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37th PARLIAMENT, 2nd SESSION

Standing Committee on Health

EVIDENCE

CONTENTS

Thursday, October 30, 2003

0905

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

Dr. Edward Keystone (Associate Clinical Director, Canadian Arthritis Network)

0910

The Chair

Dr. Kenneth Chapman (President, Canadian Network for Asthma Care)

0915

0920

The Chair

Ms. Durhane Wong-Rieger (President and Chief Executive Officer, Anemia Institute for Research and Education)

0925

0930

The Chair

Ms. Donna Lillie (Vice-President, Research and Professional Education, Canadian Diabetes Association)

0935

The Chair

Ms. Louise Binder (Chair, Canadian Treatment Action Council)

0940

0945

The Chair

Ms. Louise Binder

The Chair

Mr. Rob Merrifield (Yellowhead, Canadian Alliance)

Dr. Edward Keystone

Mr. Rob Merrifield

Dr. Edward Keystone

Mr. Rob Merrifield

Dr. Edward Keystone

Mr. Rob Merrifield

Ms. Durhane Wong-Rieger

0950

Dr. Kenneth Chapman

Mr. Rob Merrifield

Dr. Kenneth Chapman

Mr. Rob Merrifield

Dr. Kenneth Chapman

Dr. Edward Keystone

Mr. Rob Merrifield

Dr. Edward Keystone

Ms. Durhane Wong-Rieger

Mr. Rob Merrifield

Ms. Durhane Wong-Rieger

Mr. Rob Merrifield

Dr. Kenneth Chapman

Mr. Rob Merrifield

Dr. Kenneth Chapman

Mr. Rob Merrifield

Dr. Kenneth Chapman

Mr. Rob Merrifield

Dr. Kenneth Chapman

Dr. Edward Keystone

Mr. Rob Merrifield

0955

Ms. Louise Binder

Mr. Rob Merrifield

Ms. Louise Binder

Mr. Rob Merrifield

Ms. Louise Binder

Mr. Rob Merrifield

The Chair

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

Ms. Durhane Wong-Rieger

1000

Ms. Carolyn Bennett

Ms. Durhane Wong-Rieger

Dr. Kenneth Chapman

Ms. Donna Lillie

The Chair

Ms. Donna Lillie

Dr. Edward Keystone

The Chair

Mr. Jeannot Castonguay (Madawaska—Restigouche, Lib.)

1005

Dr. Kenneth Chapman

Mr. Jeannot Castonguay

Dr. Kenneth Chapman

Ms. Donna Lillie

Dr. Edward Keystone

The Chair

Mr. Gilbert Barrette (Témiscamingue, Lib.)

1010

Ms. Donna Lillie

Mr. Gilbert Barrette

The Chair

Dr. Edward Keystone

The Chair

Dr. Kenneth Chapman

1015

The Chair

Ms. Durhane Wong-Rieger

The Chair

Mr. Mel Fruitman (President, Consumers' Association of Canada)

1035

Ms. Joan Sayer (Provincial Liaison to the National Health Council, Consumers Association of Canada)

1040

The Chair

Mr. Gord Thow (Past President, Canadian Cystic Fibrosis Foundation)

1045

1050

The Chair

Mr. Al Gorlick (Chair, Alliance of Seniors to Protect Canada's Social Programs)

1055

1100

The Chair

Mr. Al Gorlick

The Chair

Mr. Rod Bezo (Canadian Coordinator, Steelworkers Organization of Active Retirees, United Steelworkers of America)

Mr. Jorge Garcia-Orgales (Researcher, United Steelworkers of America)

1105

1110

The Chair

Mr. Jorge Garcia-Orgales

The Chair

1115

Mrs. Joyce Gordon (President and Chief Executive Officer, Osteoporosis Society of Canada)

Ms. Gail Lemieux (Founding Member, Canadian Osteoporosis Patient Network, Osteoporosis Society of Canada)

1120

Ms. Joyce Gordon

The Chair

Mr. Rob Merrifield

1125

Mr. Al Gorlick

Mr. Rob Merrifield

Mr. Al Gorlick

Mr. Rob Merrifield

Mr. Al Gorlick

Mr. Rob Merrifield

Mr. Al Gorlick

Mr. Rob Merrifield

Mr. Al Gorlick

Mr. Rob Merrifield

Mr. Al Gorlick

Mr. Rob Merrifield

Mr. Al Gorlick

The Chair

Mr. Gilbert Barrette

Ms. Joan Sayer

1130

Mr. Gilbert Barrette

The Chair

Mr. Svend Robinson (Burnaby—Douglas, NDP)

Ms. Joyce Gordon

Mr. Svend Robinson

Dr. Josée Chiarot (Director, Medical/Scientific and Community Programs, Canadian Cystic Fibrosis Foundation)

1135

Mr. Svend Robinson

Dr. Josée Chiarot

Mr. Svend Robinson

Ms. Joyce Gordon

Mr. Svend Robinson

Ms. Joyce Gordon

Mr. Svend Robinson

Mr. Mel Fruitman

Mr. Al Gorlick

Mr. Svend Robinson

Mr. Al Gorlick

The Chair

Mr. Svend Robinson

Mr. Al Gorlick

Mr. Svend Robinson

Ms. Joan Sayer

The Chair

Ms. Carolyn Bennett

1140

The Chair

Ms. Joan Sayer

Ms. Carolyn Bennett

The Chair

Ms. Joan Sayer

The Chair

Ms. Joan Sayer

Mr. Al Gorlick

Ms. Carolyn Bennett

1145

Mr. Jorge Garcia-Orgales

Ms. Carolyn Bennett

The Chair

Mr. Jeannot Castonguay

Ms. Joyce Gordon

Ms. Joan Sayer

1150

Mr. Gord Thow

The Chair

Ms. Joan Sayer

The Chair

Ms. Joan Sayer

The Chair

Mr. Al Gorlick

1155

The Chair

Mr. Al Gorlick

The Chair

Mr. Al Gorlick

The Chair

CANADA

Standing Committee on Health

NUMBER 067

2nd SESSION

37th PARLIAMENT

EVIDENCE

Thursday, October 30, 2003

[Recorded by Electronic Apparatus]

¿ (0905)

[English]

The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Order, please.

Good morning, ladies and gentlemen. It's my pleasure to welcome you to the Toronto hearings of the Standing Committee on Health during its study on prescription drugs.

This morning we have an interesting set of witnesses, and we'll go right to their presentations.

The first organization represented is the Canadian Arthritis Network. Representing that network is Edward Keystone, professor, Department of Medicine, the University of Toronto.

Go ahead, please.

Dr. Edward Keystone (Associate Clinical Director, Canadian Arthritis Network): Thank you, Madam Chair.

Thank you for inviting me to address the Standing Committee on Health on the subject of prescription drugs. I'm an arthritis specialist, the director of the Rebecca Macdonald Centre for Arthritis and Autoimmune Disease. I'm also a professor of medicine at the University of Toronto. I also hold the title of clinical director of the Canadian Arthritis Network, which is one of the networks of centres of excellence supported by Industry Canada to fund scientific research into the causes of arthritis and to support member scientists in bringing new discoveries to market.

Five and a half million Canadians have arthritis and the majority are under 65 years of age. As the population ages, in fact, in the next 20 years, there'll be a 50% increase in the incidence of arthritis in individuals over 65 years of age. The economic burden of this disease is estimated to be $5 million a year. My focus is on helping patients with arthritis, a term that covers more than 115 different chronic and debilitating conditions for which there is no cure. For the majority of patients we can treat the symptoms, but we cannot prevent damage and destruction.

Recently I was involved in the creation of the Canadian Rheumatology Research Consortium, a non-profit corporation whose member rheumatologists, with expertise in clinical research, will conduct clinical trials for new therapies for arthritis.

It takes 7 to 10 years, from the time of discovery, to bring a new drug to market. I believe we have to take a wider look at government policy and at how to facilitate drug development so that people who need treatments have access to them in a timely manner.

Despite the minimum fee of $117,000 provided to evaluate a new drug submission, the Therapeutic Products Directorate at Health Canada remains significantly under-resourced. This results in extremely lengthy and unacceptable delays in obtaining market approval, even when the therapy has already been approved in other countries, such as the United States.

In 2002, for example, it took an average of almost two years for Health Canada to approve new drug submissions, and that means for some treatment the time is even longer. This compared poorly to the average approval time in the United States, which was less than 16 months. The Biologics and Genetic Therapies Directorate took 27 months, on average, for approval.

Canada also takes longer to approve new treatments than European countries such as Sweden and the United Kingdom. This delay causes needless suffering, and irreversible joint damage occurs, creating substantially more disability among Canadian patients, over time, relative to others in industrialized nations.

I urge you to remove the barriers in place that delay review and approval for new drugs. For example, a reasonable option would be for Health Canada to accept the reviews performed and the approvals issued by other countries such as the United States, particularly as it relates to chemistry and manufacturing sections of the new drug submission.

I also urge you to provide the resources necessary to ensure a timely review process and to consider, as an interim measure, the immediate application of temporary resources to address the current backlog of new drug submissions.

Enhancing the process to expedite reviews should not compromise safety. In fact, with regard to safety, we are now in a position, with advancements in information technology, to capture and analyze comprehensive safety data post-marketing approval. Long-term safety surveillance registries would complement the current requirement for spontaneous reporting of serious and unexpected adverse events, and they would better inform medical treatment decisions.

It is equally important that the arthritis patient community be fully engaged and well informed so that they become active participants in their health care decision-making. Greater funding to facilitate the transfer of knowledge regarding their disease condition and therapeutic options would accomplish this goal.

A feature of the Canadian health care system is universal access to a consistent and high standard of care. A mechanism is needed to ensure that people are not denied effective therapies to relieve pain and suffering because they do not have private insurance plans that cover the costs of drugs or they do not qualify for a government-funded drug benefit plan. There must be universal access to approve therapies across all provinces to ensure that physicians can provide the best possible treatments for their patients.

Some people see new drugs as only adding to the cost of treatment. They do not consider the overall impact these medications can have on a patient's quality of life. For example, the discovery of biologic therapies has revolutionized the treatment of one of the most severe forms of arthritis, namely, rheumatoid arthritis. The patients taking these drugs are now able to assume a normal life after years of significant disability. They are able to care for themselves, return to work and, on the whole, lead productive lives, all of which reduces the burden on society.

¿ (0910)

Looking only at the cost of new therapy, without evaluating the substantial benefits, is a short-sighted approach to a complex problem because it deprives people of drugs they desperately need. We need to step back and evaluate the full impact of treatment on the life of the intended patient and on society as a whole.

In summary, I would like to see a streamlined and coherent approach to drug development that facilitates the discovery and testing of new drugs, the review of regulatory submissions, and post-marketing surveillance. The cornerstone of this approach must be to maintain patient safety, while ensuring timely and universal access to the best available treatment. We need a climate that encourages drug development and enhances the availability of new therapy in Canada. This committee, through its recommendations, has the opportunity to have an enormous and positive impact on the day-to-day lives of patients suffering from these serious and crippling disorders.

Thank you very much.

The Chair: Thank you, Dr. Keystone.

Next, from the Canadian Network for Asthma Care, we have the president, Mr. Kenneth R. Chapman.

Mr. Chapman.

Dr. Kenneth Chapman (President, Canadian Network for Asthma Care): Good morning. Thank you for inviting me to join you in these important discussions.

I am a professor of medicine at the University of Toronto and a specialist in respiratory medicine. My particular practice is as director of the Asthma and Airways Centre at the University Health Network's Toronto Western Hospital. I represent the Canadian Network for Asthma Care.

I should say a word or two about who we are. The Canadian Network for Asthma Care is a network or consortium of 25 organizations involved in the care of asthma for Canadians; three types of organizations of health care providers, such as the Canadian Thoracic Society and the Canadian Nurses' Respiratory Society; organizations such as the Lung Association; the lay organizations; and organizations such as the pharmaceutical industry.

I'm sorry. If you're looking for a handout, I'll follow up with a handout. I don't have one for you this morning.

We gather with a focus on helping patients to manage their own diseases more effectively, something that is critical in the field of respiratory diseases and something that we think is somewhat of a model for chronic diseases. We help patients to become more effective partners in their own care. This is critical because the shift in asthma and airway disease management, over the last two decades, has been towards preventive care, keeping people from having sudden respiratory episodes that drive them to hospital emergency departments or into hospital beds. This involves the intelligent use of preventive medications, if you will, the disease-modifying agents or preventive medications that Professor Keystone talked about in dealing with another tremendous inflammatory disease, arthritis.

We have great concerns, however, in our ability to help patients become more effective partners in their own disease management, that is, concerns about their access to drugs and the ancillary services that help them to use those drugs effectively.

You've heard about delays in drug approval. Certainly, that is a concern, but I'd like to take up another theme, which is the delay in getting the drugs into patients' hands once they've been approved by Health Canada.

I know this is a federal hearing. I know that provincial matters are beyond the scope of this hearing, to some extent. But I'd like to point out that once Health Canada has approved drugs for use in Canada, there is a further delay, typically of two years, before provincial formularies cover those drugs for patients who receive drugs either under social assistance or because they're senior citizens. Moreover, the drugs listed on those formularies are highly variable from province to province. It's very difficult, as an expert in the respiratory field, to understand why and how some of those decisions have been made.

I'll point out that in my own province of Ontario, until recently, the drug benefit formulary turned to an American set of asthma management guidelines as its reference. I find this appalling, and not simply on nationalistic grounds.

