Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 34 - Evidence - March 20, 2013
OTTAWA, Wednesday, March 20, 2013
The Standing Senate Committee on Social Affairs, Science and Technology met this day at 4:14 p.m. to study prescription pharmaceuticals in Canada (topic: Off-label use).
Senator Kelvin Kenneth Ogilvie (Chair) in the chair.
[Translation]
The Chair: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.
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My name is Kelvin Ogilvie, and I am a senator from Nova Scotia and chair of the committee. I will ask my colleagues to introduce themselves, starting on my left.
Senator Mercer: I am Senator Terry Mercer from Nova Scotia.
Senator Enverga: Senator Tobias Enverga from Ontario.
Senator Seth: Asha Seth from Ontario.
Senator Seidman: Judith Seidman from Montreal, Quebec.
The Chair: Thank you, colleagues. I would like to remind everyone that we are in our current study of prescription pharmaceuticals. This is the third phase of a four-part series. In this particular study, we are dealing with the off-label use of pharmaceuticals. We are pleased to have some very distinguished witnesses with us today to represent various sectors of the industry and to bring their knowledge to this very important issue.
By prior agreement, we will begin with Andrew Casey, President and Chief Executive Officer of BIOTECanada.
Andrew Casey, President and Chief Executive Officer, BIOTECanada: Thank you very much. On behalf of the member companies of BIOTECanada, I greatly appreciate this opportunity to contribute to the committee's work today in the important, timely study of prescription pharmaceuticals and today's focus on off-label prescription medicines.
BIOTECanada is the national trade association representing the full spectrum of biotechnology innovation in Canada. BIOTECanada's 250 members include both the large health biotech companies and small start-up companies striving to bring new biological medicines through the regulatory system, with the aim of improving health care outcomes for patients across this country.
In the context of today's meeting, the Auditor General's 2011 report highlighted the challenge of ensuring the regulatory process is in step with the rapidly changing pace of scientific discovery and the corresponding need for Health Canada to adapt its structure and tools required to provide timely and appropriate information to serve the increasing demands of patient care in Canada.
Canada is not alone in this regard. As diseases, corresponding therapies, medical devices and medicines evolve and increase in complexity, health care regulators around the world — including the U.S., the U.K., the EU, Australia and many other countries — are also striving to keep pace with these developments and innovations.
Canada too must address the implications of modern technologies and the need for improved mechanisms to share information and to better work with the vast amounts of data now available. A changing environment and rapidly shifting demographics are placing unprecedented pressures on the Canadian health care system. Innovation and leading research in Canada and other parts of the world are leading to significant health care advancements.
In the world today, there are almost 1,000 biologic-based medicines in development. More will emerge. They bring the promise of treatments and vaccines for a range of disease and illness, including cancer, coronary disease and diabetes, to name but a few. Where we have had treatments for cancer in the past, some of which have been quite successful, we find ourselves in a position today where vaccines for cancers and biologic medicines are having some experts forecasting a world in which cancer will no longer be a death sentence but rather a chronic illness. Managing these discoveries and bringing them into actual care regimes for parents is a driving force for BIOTECanada members.
Biologic medicines are complex systems designed to interact with our entire human system. The specificity involved in each biologic medicine brings with it the need for a separate regulatory process. As knowledge of these biologic systems grows, thanks in part to a vast amount of research generated as a result of the mapping of the human genome, so too are the options for improved, more personalized methods of health care for patients.
Given the complexity and rapidly evolving nature of biologic medicines, BIOTECanada welcomed and has contributed actively to the consultations led by Health Canada with respect to the legal and regulatory modernization initiative.
This consultation process called to the forefront the opportunity to incorporate within the Canadian health regulatory system with up-to-date information about the system of drug discovery and development and to help ensure that the regulatory process is able to function at 21st century-levels of operation.
With more than two years of LRM work and part of the consultations already completed, BIOTECanada and its members are fully engaged in realizing the outcomes of this process, which will help to ensure that the Canadian regulatory regime is fully updated. The need for regulatory capacity to grow and adapt to the reality of scientific discovery today is a must for Canada.
The process is already offering significant results, as we see in the case of rare diseases where the Minister of Health announced last year her intention to create a pathway for treatments for rare diseases, most of which affect children, thereby filling a gap in the health care system in Canada.
There are very limited options for patients with rare diseases to seek courses of treatment in Canada. The regulatory pathway that the members of BIOTECanada have been working to secure for more than nine years will bring Canada up to speed with both the EU and U.S. regulators, ultimately allowing for improved treatments where, currently, there are very few or, in many cases, none.
The LRM consultations with Health Canada have provided an opportunity to establish how this data collection, management and analysis is structured and to determine how it can best be used by Health Canada in performing its regulatory responsibilities.
What has become evident is a need for structural change and improved linkages between the various groups within the regulatory body to benefit from the volume of data companies now have at their disposal.
Biologic medicines are extremely complex and powerful tools. As a result, the biologic regulatory process in Canada is an extremely robust and diligent regime of analysis and comparison applied to each and every product. It can take up to seven years or more before an approval can be had and a marketplace earned. For every one product successfully brought into medical practice, nine will fail. Years of scientific scrutiny continually take potential medicines or treatments out of development. It is one of the greatest challenges companies face as they seek to attract investment and design clinical trials. It is simply part of the reality of trying to bring new, safe and effective medicines to patients.
With the ever-increasing demands of more exact and effective health care delivery, the convergence of knowledge found throughout the spectrum of care for patients is an increasingly integral component in the advancement of Canada's health care system. For this reason, an important policy objective for government will be to effectively extract the knowledge off-label use brings and to ensure the best possible care for patients through safe and effective medicines.
In conclusion, BIOTECanada encourages the committee to express its support for the legislative and regulatory modernization process currently under way and to support measures that would enable Health Canada to enhance its regulatory capacity to review and approve safe medicines for use in Canada. In particular, the consultations should continue to involve the entire range of stakeholders, including the biotechnology industry; medical practitioners, including physicians, nurses and pharmacists; IT technology providers; and, of course, patients. All represent important parts of improving health and patient care for Canadians.
Again, I thank the committee for this time, and I look forward to its questions.
The Chair: Thank you very much. By agreement, we will hear from Rx&D next. We have two people representing them: Jared Rhines, Scientific and Regulatory Affairs; and Walter Robinson, Vice President, Government Relations.
