Date: 20100225
Docket: T-116-07
Citation: 2010 FC 213
Ottawa, Ontario, February
25, 2010
PRESENT: The Honourable Mr. Justice O'Keefe
BETWEEN:
HOSPIRA
HEALTHCARE CORPORATION
Applicant
and
ATTORNEY GENERAL OF CANADA
THE MINISTER
OF HEALTH
Respondents
PUBLIC REASONS FOR
JUDGMENT AND JUDGMENT
ISSUED FEBRUARY 25, 2010
O’KEEFE J.
[1]
This
is an application pursuant to section 18.1 of the Federal Courts Act,
R.S.C. 1985, c. F-7, for judicial review of the decision letter dated December
19, 2006, of the Therapeutic Products Directorate of Health Canada (or the
“Board”) which, on behalf of the Minister of Health, rejected a New Drug
Submission (NDS) filed by the applicant on the grounds that the NDS did not
comply with the requirements of the Food and Drug Regulations, C.R.C. c.
870, as amended (the Regulations).
[2]
The
applicant requests that:
1. Its
application be allowed with costs;
2. Health
Canada’s decision
to summarily reject the applicant’s NDS Control No. [omitted] be set aside;
3. A
Notice of Compliance (NOC) be issued to the applicant for [omitted], upon
satisfactory completion of a substantive review by Health Canada of the applicant’s
NDS for compliance with section C.08.002 (but excluding subsections (g) and
(h)), such review to be completed within 120 days of any order made herein;
4. In
the alternative to 3, Health Canada shall:
- Forthwith
process the applicant’s NDS, and
- Issue
an NOC with Conditions (NOC(C)) to the applicant for [omitted], upon
satisfactory completion of a substantive review by Health Canada of the
applicant’s NDS for compliance with section C.08.002 (but excluding
subsections (g) and (h));
- Convene
an advisory board to define the applicable conditions for the NOC(C);
- Ensure
that no member of the advisory board shall have had any involvement with
the decision to reject that is the subject of this judicial review
application; and
- Complete
such review within 120 days of any order made herein;
5. In the further
alternative to 3 and 4, that Health Canada:
i. Forthwith review the
Applicant’s NDS for compliance with section C.08.002;
ii. Convene
an advisory board for the purpose of defining pragmatic parameters for any supplemental
evidence in support of the safety and efficacy of [omitted];
iii. Allow
the applicant a full opportunity to respond, and;
iv. Ensure
that no member of the advisory board shall have had any involvement with the
decision to reject that is the subject of this judicial review application,
and;
v. Complete
such review within 120 days of any order made herein.
Background
[3]
A
New Drug Submission (NDS) is required for the regulatory approval and issuance
of a Notice of Compliance (NOC) by Health Canada. Once
received, an NOC allows the manufacturer to sell the drug in Canada. The NDS
contains scientific information about the product’s safety, efficacy and
quality. It includes the results of clinical studies, details on the production
of the drug and its packaging and labelling, and information about its claimed
therapeutic value, conditions for use and side effects.
[4]
The
drug which is the subject of the applicant’s NDS is called [omitted]. [Omitted].
The respondents do not dispute that [omitted] is widely used in western
countries and is now considered a “standard of care” drug for [omitted]. Even
though the respondent Minister did not issue an NOC for [omitted], the drug had
been available in Canada [omitted] through Health Canada’s Special
Access Programme (SAP). The SAP provides for the limited use of alternative drugs
when conventional drugs have failed, and involves Health Canada’s approval
for each usage.
[5]
In
2004, the applicant consulted with Health Canada about the prospects of the
applicant supplying [omitted] in Canada. In the absence of an
NOC for [omitted], Health Canada took the position that a regulatory
submission filed by the applicant would have to be an NDS, not an Abbreviated
NDS (ANDS). It was understood early on that the usual requirement for a
clinical trial for [omitted] would be hard to satisfy. The applicant viewed
clinical testing of [omitted] as unnecessary, [omitted]. In February of 2005,
the parties met again to discuss how the applicant might satisfy the
requirement of clinical trial data for [omitted].
