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EVIDENCE

[Recorded by Electronic Apparatus]

Thursday, March 20, 1997

.0902

[English]

The Chairman (Mr. David Walker (Winnipeg North Centre, Lib.)): Pursuant to Standing Order 108(2), a review of section 14 of the Patent Act Amendment 1992, chapter 2, Statutes of Canada, 1993, the committee resumes its work with a round-table discussion.

We have some witnesses here. I'd like to apologize for starting late. We usually start right on the moment.

Witnesses, there are going to be bells at about 10:05, but they will be half-hour bells. We'll continue to work through the bells, so we should have time to finish up our work. Don't be side-tracked by the ringing.

Dr. Michael Rachlis is here. Welcome. We've seen each other before. Another Winnipegger originally, right? And Dr. Philip Berger is here, who tells me he's also a former Winnipegger.

And, sir, you're Mr. Brucel, from the Urban Community of Montreal -

Mr. Jean-François Brucel (Representative, Office of Economic Development, Montreal Urban Community): Yes.

The Chairman: Bienvenue.

The Clerk of the Committee: And on the other side, we have Madame Toupin.

The Chairman: Oh, I'm sorry, Lynne. I didn't see you because I was looking the other way. Welcome. And with you, Lynne, is Mr. Farrell.

Mr. Mike Farrell (Assistant Director, National Anti-Poverty Organization): Yes.

The Chairman: Thank you.

In a round-table meeting, we like to have witnesses speak for about five minutes each in outlining their presentations. Don't feel you have to read your brief, because it's part of the record and the committee members and researchers read it. We just want you to be involved with the conversation. After that we'll have a round-table discussion for about an hour or an hour and a half. We'll have lots of things to say back and forth and so forth.

I'm going to turn to Philip. Do you want to speak first? Introduce yourself properly, telling us what you're doing, and then give us your presentation.

Dr. Philip Berger (Individual Presentation): Okay.

My name is Philip Berger. I'm the chief of the Department of Family and Community Medicine at the Wellesley Central Hospital in Toronto and an assistant professor in the Faculty of Medicine, University of Toronto. I've been an AIDS doctor since the epidemic began in the early 1980s and as a result have interacted with the pharmaceutical industry for the past decade.

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In my judgment, terms and conditions that protect the public good should be applied to pharmaceutical companies in exchange for patent protection provided by the federal government, no matter what the length of patent protection determined by the government. I don't have a particular view on the length of patent protection and will confine my remarks to the terms and conditions of patent protection.

HIV treatment has advanced substantially over the past ten years, and over the past year in particular patients who were dying of AIDS have benefited from the research sponsored by the pharmaceutical industry. Some patients, and I've witnessed this personally, have experienced spectacular improvements in their health. They have been brought back from the brink of death.

The pharmaceutical industry has been generous in its funding of educational events for both doctors and consumer groups. Barriers to patient autonomy have been broken down, experimental drugs are accessible mostly without impediment, and human rights for people with HIV have been largely secured.

But these victories have been accompanied by unprecedented industry violations of conflict of interest principles, breaches of advertising provisions under the Food and Drugs Act, and private funding arrangements with some AIDS activists and many physicians that are contrary, at least for physicians, to Canadian Medical Association guidelines.

The pharmaceutical industry's conduct threatens the integrity of treatment recommendations for patients and undermines common-law rulings on informed consent for patients considering anti-HIV therapy. If patent protection of whatever length is to be provided to the companies, then certain terms and conditions must be applied to the patents in order to protect the public interest.

Let me briefly go over some examples of improper conduct - in my view - by the pharmaceutical industry in relation to doctors and patients.

In 1991, I was offered $5,000 unconditionally by a drug company to attend an international AIDS conference. I declined the offer. I later discovered that the company had, without my knowledge or consent, registered me at the conference and paid the $600 fee for the conference. In January 1996, another company offered me $1,000 to attend an AIDS conference. There was no change in five years except for a reduction in the amount of money.

AIDS doctors and AIDS activists are regularly appointed to so-called ``company advisory committees'' at honoraria of up to $1,000 per day, these advisory sessions consisting of elegant dinners and a day of listening to company presentations.

Purportedly new research findings are announced at extravagant press conferences organized by public relations firms hired by the pharmaceutical industry, and they occur with an otiosity exceeding that of the recent media advertisements paid for by the Pharmaceutical Manufacturers Association of Canada.

Leading AIDS activists, researchers and physicians, lending the credibility of their stature, speak at these conferences, which are de facto advertisements. Health Canada remains silent and has never enforced the advertising provisions of the Food and Drugs Act with respect to these press conferences.

In 1996 a drug company bypassed its own lottery system for a new AIDS drug in limited supply and offered the drug to leading AIDS activists across Canada. In one instance at least, the company offered the drug in exchange for the activist's appearance at a press conference promoting the drug. A few activists, placed in the untenable situation of balancing their own personal interests - that being access to life-promoting drugs - against fairness and equity of access in the lottery system, accepted the offer and sold their souls in order to gain a temporary reprieve for their bodies.

Finally, in October 1996 the federally funded Canadian HIV Trials Network organized a national treatment consensus conference, in which company marketing and sales representatives actively and fully participated in the generation of recommendations for when and how to treat HIV-infected persons with the companies' drugs.

Seven members of the eighteen-member working group in which I participated were pharmaceutical company representatives. Our group made recommendations on when to initiate anti-HIV therapy. Those recommendations bore directly on the financial interests of the companies whose representatives participated in the discussion. The earlier we recommend treatment, the greater the sales of the drugs.

Furthermore, company representatives sat at the same table as scientists and clinicians who depend on the very same companies for funding. All present denied a conflict of interest, as a torrent of terminological legerdemain, such as ``partnership'' and ``community'', reigned at the meeting in defence of company participation.

The integrity of the information and recommendations is compromised and patients will be making treatment decisions based on a flawed and biased consensus conference held under the auspices of a federally funded trials network. Informed consent will be vitiated if patients rely on these national treatment recommendations, which were generated with the participation of companies who have a direct financial interest in what physicians and governments advise patients on therapy choices.

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The Health Canada representative at the consensus treatment meeting was contemptuous at the notion of conflict of interest and queried sarcastically whether the Government of Canada should also remove itself from the meeting over a conflict of interest, although the speaker never explained what she meant. The Health Canada representative should not have removed herself because of a conflict of interest. She should have left because she had failed in her duty to protect the public from biased information.

Considering the perilous entanglement of physicians, AIDS activists, the federal government and the pharmaceutical industry, I recommend that the industry committee examine the following terms and conditions that could be placed on the pharmaceutical industry in exchange for patent protection.

First, require annual public disclosure of the identities of all individuals, including patient representatives and organizations, who receive funding from drug companies for any purpose.

Second, enforce the advertising provisions of the Food and Drugs Act and prohibit industry-sponsored press conferences prior to the publication of scientific findings in peer-reviewed medical journals. The only exception to such enforcement should be extraordinary discoveries that substantially prolong the length of persons' lives or substantially improve quality of life.

Third, prohibit drug companies from offering experimental medications to patients outside of an established public system of the equitable distribution of drugs in limited supply.

Fourth, prohibit federally funded agencies such as the Canadian HIV Trials Network from including pharmaceutical company representatives in consensus conferences for developing treatment recommendations.

Fifth, require disclosure from physicians and scientists who advise Health Canada on drug approval of past and ongoing financial relationships with companies seeking drug approval.

Last, prohibit physicians and scientists from advising government on drug approval if those individuals have an ongoing financial relationship with a drug company seeking approval of its drug.

Just as drug companies expect patent protection, the public has a right to expect terms and conditions on those patents that protect the public interest.

Thank you for listening to me.

The Chairman: Thank you, Dr. Berger.

Dr. Rachlis.

Dr. Michael Rachlis (Individual Presentation): Good morning. I want to start my testimony by saying the nicest thing that any Canadian can say to another Canadian: it's spring!

Voices: Oh, oh!

Dr. Rachlis: With that happy news, I'd like to thank the committee for agreeing to hear me this morning. It's a real pleasure to be following my good friend and colleague Dr. Philip Berger.

I want to start by pointing out that the National Forum on Health has issued an excellent report. It's full of excellent analysis and recommendations, and amongst other things, of course, the forum has recommended that Canada establish a national pharmaceutical program as did, I might add, the 1964 Royal Commission on Health Services.

Canadians have been waiting for over thirty years for the fulfilment of our dream for medicare. Our dream for medicare is at present incomplete by not including such important medically necessary services as pharmaceuticals and home care.

I want to add that it is distinctly possible to bring in such a program, and in particular, I want to add that it is financially feasible. The overall administration of a publicly insured pharmaceutical program would be lower than the present hodgepodge of public and private programs. Just as Justice Emmett Hall concluded in 1964, the public administration of health insurance is more efficient than the private administration, and the savings on administration alone should enable us to fund the program.

The federal government has been accused of simply using the national health forum as a smokescreen for its real agenda during its first term of maybe two or three in office. So you do have a chance to get this right. The government has been accused of this because the real agenda has been identified by many as simply the axing of transfer payments to the provinces for health, social services, and post-secondary education.

I want to point out that the government members of this committee have an opportunity to prove the critics wrong by strongly supporting the forum's recommendation of a national pharmacare program. There are several things the committee can do to facilitate this.

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First, I think the committee and the government should get better expert legal opinions on the present limits on patent protection. I was distressed to read in the newspaper that Health Minister Dingwall noted that as far as he knew an outside legal opinion had not been sought on whether or not we could limit patent protection to less than 20 years. I'm not a lawyer, but I've read the cogent arguments of both Mr. Barry Appleton and John Dillon on this matter. I think that in particular, if the government were serious about moving towards a national pharmacare program, there may well be opportunities even with our existing trade treaties for the government to limit patent protection. So I think that if it is true that the most expert legal advice in the country on this issue has not been sought, then the government should certainly do so, and the committee should have that legal opinion available to it before it makes its final recommendation.

Second, I think that the mandate of the Patented Medicine Prices Review Board should be expanded. At present it only has jurisdiction over patented drugs, but over half the prescriptions in Canada are for generic or single-source, non-patented agents. The PMPRB should also be given the authority to regulate the prices of these drugs.

At present the board can only consider the price of a new drug in relation to the prices charged in seven other countries that tend to have the world's highest prices. It's like saying that we have a much cheaper health care system than they do in the United States. That's not necessarily the greatest claim in the world. So the PMPRB should consider the price of new drugs in relation to all OECD countries, not just the seven with the highest prices.

At present the board treats category three drugs, so-called ``me too drugs'', no differently than category two drugs, and this results in higher drug prices within therapeutic classes. Instead, the PMPRB should discount the inception price of ``me too drugs'' according to the number of existing drugs in that therapeutic class.

At present the board does not consider the overall return on investment of the firms it regulates. This is in contrast to other federal regulatory agencies, for example the CRTC. I think that the board should also be required to consider the return on investment of drug companies when it regulates prices. The industry has provided the best return on investment of any sector for approximately 30 years.

Third, although it's a regulation and it could be done immediately, maybe your committee's recommendation would facilitate changing the notice of compliance regulations, which presently prevent the earlier entry of generic drugs. You've seen this in The Globe and Mail, and you've heard of it from others. There's no excuse for drug companies having greater protection for their patents through frivolous court actions than any other patent holders have.

Fourth, I'm very distressed to hear that various medical groups, such as the Canadian Medical Association, do not plan to testify before this committee. I think that is further proof of what you've heard from others, and perhaps including my colleague this morning - that is, the unholy alliance among medicine, the biomedical research community and drug companies in this country. It is a matter of national shame. This committee should require the Canadian Medical Association and other key medical groups, such as the Royal College of Physicians and Surgeons of Canada, to testify before this committee on how Bill C-91 has affected biomedical research, medical care and the delivery of other health services. They should be required to testify before you. They should not be allowed to hide away from this committee and from Canadians, perhaps with the money they've received from the pharmaceutical industry. The Canadian Medical Association, which represents the medical profession in this country, holds in sacred trust much key knowledge for our society, and they should be required to testify before this committee.

Fifth, I think that most Canadians would consider matters of pharmaceutical policy to be primarily health issues, and with deference to the committee and its chair, I feel that the Standing Committee on Health should also be holding hearings on this issue. Drugs are much more a health issue than a commercial one as far as most Canadians are concerned.

Sixth, the biomedical research agenda should not be set by the head offices of pharmaceutical companies that are situated outside of Canada. As you know, there was an excellent editorial in the Canadian Medical Association Journal last year by Dr. Patricia Baird, the former chair of the Royal Commission on New Reproductive Technologies.

Many Canadian physicians and researchers have indicated their serious concern that the research agenda in biomedicine in this country is not being set by publicly accountable bodies. Given the profitability of the pharmaceutical companies, a proportion of the sales of every company should be returned to public research agencies. This could be qualified and fashioned as Dr. Eastman recommended in his report 10 years ago; that is, more money would be taken from those companies that perform less research in this country.

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Seventh, although I don't know if it's the purview of this committee, we must do something to prevent direct consumer advertising from being developed, and there should be a ban on the marketing of drugs to doctors.

Pharmaceutical marketing serves no useful purpose. It only leads to increased inappropriate use of pharmaceuticals. Doctors can, and should, become informed about the appropriate use of drugs from neutral sources: professional societies, peer-reviewed medical journals, and so on. A number of studies have shown that physician prescribing practices are detrimentally affected by pharmaceutical advertising.

The prospect of direct-to-consumer advertising is even more ominous. If doctors are bamboozled by drug company advertising, then what chance do patients have? Banning current marketing to doctors would free up hundreds of millions of dollars, which could be used for basic research or to lower prices.

The members of this committee have been presented with a series of detailed complicated arguments about the impact of Bill C-91 on pharmaceutical prices in Canada. However, I would like to urge the committee members, particularly the government members of this committee, to look to your hearts rather than your calculators.

We first need to deal with our values before we can enunciate policy in this area. The recent report of the National Forum on Health again highlighted the importance of values. The forum found that Canadians extremely value their health care system, and in particular they highly value equity and efficiency, the twin pillars on which medicare was based.

I urge the members of this committee to first review your own values. Do you believe, like most Canadians, that health care should be prudently provided to people according to their health care needs, or do the members of this committee believe Canada's health care system is simply another commercial opportunity?

You cannot accomplish your task in reviewing Bill C-91 until you have clarified your own values. There is no choice in this matter. You are either on the side of the multinational pharmaceutical companies, or you are on the side of Canadians. You cannot have a middle road.

I would also say that you would not be doing your jobs properly unless the pharmaceutical companies in this country were screaming at you for incursions on their so-called rights and interests, because I think it is a truism that if they are not screaming, you have not done your job properly.

Thank you.

The Chairman: Thank you.

[Translation]

Mr. Brucel.

Mr. Brucel: I would like someone else to proceed first, because Mr. Paquet was supposed to...

[English]

The Chairman: From time to time we ask all the witnesses and all the people in the audience to make sure that their cellular phones are turned off when they're in here.

[Translation]

Mr. Brucel: I am waiting for a message from Mr. Paquet, who is on his way here. I will deactivate it for the time being, but if someone could proceed before us...

[English]

The Chairman: You want us to go to the other witness first. Okay.

[Translation]

Ms Lynne Toupin (Executive Director, National Anti-Poverty Organization): I would just like to thank the committee for giving us an opportunity to express our views here this morning. We stated our position during the last round of hearing. Our concerns are still much the same, but our recommendations are probably more specific than they were four years ago.

I will now turn the floor over to Mr. Farrell, who will be making the presentation on behalf of the National Anti-Poverty Organization this morning.

