HEAL Committee Meeting

37th PARLIAMENT, 2nd SESSION

Standing Committee on Health

EVIDENCE

CONTENTS

Thursday, September 18, 2003

¿

0910

The Chair (Ms. Bonnie Brown (Oakville, Lib.))

Ms. Diane Gorman (Assistant Deputy Minister, Health Products and Food Branch, Department of Health)

¿

0915

The Chair

Dr. Christopher Turner (Director General, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health)

¿

0920

¿

0925

The Chair

Dr. Christopher Turner

¿

0930

¿

0935

The Chair

Ms. Beth Pieterson (Director General, Drug Strategy and Controlled Substances Programme, Healthy Environments and Consumer Safety Branch, Department of Health)

¿

0940

¿

0945

The Chair

Mr. Gilbert Barrette (Témiscamingue, Lib.)

The Chair

Mr. Rob Merrifield (Yellowhead, Canadian Alliance)

Ms. Beth Pieterson

Mr. Rob Merrifield

Ms. Beth Pieterson

¿

0950

Mr. Rob Merrifield

Dr. Christopher Turner

Mr. Rob Merrifield

Dr. Christopher Turner

Mr. Rob Merrifield

Ms. Diane Gorman

¿

0955

The Chair

Mrs. Betty Hinton (Kamloops, Thompson and Highland Valleys, Canadian Alliance)

Ms. Carole Bouchard (Director, Office of Controlled Substances, Drug Strategy and Controlled Substances Programme, Healthy Environments and Consumer Safety Branch, Department of Health)

Mrs. Betty Hinton

Ms. Carole Bouchard

Ms. Beth Pieterson

The Chair

Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ)

À

1000

Dr. Christopher Turner

Mr. Réal Ménard

Dr. Christopher Turner

Mr. Réal Ménard

Ms. Diane Gorman

The Chair

À

1005

Ms. Carolyn Bennett (St. Paul's, Lib.)

Ms. Beth Pieterson

Ms. Carole Bouchard

Ms. Carolyn Bennett

Dr. Christopher Turner

Ms. Carolyn Bennett

Dr. Christopher Turner

Ms. Carolyn Bennett

Dr. Christopher Turner

Ms. Carolyn Bennett

Dr. Christopher Turner

Ms. Carolyn Bennett

Dr. Christopher Turner

Ms. Carolyn Bennett

Dr. Christopher Turner

À

1010

Ms. Carolyn Bennett

Dr. Christopher Turner

Ms. Carolyn Bennett

Dr. Christopher Turner

Ms. Carolyn Bennett

Dr. Christopher Turner

Ms. Carolyn Bennett

Dr. Christopher Turner

Ms. Carolyn Bennett

Dr. Christopher Turner

Ms. Carolyn Bennett

The Chair

Ms. Carolyn Bennett

Ms. Beth Pieterson

The Chair

Mr. Svend Robinson (Burnaby—Douglas, NDP)

The Chair

Mr. Svend Robinson

The Chair

Mr. Svend Robinson

Dr. Christopher Turner

Mr. Svend Robinson

Dr. Christopher Turner

Mr. Svend Robinson

Dr. Christopher Turner

Mr. Svend Robinson

Dr. Christopher Turner

Mr. Svend Robinson

À

1015

Dr. Christopher Turner

Mr. Svend Robinson

Dr. Christopher Turner

Mr. Svend Robinson

Dr. Christopher Turner

Mr. Svend Robinson

Ms. Diane Gorman

Mr. Svend Robinson

Ms. Diane Gorman

Mr. Svend Robinson

Ms. Diane Gorman

Mr. Svend Robinson

Ms. Beth Pieterson

Mr. Svend Robinson

Ms. Beth Pieterson

À

1020

Mr. Svend Robinson

Ms. Beth Pieterson

Mr. Svend Robinson

Ms. Beth Pieterson

Mr. Svend Robinson

The Chair

Mr. Stan Dromisky (Thunder Bay—Atikokan, Lib.)

Ms. Diane Gorman

Mr. Stan Dromisky

Ms. Diane Gorman

Dr. Christopher Turner

À

1025

Ms. Diane Gorman

Dr. Christopher Turner

Ms. Diane Gorman

Mr. Stan Dromisky

Dr. Christopher Turner

Mr. Stan Dromisky

Dr. Christopher Turner

Mr. Stan Dromisky

Ms. Diane Gorman

Mr. Stan Dromisky

Ms. Diane Gorman

Mr. Stan Dromisky

Ms. Diane Gorman

Mr. Stan Dromisky

Ms. Diane Gorman

The Chair

À

1030

Ms. Carolyn Bennett

The Chair

Ms. Diane Gorman

The Chair

Mr. Svend Robinson

The Chair

Mr. Réal Ménard

The Chair

Mr. Svend Robinson

Mr. Stan Dromisky

The Chair

Ms. Diane Gorman

The Chair

Mr. Rob Merrifield

The Chair

Mrs. Betty Hinton

The Chair

À

1035

Mr. Svend Robinson

The Chair

Mr. Svend Robinson

The Chair

Mr. Svend Robinson

The Chair

Mr. Svend Robinson

The Chair

Mr. Svend Robinson

The Chair

---

CANADA

Standing Committee on Health

---

NUMBER 044

l

2nd SESSION

l

37th PARLIAMENT

---

EVIDENCE

Thursday, September 18, 2003

[Recorded by Electronic Apparatus]

¿  (0910)  

[English]

    The Chair (Ms. Bonnie Brown (Oakville, Lib.)): It's my pleasure to call this meeting to order.

    This is the second meeting on our study on prescription drugs. This morning we have witnesses from the Department of Health. Ms. Gorman is the assistant deputy minister, Health Products and Food Branch. Dr. Turner is the director general of the Marketed Health Products Directorate. Ms. Pieterson is the director general of the Drug Strategy and Controlled Substances Programme. Not presenting but here to answer questions is Ms. Bouchard, director, Office of Controlled Substances, Drug Strategy and Controlled Substances Programme.

    We'll begin right away with your presentations. We'll start with Ms. Gorman.

    Ms. Diane Gorman (Assistant Deputy Minister, Health Products and Food Branch, Department of Health): Thank you, Madam Chair and members of the committee.

[Translation]

    Thank you for the opportunity to address the committee this morning. I will be focussing my remarks mainly on four areas: the drug review process carried out by Health Canada, HPFB's mandate with respect to drug access, post-market assessment and surveillance activities and regulation of drug advertising in Canada.

[English]

    First I would like to set some context in terms of the role of the Government of Canada, and specifically Health Canada. The Government of Canada has a number of responsibilities pertaining to the ability of Canadians to access safe human drugs and other therapeutic products. In this regard, Health Canada regulates the safety, efficacy, and quality of therapeutic products under the Food and Drugs Act; administers the Patented Medicines (Notice of Compliance) Regulations; and assists with the responsible management of pharmaceuticals through collaborative efforts with provincial partners.

    The Patented Medicine Prices Review Board, the PMPRB, regulates prices of patented medicines. I understand your committee will be hearing from the PMPRB next week on September 23.

    To support Health Canada improvements and business transformation activities in the area of therapeutic product regulation and access, the Government of Canada recently made some significant commitments.

    First, the 2002 Speech from the Throne committed to “speed up the regulatory process for drug approvals to ensure that Canadians have faster access to the safe drugs they need, creating a better climate for research in pharmaceuticals”. This is found in the Speech from the Throne under the section described as “Smart Regulation” strategy.

    Also, the 2003 First Ministers' Accord on Health Care Renewal commits federal, provincial, and territorial governments to further collaborate to promote optimal drug use and best practices in drug prescription, and to better manage the costs of all drugs, including generic drugs, to ensure that drugs are safe, effective, and accessible in a timely and cost-effective fashion.

    Finally, the commitment in budget 2003 provided “$190 million over five years to improve the timeliness of Health Canada's regulatory processes with respect to human drugs, in order to create a better climate for research in pharmaceuticals while preserving the principle that safety is of paramount concern”.

    In response to these commitments, Health Canada has developed the therapeutics access strategy. This is a joint initiative between two branches in Health Canada, the Health Products and Food Branch and the Health Policy and Communications Branch. It aims to improve timeliness and transparency of the review process for therapeutic products, while maintaining a high standard for safety, exercising greater vigilance around safety and therapeutic effectiveness issues once those products reach the market, and improving access to the appropriate and cost-effective drug therapies that Canadians are demanding.

    To achieve these objectives, the therapeutic access strategy will ultimately address the full range of influences on access to therapeutic products, including research and innovation, clinical trials, and other steps that lead to market authorization, inspection and compliance post-market, post-market safety and therapeutic effectiveness, appropriate utilization in prescribing practices, price, cost-effectiveness, and drug management plan.

