Evidence of meeting #36 for Public Accounts in the 41st Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was drug.
A recording is available from Parliament.
Conservative
Daryl Kramp Conservative Prince Edward—Hastings, ON
Thank you, Chair.
Mr. Glover, you made a statement, and maybe I didn't hear it right. I'd like a little clarification, if you would. It was with regard to your comment on Sandoz. You mentioned they have three plants, two in Canada and one in the U.S. Yet the problem that surfaced came from the U.S. plant, if I heard you right.
So if that is the situation, why are we having a problem with availability of their product here in Canada?
Assistant Deputy Minister, Health Products and Food Branch, Department of Health
Mr. Chair, I'll try to be as clear as I possibly can, perhaps it was my miscommunication.
Sandoz has a plant in Boucherville, Quebec, and two in the U.S. The FDA inspected all of those. The FDA was concerned with what it saw in the Boucherville plant in Quebec, with respect to a product that they make there that is not sold in Canada. It is sold into the U.S. That was what the FDA found. They issued a warning letter to Sandoz saying they had this concern, and Sandoz had 30 days to respond with a plan to address that concern.
We also inspect Sandoz and its plants, just as we inspect all plants that provide product to the Canadian market, or we work with international partners to make sure they all get inspected. In the particular case of the Boucherville plant, we had been in and continue to be in it. We were in just last Friday, given the packaging mix-up. Our inspection found a number of problems, and we noted those problems and asked them to follow up with how they would respond to those observations. They were still compliant. We didn't feel the plant needed to be shut down. It could still continue operating, but we wanted to see further improvements in their operations, and that is fairly standard in terms of all our inspections.
Conservative
Daryl Kramp Conservative Prince Edward—Hastings, ON
Okay, but there's no restriction on their product coming out to Canada?
Assistant Deputy Minister, Health Products and Food Branch, Department of Health
No. We were monitoring and watching that.
The ultimate issue, if I may, was a business decision by Sandoz, in terms of responding and how they chose to respond, that has resulted in this. They could have responded to both the FDA warning letter and to our reports differently than they have chosen to.
Conservative
Daryl Kramp Conservative Prince Edward—Hastings, ON
Okay. Thank you very much.
I have three quick questions for Ms. Yeates, if I have an opportunity to get them in.
Just for common knowledge, I was talking to the minister of revenue the other day, and 42,000 people work for Revenue Canada. How many people work for Health Canada?
Conservative
Deputy Minister, Department of Health
It's in the neighbourhood of $3.7 billion.
Conservative
Daryl Kramp Conservative Prince Edward—Hastings, ON
Thank you very much. Are you currently involved in any litigation?
Conservative
Daryl Kramp Conservative Prince Edward—Hastings, ON
You're in several litigations? Thank you.
Can you just quantify, one, two, three, five hundred. Give us an approximate—
Deputy Minister, Department of Health
I wouldn't have that number with me. I'll just give an example the committee might be aware of. We are often the third party in a significant number of tobacco litigations, but there would be a number of others.
Conservative
Daryl Kramp Conservative Prince Edward—Hastings, ON
Fine, thank you very kindly.
That's enough, Chair.
Liberal
Gerry Byrne Liberal Humber—St. Barbe—Baie Verte, NL
Thanks, Mr. Chair.
I just want to follow up on Mr. Maxwell's comments. In 2004, the Standing Committee on Health recommended that the department, Health Canada, create a public database on clinical trials. That was in 2004. Are you committed to establishing a Canadian, Health Canada-administered database on clinical trials?
Deputy Minister, Department of Health
We are very committed to making clinical trial information more transparent, and we are currently in consultation about the best way of doing that. As the clinical trial sites become multinational, the question of whether we should build a Canadian-only site, or whether we should require companies to put their clinical trial information on international WHO-sanctioned sites, which we have been encouraging companies to do, is a question that is still outstanding.
Canadians, I think, are interested. Some of these clinical trials are with patients who have very specific conditions. You'll be interested, as a parent or as a family member, in knowing what is happening in the sites in Canada and also whether those drugs are being tested internationally.
Liberal
Gerry Byrne Liberal Humber—St. Barbe—Baie Verte, NL
Would it be fair to say that the answer to the question is no, until convinced otherwise?
Deputy Minister, Department of Health
When I mentioned that we are doing consultations and are exploring this, that is precisely the kind of thing we are exploring. We want to build something here. We want to go down the path that is the most useful to Canadians.
Liberal
Gerry Byrne Liberal Humber—St. Barbe—Baie Verte, NL
Not to be too critical, but it has been eight years. I'll just leave it at that.
I have a question about drugs the department rejects and drugs the manufacturer withdraws from the review process. You're not disclosing any information. What specifically do you intend to do to rectify that?
Deputy Minister, Department of Health
We are, in fact, moving in that direction. That will be when we come back with our commitment here. We have been—
Deputy Minister, Department of Health
We do intend to take that step to make sure. Right now we have a plan, and as the committee has requested, we will be even more specific about the steps in this plan. But we will broaden our information so that Canadians have information on conditions and rejections, for example.
Liberal
Gerry Byrne Liberal Humber—St. Barbe—Baie Verte, NL
Does the department do any foreign inspections of plants, like the USFDA did to Sandoz in Quebec? Do we do foreign inspections?
Deputy Minister, Department of Health
Yes, we do, but I'll ask my colleague to speak to the specifics.
Assistant Deputy Minister, Health Products and Food Branch, Department of Health
We do a number of foreign inspections, and we also have what we call mutual recognition agreements, where we have gone through confidence-building and rather than constantly going all around the world, we work with our international partners and exchange information. For those that we have mutual recognition agreements, we collaborate and coordinate, and for those that we don't, we do foreign inspections.
