Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 20 - Evidence - October 2, 2014
OTTAWA, Thursday, October 2, 2014
The Standing Senate Committee on Social Affairs, Science and Technology met this day at 10:28 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 from Nova Scotia. I would ask colleagues to introduce themselves.
Senator Seidman: Judith Seidman from Montreal, Quebec.
Senator Stewart Olsen: Carolyn Stewart Olsen from New Brunswick.
Senator Seth: Asha Seth from Toronto.
Senator Enverga: Tobias Enverga from Ontario.
[Translation]
Senator Chaput: Maria Chaput, from the province of Manitoba.
[English]
Senator Eggleton: Art Eggleton from Ontario. I'm deputy chair of the committee.
The Chair: We are dealing with Bill C-17, An Act to amend the Food and Drugs Act. The alternate title is the ''Protecting Canadians from Unsafe Drugs Act.'' It is also known as Vanessa's Law.
We have two sessions this morning. Each one will last one hour. In the first panel we have two groups represented. I will identify them as I call them to present. I remind colleagues that this session will end no later than 11:30 this morning.
By agreement, I invite Mr. Perry Eisenschmid to present first. He is Chief Executive Officer of the Canadian Pharmacists Association. With him is Ms. Janet Cooper, Vice President, Professional and Membership Affairs, Canadian Pharmacists Association. Welcome.
Mr. Eisenschmid, please proceed.
Perry Eisenschmid, Chief Executive Officer, Canadian Pharmacists Association: Good morning and thank you to the Senate Committee for the invitation. As you know, CPhA is the national association representing pharmacists across Canada. We are also Canada's largest publisher of objective evidence-based drug and therapeutic information for health care professionals. Through our print and digital publications, we also provide point-of-care access to the most current drug safety data, including advisories from Health Canada.
Medication safety is a priority for CPhA and for all pharmacists in Canada. Medications, both prescription and non-prescription drugs, should be both safe and effective. Although it is not possible to completely eliminate the risk associated with medication use, pharmacists devote considerable time to counselling patients on the appropriate and safe use of these medications and monitoring their use to improve drug therapy outcomes. This is why CPhA has supported the intent and direction of Bill C-17 since its introduction in December 2013.
CPhA supports amendments to the Food and Drugs Act and increased penalties for unsafe products, the new powers for Health Canada to recall unsafe products, and the requirement for drug companies to revise labels and to clearly reflect health risk information, which could include potential updates for health warnings for children. We also support the minister's powers to compel companies to do further testing or studies on a product when safety issues are identified, including issues with certain at-risk populations.
While we support the content and direction of the current bill, we believe there is room for improvement in a few key areas.
In a previous appearance before the Standing Committee on Health in June, CPhA encouraged inclusion of natural health products within the scope of the bill to help protect Canadians from a widely used category of products, about some of which little is known in terms of safety. Natural health products are medicinal products taken by Canadians with the intention of affecting their health. We iterate that ''natural'' should not be interpreted as meaning ''safe.'' Natural health products have the ability to cause harm and, given their widespread use, CPhA feels that natural health products should be included within the scope of the bill.
CPhA supports the need to improve reporting of adverse drug reactions. Collection of such information provides pharmacists, physicians, nurses and other health care providers with vital information that allows them to make decisions on the best course of action when medications are needed. However, we strongly recommend that greater clarity be provided with regard to the content of the bill related to the section on adverse drug reaction reporting. From the point of view of health care providers, this section of the bill does have the potential to cause undue harm and confusion since the current wording of the bill can be interpreted differently.
Specifically, proposed section 21.8 mandates the need for adverse drug reporting by stating the following:
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 . . . .
The meaning of this is not clear. What act exactly is a ''prescribed health care institution'' that needs to provide ''prescribed information?'' Is a community pharmacy or a community health care centre such an establishment? It would be helpful to clearly define what venues constitute prescribed institutions.
What is an ''adverse drug reaction''? A clear definition for ''serious'' is needed. Health care providers, including pharmacists, deal with serious adverse events daily. Practitioners are busy and we need to support them in the reporting of new or unexpected patient safety information — we don't need unnecessary paperwork. For example, is it really important to report serious drug reactions that are already well-known? Many of these reactions are well documented and may be an expected event in the delivery of health care. An example would be with anticoagulants and oncology drugs. The utility and duration of reporting such an event needs to be considered. Wouldn't time be better spent on efforts to report adverse events that are previously unreported, underreported, not well-known or unanticipated? Serious adverse reaction reporting for events that are not well documented serve great value in helping to better inform health care providers and patients of the risks associated with particular therapies and to support Health Canada in further actions based on identified risks.
But reporting is just the first step in this important process. Once these issues are clarified, Health Canada needs to set up a transparent and accessible method for health care providers and the public to both access and use the information collected. As pharmacists, we believe that Health Canada should be transparent in the provision and aggregation of the information it receives from mandatory reporting, but the current legislation is unclear on whether and how this information will be analyzed and shared. Providers need access at the point-of-care to inform their decision-making and treatment plans — ideally, this will be seamlessly integrated into their electronic patient care systems.
In short, Mr. Chair, the Canadian Pharmacists Association continues to be supportive of Bill C-17. Given pharmacists' focus on safe and effective use of medications and CPhA's commitment to ensuring health care providers have access to current, Canadian, evidence-based drug, therapeutic and safety information, CPhA believes that this legislation is a major step in the right direction. However, there are some improvements and clarification that would make the bill even better. As always, CPhA is ready, willing and able to support this effort.
Thank you, Senator Ogilvie and committee members, for the opportunity to meet with you today. We would be pleased to respond to any of your questions.
The Chair: Thank you very much.
I will now turn to HealthCareCAN and Bill Tholl, President and Chief Executive Officer; and Myrella Roy, Executive Director, Canadian Society of Hospital Pharmacists.
I understand you are sharing your time. Mr. Tholl, please begin.
[Translation]
Bill Tholl, President and Chief Executive Officer, HealthCareCAN: Mr. Chair and members of the committee, thank you for the opportunity to speak to you today. This morning, I will be giving our presentation with my colleague Myrella Roy, the executive director of the Canadian Society of Hospital Pharmacists.
[English]
I am Bill Tholl, President and CEO of HealthCareCAN, the national voice of health care organizations across the country. We were formed this past January from two legacy organizations: the Canadian Health Care Association and the Association of Canadian Academic Health Care Organizations, or teaching hospitals, across the country. We foster informed and continuous results-oriented discovery and innovation across the continuum of health care.
With respect to Bill C-17, An Act to amend the Food and Drugs Act, I wish to make three overarching points. First, our members are strongly supportive of this legislation. It will enhance public and patient safety and will build on existing reporting mechanisms. In addition, our health care organizations have policies and procedures in place with respect to reporting on adverse patient safety events and harms that include, but are not limited to, adverse drug reactions and those related to devices.
I remind the committee that the reporting practices of health care facilities across the country already address issues around adverse reporting under the Accreditation Canada Certification Program. As well, HealthCareCAN has launched a series of programs with our colleagues, the Canadian Patient Safety Institute, including the Canadian Patient Safety Officer online program designed to build a strong patient safety culture within our organizations. We support the broad goals and objectives of Bill C-17.
Second, this legislation appropriately gives Health Canada and the minister the powers to act more quickly to get dangerous drugs and devices off the shelves faster. HealthCareCan is supportive of the additional powers afforded Health Canada and the minister in terms of the provision of information from prescribed parties; requiring changes to packaging or labelling of therapeutic products; and ordering recalls and requesting injunctions.
However, I would like to highlight some of our concerns. Specifically, we want to work with Health Canada to ensure that there is not an undue increased administrative burden on an already stressed health care system, as my colleague with the Canadian Pharmacists Association has pointed out. As you know, the devil is always in the detail. In this case, the regulation details are provided for under the already mentioned proposed section 21.8.
In this regard, HealthCareCAN strongly recommends to this committee, first, that you report back to Parliament and emphasize the importance of clarity of definitions, as just mentioned, with respect to who are the prescribed health care organizations. Second, what is the prescribed manner for reporting on critical incidents, including issues around timing? Third, clarity as to who is responsible for responding and how quickly to the reports of adverse events. My members are worried about this dropping into a black hole administratively.
