Evidence of meeting #25 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was drugs.
A recording is available from Parliament.
12:10 p.m.
Conservative
Steven Fletcher Conservative Charleswood—St. James—Assiniboia, MB
Madam Chair, perhaps I could just make a comment. I'm impressed with the interpreters on that. They were very good. That was a lot of information given very quickly.
12:10 p.m.
Conservative
The Chair Conservative Joy Smith
We were absolutely amazed.
I was concerned about you. You're awesome. Thank you.
Give them a hand, everybody.
12:10 p.m.
Some hon. members
Hear, hear!
12:10 p.m.
Tom Brogan President and Chief Executive Officer, Brogan Inc.
Thank you very much. I'm honoured to be able to present to this committee, and I thank you for inviting us.
l was employed by the federal government between 1974 and 1989, and l was the chief policy analyst on the 1987 Patent Act amendments. Those created the Patented Medicine Prices Review Board and curtailed the use of compulsory licensing. l was acting director at the Patented Medicine Prices Review Board between 1987 and mid-1989, when I left to create a private company, Brogan Incorporated. The idea was to bridge the gap between government and the private sector. I saw when I was in government that there was not a lot of communication of much substance. So we've tried to create an empirical base on which both parties could communicate on equal grounds.
It was not planned at that time, but we now have the largest prescription database in the country. We have somewhere around 1.5 billion prescriptions in our database, coming from a very large number of sources. We have140 dedicated professionals analysing and reporting on these data. These data obviously permit very extensive and complete analysis on a large range of issues, and they do so without jeopardizing patient privacy, since we don't have a patient ID. There's a scrambled code put in place of any direct patient identifier. These are the kinds of data that Dr. Dal Pan was talking about...owned by the private sector in the U.S.
Over this period of time, we've pioneered the analysis of administrative drug data, including beating the Americans to the punch, which I'm proud to say. We've already done many of the current and proposed new proposals that you heard about from previous witnesses. These analyses have been used by government, academia, and industry to inform decisions about drug coverage and utilization. We've conducted a number of studies measuring drug cost by age groups, regional variations, and a detailed analysis of high-cost claimants. By the way, some of that is provided in a briefing document I provided earlier.
Recently we completed an analysis of the Alberta seniors drug plan, a project we worked on in conjunction with the Alberta Ministry of Health. Another study looked at drug use by 1.2 million Canadian children. This is the largest study on pediatrics ever done anywhere from an administrative database. You've probably heard about NPDUIS. That's a simple re-creation of what we have already created. It's been under way at an exorbitant cost. The government could have bought something right off the shelf.
l think the committee will see there is a direct relevance to our activities and the questions it quite astutely has put forward for examination. Specifically, l would like to speak to just a few points: capacity for monitoring; surveillance and research; public access to information; and adverse reaction reporting.
We've developed a significant database and expertise in handling these complicated and large data sets. There is no risk to patient privacy. However, the government does not make adequate use of this capacity for monitoring, for surveillance, or for research. I think too much effort is put into replicating what already exists.
While the knowledge derived from our existing database is powerful and can be used for the better management of health systems, we're hampered by limited access to data. While we have the largest prescription database, we don't have data from every provincial government. Some government officials have been resistant to making these kinds of data available, and there's no clear reason for their position. This means valuable information for the management and improvement of the health care system is not being used.
I will give you a specific example to explain. We've discussed a data-sharing arrangement with all the cancer agencies in the country, and the participants are very interested in creating a central repository. However, it's not an unwillingness but a lot of effort is required for them to extract the data to send to us. While we have one province on board now, and we're looking for several others, it's a very slow and tedious project. This means that there is no comparative information on the use of cancer therapies across the country, little data on the effectiveness of treatments, and of course little data on adverse events rates in real life.
I don't want to dismiss the value of clinical trials; this is an add-on to clinical trial information.
The most powerful information will come from an integrated database where you're putting together all aspects of a patient's health resource use—again, without knowing who the patient is—and that would be lab tests, doctor visits, hospital visits, drug use. This is not difficult to do, but it is a very large project. Everything is there to have it done, but there has to be a willing spirit to make it happen.
We hope this committee would encourage Health Canada, for one, to make more use of the private sector in monitoring surveillance and research in all areas of health care. There is a capacity among private sector participants to dramatically expand what government agencies are trying to accomplish.
We would also suggest that this committee encourage governments that hold data to share this with the private sector. A more broadly based data set would allow us to extend our analysis significantly, and the more eyes examining the data, the more insights that will be developed. Of course, this will be done under the privacy and confidentiality rules that prevail now. I believe that all of this information can play a pivotal role in managing many aspects of the health care system.
Thank you, Madam Chairman.