[6]
In
May 2006, the parties met again. Despite the applicant’s evidence regarding the
safety and effectiveness of [omitted], Health Canada advised that
it would not accept an NDS for [omitted] where evidence of safety and
effectiveness was confined to literature submissions. The applicant alleges that
during these consultations, Health Canada undertook to define
criteria and specifications it would impose on [omitted] in lieu of requiring
full independent clinical testing. In other words, the applicant alleges that
Health Canada undertook to define, what I will refer to as an innovative NDS
for [omitted].
[7]
The
applicant alleges that Health Canada reneged on its commitment in a letter
dated August 17, 2006 wherein Health Canada reiterated that an NDS
for [omitted] must contain independent clinical trial data. In the letter,
Health Canada acknowledged
the “unique clinical environment of [omitted]” and contemplated the submission
of an innovative NDS, but explained that due to proposed legislative changes, [omitted]
the issuance of an NOC for the applicant’s [omitted].
[8]
Apparently,
Health Canada was
referring to the Data Protection Regulation, SOR/2006-241 (effective
October 5, 2006) and its knowledge that the original owners of [omitted] would
file an NDS soon after the Regulations come into force. The new Regulations
would then prevent a generic NOC for eight years.
[9]
Despite
the view expressed by Health Canada, the applicant filed an NDS for [omitted]
on October 27, 2006 on the strength of volumes of evidence available on the
safety and efficacy of [omitted]. The package of literature attempted to
satisfy all of Health Canada’s substantial concerns.
Health Canada’s Decision
[10]
In
a letter dated December 19, 2006, titled “Screening Rejection Letter”, Health Canada rejected the
applicant’s NDS for [omitted] without prejudice to the applicant’s ability to
refile. After screening the applicant’s material submitted, Health Canada determined
that the NDS did not comply with the requirements of the Regulations.
[11]
The
Board began by noting that NDS approval requires compliance with section
C.08.002 of the Regulations. The Board then noted that no pre-clinical or
clinical data had been provided with the NDS and that only literature
references and reports of postmarketing experience were provided.
[12]
The
Board noted that in previous consultations with the applicant, Health Canada had made it
clear that independent clinical trials would be necessary.
Procedural
History
[13]
The
applicant brought a motion to require the respondent Minister to produce
documents which had been identified in a Rule 317 request for production. The
motion was decided by the February 1, 2008 order of Prothonotary Aronovitch,
who granted the motion in part, but limited production to documents that were
relevant to the December 19, 2006 decision.
[14]
The
Prothonotary determined that Hospira could not seek to expand the grounds of
the present judicial review, in order to collaterally attack the August 17,
2006 decision of the respondent Minister not to allow or define an innovative
NDS. The Prothonotary held that the jurisprudence limits and defines documents
that are relevant in a judicial review to the record that was before the
decision maker at the time that he or she made the decision that is the subject
of the judicial review. With regard to the applicant’s request, she stated:
The allegations of breaches of procedural fairness are invoked in
respect of an extraneous manner, namely, the Minister's refusal to provide
criteria. To the extent that the applicant wishes to rely on the Minister's
refusal to do so, it has the wherewithal to establish the fact. The history and
substance of the discussions, or the Minister's conduct in that connection
however, are not relevant in the sense that they are extraneous to the relief
sought and will not assist the Court in determining the propriety of the
decision made on December 19, 2006.
[15]
The
applicant sought an order reversing the Prothonotary’s order.
[16]
In
Hospira Healthcare Corp. v. Canada (Attorney General), 2008 FC
355, [2008] F.C.J. No. 505 (QL) (Hospira I), Mr. Justice Beaudry refused
to reverse the Prothonotary’s order. Mr. Justice Beaudry agreed that the
decision of August 17, 2006 was a previous decision which could not be
collaterally attacked in the present judicial review. The applicant chose to
review Health Canada’s decision
of December 19, 2006 which did not include any conclusions as to the safety and
efficacy of [omitted]. The submission was rejected because no pre-clinical or
clinical data was provided, and as such, the NDS did not meet the requirements
of the Regulations.
Issues
[17]
The
applicant submitted the following issues for consideration:
1. What
is the standard of review?
2. Is
[omitted] a “new drug” within the meaning of section C.08.001 (a) of the Regulations?
