Health Committee on April 3rd, 2012

[Colin Carrie, Conservative, 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?

[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.

[Colin Carrie, Conservative, Oshawa, ON]

Do I have any time?

[The Chair, Conservative, Joy Smith]

You have almost a minute.

[Colin Carrie, Conservative, 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?

[Paul Glover]

Madam Chair, as we heard at committee, in Canada HealthPRO, one of the main large bulk purchasers, is introducing that very policy in their supply contracts. We think that's a very positive development.

We are aware that in other jurisdictions—again, not at the government level, but between the suppliers and purchasers—those contracts do contain those clauses, and they have been successful in helping to limit the number of drug shortages.

My main point would be that having that intervention as close as possible to the two parties that are able to adjudicate the problem seems to be the most effective.

[The Chair, Conservative, Joy Smith]

Thank you, Mr. Glover.

Dr. Fry is next.

[Hedy Fry, Liberal, Vancouver Centre, BC]

Thank you very much for your presentation, Mr. Glover, Ms. Mullin, and Ms. Sabourin.

In countries that have dealt successfully with this drug shortage, such as New Zealand and the United States, they do a couple of important things: they identify the drugs that are going to be short, they anticipate, and they manage.

Now given that you, as a federal government, are responsible for regulation and approval, you have a huge role to play in identifying and managing and fast-forwarding areas where you think there's going to be a shortage and in other areas involving manufacturing the drugs, etc. There is a role.

We heard from many people who presented here that the Food and Drug Administration has been very successful in using their mandate to predict, identify, and manage shortages. First and foremost, patients need medication when they need medication. Many patients who don't get that medication could die or could be severely impaired for the rest of their lives.

When we start talking about whose jurisdiction is what, it becomes moot. It isn't really about who you pick up the phone and call; it is about whether the patient gets the drug and gets to be well. At the end of the day, I think the responsibility rests with the people who regulate the drugs and who are able to work with others—as I would like to say, a leader—to try to find a way around this problem. It's about human beings. It's about Canadians. It's about protecting them and caring for them.

We're trying to find a resolution here. It's not a case of fault or blame. Could we put that aside for a minute?

In November 2011 the Food and Drug Administration told Sandoz that they did not comply with manufacturing standards. Was your department aware of that in November 2011? Were you aware then of what that impact could be on real people? I hope you didn't know. If you had, I would have thought you would have felt it was a moral obligation to warn people that this was going to happen, so that doctors, anesthetists, pharmacists, hospitals, etc. could start stockpiling.

Were you aware of the November 2011 FDA ruling? If you were, did you tell people? Did you warn them? If you didn't, why not? That's my first question.

Second, I continue to hear the federal government saying that they are just regulators and approvers, but you're the fifth-largest deliverer of health care in this country, so you're not just regulators and approval parties. You actually deliver services to the armed forces, the Inuit, the first nations, etc., so you need to know how these people you deliver services to are going to be able to get their medications and be able to get help.

Can you give me an answer about your knowledge of Sandoz and about thinking a federal leadership role is required, first in delivering care to the people you need to and second in terms of coming together and working with the provinces to make sure Canadians get drugs?

[Paul Glover]

First and foremost, we agree that patients need to come first. We absolutely understand and respect that, and that's why we're doing our part in this time of crisis. We are not hiding behind our role, our jurisdiction, and we have taken extraordinary measures to expedite review processes to approve drugs through the special access program. However, as the member pointed out, all parties need to step up and do their part if we're going to be able to deal with these shortages. We continue to believe that we play a unique role, as do other parts of the health system, and we must all step up equally to respond to this challenge.

With respect to the November warning letter that was issued by the FDA, there are a couple of elements that are important for the committee to clearly understand. The FDA issued its warning letter. That was made publicly available. We saw it on the FDA's website in December. That was a warning letter. There was a deficiency, and it asked Sandoz to respond to that deficiency. It did not close the plant. It was not specific to Sandoz Boucherville; there are two sites in the U.S. It was a warning letter that did reference Sandoz but also included other sites in the United States.

It's also important to note that Health Canada had been in and inspected the Sandoz plant. As with the FDA, we had observations with respect to our inspection and had written to the company asking them to follow up with us as well. At no point were we aware that there would be a shortage, the crisis that we are facing today.