I might point out to the folks gathered in this room that the Americans are notorious for being well behind in the asthma and respiratory field. It's an unusual area of medicine. I think they're in the forefront in arthritis management, for example, or cardiovascular diseases. But the Americans have, for historical reasons we don't have to get into, lacked some of the drugs and treatment perspectives that Europe, Canada, Australia, and New Zealand have used for at least a decade. In short, they've been slow to use the anti-inflammatory perspective that we have used.

Unfortunately, my own province, covering 40% of Canadians, has turned to an American set of guidelines to help them decide what will be listed on their formulary. It's an appalling state of affairs.

In the neighbouring province of Quebec, just recently, there were some interesting observations--an observation that a somewhat expensive but very potent combination therapy for asthma purposes was being given once only to a relatively large number of patients. This is an interesting and important observation, and certainly would seem to reveal a pattern of inappropriate usage. It is certainly something that deserves a closer look. Again, Dr. Keystone mentioned the importance of post-marketing surveillance studies. The approach of the Quebec formulary was to sharply and harshly limit access to these combination therapies without consultation with the asthma and respiratory experts.

¿ (0915)

I should point out that Quebec is known around the world for pharmacoepidemiologic expertise. I would mention Professor Pierre Ernst and Professor Samy Suissa, experts in looking at pharmacoepidemiological data and understanding what it means.

What it is probably going to mean to the province of Quebec is that patients who need this effective combination therapy for their asthma will not be able to receive it. Meanwhile, those inappropriate prescriptions, if they were inappropriate prescriptions, will simply be replaced by other inappropriate prescriptions. The $100 asthma drug will be replaced by a $200 or 300 antibiotic that was needless, or by two asthma drugs in combination that will cost as much as, or perhaps more than, the combination therapy that the Quebec formulary sought to extinguish.

I don't want to spend too much time on one example, but I'd simply like to point out that the process is what concerns me. If the formularies are to develop sensible guidelines in management, they should work in a transparent fashion, in consultation and collaboration with the expertise that is readily available to them.

Finally, I'd like point out that if patients are to self-manage their diseases with effective access to drugs, they require education. Yet fee schedules and methods of managing disease seldom incorporate funding for patient education. As we shift health care out of hospital beds and hospital environments, as we ask patients to take effective drugs and biologics, we should expect to educate patients so they can do so rationally. We do not do that now.

In some provinces, it would seem that physicians who try to do counselling are in fact discouraged from doing so through fee scheduling mechanisms. There are ancillary services, such as the funding of devices that help patients to inhale medications or spirometry to measure the outcome of treatment, that are not funded in a great many provinces.

I think we need to look at patients becoming more effective partners in their own care, which means providing them with the ancillary services, education, and monitoring that go with the drugs.

I'm sure there are a great many more issues to tackle, but if I were to summarize—and I think I've used more than my five minutes—we do need coverage for all Canadians so they can obtain the drugs that they need to manage their diseases. I think what we need to do is put together some sort of coordination amongst the provinces, so that approved drugs reach all patients who need them in a sensible fashion. I think to do that we need collaboration with all Canadian experts. I hope that in doing so, we'll provide the ancillary services that Canadian patients need.

Thank you.

¿ (0920)

The Chair: Thank you, Dr. Chapman.

Our next witness is from the Anemia Institute for Research and Education, and she is the president and chief executive officer, Durhane Wong-Rieger.

Ms. Durhane Wong-Rieger (President and Chief Executive Officer, Anemia Institute for Research and Education): Thank you very much.

My name is Durhane Wong-Rieger, and I am president and CEO of the Anemia Institute for Research and Education. I am also co-chair of the Canadian Hepatitis C Network, and I also do want to speak a bit more broadly as chair of the Consumer Advocate Network, which is a consortium of not-for-profit health care organizations that are working together around the common issues around health policy.

Let me start from my own experience, and that is the blood tragedies of the 1980s. I would say that the two important lessons we should not forget out of that is, first of all, when patients are denied access to new medications, they inevitably are harmed and, in fact, the health care system incurs more costs. Also, when patients, as I think you've heard already, are not involved in decisions, not only around their own health care but around what health care policy should make available to them, inevitably they are harmed and the health care system incurs more costs.

In the 1990s, when I first became involved with the Canadian Hemophilia Society, and after we became well aware of all the blood tragedies in terms of delayed access to new medications, we had a new drug that was made available to us. It was a synthetic medication that in fact had no blood and was going to be absolutely safe. We thought it was going to be a slam dunk that the governments were going to turn around and fund it. It turned out to cost about twice or three times as much as the current medication. It took us a year and a half of intense lobbying to get the drug made available, and in fact, it was not until the drug companies stepped in and offered a deal that we actually had it available.

Today, hemophiliacs enjoy probably the highest standard of care in the world, and because of the availability of these new medications, they have saved the health care system hundreds of thousands of dollars in terms of not having to go to emergency care, not having to be hospitalized, and in fact, at the end of the day, not needing expensive hip replacement therapies.

Unfortunately, in many other arenas, that lesson has not been learned. I'm involved right now with the Hepatitis C Network. We've been fighting for two years to get access to the latest combination therapy, one that is two years in review and still not licensed, yet it is available in 60 countries around the world.

As president of the Anemia Institute , I have been fighting for what we consider to be one of the miracle drugs of modern medicine, and this is medication that lets patients make their own red blood cells so they don't have to have transfusions. It's available, for instance, to 60% of cancer patients with anemia, and cancer patients use about 25% of the red blood cells in this country. But unfortunately, in this country, because of the way the system is funded, it's available to only about 5% of cancer patients.

Part of it has to do with just the way the whole health care system is funded and the fact that you need to do, unfortunately, intense lobbying to meet the needs of your members.

I do want to speak, maybe a bit more broadly, on some other issues. I think you've heard probably over and over again that the real concern is making sure the right patient gets the right medication at the right time. We believe that if that happens not only are patients well served, but at the end of the day the health care system is better served.

One of the areas I wanted to touch on, and I'm sure you've heard about already, is our concern around the exportation of drugs, whether it be through Internet pharmacy, or, now more boldly, states that are suggesting they're going to come up and buy their drugs wholesale from Canada. It's a little bit ludicrous, given the fact that California is bigger than all of Canada. I'm not sure exactly how they think they're going to make this happen, but it is a serious threat to Canadian patients.

We've been well aware of it, and we have been speaking about it for the last two or three years. We think it is appalling that Health Canada has sat on their hands and taken a very laissez-faire attitude towards this. There needs to be active development of regulations that would forbid the drugs that were designated for Canadian patients to be headed south.

We're also very concerned with what we see right now, drugs that are being purchased now from other countries such as Bulgaria, such as Pakistan, brought to Canada and re-exported to the United States. It's a risk to American patients, certainly, but a greater risk to Canadian patients, especially if any of those drugs were to end up being used for Canadians.

I think the whole matter is connected to the issue of fair pricing for prescription drugs. I'm not here to try to suggest how much drug companies should be making, but we do believe there are some basic principles around fair pricing that have to be taken into consideration.

Prices have to be of fair value, obviously, for the health care system, relative to other therapies. I think you've heard the fact that we need to compare them not only to other drugs but other interventions.

¿ (0925)

We need a fair return to companies so that we can have assurances that they're going to market and support these drugs in Canada. The delays in market access have to do with the fact that it is not cost-effective for companies to market here.

Third, in relation to other countries, obviously we don't want to subsidize the other countries, but also we need fair pricing so that Canada does pay its fair share of research and development and we attract some of those moneys and, in fact, we do not become a magnet for reimportation.

We believe efforts need to be made by the government, working with the Patent Medicine Prices Review Board, to ensure that we have fair pricing for drugs and not necessarily the lowest negotiated price possible. That may be a controversial statement, but I think that when you look at the impact in the overall health care system, it is important.

You've heard people already talk about the excessive time to licensure. We actually are quite pleased that Health Canada is beginning to take this seriously and, in fact, has done some things that we think are going address this issue, but obviously we're still very far behind. But we are very encouraged by what we see happening there.

Excessive time to provincial listing I'm not as hopeful about. Even though there has been the establishment of the common drug review, which was meant to streamline the whole review process and possibly bring drugs to patients in a more timely fashion, at this point we have huge concerns, because we've not seen, first, provinces agree that they will not do their own reviews, even after a common drug review has done the scientific, pharmacoeconomic review and provided a recommendation.

Secondly, as other people have said, we're very concerned because patients are not part of any of these processes. Again, I give some credit to the federal government, to Health Canada, for being much more open to beginning to include patients in their consultations, as part of their advisory committees. We're very concerned that the provinces have been full stop in terms of saying no. And certainly the common drug review has been full stop in terms of saying no, which means that those quality of life issues, those issues that are pertinent to patients in terms of how you evaluate value for money for drugs, are not being taken into consideration. And I do think that even though it's a provincial issue, Health Canada and the federal government do need to take a role in working with their provincial counterparts.

Post-market surveillance. I think I'd be remiss not to mention a bit about it. It's again an area in which we've seen Health Canada make some great steps, and we think the setting up of a directorate on post-market surveillance has been a very positive step. We do believe that phase four clinical trials, maybe similar to what is being done in the United States, need to be considered as part of licensing for some drugs. We do believe that long-term follow-up on adverse events needs to happen in terms of all patients, including things such as patient registries. And certainly the issue around surveillance for drugs that are used, for instance, for pediatric populations is very important.

I'll conclude by saying that overall maybe the thing we need to have most is what other people have already indicated, and that is much more active involvement of patients at all levels of health care decision-making, from the individual patient level right through to the health policy level, where patients need to be engaged as part of expert boards and as part of advisory boards.

Thank you.

¿ (0930)

The Chair: Thank you, Ms. Wong-Rieger.

Next, from the Canadian Diabetes Association, we have Donna Lillie, vice-president, research and professional education; and Ms. Alexis Mantell, senior manager, strategic communications.

Good morning.

Ms. Donna Lillie (Vice-President, Research and Professional Education, Canadian Diabetes Association): Good morning, and thank you for the opportunity to address the members of the Standing Committee on Health on this very important consultation.

It is our intent this morning to perhaps focus on access to therapeutics and on rising costs within the context of the diabetes problem in Canada.

Diabetes is a serious and growing public health issue for Canadians: 1 in 13 Canadians is living with diabetes; and with the very recent drop in the age of risk from 45 to 40, an additional 2.5 million Canadians are now at risk for diabetes. The death rate for persons living with diabetes is twice as high as for persons living without diabetes. Diabetes is a progressive disease, but diabetes complications can be delayed or prevented. Multiple interventions and therapeutic options, however, are essential to manage blood glucose and to prevent or delay the complications of diabetes. Most recent evidence has also pointed to the fact that we can prevent type 2 diabetes and/or delay it in high-risk individuals.

In the spirit of a picture being worth a thousand words, I will refer you to a couple of charts in the presentation.

The first one, and probably one you're familiar with, is based on the work of Dr. Jamie Blanchard from the province of Manitoba, who has done tremendous work in what has been referred to as forecasting the diabetes storm. The chart looks at the Canadian population age distribution, with a base year of 2000 and projected out to 2016. Perhaps as no surprise, we know that baby boomers are aging.

The second chart, however, looks at the issue of diabetes in the year 2000 and the projection for diabetes in 2016, noting the very significant jump as the population ages.

Based on a recent report, the cost of diabetes to Canadians was estimated at $13.2 billion in the year 2002, up significantly from $9 billion in 1998. These costs are forecast to escalate to $15.6 billion by 2010, unless action is taken.

There are obviously a number of reasons that drive these costs—in particular, complications. The next few charts perhaps note the reality of that impact. Again through the work of Dr. Jamie Blanchard, we look at hospitalization among Canadians with diabetes and cardiovascular disease. Using a base year of 1996, we note that over 98,000 individuals were hospitalized, which escalates to 158,000 by the year 2006, and 228,000 plus by 2016.

Again, there is a similar story with lower limb amputations. In the base year of 1996, over 6,000 individuals dealt with lower limb amputations, which escalates by the year 2016 to over 15,000. People with diabetes have a twentyfold increased risk for amputation. One amputation costs $75,000. The rehab costs are not included in that number.

With dialysis, there is a similar story. In the base year of 1996, there were 1,500-plus new persons with diabetes on dialysis, and by 2016 there will be over 3,500.

Living with diabetes 24 hours a day, day in and day out, also comes with a huge personal and financial burden. They are the managers of their diabetes, and they learn to be very active participants in that process. Financially, however, this commitment may cost them anywhere from $5,000 to $15,000 a year to manage their disease. They also live with the knowledge that 80% of people with diabetes will die of cardiovascular disease.

A broader look at the impact on Canadians notes that 77% of new Canadians are from populations at risk for diabetes: South Asians, Asians, and Hispanics. Canadians are aging and obesity rates are rising, both of which pose increased risks for type 2 diabetes. Our first nations, Inuit, and Métis are three times more likely to have diabetes and are diagnosed earlier in life, often with far more dramatic problems.

One in three children born in the year 2000 will be diagnosed with diabetes in their lifetime, and these are not just our high-risk children.

¿ (0935)

In December of this year, the Canadian Diabetes Association will be releasing the most comprehensive evidence-based look at clinical practice guidelines for the country. We had a sneak preview of those in October. Some of the recommendations will include aggressive assessment of risk, aggressive and timely management of blood glucose, aggressive management of blood pressure and lipid levels, and recognition of diabetes as a cardiovascular disease. As diabetes doesn't wait, the immediate use of multiple drug therapies will be recommended to prevent or delay the devastating and costly complications. With more Canadians with, and at risk for, diabetes, there will be more demand on therapeutic interventions.

