S02 E08

Canada as a Critical Market for Pharma


Mike Cloutier

Founding Partner

Accelera Canada

In the eighth and final episode of our second season, Peter Brenders, CEO of the New Brunswick Health Research Foundation, talks with Mike Cloutier, Founding Partner of Accelera Canada, about the Canadian regulatory process, hybrid market access and opportunities for foreign-based pharma companies.



Thank you for downloading the NPC podcast from the National Pharmaceutical Congress for December 9 2020. This program is all about discussing and considering the purpose, process and people of the pharma industry during the Age of Covid. Today we're continuing the health care conversation by answering questions sent by listeners like you. 


This program is presented in cooperation with Impres, Impres best in class commercial solutions offered top line and bottom line growth with maximum sales force, flexibility, speed and efficiency. Learn more about their next generation commercial model at www.impes.com


On today's podcast, our guest is Mike Cloutier, a founding partner and business development lead of Accelera Canada in Toronto. Coming to you today from chilly Fredericton is your host for today's podcast, Peter Brenders, CEO of the New Brunswick Health Research Foundation. 


But first, here's Mitch Shannon of Chronicle Companies.




Thanks, Liona. 


Well, it's amazing to me, but this will be our last podcast episode for 2020. I think we'll be glad to see the last what has been a difficult time for most of us with way too many challenges. Not that there weren't challenges for Life Sciences companies in 2019 or before that. 


But as a new year comes into view, it's fair to ask, what will Canada look like as a pharma market in the years ahead? Will we remain a leader in the life sciences as we've always been? Or are we destined to be regarded as an outpost where you need to deal with 13 different and disconnected regional fiefdoms each self-referential and adversarial to one extent or another. 


This week's guest Mike Cloutier has run seven, count them, seven pharma companies in Canada and he's the founding partner of Accelera, which provides services to offshore companies considering entering the great white north. Here's Mike 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, this episode explores the challenges of a changing perception of Canada and the implications for new treatments for Canadians. 


Joining me today is seasoned pharma exec Mike Cloutier, founding partner of Accelera Canada. 


Welcome, Mike.




Thank you, Peter. Great to be here today with you and to spend a little more time together, I always enjoy all of our conversations.




Well, let's jump into this one. So pharma in Canada is going through some unprecedented times with Covid and new federal regulations from the PMPRB. And as much as companies continue to work hard to bring new therapies to Canadians, it seems to be getting harder and harder every day. One has to wonder where this will lead. 


Mike, your business Accelera has been a go-to market resource for many international companies thinking about bringing treatments to Canada. And yet it's been suggested that Canada might be losing its luster. What are you hearing?




Yeah, approximately three years ago, we set out to engage foreign based pharmaceutical and biotech companies to accelerate the availability of innovative products to Canadian patients, caregivers and healthcare professionals by offering the only true one stop fully integrated solution. 


We've enjoyed success demystifying the Canadian market opportunity and striking down many misconceptions and myths that have pre-existed. That said, pricing remains a significant concern. And the recent proposed changes with PMPRB are creating a new round of concerns. 


The conversation is really always about priorities and risks involving the impact of launching in Canada, and what that will have- the impact that will have on other markets. Our goal has always been to ensure that the leaders in the US, in the EU and even in Asia Pacific headquarters are fully informed of the options that are available here. So we recognize that there is both an art and a science to successfully launching and that's our mandate, we partner to develop more optimal strategic solution.




So you guys are helping companies, I get that. But in a nutshell, are companies worried about Canada? Or do they think it's still an opportunity, they just need some help to figure out how to do it?




Yeah, I think they see it as an opportunity, but they are worried, there are concerns that pre exist and there are concerns that are that are even evolving, you know, as we speak. And so that's been our goal, is to have a a calm and professional conversation about the realities of what's going on in Canada and then, you know, to sit on the same side of the table with them and start to work towards solutions and you know, those solutions can be varied. 




Okay, so as a country we're sending negative or conflicting signals, which can't reassuring. So you guys are trying to help them change that. So you said solutions are varied, so give us some examples in terms of how we're promoting Canada as a critical market.




Yeah, I mean, critical questions, Peter, and thanks. 


So let's start with you know, so why would you come to Canada? First of all, Canada is a top 10 market, it is likely to remain a top 10 market that makes it an important market to be in. 


