Date: 20100528
Dockets: T-1537-07 and T-706-10
Citation: 2010 FC 573
BETWEEN:
WELLESLEY
THERAPEUTICS INC.
Applicant
-
and -
MINISTER OF HEALTH (HEALTH CANADA),
DIRECTOR GENERAL THERAPEUTIC
PRODUCTS
DIRECTORATE (HEALTH CANADA) and ATTORNEY
GENERAL OF CANADA
Respondents
REASONS FOR
JUDGMENT
HUGHES J.
[1]
The reasons pertain to two applications for judicial review
that are closely related. They are brought by the same Applicant, Wellesley
Therapeutics Inc., against the same Respondents, Minister of Health (Health
Canada), Director General Therapeutic Products Directorate (Health Canada) and Attorney General of Canada, whom I will collectively
refer to as Health Canada.
The common issue is the refusal by Health Canada to grant permission to Wellesley to market in Canada a drug containing as an active ingredient a compound known as
disulfiram. For the reasons that follow, I will dismiss application T-706-10
and allow application T-1537-07 each with costs to the prevailing party fixed
at $3500.00.
[2]
Disulfiram is a drug that is used in the treatment of
alcoholics. Given under medical supervision, it has the effect of making the
patient very sick if the patient consumes alcohol. Given in small doses it
produces a massive hangover and thus serves as a deterrent to the consumption
of alcohol. Large doses taken under unsupervised conditions have been reported
to result in death. This drug was approved for sale by Health Canada and sold by a company named Wyeth under the brand name ANTABUSE
for a period from 1949 to 2001. It was withdrawn from the Canadian market in
2001. The reason for this withdrawal appears to be unclear on the record but
does not appear to be related to safety or efficacy of the drug. This drug
continues to be sold in over twenty-five other countries, including the United States of America. It also continues to be
available in Canada in a very limited fashion
through specialty compounding pharmacies. Such limited availability means that
the drug is generally not covered by provincial or federal insurance schemes
except in some circumstances in British Columbia; thus, the user must pay the full cost of the drug.
[3]
There are two other drugs approved for use in the treatment
of alcoholism in Canada; naltrexone
and acamprosate. They work by a different mechanism in that they reduce cravings
for alcohol and the euphoric feeling that alcohol produces.
[4]
The Applicant, Wellesley, is a small privately held
company, established in 2001. Its president is Dr. Willem Wassenaar, a
physician and who has occupied senior positions with several Canadian
pharmaceutical companies. He became familiar with the use of disulfiram in the
treatment of alcoholism while working as a clinical physician. He believes that
disulfiram is important as one of the several tools available to a physician in
such treatment. When Wyeth withdrew its disulfiram product ANTABUSE from the Canadian market in 2001, Wellesley began to
take steps to seek approval from Health Canada to reintroduce the product in the Canadian market. It chose the brand
name ABSTAYNE for that purpose.
SELLING A DRUG IN CANADA
[5]
The
sale of drugs in Canada is regulated by a federal statute, the Food
and Drugs Act, R.S.C. 1985, c. F-27 and the Food and Drug Regulations,
C.R.C., c. 870. A drug is defined in section 2 of that Act to include
any substance sold for use in the diagnosis, treatment, mitigation or
prevention of a disease, disorder or abnormal physical state.
“drug” includes any substance or mixture
of substances manufactured, sold or represented for use in
(a)
the
diagnosis, treatment, mitigation or prevention of a disease, disorder or
abnormal physical state, or its symptoms, in human beings or animals,
(b)
restoring,
correcting or modifying organic functions in human beings or animals, or
(c)
disinfection
in premises in which food is manufactured, prepared or kept;
[6]
Part
C, Division 1 of the Regulations, section C.01.014 prohibits the sale of
a drug in dosage form unless it has received and retains a Drug Identification
Number (DIN) from the Minister of Health who for the purpose administering the
relevant portions of the Act and Regulations operates through the
Therapeutic Products Division (TPD) of Health Canada:
C.01.014. (1) No manufacturer shall
sell a drug in dosage form unless a drug identification number has been
assigned for that drug and the assignment of the number has not been cancelled
pursuant to section C.01.014.6.
[7]
A
party may apply for a DIN directly, in which case it must submit certain
information as specified in section C.01.014.1 of the Regulations. This
information includes such things as labelling, pharmaceutical form and other
things, but nothing that is directly related to the safety or efficacy of the
drug.
C.01.014.1. (1) A manufacturer of a
drug, a person authorized by a manufacturer or, in the case of a drug to be
imported into Canada, the Importer of the drug may
make an application for a drug identification number for that drug.
(2) An application under subsection (1)
shall be made to the Director in writing and shall set out the following
information:
...
[8]
A
party may, alternatively, apply by making a “new drug submission” (NDS) or
“abbreviated new drug submission” (ANDS) which is deemed by section C.01.014.1
(3) also to be a DIN submission:
(3) In the case of a new drug, a new
drug submission or an abbreviated new drug submission filed pursuant to section
C.08.002 or C.08.002.1 shall be regarded as an application for a drug
identification number.
[9]
A
“new drug” is defined in section C.08.001 of the Regulations to be a
drug that “has not been sold in Canada for
sufficient time and in sufficient quantity to establish its safety and
efficacy”:
C.08.001. For the purposes of the Act
and this Division, “new drug” means
(a) a drug that contains or consists of
a substance, whether as an active or inactive ingredient, carrier, coating,
excipient, menstruum or other component, that has not been sold as a drug in
Canada for sufficient time and in sufficient quantity to establish in Canada
the safety and effectiveness of that substance for use as a drug;
(b) a drug that is a combination of two
or more drugs, with or without other ingredients, and that has not been sold in
that combination or in the proportion in which those drugs are combined in that
drug, for sufficient time and in sufficient quantity to establish in Canada the
safety and effectiveness of that combination and proportion for use as a drug;
or
(c) a drug, with respect to which the
manufacturer prescribes, recommends, proposes or claims a use as a drug, or a
condition of use as a drug, including dosage, route of administration, or
duration or action and that has not been sold for that use or condition of use
in Canada, for sufficient time and in sufficient
quantity to establish in Canada the safety and effectiveness of that use or condition of
use of that drug.
