Thank you, Ms. Wasylycia-Leis.
Under the 48-hour mandate, we will deal with it this coming Thursday.
Pursuant to Standing Order 108(2), I would like to welcome you to our second meeting of post-market surveillance of pharmaceutical products, prescription and non-prescription.
Committee members, we have with us today witnesses who will be taking part in today's panel on industry. They are representatives of Advancing Canadian Self-Care, Canada's Research-Based Pharmaceutical Companies, BIOTECanada, and the Canadian Generic Pharmaceutical Association.
I would like to remind witnesses that they have 10 minutes per organization, and I will reiterate that because we do keep the time quite succinctly. You have 10 minutes per organization to make your presentations. The committee will hear all presentations first before proceeding to questions from committee members. So I will acknowledge you one by one, and when your time is up, I will go on to the next presenter.
Let us begin with Dr. David Skinner, president of Advancing Canadian Self-Care, NDMAC.
Good morning, ladies and gentlemen of the committee. I thank you for this opportunity to appear before you today.
This is Robert White, a colleague of mine and our director of scientific and regulatory affairs.
I am David Skinner. l am president of NDMAC. Our association is dedicated to advancing Canadian self-care. From sunscreens to pain relievers, vitamins to herbals, and toothpastes to acne treatments, self-care health products are vital tools in the personal health management of virtually all Canadians.
Our industry supports the need for risk-based regulatory interventions with respect to safety, efficacy, and quality. We believe that all products with health claims of similar risk should attract the same regulatory requirements, not just for post-market monitoring, but also for pre-market authorization to sell. This means there should be differing regulatory standards for products with differing levels of risk. Sadly, Canadian regulations are confusing, inefficient, and often arbitrary in the way they differentiate between health products of similar risk.
Health products can be divided into two major categories. First there are drugs and devices with risk profiles that require the intervention of a health professional to ensure their safe and proper use. These include prescription drugs, vaccines, medical imaging tools, and controlled substances. The second category of health care products is for self-care, which have risk profiles that permit their safe use on the basis of label directions without requiring the intervention of a licensed professional. The regulation of this latter category is inconsistent, at best.
To illustrate the confusing nature of the current regulations and nomenclature, we need to look no further than the terms of reference for this study. The stated intent is to review the federal government's role in post-market surveillance of prescription and non-prescription drugs. While it is clear that the committee intends that prescription drugs be within the scope of this study, it is less clear regarding non-prescription drugs.
Does this mean the focus is on products such as vaccines, controlled substances, exempt narcotics, and other drugs such as digoxin, insulin, and nitroglycerin, all of which are non-prescription drugs that are regulated under part C of the food and drug regulations but not listed in the prescription drug schedule? Does the committee also wish to include other items that fall under the same set of regulations as prescription drugs, such as toothpastes and sunscreens? If the intent is to include such items as antacids, laxatives, and cold products, then the question arises as to whether natural health products are also included, and if so, why not health products in food form?
The dangers of casting a broad net can be illustrated by the gross error of omission with respect to the establishment of price controls for patented drugs. When these regulations were promulgated, there had never been a single word uttered by Parliament about the rules being applied to sunscreens, chewing gum, anti-dandruff shampoos, nor any other self-care health product for that matter. Yet the patented medicine regulations were, and continue to be, mute on a definition of the scope of these controls.
The consequence of this is that the common definition of drug as found in the Food and Drugs Act has been used, thereby capturing everything from toothpaste and gum to allergy medicines. It has been conclusively demonstrated that self-care products operate in a highly competitive, out-of-pocket consumer pricing environment that negates the need for government price controls. Although the intent of Parliament never was to capture these products, lack of clarity has created a two-tiered market and reduced consumer choice.
This kind of overregulation has encouraged non-compliance and added unnecessary costs to the government and consumers. Our sector needs clarity. We do not wish to repeat the errors of the past by having our members' products lumped into the same basket as new chemical entities.
NDMAC does believe that regulatory efficiency and clarity is one of the greatest tools to ensure public safety and competitiveness. We endorse the need for post-market monitoring of all products under the Food and Drugs Act that carry health claims. The level of complexity needs to be proportionate to the risk of products.
New chemical entities, by definition, have the least market experience and have the least well-characterized safety profile. So these products would most surely be prescription drugs; thus their requirements would be significantly higher than those requirements for self-care health products, such as natural products and non-prescription medicines, as well as cosmetics and foods making health claims.
