Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 16 - Evidence - June 6, 2014
OTTAWA, Friday, June 6, 2014
The Standing Senate Committee on Social Affairs, Science and Technology met this day at 8:03 a.m. to study prescription pharmaceuticals in Canada.
Senator Kelvin Kenneth Ogilvie (Chair) in the chair.
The Chair: Ladies and gentlemen, I am very pleased to see you here this morning. First, I will give a general overview of the situation here, then I will ask everyone around the table to introduce themselves and we will get right into an open discussion.
As a bit of background, we did this once before in an earlier study where we were charged with reviewing the 2004 health accord. At the end of that study, we held a round table like this and I believe it was a tremendously enjoyable experience for everyone who participated and tremendously informative in terms of the issues we were dealing with.
The intent of this meeting today is to have an informal discussion. There are no television cameras in the room, so you can take off ties and other things without worry, which we will probably need to do. We are in close and comfortable today in this room. Not all of you have been engaged in all the phases of our study, so I will give a brief review.
For the last three years we have been studying prescription pharmaceuticals in Canada, looking at it from four distinct points of view and starting off with clinical trials. We produced a report on that. We followed that up with a study on what happens next; that is, post-approval monitoring. We produced a report on that. We followed that with a study on off-label use and produced a report on that. We have just completed our study on unintended consequences. The steering committee has the first draft of a report and hopefully the committee will deal with early it on our return in the fall.
At this point we wanted to bring back those witnesses who contributed greatly to our study and who were very good at putting their thoughts to a committee and in discussion, and have considerable specific and general knowledge of all of the areas we are dealing with. We put together a list of principal topics that we wanted you to think about and questions within those topics we wanted you to have thought about before you came here.
The format today will be that I will get each section going by picking on one of you to start the discussion. In general, our senators will not be asking questions. We've put the questions to you. They may ask questions of clarification to make sure we understand for sure what you're dealing with, but today we're here to hear from you on the issues that we have been dealing with for this period of time.
There will be a break in the middle of about 15 minutes. We will end for sure at twelve o'clock and not a minute later. If we get everything done before that we may end early, but we will not go long. I will ensure that we adhere to that deadline.
At this point, I'd like to have everyone do a brief introduction of themselves. I will start here and move around the table from my left. I'm Kelvin Ogilvie from Nova Scotia, chair of the committee.
Senator Eggleton: Art Eggleton, senator from Toronto and deputy chair of the committee.
Tina Saryeddine, Assistant Vice-President, Research and Policy Analysis, HealthCareCAN (formerly ACAHO-CHA): Good morning. I'm Tina Saryeddine. I am here for HealthCareCAN. This is actually our first appearance as HealthCareCAN. HealthCareCAN was previously known as ACAHO-CHA, the Association of Canadian Academic Healthcare Organizations and the Canadian Healthcare Association. We just had a name change as of June 1, so I'm very pleased to be here on behalf of HealthCareCAN.
Dr. Colin D'Cunha, Director, Global Medical Affairs, Apotex Inc., Canadian Generic Pharmaceutical Association: Good morning. My name is Colin D'Cunha. I work for Apotex, but I'm representing the Canadian Generic Pharmaceutical Association today.
Janet Currie, Representative, Psychiatric Medication Awareness Group: Hi. My name is Janet Currie, and I'm representing two national organizations: the Psychiatric Medication Awareness Group and PharmaWatch.
Senator Cordy: I'm Jane Cordy and I'm a senator from Nova Scotia. Thank you all very much for coming to enlighten us.
Maureen Smith, Secretary, Canadian Organization for Rare Disorders: Good morning. I'm Maureen Smith, and I'm a volunteer with the Canadian Organization for Rare Disorders. I'm the secretary.
Perry Eisenschmid, Chief Executive Officer, Canadian Pharmacists Association: Good morning; Perry Eisenschmid, with the Canadian Pharmacists Association.
Matthew Herder, Assistant Professor, Health Law Institute, Faculties of Medicine and Law, Dalhousie University, as an individual: Good morning. I'm Matthew Herder from Dalhousie University.
Jack Corman, President, Institutional Review Board Services: I'm Jack Corman from IRB Services. It's Canada's largest independent and accredited research ethics board.
Jared Rhines, Vice-President, Scientific and Strategic Affairs, Rx&D: My name is Jared Rhines, representing Rx&D, Canada's research-based pharmaceutical companies.
Jennifer Zelmer, Executive Vice-President, Canada Health Infoway: Hi. I'm Jennifer Zelmer with Canada Health Infoway.
Mary Wiktorowicz, Chair and Associate Professor, School of Health Policy & Management, Faculty of Health, York University, as an individual: Mary Wiktorowicz from York University, School of Health Policy & Management.
Senator Seth: Asha Seth, senator from Ontario. I am pleased to see you, and welcome to all of you.
Michael Gaucher, Director, Pharmaceuticals and Health Workforce Information Services, Canadian Institute for Health Information: Good morning. My name is Michael Gaucher. I'm from the Canadian Institute for Health Information.
Dr. David Juurlink, Head, Division of Clinical Pharmacology and Toxicology, Sunnybrook Health Sciences Centre, Institute for Clinical Evaluative Sciences: I'm Dave Juurlink, a physician in Toronto with an interest in drug safety. Of some relevance to the discussion, I was a pharmacist in the past.
Senator Stewart Olsen: Carolyn Stewart Olsen, senator from New Brunswick.
Brian O'Rourke, President and Chief Executive Officer, Canadian Agency for Drugs and Technologies in Health: I'm Brian O'Rourke, President of the Canadian Agency for Drugs and Technologies in Health, CADTH.
Dr. Robert Peterson, Executive Director, Drug Safety and Effectiveness Network, Canadian Institutes of Health Research: Good morning. I'm Robert Peterson, Executive Director of the Drug Safety and Effectiveness Network at Canadian Institutes of Health Research.
Senator Chaput: Maria Chaput, senator from Manitoba.
Amir Attaran, Canadian Research Chair, Population Health and Global Development Policy, University of Ottawa, as an individual: Hello. I'm Amir Attaran, a professor in the Faculty of Law and the Faculty of Medicine at the University of Ottawa.
Ronald Heslegrave, Executive Director, William Osler Health System, as an individual: Ron Heslegrave. I'm the new corporate chief of research at the William Osler Health System. That's a relatively new position. Previous to that I was at the University Health Network.
Senator Seidman: Good morning. I'm Judith Seidman, senator from Montreal, Quebec.
The Chair: Thank you, colleagues. We also have the clerk of the committee, Jessica Richardson, and our esteemed analyst Sonya Norris is with us here today to keep us in order.
I will get right into the discussion to open up on the first theme. I'm going to go through the themes in the order that I think they were listed in your document.
The first is clinical trials, and I'm going to tap Ron Heslegrave to start us off with comments. Following that, I want you all to join in with observations and thoughts with regard to updates and issues that you think should be brought up-to-date on this particular topic.
Ron, please start us off.
Mr. Heslegrave: Thanks so much. Being tapped first, I'm trying to figure out what the process is.
I'd like to first of all thank the Senate committee for taking the bold stand it has through a number of these areas. I was fortunate enough to participate in the clinical trials hearings, and I appreciate all of the hard work that senators have done on this. It's a credit to you all.
A number of questions were raised with the clinical trials, through the clinical trials recommendations. Although I may not have the most current agenda for this, maybe the best thing to do is talk a bit about the first question in the suggested questions list that I received.
This talks about the federal government announcing a new entity, the Canadian Clinical Trials Coordinating Centre, as a collaborative effort of CIHR, ACAHO — Tina, I'll get that yet, your new name.
Ms. Saryeddine: HealthCareCAN.
Mr. Heslegrave: Moving forward, the first question put to us for this was, "What do you know about the steps taken to decide on and implement the creation of the Canadian Clinical Trials Coordinating Centre?" And, "What are your views on its development?"
When I was looking at this and looked into the CCTCC I was a bit surprised at the funding envelope for this. There is a considerable mandate associated with this new committee, but the funding envelope for it seems to be relatively light.
The first question I would raise is whether they have a reasonable shot at accomplishing their goals and their mandate with a budget of $1.5 million, at least according to what's available on the Internet, and I am not sure if it's accurate.
A couple of years ago I put together another organization called Clinical Trials Ontario with a much smaller mandate at the time. That was resourced from the Ontario government to the tune of $4.5 million over three years. This is $1.5 million over three years. My question with the group here would be: Is this coordinating centre sufficiently resourced to actually fulfill its mandate? I would be looking for comment on that first.
Following that, there are other issues around this particular question.
The Chair: Thanks, Ron.
I want to point out that if you will signal the chair, the clerk will take a list of potential speakers. You don't need to continue on with a single theme question. Ron has raised a question, and anyone can come in on that, but with the other issues we listed for you, please feel free to jump in.
The experience from the first one is that once we get a few of these going, and Ron has started us off with a specific aspect, it starts to roll.
For those of you who are looking at this, please signal us. Jack Corman indicated that he would like come in on this.
Mr. Corman: I would like to thank the committee also for the invitation and an opportunity to participate in this critical exercise.
I would like to echo Dr. Heslegrave's comment. I believe this agency is a good idea but underfunded. Also, its mandate is too restricted.
Speaking for the private sector, I think there has been omission of the role that we play in clinical trials in Canada. This will sort of jump ahead to the question of registries. We combed ClinicalTrials.gov. Of all the clinical trials registered from 2012 to October 2013, there are 1,006 sites in Canada, of which 716 are private.
If we add the phase I clinical trials for generic drugs, there are probably 500 a year that are all pretty much done in the private sector. It's not a stretch to say two thirds of the research is done in the private sector. We would like to be included as a full partner. We think we could contribute and we think that a central office like this can do much for us, but not with the present mandate and not with the present funding level.
The Chair: Thank very much, Jack. In fact, I am sure you will know that we recommended that the country move in that direction.
Senator Eggleton wanted a clarification.
Senator Eggleton: One thing we need to clarify is what relationship this new coordinating centre will have with Health Canada. Health Canada is essentially the regulator, so I see them being hands off this and not involved with it. This will deal more with the promotion of clinical trials, and that's a good thing. I think we have to be careful about mixing the purposes of the different organizations, so any further comment you may have on its relationship to Health Canada would be appreciated as well.
Mr. Corman: I would 100 per cent echo Senator Eggleton's comment. It is essential that the regulator be purer than the driven snow on this. We're really talking about a promotional activity related to bringing more research, retaining what we have and growing the numbers of industry-sponsored trials in particular.
Yes, I think your point is an excellent and critical one.
Dr. Peterson: I can speak from the perspective of the Canadian Institutes of Health Research, one of the principal partners in the triad that has brought the Canadian Clinical Trials Coordinating Centre into existence. This is a principal component of the strategy on patient-oriented research. While many diverse opinions will have expectations of this centre at the outset, its role is purely coordination at this point in time in order to help organize a collective approach to improving the environment for clinical trials.
There has been a good deal of activity and accomplishment in that regard. An executive committee was appointed in 2013 and a director for implementation of the centre was recruited this past year. Several working groups have already been convened and, in fact, have already published the outcome of their studies at this point in time.
The first was a working group called the Canadian Clinical Trials Asset Map. That working group is still working in order to help collect and assemble what the resources presently are in Canada to support clinical trials. A model clinical trial agreement working group was struck and has completed and published its findings in the form of a model agreement that people can rely upon. The Streamlining Health Research Ethics Review Committee was struck and has also published its work at this time.
You get a flavour from this of what the coordinating centre is. So $1.5 million is not a great deal of money if this were to be a comprehensive approach to actually do the work of assembling a clinical trials infrastructure. That is not the purpose. The purpose is to coordinate this activity: strike working groups, coordinate a good deal of external activity, bring experts to the table in order to do that.
I would only add that the role of Health Canada, as you point out, is peripheral to this. However, in certain areas — and I know that you will be talking about ethics subsequent to this — Health Canada has worked in a fashion that is constructive to the work of the coordinating centre by virtue of looking at standards for research ethics boards, something that the centre will be looking at as well.
Collectively, the centre is identifying those areas that need to be integrated. That will create efficiencies by virtue of a common template for ethics boards to follow, a better understanding of the template for making application for clinical trials in Canada, et cetera.
The Chair: Great.
Amir Attaran, you are next on the list, to be followed by Jared Rhines.
Mr. Attaran: Thank you very much. I will offer reaction to some of what I heard. Possibly this will have me sounding like a gadfly, but that is not exceptional.
I have three points. In response to Dr. Peterson, he says one of the objectives here is to reduce duplication in the ethics process by having a template for ethics review. That is welcome but I don't think it is sufficient, and the reason is having a common template implies that you will conduct an ethics review in the same way, one after the next time. You will follow the template, but it doesn't do anything to address too many ethics reviews, too many in number. That is a different question from the template.
Let me illustrate what I mean. If you do a clinical trial now with patients recruited from 10 sites — you pick 10 cities in Canada, 10 sites — you need to do 10 ethics reviews if those 10 sites are at 10 different institutions. Even though you are doing exactly the same thing in 10 different places, you need to ask the same ethics question 10 times over. Having a template will ensure you are asking the same questions every time, but it won't reduce the overall duplication. My first point is that the template is helpful, but it is not sufficient. You need to reduce duplication particularly where, as Mr. Heslegrave said, the funding is not tremendous for this, so wasting it on unnecessary duplication is really of no use.
Second, and I say this to Dr. Peterson, CIHR is far too demanding in the sorts of things that they want ethics reviews done for. I will give you an example.
We recently did a piece of research were we interviewed physicians in Ukraine about prescribing habits for patients in pain. If you had a cancer patient who is in pain, for example, what medicines could you prescribe to him or her? We had to undergo a painfully long six months' ethics review just to be able to ask doctors questions. This is not a case where you are applying an experimental therapy to a patient and you are risking that patient's well-being. I understand the need for ethics review in a case like that, but where you are just asking doctors questions?
In another case where we needed ethics review, we were asking bureaucrats questions.
In another case, we were buying medicines at a pharmacy. We needed ethics review to buy medicines at a pharmacy. This is ridiculous. There is an overbreadth of where ethics review is demanded, and that is squarely the fault of CIHR, SSHRC and NSERC. That has to be fixed or we are wasting money.
Third, in response to Mr. Corman, I think it would be rather unwise to extend this new mechanism to the private sector overall, and specifically to clinical trials done for generic medicines. If you have little money in this mechanism, which is unfortunately the case, it should be focused first and foremost on clinical trials for novel therapeutics that push the limits of what treatments are available now and in the future. You should be using your resources first and foremost on new inventions. A bioequivalence trial is the sort of trial you perform to show whether a generic medicine performs the same as a branded medicine. It is very necessary research; it has to be done, but that does not bring a new therapeutic to the market. It simply brings a new product, a new version of an old therapeutic to the market. That, to me, seems a low priority.
The Chair: To clarify with regard to the bio-comparison, are you looking at pharmacokinetic studies in the laboratory as opposed to any human subject testing for the actual in-body experience?
Mr. Attaran: Great question. You have to look at both. You have to look at, for example, if the tablet is soluble. Then you also administer it to the patient and see how quickly it rises in the serum and how quickly it falls.
The Chair: I just wanted to know where your request ended.
Mr. Corman: I would like to respond. I do think that the so-called BAV studies, which are to test new formulations of old drugs for generic purposes, should qualify as exempt from registration.
I think there is a real misunderstanding of what happens in the private sector. We do first-in-human studies. We do early phase, phase II, studies. There is a lot of work going on that I think is not really well known.
With respect to the CIHR requirements and the TCPS, there is a definition of what constitutes research that requires ethics review. I think tweaking that definition and being more careful about defining what requires ethics review would go a long way to ameliorating the problem.
In the U.S. there is a formal exemption status that IRBs can determine of projects that are put to them. If we are going to try to fix what you are saying, I think that might be a useful model.
On the issue of duplication, I can tell you, again looking at the data, that those jurisdictions that have harmonized ethics review — OCREB is an example, Alberta is another — the single review has not resulted in more trials; in fact it has gone down. Newfoundland is another example. I think there are more structural problems with how ethics review is actually done at the committee level that also need to be addressed.
The Chair: Thank you.
I will let Dr. Peterson come in because he was specifically mentioned in this, and then I will go back to the list.
Dr. Peterson: In the spirit of not being defensive here, I can only agree with my colleague that there is tremendous duplication in research ethics review these days. However, in a step-by-step fashion, the first step would be to build confidence. In other words, the multitude of research ethics boards can be coalesced only if you create an environment where there is confidence that the local research ethics board can have in the coalesced research ethics review. Therefore, you have to have confidence that if a central committee is reviewing the application, then they would use the same criteria that you would use locally. That is the confidence-building exercise.
