Date: 20080320
Docket: T-116-07
Citation: 2008 FC
355
Ottawa, Ontario, March 20, 2008
PRESENT: The Honourable Mr. Justice Beaudry
BETWEEN:
HOSPIRA
HEALTHCARE CORPORATION
Applicant
and
ATTORNEY GENERAL OF CANADA
THE MINISTER OF HEALTH
Respondents
AMENDED REASONS FOR ORDER AND ORDER
(according to the Protective Order issued
by
Justice Mactavish on August 14, 2007)
AMENDING THE REASONS FOR ORDER
AND ORDER ISSUED ON
MARCH 18, 2008, WHICH ARE NOW
CONFIDENTIAL
[1]
This is an
application by Hospira Healthcare Corporation (Hospira) for an order reversing
the February 1, 2008 Order of Prothonotary Aronovitch, to the extent that it
declined to order that the respondent Minister of Health (Minister) produce the
documents requested by Hospira pursuant to Rule 317.
ISSUES
[2]
Hospira submits
the following issues to be determined in the present case:
a) Did the prothonotary fail to
assess the relevance of the documents sought with reference to the grounds of
judicial review?
b) Did the prothonotary err in
failing to recognize that the decision to reject Hospira’s NDS is not severable
from the events that preceded it, namely Hospira’s ongoing dealings with the
Minister with respect to regulatory criteria for Drug A?
c) Did the prothonotary err in
misapplying the test for production under rule 317, where procedural fairness
is alleged?
[3]
The issues
can be restated as a single issue: did the prothonotary refuse the motion based
upon a wrong principle or a misapprehension of the facts?
BACKGROUND
[4]
The
underlying application for judicial review challenges the respondent Minister’s
refusal to consider a New Drug Submission (NDS) that was filed by Hospira,
seeking a notice of compliance (NOC) for Drug A. The respondent Minister’s
decision was based on the fact that the NDS did not provide clinical trial data
to establish the safety and efficacy of Drug A pursuant to the Food and Drug
Regulations, C.R.C., c. 870.
[5]
Drug A has
been supplied through the Special Access Programme (SAP) since approximately
1999, for the treatment of Drug A Indications. Because Drug A came into common
use as the treatment for Drug A Indications, Hospira could not have conducted
the usual clinical trials or generated data required by the Food and Drug
Regulations to establish safety and efficacy without significant ethical
concerns.
[6]
Prior to
the respondent Minister’s decision of December 19, 2006 in a “Screening
Rejection Letter”, discussions were undertaken between Health Canada and Hospira
over a period of some twenty-two months. Health Canada allegedly undertook to Hospira that it
would define criteria and specifications with respect to the evidence required
to establish the safety and efficacy of Drug A that would respect the unique
clinical environment of the drug. Once established, Hospira could then adopt the
criteria and specifications in seeking an NOC.
[7]
By a
letter dated August 17, 2006, Health Canada
allegedly reneged on its commitment and declined to provide Hospira with the pragmatically
defined safety and efficacy specifications as discussed. Hospira proceeded to
file its NDS in the absence of specially defined safety and efficacy criteria
on October 27, 2006.
[8]
Following
the Minister’s Screening Rejection Letter on December 19, 2006, Hospira filed
an application for Judicial Review. Hospira brought a motion to require the
respondent Minister to produce documents which had been identified in the Rule
317 Request for Production. The motion was decided by the February 1, 2008
Order of Prothonotary Aronovitch, who granted the motion in part.
[9]
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 specially define safety and
efficacy criteria.
[10]
Prothonotary
Aronovitch’s reasons relating to the scope of documents which can be produced
under Rule 317 can be summarized by reference to the following paragraphs of
the Order:
The applicant’s request for production
under Rule 317 is expansive. It spans seven pages and essentially asks for the
production of any and all material, of any kind, that Health Canada may have
relating to the drug at issue.
…
With few exceptions, 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. That record has been
provided to the applicant. I will open a parenthesis here to say that the
record that has been produced to the applicant makes reference to the minutes
or summaries of various meetings some which are said to be attached. There is
no doubt that these constitute part of the “tribunal record” and have to be
produced, if they have not already been produced.
With that caveat, I find no reason in
these circumstances to derogate from the general principle that the record be
limited to what was before the decision-maker when the NDS was rejected. There
is no basis to expand on the documents to be produced. 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.
ANALYSIS
Standard of Review
[11]
Discretionary
orders of prothonotaries ought not to be disturbed unless they are clearly
wrong, in the sense that the exercise of discretion was based upon a wrong
principle or a misapprehension of the facts, or where discretion was improperly
exercised on a question vital to the final issue of the case (Merck &
Co. v. Apotex Inc., [2003] F.C.J. No. 1925, 2003 FCA 488).
[12]
The
parties agree that the question raised by this appeal is not vital to the final
issue of the case, and as such the decision will only be disturbed if it was
clearly wrong, as described above.
Relevance of documents sought was properly
decided
[13]
Hospira
submits that the question before the prothonotary was whether the documents
sought were relevant to the grounds of judicial review, as pleaded. It argues
that the prothonotary applied the wrong test and disregarded the grounds
pleaded by characterising the decision under review as being distinct from the
circumstances that lead up to the decision. Specifically, Hospira submits that
when the grounds of review include questions of procedural fairness, the
principle that Rule 317 production is limited to documents before the tribunal,
does not apply.
[14]
For its
part, the respondent Minister submits that the scope of Hospira’s request for production goes well
beyond what is provided by Rule 317. The Minister submits that a judicial
review differs from an appeal or an action, in which cases the more expansive
procedure of discovery might be allowed. In an application for judicial review,
the purpose of Rules 317 and 318 is to ensure that the record considered by the
decision maker is before the Court (Canada v. Pathak, [1995] 2 F.C. 455
(C.A.)).
[15]
The
Minister argues that Hospira attempts to have documents produced by the Minister
that relate to the August 17, 2006 decision, the safety and efficacy of the
drug, and the drug’s eligibility for the SAP, whereas the application before
the Court is limited to the decision communicated by letter dated December 19,
2006.
[16]
It is my
opinion that the prothonotary did not rely on a wrong principle when she
determined that the decision of August 17, 2006 was a previous decision which
could not be collaterally attacked by the present application for judicial
review. If the Minister failed to address an expectation that safety and
efficacy criteria would be provided, this argument should have been made in a
review of the August 17, 2006 decision. Hospira may not expand the scope of the
documents that are the subject of a request for production by alleging grounds
for judicial review which are unrelated to the decision being challenged.
[17]
I agree
with the Minister’s submission that the safety and efficacy of the drug are not
at issue in the underlying application for judicial review; the Screening
Rejection Letter dated December 19, 2006 did not include any conclusions as to
the safety and efficacy of Drug A. Rather, 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 Food and Drug Regulations.
[18]
For the
foregoing reasons, I find no reason to conclude that the prothonotary’s Order
was clearly wrong, in the sense that the exercise of discretion was based upon
a wrong principle or a misapprehension of the facts. Accordingly, this appeal
will be dismissed.
ORDER
THIS COURT ORDERS that the application for an order
reversing the Prothonotary’s Order, dated February 1, 2008 is dismissed. Costs
in the cause.
“Michel
Beaudry”
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