HEAL Committee Meeting
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37th PARLIAMENT, 2nd SESSION
Standing Committee on Health
EVIDENCE
CONTENTS
Tuesday, September 16, 2003
| ¿ | 0905 |
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The Chair (Ms. Bonnie Brown (Oakville, Lib.)) |
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Dr. Robert Peterson (Director General, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health) |
| ¿ | 0910 |
| ¿ | 0915 |
| ¿ | 0920 |
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The Chair |
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Mr. Rob Merrifield (Yellowhead, Canadian Alliance) |
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Dr. Robert Peterson |
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Mr. Rob Merrifield |
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Dr. Robert Peterson |
| ¿ | 0925 |
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Mr. Rob Merrifield |
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The Chair |
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Mrs. Betty Hinton (Kamloops, Thompson and Highland Valleys, Canadian Alliance) |
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The Chair |
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Mrs. Betty Hinton |
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Dr. Robert Peterson |
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Mrs. Betty Hinton |
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The Chair |
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Mr. Rob Merrifield |
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Dr. Robert Peterson |
| ¿ | 0930 |
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Mr. Rob Merrifield |
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Dr. Robert Peterson |
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Mr. Rob Merrifield |
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Dr. Robert Peterson |
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Mr. Rob Merrifield |
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Dr. Robert Peterson |
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The Chair |
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Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ) |
| ¿ | 0935 |
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Dr. Robert Peterson |
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Mr. Réal Ménard |
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Dr. Robert Peterson |
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Mr. Réal Ménard |
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Dr. Robert Peterson |
| ¿ | 0940 |
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The Chair |
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Ms. Hélène Scherrer (Louis-Hébert, Lib.) |
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Dr. Robert Peterson |
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Ms. Hélène Scherrer |
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Dr. Robert Peterson |
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Ms. Hélène Scherrer |
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The Chair |
| ¿ | 0945 |
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Ms. Hélène Scherrer |
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Dr. Robert Peterson |
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The Chair |
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Ms. Carolyn Bennett (St. Paul's, Lib.) |
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Dr. Robert Peterson |
| ¿ | 0950 |
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Ms. Carolyn Bennett |
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Dr. Robert Peterson |
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The Chair |
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Mr. Jeannot Castonguay (Madawaska—Restigouche, Lib.) |
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Dr. Robert Peterson |
| ¿ | 0955 |
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Mr. Jeannot Castonguay |
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Dr. Robert Peterson |
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Mr. Jeannot Castonguay |
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The Chair |
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Mr. Rob Merrifield |
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Dr. Robert Peterson |
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Mr. Rob Merrifield |
| À | 1000 |
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Dr. Robert Peterson |
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Mr. Rob Merrifield |
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Dr. Robert Peterson |
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Mr. Rob Merrifield |
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The Chair |
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Mr. Réal Ménard |
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Dr. Robert Peterson |
| À | 1005 |
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Mr. Réal Ménard |
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Dr. Robert Peterson |
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Mr. Réal Ménard |
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Dr. Robert Peterson |
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Mr. Réal Ménard |
| À | 1010 |
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Dr. Robert Peterson |
|
The Chair |
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Ms. Hélène Scherrer |
|
The Chair |
CANADA
Standing Committee on Health |
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l |
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l |
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EVIDENCE
Tuesday, September 16, 2003
[Recorded by Electronic Apparatus]
¿ 
(0905)
[English]
The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Good morning, ladies and gentlemen. I'm pleased to welcome you to this meeting of the Standing Committee on Health. This essentially is our first meeting on our new study subject, the study of prescription drugs.
Our first witness, from the Department of Health, is Mr. Robert Peterson of the Health Products and Food Branch.
Mr. Peterson.
Dr. Robert Peterson (Director General, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health): Thank you, Madam Chairman, and members of the committee. I appreciate the opportunity to address the committee this morning.
I will be focusing my remarks on two elements within the scope of your study on prescription drugs--namely, the process by which Health Canada reviews drug submissions and the access to drugs that is provided within the mandate of the Health Products and Food Branch. I will also take the liberty to provide you with information on initiatives that are currently underway to improve the federal review process for human drugs.
I believe a slide deck has been distributed in advance. I will make reference to slides within that deck during the presentation.
In slide two you'll see first the mandate under the Food and Drugs Act. The Health Products and Food Branch is mandated to review the safety, quality, and efficacy of new therapeutic products before they are sold to the public. It is also mandated to review the uses for already approved drugs and to monitor the safety and effectiveness of products that reach the Canadian market. As a result, and as I will detail in my presentation, all drugs sold in Canada must have what is referred to as “market authorization” from Health Canada. Market authorization is granted to a product if the product has successfully gone through the review process to assess its safety, efficacy, and quality.
As depicted in slide three of your document, the review process can be thought of as a continuum, incorporating pre- and post-market review functions. The pre-market review functions include preclinical studies, clinical trials, product submissions, product review, and the regulatory decision that is ultimately taken by Health Canada. Post-market regulatory functions include both the surveillance of products on the market and inspection activities.
In the black-and-white printouts you have, I believe there may be some difficulty in looking at blocks of print on subsequent slides. However, it is in slide three that we're simply taking the opportunity to highlight various sections in the subsequent slides.
In slide four, the pre-market review process involves the comprehensive assessment of studies, done by the sponsor of that drug, that take place in both animals and humans. Health Canada's first involvement in such assessments occurs at the clinical trial phase, and it continues through the authorization and decision stage.
