[INSERT DATE]
The Honourable Jane Philpott, M.P.
Minister of Health
70 Colombine Driveway
Tunney's Pasture
Postal Location: 0906C
Ottawa, Ontario K1A 0K9
[INSERT RETURN ADDRESS]
Re: Request for information pursuant to the Food and Drugs Act, s.
21.1(3)(c), in order to protect and promote human health and public safety
Dear Minister,
I, [INSERT NAME], am writing to formally request access to all unpublished
information, including clinical trials and other investigational studies, pertaining to
the safety and effectiveness of [INSERT THERAPEUTIC PRODUCT NAME(S)]. I
understand that recent changes to Canada’s Food and Drugs Act, R.S.C. 1985,
c. F-27 [hereinafter “the Act”] give you the power to make such information
available in certain circumstances.
More specifically, I understand that the Act gives you the explicit power to
disclose “confidential business information” and that Health Canada has taken
the position that this phrase extends to unpublished information about a drug’s
safety or effectiveness. I must state for the record that I disagree with this
interpretation. Information about a drug’s safety and effectiveness should be
understood as clinical – not business – information. However, unless and until
this is clarified by regulations or compelled by a Court decision, I request that you
use the power to disclose confidential business information under section
21.1(3)(c) of the Act.
To invoke your discretion under section 21.1(3)(c) of the Act, I understand that
two conditions must be met. The first condition is that I must be “a person who
carries out functions relating to the protection or promotion of human health or
the safety of the public.” I meet this condition because I: [DESCRIBE YOUR
RELEVENT ROLES WHICH MIGHT INCLUDE PROVIDING HEALTHCARE,
CONDUCTING RESEARCH OR REPORTING ON HEALTH ISSUES]
The second condition is that the purpose of disclosing the information must be
“related to the protection or promotion of human health or the safety of the
public”. My request also satisfies this condition because [DESCRIBE WHY
REQUESTING INFORMATION AND HOW INTEND TO USE, e.g. REVIEW ALL
EVIDENCE RELATING TO A THERAPEUTIC PRODUCT TO INFORM
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PRESCRIBING DECISIONS AND PATIENTS; CONDUCT META-ANALYSIS OF
PUBLISHED AND NON-PUBLISHED EVIDENCE PERTAINING TO THE
THERAPEUTIC PRODUCT(S); REPORT ON HEALTH ISSUES CONNECTED
TO THE THERAPEUTIC PRODUCT(S)].
Specifically, the information I am requesting is as follows: [INSERT
DESCRIPTION OF INFORMATION SOUGHT, e.g. RESULTS OF CLINICAL
TRIALS AND OTHER INVESTIGATIONAL STUDIES INVOLVING THE
THERAPEUTIC PRODUCT THAT HAVE NOT BEEN PUBLISHED TO DATE;
ALL CLINICAL STUDY REPORTS PERTAINING TO THE THERAPEUTIC
PRODUCT; UNPUBLISHED ADVERSE EVENTS RELATING TO THE
THERAPEUTIC PRODUCT, ETC.]
Consistent with best research practices, standards of research ethics, and the
European Medicine Agency’s policy on publication of clinical data, I will agree to
the following terms and conditions in exchange for the above information about
[INSERT THERAPEUTIC PRODUCT NAME(S)]:
1. I will not use or disclose the information for any “commercial purposes”
with the proviso that “commercial purposes” does not extend to
comparative effectiveness research involving two or more therapeutic
products;
a. For greater clarity, I will not use or disclose the information to
support an application for market approval of another therapeutic
product or any extension or variation of such a market approval;
2. I will not attempt to re-identify any individuals that participated in the
clinical trials, published or unpublished, or other investigational studies
and I will take reasonable steps to ensure the privacy of those individual
participants is, in any event, maintained;
3. I will only use or disclose the information for the purpose of protecting or
promoting human health or the safety of the public; specifically, in view of
the purpose of my request as described above,
a. I will use or disclose the information, as necessary, in order to carry
out research and/or analyze the information, while maintaining the
privacy of individual research participants;
b. I will use or disclose the information for the purposes, as
necessary, to disseminate my research findings to researchers,
health care professionals, and other audiences through
presentations at conferences and publications in scholarly journals,
while maintaining the privacy of individual research participants;
c. I will use or disclose the information, as necessary, in order to
inform patients about the risks and benefits of the therapeutic
product(s), while maintaining the privacy of individual research
participants; and,
4. I will inform Health Canada, in a timely fashion, about any findings I make
regarding the information and the safety and effectiveness of the
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therapeutic product(s), including providing a copy of any conference
presentation or journal publication no later than two weeks after a
presentation/publication;
a. For greater clarity, informing Health Canada of my research
findings is in addition to, not a substitute for, making them publicly
available, whether by disclosing my findings to others through
conference presentations, scholarly journals, and/or discussions
with colleagues, health care providers, news media, and individual
patients.
I trust that you will invoke your discretion pursuant to this essential new power in
Canada’s Food and Drugs Act to make the foregoing information available in a
timely fashion. The law gives you the power to make unpublished safety and
effectiveness information available, but ensuring the safe and effective use of
therapeutic products depends on physicians, researchers, and others being able
to independently scrutinize the information that Health Canada holds. I trust you
will use your power under the law to enable me to contribute to that goal.
Sincerely,
[INSERT NAME/TITLE/AFFILIATION]
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