Walter Robinson, Vice President, Government Relations, Rx&D: Thank you, Mr. Chair and honourable senators. It is a pleasure to be back with you here at the committee. We look forward to informing this phase of your work in off- label prescribing and utilization as part of your broader comprehensive study of the role of prescription pharmaceuticals in Canada. Rx&D represents Canada's research-based pharmaceutical companies.
[Translation]
The innovative medicines and vaccines that our industry researches, develops and delivers represent some of the most advanced, safe and effective medical treatments available. They help Canadians live longer, better and more productive lives.
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These technologies also ease the burden on the health care system by avoiding more costly hospitalization and invasive surgical procedures. When appropriately prescribed and adhered to by patients, the use of innovative medicines is a critical component of ensuring the long-term sustainability of our cherished health care system.
In addition, the 50 members of our industry association continue to play a leading role in Canada's innovation and knowledge-based economy. We account for some 46,000 jobs across the country, invest over $1 billion each year into R & D activities and contribute $3 billion annually to the Canadian economy. In fact, we are the largest private sector funders of health research in Canada, with over 75 per cent of our R & D investments going into some 3,000 clinical trials that are presently under way in every province and region of this country.
We are also an active partner with stakeholders in Health Canada's legislative renewal and modernization, LRM process, as Andrew Casey mentioned before me. This initiative will modernize the Canadian regulatory landscape for the benefit and safety of patients. It includes the recent and, may I add, most welcome issuance of the draft orphan drug regulatory framework for medicines for rare diseases and conditions. This framework will allow for a formal regulatory pathway for orphan drugs and their indications. We remain committed to working with Health Canada and other stakeholders throughout the LRM process.
Turning to the issue at hand today, as other witnesses have already stated before you, off-label use refers to the use of medications for indications that have not received regulatory approval from Health Canada.
[Translation]
As you have already heard from pharmacists and clinicians in oncology, mental health, pediatrics, geriatrics and ER settings, for example, off-label use is a common practice of health care providers based on clinical and scientific evidence and usually made in consultation with their patients.
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Before going further, it is important, if not fundamental, to refer to the first day of testimony you heard last spring, during phase 1 of your work, from Paul Glover, ADM at Health Canada. Health Canada reviews new drug submissions from our industry on the basis of safety and efficacy. This rigorous review depends on a thorough scientific and clinical data package. The scope of any drug approval — a notice of compliance, or NOC — is granted, in very specific terms, through a product monograph and label.
Furthermore, in accordance with Canadian law and Rx&D's Code of Ethical Practices, it is illegal and forbidden for our members to engage in any commercial activities that promote off-label use of medicines or vaccines that deviate from the Health Canada approved monograph and label.
[Translation]
I will repeat in French that it is illegal and forbidden for our members to engage in any commercial activities that promote off-label us of medicines or vaccines that deviate from the Health Canada approved product monograph and label.
[English]
As you have already heard from previous witnesses, it is the health care provider who is responsible for prescribing medications. Off-label prescribing, as you have also heard, is an increasingly common occurrence in fields such as oncology and mental health. Off-label prescribing is not only for different indications but can also occur via a method of administration, be tailored to an age group or subpopulation or even occur through adjustments in dosage strength or frequency.
Moreover, the ability for health care providers to prescribe in this manner is a long-established practice of medicine. It is about being guided by best judgment and informed by clinical and scientific evidence to find the best treatments that work for one's patients. As committee members are well aware, our member companies are global in scope and have various functions, including scientific inquiry, regulatory approval and marketing departments. Clinical research, as this committee has heard extensively, is governed by its own set of legal, regulatory and ethical requirements. It is legitimate scientific inquiry to explore the safety and efficacy of existing products for additional indications or populations. At no point is this scientific and clinical research work inconsistent with the clear prohibition of off-label promotion by a product's manufacturer.
To conclude, off-label prescribing by health care providers is an important part of both the practice of medicine and the advancement of applied, bedside scientific knowledge. It ensures that health care providers have the ability to provide the best treatments for their patients, based on clinical practice guidelines, accepted research and, ultimately, their professional judgment.
From an industry perspective, however, we must always be vigilant to place our obligations in the correct context. Canada has clear and strong regulatory, legal and ethical guidelines that prohibit the promotion of off-label uses. These rules should continue to be vigilantly enforced, as long as all parties are clear about the respective roles and responsibilities of the health care provider, Health Canada, academic and clinical researchers and, of course, ourselves as product manufacturers. If the Government of Canada decides that these rules need to change or evolve, Rx&D will work collaboratively with all stakeholders involved in this process.
[Translation]
Thank you for your attention; I look forward to your questions
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The Chair: Thank you very much, Mr. Robinson. May I clarify something? I do not know how your pages work out, but towards the end, you referred a moment ago to Canada's clear and strong regulatory, legal and ethical guidelines. Are those not regulations?
Mr. Robinson: Some are regulations, some are guidelines.
The Chair: You are referring to guidelines and indicating they are also regulations?
Mr. Robinson: Yes. Thank you for the clarification.
The Chair: I was sure that was the case, but I thought I would just clarify that.
Mr. Robinson: Thank you, senator.
The Chair: Thank you very much. Now I will turn to David Windross, Vice-President of External Relations, Teva Canada.
David Windross, Vice-President of External Relations, Teva Canada, Canadian Generic Pharmaceutical Association: Thank you, senator.
The Chair: I should also indicate that you represent the Canadian Generic Pharmaceutical Association.
Mr. Windross: Yes. Thank you, honourable senators, for inviting the Canadian Generic Pharmaceutical Association to appear as part of your study on the off-label use of pharmaceuticals.
Teva Canada Limited is the largest generic pharmaceutical company in the world, and Teva Canada is the second largest generic company in this country in terms of sales.
Today I am speaking on behalf of the Canadian Generic Pharmaceutical Association.
In terms of my own professional background, I have 38 years of experience in the health sector, including 17 years as a hospital pharmacist where I practised at hospitals in the Toronto area, being the Toronto General Hospital, the Princess Margaret Hospital and the North York General Hospital. For the past 21 years, I have worked in the generic pharmaceutical industry, first with Novopharm Limited and now with Teva Canada Limited.
The generic sector of the pharmaceutical industry is very competitive and has helped Canadians enjoy affordable pharmaceutical health care for more than 50 years by offering high-quality medicines at substantial cost savings over brand name equivalents. The greater use of generic drugs is one way to save our health care system money while preserving the level of service in the health care system to which we have become accustomed.
Today, generic medicines offer savings of 70 per cent to 82 per cent over brand name equivalents. In fact, in 2012, the generic pharmaceutical sector saved Canadians over $8 billion in medication costs through the introduction of a number of new generic products and the ongoing savings generic products provide to the Canadian health care system.
