Agriculture Committee on April 1st, 2008

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

—how many were approved?

[Bob Hills]

I'd have to dig out the exact numbers.

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

Give me a percentage?

[Bob Hills]

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.

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

But notice of compliance is not an approval.

[Bob Hills]

It's an approval process. It gives the companies the ability to market the products in Canada.

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

So roughly 80% have been approved?

[Bob Hills]

Yes, it's somewhere around there--of what we picked up this year.

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

Was the problem with them before the maximum residue levels, or what was it?

[Bob Hills]

It wasn't necessarily. If I would look at the submissions, some of them may be for companion animals; some of them may be for food-producing animals. If it was for companion animals, it would not be a maximum-residue-level-type issue, primarily because they're not food-producing animals. For those ones, we would run into some difficulties with some of the requirements we have around some of the studies that would be required or some of the specifications we're looking for to ensure the safety and quality of the product as it comes into Canada.

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

By early 2009, will we still have products coming from the United States onto our grocery store shelves that contain drugs that our producers cannot access due to issues such as maximum residue?

[Dr. Siddika Mithani]

If you are talking about maximum residues, again, everybody does their own review and evaluation. The thing is that companies have to file those submissions. A Canadian farmer may not have access to those drugs because the drug submission has not been filed with Health Canada. That is why I say we all have a responsibility to encourage industry to bring those drugs to be filed with us.

I cannot tell you that by 2009 drugs will not be cheaper in the U.S., because we will need those generic companies to be filing drug submissions. It's all to do with industry's commitment to filing drug submissions, and that's what needs to be encouraged.

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

In those cases, farmers would still have access to the personal use imports to offset those diversities, and I think that helps substantiate why we need to continue to have this all throughout the process. It does help hold back on some of the loopholes that we have in the generic industry while we are trying to get our country competitive in that industry.

Do you have a comment, Mr. Hills?

[Bob Hills]

While I can understand where you're coming from with respect to personal importation, one of the concerns we continue to have is with the ability to bring in drugs that have not been approved in Canada--or perhaps have not even been approved in the FDA--because maybe they are bringing them in from a country such as India or China or some place like that where we may have a little bit more concern because of the regulatory system that's in place. We haven't gone through that same confidence-building exercise there that we've gone through with the FDA or with others.

The concern would be under personal importation that any drug product, effectively, could be brought in under that particular guise. That means that a drug may not have been approved in the U.S. either. So from a Health Canada point of view, we would always have to have some concern around the loophole that would be there, because the consumer who goes to buy the meat from the Canadian producer or elsewhere doesn't have that choice, so we have to have some mechanism by which we can monitor it. While I can understand what you are saying, we do have to look for those areas where there hasn't been an approved drug product that could be of particular use. -

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

I have two points to finish off, Mr. Chair.

[The Chair, Conservative, James Bezan]

Go ahead briefly.

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

First of all, they still have to file the application with Health Canada, so Health Canada is still aware of the product they're bringing over. Second, if we start getting local producers who are importing from China and India, there is a huge price disparity there for them to be able to get those shipment costs over and still make a profit. I think that really speaks to the uncompetitiveness and some of the roadblocks that are put up by Health Canada on some of these issues.

[The Chair, Conservative, James Bezan]

Thanks.

Monsieur Bellavance.

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

Thank you, Mr. Chairman.

Ms. Mithani, I would like you to give me some details about some points that you raised during your presentation, at the beginning of the meeting. First, I would like to know how many people are assigned to the Veterinary Drugs Directorate at Health Canada, how many of these people are working on registration and how many of them are more involved with drug safety.

[Dr. Siddika Mithani]

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.

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

Do any of your people report to the Department of Agriculture and Agri-Food, or to the Canadian Food Inspection Agency? Some departments work in this way. If not, are you collaborating very closely with the Department of Agriculture and Agri-Food?

[Dr. Siddika Mithani]

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.

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

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?

[Dr. Siddika Mithani]

In order to cut costs, process improvements have been put in place. In order to do an efficient job, it doesn't always mean more money, more staff. The systems that were in place in the veterinary drugs directorate were not harmonized, were not coordinated. We've brought a lot of coordination into the system. We did not focus on international cooperation and harmonization in those times.

So whereas we have introduced efficiencies, we have also introduced cost-cutting, not in terms of having less people but in terms of being able to work more efficiently within the system. That's what was being referred to.

[The Chair, Conservative, James Bezan]

Mr. Steckle.