[English]

Mr. Mike Farrell (Assistant Director, National Anti-Poverty Organization): Good morning. Thank you for inviting us here today. I'm going to give you a brief summary of NAPO's position on Bill C-91.

For us, the main issue is one of balance. It's a question of balancing off competing interests: one is the interests of the pharmaceutical companies, the other is the interests of the Canadian public. Patent protection is about trying to strike a proper balance between those two interests. On the one hand, you provide excess monopoly profits to the pharmaceutical companies in order to encourage them to innovate, and also to compensate them for development costs. On the other side, the public bears the excess cost with the expectation that at some point in the future they will enjoy the widespread benefits of the innovations. We feel that Bill C-91, the way it is now, doesn't strike the proper balance.

When I first starting looking at Bill C-91, I started with the whole issue of drug prices because I was trying to figure out whether prices were too high and how much they have been increasing. It was getting pretty complicated. But what I realized was that whether or not they've been increasing more or less than inflation, or whether or not they've been increasing more or less than in other OECD countries, we know they're higher than they would be if we had shorter patent protection or if we still had compulsory licensing. It goes without saying that if we had competition, the prices would be lower.

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So what I looked at next was how Canadians feel about drug prices, because despite whatever analysis has been done by the pharmaceutical companies or by the PMPRB, I think the most important thing is how Canadians feel about drug prices. I looked at an Environics poll that said 80% of low-income Canadians think drug prices are too high. To me, that's a significant number of Canadians, and I think we should listen to what they're saying.

What occurred to me was the analogy that if I decided that I wanted maybe to install a shelf in my kitchen and I contacted a carpenter, an expert carpenter who had years of experience and training, and he came into my kitchen and said to me, ``Okay, based on my experience, I think the shelf should be set at about eight feet above the floor'', I don't need an expert to tell me that's too high. I think the situation is similar with drug prices. Canadians are saying drug prices are too high, and I think we have to do something about it.

The other thing I want to talk about is the impact of the high drug prices on low-income Canadians, because I think low-income Canadians, in particular, have to bear a heavy burden with Bill C-91. Low-income Canadians typically aren't covered by private drug insurance plans, so the impact of drug prices hits them particularly hard.

There are two areas where the drug prices hit low-income Canadians. One is if they're on social assistance very often they're covered by provincial drug plans, but because of the high drug prices, provinces have been cutting back on their drug plans through introducing co-payment fees, deductibles, or delisting brand-name drugs. We've already heard stories of individuals who are on a brand-name drug that was covered by a provincial plan, but when the plan delisted the drug they were forced to go onto a generic drug that was less effective and also had negative side effects.

On the other side, we have low-income Canadians who are working, typically in part-time jobs or in low-paying jobs, and are not covered by drug insurance plans. Those Canadians have to pay for drugs out of their own pocket.

To compound the problem, low-income Canadians typically have generally poorer health than other Canadians because of the stress of poverty. So not only do they pay higher prices, but they need more drugs as well. So this is the reality for low-income Canadians.

After all this, it seems clear that Bill C-91 has created a financial barrier that prevents low-income Canadians from having the same access to health care in Canada as other Canadians. I think that's a serious issue.

It reminded me of something I read in the Liberal red book, and I have a quote here:

I take that seriously. I think Bill C-91 jeopardizes that commitment that the Liberals have made, and I think the government should make some significant changes to Bill C-91.

I have some suggestions and recommendations. I'll go through them briefly.

First, we support the immediate development and implementation of a national universal drug plan. There's no excuse for not having one, and it's the only way to make sure that all Canadians have the same level of health care.

Secondly, we'd like to see the PMPRB have an expanded mandate to cover all drugs, not just patented medication but all drugs.

Thirdly, new patented drugs should be classified by the PMPRB based on their potential for significant breakthrough in terms of therapeutic benefits. This is to somehow control that ``me too'' effect that we're seeing. The classification, combined with independent analysis of the development cost and allowing for reasonable profit margin, should be used to determine the price of new drugs.

Fourthly, the length of exclusive patent protection should start at four years from the time the drug hits the market and could be increased in relation to the classification of the drug. The better drugs would be allowed greater patent protection, but the maximum should be six years. This is in line with what Canadians believe is a good length of time for patent protection. The majority of them believe that four or five years is what patent protection should be set at.

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Compulsory licensing should be reinstated. Royalty fees could be based on a graduated scale so that drugs that are more innovative would earn a company higher royalty fees. A portion of the royalty fees should go to an independent agency accountable to Parliament that would be responsible for providing grants for research into health care. The priorities for research would be established by the federal government.

That's about it.

The Chairman: Thank you very much. You have some very good ideas there, Mr. Farrell. I appreciate your perspective, and I think we all very much appreciate the implications pharmaceutical products have for low-income Canadians. I wanted to make sure you were here at the table.

[Translation]

Our next group is from the Montreal Urban Community. Who is the spokesperson? Is it you, Mr. Paquet, welcome. You may proceed with your brief.

Mr. Bernard Paquet (President, Economic Development Commission, Montreal Urban Community): We apologize for being late, Mr. Chairman, ladies and gentlemen.

I would like to start by thanking you personally and on behalf of my elected colleagues from the Montreal Urban Community for your kind invitation to take part in your committee's proceedings and in the debate surrounding the issue of drug patent protection in Canada.

Before getting into the heart of the matter, I would like to point out briefly that the Montreal Urban Community is an organization that includes the 29 mayors from the island of Montreal. The MUC represents 1.8 million residents.

The MUC is responsible for administering public safety, public transportation, the environment, real estate assessment for taxation and attracting investments to the island of Montreal. These are just some of our main activities. The Community has standing commissions whose main roles are to develop strategic directions and to defend the interest of the Montreal Urban Community.

There is the Economic Development Commission, which I chair. I took over from Mr. Nick Discepola, who became a federal member of Parliament and a member of this committee. Mr. Discepola, the federal Mps from Quebec and some ministers will certainly recall the efforts made by the Montreal Urban Community generally and the Economic Development Commission in particular with respect to this issue.

In 1984, when corporations such as Abbott, Smith Kline & French, Recherche Pharma and Ayerst, for example, were closing their research centres in Canada, the MUC asked the federal Minister of Consumer and Corporate Affairs to amend section 41(4) of the Patent Act as quickly as possible in order to prevent continued erosion of Canada's pharmaceutical industry.

Now that Bill C-91 is being reviewed, we want once again to express our support for the patent drug industry that is so prominent in the MUC and the greater Montreal region.

In light of the 7000 employees and the $260 million in annual research and development investment generated by this industry in Quebec, mainly in Montreal, the interest of the MUC is clear: to protect and promote the development of the established pharmaceutical products corporations in the region and biotechnical corporations, which must be able to count on a intellectual property protection system for their new products.

Indeed, what most distinguishes the patent drug industry from the generic drug industry is the extent of R & D carried out for new drugs. In this field, the very young biotechnology industry, already invests twice as much money but without adequate intellectual protection, corporations such as Biochem, Algene and Haemacure would certainly not have been founded.

This R&D spending also has indirect economic benefits, some clear and some less clear, but nonetheless real: all R&D efforts involve highly qualified employees, with higher salaries than in the generic drug industry and thus naturally higher consumer spending in the local economy.

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A factor that lends itself less to clear quantification is the possibility for our young university graduates of finding jobs for which they are qualified in a leading-edge industry, not hundreds of kilometres of home or south of the border, but right in Canada.

Granted, Mr. Chairman, generic drugs would make possible savings in the health budget. In our opinion, however, that is a very short-term view, because it would deny the discoveries of the past that have not only saved lives but also helped reduce the costs of hospitalization and surgery.

The last point, on which I would like to conclude this brief presentation, has to do with Canada's international competitiveness in the race for investments and jobs in the pharmaceutical sector. Protection inferior to that offered in Europe and the United States would put Canada at a competitive disadvantage. The indirect economic benefits of investments such as those made by Astra Pharma, Bio Intermediar, and other corporations not only are felt in the region where the corporations are located, but also, let us not forget, increase Canada's visibility in the international pharmaceutical community.

For all these reasons we have just briefly noted, the MUC wanted to present this brief to your committee today in order to express its support for the patent drug industry and for an extension of drug patent protection that would give Canada the same level of protection as that offered in the United States and Europe.

This concludes my presentation; thank you for your attention.

The Chairman: Thank you very much. You did very well, particularly considering you had to travel from Montreal to make your presentation.

[English]

I appreciate the different points of view that we have. You can tell there are people who feel strongly but differently about this issue. We have round tables so that those people are here among us and we can test different ideas.

In a moment I will turn to Monsieur Brien to begin the members' interventions. I just want to tell the witnesses that from time to time a member directs his or her question at a certain witness. If that's the case and you wish to intervene, just indicate to me that you want to say something too. Sometimes the question is directed generally, and you can just put up your hand if you want to participate in that particular question.

[Translation]

You have the floor, Mr. Brien.

Mr. Pierre Brien (Témiscamingue, B.Q.): I'd like to welcome all our witnesses. My first question is to Mr. Berger.

My colleague, Mr. Ménard, is not here this morning, but he would have found your presentation very interesting. He has a private member's bill himself - I don't know whether you know about it, but I'm sure he will tell you about it once I pass on your brief to him. The purpose of his bill is to increase the powers of the Patented Medicine Prices Review Board to give it a mandate to study and report on the whole issue of humanitarian access to drugs produced by innovative drug companies. In general terms, would you agree with such a bill?

[English]

Dr. Berger: Thank you for the question. Of course I would agree with the initiative. I do have to say, to give the Canadian government credit, that Canada is probably more advanced than any other industrialized nation with respect to providing access to experimental medication for HIV-AIDS, and it has been so since about early 1988.

Most pharmaceutical companies do release their drugs under compassionate acts programs, including the lottery systems, which they sometimes go outside of, as I mentioned. They do so prior to the issuance of a notice of compliance. The only problem I see is that the release of medication is in fact not controlled by decision-making bodies in Canada. It's controlled by the international offices of multinational corporations. Sometimes our access to medications has been restricted by the international offices. Further, the distribution and collection of information on these drugs is often run by American companies, not by Canadian companies.

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My only addition to the motion would be that these should be Canadian-determined procedures for distributing drugs and that the Canadian branch of the drug company should be able to make its own independent decisions about the release of drugs without being beholden to the policies of international offices.

[Translation]

Mr. Pierre Brien: Thank you.

My next question is to Mr. Paquet from the economic commission of the Montreal Urban Community. You say in your brief, and you touched on it briefly at the end of your presentation that you would like to see patent protection restored so that Canada would have the same standards as other countries.

When patent protection was increased, the pharmaceutical industry was required to meet certain requirements, and, to all intents and purposes, it has done so. If, patent protection were to be restored, as you suggest, might we expect some additional commitments from this sector regarding R&D investments for other matters? Perhaps the pharmaceutical companies might make a more specific commitment in the area of basic research. Do you think that in return for getting what you want, we would be entitled to impose some specific requirements on the industry?

Mr. Paquet: When we supported the bill in 1993, we set out certain requirements regarding controlling drug prices and reinvesting at least 10% of the profits in R&D. We have seen that these promises have been kept. The industry is investing approximately 12.5% of its profits in R&D.

Ideally, if the period of patent protection were the same in Canada as in the United States or Europe, namely 14 or 15 years or genuine protection, we could require an increase in the percentage of profits invested in R & D, particularly in basic research, so that new products continue to come on stream for the treatment of new diseases.

[English]

Dr. Rachlis: I just wanted to mention that I believe there may be an error in your presentation, if I may respectfully point it out. You have claimed that generic manufacturers do not fund research and development to the same extent as do the brand-name companies. Although the study was done for the CDMA, a Price Waterhouse study of September 1996 claims that the CDMA member companies spend an average of 13% of sales on R and D, which would be approximately the same figure as for the multinational brand-name companies.

[Translation]

Mr. Pierre Brien: Mr. Paquet, the problem raised by the information you have provided the committee is that Patented Medicine Prices Review Board does not have access to the R & D audits conducted in the generic drugs industry. That causes a problem to us as to the credibility of the figures advanced for R & D investments by the generic drugs industry. But we can come back to this later.

In Quebec particularly, there are fairly generous R & D income tax credits. Generally, the legislative framework is quite favourable to the drug industry, and could perhaps be even better. However, given the international situation, if our main objective is to retain or create jobs in the R & D sector, is there not a danger that drugs may be manufactured elsewhere, once they have been discovered here?

In other words, we're investing a great deal to support R & D, and subsequently, once the discoveries have been made, the product is manufactured outside the country. Consequently, we end up importing the drug. We have a trade balance in drugs, despite all the support being provided. Have you thought of this aspect of the situation? Would you have any recommendations to improve the situation regarding manufacturing as well?

Mr. Paquet: I think the main point we wanted to highlight this morning is that the jobs created by companies involved in R & D are much better-paying jobs for our young people. Will industries manufacture their drugs elsewhere at a lower cost because we have promoted R & D here? I don't think I can comment on that. I don't think such a link can be made.

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In 1983, brand name drug industries were leaving Quebec and Canada to do their research elsewhere. Since extension of the patent protection to 20 years, in 1993 Quebec and Canada have attracted investments from foreign drug companies. I need only mention one from Sweden, Astra Pharma, which came to Quebec just a few years ago, and Bio Intermediar, a Dutch company. Why did they come here? Because they were able to retain their intellectual property.

The issue for Canada and Quebec is to be competitive with other countries. We were not competitive in the past, and that is why companies were leaving in 1993.

Mr. Pierre Brien: I have another questions for Ms Toupin or Mr. Farrell. You left out a passage in your presentation regarding international commitments. You say it would be possible to return to a compulsory licensing system, and still comply with our international commitments. I would like to know whether this opinion was provided to you by someone with legal training.

We have heard from many people so far, but almost everyone uses the same analysis or the findings of a single individual. Do you have a different source? I would like more information about the basis for statement.

[English]

Mr. Farrell: Actually, I've seen two legal opinions from two different lawyers, and one opinion from somebody who has quite a bit of background in international trade issues. The one on international trade is by John Dillon. He's with the Ecumenical Coalition for Economic Justice. The second is probably one you're familiar with, and was by J.G. Castel. And the third was by André Ouellet, who gave a legal opinion to the Consumers' Association of Canada. All three of them agree that Canada has significant room to move in terms of its international agreements, whether you're talking about TRIPS or NAFTA. Certainly compulsory licensing is explicitly stated as a method governments can use to protect the public interest.

[Translation]

Mr. Pierre Brien: If we could not amend these international agreements, if we had to operate within the context they set out, and if we could not return to the compulsory licensing system, would you have any suggestions? If we were to conclude that what you suggested is impossible, and that we have to meet our international commitments, what would you like to see happen in that situation?

[English]

Mr. Farrell: Maybe I wasn't clear. I believe we can respect the international agreements and still implement compulsory licensing. I don't see a conflict there.

[Translation]

Mr. Pierre Brien: If there is one.

[English]

Mr. Farrell: If not, then there are certainly other recommendations in terms of extending mandates at the PMPRB in terms of controlling drug prices. I think that's something that would be quite easy to do.

[Translation]

Ms Toupin: May I add something? To come back to your first question, Mr. Brien, I think it is up to the government, as Dr. Rachlis said, to determine whether we have any latitude with respect to our international agreements, such as NAFTA. I think you are quite right; some say we do, but in the very near future, the government will have to decide how much latitude we have under this agreement.

Mr. Pierre Brien: I see. Thank you. I will come back later on.

[English]

The Chairman: Mr. Schmidt and Dr. Hill, please. Welcome to the committee.