We believe that Health Canada will work with us and take all necessary steps to provide minimally disruptive reporting. Let us not reinvent the wheel. Let us build on existing programs such as the MedEffect Canada program. The bottom line, Mr. Chair and colleagues, is that we need a system that will work to advance the health of Canadians without undue additional administrative burden.
Thank you. I will now turn it over to my colleague Ms. Roy.
[Translation]
Myrella Roy, Executive Director, Canadian Society of Hospital Pharmacists, HealthCareCAN: Mr. Chair, thank you for giving us the opportunity to appear before the committee today.
[English]
I am the Executive Director of the Canadian Society of Hospital Pharmacists. Our society strongly supports strengthening Health Canada's ability to collect post-market safety information and to take appropriate action when a serious risk to the health of Canadians is identified, as proposed in Bill C-17. However, we are also concerned about the administrative burden that will potentially be imposed on prescribed health care institutions to report serious adverse drug reactions.
To build on the comments of my colleague from HealthCareCAN about the MedEffect Canada program and its adverse reaction database called Canada Vigilance Adverse Reaction Online Database, health care professionals need this platform to be more accessible and user friendly for the reporting of and learning from individual serious adverse drug reactions.
The Canadian Society of Hospital Pharmacists very much appreciates that Health Canada envisions making full use of existing information management systems to collect ''prescribed information'' about serious adverse drug reactions from prescribed health care institutions. However, we wish to forewarn that determining causality of serious adverse drug reactions by this method will be very challenging. In an affected patient, it can be difficult to determine if a serious reaction is due to one particular drug, the combination of drugs or to the decline of the patient's primary condition.
Furthermore, the proposed new legislation should be expanded, as was mentioned by my colleague from the Canadian Pharmacists Association, to include natural health products. Some natural health products are known to interact with drugs and other natural health products in causing adverse reactions. For example, research has shown that the herbal product ginseng can reduce the effects of warfarin, commonly known as a blood thinner, which increases the risk of blood clotting.
In many ways, the amendments to Canada's Food and Drugs Act proposed in Bill C-17 align with the society's own mission. The society is a not-for-profit organization supporting over 2,900 pharmacists committed to patient care through the advancement of safe, effective use of medications in hospitals and other collaborative health care settings.
[Translation]
I would be pleased to answer your questions in the official language of your choice.
[English]
The Chair: Thank you.
I will now open the floor to questions, beginning with Senator Seidman, who is the sponsor of the bill in the Senate.
Senator Seidman: Thank you for your presentations. I would like to pursue the two biggest issues that came out of your presentations. One has to do with the inclusion of natural health products and the other is the administrative burdens that you speak about.
If I could start with natural health products, in this case, Bill C-17 addresses amending the Food and Drugs Act very specifically in dealing with critical aspects of drug regulation that has not been touched for about 50 years. It is my understanding that the Natural Health Products Regulations were adopted in 2004 and will be on the table for updating after this is done. I think it is not intended that natural health products are not going to be addressed. In fact, I think it was Mr. Eisenschmid who referred to the fact that health products are not necessarily healthy. There are all kinds of issues with natural health products, and Ms. Roy, you certainly referred to the possible interaction effects of natural health products. I think those are critical issues that we wouldn't underplay in any way, shape or form. But that health products piece is now dealt with in a separate series of regulations, and that would be dealt with after this bill. That is the next in line as a separate entity. I am very open to whatever you might have to say about that.
The other issue is the administrative burden. There is no question that this was purposely left open-ended in order to define exactly what we are talking about here. We are talking about specialty clinics. I think it is not intended to include practitioners in private practices, for example, for the very reason that you all talked about, and that is complexity issue. Most practitioners in their private practices don't have the understanding of these complexities to make these kinds of definitive indications as to an adverse reaction, and overloading the system with incorrect information would be just as unsafe and unfair to patients as targeting the real adverse reactions.
The aspect of the administrative burden is important. I would like to hear from you what you think could go into regulations in dealing with the aspects that you put forward — for example, the time issue, what kind of institution should be included and how to reduce that administrative burden.
Mr. Eisenschmid: The issue with particularly community pharmacists, and Myrella can speak about hospital pharmacists, is that they are on the front line and often the first to observe some of these adverse reactions and report on them. I am a bit surprised by your comment. I'm not sure who you were intending, then, to be primarily offering the reporting of adverse reactions, but I think community pharmacists are ideally placed to do that.
The issue is, as we have stated, that a number of adverse reactions are well-known and well-documented. Indeed, there are automated systems to flag that within dispensing software systems and other reference tools. I think there would be a benefit to having community pharmacists and other front-line, health care practitioners participate in the reporting, as long as it is done in a way whereby we are only focusing on those things that are incremental information or beneficial information as opposed to redundant information.
Ms. Roy: I agree with you. It is my understanding that this bill is not really mandating individual adverse drug reaction reporting. It wishes to take advantage of information management systems and information that is available through information management systems in health care institutions. Although you have to read between the lines of the proposed amendments, the way I see this coming to health care institutions is that the prescribed health care institutions will be asked to do data mining from their medical records that would link a prescribed drug to an event that has been flagged. This information would be retrieved from medical records and provided to Health Canada. It is not all adverse drug reactions; it is certain specific reactions that have come to the attention of Health Canada.
The Chair: We will have the minister and officials next week who will clarify this. This is an issue for clarification, and your points are made, so we will not prolong this.
Mr. Tholl: Briefly, we are concerned about the ambiguity in the bill, as my colleague has pointed out. Who will be responsible for it? If it isn't individual practitioners, who is it? Individual physicians do the prescribing. Pharmacists are our first-line defenders in the health care facilities themselves.
It is the ambiguity with respect to timing. How quick is quick enough? As I mention idea my remarks, what is the obligation of Health Canada to respond quickly? Hurry up and slow down, is the way one of our members put it. That is the concern there.
Third, how do you deal with this at more of a system level? This has to do with IT systems, e-prescribing and all those other things that will have to fall into place if we're really serious about intercepting adverse drug events before the fact rather than after.
The Chair: I will move past this particular point for the reason I indicated.
Do you have a quick interjection to add something?
Mr. Eisenschmid: I had a comment on natural health. I appreciate the fact subsequent regulations will be put in place to deal with that. All I would suggest is, as all parties have spoken about, because of the interaction between pharmaceuticals and natural health products, it is well and fine to do something in isolation for natural health products, but it's the interaction between the two that in some cases would warrant a cohesive view of it as opposed to doing things discreetly.
Senator Eggleton: I would appreciate some clarifications from Senator Seidman. Maybe I should ask her questions. I will stick with these people today, though. We'll get together further.
Concerning this whole question of the administrative burden, Mr. Tholl, you said in your comment that you already have reporting practices that are part of Accreditation Canada's certification. Do you think that would answer your question about unwarranted burden? Is it a matter of adapting to that kind of thing? Do you think that would be a good way of meeting the intent of Bill C-17?
Mr. Tholl: It would be a really good start. Start with a good, solid assessment of what currently exists, what is working and what is not. There are other more isolated programs; I know of one in Halifax, for example, that is working quite well. So let's build on the basic minimum, as provided by Accreditation Canada standards, and look at what we need to do in addition to that, but that is a good place to start.
Senator Eggleton: I suspect that the Minister of Health would want to cover these off in regulations and that there might be subsequent discussions with you — hopefully there will be — before those regulations are set. Is that good enough, or do you think there needs to be more clarity in the bill itself?
Mr. Tholl: It's striking the right balance, as you know. Especially if there is ambiguity and we don't know exactly how best to fix it, it's best to do that through regulation rather than through legislation.
Mr. Eisenschmid: As a corollary, part of the issue in the cases cited in some of the background material that I have been reading, it was not the case that the adverse effect was not known; it was either that an automated system was truncating the adverse conditions to only report the top five, in the case of the Diane-35 situation, or it's a case of there being an overwhelming amount of information being passed on either to the health care practitioner or professional or the patient, and, as such, it's not very useable.
Part of the emphasis also has to be on — this is similar to the theme that Mr. Tholl spoke about — better utilization of the reporting that is already in the system and available.
Senator Eggleton: It looks like the regulations will be the avenue for approaching that. It is the same with the health care institutions. Yes, you're right: It isn't clearly defined here, and we are all wondering what that means. Again, we will probably be told that will be dealt with in the regulations. Do you have concerns with that?
