Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 19 - Evidence - September 25, 2014
OTTAWA, Thursday, September 25, 2014
The Standing Senate Committee on Social Affairs, Science and Technology met
this day at 10:30 a.m. to study Bill C-17, an Act to amend the Food and Drugs
Senator Kelvin Kenneth Ogilvie (Chair) in the chair.
The Chair: Welcome to the Standing Senate Committee on Social Affairs,
Science and Technology.
I am Kelvin Ogilvie, senator from Nova Scotia and chair of the committee. I
will ask my colleagues to introduce themselves.
Senator Seidman: Judith Seidman from Montreal, Quebec.
Senator Stewart Olsen: Carolyn Stewart Olsen, New Brunswick.
Senator Nancy Ruth: Nancy Ruth, Toronto, Ontario.
Senator Seth: Asha Seth, Toronto, Ontario.
Senator Enverga: Tobias Enverga, Toronto.
Senator Chaput: Maria Chaput, Manitoba.
Senator Eggleton: Art Eggleton, senator from Toronto, deputy chair of
The Chair: Thank you. Welcome to our guests. We are dealing with Bill
C-17, An Act to amend the Food and Drugs Act. The short title is the
``protecting Canadians from unsafe drugs act,'' known as Vanessa's law.
Before I get to our witnesses, we have a presentation available to us that
has been prepared to this point only in English. Do I have agreement from the
committee to circulate that in the one language at this time?
Senator Chaput: Have witnesses been informed of the committee's policy
requiring that all documents be provided in both official languages?
The Chair: Yes.
Senator Chaput: They know this?
The Chair: Yes.
Senator Chaput: In that case, permission granted.
The Chair: Unfortunately, it is not always possible.
Hon. Senators: Agreed.
The Chair: Thank you, colleagues.
We have three witnesses with us this morning on this very important bill. I
will identify them as I ask them to make their presentations. Having had no
urgent requests to go first, I will go by the order in which they appear, which
will put Mr. Attaran on the spot immediately. He has made a daring dash to our
committee, given the vagaries of the opportunities in traffic. Welcome back to
the committee, and please proceed.
Amir Attaran, Canadian Research Chair, Population Health and Global
Development Policy, University of Ottawa, as an individual: Thank you for
soliciting my input on Bill C-17. While the good intentions of this bill and the
momentum to pass it without amendment are obvious, I find myself a bit
frustrated at the fact that, with some small amendments, Bill C-17 could be made
so much better. So rather than speak of the bill's strengths, which exist for
sure, as others have, I will discuss two obvious failures with the bill — I
think that's how I can be more helpful to you — in the hope that Parliament
chooses quality above haste.
First, Bill C-17 is, in one respect, a troubling step backward. It weakens —
not strengthens — Canada's penal response to strict-liability pharmaceutical
crimes. The criminal fines are going up a lot, but criminal imprisonment is
going down; thus, an organized criminal convicted of dealing in unapproved or
adulterated medicine who does so purely for the money today faces maximum
imprisonment on indictment of three years under the Food and Drugs Act, but this
drops to two years if Bill C-17 becomes law.
For a government that prides itself on being tough on crime, it looks like
somebody goofed on this one. Parliament passed imprisonment of 14 years for
persons who traffic counterfeit money. Is Parliament really trying to say that
if some punk counterfeits a $20-bill, that's bad and worth 14 years, but if
organized criminals counterfeit a cancer medicine or a heart medicine, then
under Bill C-17, two years is enough? It doesn't seem logical.
Amending our criminal penalties is the right thing to do. The current maximum
of three years imprisonment for medicine crime is inexcusably lenient. A
responsible bill would step up imprisonment for offences like medicine
falsification to the 14 years of money counterfeiting, if you think that fake
medicine is at least as bad as fake money. To step down to two years, as clause
9 of Bill C-17 does, probably inadvertently, is shamefully inappropriate, so you
have to amend that.
Second, Bill C-17 attempts to update Canada's obsolete definition of a
medical ``device,'' but it makes a hash of it by being simultaneously too broad
and too narrow. For example, a medical ``device'' as defined under paragraph
2(1)(b) includes anything used in modifying a body structure. Well, an
earring modifies a body structure, after all, but does Parliament really want
Health Canada regulating earrings as medical devices? I think that's probably
not your intention and so it's too broad.
But conversely, on the side of too narrow, Bill C-17's definition of a
medical ``device'' fails to include all the extremely important gizmos that
hospitals use to keep everything sterilized and keep infections down. I'm
talking about equipment like autoclaves, ultraviolet lamps and ethylene oxide
sterilizers. These devices sterilize and cleanse other devices that enter your
body, like surgical instruments, gynecological probes, colonoscopes and so
Clearly Health Canada should regulate the sterilizing equipment, too. There
are public health reasons to do that, but the proposed definition omits this.
Likewise, the definition omits the non-physical aspects of medical devices
like software, which is foolish when so many medical devices these days are
increasingly computerized. Think of an insulin pump or a pacemaker. Unregulated
unsafe software can kill you the same as unsafe hardware. That's the point. And
you don't want to be hitting control-alt-delete on your pacemaker.
The World Health Organization and the European Union have better, although
still not perfect, definitions of medical devices. I would amend Bill C-17 in
the direction of the WHO or EU definitions, because the definition that is now
in Bill C-17 is obsolete by decades already. It stinks; it's not a good
I will close there. I am sorry if I made it seem that the perfect is the
enemy of the good. That's not my intention, but if you want Bill C-17 to be
great and not just okay, then you still have some work to do here.
The Chair: Thank you.
I will turn to Professor Elaine Gibson from Dalhousie University.
Elaine Gibson, Associate Professor, Health Law Institute, Faculties of
Medicine and Law, Dalhousie University, as an individual: Thank you.
I'm going to urge three ways specifically in which Bill C-17 can be enhanced.
I think it's a great bill. I think it's important that it goes ahead, but I
would really like enhancement.
One of my areas of expertise is tort law, and that's law regarding injury. So
my comments are grounded in the potential for lawsuits against Health Canada and
how best to avoid them, while still having the teeth and law to accomplish what
There are three measures: First, incorporate a greater range of adverse
events; second, ensure powers of suspension and recall operate in graduated
fashion; and third, exempt Health Canada from liability.
I'll deal with those one by one. On incorporating a greater range of adverse
events, the language of the bill refers to ``injury to health.'' You will recall
the incident last year regarding the faulty packaging of the birth control
medication Alysena, in which case Canada's delay in response may have led to a
great number of unplanned pregnancies. The initial view was that this did not
constitute a serious adverse health consequence as pregnancy is a natural
phenomenon. It was eventually accepted that if a particular woman should not get
pregnant specifically for medical reasons — if carrying a fetus could cause
injury to her — this would constitute such an adverse consequence. This led to
the level of classification of risk being increased, but not simply if a woman
was opting not to get pregnant for non- medical reasons. That wasn't the reason
for acting. In other words, pregnancy was at first blush a ``lifestyle choice,''
as paradoxical as that is, and not a serious adverse event.
I propose that the wording of Bill C-17 be altered to incorporate explicit
language that deals with situations of product mislabelling or mispackaging. I
have, in the document before you, suggested specific wording as to how to
I understand that Health Canada is of the view that the wording in Bill C-17
at present will be adequate to include such situations as unplanned pregnancies.
However, it's my contention that there is much benefit to be gained from having
clarity and nothing to be lost. It's preferable to err on the side of being
My second point is about ensuring that the powers of suspension and recall
operate in a graduated fashion. Janet Currie appeared before this committee
yesterday and referred to the power of recall being, if I understood correctly,
a nuclear option. I might use the terminology of a sledgehammer approach. I
think it gets at the same idea. She urged that graduated measures be included,
such that recall is a last option in the chest of tools available to Health
Canada. However, she indicated she didn't have the legal expertise to design
these graduated measures. I will provide concrete suggestions as to how to
The regulations under the Food and Drugs Act presently include suspension
powers. Their effect is to prevent subsequent distribution and sale by the
manufacturer for the period of suspension, but the various parties downstream do
not need to be notified and the supply does not need to be removed from pharmacy
shelves. These powers can only be exercised where the evidence is that the drug
is not safe or there is new information that it is not effective, and in a few
other narrow circumstances.