    We are also investigating enhancing international regulatory collaboration and increased transparency. We work closely with international partners through the International Conference on Harmonization--I believe Dr. Peterson spoke to you briefly on that the other day--ensuring that data standards that support electronic submission and simultaneous filing of submissions in multiple jurisdictions will be developed so that Canada can benefit from them.

    As you will have heard on Tuesday in some detail from Dr. Peterson, the Health Products and Food Branch has a regulatory responsibility to review the safety, quality, and effectiveness of all therapeutic products before they are available for sale to the Canadian public. In Canada today there are more than 24,000 marketed therapeutic health products and over 50,000 medical devices.

    Dr. Chris Turner, who is with me this morning, is the director generalof marketed health products. At the conclusion of my remarks he will provide you with more detailed information about our regulatory responsibilities for post-market assessment and surveillance and our responsibilities with regard to drug advertising in Canada. But before I pass to Dr. Turner, I'd like to make a few general remarks about these two areas.

¿  (0915)  

    Post-market surveillance of a product's use outside the controlled environment of a pre-market clinical trial enables a greater understanding of the product's safety and therapeutic effectiveness. Post-market surveillance involves a complex set of activities with the objective of identifying or further clarifying risks and therapeutic effectiveness of the products once they are in the Canadian marketplace.

    Post-market surveillance activities are a shared responsibility of manufacturers, health professionals, researchers, and regulators. Considerable consultation and collaboration among these various stakeholders, including consumers and patients, health professionals, researchers, industry, and domestic regulators, are necessary in order to accomplish successful post-market surveillance. Dr. Turner will talk to you about some of the international collaboration we are engaged in.

    In order to help augment information, given the fact that the Canadian population is a relatively small population, it's important that we have a broader demographic base in order to identify very rare adverse effects as well as to harmonize our activities with those of other countries.

    In short, the regulatory responsibilities we discharge with respect to strong post-market surveillance are essential to ensuring the safety, efficacy, and quality of therapeutic products in Canada over the long term, and we ensure Canadians derive optimal benefits from these products.

    In my final comments I will introduce our regulatory responsibility for drug advertising in Canada, and again, I think it's helpful for this committee to understand the responsibility Health Canada does have in this area. The Health Products and Food Branch administers the current regulatory framework that governs health product advertising. The Food and Drugs Act substantially prohibits the advertising of prescription drugs to the general public. However, that is permitted to health professionals. The Food and Drugs Act, however, does permit reminder ads. Reminder ads contain the name, price, and quantity of a particular drug but may not mention the disease or ailment it is intended to treat. In practice, reminder ads limit themselves to the name of the drug with some kind of lifestyle image, but price and quantity cannot be mentioned.

    The second permitted category of ads is help-seeking messages. These are more akin to public service messages than to traditional advertising. They describe an ailment and encourage the consumer to talk to their doctor or their health care professional about the different treatments that are available. Help-seeking ads cannot contain the name of the drug the advertiser would like the doctor to recommend.

    It should be noted that internationally only the United States and New Zealand currently permit direct-to-consumer advertising of prescription drugs. We're aware that there is a long-standing debate concerning direct-to-consumer advertising. For Health Canada and the Health Products and Food Branch, I want to emphasize that the paramount priority within this debate is and will continue to be the health and safety of Canadians. Dr. Turner will inform you of the work the branch is currently undertaking in this area to bring a more modern approach to advertising, one that meets the needs of Canadians.

[Translation]

    Madam Chair, Health Canada is committed to making significant, lasting improvements to the regulatory process to ensure that Canadians enjoy timely access to safe, effective prescription drugs.

[English]

    We are pleased to be part of your committee process and look forward with interest to the committee's findings.

[Translation]

    I'll conclude on that note, Madam Chair. Dr. Chris Turner will now speak to the committee about post-market monitoring and assessment and direct-to-consumer drug advertising. Thank you.

[English]

    The Chair: Thank you, Ms. Gorman.

    Dr. Turner.

    Dr. Christopher Turner (Director General, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health): Thank you for the opportunity to address the committee this morning. I'll be focusing my remarks on the following elements within the scope of your terms of reference: monitoring of adverse effects and prescribing practices, which includes post-market assessment and surveillance activities and the regulation of drug advertising, including the topic of direct-to-consumer advertising.

    You should have been given two slide decks, and those were translated. The speaking notes were not translated, but the slide decks were. One is entitled “Monitoring of Adverse Effects and Prescribing Practices”, and the second relates to direct-to-consumer advertising.

    I'm just concerned in terms of the complexity of this issue. But I understand your concern, so I'll try to modulate my speaking. I'm famous for talking fast, so it's not just you that I'm doing it to.

    The principal component activities of post-market surveillance of marketed therapeutic health products consist of, first of all, the promotion of the reporting of adverse effects, medication incidents, and therapeutic effectiveness; second, the monitoring of these reports through report collection processing and signal generation; third, risk and therapeutic benefit assessments; fourth, the communication of risk and therapeutic benefits; fifth, risk mitigation through a variety of market interventions, ranging from strengthened product information on labels or in product monographs to the extreme of removal from the market; sixth, risk prevention through a combination of interventions; and seventh, collaboration with other domestic and foreign stakeholders in information sharing and decision-making.

    Considerable consultation and collaboration among various stakeholders, including consumers, patients, health professionals, academics, industry, and domestic regulators, is necessary to accomplish successful post-market surveillance in this complex market, involving, as Ms. Gorman said, more than 24,000 marketed health products, being drugs, and over 50,000 licensed medical devices and many more unlicensed. It's also important to note that international collaboration is useful to augment information from the relatively small Canadian population, especially in identifying very rare adverse effects, as well as in synchronizing regulatory actions in various countries. Compliance and enforcement activities also form a crucial part of the post-market surveillance of marketed therapeutic health products.

    On the second slide in the slide deck on adverse effects, the scope of therapeutic health products undergoing post-market surveillance activities is shown and includes pharmaceuticals as well as many other individual therapeutic health products and their interactions with other products and food.

    The third slide gives example numbers of domestic and foreign case reports to Health Canada for drug products. Statistics concerning suspected adverse effect and problem reports for medical devices, immunization scheduled vaccines, medication incident, and medical error are also available and highlight the volume of reports that must be processed and used to augment market authorization holder, health professional, and academia efforts to improve the completeness of the safety and therapeutic effectiveness profiles for this wide range of therapeutic health products.

    The next slide outlines the current principal sources of suspected adverse event report information, with health professional, consumer, and patient reporting being a voluntary program and market authorization holder reporting being a mandatory program. The department currently administers five adverse reaction regional centres as well as the national centre in Ottawa.

    The next slide outlines the principal reasons why adverse reaction reporting is important in increasing information about the real life risks and therapeutic benefits of therapeutic health products, including the awareness that 51% of newly approved therapeutic health products have serious side effects identified only after approval and marketing due to greater exposure. As well, the importance of international collaboration to augment domestic information is noted.

    Slide 6 lists some limitations around adverse reaction data, including the difficulty in proving causality of a suspected reaction by any one drug. An example would be a reaction in a very sick patient with multi-organ disease in an intensive care unit who is receiving as many as 20 medications. Proving which product or disease actually caused a suspected reaction can be impossible until a series of cases reveals an apparent trend or signal.

    The current basis of post-market surveillance on spontaneous reporting by consumers and health professionals has these well-known limitations. It is for these reasons that internationally industry and regulators are looking for more comprehensive and systematic approaches to strengthen the ability to identify risk and therapeutic effectiveness characteristics of marketed therapeutic health products.

¿  (0920)  

    Reference was made in this committee on Tuesday to the MOXXI Project, otherwise known as the Medical Office of the Twenty-First Century. Conducted in the province of Quebec, it is an example of several similar projects attempting to use electronic health records and computer-based access to information on risks to prevent prescribing problems as well as to provide more systematic sources of new safety information. Health Canada is aware of and involved with several such national and foreign projects toward 21st century post-market surveillance and good pharmacovigilance practice, and is working toward innovation in these areas with a variety of industry, patient advocacy, and foreign regulatory partners. Also, forthcoming legislative renewal consultations will consider any needed regulatory instruments to accomplish post-market surveillance through a new Canada health protection act.

    Slide 8 lists some examples of current international harmonization and cooperation activities to leverage work in post-market surveillance by the International Conference on Harmonization for drugs, the Global Harmonization Task Force for medical devices, and individual foreign regulators as well as the WHO.

