Date: 20160712
Dockets: T-1835-13
T-806-14
Citation:
2016 FC 796
Ottawa, Ontario, July 12, 2016
PRESENT: The
Honourable Madam Justice McVeigh
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BETWEEN:
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W. JOHN MARTIN
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Applicant
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And
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MINISTER OF
HEALTH, CANADA
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Respondent
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JUDGMENT AND REASONS
I.
Overview
[1]
This is a consolidated application under section
44 of the Access to Information Act, RSC, 1985, c. A-1 [the Access Act].
Dr. W. John Martin [Dr. Martin, or the Applicant] contests the disclosure of
certain documents, as proposed by the Access to Information and Privacy (ATIP) Division
of Health Canada [Health Canada, or the Department] on behalf of the Minister
of Health [the Respondent, or the Minister], on the basis of statutory
exemptions contained in section 17, subsection 19(1) and paragraphs 20(1)(b) and
(c) of the Access Act.
[2]
For the following reasons, the application will
be granted in part. In reaching this conclusion, I have considered the fact
that Dr. Martin is self-represented and the Court should allow considerable
latitude when assessing pleadings made by self-represented litigants, but such
considerations cannot give him any additional rights or special dispensation (Sauve
v Her Majesty the Queen, 2011 FC 1081 at para 14; aff’d 2012 FCA 287 at
para 6).
[3]
The Orders dated March 5, 2014 and January 6,
2015 of Prothonotary Lafrenière concerning the treatment of the sealed,
confidential materials and documents will continue to apply to the confidential
filed materials and documents.
II.
Background
A.
The Clinical Trial
[4]
The events giving rise to the matter before the
Court began in June 2008, when a Canadian resident [the Study Monitor], visited
with Dr. Martin in the United States. The purpose of the visit was to consult
with Dr. Martin about the clinical outcomes of a trial that Dr. Martin was
conducting on children that had a developmental disability which also affected
the Study Monitor’s son. The trial involved the external use of a solution [the
treatment solution].
[5]
Having reviewed the initial results of the
clinical investigation, the Study Monitor was eager to include his son in the trial.
Dr. Martin approached Health Canada and asked if it was permissible to give some
of the treatment solution to the Study Monitor to bring back to Canada. Dr. Martin’s evidence is that he was told by Health Canada that this was allowed,
as “medical devices when imported by an individual for
their own personal use are not regulated under the Food and Drugs Act (RSC,
1985, c. F-27) or the Medical Devices Regulations (SOR/98-282).”
[6]
Pleased with the initial results of the treatment
on his child, the Study Monitor asked Dr. Martin if he could involve other
Canadian parents in the clinical trial. The Study Monitor contacted Health Canada and was left with the impression that should these other parents wish to try the
treatment solution, they too would fall under the same “personal
use” exemption applicable to the Study Monitor. Dr. Martin claims that
he was not involved in the selection, training or communication process with
these parents other than through his contact with the Study Monitor.
[7]
As participation in the clinical trial grew in Canada, the Study Monitor launched a website used to provide information to participating
parents. The site allowed participating parents to blog about their children’s
progress and share testimonials about the trial’s results. While parts of the
website may have been accessible to the public, certain pages were only
accessible by way of a password given to participating parents and Dr. Martin.
[8]
Shortly thereafter, and for reasons that Dr. Martin
states were unknown to at the time, the treatment solution stopped working. A
number of parents participating in the clinical trial became angry and allegations
were made that some children who had been administered the treatment solution
suffered from serious adverse reactions.
B.
Health Canada Investigation
[9]
In November 2008, Health Canada was contacted by two concerned parents of children that were participating in the clinical
trial. The parents expressed their worries about the safety of the treatment solution
used in the clinical trial. According to files compiled by Health Canada during its review of the complaint, advertisements for the trial claimed that the Department
had authorised the study.
[10]
In the course of the ensuing investigation,
Health Canada contacted the Study Monitor, who in turn immediately contacted Dr.
Martin. Both Dr. Martin and the Study Monitor fully cooperated with Health Canada during the investigation and the clinical trial was promptly brought to an end at Health Canada’s request.
C.
Auditor General’s Report
[11]
In 2011, the Auditor General of Canada released
a report [2011 Attorney General’s report] on Health Canada’s progress towards
establishing/upgrading a database of clinical trials being conducted in Canada.
The report included the following statement:
4.39 [I]n 2008, Health Canada became
aware of an unauthorized clinical trial when it was contacted by parents whose
child was enrolled in the trial and who had concerns about the safety of the
drug being tested. The physician running the trial was not based in Canada but was recruiting Canadian participants. According to files compiled by Health Canada during its review of the complaint, advertisements for the trial claimed that the
Department had authorised the trial. It was not until the parents contacted the
Department with their concerns that they learned that it had not, in fact,
authorised the trial. Electronic access to a listing of trials authorized by
the Department would allow Canadians to consult official information, to verify
claims made by other parties, and to make fully informed decisions.
Chapter 4, Regulating Pharmaceutical Drugs –
Health Canada (Report of the Auditor General of Canada - Fall 2011)
D.
Access to Information Request
[12]
On February 27, 2012, a few months after the
Auditor General’s report was published, Health Canada received several access
to information requests relating to clinical trials in Canada. One of the requests, made in French, largely mirrored the 2011 report and asked for:
Tous documents et rapports d’enquête
relatifs à un essai clinique non autorise qui avait cours en 2008 au Canada,
mené par un médecin établi à l’extérieur du Canada, et qui recrutait des
participants canadiens, jusqu’à ce que Santé Canada en soit averti par les
parents d’un enfant-patient qui y participait. Les publicités relatives à cet
essai clinique prétendaient qu’il avait été autorisé par Santé Canada. (Note:
Voir le point 4.39 du rapport du Vérificateur général du Canada sur Santé
Canada, du 22 novembre 2011, faisait état d’environ 4000 centres d’essai
cliniques).
[13]
Below is the English version of the request that
was provided to Dr. Martin:
All document and investigation reports
relating to an unauthorized clinical trial under way in 2008 in Canada being
run by a physician who was not based in Canada but was recruiting Canadian
participants, until it was brought to the attention of Health Canada by the
parents of a child-patient who was participating in the trial. The clinical
trial was advertised as having been authorized by Health Canada.
E.
T-1835-13
[14]
Dr. Martin’s affidavit evidence is that he was
initially contacted by Mr. Michel Parent, then a Senior Consultant with the
ATIP Division at Health Canada, who notified him in September 2012 of the
pending access to information request. Having already proposed certain exemptions,
Mr. Parent sought representations from Dr. Martin on the remaining responsive
records. Dr. Martin objected to the release of a number of records identified
by Health Canada on the basis that they contained personal and confidential
information. Following lengthy discussions with Mr. Parent, it was agreed that no
material would be released without Dr. Martin’s formal review and that personal
and confidential information would not be released. Dr. Martin was left with
the belief that no information was to be publicly disclosed.
[15]
In January 2013, Mr. Parent contacted Dr. Martin
seeking representations about the disclosure of information contained on the
now inactive website once managed by the Study Monitor, and which had been
captured by Health Canada during the investigation into the clinical trial.
Once again, Dr. Martin expressed his belief that the information was
inappropriate for public release. Mr. Parent’s apparent lack of follow-up and
his failure to ask the Study Monitor for representations left Dr. Martin under
the impression that the records at issue were no longer being considered for
release.
[16]
However, in correspondence dated October 16, 2013,
Dr. Martin was contacted by Mr. Thomas Dastous, an Advanced ATIP Consultant
with Health Canada, and presented with a proposed release package comprised of
46 pages of records.
[17]
Dr. Martin contends that the records included in
the package contained information which had originally been redacted by Mr.
Parent, but now showed confidential and personal information pertaining to Dr.
Martin, the Study Monitor, as well as a number of other third-parties.
[18]
Dr. Martin again objected to the proposed
release package on the basis that the records in question were exempt from
disclosure. Nevertheless, he was told by Mr. Dastous that the information at
issue was disclosable as it was otherwise already in the public domain and
could be gleaned from other sources, such as patent applications that Dr.
Martin had previously filed in the United States.
[19]
On November 4, 2013, Dr. Martin brought an application
for leave and for judicial review of that decision. This is the application in
court file number T-1835-13.
[20]
On January 30, 2014, upon the motion of Dr.
Martin, this Court issued an order instructing Health Canada not to release the information in question until the present application was decided.
