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37th PARLIAMENT, 2nd SESSION

Standing Committee on Health

EVIDENCE

CONTENTS

Wednesday, October 29, 2003

0910

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

Mr. Paul Drohan (Managing Director, Genzyme Canada Inc.)

0915

The Chair

Mr. Thomas Holloway (President, Pharmex Direct Inc.)

0920

The Chair

Mr. Rob Hamilton (President, Biogen Canada)

0925

0930

0935

The Chair

Mr. Rob Hamilton

The Chair

Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ)

Mr. Paul Drohan

Mr. Rob Hamilton

0940

Mr. Réal Ménard

Mr. Paul Drohan

Mr. Réal Ménard

Mr. Paul Drohan

Mr. Réal Ménard

The Chair

Mr. Rob Hamilton

0945

The Chair

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

Mr. Rob Hamilton

Ms. Carolyn Bennett

Mr. Thomas Holloway

Ms. Carolyn Bennett

0950

Mr. Rob Hamilton

Mr. Thomas Holloway

The Chair

Ms. Carolyn Bennett

The Chair

Ms. Carolyn Bennett

The Chair

Ms. Carolyn Bennett

The Chair

Mr. Gilbert Barrette (Témiscamingue, Lib.)

0955

Mr. Thomas Holloway

Mr. Gilbert Barrette

Mr. Rob Hamilton

Mr. Paul Drohan

The Chair

Mr. Brian Masse (Windsor West, NDP)

Mr. Rob Hamilton

1000

Mr. Paul Drohan

Mr. Brian Masse

Mr. Rob Hamilton

Mr. Brian Masse

The Chair

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

1005

Mr. Rob Hamilton

Mr. Jeannot Castonguay

Mr. Rob Hamilton

Mr. Jeannot Castonguay

The Chair

Ms. Carolyn Bennett

Mr. Paul Drohan

1010

The Chair

Mr. Rob Hamilton

The Chair

Mr. Paul Drohan

The Chair

Mr. Rob Hamilton

The Chair

Mr. Rob Hamilton

Mr. Paul Drohan

The Chair

1035

The Chair

Ms. Lillian Morgenthau (President and Founder, Canada's Association for the Fifty-Plus)

1040

The Chair

Ms. Lillian Morgenthau

The Chair

Ms. Lillian Morgenthau

The Chair

Mr. Len Harrison (Retired Worker Executive, Canadian Auto Workers Union)

1045

1050

The Chair

Ms. Anne Rochon Ford (Coordinator, Women and Health Protection)

1055

1100

The Chair

Ms. Anne Rochon Ford

The Chair

Ms. Anne Rochon Ford

The Chair

Mrs. Gerda Kaegi (President, Canadian Pensioners Concerned Inc.)

1105

The Chair

Mr. Réal Ménard

1110

Mr. Len Harrison

Mr. Réal Ménard

1115

Mme Anne Rochon Ford

Mr. Réal Ménard

Mr. Len Harrison

Mr. Réal Ménard

Ms. Lillian Morgenthau

1120

The Chair

Ms. Lillian Morgenthau

The Chair

Mr. Jeannot Castonguay

1125

Mme Anne Rochon Ford

Mr. Jeannot Castonguay

Mme Anne Rochon Ford

Mr. Jeannot Castonguay

Mr. Len Harrison

The Chair

Mrs. Gerda Kaegi

1130

The Chair

Ms. Lillian Morgenthau

The Chair

Mr. Dean Lindsay (National Coordinator, Retirees, Canadian Auto Workers Union)

The Chair

Mr. Jeannot Castonguay

Ms. Lillian Morgenthau

Mr. Jeannot Castonguay

Ms. Lillian Morgenthau

1135

The Chair

Ms. Carolyn Bennett

Mrs. Gerda Kaegi

Ms. Carolyn Bennett

1140

Mrs. Gerda Kaegi

Ms. Carolyn Bennett

Mrs. Gerda Kaegi

Ms. Carolyn Bennett

Mr. Dean Lindsay

Ms. Carolyn Bennett

Mr. Dean Lindsay

Ms. Carolyn Bennett

Ms. Lillian Morgenthau

Ms. Carolyn Bennett

Ms. Lillian Morgenthau

Ms. Carolyn Bennett

Mrs. Gerda Kaegi

Ms. Carolyn Bennett

Ms. Anne Rochon Ford

The Chair

1145

Mr. Brian Masse

Mrs. Gerda Kaegi

Mr. Brian Masse

Ms. Anne Rochon Ford

Mr. Brian Masse

Ms. Anne Rochon Ford

1150

Mr. Brian Masse

The Chair

Mr. Brian Masse

Mr. Len Harrison

Mr. Dean Lindsay

The Chair

Mr. Gilbert Barrette

1155

Mr. Len Harrison

Mr. Gilbert Barrette

Mrs. Gerda Kaegi

Ms. Anne Rochon Ford

1200

The Chair

Mr. Len Harrison

Ms. Anne Rochon Ford

The Chair

Ms. Anne Rochon Ford

The Chair

Ms. Anne Rochon Ford

The Chair

Ms. Anne Rochon Ford

The Chair

Ms. Anne Rochon Ford

The Chair

Ms. Anne Rochon Ford

The Chair

Ms. Anne Rochon Ford

1205

The Chair

Ms. Anne Rochon Ford

The Chair

Ms. Anne Rochon Ford

The Chair

Mr. Brian Masse

The Chair

CANADA

Standing Committee on Health

NUMBER 065

2nd SESSION

37th PARLIAMENT

EVIDENCE

Wednesday, October 29, 2003

[Recorded by Electronic Apparatus]

¿ (0910)

[English]

The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Good morning, ladies and gentlemen. Welcome to our Toronto hearings on our prescription drug study.

We're a little late starting because we were waiting for the parliamentary secretary, who was to fly in this morning. Considering that there is a bit of fog out there, and he was to land at the island airport, I'm thinking that we probably shouldn't wait any longer, because maybe his flight is delayed.

We'll begin right away with our witnesses. Our first witnesses are from Genzyme Canada Inc.: Mr. Paul Drohan, the managing director, and Mr. Peter Brenders, the health affairs executive.

Gentlemen, whichever one of you is about to begin, you have the floor.

Mr. Paul Drohan (Managing Director, Genzyme Canada Inc.): Thank you.

We tThank you for the opportunity for us to be in front of you today to contribute to your study on prescription drugs.

My name is Paul Drohan. I'm the managing director for Genzyme Canada. To my left is Mr. Brenders, our health affairs executive.

Genzyme Canada is a subsidiary of Genzyme Corporation. We are located in Mississauga, Ontario. We are a biotechnology company whose mission is to develop innovative products for unmet medical needs. We seek frontiers. These are serious diseases where no truly safe and effective treatment exists. I'm pleased to say that our approach has been successful, but not without past and ongoing challenges.

We would like to address a few of your study areas that are of interest to our biotechnology company. Genzyme's focus is to introduce treatment for orphan diseases, but we are challenged by the mechanism of approving new drugs and the mechanism of controlling prices, all in our effort to get consumers and health care professionals access to care.

I will start with a brief history to put our challenges into context.

The origin of our company extends back 20 years to MIT, where some researchers were developing treatments for rare metabolic diseases by looking at complex enzyme therapy. We call them rare diseases because these diseases affect approximately one in 20,000 to one in 200,000 individuals.

It has taken almost two decades and well over $1 billion in order to develop and bring to market effective treatments for Gaucher disease, Fabry disease, and MPS I, which is mucopolysaccharidosis I, or Hurler/Hurler-Scheie disease.

As I mentioned, these diseases are rare and the treatments are complex. We introduced the first generation of enzyme ten years ago. This was a weekly infusion of modified enzyme that was extracted from human placenta. It took 22,000 placenta per year per patient to extract enough enzyme to treat them.

The immediate problems that we faced were twofold. First of all, with being a tissue-drive product, there are inherent risks with that. The Krever inquiry noted that, and asked for recombinant DNA enzymes to be brought to the marketplace. The other is, as you can imagine, that there are quality control issues in trying to purify a product from human placentas, particularly of the number I stated. We needed to find another way.

After years of research and development, we looked at a large-scale production of the common human DNA, a biotechnology product that has come from genetic engineering. This means that we're not producing pills or chemicals, but in fact we are growing proteins in living organisms.

Growing enzymes is slow, risky, and complex. Our challenge was to produce quantities of commercial scale. This meant building a $300 million manufacturing facility with bioreactors in order to produce the product. Each batch is produced in a carefully controlled environment to ensure the results are exact. It typically takes six months from the start of a batch to the finish in order to have the enzyme produced. After this, we're treating patients.

I'm encouraged to say that in the case of Gaucher patients, there are 65 Canadians whose lives are being significantly improved because of the treatment that we have for Gaucher disease.

A point that I would like to reiterate is Genzyme's research and development efforts and manufacturing investment followed our mission to treat rare diseases and save 65 genetic Gaucher patients, some 3,000 patients around the world. We're proud to say that our commitment has recently been recognized by the Spanish Minister of Health, who awarded Genzyme Spain the Spanish Order of Merit in Healthcare.

Our research and development patients are waiting for these therapies, but they face hurdles. You've heard from the staff of Health Canada. Health Canada is not meeting some of its performance targets, and I wanted to give you some specific examples.

¿ (0915)

When trials on our product Cerezyme were filed and fast-tracked, it took from 1993 to 1997 to actually have that product approved. In the case of Fabry disease and Fabrazyme, our hospital-based enzyme therapy for Fabry patients, it has now been 800 days since the dossier was filed.

We believe that Health Canada does an excellent job, but some of their processes are redundant. We say “redundant” because the dossier that we submitted is almost identical in terms of the clinical trial and clinical data presented to both the FDA and the EMEA. However, the organization may vary.

We would like to see the regulatory process form unilateral recognition, in order to look at the safety and efficacy requirements developed by other jurisdictions. We understand that this could save time by removing some of the steps that Health Canada needs to move through.

We would also like to see Canada strengthen its orphan drug disease legislation. The U.S., Europe, Australia, and Singapore all have orphan drug legislation that looks at tax allowances, grants, and other market incentives. Biotechnology will be the home of these products, and Canada can be a global player in this area with support.

In closing, I'd just like to cite the report of the committee on the drug review process of the Science Advisory Board, chaired by Dr. Roberta Bondar. In their report, they noted that supporting orphaned drugs “would confirm in the public mind Health Canada's commitment to the health protection of all Canadians, including those whose needs are sufficiently rare as to escape the normal attention of the market.”

Genzyme's mission is to develop solutions for unmet medical needs. We are driven to help orphan diseases, and we look to this committee to support that cause.

Thank you very much.

The Chair: Thank you, Mr. Drohan.

Our next witness is from Pharmex Direct Incorporated, Mr. Thomas Holloway, who is the president. Mr. Holloway, you have the floor.

Mr. Thomas Holloway (President, Pharmex Direct Inc.): Good morning.

I'm pleased to present to the committee this morning, representing Pharmex Direct, an independent and private Canadian company dedicated to helping build innovative solutions, to help employers manage the rising costs of their health plans, and in particular of their drug benefit plans. As such, we're in a unique position to view the impact of rising drug costs on employers in general and in particular on small and medium-sized enterprises.

Much has been written about the reason for rising drug claim costs, and I don't intend to discuss that here this morning. Much has been written about the impact on the health care system. The majority of what has been written about the impact on the health care system has come from the public sector. However, very little has been talked about or been brought forward expressing the concerns of the private providers of health care.

This morning I'd like to focus on small and medium-sized businesses. In Canada, approximately 20 million Canadians enjoy a private health benefit plan provided by their employer. The employers pay in excess of $12 billion a year in premiums to provide that benefit to their employees. As you may expect, the larger a company is, the greater is its ability to absorb increased costs. While the increase may be substantial in both dollar and percentage terms, the large enterprise has the financial wherewithal to pay the bill. The crunch comes in the small and medium-sized enterprises.

According to Statistics Canada, about five million Canadians are employed in companies with fewer than 100 employees. Another 1.6 million work for companies with between 100 and 500 lives. In total, we have about 6.5 million Canadians working for companies under 500 lives. The distribution of employment within those firms varies greatly. Retailing, for example, represents almost one million people out of those 6.5 million people who work in smaller companies. Retailing is not renowned for being the place to go if you want to make a lot of money; its people often work for minimum wage or slightly above it.

Many companies in this size band of under 500 lives have seen their insurance premiums double in the last three years, with no end in sight. Even if a company is enjoying good claims experience from its own employees, because of the pooled nature of this insurance, meaning that company is in with a lot of other companies, it will still face increases of 15% to 20% a year. Over and above this, many years of cost shifting from provincial governments to the private sector have just exacerbated this problem.

There is very little an employer can do to cope with these increased costs, and the few things that they can do are not particularly pleasant. Here are some of the options that you would have if you were an employer of a small company. You could walk away from the plan entirely and say “We no longer provide a drug benefit plan”. Obviously, this would be disastrous, particularly for low-paid workers and single-parent families who don't have a plan elsewhere. It obviously would be difficult for the company, because drug benefit plans are one of the ways they attract and retain employees.

Another thing a company could do would be to say “Okay, we will grin and bear it, and we will pay the premium”. But in paying that increased premium, they may very well be impairing the future financial health of their corporation.

They could restructure the health plan in a number of ways. They could increase the proportion the employees have to pay themselves. In many plans, the employee pays nothing, or pays 10%—which can go to 20% or 30%. It's beneficial for the company, but all we have done is to move the cost to the employee. Again, these may be lower-paid employees.

