Day 1 video - December 5, 2023

Day 1 - ENGLISH

Phil Azzie: [00:00:00] Good morning everyone. We are ready to begin. My name is Phil Azzie. I'm a consultant with Phoenix Strategic Perspectives, an independent research firm. On behalf of the patented Medicine Prices Review Board, I'd like to welcome you both those attending in person and those attending virtually to this consultation on the PMPRB future guidelines. The consultation is a round table designed to provide stakeholders with an opportunity to voice opinions regarding future PMPRB guidelines. There will be a session in English and a session in French. The English session will take place today and continue tomorrow during the second part of the morning session and into the afternoon.
The French session will take place tomorrow morning during the first part of the morning session.
 Phoenix has been engaged to facilitate the consultation by ensuring that things proceed in a timely manner and to write a report on what was heard. The sessions are being audio video recorded and transcribed.
 Here's how the sessions will unfold. Over the next two days, there will be a total of 34 stakeholder presentations, most of them here in person, but some virtually. The order of presentation has been set and I will follow that order and inviting presenters to take the floor. The time allotted for each presentation, including questions from members of the PMPRB to presenters, is 15 minutes. Time for questions will obviously depend on the length of each presentation, and I know presenters are mindful of that. If and when a presentation has reached ten minutes, I'll give an indication to the presenter just so that it's a sign that they can begin concluding to allow time for questions. What I'll do is I will simply stand and come to the podium. I know I'm out of your scope of vision, but hopefully you'll catch me. At approximately 12 minutes, I will intervene simply to ask if any of the board members have any questions for presenters.
 it's obviously crucial that presentations including Q&A's not exceed the time limit. I do not want to interrupt anyone, but out of fairness to all presenters, I'll be obliged to if the time limit is reached. 
This morning's session will include a short break from 10:00 to 10:30, and we may cut into that a few minutes. We'll break again at noon for lunch, and the afternoon session will run from 1:30 to 4:30, with a short 30 minute break at 3:00 P.M.. 
 I'd ask presenters if they have to set up any PowerPoint presentations, for example, but please advise Gary Warwick, who's sitting right here at the table. Also, there are participants on site who are watching the session from an adjacent room. We just kindly request that if and when people leave this main meeting room for the day, in other words, if you don't plan to return, please just inform staff so that we can possibly usher people into this room from the other room. It's now my pleasure to invite the chair of the Patented Medicine Prices Review Board, Thomas Digby, to deliver some opening remarks.

Peter Morland Giraldo: [00:03:14] Thank you, Mr. Asey, and good morning, big welcome to everyone. So this is it PMPRB round table and we're glad that you're all here. So our round table today is designed to bring diverse sectors from across Canada together for a productive conversation about the prices of medicines. And in particular, we're gathered to share our views on how this board should determine if and when a medicines price is excessive. Many of you have traveled considerable distance, and we thank you for being here, many others are online and we welcome you from your disparate corners of the country, and though you come by very different paths, you've all found a reason to care about the use and the price of medicines in Canada. So let's take that as a starting point for today, that everyone in this room and joining us online recognizes that medicines can, with the dedicated application of human ingenuity and care, can reduce or sometimes even eliminate the burden of disease and disorder. And let us do our best today here in this room, and tomorrow to help find a path by which the right medicine, at the right time, at the right price, can be brought to support the health of individuals and communities, all in the best interests of all Canadians. I want to acknowledge that I'm speaking today as an uninvited guest on the unceded territory of the Algonquin Anishinaabe people. The Algonquin Anishinaabe have been stewards of this land since time immemorial. I ask you to join me in learning about the legacies of colonialism, and I ask you to join me on the journey of truth and reconciliation of indigenous peoples of Canada.
I’m here with my fellow board members, Vice-Chair Marie Perrot from Montreal, who is a lawyer by profession and a strategic consultant in the life sciences ecosystem in Quebec and across Canada, as well as Carolyn Koebernick from Toronto, who has nine years’ experience as a Board member and decades of experience in the federal government. Ms. Koebernick provides a wealth of continuity and perspective on the history and role of this board. 
 Online, we're joined by our two newest board members, both appointed in recent weeks. I don't think we have them on the screen, but they are there, they have just received security clearance. We've invited them to observe today's proceedings in preparation for full engagement in January.  We have doctor Emily Rhiannon of Kingston, is an Intensivist and ICU doctor at Quinte Health Care, Belleville's General Hospital and before medicine Doctor Rhiannon trained as a pharmacist. Mr. Peter Morland Giraldo is a seasoned tribunal lawyer in Canmore, Alberta. Mr. Morland Giraldo, he told us this morning that his second child has not quite yet arrived, and he may be called off at any moment, but he will join us for as long as he can, and I consider it highly auspicious that Peter arranged a new birth to coincide, with the PMPRB round table, and if it's okay with it, everyone in this room will, Let's make an effort to keep that metaphor in front of mind for the proceedings.
And I myself, I am a US Canadian intellectual property attorney based in Vancouver. For 30 years, I've worked in the field of patented medicines at the very earliest stages of drug discovery. 
 So also with us at the front of the room is the leader of our outstanding staff team, our executive director ad interim, Guillaume Kier. Mr. Kier has led the preparations for today's meetings and is available with the leadership team for technical questions and perspectives on the issues before us. 
 Okay, so the board has requested your presence at this round table to help prepare the way for new guidelines, which are expected next year in 2024. And the board is here to listen to your thoughts and comments about the proper approach we should take. We want to understand your concerns relating to our statutory mandate, which is to prevent excessive list prices of medicines in Canada and to give shape to the round table, we published a scoping paper three weeks ago covering six broad themes that the board members believe are central to the discussion. And your presentations are not restricted to those themes, but let it be said that the board believes that these six themes capture much of what needs to be decided. So we have an open mind, we're willing to examine all perspectives on any of the matters you wish to bring for us. And with that, I'll turn it back to Mr. Phil Azzie to introduce our first presenter.

Phil Azzie: [00:08:28] Thank you very much. So, without further ado, I'll call on our first presenters, Michael Dietrich, executive director, policy, Innovative Medicines Canada, and Declan Hamill, vice president, policy, regulatory and legal affairs, the floor is yours.