A company must provide evidence to Health Canada of safety, efficacy, and quality of their therapeutic product. This evidence is reviewed by regulatory scientists. The review purpose is to ensure that the evidence supports the therapeutic claims, the specific claims that are being made, and to ensure that the health benefits of that product do in fact outweigh its potential risks. If this is found to be the case, the therapeutic product is granted market authorization and may be made available for sale in Canada.
In the interest of time, I will focus on specific activities within the pre-market review process. Those are the activities that I anticipate may be of interest to you.
First, clinical trials. In September 2001, a new regulatory framework for clinical trials was implemented in Canada. This framework introduced a 30-day default period for all clinical trial applications that are submitted to Health Canada. In addition, for certain phase one and bio-equivalency trials, an administrative performance target of seven days was established. Health Canada has continuously met and often exceeded both of these performance targets. The current clinical trials' regulatory regime enhances safety for clinical trial participants and competitiveness of the research environment, and thus growth of the Canadian research environment.
As seen in the next slide, during the product review stage Health Canada regulatory scientists examine safety, efficacy, and quality data in some detail to assess the potential benefits and risks of the product. This entails a comprehensive review of all animal pharmacology and toxicology studies; human, clinical, and safety studies; and chemistry and manufacturing information.
As depicted in slide seven, just for your interest, a new drug submission can vary from 100 to 800 binders of information, each containing approximately 400 pages of information. Thus, a large submission, with the pages placed end to end, would create a path 83 kilometres long, along which our review staff must journey, at each stage reviewing the information on a given page.
¿ (0910)
In addition to the standard submission process, submissions may be granted a priority review status. This provides for an expedited review of new therapies--preventive or diagnostic agents that are designed for the treatment of serious, life-threatening, or severely debilitating diseases or conditions. These submissions are subjected to the same quality, safety, and efficacy requirements as non-priority submissions; however, Health Canada will assign additional resources to a submission that has achieved priority review status, in order to meet an expedited review target.
Upon completion of a review, as shown in the next slide, a Health Canada decision is rendered through the issuance of a market authorization in the form of a notice of compliance, along with a drug identification number. Alternatively, if the submission is deficient or incomplete in complying with the requirements set out in the Food and Drugs Act and regulations, a notice of deficiency or a notice of non-compliance is issued, as appropriate.
It's important to recognize that the responsibility of the pre-market review directorates continues through the entire product life cycle. While the Marketed Health Products Directorate and the Health Products and Food Branch Inspectorate have responsibility for specific post-market activities, close cooperation is maintained among all of the directorates in order to ensure that information is shared and appropriate action is taken.
My colleague from the Marketed Health Products Directorate will be appearing before you at a later date in order to provide you with greater detail about post-market assessment and surveillance activities.
On the Health Products and Food Branch Inspectorate, its primary role is to deliver a national compliance and enforcement program. This is accomplished through cooperation with other branches at Health Canada, with government institutions, as well as through industry inspection, product investigation, establishment licensing, and other related laboratory functions.
In addition to the market authorization provided to a product as a result of successful completion of this extensive review process, access to therapeutic products is available in Canada through two additional mechanisms, the first of which entails clinical trials. Patients may have access to experimental therapies through clinical trials prior to the drug's authorization for sale in the general market in Canada to a larger population.
In addition to a route through clinical trials, access through the special access program permits practitioners to request emergency access to therapeutic products that are not available in Canada for patients who have serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or are otherwise unavailable. The special access program is not intended to be a mechanism to circumvent the normal therapeutic review process, but rather is intended to provide compassionate access on a patient-by-patient basis.
As you may be aware, in the mid-1990s Health Canada established performance targets with respect to the review time to first decision for new submissions for human drugs. These targets are comparable with those set in the United States by the United States Food and Drug Administration, as well as other international competent regulatory authorities. To be candid, we have not been meeting our review time performance targets over the past decade. This is reflected in our review backlogs. Our current performance lags behind that of the United States Food and Drug Administration, and the European Agency for the Evaluation of Medicinal Products of the European Union, but it is on par with the Australian agency, and is ahead of the performance by the regulatory authority in Japan.
We have taken action to address our performance against the published performance targets for review times of these new drug submissions. For example, over the past four and one-half years, the average performance on priority submissions--those submissions that have the highest impact on health--is approximately six weeks, or 45 days over our performance target. I must say, however, that over the same time period the average performance on a standard submission is well over our expected target of 355 days. There is room for improvement, and we are committed to making substantial performance improvements.
¿ (0915)
Funding provided in budget 2003 will help us to improve regulatory performance, including timeliness of reviews, transparency, and the predictability of the review process itself, and we intend to do so while maintaining Health Canada's high standards for safety.
In keeping with the government's Speech from the Throne commitments for smart regulation, we are investing in key business practices associated with the review process to transform efficiency and effectiveness by adopting and adapting international best practices and standards where they make sense in the Canadian environment. To ensure that we not only improve our regulatory performance but sustain it as well, we've taken a comprehensive look at reviews of our past performance, both what we do well, such as our safety record, and where we need to improve. We have analyzed the keys to success for the world's top performing regulatory authorities in this area. I refer here to the United States Food and Drug Administration and the European Agency for the Evaluation of Medicinal Products. It's part of the European Union. Through this analysis we have identified success factors for regulatory performance and the specific best practices used by the top performers to achieve them. These include top-notch business processes, efficient use of external expertise, and other measures to improve transparency. As well, stable and adequate funding has been identified as a necessity and by all top performers as a key to their success.