The Chair: Before we go to that, I forgot to acknowledge Ms. Roy on the previous question.
Senator Eggleton: You can answer both, if you want.
Ms. Roy: On the point about Accreditation Canada and their standards, their standards — although I do not remember the wording, word for word, how it is presented — there is an expectation or a requirement from Accreditation Canada standards that there would be a process in place to report adverse drug reactions. It does not mean that every single adverse drug reaction is being reported. That is my first point. But obviously you need information about individual reactions in order to feed into information management systems.
That leads me to my second point. To rely on information management systems of health care institutions, as we all know, information management systems don't speak to each other very well. Therefore, to expect that the information management system of a particular hospital will be able to feed easily into the Canada Vigilance reporting system could prove to be quite a challenge.
Mr. Tholl: First, I agree with the last point. We haven't been vigilant enough in ensuring conforming standards across and between institutions, but that is a larger debate around Canada Health Infoway and what we need to do on that front.
With respect to Accreditation Canada, I would add that it does define health care facilities pretty broadly. It's not just hospitals; it does include health care centres, community health centres and those kinds of things. Again, start with that base.
Senator Eggleton: And pharmacies, as well?
Mr. Tholl: No.
Ms. Cooper: No.
Mr. Tholl: I would like to add one other point. I'm an economist by training. Can we apply a cost-benefit analysis? If we are to step up the reporting requirements, can we make sure we're getting the kinds of benefits relative to the administrative costs and direct costs — and there are direct costs as well as indirect costs. It is lost time. Those two hours that the practitioner spends trying to pour over whether it's a reportable incident or not are two hours taken out of time they are spending with their patients. There are tangible costs and intangible costs.
Senator Eggleton: Should pharmaceutical companies be responsible for conducting post-market surveillance activities or should that be a third party responsibility? Do any of you have comments on that? If you don't, I will pass on to the next question.
Ms. Cooper: Yes, they should be responsible for doing that, but there is also a role for a third party to be doing it, as well.
Senator Eggleton: It needs some oversight, maybe?
Ms. Cooper: Yes, to be monitoring it, because we have seen incidents where it has not been well reported.
Mr. Tholl: ''When necessary.'' I am thinking of the approval of tPA for off-label use for stroke attacks 15 years ago as opposed to heart attacks, where there wasn't another available treatment at that time for strokes. I was at the Heart and Stroke Foundation at the time where we had stepped up post-market surveillance because there was no other appropriate available treatment.
Those are instances where the industry has an absolute obligation to step up to the plate and do post-market surveillance.
Senator Eggleton: One of our presenters last week said that we should change the definition of ''medical device'' as defined under paragraph 2(1)(b) from anything used in modifying a body structure to anything used to promote health, such as sterilizing equipment like autoclaves, ultraviolent lamps, ethylene oxide sterilizers and non-physical aspects of medical devices like software used to operate items such as an insulin pump or a pacemaker; unregulated, unsafe software can kill you the same as unsafe hardware.
Do you have any thoughts about this subject?
Mr. Tholl: I am told there are over 2,000 new medical devices introduced in Canada every year. Less than 10 per cent are subjected to pre-market review.
Senator Eggleton: Less than 10 per cent?
Mr. Tholl: Yes, and that is all Schedule 5, so we are thinking implantable devices at the one end.
We need to think about doing for devices what we've done for drugs in terms of the common drug review. I believe the Canada's agency for drugs and therapeutics is just beginning to initiate a process to do for devices what we've been doing for drugs; namely, to get a finer distinction between what should be and should not be subject to premarket surveillance. I know that because I'm on an advisory group with them.
Senator Seth: Thank you for your presentations. They were very interesting.
In your presentation, you said that the term ''prescribed health care institutions'' is not clearly defined in Bill C-17. Could you please define it and where you think it should be in Bill C-17? What is the ''prescribed health care'' definition?
Ms. Cooper: I don't think we can actually define it, because even for us, there are a lot of ''ifs.'' Health care is evolving, as is health care delivery and moving away from family health clinics and those types of things. I believe that this will have to be in the regulations because then they can be changed as health care evolves. It will be really important as the regulations are developed that the key players are consulted in getting those details.
The definition of a prescribed institution is obviously going to include our major hospitals, but at this point we would not think it would include community pharmacies. That's not to say that we don't think community pharmacists should be reporting, but their data collection and mandatory reporting would be the challenge. We certainly encourage them to report. They need to report. They are seeing these things, as well as front-line family doctors and nurse practitioners, but not to be in that definition. I don't think it could be spelled out in the act as it is. It's a regulations issue.
Ms. Roy: Again, from previous consultations that I participated in, it's my understanding, as Janet just mentioned, that ''prescribed'' health care institutions for the purpose of this act will be hospitals. In hospitals where Sentinel reactions have been reported, these prescribed institutions will be asked to report more information, to add information to what's available already and to try and connect a particular drug — because the wording in the act is clear; it's ''a'' particular drug — to a given or ''prescribed'' adverse reaction.
Senator Seth: Okay, but don't you think it's very important to define here that we are supposed to report these adverse reactions? This is quite a base for this bill.
You have presented as well that Bill C-17 does not give a clear definition of ''serious'' adverse drug reactions, and that it is very important to have a clear definition of ''serious'' because practitioners deal with serious situations every day. How do you define ''serious'' in this context?
Mr. Eisenschmid: My answer is also an answer to your previous question. There's a bit of a chicken and egg in the way it was drafted in that what would be a prescribed institution correlates highly with what a serious adverse condition is and the extent of the reporting. Depending on how you define each one of those elements, they help to define one another.
In terms of serious, as I said in my report, there are lots of adverse conditions that are well-known and well documented but maybe not well reported right now, at least not in highly usable form. But in my mind, ''serious'' is something that is new or incremental value-added information; it's something that hasn't been reported before. Clearly, many things have serious health consequences, but in my mind additional reporting is not required unless it's actually something new that isn't already well understood and well-known. That would be my interpretation.
Ms. Roy: Pharmacists have been using a definition of ''serious'' adverse drug reactions for years, and there is a definition provided by Health Canada and the MedEffect program for ''serious'' adverse drug reactions. I guess what's not clear here is if we will be using the same definition that exists right now. ''Serious'' adverse drug reactions right now are defined as any reaction that would bring a patient to the emergency room, lead to a hospitalization, to death or to an extended hospital stay. I'm paraphrasing. That's my recollection of the definition of ''serious'' adverse drug reactions. I would hope the definition that will apply to this act and will be defined in the regulations will be similar to that.
Senator Enverga: Thank you for the presentation. This is more of a follow-up about the recommendation on natural health products.
As far as I can remember, when I get a prescription, it says do not drink any grapefruit and do not take any calcium. You mentioned that ginseng can reduce the effects of warfarin. Is there a label like that, ''Do not take ginseng products''?
Those are things that pharmacists have been doing. Don't you think it's enough to warn the patients of the complications that could arise through using these other products instead of putting labels on the natural health products? There are so many different forms of natural health products. It could be natural and it could be the regular ones. Don't you think it's enough, instead of including it, and that we're doing the good things already?
Ms. Cooper: I wasn't aware that the Natural Health Products Regulations would be addressing some of these same things. My concern is that there need to be similar penalties and powers of the minister if there are real concerns with some of the natural health products that are out there, and penalties on the manufacturers.
In terms of pharmacy labels or information, some of it is not even known, so it's not going to be on labels. There are some adverse interactions that would be known. That's another whole area with the information that people are getting. The information they're getting out of their pharmacies often comes from American content suppliers. We've discussed a lot with Health Canada the importance of having Canadian information available through the software systems, be they pharmacists or physicians, and available like that.
I still think we need to be looking at it. Hopefully it will be addressed when NHPs are being looked at, that there will be serious consequences if there are unsafe activities, and that the minister can be requesting further studies and reports because these drugs are not all safe.
Ms. Roy: To reinforce what Janet has said, there's still so much misconception and misunderstanding of natural health products by the public. ''Natural,'' as was mentioned by Perry in his intervention, is sometimes understood as being without risk, which is, we know as health care professionals, not the case.