Declan Hamill: [00:09:03] So good morning, Mr. Chair, Madam Vice Chair and member of the council. My name is Declan Hamill, I'm the vice president of policy, regulatory and legal affairs with Innovative Medicines Canada. With me today is Michael Dietrich, IMC’s executive director of [00:09:16] policy. The National [00:09:19] biopharmaceutical and vaccine organization representing the majority of rights holders subject to PMPRB’s jurisdiction. The association advocates for policies that enable the development, delivery of innovative medicines and vaccines to improve the lives of all Canadians and support our members commitment to being a valued partner in the health care system. Collectively, our sector supports more than 107,000 high value jobs, invests upwards in 2.4 billion in R&D annually, and contributes nearly 16 billion to Canada's knowledge based economy. As an industry, we're extremely proud to play an important part in enhancing the total health of Canada. On behalf of our members, thank you for this opportunity to comment on the scoping paper for consultation on the board's new guidelines. The implementation of guidelines that are reasonable, predictable and consistent with the PMPRB's mandate is a matter of fundamental importance to our members seeking to launch new medicines in Canada, a matter of concern to all Canadians, given the great value of innovative medicines to patient health care outcomes.
The PMPRB's scoping paper sets out six themes for discussion, IMC’s remarks today will touch upon the first five themes, further elaboration on all of the themes will be provided in our written submissions to the board. But before discussing the scoping paper themes, we'd like to offer three initial points for consideration. 
 Firstly, IMC notes that the current consultation is the latest stage in what has been extended in a multi-year process, sometimes difficult for stakeholders, the board and all concerned. While our members would appreciate having a new system in place to relieve ongoing uncertainty, a reasonable and appropriate outcome is more important than an outcome based on a specific time frame. In our view, getting it right rather than adhering to a schedule should be the shared objective of all concerned. 
 Secondly, and from a process perspective, IMC would recommend that in advance of the PMPRB's publishing a draft guideline, a working group with patented technical experts should be established to engage in a more iterative guidelines development process. This was the customary practice for guidelines discussions prior to 2016/2017 and these current reforms. IMC is confident that such a working group will add value to the guidelines process for the PMPRB and for stakeholders. 
 Our third and most important initial point is that our comments today are rooted in PMPRB's excessive pricing mandate under the Patent Act, the patented Medicines Regulations, and as interpreted by recent judicial decisions, the prevention of patent abuses, PMPRB's appropriate and primary role. Drug pricing regulation is the purview of Canadian provincial and territorial governments.
 Accordingly, and for new products, the highest international price for the new PMPRB 11 basket of countries is most consistent with the board's mandate. Modifications based upon the consumer price index should also be permitted, and there should be no re-benching over the patented life of new products. Additionally, given that investment decisions have been made based on existing products under the previous guidelines, these products should be grandfathered from the new guidelines requirements. 
 It has been suggested that the median would have been an appropriate level under the new guidelines, given its previous usage by the board in the context of the PMPRB's seven basket countries. However, its universally acknowledged that the PMPRB's 11 removed two higher priced jurisdictions while adding several lower cost jurisdictions, which already has the effect of constraining the ceiling price of new medicines.
 Moreover, there are significant predictability concerns given that the median now consisting of 11 nations can fluctuate greatly over the life of a patented medicine given its excessive pricing mandate PMPRB should not further constrain pricing by selecting the median as the reference point for future guidelines. It's also been noted that some patent medicines are already priced in a manner consistent with the median PMPRB's 11. However, IMC would emphasize that the issue is the appropriateness of the median as a guideline standard irrespective of any voluntary pricing decisions made for specific products in an uncertain regulatory environment. We will now offer some comments on the scoping paper scheme's themes with respect to the first theme pertaining to the potential application of previous guidelines. 
IMC would suggest that caution is warranted with respect to reusing selected elements of PMPRB’s 2010 guidelines. These guidelines relied heavily on the median in determining introductory prices, which is not aligned with the excessive pricing rule under the PMPRB 11 basket. As noted above, IMC maintains that consistent with the Act, that the HIP standard remains ­­appropriate in addition to CPI adjustments. 
 Turning to the second theme pertaining to the treatment of existing medicines, all patented medicines introduced prior to the finalisation of the new guidelines, whenever that should occur, should be allowed to retain their current maximum non excessive prices. Patentees and other supply chain stakeholders have created and executed upon business plans based upon the previous regime, and should not be penalized for the ongoing uncertainty with respect to the creation and implementation of new guidelines. With respect to the third theme pertaining to the reviews during the life cycle of patented medicines,  the scoping paper questions are very difficult for IMC to answer without more information regarding the new guideline system or the function and implications of a price review. However, and as a guiding principle, what right holders need and expect is a predictable maximum non excessive price over the life of a product subject to potential CPI adjustments. Similarly, with respect to the fourth theme of investigations and referrals to hearings, the appropriateness of the 2010 criteria for commencing an investigation cannot really be evaluated separately from new guidelines to be implemented. It's our view that the most effective price review system would consist of transparent and predictable guidelines that define price tests to be applied for medicines under your jurisdiction, if a price appears to exceed the ceiling price set out by the price tests, then an investigation should be undertaken to determine if the test was being properly applied procedural detail sufficient to ensure the principles of fairness, transparency, predictability, efficiency and voluntary compliance could be explored through a technical working group. As suggested previously with respect to the fifth theme focused on PMPRB's relation to pan-Canadian healthcare partners, payers and alignment with broader government objectives, IMC is pleased that the board is considering its role in a broader context, but also concerned that some of the questions in the scoping paper imply a role for PMPRB beyond its excessive pricing mandate. The mandates of Canada's health technology assessment agencies CADTH and Inis are separate and distinct from that of the PMPRB’s excessive pricing rule, and from the PMPRB's regulatory amendment that the new guidelines are intended to operationalize.  
Similarly, pCPA has an important but separate and distinct pharmaceutical negotiation mandate for Canadian public drug plans, a process that greatly benefits the plans through the negotiation of price reductions significantly below the PMPRB's ceiling prices, private payers also engage in negotiation processes that result in reductions lower than PMPRB's ceiling prices. IMC and its members believe that timely access to innovative medicines is a significant Canadian public policy issue. Given that our patients have less access to these treatments than patients in other G7 nations and many OECD comparator nations, only approximately 20% of new medicines launched globally are available to Canadians via public drug plans, and on average, it takes two years for these medicines to become available via public drug plans, which is twice the OECD average, this is due to many factors, including, without limitation, regulatory inefficiencies and duplication, sometimes narrow and inflexible HTA recommendations, and the applications of processes designed for conventional pharmaceutical products to complex new technologies. However, and to be clear, the PMPRB's greatest contribution to this issue would be the implementation of guidelines that are reasonable, predictable, and consistent with the PMPRB's mandate. Access and availability, together with other important government policies such as agile licensing, the Biomanufacturing and Life Sciences Strategy and the National Strategy for drugs for Rare Diseases will be enhanced and supported by a PMPRB's regime appropriately limited to instances of abuse. 
 In conclusion, timely access to new medicines saves lives, reduces health care costs and contributes to economic productivity, and makes Canada a more attractive destination for clinical trials and investments. Innovative Medicines Canada and its members hope the board's deliberations will be mindful of the impact that the new guidelines may have on access and availability, and remain guided by the PMPRB's excessive pricing mandate as set forth in the act and the regulations, and as interpreted by recent decisions. 
 Thank you to the Board panel for your time and attention. We will be happy to answer any questions now that you may have.

Phil Azzie: [00:18:32] Thank you. We do have approximately five minutes left, so I'll invite board members to ask any questions if they have any.

Peter Morland Giraldo: [00:18:38] We have five minutes, but are we doing a double session here? So we're just going to stick to the five minutes, there is a lot in that. Thank you so much, Mr. Hamill. Mr. Dietrich. So, I was right off the top, I was interested. Do you feel that we're not in a hurry to get new guidelines in place. Because you believe you'd rather get the guidelines right than rush to a clear and final decision on the new guidelines, is that correct?

Declan Hamill: [00:19:11] Yeah. That's correct. I mean, this process has been going on since 2016. So if additional reasonable time is necessary to complete the process, I think that's in the benefit of the board and it's the benefit of all stakeholders.

