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37th PARLIAMENT, 2nd SESSION

Standing Committee on Health

EVIDENCE

CONTENTS

Wednesday, October 29, 2003

1335

The Vice-Chair (Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ))

Mr. Terence Young (Chair, Drug Safety Canada)

The Vice-Chair (Mr. Réal Ménard)

Mr. Terence Young

The Vice-Chair (Mr. Réal Ménard)

Mr. Terence Young

The Vice-Chair (Mr. Réal Ménard)

Mr. Terence Young

1340

1345

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

Mrs. Deanna Groetzinger (Vice-President, Communications, Multiple Sclerosis Society of Canada)

1350

Ms. Kris McDonald (Volunteer and Member, Multiple Sclerosis Society of Canada)

Mrs. Deanna Groetzinger

1355

The Chair

Mr. Réal Ménard

Mr. Terrence Young

Mr. Réal Ménard

1400

Mr. Terrence Young

Mr. Réal Ménard

Mr. Terrence Young

The Chair

Mr. Brian Masse (Windsor West, NDP)

1405

Mr. Terrence Young

Mr. Brian Masse

Mr. Terrence Young

Mr. Brian Masse

Mr. Terrence Young

Mr. Brian Masse

Mrs. Deanna Groetzinger

1410

Ms. Kris McDonald

Mr. Brian Masse

Ms. Kris McDonald

The Chair

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

1415

Mrs. Deanna Groetzinger

Mr. Jeannot Castonguay

Mrs. Deanna Groetzinger

Mr. Terence Young

Mr. Jeannot Castonguay

1420

Mr. Terence Young

Mr. Jeannot Castonguay

Mr. Terence Young

Mr. Jeannot Castonguay

Mr. Terence Young

Mr. Jeannot Castonguay

The Chair

Mr. Gilbert Barrette (Témiscamingue, Lib.)

Mr. Terence Young

The Chair

Mr. Andy Troszok (Vice-President, Standards, Canadian International Pharmacy Association)

1435

1440

The Chair

Ms. Della Croteau (Deputy Registrar, Director of Programs, Ontario College of Pharmacists)

1445

The Chair

Mr. Ray Chepesiuk (Commissioner, Pharmaceutical Advertising Advisory Board)

1450

The Chair

Dr. Jeff Poston (Executive Director, Canadian Pharmacists Association)

1455

1500

The Chair

Ms. Ruth Mallon (Vice-President, Pharmacy Services, Ontario Pharmacists' Association)

The Chair

Ms. Ruth Mallon

The Chair

Ms. Ruth Mallon

1505

The Chair

Mr. Réal Ménard

Ms. Ruth Mallon

1510

Mr. Réal Ménard

Mr. Ray Chepesiuk

Mr. Réal Ménard

Mr. Ray Chepesiuk

Mr. Réal Ménard

Ms. Ruth Mallon

Mr. Réal Ménard

1515

The Chair

Mr. David Thomson (Chief Executive Officer, Ontario Pharmacists' Association)

Mr. Réal Ménard

Dr. Jeff Poston

Mr. Réal Ménard

The Chair

Mr. Gilbert Barrette

Mr. Ray Chepesiuk

1520

The Vice-Chair (Mr. Réal Ménard)

Dr. Jeff Poston

The Vice-Chair (Mr. Réal Ménard)

Mr. Gilbert Barrette

Mr. Andy Troszok

The Vice-Chair (Mr. Réal Ménard)

Mr. Gilbert Barrette

1525

Mr. Andy Troszok

The Vice-Chair (Mr. Réal Ménard)

Mr. Brian Masse

Mr. Ray Chepesiuk

Mr. Brian Masse

Mr. Ray Chepesiuk

Mr. Brian Masse

Mr. Ray Chepesiuk

1530

Dr. Jeff Poston

Mr. Brian Masse

Mr. Andy Troszok

The Vice-Chair (Mr. Réal Ménard)

Ms. Bonnie Brown

1535

Dr. Jeff Poston

Ms. Bonnie Brown

Dr. Jeff Poston

Ms. Bonnie Brown

Dr. Jeff Poston

Ms. Bonnie Brown

Mr. Andy Troszok

1540

Ms. Bonnie Brown

Mr. Ray Chepesiuk

Ms. Bonnie Brown

Mr. Ray Chepesiuk

Ms. Bonnie Brown

Mr. Ray Chepesiuk

Ms. Bonnie Brown

Mr. Ray Chepesiuk

Ms. Bonnie Brown

Mr. Ray Chepesiuk

Ms. Bonnie Brown

Mr. Ray Chepesiuk

Ms. Bonnie Brown

Mr. Ray Chepesiuk

Ms. Bonnie Brown

1545

Mr. Ray Chepesiuk

Ms. Bonnie Brown

Mr. Ray Chepesiuk

The Vice-Chair (Mr. Réal Ménard)

Ms. Bonnie Brown

The Vice-Chair (Mr. Réal Ménard)

Ms. Bonnie Brown

The Vice-Chair (Mr. Réal Ménard)

Mr. Jeannot Castonguay

The Vice-Chair (Mr. Réal Ménard)

Mr. Jeannot Castonguay

Ms. Della Croteau

1550

Mr. Jeannot Castonguay

Dr. Jeff Poston

Mr. Jeannot Castonguay

Dr. Jeff Poston

The Vice-Chair (Mr. Réal Ménard)

Mr. Jeannot Castonguay

The Vice-Chair (Mr. Réal Ménard)

The Chair

Dr. David McCutcheon (Assistant Deputy Minister, Health Services Division, Ontario Ministry of Health and Long-Term Care)

Ms. Susan Paetkau (Director, Drug Programs Branch, Ontario Ministry of Health and Long-Term Care)

1615

Dr. David McCutcheon

1620

Ms. Susan Paetkau

1625

Dr. David McCutcheon

1630

1635

The Chair

Mr. Réal Ménard

1640

Ms. Susan Paetkau

Mr. Réal Ménard

Ms. Susan Paetkau

Mr. Réal Ménard

Dr. David McCutcheon

Mr. Réal Ménard

Ms. Susan Paetkau

Mr. Réal Ménard

The Chair

Mr. Jeannot Castonguay

1645

Dr. David McCutcheon

Mr. Jeannot Castonguay

Dr. David McCutcheon

Mr. Jeannot Castonguay

Dr. David McCutcheon

Mr. Jeannot Castonguay

Dr. David McCutcheon

1650

Mr. Jeannot Castonguay

Dr. David McCutcheon

Mr. Jeannot Castonguay

Dr. David McCutcheon

The Chair

Mr. Gilbert Barrette

Dr. David McCutcheon

1655

Mr. Gilbert Barrette

Dr. David McCutcheon

Ms. Susan Paetkau

The Chair

Ms. Susan Paetkau

1700

The Chair

Ms. Susan Paetkau

Dr. David McCutcheon

The Chair

Dr. David McCutcheon

The Chair

Dr. David McCutcheon

The Chair

CANADA

Standing Committee on Health

NUMBER 066

2nd SESSION

37th PARLIAMENT

EVIDENCE

Wednesday, October 29, 2003

[Recorded by Electronic Apparatus]

· (1335)

[English]

The Vice-Chair (Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ)): I call the meeting to order, please. We're going to start.

We have two witnesses this afternoon. Welcome.

We're going to start with Drug Safety Canada, and after that we'll have the Multiple Sclerosis Society of Canada.

From Drug Safety Canada we have Terrence Young. You have the floor. You have five minutes to make your points.

Mr. Terence Young (Chair, Drug Safety Canada): Thank you.

Is the chair not here?

The Vice-Chair (Mr. Réal Ménard): She's supposed to come soon.

Mr. Terence Young: Okay. I ask because she's my member of Parliament.

The Vice-Chair (Mr. Réal Ménard): She will be here in five minutes.

Mr. Terence Young: Is that part of my five minutes, Mr. Chair?

The Vice-Chair (Mr. Réal Ménard): Yes, it is.

We'll start, and when Madam Brown comes, she'll take the chair.

Mr. Terence Young: Thank you.

My name is Terrence Young. I'm the chair of Drug Safety Canada. This presentation and the work we do is dedicated to Vanessa Young, my daughter. She died in March 2000 due to the prescription drug Prepulsid. She was 15 years old.

Pharmaceuticals are an extremely important topic because of one key fact: 10,000 Canadians die every year in relation to prescription drugs. This is the equivalent of a full 747 crashing every two and a half weeks somewhere in Canada forever. All drugs have side effects--not some drugs, all drugs.

The truth is that most of these deaths are preventable. They occur because the most profitable companies in the world, which I call major pharma, do everything they can to make sure our institutions, our doctors, and our patients hear and say only good things about their drugs. They provide our institutions with so much money that criticism is absolutely stifled and ordinary people have no way to know what's safe and what isn't.

You can take any institution in our society where we are supposed to develop critical thought, and they provide money, fees, and donations to every one of them--from government to hospitals to universities to patient groups.

Some of you know me and my family's story. I'm certainly not a radical. I'm a former Conservative member of provincial Parliament. We had no warning when Vanessa died. We had no warning that the drug she was taking was dangerous. Neither did the other 5,000 people who are suing Johnson & Johnson in the United States and Canada to try to get some settlement, some fairness out of it.

The week we lost Vanessa I set out on a journey, and this is primarily what I've discovered in three and a half years of research: this industry--the major drug companies--is corrupt from top to bottom. And in three and a half years, nothing substantial has been done at Health Canada to make the system any safer.

I can also tell you that drug safety is not as complicated as the drug companies would like us to believe. They use tons of fine print, misleading jargon, and false figures when we try to find out by their warnings if our drugs are safe. When they want us to buy their pills, they use slick TV ads and pamphlets written at a maximum grade 6 level. They want us to follow our doctors' orders, because they know something that most people don't know: most doctors don't read the warnings either.

Before going any further, I want to congratulate the government on two initiatives: banning corporate donations to political parties to reduce that influence, and being the first country to set up a system to export cheap copies of patented drugs to the third world. Both are excellent initiatives and absolutely the right thing to do.

I have three major allies in my task. First, I have the truth. Second, I have an e-mail network of dedicated and knowledgeable advocates that you absolutely wouldn't believe. It's fantastic. We get e-mail messages and articles from learned journals all over the world daily. And I also have you. I have the Parliament of Canada. I believe you're here for the right reason, and we're counting on you to act.

What changes do we need?

First, even after three and a half years we still don't have regulated patient information leaflets to give proper warnings to patients. That is our first and most important recommendation.

Second, reporting suspected adverse reactions to prescription drugs is voluntary; therefore, every figure that's printed on prescription drugs, in the warnings, in the monographs, and mostly in the media, is a lie. It is far higher--up to 100 times higher.

Third, we spend millions of dollars on new drugs that cost more and are no better than the drugs they replace. We should bring back the Norway rule. No drug should be approved to treat a condition in Canada unless it is proven to be effective and safe or safer than the one it replaces. Fewer patients would die, patients would get better care, and it would save our health care system billions of dollars.

Fourth, we still allow Health Canada drug reviewers to hold private, closed-door meetings with drug company officials where no minutes are taken. That means someone who could make a drug company $100 million a year by approving their drug goes into a room and has a private meeting. Just imagine if that were a judge in a civil or criminal case. We need an arm's-length drug safety agency, arm's length from government, to become a key partner in an integrated health care system.

Fifth, things are going the wrong way. It's getting worse, not better. The drug industry has persuaded our government to put $190 million into approving drugs faster. In the United States, they did that in 1993. Since 1997, seven major drugs were pulled off the market after killing and injuring hundreds of thousands of people. They included Prepulsid. If the U.S. wants to test drugs on its population, that doesn't mean Canada should. Where the illness is not life threatening, there is no need to hurry the approval of drugs.

Sixth, the drug companies and media are pulling out stops to approve direct-to-consumer advertising, which I believe would be the single greatest threat ever made to public health in this country, and frankly, to free speech. We are increasingly exposed to scaremongering ads designed to drive us into our doctors' offices in abject fear asking for their pills.

I'd like to show you just briefly, if I may, an ad taken out of the Oakville Beaver. Madam Chair, you might have seen that ad. It says that one out of six will develop prostate cancer, and there is a 1-800 number you can call. There's no answer on the number; it's disconnected. They never intended to answer that number. This is simply to drive you to their website and to create goodwill with Metroland and the Toronto Star companies. They are the dollars they pump into our newspapers so they'll avoid the anti-drug stories.

In the lastest issue of Macleans, the drug companies have actually bought the cover. It says, “Five Ways to Make Canadians Healthier”. It's an insert. Here are the ads for the drug companies, each worth approximately $30,000. There's one for Bayer; one from the Canadian Lipid Nurse Network, probably money from Pfizer to help sell their drug Lipitor; and one from AstraZeneca--the whole centre of the magazine.

· (1340)

I've been trying for months to get Macleans and other media outlets to print a story that I think is very important for health safety about a drug called EPREX, which was contraindicated for subcutaneous use in every country in Europe last December. Health Canada refuses to act. Macleans won't cover the story because it would cost them too much money. It's the same with the others.

Here is another one, a disguised ad for Lipitor. It talks about getting your cholesterol checked. It's very interesting. The world's largest-selling drug is Lipitor, $5 billion a year, and it has never been proven to reduce heart attacks. The other cholesterol-lowering drugs are the same.

These are examples of how much money is being pumped into the media, and we don't get the truth. We don't get the stories that tell us how to protect ourselves.

Here's the Globe and Mail, Monday morning, an insert that in my guess would be worth $100,000 in revenue. On the back, Becel margarine is advertising, with a picture of a scalpel, that you should eat Becel, as if that means you won't have heart surgery if you eat Becel, which is another unproven claim. The rest is full of drug ads. This is what they do now.

If this is what they do now, if they were able to market directly to consumers, we wouldn't see any negative stories in the media about drugs. We already have a problem with media ownership: it's too concentrated. But with their unlimited marketing dollars, we wouldn't see anything. So it's actually a threat to free speech, and I plead with you to kill this issue, to step on it right away.

Drug companies are still taking doctors on free trips to Jamaica to curry favour with them and build a debt of gratitude. You can check the Rx & D website. Click on the little word you see in the corner that says compliance and you'll find that in the last two years they've taken doctors to Whistler on ski vacations and to Jamaica for a weekend away--the best food, the best booze. Supposedly that's continuing medical education. What it is, is building debts of gratitude. It's against their own rules, but guess what the fine is? It's $15,000. A $15,000 fine to a major drug company is like you or I dropping 10¢ or 5¢ in the street; it's absolutely nothing. They break the rules continually. They give fax machines, televisions and VCRs, free samples, coffee cups. It should be stopped entirely. They should have a system similar to what they have for parliamentarians.

Coroners, when they investigate drug deaths, as they did with the seven deaths from Prepulsid at Joseph Brant Hospital, use a standard of proof that is higher than that of any court in the world--it's called cause and effect; it's a clinical standard. And that absolutely prevents us from finding out when drugs are killing people. The standard they should be using is association: was this death associated with the use of this drug? They use cause and effect, and just as with the tobacco industry, it protects the drug companies from having to pull their drugs off the market. We should be using a standard of association.

Let me tell you what I mean, how powerful this is. By cause and effect, cigarettes do not cause lung cancer; they have never been proven to cause lung cancer by cause and effect, if that's the standard they use. The drug companies break open the champagne when they say yup, they weren't able to prove it again. Meanwhile, if they used a proper test, of course people would say there was an association.

Drug companies treat their patents as property without regard for worldwide public health urgencies. I'm a conservative, but I don't believe anyone should ever own a molecule. If the human genome is important enough for public health, then no one should own it. Molecules should be the same. I don't mean drug companies shouldn't get a fair return on their equity and their investment over a period of years, just like we do with monopoly phone companies or any other monopoly. But no one should be able to hold back a molecule.

We saw the most disgusting display two years ago when 26 drug companies sued the government in South Africa to prevent them from trying to save the lives of 26 million people in the subcontinent who were HIV positive. This is absolutely disgusting.

