S04 E05

Bringing Rare Disease Therapies into Canada


Bob McLay
Vice President & General Manager
Sobi Canada

In the fifth episode of our fourth season, our host Peter Brenders talks with Bob McLay, Vice President and GM of Sobi Canada, about developing and manufacturing innovative therapies for rare disease, Canadian rare disease policy and Canada's funding model for precision medicine.



From the National Pharmaceutical Congress, this is the NPC Podcast for May 26, 2021. The NPC Podcast was created to discuss and consider the purpose, process, and people of the pharma industry during the year of Covid. And today, we're continuing the health care conversation by answering questions from listeners, just like you. 


This program is presented in cooperation with Impres, Canada's next generation commercial partner. The industry is rapidly evolving, and Impres is designed to help you evolve with it. Learn more about Impres, tailored best in class solutions at www.impres.com.


On today's podcast, our guest is Bob McLay. Bob is the Vice President and General Manager of Swedish Orphan Biovitrum better known as Sobi Canada in Oakville, Ontario. He'll be speaking with our host Peter Brenders, but first to spin the platters and make the chatter is Mitch Shannon, CEO of Chronicle Companies. Mitch, will you play something Bob for us?




Liona, I'd be pleased to. Let's get right to our musical introduction of today's guest. 


*music plays*


That was a double down dose of Bob. Bob Dylan who turned 80 years old on Monday, name-checking Bob McClay, who's a good five or ten years younger than that. Here's Bob McLay, a friend of this program in conversation with Peter.




Welcome to the NPC Podcast. I'm Peter Brenders, your host. In our continuing look at the purpose, process, and people in pharma in Canada, this episode takes a look at the challenge in bringing therapies to Canadians in need. 


Joining us today is industry leader Bob McLay, Canadian General Manager of Sobi. Welcome to the NPC Podcast, Bob.




Thank you, Peter, it's a pleasure to talk to you today. And thanks for having me on.




So, I'd like us to start with a little bit of context to help our listeners understand the perspective you're going to be bringing us from Sobi. So maybe you can give us a little overview of what Sobi is.




Sure. Sobi is the largest biotech company housed in Sweden, got an office in Boston, and also an office just outside of Toronto, been around for over 40 years in various forms. But the focus has always been on developing and manufacturing innovative therapies for rare disease patients. Our company tagline used to be "pioneers in rare disease," but we evolved that to "leaders in rare disease." So that's a place we play and that's what we hope we bring value to people.




Okay, so let me take our conversation a little bit beyond just rare diseases. And so maybe give a little context further for folks in terms of how companies like Sobi bring products to Canadians. 


You're one of the early GMs of Sobi, you really were the guy that has helped building out the Canadian operation. So what does that involve? The companies need to invest much to start a company to bring treatments to Canadians?




You know, there's a lot of behind the scenes work that most people don't know about. It's not just a matter of, you know, pressing pills and mailing them into Canada and having to sell them. You know, there's lots of things to do. You know, fees to Health Canada for regulatory reviews, you got to think about setting up importation licenses, drug establishment licenses, pharmacovigilance, quality systems. You know, there's a global value dossier that we have to adapt to the Canadian market, which really means, you know, what kind of value are we getting for money. There's fees for health technology assessments with CADTH and INESSS, you know, building up various other systems like third party logistics, distribution, often there's expensive patient support programs to help patients navigate through some reimbursement waters, price negotiations, provincial product listing agreements. All that background work takes a lot of time, energy, and resources. And you know, sometimes you have those resources here in Canada, sometimes you outsource them. And sometimes you use your global contacts, your global colleagues, but you know, a lot of work, a lot of investment even to come to Canada. 


See, I would say, you know, you're looking at multi-millions of dollars even to get off the ground here in Canada. And you know, whether you like this or not, it is a business and we've got to look at return on investment, but even return to breakeven, you know, thinking about all the costs that come here. So, sometimes you see where products aren't available in Canada for various reasons. And some might often wonder why, especially in the rare disease space, where, you know, there may be very few patients, very few treatments, and companies will often be leaned upon to bring those in. And sometimes it's not even commercially viable. But there's ethics there, and we often do try to bring them in as best we can.




