:
I call this meeting to order.
We haven't done this at committee before, but we've asked the veterinary drugs directorate to come before us. It is similar to what we do with PMRA, bringing it in as a Health Canada representative, but with regulatory power over the agriculture industry.
Many of us around the table who represent rural ridings and some of us who are livestock producers are always interested in what's happening in the approval process of animal health products as well as the whole issue of price parity and competitiveness with the international markets we deal with, including the United States.
We want to welcome to the table Dr. Siddika Mithani, who's joined us as the associate assistant deputy minister of the health products and food branch, and Bob Hills, who is the manager of transmissible spongiform encephalopathy at the veterinary drugs directorate of the health products and food branch at Health Canada.
I welcome both of you. I understand you're going to make an opening comment. I remind you to keep it under ten minutes.
:
Good morning, everyone.
I want to thank the committee for inviting Health Canada to discuss the approval process for veterinary drugs.
I would also like to take this opportunity to introduce Bob Hills, who is accompanying me here today. Mr. Hills is a manager in the veterinary drugs directorate at Health Canada.
[Translation]
I want to begin by emphasizing the important role that Health Canada plays in protecting human and animal health and ensuring the safety of Canada's food supply.
[English]
This activity contributes to the Government of Canada's overall food and consumer safety action plan, which seeks to modernize our regulatory approaches by focusing on active prevention by providing better safety information to consumers and guidance to industry; establishing effective deterrents; providing targeted oversight by requiring safety tests and information about products in the marketplace so that oversight can be focused on products that provide the greater potential risk to the public; and providing rapid response in order to allow the government to take fast action when a problem occurs, including the ability to recall products.
In the context of this overall action plan, Health Canada evaluates and monitors quality, safety, and efficacy of veterinary drugs. The department also promotes the prudent use of veterinary drugs administered to food-producing animals as well as companion animals.
[Translation]
For a drug to be marketed in Canada, a manufacturer must submit data to substantiate the safety, efficacy and quality of their product under the proposed conditions of use. A new drug submission that is filed by a manufacturer must satisfy all the requirements under the Food and Drugs Act and Regulations. These are administered by Health Canada.
[English]
A new drug submission must contain the following information: chemistry and manufacturing information about the drug product, pharmacology and toxicology studies, clinical animal studies, and tissue residue studies if the drug is intended to be used in food-producing animals. A new veterinary drug is approved for sale in Canada only if Health Canada is satisfied the drug is safe for the animals being treated, is effective for the purpose for which it is being marketed, and does not leave potentially harmful residues that could pose undue risks to humans eating food products from treated animals.
Health Canada plays a critical role in establishing maximum residue limits together with an appropriate withdrawal period to ensure that the levels of residues can safely be ingested daily over a lifetime and will not pose undue risks to human health.
I need to highlight that the department has taken several steps to develop efficiencies and improve the timeliness of the regulatory approval process.
[Translation]
A new drug submission tracking system has recently been introduced to better coordinate the regulatory process for drug evaluation. This system enables manufacturers to monitor the status of their drug submissions throughout the review process.
Health Canada continues to work with industry to develop processes and guidance documents to help them in filing complete and high-quality submissions.
[English]
The department also continues to encourage pre-submission meetings in order to inform industry of Health Canada's drug submission expectations. I am pleased to inform the committee that Health Canada is anticipating the elimination of the backlog for veterinary drugs by early 2009.
It is important for the committee to know that Health Canada is working with its international partners in sharing of information on approval and post-market surveillance of veterinary drugs. Health Canada continues to participate in international committees such as the VICH, which is the international cooperation on harmonization of technical requirements for registration of veterinary products, and Codex Alimentarius, in order to move forward on international harmonization issues.
[Translation]
Health Canada, together with the Canadian Food Inspection Agency, has recently established an external advisory committee that will assist in improving efficiency, capacity, responsiveness, cost-effectiveness and timely availability of veterinary health products.
Health Canada is aware of the desire from livestock producers to increase regulatory cooperation. The department is working toward increasing its efforts in developing standards and regulatory requirements with international bodies.
