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Evidence of meeting #38 for Health in the 41st Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was shortages.

A recording is available from Parliament.

On the agenda

MPs speaking

Also speaking

Brian O'Rourke  President and Chief Executive Officer, Canadian Agency for Drugs and Technologies in Health
Jeff Poston  Executive Director, Canadian Pharmacists Association
Joel Lexchin  Professor, School of Health Policy and Management, York University, As an Individual
Jeff Morrison  Director, Government Relations and Public Affairs, Canadian Pharmacists Association
Paul Glover  Assistant Deputy Minister, Health Products and Food Branch, Department of Health

9:05 a.m.

Conservative

The Chair Conservative Joy Smith

Thank you very much.

We'll now go to Dr. Joel Lexchin, professor in the school of health policy, as an individual.

9:05 a.m.

Dr. Joel Lexchin Professor, School of Health Policy and Management, York University, As an Individual

Thank you very much, Madam Chair, for the invitation to appear here.

I have a couple of roles. First of all, I work as an emergency physician in downtown Toronto, and secondly, I teach health policy at York University. Moreover, I've been studying pharmaceutical policy issues for about 30 years now.

With regard to the first role, just yesterday we were discussing drug shortages in the emergency department at the University Health Network. We've had to modify certain practices because of these shortages. I'm well aware of the impact that drug shortages can have on doctors' prescriptions and patient care, which is what we're all concerned about.

I think drug shortages have been on the horizon for a number of years now. We've certainly been aware of them in the emergency department for a few years. It should not come as any surprise that we're now in more of a crisis situation. All it took was a fire to create a crisis.

What we need is proactive planning to avoid any similar situation in the future. Merely approving other generic manufacturers that are able to produce drugs is not really proactive planning. We need to go beyond that, and in that context I have a number of suggestions.

I believe that Health Canada should convene an expert committee to identify off-patent drugs. Most of the products we're concerned about are generics, off-patent, that are supplied by only one or two companies. They are considered critical to medical care. Examples of these critical products might be chemotherapeutic agents, morphine, anesthetic agents, or drugs to treat epilepsy.

Once these critical drugs have been identified, Health Canada should proactively identify possible alternative sources of these products and determine whether the companies making them are prepared to supply Canada in the event of an emergency. Contingency contracts could then be negotiated with interested suppliers.

In the future, any company marketing one of these critical drugs in Canada should be required to give Health Canada a minimum of six months' notice before they stop supplying the product, and Health Canada should maintain a list of these drugs and post it publicly.

One of the conditions for granting a notice of compliance to sell one of these critical drugs in Canada should be a commitment by the company to guarantee the availability of the drug for a minimum of three years. We already go beyond what's required in the Food and Drugs Act when we approve drugs or give them a notice of compliance; we now invoke patent issues, so asking for a commitment to supply the drug doesn't really break any new ground.

Finally, if we do have another crisis similar to the one we have now, we need to avoid any possibility that companies can take advantage of the situation by charging a premium for their products. In that regard, I think the federal government should consider establishing a publicly owned generic drug company to manufacture some of these drugs to ensure that the drugs will not only be available, but will be available at a reasonable price.

Thank you very much for your attention, and I welcome the chance to answer any questions.

9:10 a.m.

Conservative

The Chair Conservative Joy Smith

Thank you.

Go ahead, Ms. Davies.

9:10 a.m.

NDP

Libby Davies NDP Vancouver East, BC

Thank you, Madam Chair.

Thank you to the witnesses for being here today. You've really helped illuminate not only the problem but also what we need to do. I really appreciate that. I want to jump right in and focus on what we can do.

There's something in the pharmacists' report from December 2010 that you distributed that you didn't exactly say today, but it's very clear in your report, and I'd like to quote from it. On page 11, under “causes”, you say:

What is missing in the drug supply chain is any organization or party that holds accountability for the supply chain from a system-wide perspective. Neither government nor any third party has an oversight function for the drug distribution system, and therefore drug supply is dictated in large measure by the market.

You go on from there to spell that out a little more.

I think this is a very telling comment, because everybody is saying from varying perspectives that there is no oversight, no mechanism to do this. We're completely reliant or dependent on, or held captive to—however you want to put it—what's going on in the marketplace.

I would also comment that in the brief that was just presented by the Canadian Agency for Drug and Technologies in Health, you also point out that the drug shortages are often difficult. You mention the mergers and the reluctance to share details of the shortages, again for business case reasons.