I'd like to leave you with one final thought, if I may. If anyone has read the book The Constant Gardener by John Le Carré.... It's fiction, about a fictitious drug company and a fictitious drug that killed hundreds of people. But I can tell you from all my research, it's actually quite realistic. Here's what he said at the end of his book--after you've read the book:

With luck I shall not be spending the rest of my life in the law courts or worse, though nowadays you can never be sure. But I can tell you this. As my journey through the pharmaceutical jungle progressed, I came to realize that, by comparison with the reality, my story was as tame as a holiday postcard.

· (1345)

So I ask you in Parliament to be courageous. I ask you to sever the inappropriate influences the major drug companies have with our institutions, with the media, and with the medical profession, and I ask you to put patients first. Your actions will address this outrage and help end the death of thousands of people in Canada every year, and you will be on the side of the angels.

Thank you very much.

The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Thank you very much, Mr. Young, and welcome to our hearing.

We'll move on now to the Multiple Sclerosis Society, Deanna Groetzinger, vice-president, communications, and Kris McDonald, volunteer and member.

Mrs. Deanna Groetzinger (Vice-President, Communications, Multiple Sclerosis Society of Canada): Thank you very much. I'm Deanna Groetzinger. I'll start and then turn it over to Kris.

The Multiple Sclerosis Society of Canada is very pleased to provide input on issues related to prescription drugs that are of concern to people who are affected by multiple sclerosis.

Multiple sclerosis, or MS, as it's known, is a chronic disease of the central nervous system that unfortunately often leads to severe disability. Studies indicate that Canada has one of the highest rates of MS in the world. Usually diagnosed between the ages of 20 and 40, MS is the most common simple nervous system disease of young adults in Canada.

You have received our written brief in which we focus on the high cost of drugs and access to drugs, as well as the importance of health research for people with MS in Canada.

Before I summarize some of our recommendations, however, I would like to turn the floor over to Kris McDonald, who will speak from some of her personal experience.

· (1350)

Ms. Kris McDonald (Volunteer and Member, Multiple Sclerosis Society of Canada): Thank you.

I am a person with multiple sclerosis. My first symptoms began in 1975. At that time, MS was very difficult to diagnose, so my MS diagnosis didn't occur until 10 years later, in 1985.

What I live with every day is the damage from the five or six attacks that I had in that intervening 10-year period. I have been partially disabled from a professional career as a medical underwriter in the life and disability insurance field, and I act as a consultant for the MS Society on insurance matters, trying to explain the complex world of insurance to people outside the industry.

I was able to work part-time at various positions for which I was grossly overqualified, because I needed to have part-time work and because of my mobility restriction. I have been totally disabled since 1997.

Because MS is usually diagnosed between the ages of 20 and 40, young people's lives are disrupted as they're starting families and careers. MRI technology has made diagnosis much faster, and frequently at younger ages.

Four federally approved drugs have become available since the mid-1990s. These drugs are able to slow down attacks, make them less frequent and severe, thereby minimizing or even eliminating the kind of disability I've experienced. However, treatment must begin very early, before the neurologic damage occurs, damage that I deal with every day.

These drugs are expensive, with an average cost between $12,000 and $24,000 a year. This is clearly outside the resources of most Canadians without a drug plan or some kind of financial support from government. Qualification for these drugs and financial support are not available to all Canadians on the same basis, at the same cost, and on the same timetable.

Here are a few examples. In Nova Scotia, after approval, people pay only the pharmacy dispensing fee and any shipping cost to get the medication. In Ontario, the approval process from the doctor's prescription to payment for the medication can add as much as six months to the time before the patient actually is able to take the medication. The province of Quebec is quite timely and generous in its medication provisions. However, in Newfoundland, only the very poor can qualify for government support and payment of their medication regimen.

I know these are provincial regulations over which you have no control, but access to drugs should not be dependent upon where a Canadian with MS lives, how much they can earn, or whether they have a drug plan available.

Deanna will explain to you how the MS Society believes your committee can be of help to all Canadians with MS.

Thank you.

Mrs. Deanna Groetzinger: Thank you.

As Kris has explained, access to prescription drugs is a significant issue for people with multiple sclerosis. Cost is a major concern. As Kris mentioned, drugs to treat MS are very expensive, ranging in cost from $12,000 to $24,000 a year. We welcome the promise in the 2003 first ministers' accordon health care renewal to provide reasonable access to catastrophic drug coverage by the end of fiscal year 2005-06. However, we urge that the government speed up this timetable by a minimum of 12 months.

Another theme in our recommendations is access to drugs. We urge that reviews of therapeutic products be carried out in a transparent, timely, and efficient manner. Today it takes, on average, 717 days for new drugs to be reviewed in Canada. This is more than double the target of 355 days that the federal government has set for itself. The government should ensure that Canadians have faster access to better and new drugs through a regulatory system that is efficient, well-resourced, rigorous, and comprehensive.

But once a prescription drug is approved, that's not the end of the story. The government must ensure that active post-market monitoring strategies and standards are in place that allow safety and effectiveness to be evaluated and that this information is communicated to consumers.

Far too often, people do not know where anything is in the process. If they mention a side effect or something that they believe should not be going on with their prescription, they can communicate that to their physician. They have no idea at all if that is actually relayed to the proper authorities.

Finally, the federal government should provide stable and adequate funding for health research to enable Canadian researchers to advance knowledge leading to new and better treatments for disease. We certainly applaud the efforts that have been made around the CIHR.

We also note that stem cell research has great potential for people with multiple sclerosis because of the possibility of breakthroughs that will lead to a cure for MS. We applaud the government for having introduced and passed legislation in the House of Commons that will provide a regulated framework for stem cell research in Canada.

In conclusion, the Multiple Sclerosis Society of Canada is grateful for this opportunity to present our views on this important topic. We look forward to the results of the study, and we are happy to have this dialogue today.

· (1355)

The Chair: Thank you very much.

We'll now move to the question and answer period, beginning with Mr. Ménard.

[Translation]

Mr. Réal Ménard: Thank you.

Mr. Young, I’d like you to know that your testimony is clearly of great value to this committee. Our Chair has told us about your ordeals and your situation. I of course recall hearing about the struggle you led, but I do not recall—please forgive me—the name of the company that marketed this product. I’d like you to remind us, please.

Once it was aware of the events you have told us about, what did this company do, to your knowledge, to change the situation?

I will then come back to some of the actual recommendations you made to us.

[English]

Mr. Terrence Young: Thank you very much for the question.

The company was Johnson & Johnson, who are the people who make our baby powder, the baby powder we used on Vanessa when she was a baby.

What did they do about the situation? Absolutely nothing until they were ordered to. There was a “Dear Doctor” letter sent out in February 2000, faxed to every doctor in Canada--which was too late.

But in the United States they had already put a black box warning on the same drug, Propulsid or cisipride, because the President of the United States had basically ordered them to, not officially but off the record. President Clinton had been taking omeprazole and Propulsid at the same time. He actually might have died had he taken them with the wrong timing or too much of them. They found out later, so he ordered them to, or they voluntarily put a black box warning on the drug. So American patients would get a real warning that said “May be fatal” and be careful.

I asked them what they did in Canada. They did nothing. We had no warning.

Once the warning went out in February, our family doctor didn't see it. He was away in Florida and didn't call us to tell us to stop taking the drug. We had no notice. Vanessa died. Finally, Health Canada at that point said, we are ordering them to take it off the market, and they did order them to take it off the market, but for some reason, months later, August 7.

What happens is that the drug companies negotiate with Health Canada officials. They have private meetings. They view them as partners.

Dr. Wendy Arnott, who is the vice-president--she's not a doctor; she's a PhD, and they keep calling her “Doctor”, so they have me doing it now--testified in the inquest into Vanessa's death that they view Health Canada as their best customer. If Health Canada is Johnson & Johnson's best customer, who is protecting Canadian patients?

[Translation]

Mr. Réal Ménard: So you say that there were two shortcomings on the part of Health Canada that can be clearly identified: the department officials were slow in demanding a regulatory warning, as should have been required by their role, and they delayed removing the drug from the market. But the drug is still not authorized in Canada.

Have I understood your testimony properly?

¸ (1400)

[English]

Mr. Terrence Young: Yes, that's correct. They didn't give the same warning in Canada as in the United States, and when Health Canada told them they had to do a proper warning, in January 2000, they negotiated with them for four or five weeks and delayed it until Vanessa died.

Then the drug was ordered off the market. But here's what's very interesting--and this is why I say these major pharmaceutical companies have no ethics whatsoever. They're still selling it in over 40 countries, for one reason: they haven't been ordered not to. They're fully prepared to watch a certain number of people die. It's in their business kit. They know how much the legal fees will cost them, and that's the way they do business.

By the way, six months after Vanessa died I ordered Prepulsid over the Internet. It came from a place called Vanuatu, near New Zealand. They're still selling Prepulsid back into Canada over the Internet. They'll say, well, we didn't know that's where it was going--which is actually quite laughable. They pay a company called IMS, and they know every prescription that your doctor and every doctor in Canada writes, not with your name on it, but every prescription. They send their sales reps out to see what they call “high-scrip docs”, the ones who write a lot of prescriptions. That's where the sales reps go with all the gifts and the free dinners and stuff. They just ignore the ones who don't write a lot of prescriptions. So they know very much what they're doing, and they're fully prepared to keep selling it and watch the body count rise, as long as the legal fees don't get too high.

I have to tell you, Johnson & Johnson is doing the same thing right now with another drug, called EPREX. It was contraindicated for subcutaneous use--that is, under the skin--in every country in Europe in December 2002.

They refused to act in Canada. Health Canada refuses to act and make them contraindicated. So my question is this: How many people will have a severe reaction and perhaps lose the use of their kidneys or have their kidneys destroyed and be on dialysis for life, from last December until Health Canada and Johnson & Johnson decide to finally contraindicate the subcutaneous use of EPREX?

It's this relationship that's inappropriate, and I find that Health Canada is basically useless for those kinds of things.

[Translation]

Mr. Réal Ménard: Basically, what you would like is for Health Canada to have a much more rigorous system for monitoring and overseeing; that’s the first demand you expect of us. I have trouble imagining that, in spite of all the publicity, in spite of the whole battle you have waged for many years, that Health Canada can continue to be so negligent with regard to these issues.

Have you been in touch with the officials of Health Canada recently? Have you been in contact with the Therapeutic Products Directorate?

[English]

Mr. Terrence Young: Thank you, no. I don't contact Health Canada. I have found Health Canada to be a black hole. I don't get straight answers. I get documents full of words that don't mean anything. Frankly, I have found them to be very dishonest. I'll give you one prime example.

A pharmacist at Joseph Brant Memorial Hospital in Burlington, Ontario, did a study after Vanessa died that showed seven out of ten people in that hospital were given Propulsid, the same drug that killed Vanessa. Seven out of ten were given it inappropriately, when it was contraindicated, and they died. The truth is they might have died anyway--they might have. But Health Canada had the report for a year and a half, covered it up, and would not release it until it was obtained through freedom of information by the Canadian Medical Association Journal.

We're calling for an independent drug agency that is separate from the government and separate from the people who are running Health Canada now, that will issue proper warnings in plain language that people can understand, that not only lists how to protect yourself from the drugs, but actually lists alternatives to taking the drug that goes right into the patients' hands.

We're asking that doctors, when a patient tells them about an adverse reaction, send a fax or log onto the Internet and send it to Health Canada saying they have a suspected adverse reaction for this drug. Here's the patient's age, condition, and what they reported. It would be a wonderful early warning system. It would save lives.

Health Canada has done nothing substantive in three and a half years to deal with either of these issues. They publish documents, they use nice words, and they never do anything.

Thank you.

The Chair: Thank you, Mr. Young.

Mr. Masse.

Mr. Brian Masse (Windsor West, NDP): Thank you, Madam Chair.

To carry on with the line of questioning here, I want to expand upon the notation you had that there have been private meetings with Health Canada and there has not been any documentation of meetings. What proof or what type of evidence do you have of those meetings and any knowledge contravening policy?

It disturbs me that that type of behaviour is happening.

¸ (1405)

Mr. Terrence Young: Well, that type of behaviour is actually condoned. The government has encouraged Health Canada officials to partner with the drug companies, and it's a very big problem. It's inappropriate, certainly.

I should tell you, there are whistle-blowers at Health Canada who have whispered into the telephone when they're talking to me. They do tell me that they're so afraid of losing their jobs and their pensions that they will not come forward.

Now, there are some others who have. Unfortunately, some of them are in a different group, the animal vaccines group. Dr. Margaret Haydon and others have spoken out when things were inappropriate.

I spoke with one lady, who I think is extremely credible, who was a former Health Canada employee and knows the situation very well. Dr. Michele Brill-Edwards is very credible, and she sacrificed her job to speak out. She paid the price. She's the one who first told me that this is the way they handle those drugs.

I couldn't agree with you more that it's totally inappropriate. There are so many ways that major drug companies influence our institutions. It happens with the media. It happens with politicians. Our former Minister of Health for the Province of Ontario heads up Rx & D now. He's a talking head for the Rx & D companies.

One of the ways they do it is to offer them jobs. Wink, wink, nod, nod, “we could use somebody like you in our organization”. For a Health Canada drug reviewer, who's overworked making $70,000, $80,000, or maybe $90,000 a year, the idea of making $150,000 from a big pharma company might seem pretty attractive. In fact, some of them do end up going over.

Those kinds of relationships are totally inappropriate.

Mr. Brian Masse: Now, you noted EPREX. What is happening in the European Parliament right now with that?

Mr. Terrence Young: Well, every country in Europe contraindicated EPREX for subcutaneous use. You can put it in your body underneath the skin. They found that for about 1 out of 5,000 people it would actually cause a reaction. They would be on kidney dialysis, basically, for the rest of their lives and unable to have a kidney transplant, so they contraindicated it.

“Contraindication”, by the way, is a very powerful word. It means you must never do this because the benefits will never outweigh the risk. A lot of doctors don't even know that. They think it only means you shouldn't do it. It's very powerful.

It's basically the law in Europe, but Health Canada, once again, is dragging their feet. I believe what's going on—and I don't know this firsthand—is the Johnson & Johnson folks are negotiating, trying to slow it down, and trying get them onside. Meanwhile, Johnson & Johnson is going to the doctors and advertising to doctors to switch all of their patients over to intravenous use of EPREX, which is apparently, by the record, safer. Once they have them all switched over to IV, they won't care if it's contraindicated for subcutaneous use. But the game is to always deny and delay.

Mr. Brian Masse: What happened in the United States on this issue?

Mr. Terrence Young: The United States has a different version of the drug, which apparently does not have the same reaction. It's not a concern to them.

Mr. Brian Masse: Okay. I'm going to ask a question of the MS Society.

I wanted to touch on your notation about access to affordable drugs. I used to work for the Association for Persons with Physical Disabilities. I worked for them on behalf of job developer persons with MS, depending on the different stages. There's an overrepresentation of persons with disabilities in this country on unemployment, and also without benefits. Unemployment is around 50% higher than anything else.

Have you talked with your members about types of specific supports? You're talking about catastrophic assistance, but what's the discussion internally about where people are in terms of their cost of living and living situations when they have to start adding different drugs and costs to their expenditures?

Mrs. Deanna Groetzinger: I'll start, and then perhaps Kris would care to add.

You're quite right in terms of the employment rate of people with disabilities being very, very low. As a society, we do not do enough to accommodate people with disabilities and train them for jobs and keep them in the workforce.

Kris, your experience is a case in point. You stayed in the workforce for as long as you could, and then you went to part-time work. But when someone leaves full-time employment, it often means their drug benefit plan is lost as well, unless they happen to have a spouse who has one. In that case, that's where the reliance on the different provincial programs kicks in. As Kris so eloquently pointed out, they vary drastically from province to province. We have some good ones and we have some bad ones.

I think the chart we provided with our brief illustrates the problem very well. That's why in the health accord and in the recommendations from Mr. Romanow we were very pleased to see the promise of trying to at least help alleviate that situation, because for people with multiple sclerosis who face the very high cost of these drugs, it is a huge problem.