We followed up with Sandoz through the months of November, December, and January to understand how they would be responding to both our observations as a regulator in Canada and in regard to what they would be doing in response to the FDA. We were not fully aware of the full extent to which Sandoz would be dealing with this until they publicly wrote to all of their clients.

[Hedy Fry, Liberal, Vancouver Centre, BC]

Excuse me, Mr. Glover. I just wanted to ask you if you have learned any lessons. Do you now think that the next time you see the FDA issuing a warning to anyone, you might think it could lead to this? Would you do what everyone is hoping the federal government would take leadership in, which is to identify, anticipate, and manage, as the FDA is currently doing, with regard to drug shortages?

I think this is what we're talking about here, taking some kind of responsibility. There was no legal obligation for you to notify anybody, but there was a moral obligation.

[The Chair, Conservative, Joy Smith]

Time is just about up if you want Mr. Glover to answer your question, Dr. Fry.

Go ahead, Mr. Glover.

[Paul Glover]

We are in regular contact, Madam Chair, with the FDA, and their approach is very similar to the Canadian approach. They require companies to notify them. When they are notified, they take steps similar to what we've been doing through this emergency, which is expediting review. They reach out to foreign jurisdictions; I personally wrote to the EMA, FDA, and other jurisdictions seeking alternate supply, etc.,

When shortages are brought to our attention, absolutely, we will continue to respond with the best interests of patients first and foremost in our mind.

[The Chair, Conservative, Joy Smith]

Thank you very much.

We'll now go to Ms. Block and Mr. Lizon.

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

Go ahead, Ms. Block.

[Kelly Block, Conservative, Saskatoon—Rosetown—Biggar, SK]

Thank you very much, Madam Chair.

I would like to thank the representatives from Health Canada for joining us today. You mentioned that there was an earlier panel, and their presentations were very informative as well.

I want to go to a comment that you made, Mr. Glover, in your opening remarks. You said, “I would just like to reaffirm for the committee that Health Canada will continue to play its part”, and that was close to the end of your comments. We know that when there is a critical incident, such as the most recent drug shortage, it's important for everyone to understand what their role is, to play their part in addressing it in the short term, and then to work together to ensure that the issue is addressed in the long term.

In the previous panel, Mr. O'Rourke spoke of an expanded role for his organization as a sort of clearinghouse of information. In your opening remarks I believe you said you are aware of the expanded role that the Canadian Agency for Drugs and Technologies in Health is perhaps hoping to play when it comes to drug shortages. I'm just wondering if you would be willing to comment a little bit about what your understanding is around that role and what your thoughts are on it.

[Paul Glover]

Thank you for the question.

We've spent a lot of time today talking about the things we have done in response to this crisis, including the special access program and the expediting of reviews and approvals. They were in response to the crisis.

We would like to take action to help the entire system better manage, and in fact prevent, crises as we move forward, so we will continue to push very hard for that one-stop site and will require the drug companies to post the information to that site for the benefit of all. It would be for my agency so that we can do our part. It would be for the provinces and territories so that they can do their part in planning for these shortages and can mitigate them. It would be for bulk purchasers, who could look at their supply and what's happening and respond accordingly. Finally, it would be for local practitioners, so that they can be aware that if they have patients who need those medications, they may need to come up with alternative treatment plans and know what substitutes are available to them. That website will be critical, in the longer term, to being able to do those things.

While we're very pleased that the drug companies have come forward and have said that they're committed to that site, we frankly don't want the drug companies running that site. We think it's beneficial that the site be run by a neutral third party. We believe that a group like CADTH would be ideally positioned. We're in contact with the provinces and territories to explore feasibility and whether there's unanimous agreement that it would be the best place to house this kind of information clearinghouse.

That would also position CADTH to play a unique role in terms of the expertise it has in alternate therapies and in gathering best practices they're already aware of within the health system and distributing them to all the players.

We will continue to push for the requirement, as per the motion that was debated and passed in the House. We will push to make sure that we have this one-stop site up and available, not just for Health Canada—we have our role to play—but for all levels of the health care system, so that they can take the appropriate action to respond.

I know that this is a long answer. I apologize to the member.

Finally, we will continue to encourage and have dialogue with other jurisdictions about what's working in the attempt to adopt best practices. We firmly believe, as this committee has heard, in some of the practices in place in other jurisdictions, in particular those that have clauses in the supply arrangements that first and foremost diversify supply. Sole-source arrangements are dangerous. We've seen that in the past and we continue to believe that this is the case.