What about companies working together? Can companies come together in some way or form to help make a difference in the policy environment?




Well, there's lots of industry advocacy groups, there's Innovative Medicines Canada, Biotech Canada, Life Sciences Ontario. And there's another group that I work with, I actually chair, called RAREi and its rare innovators, and this group is 13 companies that primarily work in the rare disease space. And the need for this group to come together was really, you know, we focus on rare diseases, all of us are challenged by the policies in Canada for rare disease patients. So we really need our own voice. 


We really need to, you know, to find a rare disease policy. Find a way from a regulator standpoint or a reimbursement standpoint to, you know, put a policy in place that allows government officials to have a lens to look at rare diseases and rare disease therapies properly. Because right now we don't have that. And the big industry groups are great, certainly well resourced and do good things. But rare innovators, if we can't have a policy where rare disease products can come here, and we know we're late, we know we're delayed. We know rare disease patients don't do as well here in Canada. 


So we really need to push that policy and having a rare disease policy, I think, is important, a different way to improve these drugs and get them put through the system. Because right now is not working for patients.




Maybe we'll come to the ethics question in terms of actually bring in treatments to help Canadians, but I'm listening to you and I'm thinking that's a pretty huge commitment just to set up a business, you're talking multi millions of dollars to invest to bring a treatment. To your point, whether it's a small rare disease treatment, or a large mass market treatment, it's still, we're talking about millions of dollars of investment. 


Let's talk a little bit about sort of the environment that is candidate then with that commitment. So you know, what's it like? I mean, you've been in this industry and working at it for over a couple of decades now. And so I'm interested in your perspective as how have things changed over the years?




Yeah, you know, I came in, I guess, during what one would call the blockbuster era. So you know, big drugs like Viagra and Lipitor, things that the lay public would even know about. And that was, you know, those are mass market products, a lot of people with, you know, hyperlipidemia, or, you know, high blood pressure or depression, some of these big drugs, we all remember those, those big blockbuster drugs, and a lot of those went generic. 


And I remember years ago, early in my career, I was thinking, you know, when all these common diseases, all these patents are gone, and all these drugs, where's this industry going to go? Am I gonna have a job, you know, 10-20 years from now. And you know, from that, it became things like biologics, things like precision medicine, you know, for cancers, for rare diseases. And the technology is just incredible today on what we can do, but you know, I was at a conference a few years ago, and one thing that someone said was, we've got all this great technology, we really push science in a very high way. But we just haven't figured out a good funding model for that, because it's expensive to get these therapies, it's difficult to do the science. And these are all highly educated people who get involved in this, and we have to pay them, there has to be some way to have that distribution of resources to get to these folks. 


So you know, I guess it's changed that way from blockbusters, big products, common diseases, to really precision medicine for individual patients, and we always knew it would go there. I just don't think we figured out the perfect system yet. And no country has a monopoly on that, no system is perfect. You know, US, Canada, European countries, everyone struggles a little bit with how we resource this.




You're listening to Bob McLay, Canadian General Manager of Sobi. 


I get that we're doing more niche products than what we've done in the past. But what about the Canadian environment? Is that just as easy? Or is it just as hard as it's always been? Has our environment changed in terms of bringing these products in?




When I started as a GM of a rare disease company, you know, I was networking with other GMs of rare disease companies. And one of them said to me, you know, being a GM in Canada in rare disease, you're not going to be a star. On the global stage, you're going to really struggle here, you've got to fight for every patient, funding isn't easy, we don't have a rare disease policy here in Canada. The lens by which, let's say, Health Canada, the regulator, looks at these drugs, the way that, you know, the health technology assessment groups, look at these drugs, they have a lens of common drugs. Even the common drug review, it's called the common drug review. So how are they supposed to look at a rare disease drug and the metrics they use, the measurements they use, it really doesn't lend itself to being very successful at getting innovation here for Canadians with rare diseases. And you know, one thing I've said over the years I've done this is, I think Canadians would be mortified if they really knew how rare disease patients and families were treated in this country. 