F.
T-806-14
[21]
While preparing to respond to Dr. Martin’s
affidavit in the T-1835-13 application, Mr. Ivan Rashid, now Acting Director of
the ATIP Division of Health Canada and the individual responsible for carriage
of the file at the time, identified over 100 pages of further records as being
relevant to the February 27, 2012 access to information request. The responsive
records were presented to Dr. Martin for consultation on February 12, 2014, and
he replied with detailed objections on February 25, 2014.
[22]
On March 17, 2014, Mr. Rashid decided that
Health Canada would release the documents in question, and responded to Dr.
Martin’s objections by noting that he had “mostly
provided representations or objections that are general in nature.” Mr.
Rashid also expressed his view that “most of the
information objected to is not considered confidential third party information
nor would the disclosure be prejudicial sufficient to meet the requirements of
s. 20 of the [Access Act].”
[23]
On March 31, 2014, Dr. Martin filed an
application for leave and for judicial review of that decision with this Court.
This is the application in court file number T-806-14.
III.
Preliminary
[24]
As a preliminary matter, I must note that as
part of the relief set out by Dr. Martin, he not only sought that the records
at issue be disclosed as per his redactions, but also requested that the 2011 Auditor
General’s report, as well as any other relevant documents, be amended to remove
the phrase “unauthorized” when used in reference
to the clinical trial that was being run in Canada. Dr. Martin was adamant that
this was a remedy that he was unwilling to concede.
[25]
Insofar as this request pertains to the making
of an amendment to the 2011 Auditor General’s report, I have determined that
such a remedy is outside the scope of this judicial review and that such relief
will not be granted. My role in considering this application is to review the
records which have been flagged and determine whether the decision to disclose
those documents was properly made in accordance with the relevant
considerations.
IV.
Issue
[26]
The issue before me is whether the records identified
by Health Canada in response to the February 27, 2012 access to information
request, or parts thereof, are exempt from disclosure, pursuant to section 17,
subsection 19(1) and paragraphs 20(1)(b) and (c) of the Access Act.
V.
Relevant Legislation
[27]
The following provisions of the Access Act
are relevant for the purposes of this application for judicial review:
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Safety of individuals
17 The
head of a government institution may refuse to disclose any record requested
under this Act that contains information the disclosure of which could
reasonably be expected to threaten the safety of individuals.
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Sécurité des individus
17
Le responsable d’une institution fédérale peut refuser la communication de
documents contenant des renseignements dont la divulgation risquerait
vraisemblablement de nuire à la sécurité des individus
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Personal Information
19 (1) Subject to subsection (2), the head of a government institution
shall refuse to disclose any record requested under this Act that contains
personal information as defined in section 3 of the Privacy Act.
Where disclosure authorized
(2)
The head of a government institution may disclose any record requested under
this Act that contains personal information if
(a)
the individual to whom it relates consents to the disclosure;
(b)
the information is publicly available; or
(c)
the disclosure is in accordance with section 8 of the Privacy Act.
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Renseignements personnels
19 (1) Sous réserve du paragraphe (2), le responsable d’une institution
fédérale est tenu de refuser la communication de documents contenant les
renseignements personnels visés à l’article 3 de la Loi sur la protection des
renseignements personnels.
Cas où la divulgation est
autorisée
(2) Le responsable d’une institution fédérale peut donner
communication de documents contenant des renseignements personnels dans les
cas où :
a)
l’individu qu’ils concernent y consent;
b)
le public y a accès;
c)
la communication est conforme à l’article 8 de la Loi sur la protection des
renseignements personnels.
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Third party information
20 (1) Subject to this section, the head of a government institution
shall refuse to disclose any record requested under this Act that contains
(a)
trade secrets of a third party;
(b)
financial, commercial, scientific or technical information that is
confidential information supplied to a government institution by a third
party and is treated consistently in a confidential manner by the third
party;
(b.1) information that is supplied in confidence to a government
institution by a third party for the preparation, maintenance, testing or
implementation by the government institution of emergency management plans
within the meaning of section 2 of the Emergency Management Act and that
concerns the vulnerability of the third party’s buildings or other
structures, its networks or systems, including its computer or communications
networks or systems, or the methods used to protect any of those buildings,
structures, networks or systems;
(c)
information the disclosure of which could reasonably be expected to result in
material financial loss or gain to, or could reasonably be expected to
prejudice the competitive position of, a third party; or
(d)
information the disclosure of which could reasonably be expected to interfere
with contractual or other negotiations of a third party.
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Renseignements de tiers
20 (1) Le responsable d’une institution fédérale est tenu, sous réserve
des autres dispositions du présent article, de refuser la communication de
documents contenant :
a)
des secrets industriels de tiers;
b)
des renseignements financiers, commerciaux, scientifiques ou techniques
fournis à une institution fédérale par un tiers, qui sont de nature
confidentielle et qui sont traités comme tels de façon constante par ce
tiers;
b.1) des renseignements qui, d’une part, sont fournis à titre
confidentiel à une institution fédérale par un tiers en vue de l’élaboration,
de la mise à jour, de la mise à l’essai ou de la mise en oeuvre par celle-ci
de plans de gestion des urgences au sens de l’article 2 de la Loi sur la
gestion des urgences et, d’autre part, portent sur la vulnérabilité des
bâtiments ou autres ouvrages de ce tiers, ou de ses réseaux ou systèmes, y
compris ses réseaux ou systèmes informatiques ou de communication, ou sur les
méthodes employées pour leur protection;
c)
des renseignements dont la divulgation risquerait vraisemblablement de causer
des pertes ou profits financiers appréciables à un tiers ou de nuire à sa
compétitivité;
d)
des renseignements dont la divulgation risquerait vraisemblablement
d’entraver des négociations menées par un tiers en vue de contrats ou à
d’autres fins.
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Third party may apply for a
review
44 (1) Any third party to whom the head of a government institution is
required under paragraph 28(1)(b) or subsection 29(1) to give a notice of a
decision to disclose a record or a part thereof under this Act may, within
twenty days after the notice is given, apply to the Court for a review of the
matter.
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Recours en révision du tiers
44 (1) Le tiers que le responsable d’une institution fédérale est tenu,
en vertu de l’alinéa 28(1)b) ou du paragraphe 29(1), d’aviser de la
communication totale ou partielle d’un document peut, dans les vingt jours
suivant la transmission de l’avis, exercer un recours en révision devant la
Cour
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[28]
The relevant provisions of the Privacy Act,
RSC, 1985 c. P-21 [the Privacy Act] are:
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Definitions
3
In this Act,
[…]
personal information means information about an identifiable individual that is
recorded in any form including, without restricting the generality of the
foregoing,
(a)
information relating to the race, national or ethnic origin, colour,
religion, age or marital status of the individual,
(b)
information relating to the education or the medical, criminal or employment
history of the individual or information relating to financial transactions
in which the individual has been involved,
(c)
any identifying number, symbol or other particular assigned to the
individual,
(d)
the address, fingerprints or blood type of the individual,
(e)
the personal opinions or views of the individual except where they are about
another individual or about a proposal for a grant, an award or a prize to be
made to another individual by a government institution or a part of a
government institution specified in the regulations,
(f)
correspondence sent to a government institution by the individual that is
implicitly or explicitly of a private or confidential nature, and replies to
such correspondence that would reveal the contents of the original
correspondence,
(g)
the views or opinions of another individual about the individual,
(h)
the views or opinions of another individual about a proposal for a grant, an
award or a prize to be made to the individual by an institution or a part of
an institution referred to in paragraph (e), but excluding the name of the
other individual where it appears with the views or opinions of the other
individual, and
(i)
the name of the individual where it appears with other personal information
relating to the individual or where the disclosure of the name itself would
reveal information about the individual,
but, for the purposes of sections
7, 8 and 26 and section 19 of the Access to Information Act, does not include
(j)
information about an individual who is or was an officer or employee of a
government institution that relates to the position or functions of the
individual including,
(i) the fact that the individual is or was an officer or employee of
the government institution,
(ii) the title, business address and telephone number of the
individual,
(iii) the classification, salary range and responsibilities of the
position held by the individual,
(iv) the name of the individual on a document prepared by the
individual in the course of employment, and
(v) the personal opinions or views of the individual given in the
course of employment,
(k)
information about an individual who is or was performing services under
contract for a government institution that relates to the services performed,
including the terms of the contract, the name of the individual and the
opinions or views of the individual given in the course of the performance of
those services,
(l)
information relating to any discretionary benefit of a financial nature,
including the granting of a licence or permit, conferred on an individual,
including the name of the individual and the exact nature of the benefit, and
(m)
information about an individual who has been dead for more than twenty years;
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Définitions
3 Les définitions qui suivent
s’appliquent à la présente loi.
