Health Committee on Jan. 31st, 2008

[The Chair, Conservative, Joy Smith]

Madame Gagnon, your time has run out, but I will let the witness answer your question.

Would you please be so kind as to answer madame's question?

[David Lee]

Picking up on the ICH implementation, I think we need to state very categorically and strongly that there is no intention in the modernization to decrease the amount of science that you need to get approved to make sure that there is a favourable benefit and risk for the product when it goes onto the market. That's very important to state. So there is no compromise or shortening on that at all.

The idea is that as you go from the pre-market, which is really an experimenting with the drug, there are still quite a few things you don't know when it gets out into the real population. That's where the science is really starting to grow. It is fairly new. We probably don't have enough pharmacoepidemiologists in the country.

There is a lot of hope, though, that we can work with our decision-making partners in the provinces and so on to really get the best interventions when they make sense. So you really want to keep your surveillance of those risks that are plausible risks that make sense.

And there is a lot of planning element now, so pre-market, a lot of what's in the international environment is making sure that before a drug company is allowed to sell a drug, even in the pre-market situation, they have a really good plan for how they're going to track risks out on the market. And there is a lot more commitment to that planning.

And that starts to appear in regulations. That's not about decreasing the standard for getting on; it's really about governing, and looking, and planning well. Planning doesn't get you everything, so you still need interventions if something is going wrong with a drug, but the idea of planning is fundamentally a good one, we think, and it will improve the oversight.

[The Chair, Conservative, Joy Smith]

Thank you, Mr. Lee.

Madam Wasylycia-Leis.

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

Thank you, Madam Chairperson.

And thanks to all of you for your presentation. It's very timely, actually, that we've started these hearings at the same time as, I understand, your department has started hearings on what I think would probably be considered the fourth attempt in the last decade to overhaul the Food and Drugs Act, always under the premise that it's outdated and needs to be modernized, and always based on moving our system from a precautionary model to the risk management model.

Everything you've told me today sends up all kinds of alarm bells that you're simply trying to do what we have defeated four times over at this committee or in the House for the last decade. Everything you've suggested to me today and to us says that in fact you're advancing the agenda for minimal pre-market precautions and beefing up the post-market end without necessarily ensuring that this government and this department have done their utmost to ensure that the products put on the market are safe beyond a reasonable doubt.

My first question is, why do you think the risk management model, which is to let the buyer beware and take their chances, is better than the do-no-harm principle? And how is that good for Canadians?

[David Lee]

This is a question that really does go down to the heart of the whole model. Frankly, if we were advancing a model that was lessening the standard upfront, then you would be right to be concerned, but we're not doing that. We need to be very clear here that we want to keep the science uniform upfront. There are some good advances going on in science--new modelling, new statistics--and we can take a look at those good evolutions.

But what we're proposing here is really the merger of science and common sense, because science can say that you could take a long time to resolve certain uncertainties with a drug, and it could take generations for some of it. But you've got to use common sense, because people on therapies need to know things from time to time--caution, don't take with another drug; warning, if you're in this population and you're vulnerable, don't take the drug. So there is this interaction you have to have with the market, and we're trying to do that responsibly. That's what the debate is for us.

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

It may be that you're not, right now, reducing requirements at the pre-market end. I would argue, in fact, that the department and consecutive governments, not just the present but also the past government, have done all the damage they needed to do to change the pre-market surveillance to a risk management model already.

As soon as I was elected in 1997, the first thing that happened was that the Liberal health minister got rid of the one independent drug research bureau that was left to test for--get it--post-market impact. In other words, implications when a drug and a food reacted in a negative way, or a drug to a drug, or a drug and a natural health product--gone.

Scientists have had to leave the department because they stood firm and said, “We aren't going to be bullied by the government, which has been bullied by corporations, to minimize our standards and our scientific data.” So we're now at a point where all those stringent controls at the pre-market level are basically reduced to industry regulating itself.

Now you're going the next step and giving us this fancy language about either progressive licensing or life cycle stuff. I mean, as far as I can tell, these are just nice, fancy words to in fact allow government to take one more step to get rid of the Food and Drugs Act, which is founded on the precautionary principle and “do no harm”, to bring it in line with regulatory, trade, and WTO standards.

The pressures on the international front, in terms of trade, seem to be driving this. Let me give you the example, and you answer. If we have this precautionary model, how was it that we had a situation with rancid baby food on the market, where no one felt compelled to report that to Health Canada, because they were going to wait to see if someone got sick? Then when someone gets sick, they'll report it to you, and you might do something.

Now, that is a perfect example of what the government over the last 10 years has done and what your department is doing now. I would want to know where, in all of this, is the provision to ensure that we have a much more proactive response when dangerous products hit the market.

First, I don't imagine that with food we can do it all, but with drugs, at least, ensure that you have drugs that are safe before they hit the market. You've moved to self-regulation, or “let the industry regulate itself”. Vioxx is a good example. Let it on the market. It's better for the drug companies to go through all the testing and do the regulatory stuff, but let it on the market, and then pay off when someone dies, because it's cheaper for them.

You need to explain to us how this is going to be better for Canadians.

[David Lee]

The really good opportunity for you here is to talk about how we're going to responsibly lay in these instruments. These are based on science. Frankly, you would find reasons to be very proud of the rigour our scientists bring to their exercise. We actually spend a lot of time talking to them, because we need to know what the data gaps are for them, what they need to know, so they build confidence in a drug before it goes on. There's a lot that goes on in that.