    Slide 9 lists some challenges to post-market surveillance, including issues of access to and use of personal health information for public health purposes, the universal under-reporting and poor quality of reports by consumers and health professionals, the sheer volume and complexity of the work, the inappropriate use and often sensationalization of the information, the difficulties of synchronization of risk identification and risk management in multiple international jurisdictions, and the role of a relatively small Canadian population in detection of new rare signals.

    In addition to adverse event and product problem reporting, some other examples of post-market surveillance activities are listed on slide 10. They identify a variety of example sources of risk and therapeutic effectiveness information that can be integrated and leveraged to strengthen product information and enable informed decision-making by consumers and patients.

    Remembering Health Canada acts principally at a population level, and individual decisions such as local use are under provincial and territorial jurisdiction, such as the practice of medicine, pharmacy, complementary medicine, and nursing, among others, collaboration with, for example, the federal-provincial-territorial common drug review process in sharing of information is another activity of the department. Health Canada sees a role in facilitating access to information, which is principally the responsibility of the market authorization holder to produce concerning their products.

    Over the last couple of years, several initiatives to increase direct access to new and comprehensive information on marketed therapeutic health products have been done. Examples include revising the product monograph guideline to clarify the need for consistent patient information section in plain language, web posting of health professional communications and public advisories, strengthening the It's Your Health communications, increasing local promotion of safe medicines use by adverse reaction regional centres, implementation of toll-free telephone and fax lines for consumer and health professional reporting, and creation of a list for real-time notification of consumer and health professional subscribers of new information generated by industry, academia, or regulators.

    There are, again, challenges to get the right message to the right individual at the right time. We are attempting to involve stakeholders in planning how to strengthen risk communication by industry and Health Canada. A second national workshop was held in March 2003 to work on solutions to encourage behaviour change toward more appropriate use of new information of marketed therapeutic health products. As well, a national survey has recently been done of consumers, health professionals, and media to see how they would best receive new information on marketed therapeutic health products.

    Monitoring of prescribing practice is another challenge. The department uses a variety of domestic and foreign commercial and government information sources to enable some understanding of prescribing practice and to enable benefit-risk assessments to be done. Again, 21st century electronic data sources are key to such activity and form part of the strategy toward strengthening federal post-market surveillance activities.

    In addition, the federal-provincial-territorial initiatives concerning the national prescription drug utilization information system, best practices in prescribing and utilization, and the Canadian Coalition on Medication Incident Reporting and Prevention will enable more informed evidence-based analysis concerning national prescribing practice patterns.

¿  (0925)  

    In conclusion, in this section, post-market surveillance is a complex activity whose responsibility is shared among many domestic and foreign stakeholders.

    If I have time, I hope to move to the topic of advertising regulation. Are we still okay with time?

    The Chair: Yes. This is exactly the information we're looking for.

    I would ask you to slow down a bit.

    Dr. Christopher Turner: Even more? You have no idea what you're asking. The regulation of drug promotion and advertising has a long history in Canada. This is the second slide deck.

    The overriding objective has always been to protect Canadians from injury to their health. The current advertising regulatory framework in the Food and Drugs Act and regulations starts with the definition of advertisement found in section 2:

“advertisement” includes any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device;

    Sections 5, 9, 10, and 20 of the current act make it an offence to advertise a food, a drug, or a medical device in a deceptive manner.

    Currently, there are three main limitations under the 1953 Food and Drugs Act to control the advertisement of drugs to the general public. Although the focus is usually on the advertisement of prescription drugs, those drugs found in what's known as schedule F, the controls on prescription drugs cannot be viewed in isolation from the controls that are in place for all therapeutic products.

    Let me walk through the three major limitations listed on this slide, one at a time. The oldest limitation dates back to the 1930s, and it was put in place to protect people from snake oil salesmen who would promote dangerous treatments and promise cures for diseases that had no cures. So schedule A of the Food and Drugs Act lists 40 diseases and disorders for which treatments, preventions, or cures cannot be advertised to the general public. Examples include cancer and alcoholism, among others. Don't ask me to list all 40; I can't remember them, so I have to look them up each time. The applies not only to drugs but also to foods, cosmetics, and devices.

    The second control, which is on the next slide, is the treatment given to schedule F drugs, in other words, to prescription drugs. In 1949, a complete prohibition was placed on the advertisement of prescription drugs to the general public. In 1978, this was modified in order to encourage price comparisons by consumers. The relevant section of the Food and Drugs Act and regulations now reads--and it's on the slide--“Where a person advertises to the general public a Schedule F Drug,”--in other words, a prescription drug--“the person shall not make any representation other than with respect to the brand name, proper name, common name, price and quantity of the drug.”

    The next slide, and the last limitation, is the deception provision contained in the Food and Drugs Act, subsection 9(1). It deals with all drugs, both prescription and over-the-counter drugs. There are similar provisions in the act for foods and devices, but not for cosmetics.

    So even when you are able to advertise a product, the advertisement cannot be deceptive, but it is important to appreciate that the onus is always on Health Canada to prove, beyond a reasonable doubt, that a health claim is deceptive and misleading or false, and that can be difficult to do at times.

    So there are the three major controls on the advertisement of prescription drugs, but certain advertising of drugs is permitted, as Diane has mentioned. Advertising of prescription drugs is permitted if direct to health professionals. There is a voluntary pre-clearance system that is managed by the Pharmaceutical Advertising Advisory Board, or PAAB, which is a multi-stakeholder board. The advertisement of non-prescription drugs to the general public is overseen by Advertising Standards Canada, or ASC, again as a voluntary system. Like the PAAB, it pre-screens proposed advertisements and responds to consumer complaints.

    There are also two varieties of promotions for prescription drugs that are permitted to be directed to the general public. These include reminder ads, which include name of drug, price, quantity, but no disease state; and help-seeking messages, which can include the name of an ailment, but no brand name of a drug that is recommended for that ailment. These are like public service messages.

¿  (0930)  

    Most of the direct-to-consumer advertising debate takes the form of arguments and counter-arguments. An example is in “Letters to the Editor” in the Toronto Star over the past week, most recently with one from the co-chair of the Best Medicines Coalition on September 17. Denis Morrice cautions about the need for a balance between advertising and education for all pharmaceutical products and the need for a debate on the issue with consumers and patients at the table. The Health Products and Food Branch research initiative into the impact of direct-to-consumer advertising on health, on medicalization--for those who don't know, medicalization is making it that there is a pill to cure everything, rather than really needing a pill in the traditional sense of a drug--and on health care systems builds on previous consultations and research, including the health transition fund project released in February 2002, which assessed the health system impacts of direct-to-consumer advertising of prescription drugs as well as other evidence from literature and international comparisons.

    Efforts have been directed at improving access to credible sources of timely drug information by patients and health professionals. An example project is the revision of the product monograph guideline, which will have a designated section for patient information. Work is underway to increase the availability of these more user-friendly patient information formats; in other words, to replace a need for advertising with access to easily understood patient information leaflets.

    Another project underway is regarding changes to the schedule A limitation on advertising. In November 1998 your committee tabled the report “Natural Health Products: A New Vision.” It contained 53 recommendations, including the creation of a Natural Health Products Directorate, which has been done.

    Recommendations 35 and 36 dealt with schedule A. They concerned how diseases find their way onto and off the list and also a recommendation that Health Canada conduct a study with the participation of representatives from consumer groups, the food, natural health products, and pharmaceutical industries, and health practitioners to determine whether subsections 3(1) and 3(2) of the Food and Drugs Act, or all of the diseases listed in schedule A, should be deleted. That study is now taking place and a working group of stakeholders has been meeting since April of this year. The minutes of their meetings are available on the Health Canada website.

    In addition, work is ongoing to assess how best to safeguard the health of Canadians through the proposed new Canada Health Act. The forthcoming consultations on legislative renewal will include discussions regarding the proposed new regulatory framework for therapeutic health product advertising.

    In conclusion, Health Canada will be following the proceedings of this committee's study into prescription drugs very carefully over the months ahead to ensure that what is heard and discussed here will assist us in our work concerning post-market surveillance and advertising regulation of marketed therapeutic health products.

    That concludes my remarks.

¿  (0935)  

    The Chair: Thank you, Dr. Turner.

    We'll go now to Ms. Pieterson.

    Ms. Beth Pieterson (Director General, Drug Strategy and Controlled Substances Programme, Healthy Environments and Consumer Safety Branch, Department of Health): Madam Chairperson and committee members, we'd like to thank you for inviting us to speak with you today about misuse and abuse of and addiction to prescription drugs. Before we answer any of your specific questions, I would like to take a few minutes to provide you with information on the overall mandate of the drug strategy and controlled substances program, including the legislative framework in which it operates. We will also provide you with an overview of the program's activities in the area of misuse and abuse of and addiction to prescription drugs.