We are, therefore, also investing in enhanced international regulatory cooperation and increased transparency. We are working closely with international partners, through the International Conference on Harmonization, on data standards, and we will support electronic submission and promote simultaneous filing of submissions in multiple jurisdictions.
I refer you to slide 14 in the area of post-market business improvements. My colleague from the Marketed Health Products Directorate will be appearing before you at a later date and will provide you with specific business line enhancements.
We're moving forward with inspectorate activities as well, to increase post-market inspections using a risk management approach, and we are increasing inspections to confirm compliance by manufacturers with our regulatory requirements.
We're committed to employing good business practices of transparency, communication, consultation, and performance reporting. As an example, we recently sought stakeholder input to our regulatory process and ways to improve its performance through consultations led by the Public Policy Forum.
In slide 16 I refer you to the approach we have adopted as a consequence of these internal discussions and our consultations. We are focusing on three key outcomes: safety, upon which Canadians have placed their greatest emphasis; a drug review process with predictable and internationally comparable review times; and last, transparency. This means not only transparency by Health Canada but also improved transparency by industry.
Madam Chair, we are listening to stakeholders and seeking to make substantive, sustainable improvements to our regulatory performance. We are committed to change, and that change should help Canadians have timely access to safe and effective drugs.
On that note, Madam Chair, I feel I should conclude my remarks to respect your time constraints, and I do look forward to your questions.
¿ (0920)
The Chair: Thank you very much.
We will move to questions, and the first questioner will be Mr. Merrifield.
Mr. Rob Merrifield (Yellowhead, Canadian Alliance): Thank you for coming in and starting this process off. It's really going to be interesting as we take a look at the agenda and all of the different (a) to (i) issues we're going to be dealing with in this thing and where it's all going to go. It's really quite broad, and I think that as a committee we're going to have to take a look at the parameters of where we're going with it. But I appreciate your coming in and giving us a launching pad.
You say that our timing lags behind the United States and it's comparable with Australia. It's not quite there. It's not satisfactory. What are the primary limiting factors behind the lag time?
Dr. Robert Peterson: At this point in time, we can break our processes down into largely resource issues.
The United States had the opportunity, in terms of the FDA, to expand greatly in 1992. Prior to that time period, our regulatory performance was basically comparable to the United States FDA. That organization had investments. In part, they came from their cost recovery initiative and from industry providing additional resources, and they were able to expand the size of their organization greatly. By comparison, the European Agency for the Evaluation of Medicinal Products came into existence with the European Union and the creation of a common table whereby many small regulators were drawn together to go through a confidence-building exercise to allow for them to leverage on the expertise of many small regulators in providing for the adequate review of applications.
We are comparable to other regulators our size, to small regulators throughout the world, in terms of our performance, but we do have difficulties in meeting the performance targets that have been established by these larger regulators that have substantially greater resources.
Mr. Rob Merrifield: So do we look at, say, some of the data in the United States, if they're a year and a half ahead of us, when reviewing our own, to be able to accelerate our own, or are we duplicating everything?
Dr. Robert Peterson: The ability to look at the information that is in the hands of the FDA is somewhat comparable to the ability that we would have to share the proprietary intellectual property that is contained within a submission, including a good deal of the deliberations that take place. That can exist under memoranda of understanding, mutual recognition agreements that take place.
However, because there can be substantial differences in the application that is submitted in one jurisdiction as compared to another, and because of, as you have pointed out, the timing of those submissions, either the time that they are filed or the time that we are able to pick up and begin review of the submission, as compared to the FDA, it causes the evaluation of that data to be somewhat different.
As an example, just under 3% of products that are approved in the United States, and this has been somewhat constant over the past 10 years, are withdrawn from the market in the early post-market phase because of the identification of substantial safety issues. That 3% figure sounds low at face value, but if we look at the resources that we put to the review of an application, the requirements that we have in place for the testing and evaluation, that's an unacceptably high number. In Canada that number for the same time period has been 1.6%.
I reference the fact that we are able to review portions of the post-market experience of that application from other jurisdictions as we go through the evaluation of the product. And there are safety considerations as well as other indications with regard to dosing alterations, etc., that may be identified in that early post-market phase. So there are differences in the review activities themselves.
We are looking, through the international cooperation initiative that we launched more than a year and a half ago, to build confidence and to identify those areas of the review process that are highly amenable to mutual cooperation. I can point out that within the slide material you have, those early pre-clinical studies that investigate the toxicity of the product in animals are very amenable to very strong international cooperation. It may also be the case that the chemistry in manufacturing assessments, provided that the product is sourced from the same manufacturing facility in the world, may also be highly amenable to that.
We reserve the fact that the Canadian health care system may differ sufficiently in the expectations of what the therapeutic product will do and what the risk aversion is within our regulatory environment as to looking very carefully at all of the clinical trial information and being able to take decisions with respect to market authorization, but continuing the expertise that's developed during that assessment period into the post-market area.
¿ (0925)
Mr. Rob Merrifield: You said the problem really is resources.
The Chair: Your five minutes is up.
Is Ms. Hinton ceding to you?
Mrs. Betty Hinton (Kamloops, Thompson and Highland Valleys, Canadian Alliance): I have one question, then I'll give the balance of the time back to Mr. Merrifield.
The Chair: Okay, go ahead.
Mrs. Betty Hinton: You just mentioned 3% versus 1% in terms of safety, I guess, is the best way to put it, or reliability. How many new drugs are introduced into Canada versus the U.S.? I'm looking for something to back up the difference in the percentages that you mentioned.