Step one in that is certainly to create a common set of guidelines that everyone agrees upon. Under those circumstances, then you have opened the door to a more centralized agreement. I believe that there is full agreement with that, but there is a step-wise approach on how to achieve the solution.
CIHR being too demanding: I'm not sure that anyone would apologize for being too demanding in terms of what the safety of patients would be in the research ethics environment. I can't go into that to a large extent, although I can tell you, particularly in mentioning an offshore study, that there are — and by the way, this is not a central CIHR requirement. CIHR works through a peer review system. These are peer reviewers who may identify in the review of an application some concerns that need to be addressed by the investigators.
Certainly, in the case of offshore studies, there is concern that there may not be a research ethics establishment, per se. There may be a sign-off, but there's not great confidence in that. That's why there appears to be some bureaucracy on that.
The Chair: I think Amir's comments were clearly focused on a special example aspect. You've touched on a different aspect of that. I'd like to have the other comments come in, but these are very important issues on the table.
Mr. Rhines.
Mr. Rhines: My comments started off much longer, but everybody has said very smart things, so I have less to say.
I just want to clarify that the Canadian Clinical Trials Coordinating Centre and the clinical trial action plan is an inclusive process. In addition to the three funders and the executive committee, we are building an advisory board that consists of representatives from universities, researchers, government and Health Canada. So this is guided by an advisory board with a wide breadth of experience and focus.
The other thing I would say around mandate, there is really a singular mandate to this action plan and no prescription necessarily on how to go about it. The mandate is to improve Canada's competitiveness on an international scale with clinical trials. What can we do to drive more clinical research into Canada?
Senator, I applaud the group you have here, and I heard your initial comments. As Rx&D, we'd love to see this process more often. We think that the answers to most of our health care challenges exist around the table, and we welcome these discussions. The action plan is one of those. We welcome all ideas and all opinions and to really drive not only industry but private research and academic research to help make Canada more competitive to drive our global investments. It's an incredibly competitive international environment for clinical trials now, and we desperately want Canada to win. That's what this action plan is geared around.
The Chair: Thank you, Jared. I think that's a real common objective here.
Ms. Saryeddine: From the perspective of HealthCareCAN, one of the three partners, we are delighted to see the CCTCC up and running. We believe it will make an important contribution in ensuring Canadians at large and patients in particular don't lose out in advances in science and technology. This is why HealthCareCAN is supportive. We are going to be monitoring the progress along the way, helping to enlist the support of our member organizations and ensuring that patients' interests come first.
On the topic of resources and partnerships, more is always better. Just as Jared said, there's an advisory group, working groups and outreach to as many organizations and partners that we can have.
You'll notice in the press release there's mention of in-kind contributions. It's not only the cash resource that helps the CCTCC but also the partnership and collaboration of other organizations, all the academic health care organizations across the country, as well as the partnership and collaboration of organizations like the Network of Networks, Clinical Trials Ontario, the British Columbia Clinical Research Infrastructure Network, Alberta Innovates Health Solutions, the Saskatoon Centre for Patient-Oriented Research in Saskatchewan and our colleagues in Manitoba, Quebec and the Atlantic provinces. All of these organizations have been very generous to HealthCareCAN in terms of providing advice and support and helping get this CCTCC up and running.
We're looking forward to collaboration, and I think that's one of the really important things, as Dr. Peterson and Mr. Rhines said, about how the CCTCC can succeed in building resources from an important starting point.
The Chair: Thank you, Tina.
Maureen, please.
Ms. Smith: The first thing I'd like to say is how pleased the Canadian Organization for Rare Disorders, or CORD, is to be here. It is wonderful to be invited, along with Janet, to come to a Senate round table to testify and to give our opinion with all of these esteemed people by taking a patient group and saying, "You are equal to the other people in the room, the presidents of different organizations." I think we've come a long way. I don't think this would have happened even five years ago, and I applaud the committee for doing that. Rather than having a separate meeting with patient groups, to integrate us into this kind of meeting we think is a very powerful statement, and I'm very happy to be here.
As far as the CCTCC goes, CORD strongly supports it, but we also want provisions to make sure that patients with rare diseases are not doubly disadvantaged. We are disadvantaged in clinical trials in three ways: first of all, the number of clinical trials; secondly, access to clinical trials; and thirdly, the appropriate design of clinical trials for small populations.
I'm going to speak to you personally because I think it's the only way that I can really get the message across.
I was diagnosed with a rare disease when I was 8 years old. It's 5 in a million. I was on a clinical trial for 10 years, a longitudinal study. When that ended, I didn't have access to clinical trials or the appropriate medication for 20 years. My health deteriorated rapidly to the point that I was using a walker and I was lying in a bed.
At that time, there was no Internet. I used to go to the medical library at the University of Ottawa. The librarian thought I was a student and whispered in my ear one day, "How come you haven't graduated yet?" I was there all the time. I was looking for clinical trials and for doctors to help me. It took 20 years, and finally I got onto a clinical trial. At the age of 55, I'm healthier now than I was in my twenties.
I'm speaking from personal experience about the number of clinical trials for small populations and the access to clinical trials. We strongly support this strategy, but we want to make sure that smaller firms that may not be on the radar of CIHR or may not be members of Rx&D are not left out.
There are three points that we want to call attention to in the action plan. Number three is to integrate the health system and research infrastructure, which we feel is very important for rare diseases. The second one is the efficiencies of ethics reviews and advanced strategic issues like not discouraging clinical trials from happening. The last one is the development of a database of registries and considering a national patient recruitment strategy.
We feel that with special attention to these three issues, this would be a great advantage for patients with rare diseases.
The Chair: Thank you.
I have three people on the list, and I'm going to end this part at that point but with a question for clarification that has occurred to Senator Eggleton. Then we'll go to the next topic.
These things will start coming back as we go along. This is an important one to get it started.
Mary, I alert you that I'm going to pick on you first for the next topic, which is legislative and regulatory framework.
Perry, please.
Mr. Eisenschmid: That was a perfect intervention. I feel we can spend four hours just talking about the new Canadian Clinical Trials Coordinating Centre and the technicalities around that. I wanted to try to take things up a level.
At the Canadian Pharmacists Association, our priority is patient safety, and there are two fundamental issues within the clinical trials agenda that we wanted to highlight. The first one is in the area of reporting negative trial results. As was noted, the majority of the research is privately funded. That tends to lead to only positive outcomes being reported. Unfortunately, as a result of that, negative results are only found out after these pharmaceuticals are put into the marketplace and patients are impacted. The one point we'd like to stress is the importance of more negative results reporting done.
The second area is in the category of special populations, such as children or breastfeeding mothers. These special populations are not well served by research being done today, and we would like to have a more concerted effort to have testing done in these populations.
Ms. Currie: Again, I want to thank the committee for its long-term and systematic approach to the safety of pharmaceuticals. I really appreciate your efforts and your work in this regard.
I have a fundamental foundational question. I understand the development of a clinical trials infrastructure is a commercial venture, a promotional venture, as some of the colleagues around the table have mentioned, and I'm really not sure of Health Canada's role in this. I don't know how this kind of activity relates to the health and safety of Canadians. I'm not asking that to be difficult. I'm really interested in how it relates. Are we developing a clinical trial infrastructure to shape the direction of clinical trials? Are we doing it to establish a stronger ethical framework within which to conduct clinical trials? I'd really like to understand how it relates to the goal of the health and safety of Canadians.
My comment is not just random. Considering the resources of Health Canada, and we've already discussed the lack of resources here today, and many of us are concerned about that, to me, this could be a deflection of resources which could be better placed. I'm talking about not only monetary resources but actually on-the-ground manpower, which could be deflected from more critical areas, in my opinion, such as the registration of clinical trials, which is our next topic.
The Chair: Thank you, Janet.
I'll close this off before I put a couple of questions to you.
Mr. O'Rourke: I'm very supportive of streamlining clinical trials, harmonizing our approaches and bringing more research to Canada.
The one critical aspect as an agency that reviews drugs and makes recommendations to the provinces on listing is transparency, access to this information. It's very crucial that clinical trial information becomes public information, that it's easily accessible to those who review it and builds on what Perry was saying, not just in registering the trials but in reporting of trials, both positive and negative, or less than positive trials. So it's crucial to ensure that whatever we build, we have access to it from agencies like ours, for patients and clinicians to review that data.
The Chair: This is one of the questions we want for clarification. It hadn't come up. Thank you for bringing up the clinical trial database.
Do you see the requirement for total transparency and mandatory publication of those on the clinical trial database?
Mr. O'Rourke: Yes.
The Chair: Thank you. That's clear and to the point.
The final question for clarification is with regard to the CCTCC mandate. We didn't hear any specific comment as to whether you feel that the mandate is broad enough or if there are aspects that should come in. Does anybody have a quick comment on that?
Mr. Attaran: Is there a written mandate yet?
The Chair: We are to some degree seeking information to put in all of this from you who follow these things in general. I'm seeing no one. We'll put that aside for a bit.
Ms. Saryeddine: I can respond to that. There's a little bit of a history that led up to the formation of the CCTCC, and I think it's something that has to be an ongoing conversation.
If you look historically, back in 2011, there was a summit through which we looked at the opportunities that we can use collectively as a starting point to help improve the capacity of bringing trials to our patients and to our organizations. So there was a summit, and from there, a proceedings paper with at least 40 potential "actionables." From those actionables, there was a discussion and consultation about where there is need, capacity, opportunity and appetite without needing too many resources.
So there is an action plan that forms the basis of the mandate of the CCTCC at this point. There are a number of articles in the public domain that can be used to explain that, and it explains what the public health benefits and benefits to patients are. I would invite any members of the committee and the participants here today, if you like, to visit CCTCC.ca, where you will find those documents and the other related materials.
The Chair: Thank you, Tina. That was very helpful.
I'm going to go to Mary and ask her to start us off on the legislative framework in Canada compared to other jurisdictions. We had three general aspects under that to get you to have input. Mary, could you start us off with whatever comments you want to make on any aspect of those three?
Ms. Wiktorowicz: Let me begin with general comments, and then I'll move on to specifics.
First of all, I think the process has to be far more transparent in terms of regulatory review than it is. I think people need to see what is being done. Second, I think we need unbiased evidence and review. I don't think the public is often convinced that's happening either.
Let me begin in terms of specifics. When a product is reviewed at Health Canada and approved on the basis of surrogate end points, it's problematic when there are no long-term studies done. For example, you could take the product for HPV vaccines, human papillomavirus, Gardasil. It was approved on the basis of the surrogate end point that the vaccine will reduce cervical cancer. Cervical cancer will take 20 years or more to develop. There are about 100 HPV viruses. The vaccine addresses four of them, two of which are linked to the cancer. If we reduced the frequency of those two that are targeted by the vaccine, how do we know others won't proliferate and you will still not affect the long-term end point, which is preventing cervical cancer?
When Health Canada reviewed this product, they didn't request any long-term studies, so we still don't know unless we conduct some further post-market surveillance. In the meantime, millions of young women and young girls and boys are being vaccinated and billions of dollars are being spent. We don't have a clear picture of the adverse effects or the effectiveness. That's just one example.
I think under the new legislation there was a measure to allow Health Canada to request additional studies. I think any time there's a surrogate end point that a product is being approved on, you've got to make sure that additional studies are done to verify that the long-term outcomes manifest themselves as is assumed.
In terms of transparency, I think it's great that we're now having a clinical trial registry, but we also need access to the findings. I'm not clear on the exact details of the registry, but if we don't have access to the findings, then that's only part of the picture, and there should be access to that.
Another comment that I have with regard to post-approval monitoring is within the proposed legislation. The idea is to do a life-cycle approach to monitoring new medicines. One of the key vehicles will be to use risk management plans. If you compare Europe to the U.S., Europe has gone with the risk management plans but the U.S. has not. Risk management plans are a weak model because, at least under the European plan, the manufacturers propose how they're going to study the product in the post-market phase. Generally, the regulators simply review it and they accept it, and there's not transparency, first, around what's in the plan and, second, around who is conducting it and how it's going to be conducted.
In contrast, the U.S. FDA, doesn't use risk management plans. The FDA determines whether a clinical trial is needed in the post-market phase, and, if so, they request the product sponsor to complete that trial. If they're going to do observational studies, epidemiologic studies, first, the FDA determines which studies are going to be done, and, second, they don't generally go to the manufacturer to do those observational studies. They link with research centres, where they have the expertise and access to the database of the real-world use of these products to conduct those studies. In those cases, you can ensure the rigour of the studies and you have control and transparency around what the studies are. I think Health Canada would be much better equipped to use the U.S. FDA model than the European model of risk management plans.
The Chair: I took your first comments to place an emphasis on the post-approval monitoring, and I hope you will note that our reports stress that aspect as being the ultimate clinical trial and that we have to do a far better job at picking up that data.
Senator Eggleton: I take it when you talk about proposed legislation, you're talking about Bill C-17 that's now before the House of Commons, also known as Vanessa's Law.
Ms. Wiktorowicz: That's right.
Senator Eggleton: I would appreciate it if others might tell us how they think that stacks up, what is good in there and what needs further improvement.
The Chair: Absolutely. We're not doing a formal study on the bill today, but that's an important point, if it comes up.
Dr. D'Cunha: I want to make some observations on what Mary just said and add further background information. I'm not necessarily speaking as a member of Apotex, the Canadian Generic Pharmaceutical Association.
In the area of transparency of reviews, we should note that our European colleagues published their assessment reports available online to anybody and the acronym is EPA. The FDA publishes redacted reviews so confidential business information is suppressed and, if anything, Health Canada should take their cues from either one of these two jurisdictions so that it's freely and widely available.
In terms of Vanessa's Law, I think it's time to get on and implement. We can all further strengthen things. Health Canada should build on the tons of public input given to them since 2005 as they were talking about amending the Food and Drugs Act.
My last observation is in the area of the U.S. risk management approach. They call it REMS, an acronym for "risk evaluation mitigation strategy." They have a three-point approach graded on risk. The first is drug labelling. The second is a medication guide to guide the health care professional and the patient. The third, which is what I call the whole shebang, is elements to assure safe use. Products such as the long-acting opioids — teratogens in the case of anti- epileptic drugs — fit into this third bucket.
Mr. Herder: I'd like to make a couple of points, first about Bill C-17 generally. I think it's a positive step forward. A number of measures in that bill are important additions to drug safety: the power to issue recalls, the power to enforce conditions associated with market authorizations, the power to require information about adverse events, off-label uses potentially from health care providers and institutions. Those are all key measures. But there is a lack of transparency in the legislation itself. A number of people have been pushing for amendments in that regard, myself included, and hopefully that's something that the government remains open to.
The lack of attention to transparency is highlighted in a number of ways, and they dovetail with Mary's comments earlier.
First, to give you an example that connects with the specific example you used, I'm part of a group at the Canadian Center for Vaccinology that's been trying to get information about the assays used to demonstrate that the various vaccines approved in Canada actually protect against various pathogens. We've filed an access to information request with Health Canada. As we expected, the answer came back that that assay information is proprietary; it's confidential business information.
There's a real opportunity in this legislation to override that kind of working practice or definition or assumption that the information is in fact proprietary, or that even if it is, perhaps patient safety requires that the information should be transparent. Otherwise, we don't really know whether vaccines like Gardasil, quite apart from the issue of surrogate end points, actually work to protect against certain kinds of things. It's an assumption. We need independent interrogation of that assumption.
Last, post-market studies: There is nothing in Bill C-17 that requires the studies to be put forward and to be made transparent in any way. That's another example of why transparency is important and why this bill could be amended in that way.
Mr. Attaran: I think some of what we're speaking about here is not necessarily within the scope of a legislative framework. You have to be careful about this. I might be alone in being the only lawyer. I don't know. But there are certain things that law can do and certain things that it can't do. There comes a point at which, if you try to be too prescriptive about what an agency should do in law, you in fact become counterproductive in helping the agency do its job. There has to be some discretion there.
When I hear discussion about the idea that Health Canada is inappropriately using surrogate end points to approve medicines, and I hear that question raised under the rubric of legislative framework, I'm not entirely comfortable with it, for two reasons.
First, as a health scientist, surrogate end points are here to stay and we'd better just get used to that. The Americans are using it; the Europeans are using it; the Japanese are using it. For us to take a purer-than-white approach to not using it is not feasible. There are some diseases for which you will only ever have surrogate end points. Alzheimer's disease: We don't even know what Alzheimer's disease is. We don't have a proper understanding of its pathogenesis. If you want to create a drug treatment for Alzheimer's disease, you will to some extent be relying on surrogate end points to validate whether it works or not. Yes, you may be wrong about them, but that's no reason to shy away from that therapeutic area, for example.