[10]
In
the case of a “new drug” it may not be sold in Canada unless it
has received a Notice of Compliance (NOC) as provided by section C.08.002 of
the Regulations.
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;
[11]
Such
Notices of Compliance are familiar to those dealing in the patent area; fortunately,
no patents are involved in the present applications.
[12]
Unlike
a simple DIN application, in order to obtain an NOC by way of a New Drug
Application a party must provide sufficient information to the Minister (Health
Canada) to enable
an assessment as to the safety and effectiveness of the drug, including any
testing as to safety and evidence of clinical effectiveness. Section C.08.002
(2) of the Regulations provides, inter alia:
(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.
[13]
Thus,
an application for approval to sell a drug in Canada is
considerably easier if the DIN only route can be followed. However, if the
drug is considered to be a “new drug”, then the NDS route leading to an NOC
(and DIN) must be followed. The principal difference is that a simple DIN
application alone does not require proof of safety and efficacy.
[14]
The
evidence of Dr. Petersen, a Division Manager in the Therapeutics Products
Directorate (TPD) of Health Canada,(her affidavit paragraph 20) is that when an
application for a DIN is received, the department makes an initial assessment
as to whether the drug is a “new drug”, if it is determined that the drug is a
“new drug” then the application is diverted and must follow the more rigorous
approval process. Guidelines published by TPD state:
A New Drug Status decision will be made
on all DIN submissions. When the drug product is considered to be in New Drug
Status, the applicant will be so informed, otherwise the DIN submission
evaluation will proceed.
A list of products currently regulated as
New Drugs has been prepared. Although the list will not be all-encompassing due
to the complexity of Division 8 of the Food and Drug Regulations, it is
intended to assist applicants in identifying many new drugs.
[15]
Dr.
Petersen, at paragraphs 19 and 21 of her affidavit, exemplifies such things as
fluoride toothpaste, sunscreen lotions, disinfectants and anti-dandruff
shampoos as those things defined as “drugs” that would normally be processed
directly through the DIN process without requiring a
New Drug Submission. Health Canada’s Counsel,
in the Memorandum of Argument filed in T-1537-07, puts it somewhat differently
at paragraph 70, where Counsel says:
“…a “DIN submission under Division 1,
which is the required route to approval for all products other than “new
drugs”.
[16]
Dr.
Petersen admitted during cross-examination Questions 40 to 45 that a
non-exhaustive list of drugs considered as “new drugs” was published by TPD and
that list did not include disulfiram. She had limited knowledge as to this list.
[17]
Under
section C.01.014.6(1)(b) of the Regulations, the Minister has the power
to cancel a DIN that has been assigned if the NOC has been suspended by the
Minister under section C.08.006 (2) of the Regulations. The Minister
has the power to suspend an NOC that had been issued, if, for instance, the
Minister has new information giving reason to believe the drug is not safe:
(2) The Minister may, by notice to a
manufacturer, suspend, for a definite or indefinite period, a notice of
compliance issued to that manufacturer in respect of a new drug submission or
an abbreviated new drug submission or a supplement to either submission, if the
Minister considers
(a) that the drug is not safe for the
use represented in the submission or supplement, a shown by evidence obtained
from
(i)
clinical
or other experience not reported in the submission or supplement or not
available to the Ministry at the time the notice of compliance as issued, or
(ii)
tests
by new methods or tests by methods not reasonably applicable at the time the
notice of compliance was issued
(b) that, upon the basis of new
information obtained after the issuance of the notice of compliance, there is
lack of substantial evidence that the drug will have the effect it is
represented to have under the conditions of use prescribed, recommended or
proposed by the manufacturer;
HISTORY
OF WELLESLEY’S APPLICATIONS
[18]
Wellesley submitted
its first application for its disulfiram product ABSTAYNE in the form of a DIN
application in 2002. Health Canada rejected this application on the basis
that the product was in the form of a powder which Health Canada did not
consider to be in final dosage form. Health Canada advised that
a DIN could only be issued for a product that did not require additional
processing before administration. This decision is not at issue.
[19]
Wellesley
reformulated its product in capsule form and, at the suggestion of Health Canada, filed its
application as a New Drug Submission (NDS) on August 10, 2006. In support of
this application it submitted information from the intended manufacturer, and updated
scientific literature as to disulfiram. By letter dated October 10, 2006,
Health Canada responded
with a Screening Deficiency Notice raising a number of issues, many of which
were addressed by Wellesley. On December 27, 2006, Health Canada sent a
Screening Rejection Letter to Wellesley stating that the
results of “a well designed and conducted clinical trial are
required. Literature references are not acceptable.” Wellesley was invited
to seek a reconsideration through an internal process established by Health Canada, which it
did, by letter dated January 26, 2007.
[20]
Health
Canada conducted a reconsideration of the matter and, by letter dated July 23,
2007, advised Wellesley that it
stood by its original decision to reject the application. The letter stated, in
part:
Upon reconsideration, the
Directorate stands by the original decision that the Abstayne submission, which
is based on information from the literature, does not constitute sufficient
evidence of safety and effectiveness for disulfiram. There are two products
currently on the market in Canada for this treatment of alcohol abuse since disulfiram was
first introduced and it is the regulator’s responsibility to assess the
risk/benefit of disulfiram in the current Canadian context. The Bureau of
Cardiology, Allergy and Neurological Science is willing to discuss the
requirements of a new NDS.
[21]
In
addition to this letter, Health Canada provided to Wellesley a
document entitled “Issue Analysis” which was a detailed response to a variety
of issues raised by Wellesley during the course of its submissions. In effect
these were reasons for the rejection. This rejection is the subject of the
first of these applications, T-1537-07.
[22]
On
November 16, 2007, Wellesley submitted a new DIN application for its
disulfiram product in capsule form. It submitted four volumes of technical
material, the record from the NDS application, and a number of other materials,
including product monographs of two other drugs. No results of any clinical
testing as such were submitted.