Another way you can restructure the health plan is to say “Fine, we only cover these diseases; there are certain diseases we don't cover.” That flies in the face of why an employer would put in a benefit plan in the first place.

Another way is to introduce an annual maximum and say “Fine, we will pay drug claims up to $3,000, $5,000, or $10,000”. At that point, the cost of that employee's drug claims moves from the private sector generally to the public sector, through plans like the Trillium catastrophic plan we have here in Ontario. Again, however, those plans often have deductibles the employee has to pay, and they do not always cover all medications.

¿ (0920)

There is absolutely no doubt that rising health costs, particularly drug costs, are threatening many small businesses. The question is, what can and should be done to protect the small and medium-sized businesses?

There are a couple of things, one being the Romanow commission's talk about a universal plan for catastrophic illness. The opportunity inside the adoption of that plan would be to broaden it to encompass employees of companies that presently have a private plan. The other would be a consideration of a revision to the tax treatment of health plan premiums, to better reflect the value and cost of providing a solid, comprehensive health plan to the employees of companies of this size.

In summary, small and medium-sized businesses are a key driver of the growth in our economy, and rising drug costs are putting them at risk.

Thank you.

The Chair: Thank you, Mr. Holloway.

Our next witnesses are from a company called Biogen Canada. We have here the president, Mr. Rob Hamilton, and the manager of reimbursement and government affairs, Mr. Robert Kulik.

Mr. Hamilton.

Mr. Rob Hamilton (President, Biogen Canada): Thank you, Madam Chair.

We welcome the opportunity to appear before you today and to contribute to your study on prescription drugs.

Biogen is the world's oldest independent biotechnology company and it's a leader in biologics research, development, and manufacturing. A pioneer in leading-edge research in immunology, neurology, and oncology, Biogen brings novel therapies to improve patients' lives around the world through its global marketing capabilities. Our Canadian headquarters is located in Mississauga.

Biogen is a strong supporter of R and D in Canada due to the high calibre of Canadian researchers and academics who are located here. In fact, Biogen was involved just recently in one of the largest dermatology clinical trial efforts in history, and we're quite proud of that.

Biogen Canada commends the Standing Committee on Health for its efforts to examine the critical issues and others that have a significant impact on the health of all Canadians. Ensuring that patients have timely access to important and vital pharmaceuticals is critically important to Biogen Canada, as well as to the patients and caregivers we serve.

Today I'll discuss several key challenges the biopharmaceutical industry is facing as it continues to invest in and do business in Canada. During my discussion I'll try to illustrate some of the critical issues and their impact on the health of Canadians. I'll also attempt to provide some recommendations on how we can improve access to important new biopharmaceuticals in Canada.

The fundamental backbone of the biopharmaceutical industry is the extremely high level of research and development that must take place in order for a new and innovative product to come to market. We've heard today that this process can take up to 15 years and can cost close to $1 billion to be successful. It's essential for the Canadian biopharmaceutical industry and companies like Biogen to bring these new drugs to market in a timely manner, and it's important for two reasons.

First and most important, it's vital to have access to the market for our products in a timely manner, because the health of Canadians depends on it. New and innovative biopharmaceutical products improve the lives of Canadians. In particular, our research into multiple sclerosis has benefited literally thousands of Canadians who are living with this terrible and progressive disease. Our product Avonex is able to prevent patient relapses and is also able to delay the onset of multiple sclerosis. This is a tangible result, how patients' health is improved through investment in research and development and a company's ability to bring its products to market.

Second, as I mentioned earlier, it takes a significant amount of investment in R and D to bring a new product to market. Accessing markets is vital to a company such as Biogen Canada in its attempt to obtain further investments in clinical and product development in Canada. The Canadian affiliate of Biogen has to compete with affiliates in other parts of the world for these investment dollars. Timely access with competitive timeframes for regulatory and reimbursement approvals versus those of other countries is a critical consideration in winning investment for Canadian researchers and clinical institutions. Unfortunately, Canada's track record in approving innovative and important biotechnology products in a timely manner lags behind that of other developed countries. Canada's time to approval is significantly longer than in other jurisdictions, such as the U.S., the European Union, and Australia.

Let me give you an example. In 2002 the biologics and genetics therapies directorate, BGTD, of Health Canada took an average of 31 months from submission to approval for a new product. In the U.S., the Food and Drug Administration's average time from submission to approval was about half that: 15.2 months. One of the key reasons for the approval period in Canada being twice as long as in the U.S. has been the significant increase in the last couple of years in the length of time that a product has to wait in backlog to be reviewed.

We've recently received from Health Canada a new notice of compliance to market a new indication for a product that we've been marketing for several years. We filed a submission with the BGTD in August 2000 to have this new indication included in our product monograph. The file was picked up in March 2002, and we finally received our notice of compliance in August of this year. That's three years to approve a new indication--not a new drug, just a new indication.

¿ (0925)

Canada was the last of the G-7 countries to have this indication approved. This delay prevents patients from benefiting from the R and D that has been invested in our products and it forces Canadians to wait for new, innovative therapies when patients in other countries have had access to them for some time.

The crux of the problem is that Health Canada lacks the resources, both financial and human, to conduct timely reviews. Cost recovery from manufacturers has been introduced in Canada in recent years, but this funding source has not been tied to approval-time performance for Health Canada.

There's also a significant lack of transparency in the process. It's extremely difficult to assess when a submission is in the process, when a reviewer will pick the submission up, and why there are differences in timelines between chemistry, manufacturing, and clinical review.

This issue of transparency was in fact addressed at a multi-stakeholder session in June of this year that examined Canada's regulatory process. At that meeting even Health Canada stated that it is critical that the department master the issues of transparency and openness in order to address concerns of frustration and trust.

All of these issues contribute to the time delay to market that prevents Canadians from benefiting from access to new and important health technologies. It also impacts on our ability to invest in Canada.

There are a number of options for Health Canada and the federal government to improve its regulatory performance and transparency and to ensure timely access to new biopharmaceuticals for Canadians. Health Canada requires additional resources and expertise to improve approval time. Examples of regulatory reform exist in other jurisdictions.

We believe that Health Canada should legislatively tie cost recovery to approval-time performance, similar to the United States and Australia. Moreover, Health Canada's review and approval-time performance should be regularly and formally accountable to Parliament.

In 1992 Congress passed the Prescription Drug User Fee Act, or PDUFA. The PDUFA provides the FDA with increased levels of resources for the review of drug applications and it establishes legislative performance goals for the FDA drug review and approval process. Target dates to complete reviews are established and meeting requests by manufacturers are acted upon within prescribed timeframes.

All of this is possible through increased funding from fees obtained from manufacturers at the time of submission. Unlike the current system in Canada, where a fee is paid at submission and there's no defined link to performance, the PDUFA establishes timelines and performance goals.

Regular meetings with manufacturers and the FDA are also encouraged. Not only does this increase the transparency of the process, but it's also valuable to ensure that submissions are complete. Questions and concerns get addressed prior to filing, thus reducing further delay.

We also believe that if performance targets are not met, a refund of the percentage of fees should be provided back to the manufacturer. This is currently taking place in Australia, where the Therapeutic Goods Administration refunds 25% of the submission fee if performance targets are not met.

Canadian regulators should also share reviews conducted by foreign regulatory bodies. The sharing of these reviews would help reduce the time of approval. International harmonization has allowed companies to submit to regulators simultaneously in different countries. By expanding mutual recognition agreements to include more regions and broader scope, Health Canada will be able to utilize foreign regulatory reviews in place of, not just in addition to, Canadian review.

Health Canada's acceptance of studies, data, reviews, and submission components from other jurisdictions will save both time and money. Sharing of information between regulatory agencies will reduce duplication, take advantage of other countries that have already reviewed the same medications, and help reduce the current backlog of applications at Health Canada.

¿ (0930)

Biogen Canada also recommends that Health Canada should create independent panels of medical experts to advise on drug submissions specific to the disease or condition that the proposed medication would treat. These panels would make recommendations on the approval of submitted products.

In the most recent Speech from the Throne, the federal government announced that it would speed up the regulatory process for drug approvals, in order to ensure that Canadians have faster access to the safe drugs that they need and to create a better climate for research in this country. As options to move forward are being assessed as part of the development of these so-called “SMART regulations”, we encourage the federal government to examine our proposed recommendations and to act upon them.

There are two other areas that I'd briefly like to discuss with you today that have an impact on the health of Canadians.

Patient and disease education is critically important to ensure effective health outcomes. However, there's currently confusion on both the role and scope of drug manufacturers' participation in disease education. Right now, there is a scattered approach to ensuring that patients have effective and timely access to information regarding disease education and the availability of new therapies. Even with the Internet and speaking to their physicians, it can be difficult for patients to obtain information on emerging therapies and new biotechnologies that can increase his or her quality of life and prevent disease or disease progression.

Now, I certainly do understand many of the concerns with the American experience in this area. However, I do believe that biotechnology and pharmaceutical companies can play a valuable role here and be a partner in patient and disease education. Companies have access to vast quantities of data and information that could be useful for patients to help them and their physicians make educated decisions regarding treatment options.

Resources can be made available to patients to learn more about emerging technologies and new treatment. This can lead to richer conversations with their health care providers, better education and treatment decisions in collaboration with their physician, and improved health outcomes. Unbranded education by companies may lead to important health benefits, if patients seek and obtain appropriate care at an earlier stage to help avoid disease and potential complications.

There's already a lot of promotion and advertising taking place in the consumer media in Canada by many companies. This has been occurring for several years and has resulted in confusion and misunderstanding for consumers, patients, and for the industry. The key point here is that what we need is greater clarity on what the role of the biotech and pharmaceutical industry is with respect to patient and disease education. Questions still remain on how we can communicate directly to patients, which agency has regulatory jurisdiction, and how industry can best partner in patient education.

¿ (0935)

The Chair: I'm sorry, Mr. Hamilton, but you're well over your time. I'm afraid I'm going to have to stop you there; otherwise, we won't have enough time for questions and answers.

Mr. Rob Hamilton: Fine. Thank you.

The Chair: I'm sure that members can simply read the last page and a half of your submission.

Thank you very much.

We'll move now to Q and A. We'll begin with Mr. Ménard. Mr. Ménard will be speaking in French.

[Translation]

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

After listening to Paul and Rob during their presentations I was thinking that I would be putting forth a motion once we get back to Ottawa in order to have this committee hold a round table with Health Canada representatives and Industry representatives to discuss drug approval. It does not make any sense to have this problem linger. I was elected in 1993 and in 1995 we had a health sub-committee on the issue of drug approval. Back then Health Canada had agreed to implement a fast track approval process of 180 days. That was 1995, almost ten years ago and you are now telling us that we have delays of 300 days that are not met.

Let’s try to look closer at how to make very specific recommendations. There are a lot of elements brought forth by Mr. Hamilton. First if I understand correctly, the industries before us define themselves as innovative. Your industries are in the business of generic drugs but rather in the business of innovation.

Secondly, we were told that companies pay about $40 million for drug approval. This number is for R-D which contains pharmaceutical research companies. First let’s discuss the joint drug approval process. Would you be in favor of allowing for information exchanges when clinical monographs are submitted in the United States in order not to duplicate the formal approval process of the FDA and have a joint program for meaningful data? I believe this is the first recommendation you would like to see our committee make. Paul or Rob, do I understand you well?

[English]

Mr. Paul Drohan: I think that's an excellent recommendation. As you stated, these are innovative products. This is an issue that needs to be addressed, and it hasn't been addressed since 1995.

When we look to the FDA or other authorities, I think that one of the issues is not only the product monograph, but also when they look at the clinical trial evidence, and chemistry and manufacturing. Those are two other areas where, potentially, the expert review committees that are in place, particularly in the FDA, could be used as a source of information for Health Canada to expedite the process.

Thank you very much for the motion that you're going to table when you go back. We'd be fully involved in participating in such a meeting with Health Canada.

Mr. Rob Hamilton: Right. I would concur with that. I think we are an innovative industry. We have a tremendous future, and a tremendous future in Canada. We're also, I think, pioneering for many Canadian-based pharmaceutical companies to establish themselves here in Canada.

I think that in the coming years there's even going to be an increased workload on Health Canada as some of these products that have been developed in Canada start to come to Health Canada. I think it's critically important that they find ways to speed up their approval times, given that they're going to have an increased number of products submitted in the next few years.

I would support that idea of a motion, looking at joint reviews or reviews where we take partnership with other regulatory agencies, not necessarily the FDA, but the EMEA or Australia. I think that could really help to reduce redundancy and therefore time and cost.

¿ (0940)

[Translation]

Mr. Réal Ménard: OK. Here is my second question. Some of the earlier people we have heard were from Health Canada. I do not remember the average they had talked about. Maybe the researcher has the figure I am looking for but I think it was 200 days and less in order to complete the drug approval process in Canada. We have statistics for such figures anyhow. What do you see as slowing down the process? Are we lacking examiners? We were shown a slide with 30 or so comprehensive files lined up on the shelves. Is the approval process to obtain a notice of compliance too regulated, too bureaucratic? Are you asked to submit irrelevant information or is it rather that we need to hire more examiners? We need the notice of compliance of course but what do you think are the flaws of the approval process?

[English]

Mr. Paul Drohan: I think that resources are an issue. When you look south of the border to the FDA, they have ten times the resources that Health Canada has. When they put into place their fee structure for reviewing dossiers that were submitted, along with that came resources. I think that members of Health Canada have noted it in the presentation to the committee.