Second, as a lawyer, the thought that you might actually legislate against using surrogate end points gives me great pause because you would take away from the agency the discretion to decide how to deal with an Alzheimer's disease type of situation. The law of unintended consequences is writ very large here. Leave the agency some discretion. I may be a frequent critic of Health Canada, but I don't want to shackle them, either. They must have discretion.
The point that was made about transparency at Health Canada being poor and not being adequately upheld by the Food and Drugs Act is absolutely correct. More transparency is needed. Several people have made that point.
Last, the point about Vanessa's Law, Bill C-17, you will have an in-depth study of it, I'm sure, so I'll keep my comments brief on this. For the most part, it's a welcome advance, but it does one thing that I find absolutely alarming, and it's this: You will recall when I appeared in front of your committee, Mr. Chair, that I said our penalties for drug crime are far too low, for drug falsification, adulteration, and so forth. I said at that time the maximum imprisonment is three years. Vanessa's Law cuts it to two. It's reducing the imprisonment penalty; the fine goes up substantially. Why we would choose, as a legislative act, to go softer on drug criminals is beyond me.
The Chair: Thank you. Once again, your point is well taken in the scheme of things, which is again why hearing from all the experts over the course of our studies, the idea of the post-surveillance monitoring to get at the long-term benefit in an area is so critical in determining the effectiveness in the long-term progression of any illness.
Mary, you wanted to come back on this.
Ms. Wiktorowicz: With all due respect, Amir, I wasn't suggesting that surrogate end points shouldn't be used for approvals. I was only indicating that if the surrogate end point is the basis for the approval, then Health Canada should have the ability to require additional clinical trials to be done to verify the final end point in terms of efficacy being achieved and product safety being confirmed. That was just a point of clarification.
Ms. Currie: I just want to say, too, that I think in terms of the public interest, understanding the meaning of surrogate end points is very important. If I had breast cancer and I was told that the drug I was taking reduced the size of the tumour but had no effect on my long-term survival rate, that is something I would really like to know, particularly if that drug was exposing me to a lot of very difficult side effects. I think it's a question of being transparent about what is being measured.
I want to quickly address the mandatory registration of clinical trials, because to me that is the centre point of transparency. I don't see how researchers, Health Canada — well, Health Canada does have the data — but 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. The research is replete with literature showing that we do not have access to negative clinical trial outcomes, that we have access to positive clinical trial outcomes, which often distorts the efficacy and safety of a drug. I'm thinking of a lot of psychiatric drugs particularly; whereas if we had full access, I think there would be a second thought about their safety and effectiveness. I really want to support that. I do not know of any work that Health Canada has done on that — maybe I am incorrect — in terms of robust consultations leading towards this policy change.
When we look at it, we certainly want to be very concerned that trial results of older drugs also be available because some of the policies in other countries have only looked at more recent drugs. We need to have the history of older drugs and also of drugs that have not been approved.
The Chair: I am assuming with regard to this section that you are implying that the transparency issue should be heightened in the legislation.
Ms. Currie: Yes, and we that need to move forward in a robust way on this.
The Chair: I just wanted to clarify because we are going to deal with transparency overall next.
Dr. Peterson: I think we are all in agreement that the regulator requires greater authority in the post-market environment to move beyond requesting studies by the manufacturer to requiring studies in order to fill the gaps in evidence.
This legislation is written as acts typically are. It is enabling wording that provides the basis for government then to move into regulations that will go into the details of exactly what has been talked about here today. I can only offer the advice from prior experience that when there is such a large dependency upon the regulations to provide the level of clarity that has been voiced during these reviews, it is not out of the question for government to ask to see a draft of these regulations before you have full confidence that the enabling wording in the legislation will actually meet what the response has been. In my opinion, that would be something very much in order at this point in time.
I can only concur with the statements with regard to transparency. Bill C-51, as I recall, had much stronger wording along the lines of transparency, particularly sharing the information agency to agency. At this point in time, the Canadian Agency for Drugs and Technologies in Health must ask permission from the manufacturer to get the information that was submitted to Health Canada in order to be able to do their next review. Bill C-51 would have enabled some authority for the ministers to simply allow that to happen.
As a reviewer or someone dependent upon this information, I can tell you that EPAR in Europe does have a counterpart in Canada, and that is the summary basis of decision. You can hold these documents side by side and see that Europe looked at these trials and Health Canada looked at these trials. Unfortunately, sometimes you will see that Europe took a different decision based upon that than Health Canada did. That's the nature of meeting the needs of your own domestic health care system that causes variation along those lines.
The idea that we need to move beyond the issue of balancing early entry of products for life-threatening conditions that are typically based upon surrogate outcomes to having a greater degree of confidence at the time that the product comes onto the market is an ongoing challenge. We know that breakthrough medications require early entry. The enabling authorities in Bill C-17 allow government then to define what they believe in the Canadian context, not what Europe has asked for or what the United States has asked for, but in the Canadian context, those studies.
Since the inception of the Drug Safety and Effectiveness Network, once again Health Canada has an avenue to which they can turn to ask for epidemiologic studies around post-marketing products that will answer some of these questions. Uniquely in Canada, that query is outside of government. It is at arm's length from the regulator and creates an independent assessment of what the post-marketing environment is.
In the case of the United States, the Sentinel program, which is the counterpart to a good part of DSEN, exists within the FDA. It's not at arm's length, albeit, just as in the case of DSEN, Sentinel makes their results public and publishes those studies.
The Chair: Thank you. I will close the list on this topic and move to the next one.
Mr. Eisenschmid: Again, from the lens of patient safety, which is our primary concern at the Canadian Pharmacists Association, I would like to comment a bit on the specific areas of required reporting and disclosure of adverse reactions.
Everybody has to realize that every drug marketed in Canada results in adverse reactions to some degree. That leads us to three high-level priorities. One is that we need to ensure that the disclosure and reporting of information is balanced. What we don't want to do is scare patients away from critical medications because of some of these adverse reactions.
We are concerned from an administrative burden perspective. Clearly, if every drug marketed results in adverse reactions, this could become a rat hole of complex, tedious and burdensome administration. Therefore, we think it is very important that everyone focus on unexpected and serious reactions, not those that are well-known and expected.
Finally, I think we need to deal with the "so what," or in this case the "so what now," aspect around this. It is one thing to talk about adverse reactions and to notify health care practitioners about that, but the more critical point is that they need to understand what they do when there are these kinds of reactions and they are dealing with that. As a result, health care practitioners need follow-through information on what are appropriate therapeutic alternatives.
We received significant funding from Health Canada some years ago to produce a comprehensive research tool called therapeutic choices. It is comprehensive. It's Canadian. It's constantly updated and current. This is one of the kinds of alternatives that need to be made available to all health care practitioners so they can deal with the natural consequences and the "so what now" questions that would arise.
The Chair: Thank you. We will come back to adverse reactions specifically down the road.
Mr. Rhines: I wanted to comment on your previous question about views on C-17. Rx&D and our members are fully supportive of Bill C-17. Our concern is that it seems to pit the interests of patients against ours. Our members are very interested in patient safety, and we are willing partners in trying to ensure patient safety from transparency.
We do agree with others around the table that the bill could have gone further. There are some things it fell short on. We wished it would have addressed the prevalence of counterfeit medication, which is one of the previous topics we discussed as a committee.
We also believe that there is an opportunity to have gone further with labelling. As you know, the manufacturers go through a rigorous discussion with Health Canada on labelling, but as any of you who have taken medications know, oftentimes those labels don't make it to the patients. Pharmacists apply a different label based on summary data, often not even from Canada but from the U.S.
I think there is a process that, around this table, the continuum providers, including patients, there needs to be significant education for patients to understand what is an adverse event, what do they experience as an adverse event and how do they report that so we can make sure that the necessary information flows not only from industry to patient but back from patient to industry and to Health Canada.
Ms. Smith: CORD is very supportive of Bill C-17. In a nutshell, for patients with rare diseases, it gives the confidence and authority needed to allow drugs to be approved at earlier stages in the lifecycle, with higher degrees of uncertainty as to both effectiveness and safety because there will be mandated post-market surveillance with reporting and transparency. It gives clinicians and patients greater confidence to use products that may be of potential value, especially in rare diseases, but are plagued by the uncertainty. We are very supportive of it, and we urge Parliament to pass it as soon as possible.
Dr. Juurlink: There are a lot of topics but I have a couple of quick thoughts.
First, at the risk of being a bit redundant, is the issue of surrogate end points. I agree with Amir that they're here to stay but they're not really important from a clinical perspective or a patient's perspective. For example, when I put a patient on a blood pressure medicine or a cholesterol pill, it's not really to lower their blood pressure or to lower their cholesterol; it's done with the hope that I accomplish what I really want to do, which is to help them feel better or live longer or avoid disease. It underscores the fact that we give these drugs on the basis of surrogate end points and the sponsor gets them approved by Health Canada on the basis of surrogate end points. I think it underscores the importance of the post-market phase and finding out whether they really do offer benefits that exceed the risks.
I have a comment on the issue of transparency and effectiveness together. It bears on an issue of nosodes that has been in the news recently, these homeopathic vaccines as some people call them.
In a sense, Health Canada has contributed to the spread of things like measles in Canada because they approve these things that amount to witchcraft, in my opinion, these products that are sold to credulous people by others who just simply want to make money and might have a genuine belief that they work.
When you go to the federal government's website to find out a bit about these, they are licensed as safe and effective. They have the imprimatur of Health Canada and so people know that. What's not clear is what they are effective for, very specifically. They are not labelled as being effective for the prevention of disease, but when you ask someone in the government what they are effective for, you can't get an answer to that question.
I think that's a good example of an instance where Health Canada has let down the populous by allowing these products on the market and consequently indirectly encouraging the use of things that don't work to prevent disease.
The Chair: Thank you. I will not open that up right now, but I take your comments to mean you would like to see a stronger legislative aspect to the control of those substances.
Dr. Juurlink: More transparency around why they are on the market in the first place.
The Chair: Regulation or legislation would achieve that end.
Transparency keeps coming up so I'm going to move specifically to the topic on transparency and openness. For no apparent reason I will ask Amir to lead us off in this area.
Mr. Attaran: For no apparent reason? I will go away wondering what this "no apparent reason" is.
The Chair: I will take it back, then.
Mr. Attaran: You've left me an easy job because no one here has spoken against greater transparency. It has received wisdom that we should have it, so I'm going to say we should have it. In order to have it, I think we want to bear in mind there needs to be transparency in several areas.
The clinical trials have been mentioned. Janet's point that there is a bias in reporting positive results but not negative results of clinical trials is very correct and very worrisome. That is why we need transparency of all clinical trials, full stop. This is not something that Canada leads on. We are possibly the worst of every developed country on this. I don't know of a worse one. Maybe Japan is worse, but you have to really go looking for a country that is less transparent on this. So let's make that change.
We should also have transparency on inspection letters and warnings, as the FDA does. And we certainly should have transparency on questions arising with respect to patient safety no matter how they arise: adverse report warnings; warnings about products that may have been diverted from the supply change, which subsequently their providence becomes somewhat in doubt. Transparency should exist for all of these things.
I will make one comment and put a little asterisk beside it — query. If the rest of the world is more transparent than we are on all these issues and Canada is 3 per cent of the developed world drug market — if you look at Europe, the U.S., Japan and us, we are about 3 per cent — do we really need to bring these changes into effect at Health Canada or should we seriously look at an extremely radical option such as abolishing Health Canada's role in drug approval and harmonizing with other countries?
This is a radical idea and it should be considered. The reason it should be considered is the European Union has largely moved in that direction. They've realized it doesn't make sense for Malta to regulate drugs the same way as Germany because Germany is this big and Malta is this big, and so the smaller members have basically fallen in line behind the larger members.
This is not a bad idea for a medium-sized country like our own. Give that some thought because it may prove easier to harmonize some of our practices with other countries than to do a root and branch reform of our practices. Keep that in mind as an option.
On the drug shortages, points 12 and 13, I think we all will agree that drug shortages continue to vex us; they continue to be a problem. I wonder if that is not because we are treating the effect rather than the cause. Largely, the drugshortages.ca website is set up to report drug shortages when they occur or when it's thought they may occur; in other words, at a very late stage in the process. Not much attention has been given to trying to, instead of reporting on the effect, address the cause. Unfortunately, I think we don't know the causes as well as we should. There should be more research in this area.
There is a consensus — I don't know if it's correct or not — that the drug shortages are caused in part by too many drug buyers doing sole sourcing. In other words, you buy all of your needs from a single source, so somebody ends up with a very high market share and other companies end up with a very small market share and therefore choose to leave the business. You're putting all your eggs in one basket, and if you do that then you're at risk.
That's a hypothesis that needs some more testing. I think it's probably true but I'm not going to stand up here and say that it is true. However, if it were to be tested, I think it should be tested by the Competition Bureau because if we get to the point where we are too dependent on a single or two suppliers for a medicine, that's really an anti- competitiveness question not just a health question. This is a place where you may well want to talk to the Competition Bureau or invite them in.
The Chair: Thank you. On that point of drug shortages we learned a great deal about the complications of this particular situation in our unintended consequences study. Off line I have heard of one issue that I hoped might come up from one of our participants here today with regard to possible input into it. There's apparently no single cause of it, but there are a lot of issues that are really important to it. If it doesn't come out, I'll put it on the table at some point.
Senator Eggleton: There are two things I want to throw in the mix here. One is the question of "mandatory" when we talk about more transparency and openness. Where do we draw the line between what should be voluntary and what should be mandatory? Every time we talk about transparency, whether it's the voluntary or the mandatory route, we run up against the commercial protection of information relevant to the products being developed or sold. How do we get around that?
I think public safety also comes first, but I suppose there has to be a line there somewhere. Companies don't want to divulge certain information that exposes their products to a competitor, et cetera. Where do we draw the line?
I, for one, feel that Health Canada uses that altogether too often. I'm concerned about the mandatory and the commercial protection aspects of things.
Mr. Herder: In case it wasn't clear, I'm a lawyer as well.
The Chair: We're not getting into this contest here today. You two just keep that off the table.
Mr. Herder: I'm going to try, as a lawyer, to make transparency a bit harder, despite the chorus of support around the table for it. I think there is a real risk that it's a bit of a pyrrhic victory if we limit how far we go, whether through Bill C-17 or other measures. I want to make three points, and I think the last one will address Senator Eggleton's comment as well.
First, we need to learn from what's been happening in other jurisdictions. We are behind, and there's experience around trial registration in particular. It seems clear to me it's not enough.
The U.S. has had legislation in place requiring registration since 1997 and substantially expanded that requirement in 2007 to include results reporting, which I also think is critical, but compliance is poor. I think it has to be mandatory, but you need to make the regulator accountable to those commitments. That's not really happening. To my knowledge, there isn't a single case of a penalty actually being enforced in the United States. If anyone knows to the contrary, I would welcome that information.
Second, in terms of complicating this issue of transparency, I think it is helpful to think about two different kinds of issues. The first is to talk about the evidence, so registration and results reporting. The policy conversation globally has actually gone in the direction of sharing clinical trial data, perhaps even patient-level data — anonymized to take care of privacy concerns — provided the informed-consent process allowed for that, so those ethical checks and balances have been covered off. We need data-sharing perhaps because registration and results reporting haven't worked that well in practice. That's needs to be looked at.
It's not clear to me that we can go that far or that we have to, but I think from a legal perspective it's critical to put a power in place for the government to potentially do that and then to define, if we want to go down the route of data sharing, for example, what procedures of data sharing should look at. There's a lot of debate about where that onus should be. Should it come from the companies through a trusted intermediary? Should it come from the regulator? Who can have access? Do they have to have top credentials as a scientific researcher? All those things have to be defined, so if you have a power in the law that creates authority for the government to make regulations about that process, that's a starting point that's necessary.
Second, I talked a lot about the evidence behind drugs and medicines and what that would look like in a statute, but I think we have to think a lot harder about regulatory transparency, the decisions and interpretation of that evidence. Summary bases of decisions were mentioned earlier. Based on the reviews, there was a recent paper in PLOS Medicine or PLOS ONE by Joel Lexchin and Roojin Habibi that came to the conclusion, after reviewing hundreds of summary bases of decisions that the quality and quantity of information in those is often lacking. I think there needs to be clearer power to give the regulator authority to disclose its interpretations of the evidence in law, because I think some of what is holding it up is a fear that it might be disclosing information that the manufacturer considers confidential. That needs to be there.
Then there needs to be that sort of culture change within the institution that hopefully that power can start to instill, to go beyond what we have had so far.
To add to that issue of what is and is not confidential information, thinking about intellectual property law, confidential information and trade secrets are different from other kinds of intellectual property. A patent, for example, has to be applied for and is vetted. Confidential information and trade secrets really arise as a result of treating something in a particular way. It's more a question of behaviour. As a result of that, it's all too easy for companies to assert that something is confidential information and proprietary. That's the common law.
