International Trade Committee on Nov. 15th, 2011

[The Chair, Conservative, Rob Merrifield]

Thank you very much for that information. We'll look forward to the question and answer part of it.

We'll now move to the Alzheimer Society of Canada.

Debbie Benczkowski, the floor is yours.

[Debbie Benczkowski]

Good afternoon, and thank you for the invitation to appear in front of the Standing Committee on International Trade today.

We at the Alzheimer Society of Canada have recently had the opportunity to meet with Minister Ed Fast in Toronto, and we are very pleased that this important committee is also interested in hearing from the Alzheimer Society today. I’d like to tell you a little about who we are, what we do, and why innovation matters to the over 500,000 Canadians who have Alzheimer's disease or another dementia, and who I’m here to represent.

The Alzheimer Society and our over 150 offices across Canada provide help for today and hope for tomorrow to Canadians who are affected by this terrible disease. We offer help by providing information, support, education, and awareness about the disease, how to cope, and how to enhance quality of life throughout the continuum of the disease. We offer hope by supporting research so that we can better understand, diagnose, treat, and prevent Alzheimer's disease.

Just a few words about the size, the scope, and the implications of Alzheimer's disease. Our “Rising Tide” report—which we released in 2009, and I brought copies along for you today—projects that within a generation the 500,000 Canadians with dementia today will more than double to 1.1 million Canadians. This year, 2011, is the year that the baby boom generation turns 65, and that means our problem will just get bigger, because aging is the greatest risk factor for Alzheimer's disease.

Alzheimer's disease is a terminal disease, and people with it can live for seven to 12 years after diagnosis. The cost of providing care throughout the continuum of this disease period is enormous. It is estimated at $15 billion today, and it will grow within a generation to $153 billion. So this is not a disease we can afford to ignore. It has an overwhelming impact on the people who have it and the people who care for them.

What is the Alzheimer Society of Canada doing to help? We at the Alzheimer Society are working on a number of fronts to provide help and hope to Canadians. In addition to our appearance here today, we are also working to affect change through preparing a well-researched and factual case about incidence, prevalence, and the economic impact of this disease, provided through our “Rising Tide” data. We are working at promoting continued and increasing public interest, evidenced by media coverage of the need for a national dementia strategy. We are working at maintaining an ongoing dialogue with senior bureaucrats and federal representatives through committee appearances like this one, including the neurological subcommittee on health.

We also work very closely with our 10 provincial Alzheimer Society partners to support their efforts to inform their provincial health representatives, so that we are presenting a common voice in the health accord negotiations to improve support systems for caregivers, improve brain health through increased research, and improve the integration of health care services post-diagnosis and as the disease progresses.

Today, I want to talk to you a little bit about why innovation matters to those I am here representing. Those people with Alzheimer's and other dementias want and need access to every single piece of brilliant science that might translate into medications that help their symptoms—treatments that can make them more able to lead normal lives for the time they can, and relief from the pressure and hour-by-hour responsibility of caregiving for families. Let me explain.

Therapeutic agents that target disease modification generally require studies that are often 18 months or longer. In fact, it can take as long as 10 to 12 years and $1 billion or more in development costs to bring a therapeutic agent to patients. This often leaves only seven to nine years of patent exclusivity for the industrial sponsor to recoup its investment in the development of a new drug. If a phase three trial has equivocal results that require a second phase three trial, companies frequently abandon a promising new drug because of the loss of patent exclusivity. It's a one-shot endeavour. Already a useful drug that could help people with Alzheimer's disease may have been abandoned for lack of corporate sponsorship.

Once the patent exclusivity on a new therapeutic agent expires, it can be copied and sold by companies that produce generic drugs in the competitive marketplace forever, without the costs of research and development.

As a result, developing new drugs has become an increasingly problematic business model that discourages the development of treatments for the fatal, chronic diseases—like Alzheimer’s disease—that create the greatest demands on our medical care systems.

I have already shared the statistics for Alzheimer’s disease with you. We know that this disease has the potential to overwhelm the medical and social support system in Canada and globally within a generation if nothing is done to prevent or slow the progression of the disease.

Patent rights policies for new pharmaceutical entities require reworking if the pharmaceutical industry is to continue to develop new drugs. For instance, prolonging patent exclusivity or allowing companies to recover some of the patent time lost during trials and regulatory approval processes would incent greater investment here in Canada.

Canada should benchmark against the exclusivity policies in the U.S., the EU, and other countries to provide a modestly advantageous policy. It is crucial that Canada take a leading position in this area so that business opportunities for the pharmaceutical industry in Canada are created, with a positive economic impact on Canadian health care, job creation, and investment in research—and for our stakeholders, the hope for a cure for Alzheimer’s disease.