Dr. Robert Peterson: That is a very, very important question. The numbers I've quoted are just under 3%, and approximately 1.6% as the number in Canada.
On an annual basis, we approve the same new chemical entities, new active substances, the same number of new active substances in Canada as are approved in the United States. The peak recently for new active substances was in 1999, with approximately 30 to 35 new active substances. I believe the United States FDA in that year approved 33 new active substances, while Canada approved 32. More recently the output from industry has declined, and we are presently looking at approximately 20 new active substances.
I must add that the new active substances that were approved in 1999 by the United States FDA were likely to have been approved in 2000 or 2001 by Health Canada, because there has been an offset, both with respect to our backlog and submission dates, taking place.
Mrs. Betty Hinton: Thank you.
The Chair: Mr. Merrifield.
Mr. Rob Merrifield: I'm going to go off on another line, because when I look at your mandate, you're saying your regulations are really there for safety, efficacy, and quality, and I assume that every product is assessed under exactly the same criteria. But when I look at what you're doing with medical marijuana and I read the papers this morning, I wonder if it meets the safety, the efficacy, or the quality, any one of these. Can you explain to me why it hasn't jumped through the same hoops?
Dr. Robert Peterson: What I can report to you is that we have not received an application for market authorization for any products containing medical marijuana under the current production facilities. There is a product licence in Canada that contains the active component of marijuana, tetrahydrocannabinol, that has been subjected to exactly the same rigorous criteria and has achieved market authorization.
¿ (0930)
Mr. Rob Merrifield: Is it the same as the medical marijuana? Does it have the same product as the marijuana that's grown under licence?
Dr. Robert Peterson: Again, I will attempt to define a difference between an active medicinal ingredient and a product.
We review and assess each individual product irrespective of whether it may contain an active medicinal ingredient that we have seen in previous products or not. So the product that has been approved on the Canadian market contains the active cannabinoid that is present in the marijuana plant itself. We have subjected one application that contains that medicinal ingredient to this review process and it was successful in reaching market authorization. That review was equivalent to any other therapeutic product that we would bring through our review process.
We have not received an application for marijuana as a product itself, to bring that through the process. Should that happen, one of the active medicinal ingredients in that preparation, whether this be a portion of the plant and so on, would be a cannabinoid, but because we look at the product itself we begin to ask questions as to what else would be present in that submission.
We have not received an application. Should we receive an application, it would be subjected to identical criteria.
Mr. Rob Merrifield: So you're saying the licensing of medical marijuana is not being reviewed at all, as it were?
Dr. Robert Peterson: At this point in time, we have not received an application, a submission, for a product to be brought through our regulatory review process.
Mr. Rob Merrifield: That's really interesting, especially when you say tetrahydrocannabinol, which you're telling me is the same product, is licensed.
Dr. Robert Peterson: There is a product that contains that as the active medicinal ingredient; that's correct. It is a specific dosage form.
Again, I think it's important to recognize, just because one product containing an active medicinal ingredient has been reviewed in the past, that does not provide any difference to the rigorous assessment that would be applied to any subsequent product, even if it contains the same medicinal ingredient. The exception to that would be in the entry of a generic product. Then the rules around the generic product entry through an abbreviated new drug submission is that it must contain identical quantities of the identical medicinal ingredient, and then we will accept the safety and efficacy studies of the original submission and simply require the generic manufacturer to provide evidence that their product will be equivalent to the established product when it is taken in the same dosage form. That's typically done by comparison of blood levels.
The Chair: Thank you, Mr. Merrifield.
Mr. Ménard.
[Translation]
Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ): Thank you, Madam Chair.
I have five questions which I'm going to ask sequentially, and you can then reply to all of them. Is “active ingredient” synonymous with “medication”?
Secondly, you know that what led to the adoption of the committee's motion is that indications are that the cost of medication is increasing by 20% per year. Obviously, you can't explain that, but I would like you to tell us where the grant of a patent fits in in the process you explained. When an investigational drug is submitted to you, does the pharmaceutical company have the patent for it, and when does it obtain it?
Thirdly, I would like you to tell us about the links between your branch and the Patented Medicine Prices Review Board. When one reads the annual report of the Patented Medicine Prices Review Board, medication is listed in three broad categories, and if one looks at the tables from the past five or six years, one sees—and this will be studied by this committee—that there are a lot of new medications, submitted to you as investigational drugs, about which it is said that the curative value, the new therapeutic value, is not really new and that this increases the cost of medication. There are medications authorized for sale by you that have few new therapeutic effects. What information can you give us in this regard?
Fourthly, and I will stop here, we were told that companies that filed clinical monographs with you had to pay for most of the costs. What is your cost recovery policy?
¿ (0935)
[English]
Dr. Robert Peterson: I counted only four questions, rather than five.
Mr. Réal Ménard: I'll be back.
Dr. Robert Peterson: The active medicinal ingredient--and there may be more than one, by the way, within a product--provides the therapeutic effect of the product. There may be other substances present in the product that can allow for it to stay in solution if it is a liquid, that bind it together if it is in a tablet. The capsule and the material that makes up the capsule, which may be gelatin from animals, in typical instances from cows, are all non-medicinal, non-active ingredients within the product. We require disclosure, for human prescription medications, of all that material, and we review the quality of any of the materials that are present for safety of the product itself and for efficacy. The efficacy is caused by the active medicinal ingredient, but may be modified by the way in which the product is formulated--the tablet dissolves readily, the product is delivered over a sustained period of time after it has been swallowed, rather than just a short period of time. That would be the background on the reference to the active medicinal ingredient portion of it.