In a statute you can override that common law and clearly define something as being outside of that realm, even if courts have suggested that it might be proprietary. There's a mechanism you could use to try and deal with that complication that regulators are very much caught in the middle of.
Ms. Wiktorowicz: I would like to respond to what Matthew has just said. I really agree with the summary basis of decision. Currently it doesn't provide adequate transparency for how the decisions were made on a product, what were the key criteria met in terms of approval. Also, in terms of risk management, what are the post-market kinds of studies that will be conducted to enhance safety in the future?
That's a point of agreement, but I wanted to go back to Amir's point about abolishing Health Canada. I believe that's short-sighted and unwise.
If you look at regulation, there is social and economic regulation. Economic regulation is a more technical matter. Take the example of public utility regulation where companies need to make a certain rate of return and they hold a monopoly on energy production. That's where the issues are more technical and clear-cut.
If you look at the areas of social regulation, and regulation of pharmaceuticals falls under that, there are social and societal values at play in how risk and uncertainty are weighed. That's the first point. What are the frameworks for weighing risk and uncertainty?
Second, risk management has to be linked to the regulatory function in terms of accountability. If there's a safety issue out there, for example when Vioxx was found to be causing heart attacks and cardiac events, our citizens want to be able to hold our government accountable. We don't want to refer to a supranational body or the U.S. We want our government to be able to act on our behalf, and we can't do that if we let go of the regulatory authority. I think that's very unwise.
Then there are examples where Canadian and North American governments have responded differently to regulatory issues than the Europeans, for example. Take a look at bovine growth hormone. It's a veterinary product for increasing production of milk in cows. The U.S. went ahead and approved it. In Canada we looked at it and, in the end, there was a committee that said, no, we don't need that product in Canada. This was a societal value.
If you look at genetically modified organisms and food products, the Europeans are very concerned about the risks and uncertainty related to genetically modified organisms in products and they limit their use and spread. In North America, we don't see the same level of risk and uncertainty, so there is widespread use of genetically modified organisms.
These are societal value judgments that weigh into how the risks are measured. I don't think it is wise to allow another nation or a supranational body to make those decisions on our behalf.
The Chair: Thank you. I am delighted that we're bringing out really serious issues here today. That's the purpose of this, and I'm delighted with the dialogue.
Mr. Eisenschmid: We at the Canadian Pharmacists Association generally would agree with Amir that the greater the transparency the better. However, we would like to highlight one particular exception, and that would fall under the area of drug shortages, which can tend to be a blunt instrument.
Mandatory reporting on drug shortages is probably fine and good if we're dealing with a non-critical drug, non- urgent situation with many substitutes. I would be concerned, however, if we're dealing with a critical, life-saving drug that's in critical shortage without any substitutes. I don't think you want the free market determining the allocation of such drugs, so mandatory reporting might be important for a department like Health Canada but certainly not generally making that publicly available.
I think we need a more refined approach to that kind of area within the drug shortages file specifically.
The second point would be a little repetitive on the other area, which is, regardless of the reporting, I would like everybody to be cognizant of the "so what?" or "so what now?" again always thinking through the follow-up consequence and how we need to arm our health care practitioners with the information they need to make informed decisions based on what we're disclosing.
Dr. Peterson: I just wanted to make a couple of comments for clarification. First, when Health Canada receives a package of information in support of a new drug application, it receives all clinical trials, those positive and those negative. While it is the case that the literature does not often publish negative findings, when the regulator considers an application, it, by requirement in regulation, has all clinical trials, positive and negative.
By the way, there are often negative trials, particularly in dose finding studies where the dose selected in a phase II study was too high or low, and therefore they would go back and be repeated again. So it is the case that Health Canada receives all those trials. There have been occasions, perhaps more publicized in the United States, where failure on the part of a manufacturer to submit a clinical trial results in substantive penalties and publication of that fact.
In Canada, those penalties are being addressed in new legislation. That begs the issue of the fact that the trials still are often not made available to the general health care system, trials that are not positive results in order for independent assessment to take place.
But that, once again, moves into the concept of transparency that we can point to in other countries. In the United States, there are thousands of pages published, the entire application minus the redacted parts. The redacted parts in their mind, discussing this with colleagues at the FDA, suggested those are related to trade secrets and trade secrets only, an area that is best discussed by lawyers, not by a physician.
But it raises the question: If I can go to the website at the FDA and look at all of the information that was submitted, considering the fact that it is virtually the same package that was submitted in Canada, then we want to be very cautious that we're not putting into law a requirement that says we will simply build the amount of information that is on the Internet in a redundant fashion. I can look at the medical reviewer's complete report from the United States FDA that goes through all of the clinical trial data that they had considered, and it's freely available. I cannot do that with a Canadian reviewer at this point in time. While I would like to have their opinion, I don't need to have all of that data put on the Internet again. I can find it. It's there, and the same thing applies to the information that takes place in Europe.
It leads us into the next category of the ability of regulators to be able to work together. Again, I'm not in favour of an abolishment edict as far as the regulation of Health Canada is concerned; however, there is no question that Europe, more than 15 years ago, defined the fact that small-to-moderate-size regulators can come together and sit at the same table and collaborate on what their decisions are and take joint decisions. The challenge that Canada has is not having a European economic union that has brought all of those regulators to the table.
The United States FDA makes it very clear. They perform their function for the benefit and under the requirements of the United States. They do not perform their requirement for the benefit of Canada. In order to form this type of a collaborative agreement, such as the European Medicines Agency, regulators need to sit at the same table so that there is interdependency. We have not had a suggestion that the United States FDA would rely upon decisions that are taken in Canada in that collaborative sense. While I concur fully that we could be far more efficient and have a greater opportunity to integrate our moderate-sized regulatory function with another set of countries, the challenge is finding that set of countries for us to work with.
The Chair: Thank you. At the very least, Health Canada could make links directly to its clinical trial website to that information so the ordinary person wouldn't have to do a search of the Internet for all the data that you, as an expert, might be aware that you could easily pick up.
Dr. Peterson: I would agree with that fully.
Dr. D'Cunha: I will speak briefly to the area of drug shortages, noting that the current system in Canada is not mandatory; it's voluntary. There still exists the potential for a small-scale manufacturer to choose not to participate, so one doesn't have full visibility.
In contrast, south of the border there are two sites: the U.S. FDA defined bucket of "essential," which is mandatory; and a voluntary collaborative by the American hospital pharmacists association, hosted by the University of Nebraska, which is a counterpart to the Canadian site.
To Perry's point, it's a good idea to also develop clinical alternatives, because on the ground, if there's a shortage of a particular drug, it's important that the pharmacist and the patient are best positioned with clinical alternative decisions. For example, for a drug called propoxyphene in Saskatchewan in November, people on the ground there worked and had ready clinical alternative information available for physicians and pharmacists to work through that particular drug shortage.
Last but not least, Amir, to align with you, we have some good examples in Canada in terms of addressing drug stockpiling. In the area of flu vaccine, Canada has consciously chosen for the last 15 years to always go with two suppliers. There have been a couple of years when one supplier had a production problem. It doesn't matter who. More recently, the Tamiflu stockpile has lessons for us. If we've defined a basket of essential medicines, we can have a one- time investment with regular replenishment so we're always assured of essential medicines being available for Canadians.
Mr. O'Rourke: I have two points, one on transparency and one on the shortages question. I'll try and be brief on both. We all need to continue to push the yardsticks on transparency. We all believe we're being transparent. The summary basis of decision that Health Canada produces is very useful, but they have lots of other information that would be very helpful.
Our agency considered ourselves to be very transparent in the reports that we produce, making everything public, but we started to hear from clinicians and patients that we weren't releasing all of the information. So we put a summary document of the recommendations on our drug reviews on our website. We have massive documents that we produce, both clinical and pharmacoeconomic, that we weren't releasing. It requires a lot of work to put it into a format that is very readable, so we put a lot of effort into that, and we now publish our full reports as well on our website. We all just need to continue to push the yardsticks on transparency.
On shortages, I want to go back to a comment that Amir made. I think he has hit on a point here. To me, the root cause of a lot of the shortages issues goes back to procurement. If you talk to our colleagues in the medical devices community, their major issue is not regulation or patents or health technology assessment; it's procurement. We've had abuses and issues related to procurement systems in government, so we've created very complicated, bureaucratic, technical requirements to procure pharmaceuticals, medical devices and medical equipment. It has not been helpful. I think that pendulum has swung too far and we need to bring it back to something that's reasonable. You almost have to donate a kidney to sole source anything in this country. I think procurement is one of the root causes of shortages.
The Chair: I will allow Ron to put his kidney forward here in a very short input, otherwise he'll lose it.
Mr. Heslegrave: Thank you, Mr. Chair.
The comment I want to make is that we've talked a lot about transparency. I think it's very important to discuss transparency. We all feel better that we're going to have more transparency, but we haven't really defined it and what this means. I'm going to suggest to the standing committee that you might want to consider moving this question to the Council of Canadian Academies. They regularly convene expert panels and charge a number of experts on an expert panel with a way of defining transparency to make sure we can move in the direction of greater transparency and everybody will be familiar with what that means.
A couple of years ago I sat on such an expert panel for defining research integrity in Canada, and it was a rigorous and helpful system. If we're going to have solid definitions of what transparency is, I would recommend that you consider having an expert panel convened through that mechanism that's available to government in order to better understand what we mean by transparency and, in fact, have we got there.
The Chair: You can keep your kidney. Thank you.
There are two aspects that I wanted to put out, and I won't discuss or belabour them. One was there's been a dramatic change with regard to drug shortages, that drugs are supplied in the country in terms of the inventory at the suppliers' level and the pharmacists' level, and there used to be an incentive for pharmacists to have a supply available. I can't remember exactly the length of time that pharmacists had for supply, but there was 180-day supply in there — I think it might have been at the supplier level — with regard to the pharmacy interaction across the country. That gave a buffer with regard to significant changes in that. The incentive for doing that was taken away by provincial governments who wanted to take back every possible dime they could get out of anybody being proactive with regard to dealing with these issues.
The second thing, of course, and it was kind of referred to, is that we are the most balkanized modern country with regard to almost everything in terms of cross-province issues, where every province has a different formulary. Therein lies a significant issue. If you only have one option available on your formulary and yet 10 exist, when a supply situation occurs in that one option, you don't easily have an opportunity to go to alternatives. In other areas where they perhaps have several on the list, they have more of an option. We heard specific input with regard to that aspect.
I'll leave it at that. I'm not bringing it up for further debate.
I will now move to topic 4, which is electronic health, medical and prescription drug records. Jennifer, please.
Ms. Zelmer: I'd like to thank the committee for the previous work you've done in this area and the support you've shown in your previous reports as well.
The first couple of questions you posed were questions of fact in terms of where we stand today on the use of electronic medical records and on the availability of electronic health records.
I thought a handout might be easier with the data, rather than reading a bunch of information into the record. I'll apologize to those of you on the side; I'm not sure I brought enough for everyone, but there are English and French copies circulating. Just let me know if you don't get one.
The short version is: For primary care physicians, last year we reached 64 per cent of primary care physicians who were using electronic records, up from 24 per cent in 2007. For community-based specialists, we reached 53 per cent, up from 28 per cent in 2007. We expect that to continue to grow, given that a number of jurisdictions have expanded or started electronic medical record programs recently.
On the electronic health record side, that was the second part you asked about. As a reminder and information for everyone, this is a secure lifetime record of a person's health and health care history.
At Infoway, we track of availability of six core domains of an electronic health record, things like lab test results or a full medication profile, which is probably most relevant for the study going on right now. The handout shows from our latest report the current status by jurisdiction, where the availability for authorized health care providers stands across the country. If you average that all out, as of the end of March 2014, we were at 89 per cent in terms of overall availability.
The next questions asked were: What other measures are there? Where do we go from here? What's next?
I think we talked a little bit the last time I was at the committee about the fact that availability is an important first step, but then you also need to look at how this information is used in clinical practice and what the end results and benefits for patients and providers are.
In addition to tracking the base availability, we also look at things like what's the use of more advanced functions in clinical practice. For example, our electronic medical record program includes what we call clinical value steps, one of which might be, for instance, if you have access to lab test results or medications prescribed from outside your practice at the point of care or if you are using e-prescribing. We're looking at those kinds of more advanced functionalities as well.
In addition to that, through our new consumer health program, we've also started to look at citizens' access to both personal health information and services across the country.
Continuing on with your other questions, drug information systems are part of the electronic health record. There is an active effort across the country to implement them. As you'll see from the table circulated, complete medication profiles are currently available for all citizens in five jurisdictions and either under way or in progress in the other jurisdictions.
There are active efforts also in terms of pan-Canadian standards in this area through the Standards Collaborative linked to Infoway investments.
That said, obviously standards are a jurisdictional decision based on their needs, and in some cases implementation may vary; for instance, some of the drug systems were actually put in place before the standards were established. We'll have to wait for an update or upgrade before standards can be introduced there.
I think the last part is more Michael's question in terms of the NPDUIS, or the National Prescription Drug Utilization Information System.
The Chair: By the way, I want everyone to know that I didn't tell people in advance who I was going to pick to lead these off, so I'm impressed with how all of them are well prepared coming into this.
I also realize I didn't quite finish off the piece on the supply issue and the storage, where there used to be a significant number of days of supply in the chain. Once the incentive was taken away, my understanding is it has dropped down to perhaps a couple of days or almost next-day delivery, which compounds the problem.
Thank you, Jennifer, very much for starting this off. I'm going to go to Perry next.
Mr. Eisenschmid: Thank you, Mr. Chair.
We certainly applaud the investments and the efforts that have been made and some of the great progress we've been making on a number of these dimensions on the electronic record front.
The issue we face right now is that it's time to move into the next realm with regard to electronic health records. Having come from the private sector, one of my favourite sayings is "you get what you measure." We're hoping we start to move beyond percentage of citizens with a personal health record or percentage of physicians that have electronic medical records. We need to start focusing on why we got into this space to begin with.
The reality is we could have 35 million personal health records, but if they're all built on different systems and platforms and they're not talking to one another, we're really not accomplishing what we had intended.
What we want to start to track and what we encourage the tracking to do is to start looking at what percentage of citizens can take their personal health record, move to another province and have it easily integrated into the health systems there, certainly within their own province, but ideally beyond their own province. What percentage of doctors can prescribe a medication and have it automatically populate the pharmacy systems and the personal health records? Again, not being critical, because I understand why we're there and we are making good progress.
You need that basic infrastructure before you can move on to the next step. I think it's safe to say that the pharmacy community is anxious to move on to this more integrated space, and we're happy to help in any way that we can.
Mr. Gaucher: I'm just commenting on the question related to the National Prescription Drug Utilization Information System Database and whether it's a potential foundation for the collection of data from the drug information systems. First of all, the short answer is we do think it's a good foundation, but I'll backtrack and explain a little bit about the system and why we think it is.
The NPDUIS database holds prescription drug claims data from all provinces in Canada, with the exception of Quebec, as well as one federal drug program. This data is collected using a common data standard. The limitation of it is what it holds is related to what's captured by public drug programs, so it depends on the design of these programs. For the most part, the data does relate to seniors, but some provinces have population-based data as well.
The strength of the data itself is that it is longitudinal data; you can follow patients over time with it. You can potentially link it to other data holdings, which supports further research and analysis with it. When we receive requests for this data from researchers and others, even for our own use, the limitation is that it really doesn't capture the full population of Canada. That's something that CIHI is actively looking to address. This is really where drug information systems come into play.
We believe that drug information systems really do present a potential source for further populating NPDUIS so it does have population-based data for Canada. It is a data standard that is slightly different. Drug information systems are built using a prescription standard that has, from what we know, a little more clinical information. Our data standard in NPDUIS is a claims drugs standard, but from what we know, the standards are fairly closely aligned. With that, we've worked with the jurisdictions previously in terms of aligning their data for submission to NPDUIS and feel that the same type of approach could potentially be used in terms of working with them to bring drug information system data into NPDUIS to further populate it.
Mr. Attaran: What I'm about to say is perhaps an esoteric concern, but I think it has to be taken into account. There is reason to be worried about health information systems being used in such a way so as to restrict civil liberties. This is especially true in a post-Snowden world. While I'm an extremely vigorous supporter and love the idea of health information systems, e-health as it were, I am increasingly worried that we have not given due thought in the health field to how those systems could be misused or put to nefarious use.
We're now in a world where I cannot send an email from my office in Ottawa to my graduate student down the hallway without it travelling via the United States. Literally to get a message down the hallway electronically, it will go through a U.S. server most of the time.
There is now evidence that some health information has been shared by the federal government, with foreign authorities. It has restricted the civil liberties of the person in question.