Our recommendations are as follows:

Canadians living with diabetes should have timely access to medication and supplies that can improve their quality of life and that may decrease the likelihood of future interventions.

New products with proven efficacy should be listed in a timely fashion.

Should a product be discontinued, Canadians dependent on that product should have access either to that treatment or to a viable alternative to it.

The cost of diabetes medication, supplies, and medical devices, as well as the cost of associated diabetes-related complications, should not be a barrier or a burden for Canadians living with diabetes. Today it is.

Government efforts to control drug costs should not be undertaken in ways that restrict patient access to therapeutics that could improve long-term health and quality of life, increase the costs borne by the patient, or restrict physicians' options to prescribe.

A drug and medical devices review process that is timely, transparent, and incorporates a functional post-market surveillance system is essential for the health of all Canadians.

There has never been a more urgent time to act, and we certainly appreciate that you're well aware of that. The Canadian Diabetes Association recommends and supports all efforts to ensure a healthy Canadian population. The seriousness of the diabetes epidemic, however, requires urgent action. Diabetes doesn't wait. Please act now and invest in a healthier future for Canadians both with and at risk for diabetes.

Thank you.

The Chair: Thank you, Ms. Lillie.

Our last speaker is from the Canadian Treatment Action Council, Ms. Louise Binder, the chairperson.

Ms. Louise Binder (Chair, Canadian Treatment Action Council): Good morning. Thank you very much for the opportunity to present to you today on behalf of CTAC.

As you may know, we're a national non-governmental organization providing public policy advice to government and industry regarding systemic barriers to access to treatment for people with HIV and AIDS in Canada. I chair that organization, and I've also been living with HIV for approximately 15 years.

I'm going to touch on a few main barriers at the federal level that were presented to us, with recommendations for action wherever I could find any.

One of the biggest issues coming on the horizon is reimportation and cross-border shopping. While this doesn't yet present a widespread practical barrier to obtaining HIV drugs, we believe it has the potential to be a profound threat.

We've already experienced a problem with one U.S.-based company that has openly refused to launch its HIV drug in Canada until it receives a ruling from the Patented Medicine Prices Review Board that it can sell its drug in Canada at a list price equivalent to the list price in the U.S. and Europe, even though that price will be much higher than the price currently charged for the same class of antiviral drug in Canada. While the company has not explicitly said that it will refuse to launch in Canada if it doesn't get the price it wants, it seems very clear that's its intention. It is more concerned about preserving its large U.S. market than protecting the health of Canadians with HIV. This is obviously unconscionable from a humanitarian perspective; however, this decision is being made for purely business reasons, and there are limited, if any, avenues to challenge it.

In addition, of course, people with HIV are required to use other drugs to prevent and treat opportunistic infections associated with this virus, as well as drugs to counteract the side effects, toxicities, and other adverse health conditions brought about by the antiviral drugs. We're becoming increasingly concerned that these drugs will become in short supply due to limitations to importation into Canada on the part of the U.S. parent. We're also concerned that price increases on currently available drugs and high pricing of new drugs will limit supply in Canada.

Provincial formularies, private plans, federal plans--including the federal non-insured health benefit plan for aboriginal people--and other plans will have to make more choices than they already are, and whatever choices they make will disadvantage those most in need of a broad array of medications, including people with HIV and AIDS. They are also often the people least likely to have the means to pay for such drugs.

This is clearly not an easy issue for the federal government to solve, but that doesn't mean it should not and cannot do anything about it. It can certainly work with its provincial counterparts to close down Internet pharmacies. It can also pass legislation making reimportation of drugs illegal in Canada. It should not, however, in our view, be swayed by calls to dismantle or further hamstring the authority of the Patented Medicine Prices Review Board to control excessive pricing in Canada. Canadians should not be punished for the lack of price controls in any other country.

A second issue, which was mentioned to you this morning and which we strongly support, is the need for reviewing drugs for sale in Canada and then monitoring their safety after approval in a timely fashion. There have been more than 50 reports about the need for timely and transparent access to drugs and the need for post-approval surveillance, and we've been involved with a number of those at CTAC.

You'll see in our documents that we've compared a number of U.S. times to approval versus Canadian times, taking into account gaps in filing times, which are often very short. We want to be really clear that we're not suggesting drugs should not be effectively and safely brought onto the Canadian market, but what we have found is that the time differences are based on a lack of resources in the Canadian system to make these drugs available.

The federal government has acknowledged this in the February budget and has allocated $190 million to ensure a faster drug review process, and there have been multi-stakeholder meetings as a result, held by Health Canada consultants, to discuss solutions. The third of those is taking place this weekend.

We have offered a number of solutions. There are actually 29 recommendations we've been involved in making about pre- and post-approval, and they're in the documents. There is a need for more appropriate resources to review drug submissions, more flexible employment practices, and the implementation of innovative best practices, and we continue to support these solutions.

¿ (0940)

However, I'd like to say that more recently our thinking has evolved to the point where we actually believe the only way those recommendations can be implemented is to remove the pre- and post-approval work from Health Canada and put it into an independent agency. That's what we're recommending to you today. It should be created to manage this portfolio, both pre- and post-approval.

I want to mention just briefly the orderly withdrawal of drugs from the Canadian marketplace, and I mention that in relation to the approval of drugs. We have found that a number of drugs over the last few years, particularly for opportunistic infections, both treatment and prevention, are being withdrawn from the Canadian market by manufacturers because they're not needed by as many people; therefore, they're not as effective for business. The difficulty there is that they are leaving sick people stranded because they don't put into place before the withdrawal a process for either generics to take over or for some other way of getting the drug.

I mention this in the context of the drug review process, because it's our position that Health Canada should ensure that an appropriate and mandatory policy for the orderly withdrawal of drugs from the Canadian market is in place before a company can withdraw them. It should ensure that an appropriate alternate source of the drug is available before such withdrawal. Frankly, our view is that if this policy isn't put in place within a reasonable time voluntarily by the industry, Health Canada should be mandated to impose such a policy as a condition of the approval of drugs from each company.

The fourth area I would like to touch on is the common drug review, and this does fall into the federal domain because it's a process being managed by CCOHTA, which is a federal agency. It's being jointly managed, federally-provincially. It's a common pharmacoeconomic assessment of new drugs, and it's been signed onto by nine of the provinces and the federal government.

Recommendations are made to the provinces based on these pharmacoeconomic data about whether and with what restrictions drugs should be covered for provincial payment. The provinces are free to accept or reject the recommendations in whole or in part. While its purported aim is to provide expeditious and consistent advice in the area of access to treatment, the reality is that its policies and procedures will not achieve this aim. In fact, it's very much hampered by the discretion left to the provinces about whether to accept or not what is recommended to them by the common drug review and CCOHTA.

So from our analysis, the problems with the CDR--and this is also supported by a number of other disability and disease groups, including Durhane's group--can be categorized into seven areas: timeliness, duplication, openness, accessibility, accountability, the need for an objective and informed process, the lack of an appeal process, the need for the best clinical data, and the lack of relevant stakeholders in the process.

I can't really comment on all of these, but for instance, regarding timeliness, there's no fast-tracking system for drugs for life-threatening conditions or for breakthrough drugs in this area, and there's also a lack of adequate staffing to deal with submissions not only from the industry but from drug plans and the common drug review committee itself.

¿ (0945)

The Chair: Ms. Binder, you're well over your time, so maybe the rest of your information can be brought out through the questioning.

Ms. Louise Binder: Yes, there are only a few more comments in this area.

Thank you.

The Chair: Thank you very much.

We'll begin the question and answer period with Mr. Merrifield.

Mr. Rob Merrifield (Yellowhead, Canadian Alliance): Thanks for coming in. It was exhaustive, all of you from different specialties coming in and sharing your thoughts with us. Yet there were some common themes.

First of all, I'd like to know, from each respective field, how many products are in the queue and not approved, and how long they have been there.

Dr. Edward Keystone: In my area, which specializes in biologics or new therapy to treat rheumatoid arthritis, which is the most serious, potentially life-threatening, and destructive disease, there is one agent now that was approved in the U.S. last December. They tell me the file may or may not have been picked up by now. They were filed in Canada around the same time. The approval may be by next December. We're talking about a period of at least a year already.

This is a significant medication. It can also substantially alter and improve the lives of Canadians. That's at least one I know of right now that we're waiting for, and it is a substantial medication.

Mr. Rob Merrifield: That's for arthritis?

Dr. Edward Keystone: That one's for a particular form of arthritis. There may be a number of others, but the ones I'm particularly interested in at this moment are those that will alter the natural course of disease and prevent damage, destruction, and disability.

Mr. Rob Merrifield: And it's been there for a year?

Dr. Edward Keystone: Let's just say it was approved in the U.S. and the studies have been filed—I think about a year ago or so; I can't tell you the exact time. The assumption is it's still going to be close to another year before it's actually approved.

Mr. Rob Merrifield: Would any of the others like to tell me about some of their products?

Ms. Durhane Wong-Rieger: I'd like to speak to the hepatitis C drug we just mentioned. It's been almost two years, and it's actually on fast track. When you talk about a drug that is considered to be a priority drug on fast track being two years in the queue, you have to wonder what's happening.

I think one of the problems is that it's a combination therapy. For some inexplicable reason, Health Canada made the combination a fast track, but they didn't make the monotherapy a fast track. It was like putting a fast train behind a slow train. We couldn't get the combination through until the mono had been approved. Now that they've finally approved the mono, we're asking them, can you not just switch over? They said they can't guarantee it was the same committees that actually reviewed the mono and the combo, which made no sense to us whatsoever. Why would you not simply take that file and give it to them, then, so that they could use the expertise they've already built?

I think partly it's the whole administrative concern around it. This is almost two years for a fast track product.

¿ (0950)

Dr. Kenneth Chapman: Perhaps I could talk about the post-approval availability of drugs. There are five commonly used asthma drugs not readily available to the majority of Canadians through formularies among the various provinces. I'm talking about the majority of the—

Mr. Rob Merrifield: These are already approved but not on the formulary?

Dr. Kenneth Chapman: That's correct. And if I could move to something that is perhaps more closely tied to federal issues, I'll note that more Canadian women will die of COPD or emphysema-like diseases in this country this year than will die of breast cancer, and yet the one medication or biologic that can slow the progression of inherited alpha 1 antitrypsin deficiency emphysema—this is a blood product—is not available to afflicted patients through Canadian Blood Services, unlike hemophilia agents and so on that are already available.

Mr. Rob Merrifield: Are these approved but not available because they're not marketed, or because they're just not on the formulary?

Dr. Kenneth Chapman: They're not on the formulary, in the case of the five anti-asthma drugs I was talking about, and not made available through the Canadian Blood Services like all other biologic products, in the case of the anti-emphysema medication. That is federal, I believe, if we're talking about Canadian Blood Services.

Dr. Edward Keystone: Can I just say that the PPD, when I've spoken to them on several occasions in the last year, have actually pleaded with me: as an investigator, could I please somehow tell the federal government that if they could just get rid of this huge backlog and provide resources, doing so could dramatically change the way things are happening?

Mr. Rob Merrifield: Yes, that was my next line of questioning. If you have these products in the queue, is it that they haven't got to the place where they've picked up the file and started working on it, or is it that when they pick the file up and start working on it they're so slow?

Dr. Edward Keystone: It's both.

Ms. Durhane Wong-Rieger: Part of the problem for us is that in Canada, unlike the U.S., you have no idea where it is, and Health Canada cannot tell you where it is. In the U.S., you can even go to the website and know where it is in the queue. The companies get regular feedback as to where it is in the queue. We have no idea. They tell us it's unavailable to us because of the regulations around access to information, proprietary information. That is one of the recommendations we have consistently made: we have to make the process more transparent. In fact, they can't even tell us if a product has had a licence applied for here, which is ludicrous.

Mr. Rob Merrifield: So in reality,you're not sure when they pick it up.

Ms. Durhane Wong-Rieger: We have no idea. They won't tell us.

Mr. Rob Merrifield: Fair enough.

Dr. Kenneth Chapman: Just to underscore that word “resources”, I have visited the folks in Ottawa. I'm impressed at their goodwill and good science, but also impressed that they are not seeing the same data internationally as I am in the same timely fashion, for lack of resources.

Mr. Rob Merrifield: Okay, fair enough. That's in the scramble to get more products—newer, better products, hopefully—available to Canadians. But one of the focuses of our study is to look at products that are already approved and at what kind of adverse reactions or complications we might be having, from each of your respective areas, and how you are flagging those. Are we tracking them? What kind of problem do you see, from that perspective, in each of your respective...?

Dr. Kenneth Chapman: There are certainly medications that are not being used appropriately—if you will, being used wastefully. We would like to see a more collaborative and consultative process, so that as the medications are being used, we all sit down to look at the data.

Mr. Rob Merrifield: How about adverse reactions?

Dr. Kenneth Chapman: Adverse reactions are orphaned. There is no really good mechanism to encourage their reporting, to encourage the gathering of the data.

Mr. Rob Merrifield: So it's not being reported is what you're saying.

Dr. Kenneth Chapman: I would certainly say.

Dr. Edward Keystone: I think it's critical. This is a very important area. There's a “voluntary” reporting system. If you look at the reporting systems throughout the world for serious and unexpected adverse side effects, it has been suggested in numerous studies that only one in ten of those adverse effects are actually reported.

Therefore, long-term surveillance registries are absolutely critical if we're going to understand the long-term implication to these therapies. That has not been put into place. In the United States there are a number of registries now that have been created, and I think that's a very important aspect for long-term surveillance.

