Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology

Issue 19 - Evidence - September 24, 2014


OTTAWA, Wednesday, September 24, 2014

The Standing Senate Committee on Social Affairs, Science and Technology met this day, at 4:15 p.m., to consider 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]

My name is Kelvin Ogilvie from Nova Scotia, chair of the committee, and I'd like to start by asking my colleagues to introduce themselves, starting on my left.

Senator Eggleton: Art Eggleton, senator from Toronto.

Senator Chaput: Maria Chaput, senator from Manitoba.

Senator Enverga: Tobias Enverga, Ontario.

Senator Seth: Asha Seth from Toronto.

Senator Stewart Olsen: Carolyn Stewart Olsen, New Brunswick.

Senator Seidman: Judith Seidman from Montreal, Quebec.

The Chair: Just before we get into the agenda and welcome our witness, there are a couple of things that I need to do.

First of all, we are here today to study Bill C-17, an Act to amend the Food and Drugs Act. The short title is: Protecting Canadians from Unsafe Drugs Act, or Vanessa's Law.

I have a piece of information that I need to inform the committee of as a matter of the record of committees of the Senate. You should be advised that I received today a written declaration of private interest made by the Honourable Senator Pana Merchant in relation to the committee's consideration of Bill C-17, An Act to amend the Food and Drugs Act. The declaration of private interest will be recorded in the minutes of the meeting, and so she recuses herself from these hearings.

I am very pleased to welcome, as the very first witness for our study of this bill, Terence Young, who is a Member of Parliament for Oakville and founder of Drug Safety Canada and, in this regard, the inspiration and the sponsor of this bill in the House of Commons.

Terry, we welcome you, and I'm also very pleased to acknowledge that your wife, Gloria, is in the audience for this important event today for everyone. I formally call you Mr. Young, but, Terry, with that I would invite you to make a presentation to the committee, which will be followed by questioning. I remind our committee that this part of our agenda will end no later than 5 p.m.

Terence Young, Member of Parliament for Oakville and founder of Drug Safety Canada: Thank you very much, chair, and thank you to the committee for inviting me here today during your examination of Bill C-17, Vanessa's Law. It's been a great experience to be in Parliament on the cusp of a generational change in patient safety, and I think it reflects very well on Parliament and our democracy that the preventable death of an innocent 15-year-old girl could lead to such profound changes to the federal regulatory regime in a non-partisan way, assuming the bill goes through the Senate. There are few countries in the world, I think, that could make that claim.

It is not common that such a comprehensive government bill passes unanimously through the other place, and I am hopeful it can do so in the Senate as well.

I am very supportive of the bill as written and convinced that the legal counsel that drafted the bill not only fully grasp the issues and intent but have also carefully and rigorously examined every word and term with respect to its meaning in the context of legal practice and in the context of similar acts.

Vanessa's Law addresses the major issues within federal jurisdiction, providing a very sound structure for the regulations that will fulfill its purposes.

Key elements of the powers for drug management in Vanessa's Law are your recommendations, including power to order post-approval studies, to require label changes, to require reassessment of safety and efficacy, to disclose publicly information about a drug's risk and benefits and to recall drugs. As for the power to require patient information leaflets and registering clinical trials, registered clinical trials was also your recommendation, and patient information leaflet powers are in the existing Food and Drugs Act.

Preventable adverse drug reactions kill patients every day across Canada. I'm sometimes haunted by the thought that other children will, like soldiers just minutes before an armistice, die from a drug reaction weeks or even days before the changes contained herein can be implemented.

In fact, Vanessa died March 19, 2000, within days of the fifth and only effective warning sent out to doctors by Health Canada. This is just to say that the sooner Bill C-17 becomes law, the better.

In July 2012, GlaxoSmithKline paid the largest fine in U.S. history, $3 billion, to settle charges for illegally marketing and failing to report safety risks for three of their blockbuster drugs — Paxil, Avandia and Wellbutrin. Hundreds of innocent victims died after taking these drugs. However, no one went to jail, and the $3 billion fine amounted to only 10.8 per cent of their revenues for these three drugs, a simple cost of doing business.

The British Medical Journal recently reported that all civil and criminal penalties paid to the U.S. federal and state governments by big pharma companies, from January 1991 through July 18, 2012, totalled $30.2 billion. The companies are a who's who of big pharma: Novartis, Pfizer, Abbott Labs, Eli Lilly, TAP, Amgen, Serono, Merck, Purdue, Allergan, AstraZeneca, Bristol-Myers Squibb, Cephalon, Schering-Plough, Wyeth, Johnson & Johnson, Ortho-McNeil and more. Dr. Sidney Wolfe, from Public Citizen, concludes: ``. . . there is a pathological lack of corporate integrity in many drug companies.''

Here is GlaxoSmithKline's promise on integrity on their Canadian website: ``We'll ensure that doing what is right for our patients and consumers is at the heart of every decision we make. . . .'' Yet, just last Friday, GlaxoSmithKline PLC was fined a record $535 million by the Chinese government for bribing doctors to prescribe its drugs, a practice that replaces the patient at the heart of every decision with cold hard cash.

Mark Reilly, the former head of GlaxoSmithKline in China, was sentenced to prison but is apparently home in England again.

GlaxoSmithKline CEO, Andrew Witty, said in an official statement: ``We have and will continue to learn from this.''

This is the current state of ethics worldwide in the pharmaceutical industry. No group that claims to put patients first is doing so.

It is joyful for me to say that the sanctions in Vanessa's Law are strong enough to deter the above corrupt practices and to create a generational change for Canadian patients.

In closing, I note my introductory remarks that industry representatives have testified on the record in the other place they are in support of Vanessa's Law. Yet, I've heard they are already trying to undermine the bill before it even becomes law by asking to eliminate actions by Health Canada on a drug unless the risks to patients are imminent. That would keep dangerous drugs on the market longer.

In 2003, I helped get Serzone off the market, which causes liver damage over weeks and months. Health Canada could expect arguing from the drug companies that there's no adverse imminent effect with such drugs because it takes place over time. They could also argue that suicides — like Sara Carlin's caused by Paxil or Brennan McCartney's caused by Cipralex — were not imminent because only one out of 50 young people suffer akathesia and they all don't kill themselves, so that's not imminent. They might also argue that rare adverse drug reactions, like heart attack and stroke suffered by the users of Vioxx, were not imminent because they were not proven by cause and effect.

Senators, I say for the record that this transparent attempt to undermine the bill is a product of the same pathological lack of integrity big pharma has displayed time and time again. They just can't help themselves. Vanessa's Law is the solution. Please pass this bill with dispatch. Thank you for your critical role in creating it.

