Health Committee on Nov. 15th, 2022

[The Chair, Liberal, Sean Casey]

I call this meeting to order.

Welcome to meeting number 42 of the House of Commons Standing Committee on Health.

Today we meet for two hours with witnesses on our study of over-the-counter pediatric medication.

I see that we have a couple of members participating online who are well aware of the procedures and the fact that the hybrid format is permitted pursuant to the House order of June 23, 2022.

We're going to get right into welcoming the witnesses. We have a panel in front of us today who are quite familiar with the committee, as we are with them.

We have Dr. Stephen Lucas, deputy minister of Health Canada; Dr. Supriya Sharma, chief medical advisor and senior medical advisor in the health products and food branch; Stefania Trombetti, assistant deputy minister, regulatory operations and enforcement branch; Linsey Hollett, director general, health product compliance; and Dr. Kim Godard, director, health product inspection and licensing division, regulatory operations and enforcement branch.

Thank you all for being with us here today.

I understand that Dr. Lucas is going to lead us off.

You have up to five minutes, Doctor. Welcome to the committee. Thanks for being here. You have the floor.

[Dr. Stephen Lucas, Deputy Minister, Department of Health]

Thank you, Mr. Chair.

Good morning, and thank you for the opportunity to appear before the Standing Committee on Health today to participate in the discussion on the availability of non-prescription analgesics for infants and children.

As you noted, I am joined by a number of colleagues from Health Canada. They are Dr. Supriya Sharma, Stefania Trombetti, Linsey Hollett and Kim Godard, who will work with me to respond to your questions.

First, I want to emphasize that the shortage of pediatric analgesics is a top priority for Health Canada, and all efforts are being taken to resolve this shortage.

We share the concerns of everyone in Canada touched by this shortage. We also understand the impact that it is having on children in need of these medications and the stress it has created for parents and caregivers.

With the time that I have for my opening remarks, I would like to share with the committee a quick snapshot of the work that Health Canada has been undertaking to mitigate the effects of this shortage.

Drug shortages are a complex and multi-faceted issue with a range of stakeholders having roles to play. Mitigating and resolving drug shortages require a collective effort of many players. Health Canada’s experience in managing shortages, the regulatory tools at its disposal and well-developed government-to-government networks and stakeholder relationships have provided Canada with a solid foundation to address shortages.

In regard to pediatric analgesics, Health Canada has been actively engaging in bringing together manufacturers, distributors, retailers, provinces and territories, children’s hospitals, the Canadian Pharmacists Association, and industry associations and health care practitioners, including the Canadian Paediatric Society, to assess demand, assess the options for expanding supply and implement measures to limit the effects of the shortage. Our engagement has been constant over many months, with daily interactions with key stakeholders over the last number of months.

Companies who supply the Canadian market, be they large or small, have ramped up their supply. Some manufacturers are now producing these products at record levels in Canada; however, demand continues to outpace supply. Health Canada is using other tools at its disposal to increase the supply, including facilitating the importation of foreign products.

When Health Canada first became aware of supply constraints for these products in the spring, we reached out to the suppliers and made it clear that regulatory flexibilities to permit the exceptional importation of foreign product were available and could be used to increase the supply coming into Canada.

With the information available at that time, the mitigation approach adopted by suppliers was to ramp up domestic production. The department continued to engage multiple players in the supply chain over the following months, but by late summer the unprecedented spike in demand made clear that ramping up production would not be sufficient. Again, the department sought proposals from market authorization holders for the importation and sale of foreign-authorized supply.

In a statement released yesterday by Health Canada, we advised Canadians that we have secured foreign supply of children’s acetaminophen that will be available for sale at retail and in community pharmacies in the coming weeks. The amount to be imported will increase supply available to consumers and will help address the immediate situation. To further increase supply, Health Canada has also approved the exceptional importation of infant and children’s ibuprofen and acetaminophen to supply hospitals in Canada. The importation of ibuprofen has occurred, and distribution has begun.

Each proposal received from a company to import a foreign-authorized product undergoes careful review by Health Canada to confirm that the product was manufactured according to standards of safety, quality and efficacy that are comparable to those for all drug products approved for use in Canada.

For foreign supply of children's analgesics, in addition to meeting the required safety standards, information related to cautions and warnings, dosing directions, ingredients, and other important details will be made available in both English and French to ensure parents and caregivers clearly understand what medication they are using and how to give it to their children.