12:15 p.m.
Conservative
The Chair Conservative Joy Smith
Thank you so much. We appreciate your presentation this morning.
We're going to go into the first round, and we will begin with seven minutes per person, for the question and the answer.
We'll go to Ms. Kadis first.
12:15 p.m.
Liberal
Susan Kadis Liberal Thornhill, ON
Thank you, Madam Chair.
Welcome to our guests.
To Mr. Ménard, are you familiar with the new proposed government legislation, Bill C-51, regarding life-cycle approach and progressive licensing? What is your position on this? Do you feel it will increase or decrease product safety for Canadians?
12:15 p.m.
Attorney and Specialist in Medical Law, Ménard, Martin, Avocats, As an Individual
The life cycle approach offers interesting perspectives. To date, we have worked with drugs until they get to the market after which we play a very minimal role. Conceptually, this is a good approach, but in concrete terms, what will we really monitor and look at? What kind of information will we require from pharmaceutical companies? I think it's important to look at these matters. The overall idea is a good one, but we'll have to implement mechanisms to increase transparency and accountability, and provide better information in order to protect the public. Clearly, we will now obtain more information from the government. Consequently, we'll be able to go further. However, we'll have to see how this will benefit the public.
12:20 p.m.
Liberal
Susan Kadis Liberal Thornhill, ON
Thank you.
I have another question.
From your perspective and experience, would you say part of the reluctance of medical professionals in reporting is due to fear of being sued? How prevalent are lawsuits in Canada regarding medical malpractice specifically due to adverse effects from medication?
12:20 p.m.
Attorney and Specialist in Medical Law, Ménard, Martin, Avocats, As an Individual
Drug-related lawsuits that can be filed against doctors are often due to a failure to advise patients of known complications, which might have influenced the latter's choice. It may also be the failure of the doctor to prescribe the right medication, or he may be sued for prescribing the wrong one.
In the case of prescription drugs or drugs being marketed with specific indications, it is not unusual for doctors to develop what are called off-label uses, meaning for other reasons than the reasons for which the drug was originally designed. There is some risk associated with this, but that is not the reason why doctors are not reporting complications. In general, doctors are saying that they are not reporting them due to a lack of time. They wonder whether they should treat the patient or fill out a form. Furthermore, numerous doctors know little about the post-approval drug monitoring system. Under Quebec legislation, they are now required to report complications to the government. Even if this is a statutory requirement, it is still difficult.
12:20 p.m.
Conservative
The Chair Conservative Joy Smith
Thank you, Mr. Ménard.
Ms. Kadis, I understand that you and Dr. Bennett wanted to share time.
12:20 p.m.
Liberal
12:20 p.m.
Liberal
Robert Thibault Liberal West Nova, NS
Thank you, Mr. Brogan.
You're talking about administrative data. Could you quickly define that? Is that data you're getting from secondary sources--for example, from insurance companies?
12:20 p.m.
President and Chief Executive Officer, Brogan Inc.
I don't want to quote the number of sources, but it would be a source like insurance company payments or payments made by a private drug plan or a government drug plan—we receive both—or from a hospital database.
12:20 p.m.
Liberal
Robert Thibault Liberal West Nova, NS
Would the data include any information on the effectiveness of the pharmaceuticals in question?
12:20 p.m.
President and Chief Executive Officer, Brogan Inc.
Not directly. This is a supplementary use of the data, a supplement to adverse reactions or effectiveness. In quite a large number of cases, not all, you can look at the full range of drugs the patients have been on, how soon they stopped the medication, and other things that might raise a flag that there's something going on.
12:20 p.m.
Liberal
Robert Thibault Liberal West Nova, NS
But you would only know how long when they stopped billing for the pharmaceutical, not necessarily when they stopped taking it. If they took it at double the rate for half the time, that type of use, you wouldn't know.
12:20 p.m.
President and Chief Executive Officer, Brogan Inc.
We do know how many pills they acquired over a period of time. We purchase pharmacy data, and when you look at it, you see that Canadians are good at using—
12:20 p.m.
Liberal
Robert Thibault Liberal West Nova, NS
I'd like to get into the question of off-label use. That's one of the areas we found interesting, especially when we came to children, because very few clinical trials are done on minors. In looking at the off-label use of drugs, did you differentiate with respect to minors, children?
12:20 p.m.
President and Chief Executive Officer, Brogan Inc.
Yes, we did. In that study, we looked at it.
12:20 p.m.
President and Chief Executive Officer, Brogan Inc.
In the case of Viagra, 100%. For other drugs, I can't tell you.
12:20 p.m.
President and Chief Executive Officer, Brogan Inc.
There is quite a legitimate use for it.