Mr. Grant Hill (Macleod, Ref.): Thank you very much.

I'd like to direct my initial comment to Dr. Rachlis, if I could. As a physician, I know you want to have your patients reasonably treated with good quality pharmaceuticals at a reasonable price. You've talked about national pharmacare and national home care. Is there some jurisdiction anywhere in the world that has taxpayer-funded medicare, pharmacare, and home care? Can you point me to some spot I could look at that can afford those three things?

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Dr. Rachlis: You could ask others the same question. As far as I know, though, it would of course depend on how you define home care. For example, does it include all aids and tasks around the house? Certainly Britain, through the National Health Service, has a pharmaceutical program that has small user charges. It also has a home care program that is very excellent. That's one example I can think of. I don't know if you have anything else beyond that.

I think my main point is that both the National Forum on Health and others have pointed out that it would be really a no-brainer to have a national pharmaceutical program that would not cost more than what we're presently paying for drugs if we enacted it in the interests of Canadians instead of in the interests of the multinational pharmaceutical companies, which is mainly how the present program is really operating.

Mr. Grant Hill: I'd like to turn to Philip, who in his own hospital environment has just faced the likelihood of his Wellesley Hospital shutting down. That's an indication to me that our whole health care system is under threat. His institution has a good record, and he himself is going to be affected by this.

In light of the fact that medicare is under threat, in light of the fact that we are undergoing sever cutbacks in terms of federal transfers to medicare, is this proposal idealistic in the extreme?

Dr. Berger: Which proposal?

Mr. Grant Hill: The proposal to have universally funded medicare, universally funded pharmacare, universally funded home care.

Dr. Berger: You asked the question about which countries have those right now. In my view, the province of Ontario has them right now. Through our provincial plan and the Canada Health Act principles, we have nationally funded health services in Ontario where people receive medical services. We also have home care, which is generally available to anybody who needs it, at least where I work in Metropolitan Toronto. And we have a pharmacare type of system in Ontario through people who are on social assistance or through the Trillium program for those who work. It subsidizes largely people's expensive drug costs. So we have elements of all three right in place in Ontario right now, and it would be a very small step to complete it in Ontario and to complete it nationally.

You know, Dr. Hill, my view is that there are some things in life that are worth paying for. That's contrary to the view of a lot of provincial governments and the national government. I think it's worth paying for the comfort, safety, and security of the citizens of Canada, so that they can have access to drugs and proper home care. Is there not enough money? Is there enough money? It depends on one's philosophic view. I think there's plenty of money for all those programs.

I don't think it's necessary to reduce the taxes on the wealthy by taking away programs from the poor. If one has the philosophy that it's okay to take away programs from the poor in order to reduce taxes, then get rid of the social programs. That's not my opinion. I think there is plenty of money. There are plenty of the wealthy and affluent Canadians, including myself, who can afford to pay income tax to provide security and comfort to our fellow citizens.

I believe in income tax. I have no problems paying income tax. I like to pay income tax. I like to pay it so I can walk on the streets in Toronto and see fellow citizens being a little bit comfortable. That's my view. There's a lot of money, and it would be no problem to achieve national programs in any of the three areas you enunciate.

Mr. Grant Hill: To go back to my original commentary, if there is a lot of money, what's happening to your own institution?

Dr. Berger: What's happening is the Government of Ontario wants to reduce provincial taxes by 30% and has to find the money somewhere. Like others, that government is going after the weakest, poorest sectors of society.

I happen to live an area of Canada that has every disconnected group in the country living in it. Whether it's first nations people, single mothers, drug addicts - including rock stars or crack cocaine users - sex trade workers, a huge number of refugees and immigrants from other countries, large numbers of people with mental illness, large numbers of people from the correctional services, lots of kids in the street, those people don't have political power. There seems to be an unfortunate Canadian tradition of going after the people who have the least influence and power, in order to benefit the middle class and the upper middle class.

There is plenty of money. The evidence is that my institution is being closed because it has no power, and the Premier of Ontario somehow has to find a way to achieve a 30% tax reduction. If there was no need to achieve a 30% tax reduction, there would be plenty of money to take care of everybody. As a citizen of Ontario, I'm prepared to forgo that tax reduction. I'm kind of ashamed of it, to tell you the truth.

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Mr. Grant Hill: Have the federal transfers from the Liberal government had any impact on this decision in your hospital?

Dr. Berger: I think you'd have to ask the Premier of Ontario about the federal transfers. All I know about is what's happening to my hospital and all I know is that what happens in Ontario hospitals is under provincial jurisdiction, not federal jurisdiction.

Mr. Grant Hill: Once again, have the federal transfers that have been reduced substantially for Ontario had any impact on your hospital?

Dr. Berger: As you know, Dr. Hill, the federal government does not fund hospitals in Canada. The provincial governments fund hospitals in Canada. And in my view, people and governments are responsible for their own behaviour.

If the Government of Ontario closes hospitals, it is responsible for its own behaviour. It is the only government that has the power to shut down hospitals, period. In my view, bringing in the federal government is somewhat irrelevant when it comes down to who is responsible for shutting down hospitals.

There are many influences on the province of Ontario as it determines how to achieve its tax reductions and contain costs. Maybe that's how you should phrase your question. One influence might be the reduction of federal government transfer payments, but I can tell you that another major influence is this political objective of reducing taxes. I suppose there are other influences on the provincial government as well.

Mr. Grant Hill: Finally, would anyone like to make a comment on free drugs as far as demand is concerned? What happens when pharmaceutical products are free and are considered free? What happens to demand?

The Chairman: Dr. Berger.

Dr. Berger: This is a mythology that drugs are free if they're paid for by the state. They're not free. Those drugs are paid for through taxes and through revenue from the citizens. To go and promote the view that drugs are free is an absolute misrepresentation of fact. They're not free. They're paid for by all citizens who pay taxes.

Secondly, as Dr. Hill and Dr. Rachlis both know, the vast majority of citizens who take drugs do so on the recommendations of their physicians. I certainly hope that physicians would continue to maintain proper, scientifically sound and ethical conduct in relation to recommending therapy. My view is that it shouldn't change anything, as long as doctors are doing their jobs, and as long as they are uninfluenced by the pressures of the pharmaceutical industry and only influenced by peer-reviewed, published articles and scientific journals and by independent sources of information.

The Chairman: Thank you, Dr. Berger.

Dr. Rachlis.

Dr. Rachlis: I just want to make the comment, again, that the user charges for drugs.... You can only get a prescription drug from a physician. I would be concerned about bringing in an open-ended drug program in the current environment.

The National Forum on Health has highlighted some of the tactics that could be used to implement a first-dollar coverage for prescription drugs in this country, which would include such tactics as the reference-based pricing strategy of the B.C. government, highlighting that there are many different ways of doing reference-based pricing. It can be done badly and it has been done badly in some jurisdictions. The way it's being done in British Columbia has resulted in approximately $40 million worth of savings in the first year.

If we adopted a national program of reference-based pricing and if we look towards more bulk purchasing of drugs - many of the other recommendations the forum has made - as well as changing medical practice so that physicians are no longer working largely by themselves on a fee-for-service basis, which provides an incentive for prescribing where the multinational pharmaceutical companies can spend as much on marketing their products to doctors as they do on research...in that environment, you're never going to have a drug program that works.

The national forum has highlighted that we need to change the way drugs are purchased, but we also have to change the way medical practice is organized. Then we can certainly afford a national drug program. It wouldn't cost any more.

The Chairman: Dr. Hill, thank you.

Ms Brown, you're leading the government side.

Ms Bonnie Brown (Oakville - Milton, Lib.): Thank you, Mr. Chairman, and thank you to all the presenters for broadening our view on this topic once again.

Dr. Rachlis, you said some really interesting things I don't have any background on, and I wonder if you could expand on them a little. You say that in the United States ``drug company representatives are barred from direct interactions with individual doctors''. How has that been accomplished? Increasingly that's happening in the United States.

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Dr. Rachlis: That's right. As you know, the United States, for better or for worse, has increasingly had its health care system reorganized according to something called ``managed care''. I say for better or for worse because some of the better examples, such as the non-profit group health cooperative in Puget Sound in the Seattle area, or the Kaiser Permanente system of clinics, have a long tradition of trying to provide good health care using the most appropriate methods of group practice and interdisciplinary teamwork.

In those facilities, some of which I have personally visited, because they believe that most drug company marketing is of no benefit and can be detrimental to the practices of physicians they only allow drug company representatives to come on site if they are specifically given an invitation. If a drug company representative comes onto one of the group health cooperative Puget Sound sites, for example, without being invited, the company risks being barred and losing access to that particular market.

Those large health organizations tend to deal at the level of senior scientist to senior scientist when they're looking at which drugs are going to be listed on the formulary of the group health maintenance organization. That's the way, I think, we should be looking increasingly in Canada. There's no reason we can't ban all marketing of pharmaceutical products. I think that's something that should be done. I think it should be the senior scientists and physicians of the province or of those health organizations that deal with the pharmaceutical industry. Again, they should be dealing with pharmaceutical industry scientists and physicians, not the marketing people.

Ms Bonnie Brown: Thank you. You also say, and this idea has been raised by other witnesses, that the biomedical research agenda should be set by publicly accountable bodies, that it's an inappropriate role for drug company executives. Is there a current body in Canada that you think might fulfil that role, or would we have to create a new one?

Dr. Rachlis: I've given some examples, such as the MRC and the SSHRC. But I think I would also highlight what some other people have said in the last few years, which is that if we increasingly want to focus our research more on social factors that affect illness and social interventions, then we might consider the development of a special social science health research funding body, which would be separate from the SSHRC and the MRC. Like some others, I have some concerns about the MRC moving into that area of population health with more of a biomedical focus, but that's perhaps neither here nor there. There are existing research bodies the money could go to.

Ms Bonnie Brown: Thank you.

Dr. Berger, first of all, thank you for the work you've been doing and for being so frank with us today. I found some of your presentation to be quite shocking when you were speaking about the network meeting. It's very shocking.

You also say in your presentation that the Department of Health has never enforced the advertising provisions of the Food and Drugs Act. I'm afraid I'm not familiar with those provisions. Could you give me an example of a provision or a rule in that act that is being broken on a regular basis?

Dr. Berger: The term ``advertisement'' is defined in section 2 of the Food and Drugs Act as any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device. Every single AIDS drug would fall under that definition.

So what drug companies in Canada do, which is also done extensively in the United States, is that when there is some minor research, and often it is minor, the company will organize a press conference, sometimes several times, on the same finding. Also, when a notice of compliance is issued, it will organize a press conference. And it makes a big brouhaha about the particular finding or the notice of compliance under the cover of informing the public.

In fact, the effect it has on patients - and I know this because I hear it from my own - is that they think they should then be taking the drug right away. Phone calls start coming into our offices, and people start dropping in. Every time there's a press conference, it causes a great deal of angst in the community. People think they should run in and get the drug. That to me is promoting the use of the drug. It bypasses the physician-doctor relationship, and it makes it very difficult for us to counsel people when we're trying to counter the promotional activities of the drug companies.

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I once did publicly ask a representative of Health Canada - I'm sorry, I forget her name - about a year and a half ago at a conference, ``Why are you not enforcing this provision? Why are you not prohibiting these press conferences that are promoting drugs?'' The answer was, ``Well, it's a grey area''.

But I can tell you there has not been one press conference - which to me are equivalent absolutely to advertising - that has been stopped by Health Canada. Those are the examples I can give you.

Ms Bonnie Brown: Just a summary question, then, to both Dr. Rachlis and Dr. Berger. The impression I'm getting from both your presentations is that the pharmaceutical companies are driving the agenda, no one is controlling them, and that in a sense the government of Canada has stepped back from responsibilities it used to take seriously, and we should strengthen the role of government in this whole field. Does that summarize it?

Dr. Berger: I think that's a fair representation. My own view is that the duty of the state is to balance the public interest against the private rights of individuals and corporations. That happens in all industries - transportation, insurance, energy. The state has to protect the public from monopolies and from unfettered power of corporations, without trampling too much on their individual rights.

But I think the Canadian way and method of thinking is that it is okay to take away certain rights - even entrepreneurial rights - if one can justify it to protect the public interest. If there has ever been an area that is justified and in desperate need of control and regulation, it's the wild west - and I don't say that out of disrespect to Alberta or western Canada - the wild west type of behaviour of the industry. It is absolutely uncontrolled.

Unfortunately, it's very difficult for physicians and AIDS activists in the area I work in to speak out, because if they speak out they are disciplined by the industry in the form of withdrawal of funding.

I would just finish off quickly about the original two points raised with Dr. Rachlis.

One area where the United States is far more advanced than Canada is in the disclosure of commercial support from companies by clinicians and scientists. Clinicians and scientists in the United States are required to disclose by many universities and leading medical journals, including the New England Journal of Medicine, any type of financial affiliation or support these scientists and doctors receive from the industry, and it's published right in the medical journals.

Secondly, on the point of who determines biomedical research, it's well known in the AIDS area that there are promising anti-AIDS drugs within the confines of drug companies that those companies have chosen not to develop because of marketing considerations. This opinion has been voiced by leading researchers, who I disagree with sometimes about the industry, but they have said these drugs are not being developed because the sales reps don't think they'll sell, basically.

It's a shame, if there's a promising drug, that it's solely entrepreneurial and profit motives that determine whether it's going to be available to the people or not. If the companies say there should be an equal partnership, why aren't the citizens at the boardrooms determining which drugs should be developed?

The Chairman: I'm going to ask the committee for guidance here. I've just been informed that the vote is taking place more quickly than I realized, and there is a preference that the committee suspend and go back to the House for the vote.

We can reconvene at 10:40, or if members feel their major questions have been answered, we'll thank the witnesses. I'm in your hands here.

[Translation]

The vote will be held immediately.

[English]

We could return at 10:40 at the earliest.

Mr. Joseph Volpe (Eglinton - Lawrence, Lib.): Mr. Chairman, I wonder if we could explore the possibility with the opposition parties of pairing, and carrying on with that.

The Chairman: Sorry. The instructions were, as they say, ``clear-cut''.

Mr. Joseph Volpe: Okay. May I suggest, then, that we keep the witnesses here for when we come back?

A voice: Yes.

The Chairman: Yes? Do the witnesses mind? We have the vote, but we'd like to spend more time with you. We'll be back at approximately 10:40. I can't guarantee it exactly, but we'll say about 10:40 and we'll continue our work.

The committee is suspended until 10:40 for a vote, and we'll come back as soon as we can.

This is our life, folks.

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The Chairman: The committee will resume its work. I'd like to thank the witnesses for their patience as we go through our parliamentary life. It's very disruptive at times. It happens. My suggestion to the committee is that we do another five-minute round for each of the three parties.

Pierre's coming in. I'm going to ask him whether he's ready. If not, I'll turn to one of the government members.

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Before we resume with the witnesses, there are three motions we have to get done while we have members here. This will take two minutes of the committee's time. These have all been discussed with committee members.

It has been moved by Mr. Bodnar that the chairman be authorized, in conjunction with the clerk, to organize working meals to be paid for from the committee budget. This happens very infrequently, but I need the authority.

Some hon. members: Agreed.

The Chairman: The second motion, moved by Mr. Bodnar, is that John B. Dossetor be hired as adviser to the committee during its review of section 14 of the Patent Act Amendment 1992. His résumé has been circulated to committee members.

Some hon. members: Agreed.

The Chairman: The third motion concerns a change in the membership. This was so moved by....

[Translation]

Mr. Claude Bachand (Saint-Jean, B.Q.): I nominate my colleague, Mr. Brien.

