Agriculture Committee on April 1st, 2008

[Carol Skelton, Conservative, Saskatoon—Rosetown—Biggar, SK]

You mentioned that Health Canada, CFIA, and Agriculture Canada work through all these steps--the three departments. Now, it has taken five to eight years. So how long would a drug be in each department? Where has the backlog been?

[Dr. Siddika Mithani]

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.

[Carol Skelton, Conservative, Saskatoon—Rosetown—Biggar, SK]

And you said you do have some specific funding now to help you move forward with speeding up this whole process?

[Dr. Siddika Mithani]

Right.

[Carol Skelton, Conservative, Saskatoon—Rosetown—Biggar, SK]

I gather there are some loopholes, though. Could you give us more details about those loopholes and the size of the market you feel Health Canada has been looking at, and how can we eliminate those loopholes?

[Dr. Siddika Mithani]

The most worrisome loophole we have right now is personal use importation. It was also identified in the IFAH report that came out in 2007, the fact that within the regulations, farmers are allowed to bring in drugs from across the border—

[Carol Skelton, Conservative, Saskatoon—Rosetown—Biggar, SK]

For example, ivermectin?

[Dr. Siddika Mithani]

Ivermectin, exactly.

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.

[Carol Skelton, Conservative, Saskatoon—Rosetown—Biggar, SK]

When is the task force going to report?

[Dr. Siddika Mithani]

They have told us that it would be mid-June.

[The Chair, Conservative, James Bezan]

Thank you. Your time has expired.

Madame Thi Lac.

[Ève-Mary Thaï Thi Lac, Bloc, Saint-Hyacinthe—Bagot, QC]

Good morning.

My first question is a follow-up to the discussion between you and Mr. Bellavance. You mentioned certain drugs that could be sold even if they are not yet authorized in Canada. Besides, I read in the document that the veterinarian must entirely assume the responsibility for protecting the animals he treats and for potential infection. However, you are currently allowing the sale of drugs that have not yet been authorized.

Are these drugs being studied? I would like to know more details about the sale in Canada of drugs that have not yet been authorized.

[Dr. Siddika Mithani]

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.

[Ève-Mary Thaï Thi Lac, Bloc, Saint-Hyacinthe—Bagot, QC]

You spoke of emergency sale programs for animals. Is there some procedure for evaluating the urgent nature of certain products such as those which you just mentioned and which could answer to real urgent needs?

[Dr. Siddika Mithani]

With the emergency drug release program there is an evaluation process and we look at the data there. The data may be very limited; it's obviously not enough to issue a notice of compliance. That is why the drug comes in through the emergency drug release program.

There is also evaluation in the IND process. If there is an emerging disease where clearly there is enough data, then we have a case-by-case process whereby a company can come in and say that this is a priority review. Priority reviews of new drug submissions can be picked up very quickly and authorized or reviewed in a very timely manner.

So it really depends. We have a risk-managed approach within the system to allow those emerging drugs to come in very quickly when there are no other therapeutic options available.

[Ève-Mary Thaï Thi Lac, Bloc, Saint-Hyacinthe—Bagot, QC]

You said that the veterinarian assumes full responsibility for protecting the animals he treats and for potential infection due to the presence of drug residues in animals raised for food.

This is a responsibility that you have thrown into the veterinarians' court. What are the further implications of this responsibility?

[Dr. Siddika Mithani]

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.

[The Chair, Conservative, James Bezan]

Thank you.

We'll go to Mr. Storseth.

[Brian Storseth, Conservative, Westlock—St. Paul, AB]

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?

[Dr. Siddika Mithani]

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.

[Brian Storseth, Conservative, Westlock—St. Paul, AB]

Once you have these generics up here in Canada, then there won't be the need for the personal-use importations and the farmers won't do it anyway. So I don't think we need to be looking at restricting it in the meantime. You're looking at a year before the process even starts to become streamlined. My producers can't wait for this process. We need to have access to those markets now. The own-use import program with Clearout 41 Plus is a prime example. The ability for our farmers to go down to the United States has closed the gap from $4 a litre to $1 a litre—and that's our farmers doing it on their own, without Health Canada's help.

You've raised a couple of good points. You talked about two drugs that have been approved in the first application process. In total, how many drugs were put in?

[Dr. Siddika Mithani]

Right now, we have about fifty.

[Brian Storseth, Conservative, Westlock—St. Paul, AB]

And two were approved, while the rest were denied?

[Dr. Siddika Mithani]

No. The number of submissions we have right now I believe is about 193, in-house. In the last 20 years, we have never had a situation whereby a drug has been—

[Brian Storseth, Conservative, Westlock—St. Paul, AB]

I don't mean to be rude, but I understand that during the last 20 years you were very optimistic about the latest round. In the latest round, in which two were approved immediately, how many were in the process? Were only the two submitted?