3. Does
section C.08.002 of the Regulations mandate the submission of clinical trial
data as part of a New Drug Submission?
4. Was
Health Canada’s decision
reasonable?
5. Did
Health Canada breach its
duty of procedural fairness to the applicant?
[18]
The
applicant’s second issue bears no relation to the decision of December 19,
2006. Furthermore, Hospira I above, held that the applicant’s fifth
issue is extraneous to this judicial review. As such, I would rephrase the
issues as follows:
1. What
is the appropriate standard of review?
2. Does
s. C.08.002 of the Regulations mandate the submission of clinical trial data as
part of a New Drug Submission?
a. If
not, did the Minister fetter his discretion by strictly adhering to a policy of
requiring clinical trial data?
3. Was
Health Canada’s decision
reasonable?
4. Is
mandamus available as a remedy?
Applicant’s Written
Submissions
[19]
The
applicant submits that section C.08.002 does not use the words “clinical trial
data” or “pre-clinical”. Rather, the section allows for flexibility, giving the
Minister discretion to assess and determine whether the reports and evidence
tendered are sufficient to establish safety and efficacy. In addition, section C.08.003
allows the Minister to ask for supplemental information.
[20]
The
applicant submits that when a decision maker is granted discretion, it cannot
impede that discretion and then assert immunity from judicial review on the
basis that its exercise of discretion is entitled to deference (see Delisle
v. Canada (Attorney
General),
298 F.T.R. 1, [2006] F.C.J. No. 1230 (QL)).
[21]
The
applicant submits that Health Canada has interpreted section C.08.002 narrowly
and as a matter of policy, requires clinical trial data regardless of the
surrounding circumstances. A decision maker cannot rely on guidelines or policy
to sidestep its obligations to assess, on a case by case basis, relevant facts
and circumstances. If this occurs, the decision maker has fettered his
discretion (see Delisle above). Here, the summary rejection was a
blinkered adherence to policy.
[22]
The
applicant submits that to be reasonable, there must be justification,
transparency and intelligibility within the decision making process. The
decision lacks justification because it was premised on the rigid application
of policy.
[23]
The
applicant also submits that the decision appears to have been driven by a
bureaucratic motivation to avoid creation of precedent of deviating from its
policy. The applicant also alleges that Health Canada preferred to receive a
submission from [omitted] original owners. Such internal strategic motives
constitute an improper exercise of decision making power. While decisions based
on administrative convenience may be rational, they fail to meet the standard
of reasonableness (see Canadian Union of Public Employees (C.U.P.E.) v. Ontario (Minister of
Labour),
2003 SCC 29, [2003] 1 S.C.R. 539, [2003] S.C.J. No. 28 (QL)).
[24]
The
applicant submits that the decision also lacks intelligibility since Health Canada was aware
that conventional clinical trials for [omitted] could not be ethically
repeated. Requiring such clinical trials clearly contravenes the spirit and
purpose of the Regulations, which is to protect the health and safety of the
Canadian public.
[25]
The
applicant submits that the decision does not fall within the range of acceptable
outcomes. This is because it has resulted in a monopoly in [omitted] for the
original owners and has caused the price to double. The legislature could not
have intended the Regulations to be interpreted and applied in a manner that
would yield such a result. The framework of the Regulations allow three
alternative courses of action that would have avoided this outcome: (i) review
the NDS on a substantive basis and issue an NOC, (ii) review the NDS on its
merits and issue an NOC with conditions (an NOC(C)) whereby the applicant would
supply supplemental evidence of safety and efficacy, or (iii) review the NDS
and provide cogent, specific and pragmatic criteria for the additional evidence
required with respect to safety and efficacy and allow the applicant an
opportunity to respond.