[23]
By
letter dated March 29, 2010, Health Canada provided its decision
to Wellesley respecting
this DIN application, together with a lengthy document entitled “Issue
Analysis” in which the
analysis of the issues was provided. The
DIN application was rejected. Again these were in effect the reasons for the
rejection. The letter stated, in part:
We regret to inform you that a
Drug Identification Number (DIN) for Abstayne (Control#118378) will not be
issued at this time since the product is considered to be a New Drug as defined
in Division 8 of the Canadian Food and Drugs Regulations.
Please refer to the following
enclosed documents that further express the reasoning behind the Therapeutic
Products Directorate’s decision:
Status of Disulfiram – Issue
Analysis
Appendix 1 – Letter to Dr.
Sandu Goldstein
Appendix 2 – Clinical Study
Reports
Appendix 3a – Interpretation
of Adverse Reaction Line-Listings
Appendix 3b – Summary of Canadian
Reported Adverse Reactions (Disulfiram)
Appendix 4 – Literature Search Results
for safety of Disulfiram
Products containing
disulfiram are considered to be New Drugs, as defined in Division 8 of the
Canadian Food and Drugs Act and Regulations, since they have not been sold in
Canada for sufficient time and in sufficient quantity to establish safety and
efficacy under the conditions of use as recommended.
The sale of the proposed
product for clinical investigation or other purposes is, in the view of the
Branch, not permitted, until information is submitted and found in compliance
with the above-mentioned Regulations.
[24]
This
decision is the subject of the second application under consideration,
T-706-10.
THE EVIDENCE
[25]
In
the later of the two applications, T-706-10, the Applicant filed the affidavit
of Dr. Willem Wassenaar, president of Wellesley, sworn May 7, 2010, together
with several exhibits, including the record filed in the earlier application,
T-1537-07. Wassenaar was not cross-examined. Health Canada filed no
evidence in T-706-10.
[26]
In
the earlier application, T-1537-07, the Applicant filed the affidavit of the
same Dr. Willem Wassenaar, sworn September 18, 2007, with several exhibits; the
affidavit of Dr. Peter Selby Clinical Director of the Addiction Program of the
Centre for Addition Program of the Centre for Addition and Mental Health, sworn
January 28, 2008, with several exhibits; and the reply affidavit of Dr. Stuart
Macleod, Executive Director of the Child & Family Research Institute ,professor
of paediatrics at the University of British Columbia, and sometime consultant
to Health Canada with several exhibits. Parts of the Macleod affidavit had been
redacted by an Order of a Prothonotary. None of these persons was
cross-examined.
[27]
Health
Canada filed, in application T-1537-07, the Affidavit of Dr. Cathy Petersen,
Division Manager, Bureau of Cardiology, Allergy and Neurological Sciences,
Therapeutic Products Directorate (TPD), Health Canada, sworn April
29, 2009, with several exhibits. Dr. Petersen was cross-examined on August 27,
2009 and several exhibits marked during that cross-examination, together with a
transcript of the cross-examination, were filed in the record.
[28]
There
were no live witnesses appearing before the Court. Having reviewed the
evidence, I have no reason to doubt the credibility of any witness. I have
determined that Dr. Petersen was only partially involved in the relevant
activities at TPD. There seems to have been several levels of activity going
on, and she was privy to or involved in only part of those activities. Her
evidence therefor is based in significant measure on her review of the
documents in the file at TPD. I have in mind, for instance, her answers to
questions 7 through 23, and 74 through110, as illustrative of the fact that Dr.
Petersen had only a limited, first-hand knowledge as to what occurred at TPD
with specific reference to Wellesley’s applications. She had
a general knowledge of the customary procedures followed at TPD.
[29]
Counsel
agreed that evidence in one application can be referred to as if it were
evidence in the other.
THE ISSUES
[30]
The
principal issue in each application is whether the decision under review should
be quashed and sent back for re-determination. I will address the particular
issues raised in each case.
Standard
of Review
[31]
Both
Counsel agreed that where the Minister (Health Canada) is entitled
to exercise discretion, the standard of review is that of reasonableness.
Recently, Justice O’Keefe of this Court in Hospira Healthcare Corporation v.
Canada (Attorney General) and The Minister of Health, Feb 25, 2010, 2010 FC
213 (Hospira) considered the question of standard of review in respect
of many of the same Regulations as are applicable here, and concluded at
paragraph 33 that, on questions of fact and exercise of discretion, reasonableness
is the appropriate standard. I agree:
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.
[32]
However,
when determining jurisdiction and some other questions of law, the Court must
apply a correctness standard, without deference to the decision-maker’s
reasoning, and to provide its
own view and the correct answer. The
Supreme Court of Canada instructed in Dunsmuir v. New
Brunswick,
[2008] 1 S.C.R. 190 as follows at paragraph 50:
50 As
important as it is that courts have a proper understanding of reasonableness
review as a deferential standard, it is also without question that the standard
of correctness must be maintained in respect of jurisdictional and some other
questions of law. This promotes just decisions and avoids inconsistent and
unauthorized application of law. When applying the correctness standard, a
reviewing court will not show deference to the decision maker's reasoning
process; it will rather undertake its own analysis of the question. The
analysis will bring the court to decide whether it agrees with the
determination of the decision maker; if not, the court will substitute its own
view and provide the correct answer. From the outset, the court must ask
whether the tribunal's decision was correct.
[33]
Thus,
it is not open to a Court simply to decide if a determination by the Minister
or Health Canada is
reasonable, it must be correct when considering jurisdiction or some other
question of law. I agree that where some question of interpretation falling
within a Board’s expertise is to be made, that interpretation is to be given
some deference, but the Court cannot simply leave the interpretation of a Regulation,
for instance, to the Minister alone. If the latter statement is what O’Keefe J.
meant at paragraph 43 of his Reasons in Hospira, which I don’t think he
did mean, then I disagree with it.
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.
[34]
I
understand that Hospira is presently under appeal.
