Evidence of meeting #36 for Health in the 41st Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was market.
A recording is available from Parliament.
10:35 a.m.
Liberal
Ted Hsu Liberal Kingston and the Islands, ON
Let me ask the question again. If pharmacists and others have been talking about drug shortages for a couple of years now, shouldn't the government have been doing a risk assessment and perhaps not blaming individual companies or individual situations?
10:35 a.m.
President, Canada's Research-Based Pharmaceutical Companies (Rx & D)
If I can offer part of an answer, I think the government has done that. Through the correspondence that's been quoted on a number of occasions, I think the government has instructed the entire chain to work together and come up with a solution.
I actually think the government has played an important role in pushing us all together to come up with a solution. Without getting called by the chair, it is a complex issue, and we are trying to work through the issues. But I think they have.
10:35 a.m.
Liberal
Ted Hsu Liberal Kingston and the Islands, ON
Okay.
I have a question for Mr. Robidoux. Going back to another question earlier, there was a particular presentation on morphine. There was a packaging issue. Is that issue related to the overall problem of drug shortages, or is it a different problem?
10:35 a.m.
President, Sandoz Canada, Canadian Generic Pharmaceutical Association
Regarding the correctly labelled morphine product put in a wrong box, we've acted rapidly to not only secure patients' safety by recalling the products and putting all of the products in quarantine, but we've worked rapidly with Health Canada to reinspect the 10,000 boxes of 10 ampoules and resupply the market.
As of today, Madam Leitch, this format is available to pharmacists in the country.
10:35 a.m.
Liberal
Ted Hsu Liberal Kingston and the Islands, ON
Was the problem that caused the packaging issue related to drug shortages?
10:35 a.m.
President, Sandoz Canada, Canadian Generic Pharmaceutical Association
It's clear that a recall could potentially create shortages.
10:35 a.m.
Liberal
Ted Hsu Liberal Kingston and the Islands, ON
You're telling me that those two problems, the drug shortage problem and that particular presentation, the packaging issue, had the same root causes. Do they share root causes?
10:40 a.m.
President, Sandoz Canada, Canadian Generic Pharmaceutical Association
I think one is creating the other.
Any recall of any particular drug in a market, depending on that drug and the situation—is it a single source or is it multi-source?—might lead to shortages.
10:40 a.m.
Conservative
The Chair Conservative Joy Smith
Thank you, Mr. Robidoux.
We have time for one more question, and next in line is Ms. Davies.
10:40 a.m.
NDP
Libby Davies NDP Vancouver East, BC
Thank you very much.
First of all, Madam Chair, I'd just like to say that it's duly noted that you've intervened to tell witnesses when they haven't answered the question, so we'll certainly expect the same standard when government officials or the minister appears. So that's good.
I am concerned by the responses today, because it seems to me that we're being told on the one hand that this is all terribly complex and on the other hand not to worry about it—we have a good system in place, the government has done a great job, and things are okay. Yet I don't feel that way at all, and I don't think many Canadians feel that way.
We will be focusing a lot on the motion that was passed to find out what this national strategy would look like and what the required reporting will look like.
I want to switch to one question, though. We know that the Auditor General identified problems with the approval process in the fall of last year. We know that the minister has said that there's now an expedited process in place. But in the longer term....
What are some of the problems you've had with the approval process? We know that it takes up to two years. Are there things we should be doing in a more systemic way to look at the length of the approval process?
10:40 a.m.
President, Canadian Generic Pharmaceutical Association
From the generic company perspective, we have been urging Health Canada to put more resources into drug approval for some time. We have been unhappy with the length of time it takes for drug approvals. On average, it can take 17 to 18 months for a new generic.
There is a process in place, and the minister has now responded with an expedited system when necessary drugs are in shortage.
The Auditor General reported, and we have been working with Health Canada to try to address that. In general, I think the fact of the matter is that there has been a lack of resources on the drug approval side, which we have been concerned about.
10:40 a.m.
NDP
Libby Davies NDP Vancouver East, BC
I have one quick question. Could you tell us whether any of your member companies hold market authorization for certain products but don't market them? Do any of your member companies have an authorization to produce certain products, but they're actually not doing that?
10:40 a.m.
President, Canadian Generic Pharmaceutical Association
That can happen sometimes.
10:40 a.m.
President, Canadian Generic Pharmaceutical Association
I don't have data for you today. Companies sometimes get approval and then find that they are unable to supply a product.
10:40 a.m.
NDP
Libby Davies NDP Vancouver East, BC
Is it possible to get that information from your association? Could you supply that to the committee?
10:40 a.m.
President, Canadian Generic Pharmaceutical Association
Sure.
It's fairly common among all manufacturers.
10:40 a.m.
NDP
Libby Davies NDP Vancouver East, BC
Right. My next question is to the patented products.
Is that also an issue? Are there companies that have an authorization but they are not actually putting their products on the market?
10:40 a.m.
President, Canada's Research-Based Pharmaceutical Companies (Rx & D)
I can't answer that question. Let me get you that information. I'll supply it to the committee.
10:40 a.m.
NDP
Libby Davies NDP Vancouver East, BC
Okay.
I'd appreciate it if both associations could let us know that information.
Is there more time?
10:40 a.m.
NDP
Libby Davies NDP Vancouver East, BC
I would like to come back to this question of sole source, because there has been a lot of debate about that. I think HealthPRO has said that they are now looking at other backups, and I think that's very important.
I just wanted to focus on the patented drugs. We focus a lot on the generics, but in actual fact, each patented drug is a sole source. I'm not clear about how one would deal with that, because you're dealing with an individual product.
I don't know if the HealthPRO representative would like to answer. I don't know whether you deal exclusively with generics or whether you're dealing with patented drugs as well. How would you deal with the sole source?
10:40 a.m.
Vice-President, Services, HealthPRO Procurement Services Inc.
We receive competitive bids on genericized products only. Although we contract for patented products, we don't have an opportunity to find alternate sourcing when the product is still under patent protection. What we will be doing in the future is looking at where a product has come off patent and either other market authorizations have been issued in Canada or other companies globally can apply for market authorization.
Those are the areas where we will be putting our efforts to bring additional supply to Canada.