Secondarily, we have a very competitive, accessible regulatory process. There is a dated perception that we are a second tier country in terms of our regulatory process. But that's really no longer the case. We have very competitive review times, we collaborate with other international jurisdictions to leverage work done elsewhere. We offer both priority reviews and conditional approvals to accelerate access, as well as very expeditious review times for devices. 


Thirdly, there are opportunities for hybrid market access that really are not very well understood outside of our borders, the private market allows early access for some patients while we navigate the public access process. Advocacy still works in Canada, if there is a compelling unmet need, we can take advantage of that. Getting astute advice early on, about how Canadians price how it works in our system, and how that lines up with international pricing is key. 


And then fourth. And finally, the opportunity and specialty markets. Key thought leaders are accessible in Canada and connected given the very nature of the centers of excellence around the country, then the national associations and a very urban population. When companies engage our KOLs very early and keep them well informed, we can very quickly cascade adoption through all of the community specialties and really coast to coast to coast.




I hear four good arguments and in terms of word Canada has a value in it. And if I'm the government, I'm listening to a couple of those arguments. And I'm very excited about it. And so I'm very confident in my approach to manage pricing because you're a top 10 market and we have great access. So of course, you're going to bring your product here a company and so stop your whining about all this pricing. 


But on that pricing. Let me ask you a sort of challenge question back we have hybrid market access, but that all presumes that a company can sell a product at a price that thinks is reasonable. If the government doesn't agree to that, are these PMPRB reforms make Canada unattractive? Does that undermine everything else?




it can potentially undermine access for a great number of innovative products. There are ways and means in very specialized niche markets and opportunities. There are you know, rare and orphan opportunities. Also, there may be the ability to garner a price that goes outside of what many other traditional products will be considered even in the new regulations. And you're right I mean, industry, all stakeholders, patients, caregivers, health care professionals, everybody involved in the in the system needs to continue the conversation with the federal government about these proposed guidelines and about any alterations that can be made to ensure that we stay price competitive. 


But there is one thing that we need to consider if you look at the current situation worldwide. And for example, if we were to take Germany and the UK, and to look at the Canadian pricing in respect of the US, those two countries in Europe and ourselves, we're not so far beyond Germany in the UK right now. With the removal of the US and Switzerland and the addition of these new countries, we could dip to those levels or maybe even slightly below. But I guess my challenge back to our partners outside of Canada would be is that going to make us so price incompetitive compared to those other jurisdictions that you would also consider not going to Germany or the UK? 


I mean, I think we need to balance the discussion and the argument. And I'm not suggesting that we ever lead up. I'm not suggesting that we don't continue to challenge the federal government and make sure that they understand the risks that are putting us out. But we do also need to understand that international partners, they need to also understand the opportunity in the context of other opportunities that they never consider opportunities they wouldn't do.




You're listening to the NPC podcast, our guest today, seasoned pharma executive Mike Cloutier, a founding partner of Accelera Canada.


I kind of hear like this Shakespearean quote "me thinks she doth protest too much." 


So to your point that Canada is still a good market, our prices are not out of line with other major markets and therefore we shouldn't be quite as worried about PMPRB as we think about on average? Or are there some really special cases that would make it horrible for patients and I'm trying to get a sense on what do we really look like? 




I think that will only be determined as we proceed with the new guidelines, I would say that there are going to be circumstances where companies outside of Canada are going to choose not to come to Canada, I'm hoping that those would be relatively small in number. And I hope they are unique, only because it would be disastrous and unfortunate for Canadian patients, for caregivers, and for healthcare professionals to not have access to these medications. And we're going to have to find alternative solutions for those opportunities. 


So let's park that for just a second because I would like to come back to the alternatives. But I think until we know the true impact, we do need to be cautious about how negative a picture we present about Canada, until we know for certain. I would hate for us to be scaring foreign based innovators from coming to Canada purely on the basis of speculation. And well, as I said, I agree that there will be circumstances let's make sure we fully understand it. 


But I will come back, Peter, to my point that we need to negotiate, we need to continue a dialogue with the federal government about the potential of these changes. And if we don't closely monitor, Canadians will be put at risk. And I hope that the federal government understands that I hope that is not draconian, in its approach to say, "well, you know, we just need to ensure the cheapest prices", without really considering the impact of that. And we all know, we could go on for days about the real impact and the real access issues.




So let's think about sort of that positive direction then. So rather than wait for these international companies whose global launches to come here, what are some solutions like in terms of getting these new therapies to Canadians?