The brain is the body’s most crucial and complex organ, made up of 100 billion neurons or brain cells. It controls all our life functions and allows us to act, move, think, feel, and express both our humanity and our individuality. If the brain doesn't work, every aspect of your life is compromised as a result. The brain is also the least understood, and perhaps the last frontier, in research. Ninety per cent of what we have learned about the brain has been learned in the last 15 years, but researchers still have a long way to go towards fully understanding brain function.

Diseases, disorders, and conditions like Alzheimer’s are so complex that we need to, at a minimum, maintain, but also significantly increase our investment in research and development. This will give hope to Canadians affected not only by Alzheimer’s disease, but also by the array of neurological conditions for which there are only limited treatments available, for many of which we still don’t know the cause and there still is no cure.

We fear that without clear demonstration of Canada’s support, promotion, and nurturing of innovation, key partners in industry may abandon research into Alzheimer’s disease. It’s already happening in the areas of stroke and psychiatric illness. We don’t want this to happen to Alzheimer’s disease. A reconsideration of patent policies will reset the system so that these critical, unmet medical needs can once again fit within the business model of pharmaceutical research and development and make a positive impact on new job creation in the vital knowledge economy.

Now we come back to the why. We don’t know the cause or the cure, nor do we have effective treatments for the progression of Alzheimer’s disease and other dementias. For this reason, we need to level the playing field and ensure that Canadians have the same access to innovation as the rest of the world, particularly the U.S. and Europe. For those Canadians who we represent, innovation means support for more research, drug discovery, and access to clinical trials. The research and development driven by this innovation translates into the work that will identify the causes and cures for this disease.

The Alzheimer's Society would welcome strong support and partnership with government and industry to really make an impact on this disease. We are doing our part at the Alzheimer's Society, as we are the largest non-government funder of Alzheimer’s disease research in Canada. But we fear that our over 30 years and $35 million investment in supporting this research may be at risk if the scientists and researchers we have been funding leave Canada for other countries that will support their work.

We know that similar OECD countries have better access to medications than we do in Canada, including equity in access to clinical trials. Over the past 30 years, many drugs have been studied as possible treatments for Alzheimer’s disease, but few have reached the market and have only been marginally successful in treating mild symptoms. Canadian scientists are working with their U.S. counterparts in academia, industry, and regulatory agencies to discuss ways to improve predictability and probability success. We need to be ready to take up the challenge and maintain our role as international research leaders.

Let me quote from the February 2011 report of the Canadian Institutes of Health Research:

Despite having only .5% of the world population, Canada produces 5% of the world’s new knowledge in Alzheimer’s disease and other dementias, and over the past four years, 15% of the most influential publications.

We cannot afford to let that kind of momentum be stopped by the withdrawal of ongoing long-term investment in the drug development that could see a cure.

To sum up, my expertise is not in specifics of legislation or negotiations, but we at the Alzheimer Society of Canada believe that reforming intellectual property standards for medicines in Canada that are currently being negotiated in the CETA discussions will maintain our knowledge-based investments with the potential of a $12 billion boost to the Canadian economy; will position Canada as a world leader in advanced medical research and a magnet for global investments; and will result in increased chances of Canadians getting access to newer medicines available elsewhere that can treat and eventually cure Alzheimer's disease and other dementias.

Currently Canada ranks 23rd out of 29 OECD countries in terms of public coverage of new medicines. This inequity means that people with Alzheimer's disease and other dementias have far fewer chances of getting medicines that could help alleviate their symptoms and possibly slow the progress of this disease. Canadians affected by Alzheimer's disease and other dementias need to be able to have hope: hope that their complex conditions will receive the attention they deserve by legislators such as you and hope that Canada will maintain its support for research, development, and innovation.

I came here today because I want to connect the dots between the need to support innovation in Canada, which will lead to more research and development, which will translate into more equitable access to drugs and the development of effective treatments of Alzheimer's disease and other dementias in Canada.

Thank you for your attention.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

We'll open it up to questions and answers.

Mr. Côté, followed by Mr. Hiebert, go ahead.

[Raymond Côté, NDP, Beauport—Limoilou, QC]

Thank you, Mr. Chair.

My question is mainly for Mr. Skinner.

I won't hide the fact that it irritates me a little to hear the same thing again and again about protecting patents to encourage research and development in the pharmaceutical industry. For 25 years, I have been studying the economic impact and the importance of social programs, particularly in health, in relation to the gross domestic product of a country, of a government budget.

What I've been seeing for 25 years is also shown in the figures published by the OECD in 2007 for the G7 countries. I compiled these numbers, and a very clear curve is established between the control of government spending in health and the actual costs. We can see that the United States is the country that spends the most public funds, considerably more than any other G7 country, whereas in the United Kingdom, which exercises very tight control, has the lowest levels of public spending.