Mr. Rob Merrifield: I would agree with you. That's one of the reasons for our study, but one of the problems we're having is that we don't even know how many people are actually using them. So dramatically, they may be losing their lives because of it. The focus of the attention here this morning was that we need more of them.

I'm not disagreeing with you from that perspective, but I think the other side of the sword that we have to be really careful of is making sure we use the ones we have appropriately. I haven't heard that come through in your testimony.

¿ (0955)

Ms. Louise Binder: Well, I'm certainly very much in favour of that because, of course, with HIV we need the drugs available as quickly as possible because of the life-threatening aspect of the disease. We often are balancing this risk-benefit ratio of getting the drugs out quickly and then how to deal with what we can't learn as a result of the need for them so quickly.

The only legal requirement at the moment for reporting is through the pharmaceutical industry, and they only have a legal requirement for serious adverse events, which is very narrowly defined as life-threatening. It's things that happen to people, things that hospitalize people, and so on. It's clear that we need more mandatory reporting requirements than that.

Mr. Rob Merrifield: And who should do that? Should it be doctors, pharmacists, outpatients, consumers?

Ms. Louise Binder: Oh, I think all of the above. And particularly, we have always advocated for what we call a consumer-driven approach so that even the consumers can directly report where they feel there has been an adverse effect.

Mr. Rob Merrifield: If it's not being done now and consumers have the availability of doing it now, why is it not being done?

Ms. Louise Binder: The consumers don't have the availability; that's really the problem. There are not methods readily available to consumers and known by consumers so that they can, either directly or through any of their health care professionals, ensure that these adverse events are being reported.

Mr. Rob Merrifield: Thank you.

The Chair: Thank you, Mr. Merrifield.

We'll go on to Dr. Bennett.

Ms. Carolyn Bennett (St. Paul's, Lib.): Thank you very much.

If we were to design the best possible agency, post-market surveillance with consumer input, what would it look like? I think one of the things we were talking about yesterday was some concern that this agency would do everything, including buying drugs. I have a view that the regulator has to be a regulator and the people managing the system have to manage the system.

So suppose we were going to have a drug agency, or a health protection agency, whatever you'd call it. What would it look like? I'm struggling this week on how that impacts on getting toward a common formulary, which is quite often an economic thing regarding the decisions as to what we can afford and what we can't afford. Then to come into what goes on a formulary when, actually, whether the product is safe....

I also want to know a little bit about the privacy issues around patient registries. I think you can take identifiers off, and I don't think the current legislation or the previous Privacy Commissioner...knew it was possible to do that.

Then, not just adverse effects, but how do we track the fact that this drug is better than nothing, or nothing might be better than this drug, even though it hasn't had an adverse effect, or that it is isn't so good with grapefruit juice, or it's not...? I mean, there's a whole bunch of things. If we were tracking these things in the long term, we would end up with better treatment for Canadians.

So how would it look if you were going to draw this thing?

Ms. Durhane Wong-Rieger: There is a model for it, you know. Sometimes I go back to saying some of the things that have come out of the blood tragedies are actually some very innovative designs. I mean, with the hemophilia community right now, you do have a patient registry.

The key to it is that it works with the physicians, the association of clinic directors, so that the physicians are very much involved in it. It is a nominal system so that the data is registered at each site, but there's a common repository for it. Each patient is well aware—now this is a fairly deluxe system, it would not work for everybody—each patient, in fact, monitors their utilization. That data is fed directly back into each one of the clinics, and then there's a national registry. They do analysis on the national registry; they monitor and track it.

There are very good models that have already been developed. We have recommended this as a model, for instance, for blood transfusions. Again, to be able to register chronic users and have every single part of it...and you can use it for research, etc.

À (1000)

Ms. Carolyn Bennett: Are you looking at the whole economic burden, too? I ask this because what we keep seeing are these graphs of drug costs going up, but we're not seeing that these arthritis patients are back to work, or that somebody who has a better-controlled diabetes has left hospitalization through all of that. So would you see that CIHI...or how would you put all of these things together?

Ms. Durhane Wong-Rieger: I don't think you need to have it in one repository, though.

Dr. Kenneth Chapman: Absolutely. I'm surprised nobody has used that phrase “silo budgeting”. Certainly that has been one of our problems: drug acquisition costs preoccupy one set of budgeters while hospital costs preoccupy another set of budgeters.

Clearly what has happened in the asthma field is that I don't see patients in hospital beds nearly as often as I did when I was a trainee. Their care has moved to the outpatient setting. They're healthier. They attend work more reliably. But of course their drug care costs have risen. If you look at drug costs, yes, they have risen. Overall cost to the health care system per patient has probably fallen. It would be wonderful to get that together.

Just in terms of the overall system to put together, I would say this meeting is something of a model for the system. That is, you have a consultation among payers, physicians or prescribers, patients, expert groups, and industry. I think we need to recognize that we are all in this together. Forgive me for sounding personal, but most of us in this room are getting older--no, I know, not you--and are going to be using this health care system. Quite frankly, I want it to be cost-effective. I want to get the most out of this system. I'm conscious this morning that we've been somewhat critical, but I do recognize the best efforts of people running formularies.

I've mentioned some bad examples. I'll also describe to you a wonderful example of meeting some folks from a Nova Scotia pharmacare group trying to wrestle with funding of certain respiratory drugs. I was impressed with their diligence and knowledge of the literature. We had a wonderful session that was very productive, that helped me to understand their issues, and I think we arrived at a novel solution to what was going on.

The bottom line is that I think we need a collaborative process that involves all the stakeholders--I hate that word, but every interested party--and I think you've also heard this morning that it should be transparent or open as much as possible. This is how we've arrived at the decision as much as you like it or dislike it; it's open for everybody to see.

Ms. Donna Lillie: If I could comment further as well--

The Chair: If you could be extremely brief, Dr. Bennett's time has gone and I want to fit in other questioners.

Ms. Donna Lillie: I will. Perhaps it's just a comment. I think it's a complex issue, but I think part of the reality is connecting the dots, because I think there's significant work also being done in the country on issues like chronic disease surveillance and statistical analysis that will allow us to match clinical indicators with new therapeutic options and be able to have more comprehensive information.

I think those issues are under way, are under development. I think the reality is exactly that: putting all the pieces together and ensuring there's an integrated communication process among them all.

Dr. Edward Keystone: I have one last part to add to that. I think the key issue is that all of the elements of a database have to include effectiveness, so that you understand optimizing care; safety, as you've already suggested; and pharmacoeconomics. That can be done. It is being done very simply these days in terms of getting back to work and the cost-effectiveness of medication. That's part of the surveillance.

The Chair: Thank you.

Dr. Castonguay.

Mr. Jeannot Castonguay (Madawaska—Restigouche, Lib.): Merci, madame la présidente.

Dr. Chapman, you mentioned that we're all getting old. I have to agree with you, but I don't mind as long as we're getting smarter, and I think we are, as a group.

You mentioned at one point that patients should become partners in their care, that you should manage to educate them, to help them, and I fully agree with this. Also, you mentioned at one point that there might be a problem, as I understood it, with the fee schedule, with the way physicians are paid a fee for service. And sometimes it might be easier to see five patients for five minutes each than to spend twenty-five minutes with one patient. I fully agree with you. I am a physician, so I have been through this before.

Is there anything you are doing in this province to try to improve on this, including the integration of other health care professionals such as pharmacists, or nurses in a team, to take care of these patients? What is your view on where we should go and what we should do about this?

À (1005)

Dr. Kenneth Chapman: I don't want to tangle up provincial concerns and federal concerns too much at this hearing, but I'll point out that I represent the Canadian Network for Asthma Care. I didn't describe to you all that we've done, but our major achievement has been to nurture a program of asthma education as delivered by certified asthma educators.

We're the first country in the world to develop a certification program for asthma educators. If you go to a centre, to a hospital, or clinic where somebody has the initials CAE after their name, that person will be able to educate effectively, and they will be able to teach you important things about self-managing your disease. We think this is a wonderful model for care, and it has been applied in the diabetes field, the arthritis field, and so on.

I think it's important that the federal government as well as provincial governments have a look at how to nurture these initiatives. If we are going to move people out of hospital beds, then we must make the resources available in the community. So, for example, we must find a way to fund educators. Right now, in my province, if my nurse educates for half an hour, I must pay her salary, but I can't bill for her time, and the only way it happens to work, in my particular environment, is by hiding her activities somehow in hospital budgets.

I think the federal government should look at, for example, hospital accreditation programs. If you're a hospital of a certain size, respiratory diseases are common. One mark of excellence for your accreditation is that you have a certified asthma educator or respiratory educator on staff. I would probably say ditto for a diabetes educator, and so on.

These are programs that are developing from the grassroots. The heath care providers see the need for them. I think the federal government could nurture such programs so that we see patient self-managing happening in all of these chronic disease settings in the community.

Mr. Jeannot Castonguay: So far, what kind of answer do you get from your health department here in Ontario? Are they open to this new approach, or do they look at this as another expense? I believe we also have to look within the context. If we keep these patients out of the hospital, it's much cheaper, even if it costs more in the way of drugs than if you have them hospitalized, and with complications and so on. What is the reception of the health department in this province to this approach?

Dr. Kenneth Chapman: The Canadian Network for Asthma Care has attempted to communicate these thoughts to our Ministry of Health and we've found it difficult to communicate, to have access to our Ministry of Health in this regard. I'd love to say I've delivered the message. I haven't.

Ms. Donna Lillie: If I could comment further, in the diabetes world, I think it has become a well-accepted practice that diabetes education is critical to patient management. There are standards for diabetes education across the country that have been accepted internationally as a standard to position diabetes education across the country.

Certainly from a diabetes perspective, the Province of Ontario has been outstanding in positioning support for diabetes education throughout the province, using various different models, both community models and institutionally based models. It is a huge commitment to the reality that a person who lives with a chronic disease is a key active participant in care and management, and often a key decision-maker during those 24 hours, day in and day out.

We have certainly found the Province of Ontario very receptive. Other provinces have similar models, perhaps done a little bit differently, and an acceptance of the fact that it's a key part of patient management of chronic care.

Dr. Edward Keystone: I wonder whether or not one should consider what is being done in other countries. On physician assistance, for example, they actually spend more time with a patient. They have more time. Physicians come in and do what they need to do in a more timely fashion. I must say that I think, overall, patients get much better care when they have a longer-term interaction with someone who has the time to do it at a cheaper cost.

The Chair: Thank you, Mr. Castonguay.

Mr. Barrette.

Mr. Gilbert Barrette (Témiscamingue, Lib.): Thank you very much.

We have a kind of dilemma. I understand your impatience to see new drugs on the market, but at the same time, we've read and you've read, we've heard and you've heard that the efficiency of the drugs is not always there. It costs a lot of money and is not necessarily efficient. There's a kind of dilemma to be sure that the drug on the market will be efficient. That's the first thing.

As for diabetes, it's quite a big problem all across the country, not only in Ontario--I know that in Quebec it's about the same, maybe worse sometimes--and there are the other problems that come with it. What kind of prevention program do you have—I think you talked a little bit about it a while ago—to prevent younger ones from developing the problem?

À (1010)

Ms. Donna Lillie: There certainly are a number of strategies under way. Certainly, we will be working in collaboration generally with Health Canada regarding population health, which is healthy eating and an active lifestyle. Certainly, positioning a healthy Canadian population, in many ways, goes a long way toward potentially decreasing type 2 diabetes over time.

As well, with our new clinical practice guidelines, we are positioning the reality that we do have at-risk populations. It's extremely important that we address those at-risk populations before they are dealing with elevated glucose levels.

For much of that, again certainly the major studies have shown us, with lifestyle intervention and healthy eating in these high-risk populations, we can decrease type 2 diabetes by about 58%. We will not totally get rid of type 2 diabetes, because there are obvious other realities regarding genetics and high-risk populations. It won't do that. At least a 58% reduction, in a great number of people, would be very significant. There are a number of programs that will go out in that regard.

Of particular concern is the increasing incidence of type 2 diabetes in children. Particularly our high-risk children, as young as eight and nine years of age, are being diagnosed with type 2 diabetes and are already showing signs of complications. Strategies are certainly under way to address those issues in the schools and the communities. It's a multi-pronged approach to really get to the bottom of the issue.

Mr. Gilbert Barrette: Thank you.

The Chair: Thank you, Mr. Barrette.

Dr. Edward Keystone: If I could make a comment, I think it's important to appreciate that the patients who are undergoing clinical trials—that is, how they are; how they look; the medications they take; and the other illnesses that they have at the time they undergo clinical trials—are not necessarily the patients to whom these medications go in clinical practice. They are sicker in many ways. They have other medications. They have other co-illnesses along with that illness. That's where the whole area of surveillance is so important. When you ask about effectiveness, there's something called efficacy, which has to do with clinical trial results. Then when you get them on the market, you have to know if they're effective within that population of patients. It's the reason why registries are so important.

We have seven or eight medications that are for rheumatoid arthritis. If you asked me today what the best strategy is to use these medications, we don't have head-to-head comparisons with one versus the other. Companies will never allow us to do that. Therefore, where's the funding to actually find out which is really better in practice? How do we optimize therapy?

The answer is that we don't know once a medication comes out, if you have six or seven, which one is optimal, which one should be first, and which one should be second or third. We don't have that data. I venture to say that, in all of our areas, those kinds of studies aren't done.

The Chair: Thank you.

Mr. Chapman.