I am not certain how much I can provide testimony for with regard to cost, since we do not establish prices, nor do we have any role in assessing what the cost of a product would be.
We do have responsibility for the notice of compliance patent regulations that are passed and maintained by Industry Canada, and those notice of compliance patent linkage regulations, which Health Canada has responsibility for administering, do have certain requirements. The specific requirements with respect to patents say that a company, in order to achieve protection for its product in Canada, must submit its patent application prior to submitting the new drug application to us. That is required within regulation, and there are undoubtedly reasons why that level of intellectual property protection is established in that fashion. We do not--
[Translation]
Mr. Réal Ménard: Excuse me, I want to make sure I understand correctly. This means that when we are told that certain pharmaceutical companies do not have 20-year protection for their patents, that is not possible, because the patent becomes effective as soon as you have authorized an investigational drug. There can't be a patent if there is no investigational drug number and if a drug has not been authorized. That is what I do not understand in what you have said.
[English]
Dr. Robert Peterson: This is a very complicated area, and perhaps I am not your best expert on this, but allow me to go through the various levels. First, the patent is applied for through the Canadian Intellectual Property Office well before we ever see the application. So a patent typically is assigned before this product is brought into clinical trials, and the first time within the drug development process Health Canada becomes involved with the product is at the human clinical trial phase. Prior to that, all the work that may be done in animals, etc., is done under the authorship of the sponsor itself. Under most circumstances, patents are achieved to protect that particular chemical entity well in advance of moving it through this development scheme. So the only requirement of the notice of compliant patent linkage regulations is that for a patent to be listed on the patent register in Canada, the patent must be applied for prior to the submission of the application to Health Canada. That's different from the authority we grant. A drug identification number is a number that goes onto a product that allows it to be uniquely identified as it is marketed in Canada and allows for us to track back through our entire approval system and to validate that the product has been granted market authorization in Canada. So the drug identification number, the market authorization, takes place at the conclusion of our review process, but it is independent of protection that is achieved under patents.
¿ (0940)
The Chair: Mr. Peterson, we'll have to hear the rest of your answers later. Mr. Ménard's time allocation is up.
We'll go to Madame Scherrer.
[Translation]
Ms. Hélène Scherrer (Louis-Hébert, Lib.): Thank you very much, Madam Chair.
Mr. Peterson, I have two questions. A measure had been announced in the Speech from the Throne which was that $190 million would be granted to Health Canada in order to reduce the time needed for access or for the marketing or recognition of certain products. I would like to know if that $190 million was allocated. Was there concrete action? What were those actions? What is the timeframe for that action?
I have one question left, and I will ask it after you reply.
[English]
Dr. Robert Peterson: Budget 2003 identified $190 million over a five-year period to provide for increased funding in support of the specific objective to speed up the regulatory process for drug authorizations. We are beginning to see some of those dollars in our budget this year. We have, through the business processes I outlined in very general terms to you this morning, been very cautious to maintain separate accountability for those new dollars that are coming into the system specifically identified for the purpose of speeding up the regulatory process. We have established an office of business transformation in the directorate that I have responsibility for in order to introduce new business processes. So we will not put new dollars into old business practices, but will use this opportunity to transform our operation into one that is taking advantage of best practices we have learned in other regulatory environments.
Ms. Hélène Scherrer: Such as?
Dr. Robert Peterson: One of the principal initiatives happens to be regulatory project management. If we look at the successes of the United States FDA--and we've had very candid discussions with them--clearly, the increased resources they achieved through their external charging capacity was very important to them. However, if you ask them, in addition to the resources, what has allowed them to transform their organization, the answer is allowing for a specific management process to take place. When a submission comes to us at the present time, that is the first we know of the application. So we are moving tremendously upstream in that process to sit with companies and ask them, what will your application, when it comes to us, consist of? What will be the claims? What is it in general that you're looking for? And we will work with them in order to negotiate exactly what will be required in order to move that application through our regulatory environment with a great deal of optimization.
Second, once we receive the application, we will look at when it will be due to come out on performance target, and we've been able to track backwards now and establish milestones in that review process to allow for us to identify whether there is some delay within the process that has been unexpected, and if there is, what is the cause of the delay. And we've provided management opportunities to use options to bring that application through other pathways in our system in order to achieve success.
To the extent that we have done that, we've worked closely with the United States FDA. We have sent our project managers, a new group of individuals, to the FDA to spend time with their regulatory project team, we have had video conferences with them, we have invited them to Canada. This is one of their key success factors, and as we can put that into the Canadian regulatory environment, we will do so.
[Translation]
Ms. Hélène Scherrer: May I ask a second question?
[English]
The Chair: One minute.
¿ (0945)
[Translation]
Ms. Hélène Scherrer: As a consumer, I note that what we see very often on television are American pharmaceutical products that are not currently available on the Canadian market. I know that in Canada publicity is prohibited for Canadian medications, but I would like to hear your comments about the fact that the Canadian population is subjected to publicity for American products and does not have access to Canadian products, and about the fact that the products we see in magazines or on television are products that are not available.
Are you going to act in this regard? Will the prohibition be maintained, or can something be done about this?