The regulations for lower-risk products, such as those for self-care, should be consistent, regardless of the form the products take. For example, calcium carbonate, whether it's in a tablet, a syrup, a drink, or a snack bar, is still a biologically active substance being delivered to the body, regardless of the format chosen by the consumer. In fact, it is consumer choice and consumer preference that often determines how this product is placed on the market. If it's promoted for its health benefit, either as a calcium supplement or an antacid, it must be subject to the regulations that reach beyond its fitness for general consumption. From the marketer's standpoint, the business decision to enter the health products market brings with it certain regulatory obligations with respect to ensuring appropriate use and the prevention of health fraud. These obligations should not be something that can be sidestepped through the choice of product format.
As the safety profile of self-care health products must be well known, the adverse events profile is also well documented, which negates the need for extensive post-marketing monitoring and reporting that are required for higher-risk products such as new chemical entities. Manufacturers of self-care health products report all adverse reactions to Health Canada and, on an annual basis, prepare and maintain a summary report with a concise and critical analysis of all adverse reactions for every product on the Canadian market. NDMAC believes that such regulatory oversight is sufficient for self-care health products.
Currently, some self-care health products are captured by part C of the food and drug regulations, where they are regulated alongside higher-risk products such as prescription drugs and vaccines. Other self-care products are handled by part D of the regulations, the natural health product regulations, and still others by part B, the foods regulations.
NDMAC urges the committee to recommend that a simplified, consistent, and comprehensive system of regulation for self-care health products be created outside part C of the food and drug regulations. Within the self-care regulatory framework, post-market monitoring should be established based on well-known safety profiles of lower-risk products and the requirements be made proportionate to the risk.
Thank you for your attention, and I await your questions.
Thank you. My name is Pier-Giorgio Fontana and I am a consultant for Canada's Research-Based Pharmaceutical Companies.
I am very pleased to appear before this committee on behalf of Canada's Research-Based Pharmaceutical Companies, Rx&D, to discuss the very important issues of post-market surveillance of pharmaceuticals.
Rx&D, as you know, is the national organization representing more than 50 research-based pharmaceutical companies in Canada and the 20,000 men and women who work for them.
Averaging more than $1 billion a year in research and development investments, we are one of the country's most R and D-intensive industries, second only to the telecommunications sector.
Let me begin by stressing that drug safety is of the utmost importance for Rx&D member companies. Evaluation of a drug's safety starts in the laboratory, continues through clinical development, and is pursued with diligence as long as a medicine is on the market. This sustained effort helps ensure that the therapeutic benefits of new medicines outweigh any potential risks to patients.
Innovative pharmaceutical companies worldwide invest significant resources in safety departments whose experts, in collaboration with the stakeholders, epidemiologists, and other researchers, focus on post-market surveillance as well as assessing and reducing risk. This work continues throughout the entire life cycle of a drug. The safety experts in each company are part of a system under which manufacturers have an obligation to report adverse events received from any source to national and international health regulatory authorities. These experts follow up individual cases with the health professionals or others involved in the initial report to ensure the accuracy and completeness of the information. This information is subsequently analyzed by the regulatory authorities. Adverse event data is also entered in the manufacturers' global pharmacovigilance database and analyzed for periodic safety update reports, also referred to as PSURs, which are submitted to the regulatory agencies.
Following discussion with health authorities, we communicate to health care professionals in institutions important changes to the safety profile of the product. These changes are reflected in documents approved by the regulator. Occasionally, due to new safety information altering the benefit-risk balance, a product may be withdrawn from the market or its use restricted. Furthermore, pharmaceutical companies have been discussing and reaching agreements with major regulatory authorities, including Health Canada, on approaches to post-market safety planning for individual products before their approval.
In addition to informing regulatory authorities of all clinical trial results and ongoing studies as part of submissions to these authorities, the innovative pharmaceutical industry is also committed to increasing the transparency of clinical trials information to healthcare practitioners, patients and others.
In keeping with the work of our industry's global association, the IFPMA, our member companies are committed to posting results of all clinical trials, other than exploratory trials, once a drug has been approved in any country. Moreover, these confirmatory trials are posted at their onset in publicly accessible registries.
This information can be found online at the IFPMA clinical trials portal. This portal and the global industry's guiding joint position statements issued in 2005 can also be accessed through the Rx&D website.