    As you know, the government announced in May of this year new funding for Canada's drug strategy. The program's work on misuse and abuse of prescription drugs is included within the drug strategy framework. The drug strategy and controlled substances program was created in July 2000 as a result of Health Canada's realignment exercise and resulted in the joining of the regulatory and health promotion aspects of controlled substances. The key activities of the program include leading and coordinating the drug strategy within the federal government, administering the Controlled Drugs and Substances Act and its various regulations, and promoting initiatives that reduce and prevent the harm associated with these substances as well as alcohol. The program also provides expert advice and drug analysis services to the law enforcement agencies across the country.

    The program is responsible for the management of the Controlled Drugs and Substances Act and its regulations, as I just said, and this act and its regulations restrict the use of scheduled drugs to medical and scientific purposes. The various regulations include the narcotic control regulations, the benzodiazepine regulations, and the precursor control regulations. Also included are regulations for the commercialization of hemp and the use of marijuana for medical purposes.

    The Canadian regulatory regime around controlled drugs derives principally from the direction given in three United Nations drug conventions that have been ratified by Canada. This Canadian regime is designed to keep the drugs within a legitimate medical supply system, ensuring that the legitimate medical and scientific needs of Canadians are met and ensuring accountability of those handling the drugs.

    The result is that the regime utilized in Canada is similar to that used in other countries. Narcotic and most psychotropic drugs are scheduled in these three UN conventions, and Canada, having ratified them, has an obligation to meet all of their requirements.

    As already stated, these UN conventions restrict the use of scheduled drugs to medical and scientific use. While some scheduled drugs have no medical use—LSD being an example—others can be prescribed by licensed medical practitioners to treat a medical condition.

    All scheduled drugs require import-export controls, while those manufacturing, distributing, and importing and exporting them must be licensed.

    To further clarify this program's role versus that of my colleagues who just presented to you from the Health Products and Food Branch, their branch is responsible for the drug approval process, including the post-market surveillance, as well as provision of information about drug safety. Regulations in support of these activities are included in the Food and Drug Act and its regulations. The Controlled Drugs and Substances Act includes an additional layer of safeguards for those therapeutic drugs that have already gone through the drug approval process that have a potential for misuse and abuse.

    Before drugs are added to the schedule of the international conventions, the World Health Organization provides medical and scientific advice on the appropriateness of such action. While this advice is not binding on those countries who vote to add them or delete them or reschedule a drug under the international control, it is provided to all countries and seriously considered by those voting.

    After a drug is scheduled by the United Nations, Canada would add it to the schedules of the Controlled Drugs and Substances Act. Substances are not always scheduled by the UN first. In some cases Canada acts alone and prior to the UN acting. For example, Canada scheduled GHB, commonly referred to as the date rape drug, prior to receiving UN direction. We've also initiated the scheduling of the precursor to this substance, and again we've done this prior to getting direction from the United Nations.

    I now will go into talking a bit about what we're doing about misuse and abuse of prescription drugs currently.

    The drug strategy and controlled substances program is aware of the various issues and concerns regarding narcotic and controlled prescription drugs that have been raised by provinces, stakeholders, and the House of Commons Special Committee on Non-Medical Use of Drugs. Some of you participated in the House of Commons special committee. This committee made two key observations and two recommendations specifically dealing with prescription drugs.

¿  (0940)  

    In summary, the committee observed, first, that some jurisdictions did not have the capacity to detect any potential misuse of prescription drugs, and second, that in some jurisdictions pharmacists and physicians are consulting informally about the potential cases of misuse and abuse by patients. Based on these observations, the committee recommended that Health Canada, as part of the renewed drug strategy, develop a strategy specifically aimed at finding solutions to the misuse problem. The second recommendation was for the Government of Canada to assist the provinces and territories in the development of real-time databases in order to better track the prescribing and monitoring of commonly abused prescription drugs.

    The renewed Canada's drug strategy has provided some new funding to initiate partnerships and implement targeted activities in the area of prescription monitoring. For example, we'll be developing a guidance document for health care professionals to assist them in preventing substance abuse and misuse. In addition, we've begun to meet with provincial physician and pharmacy licensing bodies to discuss their concerns and their views on how we can assist them. One way would be to facilitate the sharing of best practices amongst the provinces and territories with regard to databases used to monitor and track prescriptions.

    The renewed drug strategy has also provided funding for public education and health promotion activities. We will be meeting with stakeholders over the next year to establish a national prevention agenda, and the misuse of prescription drugs is a topic that will likely appear on the agenda. The strategy will also fund community initiatives in the area of treatment, prevention, and harm reduction. Innovative community projects that target misuse and abuse of prescription drugs will be eligible for funding when the funding program starts in the next fiscal year.

    Another activity that we are currently involved in is renewing our compliance and enforcement strategy. Under the Controlled Drugs and Substances Act, Health Canada has the authority to inspect a number of facilities such as hospitals, licensed dealers, and pharmacies. The purpose of these inspections is to verify compliance with regulatory requirements and other terms and conditions, to ensure drug accountability, and to detect and investigate possible diversions.

    You should be aware that Health Canada's mandate does not include regulating the professional activities of physicians, pharmacists, and dentists. This is the responsibility of the provincial and territory licensing bodies. If these bodies discover an issue of non-compliance with the Controlled Drugs and Substances Act, they can refer it to Health Canada for further investigation.

    In conclusion, I would like to highlight that the area of misuse and abuse of and addiction to prescription drugs is complex and that responsibilities are shared among several stakeholders, such as provincial governments, licensing authorities of pharmacies, physicians, dentists, and veterinarians, as well as the pharmaceutical industry. Each has different responsibilities and may play a role in regulating and educating health care providers and patients.

    As part of the renewed drug strategy, we will be consulting with relevant stakeholders to discuss the need for new strategies for the reducing of misuse and abuse of and addiction to prescription drugs.

    I would like to thank you again for the opportunity to speak. My colleague and I will be pleased to answer any of your questions.

¿  (0945)  

    The Chair: Thank you, Ms. Pieterson.

    We'll now move to the members of Parliament. I notice Dr. Grant Hill has reappeared at the health committee after being absent for a number of years. He was not able to stay for the duration this morning, but we welcome him.

    And our newest member of Parliament, Mr. Gilbert Barrette, is joining us. I don't know whether it's on a permanent basis or whether it's a sort of investigatory visit.

    Mr. Gilbert Barrette (Témiscamingue, Lib.): It's supposed to be permanent.

    The Chair: You hope it to be permanent. We hope it is, too.

    We'll now move to Mr. Merrifield.

    Mr. Rob Merrifield (Yellowhead, Canadian Alliance): Thank you for coming in and sharing a little bit about what you do and how you are doing it. I have some questions about the details of the internal workings of your departments, but I fear going into those because of the time delay, and they are not as significant as some of the questions I do want to get to.

    You talk a lot about your job as being surveillance of the misuse of prescription medication, and that's fine. I want to know a little bit about what you've found rather than what you're doing. We know broadscale what you're doing. What have you found in the area of misuse of prescription medications?

    Ms. Beth Pieterson: I'll be quite honest: we don't have hard facts. When the drug strategy was renewed, one of the issues identified both by the Auditor General and the Senate report and the House of Commons report was that there was a lack of hard data about whether it's illicit or licit drug misuse and abuse in Canada. As part of the drug strategy, we are initiating surveys and the research work to find hard data.

    We certainly know from talking to stakeholders anecdotally that there are problems—I think the east coast one is the one most people are familiar with: the issue about the diversion and misuse of prescription narcotic drugs on the east coast—and from speaking to health care practitioners in the field of addiction medicine, where they have many patients who are not addicted to street drugs but are actually addicted to prescription drugs. But again, we don't have the hard data to support these anecdotal stories.

    Mr. Rob Merrifield: That's actually alarming to me, specifically when some of the—let's call them rumours for now—that we get are about the amount of addiction to prescription medication in our native populations, which we as a federal government have direct responsibility for with the national pharmacare program. Do we know from their example what kind of data we have on addiction to prescription medication even within that specific group?

    Ms. Beth Pieterson: Again, I have to say that the hard data is not there now, but we've initiated surveys and the work to gear up with the hard data. In the new drug strategy—I think you were involved somewhat—we laid out clear objectives. One of the objectives for the first year was to get the baseline data on the prevalence of misuse and abuse of drugs, including prescription drugs, in the first year. Then we could measure progress against it. It's the first year now, and we're gearing up to start the surveys to gather the data.