The Chair: Thank you very much, and I'm now going to open up the floor to questions. Senator Seidman is the sponsor of the bill in the Senate and Senator Eggleton has kindly deferred, as deputy chair, his first question to her. I will turn to Senator Seidman first.

Senator Seidman: Thank you very much, Mr. Young. There is no question that this bill has been a long time in coming, 50 years, in fact, since there have been any changes in the Food and Drugs Act. That's a long time. This bill, which has been received, as you say, very well by everyone makes very important changes that concern the health and safety of Canadians.

I'm sure you know that this committee has just completed a two-year study on prescription pharmaceuticals in Canada, and we heard much about very serious issues that have to do with drug development, monitoring gaps, unintended consequences and oversight problems. I think it's clear that this bill is going to address important aspects and help us to better protect the population. But specifically, and perhaps you might speak to this, we heard a lot about population subgroups, children and seniors who are not included in clinical trials, generally. There's no question that there's concern for the effect of prescription pharmaceuticals when they use them, and so I'd like to know how you see your bill helping specifically in that respect.

Mr. Young: The subpopulations?

Senator Seidman: Yes.

Mr. Young: Well, there are a couple of ways. The first way, and I think it's very powerful, is that the bill will empower the minister to require registration of all clinical trials. This means that instead of conducting a series of clinical trials that might show a drug is not working, only working slightly or is harming patients — and then burying them so they can never be found again — the law will require them to be registered and the data published, even if the trial is not completed. This is very important because the trick now, if the trial is going badly, is to stop it and tell the researcher they have to sign a gag order that they'll never talk about it again.

So transparency with this is huge. Anything that becomes evident through trials, any kind of evidence, researchers will be able to find all the studies and make a clear statement.

But the bill also gives the minister the power to provide information to request information on subpopulations. So if the minister finds that, in fact, the pharmaceutical company or doctors on their own are using a drug off-label and it may be harming a subpopulation, for example, children, she or he can ask them to conduct further studies and provide that information to the ministry in short order.

Senator Seidman: Okay, that certainly demonstrates there are protections built in for groups who are constantly at risk because they're not included in clinical trials, generally.

Mr. Young: She could also order them to compile any information on any use they have in subpopulations that the drug may not have been tested on, for example on pregnant women, the elderly or children.

Senator Seidman: Okay, thank you very much, I appreciate that.

The Chair: Okay. We'll now turn to Senator Eggleton, deputy chair of the committee and the critic for the bill in the Senate.

Senator Eggleton: I prefer to say the spokesperson for the opposition.

I am not a critic of the bill in the sense that I think the bill is a good start. To me, the question is: Should it be going a little further? Are there improvements we should be making to it at this point in time?

However, I first of all thank you for being here. Your passion over the years — and quite understandably so because of the loss of your daughter — has really inspired all of this, and that's a good thing.

I think this committee has a lot in common with the concerns you've expressed over that time, in terms of the work we've done on our pharmaceutical studies and many of the recommendations. We like to think we're instructive in creating this bill along the way.

One of the issues you mentioned is the question of registration, and this relates to the transparency aspect. Certainly people that have come before us, in the medical profession and others, said they need to have the information to better know what they need to do to help ensure public safety. We want Health Canada to step up its efforts to ensure public safety as well, and that's all part and parcel of more openness and transparency, starting with this registration system.

But much of this bill uses the word ``may.'' The minister may do this or the minister may do that. I hear what you're saying and in the Senate a week ago, Senator Seidman talked about what the intent is. But that intent is, by and large, coming through regulations as opposed to being here in the bill itself.

So how do we ensure that the regulations will meet this test? I think part of the test, by the way, should be that we have no less of an open and transparent system than what the Europeans have, the European agency, what the FDA has in the United States, or what they're planning. They're actually planning some amendments themselves.

That's the bar that I am looking at. How can we be sure, through monitoring the regulations, we actually meet that high bar?

Mr. Young: I could take a stab at answering this question and I could give you my opinion, senator. I've stated already: I am very clear that the people who have written this bill at Health Canada, the people who will be working on the regulations after, get it. They understand the intent, they understand the needs that we're trying to meet and they understand the risks of Canadian patients.

When I saw the amendments that I was able to present in committee that added a whole clinical trial transparency piece to this bill, I have to tell you, I was thrilled. I didn't know they had them ready, but I know one individual in Health Canada has been working on this bill for 14 years. I'm convinced they will do it right and they'll get the regulations right. But the devil is in the details, and so you look at the intent and the competency of the people. I wanted to ask the chair, and perhaps this is a time that would be appropriate, David Lee is here from Health Canada who has helped to write the bill —

Senator Eggleton: I talked with him earlier.

Mr. Young: Would it be helpful and appropriate to bring him forward beside me?

The Chair: He will be appearing with officials at the end, and I think he was very kind and gave a detailed explanation that Senator Eggleton heard earlier with regard to this. So unless Senator Eggleton feels that it is essential at this time, normally we would wait, in the fullness of the hearings, to have him appear and respond to the question.

Senator Eggleton: I had a good conversation with David Lee earlier today. Both the chair and I were there. But we also have a history — you've had one too — with Health Canada, and it has not always been the best. We haven't always been impressed by their work. We've seen criticisms from the Auditor General about the number of inspections they do or how long they take to report on things that could mean people are at risk during that period of time.

I think there's a need to gain confidence that we believe that organization will step up its game in this regard, and so it was in that spirit that I asked you that question, but when we get to the Health Canada people later in this series of meetings, I will address that.

Mr. Young: Senator, perhaps I could give you a brief answer.

Senator Eggleton: Sure.

Mr. Young: As I have done thus far, as a parliamentarian, I intend to watch this process like a hawk.

Senator Eggleton: I'm sure you will. That's good. I'm glad you're there to do that.

Let me ask you one other question with respect to the criticisms of the Auditor General, to go back to that for a moment, about the fact that Health Canada has not met their inspection quotas, et cetera, they also had some budget cuts a couple of years ago. They had some 275 positions removed, I believe, in the division that was responsible for monitoring all of these things. If they were struggling at that point in time to be able to do their work, how are they possibly going to do their work with this additional load that Bill C-17 brings to them?

Mr. Young: That's an interesting question, senator, and I'm unfamiliar with those numbers. I haven't heard those numbers before, but I think there's an assumption that when you pass a bill it creates more work. The opposite might be true in this case I have copies of communications between Janssen Ortho after Vanessa died when the senior person, Marta Caris at Health Canada, was trying to get them to take Prepulsid off the market, and the correspondence is this thick, back and forth. You can tell they spent hours on every letter on both sides, and this went on for months. That's extremely time-consuming for a civil servant.