I'm a hospital pharmacist by training and by experience. I remember one discussion I had with a patient. I can't remember exactly what we were discussing, but she said, ''It's a natural health product.'' My answer to her, and it really stunned her, was that there are plants that can kill you. She was just stunned. She never thought of that.
To your point, senator, about just putting a label on a bottle — and, furthermore, natural health products are purchased off the shelf — most of the time the pharmacist doesn't know the patient is taking those products.
Mr. Eisenschmid: Similar to the point I made earlier, when you've got a highly regulated substance like pharmaceuticals versus something that is less regulated, these things are moving at different speeds and directions. You can have natural health products coming on the marketplace that aren't well understood in terms of the indoctrination products that come with pharmaceuticals. So to think that for every natural health product we're going to capture and have a drug interaction with a pharmaceutical product isn't going to necessarily happen if you have looser rules around the initiation and creation of natural health products.
Senator Enverga: In this regard, I know that right now big pharmacies are selling natural health products. Do you think that it would be safer to buy there rather than from outside, other outlets?
The Chair: I think the question is: Is it safer to buy it from a pharmacist than off the shelf in a regular type of store?
Ms. Cooper: If the consumer comes in and they just buy it and go to the front checkout, it's no safer to buy it from a pharmacy. If they actually go to the pharmacist and say, ''I want to buy this; can you talk to me about it, and I'm also on these medications,'' the pharmacist is going to be able to determine what the risk might be, if there are potential interactions with other medications or other medical conditions.
Senator Enverga: But will it be the duty of the pharmacist — let's say you're paying for it — to ask if you are taking medicines, to forewarn the consumers about that?
Ms. Cooper: Yes, pharmacists should be doing that, but often they would not have that opportunity to interact with the patient, the consumer. when they come in because they go in, buy it and walk out.
Mr. Eisenschmid: Part of that deals with the regulation of those products if they're behind the counter, in front of the counter. The pharmacist has the responsibility behind the counter. If things are in the retail section, the front of the counter, there's no pharmacist at the front checkout for the groceries or the chocolate bars.
Senator Enverga: It would be like buying medicines over the counter.
Mr. Eisenschmid: If it's regulated as such, yes, it would be.
Senator Cordy: Thank you very much for appearing before us today.
I was struck by your comments related to the burden on an already stressed health care system. We know that there were significant cutbacks in Health Canada, for example, so if we talk about getting the information out and we've had cutbacks and this bill provides for more information to Canadians, then how is that going to work? I wonder if you could just go over that.
I know the ultimate goal of this bill and that our committee certainly has been saying in our recent reports that Canadians have to have the information when they're buying pharmaceuticals. They have to know the side effects and the benefits and then, as consumers, weigh whether or not they want to take it.
Canadians also want to know whether or not there are adverse drug reactions that they weren't aware of.
Some of you mentioned these things when you were speaking: the manner of reporting and how are we going to get that information in a timely way. Timeliness was something else that you spoke about.
Who should be responsible for reporting on critical incidents? I think, Mr. Tholl, you spoke about some of the people that you work with saying you get all this information and all the reports to Health Canada, but then they never see the light of day. You also talked about computers not talking to one another, not being able to communicate. We had a witness before us in one of our studies who said even within the same hospital you couldn't get information from one department to another, so how are we going to ensure that information is going to get from a hospital in Toronto to Health Canada to the general public or from a pharmacy to wherever?
Everybody who has appeared before us has said that they agree with the bill. I certainly agree with the whole premise behind the bill, but is it workable and how can we make it workable? That would be my question.
Mr. Eisenschmid: As we mentioned before, there are mechanisms to report adverse drug reactions. I'm reassured that there are some initiatives under way in Health Canada right now, and we're in exploratory discussions with them around Part III, patient safety information upon the dispensing of drugs. So if that adverse drug reaction information can be included in the safety information that can go along with dispensed information but, more important, can be written in a way that is user-friendly, that the general public can read and understand, that would go a long way toward effective implementation of whatever adverse conditions are being reported. That is a critical implementation step that I'm reassured seems to be under way and we seem to be able to participate with Health Canada in making it happen; but, it is developing slowly, and any acceleration on that front would be beneficial.
Mr. Tholl: I have two very quick points. In terms of the system in distress and under pressure, we're in the third year I believe of negative real growth in total health care spending. I'm the finance and audit chair at the Royal Ottawa Hospital. We're in the fourth year of zero means zero, which means minus 0.7, minus 2 because employment contracts are continuing on.
To expect Canadian health care facilities to step up and spend more money on IT systems to service this bill is going to be very difficult. So we're hoping that there's going to be some money that goes along with this, whether it's funneled through Canada Health Infoway or some other mechanisms to help us do what the bill is asking us to do.
My last point would be this: My hope would be that this kind of compelling reason to step up our game in terms of adverse reporting might actually pull the rest of the IT systems along with it so we can move to 100 per cent e-prescribing across Canada, for example. I think we only have it in one province now, Quebec. Is that true?
Ms. Cooper: Yes.
Mr. Tholl: Why don't we have e-prescribing right across this country? That would then prevent a lot of things as opposed to put the horses back in the barn after they've gone.
I hope that answers your question.
The Chair: Mr. Tholl, we've been asking that question for three years now in many different dimensions and directions. All I'm saying is, we understand entirely and we have been demanding it on an urgent basis.
Ms. Cooper: To add to that, there has to be an investment in drug therapeutic information database that can be a centralized repository that physicians, EMRs, pharmacy software systems, hospital systems can be drawing from Canadian data that has safety information as well. How are pharmacies getting their information on safety? It all comes in through their fax machines with everything else, and it's often sitting over in the post office area of the pharmacy. For physicians, it comes in through the fax. There is all kinds of promo stuff coming in about new products, so it gets missed.
There was a big fax this morning about safety concerns that came to us as an organization. It's important to get that information out there in bullet-sized chunks that practitioners and patients can actually use and put together, because the databases now in pharmacies and a lot of them in physicians' systems are either a giant list of all the drugs in the Canadian database — so you have 100 times one product come up because it's every different DIN that's out there — or it's coming from American sources. There has to be an investment in some really good, accessible Canadian information that can pull the treatment, which drug and how to use it and which patients, as well as all the new safety information that also has consumer language information there.
Ms. Roy: Senator Cordy, I'm glad raised the issue of the burden also on Health Canada, once all this information is coming to them, because that's certainly a concern. We raised it back in 2008 when I spoke to the Standing Committee on Health about the mandatory reporting of adverse drug reactions by hospitals, that there's a need to clearly define ''serious'' adverse drug reactions. At the time it was ''all'' serious adverse drug reactions; it was not ''a'' serious adverse drug reaction.
As Perry mentioned in his intervention, is there a need to report every single serious adverse drug reaction if we already know them very well? Therefore, that would reduce the burden on both Health Canada and health care practitioners.
I think the issue raised by the Canadian Pharmacists Association, facilitating the reporting with point-of-care systems with apps that health care practitioners could take with them to the bedside, would also improve reporting. Right now you have to report through a PC to the Canada Vigilance database, and although there have been improvements — I want to acknowledge there have been improvements in the database — it's still very difficult to navigate. It used to be that you could only search the database by drugs, so it was very difficult if you had a reaction to try to narrow down which drug actually might have caused this reaction. You could not search the database the other way. That has been added. You can now search by reaction, but it's still very difficult to navigate the database.
Once we collect all this information, if it's done through whatever route we use, information management systems, whatever is collected needs to get back to health care practitioners, professionals, in a timely fashion so that they can start preventing further adverse reactions from the drug.
[Translation]
Senator Chaput: Ms. Roy, I would like some more information on the definition pharmacists use for certain drugs. I believe you said that pharmacists have their own definition of serious health risks or adverse reactions associated with certain drugs. Do pharmacists have such a definition?
Ms. Roy: We use Health Canada's definition.
Senator Chaput: The same one, then.
Ms. Roy: It is Health Canada's definition. What is a ''serious adverse drug reaction''? It is a reaction that requires hospitalization, prolongs existing hospitalization or results in death. I believe those are the three main elements that define a ''serious adverse drug reaction''.
Senator Chaput: You are hoping that that definition will be used for the purpose of implementing the bill?
Ms. Roy: Yes, and that the definition could perhaps be clarified. As briefly mentioned in the Canadian Pharmacists Association's presentation, some serious adverse reactions within the scope of the definition are already well-known.
