Agriculture Committee on April 1st, 2008

[The Chair, Conservative, James Bezan]

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.

[Dr. Siddika Mithani, Associate Assistant Deputy Minister, Health Products and Food Branch, Department of Health]

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.

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.

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.

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.

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.

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.

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.

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.

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.

[The Chair, Conservative, James Bezan]

Thank you.

We will open with seven-minute rounds.

Mr. Steckle.

[Paul Steckle, Liberal, Huron—Bruce, ON]

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?

[Dr. Siddika Mithani]

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.

[Paul Steckle, Liberal, Huron—Bruce, ON]

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.

[Dr. Siddika Mithani]

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.

[Paul Steckle, Liberal, Huron—Bruce, ON]

Would you suggest to us this morning that the arguments being made for allowing further drugs here...that we're at a level where we're equal to or above what the Americans would have? For instance, take the chicken influenza. Are we behind or ahead of the game when it comes to that particular disease? Would you say we're there, that we're not quite there yet, or that they have something we should have? This is something that doesn't regard borders as an issue. This disease can go across borders very quickly.

[Dr. Siddika Mithani]

On specific issues that are transborder and more like pandemics, there is a lot of international cooperation on the types of vaccines you would use. In a case of an emerging disease where there was a company or a therapeutic product that looked promising and that really needed to be introduced in Canada as well as in the U.S., I imagine we would be on fire; we would not be lagging behind.

We have been in a situation in the past where there has been a backlog. Particularly, for example, when you look at the number of generic products that are on the market in the U.S. versus those in Canada, these products have not been introduced into our market. But the intent now is to create an environment that is conducive to bringing in those particular products, so that we are able to have the same access to these products as the Americans, or for that matter even the Europeans.

[The Chair, Conservative, James Bezan]

Thank you, Mr. Steckle. Your time has expired.

Monsieur Bellavance.

[André Bellavance, Bloc, Richmond—Arthabaska, QC]

Thank you, Mr. Chair.

My questions will be along the same lines as those asked by Mr. Steckle. We have a similar problem with the PMRA regarding product registration. Have you looked at the situation whereby products registered in the United States could be used in Canada and are not because there was not enough time to do the required analyses? Perhaps you think that some products should not be on the Canadian market for particular reasons. Has your branch made any effort to provide better product harmonization?

[Dr. Siddika Mithani]

People are working very hard at the moment to put in place a process to ensure harmonization between the two countries.

A lot of effort has been made. The issue is to ensure the products are made available because companies have to file submissions in Canada as well, so there is a system to encourage companies to come to Canada to file those submissions.

[André Bellavance, Bloc, Richmond—Arthabaska, QC]

We have to raise the issue of the length of time it takes for some products to be registered. For example, in the document we received which compared competitivity, we see that European veterinary drugs are registered much more quickly. Generally, it took less than two years to do a risk management study for a group of four archetypal drugs that were reviewed. Whereas here, it takes between five and eight and a half years to do the same work on the same four products. Comparison shows that the registration process does not work very quickly here.

Why is that? Is there a staff shortage, or is it simply that we require more in-depth studies, for safety reasons?

[Dr. Siddika Mithani]

The reasons for the difference between the U.S. and Canada, in terms of the IFAH report you're talking about, have been because we have had a backlog, but processes have been put in place.

The registration system in the U.S. is a little different from the one in Canada, in that throughout drug development you have a system whereby companies will be interacting with the U.S. at all stages during the process. We haven't implemented a process like that. We are beginning to implement that process so we can be on a par with the way the system works in the U.S.

[André Bellavance, Bloc, Richmond—Arthabaska, QC]

I was referring to Europe, but you have confirmed that the process is faster in the United States as well. When can we look forward to having this process not only in place, but actually functioning, so that we have some assurance that the time required to approve drugs will really be reduced?

[Dr Siddika Mithani]

Absolument, parce que the report was up till 2006. The process improvements have now been in place since 2006. We are encouraging industry to come in. We have just set up an expert advisory committee that I talked about in our opening remarks that brings in industry at the beginning, during drug development, so we get the experience of their new drug, just as the U.S. does, just as Europe would do. Therefore, when the drug comes in for a submission, the time taken will be decreased and there will be increased efficiency in the regulatory process as we move forward.

[André Bellavance, Bloc, Richmond—Arthabaska, QC]

Will you be setting some very specific objectives in terms of years?

[Dr. Siddika Mithani]

Absolument. Nous avons the deadlines. Within a submission, we have a guidance that talks about timelines for approval or for evaluation and they are comparable to those in the U.S. They are 300 days, which is comparable to what the U.S. does.

At this point, we do have a backlog. By the end of 2009 that will go, and we will be reviewing on time, which is why I said in my earlier response that we will be at a stage as of 2009 when a company will be able to file a submission at the same time and will be able to get a response at the same time.

[André Bellavance, Bloc, Richmond—Arthabaska, QC]

We hear talk about a market for non-approved products. Does that mean there is a black market or a grey market? Clearly, veterinary drugs do not make the headlines very often, while drugs for people do. For example, it is possible to order products on the Internet from elsewhere, and this is a rather dubious way of proceeding.

In the context of your work, has the branch found that the same type of problem exists in the case of veterinary drugs? If so, do you have a way of trying to manage and control this practice?

[Dr. Siddika Mithani]

We have a similar system, in terms of the fact that there are systems in place to ensure that we don't have that black market you are talking about. We are moving forward with looking at or exploring avenues where we can put in strategies that are going to minimize the kind of personal use importation you might be talking about, getting drugs through the black market. We are looking at those strategies.

Again, we have a task force that was struck about a year ago, in 2007, that is clearly looking at personal use importation, the fact that there are certainly potential health and safety concerns about products that may be coming from China and India via the U.S. or other countries that may pose a risk to humans. We are looking at those strategies.

[André Bellavance, Bloc, Richmond—Arthabaska, QC]

Do you think that there is a risk? Have you analysed any products from this market that, in your opinion, were not compliant and that could put not only animals but also the human population at risk?

[Dr. Siddika Mithani]

We haven't had an issue like that so far, where we've done an analysis showing that we have adulteration. But we certainly have MOUs, memoranda of understanding, with other countries, so that if there are international issues that are identified, they will provide us with an opportunity to look at our market and to be able to do these kinds of tests and inspections and investigations as we move forward.

[The Chair, Conservative, James Bezan]

Thank you very much.

Mr. Lauzon.

[Guy Lauzon, Conservative, Stormont—Dundas—South Glengarry, ON]

Thank you, Mr. Chairman.

First, I would like to welcome our witnesses, Ms. Mithani and Mr. Hills.

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?

[Dr. Siddika Mithani]

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.