Dr. Kenneth Chapman: The prevention triggers a sort of autonomic reflex in a respirologist. For God's sake, continue to increase tobacco taxes. Hold firm against tobacco advertising in this country. There's something of a complacency, perhaps not among legislators but certainly among the public, that we have won or are winning this fight against smoking-related diseases, but it is certainly not the case.

I'm very mindful that in my own field, women are demonstrably much more prone to tobacco-related diseases than men. I believe my cardiovascular colleagues would say that of cardiovascular diseases. I know it is true of lung cancer. More women die of lung cancer than breast cancer in this country right now. It is true of COPD or emphysema, and one of the emerging stories of the next five years will be that those tobacco-related diseases have become a women's health issue in a major way. Yet as I look around my own neighbourhood, and I'm sure as you look around yours, it is young women who are finding smoking fashionable and who are becoming lifelong addicts.

So as you decriminalize certain substance abuse offences, consider criminalizing the sale of tobacco to those under the age of 18, perhaps including some tobacco company executives.

Please, stand firm.

À (1015)

The Chair: Thank you.

Ms. Durhane Wong-Rieger: May I make one quick comment in terms of prevention?

I think we have to consider the examples of diabetes and HIV as areas where the federal government's taking a lead in terms of having strategies has made a tremendous difference in both prevention and treatment. A big area right now that we're fighting for is hepatitis C. It is going to be one of the most costly epidemics in this country.

I think we're very concerned that with the sunsets of the first five-year program there needs to be a concerted strategy that focuses not only on prevention but also on care, treatment, and support. We're very hopeful the federal government will recognize the kind of investments it must make.

The one problem with hepatitis C right now--and I think again where the federal government needs to take a role--is that unlike HIV or unlike the diabetes strategies, they have not been able to engage their provincial counterparts. Unless we have a strategy that integrates the federal efforts and the provincial efforts, everything will fall apart. It is Carolyn's question again--if we learn from what we've done well, we can do these things, and we've seen some tremendous progress in this country. I think, unfortunately, many times we just reinvent the wheel.

The Chair: Thank you very much.

On behalf of the committee, I want to thank all the witnesses for their presentations. It has been most interesting. We have your papers, so we can review anything we might be inclined to forget from what you've said. So thank you very much for your preparation and your presentation. We really appreciate it.

There'll be a 10-minute break now.

À (1016)

À (1032)

The Chair: Good morning, ladies and gentlemen. Welcome to these hearings of the Standing Committee on Health on prescription drugs. We thank you for coming. We'll proceed right away to your presentations.

The first one comes from the Consumers' Association of Canada, delivered by Mr. Mel Fruitman, the president, and Joan Sayer, provincial liaison to the national health council.

Whichever one of you is going to present, please go ahead.

Mr. Mel Fruitman (President, Consumers' Association of Canada): I'll start.

Good morning. Thank you, Madam Chairman and members of the committee, for this opportunity for the Consumers' Association of Canada to appear before the committee on health to present consumer views on your timely study of prescription drugs.

The Consumers' Association of Canada is a 54-year-old, independent, non-profit, volunteer organization, with a national office in Ottawa and provincial and territorial branches. Our mandate is to inform and educate consumers on marketplace issues, to advocate for consumers with government and industry, and to work with government and industry to solve marketplace problems in beneficial ways. We focus our work in the areas of health, food, trade, standards, financial services, and communication services, and we address other marketplace issues as they emerge.

For more than a decade, delegates at our annual general meetings have identified health care issues as priorities to be addressed in the coming year. Unresolved issues regarding drug information, advertising, safety, adverse effects, efficacy, access, and affordability continue to be critical perennial consumer concerns.

It is encouraging that these same issues are the foci of your study on prescription drugs. Although these issues are interwoven, each having an impact on another, we shall address them in sequence.

I'll now turn it over to Joan to go into the details of our brief presentation.

À (1035)

Ms. Joan Sayer (Provincial Liaison to the National Health Council, Consumers Association of Canada): I'd like to add my thanks and appreciation for the opportunity to appear. Je parle en anglais tout le long ce matin.

Each year the percentage of total health expenditures—and I'm talking about rising costs now—for the drug sector continues to increase because in part of increased prescribing of new, more expensive drugs, and each year the consumer is faced with increased direct, out-of-pocket payment for prescription drugs because of a reduction in the range of coverage and increased deductibles in both the public- and employer-sponsored drug benefit plans.

One initiative to introduce competitive prices for new drugs as early as possible under current patent law would be the immediate removal of the procedural impediments that delay the entry of generic drugs to the market, even when the lengthy patent protection of the new drug has ended.

The significant role the Patented Medicine Prices Review Board, PMPRB, has played in monitoring and regulating patented drug prices in Canada is demonstrated in the current media reports that various U.S. states are introducing legislation to permit their public health plans to purchase prescription drugs from Canada because of the startling cost differential for the same product in the two countries. The protection the PMPRB has provided Canadian consumers by controlling patented prescription drug prices over the past 16 years should be recognized and given strong support at this time of pressure from the U.S. pharmaceutical industry.

CAC supports expansion of the mandate of the PMPRB to include the regulation of generic drug prices to give further drug cost reductions for consumers.

The need for a mechanism to control the costs for these products is confirmed by the findings of the recent multiple-source study from the PMPRB. The study compared prices of multiple-source drugs in Canada with prices in nine other industrialized countries and found Canadian prices for generic drugs exceeded the median price among the nine other countries by 21%. In comparison, prices for patented drugs in Canada were on average 8% below median foreign prices in the year 2000 and 5% below in 2001. The reference is quoted there.

I'd like to speak now about my own personal passion, direct-to-consumer advertising. Of course this is all in line with the policy of CAC. Direct-to-consumer advertising, DTCA, continues to be a controversial and conflicting issue, with claims of potential benefits and harm to consumers. CAC has consistently and constantly opposed the introduction of DTCA into Canada. We support the current policy that limits prescription drug advertising to consumers to statement of name, price, and quantity. However, far more stringent and effective mechanisms are needed to control and enforce the restrictions on the content of the ads on billboards and in the media.

CAC regards DTCA as drug promotion to increase use and sale of products, with the consequent increase in costs for the consumer and the health care system. In addition, such promotion encourages the unrealistic expectation of consumers that there is “a pill for every ill” and the consequent overuse and misuse of medications. It's not surprising that we have a problem with antibiotic resistance. Attention and resources are diverted from alternate treatments and needed healthier lifestyle changes.

I walked up the stairs on the subway today. I didn't take the escalator. That's a small change; it helps.

À (1040)

Reports from the U.S., where DTCA has been permitted for the past six years, indicate large sales growth for drugs extensively advertised on television to consumers. Surveys also show that many U.S. consumers, informed and influenced by drug advertisements, ask their physician for the specific advertised drug, and she or he is likely to comply, although he or she would not have prescribed it sometimes. We know the phrase “doctor prescribing fatigue”.

Furthermore, television and print DTCA is expensive, and the drug companies have to recover the billions of dollars they spend on it in the price of the drug product. In summary, there's much evidence that DTCA adds significant costs to the health budgets of the consumer and the system.

Canadian consumers do not need DTCA. What we do need is drug information. We need access to dependable, objective, evidence-based drug information from credible, responsible, impartial sources. DTCA, in any of its modes, does not meet this criterion. Consumers need to know that new drugs may offer the greatest potential benefit, but also the greatest risk, since even less is known about them; however, the uncertain safety record of new medicines is not a deterrent to aggressive marketing that emphasizes benefits and minimizes risks in ads that are directed to both doctors and consumers.

Consumers need to be cautious in accepting a new medication, and they need to take responsibility to ask for evidence that the new drug is better than an older one that has a proven safety record and probably costs less.

There is an apparent need for more expert staff and resources for the drug approval process, not only to expedite the process for approval of new drugs, but also to have the capacity to assess new drug applications stringently and thoroughly enough to justify the safety assurance to the public that the drug will perform as claimed.

Adequate safety testing is the essential component of the approval process to restore consumers' confidence that protection of the public is the overriding principle for the process. More resources are also needed for post-marketing surveillance of drugs, both new and old. Even with scrupulous initial assessment in the approval process, unexpected problems such as the one we heard about this week—Serzone is a good example; that's a recall—arise with broader population use and longer-term use. Such problems are less likely to be identified in the clinical trials that are undertaken to support the application for approval of the drug.

There is a need for Health Canada to further market and promote its 1-800 adverse-drug-reaction or ADR reporting line and to ensure the infrastructure has the capacity to receive and respond to consumer reports and complaints. The system should also commit to public airing of reports on adverse drug reactions to include consumers as well as health professionals.

I'd like to add as a final note that I had the privilege of representing Mel and the Consumers' Association of Canada last weekend at a consultative workshop from Health Canada on look-alike, sound-alike health product names. It's another initiative concerned with the safety of pharmaceuticals and other health products. It's a positive initiative and one we think will add to the safety of the drugs and pharmaceuticals we use that we know are important for us, but certainly come with risks as well as benefits.

Thank you most kindly for your attention to these, our major CAC concerns regarding prescription drugs.

The Chair: Thank you very much.

Our next witnesses are from the Canadian Cystic Fibrosis Foundation: Mr. Gordon Thow, the past president, and Ms. Josée Chiarot, director of the medical/scientific and community programs.

You have the floor.

Mr. Gord Thow (Past President, Canadian Cystic Fibrosis Foundation): Good morning.

As you said, I am the immediate past president of the Canadian Cystic Fibrosis Foundation, which I may refer to as the CCFF.

This of course is a volunteer position. I also have personal connections to this disease, as I have a son and a sister-in-law who both have cystic fibrosis. My son, Simon, is 21 years old and he's currently enrolled at Wilfred Laurier University in his third year. In fact, currently he's probably still in bed at Wilfred Laurier University in Ontario.

CCFF would like to thank the committee for undertaking this important study and for allowing our foundation the opportunity to speak with you.

With me today is Dr. Josée Chiarot, director of medical/scientific and community programs, and Kelly Gorman, who is the manager of social action. Dr. Chiarot and Ms. Gorman will assist in answering any questions you have today.

The Canadian Cystic Fibrosis Foundation is a non-profit charitable organization dedicated to improving the life expectancy and the quality of life of persons with cystic fibrosis. To this end, the foundation funds research towards finding a cure or a control for CF and it supports high-quality CF care. It also promotes public awareness and raises and allocates funds.

We have prepared and submitted a written brief, and I believe each committee member should have a copy of that brief. In the very few minutes we have available, I'd like to comment about two things. First, I'd like to talk about specialized team-based health care for all Canadians with CF, and then I'd like to speak to the topic of the importance of access to life-sustaining medications.

Now, to help the committee members understand what it feels like to have CF, I've handed out a straw to each of you. And you may have seen this before. I would ask you to please take out your straw, put it in your mouth, hold your nose, and try to breathe through the straw for about 30 to 60 seconds. Perhaps you wouldn't mind doing that while I continue with my presentation, assuming you don't pass out.

CF is the most common fatal genetic disease of young Canadians. Approximately 3,400 Canadians have this disease. It affects primarily the lungs and digestive system, but the effects of CF are most devastating in the lungs. That's how people die with cystic fibrosis; the damage is severe, progressive, relentless, and irreversible.

Prescribed drugs and medications, nutritional supplements, and daily physical therapy are essential to the survival of people with cystic fibrosis.

Over the past four decades, with the evolution of specialized care and medications, the median age of survival for Canadians with CF has increased from 4 years of age, back in 1960, to almost 36 years of age today, and that's very important.

When my son Simon was born in 1982, the median age of survival was 22 years of age at that time. Simon is almost 22 years old now. He'll be 22 years old next April, so I think you can see how important it is to us, to my wife and me, and to Simon, that this median age is now almost 36 years of age. Let's hope it keeps moving up.

Canadians with CF are living longer than their counterparts anywhere in the world, and almost 50% of Canadians with CF are over the age of 18 years. So we're making great progress, and one of the reasons for the increase in the median age of survival in this country, we think, is the high-quality team-based care that CF patients receive through CF clinics.

In Canada there are 37 clinics located in hospitals across the country. A cystic fibrosis patient requires multi-disciplinary care because CF is a multi-system, multi-organ disease. Every Canadian CF clinic receives partial financial support from the CCFF.

Now, a typical CF clinic team is comprised of several health care professionals, each of whom has a special area of expertise. The entire team, including the pharmacist, shares in the care of each person with CF. This ensures that all facets of the disease, including the medical, psychological, and personal care needs, are addressed.

Has everybody resumed breathing normally? I think the 60 seconds are up, sorry. I see no straws.

Our brief provides more details on the importance and the value of the CF clinics to improve patient care. However, we'd like to emphasize that we believe this specialized multidisciplinary team approach to CF care and the advances in research and treatment of CF, including prescription drugs, are key components to the increase in the median age of survival and to the increase in the quality of life for Canadians with cystic fibrosis.

À (1045)

Turning now to the matter of access to drugs and medications, I indicated earlier that persons with CF require life-sustaining medications as well as specialized care. We believe that all children and adults with CF should have equitable and full access to life-sustaining drugs.

Fighting CF is hard enough. People with CF should not be plagued with extensive disease-related out-of-pocket expenses. Diagnosis of a life-threatening genetic disease should not translate into an entire lifetime of personal financial hardship as a result of one's illness.

An article in CF News and Views, the official newsletter of the St. Michael's Hospital's adult CF program in Toronto, provided an example of medication expenses. And it showed a yearly cost of $23,495, a very significant amount of money.