For instance, I touched on warfarin in my presentation. If a patient on warfarin experiences serious bleeding and, as a result, has to be hospitalized for a prolonged period or is at risk of dying, that situation fits the definition, but we know that warfarin can cause bleeding. Knowing that another patient has had such a reaction will not improve patient care.
Chemotherapy is another good example of a treatment that, after being administered, is known to cause serious adverse reactions, such as immunosuppression, which, once again, can lead to effects that are consistent with the definition. We know, however, that those reactions are possible, and it does not stop chemotherapy from being used because the benefits outweigh the drawbacks.
Senator Chaput: Are you aware of other definitions that are used in other countries?
Ms. Roy: I am not aware. What the Canadian Society of Hospital Pharmacists is proposing, and this was also touched on by the Canadian Pharmacists Association in its presentation, is the reporting of ''new'' serious adverse reactions to ''existing'' drugs, so that means serious adverse reactions that are unreported or under-reported, as well as ''all'' serious adverse reactions to ''new'' drugs. Such a practice would more clearly highlight the types of reactions where reporting would benefit Canadians' health.
Senator Chaput: Would any of the other witnesses care to comment on that?
[English]
The Chair: Thank you very much, witnesses. There are some themes that have come up here today that have arisen in part before and certainly issues that we will want to get clarity on with regard to officials and their intentions with regard to definitions, which are obviously critical in moving the bill forward. The regulations will be essential with regard to interpreting the bill. You've correctly put on the table the issues you identify.
I must say, I'm a little relieved as chair of the committee that natural health products aren't included in this revision this time. It has taken 50 years to get here, and based on the emails I've received with regard to natural health products, I would suggest it would be another 50 before we get out from some of those issues.
Nevertheless, I am very hopeful that issues will come forward with regard to those that make health claims or for which there is the identification of interaction with prescription pharmaceuticals. These are critical issues, and very hopefully Senator Seidman's thoughts on this will come forward in the future. I think we all share her hope that these things will come forward in the near future because they are referred to within the general act in terms of medicines and so on.
Mr. Eisenschmid, I was struck by your comment — and I understood completely as you said it — with regard to limiting adverse reactions to those that are under-reported. Under-reporting seems to be the theme with regard to adverse reactions, and our studies indicate that less than 3 per cent of all adverse reactions are studied. In fact, it's likely well under 1 per cent of all adverse reactions are reported. I thought if we start putting something out there that suggests to that audience that they only have to report serious adverse reactions that are under-reported, I think we will limit that even further, but your point is very well taken with regard to those issues.
On the other hand, adverse reporting in a broader sense is, from our point of view, essential because of the high degree of off-label use of medications and, therefore, the application of medicines in subsets of the population that were not included in any clinical trial as it went forward. As pharmacists, you need to deal with those populations, which are largely children, certainly pregnant women, but women to some general degree, and the elderly. So this issue is a concern.
The idea of having an electronic system that will get us to universal e-health records is one we have been pushing and hammering hard on in this committee for over three years now. With respect to your reference to Canada Health Infoway, we hope they are making progress, but we know the amount of money that has been poured into those systems which have not led, in general, to national systems of importance. In fact, we have recognized that certain organizations, such as the pharmacists association, have been very advanced with regard to your own development of information systems. We have, indeed, used you as examples of how systems can actually work across provinces. So we are very hopeful that your commentaries and our reports will encourage much more focused activity in these areas in the future because they are essential to any health legislation. It's the information that is critical.
On that note, I want to thank you for the thoughtfulness of your comments here today and for being here with us on this bill, and I want to thank my colleagues for their questions.
I am now pleased to welcome to this session, from The College of Family Physicians of Canada, Dr. Jamie Meuser, Executive Director, Continuing Professional Development and Practice Support; and we have back with us, but he has escaped the continent this time, from Canadian Institutes of Health Research, Dr. Robert Peterson, Executive Director, Drug Safety and Effectiveness Network. We are delighted to have you both with us.
Perhaps because of the distance that he has travelled to get away from us, I will get Dr. Peterson on the record first so he doesn't escape us any further. Dr. Peterson, would you please present to us?
Dr. Robert Peterson, Executive Director, Drug Safety and Effectiveness Network, Canadian Institutes of Health Research: Thank you, Mr. Chair. I would also like to thank the committee for inviting me to speak to you about Vanessa's Law and the Canadian regulatory framework related to prescription pharmaceuticals.
As the committee is aware, the Drug Safety and Effectiveness Network, or DSEN, is a national network now comprised of nearly 200 researchers that provides evidence on drug safety and effectiveness to regulators, policy-makers, health care providers and patients. First, let me acknowledge that Canada currently has a robust legislative and regulatory framework when it comes to assessing the safety, efficacy and product quality before a new drug is authorized on the market.
However, the consensus among experts is that Canada's post-market, legislative and regulatory oversight of drugs has fallen behind international jurisdictions to which we often compare ourselves, in particular the United States and member nations of the European Union.
Current areas of weakness include, for example, the minister's authority to compel studies when safety is unproven in populations outside those studied for market authorization; the minister's authority to require changes to the product monograph when new information is brought to the attention of Health Canada; and the minister's authority to compel public disclosure of safety concerns, even when they have yet to be proven.
Bill C-17 presents, in my mind, a great opportunity to fill these gaps and to provide Health Canada and the Minister of Health with the tools and authorities necessary to strengthen safety oversight of therapeutic products throughout their life cycle and to take appropriate action when a serious risk to health is identified.
An area of importance related to this bill is the minister's ability to disclose information submitted to Health Canada that is not deemed to be a trade secret but that has been considered confidential by the manufacturer. Thus, the transparency paragraphs in Bill C-17 are essential to respond to the current expectations of governments, government agencies, health professionals and the general public in terms of informing them of potential harms of prescription pharmaceuticals.
Bill C-17 speaks to issues of therapeutic product safety and injury stemming from marketed use of such products, and it enhances the Minister of Health's ability to require post-market tests or studies on the safety and efficacy of therapeutic products.
While Vanessa's Law does not specify authorities that would compel demonstration of comparative benefits, the bill is expected to indirectly permit a life cycle approach to the benefit-to-harm pre-file assessment of marketed products, and this is key to ensuring that patients receive the best treatment available in Canada.
As with many prior amendments to the Food and Drugs Act, the language in Bill C-17 is high level in defining new authorities for the Minister of Health. Details as to how these authorities will be exercised are to be found in the regulations that will accompany the act. It is at the level of regulations that, for example, specific requirements for subpopulations such as children, pregnant women, Aboriginal peoples and the elderly are expected to be defined, and it will be the department responsible for developing and enforcing those regulations.
As you heard during the committee's study on prescription pharmaceuticals, DSEN has created a successful research infrastructure that undertakes high-quality, post-market assessment of the studies that the Government of Canada will, in fact, compel under this component of Vanessa's Law. I believe that DSEN's infrastructure will serve Health Canada and the Minister of Health well as it accustoms itself to the new provisions in Bill C-17.
In conclusion, as Director of DSEN, I firmly believe that Vanessa's Law is an important step in the enhancement of post-market surveillance of prescription pharmaceuticals.
Thank you for permitting these introductory comments, and I will endeavour to concisely answer any of your questions.
The Chair: Thank you, Dr. Peterson. I will confess that the real reason for getting you on first is the possibility of the vagaries of technology, so I wanted to get your testimony in for sure. We will get back to you with questions, we hope.
Now I will now turn to Dr. Meuser, please
Dr. Jamie Meuser, Executive Director, Continuing Professional Development and Practice Support, The College of Family Physicians of Canada: Good morning to you, members of the Standing Senate Committee on Social Affairs, Science and Technology, and to you, Mr. Chair.
As the Executive Director of The College of Family Physicians of Canada and as a practicing family physician, I am privileged to be here with you today, and I thank you for your invitation on behalf of myself, the college and its members.
The College of Family Physicians of Canada, The CFPC, is the voice of family medicine in Canada representing over 30,000 members. The CFPC advocates on behalf of its members to ensure high quality in the delivery of care, but education is the key element of our mandate. We establish standards for the training, certification and ongoing education of family physicians. We are also responsible for accrediting postgraduate family medicine training in Canada's 17 medical schools.
