Health Committee on April 15th, 2008

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

What about the Canadian Diabetes Association, though?

[Alan Cassels]

Okay, but let's take those two first. They are what we would call astroturf organizations. There's a clear strategy by the public relations companies working for the manufacturers to create patient groups to give their imprimatur of respectability to this kind of thing.

In terms of the Canadian Diabetes Association, the question I would ask is, how much money is the Canadian Diabetes Association receiving to lend their good name to this kind of advertising? I look at the guidelines produced by that organization and I ask, are these guidelines evidence-based? On some things they are very good; on others, it's as if the guidelines were written by somebody who works for a company selling those drugs.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

I would like to point out that about a year ago there was an organization that came to the committee, I think it was the Best Medicines Coalition, that maybe did not disclose as much as it should have.

I'm running out of time, so could I hear your views on the life-cycle approach to products.

[Dr. Robyn Tamblyn]

On progressive licensing?.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

No, the life cycle.

[Dr. Robyn Tamblyn]

The bottom line is that the provinces are paying both for the benefits and the consequences of not doing such a great job at evaluating things. They either do the foot-dragging approach of gee, this is pretty expensive and I don't really know, and I can't control it, and whatever else.... It's preciously important to actually get real-time information on who the drug is being used on and what the experience has been. Quite frankly, we have the capacity, if we keep it at a steady state—and, ideally, grow it a little bit—to actually answer these questions.

For example, one of the most notable studies that looked at how well a drug worked in practice in fact discovered that inhaled corticosteroids actually reduced the risk of asthma death, or near asthma death. That study was done by a group of researchers from McGill—not to be proud of my university or anything, but that group was from McGill—who used Saskatchewan data to try to address a problem that had been identified in Australia. Because we have such unique data here, we could actually answer that question.

It turns out that with one of the drugs that was producing a 55-fold death increase, a fast-acting rescue medication, the problem was essentially that it was very potent. What they discovered serendipitously through this was essentially a drug that is incredibly protective, just as we discovered that Aspirin is incredibly or wonderfully protective as time goes on.

It's these lessons learned that are going to come from ongoing pharmaco-surveillance of medications. It's expensive; we spend a lot of money on it, and increasing amounts of money on it, so we should do it right and actually monitor it, just as surgeons are monitored.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you, Dr. Tamblyn.

We'll now go to Madam Wasylycia-Leis.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Thank you very much.

I don't have much time, but I would like to come back to the Bloc's question about direct-to-consumer advertising, as I think it is a problem in terms of both costs to our drug system and problems in terms of drug safety. It's about pushing drugs onto people and accelerating demand.

I believe this present legislation will open the door wider to direct-to-consumer advertising, so I would like to know what you think about it, if you have had a chance to look at it. But if you haven't, could you comment on the fact that the minister says there is no change with respect to DTCA? In other words, the status quo will continue, and all the ads that you've shown today, Alan Cassels, will be permitted and be allowed to multiply, because they don't tie the specific condition to the name of the drug.

Can you comment on the advisability of closing that loophole in the drug regulations and what we should do about any opening of the door on this issue with respect to the broader DTCA matter?

[Alan Cassels]

I think that opening the door to DTCA is a very bad idea. You can take the experience in the U.S. with Vioxx, for example, one of the most widely prescribed drugs in the history of the world. The uptake of that drug was huge, and the impact on the population, as we've seen, was deaths in the tens of thousands.

I'm not sure whether the current legislation before the committee is really going to open the door to direct-to-consumer advertising. But if it does, they're going in the exact opposite direction they should be. What we need to be doing is enforcing the current laws that we have. There's good evidence that our laws around direct-to-consumer advertising are not being well enforced. We could actually reduce the effects of advertising from the U.S.

Someone might ask, well, what are you going to do about the Internet? I would say that one of the best things to do is to counter marketing with quality, objective drug information. That's what Canadians expect, and I think that information has to be provided by the public purse.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much, Madam Wasylycia-Leis.

I'd like to thank the witnesses for your presentations and for answering all the questions. Thank you very much. You may be excused now.

We'll continue with our meeting.

Mr. Thibault, would you like to introduce your motion?

[Robert Thibault, Liberal, West Nova, NS]

The motion has been circulated.

The principle of the motion is quite simple. And it's not prescriptive; I'm not writing the legislation in this motion. I'm asking the minister to redo the legislation in a way that doesn't target any specific group, but that looks at the risks--where you would have risk from donors because of specific lifestyle issues, not whether you're part of a same-sex group or not.

It's making sure that we protect the supply of organs. With the current regulations, people are refusing to consider potential donation because they are on the list of who should not be donors. The practitioners have the ability to use those organs, with the proper signatures and all that, but the problem is that people will not become donors with those regulations in place.

This seeks to repair that. It's a request to the minister to modify the regulations. Therefore, I would move the motion.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you.

Mr. Fletcher.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

Thank you, Mr. Chair. I have several comments about this motion.

First of all, it's wrong; it says things that are simply not true. Nowhere in the regulations, for example, does it exclude gay men from donating organs. The current regulations are based on science; they're only based on science.

I want to reiterate that contrary to what has been reported in certain media, the regulations do not ban homosexual men and others with identified risk factors from donating organs. No Canadian will be prevented from becoming an organ donor based on gender, race, age, or sexual orientation. The primary focus of these regulations is safety, with the recipients in mind.

We have moved a long way since the lessons of the tragic tainted blood scandal, and those lessons must never be forgotten. The prevention of transmission of disease to transplant recipients is the primary focus of these regulations. Sound, scientifically based risk management is at the centre of the regulatory framework, and it's consistent with international standards and best practices.

