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.

Conservative

Kelly Block Conservative 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 Conservative Joy Smith

Thank you.

We'll now go to Mr. Hsu.

9:40 a.m.

Liberal

Ted Hsu Liberal 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.

9:40 a.m.

Liberal

Ted Hsu Liberal Kingston and the Islands, ON

What did you tell the ministry of health during this January period, when there was some reduced production but there were still stockpiles, and you reduced production of, let's call it, less critical medications? What did Sandoz tell the ministry of health at that time?

9:40 a.m.

President, Sandoz Canada, Canadian Generic Pharmaceutical Association

Michel Robidoux

It was very clear to us in January. We informed them that we would see our production reduced. The first decision we wanted to make was to remove from our production schedule less medically necessary products, like ointments, ophthalmics, suppositories. Thereafter, it was very important for us to focus all available production on medically necessary products.

Just to reassure people, because I know many things have been said in the newspapers about the current supply, we are currently supplying and meeting over 80% of the Canadian demand on our products.

If I take the top six most medically necessary products as identified by the key hospitals and Health Canada, and I'd like to name them if I can—morphine, midazolam, fentanyl, hydromorphone, naloxone, and dexamethasone—these are very critical products for hospitals, and today we are meeting over 95% of the demand.

When you look at managing a warning letter, mitigating the risk to patients, we've taken very seriously working with all the various stakeholders—hospital members, distributors—to create an allocation system that would minimize the shortage.

We understand it's a very difficult situation, but in light of all of this, I think we're working tirelessly to ensure a safe supply.

9:45 a.m.

Liberal

Ted Hsu Liberal Kingston and the Islands, ON

I want to go quickly to the new websites that have been set up that were mentioned in the CGPA and Rx&D presentations. But my question is actually to HealthPRO and to Mr. Johnston.

Have you looked at these websites, and are you satisfied with the quality of these websites? Do you agree with their definitions of potential shortages? Are you happy with those websites, or do they reflect accurately what you're seeing?

9:45 a.m.

Vice-President, Services, HealthPRO Procurement Services Inc.

Kathleen Boyle

I haven't actually seen the new version of the website, if there was a version just launched.

We do know the principles under which the intention to form the website was founded, and we in fact put in a proposal to offer to provide the website for people because of our many years of experience in pharmacy, particularly in hospital pharmacy and knowing what members want. They need the information to be reliable and accurate, but more than anything they need to have it in advance, because being in the middle of a shortage is not enough, now, to fix it. You have to know ahead of time so you can start to mitigate the risk and put other options in place.

9:45 a.m.

Liberal

Ted Hsu Liberal Kingston and the Islands, ON

Mr. Johnston, are you happy with what you're seeing on the website, and with the accuracy?

9:45 a.m.

President and Chief Executive Officer, Canadian Association for Pharmacy Distribution Management

David Johnston

I think the accuracy is correct. But what you have is the first iteration. The industry has come together through the drug shortage working group, and in response to the minister's requests has come up with a solution on how to proactively and accurately report any shortages. That's the process that's going on right now, but it's not finished yet. It's the first iteration, and we're looking forward to that working group continuing to work and continuing to improve those websites so they become progressively more accurate.

Are we happy with what we've achieved at this point? Yes. Is it the end point? No.

9:45 a.m.

Liberal

Ted Hsu Liberal Kingston and the Islands, ON

For Mr. Keon and Mr. Williams, do you have plans to fund these websites on a continuing basis going forward in the future? Do you have plans to check with, say, pharmacists, people on the ground, to make sure that what they're seeing is the same as what your website is saying?

9:45 a.m.

Mark Ferdinand Senior Director, Health and Economic Policy, Canada's Research-Based Pharmaceutical Companies (Rx & D)

Just with regard to the health care professionals, we started this work last year following surveys done by the Canadian Medical Association, the Canadian Society of Hospital Pharmacists, and the Canadian Pharmacists Association. We've heard directly from health care professionals as to what they need.

I think Mr. Williams outlined what our site reports on, and those were the elements or fields of information that folks said they wanted.

To Mr. Johnston's point, the work is not yet done. We need to also provide alternatives for drugs that are in shortages, and that's the next step of work that we're working on with the working group.

9:45 a.m.

Liberal

Ted Hsu Liberal Kingston and the Islands, ON

Will you be soliciting feedback from pharmacists? That is my question.

9:45 a.m.

Senior Director, Health and Economic Policy, Canada's Research-Based Pharmaceutical Companies (Rx & D)

Mark Ferdinand

We're planning a multi-stakeholder workshop that we're looking to hold within the near term, precisely with people in the group that we've been working with over the last year. So the feedback from pharmacists, doctors, hospital pharmacists, manufacturers, and distributors are all essential ingredients to the type of site we want to build, as is that of Health Canada.

9:45 a.m.

Liberal

Ted Hsu Liberal Kingston and the Islands, ON

Is there a commitment in terms of ongoing funding?

9:45 a.m.

Conservative

The Chair Conservative Joy Smith

I'm sorry, Mr. Hsu, our time is up. Thank you.

We'll now go to Dr. Leitch.

9:45 a.m.

Conservative

Kellie Leitch Conservative Simcoe—Grey, ON

Good morning. Thank you very much, everyone, for presenting.

My questions are for the representative from Sandoz. I have to say, to start off with, that I do take issue with your comment that 80% and go for patients and parents is acceptable. I think every Canadian parent who takes a child to a hospital, every Canadian patient who goes to a hospital, expects results, and that's incumbent upon all of us who are health care professionals, but also upon you as a provider.

So that being the starting premise, you then changed to 95%. I'm not sure what the number is, 80% or 95%. Maybe it's 85%.

I've worked in this world. We do our anticipation out of what we're going to do—at least with my patients—in 90 days, but usually 180 days, or maybe in 360 days I'll know about a procedure.

Recently you agreed to a 90-day notice on drug shortages to the public on two particular websites. We've heard that not great information is provided on those websites, that there isn't information that patients find acceptable on those websites. What are you doing to ensure this commitment is met, since you are already saying you're at 80% and go, or 95%? Are you going to be at 100%?

9:45 a.m.

President, Sandoz Canada, Canadian Generic Pharmaceutical Association

Michel Robidoux

Thank you for your comment.

First, I want to be clear. I didn't say I think that 80% is acceptable. I just wanted to state the facts that today, despite the challenges that exist at Sandoz, we are providing and we are meeting over 80% of the demand. One piece of information that is very important for us is that for the last several weeks, health care professionals have had access on our website to a very comprehensive status report on all of our 235 molecules and presentation.

On the sandoz.ca website, health care professionals have complete visibility on the production status of our products, the current allocation, the prospective allocation, the current back order, and the prospective back order. We have been working—

9:50 a.m.

Conservative

Kellie Leitch Conservative Simcoe—Grey, ON

Available 90 days ago.

9:50 a.m.

President, Sandoz Canada, Canadian Generic Pharmaceutical Association

9:50 a.m.

Conservative

Kellie Leitch Conservative Simcoe—Grey, ON

When was that made available?

9:50 a.m.

President, Sandoz Canada, Canadian Generic Pharmaceutical Association

Michel Robidoux

This has been made available for the last four weeks.

9:50 a.m.

Conservative

Kellie Leitch Conservative Simcoe—Grey, ON

So not 90 days, let's be clear. Twenty-eight days?

9:50 a.m.

President, Sandoz Canada, Canadian Generic Pharmaceutical Association

Michel Robidoux

You're talking about the report?