I would like to start by commending the government for introducing Bill C-17, the ''Protecting Canadians from Unsafe Drugs Act,'' or Vanessa's Law. The CFPC welcomes the power given to the federal government to recall unsafe products, as well as requiring adverse drug reaction reporting by health care institutions. We support the proposed penalties for unsafe products, which includes jail time and fines up to $5 million a day. Measures like this demonstrate that the continued release of unsafe drugs in Canada is completely unacceptable.
Some amendments to Bill C-17 seem to provide additional patient safety assurance. For example, requiring that both positive and negative decisions about drug authorizations are disclosed on a public website and requiring clinical trial information to be disclosed on a public registry will open this information to the public. We certainly shouldn't need the USFDA to shine a light on this crucial information.
These amendments, as we see them, will help improve transparency through various means, including ensuring that patients, clinicians and researchers can access critical drug safety information. As family physicians, we need to be confident that we have the most comprehensive information when we prescribe a medication to our patients. This is why it is crucial that a better system for communicating the risks associated with specific drugs is provided to health care professionals and to the public, and that means our patients.
While we applaud these patient safety measures, CFPC would also like to ensure that the information being released to the public is not only thorough and comprehensive but also timely. If a drug's safety is ever questioned, Health Canada needs to communicate this information to the public immediately. It is concerning that certain pharmaceutical companies have been allowed to continue to sell their products even after it was known their products were defective.
In addition to the recent news about Apotex, we experienced an unfortunate event last year with faulty birth control packages reaching consumers in Canada. This represented a breach of immense proportions to the care of women, and it eroded the public's confidence in the drugs being prescribed to them. A Class I recall was not issued by Health Canada until six days after the pharmaceutical company, Apotex, was aware of their product deficiency. Had these women who were prescribed that drug by one of our 30,000 members been notified immediately of the product deficiency, they and their physician could have taken the appropriate action needed, such as backup methods of contraception or the use of an emergency contraceptive method.
Let me just underscore this point: The immediate release of public notification about glitches in the drug stream is crucial. It is crucial to patients and to prescribers.
Just as the timeliness of information released is important, an increased level of transparency will also fortify accountability and further enhance Health Canada's efforts toward patient safety.
As noted in the 2011 Auditor General's report, Health Canada's decision-making process currently lacks transparency. Health Canada publishes very limited information on drugs and high-risk medical devices when a Notice of Compliance is applied for. The public does not get to find out why Health Canada did not allow a drug a Notice of Compliance. The public and prescribers have a right to be informed of the reasons why Health Canada has given a certain drug a Notice of Compliance and not others.
Adverse drug reactions have detrimental effects on patients, including death. Currently, Health Canada's adverse drug reaction database is voluntary, which is leading inevitably to under-reporting. By introducing stricter requirements for adverse drug reaction reporting, Health Canada will ensure that the side effects that patients experience are more likely to be brought to the attention of Health Canada.
In a society where knowledge is power, it's important that all health care professionals are given the most comprehensive and transparent information regarding the drugs and medical devices they prescribe to their patients. We should be able to feel confident that we're making the most informed decision on behalf of our patients and feel secure that we are protecting our patients from any harm.
The CFPC welcomes laws that seek to improve the health of Canadians, and we thank you for your leadership on Bill C-17.
The Chair: I will now open up the floor to my colleagues and remind them that this meeting will end no later than 12:30. I will start with Senator Seidman, the sponsor of the bill in the Senate.
Senator Seidman: Thank you both very much for your presentations.
Dr. Peterson, I wish to prevail upon you because you have made interesting points in your presentation to us. In fact, I don't know if you were able to hear the testimony we had yesterday from the pharmaceutical industry specifically regarding a point you refer to here. That had to do with the disclosure of what they call ''confidential business information.'' You say here that transparency is essential to respond to the current expectations of governments, government agencies, health professionals and the general public in terms of informing them of the potential harms of prescription pharmaceuticals.
What we heard yesterday about this disclosure of confidential business information is that pharma expected ''advise'' and then ''consent'' in the approach to releasing this business information. They said that this was a potentially serious abrogation of NAFTA and isn't in conformity with the European Union and the U.S. How would you respond to that given what you put forward to us today?
Dr. Peterson: Unfortunately, I did not hear the testimony yesterday and I've not seen the transcript of that. However, you have presented the position that I have heard before from that sector and done so clearly. I do disagree with it.
There is an obligation that Canada has under international trade agreements to hold confidential what is considered to be trade secrets. I believe that the language in the act, as we see it currently written, does provide good discretion on the part of the minister to take decisions as to what is necessary as far as transparency and disclosure in order to protect the health of Canadians and to prevent injury.
It will be certainly important for the department, as it goes into regulations, to clarify exactly what the tests will be in order to determine and differentiate a trade secret from what companies have, in the past, held as confidential business information.
I believe — and this is based on the experience of having been within the regulatory branch looking at that information — that there quite honestly is little beyond the chemistry and manufacturing of how these products are produced that could be considered to be a trade secret. The information developed within clinical trials, the information discussed with the regulator with regard to the rationale for why a product monograph would contain certain language, is something that should be transparent. We've already seen and have heard from many representations before the committee in its previous study the importance and relevance of having access to the data used in the clinical trial application for the product licensing and how important that information is to many in the Canadian population — not only health professionals but other government agencies.
I'm afraid that I must disagree with our colleagues from the industry on that point.
Senator Seidman: I really do appreciate your clarification, especially coming from someone who has all this experience as head of the Drug Safety and Effectiveness Network.
Are you saying that you feel these issues can be dealt with in regulation?
Dr. Peterson: I do. I have read this carefully and have reviewed it with the individuals within department who drafted this, and I believe that it is enabling of regulations. It is enabling to the extent that it provides discretion on the part of the minister to protect health from injury but also allows for that discretion to be exercised with regard to our international treaties on trade secrets.
Senator Seidman: The other pressing issue that I would like to ask you about, and you also referred to this at the end of your presentation today, concerns Health Canada's resources. We keep hearing a lot about Health Canada's capacity to carry out Bill C-17. They're already overburdened. We hear reference to reduction in funding and various things.
Since you talk about DSEN's infrastructure and how it serves Health Canada and how it will play a primary role in looking at some of the issues, the adverse reactions and deal with the impact of Bill C-17, I would appreciate what you might have to say about the capacity of the department to deal with this.
Dr. Peterson: Again, I have been away from my position at Health Canada for some time, so I'm not currently aware of the details of their resources. However, it is clear that this bill, the amendment to the act, provides for many new authorities on the part of the minister to compel actions that will result in the submission of additional information from the companies that the department simply has not had before.
I would not at all be surprised if that would carry with it a very strong requirement for additional resources within both the Marketed Health Products Directorate and conceivably in the pre-market assessment groups as they hand over what their review of the pre-market data is to the post-market group in order for the discussion as to further post-market responsibilities on the part of the manufacturers to be clear.
The Drug Safety and Effectiveness Network resides as an independent source of evidence for the department. As such, I would envision that the minister will compel studies on the part of manufacturers. The opportunity for the minister to also turn to the Drug Safety and Effectiveness Network in order to review and perhaps provide an independent assessment of that information based on the methodology that we can bring to bear within Canada, I believe, will be an essential component to the success of this.
Senator Seidman: Thank you, that's very helpful.
Senator Eggleton: Dr. Peterson, I'd like to get a little further into this confidential business information, particularly the trade secret end of things.
How do you separate trade secrets from the confidential business information and still provide meaningful information that helps people determine what is going on in terms of this drug? You seem to suggest in your submission that it can be separated out somehow. I don't know what that leaves. I am not sure what other confidential business information there is that doesn't involve trade secrets. Could you clarify that for me, please?
Dr. Peterson: I will give you my opinion on this, senator. I believe that there will be better experts than me who you might need to prevail upon in order to make that distinction. However, I look upon a trade secret as related to that information that the company utilizes in the production of their products, the information associated with how the chemistry and manufacturing takes place and how the product is prepared to bring to market.
Beyond that, I see very little that should be considered a trade secret. What has been referred to as ''confidential business information,'' I am challenging whether that is indeed confidential from the perspective of the minister.
Certainly, there are competitive advantages to companies if their submissions to government are not made public. That competitive advantage might be to another manufacturer who may now learn some information that they were not aware of and could either accelerate or slow down their movement in a competitor product.