Whereas when you have the power, you send one letter or you make one phone call. You sit down and say, ``This is what we want you to do,'' so it doesn't take months. I'm thinking it's quite possible that providing these powers to experts at Health Canada and the minister could actually take less time.

Senator Eggleton: Yeah, I think that should be the case. I would agree with you. But you know, on this recall position, the minister has not exactly been without ability to handle these things. I mean, yes, technically, currently, the minister would have to negotiate, but the minister does have some other powers. Suspension of an operating licence, for example, is pretty powerful. There are things that a minister could do that are powerful, but they haven't been done.

Mr. Young: Regarding the suspension of a licence, my understanding is if a minister withdraws the Notice of Compliance, it would apply to all the drugs at that company selling on the market. That's what I've been advised. That would be the nuclear option because there are people that are using those drugs daily, and it's providing relief or killing pain for them, et cetera, so that would be worse than a blunt instrument.

But with Vanessa's law, the minister can make a ruling with regard to a specific drug in a timely fashion.

Senator Eggleton: Good answer. Thank you very much. I'm sure you'll monitor the budget thing as well. I'm sure they've got the resources.

Mr. Young: You can be reassured of that.

The Chair: Thank you. I will now turn to Senator Seth to be followed by Senator Enverga.

Senator Seth: Thank you, chair, and thank you, Mr. Young, for your illustration. I know you have been working on this issue for a long time, and I would do the same if I was in your place. I know most of the things you have answered just now.

Do you think Bill C-17 provides the minister the power to issue a recall? Do you agree with that?

Mr. Young: That the minister should have this power?

Senator Seth: Yes, the new ministerial power.

Mr. Young: Absolutely.

Senator Seth: Do you think there is any better person who can handle this responsibility who is not politically involved? Do you think that would be a better idea?

Mr. Young: I don't know any minister who would do that without a clear recommendation from the senior staff at Health Canada, the regulators who have all the information, because it's a very serious thing to do, and it can be a challenge. It's something that has to be done and should be done earlier, for instance, the drug Vioxx, which was taken off the market voluntarily, and this is what the pharmaceutical companies say. They always say they took it off the market voluntarily because if they do that, for instance, in the United States, then the other hundred countries they are selling the drug in might not notice, and then they can keep it on the market in all these other countries, et cetera.

This allows the minister to make a decision to protect Canadians, and then if they want to conduct a review or find a way the drug can be prescribed safely, they can present that information to the minister and try to have the drug put back on the market in limited capacity, special status or special access.

Senator Seth: Can you explain how the minister will have the power? How quickly will the recall process happen?

Mr. Young: It's only ever happened once at Health Canada that I'm aware of that they actually pulled a Notice of Compliance. It was a drug called Adderall which was addictive for young people. It's actually speed. They use it like Ritalin to help young people focus in school, et cetera, and they withdrew the NOC temporarily, and then they beefed up the warnings and allowed them to begin selling it again under a great deal of pressure.

I don't think they've used the power before, but the most famous case, and I'm trying to think if it was ordered off or came off voluntarily, was thalidomide in the 1960s where in the U.S. a woman, who later received an award from President Kennedy, refused to approve thalidomide for the U.S. market and saved Americans from having the issues of having infants born with flippers and dying, et cetera.

So I'm sure it's something a minister would only do after great consideration.

Senator Seth: Thank you.

Senator Enverga: Thank you, chair, and thank you for the presentation. Actually, this is long overdue. I have a feeling it's long overdue because my mother-in-law was prescribed a drug. She had internal failure right away, and this hopefully will not happen if we have this law.

I know the big pharmaceuticals must have heard about the bill that you have been trying to pass. Have they made any response to you at all? Have they talked to you about this?

Mr. Young: Yes, they have, and I'm chuckling because I chuckled when they talked to me. I was at a reception before Vanessa's law was passed at third reading in the house, and they came to me and they said, ``We want you to know we really support Vanessa's law.'' So I smiled and said, ``Well, that's really interesting because I'd just like to ask you why you didn't implement anything in the law all by yourself in the last 14 years? Because there was nothing preventing you from taking any of these actions to make patients safer.''

But they went on the record in the hearings in committee saying they support the bill. As I said in my opening remarks, they are already working to try to undermine it.

Senator Enverga: That's very good; thank you.

Mr. Young: If I could just add, senator, in response to Senator Seth's question, rather than just ordering a drug off the market, the minister has the power to order label change under this bill. If the label gets to doctors and it's unclear, as most of them are, frankly, right now, she can order a clearly worded letter to be written to every doctor in Canada, every health care practitioner, saying, ``Be alert to this.'' Then they can watch to see if the doctors have taken in the message and have changed their prescribing habits. The minister has the power to do newspaper ads if she wants to.

The Chair: Thank you. Well, Terry, there are a lot of things that I would like to be able to discuss with you today, but you're the first witness in this process and I'm chair of the committee, so we will hold those for a later time. We are looking forward to the discussions as we go forward on this, culminating with the minister and with the officials to tie this up, and we will see how this goes.

At this particular time I, again, on behalf of the committee, want to acknowledge your role in bringing this bill forward, and, based on its promise, the potential for Canadians as a result of this. I can't go further than that today because we haven't finished our hearings yet or know what our recommendations will be.

At this time, I want to acknowledge your role in getting the measure to this point, and we look forward to discussing things with you at some point down the road.

On that note, I thank you for appearing here today.

Colleagues, for this panel we have three witnesses. By agreement, I will call them in the order that they appear on the agenda today.

Before we start, I need to ask permission from the committee. We have received a submission from one of the presenters today and it is in English only. Copies are being made. Do I have your permission to accept that today before translation can be done?

Senator Chaput?

Senator Chaput: Yes.

Hon. Senators: Agreed.

The Chair: Thank you, committee. When those are received we will circulate them to members of the committee.

On that note, I'll remind us that we are studying Bill C-17, An Act to amend the Food and Drugs Act, the short title being ``Protecting Canadians from Unsafe Drugs Act (Vanessa's Law).''

We are very pleased to have three witnesses with us today representing three important organizations. As I indicated, I will call them in the order that they appear on the agenda. I will invite each of them in turn to make a presentation and then I will open the floor to questions. In any event, the meeting will end no later than 6:15 today.

The first presenter will be Alies Maybee, who is patient leader with Patients Canada.

Alies Maybee, Patient Leader, Patients Canada: Thank you very much, honourable senators, and everyone else.

Patients Canada is devoted to bringing the patient perspective to health care. We believe that individuals generally want to make smart decisions about their health and you cannot do that without good and complete information.