Now that the power of recall is being added and is intended to be permanent,
I suggest the two types of powers need to be reconciled. Suspension should be
the milder type of intervention and the power of recall should be a step up and
should include a higher standard. The two don't work in harmony under Bill C-17
because the standard for suspension is higher in respect to the test to be met.
In other words, it's easier to establish what Bill C-17 requires for recall than
to establish what the current food and drug regulations require for suspension,
for example, that the drug is not safe as shown by evidence. That's a relatively
How should this be accomplished, the reconciling of the two and the graduated
approach? Assuming that the present Bill C-17 recall provisions stay as drafted,
there are relatively simple ways to accomplish this. An added ground for
suspension should be ``where the minister suspects that a therapeutic product
presents a serious or imminent risk of injury to health'' instead of
``believes,'' which is the wording in Bill C-17 and that can and should be the
standard or the recall.
The current regulations on suspension could be amended accordingly or
preferably the powers of suspension should be added to Bill C-17 so it is clear
that suspension and recall function in harmony, in graduated fashion.
My third point is about urging that Health Canada receive exemption from
liability under the statute for measures taken in good faith. I'm not sure if
I'm close to being out of time, so I may abbreviate my comments. You can read
them, but they're basically that pharmaceutical corporations are among the most
powerful corporations in the world and their yearly revenue of the top 10 is
higher than the total revenue of the Government of Canada. I am worried about
the possibility of lawsuits and I urge that there be included specific wording
on exemption from liability for acting against pharmaceutical corporations, such
as the powers of recall and other powers in Bill C-17.
I understand that it's not customary for the federal government, as opposed
to some other governments, to include such waivers of liability but given the
dramatic powers of pharmaceutical corporations and their high tendency to bring
lawsuits against governments, I believe that this is a time for taking that
approach in the legislation and including a waiver of liability. In turn, this
will foster greater latitude on the part of Health Canada to take action even on
a precautionary basis.
I urge you to enhance Bill C-17 so that it is better at its stated mission,
protecting Canadians from unsafe drugs.
The Chair: Thank you, Ms. Gibson. I will turn to Matthew Herder,
Assistant Professor, Health Law Institute, Faculties of Medicine and Law,
Dalhousie University. I don't think that I indicated that Mr. Attaran is
Canadian Research Chair, Population Health and Global Development Policy,
University of Ottawa.
Professor Gibson is Associate Professor of Law, Health Law Institute, Faculty
of Law, Dalhousie University.
I apologize for that omission at the beginning.
Matthew Herder, Assistant Professor, Health Law Institute, Faculties of
Medicine and Law, Dalhousie University, as an individual: Thank you very
much. It's a privilege to be here. I'm going to make four quick but critical
points all about the transparency provisions now present in Bill C-17. I think
the spirit of these provisions is worthy of your strong support, but the
particulars need some work.
My first point concerns proposed new sections 21.1(2) and (3), which
respectively allow the Minister of Health to disclose ``confidential business
information'' when the minister believes a therapeutic product presents a
serious risk to human health or where the purpose of the disclosure is to
protect or promote human health or the safety of the public.
In my view, tying these powers exclusively to confidential business
information is problematic. I understand the motivation. Without such an
explicit power, manufacturers are apt to argue that the minister cannot disclose
that kind of information because it's their intellectual property. Indeed, it
has long been standard practice for manufacturers when they submit their
applications to Health Canada to do so under a cover letter that claims all the
material and data is confidential business information. However, to my
knowledge, that assertion has never been tested fully in a court. Yes, the
common law definition of confidential business information is broad and Canadian
courts have said that manufacturing processes can qualify as trade secrets, a
closely related form of intellectual property, but no court has said that drug
safety and effectiveness information generated in the course of a clinical trial
is confidential business information as opposed to patient or clinical
information. I urge you not to give credence to that claim.
Further, Canada is under no obligation to treat information about the safety
and effectiveness of a drug derived from patients as confidential business
information. International treaties only require Canada to protect data against
unfair commercial use, which Canada has arguably already done and even that
obligation can be ignored where disclosure is necessary to protect public
Other jurisdictions, including the United States and European countries, are
signatories to these treaties and yet regulatory authorities in those
jurisdictions routinely disclose far more information than Canada's regulator.
Therefore, I urge the committee to amend those clauses of the bill such that the
minister has the power to disclose information about the safety and
effectiveness of a therapeutic product, as well as confidential business
information, but defined more narrowly as information about manufacturing
processes or financial information.
My second point relates to proposed new section 21.1(2) only. At present,
this new power to disclose information to prevent harm to people is
discretionary. That may be consistent with legal drafting conventions, but given
the regulator's track record of not disclosing information despite ample legal
authority to do so, I think this power should be mandatory.
In Rubin v. Canada, 2001, the only Canadian case where the minister
was asked to disclose information about a drug on public interest grounds, the
minister chose not to do so; and the Federal Court of Appeal deferred to that
decision. In short, the minister in the past has seldom exercised his or her
existing discretion in favour of transparency; so why should we assume that's
about to change suddenly? The power outlined in proposed new section 21.1(2)
should be mandatory.
My third point: To whom the minister can disclose information pursuant to
proposed new section 21.1(3) is vague. This measure is intended to give the
minister power to disclose information to protect or promote human health,
provided the information is disclosed to a government, someone that the minister
wants advice from, or a person who carries out functions relating to the
protection or promotion of human health or the safety of the public. Who falls
under that last category is not obvious. Yet, one of the main reasons behind all
the calls for greater transparency in this country, and in others, is for us to
learn more by discovering and interrogating knowledge that has been
Transparency is necessary to allow independent scrutiny by independent
researchers of this kind of data. Regulators don't have the necessary expertise
or the resources to do this. Virtually all of the studies that have shown there
is a worrisome gap between what is known publicly about a given drug and all of
the information about that drug that may be in unpublished sources have been
carried out by those kinds of independent researchers. I submit that independent
researchers must fit within the scope of that provision, and you should amend
the bill to make that abundantly clear.
My fourth and final point: We don't just need better wording. We also need to
strictly enforce the new transparency expectations that Bill C-17 places upon
manufacturers. That's the exact phrase that members of this committee used in
their November 2012 report entitled Canada's Clinical Trial Infrastructure: A
Prescription for Improved Access to New Medicines. Based on evidence from
countries where transparency measures are already in place, my submission to you
is that Bill C-17 will not do enough to strictly enforce transparency. Bill C-17
would make it an offence, punishable by imprisonment or monetary fines, not to
comply with transparency obligations. Yet evidence from the United States, a
place where similar penalties have been place since 2007, suggests that such
penalties are not enough to ensure compliance. According to one study, over
three quarters of clinical trials registered on ClinicalTrials.gov failed to
provide results within the one-year statutory time frame.
I therefore suggest a modified enforcement strategy. Failure to comply with
transparency obligations should still be subject to monetary fines and/or
imprisonment. However, Bill C-17 should also tie transparency obligations to a
therapeutic product's market authorization. Bill C-17 already includes a
proposed amendment to the Food and Drugs Act that would require manufacturers to
comply with any terms or conditions attached to their market authorization. This
power should not be used on occasion. Rather, every drug approval for which
transparency obligations have not been met at the time of the approval should
carry a condition requiring the manufacturer to meet those obligations or else
trigger a suspension of the notice of compliance.
To disrupt the norm of confidentiality long-practised at Health Canada, it's
imperative that Bill C-17 include broadly worded mandatory transparency powers
and strict enforcement measures as I've identified and respectfully submit for
The Chair: I will open the floor to questions and remind the committee
that this session will terminate no later than 11:30 a.m.
I will begin the questions with the sponsor of the bill in the Senate,
Senator Seidman, to be followed by the Deputy Chair of the Committee, Senator
Senator Seidman: Thank you very much for your very clear, crisp and
informative presentations. Ms. Gibson, you put forward three well-delineated
proposals, one being to incorporate a greater range of adverse events; so we're
talking about that definition of ``serious or imminent risk of injury or
death?'' Is that correct?
Ms. Gibson: A clarification of the wording at present, yes.