[…]
renseignements personnels Les renseignements, quels que soient leur forme et leur support,
concernant un individu identifiable, notamment:
a)
les renseignements relatifs à sa race, à son origine nationale ou ethnique, à
sa couleur, à sa religion, à son âge ou à sa situation de famille;
b)
les renseignements relatifs à son éducation, à son dossier médical, à son
casier judiciaire, à ses antécédents professionnels ou à des opérations
financières auxquelles il a participé;
c)
tout numéro ou symbole, ou toute autre indication identificatrice, qui lui
est propre;
d)
son adresse, ses empreintes digitales ou son groupe sanguin;
e)
ses opinions ou ses idées personnelles, à l’exclusion de celles qui portent
sur un autre individu ou sur une proposition de subvention, de récompense ou
de prix à octroyer à un autre individu par une institution fédérale, ou
subdivision de celle-ci visée par règlement;
f)
toute correspondance de nature, implicitement ou explicitement, privée ou
confidentielle envoyée par lui à une institution fédérale, ainsi que les
réponses de l’institution dans la mesure où elles révèlent le contenu de la
correspondance de l’expéditeur;
g)
les idées ou opinions d’autrui sur lui;
h)
les idées ou opinions d’un autre individu qui portent sur une proposition de
subvention, de récompense ou de prix à lui octroyer par une institution, ou
subdivision de celle-ci, visée à l’alinéa e), à l’exclusion du nom de cet
autre individu si ce nom est mentionné avec les idées ou opinions;
i)
son nom lorsque celui-ci est mentionné avec d’autres renseignements
personnels le concernant ou lorsque la seule divulgation du nom révélerait
des renseignements à son sujet;
toutefois, il demeure entendu que,
pour l’application des articles 7, 8 et 26, et de l’article 19 de la Loi sur
l’accès à l’information, les renseignements personnels ne comprennent pas les
renseignements concernant :
j)
un cadre ou employé, actuel ou ancien, d’une institution fédérale et portant
sur son poste ou ses fonctions, notamment :
(i)
le fait même qu’il est ou a été employé par l’institution,
(ii) son titre et les adresse et numéro de téléphone de son lieu de
travail,
(iii) la classification, l’éventail des salaires et les attributions de
son poste,
(iv) son nom lorsque celui-ci figure sur un document qu’il a établi au
cours de son emploi,
(v) les idées et opinions personnelles qu’il a exprimées au cours de
son emploi;
k)
un individu qui, au titre d’un contrat, assure ou a assuré la prestation de
services à une institution fédérale et portant sur la nature de la
prestation, notamment les conditions du contrat, le nom de l’individu ainsi
que les idées et opinions personnelles qu’il a exprimées
au cours de la prestation;
l)
des avantages financiers facultatifs, notamment la délivrance d’un permis ou
d’une licence accordés à un individu, y compris le nom de celui-ci et la
nature précise de ces avantages;
m)
un individu décédé depuis plus de vingt ans. (personal
information)
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VI.
Standard of Review
[29]
The Access Act provides a general right
of access to information held by government institutions, subject to certain
exemptions. When determining whether the records at issue fall within a
statutory exemption to disclosure, the standard of review is always correctness
(Wyeth-Ayerst Canada Inc v Canada (Attorney General), 2003 FCA 257 at paras 11-15; Canada Post Corp v
Canada (Minister of Public Works and Government Services), 2004 FC 270 at
paras 24, 27; Canada (Information Commissioner) v Royal Canadian Mounted
Police Commissioner, [2003] 1 S.C.R. 66 [RCMP Commissioner] at para 19).
[30]
Where there remains a
residual discretion that falls to the relevant minister or institution head
allowing for disclosure after an initial exemption has been found, the standard
of review is reasonableness (Canada (Information
Commissioner) v Canada (Minister of Natural Resources), 2014 FC 917 [Natural Resources] at para 26).
[31]
When reviewing decisions on the correctness
standard, the decision-maker is not entitled to deference and the Court
performs its own analysis, substituting its decision for that of the
decision-maker where the two are not in agreement (Dunsmuir v New Brunswick,
2008 SCC 9 [Dunsmuir] at para 50).
[32]
The reasonableness standard is one of deference;
however, the Court must be satisfied that the reasons offered are justifiable,
transparent and intelligible, and that the decision falls within a range of
possible, acceptable outcomes that are defensible with respect to the facts and
law (Dunsmuir, above, at para 47).
VII.
Analysis
[33]
In considering the present applications for
judicial review, this Court’s role is to determine whether Health Canada has
properly applied the exemptions contained in the Access Act to the
records at issue. While there is some debate as to whether this type of
exercise can properly be categorized as a de novo review (Merck Frosst
Canada and Co v Canada (Minister of Health), 2012 SCC 3 [Merck Frosst]
at paras 53, 251), it is beyond reproach that the function of the Court is to undertake a review of the records at issue, progressing
on a detailed document-by-document review where necessary, in order to determine
what is exempt from disclosure and what is not (Air Atonabee Ltd v
Canada (Minister of Transport) (1989), 27 FTR 194 at para 31).
[34]
The party resisting disclosure bears the burden
of proving that the documentation at issue falls within the statutory
exemptions (Merck Frosst, above, at para 92; Brainhunter (Ottawa) Inc
v Canada, 2009 FC 1172 [Brainhunter] at para 13). When reviewing the
decision of the government and assessing whether any of the exemptions are
applicable, the standard of proof is the civil standard of a balance of
probabilities (Merck Frosst at para 94).
[35]
It must be noted that at Tab E, Vol. II of III
of the Respondent’s Record, T-1835-13, and Tab A, Vol. III of V of the Respondent’s
Record, T-806-14, the Minister has included copies of the proposed disclosure
packages in the respective applications. Many of the records at issue already
bear redactions as a result of earlier discussions between Dr. Martin and
Health Canada and nothing in this decision is intended to reverse or in any way
affect those redactions already agreed on. It is my role to decide whether
further redactions are warranted (Janssen-Ortho Inc. v Canada (Minister of Health), 2005 FC 1633 at para 22; aff’d 2007 FCA 252). In doing so, I have
considered section 25 of the Access Act and allowed for the severance and
disclosure of any part of a record that does not contain otherwise exempt
information or material (Merck Frosst at paras 236-239).
A.
Section 17 – Threat to Personal Safety
[36]
Although Dr. Martin only briefly referred to the
section 17 exemption in his affidavit evidence and his memorandum of fact and
law, he did argue that a number of the documents flagged for disclosure by
Health Canada should be exempt on the basis that they contain information
which, if released, could reasonably be expected to threaten his safety, as
well as the safety of the Study Monitor.
[37]
In his affidavit evidence, Dr. Martin identified
one particularly disgruntled parent of a child who had been participating in
the clinical trial. The evidence indicates Dr. Martin’s belief that it was this
parent’s complaint that launched the ensuing investigation by Health Canada in 2008, and that it was this same parent who subsequently made the 2012 access to
information request. Dr. Martin argued that that the release of certain
documents, could “reignite anger and hostility” among
parents of those children with the developmental disability at issue and/or
sympathizers who might wrongly conclude that the Study Monitor or Dr. Martin
had put children at risk through his actions. The fact that Health Canada had proposed
to release his address, full name, email and phone number, he argued, gave rise
to a reasonable expectation of harm.
[38]
In support of his position, Dr. Martin introduced
evidence in the form of two (almost identical) online articles commenting on a
decision of the Ontario Superior Court, wherein which the suspected disgruntled
parent was found guilty of libel in an action brought by the Study Monitor. Dr.
Martin’s evidence is that the parent was found to have published, forged,
created and falsified documents regarding medical conditions in children for
the purposes of discrediting the Study Monitor following his involvement in the
clinical study. Dr. Martin had provided evidence in support of the Study
Monitor in the Ontario Superior Court trial against the parent. Dr. Martin submits
that having testified against an individual who had gone to such lengths
against the Study Monitor is surely proof that his personal safety is in
jeopardy.