I think the issue also is internally the number of people who are available and the expertise that's available to actually review this information. BGTD, the Biologics and Genetic Therapies Directorate, is an organization staffed by individuals with a science background. Unfortunately, with so much data out in the scientific community, it's tough to be an expert in all areas.

I think that the ability to have external committees, which is part of the therapeutic access strategy, or external expert advisory groups they could go to, in order to resolve that issue of information and the expertise that is required, would be one step in the right direction.

I think it's duly noted that the resource issue is something Health Canada deals with, BGTD deals with, and TPD deals with as well.

[Translation]

Mr. Réal Ménard: I would like to understand better. This will be my final question. Health Canada hires full time employees, FTEs as the Treasury Board says. These people must specialize themselves in various fields. You say it is difficult to ask them to be experts in plasma, penicillin and all sorts of products that Health Canada might need to evaluate. You would like to see contractors hired to help them with the drug approval process. Is that what you are saying?

[English]

Mr. Paul Drohan: I think one option that would be open to us is to have people available, either on contract or experts in this area, similar to what the FDA does with their expert advisory committee.

Physicians who research in this area spend their lives developing and understanding the disease. To ask someone at Health Canada to have that expertise, when they're dealing with a dossier for months, I don't think is fair to them. Yes, we would encourage that there would be an external group that could be contracted.

[Translation]

Mr. Réal Ménard: You know that Members of Parliaments are asked sometimes to be knowledgeable in many areas even if they are not necessarily specialists. But that is another issue of course.

The Chair: Thank you Mr. Ménard.

[English]

Mr. Rob Hamilton: I might just like to concur that the external experts perhaps have a better view about how the therapy will actually be used in the real-world setting and can make recommendations on the importance of the therapy to Health Canada. I think that's an important consideration that non-experts can't always grasp.

¿ (0945)

The Chair: Thank you, Mr. Ménard.

Ms. Bennett.

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

Obviously, we're used to the United States having ten times greater whatever, but really what you're saying to me is the FDA has ten times the resources to deal with the same number of drugs. All the drugs come before Health Canada and they come before the FDA, and they have ten times the money to do that. Some people have some concerns. Certainly some citizens' groups think that some things go through...that it's maybe not as transparent or rigorous.

My understanding is that of the 57 drugs that were approved last year.... We approve all of them anyway, right? We're not actually finding things that were missed by the FDA or missed internationally. We go through this process, and then they all get ticked at the end anyway.

I was interested in the process that one of my former constituents, Alex Patakos, worked on with the FDA, where citizen groups, the patients, and the experts were also watching what was happening globally and were involved in a process to see whether the international evidence was sufficient to get this more than fast-tracked, to get it approved and out into post-market surveillance, or whether it should go through some sort of regular channel. There was a transparency about red light, green light, amber light in that. Is that something that would make sense to you?

I know there's this ongoing harmonization that's happening anyway, because all the countries.... The EU is already on a common formulary. Romanow suggested a drug agency. Would you be in favour of a drug agency that also had the capacity to red light, green light, amber light things, involving citizens and focusing also on post-market surveillance?

Mr. Rob Hamilton: I think, certainly, Biogen Canada would be.

Part of the expert advisory committee process in the U.S. is that the public is able to attend those meetings, to see the so-called experts, the therapeutic area specialists, make recommendations. They're able to make presentations to the FDA at those meetings as well, and it does really increase openness and the transparency of the process. I don't believe that's the case with our current system in Canada.

Ms. Carolyn Bennett: I wanted to know, Mr. Holloway, what you thought that appropriate tax treatment should be, if there were a recommendation on tax treatment for small and medium-sized business to be able to better afford a drug plan for their employees.

Mr. Thomas Holloway: There are two components. The first is the negative component. Back in the early 1990s, when Mr. Martin was the finance minister and was looking to balance the budgets, one of the conversations that was held was that health insurance premiums not be tax deductible from the point of view of the employer and that they become taxable in the hands of the employee. Hopefully we have got past that, so I'd like to put that one to rest and hope it never raises its head again.

The other side of it would be to look at some kind of correlation between the amount of money an employer has to pay to provide a comprehensive health benefit plan and the impact having that has on profit. So if a company is very profitable, it is obviously in a better position to provide that benefit plan. If providing that benefit plan impairs the profitability, and by extension, the long-term financial stability of the company, then there could be some form of incremental tax relief over and above what exists today.

Ms. Carolyn Bennett: Maybe, Mr. Hamilton, you could go over a bit of your paper that you weren't able to say.

Could you give us the Coles notes on Internet pharmacies?

¿ (0950)

Mr. Rob Hamilton: Sure.

Obviously there has been a proliferation of cross-border trade in Internet pharmacy prescription sales to the U.S. I think that has garnered a lot of attention recently, but it also raises significant concerns for the health of Canadians and for the access of Canadians to these drugs--and eventually, I think, to the pricing of drugs in Canada as well.

Internet pharmacies bypass regular channels of patient safeguards, like face-to-face consultation with pharmacists, physicians, and other health care providers, and there's a concern that this contributes to the shortage of pharmacists in some areas of Canada, like Manitoba. I think it undermines the regulatory regimes of both Canada and the U.S. There are no controls or regulations. Clearly the laws of another country are being compromised, intellectual property rights are being violated, and we could also well be in violation of trade rules.

I think our position on Internet pharmacy and cross-border trade in the so-called grey market of pharmaceuticals is that the federal government needs to take a position on it. To date, we haven't seen that, and I think that's what our request today before the standing committee would be, that the federal government should take a position on this bilateral trade issue.

Mr. Thomas Holloway: Just to take that and tie that to the small business issue, pharmacies are small businesses. In a lot of cases, they are independent pharmacies. Half of the medication that a pharmacy will dispense is paid for by the province, whichever province that happens to be. Provinces are notoriously slow to increase what they pay the pharmacies, based on the increasing prices from the pharmaceutical companies.

Pharmaceutical companies quite rightly are moving prices to close the gap between Canada and the U.S. That gap right now is being paid for by the pharmacies because the provincial plans are not moving in behind to pick up the slack. What that does is, again, squeeze the profit margin of that independent pharmacy, and in turn, over the long haul, jeopardize the number of pharmacies that we may have available for Canadians.

The Chair: Thank you, Ms. Bennett.

Ms. Carolyn Bennett: Maybe it's not a part for the witnesses, but are we hearing anybody next week in terms of Internet pharmacies when we get back to Ottawa? I don't think we knew this was going to be quite as--

The Chair: We had a number of witnesses in Winnipeg; therefore the testimony will be available. Perhaps you can get the transcript and see the various views.

I can say that one of the reasons everyone is having trouble with this is because even within the province of Manitoba, which is the most affected at the current time, various ministries in that government and various sectors of the economy that are impacted have opposing views. So they are trying to work out a position in Manitoba, trying to bring some of these people together to figure something out, and it's not proving to be easy.

We had the minister. You would be interested in the transcript, Ms. Bennett.

Ms. Carolyn Bennett: I certainly heard the Manitoba cacophony. I'm saying that Manitoba is so outlying compared to what's best for the rest of Canada. I think there are other provinces that would like to comment on what's happening in Manitoba.

The Chair: Tomorrow afternoon we're having someone on this subject.

Ms. Carolyn Bennett: Okay, because I would hope that by next week we would be able to say something about this.

The Chair: Yes. We hope to as well.

Monsieur Barrette.

[Translation]

Mr. Gilbert Barrette (Témiscamingue, Lib.): Hello and thank you.

One of my questions today is precisely related to internet sales. I was reading this morning an article, in the Globe and Mail I think, about security issues with electronic commerce on the internet. What would you recommend to better handle security issues with sales over the internet? Buying over the internet is like buying something in a convenience store. Should professional bodies guard the population? What would be your recommendation?

¿ (0955)

[English]

Mr. Thomas Holloway: That is a very difficult question. I think the short answer is to encourage the FDA to enforce the laws that are presently in place in the United States. The FDA is very much aware of what is going over the border. They know that it's going over the border, and very openly, they have turned a blind eye to it. If they were to enact or to enforce the laws that are in place today, they would stop it relatively quickly.

The big issue is that the majority of regular medications that are dispensed in this country are in fact produced in the United States. We bring them in, we repackage them, and we sell them. When they go back over the border, they're being reimported into the United States, and that is expressly forbidden under U.S. federal law. That is what FDA is turning a blind eye to. So that would be one of the key things.

They know that if Minnedosa, Manitoba, is shipping 10,000 packages a day, we're not sending maple syrup.

[Translation]

Mr. Gilbert Barrette: My next question concerns the universal plan. This is certainly a recurrent issue among all the things we have heard here. In the Maritimes on Monday we discussed again the issue of the common plan and the universal plan. What would be the Federal Government’s role given the autonomy and the protection of provincial jurisdiction with respect to financial responsibility?

[English]

Mr. Rob Hamilton: I think it's another difficult question that probably gets at the Canada Health Act and the areas of jurisdiction for the federal government and for the provinces, having the responsibility for health care in their jurisdictions.

Certainly a universal plan would give access to all Canadians and would avoid some of the inequities that we see from different areas of the country and different socio-economic disparities among Canadians, but I also think the present system, multi-level in nature, with the federal government approving the drugs based on their efficacy and tolerability is workable, whereas the provinces and private insurers picking up the cost and reimbursing the drugs is a good system of checks and balances that while not perfect seems to work to ensure that almost all Canadians have access to basic pharmaceuticals.

I don't know. Moving off the current system I think would be risky and fraught with difficulty as we transition to that.

Mr. Paul Drohan: If I can just reiterate what Mr. Hamilton stated, the process that we have is workable. We just need to do a better job at its functioning and then allow the provinces that jurisdiction. Let's take what we have and try to improve upon it, rather than create something that may or may not improve the process that we already have.

The Chair: Thank you, Mr. Barrette.

Mr. Masse.

Mr. Brian Masse (Windsor West, NDP): Thank you, Madam Chair. Most of my questions have already been asked, but I do have one I would like to get to.

I note what was said in the presentation about the timely manner of getting drugs to the market, and there has been a lot of discussion about how to go about doing that.

In the industry committee, we've been studying the notice of compliance and the developing relationship between generics and pharmaceuticals that are entering new products and how that relates to research and development.

Canada lags behind many nations in research and development. How does this play into it in terms of making decisions about R and D in Canada, in terms of the timely manner? Can you give me some type of concept to compare the two situations so that I can get an idea about, if we improve this timely manner, what we should expect to see for R and D in this country?

Mr. Rob Hamilton: In my address I mentioned that we have to compete with other Biogen affiliates around the world to get research and development located in Canada.

I think it's a factor of three things. One is the quality of the research we have in Canada; really, it's unparalleled around the world. We have tremendous specialists, tremendous physicians, tremendous academic researchers. So the quality of the research is really not an issue. It comes down also to the cost involved, and to the timeliness.

The cost to conduct research in Canada is not out of line with that in other jurisdictions around the world. It's really the timeliness of approval following that research that is the major sticking point. Decision-makers within global companies look to Canada, and if we can't get products approved in a timely fashion, that means often the research goes to other affiliates and other jurisdictions as a result. It really is hamstringing us.

À (1000)

Mr. Paul Drohan: I think Canada is in an enviable position when you look around the world, and particularly when you look to the U.S. Our research and the way medicine is practised in this country are regionalized. What that allows for is large pools of patients who would be eligible for clinical trials, and the ability within the health care system for physicians to actually work together—which is quite a nice position for Canadians and Canadian patients who can benefit from the research to be in.

The quality of the research is definitely a factor. After approval, it's a question of time to reimbursement, of time to commercialization. As Mr. Hamilton stated very clearly, we compete with other subsidiaries around the world.

I think the Canadian Customs and Revenue Agency has done a good job in putting forth the SR and ED—scientific research and experimental development—tax credits. We need to do a better job to get the word out on this, because I think it encourages a situation where, both on the exchange rate as well as in their ability to use tax credits, companies can do their research cheaper in Canada. But the quality of the research is similar to that of the U.S. and other western countries. In the end, when companies make those decisions, it's not just the approval time they look at, but the access to reimbursement that's available to patients and hence to the organization.

Mr. Brian Masse: Let me follow up, Madam Chair, with one other quick question.

I live on the border between Windsor and Detroit, so we receive so-called education about drugs. It's a very strategic marketing strategy. If we're ever to close that gap, what types of greater freedoms are you looking for in your education or marketing programs?

The subject gives me a little bit of uneasiness, because I've talked to a lot of physicians and pharmacists who are increasingly getting more people who are self-prescribing. It's not only causing relationship strains between doctor and patient; it's also leading to other issues about confidence in physicians, because people can't get the product they want to self-prescribe.

Where do you see us going on that? If we were able to narrow this down to get the drugs sooner on the market than anywhere, what are you looking for in terms of more freedoms or liberties to educate our market?

Mr. Rob Hamilton: I think it's important that you look at the type of drugs we and Genzyme manufacture and to whom they are targeted. The diseases our drugs treat are often orphan diseases; they're smaller-sized diseases. For instance, there are only about 13,000 patients in Canada who are treated for multiple sclerosis every year.

We're not really talking, when it comes to direct-to-patient education, about wide-scale promotion. Instead it's more about patient education after the prescription and helping them understand how to use the drug optimally.

I think it's a reasonable compromise approach to take, compared with the direct-to-consumer promotion approach in the U.S., to look more at a direct-to-patient disease education approach in Canada.

