:
Thank you, Mr. Merrifield.
Bonjour. Good afternoon.
I'm pleased to have my first opportunity to appear before you as the chairperson of the PMPRB. I was appointed as chair last summer, but I've been a member of the board for almost two years now. Today we're going to discuss main estimates and undoubtedly a number of other issues of interest to committee members relating to the pharmaceutical pricing and pharmaceutical environment in Canada.
It's been almost two years since we appeared before this committee. Two years ago the then-acting chair, Réal Sureau, appeared before you in a similar capacity.
With me today is Barbara Ouellet, the executive director of the PMPRB. Following my opening remarks, we would be pleased to answer any questions you might have.
At the outset, please permit me to provide a bit of context concerning the role and mandate of the PMPRB. It is not the most widely known organization within the Government of Canada, but we believe we do significant work.
We were established by Parliament in 1987 under the Patent Act, and the PMPRB is currently part of the Health portfolio. However, as a quasi-judicial, independent body, we carry out our mandate at arms' length from the Minister of Health.
The PMPRB has a dual role, which includes both regulatory and reporting responsibilities. In terms of the first of these, the PMPRB reviews the prices of more than 1,000 existing patent medicines already under our jurisdiction, to ensure that the prices are not excessive.
At present, the PMPRB also is completing its review of 100 new medicines that came under the board's jurisdiction during the last year, 2006. As part of the PMPRB's regulatory responsibilities, the staff carries out investigations in cases where non-compliance has been identified. When we refer to non-compliance, we're referring to guidelines that we have developed, and I'll say a few words about those a little later.
Over the past 18 months, the PMPRB has issued eight notices of hearing into prices of patent medicines that appear to be excessive. The board staff is currently involved in some additional 33 ongoing investigations.
[Translation]
The second part of our mandate is our reporting role. The Board reports annually to Parliament, through the , on its activities and on pharmaceutical trends relating to all medicines. We also report on the R&D spending by pharmaceutical patentees.
Our report for 2006 will be submitted to the Minister of Health on May 31 next. Under section 90 of the Patent Act, the minister also has the authority to direct the Patented Medicine Prices Review Board, the PMPRB, to inquire into any other matter. Under this provision, the minister has twice directed the Board to carry out additional initiatives.
In 2001, federal, provincial and territorial Ministers of Health announced the launch of the National Prescription Drug Utilization Information System. Working in partnership with the Canadian Institute for Health Information, known under the acronym CIHI, the Board was charged with conducting an analysis of price, utilization and cost trends for prescription drugs.
[English]
Some examples of our current activities in the area of the national prescription drug utilization information system--our acronym is NPDUIS--include an analytical report on pharmaceutical trends; a study to forecast pharmaceutical costs; the development of a methodology and reporting guidelines to assist the pharmaceutical industry in meeting requirements of federal, provincial, and territorial drug plans for more transparent budget impact analyses; and the monitoring of new drugs in the pipeline that are expected to potentially have an important impact on drug therapy and underlying drug plan budgets.
On November 2, 2005, this role was expanded further when the federal Minister of Health, on behalf of the FPT ministers of health, directed the PMPRB to report on prices of non-patented prescription drugs, usually referred to as mostly generics.
This new responsibility in support of the national pharmaceutical strategy has resulted in two reports issued by the PMPRB to date. The first one is “Canadian and Foreign Price Trends”, and the second is “Trends in Canadian Sales and Market Structure”. In April this year, the third study on the market of new off-patent drugs will be released. This report tracks market development for drugs immediately following their patent expiry. Basically, we want to know if they're going to be picked up by generic manufacturers or not or simply abandoned. The fourth report of the quarterly series will focus on non-patented single-source drug prices.
I would like to focus for a moment on a couple of matters reflected in the main estimates that demonstrate the evolving nature of the environment in which the PMPRB finds itself now and how this is affecting our work. Figures for 2007-08 along with those of the previous fiscal year 2006-07 show that the total PMPRB budget has increased from $6.5 million to $11.5 million, which is almost double. It's an eye opener, and there are reasons for this. It would not be unreasonable to ask why such substantial change has occurred.