The reality is, however, that a good deal of the information that the minister has been asked not to disclose in correspondence with manufacturers can either be found on their investment website portfolios to provide information to their investors or, as has already been submitted both here and in the United States, on Internet websites.
Senator Eggleton: If the minister decides to recall and decides that the disclosure of confidential business information is appropriate, do you think she — or he, looking into the future, whoever the minister is — can do that without disclosing a trade secret?
Dr. Peterson: I believe so, yes. I don't believe that it is considered a trade secret that there has been a safety issue identified with a product on the Canadian market. I believe that the companies would prefer that that be held in confidence and that the minister would discuss those issues just with the company. I do not doubt that that will happen as well. As part of that discussion, I would assume stemming from the new authorities in this act, the minister would be informing the companies that she would be releasing the information associated with the recall publicly.
Senator Eggleton: Let me turn to Dr. Meuser. You made the point that the disclosure of information or the action being taken by Health Canada needs to be timely. This is one of your greatest concerns. In fact, you said, ''Let me just underscore this point: The immediate release of public notification . . . is crucial.'' Would you see that being dealt with in the regulations, or is that something that needs to be clarified in this act?
Dr. Meuser: I guess I'm the doctor and you're the lawmaker: Whatever it takes to make sure that it happens.
Senator Eggleton: Fair enough.
Dr. Meuser: I think about the physicians who prescribed something to those patients during the six days between the time it was known, the time it was revealed and the potential for harm built into that. That is something those physicians and the system have to live with. So, however it has to happen, that is how it has to happen.
Senator Eggleton: Let me ask both of you this. The act authorizes the minister to order the holder of a therapeutic product authorization to conduct an assessment of the therapeutic product to which the authorization relates. Should the pharmaceutical companies be responsible for conducting post-market surveillance activities, or should this be the responsibility of a third party, or should there be some oversight of a third party?
Dr. Meuser: I personally don't see that as either/or; I see it as both/and. There certainly needs to be post-market surveillance by any pharmaceutical organization or other drug or device supplier that introduces their product on to the market.
In addition, in order to ensure that there is public and prescriber confidence in the system, there needs to be an audit at the very least, but I think certainly a capacity to be at least as rigorous as we require in post-market surveillance to ensure that both efficacy and safety are what was imagined at the beginning.
Dr. Peterson: I concur with that. The authority that the minister presently has is to compel the manufacturers to report adverse reactions both within clinical trials and during the post-market environment. The bill extends that authority to require health care institutions to require their submission of adverse drug reactions as well.
The passive reporting system that exists in Canada and in many other countries in other environments has been augmented by more active surveillance systems; that is, by real-time evaluation of events as they accrue into health records or administrative health records. We have taken a number of steps in Canada, as you know, with the Drug Safety and Effectiveness Network to gain access to administrative health records across the country. We also have methodology and research teams that have been identified and established in order to conduct active surveillance activities.
I believe that this is a responsibility of manufacturers that cannot be relinquished to another sector, but I also believe that in the interest of multiple checks on a safety issue, the government should have the authority to compel more additional studies than just what a surveillance reporting system would be. If a signal is identified in the passive reporting system, it is not unrealistic for the Minister of Health in Canada to do what her counterparts in either Europe or the United States currently have the authority to do; that is, to direct the market authorization holder to provide evidence that that safety signal is not a serious concern to the minister.
In addition, I believe that our program at the Drug Safety and Effectiveness Network can certainly provide independent confirmation of safety signals. The methodology moves well beyond what we are presently seeing the minister have authority for.
Senator Eggleton: Thank you. Some of our previous witnesses have suggested that it may be too fast going to a recall and that it is a very heavy tool; a sledgehammer — someone else called it a nuclear option. Perhaps it might be a graduated option and there might be suspension to start with before you go to recall — that is, suspension helping to protect the public while more work is being done to determine whether a full recall is necessary.
There is provision, I understand, in the Food and Drugs Act, or in the regulations, for suspension, but it is not necessarily coordinated through Bill C-17, which relates to the recall provision. What are your thoughts about this kind of graduated system idea? This is for both of you.
Dr. Peterson: This bill actually covers medical devices as well as drugs. In my experience, recalls have been perhaps more of an issue with a medical device that has failed or for which there serious adverse events have been reported. However, in recent weeks we have seen that recalls of medications have been required as well.
I believe that the discretion on the part of the minister that is provided within the current wording of the bill allows for a judicious and appropriate use of an order of recall. For those conditions that are immediately life threatening, the recall can be made quite immediately. For those conditions that allow for a staged approach which would involve informing pharmacies, healthcare providers and patients, that might not be unrealistic.
I do favour the authority for the minister to be able to issue an immediate recall if the threat to health sufficiently warrants that.
Dr. Meuser: The problem with this decision, as with many in clinical life, is that you don't know at the beginning of the process how serious the signals are and, therefore, how serious the reaction needs to be.
Given that, one sensible mode of action that may be worth considering — but clearly it is all going to be in the judgment of the minister and her staff — is treating everything at the beginning as if it's as serious as it possibly could be. That's certainly the decision that would be most in keeping with patient safety.
There are obvious difficulties with that. I agree with Dr. Peterson. For drugs, a suspension is virtually equivalent to a recall. As long as we have information and our patients have information that, tomorrow morning, you don't do what you did yesterday morning or this morning, that's important. In fact, allowing us to have that kind of critical information early and quickly allows us now, with automated prescribing, to identify which of our patients need to know about it. That becomes much more intentional.
Family doctors don't tend to be as involved with medical devices as we are with drugs, so I would certainly defer to Dr. Peterson's opinion on devices.
Senator Enverga: Thank you for the presentation, gentlemen.
We learned a lot of things today. As far as I understand it, doctors depend, to a large extent, on the various databases of pharmaceutical agents when deciding which drug to prescribe a patient. It used to be the Blue Book in many offices before the electronic era. I assume that interactions between drugs are included in them.
How do these databases update their information and warnings from Health Canada, and how long does it usually take to have new patterns of adverse effects included?
Dr. Meuser: To my knowledge, the paper books that we used to use, the CPS and similar ones, are populated with information supplied by the manufacturer of the drug. Like any paper document, they're static. They supply whatever information you need when you need it, but that information may have been put in there at the time the drug was introduced or at subsequent publications of that resource. Probably the most commonly used resource in our world would be the paper CPS and electronic versions as well, which are much easier to update.
I should say that one of the resources we've had in the last decade, and particularly the last three to five years, to make these kinds of calls, to acquire additional information, is our patients. That is why it's so particularly important that public information is as available as prescriber information. We count on our patients, in many ways these days, to bring us information that we didn't have. In fact, one of our new functions within family medicine is to be high-quality curators of health information that our patients bring to us. It's not always wonderful information that they bring to us, as it varies in quality, but we are now beginning to be able to count on our patients as purveyors of information about clinical decision making to us and for us for their care.
Dr. Peterson: I concur. We are moving away from a static, paper-based system into electronic sources of information that are readily available on desktop computers and on portable handheld devices that can be updated regularly.
More important to me is the information that has been sent out by virtue of ''Dear health care provider'' letters that in the past the minister has had to request the pharmaceutical company to provide. It often becomes somewhat of a negotiation that takes place along those lines. Ultimately, the minister can issue the letter herself, but the responsibility for this truly is on the market authorization holder. At this point in time, within the provisions of Bill C-17, you would see a large change take place, where the minister would be able to compel the issuance of a ''Dear health care provider'' letter to health professionals.
I must say that, for a number of years, that ''Dear health care provider'' letter has been accompanied by a public notice of disclosure.
The information in the ''Dear health care provider'' letter is somewhat technical. It is intended to provide practitioners with the basis of the concern and, perhaps, some appropriate actions for them to take.
The purpose of the public disclosure is to provide a very broad notice such that any individual who may have been prescribed the product of note in this public disclosure is encouraged to contact their health care provider in order to determine whether or not the information that has been recently sent to them will have an impact on their health.
Once again, I believe that there would be authority on the part of the minister, according to the wording that we see in this act, to compel that public disclosure on the part of the manufacturer or to do so herself.
Senator Enverga: Okay, so Bill C-17 will be able to help this database?
Dr. Meuser: I believe so.