Peter Morland Giraldo: [00:19:25] We are aware that there were a number of comments that came in during our recent notice and comment that some stakeholders were anxious to get to clear results because we're currently in a period of interim guidelines, and there's quite a few ambiguities in that, and your members would be in a position to they'd rather not rush to a result, even though these ambiguities are known and exist.

Declan Hamill: [00:19:50] Well, I think to be clear, Mr. Chair, no businesses like ambiguities or uncertainties. That said, this process has been continuing for a long time, and it's probably better to get it right, because our hope would be similar to the 2010 guidelines, that these guidelines would be in place for a significant period of time. And therefore, you know, if some reasonable additional period is needed, then that should be something which would be deemed to be reasonable, not an indefinite period, of course, but, you know, one that ensures that all stakeholders have been heard and that there's been due diligence provided before new guidelines are, are implemented.

Peter Morland Giraldo: [00:20:28] Okay. Because we are aware that the one thing that is certain about the interim guidelines that we're operating under is that there's no penalty being assessed to anybody who happens to have a price that's found to be excessive. So we're kind of in a period of open pricing right now,  and you're okay with that? I assume until we come to finalize our guidelines that.

Declan Hamill: [00:20:51] Well, as noted, you know, within reasonable boundaries, I mean, the scoping document says it's the board's ambition to have the guidelines finalized  in next year and, and  that may be a reasonable time frame. But all we are suggesting is if that time frame, you know, needs to be altered by number of months, by a reporting period, that is, in all likelihood, the best outcome for all stakeholders in the board.

Thomas Digby: [00:21:19] I might just also add, that really depends on the complexity of the guidelines, we need more time to get into, you know, the various factors that could play in to a guideline, that if it's a higher level type of approach, then, yeah, maybe it could be done and dusted in in a year.

Phil Azzie: [00:21:37] Colleagues, have a question?

Marie Perrot Thomas: [00:21:42] Thank you very much for your presentation. As you know, I was recently appointed to the board, so I'm still learning quite a bit, even though I've been in the ecosystem for many, many years. 
The guidelines, as you know, are helping us to manage a process, right? Because only decisions that are hearing can determine if price is excessive or not. So can you elaborate on where you think the board should draw the line as to whether or not to go to a hearing, or whether to investigate? Where is it that we should draw? I would like to hear more about that.

Declan Hamill: [00:22:24] I think as we said in our remarks, it's a little bit difficult to make that assessment based on the missing pieces of the puzzle at the moment, right, in terms of the test, the thresholds, etc.. So, you know, it's hard for me to say that one particular bright line threshold is appropriate at this particular juncture. Um, you know, I think that as noted, there should be a thorough investigation process, you know, which is which is fair to all parties concerned, you know, and efficient as well, but I think beyond principles at this stage, I'm not sure I can really answer that question with certainty.

Phil Azzie: [00:23:04] I'm afraid I'm going to have to intervene here, we are at 15 minute limit just added, so okay.

Koebernick: [00:23:11] I can pass it, quick question though. Working groups. You talked about a working group that we had before when we developed guidelines. And you found that an effective mechanism for participation. We really want to understand and we want to help, uh, stakeholders participate in what we're doing, and that to you, was efficient and effective in developing guidelines that everyone could live with in the past. From what you're telling me.

Declan Hamill: [00:23:41] Yes, particularly I think back to the dip methodology discussion, very technical discussions that did happen over a number of years. However, it enabled patentees and board staff and others to get in the room and really hammer out a deal that made sense in a way that that really responded to the board's mandate, but also, you know, provided some bright line, predictable kind of approaches for companies. So we found that to be  a very appropriate process.

Phil Azzie: [00:24:15] Well, I'll, I'll call on our second presenter, Kerry McElroy, country head, market Access and Public Affairs, Sanofi Canada. Floor is yours.

Carrie McElroy: [00:24:29] Thank you, Mr. Digby and to the board that's here and those online, thank you for inviting us to join you today. Thank you. My name is Carrie McElroy, and I am the country head of market access and Public affairs at Sanofi Canada and we're appreciative of the opportunity to appear here today. 
 Sanofi is a research based global health care company, our purpose is to pursue scientific and medical miracles to improve. We have one of the broadest and deepest product pipelines in the industry, spanning medicines and vaccines across multiple indications and treatment areas, with a focus on unmet patient needs. We also have a long history and current portfolio in specialty medicines, including for rare diseases and in oncology. 
 Sanofi is a unique leader in the Canadian life sciences sector, and we would like to bring that perspective to today's sessions. We are a prominent manufacturer for Canada's domestic biopharmaceuticals market, and from a capital perspective, we remain on track to deliver over 2 billion dollars in new investments to Canada for the period of 2018 and 2020, focused on our industrial footprint, our supply chain resilience and health system sustainability. Pandemic preparedness is a key focus of our ongoing planning and our new investments. Sanofi is proud to be the largest corporate life sciences investor in research and development, and among the top 25 corporate R&D contributors to Canada overall. We are strongly committed to Canada, as we have been for the last 100 years. Sanofi, with respect to the guidelines renewal process and the current scoping document, we wish to offer a number of considerations based on our track record of pricing, compliance, and our urgent desire to ensure that Canada remains a leading destination for new product launches and future investments. 
 Today is likely premature to delve into granular technical questions of administration, but we would welcome the opportunity to work with the board on providing feedback for any specific proposals in this regard in the coming months. The burden of PMPRB compliance falls exclusively on patentees as a principal stakeholder and guidelines process. We look forward to participating in guidelines development and not simply reacting to late stage proposals. Sanofi strongly supports the positions and submissions to be made by our trade associations Innovative Medicines Canada, Biotech Canada and RAREi Building on their submissions, I would like to focus my remarks around three points this morning. First, that the next iteration of PMPRB guidelines must focus on the board’s clearly delineated legislative mandate. Second, providing the necessary transparency, predictability, and operational stability to facilitate patentee compliance must be emphasized as a fundamental aspiration and policy objective of our future guidelines. 
 And third, that there are strong public policy arguments to manage vaccines in a differentiated way, with the future guidelines fully consistent with the PMPRB’s established mandate, reflecting the PMPRB's mandate. It is a fundamental reality that the PMPRB's statutory mandate is grounded in the Patent Act, with a focus on non excessive pricing. I will note now, as I expect others will during these sessions, that this mandate has unambiguously been reinforced by recent court decisions. Canada's pricing and reimbursement landscape for innovative medicine is complicated. There are multiple established agencies with separately defined mandates, stakeholders, and levels of government involved. PMPRB is different in both legal and practical terms, and PMPRB's role as a quasi judicial agency focused on non excessive public or list pricing is very clearly established as apart from those other processes and bodies.
 We would recommend that going forward in the guidelines development process, this mandate be stated clearly at the outset. This has the advantage of focusing efforts within the board's purview while avoiding unwarranted or extraneous attempts to address concepts more popularly or properly under the scope of other existing agencies and processes. One of our key reflections on the experience of the last number of years has been the destabilizing nature, caused by a lack of clarity on future compliance, expectations and requirements. 
 I will reiterate the point which has been made repeatedly. Canada benefits from innovations developed here as well as at the global level. Launch decisions will depend on multiple factors, but compliance predictability is a key component. 
 Predictable operational stability benefits all parties. Most importantly, it allows all Canadians and our health care system to be early beneficiaries of new medical innovations. It allows Canada to compete and win future R&D investments, which often depend on access of standard of care treatments. And it allows board staff to apply resources to the more complex matters within its mandate. 
 Pharmaceutical supply is also an important consideration for Canadians and our health care system. Canada's supply network is under significant pressures due to inflation, as well as many ongoing new cost containment measures at the purchasing or reimbursement level. The importance of recognizing changing prices in a wider economy, as measured by the Consumer Price Index, should not be overlooked or omitted as a core operational policy consideration for the PMPRB.