I think you would have reason to feel very good about that rigour. We don't want to displace that; that's not the idea. We want to bring really good science, and that's hard to do with rules that are 40 years old and straining to keep up with the modern science, actually.

[The Chair, Conservative, Joy Smith]

I just have to let you know we have a little bit less than a minute left.

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

Okay, then I have one final question. What's the purpose of progressive licensing or life cycle...whatever...when in fact it appears that you're really trying to move new drugs more quickly to the market, and then give Canadians the confidence that something will be in place to help them once they get sick? You haven't demonstrated to us how you're in fact dealing with concerns raised previously about drugs that get on the market and aren't safe, never mind how progressive licensing is going to help that.

[David Lee]

Progressive licensing, as a premise, stands for the fact that we progress over time in our knowledge about the drug and we're seeking the best regulatory oversight and intervention as we go along. We can walk through the instruments, internationally and domestically, to get the best presence there.

As a population regulator, you get to see how drugs are behaving. Really, the premise is to use our science wisely and then support that through the architecture of regulations and framework, and that's what we're trying to achieve.

[The Chair, Conservative, Joy Smith]

Thank you, Mr. Lee.

Mr. Brown.

[Patrick Brown, Conservative, Barrie, ON]

Thank you, Ms. Chairman.

The first question, could you provide the definitions of the terms used in the post-market surveillance, so we can have that on the record for the committee—terms such as “drug medical device”, “drug review process”. Obviously the words we use are important, so it would be helpful to get your definitions.

[Meena Ballantyne]

So you're seeking the definition of post-market surveillance?

[Patrick Brown, Conservative, Barrie, ON]

Yes, if you could, and how you would define adverse reactions, natural health products, therapeutic products, pharmaceuticals.

[Meena Ballantyne]

I'll invite Dr. Turner to respond with regard to the definition of post-market surveillance.

[Patrick Brown, Conservative, Barrie, ON]

And the associated terms.

[Meena Ballantyne]

Yes.

[Dr. Chris Turner]

The definition of adverse reaction is actually found in the Food and Drugs Act, in the associated regulations. I don't have the definition in front of me, but it's a serious, unexpected, or expected reaction or response to a product that's been taken.

There is exact wording, and we can provide that to you.

[Meena Ballantyne]

Maybe I'll tell you how I look at it in terms of post-market surveillance.

Basically, when a drug or health product is out on the market, we use a variety of means to collect information on that drug's use out in the market. Through MedEffect, through our Canadian adverse drug reaction newsletter, through any of the information we get through our compliance and enforcement activities, we gather the information, we assess it to look for signal checks in terms of what the data is telling us, and we liaise with our international counterparts as well as with our provincial and territorial counterparts within Canada. From that signal detection, we decide if any action is warranted, and we act upon it.

So post-market surveillance is basically the activities that do that, which is what we do in the marketed health products directorate that Dr. Turner is responsible for.

[Dr. Chris Turner]

I'm not sure, do you want the technical terms or do you want the plain-language definitions?

[Patrick Brown, Conservative, Barrie, ON]

The plain-language definitions.

[Dr. Chris Turner]

If you want the plain-language definitions, they're in the glossary to Access to Therapeutic Products, which I think was provided to you. It's an oversight document.

For example, an adverse reaction in here is stated as the following: “Any undesirable effect of a health product. This can range from a minor effect such as a skin rash to a life-threatening one such as liver damage.” Again, that's not the technical term that's used in the regulations, where it's a “noxious and unintended response”. So it sort of depends on what you want.

The glossary also includes definitions of pharmaceuticals. For example, post-market surveillance is defined as such: “The process of tracking drugs and other therapeutic products, already approved and on the market, to assess signals and safety trends once these products are in use among a wider population.”

That's sort of what you want, right?

[Patrick Brown, Conservative, Barrie, ON]

Yes, that's helpful. And we do have copies of that.

I also wanted to touch on your revised blueprint, which was produced in early 2007. I notice that one thing that was mentioned with respect to post-market surveillance was the lack of regulatory authority in this area; inadequate collection, analysis, and dissemination of safety and effectiveness information; as well as the need to establish stronger partnerships, nationally and internationally.

Could you expand upon that a little bit in terms of what partnerships you're talking about nationally and internationally that we need to improve upon to enhance our research capacity?

[Meena Ballantyne]

We have a variety of partnerships in this country, with health care professionals; with provincial and territorial governments; with our partners such as the Canadian Institute for Health Information and the health technology body CADAS; and with international regulatory agencies as well, such as the USFDA, the EMEA, the Australian Therapeutic Goods Administration, and others. We have regularly established contacts with all these partners at a variety of levels and in a variety of fora.

The scientists, for example, go to the ICH, as was mentioned, for the harmonizing of standards. I go to Heads of Medicines Agencies meetings, where we talk about top-of-mind issues at the level of heads of agencies. I met with Andy von Eschenbach, my counterpart from the U.S., as well as the EMEA and the U.K. and 14 other countries in early December to make sure that we're all going in the right direction on whatever issue we need to work on together.

As we've said, the science across this world is the same science, and we're all facing the same problems in terms of keeping up with evolving science and technology and being able to adopt standards so that we can all do our regulatory work in a smart way. And then we retain our right, as of course each country does, in terms of the regulatory decisions we need to make based on our history, our context, our tolerance for risk.

[Patrick Brown, Conservative, Barrie, ON]

The blueprint speaks of the challenge to strengthen it. What ways are we looking at improving our current policy?