There was a notorious case of a woman in Toronto who had been receiving psychiatric treatment — I believe it was for depression — and when she tried to enter the U.S. because she was going on a cruise, she was detained at the border and not allowed to enter because the U.S. authorities knew she had been treated for depression. This is awfully frightening, and if all of our medical records are now subject to being shared with foreign governments, either because the NSA is grabbing them or because, as in this case, the federal government voluntarily gave the information to the Americans, we're entering a terribly scary new world here.
I regard it as very urgent that there be legislated restrictions, way beyond what is in today's Privacy Act federally where health information is concerned, so that it cannot be misused by the federal law enforcement agencies, as in giving it to the Americans, so there will be penalties if a foreign agency uses them or so that CSE doesn't make off with them in some way. We don't know the extent of the abuse. We simply know it's there, from this one case.
The Chair: I didn't want to hear all of that, but thank you.
Ms. Currie: I'm glad you used that example. I was writing that down just before you started talking. I think it's a question of who has access to data and for what purpose. I think the public is probably quite skeptical of governments reassuring the public and saying, "Don't worry about your data. We're not going to lose it. We're not going to allow access." There has to be clear legislation that would protect privacy and restrict access, not only in terms of access, for example, to insurance companies or security authorities but for commercial purposes.
I will go back to this later in our discussion about pharmacies. Pharmacists are now requesting access to electronic health records, not only to oversee prescription health but also to lay the basis of providing commercial services to patients. So there's going to be a lot of interest from a lot of parties in terms of accessing these records for a range of purposes, and I think they should be quite restricted.
The second issue is related to prescription drug monitoring and drug utilization data. As a member of the public and as a researcher and evaluator myself, I'm frustrated by the lack of ability to access anonymized data on prescription drug use.
As an example, I'm working with the children's commissioner in B.C. right now because of concerns around the prevalence of off-label prescribing of psychiatric drugs, such as anti-psychotics, to children. It is proving to be almost impossible to get that data. We know anecdotally that 4, 5, 6 and 7 year olds are being prescribed anti-psychotics, so we really want to know what's going on. Why isn't there easier access to that data?
When we're talking about opiate prescription and over-prescribing of opiates, why are provincial jurisdictions having so much trouble identifying high-prescribing physicians? I don't have the answers to that, but I just think that public authorities should be able to access that kind of data more easily and in a more timely way.
Dr. Peterson: In order to answer the multitude of questions that arise in the post-market use of drugs in the real world of the Canadian health care system as compared to how they were studied in clinical trials, you've heard me say this before: The researcher needs better access to better data. But it needs to be de-identified. There's no necessity to drill down to the individual patient level in this regard. However, e-health records will contain far more information than the current data that we have access to, which are linked to administrative health records.
The state of affairs with respect to the Drug Safety and Effectiveness Network is that we cannot respond to the totality of the questions that the regulator or that our provincial drug plans are asking us, because the information that is necessary to answer those questions does not exist in linked administrative health records. We will only be able to find that in the format of a complete electronic health record. It's one of the reasons why data access is such a strong component of the Strategy for Patient-Oriented Research, and the discussions between CIHR and provincial-territorial deputy ministers is very much focused on how we make that data better available.
The provinces vary widely in their ability to release data. We have complete access to the general practice database in the United Kingdom. We're able to purchase that. Therefore, we can get into their records, whereas we have tremendous difficulty and delays of upwards of a year or longer in getting permission to access equivalent anonymized data from our provincial sources of linked administrative records.
In this event, we need to have an integrated national approach to how we can accomplish this, protecting the rights of individuals but nevertheless making this information available.
Ms. Smith: For patients with rare diseases, electronic health records are not only a tremendous asset; they can also be a matter of life or death in identification, management and treatment of rare diseases. I hear your concerns about the safety of electronic records, and we have members who worry a lot about that with insurance reasons for genetic illnesses and things like that. But, for example, for patients with rare diseases, one of the worst experiences is to have to go to an emergency room. I've lived that myself. Having an electronic health record would be helpful there. We're very supportive of a well-managed record and we really do consider it as potentially life-saving for many Canadians with rare diseases.
Ms. Zelmer: I want to follow up on a couple of the comments that were put on the table, the combination of Amir's and others' on the legislative front. Work has been done by the privacy commissioners across the country in conjunction with the privacy authorities within ministries of health, in terms of common understandings for health- information-specific protection. It looks at what are the requirements, how do they feed into provincial and territorial legislation, for which in most jurisdictions there is actually specific legislation related to health information, not just the general privacy act. Many of those are in the process of being updated and renewed.
Underpinning some of that work, and if you are ever interested in delving into it further, is a good deal of conversation with Canadians, polling and focus groups, that brings in the kinds of issues you just spoke about, Maureen, about the balancing act that we do as citizens in our heads between the information for our own care and our public interest as well.
What are some of the things we are looking for as citizens in terms of what would give us more comfort? Some of that is legislative, but a number of the things are not. There is some interesting evidence and information there, if you are ever interested in delving in.
The last thing is just picking up on some of the recent comments in terms of access to information, whether that's for post-market surveillance or otherwise, from the electronic health record. You mentioned the Canadian Academies. There is a Canadian Academies study under way right now on access, trying to deal with some of these policy issues. It's a complex policy environment and that study is trying to disentangle some of those. There may be additional information that would be helpful to you downstream.
The Chair: This is a very important area. We have identified it in each of our studies. We recognize the issue of security of data as a growing concern, as Amir has indicated. Equally, it is difficult for me not to be able to think that we can't conceive a way of dealing with collective information that is depersonalized in a manner that gives us advise on a number of issues ranging from the health issues of the country, on the one extreme, to far better delivery and quick recognition of the issues surrounding treating an individual patient.
For the issue of the incompatibility of systems, it is so frustrating to know how the hospital systems went about providing IT to their areas, and allowed individual physicians in many areas to choose their own operating system so they couldn't even communicate within the same floor, let alone across the system. We had one senior surgeon in Toronto in our health care study who pounded his fist on the table and said, "I don't give a damn if I can't get the information from Calgary. I can't even get it from the floor down below me when I'm in the operating theatre," and pointed out the complexity of the security around what he had to do in order to get into the patient's information in an immediate situation.
We are evolving in these things and moving forward. One of the areas that is actually pushing this is some of the innovative ways that health providers are finding to serve individual patients in their homes. They are actually being quite creative in terms of being able to use the technology in these ways. Ultimately, we have to get the larger collection together in a way that is protected to the degree that it is possible in today's world. The problem we all understand is that with this kind of technology, there are no absolutes. There might be an absolute this minute, and the next minute that situation may change.
This is an ongoing challenge for us all, yet at the same time it offers enormous potential for the benefit of Canadians in terms of protection of their health and the care of their health and as we go forward.
I want to acknowledge again how much we appreciate the tremendous expertise around this table. You are taking time from your tremendously challenging individual careers and opportunities to be here, which is an obvious sign of your interest in this overall issue. We are tremendously appreciative of that.
We will not be able to get out every significant point that occurs to you during this meeting in the remainder of our time. As we do in all our sessions, I will officially invite you to communicate with the clerk. After you leave here, if you have things you think we really should know about, or if there is anything you have heard or didn't hear but that relates to the important topics we have been dealing with, please inform the clerk.
This will be our last chance to develop a summary report, so please do not hold back on anything that you think is important for us to be aware of. We will be taking all of that into consideration. Our report on this will not be written tomorrow; you have time to get it in, but with as brief a delay as possible.
The next section is a collection of adverse drug reaction data. Prior to the break, I asked Janet to start us off on this.
Ms. Currie: One of my favourite topics is the collection of adverse drug reaction data. It is important because, as you know, most adverse drug reactions don't appear in clinical trials often because the trials are very short. They appear after a drug has been tested and approved. Having a robust collection and analysis — I stress the word "analysis" — of adverse drug reactions after authorization is absolutely critical.
In Vanessa's Law, Health Canada is proposing that a signal system be used whereby health institutions be required to report adverse drug reactions. In principle, I don't oppose that method. Health Canada has tried that before with medical products, but I would suggest that it has to be really resourced because compliance among health professionals is poor in terms of reporting adverse drug reactions. So if Health Canada is not prepared to resource this, champion it at the institutions and monitor and evaluate the results, it will not be that useful. That is what happened with the health products approach when they used institutions. They didn't evaluate the data. While on principle I think it is not a bad idea, it has to be resourced, championed and monitored at the institutions.
I would also like to question the other two main aspects of collection of adverse drug reaction data. One is the analysis of large databases provided by industry, which is their most prevalent source of data on adverse drug reactions. I am still not satisfied that the Canadian public knows what criteria is used by Health Canada to identify issues from that database.
I am also concerned that Health Canada be willing to maintain and support patient reporting and health care professionals outside of those institutions, because I think that is a very rich source of data that has been underutilized. There are a number of aspects to reporting an analysis of adverse drug reaction data that are very important.
The Chair: Thank you, Janet.
There are no hands up but I want more discussion on this, so I will pick on Brian for comment.
Mr. O'Rourke: I think I agree 100 per cent. A lot of the issues associated with reporting have been related to very busy clinicians taking the time to sit down to do that reporting, so having the resources in place and somewhat of a behaviour change in reporting.
If you talk to folks in the Canadian Patient Safety Institute and safety committees around the country, it is the same thing. It is all about having that behaviour, thinking about patient safety and trying to fill out these reports. It needs to be a simple, quick, efficient model as well.
You had another question about who should be responsible for analyzing the data collection associated with this. There are probably two aspects to that: Who is accountable for it and who would do some of the analysis? I think Health Canada does need to be accountable for that information. They are the ones that will have the levers in place to do something if there are some strong indicators on a particular medication.
Having said that, I think we all need access to that information — clinicians, patients — and the work we do. It needs to be accessible to everyone who is analyzing that data, but I think Health Canada needs to be accountable for it.
Dr. Juurlink: I think collecting data is only a worthwhile exercise if the data are of high quality and if they are going to be used in a thoughtful way that benefits patients. I have no quibble with the idea that more data is better. It is important to focus on the quality of the data, per say.
I have no real problem with the idea of a patient reporting their misadventure with a drug or their loved one's misadventure. However, it is important to me, if I want to look at that data, that it came from a patient because sometimes what patients report is coloured by their perceptions, and they may or may not be right.
I am a proud Canadian. Each time I go to Health Canada's database, I am a little less proud to be a Canadian because it is an embarrassing thing to use. I have referred to it — probably a bit of hyperbole — as an electronic dumpster, and it is that way. There are nuggets of useful, important data in there, but it is extremely difficult to use and there is lots of noise and things that don't help anyone do anything. It is not clear to me who has issued the report. Is it a pharmacist, a physician, a patient, a patient's spouse? It is not clear to me what happens with the data once it is in the hands of Health Canada.
That aside, I think the idea that hospitals should report is good. It should go broader than that. Physicians on the front lines in their offices should be compelled to report. They should be compelled by law and it should be incentivized. I know that's an easy thing to say and may be a hard thing to do. There are days in the hospital where, I assure you, my residents and I are on my feet all the time and we might take five minutes to grab a bite to eat. The idea that we will spend 30 minutes a file a report, practically speaking, is sometimes a hard thing to do.
One last point is that sometimes we don't know when a patient has had a drug reaction. It is easy; you don't have to be a doctor to know if someone is on a drug thinner and they come in with a massive nosebleed or gastrointestinal bleed that it probably has something to do with their blood thinner. But many adverse drug reactions aren't that way and it's difficult to know whether a patient who is admitted with confusion, fever or a rash actually has those as the result of a drug they've been taking. There is always an issue of incomplete ascertainment. That is why collection of data on its own is not sufficient. These other phase IV initiatives, like many around the table do, are important.
Dr. D'Cunha: To pick up on what Janet and David just said, we have to recognize that the Health Canada database has two sources: health care practitioners or patients and their relatives who have chosen report directly to Health Canada or to the manufacturer who, in turn, only sends serious reactions in Canada and serious unexpected reactions from outside of Canada to the database; and lack of efficacy. The non-serious cases are not uploaded. They are reported on the phone for the updated annual report. Health Canada, recognizing the jurisdictional issues, chose to go after hospitals as the source using the accreditation framework to achieve the goal. I will not comment on the merits or demerits; it is what it is.
As far as the best agency to analyze the data, I am looking at the agency right there, in the form of Dr. Peterson and his agency, because they are sufficiently at arm's length to be able to give credibility to the process. But David's point was well made that if the quality of the data is crap, you will see crap in the analysis.
Ms. Smith: We see the provisions in Bill C-17 as a major step toward collection and analysis of adverse drug reactions. We think that there will be substantial improvement, but as has been stated previously, someone has to champion this. We are concerned about that and involving patient organizations, clinicians, pharmacists and others. We are not really qualified to say who would be best to do this. Is it the DSEN? So far we have not seen the DSEN as being patient or public friendly, but perhaps that could change.
One of our other big concerns is the reporting of adverse reactions for the off-label use of drugs. For rare diseases, off-label use is important because sometimes it is the only drug that can treat the condition. There just aren't any other options. That is an area where we need to do a lot of work. There are not many provisions for reporting adverse events for off-label use of drugs. That puts a lot of Canadians with rare diseases at risk.
Dr. Peterson: I will go back to a previous existence and clarify some of the issues with regard to what Health Canada can do. At the present time the only authority Health Canada has is over manufacturers that require the reporting of adverse drug reactions.
My experience has been historically oftentimes those are line-by-line PDF files with a limited amount of information. They're not searchable. They are very difficult to translate and utilize in that format. Therefore, they need to be translated into a database again.
I can't talk about contemporary issues, but that original Health Canada adverse drug reaction database has been ported to so many different platforms over the years that, in my experience, you could ask the same question sequentially of the database and get two different answers. There are multiple problems with that.
The question is: Should we advise a massive infusion of resources into bringing that up-to-date and reworking that or not? Should the answer be yes, we would still be dependent upon a passive reporting system, with health care providers, patients and others taking the time to fill out the forms and send in the information, perhaps not sufficient information.
Health Canada must rely on the passive reporting system in order to aggregate their adverse drug reaction database at the present time, and then they search that, looking for signals.
The Drug Safety and Effectiveness Network brought another dimension to Health Canada, and that is we have an entire research team that is funded as an infrastructure prepared to have the regulator or the drug plans in the provinces and territories come to us and say, "We would like to see active surveillance of a new product," or potentially an old product on the market. "We would like to see what the experience has been with that product. We will define, along the lines of a criteria-based audit, the actual review of that product as it has been used in the real world." Therefore, Health Canada has been taking many steps to move into a greater active surveillance mode. That by itself does not support a reinvestment or re-infusion of dramatic resources into the passive reporting system.
The other thing that Health Canada relies upon is monthly discussions, teleconferences, with the United States FDA, with the European Medicines Agency, with Australia. It is, as you might expect, a challenge to find a time of day when they would all be on the telephone and participate, but there are monthly reviews of what the other regulators are seeing in terms of safety signals that are arising around the world. Until DSEN came into existence, the Canadian regulator often had to sit and listen to what other regulators had been able to determine. Now, with the opportunity for them to ask us questions, they can sit at that table within that discussion and actually contribute Canadian data, albeit limited.
We're after a distinction between the collection of data versus the accrual of data, and this takes us back to electronic medical records. Rather than the busy clinician, after they complete their entry into the medical record with regard to an adverse event that has happened with that patient, rather than having to then go again and fill out a separate reporting form, we would like very much to be able to access that medical record and be able to search through it and look for the adverse events of interest to us. That in large measure is what we're doing with active surveillance. We're building into the administrative health records those entries that would give us the data on the adverse events that take place.
We're looking more at systems that we can build that allow us to look at the accrual of data in the normal practise of medicine and have the methodology that allows us to do that. By the way, the epidemiologic methods that we support at CIHR are quite powerful in being able to discriminate what is disease experience with a product, disease experience in a patient living with that disorder, versus what may be a contribution of the drug itself.
I'll finish with an overall statement that I hope you'll come back to. It relates to the legislation and the entire discussion we're having.
There is an obsession with just the safety side of the equation. Risk of a new product being introduced into the health care system needs to be evaluated both on the benefit side as well as the harm side. We are very much focused on harms. However, as you've heard from patients before, risk applied to the benefit side of the equation is the risk that you will not derive a benefit from that product. That is the information that we also need to gather and collect and accrue in post-market, real-world experience of the product as well. We're seeing products come onto the market where the number needed to treat in order to get a benefit from that product is one in ten, let's say — ten patients treated and one patient will derive the benefit. That means nine patients out of ten are not going to derive the benefit. That's information we get from the clinical trial.
We need to translate that into real-world experience because in the decision to take a drug — and I think Janet has already made reference to this — if you're going to take a drug, you would like to know what the benefit is going to be and what the likelihood of that benefit is going to be in order to balance this harms equation.