There are no differences in quality, purity, effectiveness and safety between a generic medicine and a brand name medicine. The active ingredient in a generic medicine and a brand name medicine must meet the same scientific norms and standards set by Health Canada, and the generic manufacturer must prove that the product is as safe and as effective as the brand version.
All medicines sold in Canada, brand or generic, must be approved by Health Canada. Each medicine must also meet the strict regulations established by the Food and Drugs Act on an ongoing basis.
A generic drug is granted market approval and a declaration of equivalence to the similar brand product. Health Canada applies very stringent requirements to the approval of generic products in order to determine the bioequivalence of the product to the original brand medication. The principles of bioequivalence and the science of pharmacokinetics are utilized by regulators around the world, including Canada.
The safety profile and approved indications for a medicine can be found in its product monograph, which you have heard about many times throughout your deliberations. These are the on-label uses for a medicine and reflect the uses approved by our regulator, Health Canada.
The initial product monograph is developed by a brand name drug company in consultation with Health Canada. When generic companies are preparing to launch a new generic medicine, they too work with Health Canada to develop a product monograph for their product. In practice, however, the product monograph is virtually identical to the brand monograph for all bioequivalent molecules. The exception is where a particular indication for a medicine is protected by a patent. In that situation, that particular indication would not appear on the product for a generic medicine until the expiry of that particular indication patent.
From an industry perspective, all pharmaceutical companies are prohibited under the Food and Drugs Act from selling and marketing a drug for off-label uses. While brand name companies educate doctors about their products in the hopes that they will issue prescriptions for the approved uses of their medicines, generic companies typically do not interfere with doctors and instead focus on having a pharmacy stock its product over the bioequivalent medicines provided by other generic competitors.
As you have already heard from earlier witnesses, off-label prescribing of pharmaceuticals is widespread within the medical community. It is particularly acute within certain populations, and you have heard from earlier witnesses about the challenges of conducting trials in these populations.
While off-label use raises a potential concern about safety and the amount of scientific evidence available to support a given off-label use, practitioners have also testified that it offers some benefits to patients and to the health care system. When talking about CGPA's position, off-label prescribing can play a role in therapy, but it is up to the medical professional writing the prescription to ensure there is a strong evidence-based rationale for the off-label use of a medicine that is being provided to a patient. A pharmaceutical company can only go so far in the information it provides to prescribers, information that is limited to the approved indications for that drug.
The practice of medicine is a science that relies heavily on information, not only from suppliers — whether it be pharmaceutical manufacturers, medical equipment suppliers, medical or surgical suppliers, et cetera — but from their peers, whether they be in an active practice or in academia. Likewise, the interaction between health care professionals is much more important today, in particular with professionals such as pharmacists and nurse practitioners.
Pharmacists are the experts on drug therapy and therapeutic alternatives, and there is a potential role for pharmacists to work to monitor as well as alert physicians to off-label prescribing and to provide guidance. Such practice is particularly prevalent in the hospital pharmacies and no doubt will become more commonplace in a community practice as the role of pharmacists changes from that of a product focus to a more clinical and patient focus.
We would support initiatives by medical experts, including doctors and pharmacists, to put in place programs to improve prescribing practices and information sharing.
Some witnesses and committee members have suggested that incentives should be provided to pharmaceutical companies to conduct studies for new uses of a medicine. While CGPA is willing to examine different options, we would not support any policies that delay the entry and use of generic medicines. Such delays would raise costs and hinder patient access to our lower-cost medications at a time when the Canadian health care system is cash-strapped and straining to afford necessary services.
In closing, thank you once again, honourable senators, for inviting the generic pharmaceutical industry to appear before you here today. I would be pleased to answer any questions you may have.
The Chair: Thank you.
Senator Seidman: Mr. Casey, if I could start with you perhaps, you say before your recommendations that an important policy objective for government policy will be to effectively extract the knowledge off-label use brings and ensure the best possible care for patients through safe and effective medicines.
There is no question that that is the objective, to ensure safety for patients who are taking these medications. We know that there is much off-label prescribing and it is of much benefit.
My question to you is this: How do you think we could effectively extract the knowledge off-label use brings?
Mr. Casey: I think you have a number of streams that come in, not only from Canada but from around the world, so you would want to capture all of that data, add it to the existing data coming out of clinical trials and fold it together into the department. It is also important that within the Department of Health, the various divisions collecting that data are also talking and working together so that data is put together in a cohesive form so it is actually usable going forward.
Senator Seidman: One of the issues that you and Mr. Windross raised concerns information sharing for practitioners. That issue has come up often during these hearings. Clearly that is something we would like to facilitate.
How would you see that information sharing happening in your ideal world?
Mr. Casey: I cannot speak for the practitioners or the physicians, but I know what I have seen from the Auditor General's report, which pointed out that a number of different departments are collecting the data and they should be doing a better job of coordinating the collection and use of that data.
Senator Seidman: In your recommendations, you encourage the committee to do several things. One is to express support for the legislative and regulatory modernization process currently under way. Is there something that you would like to highlight about that process that you think is particularly important?
Mr. Windross: What is particularly important, and this goes to your previous question, is that the process bring to the table all the different stakeholders and key players involved at all levels of this. Obviously, there are the manufacturers as well as the physicians, patients and nurses. The entire spectrum should be at that table to help develop a framework that will keep safety and effectiveness in mind.
Senator Seidman: I understand.
Mr. Robinson, you referred to Stan Glezer, who appeared before the committee on the post-approval monitoring phase of this study. He said something interesting when he was here. He said that progressive licensing would allow for labeling changes throughout product life-cycle based on their emerging evidence. Could you elaborate on that? Did you find that to be particularly interesting?
Mr. Robinson: There are various things in the context of progressive licensing or coverage with evidence as clinical science abounds and grows. I was here but I do not remember the full context of his remarks. He was appearing on behalf of Rx&D. I do not know how much further I can go there.
As more data are developed, manufacturers will apply or conduct a trial for another indication. Progressive licensing is another way to get to that point of view, which is being used in some jurisdictions or to get to approved indications in other jurisdictions. It is one of the options or tools that regulators working in concert with industry have at their disposal to provide the best therapies to patients, if they are proven to work.
Senator Seidman: Thank you.
Senator Mercer: Gentlemen, thank you for being here; I appreciate your time.