I did a talk at a CORD conference. So Canadian Organization for Rare Disorders, a few years ago, and, you know, I got up and gave a talk about bringing innovation to Canada and some of the challenges of that. And at the end of the conference, there was a Q&A. And a mother stood up and was at the microphone. And she was directing the question to me, and she seemed quite cross, and I thought, “oh, boy, what did I say, what a stupid thing did I say or didn't mean to say?” But she said to me, “you know, you're in a position of power, you run a drug company here in Canada. She says, I'm just a mother. So you better keep fighting for our patients, fighting for our kids, because we can't do it. You're the one that can can help direct policy, you're the one that can deal with government. So you need to keep doing that.” 


So I took that very seriously. That is part of my responsibility, which is why I spent a lot of my time looking at policy, working on policy, trying to advocate on behalf of rare disease patients, because by nature of rare disease, there's only a few of them. You know, they don't have that big lobbying voice. They don't have that big clout to go into the government and say, we need help here. A lot of people don't understand, Rare Disease don't understand how patients are treated here. We take great pride in our healthcare system in Canada, and for the most part, it does pretty well. But with rare disease patients, it really doesn't do well at all.




It all sounds theoretical, it's very difficult. Is it really that difficult? I mean, are there real stories out there of struggles?




So imagine you have a child, and this child through a newborn screening test is discovered that they have a rare metabolic genetic disorder that's life threatening. And fortunately, for this family, there's a product out there, a drug out there that's available that arguably could be life saving, and based on the literature, based on the history of this disease, this drug, you know, for all intents and purposes is a life saving medication, along with dietary restrictions and so on. Get the newborn screening, you understand there's a treatment, and you start working through all of that, and the child is doing fine on treatment. And then you get a letter from a government official at the Ministry of Health saying, we're not going to fund the drug anymore. You might want to contact the manufacturer for samples. 


When I heard that story, I just thought, imagine the stress that that poor mother went through, that family went through, when everybody knows, the doctors know, the nurses know, everybody knows that you need this drug or your child may not live. And the government sends you this insensitive letter saying we're not going to fund it anymore. The parent didn't do anything, the child didn't do anything. And it was just because of a, you know, game that was being played to try to reduce the price of the drug. You know, I was so infuriated by that story. I just thought that is, that's a great example of where, you know, we did not do right, as a country by that mother. We put her in a situation of absolute stress and anxiety and hoping that the whim of you know, some drug executive is going to say, “yes, I will allow your child to live. So I'm going to give you free drug.” I approve free drug all the time, and unfortunately, I have to do this. And sometimes you feel like you're playing God because governments aren't going to pay for it. Someone slips through the cracks. And there's no other means by which this patient can get the product. So they come to me and say, “will you give free drug to this patient?”

The one this morning for me was someone who'd been on long term steroids, high dose steroids, and that's terrible - degeneration of joints, everybody knows you're not supposed to be on steroids long. So either I can say “yup, keep that person on steroids.” Or, “you can have my drug for free.” So I don't like being put in that position. It's not fair. To me, it's not fair to that family. But that's the system that we rely on. And government sometimes rely on our generosity to give away drug for free. There's no other system by which that can happen.




But is this unique to rare diseases, though, Bob? I mean, or is it something more systemic?




My place has been in the rare disease phase for the last five years, but certainly other colleagues that I interact with, interface with, there's pressure all around a new regime and price controls here in Canada that's causing a lot of stress and anxiety, even bubbles up to popular media sometimes. 


But yeah, PMPRB is something that's really created a lot of trouble. It just becomes very unpredictable to run a business here in Canada. When I go to the people I deal with in Boston, my bosses or the people in Sweden, and they're trying to understand, you know, how much product do we need to make? What kind of inventory do you need? What kind of price are you going to get in Canada? How much revenue, how many patients? It's completely unpredictable, the timelines are long, you never know what the answer is going to be. It's a rats nest to get through all the rigor and regulation here. 