Senator Enverga: Thank you.
Senator Seth: Thank you, doctors. Good presentation. This question is for Dr. Peterson.
You just mentioned in your statement that according to expert consensus, Canada's post-market legislative and regulatory oversight of drugs has fallen behind international jurisdictions to which we often compare ourselves, in particular, the United States and the member nations of the European Union. Why is that so and what can be done to improve the system?
Dr. Peterson: I'm referring, senator, specifically to provisions that exist either in legislation or in regulation in those other jurisdictions. They were brought forward a number of years ago.
I do recall that an intention on the part of government a number of years ago, with a previous bill to amend the Food and Drugs Act, that would have provided a number of these provisions as well. So these additional years of delay undoubtedly are related to the cycle whereby the legislation could be brought back before you.
But it is clear that both in the United States and in the European Union, through their consolidated European Medicines Agency, that the provisions for these post-market authorities have been in existence for a number of years.
They also have made provisions for the opportunity for the minister to compel studies in special populations. Again, you know that I have a very vested interest in the pediatric population. This brings to our attention the fact that this act, Vanessa's Law, relates to a child and medication use. The authority of the minister to compel studies in special populations is extremely important, and the other jurisdictions have had that for years.
Senator Seth: The previous witness mentioned that we should stop reporting adverse reactions that are already known because it causes unnecessary work and is a burden. Don't you think that this information would be useful in providing statistical information, like how many patients got sick, where the reactions occurred in Canada and all of that? What is your view?
The Chair: Perhaps I could clarify the testimony previously. The statement related to adverse reactions that had been well documented and are well-known within medicine. It did not refer to adverse reactions broadly. In that context, perhaps you could answer the question, Dr. Meuser.
Dr. Meuser: I think they deserve to continue to be reported for quantitative purposes to know how many. Certainly if a particular reaction falls well within a known syndrome, then it can be called that and doesn't need to be documented qualitatively to any greater degree than that. Certainly, the quantitative information is still useful.
Dr. Peterson: I agree with that fully. We are going to have to create processes that permit the reporting of these reactions without creating a tremendous overhead, either on the part of those recording or on the part of government to go through those. We have electronic means now in order to facilitate that.
I agree completely. When an adverse reaction occurs, it needs to be reported. I can give you examples of that, but in the interest of time I will not now unless you would like that; or I could submit it in writing to you following the meeting.
Senator Seth: Thank you.
The Chair: Dr. Peterson, I want to follow up on this business of transparency. I find it really interesting. First, you are familiar with this committee's studies and reporting and its arguments in favour of greater transparency. Of course, you are more familiar with the issue than that because of your broad experience with regard to the issue of transparency, clinical trials and the evidence behind the approval of any given pharmaceutical.
I've been quite struck by some of the academic publications starting to appear now that the European Union and the United States have moved some distance forward regarding enhanced transparency within the clinical trials. While these academic reports still laud the value of complete transparency, they have noted three possible concerns with complete transparency. Two of them fall into a very minor likelihood category, but I'll simply list them and then ask about the third.
The first one is that even though the data is anonymous with regard to patient identity, the academic concerns are that it might be possible, through extra sources of information and the genetic data that's increasingly available, to be able to identify individual patients within the clinical trial. That's likely a very minor possibility at this time, but nevertheless is one they identify.
The second one is that they bring back the concern about competitive business information being available to other drug companies. We know that in many of the European cases or indeed some worldwide, one drug company in particular and some others have gone quite a distance on their own to publish and to make their clinical trials transparent.
I'll come to the third issue, which I think has always been a concern with regard to the interpretation of adverse drug reactions. With enhanced transparency being available online, there may be those who do not have a good ability to analyze clinical trial data and would draw incorrect and perhaps alarmist conclusions without real basis for their interpretation.
The final thing I will say in that regard is that the same academic papers argue that an independent body should give authority to those who see the full clinical data to ensure that they have the technical and scientific capability to analyze the data in a real context.
This really is a subject for the future, but since there is a moment here, could I get your comment on these aspects?
Dr. Peterson: I believe that all three of those concerns are very real, even the first one, given the fact that we are moving toward an era of personalized medicine. We certainly are looking at solutions for rare disorders and uncommon conditions where we're seeing clinical trials that may have 20 to 30 people enrolled. I believe there is a strong reason to have concern as to the protection of patient identity under those circumstances.
Rules have been created. Statistics Canada is a good source of how to maintain anonymity amongst groups when you're disclosing data. Therefore, some guidance can be put toward that. It is a real issue.
I believe that the non-disclosure of clinical trial information based upon confidential business purposes could be debated aggressively by companies and others. I believe that the bottom line is: What is in the interest of the health of individuals who will be exposed to those products and what is necessary for them to make informed decisions? As we have seen, some companies have taken a corporate position of disclosing everything and making their clinical trial information available.
I believe that we're talking about making clinical trial information available after the product has been approved for market. Quite honestly, there are many sources that we can go to today beyond the manufacturer. We can go to the FDA's website and find the clinical trial data. We can find reanalysis by the FDA statisticians of the same data, for example, and have good access to that. This comes out after the decision has been taken for the product to be on the market or not. As such, it falls into that realm of where I acknowledge a company would like to consider that to be confidential, but I don't believe that we would be transgressing any of our international treaty agreements by disclosing that information.
I would hasten to add in that regard that if all of the information is available on the FDA website or within the European website and readily available, I would not like to see an additional economic burden be placed on the department in Canada in order to add yet again another site where that same information would be made available. I believe that there needs to be some discretion around how Canada would go down that path. However, I would like to see no impediment for Canada to be able to disclose that information, should it believe that it is not readily available.
The third point is quite perplexing. The concerns that have been expressed would be concerns that I have as well, particularly when it comes to large databases being made available. I can query a large database with a question, and the database software will give me the answer. I may draw a perfectly wrong conclusion from the information provided to me because the competency to interpret that health information is simply not something that I hold.
I believe that we need to be careful about how easy it is for this information to be reinterpreted. However, there is a lot of information within social media on Internet sites now that is quite wrong and potentially harmful to individuals. We need to ensure that the authoritative and correct source of interpretation of the information is available to individuals. That can be done by government, government agencies or peer-reviewed research that is sponsored by the Canadian Institutes of Health Research. It's something that's important to keep in mind. I can't see that it should be an absolute showstopper here, though.
Dr. Meuser: I'll defer to Dr. Peterson's experience and expertise on the first two points.
The third point, though, is really very germane to the work of family physicians. It simply tells us what we in clinical primary care practice already knew. We need trusted sources of information and fairly highly digested information as well.
One of the issues with essentially relying on clinical trials for clinical decision making is that patients involved in clinical trials are not at all like the patients that we're we treating. Patients involved in clinical trials have a single problem and they're being studied in highly controlled situations, whereas the patients we're dealing with have multiple problems and have multiple conflicting reasons for any given symptom or reaction occurring. Therefore, what we need is essentially a nuanced version of the clinical trial that basically has something to do with our patients.
As an organization, we are beginning to equip ourselves to become that trusted source on the scientific level. We're connected with 17 medical schools, so we have the capacity within that context to make use of that level of expertise that is available to our members and the organizations they are part of.
Even more important than that, very often it's not science that is at the basis of important decisions; it's practice experience. We're also beginning to equip ourselves to become advisers to one another to allow us to pose the important clinical questions. For us, the question has a lot to do with the science but also has to do with the other clinical aspects. For instance, the important question for us is not so much what do you do about this adverse drug reaction but what do you do about this adverse drug reaction in a 47-year-old smoker who is also taking this and this medication and has this and this background health problem and lives on the street. The clinical decisions we make of course have to take into account clinical trial information, but also so much else that, in fact, the assistance of colleagues is often invaluable in this.
The Chair: Thank you. Your comment fits in exactly with our studies. We have been advocating with regard to the need for extensive adverse drug reaction in the real world proposition, the issue that you've raised. We've written fairly extensively during our study in pharmaceuticals about the fact that the control trial does not represent the human population. It's the real world experience that is critical, and the life cycle approach to understanding a drug in the real world is absolutely critical. We certainly understand and appreciate the specific example you gave that illustrates that well.
Thank you both very much for this very important testimony before us today.
Thank you, colleagues, for your questions.
(The committee adjourned.)