Mr. Brian Masse: Thank you, Madam Chair.

The Chair: Thank you, Mr. Masse.

Mr. Castonguay.

[Translation]

Mr. Jeannot Castonguay (Madawaska—Restigouche, Lib.): Thank you, Madam Chair.

Ma question is for Mr. Hamilton. In your brief you state that:

Patient and disease education is critically important to ensure effective health outcomes. […] Right now, there is scattered approach to ensuring that patients have effective and timely access to information regarding disease education and the availability of new therapies. Even with the internet and speaking with their physician, it can still be difficult for a patient to obtain information on emerging therapies and new therapies that can increase his or her quality of life and prevent disease or disease progression.

Further you add:

Unbranded education by companies may lead to important health benefits if patients seek and obtain appropriate care at an earlier stage to help avoid disease and potential complications.

Can you explain to me how this will enable faster access to health care service if there are no more doctors or health professionals in order to deliver these services? This is what I am trying to understand.

À (1005)

[English]

Mr. Rob Hamilton: What I was trying to say in my remarks was that by getting products approved quicker and reimbursed quicker Canadians would have access to them sooner.

[Translation]

Mr. Jeannot Castonguay: In your brief you say: “there is already a lot of promotion and advertising taking place in the consumer media in Canada made by companies.” The argument made is that if we advertise more – I am not sure if this should be called advertising or educating – it would lead to faster access to health care services. That is what I fail to understand. Moreover you say:

There is already a lot of promotion and advertising taking place in the consumer media in Canada made by companies. This has been occurring for several years and has resulted in some confusion and misunderstanding for consumers, patients and for the industry.

How are we going to reduce the confusion by advertising?

Finally what should be the role of the industry? You add: “the key point here is that we need greater clarity on what the role of the biotech and pharmaceutical industry is.” I am looking for answers to all these questions. How will it favor health care access when it has already created much confusion?

[English]

Mr. Rob Hamilton: What we're asking for is clarity on this issue. In the last few years there's been almost a blind eye turned towards public relations quasi-promotional efforts. In that gap, a lot of confusion has arisen about who is responsible for approval of messages, etc. What we're looking for is some clarity, and I think as pharmaceutical or biopharmaceutical companies we have a role to play. We have a lot of data. We probably know our products better than anybody else does, and we're looking to partnering in communicating the ins and outs of the drug in a fair and balanced way.

[Translation]

Mr. Jeannot Castonguay: My colleague had a short question, probably along the same lines.

[English]

The Chair: Thank you, Mr. Castonguay.

We'll take a small question from Ms. Bennett.

Ms. Carolyn Bennett: I think in everything we've been trying to do in Canada in health care around accountability and governance, everybody seems to think you have to keep the regulator and the people managing the system separate. If you were going to design a drug agency that was the regulator, do you think it's possible to do that and also begin work on a formulary or such things when the drugs that get approved cost provinces money?

Is there an inherent conflict in having the people at the table who actually will have to write the cheques for the things that are used be a regulator? Of course my colleague from Quebec has no trouble with this at all.

Some hon. members: Oh, oh!

Mr. Paul Drohan: I think there is the risk of a conflict of interest with the regulator not only approving the product for use but also paying for the product. The system we have is workable. If we can improve the system whereby the federal government approves the products, and then allow the provinces their jurisdiction for payment or reimbursement of the products, that I think is our first step.

The potential problem with going back to developing an agency and opening up the Canada Health Act and looking at who has responsibility for these areas is in the end with access to care. In the final synopsis, we're trying to improve access and improve the lives of Canadians. If we're to do that, I think we need to look at the most expeditious manner to provide these results.

À (1010)

The Chair: Thank you, Ms. Bennett.

I had a couple of questions. I was struck by your comment that for people working in this field in the lab, often it has become their life work, so they are experts of the first order. I'm wondering if you think there are sufficient numbers of experts in the field of recombinant DNA and enzymes and the various things you work with to form these expert panels. Or are they not all employed in companies such as yours?

For example, supposing I was the Minister of Health and supposing I said to you, I want to set up an expert panel to advise on these applications, in some hopes of speeding it up. Obviously the people at Health Canada have to be generalists, and a panel of experts for each specific field of endeavour would be good. Could you give me a list of names, for example, of people you would trust to be fair and who are knowledgeable, and who would not have a conflict of interest? In other words, perhaps some of them would come from your competitors, I don't know. How would we do that?

Mr. Rob Hamilton: My thinking on that is not so much to have basic researchers sitting on these panels to evaluate the drugs, but to have the actual physicians who could well be using these products. So if it's a psoriasis product, you can have a panel of dermatologists who are experts in the field, who know what the scope of the field is, etc., and you can use them to make recommendations to Health Canada on the approvability of the drug.

Similarly, on multiple sclerosis, you can have panels of neurologists who are independent-minded, who have not had any financial dealings with the companies involved, so that they can make neutral decisions.

The Chair: Would you agree with that, Mr. Drohan?

Mr. Paul Drohan: In our area it is the physicians, and they're not employees of our organization. I think in Canada we sometimes understate our expertise. And in this area there are numerous experts in Canada who could easily be identified to participate in these sorts of panels.

I think the other important issue, if we are to ensure transparency and thereby remove conflict of interest, is to not only bring the physicians in who are doing the research, who are caring for these patients, but also to look at all stakeholders: the sponsors, the patients who are at the table, the physicians who are involved in the clinical research, the physicians who may not be involved in the research but who will care for these patients. To bring a group like that together will ensure that not only do you have transparency, but also that all stakeholders are heard in the review process.

The Chair: I would have some concern about having the physicians involved in the clinical trials. Are they not somewhat reimbursed for their efforts by the company that's applying for this approval?

Mr. Rob Hamilton: I think in other jurisdictions where there are expert standing advisory panels, those physicians have to step aside from doing clinical trials so that there is no prejudice in the process.

The Chair: I see. So you have two groups, the one that's conducting the clinical trials and then others who are overseeing the approval process.

Mr. Rob Hamilton: Right. Those are standing committees, if you will, that sit for a number of years to ensure that they have expertise with the process and with the products that are coming through the approval process.

Mr. Paul Drohan: Madam Chair, I think another option, and part of the therapeutic access strategy, is to look at international reviews. So you have a membership of Canadians as part of that international review committee, but you also bring in members from around the world, if you find a disease state where we don't have the needed expertise in that area.

The Chair: Thank you. It's always ideal to have international panels of anything, whether we're talking about war and peace or approvals of things. Sometimes it's not quite so easy to manage.

On behalf of the committee, I want to thank you very much for your thoughtful presentations. The written presentations will be translated and then released to all the members of the committee. So we'll have a record of what you've told us. The thing I liked about this morning was that there were specific suggestions on how to cope with some of these problems you're facing.

We've very grateful. We are on a track of trying to increase transparency in all angles of this. So you'll be glad to know that. It's possible we might have a little interim report before the House rises for Christmas. We hope. If not, perhaps in the new year.

So thank you very much for your participation this morning.

We'll take a 20-minute break.

À (1035)

The Chair: I call this meeting back to order and welcome all of you to the Toronto hearings of the Standing Committee on Health during our study of prescription drugs.

I remind you that you have five minutes.

We'll begin right away with the representative from Canada's Association for the Fifty-Plus, president and founder, Ms. Lillian Morgenthau. Ms. Morgenthau.

Ms. Lillian Morgenthau (President and Founder, Canada's Association for the Fifty-Plus): Good morning, everyone. I'm Lillian Morgenthau. I am president of CARP. I wish to thank you all for the opportunity to appear before the members of this committee and present CARP's view on this very important area.

CARP, Canada's Association for the Fifty-Plus, is a national non-profit association of over 400,000 members across the country. We started in 1980. Our mission continues to be to promote and protect the rights and quality of life for mature Canadians. Our mandate is to develop practical recommendations for the issues and concerns of older Canadians. We do not accept government administration funding, which allows us to be independent.

We also get to our members through our magazine, which is read through pass-along by a million Canadians. We hope that the presentation I'm making today will be one that a million members will be very happy to hear about.

I'm very pleased to see this committee on health, as health is a major concern of our members. It is my hope that the deliberations that will come out of this meeting and the meetings across the country will establish a more agreeable, accessible, and compassionate health care system, especially in the area of prescription drugs.

CARP has maintained that any medication that is globally found to be therapeutic should be available to Canadians. Our patients deserve at least that.

To address rising costs, Canada has in place the Patented Medicine Prices Review Board, PMPRB, whose duty is to put drug costs in perspective. Therefore, our costs are reasonably priced, we hope.

We are, however, significantly behind in terms of the average number of days needed to issue an NOC by almost a whole year. We can stall all of this, but we shouldn't be stalling it. We should be passing the use of a drug, which is a good thing. All of these delays only add to the cost of any drug costs. They soar as days and years go by, and nothing is done. Every day means more money to the patient.

In the meantime, patients wait in pain and frustration to get a drug that is available in other countries or in other provinces. Certainly, once a drug has been approved and used elsewhere, we should be taking this into account and realize that other countries are not approving and paying for drugs that are useless. Why are we not utilizing their investigation and approval to our advantage?

You must look at the bigger picture, ladies and gentlemen. Drugs save money. Fewer visits to hospitals and doctors is only one aspect, but the greater picture is the relief for patients who suffer and can be helped with a proper medication. We must not deny Canadians this relief.

In the past, people didn't live beyond 65 years of age. Today statistics tell us that a male who reaches 65 can look forward to reaching 80 years of age. A female who reaches 65 will likely reach 85 years of age. You see, we still have it. Women are going to reach 85 years of age. But on top of that, we find that we now have over 100,000 North Americans who are 100 years of age.

À (1040)

This isn't done easily. We must review the times and allow faster access to drugs.

My time is up.

The Chair: Thank you, Ms. Morgenthau. You're such an experienced presenter.

Ms. Lillian Morgenthau: I beg your pardon?

The Chair: I said you're such an experienced presenter that you know when five minutes is up in your head.

Ms. Lillian Morgenthau: Always.

The Chair: Thank you very much.

We'll move on to the representatives of the Canadian Auto Workers Union. Today we have Mr. Dean Lindsay, national coordinator for retirees, and Len Harrison, a retired worker who is on the executive.

Gentlemen.

Mr. Len Harrison (Retired Worker Executive, Canadian Auto Workers Union): Thank you very much.

I am on the national executive board of the CAW retired workers and I'm president of the CAW retired workers, representing over 60,000 retired workers across the country and their spouses.

We are glad to be here and we're glad to talk about an ongoing problem that we've been involved in since the day we went down to see Brian Mulroney to try to stop Bill C-91. At that time the Liberals came out to us when we went up there--two busloads of us from the peninsula and Oshawa--and we were told then that they were going to kill the bill for us, not to worry about that, they would get rid of it and even get rid of the notice of compliance and not let evergreening ever happen. As you know, it didn't happen. The Liberals got elected and it didn't happen. We went back again. In fact, at the time we were down there the Globe and Mail, that left-wing newspaper, put an editorial in that said get rid of the notice of compliance, it's a sop to the manufacturers of drugs.

We went down the road there. We've been back to Ottawa many times in busloads. The most recent one was in June. We took four busloads down there. They wouldn't let us appear before the industry committee--which, I understand, Brian is a member of--but we packed that room for every day that hearing was on and the members of the committee turned up every day of that hearing. There is still nothing done, so we are here now to talk to you about what we would like.

What we would like, first of all, is for politicians to keep their promises. It goes back to the red book. I think it was the 1996 or 1997 campaign when the Liberals had in their red book that they were going to bring in a pharmacare program. I forget the group that met, a health council that Jean Chrétien brought together, and there were two big recommendations that came out of it. One was for a pharmacare program and the other was for a health care program, and we're still waiting for them. Every time I've been to Ottawa and every time I've talked to the committees I've always said I wasn't stopping until we get somewhere on this.

There should never be any evergreening and there should be no notice of compliance. I have told everybody I have met that a cabinet can meet today in Ottawa and get rid of the notice of compliance for us. They put it in; they can take it out. It only adds to the cost. And to tell us that just because we have that committee that meets in Ottawa on the costs that keeps the cost down.... From 1985 to 2000 drug expenditures have increased 296%. Drug expenses are the fastest-growing portion of our health care bill.

As far as living longer--and I don't take a drug, I take herbs and I take vitamins, and I call them drugs--drugs kill and hospitalize seniors. That's what they do. In certain instances they need to be used properly, and not only used to look after seniors and people who need help.

What we are recommending, first of all, is we want our health council established. Romanow made all those wonderful recommendations that everybody loved, and now they're set over there somewhere. There was an article in the Toronto Star the other day about it. That's quiet now. Nobody's saying anything. It's dying a thousand deaths out there, Romanow and his beautiful report. He wanted a pharmacare program. He wanted the industry committee to meet on evergreening and notice of compliance. He really wanted to get rid of that. He said it was wrong and we would have the price of our drugs cheaper. It would help us all.

We want that to happen. Get me that health council. This government now can, if it wants, get that health council in place and say to the provinces, we're going to put it in place, it's going to be transparent, we're going to see how you spend the people's money, and they want to know that. Then we'd get some people who are more interested in government and the ethics of government, and that's what we want too.

