Health Committee on Nov. 15th, 2022

[Don Davies, NDP, Vancouver Kingsway, BC]

I'm going to get into what you're doing about it.

A recent article in Policy Options said the following: “Drug shortages have been a...fact of life in Canada for 10 years now.” I think we've heard that it's for more than just pediatric pain medication.

It said:

The causes are many and often opaque. Manufacturing issues are cited most frequently, often stemming from quality issues, and with the COVID-19 pandemic the manufacturing and supply issues have only multiplied.

That's coming up on almost three years now.

It continued:

In fact, manufacturing disruptions now account for 62 percent of drug shortages, as per a recent Health Canada communique shared with stakeholders.

What are you doing to address the long-term structural problem of drug shortages in Canada?

[Dr. Stephen Lucas]

Mr. Chair, I'll highlight several dimensions.

One of them, as noted, is that we have over the past number of years built our internal capacity for forecasting and understanding supply and demand; early identification of potential risks and shortages; and changing our regulatory instruments to enable foreign importation. In addition, we have been working with regulatory partners to strengthen the diversification of supply chains.

Then, finally and importantly, the government has invested two and a half billion dollars to strengthen domestic biomanufacturing, both—

[Don Davies, NDP, Vancouver Kingsway, BC]

Here's where I'm going on that. I want to focus my last question on domestic supply.

In August 2020, an executive order in the United States directed the U.S. Food and Drug Administration to identify a list of essential medications and produce reliable long-term domestic supply chains for goods essential to public health.

Has Canada done the same thing? Is Health Canada taking any steps toward securing domestic supply chains of essential medicine in Canada?

[Dr. Stephen Lucas]

Mr. Chair, as I noted, the government has invested to strengthen biomanufacturing. A number of critical investments have been made, including in regard to future pandemic preparedness, but more broadly it's all components, from research through to fill and finish of product.

We have a strong generic industry that continues to grow. We are working to further strengthen innovator and domestic biomanufacturing throughout the entire chain, and we are looking at critical medicines that could be at future risk to make sure that we look at multiple strategies to address and preclude future shortages.

[The Chair, Liberal, Sean Casey]

Thank you, Dr. Lucas.

Next up we have Dr. Ellis, please, for five minutes.

[Stephen Ellis, Conservative, Cumberland—Colchester, NS]

Thank you, Chair.

Thank you to the witnesses for being here.

Certainly we know that this has been a very, very difficult time for Canadian parents. Part of the issue, I think, is transparency. It took four months for this shortage to begin to be addressed. It started in April—you made that very clear—and nothing happened until August. When did the Liberal Minister of Health become involved in all of this?

[Dr. Stephen Lucas]

Mr. Chair, as I indicated in my opening remarks, Health Canada has been engaged since the spring, and we've been active since the spring in working with manufacturers, pediatricians, children's hospitals and provinces and territories on identifying the risk and encouraging the increase in domestic production, which has been significant and, as I noted, at a record level. As Dr. Sharma noted, demand increased significantly in August, and we further engaged and heightened the tempo of work with partners and encouraged foreign importation, which is happening.

[Stephen Ellis, Conservative, Cumberland—Colchester, NS]

Through you, Chair, I think, Mr. Lucas, that clearly I asked when the minister became involved in this.

[Dr. Stephen Lucas]

Mr. Chair, we routinely brief the minister and, at instances where we work to further strengthen communication with the public—

[Stephen Ellis, Conservative, Cumberland—Colchester, NS]

A date would be good.

[Dr. Stephen Lucas]

Mr. Chair, as I said, we routinely brief the minister and make information available to Canadians, both directly through Health Canada as well as through partner organizations, including the Canadian Pediatrician Association, as Dr. Sharma noted.

[Stephen Ellis, Conservative, Cumberland—Colchester, NS]

Thank you.

Through you, Chair, if I could, we're talking about transparency here, and I'm finding it exceedingly difficult to get a transparent answer. Now we're blaming the parents by saying that we didn't want to talk about this to Canadians because we were concerned the parents might buy some more acetaminophen and ibuprofen. That, in my mind, would be almost victim blaming.

