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.