[39]
The Minister argues that Dr. Martin’s
submissions do not support his assertion that the disclosure of the un-redacted
information could reasonably be expected to threaten his safety. It is
submitted that Dr. Martin must do more than simply assert harm and must
demonstrate a direct link between disclosure and the alleged harm with detailed
and convincing evidence. Relying on jurisprudence of this Court, the Minister
states that further evidence must be tendered in order to establish that the
harm which Dr. Martin fears is reasonably probable (Merck Frosst at paras
192-206, 219; Saint John Shipbuilding Ltd v Canada (Minister of
Supply and Services), [1990] FCJ No. 81 (FCA) [Saint John Shipbuilding
Ltd] at paras 2-8; Oceans Ltd v Canada-Newfoundland and Labrador
Offshore Petroleum Board, 2009 FC 974 [Oceans Ltd] at para 61; CORADIX
Technology Consulting Ltd v Canada (Minister of Public Works and Government
Services), 2006 FC 1030 [CORADIX] at para 30).
[40]
Although the jurisprudence cited by the Minister
appears to deal exclusively with the reasonable expectation of probable harm in
the context of paragraphs 20(1)(b) and (c) of the Access Act, I see no
reason why to disagree with the Minister’s submissions on this point. In order
to rely on the exemption contained under section 17, the party resisting
disclosure must be able to demonstrate a direct link between disclosure of the
documents and the alleged harm with detailed and convincing evidence in order
to establish that these outcomes are reasonably probable (Merck Frosst
at para 219; CORADIX, above, at para 30).
[41]
Based on the evidence before me, I do not find
that Dr. Martin has met the evidentiary threshold necessary to establish, on a
balance of probabilities, that he faces a reasonable expectation of probable
harm. Neither of the documents submitted by Dr. Martin cites an author or
indicates a date of publication and it must be noted that the written decision
from the Ontario Superior Court was not reproduced (although there was an
unreported citation in the articles). Therefore, I find that these articles
were of little probative value and did not establish that a reasonable
expectation of harm would befall Dr. Martin for having testified at the libel trial
or otherwise participated in the organization of the clinical trial.
[42]
Furthermore, Dr. Martin has not provided a
tangible connection between the identity of the disgruntled parent who he
identified and the identity of the individual(s) who made the initial 2008
complaint to Health Canada or the individual(s) who made the 2012 access to
information request, respectively.
[43]
Even if the individual that made the access to
information request is the same disgruntled that was found guilty of libel
against the Study Monitor, Dr. Martin has submitted no evidence to indicate how
the release of the documents in question would place him at risk of probable
harm, beyond stating that the dissemination of Health Canada records would have
“unforeseen consequences.”
[44]
While I believe Dr. Martin is sincere in stating
he fears for his safety, he has not presented evidence that meets the test to
establish the personal safety exemption contained in section 17 of the Access
Act.
B.
Subsection 19(1) – Personal Information
[45]
A number of the records proposed for release by
Health Canada are opposed by Dr. Martin on the basis that they contain personal
information, contrary to the exemption contained in subsection 19(1) of the Access
Act. The records at issue include printouts of webpages from internet
sites, as well as other information gathered by Health Canada in the course of its investigation into the clinical trial.
[46]
Dr. Martin opposes Health Canada’s contention that the records in question are publicly available. In affidavit evidence, he
submits that much of the material to be disclosed is from a website that was
discontinued in 2009. He argues that access to most of the site was restricted
by password requirements and therefore some of the information was never
publicly available on the internet, as only the parents participating in the
clinical trial, himself and the Study Monitor would have had the password.
[47]
Dr. Martin’s submissions on this issue indicate
that it is his belief that the relevant passwords, or even the documents
themselves, were provided by the Study Monitor or himself to Health Canada in confidence during the investigation. Alternatively, his position is that the passwords
may have been provided to Health Canada by one or more of the concerned parents
who made the original complaints in 2008.
[48]
Dr. Martin further contends that some of the
information included in the proposed disclosure package contains the names of
parents and children participating in the trial, as well as clinical diaries of
the children’s medical progress. He states that it is unfair to include the
names of these individuals and the clinical diaries of the children’s response
to treatment in the proposed release and argues that such an action amounts to “gross-insensitivity” on the part of Health Canada.
[49]
Finally, Dr. Martin argues that, given the vagueness
of the initial access to information request, and considering the extensive
research that Health Canada did to corroborate online records using
confidential and personal information provided by Dr. Martin and the Study
Monitor during the course of the investigation, the personal information should
not be seen as publicly available insofar as the information is not readily
ascertainable without using the information that the two men provided.
[50]
It is worth noting that the most recent redactions
proposed by Health Canada would now exempt Dr. Martin’s email address, street
address, and phone number, as well as his opinions as expressed in
correspondence with Health Canada, and some third-party names. Notwithstanding
the proposed redactions, the Minister acknowledges that many of the records
still include personal information pertaining to both Dr. Martin and the Study
Monitor, and other third-parties.
[51]
The Minister argues that the un-redacted
information was publicly available at the time that it was captured and posits
that much of the information is still publicly available using the website “Archive.org,” an online retrieval service and
web-archive also commonly referred to as the “Wayback
Machine.” Accordingly, the Minister proposes to release these records on
the basis that they are publicly available, pursuant to paragraph 19(2)(b) of
the Access Act. The Minister’s position is that Health Canada obtained
the documents without a password and therefore the documents were publicly available
and should be disclosed.
[52]
Subsection 19(1) of the Access Act
prohibits the disclosure of a record that contains “personal
information,” as defined in section 3 of the Privacy Act. Within
the context of the Privacy Act, Parliament has broadly defined the concept
of personal information as “information about an
identifiable individual that is recorded in any form including […].” In
a much cited passage from the seminal Supreme Court of Canada decision in Dagg
v Canada (Minister of Finance), [1997] 2 S.C.R. 403 [Dagg], La Forest
J., dissenting but confirmed by the majority on this point, commented on the
definition of personal information, at paras 68-69:
68 On a plain reading, this
definition is undeniably expansive. Notably, it expressly states that the list
of specific examples that follows the general definition is not intended to
limit the scope of the former. As this Court has recently held, this
phraseology indicates that the general opening words are intended to be the
primary source of interpretation. The subsequent enumeration merely
identifies examples of the type of subject matter encompassed by the general
definition; see Schwartz v Canada, [1996] 1 S.C.R. 254, at pp. 289-91.
Consequently, if a government record is captured by those opening words, it
does not matter that it does not fall within any of the specific examples.
69 As noted by Jerome A.C.J. in Canada
(Information Commissioner) v Canada (Solicitor General), supra, at p. 557,
the language of this section is "deliberately broad" and
"entirely consistent with the great pains that have been taken to
safeguard individual identity". Its intent seems to be to capture any
information about a specific person, subject only to specific exceptions; see
Alan Leadbeater, Deputy Information Commissioner of Canada, "How Much
Privacy for Public Officials," Speech to Canadian Bar Association
(Ontario), March 25, 1994, at p. 17. Such an interpretation accords with the
plain language of the statute, its legislative history and the privileged,
foundational position of privacy interests in our social and legal culture.
[Emphasis added]
[53]
In light of the relevant jurisprudence that has
emerged on this issue, it is clear that the intent of subsection 19(1), and its
incorporation of section 3 of the Privacy Act, has been interpreted to
protect the privacy or identity of individuals who may be mentioned in
otherwise releasable material.
[54]
Despite the broad definition of personal
information employed by the courts and the great lengths that have been taken
to safeguard individual identity in legislation, subsection 19(2) of the Access
Act provides that the head of a government institution may disclose
personal information in certain circumstances. The specific use of the word “may” in this carve-out has been found to be
indicative of a residual discretion, rather than a statutory duty, that falls
to an administrative decision-maker (Dagg, above, at para 108).
[55]
The Supreme Court has pronounced that this
discretion is to be exercised with respect to the purpose of the exemption at
issue and all other relevant interests and considerations, on the basis of the
facts and circumstances of the particular case. The decision involves two
steps. First, it must be determined whether the personal information exemption
applies. If it does, then consideration must be had with respect to whether,
having regard to all relevant interests, disclosure should be made (Criminal
Lawyers' Assn v Ontario (Ministry of Public Safety and Security), 2010 SCC
23 at para 66).