We note that major jurisdictions abroad have developed or are developing clinical trials disclosure requirements. We recommend that the requirements being developed by Health Canada should be consistent with the approaches taken by the regulatory authorities in the United States and the European Union.
We believe that the current health safety system provides a significant level of protection while making available to patients the therapeutic benefits of innovative medicines. However, there is always room for improvement.
Rx&D feels strongly that the post-approval safety efforts in Canada could be maximized by taking an international perspective, harmonized with regulatory authorities like the U.S. and the European Union and consistent with best practices found in other jurisdictions. Health Canada may wish to pursue this more vigorously in order to create greater synergies with these key regulatory agencies. This would allow companies in Canada to better contribute to post-market safety by building more efficiently on the efforts of their global counterparts.
The use of common worldwide definitions and procedures, as well as compatible databases and analysis tools, would maximize the value of all available post-market data. Health Canada would then be in a better position to detect and evaluate potential adverse events as early as possible. In this context, it should be noted that Canada may not have the population size that would allow detection of very rare events.
Similarly, the discussions between the manufacturer and Health Canada on post-market safety planning for individual product should be based on harmonized guidelines and international databases. In this way, the global nature of the plans would increase the value of these post-market safety initiatives. Indeed, Canada has been contributing to the development of international safety standards and guidelines through participation in working groups involving regulatory authorities and industry experts.
Spontaneous reporting of adverse drug events is a valuable means of detecting potential safety signals in the post-approval context; however, it is critically important that the information reported is of sufficient quality to contribute to a scientifically sound decision. Therefore, we suggest that improved means of training and interacting with health care professions be developed to heighten awareness of the need for detailed and accurate reporting.
Detecting and assessing causes of adverse events requires robust methodologies, with the information then disseminated to all stakeholders. By keeping the manufacturer fully informed when evaluating safety signals, Health Canada would allow us to better follow the evolving benefit-risk balance of our products and communicate it in a prompt, accurate, and effective way.
The safety of new medicines can be improved through research aimed at strengthening drug development science already taking place in collaboration among industry, regulatory authorities, and academic centres in the U.S. and Europe.
As an active partner, the global innovative pharmaceutical industry is pursuing research to improve models and predictors for evaluating the safety and efficacy of drugs under development and reliable tests for detecting patients more at risk to certain adverse events.
In conclusion, Rx&D believes it has been a reliable contributor to the current regulatory system, and we are prepared to continue to work with Health Canada on ways to improve it.
We encourage the committee to take a global perspective to harmonizing our definitions, procedures, tools, and requirements with those major regulatory authorities abroad; report quality safety data from the field as a fundamental feature for the capture of adverse incidents in Canada; promote a collaborative approach between industry, regulatory authorities, and academia to create synergies needed to expand our collective knowledge on how medicinal therapies affect patients; and measure the impact on safety of any new initiatives.
I would like to thank the committee for this opportunity to talk about our role in post-market safety within a multi-stakeholder regulatory system that is designed to provide—and does provide—a significant level of protection to Canadians.
Let me reiterate that as an industry and a community we are prepared to work with Health Canada in the most efficient manner to maintain favourable risk-benefit balance for our products so that Canadian patients can derive the maximum therapeutic value from the medicine they take.
Thank you very much.
Good morning, Madam Chairman. Good morning, members of the committee. I am pleased to be here today and pleased you invited BIOTECanada to be part of this very important hearing on post-market safety for biologic products and vaccines.
The over 215 members of BIOTECanada are composed of innovative Canadian and world-leading multinational companies that are developing the next generation of life-saving therapeutics and vaccines for Canadian patients. My remarks today will outline some of the advances that biologic products have brought to the Canadian health system and the stringent processes currently followed by manufacturers to monitor safety and effectiveness of new therapies and vaccines, and I will suggest some steps Canada can take to improve post-market surveillance to reflect changing global priorities.
I'd like to start out by describing some of the advances that biologic products have brought to the Canadian health system. Each year, as part of National Biotechnology Week, BIOTECanada asks Canadians what they expect in terms of benefits from biotechnology. Consistently, over 80% of Canadians expect benefits to their health from advances in biotechnology, and today they are receiving those benefits.
The biological therapies and vaccines developed by BIOTECanada members have brought tremendous value to Canadian patients and the health care system. The therapies introduced over the past 20 years have improved the quality of life for patients suffering from crippling diseases such as rheumatoid arthritis, have resulted in better survival rates for cancer patients, and have provided a chance at life for sufferers of rare genetic disorders.