¸ (1410)

Ms. Kris McDonald: One of the things I do as a volunteer for the MS Society is I field questions the MS Society receives on insurance benefits, questions like, “How can I get a drug plan?” These newly diagnosed people have employment, but they have health histories that are going to prevent them from getting any kind of long-term disability, which you really need if you have MS.

Because I'm not an apologist for the insurance industry, I am able to explain what the insurance industry does. So if someone calls the MS Society and asks about insurance, my number is given to them. I usually spend about an hour to an hour and a half with these people, figuring out what their problem is and explaining to them how they can do what they can do.

For example, if they have to fill out a questionnaire that asks medical questions, they're not going to get group insurance or long-term disability insurance, but if they work for a large enough employer with enough employees, so that the group or number of insured people would not be impacted, then the company isn't going to ask the medical questions. So I'm finding myself saying, “Go get a job with a large employer”.

My husband, for example, works for a large mutual fund company, which has 500 employees. When he went to work for them, after he took care of his probationary employment, which is usually 90 days, they just took his name, date of birth, and his spouse's name, and covered us under the group plan. They didn't ask any medical questions, so my medical history didn't become a problem. So I'm covered under a drug plan. But if you work for an employer who has 12 employees, they're going to ask you a medical question, and the minute you have to say “MS” or any other dreaded disease, which I'm sure you've heard about in your hearings, you're not going to be able to get insurance.

One of the advantages the Toronto area people with MS have is that they have me in their pocket. I'd love to go nationwide, but I don't think the world is ready for more than one of me.

Mr. Brian Masse: It's a big issue, because most employers are small, and it's extremely rare for persons with disabilities to find employment with large employers, so it's a double-edged sword.

Ms. Kris McDonald: Yes, it is.

The Chair: Thank you, Mr. Masse.

We'll now turn to Mr. Castonguay.

[Translation]

Mr. Jeannot Castonguay (Madawaska—Restigouche, Lib.): Thank you, Madam Chair, and thank you to our guests.

First of all, I must say to the Multiple Sclerosis Society of Canada that I have understood very well that it may often cost people dealing with this disease between $1,000 and $2,000 a month for drugs.

You also mentioned that you were happy to see the first ministers’ position in the February 2003 agreement, in which funds were earmarked for the exorbitant costs of drugs.

I also realize that there are people who do not have MS, but who earn less than $20,000 a year and who must pay $500 a month for drugs for other problems, such as high blood pressure, diabetes and so on.

First of all, in your opinion, what amount should these exorbitant costs be set at? Do you have any ideas in this regard, or are you more in favour of a pan-Canadian pharmacare program? A bit the way we do for our current health care, pharmacare would be there for all Canadians and would be paid for from the pan-Canadian tax system, as well. Do you think we should going in that direction rather than towards the exorbitant costs of drugs?

¸ (1415)

[English]

Mrs. Deanna Groetzinger: I think certainly moving toward a more pan-Canadian system would, in our view, be a much more sensible approach. It certainly is something that we, in our submissions to Mr. Romanow and Senator Kirby, urged be looked at very seriously. I think on the whole that would probably benefit more people.

That being said, the recommendation that was reached, and where we see things moving in the health accord, is a step forward. It is certainly better to move in that direction. It is better than the situation we have right now. We think it would benefit people. It would benefit people in Newfoundland. It would benefit people in New Brunswick right now who have very little chance of having any kind of coverage if they happen not to have that group coverage and if they are not on welfare.

We're grateful for small steps forward. In the best of all possible worlds, it would be much better for people with MS to have a much more inclusive program.

[Translation]

Mr. Jeannot Castonguay: Would you be prepared to put up with a rise in taxation to enable us to have a pan-Canadian system, realizing that if some individuals who earn $20,000 a year have to purchase $500 worth of drugs a month, this may become an exorbitant cost for them? I was trying to find out what an exorbitant cost for drugs is. When should the public system come into play?

[English]

Mrs. Deanna Groetzinger: I can only speak personally about myself as to whether or not I'd be willing to pay more taxes, and personally, I probably would. But we'd have to see how wisely the government spent that.

You're quite right. “Catastrophic” has different definitions for different income levels. I think we can look at some of the programs that are already in place in Quebec and in Ontario. There are sliding scales. I think an income-based system is probably a sensible one.

The people who have experience with the programs that work in those provinces are largely pleased with them. There are always issues around all kinds of programs, but certainly an income-based kind of approach is one that certainly I think our members would be much happier with than having the great disparities we have right now.

Mr. Terence Young: May I make a comment, Madam Chair? Thank you very much. It's a very important question.

We spend about $15 billion a year on prescription drugs in Canada, and that number is growing very fast. A lot of that money is spent on drugs that don't do anything and are unnecessary.

I'll give you some examples. They're actually marketing drugs now for shyness. They're marketing drugs for people who shop too much, as well as for hair loss, heartburn, stress, if you're tired, if you're hungry, or if you can't remember everything. A lot of money is going to drugs unnecessarily.

If we invoke the Norway rule, which is to only approve drugs that are proven to be better and safer than the drugs that are already on the market, we could save hundreds of millions of dollars and have more money for the people who truly need it.

Mr. Jeannot Castonguay: Yes, and I understand they are also working on one so that if you take too many drugs, you can take that one to cut down on the other ones.

[Translation]

I have one small question. You mentioned:

[English]

Most doctors don't read the fine print.

[Translation]

What do you suggest that we do to improve this situation? I’m very aware that when pharmaceutical companies bring out leaflets with things written in large letters and others written in very small letters, the probabilities are that the small letters will not be read.

How could we improve this situation?

¸ (1420)

[English]

Mr. Terence Young: Thank you for the question. Our first goal is an independent drug safety agency. The second is patient information leaflets to go into every patient's hand. These should be worded in plain language that people can understand and should list the dangers and the contraindications and the alternatives to the drug. It would be like having informed consent for drugs, as we have for surgery.

Mr. Jeannot Castonguay: I understand that some drug stores do that. Could that be mandatory that every drug store...?

Mr. Terence Young: Yes, but I believe it would have to be mandated and regulated and approved by an independent drug agency. The drug stores buy software to run their pharmacy, and the ones they give out now come from the States or somewhere. Some of these warnings the drug stores are handing people are actually quite dangerous, because they don't list the real dangers. They just give people a false sense of security.

For instance, when you read the one for Prepulsid that we had—I still have it at home—you just wouldn't think there was any danger. When you look at it, it says, if you have any of this, just consult your doctor. You'd think this must be pretty safe, when in fact it may not be.

Mr. Jeannot Castonguay: So basically you're saying there should be an independent agency that would provide that information.

Mr. Terence Young: Provide that information, make sure it's up to date, make sure people can understand it, and make sure all patients get it in their hands so they can judge for themselves.

By the way, in your doctor's office is a book called the Compendium of Pharmaceutical Specialties, the CPS. I have asked most people whether they have ever seen their doctor look at it. Doctors rarely do, because they think they know it all. In fact, they should be checking it for contraindications, because if you have two or three drugs in your system, you could have 100,000 contraindications once you get to three or four drugs, like many seniors. They should be checking it. But the funny thing is the drug companies even control that document. They control everything that's in it.

The only place I've seen honest, forthright information on prescription drugs is in a book called Worst Pills, Best Pills. It's by a non-profit public interest organization out of Washington called Public Citizen, co-founded by Ralph Nader. I recommend it to every family. Look in that book before you take any drugs.

Mr. Jeannot Castonguay: Thank you.

The Chair: Thank you, Mr. Castonguay.

Mr. Barrette, briefly, please. We're overtime now, so a couple of questions.

[Translation]

Mr. Gilbert Barrette (Témiscamingue, Lib.): I understand your antipathy towards the pharmaceutical companies; after what you’ve been through, that’s most understandable. What you remind us of in the way of publicity, we’ve heard in other places, and on its very face, it’s a lot.

My question may be indiscreet. How is your organization going to find funding in order to survive?

My other question is not related to that at all. If you had one recommendation to make to Health Canada to improve the situation—since there seem to be areas in which there’s room for improvement—what would it be?

As far as funding is concerned, you don’t have to answer my question, if you don’t wish to do so.

[English]

Mr. Terence Young: Thank you. I'm happy to answer.

Drug Safety Canada is in the process of being incorporated. Right now it's a few members of my family and a few people I know who are drug safety advocates. It's all funded by me right now. I would never take any money from corporations, I will tell you, and I would not take any money, if it were offered, from governments, because I think it's important that I don't. That's the way Public Citizen operates out of Washington, and I think that's very important.

To improve performance, I would just go back, sir, to an independent drug agency, arm's length from government, like the Aviation Safety Board, for instance. Planes crash and people die. You wouldn't ask Air Canada to investigate their own crashes. You have an independent board to investigate crashes and to get to the truth. We need proper patient warnings, adverse reaction reporting. I have a document I'd like to give you too, if you're interested, that lists other recommendations to make the system safer. We have a long way to go.

The Chair: Thank you, Mr. Barrette.

On behalf of the committee, may I thank you very much for coming forward, Mr. Young. With your experience as a member of the provincial Parliament of Ontario, I know you understand that government is slow. But may I say to you that actually Vanessa's death was discussed around this table on many occasions, and I think it was probably the catalyst that led this committee to select a study on prescription drugs as its topic.

We couldn't do it immediately because we had assignments from the legislature—bills to review and assignments from the minister—but the minute we had some space in our calendar where we could choose our own topic, this was the one we chose.

For those members who went on the western tour and aren't here, I want to say that I think all members of the health committee would like me to commend you for your work. Hopefully, we will be able to back you up and your recommendations. We thank you for the research you have provided, not only today, but in letters you have sent, etc.

So thank you very much to all the witnesses. Thank you for coming. This session is now over. We will ask the next set of witnesses to come to the table.

¸ (1425)

¸ (1433)

The Chair: We'll come back to order, ladies and gentlemen.

We'll move on to our next set of witnesses, beginning with the Canadian International Pharmacy Association, Andy Troszok and John Myers.

Please go ahead.

Mr. Andy Troszok (Vice-President, Standards, Canadian International Pharmacy Association): Thank you.

Good afternoon, Madam Chairperson and members of the committee. My name is Andy Troszok. I'm vice-president of standards at the Canadian International Pharmacy Association, also known as CIPA. I'm also a licensed practising pharmacist, and I own my own pharmacy.

With me is CIPA's general counsel, John Myers, and CIPA's advisor on regulatory affairs, Randy Stephanchew.

First, I would like to thank the committee for this opportunity to present CIPA's position on the provision of mail order pharmacy services by licensed Canadian pharmacists to U.S. patients. It is unfortunate that we did not have an opportunity to present when you were in Winnipeg at the beginning of October, but we will make up for that today. We have provided you with an information package explaining distance delivery of pharmacy services to international patients.

Our organization, the Canadian International Pharmacy Association, was founded in November of last year. This organization represents the interests of licensed Canadian pharmacies who are practising international services. The organization was also developed to put forth standards on distance delivery of pharmacy services, regardless of whether they are within Canada or outside of Canadian borders. CIPA has developed a certified pharmacy program similar to those recognized in the United States.

I would like to make some clarifications. This type of pharmacy practice has been called Internet pharmacy, which is a complete error. We do not support Internet pharmacy, the practice of pharmacy over the Internet, or that not requiring a physical prescription from a licensed physician. We do not support spam. We do not support non-disclosure of pharmacy information and the inability of a patient to access pharmacy services.

What we support are licensed Canadian pharmacies providing mail order prescription services to U.S. patients.

Let me take a few minutes to explain the market. The market of cross-border pharmacy has been going on for decades. U.S. patients have been driving in their cars, walking across the border, or, more recently, getting into buses and coming across the Canadian border. In one case, a senator from Minnesota has dedicated his entire salary to providing needy Americans with access to bus tours to come to Canada to get affordable life-saving medications.

Our typical customer is a senior in need. This market was not created by myself, my colleagues, or any pharmacist in Canada. This market was created because there was an unbelievable need for medications for seniors and people in need in the United States, because of the exorbitant prices being charged to the under-insured and the uninsured.

There are estimates of the depth of the market, but approximately $800 million is currently coming into Canada from sales to U.S. patients. That $800 million is staying in Canada, because these pharmacies are run by independent Canadian entrepreneurs. There are thousands of jobs being created by this industry, not only pharmacy jobs, but also technician jobs and call centre jobs, and jobs in the marketplace, especially in the areas where there is a necessity, such as Manitoba.

Currently, we are serving over 1 million consumers. There are approximately 120 pharmacies in Canada involved in providing prescriptions to U.S. patients, and 90% of those pharmacies are independent neighbourhood pharmacies, serving primarily Canadian patients, but which have developed an additional practice to U.S. patients.

What's important is, why do they need to develop an additional market? It is because the large conglomerates in this country, the large multinational chains owned by U.S. conglomerates, are driving independent pharmacy out of business. Independent pharmacy has to have the ability to compete in these markets. All we have to do is look to the U.S. market, where independent pharmacy is almost non-existent.

How do U.S. patients obtain prescriptions from Canada? First, they need a physical prescription; they need to go to see a licensed U.S. physician. When they walk out of that physician's office, they have a choice: they can walk down to the neighbourhood pharmacy; they can get a prescription through the mail order pharmacy system in the United States, which is vast and represents almost 30% of all prescriptions filled in the United States; they can come to Canada and fill their prescription through a mail order system; or they can drive up to Canada and go directly to a pharmacy.

Because we are dealing with patients at a distance, our standards and information have to be more than those you face when you walk into your regular pharmacy. Our patients are required to submit detailed health information, similar to what you would experience when walking into a doctor's office.

¸ (1435)

We gather demographic information and verify that information, medical information and medication information. We also have our patients sign a customer agreement. It is not a waiver. It does not waive our responsibility. What it actually does is enhance our responsibility. It clearly outlines that the U.S. patient will see a primary care physician in the United States. It also explains to the patients what their rights are in terms of pharmacy issues they want to bring forward.

Once we have those documents, that prescription is dispensed in a licensed Canadian pharmacy, and that pharmacy is bound by strict standards of practice set out by the provincial pharmacy regulatory bodies. Pharmacies providing international pharmacy services meet, and in some cases exceed, both provincial and federal regulations. These pharmacies have to follow a high standard of patient care and a high standard of professionalism and ethics.

I have two areas I'd like to discuss in terms of the misinformation that has been presented to this committee.

First of all, pharmacist shortages. I graduated eight years ago as a pharmacist and there were pharmacist shortages at that point. Mail order pharmacy into the United States was almost non-existent. Pharmacy growth in Canada has been exponential, especially by the large multinational pharmacy chains. Pharmacies are now offering 24-hour service, increasing the demand for pharmacists threefold. Over the past five years we have seen very aggressive recruitment by U.S. pharmacies, offering lucrative salaries to lure new pharmacy graduates south of the border, where working conditions and salaries are much higher.

There are 8,331 licensed pharmacies in Canada. Pharmacies providing U.S. patients with prescription services account for less than 1.5%. I find it hard to believe that we are responsible for the pharmacist shortage in this country.

On a positive note, we know of one mail order pharmacy in Winnipeg now servicing three rural Manitoba hospitals and looking at providing services to seven rural nursing homes. I ask here today, is one multinational chain pharmacy looking at providing needed rural services to distant and remote areas in Canada?

I refer to the issue of drug shortages. Again, eight years ago when I started as a pharmacist, there were drug shortages, and typically they were temporary drug shortages. As was presented by the evidence of the Hon. Dave Chomiak at your last session in Winnipeg, temporary shortages usually result from a problem with manufacturing, raw ingredient sourcing, or wholesale distribution difficulties. I am not aware currently of one incidence where a patient has not received a medication in Canada as a result of Canadian pharmacies providing patients with life-saving medication.

The brand-name pharmaceutical manufacturers control all of the supply of brand-name pharmaceuticals in Canada. If there's a shortage of medication in Canada and to Canadians, it is the result of the brand-name pharmaceutical companies choosing not to supply that market and protecting the monopolies they have established through patents and through exorbitant price status in the United States.