We also, some of us, with the organization and elsewhere, are trying to partner with health care organizations to work together to improve health care. Again, we can't do that without full and complete information. I'll leave that as, if you will, a frame.

With regard to Bill C-17 directly, we're very pleased to see the increased oversight over the life cycle of the use of a drug and very much support that aspect of the bill. We also support all the efforts in the bill for increased transparency.

I would conclude by saying that we would like to see more transparency. The question of the word ``may'' was raised earlier, and that struck me as well because I would hate to see too much wiggle room in the bill for things not being as transparent as possible.

I think that's pretty much everything I need to say at this moment. Thank you very much.

The Chair: Thank you very much. I will now turn to Janet Currie, who is a representative of the Psychiatric Medication Awareness Group.

Janet Currie, Representative, Psychiatric Medication Awareness Group: Thank you very much for your invitation to speak to you today.

I would like to reiterate the concerns our organization has in relation to prescription drugs and medical products that is the safety and protection of the health of Canadians, effectiveness and transparency around decision making, and information that may affect safety. In that sense we feel this bill is a really good start in terms of providing a framework to address those issues.

I'd like to deal quickly with some points on which I have concerns. We feel that granting Minister Moore the power to request information from manufacturers about a drug when they consider there is a risk to health and the power to order a recall are good measures in terms of giving more capacity to the minister. However, we do not understand and would like more detail on the criteria that will be used to assess what risk to human health is.

In negotiations and discussions with Health Canada over the years, they have been unable to describe to us the signals and the trajectory of decision making that would identify risk. We also feel that the recall option is, as someone mentioned earlier, almost a nuclear option. What happens if there is some safety testing of a drug that the minister deems to carry possible risk? Does this remain on the market, or is it recalled? I anticipate that the recall option will only be used in extreme circumstances. We need some more mid-steps so that the minister has the capacity to perhaps temporarily suspend the authorization while safety testing is done.

We also have to be prepared for the resistance that the pharmaceutical companies will make to these options in the bill. I would like to see more details on the appeal process and the length of appeal processes that pharmaceutical companies will have. Second, the issue of the minister being able to ask for safety testing within the bill is an excellent first step. It applies to off-label prescribing, where the drug is already on the market and is being prescribed for a range of uses. However, again, what constitutes risk? There are many questions around safety testing. Who conducts the test? Who designs the test? We do not believe pharmaceutical companies that produce the products should be overseeing or coordinating the test. We feel that needs to be a neutral body.

We would like to see the results of that safety test go to the public or, at least, the public, as well as the minister, have access to those results.

My third point is the issue around institutions being tasked with collection of adverse drug reactions. In principle, we are positive about institutions being used for this purpose. However, to make this successful we need to resource Health Canada to support the collection of adverse drug reactions. This does not work unless there is a champion at each institutional site and there are ways of incentivizing health professionals to make reports. My concern is that Health Canada does not currently have the resources to support that. I'm also concerned about proprietary and commercial interests being brought up as barriers to the implementation of this bill.

In closing, I would like to say one more thing: In terms of the capacity to implement this bill, Health Canada has had decreasing resources around issues such as compliance, monitoring of adverse drug reactions and identifying signals. Unless there is more capacity on this side of the ledger, I am very skeptical that we will see this being implemented effectively.

I urge the committee to underscore the importance of resources and also to create some benchmarks to see if the act is having the intended effect of protecting the health and safety of Canadians.

I have some information about a drug right now that is banned in the United States and where ongoing research has shown that it is being increasingly prescribed off label in Canada. I'd like to know if that's one of the first drugs that will be looked at in terms of safety testing. I'd be willing to talk about that a bit later. We need benchmarks. We need to measure the impact of this act to see whether it is going to actually improve the health and safety of Canadians.

The Chair: I will now turn to Christine Janus, who is a board member with the Best Medicines Coalition.

Christine Janus, Board Member, Best Medicines Coalition: Thank you, senators, esteemed colleagues. I want to thank the committee for having me and for including patients in the review and the discussion on this legislation. We give credit to Health Canada officials for the work that they have done and for having the foresight to involve patients in the process. I am here today as a board member of the Best Medicines Coalition, representing the voice of patient organizations from across Canada.

The Best Medicines Coalition is keenly interested in health policy and in getting patient involvement in the development of health policy and our focus has primarily been around pharmaceutical issues in Canada.

The Best Medicines Coalition is an active member of the International Alliance of Patient Organizations, where we gain a perspective on best practices in other countries. My colleagues from the Best Medicines Coalition have been closely involved, over many years, in —

The Chair: Could I ask you to slow down a little bit with regard to the translation, please?

Ms. Janus: Oh, sorry. Okay, I'll go slow.

The Chair: I appreciate your efforts to deal with time, but —

Ms. Janus: Okay. My colleagues from the Best Medicines Coalition have been closely involved, over the years, in discussions and consultation with Health Canada on this legislation because we believe it to contain important safeguards for Canadians. The Best Medicines Coalition is very supportive of this legislation.

I'm here on behalf of the Best Medicines Coalition but also serve as executive director and CEO of the Canadian Skin Patient Alliance, which is a for-patients-by-patients organization that offers support, education and advocacy to the 10 million Canadians who grapple with skin conditions at any given time. It is also an umbrella organization for over 20 dermatological condition-specific patient support organizations supporting Canadians.

I also act as executive director and CEO of the Canadian Association of Psoriasis Patients, which serves roughly 1 million Canadians living with psoriasis and psoriatic arthritis.

I've been living with several dermatological conditions for most of my life and, more recently, with two relatively rare ones, which are also systemic, inflammatory conditions. I take a cocktail of medications daily and have concerns about interactions and adverse reactions. My family members also take medications for several conditions, and we like to believe that Health Canada is vigilant and has the power to ensure the safety of the medications available for sale in Canada.

Over the past eight years, I've learned more about the health system in Canada and its limitations, and I've joined my colleagues in patient advocacy in seeking solutions to enhance patient safety. We've expressed great concern about the limitations Canada currently faces with respect to post-market surveillance.

The Best Medicines Coalition serves patients with a range of moderate to severe and often complicated chronic conditions, as well as diseases with higher risks of mortality. All of these patients rely on medications, and they have a critical need to have confidence that the medications they take are safe and are closely monitored for safety over the life cycle of each drug. Information germane to their continued health with respect to their medications, their interactions and their adverse reactions needs to be communicated in a clear and timely fashion in order to avoid unintended adverse reactions.

Despite the inherent risks of taking medications where it's widely accepted that every medication has the potential to have side effects, these patients need access to medications. So we don't want to see any limitation of access to medications. They also critically, though, need to have full knowledge of both the benefits and the risks so that informed decisions can be made.