I will try to combine my questions to all of you in one or two short questions. Mr. Windross, you said that off-label prescribing of pharmaceuticals is widespread within the medical community. We then go over to Mr. Robinson who talked about the fact that it is illegal and forbidden for the members of his organization to engage in any commercial activities that promote off-label use of medicines and vaccines that deviate from Health Canada's approval.
I want to go back to the beginning. What are we doing wrong here? There are medical schools, nursing schools and pharmacy schools. Are they not covering this when people are being trained, whether they are scientists, nurses or doctors?
Mr. Windross: Thank you for that question. If I understand correctly, to clarify the point that was made, and that I made as well, a pharmaceutical company cannot advocate the off-label use of a product. They cannot market, have literature about, "detail physicians" about or put on continuing education functions for prescribers about the off-label use of a pharmaceutical. It is clearly forbidden and clearly not done.
However, from a practitioner's perspective, the practitioner being a physician, pharmacist or nurse practitioner, to read the literature in terms of what is happening with a particular product for off-label use, to speak to that particular product to students, for example, or to talk about certain molecules, realizing that we have a product — a molecule or drug — and we have the pharmacology of that drug. Through experience in using that particular drug, the pharmacology of the drug becomes enhanced — that is, what types of actions happen with this medication. Is it what the textbook says or do other things happen? Are there side effects, which might not be deemed poor or adversarial side effects but might be good side effects for the treatment of another disease? All of that is happening in academia and in practice, et cetera.
In the world of hospitals and grand rounds with physicians and medical grand rounds, et cetera, these types of things are discussed and relayed to students, residents and interns. We need that distinction. We have a commercial side in what we are licensed to sell and what we can talk about; but there is also the science of the drug. All of these medications are based on pharmacology.
Senator Mercer: As well, there is the practice.
Mr. Windross: The practice takes off from the pharmacology.
Mr. Robinson: If I may add, there is a continuum in that we have laid out the roles and the legal responsibilities incumbent upon manufacturers to abide by the Health Canada approved indication, label and product monograph. Through years and decades of practice and scientific discovery as it relates to health care providers, physicians, prescribing pharmacists, nurse practitioners and dentists, the scope of practice or prescribing continues to increase across the country. They learn and read international literature and national literature, and attend medical conventions to learn about the different medicines being used. Sometimes those will go through clinical trials to get an approved indication.
I can tell you a personal story. You asked, "What are we doing wrong here?" I would disagree with the premise. There are clear bounds on what behaviour on behalf of industry is wrong as laid out in the Food and Drugs Act and in our code of conduct. I have a 15-year-old son as the result of a clinical trial of a cancer medicine that my wife took. It was found to have a positive side effect in hyper-stimulating women in IVF in egg production. A clinical trial conducted on an off-label use has given me a 15-year-old boy. As some of you may have seen across the country, we are running My Life My Medicine advertisements. If you have been at Gate 17 at the Ottawa airport waiting for a flight to Toronto, you have seen a variety of patients there. One patient, Tannis Charles, had rheumatoid arthritis and suffered through it for 20 years. She could not lift her own child when that child was born. She found out through a clinical trial that a cancer medication had beneficial impacts for her rheumatoid arthritis. She has told the story before parliamentarians in the other place that she can now pick up her grandchild. It is a continuation and a growth of medical research. Our roles are clear, as I pointed out in testimony.
It is important to know that if this committee or the Government of Canada is looking to make recommendations or changes, we as an industry stakeholder want to be at that table to improve things. We are all united in the context of the best medicine for the patient at the right time in the right dosage for the right treatment; and the interest of safety must be paramount.
Senator Mercer: Mr. Casey, you were kind enough to provide us with recommendations. Your second recommendation is to support measures that would enable Health Canada to increase its capacity to enhance its regulatory capacity to review and approve safe measures for use in Canada.
What are some of the specific measures?
Mr. Casey: You are entirely correct in that it was a general statement. Do I have specific measures to recommend? The department has signaled and the AG report signaled that there is a requirement for additional finances before the capacity of the department can grow. Maybe that is one area.
Certainly, when we work through the process of the LRM, it will help identify certain areas where the department can benefit from additional capacity. How you get there would be another discussion; you are entirely correct.
If I might pick up on that last bit, I would say it is not so much a question of what are we doing wrong, but maybe there is an opportunity to do things right. With the evolution of medicines and the diseases and illnesses that are taking place at such a rapid pace out there, I think everyone has acknowledged that they are occurring at such a pace that we have an obligation for patient care and to do things right. The important part of what the AG has signaled to Health Canada is to grow their capacity.
Senator Cordy: Thank you for your input today. It is certainly a challenge looking at the issue of off-label drug use. I feel like I am in a quandary because we hear about the off-label use and that there is not necessarily scientific data to go along with it. On the other hand, we hear about the off-label use in subgroups — particularly pregnant women, seniors, those suffering from poor mental health, and today someone mentioned oncology — where we do not necessarily have the data and it would be difficult to get it. No pregnant woman would want to undertake clinical trials of a drug while she was pregnant, I think.
We know that off-label use can be wonderful, Mr. Robinson. You gave an example that we all use, which would be baby Aspirin for good heart health. We heard from doctors who appeared before us that the evidence they have is word of mouth, which is not a bad thing. When I asked the question of whether someone was dealing with children, we heard that children's hospitals actually get together. It is not just information within one setting. They give information from the IWK in Halifax to CHEO to the Hospital for Sick Children in Toronto. There is a pretty good network of giving the information.
I am then left with the question: What should we be doing? We are parliamentarians, legislators. Should patients who are getting a drug off-label be notified that it is off-label? Should we let things stay just as they are? It is working out relatively well.
I guess every drug has risks and benefits. One would hope that every patient would, in consultation with their health care practitioner, determine that the benefits outweigh the risks so that it is working for them.
I guess the short thing is what should we be doing as legislators and as the federal government? What should we be doing in terms of off-label usage? It is fairly prevalent, which is not a bad thing. However, in other ways that sort of scares me, namely that there is no scientific data; there is a lot of word of mouth. What should we be looking at or doing? Should we be changing anything?
Mr. Windross: Thank you, senator. I will attempt to answer your question from my perspective of being a pharmacist and having worked in teaching hospitals, in particular, earlier in my career at the Princess Margaret hospital as an example.
In reading the testimonies of past witnesses, I can certainly feel for some of the issues they are dealing with. I can also sense from their testimonies that yes this is how they are working today. However, treating a child with hypertension, for example, is not a large-scale situation in terms of numbers of patients, but to the pediatrician and to the family, that is an issue. What competence level do I have for prescribing this hypertension drug for a 14-year-old child? I am sensing in this world of information today, when there is so much coming at everyone so quickly, the ability to capture that and put it into some sort of repository that health care professionals would have access to. Perhaps that is being looked at by Health Canada and, again, resources come into play and how does it happen, et cetera.