¿  (0950)  

    Mr. Rob Merrifield: Let's go back a little bit, then, because if you don't have the data, what alarms me a little is when I see how you're collecting the data. You're saying you have different stakeholders: you have the international community; you have the provinces, hopefully—you're working hand in glove with them, I would assume, because I know they have specific data on some of these issues, varying from province to province--and I'm sure you're talking to the physicians and pharmacies and so on. But I don't see mandatory reporting of adverse reactions as part of where you're going from the physician side. Is that something you are looking at or would like to see, or do you want to gather more information before you look at mandatory reporting? I see here it's just voluntary reporting on the side of those who are serving in the front lines.

    Dr. Christopher Turner: Perhaps I could address that.

    The issue of mandatory reporting has been raised in Parliament and in many other venues. It's controversial in that there are beliefs, more than hard data, as to the benefits and values of it. Part of the reason for including limitations of the current systems in the information I provided was so that it's clear there is an awareness that there are limitations.

    We have, for example, done a survey of countries where there is legislated mandatory reporting of adverse reactions by health professionals. Those countries—the most prominent one being France, because France has a very well-known system of federal organization of its medical system and a network of 20-odd regional pharmacovigilance centres that work in hospitals very closely, hand in glove, with health professionals to facilitate reporting by them—will say that the institution of legislated mandatory reporting didn't make a difference to the quality or the timeliness of signal generation.

    The reason for that is that health professionals all around the world are too busy to report. They need facilitation of that reporting. For that reason, as was discussed yesterday at the committee where there was a question asked about the MOXXI program—the Medical Office of the Twenty-first Century—in the U.K. there's the general practice research database; in other words, more systematic electronic maintenance of records, such that the information can be got systematically. The individuals who are entering that information into their office systems are resourced to do it and provided with systems that enable and facilitate it. That enables regulators to use the information to then identify more systematically and comprehensively whether there is a problem and what the practice pattern of use is on a national basis, rather than relying on somebody to take the initiative to make a report, be it a consumer or health professional.

    In other words, mandating them to do it isn't going to work, because you can't force them to fill out the form. If they don't have the time or energy to do it, they won't. In addition, because practice of medicine, pharmacy, nursing, etc., is provincially regulated, the federal government in the present situation doesn't consider that we can go into a doctor's office and in some way force them—or in other words, do compliance and enforcement action against them—for not reporting.

    Mr. Rob Merrifield: Before my time gets cut off, I want to follow through a little. Your saying that mandatory reporting will not work really alarms me.

    Dr. Christopher Turner: I'm saying it doesn't necessarily make a difference.

    Mr. Rob Merrifield: Let's say you find out that you have abuses to the prescription—because Health Canada has, on lots of your pharmaceuticals, recommendations as to how they are to be prescribed. If a physician is not prescribing in accordance with Health Canada, which follows under your mandate as well, what powers do you have? What do you do about it? How are you following through on that? You're saying even concerning adverse reporting you have no mandate to be able to go in and require it. Well, what are you doing with prescribing?

    Ms. Diane Gorman: I think it might be helpful to separate out the responsibilities we do have and the interventions we can make.

    If, for example—and now I'm not talking about the abuse of prescription drugs; I'm talking about the fact that we might pick up through post-market surveillance that a particular product is having an adverse reaction that was never intended and may find that what has happened, in fact, is that doctors are prescribing what we call “off label”—people are using a product that was intended for a purpose for another purpose and we're seeing certain reactions, we have several measures we could take. One is to send out a notice to health care professionals to say we remind them this was the intended use of the product. We could have additional warnings on the label. We could put out more information to consumers.

    So we do have certain tools we can use, but if prescribing practices are not being appropriately applied by individual doctors, it is their licensing colleges that would have a responsibility to deal with that.

¿  (0955)  

    The Chair: Thank you, Mr. Merrifield.

    We now have about a minute left for Ms. Hinton.

    Mrs. Betty Hinton (Kamloops, Thompson and Highland Valleys, Canadian Alliance): Well, I can speak fairly quickly.

    What you've been saying today has been very interesting, but I have some serious concerns as well about the mandatory part of it. I believe that of course it could be made mandatory if you think it's in the best interests of Canadian patients. No doctor is going to risk being able to practise by ignoring a mandatory order to talk about adverse effects.

    I would like to ask one question here. A year and a half ago I was sitting on a completely separate committee, and there was a witness there named Mrs. Stonechild, whose concern was that she lived on a reserve and there was no control over how many prescriptions were given to her relatives. She lost both her brother and her son to overdoses of prescription drugs. I believe the brother had 200 and some odd prescriptions all in one year. I want to know if that is still what's happening. Are prescription drugs still not monitored for aboriginal people in this country?

    Ms. Carole Bouchard (Director, Office of Controlled Substances, Drug Strategy and Controlled Substances Programme, Healthy Environments and Consumer Safety Branch, Department of Health): I think I understand that the committee is going to be hearing from the specific program of Health Canada that deals with the native prescription program. And unfortunately, for sure, this is outside our area under the Controlled Drugs and Substances Act. I understand that the committee, maybe next week, is having one member from the specific program.

    Mrs. Betty Hinton: How can it be outside of your area if you're Health Canada?

    Ms. Carole Bouchard: We do have different areas within the department. We do work in partnership, but they are specific. I'm sure they will be better positioned to answer those questions than we are.

    Ms. Beth Pieterson: The First Nations and Inuit Health Branch is the branch that covers the direct provision of health care service, as well as the paying for prescription drugs for natives who live on reserves. So they are best positioned to answer your question on how those prescriptions are monitored.

    The Chair: Thank you, Ms. Hinton.

    Mr. Ménard.

[Translation]

    Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ): Thank you, Madam Chair.

    I'd like to get a better understanding of the whole issue of drug advertising and I hope this will be a focus of the committee's recommendations. First of all, I have to tell you that I strongly object to advertising in this area. I have three questions for you about this particular subject.

    First off, can you explain to me the difference between schedule A and schedule F? I understand that in the case of drugs listed in one schedule, a general ban on public advertising applies, but I'd like to know the difference between the two.

    We hear references to “permissible advertisements” and “advertisements that jog people's memory”. Take the drug Viagra, for example. I don't know if this advertisement plays on English television, but it runs quite often in Quebec. We see a postman leaping about, happily delivering the mail without apparently a care in the world. No mention is made of the drug, but I know that's it is the product being advertised. I find this type of advertising somewhat fraudulent, unless we're dealing in generalities.

    My concern - and in my view, the committee will need to delve into this matter - is that there are no regulations in place to deal with violators. What options do you have? I can understand the burden of proof weighing on you. If the Viagra case was taken to court, the outcome would be interesting indeed. What means are available to you to deal with parties that violate the rules?

À  (1000)  

[English]

    Dr. Christopher Turner: Having been here on Tuesday, I realize Mr. Ménard asks these questions in series, which is always a little more difficult to keep track of. But anyway....

    Schedule A and schedule F are actually very different things. Schedule A is a list of diseases against which you can't advertise; schedule F is the list that includes the names of all of the prescription drugs. So they're two totally separate things, but the limitations against advertising exist for both of them. As I say, the one with attention being given to it at the moment in terms of changing it most rapidly is schedule A. But as part of the legislative renewal consultations, all of the limitations will be examined.

    Your second question was essentially about medicalization, or about why one can actually advertise something or run an ad relating to either the drug or the activity. In other words, a help-seeking ad may say there are now treatments available for such and such an ailment. As long as it doesn't mention the disease, it can be advertised according to the current regulatory framework. Because name, price, and quantity can be advertised, as long as they don't associate it with a disease, or in other words, with an indication that may appear on schedule A, then they can also do that. So they can do a bit, but they can't do it all.

    To some extent, that may explain the answer to your third question relating to compliance and enforcement activities or, in other words, your question about what one can do about some of these things. It relates to the point in my presentation regarding demonstrating the risk to health. In other words, if Health Canada cannot demonstrate that the ad is deceptive or of significant risk to the health of Canadians, it's very difficult to take an action.

[Translation]

    Mr. Réal Ménard: The only available recourse is to take the matter up with common law courts. Neither the Patented Medicines Prices Review Board nor any other Health Canada regulatory body can intervene. The only party that can is the common law court of the province in which the advertisement is running.