The
DIN Decision
[35]
This
question pertains to application T-706-10. The decision at issue is set out in
Health Canada’s letter of
March 29, 2010. The operative part of that letter states:
We regret to inform you that a
Drug Identification Number (DIN) for Abstayne (Control#118378) will not be
issued at this time since the product is considered to be a New Drug as defined
in Division 8 of the Canadian Food and Drugs Regulations.
. . .
Products containing disulfiram
are considered to be new Drugs, as defined in Division 8 of the Canadian Food
and Drugs Act and Regulations, since they have not been sold in Canada for
sufficient time and in sufficient quantity to establish safety and efficacy
under the conditions of use as recommended.
[36]
In
brief Health Canada did not
consider that the disulfiram drug had not been sold in Canada:
“…for sufficient time and in sufficient
quantity to establish safety and efficacy…”
[37]
To
this extent, the decision repeats the language of section C.08.001 (a) of the Regulations
set out earlier, which I repeat:
C.08.001. For the purposes of the Act
and this Division, “new drug” means
(a) a drug that contains or consists of
a substance, whether as an active or inactive ingredient, carrier, coating,
excipient, menstruum or other component, that has not been sold as a drug in
Canada for sufficient time and in sufficient quantity to establish in Canada
the safety and effectiveness of that substance for use as a drug;
[38]
This
DIN application was filed by Wellesley in November 2007. Its
position was set out in a cover letter from its representative, Scientific
Affairs Consultants Inc., dated November 26, 2007. The position was that
disulfiram had been on the Canadian market for fifty years, and is still
available elsewhere; it has been available for “sufficient” time and in
“sufficient” quantity to prove its safety and effectiveness. Scientific
literature references to support this position were provided. That letter
states, in part:
Disulfiram was first used in 1949. In
Canada, disulfiram entered the market in 1966 under the trademark Antabuse® by
Wyeth Canada. Various mergers lead to
pharmaceutical plant closings and the decision to discontinue the marketing of
Antabuse® (250 mg and 500 mg) by Wyeth Canada on May 7th, 2001. Currently,
there is no approved disulfiram in Canada but it has been available through
compounding pharmacies. Disulfiram is approved and available in the United
States and Europe from manufacturers other than
Wyeth.
This DIN submission represents a re-entry
of disulfiram to the Canadian market. Wellesley believes a DIN submission
should be sufficient for health Canada to evaluate and potentially approve this
old drug. A new drug submission should not be necessary to assess disulfiram
considering its long history of safe and effective use. According to the
regulations a new drug is defined as a ‘drug which has not been sold for that
use or condition of use in Canada for sufficient time and in sufficient
quantity to establish in Canada the safety and effectiveness of that substance
for use as a drug’. This is certainly not the case for disulfiram. In fact,
disulfiram is still approved and available in major jurisdictions such as the United States and Europe which further
attests to its usefulness and ultimately its favourable risk/benefit profile.
A brief review of recent clinical studies
conducted with disulfiram has been summarized in volume 1, page 61 of this
submission. While it is acknowledged that this review may be selective to
modern better controlled studies we also acknowledge that it does not work for
every alcoholic. However, disulfiram, like many other drugs, remains effective
for selected patients. Even Health Canada, in its report of 1999, Best Practices
Substance Abuse Treatment and Rehabilitation, has endorsed the use of
disulfiram for selected populations. Therefore, efficacy from either a clinical
or biopharmaceutical viewpoint should not be a deterrent for the review this
DIN application.
Safety information should also not deter
the review of this application. Considering the length of time that disulfiram
has been on the Canadian (as well as other markets) the safety profile is well
established and known. We have reviewed Health Canada’s safety database on disulfiram, which
is available online. There is nothing in that database to suggest or indicate
that the drug has an unfavourable safety profile.
. . .
A rough estimate of ADRs from disulfiram
was between 1 per 200 to 2000 per treatment year, which corresponds to an
intermediate rate of adverse reactions along with many other drugs (Enghusen
Poulsen et al 1992]. Therefore, the safety profile of disulfiram is well known,
similar to other drugs, and should not deter Health Canada from accepting this DIN submission.
In summary, Wellesley believes that
Abstayne® is not a new drug because disulfiram has a long safety and efficacy
history. This history has a favourable risk/benefit ratio. The active
ingredient in Abstayne®, disulfiram (USP, Ph. Eur), is pharmaceutically
equivalent to disulfiram (USP, Ph. Eur) by definition. Abstayne® also contains
98% disulfiram. Disulfiram does not exhibit complex kinetics. Therefore, there
is no scientific justification for Health Canada not to accept this application as a DIN
submission.
[39]
Health
Canada, as
previously described, provided a lengthy document entitled “Status of
Disulfiram – Issue Analysis” with its letter of March 29, 2010. That Issue
Analysis begins:
Status of Disulfiram – Issue Analysis
Overview
The object of this analysis is to assess
the status of disulfiram for drug submission review purposes under the Food and
Drug Regulations. In particular, this review will consider whether disulfiram
meets the definition of “new drug” set out in C.08.001 of the Regulations. If
disulfiram meets the “new drug” definition, approval for marketing in Canada requires the filing of a “new
drug submission” pursuant to the provisions of Part C, Division 8 of the
Regulations. If disulfiram does not meet the definition, approval may be
obtained by filing of a “DIN submission” pursuant to the provisions of Part C,
Division 1.
For the purpose of this analysis, the
relevant portion of C.08.001 defines new drug as:
(a) a drug that contains or consists of a
substance, whether as an active or inactive ingredient, carrier, coating,
excipient, menstruum or other component, that has not been sold as a drug in
Canada for sufficient time and in sufficient quantity to establish in Canada
the safety and effectiveness of that substance for use as a drug.
In light of the above, the focus of this
analysis will be on the post-market history of disulfiram and whether that
history establishes the safe and effective use of the drug. To that end, this
analysis will consider the arguments and evidence provided by Wellesley
Therapeutics in support of the view that disulfiram is not a “new drug” as well
as other evidence available to Health Canada not referenced by Wellesley
Therapeutics in its submission material.