However, from an industry perspective, we have all talked about what we can do. That is pretty straightforward and firm that in a commercial environment we can only go so far in what we are talking about. From the practitioner's perspective, there is this business of whether Health Canada, as an example, can provide more documentation, more resources, more ways of documenting something and making that available to practitioners.
I guess at some point I am also a bit torn because today, compared to 20 years ago, there is so much available. There are so many sites available and so much information available. There are companies that are in the business of computer technology and assimilating information. As soon as someone does some sort of mini-trial with about 10 patients and a particular indication, it is there; the information is there. We are now in a situation of how we facilitate the use of that information. That is a long answer to your question, senator, and I apologize.
Senator Cordy: It was a long question, too.
Mr. Windross: That is the way I see it from my background.
As an aside, if I compare the 1970s and working in oncology at Princess Margaret, which at that time and today is still a world authority in oncology, their biggest partner was MD Anderson in Texas. We did so many joint trials between MD Anderson and Princess Margaret because we did not have the population base or enough indications for use of some of these products in terms of treating certain types of cancer. The community got together and then developed their papers, published and all those different things they would do.
From my perspective, I see this being an issue to a certain extent, but it is how we manage the information we are gathering today so that people can get the information quickly and make a confident decision. In using this particular drug for a teenager at age 14 to treat high blood pressure, I can be relatively confident that it is okay even though it is an off-label use.
Mr. Robinson: I would pick up on two points. First, as I think you heard in testimony before this committee, an indication that may be approved in the United States may not be approved here or an indication that may be approved in Europe may not be approved here. We saw this in the context of drug shortages and changes that may happen through the Regulatory Cooperation Council. For example, some of the work that the government is doing is mutual recognition or mutual work on different indications in different jurisdictions to fast-track — without compromising safety or efficacy — indications that are approved in one country but not in another. This would get at the issue of having a new indication, an approved indication for something that may be a standard in clinical practice already.
In phase 1 of your work in this study, you have already talked about some of the solutions in the context of improving the overall environment for the conduct of clinical trials in Canada. I think some of that work could go to facilitate more clinical trials on new indications that are right now in off-label uses. There are a few examples of things that could be done.
The last point Mr. Casey raised was whether the Government of Canada could monitor or do something different. We need to fully understand the capacity of Health Canada today before recommending further things to do in a period of budget austerity to get the budget back to balance. You heard officials from Health Canada, for example, and there is policy suasion that the government has in the context that some people have talked at this committee about adverse events. We have an adverse event reporting system in this country — whether a medication is being used on label or off-label, for example — that can be taken greater avail of.
We have 560 million or so prescriptions written every year in Canada, and we should encourage patients to report and consult with their health care professional if they have an adverse event. The only people obliged to report adverse events in Canada, if or when we hear of them, are sitting before you at this table. We would like other people to report. That would be another way to understand if there are risks to safety: Use the tools that are available now. We are obliged to provide any information we hear regarding those adverse events. Again, we are forbidden to promote off- label uses or indications, but if we hear of any adverse events we are obliged to report them.
Senator Cordy: If we are looking at adverse events, how can we make it easier for the general public to report an adverse event? In many cases, if a medication is not working, not that it would be making you extremely ill but if it is not working, human nature being what it is, they will throw it in a drawer and not report it but just not use it. How do we have patients assume, I guess it would be a responsibility, to report adverse reactions or if something is not working, whether it is off-label — we are talking about off-label — but off-label, on-label, whatever?
Mr. Robinson: This will probably not go where you want it to go, but it is a reality for industry: Part of it is in recognizing the value of not only our products but our people and processes that we bring when provincial formularies or five federal drug plans reimburse our products, whether full reimbursement, limited use or special access. We are often offering patient-adherence programs, appropriate-use counselling to work in concert with other health care professionals and/or with provincial or federal governments reimbursing medications. That is a part of a value-added product offering that we want to bring.
You have come back to another point, which is that it is about individual patient responsibility, and all of us have the responsibility to encourage Canadians to follow their script to the letter and, if it does not work, get back to your health care professional and ask why it is not working. I know it sounds like a simple answer, but sometimes those solutions are the best starting points.
Senator Cordy: Could any of you give me an indication of what the frequency is of off-label use? We have heard different percentages from people who have been here who talked about drug plans, but that would not give you an indication of whether it is on-or off-label. Do we really know what the frequency of off-label usage is?
Mr. Casey: We would not know, because it is not reported back to us what those therapies are used for.
Mr. Robinson: There is another challenge here, and there is an issue here that could be resolved with electronic medical records and better technology, but this is also an issue of taking very private data and aggregating it to a certain level where you can draw some population health inferences. I would like to point out, for example, that if you are at the pharmacy and you are waiting for your prescription for hypertension medication, that is fine. If you are at the pharmacy and the pharmacist calls you out or there is a consult and you are waiting for your prescription for obsessive compulsive disorder, whether on- or off-label, you may not want that data to be shared. There are issues of privacy here as well.
The Chair: We have had testimony with regard to this issue, and this follows up your point exactly, Mr. Robinson, that you have to look at that deliberately. There have been studies that have attempted to get a sense, but they have been focused studies looking at the situation as a whole, and the reports seem to suggest somewhere in the order of 11 per cent of the prescribing, and we have had that as official testimony before us, with regard to the senator's question.
Senator Seth: Thank you to all of you for your vast knowledge of off-label and generic medication.
Mr. Windross, you have such vast knowledge and have been practising for 38 years at the Toronto General Hospital and all of that. If you say the generic medication has the same effect and efficacy and the brand drug also has the same efficacy and effect, and knowing that the two medications, the generic and the brand, have so much difference in price, what would you say is the difference? What is the difference between the generic and the brand medications?
Mr. Windross: In terms of the price, you mean?
Senator Seth: In terms of the medication. Why do we have a brand if it is the same thing? Why, when you prescribe to the patients and give it to them, why do they want brand and not generic if they can afford it?
Mr. Windross: As I indicated in my remarks, when we talk about the application for a notice of compliance or a licence to sell a generic product in Canada, we have to show the regulator, Health Canada, that our product has the same standard, the same quality of active ingredients.
The Chair: I will ask you to focus a quick answer. It is well known what the situation is here, and that is not the purpose of this study. Could you limit yourself, either you or Mr. Robinson, to the obvious legal requirements of Health Canada with regard to the issue of generic pharmaceuticals with regard to the active component and so on, but keep it short. I will not allow this to go any length.