The Chairman: Moved by Mr. Bachand that Mr. Brien be elected Vice-Chair of the committee.

[English]

Would you like to record your votes or not? I just wanted to make sure. Let's have a roll call to make it appropriate. This is about the replacement of Nic Leblanc, who is no longer a member of the committee.

I don't know what happened. What happened to him? He was here every day and then.... His heart's in the right place, but not his vote.

Motion agreed to: yeas 7; nays 3

The Chairman: Welcome to the steering committee. Thank you very much for being here.

The business is finished. Let's return to the witnesses again. For those who are waiting for the next round table, we'll start it as soon as we finish with these people, who are very good witnesses. We just had a bit of a disruption.

I suggest to the committee members that we do another round of five minutes and then see what the will of the committee is.

Mr. Joseph Volpe: Mr. Chairman, I think the questioning ended with Mrs. Brown posing a question. I think perhaps we'd allow that question to be finished by the panel. I don't know whether they did or not.

The Chairman: Mr. Berger, did you or Mr. Rachlis finish the response?

Dr. Rachlis: She asked both of us the question.

The Chairman: Go ahead.

Dr. Rachlis: The question, as I understood it, was about whether or not we had concerns about the power of the pharmaceutical industry in this country. I think that the bottom line of my presentation - and you've probably heard it from Philip and others as well - is that the balance has swung much too far. You can tell by the presence in this room and presence in your offices of representatives of multinational pharmaceutical companies. They're tenacious. They have far more resources than government - any government in this country - to deal with these issues.

I'd say that the power of the pharmaceutical companies in Canada, despite the good they do, has endangered and is endangering our health system and is poisoning public discourse.

I think you have to ask the Canadian Medical Association yourself. You should demand that they appear here. Ask them why they have not asked to appear. I think they are frightened to appear and sit in the room and possibly criticize the drug industry, for fear that they may lose, for example, advertising in their journal or whatever. I don't know what their reasons are. I find it appalling that they're not appearing.

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The power of the pharmaceutical companies has poisoned the public debate on pharmaceutical issues. I would say that you as a committee, particularly government members, have the opportunity to rebalance the equation. I think you have the responsibility to champion the rights of the people of Canada, rather than the interests of the multinational pharmaceutical companies.

The Chairman: Thank you.

[Translation]

Mr. Brien.

Mr. Pierre Brien: Mr. Paquet, I recently read in some economic journals that there had been some studies of the international competitive position of various Canadian provinces in the area of drug products. Could you tell us what the current position of Montreal and Quebec is in the pharmaceutical sector. In your view, what would be the impact of returning to compulsory licensing with four or six year's protection?

Mr. Paquet: The impact would probably be catastrophic, at least for Quebec. The greater Montreal region and even Canada generally have attracted foreign investments in the pharmaceutical sector strictly because of the passage of Bill C-91 in 1993.

In the pharmaceutical sector, Quebec and even Canada still hold a dominant position, particularly in the research and development of new products, as does the generic sector. Protection of intellectual property was introduced in 1984, 1987 and 1993 strictly because drug companies were leaving Quebec and Canada to do their research in the United States.

Renewed protection of intellectual property in 1987 and 1993 enabled us to create new industries in Quebec and Canada, particularly in biotechnology. In the last ten years, the biotechnology sector has developed incredibly. It represents the future of health in Canada.

Health is more than just the cost of drugs. The cost of drugs is a minimal variable in the cost of health care. If new drugs had not been produced, health care costs would have been much higher than they are. I'm a general practitioner. Thirty years ago, we did a great many gastrectomies, as a treatment for ulcers. As you know, today, we no longer operate in such cases, because of the new drugs that have become available. This results in reduced hospital costs.

If there were no companies doing research to develop new products, generic drug companies would obviously be unable to produce them, and science would not be advanced. We have made progress because of research and development. There has been a great deal of talk this morning about the social cost of drugs. I think each province has a role to play in the social aspects of health. Each province plays this role, but we should not try to reduce research and development activities, in my opinion.

Mr. Pierre Brien: I have a question for Mr. Berger. You spoke a great deal about the relationship between companies and doctors with respect to the information provided to them. I would like you to explain what you mean. If ever there were an independent body that was supposed to provide information, and if contacts between the industry and doctors were restricted, we would run the risk of having this single source of information becoming a monopoly. I always have somewhat of a difficult time with that. So what would you recommend to help us get around this problem?

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[English]

Dr. Berger: Before I answer, I'd like to indulge the chair for one minute by saying there's a group of students from across Canada here to observe our Parliament. I just want them to know, since they seemed to think I was a government employee or an MP, God forbid, when I came in, that in the job description of every citizen is the responsibility to hold government accountable for its conduct and also to teach legislators. That's the only reason I'm here today - as an ordinary citizen, not as an official of anybody. I hope you'll take that lesson back home with you, wherever you go back to.

I think you might have misunderstood my position. I didn't propose limiting contact between doctors and physicians. What I'm discussing is improper conduct in the relationship between doctors and physicians. I think it's perfectly fine for representatives of the industry to engage physicians in discussing future clinical trials, for example, or distribution of drugs, etc. But the company should not be present in an environment and discussions when the results of those discussions will directly benefit the companies financially. That's got nothing to do with limiting contact, or with the prevention of dissemination of information.

The other thing the committee should know, and all citizens should know, is that the most reliable information available is that which is published in peer-reviewed medical journals. Peer review means that manuscripts that provide findings of research are reviewed by independent reviewers - independent from the companies and the researchers to make sure the methodology is correct and the results are verifiable and reliable. It's peer review that protects the public interest and is the best source of information. There is no conflict of interest.

The American medical journals and some British medical journals have a policy in force that requires authors of articles to disclose their financial relationships with the industry.

If you look at the July 10 Journal of the American Medical Association from 1996, during which recommendations for anti-AIDS therapy were published, there is a long list at the end of the article about the involvement of 12 of the 13 authors with the industry, with two of the authors owning stock in drug companies about whom they're writing recommendations for the public, and the other 10 having received all sorts of money from drug companies. But at least it was publicly disclosed, so the readers could make their own judgment about the reliability of those recommendations. None of that is limiting contact. What I'm arguing for is public disclosure, so we can make our own assessments.

[Translation]

Mr. Pierre Brien: Thank you.

[English]

The Chairman: Mr. Schmidt in this round, is it?

Mr. Werner Schmidt (Okanagan Centre, Ref.): Thank you, Mr. Chairman.

There are a couple of questions, and they have to do with the unholy alliance, as I think you referred to the relationship between physicians and pharmaceutical companies. Could you explain a little more fully, first of all, what is the alliance that you were referring to, and what is unholy about that alliance?

Dr. Rachlis: The alliance I see is that drug companies provide grants to physicians for research and they provide money to physicians in other ways, as Dr. Berger has outlined. In return, drug companies are looking for from physicians - and particularly specialist physicians who are seen as leaders in their areas - the endorsement of their products.

I call this an unholy alliance because I feel that the medical profession - like other professions in this country, but perhaps more than most - holds the medical knowledge that physicians have as a public trust. It's not our private property, it's a public trust. And we breach that trust when we are prepared to take money from private industry in return for product endorsements. That's my concern.

I feel this has been abetted by the current environment where government has cut back on its own commitments to research, at least up until recently, forcing many physicians and scientists to look elsewhere for money. This has been a perfect set-up for physicians to become beholden to the drug industry.

Again, I would highlight that I'm very, very upset that the Canadian Medical Association is not going to be testifying at this meeting. I think this committee should do everything it can to ensure that they come here to answer that question themselves.

Mr. Werner Schmidt: May I, just to be sure I completely understand exactly what it is you're saying.... Are you saying that physicians should not take money from pharmaceuticals for doing research?

Dr. Rachlis: No. But I'm saying -

Mr. Werner Schmidt: What are you saying?

Dr. Rachlis: There are a whole number of separate policies that I feel need to be enacted. But on that issue, I feel that instead of the drug industry using its money to sponsor research to in some ways ``buy'' physicians, that money should go through public granting agencies like the Medical Research Council so that physicians receiving the money would not feel beholden in any way to the industry.

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Mr. Werner Schmidt: That means you are saying pharmaceutical companies should not pay physicians. They should give this money to some kind of other group before it gets to a physician of some kind. Is that what you are saying?

Dr. Rachlis: The National Forum on Health has made similar recommendations - that the money should go to peer-review organizations for distribution. The money could come from pharmaceutical companies, I suppose, but indirectly. I'm concerned about the direct grant support from drug companies to physicians, because I feel that provides great opportunies for corruption.

Mr. Werner Schmidt: Okay, so the indirect association is fine, but the direct association is not good. Is that the point you're making? I really want to understand this, because this is a very significant point you are making.

Dr. Rachlis: Yes, I'm saying I would prefer that the research money from pharmaceutical companies go through peer-review organizations such as the Medical Research Council. I hope that's clear enough.

Mr. Werner Schmidt: So that's the specific situation.

Dr. Rachlis: Yes.

[Translation]

The Chairman: Mr. Paquet.

Mr. Paquet: I would like to say something. Saying that pharmaceutical companies buy doctors is a very serious thing. These are very serious accusations. I'm a doctor in private practice. Such an accusation strips the canadian medical profession of its sense of criticism, of its sense of honesty and integrity. I find such statements to be excessively disgraceful.

You don't ask a plumber to conduct medical research. Basic research as well as clinical research must be carried out. Who can do this?

By subsidizing research centres, whether they be at the University of Toronto, at York University, in British Columbia or in Montreal, at McGill, are the companies, through these actions, buying the doctors who conduct this research so that they will say that this is a good product?

We know that it takes an investment of nearly $500 million to produce an effective product. Researchers are doing basic research work in the companies and in the research centres. In other centres, there are research organizations under contract. At least 156 centres do research. Doctors are not the only ones who are in these centres. Therefore, to say that the companies are buying the doctors is going much too far, in my opinion. There are certainly still some honest people, regardless of what their profession may be, who still have a critical mind and a sense of integrity. I do not accept such statements.

At any rate, we are here today. What is the primary objective of this exercise? Should we maintain this intellectual property? Today we are reviewing Bill C-91. Since its adoption four years ago, have the companies kept their promises with respect to the investment and price control criteria? We could say that the answer is yes.

If Canada wants to become competitive internationally and create wealth in our country, it must realize that investments of $500 million in research create jobs.

What is the problem facing young people in Quebec and in Canada? We don't have any jobs for our young people. We must not go back to the days of 1987 when our research centres headed for the United States. We are capable of building these research centres here. How many jobs have been created? Seventeen thousand three hundred people work in Canada in the patented drug industry, compared with 5,300 people in the generic drug sector.

In Quebec, 5,255 people work in the patented drug companies whereas 1,800 are employed in the generic drug sector.

[English]

The Chairman: Mr. Schmidt.

Mr. Werner Schmidt: I'd like to follow this up with the other part of this, which was that part of this unholy alliance had to do with the endorsement of particular products by medical practitioners. That's the other side of this coin. Exactly what is behind that statement?

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Dr. Berger: Dr. Rachlis or...?

Mr. Werner Schmidt: It doesn't matter, either one of you. You're both in the same area on this one.

Dr. Berger: Could you repeat the last part of the question, please?

Mr. Werner Schmidt: Why is the endorsement of a product by a doctor bad?

Dr. Berger: Why is it bad? I'll answer the question in the context I know, which is in the context of anti-HIV therapies, where many of these endorsements occur before a notice of compliance has been issued by Health Canada, the Government of Canada, which has a final word on instructions about how the drug is supposed to be used, indications, side-effects - everything someone has to be aware of. That's the protection of the public. That's where regulatory procedures come in place.

When a physician goes to an industry-sponsored press conference to promote a drug before it has been issued a notice of compliance, the danger is that it is only the view of the drug company that's being represented when the information is given. Often it has not gone through the process of peer-review publication in a journal or final approval by the Government of Canada. In my view, that's illegal activity, and the provisions have never been enforced. The risk is it's skewed, biased information from a self-interested party. That's why it's dangerous.

The second reason it's dangerous - and I think you have to know this is my personal viewpoint - is the emotional effect these announcements or advertisements have on people with terminal illnesses.

I had a cousin who died of AIDS about two and a half years ago. Three months after he died, another press conference by one of these companies comes out, about a life-saving AIDS drug - front-page headlines in The Globe and Mail. Another relative of mine phoned me up and said it's too bad this man couldn't have lived three more months; he could have had the drug.

That's the effect that has on people, even though the drug would have been useless for him. The protection the public gets from preventing that until the drug is formally approved is that you don't get that type of emotional effect on the people; you don't create desperation in people's hearts.

Mr. Werner Schmidt: I'm sorry. I want to clarify, then, that really your objection is not that the doctor endorses it but that the doctor does so illegally, that somehow there's something happening here. The Health Protection Branch clearly approves or disapproves of drugs, and you certainly wouldn't criticize that if a doctor supports a drug after that has happened.

Dr. Berger: Well, I would.

Mr. Werner Schmidt: Oh, you would do that too.

Dr. Berger: Yes, I would.

Mr. Werner Schmidt: So the Health Protection Branch doesn't make any difference?

Dr. Berger: No, I didn't say it didn't make a difference. The Health Protection Branch ensures that the proper rules and indications governing the prescribing of drugs are in place. That's their job, and I support that. But I want to read to you, and especially my colleagues on the right, the first statement of the Canadian Medical Association.

The Chairman: You made your point and I think that's sufficient, because I want to make sure Mr. Murray has a chance for his questions.

Mr. Murray.

Mr. Ian Murray (Lanark - Carleton, Lib.): Thanks, Mr. Chairman. I have one quick question, and then I have to leave and go to another committee.

Both Mr. Farrell and the National Anti-Poverty Organization brief recommended that priorities for health care research should be established by the federal government.

Dr. Berger, you were suggesting that a portion of the profits of pharmaceutical companies should be -

Dr. Berger: Wrong doctor.

Mr. Ian Murray: Oh, it's Dr. Rachlis. Anyway, a portion of those profits should be funnelled through a government body for research.

We've heard in previous testimony that it costs anywhere from $200 million to $500 million to develop a new drug. Also, the nature of research and development in multinational companies today is that the R and D is not necessarily all done in one lab in one country, that they can go on 24 hours a day, essentially, around the world as various researchers work on new products.

So my concern really is that it would be in Canada's interest, considering the enormous costs of developing new drugs, to have a government body deciding what the priorities are for health research in Canada. In other words, how much could we hope to accomplish as a country, considering these enormous costs and the fact that R and D is going on around the world, which we can all benefit from?

Dr. Rachlis: I want to say that the $500-million figure is really completely erroneous. It's almost pulled out of thin air.

You've had an excellent analysis in the brief that was presented by the Canadian Health Coalition, in association with the Medical Reform Group, which has analysed this, which shows the way that figure has been puffed up to at least twice and probably three times or more what it really is.

Secondly, you're talking about the industry committee. You can't just look at the few thousands of jobs that are involved with the pharmaceutical industry, because to other industries in this country, drugs are not a revenue; they are a cost.

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It is my understanding that last year Industry Canada and Health Canada sponsored a study that was done by KPMG, which identified that every Canadian city had lower costs of doing business than every single American city, and that the two main reasons were our public health care program and our public pension plan, both of which are under serious attack.

If we wanted to improve the competitiveness of our industry in this country, we would do something about the cost of drugs. That would benefit most of the industry in this country, which is not involved in making pharmaceuticals.

Mr. Ian Murray: With respect, Dr. Rachlis, you're not addressing my question. My question is: if you had government-directed research in Canada, then how would you...? Again, it takes years, and this question of how much it costs for R and D also takes into account the fact that there are many failures along the way. You don't hit a home run every time you invest in research and development.