So you know, certainly for rare disease, it's tough and probably even tougher, because you've got so few patients, and are you going to get coverage or not coverage, I don't know. But some of the bigger products, bigger drugs, bigger companies, we're talking about, you know, a lot more investment, a lot more dollars. And when it's that unpredictable for everyone, it just makes, it makes life very difficult in Canada. And you know, I remember in the old days, you know, Canada would be a tier one, tier two kind of country to bring products in. I think we're being relegated to the, you know, tier three, tier four, like Russia, or Slovenia, areas like that. Again, we take great pride in our healthcare system. And I don't think we want to be relegated to playing in the same field as those countries that maybe we should be ahead of.




You're listening to the NPC Podcast, I'm Peter Brenders, your host. 


So, take me through that challenge though, how are you explaining this to your global parent company? How do you keep them interested in Canada?




Well, I try to paint it as not a rat's nest or horror story. I try to paint it as a great place to do business because I have employees that I want to maintain them, keep them employed, you know, and I care about the patients. That's what keeps me going. So I try to paint the picture to my bosses that Canada is a good place to do business, while at the same time, you know, I'm like the duck on the water. I look calm and cool and collected on the top, but my feet are spinning underneath me, because I just don't know. 


So I don't want to sound the alarm, you know, make it sound like it's terrible here in Canada, when they might say, well, maybe we should pull back, maybe we should not bring products there. Maybe we should relegate you to third, fourth, fifth tier country, because it's not worth our resources. Because we don't think we'll get anything back from that or it's just too difficult, or the timelines are too long, or it's too unpredictable. So I try to put on a brave face with them and try to paint a rosy picture. But there's just a lot of uncertainty and that's very challenging. 


So I almost sometimes feel like I'm putting myself at personal risk for my own career, when you know, I just don't know what's going to happen. And if I can't steward these products into the country, get them into the appropriate patient and make the system work, a lot of small companies don't survive. And you know, I came in here, we were very small. We had six people, you know, I've done my best to make sure that we keep this company going here in Canada, and we've got a pretty good future as long as, you know, we can get approvals, we can get reimbursement, but that's pretty unpredictable. So I'm hopeful. 




The federal government's budget had promised a billion dollars for rare disease treatments. How's that gonna play out?




Well, I know how I'd like it to play out. I would like that billion dollars to help patients, you know, be earmarked for patient care, to be earmarked for new innovative treatment, because there is a massive unmet medical need for many of these patients. And a lot of them are children. So a lot of families are very much effected. And, you know, we see the delays, we see the gaps, where other countries get these products, you know, months or years, often years ahead of when we do. 


And imagine, again, you have a child who has a rare disorder, you know there's a therapy available in the US or somewhere else, and you're waiting and you're waiting, you're calling the company, you're calling the government, you're doing everything you can, yet our system is not really patient centric. You know, in Germany as an example, when a new product comes out, it's instantly approved, instantly paid for by the government. And then what they do is a year later, they say, “okay, let's look at what that price was, let's look at what the real world outcome was. And we can decide on, you know, was their value for money there, was there a reasonable price, and let's renegotiate at that time.” 


So that's really putting that patient first, especially in a rare disease situation, massive unmet medical need. Here, again, we're relying on, you know, samples maybe having to come into under a special authorization program. It's not that easy. So again, if I had a child with a rare disease, I would be very afraid here in Canada, because you just don't know what's going to happen.




I hear the challenges with government, but let's, you know, sometimes we got to solve our problems ourselves. So you're doing a lot. You talked about policy, the work you're on there, but what's the industry doing about all of this?




Yeah, industry has long tried to have a relationship, you know, with regulators, with policymakers, payers, because I think that partnership and collaboration is really in anything in life is the best way to go. And it's been quite an antagonistic situation, you know, there was a proposed rare disease policy penned probably 2015, little bit before I started into this, and, you know, it sat on a shelf, sat on a desk, and nothing really happened. 


