Health Committee on Feb. 12th, 2009

[The Chair, Conservative, Joy Smith]

Good afternoon, ladies and gentlemen. I welcome you to the health committee, the most exciting committee on the Hill, I have to tell you.

We are so pleased that you could make it today, because there are some very astute people around this committee table who are very anxious to ask you some questions.

Before we start, I would just like to ask the committee if we could suspend the committee at 5:15 today to deal with some business. Could I have a show of hands? Is that okay with everybody, at 5:15?

[Some hon. members]

Agreed.

[The Chair, Conservative, Joy Smith]

Thank you. So at 5:15 today we're going to suspend the meeting and deal with some committee business that has to be attended to.

I would also like to remind members to please submit your lists of subjects that you would like the committee to study to the clerk by Wednesday, February 18. Just forward it to the clerk's office, and they will bring all of the lists back to committee.

Today, pursuant to Standing Order 108(2) and our study of the departmental expenditure plans for Health Canada and related agencies, I would very much like to welcome the members of Assisted Human Reproduction Canada: Beth Pieterson, the executive director; and Elinor Wilson, president and chief executive officer.

We have representatives from the Canadian Institutes of Health Research: James Roberge, chief financial officer; and Pierre Chartrand, vice-president of research. We welcome you.

We also have, from the Patented Medicine Prices Review Board, Brien Benoit, the chairperson; and Barbara Ouellet, the executive director. Welcome to you as well.

And we have members from the Hazardous Materials Information Review Commission: Mary Hill, assistant vice-president, corporate services and adjudication branch; and Sharon Watts, president and chief executive officer. Welcome.

We are more than privileged to have you very learned people here today to really add to our committee.

We will start the questioning now with Dr. Bennett, for a seven-minute round.

[Carolyn Bennett, Liberal, St. Paul's, ON]

Thanks very much, and thanks to all of you for coming.

I guess I wanted to start by saying that in looking at the estimates again, it seems that things that should have gone to Health Canada have gone to pay for ministers of state in every other department. So it must be bit annoying to some of you who needed some money that you didn't get it, that it instead went to pay for ministers of state in every other department.

Maybe we'll start with the agency that seems to have a lot of trouble getting money out the door, Assisted Human Reproduction Canada. We continue to be unable to get you going, it seems. I'm not quite sure why the $75 million went to CIHR.

Dr. Wilson, although the minister tried to explain why we still haven't seen the regulations, how are you functioning without a law or any regulations, and how do you spend any money at all, seeing that you don't really exist?

[Dr. Elinor Wilson, President and Chief Executive Officer, Assisted Human Reproduction Canada]

Thank you very much for the question, Dr. Bennett.

In terms of the amounts of money that we are spending, as you are aware, the agency actually opened its doors two years ago this February 14. During that time, we have been working in two major areas.

The first major area, obviously, has been to establish the infrastructure in order for us to do our work. When the agency opened, it had one employee—me—and there was no block transfer of staff, so we had to bring staff in.

We have to create the systems, for example, for the personal health information registry. We have to create the systems for the computerized issuing of licences. We have to create all of the things so that once the regulations are passed, we are ready to be out the door within a very short period of time in order to do the work.

Obviously, we are also working—

[Carolyn Bennett, Liberal, St. Paul's, ON]

I just want to know how you can do that when you don't know what's going to be in the regulations? How do you know you'll be in compliance with the regulations before the regulations have even been passed? This committee has only seen chapter 8.

[Dr. Elinor Wilson]

Thank you.

We do know, according to the act, that we will be issuing licences and we know that we will need to have a system and materials developed in order for people to apply for licences. So, gradually, as we're working through that.... Without the regulations, you can automatically assume that there are certain things you're going to want to ask of the community in terms of their applying for a licence—certain common information that everyone is going to have to have. But the most important part is starting to build those systems so that we can have a complete system ready to go, an automated or virtual system whereby people can apply via computer, etc., so that it's not burdensome to the community.

The second major area in terms of this is outreach. It's really necessary to learn the business of the community that will regulated, to learn what they are doing, and to start to build those relationships, both with patient organizations who will have a very important role to play in this and with organizations such as the Canadian Fertility and Andrology Society, the Society of Obstetricians and Gynaecologists of Canada, and the Canadian family physicians, many of whom—especially the family physicians—were not necessarily aware that some of their activities would be covered by the regulations.

So we've done some survey work with them to find out the practices in the field for both family physicians and gynaecologists, and we have been doing a lot of outreach.

[Carolyn Bennett, Liberal, St. Paul's, ON]

And regarding the $75 million that's going to CIHR, is it normal to be sending money back and forth among organizations?