There are several factors that have contributed to this budgetary increase. These additional funds were allocated to the PMPRB to enable the board to conduct an increased number of public hearings to determine whether certain patented medicines were or are being sold in Canada at prices that may be excessive. In addition, these funds were needed to enable the board to undertake a comprehensive review and public consultation on our excessive-price guidelines.
These guidelines were last revised in 1994--so some 15 years ago. Although not binding on the board and on the patentees, the guidelines provide clear, predictable, and transparent information on how the prices of patented medicines will be reviewed and have historically greatly facilitated voluntary compliance in setting prices that are not excessive.
[Translation]
With respect to the matter of public hearings, I have personally taken decisions to issue eight Notices of hearing in the last 18 months. By way of comparison, this number is equal to the total number of notices of hearing issued by the Board going back to its inception in 1997 through to 2005. Moreover, of these eight notices of hearing issued between 1987 and 2005, only one full hearing was held, five were resolved through voluntary compliance undertakings, while two others are pending.
This relatively recent increase in the number of notices of hearing may not necessarily represent a longer term trend, but is a departure from the previous history of the Board. It is the reality currently being faced by the PMPRB as it seeks to ensure that patentees' prices for all patented medicines sold in Canada are not excessive.
[English]
One could speculate on the reasons for an increase in the number of hearings--for example, the shift in the drug pipeline away from blockbuster new chemicals to more incremental innovations. In part because of notices from third parties about price increases after a period of considerable price stability and our own experience with the shift toward more hearings, the board is currently undertaking a comprehensive review of its excessive-price guidelines. I'd like to remind you that in past years these guidelines were very effective in ensuring compliance; there were very few hearings. The pharmaceutical manufacturers seemed to follow them.
This review has involved a process through which we are seeking to address complex and wide-ranging issues. It is not a process that can be accomplished quickly or by cutting corners. Analysis has required a phased-in approach that reflects the broad scope of the review itself.
The primary purpose of the review of the guidelines is to ensure that the PMP's excessive-price guidelines appropriately reflect the board's interpretation of the price determination factors set out in the Patent Act and that the board's price review process remains relevant and responsive to the current pharmaceutical environment.
At the same time, we must make every effort to make certain that this review is carried out in a transparent and effective manner that encompasses opportunities for input from all interested stakeholders. This is a significant, important, and timely review. It addresses issues that go to the heart of price determination.
Here are two examples, to name a few. The first is the categorization of new drugs. We determine price tests, depending on which drug category a particular medication fits into. Some stakeholders feel they no longer adequately recognize the current type of innovation in the pharmaceutical environment. Then the price tests are used to determine if the price of a patent medicine is excessive or not. Concerns have been expressed that these tests, at one extreme, may not result in an appropriate price premium for the value of the drug in question, and at the other extreme are a major cost driver of public drug plans.
[Translation]
From our core regulatory and reporting functions, to our expert analytical support for F/P/T Ministers of Health, to major undertakings such as the review of the excessive price guidelines, the Board is engaged in a broad range of activities that ultimately touch the lives of all Canadians. We are committed to carrying out these responsibilities in a manner that is transparent, effective and accountable.
[English]
On behalf of the PMPRB, those were my opening comments. I would be pleased to answer any questions--and if I don't have the answer, she does, we hope.
:
Thank you very much, Mr. Chair.
[Translation]
It is a pleasure for me to be here before the committee once again.
[English]
I was last here in May of 2005, when the committee recommended my nomination as CIHR president for a second five-year term.
[Translation]
Thank you.
[English]
I would like to start by acknowledging and introducing two officials, who are my colleagues, with me here today: Jim Roberge, CIHR's chief financial officer; and Dr. Pierre Chartrand, CIHR's vice-president for research. I may ask them to answer any of your tough questions that come up today.
On Monday I spoke to the Canadian Club in Toronto. I spoke there about the revolution that's taking place in health research; about the importance of research generally, and particularly health research, to Canada's future; and about the exciting new opportunities for improving health.
These changes are resulting in changing views of human health and health care in the 21st century, and it was in the context of this changing landscape that CIHR was created in June 2000 by Parliament. Since then, we have moved quickly and deliberately from our origins as a largely reactive biomedical granting council to an outcomes-driven, excellence-based strategic research organization capable of capitalizing on and leading this revolution. I think it's fair to say we are no longer a granting council.