Product Information
Disulfiram was introduced to the Canadian
market by Wyeth Pharmaceuticals Inc. in 1949 under the brand name Antabuse. On
May 27th, 2001, Wyeth voluntarily discontinued marketing Antabuse in
Canada.
Wellesley Therapeutics now seeks approval for a
disulfiram product under the name Abstayne. Wellesley asserts that its product is not a “new
drug” and is properly regulated under Division 1 of the Regulations.
Of note, a review of internal material
reveals that health Canada notified ICN Canada Ltd. on
may 15, 1984 that disulfiram was considered to be a “new drug” subject to
regulation under Division 8 (Appendix 1). Although the letter does not outline
the scientific basis for the position that disulfiram is a new drug, it does
indicate that Health Canada considered disulfiram to be a new drug 16 years
prior to its withdrawal from the Canadian market.
It should also be noted that, despite
this assertion from Health Canada, disulfiram is not currently listed on the New Drug List.
However, as products are generally only added to the New Drug List after the
issuance of a Notice of Compliance (NOC), in the absence of an approved new
drug submission, a product would not typically have the opportunity to be added
to this list.
In its application, Wellesley argues that the long
marketing history of disulfiram has established the safety and effectiveness of
the drug. In support of this position, Wellesley has provided 41 literature references
speaking to safety and efficacy issues. They have also included a Non-clinical
and Clinical Overview with their submission that summarizes the references
provided. The list of references is included as Appendix 2.
l. Overview of clinical information
provided in support of Safety and Efficacy of ABSTAYNE
Review of Clinical Overview for ABSTAYNE
Efficacy overview
(Here there follows an analyses of
several literature references cited by Wellesley. It is noted that Wellesley provided no clinical trial
data.)
Safety overview
(Again, several literature references
were reviewed.)
Canada Post-market safety date
(A review of “adverse events” was made,
some 56 such events were considered.)
Literature search for safety date
(Health Canada undertook its own literature search and
reviewed that literature.)
Reviewer’s Conclusion of Safety Overview
Based on the arguments above, the company
has failed to establish clear data on the incidence and type of adverse
reactions that could occur in patients taking disulfiram treatment, and has
also failed to establish a “safety margin” for patients who take concomitant
alcohol. In addition, no risk mitigation measures have been proposed that may help
reduce the risk of adverse reactions associated with the drug. The clinical
overview that was provided lacks sufficient detail, only provides information
on published studies and case reports, and fails even to provide all of the
available published information that could contribute to the establishment of a
safety profile on the drug. Therefore, they have clearly failed to establish
the safety profile of the drug.
Review of supporting references
(A review of further references was
given.)
Comparator Products for the same
indication
(Two other products REVIVA (naltrexone)
and CAMPRAL (acamprosate) were considered. In the course of that consideration,
the following statement was made):
…the regulator must not only consider the
benefit/risk profile of the drug that is under review, but also the relative
benefit/risk profile of that product compared to other products for the same
indication. Historically, there are numerous cases of products with a long
marketing history that have been removed from the Canadian market due to the
discovery or characterization of serious adverse events, or because of the
advent of newer, safer alternatives to treat the same illness.
. . .
The following conclusion was made:
Overall Risk/Benefit conclusion from data
provided
After review of the materials submitted
by Wellesley, and examination of
additional information referenced above it is evident that the post-marketing
experience with disulfiram is such that its safe and effective use has not been
established. The company’s assertion that the drug is not a new drug, does not take
into account all the available evidence. While there is some evidence of
limited efficacy of disulfiram as an adjunct to behavioural therapy, this has
not been well-established. In addition, Wellesley has failed to provide sufficient detail
on the safety of disulfiram. They have not provided a rationale for exclusion
of a large body of literature evidence of safety issues with the product, and
have failed to properly analyze the case report data available in Canada.
In the face of limited evidence of efficacy,
even limited toxicity can assume importance in establishing a benefit/risk
profile. Serious safety issues identified with disulfiram include
hepatotoxicity, cardiovascular side effects, serious skin reactions,
neuropsychiatric reactions, and sudden death. Several of these adverse
reactions are idiosyncratic in nature (unpredictable) and therefore are very
difficult to mitigate through pharmacovigilance systems, or even through close
medical supervision.
Wellesley has also failed to account for the other
available therapies that have come to market that appear to have improved
benefit/risk profiles relative to disulfiram. Although the benefit/risk profile
of disulfiram may not have changed relative to the disulfiram product that was
previously marketed its relative benefit/risk compared to other pharmacologic
interventions for management of alcoholism has. Given the borderline efficacy
noted in the poorly designed trials, and anecdotal and trial evidence of
serious safety issues, the benefit/risk profile for this product does not
appear favourable based on the evidence reviewed.
[40]
In
argument, Wellesley’s Counsel
made the following points in urging that the decision should be set aside:
a. Health Canada failed to
give proper consideration to the fact that a fifty-year track record in Canada with
millions of doses should in and of itself constitute “sufficient” time and
quantity to make safety and efficacy self-evident.
b. Health Canada made a
selective and incorrect analysis of the literature references.
c. Health Canada was fixated
upon a requirement for clinical test data when none is required in a DIN
application.
d. Health Canada made
improper references to other available products.
e. Health Canada failed to
consider the affidavit evidence submitted as part of the record in T-1537-07.
[41]
I
will consider each of these points in turn.
(1) Health
Canada failed to give proper consideration to the fact that a fifty-year track
record in Canada with millions of doses
should in and of itself constitute “sufficient” time and quantity to make
safety and efficacy self-evident.
[42]
On
the face of it, Wellesley makes an attractive argument in saying that surely
fifty years of use and millions of doses is sufficient to make safety and
efficacy self-evident, particularly since at no time did Health Canada require
the previous seller of the product to withdraw the product or justify its
continuing sale in Canada or make any adjustments to the product or its
labelling.
[43]
Counsel
for Health Canada makes a very
candid argument in saying that listing criteria and analytical and testing
techniques of fifty years ago are not those of today. It is difficult to
monitor every drug that has been approved. An appropriate time to revisit
whether a drug should be approved is when one party has discontinued its sale
and another party seeks approval to sell.