I want to come to the other part of this. The other thing I want to tell you is I read yesterday the Canadian Health Coalition's presentation to you, and I thought it was a great presentation. I wish I'd written it, or our researchers. One of the things I liked in that was they want a public inquiry into the pharmaceutical industry on what it does, how it conducts itself, how it gives money to government, and how it details with doctors and how it puts advertising in so doctors will give out more expensive drugs. That's all there now. You know all this, and there's nothing I can probably tell you about detailing and doctors.

We have a medication awareness program going that we started and we have a lot of anecdotal evidence. Dean runs the program for us now. We have retired workers going to retired workers to tell them about medications and tell them to make a good friend of the pharmacists. That's your best friend in chemicals, because you're putting chemicals into your body, for a lot of which the long-term effects you don't know. We emphasize that. We emphasize how to talk to your doctor and how to live a healthy life.

À (1045)

I eat a low-fat diet, I walk every day, I do some meditation, and I'm having the time of my life. And I'm going to live to be 100. I told my kids I was going to live to be 120 when I was 60, and my son said “Oh, no, Dad”.

The other thing I want to talk about is drugs that kill and hospitalize. Between 18% and 28% of hospital admissions are for drug-related things: over-medication, getting the wrong medication, too many medications. I would suggest to you that if it was any other segment of society, other than seniors, it would be a disgrace and an abuse. So what we do in Canada is we abuse seniors with medications. We abuse seniors with medications in hospitals and we abuse seniors with medications in long-term-care facilities, and we have to find a way to stop it. And the literature is out there.

When I was on the Council of the College of Pharmacists in Ontario, until the Tories got elected--I was the first person who took off--we talked about that. Go and talk to pharmacists about that and they have all kinds of great ideas. They're front-line people who know more about medications than doctors do. They should be in a setting with a doctor, where they could advise doctors. We have all that we can do, that you can do.

I'm going to finish off by saying this to you: I always come optimistic to a place, but I'm always pragmatic about some stuff. I think it was in 1987 or 1988 when I went to see Brian Mulroney, and nothing happened, and everywhere along the way nothing has happened. I'm still going back. I actually expect as much from this committee, to be honest with you--nothing's going to happen. That's my track record. We can give you everything you like. All the information that you need on it is out there.

The minister in charge of seniors in Ontario sat down with me when I was president of the United Senior Citizens of Ontario, and I had a great idea about getting all the stuff together and putting pharmacists on the front line, and teaching people, and putting ads in, and somebody stopped it. He said to me, “I haven't got all my ducks in place”, and I said to Cam Jackson, “No, Cam, somebody's killed your ducks”.

They're not going to do it for us. They're going to leave the seniors out there. They're going to keep overdrugging us. They're going to keep putting us in hospital. They're going to keep killing us, and that's what they're doing.

You can get all the information, you can read all the information, we can present you all the information, but only you can do something and show leadership and help the seniors who need helping in this country. You can help us. You can help us with better lives. My whole idea about life is a good quality of life. You're charged with that. If you do that, you'll be doing a great service to all of us.

Thank you.

À (1050)

The Chair: Thank you, Mr. Harrison.

Our next presenter is from Women and Health Protection, Anne Rochon Ford, who is the coordinator.

Ms. Ford.

Ms. Anne Rochon Ford (Coordinator, Women and Health Protection): Thank you.

I'm going to have to read my talk. I think that's the only way I can get through it in five minutes.

I want to thank you, first of all, for presenting us with the opportunity to present here today.

Prescription drugs and their impact on women's health is the singular area of focus of our organization, Women and Health Protection. Given that women have been the majority of the people to suffer serious harm from some of the worst drug and device disasters of the 20th century, such as DES, diethylstilbestrol; Même breast implants; the Dalkon Shield IUD; and more recently having served as one enormous, unknowing, worldwide population of research subjects for hormone replacement therapy, we have a particular interest in ensuring there are proper safeguards to prevent similar mistakes and tragedies in the future.

Women and Health Protection was established in 1998 as an initiative of DES Action Canada, one of the then partners of the centres of excellence for the women's health program of Health Canada. We continue to be funded by the women's health bureau of Health Canada and are administratively sponsored by the Canadian Women's Health Network, who I think you heard from in Winnipeg.

Our initial focus was to collectively respond with a gendered perspective to the ongoing transformation of those departments within Health Canada responsible for the approval and surveillance of prescription drugs and devices, formerly the therapeutic products directorate within the health protection branch, presently the marketed health products directorate within the health products and foods branch. I point out that distinction because I'll come back to it later.

The group is made up of a loosely knit collection of academics, health professionals, and women's health advocates concerned with the impact of health protection regulations on women's health. We produce discussion papers and materials on a range of issues relating to women's health and pharmaceuticals for both the general public and policy-makers. We meet on an intermittent basis with elected officials and select functionaries from Health Canada offering a gendered analysis of the issues at hand.

The points and recommendations I'd like to make to the committee today fall under four broad themes: first, the increasing medicalization of women's lives; second, the precedence of economic and industrial growth over public health in the field of drug regulation; third, the need for an evaluation of drugs and devices in the context of the full range of health care possibilities; and fourth, the need for solid consumer health information, not advertising.

First, on the medicalization of women's lives, to be more accurate, what we really want to say is not just that there's a problem with the medicalization of women's lives, but with the drugging of women's lives.

A pervasive onslaught of advertising geared to presenting just about every natural function and situation of a woman's life as having a pharmaceutical solution has bred a nation of girls and women geared to questioning that if they aren't taking a pill for something, maybe they should be. I'd refer you to publications such as this one, which is produced jointly by Rogers Communications and the Society of Obstetricians and Gynaecologists. It is quite chock full of the kind of advertising that I'm talking about and is widely distributed in doctors' offices across Canada.

Heavily backed and fuelled by the corporate media, we are led to believe that the solution for side effects to one medication can only be to take another medication. This is referred to by one of our members as “disease substitution”: that prescription drugs for heart disease make more sense than diet and exercise; that our stage fright, our fear of crowds, or poor communication with our mate can be helped more readily by a pill than by a support group, talking to a counsellor, or meeting with friends. Recently the news that there is now an improved medication in the United States to arrest our menstrual cycles has been presented in the media as perhaps a good thing. And our bothersome moods that accompany those pesky menstrual cycles have another pill altogether now.

Women are not the only targets of these messages, but we are frequently the primary target. This is because we are not only the greater users of prescription drugs, we also serve as gatekeepers of health care decisions, not just in the family but sometimes, such as in the case with some aboriginal communities, for the larger community.

We have historically been under-represented in drug research and as a consequence are frequent victims of adverse drug reactions due to inappropriate dosaging. However, we're pleased to see that through the critical work of Dr. Donna Stewart and her colleagues at the University Health Network here in Toronto, and others in the health research community, the issue of women in clinical trials is beginning to be addressed in Canada. We applaud that.

À (1055)

My second theme is the public health versus industrial growth theme. Our working group originally came together to collectively and individually present our concerns to Health Canada about the current system for drug regulation in Canada. At present, various members of our group are preparing briefs to present to the same office in Health Canada, the office of legislative renewal, as they undertake Canada-wide hearings over the coming months.

At the time of the 1998 hearings, we spoke of the fact that increasing control is given over to the pharmaceutical industry, with Health Canada relying on industry user fees for the bulk of its operating costs related to drug evaluation and approval.

We noted that in-house drug research laboratories, which were responsible for investigating drug quality, toxicity, bioequivalence, and clinical applications, were slowly being eroded and ultimately closed. We expressed serious concerns then, and will reiterate them at the current round of hearings, that the interests and needs of the pharmaceutical industry seem to be taking precedence over the general aim of public health--i.e., the very foundation on which the original Food and Drugs Act was premised.

With this enormous risk at hand, we remain unconvinced that the act indeed needs reopening and whether the changes that are truly needed, and which would uphold the key tenets of public health, could not be dealt with through other mechanisms, such as changes in regulations and guidelines.

It is unclear to many of us why the words “health protection” have been quietly removed from the branch that governs drug regulation within Health Canada. While there are no doubt justifications offered for this name change, its loss is symbolically important. The citizens of Canada need reassurance that protecting their health is what this department is about, not selling products.

I'd like to talk about drug evaluation in the context of the full range of possibilities. Drugs and devices must be evaluated in a much broader context than they currently are. By this, I mean that they must be viewed in the broader context of care and must be viewed through a lens that equally considers all possibilities for prevention and intervention, including no intervention, not only those solutions that are pharmaceutical.

Drugs must be compared to other intervention regimes, such as exercise, diet, adequate sleep, massage therapy, and safer non-chemical alternatives, in order to fairly evaluate cost-effectiveness and safety. It will always be much easier to pop a pill than to change lifestyle habits, much easier, more expensive, and potentially much more detrimental to long-term health. We feel that it is incumbent upon our national legislators to change that paradigm.

My final theme is health information, not advertising. You've heard from many others, I'm sure, on the subject of direct-to-consumer advertising, one of the key parts of the Food and Drugs Act under examination in the legislative renewal process.

Women and Health Protection has been working on this issue since our beginnings. We view DTCA as not only emblematic of many of the current problems of encroaching influence of the industry, drug regulation and surveillance, but as an issue that has a particular impact on women's health. As noted earlier, women are the primary targets of DTCA, not only for drugs used only by women, but for some that are used by both sexes.

Clever advertisers know that appealing to women is an important way to get their messages across. This is particularly problematic when the women they are trying to appeal to are young and vulnerable, as is strongly evidenced in the growing number of publications being put out by the manufacturers of contraceptive devices, which are spread around like fireweed in doctors offices and clinics.

Our colleagues who work in birth control clinics say that they find it very hard to resist putting these publications out, since there is so little else out there that gives girls and young women information they are looking for about choices in contraception and other health issues.

This leads me to the key problem with direct-to-consumer advertising. The information in the advertisements is not information, it is advertising. It tends not to tell the reader even what they need to know, let alone what other options may be available to them. Girls and women are thirsty for information about all their options when it comes to their health.

As our colleague, Dr. Peter Mansfield, in Australia, has said, “finding good unbiased health information today is like finding a needle in a haystack”. DTCA only makes the haystack bigger.

We need drug information that has not been produced exclusively by the very industry that stands to gain from the promotion of their particular products.

In 2000, Health Canada funded a pilot study called the Canada Drug Guide Project, which tested consumer friendly information drawn from the best available studies on a sampling of health issues. I've attached some examples to my presentation.

Á (1100)

The Chair: I'll have to stop you there, Ms. Rochon. You're well over your time.

Ms. Anne Rochon Ford: Okay. I'll conclude with my final four recommendations. Can I do that?

The Chair: Yes.

Ms. Anne Rochon Ford: First, any evaluation of issues relating to prescription drugs in Canada must first consider the differential implications for women and their health. Secondly, put public health and health protection over industrial growth and development. Thirdly, be placed in the broader context of its place in the care system with a host of options, not as products to be sold. And fourth, enforce and strengthen the existing prohibition around direct-to-consumer advertising in the Food and Drugs Act.

Thank you.

The Chair: Thank you very much.

Our next witnesses will represent Canadian Pensioners Concerned Inc. This morning we have the president and the past president, the president being Ms. Gerda Kaegi and the past president being Ms. Barbara Black.

Ms. Kaegi.

Mrs. Gerda Kaegi (President, Canadian Pensioners Concerned Inc.): Thank you very much.

I'd like to thank the committee for holding these hearings. I think it's important that you do so.

Len has expressed a lot of the passion I feel. You have the capacity to make a difference, and I plead with you, please make a difference.

We have spoken from Mulroney times. I've done presentations to the Senate industry committee; we've done them to the House of Commons, to every Minister of Health and every Minister of Industry. But CPC has taken one further step: we filed a consumer's complaint with the Competition Bureau with five other national organizations that were desperately, as you can see, engaged in this issue.

As to my brief, I will skip quite a bit, but I sent in a longer brief that I hope you've had a chance to read or will be able to read.

We raised three issues in our brief. The first one was drug costs and the issue of affordability. There we addressed the ability of low- to moderate-income citizens to pay for required prescription drugs, and we cited a number of studies. We noted also studies that showed that seniors are greater users of prescription drugs than any other large demographic group in Canada, and that those seniors spend more for drugs than other age groups, despite being covered by drug benefit plans.

The combination of low income and the need for prescription drugs has meant that people are required to choose between the basic necessities of life and prescription drugs. We know through the Canadian Institute for Health Information the incredible rise in yearly expenditures on prescription pharmaceuticals.

We also drew your attention to the fact that if prescription drugs are used outside a hospital, their cost becomes the responsibility of the individual.

We also noted how provincial governments are trying to control or escalate health costs by delaying or excluding new prescription medications from provincial formularies. Drugs not on the formulary are not covered by benefit plans.

Finally, we noted that all provinces now require co-payments from people on their drug benefit plans and that these co-payments tend to rise yearly.

Under those concerns we came up with three recommendations.

The first recommendation is that Canada must have a national pharmacare program that will be included either under the Canada Health Act or with the same set of principles applied to a new pharmacare act.

The second recommendation is we need a national pharmaceutical agency created through federal, provincial, and territorial agreements that will:

(a) purchase drugs to reduce the cost--there are studies done on how this negotiation has worked partially in Canada, but really in the United States with the HMOs;

(b) agree on testing and approval of drugs in an effective and expedient manner--and we're hopeful that the present initiative will go forward;

(c) agree that drugs that have passed the approval process will be made available to all Canadians on an equitable basis, regardless of province or territory--there's huge discrimination between one province and another, which leads to inequity;

(d) ensure that generic equivalents are recommended for substitution once they have been approved.