And that's consistent with the [00:30:01] Patent Act. [00:30:02] Any future guidelines should also offer clear and predictable rules governing price adjustments aligned with the Consumer Price Index. The Government of Canada and all levels of government around the country have rightly made regulatory agility and efficiency areas of public policy focus. I would strongly recommend and encourage the PMPRB to take a similarly modernized, predictable and forward looking approach to the guidelines. 
 Vaccines are an important and major part of Sanofi's global and Canadian, and fundamental to our history and major investments in Canada. These remarkable innovations are a critical tool in managing known and emerging infectious diseases, literally impacting the lives of millions of Canadians and our fellow citizens around the world. They require not just the latest cutting edge developments and therapeutics, but also the most complex and sophisticated industrial and supply chain capacity of almost any industry. Canada's system for the pricing and reimbursement of vaccines is sophisticated and has evolved over decades. It has a number of established elements which differentiate vaccines from other therapeutics and inputs into our health system. Beyond the often separate and extensive public health administrative and delivery pathways. Vaccines are subject to separate expert reviews for clinical value and implementation considerations. This work principally occurs via the National Advisory Committee on Immunization, NACI. Unlike most other new medicines, vaccines are then typically procured centrally by Public Services and Procurement Canada on behalf of the provinces and territories, using a range of structured tools, including formal tendering mechanisms. We've also seen the more recent use of separate advance purchase agreements in the vaccine space. The net result of these structures and practices is a vaccines market, which is qualitatively and structurally different than that of our other medicines, These differences also translate to a different context for pricing risk, and particularly the PMPRB's interest in non-exclusive pricing. Accordingly, we would strongly recommend that the PMPRB take an appropriately announced, nuanced and clear upfront approach to patented vaccines, reflecting these realities and attendant low risk of non-exclusive pricing. The obligations and overall regulatory burden on patentees with vaccines subject to PMPRB jurisdiction should be adjusted to reflect known structures, activities and risks to non-exclusive pricing. I'll leave you with a few words to conclude my remarks. We view today as the start of a much longer process of revising and issuing the new PMPRB guidelines. We look forward to learning more. More details about how the board would propose to implement the recently adopted regulatory changes consistent with its established mandate. I would reiterate my earlier comments around striving for clarity, predictability, and administrative efficiency in the new guidelines. Compliance should be a shared goal, with investigations and hearings as an exception rather than a preferred approach to enforcing the guidelines. There's also an available and well justified approach for the PMPRB to treat patent vaccines in a much more risk adjusted manner. I'm optimistic there's a way to draft and implement guidelines to ensure communities are protected from excessive pricing, that companies know the requirements and can plan accordingly, and that the board itself fulfills its clear mandate. We look forward to participating in any next steps, including potential technical discussions on some of the key granular details. And ultimately, we're all working to ensure Canada remains a globally competitive market for new medicines. Canadians want and deserve to benefit from sustainable and timely access to new treatments available today and those that scientific enterprise has yet to uncover. Thank you.

Phil Azzie: [00:33:58] Thank you very much again. I'll turn it over to the board.

Peter Morland Giraldo: [00:34:01] Thank you. I do have a couple of questions. Let's talk about vaccines, and I think we understand that. But there are centrally procured vaccines, and there's a lot of vaccines on the Canadian market which are private paid, that they're optional and they're not centrally procured, I can see how centrally procured ones might be at less risk of excessive pricing, but could the other vaccines up to individuals to pay for those?

Carrie McElroy: [00:34:44] Still go through processes that exist in the system, right? Whether depending on who the payer is or what system is going, but whether it's public health or it's evaluated by [00:34:54] CADTH or Inci, [00:34:56] and then it will go to the jurisdiction. So there's still sort of stop gaps and measures along the way to protect.

Koebernick: [00:35:07] Because I'm learning a lot. An innovation for me is, you know, only an innovation when it gets to the patients. Until till then, it's just a discovery somewhere. So, I'm sure that when you're making a decision internally about setting the price of a medicine, you're taking into consideration the fact that you want to bring this medicine to the patient as quickly as possible. Can you tell me what are the factors that you are taking into account? I know there are some other companies in the room, and you don't want to, um, tell any secrets, but generally, what are the factors that are important when you are setting a price?

Carrie McElroy: [00:35:54] Yeah. I mean, certainly the regulatory environment in any country is important and the processes, the time to listing to bring a product to market. When you're a patented product, you, you know, you have a limited time to do so. Um, the framework of which it's evaluated, there's many concerns around kind of  the overall ecosystem, as you said earlier, that you have to evaluate on each country and they're very different. So when you're a global organization, you're evaluating each country with many of those aspects.

Marie Perrot Thomas: [00:36:28] A quick question? So you made a comment which I found intriguing that, um, well, many comments are intriguing, but investigations and hearings should be exceptional. So I think a hearings are exceptional. We haven't had many over the past ten years, certainly since I've been sitting on the board. I've been on whatever there was. So three maybe so not a lot. But investigations which I think is interesting because the purpose I would have thought of the investigation is to not get to a hearing ultimately if we could.  And do you find that there's been a heavy burden with investigations? Would you feel investigations shouldn't take place or should only take place at a certain trigger? I'm curious if you have some views about the investigation process.

Carrie McElroy: [00:37:19] I mean, historically we've not really been involved. And as you say, there haven't been many, right? This is an opportunity to create something different. So I think we want to ensure that we're not being managed in a different way around investigations, that they're used appropriately. And I'm certainly not probably the best expert to say that. And I think an expert technical committee could probably land on something there. Um, but we just want to, to address that. So that's not where we end up for sure.

Marie Perrot Thomas: [00:37:43] And you're talking about investigations with respect to vaccines in particular or?

Carrie McElroy: [00:37:48] No, just  in general.

Phil Azzie: [00:37:55] Thank you very much.  I'll now call on the next presenter. Andrew Casey, president and CEO of Biotech Canada. Floor is yours.