There are two questions that I would like to get at and have you answer. First of all, Mr. O'Rourke, you suggested that your organization might be able to fulfill that function as an independent overseer of information and in looking for substitutes. I'd like you to spell out how you could take that on and how quickly. I'd like others to comment on whether or not that is feasible.

Dr. Lexchin, in your brief you speak about establishing a publicly owned company. I was very interested to read in your brief that in the mid-1980s there actually was such a publicly owned company, called Connaught Laboratories. I don't recall that myself, but I wonder if you can speak a little bit more about this. I think your recommendations are great. This additional one about having a publicly owned company to ensure that some of the essential medications are there and that we won't have to face these kinds of shortages is a very brilliant suggestion.

I'd like you to speak a little more on how Connaught Laboratories worked, if you have that information. I don't know what happened to it, why it went under, or whether it was just done out of business by the government. Then I'd like the others to address the question of what kind of independent agency we need to provide this oversight.

9:15 a.m.

Conservative

The Chair Conservative Joy Smith

Who would like to take that question?

9:15 a.m.

President and Chief Executive Officer, Canadian Agency for Drugs and Technologies in Health

Dr. Brian O'Rourke

Madam Chair, I can probably speak to part of that question. On having one single agency to provide that oversight from a purchasing perspective, that wouldn't be CADTH. We do not have the expertise in purchasing, and a lot of that purchasing aspect is done through the group purchasing organizations.

We think we might be able to play a role if and when we have future shortages. I have been a pharmacist for many years myself. We've faced shortages in drug supply ever since I've been a pharmacist, and we've dealt with them.

What we're dealing with now, however, are more frequent drug shortages. Making those preparations and having clinical information available to pharmacists, physicians, and patients is where we think we could play a role. We can be proactive in identifying, as Dr. Lexchin said, critical drugs for which there is perhaps only one supplier and for which some information needs to be available to clinicians. That's more the role we would play, versus having a role in the oversight of the procurement.

9:15 a.m.

Executive Director, Canadian Pharmacists Association

Dr. Jeff Poston

If I can add to that, I think it's a great question but a difficult one to find a solution for, because you have to look at some sort of partnership between the federal government and provincial governments to do so. Provincial governments make some effort to protect themselves, if you like, from the impact of shortages, with some generic drugs that have exception status on the formularies. When they’re single-sourced, they may be allowed to be sold at higher prices. The provincial governments have a role.

I think the federal government also has an important role. Health Canada has been developing some of that. We've seen it as a result of the Sandoz shortage.

Historically we've had this issue of the supply chain falling through the cracks. It's not something that is strictly the federal government's responsibility or the provincial government's responsibility. People have been happy to allow the manufacturers or pharmacies to manage the supply chain.

We certainly need a lot of discussion to work out the structure of some oversight agency. I think gathering data and gathering information is the first step.

One thing we have to think about is that we spend a lot of time regulating and approving new drugs that come onto the market. Then the organization that Mr. O'Rourke is responsible for, the common drug review, decides what's going to get listed. As a result, we spend a lot of time looking at what comes onto the market.

One thing we've got to look at is what goes off the market. One problem we've seen with a lot of drugs that have gone into shortage—and Sandoz is a specific issue of manufacturing, and that is another issue—is that they're old drugs. They've been generic for some time. They're low-value often low-volume drugs, but they're still clinically important. I think we have to look at how to address some of these older drugs that have been around for some time and how to keep them on the market.

9:15 a.m.

Conservative

The Chair Conservative Joy Smith

Thank you, Dr. Poston.

We'll now go to Dr. Leitch.

April 3rd, 2012 / 9:15 a.m.

Conservative

Kellie Leitch Conservative Simcoe—Grey, ON

Thank you very much, everyone. I really appreciate your presentations.

My first question is for the Canadian Pharmacists Association. I apologize; I don't know if it's Dr. Poston or Mr. Poston.

9:15 a.m.

Executive Director, Canadian Pharmacists Association

Dr. Jeff Poston

I've got a Ph.D., so you can say Dr. Poston.

9:15 a.m.

Conservative

Kellie Leitch Conservative Simcoe—Grey, ON

I didn't know, so I didn't want to be rude.

One item that's come up again and again is the working group, which had been focused on making sure that some recommendations were made to the minister. Your organization put forward that you were supportive of the voluntary system. In fact, I have the letter here that you were a signatory to. It’s greatly appreciated. You also commented on the websites and other things available that others could feed into, the fact that there was a central focal point already.

However, later, for whatever reason, you decided to go against your words as stated here and you stated something different; you said you wanted a mandatory system.

Why is there the difference in the media? What was the cause for concern, and what are your concerns with regard to the change?