Senator Seidman: Exactly. You proposed a wording, and perhaps the
other two witnesses may have something to say on this as well. Are there
examples of criteria or definitions used in other jurisdictions or within the
scientific literature to determine these parameters of serious or imminent risk
Ms. Gibson: The quasi-definition of ``serious or imminent risk of
injury'' comes mostly through the courts, to my mind, through negligent actions
and the way that they can be defined. Other than that, I don't know of a
jurisdiction that has clear definitions. Do either of you know? No.
It may not be possible, to be honest, to define more precisely what a serious
risk is or what an imminent risk is. It ends up being interpreted on the spot.
Mr. Attaran: That's right; it ends up being interpreted on the spot.
That is why tweaking those might not change things much in reality. The reality
is that the minister gets, as Professor Herder said, an enormous amount of
discretion. For my comfort, it is too much discretion, to be honest. The cases
in which the court would likely interfere with the minister and say, ``Your
refusal to disclose information is unreasonable because there is too great a
health risk'' would be few. As long as the minister has this enormous zone of
discretion to make or not make disclosure, I don't think changing the wording
slightly would take you out of that zone; and the court would look at a case in
much the same way. I think we probably all agree on that.
Certainly, I want to agree with Professor Herder when he says that this is a
problem. If the minister chooses to sit on information that Canadians ought to
have about a dangerous medicine in the marketplace, and we saw that with Apotex
only about a week ago, then there really isn't any judicial recourse that works.
Ms. Gibson: If I may finish on that, my suggestion is not for a change
in the definition but for one point of clarification that makes it clear that
the definition includes mispackaging and mislabelling if it leads to the serious
Senator Seidman: That's appreciated; thank you.
I'll pursue the next point you put forward about this very complicated
standard that is higher for suspension than it is for recall, if I understood
what you said correctly. You talked about using the regulations to amend the way
we define ``suspension.'' Are you suggesting that we could deal with the problem
you present — this graduated step-like process, suspension and recall — through
Ms. Gibson: I referred to that because the suspension powers are
currently in the regulations. It's more ideal, to be honest, for it to be
comprehensive as part of Bill C-17 so that it's clear on the surface that it is
a package of graduated powers. However, I know that it's simpler to amend the
regulations than to change the bill at this point. That's why I suggest that
either route accomplishes at least a graduated approach, which is what I'm most
Senator Seidman: Yes, and that's helpful. As we heard yesterday, the
Food and Drugs Act desperately needs to be changed. It has been 50 years since
anything has been done. As we now face the situation, of course we can't be all
things to all people, but we want to do the very best for Canadians in terms of
their safety and health.
We need to know what we absolutely need to deal with in this bill right now
and what we could deal with either in regs or in future bills. That's the big
issue here, so I appreciate that response a lot.
Do I have one more?
The Chair: As the sponsor of the bill, you have one more; but I
caution other colleagues.
Senator Seidman: Your last measure about the liability for the health
minister, which I appreciate very much, and I'm wondering: Is there any other
mechanism? Because it is not customary to put that kind of thing in a piece of
legislation, indeed. Given your expertise, I'm asking you specifically this
question: Do you see any other mechanism to deal with that liability, other than
in the legislation itself?
Ms. Gibson: Otherwise it ends up going to court once there is a
lawsuit, so that's the other mechanism. To be honest, I don't see a harm in
including it, even if it's not customary. This is an example of where it would
be highly appropriate. It's not uncommon in certain provincial legislation. It
may be uncommon for the Government of Canada to use it.
Senator Seidman: Thank you so much.
Senator Eggleton: Thank you to all three of you for being here. I want
to come to the issue of transparency, because that has occupied a lot of our
time in our pharmaceutical study, starting off with clinical trials, where we
said there should be a registry and we indicated that it should have a lot more
information than what has ever been provided. But we've also said, in terms of
the life cycle approach, there needs to be disclosure in many other points of
time. I would add to that that I don't think our transparency should be any less
than it is in the European Union, or the FDA in the United States, or whether
the FDA is planning the amendments that, in fact, it is planning in the United
When I look at this bill, I'm hearing that this is going to accomplish that;
it's going to create as much transparency as anybody else has; it's going to do
the trick in terms of giving the practitioners and the public the kind of
information they need. But then I look through the bill and I see a lot of the
word ``may,'' the minister may do this or the minister may do that. There are
some more restrictive kinds of words that were added by the House of Commons
health committee, which used the words ``shall'' or ``ensure.'' But my
impression is that the overriding terminology in here in terms of putting this
greater disclosure in place is the word ``may.'' To me, that suggests ``may or
may not,'' that there could be exemptions. There is clear direction, I think, in
some respects, but it still leaves a lot of discretion for the minister in terms
of the regulation.
What are your thoughts on that? Is that adequate or does this need to be
toughened up a little bit more in terms of ``shall'' or ``ensure'' as opposed to
Mr. Herder: I appreciate the comment, and I credit the committee in
the House of Commons for adding a number of measures around transparency,
because when it was originally introduced, there was nothing. It's a little bit
complicated, but right now there is both ``shall'' and ``may'' in different
places in the bill, as you pointed out. There is a ``shall'' for manufacturers,
``shall disclose prescribed information, in the prescribed manner, in the
prescribed time.'' So that depends entirely on what the regulations say about
what that includes.
Frankly, I think that leaves a lot of room. I understand that Health Canada
is thinking about defining that in regulations and moving forward on that, but
we have pretty clear precedents for the kinds of information we need. I would
prefer, as I advocated previously, to specify that in the legislation itself. So
one thing is that the ``shall'' applicable to manufacturers should be more
clearly delineated. If not, those regulations need to come quickly.
In terms of the discretionary transparency provisions, what I tried to
indicate in my remarks is that there should be no discretion. When the minister
believes it's necessary to disclose information to prevent human health from
suffering, to prevent injury, it should not be a ``may''; it should be a
``shall'' disclose, under 21.1(2).
When it comes to disclosing information when there isn't necessarily that
risk, but you want to get independent scrutiny of the information because the
regulator can't do that work, for example, then I think there's maybe room for
discretion. So 21.1(3), I think the ``may'' might be appropriate in that case. I
hope that helps.
Mr. Attaran: Let me have a kick at this can in a somewhat different
way. Hypothetically, let's pretend Bill C-17 doesn't exist, hasn't been
introduced yet; we're just having a talk about transparency in drug regulation.
The reality is that today, in Canadian law, there is no prohibition on the
minister, for the most part, disclosing confidential business information, if
the minister thinks that's necessary to protect human life or animal health,
what have you. The minister can, as we sit here today, without Bill C-17,
disclose confidential business information if she believes that's in furtherance
of health protection. There might be some small exception for trade secrets, but
other than that, the minister can, and may, to adopt your word, do so right now.
If you legislate Bill C-17, which takes that present reality and simply puts
it on the page, what have you actually changed? That's the question I pose. If
it is your belief that greater transparency should come to pass, that the
current situation is not transparent enough because of the way that all
ministers who have held the post — not Ms. Ambrose; all of them — have exercised
their discretion, then you probably need different wording in Bill C-17.
Senator Eggleton: Do you want to take it on, Ms. Gibson?
Ms. Gibson: Which is the ``shall'' wording, to follow along from
Amir's comments. Ministers are reticent to bind themselves with ``shall''
language, and the act is worded in the way it is so that the minister has
discretion. That's the use of the ``may'' language as opposed to the ``shall''
language. Any ``shall'' language which compels the minister to act then requires
the resources behind it. It's a very effective tool to ensure that government
has the obligation clearly stated and meets its obligation. So I'm entirely
supportive of ``shall'' language, as opposed to ``may,'' when it comes to
actions of the minister.
Senator Eggleton: Sounds like all three of you, then.
Ms. Gibson, can I take up your exemption from liability provision here? I
know that big pharma can get very litigious. EIi Lilly, I think, has a lawsuit
going now against the Government of Canada for $500 million on some patents that
were refused, which is not quite the same thing as a recall. But there are other
cases where, under NAFTA or other trade provisions, there has been litigation.
So they don't seem to be shy to do that kind of thing, and maybe that fits in
with what you're advocating here.