[English]

    Dr. Christopher Turner: No, that's not really true. The Health Products and Food Branch Inspectorate, which is part of the Health Products and Food Branch, does investigate complaints against advertising, either proposed fraud or deception, or ads that may appear on bus shelters and that may suggest a particular use and indication. For example, if there's a box in an ad suggesting the product is an oral contraceptive, it may be in contravention of the current restrictions. Even though they don't say it's in—

[Translation]

    Mr. Réal Ménard: As I understand it, even though you did not state it publicly, Health Canada inspectors are responsible for enforcing the provisions of the Food and Drug Act as they relate to advertising. Which branch employs these inspectors? Approximately how many inspectors are there? Could you pass on that information to our clerk, along with the list of infractions committed over the past five years?

    You didn't mention that inspectors are on the job. That's an important detail. Do they report to your Branch?

    Ms. Diane Gorman: Yes indeed. I can obtain the information you requested and provide some clarification, but I have to tell you that these officials perform other duties as well. They must also ensure that the products sold in drugstores or at corner stores are legal...

[English]

    The Chair: Mr. Ménard, I think your time is up. You managed to work in another minute and 30 seconds, as usual, but I'm going to be more strict this year. Thank you very much.

    Ms. Bennett.

À  (1005)  

    Ms. Carolyn Bennett (St. Paul's, Lib.): In the three little areas, I guess I want to start with a question. Why do you deal with hemp when you couldn't actually...? Why doesn't Agriculture Canada deal with hemp? You couldn't roll a whole field and get anything resembling a drug, so why are you dealing with it?

    Ms. Beth Pieterson: You picked up that little word.

    I'll let Carole answer, as she knows better than I do.

    Ms. Carole Bouchard: Maybe I could add that industrial hemp is also cannabis and is currently listed under the Controlled Drugs and Substances Act.

    Ms. Carolyn Bennett: Yes, it'll be in our report. Thanks.

    Regarding the post-market surveillance piece, I have never filled out one of these forms in my life. I wouldn't even know where to begin with it. Where it says “patient identifier”, I wouldn't even know what you wanted me to do. So how many people are there like me who just never bother to go through this? That's your point, right?

    And what are we doing about patients who just stop taking the drug because they don't like the way it makes them feel? Where do they report? They never bother to come back to tell me they got diarrhea, or a rash, or whatever. So I guess my question is, how close are we to getting BlackBerry filing of these tough questions that I don't even have to answer? I just have to say that maybe it was related to the drug, but I don't know, so you nice scientists should come and help me find out. That would be a much better group of data.

    You do know that most people aren't doing this, right? That's what you said.

    Dr. Christopher Turner: Well, in actual fact, you'll be pleased to know that over the past five years, every year we've had about a 15% increase in reports. So I tend to think we're doing—

    Ms. Carolyn Bennett: Are they all from hospitals?

    Dr. Christopher Turner: No, they're from everywhere, including consumers. In fact, consumer reporting has gone from 3% to 10% to 15%, depending on the year.

    First of all, we created guidelines for health professional reporting, and posted the reports on the website, to make it easier for health professionals to understand that form.

    Ms. Carolyn Bennett: Can they e-file?

    Dr. Christopher Turner: No.

    Ms. Carolyn Bennett: Why not?

    Dr. Christopher Turner: Unfortunately, we're technologically challenged at the moment, but we're working towards that.

    Ms. Carolyn Bennett: Okay, that'll be in the report too.

    Dr. Christopher Turner: I just wanted to say that we have toll-free fax and phone lines for telephone reporting, so if someone wants to give us a call.... These lines are advertised every quarter in the newsletter you were given, the CMAJ, or the Canadian Medical Association Journal. In other words, telephone reports will be taken; the individual doesn't actually have to physically fill out the form.

    We're also doing a lot more representation through the regional centres and at health professional meetings and conferences to educate health professionals and consumers on how they can report.

    Ms. Carolyn Bennett: When you've got something and you're going to recall a drug, are you still sending a letter out by snail mail to recall drugs? So I would actually have to have patients come in and tell me what they saw on the news last night.

    Dr. Christopher Turner: For the past two years, we've been posting this information on the website, in addition to creating a listserv that alerts people in real time on their PCs that an action has been taken.

À  (1010)  

    Ms. Carolyn Bennett: So you are now starting to get a listserv of the physicians of Canada?

    Dr. Christopher Turner: Yes. We're also working with the national and provincial regulatory bodies of physicians, nurses, and other health professions to find better ways to link to their systems in real time. As a result of the recent SARS issue in Ontario and nationally, we've been working to find better ways of getting alerts to health professionals in the way they want to get them. It is being done.

    Ms. Carolyn Bennett: But with SARS we found out that thousands of doctors in Ontario didn't have e-mail, and some of them don't even have faxes.

    So do you think it's optional for the physicians of Canada to not be hooked up online?

    Dr. Christopher Turner: Again, that's provincial regulation.

    Ms. Carolyn Bennett: But how do you keep a safe drug system if you can't actually send out a real-time message?

    Dr. Christopher Turner: Well, I can tell you that in visits with other foreign regulators, especially the U.K., for example, where they have a very well organized system for getting a message out to all physicians within 24 hours, we're using that information--

    Ms. Carolyn Bennett: Wouldn't that be nice?

    Dr. Christopher Turner: Yes.

    Ms. Carolyn Bennett: Okay, that's in the report too.

    Dr. Christopher Turner: That's why we have a national conference on that. It's also why we have a project working with palm pilot developers to put that information on PalmPilots and BlackBerrys in real time, real quick. We are working on it and have made progress. We've actually completed two phases of a project with PalmPilot developers to get that information on people's belt loops, so they can actually see it quickly.

    Ms. Carolyn Bennett: That would be a good idea.

    I'm so scared of the chair that I'm--

    The Chair: You get one more question to make you even with Mr. Ménard.

    Ms. Carolyn Bennett: I want to move on to the misuse of prescription drugs. Is there not a culture that's already wrong as soon as you say misuse? Are we talking about optimal prescribing? Isn't this sometimes about education, that people are still using amitriptyline instead of the newer drugs? In terms of commonly abused prescription drugs, is that because the doctor is prescribing or the patient got addicted and is now seeing five different doctors to get the same drug? I also have trouble with patients who really have pain. How are you separating the people with real indications for taking this stuff, because they're terminally ill or this is the only thing that works, from the people who actually have an addiction problem? If they have an addiction problem, why aren't we dealing with that in a therapeutic way, saying that this is a problem they have, as opposed to using language like abuse of...? I think we aren't helping people get help if we keep framing it this way.

    Ms. Beth Pieterson: I think probably the terms “misuse” and “abuse” are used by us. When you're talking of diversion of drugs, it's no longer in a therapeutic context. We have trouble with those words too, actually. Those were the words on the agenda, so I used them. When it becomes the diversion and they're selling it on the street and people are not using it for therapeutic reasons, that's where it crosses the line.

    The Chair: We will now move to Mr. Robinson.

    Mr. Svend Robinson (Burnaby—Douglas, NDP): Thank you.

    I want to thank the witnesses for being here.

    We've embarked on a very comprehensive study here, and in seven or eight minutes I can't even begin to deal seriously with a lot of the issues we have to deal with. I feel the same sense of pressure that others have referred to.

    I just want to seek clarification through the chair. I assume that if there are other issues we want to follow up on with our expert witnesses, we can submit questions through the chair or our researchers to the departmental officials and ask them to respond in a timely manner.

    The Chair: That is the usual format, Mr. Robinson. But if, for example, you have a question and they submit to us a five-page answer, I'm wondering if it's really making an impact on everybody. Is everybody reading the answer to that question? Would it be better to book more meetings with these bureaucrats so that we actually have the face-to-face verbal responses?

    Mr. Svend Robinson: I think we can do both. There are a number of questions that obviously we won't have time to get to, but we can submit them to the witnesses.

    The Chair: Yes.

    Mr. Svend Robinson: Thank you.

    I have an ad here from the journal of the Canadian Cancer Society, and it's targeting people with cancer. It's from a pharmaceutical company, Ortho Biotech. It says: “At Ortho Biotech we understand that even the simplest day-to-day activities can be a challenge when you're going through chemotherapy. As part of its ongoing goal to better the lives of people living with cancer, Ortho Biotech has developed a treatment for chemotherapy-related anemia. Ask your doctor about this effective treatment for managing the side effects of chemotherapy and start living again.”

    It sounds like advertising to me. What's your department doing about this?

    Dr. Christopher Turner: The journal that's published in is, I believe, a health professional journal.

    Mr. Svend Robinson: No, it's the Canadian Cancer Society's newsletter.

    Dr. Christopher Turner: Is there a pre-clearance symbol from Advertising Standards Canada on that ad?

    Mr. Svend Robinson: I'm not sure if this little symbol here indicates that. I don't think so.

    Dr. Christopher Turner: No. It would usually be ASC.

    Mr. Svend Robinson: No, there's nothing.