9:20 a.m.

Executive Director, Canadian Pharmacists Association

Dr. Jeff Poston

I don't think we've ever actually advocated for a mandatory system, but Jeff has been chairman of that working group, so I'm going to let him respond.

9:20 a.m.

Jeff Morrison Director, Government Relations and Public Affairs, Canadian Pharmacists Association

Thank you very much for the question, and yes, we're aware of that letter. In fact, I wrote that letter.

We've been supportive of the voluntary system really from the get-go. In fact, we put together that working group. We brought together the organizations that are signatories to the letter, so we've been advocating—

9:20 a.m.

Conservative

Kellie Leitch Conservative Simcoe—Grey, ON

Why the criticism in the media, then?

9:20 a.m.

Director, Government Relations and Public Affairs, Canadian Pharmacists Association

Jeff Morrison

What we've been talking about in the media, in particular—and I think we're referring to the role of Health Canada—are the items Dr. Poston spoke about in his presentation, which is what role Health Canada and the federal government can play in responding to shortages, not with respect to the reporting system.

As I say, we've been leading this working group that has been working towards a very robust voluntary system. We're still not there, but what we do think, and what Dr. Poston articulated, is that Health Canada needs to take on the proactive role that it took with respect to Sandoz. As Dr. Poston mentioned, that's a role we think Health Canada should have been playing before Sandoz and, more importantly, a role they should be playing moving forward.

9:20 a.m.

Conservative

Kellie Leitch Conservative Simcoe—Grey, ON

Then why is your attitude different in public than it is here in this room? I think we all are in this together. We want to take care of patients. I'm sure pharmacists do just as much as clinicians do, but why the difference in your presentation to the media and your aggressive attitude on that when we're all trying to be in this together?

9:20 a.m.

Executive Director, Canadian Pharmacists Association

Dr. Jeff Poston

I don't think.... I think there's perhaps been one media interview in which, as Jeff Morrison has explained, we talked about the importance of Health Canada's role. I think if you look at our press release and media statements in general, we've been pretty consistent in supporting a voluntary reporting system, but also, I think, pointing out that it if you look at the potential agencies and organizations out there that can play a role in affecting the situation, then clearly Health Canada has an important leadership role.

Believe me, drug shortages are not created by any one group or any one agency, and they're definitely not going to be solved by any one group or agency. I think it is very much a case that we are all in this together.

9:20 a.m.

Conservative

Kellie Leitch Conservative Simcoe—Grey, ON

To go back to Mrs. Davies' question, Dr. Lexchin, you did comment in your note about Connaught Labs. I think the impression with Mrs. Davies is that it was a federal government entity. Do you want to give a little elaboration on that? I know what Connaught Labs is. I think you know what Connaught Labs is. Just so people are clear on where that entity came from....

9:20 a.m.

Professor, School of Health Policy and Management, York University, As an Individual

Dr. Joel Lexchin

Okay. Connaught Labs—my history may be a little rusty—grew out of the University of Toronto after they discovered insulin, but it was taken over in the late 1970s, I think, by something called the Canada Development Corporation. It wasn't a federal department, but it was federally owned. I believe it operated something like Air Canada used to or CN used to when they were publicly owned.

At that point, in the early to mid-1980s, it was making insulin and vaccines. It subsequently was sold off to Sanofi Pasteur, so it no longer is a public company. In fact, it's been merged a few times.

9:20 a.m.

Conservative

Kellie Leitch Conservative Simcoe—Grey, ON

To be clear, Connaught Laboratories was actually generated because of Banting and Best. It was so that insulin could be commercialized. Its site is in northern Toronto so that it could prove that purpose. It was never a federal government entity, nor was it actually a provincial government entity; it was an entity of the University of Toronto.

9:20 a.m.

NDP

Libby Davies NDP Vancouver East, BC

That's not what he just said.

9:20 a.m.

Conservative

Kellie Leitch Conservative Simcoe—Grey, ON

I can tell you, because I sat in Banting and Best's office and I know the history of it. It was not a federal government entity at any point in time, nor was it a provincial government entity. It was an entity of the University of Toronto—

9:20 a.m.

Professor, School of Health Policy and Management, York University, As an Individual

9:20 a.m.

Conservative

Kellie Leitch Conservative Simcoe—Grey, ON

—which is a publicly owned institution—

9:20 a.m.

Professor, School of Health Policy and Management, York University, As an Individual

Dr. Joel Lexchin

No; it was, in fact, owned by the Canada Development Corporation in the mid-1980s, but we can—