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 Act.

Senator Kelvin Kenneth Ogilvie (Chair) in the chair.

[Translation]

The Chair: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.

[English]

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 committee.

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?

[Translation]

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.

[English]

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 forth.

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 definition.

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 we seek.

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 incorporate this.

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 explicit.

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 accomplish this.

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 high standard.

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 health.

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 systematically buried.

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 your consideration.

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 Eggleton.

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 of injury?

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 risk.

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 regulations?

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 pushing for.

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 States.

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 ``may''?

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 graduated levels.

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 other question.

The Chair: Are you sure? I was just trying to get to your next question.

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 operate.

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 products?

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 jurisdiction.

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 bill.

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 decades.

Senator Enverga: It's a good change?

Mr. Herder: If you improve the wording.

The Chair: He answered that part.

[Translation]

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?

[English]

Ms. Gibson: I don't know the answer to that.

[Translation]

Senator Chaput: Fine, thank you. And what are your thoughts, Mr. Attaran?

Mr. Attaran: Can you explain to me what type of legal action you are referring to?

Senator Chaput: I was referring to cases where drug manufacturers could take a department to court when they are stopped from selling certain medications.

Mr. Attaran: Yes, that sometimes happens here. Apotex, for instance, had a few problems with the department two or three years ago.

[English]

Apotex sued the minister over a recall they disagreed with.

[Translation]

Senator Chaput: Are there legal provisions in other countries that protect departments against this type of prosecution?

[English]

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 doesn't.

[Translation]

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 —

[English]

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 that fashion.

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 new drug.

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 being realized.

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 drug.

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 C-17.

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 reactions.

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 somewhere.

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 study.

So if we're serious about independent monitoring, we have to be serious about money.

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 greater safety.

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 circumstances.

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 experiential database.

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 own.

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 reaction.

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 Bill C-17.

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 first step.

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 recall provision.

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 that.

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 need.

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 Canadians.

On that note, I want to thank my colleagues as well for the meeting today.

(The committee adjourned.)