We have laws in Canada. I believe the laws in Canada will prevent these monopolies from controlling our health care and our prescriptions, through the Competition Act and through the Patent Act.

I thank you for your time and I welcome your questions.

¸ (1440)

The Chair: Thank you very much.

We'll move to the Ontario College of Pharmacists, the deputy registrar, Della Croteau, and the manager, Greg Ujiye.

Ms. Della Croteau (Deputy Registrar, Director of Programs, Ontario College of Pharmacists): Thank you for inviting the Ontario College of Pharmacists to present to the House of Commons Standing Committee on Health.

The mission of the Ontario College of Pharmacists is to regulate the practice of pharmacy through the participation of the public and the profession in accordance with the standards of practice that ensure pharmacists provide the public with quality pharmaceutical services and care.

In carrying out its objectives, the college has a duty to serve and protect the public interest. The college regulates the practice of pharmacists and pharmacies as well as the safe distribution of drugs and services in Ontario. However, the college does not regulate the daily business practices of pharmacists or pharmacies unless they have a negative impact on the public interest. The college does not regulate manufacturers or the drug approval system and will not comment on these particular processes.

We would like to comment on rising drug costs. As the population ages, utilization will increase. However, drug costs need to be considered in the context of total health care costs and quality of life for the public. We have few drugs that actually cure a disease. Most drug therapy treats symptoms and prevents further complications of chronic conditions. If one focuses on the cost of drugs and does not evaluate whether there are decreased costs to the total health care system, drug costs may appear to be disproportionately high.

Managing drug utilization through early intervention, use of guidelines for drug therapy, such as evidence-based medicine provides, focusing on patient care and outcomes and greater collaboration of health care providers will help control costs as well as provide greater accountability for the dollar spent. A collaborative practice model focusing on the patient will help to ensure better use of total health care dollars.

Monitoring of adverse effects and prescribing practices should be carried out as a quality improvement measure and should be carried out in collaboration with health care providers.

On marketing and direct-to-consumer advertising, consumers and providers should be entitled to information rather than marketing hype with respect to advertising or promotion. Results of any studies or trials, regardless of whether they have positive outcomes or not, should include full disclosure as to any bias by the person or organization presenting the data, as well as how many trials actually took place. Health care providers should be educated on analysing and understanding the study results. This would be helpful in assisting the public if confronted with questions about materials they may have heard or read.

Consumer and health professional access to drugs should not be the focus, but rather consumer and health professional access to appropriate therapy. It is the focus on drugs that's driving the costs. Our perceptions or views of drugs must be adjusted. Drugs must be considered a part of disease therapy and not the therapy itself. For example, pharmacists are trained not only to counsel patients on a lipid-lowering drug, but also to encourage positive lifestyle changes. Newer drugs may not be better. Focus should be on clinical evidence and what therapy would be best for the patient. Therapy, and even early intervention, may result in no drugs being used or no further health services required.

Misuse, abuse, and addiction among the general population. It is difficult to protect the public in these instances. Misuse, abuse, and addiction are not the same, and each situation needs to be looked at through better collaborative practices. Barriers preventing health care providers from working collaboratively really need to be examined. Pharmacist skills and services in a collaborative model have been effective in managing drug therapy and helping to prevent misuse and abuse. Also important is the creation of new treatment centres and education of health care providers in these specialized areas of abuse and addiction.

These are the comments of the Ontario College of Pharmacists to your questions. We would be pleased to answer any of your further questions, and we thank you for your attention.

¸ (1445)

The Chair: Thank you very much.

We will now go to the Pharmaceutical Advertising Advisory Board, Commissioner Mr. Ray Chepesiuk and Vice-Chair Mrs. Gloria Bowes.

Mr. Ray Chepesiuk (Commissioner, Pharmaceutical Advertising Advisory Board): Thank you.

Good afternoon. I'm Ray Chepesiuk, the commissioner of the Pharmaceutical Advertising Advisory Board, or the PAB, or the PAAB. We have many names.

I'm joined by my colleague, Gloria Bowes, who is vice-chair of PAB, representing the Canadian Association of Medical Publishers' honour board. Gloria is also an employee of the College of Family Physicians of Canada.

Back in the early 1970s there was growing government concern with misleading advertising of medicines. In response, PAB was established in 1976 as an independent, not-for-profit agency. For nearly 30 years since then, PAB has served as the advertising pre-clearance review mechanism, officially endorsed by Health Canada. All the related stakeholders are represented on PAB, ensuring our judgments are informed, balanced, and in keeping with the detailed PAB code that currently governs pharmaceutical advertising to health professionals.

Board members include representatives from three health profession associations, three pharmaceutical trade associations, the medical publishing and advertising industries, and two national consumer groups. As commissioner, I manage a staff of highly trained professionals, most of whom are experienced pharmacists, to provide efficient and effective pre-clearance service.

To give you a sense of the volume of health profession ads that we examine every year, last year we viewed over 3,200 separate advertisements, brochures, booklets, Internet ads, marketing letters, and other what are commonly called detail ads, targeting health care professionals. In addition, PAB administers a complaint resolution process.

While technically our mandate is limited to reviewing materials that target health professionals, recently Health Canada has also endorsed PAB's advisory role in the review of consumer drug advertising as it is practised today.

After nearly three decades of regulatory experience and pharmaceutical advertising, we're willing partners to be part of the future. As part of an important strategic planning exercise that PAB undertook last year, we consulted widely with governments, consumers, health professionals, and the industry. Through these consultations we reaffirmed several beliefs.

First and foremost, there remains an important need for regulatory control of drug advertising. There is a need to protect the public through the fair and efficient enforcement of regulations governing pharmaceutical advertising.

We also reaffirmed that PAB's efficiency and effectiveness in providing pre-clearance services is important to a well-regulated marketplace. We were gratified to confirm that PAB enjoys the support of governments, industry, the public, and health care professionals.

Finally, our extensive consultations reinforced our faith in the pre-clearance model that has worked well here in Canada for the last 27 years and has been adopted around the world. Unlike the U.S. model where complaints are invited after advertisements have run, pre-clearance offers Canadians superior protection. However, we also recognize that the public policy landscape is changing. PAB is committed to continuing our important regulatory role when and if the rules are reformed.

Much has changed in the last decade that bears on the DTCA debate. We know that federal and provincial governments have been encouraging Canadians to become empowered and educated patients so that we can all become true partners in our own health care decisions. Canadians have embraced this informed consumer role and are looking for health care information, often from the Internet, which has proven to be a difficult consumer medium for Health Canada to regulate.

As well, many have expressed concern with the daily onslaught of American drug advertising spilling into Canada that may be confusing Canadians, particularly when ads promote drugs that haven't been approved in Canada. In fact, you might say that we already have DTCA in Canada; it's just not made in Canada.

Finally, we're aware that the very constitutionality of the current regulations has been questioned by some stakeholders. With all of this in mind, we understand the rules governing DTCA may be changing in the future and that the Health Canada legislative renewal process may well be the vehicle of any reform.

In closing, I want to be clear about where PAB stands and where we'd like to be in the future. As a well-established independent regulatory agency, PAB doesn't make or shape policy; it enforces policy. The important message we want to leave this committee with is that whatever may emerge from this DTCA debate, it's our strong belief that the principle of pre-clearance should remain the foundation of the drug advertising regulatory regime.

As well, we have already strongly recommended to the legislative renewal process that regulatory enforcement options be improved. Further, PAB is ready to respond to any changes to the regulatory regime and to continue to provide efficient, effective, pre-clearance services on behalf of Health Canada.

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We welcome this opportunity to appear before you today, and we look forward to the discussion that follows.

I've brought you copies of the standards for drug advertising review in Canada, the PAB code, and a current copy of PAB Update in which we publicly publish complaint rulings that are available on our Internet site and available to anyone. I've also brought you copies of the overview drug advertising and Health Canada fact sheet that describes the role of PAB vis-à-vis Health Canada.

Thank you.

The Chair: Thank you very much.

Now, from the Canadian Pharmacists Association, Mr. Poston, executive director.

Mr. Poston, we've heard a lot of what the pharmacy associations do, so perhaps you could get right on to your position.

Dr. Jeff Poston (Executive Director, Canadian Pharmacists Association): Thank you, Madam Chair.

I represent the Canadian Pharmacists Association. We're the national voluntary association representing pharmacies in all areas of practice. We don't represent chain drugstores or the pharmaceutical industry. As we know, drugs are complicated. The concept of the chemical in the little pill that can kill you, save your life, or make drooping penises erect is difficult for most people to understand. Even the names are unintelligible to many people. The creation, regulation, distribution, and use of drugs is complex.

We know an awful lot about drugs. At CPHA we publish drug information--and there's a great deal of it available--and yet research continues to demonstrate problems of drug use. Results from unwanted medicines campaigns point to waste. Reviews of use indicate failure to follow treatment guidelines. Further studies point to undertreatment, patients who would benefit from drugs but who never get them. The list of studies describing failure to take medications correctly or discontinue them early continues to grow. The withdrawal of drugs from the market because of previously unrecognized adverse effects still occurs.

In simple terms we know a lot about drugs, but there's a huge gap in applying what we know to the care of patients. A number of independent reports, the Lowy inquiry in Ontario, the National Forum on Health, and more recently the Commission on the Future of Health Care in Canada, have all recognized the urgent need to make greater use of pharmacists as a key solution to improving the quality of drug use and getting better value for the money we spend on pharmaceuticals. I therefore urge governments to use pharmacies to monitor and adjust therapy in patients on long-term treatment; use pharmacists to reduce waste created by inappropriate and unnecessary prescribing; use pharmacists to educate patients to make proper use of their medication; and to detect, treat, and refer patients who are at risk because of undertreatment. Let's use pharmacists more effectively to detect and report on adverse drug events and medication errors, and to critically review, assess, and manage home-care patients with drug-related problems--and the list goes on in relation to medication management.

However, as the health care professional who is truly on the front line, the pharmacist has a broader role to play in health care. To realize this broader role, government could empower pharmacists as true primary care providers. For many patients they already are the first point of contact in the health care system. Government could also: pay pharmacists to treat simple conditions, such as seasonal allergies, and to relieve the burden on family physicians; use pharmacists to detect and refer problems such as diabetes, high cholesterol, and high blood pressure earlier; and in the area of public health, use pharmacists both as sentinels to detect problems and as messengers to allay public fears.

Why should governments use pharmacists in this way? First, they're accessible. We have over 7,500 pharmacies in community settings and some 800 in hospitals. Pharmacies are open convenient hours, and it's estimated that there are 8 million visits a day to community pharmacies in Canada.

Secondly, pharmacists have five years of university education, much devoted to the science and use of drugs, and more of this is aimed at enabling pharmacists to apply this knowledge to direct patient care. Pharmacists also have some of the strictest requirements for the maintenance of professional competence after licensure.

Third, consumer poll after consumer poll illustrates the trust the public has for pharmacists. A recent major focus group work indicates that patients are valuing pharmacists as trustworthy, knowledgeable, and above all valuable for timely personal consultation.

To make these changes happen, governments need to revise legislation and support the development of new models of pharmacy practice as a part of primary health care reform. Pharmacists have to prepare themselves for new ways of working and develop new relationships as part of the primary health care team.

As I said at the beginning, the creation, regulation, distribution, and payment for drugs is complicated, and the Canadian Pharmacists Association is very interested in and active with respect to the broader aspects of pharmaceutical policy.

So with respect to broader policy items, what should governments be doing? We would ask governments to focus on quality use and value for money and not simple crude cost control. We would also ask governments to: implement the health accord; support the common drug review process as a first step towards standards for access to drugs and possibly a national formulary; establish a national medication management centre to develop and disseminate best practices in prescribing and drug use; oppose calls for direct-to-consumer advertising; don't pursue national central bulk purchasing schemes; and avoid linking drug approval and price control into one agency. Further, governments should fund medication management programs in primary care and include drugs and pharmacist services as part of the basic bundle of services of home care.

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With respect to more topical issues, we believe government should restrict the use of medical marijuana to patients enrolled in structured trials. It should work with the United States to implement existing regulations to stop the cross-border drug trade and its potential impact on the access of Canadians to drugs and pharmacists.

Finally, we'd ask government to learn from the recent NIHB experience with respect to methadone, this being one of the worst examples of governments taking the lowest common denominator and making it a national health policy.

Thank you.

¹ (1500)

The Chair: Thank you very much.

We have one more group of pharmacists here, the Ontario Pharmacists' Association, Ruth Mallon, vice-president, and David Thomson, chief executive officer.

Ms. Ruth Mallon (Vice-President, Pharmacy Services, Ontario Pharmacists' Association): Save the best for last, I guess.

The Chair: I hope we won't hear the same thing, that's all.

Ms. Ruth Mallon: I think it will be a little bit different.

The Chair: Good. We've heard on several occasions the plea for a more active and integral role for pharmacists. We've heard that argument about six times in our travels.

Ms. Ruth Mallon: I will support that argument.

My name is Ruth Mallon and I'm the vice-president of pharmacy services at the Ontario Pharmacists' Association. With me today is David Thomson, the CEO of our organization. He's here to answer the hard questions. We are the voluntary professional association for pharmacists and we have about 5,300 members in Ontario.

The issues the committee is undertaking are of course important to our members. However, there have been many studies of late, and I trust that the standing committee reviews these so that it will avoid duplication of effort. I will only speak today of issues that are important to our members and have relevance to the mandate of the standing committee.

First, you asked us to speak on rising costs.

It is important to differentiate between drug prices and drug expenditures when we're talking about cost. With regard to drug prices, representatives from the Patented Medicine Prices Review Board will no doubt explain that prices of patented drugs in Canada have not risen highly over the last few years. Likewise, the prices of generic drugs have remained relatively stable. However, OPA is very concerned about recent developments in the pricing of pharmaceuticals.

In Ontario, pharmacists have had to bear a number of price increases within the last few years. The provincial government has not responded to these increases due to the fact that in the majority of cases the price increases are not felt by government due to the reimbursement mechanism. Therefore, pharmacies are absorbing these increases themselves. We are told that these price increases are within the range allowed by the PMPRB, but pharmacy is concerned that this situation will worsen. Already the increases are threatening the viability of community pharmacy in Ontario.

Rising prices may be related to the rise in the importation of medication from Canada to the U.S., which may be the first step for drug companies to raise prices up to U.S. levels. This is a serious situation, and the demand from the U.S. is increasing. Every day we hear of another state setting up systems whereby they are purchasing medications from Canadian sources. We urge the federal government to act before Canadian patients are faced with drug shortages and taxpayers with higher drug bills.

With regard to drug expenditures, we are aware that in both the private and public sectors expenditures are rising in the range of 11% to 20%. This is true across all provinces and internationally as well. Some of the reasons for increased expenditures include the availability of new drugs for prevention of disease. For example, there are drugs that prevent kidney problems in diabetics. There is increased availability of drugs to treat diseases where we never had drugs before, such as drugs used for Alzheimer's and multiple sclerosis.

With an aging population, we can only anticipate that drug expenditures will continue to rise. This alone is not a bad thing, as one would argue that we are investing today to prevent expensive treatment in the future. Unfortunately, health care is often funded in silos. The hospitals discharge patients early on medications and patients are treated by home-care nurses. Hospitals save money, but community care and drug budgets are strained. Medications that keep patients out of emergency rooms provide no savings to employers.

The message here is that we caution the committee not to simply focus on the drug budget without looking at cost avoidances in other areas of the health system.

Rising drug expenditures are placing enormous pressures on taxpayers and employers alike. In response, drug benefit plan managers have incorporated a number of mechanisms in an attempt to reduce expenditures. Unfortunately, none have managed to wrestle the growth significantly, and the institution of these mechanisms has had unanticipated impacts on health care professionals. Pharmacies are bearing a tremendous administrative burden of these mechanisms in an environment where there is a shortage of pharmacists and, more important, a need for pharmacists to be even more vigilant about monitoring drug use, not for making sure that appropriate insurance forms are completed.