Our third recommendation under that category is that until a new national pharmacare program is introduced, we believe all drugs needed for catastrophic illnesses must be covered for all Canadians under that interim federal, provincial, and territorial agreement. Romanow and Kirby both referred to something like that.

The second area we dealt with was the special treatment given to the pharmaceutical industry under the patented medicines notice of compliance regulations of the Patent Act. We recognize the need to protect intellectual property rights; however, property rights must also be balanced against the public interest. We note that we are dealing with companies that have received public support through university research, tax incentives, and direct government grants and loans.

Canada and the United States are the only countries that have given extra protection by providing an automatic injunction to block the introduction of generic drugs to the market. President Bush in August of this year changed this situation in the United States, so only Canada is really left giving this special deal.

Á (1105)

Our concern is with the unnecessary cost to individuals and to the health care system through the now perfectly legal but morally questionable practice of market monopoly extensions or evergreening. We have noted that many new drugs that are introduced each year are only minor variations of existing drugs—and there are many studies to show this—but are higher-priced. The research and development Canada expected by instituting this special treatment regime has not occurred, as was documented by the Patented Medicine Prices Review Board.

Finally, we drew your attention to the fact that Canada's trade deficit in pharmaceuticals has grown immensely and is predicted to grow further. Under that issue, we came up with four recommendations.

The first recommendation is to impose an absolute limit of 20 years on really new drug patents, not slightly modified drugs. This is the trouble; so many are just slight modifications.

The second recommendation is the 20-year time limit should begin the moment the filing is submitted to Health Canada, and no additional patent should be allowed unless it is for a significantly different modification, and then it should be limited to one.

The third recommendation is to repeal the special regulations targeted at the pharmaceutical industry and treat the industry like any other patent holder, so that lower-cost generic versions can become available after the original patents on the medicine have expired.

Then my last point, which is unnecessary if my third point is followed, is limit the number of patents per drug to a maximum of two. In my brief I cited Losec. It's a drug I've used and two of my children have used. I went to the Health Canada site. I cited the fact the patent expired in 1999, but all the other patents go up to 2018, if I remember correctly.

Our last point was about the public advertising of prescription drugs. I follow the comments made by my colleagues. The brand-name pharmaceutical companies and the media are pressuring the government to allow direct-to-consumer advertising. Such advertising increases the pressure on physicians to prescribe more medications for new syndromes or so-called illnesses—and I picture the man leaping—or prescribe newer, higher-priced medications for existing conditions.

Direct-to-consumer advertising will increase the market for drugs that are usually of little value to the health and well-being of the public and divert money away from the development of drugs that are really needed.

Finally, we argue that advertising encourages people to look to drugs to solve their problems. That was our last recommendation: continue to prohibit direct-to-consumer advertising for prescription drugs and enforce the current rules.

Thank you, Madam Chair.

The Chair: Thank you very much, and for being so succinct and bringing your recommendations forward quickly.

We'll now move to the question-and-answer period and will begin with Mr. Ménard.

Mr. Réal Ménard: Merci, madame la presidente.

I'm going to speak in French. That's my mother tongue, and I like Quebec—and Toronto. And Mr. Gilbert Barrette too: he speaks French too.

Á (1110)

[Translation]

I have two questions. I am trying to convince my caucus that the automatic injunction does not make any sense, that it is a mechanism to prolong a patent beyond what the legislator had planned for. I agree on this point.

I have a hard time following Mr. Lindsay when he argues that there should no longer be a notice of compliance. If there were no longer a notice of compliance that would mean that drugs would be sold in Canada without Health Canada verifying that they are safe.

That is what it means since notice of compliance does not only refer to the extension of patents. This is linked to the question we need to answer which is whether or not we believe that Health Canada should be responsible for ensuring that prescription drugs and over the counter drugs are safe for people who use them. The flip side of the drug approval process is the right of Health Canada to recall some drugs.

Therefore I think we need to be careful when we advocate getting rid of the notice of compliance. If we get rid of the notice of compliance then we take away Health Canada’s responsibility which is to ensure the safety of drugs. On this issue I do not agree with you. I agree we should make sure that patents that were designed to last 20 years do not in fact last 24, 25 or 26 years. I fully agree that generic drugs should be brought to market as fast as possible once we have reached the 20 year period.

Mr. Lindsay do you agree with me that getting rid of all forms of notice of compliance results in taking away an important responsibility from Health Canada that could create unsafe situations for consumers?

I will have a second question directed at Mrs. Ford.

[English]

Mr. Len Harrison: This is how I understand the notice of compliance.

Bill C-91 was passed, giving a 20-year patent to the drug manufacturer. For 20 years they sell that drug to the public, and for 20 years the people see what happens to that drug. Sometimes the drug gets recalled, or whatever happens. But when the 20 years are up, if I'm the maker of the generic drug, I go to Health Canada and say that I want to make a notice of compliance that I want to make that generic drug. That drug has been on the market for 20 years.

They say, “Well, Big Pharma, the company that owns it, has said to us that you're still infringing on the patent.” I say, “We're not.” They say, “It doesn't matter; you go to the courts to settle this.” So that's all they do.

If that happened and we got rid of the notice of compliance and I went and said to Health Canada that I wanted to produce the drug, I then would have to produce the identical chemical drug that has to be tested as the original patent or else I can't sell it in Canada. So it is not a health issue; it's an issue of being able to spread out.

It's easy for the companies that have money to say “We'll take you to court”, because they set the price of that drug and they're making billions of dollars, so they'll keep us off the market for another two or two and a half years. It's well worth paying for those lawyers. That's the whole idea of a notice of compliance.

[Translation]

Mr. Réal Ménard: I know what you mean, you are right but we call it a notice of compliance for the second holder.

You talk about those that want to manufacture the drug after the 20 year patent. You argue that we should not prolong it and I agree but don’t you think Health Canada still has a responsibility with respect to safety? Therefore we understand one another and I agree with what you said.

Let me follow up with a question to Mrs. Ford.

I believe the Members of Parliament receive your news letter. I think I have seen at the office. The witnesses we heard told us that they wished Health Canada was more efficient with regards to the drug approval process since it is lacking in that respect. Some of them think we should have a joint approval process; for instance when a clinical monograph is submitted in Washington, in Australia or in Europe there should be an exchange of data to dispense us from doing duplicate clinical studies.

In one of the article I read you were concerned with international harmonization and regulation of new drugs. Does that mean that your organization is against the idea of Canada having its own drug approval process?

Á (1115)

Mme Anne Rochon Ford: We are not really against that idea but I think it should be studied more in depth. We also published a flier that goes further than the article from the news letter.

Our concerns with international harmonization deal more specifically with standards that we believe everyone should achieve. This is really what we are questioning as well as the lack of vision with respect to drugs for women. So I don’t think we say anywhere in that news letter that we are against Canada having a drug approval process.

Mr. Réal Ménard: Mr. Lindsay I don’t know if your organization has an opinion on the subject. Pharmaceutical companies circulate lots of samples that they give to doctors, to professionals in the medical industry.

Would you be in favor of the creation of a mandatory declaration registry? In other words all pharmaceutical companies circulating samples for drugs that are not sold would be required to declare them. We believe there is a link between the drug samples given to doctors and the ability to prescribe such drugs.

Has your organization thought about the issue of drug samples circulated by pharmaceutical representatives?

[English]

Mr. Len Harrison: Just so you know, I'm Len Harrison. This is Dean Lindsay.

We have had discussions about that. We are opposed to any detailing. You know, the pharmaceutical industry spends a tremendous amount of money sending detailers to see doctors. And when they send detailers, the more visits you get.... It means you write more prescriptions than your peers. So they send you there to do that. And in doing that, they'll give you samples. We're opposed to that.

That's why we want to take a look at the industry and the things it does. It spends more money on detailing, going to see the doctors, and on advertising than it does on research. Just reading the Canadian Health Coalition's thing, they say the pharmaceutical companies in this country have a terrible record on research for innovative drugs. He is talking about innovative drugs.

But no, we're opposed to doing that. Because what happens when the newer drugs come out--you have to understand this too, because when they are doing these drugs.... Anybody who gets Prevention magazine, opens it up and sees a drug, and it goes on page after page after page about what that drug can do to you.... We are the experiment. They don't know.

You take a number of the flags that go up in the States when you hear about new drugs that come on the market...and they're given these drugs so they can give them to people free. It's wrong, and we're opposed to it.

Mr. Réal Ménard: Madam Morgenthau, I hear something about you, that you're a nice person and you are very involved in Toronto. I would be glad to have information about your organization.

Ms. Lillian Morgenthau: Good. I'll send it to you if you'll leave me a card.

Madam Chairman, first and foremost, I did stop at page 5 because I felt that was the correct thing to do. However, there were pages of mine that I didn't read because I'm sure you will get the transcript, and a lot of them were for recommendations.

With respect, one of the things you wanted on your list was adverse side-effects and the interaction of other drugs, which hasn't as yet been discussed. We have a recommendation and a solution that we feel is easy.

We feel the monitoring that should be done by pharmacists and doctors should continue. The reason for many of the reactions and interactions is that the patient takes the particular drug and finds that it is not doing what it's supposed to do, and he stops taking it, but he doesn't inform his doctor and he doesn't inform the pharmacist. So in my opinion the doctor must monitor the patient. The patient, when he goes to see a doctor, must take all of his medications so we don't have interactions.

There must be a computer system set up with proper protection for privacy that says how many doctors a patient goes to, because you can go to ten doctors and get ten prescriptions and each one can interact. So if we have a system where we know that the pharmacist is following his patient--he phones in a week or two--or the doctor has his secretary phone in a week or two to find out what's going on with the patient, that patient will not find himself in trouble.

The other thing is, I was listening to what they were saying about 20 years of patent medications. Now, I feel there are some things that drug companies are doing that perhaps are not 100%.... However, they get a patent for 20 years. That doesn't mean they have 20 years of selling that patent, because by the time they get through all of the knocks and by the time they get through their trials, they don't have 20 years. They have less.

I'm not the advocate of a drug, but I do want to see more research. I do want to see trials. I do want to see us have the drugs that are out there.

There was one in B.C. that didn't get through and it was stalled until the point came that there was no point in putting it on because the generics would get there.

The generics were the best thing that ever happened to the drug companies, because it started competition. But they're no lilies, either. They're out there for their profits too. Perhaps we should look at what they really should be charging for their generic drugs.

As far as ads are concerned, let's be realistic. The ads are coming across the border. If there are going to be ads, what we want is an ad that is Canadian so that a Canadian resident who looks at an ad coming across the border for a drug that he cannot get will not.... He should know what a Canadian can get, what his access is. We really have to look at what Canadians can get and what they are able to afford.

Seniors cannot afford the drugs that we have. Seniors have many drugs that are not on the formulary. I agree with Gerda on this. There should be a way for a senior to get what they need for diabetes, and I'm not talking about insulin. I'm talking about all the other things that go with it.

Á (1120)

There is very little out there to concern yourself with as far as affordability is concerned. There's nothing in this group that says anything about affordability. Affordability is a very major part of a senior's budget, because they're on fixed budgets.

The Chair: I have to stop you there, Ms. Morgenthau, because Mr. Ménard's time is up.

Ms. Lillian Morgenthau: I took their time. I'm so sorry.

The Chair: We'll now go to Mr. Castonguay.

[Translation]

Mr. Jeannot Castonguay: Thank you, Madam Chair. Thank you to our guests. I think my question is for Mrs. Rochon Ford.

You talked about the importance of education with regards to various drugs on the market. Some pharmaceutical companies also discussed with us education but they have a difficult time differentiating education and advertising. Do you feel pharmaceutical companies have a role to play in educating the public? If not then who should do it?

I think we agree that there a great need for education to be done and not only targeting elder people. With regards to this issue I will talk to you about women. In my opinion, as Mr. Harrison said, all Canadians should know that these are chemical products that have a purpose but that you have to know how to use them. They act as a double edge sword: they can be good or harmful depending on how they are used. I would like to hear you comments on this issue. Someone else might want to add something.

Á (1125)

Mme Anne Rochon Ford: I am convinced that pharmaceutical companies have a critical role to play. However they should not be the only ones. The information that they dispose of, coupled with the fact that they have access to research and information on the products they produce are critical factors. However the contribution from other researchers, consumers and non-profit organizations which possess sometimes different information and which are actively concerned with these issues will provide an overall view of the problems.

The issue with the information provided via advertisement is that it remains partial information, it representation only a fraction of what is needed. It does not give all the possibilities including perhaps the choice of not taking any drugs in certain cases. In short I think pharmaceutical companies have a role to play with certain drugs and illnesses but it shouldn't be exclusively up to them.

In a project financed by Health Canada we produced good examples of information gathered from several sources including pharmaceutical companies. I have added some of these examples in my presentation. The problem is that the project fell through as I understand it. It nevertheless constitutes a good example and it should be encouraged. I therefore would like to say that I believe that pharmaceutical companies have a role to play but that we should also include others that have important things to say.

Mr. Jeannot Castonguay: Who do you think should lead this program? I know that many diverse stakeholders should all be able to contribute. Yet, there should still be a leader. Do you think we should establish a group to take care of it out of Health Canada?

Mme Anne Rochon Ford: Yes, I think the leadership should be assumed by Health Canada and that we should ask for other stakeholders to contribute.

Mr. Jeannot Castonguay: Thank you Mr. Harrison.

[English]

Mr. Len Harrison: We many years ago went to Green Shield and a couple of other people to get some money to run a medication awareness program.