Likewise in the field of immunization, from the development of the polio vaccine to the recent introduction of immunization programs for human papilloma virus, Canada has led the world in the development of vaccines and public immunization programs. Today, Canadian companies are currently developing biotech treatments, such as the company Thallion Pharmaceuticals in Montreal, which is developing a new biological treatment for E. coli O157:H7. Companies like Amorfix in Toronto are developing innovative therapies for Alzheimer's disease, and companies like Biomira and BioMS in Edmonton are developing new vaccines against cancer and better treatments for multiple sclerosis.
While these innovative therapies and vaccines represent hope for Canadians who are suffering from or are threatened by these diseases, patient safety remains the primary concern and commitment of our member companies when they are developing these new products. This dedication is reflected in the actions companies take throughout the life cycle of a therapeutic product to meet, and in many cases exceed, the stringent safety requirements set in place by global regulatory authorities.
Our members comply strictly with Health Canada and global regulations for pre-clinical, clinical efficacy, safety testing, and manufacturing in the pre-market development of novel biological products.
Our members are committed to the registry and disclosure of results from clinical trials through the publicly accessible databases that Dr. Fontana has already mentioned. That is to ensure transparency in the clinical trial process.
Our members comply with global mandatory requirements for post-market pharmacovigilance and they voluntarily maintain global patient registries to continue to monitor safety and efficacy and to update regulatory authorities appropriately when safety issues arise.
Finally, our members are actively engaged in the consultations on the development of the progressive licensing framework.
But one cannot talk about the post-market safety of biological products without also considering the extensive and deliberate processes followed by manufacturers and regulators to assess the risks, benefits, and safety of a new therapy before it ever reaches the market.
A new biological therapeutic must pass multiple hurdles in manufacturing process development and pre-clinical and clinical trials before it ever receives market approval. These studies might take a decade to complete and cost hundreds of millions of dollars.
Add to that fact that over 80% of potential therapies that enter development fail to reach the marketplace and you can see the challenges faced by both innovative companies developing new biological treatments or vaccines and, most importantly, the patients who desperately need those therapies.
Our members work closely with Health Canada regulatory authorities during the pre-market phase of the product's evaluation. As I mentioned, our companies comply with Canadian and global requirements for clinical trial design, and we publish those clinical trial results on public websites.
When a new biological therapy or vaccine receives a market authorization in Canada, Canadians should have confidence that every known measure has been taken to ensure that the product is safe and effective and that the benefits of the new product outweigh any potential risks.
In the post-market area, the safe and effective use of a new therapy represents a complex series of overlapping responsibilities starting with manufacturers and Health Canada, but also involving health care professionals and patients. Doctors have a responsibility to prescribe medications to patients in accordance with the terms of the Health Canada licence and the corresponding product monograph, and patients have the responsibility to adhere to their treatment regimes.
Manufacturers and Health Canada have an important responsibility to collect adverse event data, to continue to monitor the safety profile of the products post-market, and to take appropriate remedial measures that are reflective of the risks and benefits associated with the continued use of the therapy.
Each of these players in the health care system needs to work collaboratively to continue to improve the post-market safety of these products, including improved communications between all parties regarding adverse events and safety concerns.
In addition to the post-market surveillance required by Health Canada, manufacturers also undertake voluntary activities to ensure the safety and effectiveness of these therapies, including, but not limited to, the creation of extensive patient registries, continued clinical trials, and implementation of risk management plans. These efforts provide valuable information to regulators, physicians, and patients throughout the life cycle of a therapeutic product.
As members of the committee examine this issue, it's important to recognize that efforts are under way in Canada and major jurisdictions right now to continue to strengthen post-market surveillance and safety. Our member companies are engaged with those efforts on the global level.
Both the EMEA in Europe and the U.S. Food and Drug Administration are adopting life-cycle approaches. Our members are pleased that Health Canada is also considering adopting a life-cycle approach to drug regulation. BIOTECanada members have been pleased to be part of the ongoing progressive licensing framework. This framework provides an opportunity for Canada to modernize its therapeutic regulatory system to reflect emerging global standards and emerging science. We are eager to receive more details on the specific legislative changes that are contemplated by the food and consumer safety action plan. We encourage the committee and Health Canada to look to our international counterparts when considering recommendations to enhance Canada's post-market safety.