[44]
Further,
Health Canada’s Counsel
argues, the Issue Analysis provided by Health Canada is responsive to the
submissions made by Wellesley’s representative. The points raised, including
the sufficiency of time and doses and the literature presented, have been
reviewed. In addition, Health Canada sought out and reviewed other literature.
[45]
I
am satisfied that the use of the word “sufficient” in section C.08.001 of the
Regulations does not mean that the simple passage of a long period of time or
administration of a great many doses in and of itself dictate that the Minister
must be satisfied as to safety and efficacy. The word “sufficient” implies a
standard that may be variable, depending upon the circumstances. The Concise
Oxford Dictionary defines the word in saying “sufficing, adequate
esp. in amount or number to the need, enough”. It is appropriate for Health
Canada, as the need
arises including, as in the present circumstances, when it becomes expedient to
do so, to make an assessment as to whether the time and quantity is
“sufficient” in and of itself to determine safety and efficacy. In this case,
Health Canada determined
that such sufficiency did not exist. I find no reviewable error in that
determination. Health Canada’s decision was reasonable.
(2) Health
Canada made a
selective and incorrect analysis of the literature references.
[46]
Wellesley’s
Counsel in argument took the Court through some, but not all, of the analyses
of the scientific literature as set out in Health Canada’s “Issue Analysis” in
an effort to point out that parts of such literature may have been overlooked,
or misinterpreted, or dealt with selectively so as to stress only matters
unfavourable to disulfiram. There is no affidavit or other evidence in the
record to support Counsel’s critique. I have myself reviewed the literature
references and while I agree to some extent with Counsel’s submissions, I
cannot, as a judge and not as a person skilled in the area, come to a conclusion
that the analyses made and conclusions reached by Health Canada are
unreasonable, let alone so unreasonable that the decision must be set aside.
(3) Health
Canada was fixated
upon a requirement for clinical test data when none is required in a DIN
application.
[47]
The
“Issue Analysis” did comment upon the fact that no clinical test data had been
presented. It is true that a DIN submission does not require such data.
However, the decision under review determined that the application could not be
treated as a DIN application because there was insufficient information,
whether by passage of time, number of doses, or by the literature references
for Health Canada to determine
safety and efficacy. Health Canada made no reviewable error in stating that
more information would be needed and that clinical test data would be
desirable.
(4) Health
Canada made
improper references to other available products.
[48]
The
“Issue Analysis” made reference to two other drugs used in the treatment of
alcoholism. Health Canada in that Analysis stated that it must not only
consider the benefit/risk profile of the drug in question, but the relative
benefit/risk profile of that product compound to other products for the same
indication. I can find no basis in the Act or the Regulations for
such a requirement. It may be desirable, it may be useful, but nowhere is it a
requirement.
[49]
Dr.
Petersen said that DIN applications were usually considered where the product
in question was something like a fluoride toothpaste or sunscreen lotion. The
Court can take judicial notice that there are hundreds of competitive products
of this nature offered for sale in Canada. There is no evidence
that Health Canada, before approving another such product on a DIN application,
makes a comparison with the many others already approved for sale. Even if it
were to do so, neither the Act nor the Regulations establish any
criteria by which the risk/benefit of the candidate product is to be measured
as against the others, or the threshold to be met before approval is given.
[50]
Here,
Health Canada did state
that two other products were already approved and available for use in treating
alcoholism in Canada. However, I
find that this was not a determinative factor by which Health Canada made its
decision. It was not an error to mention the point. I find that it did not play
a vital role in the reaching of the decision. There is no basis on this ground
to set aside the decision.
(5) Health
Canada failed to
consider the affidavit evidence submitted as part of the record in T-1537-07.
[51]
Nowhere
in the decision letter or in the Issues Analysis does Health Canada refer to
the record filed in application T-1537-07, which record was submitted to Health
Canada by Wellesley as part of
the materials in support of its DIN application. In particular, Health Canada does not
refer to any of the affidavits of Drs. Wassenaar, Selby, or Macleod, or the
statements made in their affidavits.
[52]
Those
affidavits, to the extent that they would be relevant at all to the DIN
application is opinion, not factual. No new scientific information or data is
provided. The application is not a hearing. Health Canada does not
receive and consider opinion evidence as a Court would, nor is it required to
assess, weigh or balance such evidence. As a matter of good practice, it should
have clearly acknowledged that it received such evidence; however, the apparent
failure to consider such evidence does not constitute a reasonable error.
[53]
In
summary, I find that Health Canada made no errors in reaching its decision not
to treat the application as a DIN application that are of such significance as
would require the decision to be set aside and re-determined.
The NDS
Decision
[54]
This
question pertains to application T-1537-07. The decision at issue is set out in
Health Canada’s letter
dated July 23, 2007 with the accompanying Issue Analysis Summary.
[55]
In
this case, Wellesley had filed
the application as an NDS application, thus there was no initial conversion
from a DIN to an NDS application. Wellesley filed submissions essentially the
same as in the DIN application, relying on scientific literature and the fact
that the drug had been sold in large quantise in Canada for over
fifty years, and was still available elsewhere. Health Canada insisted
upon more; it wanted clinical test data.
[56]
In
this instance, we do not have the initial submissions made by Wellesley in filing
the NDS application. The record does contain the rejection letter dated October
20, 2006 provided by Health Canada following the initial screening process,
entitled Screening Deficiency Notice. It says, in part:
9) Please provide the results of
well designed and conducted clinical trials supporting the use of your drug
in the context of currently available therapies.
[57]
The
cross-examination of Dr. Petersen, particularly her answers to questions 7 to
16, reveal that at this stage, the person doing the initial screening would not
have looked at the scientific literature provided. That person would simply
have observed that no clinical trial data had been provided and not looked at
anything else.
[58]
Wellesley responded to
the Screening Deficiency Notice, but did not provide any clinical trial data.
Health Canada sent a
Screening Rejection Letter to Wellesley on December 27, 2006
reiterating its request for clinical trial data:
In consultation with the Central Nervous
System Division (CNS) of the Bureau of Cardiology, Allergy, and Neurological
Sciences, it has been determined that in order to assess the risk/benefit of
your drug, the results of well designed and conducted clinical trials are
required. Literature references are not acceptable.
