Agriculture Committee on April 1st, 2008

[Dr. Siddika Mithani]

No, there were many in the process. We can get you the numbers. This is an ongoing process, so we've had a few notices of compliance. It's not just two that have been approved.

My example was to illustrate that when someone talked about the issue of risk aversion, this was a demonstration of some of the processes we have put in place to give us the necessary expertise. This then allows us a first-time cycle in order to approve a product.

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

If you could get us those numbers, it would be much appreciated.

[The Chair, Conservative, James Bezan]

I ask that you submit that information to the committee as quickly as possible.

Mr. St. Amand.

[Lloyd St. Amand, Liberal, Brant, ON]

Thank you, Mr. Chair.

Doctor, I just wondered if you are to any extent involved with pet food.

[Dr. Siddika Mithani]

The pet food issue comes under CFIA. If a pet food has a health claim—and I don't think we have any pet foods with therapeutic health claims—they are reviewed by Health Canada. So the pet food issue is CFIA's.

[Lloyd St. Amand, Liberal, Brant, ON]

The manufacturers of drugs or medications for pets are based where? All over, I assume. But principally, where do most of the drugs come from?

[Dr. Siddika Mithani]

Most of the drugs come from either the U.S. or Europe. Those are the two areas.

[Lloyd St. Amand, Liberal, Brant, ON]

To what extent are they manufactured in Canada, if at all?

[Dr. Siddika Mithani]

The manufacturing of drugs in Canada is fairly limited. We could get that information for you, if you like. CAHI would be able to provide you with that information, and we can get it for you.

[Lloyd St. Amand, Liberal, Brant, ON]

Is there a reason why so few drugs, if any, are manufactured here in Canada?

[Dr. Siddika Mithani]

There's a lot of globalization of industry, and the fact that a lot of these drugs are approved in other countries before Canada may be one of the reasons. I'm not sure. But I would imagine that there is truly an opportunity here in Canada, once we become competitive, to undertake a lot more R and D.

[Lloyd St. Amand, Liberal, Brant, ON]

As I understand it, the competitiveness study that was done, looking east and comparing Canadian performance with performance in Europe, shows that the process is two years or less in Europe and four and a half to five years here in Canada. It's my understanding that, as a result, significant research and development opportunities have left Canada and gone elsewhere. Is that the case?

[Dr. Siddika Mithani]

That's actually the case, I think, on both the human side and the veterinary side. Studies may be cheaper in other countries. That could be one of the reasons. But if it has to do with the regulatory approval process, we can be assured that there is an opportunity for these types of studies to come back, especially with some of the strategies that we have put in place in the last couple of years.

[Lloyd St. Amand, Liberal, Brant, ON]

Is there anything on the ground, though, to reflect your confidence about that possibility?

[Dr. Siddika Mithani]

The proof is in the pudding. Look at what we have done since 2005. If you look at 2002 or 2003, you would have never imagined that we would be where we are right now. The fact that we have put these processes in place and that they are working.... Our interactions with the industry, with the livestock producers, and the policy initiatives that we are moving forward with are a real demonstration of the commitment Health Canada has in balancing health and safety with innovation and being competitive.

[Lloyd St. Amand, Liberal, Brant, ON]

That's no doubt the case. But that being said, is there any tangible evidence that research and development has come back to Canada?

[Dr. Siddika Mithani]

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.

[Lloyd St. Amand, Liberal, Brant, ON]

I have one last question, if I may, Mr. Chair.

Following up on what my Bloc colleague Madam Thi Lac asked, to what extent do veterinarians utilize drugs that have not yet been approved?

[Dr. Siddika Mithani]

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?”

[Lloyd St. Amand, Liberal, Brant, ON]

To what extent does it occur? Is it the exception? Is it twice yearly? Or are there any data on that?

[Dr. Siddika Mithani]

We may be able to get data from CAHI on this. But we can give you some of the information we have in terms of investigational new drug submissions and how many we have had in the last little while.

What will be interesting is to see how we will fare--that will be our benchmark--in the next couple of years, with all the dialogue we are having.

[The Chair, Conservative, James Bezan]

Your time has expired, Mr. St. Amand.

Mr. Allen.

[Mike Allen, Conservative, Tobique—Mactaquac, NB]

Thank you, Mr. Chair.

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.

[Dr. Siddika Mithani]

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.

[Mike Allen, Conservative, Tobique—Mactaquac, NB]

Have you set a target date in these discussions to close that gap of the remaining 25%? You said 75% was harmonized in one of those areas. What is your target date for closing this gap?