Thank you, Madam Chair.
Good morning. Bonjour.
On behalf of the Patented Medicine Prices Review Board--and we will call ourselves the PMPRB from here on out, as it is a lot easier--I am pleased to have this opportunity to appear before this committee to discuss the work of the National Prescription Drug Utilization Information System, also called NPDUIS. These acronyms are in our jargon, and if they become part of your jargon, we'll just use those acronyms if it's okay.
With me today is Barbara Ouellet, Executive Director of the PMPRB. Following my opening remarks, I will be pleased to respond to any questions you may have.
Permit me to preface my comments today by offering a very brief overview of the PMPRB's role and mandate. We appeared before this committee last year, and many of you have probably heard these next comments, but I see there are new members sitting around.
The PMPRB was established by Parliament in 1987--we've just celebrated our 20th anniversary--under the Patent Act as an independent quasi-judicial tribunal. Although part of the health portfolio, the PMPRB carries out its mandate at arm's length from the Minister of Health.
The PMPRB has a dual role. The first part of that role focuses on the PMPRB's regulatory function, which is to ensure that prices charged by patentees for patented medicines sold in Canada are not excessive, thereby protecting consumers and contributing to overall Canadian health care. This involves the review of prices of more than 1,100 medications. So every year we have 1,100 or so medications under our jurisdiction, and each year, on average, we have 75 new medicines that come under our umbrella.
Pursuant to the Patented Medicines Regulations, 1994, patentees file information on their patented medicines sold in Canada, including on pricing information. In the event that the price of a patented medicine appears to be excessive, the Board can hold a public hearing and, if it finds that the price is indeed excessive, it may issue an order for the reduction of the price to a non-excessive level and for the offset of the excess revenues accrued by the patentee.
Our reporting role constitutes the second part of our mandate, and I believe this is mostly what you're interested in today. Under this role the PMPRB reports on pharmaceutical trends of all medicines and on research and development spending by pharmaceutical patentees, hence contributing to informed decision- and policy-making. The PMPRB reports annually to Parliament through the Minister of Health.
In addition to these reporting responsibilities, under section 90 of the Patent Act the Minister of Health has the authority to direct the PMPRB to inquire into any other matter.
In October 2002, following approval by the Federal-Provincial-Territorial Ministers of Health of a Business Case for the implementation of the National Prescription Drug Utilization Information System (NPDUIS), the Minister of Health directed the PMPRB to undertake specific areas of activity related to this new system.
NPDUIS is conducted through a partnership between the PMPRB and the Canadian Institute for Health Information--and you've just heard Ms. Yeates explain her role in all of this. CIHI is responsible for the creation and management of a database of individual public drug plan claims-level data and produces reports of broad interest to stakeholders, while the PMPRB undertakes most analyses of trends in pharmaceutical prices, expenditures, cost drivers, and key policy-relevant questions as described in the business case and endorsed by a steering committee composed of participating federal-provincial-territorial drug plan managers. All jurisdictions are currently participating except Quebec. Ultimately, NPDUIS is a tool to inform and support decisions on drug utilization, cost trends and projections, and overall policies of federal-provincial-territorial drug reimbursement programs.
The work of NPDUIS is not directly linked to Health Canada’s responsibility for post-marketing surveillance of pharmaceuticals; however, NPDUIS does involve a number of complementary activities.
NPDUIS was originally envisaged to provide a range of important and objective information on: aggregate drug cost and utilization trends as well as factors driving drug utilization, using nationally standardized indices, prescribing patterns, and potential impacts on drug plan budgets from new, or about to be launched, drug products.
Since the inception of the NPDUIS, the PMPRB has released a number of publications under its NPDUIS analytical studies series, the most recent of which include: Pharmaceutical Trends Overview for selected provinces and First Nations, published in June 2006, which examined expenditure and price trends among public drug plans; Guidelines for Conducting Pharmaceutical Budget Impact Analyses for Submission to Public Drug Plans in Canada, from May of last year, which set out best practices, tools, and methodologies for use by the pharmaceutical industry in predicting the potential financial impact of introducing a new pharmaceutical as part of its submission to a public drug plan for purposes of obtaining the plan’s agreement to list the drug on its formulary and provide reimbursement for beneficiaries; and the New Drug Pipeline Monitor, June 2007, which, on an ongoing basis, identifies and summarizes information on new drugs that are expected to be launched in Canada within the next two to five years that could potentially have a significant impact on federal, provincial, and territorial drug plan expenditures.
A list of additional NPDUIS publications and information can be found on both the CIHI and PMPRB Web sites.
NPDUIS projects currently underway include a new edition of the Pharmaceutical Trends Overview Report and a Methodology and Tool for Forecasting Drug Plan Expenditures.
With respect to the forward agenda for NPDUIS, last week the federal-provincial-territorial NPDUIS steering committee discussed potential research priorities for 2008 and 2009. These include financial implications for public drug plans of long-term demographic shifts, high-cost claimants, methodologies to identify prescribing patterns and track uptake of new drugs, indices to measure trends in drug therapy costs for major health problems, drug utilization relative to expenditure limitation arrangements, pharmacy dispensing fees, and rapid response for ad hoc requests.
The partnership between the PMPRB and CIHI and the collaboration with federal-provincial-territorial drug plans through the steering committee make NPDUIS a valuable resource that provides policy-makers with information and insights regarding Canada’s public drug reimbursement programs. For its part, the PMPRB is committed to making this partnership as successful and productive as possible, and to the best of its ability, using objective analytical expertise to analyze questions of public importance.
The PMPRB saw its reporting role further evolve in 2005 when it was directed by the Minister of Health, on behalf of himself and his provincial and territorial colleagues, to also begin monitoring and reporting on the prices of non-patented prescription drugs.
Funding for this initiative and for NPDUIS has been provided separately by Health Canada, but both activities will be merged under the umbrella of NPDUIS beginning in 2008-2009. This means that, to the extent possible and appropriate, future NPDUIS studies would analyze issues from the perspective of both patented and non-patented drugs.
Thank you. I would now be pleased to address any questions you may have.
That's all, Madam.