So industry gets a little bit frustrated, where we're trying to reach out, we're trying to collaborate, but we just don't get anywhere. And you know, through the last five and a half years that I've been doing this, I've met with, you know, the head of Health Canada, the head of CADITH at all these different organizations. And largely, they're good people. And I like interacting with them. They're well intended, they want to help, but they all have their own lane, and it's hard for them to go outside of that lane. You know, "I'd love to help you, but that's not my area, or we'd like to make an exception, but we just can't in this case. And oh, that was an unintended consequence of that policy." I've had all of these things thrown back at me when all I'm trying to do is the right thing, to get the right product in a patient that needs it. 


So I don't necessarily blame the individuals, they're stuck in the policy that they're dealing with. So there isn't that overriding collaboration, cross functional, all the different groups, all the different parties at the table at the same time, and whether the system is set up that way to block and delay, I don't know, but it certainly seems that way sometimes.




So what counsel or call to action would you like to make to the broad Canadian community? How do we get on top of this?




The vaccine situation with Covid has, you know, sort of earmarked or highlighted the challenge there. You know, I think we all as Canadians saw a bit of a mad scramble. Getting vaccine or we're not getting vaccine? Every day in the newspaper, you read something different. And you know, I think we're coming around better now. But at the beginning, it didn't look very good. And you know, from an insider's standpoint, I just thought, does the government even have any relationship with anyone in industry? Are they scrambling now to try to make friends and see what we can do? 


So, I think that really highlighted the need for, you know, public health policy, that is, you know, cooperative and collaborative and good partners with any industry, I don't care if it's pharmaceuticals, or tech or what, but you really need to know people have those relationships, to be able to make decisions quickly and get things done. One thing I saw, which, again, I didn't like. I saw a politician on their Twitter feed showing off that they were getting the vaccine. And here's someone very, very anti industry. They're so proud to get this vaccine. And you know, no talk about how much it costs or anything like that. I'm thinking I'm a rare disease patient, and I can't get my drug. Here you are, who is very anti industry, you're happy to get the innovation, happy to get this technology, yet I'm a rare disease patient, and I can't get mine. It really rubbed me the wrong way. I thought that's just not, this is not fair. 


Yeah, the vaccine situation I think has highlighted the need for better collaboration, better cooperation with industry, so we can act quickly. And, you know, address the unmet medical need in a well thought through manner versus scrambling and spinning.




So I think that's a great way to wrap this up as we need to find some collaboration, a way to work that we're talking together that at the end of the day, we don't find ourselves in the crisis we are at at the start of this pandemic, where we just didn't have the supplies or the interest or the enthusiasm for the industry that can make a difference. 


We have been speaking with Bob McLay, Canadian General Manager of Sobi on the NPC Podcast. Thank you for listening.




Thanks to Bob and Peter, check out Sobi at www.sobi-northamerica.com. That's S O B I dash north america.com. 


If you have comments or questions about today's conversation, or you're just dying to say hi Bob, you've got lots of ways to connect with us. Tweet us @2021NPC. Send us an email to health@chronicle.org. Attach a voice clip to your message and, you know, you might just hear yourself during an upcoming episode. And our comment line is always open 647-873-6995. 


We're a month away from the National Pharma Congress Summer Webinar, which takes place at 11am Eastern Daylight Time on Tuesday, June the 22nd. Our guests will be Brian Canestraro of Intercept Pharma, Melissa Koomey of Gilead Sciences, and Ronnie Miller of Roche. On the theme of Countdown to Pharma's post-Covid era, Ben Perry of Pangaea Consultants will moderate, and I'll be there to keep a watchful eye on Ben in the panel. Sign up at www.pharmacongress.info, it's a free event. 


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This is Mitch Shannon of Chronicle Companies. Your Podcast Producer is Jeremy Visser and he's assisted today by Aria Empakeris. The announcer was Liona Bobbitt. The musical theme is performed with gusto by the NPC Podcast Orchestra under the direction of Maestro Hakim Milbrook. 


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