Evidence of meeting #36 for Health in the 41st Parliament, 1st 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

  • Jim Keon  President, Canadian Generic Pharmaceutical Association
  • Russell Williams  President, Canada's Research-Based Pharmaceutical Companies (Rx & D)
  • David Johnston  President and Chief Executive Officer, Canadian Association for Pharmacy Distribution Management
  • Kathleen Boyle  Vice-President, Services, HealthPRO Procurement Services Inc.
  • Michel Robidoux  President, Sandoz Canada, Canadian Generic Pharmaceutical Association
  • Mark Ferdinand  Senior Director, Health and Economic Policy, Canada's Research-Based Pharmaceutical Companies (Rx & D)
  • Michael Blanchard  Clinical Director, Pharmacy Services, HealthPRO Procurement Services Inc.
  • Jeremy Desai  President and Chief Operating Officer, Apotex Inc., Canadian Generic Pharmaceutical Association

10:15 a.m.

Conservative

The Chair Joy Smith

Just 30 seconds, I'm sorry.

10:15 a.m.

Vice-President, Services, HealthPRO Procurement Services Inc.

Kathleen Boyle

The control we have is that going forward we will be awarding to more than one supplier where there is more than one supplier available in the market. Further than that, I believe it's the role of government if there needs to be regulation to control the exiting of suppliers from the marketplace.

10:15 a.m.

Conservative

Wladyslaw Lizon Mississauga East—Cooksville, ON

Isn't your—

10:15 a.m.

Conservative

The Chair Joy Smith

I'm sorry, Mr. Lizon, your time is up.

Dr. Sellah.

10:15 a.m.

NDP

Djaouida Sellah Saint-Bruno—Saint-Hubert, QC

Thank you, Madam Chair.

Thank you to all the witnesses who are here.

In my eyes, as a doctor, it is clear that we have a very significant problem. I have two questions and the witnesses should feel free to respond to them.

First of all, why was it the FDA that raised the alarm bells regarding these facilities that don't meet health criteria? Are American standards more exacting, stricter than Canadian standards?

Secondly, let's look at the situation in other countries. We know that the United States has a law, referred to as the Preserving Access to Life-Saving Medications Act, which compels drug manufacturers to inform, without delay, the FDA of any incidents that could cause a drug shortage, once the decision has been made to cap or halt the production of drugs. In New Zealand, pharmaceutical manufacturers have a contractual obligation to inform the Pharmaceutical Management Agency of New Zealand, which is an independent crown corporation reporting to the Department of Health, when stocks fall below the two-month supply level or they become aware of a possible shortage.

Do you believe that Canada should intervene in a similar fashion? What would be the impact of such a law on our system? Instead of having a voluntary reporting system, do you not think that we should have a mandatory reporting system here in Canada?

Thank you.

10:20 a.m.

Conservative

The Chair Joy Smith

Who's going to take that one?

Mr. Desai.

March 27th, 2012 / 10:20 a.m.

Dr. Jeremy Desai President and Chief Operating Officer, Apotex Inc., Canadian Generic Pharmaceutical Association

Good morning, Madam Chair and honourable members.

I'll answer the first question regarding the FDA. I think it's important to understand that there are no differing standards amongst what I would call the tier 1 regulators, whether it's the FDA, Health Canada, the European Union, or Australia, to name some of those.

What really happened, what triggered FDA's increased enforceability, and I think it may have been mentioned earlier on, resulted from the heparin contamination from a Chinese source that resulted in several deaths in the U.S., and very rapidly there was contaminated melamine in milk that also came from China. That coincided with the appointment of a new commissioner of the FDA, Dr. Margaret Hamburg. One of her first public speeches talked about increased enforceability to drug manufacturers, both branded manufacturers and generic manufacturers. That increased enforceability has really resulted in either mandated action imposed by the FDA as a result of warning letters and other instruments that are available to them, or voluntary action taken by the manufacturers to ensure that the products they are putting on the marketplace will meet the stricter enforceability compliance guidelines that the FDA imposed and other regulatory agencies followed thereafter. The standard did not change.

10:20 a.m.

Conservative

The Chair Joy Smith

You have time.

10:20 a.m.

NDP

Djaouida Sellah Saint-Bruno—Saint-Hubert, QC

Yes, that is right.

As for my second question...

10:20 a.m.

Conservative

The Chair Joy Smith

Yes, go ahead.

10:20 a.m.

NDP

Djaouida Sellah Saint-Bruno—Saint-Hubert, QC

...you have somewhat answered my concern, but I am still asking myself questions about the fact that it is an American and not a Canadian institution that is doing the monitoring. I would also like someone to answer my question about a mandatory system versus a voluntary reporting system.

10:20 a.m.

President, Canadian Generic Pharmaceutical Association

Jim Keon

We are currently reporting on a voluntary basis because there are no regulations. As we have already explained, our companies are doing everything possible to report on current and future shortages. We are therefore working with all of the stakeholders in the sector and in cooperation with Health Canada, and we are prepared to continue doing this. Should the system become mandatory, we will comply, but we do think that our voluntary reporting system is good.

10:20 a.m.

NDP

Djaouida Sellah Saint-Bruno—Saint-Hubert, QC

Could Mrs. Boyle answer my question?

10:20 a.m.

Conservative

The Chair Joy Smith

Thank you.

10:20 a.m.

NDP

Djaouida Sellah Saint-Bruno—Saint-Hubert, QC

She was saying that, among...