Drug coverage for Canadians with CF and pharmacy fees vary substantially from province to province. Because of varying provincial regulations, one's place of residence may significantly affect access to life-sustaining medications, including new treatments such as TOBI or Pulmozyme, which could substantially improve the health and quality of life for some of our adults and children. This does not seem right in the Canada of 2003.

We hear stories of persons with CF not taking prescribed medications or limiting the amount they take because of the costs. And we hear of situations in which a certain drug, although it would be beneficial to the patient with CF, is not prescribed because the patient does not have a means to pay for it and it is not otherwise available to the patient.

Lack of access, or a reduction in access to essential and indeed life-sustaining medications will certainly lead to devastating consequences for Canadians with cystic fibrosis. It could also result in higher costs to the health care system with increased hospitalization for persons with CF.

In conclusion, the foundation believes that all Canadian children and adults with CF should have fair and equitable access to new drugs and therapies, regardless of where they live or how much money they earn. The CCFF encourages federal and provincial governments to work together to establish a collaborative approach to formulary approval and benefits coverage for CF drugs.

Thank you very much.

À (1050)

The Chair: Thank you very much.

We'll move on to the Alliance of Seniors to Protect Canada's Social Programs, and the chairperson is here, Mr. Al Gorlick.

Mr. Gorlick.

Mr. Al Gorlick (Chair, Alliance of Seniors to Protect Canada's Social Programs): Thank you.

By the way, I'd just like to comment that our alliance, and almost every seniors group within our association, agrees totally with the CAC. We're also here to discuss the generics and direct-to-consumer advertising, the two subjects we chose out of the many.

My name is Alexander Gorlick. It says “Al” Gorlick, which is the name I go by. I'm the chair of the Alliance of Seniors to Protect Canada's Social Programs. We are an alliance of over 20 seniors organizations, who have a combined membership of more than 300,000 older adults.

We are addressing the rising costs of medications in Canada and direct-to-consumer advertising of prescription medications. I will deal with the rising cost of medications first.

While we would not care to live in a world without the innovative pharmaceuticals created by the large name brand pharmaceutical industry.... By way, I'm a retired pharmacist, so you can understand that I have some background in both areas of producing pharmaceuticals for us Canadians.

We deplore the excessive cost of prescription medications that all people in Canada must pay, be it directly from our own pockets, or by government by means of our tax dollars, or by third-party insurers through insurance premiums. Eventually the cost always comes back to us.

My personal experience is one small example. My dear wife, who is an Alzheimers patient, requires a medication that costs $90 to $100 per month for 30 pills, amounting to over $1,000 per year. This is for one single medication only.

The cost of medications rose in the past three years at three times the annual rate of inflation; during the period of 1990 to 1999, these costs increased about 87% for the provincial governments alone; and in 1997, these medications alone cost more than what was paid for physicians' services, and have only increased over the intervening years. The cost of all prescription medications exceeded $14 billion in the year 2000. This financial drain on the health care system must be alleviated.

In 1995, Parliament passed into law Bill C-91, which granted 20-year patent protection for pharmaceutical products. That act conforms to a world trade agreement to which Canada is a signatory; however, what is not required by any international trade agreement is the patent medicines notice of compliance, which we will call NOC regulations. These regulations provide for an automatic 24-month injunction against the introduction of comparable and less costly generic products, based on an alleged, but unsubstantiated, patent infraction. This regulation effectively extends the patent protection to 22 years by delaying the marketing approval for lower-cost generic drugs.

Another delaying tactic employed by patent holders is evergreening. This involves the listing of additional patents for a product after the patent for the main ingredient has expired. Again, this delays the public's access to the equivalent lower-cost generic product.

These problem practices were recognized in the United States, and on August 18, 2003, that government changed the regulations and closed similar loopholes in the United States patent laws.

In Canada, the waiting period for generic medications coming on the market is still far too long; therefore, we must stop these abuses of our patent law.

We have in Canada an excellent generic pharmaceutical industry that produces first-class medications. The impediments thrown up by pharmaceutical patent holders prevent legitimate generic equivalents from being produced and being made available to the people of Canada. It is estimated that since the NOC regulations were introduced in 1993, the unnecessary additional cost to Canadian taxpayers has exceeded $1 billion.

À (1055)

The remedy for these practices is obvious, simple, and legal. No trade agreements would be broken, so just remove the NOC regulations. The sooner more generic medications become available to Canadians, the sooner we will begin saving billions of dollars that can then be applied to other aspects of health care. Consider this: generic medications presently account for over 40% of all prescriptions filled in Canada, yet they amount to only 14.4% of the total cost of all prescriptions in Canada.

I bring to your attention one example of the evergreening of the patent of one medication, Losec, or omeprazole. Its original patent expired in 1999, but 10 new patents were added to the original patents register, the latest of which does not expire until 2018. If these are held, it will be 2018. This has added another 19 years to a product that has already enjoyed 20 years of patent protection. This product has yearly sales of about $430 million in Canada and costs patients about $800 a year if the medication is taken once daily. Interestingly, there are equivalents and less costly generic products of this omeprazole on the market in the United States, as well as in Europe. Why not in Canada?

I would now like to talk about direct-to-consumer advertising. This is a method of marketing prescriptions to the general public by pharmaceutical manufacturers. We all recognize that the selling or marketing of products like soap or toothpaste is not to be compared to that of potent prescription medication. In the case of soap or toothpaste, the lack of definite product information is almost always harmless. This is not so when it comes to prescription medication. It is almost impossible in consumer-targeted advertisements—which last about 35 to 40 seconds on radio or television—to inform lay people about the efficacy and appropriate use of a medication versus the risk-benefit consideration of it. When taking a prescribed medication, full disclosure of contraindications, warnings, precautions, drug interactions, and possible adverse effects must be known.

Please picture a recent American magazine ad showing three healthy, good-looking men and women on top of a mountain peak admiring a breathtaking view. The caption below read, “Going the distance”. Now, I ask you, what is being sold—a sport utility vehicle, beer, mountain-climbing gear, or prescription drugs? The answer, of course, as you guessed, is number four. This ad was for Crixivan, a medication to treat HIV infection. What are we doing on top of a mountain looking a scenery and trying to sell a drug?

There are three main objectives for direct-to-consumer advertising: one, to urge consumers to use a different product than what they are presently using; two, to convince people to use a prescription medication for a condition they are not already treating; and three, to provide people with correct and appropriate information about the use of medication. Only number three is valid, and it should come only from health care professionals.

We believe that the main reason pharmaceutical companies advertise in this manner is to promote the use and sale of their product. Such advertising creates more visits by patients to physicians in order to persuade the physician to write a prescription for the advertised product.

I must take a sip.

Á (1100)

The Chair: I urge you to hurry, because you've almost gone double your time.

Mr. Al Gorlick: I'm nearly finished.

To give you some statistics, in 1997 the companies spent $920 million on direct-to-consumer advertising; in 1998, $1.3 billion; in 1999, $1.9 billion, and it's rising. They spent $137 million to advertise an antihistamine, Claritin. They spent $99 million to advertise a product for male-pattern baldness. They spent $93 million to advertise Viagra—we know what that's for.

Why are they spending this money? They're spending it because they know it brings results. Physicians are being pressured inordinately to write these prescriptions for drugs they would not normally use.

Please, we urge you not to change the current food and drug regulations concerning direct-to-consumer advertising.

Thank you very much for this moment.

The Chair: Thank you, Mr. Gorlick.

We now have Mr. Bezo and Mr. Garcia-Orgales from the United Steelworkers of America.

Mr. Rod Bezo (Canadian Coordinator, Steelworkers Organization of Active Retirees, United Steelworkers of America): Thank you.

Mr. Jorge Garcia-Orgales (Researcher, United Steelworkers of America): Thank you, Madam Chairman.

We are very glad to make this presentation to you. We will try to summarize very briefly our presentation. You have copies that you can consult later.

We are here in the name of the steelworkers union. We represent 180,000 workers in Canada and 540,000 workers in the United States. We represent workers in every sector of the economy, from traditional steel and mining to hotels, to restaurants, to nursing homes, to retirement homes. In almost every area of the economy that you mention, we will have members.

We are also here representing SOAR, the Steelworkers Organization of Active Retirees. We have close to 10,000 members in our retirees organization.

Also, some background in our presentation comes from our national health, safety and environment committee.

First, why are we as a union interested in the issue of medication? Our members are the consumers, as everybody knows, and there are two areas in which we particularly get involved in the issue of medication. One is in bargaining.

In Canada and the United States our union bargains health care benefits. It is completely different in Canada, thanks to our public health care system.

Health care packages were always important to our members, but they were not that expensive to the employer; there were minimum things, such as getting a private room in a hospital. In that health care package, medication was always the most important part.

In the United States, on the contrary, we have to negotiate very strongly for the health care of our members. The health care system is private, and we have to fight for the employer to pay for those costs.

Historically, we always see a huge difference in that part of the bargaining, to a point where sometimes one feels even sorry...when you go to the United States, when you drink beer with some friends after a meeting and they tell you how difficult it is for them to go to bargaining.... They tell you not about having to think about wages or benefits, but about having to concentrate on health care costs to get something for their members.

Also, in the United States they need to negotiate health care not only for their members but also for their retirees and their families. Here, we also negotiate health care for our retirees in many cases, but again, the cost is completely different.

I want to mention only one example of those costs. The American Iron and Steel Institute, in the 2001 report, and I'm looking at page 5 of our brief, said that health care insurance in the United States was 18% of the cost to the employer. Eckler Partners Ltd., in their report of the same year on Canada, said that 4% to 6% of a typical payroll cost in Canada was health care. That means a 12% savings on the cost to the employer, thanks to the public health care system.

Again, what we negotiate in Canada in our health care system is mainly drugs. If the cost of drugs keeps increasing in Canada, the cost to our employers will continue to increase, and that will make it more and more difficult for our employers to compete internationally. We know that is happening and we know how our steel industry, particularly, has been affected by global competition. We cannot afford the continuing increase in health care and the continued cost to the employer if we want to compete internationally.

Now, the response of the employer to this situation has been to come to the bargaining table asking for concessions, for reductions in the coverage that they are providing, in the fixed amount of money that they pay, or in some cases just to cut benefits.

Á (1105)

In our statistics we, as steelworkers, know that only 3% of our bargaining ended in labour disruption. That means it's a decent number. We also know that we are a militant union and we know that in December in the United States, if the employers try to cut or to damage the rights of our members, we will respond in ways that we are trying to avoid. And that's the reason why we are talking to you and why we are talking to everybody we can.

I'm sorry to say that we have had in Canada our first strike over health care issues, and that was with Inco last summer, three months ago, in which the employer requested to cut the payment for health care to retirees. Again, that's the reason that SOAR was asked. For us, our members are also the retirees. We are not just talking about the people who are working in a nursing home, in a hotel, or in a plant. Our members are also the people who put their lives into those plants, who contribute to the well-being of that corporation, who contribute to the well-being of that community, and who also work hard to save and prepare themselves for a good life at retirement.

Now, when the employers are coming after the health benefits of the retirees, for us, it's as important as if they are coming for the health care benefits of our members. We will fight for the protection of that. Again, last summer we had our first bad experience in Canada, a strike over health care benefits for the retirees. It is not that uncommon in the United States, but very uncommon, up to now, in Canada.

Now, I won't go through the whole brief, but I want to mention that on page 6 you will have the story of one of our retirees in the United States. I invite you to read that later on, about how the lack of health care benefits is affecting his life and his family. Again, because we need and we treasure good labour relations, and because, again, as a country we need a competitive industry, we need to restrict the price increases of medications and we need to facilitate the integration into the market of generic drugs. We need to facilitate a speedy integration and a speedy entry into the market of generic drugs that, again, could extremely reduce the cost to the employers and could facilitate their relationship with us.

Also, we need the same generic drugs and the reduction of prices for the retirees who do not have health care benefits. When we say we negotiate health care benefits for our retirees, we negotiate, but we don't always get it, like many other things that we negotiate. One-third of our retirees, more or less, have health care benefits, but two-thirds do not. Those people, like any other retirees, need to go and buy medication on their own. We know that more than $1,200 is spent, on average, per family for medication in this country. As we also know that the majority of people over age 65 take at least one medication, we can easily say that the expenditure per family on medication and drugs is a lot higher if you are a retiree.

Á (1110)

The Chair: I'm going to have to ask you to try to close off. You are well over your time.

Mr. Jorge Garcia-Orgales: Okay. I'm sure that if you are interested, you can read the rest of our arguments in our brief. I'll jump to the conclusions.

We want you to support the Romanow report, the part that has to do with drugs and the gradual integration of drugs into the health care system in Canada.

We would like a national drug agency. We are not only interested in the independent control of the new drugs that are entering the market, but we're also interested in the relationship between efficiency and the cost of the drug.

We would like you to continue opposing the direct-to-consumer advertising of drugs. We also would like you to advise the government to review the current education/marketing rules that the pharmaceutical companies are using.

Finally, we also would like you to recommend a review of the Patent Act to facilitate generic drugs.

I want to conclude by saying that we are extremely happy that the Government of Canada is supported in the WTO and is already making noises that we'll pass legislation to relax the Patent Act to allow generic drugs to be exported to developing countries. We think it is an important move. We are asking the Government of Canada to take advantage, as much as possible, of that flexibility because it will open the door for other drugs from other countries and also for other countries.

Thank you very much.

The Chair: Thank you very much, Mr. Garcia-Orgales.

We will move on to the Osteoporosis Society of Canada. Representing that group, we have the president and CEO, Joyce Gordon, and Ms. Gail Lemieux, who is a founding member.

You have the floor.