But I've also heard it said that if there's no light — I may not have this
right — but if there's no light between the U.S. and the Canadian practices, for
example under NAFTA, then that may not be a problem at all. If, in fact, the
disclosure or the recall provisions or whatever are similar in both countries,
it may not be an issue; there would have to be something that the Canadians were
doing differently and more to the disadvantage of the pharmaceutical company
than what the Americans are doing. Is that your understanding of it?
The Chair: Can you focus your answer, please? I'm going to have to
bring this to an end.
Ms. Gibson: Sure. I think that whether or not the minister in the
States acts is irrelevant to whether the Minister of Health for Canada should
act. So if the Minister of Health for Canada acts on a precautionary basis,
let's say, and issues a recall, without the evidence being clearly laid out yet
but on a precautionary basis, based on a little bit of evidence at the time,
then, irrelevant of what has happened in the U.S., the grounds for a lawsuit are
laid, and that's where the Government of Canada becomes vulnerable to big
lawsuits. An exemption from liability carries no harm with it, that I know of,
and lots of advantages.
Senator Stewart Olsen: Thank you for your presentations. I just have
brief questions. I want to deal with the recall- versus-suspension issue and the
I'm of the opinion, and it's maybe because I don't understand all of this as
well as you all do, but if there are enough questions to suspect the selling of
a drug, then surely it should be recalled from the market. Am I wrong? I
understand there are things, but I would rather err on the side of caution than
doing it in a graduated fashion. Sometimes, if you don't recall a drug, and the
sale is suspended, a little pharmacy in northern New Brunswick may still be
selling that drug. I just want to get your input on that issue.
Mr. Attaran: In most cases, you're probably right, but I can think of
some exceptions that could exist.
Senator Stewart Olsen: I'm sure.
Mr. Attaran: When you claw back a medicine from the marketplace, from
the shelves and from users, you're doing so because you want to mitigate a risk
that you think exists in that medicine. Let's say there was a manufacturing
error, and you don't want to expose a patient to that, you mitigate the risks by
clawing it back.
But bear in mind that when you do that, you're also creating risks. A patient
who may be accustomed to taking that medicine diligently twice a day to control,
say, hypertension might have that treatment interrupted.
So this becomes very difficult to generalize about. For some medicines, you
won't want to interrupt continuity of therapy, so you'll wield the recall more
carefully than for others.
The Chair: Professor Gibson, please just answer this and we'll move to
our second question.
Ms. Gibson: There's a difference between suspension and recall in that
recall is meant to be permanent and suspension can be for a period of time. So
there might be reason to suspend the distribution of a product for a brief
period of time.
Senator Stewart Olsen: Is that in stone, though? Recall does not have
to be permanent but it should be, in my opinion. The minister should have the
ability to recall a drug from the market.
Ms. Gibson: Should have the authority to do that, yes.
Senator Stewart Olsen: In the interests of time, I can pass on my
The Chair: Are you sure? I was just trying to get to your next
Senator Stewart Olsen: It's just very brief and is in regard to the
transparency provisions. You want all of the research and all of the studies
published so that we may not miss something. But how in the world does it happen
that Health Canada would have all of the studies that are done, which could be
year upon year? I know it's not an ideal situation, but are those expectations
maybe a little unrealistic?
Mr. Attaran: Remember my comment that Bill C-17, for all the good that
it's trying to do — no one is doubting the good intentions — was basically
decades obsolete before it was born. In other parts of the world, the sort of
transparency you have just described about clinical studies and about adverse
events exists. There are even instances where some pharmaceutical companies —
GlaxoSmithKline comes to mind — have adopted transparency in clinical trial
results that go above and beyond the laws of the countries in which they
What is frustrating to me is that the transparency provisions of Bill C-17
get nowhere near the global best practice — whether it's a best practice defined
by companies themselves, a best practice in law in the United States through the
FDA or a best practice in Europe. That's my difficulty with it. Sure, the intent
is good, but the approach has been less than ambitious.
Mr. Herder: It may not be possible, or Health Canada may not have all
of the information — you're right — that exists in the world, but it should
absolutely have that power. Also, that power to disclose the information it does
have needs to be mandatory where it's to prevent a serious risk. It also should
at least be discretionary for proactive research to try to figure out what that
data they do have actually says.
Senator Stewart Olsen: I wasn't questioning that. I was questioning
how they would possibly be obligated, but we will leave that. I understand.
Senator Seth: Thank you for your presentation. My question is a little
different. Do you think that natural health products will be affected by this
regulation of Bill C-17 — like vitamins, minerals, herbal medicine, homeopathic
medication, energy drinks, probiotics and other traditional native medicines? If
so, has Canada faced a significant number of recalls for these natural health
The Chair: Can you answer the first part, because that will take it
off the table?
Mr. Herder: The definition of a therapeutic product in Bill C-17
excludes natural health products. I would add that if there was an interest in
including it — and it's not clear to me why we wouldn't want to be able to
recall natural health products — the bill wouldn't change how they're regulated;
it would just give the power of recall, for example, to be able to apply to
natural health products. If you have a natural health product that they discover
has a lot of lead in it for some reason, why would you not want to recall that?
So I think that wording could be changed to include natural health products.
Senator Seth: Can I ask another question?
The Chair: Yes.
Senator Seth: Canada has made significant recalls for natural health
products. Have these natural products resulted in life-threatening
circumstances? Can you explain that?
Mr. Herder: To my knowledge, there hasn't actually been a recall of
natural health products that the regulator has tried. Perhaps some individual
manufacturers have issued those. But right now, Health Canada could not actually
force a recall under the current law.
Mr. Attaran: This is just another example where the United States, for
example, is far ahead, because the FDA can recall all health products under its
Senator Seth: I'm not sure I'm getting the answer to what I asked. Are
they really regulated very well? I don't see it. It's a free world.
The Chair: I think it's been answered: It's not included in this bill.
It's a significant separate issue.
Senator Seth: I was looking for that. It should be included in the
Mr. Attaran: Another bill for another day.
Senator Enverga: My questions will be short. The three of you have in
your presentations mentioned a lot of enhancements you want. You mentioned
something like more penalties, more teeth and more changes to how it will work.
In your reading of Bill C-17, is it a move in the right direction, or will it
ever have any positive impact if passed without any amendment?
Ms. Gibson: I'm heartily supportive of Bill C-17 as it presently
stands. I would like it improved; I would like it enhanced, but I would think it
would be a failure if it did not pass. I think that the fact that the recall
powers are not there at present is of fundamental importance, as are some of the
transparency measures included in the bill. So I'm supportive of it.
Mr. Attaran: The answer to your question depends on which aspect of
Bill C-17 you're speaking of. On recall, it's definitely a step forward — no
doubt. On the transparency aspect, it's codifying the status quo for the most
part, so it's neither pushing forward much nor back. On the penal response, the
imprisonment response to strict liability pharmaceutical crime, it's a step
back. All this taken together means it's a mixed bag.
Mr. Herder: I would add that, in general, it's an improvement on the
status quo. But because it is, it doesn't mean that when this law comes into
force, if it does, that practices are going to automatically change overnight.
You have to make some of the powers around transparency, in particular,
mandatory and more broadly worded to change norms that have been around for
Senator Enverga: It's a good change?
Mr. Herder: If you improve the wording.
The Chair: He answered that part.
Senator Chaput: I have two very brief questions. The first one is for
Ms. Gibson. You said that the bill should contain provisions to protect the
department from legal action that could be undertaken by drug manufacturers;
does this type of legal provision exist in other countries, to your knowledge?
Ms. Gibson: I don't know the answer to that.
Senator Chaput: Fine, thank you. And what are your thoughts, Mr.
Mr. Attaran: Can you explain to me what type of legal action you are
Senator Chaput: I was referring to cases where drug manufacturers
could take a department to court when they are stopped from selling certain
Mr. Attaran: Yes, that sometimes happens here. Apotex, for instance,
had a few problems with the department two or three years ago.
Apotex sued the minister over a recall they disagreed with.
Senator Chaput: Are there legal provisions in other countries that
protect departments against this type of prosecution?