Good communication comes down to asking what our plan is. It would occur to me very clearly that the minister was not involved in this for a very, very long time, which is shameful, and that Health Canada had a very, very poor plan in place here, not to mention that I would suggest we should have anticipated that there might be a surge in the fall of the year and taken it much more seriously in April. I think that's shameful.

The second part of that would be that it's exceedingly important to rebuild the trust of Canadians. Part of that is not standing behind the fact that we can't share how many doses are coming, when they're going to get here or when they're going to be distributed. That would be an essential part of the plan of transparency to reassure Canadian parents that you're doing something. To me, standing over there and sitting over there and continuing to refuse to do that is absolutely unconscionable.

I guess my question would be, then, what are you going to do about that? How are you going to reassure Canadian parents that you've done something and that these medications that are essential are going to be on the shelves?

We do have a much bigger and looming problem, which we'll have to bring you back for, because clearly you don't appear to have the competence to do it yourselves. We're going to have to bring you back to talk about amoxicillin and azithromycin as we move into the fall and winter season.

That's a big question. Fill your boots.

[Dr. Stephen Lucas]

Mr. Chair, I and Dr. Sharma and perhaps other witnesses will respond, given the range of points that were made.

I will start by indicating, as I noted, that Health Canada, from the earliest indication of potential shortages in the spring, actively engaged manufacturers, of which there are about a dozen supporting the Canadian market, provinces and territories, children's hospitals, pharmacies, retail networks, pharmacists and pediatricians.

We continued to do that encouraging through the spring, based on our plan to increase domestic supply, which happened and is now at record levels. We have given throughout that time the opportunity to import available foreign product as an option, for which we have the regulatory tools, and indeed are now doing just that. We are importing foreign product to address that shortage for Canadians.

We have communicated with Canadians. I'll turn to Dr. Sharma to describe that. As I've explained, we have a drug shortages task force in place and a dedicated team, and we've worked to resolve literally hundreds of drug shortages every year so that there is no impact or visibility to patients. We transparently reported through our drug shortages website and have communicated with a range of stakeholders across the country to address this situation.

A very significant amount of work goes to protect the health and safety of Canadians, and for infants and children there has been a very focused effort since the spring.

I'll turn to Dr. Sharma now to speak to communication, including that which she has participated in to support information for Canadians both directly from Health Canada and through key partners, including pediatricians.

[The Chair, Liberal, Sean Casey]

Dr. Sharma, we are well past time, so please be concise. If you prefer to augment your answer in writing, that would be fine, as well.

Go ahead.

[Dr. Supriya Sharma]

Thank you, Mr. Chair.

First we would say that we feel for parents and caregivers. Being parents of young children is a difficult enough job. To try to figure out how to source medications to treat them for pain or fever is just adding to the stress. We're obviously dealing with situations with respiratory viruses now, so we understand that it's really challenging.

Health Canada's role really is a convening function to bring people together to make sure we're sharing information. In terms of Health Canada communications, as soon as we got a proposal from manufacturers to allow additional product to come in and that was approved, we communicated. Before that, we worked through our groups, like the Canadian Paediatric Society and the Pharmacists Association, to figure out what should be communicated to patients and who would be best placed to provide that information. When it's advice to parents about what to do about dosing and alternatives, it really is best placed coming from practitioners and people who are doing the health care delivery.

Certainly we can provide additional information about the communication that we did in Health Canada. Really it was a focus on what Canadians needed to know and who was best placed to provide that information to help them through this shortage situation.

[The Chair, Liberal, Sean Casey]

Thank you, Dr. Sharma.

Next we have Ms. Sidhu, please, for five minutes.

[Sonia Sidhu, Liberal, Brampton South, ON]

Thank you, Mr. Chair. Thank you to all the witnesses for being with us today.

I have a question for Dr. Lucas.

You said in your statement that demand increased significantly in August. Why did the demand increase in recent months? What factors are contributing to that?

[Dr. Stephen Lucas]

As we've noted, a number of factors are contributing to it. We have seen a more sustained level of viral infections in children, above the normal level. These are from COVID and other respiratory viruses that have increased in the fall, with respiratory syncytial virus, influenza starting now, and COVID as well.

Another dimension is that as people became more aware—and there was some communication on this in August, as Dr. Sharma noted—increased buying contributed to the demand.