    Dr. Christopher Turner: There's a voluntary system--

    Mr. Svend Robinson: I'm asking what you're doing. You're supposed to be enforcing the law.

À  (1015)  

    Dr. Christopher Turner: If a complaint has been made against that--if that's what you're making at the moment--then it can be investigated. We do not scan all publications, be they print, television, or the Internet, for violations. A complaint has to be made, and then it will be investigated.

    Mr. Svend Robinson: So you don't monitor journals. This is a pretty obvious thing. You're supposed to be doing your job to make sure the law is being enforced. Are you saying that the only way you do that is if somebody complains to you, and that you don't do any monitoring yourselves?

    Dr. Christopher Turner: That's true.

    Mr. Svend Robinson: That's pretty appalling, Madam Chair.

    On the face of it, does this ad sound like the kind of thing that is legal in Canada under the existing provisions of the Food and Drugs Act?

    Dr. Christopher Turner: If it were provided to me, I would give a review of it. I can tell you that in years gone by, before the voluntary pre-clearance system was put in place, there was pre-clearance done within Health Canada. I just happened to be one of the people who used to do it. We would review these ads. If we had concerns, then of course we would negotiate with the advertiser.

    Mr. Svend Robinson: I'll get the ad to you. I have to say, though, I think certainly the fact that, you're telling us, you only respond if somebody complains and that you're not doing any monitoring whatsoever is an abdication of your responsibility to Canadians.

    I hope at least you monitor the Canadian Medical Association Journaloccasionally. I'm sure you're aware of the article that was published just a couple of weeks ago with the headline, “Direct-to-consumer prescription drug advertising in Canada: Permission by default?” It's an article written by David Gardner, Barbara Mintzes, Aleck Ostry. Basically they suggest that you are allowing violations of the Food and Drug Act to occur in this country by stealth. I'm not going to quote from the whole thing--I don't have time--but I would ask that you provide a response to this committee to the very serious allegations that are made in that article, so that we can hear exactly what you have to say on it. I think it's a very serious matter.

    On mandatory reporting, I think one of the weakest areas in the whole drug approval and monitoring program is post-market monitoring and surveillance. I agree absolutely that there should be mandatory reporting. I agree with my colleagues in the Canadian Alliance. I find it extraordinary. The witnesses are saying, well, you know, doctors might just ignore the law. No, drug regulation and enforcement is federal. I'm sorry, it's not provincial. The department has the power to do this, if they want to use it.

    Ms. Diane Gorman: Perhaps, Mr. Robinson, we should clarify what authorities we do have and what authorities we do not have. There is a mandatory requirement on the part of the industry and we do enforce it.

    Mr. Svend Robinson: No, that's not what we're talking about here. We're not talking about industry. We're talking about asking doctors to report when their patients report adverse reactions. I don't think that's a particularly revolutionary concept. It certainly shouldn't be.

    Ms. Diane Gorman: I think it would also be helpful for the committee to appreciate the limitations within which we do work, as you study this issue, because I know your interests will not be limited to Health Canada, but to the other parties, and it really is a system that we're looking at.

    The other element within all of this as well is privacy. Dr. Turner alluded to that during his remarks. I won't go into that now, because that wasn't the nature of your question--

    Mr. Svend Robinson: No.

    Ms. Diane Gorman: --but I think we also have to be aware of some of the limitations within which the department works.

    Mr. Svend Robinson: Again, there is a whole series of other questions, but I have only one more.

    Regarding marijuana--I'm not going to deal with hemp--the so-called medicinal marijuana that apparently has been made available, you're aware of the fact that there have been a lot of complaints about that. People say it is pretty pathetic, that it causes nausea, that it's far too weak. We're talking about people who are suffering, in some cases suffering terribly with multiple sclerosis, and are looking for something that will make their lives a little easier. What are you doing to respond to those very serious complaints that have been made by people with respect to the marijuana that has been made available to them?

    Ms. Beth Pieterson: I'm aware that it hit the media this week big time. From our point of view, we don't necessarily agree with their analysis. We have done a lot of analysis on the product, and ours is quite different from theirs. We've asked to see their results. The person who is alleging that the product is not good refuses to share the details of the results with us. Until we see the details, we can't--

    Mr. Svend Robinson: What about the percentage of THC, for example?

    Ms. Beth Pieterson: Our testing shows it's 10%, plus or minus 1.5%, consistently by methodology done in an accredited lab, and it's standardized. They won't tell us what lab or what methods they use to test theirs.

    We have concerns, because that product is being used in clinical trials with patients now. These patients hear from some other people that the product is bad, so we're quite concerned. We didn't hear concerns about it from the people using it in the clinical trials.

À  (1020)  

    Mr. Svend Robinson: Are you following up on these concerns with the people involved in clinical trials?

    Ms. Beth Pieterson: Yes, we're following up, and we will proceed to make our testing publicly available.

    Mr. Svend Robinson: And you'll report back to us?

    Ms. Beth Pieterson: Yes, we can report back to you.

    Mr. Svend Robinson: Thank you.

    The Chair: Thank you, Mr. Robinson.

    Mr. Dromisky.

    Mr. Stan Dromisky (Thunder Bay—Atikokan, Lib.): Thank you very much.

    I'll have to make some general assumptions, which I think will contain a tremendous amount of truth.

    As far as government agencies are concerned, you people, I think you're lacking in staff and equipment, but maybe not in purpose; there's no doubt about that. However, my question is regarding reliance. Does our agency put a tremendous amount of faith in the kind of reporting that you will receive from pharmaceutical companies and the research they have done on any particular drug? How much faith do you put in it? Do you have to rely totally on it, or are you waiting for responses from other pharmaceutical companies that are competitors? Or are you waiting for test results out in the field that you manage? I don't know if you do. Are you just depending upon the test results from pharmaceutical companies?

    What kind of testing is done? How much faith do you put in the kinds of results you get from any particular pharmaceutical company pertaining to the claims they make about a drug?

    Ms. Diane Gorman: Let me start by answering that, if I might, and then I'll ask Dr. Turner to give you more detail.

    Let me check, first of all, that what you are mainly interested in is the pre-market authorization as opposed to post-market.

    Mr. Stan Dromisky: That's right.

    Ms. Diane Gorman: I know Dr. Peterson was here on Tuesday to speak to you about that as well.

    There are very few agencies in the world that actually would do the level of review that you are talking about, so there is a certain dependence, if we can call it that, in terms of the data that is brought forward by the industry.

    But they are required. There are very high standards in terms of what must be contained in submissions, very high standards in terms of the evidence they bring forward, the methodology they use to arrive at their conclusions. It's at that point that the submission enters Health Canada, and then we have an obligation to ensure that the methodology and the standards that are required have been met.

    But I'll let Dr. Turner speak more in terms of the process that we then go through within the department.

    Dr. Christopher Turner: I especially want to address your point about reliance on the manufacturer to deal with what reports are made to them. To be totally honest, I'd probably never get a job working in industry, because I think you get a very suspicious attitude, and that helps in this activity, to be suspicious. But that's one reason for a post-market surveillance program to exist; otherwise,why have a program where, on a mandatory basis, manufacturers must report to us?

    We have a program that involves going into manufacturers' establishments and making sure they're not holding onto reports, that they are reporting them to us. In addition, we facilitate consumers and health professionals reporting to us directly, and then we provide that information back to the manufacturer, requiring them to summarize that information and then make an evaluation of it. Then we will corroborate that evaluation to see if we have a concern.

    Obviously, with 24,000 drugs on the market--in fact, hundreds of thousands of medical devices--it's physically impossible to have people monitoring each of these products at all times. So you have to prioritize. You have to focus on what are apparent signals or trends. That's one reason that collaboration and partnership with both domestic and foreign partners is important, because through that method we hope to be able to hit the high points. The reality is, with so many products, there may be issues that don't come to the surface.

À  (1025)  

    Ms. Diane Gorman: Perhaps I could just clarify that Dr. Turner is talking about post-market--

    Dr. Christopher Turner: That's right.

    Ms. Diane Gorman: Clearly, we have a very rigorous pre-market system in terms of the demonstration that must be made about safety and efficacy of the product, the rigour that was gone through in the various stages of clinical trials and the data that is now being submitted to us.

    Mr. Stan Dromisky: If they're honest in that trial....

    For instance, variables might appear that are detrimental to the overall results. So it's quite easy to get rid of those variables and only report what we consider to be most acceptable and most appealing, which will lead to greater sales in the long run.

    Go ahead.