[English]
Dr. Robert Peterson: Access to products for the Canadian consumer is a very complicated issue. My responsibility for the approval of submissions made to us is one very important portion of that. I cannot comment, ultimately, on whether the product will be brought to market by the Canadian manufacturer. Even if we have been through the approval process and have granted market authorization or not, there are corporate decisions taken with respect to which markets a product will be brought to early and which late. I would venture to say that most of the objective within the pharmaceutical industry today is to bring new products to the United States market. So when we see advertising that comes across through our networking for United States products, it may, in part, be because we have not seen the application, or if we have seen the application, it has not yet been approved, but is in the process, or there is no specific objective to bring the product to Canada.
I would also caution, however, from the limited contact I have had in looking at similar ads, that there are differences in names of products in the United States. While the name of the product may not be recognizable within the Canadian context, in fact, the equivalent product is available.
The Chair: Thank you, Dr. Peterson.
Thank you, Ms. Scherrer.
Ms. Bennett.
Ms. Carolyn Bennett (St. Paul's, Lib.): Thanks, Madam Chair.
I apologize, Dr. Peterson, for being late.
Just to follow up on the FDA, I understand the FDA has a system where if the drug has wide approval in other places in the world, there's a stakeholder group.... I know you've worked with Best Medicines Coalition, or the Office of Consumer and Public Involvement has, and together with this stakeholder group they actually green-light a drug without putting it through the regular channels based on risk assessment and risk management.
I guess this is my question: do we need to do all of this again in Canada if the cancer groups really have studied this in terms of international evidence, or the AIDS groups have, or all of that? Is there not some risk management we could do that wouldn't mean we had to go through the whole thing? If there was any question about who funded the study or the size of the sample or any of those things, we would put it through the regular channels.
As a second part to this question, couldn't we then in Canada, with our single-payer system, be focusing on post-market drug surveillance in the best way in the world and use Robyn Tamblyn's system of BlackBerry prescribing or some way where we could actually be way ahead and have something in the world? I guess what I want to know is this: how far along are we in terms of playing red light, green light with spectacular international evidence that's already at our fingertips?
Because Madam Chair's so strict, I'll ask my next question. You may not be able to answer it. What would be the impediment to having a separate drug agency without the encumbrance of a big ministry for your department—a serious drug agency that the provinces bought into and that we could actually go forward on?
Dr. Robert Peterson: Thank you, Dr. Bennett, for those questions.
I'll begin by answering the impression of the FDA. The United States FDA does not rely upon any other regulatory authority for their decisions. In fact, they are perhaps the most closed of all of the regulatory authorities in the area. So while there are some substantial differences within the review process that they have available to them under their rules as compared to our regulations, they do have the opportunity for certain public advisory meetings for some applications, and a great deal of information is shared at those public meetings with respect to what may have taken place elsewhere.
We have scientific advisory committees and we have groups that have incorporated patient advocates and representatives from the public in many expert advisory committees that we have had. But we do not have the same type of public meeting whereby you can read transcripts of these proceedings, whereby information shared from what has taken place in other jurisdictions in the world can be made known. In fact, that is not the basis for which the FDA's mandate allows for the approval of drugs; they must review the application themselves.
¿ (0950)
Ms. Carolyn Bennett: Are there other countries, then, that do that? Isn't there a harmonization group happening in Japan where people are asking why we are all doing this?
Dr. Robert Peterson: Yes. The International Conference on Harmonization has been developed, and the three principal jurisdictions are the United States, Europe, and Japan, representing perhaps 85% of the world's market for pharmaceuticals. Canada is the only individual country outside those regions that has been invited to sit at that table as an observer, and I can tell you that we have been very active in our observer status. We have held the pen on a number of the guidance documents that are now coming out.
We have adopted those guidance documents, but they are guidance documents. These are road maps for industry and agreements among the regulators that this is the minimum evidence that would have to be supplied in order for an application to be successful coming through the individual regulators. But each of the individual regulators has preserved their own decision-making process.
The exception to that is the European Union's EMEA, the European medicines evaluation agency, which was brought together at the same table to allow for confidence-building and mutual recognition. A very small percentage of the applications in Europe today go through a central process whereby it is the EMEA that takes the decision and then countries who are members of that economic union will accept those decisions. But there are open decisions taken in consultation with all of the competent regulatory authorities that sit at that table. Their performance targets are very comparable to ours in terms of what is published, because they can leverage the expertise amongst the various regulators. Then they have a higher capacity to move applications through the system.
There are examples of countries that have simply adopted what other regulators have done. Hong Kong is a good example of that. Hong Kong will accept decisions that have been taken by the FDA and by the European medicines evaluation agency. I can also tell you that as of a bit more than a year ago Hong Kong has taken the decision that Canada's competent regulatory authority's decisions are sufficient to allow for them to approve the drug as well.
I think that on the issue regarding the focus on post-market there is going to be another witness appearing, talking about post-market activity, so I hesitate to take our time to do that.
On the issue regarding a separate drug agency, I believe many models throughout the world have been successful in the way the drug regulatory authority has a relationship with their government. Many of those models are highly successful and, I believe, could be the basis for issue analysis around what would be right for Canada.
The Chair: Thank you, Dr. Bennett.
Dr. Castonguay.
[Translation]
Mr. Jeannot Castonguay (Madawaska—Restigouche, Lib.): Thank you, Madam Chair.
I have three questions. The first has to do with the special access program. Has the number of drugs that require special access increased in the past few years?
Insofar as priority reviews are concerned, how do you determine that a drug will be the subject of a priority review rather than a standard review?
Finally, are priority reviews done at the expense of standard reviews, with regard to available resources?