[56]
In seeking to release the records pursuant to
the exception contained in paragraph 19(2)(b), the onus lies on Health Canada
to establish that the personal information at issue was publicly available (Canada
Jewish Congress v Canada (Minister of Employment and Immigration), [1996] 1
FC 268 at para 34; Yeager v Canada (National Parole Board), 2008 FC 113
at para 44).
[57]
Although the term “publicly
available” is not defined in either the Access Act or the Privacy
Act, in Lukacs v Canada Transportation Agency, 2015 FCA 140, the
Federal Court of Appeal has indicated that the term should be interpreted in a
rather straightforward manner. Writing for the Court, at paragraph 69, Ryer
J.A. noted that:
69 The term Publicly Available appears to
me to be relatively precise and unequivocal. I interpret these words as
meaning available to or accessible by the citizenry at large. This interpretation
is also consistent with the apparent context and purpose of subsection 69(2) of
the Privacy Act. That provision is located in a portion of
the Privacy Act, entitled "Exclusions", that sets out
circumstances in which the Privacy Act, or sections thereof, do not
apply. The purpose of subsection 69(2) of the Privacy Act is
to render the use and disclosure limitations that are contained in sections 7
and 8 of the Privacy Act inapplicable to Personal Information
if and to the extent that the citizenry at large otherwise has the ability to
access such information.
[Emphasis added]
[58]
While Ryer J.A.’s comments came in the
interpretive context of subsection 69(2) of the Privacy Act, there is no
reason to depart from such a definition with respect to the Access Act,
given that the two pieces of legislation form a “a
seamless code with complementary provisions that can and should be interpreted
harmoniously” (RCMP Commissioner, above, at para 22). As a
result, I think this definition would be equally applicable to the definition
of publicly available for the purposes of paragraph 19(2)(b) of the Access
Act.
[59]
This definition is also compatible with the
meaning employed by Snider J. in Canada (Information Commissioner) v
Canadian Transportation Accident Investigation and Safety Board, 2005 FC
384; overturned on other grounds, 2006 FCA 157). In that case, which did deal
specifically with paragraph 19(2)(b) of the Access Act, Snider J. stated
at paragraph 47:
47 It appears to me that, for
information to be in the public domain it must be available on an ongoing basis
for use by the "public". For example, in Timiskaming Indian
Band v Canada (Minister of Indian & Northern Affairs), [1997] FCJ No
676 (Fed TD) at para. 34, this Court stated that documents that had not been
disclosed before were in the public domain because "they have been
available to the public who attend at the Registry and conduct searches and
make specific requests for them under the existing Registry system". In
these cases, there is no public registry or repository where a member of the
public can search for these recordings or find the transcripts of these ATC
communications.
[Emphasis added]
[60]
Therefore, in my view, an administrative
decision-maker seeking to disclose personal information, pursuant to paragraph 19(2)(b),
must be able to demonstrate, as a condition precedent, that the information at
issue was accessible on an ongoing basis by the citizenry at large at the time
the decision was made (Natural Resources, above, at para 58).
[61]
The Minister has not persuaded me that the
condition of ongoing availability of the personal information to the public,
such that it is not restricted to a subset of the population, was met at the
time that the Department made the impugned decisions.
[62]
The affidavit evidence submitted by the Minister
indicates that the records containing personal information were collected by
Health Canada during its investigation into the clinical trial in late 2008 and
early 2009, with much of the same, or substantially similar, information being
accessed by way of internet archival tools in September 2014.
[63]
In my view, this affidavit evidence is of little
probative weight for two reasons. Firstly, no evidence was introduced to
indicate that, at the time the decision to disclose the requested documents was
made in October 2013 and March 2014, Health Canada was satisfied that this
personal information was publicly available. The evidence before me indicates
that Health Canada only discovered that the personal information contained in
the records apparently continued to be available or accessible to the general
public in September 2014; more than six months after the last proposed
disclosure package had been presented to Dr. Martin and the two present
applications had been filed.
[64]
Secondly, in considering the affidavit evidence
filed by both parties, as well as the records themselves, I believe, on the
balance of probabilities, that much of this personal information was provided
by third-parties or otherwise password protected, and thus not otherwise independently
accessible at the time the decision to disclose was made.
[65]
This view is supported by the fact that many of
the records at issue clearly indicate that Dr. Martin, the Study Monitor and
other parents involved in the clinical trial provided Health Canada with personal information that the Department included in the proposed release packages. For
example, pages 53-57 and 69-71 of the proposed release package in T-806-14
reveal that one concerned parent, with access to the website maintained by the
Study Monitor, was sending Health Canada material for the purposes of aiding
its investigation into the clinical trial. These records also included personal
information “posted” to the social networking
website Facebook. The dissemination of this information was seemingly
restricted to those individuals holding membership in a certain group on the
website, as indicated in the concerned parent’s email to Health Canada. Nonetheless, the records containing this personal information were included in the
proposed release package sent to Dr. Martin in March 2014.
[66]
Other records contained in the proposed release
packages were sent directly to Health Canada by Dr. Martin and the Study
Monitor. For example, pages 87-88 and 94-106 of the proposed release package in
T-806-14 show that the Study Monitor sent a number of documents to Health Canada in an effort to assist with the Department’s compliance verification. Similarly,
pages 65-68 of the proposed release package in T-1835-13 show that Dr. Martin
also provided information relating to the clinical trial directly to Health Canada. These records include information pertaining to the protocol of the clinical trial
and make reference to the developmental disability affecting participants in
the trial, the active ingredients in the treatment solution being tested, as
well as medical and non-medical devices being used. These records obviously
contain personal information insofar as they implicate the medical history of
trial participants. The Minister has not provided any evidence that this
information was publicly available at the time the decision to disclose was
made and the fact that these records were not captured by the Wayback Machine
in September 2014 further indicates that these records never were publicly
available.
[67]
Affidavit evidence filed by the Minister
included emails between Mr. Rashid and Ms. Brenda Redmond, an Inspector Manager
with Health Canada, indicate that a password was not required to gain access to
this personal information during the course of the compliance verification of
the clinical trial and that the records gathered by Health Canada inspectors
during the compliance verification were not provided by a third-party.
[68]
In direct contrast, affidavit evidence filed by
Dr. Martin indicates that portions of the website maintained by the Study
Monitor were password-protected and that parents with children participating in
the clinical trial were provided with log-in credentials (Exhibit 2 of Dr.
Martin’s November 10, 2014 affidavit or 146 of Applicant’s Confidential Record).
Other evidence includes an email from the Study Monitor providing Dr. Martin
with log-in credentials (Exhibit 3 of Dr. Martin’s November 10, 2014 affidavit
or 146 of Applicant’s Confidential Record). Furthermore, affidavit evidence
submitted by the Minister found at pages 22, 167 and 177 of Vol. I of II of the
Respondent’s Record, T-1835-13, includes archived material that shows a “Participants Login,” indicating that a user name and
password were required to gain access to the Study Monitor’s website.
[69]
Therefore, through the respective parties’
submissions and affidavit evidence, including the archived webpages captured
through the Wayback Machine, I am satisfied that on the balance of
probabilities, much of the personal information at issue was only accessible to
Dr. Martin, the Study Monitor and parents participating in the clinical trial
through password protected pages on the website.
[70]
To the extent that the information at issue was otherwise
purportedly accessible by way of the Archive.org website, the Minister
presented no evidence as to archiving capabilities of the Wayback Machine,
especially where password protection security on a website is utilized. That
evidence would have been very useful to this Court.
[71]
Notwithstanding this determination, even if the
personal information at issue was publicly available, I find that Health
Canada’s discretionary decision to disclose it was unreasonable.
[72]
As the Minister submits, the overarching purpose
of the Access Act is to facilitate democracy by helping to both ensure
that citizens have the information required to meaningfully participate in the
democratic process and that politicians and bureaucrats remain accountable to
the citizenry (Dagg at para 61).
[73]
However, this is not standalone legislation to
be applied in a vacuum, especially when considering how the records to be
disclosed may implicate the privacy rights of individuals. Rather, the closely
related legislative histories of the Access Act and the Privacy Act
require a reviewing court to consider the purposes of both statutes rather than
viewing each one in isolation from the other (HJ Heinz Co of
Canada Ltd v Canada (Attorney General), 2006 SCC 13 [Heinz] at para
25). As noted above, the Access Act and Privacy Act must be understood
to be a seamless code with complementary provisions and a delicate balance must
be struck between the competing values of the respective statutes.
