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

9:55 a.m.

NDP

Djaouida Sellah Saint-Bruno—Saint-Hubert, QC

I want to start by thanking the witnesses for their informative remarks.

What worries me, as a medical practitioner, is of course the drug shortage. I do not know what I would say to a patient who came to me and whose critical drug was out of stock.

According to the Canadian Agency for Drugs and Technologies in Health, new Health Canada requirements, such as the policy for notifiable changes, have contributed to drug shortages.

Could you describe the new notifiable change policy to the committee? Do you agree that new requirements by your department can contribute to drug shortages, and why?

10 a.m.

Assistant Deputy Minister, Health Products and Food Branch, Department of Health

Paul Glover

Thank you, Madam Chair.

At no time do we believe that Health Canada, through any of our policies or actions, contributed to a drug shortage. Through a matter of policy, there are always drugs in our queue waiting for approval. When we understand that a drug is medically necessary and is of priority to the health system, we can expedite the review process. That's something we do and have continued to do, whether drugs are in shortage or not. We give priority to new, innovative therapies, rather than approving a second or third me-too drug, if you will, and we continue to do that.

We have, through investments in the program, significantly improved our performance. We are meeting all of our performance targets, with the exception of generic drugs. In all instances, as we approve drugs, we do so with the full intent of making sure that they are brought to the market as quickly and efficiently as possible; that is, we provide authorizations that the drugs are safe and of high quality. It is really up to the market to determine, once the authorizations are provided, if they will choose to purchase from that source that we have authorized.

We are, in fact, aware of a number of instances in which, after we have authorized a product, the market has chosen not to purchase from that, or potentially the authorization holder has decided not to enter the Canadian market, despite having gone through our approval process and paying us substantial fees to achieve our approval.

It is difficult for me to say exactly why these drug shortages happen, since we do authorize numerous sources of supply.

10 a.m.

NDP

Dany Morin Chicoutimi—Le Fjord, QC

We still have one minute and a half, so I'm going to continue.

I'm going to follow up on my question that I asked you earlier. You said that you would prefer to let the suppliers and the providers arrange things among themselves and provide a solution. Health Canada does monitor the drug shortages that will come or that could happen down the road, right?

10 a.m.

Assistant Deputy Minister, Health Products and Food Branch, Department of Health

Paul Glover

Mr. Chair, we do not have a legislative or regulatory responsibility with respect to drug shortages. We continue to play a role when asked by provinces and jurisdictions.

If I may—I know your time is limited—we have the two public websites up and running right now. There are about 200 drugs that the pharmaceutical companies have posted on those websites that the health system is dealing with and that are in limited supply, so they're making alternate purchasing arrangements, they're changing their therapeutic approaches, and they have not asked for federal intervention. They're dealing with those at a very localized level—

10 a.m.

NDP

Dany Morin Chicoutimi—Le Fjord, QC

I don't want to cut you off, but I want to finish by saying that pretty much all the witnesses want Health Canada to be proactive in monitoring the current drug shortages.

10 a.m.

Conservative

The Chair Joy Smith

Thank you, Dr. Morin.

We'll now go to Dr. Carrie and Mr. Brown.

Who would like to begin? You're sharing your time, so I'll tell you when you are about halfway through.

10 a.m.

Conservative

Patrick Brown Barrie, ON

Thank you, Madam Chair.

I understand that our Minister of Health had been working aggressively behind the scenes to manage the transparency of drug shortages well before the situation at Sandoz arrived. I understand she's been in close touch with industry and has written several letters.

Could you enlighten this committee, in a chronological order, on what our Minister of Health has been doing on that front?

10 a.m.

Assistant Deputy Minister, Health Products and Food Branch, Department of Health

Paul Glover

Thank you, Madam Chair, for the member's question.

The Minister of Health did become quite concerned over a year ago about the global problem of the increasing number of shortages that were being experienced worldwide, not just in Canada but as a global problem.

She wrote to the various industry associations, including Rx&D in terms of the brand names, CGPA for the generics, the biotech industry, the Canadian Medical Association, the Pharmacists Association, the distributors, the wholesalers, and others. She asked them to work together, first to improve transparency, so that if there were drug shortages, there would be a way to notify the health systems so that they could respond, and second to take a look at what they could do in reducing the number of drug shortages that were occurring.

