Health Committee on Nov. 15th, 2022

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

I apologize for the interruption, but I have very little time to speak and my question is not being answered. I want to know what role the drug price regulation system plays.

[Dr. Stephen Lucas]

First, the cost of drugs appears to be a key factor in creating shortages in Canada, plain and simple.

Second, the regulatory system in Canada, in this case the Patented Medicine Prices Review Board, or PMPRB, ensures that Canadian consumers are protected from excessive prices. The regulation in this case is clear. It is not a blanket regulation; it specifically protects against excessive prices. This has a direct impact on the quantity of drugs approved and used in Canada.

[The Chair, Liberal, Sean Casey]

Thank you, Mr. Lucas.

Mr. Davies, you have two and a half minutes.

[Don Davies, NDP, Vancouver Kingsway, BC]

Thank you.

Ms. Hollett, I have sat on this committee since 2015 and through the entire COVID pandemic. When we asked for details about the COVID vaccines, the government always claimed commercial reasons for not disclosing information religiously, but one thing they always gave was the numbers.

I think when the government wants to release numbers to try to make itself look good, such as when it is procuring lots of COVID vaccines, commercial sensitivities don't seem to be a problem when releasing the number of doses. However, now there's a shortage, and all of a sudden the government is claiming commercial sensitivities to not release the numbers it had no problem releasing for vaccine doses. It's citing the exact same reason.

Can you explain that to me?

[Linsey Hollett]

One thing I should have added earlier is that while I am not able to share now, work is under way with the companies that we have been working with and are importing from to make public the information that is being asked for in very short order on the public-facing Health Canada website.

The need for that information and the importance of that information have been recognized. We're very close to being able to publish it again in a public forum.

[Don Davies, NDP, Vancouver Kingsway, BC]

Why would you say that? The customers for these doses are the people of Canada. They are paying for them. When there's a drug shortage, parents looking for drugs for their children have a right to know how many doses are coming, in my opinion.

Australia's medicine supply security guarantee requires that Australian medicine manufacturers hold four to six months' worth of stock of critical medicines, particularly those that have historically experienced shortages within the country, to provide a buffer in the event of global medicine shortages.

Do we have the same policy in Canada?

[Dr. Stephen Lucas]

Mr. Chair, what I would say is that we notably have a variety of strategies to both mitigate the risk of and address the event of drug shortages—

[Don Davies, NDP, Vancouver Kingsway, BC]

Mr. Lucas, with respect, I didn't ask what strategies we had. I asked if we have a similar policy.

[Dr. Stephen Lucas]

What I was working to say, Mr. Chair, is we have a variety of tools available now. We continue to look at other strategies, including essential medicines that we established during the pandemic—as has been transparently documented, a critical drug reserve—and we are learning the lessons from that as we consider it going forward.

[Don Davies, NDP, Vancouver Kingsway, BC]

You said that hundreds of drug shortages are resolved per year. That sounds like we have normalized a disaster. It sounds like we're used to having hundreds of drug shortages every year, and you're claiming success that somehow we can avert disaster on this one.

Isn't the fundamental problem that Canada does not have a domestic supply of critical medicines, and that's where we need to be addressing our efforts, not on better reporting of the shortages?

[Dr. Stephen Lucas]

Mr. Chair, I have spoken—

[The Chair, Liberal, Sean Casey]

You get the last word, Dr. Lucas. That was the last question.

Go ahead.

[Dr. Stephen Lucas]

I have spoken about multiple strategies being undertaken, including strengthening our capability, working with global regulators, working with manufacturers, strengthening domestic biomanufacturing as that strengthens work to resolve issues domestically, and looking at the experience from the pandemic in the critical drug reserves. We're looking at multiple strategies.

Obviously, our goal is to ensure that Canadians have access to the medications they need when they need them, and that they are safe, of high quality and effective. We will continue to work toward that, supporting, in particular in this moment, children and infants and their parents and caregivers to address this current challenge with pediatric analgesics as quickly as possible and using every tool possible.

[The Chair, Liberal, Sean Casey]

Dr. Lucas and your team, thank you so much for being here. We have another panel of witnesses who will be speaking to this issue in the second half of the meeting. As always, we appreciate your coming, in this instance on fairly short notice, and the patience you've exhibited with us on this very difficult issue. Thanks again.