Andrew Casey: [00:38:12] Well. Good morning. Thank you very much, it's good to see you. Appreciate the time.  I am Andrew Casey, president CEO of Biotech Canada.  I think it's probably important to get a couple of things clear right off the bat,  I am not an expert on pricing, this is not my expertise. We have all sorts of technical experts in the audience. You're going to hear from them as well as others. I certainly would echo the comments of my colleagues from IMC and from Sanofi in terms of some of the technical feedback. 
 I'm here because this is kind of our only opportunity as biotech candidates to sort of influence and shape the guidelines. Once the guidelines are in place, then the remit to the team PMPRB is less likely to be sort of listening to what I'm going to talk about today, which is investment partnership, the ecosystem that exists in campus. And that's where I want to focus my remarks. And so I'll do first introduce Biotech Canada, because we are representative of the biotech ecosystem in this country. We have about 240 member companies across the country, they are in a number of different disciplines. We have industrial, agricultural, environmental, biotech companies in the membership, but that's a small percentage, put them aside for obvious reasons. We have in the life sciences health space pretty much all of the multinational pharmaceutical companies that are doing business in Canada. But again, they represent a fairly small percentage of our overall membership. 
 The bulk of our members are early stage companies that have an innovation and idea molecule that has come out of one of our universities or research centers, and they're trying to commercialize it. They're at different stages. They can be 1 or 2 people with that idea just come out of the university just setting up an organization, or they can be much further down closer to commercialization, it could be 300-400 people. So you might have heard of recently of Celera would be a perfect example of that, which is one of our members, and then everything in between. And what they're trying to do is find investors and find partners. Investors come in all sorts of different shapes and sizes, you have venture capital, you have investment bankers. But one of the big investors and partners in the industry are the large multinational companies that sort of participate in the ecosystem. And so they are an incredibly important part of what sort of shapes the Canadian biotech ecosystem and the ability of companies to get their products to a place where they're ultimately going into people. They're just good ideas at this point in time but to get into it, I started this job 12 years ago and at that time, one of my members said, go and sit down and meet Michelle Boudreau. She was the CED at the time of the PMPRB And I said, okay, I had lunch with Michelle. We had a nice conversation; We didn't have a lot of intersects. She was preoccupied with a bunch of things that were not even anywhere remotely near what Biotech Canada was so worried about. And then Doug came in and met again with him very quickly, he came to my board, probably around 2015, talked to them, talked about where he was seeing the organization going in at that time, talking about changing the basket of countries, we had a good discussion, but it really wasn't all that directly important to us. And then the big changes came, and that's when a lot of my members said, well, that's going to change the way we do business in Canada. So we're going to, in a way, change our investment structures. And that's when it became more important to Biotech Canada, the Biotech Canada membership. And so we became very implicated in the initial phases of PMPRB work, and then the pandemic hit, and now we're into a different phase where you have governments around the world, the Canadian government saying we don't want to go through that experience again of building an airplane while trying to fly it, and we're trying to change the environment and we're going to prepare for Covid 50, Covid 60, you pick your year, we don't even know if it's going to be a coronavirus, what is it going to be if you don't know what the challenge is going to be, you don't know what the solution is going to be. So what the pros approach is being taken right now by the Canadian government. And we're not alone in this, but it is to sort of create as many opportunities as possible so that when you get to that next challenge, you're ready for it. That's example I can use, if you look at the one of the vaccines during the pandemic was the quote unquote, Pfizer vaccine. Pfizer vaccine was actually a partnership between Pfizer BioNTech of Germany and Equitas out of Vancouver. That's the new model of drug discovery and development. It's that partnership, and that's what we have to prepare for. So you have the biomanufacturing life sciences strategy that's been underway right now, which my colleagues referenced earlier. Even the National strategy for Rare disease is part of this. But we're in a world where we're trying to prepare for that, and the challenge we've got is it's a very competitive world. Every other country in the world is doing exactly the same thing, and what we've got in biotech ecosystem are essentially good ideas, and if we're not able to attract investment and partnerships in Canada, those good ideas are going to go to where the investors and partners are. I came here from the forest products industry, they go through the same sort of process, they've got to find investors to upgrade their mills, their processes and everything. If they aren't able to do so, they can't pack the forest up and leave. Where the investors are in this industry, what we're talking about are essentially good ideas. They reside on computers you can do clinical trials from anywhere in the world. So if you're not able to attract the investors here and the partners here, those good ideas will go elsewhere. We'll eventually maybe get them back at some point in time, but we'll missed out on all the benefits of commercializing here while we're doing it. So that is my preoccupation as an organization. And that's why I say this is a conversation I cannot have with the executive director once the guidelines are in place, because, and understandably so, it's not part of his or her agreement at that time. So I have to this is my one opportunity to get to make this case. The world has changed and we have to figure out a new way to do it, so when you think about certainty in that environment that was referenced before, that's what we're trying to sort of create here, an environment that the company say, I want to do business here, I want to be part of that ecosystem. And my apologies to colleagues who heard me speak yesterday, but the ecosystem is like a coral reef, and a coral reef has many constituents, you have pretty fish and ugly fish and big fish and small fish, you have plankton and algae, sand, light, dark, all it has to everything has to be sort of in concert. And if one of those constituents is not healthy the overall health of the coral reef suffers. And that's how we have to look at this ecosystem, so this is one of my opportunity to say, when I think about the PMPRB, the influence that can have on the company's decision to do clinical trials, to do research here, to do investing here, this is where we have a huge concern if we're not providing that certainty and clarity that was referenced earlier and staying within the mandate of protecting against excessive prices. I will stop there. The risk of actually having to take questions, but I will try and take questions. I really appreciate the time.

Peter Morland Giraldo: [00:44:52] Very colourful description of the life sciences ecosystem here in Canada. And thank you for that, so, so much in there I would like to start with, you know, my experience in Big Pharma was that the decisions made about whether where to invest research money was quite separate, actually from the operational team that might be setting up a manufacturing plant, or there's certainly the sales team which is trying to, you know, generate revenues in a particular company, that these are quite separate divisions generally, one is run from the head office and the other are local, so do you find that there is a connection between what the research investment decisions of a big company might be and the actual price for an unrelated set of  valuable products that are in the market, you find there is a link between the view of that.

Andrew Casey: [00:45:53] So I will agree with part of your assessment that some of those decisions are made, and it doesn't matter what what's going on. So if you think of some of the deals that were signed between a large multinational company and a biotech company, let's take [00:46:07] [INAUDIBLE]  [00:46:07]most recent example out of Montreal, $1.4 billion deal, which, yes, that was going to happen no matter whether or not GSK had a single product in this country that was that deal was going to happen. I would agree with that because [00:46:18] they [00:46:19] had good science they had a product that fit the pipeline. So those are going to happen no matter what. When you get into manufacturing decisions, where to set up manufacturing, that's going to be a bit different. And so you have Sanofi is a good example. They've just added facilities in Toronto that the GM at Sanofi Canada goes to a global table and has to make the case on why it's a best fit here, but that definitely does have an influence. And the factors that influence those decisions, where you've got your colleagues from Brazil or Europe or whatever, saying, why would we invest in Canada? They don't even buy our products. It's an uncertain marketplace, that's where it does have an impact. I would also say it impacts their decisions on where to put clinical trials, which I consider to be a really important part of the research. That's where a lot of ideas come out of, it's also where we develop an expertise. And as we're seeing  the Canadian companies grow, those clinical trials become increasingly important for them. So if we lose our expertise in the clinical trial area, I think we lose our competitive edge from an ability to not only bring new medicines to Canada for Canadians and the value that brings to the health care system. But I think it also impacts our early stage companies and their ability to take that product and move it out to the commercial markets.

Marie Perrot Thomas: [00:47:28] And how the guidelines would be for what you're describing, a factor positive for your company?

Andrew Casey: [00:47:38] I think you can create certainty, just as was talked a bit about earlier, the closer we get to certainty where you have a predictable environment that's also based on the mandate of.

Koebernick: [00:47:48] Can you be a bit more specific, what do you mean by that?