As I mentioned, key to the success of the post-market initiatives under PLF is the development of stronger communication links between manufacturers and the marketed health products directorate at Health Canada. In many cases, Health Canada has access to adverse events reports from health care professionals, patients, or provincial public health agencies that have not been made available to manufacturers. Manufacturers may also have access to databases and patient registries that track the use and safety of the therapy around the world. Improving this communication will require additional resources at Health Canada.
When potential safety issues do arise in the post-market phase of a product's life cycle, these improved communications between Health Canada and manufacturers about potential risks must be balanced against the known benefits of the product in question. Similar risk-benefit assessments used in the pre-market assessment period should be adopted in the post-market period to put safety signals in context to ensure that a beneficial therapy for the vast majority of patients who use it is not removed from the market due to a very narrow set of safety concerns. Upon consideration of all available safety data, a more balanced and effective range of actions may be taken in considering the risk-benefit profile of the product.
In summary, I again thank the chair and the members of the committee for the opportunity to appear before you today, and I reiterate the commitment of BIOTECanada members to the continued development of safe, effective and innovative breakthrough therapies for some of the most devastating illnesses affecting Canadians.
We look forward to continuing to engage the members of this committee and Health Canada to advance our mutual goal of a healthy, productive Canadian population and a robust Canadian biotechnology industry.
Thank you. Merci.
Good morning, ladies and gentlemen, Madam Chair, and members of the committee.
My name is Colin D'Cunha, and I'm joined today by my colleague, Jacqueline Conant. On behalf of the Canadian Generic Pharmaceutical Association and its member companies, I would like to thank you for this opportunity to participate in the committee's study on post-market surveillance.
CGPA represents manufacturers and distributors of finished generic pharmaceutical products and active pharmaceutical chemicals. Generic drugs fill more than 47% of all prescriptions in Canada, even though they accounted for less than 20% of the approximately $18 billion that Canadians spent on prescription medicines last year. Almost all of the generic drugs sold in Canada are made right here in this country, and Canada's generic pharmaceutical industry employs more than 10,500 Canadians in highly skilled, well-paid jobs. It reinvests about 15% of its sales, that is, about $450 million each year, in research and development.
Addressing my comments to pharmacovigilance in Canada's generic pharmaceutical industry, the monitoring of the use and effect of medicines is an essential focus for any pharmaceutical company. Generic drugs are approved for sale by Health Canada and are identical or bioequivalent to the brand-name version. By the time a generic version is licensed for sale in Canada, the active substances are well documented and their safety profiles are generally well established.
Unexpected adverse events for these well-known substances are rare. Even so, Canada's generic pharmaceutical companies take our post-market surveillance efforts and responsibilities very seriously. All pharmaceutical companies in Canada are required to monitor the use and effect of a given medication and to detect, assess, understand, and prevent any adverse reactions or any other medicine-related problems that may arise. These activities and the science behind them are known as pharmacovigilance in the pharmaceutical industry.
Both Jacqueline and I are members of the CGPA's pharmacovigilance working group. This is a group of scientific experts from Canada's generic pharmaceutical companies who share information about global best practices in pharmacovigilance, changes in international reporting requirements, and various scientific developments.
Our goals in pharmacovigilance are to protect the public's health by monitoring the safety and efficacy of our products; to limit risk, which we achieve by iterative risk management throughout the product's life cycle and by conducting signal detection and safety review of the data available to us; to undertake effective risk management activities, including risk communication, core safety information, registries and post-approval studies where appropriate; and to place a strong focus on any product with an identified safety concern.
Canada's generic pharmaceutical industry operates in a global environment, with about 40% of the generic drugs manufactured in Canada being exported to the United States and to more than 110 countries worldwide. As one can imagine, these countries have a wide range of post-market surveillance requirements. As such, Canada's generic pharmaceutical industry is obligated to ensure our procedures are as robust as possible and comply with the most stringent of international pharmacovigilance regulations.
Generic pharmaceutical companies in Canada have standard operating procedures for the collection, assessment, and reporting of adverse drug reactions, both in clinical and post-marketing experience. These procedures are compliant with national and international regulations and guidelines. Our member companies prepare safety reports to meet regulatory obligations, including the seven-day and 15-day expedited reports for serious adverse drug reactions and the annual and three-year periodic safety reports. We also conduct ongoing monitoring and literature reviews on a global basis to identify any adverse reaction case reports. Our companies also develop customized safety evaluations for any products requiring post-approval risk management. Drugs in this category include isotretinoin, used for acne, and clozapine, used for schizophrenia.