[English]
In conclusion, Health Canada is committed to ensuring timely access to safe and effective veterinary drugs, to working internationally to develop standards for veterinary drugs, to continuing to work with its stakeholders to improve efficiencies and provide clear and transparent guidance, and to ensuring the continued protection of the health and safety of Canadians and their food supply.
We will be pleased to answer any questions you may have.
:
Thank you very much for appearing this morning.
Similarly to the PMRA, we from time to time want to meet with you to set stakes to see whether there has been measurable progress made in terms of our movement towards harmonization. I know that isn't the word we generally use, but those of us around this table like to think we need to harmonize the kinds of things we do with our American counterparts because we work so very closely with them in terms of our exports and our imports.
Given that you're Health Canada, where you're dealing with human health issues, and now this morning we're talking about human health and we're talking about animal health as well, how do you reconcile between Agriculture Canada and Health Canada? Is there an issue between the two departments, the two ministries, in terms of finding common ground? I realize you have your jurisdiction, but is there an overlap here sometimes that can perhaps cause delay in the progress that could otherwise be made?
:
Thank you for your question.
With respect to veterinary drugs, the fact is that from a Health Canada perspective, our objective is the health and safety of humans and animals. There is some overlap in terms of Agriculture Canada. They also have a mandate to look at animal health, which is the reason we have the veterinary biologic products that are regulated by CFIA, versus the veterinary drugs being regulated by Health Canada.
When you look at the bottom line and the fact that we are looking at health, we recognize some of the concerns the Department of Agriculture may have, and it's really a partnership with them. We are able to look at how to balance the health and safety of animals as well as humans, which is of primary concern, and at some of the issues that arise from the livestock producer industry, from the Canadian animal health industry. The overarching objectives are very similar. There are some nuances and some specifics when you look at veterinary drugs and the interaction, but it's truly a partnership between Agriculture Canada, CFIA, and Health Canada. We have very similar objectives of looking at a real balance between health and safety, the protection of humans and animals, as well as not stifling innovation and being able to have a competitive market as we move forward.
:
An issue that comes to mind is a recent issue with our hog industry involving sickness that it was possible to mitigate with medication. How closely can we mirror what the Americans are allowed to use, given that meat flows back and forth and that we have a protocol whereby basically we accept here in Canada the standards that they deem safe for their people?
How do we mirror what they are allowed to use? In many cases, as PRMA would have us know, products are used in the States to produce product there that we buy into Canada, and yet we're not allowed to use those, in that case, pesticides.
In the case this morning, we're talking about animal medicine. There are medications that are used down there. How can we justify to the consuming public in Canada that the product bought from the U.S. in this case, and we'll stay with the U.S. for a moment, is safe for us to consume, when we can't use that medication here? How do you justify that to the producer of hogs, swine, cattle, or whatever, who is coming to you and saying, we want this product because we know it works, but it's not yet proven here in Canada? How do you make that justification? Rationalize that against the argument.
:
For a product to be approved in Canada, a manufacturing industry has to file a new drug submission. The issue that a drug is available in the U.S. and not available in Canada may be because the company has decided not to file the new drug submission here in Canada.
You know that in the past we've had a backlog of submissions, but we are at a stage right now wherein we are anticipating eliminating the backlog by 2009. So within the next year there will be a possibility for industry to be filing a new drug submission for approval in both countries at the same time.
The fact that we are lagging behind and do not have those types of drugs has been really a regulatory process issue up to now, but there have been process improvements put in place to make sure that in our market we create an environment that is conducive to competitiveness coming into Canada.
:
Thank you, Mr. Chairman.
First, I would like to welcome our witnesses, Ms. Mithani and Mr. Hills.
[English]
As we know, various agricultural sectors in the last number of years have gone through some very, very challenging times. Our government did a lot of consultations with various sectors to find out what was needed to try to put in place a long-term solution, something we could go forward with and to have something in place that would resolve these problems over the long term.
Some of the suggestions that various sectors of the industry brought forward were that if we were going to be competitive on the world stage—and of course we're living in a world market—we need to have innovative research and development. That was one of the solutions or criteria they suggested that we should have in our “Growing Forward” framework. They said that if we are going to remain sustainable, we must have leading-edge research and development.