Mr. Attaran: I can't think of examples of that. But the reality is
that here where we don't have it in law — Senator Seidman said that quite
clearly it's not our custom to have it in law — when companies have tried to sue
the minister, as Apotex did because of its disagreement with regulatory action
that the minister took, they were not successful.
Mr. Herder: I would add that it's important to take into account the
resource disparity between a regulator in Canada and, say, the FDA in the United
States, where even if there haven't been lawsuits in the event of recalls —
although I suspect there might have been — the FDA can bring a lot more
resources and suing them is not the same thing as taking action against our
regulator. That difference may be relevant in why we need it and someone else
Senator Chaput: Thank you. My next question is addressed to Professor
Attaran. I thought that Bill C-17 included stricter measures for those who break
the law, but I believe you said the opposite. How is that?
Mr. Attaran: For offences involving matters of responsibility, people
may be sentenced to two or three years in jail.
Senator Chaput: In that case only, but in other cases, sanctions are
stricter, are they not?
Mr. Attaran: In other cases, I believe the maximum jail time can reach
five years. But in my opinion five years is still very weak.
Senator Chaput: But is it longer than before?
Mr. Attaran: Making counterfeit money is punished with 14 years of
imprisonment; the making of counterfeit drugs carries a five-year penalty. I do
not understand that.
Senator Chaput: Indeed, by comparison —
Senator Eggleton: The wording in here is subject to some
interpretations. There are things like the power to recall on the basis of the
minister believing it presents a serious or imminent risk of injury to health.
There's also the phrase ``health institutions.'' Do either of these definitions
need more fleshing out at this point in time or is that something where we just
wait for the regulations? Any thoughts on those phrases?
Mr. Attaran: My concern is with that definition of a device because,
in the act, once you make a ``device'' mean certain things and not others,
you're bound by that in your regulation-making power as well. The fact that
software, which is an integral part of devices, is excluded because only
tangible things are included, to me is a giant omission.
There have been cases in the United States where software that controlled
radiation machines, often used in treating cancer, was faulty and the patients
were exposed to a lethal dose of radiation. The poor medical oncologist had to
come to the patients and say, ``We were trying to treat your cancer, but we've
just irradiated you fatally. You have weeks to live.'' I want to see that
software under Health Canada's jurisdiction for obvious reasons but the way
definition of ``device'' is now, that's excluded. That's one example. If you
have poor definitions in the statute, regulation can't vary from that.
Regulation is bound by it.
Ms. Gibson: I'm urging that there be a point of clarification for
greater certainty added to the definition of eminent or serious risk to health,
the point of clarification being about mispackaging or mislabelling. That's one
improvement I want to see. I don't know if it needs to be defined more clearly
at this point.
As for regulated health care institutions, when I have pondered it, I don't
feel that the need is there to have the definition right now. I'm comfortable
leaving it to the regulations. On the other hand, it occurs to me that it may be
a reason not to include natural health products at this point in that when you
think of trying to define regulated health care institutions to include most
places where natural health products were sold, the reach could become very
broad and in a problematic way.
Mr. Herder: I think it's good that the language of a person or a
health care institution is there in broad terms because if you think about
adverse drug events, for example, and the minister wanting to require
information from companies, private clinics, walk-in clinics and hospitals, you
want that breadth. You want to capture all of those actors because they might
have relevant information.
The Chair: Thank you all very much. We have had the pleasure of two of
you before our committee on other occasions. Ms. Gibson, thank you so much for
being here. All three of you, on the basis of your testimony, have provided
tremendous clarity to the issues that you have identified. On behalf of the
committee, I thank you very much for appearing here today, and in doing so in
In this next session, we have two witnesses appearing by video conference:
Dr. Joel Lexchin, Professor, School of Health Policy and Management, York
University; and Dr. Stuart MacLeod, Professor, Department of Pediatrics,
University of British Columbia University of British Columbia. I will call you
in the order you are listed so that means we will hear from Professor Lexchin
first. Welcome back to the committee.
Dr. Joel Lexchin, Professor, School of Health Policy and Management, York
University, as an individual: I want to thank the Senate committee for the
opportunity to appear today by video conference all the way from Geneva,
Switzerland. As was mentioned, I teach health policy at York University and I
also work as an emergency physician at the University Health Network in Toronto.
I have been working on pharmaceutical policy issues for about 30 years and have
written many articles about the various topics.
My testimony will focus on two issues: First is the need to ensure that any
post-market studies are carried out in a timely manner; and second is the need
to improve on the amount of information that Health Canada discloses after it
has approved a new drug. I heard that the issue was talked about already by Mr.
Herder, Ms. Gibson and Mr. Attaran.
In discussing the first issue, I'll examine the situation regarding the
notice of compliance with conditions policy. For the second issue, I'll draw on
a study that my colleague, Roojin Habibi, and I recently published that looked
at the quantity and quality of information that is disclosed in the summary
basis of decision documents that Health Canada releases after it has approved a
The notice of compliance with conditions policy was initiated in 1998. The
goal was to provide patients suffering from serious life threatening or severely
debilitating diseases or conditions with early access to promising new drugs,
where surrogate markers suggested that these products offered effective
treatment, prevention or diagnosis of a disease or condition for which no drug
is presently marketed in Canada or if they significantly improved efficacy or
significantly diminished risk over existing therapies.
A surrogate marker is an intermediate step. For example, in the case of
cancer, a surrogate marker would not be that they would live longer but that the
tumour had shrunk in size. In return for getting this notice of compliance with
conditions, companies would then have to commit in writing to undertake
confirmatory studies to show that the initial promise of the drug was in fact
Since 1998, Health Canada has issued a total of 63 of these notices of
compliance with conditions for 46 separate products. If you look at the table at
the end of this short brief, you'll see that although 28 of these conditions
have been fulfilled, it took more than six years for four of them to be
fulfilled; and 27 have yet to be fulfilled. Some of those 27 have been on the
market for more than 10 years. We don't know why these studies haven't been
completed. Health Canada doesn't release any information about their status and,
as a result, people like me, when I am working in the emergency department, may
be prescribing these drugs without really knowing whether they work.
Second is the summary basis of the decision document. This is a project that
Health Canada started in 2004. The document is issued after a new drug or
medical device has been approved and explains the scientific and benefit-risk
information that was considered prior to approving the product. Of particular
interest to health care professionals is the section that contains a description
of the premarket clinical trials examined by Health Canada. Health Canada's
position behind releasing these documents is so that ``Canadian healthcare
professionals and patients will have more information at their disposal to
support informed treatment choices.''
As I said, I undertook an examination with a colleague of mine. We looked at
all 161 of these documents that were released between January 1, 2005, and April
30, 2012. In particular, we looked at information that health care professionals
would be interested in, such as information on the characteristics of patients
who had participated in the trials and the risks and benefits of the drugs.
For the characteristics of the patients, we looked at age, sex, whether the
patients were in hospital or outpatients, and how patients were chosen for
inclusion in the trial. For the risks and benefits of the drugs, we examined
information about how long the study ran, the statistical significance of the
results, whether the drug was compared to a placebo or another drug, what
percentage of patients withdrew from the trial, and whether there was any
difference between the percentage of patients who withdrew that were taking the
new study drug and those who withdrew that were taking the placebo or control
We were interested in information that a prescribing doctor would want to
know when faced with a patient. In other words, a doctor may ask the questions:
Does the patient resemble the patients who were in the study? Do I know enough
about the risks and benefits of this drug to be able to safely prescribe it for
my patient? Here are some of the results we found:
The number of documents that fully reported on the sex of the patient — 32
out of 161; the number that reported on the age — 53 out of 161; the number that
reported on how long the trial ran — 90 out of 161; the number that reported on
the number of people who withdrew from the trial — 4 out of 157; and the number
that reported on whether there was a statistically significant difference
between the numbers that withdrew who were on the new drug and the numbers who
withdrew that were on the placebo — 1 of 154.
Our conclusion overall was that clinical information in summary basis of
decision documents is presented in a haphazard manner with no apparent method to
its presentation. At least one third of the potential information about patient
characteristics and the benefits and risks of tested treatment is missing.
Based on what I have said, I have two recommendations with regard to this
legislation: First, if Health Canada requires post-market trials for drugs, then
it has to report on a regular basis, probably annually, on the status of those
trials. For example, Are they delayed? And, if so, why and when are they
expected to start? Are they in progress? When are they expected to be completed?