[59]
The
cross-examination of Dr. Petersen previously referred to makes it clear that
Health Canada still had not made any review of the literature submitted.
[60]
Wellesley then asked
for a re-consideration. The cross-examination of Dr. Petersen makes it clear
that even at this stage, the submissions, including the literature provided,
had not been reviewed. In fact, it had never been reviewed until she prepared
her affidavit submitted in these
proceedings. I repeat the question put and
answers given at questions 18 through 23 of her cross-examination:
18 Q. Where did it go from
there? After that point, Wellesley asked for reconsideration. Correct?
A. Yes. I have seen
the papers. I was not there.
19 Q. Were you involved at
all in the reconsideration process?
A. No, I was not. I
was on leave at some time. I believe my director at that time represented me. I
was not at the reconsideration at all.
20 Q. During that process,
there still would be no review of the actual application because of the same
issue that thee were no clinical trials. Is that correct?
A. No. The name of
the drug was known, Abstayne. Disulfiram is well known. I would have known the
name of the drug. I have seen it in the literature.
21 Q. So you were familiar
with the drug, but was there any actual review done beyond this rejection at
the initial screening stage?
A. No.
22 Q. Not as part of the
reconsideration process.
A. No, because we
don’t review publications. We don’t review them.
23 Q. Again, you said that
was relying on the provisions in the Food and Drugs Act Regulations.
A. That’s right.
[61]
There
is no express provision in the Act or Regulations requiring that
clinical trials be conducted and resulting data be provided to Health Canada.
Counsel for Health Canada informed the Court that Health Canada relies on
its interpretation of sections C.08.002 (2)(g) and (h) of the Regulations,
which I will repeat, to state that an NDS application must include clinical
test data:
(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.
[62]
Clinical
testing is a rigorous and often expensive and time-consuming process. The
affidavit of Dr. Macleod, particularly at paragraphs 27 to 29, points out the
frailties of many clinical trials, particularly when compared to a long history
of actual use by the public. Dr. Petersen’s cross-examination, particularly in
answer to questions 191 to 196, for the first time makes it clear what the
nature of the tests were and the data that Health Canada hoped to review. This
was never clearly expressed by Health Canada in the course of its
dealing with the Wellesley NDS application prior to the launch of these legal
proceedings.
[63]
It
is clear from the cross-examination of Dr. Petersen in response to questions 20
to 23 previously set out, that even at the reconsideration stage, no substantive
examination of the
Wellesley submission, including
the literature, had been considered. The letter provided to Wellesley following
reconsideration, dated July 23, 2007, stated in part:
Upon reconsideration, the Directorate
stands by the original decision that the Abstayne submission, which is based on
information from the literature, does not constitute sufficient evidence of
safety and effectiveness for disulfiram. There are two products currently on
the market in Canada for the treatment of alcohol
abuse since disulfiram was first introduced and it is the regulator’s
responsibility to assess the risk/benefit of disulfiram in the current Canadian
context. The Bureau of Cardiology, Allergy and Neurological Sciences is willing
to discuss the requirements of a new NDS.
[64]
The
accompanying Issue Analysis Summary addressed the issue as to the requirement
for clinical test data only briefly, as well as the issue as to other products
on the market. It said:
Issue 1
Sponsor: Since disulfiram has been on the
market in Canada for over 50 years and has
been used effectively for that period, to define disulfiram as a new drug is
contrary to the definition of a “new drug”.
The Food and Drug Act defines a drug as
including “any substance” and C.08.001 states:
“For the purposes of this Act and this
Division “new drug” means:
“(a) a drug that contains or consists of
a substance, whether as an active or inactive ingredient, carrier, coating,
excipient, menstruum or other component, that has not been sold in Canada for a
sufficient time and in sufficient quantity to establish in Canada the safety
and effectiveness of that substance for use as a drug.”
Disulfiram was recently designated as a
“new drug” by Health Canada without rational
justification.
Office of Science: The previously
available disulfiram product, Antabuse, has been discontinued by the innovator.
The issue of new drug status was the subject of an appeal in 2003 and is not
eligible for further discussion within the context of the present reconsideration
request.
Issue 2
Sponsor: The first quoted paragraph
suggests that the submission does not comply with the requirements of the Food
and Drugs Regulations but it does not detail what the requirements are and the
shortfalls of the submission.
Office of Science: The letter has
indicated that the basis for non-compliance is the submission of literature
references rather than full clinical study reports. Literature references are a
poor substitute for full clinical study reports, as they do not typically
include detailed methodology or the full set of expected data tabulations,
listings, and appendices. Re-analyses of the submitted data are not possible
and data for individual patients are not available.
Issue 3
Sponsor: The second paragraph refers to
a consultation with the CNS Division.
a. What was the nature of
the consultation?
b. What was the input from
CNS?
Office of Science: The regulatory
project manager has stated that “in consultation with the Central Nervous
System Division (CNSD) of the Bureau of Cardiology, Allergy, and Neurological
Sciences, it has been determined that in order to assess the risk/benefit of
your drug, the results of well designed and conducted clinical trials are
required. Literature references are not acceptable.” There is no documentation
to review concerning this consultation.
Issue 4
Sponsor: The decision goes on to state
“…it has been determined that in order to assess the risk/benefit…”
a. What is the nature of the
risk/benefit to be determined?
b. The risk/benefit is well
established in Canada after 50 years of use. No
clinical trial can add anything new to the risk/benefit profile. Why after
50 years of use in Canada are literature
references not acceptable?
Office of Science: The risk-benefit of
many currently or previously marketed drugs may be subject to re-evaluation
when new therapeutic options with improved efficacy or safety become available
or when information emerges to generate new or intensified safety concerns.
Because of improved practices in efficacy assessments and drug safety
monitoring, it is likely that new clinical trials could contribute information
relevant to the risk-benefit assessment.
