Agriculture Committee on Jan. 29th, 2008

[Karen Dodds]

That's where we're really making an effort to ensure that the gap is not just not widening but is decreasing. At the same time, as I said earlier, we've been clear that much of the gap was developed from older products. We are not really interested in spending resources on reviewing older products when there is a general recognition that newer products are better for human health and better for the environment. We're really interested in trying to make sure Canadian farmers have access to the newer generation of products that the American farmers have as well.

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

Okay.

Is there more time?

[The Chair, Conservative, James Bezan]

There are only about 30 seconds left.

[Wayne Easter, Liberal, Malpeque, PE]

I'll save it until next time.

[The Chair, Conservative, James Bezan]

Okay.

Mr. Storseth.

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

Thank you very much, Ms. Dodds, Mr. Aucoin, for coming in.

Originally you worked with the grower groups. They had 12 recommendations or priorities that they wanted to see put in the GROU program. Is that correct?

[Karen Dodds]

Apparently there were three sets of priorities.

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

All right. I'm just getting it off your website here that a pilot project for GROU was conducted in which, of the products, there were 12 priorities submitted by grower groups. Now, is it correct that eight of these were used for the pilot project in 2006? How many will actually be included in the GROU program?

[Karen Dodds]

There will be six.

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

So was there a problem with two of the eight? Outside of that eight, how many of the 12 were actually included after?

[Karen Dodds]

We looked at the 12. One of the requirements in terms of the chemical composition that impacts human health in the environment is that the products be the same. Of the 12, a number were eliminated because with a quick review of the U.S. formulation and the Canadian formulation, it was seen that they're not comparable products. Even though some of them had the same name north and south of the border, the formulations were significantly different. That's why of the 12, four of them were found not to be equivalent and were not part of the program. Always for both OUI and GROU, the two products have to be equivalent.

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

And what happened to the two we've since dropped from the pilot program?

[Karen Dodds]

Those two, I believe, dealt with patent issues and how recently they had been brought to market when the registrant still had strong patents on them.

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

So it's PMRA's position then that of the twelve priorities, several of them weren't actually the same product, chemically?

[Karen Dodds]

Right.

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

How successful is your new data protection policy to facilitate registration of generic pesticides?

[Karen Dodds]

It's been very good.

How many submissions have we had already?

[Dr. Richard Aucoin]

I don't have the numbers, but there is a whole series of new chemical submissions that have come in since we began implementation in July.

[Karen Dodds]

There have been eleven.

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

Eleven submissions? How many have been approved?

[Karen Dodds]

I don't think any have made it through yet.

[Dr. Richard Aucoin]

None have made it through yet.

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

And this program started, as expected, in July of last year? Do you have any idea when the first ones will be approved?

[Karen Dodds]

We have a timeline set for how long it will take. I doubt it's shorter than 12 months. So we didn't expected to come to a decision on any of those.

But this is an area where Canada has suffered because there has not been a healthy generic industry in Canada. So what we did with our data protection policy was to make very significant changes. Before, the branded products could in essence evergreen their data protection period by adding in new data at any time they wanted. We put a stop to that. Under our new act, whenever we need or want information, we can demand it of a registrant. So this old custom of the registrant submitting information without our request for it is of no real purpose or use to us. So we set a fixed period for data protection for the branded products, upon which generics can then enter the market very easily. It adds real predictability to the system, which the generic manufacturers told us was needed.

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

But it's going to be at least another six months before we see if it's a real success or not?