Since then we've been able to negotiate. We wrote to our negotiators, not last time, the time before, and asked for two cents an hour, to come out of our active members, of every hour they worked to go into a retired workers fund. We had a penny the first year, and a penny the second and third year. Dean is now the coordinator of that fund, which produces our medication awareness program.

We'll leave some of the leaflets. It's only a brief outline of our “retired worker to retired worker” program. We have pharmacists who come in. We also have exercise programs in our halls for our retired workers at different times of the day.

So what we need is more of a commitment from other people. We didn't just run to the government and say “Give us some money. We want to do this.” We said “We're going to do this. It's very important to us.” Then we went to the corporation and said “It's going to save you money. You help us.”

I think if we can broad-base this, not only have it go to select groups that can get some money...but then we'll also have Health Canada, or whoever will give us some money there, to carry it beyond that so that the people in the workplaces find out what's going on. Everybody who works in Chrysler probably has aging parents or parents who are in some kind of difficulty. We could advertise to them the pitfalls and get them to understand that what you put into your body is very important, and the things to do about it.

I think the drug companies should be involved. I think Health Canada should be involved. General Motors should be involved, and all the union organizations in this country should be involved, and every other social organization, every seniors organization, for sure, should be involved in that.

That's how bad it is out there for seniors and drugs.

The Chair: Ms. Kaegi would like to comment.

Mrs. Gerda Kaegi: From the personal experience of being a parent with four children, our pediatrician in Winnipeg prescribed a medication, which was a new drug, for one of our sons. It damaged his teeth. Nobody told us. I knew the physician did not know. It came out later.

Nowadays when you go to a drugstore a pharmacist prints out all the indications, all the concerns, and I assume most of them do this. You have to involve the college of pharmacists. On that education side, physicians don't have the time to know this, and that's the trouble with the marketing to physicians, which you and others have so correctly raised. They get the samples, but the trouble is, they don't really know the implications. They don't have the breadth of the knowledge. The pharmacist does, and that, to my mind, has become a critical source of information.

If I'd only had this some 40 years ago, my son would not have had damage done to his teeth.

So this is a critical issue. It's not just seniors. It's children.

I was on the Metro Homes for the Aged advisory committee in Toronto, and we had 2,300 seniors in our homes, plus extended facilities. We had a medical director for all the homes, Dr. Murray Herst. He came in and said “I'm going through the medication of every single person in our home.” He sent people home. They were being poisoned by the medications they'd been on.

So this is an issue of getting the information in the right place, and in many cases, to my mind, it's the pharmacy. Of course, people do go to other pharmacies, and if you can have that central registry, that will at least protect many consumers.

I'm sorry for interjecting.

Á (1130)

The Chair: That's fine.

Ms. Morgenthau.

Ms. Lillian Morgenthau: Madam Chairman, that goes back to what I said: monitoring. If you monitor, you won't get sick.

The Chair: Mr. Lindsay.

Mr. Dean Lindsay (National Coordinator, Retirees, Canadian Auto Workers Union): I would like to turn the attention of the committee to our brief. On page 3, we talk about the support for a national drug agency to evaluate and approve new prescription drugs, to provide an ongoing evaluation of existing drugs.

Also, there was a comment made, and again to refer to our brief on page 7, our organization joins with the Canadian Medical Association and the Canadian Pharmacists Association with an opposition to any type of direct-to-consumer advertising. I want to make that very clear. That's part of our organization. We're opposed to that.

The Chair: You'll be relieved to know that we have not yet had a witness in all these weeks of hearings who has recommended direct-to-consumer advertising. So you are definitely in the majority. As a matter of fact, it seems at this point to be unanimous.

Ms. Bennett is next.

Mr. Jeannot Castonguay: As a follow-up, you mentioned the word “monitor”. In my view, and I would like to have your reaction, don't you think it's more important to educate people? It's more important for them to know how to fish than to supply the fish.

I believe it's not only at the senior level. I believe that this education should start early, by realizing that these medicines are not candies. They might be good, but they might hurt you. I would like to have your feedback on this. If you learn that when you're young, perhaps you might have a better chance when you reach my age that you'll understand that it's dangerous to--

Ms. Lillian Morgenthau: Are you a member of CARP yet?

Mr. Jeannot Castonguay: No, but I'll get my card, because I am that age.

Ms. Lillian Morgenthau: Let's be realistic. You're right. Everything you say is absolutely correct, but it's not practical, because there are too many things that you just said. There are ads out there; they're coming across the border; we can't stop them. How are you going to stop them? You're not going to stop them by not having something here. And I'm not advocating it; CARP is not advocating it. What we're advocating is that we have our own and we offset it. You can't get what comes across the border, but people want it, so why don't we have our own way of approaching ads? Let's have our own boundaries or rules; let's not be set up by another country.

What you just said is true. Everything you said is true, but it's not practical. Education starts at the beginning.

I feel that a drug must stand on its own. It cannot stand on being advertised, being given to a doctor, and lots of samples set up. Educating the doctor is the important thing, and educating the pharmacist.

I don't know about other pharmacists, but our pharmacist will not issue anything unless he's spoken to the doctor and seen what other medications are out there and what reactions will take place. That's why I said we need a real computer set-up, where we know how many doctors they've gone to, getting a new prescription from every doctor. That's where your reactions come in. You open up a senior's cabinet, and all the drugs fall out.

You talk to the people who look after the water. Our water is being polluted by drugs being dropped into the toilets—half-done ones. We have to educate people not to do that. The biggest thing they found in our water were anti-birth pills. Maybe that's why we have an urban sterility.

We aren't educating our people—you're absolutely right—but the education has to be out there. We do a bit in here, but every one of us has a newspaper that goes out. We should be telling them in our papers what they should not be doing. They should not be throwing half-empty drugs down their sewer. So you're right.

Á (1135)

The Chair: Thank you, Dr. Castonguay.

Ms. Bennett.

Ms. Carolyn Bennett: I would like to explore with the panellists the Romanow recommendation for a drug agency.

I noticed in the concerned pensioners' brief that you have this agency buying drugs as well as.... I guess I have some concern that you can't be the regulator and the person trying to get a deal. I heard Ms. Rochon Ford very clearly around the whole issue of health protection. I guess I would like to know, if there were to be an agency—maybe a health protection agency—that was a regulator, what the mandate of that agency would be. What would it do? What wouldn't it do? Could it eventually negotiate towards a common formulary, the way we had hoped the provinces might buy in, as I think Romanow had suggested, and then deal with the issues around gender and kids and seniors and around what you'd expect in research?

Maybe I should just stop there. How would you see it work? I think it is in the CAW brief as well. Then, as I think we've heard, should Health Canada get back into the business of disease prevention and health promotion—back to its core business—and let the agency do an agency-like job as a regulator?

Mrs. Gerda Kaegi: If I could respond initially, yes, I agree with your last point: I think it's crucial for Health Canada to get back to health promotion and disease prevention activities.

For the agency we're looking at, we're coming at it from the perspective that yes, we need the mechanism for approval, for the testing and the evaluation of drugs. That's critical. And the Patented Medicine Prices Review Board has pointed out, as have other studies, how few new drug medications are coming on. Despite over 1,100 new prescription numbers in about the last four years, only about 68 are really new.

We have to have the testing; we have to have the evaluation. But I was coming at it, and CPC is coming at it, from the perspective of cost. Yes, we're assuming the testing will be done; it has to be done. Yes, we need to also do the negotiations that studies have shown Canadians are not doing. If you buy in bulk, you can negotiate prices down.

The costs paid by HMOs in the United States are about 50% less than those the American public are paying who aren't connected to the HMOs. The research has shown the provinces do not really negotiate prices down. The larger the bulk market you have, the better your power to bring down a price. That's where I was seeing the agency.

Ms. Carolyn Bennett: I think you can do that as a collective. I just have a worry that this would be the job of the agency—

Á (1140)

Mrs. Gerda Kaegi: No, no.

Ms. Carolyn Bennett: —because your brief says we need a national pharmaceutical agency that would purchase drugs.

Mrs. Gerda Kaegi: Yes, but the testing is done through Health Canada—and proper testing—but the agency comes out of the initial start of the provinces and the territorial and federal government ministers to cooperate on this. That's where we're coming from. We're taking as a given that proper evaluation should be reinstituted and strengthened at Health Canada.

Ms. Carolyn Bennett: The CAW should have a brief on the agency.

Mr. Dean Lindsay: Yes, that's exactly what we would want to see, that the agency would provide that type of education. Through the agency you could provide the education we're currently doing right now with our medication awareness program, which is not just for seniors. We do it for our active members also. There was a need.

Ms. Carolyn Bennett: Do you use it as a watchdog on direct consumer advertising as well? I think what this committee has heard is that the stuff that's out there is a little questionable and that Health Canada doesn't have the time and the energy.... It's a complaint-based system—but maybe even then complaints are not dealt with—it's not an audit-based system. Would you put that into the agency as well?

Mr. Dean Lindsay: Certainly you could do the education on that, and also monitoring—we're opposed to any type of direct-to-consumer advertising—and use the agency for that.

Ms. Carolyn Bennett: Does anyone have anything to add?

Ms. Lillian Morgenthau: Many of these agencies should have some stakeholders on them, because today we have tremendously educated people. Our education of ordinary people is high. You should always have a stakeholder.

Ms. Carolyn Bennett: I agree. You've speaking to the converted.

Ms. Lillian Morgenthau: Carolyn, it's impossible to have a committee without having a stakeholder on it. And it doesn't have to be us. You can do a rotation.

I'm glad you agree.

Ms. Carolyn Bennett: Anne taught me all I know about this. It's a good point.

Mrs. Gerda Kaegi: I think there are some excellent recommendations in Romanow, in particular the one for a national or common drug formulary. I think what's needed—and Romanow did some of this, but it should go even further—is that there be a stepping back and looking at other models that are working effectively elsewhere. I don't have details about the model in Norway around this whole issue of how a drug agency might work, but I can send them to you if you don't have them.

Ms. Carolyn Bennett: I think we worry, whether in the case of the food inspection agency or some other, that somehow or other you're trying to protect the public and make sure your product's sold. There seems to be some blurring that isn't clear. I think what I'm hearing from you is you want the protection side clean and looked after; then other chores can be sent somewhere else.

Ms. Anne Rochon Ford: Yes, and it's slipping. I think that's the problem with it. I think the protection side, when the Food and Drugs Act and these branches were set up, in fact was capable of functioning well and did put disease prevention, health promotion, and public health in the forefront, and I think that's eroding, and it's our main concern. So if one message comes out of this committee, I hope it would be to see a revival of that real protection of the public.

The other point I wanted to make--and I think Romanow does refer to this, but it again needs further examination--is that the whole WHO essential drugs program needs a closer look as something Canada needs to follow more closely. There are so many duplicate drugs on the market that only serve to confuse the public. I think we need to get back to a basis of what is essential and what do we need, and that model put forward by the World Health Organization is worth exploring.

The Chair: Thank you, Ms. Bennett.

Mr. Masse is next.

Á (1145)

Mr. Brian Masse: Thank you, Madam Chair.

I'm going to start with a question of Mrs. Kaegi. Your presentation was really good. It encapsulates some of the struggles the industry committee has been going through for more than a year and a half.

I can only convey my personal frustration and anger, and I don't even know how to express my disappointment, that we haven't been able to date to move on this issue of evergreening. Just yesterday we were meeting on this, and again tomorrow we will meet on the issue.

It's interesting, because in your presentation what it does note is the fact that George Bush is a progressive compared to this country on this issue, and that's a fact, because they've actually made strong movements, and we're the last remaining country to have this situation. I would like you to provide to the committee, though, because I think it's important that they hear in the testimony, what happened on your consumer complaint with the Competition Bureau. Because that was really almost an extreme measure that had to come about because of the lack of the will to address this right now. So can you provide some details about that?

Mrs. Gerda Kaegi: Thank you very much for the question.

Yes, it was extremely interesting. There were six organizations: ours, the National Union of Public and General Employees, the Congress of Union Retirees of Canada, the Canadian Federation of Nurses Unions, the Canadian Health Coalition, and the Consumers' Association of Canada. Those were the six. We were totally frustrated. We've been stymied over the years, so we tried this avenue.

The initial response from the Competition Bureau was no, it's not our jurisdiction. Then I think some of the events in the spring leading up perhaps to the debates in the industry committee and the House of Commons to refuse to accept other deputations and so on.... Somewhere along the line the Competition Bureau changed its mind and said they would accept the brief.

Then, surprisingly, in July we got, on very short notice, an invitation to appear before them, which we took quick advantage of. I happened to be in Ottawa or passing through, so I stayed over. They told us they'd give us an hour. We had about two hours. At least we have a sense that somebody is prepared to look at the monopoly practices.

The political side has not been prepared to act. They've looked at it, but they haven't acted. So we're praying if you can't do it, maybe the Competition Bureau will do it. We won't hold our breath, but we are very hopeful. At least it's another avenue. We'd like you to do it, though.

Mr. Brian Masse: There are a number of us who are still working on that and still believe in it. Just yesterday we were reviewing a situation where for a generic to produce a drug that had been out for 20 years, you have to satisfy all the different patent challenges that have happened, and that's one of the problems that's out there. It's not about producing just one to one, it's actually several that have to be accomplished.

I'm going to move down the line here and go to Ms. Rochon Ford. You talked about youth and their vulnerability, I believe, to advertising that is happening in mediums other than just television. We always assume television, and I live on the border, so I receive all these ads where at the end of the ad.... In these ads there are people who are all happy and stuff like that, they're getting all this information about the drug and then they have maybe about two minutes about all the side-effects that happen.