[74]
The Supreme Court of Canada has addressed the
relationship between the two statutes on a number of occasions. While neither
the right of access to information nor the right to individual privacy ought to
be given absolute pre-eminence, the Supreme Court has previously recognized
that legislation which aims to protect control over personal information should
be characterized as “quasi-constitutional”. This
characterization is because of the fundamental
role privacy plays in the preservation of a free and democratic society; thus,
it is clear from the legislative scheme established by the Access Act
and the Privacy Act that in a situation involving personal information
about an individual, the right to privacy is paramount over the right of access
to information (Lavigne v Canada (Commissioner of Official Languages),
2002 SCC 53 at para 24; Dagg at paras 65-66; Heinz, above, at
paras 28-29). Contrary to most other exemptions contained in the Access Act,
in the context of personal information it cannot be said that any doubt is to
be resolved in favour of disclosure.
[75]
In considering the discretion exercised by Health
Canada with respect to the purpose of the personal information exemption and
the facts and circumstances of this particular case, I do not find that the
decision to disclose is defensible with respect to the facts and the law.
[76]
The access to information request received by
Health Canada was general in nature, broadly asking for “[a]ll document and investigation reports relating to an
unauthorized clinical trial under way in 2008 in Canada being run by a
physician who was not based in Canada but was recruiting Canadian
participants…” (translation). In my view, the scope of the request
focused on the Department’s recognition of, and response to, the clinical trial
initially referenced in the 2011 Auditor General’s report.
[77]
To the extent that the disclosure packages
identify records relevant to the role that Health Canada plays in enforcing
laws and regulations related to drug trials in Canada, such documents are
undoubtedly germane to the request given the overarching purpose of the Access
Act. However, insofar as the disclosures include personal information
relating to Dr. Martin, the Study Monitor, and parents or children
participating in the study, I find that the decision of Health Canada to release these records fails to account for the quasi-constitutional protections
afforded to personal privacy under the Privacy Act. This is especially
so when considering the efforts that had been made to remove much of the
information from the public domain prior to the November 2012 access request
being made, and the fact that the access request made no reference to the
developmental disability at issue, the nature of the study, the physician in
question, or any of the participants.
[78]
In UFCW, Local 401 v Alberta (Information and Privacy Commissioner), 2013 SCC 62 [UFCW, Local 401],
Abella J. and Cromwell J., writing for the unanimous court at paragraph 25,
emphasized the importance of the
protection of privacy in a vibrant democracy, which in turn depends on the
ability of individuals to freely formulate and express unconventional views. In this respect I adopt the obiter of Abella J. and Cromwell
J. in UFCW, above, Local 401, at para 27, and conclude that I am
reluctant to find that in posting something on the internet, an individual automatically forfeits his or her interest in
retaining control over the personal information which is thereby exposed; this
is especially so given the developments in technology, such as the Wayback
Machine, that make it possible for personal information to be recorded with
ease, distributed to an almost infinite audience, and stored indefinitely.
[79]
Furthermore, much of the personal information
was gratuitously provided to Health Canada by the Study Monitor, and, in my
view, the promotion of cooperative efforts in regulatory investigations is best
served in keeping this information confidential. Both Dr. Martin and the Study
Monitor cooperated fully in furnishing everything and doing everything asked of
them by Health Canada, including stopping the trial and putting notices on the
website that Canadians could not participate(page 262, Vol. II of III of the
Respondent’s Record, T-1835-13; pages 43-44, Vol. I of II of the Respondent’s Supplemental
Record, T-1835-13).
[80]
For these reasons, I have concluded that the
following records, or portions thereof, are exempt from disclosure pursuant to
subsection 19(1) in addition to what is already redacted by Health Canada or
will be under subsequent sections in this decision.
(1)
T-1835-13
[81]
Documents in the proposed release package are
found at Tab E, Vol II of Respondent’s Record and identified by release package
page number not the Respondent’s record page number.
|
65
|
•
All geographic references
•
Reference to published study
•
All references to the medical treatments,
protocol and solution used in the clinical trial
|
|
66
|
•
All references to discussions with the
third-party regulator on classification procedures
|
|
107
|
•
All references to the developmental disability
affecting children participating in the clinical trial
|
|
108
|
•
All personal names, except for those of Health
Canada employees
•
All geographic references
•
All references to the developmental disability
affecting children participating in the clinical trial
|
|
109
|
•
All references to the developmental disability
affecting children participating in the clinical trial
|
|
110
|
•
All personal names
•
All references to the developmental disability
affecting children participating in the clinical trial
•
All references to the name of the clinical
trial, in any form including the domain name
•
All references to discussions with the third-party
regulator on classification procedure
|
|
127
|
•
All references to the treatment solution used
in the clinical trial, including in the email subject line
|
|
135
|
•
All geographic references
•
All references to the name of the clinical
trial, in any form
|
|
276-288
|
•
All personal names and email addresses, as
well as references to third-party websites and organizations
•
All geographic references
•
All references to the developmental disability
affecting children participating in the clinical trial, in any form
•
All references to the name of the clinical
trial, in any form including the domain name
•
All references to the name of the treatment
solution and/or any other pharmaceutical drugs used by individuals
participating in the clinical trial
•
All other references to medical conditions,
illnesses or disorders affecting children participating in the clinical
trial.
|
|
289-301
|
•
All ages, personal names and/or usernames
•
All geographic references
•
All references to the developmental disability
affecting children participating in the clinical trial, in any form
•
All references to the name of the clinical
trial, in any form including the domain name
•
All references to the name of the treatment
solution and/or any other pharmaceutical drugs used by individuals
participating in the clinical trial
•
All other references to medical conditions,
illnesses or disorders affecting children participating in the clinical
trial.
•
All references to study protocol and/or
devices used as part of the clinical trial
•
This could be accomplished by redacting the entire
range of records
|
|
384
|
•
All personal names, except for those of Health
Canada employees.
•
All references to the developmental disability
affecting children participating in the clinical trial
•
All references to the name of the clinical
trial, in any form including in the first line of the second paragraph.
•
All references to discussions with the
third-party regulator on classification procedure
•
All references to study protocol and/or
devices used as part of the clinical trial
|
|
385
|
•
Entire page
|
(2)
T-806-14
[82]
Documents in the proposed release package are
found at Tab A, Vol III of V of the Respondent’s Record and identified by
release package page number not the Respondent’s record page number.
|
4
|
•
All personal names, telephone numbers and
email addresses, except for those of Health Canada employees
•
All geographic references
•
All references to the developmental disability
affecting children participating in the clinical trial, including email
subject lines
•
All references to the name of the clinical
trial, in any form including the domain name
•
All references to the treatment solution used
in the clinical trial
•
All references to study protocol and/or
devices used as part of the clinical trial.
|
|
11
|
•
All personal names, except for those of Health
Canada employees
•
All geographic references
•
All references to the developmental disability
affecting children participating in the clinical trial
•
All references to the name of the clinical
trial, in any form including the domain name and email subject line
•
All references to medical conditions or
reactions affecting children participating in the clinical trial
•
All references to the treatment solution used
in the clinical trial
•
All references to study protocol and/or
devices used as part of the clinical trial.
|
|
12
|
•
All geographic references
•
All references to the developmental disability
affecting children participating in the clinical trial, including in the
email subject line
|
|
13
|
•
All personal names , except for those of
Health Canada employees
•
All geographic references
•
All references to the developmental disability
affecting children participating in the clinical trial, including in the
email subject line
•
All references to the name of the clinical
trial, in any form including the domain name
•
All references to the treatment solution used
in the clinical trial
•
All references to study protocol and/or
devices used as part of the clinical trial.