If they are complete, what were the results?
Second, Health Canada should ensure that all of the results of the clinical
trials dealing with the safety and efficacy of drugs are made publicly available
within a year of the completion of the trial after taking out any information
that may identify individual patients.
Thank you very much for your time; I'll be pleased to answer any questions.
The Chair: Thank you very much. I will now turn to Dr. MacLeod and ask
you to make your presentation.
Dr. Stuart MacLeod, Professor, Department of Pediatrics, University of
British Columbia, as an individual: I too am grateful for the opportunity to
be here. The matters that I'm going to comment on are quite divergent from what
Dr. Lexchin has been talking about but relate to my particular interests in Bill
I'm here as a professor of pediatrics at the University of British Columbia
and a long-standing member of the Paediatric Expert Advisory Committee for
Health Canada. My main research interests for more than 40 years have been in
drug safety and I see that as being still the primary focus of Bill C-17.
During the past two years, I've been the chair of a panel for the Council of
Canadian Academies and offer a shameless plug for our report, which was released
a week ago today, looking at means to improve therapeutic products for infants,
children and youth in Canada. I think that some of the issues addressed in our
report are actually part of what's intended with Bill C-17.
Between January 2013 and June 2014, I served as a special adviser to Health
Canada on the issue of developing an orphan drug framework and I further think
that some of the issues addressed in Bill C-17 are highly relevant to the
current efforts aimed at strengthening the Canadian process for studying
treatments for rare disorders.
Those are my interests.
My understanding of the key elements in Bill C-17 is as follows: I do
understand that where you stand depends on where you sit. You can read whatever
you want into the bill, but I see it as primarily intended to strengthen the
oversight of drug safety and improve the reporting of serious adverse drug
As you know, under Bill C-17, the sponsors of therapeutic products may be
ordered to conduct assessments and provide results based on studies that will
improve the information concerning a therapeutic product's effects on health and
safety. Studies that may be ordered under this legislation importantly include
monitoring of clinical experience. Although the bill's primary focus is on drug
safety, the minister is provided with some latitude, through Health Canada, to
order authorization holders for therapeutic products to conduct studies and
tests that begin to address some of the uncertainties about product efficacy. To
my mind, the study of safety and efficacy are really inseparable.
The new data secured under Bill C-17 will be extremely helpful in situations
where comprehensive clinical trials are not feasible from either an economic or
logistical perspective. The new information gathered will help to clarify where
we stand on the treatment of rare disorders or conditions that occur in small
populations within the pediatric or geriatric age range. I think if the bill is
successful it will help us to gain a better understanding of the genetic
determinants of drug safety and efficacy.
The authority to require monitoring of data from clinical experience will
give Health Canada some of the added scope that it requires to eventually
improve product information on safety and efficacy relevant to use in children,
the elderly and in rare disorders. This capability is very much in line with
previous recommendations that have come from this committee and addresses some
of the concerns raised by the CCA panel in its report, with this panel being
concerned primarily with gaps surrounding pediatric therapy and the need for
improved product labelling.
The legislation's provisions regarding data sharing and transparency require
much greater specificity to be introduced in the regulations regarding the
ministerial process for decision-making and should be designed to offer strong
assurance that disclosure will be limited to those who have valid scientific
interests in health protection and promotion. It will be helpful if a mechanism
of independent oversight is applied equally to all data holders in order to
maintain public trust in our national capacity for therapeutic evaluation.
While the sharing of data from completed clinical trials is an important
requirement for transparency, in my opinion there must be equal emphasis placed
on gaining new knowledge in areas where evidence is currently lacking in
pediatrics, geriatrics and rare disorders. In the end, acceptable progress
towards more evidence-based information on drug safety and efficacy will only be
made with greater investment in scientific infrastructure including the
fostering of active surveillance systems in Canada and increased encouragement
of innovative clinical trial methods.
The full benefits of Bill C-17 will not be achieved unless national efforts
are made sooner rather than later to foster training opportunities in evaluation
and implementation sciences relevant to drugs and devices.
In 2010, my colleagues at UBC and I completed a study for Health Canada that
showed a critical shortage of the necessary human resources outside of the
government regulatory agencies and industry in Canada. That's a deficiency that
must be addressed if Bill C-17 is to be successful.
The Chair: Thank you very much, Dr. MacLeod. I will open the floor for
questions from my colleagues, starting with Senator Seidman, the government
sponsor of the bill in the Senate.
Senator Seidman: Thank you both for your presentations. My questions
were going to focus on the after-market monitoring piece so I'm really pleased
to have heard your testimony today.
Dr. MacLeod, you spoke specifically to an issue that has been a high priority
in our two-year study and that has to do with subgroup populations that are not
generally involved in clinical trials — the pediatric, geriatric and rare
disorder groups. The fact that we now have new authorities for the minister to
deal with the life cycle approach is something that we all understand is
important to the health and safety of Canadians. But giving her these
authorities for post-market surveillance, the monitoring of drugs once they're
on the market, my question is: Should pharmaceutical companies be responsible
for conducting this kind of monitoring after a drug is on the market? Or, is
there a need for a more independent approach to evaluating the safety and
effectiveness of a drug once it's on the market?
Dr. MacLeod: I would suggest a bit of both. I think it would be
unrealistic to rely in all cases on the pharmaceutical industry to monitor the
use of its products, particularly in the situations I alluded to when we're
talking about small populations — perhaps people with rare disorders, young
children — where drugs may be used outside their normal labelling or in fact
breaking new therapeutic ground entirely.
In those situations, I think it's up to the researchers who are doing the
studies to make sure there is long-term evaluation of safety and long-term
follow-up on the drug effects.
So I don't think there is one solution that will fit every situation.
However, most of us who do research on drug safety would agree absolutely that
the long-term monitoring should be done, and we shouldn't lose the data that's
available from clinical experience in the real world.
Dr. Lexchin: I would like to see more independent study after drugs
are on the market. There are a number of examples from the United States that
have been disclosed through lawsuits launched against companies where companies
have hidden data. One particular example that comes to mind is studies around
antidepressants for use in adolescents and teenagers. The studies that were done
that were unsuccessful were not published and were kept in a file drawer
If we are going to conduct more independent studies, there has to be more
money going into them. So a large-scale study — and I'm thinking here of the one
that was done on hormone replacement therapy funded by the NIH. It was a
10-year-long study. I think that ran to $100 million, and that's just for one
So if we're serious about independent monitoring, we have to be serious about
Senator Seidman: Could I ask for a clarification? To what extent is it
your understanding that pharmaceutical companies monitor the post-market aspects
of their drugs?
Dr. MacLeod: It depends a bit on your definition of the word
``monitor.'' Companies are required under current law to track all adverse
reactions that are reported to them. There is a big difference between that and
some form of active surveillance or planned protocol study — the sort of thing
Dr. Lexchin is referring to — which can be enormously expensive, if you're
talking about a therapy that's going to be widely used. It's not necessarily so
expensive if you're talking about a rare disorder where there may be 100 people
in the world who are being treated.
Does that answer your question?
Senator Seidman: Yes, it does.
Senator Eggleton: I'm going to ask the same question I asked the
members of the last panel because it's certainly one of the things that has
concerned me and this committee in its study on pharmaceuticals; that is, the
question of transparency, going back to the clinical trial process and the
registration process, which we recommended in our first report, but also
complete through the life cycle of inspections and what is done further by
Health Canada as the regulator — the disclosure of this information so that it
can be of value to the practitioners, the public and community to help lead to
This particular bill has a lot of instances of the word ``may'' in it, and
there are some provisions that were added by the health committee in the House
of Commons that use words like ``ensure'' and ``shall.'' I want to get the
maximum reasonable process for disclosure here and the law and regulations that
will help lead to that.
Just by way of further comment on that, Dr. Lexchin, you in your presentation
have talked about a couple of areas where the information flow or the follow-up
flow falls down: the notice of compliance conditions; the years you pointed out
it takes; and the summary basis of decision, which supposedly was providing more
information — but there is a lot of, as you call it, ``haphazard manner'' — a
lot of holes in that amount of information that is being provided.