How do you see it from a Health Canada perspective? How does the “Growing Forward” framework help you to address the agricultural sector's needs?
:
As you know, the “Growing Forward” national consultation document did propose targeted investments in the area of veterinary drugs to improve efficiency and to have predictability and reliability in the regulatory approval process.
It's a very interesting question you bring forward, because with some of the process improvements we have put in place and that we are beginning to talk about with the industry—there's a lot of dialogue with industry—the question is, how do you bring the initial studies into Canada so that we can have that research and development part that will allow Health Canada to get a lot more experience with a drug during drug development? Therefore, when you have a submission coming in for approval at the end of drug development, you will have experience, you will have experts who are aware of what's going on, and you will have veterinarians outside and inside Canada who have real experience with your product and know how to use it appropriately. The real balance between safety and efficacy is the appropriate use of these products.
So this is the dialogue we are having with industry. It is saying that we really need to bring in these products earlier on, at that stage, and to have that dialogue with them so that we are very clear about our expectations in terms of regulatory requirements. If we can tell industry very clearl that these are what the requirements are, they will not be going out for three years or five years doing studies that will not meet or fulfill the regulatory requirements of the regulator. That's what we are doing. So “Growing Forward” will provide us with some of the resources to be able to put those strategies into place as we move forward.
The goal, the real objective, of this initiative is really to be competitive. It's good public policy to have good drugs available. We recognize that livestock producers are here and that at this point in time they may not have access to good management health tools. The objective is really to be able to give them, or to create, an environment that is going to move us to that environment.
I think you mentioned the magic word—or which we like to think is the magic word—“dialogue”. You mentioned dialogue with the industry, and obviously you're mentioning dialogue with the pharmaceutical industry, but I'm assuming—and I better be correct here in this assumption—that you're dialoguing with the agricultural industry too. The whole idea is that everybody has to work on the same page here, because if we're not, obviously other countries are going to be eating our lunch on the world market and we won't remain competitive.
So are the producers, for example, part of the dialogue? Are they part of the solution?
:
So you can reassure this agriculture committee that the producer is at the table giving you input on the solution and the concerns. That is extremely comforting.
In your presentation you mention that in the overall action plan “Health Canada evaluates and monitors the safety, quality and efficacy of veterinary drugs. The Department also promotes the prudent use of veterinary drugs administered to food-producing animals”—which is something I'd like to take a second to clarify. You go on to say in another part of your talk: “A new veterinary drug is approved for sale in Canada only if Health Canada is satisfied that...it does not leave potentially harmful residues that could pose undue risks to humans eating food products from treated animals.” Then you say that “Health Canada plays a critical role in establishing maximum residue limits...”.
Can you explain how the consumer can be confident that, for the product they are eating, you have guaranteed that the maximum safe residues haven't been exceeded? You mentioned “prudent residues”. Can you explain that a little further?
:
I would imagine it's rBST that you're talking about. It's a drug approved in the U.S. It hasn't been approved in Canada. Obviously the concern when we looked at this particular drug was not human health but concern in terms of animal health. Therefore, the drug was not approved for use. The drug is also not approved for use in Europe and many other countries.
It's very important to remember that the door is always open for industry to come in with studies that will justify why the concerns Health Canada has raised can be alleviated. So as a drug company, if you were developing rBST or any other drug, you would file a submission. We would provide you with comments as to the reasons this particular product is not approvable and that additional studies would be required, or for you to be able to justify the rationale for that particular drug to be on the market.
Therefore, at this point in time, rBST is not a product that's approved for use in Canada because of animal health concerns, certainly not human health concerns. But there is no reason why, if the company had additional studies to justify our having a rethink, a re-examination of the information that's available, there wouldn't be an opportunity to reconsider any submission, not just rBST.
Lastly, the Animal Health Institute once again gives us reasons for some of the problems, and I'd like you to clarify this, because I don't understand it.
It's right here in front of me. They say, “Risk acceptance has declined within the VDD leading, in some cases, to risk aversion.” I don't understand what that means.