Respondents’ Written
Submissions
[26]
The
respondents reiterate that the only decision under review is the December 19,
2006 decision by the Minister to reject the applicant’s NDS because clinical
and pre-clinical data required by the Regulations were absent. This Court has
already confirmed the narrow scope of this application for judicial review (See
Hospira I above)
[27]
The
respondents do not agree that the Minister has as much discretion as the
applicant suggests. In Apotex Inc. v. Canada (Attorney
General),
[1994] 1 F.C. 742, [1993] F.C.J. No. 1098 (C.A.) (QL);
affirmed [1994] 3 S.C.R. 1100 (Apotex), the Minister’s discretion under
the Regulations was described as “narrowly circumscribed”. The applicant here
suggests that the Minister may or should take into account in exercising his
discretion, factors such as costs and competitive conditions, which are not
related to safety and effectiveness and thus should not influence the Minister
in determining how to exercise his narrowly circumscribed discretion.
[28]
Subsections
C.08.002(2)(g) and (h) clearly state that clinical tests are required to be
made in respect of a new drug, and an NDS is required to contain information
about those tests that satisfy the Minister that the new drug is safe and
effective. The phrase in (h) “substantial evidence of the clinical
effectiveness of the new drug” can only refer to data showing the results of
clinical tests designed and conducted to demonstrate the drug’s effectiveness.
The applicant’s NDS did not contain such information and accordingly it was
rejected.
[29]
The
respondents submit that even if clinical data is not explicitly required by the
legislation, the Minister’s determination that it is implicitly required
certainly merits deference. The Minister is permitted to make determinations
that fall within a range of acceptable outcomes. Requiring clinical tests is
particularly reasonable since legislators specified that the information must
be sufficient to enable the Minister to assess the drug’s safety and
effectiveness. The applicant appears to acknowledge the correctness of the
Minister’s interpretation of the legislative requirement. In particular, the
applicant seeks to have the Court order the Minister to review its submission
“for compliance with section C.08.002 (but excluding subsections (g) and (h))”.
[30]
The
respondents submit that the applicant has failed to satisfy the conditions for
the granting of mandamus. Namely, the applicant failed to show that it
has a clear right to the performance of a public legal duty owed to the
applicant at the time of the hearing. The applicant has not drawn the Court’s
attention to a single case in which mandamus has required the Minister
to issue an NOC where the Minister was not satisfied that the drug was safe and
effective. Nor has the applicant shown that the Minister owes any duty to
conduct any review in accordance with specified conditions. Nothing in the
legislation permits the Minister to overlook sections C.08.002(2)(g) and (h) as
the applicant asks. An order of mandamus cannot compel an officer to act
in a specified manner if he or she is not under an obligation to act as of the
hearing date.
[31]
The
respondents finally submit that mandamus is above all a discretionary
remedy and that a judge can refuse to grant mandamus where potential
health and safety risks outweigh an individual’s right to pursue personal or
economic interests (Apotex above, at paragraph 101).
Analysis and
Decision
[32]
Issue
1
What is
the appropriate standard of review?
The parties
agree that the appropriate standard of review is reasonableness. There is a
presumption that reasonableness will be the appropriate standard, especially
where the issue is one of fact, discretion or policy. Deference will also be
shown where the decision maker is interpreting and applying its own statute or
statutes closely affected to its function (see Dunsmuir v. New Brunswick,
2008 SCC 9, [2008] 1 S.C.R. 190, [2008] S.C.J. No. 9 (QL), Canada (Citizenship
and Immigration) v. Khosa, 2009 SCC 12, [2009] S.C.J. No. 12 (QL), at
paragraph 25).
[33]
Previous
jurisprudence of this Court has found that decisions of Health Canada on
questions of fact and the exercise of discretion falling within Regulations
(Part C) are entitled to deference (see Canadian Pharmaceutical Technologies
International (C.P.T.) Inc. v. Canada (Attorney General), 2006 FC 708,
[2006] F.C.J. No. 906 (QL) at paragraphs 11 to 17). Indeed, the safety and
effectiveness of new drugs is an issue Parliament has confided to the Minister.
Thus, reasonableness is the appropriate standard for both the Minister’s
interpretation of the Regulations as well as the Minister’s ultimate decision
regarding the applicant’s NDS.
[34]
Issue
2
Does
section C.08.002 of the Regulations mandate the submission of clinical trial
data as part of a New Drug Submission?