As foreign product generally does not have important safety information available in both official languages, Health Canada works to ensure this is not an impediment to importation.

When this involves products at a retail level, this can be done, for example, by providing and visibly posting a QR code, website information and paper printouts in community pharmacies and retail stores where the safety information can be accessed.

Health Canada is continuing to work alongside suppliers to facilitate more product coming into Canada to fill the supply needs. We know that companies are continuing to produce at record levels to meet the needs of Canadians.

In addition, through the exercise of regulatory flexibility, Health Canada has facilitated greater access to these needed medications by temporarily allowing the sale of compounded acetaminophen or ibuprofen without a prescription. Regulations on the safety and quality of these products continue to apply. This measure will be in place until the shortage is resolved.

I will conclude by reaffirming that addressing this issue is a top priority for Health Canada. All possible efforts are being made to mitigate the shortage of pediatric analgesics. The health and well-being of infants and children has been and remains our highest priority. Health Canada has been actively engaged since observing early signals of a potential shortage. We have and will continue to dedicate significant resources to resolving the shortage. As I've noted, we have mobilized, convened and worked with all the players involved to address it as quickly as possible and on a sustained basis over many months.

We will continue to communicate with Canadians, including through the dedicated pediatric analgesics information on our website.

We look forward to today's discussion and will be happy to answer any questions that committee members may have.

Thank you, Mr. Chair.

[The Chair, Liberal, Sean Casey]

Thank you, Dr. Lucas.

We're now going to begin with rounds of questions, starting with Mrs. Goodridge, please, for six minutes.

[Laila Goodridge, Conservative, Fort McMurray—Cold Lake, AB]

Thank you, Mr. Chair. Thank you to our witnesses for being here on this critically important issue.

I'm going to start out by asking when Health Canada became aware of this shortage and the crisis.

[Dr. Stephen Lucas]

Mr. Chair, Health Canada first received reports last spring—in April—concerning some issues in some provinces, like Ontario and Newfoundland, for example. We sought further information and engaged the range of stakeholders, including the manufacturers and market authorization holders.

Certainly, from that part onwards, we engaged a group of stakeholders and made clear the opportunity to augment supply through the importation of foreign product.

[Laila Goodridge, Conservative, Fort McMurray—Cold Lake, AB]

I don't have much time, so I'm going to ask relatively short questions. I'm going to ask that you perhaps respect and answer relatively shortly, if possible.

I'm the member of Parliament for Fort McMurray—Cold Lake. Up in northern Alberta, we don't really have an option to drive across a border to get these medications, which are in vast supply down in the States.

I didn't even know that was an option. I just thought I was a mom going crazy in April when my little guy was teething and I could not find these products. I thought it was just a supply chain issue. I would come to Ontario and I could still find them. I wasn't as stressed out as perhaps I could have been, but it was ridiculously stressful.

The last time I saw these products on the shelves in my community was May. That's terrifying for a community that's five hours from children's hospital.

When did you start to procure products from elsewhere?

[Dr. Stephen Lucas]

Mr. Chair, I'll start the response then I'll ask my colleague, Stefania Trombetti, to augment it.

As I had indicated, at the earliest signs of issues last spring, we started engaging the industry on supplying the Canadian market asking them to ramp up production, which they've done. We asked them to provide the input, as well as through retail networks from pharmacists, pediatricians and others, about what was going on.

From that time, we have both requested and conveyed the importance of increasing supply through increasing domestic production as well as by importing product from foreign jurisdictions.

[Laila Goodridge, Conservative, Fort McMurray—Cold Lake, AB]

Some of the news reports have stated that the first international shipments of acetaminophen and ibuprofen are slated to go to our hospitals. How close were our hospitals to running out of supply?

[Dr. Stephen Lucas]

I'll turn to Stefania.

[Stefania Trombetti, Assistant Deputy Minister, Regulatory Operations and Enforcement Branch, Department of Health]

We know that hospitals, Mr. Chair, were running very low on supplies. As we do in shortages all the time, part of the mitigation measures are to manage the supply that already exists. They were managing that supply. They did have supply, but obviously these additional supplies are very welcome to those hospitals.

[Laila Goodridge, Conservative, Fort McMurray—Cold Lake, AB]

I'm looking at Drug Shortages Canada. I've learned a lot about drugs in the last very short period of time. It's not something I thought I would have to do as a brand new mom, but that's the case.