:
Again, I'm not here to interpret what CAHI is saying, but I think science has evolved. I think the processes that we have in the veterinary drugs directorate have also evolved.
I'd like to give you one example. In 20 years, we've never had the approval of a product at the first round where a manufacturer files a submission. It is always three or four years later that a letter goes out with deficiencies. This year, two drugs have been approved at the first cycle, so there has been a considerable improvement.
Some of the improvements are not in terms of looking at risk aversion and risk assessment but really being able to go out and get the expertise to help us in providing us with recommendations. One of the process improvements that we've implemented as we've moved forward is that when there are issues that are scientific in nature where there isn't the expertise within the veterinary drugs directorate, we've partnered with the CVMA, the Canadian Veterinary Medical Association, to identify experts in the field so that we can bring in a panel of expert advisers who will help us identify and address the issues that come in these submissions so that we can move forward.
I'm sure that's coming from the IFAH report, or part of it is coming from the IFAH report, but some of the processes we've put in place will help us move forward. Some of these strategies are really going to help us in bringing that balance between health and safety and being able to do those risk assessments. There's no sense in doing an assessment when you're not aware of what's happening practically in the outside world. So our interactions with CVMA, livestock producers, and industry are extremely important.
Thank you, folks, for coming.
On what we call the rBGH issue, I would say that if it weren't for this committee in 1995, that would have been allowed.
I will say this upfront, that we were not very impressed with Health Canada's position on allowing it for health reasons. It was stopped for animal health reasons at the end of the day, but I know both Paul and I reviewed a lot of that documentation at the time, in 1995, and I still have concerns over the health issues of that product. I do not believe that Canada should be allowing into this country products that are produced from cows injected with rBGH. I think it's a legitimate concern.
That moves me to my point, that one of the major concerns of producers, which we've heard increasingly over the last number of years, is that products are allowed to enter this country, whether from the United States, our major competitor, or from China—and increasingly from China—products that don't meet the same veterinary standards or health standards as Canadian producers are expected to meet. It's a serious problem.
We've suggested in a previous report that if a product is coming into Canada that doesn't meet the same standards as our producers had to meet, then that product shouldn't be allowed in. I think you're going to hear that increasingly loud from this committee.
If it isn't safe, if a product from our producers goes on grocery store shelves and they're not allowed to use a certain herbicide, pesticide, feed additive, or whatever drug because it's so-called “not safe” either for worker reasons or consumer reasons, then how the heck can a product using it end up on our grocery store shelves and drive our guys out of business?
Guy made the point on residue levels. That's one thing, but there's another side of the issue. There are certain products that farmers here are not allowed to use because of the human safety factors related to the people applying the product on the land. Our producers can't use that product because of the worker concern, yet the product ends up on the shelves. So how do we deal with that issue? Are we exporting our moral responsibility for workers? Are we saying they can breathe the spray dust but Canadians can't, and then we allow that cheap product onto our shelves?
:
But the issue here on these sound science conditions is that some Mexican labourer's health is at risk because they're allowed to apply a product—a pesticide, a herbicide, or whatever—on a crop. Our producers are not allowed to do that in this country because of concern for the health of the people applying the product, yet that Mexican product ends up on our shelves.
Now, is there a way of dealing with that one? I understand your concerns within Canada, but for our producers on the ground, producing.... It may be the cost of human lives in Mexico in terms of their labour, or wherever else, but our producers are being driven out of business because although that product doesn't have residue in it, it's not allowed for use in Canada for reasons of the health of the workers. Yet the product still ends up on our shelves and drives our guys out of business.
Is there a way that Health Canada can deal with that issue?
In your veterinary and drug strategy plan—it relates mainly to Canada and the United States—it says that you would prepare by April 30, 1999, and that was nine years ago, a side-by-side comparison of veterinary drugs approved for use in both countries. I think that was to try to ensure that both countries have the ability to access the same drugs. Has that been done? Is it available to us, and does it include the factors I just talked about, where they have different worker restrictions from ours? It's a huge problem. It's the same thing in China—you can kill a worker, but don't allow residue to come in.
