Evidence of meeting #9 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was drug.

A recording is available from Parliament.

On the agenda

MPs speaking

Also speaking

Meena Ballantyne  Assistant Deputy Minister, Health Products and Food Branch, Department of Health
David Lee  Director, Office of Patented Medicines and Liaison, Therapeutic Products Directorate, Department of Health
Chris Turner  Director General, Marketed Health Products Directorate, Department of Health
Michael Vandergrift  Director General, Policy, Planning and International Affairs Directorate, Department of Health
Diana Dowthwaite  Director General, Health Products and Food Branch Inspectorate, Department of Health

12:35 p.m.

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

Meena Ballantyne

The documents we've tabled today have really benefited from the Standing Committee on Health's report, in a number of areas. So in that 30 seconds I would say that the blueprint for renewal, the new action plan that is being tabled and proposed, has benefited from the work of this committee, and we're very grateful for that.

12:35 p.m.

Conservative

The Chair Conservative Joy Smith

Thank you, Ms. Ballantyne.

Mr. Temelkovski.

January 31st, 2008 / 12:35 p.m.

Liberal

Lui Temelkovski Liberal Oak Ridges—Markham, ON

Thank you very much, Madam Chair, and thank you to the presenters.

Crime Stoppers has a number to call; Neighbourhood Watch has a number to call; whistle-blowers and Pizza Pizza have numbers to call. Is there a number to call regarding adverse reactions?

12:35 p.m.

Director General, Marketed Health Products Directorate, Department of Health

Dr. Chris Turner

There is a toll-free phone and fax line, and soon there will be postage-free mail-ins. If they are Internet savvy, there is also an online reporting form.

12:35 p.m.

Liberal

Lui Temelkovski Liberal Oak Ridges—Markham, ON

Is it advertised outside of the regular partners, which are hospitals, doctors, pharmacists?

12:35 p.m.

Director General, Marketed Health Products Directorate, Department of Health

Dr. Chris Turner

It's widely advertised. MedEffect promotes it. MedEffect is linked through some 400 other sources, so there are those sorts of electronic outreaches. As well, it's advertised in various professional journals. And a lot of our consumer group partners also promote the access with their patient groups in their publications. So it's widely disseminated.

12:35 p.m.

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

Meena Ballantyne

Part of our proposed action plan is to get more and better information out to Canadians. We've been doing a lot of work with health care professionals and with the communities, but we're trying now to reach out to Canadians much, much more.

12:35 p.m.

Liberal

Lui Temelkovski Liberal Oak Ridges—Markham, ON

Doctors report adverse reactions to Health Canada directly, and they also report them to manufacturers. Dr. Lee mentioned that doctors are nudged to report them and that pharmaceutical companies have a pre- as well as post-plan for reporting of adverse reactions. Is that the best way to have adverse reactions reported, to the drug companies, which vet the information and then send it to you? Or is there a better model, maybe going to you directly?

12:35 p.m.

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

Meena Ballantyne

We're looking at the best way to get information about adverse events. For example, the manufacturers must report them--absolutely. That's mandatory. We're encouraging health care professionals and Canadians to report them. We're working with all our sources across the world to get data. With this new approach, we would try to get as much information as possible and attach it to the conditions of the licence so we could act if we needed to.

12:40 p.m.

Liberal

Lui Temelkovski Liberal Oak Ridges—Markham, ON

Can it be added to the doctors' licensing that they must report these? It becomes part of their training and part of their everyday job, that they have to. Some of the pharmacy people are telling me that due to privacy reasons, one Shoppers Drug Mart does not release information to the Shoppers Drug Mart next door, let alone to Health Canada or anybody else. I was also informed that one hospital does not even release information to another hospital unless they're comingled in one way or another.

12:40 p.m.

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

Meena Ballantyne

That's absolutely right. There are jurisdictional issues with attaching anything to the licences of health care professionals such as doctors or pharmacists. This is a practice of medicine and pharmacy that is under provincial and territorial jurisdiction. We've been having discussions with them, because I think everybody recognizes that we need to do something. What's the best approach? Where do we start? What's practical, given privacy concerns, given the state of information technology in terms of being able to share these? These are all barriers to moving forward fast on this issue.

12:40 p.m.

Liberal

Lui Temelkovski Liberal Oak Ridges—Markham, ON

I have one other question.

All provinces have a health card, and our seniors have a health card, which is a federal card, I believe. Their medication is being paid for through federal funds, I'm assuming, through the seniors' medical program.