In response to her recommendation, a working group was formed. They began as a collective to address this issue. They wrote back to the minister with a plan that had three phases. The first phase, which is already up and operational, involves the existing websites, the ones that exist today, where industry is now posting drug shortage information and making that available to any and all Canadians in the health jurisdictions. There are two existing websites.

Our response was while that was a positive first step, it was not sufficient; there needed to be a one-stop site where all health system practitioners, professionals, provinces, and Canadians in general could go to get information on drug shortages. That's the second phase, which is being accelerated right now. The two main industry associations have put money on the table to build this second phase.

That will be a positive step. That new site should have increased functionality, and not just with regard to what drugs are in shortage. It will address the previous member's question with regard to how to deal with a shortage of a particular drug, what alternatives can be used to treat a patient, and other information that might help health system practitioners deal with shortages.

The other thing—

10:05 a.m.

Conservative

The Chair Joy Smith

You've got a few more minutes. In order to share time, we're going to have to be mindful of that.

10:05 a.m.

Assistant Deputy Minister, Health Products and Food Branch, Department of Health

Paul Glover

The minister also recently wrote to the associations to express her concern that their members weren't using the sites for reporting and were actually posting drug shortages on their own websites. The minister has since received written commitment from all the members of the industry associations that they will now begin using those websites and, in fact, we have seen a spike in the amount of reporting to the public websites accordingly.

April 3rd, 2012 / 10:05 a.m.

Conservative

Colin Carrie Oshawa, ON

Thank you. I'll be quick.

I wanted to ask you a question on jurisdiction. Most patients don't understand it, but we all have to operate within it—the professionals, the governments—regardless of how frustrating it can be at times. We actually invited the provinces to be here, but they declined to be in front of us. Even national organizations have been in front of us, and my colleague said that they're asking us to intervene. There does not seem to be an understanding that the federal government can't grab provincial jurisdiction from the provinces just because national organizations or opposition parties say we should be doing that.

Could you take a moment now and go over jurisdictions with this type of issue and define what the federal roles are, what the provincial roles are, and if you have time, how the professions that are actually on the ground can get that information up through the system?

10:05 a.m.

Assistant Deputy Minister, Health Products and Food Branch, Department of Health

Paul Glover

Thank you, Madam Chair.

Very briefly, the provinces are responsible for the delivery of health services. The federal role and the role that we play is in the approval of the drugs. Are they safe? Do they do what they say they do? Are they made with quality, so that every pill that a person takes is the same pill and has the same medication in it? That is our federal role.

The other thing that we do—not through my organization, but under the federal Patent Act, through the PMPRB, the Patented Medicine Prices Review Board—is monitor pricing. If there is a view that prices of some of the patent drugs are exorbitant, then they can come in and set a maximum. That is the federal role with respect to this area.

Provinces then deliver the health services. In addition, they create formularies for what drugs they will choose to pay for in their population for seniors, for people on social assistance, etc. They make decisions about what they do and don't want to list on their formularies. The only exception is if a drug is provided in a hospital setting, it is provided. If that same drug is provided outside a hospital, it would be a provincial decision as to whether it was part of their formulary or not. In a nutshell, those are the main roles and responsibilities.

The final piece is the colleges and the role that they play in training their health professionals to use these drugs. There is what we call “off-label use”. Health Canada will approve a drug based on what the company says is the indication that they're looking for, and we will put that information to prescribers on the label. However, the college then trains physicians who can say, “That's great; that's what the indication is for, but we would also like to use this drug for other indications.” That's called off-label use. It is completely legal and allowed, and it is within their jurisdiction as well.

10:10 a.m.

Conservative

Colin Carrie Oshawa, ON

Do I have any time?

10:10 a.m.

Conservative

The Chair Joy Smith

You have almost a minute.

10:10 a.m.

Conservative

Colin Carrie Oshawa, ON

In your speech and presentation, you said: In addition, reporting obligations can be made formally binding if drug purchasers, on behalf of provincial and territorial clients, embed this reporting obligation in their supply contracts, as well as a requirement that suppliers have contingency plans in place in the event they are unable to fill orders.

In other words, that's totally between two people or two organizations. They can put that in their contracts.

Are you aware if they do that, or does anybody do that today?