Dr. Rachlis: I'm not saying that the pharmaceutical companies should stop doing research; I'm saying that some of their profits should go into supporting public research so that we can regain public priorities for our research. I'm not saying this should be directed by Health Canada; it should be directed by such arm's-length organizations as the Medical Research Council.

Mr. Ian Murray: Okay, Mr. Farrell, do you want to make a comment?

Mr. Farrell: Yes. I'm not suggesting that the Government of Canada completely take over research into drugs. I don't think that's what we're talking about.

Mr. Ian Murray: But I'm concerned about the amount of money that would be required to do credible research in the same areas as pharmaceutical companies.

Mr. Farrell: No, I think Dr. Rachlis has made a good point, that what we're looking at is using whatever portion of those profits we're going to siphon off to establish priorities for research. I think that's the way I see it being used.

What I'm concerned about is that there's a lot of talk about how we need to preserve jobs or we need to maintain our competitiveness. Although I believe those are good goals to have and I don't have a problem with it, at the same time I think there is the public interest that we do have to consider. It seems pretty clear that Bill C-91 is not striking the right balance between those two. I think we need to do something to move it over so the public interest is protected a little bit better.

Mr. Ian Murray: Okay, I'm going to have to run. I'm sorry, but thanks, Mr. Chairman.

The Chairman: Thank you for answering, Mr. Farrell.

Mr. Volpe, I'll turn to you, but can you possibly look at the clock and aim for 11:30 or so?

Mr. Joseph Volpe: I'll try to be very brief, Mr. Chairman. Thank you very much.

Thank you to all of our witnesses, not only for your patience in the interruption we've had, but for a very lively presentation.

I think there are a couple of positions that I might define as almost diametrically opposed, and I want to make a comment and elicit a response, if you will.

I find the language that's coming from the group from Montreal really interesting. I heard last night, tonight, and others, words like catastrophe, désastre, and so on, and I wonder whether we're beginning to raise the level of language to a point where we're missing a point.

If I can bring you back to the question of patents, I wonder whether the most important dynamic with respect to investment in some of the companies that you would support comes from government policies with respect to investment - and I refer specifically to an article in The Globe and Mail that's looking for the federal government to change its rules on RRSPs and allowing investments to exceed the limits for overseas investments; and secondly, whether in fact your main focus of concern is, or should be, the Quebec formulary and the way it impacts on company decisions to locate for clinical testing, for clinical research and development and for manufacturing, and whether in fact you would agree with some of the people who came before the committee last night who seemed to be from the profession, number one, specifically, that the best source of funding for all basic research would be in fact the Medical Research Council and not any industry-associated funding source.

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And finally, Dr. Paquet, you heard this morning - and we heard this yesterday and on other days as well - that one of the basic problems for us in the health care system, with respect to costs only, is that the prescription habits of doctors account for something like a minimum of 15%, I believe, in one study, of all costs attributed to prescription drugs.

Looking at our own figures of about $6.8 billion, 15% of that brings us to around $900 million, closer to $1 billion. If that $1 billion - let's use that just as a benchmark that we can play with - of costs is directly attributable to the prescription habits of professionals, the people we trust, the people we know can understand the system, should we be looking at that rather than at patent protection? If we reduce that cost, would we not be able to convert that $1 billion into a different kind of investment?

[Translation]

Mr. Paquet: Should doctors change their prescription practices? I don't think that this is the main factor. I do not believe that doctors start off by prescribing drugs for the sake of prescribing drugs, or give out prescriptions for a second or third time. Personally, I do not believe this is so. Some patients may abuse drug prescriptions, but it is very difficult to say, with any accuracy, what this percentage is.

We have to go back to the issue of cost. You talk about the cost of drugs in one province compared to the others, but there is a direct cost of the drug. If the arrival of a new drug on the market can reduce the number of days of hospitalization or may even avoid hospitalization and operations, and this is occurring more and more often in the provinces, our health system is the beneficiary. This is what research into new drugs has done.

Mr. Joseph Volpe: I asked you for some exact statistics.

Mr. Paquet: I do not have any statistics.

Mr. Joseph Volpe: None at all?

Mr. Paquet: No. I can tell you that 30 years ago, every year at least 10 of my patients had to undergo a gastrectomy for bleeding ulcers, perforated ulcers that would not heal. None of my patients have had to undergo a gastrectomy over the past 10 years, because we have drugs that treat and heal the ulcer without complications.

What is the cost of operating on a person's stomach? The individual no longer has his stomach. Thirty years ago, we didn't have any drugs to save him. You must understand this. You know that we used to hospitalize people for pneumonia. Today, we no longer need to hospitalize people; they can be treated at home with new drugs, with antibiotics, providing that there is no abuse. I don't have any figures, but I know that, in practical terms, these are the facts.

When you get right down to it, our goal today is to determine whether or not we should revise Bill C-91 further to what was said in 1993. In my opinion, the pharmaceutical companies have kept their promises. The generic drug industry is not monitored by the Patented Medicine Price Review Board.

[English]

The Chairman: We will hear a final comment from Dr. Rachlis and then that's it.

Dr. Rachlis: Very briefly on this point, there is a lot of evidence to show that unfortunately my colleagues and I prescribe drugs the way drunken sailors spend money.

I refer you to just one of many articles by Dr. Robyn Tamblyn from Montreal, one of Canada's best-known researchers. An article in the Canadian Medical Association Journal in 1994 looked at a scientific sample of all the elderly persons in Quebec over a one-year period. Over 50% of these patients experienced one or more events of high-risk prescribing during that calendar year.

The Chairman: Thank you very much for the testimony. At times it differed, as you can tell, and at times it was controversial. But we have to get people who have different points of view around the same table. It's very important for the committee to hear viewpoints side by side and understand what we're dealing with here, because it's not an easy issue to resolve.

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[Translation]

I think that Mr. Brucel is taking a photo.

[English]

If the committee members will indulge us, I'm going to suspend the committee while the new people come in and allow Monsieur Brucel to prove to the people of Montreal that he actually came to Ottawa.

Voices: Oh, oh!

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The Chairman: The committee resumes its consideration of the review of Bill C-91. I'd like to welcome everyone to this round table. I invite you to make a brief opening statement and then I'll allow the members to ask you questions and engage you in debate.

Without further ado, I'll turn to David Alper from Project Genesis. Welcome, sir.

[Translation]

Mr. David Alper (community organizer, Project Genesis): Project Genesis is a community organization in the Côtes-des-Neiges, in Snowdon, a multicultural and very poor neighbourhood of Montreal. We provide advocacy services. We see thousands of people, especially seniors, newcomers, people who live below the poverty line and a lot of unemployed.

Every day we see dozens of people who, and this is happening more and more often, have no access to health care and social services. We believe that part of their problem stems from Bill-91.

We have some expertise on Quebec's drug insurance legislation, which came into effect on August 1st 1996. Since then, we have noted, almost on a daily basis, that more and more people from our neighbourhood simply no longer have the means to pay for their drugs and to eat. Moreover, an individual from our neighbourhood has accompanied us today and will be testifying later on.

We see that the cost of drugs is extremely high. There are fewer and fewer jobs. We have even seen that there has been a decrease in the level of employment in the pharmaceutical sector. When you talk about jobs, you must be very circumspect. You also have to look at the cutbacks in health sector jobs. We know that, in Quebec, approximately 15,000 jobs are going to disappear in the health sector. We see that there is almost no control over the cost of drugs. Every day people tell us: I'm no longer taking my drugs or I'm cutting on my food intake, for me or for my children.

We have even done a study on this topic. In our neighbourhood alone, we documented dozens of cases where people had either partially or totally stopped taking their drugs, and in ten cases ten people had to be hospitalized.

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In the United States, where a similar law was passed in the state of New Hampshire, a study showed that the long-term cost of the health system increased dramatically when low income people were forced to pay for their drugs when in fact they did not have the means to do so. As a result, this law was overturned.

Consequently, we don't think that we can make any savings on the backs of our citizens. We feel that access to drugs must be recognized as a right to help, like any other fundamental right.

We feel that C-91, with the protection it gives to the pharmaceutical companies, constitutes an obstacle to this right and that the government must amend this law. It is a question of political will and social justice, and the government absolutely must diminish the protection given to pharmaceutical companies.

We also agree with the idea - moreover this was one of the recommendations - of a national drug insurance plan, but with one notable change. The primary objective of this plan must be access to drugs. In Quebec, this is not the purpose of the Act. Rather, it seeks to save money at the expense of the poorest citizens. In Quebec, two-thirds of the savings realized as a result of the drug insurance plan are made at the expense of the poor.

Accordingly, we think that Ottawa, together with the provinces, must introduce a national drug insurance plan.

Our final recommendation proposes controls for pharmaceutical products, not only for patented drugs but also for generic drugs.

The Chairman: Now

[English]

I'd now like to turn to Mr. Khatter from the Sandy Hill Community Health Centre. Welcome.

Mr. Kapil Khatter (Board Member, Sandy Hill Community Health Centre): I'm Kapil Khatter. I'm a family physician, actually, and I'm on the board at the Sandy Hill Community Health Centre. I'm here representing the community health centres of Ottawa-Carleton.

I'll just talk a bit about community health centres. We provide clinical and other health-related services through multi-disciplinary teams. We have a holistic approach that emphasizes disease prevention and health promotion. Most importantly, we are directed by and accountable to the community, so we get a lot of input in terms of what our communities need. As well, we are mandated to work for hard-to-serve populations: low-income families and their children, the homeless, isolated seniors, newcomers, etc.

Our concerns with Bill C-91 are that new drugs lack adequate price controls and that the 20-year patent makes these drugs that are unaffordable to many unaffordable for an extended period of time. In addition to that, there are regulatory mechanisms that hinder quick access to generic equivalents. As well, part of the goal of Bill C-91 was to increase pharmaceutical research and development, but studies are showing that much of that research and development is on ``me too'' drugs that are intended to increase profits and have little effect on health. They're not designed to improve the health of Canadians.

The impact on our communities that we're seeing is, for example, that the working poor and those with no health plan whatsoever cannot afford the newer medications. At times, when those new medications are the ideal choice, they may be getting less than ideal care. Because the new drugs are expensive, they can't be on formularies. The seniors and those on public drug plans, such as the Ontario Drug Benefit, have no access to those drugs.

As well, the largest rise in health care costs in Canada is the rise in the cost of drugs. This rise is a financial strain on all of us. It is a financial strain on our communities and on our ability to pay for medicare.

I have a couple of concrete examples from clinical practice. If you look at asthma, the steroid puffer, which is the older treatment for asthma - Beclomethasone - is $16 per puffer. The new drug, which is now the drug of choice and which physicians ideally would like to be able to give to everyone, is now $90, and is, not surprisingly, not covered by drug plans and won't be covered by drug plans for quite a while. If it's true that this new drug is the ideal choice and would perhaps prevent more hospitalizations, this will cost us more in the long term in general.

Another example is Finasteride, or Proscar, which is a drug that's used for treating prostate enlargement. It's $65 per month. Of course it is also not on drug plans, and it is not available free to seniors, who are the people the drug is intended for.

So you have a situation in which those who can afford to pay the $65 per month can have this drug that is intended to prevent surgery or to postpone surgery, whereas those who can't afford it have to have surgery with the complications and risks that come with that, as well as, once again, the cost to medicare and to society.

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Our recommendations, therefore, are: the establishment of a reference-based national drug plan that provides universal coverage for pharmaceuticals, brings pharmaceuticals under the Canada Health Act and allows us to have better control over costs. We want to see better control over drug prices, particularly the entry-level price. The entry-level price of drugs should reflect the cost of the development of the drugs and not merely the price the market will bear.

We want to see the government ensure quick availability and access to generic drug equivalents. We'd like to see better monitoring of the quality and effectiveness of the pharmaceutical research and development that is taking place in order to ensure money is not being spent on just token research but on research that is indeed of benefit to society.

Finally, we recommend that we work to create an unbiased information network on drugs and alternatives to drugs for all health care providers in order to reduce inappropriate prescribing caused by pharmaceutical advertising.

Thanks for the chance to speak.

The Chairman: Thank you very much, Mr. Khatter. That was a very clear opening statement, as was Mr. Alper's.

We'll now hear from Francis Arbour of the Ottawa-Carleton Health Coalition.

Ms Francis Arbour (Development Consultant, Ottawa-Carleton Health Coalition): We're also going to speak on behalf of the Ontario Health Coalition. That's what they've asked us to do.

The Chairman: Fine. Thank you.

Ms Arbour: The Ottawa-Carleton Health Coalition is a non-profit, non-partisan organization affiliated with the Ontario Health Coalition and the Canadian Health Coalition. Our membership consists of individuals and local organizations representing seniors, labour, low-income people, women, health care providers, students, academics and churches. We endorse the brief submitted to your committee by the Canadian Health Coalition on March 4 of this year.

Our goal today is to provide information and stories about the local effects of Bill C-91, so that the voices of citizens, at least in this region, are heard. We urge your committee to recognize that these anecdotes are evidence of policies and practice and that each one of these stories is one too many. Remember that every time politicians like yourselves get a letter, you multiply it by 10. So it is with these stories; we urge you to listen to these stories of how high drug prices are hurting ordinary Canadians.

A single mother of teenaged twins can no longer get preventative medication for their asthma through the provincial drug plan. The drug plan has delisted the number of drugs whose purpose is to prevent, rather than treat, a chronic illness. The province has stated that this change is due to the overall high cost of prescription drugs. For these teens this means that they can have the medication to treat an asthma attack once it has happened, but they are unable to prevent such occurrences. If it is serious enough to require hospitalization, the cost to the health care system of one such hospital stay would pay for more than a year's preventative medication for both of these twins. I won't go into the other costs, but obviously, if a teenager has an asthma attack, they can't do the things that teenagers want to do.

Another story is that of a woman with breast cancer who knows that a certain drug would decrease her discomfort. It is not available through the provincial drug plan. The reason given to her is that it would not cure her disease, only mitigate its effects.

One person said to us, ``I cannot afford to pay my rent, and I have to wait three to seven years for subsidized housing. I'm suffering from chronic depression. Does the provincial government really need $2 a month from me?'' This is the prescription user fee that has been put in place because of the high cost of drugs.

Other parents have told us, ``Our daughters have cystic fibrosis. They require a lot of medication on a regular basis. But with the current cuts to social and medical services, these needs will no longer be covered. Our daughters cannot work full time in order to pay for their needs.'' The prognosis is very scary for these families.

The final story is that last December a hospital patient was told that there wasn't enough money in the home care budget to give her family enough assistance so that she could die at home. However, she was told that if she could see her way clear to survive until January 1, then there would be plenty of money to fulfil her last wish. This is incredible in a country like Canada.

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Today we have told you only a few of the many stories we are collecting about people who live in this region of Ottawa - Carleton. We would now like to draw your attention to several themes that have emerged from all of these stories.

First and foremost, for people on a low income, cost is the overriding factor in their decision to fill or to not fill a doctor's prescription. When people cannot afford to buy their medication, they must make extremely difficult choices. For some the choice is between the purchase of medicine or food. This is a no-win situation because poor nutrition is a contributor to ongoing poor health.

Second, some people choose to purchase only one of two medications they are prescribed, without knowing that they must be taken together in order to work properly. In fact, it may be dangerous to take only one drug, or it may allow a resistance to be built up in the body, making that drug useless in the future.