Should we be tightening up Bill C-17 to make it more compulsory, with more
``shalls'' and ``ensures'' as opposed to ``mays,'' which may leave discretion in
the hands of the minister, which could result in exemptions being put in place?
I'd appreciate your comments on this question of transparency, specifically
how it comes out of Bill C-17.
Dr. Lexchin: Yes, I do think that we need a lot more transparency
written into Bill C-17 than is currently there. Specifically, we need the
transparency around the safety and efficacy data that's generated through either
clinical trials or, after the drug is on the market, through observational
studies. That should be the default position. Then if there is information
that's going to be withheld, there could be exemptions written in for particular
But as it is, that release of information is not, in my reading of Bill C-17,
the default position — that everything is made public, subject to redaction of
information, for instance, that would identify individual patients.
Unfortunately, over the years, there are many examples where Health Canada
has simply refused to release information because the company that owns it has
refused permission. For instance, a number of years ago I applied for the
information on clinical trials that Health Canada used to approve a number of
drugs used in the treatment of diarrhea in children. I awaited 21 months. One
document, based on the index, had 298 pages. I received four pages, and the most
information I got were the headings on a table; all the data in the table had
been removed because the company would not agree to release it.
Dr. MacLeod: Yes, I agree with Dr. Lexchin's comment, but I think
there are two sides to the question. There is a question of transparency around
data that is already in the hands of Health Canada — that has been submitted as
part of an application for the market authorization. The assurance that that
data will be shared more widely does require discussion.
But there is also a huge body of data that comes from post-marketing sources.
The data holders in this field are not by any means entirely in the
pharmaceutical industry. For instance, at my hospital, BC Children's Hospital,
half of the clinical trials done in any given year are sponsored by individuals
— sponsored by the researchers themselves or their departments. So they have a
huge source of valuable data that Health Canada would, in most cases, never be
aware of. It's a real dilemma how best to bring about transparency of that large
One of the things I find encouraging in Bill C-17 is that it specifically
mentions experiential monitoring. It allows the minister to get beyond what can
be achievable under randomized double-blind controlled trials, which are
important, but they're only part of the package.
I think it's clear that we have always learned more about drug safety through
post-marketing surveillance. Many of those trials are investigator-sponsored;
some of them are industry-sponsored, but that's not the norm; and some of them
are large-scale epidemiological studies undertaken with the support of research
agencies. We need to find a better way of bringing all this together.
I think I heard the previous presenters say that they thought Bill C-17 is a
good first step but really doesn't go far enough and I agree with that entirely.
Senator Eggleton: I want to pick up on something you said, Dr.
MacLeod, and this is for comment from either of you. On adverse drug reactions
in the post-approval process, this bill talks about prescribed health care
institutions. This would be a means of getting better data, presumably, on
adverse drug reactions. What would you see covered by this definition? How broad
or narrow should it be? It's not defined in the bill but will be in the
regulations. Most people think it means hospitals. It probably does, but what
about beyond that?
Dr. MacLeod: I think it needs to go beyond. Hospitals, as long as I've
been around, have been under an obligation as part of their accreditation
standards to report on their adverse reaction rates. The reports that they make
are not very useful because they're completely voluntary and, to use Dr.
Lexchin's word, haphazard. Some institutions are undoubtedly better than others
in reporting them, but in any case it's a very incomplete record.
I think we need to be a lot more specific in the regulations about what sort
of information is to be gathered and by whom. Some of the best studies will come
from zealous clinicians who really just notice something going amiss with their
patients and follow up or maybe initiate a multicentre study of that on their
Dr. Lexchin: It is to give Health Canada more resources to do the
monitoring and to encourage the monitoring. Right now, for instance, if I, or
anybody else for that matter, were to report an adverse drug reaction to Health
Canada, at best I would get a form letter saying thank you very much. I would
get no feedback from Health Canada as to whether this had been reported before.
I would not get any feedback as to what they were doing with the data that I
sent them. In contrast, in New Zealand when somebody reports an adverse
reaction, they get an individualized letter back telling them what will happen
with the information and what has already been reported about the drug.
Some of this may be because of the relative lack of resources that go into
the Marketed Health Products Directorate at Health Canada. The last figures that
I have seen show that if you add up the number of people and the amount of money
that goes into the two directorates that approve or review new drug
applications, it's about three and a half times more than the money and people
are made available to the Marketed Health Products Directorate. I definitely
think we need better monitoring. One of the ways, certainly not the only way, to
do that is to give Health Canada the resources to be able to do it.
Dr. MacLeod: Part of the problem is that our entire system in Canada,
as long as I've been a clinical pharmacologist, has been based on passive
surveillance — voluntary reporting. There's ample evidence that the only way you
get to the bottom of adverse drug reactions is through active surveillance and
perhaps in targeted conditions.
Senator Eggleton: The final question I will ask is to Dr. MacLeod. You
mentioned, and I didn't quite catch the context, training and expansion of human
resources. What did you have in mind?
Dr. MacLeod: The science of studying adverse drug reactions is
complex. You need a whole retinue of epidemiologists, clinician scientists,
pharmacists in the case of drugs, experts in pharmaceutical sciences and
formulations, and so forth. We undertook a survey for Health Canada when they
were presenting Bill C-51 and we were interested in whether we had the human
resource base in the country to carry out Bill C-51 if it was approved. We were
able to find only 350 individuals in the country who had at least some of the
qualifications to carry out drug evaluation studies. For example, not all of
them were experts in adverse drug reactions and probably only about half of them
were truly acceptable as experts in the eyes of Health Canada.
There was a relatively small number and, of course, all those people were
gainfully employed doing their own research. There's no certainty that they
would jump into the fray and take on an industry-sponsored study or even a
government-sponsored study addressing a suspected particular putative adverse
Senator Eggleton: Who needs to take the leadership role in further
development of that?
Dr. MacLeod: As Dr. Lexchin has been saying, if we're really serious
about drug safety and about drug efficacy and studying it better, then we need
more resources. Health Canada needs more resources and the Canadian Institutes
of Health Research need a targeted plan in this area.
Senator Enverga: My question is for Dr. Lexchin. In your presentation
you pointed out that that the process for Health Canada's notice of compliance
with conditions is long and drugs keep being prescribed while the process takes
place. In your opinion, is it the current legal framework that causes this
backlog or are there internal issues in Health Canada that cause this delay? If
it is a legislative issue, does Bill C-17 address it?
Dr. Lexchin: As to what causes the delay in the studies that the drug
companies are obligated to undertake, the answer is that we just don't know.
There could be a variety of things. They could just be not interested. They
could be having trouble recruiting patients for them. There could be unforeseen
circumstances that come up around the conduct of the trial. There could be
delays in analyzing the data. All of that is a big black hole. We just don't
know why these trials sometimes take so long. Health Canada may know, but Health
Canada is not telling us.
The second part of your question was whether Bill C-17 addresses this?
Senator Enverga: Yes.
Dr. Lexchin: Not specifically. It certainly gives the minister the
power to order post-market studies, but it doesn't say anything about disclosing
the conduct of those studies and what's going on with them; so I think that
needs to be written into Bill C-17.
Senator Enverga: Do you have any answer to that?
Dr. MacLeod: The issue you're raising is really external to the
concerns of Bill C-17. It would be a place that could be addressed, but my
advice would be to leave that for another day. I would just say that the idea of
notice of compliance with conditions came to the fore when HIV/AIDS became a
major concern and many patients across the country were demanding new drugs that
had not been adequately tested yet in the gold standard of randomized controlled
clinical trials. I could impute to Health Canada a desire to meet their demands
for timely therapy while continuing to gather evidence. It's a complicated
issue, and I would leave it out of Bill C-17.
Senator Enverga: Dr. MacLeod, the committee heard testimony that the
off-label use of drugs is common. Some are concerned about the adverse effects
of such use. For a researcher into child and family medicine, is there an
alternative to off-label use when it comes to certain groups that are not
usually part of clinical trials, such as children and pregnant women?
The Chair: Can I ask you to focus that with regard to Bill C-17? We've
written an entire report on this issue. We're studying Bill C-17, so the answer
has to relate to Bill C-17.