Colleagues, we will suspend for five minutes while we bring in the next panel of witnesses. You can stretch your legs and get a bite if you want.

We stand suspended.

[The Chair, Liberal, Sean Casey]

I call the meeting back to order.

I'd like to welcome our witnesses for the second panel.

I have just a few comments for the benefit of the new witnesses, specifically Dr. Ahmed, who is participating online.

Dr. Ahmed, you have interpretation on your screen. You have the choice of either floor, English or French.

For those in the room, you can use the earpiece to select the desired channel.

Mr. Garon, I can confirm that sound and connection tests have been carried out with Dr. Ahmed and that the sound quality is good.

I would now like to welcome our next panel of witnesses.

From the Association québécoise des distributeurs en pharmacie, we have Mr. Hugues Mousseau, director general.

From Children's Healthcare Canada, we have Emily Gruenwoldt, president and chief executive officer.

From the Critical Drugs Coalition, we have Dr. Saad Ahmed, physician, appearing by video conference from Vancouver.

Finally, from Food, Health & Consumer Products of Canada, we have Gerry Harrington, senior adviser.

Thanks to all.

Mr. Mousseau, I invite you to begin. You have five minutes for your opening statement. Welcome to the committee, sir.

You have the floor.

[Hugues Mousseau, Director General, Association québécoise des distributeurs en pharmacie]

Thank you, Mr. Chairman.

Members of Parliament, thank you very much for welcoming me here today to discuss an issue as vital as the supply of medication for the children of Quebec and Canada.

My name is Hugues Mousseau and I am the director general of the Quebec Association of Pharmacy Distributors. In this capacity, I represent the distributor-wholesalers in Quebec, who provide more than 16,000 deliveries each week to all hospitals and pharmacies in the province, whether in downtown Montreal, Blanc-Sablon, the North Shore, or even the Magdalen Islands.

As Quebeckers and Canadians, we have made the choice that all our citizens have access to the medicines they need, when they need them, no matter where they live. This is no small decision for a territory with one of the lowest population densities in the world.

For nearly a year, in Quebec, demand for over-the-counter analgesics has remained at nearly double the historical demand for these drugs. Although the major manufacturers have also managed to double their supply to our distribution centres, the strength of demand is preventing us from replenishing pharmacy and warehouse shelves at this time.

In plain English, everything we receive is immediately shipped to hospitals and pharmacies. The imports recently confirmed by Health Canada are welcome, and I would like to confirm at the outset that the issue of the language of labelling on imported products is a false debate. I will come back to this a little later.

Since the drug supply chain is complex, my aim today is to give you a brief overview of its main components, and then to conclude by giving you some possible solutions to better combat drug shortages.

The starting point of the drug supply chain is provided by the active ingredient factories, mainly located in South-East Asia and Eastern Europe. The chemical compounds from these plants are shipped to the drug manufacturers, who also package and market the products.

The wholesalers I represent buy almost all of the manufactured drugs and resell them at cost to pharmacies and hospitals. The wholesalers are paid according to a model set by the provincial governments. In Quebec, this takes the form of a fixed percentage of the list price of each drug.

This funding model applies consistently regardless of the region of drug distribution and regardless of the type of drug, whether it is narcotics from secure storage, refrigerated products, or cytotoxic drugs whose handling parameters are complex and highly specific.

In fact, Quebec and Canada can count on a drug supply chain that is among the safest and most efficient in the world. This is perhaps one of the most overlooked strengths of our health care system.

Six companies manage drug distribution centres in Quebec. Our members alone represent the most important bulwark against drug shortages. With multi-week stockpiles, strategic stockpiling and a keen understanding of market dynamics, our members can continue to meet the needs of Canadians even if a supply disruption occurs upstream in the chain.

However, this bulwark is now under threat. In recent years, extreme downward pressure on drug prices and a lack of predictability regarding market conditions have weakened the drug chain, with the direct consequence of increasing the number, frequency and duration of shortages.

In fact, according to calculations made by our association, the number of prescription drug shortages has quadrupled in five years in Quebec.