:
When you look at a drug submission evaluation, that is the sole responsibility of Health Canada. Our interactions with Agriculture Canada and CFIA are really based on some of the policy initiatives as we move forward. So when we talk about personal use importation and the fact that farmers are able to bring drugs across the border for personal use, that's a bigger policy issue; it has implications for the agricultural industry. So our interactions with Agriculture Canada are based on policy initiatives.
CFIA does a lot of our enforcement actions. For example, when we had the issue of carbadox in pigs, the CFIA was responsible for the enforcement of some of the MRLs that we talk about.
So our interactions with CFIA and Agriculture Canada are really on strategic or policy issues, on how we move forward. Health Canada cannot look solely at what they do in terms of their own responsibility; we have to make sure we understand other people's issues, other organizational issues, as well.
The backlog is going to be reduced. As we said, there will be an elimination of the backlog by 2009. That's clearly the responsibility of Health Canada; it's within Health Canada's control. And these submissions are not farmed out to Agriculture Canada or CFIA. But there's certainly interaction in terms of how the products would be used, what kinds of enforcement or risk management strategies we may want to have as we move forward, especially if it's a drug that might have specific safety issues in animals, or where MRLs may be difficult to establish, etc. So those are the interactions that occur with the other departments.
CAHI is reporting there is a considerable issue in terms of the market share for industry, and this is decreasing competitiveness. Industry does not want to bring in these drugs, because if people are going to be able to get them more cheaply from across the border, then why should industry go through the regulatory process to do that?
One of Health Canada's concerns with personal use importation is if products are coming from China, India, or other countries where the standards are not identical or similar to the standards we have in Canada, we would have an issue. All you would need would be a safety issue because of an adulterated product coming across the border, and it would be huge.
So we've put together a task force. We did this in early 2007. Livestock producers are involved, CAHI is involved, and Agriculture Canada is involved as well. We brought them together and said we recognize the price differential issue for agriculture. We have to create an environment that's conducive to competitiveness for people to want to come in and file a submission, so that we would have these types of products. How do we restrict personal use importation? How do we make sure that what we are getting from across the border is not substandard or adulterated?
This is what we are working on right now. We are hoping that the task force will come up with some recommendations that will allow us to move forward.
:
Thank you very much for your question.
Drugs that are not authorized for sale, which means those that have not had the issuance of a notice of compliance, can be made available to veterinarians for use through two processes. One is the emergency drug release process, and the other is the investigational new drug submission process. So the emergency drug release process allows for the use of these products that are not authorized, because they are not on the market and there is a therapeutic need to use them in animal care.
For example, some of the aquaculture drugs come through the emergency drug release program. They are not authorized through that program without a review and an evaluation, so some element of review and evaluation occurs. We set up maximum residue limits for those products if they are used in food-producing animals, and there are withdrawal times. That is one process by which drugs that are not authorized for sale in Canada can be used appropriately and very prudently for animals.
The other process is the investigational new drug submission. That is the process I talked about earlier, where we are encouraging industry to come in with these types of trials. It's a controlled study that will collect both safety and efficacy data about a drug. This information is useful when they file their new drug submissions so they can get approval for these products. So there are mechanisms by which these unauthorized products can be made available in Canada if there is a need.
:
The appropriate use of drugs in any situation, whether you're talking about human drugs or veterinary drugs, is a shared responsibility. Industry has the responsibility to develop drugs that are safe and efficacious. Health Canada's responsibility is to review that information, evaluate, and make a decision as to whether those drugs are issued a notice of compliance and put on the market.
Veterinarians, as well as physicians, when you look at human drugs, have the responsibility to use these drugs appropriately. That's the reason for having our package inserts and the information that accompanies a drug when it is marketed in Canada. There is information there. There are systems in place. Obviously, CFIA does monitoring of residues, and where there is an issue, these things are followed up.
So I think we need to look at this as a real, shared responsibility. That's the reason why, when we look at a lot of our policy initiatives, when we look at personal use importation, and when we look at off-label use of drugs, which is when drugs are approved for one species and used in another, CDMA is also at the table. It is so they understand that they also have a responsibility.