Third, in other cases, people who are faced with beginning a drug treatment that must be permanently maintained, such as some HIV medications, make the choice to delay starting the treatment until they are sure they will be able to afford to continue it. This means that they are much sicker when they eventually start treatment and that it is less likely to work for them. Their lives are effectively shortened because they cannot afford the high price of medication.

A second important theme is that cuts to health care, which can be traced directly to the Canada health and social transfer, are increasing people's out-of-pocket expenses for drugs. Because your committee is not travelling outside of Ottawa, you may not hear about the effects the CHST is having on individual people's lives. We are bringing you the voices of people in Ottawa-Carleton, yet we know that similar cuts are happening across Ontario, and we understand that other provinces are also being affected.

These cuts are of particular concern in this region, because we already had the lowest rate of patient days in the province, even before the most recent hospital bed cuts. Furthermore, it is difficult to assess the additional impact that will result from the province's proposal, as part of its so-called megaweek announcements, that the Ontario drug benefit will be downloaded to the municipalities and that the cost will be split 50-50 between the provincial and municipal governments.

People are waiting longer to get into chronic care facilities and while on the waiting list, some must pay for their drugs themselves. As of January of this year, 25% of those on the waiting list in Ottawa-Carleton have no drug plan. Once they are admitted to such an institution, the drug costs are covered by medicare. While they wait, they have to pay for their own drugs.

Hospitals are sending patients home sooner, either through the use of day surgery or early discharge. While in some cases this is due to medical advances, provincial health care cuts are also to blame. Medicare covers only the cost of drugs provided by the hospital to in-patients. Thus, the shorter the hospital stay, the higher the ultimate cost to the person. In some cases an inability to pay for post-operative medication has led to serious consequences, such as the readmission to the hospital of patients who are sicker than when they began.

Another recurrent theme is the lack of access to a drug benefit plan for working people in the middle and lower strata of Canadian society. According to the material prepared by the Department of Industry and the Department of Health for this review process, 12% of the population have no drug plan. However, other sources have indicated to us that this figure is in fact much higher.

In addition, people with high incomes can afford private drug plans, and those at the bottom have access to provincial pharmacare. However, people working part-time for smaller employers or in ``Mcjobs'' normally do not have access to any drug plan. Your backgrounder states that just under 7% of Canadians fall into this group, meaning that at least two million working Canadians must pay the high cost of drugs on their own.

All Canadians should have access to a health care system that provides the care you need when you need it. Accessibility must not be restricted by the ability to pay. Medically necessary therapies, such as prescription drugs, form an integral part of a comprehensive health care system. Therefore, high drug prices offend the five principles of medicare. The National Forum on Health recently recommended that pharmacare be included in the medicare program and that the cuts in funding to the provinces under the CHST must be re-examined.

Industry Minister John Manley in his opening remarks stated that one objective of Canada's drug policy is ``to ensure patented drugs are available at non-excessive prices''. Drug prices that are so high as to make medications inaccessible and unavailable to thousands of low- and middle-income Canadians are excessive, and as a minimum should be capped at current levels until a national pharmacare program can be developed.

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Thank you.

The Chairman: Thank you very much for a very clear presentation, Ms Arbour.

I'm going to turn now to Donald Baird, who is here from the Community Coalition on Health Care.

Welcome, sir.

Mr. Donald Baird (Chairman, Community Coalition on Health Care): Thank you. Debbie Ferguson prepared our brief. With your agreement, she will take part in the presentation.

The Chairman: Yes, absolutely.

Welcome, Ms Ferguson.

Ms Debbie Ferguson (Member, Community Coalition on Health Care): Thank you.

The Community Coalition on Health Care is a committee of individuals and organizations, users and providers of the health and social services in and for the Notre-Dame-de-Grâce, or NDG, community. Organizations represented in the coalition work with a diverse cross-section of the NDG community, including the elderly, youth and the poor. The mandate of this coalition is to assess the present and emerging health care needs of the community and to make recommendations to governments and health care providers.

As a body committed to assessing health care policies and making recommendations to government based on the needs of the residents of NDG, the Community Coalition on Health Care is compelled to voice our strong objection to Bill C-91. As we will discuss in further detail in a few moments, Bill C-91 failed to focus on what should be the primary focus of any medication regulations forwarded by the Canadian government. That focus is accessibility to Canadians.

Mr. Baird: Through the enactment of Bill C-91, the federal government promises: support for development of the pharmaceutical industry in Canada; to ensure that patented drugs are available at non-excessive prices; and to ensure conformity with Canada's international obligations. Our comments on those subjects follow.

Bill C-22 obligated pharmaceutical companies to devote at least 10% of sales to research and development. We believe Bill C-91 contains no explicit research and development demands.

The government claims that patent protection is one way to attract research and development; however, a study conducted by the Canadian pharmaceutical industry states that the Canadian tax system offers the most generous tax treatment of research and development in the industrialized world. We believe this is a very adequate incentive to the pharmaceutical industry.

Concerning the availability of drugs at non-excessive prices, we are speaking here from our perspective in Quebec, where the provincial government has taken steps to provide universal access to medication. Unfortunately, many low-income individuals cannot afford the minimum expenditures required before they are able to access free medication. These high costs are attributable to a $25 deductible and a co-insurance amount that is 25% of the cost of medication. This can result in an amount of $187 per quarter of the year. All of these are amounts that people on welfare or retired senior citizens would not have had to pay previously.

On the subject of conformity with Canada's international obligations, we understand that other countries do impose a twenty-year patent protection period. However, the federal government has been a strong world leader and a voice of reason in international trade negotiations. The Community Coalition on Health Care recognizes that if the political will exists, the interests of Canadians can be reflected through negotiations in the international trade area.

Ms Ferguson: We also have a few recommendations.

The government states that Bill C-91 will: encourage support for development of the pharmaceutical industry in Canada; ensure that patented drugs are available at non-excessive prices; and ensure conformity with Canada's international obligations. We believe the government's priorities should be to remove all financial barriers to drugs, guaranteeing that medication is accessible to all Canadians, and to ensure that pharmaceutical companies continue to develop the industry in Canada by making job creation and the financing of ground-breaking research and development integral to any regulation of competition - all of which was explicit in Bill C-22, as Don stated before. We believe the government's priority should also be to lobby international bodies to conform with policies that are in the best interests of Canadians, rather than just complying.

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We also think current health care trends that focus on prevention should be continued.

We believe government drug plans should include the funding of alternative treatment such as homeopathic remedies, which have proven to be very effective in controlling or preventing certain elements.

We agree with the National Health Forum that medication should not only be provided to patients who are in a hospital or who are in other institutions. Funding for medication should extend beyond that. It should include all Canadians.

We agree with the writers of the alternative federal budget that the government should establish a national health care fund that should include a national drug plan.

In exchange for their monopoly, multinational pharmaceutical companies should be obligated to contribute to a fund that would ensure the accessibility of drugs for all Canadians.

While Bill C-91 would enlarge the mandate of the PMPRB, the Patent Medicine Prices Review Board, we feel that a community-driven body consisting of governments, pharmaceutical companies, community workers and citizens, similar to the CRTC, should be created and should monitor and control the costs of marketing, the use of medication, etc. We believe this body should represent the public's interests. It should have the power to impose penalties and restrictions on companies that do not conform with set prices and standards.

We also believe the prices of medications should be based on the real costs of research, development and production.

Finally, we recommend that the pricing of medications be open to the public. Doctors and their patients should be able to choose the best medication not only by evaluating the effectiveness of each branch but also by comparing the prices of each.

A system of reference-based pricing was introduced in British Columbia in 1995 and is reported to have saved the government $21 million in the first ten months of its existence. We believe a similar national policy should be adopted.

The Chairman: Thank you very much. There are a lot of good ideas there for the committee.

I now turn to

[Translation]

Mr. Claude St-Georges of the Coalition Solidarité-Santé de Montréal. Welcome.

Mr. Claude St-Georges (Coalition Solidarité-Santé (Montréal)): The Coalition Solidarité-Santé has been in existence since 1991. This is a broad coalition bringing together consumer and seniors groups, community and union organizations.

We focus on advocacy and on the promotion of a universal, accessible, high calibre and free public health system. We also appeared before the Senate committee when Bill C-91 was under review. At that time, we were against extending the duration of pharmaceutical patents, unlike many Quebec organizations that had supported Bill C-91.

Your committee's review of the Patent Act comes at a crucial time in our health system's history. Ten years ago, most of our citizens readily approved, according to the polls, the idea that we probably had the best system in the world. Today, these same polls reveal that people have a great deal of doubt about the quality of our service and of its future.

We can draw some parallels between Quebec and the other provinces. Over the past few years, we have experienced dramatic cutbacks in our health system. In Quebec, more than $1 billion have been cut in two years. In the health system as a whole, we will probably see a reduction of 8%, which will result in a loss of 13 000 full-time jobs. If you factor in people working on a part-time basis, perhaps anywhere from 20 000 to 25 000 individuals will no longer have a job working in Quebec's health system.

In Quebec, two major occurrences have resulted in the gradual dismantling of our health system. First of all, there was the cutback in federal transfer payments. In 1986, federal transfer payments were used to found 42% of Quebec's health system. Today, this is been reduced to 30%. This decrease is reflected in the cutbacks that we have experienced over the past two years.

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Moreover, and now I'm getting to the topic that your committee is reviewing, the increased costs of drugs is putting considerable pressure on Quebec's health system and I'm convinced that this is also happening in the other provinces.

To give you an illustration, over the past two years, in Quebec, $80 million has been taken out the budgets of the hospitals, the local community service centres, the community health centres and the centres for the disabled.

Over these same two years, payments to doctors have increased by $77 million and payments for drugs in the system have increased by $100 million. Consequently, we can see that there has been a gradual shift in health expenditures to pay for the salaries of doctors and the increased costs of drugs. This has resulted in fewer services. Since we have limited budgets, what is spent on drugs can no longer be spent on nursing care, home care, care for the disabled or the mentally ill.

Generally speaking, our coalition supports the view given by the Canadian Health Coalition, with whom we have an excellent relationship. We're also very interested in the conclusions of the National Health Forum report.

Today several witnesses have talked about our new Quebec insurance system, which is accessible to everyone, but which entails some big expenses to be borne by the users, particularly welfare recipients and seniors. The National Forum proposed that the provinces adopt a single payer system, without user's fees. This would be the most economic and best way to make indispensable drugs accessible. In conclusion, we support the proposal to include drugs in an universal system.

I think that we have to make some choices as far as protection and research are concerned. Should we protect an industry that employs 5200 people in the Montreal region, when, in the same region 90,000 people work in the health sector? Probably 10,000 jobs will be lost in the health system in Montreal. In order to save a few hundred jobs in the industry, which is far from being certain, we agree to sacrifice thousands of jobs in the health care sector.

For all of these reasons, we agree with the main proposals made by the National Health Forum to create a national research fund.

To conclude, I would like to provide you with an opinion given by Mr. Pierre Biron, a pharmacology expert from the University of Montreal who said that true basic research, impartial research aimed at acquiring new knowledge and driven by the freedom to think and to ask real questions was on the decline.

Consequently, under the current circumstances basic research is on the decline, especially now that governments are withdrawing support.

On the other hand, we see an increase in research that is contracted out, which is well done, but targeted, private and secret. This causes all kinds of problems in terms of ethics, student training, and the possibility of pressure when it is time to publish results. What will happen to academic spirit and freedom when more than half of the researchers will be funded solely by sponsors interested only in the results of their research?

We would like to add our voice to those supporting the idea of a national fund. As for all of the positions taken by the National Health Forum and the Canadian Health Coalition, we support them bearing in mind our deep respect for provincial jurisdictions. We think that it would be possible to adopt the standards and principles of the national plan while at the same time respecting the jurisdictions as they exist in the health system.

The Chairman: Thank you very much. Your presentation is very important to us.

[English]

Dr. Brill-Edwards from the Alliance for Public Accountability is next.

I believe you are a member of the advisory board.

Dr. Michele Brill-Edwards (Member, Advisory Board, Alliance for Public Accountability): That's correct.

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I'm a physician, a specialist in drug development, and an expert in drug regulatory law in Canada. I'm speaking today for the Alliance for Public Accountability, a newly formed public interest non-profit group promoting and working toward high standards of accountability in decisions that affect the public in important ways.

We're here today to alert the committee to the impact of patent law on drug safety and to recommend three changes, three undertakings that the committee may wish to take to restore some of the imbalance that we feel is created by the patent legislation.

How does patent law impact on drug safety? The rush to profit surrounding a 20-year exclusive product monopoly creates powerful commercial and political forces that significantly interfere with the honest, complete assessment of the safety of pharmaceutical products, assessment that is required under Canadian law for the protection of Canadian citizens in the use of those products.

To put it very simply, the profit motive is often at odds with the safety imperative, especially in the short and medium term.

This high-stakes, multimillion-dollar incentive engenders a constant demand from the pharmaceutical industry collectively to rush the process of drug evaluation both before a drug reaches the marketplace and once the drug is on the market to reduce the intervention of regulatory agencies to act on new health hazards.

More ominously - more ominously - multimillion-dollar profits also at times produce almost unstoppable incentives - I would say unstoppable - for particular firms at particular times to seek to wrongfully influence regulators and their political bosses to take safety shortcuts, to downplay the risks of their products, in order to facilitate reaching a market early and reaching a market in a broad, wide way.

These are serious statements I'm making. I make them and am prepared to bear witness to them.

Is this the way it should be in Canada? No. Patent rights are not the only rights set out by Canadian law in terms of drug marketing. There are important other rights - citizens' rights to safety. Those are the rights of citizens to know that when a drug reaches the market in Canada, that drug is there without an intention and without a possibility that the citizen will be harmed by the use of that drug if harm is preventable. Their further right is that the doctor who is prescribing the drug to the citizen will act on the basis of a full knowledge set, particular with regard to safety of the product.

This balancing of rights, the patent rights and the safety rights, is jeopardized by patent legislation that places an emphasis on the prize of profit. But in truth, the law requires that citizens' rights for safety take precedence.

The Patent Act itself is very clear that no benefit can issue from a patent right until the drug is on the market, and the drug cannot reach the market until the Food and Drugs Act requirements for safety, amongst other things, are satisfied. The drug cannot stay on the market unless continuing information about safety is evaluated and disclosed fairly.

The question then arises, if this is the law, if safety rights do take precedence in law over patent rights and profit rights, then why is there a problem?

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The problem arises because, in practice, after two decades of deregulation, our regulatory systems for the validation of drug information have lost their capacity to adequately safeguard the interests of Canadians and to determine the validity of safety information.

The questions then arises: can the medical community we heard about earlier this morning be relied upon to fill in the gap? If the regulators have been demoralized, deprofessionalized, and are now about to be deinstitutionalized, can another community, the medical research community, fill in the breach? The short answer is no. As we heard this morning, the medical community is as beholden to these profit motives and incentives as are the regulators and their political bosses.

We have set forward two examples in the brief - there are many more - of instances in which particular products have been mishandled by the current drug approval process, the health hazard benefit process, run by Health Canada's Health Protection Branch.

The Chairman: We have that as part of our record. We're comfortable with that. I wonder if you could move to your recommendations. We really want you to put that on the table so we all understand where you want us to take the debate.

Dr. Brill-Edwards: Exactly. Let me simply say that the two examples refer to situations in which Canada is allowing the marketing of drugs that are costing millions of dollars and yet have health and safety hazards that are inadequately characterized.

We recommend that this committee restore the balance between patent rights and profit motivation in the pharmaceutical industry and citizens' safety rights. We recommend three actions for this committee to take.