Our risk management process is based either on regulatory guidelines from Health Canada or on established practices in Europe and the United States.
Coming, then, to recommendations, the generic pharmaceutical industry has identified some gaps in Canada's post-market surveillance system. We have made several recommendations to Health Canada. I know that some of these points were included in the presentation by Health Canada officials last week, and we are pleased to share our recommendations with you today.
Canada should align itself with the most stringent reporting requirements of the European Union and the United States, moving toward the use of electronic reporting and harmonization of birthdates for periodic reports. Health Canada should work with other agencies, such as the European Medicines Agency and the FDA in the United States, to undertake a single-source or one-source literature review. This would allow for a concise and highly informative report and avoid duplications in reporting.
Health Canada should provide safety information freely and without charge. Currently, Health Canada requires payment for this information, for adverse drug reactions reported directly to it. This may have the effect of potentially compromising public health, limiting the ability of manufacturers to perform risk benefit analysis and public communication.
Health Canada should take a leadership role in safety, working with all marketing authorization holders and conducting its own safety assessments, which is the current practice for the FDA.
Health Canada should also take a leadership role in coordinating the risk management activities of all relevant manufacturers and marketing authorization holders of a multi-source drug product when a safety concern is identified. This would ensure the best communication and management of the risk to public health.
Post-marketing risk management activities should be identical for both brand-name and generic products. This is the current practice, and it should continue. Generic products have the same risk management profiles as their brand-name equivalents and should not be subject to any additional requirements.
In conclusion, it is essential for all stakeholders, in particular the pharmaceutical ones, to play an active role in drug monitoring programs and to ensure that patients receive only safe and effective medicines.
Canada's generic pharmaceutical industry remains committed to good pharmacovigilance practice and to working collaboratively with both domestic and international health authorities and other stakeholders to minimize public risk and ensure the safe use of generic drugs.
Jacqueline and I both look forward to your questions this morning. Thank you. Merci beaucoup.
Yes. I'll start, if you like.
We invest a lot of resources in educating patients about the appropriate use of medication. As you know, when a product is approved, there is labelling that defines the parameters of use. We need to encourage patients to, first of all, follow the advice of the physician to look at the patient insert, a leaflet that is part of the product monograph and that is inserted with the medication.
We need to ensure that when a patient believes they are experiencing an adverse event, they communicate. Generally this is done with the pharmacist or the physician. Ultimately, though, Health Canada, either from the manufacturer or directly from the field, has access to all this information.
Patients sometimes believe that all drugs are 100% safe. As you know, this is not the case, and they have to be very cognizant about reporting any undue effect. Physicians and pharmacists have a role, when they dispense or prescribe a product, to play in that educational part, especially if it's a new approach.
Thank you for being with us today and trying to provide us with more insight on your various mandates and on how to interpret your initiatives.
These days, the average citizen feels that he or she may or may not be safe, given the horror stories we read in the paper about deaths, about products that are harmful to the health and about medications that ought not to be on the market. The impression is that we do not have all the information that we would like about the seriousness of the post-market process and about clinical trials.
Mr. Fontana, you say that public posting of information on clinical trials is intended to increase the transparency of the information posted. I understand your objectives. You continue by saying that the International Federation of Pharmaceutical Manufacturers and Associations has to post the results of all clinical trials and that these should be publicly accessible.
But we are not aware of the adverse events. The public has no access to those. That information seems somehow to be shrouded in mystery.
Research protocols are not published. At very least, these protocols are important in assessing the validity of the trials. Do you not think that they should be submitted to an independent body? This point has often been raised by some observers of the pharmaceutical industry.
Could there be a publication on research that leads to adverse events and on all research protocols?
: Merci pour votre question.
The clinical database is now available through international websites and registries.
We in Canada are in agreement with the recommendation of the International Federation of Pharmaceutical Manufacturers and Associations in publishing in these registries all the clinical trials that are conducted. This is also inclusive of studies that are not started, so that from the outset the protocol or the description of that study is also publicly available.
The fact that some of the studies might not appear in the literature does not mean they escape regulatory scrutiny, because all clinical trials, including the ones that are under way, are part of the new drug submission. So there is scrutiny of all clinical trials, and post-marketing as well—phase 4 trials—will be part of this database.
There can be access, as I mentioned, through portals such as the portal of the IFPMA, and also by Rx&D, but there are other international databases, such as that of NIH or those of the other international organizations. So there is that level of access and transparency.