I will now come back to the pharmaceutical companies. The chair of socio-economic studies of the Université du Québec à Montréal published a study on the 15 largest pharmaceutical companies in the world—we are obviously not dealing with the Canadian context. This study indicates that, in general, research and development spending over a 10 or 15-year period, if I remember correctly, represents the equivalent of only about a third of marketing and administration costs.

In terms of research and development spending, I'm not saying it's a general rule, but I think that too often we unfortunately see the development of new products that are simply derivatives of existing products, products that have supposedly been improved. I'll be honest: I sometimes feel like I'm being had.

You're asking for alignment with the European rules, in the same way that we are having a speculative bubble on the stock markets. But doing this, are we not just creating a monster, a bottomless pit of money that, in the end, won't bring anything extra to my mother, for example, who has to take a collection of pills every day? In the end, what concrete outcome will this alignment bring to Canadians? Can you give us a clear answer?

[David Skinner]

Thank you.

Actually you mentioned the situation between the United States and the United Kingdom. In my example, I was using the United Kingdom as a very strong and positive model.

It goes beyond just the data protection that's afforded in the European Union for inventing new uses for established products. I'll talk a little bit about that, because it actually has something to do with my colleague's comments. In the United Kingdom, the biggest driver of cost containment is understanding an integrated health care approach that makes self-care--what people can do for themselves--a very big part of the National Health Service and so on.

The United Kingdom was a very early adopter of the idea of not just dealing with invention, which is the patent protection system, because there are two ways you can improve health care. One is through inventing new chemicals that will have a certain safety and efficacy profile. Another is by using innovation whereby you would take something basic and find a new use for it.

The beauty of having an innovation incentive through a data protection period for something that is well established is that you already know the safety profile. The product has been in use for maybe 10 or 15 years. It's gone well past its patent life. The product is no longer at a very expensive level. It's been genericized and so on. You say that you've done some research and that product that always used to be used for arthritis actually has a very good anti-hypertensive effect, and it's much safer than the current anti-hypertensives and probably will give better compliance, and so on.

If you do all that research in Canada, you will get nothing for it. You will be penalized, in fact, because the minute you invest all the money into research and into making an application, the Canadian government will say, “Thank you for that. Now your competitors may do it as well today.” In fact, they go so far as to publish the label copy and everything you as the innovator have provided.

In the European Union, however, you have one year during which the government will not allow competitors to use your data to gain market access. It doesn't mean they couldn't do so if they had their own data. But that is a very tangible health care spending effect: being able to spend less money in terms of research to find new uses for established drugs, (a) because the safety profile is already established, so you're only looking at half the equation now; and (b) if you can find a new use for an established product and you can make it available for self-care, the costs drop right through the floor because you're into an open, competitive market.

And by the way, the governments don't pay for those kinds of things. People take them, and quite frankly we're in a period now where more and more Canadians are saying, “Please help me help myself. I want to be responsible for my own health care.” We're at a very interesting point in time where Canadians--and indeed, Europeans as well--want to do more for their own health.

But unfortunately, as I pointed out in my presentation, Canadians will be at least seven years behind Europeans in terms of products they can use to lower the health care system costs and also help individuals.

[The Chair, Conservative, Rob Merrifield]

Thank you. Your time has gone.

Mr. Hiebert.

[Russ Hiebert, Conservative, South Surrey—White Rock—Cloverdale, BC]

Thank you.

Actually, that's a great segue, because that's what I want you to elaborate on, Mr. Skinner. In your opening remarks you talked about the seven-year delay and the 90-some per cent of products that were available to EU members or U.K. members, and not to Canada. Could you just elaborate on that information for the members of the committee? Just repeat what you said earlier and give us some more examples.

[David Skinner]

Sure. In the United Kingdom, when the data protection period came into play through the European Union, and even slightly before that in terms of the U.K. government's recognition that in order to have sustainable health care, people needed to be more involved in their own health care, they took the very positive approach to prospectively look at all of these very old prescription drugs that we've had for many years. They kind of knew the drugs were well characterized in terms of their safety and their efficacy. Which ones could they prospectively move into self-care status?

To do that the government requires research to show that something could be used in the conditions of a consumer going and talking to a pharmacist rather than having to go through a physician's service to make sure that everything is well directed. They could actually use it more on their own, with supportive care from pharmacies and nurse practitioners, and so on. So there was a lot of data.

That has resulted in a very long list, over time, of products that have been moved off prescription status and into self-care status. The 96% number that I referred to reflects the fact that Canada has followed along. In other words, we have many of the switches now that they had in Europe. But it has taken us at least seven years, on average, to make that similar move.

[Russ Hiebert, Conservative, South Surrey—White Rock—Cloverdale, BC]

Why?