The best place to begin, Peter, is sort of the process we undertake. And when we sit down with external clients, the first step we take is to try and make a high level assessment of what the potential opportunity for the product will be, and then provide them with the data necessary for them to decide what is the best model to follow? Do we set up a subsidiary, as many traditional organizations have done in the past? Do we look at some kind of hybrid opportunity for partnering where we find a way to ensure that the product comes to Canada, but we don't make the necessary investments that traditionally a company would make? And we look for partners to help us do that. And we've provided that value to some of our clients. 


Or in reality is the best alternative just to license this product to an you know, a partner already existing in Canada and say, "hey, look, you guys are going to have to make this work and we're going to have to be, you know, third party removed from that", which isn't the most elegant solution. But given the resources issues that many of our clients face, sometimes that just happens to be the alternative. And then you know, it's a bit of a cat and mouse at that point, right? It's not necessarily a very transparent and elegant solution, but it is one that removes the name of the company associated with the product, which can provide some cover. 


But the reality is that we've had a couple of conversations of late with potential clients who, in their words, not my words, in their words have said, "you know, realistically, how can we be on this side of the border, and not have some societal obligation to bring this product to our neighbors in North America, we share the same landscape, how can we not find a way to bring this product to Canada in some form." 


And I'm encouraged by the fact that people feel an obligation to ensure that this innovative healthcare solution does get to Canadians. But I recognize and fully appreciate that there are going to be issues that they're going to have to manage with their board, with senior management around implications of a product being priced at a certain level on this piece of land, as opposed to that continent over there. In Germany, in the UK, in Europe, right? I mean, I get, and it's just part of a dialogue, you know, we have to have a mature, intelligent, unemotional dialogue about how do we do this.




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


That raises two questions my mind then so the first one I'll throw at you is when you talk to those potential clients that are outside of our border. And you talk about how they look at across the, you know, just sort of across the border sort of South looking north. Does the issue come up in terms of a pricing differential become a serious issue to the point as much as they may ethically sort of say like, "how can I not launch just north of the border when I'm selling it here and helping patients here"? But how much is the pricing differential come into play even though our guidelines might not consider that?




And I again, we've spoken with clients who are really wrestling with this. And then these are good people who really are genuinely concerned for the well being of potential patients and caregivers in the healthcare professionals' interest to prescribe, but at the same time realize that they have a significant market in the United States, one would argue the most important and critical market, like most companies, or at least 60%, to maybe 80% of their global business, can be in the United States. And if they believe that there's anything that could happen in Canada, that might negatively impact on their business, they need to be concerned for their shareholders and for their stakeholders. 


But all too often their concerns are not based in realistic issues in reality. For example, there are issues that are raised around, you know, cross border transportation of product. Well, we all know that that's impossible. And then it never happens. Is it a possibility? In a very remotest sense, it may happen. Is it a probability? Zero. We know that that's not going to happen. 


Secondly, are the prices in Canada going to be used in the US in some formal mechanism to lower the prices in United States? I'm not aware of any mechanism that exists. In fact, the prices for some products in the United States that are available, certainly through the VA, for example, are actually lower than the prices in Canada. And so it's just a matter of having these conversations with people and explaining it to them. And if they're motivated, to be truly a global organization, and to be, you know, a company that believes that they are creating value outside of just the United States, then usually we win in those arguments, and then we go to, okay, so we believe that this product should be available to Canadians, what's the best way to go about it? You know, we have limited resources we have, that's not just money, it's time, it's effort. So what's the best way to proceed? 


And that's really, that's what we do. That's our business, our business is to collect data with a very unique modeling system that we have that's not available from anyone else. We show that to them. They're excited by it, and then we can work together.




So let me ask a related question, then terms of that north/south piece and sort of think about the upstream implications. So as much as you say, companies are concerned and interested to launch a product in Canada, and are struggling to figure that out, does that also have upstream implications where they're struggling to figure out whether they even do trials in Canada in the first place? Can they if they're not sure where the future is going to be?




I think the question around clinical trial locations is far greater than just the financial implications post launch. I think that there are pressures that organizations I, you know, I was part of, you know, multinational organizations operating in Canada, but also had international posts, Latin America, Europe, other place, you know, the US, where the pressure to do clinical program work in the US and in other markets is huge and Canada has to fight constantly, you know, to make sure that we are well represented in that. 


