Health Committee on Feb. 5th, 2008

[The Chair, Conservative, Joy Smith]

Welcome, everyone, to our committee today. I'm so pleased that we could have a chance to welcome our witnesses today and thank them for coming. Here in the health committee we have looked very much forward to all the people who have come and presented to this committee, so, as I said, welcome.

Ms. Wasylycia-Leis.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

I have a point of order, please, Madam Chairperson.

I would like to take a moment to present a motion and give notice as of today, so that it can be considered sometime after the 48-hour period. I have copies in two languages.

I move that the Standing Committee on Health call on the government to strengthen its monitoring and analytical capacity regarding enforcement of the Canada Health Act in order to better identify challenges facing public health care, including excessive wait times for diagnostics and treatment, the high cost of prescription drugs to individuals in the health care system, and the impacts of increased privatization; and that the Minister of Health appear before the health committee within 30 days following the publication of his department's Canada Health Act annual report to indicate what proactive measures his government will be undertaking to ensure that Canadians' rights under the act are fully protected and strongly enforced in light of the current challenges to Canadians' public health care system.

[The Chair, Conservative, Joy Smith]

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.

[David Skinner, President, NDMAC]

Thank you very much.

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.

[The Chair, Conservative, Joy Smith]

Thank you very much.

We will now go on to Dr. Fontana, a consultant with Rx&D.

[Dr. Pier-Giorgio Fontana, Consultant, Regulatory Affairs, Canada's Research-Based Pharmaceutical Companies (Rx&D)]

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.

[The Chair, Conservative, Joy Smith]

Thank you, Mr. Fontana.

We will now continue with the presentation of Dr. Philip Schwab, the vice-president of industry relations at BIOTECanada.

[Dr. Philip Schwab, Vice-President of Industry Relations, BIOTECanada]

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.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Schwab.

We're now going to hear from representatives of the Canadian Generic Pharmaceutical Association, and Dr. D'Cunha.

[Dr. Colin D'Cunha, Director, Pharmacovigilance, Apotex Inc., Canadian Generic Pharmaceutical Association]

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.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. D'Cunha. I thank all the people who came in to give presentations today. They were very insightful.

We'll now proceed with the questions. The first round will be seven minutes per member.

We will begin with Mr. Temelkovski, please.

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

Thank you very much, Madam Chair.

Thank you to all the presenters.

Dr. Fontana, you mentioned in your conclusion that you encourage the reporting of quality safety data from the field, as a fundamental feature for the capture of adverse events. What do you mean by “encourage”? Should it be left to the professionals to decide on that, or should it be mandated, but by their professional associations? What do you have in mind?

[Dr. Pier-Giorgio Fontana]

We stress the importance of quality reporting, which is done in the field spontaneously by health care professionals. We also encourage them to use the CIOMS V form, which is an internationally accepted standard for reporting. We believe the use of that form, by the very nature of the structure of that template, is going to help them provide the type of information the companies will require in order to make an assessment of the risk of the association between the noted adverse event vis-à-vis the drug.

The fact that an adverse event is reported per se is not as important as all the information that is required to assess the relationship of the causality between the drug and the adverse event.

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

Dr. Fontana, is this format reported to the manufacturers, and is it also reported to Health Canada?

[Dr. Pier-Giorgio Fontana]

Generally, the way the system works, of course, is that the health care professional has the liberty of filing to both Health Canada and the manufacturer or to either. The regulations for the manufacturer are that whatever we receive, and also whatever we scan in the literature—any source of information with respect to adverse events—should be reported within the specified timelines in the regulations.

Again, the dialogue can be also directly between the health care professional and health care. As has been alluded to by one of my colleagues—I think it was Mr. Schwab—this is an area where we need to be very careful in terms of duplication of information. Obviously, duplication of information can introduce a bias, so we need to be very careful about how this is done.

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

I understand, from all of the presentations we've heard, that there's a lot of dialogue and communication between Health Canada and the manufacturers, whether they're brand name or generic. So there's a lot of communication between the two organizations, but I fail to see the connection between the communication between the joe on the sidewalk who has had an adverse reaction and Health Canada or the manufacturers. As far as I know from speaking with pharmacists, they're not sharing much information with too many people. They're not sharing it with the pharmacist down the street. They're not sharing it with the hospital down the street. They're not sharing it with too many people.

So we're looking at communication not between the manufacturers and Health Canada but between the end user and Health Canada.

Can you help us with that? Do you see the deficiencies that we see, or do you not see a deficiency there?

[Dr. Pier-Giorgio Fontana]

I think we all—

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

This is to everyone.

[Dr. Pier-Giorgio Fontana]

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.

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

Do they have a role, in your view, to report it?

[Dr. Pier-Giorgio Fontana]

Absolutely.

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

We understand they have a role to educate the consumer in front of them. If the consumer starts reading the information that is inserted, it doesn't make much sense to them unless they're in the science field. I mean, you can just imagine what it looks like to most people.

Do they have an obligation to report that, or, as I have heard, due to privacy laws they cannot report it here or there? Why wouldn't they report it to Health Canada as opposed to the manufacturer?

Dr. Skinner.

[David Skinner]

I think there are two things here. One was earlier said by Dr. Fontana, that nomenclature is very important in terms of trying to understand what we mean by adverse events. Most certainly the serious unexpected adverse events, which are the most important ones that are reported, the quickest and the most detailed, are the ones that don't actually happen as somebody is walking down the street and experiencing some other anticipated adverse event, which is sometimes known as a side effect. But when they are unanticipated and serious, those things do get reported.

The problem then becomes one of educating the patient and the consumer about what to expect from their drug therapy. As you begin to raise their expectations about some of the negative consequences that go along with the benefits, those things tend to not get reported because they're already well characterized and they're expected. So you're not getting that feedback loop as often as possible.

So having good nomenclature around adverse event versus side effect is important to make sure that the robustness of the database is really something you can base decisions on.

The second part is how do we get people to do something that they've not had to do before? How do we get physicians, province by province, to start to report more regularly these kinds of events? As I mentioned, my good old uncle, B.F. Skinner, said that the behaviour that gets rewarded gets done. And I think that's part of the problem. Is it a responsibility? Most certainly it is. Is it part of common everyday practice? No, it's not. It becomes part of common everyday practice when there is a mutual benefit to everybody participating in it.

So I think a lot of the behavioural aspects of doing good reporting relate a lot to some of the rewards that are available--

[Lui Temelkovski, Liberal, Oak Ridges—Markham, ON]

How much would these rewards cost?

[The Chair, Conservative, Joy Smith]

Mr. Temelkovski, I have to go on to Madame Gagnon.

Thank you, Mr. Skinner.

Madame.