[David Skinner]

It's mostly because of two things.

One is that companies will invest in markets where they can recoup their investment. That's the crass commercial side of it. So there's nothing in it for the company to introduce it in Canada until such time as they have basically recouped their cost in other countries; we're kind of last on the list. You could do it, but you have to wait until you've actually recovered the costs of the data requirements the government uses to make their decision, until you can sort of expand it and let your competitors come and feed off your plate.

The second part of it is that in Canada we don't have a government philosophy towards self-care. I think I mentioned recently in a speech that the last two health ministers who said that self-care was valuable and we should pursue it were Marc Lalonde and Jake Epp. That's quite a while ago, sad to say. I actually knew both of them, so I've been around a long time, and I know that there is no government self-care initiative.

So if you combine the commercial aspects, which the trade agreement can address, and the government regulatory aspects, then you can really start to fire on all cylinders, just like they do in the U.K.

[Russ Hiebert, Conservative, South Surrey—White Rock—Cloverdale, BC]

So you're saying it's the lack of incentive for these companies to export their products to Canada that causes the seven-year delay.

[David Skinner]

Yes. It's not a simple matter of just exporting it. You would have to register it for sale in Canada, so you would have to go through the same process.

We were talking about red tape reduction. For example, there's a process that one goes through to be able to decide on simvastatin, for example, one of the statins for cholesterol, and it's two years to three years of government review of your dossier. That's after three or four years of the research that you've put in to try to support that application.

Then, when it hits the decision point and the lead investigators in the government say it's suitable for this switch and they need to remove it from their list of schedule F products--the list of prescription drugs--there's another whole two years' worth of the Canada Gazette, part I, the Canada Gazette, part II, and all of these machinations beyond when the decision is made, to eat up an extra two years of time and give your competitors that much more time to catch up to you. The standpoint we look at is that there are a number of regulatory issues that can assist, but even if all of them went away, we would still not eliminate that gap between Europe and Canada. We would just shrink it.

[Russ Hiebert, Conservative, South Surrey—White Rock—Cloverdale, BC]

Ms. Benczkowski, you talked about extending the patent life protection to encourage investment in research and innovation. How long do you think it should be extended? Do you have a number?

[Debbie Benczkowski]

I don't pretend to be an expert in how long a patent life should be extended. I guess what we are saying is that the access piece is most important to people with Alzheimer's disease, and we're actually just saying that the playing field should be levelled with what is already occurring in the EU and the United States.

[Russ Hiebert, Conservative, South Surrey—White Rock—Cloverdale, BC]

You also mentioned that we were ranked at 23 out of 29 OECD countries.

[Debbie Benczkowski]

Yes.

[Russ Hiebert, Conservative, South Surrey—White Rock—Cloverdale, BC]

Are you saying that most of those countries have better medicinal coverage than we do?

[Debbie Benczkowski]

Yes. That's a report that was prepared by Rx and D. It's called the “International Report on Access to Medicines” and it is from 2010. For drugs for mental illness, which is where the Alzheimer's disease drugs are ranked within that group, they were ranked at 27 out of 29 in terms of access for Canadians to those drugs.

[Russ Hiebert, Conservative, South Surrey—White Rock—Cloverdale, BC]

So it was not to all drugs; it was just to Alzheimer's?

[Debbie Benczkowski]

Yes.

[Russ Hiebert, Conservative, South Surrey—White Rock—Cloverdale, BC]

I see.

For both of you, to wrap up, how do you see our negotiations with the European Union in this trade agreement impacting your industries?

[Debbie Benczkowski]

I guess what I said is that I think it's most important that Canada maintain our investment in innovation and research and development. That is where people with Alzheimer's disease and people who are affected with neurological disorders.... It has the least success rate in terms of having drugs that treat the disease and will cure the disease. We're looking for equitable access for Canadians to the same drugs that are available in those markets, and the comparable ability to promote and support our investment in research and development and innovation in Canada, so that it doesn't leave Canada.

I also talked about the Alzheimer Society's investment in research. We feel very strongly about the investment we have made in research, which has been based on the donations of ordinary Canadians over the last 30 years. That's how we fund research at our society. We feel very strongly that our investment is at risk if innovation is not encouraged to the same extent in Canada that it is in the EU and the U.S. We're afraid that those researchers we support, and that we want to support, those young researchers that we want to bring along and are going to help us find the causes and cures of this disease, will leave Canada, because there will be better fields afar in other countries for them to do their research.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

I'll ask Mr. Skinner to answer that because it's a broad wrap-up question. If one of the other questioners...? Our time in this segment is gone.

Mr. Easter.

[Wayne Easter, Liberal, Malpeque, PE]

If you want to answer it now, go ahead.

[The Chair, Conservative, Rob Merrifield]

Okay. Go ahead.