:
Thank you very much, Mr. Chair.
Thank you, Ms. Mithani and Mr. Hills, for coming today.
I have some concerns. I'm not exactly convinced that Health Canada necessarily understands the importance of the competitiveness issue and the price disparity between the United States and Canada for drugs such as IVOMEC. It's not an uncommon story to hear of producers who fly down to the United States, buy a truck, fill it up with their quarterly use of IVOMEC, bring it back up, pay the GST and everything else on it, and actually save the price of the truck in their drug costs alone. So this is a very important issue, and I'm a little concerned.
It doesn't seem that you're a big fan of personal use importation. I'd like you to walk me through it a little bit. There is an application form the producer would have to fill out for Health Canada before going down to pick up this drug. Is that correct?
I've seen these application forms. They're not exactly small forms. They're very detailed and very onerous for the producers, which I have a problem with, as well. Nonetheless, how would you have these drugs coming from other countries like China or somewhere else that we don't want coming into Canada? Do they not have to get approval from Health Canada first?
:
Personal use importation does not mean approval from Canada. So you're right that farmers can go across the border and get ivermectin that is cheaper than when it comes into Canada. Health Canada understands the issue of the price differential, which is why we have our personal use importation task force. When we talk to companies or when we talk to livestock producers about why there is a price differential and why these companies aren't coming to Canada and filing their submissions....
It would be easier if these drugs were available at the same price in Canada instead of having livestock producers going across the border to get these particular products. One of the issues is the regulatory approval system. We have a cumbersome, onerous system in which requirements may be different for the U.S. and Canada.
So one of our process improvements and one of our priorities for this year is to come up with a streamlined process for generic submissions so companies in the U.S. don't have extra requirements in Canada. They are able to file their generic submissions here in Canada so that these drugs can be made available. Only if you have these drugs available in Canada are you going to increase the competitiveness of the marketplace here in Canada.
That's what we've been working with on the task force. The intent is that when we eliminate the backlog, when we have an environment that is conducive to competitiveness, and when we have these generic companies coming here to the Canadian market, the price will go down for the innovators and for the other generics that are available. It will be a competitive market. When we get to a stage, which is going to be very soon--within the next year--when we are reviewing on time, industry will be able to file virtual submissions in both the U.S. and Canada.
Then we have to really look at personal use importation. Is there really a need for livestock producers to be going down south? The concern is the potential adulteration of these particular products and where they're coming from. How do you restrict? It's not closing the loop; it's how you restrict to ensure health and safety.
:
We don't have tangible evidence that it has come back, but we certainly have a commitment from CAHI, which is coming in for pre-submission meetings.
One of the conversations we've had with CAHI through the advisory committee is about coming in very early during the drug development. If they come in early, if we are able to very clearly give them what our requirements are, if we provide them with clarity and guidance in the regulatory requirements, these studies will be done in Canada. And if these studies are being done in Canada, then that will bring R and D.
We are having that dialogue. It's in their best interest to be able to bring these particular products very early on. It will bring R and D and it will improve efficiency in terms of the approval process.
:
It has really levelled off in the last little while, because we haven't had as many investigational new drug submissions come in.
The beauty of having the clinical trials done in Canada is that you really have the veterinarians engaged in the development process. That's where we are going and that's what we want to do, which is why we are bringing these people to the table.
Optimally, the objective is to be able to have these studies conducted in Canada. If veterinarians are engaged, they are the ones who would provide the recommendations to Health Canada in terms of “Sure, there's a regulatory review and approval process, but by the same token, in the real world this is how these drugs are used or may be used, and how do you reconcile that?”
Thank you for being here today.
You made a statement on page 6 of your brief. I'm always interested in the words people choose to communicate something. You said that Health Canada was aware of the desire from livestock producers to increase regulatory compliance and that the department was working toward increasing its efforts.
Are you increasing your efforts or are you working toward that? What are you doing with these international standards and international bodies to get alignment of these regulatory requirements? I'm assuming that's part of the way to addressing the backlog in the long term.
:
Yes, and you make a very good point. We are looking at international cooperation. When we look at the MRLs we have in Canada versus those in the U.S., we are 75% harmonized. Our default position is the Codex, where there are issues.