We understand that moving to diversify supply has an impact on price, so we'll continue to work with the provinces and territories to make sure that we have best practices for distribution, diversification of supply, pricing arrangements, and other things. We will offer any support and assistance we can to encourage them to do that.

[The Chair, Conservative, Joy Smith]

Go ahead, Mr. Lizon.

[Wladyslaw Lizon, Conservative, Mississauga East—Cooksville, ON]

Thank you very much, Madam Chair. Thank you, witnesses, for coming here this morning.

Madam Chair, on page 3 of Mr. Glover's presentation, it states that Health Canada approved 50 requests for emergency access to needed drugs through a special access program. I would ask if he can maybe share more information on how the special access program works and how this helps during a drug shortage.

I will ask my second question right now, and then if I have more time, maybe I will ask one short additional question.

During our meetings and in our study, we've heard a lot about the factors that contribute to drug shortages. Among them, single-sourcing is one of the main ones, I believe. Of course, there are recommendations related to the website and on whether it should be mandatory to identify drug shortages.

Even if you know about possible drug shortages, and you have that information, how do you apply it? What do you do in the situation? What recommendations would you have for bulk purchasers, provinces, and territories in situations that are beyond human control? There could be a natural disaster somewhere that disrupts production; these are beyond any mandatory reporting on possible drug shortages.

Can you address both questions, please?

[Paul Glover]

With respect to the first question, I'll turn to Barb Sabourin on the special access program.

However, I'll start by answering the second question. We believe, looking at and learning from all the lessons that we have been through, that information is critical in the event of any drug shortage. A particular drug may be in shortage and there will be alternate therapies available, which means that it's very simple for the health system to adjust. They may prefer drug X, but drug Y may be equally effective, and it's simply a matter of making the adjustments.

For some patients, drug Y may not work; the physician may have already tried it, and they'll have to look to other arrangements. It is definitely a practice of medicine issue that is case by case between the physicians and their patients, but guidance about what those alternatives are is first and foremost a health—

[The Chair, Conservative, Joy Smith]

I'm sorry, Mr. Glover, but we've gone over time. I'm sorry about that.

We're just about to the end. We have about three minutes.

Ms. Davies, do you want to take three minutes? We're going to suspend for a business meeting. Would you like to go into the second round?

[Libby Davies, NDP, Vancouver East, BC]

Don't we actually go to 10:30, so it looks like five minutes?

[The Chair, Conservative, Joy Smith]

Just ask your question, Ms. Davies. I need to suspend before 10:30.

Do you want to go into the business meeting, and I'll suspend after 10:30?

[Libby Davies, NDP, Vancouver East, BC]

No, but there is a big difference between three minutes and five minutes when time is tight. I can see the clock; we have actually five and a half minutes until 10:30. We go in camera maybe 30 seconds before that.

[The Chair, Conservative, Joy Smith]

Well, then, what we'll do is cut into the business meeting.

[Libby Davies, NDP, Vancouver East, BC]

First of all, Mr. Glover, thank you for being here today. I'm glad to hear that Health Canada is making it clear that you do support public reporting and that it be a requirement, as you noted in your brief today.

The huge issue that we're missing is the lack of any oversight. We hear a lot of information about different roles and who does what, whether it's provinces or the purchasers, but there has been a lack of oversight and leadership.

We had some suggestions today. It's unfortunate that you didn't hear the earlier presentations, but the one in particular that my colleague referred to was a suggestion that Health Canada should convene an expert committee to look at the off-patent drugs that are considered critical and are supplied by only one or two companies. Never mind if they are short or not; it would be just to have an inventory of the drugs that are very well used and are supplied by only one or two suppliers. Following that, possible alternative sources could be identified through Health Canada with this expert committee, so that other arrangements could be made if there were an emergency. That, to me, is very much based on public interest and public health interest, which is part of your mandate as well as that of PHAC.

I wonder if you could respond to that.

As well, we know that the Auditor General has said that Health Canada has been slow to approve alternate suppliers. This has also been part of the problem. I know that right now we're under an expedited process, but how long will that continue? I think the Auditor General did make that a very clear issue in terms of the approval process itself.

[Paul Glover]

Given we're very short on time, I'll be as brief as possible. I apologize if—