Again, as reference has been made before, if the only thing you looked at in the airline industry was crashes, it might be very difficult to provide confidence that that's a safe mode of transportation. We need to see a greater balance in looking at requirements around real-world identification of benefits and the probability or likelihood of benefits.
Mr. Attaran: I think many people have said that Bill C-17, when it comes to you, is one that should be more or less favourably regarded. I agree with that. For the most part, it's a well-meaning piece of legislation. But I earlier mentioned that there's a serious problem with its criminal provisions. This again rears its head on this subject.
As Robert and David have just said, with adverse events reporting, there are a lot of vagaries. What do you report? When do you report? How do you report? The data formats are a mess. Robert is exactly right. Do you want, in the middle of a lot of vagaries, to apply criminal sanctions? Because that's what Bill C-17 does. Are you, by doing that, unwittingly making criminals out of well-intentioned health care workers? Perhaps. I don't have answers to this. I need to actually look at it and study it more myself, but I want to lay on the table the oddity that in C-17 there were criminal provisions as well as provisions having to do with adverse events reporting. The interplay of those could be a problem.
The Chair: On this point, we heard testimony throughout that this kind of approach to requirement of the practising physician just doesn't work. It puts a fear factor into the clinical treatment environment and the limited experiences where that has occurred have not succeeded.
A number of issues emerge from what you just said, Amir, that suggest that in general that's not a good approach to collecting this kind of data. The issue though, coming to the point you're making, is how do you collect data that really relates? How does the physician know when it is truly an adverse reaction to the drug and not to the other general conditions? I don't want to belabour that right at this moment, but I would simply say we had a lot of testimony relating to the issues that you both raised.
Before I want to go to Janet and then Dr. Juurlink, I want to note that throughout our studies we identified DSEN as potentially a tremendously important player. I'm not saying you're not already an important player, Robert, but as you know, we had made recommendations that you have more opportunity and, indeed, other than the jurisdictions you indicated, that you can take requests from that, there should be a broader range in society that can make recommendations to you as to what could be looked at from your point of view with regard to studies. We feel that your organization can play an increasing role in these very critical areas.
Ms. Currie.
Ms. Currie: I want to get back to the proposal on the table from the new bill, which is that selected institutions be brought into the mix as reporting institutions, which is a new direction for Health Canada in terms of ADR reporting. Again, my major concern is this: Does Health Canada have the resources and the will to actually make this system work? Asking professionals as a whole to compel them to report, I think the compliance level of that is poor. If you resourced institutions and you had the support of people in the institutions to champion reporting, I think it could work. I don't think that Health Canada's record on funding adverse drug reaction reporting support systems is that good, so I am very concerned about the resource issue.
I'm really glad that David brought up the Canada Vigilance Adverse Reaction Online Database. This is our window of analysis on adverse drug reactions. If people cannot use it, cannot make sense of it or it's difficult to make sense of, or the information is not timely, then it is not a useful tool. It doesn't really matter how many resources we have and the amount of information we collect. We have to have it in a usable database that we can analyze; and the public needs to have access to it. The Canada Vigilance Database has been problematic right from the beginning.
I want to close with support for Maureen's comment that adverse drug reactions are very important in off-label prescribing because there is no clinical trial data on the use or the dosage of those drugs in the real world. We're very reliant on adverse drug reaction reporting to pick up signals in off-label prescribing. That's why it's so important that we have robust systems.
Dr. Juurlink: I have two quick thoughts. Bob mentioned that one of the downsides to taking a drug isn't just the direct harms of the drug but the fact that many people will take drugs without deriving a tangible benefit from them. That's very true. Often the number of people you need to treat to prevent a single event is 100 or 200; it's not as low as 10.
Using the kinds of data available now, it sometimes can be quite hard to quantify a relationship between a drug and an adverse event. It's far harder to establish whether a drug helped you to avoid an event. I can measure whether someone got a blood pressure drug or a cholesterol drug, and I can determine whether they had a heart attack or stroke, but drawing the inference that the exposure or lack of exposure to the drug was responsible for having or not having a stroke is a very difficult thing to do.
The last point: I think reporting is important. As I said before, more data is better as long as the data are good and are used thoughtfully. I can imagine a scenario where the reported data would be far less important to the health of Canadians into what we do. It goes like this: Privacy concerns notwithstanding, imagine people like me or people within the Drug Safety and Effectiveness Network or people who had what they felt were important questions to answer had access to every prescription drug dispensed on 30 million people, every hospital visit, every family doctor visit and every vital statistic. Obviously, I can hear the privacy concerns right away, but what an incredibly powerful way to ask and answer important questions. It doesn't exist now.
As I said in my previous appearance before you a few months ago, it's kind of crazy that my kid can go online and play a video game with somebody in Australia in real time, while not only do I not know whether the patient coming under my care today got this drug or that drug but also that I can't study those things with the overall goal of improving the safety of drug therapy.
Mr. Gaucher: I thought I'd share a few insights regarding one of CIHI databases, which has commonality with adverse drug reaction reporting. The database collects information from Canadian health care facilities on medication incidents. This has been in place for three or four years, and we have about 300 facilities from across five jurisdictions that submit data. It's really just to emphasize some of what has been said already in terms of the importance of trying to ensure from the outset that you have good-quality data and that you're really collecting the information that's needed, useful and important, especially for analysis.
Quite often you start out with a very broad data set that everyone thinks is needed and for the importance of really ensuring you do that. It's not just for those analyzing the data but also for those who are actually contributing the data. The burden of data collection as much as patient safety is amongst everyone's highest priorities. It's a challenge, and we've seen that with this database over its existence.
Mr. O'Rourke: I wanted to build on a comment that you made about DSEN and its potential. DSEN was set up to talk about or look at that post-market space, both safety and effectiveness. In the initial timelines, they were getting a lot of queries or questions from Health Canada. We all know, however, that health care is delivered by provincial, territorial and some federal programs, such as Aboriginal, military and veterans, et cetera. Getting that passive information on what's happening on both safety and effectiveness wasn't quite working, and Bob came forward with an innovative proposal.
We've got a really good relationship with the provincial drug plans. He has funded a staff member in my organization to actively seek information from those provinces about putting resources towards moving from a passive system to an active system. I think we'll start to see some real benefits of that moving forward.
The Chair: We weren't aware of that specific action, but it's that kind of attitude recognized in his various appearances before our committee. We think there's a great opportunity for further contributions through these innovative approaches. This has been very good.
Under the next section, the role of pharmacists, some things that have occurred in the discussion to this point may re-emerge.
Mr. Eisenschmid.
Mr. Eisenschmid: Thank you, Mr. Chair.
There's clearly increasing recognition of the important role pharmacists can play in Canada's health care system. That may stem from the fact that pharmacists are convenient, have 9,000 locations around the country, and are often open 7 days a week, 24 hours a day. The professionals are very competent. They have many years of university education, specifically in the field of pharmaceuticals and related issues and practices. As well, they are cost-effective. When I say "cost-effective," I mean that from a total cost-effective perspective such that patients don't have to travel as far; can travel when it's convenient for them; pharmacists are at the front line, so they're often able to early diagnose issues like hypertension and put in place effective treatment before it leads to more severe and costly impacts further down the line in the health care system; and they're valuable members of the broader health care team so they know who to connect patients to in the broader health care system.
We're happy as the Canadian Pharmacists Association that this move is taking place. Nonetheless, it's not happening as fast as we would like it to. There's clearly a place for a greater role for pharmacists in the provision of health care in Canada; and the health care innovation working group is increasingly recognizing this.
As well, we would suggest greater uniformity of role across the country. Mr. Chair, you were commenting that we have some of the largest obstacles within our country in terms of various issues related to this field, and practice is no exception. In Alberta and Saskatchewan, where scope of practice is very broad for pharmacists, it meets right across the border to Manitoba, where there's very limited scope or at least compensation for the scope they practice. We would love to reach a point where patients can cross borders and expect the same level of service from the pharmacists serving them.
Finally, we would look towards the federal government to lead by example in this area with the populations they serve, such as Aboriginals or military. The federal government is one of the largest providers or funders of these kinds of services in the health care system, but tends to lag compared to what the provinces are funding. Those would be our three recommendations on that.
The Chair: Thank you.
Senator Eggleton: We heard about environmental concerns at a couple of our hearings with respect to unused pharmaceuticals, products that can frequently find themselves going down the toilet or into the landfill through garbage disposal if they're beyond the date or just unused for whatever reason. We also heard that in some places pharmacists will take in the medications. I understand that can generally happen here, but what about a very high-level campaign to try to get people to do that so that we can prevent that kind of stuff from getting into our environment?
My second question has to do with the pharmacists' role in the drug shortage issue as to both identifying the alternative drugs but also alternative therapeutics.
The Chair: With regard to the first question, can you make any comment with regard to that national day of drug disposal?
Mr. Eisenschmid: I can. First of all, you're absolutely correct. I think most pharmacies across the country would accept unused drugs in their pharmacies and dispose of it in an appropriate manner. Outside of that, we are in discussions with Public Safety Canada and some other Canadian organizations to create such a national day of drug disposal. We're more than happy to support that kind of effort.
Because you shouldn't have to wait for an annual period to make this happen, broader public awareness of the fact that if you have drugs that you want to dispose of, bring it to your local pharmacy and in most cases they will be able to take care of that, as opposed to storing it yourself for the national collection day. But we would support that as well and I think that would also aid in overall awareness.
Do you want me to address the second point?
The Chair: Yes.
Mr. Eisenschmid: On the drug shortage front, your questions were about what role we can play.
Senator Eggleton: The role you are playing or improving the role you can play in terms of therapeutic alternatives or alternate drugs.
Mr. Eisenschmid: We do and can play an even greater role in terms of the therapeutic options with drug shortages. As I mentioned earlier, we received significant funding from Health Canada some years back to create therapeutic choices, which is a comprehensive tool to allow health care practitioners to understand what their options are for any particular issue that they're dealing with. That is currently broadly available. I think the biggest opportunity is to make it more available in the integrated health systems. Right now it is available as a reference tool. Ideally, to make it convenient for practitioners, it would be embedded in the electronic health records, the hospital records, so that it is easy for them to access and obviously have all the benefits of electronic access. That would be the one enhancement we could put in place.
Dr. Juurlink: We actually put a paper in CMAJ a month or so ago on this issue of taking drugs back. I would make the point, although it sounds kind of odd, the idea of flushing drugs down the toilet isn't actually that bad an idea. I guarantee you the amount of drugs that end up in the water supply from human waste is vastly greater than that which could possibly end up from flushing some tablets down the toilet. But it's an important issue because people save drugs. They save them because it's the easiest thing to do and they save them because they might want to use them again in the future. Sometimes that's okay and sometimes that's a dangerous thing.
From a pharmacy perspective, I practised for five years as a pharmacist and I agree very much that pharmacists have a greater role to play than they do presently. I think the single most important thing that can be done to advance their role is to empower them with data.
We talked last time I was here about what happened in British Columbia when PharmaNet kicked in and the tremendous decline in double-doctoring for opioids and benzodiazepines. That's courtesy of the access to data, which is I point I made before.
One last quick point: You mentioned alternative medicines. I'm not sure what you meant by that, but I don't think pharmacies should be in the business of selling things like homeopathy, and they are. That doesn't do anyone any good except the people who own the pharmacies and sell the products.
Ms. Currie: I'd like to inject a cautionary note about expanding the role of pharmacists. I realize it's a very popular concept and I certainly do not dispute the importance of the skills of a pharmacist and the health care team. But I think we should disabuse ourselves of the notion that community pharmacies are like mom and pop stores down the street in our neighbourhood. They're huge conglomerates. The Katz Brothers in Alberta have 1,500 pharmacies. You're looking at Loblaw, Sobeys and Walmart. These are huge profit-oriented institutions. Drug selling is the name of the game and pharmacists are the vehicle for drug selling. They may offer valuable services, but they are part of that system.
Do we want health professionals advising patients on what drugs to take and what drugs to substitute who are working in a profit-making context? I think that's a conflict of interest and we should be very wary of that fact.
I think also that the expansion of the role of pharmacists in terms of diagnostics testing has implications we may not have considered. Pharmacists do not have the training a physician has around, say, a personal medical exam, and yet they are making drug recommendations on the basis of limited laboratory testing.
The range of services that pharmacies are now suggesting they can offer has cost implications to our health care systems. For example, in Alberta last year, the billings made by pharmacists to the public and private health care systems doubled in one year for services such as medication planning, medication review and medication substitution. The suite of services will cost us something and there is profit motivation behind it. I just think we need to have a sober second thought about the role of the pharmacists, considering the context in which they work.
The Chair: The latter, that's us and that's partly why we're here.
Mr. Attaran: I just want to respond to a point that Perry brought up.
I understood you to say that one of the directions you'd like to see the profession of pharmacy move in is a more national sort of profession where provincial boundaries matter less. I do have one great concern about that. I think you can only harmonize at a national level if all the provincial colleges of pharmacy share a common ethic. Unfortunately, it's today the case that they do not. Some of them are more ethical than others, to be very blunt about it. The case that comes most readily to mind is how the different provinces have dealt with Internet pharmacies.
Quebec and Ontario, to a lesser extent, have moved to enforce laws on Internet pharmacies only selling approved medicines. But in Manitoba and British Columbia there's an epidemic of licensed pharmacies and licensed pharmacists who are in the business of selling to foreigners medicines that are not approved by Health Canada; medicines that, for example, include products from India that have never been vetted by Health Canada, from Zyplo or from Sun Pharma, which is the company acquiring Ranbaxy — an outright criminal company. There are products by those companies for sale by Manitoba and British Columbia pharmacists today.
This is a problem because it amounts to essentially a small number of bad actors in the pharmacy business deliberately violating the law. They even sell products such as Vytorin, which is a Merck product but not approved by Health Canada. It's never been approved in this country.
My concern is until you get to a common ethical standard among the provinces, any sort of harmonization is just off the table and breaking the law is, of course, the least common denominator of what is not ethical.
The Chair: Perry, I will have you limit your response to that right now because I want this to come back in the next section under "security." This is a major issue in that area, so please limit your response to that aspect at this point.
Mr. Eisenschmid: I just wanted to respond, first of all, to the point brought up earlier down here. We clearly need to separate the commercial interests of the pharmacy from the profession operating within that context. We even have different associations representing those different needs.
I understand that a pharmacy, as a business, is a big business in its totality, with all of the other things it is servicing. Nonetheless, the pharmacist operating in that environment is a health care professional and, though every profession has its bad apples, operates in the best interests of his or her patients.
On your other point, what I was expressing was a vision that is one that would benefit everybody in Canada. There are impediments to reaching that, and uniformity of ethics within colleges would be just one of the examples. This broader group is looking at those impediments and those things that need to be done to address those.
The Chair: Before we move on to the next section, Amir, please be patient; I will ask David Juurlink to start this one off. This topic is the security of the drug supply, unless you would rather pass that on. I'm not going to get you to start right now; I want to make a couple of comments on the existing one.
For the benefit of the assembly here, other than the general knowledge of the important role of pharmacists, we became aware of their important role when we studied Canada's response to the H1N1 pandemic. One of the most obvious areas of the role of pharmacists is that, at that time, they were arguably the most IT successful group in the country in terms of certain aspects of data.
It turned out that certain pharmacists were aware that there was an emerging flu epidemic occurring prior to any official recognition of that because of the number of prescriptions for Tamiflu and other issues related to a an influenza epidemic. This was simply filling prescriptions that had been written by doctors for that issue. Their database had shown an uptick in this area.
The issues that are bound around concern for safety are tremendously important. Yet, if you look at just the collection of data on the number of prescriptions filled and where they are prescribed, for example, with opioids, there is no question that in a given area the pharmacists collectively have absolute knowledge of how much oxycodone and its various forms are being prescribed. The use of that data in total avoidance of any personal connection could be tremendously important. Again, these are examples.
There is the correct concern, where you have to separate profit motive from professional motive, at the extreme of one end. At the other end, there is data that can be completely neutral in terms of the ethical implications for particular individuals but tremendously important to the health care system with regard to the overall impact on the health of Canadians. The opioid issue is just another example.
Over the course of our studies, we have become increasingly aware that pharmacists, through this kind of data availability and the fact that they are linked in various ways with broader knowledge of this total prescription issue can be a tremendous asset to the health care system, just in that area alone.
Without delving into the prescription of drugs, I think we recognize that this is an area where one has a multitude of possibilities, and we must not overlook those things that can be done quickly and securely as we move into the more complex areas.
With that, I would like to move us into the security of the drug supply. This is an area that we delved into in our last study, so you don't have a report from us yet on this. That draft report is in progress. However, it was under the rubric of the study that was unintended consequences. This is an area that we think is tremendously important, and we wanted to hear more from a broader group with regard to this issue.
I will go to David, first, to introduce us to this.