12:40 p.m.

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

Meena Ballantyne

It's provincial.

12:40 p.m.

Conservative

The Chair Conservative Joy Smith

Mr. Temelkovski's time is up.

Is that your answer, Ms. Ballantyne? Is there anything else you would like to say?

12:40 p.m.

Liberal

Lui Temelkovski Liberal Oak Ridges—Markham, ON

That's fine.

12:40 p.m.

Conservative

The Chair Conservative Joy Smith

Thank you so much.

For just a moment, I would like to ask Ms. Dowthwaite a question. I know you've been listening very carefully, and there's just something I would like to ask.

Does Health Canada rely on HPFB inspectors only for post-market surveillance investigations, or are provincial or other inspectors used as well?

12:40 p.m.

Diana Dowthwaite Director General, Health Products and Food Branch Inspectorate, Department of Health

We primarily use our own inspectors, but we also have alliances, and we rely on information we get from coroners' offices, from the colleges of pharmacy that were talked about, and through our linkages with the RCMP and other regulatory authorities. We have 100 of our own inspectors across the country, and we rely on information we get to conduct those investigations and inspections.

12:40 p.m.

Conservative

The Chair Conservative Joy Smith

Could I ask what role the inspectorate plays with respect to improved post-market surveillance?

12:40 p.m.

Director General, Health Products and Food Branch Inspectorate, Department of Health

Diana Dowthwaite

As we talked about, as part of our inspection program, we go into different companies and verify that they have a system in place to do the adverse reaction reporting that's required. We also work with Chris's group. Remember we talked about signals? If a signal comes in and requires an investigation or an inspection, it moves to this side of the house, and then we come in, and we'll investigate or inspect the information and then decide if there's any compliance and enforcement action required as a result of that information.

12:40 p.m.

Conservative

The Chair Conservative Joy Smith

Thank you. You've been very helpful.

Ms. Davidson.

12:40 p.m.

Conservative

Patricia Davidson Conservative Sarnia—Lambton, ON

Thank you.

I want to go back to what powers the ministry has and what they don't. On page 5 of your presentation, you talk about the power to remove unsafe health products from the market, which is part of the legislative amendments you're looking at.

We've all heard about the warnings about drugs: you don't buy them; if you have any left in your cupboard, you take them back to the pharmacy or the doctor, and all these things. What happens to the product that might be remaining on the shelves? Who checks into that? Doesn't the Minister of Health now have the ability to recall a product?

12:40 p.m.

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

Meena Ballantyne

Surprisingly no, the Minister of Health does not have any legislative authority to recall a health product at this point in time. What has worked in the past is that it's usually been in a company's best interest to recall a health product when something goes wrong. We've had very good success in terms of having, for example, a compliant pharmaceutical industry that is able to pull its products off the market.

But we need to be able to act quickly. The Minister of Health should have the authority. Every other country has it. On the food side we have it, but on the health products side we do not. With the proposed amendments to the Food and Drugs Act that we're talking about, which would represent the first time in over 40 years that we would be proposing to move forward, we would seek the legislative authority to be able to do that.

In terms of answering your question about who goes and checks whether these things are still on the shelves, it is the job of the inspectorate to make sure that any action we've taken is carried out. They would go out and make sure that's done.

We've been very proactive on the inspectorate side. For instance, we just did a customs blitz in a variety of centres across the country to see what was coming in. Maybe Diana could expand on that a bit.

12:45 p.m.

Director General, Health Products and Food Branch Inspectorate, Department of Health

Diana Dowthwaite

We did a customs blitz on the mail centres, just so we could have some statistical data on what kinds of parcels and drugs are coming across the border, and we're calculating that data right now, so I can't give you any information on that. But to follow up on Meena's point, it is a voluntary compliance, and the majority of the time the companies are complying. It's in their best interest to comply, and we do it as a compliance verification to make sure they've done the recall properly and that the product has been taken off the shelves.

12:45 p.m.

Conservative

Patricia Davidson Conservative Sarnia—Lambton, ON

Thank you.

12:45 p.m.

Conservative

The Chair Conservative Joy Smith

We have four speakers, and Mr. Thibault would also like to ask a question. We're going to run out of time, because we only have about 14 more minutes left, so I'm just going to make members aware of that. We'll go on to Madame Gagnon right now. So perhaps you could be considerate of each other, to allow Mr. Thibault time to intervene.

Madame Gagnon.