Bill C-17, Vanessa's Law, is surely a step in the right direction. The Best Medicines Coalition supports this amendment to the legislation and urges the committee to move forward without delay. It's high time that an act created almost 40 or 50 years ago enter the modern age and reflect the complexities of our time. We need to have better post-market surveillance in Canada and a regulatory framework that supports it. Health Canada has made great strides forward recently with MedEffect and with some of its initiatives but operates under constraints that impact its ability to access information that's needed. Also, given the fast track process recently put into place for biosimilars or subsequent-entry biologics, where the pre-market requirements have been abbreviated, there is an even greater need for rigorous post-market surveillance. Our governments need both the ability to collect safety information and to take strong action when they identify issues. We believe it's important that reporting be mandatory and that there are tougher measures for noncompliance. We have a keen understanding of the pressure exerted on all of the stakeholders in this arena and are aware that there are some contentious issues, which we expect will be resolved. However, we feel strongly that an approach that puts patient safety front and centre above all other considerations is surely the correct one. Our position as a voice for Canadian patients is that patient safety must come first. We favour the passage of this legislation without delay. It's long overdue and represents progress in ensuring patient safety in Canada. We laud the government for hearing the patient's voice and reiterate the importance of continuing to involve patients every step of the way as the legislation moves through the regulatory phase and through implementation and on an ongoing basis, moving forward. We look forward to continuing to work with Health Canada, and, again, I thank you for the opportunity to add our voice today to this important review.

The Chair: I will open up the floor for questions and I'm going to begin, by earlier agreement, with the sponsor of the bill in the Senate, Senator Seidman, to be followed by the representative of the opposition in the Senate and deputy chair of the committee, Senator Eggleton.

Senator Seidman: Thank you very much for presentations. If I might, Ms. Maybee, you made a couple of points about language. One has to do with the word ``will,'' as also put forward by Senator Eggleton. I'd just like to ask if you are aware that the use of that language, those particular clauses, are paralleled in the Food and Drugs Act, Safe Food for Canadians Act and that has never prevented the minister from exercising the powers that are granted there?

Ms. Maybee: I am aware of that, and I believe it was the word ``may'' that was concerning me.

Senator Seidman: The use of word ``may'' is in that act?

Ms. Maybee: Yes. I read the act and I saw there were parallels. I am not a legislator. As a lay person, I can say ``may'' signals to me there is an option to do something or not. I strongly urge that we have increased transparency, whether there is a need to pass this bill as a first step and then move to being a little bit more stringent. That is what we're looking to. We want to move to more transparency. We want to move to more information for citizens so they can make informed choices. I agree with my colleagues; this bill is a good one.

Senator Seidman: Thank you, I do agree with you on that one. To follow that line and the issue of ``may'' and ``shall'' that you're having trouble with — I totally respect your opinion on this — are you aware that in this bill, the new authorities given to the minister create obligations so it's very clear the minister has an obligation to make any orders for certain powers publicly available, for example, to acquire information, obligations for recall, obligations for label changes, obligations for assessment, obligations for test, retest and more studies? That is in this legislation as an obligation on the minister. So with the use of the words ``will'' or ``shall'' — legalistic, I'm not a lawyer either and so I may not understand all the implications of all these small words, but the fact is that these are new authorities that are very well-defined in the legislation as obligations on the minister.

Ms. Maybee: Yes, I saw that they were obligations, and that there is more obligation to make the information public. The ``how'' of it is also of interest to me because sometimes these things can be made public, they are buried somewhere deep and it is difficult for people to access or the information may only be accessed through a channel that the public is not necessarily aware of.

Again, as a member of Patients Canada, we would like to see that the information is readily available, it is clear and we understand what it is. And it would be nice if this bill can be translated into lay language for the rest of us so we understand it when it becomes law, which I hope it will.

Senator Seidman: There is no doubt we all have, as our primary concern, the safety and health of Canadians. I know you speak with that voice. It is of the utmost importance and the point very much of this bill.

Ms. Maybee: Thanks for the question.

Senator Seidman: Ms. Currie, you referred to a nuclear option and if I'm correct, the nuclear option is the current existing situation.

Ms. Currie: I meant the option, the authority to order a recall of a drug, which is a very strong response to a safety issue. My point was that I would like to see some steps, because it's sort of like a judge saying you have life in prison and then the judge is looking at all kinds of different levels of safety concerns, perhaps.

I gave the example of a drug that would be required to have some further safety testing, an off-label drug. The jury is out but there is sufficient evidence to require safety testing, which is an arduous process. The minister will not call for that unless there are serious concerns, but would the minister recall the drug without the data being in? I'm concerned about temporary; I'd like to see some pre-steps, pre-authority so that we're not just looking. If you have an extreme measure with a lot of implications, people would be reluctant to use it. That's my concern.

Senator Seidman: You are distinguishing between what exists today as the nuclear option, which is a total recall on the current one.

Ms. Currie: No, I'm saying the order to recall as the nuclear option — sorry, I could not think of a better word — as an extreme measure. When there are extreme measures with a lot of implications, no manufacturer will welcome that. I would like to see some intermediary steps that could be taken, which would not go to that extent but would also protect, in the interim, the health and safety of Canadians.

Senator Seidman: As opposed to just the recall of a single drug?

Ms. Currie: Yes. I'm not opposed to the minister having that authority. I'm pleased about it, but I do think that's the end of continuum.

Senator Eggleton: Well, I thank all three of you for being here and Ms. Maybee, I agree about ``may.'' ``May'' can also be ``may not'' and yes, there are these supposed obligations but there still is a lot of wiggle room for exemptions in certain areas. So that has to be watched and we'll have to get a little bit better handle on the legalese here; I agree with you.

Ms. Currie, I quoted you in my speech on second reading last week. I quoted you as saying how fundamental you thought disclosure was. It was in reference to clinical trials specifically, but I just want to check to make sure that that quote is something that you think applies across the board here. Here it is:

. . . researchers and the public can evaluate the safety and effectiveness of a drug without having full access to clinical trial data, to the history of clinical trials, to the outcomes of clinical trials.

I take it that's a general comment you were making?

Ms. Currie: Absolutely. Not only is the registration of clinical trials important, but whether they have been completed and what the outcomes have been. As you know, there has been much more research done on looking at the whole scope of clinical trial outcomes and the first time I heard this I could hardly believe it. I have to ask if it is true that a company only needs two positive clinical trials for a drug to be approved. They can have 10 other clinical trials that were ambivalent and some negative, as long as it has that minimal number.