Since then, the problems of price cuts and lack of predictability have been compounded by issues related to inflation and the skyrocketing cost of fuel, in addition to the ever-increasing regulatory burden. Faced with this critical situation, wholesalers will have no choice but to consider reducing the number of weeks of drug stock and reducing the frequency of deliveries to pharmacies.

If the government does not act soon, the reform of the Patented Medicine Prices Review Board and the negotiations of the pan-Canadian Pharmaceutical Alliance will lead to further reductions in the list price of drugs, thereby amplifying the shortage problem. Yet viable alternatives have been proposed to the government and the PMPRB for three years.

Let me be very clear: wholesalers are in favour of price cuts for drugs if they do not undermine supply and innovation. In fact, there is already a mechanism in place across the country called listing agreements, which is a viable alternative for achieving savings while isolating the effect on the drug supply chain and shortages.

I would like to conclude my remarks with some additional observations and suggestions in relation to the shortage of pediatric analgesics and other medicines.

In our view, three concrete solutions will better equip us to respond to shortages in the future.

First, we must put an end to successive and unpredictable price cuts by focusing on contractual and financial mechanisms other than a reduction in the list price, such as listing agreements.

Secondly, we need to stop the critical erosion of distribution funding and reinvest in our supply chain to allow wholesalers to play their full role as a bulwark against shortages.

Finally, we need to work with wholesalers to establish national stocking strategies for critical medicines with a view to optimal stock management according to expiry dates.

Thank you.

[The Chair, Liberal, Sean Casey]

Thank you, Mr. Mousseau.

Next we have Emily Gruenwoldt, president and CEO of Children's Healthcare Canada.

Welcome back to the committee, Ms. Gruenwoldt. You have five minutes.

[Emily Gruenwoldt, President and Chief Executive Officer, Children's Healthcare Canada]

Good afternoon, and thank you for the return invitation.

My name is Emily Gruenwoldt, and I am the CEO of Children's Healthcare Canada and the executive director of the Pediatric Chairs of Canada.

Children's Healthcare Canada is a national association. We represent all 16 of Canada's children's hospitals as well as community hospitals, rehabilitation centres, home care, and palliative centres caring for children and youth. We have a unique systems perspective on the continuum of care for children, a population of eight million and growing. The Pediatric Chairs of Canada are the 17 department heads of the pediatric departments in our medical schools across the country.

I'm pleased today to join you to provide input on how the shortages of children's analgesics are impacting the delivery of health care within our hospital settings and exacerbating strains on emergency departments and entire hospital systems.

It's no secret that a very large number of children across this country are very sick, Whether it is influenza, RSV or even COVID-19, parents and caregivers have their hands full. Typically, these respiratory infections can be managed at home with readily available, over-the-counter pediatric medications, including acetaminophen and ibuprofen. Of course, we know these products are and have been in short supply for several weeks and months.

Parents are struggling to alleviate symptoms at home and are seeking out the assistance of their primary care teams, community pharmacies and, increasingly, emergency departments.

From coast to coast, children's hospitals in particular, but also many regional community hospitals, are experiencing historic volumes of young patients visiting their emergency departments, in part due to the lack of formulations to treat the symptoms of this perfect storm of respiratory illnesses, which shows no sign of abating.

Here's what we are seeing and hearing across the country.

At the Janeway Children's Hospital in St. John's, Newfoundland, their emergency department occupancy topped 200% over the weekend. Their hospital is operating at over 100% capacity.

In Halifax, the IWK emergency department and ICU have declared a code census, which for 14 days reflects severe overcapacity. The IWK emergency department recently registered 200 patients in one 24-hour period, setting a hospital record. Making matters worse, that same day, the IWK saw their highest-ever number of patients triaged as seriously ill and requiring admission. Last week, between 11 and 32 patients left unseen each shift.

In Montreal last week, the emergency department at CHU Sainte-Justine was operating at 300% occupancy, and at Montreal Children's Hospital, it was at 250%.

In-patient occupancy at McMaster Children's Hospital in Hamilton hit 140% on Friday, November 11.

Yesterday, SickKids Hospital reduced surgical activity to focus exclusively on emergency and urgent surgeries to create capacity for critically ill children. Half of the kids in their ICU are on a ventilator.