Today we have 13 health research institutes, each led by an internationally recognized scientific director, and each advised by 13 institute advisory boards, each made up of 18 individuals from across Canada and abroad. Over the last year, many of our scientific directors have appeared before this and other parliamentary committees to assist in developing evidence-based policies to address the health challenges facing Canadians.
For example, Dr. Diane Finegood, who is no stranger to this committee, the scientific director for our Institute of Nutrition, Metabolism and Diabetes, has discussed the latest research and knowledge translation activities on obesity, including, importantly, childhood obesity—and of course I will come back to that.
Dr. Anne Martin-Matthews, the scientific director of CIHR's Institute of Aging, spoke on the implications of Canada's aging population on all kinds of things, including the health care system.
Dr. Rémi Quirion, who's the scientific director of our Institute of Neurosciences, Mental Health and Addiction, has appeared on issues such as autism, fetal alcohol syndrome, and mental health.
As you may know, CIHR has a strategic plan that was the culmination of broad national consultations with health researchers and other stakeholders. Within that plan, each of our institutes has their own strategic plan from which research agendas have been implemented on everything from obesity, to wait times, palliative care, aboriginal peoples' health, training the next generation of researchers, health in children, cancer, and environmental issues.
Beyond our development as an organization, the creation of CIHR has had a profound effect on Canadian health research, and increasingly and most importantly, on Canadians. Today, CIHR-funded researchers are working in all health-related disciplines, from the biosciences to engineering and bioinformatics, to the humanities and the social sciences.
We are leveraging CIHR funding through many important new partnerships, both within Canada and internationally—and I'll mention one shortly—which have contributed well over $500 million in the support of common national and international priorities in health research.
New programs in knowledge translation and innovation, such as CIHR's “Knowledge to Action”, “Proof of Principle”, and “Science to Business”, have been developed to fill key gaps in the pipeline from academia to the health system, to the clinic, to the marketplace, and to Canadians.
New companies and new health policies are already in place because of these new, innovative programs. School children in Saskatoon and Kahnawake are involved in intervention and research focused on diet and diabetes research. I was very pleased that you mentioned the work going on in Kahnawake in your recent report that came out two days ago.
As another example, Amorfix Life Sciences was recently nominated, and actually received, a Technology Pioneer 2007 award by the World Economic Forum in Davos, the only Canadian company selected for that award. Amorfix builds on the CIHR-funded discoveries of Dr. Neil Cashman at UBC and Dr. Marty Lehto at U of T. Amorfix's business plan is to help in early diagnosis and treatment of diseases such as Alzheimer's disease.
Just yesterday, the New York Times, as well as virtually every Canadian newspaper, ran on the front page a story on CIHR-funded research comparing the efficacy of coronary stents versus drugs for heart disease. Today, in the Vancouver Sun, the Minister of Health for British Columbia, George Abbott, announced that on the basis of that research, he was going to re-examine the need for doing angioplasties for coronary heart disease.
We did a back-of-the-envelope calculation this morning, and let me just walk you through some numbers.
We spent $2.7 million over six years on that trial. That was a partnership with U.S. partners, who invested $22 million in that trial. These are the calculations: Canada does roughly 80,000 angioplasties a year, and they cost roughly $10,000 per angioplasty; so conservatively, if we could prevent only one-third of those, we would save roughly $300 million a year for Canada's health care system.
I am sure the reason the Minister of Health in British Columbia is looking at that is first because of safety issues around stents, and second because of cost issues.
Today about 30% of our funds are going to strategic initiatives that directly respond to health challenges of high priority to Canadians. These initiatives are developed and led by our 13 institutes after very broad consultation with various stakeholders and our built-in multi-partnerships with other federal departments, provincial health research agencies, the provincial and territorial ministries of health, international partners, as I've just alluded to, industry, and the health charities.
These initiatives are timely. They align with government's broader agendas and priorities. They are built on Canada's scientific strengths, and they promise to drive urgently needed improvements in Canada's health care system.
For example, after consulting with many stakeholders, our Institute of Nutrition, Metabolism and Diabetes declared obesity to be its priority area. As a result, we now spend about $20 million a year to support research, in all its translations, looking at all aspects of obesity, from the social and cultural issues to the genetic, physiological, metabolic, behavioural, and psychological.