If you look at Prozac, for example, which was the beginning of the SSRI revolution in terms of antidepressants, there were many clinical trials with that drug that had questionable or ambivalent results. It is the same with a lot of the other anti-depressants, and more has been written about this. Full disclosure of not only what clinical trials are registered but also the positive and negative results that the public can access in some way is important.

Senator Eggleton: This follows up on Senator Seidman's questions and your comments about the recall tool.

You're advocating a step process because you're saying that there may be a reluctance to use it. The minister has to, I think according to the act, believe there's a serious and imminent risk and, yes, that's a bit heavy. You're suggesting that there may be a reluctance to use it. Do you think that reluctance might also come from the fact that these pharmaceutical companies are very litigious?

I've noted that Eli Lilly is suing Canada for $500 million saying it violated its obligation to foreign investors under the North American Free Trade Agreement by allowing its courts to invalidate patents for two of its drugs. That's a little different than recall, but nevertheless I think it demonstrates that if they're going to start losing sales they might quickly end up — of course they may not succeed — but they sure get a lot of money, as we well know, to be able to drive this into the courts. This could create a chilling effect on the part of any minister in terms of implementing this. Do you see that as part of this concern?

Ms. Currie: Absolutely, and that's why I made the point about really wanting to see some details in the act around the appeal process that drug companies will have. If a recall is mooted or discussed or called for by the minister, there certainly has to be an appeal process.

What we know from appeal processes in the past, even on changes of labels, that the minister has the authority to change a label, but what will the appeal process be and how long will it be drawn out? I would be extremely surprised if there isn't an appeal process built into the regulations. You have a drug that's questionable, whether safety issues have been defined, and how long is the appeal process going to take and how many more Canadians are going to be exposed to harm while that's taking place?

I agree with you in terms of the litigious nature of the companies and that we need to understand what that process is going to be and how it may evolve.

Senator Eggleton: Towards the end of your comments you talked about risks, first of all, and particularly in terms of off-label. I think you said you had an example. Could you tell me about that?

Ms. Currie: Yes, can I talk a little bit about a drug called domperidone? Domperidone is a drug that was tested and approved for nausea, and so it is sometimes used in oncology. It is a drug that has an off-label use of causing or enabling lactation among women. So in the breastfeeding community it is being very widely used. There's some research coming out of B.C. showing there's been an absolutely exponential use and prescribing of this drug at high doses for women who are healthy and have had full-term babies. One has to question why they are using this drug.

This drug is banned in the United States for all purposes and has been so for many years. I have a scientific report here that shows, no question, there is complete consensus. The studies are unambiguous in identifying it as able to produce — and it's very technical language — marked HERG channel inhibition and action potential prolongation. That's the QT prolongation, which I believe was a factor in Vanessa Young's death. This drug is being given to healthy women having given birth and it's going directly to the baby.

So cardiac abnormalities, this is a drug that I would put on my list of safety studies or even recall, because it is banned in the United States.

Senator Eggleton: But not here?

Ms. Currie: Not here, and I'd like to know why. As I say, there is research coming out of B.C. showing that the use of this drug is expanding. What concerns me is that this is going to newborn babies.

Senator Eggleton: Maybe this demonstrates that there could be reluctance on the part of Health Canada to use the recall measure if they're not even doing anything about it at this point.

Ms. Currie: It's an extreme option. Let's say that this might be a drug where they'd say they have safety concerns and are going to order safety testing. I still have concerns about who does the safety testing, what's the time frame and what are the compliance measures.

Senator Eggleton: Okay.

Ms. Currie: But while you're doing the safety testing, wouldn't you want to suspend use of it? That would be my question.

Senator Eggleton: Suspend it.

Ms. Currie: Maybe not withdraw it at this point, but suspend temporary use of it.

Senator Eggleton: Okay, thank you very much.

[Translation]

Senator Chaput: My first question is for Ms. Maybee. You partially answered it when you responded to Senator Seidman's questions. However, I would like to clarify something.

You represent patients, and you are especially concerned about ensuring that the information they receive is accurate, complete and comprehensible. Can Bill C-17 provide you with more transparency, so that you could receive better information in order to satisfy that concern?

Ms. Maybee: I think so. I will continue in English.

[English]

I believe it's moving in that direction, and we can't always win every battle all the time. This bill moves us ahead and it provides, as my colleagues have suggested, a very strong platform for advancing even further. I would really like to see, ideally, that all the information that we've talked about in terms of drugs and adverse drug interactions and so on are available to the public in a very easy-to-digest manner. That may not happen initially, and I understand that, but we need to move forward and I think this bill will do that.

[Translation]

Senator Chaput: Ms. Currie, I would like to raise two points. You said you would like to see what criteria would be used to identify risks and do recalls. Can you give us examples of those criteria? They are often part of regulations or enforcement.

Ms. Currie: Criteria for risk identification?

Senator Chaput: Yes, and also for recalls.

Ms. Currie: The task is a difficult one. Testimony and data from various sources must be considered. I think Health Canada is currently lacking a risk identification system. The task is difficult because many elements need to be considered, such as the number of deaths, the number of injuries, and the types of problems involved. A number of factors have to be considered before a decision is made.

Senator Chaput: And that is currently not the case?

Ms. Currie: I do not think so. It is hard to ask Health Canada to confirm its decision-making process.

Senator Chaput: My next question is about Health Canada. It is somewhat direct. In your opinion, does Health Canada have sufficient resources at its disposal? Should or could the resources be used differently?

Ms. Currie: I think that a lot of resources are dedicated to drug approvals.

Senator Chaput: Approvals?

Ms. Currie: Drug approvals and the speed of the process. Resources should be transferred, so that the problem and the negative effects could be monitored. In my opinion, resources should be transferred.

Senator Chaput: Ms. Janus, I have one last question. I think we all agree that Bill C-17 is a step in the right direction.

Are there any elements you would have liked to see in this bill that are lacking? If so, can you give me an example?

[English]

Ms. Janus: I think I agree with my colleagues that we feel that this is a step in the right direction, but we would like to have seen plain language. We would like to see it to be firmer, rather than ``may,'' ``will.'' But we are concerned that if we bring forward any other changes, then it will slow the process down, and we would like to ensure that this gets passed as a first step, and then we whittle away at it bit by bit.

Senator Chaput: And then work on another bill?

Ms. Janus: Exactly, or an amendment.

Senator Chaput: Thank you.

Senator Stewart Olsen: Thank you for your very interesting and thoughtful presentations. I am always amazed at how much I haven't considered and that our witnesses bring forward, and that starts me thinking, so thank you.

I have a couple of questions, one on the reporting of adverse drug reactions. I believe, Ms. Currie, that you wanted more resources dedicated to reporting. Why would that be?

