notice of
Application is accordingly struck out and the proceeding is dismissed, with
prejudice.
ORDER
THIS
COURT ORDERS that:
1.
The
motion is granted.
2.
The
Notice of Application is struck out and the application is dismissed.
3.
In
the event the parties are unable to agree on costs on the motion, the parties
are granted leave to serve and file written submissions, not exceeding 5 pages
in length.
“Roger
R. Lafrenière”
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