Mr. Windross: I will have to have more clarification on the question, then.
The Chair: The question I will get you to answer, the essence of what she asked, is what the difference is between a generic compound and the patent medication, and I think she came about it from the point of view of price. I will not allow this to go much further. Just answer that directly.
Mr. Windross: The difference between the two products is there is a formulation difference: the active ingredient is identical, but some of the non-medicinal ingredients that may be in a tablet, capsule or suspension may be different. The non-medicinal ingredients are used from an approved list from Health Canada and the product must be shown to be equivalent to the brand product when administered to a patient.
Given the same blood levels of the active ingredient, the ingredient that treats the high blood pressure would be the same for the generic and the brand.
Senator Seth: With off-label medications, when we use it for a long period of time, just like the example of Ventolin inhaler, it was off-label for pediatric use; you were not supposed to use it. What happens to convert to the on-label use of the medication? What is the process that the off-label medication has to go through to become on label?
Mr. Windross: If a company was interested in getting another indication for use for its product, it would have to apply to Health Canada for that indication and provide supporting data for that particular clinical use, which would mean a clinical trial.
Senator Enverga: Thank you for your presentations. We have seen great progress with drug manufacturers; we have discovered how to treat a number of cases and we also understand that it is a billion-dollar industry.
Canada's Food and Drug Regulations currently allow for eight years of market exclusively for innovative drugs, that is, generic versions. Will it be an improvement to the patented version that has been on the market for eight years? An additional six months of market exclusivity for new drugs can be granted when the manufacturer conducts clinical trials with pediatric or geriatric populations.
Is there a difference in terms of financial incentive between extending patent life and extending market exclusivity?
Mr. Robinson: I believe you are speaking to the specific issue of data protection in the context of a 20-year patent term of a patented pharmaceutical; is that correct?
Senator Enverga: Yes.
Mr. Robinson: Could you come back to the specific question you have asked, the difference?
Senator Enverga: Is there a difference in terms of financial incentives between extending the patent life and extending market exclusivity? Can you see any difference there?
Mr. Robinson: Under the Patent Act, and I do not want to get into CETA here in terms of differing points of view, you deal with various contents of the patent term. Market exclusivity is measured backwards from the end of a patent life to when you receive a notice of compliance and are reimbursed and on market.
In Canada, for the most part, most innovative patented medicines usually enjoy only five to seven years of market exclusivity during which their products are being reimbursed in the marketplace up to the time when the patent ends. Data protection is the content of the actual 20-year patent term; market exclusivity is a separate concept in that respect.
Senator Enverga: In your experience do the drug manufacturers conduct pediatric or geriatric trials in order to benefit from the additional six months or so of market exclusivity?
Jared Rhines, Scientific and Regulatory Affairs, Rx&D: In our experience, clinical trials are developed in order to meet the needs of the most pressing patients. I think the six-month exclusivity with pediatric would lower some barriers to doing pediatric trials, which take a longer time. There are fewer patients and there is a longer time to enroll. I think a six-month period would help encourage investigation of these patients, but that is not a sole motivation for doing it.
Senator Enverga: Would you be prepared to be extended?
Mr. Robinson: We would come back to the findings in phase 1 of your report, where Russell Williams, our president, testified that we believe a harmonized, patent protection intellectual property environment here in Canada will drive further inward investments from the global pharmaceutical industry. The record shows that 75 per cent of our billion dollars that we continue to invest in Canada, despite challenging market policy uncertainty, IP uncertainty and reimbursement challenges, goes to clinical trials. That is money that we invest into the health system, which affects Canadians positively, we believe, in every region of the country.
Senator Enverga: Will this prohibition require the approval sought by the manufacturers, including labelling pertaining to the pediatric population?
Mr. Robinson: There are two separate questions there: the intellectual property components governed by the Patent Act, which are the subject of some debate right now in the context of the Canada-European Comprehensive Economic and Trade Agreement; and then issues under the Food and Drugs Act and the context of how you label and for what indications. There are two separate questions there and two separate processes. I think that would be the best way to answer that question.
Senator Enverga: Do you have any suggestion on how we can make this better for you, as manufacturers?
Mr. Robinson: For the innovative-based industry, we could get the federal government to act upon almost all of your recommendations in phase 1 of your study to make Canada a more attractive place to conduct clinical trials and improve the health outcomes of Canadians in the long run.
Senator Eaton: Mr. Casey, I am fascinated by biologics. As we get more and more into the realm of personalized medicine and tracking the genome, will you have to find new ways or new uses for biologics? Will you have to do more off-label prescribing?
Mr. Casey: First, thank you for your love of the biologics part because that is near and dear to our members. We do not prescribe. The question you are asking is one that would be asked of physicians in terms of how they will proceed in terms of dealing with their patients.
Will there be increased use of biologics going forward in the context of personalized medicine, as you indicated? Absolutely there will be because we are able to have tailor-made therapies for these individuals, recognizing their genome map.
Senator Eaton: That will be, in a sense, off-label, will it not?
Mr. Casey: No, the therapies go through the same sets of clinical trials. They have to go through the same approval process. They have their own distinct approval process that is identical to the other drugs.
Senator Eaton: Even if it is something geared specifically to something I have, how will it go through a regulatory process?
Mr. Casey: It is unlikely that a therapy will be developed just for you, but parts of the therapy will be tailored for your use. That will happen. It will be ultimately up to the physicians to figure out what part of the therapy will be applicable and useful to you, not our companies. We will develop the therapies, but the physicians will be the ones to do that.
Senator Eaton: When a physician uses a biologic off-label because he thinks it might work in my case, does he report back to you? How do you build case for changing the mandate of the drug or the range that the drug can be used for?
Mr. Casey: Again, I cannot respond for physicians as to how and why they are making their decisions.
Senator Eaton: Do they report back?
Mr. Casey: They do not report back to us, no.
Senator Eaton: How do you build a case that a certain biologic drug is doing wonders in another disease that you did not think about?
Mr. Casey: That is based on evidence derived from other jurisdictions, as Mr. Robinson indicated before. That is, where it has either gone through clinical trials or where there is evidence out that there that indicates it would be useful for a new indication. However, if it will be used for a new indication in Canada, it must go through the same regulatory process.
The Chair: I want to come back to the underlying question that has gone through several of the questions from my colleagues winding up with the last question. I will take a little time to give a bit of a preamble here, because the crux of all of this is information gathering and analysis.