Ms. Currie: Health Canada did a pilot project a couple of years ago using hospitals and health institutions to report problems with medical devices. It was a pilot project, and they had a very keen coordinator who had champions in each of the institutions to encourage reporting because data shows us that health professionals don't like reporting. It takes time and they don't want to do it. So if you legislate reporting or you require reporting, the compliance rate is low.

Unless you actually have resources in the institutions to support reporting, you're not going to get a good result. That takes time, effort, networking, relationship building, monitoring, tracking, looking at the data, interpreting the data and seeing what it means.

I worked with the person who was coordinating this pilot project. Health Canada couldn't even muster up the resources to do a proper evaluation of that project. I was really surprised at — I have to say — the Mickey Mouse approach they used to aggregating some of that data because it was a good project.

I am concerned about bringing a more robust framework if you're going to use institutions as a major source of adverse drug reactions.

I didn't mention in my presentation that I am concerned there is nothing mentioned in the act about consumer reporting of adverse drug reactions. That is a huge oversight, and I hope this committee will address that because consumer reporting of adverse drug reactions is very different from institutional reporting. They are highly qualitative in many ways, and there are often distant early warning systems for drug problems.

The problems of addiction and withdrawal from psychiatric drugs were not identified by huge databases by health authorities. They were identified through a BBC program called ``Panorama,'' where so many people called in and reported their personal experiences that finally others had to take notice.

I don't know if that's a deliberate omission in the bill or it's not seen as necessary to mention, but I am concerned about it not being in the bill.

Senator Stewart Olsen: Thank you for that, and I believe fully in expecting the responsibility to be assumed by our health care professionals for this, not resourcing it and having a person there to say, ``You fill that out.''

I was appalled when I heard that many institutions don't do adverse analysis because in the institutions that I worked in, we had to report adverse drug reactions, and it was a part of our professionalism to do it. I would rather see the onus there. This is a very important part of your job, and if you fail to do that, then I think we would get more out of expecting the professional organizations to monitor something like that than we would to say, ``Oh, we need more money,'' but that would be just my observation to you.

The other good point that you all made is the details of the criteria, and I think that's very good to know. In my limited experience of reviewing bills, it generally follows after the bill is passed that the regulations are put in place, so I would watch that with interest on the details of the criteria.

I would welcome it if anyone has criteria that they would like to see to have it sent to this committee, and then we could forward them to the minister. I would welcome that. I think anything would be helpful on that.

Once again, I thank you for your observations. They were very helpful.

Senator Enverga: Thank you all for your presentations. I know your organizations have been representing patients, like Psychiatric Medication Awareness Group, Best Medicines Coalition and Patients Canada.

In your work and experience with patients, has your organization ever made recommendations, such as, ``I want that label changed; I want this instruction to be clearer''? Have you ever made a call to Health Canada saying, ``Can you recall this medicine? This is not good for our patients''? Have you ever done that? Do you think Bill C-17 will be able to help your advocacy?

Ms. Currie: I was on the expert advisory committee for the vigilance of health products for five years over two terms, and that was a mandate of our committee, so as a representative of my organization and also PharmaWatch Canada, we made those recommendations all the time.

I've also done policy documents for the Centre of Excellence for Women's Health in B.C. and for Women and Health Protection, again, saying there are problems with psychiatric drug prescriptions. There are problems with off- label prescribing, for example, of antipsychotics to the elderly with dementia.

I also run a website that makes these kinds of statements on recommendations.

I think one of the big problems is that I have many people coming to me privately, even though this is not my paid work, asking me what to do about their elderly mother who is on 22 medications. Quite frankly, after you've worked in this field for a long time, you begin to see that the first two drugs may have been medically necessary, but many of the drugs that came after were to deal with the side effects of the first drug or the first couple of drugs.

For example, you're getting nausea from taking a Parkinson's drug, so you get an anti-nausea, and then that creates other problems so you get another, and then you're upset and anxious. Just to take an example of the elderly, where does one go with that information? We also need, in Canada, some system of helping people to taper off unnecessary drugs successfully.

Senator Enverga: But have you made any recommendation?

Ms. Currie: Yes.

Senator Enverga: You said you made recommendations. Can you give us some more details? What happened to the recommendations?

Ms. Currie: Well, I made a very strong recommendation to the Government of B.C. about developing a system exactly like that. I made those recommendations in the expert advisory committee.

I'd like to mention the expert advisory committee because that is an excellent forum for the implementation, tracking and monitoring of this bill. It is multidisciplinary; it is made up of consumers, researchers and physicians. That committee is almost inactive. It hasn't met for two years.

Senator Enverga: Are there are any medicines that you thought, while you were working with patients, were harming your patients? We want Health Canada to work on this. Have you done that?

Ms. Janus: Our organization, to my knowledge, has not done that. The thing is there is a helplessness among patients, so it's not like they'll come forward and say it's this or that drug.

Because of the ``cocktail'' taken by many people, they don't really know which drug is to blame and where to find that plain-language information that will give them the information that they can take forward to someone. There is too much information on the Internet that is conflicting and too much that's not clear. Plain-language information for patients that they get through their doctors or through a trusted site would be a great help.

Ms. Maybee: As an organization we haven't lobbied specifically for drug changes because we have a more general mandate. I am aware of members of our organization who have had concerns about drug cocktails and so on who have gone ahead and created personal websites to deal with drug interactions because there's nothing out there. When you have citizens stepping up to do things that would be helpful if the government could do it, then you know there's a gap.

Ms. Currie: It's actually risky. I design tapers for people coming off psychiatric drugs. It sometimes takes two or three years, and I always work with the physician. This is a risky business. There are huge gaps. I'm not suggesting that this bill will address those, but I'm saying those are continuing gaps that will exist even after the bill.

The Chair: I think you will see some document emerging from us very shortly, senator, that you are part of that will deal with a lot of this.

Senator Seth: Thank you for your presentations. They were very interesting.

Do you believe that the proposed mandatory disclosure of adverse drug reactions or the medical device incidents according to clause 21.8 would affect a person's protection or personal health information? If so, how can we ensure that we would protect the privacy of patients?

Ms. Currie: What was the clause?

Senator Seth: Clause 21.8.

Senator Eggleton: ``A prescribed health care institution shall provide the Minister, within the prescribed time and in the prescribed manner,'' et cetera. Is that the one? Okay.

Ms. Currie: Can you read that section?

The Chair: Clause 21.8 reads:

A prescribed health care institution shall provide the Minister, within the prescribed time and in the prescribed manner, with prescribed information that is in its control about a serious adverse drug reaction that involves a therapeutic product or a medical device incident that involves a therapeutic product.