The calculations of maximum residue limits are not harmonized, so every country has its own methodology for assessing them. It's one of those things we really need international cooperation on so we are able to have similar or identical standards as we move forward.
We are actively pursuing international cooperation. For example, right now we have an MOU with the U.S. and an MOU with Australia. We are looking at their systems. We get review reports through industry that facilitate the review of the products we are looking at right now, because obviously some of the products in queue right now in the veterinary drugs directorate are products that have already been on the market for several years in the U.S. The idea is you're looking at a pre-submission package, but a lot of the real safety information, the drug use, may be in the post-marketing area. So how do we leverage or capitalize on the information that's available internationally to facilitate our review process?
So there is a lot. We are actively working on the cooperation.
As we look at generic guidelines, that's another thing we're looking at: the requirements there are in Europe, in the U.S., in Australia, and how we create a regulatory requirement for these types of submissions so we are not onerous.
On Mike's point, we're seen as a high regulatory cost area by companies applying for drug approvals. We're not a big market. We like to think we are, but Canada as a whole, compared to the United States, is not. That's just to point out that I think certainly most of us around this committee feel that the cost should be kept very low, that we can't be a higher cost regime than our competitors or it's difficult for our producers.
I want to make one point as well on emergency approvals, based on Lloyd's question. I don't want to leave the impression, at least from my own point of view, that we're opposed to that, because sometimes it is necessary. I've made requests myself for the horticultural industry, where there is a pest and there is a product in the United States that may be approved by their system and not in ours. I think there was a product in Mike's area in aquaculture that we had to approve one time under emergency approval. So that system is important to us and is necessary, as long as the proper guidelines are in place.
You'd mentioned in your opening remarks that a number of companies have decided not to file their submissions here, implying probably the high cost of doing so. I'm not sure why. Is it because there's a backlog? Is it because there's a high-cost regime?
When we get over this backlog, does Health Canada have any strategy to inform industry that we are a place for R and D, that they should be asking for approvals under our system parallel to the United States? That's important. We have to have access to the same kinds of drugs as they do.
I'll tell you how serious this is from a producer point of view. A producer in my riding couldn't use a feed additive for pork for five years. It got approval last year. He went broke on December 19, just before Christmas, as a hog producer. The cost, according to his calculation, of not being able to use that feed additive on his production base over that five-year period was $470,000. It had made that much difference, and he might still have been in business today.
So that's why I think you see us raising the concerns on the cost end. That is an example of how our cost regime and our lack of quick access to the same products as are available everywhere else has an economic impact on rural Canada.
Anyway, my question is on your backlog and the reason for submissions not being done here. Do you have a strategy?
:
In response to your question, I believe the reason that companies are not coming is not because of cost recovery or the cost of submissions. It was because of two reasons. One was the fact that when submissions came in, they were evaluated on a case-by-case basis and there were no clear-cut guidelines on what requirements were. We've moved forward in articulating what our requirements are, and we continue to do so. We have a guidance document that articulates the requirements for drug submissions. So we are very clear in what we want. We weren't clear before.
Secondly, we had the backlog, and there was no incentive for industry to come in at the time when their submissions would take three years, five years, or eight years for approval. We've put in place process improvements such that we are beginning to eliminate the backlog. Our strategy as we eliminate backlog is the sustainability of being able to continue to review on time.
We've had discussions with the CAHI in encouraging their members to understand that we're getting rid of the backlog. We're eliminating backlog such that we are going to get submissions coming in. We've also talked to the livestock producers in saying that when you go to those companies in the U.S. you are buying drugs from, you have to tell them that we've reduced the backlog, that there will be elimination of backlog, and that there is a real opportunity to bring those drugs in.
I think we also need to understand that in order for us to be competitive, it's a shared responsibility. Health Canada's responsibility is to review on time, and we are committed to do that by early 2009. There has to be a commitment from CAHI to bring these drugs into the Canadian market, because Health Canada cannot make people bring in drugs, cannot make a manufacturer file a submission. They have to be encouraged to bring those in.