But it's interesting, like, we try to reach back into the process as far as into small organizations who are currently in phase II, who are beginning to build their phase III protocols. And at that point, we try to impress upon them to have at least, you know, a single site in Canada, if not three, we always try to encourage them for for the purposes of the launch processes in Canada, that it would be really great to have one in Western Canada, one in you know, in Ontario, and one in Quebec, I mean, this would be the most advantageous in terms of how you partner with the clinicians down the road. 


But I mean, having that data is really, really important. But it's a struggle. I mean, and you've been there, too, you know what it's like, it's hard to keep on the radar. And it's kind of surprising, because we know the quality of the work that gets done in Canada, it's just, you know, it's so noisy. 


But the price implications are important. And that's where we always try to make the argument that if we have clinical experience in Canada, if it's clinical experience, from coast to coast to coast in some fashion, we can leverage that down the road in a way that is quite advantageous to us. And of course, it has no negative impact on the US at all.




Great thoughts. So coming up to the end of our time on this one, Mike, but I want to give you, what sort of a summary point for our audience? Key learnings key insights you want to leave us with?




Yeah, I mean, and again, thanks for the opportunity today, Peter. 


First and foremost, I think what we need to do is continue to promote the pluses of the Canadian market to ensure that leaders understand the importance and the value that Canada presents as a top tier, tier one market. We have to all do our part to strike down the myths to eliminate the misconceptions to provide logical solutions and to provide the guidance and really ensure that people understand that there are pluses and that there's a balanced view that needs to occur. 


While doing that externally, here in Canada, we need to continue to challenge the PMPRB changes. We need to continue to work to develop better policy and to ensure that affordable access exists for all Canadians. The price concerns are real, and they're justified in that, you know, it's not everything is affordable, and prices are rising. But you know, it's really important to remind Canadians that the pharmaceutical and biotech product innovations that are made available are amongst the most economical if not the most economical and efficient care options available. And we can never lose sight of that. 


So I guess finally, we need to resist government's ploy to divide and conquer, so to speak, the way that they try at times to play us off each other and to to play key stakeholders and constituents off each other, we need to, you know, ensure that we are united in the processes of developing strategies and plans to improve access to use our resources efficiently to proactively promote healthy living, first and foremost, but also, you know, to promote great innovation and access to that innovation in terms of care. 


So if we all work together, I believe that solutions are there. But I think those are the three key things that we need to keep top of mind.




Great thoughts, Mike. So stay strong. We have much to do in Canada to help Canadians. You've been listening to the National Pharmaceutical Congress Podcast with our guest today and insights from seasoned pharma executive Mike Cloutier, founding partner of Accelera Canada. 


Thank you for listening.




Thanks to Mike and Peter. 


Whatever lies in store for next year, we can all consider ourselves lucky to live in the best country on the planet. 


If you find yourself missing your NPC podcast fix during the holiday break. You can always download past episodes of the NPC podcast from Google Podcasts Apple, iTunes, Stitcher and other sites or subscribe at pharmacongress.info and get yourself set up for 2021. 


And when we're all back after the holidays remember to register for the National Pharma Congress Winter Webinar coming to a device near you on Wednesday, February 10. Watch for registration information at pharmacongress.info. 


Meanwhile, if you want to be in touch, just send a note to health@chronicle.org or call our comment line anytime 24/7, it's at 647-875-9011. 


The Fall 2020 series of the NPC podcast was presented in cooperation with Impres Canada's next generation commercial partner, learn more at www.impres.com


In Toronto, I'm Mitch Shannon of Chronicle Companies. I'd like to take a few moments to offer some personal thanks to a few people who've really made this podcast success during our first 16 episodes. 


First, a shout out to our Chronicle team for everything they do every day. 


Next Peter Brenders is truly the Foster Hewitt of pharmaceutical industry podcasts as well as the Wolfman Jack and he's a one of a kind resource in our sector. 


Tiana DiMichelle, and Will Berard of impress our outstanding partners and I'd like to thank them for very quietly and very generously supporting Sandi's Fund at Camp Liberte through 2020. 


Jeremy Visser is our talented Podcast Producer and I'm looking forward to seeing what new heights he can lead us to next year. 


Our announcer was Liona Droid Visser and she's a delight to work with. 


Sincere thanks to everyone who downloaded this podcast, offered a supporting comment or just kept up your end by working from home and looking after yourselves and your families during a difficult year. 


Have a great Christmas break and stay safe. We'll see you again next year.