The
Appropriate Scope of this Review
There is
some dispute as to the scope of this judicial review. While the applicant
wishes to review the decision of December 2006 rejecting its NDS, it also
wishes to review Health Canada’s prior determination that [omitted] was a
“new drug” as defined by the Regulations. The applicant also implicitly
attempts to collaterally attack Health Canada’s decision
of August 19, 2006 not to define specific criteria for the applicant’s NDS for [omitted]
and instead to revert to its standard policy of requiring independent clinical
trials. The respondents argue that this application should be limited to a
review of the decision made in December 19, 2006.
[35]
In
my opinion, the scope of this judicial review is properly confined to the
December 19, 2006 decision. Indeed, this Court has already ruled on this matter
in Hospira I where Mr. Justice Beaudry upheld the Prothonotary’s
determination that documentation relating to Health Canada’s August 17,
2006 decision, the safety and efficacy of the drug, and the drug’s eligibility
for the SAP was irrelevant to the December 19, 2006 decision. The Prothonotary
stated:
… having chosen to impugn one decision
the applicant, in my view, cannot rely on the grounds of review to expand the
scope of the decision, to graft other decisions on to it, or use the grounds of
review of an impugned decision to collaterally attack another.
…
The allegations of breaches of procedural
fairness are invoked in respect of an extraneous matter…
Although I am not bound
by the prior decisions, I am in agreement with the decisions and I accept their
conclusions.
[36]
I
turn now to the decision of December 19, 2006 (the NDS rejection). In the NDS
rejection letter, Health Canada states that the NDS was rejected at the
screening stage due to a failure on the applicant’s part to comply with the
Regulations. It then states that no pre-clinical or clinical data were included
and that only literature submissions were included. It read in relevant part:
In accordance with the Management of
Drug Submissions guidance, Section 5.4.2, this is to notify you that the
New Drug Submission, for [omitted] is considered rejected without
prejudice to a refilling.
After the screening of the information
and material submitted, it has been determined that the submission does not
comply with the requirements of the Food and Drug Regulations. The following
issues or concerns have not been resolved:
1. … no pre-clinical or clinical data
was provided…
[37]
I
will refer to the precise enactments relevant to this application. Part C of
the Food and Drug Regulations deals with drugs. Section C.08.002 reads
as follows:
C.08.002. (1) No person shall sell or
advertise a new drug unless
(a) the manufacturer of the new drug
has filed with the Minister a new drug submission or an abbreviated new drug
submission relating to the new drug that is satisfactory to the Minister;
(b) the Minister has issued, pursuant to
section C.08.004, a notice of compliance to the manufacturer of the new drug in
respect of the new drug submission or abbreviated new drug submission;
(c) the notice of compliance in respect
of the submission has not been suspended pursuant to section C.08.006; and
(d) the manufacturer of the new drug has
submitted to the Minister specimens of the final version of any labels,
including package inserts, product brochures and file cards, intended for use
in connection with that new drug, and a statement setting out the proposed date
on which those labels will first be used.
(2) A 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:
…
(g) detailed reports of the
tests made to establish the safety of the new drug for the purpose and under
the conditions of use recommended;
(h) substantial evidence of
the clinical effectiveness of the new drug for the purpose and
under the conditions of use recommended;
…
(my emphasis)
[38]
The
NDS rejection makes it clear that in Health Canada’s view the
Regulations require pre-clinical and clinical data to be submitted with an NDS.
The respondent Minister maintains this position and submits that even if the
Regulations do not explicitly require pre-clinical and clinical data, they do
so at least implicitly.
[39]
In
contrast, the applicant asserts that section C.08.002 does not require data
from pre-clinical and clinical trials. Rather, an NDS need only contain, under
C.08.002(2)(g), “detailed reports” of the tests made to establish safety and,
under C.08.002(2)(h), “substantial evidence” of clinical effectiveness. The
applicant argues that the plain words of the Regulations give the Minister a
considerable degree of flexibility regarding what the Minister can accept as
evidence of a new drug’s safety and effectiveness. It asserts that this grant
of discretionary flexibility was improperly fettered by Health Canada’s policy of
requiring pre-clinical and clinical data.
[40]
No
judicial consideration of the above sections was referred to by either the
applicant or respondents.