From the variety of evidence that we have heard this morning, one gets the impression...You know that pharmaceutical companies must give reasonable information about follow-up both on the trials process and on post-market safety. But healthcare professionals are the ones who have to provide the most information to Health Canada, and they do it voluntarily.
Why is the pharmaceutical industry not proactive? How is it that healthcare professionals have to do it? I will not list all the products that have been re-examined from an ethical standpoint and, at very least, whose negative effects and dangers should be made known. In some cases, even deaths have occurred.
BIOTECanada also comes to mind, and GARDASIL, the human papilloma virus vaccine. It is administered very widely in Canada now, even though we know that there have been five deaths in Europe. You are aware of this, of course. You said you are very proactive in providing information and making sure that products do no harm.
What does a company like BIOTECanada do? I asked Health Canada what its responsibility is and I was told that responsibility lies with the Public Health Agency. The vaccine comes from a company like your own. Now we are told that the Public Health Agency is responsible for it. I was not talking to the right person. I was under the impression that it was Health Canada, because that is the department that you have to report to. Things seem to be at an impasse.
I would like you to answer my questions.
Thank you, Madam Chairperson, and thanks to all of you for your input today. Clearly there are some very divergent views on the question we're tackling as members of the health committee.
It seems to me that when we're talking about post-market surveillance, we're really trying to get from you the best advice for how government, i.e., Health Canada, can ensure that the drugs you put on the market are safe beyond a reasonable doubt and that there are checks and balances in place by government, not by those with vested interests to do that.
I'm very concerned, Dr. Fontana, that you're suggesting, in fact, more collaboration between government and the drug industry on this front, and you have made no recommendations for how you think you need to have proper oversight to ensure that Canadians' health and safety is put ahead of your right to make profits, and that's why you're in the business.
I'm very concerned that you seem to be going along with this risk management model of Health Canada, which of course will aid and abet your bottom line but will do nothing to help Canadians. Why are you not supporting the idea of an independent board to evaluate drug safety, as I understand the representatives from the Generic Pharmaceutical Association are? I'd like to hear from both of you about your views in terms of government's role vis-à-vis safety of drugs and who is in the best position to do that.
Thank you all for appearing and informing the committee.
I understand that with 10% being reported, the other 90% would be an estimate, because of the fact that people aren't required to report, either pharmacists or MDs.
I'm also a little concerned about the definition--if you're looking at serious adverse effects as opposed to adverse effects. You could have adverse effects that, if repeated over time, can become quite serious for the individual patient. At one moment, it might not require hospitalization, but it could weaken the patient and he could require hospitalization or suffer serious health effects because of other matters.
That could happen because of the improper use of a drug or the mixed use of different drugs, including self-help drugs.
I just want you to consider those things and how we capture that. I know it's not easy because we're always caught in the dilemma--where I'm sure everybody is caught--which is to make drugs available. If I have the illness, and especially if it's critical, then I'll try anything. If I'm going to die otherwise, I'll try anything. I'd like to have the drug available.
I applaud the use of off-label, but I worry that because the use of off-label isn't regulated too well, the critical events or the adverse events aren't being reported. There is no real way to report them or to share it with other professionals in the industry who may be using them off-label.
But I want to come back to the current definition. If you require hospitalization, is the hospital required to report it to Health Canada or the manufacturer at the current time?
Yes. The reporting can also be done electronically, and again, I think we have to encourage patients to report any event.
We, the manufacturer, through the source, have to report both serious and non-serious adverse events, especially the ones that are called “unexpected”, which are not in the labelling.
But I believe that at the present time the system is more efficient. I think we've also seen an improvement in the quality of reporting, as per some audits that were conducted by Health Canada over the last four or five years. So there is a certain level of compliance overall.
Underreporting is not only a Canadian problem; it's a problem in the United States, and even the FDA is wrestling with that aspect of reporting.
However, I must say that numbers are not really the only important aspect; it's the quality of these reports. As I mentioned, to make a scientific assessment of the relationship between the drug and the effect, you have to have quality data.
Your colleague mentioned earlier that some people may be reluctant to communicate this information because they do not want to lose their privacy. However, quality reporting doesn't involve the identification of the patient. You can just put initials. But you certainly need the age, you need to know the background, the terms of co-morbidity, you need to know the--
Regarding your earlier question about the impact of the progressive licensing framework, one of the core messages we'd like to deliver is that we don't want to lump all products together in one framework. The progressive licensing framework, if you look at the life cycle that they've described, starts with pre-clinical trial, clinical trial, new drug submission, new chemical entity, and all that.