We know that off-label use includes two principal areas. First, there are large parts of the population that were not included in the trial, such as children, pregnant women, the elderly, for example. You have already indicated that often drugs can be prescribed by the practitioner to these groups based on absolute need and the experience of using the drug in the population for which it is approved.
The second major section of off-label use is the experience that occurs. We had an example here of oncology, where there is a tremendous network among the practitioners who are often using things almost experimentally in that particular area. They are gathering information and find that a drug that has been approved for a specific use has an advantage off-label. In other words, in addition to the fact that there are large parts of the population, such as children, pregnant women and the elderly, who are not always included in a deliberate trial and for whom the drug, if it is used, is automatically used off-label, there is the new indication that a drug may have benefit that occurs through the experience out there in the real world. Very clearly then, in order to have the greatest benefit to the health of a population and, second, to the knowledge base, which feeds back to your researchers and your approach to investigating and identifying new entities for specific applications, the ability to collect that information in real-world experience and to analyze it is crucial.
It seems to me that Google can tell any one of us in this room what clothing brand we are likely to buy next — and, Mr. Robinson, when you are likely to make your next suit purchase — by taking and mining huge amounts of data for indications. You all represent an industry based on knowledge — that is, one in which you have huge amounts of data and technology programs to help you mine that to use it in marketing, as well as in basic research. Since we know that roughly 5 per cent, as an outside figure, and maybe as low as 1 per cent of drug reactions are actually formally reported in any way that is collected, in this day and age, and with the background that I have just given, there must be a mechanism that will allow us to do what Mr. Casey said in the beginning. That is, it goes to Health Canada and it is collected, but it is not being collected anywhere in the world in large volumes relative to the number of prescriptions that occur. Yet, that data would be enormously important today if even a third of it could be collected and analyzed reasonably. It is not a simple issue.
I am not pretending it is simple just to get the input and then put it out. This is a complex set of issues, but we are moving increasingly toward understanding that individuals are different, not just groups of subpopulations but individuals moving toward personalized medicine. You might not be able to give me the answer today. If you can give us the answer today, that will be wonderful, but I sense, from your responses to questions, that you do not have an absolute answer, though you might have parts of it. I will ask you the question: What models do you think exist now that could be a basis for us to make a recommendation that would be realistic with regard to the collection and mining of this critical data?
Mr. Casey: I will take a first stab at it; it might make it easier for me. As you were laying out your question, I think you were entirely correct; it is about the information flow. One of the other questions earlier on left me wondering whether or not there are other jurisdictions out there doing something right. We are not unique in this challenge. Other countries, as I said in my opening remarks, are facing the exact same challenge. We have to recognize that we have a very small population, and sometimes it is best to learn from others. I unfortunately do not have an answer for you, but maybe that is where we have to look a bit further afield and recognize that, as you say, this information is out there, that the same sets of challenges are occurring in other countries and that maybe there are some lessons to be learned from someone who is doing it right, to pick up on Senator Mercer's earlier question.
The Chair: I am not seeing you all jump at it. The reality is that there is not an existing example out there. That is why I am putting it to you this way. There are sub-examples. There are people with certain diseases who get together, on their own initiative, form groups on social media and put together tremendous amounts of information that become quite useful. There are examples of specific research teams, like the oncologists, who have a really good network. We have been told that they have a very good working network and share information back and forth. That does not automatically get into a larger Health Canada database and get collected and so on. I will not push you further on this now, but I will not leave you, Mr. Casey, with a cop out that we can go somewhere else and look.
You, as I indicated, are part of a huge knowledge-based industry that collects information of all kinds, analyzes it and uses it in your business plans as you move forward and in your research programs and so on. On this particular point, I want you to think seriously about it, and, if you can get back to us with even any examples of parts of the answer that might be expanded, it would be tremendously helpful. It is my opinion, at least, that this is the critical basis of moving forward, not only in terms of the health of Canadians in the world but also, in your industry, in terms of maximizing your opportunities to identify uses of the chemicals you have already developed.
Mr. Robinson: Mr. Chair, you had two points to your question. One was about the subpopulations. One of the things that would be very relevant, from a public policy point of view, is greater support and opportunity for private principal-investigator-led trials for some of those subpopulations. Some of that was talked about in phase 1 of the study that you conducted over a year ago now.
You were getting at the phenomena of big data, so to speak, and data mining. I can tell you where this has worked — and the backbone of it has been the electronic medical record: It is the Mayo Clinic. Since 2005, every patient who has entered any of the three Mayo Clinic campuses in Rochester, Minnesota; Phoenix, Arizona; or Jacksonville, Florida has had an electronic medical record. The Mayo Clinic now has over 7 million electronic medical records, which they have used in four ways: one, in the context of the physician team or physician-led team, whether it be primary, community, ambulatory or acute care that they have given to that patient; two, within the sharing of the network within the institutions and across the three campus to get the outcomes data, whether a patient was prescribed on- or off-label; three, in the context of sharing that information with a variety of professional societies — thoracic surgeons, cardiologists, oncologists; four, in the context of aggregating that data and providing it to bodies like the National Institutes of Health, in the United States, to get those outcomes data. I can also point you to the fact that in the 2009 Recovery Act in the United States and the 2009 equivalent recovery act in China, of all places, infrastructure and monies were devoted to national electronic medical records health records systems. One of the challenges we have in our country, one of the beauties of the federation, is that various provinces can provide various needs and meet the specific needs of their populations. As we see with the history of medicare, it starts in Saskatchewan and moves across the country. The challenge we have, though, is in having that backbone of infrastructure to get at some of that data at that aggregated base, at patient-level outcomes and post-marketing, real-world surveillance. I would, if the chair will indulge me, take issue in the context that I think there is a huge difference between data mining with Google to determine if I will buy a new suit and data mining thousands upon thousands, if not millions, of patient experiences. What needs to be put into that is the questions the doctor asked the patient in getting to the prescription or the questions that a renowned pharmacist asked the patient in getting to that prescription or working with the prescribing professional. Big data is great, and it is a place where a whole bunch of companies are moving in and changing our business model and working with governments, but, at the same time, there is the context in which the analytics and the questions have to be asked correctly.
The Chair: You are absolutely right. Your point is extremely well taken. I was using it, just as I hope you implied, in the context that they are looking at huge amounts of data and searching for particular indicators. It seems to me that it should not be too large a stretch to refine that in the direction of the area that you correctly pointed out. The complexity of a drug reaction in an individual is far different than matching a pair of shoes with a jacket. However, it is that sort of thing; it is matching. The complexity goes further in terms of what other prescriptions they are on, their age, their weight ratio, the pharmacological properties of the individual and so on. You are absolutely right. I was not trying to push you too far. You have made the point extremely well, and I absolutely understand that.