OPA urges the committee to investigate ways to improve drug research. Generally, when a new medication comes to the market the manufacturer has completed studies comparing the effectiveness of the drug with placebos or no treatment at all. It would be beneficial to practitioners for a new drug to be objectively compared with the other drugs currently available for treatment of a disease.

I will end with the most important message that I wish to leave you today--and through respect for time, I did leave my brief here--which is basically to support pharmacists. Our Ontario government is working toward supporting pharmacists in medication management roles. But one of the things we need in order for that to happen in a collaborative way is access to patient information in the community setting. Pharmacists who work in hospitals and long-term care are making significant in-roads in patient care, and they have access to a significant amount of information that community pharmacists don't have.

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One way to make this happen is through the use of information technology. The government needs to invest in systems that will allow the sharing of this information to provide for efficiencies and to improve access to vital information that will give all health care professionals the ability to optimize care.

Thank you.

The Chair: Thank you very much.

We'll now start the questions and answers, and we'll begin with Mr. Ménard.

[Translation]

Mr. Réal Ménard: I’m going to ask five questions, so I’d like some short and to-the-point answers.

The testimonies given by pharmacists’ associations contrast a bit with the consumers’ interests presented to us. My first question is addressed to you, Ms. Mallon. The link you establish between the export of drugs to the U.S. and the cost of drugs does not seem obvious to me. I’d like you to demonstrate this to me.

Second, you said that the pharmacists absorb a share of the increase in the cost of drugs, which doesn’t seem obvious to me either. You know that we have received many witnesses. When we try to understand the rise in the cost of drugs in terms of percentages, we’re told that 65% of the increase in the costs of drugs comes from the manufacturer, 30% goes to the pharmacist and 5% to the wholesaler. I’d like you to explain to us quickly, in three minutes, the link between the export of drugs and their cost, and to tell us how pharmacists can absorb a share of the cost of drugs, when theoretically this is a regulated program.

I will then have three other questions, but which are not for you.

[English]

Ms. Ruth Mallon: We've been approached by pharmaceutical companies asking us not to support international mail order. They talk about the pressure on them from their head offices to raise price increases in Canada in order to try to stop that from happening. I don't have proof that there's a direct link, but it's happening more and more, and it's happened in the last five years, starting with one simple drug. Now we have 300 or 400 drugs with price increases.

This would be an Ontario issue. The reason pharmacists are absorbing this cost is the way we are reimbursed through drug plans and through our Ontario drug benefit program, our pharmacare program, and there's a tolerance in the reimbursement to us of up to 10%.

They have a published formulary. They say $10 is what we'll pay you plus a 10% markup, so that's $11. But the pharmacist isn't buying it for $10. The pharmacist is buying it for $10.99, so he's making a penny. Then we can charge only a flat dispensing fee. That's why the pharmacist is absorbing those costs. That 10% used to be profit. Now it's going to the drug company or the wholesalers.

¹ (1510)

[Translation]

Mr. Réal Ménard: All right, thank you.

My questions are now for the Pharmaceutical Advertising Advisory Board. I’m very happy to know that you exist, but at the same time, I have the impression that you have been emasculated as far as your powers are concerned, in that I gather your role is more of an advisory one. You know that many testimonies made before the committee stated that the Food and Drug Act, which governs the main provisions respecting advertising related to health professionals or consumers, is breached. We began our hearing with a copy of the journal of the Canadian Cancer Society, displaying an advertisement for a product, when this is illegal.

So I ask you the following question. Do you have the means to apply your policies or are you limited simply to an advisory role, without any coercive tools or capacity?

[English]

Mr. Ray Chepesiuk: First and foremost, we're mainly an advisory body. But we have a relationship and a policy with Health Canada, and any issues that involve patient safety, complaints that come in or allegations of patient safety regarding drug use or drug promotion, we send to Health Canada for enforcement immediately. We don't rule on them.

We mainly handle trade disputes. Also, any issues regarding pre-notice of compliance, before a drug has been approved for marketing in Canada, we pass on to Health Canada, as well as complaints about direct-to-consumer advertising.

So we have a working relationship with Health Canada as far as enforcement is concerned. We will take first steps, and we do have, as I mentioned, a complaint resolution process by which we will take first steps to achieve correction.

Mr. Réal Ménard: My question was, what powers do you have?

[Translation]

If someone breaks the law, what powers do you have?

[English]

Mr. Ray Chepesiuk: We issue penalties as a first step--stop and destroy material, recall material. We have companies issue correction letters. We had four of those last year. To my knowledge, Health Canada has requested zero in the same time period.

Companies generally comply. If they don't comply...our power is to lodge the complaint with Health Canada, asking for enforcement. Health Canada has ultimate authority for drug advertising regulation in Canada. We act as an agency to ensure the day-to-day monitoring and enforcement, where possible, and we advise as to what the regulations are.

[Translation]

Mr. Réal Ménard: Thank you.

With regard to the pharmaceutical industry as a whole, I think there are a lot of MPs around this table who are concerned about the type of influence-peddling done by certain pharmaceutical companies, particularly the innovative ones, among health professionals, of which you are one. One of the forms of this influence-peddling is the whole issue of gifts and samples.

Are you aware that some of your members receive samples and gifts, and are there any links to be made with the prescription of certain products? Don’t you think that there should be a code of ethics or even a record of mandatory statements of samples circulated by pharmaceutical companies?

I could perhaps address my question to the very voluble Ms. Mallon first and then ask others to answer it.

[English]

Ms. Ruth Mallon: He is talking about innovative pharmaceutical companies providing gifts or samples. We've always supported the position that the process of sampling could potentially harm patient care because pharmacists would then have no record of that sample being delivered to the patient. I think there are alternative ways to provide free samples to patients. There are some enterprising entrepreneurs who are actually doing that in eastern Canada.

[Translation]

Mr. Réal Ménard: But are you informed by one or another of your associations, Ms. Croteau, Ms. Mallon or the others, that this practice is widespread? Are you concerned about it? And are you seeking legislative or regulatory intervention?

¹ (1515)

[English]

The Chair: Mr. Thomson.

Mr. David Thomson (Chief Executive Officer, Ontario Pharmacists' Association): Thank you, Madam Chair.

First of all, let me clarify. The issue of samples is about a doctor's office providing samples to a patient.

But on the issue of professional allowances across the country, professional allowances have emerged to represent a significant source of revenue for pharmacists and pharmacy in Ontario and across the country. It is a normal business practice. It is required to be reported through income tax.

But let me explain part of that. How does that money get used? A lot of it gets used in providing enhanced patient care. I'll give you an example, and this is a real-life case. A 70-year-old walks into a doctor's office in a small town in Ontario. They've just lost a physician to a heart attack. There are 4,200 new patients now in that city; the doctors are heavily pressed with work. They send him to a pharmacy. He's just been diagnosed, for example, with diabetes, and he has to have glucose monitoring and all of that. The pharmacist may spend upwards of 45 minutes to an hour counselling that poor individual, who's kind of shocked--he's diabetic; he has to prick his finger to take blood glucose. What does he get paid for that in Ontario? He gets $6.54.

So what we have seen is that the professional allowances have increasingly been used by pharmacy to pay for those counselling services. And those are documented cases.

[Translation]

Mr. Réal Ménard: You think that there aren’t any samples circulating among pharmacists and that only physicians, as health professionals, receive samples? You think that pharmacists do not receive any?

[English]

Dr. Jeff Poston: On the issue of samples, or, as the industry would call them, clinical evaluation packages, they are pretty much given to physicians. There is, as I understand it, very limited sampling to pharmacists of some non-prescription medication, but there's no sampling to pharmacists of prescription medication.

But the issue is, we've tried to work with the industry on a number of occasions to actually develop alternatives to existing sampling programs. Where it always sticks is in the fact that physicians use industry samples to provide medication to people who are not covered by drug benefit plans. The defence the industry has when we attack them on it, the defence that physicians have when we attack them on it, is they say it's the only mechanism they have available to them to make drugs available to people who have no drug benefit schemes and can't afford medication.

We've developed and worked on developing voucher programs, and with electronic online claims processing we think there are schemes that could be developed as an alternative to current sampling programs. As my colleague from Ontario mentioned, there are some experimental schemes going on, but it hasn't become a large national program.

[Translation]

Mr. Réal Ménard: Thank you.

[English]

The Chair: Thank you very much.

Mr. Barrette.

[Translation]

Mr. Gilbert Barrette: Thank you, Madam Chair.

Hello. I’ve got two or three little questions. With regard to advertising, from what I see at present, as an ordinary citizen, there’s a lot of promotion. It’s called information, but to my mind, it’s much more partisan advertising, since something’s being sold.

How can you intervene in this regard to ensure the protection of citizens? We saw some this morning and we can see some every day.

[English]

Mr. Ray Chepesiuk: First of all, we help regulate advertising, and advertising is defined in the Food and Drugs Act, in legislation. It's a legal entity, and we have to be careful about our mandate and where we can go.

Information is technically not regulated by law. That's a problem Health Canada has as well. We have sent complaints to Health Canada, and Health Canada has responded that this is not advertising, it is information, so they won't take action. Now it is a very tricky picture, very complicated as far as what is advertising and what isn't in terms of the legal definition. But basically the definition in the Food and Drugs Act is any means whatsoever for promoting the sale of a product. Technically, if you believe that somebody is trying to sell you a product, that is advertising. That's one of the messages we convey to companies when they try to define a line of what is advertising and what is not. And companies do this frequently, because they know from a legislative point of view that “information” is not regulated. So it's a difficult picture.

If you're talking about consumer advertising, that is technically not within the mandate of the Pharmaceutical Advertising Advisory Board--not yet--but it's within the mandate of Health Canada.

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The Vice-Chair (Mr. Réal Ménard): I think Jeff wants to add something.

Dr. Jeff Poston: It's a very good question in terms of the difference between promotion and information.

One of the things, to be fair to Health Canada, is they're developing new requirements for their product monographs. As an association, we actually published the CPS that was mentioned earlier. The content in the CPS is the officially approved product monographs from Health Canada. They're actually going to be requiring manufacturers to develop patient information pieces that are going to go into that. So I think we will have some standardized patient information available.

But what it comes down to is there's no magic solution here. The patients have to talk to their pharmacist and their physician about their condition, because generalizing information is really quite dangerous. There really is no substitution for patients having good discussions with their physician and with their pharmacist about their drug treatment and what's going to work for them. At the end of the day, for drug therapy to work it has to be particularized to meet the needs of the individual patients, and the only way that's going to get done is by health care professionals being involved in doing it.

The Vice-Chair (Mr. Réal Ménard): Do you have another question?

[Translation]

Mr. Gilbert Barrette: Yes, please.

With regard to advertising, some research indicates that there are more dollars spent on advertising than on drug research. This worries me a lot and I think I’m not alone. This is an observation.

I have trouble reconciling the role of the pharmacist, who may be both consultant and consulted, and the role of the virtual pharmacist, as I call it, that is, the Internet pharmacist. Is there not a risk of over-consumption or a risk that a prescription may be issued without there being any discussion? The Internet is also on-line. Both Mr. Poston and Mr. Thomson have mentioned that the pharmacist’s role is to consult and discuss with the patient. Surely Mr. Troszok can answer this question.

[English]

Mr. Andy Troszok: Yes, I'll answer that question.

I agree with you 100% that pharmacy organizations on the Internet that do not provide access to physicians or to pharmacists are, in my mind, illegal, illegitimate, unprofessional, and should not exist. That is not the industry that we represent. We represent mail order pharmacy, licensed Canadian pharmacies. Each one of our patients is phoned and offered the opportunity to speak with a pharmacist to provide counselling on maintenance chronic medications. Our pharmacists work with both U.S. pharmacies and U.S. physicians to provide a continuity of care. We do not deal in narcotics. We do not deal in acute medications. We deal with maintenance chronic life-saving medications. Our patients have a 1-800 number they can call at any point and speak with a pharmacist.

Fundamentally, I presented this year at the CPHA conference in Vancouver and I showed the CPHA some of the innovative techniques our pharmacists are using to communicate patient care in the comfort and the privacy of their own home. We feel this is cutting-edge technology on how pharmacies can provide care.

[Translation]

The Vice-Chair (Mr. Réal Ménard): Is there another question?

Mr. Gilbert Barrette: I’m just trying to get a better understanding. In your document, you mentioned that they no longer need to travel by bus, that you go to fill their prescriptions and that they can do it on-line.

¹ (1525)

[English]

Mr. Andy Troszok: The online system is only for advertising a pharmacy. Just like pharmacy organizations here in Canada use the Internet to advertise—Shoppers Drug Mart does it all the time—we use the Internet to advertise, and people can submit their personal information online.

Again, the Internet is such a small component of our practice. It is mail-order, distance-based pharmacy. Patient care is a priority, and we do provide it. In my argument, I would probably say we provide it to as high a level as any average pharmacy in Canada, if not higher.

[Translation]

The Vice-Chair (Mr. Réal Ménard): Have you got any other questions? That concludes your intervention.

[English]

Mr. Brian Masse: Thank you, Mr. Chair.

I'd like to ask the first question of the Pharmaceutical Advertising Advisory Board. What percentage of things that you send to Health Canada do they actually take action on in terms of your recommendations? Do you do any statistics in terms of warnings or complaints, and the actions they take?

Mr. Ray Chepesiuk: The actions that Health Canada takes. I think someone earlier in the afternoon described the Health Canada process as being a bit of a black hole.

We've been working on improving communications to get feedback from Health Canada. In the past we would send a complaint to Health Canada and never hear what happened at the end. We wouldn't get the results. Within the past year, we've been getting letters back from compliance officers indicating what action has been taken. It's not prompt.

We have a 15-day timeline as far as acting on complaints. I've been commissioner for five years, and I've referred three cases of non-compliance with the PAAB ruling to Health Canada where we've asked for their intervention. We've sent other complaints about direct-to-consumer advertising and Internet advertising and pre-notes of compliance advertising.

I'll give you a recent example. On October 15 I had a letter back from a compliance officer in Health Canada saying that they had received appropriate action, corrective action from the company. I had sent that complaint to Health Canada on January 10, 2003. It's not unusual for two months to pass. I've had another direct-to-consumer advertising case that took a year. I received a letter and I had no idea what it was about, because I'd sent the request a year ago.

I believe that the PAAB is not 100% perfect, but working in tandem with Health Canada, if Health Canada is the brick wall behind PAAB, we can help resolve most of the cases.

I don't know if you're aware that currently in the regulations the fine for misleading advertising in the Food and Drugs Act is $5,000 or a jail sentence. Those are the choices. Those are the options. If Health Canada acts to enforce, they have to take someone to court in a legal manner. It's a legal process.

Our process is not based in law. We have flexibility and alternative action. Public reporting, quite frankly, is one of the worst penalties. If you make their actions public, companies don't really appreciate that. It's not good for future business.

I understand that through the legislative renewal process enforcement is one of the areas Health Canada is looking at. We've been consulted on alternative complaint resolution—how to bring about penalties or degrees of penalties. I think that's missing in the system right now. It's all or nothing.

Mr. Brian Masse: It sounds to me like your organization needs birth more than renewal.

If I could follow up, I'd ask who funds your organization, or how do you manage your...?

Mr. Ray Chepesiuk: It's funded on a fee-per-service basis. We give advisory opinions and the companies or clients basically pay a fee. We have a fee schedule for each review. We also have fees for opinions. We also do training sessions with companies and we charge a fee for those training sessions.

Mr. Brian Masse: Wouldn't it be more advantageous to have a publicly funded or independent body? It would seem there's an inherent conflict there. I go to you to get an opinion on my ad and I pay for that. You're dependent as well on that process for your revenue.

Mr. Ray Chepesiuk: But keep in mind that Health Canada endorses the process, and without that endorsement, they can pull the plug. Our organization wouldn't exist. If they don't endorse the process, nobody would come to us. It would be free game.

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Dr. Jeff Poston: I have a comment on that. I think you'll remember that advertising is only one of the sources family physicians and pharmacists have access to when it comes to making decisions about prescribing.

A very important part of medication management programs that have been developed in Canada is this concept of academic detailing, where pharmacists get used--in some cases it has been trained nurses--to help physicians prescribe in accordance with clinical practice guidelines.