The first thing is to initiate an investigation of the Health Protection Branch's current, continued and unlawful disregard for the safety rights of Canadians as set out in the Food and Drugs Act. This is exemplified by examples in the brief. The Minister of Health agreed publicly in October 1996 that such an investigation should be carried out. In fact, he had agreed earlier in the House that such an investigation should be carried out. His answer on one of the scandals has misled the House. I'm prepared to speak about that.

We're asking the committee to restore the balance by investigating the current situation of inadequate drug safety review.

Second, a mechanism should be initiated that will permit an ongoing review of the weakened regulator, which should be acting in the public interest, but it is not doing so.

Third, this committee should recommend that steps be taken to do away with the secrecy and confidentiality surrounding key medical information for new drugs. This is a problem that entraps the entire process. If the secrecy issue is not properly dealt with, none of the other recommendations can really be of merit.

Thank you very much.

The Chairman: Thank you very much for putting those three recommendations in front of the committee.

Our last witness is Maude Barlow from the Council of Canadians.

Welcome, Maude.

Ms Maude Barlow (Volunteer National Chairperson, Council of Canadians): Thank you very much. I'm here with Peter Bleyer, our executive director, and Brent Thompson, who prepared our brief.

The Council of Canadians is an independent, non-partisan, non-profit, national organization. We now have more than 75,000 members. I'm here today to speak about the concerns of our members about what Bill C-91 has done, and continues to do, to health care and drug prices of this country.

We believe this legislation, which was forced on us by our free trade commitments, would drain money from the pockets of Canadians and their public health care system while inflating the profits of transnational drug companies.

Our original concerns five years ago have borne fruit. I think it's important to go back and remember how this debate took place. During the debate surrounding the introduction of Bill C-91, the government regularly reminded Canadians that this measure was required for Canada to meet its obligations under NAFTA, and eventually under the World Trade Organization.

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In fact, the enshrinement of intellectual property rights under these trade deals was the result of the influence of the powerful pharmaceutical lobby. In the U.S., the pharmaceutical lobby recognized the enormous financial gain that would result from enshrining patent rights in international trade agreements. The pharmaceutical industry joined forces with the computer and information industries to create the Intellectual Property Committee. This lobby brought substantial influence to bear on the position of U.S. trade negotiators.

In Canada, the Pharmaceutical Manufacturers Association of Canada lobbied the Canadian government for these same patent protections. The result was the inclusion of intellectual property provisions under NAFTA and GATT, and the enactment of Bill C-91 in Canada.

We essentially believe this comes down to a fundamental issue of democracy. The transnational drug companies in the past, under the former government, dictated the drug policy of Canada, and to this moment they still do. We feel today that we need to have a very frank and open discussion about who's setting the rules.

The introduction of Bill C-91 was met with a considerable public outcry about its potential impact on drug prices. The Liberal Party at that time joined with groups of seniors, women's groups, anti-poverty organizations, students and churches in condemning this bill.

They along with many other Canadians recognized that this bill could cause drug prices to skyrocket, inflating the profits of transnational drug companies while taking money away from ordinary Canadians and our health care system.

I quote the Honourable Lloyd Axworthy from March 31, 1993, in the House:

We are here before you today very concerned about remarks that have been made by some senior members of the Liberal cabinet, particularly the health minister, and the industry minister, whereby it seems that this is a done deal and we have no choice. That's because having signed the North American Free Trade Agreement and GATT and having joined the World Trade Organization, Canada now is in fact obliged. We feel that this is a double negative for Canadians.

In fact, the Liberal government, which was outspoken on the impact of free trade when in opposition, is now working to expand NAFTA to include Chile and the countries of Central America and South America, push multilateral investment agreements within the OECD and the World Trade Organization, and press for trade liberalization measures with APEC, which we're hosting this year.

In my opinion, Canada is promoting the most dangerous piece of world legislation that has ever been created, the Multilateral Agreement on Investment, which will outlaw any of our abilities to undo what we're sitting here talking about today. That comes up for the OECD in May.

We're not going to go into the promises made and the jobs lost, or the promises made that jobs would be created, which we believe has been substantially proven to be untrue. We've got this here, and we've worked with other organizations.

We would like to recommend that you basically back the Canadian Health Coalition, of which we're a member, with their five-point plan, repeated in our brief.

Here are the two first thoughts. First, establish - many groups around this table have said this - a national, universal drug insurance plan. Second, ensure that generics reach the market quickly by allowing for compulsory licensing after four years of exclusive patent protection.

But in addition to this recommendation, the Council of Canadians wants to urge Canadians and the Canadian government to look again at our very strong promotion of these free trade agreements that outlaw the ability of governments to act on behalf of their citizens.

Governments in this country are no longer acting as agents of citizens but of transnational corporations. In the not-too-distant future we're going to be moving toward this in the next round of talks in the OECD, NAFTA, the Multilateral Agreement on Investment and the World Trade Organization.

I think we need to understand that it's incompatible to try to maintain control over Canadian industry when we are signing agreements that say ``Under no circumstances will you be allowed to...''. In fact, the Multilateral Agreement on Investment will give transnational pharmaceutical companies the right to sue our government if it moves to interfere with their corporate rights to free and unfettered investment.

I think we need to understand that while there may be a concern among the members of this committee, more powerful forces seem to be at work. The government of the day seems to be not prepared to move against these powerful interests, so we're here to raise a very strong concern on behalf of our 75,000 members.

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Thank you.

The Chairman: Thank you very much.

Now we come to the interesting part, where we go back over some of your ideas and allow the members to clarify thoughts, to ask questions, and to make sure they understand what you're thinking. They'll give you some idea of what they're thinking, too.

[Translation]

Mr. Brien.

Mr. Pierre Brien: I would like to thank all of you for participating in our work.

Your presentation focuses primarily on guaranteeing access to drugs, particularly for the neediest members of our society. I think that everyone can agree with this. Obviously, people may disagree on the way to do this.

Several times I have heard it said that we must have as much basic research as possible and inexpensive but high quality drugs. The employment situation must also be taken into account. You are also unanimous in saying that we must reduce the current duration of patents.

Before going any further, I would like to clarify one thing with you. You talk primarily about the situation in Quebec and about the impact that Bill C-91 has had on health costs. Towards the end, you made a reference or a comparison which one could almost describe as demagogic. I'm sure that this was not you intent and this is why I want to give you an opportunity to clarify what you said.

You said that maintaining C-91 would have the effect of protecting a few hundred jobs at most but would cause almost 10,000 jobs to be lost elsewhere. Earlier in your presentation, you had said that the $1 billion cut from the Quebec health budget resulted from a decrease in transfer payments and the $100 million increase in drug costs. How can the cost of drugs, which represents about 10% of the total cutback, be solely responsible for all of these job losses?

Mr. St-Georges: I have clearly indicated at the beginning of my presentation that the situation in Quebec was caused primarily by the reduction in federal transfer payments and Quebec's fight against the deficit. We do not agree with the choices made by the government of Quebec.

Nevertheless, the increase in drug cost is a very important factor. I am talking about $100 million over a two-year period, but in seven or eight-year time, perhaps we will be talking about $200 or $300 million in additional expenses for drugs, whose cost curve is much more inflationist than other health expenses. For instance, we could easily say that $100 million represents 1,500 jobs in the network. Obviously, I am not making a direct relationship here, but in a constant budget, if we were to constantly increase the drug bill this will necessarily have an impact on the other components of the system. Everyone acknowledges this.

Mr. Pierre Brien: Let's be more specific, because I want to try to isolate the impact of Bill C-91 in all of this.

We have talked about the increased cost of drugs in the health budget. I would also like you to talk to me about the various factors involved, because in my opinion, there may be several different factors that we have to take into account. We could talk about the impact of new patented drugs which enjoy a market monopoly and which are priced, as a result, high. We may also talk about the consumption habits of citizens. There is also the aging population. In addition, we must consider not only the patented drugs but also all non-patented drugs. Perhaps this factor should be taken into consideration as well in explaining the increased costs. Consequently, as far as I'm concerned, there are several variables and Bill C-91 is but one of them.

Mr. St-Georges: I'm in perfect agreement with what you have said, and this is why we are supporting the National Forum when it says that we need a comprehensive drug policy that takes into account the cost of purchasing drugs as well as a whole host of marketing factors such as bulk buying and state management of the system, by the provinces, rather than have a fragmented system. A single payer system would have a positive effect on bringing down the cost and on any issue pertaining to the conduct of doctors who give out prescriptions.

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Quebec's seniors receive 30 prescriptions per year, and everyone knows that this is too much. The number of prescriptions is escalating from year to year. Of course, C-91 did not create this situation, but we have to take a look at this whole issue of drugs and determine on how to reduce costs. Patents is but one aspect but it is a very important one.

Mr. Pierre Brien: Earlier, a witness representing the Montreal Urban Community, who's also a doctor, was saying that there has been a lot of medical discoveries, drugs that enable us to avoid surgery today.

Consequently, as costly as these new drugs may be, they are often less costly than hospitalization or surgery. The new drugs, which appear to be very costly to us, most be viewed as alternatives to the medical treatments that existed previously. Therefore, these drugs may lower the costs of the health system.

Mr. St-Georges: I am no expert in these issues, but there have also been developments in other medical science fields. For instance, we now have new surgical procedures, whether they be in orthopaedics or in some other field. Technological advances are not exclusive to drugs. When drugs occupy a growing portion of the budget, it reduces access to other technologies and to home care, because too much money is being spent in order to reimburse the cost of drugs.

Mr. Pierre Brien: I would ask Mr. Alper a question, because I can tell that he wanted to answer some of the questions that I had asked.

You mentioned the impact that Quebec's drug insurance plan has had on certain client groups, but one client has benefited greatly from this. One million or 1.1 million people were not insurable in the past. I am speaking specifically about low income part-time workers who now have access to this plan. This is a considerable improvement for these people. I know that this has had some consequences for the two client groups who previously did not have to pay what they are paying now: namely, people who live on welfare and seniors.

Your concern is to serve these clients. A few years ago, I lived in Côte-des-Neiges, when I lived in Montreal. I'm very familiar with this reality. Could we not try to achieve your objective in some other way rather than reduce the duration of the patents? Is there no other way that we could come up with some solutions for the clients that you are defending? We could have an overall solution for the problems, which would not necessarily be aimed at reducing the duration of the patents.

Mr. Alper: I am no patent expert, but what is clear, is that the cost of drugs is too high. Why? We believe that it is because of C-91. We agree that the introduction of Quebec's drug insurance plan is a step in the right direction for some people, but only a small minority of the population benefits from this legislation because of the high premiums, the deductibles and the co-insurance.

You refer to hospitalization savings. One of my colleagues invited me to sit on a committee that was set up by the Quebec Ministry of Health to examine the problem of mental health. We acknowledge that hospitalizations have escalated dramatically because of drug insurance. This committee wanted to identify one or two drugs that could perhaps be given at no charge to people with serious mental health conditions in order to avoid hospitalization costs.

We know that the Quebec Government has already changed its regulations so that people can have free access to drugs to treat tuberculosis, but what about people who are stricken with other serious or terminal diseases, such as AIDS, cancer, cystic fibrosis, to name but a few?

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Our objective is to ensure that all citizens have access to drugs. In our opinion, it is clear that Bill C-91 constitutes an obstacle and that we must find some way to ensure that citizens have this access.

I would like to turn the floor over to one of my colleagues, a woman who lives in the neighbourhood experiencing these problems.

[English]

Ms Ruth Friedman (Member, Project Genesis): I am a senior citizen, and I take medication because I have a heart problem and asthma. I get many medications, and my doctor assures me that I should not miss any. But sometimes I have no choice, because I'm on a pension and it's a meagre one. I worked all my life to be able to live in peace. Out of the pension I have to pay my rent and for food and clothing, such as a pair of shoes. I don't know which one should be the priority, the medication, the food, the clothing, shoes for the winter or what.

Last month I didn't take all my medication. The other day I went into the pharmacy and I said I would take what was missing, so he gave it to me. He said, it's $24, but you have to have the rest of it. I said, I haven't got the money. The pharmacist said, I'll trust you. I'll give you all the medication because you must take it; otherwise, you'll have heart failure. So he gave it to me and said, you should come in next week. I said, I'll come in when I get my pension cheque.

Is that a way to live? I go into the pharmacy and I can't afford to buy my medication. The pharmacist knows me because he has been my pharmacist for the 11 years I've lived in that neighbourhood. Not being able to pay him and not having a few dollars to buy some food to take home makes you get sicker and more depressed than not taking the medication altogether. You want to have the choice to take the medication or not to take the medication.

This is what we are left with. This is the alternative the government gave us. You're charging us for the medication. Why attack the weak, the elderly and the poor? I'm not poor. I worked all my life, and I get a pension from the federal government and the Quebec government. But if I have to spend half of my pension on medication, how much would remain for my rent, my food, my clothing, transportation and what have you? I would like to have advice from you people as to how I should live.

The Chairman: Thank you. That is a good reminder for everybody.

Ms Friedman: Thank you.

The Chairman: Mr. Brien, is that okay for now?

[Translation]

Mr. Pierre Brien: I will come back to this later on.

[English]

The Chairman: Dr. Hill, please.

Mr. Grant Hill: Dr. Edwards, you made a strong statement that the health minister had misled the Canadian people. Could you expand on that for me, please?

Dr. Brill-Edwards: Yes. I'm speaking specifically of the case of the calcium channel blockers, which are heart drugs used in the treatment of chest pain called angina, and high blood pressure. This is a well-publicized controversy and scandal. It came to public attention in 1996 through an investigative media report.

The minister was challenged in the House, actually by you. His response to you on that matter was that he would investigate. He indicated at that time that he felt the allegations that the drug nifedipine, and the class of drugs, calcium channel blockers, had been mishandled, was false.

In response, an investigation was carried out within the branch, which records show was inadequate but did reveal that there was a conflict of interest seriously compromising the decision of the Department of Health. The minister did not come back into the House. He had his deputy write a letter to you as a member of the opposition and also to citizens who had made similar inquiries.

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That letter stated very clearly, for the record, that at the time the drug was marketed in the early 1980s, there was long-term safety of adequate nature to justify marketing. This is contrary to the allegation. The record in the confidential files of the Health Protection Branch shows that the very statement quoted in the letter sent to opposition members and to citizens comes from an evaluation of the drug that states that there was substantial safety data. The minister's letter stops there.

The truth of the matter is that the file goes on to say that it is these latter data that gives cause for concern. It then goes on to describe in detail serious concerns about the drug that were evident to the regulators back in the 1980s, concerns that over the following decade and a half were allowed to go unanswered despite more and more evidence accruing that these safety problems were real.

I think that is totally unacceptable. In my judgment as a citizen, it is not acceptable that a minister can write half-truths to citizens and to members of the opposition and can do so with the certainty he will not be challenged because the files are confidential, and if anyone who knows about those files speaks, they will lose their post, they will be dismissed for cause, and no one on the outside has access to the files.

Mr. Grant Hill: How did you get hold of the file?

Dr. Brill-Edwards: At the time the scandal was beginning to erupt in 1995, I was a member of the Health Protection Branch's bureau for human prescription drugs. The issue bothered me sufficiently that I went back to the old files to see what was the nature of our decision at the time we put this class of dangerous drugs to market. When I found the evidence that was there, I brought it to the attention of my colleagues. There was a very clear imperative not to address that issue.

I eventually brought that information to the attention of the Assistant Deputy Minister and the Deputy Minister on the occasion of my resignation from the department, when I could no longer live with what was going on. I reached that point after multiple episodes of drugs being mishandled, which could have been and should have been dealt with according to the law in the public interest.