Andrew Casey: [00:47:51] Well, no, I can't I technically I don't know how you do it, I really don't, but I do know that the uncertainty that's being created, particularly when it goes beyond accepted pricing that does create nervousness [00:48:04] [inaudible]. [00:48:04] How you get there will have all sorts of technical advice, and we're going to put our submission written submission in to you as well, and that will have all that, because there's too much waterfront to try and figure that part out, but it was I think back to when the Minister of Health stood up and announced these changes, she cited Mylan [inaudible] and Valiant at the time as being problematic. I would note that none of those products were a problem in Canada, and that's because we had in place CADTH and pCPA, and so we've developed something that's quite comprehensive for, I'm not so sure, a problem that really exists. And so if we can get back to what the true mandate is, which is the excessive pricing piece that came out of the 1987 change, that's probably a better place to go. How we get there, we'll submit written questions, that’s for sure.

Marie Perrot Thomas: [00:49:00] Thank you.

Peter Morland Giraldo: [00:49:04] One quick question. So,  expedited price reviews. This is a technical question that's going to come up probably later today or tomorrow. If people could move faster to getting a pricing approval in Canada without uncertainties caused by our board, would that fill part of your request or your thoughts?

Andrew Casey: [00:49:29] You’re referring to CADTH and Health Canada?

Peter Morland Giraldo: [00:49:32] Well, no, I think our board, in coming to a quick decision by the PMPRB.

Andrew Casey: [00:49:38] That's assuming in terms of a problem area, you're not talking about just generally?

Peter Morland Giraldo: [00:49:45] Well, uh, I'm talking about doing a faster review in sort of like a 90 day time period. You get the initial pricing from rights holder. And then we do a quick review of that and say if it if it comes in at our standards, then we could give that a quick review with that.

Andrew Casey: [00:50:02] My colleagues Declan or.

Declan: [00:50:05] Well, yeah. I think the way you phrased it is interesting. Sorry to abruptly take the floor again, but, uh, yeah, I mean, I think, you know, overall, you know, really the concerns that we have around access and availability are not so much with the time that the PMPRB is taking in its in its processes. It's more what happens after that. Right? It's the pCPA negotiation process. It's the HTA processes which influence that. It's the public payer decisions, etc.. So, you know, from an accelerated access perspective, you know, we're actually much more concerned with other parts of the chain, which is not to say that you know, the time that PMPRB takes is irrelevant. But as we said in our remarks, really the best thing PMPRB can do to help in that context is have a clear regime that people understand. So I'm not sure if timing is so much the issue as the regime functioning in an efficient way. And then, of course, there are problems which arise later, but those are respectfully beyond the mandate of the board.

Peter Morland Giraldo: [00:51:10] Thank you.

Phil Azzie: [00:51:12] Thank you very much. Now I see that our next presenter scheduled presenter is not in the room but is online and I just want to confirm that he is presenting, Joel Lexchin of Emeritus, University of Toronto, Canadian Health Coalition, Professor Lexchin, are you there and are you ready to present?

Professor Lexchin: [00:51:57] Hello. Can you hear me?

Phil Azzie: [00:52:00] Yes. Thank you, Professor Lexchin. The floor is yours.

Professor Lexchin: [00:52:04] Thank you very much. So my name is Joel Lexchin, I come at this from a number of different angles, I taught health policy at York University for 15 years, I was an emergency physician for 40 years, I authored guidelines for both general practitioners and emergency physicians about medicines to use to treat common conditions. And I am the author or co-author of over 275 different publications in peer reviewed journals on different aspects of pharmaceutical policy. 
 So the background for my presentation is that, in fact, the current operations of the PMPRB are not achieving their mandate of keeping drugs at a non excessive price level. And we can see that because of surveys that show that up to a fifth of Canadians report cost related nonadherence in other words, that they're not taking medications as prescribed because of the cost of them. They're splitting pills, they're skipping doses, and that's also seen because Canadian drug prices are the third or fourth highest amongst the OECD countries. And also the per capita spending in Canada is the third or fourth highest among OECD prices. So with that background, let me go to discussing the various themes That were laid out by the board in its most recent publication. 
 So first of all, on theme number one, the board should continue to categorise medicines by the level of therapeutic improvement. Between 60 and 70% of the new drugs that are introduced into Canada or any other of  the high income countries do not offer any more than minor or therapeutic benefits. Only about 30 to 40% offer moderate or major therapeutic advances. In addition to that, the board should consider redoing the definition of breakthrough, which needs to be done, since the term effectively is too vague. In other words, effectively treating a condition, effective treatment varies depending on the condition that's being treated and could mean life extending, significant symptomatic relief, significant preventive potential, or other definitions. So when the board is categorizing breakthrough products, it needs to do so on a drug by drug basis, determined by a panel of clinicians and patients who are all independent of any conflict of interest with the industry. International price comparisons cannot account for secret rebates that countries receive, and therefore the PMPRB needs to take that into consideration when it's deciding where Canada fits into the international mix. There's no guarantee that the secret rebates that are given in other countries are the same as the ones that are given here. 
 The median international price should be used as the initial triage measure, Otherwise, Canadian prices could be at the highest level in the PMPRB 11, and that's something we already see in terms of the current PMPRB or the previous PMPRB seven, where Canadian prices were the third highest on average. 
 Finally, in this theme, the premise behind question 1.6, is that most new drugs offer no more than minor to no additional therapeutic benefits compared to existing products. And this premise, as I've already stated, is faulty. Only about one third at most offer moderate or greater therapeutic benefits, and that's not my evaluation, that's an evaluation that comes from looking at the decisions made by the PMPRB's Human Drug Advisory Panel, the French Drug Bulletin, Prescrire International, and the German agency IQWiG. 
 Theme number three, which is price reviews during product life cycle. If the prices are to be reviewed after a period of time, it should be with the understanding that they could either be increased or decreased. The timing of price reviews should be based on the remaining period of patent protection, with drugs with longer patent protection being reviewed sooner. However, whatever the type of drug, prices should only be reviewed if there is new evidence about efficacy for the approved condition or new conditions. New evidence around safety or if new comparators are introduced, otherwise, it doesn't seem to me that there's a basis for reviewing prices. 
 Finally, if international prices are decreasing, then any allowable increase based on the consumer price index should be overridden based on the principle that if prices are going down internationally, they should also be lowered in Canada. 
 In terms of theme number five, primary purpose of any coordination of decisions should be to reach a decision about drugs with a significant therapeutic improvement, so that they are available to patients more rapidly, there is no need for drugs with lesser therapeutic benefits to be marketed more rapidly, they don't benefit patients. 
 Finally, with respect to theme number six, if the board is not basing its decision on evidence from randomized controlled trials, and I recognize that these randomized controlled trials may not be available for various reasons, then prices should be reviewed when higher quality evidence becomes available. Thank you very much for the opportunity to present.

Phil Azzie: [00:59:16] Thank you very much, Professor Lexchin. I'll now turn it over to board members who might have some questions for you.