[41]
Dunsmuir above,
teaches that the standard of reasonableness and the concept of deference
extends to a tribunal’s interpretation of its constitutive or related
enactments. In Khosa above, Mr. Justice Binnie enunciated this
principle:
[25] … Dunsmuir recognized that
with or without a privative clause, a measure of deference has come to be
accepted as appropriate where a particular decision had been allocated to an
administrative decision maker rather than to the courts. This deference
extended not only to facts and policy but to a tribunal's interpretation of its
constitutive statute and related enactments because "there might be
multiple valid interpretations of a statutory provision or answers to a legal
dispute and that courts ought not to interfere where the tribunal's decision is
rationally supported" (Dunsmuir, at para. 41). A policy of
deference "recognizes the reality that, in many instances, those working
day to day in the implementation of frequently complex administrative schemes
have or will develop a considerable degree of expertise or field sensitivity to
the imperatives and nuances of the legislative regime" (Dunsmuir,
at para. 49, quoting Professor David J. Mullan, "Establishing the Standard
of Review: The Struggle for Complexity?" (2004), 17 C.J.A.L.P. 59, at p.
93). …
[42]
In
regard to applying the reasonableness standard to a question of statutory
interpretation Mr. Justice Binnie added:
[44]… Dunsmuir (at para. 54), says
that if the interpretation of the home statute or a closely related statute
by an expert decision maker is reasonable, there is no error of law justifying
intervention….
(my emphasis)
[43]
In
my opinion, while the applicant’s interpretation of the Regulations may have
merit, the respondent Minister’s view that pre-clinical and clinical data is
implicitly required, is certainly a reasonable interpretation of the
Regulations that falls within the range acceptable outcomes.
[44]
The
Minister’s view that pre-clinical and clinical data are required is
strengthened when one considers that the legislators specified that the
information must be sufficient to allow the Minister to assess the safety and
efficacy.
[45]
Indeed,
the applicant appears to acknowledge the reasonableness of the Minister’s
interpretation of the Regulations. In its notice of application, the applicant
seeks to have this Court order the Minister to review its NDS “for compliance
with section C.08.002 (but excluding subsections (g) and (h))”. Clearly, the
applicant seeks an exemption from what can be considered the plain requirements
of section C.08.002(2)(g) and (h), likely knowing that without such exemption,
its NDS could not be considered satisfactory.
[46]
Therefore,
the impugned decision should stand and should not be interfered with on the
application of the reasonableness standard to the Minister’s interpretation of
its home statute and related regulations.
[47]
While
this appeal can be disposed of on the determination that the Minister
interpreted the Regulations reasonably, I will go on to examine the merits of
the applicant’s further arguments. In particular, I believe that the narrative
of this case requires an analysis of the applicant’s procedural concerns
regarding the fettering of the Minister’s discretion.
[48]
Even
if the Minister’s interpretation that pre-clinical and clinical data are
required is unreasonable, the Regulations at least allow the Minister the
discretion to request that clinical data be provided with an NDS. The applicant
asserts that the Minister fettered this discretion by requiring clinical data
in all cases as a matter of policy, and without regard to the applicant’s
circumstances.
[49]
Nonetheless,
the applicant submits that when a decision maker is granted discretion, it
cannot impede that discretion with a policy it treats as binding upon itself.
If this occurs, the decision maker has fettered his discretion (see Delisle above).
[50]
To
state a general administrative principle, an administrative board or tribunal
may not fetter the exercise of its statutory discretion by mechanically
applying an internal policy. The issue is not whether the policy was a factor
in the decision, but whether the decision maker treated the policy as binding
or conclusive, without the need to consider any other factors, including
whether or not it should apply to the unique circumstances of the particular
case (See Brown, Donald J. M. and John M. Evans, “Judicial Review of
Administrative Action in Canada”, Toronto: Canvasback, 1998 (loose-leaf updated
July 2008 at 12:44).
[51]
In
Delisle above, several patients sought to review a decision that a director
under Health Canada’s SAP had
made. The decision implemented a change in policy, under which SAP’s access to
a particular drug would become phased out. Mr. Justice Lemieux held that the
Regulations gave the director considerable discretion to issue authorizations
for special access on a case by case basis. The new policy unlawfully fettered
that discretionary power because, even though it would allow the access to the
drug in certain circumstances, it did not allow for the consideration of
humanitarian concerns and it effectively barred any new patients from accessing
the drug. In Mr. Justice Lemieux’s opinion, the implementation of a change in
SAP policy was confined within the bounds of the balance Parliament had
attempted to strike with the creation of the SAP program. (see Delisle
at paragraph 173).