I am simply saying that there might be something in the approach that is taken. I think that your example of the Mayo Clinic is an excellent one. They are, in fact, developing attempts to do this kind of in-depth analysis and to see what algorithms can be used to match things correctly in terms of those functions.
I might come back to this, but I want to come to the second part because you represent industry. One of the things that we have heard is that, when an off-label indication is identified through real world experience, the medical practitioner and their patients observe that, with a drug prescribed for a specific label indication, the people taking it are showing other reactions. You gave two examples of observations. In fact, in the cancer area, it is not unusual to see something being used for a specific indication and then something else occurring.
One of the things that were presented to us in this regard, though, is that there has been no real incentive for a pharmaceutical company or the industry, whether it is a generic or not — the basic patent area — to deliberately trial some of those indicators or seek label rights for some of those off-label experiences. You gave examples where they do occur, but in the broader range of the situation, is there an approach, either through the research entities like CIHR or incentives to your industries collectively that could be an encouragement to pursue off-label experience to the point that it becomes a label availability?
Would any of you want to touch on that?
Mr. Rhines: My initial comment to that would be that often there are tremendous challenges in moving off-label indications to on-label indications. Clinical trials are very difficult. Oftentimes when there is enough experience, convincing physicians or patients to participate in placebo trials becomes a problem. There are a lot of challenges. I would not say that there is not incentive to do it; there are just tremendous hurdles and challenges.
I think a large part of this will be addressed with the clinical trial action plan, which the government is very involved with. This is an effort to dramatically improve the clinical research environment here in Canada. Currently, it is not the most favourable environment when it comes to global research. Often, clinical trials here are longer and more expensive to complete relative to other countries. Getting these trials done in Canadian patients in off-label indications poses tremendous challenges.
I would say as an overarching sentiment — I do not think you often get these three parties aligned on sentiment — that there is a commitment to resolve issues. We recognize that there is off-label use in Canada. We are committed to help get data as best we see fit, and we are happy to participate in that solution with other stakeholders who are equally engaged.
There is not an answer to say this is how you do it because there are multiple challenges to it, and incentives and finances are not the major drivers of those challenges.
The Chair: I am sensing you will leave it there.
I have one final question for you. This goes back to the first one. I will address this to Mr. Windross because you referred to your pharmacy background and experience.
The idea has been floated before us that there could be some deliberate follow-up with patients, and you already mentioned the Mayo Clinic area where they do some deliberate follow-up circumstances. However, let me put it this way: Let us suppose that the prescribing physician does electronic prescribing. There are drop-down menus to help minimize electronic error, and one of those areas is off-label. The prescribing physician knows he or she is prescribing off-label. That button is clicked, and since this is electronic there is no problem that this is a little piece of paper where the doctor's signature is two thirds of the page. Then it comes to the pharmacist, and it may well be that the prescribing physician can perhaps indicate a general age, weight and some other things. We will not go too far, but certain identifiers.
It then comes to the pharmacist. We have been told in other studies that the pharmacists have good data systems across their profession and are often aware quickly of spikes in particular prescriptions that are occurring, and so on. Is there a way, with the practitioner pharmacist, that a strong follow-up system with the patient could occur that would put at least some minimum data into Health Canada's hands with regard to what type of individual received the prescription, if they took their medication as prescribed and if they noticed anything in particular?
Mr. Windross: I think anything is possible today, given what is happening on the practice side for pharmacists as well as the electronic data processing side.
I do not see what you describe as being an unreasonable thing, provided it does not go over the boundaries of privacy where patient identification is included, and neither the prescriber nor the pharmacist is put at any problems with providing that information. If it could be as seamless as possible, a pharmacist would gladly participate in that. I am not speaking on behalf of any pharmacy association, but from being a pharmacist and my prior background prior in hospital. I think your example is an interesting one. I had a bit of déjà vu when you spoke to that.
When we talk about teaching hospitals, the common function in a hospital is the patient's chart. Regardless of who you are as a practitioner — a pharmacist, dietician, physiotherapist, radiologist, physician — you have access to that chart and immediately know everything that is going on, right down to nurse's notes. However, our system is such that as soon as you leave that place and go into the community, the family physician's hands are tied, the pharmacist's hands are tied, the home care worker's hands are tied. It is like you start all over again to build your base of information.
The wonderful thing about our electronic world, personal data devices and all these sorts of things is that I see this as something that could happen and would be useful.
However, as we talk about off-label use, we also must understand that depending on the prescriber and the age of the drug, sometimes we are in a situation where a drug is indicated for something and the prescriber actually — with a drop-down box like that — would say I do did not know that was off-label. I thought that was the use of the drug because the drug has been around so long and it is actually the side effect of the drug that they are prescribing. For example, a drug that is a good sedative and does not have as many side effects from the standpoint of the morning after, et cetera. That becomes a bit of a challenge. It would be an education for the prescriber to know that.
I think my industry certainly supports that. There is support of that in terms of doing that.
The Chair: Thank you.
Mr. Robinson: I come back to the previous point I raised, senator. I do not think you implied or inferred this, but the way it came out was there would be a check box and that one check box could then move to a database where we could see how much off-label use occurs. That would be one record. You could have 5,000, 10,000 or 100,000 but without the context of why the doctor made that decision — not a manufacturer but the doctor or pharmacist. You could do a lot of harm with that data because it is out of context. Again, that is the risk of big data on large patient populations. There are epidemiologists and population health people and biostatisticians who could speak more eloquently to it than I.
The Chair: You made a good point, Mr. Robinson, in that we heard from others that one of the advantages of the electronic capability would be that perhaps you can get some. I wanted to deal with the straightforward, but you are 100 per cent correct. If a model could be developed, some of those additional characteristics could possibly be worked out. I am not putting it forward as a panacea.
You have been tremendously helpful to us. I was getting quite a kick out of some of the issues that arose because with the group that is sitting here there would be very different approaches to those issues such as when Senator Seth asked the question about composition. I imagine we could have quite an interesting discussion today, but that is outside the context of this issue. I know that is a major point of debate among some of the various individuals here. There were a few other things that fell into those categories, and you have maintained your usual tremendously valuable professional approach to this issue with us today.
On behalf of the committee, I want to thank you very much for appearing here. I declare the meeting adjourned.
(The committee adjourned.)