When it comes to self-care products, none of that applies. They've been on the market for 20, 50, sometimes 100 years. They've been through all of that. If a product has been switched from prescription to non-prescription status, they've already had 20 years of experience with all of that.
So to have the same kinds of requirements that are anticipated for new chemical entities apply to everything under part C of the regulations would be a tremendous cost barrier to things like anti-dandruff shampoos, sunscreens, and other things that you can use every day for yourself. So that's a big thing.
With respect to the authority to recall, yes, I believe they should have the authority to recall. Health Canada has the ability to cancel your licence to market, so it's a very sharp tool with a big consequence. They can't say they want you to recall a product and keep it off the market while its under study. All they can do is say your product can no longer be marketed.
So they can take a product off, but it may be killing a mouse with a shotgun.
The length of a study varies depending on the disease. I think there are obviously international standards with respect to the length of a study. To demonstrate the efficacy of a product you don't necessarily have to test the product for a year. However, certainly for safety, studies are required to be longer.
There is a sense now that standards have been lower in recent years, but I do not agree, personally, with that view. As a matter of fact, if you look at the number of studies in the average new drug submission in the last 10 years, it has doubled. The number of studies that are required for a new drug submission has doubled. The number of patients has doubled.
I do not believe we are lowering the standards. I do not believe the time to review a drug is necessarily correlated with the outcome of that review. In other words, you could have an excellent review done in six months and a terrible review done in three years. So we have to be very careful about associating this concept of time with the quality of the data, the quality of the review.
The other thing I would add is that in Canada we see drugs actually available on the market significantly later than in some other jurisdictions, so there is time as well to observe the experience on the market.
I believe we have a system here in Canada, in some cases, where the international standard actually might not be followed. Health Canada was an observer of the International Conference on Harmonization. They endorse the standards that they feel are adequate, but the don't necessarily endorse others.
I hope this will address your question.
Thank you, Madam Chairperson.
Well, as usual, my good friend Steven Fletcher has distorted and taken out of context my remarks. Let me try to get back to what I think is the issue of the day, which is recognizing that drug companies, both brand name and generic, have a responsibility for their products.
It's also recognized that you can't have the fox in charge of the henhouse, so our job today is to try to find a way to make sure that there is good oversight from the government of those companies producing the products in which you obviously have an interest in terms of your profit margins.
My question is, given an issue such as the one involving Vioxx, where drugs on the market doubled the risk of heart attacks and stroke and three million prescriptions a year were being written when it was taken off the market, have we learned anything from it? And what changes do you think government should put in place to protect Canadians from that kind of situation?
Does anybody want to answer that?
It's in the briefing notes.
We will do that then and submit those questions.
There was a consensus, Mr. Fletcher.
An hon. member: It's tied, Madam Chair.
The Chair: It is tied. Let's try it again.
Who would like the questions sent to the clerk? Raise your hand.
There are five.
Who is against doing that?
There are two.
Well, we haven't got a consensus. Having said that, I would excuse the presenters.
Excuse me, presenters, could I ask you to do something for me, please, as chair? If you could, and with our thanks for your presentation, I would like you to quickly exit outside the door, and if anyone wants to speak with you, they can speak with you outside the door. We have two pieces of business, and I do have another committee that needs to be in right away.
I sincerely thank you for your presentation today. It was very insightful.
If I could get the committee together as our presenters are making their way out, I would like to ask two things of the committee.
We will be asked to adopt a budget at next Thursday's meeting. This is to cover the expenses of witnesses, who will be travelling to Ottawa, as well as to cover part of our study on post-market surveillance.
We also have another issue. There has been a request for some fruit and cookies to be brought in because we have a meeting between eleven and one. The cost is not very much; it's around $50 a meeting. The sandwiches are very expensive, but cookies and fruit will tide us over and are not too much. Can we agree that it is okay to bring those in?
Some hon. members: Agreed.
The Chair: Yes, it is agreed. Thank you. We will do that.
I would also like to remind members to please send in their suggestions for witnesses for future meetings on toy regulations. That meeting is on April 1. We need witnesses and we don't have them. We also need witnesses on natural health products. That meeting is on April 15. The clerk emailed your offices last Wednesday concerning this matter. We're bringing this up because the witnesses have not come forward.