[Dr. Elinor Wilson]

It's $75,000, Dr. Bennett.

[Carolyn Bennett, Liberal, St. Paul's, ON]

Okay.

[Dr. Elinor Wilson]

The rationale for this, first of all, is that as an agency who will be regulating in these highly scientific areas, it's vital that we have a very strong evidence base on which to base things.

We knew that CIHR has just finished funding, over the last several years, a healthy embryo research project, and this was an opportunity for us to perhaps provide some funding to ensure that the information from that project would be translated to the appropriate stakeholders so that it could be utilized.

[Carolyn Bennett, Liberal, St. Paul's, ON]

Okay.

I had a quick question for the PMPRB. The Institute on Governance report showed there was a bit of mandate creep, in that you were operating outside of the original mandate set up in the Patent Act. So I am just wondering how you would respond to such a criticism when you've asked for such a massive increase in funds.

[Dr. Brien Benoit, Chairperson, Patented Medicine Prices Review Board]

Well, Dr. Bennett, if I could ask the question back, has that Institute on Governance report been distributed to the members of this committee? I ask because we were provided with this report in September of last year.

The document that we received is dated April of 2008 and is marked as confidential, and we were assured by Rx&D, the organization that mandated this report, that we would be permitted, if the report were to be made public, to respond to some of the questions, one of which you're presenting today.

The issue of mandate creep is something that is easy to throw out there, but our mandate has not changed: we operate under the Patent Act and we have regulations. The Patent Act has not been changed since 1993; our regulations have not been changed since 1994.

Now, we have a dual mandate. We have both a reporting role and a regulatory role. If you didn't like the regulatory role, you would say that our mandate is mostly reporting; but we do have a double mandate, and one doesn't take precedence over the other. The Patent Act clearly gives us a mandate to regulate the prices of patented medicines.

[Carolyn Bennett, Liberal, St. Paul's, ON]

So between the spring and the fall there's a lot of money—

[The Chair, Conservative, Joy Smith]

Thank you, Mr. Benoit.

Monsieur Malo, you are next.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

I will pursue Ms. Bennett's line of questioning . It is very interesting to delve further into this issue.

You will agree with me that an additional $4.7 million for a budget that was previously $5.5 million is quite a top-up. It is practically double the original amount.

Why, over the course of the year, did you need to practically double your budget?

[Dr. Brien Benoit]

Mr. Malo, our budget was increased by 80%. You are right in saying that it has almost doubled. However, one must remember that our workload practically doubled as well, and we were not responsible for that. This is a result of the fact that more patented drugs were introduced into the Canadian market and we had to conduct investigations to determine if prices were consistent with our guidelines. Therefore, we were not the ones responsible for creating the work. The pharmaceutical industry introduced more products into Canada.

In fact, we are now able to amend our guidelines. This project began more than three years ago, and we hope to complete it by June of this year. Things are taking longer because of the high number of consultations we have to carry out with people involved in the issue. All of this creates more work for us.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Does your mandate not cover mainly regulations and monitoring so as to ensure that patented drugs are not sold at excessive prices?

[Dr. Brien Benoit]

Indeed, our mandate is focused on excessive pricing. To determine whether or not a price is excessive, all of the issues surrounding a particular product must be examined. We have a very complex comparative analysis system for drugs that are used to treat the same disease. This allows us to determine what their prices are, etc.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Do you also review the discounts offered by manufacturers? Doesn’t this fall slightly outside your mandate?

[Dr. Brien Benoit]

The Patent Act clearly stipulates that we are to review net prices, or, to be more precise, discounted prices, etc. We are currently holding consultations with both provincial and industry representatives to identify and assess these rebates.

Certain pharmaceutical companies seek to postpone their discounts because this reduces their average prices; on the other hand, there are many others, perhaps even the majority, that do not. It's an example of the push-pull concept.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Do you not think that this is interfering with areas that fall under Quebec and provincial jurisdiction? The provinces are essentially the buyers and it is they who are in charge of regulating this issue.

[Dr. Brien Benoit]

We act in full compliance with the Patent Act, a federal statute. We fully recognize that health care falls within provincial jurisdiction, but we are acting under the Patent Act. Our mandate is a federal one.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

So if I understand correctly, you adjust your mandate according to what you want your team to do; at least that’s what it seems like.

[Dr. Brien Benoit]

No, I wouldn’t say that. We comply with rather stringent regulations that have not been amended for 15 years because they work rather well. We are often called before the courts by pharmaceutical companies that don’t like the decisions we hand down during our hearings, or for other reasons.