Á (1115)

Mrs. Joyce Gordon (President and Chief Executive Officer, Osteoporosis Society of Canada): Good morning. Thank you, Madam Chair, and committee members for the opportunity to present to the Standing Committee on Health regarding prescription drugs in Canada and, in particular, how this important issue relates to osteoporosis.

What you have is a presentation, which I am going to give you in summary. There is a written copy of the speech, where I've tried to stay within our five minutes. Gail and I are quite prolific speakers, so this is going to be a challenge, because we're sharing our five-minute slot.

The Osteoporosis Society of Canada was established in 1982. Our mission is to educate, support, and empower individuals in the prevention and treatment of osteoporosis. We do many activities in that regard, but one of the most significant is to develop clinical practice guidelines for health care professionals regarding optimal diagnosis and management of osteoporosis in Canada.

What we see, despite the fact that these guidelines have been distributed far and wide in Canada, is that there are critical gaps in clinical practice and the recommended standards for optimal care. I'd like to take a few minutes to acquaint you with what some of those are.

Osteoporosis is and will be a major, growing public health issue for Canada. There are 1.4 million Canadians who suffer from osteoporosis, one in four women and one in eight men over age 50. By 2026, 21% of the population will be over 65, in effect, doubling the number of people over 65 between now and then. Incidents of osteoporosis are increasing and will rise steeply over the next few decades. In 1993 osteoporosis expenditures were estimated at $1.3 billion annually. This is expected to rise tenfold if we do not take action now.

Osteoporosis is under-diagnosed and, as a result, untreated. As the micro-architectural structure of bones become more fragile with osteoporosis, there is an increased risk of fracture, even after a minor bump or fall. Fractures, most of which occur in the wrist, spine, and hip, can cause enormous pain, suffering, deformity, disability, and death. Once a fracture has occurred, a person is five times more likely to sustain another fracture within a short period of time. In short, fractures beget fractures.

Approximately two-thirds of vertebral or spinal fractures, usually the earliest fractures, are undiagnosed. When an individual is seen for a fracture in the emergency room, only 10% to 15% are referred for assessment of osteoporosis; almost two-thirds do not receive medication treatments for osteoporosis within the first year after fracture; only 4.5% of men receive follow-up. There are critical care gaps in the diagnosis and treatment of osteoporosis.

In most provinces, all of the most effective therapies are listed as second-line agents. Individuals are often relegated to fracture first, before treatment is initiated. Drug plans are increasingly focused on cost containment, rather than ensuring that the best disease prevention and treatment therapies are available to those who depend on the reimbursement plan, particularly seniors and those on low income. Access to drug osteoporosis therapies is unduly restricted in most provinces.

Osteoporosis is a quick and progressive disease once the first fracture occurs. As you will now hear from Gail, the consequences of multiple fractures can be devastating.

Ms. Gail Lemieux (Founding Member, Canadian Osteoporosis Patient Network, Osteoporosis Society of Canada): My name is Gail Lemieux, and I have osteoporosis. My sister has osteoporosis, and my mother died of osteoporosis.

I started fracturing when I was about 40 years old. I also had many vertebral fractures into my fifties. Today, those fractures have compressed further, from 20% to 50%.

I was put on long-term disability from my workplace. I have lost about three inches in height. To me it felt like my vertebrae were ice cubes on a hot July day, just melting away inside of me.

I did not respond to the first osteoporosis drug that I was put on; indeed, I fractured again while I was on it. I was then put on a newer osteoporosis drug, and I was glad there was a choice. I have enjoyed slow bone density improvement ever since.

The other day I went out and bought a new pair of boots--with high heels. It was the first time in 13 years that I have worn high heels. Before, I wouldn't dare wear them because I was afraid I would fracture again just by wearing them.

I am stronger now, and healthier, due to the osteoporosis drugs I am on. Today, we who have osteoporosis know there will be people with osteoporosis who will require long-term care. However, many of us will be able to build enough bone density, given early diagnosis, time, and appropriate osteoporosis drugs, that we probably won't require long-term care. We can get stronger and healthier and live better lives.

We want to be able to look after ourselves and be able to wear high heels if we choose to. We want our bones to get stronger. And we don't want to be like my mom, who never had access to osteoporosis drugs and who endured nearly two decades of long-term care, pain, and disability.

By wearing high heels, I am reclaiming my lost height and I am celebrating the fact that I can wear them now. I am celebrating the fact that osteoporosis drugs have made me stronger, healthier, and more independent than I have been in two decades.

Thank you.

Á (1120)

Ms. Joyce Gordon: Thank you, Gail.

The Osteoporosis Society of Canada believes that individuals should have access to the newest and most effective therapies for the prevention and treatment of osteoporosis, irrespective of their ability to pay. As an aside, we would be very happy to have all brand drugs available, as there are no generics for osteoporosis in the new products. I appreciate the comments, but we have a long way to go to ensure that we have good-quality drugs available.

A more appropriate range of first-line therapeutic options should be made available to meet the diversity of the need within the Canadian population. As you've heard from Gail's story, some drugs are more appropriate for certain individuals than others.

While it is very important that we treat people who have sustained a fracture, we must act to prevent osteoporotic fractures in the first place. Canada is facing an escalating fracture rate, so we must act now. We need women and men to be aware of their risk factors and we need medical professionals to be actively identifying those at high risk of fracture. Intervening early can save pain, disability, hardship, and costs to the health care system.

We urge the Government of Canada to recognize osteoporosis as a significant public health issue, invest funds in the prevention of fractures associated with osteoporosis, and make available a more appropriate range of drug therapies to meet the diverse needs of the Canadian population.

Copies of both Gail's and my speech have been made available to you today. You will have those later, through the clerk. We want to thank you very much for your attention.

The Chair: Thank you very much.

We'll move now to the question and answer period. We have just about 20 minutes left, so I'm going to ask the members to try to stay within the five minutes, and I'll ask the answerers to be aware that each member has five minutes in total for questions and answers.

Mr. Rob Merrifield: I thank you for coming in and sharing with us. I think we've seen a bit of a demonstration of exactly some of the dilemmas we face in Canada here within the panel. You're asking for more drugs, cheaper drugs, so that you can afford some of the best cures in the country or in the world, yet we're looking at making sure evergreening isn't taking place and that the cheapest products for us...you weigh both. You're saying let's have more generics, but perhaps we could retard the development of some of the new drugs, which are the brand names. We've had the testimony of those who were here on the panel just before you actually saying the same thing. This is the dilemma we're in.

Do we have enough of an incentive to give us the appropriate research to be able to have the best products here, yet at the cheapest price? I'm not going to wade into that, because that's really not the focus of this committee and what we're trying to do.

I have a question for Mr. Gorlick.

I'm intrigued. As a senior and a pharmacist, with regard to the adverse reaction to medications--because part of your testimony was that the consumer needs to be more informed--when you practised pharmacy, were you told, as you were marketed to by the pharmaceutical companies, of the adverse effects as well as the benefits on an equal basis?

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Mr. Al Gorlick: You have to understand that the pharmacist does not, in filling prescriptions, traditionally choose the medication. The pharmacist dispenses what the physician orders.

Mr. Rob Merrifield: So did you dispense medication where you were not aware of the negative side effects?

Mr. Al Gorlick: No, we're quite aware of all of them. That's our business, it's our professional capacity to know.

Mr. Rob Merrifield: You got that information from where?

Mr. Al Gorlick: Most of the information I would rely on did not come from pharmaceutical company literature that was provided with the promotional material for the efficacy of the medication. For that we rely mostly on our professional organization, and there is a book that lists every medication in Canada, its indications, its contraindications, its side effects, etc. Most of the professional pharmacists would rely on that as their prime source of information.

Mr. Rob Merrifield: Is the book able to keep up with all the new advancements?

Mr. Al Gorlick: It comes out every year.

Mr. Rob Merrifield: So it keeps up, and that's why you rely on it.

You're out of the industry now, but to your knowledge, is the book accurate, or do you find out more things after a post-surveillance?

Mr. Al Gorlick: That pharmaceutical compendium is probably the main source.

We also rely on continuing education. In other words, the Ontario Pharmacists' Association sends out medical letters regularly to us, which update all the information on a monthly basis.

Mr. Rob Merrifield: In light of that, the question we're wrestling with as a committee is what role the pharmacist should play in this whole area of adverse reaction to medications. If you're knowledgeable and have the book, I would suggest that you're probably more knowledgeable than many physicians. Can you tell me how you see your role fitting into the health care system?

Mr. Al Gorlick: The pharmacist is probably, without question, the first line of information and availability for the patient. We see people more often than anybody else does in a professional way, and most pharmacists are very much aware of some of the side effects and difficulties with medications. There is a system in place for reporting adverse effects.

Mr. Rob Merrifield: Is it being used?

Mr. Al Gorlick: I hope so. Yes, it is.

There's a form that should be filled out. Physicians have to do the same, by the way.

By the way, I say this to you without rancour. The pharmacist is probably the only professional in the world--and I can talk only about Toronto, but in the world also--who does not get a fee for professional advice. We give it all, frankly, gratis. While we do get a professional fee for dispensing, that's for dispensing, and then you have a conversation with the patient about some of the drugs. But when it comes to long-term consultations, this is done pro bono. As a practising pharmacist, I did it constantly and I'm sure they're doing it today.

The Chair: Thank you, Mr. Merrifield.

Monsieur Barrette.

Mr. Gilbert Barrette: Thank you, Madam Chair.

We heard a lot about publicity versus information or promotion. According to you, who should give the information and control the information given?

I think Ms. Sayer talked about that this morning.

Ms. Joan Sayer: Thank you very much for the question.

As I mentioned, we are very interested in seeing that the information is unbiased, complete, and from a very credible source. There are many sources we recognize. Health Canada is a source that we recommend to consumers, their website and information. There's MedWatch; there are a number of places where we advise consumers to go for information, as Al has mentioned. Pharmacists and anyone with a PharmD can really speak directly to the pros and cons of a particular drug. But again, because pharmaceuticals are very particular, we believe that doctors who know their patients--they know their history, they know the other medications they are on--can make very good judgments as to whether or not a particular patient can benefit from a particular drug.

May I add one other thing? One of the CAC leaders in appropriate information was Rose Rubino. Rose set up in Toronto CHIS, which is Consumer Health Information Service, in conjunction with the University of Toronto and the public reference library, so consumers were able to go there for information on health topics, including pharmaceutical. So we would like to see such an agency set up. I know, because I sit on professional practice for the Ontario Pharmacists' Association. They have something called DIRC, the Drug Information and Research Centre. Their pharmacists can phone DIRC, ask for information on particular drugs and the PharmDs who are there are able to look at the recent research and so forth.

That's not also to address the question, as I refer to in the brief, of something that's been on the market for a long time and then we have to recall because finally the evidence is quite obvious that there is a problem with this medication and it has to be recalled.

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Mr. Gilbert Barrette: Thank you.

The Chair: Thank you.

Next, Mr. Robinson.

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

I want to thank all of the witnesses. As I was listening to the witnesses, I thought what an extraordinary range of experience we have on the panel this morning. There are people who have been involved in the front lines from many different perspectives. Mr. Gorlick, who is a pharmacist, now represents seniors. There are family members, consumer advocates, and bargaining agents. It's really quite an extraordinary range. I thank all of the witnesses for their evidence this morning.

On this issue, the dilemma, in a sense, that I'm feeling and that I think some of the witnesses are expressing is really this clash between, on the one hand, a recognition that pharmaceutical drugs are an absolutely critical component of the health care system, and on the other hand, in some cases, huge companies whose sole objective is to maximize global corporate profits. You have this clash.

You see it with direct-to-consumer advertising, which isn't in the best interests of patients. It's there to maximize the number of pills that are sold, quite frankly.

My bias—and it won't surprise you--as a New Democrat and someone whose political hero is Tommy Douglas, is very much to say that we should be integrating pharmaceutical drugs as part of the continuum of the health care system itself. If we cover drugs when a person is in hospital—and many of us have been; I've certainly been in hospital myself, and it's critically important that those drugs be covered in hospital--to me, it's bizarre that the minute you leave the hospital, even if the drugs are necessary, they're no longer covered. I welcome the recommendation that states that this should be a part of that continuum.

I have a couple of questions, because we only have five minutes here. In both the cases of osteoporosis and cystic fibrosis, I take it, there are no generic drugs available at this point to assist those with these particular diseases. Is that correct?

Ms. Joyce Gordon: In osteoporosis or in HRT, there are generics. But as you know, the issue with the women's health study and HRT presents multiple dilemmas for women now. Really, in the other classes they are only brand drugs at this point.

Mr. Svend Robinson: There's nothing available.

Also to clarify--and this is a question I've asked a number of similar groups, including the AIDS advocacy group in Quebec City--do you receive significant funding from the pharmaceutical industry for the work you do in the cystic fibrosis society?

Dr. Josée Chiarot (Director, Medical/Scientific and Community Programs, Canadian Cystic Fibrosis Foundation): We have strict policies on how much we take in from pharmaceutical companies. We raise over $10 million, and less than $100,000 is from pharmaceutical companies.

Those funds are directed to the education of professionals. We have clinics across Canada. We have conferences for the clinic directors to come together and talk about cystic fibrosis clinical care. We only use the funds from pharmaceutical companies for those purposes. They are not flowing into our research programs.

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Mr. Svend Robinson: But you do accept funds from pharmaceutical firms.

Dr. Josée Chiarot: It is less than $100,000 a year out of $10 million.

Mr. Svend Robinson: What about osteoporosis?