I'm seeing that there are shortages of other drugs, such as amoxicillin and azithromycin. They are pretty basic antibacterial antibiotics.

What other pediatric medications are in shortage? What is Health Canada doing to prevent us from having a crisis?

[Stefania Trombetti]

You're correct. The drugshortagescanada.ca website is a very transparent way to see what drugs are in shortage.

I'll put that into perspective. You're correct that there are other pediatric drugs that are currently in shortage. That does not necessarily mean that there will be a stock outage. At this point, there are about 800 drugs in shortage in Canada. To put that into further perspective, with regard to those that reach the national critical level, at this point we have 22. On a regular basis, we do manage these shortages successfully.

On the other two you mentioned, azithromycin and amoxicillin, when we receive signals, we take them seriously. We look to understand what the situation is with the suppliers, what the supply looks like, what the demand looks like, what the reason for the shortage is and what the anticipated end date of the shortage is. We always look at how we can manage supply that exists and how we can shore up that supply. In some cases, manufacturers are able to ramp up supply or bring in supply that is manufactured in other markets.

I'll speak about one example because you asked about examples.

Caffeine citrate, for example, is another drug that you'll see on that list that is currently at a national critical level. It's used to treat infants and newborns with apnea. In that situation, we have been able to understand early in the shortage what the supply gaps will be and to work with manufacturers to make sure that we have supply coming in that will fill those supply gaps before they are even felt.

[Laila Goodridge, Conservative, Fort McMurray—Cold Lake, AB]

Why are we seeing this in Canada and not seeing it elsewhere in the world? This is an absolute failure of the government leadership, because for months the idea was that it wasn't Canada's problem. We didn't see public information coming out from the Government of Canada—even telling parents that they're not going crazy and that this is an actual problem—until it was brought up in question period, and all of a sudden now Health Canada is responding.

Why did it take that long for us to get any attention? I brought this up in the committee in September, and it was crickets from Health Canada—crickets.

[The Chair, Liberal, Sean Casey]

We're well past time. Keep your response short, please.

[Stefania Trombetti]

The issue of drug shortages is not unique to Canada. Many other countries in the world experience shortages and, like Canada, have mitigation measures that they put in place as soon as they identify signals of shortages. Health Canada works behind the scenes. Many of these shortages will not be felt or seen at the patient level. That may be why you haven't heard about it—because they are being managed.

[The Chair, Liberal, Sean Casey]

Thank you.

Next up is Dr. Powlowski for six minutes.

[Marcus Powlowski, Liberal, Thunder Bay—Rainy River, ON]

Well, as you may or may not know, I'm a doctor. I still work a little bit in medicine. Before going into politics, I was an emergency room doctor in Thunder Bay for about 18 years.

I have to say that I kind of disagree with you when you say that Canada has a history of managing drug shortages successfully and that we have a foundation for addressing drug shortages. It didn't start with the Liberal government. I was working in an emergency room from 2003 or 2004 in Canada, and in the hospital we were constantly undergoing shortages, often of important drugs like etomidate, which you need for rapid sequence induction in the emergency room. At times we were out of IV Levaquin, which is the primary go-to drug with community-acquired pneumonia. We were out of pediatric bicarbonate, which is just baking soda and water, and Stemetil, which is, and continues to be, the best IV drug to treat migraines. We haven't been able to get that in Canada for years. This was constantly a source of frustration for me in the emergency room, and I don't blame it all on the federal government. The hospital wasn't interested in addressing this issue. They'd just tell us, “Well, we're out of the drug.”

My understanding of the regulatory process, especially for drugs that are off-patent, is that it's rather onerous. There are a lot of hurdles you have to clear. You have to get a drug product licence and you also have to have an establishment licence. My understanding is that it's easier to import drugs from countries where we have a shared good manufacturing process, but especially with drugs that are off-patent, my understanding is that the profit margin is fairly small, and if, for instance, an Indian or Chinese company wants to get that product into the market in Canada, it has to go through all these hurdles, which are fairly onerous. Given that often the profit margin for some of these drugs is small—that isn't the case for acetaminophen, for which there's a big market—and the market is much more limited and the regulatory process is complex, they don't want to do it, and that's why these products aren't getting to the market in Canada.

That's certainly how I, as a doctor, perceive the problem. I don't know whether that's Health Canada's perception of the problem. As an emergency room doctor, I was really frigging frustrated with constantly having this process with drugs, so how can we address this problem?