I know that this committee is also interested in pharmaceutical policy--we just had a discussion on that--an area in which we have invested almost $20 million since 2000. For example, we fund Dr. Steve Morgan at the University of British Columbia, who has developed a very innovative drug utilization atlas that is an important first step in understanding and containing rising drug prescription costs. It is an atlas, like zip codes right across the country, of drug costs from area to area. This atlas reveals differences in the pattern of drug utilization across Canada and is providing a powerful tool for ministries as they move to contain rising drug costs.
In 2006 we embarked on a significant and comprehensive evaluation by a prestigious international review panel. That panel applauded CIHR for what's been accomplished to date, noting that Canada is setting an example to the world.
I'd like to turn some attention now to our main estimates for 2007-08.
Our main estimates have increased by a net amount of $36.9 million over last year. The CIHR grant vote has increased by $35.7 million over the previous fiscal year, and the CIHR operating expenditure vote has increased by $1.2 million.
The increase is partly due to the increase of the CIHR budget by $17 million, as presented in the 2006 federal budget, $16.3 million of which is allocated to our grants and awards for 2007-08 and $0.7 million, or $700,000, of which is allocated to operating expenditures.
Other budgetary grants and award increases include $11.6 million for Fabry's disease, $2 million for the federal initiative on HIV/AIDS, an incremental increase in the Canadian graduate scholarships program of $5 million, and new funding for pandemic preparedness research and training of $3.8 million.
Furthermore, CIHR is very grateful to have received a budget increase of $37 million in the recent federal budget of 2007. Our governing council is now deliberating on how to best allocate those funds.
As I have outlined, impressive gains have been made by health research. However, there is still a very formidable list of diseases, conditions, and health system issues for which there are no cures. More research is necessary to understand their origins and progression. Nature and social change also continually provide new challenges to our health: the emergence of new diseases like AIDS and SARS; the re-emergence of tuberculosis; cancer; obesity--again highlighted by this committee; the growing dilemma of dementia in the elderly; and autism. Most importantly, or equally importantly, building an evidence-based, sustainable, and accessible health care system is obviously a high priority for Canadians.
I know this committee is also very concerned about the epidemic of obesity among young children, and I congratulate you on your report that was released a few days ago. To me, obesity is a perfect example of the alignment of the government's concerns and CIHR's research and knowledge translation agenda. It illustrates and demonstrates the importance of solid research evidence to drive changes in policy, in practice, and in individual behaviour. That's why I think your support of CIHR and of health research has been and, I think, will continue to be so important.
Thank you. I'll be very pleased to take your questions.
:
There are a couple of parts to your question. Let me try to answer each of them.
For almost all of our programs, we don't require partnerships. We actually line up the partners ourselves. We would go to the Juvenile Diabetes Foundation, the Heart and Stroke Foundation, or a drug company and would line up the partnerships for our programs. That's the first part of the question.
The second part is about commercialization. Commercialization is a complex issue. It involves many players in a complex ecosystem. It involves venture capital, the local institutions, physical facilities for actually setting up a company, management expertise, seed capital—all kinds of things.
What we have tried to do initially is ask what our role is in that very complex ecosystem. I think our roles are several-fold. First is to fund the research—if you will, to put the oil in the ground so that it actually makes sense to have a pipeline—and secondly, to provide some early seed capital, almost, to allow some of that research to move down toward something that is commercially of interest.
We started a new program—I didn't mention it in my talk—called the proof of principle program. The proof of principle program or POP has been extremely well received by the research community and by industry as an extremely innovative program. The intent of that program is not to fund more research, but to add more value to the research, so that the researcher can go out and find a commercial partner. We don't require a partner for the POP program.
Another program, just as an example—which I did mention—is “Science to Business”. Again I think it's a very innovative program. We've recognized that there aren't enough people in this country who are familiar and comfortable both with science and with business. These are two silos. With science to business, what we're doing is taking young graduates with a PhD in research and science and in partnership with business schools in Canada providing them with an MBA, provided it's in biotechnology. That started two years ago.
I've met, actually, with a number of these students at the Rotman School in Toronto and at the Ivey School in London, Ontario. It's just a fabulous group of young people. I think as we develop a cadre of these individuals who can straddle both worlds, it'll go a long way to solving some of these ecosystem issues I've been alluding to.