I'd like to remind you that in 1999 the Standing Committee on Health, in a report entitled “Organ and Tissue Donation and Transplantation: A Canadian Approach”, recommended that cells, tissues, and organs--CTOs--safety standards be made mandatory through incorporation into regulations under the Food and Drugs Act.

The CTO regulations came into force on December 7, 2007, following extensive consultations over 11 years with the transplant community and Canadians. That includes most of the time during the previous Liberal regime. During these consultations, not a single comment objecting to the current wording of the applicable risk factors for infectious diseases was received--not a single comment.

The technical context of these regulations is based on standards developed by working groups of independent experts appointed by Health Canada, which included representatives from the transplant community, provincial and territorial governments, transplant recipients, and the ethics community. These standards were first published in 2003, under the previous government.

These regulations enshrine into law the best practices that have been ongoing in Canada in the field of transplantation since the mid-1990s so that transplantation will remain safe for Canadian patients. The same risk criteria are used in the screening of donors in the United States, Europe, and the United Kingdom.

All risk factors in annex E are based strictly on scientific evidence. They are used in assessments that evaluate behaviour and medical circumstances and do not target specific groups. For example, gay men are not singled out, or even referenced--

[The Vice-Chair, Liberal, Lui Temelkovski]

Mr. Fletcher, are you reading your letter to us?

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

No. These are just some comments I'd like to share.

[The Vice-Chair, Liberal, Lui Temelkovski]

Where's annex E?

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

Annex E is in the regulations or the CTO material. Annex E explains who can and who cannot donate.

[The Vice-Chair, Liberal, Lui Temelkovski]

Could you wrap up, please?

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

I would be happy to.

For example, the “men who have had sex with men” category includes men who would not consider themselves homosexual.

If a donor falls into a high-risk category it is a decision between the recipient and his or her physician as to whether a transplant is appropriate. No eligible organs are wasted or discarded.

Testing alone is not adequate to eliminate risk. Testing of potential organ donors is performed at the hospital level and uses less sensitive tests than those used for blood donors.

It is important, Mr. Chair, that I get this in, so please bear with me for another minute.

It is important to note that the Canadian Standards Association is an independent, not-for-profit association that functions as a neutral third party providing a forum for committees of experts to work on standard development. It is one of four organizations accredited by the Government of Canada to develop national standards.

The CSA is responsible for more than 3,000 standards, codes, and information products in the areas of health care, the environment, and public safety. Moreover, Canada is perceived as a regulatory leader in the field of transplantation safety. The WHO has recognized Canada's leadership in this area, and recently Australia has requested permission to use our standards in the development of their regulations.

The CTO regulations are sound. They're based on science and in line with international practices and don't need to be changed. The CSA technical committee is currently reviewing the risk factors contained in the standards to assess whether new scientific data has arisen that would point to a need to adjust the risk factors.

The Minister of Health will report on the results of the review when the work is complete, in about three months' time.

This motion is not necessary. It contains false and misleading information, and the committee should focus on the work that is before it.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much.

We have a number of other speakers: Mr. Thibault and then Madame Gagnon.

[Robert Thibault, Liberal, West Nova, NS]

I'll be very brief, because I would hope this comes to a vote today. I would only say that the problem is with annex E, which has exclusionary criteria. Included in the exclusionary criteria are men having sex with men, whether or not it's safe sex, unsafe sex, whether or not it's one man having sex with multiple partners or in a monogamous, safe relationship. So that is the problem.

It is true--and we've heard that here--that transplant physicians can use organs from people who are on the exclusionary list with the proper permissions and all those things. That is fine. The problem arises that because we have these standards, based on CSA annex E, that exclude specific groups, those groups are not signing their cards to become donors. So this reduces the pool of available donors, and that is the problem.

The motion does nothing to reduce the safety. There are safety aspects, but the motion calls on the minister to draft regulations that are based on risk and not on sexual orientation.

One final poin: What we have to ensure is that our regulations will also survive. These regulations as currently stated might not survive the test of law. We saw in the work of the Library of Parliament that it was derogated powers to the second degree, where the law now gives the cabinet the potential to make regulations. Here cabinet again gives CSA the possibility of making recommendations, because it's CSA that does annex E. So cabinet is no longer making regulations, but a third-party organization.

But time is running short. I hope we are able to vote before we leave.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you.

Go ahead, Madame Gagnon.

[Christiane Gagnon, Bloc, Québec, QC]

It is true that Mr. Fletcher is partly right in referring to regulations and standards. However, we could ask for regulations not to be based on a standard. The standard is restrictive and not respectful of the population as a whole. Reference is made to men having had sexual relations five years before an organ donation. I think that is absolutely unacceptable. Why not mention high-risk behaviour?

For instance, if a woman has had sexual relations with a gay man or bisexual man who engaged in a high-risk behaviour, she may not necessarily be inconvenienced, but she would probably also be high-risk. That would be discriminating against a significant section of the population.

You have to have a moral conscience when you want to donate an organ, for instance. It would be up to individuals, men and women alike, to comply with the conditions required of organ donors. I am in favour of this amendment because this standard sends out the wrong message to society. As you have stated, there are tests that are offered. Tests are done on all organs, and they are very reliable. It was mentioned by scientists who came to see us at the last two meetings.

It is very self-righteous to introduce such an exclusive standard. We maybe voting on this soon; as far as I am concerned, my mind is made up.

[The Vice-Chair, Liberal, Lui Temelkovski]

Thank you very much.

Would you like to comment, Madam Wasylycia-Leis?

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Thank you, Mr. Chair.

If I speak just briefly, may I have your assurance that we'll still be able to have the vote before the clock runs out? Will we be able to extend the time briefly?