Health Committee on June 20th, 2006

[Brett Skinner]

On the basis of that observation...which is true; generics do not spend as much developing their products. In fact, from the research I've seen, the average cost of developing a new drug is more than $800 million U.S. One in 10,000 molecules discovered actually makes it to the market as a successful drug product, and only 30% of the ones that do make it either match or exceed enough revenue to cover those R and D costs.

With that in mind, for generic drugs it's only a few million dollars, at best, to copy somebody else's invention. You would expect their prices to be lower, but in fact we find them to be much higher. Ontario reimburses these drugs at 70% of the price of a brand-name drug. Clearly their R and D costs are not 70% of the R and D costs of a brand-name product.

[Rick Dykstra, Conservative, St. Catharines, ON]

So is a company like Apotex a generic, or is it a research and development company?

[Brett Skinner]

Apotex is a generic company.

[Rick Dykstra, Conservative, St. Catharines, ON]

It is generic. Okay, thanks.

[The Chair, Conservative, Rob Merrifield]

Thank you.

We'll go to Ms. Dhalla.

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

To follow up on what Mr. Batters and Mr. Dykstra were saying with regard to pharmaceuticals and the differentiation in price, how do you think that not having data protection for the industry has harmed it in any way or has had any type of negative effect?

[Brett Skinner]

I'd be happy to answer that one. Patent protection is granted to a product in exchange for the release of its data. So that would not normally occur without patent protection.

Because that data is made public, that is the data set that is used by generic manufacturers to copy the inventions of brand-name companies. The argument behind it is that early access to that data allows the early development of those drugs, and in some cases, the early violation of patents, which are then challenged in the courts, and then there is some gaming in the courts that goes on.

That is the link with data protection. I think there are some good arguments to be made for extending data protection, but I'd like to study the question further before drawing any definitive conclusions.

[Dr. Ingrid Sketris]

Can I just comment on the way the metrics are coming out? Often what you hear about is the cost of a generic drug and the cost of the brand-name drug and so on, but I think what's really critical is how much it costs to treat a patient with hypertension or with diabetes. We've done some work looking at the cost to treat cholesterol in Nova Scotia compared with Australia. So as you explore this area further, think about how much it costs to treat the disease condition, as well as about the type of drug.

[Dr. Barbara Mintzes]

I would like to add a note on innovation and patent protection. What we're seeing more and more is the patenting of what are called isomers of existing molecules. The molecule has two orientations in space. The patent is due to expire and a new drug, which is one of the orientations in space of the same molecule, but with a very different brand name, is then produced by the same company. So it's really an evergreening of the patent.

Nexium is the cause célèbre of that. It's a lot like Lastium, but it's one of the leading drugs in terms of spending. So you have to ask--going back to how we are treating patients--whether this is actually meeting the needs of as many patients as possible for a specific sum of money.

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

I think it is not only in terms of meeting patient needs but also in terms of governments and ensuring that health expenditures.... As you mentioned in your report, Mr. Skinner, they are catching up and are going to make up over half of the total revenue sources by--what was it?--2022. So in the era of globalization, I think it's important that we invest in research and development and innovation for the pharmaceutical industry.

[The Chair, Conservative, Rob Merrifield]

If Ms. Keeper has a question, she should ask it now.

[Tina Keeper, Liberal, Churchill, MB]

Yes, thank you.

I want to pick up on a term you used, Dr. Mintzes. You used the term “medicalization of life”, and I think this is on the topic we're talking about. I would just like to know, in a quick, general way, what the impact has been in terms of pharmaceutical companies, in terms of what you're talking about--patents and development and this evergreening effect--on Canada.

[Dr. Barbara Mintzes]

In terms of medicalization, what I mean is the provision of medical care--and it plays out particularly in terms of drug treatment--for people who actually don't have an illness, or who are in a situation where they're dealing with normal life, and where there isn't evidence that giving what they have a diagnostic category, a diagnostic name, and then treating it with drugs is actually going to provide a health benefit.

Internationally, we're seeing an increase in the per population volume of prescription drug use. And one of the sides of the national pharmaceutical strategy--my understanding is that it is one of the key aspects--is to try to follow up on drug safety and effectiveness once drugs are on the market. That partly came out of the Vioxx scandal, because you had evidence from the clinical trials that thousands of people had had extra heart attacks, but nobody had noticed because they were mainly looking at elderly people and nobody had followed up. You've had specific follow-ups of stomach bleeding in Ontario and the rate going up after the COX-2 inhibitors came in, because so many more people started using those drugs who weren't using them beforehand.

So I think the concern is that we might be causing more harm than benefit in an individual patient, and that people are often very unaware of just how much benefit they can or cannot expect to get from drug treatment. I don't know if that answers your question.

[Tina Keeper, Liberal, Churchill, MB]

Am I out of time?

[The Chair, Conservative, Rob Merrifield]

Yes, that's our time.

Our time for this segment is gone. I want to thank you for coming. It's always a balancing act between the testimony from Mr. Skinner, which says we save $7 for every $1 that's in pharmaceuticals--I think we all appreciate their benefits--and the testimony from the research from Ms. Sketris with regard to 60% of those who fall are on Valium or a like product, and the misuse of that. So it's that balancing act that we really have to discern in Canada and that the committee will have to take a serious look at.

I'll allow one more comment.

[Dr. Barbara Mintzes]

It's just that Lichtenberg's research is based on lousy methods. Nobody quotes it outside the pharmaceutical industry and pharmaceutical funding.

If somebody gets morphine near the end of life, that's considered an older drug and therefore more likely to kill them. If they get an allergy drug when they're not near the end of life, that's considered something that's life-saving. It's not defendable in terms of methods.

[Brett Skinner]

Actually, Lichtenberg's work has been replicated by others attempting to refute it, and they found exactly the same results.

[The Chair, Conservative, Rob Merrifield]

Therein lies the dilemma.

With that, I'll call the end of this segment.

I want to thank the witnesses again for coming forward. We will be able to ponder whether we continue with this study in the fall or not. Thank you very much.

Now we will move on to some of the other issues. Before we go into the in camera session, which will deal with the report, there are a couple of issues. First, we want to deal with a notice of motion that has been given to the committee.

But before that, we have the opportunity to nominate Weldon Newton as the president of the Hazardous Materials Information Review Commission. To proceed with that, if it is the will of the committee, we need a motion to make that appointment. We will entertain a motion and then we'll debate that motion.

Does anyone wish to make that motion?

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

I'll do it.

[The Chair, Conservative, Rob Merrifield]

We have a motion by Ms. Dhalla. Is there any discussion on the motion?

[Dave Batters, Conservative, Palliser, SK]

With all the commotion of people leaving the room, can you just refresh...?

[The Chair, Conservative, Rob Merrifield]

This is a certificate of nomination for Weldon Newton with regard to....

I believe we've passed it around to you, so you have it in front of you.

The decision is to make the appointment at the present time and not necessarily call him before the committee.

It's moved by Ms. Dhalla.

[Dave Batters, Conservative, Palliser, SK]

Is that seconded by Mr. Fletcher?

[The Chair, Conservative, Rob Merrifield]

Yes, that's right.

We want to make sure everybody is clear on the motion, prior to it....

[Ruby Dhalla, Liberal, Brampton—Springdale, ON]

Before the vote on that motion, can we get some information on the individual, to make an informed decision?