•
Note: this email is included at page 4
|
|
23
|
•
All personal names, except for those of Health
Canada employees
•
All geographic references
•
All references to the developmental disability
affecting children participating in the clinical trial
•
All references to the name of the clinical
trial, in any form including the domain name
•
All references to study protocol and/or
devices used as part of the clinical trial.
|
|
53
|
•
All personal names, except for those of Health
Canada employees
•
All references to the name of the clinical
trial, in any form & domain name
|
|
54
|
•
Entire record
|
|
55
|
•
Entire record
|
|
56
|
•
Entire record
|
|
57
|
•
Entire record
|
|
69
|
•
All personal names, except for those of Health
Canada employees
•
All references to the developmental disability
affecting children participating in the clinical trial
•
All references to the name of the clinical
trial, in any form including the domain name
•
Title and content of the included article
|
|
70
|
•
Entire record
|
|
71
|
•
Entire record
|
|
74
|
•
All references to the developmental disability
affecting children participating in the clinical trial, including in the
email subject lines
•
All geographic references
•
All references to the treatment solution used
in the clinical trial
•
All references to study protocol and/or
devices used as part of the clinical trial.
|
|
75
|
•
All references to the developmental disability
affecting children participating in the clinical trial, including in the
email subject line
•
All references to study protocol and/or
devices used as part of the clinical trial.
|
|
76
|
•
All references to the developmental disability
affecting children participating in the clinical trial, including in the
email subject lines
•
All references to the treatment solution used
in the clinical trial
•
All references to study protocol and/or
devices used as part of the clinical trial.
|
|
77
|
•
All references to the developmental disability
affecting children participating in the clinical trial, including in the email
subject lines
•
All references to the treatment solution used
in the clinical trial
•
All references to study protocol and/or
devices used as part of the clinical trial.
|
|
84
|
•
All references to study protocol and/or
devices used as part of the clinical trial.
|
|
87
|
•
All geographic references
•
Entire content of 28/11/2008 email (last two
paragraphs on page)
•
All references to the treatment solution used
in the clinical trial
|
|
88
|
•
Entire record
|
|
94-106
|
•
Entire range of records
|
|
117
|
•
All geographic references
•
All references to the name of the clinical
trial, in any form
•
All references to the treatment solution used
in the clinical trial
•
All references to study protocol and/or
devices used as part of the clinical trial.
|
|
118
|
•
All geographic references
|
|
119
|
•
All personal names
•
All references to the developmental disability
affecting children participating in the clinical trial, including the file
name
•
All references to the name of the clinical
trial, in any form and/or combination
•
All references to study protocol and/or devices
used as part of the clinical trial, including fees associated with the procedure
|
|
120
|
•
All references to the developmental disability
affecting children participating in the clinical trial, including the file
name
|
|
121
|
•
All references to the developmental disability
affecting children participating in the clinical trial, including the file
name
|
|
122
|
•
Entire record
|
|
229
|
•
All geographic references
•
All references to the name of the clinical
trial, in any form and/or combination
|
|
235
|
•
All references to the developmental disability
affecting children participating in the clinical trial, including the webpage
name
•
All references to the name of the clinical
trial, in any form and/or combination
|
|
236
|
•
Entire record
|
|
237
|
•
All geographic references
•
All references to the name of the clinical
trial, in any form
|
|
238
|
•
All geographic references
•
All references to the name of the clinical
trial, in any form
|
|
239
|
•
Entire record
|
|
243
|
•
Entire record
|
|
255
|
•
Entire record
|
|
256-262
|
•
Entire range of records
|
|
263-265
|
•
Entire range of records
|
|
267
|
•
Entire record
|
|
268
|
•
Entire record
|
|
269-275
|
•
Entire range of records
|
|
340
|
•
All personal names, telephone numbers and
addresses
•
All geographic references
|
|
417
|
•
All references to the name of the clinical
trial, in any form including the file attachment and email subject line
•
All references to study protocol and/or
devices used as part of the clinical trial.
|
|
418-442
|
•
Entire range of records
|
C.
Paragraph 20(1)(b) Confidential Information
[83]
Dr. Martin objects to the disclosure of certain
records, arguing that they meet the exemption set out in paragraph 20(1)(b) on
the basis that they contain specific and detailed technical information
relating to the ingredients of the treatment solution and protocol used in the
clinical trial. Dr. Martin contends that some of the information contained in
the records in question is of a commercial, scientific, and technical nature
and was treated confidentially.
[84]
Specifically, he objects to the disclosure of
the scientific information including the composition of the treatment solution and
the medical treatment protocol; of the treatment. Dr. Martin’s evidence is that
this information was kept confidential for the purposes of treating the particular
developmental disability at issue in the study.
[85]
The Minister’s position is that the technical
information in question is subject to disclosure because the trial was not
conducted in confidence as participants were encouraged to share information
and results with other persons, and the information was made available to the
public on the Study Monitor’s website. Furthermore, it is submitted that the
scientific information was included among a broad range of possible
alternatives to therapy in subsequent patent filings made in the United States,
as well as in academic papers.
[86]
Dr. Martin bears the burden of establishing
portions or all of the records at issue are confidential and must provide “actual direct evidence of the confidential nature of the
remaining information which must disclose a reasonable explanation for
exempting each record. Evidence which is vague or speculative in nature cannot
be relied upon to justify an exception under subsection 20(1)” (Brainhunter
at para 25).
[87]
For the purposes of the exception created by
paragraph 20(1)(b), the exemption from disclosure, as explained in Brainhunter,
above, at para 21, requires that the information in question meet all four of
the following criteria:
21 [T]he Act provides for an exemption to
disclosure for information which has been supplied by a third party to a
government institution, and which is confidential commercial information that
has consistently been treated in a confidential manner. The information must
be: (1) financial, commercial, scientific or technical information as those
terms are commonly understood; (2) confidential in its nature, according to an
objective standard which takes into account the content of the information, its
purposes and the conditions under which it was prepared and communicated; (3)
supplied to a government institution by a third party; and (4) treated
consistently in a confidential manner by the third party (citation
omitted).”
[Emphasis added]
[88]
On these facts there can be no disagreement that
the information in question meets the first and third criterion. I am satisfied
that the disputed information that Dr. Martin seeks to have exempted can be
commonly understood to be technical, where relevant, in that it relates to the
technical details, requirements and processes of the clinical trial that was
being conducted. Much of that same information is conversely scientific, where
relevant, insofar as it relates to the medical ingredients and properties of
the treatment solution and how it was used by the participants in the trial (Porter
Airlines Inc v Canada (Attorney General), 2014 FC 392 at para 32).
[89]
Furthermore, it is clear to me that much of the
information at issue was provided in confidence to Health Canada at their request via email by Dr. Martin and/or the Study Monitor (pages 872-897, Vol. III of
V of the Respondent’s Record, T-806-14).
[90]
Therefore, the next criterion at issue are: whether
this information was confidential; and whether the information was consistently
treated as such by the third party.
[91]
When assessing whether the information contained
in the records at issue is confidential, the Federal Court of Appeal in Canada
(Information Commissioner) v Canadian Transportation Accident Investigation and
Safety Board, 2006 FCA 157 [CTAISB] at paragraph 72, endorsed an
approach that is dependent on an affirmative finding that:
a) the content of the record be such that
the information it contains is not available from sources otherwise accessible
by the public or that could not be obtained by observation or independent study
by a member of the public acting on his own,
b) the information originate and be
communicated in a reasonable expectation of confidence that it will not be
disclosed, and
c) the information be communicated, whether
required by law or supplied gratuitously, in a relationship between government
and the party supplying it that is either a fiduciary relationship or one that
is not contrary to the public interest, and which relationship will be fostered
for public benefit by confidential communication.
[92]
The test is an objective one, and merely
repeating the words of the statute or asserting confidentiality without
concrete evidence of such treatment is not sufficient (Recall Total
Information Management Inc v Minister of National Revenue, 2015 FC 1128 at
para 29).
[93]
When I apply the legal test endorsed in CTAISB,
above, to the information which Dr. Martin seeks to have exempted, it is plain
for me to see that the information originated, and was communicated, under the
pretenses of confidence and a reasonable expectation that it would not be
disclosed. I am further satisfied that the information was supplied
gratuitously by Dr. Martin or the Study Monitor to Health Canada.
[94]
This view is supported by the evidence on
record. For example, in the email dated November 11, 2008, the Study Monitor
indicates that the information, or parts thereof, has not yet been released to
the public (page 87, Vol. III of V of the Respondent’s Record, T-806-14).
[95]
It is also apparent through a consideration of
Dr. Martin’s affidavit evidence, as well as the purportedly archived webpages
captured through the Wayback Machine, that this information was only accessible
to parents participating in the clinical trial through password protected
webpages, as discussed at paragraphs 68-69, above.
[96]
However, what remains at issue is whether this
information is found in other sources that are accessible by the public acting
on their own.
[97]
The Minister filed several affidavits sworn by Mr.
Rashid in support of its position that the information in question is available
from sources otherwise accessible by the public. In those affidavits, Mr.
Rashid attests that the information at issue is available from a multitude of
other sources, including a number of patent applications filed by Dr. Martin in
the United States, as well as a number of academic articles authored by Dr.