CHEO, our children's hospital down the street in Ottawa, announced last week that they have opened a second pediatric intensive care unit to care for the most critically ill children. As of Friday, this new ICU reported 280% occupancy.

Ontario has created capacity for most critically ill children by now decanting pediatric patients over the age of 14 to adult facilities.

In Edmonton, wait times at Stollery Children's Hospital have reached 20 hours for care.

Many of our children's hospitals across the country are now activating emergency operation centres to better manage patient access and flow. These are only a few examples, but the story is consistent. Across the country, we are seeing record numbers of children visiting emergency departments, record numbers of admissions, record acuity of patients being admitted, record waits to be admitted, record wait times for time-sensitive surgical interventions, record staff shortages and mounting public frustration.

Beyond exacerbating challenges within the emergency setting, children's and community hospitals commonly rely on analgesics prior to and after surgical interventions to manage pain and also to reduce the use of opioids and reduce the likelihood of developing chronic pain. Some children's hospitals are now evaluating whether or not they can perform essential surgical interventions based on the availability of analgesics to manage patients' care before and after surgery.

As many in the room will know, the Canadian pain task force recently published an action plan for pain management in Canada. A foremost goal was to ensure access to appropriate pain care for all Canadians. The report shared three important recommendations that are relevant to our discussions today.

First, the report shares evidence that reveals that treating pain with analgesics is not only the right thing to do, it also spares the use of opioids. From an access perspective, the report underscores a necessity to ensure appropriate pain management for our most vulnerable populations, including children. Lastly, the report speaks to the moral and financial imperative to prioritize the prevention of chronic pain, which is not only disabling for children, but creates long-term health system challenges.

I think we can agree that the current situation is both unacceptable and unsustainable. Elongated shortages of essential medicines, whether over the counter or prescription, are inexcusable in a country like Canada. While this overnight crisis in pediatrics has been actually decades in the making, there are solutions that will provide much-needed relief, even if just in the short term.

I'd be happy to elaborate on some of these ideas during the question and answer period.

Thank you.

[The Chair, Liberal, Sean Casey]

Thank you very much, Ms. Gruenwoldt.

Next, from the Critical Drugs Coalition, we have Dr. Saad Ahmed, physician.

Dr. Ahmed, welcome to the committee. You have the floor.

[Dr. Saad Ahmed, Physician, Critical Drugs Coalition]

Thank you for having me.

Dear honourable members, in the context of the committee's urgent study on the shortage of pediatric acetaminophen formulations, and on behalf of the Critical Drugs Coalition, which is a non-partisan and grassroots coalition of frontline physicians, pharmacists, academics and pharmaceutical industry experts, I'm speaking to provide recommendations for how the federal government can improve the resilience and security of Canada's drug supply chain.

I should note that the Critical Drugs Coalition and I have no conflicts of interest, financial or otherwise. I'm a lecturer with the University of Toronto's Department of Family and Community Medicine. I was also formerly a rural physician, having worked in remote settings all across northern Ontario, from remote indigenous communities in Moose Factory to small but very busy towns, particularly emergency departments in Kenora. I now work at the Vancouver General Hospital's ICU, as well as at the George Pearson Centre, which is a facility for patients with very complex disabilities. I have a breadth of experience. I've collated my personal experience from these settings and my colleagues' ongoing experiences with drug shortages.

I should add that I did have the pleasure of speaking to this committee in May of 2021 in the context of the critical drug shortages that occurred during the peak of the COVID-19 pandemic. At that time, the Critical Drugs Coalition made a number of recommendations to secure our drug supply going forward. Those included better data on the supply of such drugs, the creation of a critical medicines list, and the stockpiling of said critical medicines in a critical drug reserve, especially in anticipation of our respiratory flu seasons and further waves of COVID-19.

This was all included in a public open letter that we had issued to the Prime Minister in August of 2020. It had been supported and co-signed by multiple national bodies, such as the Canadian Medical Association and the Ontario Medical Association.

Our asks were very clear at that time. To reiterate, our asks were three points. We asked for a pan-Canadian critical medications list that the government commits to ensure is always in stock; public support for a generic critical drugs manufacturer to increase redundancy and capacity for said critical drugs; and greater transparency, data and communications to and from the governments and the health sector around the critical drug supply.