Dr. Juurlink: I didn't realize you were going to, but now that you have given me a bit of a head's up, I don't know a lot about the security of the drug supply before it gets to the pharmacies. I do know that it happens, from time to time, that drugs — and we are talking here primarily about drugs prone to abuse, like opioids, stimulants like Adderall and Ritalin and sedatives like Valium and that sort of drug — are occasionally intercepted or stolen from pharmacies before they even get to the patients. No one is pedaling Lipitor on the corner.
It occurs to me that the sales data, the amount of OxyContin, Fentanyl or whatever you want to think about that is being delivered to an individual pharmacy, is tracked somewhere by someone. I don't know exactly by whom. Perhaps someone else in the room does. I suspect those data are not utilized as well as they might be. For example, if you knew that a pharmacy in Timmins was receiving five times more oxycodone than the pharmacy around the corner, it seems to me that that might be a sign of something worth looking into. Again, I don't know who has those data. I do know that as a pharmacy student in the late eighties, someone came to our pharmacy. We had a narcotics registrar, and she came to our pharmacy and looked at our records. It was all manual. It has to be a much more efficient enterprise now.
From a prescribing data perspective in terms of enhancing the effectiveness of the tracking, and I hate to sound like a broken record, but more data is better. IMS collects data, and I can tell you that in Ontario we sell, per capita, three times more oxycodone than they do in Manitoba. That is probably the result of us paying for it more readily than they did, but the data are there. I think it is unfortunate, though.
Just an anecdote: I had lunch last year with a young man who was a recovering opioid addict. He spent 13 years of his life abusing opioids and didn't pay a dime because he got every single prescription from a physician and got it filled at a pharmacy on the public plan. He collected huge amounts of drugs. Someone clearly paid for it. In the process of paying for it, they collected that information, and for more than a decade these data resided somewhere and weren't analyzed by anyone, including the people paying the bill.
I think that prescription drug monitoring programs, which are implemented to varying degrees across the country, are probably the best way to ensure the security or to track the misuse of these drugs. I don't think they are as developed as they could be. I think privacy concerns would be one of the reasons.
In Ontario, there is a new narcotics monitoring strategy. You would think that if someone went to Dr. Juurlink tomorrow and got a prescription and then went to another doctor on Monday and got a prescription for Fentanyl, the second pharmacy might have a flag raised. That is not the case. You have to go to a third physician, which again makes you wonder about the design of these things and the extent to which privacy concerns, as important as they are, undermine our ability to do the things we are supposed to be doing.
Senator Eggleton: One of the concerns — and this came out from the Aboriginal community particularly — was this whole matter of the generic version of the original painkiller and its replacement of Oxycontin. The problem is that the generic version apparently has some of the narcotic problems that the original one had. I understand that many provincial health ministers have asked that it not be allowed, but Health Canada has allowed it. Do you have any thoughts about that issue, as well as the whole question of the much higher use, in terms of statistics, in the Aboriginal community?
Dr. Juurlink: Maybe I will tackle the second part first. In Ontario, we've looked extensively at the prescribing of these drugs and mortality from these drugs. The part of Ontario that has by far the highest rate of death from opioids is Manitoulin Island, which is largely populated by First Nations people. The prescription of drugs there in our database isn't as high as it might be because their prescriptions are paid for federally as opposed to by the province. I can't really study that issue as well as I might because the data collected aren't available to someone interested in studying it.
With regard to the first part of your question, you're referring to OxyContin specifically and the issue that arose after Purdue, the manufacturer of OxyContin, changed their formulation. They made it tamper-resistant, which is not to say it can't be abused — it very clearly can be — but it wasn't crushable in the way the old one was. You couldn't crush it with a credit card and snort it, as that young man I mentioned often did.
I think a case can be made on both sides of that equation. I think a case can be made that generic OxyContin is a rational product in the sense that it's less expensive than the brand-named product. From a public-health perspective, it's not the kind product that we need. We need fewer prescriptions for these drugs than we have. Not to look in the rear-view mirror too much, but we for sure need better data. These drugs get on the market and are prescribed to almost 20 per cent of our population because of studies that look like this. They take relatively healthy people with pain who are relatively free of risk factors for abuse and diversion, give them these drugs or placebo for 12 weeks and measure some pain score, a surrogate outcome that is of no value to the doctor on the front line or to the patient.
No one has ever done a study that looks at these drugs and compares them to other pain relievers and says, "Hey, these make quality of life better." Do they offer benefits that offset the risks and so on? Perhaps I'm going on a bit of a tangent.
The response of the federal minister to this issue was, as I recall, that she didn't have the ability to refuse the application of the various generic companies that brought them forward. I'm not a lawyer; I don't know about the details of that. But it seems to me that if anyone should be able to stop a product like that, it should be the federal Minister of Health.
Mr. Attaran: Thanks, David. That was interesting to listen to.
On the security of the drug supply, I've talked about a different aspect of it than what you just mentioned. Really it has to do with drug crime. What's happened in the last two decades is that the business of medicines has become globalized. We buy medicines, whether we know it or not, that come from all countries of the world. It used to be that they were made more locally: made in North America at least. Now they are very likely to come from India or China. For the most part this is a good thing because international trade drives prices down and gives us access to products that we wouldn't otherwise have in some cases because we don't have manufacturing capacity near us. For the most part it's a good thing.
But, of course, anytime you have international commerce, close on its tails you'll have international crime, going back to the few bad actors that always exist.
Lately this has come to the fore because there have been a number of high-profile cases, particularly of Indian pharmaceutical companies, that have deliberately cheated, for example, by fabricating the test data that they used to gain approval for their product. That's a problem, because if we are going to make use of foreign medicines more frequently than we have in the past, we want to know that that does not come at the cost of safety.
What's unfortunately true is that Health Canada has not adapted its processes to deal with this new globalized reality. One of the things that Health Canada said when it came to your committee, chair, was that for imported medicines they generally rely on the importer to do the testing of the quality. This is true. So a medicine that is imported from, say, India or China, in most cases — not all cases — will have its quality vouched for by a consultant hired by the importer. This is not the typical way of doing things in other countries.
In the European Union, every imported batch of medicine, every batch that comes from not a developed or advanced country is tested. We don't do that here. Instead, we rely on the importer of the medicine to do that testing, so of course there is an apparent conflict of interest. If you are the importer of the medicine, would you hire a consultant who says your medicine is garbage? It's not very likely that you would do that.
This is a case of not, by the way, a legislative problem. The practice of relying on the importers to test their own is not in the Food and Drug Regulations; it's not in the Food and Drugs Act. It is actually a practice, guidance, of Health Canada. I think this needs to be re-evaluated.
The question is: Is it for the Senate to now mandate that through legislation to actually give this a legislative framework that it now lacks? Is it better simply to talk to the agency about reforming its guidance? I vote for legislation on this.
Mr. Corman: Before I make any comments, I would like the group to know that for over a decade I was personally involved in the manufacture, registration, importation, testing and distribution of pharmaceuticals and devices in Canada. I have personal, hands-on experience with the system and how it works. Prior to that, I was in the pharmaceutical industry, heading the marketing department of a multinational. I would like to talk about the kind of data that's available, right down to individual physician-level data to elaborate a bit on David's comment.
There's one missing piece we haven't talked about, and that's the role of the drug wholesaler, the intermediary between the manufacturer, distributor and the pharmacist. To me, that's a pretty big fish that slipped through the regulatory net, and we need to address that, perhaps not today, but we need to look at the role of the pharmaceutical wholesaler in the security of the drug supply.
Having imported finished goods, pharmaceuticals, raw materials and components from places like Mexico as well as the United States and the United Kingdom, the system is a good one. Where it breaks down, potentially, is in the testing.
There is a requirement for all drugs imported into Canada to undergo quality control testing against the specifications, never mind the whole registration process before that. The testing can be done by the importer or manufacturer in his own laboratory, or it could be outsourced to labs like SGS. Another area I think the committee should look at is the role of clinical laboratories and other laboratory services in this whole scheme. There is a role for them, and I think it needs to be examined.
Believe me, Health Canada's inspectors, when they inspect, ensure that every batch has been tested in accordance with good quality practices and that it is from a reliable source. I don't think there is a need for new regulations. I think there's a need for more robust inspections and also a certification that any laboratory that's used in testing complies fully with good laboratory practices. My answer is let's ramp up the inspections with more and better-trained inspectors to ensure the rules are being followed properly.
With respect to the data that's currently available, there is data available right down to the individual physician level on what drugs they prescribe for what indication and how much of it. Pharmaceutical companies are presently buying that and they make it available to marketing departments and sales representatives.
Similarly, there's another report based on hospital and pharmacy. They know what's being sold and how much to hospitals and pharmacists right around the country by product. I would love to be able to get that kind of data more accessible so that regulators — let's call them the referees — policy-makers and decision makers are at least as well informed as the drug companies.
Maybe we don't need to reinvent the wheel. Maybe we need to figure out a way to get data that is already available used in a better way for the benefit of society and not just the drug manufacturers.
The Chair: Jack, I want to make sure I heard correctly one comment you made. I think you said that "Health Canada, when it inspects, does a good job." Is that what you said? Did you mean to imply that it inspects everything that comes into the country?
Mr. Corman: No. It doesn't; it can't. It's simply not possible given the resource constraints. I would also like to draw a distinction between the GMP, good manufacturing practices, inspections and the GCP, good clinical practices. Clinical research, clinical trial inspections I think are night and day in terms of quality.
Focusing on the GMP inspections, by and large they are good. They are focused; they are intensive; there are lots of good questions — and manufacturers are put on the spot, as they should be — but there are not enough of them.
I would also like to see the extension into inspection of laboratories where these tests are being done. If it is part of a manufacturer, then that comes under the GMP of that manufacturing facility and so the inspection typically incorporates that as well. But if one was using an independent facility like SGS, I am not sure who is inspecting those facilities, and I think they should be brought within the regime. I think we don't need new legislation to accomplish that.
The Chair: I understand what you've said and I wanted it very clear for the record with regard to the totality of inspection versus the inspections that are actually carried out.
Mr. Corman: You can be sure you will be inspected.
One other element that people need to know about if they do not already is the establishment of the licensing process. It is a two-step process. One is that if you are going to make a drug somewhere, or be the deemed manufacturer, you have to apply for an establishment licence, which is a pretty robust process. On top of that, you have to apply for a licence to make a drug in a particular location. If you don't have both in that same facility, you can't make a product, no matter how good your facility is. To me, that is one of the reasons why our drug supply is at risk, because of the evolution to an ever-tighter restriction on where pharmaceuticals can be manufactured, even if it is the greatest plant in the world. That might be something, again, that we should explore at another time.
The Chair: I want to come back to this issue of inspection. What the Ranbaxy situation shows is that even one of the best regulators in the world was fooled by inspection, and the issue of inspection in that country comes under the laws of that country.
Mr. Corman: That's not what I am talking about. I understand that. I have followed that; I followed some other things as well, but in Canada —
The Chair: Well, it's important for us to know your comments in perspective because that is part of the totality of the supply of drugs in Canada.
Mr. Corman: Right, so that is why the FDA has established offices in places like China and India; they are conducting more robust inspections.
I believe we are correct in this country, and one of the justifications to maintain Health Canada, as much as I have certain things I could say in another direction, is I think that's a critical function for Health Canada to ensure that every single shipment of foreign-made pharmaceuticals, whether finished goods, raw materials or work-in-progress, gets inspected here in this country by a credible and qualified inspection service, subject to inspection by the regulator. I think there should be, and I think there already are, substantial penalties if you fail to follow that process, including removing your licence as an establishment.
Senator Eggleton: I don't know what penalties are being put out in this particular case, but Ranbaxy was found guilty of a crime, fined $500 million, and many of their medicines were removed from the market in the United States and have been in Europe. Yet 159 medicines from Ranbaxy are still available today in Canada.
The inspections that have been carried out by Health Canada are minimal compared to those of the United States. When you get such organizations as the World Health Organization estimating that one in five drugs made in India is fake, there is reason to be very concerned here about public safety.
Mr. Corman: I understand. I've worked in international pharmaceutical circles. As well, I've looked at importation of drugs from places like India and bid on international contracts, and I can tell you some countries will refuse to entertain bids from Indian pharmaceutical manufacturers for those very same concerns.
My concern isn't so much the fact that there is cheating going on in foreign jurisdictions because we don't have the reach to be able to dig down and go there the way, perhaps, an FDA can. My concern, first and foremost, is how we ensure that what we have available here in this country is safe.
I just was reminded of one other thing. Health Canada has the right to inspect for cause. If a particular manufacturer is under suspicion because of wrongdoing in a home country, I see nothing stopping Health Canada from ramping up two things: One is on-site inspections of importers of drugs that are manufactured by that manufacturer in that other country to ensure that all the necessary testing has in fact been done and done properly; and, second, removing test products from pharmacy shelves to independently test them. Health Canada already does that. Again, I see no reason why we can't embark upon a targeted program when there is a high index of suspicion to ensure that we have good, safe drugs for sale in this country rather than a broad-brush approach.
The Chair: I can assure you we asked direct questions in this area, and the answers we got were not reassuring. On this particular point, Amir, and then I will move further on the list.
Mr. Attaran: Part of the problem is — and I agree largely with Jack — we can't exercise the reach as a middle size country that the FDA can to station inspectors in India, say, nor do I think we should, by the way, because that essentially would amount to Canadian tax dollars being used to provide regulation for Indian companies to profit. That is exporting jobs at that point, right? I don't even think that is the right answer for the U.S. for that reason. What we could do at the very least is make the penalties for cheating meaningful.
Senator Eggleton, you are exactly right. When Ranbaxy pleaded guilty to fraud in the United States, it faced US $500 million in civil and criminal penalties. Someone who deliberately, knowingly, flagrantly, with knowledge sells an adulterated medicine in Canada is subject to — are you ready for this — a $5,000 fine. We have a problem with our law.
Mr. Corman: I understood that was per day, that it can be cumulative. That is what I was told. I may be mistaken.
Mr. Attaran: That is incorrect. In section 31 of the Food and Drugs Act it is $5,000 per count. I suppose a prosecutor could charge each count by each day, but that is not what is normally done, and I am not even aware of anyone being fined $1 much less $5,000.
Even if one were to use Canadian law to the maximum, its penalties are inadequate, and in the testimony of Health Canada to your committee at the end of April, that was said by Dr. Sharma, that the penalties are inadequate. That is one thing she said that is truthful and helpful.
You will need to address this and you have an opportunity to do so in Bill C-17 since it specifically targets amendments to section 31.
Dr. Peterson: My comments were related to prescription opioid abuse. I don't know whether you believe that we have moved on from that in the interest of time.
The Chair: No, get your comments in. I want to get the comments in. You can make further comment on the opioid issue, absolutely. That is a major issue we identified as an unintended consequence in our study.
Dr. Peterson: CIHR has received envelope funding from Health Canada to specifically address issues around prescription opioid abuse, and the Centre for Addiction and Mental Health has established a nationwide network now that is prepared to facilitate research in this area. In addition to that, we have received, through the Drug Safety and Effectiveness Network, a query from the drug plans specifically addressing generic OxyContin versus the newer OxyNeo. There is a large differential in price between the two products.
Their question was complicated, but it distills down to whether there is value to the Canadian health care system to pay the higher price for OxyNeo compared to generic OxyContin. Again, we will be able to answer that question specifically. However, you begin to lose track of what the overall objective is. If the overall objective is to reduce misuse of prescription opioids, you can't focus just on OxyContin, despite the fact the news media have and it is a product that has been addressed. Eighty per cent of prescription opioid abuse is for short-acting opioids, not continuous release.
We've had the additional problem in Canada whereby our minister has been contacted by the FDA wondering why we approved generic OxyContin. We know what the minister's answer to that was. Irrespective of that, the United States did not permit generic OxyContin to come onto the market in favour of the tamper-resistant OxyNeo.
As a parenthetical note, OxyNeo is very effective in preventing the crushing of the tablet, adding water to that and allowing it to be injected because it forms a gel. However, in the course of our study, we have found that a high-quality coffee grinder will take OxyNeo just fine and create a sufficient powder so it can be inhaled or snorted, using the vernacular.
Technology notwithstanding, we'd like to address the question: What are the appropriate steps we can take to reduce prescription opioid abuse? It will certainly not be focusing on one product. In fact, at the same time the FDA was raising questions with our minister, they approved the sustained release hydrocodone product as hydrocontin. That product happens to be three and a half times more potent as an opioid than oxycodone, and they did not require a tamper-resistant form of that.
We are attempting to address our questions here, irrespective of questions that may be prevalent in the media as to what appropriate steps Canada can take in order to reduce prescription opioid abuse.