Ms. Currie: That is all anonymized data, as far as I can see. It's exactly the same kind of reporting done now by the drug companies. The drug companies provide most of the data on adverse drug reactions to Health Canada. This is a supplementary form of collection of data and it would all be anonymized. There would be no patient identifiers once it's sent to Health Canada. I'm assuming the reporting forms would be anonymized as well in some way.

Senator Seth: Medical devices would still be anonymous?

Ms. Currie: It would be anonymized as well. It would also be aggregated because unless it's aggregated you're not going to see patterns. Unless you're looking at overall numbers, prevalence and percentages, you're probably not going to start identifying a pattern, so it would be in an aggregated form.

Senator Seth: I wanted to know how others will act because we do this. We just don't have to give the names. It will just be given as ``person A'' or person B'' and not disclosed because of privacy.

Ms. Currie: That's right.

The Chair: Before I go to Senator Eggleton for a final question, I wanted to address, Ms. Currie, the issues of language that have come up. Since we have Health Canada officials in the room, and they will be appearing at the end when we collect all of the issues that we want them to address, I bring up the issue of ``may.''

This relates to your concern on the one hand, in fact you express two sides of the concern: that the recall could be too dramatic, too immediate; on the other hand, you were concerned whether the minister would even bother to pursue these issues, if I heard you correctly with regard to the two sides of the issue.

If I could just finish, the term ``may'' is an authoritative term. It authorizes, yet at the same point it doesn't compel in an absolute sense. If we think about the issue, to take an example arising out of Senator Seth's comment, let us suppose there's a pacemaker involved and there need to be some issues with regard to the product on the market in the future. You can't just yank those out and move forward, there has to be a way of dealing with it. We will ensure this issue is raised on the record before we complete our study, because it is a very important interpretation that you have made.

The meaning of the term ``may'' causes, on the one hand, suspicion but on the other hand is an authoritative term and gives a degree of flexibility.

Ms. Currie: I have no problem with that.

The Chair: Ultimately it comes down to human beings, doesn't it? The importance is to get a bill that ensures that this is the case. We will ensure this question is raised with the officials before we are finished.

Ms. Currie: I understand the legal import of the word. I didn't have a problem with the use of ``may,'' it was more the range of options that I was concerned about.

The Chair: Thank you very much. Your input is very important to us, so I want to ensure we get it understood, and the question will be answered in the end.

Senator Eggleton: I want to go to the matter of a prescribed health care institution and what it is. Ms. Currie, you mentioned it, but I invite the others to comment on it as well.

It's not defined in the bill; it's to be left to regulations. Most people seem to assume it means a hospital. It could mean a clinic or some other things. It doesn't seem to go to the extent of meaning a physician. There is a concern about the burden on a physician of doing that.

The attempt here is to get more reporting on adverse drug reactions than what we do get.

You're saying that this bill is too reliant on this source of information, so I take it you're talking about the hospitals. You mention consumer-based reporting, but you couldn't require that. How would you do that? What else do any of you think should be included in this definition of ``health care institution'' when we get to the regulation?

Ms. Maybee: I'll jump in quickly, if I may. You will see adverse drug reactions happening in long-term care facilities, which are not hospitals. You may see them coming out of community care, the home care situation as well. I would urge a somewhat broader, not just hospital, approach to health care institutions.

Ms. Janus: I would concur with that.

As to your question around how we would gather information from consumers or patients, I actually think that Canadian patients would welcome the opportunity to provide information. If there were a forum or a website that they could register their issues within, I think you'd probably get more information than you might actually want. Then somebody will have to read it, which takes us back to the resource issues, but I think Canadians would embrace that.

Ms. Currie: I think the intent of Health Canada, from my discussions with them, is to have a range of institutions reporting. So, again, I think it's a good system. I like the signal system. I thought the project that they did on medical devices, which was the first they have ever done in Canada on medical device safety, was an excellent small pilot project. My guess is that they are intending to build on that, and having a range of institutions — long-term care facilities, community clinics, family clinics — is an excellent point.

My question and concern around consumer reporting wasn't that I think it's going to be dumped. It's just not in the bill, so I'm concerned. Is it going to be dumped? I just have a question. Is it going to be dumped or is the institutional reporting expected to replace it? That's just a question I have. I don't have any knowledge, really, of what the answer is.

Senator Eggleton: In terms of an easy-to-access, friendly method of reporting on the part of consumers, that doesn't exist.

Ms. Currie: Actually, I believe that there are four regional offices people can phone.

Senator Eggleton: Health Canada?

Ms. Currie: Yes. There are adverse-drug-reaction reporting offices. I'm assuming they're still funded. They're excellent. The people who take the reports are excellent, very consumer friendly. There are reporting forums online that I think are less consumer friendly. The thing is that nobody knows about it.

Senator Eggleton: Yes. I didn't, or I wouldn't have asked you.

Ms. Currie: I have never gotten anything but good feedback if people phone and do a report online, but how many of you have made a report? I'm sure there are many people in this room who have had some kind of reaction to something. Have you made a report? Some drug inserts will actually give you the number you can phone to make a report. It's not in our culture to do that, and it's going to take a while. I think this bill could actually help to promote that culture, which, I think, is what we need to do.

Ms. Janus: I have one more comment. The inserts are written in mouse print, and so most patients don't read those. I also want to harken back to putting the onus on the physician. As you said, senator, it's part of their job, and it should be part of their job. When we look at the shortage of specialists and the time crunch that they're under, I'm familiar on the side of dermatology, and some dermatologists don't take on the complicated cases because they don't have the time. If we're putting the responsibility on them to make this work, I have concerns about that.

Senator Eggleton: Okay, good points. Thank you.

The Chair: Thank you very much. In fact, on the issue of the definition of a health care institution, I think that that was deliberately included in the language to allow it to be expanded beyond the hospital situation and that those will appear in further definitions.

With regard to adverse drug reporting, this committee has studied that in great detail and has made and will make recommendations in the area because the issue is to facilitate the issue, not always to have it in a legalistic form but to facilitate the collection of information in a manner that is useful. These are all very important issues that will clearly form part of the ongoing development.

I was very interested to hear that you all felt that this bill was a good basis for us to move forward in that regard, and, as some of my colleagues have already mentioned, you represent organizations that have a great deal of experience in these areas of dealing with patients and the real world issues of the employment of medical devices and pharmaceuticals. So your contributions to us are tremendously important. You've raised issues that clearly have to be raised, like the regulation issue. We will clarify interpretations of some of the key issues that you have raised today.

With that, on behalf of the committee, I thank you very much for your appearance today, and I declare the meeting adjourned.

(The committee adjourned.)


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