Ms. Joyce Gordon: Yes, we do as well, but we have very strict policies and guidelines about their use. It's basically unrestricted in terms of our access as to how we use the funds. When we identify with our partners, it's hands off; we have complete control of the funds. It's really to enable us to do some education.

Mr. Svend Robinson: How much do you receive out of your total budget?

Ms. Joyce Gordon: It's less than 5%

Mr. Svend Robinson: Thanks.

On the issue of direct-to-consumer advertising, I see that later today we're going to be hearing from people who want to take advantage of ads: the newspaper industry and the broadcasters.

I invite any of you to answer. The Consumers' Association spoke to this directly, as did Al Gorlick and a number of others.

What do you say to the newspaper industry and to the broadcasters appearing before us this afternoon? They are saying that this should be thrown wide open. They think it will benefit people in making informed choices about drugs. What's your response to them?

Mr. Mel Fruitman: Facetiously, I would say find another source of revenue.

Mr. Al Gorlick: I have a response as well. Let's face it, you should understand that you're not talking to a communist or a rabid socialist; you're talking to--

Mr. Svend Robinson: There's nothing wrong with socialists.

Voices: Oh, oh!

Mr. Al Gorlick: Hang on. I'm on your mailing list; you have my entire sympathy. I've spoken to union retirees. We have them represented in our organization.

What I'm saying is that I am essentially a capitalist. My friends think that I'm a socialist, because everything has moved so far to the right that those of us who are in the centre are now on the left.

The Chair: That's correct. You must be a Liberal.

Mr. Svend Robinson: Don't go there, Al, don't go there.

Mr. Al Gorlick: I would like to comment, though, that we have to have a conscience about what is good and right and just.

Newspapers are in the business of advertising as well as informing the public, but essentially, if you look at the newspapers, they're loaded with advertising. If you listen to radio programs and television programs, they are loaded with advertising. It's their main source of revenue. When they say they would like to have direct-to-consumer advertising for drugs, they're not really concerned with the benefits to the public, the citizen, or the consumer. They're simply interested in their own viability and profitability. Consequently, I would look with a little bit of skepticism at where they're coming from with respect to the desire to have direct-to-consumer advertising.

Mr. Svend Robinson: Ms. Sayer, did you want to briefly add something?

Ms. Joan Sayer: Yes, please.

I wanted to thank Al for his comments, but I also want to say that Canadians have a different value system. When we talk about DTCA, people say, well, the U.S. has it, it's on the Internet, it's all over. That doesn't make it right. We do not tolerate attack advertising in elections. It doesn't sit well with Canadians.

For many years when my children were young, I sat on the pre-clearance committee for the Advertising Standards Council of Canada for children's ads. We had a different system. We had to approve those ads before they were aired in Canada. Not so in the U.S. People complained about ads in the U.S. The first question they asked was, was it a U.S. ad?

We have a different viewpoint here in Canada. Our made-in-Canada solution is that we have certain controls right now--name, price, quantity--and that's what we want to see in Canada.

The Chair: Thank you, Mr. Robinson.

Ms. Bennett.

Ms. Carolyn Bennett: Maybe I'll just stay on the direct-to-consumer advertising piece. We've heard some concerns at the committee that at the moment we have the rules, but they're not necessarily enforced or they're enforced unevenly. It's virtually a complaint-based system. Then, even if you complain, there doesn't seem to really be the capacity in Health Canada to do very much about it.

Are you saying you were looking for a pre-clearance system, because not opening it up, which is what most of the briefs are saying...? But what we have right now isn't great. If you were writing the recommendations about direct-to-consumer advertising, would you want us to move to more of an audit system, rather than a complaint-based system, or a pre-clearance system? Has anybody done any thinking about that?

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The Chair: Can I just add to your question for another option: would you like us to ban it entirely?

Ms. Joan Sayer: The point of showing the pre-clearance in children's ads was to show the difference between Canada and the U.S. on that particular topic.

No, our point here is that direct-to-consumer advertising does not have a place in Canada.

Ms. Carolyn Bennett: But I can go down on the subway now and there's a big poster there for birth control pills. Who is that for?

The Chair: Well, we talked about it yesterday afternoon. Essentially, we heard that nobody is doing anything about it. It's like a big black hole, and that's why we're discussing it, because of this huge policy hole. That's why I wanted Ms. Sayer to tell us what she wants.

Do you want us to recommend a complete ban on direct-to-consumer advertising?

Ms. Joan Sayer: Yes.

The Chair: Thank you.

Ms. Joan Sayer: There is advertising directed toward doctors, and the Pharmaceutical Advertising Advisory Board, of which I'm a board member, sits on that. There still is difficulty in looking at all material. My own doctor had a series of product monographs in her public washroom. She didn't know about it. There are a couple of other doctors there who share the office with her, and maybe the office manager had something to do with it. There is extensive pressure.

When I was preparing a speech on DTCA to the Canadian pharmacy association a number of years ago, I did some research. Okay, they have it in the U.S. What is the record? I looked at several large pharmaceutical companies. Each one had not complied with certain rules and regulations, and they were fined. There were tremendous fines, in the billions, for inappropriate marketing in the U.S.

One other point I don't know if I've made is that we recognize the value of pharmaceuticals. We also recognize that there is a place for alternative health care, for example, changes in lifestyle. I'm looking at appropriate prescribing of medications.

The Institute for Clinical Evaluative Sciences has done some good work on trial prescriptions. They've done some good work in terms of what is appropriate prescribing, and that's a very important issue in the whole parameter of prescription drugs in Canada.

There is a practice gap, and we have to close that gap.

Mr. Al Gorlick: Just to respond to your question, the fact that the regulations or laws that are in place now are not enforced is no reason to think we should change them. The fact is that if there are laws and regulations in place, we should enforce them. If they're being abused, if they're being neglected, then that's the fault of the enforcers we have, the people who are supposed to be the watchdogs on our behalf.

I think everybody on this panel here--and we've never consulted with each other--everyone who has any feelings in regard to the safe use of medications, is totally and irrevocably against direct-to-consumer advertising.

I think if you ask the question, that's the answer.

Ms. Carolyn Bennett: My question in enforcing, though, is whether we should be asking the people who are coming this afternoon about whether they should have some responsibility, when they're obviously putting...I mean the broadcasters and the newspapers, if they actually are taking money for things that are against the law. Do we need more regulations? How do we do this better, when it's only a complaints-based system now?

A voice: Just enforce the law.

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Mr. Jorge Garcia-Orgales: I think all of us, again without consulting, agree that we would like to ban direct-to-consumer advertising.

But I also want to mention briefly Mr. Robinson's question, what do you say to the people who are coming this afternoon? I think you have an example south of the border, where they have direct-to-consumer advertising. They have all kinds of hope in it, but people are dying in larger and larger numbers compared to Canada. We are second [Inaudible—Editor] in the world, and they are seventh. If you look at child life expectancy, if you look at every area of health care in the United States and in Canada, we are much better off.

So what's the good news about advertising your medication if people are dying? For me, there is no question here. There is no proof that direct-to-consumer advertising is helping in any way to cure or to--

Ms. Carolyn Bennett: Except...and at the WHO there was a very strong interest in tobacco cessation products being allowed to be advertised, in putting big tobacco up against big pharma, instead of big tobacco up against governments that don't spend enough money on this stuff. I think there have been carve-outs, the people who really care about how many people are dying from tobacco and the serious addiction, to let people know that there's help. I remember sitting there in the office in Geneva as they were asking us to do this.

The Chair: Thank you, Dr. Bennett.

Dr. Castonguay.

Mr. Jeannot Castonguay: A short one, Madam Chair.

Merci beaucoup à tout le monde. Thank you for coming. We've heard people also tell us that there should be more advertising, and not only from the industries. And in the name of information, they can make an informed choice, and blah, blah, blah. We have heard that, so we've heard both sides of the equation.

But yesterday someone from the College of Pharmacists said maybe we should not focus as much on the access to all these new drugs, but the first step should be to put more access to educating people on adequate therapies for their problems before we look at medications, that many times we over-medicate people when we could do something else.

I would like your reaction to that: where we should go, what should be the role of the federal government, should we promote this approach, and so on. Your reaction, please.

Ms. Joyce Gordon: I would like to speak to that for a moment.

Part of the charitable sector, the national health charities, has a significant role to play, and it concerns me that over the last six to seven years Health Canada has continued to reduce the funding available to the health charities, which, I think, are most appropriately positioned in terms of credibility, reach, volunteer capacity, and breadth to deliver some of those messages.

I can't speak for some of my other colleagues, but I know around many tables we would support that position of an empowered patient. You heard Gail's story of the difference it makes when you know what the risk-benefits and options are and you can have an intelligent discussion with your physician.

I would urge this group to think about different vehicles for how education is provided and to reconsider the policy decisions that have reduced the infrastructure and support to health charities that need to be looked at as a vehicle to help attain that.

Ms. Joan Sayer: In a different light, in the 1980s I chaired the Scarborough Board of Health, when there was such an organization, pre-SARS and everything else. I know then we were struggling with budgets in terms of health promotion and health protection.

It's not a sexy issue to talk about getting out there to jog, eat properly, and do all the good things, but that's where we need to put resources--to show that there isn't always a pill for every ill, that there is something else you can do. At the same time, I will tell you that I am thankful that there are medications. But as somebody said, everything in moderation.

You can't market it. It shouldn't be marketed like soap or toothpaste. It's very potent, it's very specific, and it will help you. If you look at the broader picture of health care in Canada, it's a part of it.

Our resources are not infinite. I think of it more as a pie, and sometimes the slices get larger or smaller, even with the best of intentions. I've had my flu shot; it's not free. Health Canada is a little bit misleading when they tell you to get your free flu shot. It's not free. We think consumers should know there is a cost to the health care system.

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Mr. Gord Thow: When I was talking about the clinics being multidisciplinary, I think I was talking about the same thing as we are talking about right now. When people come in with a problem they were born with, the answer is not always a pill.

We're trying to help manage the demand by seeing this multidisciplinary team, so you see a dietician, physiotherapist, psychologist, nurse, doctor, and pharmacist. We're trying to combine and make it a more holistic approach, to see if there are solutions other than medication. Having said that, the medications are a critical component to the whole process.

The Chair: Thank you.

I just have a further question, following up on this direct-to-consumer advertising question.

We found out yesterday that the pre-clearance taking place at the PAAB only applies to ads directed at physicians and pharmacists in their professional magazines. There is no pre-clearance of ads for consumers, because essentially the understanding is that we don't allow it. But we've seen it emerge.

I asked the people who were on that PAAB board and who came before us what would be the effect of our banning ads in professional magazines as well. I asked this because we've had some indications that the ads only give half the story, usually the positive half, and not a full explanation of the downside of some of these new products. They told us that those magazines would fold, because they run on the advertising revenue.

So then I asked why; did the doctors and pharmacists, etc., not pay subscription fees for their professional magazines? And they said, “No, they get them for free.”

So we have a situation where even the advertising to professionals is controlled by the pharmaceutical companies, and the people who put out the magazines don't think that professionals would pay subscription fees to have them. So what do you think about that situation?

Ms. Joan Sayer: Could I speak?

I sit on the PAAB board as a consumer representative. Certainly that issue of the funding of the magazine is an interesting issue. I wasn't aware of it, but I know the work of PAAB.

It's complex; it certainly is complex. I believe the ads, as I've seen them in journals, have the product monograph on the back and so much information. Again, there's a great deal of responsibility on the professional physician to ask the questions, to look carefully at the information that is given, as opposed to the one side, which is the ad, and the product monograph on the other side.

I think the U.S. medical journals are much more careful, not only about the articles that are presented but also the material they are carrying. They're recognizing the responsibility they have as journalists to also ensure what is in these.

The Chair: So you're not worried about that kind of advertising because you feel there's sufficient real information?

Ms. Joan Sayer: No, I still worry about it. I still worry about it.

I think what the pharmacists need are other avenues to pursue in getting additional information from an unbiased source, not from the pharmaceutical companies.

The Chair: Al.

Mr. Al Gorlick: I cannot believe a physician or a pharmacist would not subscribe to a magazine that gives him or her professional information, direct information concerning the products they are prescribing. It boggles my mind to think that the medical profession, or any profession, would have to depend upon a business magazine with business advertising to give them the information they require. It should be the responsibility of either the college or the professional association, or somebody.

I'm a retired pharmacist and still belong to the Ontario Pharmacists' Association. They regularly send out what I call medical literature; it's a four-page, or sometimes eight-page, list of every new product that's listed. They give you information and warnings. There's no such thing as promotion. They tell you precisely what the product is for, how it should be used, and when it should be used. They even give you follow-ups months and years later, noting that this product has had this kind of side effect. This information is available.

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The Chair: So the association pays for it through its fees?

Mr. Al Gorlick: That's right.

I pay my fee to the association, then they mail the literature to me free of charge.

This information is here; we don't have to reinvent the wheel.

The Chair: And you get that information as well, as a doctor?

Mr. Al Gorlick: Yes. This is called The Medical Letter, and it has precisely what the dosage is, what the name is, what the generic name is, how it's used, and when it should be used. It's all very clearly outlined, with no advertising.

That's what we should be getting; that's what the doctors should be getting. That's what they should be relying on for their information.

An hon. member: Could we get a copy?

The Chair: Yes, we'd like to have a copy, if we could.

I want to thank you very much for your presentations.

I want to thank my colleagues for their tolerance in letting the chair ask a question at the end and drag us over time.

So thank you for very much for the effort you put into your presentations, for coming out today, and joining us in this discussion. It's been most worthwhile.

The meeting is adjourned.