What we've really been calling for in our submission is that part of the money that is in the health reform fund should be invested in developing medication management programs so health care professionals can be assisted in making better decisions about drug therapy, rather than relying on advertising as a key source of information in decision-making.

Mr. Brian Masse: One quick question, Mr. Chair. I also apologize, but I have to leave after this.

To the Canadian International Pharmacy Association, there has been the charge that pharmacists are in short supply. You note it in your presentation. You were saying there was always a shortage. What can we do to shore up that situation so there are employment opportunities?

Secondly, I guess to at least hear your side of the story, what can we do about the fears that seem to be spread out there related to Canada not being able to receive proper medications because of the services being provided through mail order or Internet pharmacy?

Mr. Andy Troszok: I can answer that question. The first thing I think we can look at is pharmacy efficiencies. One thing we've been able to provide through our mail order services is to actually mirror our mail order services behind what some hospitals are doing--basically, central fill facilities.

We remove pharmacists from the technical role of counting and dispensing pills and put them into clinical roles where they're either doing verifications or calling patients. Steve Long, head of Calgary Regional Health Authority's hospital services, has just removed 32 pharmacists from dispensing functionalities and put them on wards to work with doctors. We are following a very similar level of process.

I met with Gary Mar, Alberta's health minister. He asked, “What can you do for our province? I don't really care what you're doing with the Americans, I want to know what you're doing with us.” What we're considering is how we can provide maintenance medication services to remote areas in Alberta--Canada as well--and how we can work with larger organizations to create efficiencies.

Pharmacy has been continuously criticized about people going to school for five years, as Jeff Poston mentioned, then coming out and counting pills. This process is not changing. Pharmacies opening up for 24 hours are increasing the demand for pharmacy services. I think we really need to reassess that. I think we need to put pharmacists in better positions.

I also think we need to offer pharmacists opportunities. There are statistics that show that after five years in practice, approximately 30% to 40% of pharmacists leave community-based pharmacies. Why are they leaving community-based pharmacies? Is it the working conditions? Is it the fact that non-pharmacists own the companies and dictate what pharmacists are going to do, the fact that pharmacists are practising in big-chain organizations where pharmacy is the least important department in that store?

There are many reasons. I think we have to be innovative, we have to be creative. When pharmacists come up with innovative ideas for practice, they cannot be stifled. They cannot be stifled because large multinational corporations say “This is wrong and it's infringing on our profits”.

To answer your second question, that's our bottom line. As was mentioned by Ruth, she's getting drug companies coming to her and saying “This had better stop, or we're going to raise prices”. I think our integrity in Canada with our pricing policy, with our negotiations, with our Patented Medicine Prices Review Board, we have to stand behind that. If we look at what happened in Europe 15 years ago with parallel importation, there are examples of how this system can work and be beneficial to all involved.

[Translation]

The Vice-Chair (Mr. Réal Ménard): Thank you. That concludes the discussion with our NDP colleague. We give the floor now to Ms. Brown.

[English]

Ms. Bonnie Brown: Thank you very much.

I have this feeling that I'm Alice in Wonderland or something, because I keep hearing from witnesses what is supposed to be really bad news: it's really bad news today that there are a lot more new pharmacy jobs in Canada; it's really bad news that Americans want to buy Canadian products; and it's really bad news that our balance of trade will be favourably affected.

I guess the only reason I can hear that it's really bad news is the fact that multinationals, which control the supply of pharmaceutical products in this country, must be threatening us or something. They're threatening us by saying that Canadians won't have enough drugs if we keep this up.

Now why would they do that? Why would any company not want to sell more product?

They see it as selling the same amount of product in Canada at a regulated price, rather than selling it in the United States at an unregulated price. Instead of selling a pill for 80¢ in Canada, they want to sell it to the United States at a dollar.

Then we think of our international obligations--not that I feel totally responsible for American citizens, but the fact of the matter is, they are having a problem that is of their own making. They don't regulate the price of pharmaceuticals. They have people who have no coverage at all--as we do, but they have many more. Here these poor people have a chance to get a drug at a price they might be able to afford.

Now the multinationals are threatening us, much as they did with South Africa when they weren't going to supply AIDS drugs and were going to take South Africa to court. I don't know why we're even considering giving in to this threat.

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Dr. Jeff Poston: If I could answer that, I think the issue here is, if we had a situation in any of the provinces that you come from where 20% of the physicians were being used to serve U.S. patients and were not serving Canadian patients, I think you'd see it in a different way.

Ms. Bonnie Brown: I was in Manitoba, and they didn't tell me anything about 20% of physicians.

Dr. Jeff Poston: I think the data is that 20% of pharmacists in Manitoba are involved pretty exclusively in the provision of international prescription services to the United States.

You could take that argument and apply it across the board. Should we be going into the business of export in our health care system to the United States? The problem there would be that we would be depriving Canadian citizens of services.

You mentioned our international obligations. One of the challenges that we have here is that the drug regulatory process and the drug pricing systems are set up on a national basis. We haven't been able to grapple yet with the transparency, to a certain extent, that the Internet has created around drug prices. It means that we don't have mechanisms in place to deal with a global pharmaceutical market. We still work in isolated national markets with national schemes to regulate drugs for the benefit of our citizens and national schemes to actually control and regulate prices.

With that sort of situation, if you have parallel trade, its interesting that Mr. Troszok talks about parallel trade as a problem in Europe.

The Fraser Institute report—and I'm no great fan of the Fraser Institute—was very interesting in some of the issues that it raised about how parallel trade was a problem, but they raised the issue that, again, it's an international obligations issue around NAFTA.

Is the parallel trade that's essentially going on with the U.S at the moment an infringement of NAFTA? What are our obligations under that?

Ms. Bonnie Brown: I thought NAFTA was supposed to allow for this sort of thing. You can be sure that if there was a price of anything that was cheaper in the United States, and Canadians were driving over there to pick it up or sending in an order and asking for it to be sent by mail to Canada, there would not be any kind of an uproar by the Americans or by us.

Dr. Jeff Poston: The other part of the equation with that is their argument. You have to say—I think this is what I would say—that their allegation has to be investigated because they quote a clause in NAFTA around intellectual property protection, which they will argue the parallel trade violates.

I'm not here to defend the Fraser Institute.

Ms. Bonnie Brown: I'd like to hear Mr. Troszok or Mr. Myers respond to my questions and your intervention.

Mr. Andy Troszok: Well, I think the questions that you raised are exactly the same questions that we raised. It's why we feel we are providing a valid service to U.S. patients.

What I want to challenge is this notion of 20%. I've stated that there are 8,300 licensed pharmacies in Canada of which 120 are doing this business and 90% are doing both domestic and international business. I don't have a clue where 20% of our resources are going to support this kind of practice.

What it's actually doing is making independent pharmacists, who have been struggling to survive and struggling to provide some of the clinical services to Canadian patients, now all of a sudden being able to compete with multinational pharmacies and thriving within urban communities and within rural communities.

Mr. Poston, I would like to see the evidence of 20% of either physicians or pharmacists focusing on international prescription services. There is no evidence of that.

¹ (1540)

Ms. Bonnie Brown: Thank you very much.

I have a couple of questions. I don't understand how Mr. Chepesiuk can say that the pre-clearance of ads works well, when pre-clearance is not mandatory. If in fact people post ads in magazines or newsletters, ads that you haven't pre-cleared because they haven't brought them forward, no one knows about this unless someone complains. Seeing that every panel we've had before us, other than maybe this one, doesn't know that you can complain about pharmaceutical ads that break the rules, no one complains.

Therefore, you also said that you enforce policy. I'm not saying you're not doing a good job within the parameters you're given, believe me. I know you are, but you can't enforce policy if you don't have any mechanism for sanctions. Our understanding from Health Canada is they try to elicit compliance, as opposed to enforce by sanction.

Mr. Ray Chepesiuk: That's the point I was raising earlier, that we've actually asked Health Canada, through the legislative renewal process, to improve enforcement from a regulatory and legislative basis.

Right now, Health Canada, quite frankly, is fairly weak in its ability to assess meaningful penalties. We assess penalties, in that companies cease and desist. And there's a cost to destroying materials and a cost to sending out correction letters.

Ms. Bonnie Brown: But considering the deep pockets these pharmaceutical companies have, the fact that they can get an ad in the paper for a week.... How about the insert in the Globe and Mail that the previous witness brought?

Mr. Ray Chepesiuk: Can I just correct something? We don't review advertising to consumers. That's sometimes a misconception when people say they don't know where to complain.

Our reviews are for advertising targeted to health professionals. That's our mandate.

Ms. Bonnie Brown: Oh, that was not explained to us. They suggested that it was any kind of advertising. So what they're saying is you're supposed to pre-clear ads to professionals, but they can advertise, or give these reminder ads, to the public without any pre-clearance.

Mr. Ray Chepesiuk: There's no mandated pre-clearance in any codes; it's not within our code.

Ms. Bonnie Brown: Were you here for Mr. Young's presentation?

Mr. Ray Chepesiuk: Yes.

Ms. Bonnie Brown: Considering what we heard from him, he encapsulated rather well the testimony we've heard across the country. Somebody might have made two of his points, and someone else made two others, but he put it together in a package because he's been working on it seriously.

Do you think the ads that you see really add very much, in a totally unbiased way, to the information that consumers have, or do you think that they'd be better off with a piece of paper given to them by the pharmacist at the time of the dispensing of the prescription?

I can't see what these ads do except get people excited.

Mr. Ray Chepesiuk: I want to be clear. Are you talking about advertising to consumers or advertising to health professionals? They're very distinct entities.

Ms. Bonnie Brown: Of course we're concerned about both kinds, but the issue before us right now is direct-to-consumer advertising.

I had no idea, even when you were speaking, that you only pre-clear ads to professionals. Health Canada gave us the impression that you were pre-clearing all ads.

Mr. Ray Chepesiuk: It's not true.

Ms. Bonnie Brown: That's what they said.

Is that how you understood it, Mr. Chairman?

Mr. Ray Chepesiuk: We provide advice on direct-to-consumer advertising, which Health Canada recently asked us to do.

Quite frankly, in 1996 they had a consulting workshop to look at direct-to-consumer advertising, and nothing has changed as far as legislation is concerned since that time. What has changed is the marketplace.

Ms. Bonnie Brown: Do you think professionals need to receive ads in their magazines, or is it just the fees that keep their magazines alive?

¹ (1545)

Mr. Ray Chepesiuk: No, from a point of view of the advertiser, advertising is biased.

Ms. Bonnie Brown: Exactly.

Mr. Ray Chepesiuk: That's inherently what advertising is.

But advertising is the best source of creating awareness. If it wasn't, why do I see “Canada” signs? The Government of Canada uses advertising quite extensively. I was in the SkyDome watching a baseball game, and there was a “Canada” sign on the right-field fence. I'm sitting there and thinking, why are they selling the Government of Canada to me while I'm watching a baseball game? But what that does is to create awareness that somebody is there doing something for you. I presume that's why the Government of Canada advertises.

In the same way, drug companies create awareness through the fact that their products exist, and they provide enough information that there's a benefit. We can show you some advertising that has fair balance information, as far as safety information is concerned, accompanying it. That's one of the roles we play through the pre-clearance mechanism, to ensure there's enough fair balance in the ad.

The Vice-Chair (Mr. Réal Ménard): Your last question.

Ms. Bonnie Brown: It won't be a question, just a comment to you, Mr. Chairman.

It seems to me, first of all, that we have not had a clear picture from Health Canada. They implied that pre-clearance of ads had to do with all advertising, not just advertising to professionals.

There's the whole question of raising awareness, which might be one thing, but certainly according to most of the witnesses we have heard, the advertising is biased and does not give you a clear picture. The advertising we have found in magazines does not give you a clear picture; it's not information, but is simply to add to profits.

Thank you, Mr. Chair.

The Vice-Chair (Mr. Réal Ménard): I think we have to re-invite Health Canada to appear in front of us.

Ms. Bonnie Brown: Absolutely.

[Translation]

The Vice-Chair (Mr. Réal Ménard): Mr. Castonguay, you may ask one final question, please.

Mr. Jeannot Castonguay: Thank you very much, Mr. Vice-Chair. Once again, your presence here is very important for us.

Ms. Croteau, you told us that perhaps too much emphasis was placed on access to drugs and that we should place more emphasis on access to the appropriate treatments. I think that your point is well taken and I thank you for having made this distinction to the committee; we will certainly take it into account now.

You also talked about the importance of greater cooperation among health professionals. We hear that quite often. Personally, I believe in the importance of a team approach to health care. From a practical point of view, however, how do we go about it? How do we go about getting greater cooperation among the various professions? Very often among the individuals in different professions, there seems to be a kind of local practical understanding—I myself am a physician and I see that regularly—, but when the professions talk to one another, it seems there are obstacles to this getting off the ground.

Do you have any suggestions to make in this connection? What are you doing here, in Ontario, about this? Do you have discussions with the medical association or the nursing association or other health professionals’ associations? In the Canadian government, what can we do to promote this sort of cooperation? I don’t think this can be legislated, unless you suggest that we take such an approach. I’d like to hear what you have to say.

The Vice-Chair (Mr. Réal Ménard): Who is your question for, Mr. Castonguay?

Mr. Jeannot Castonguay: For Ms. Croteau, Mr. Vice-Chair.

[English]

Ms. Della Croteau: Yes, I think this is a problem that needs to start right at our educational level. If we as pharmacists, nurses, and doctors are working together in our training period, and see the roles of the other health professionals, and learn to work in a collaborative model right from the beginning, then we can take that out to communities.

One of the things I deal with because we're an Ontario regulatory body--and I believe it's the same way in every province--is that we all have a particular scope of practice and particular controlled acts. Unfortunately, we fight each other over “That's my job, and that's your job”, rather than saying “What's the best thing for the patient, and who can provide that?”

Often pharmacists are scrambling to get a prescription from a doctor, because that's the system we have, and in order to do it legally, you must get a prescription from a doctor. Is there a way pharmacists could provide some initial prescription, working collaboratively with the doctor? We can't have different health professionals giving patients different prescriptions. We really have to keep it all together for the patient so that we have one health record and we can all have access to that health record.

So it's a difficult model to develop in a community. If you have a small community it works well. In the city of Toronto, it's more of a challenge because you could be filling a prescription from a doctor from one of the downtown teaching hospitals and you live in Oakville, and creating that collaborative model is more difficult.

I believe a lot of the front-line practitioners could provide some of that care, but it's really important that we keep informing the other health care practitioners of what's going on. The new health legislation is trying to address that. So we have fewer silos than we used to, but we still have those silos, and we still have scopes of practice that are butting up against each other and we're fighting each other about it instead of asking, how can we work together to provide care for the patient?

¹ (1550)

[Translation]

Mr. Jeannot Castonguay: I’m very aware that this obviously requires a change of culture regarding each of our respective associations. At present, from a practical point of view, do you see any discussions? Is it on the radar screen of the various associations? We’d at least have to talk to one another and agree so that the client, the Canadian who needs care, was at the centre of our interests. We all claim to be there for the patient, but from a practical point of view, I’m not sure that our associations... I’d like to find out whether the associations are talking about it.

As an individual, very often, in a one-on-one context, I could talk with the pharmacist or the nurse, and we made little agreements together, since we were working towards the same goal, not to get in each other’s way and exchange information. But at the association level, are there discussions?

My question is addressed to whoever wants to answer it.

[English]

Dr. Jeff Poston: With the Canadian Medical Association and the Canadian Pharmacists Association, we actually have a joint statement relating to optimal drug therapy. It's about five years old now, and we're talking about revising that, because it does look at the respective roles of pharmacists and physicians with respect to optimal drug therapy.

To some extent, we're looking at the need to update it and revise it as we're going to address the issue that has been raised with the development of the primary health care team. We see that, as Ms. Croteau was saying, as something to do in the future.

The other area with respect to which we've just started discussion with the Canadian Medical Association is electronic prescribing and how we are going to harness information technology to really, hopefully, address a lot of the problems the committee has heard about: the need to get information on new side effects and new adverse effects to physicians and pharmacists quickly, and the need to be able to share information so that patients get better care.