[English]
Dr. Robert Peterson: We have seen a steady increase in all parts of our workload over the past three years, the special access program included. Issues such as the recent outbreak of SARS can drive the work of the special access program insofar as we were responsible for the approval and the release of several therapeutic agents that were otherwise not available on the Canadian market in order to allow patients in Toronto and potentially in Vancouver to have access to those drugs. We have seen recent events have a major impact upon the workload of that organization.
Meanwhile, there is a relatively steady rate of requests for applications for products that are not approved in Canada for what would be considered orphan diseases; in other words, products that have not been brought through the Canadian regulatory process because the commercialization of those products in Canada has not been considered to be viable. Those are products that may in fact be the basis of the original intent of the special access program, namely the compassionate release of those products or the emergency release of a new product that may have been brought through a regulatory process elsewhere in the world, but that either is pending or has not been brought through Canada.
I think it's important to note for you that the special access program must take on the responsibility when products are withdrawn from the Canadian market. A company may take a marketing decision that a product is no longer commercially viable in this market and remove the product from the open Canadian market, which means that it is our special access program that must seek a source of that product from another market in another portion of the world. There have been many examples of that, unfortunately, in the past three years. We've had discussions with industry about what the appropriate steps might be to withdraw a product from the Canadian market in order to allow for the subsequent accessibility of that product.
Priority review applications are made specifically by the sponsor, who will provide to us in no more than 10 written pages a succinct summary of why their product will have a high impact upon a health need that has been unmet at this point in time. That is typically for a very serious or life-threatening illness, and the majority of the applications we have seen come through have been in that format. Not surprisingly, over the past four or five years many of the products that are destined for treatment of HIV infections or AIDS have been able to achieve priority status. It is typically the first product in a class that can provide this brilliant new therapeutic opportunity that we will allow to be qualified under those circumstances.
So we review that application. If the application is granted priority status, then our performance target is 180 days for that application. This is the same performance as that of the United States FDA. I must point out to you that in the past 12 months we have outperformed the FDA's reporting with respect to priority applications. Only approximately 10% of those applications that come through the pharmaceutical path can achieve priority status. The rest are products that already exist in one guise or another on the Canadian market.
However, we are at the present time approximately 45 days over our average performance time for the first decision on priority review applications. In full honesty, I must tell you the way we achieve this is that we do shift resources into that area. These are the applications that we believe have the highest impact on the health care system. We have reviewed them for that particular purpose, and we move resources into that area in order to be certain they come through.
Your last question was on resources overall?
¿ (0955)
[Translation]
Mr. Jeannot Castonguay: So far, your answer leads me to believe that if you use your resources to do priority reviews, they are no longer available for standard reviews.
[English]
You have just so many resources, and you take from the standard reviews to do the priority reviews. Is my understanding correct?
Dr. Robert Peterson: Yes, you're correct. The direct answer to your question is yes.
Mr. Jeannot Castonguay: Thank you.
The Chair: Do people want another round?
Mr. Rob Merrifield: Actually, I did have some specific questions on post-market surveillance, but if you have another witness coming in, I'll save those for a future witness--unless you would like to take one.
Dr. Robert Peterson: I believe my colleague will be in a very fine position to answer your questions.
Mr. Rob Merrifield: Okay, let's leave that one.
Quickly, before we leave this issue, you said that the limiting factor to meeting the same timelines as the United States, as far as getting approvals goes, is resources. What percentage of increase in resources would it take to meet their timelines?
À (1000)
Dr. Robert Peterson: That's a question we have asked ourselves on many occasions. We believe that the opportunity to leverage decisions, in portions of the review that have taken place in other jurisdictions, will have a major impact upon that. And as we are presently moving through discussions with other regulators as to what we may leverage in terms of materials that have been looked at there, we are not in a position to determine exactly what the efficiencies are that will be gained through that route. Until we have been successful in getting access to those materials, it's not going to be possible to answer your question precisely.
We do believe that the resources that have been made available in budget 2003 and the manner in which we are intending to use them will have a substantial impact upon the review activities. We are directing the early phases of our new resources to clearing out our backlog that has developed over the past four to six years and has caused us to not meet performance targets, because an application may sit four to six months before our review teams even pick it up.
In the recent past, when we had contracted with an external company in order to do an assessment of our review processes, what was determined was that when our review teams pick up the application and begin the review, we can meet that review within the performance time period that is internationally acceptable. The time over performance, on average, is the time the application must wait in queue for us to be able to pick it up. That's why I can refer back to a capacity issue or a resource issue.
With the new resources, as we clear out our backlog, then our teams will be able to pick up the application as it comes in to us. Furthermore, as we move upstream in our discussions with companies in order to be able to predict what applications will be coming to us over the next one-year review cycle, we will be able to take appropriate action to have the appropriate review teams, both internal as well as external scientific expertise, available at the time that the application comes in and be able to pick it up at that appropriate time.
Mr. Rob Merrifield: What is your timeline on getting rid of the backlog?
Dr. Robert Peterson: We would like to have at least 90% of that backlog eliminated within the first 24 months of our new funding.
Mr. Rob Merrifield: Okay.
The Chair: Mr. Ménard.