I think livestock producers also have a role to play in encouraging companies to come in with these submissions. If these are the drugs they truly require, it really has to be a partnership, and we're committed to that partnership.
:
There are a couple of things. We're talking about elimination of backlog. By early 2009 there will be no backlog; it will be review on time. Our review-on-time timelines are 300 days.
We've also said to industry that if they brought in submissions earlier, during the early drug development phase when we are able to tell them what our requirements are, and were developing those products based on our requirements—which, by the way, would be very internationally harmonized, so we would not really be asking for any more than what any other regulator would be asking—there would be an opportunity to further decrease that timeline.
The fact that companies will be able to file a virtual submission in two or three or four countries will decrease PR costs by allowing them to use that same submission with the same data across the world.
There are approximately 180 submissions that were in backlog when we started at the beginning of this year. We have addressed that backlog by targeting greater than 90% of that backlog. The backlog is basically saying that if a submission is beyond our published time under our management of regulatory submissions, which is, say, 300 days for a new drug submission, it would be considered backlog if it were at 301 days.
We have addressed over 90% of that this year, meaning that this year—right now, as we speak today—there are approximately 50 submissions that we would consider to be in backlog right now. So we've made a significant difference between that and this year.
By the time we finish the fiscal year this year, towards the end of 2008 or the beginning of 2009, those 50 submissions as well as any new submissions coming in will be picked up and be reviewed on time, meaning that by fiscal year 2009 we'll be in a position such that all submissions will be reviewed within our management of regulatory submission timeframes.
:
A percentage? We've increased our notices of compliance, which is the authorization for market access, in a number of ways.
If I look at new drug submissions or abbreviated new drug submissions, out of those 130 I would estimate that somewhere between 70% and 80% went to notice of compliance, meaning that the ones that are carrying over this year will be ones for which we've maybe gone through one review cycle and on which more information will come out.
It means, then, that our overall time between picking up a submission and then getting it out to a notice of compliance would be very consistent with that of our international people with those backlog submissions.
:
We have about 98 people working in the veterinary drugs directorate. The veterinary drugs directorate is made up of veterinarians. We have toxicologists. We have pharmacologists. We have chemists who specialize in chemistry and manufacturing. We have some people who do policy. I could come back with some numbers for you.
We have three divisions. One is the clinical evaluation division, which looks at a submission from the animal health and safety perspective. We have another division, the human safety division, that's involved with antimicrobial resistance. They are involved with the setting of MRLs, the international cooperation in terms of harmonization with MRLs, and withdrawal periods. Then we have the chemistry and manufacturing division, which looks at the chemistry and manufacturing of the products coming through.
There is real interaction here. When a submission comes in, it's divided into three parts--chemistry and manufacturing; if it's a food-producing animal, then a chunk of the submission will go to the human safety division; and then it's clinical evaluation. So there's real interaction between these three, coming in at regular intervals to talk about the drug so that everybody is aware of what's going on before a decision is made to approve, to send a letter for additional data, or to reject.
:
The people who are in the veterinary drugs directorate report to a director general, and are within the Health Products and Food Branch. We have close ties with Agriculture Canada.
For example, if there are enforcement issues, the human safety division will talk to CFIA, or if CFIA finds an adulterated product, they will ask for a risk assessment from Health Canada that will provide them with recommendations on whether it's a level one recall or a level two recall, what they need to do, if the risk of this particular adulteration would high or low, and what strategy CFIA would use then to enforce the compliance of these types of products.
So it's fairly different, but there are very close ties with CFIA and Agriculture Canada.
:
I am referring to the number of employees, because you said at the beginning of this meeting that the department has taken measures to save money and improve the registration process. As parliamentarians, we take satisfaction in seeing that taxpayers' money is well-spent and that savings are being made. Nonetheless, our experience tells us that savings often mean cuts.
For example, have there been any reductions in personnel, and if so, in which sector? Did the government ask you to cut down on staff and on expenditures? I think that cuts to staff or other resources run counter to the fact that you want to improve the registration process, in particular.
At the same time, you said that savings have been made and that you want to improve the registration process. Exactly how are you going about it?