It was a number of factors, but an unusually significant viral infection season impacting children has certainly been a major cause and one which we're very focused on addressing. Certainly we're doing everything we can to support children, infants and their parents and caregivers.

[Sonia Sidhu, Liberal, Brampton South, ON]

I'm wondering about the review process for importing medications.

Can you comment on the process of reviewing dosing, ingredients, cautions and warnings? What work has been done to improve the use of official languages on pediatric medication bottles?

[Dr. Stephen Lucas]

I'll turn to Stefania Trombetti and Linsey Hollett to talk about that process.

[Stefania Trombetti]

When we receive a proposal to import a foreign supply, we always review it very carefully for the safety, quality and efficacy of the drug. That involves reviewing the instructions for use, the dosing and frequency, and understanding the formulation and the ingredients that are used, because although you may have the same active pharmaceutical ingredient, it may be packaged at different dosage levels, and the other ingredients that go into making a drug may also be different. The excipients may include dyes that are not normally used. In this case I'm thinking about children's analgesics in cherry flavour, for example, or grape flavour. We really need to understand those differences and make it clear what those differences are for parents and caregivers so they know those differences and can dose at the appropriate level for the age and weight of their children and take into account any allergies that their children may have before administering the drug.

The other thing that we look at is the manufacturing conditions used in the formulation and the manufacturing and fabrication of the drug. As Dr. Sharma referred to earlier, there is an international standard called “good manufacturing practices for drugs” that we adhere to, and we make sure that any drug that is placed on the market in Canada is produced under those conditions. That is everything end to end, from how manufacturers are storing the active pharmaceutical ingredients to the training of the employees they have on the production line, as well as how they clean the equipment, the credentials of the quality assurance person who is signing off on the batches before they are released to the market, right down through to the distribution chain, making sure that any requirements related to temperature, for example, are observed and that those drugs are in full compliance with all of the requirements needed for the market here.

Maybe Linsey will want to add to that.

[Linsey Hollett]

I have nothing to add to what we look at, but I can address your question around official languages.

When we are looking at a shortage situation, our number one priority is to make sure that critical safety information gets to all the people of Canada in the language of their choice. That is why, when we have a shortage situation, the preference is always to use Canadian-authorized product to address the situation, since by law all information will be in English and French. However, when we have to consider foreign product, as Stefania mentioned, through that process, if the product coming in will not be labelled and contain all of the information in both languages, as Canadian product would, we look at how can we still ensure that the critical information is available to everyone in the language of their choice, English or French.

What we do there is look at a myriad of options. If product is going to hospitals then every unit or every shipment going to a hospital will have information in English and French.

In the situation we're talking about here, which is that there's also product on store shelves, we have multiple options to choose from, and we can implement some or all. When you purchase at a store, you can be given bilingual information. There can be signage on the shelf, a bar code or a code to scan, and as the deputy minister mentioned earlier, there's making sure on public-facing websites that information is available in all languages. When we work with companies with 1-800 numbers or help lines, we make sure that those are serviced in both official languages.

[The Chair, Liberal, Sean Casey]

Thank you, Ms. Hollett.

Mr. Garon, you have the floor for two and a half minutes.

[Jean-Denis Garon, Bloc, Mirabel, QC]

Thank you, Mr. Chair.

Earlier, my colleague Dr. Powlowski talked a little bit about drug prices. I've been talking to people in the industry recently, including drug distributors. They have told me that Canadian drug pricing regulations may be one of the causes of shortages, particularly because drug inventories are kept low.

If I am not mistaken, there has been deflation in the cost price of drugs in recent years, that is to say that prices have fallen. In the middle of the supply chain are the distributors. Essentially, they resell the drugs at the price they paid for them, but they are paid a fixed proportion of the price.

We have been aware for several years that stocks are getting lower and lower. Therefore, if there is ever an outbreak of respiratory viruses and demand peaks and there is a panic, such as that created by poor communication from the Government of Canada, we are going to find ourselves in a situation where stocks will drop rapidly and we will have fewer drugs.

In this whole issue, what is the responsibility of Canada's drug price regulatory system, particularly with respect to inventory?

[Dr. Stephen Lucas]

First of all, the key factors that have created the drug shortage situation, as I said, are the difficulties with the manufacturers—