    Dr. Christopher Turner: I think what you may be referring to is the fact that there is both a publication bias towards publishing favourable results and an associated bias towards including that kind of information in a submission. But that's one reason we encourage our reviewers in both pre-market and post-market within the department to maintain some contact with the business of health care and research. Through attending conferences and reviewing literature in their area of expertise, they can get a more global view and bring that to a submission. In other words, they're not reviewing a submission in isolation from what else they know is going on in that area of science. So the rigour of the scientists who do the reviews is critical to being able to validate what the industry has submitted.

    Mr. Stan Dromisky: In light of what you've just been saying, I'm going to jump to the conclusion that the doors are wide open internationally, correct?

    Dr. Christopher Turner: I don't understand what you mean.

    Mr. Stan Dromisky: The information would flow across borders and political borders, from one pharmaceutical company or from one health agency in another country to you and to other countries of the world.

    Ms. Diane Gorman: I think you have to be precise when you talk about information. Certainly we share scientific information. We would share what is publicly known, but internationally there are also requirements to ensure that any proprietary information of the industry respects international rules.

    Mr. Stan Dromisky: I understand that.

    Now, my question is very political. Would the foreign policy of a government such as ours, for instance, interfere with that flow of information and prevent some of that information from coming in, prevent even a product from entering the country? I'm asking a question of that nature because Cuba has a huge pharmaceutical industry. Does our foreign policy prevent the health industry from tapping any of the products of that pharmaceutical industry in Cuba?

    Ms. Diane Gorman: No, it wouldn't. And another piece we haven't talked about is the establishment that actually produces products in the manufacturing process. We've talked about the pre-market, which is the submission that comes in terms of the data, the clinical trials, and so on, but the actual sites that manufacture products, which I think may be what you're referring to, also have to meet certain standards and have to be licensed by Canada. We have international agreements on that.

    So nothing in terms of trade policy or political policy would influence that, but they would have to have applied, and it may be that they do or do not choose to apply to have that product marketed in Canada.

    Mr. Stan Dromisky: If some great discovery were made in Iraq or Iran or North Korea, we would have no problem in terms of having access to that information or those products?

    Ms. Diane Gorman: Again, I think you have to separate the product from the information.

    Mr. Stan Dromisky: No, no, no, let's say--

    Ms. Diane Gorman: In order for us to review a product, the manufacturer or the proponent of that product would have to submit to Canada to have us review that product. That's one piece of it. The other piece is that if there is a breakthrough, we do have something called a special access program, which I think Dr. Peterson described the other day.

    The Chair: I'm getting indications from people, as I had it earlier from Mr. Robinson, that there is a lot more to talk about with these people. Do you want to go around again, or would you like to book a second meeting with them? At this point, next Wednesday afternoon is open. I feel I have about a hundred questions in my head.

    Do I hear another meeting? How many vote for another meeting with these people?

À  (1030)  

    Ms. Carolyn Bennett: I'd love to know from these people if there are witnesses they think we should call, particularly internationally or from other jurisdictions that actually are doing interesting things that they think we should know about. The WHO, I know, has some views on direct-to-consumer advertising, particularly for anti-tobacco products. The www.healthyskepticism.org guy in Australia has some views on that stuff.

    Would you help us figure out if there are some people who you think we should hear from, who inform your day-to-day stuff as well?

    The Chair: Do you think you might be available next Wednesday afternoon at 3:30?

    Ms. Diane Gorman: We will make ourselves available. As well, between now and then perhaps we could have some guidance in terms of the nature of questions so we can be well prepared in terms of our witnesses here.

    The Chair: Mr. Robinson.

    Mr. Svend Robinson: Sure, and this obviously doesn't preclude submitting written questions to the witnesses. In fact, we had an indication that may be helpful to them.

    Since we are going to be meeting with the witnesses next week, I will give Dr. Turner a copy of this ad. It's pretty blatant, and as I was just reminded when I looked at the note I made on it, it didn't just appear in the news out of the Canadian Cancer Society, this was an insert in the Globe and Mail. That's a nationally distributed newspaper, and from what I'm hearing, this department isn't even monitoring that. So I'd like you to look into this and come back to the committee next week.

    The Chair: Mr. Ménard.

[Translation]

    Mr. Réal Ménard: Could you possibly obtain the information I requested concerning other infractions committed and the overall number of inspectors on duty, to shed more light on this matter?

[English]

    The Chair: And I'd like some answers with regard to the number of people who are sitting at the end of that telephone line waiting for adverse reaction reports. I must say, I was extremely excited to see that, because I actually have people who come to my constituency office telling me about adverse reactions. They don't know what to do about it, and up until seeing that phone number, I hadn't really known myself. I had just referred them back to their own doctors.

    Are you really advertising that number? And if you do, how many people do you have to respond? I'd like some details on that, and on anything that has to do with inspections or reception of bad news, the numbers of staff persons assigned to that.

    Mr. Svend Robinson: Sorry, Bonnie, I should have mentioned a minute ago that I did ask that we get a response to the article in the journal of the Canadian Medical Association as well. Perhaps we could have that for next week as well.

    Mr. Stan Dromisky: And can copies be distributed to all the members?

    The Chair: Yes.

    If you have any more formal questions you can think of in the next day or so, I suggest you get them to José by, say, Friday afternoon. By Monday he could get them to Diane and her team, and they'd have some time.

    Of course, the questions we ask will not be restricted to what we submit in the sense that sometimes things said by our colleagues or in your answers can spur on other questions.

    Ms. Diane Gorman: No, we appreciate that. As well, as we see those questions, I would ask that, if there are more appropriate witnesses, we ensure that they are here, because I don't think it's helpful to you if our answer is, “I'm sorry, we don't have that information.”

    The Chair: Thank you very much.

    Mr. Rob Merrifield: Madam Chair, I'd like to follow up on what you were saying with a personal experience that I'm quite concerned about.

    I actually sent you a letter from my office, alerting you to a negative reaction in a constituent who contacted us. This was July 2, and we didn't get a response back from you until September 11. That was over two months, and yet it was a significant reaction. I didn't bring that up earlier because it's internal stuff, and I wanted to talk on the broader issues, but it follows up on what the chair was asking.

    The Chair: Ms. Hinton also would like to throw something on the table for you to consider.

    Mrs. Betty Hinton: You've asked for a heads-up, so I'd like to give you one.

    With the permission of the chair, I would like to suggest to you that since there seems to be a lack of communication between one level and another level regarding the aboriginal issue and the prescription drug issue, you might want to bring along a colleague who can answer those questions. I have some very serious concerns about the number of aboriginal people in this country who are dying because of overdoses.

    The Chair: They're coming on Thursday, that particular group, but you might alert them to Ms. Hinton's very precise concern.

    Mr. Robinson.

À  (1035)  

    Mr. Svend Robinson: Just to give another heads-up, I wonder if we could also get next week an update on the status of the consent form issue, the native health branch requirement for first nations people. As you know, there was a great deal of concern around this issue of a consent form. It was supposed to come into force September 1 but has been postponed.

    The Chair: Mr. Robinson, I think it probably would be better if our own researchers alerted the first nations representatives who are coming from First Nations and Inuit Health Branch .

    Mr. Svend Robinson: I'm asking the department, though, to give us an update on the current status. They've postponed implementation, and I just want to know where that's at and what kind of consultations are under way.

    The Chair: But those people are actually coming next Thursday.

    Mr. Svend Robinson: But that's the first nations people.

    The Chair: First Nations and Inuit Health Branch.

    Mr. Svend Robinson: Oh, it's First Nations and Inuit Health Branch.

    The Chair: Yes. So they would be the people, I believe.

    Mr. Svend Robinson: Okay. That's fine.

    The Chair: I don't want to preclude anybody, but on the other hand, I would prefer that if you have further questions around these subjects, you flow them through José. If you would agree to do that, we could close this section of the meeting.

    We need another few minutes to talk about our touring to hear witnesses.

    So thank you very much, Dr. Turner, Ms. Gorman, Ms. Pieterson, and Ms. Bouchard.

    We know we're into a very complex issue here. I would like to reassure my colleagues that I have no intention of rushing through this. I have a feeling this going to be as complicated as was reproductive technology. Every group we hear from will add another layer of complication. When one considers the presence of the private sector and pharmaceutical companies in this game and the presence of health care professionals, who are regulated provincially, you can see that this is not going to be an easy topic.

    So I have no intention of rushing through it but rather taking our time. It would not surprise me if this study ended up taking two years. I hope it doesn't, but I'm just saying that if more and more things turn up.... So I am looking at it from the point of view that we should be thorough and make sure we all understand and that we've internalized some of the jargon, for example, so that we can talk intelligently about it as we go through this.

    [Proceedings continue in camera]