So we think information technology has a lot to offer, and we are certainly starting those discussions with medicine at the national association level. But certainly more work needs to be done at the provincial level as well.

Mr. Jeannot Castonguay: Is there anything that we, as a committee, could recommend to Health Canada or to the Government of Canada to help in that direction?

Dr. Jeff Poston: The direction, to a certain extent, with respect to the development of primary health care teams and the health accord is the important sort of first step. I think there is a policy framework within the health accord, and there is certainly some funding in which it can be moved forward. So I think the important thing is to really encourage governments to support, implement, and work on the health accord. We do have that framework in place.

[Translation]

The Vice-Chair (Mr. Réal Ménard): Mr. Castonguay, is it all right with you if we stop here, or do you want to ask another question?

Mr. Jeannot Castonguay: No, thank you. I’m going to respect your direction, Mr. Vice-Chair.

The Vice-Chair (Mr. Réal Ménard): You are a man who is both charming and understanding.

[English]

I would like to thank each of you for appearing before the committee. You will receive a copy of the report when our chairman tables it in the House of Commons. Thank you very much.

I'll suspend for several minutes.

¹ (1555)

º (1613)

The Chair: I'll call this session to order and welcome the representatives from the Ontario Ministry of Health and Long-Term Care: the assistant deputy minister in the health services division, Mr. David McCutcheon; and Susan Paetkau, the director of the drug programs branch.

The floor is yours.

Dr. David McCutcheon (Assistant Deputy Minister, Health Services Division, Ontario Ministry of Health and Long-Term Care): cThank you very much for the invitation to speak with you today. It's indeed a privilege for us to be able to share some of the issues we face as the Ontario drug benefit program within the Ministry of Health for Ontario.

What we'll do is go through our presentation, and then we'd be very pleased to take the questions of the panel. I'll ask Susan Paetkau to lead off on the presentation.

Ms. Susan Paetkau (Director, Drug Programs Branch, Ontario Ministry of Health and Long-Term Care): Good afternoon.

Ontario drug benefit actually covers about 20% of the Ontario population, although we pay a little under half of the prescription costs in Ontario. We cover all seniors, people receiving home care and in long-term-care facilities, and we have a catastrophic drug program called Trillium that's an income-based program, with a deductible of approximately 3% to 4% of income, for those people with high drug costs.

As other provinces do, we also cover people on social assistance. That actually means about two million people in Ontario. We pay on average about $1,200 per recipient. Low-income seniors, people on home care and in long-term-care facilities, and those who are disabled tend to have the higher costs, whereas higher-income seniors and those on our Ontario Works program tend to have lower costs.

Trillium is interesting. As we all look at having catastrophic coverage, you'll notice that the average cost per recipient last year was around $1,400. But we actually cover the whole family when a family becomes eligible. Usually it's one person in the family who has the high drug costs, so where we cover one person who typically has very high costs, there are usually two or three or four others in the family who bring down the average.

This is an overview of our programs. I'll turn it over to David to talk about some of the therapeutic areas we see the most utilization in.

º (1615)

Dr. David McCutcheon: The first area we would look at is cardiovascular drugs. Here we're concerned as much about under-use of these drugs as we are anything else. The biggest thing you hear about is making sure people are taking their medications appropriately to prevent downstream effects of complications of cardiovascular disease.

We're very concerned about care gaps in chronic diseases, particularly cardiovascular disease, but also diabetes and hyperlipidemia, where we end up very much treating the complications of these illnesses. We're very concerned about the up to 30% of people we find are taking their lipid-lowering drug three years after initial prescription. There's a significant issue of under-utilization. We're as concerned about under-utilization of drugs as we are about areas of over-utilization, which we might find in areas such as antibiotics, etc.

It's important to note that gastrointestinal drugs, for example, are a very significant expenditure. This relates a lot to the costs around proton pump inhibitors. As you can see, there has been over the years a very significant increase, from $206 million in the year 2001 through to $265 million in 2002-2003. It's certainly a significant increase and a higher increase than one would expect purely from diseases alone. We're concerned about utilization in this area. We're also concerned about the price in this area.

For other items, I refer you to slide 4 of our deck, where you see the growth of 14% in cardiovascular and central nervous system drugs, and growth also of 28% in what we call unclassified drugs. A lot of that growth would be taken up in areas such as Plavix, which is a relatively new drug for antiplatelet activity. But, again, you can see the gastrointestinal drugs at 13% and the others showing significant increases as well.

We're running roughly at a growth rate of 14% annually, which is a very significant pressure on the costs in the drug program.

º (1620)

Susan.

Ms. Susan Paetkau: I'll give you some overview of the costs for the program.

We have been recently running at growth rates of about 15% a year for the last three or four years, and that was after a little lower growth rates through the late nineties. You'll notice we had a dip in 1996-1997. That's when we introduced co-payment into our program. We currently have one of the most generous programs in the country. High-income seniors pay a $100 deductible, and then $6.11 after that. All other recipients pay $2, with the exception of Trillium, where there is the upfront deductible of 3% to 4% of income; thereafter they pay $2 per prescription. That is why we had the dip in our growth at that time.

Where we've seen the significant increase from 10% to 15% in 2000-2001, it is because we introduced two new categories of drugs—or at least, they came on to the market and we started covering them on the program. Specifically, these were Alzheimer drugs and the COX-2s, which are new anti-inflammatory agents. But we expect this type of growth will continue in the future and in fact could be higher if we provide price increases, which we're currently not acknowledging in our program, or if new blockbuster drugs come on.

You'll notice that we currently collect about $300 million in co-payments, based on the details I provided earlier.

The next page gives you detailed projections for our costs. You can see that the main ODB program, which covers seniors and people in home care and long-term care facilities, is the largest component of our program. This year we expect to spend $2 billion for those recipients. The Trillium is a relatively small component of our spending. It's running about $150 million this year, but it is growing at about 25%. We introduced this program in 1995-96 and have experienced about 25% growth per year.

The special drugs program is really an artifact of the past. It's a disease-type program where we cover specific drugs. We have not added any new drugs or diseases since the early nineties; that has been based on the fact that newer drugs are now covered under our Trillium program.

You can see that through these programs we spent just over $2 billion last year. We expect to spend over $3 billion three years from now.

For people on social assistance we're currently running at about $500 million in spending. That's significantly down from the mid-nineties because of the upturn in the economy, but also because of much tighter criteria for coverage under social assistance in Ontario.

Based on the areas you were looking at, we'll talk a little bit about drug prices. We review prices as new drugs come onto the formulary and basically compare them to those of existing products to determine whether to actually list. But we do that as part of a process that also considers comparative efficacy and cost-effectiveness.

Brand name products are primarily regulated through the Patented Medicine Prices Review Board, and we accept whatever those prices are. For multiple-source drugs, we have our own policies in place whereby we reimburse generics at 70% of the brand name and require the second generic to be at 63% of the brand name. Then the third and fourth are at that same level.

Currently, there's no federal or provincial mechanism for non-patented single-source products. This has been an area where we have seen growth over the last decade, and we expect there will be continued increases without regulation.

As I mentioned earlier, we have had a policy since 1994 whereby we have a price freeze and don't accept price increases for products. The only way we'll look at an increase is if a company offers up an off-set, a reduction in another product that's of equal value. Typically, there are no price increases. In fact, we have been experiencing over the last three years a very significant challenge to that policy, particularly as the discussion in the U.S. is increasing, and also as the Internet pharmacy issue emerges.

We went from an estimated 3% of price non-compliance in our claims to 16% last year, and we know it's probably higher than that, because the pharmacist is actually absorbing some of those increases as well. Those levels are before some of the major companies did across-the-board increases or price increases on some of their products.

We are currently reviewing the issue of price changes through an overall review of our program, where we have a multi-stakeholder committee. We have been in dialogue with both the brand and generic industries over the last year. This is something we expect we'll have to grapple with in the year going forward.

In terms of federal opportunity, we really do see that there is room for some leadership with respect to non-patented products, both single-source and multi-source. This has been recognized through the health accord, where it has been agreed that provinces should work together with the federal government in the area of pricing.

With respect to approving new drugs, you're well aware that the federal government looks at safety and efficacy versus placebo. When we look at products for a formulary, we look at comparative efficacy, safety, and cost-effectiveness. That's predominantly comparing to other formulary alternatives, although we very much consider, because of pharma economics, what the downstream savings might be in terms of a product, hospitalization, emergency room visits, etc.

Typically, manufacturers have to make a submission to us when they want to have a product listed. We rely on the advice of the drug quality and therapeutics committee, and have done so since the mid-1970s. We look at new products, not only new chemical entities and line extensions, but we also review the existing products on the formulary in an attempt to modernize our formulary and bring it up to date with the evidence.

With the changes over the last three years, where there has definitely been an effort to harmonize some of the federal-provincial activities, we actually now only review about 20% of the generic products. We are depending on Health Canada's review of bioequivalents for the most part. We're looking at harmonizing entirely over the next year or so.

We are also actively participating in the common drug review process. We expect it to be as rigorous, of as high a quality, and as timely as what we currently have in Ontario, or better.

We actually, as I said, support the collaboration to improve formulary decision-making and reduce the duplication of effort. With respect to the federal government's role, we would very much like to see improved review times for approval of new drugs, especially breakthrough drugs for life-threatening diseases.

We have noted over recent years that we have fallen out of line with some of the major jurisdictions, such as the U.S. and the U.K. We think there is significant room for improvement with respect to the timelines and also with respect to transparency.

º (1625)

Dr. David McCutcheon: Moving on to the adverse effects and prescribing practices, ongoing modernization of the formulary includes the review of the latest safety and effectiveness data, as well as utilization data. I think it's important for us to try to have as efficient and as effective a data acquisition process as we can have.

I think there are significant collaboration efforts to monitor and improve utilization, but certainly at the moment they tend to be ad hoc. They've been pursued with provider associations, both physician and pharmacist associations, and the pharmaceutical manufacturers in specific circumstances, such as particular drugs, drug categories, or even diseases.

We've done some outcome-focused drug utilization reviews that were conducted for us by ICES, but these have been commissioned on an ad hoc basis, as opposed to any strategic or planned basis.

We support the promotion of best practices for prescribing and utilization of drugs through several strategies. The integration of pharmacists into primary care group practices we think is a very important strategy, where the pharmacist and the physician working collaboratively as a team can in fact improve the outcomes for patients. Certainly our new government has made that a significant piece of their health plan.

Knowledge translation to provide clinicians and health care consumers with easily accessible, independent sources of evidence-based information we think is a real challenge. A lot of the information, of course, tends to have the origin of the manufacturer, who has significant interest in the diffusion of that drug in the market.

Decision support assistance for prescribers and pharmacists, including electronic health records, we're very much interested in pursuing through the Smart Systems for Health Agency. The electronic health record, or at least the core data set for electronically held records, is a very important project for us.

We're also looking at the connectivity of the drug information system with the prescriber information through the potential of an experiment using the ODB information and connecting with hospital emergency departments.

We're also into funding and active participation initiatives, such as the Institute for Safe Medication Practices for institutional settings, the Safe Medication Support Service, etc. We're trying to extend significant safety efforts out into the primary and community care section as well.

We're interested in developing more effective strategies for chronic disease management, as I mentioned earlier.

There's certainly a need for the federal government to support a link into provincial post-marketing evaluation efforts, such as collecting outcome, utilization, and safety information across the health care system. We think there's a lot of advantage in that for all of us, not simply for the safety information, but for programs to look at utilization information as well.

Under pharmaceutical manufacturing, at this period in time, the program does not review or track the marketing and lobbying activities of the industry. Brand name manufacturers use multiple channels, such as professional publications, detailing, and drug samples to promote their products and influence physician prescribing decisions. They are extremely effective at the rapid diffusion of their product into the marketplace.

We lament that we couldn't be as effective in terms of diffusion of clinical practice guidelines and other means. Certainly if we had the same workforce in place, I think we could do really well in terms of improving quality of care in diabetes and other illnesses.

The generic manufacturers use very significant rebates and promotional allowances to influence a pharmacist's choice of generic drugs. We estimate that's about $300 million in the country, but certainly it's a very significant issue. This counts for up to 55%, we believe, which is not uncommon where there is steep competition in the generic industry.

Ontario supports knowledge translation through independent sources on therapeutic value and cost-effectiveness. Our DQTC process is extremely efficient at looking at cost-effectiveness. What we're concerned about is that clinical practice guidelines, as they come out, very often ignore the fact of cost-effectiveness. It's a very important issue for us in terms of what goes in the formulary and what's paid for.

º (1630)

We believe we should have collaborative efforts by physicians and pharmacists to improve pharmaceutical care. These efforts should be provider-led, as opposed to industry-led, and should involve patients directly, as well.

We believe there is an opportunity for the federal government to show leadership by providing support for best practices and provincial and professional efforts to improve medication management and regulate pharmaceutical marketing efforts.

My final slide relates to medication management. The ministry supports an integrated approach of health care management to ensure optimal use of medications, including the appropriate and efficient use of health professionals in the care of patients. So, really, looking at interdisciplinary teams and looking within the pharmacy for more efficient use of pharmacists is a very important fact.

We believe we need to have active patient involvement, recognizing that patients now are more informed about medications, through the various venues, than they were in the past. Certainly there's a sense that greater responsibility needs to be taken by the person, particularly the person with chronic illness, to ensure that protocols of care are adhered to.

Certainly we, as a provider group, are not as effective yet in empowering our patients, our clients, with the information they need to map out their routes of care for chronic illnesses.

We think pharmacists can provide a very significant enhanced role, as they have done in hospitals. We'd like to see the revolution, if you'd like, or the “quiet revolution” that took place in hospitals in the 1970s translate out into the primary care system or the community system now, where really the focus of pharmacy becomes that of providing clinical pharmacy intervention or cognitive interventions, as opposed to the emphasis on marketing and business in pharmacy.

More recently we've recognized that programs that are occurring internationally have identified new opportunities that involve pharmacists in primary care, such as the national medicines management services collaborative program in the U.K., where pharmacists and primary care physicians work together collaboratively; the home medication review in Australia, where physicians and pharmacists are remunerated for the specifics of doing significant medication review with patients; and the strategies of Kaiser Permanente in the U.S., where certainly focus on cardiac risk management, diabetes prevention, and anti-coagulant monitoring are very good strategies for chronic diseases management.

We believe there is an opportunity for the federal government to provide base funding for provincial medication management initiatives and their evaluation. We believe we can actually have a win-win situation here where the benefits for the federal government in terms of enhanced patient safety information can be married with the need of the province to get better utilization, and indeed better patient or client compliance with medication regimens.

That concludes the formal part of our presentation. I think we might have gone over our ten minutes, but as you can see, we're very interested and engaged in our subject matter.

º (1635)

The Chair: Thank you very much.

We'll begin the questions and answers with Mr. Ménard.

[Translation]

Mr. Réal Ménard: Thank you, Madam Chair. You’re so unpredictable; if I’d expected that!

First I’m going to make sure that I understand the table on page 6. In the costs that you had or will have in 2003-2004, only 20% of the population of Ontario is insured under a public drug insurance plan. Is that what I’m to understand?

So, it’s 20%. Think that in Quebec, it’s three times that. I think that among the five provincial health departments that have appeared before us, this is the lowest rate of insurance. Perhaps this is a consequence of the common sense revolution, but I won’t ask you any political questions, since that’s not my style.

I’d like to know whether your political analysis departments have studied what the consequences would be for Ontario, which has the least generous coverage of all the provincial health departments which have appeared before us, if there were a faster entry of generic drugs into the system.

I don’t know whether you recall, Madam Chair, but the Health Canada officials told us, at our first meeting, that the other provinces were following Ontario’s example with regard to the refund of generic drugs. What I gather is that Ontario refunds 70% of the cost for the first generic drug and that, for any further generic drugs, there are decreasing refunds. But you obviously depend on the entry of generic drugs into the system.