[Dr. Stephen Lucas]

Mr. Chair, I will start by indicating that Health Canada has taken and continues to take the issue of drug shortages very seriously. We have certainly seen the challenges increase over the past decade. The challenges are of a global nature with supply chains. In some cases, the active pharmaceutical ingredient is coming from just a single supplier. We've been working domestically to strengthen our capability in Health Canada—with Stefania's team and with colleagues here—to have a focused organizational unit and task force working to address it.

There has also been work globally, and Stefania co-chairs an international group of regulators looking at this issue. Certainly, as we saw in the pandemic, the importance of supporting domestic biomanufacturing is a critical priority and one in which the government has invested significantly to attract and support businesses and develop manufacturing operations in Canada.

We routinely work with—and we recently updated, in 2021—regulatory authorities to further facilitate addressing drug shortages. My colleagues can speak to that. As Stefania said, at any point in time we could be having supply challenges with 10% to 15% of drugs, but we work actively with multiple suppliers to avoid, to the greatest extent possible, those having impacts at the clinician and importantly at the patient and care provider/parent level.

As well, we have worked to look at novel ways of addressing it, including, during the pandemic, by establishing a critical drug reserve with provinces and territories.

We are fully engaged in addressing this and in using regulatory flexibilities to help ensure that Canadians get the supply of drugs they need.

[Marcus Powlowski, Liberal, Thunder Bay—Rainy River, ON]

Thank you.

Having worked in a lot of different developing countries, I can tell you that the issue of drug supply is a critical one all over the world. Certainly all over the world there's concern about getting good, cheap medications but also drugs that are effective. That's certainly a challenge.

What is Canada doing with other countries in order to have some sort of global approach to the problems—some sort of common standards that other countries can look to in ensuring that a medication that's being bought and used on patients in those countries as well is actually effective and safe?

[Dr. Stephen Lucas]

I will start and then turn to Dr. Sharma and Stefania on this.

Canada works through Global Affairs Canada in supporting increasing access to needed medicines, as was the case and continues to be the case in the pandemic, with access to vaccine treatments and diagnostics through organizations like COVAX. In addition, we have extensive regulatory co-operation on a global scale.

To speak to that, first I'll turn to Dr. Sharma.

[Dr. Supriya Sharma, Chief Medical Advisor and Senior Medical Advisor, Health Products and Food Branch, Department of Health]

Thank you, Mr. Chair.

The manufacture of pharmaceuticals is absolutely global. It's not unusual to have a pharmaceutical where the active pharmaceutical ingredient comes from one country, the first part of manufacturing happens in another country and then maybe packaging and labelling happens in another country before it would come to the country in which it's sold. That's why it's really important that we have harmonized international standards to make sure that regardless of where those ingredients come from or where the finished drug product comes, they meet the standards for safety, efficacy and quality in Canada.

That's the case no matter where it's manufactured. An incredible amount of work goes on internationally on standards for the places where the manufacturing is happening, through what we call “good manufacturing practices”. That's basically the same everywhere in the world.

As well, there's a lot of work on harmonization of the technical standards of how those medications are looked at. A group called the International Council on Harmonisation involves multiple countries from around the world, along with industry, to put together those technical standards.

Again, because of the global nature, it's really important that we have harmonization and can rely on those medications being safe and effective and of high quality.

[The Chair, Liberal, Sean Casey]

Thank you, Dr. Sharma.

Mr. Garon, you have the floor for six minutes.

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

Thank you, Mr. Chair.

I thank all the witnesses for being here today.

I would like you to keep your answers short, because I just want to make sure I understand the situation.

Since last spring, Health Canada has been aware that there is a shortage of a number of drugs. This is a well-known fact. You tell us that there are problems with the supply chain and that this happens frequently in other countries. I would like you to name me another G20 country where today I could not find infant or children's Tylenol on the shelves in pharmacies. I want you to name a country.

[Dr. Stephen Lucas]

I would point out that drug shortages are a global problem. There are drugs for which there is a shortage in other countries as well as in Canada. On the other hand, there are situations that are unique to Canada.

Other countries with shortages of infant or child painkillers include Germany and the UK. I would ask Ms. Trombetti to complete the list.

[Stefania Trombetti]

That's correct.

There are constraints that we know of in countries like Germany, France and Ireland. You are correct that the impact isn't as felt as it is here, but there are constraints for sure in other parts of the world.

The way shortages—