[52]
In
Apotex Inc. v. Canada (Minister of Health), 2009 FC
452, [2009] F.C.J. No. 577 (QL) (Apotex 2009) Mr. Justice Phelan dealt
with a similar issue. Apotex’s ANDS for aspirin had been rejected by the
Minister because the data from two of its clinical test subjects did not meet
the Minister’s standards, reflected in Health Canada’s
guidelines. Apotex defended its drug, asserting that the defective reference
drug caused the errors. One year later, on reconsideration, Health Canada confirmed
the rejection. Apotex then charged that the Minister had fettered his
discretion by rigidly adhering to his guidelines. Mr. Justice Phelan disagreed
and held first that the published guidelines allowed for exceptions and second,
that the Minister analyzed Apotex’s submissions and specifically explained its
concerns. At paragraph 35 he stated:
It is not unreasonable, nor is it
intransigence, for the Minister to demand compliance with the Guidelines in the
absence of a clear indication that an alternative approach is required.
[53]
In
the present case, the record makes it apparent that the decision to require the
applicant to provide clinical data (if clinical data was not required by the
Regulations) was not made on December 19, 2006, but was made prior to Health
Canada’s letter issued on August 17, 2006. As discussed above, the applicant
cannot attack the August 17, 2006 decision in this judicial review, because as
noted in Hospira I, the August 17, 2006 and December 19, 2006 decisions
were discrete and separate decisions.
[54]
Even
if the August 17, 2006 decision and the December 19, 2006 are viewed as being
so intertwined as to be reviewed together, the claim that the Minister fettered
his discretion cannot be accepted. It is clear from the record that, like Apotex
2009 above, the particular circumstance of the applicant was considered
extensively before the Minister finally decided that it would apply its policy
to require clinical data. The applicant alleges that it was in consultations
with Health Canada for 22
months to determine if alternative criteria could be accepted in its NDS. In
the end, Health Canada decided it would not define or accept such
alternative criteria. It is not open for the applicant to now argue its
particular circumstances were not taken into account, or that the Minister was
legally obliged to make an exception.
[55]
Nor
was there a breach in procedural fairness since requiring clinical data was
Health Canada’s normal
procedure, and the applicant was given explicit and sufficient notice that
clinical data would be required, prior to the submission of its NDS.
[56]
Issue
3
Was the
respondent Minister’s decision to reject the applicant’s NDS reasonable?
The
applicant argues the decision was unjustified because it relied on a rigid
adherence to policy. In reality, the decision was based on the applicant’s
failure to comply with the Regulations, and is easily justified on that basis.
[57]
The
applicant argues that the decision lacked transparency because it was based on
internal motives. This argument however refers to the August 17, 2006 decision,
which again is not part of this review. The applicant has not discussed how the
December 19, 2006 decision lacked transparency.
[58]
The
applicant argues the decision lacks intelligibility since Health Canada knew that
requiring clinical data for [omitted] would be problematic. Again, this
argument seeks to attack the August 17, 2006 decision to require clinical data
for [omitted].
[59]
Finally,
the applicant argues that the decision falls outside the range of acceptable
outcomes because it has resulted in the original owners of [omitted] getting a
monopoly on the drug’s distribution in Canada, causing the
price to double.
[60]
I
do not find that this outcome is beyond the range of acceptability. While some
aspects of monopolies are undesirable, Parliament, with the enactment of the Food
and Drug Regulations, must have considered and accepted the possibility
that some decisions of Health Canada could result in such monopolies.
[61]
Because
of my findings above, I need not deal with whether mandamus would have
been available as a remedy.
[62]
The
application for judicial review is therefore dismissed, with costs to the
respondents.
JUDGMENT
[63]
IT
IS ORDERED that the application for judicial review is dismissed, with costs
to the respondents.
“John
A. O’Keefe”
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