Issue 5
Sponsor: While disulfiram was introduced
to the Canadian market at a time when the amount of data required for
submission was substantially less than required today, this does not make it a
new drug. Health Canada accepted the safety and efficacy of disulfiram when
Health Canada issued DIN numbers to Wyeth
in the recent past.
Office of Science: Health Canada can reassess the risk-benefit
of marketed or previously marketed drugs whenever relevant new information
arises. With the advent of new therapeutic options for the treatment of alcohol
abuse, health Canada is justified in preferring a
re-assessment of the risk-benefit balance for this drug.
Issue 6
Sponsor: Health Canada has not made it clear to the
sponsor why it has not accepted the submission under the process set out in
Section C.08.0021 i.e. ‘the filing of an abbreviated new drug submission.
Office of Science: Health Canada must accept the submission as
an abbreviated new drug-submission because there is no Canadian reference
product.
Issue 7
Sponsor: The availability or
non-availability of a pharmaceutical product for the treatment of alcohol abuse
has important social policy considerations and cannot be arbitrarily dismissed.
Office of Science: TPD recognises that
alcohol abuse is a major public health problem in Canada. Two products are currently
approved in Canada for this indication; naltrexone and
acamprosate.
[65]
The
reference in the response to Issue 1 to an appeal in 2003 is a reference to the
original DIN (powder) application by Wellesley. The only discussion of
the matter by Health Canada that
Counsel could direct the Court to is a
paragraph in Health Canada’s Rejection Letter – Screening, dated December
30, 2002 which says:
Please inform all your
Canadian clients that products containing Disulfiram are considered to be New
Drugs as defined in Division 8 of the Canadian Food and Drugs Regulations since
they have not been sold in Canada for sufficient time and in sufficient
quantity to establish safety and efficacy under the conditions of use
recommended.
[66]
It
is clear from these documents and the evidence of Dr. Petersen that:
a. When Health Canada received Wellesley’s NDS
application, some person doing the initial screening observed that it contained
no clinical test data. No further analyses of the application or accompanying
literature were made even at the later reconsideration stage.
b. Health Canada has a
general practice of rejecting NDS applications that do not contain clinical
test data.
c. Health Canada
at no time during the process told Wellesley what sort of clinical
test data it specifically required.
d. Health Canada put forward
as one of the two reasons for rejecting Wellesley’s
application the evidence of two other drugs directed to the treatment of
alcoholism. At no time did Health Canada direct its mind to the different
manner in which disulfiram was used compared to the manner in which these two
drugs were used in such treatment, or to the desirability of having several
options available to the professional administering such treatment.
[67]
At
this point, I must consider specifically the decision of O’Keefe J. of this
Court in Hospira, recognizing that this decision is under appeal. In
reaching a determination as to what he described as Issue 2: Does section
C.08.002 of the Regulation mandate the submission of clinical
trial data as part of a
New Drub Submission? O’Keefe J. wrote the following at paragraphs
38, 43 and 46:
[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.
. . .
[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.
. . .
[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.
[68]
With
all due respect, I disagree with O’Keefe J. if he has determined that, as a
matter of statutory (regulatory) interpretation, section C.09.002 requires
clinical test data. I would agree with him that Health Canada would be acting
reasonably and within the scope of that Regulation if it asked for
clinical test data in order to satisfy itself as to the safety and efficacy of
a candidate drug. I disagree if that section means that all NDS applications,
regardless of circumstances, must be accompanied by clinical test data.
It is a difference between can and must.
[69]
The
distinction that I have made is important here because in the present case, no
analysis was ever made by Health Canada as to Wellesley’s
submission, no regard was given to the arguments raised, no review of the
literature was conducted. Health Canada simply shut its mind to
the application, even on reconsideration, as soon as it was determined that no
clinical test data was submitted.
[70]
Further,
in the present case, Health Canada never took the trouble to advise Wellesley as to the
kind of clinical test data it was interested in receiving. This is unlike Hospira
and the Apotex case discussed by O’Keefe J. at paragraphs 52 and 54 of his
Reasons:
[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.
. . .
[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.
[71]
The
second aspect to Health Canada’s decision is the reference to competitive drugs
already approved for sale in Canada. As discussed with respect to the DIN
application, there is nothing in the Act or Regulations requiring
any consideration as to alternatives, nor is there any criteria by which they
are to be measured. There is no evidence that the Minister looked very deeply
into these alternatives. No consideration was given to a comparison of the
mechanisms by which they work. No consideration was given to the desirability
of having alternatives available to the caregiver.
[72]
I
find, given the mechanical rejection of the application at the initial stage
and forever thereafter simply because of the lack of clinical test data and the
reliance on the availability of two other approved drugs with no consideration
as to the mechanisms by which they worked, or the desirability of the
alternatives, that Health Canada’s decision to reject Wellesley’s NDS
application was unreasonable. It must be set aside and returned for review on
its merits by consideration of the application including the submissions made
and the literature provided and with full regard as to how the alternative
drugs work, and to the desirability of having a number of alternatives
available. Such review should be conducted and supervised by persons not
involved in the decision under review.
CONCLUSION AND COSTS
[73]
As
a result, I will dismiss application T-706-10, and allow application T-1537-07 and
send the matter back for reconsideration as set out in the previous paragraph.
[74]
I
have received submissions as to costs from Counsel for each party. Counsel for
the Applicant’s submissions go beyond submissions just as to the costs, and
attempt to re-argue part of the case. I have not taken such re-argument into
account in arriving at my decision as to the substantive matters. Applicant’s
Counsel essentially argues that the Applicant, if successful, is entitled to
substantial costs and disbursements, but should not have to pay any costs if
unsuccessful. I do not agree with such an argument. Success or loss in an
application is often a close matter. Here, Counsel for all parties were fair
and helpful. The case for all parties was well prepared and argued. Costs are usually
intended as a partial defrayal of expenses and fees. They are not to assuage
any moral outrage one party or the other may harbour whether justified or not.
[75]
I
agree with the Respondent’s Counsel that costs in the sum of $3,500.00, payable
to the successful party in each case, is appropriate.
“Roger T. Hughes”
Judge
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