We did hear in April of 2021 from the minister, and there was an announcement around a critical drug reserve. Obviously, Health Canada folks have mentioned that billions have been spent on biomanufacturing.

However, my understanding is that the critical drug reserve has now been wound down. It is unclear to me at this point whether we do have any kind of policy and framework around strategic reserves of critical drugs.

I won't reiterate this, as I do know that we've spoken at length about the causes of the shortages. I will just mention that a cursory review of the drugshortagescanada.ca website for children's acetaminophen formulations states that the 80-milligram-per-millilitre suspension has been short due to manufacturing disruptions, so we've been really relying on the 160-milligram-per-millilitre suspension. From what I've heard from our industry sources, demand is up by about 400%, despite manufacturers having increased their manufacturing by about 200%.

Really, this is a perfect storm of supply strain and domino effects on other drugs. We're hearing about amoxicillin, azithromycin and ibuprofen shortages. It's really taxing our health care system, as we have also heard.

We are importing pediatric formulations and certainly folks have spoken about that. It's interesting because the United States has not experienced any significant shortages of acetaminophen. We've been hearing about people bringing bottles of acetaminophen back in the suitcases and other stopgaps, like going to compounding pharmacies, etc., to try to get some specific formulations made.

I do think that while we have an urgent importation order and a number of solutions for the crisis at hand, we must commit to addressing the root causes of such shortages going forward.

I'd like to reiterate what we said back in May of 2021, which is that we really need better data on the supply of such drugs. How much drug is inside of Canada at one time is something we need to know, as well as where the important components of our drugs are actually made. That's the first thing when it comes to better data.

We need a creation of a critical medicines list. I think people are using the words “critical medicines”, but what does that actually mean? You look at the UN list of essential medicines— there are thousands of them.

We actually truly need to understand what a critical medicine is, and then have policies, such as stockpiling of said critical medicines. It doesn't necessarily have to be physical stockpiling. It could be other sophisticated strategies, such as redundant manufacturing capacity in domestic or friendly countries' manufacturing plants, or strategic reserves of the active pharmaceutical ingredients that create these finished pharmaceutical products.

There are really the three points that we're going to continue to drive home, and something has to be done, because we are seeing rolling shortages of other drugs. People have mentioned azithromycin and amoxicillin. I really do think that if I were to bring it home, I'd say that we need to define “critical drugs”.

I would put in a plug here for a very sharp colleague of mine, Dr. Mina Tadrous, who is a pharmacist and a researcher at the U of T and the Canadian expert on drug shortages. He's been diligently plugging away at measuring the scope of the problem, spending lots of grants to define a critical medication list, and extensively collaborating with researchers in the U.S. where there has been a matter of national security for their drug supply.

They actually defined “critical inputs”, which I'll just end with here. They defined what the critical inputs for hospitals would be very early on and very clearly in the pandemic, and that included things from drugs to PPE to even oxygen.

As I said, something has to be done. We do have a number of points, and I'd be happy to elaborate.

[The Chair, Liberal, Sean Casey]

Thank you, Dr. Ahmed.

Finally, we have Gerry Harrington, senior adviser with Food, Health & Consumer Products of Canada. Welcome to the committee, Mr. Harrington. You have the floor.

[Gerry Harrington, Senior Advisor, Food, Health & Consumer Products of Canada]

Thank you, Mr. Chair.

Good afternoon, members of the committee.

My name is Gerry Harrington and I am the senior advisor at Food, Health & Consumer Products of Canada, or FHCP.

FHCP represents the companies that manufacture and distribute the vast majority of essential products found in Canadian households, including the children's pain relievers we're here to talk about today.

For Canadian families who have endured more than two years of the pandemic with school closures, illness and ongoing disruptions, the shortage of children's pain relievers has added to their anxiety. As a parent, I understand how stressful the situation is. However, I would add that the current shortage of these medicines is an unprecedented event in my 30 years in this sector, as is the level of mobilization across the industry to try to address it.

The major manufacturers of these medicines planned for higher than normal demand for these products in the 2022-2023 cough, cold and flu season. This forecasting was done with various factors considered, such as the severity of the cold and flu season in the southern hemisphere earlier this year, the expected prevalence of COVID in the community as we went into the season and the state of public health measures in place that might influence the spread of infections. Based on those forecasts, the production and allocation for Canada was increased substantially.