Martin and a variety of other online sources. Mr. Rashid’s affidavit further
indicates that the scientific information was not confidential because he was
able to find the American patent applications on the internet when he conducted
a Google search using “Dr. W. John Martin” and
the name of a medical ingredient found in the treatment solution. These United
States patent applications were provided as evidence that the information was
not confidential and was obtainable by the public.
[98]
Respectfully, I do not agree with the Minister’s
submissions on this issue. It bears reminding that neither the Applicant’s
name, the website at issue, nor the distinctive name of the treatment solution was
ever mentioned in the access to information request. Therefore, I do not find
that much of the information which Health Canada seeks to disclose could be
accessed by the general population and thus be understood to be in the “public domain.”
[99]
This information was only found after further
research online by Health Canada using information provided in confidence to
the Department, or otherwise using information that was found on the password
protected website. Dr. Martin provided evidence that it was not until page seven
of the Google search of his name that the correct Dr. Martin was even found. As
this result was only confirmed by Health Canada’s knowledge of personal
information in the Department’s possession, I do not believe that it can be
said to have been easily be obtained by observation or independent study by a
member of the public acting on his own which is the legal test.
[100] Furthermore, the scientific papers and United States patent applications
were published and filed for the purposes of treating different medical
conditions not directly related to the developmental disability being examined
as part of the clinical trial. I do not believe that the publicly disclosed use
of the scientific information at issue for the purposes of treating one medical
condition excuses the confidentiality of that information in relation to the
treatment of another medical condition. A new use for a known compound/drug
that has not been disclosed in a public manner is not public by virtue of other
publications detailing how that compound may use for a different purpose. As
the Supreme Court of Canada has instructed such a new use may well be
independently patentable and entitled to confidentiality (Shell Oil Co v
Commissioner of Patents, [1982] 2 S.C.R. 536).
[101] I support and respect the need for transparency but I do not believe
that the jurisprudence supports the lengths that Health Canada has gone in
order to support the decision to disclose the proposed package of records. Additionally,
the vagueness of the original request distinguishes this case from some of the
jurisprudence where the requests under consideration were made in reference to
named parties.
[102] I find that the information was confidential and was consistently
treated as such by Dr. Martin.
[103] For these reasons I have concluded that the following records, or
parts thereof, are exempt from disclosure. Subsection 20(1)b in addition to
what is already redacted by Health Canada (para 33) or within this decision
(1)
T-1835-13
[104] Documents in the proposed release package are found at Tab E, Vol II
of Respondent’s Record and identified by release package page number not the
Respondent’s record page number.
|
65
|
•
Entire last paragraph
|
|
66
|
•
All information not already redacted under
other sections
|
|
67
|
•
All information not already redacted under
other sections
|
|
107
|
•
All references to the treatment solution used
in the clinical trial, including any constituent ingredients
•
All references to the use of the study
protocol and/or devices used as part of the clinical trial
|
|
108
|
•
All references to the treatment solution used
in the clinical trial, including any constituent ingredients
•
All references to the study protocol and/or
devices used as part of the clinical trial or application
|
|
109
|
•
The entire page
|
|
110
|
•
All references to study protocol and/or
devices used as part of the clinical trial
|
|
127
|
•
All references to the treatment solution used
in the clinical trial, including in the email subject line
|
|
135
|
•
All references to study protocol and/or
devices used as part of the clinical trial
|
|
276-288
|
•
The entire article
|
|
384
|
•
The entire page
|
|
385
|
•
All references to study protocol and/or devices
used as part of the clinical trial
|
(2)
T-806-14
[105]
Documents in the proposed release package are
found at Tab A, Vol III of V of the Respondent’s Record and identified by
release package page number not the Respondent’s record page number.
|
4
|
•
All references to the treatment solution used
in the clinical trial
•
All references to study protocol and/or
devices used as part of the clinical trial
|
|
11
|
•
All references to the treatment solution used
in the clinical trial
•
All references to study protocol and/or devices
used as part of the clinical trial.
|
|
13
|
•
All references to the treatment solution used
in the clinical trial
•
All references to study protocol and/or
devices used as part of the clinical trial
•
Same email included in 4
|
|
23
|
•
All references to the treatment solution used
in the clinical trial, including any constituent ingredients
•
All references to study protocol and/or
devices used as part of the clinical trial
|
|
74
|
•
All references to the treatment solution used
in the clinical trial
•
All references to study protocol and/or
devices used as part of the clinical trial, including in the email subject
lines
|
|
75
|
•
All references to study protocol and/or
devices used as part of the clinical trial, including in the email subject
line
|
|
76
|
•
All references to study protocol and/or
devices used as part of the clinical trial, including in the email subject
line
•
Entire content of 03/12/2008 email (last
paragraph on page)
|
|
77
|
•
All references to the treatment solution used
in the clinical trial
•
All references to study protocol and/or
devices used as part of the clinical trial, including in the email subject
line
|
|
84
|
•
All references to study protocol and/or
devices used as part of the clinical trial
|
|
87
|
•
All references to the treatment solution
•
Entire content of 28/11/2008 email (last two
paragraphs on page)
|
|
88
|
•
Entire record
|
|
94-106
|
•
Entire range of records
|
|
117
|
•
All references to the treatment solution used
in the clinical trial,
•
All references to study protocol and/or
devices used as part of the clinical trial
|
|
119
|
•
All references to study protocol and/or
devices, including fees associated with the trial
|
|
122
|
•
Entire record
|
|
235
|
•
Entire record
|
|
236
|
•
Entire record
|
|
239
|
•
Entire record
|
|
243
|
•
Entire record
|
|
263-265
|
•
Entire range of records
|
|
266
|
•
Entire record
|
|
269-275
|
•
Entire range of records
|
|
340
|
•
All references to study protocol and/or
devices used as part of the clinical trial
|
|
417
|
•
Entire record
•
All references to trial study protocol and/or
devices
|
|
418-442
|
•
Entire range of records.
|
D.
Paragraph 20(1)(c) - Prejudicial Information
[106]
Dr. Martin does not directly cite this provision
but argues that the disclosure of the information in question is “contrary to the spirit and intention of the [Access Act],”
and proposes that the disclosure of the records in question would “besmirch the names” of the Applicant and the Study Monitor,
and may impair future research endeavours that he wishes to pursue.
[107] The Minister takes the position that none of the information in
question falls under the exemption provided in paragraph 20(1)(c), which again requires
proof of a reasonable expectation of probable harm. The Minister argues that
the possibility of material financial loss or prejudice to Dr. Martin’s
competitive position is not enough and must be established beyond that which is
possible or speculative (Merck Frosst, at paras 192-206; Saint John
Shipbuilding Ltd at paras 3-8; Oceans Ltd, above, at para 61).
[108] The Minster submits that Dr. Martin has failed to establish this
link and that his affidavit attesting to the possibility of harm is not enough
to establish a cause between proposed disclosure and the alleged harm with
detailed and convincing evidence.
[109] I agree with the Minister’s submissions in this respect. A third
party claiming an exemption under paragraph 20(1)(c) of the Access Act
must show that the risk of harm is considerably above a mere possibility,
although stops short of having to establish on the balance of probabilities
that the harm will in fact occur (Merck Frosst at para 199).
[110] With regards to showing that risk of harm is considerably above a
mere possibility, the burden imposed on Dr. Martin under this provision was
well explained by Phelan J. in AstraZeneca Canada, Inc v Health Canada,
2005 FC 1451 at paragraph 46.
46 Recognizing the inherently speculative
nature of proof of harm does not however relieve a party from putting forward
something more than internally held beliefs and fears. Evidence of reasonably
expected results, like forecasting evidence, is not unknown to courts and there
must be a logical and compelling basis for accepting the forecast. Evidence of
past documents of information, expert evidence, evidence of treatment of
similar evidence or similar situations is frequently accepted as a logical
basis for the expectation of harm and as evidence of the class of documents
being considered.
[111] Therefore, it is incontrovertible that there must be a clear and
direct linkage between the disclosure of specific information and the harm
alleged. In this case, there appears to be little evidence beyond Dr. Martin’s
own affidavit evidence. As a result, I am not of the opinion that any documents
ought to be exempted on this ground.
VIII.
Conclusion
[112]
The applications will be allowed in part in
accordance with these reasons. The confidential records filed in these
applications will remain sealed as previously ordered.