Maybe you can share with us a little bit on the vulnerability of some of the youth with some of the advertising that's happening in magazines and other mediums, such as the Internet, which we should be having an eye on, I suppose.

Ms. Anne Rochon Ford: Certainly it's a big problem because of the cross-border issue, but also because it's multiple media, as you said.

Another place for it is in posters in the washrooms of university campuses and high schools, and in the birth control clinics of those places as well.

The difficulty is that the people who are getting out good and useful messages are underfunded, and are competing in this incredible miasma of sensory overload. It makes it very hard for young people, in particular, who are just learning all of this, how to distinguish.

One of the helpful things that is happening in some high schools is the teaching of critical thinking around publicity and advertising. It isn't happening enough, and I'd like to see a whole lot more of it, but I think it's a really important start, and it would be a good recommendation coming out of this committee.

Mr. Brian Masse: Would community health centres be a great vehicle to be able to get in touch with? In my constituency we have some of those centres in areas where face-to-face interaction and intervention is needed, as opposed to any type of leafleting or general messaging, and stuff like that.

Ms. Anne Rochon Ford: Yes, I think community health centres are an important place, but I think it's important to go first to the places teens go most—their schools, birth control clinics, Internet cafés. Those are the places they hang out.

I didn't bring any examples, but in pubs on university campuses now, Berlex, the manufacturers of Diane-35, a drug for severe acne, has placed ads, and this is the latest one. This drug also functions as birth control; it is not approved for birth control, but functions as birth control. The girls are hearing about it on the grapevine, and they are seeing this ad, which is reinforcing it, and they are getting inappropriate information about the drug's safety. It is not a safe drug to be taking for birth control; the liver toxicity issue is huge, and it has not been approved in other countries or here for that.

So there's misinformation out there, and they're getting it in an overdose in the venues where they go to most. I say let's counter it with good and accurate information in those same venues.

Á (1150)

Mr. Brian Masse: Yes, and coupled with another drug, it can be quite a cocktail, I guess, to use while you're developing through your youth.

I saved my last question, Madam Chair, for the CAW.

The Chair: Very quickly, as you're almost out of time.

Mr. Brian Masse: How complicated was the piece that you did together with Green Shield? If the government took a leadership role, is it possible for other groups and organizations to do that type of a strategy? I like that practical advocacy element. We're used to it in the place I'm from, where we ended up having to do those things. Is it something that you can transplant to other groups and organizations?

Mr. Len Harrison: When that was taking place, I made a phone call to Green Shield and asked for x amount of dollars, and we had a discussion about it. I knew some people in Green Shield, and they said “That sounds like a great idea”, so we produced the program.

But then I went to another company and I asked for $25,000 to run the program for the year. And there, the person at the other end immediately said yes. When I got off the phone, I said “Damn it.” My buddy, Johnny Dobbin, who had actually put the program together, said “What's the matter?” I said “I didn't ask for enough, obviously.”

Some hon. members: Oh, oh!

Mr. Len Harrison: So we produced it. We didn't try to reinvent the wheel, but went and got all of the information that was out there, and did a person-to-person course.

We will send to the committee our exact course for the whole thing and how it's run. Dean looks after that, and has revised that course since coming on board. But the first time we did it, we had a select group of people, and it worked well everywhere we went. We had our people trained to do that.

They're not people who tell you what's wrong with you. If you've got something wrong with you, we'll advise you to go see your pharmacist. That's their function. That pharmacist talks to them, and then they also talk about their health. People get scared so that they don't know how to talk to doctors; somehow they freeze in doctors' offices. There's anecdotal evidence of a woman who took a friend in and said to her, “You've got to ask him questions.” Yet the friend didn't ask him a question. When they got outside, the friend said, “Well, if there's anything he wanted me to know, he'd have told me.” So we try to train people to do that. We also give them a medication awareness guide, which lists all of the medications.

Wrapping up quickly, when people talk to me about Shoppers Drug Mart rolling out all of your prescription drugs, it's not the answer, because that's all they roll out; they don't roll out anything else you're putting into your mouth. And some of the heavy stuff now is non-prescription.

Mr. Dean Lindsay: If I could just add to that, one of the successes of the program is that we do train seniors. So we have retirees and seniors speaking to seniors about issues of overuse, misuse, and those types of things.

But in direct answer to your question, we also have health professionals come in as part of the program. We have doctors and pharmacists come in, so people can ask the really specific questions at the end of the program. But throughout the program, it's seniors dealing with seniors on issues of basic medication, use and misuse.

The Chair: Thank you, Mr. Masse.

Mr. Barrette.

[Translation]

Mr. Gilbert Barrette: Thank you, Madam Chair. Hello.

I agree somewhat with Mrs. when she says that drugs have permitted a better quality of life, that they enable shorter stays in medical facilities and that they even in some cases prevent hospitalization.

However, I know that in medical facilities large amounts of drugs are used for all sorts of reasons. I also know that many new drugs on the market unfortunately bring no benefits whatsoever. This bugs me and worries me a lot.

Mr. Harrison told us about some drugs that I thought he would ask us to ban. According to what he told us they lead to hospitalization and even death. I probably misunderstood but that is what I heard. I would like him to expand on this issue.

Á (1155)

[English]

Mr. Len Harrison: I've never implied that medicines can't help you; I'm telling you that if I needed a drug regime, I'd go to see my doctor and I'd talk to my doctor about it.

In fact, years ago I went to my doctor when I had the flu. I worry about the flu, because my father died of Asian flu when he was 50 years old during the big thing in 1957. When it came on my chest, my doctor said “No, Len, you're all right”. She said “I'll give you this prescription. Go home, rest, and drink lots of liquids, and in about seven or eight days you'll be feeling better.” I said “What's the prescription?” She said “Antibiotics.” I said “I don't want antibiotics. Antibiotics won't do anything for flu”, and I passed the prescription back to her. I said “Now what should I do?” She said “Well, go home and take Aspirin and Tylenol and drink lots of liquids, and in about seven or eight days you're going to start feeling better.”

Some hon. members: Oh, oh!

Mr. Len Harrison: That's the problem with drugs. When 28% of the population is being admitted to hospital, there is something we have to do about it.

My wife is on drugs for high blood pressure, and they are controlling her high blood pressure really well. She's dieting, she's exercising, and she's taking her medication responsibly; that's what we have to do.

No, there is a lot of good stuff that can happen from drugs, but the trouble is, if we don't do something sensible, there are a lot of bad things that are happening to people from drugs.

[Translation]

Mr. Gilbert Barrette: What do you think of the internet market? Do you think it is safe for consumers, more specifically for elders? Can it lead to an increased and uncontrolled consumption of drugs?

[English]

Mrs. Gerda Kaegi: Yes. It gets back to the issue that I think we raised earlier. The trouble is--and Lillian Morgenthau referred to it earlier--if people go to different sources, they're putting themselves at risk, and that goes back to the issue of education. If you put yourself at risk, and we do this in many ways in our daily life, you take gambles. But I think many people don't understand the gamble they're taking with medications--and non-prescription medications, because we know natural medicines can be very dangerous too.

So it's a question of getting at the education, and I like the response of getting to the kids in the high schools, getting to the parents of those kids, getting that education out about the importance of thinking before you ingest anything--think before you do it. There was a headline in the paper this morning about trans-fatty acids--I think that was the story--about kids eating the kinds of snack foods that are horrendous for them, and we're paying for it now. I'm saying the more education you get to young people, their parents--all through the ages--the safer we'll be. And those Internet pharmacies won't have the success they do now.

But let me make one clear point. I get spam at the university from which I am now professor emeritus, and last night I couldn't get on my e-mail. There were 106 spam messages, most of them no longer the sex stuff, though there's some of that; they were for drugs. It was advertising for getting your drugs within 24 hours. That's wrong and it's dangerous, and somehow we have to get to the public to say don't go there, drive them out of the market. Unfortunately there are too many people who are gullible and who will do that. But it angers me every single day.

I'm sorry. I don't know if that helps.

Ms. Anne Rochon Ford: Can I just add a point to that?

The whole notion of critical thinking is one that starts very early, and there are excellent models. Thirty years ago in high school, I remember sitting around taking apart advertisements on television, and that had a huge impact on my consciousness about that. There are good models out there. Unfortunately, it often takes just one parent who says my husband works for the pharmaceutical industry, or whatever, who says we're opposed to that; we don't like what you're doing. So there is a bit of a battle there. But I do think that's an incredibly important way to get at young people, by guiding them through, watching advertising, looking at the Internet with them, and talking with them as a group to learn how to take it apart.

Â (1200)

The Chair: Thank you, Mr. Barrette.

Seeing no further hands, I will on behalf of the committee thank you very much for the efforts you have put forward. I'm hoping Mr. Harrison will not be able to say a few years from now that he did this and nothing happened again.

There are always competing interests in this field, as Mr. Masse is learning. He thinks he's frustrated this year on the industry committee. I was there in 1994 when we did a big review of the notice of compliance and automatic injunctions, and it was very frustrating.

But it's easier from the perspective of the health committee, because we are here for the protection of health, the prevention of disease and adverse reactions, all those things. So our mandate is very clear., whereas when the industry committee does it, their mandate is to encourage and support industry, so it makes it difficult.

I think you'll be happy with our recommendations, but whether the industry minister will do what the health committee says is highly questionable.

Mr. Len Harrison: I just wanted to say you met with some of our local 707 retired workers on one of our trips to Ottawa. I just want you to know that when they came back they had a lot of nice things to say about you. That's what Kevin told me.

Ms. Anne Rochon Ford: Can I just ask a question as to what the relationship is between this and the whole legislative renewal process that's going on? Will you feed into it--the recommendations? Where will the timing--

The Chair: What do you mean by the legislative renewal?

Ms. Anne Rochon Ford: Well, the whole process that's taking place within the legislative renewal office, the hearings across the country in response to proposals they've put forward about the changes, from the Food and Drugs Act to the new Canada Health Protection Act.

The Chair: What is the legislative renewal office? I have no idea. Our relationship is to the Minister of Health. We advise her. She does not control the notice of compliance regulations and the automatic injunction business.

Ms. Anne Rochon Ford: Within Health Canada, there is an office of legislative renewal that has been set up in order to specifically transform and change the many acts that come under the Food and Drugs Act. They're proposing a new health protection act.

The Chair: We have been asked by the minister on occasion to do a study that is relative to some project. We have not been invited by the minister to participate in that one.

It is sheerly a bureaucratic exercise, and I'm actually a little bit annoyed they're calling it “legislative” renewal, seeing as they are not legislators. It should have been called “administrative” renewal, because they are administrators. I will speak to the minister about that. It's ridiculous to call what bureaucrats are doing on their own at the request of their minister legislative renewal. That's why, obviously, it's natural for you to ask us about that, because we're legislators. But as far as I know, they are not doing anything that has to do with legislation.

Ms. Anne Rochon Ford: They're proposing legislation that will then go before you. That's the process.

The Chair: They are now preparing legislation on what subject?

Ms. Anne Rochon Ford: On the Food and Drugs Act.

The Chair: Oh, the Food and Drugs Act. I wouldn't call that legislative renewal. I would call it a review of the Food and Drugs Act, the preparation of a new act or amendment.

Ms. Anne Rochon Ford: What is the timing for the release of your findings from these hearings?

The Chair: Well, we knew when we started we were taking a very broad look. When we did reproductive technology, it took two years, so I wouldn't be averse to the idea that this might take two years. But that does not mean we will not report. We are hoping to report in an interim way before the House rises, if we can get some agreement around the table. I can't promise a report before the House rises for Christmas, but that is our plan.

But of course, to get anything, we have to have some agreement from the majority of the members to approve a report.

Ms. Anne Rochon Ford: It would be extremely beneficial if what you hear going across the country could be fed into that. There is a series of public hearings going on across--

Â (1205)

The Chair: Into what?

Ms. Anne Rochon Ford: Into that bureaucratic process that's happening as well. Because many of the same people are appearing at these same hearings on these very same issues.

So just in terms of the optics, it's difficult for us as consumers and citizens of Canada to not feel frustrated that we're being asked multiple times to get up and say the same things about what the issues are around prescription drugs from our particular perspectives.

It would be extremely beneficial if there were discussions between the two processes that are going on. The legislative renewal office is headed by Len Kuchar in Health Canada.

The Chair: He is the top bureaucrat in charge of that process? Oh, I can't wait to get back there and phone him. I am absolutely enraged that they are holding hearings on the same topic.

Is it on the topic of prescription drugs? And are they travelling as well?

Ms. Anne Rochon Ford: Yes.

It includes broader...the other acts, the Quarantine Act and the others that come under that jurisdiction, but prescription drugs is one of the main issues that's being discussed. They've put out a document called Health and Safety First, which contains the recommendations for what the change in legislation should look like. It includes things like direct-to-consumer advertising. All the things we've been talking about today are in there.

The Chair: We are completely and totally unaware of that exercise, despite the fact that officials from Health Canada were among our first witnesses as we began this study. So needless to say, there will be a slight fuss raised back in Ottawa next week because of what you told me.

Mr. Brian Masse: How many shadow governments do you have?

The Chair: We don't have anybody.

If in fact your party ever goes to power, you will find that controlling bureaucracy is one of the major challenges.

Thank you very much for your time this morning.

The meeting is adjourned to the call of the chair.