[Translation]
Mr. Réal Ménard: Let's get back to the topic of our study : the cost of medication. The Patented Medicine Prices Review Board created by Mr. Mulroney's Conservatives through Bill C-71 lists drugs in three categories. When you grant an investigational drug permit which will lead to the marketing of a product in Canada, does the therapeutic value of a new medication constitute a basic criterion, or are we faced again with a situation like last year's, when you authorized 90 drugs, according to the Patented Medicine Prices Review Board—not active ingredients, but generic and patented drugs—and where it is being said that only 10% of these drugs are really new drugs? In other words, can you grant investigational drug permits and marketing authorizations if you know that a drug has virtually no new therapeutic value? Is it true that this can happen with today's procedures?
[English]
Dr. Robert Peterson: We do have the priority review drugs that I have attempted to define for you as the very new therapeutic opportunities that will exist within the health care system, and we put resources to those. There are other products for which there may already be a product in existence. There are many products on the Canadian market that will reduce blood pressure, and there are many products that will reduce the amount of cholesterol in your blood stream, as examples. However, there are no products on the Canadian market that will cure AIDS specifically. They will prolong life; they will reduce viral load. Should a new product come along that can specifically provide that claim, then that would be given a priority review status.
Another example is that there are no products that would cure SARS. If a product were brought to our attention that would do so, it would be the first and it would be granted priority review status.
Now, to distinguish that, we may see an application come to us today whose specific claim is that it will lower blood cholesterol, and it may belong to the same class, although it has a different medicinal ingredient and is a different product from those that are already on the market. We would look upon that as a standard application.
À (1005)
[Translation]
Mr. Réal Ménard: Excuse me, that was not my question.
The Patented Medicine Prices Review Board puts drugs into three categories: A, B or C. What I want to know is whether when you grant a marketing authorization and when a product is authorized for sale either over the counter or with a prescription in Canada, the sales authorization takes into account the innovative character of the medication? Is it true that Health Canada grants sales authorizations and that only 10% of the new drugs that are authorized in Canada are innovative? I know that there is no drug for AIDS specifically, but answer my question on the innovative character of drugs.
[English]
Dr. Robert Peterson: Again, I'll refer back. Some biotech applications may be as high as one-third of the new products that have specific new benefits that can be identified with them. Of those products, 10% will achieve priority review status, and we bring them through the application phase that way. I can tell you that for a generic drug, which is an old-established drug that is outside of patent protection at the present time, we also attempt to approve those drugs within the same timeframe as a priority drug. Our review performance target for a generic drug, or an old drug that is being genericized, is 180 days as well. The basis for that is the belief that the economic benefit that may be derived by the health care system for a lower-priced product may be important, and therefore we basically provide resources to approve those drugs in a similar timeframe as the priority review applications.
[Translation]
Mr. Réal Ménard: Perhaps I was unclear. You are on the defensive on the matter of time periods. A subcommittee already studied that matter. Since 1995, I have been told that this will be brought down to 300 days. In my opinion, the criterion is not necessarily the length of the time periods involved. Pharmaceutical companies are the ones that are bringing pressure to bear in this regard; it is not the committee's work.
What I want to understand is that according to what we are told, the cost of medication increases in the two years following its introduction on the market. The Kirby Commission studied that, as did the Senate. We are told that Health Canada authorizes medications for sale in Canada that are basically not new medications. In the review carried out by your researchers—I don't know if there are 30, 40 or 45—what importance do you give to the innovative aspect of the investigational drug you are going to authorize? Is this of paramount importance, secondary importance, or does it have no importance, and does it matter whether a priority review is involved or a standard review? That is what I'm trying to understand.
[English]
Dr. Robert Peterson: Again, the drugs that come through as priority review have clearly established new benefits and they are for very important areas of disease or conditions. We do have a very large number of what we refer to as supplemental new drug submissions. These are drugs that are on the Canadian market for other purposes, for which a new therapeutic indication has been identified through clinical trials, through studies. There are, on a daily basis, those applications that are coming through to us, so a drug that has been approved in the past for issues associated with sleep disorders may in fact have its indication extended because a clinical trial has demonstrated that it is highly effective in the treatment of a panic disorder, for example.
[Translation]
Mr. Réal Ménard: I will conclude on this. I must leave because as you know there is a debate going on on marriage which we hope to win. Could you table a standard file with the committee including the forms that you ask pharmaceutical companies to fill out so that we may have a look at them, as parliamentarians? Could you also draw up a list of the medications among those that have been approved in the past five years which have some innovative characteristic according to you and which were processed as a priority? If you could send us such a file so that we know what documents the pharmaceutical companies have to fill out, as well as the list of the medications approved during the past five years that have some innovative therapeutic value, we would appreciate it.
I do apologize, Madam Chair, but I have to make a speech in the House.
À (1010)
[English]
Dr. Robert Peterson: Yes, very fine. And I'd be more than willing to make that commitment.
The Chair: Thank you, Mr. Peterson.
As our opposition members are leaving, we are losing our quorum for hearing witnesses, which automatically brings the meeting to a close due to the rules.
Before we dismiss, we seem to have quite a crowd for our first meeting, and I'm wondering if I could ask for the audience's cooperation. Could you raise your hand if you're with our federal Department of Health? There are thirteen. Could you raise your hand if you're with a pharmaceutical company? Three. And could you raise your hand if you're a student? Three. And there is one reporter.
Thank you very much for your attention.
This portion of the meeting is over, and for the members who are left, we really can't proceed. I don't have very exciting news about the trip, or anything that can't wait until Thursday morning.
Ms. Hélène Scherrer: Are you hoping we'll have quorum at that time?
The Chair: Yes, I would think so. This is a major day in the House for a lot of people, so that's why they're not here.
This meeting is now adjourned.