Do you have any in-house data you could tell us about? If there were a faster entry of generic drugs into the system, what might that mean, with regard to the cost of the system, for the 20% of the population that is insured, since this is your responsibility in your capacity as the public authority?

º (1640)

[English]

Ms. Susan Paetkau: Actually the first comment I would make with respect to the 20% is that we do only cover 20% of the population, but it's just under half of the spending in Ontario on drugs. We tend to cover the patients who are using the most medications. A majority of other people in Ontario are covered by private insurance. We don't have any gaps, because our Trillium program actually covers everybody. It's just that the deductibles are quite high. They're approximately 3% of income at the lower end, going to 4%. We don't have anybody without insurance. Certainly I know that our seniors program is quite generous compared to most other provinces. The high-income seniors only pay $100 upfront and then $6.11 for a prescription, and the low-income senior pays $2 per prescription.

With respect to the effects of generic medicines, I think other provinces are following us with regard to the streamlining and harmonization on using Health Canada's determination of bioequivalence for the most part. We try to update our formulary on a quarterly basis, so we always add new brand-name drugs and generics at that time.

I know there has been interest in perhaps having the generics available immediately as they're licensed or receive their determination of bioequivalence from Health Canada. Based on what's happened on average over the last three years, we estimate that this might only result in a couple of million dollars of savings, because you would actually only be adding the generics about two months earlier than they might otherwise be added. Although with blockbuster generics, and we did have one earlier this year, symvostatin, the savings to the program was—

[Translation]

Mr. Réal Ménard: Wait till I’m sure I’ve understood properly. At present, there is a Patent Act, which we cannot really change because the WTO... Canada went to mandatory arbitration and the act was amended with the passing, a few years ago, of bill S-17; I never remember whether it was in 1999 or 2000. There’s a problem concerning this 20 years, because the regulation on linkage means that it’s no longer 20 years, but 21, 22 or 23 years. This is a debate that affects the industry and that affects the Health Committee.

For your part, you say that if we were more rigorous, if we abided by the 20 years and if generic drugs entered the system sooner, there would be a marginal saving. Is that actually what you’re saying?

[English]

Ms. Susan Paetkau: No, I'm talking from a different perspective here. I'm not commenting on the linkage regulations at all. I'm really commenting on the fact that instead of listing new generics every three or four months, we are looking at the opportunity to do them almost automatically as soon as they get approved by the federal government. We have not done the analysis on the additional cost to the system as a result of the linkage regulations, nor does Ontario have a specific position at this time.

Mr. Réal Ménard: Do you want to add something?

Dr. David McCutcheon: I just to make the point that the focus we have at the moment is on improving our process—once the drug is approved, then how quickly can we get the drug to market. That's the area of focus we've had so far—what can Ontario do to bring these drugs in quicker. The drug strategic review that's underway at the moment is looking at various strategies for that, such as monthly formulary updates or a tightening of the timeframe for approval within the government process itself. There are some strategies that are under consideration at the moment.

We have focused on the areas inside our jurisdiction. Can we tighten them up and bring them to market quickly? That's where we have focused. The other issues we've left to the purview of the federal government to be honest.

[Translation]

Mr. Réal Ménard: Right.

Madam, this will be my last question because, unfortunately, I must return to Ottawa afterwards. You said that as soon as the bioequivalence determination is given by Health Canada, you list the generic drug, which, as a first generic drug is 70% refundable.

Can you tell us a little about the bioequivalence determination? What are Health Canada’s regulatory or administrative waiting periods? Are there any gaps? Are there any things you want to share with us in this connection?

[English]

Ms. Susan Paetkau: Actually where we have harmonized is on the solid oral dosage forms. Over the last three years our experts and Health Canada's experts have actually got together to review specific drugs with which there have been concerns. Through that process, which has actually been a two-step process so far, we have come to an agreement that their processes are satisfactory and meet our standards.

I believe what happened is the federal government was not really in the interchangeability or the bioequivalence business to any extent in the seventies, when the provincial programs got started, so we did it on our own and we built the expertise.

Over the nineties—I think in 1995—there were specific standards put in place so that there is now an opportunity to rely on Health Canada. Our experts feel confident now with all oral solid dosage forms, including those with narrow therapeutic indexes. Most other provinces are still looking at those.

We are now looking at other dosage forms, such as solutions and aerosols and ointments, etc. We have worked it out bilaterally through our experts and we have brought other people to the table in the last year as a lead. As we found a fair bit of resistance from the other provinces, we decided to pursue our discussions with the federal government bilaterally and share the results with others.

[Translation]

Mr. Réal Ménard: Thank you.

I have to leave, unfortunately.

[English]

The Chair: Thank you very much, Mr. Ménard, and thank you for sharing the chair today. Good work on your part.

Mr. Castonguay.

[Translation]

Mr. Jeannot Castonguay: Thank you, Madam Chair.

Thank you to our guests. At the very beginning, you talked to us about such things as drugs for lowering cholesterol rates. You gave the example of Lipitor, I think, and you said that one of your concerns was that sometimes people are no longer taking it three years after the diagnosis was made. It worries you that there is under-use, because that could entail other expenses in the health care system, if I understood properly.

Do you have any idea of why there is under-use at that time?

º (1645)

[English]

Dr. David McCutcheon: Yes, that's correct. The concern we have is that a patient is identified as needing it, they're prescribed it, and then over a period of time their compliance with the drug falls quite significantly. Because lipid lowering is a lifelong issue, the issue is what strategies can we contemplate to help people continue on the medications on a prolonged basis.

That was one of the examples I gave to indicate we may not be spending enough in certain areas, such as this, because if they have the cardio-protective effect, and people are not taking them, then we are paying for the acute MI and for the stroke and for the people living with significant morbidity subsequently.

Mr. Jeannot Castonguay: I understand that, but do we know why people don't take it? Is it that they cannot afford it, or is it that they just don't want to take it?

Dr. David McCutcheon: It's available in the program, so it's not necessarily an issue of being unable to afford it. I don't know whether people feel that over time, once they've taken it for a few years, next time it will last through for a time, or that they've changed their diet, or whatever. But it's something that really needs to be studied very carefully, because we're very concerned about it.

[Translation]

Mr. Jeannot Castonguay: So I could conclude that, finally, patients would need to be educated concerning the importance of consulting a health professional before they stop taking drugs like these.

Obviously, we can see that the price of drugs is increasing from one year to the next. Do you have any data that would enable us to see whether, on the other hand, there are any greater savings to be made in the field of health care overall? Indeed, if, because of the drugs that are prescribed, heart attacks and hospitalizations can be avoided, then perhaps we can invest $100 here, but save $1,000 elsewhere. Do we have any data about that? We asked other witnesses, but they didn’t have any information. Do you have data in this regard, in Ontario?

[English]

Dr. David McCutcheon: I'm sorry, we don't have the statistics. We'd really love to have them.

There are several studies that have been done. The Lichtenberg study has been done in the U.S., although it's very difficult to look at it from a macro-economic perspective. We'd love to be able to do prospective economic studies of the value of drugs in terms of the prevention of downstream complications. One would want to have a long study underway to be able to do it, but it's something that we see.

Certainly the DQTC, in considering whether a drug should be listed or not, takes into account cost-effectiveness, which includes costs avoided in the rest of the system.

Mr. Jeannot Castonguay: Do you believe the federal government should play a role in this? We hear about the rising costs of medication, but I personally believe we have to look at this within the context of the whole health care system. Do you believe we should play a role in trying to find that information?

Dr. David McCutcheon: I think to generate that evidence would be a very important role, or to cause the evidence to be generated—in other words, to commission, or through chairs, or the establishment of centres for evaluation of medicines, etc. It would be that kind of idea. We need an independent group to look it, because a lot of information we get is at the introduction of a drug. We really need to look at whether what's predicted at the time a drug is introduced in the market is actually sustained over the life of the drug.

In our drug strategy review we're looking at concepts such as conditional listing. A drug might be introduced into the market and we gather the data while the drug is in the market in order to establish whether the cost-effectiveness that was predicted at the introduction is in fact sustained in the marketplace three or five years down the road.

º (1650)

Mr. Jeannot Castonguay: Another point here. You say, “Ontario supports promotion of best practices for prescribing and utilization through integration of pharmacists into primary care group practices.” Do you have many of these groups in existence right now? Is this a program that is in place? Is it only through hospitals, or is it in the community? I would like to hear more about this.

Dr. David McCutcheon: First of all, at the moment, the previous government approved a pilot project where pharmacists and physicians can work collaboratively in the primary care environment. We do have some research activities that have gone on.

There was the SMART project in Hamilton, for example, where a pharmacist working physically within a physician's office had access to the charts, and having assessed the patient's chart was able to book time with the patient and then make suggestions for change in the prescriptions for the patient. They found that there was an improvement in utilization, both under-utilization and over-utilization, and that there was an effective relationship established between the pharmacist and the physician. We'd like to extend that further, so the government has identified some money and there will be a call for proposals very soon to bring that forward.

Also, the new government that has just been elected has in its election manifesto identified family health teams as a significant primary care strategy. Those teams specifically mention pharmacists as a member of the team. We're very confident that we're going to be able to move into the community with very significant relationships between physicians and pharmacists that will improve patient outcomes.

Now, it's important to say too that it's not that there has been an absence of clinical activity by pharmacists in the province. Let me not mislead you there. Pharmacists themselves in their good professional practice have been providing very significant clinical advice to patients, as they present in their pharmacies.

The issue is that they're devoid of the important clinical records. Through collaborative practice, working together, we can have the extra benefit of the pharmacist having knowledge of X-ray reports, lab reports, or whatever it might be, and really becoming very much a part of the care team, as opposed to an island of care away from the physician.

Mr. Jeannot Castonguay: I understand then that it is more than a pilot project at this stage. You already have evidence that it works.

Dr. David McCutcheon: We have evidence that the relationship can exist under our benefits for patients, and we need to translate that into widespread practice.

The Chair: Thank you very much.

Mr. Barrette.

[Translation]

Mr. Gilbert Barrette: Thank you. I’m sorry to have been absent

[English]

to be absent a couple of minutes, for nearly most of your presentation.

What is your position about the implications of the federal government in the nationwide drug program across the country--maybe pharmacare?

Dr. David McCutcheon: I think the first thing for Ontario is that we'd like many of the other provinces to catch up with us in some of the programs we have. I don't know what our new government's position will be with regard to pharmacare, so I can't give you that answer at the moment, but certainly we believe that the Ontario drug benefit program is a very significant benefit, and we believe it to be one of the best programs in the country in terms of the level of benefit that is provided to people.

We don't believe we should stop there. We believe we need to continuously review it, and certainly at the moment we're reviewing how the program is administered and some of the pricing and other issues.

We will be consulting with our minister with regard to what other reviews the minister would want, but given that we've only had a minister for a few days, we haven't had the opportunity to have that level of dialogue with him. My apologies that my answer is evasive, but it's because I cannot give you the position of the province on that yet.

º (1655)

Mr. Gilbert Barrette: This is my last question.

On page 9, in the last paragraph, you say there is a need for the federal government to support a link to provincial post-marketing and so on. Will the next health council fulfill that responsibility?

Dr. David McCutcheon: What we're looking for is a system to gather data and to have that data adequately analyzed. It's not so much that we're concerned on the high policy level. We're more concerned on the practical level as to how we can get information from the experience of the patient and the physician and translate that into aggregated information based upon the introduction of new drugs or the behaviour of existing drugs in the system. The concern would be that there is use creep in the system, so a drug has a specific pattern of indications as to whether those indications are widening in the system and whether practices are moving beyond the approved use of those drugs. These are some of the concerns.

There is also the issue about the fact that in clinical trials there is a very well-controlled environment for people, but when the drugs are actually used in a non-controlled environment, are the complication rates the same or are they worse, or are there other experiences when a drug is used for a population as opposed to a small group of patients, relatively speaking, in a clinical trial? That's the kind of use we are looking at so there is a richer value coming out of the interaction among the pharmacist, the patient, and the physician.

Ms. Susan Paetkau: Actually, we'd very much like to see the relationship among the physician, the pharmacist, and the patient develop so that we are collecting the information around outcomes and safety on an ongoing basis at that point of service, then reporting it through to the feds.

Right now, what we have with respect to adverse drug reporting is very ad hoc. It's not systematic, so it takes a long time once the drug's on the market to actually see the incidence of certain types of side effects that are very serious. That's why you see drugs being pulled off the market after five or ten years. We do not have systematic reporting, and that's what we're concerned about and feel should actually be built into the front-line service.

The Chair: We had evidence earlier in our hearings that the kinds of forms that are used actually dissuade physicians from reporting. Then we had evidence today that I found interesting: apparently, to actually prove that a drug is dangerous you have to prove this cause-and-effect relationship. Apparently, this hasn't even yet been proved, in a scientific way, between tobacco and lung cancer.

The particular witness I'm referring to was suggesting that the method for reporting adverse reaction be simplified, and that the test be one of association as opposed to cause and effect, whereby the doctor wouldn't have to say this definitely caused this reaction but could describe the patient's age, weight, general condition, and then say “I prescribed this and this is what happened”. At that point, if it were sent to a central source, you could begin to collect and collate that kind of information. That might be kind of a better early warning system than waiting, as you say, 10 or 15 years.

Would you agree with that, and would that be a federal responsibility, or...?

Ms. Susan Paetkau: We absolutely agree. I think it has to be a joint responsibility.

I think the collection of that data has to happen at the front line, at the point of care, and then we have to have the information systems that actually collect that fairly easily--

» (1700)

The Chair: Make it easy.

Ms. Susan Paetkau: Perhaps that's part of the development of the electronic medical record, but really, it requires physicians, pharmacists, and patients to work together to actively report, and then the analysis--the investment in the evaluation of that data--has to happen.

I think there also needs to be a lot more sharing. Certainly the roles between the federal and provincial governments are not really built on that sharing; they're built on individual responsibilities. We find that even in trying to look at our assessment of a drug in the province, we cannot access some of the information that Health Canada has used in reviewing the product, and we look at the same issues, as well as costs. So we think we need to open up that relationship and work together in this area. It's very important.

Certainly as we see a lot of the new drugs coming forward we're actually covering them on a case-by-case basis. We're documenting what's required in terms of decisions around reimbursement, but we'd actually like to build that into a post-marketing evaluation database. So we systematically collect information related to outcome, safety, and utilization so we can see, front line, how that evidence evolves. Right now we really are doing it for reimbursement purposes and compliance with certain criteria that we set up front, rather than seeing what happens down the road, and we continue to be reliant on the industry to give us the data. We feel there needs to be a way to collect that independently as well.

Dr. David McCutcheon: To add a comment, between us we have placed a huge burden on the physicians in their offices. We, as the drug benefits program, have a limited-use system and a section 8 system. The section 8 system is individual clinical review, which is a prospective approval that's required before a patient receives a drug, and I think we're now getting nearly 150,000 requests a year.

So if we think about our 6,750 comprehensive family physicians or the 8,000 or 9,000 specialists--or probably even fewer--who are asking for these, we really are placing a significant administrative burden on clinicians.

So I think any system that would help us in terms of an artificial intelligence-based system based upon the electronic health record and electronic prescribing would be extremely beneficial in terms of moving it forward.

I think there's an opportunity for the federal government, through its influence with Canada Health Infoway, to really look at effective information systems that can be put in place that would help in terms of the electronic health record and linking of the pharmacy information databases. In that way, the reports that are required can be generated through some good decision management strategies, if you like, employed within the information technologies themselves.

The Chair: Good.

Thank you very much for coming. I know you've had a busy day, and you have to get used to a new minister, which is a job in itself. We happen to know him. We can assure you he's very easy to get along with.

Dr. David McCutcheon: We've already had some meetings. Not only is he easy to get along with, he's extremely enthusiastic in his position as well. So we expect to have a very lively time in the Ministry of Health in the next while.

The Chair: I'm sure you will.

Thank you for coming, and thank you also for the work you do every day for Canadian citizens and their health care.

Dr. David McCutcheon: Thank you very much. It was a privilege.

The Chair: Thank you.

The meeting is adjourned.