Peter Morland Giraldo: [00:59:23] Thank you, Professor Lexchin, at the board here we've read a lot of your work and we're very familiar with your submissions in the past. 
 You are encouraging us to do price reviews during the life cycle of a product, we may set a price initially or a review a price and find it non excessive initially, but that we should maybe go back to reviewing it when the evidence changes or when new evidence is provided, new evidence of efficacy. Now, you did say  that at that point, prices might be actually increased if the efficacy is proven out and shown very beneficial, or it might be decreased if the efficacy never really materializes if it was a promise that never paid out. Would you be okay in that circumstance, giving the rights holders  the opportunity to increase their price as well as to decrease their price?

Professor Lexchin: [01:00:28] If  there's new evidence that shows that drugs are safer than they were initially felt to be, or if  the evidence shows based on good quality randomized controlled trials, that they're more effective than they were initially felt to be, then. Yes. I think that the companies should be able to ask for higher prices, but by and large a lot of drugs currently, especially ones that come in with a notice of compliance with conditions, are being approved based on surrogate outcomes, are being are based on phase two trials, these trials usually overpredict the effectiveness of new products. So when RCTs are done, if they're done, they typically show that the drugs are not as effective as they were initially felt to be. And in that case, the prices should go down.

Peter Morland Giraldo: [01:01:35] So this is the question of real world evidence and how the product actually plays out in the context of the Canadian health care system.

Professor Lexchin: [01:01:47] This isn't real world evidence. Real world evidence is typically felt to be observational evidence, which, while valuable, is not as good as RCTs. Observational evidence, by and large, not all the time over predicts efficacy and over predicts the safety of a product.

Peter Morland Giraldo: [01:02:11] Thank you. You also mentioned the balance between our rights holders are asking us to be able to take the consumer price, the inflationary increases that to which they're eligible under our act, but you're noting that the MIP of these products is often declining at an international level, there seems to be a tension those one is driving the price, might drive the price up, the other might bring the price down. And do you feel it's appropriate for this board to take both of those into consideration when we're reviewing a price?

Professor Lexchin: [01:02:54] I do, I mean, the board's mandate is that prices shouldn't be excessive. So it depends how you're going to define excessive, if you're defining them in terms of what the international prices are, then if those prices are going down and Canadian prices are staying stable or going up, then Canadian prices are going to become excessive relative to the international prices.

Koebernick: [01:03:25] I have a question regarding. Hello, doctor, sorry and  thank you for your presentation. And regarding personalized medicine, because with genomics research and genetics research, we are getting more and more personalized medicine on the market and actually more medicines treating rare diseases that are sometimes based on genetic condition. Do you think we should be looking at the prices of those medicines differently? And if so, how should we be looking at them?

Professor Lexchin: [01:03:55] So first of all, I've done some recent work which shows that medicines that when you classify drugs in terms of whether or not they're for rare diseases or for common diseases, that the rare disease medications do not show any difference in terms of the distribution of therapeutic benefit compared to not medicines for non rare diseases. In other words, the same percentage of drugs for rare diseases are of little to no therapeutic improvement, moderate therapeutic improvement or major therapeutic improvement. And secondly, with respect to drugs for rare diseases, these drugs often come out of  publicly funded research which means that the taxpayers have put money into the research for these products, and therefore the benefits are bringing these drugs for the benefits that these drugs derive should not in terms of financial costs, should not all go to the drug companies. When setting prices, you need to take into consideration the fact that public investment has been into has been made into the development of these products.

Phil Azzie: [01:05:33] Thank you. Thank you very much, Professor Lexchin. So that concludes the first part of the morning session. I would like to thank all five presenters. Believe it or not, we are right on schedule. So we will reconvene at 10:30, 30 minute break. But we will begin at 10:30 sharp. Thank you very much. 
 Welcome back, everyone, to the second part of the morning session we have six presentations scheduled for this period of time and our first presenter is already seated, so Jonathan Soong, General Manager, Amicus Therapeutics Canada Inc Canadian Forum for Rare Disease Innovators floor is yours. Thank you.

