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 market.

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

9:30 a.m.

President, Canadian Generic Pharmaceutical Association

Jim Keon

With regard to marketplace issues, I think we were referring to marketplace issues in Canada and internationally. Some of the speakers have mentioned that for some of these older products, there's a diminishing number of suppliers, and that is true. There has been rationalization internationally, and the reality is as—

9:30 a.m.

NDP

Libby Davies Vancouver East, BC

Excuse me. What do you mean by rationalization internationally?

9:30 a.m.

President, Canadian Generic Pharmaceutical Association

Jim Keon

There are fewer.

9:30 a.m.

NDP

Libby Davies Vancouver East, BC

Could you just answer us sort of straightforwardly?

9:30 a.m.

President, Canadian Generic Pharmaceutical Association

Jim Keon

Prices have been going down worldwide for some of these products, and therefore there are fewer companies that can commercially exist making those products.

9:30 a.m.

NDP

Libby Davies Vancouver East, BC

Is there a change, then, into production of higher-priced products, and how much has that happened?

9:30 a.m.

President, Canadian Generic Pharmaceutical Association

Jim Keon

The reality is that if prices go down too low, and we're relying on suppliers internationally and they go out of business, we will have fewer suppliers available to us. That has been happening. Canadian prices have been declining. Prices have been declining in the U.S. and Europe. Around the world, generic drug prices have gone down, and that has caused supply issues internationally. It has led to shortages. It was mentioned by HealthPRO. This is not a brand-new issue. There have been some shortages over the past couple of years. So that is a factor.

We rely on international sources for our active pharmaceutical ingredients. There is some manufacturing of that in Canada. Apotex does that. But by and large we are reliant on an international supply, and that has been increasingly difficult to source.

9:30 a.m.

Conservative

The Chair Joy Smith

Ms. Boyle, do you want to make a comment?

9:30 a.m.

Vice-President, Services, HealthPRO Procurement Services Inc.

Kathleen Boyle

Yes.

Part of our new strategy—and we are putting this strategy in place in the contracts we are going to award in September 2012—is to take a multi-supplier award and not a single-supplier award for what we call hospital-specific items, which are primarily injectable products used mostly in hospitals. So wherever possible we will be looking at awarding contracts to more than one supplier, and where there is only one supplier we will be actively pursuing other suppliers to bring a product into market.

9:30 a.m.

Conservative

The Chair Joy Smith

Thank you.

Ms. Block.

9:30 a.m.

Conservative

Kelly Block Saskatoon—Rosetown—Biggar, SK

Thank you very much, Madam Chair.

I want to welcome all of our guests here today. This is certainly a very timely study, and I really appreciated all of your presentations.

I want to echo Mr. Williams' opening remarks, where he stated that their members certainly appreciate the anxiety and frustration that drug shortages cause Canadian patients, their families, and health care professionals. I think that could be said of all of us around the table here today.

We also recognize that drug shortages are a global problem, with multiple roles and responsibilities on the part of industry, provinces and territories, and Health Canada. That is why on March 11, 2011, the Minister of Health wrote to several industry associations asking that they establish a plan to share information on drug shortages with health professionals. After that, it's my understanding that the associations joined together to form a working group that plans to update Health Canada on its progress.

The minister also wrote, in April 2011, stating that this plan must include an agreed-to standard for notification of drug shortages to health professionals that is timely, accurate, and comprehensive. If the proposed plan falls short, the minister wrote that her department will be prepared to proceed with legislation that will force companies to disclose this information.

Today I will focus on asking questions of the representatives here from Sandoz.

Early last fall the Minister of Health received a commitment from several professional and industry associations for a voluntary plan to provide timely, accurate, and comprehensive information about drug shortages. I understand that you are a member of the Canadian Generic Pharmaceutical Association, which contributed to the development of this plan. However, you did not make available clear and timely information regarding the supply disruptions, which is contrary to the spirit and principles of the pledge made to the minister. Why didn't your company wait to ensure your customers were able to secure alternatives before making your business decision after the FDA's findings?

March 27th, 2012 / 9:35 a.m.

Michel Robidoux President, Sandoz Canada, Canadian Generic Pharmaceutical Association

Chair, committee members, this is an opportunity for us to reaffirm our commitment to patients and to reaffirm our commitment to quality products.

With regard to your question, I might want to go back in time a little bit to November. This is when we received the warning letter.

A warning letter is very important. It is very serious. At Sandoz, we are a health care company operating in a highly regulated environment. It is our responsibility to comply with all regulations. Definitely, it is very important for us to meet the expectations of the regulators.

At that time, there were no shortages. At that time, Sandoz had undertaken a process called “quality transformation” within Sandoz to constantly improve the quality system and to constantly improve internally our manufacturing plant and our quality operation.

The warning letter really put us in a situation where we had to accelerate the remediation activities. It is important we comply with the regulations, so it is important that we improve our quality standards, our quality system. Because of that, we had to consider managing a reduced production. We are still in the December period. When we realized our production was going to be reduced, we decided to clearly make some key decisions.

Number one, in January, our company informed the marketplace and our customers that we would be stopping production of ointments, suppositories, and ophthalmics. In light of the situation, these were less medically necessary products.

In late January, we recognized that we would need to focus all remaining production on medically necessary products. At Sandoz, we have a long list of products. We have over 225 presentations. There are 140 different molecules with a different presentation, for a total of 235. As an example, morphine is one of our products, but we provide morphine in 15 different presentations.

Going back, in late January we worked with HealthPRO, key hospitals, and key pharmacists to identify what would be the most important medically necessary products to produce. At that time, there were no shortages. At that time, we made a decision to suspend from our production, because of our reduced capacity, 74 products. It's not because you suspend 74 products that you're in back order immediately. As a matter of fact, for the majority of those 74 products, we had one month, two months, five months, up to 12 months of supply. So at that time, there were no shortages.

When we went to the market on February 15 to announce there were going to be shortages, we had previously worked with the members of CAPDM to create an allocation system in order to ensure that we would spread the distribution of our products equally to the marketplace. As of February 15, we clearly posted on our website all of the back orders and prospective back orders. After the additional request of Minister Aglukkaq, we voluntarily posted on the two sanctioned Health Canada websites all of our current and perspective back orders.

Thank you.

9:40 a.m.

Conservative

The Chair Joy Smith

Thank you.

We'll now go to Mr. Hsu.

9:40 a.m.

Liberal

Ted Hsu Kingston and the Islands, ON

Thank you, Chair.

I would like to follow up with Mr. Robidoux on that last point. Are you saying that the ministry of health was not aware of any potential shortages before February 15 and was not made aware by Sandoz before that date of any potential shortages?

9:40 a.m.

President, Sandoz Canada, Canadian Generic Pharmaceutical Association

Michel Robidoux

We have been very clear, and it is our internal rule, that whenever we have an inspection and whenever we have exchanges of correspondence regarding our manufacturing plant in Boucherville, whether it's with the Canadian or the U.S. authorities, we share and exchange....

So when we received the warning letter, we were very clear and transparent with Health Canada that we had received a warning letter. At that time, a warning letter would not immediately create a reduced production output.

The way the warning letter works...we had three weeks to respond to the warning letter, which we did. Thereafter, we realized that the production output was going to be reduced. We took this situation seriously, and at all times our decision was based on minimizing patient disruption. That's why we worked on the most medically necessary products.