Mr. Grant Hill: You're talking about a serious allegation here, about HPD doing things that are not in the Canadian good. How can we fix that? It is an advantage to the companies to have the approval done as quickly as possible. Would it be better to have the patent protection time from the date of approval rather than from the date of application?

Dr. Brill-Edwards: That would certainly alter some of the incentive to shorten the review process. Unfortunately, patent law is very much influenced by international circumstances, so I can't comment on whether or not a proposal like that would fly, if you will, in a global pharmaceutical community.

But what we can do is at least contemplate the matter. We can at least propose it. We can at least acknowledge that the circumstance under which a 20-year patent that only begins to pay off when the drug actually comes to market - that is, after many years of the patent life have already been used up with drug evaluation - is distorting the safe and deliberate review of the drugs.

Mr. Grant Hill: Thank you.

I'd now like to turn to Dr. Khatter. You mentioned Beclomethazone, the puffer that has been the old standard and that is relatively inexpensive. The new medication you would like to prescribe for everybody is very expensive. I'd like to know how you figure that new preparation would come on stream if there was no incentive for research in that regard. I have difficulty seeing how innovation would happen.

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Mr. Khatter: Certainly you have the lung foundations, you have the asthma foundations, you have non-profit groups that represent clientele and that the government could put money into, that pharmaceutical companies could also put money into if they wanted to sponsor research, and who are interested, as well as the clients and the consumers - the patients themselves - in seeing newer and better drugs to treat or cure asthma.

Having worked in a research laboratory at times in a university setting, researchers themselves are self-motivated to produce the best thing possible to work for the public good without necessarily the need for a profit motivation.

Mr. Grant Hill: Would it drive all the research completely away from private enterprise?

Mr. Khatter: I believe this was mentioned in the last group as well, that there is a conflict of interest in terms of pharmaceutical companies directly funding researchers.

We have evidence from Industry Canada surveys that of researchers in Canada, 90% of them said, yes, there's a potential conflict of interest; 80% of them said, yes, these are me-too drugs we're doing; and 40% said that if we don't come up with results that are perhaps favourable, there will be a delay in publication.

That conflict of interest exists in that we need an independent body in between to make sure: that the research that's done is the research that needs to be done; that the results are quality and true; and that we have funding of alternatives to drug therapy.

If we move towards pharmaceutical companies doing all the funding for research in health care in terms of treatments, we're going to get newer and more expensive drugs that people need to take for a long time rather than who's going to pay for the research to show why we don't need those drugs or how we can do things more cost effectively.

Mr. Grant Hill: One of the criticisms we've heard regularly is that physicians are getting their information from the wrong source. We have access to peer-review journals regularly. Do we get our information on the prescribing of new preparations from the wrong source, in your view?

Mr. Khatter: We definitely get our information from the wrong source. It was actually the topic of my resident thesis when I was training. As much as there are peer-review journals out there, physicians don't have a lot of time and energy to sift through all the peer-review journals and all the new information.

What is easily accessible to us is the drug rep who comes and knocks at your door, who has information for you, which - of course, you can see it as objective, and it never includes the price, by the way - comes from someone who has a bias, an inherent bias.

So I think the two major sources are the drug reps as well as conferences that generally are supported by drug companies that have a lot of tables and a lot of advertising on them. Studies have shown that sales do increase after those conferences. There are studies that show an association, anyway, between physicians who tend to use drug-company advertising the most and irrational prescribing.

Wendy Muckle, who's with me from Sandy Hill, can perhaps add something.

Ms Wendy Muckle (Director, Health Services, Sandy Hill Community Health Centre): When I first went to the health centre, we had a policy in place that we did not allow drug reps to come into the centre. That was because we wanted the physicians to get their information from the right place, and we thought that was a good way to do things.

As the price of drugs went up, more and more of our clientele could no longer afford drugs. We rely increasingly on drug companies to supply us with samples. Otherwise, our patients can't get what they need. We've had to completely change our policy.

We have two huge cupboards in our centre where we keep drugs on hand for people who can't get them any other way. We just spent $10,000 buying drugs for average Canadians who can't afford the things they need. The alternatives are inhumane, and they're most costly. It just makes common sense to do those things.

I quite agree with Kapil that we are getting our stuff from the wrong source, and we know it. But I don't think we have any choice in the situation we're in right now.

Mr. Grant Hill: Thank you.

The Chairman: Mr. Murray.

Mr. Ian Murray: Thank you, Mr. Chairman.

I think we've lost our witnesses from the Council for Canadians. Maybe I'll ask Mr. Alper a question, then.

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To begin with, we've had this ongoing discussion about increased cost versus increased prices, and you were attributing increased cost to Bill C-91 in your comments. We've had evidence from the PMPRB that the brand name drug prices, since Bill C-91, have either gone up very little or in some years actually declined in price, while generic drugs have increased at 3.2% a year.

First of all, do you have faith in the PMPRB? That's really what I'm trying to get at. Do you believe their figures? If you don't, do you have an alternative source that you're using for that information?

Mr. Alper: Once again, I work as a community organizer in a neighbourhood organization. I don't have any medical training. I'm not an expert on these issues. Certainly what we see, though, and what people are telling us day after day, is that they simply cannot afford their medication; the price of their medication is continually rising. Over the last few years the figures we know to be true...in Quebec, the cost of drugs as part of the total health care budget has risen 23% from 1990 to 1995, while spending on hospitals and community health clinics has only risen 3.4%.

We know as well that Quebec is the province that has the least amount of generic drugs prescribed, and a large part of medication covered by the Quebec Health Insurance Board is patented drugs. When you have in place legislation like Bill C-91, which allows a 20-year protection on patented drugs, and where the market forces aren't in play, don't seem to have any influence on what the price of the drugs are, it seems quite clear to us that the companies are basically charging what they think the market will bear. To us, it seems there are absolutely no price controls in terms of patented drugs.

Mr. Ian Murray: Perhaps I could address myself to Mrs. Friedman. All of us have tremendous sympathy for the situation you find yourself in. You may not be able to answer this question, but I was wondering if you know if the drugs you are taking are brand name drugs.

Ms Friedman: Yes.

Mr. Ian Murray: Okay, thank you.

Dr. Brill-Edwards, in getting back to this very serious indictment you have levelled at the Health Protection Branch, you were suggesting that this is because of the rush to profit by drug companies. Does this only occur with brand name drugs or is this common in the industry, whether or not it's generic or brand name?

Dr. Brill-Edwards: I think the profit incentive is common to all sectors of the industry, whether brand name or generic. The reality of life is that the brand name firms have historically had the lion's share of the market and the influence of the generic firms has been relatively small up until now. You're quite right that a profit incentive will be a motivator, regardless of whether we're speaking of a brand name firm or a non-brand name firm.

I would point out, though, that particularly in relation to Bill C-91, many of the health hazards that are allowed to persist without the lawfully required intervention of the Health Protection Branch are allowed to persist out of consideration for patent issues.

For example, there's the issue we just discussed, nifedipine. There is a very clear linkage between the amount of time that the manufacturer has requested that we leave the drug, an unsafe drug, on the market in an attempt to prove safety...which is of course backwards. The law requires the opposite, but we're allowing this company to undertake a study to prove safety. The study will take several years. There won't be an answer until roughly 2000. Interestingly enough, by coincidence, that's just around the time when the patent will run out.

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Do you see what I'm saying? This is a very complicated area. I'm not suggesting the industry committee should make itself conversant with these kind of complexities. What I am asking is that you respect the fact that when we create 20-year patent rights, in my judgment, we create forces that we have lost the capacity to control.

Mr. Ian Murray: So the HPB has no right at some point during the life of that patent protection to say: We made a mistake; we found something new and we're going to call a halt to the distribution of this drug.

Dr. Brill-Edwards: To the contrary. We not only have the right, under law, but we also have the duty. The enabling legislation of Health Canada gives to the Minister of Health the duty to uphold the Food and Drugs Act. It's not a discretionary power, it's a duty.

Mr. Ian Murray: One would assume that, I would think.

Dr. Brill-Edwards: The minister recently tried in the rewriting of that enabling legislation to have that duty removed, and it was only because of the intervention of citizens' groups that this move was reversed. So what we're talking about here are extremely powerful forces that work behind the scenes in ways that are often unappreciated by the public and by those of us who are not in the thick of it.

Mr. Ian Murray: Thank you.

Mr. Shepherd will share my time, Mr. Chairman, unless I'm over my limit.

The Chairman: Go ahead, please.

Mr. Alex Shepherd (Durham, Lib.): Dr. Brill-Edwards, your organization is the Alliance for Public Accountability. How many members do you have? Who are you representing here today?

Dr. Brill-Edwards: We're a citizens' group. We have in the order of a hundred members. We formed just last year, in 1996. We are focusing our efforts at the moment on helping individuals and groups to understand the tools, the mechanisms, by which citizens can bring about quality answering from authorities on decisions that are important to the public, both in the private and the public sector.

Mr. Alex Shepherd: You make some very serious allegations here.

Dr. Brill-Edwards: Indeed.

Mr. Alex Shepherd: Basically what you're saying is that there's some kind of collusion between people who work with HPB and the pharmaceutical industry.

Dr. Brill-Edwards: I don't use the word ``collusion'', because, to me, it's not necessary to postulate that there is any such activity.

Mr. Alex Shepherd: You said that people rush through this process because there were very wealthy companies sitting out there wanting these things done for them. How does it work? Does somebody pay them off? Why do they rush because there's a pharmaceutical company on the other end of this? How does it happen?

Dr. Brill-Edwards: The manner in which it works is really relatively straightforward. If a company has a particular interest to be served, they communicate that interest through a variety of mechanisms to authorities, either in the political arena or in the administrative arena. Those interests are then communicated in very traditional, ordinary ways down through the bureaucracy. For example, a reviewer will simply become aware that his superiors are interested in what is happening with one particular file as opposed to the others he's dealing with.

For example, when I was in charge of the drug approval process it was not uncommon for my staff to come to me and say: Why would the DG call me about drug X? Indeed, why would the director general, who's three or four levels up, bother to be talking to a reviewer about a particular product, particularly when the director general has no medical knowledge and no understanding of the work of the reviewer?

So these things are communicated in very ordinary, businesslike ways. Pressure is brought to bear, not by any surreptitious men in black trench coats and black hats in back rooms. It is a standard business process. Senior executives in a firm are expected to spend time contemplating what issues might threaten or benefit their firm's bottom line.

Mr. Alex Shepherd: Are we bending the compliance system? Is that what you're saying?

Dr. Brill-Edwards: We're not only bending it, we're breaking it. I can point you to drugs that are on the market illegally.

The Chairman: Final question, Mr. Shepherd.

Mr. Alex Shepherd: You made a statement in your submission that large numbers of Canadians are dying needlessly. Can you substantiate that?

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Dr. Brill-Edwards: Of course I can substantiate that. Mr. Shepherd, I must advise you that in my former position with Health Canada I was, on a daily basis, disciplined to respond to questions like this in a manner that would withstand legal challenge by multimillion-dollar pharmaceutical firms. I don't make these statements lightly.

The specific statement there refers to the documented increased death rate on short-acting nifedipine as compared with alternative treatments for the same disease, the treatment of hypertension. That is an issue the Health Protection Branch refuses to deal with adequately. They have dealt with that issue by simply advising doctors that there may be a problem, and have refused to take the drug off the market.

But as you've seen, how do general practitioners know whether to use a drug or not? If the drug remains on the Canadian market, that is the minister's guarantee to Canadian physicians and their patients that he believes, through rigorous assessment of confidential safety data, that the drug belongs on the market. Yet the international drug champion for nifedipine has recently given an interview to The New York Times, saying quite clearly he believes the drug should be off the market. Now, that's not the critic of the drug, that is the former advocate - a well-recognized international expert advocating nifedipine.

[Translation]

The Chairman: Mr. Brien, do you have any questions?

Mr. Pierre Brien: We are talking about a company that would market a product knowing full well that it constituted a health risk. Once the public were to find out about this, do you not think that the company's reputation would be completely ruined and that it would find it incredibly difficult to sell its drugs? Would it not be risky for a company to conduct itself in this fashion? The day that the public were to find out that a company had done this on purpose, it would be faced with consequences that potentially could jeopardize its own survival.

[English]

Dr. Brill-Edwards: You'll notice in our brief that we refer to the short- and medium-term incentives. In the very long term - and I'm speaking of a 20- to 30-year long term - it is possible for a pharmaceutical firm that plays a high-risk safety game to lose, to be caught, and to suffer irreparable damage to their reputation. But in the short and medium term it is almost impossible for that to happen, almost entirely because the control of information is such that it is very hard for physicians out in the field to recognize that safety risks have been taken. I can give you multiple examples. It is also equally clear that it is very hard for even the courts to find out.

If you look at all the drug disasters we can point to in the last decade or two that have resulted eventually in not only loss of reputation but bankruptcy for firms, the early phase of discovery of the unnecessary and in some cases criminal risk-taking has been buried in the courts.

Usually there is a period of five to ten years where cases that go to civil litigation against the company are settled, and the files are sealed. I was involved in one such case just this summer. The moment it was realized through legal documentation by our department that I would be allowed to speak under oath about what I knew about the drug, the case was settled, the files were sealed - end of story.

So you see, in the short and medium term, it does work, and huge profits accrue to the risk-takers - no question about it.

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[Translation]

Mr. Pierre Brien: If we had a mechanism to restore patents, namely, to extend the patent to compensate for the approval period, would this not ease the pressure of the fast track process, which may have an impact on health?

Right now, the protection period is 20 years. If the statutory mechanism has resulted in a loss of two, three or four years, and the patent were restored for an equivalent period, would this not ease the pressure or reduce the negative impact that now exists?

[English]

Dr. Brill-Edwards: I think it would act to reduce the pressure on the regulatory system. As I mentioned earlier, I'm not sure how feasible it is to have Canada out of step with international patent law, but the proposal would have one failing in that it would still not address the issue of diminishing the wish to have the regulator interfere in safety hazards once a drug is on the market.

So as long as you understand, my answer is, yes, your proposal would address, to at least some extent, the need to reduce the pressure on regulators prior to approval.

[Translation]

Mr. Pierre Brien: Thank you.

[English]

The Chairman: I'd like to thank the witnesses. I think this has been the most impressive group for the specific ways you brought your recommendations in front of us. Your testimony, whether it was from the Sandy Hill group or from Montreal, was very persuasive.

I'll just leave you with one thought - and if you have any further comments and want to drop us a note, you're welcome to - that the difficult role for the committee is not so much doing any denial about the high cost of drugs but trying to find out the causality in the relationship between Bill C-91 and the observations you make at the community level.

David, your response was a genuine response, and I don't know if I can answer that. You know, we're halfway through the process, and I don't know whether any member on this side would care to answer that question right now.

But our job is to try to figure out to what extent the issue of whether the access of the $16 asthma drug is the issue - and it definitely is the access of the $90...or is it the question of whether or not the $90 drug actually exists, and how do you organize the research for it? Do you do it through public funding or through the companies themselves?

I hope you can sympathize with us. These are not easy questions to deal with and to resolve in any final way, but we want to make sure we all understand the ways in which Bill C-91 has contributed both to the health of Canadians or the opposite, if that's the case, and to the industrial development of an industry that is said to provide some benefits for the country.

You've raised questions and given us some good observations. As I say, our job is to pull together these observations and try to attribute causality. If there's anything you want to say further on, please feel free to drop us a note or contact your local member of Parliament or any member of this committee. We'd be happy to hear from you again.

Thank you, and for those who have come from Montreal, thank you very much for coming in and visiting with us. We appreciate it.

The committee is adjourned to the call of the chair.

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