However, the infections came early. By late spring, as you've heard previously today, rates of respiratory infections in children were already far ahead of expectations and out of season, putting pressure on inventories just as they were being replenished. In August, a hospital's decision to require prescriptions for children's acetaminophen that had been compounded in their own pharmacy was widely misreported as applying to all such products being sold in community pharmacies. This, of course, caused an understandable degree of stockpiling by anxious parents. Indeed, demand spiked to three or four times above normal levels, quite quickly emptying supply chains and store shelves which, in turn, spurred more panic buying.

This has happened within the context of supply chains already being stressed and business still not being back to normal in our industry. Our member companies continue to face unprecedented and ongoing supply chain disruptions, including complex factors like transportation disruptions and delays, rising costs and shortages of inputs and labour. Despite these challenges, the manufacturers of children's pain relievers have already ramped up production to 30% to 40% above historic highs and plants are operating 24-7 as we speak.

Replenishing empty supply chains on the fly is always challenging, but as you know, the number of respiratory and virus cases has continued to climb through the fall, pushing ERs and pediatric ICUs well beyond their capacities, as you've just heard. Manufacturers will continue to work around the clock as long as this demand level continues.

It's important to understand that this outbreak of respiratory infections is a global phenomenon. Since late winter, sporadic shortages of these medicines have been reported in France, Ireland, Pakistan, Germany, Malaysia and Japan. Since this summer, industry has looked for opportunities, in spite of those pressures, to supplement Canadian production and allocations with new allocations from global supplies, but those supplies are tight.

As early as this summer, Health Canada was signalling to our members that it was prepared to offer regulatory flexibilities that would allow manufacturers to boost production or imports as long as these did not compromise consumer safety. Those flexibilities permitted two proposals for imported products directed to hospitals to be approved last month, as you are all aware, and I'm delighted to note that more recently we've had another proposal approved for a shipment of children's acetaminophen intended for community pharmacies within weeks.

In all three of these cases, the degree of supportive collaboration offered by Health Canada played a critical role in these successful outcomes, and I want to underline that. I want to emphasize that numerous manufacturers continue to explore opportunities to bolster supplies and are in regular contact with Health Canada to that end.

We believe these efforts will result in a marked improvement in access to these medicines in the coming days and weeks. That said, we still have no clear line of sight of the day when the number of these viral cases begins to normalize and demand for these products returns to something resembling normal. That remains, above all, the public health issue for all of us to address collaboratively.

Thank you. I look forward to your questions.

[The Chair, Liberal, Sean Casey]

Thank you, Mr. Harrington.

We're going to begin the rounds of questions now, starting with Mr. Jeneroux for six minutes.

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

Sorry; it's going to be me, and I'm going to split with Dr. Ellis.

Thank you, Mr. Chair, and thanks to all the witnesses for being here.

We heard from Health Canada that they actually were aware of this issue in the spring. In their mind, it only really became an issue when it was publicized in August, and basically only after we started bringing it up in question period did we actually see any movement from Health Canada to publicly address this issue.

I know as a parent that the worst thing in the world is having a sick kid. No one wants to bring a sick child to the emergency room just because they have a fever, yet I'm seeing countless reports of that happening because there is no other option, especially in many of our rural and isolated communities that don't have 24-hour compounding pharmacies and the families don't have the capacity of having this medication on hand.

Ms. Gruenwoldt, can you describe how many families are presenting simply with a fever at some of your hospitals just to get Tylenol or Advil and then going home?

[Emily Gruenwoldt]

Every single day now for several weeks, our emergency departments across the country are seeing these unprecedented demands. You heard me speak of capacity well over 100% very consistently from coast to coast.

I think the hard truth is that we have an undersized health care system to serve a growing number of children and youth in this country. Gaps exist in the community for families to access primary care services. The gaps that we're seeing in community hospitals are a result of some of the challenges they experienced over COVID in losing pediatric beds and losing highly specialized pediatric care providers. We're now seeing the impact of that, because families have nowhere else to go, so they are showing up in the emergency departments in unprecedented numbers.