The Chair: I want to make sure we get on to antibiotic resistance. I will ask if anyone has a different aspect of security of the drug system they want to bring up. If they do, I'll recognize them. Otherwise, I'll get into antibiotic resistance.
Ms. Currie: There are a couple of points here. I think whenever you have an opioid problem that is affecting the public, it is due to over-prescribing in general. It's an indicator of over-prescribing. When you have prescription drugs sold on the street, that's another indicator of over-prescribing.
I think there are a number of factors. In Canada, I think we may have a low threshold for pain management. Certainly you've heard many anecdotal reports of people being given OxyContin for what I would consider something that could be managed for a couple of short days with Tylenol with codeine and then written off. I think there's an over-medicalization of pain.
I think even looking under that layer, we can't forget that Purdue Pharma, the manufacturer of OxyContin, had a deliberate strategy for marketing its drug. If you look at the history in Newfoundland — it's quite well researched — they targeted small, rural pharmacies. They pushed the drug. They minimized the addiction effects, and they were found criminally responsible for that. They didn't go to jail, but they paid hefty fines.
I think one has to look beyond the reasons why there is the over-prescribing of opioids.
I also think there are other drug classes, such as benzodiazepines, which have serious addictive qualities. I've tapered many people off benzodiazepines; it is an absolutely gruelling, heart-rending process, and it takes months. It is harder to get off benzodiazepines for most people than it is to get off heroin.
I think we have to look at all those issues if we're going to deal with the problem.
Mr. Eisenschmid: The CPHA has supported a national process of narcotic surveillance and control and believes the Controlled Drugs and Substances Act should be amended accordingly. I'm going back to some of the comments made across the table earlier.
We've also spoken out against allowing generic OxyContin to be made available in Canada. I'm just supporting the points made earlier.
The Chair: Thank you.
Before you start, Michael, I'll indicate to Dr. Peterson that I'm going to tap him for any comments first on antibiotic resistance in the next section.
Mr. Corman: One comment we haven't addressed is on the security of opiates.
The Chair: I'll come to you then, Jack, if it's a different issue. I have two on the list, and I said that at the end of that, I would ask for additional comments.
Mr. Corman: I apologize.
The Chair: I'm just alerting Robert to the next stage. We're not there quite yet, but thank you.
Mr. Gaucher: I just want to comment on the data. There have been comments about data that's held in pharmacy systems perhaps by organizations. I think it's important to think about the purpose of the data in determining which data might best fit a particular situation. For example, prescription drug monitoring programs use data in pharmacy systems because they're targeting more patterns with prescribers and particular individuals and may collect additional data on their own. CIHI's drug claim system may be beneficial, for example, if pan-Canadian trends are being looked at.
I believe there's a lot of data out there, and there's a lot being collected within provinces and by other sources. I think it's just really trying to determine what purpose and if there is value, for example, to looking at some pan- Canadian trends in some of these areas in addition to what's being done at the provincial level.
Dr. Juurlink: This issue of opioids has been a major preoccupation of mine life for the past couple of years now. I have a bias, but I think it's the most important drug safety concern we face today. I think if we are going to make a dent in it — actually, before I make that point, I'll make the corollary point that I think it's fortunate that the DEA, the White House and the CDC are working together, but I think it's unfortunate that no one in our federal government, to my knowledge, can tell us exactly how many people died last year from opioids. In the U.S., you can easily find statistics that will say about 16,500 people died of opioid-related causes. As far as I can tell, there isn't a single person, from the minister on down, who can give us a corresponding number in Canada. It's on the order of 1,500. I don't know. It's a lot of dead people, a lot of tombstones, yet nobody knows.
If you wanted to make a dent in this issue, I think the single most important thing that can be done is for physicians to write fewer prescriptions. There are articulate people who will disagree vehemently with that, but I think it has to be done and there are different ways to do it. One of them is education. I think physicians need to be told that much of what we were taught about opioids was wrong. We were taught those things in part by the pharmaceutical companies that make these drugs and their agents.
In 2012, a Senate investigation in the United States was launched. It has not been published yet; the results haven't come out. Charles Grassley and Max Baucus initiated an investigation in March or May of 2012, intending to uncover exactly how much money exchanged hands among Purdue, Endo, Cephalon and other companies in the States that make these drugs and where that money went, going back more than 10 years to not just key opinion leaders who helped promote the use of these drugs but to special interest groups, pain foundations, patient groups, the American Geriatrics Society and so on. I think that investigation will show hundreds of millions of dollars of money used to notionally promote the better treatment of pain but really to promote the sale of these drugs.
That has never happened in Canada. I can give you tangible examples whereby manufacturers of these drugs gave misinformation for free, in the form of a textbook, to pharmacists and medical students. There are doctors practising around Canada who hold incorrect beliefs about OxyContin, for example, because of what they've been taught. No one has ever done anything similar to what the U.S. Senate is doing in terms of investigating why.
I've often wondered why it is that a drug company can infiltrate medical schools with its agents, people who have been paid six figures, if not seven, to speak for these companies. They don't declare their conflicts. They promote the use of these drugs in ways that are completely unrealistic and actually say things that are false, and these people are now writing prescriptions based upon what they were taught. It warrants more exposure than it has gotten.
The Chair: This issue is one that came up throughout our studies with regard to even the general education of physicians about dealing with pain, and we have serious requests that this be recommended as an important aspect of medical training in that we had clear evidence that in many cases there are non-addictive alternatives to opioids. This was a very important part.
I'm going to move to the question I said I would put to you. Is there an additional issue?
I want to note that Amir put on the record the issue of Internet pharmacy. We had a lot of testimony on that before our group. It's not just as simple as a Winnipeg pharmacist selling the material. There are Internet sales of prescription pharmaceuticals that claim to be based in locations in Canada but which, in fact, are not. We had testimony of the security offices with regard to these issues. That particular one is on the record for our meeting here today.
Mr. Corman: I believe the FDA publishes names of physicians who have been caught violating prescribing standards for opiates. That feeds into the transparency debate. If you haven't done so — and I'm sure you have — you need to bring the Colleges of Physicians and Surgeons into this process so that they can effect robust oversight of prescribing, which I know some do, and physicians who are disciplined for over-prescribing, that information is made public. I think that could help.
The Chair: Jared, you had a different issue.
Mr. Rhines: I wanted to address Dr. Juurlink's comment around pharmaceutical behaviour and remind the committee that we are governed by a specific code of ethical practice that dictates how we engage with all physicians. There have been bad seeds in the past. We've all experienced that in our own fields. But our industry is governed by very strict code of ethical practice that prevents some of the behaviours you're referring to that may have happened in the past.
The Chair: I'm going to move to antibiotic resistance and ask Robert to provide some comments here.
Dr. Peterson: Quite clearly this is a very large area of research interest and of concern. The Government of Canada, through the Canadian Institutes of Health Research, invested $15.3 million in 2012-13 to help invest in research in this area. The reality is that antimicrobial resistance is not a national but an international issue. The resistance is the resistance of microbes, bacteria and other infectious agents that travel across the globe readily, given today's society.
As a consequence, the investment by the Canadian Institutes of Health Research has largely been an international collaboration. Canada is leading collaboration between the United Kingdom and Canada, looking at supporting innovative research in antimicrobial resistance. That investment was approximately $7 million. Canada belongs to an international consortium called the Joint Programming Initiative on Antimicrobial Resistance, which has 19 member states that are engaged in that.
The solution to the problem will be an international one. The issues associated with how rapidly microbial organisms will become resistant to new agents is not a question of if they will but a question of when they will. Therefore, appropriate prescribing behaviour is important in that regard.
Within Canada, clearly, at the provincial level, where health care is delivered, there has been a good deal of activity with respect to appropriate or inappropriate use of antibiotics for non-bacterial infections, such as the common cold, and raising awareness for that. Unfortunately, I believe that reviews of antimicrobial agents demonstrate that there still remains a good deal of prescribing of antibacterial agents for common colds and viral infections that is inappropriate.
The investment that we're making involves both strategies that will be effective in translating into practice the knowledge that is gained through research, but, as well, to look at how one can achieve a reduced amount or frequency of microbial resistance by virtue of combination therapies, et cetera, that we know will be successful in reducing the emergence of resistant strains.
My only contribution to the table is that one should not have a lens just on Canada. One needs to have a lens internationally on this and measure the effectiveness of a Canadian approach to AMR by virtue of the degree to which Canada is working internationally in this respect.
Senator Eggleton: I certainly agree that there needs to be an international approach, but actions are already being taken.
One of the most alarming statistics out of all of this is that in the United States they're saying approximately 80 per cent of the antibiotics are consumed in agriculture and aquaculture for the growth purposes of these animals, and that that is contributing substantially to the resistance. I believe the European Union has banned or is in the process of banning the use of antibiotics in this form. Is that something we should be advocating here?
Dr. Peterson: I'm not sure I'm qualified to answer that question because you're now going into the area of agricultural and veterinary use of them. There is no question that we have known for a long period of time that we begin to see emergence of resistance strains in animal populations where the same antibiotics are used broadly in that environment.
The issue with regard to banning their use is I think part of the international discussion now. The World Health Organization has clearly targeted this as perhaps the major challenge of the 21st century, as we may be moving into a post-antibiotic era which will be equivalent to the pre-antibiotic era that we experienced. I can only concur that your comments are accurate. It's more than just the issue associated with the medical use of antibiotics; but, once again, this has to be done on an international level in order to be successful, based upon the ready transfer of resistant strains across national boundaries.
Mr. Eisenschmid: I think this is an area where pharmacists can, via the expanding role of pharmacists, play an important role. The expertise of pharmacists can be leveraged to ensure that antibiotics are being prescribed only when needed and that the most appropriate antibiotic is being used in a specific condition. That's both upon dispensing of medications and with periodic medication reviews.
Mr. Rhines: I wanted to add to Dr. Peterson's comments that I think this is certainly a cross-border effort; but I would argue that it's also cross-sectoral. This is a complicated issue that requires public and private cooperation. I think it requires some look at policy initiatives.
We know other jurisdictions have begun to have discussions around policies that foster the development and encourage antibiotic development for serious infections. The U.S. has a law since 2012 that provides incentives for development of antibiotics.
It's a cross-border issue for sure but also requires a host of stakeholders, academia, researchers, industry, government — everybody — to begin to address this issue completely.
Dr. Juurlink: It hasn't happened to me yet, but it's probably only a matter of time before a patient of mine dies because of an infection that I don't have an antibiotic for. So I agree with Bob and others who have said this is a global problem.
From a Canadian perspective, what can we do? We have two options, I suppose: Do something or do nothing. I think none of us would think that doing nothing is the right thing to do.
Under the heading of "something," education is the number one priority. I don't know anything about antibiotics in the food supply. It sounds like a bad idea. I don't know what the upsides are. But education of the public in particular — there is a certain societal expectation that when you have a problem and you go to the doctor, there will be a drug for that problem. That includes sore throats, fevers and flu-like symptoms. I think doctors are less likely now than they were 15 or 20 years ago to give a patient an antibiotic for something that clearly doesn't warrant it; it's probably a viral infection. It still happens. It happens because the doctor makes the assessment that it probably won't hurt the patient and maybe if it's bacterial it will help, but you do that 100,000 times and you're creating a huge problem.
Educating people is important. We have no reluctance to educate people about the importance of not drinking and driving, or of buckling up or of using sunscreen. I don't know that we educate people enough about the importance of taking antibiotics or seeking them for everything they think might be infectious.
Ms. Currie: I haven't seen recent data on the off-label prescribing or incorrect prescribing of antibiotics, but it's still very high, I think; 40 to 60 per cent of antibiotic prescriptions are inappropriate or off-label and inappropriate. Physician education is obviously a really important key here.
I concur with your concept that we need to look at all sources contributing to antibiotic resistance: the overuse in meat and other products; and the overuse of antibacterial products in the marketplace, soaps, cleaners, the contribution of those products as well.
In terms of public education, I've seen some very helpful PR announcements on when to use an antibiotic when it's appropriate. The missing piece for me is that people do not understand how long viral illnesses can last. The usual scenario is that you get a cough that goes on for five days, then you go to your doctor and the doctor prescribes an antibiotic, whereas a viral cough can last three weeks or more, and that is normal. It's within the normal range. Along with the "don't use antibiotics for a viral illness," there needs to be more education about how long things can actually last so that people have a more realistic approach to viral illnesses, especially when their children are concerned. As a parent of four kids, my kids have been sick from October to April, non-stop, but with viral illnesses. Parents don't have a realistic view of how long it is. It's depressing, but it's realistic.
Mr. O'Rourke: I would agree with David that a really good public awareness campaign would be necessary. Physicians know that there is antibiotic resistance. They know not to over-prescribe for viral infections.
One of the other aspects at the other end is that we do need new antibiotics to have these antibiotics for that third or fourth line. How do we incentivize the pharmaceutical industry to create a new antibiotic when we're going to tell them we're not even going to use that antibiotic until the fourth or fifth line? We do probably need to look at a different model for incentivizing the development of new antibiotics.
Dr. D'Cunha: I'll make my comments in two sentences, chair. I would say collaborate and work globally, but already start to implement locally. The local implementation should be a comprehensive strategy, not only building on what you've already heard, but do take on the animal piece, please.
Mr. Corman: I would like to propose consideration of a national strategy on infection control. I think the typical pattern is that most serious infections start in the hospital. That's where the resistance is seen. Then there's a pattern where it moves into the community.
Over the years I've been involved in the pharmaceutical industry, one way or another I think there has been a deterioration in the robustness of infection control, driven by pressure on hospital budgets. It would be really helpful if we could have enough money to ensure that really vigorous infection control measures are implemented right across the country.
The Chair: I'm going to bring this to a close. We have identified this as a very serious issue and one that is already upon us and is going to continue to emerge as a huge issue worldwide. It involves not only the resistance of currently well-known bacteria to the arsenal available but the continued emergence of new pathologic bacteria, organisms, that require us to look further.
It is clear, and it's clearly recognized internationally and beginning to emerge — the United States is taking a lead in this area — that we have to engage the private sector, the research enterprise, to identify this as a clear area of focus. They've introduced their new qualified infectious diseases product regulations and a product has already emerged under this area, where there's increased granting of time of protection of the new area. They're deliberately incentivizing activity in these areas, and the World Health Organization, for once, I think is actually in front of something real. They have made this a very important issue that they're dealing with worldwide.
Those of us who are my age know what it was like as kids, and the fear that parents had if you got a simple scratch, let alone something more serious. You knew of situations in your neighbourhood where people did die from infection of wounds, and the problems in hospitals, which were even more serious.
We have become comfortable in this critical area because of the enormous success of pharmaceutical research over the decades, and now we are, as Robert said, potentially in a post-antibiotic era, which will be serious.
I want to close this off by thanking you all very much. I want you to know how much we appreciate your taking the time to come to this. It's clear you recognize this as a very important area. We respect that. I hope we have reflected and will continue to reflect in our reports the seriousness of these issues that you have brought before us.
A quick comment on one of the issues: I was really disappointed to hear that clinical trials are actually declining in certain areas. We've got to turn that around. One of the objectives was to turn around the decline of clinical trials in Canada. We tried to emphasize in our report that clinical trials are important to a country in a number of ways: maintaining highly qualified, educated expertise in studying pharmaceuticals, potential new medicines and so on; being able, after a clinical trial, to advise the country on issues that arise post-approval, let alone the huge economic value to the country and the maintaining of industrial activity within the country. This is a critical area.
If there are further thoughts you have after you leave here with regard to things you would like to tell us about how to continue to improve in that area, that's one area I want to request your input, and also any comments that you have. We didn't get much into what people think about some of the things that are moving forward with regard to clinical trial groups that are coming together to work to harmonize things in certain areas. If you have any thoughts on that, please, because that's a starting point to all of the things that we discussed around pharmaceuticals. They don't get to be pharmaceuticals unless they go through clinical trials and it's important for all kinds of issues.
I know that we are likely to see some of you back here when we get Bill C-17 before us.
I am pleased to hear the recognition that we have to move forward in this country. This bill may not be perfect at this stage, but by golly, we have to get somewhere further than where we've been. We will try to give advice on that.
I can tell you from my own experience that I find the current minister and her immediate group to be very receptive with regard to input on issues that range from transparency to others. I am hopeful that we will get a lot of good discussion on that bill and some positive impacts.
It then remains for me to ensure that we end on time and we get to our planes and other things. I'd like to thank my colleagues, who have been very patient today. We love to ask questions. That's what we do. We try to get those questions in common to send out to you, and you have responded tremendously well to us. The clarifications have been enormously helpful.
I want to thank my colleagues for their role throughout this whole series of studies. It is not necessarily the sexiest or the most politically correct kind of thing that political environments can get involved in, but I believe it is one of the important areas of society. In the end, I hope we will have made a contribution to the evolution of developments in this area.
(The committee adjourned.)