Dr. MacLeod: I think Bill C-17 is, again, a step in the right
direction. It does allow the minister to mandate studies in areas where there
appears to be an important health issue. It may be extremely difficult. There
may be only a very small number of patients who will be entered into a study,
but there is a requirement for reporting back to Health Canada, and at least
some evidence will be added to the evidence that's available to support optimal
decision making about therapy. I think Bill C-17 is a beginning to mandating
labelling in situations where it looks like it's important.
Senator Enverga: Dr. Lexchin, do you have any reply to that?
Dr. Lexchin: The only thing I would add to what Dr. MacLeod had to say
is that in order for the minister to be able to order studies into the risks and
benefits of off-label use is that they need the data to know that is going on,
and right now, aside from some specific circumstances — I'm thinking of the
program that Dr. Tamblyn runs in Montreal at McGill — you can't get that data.
So yes, the power in Bill C-17 to order post-market studies should certainly be
applied in off-label use, but then you need to know how much a drug is being
used off-label and in what particular populations.
Senator Chaput: Both of our witnesses today have talked about Health
Canada needing more resources, and that has been said also by a previous witness
at this committee. Now, taking into consideration that it's not always possible
to get more resources or funding, could or should Health Canada do things
differently? Could they have different targets according to what Bill C-17 is
asking? Could they change their focus and use their resources in a different
way? Do you think it would be possible?
Dr. MacLeod: In my opinion, they need more resources, new resources.
Some of these resources will be directed to something like the Canadian
Institutes of Health Research or to the Drug Safety and Effectiveness Network,
which is designed to deal with many of these issues. So they are both funded but
not adequately funded to take on new tasks or expanded tasks as are described in
Dr. Lexchin: I would agree with Dr. MacLeod that I would not want to
see Health Canada, in effect, rearranging the deck chairs on the Titanic.
You need a bigger boat.
Senator Chaput: Fair enough. Thank you.
The Chair: Before I make any comments, I want to go to the sponsor,
Senator Seidman, and to Senator Eggleton for a final question.
Senator Seidman: I did want to deal with the resource issue in one
particular way. When we did our prescription drug study, I think we were quite
horrified when we looked at adverse effect reporting to discover that it was
mostly done manually, so in fact, over 70 per cent of adverse reaction reports
were paper-based and had to be entered manually. You can understand, by the time
they entered each one manually, got into the database, it took quite some time
for signal detection and to get anything back to those who were producing the
signals. In other words, Dr. Lexchin, as you send in an adverse reaction, you
want to get some feedback. You can imagine when you have paper entry how complex
and time-consuming this would be.
In fact, I think what we should note in terms of the resource issue is that
Health Canada has now adopted, as we discovered, an e-reporting system which
will facilitate and speed up the process, and hopefully as a result you will get
that response that you're requesting much more quickly, easily and with much
more detail. At least that's what we hope. The whole e-system and certainly this
e-reporting for adverse drug reactions does produce a lot more hope in giving
you what you want and giving Canadians what they want, of course, in terms of
health and safety for them.
Dr. Lexchin: The only comment I would have is, again, to agree with
Dr. MacLeod. Passive reporting is useful; that's often how we pick up signals,
but it's certainly not enough and we need to move to active monitoring once
drugs are on the market, and to the extent that Bill C-17 does that, it's a good
Dr. MacLeod: I agree entirely. My colleagues in British Columbia have
some experience with active surveillance. We have an entity called the Canadian
Pharmacogenomics Network for Drug Safety that's looking for genetically
predetermined adverse drug reactions, but we have active surveillance in all
children's hospitals across the country and all the pediatric oncology centres,
and we get much better data on drug safety than will ever be obtained through a
passive system, and it is less expensive.
Senator Eggleton: In the presentations we've had about the recall
provision in Bill C-17, a couple of people have suggested that there needs to be
a graduated or an interim step, a suspension. There is a provision in the Food
and Drugs Act for suspension, but it's not clear how that would relate to this
The two witnesses used words like going directly to a recall as being a
nuclear option, or another one said it was a sledgehammer approach and there
needed to be something in between, such as a suspension, because it may be that
there are still some unanswered questions and it may be more severe to be
instantly going to a recall than to doing that. I would like your thoughts on
Dr. MacLeod: I think the notion of a graded response is the correct
one. There will be situations where it's absolutely black and white, where you
know as soon as it's reported that you're dealing with an issue that's of such
importance that the drug has to be taken off the market. On the other hand,
there may be situations that have something to do with an aberrant formulation
or some data that's equivocal that requires further study, and in that
situation, you absolutely don't wish to deprive the patients who are currently
benefiting from the therapy of the treatment that they're relying on.
I would say it's all about relative safety and relative efficacy and striking
a balance, but situations where it's absolute will be few and far between.
Dr. Lexchin: I'll take the point of view of the regulator, which is
that if the only sanction you have is what Senator Eggleton called the nuclear
bomb, you're not going to use it. So you get into these situations where there
are doubts, there are grey areas and the two options are either leave the drug
on the market, or pull it or recall it completely, and the regulator is not
going to take that approach. A pyramid of escalating sanctions or options is
certainly something that has been advocated in a number of regulatory
situations, not just when it comes to drugs, but to other things. So the first
time you get a slap on the wrist. The second time you get called into the
principal's office. And the third time you get suspended from school.
The Chair: I think we need to enter into this discussion that Bill
C-17 is not the entire volume with regard to the regulation of drugs, and that
the existing regulations that have not been changed by this bill remain in
effect, which include suspension and a number of options to the minister.
I'm not trying to suggest for a moment I'm disagreeing with your arguments on
a range of issues, but we must not leave the impression that there are not
already in the regulations and not overruled by this bill a series of options
available to the minister to deal with a number of these issues. What is here
now is a much higher level of activity that is added to the minister's ability
with regard to the regulation of drugs.
I wanted to come back to one of the issues that both of you have referred to
today, and that is essentially the post- market surveillance of drugs. I am sure
both of you know we have been recommending very strenuously in this area,
including the concept of a life-cycle approach to drugs — where we put it most
recently — in that context, and recommending as many resources be applied to
post-approval monitoring as in the actual approval stage.
I think it was you, Dr. MacLeod, who referred to the minister having certain
avenues available to him through existing organizations to look into some of the
issues. And DSEN, which you didn't mention in this context but you mentioned
that you had been involved with, is one we have recommended as an organization
to be given authority and resources to deal and have the ability on its own to
look at issues in drugs that are in the market.
Do you see DSEN as having an increasingly valuable opportunity to advise the
minister through this new bill?
Dr. MacLeod: DSEN is a very valuable enterprise, and it has done very
well in its first five years. In order to meet all the concerns around drug
safety and drug effectiveness going forward, it would need more resources. But
it does meet the condition of being pan-Canadian and of being relatively
independent, in spite of its origins. It would probably be better if it was a
little more at arm's length from Health Canada.
We're dealing with public mistrust of the system. My friends are all involved
with DSEN, so I'm not being critical of them, but DSEN is part of CIHR and is
part of a provincial-federal response. I'm not sure that all the solutions we
need here lie with government.
The Chair: You'll find our recommendations in that regard of interest,
as well. Dr. Lexchin, do you have a final comment on this?
Dr. Lexchin: Not really. Again, I would have to agree with what Dr.
MacLeod is saying. DSEN is very useful. At $10 million a year, we're getting
good value for our money, but more money could go into it. Going into the
future, we need to look at more ways of generating the data that we're going to
DSEN is one option. We could look at, for instance, what the U.S. is planning
on doing with their Sentinel Initiative, whereby they're going to be able to
draw on privately held or non-governmental databases. We could look at a project
that I'm involved with, which is getting doctors in British Columbia to enter
into the PharmaNet database adverse drug reactions that are detected in
emergency departments. There is a field for that. So there are a variety of
additional options that could be explored.
The Chair: Thank you very much. To both of you, on behalf of the
committee, thank you for your exceptionally fine testimony before us today, the
clarity of the answers that you have provided and the additional insights into
the issues faced in monitoring pharmaceuticals and ensuring the health of
On that note, I want to thank my colleagues as well for the meeting today.