Jonathan Son: [01:06:16] Good morning. Thank you for the opportunity to contribute to the consultation relating to the development of new guidance for Rightsholders regarding compliance with the board's price review process. As mentioned, my name is Jonathan Son, I'm the general manager for Amicus Therapeutics here in Canada, a little bit of background. Amicus is actually a global organization, we're a small but impactful developer of important treatments for rare disease patients. Today, I'm here representing the Canadian Forum for Rare Disease Innovators, more commonly known as RAREi. The group has allowed 17 innovative companies to work together to address policy issues of specific interests to the rare disease community, and I'm honored to provide the perspectives of a rare disease developer building on our engagement on this issue during the past several years. Where I would like to acknowledge the approach the board is now moving towards the creation of new guidelines. This two phase effort offers stakeholders the opportunity to first set up goalposts around the PMPRB’s core mandate, anchored within the broader goals of Canadians, including those diseases. And second, to delve into the specifics of how price reviews would be conducted, building on these guiding principles, where I hopes to continue to be part of the discussion as both these goals are met. 
 To start, allow me to share RAREi perspective on an interpretation of the board's mandate, as has been established in several recent court decisions and mentioned by several others prior to me, it is our view that the board's regulatory remit is to act as a watchdog against patents abusing the market exclusively benefits that their patents bestow upon them. In short, the board is intended to protect Canadians against excessive pricing of patented products while they remain under patent protection. With that in mind, I'd like to frame this mandate in the context of the government's broader life sciences, innovation and rare disease policies. Since the Covid 19 pandemic, the federal government has made it clear that it wants to nurture and support a vibrant and sustainable life sciences and biomanufacturing sector in Canada. And to signal its intention in a variety of ways, including establishment of a multi-year bio manufacturing and life sciences strategy, a genomic strategy, a pediatric medication development initiative, a variety of regulatory modernization initiatives related to health product review and an approval of the National Rare Disease Drug Strategy. These new strategies have been accompanied by multi-year funding commitments, demonstrating the government's commitment to their success. These developments, along with the PMPRB seeking feedback today from industry members and other stakeholders, gives me encouragement that innovation, new product development and the use of new medicines can be greatly improved and shifted. Considering those clear statements of policy intent by the government, the PMPRB can play a role in helping the government succeed by ensuring that it operates in a manner that is consistent with those stated policy goals. Given the focused mandate and the policy goal to promote and encourage innovation, RAREi takes the view that the board must undertake its oversight responsibility with care to avoid dissuading innovators from undertaking research, development and commercialization of important treatments for Canadians and the world. Before diving into our recommendations, I'd like to take a moment to discuss some of the challenges faced in the rare disease environment. It's a difficult area to operate in, due in large part to the high degree of uncertainty and variability at a national, provincial and even regional level. There's variation in prevalence and incidence rates for genetic conditions, different mutations can affect how conditions present, how conditions present, the speed of progression of disease, and even severity of disease. Who treats these patients, how conditions are managed and even who's eligible for treatment can also change from area to area. At the end of the day, there are few, if any, large data sets to draw from, and many clinicians struggle to identify, much less manage, these conditions. Given this, to develop and ultimately commercialize a product for a condition with so much uncertainty present is a daunting task. Fortunately for patients, efforts to smooth the path and rare disease product development and accessibility in many countries have resulted in companies like my own developing and commercializing an impressive range of therapies for patients, these efforts represent a good model for Canada to consider, as thus far it has offered few measures that its main comparator countries that provide. 
 As the general manager of a Canadian affiliate, part of the role is to make the case for new medicines to be brought to Canada, it is a responsibility that the general managers all take seriously, with the shared goal of getting much needed medicines into Canada as quickly as possible and into patients as well as was highlighted earlier. To be clear, the upfront cost of doing business in Canada can be high, submissions to Health Canada and Health Canada's health technology assessment agencies are part of this, as well as the ongoing cost of doing business here which also play a factor. Operating costs are higher here than in many comparable markets because of the need to comply with a range of regulatory, medical, reimbursement, related and commercial activities necessary to support the successful deployment of new medicines in Canada. Ultimately, the cost of even bringing one new medicine or new indication to Canada can sometimes range into millions of dollars. Uncertainty when it comes to price is one of our major challenges. Beyond the direct implications on a Canadian business, pricing in Canada does not operate in a vacuum. 
 Canada, which represents often about 2% of the world market, is often used as a benchmark for other large markets, meaning that our prices can have a follow on impact on these markets. This, in turn, can influence decisions on when or even if to bring a product to Canada. To state it plainly, the market uncertainty that has characterized the PMPRB’s price review modernization process has been damaging to Canada's attractiveness as a location for global investments. It has resulted in a downward trend in new product launches and much difficult conversations within companies before they decide whether it makes commercial sense to bring a medicine here with that context in mind, where I recommend that the board be pragmatic in its approach to price review and vitally provide rightsholders with the certainty required to run a business that is fraught with uncertainty. The effect of price ceilings permitted by the PMPRB were already a challenge for some rare disease innovators before the challenges, before the changes to regulations that have led to this consultation. Any go-forward imposition of the lowest benchmarks will continue to send challenging signals to deploying medicines in Canada. We'll continue to send challenging signals that deploying medicines in Canada may be subject to onerous and uncertain price controls. 
Since 1987, when the PMPRB was established a multitude of effective price lowering and value enhancing initiatives have also come into play. There are numerous other entities within the Canadian health care system at the national, provincial, and even private payer level, which aim to assess and value innovation and to ensure Canadians have access to innovative medicines in a cost effective manner. The PMPRB's role in this context should be grounded solely in its legislative and constitutional mandate, specifically to prevent the abuse of market exclusivity, not the legitimate use of market exclusivity. 
 Intellectual property is the most important driver of innovation, allowing developers to create and deploy new medicines that help save and improve lives, it is time limited, and during that period, the PMPRB should confine its role to being that backstop that protects Canadians against excessive pricing of patented products and not engage in price controls or attempts to lower prices, and where there is no evidence of abuse. As mentioned, ongoing uncertainty related to pricing can impose challenges that have a similar impact as too-low price ceilings. If companies are unable to rest assured that an approved pricing level remain compliant, it makes it even more challenging to build the case for entry into the Canadian market. 
 A pragmatic approach to national price review is particularly important for rare disease innovators, which, as I previously mentioned, operate in a challenging and competitive global market. Predictability at every step, including at the PMPRB, would increase Canada's attractiveness for new medicines that many Canadians with rare diseases badly need. My colleagues and I at RAREi are hopeful, are hopeful that this current dialogue will lead to a pragmatic and predictable price review process that will encourage the innovative spirit represented by companies like Amicus, and ultimately align with the Canadian government's policy interest in supporting innovation and life sciences expansion and access to rare disease medicines. In summary, RAREi recommends the following comments for the board's consideration, the board should consider obvious excessiveness as the only standard for pursuing a price review, given that the courts have made it clear that the PMPRB's mandate is limited to protecting against abuse of market exclusivity. The following should be considered. A list price that is equivalent to or lower than what is being charged in other PMPRB 11 countries should be deemed compliant, provided that price increases are limited to the board's existing CPI adjustment factor, then it should be deemed to have remained compliant and therefore not subject to further price review. In some cases where there is a clear unmet need, or in therapeutic areas where there is a public policy rationale to support it, higher prices than what is available could be warranted as a means of encouraging commercialisation of new rare disease medicines in Canada.
 If a product is primarily used by public payers and hospitals, or a blood product that is subject to tendering by relevant agencies, then the board should consider a lighter approach to additional price reviews, such as the ones it takes for vaccines. So, you know, as previously discussed, if there's kind of other measures in place that would prevent that excessive pricing. For instance, if the pCPA is successful in securing a high value commercial arrangement, is it really necessary that a deep review takes place? Finally, with regards to providing certainty to rights holders, RAREi recommends that all prices of existing patented medicines that were deemed to be in compliance prior to the new Patented medicines regulations were passed should be accepted as compliant, provided that the price is not increased beyond the board's existing CPI adjustment factor, and that the PMPRB should continue to rely on voluntary compliance undertakings to address any findings of Excessiveness.
 In conclusion, it is RAREi's position that the PMPRB should be focused on its core mandate and operate as a passive oversight agency that guards against an abuse of market exclusivity, which is a high bar, especially in the context of so many other price moderating and value generating initiatives in the Canadian public and private payer space. Thank you for your attention, and I'm happy to address any questions.

Peter Morland Giraldo: [01:17:04] Thank you Jonathan, interesting comments. And  I'm sure everyone has questions here because, I have to say you served up a couple of whoppers there. And you don't have to answer this, and I know some of your other rights holders in the room will probably comment on this. You said Canada is often used as a benchmark in international pricing, it's not it's,  it's used in China for their basket, it's used in Brazil, but it's not used anywhere in Europe as a as an international reference price to our knowledge. So we're just going to look at that question, maybe people can help us understand why our understanding is different there, and you've been using the word excessiveness, is the same as abuse of market exclusivity. Now, it's our understanding that in the Patent Act, there's several references to the word abuse of patents, but that doesn't come up in the PMPRB section, they've used a different word, not abuse of patents, but excessive prices, so now you're linking the two, you think that excessive does mean abusive, because we think  excessive may be something less than abusive pricing?

Jonathan Son: [01:18:33] So it's the board's perspective does that kind of excessive would be a layer below.

Peter Morland Giraldo: [01:18:38] Includes  more prices than an abusive price would be, do you have any comment on that?

Jonathan Son: [01:18:46] I Think that was the group's kind of interpretation of that, was that kind of excessive pricing of the patent holder and our position there.

Peter Morland Giraldo: [01:18:57] Thank you for that.

Koebernick: [01:19:00] Okay. A couple of just clarifications, so help me here. The major impediment are, I feel that you've cited, but first of all, you want certainty obviously, rightsholders want certainty. Too many reviews, so the reviews by the board, ongoing reviews, the chairman exclusivity is creating uncertainty for your organization, so once you're in, you feel that should be it leave us alone, and I don't mean to be disrespectful at all, I'm just trying to understand the process. So other than the CPI adjustment perhaps?

Jonathan Son: [01:19:41] I think if there was kind of clarity on what those are and even kind of coming in as well, as how it's going to be maintained, right? So there has to be, I guess, a level of certainty around what that price level will be. I think every benchmarking of prices could be a real challenge to kind of what the business cases that we often have to make are.

Koebernick: [01:20:02] Okay. And you talked about grandfathering to a sense I don't know if you use that firm, but maybe yeah.

Jonathan Son: [01:20:09] I think the grandfathering of kind of previously approved kind of assets.

Koebernick: [01:20:13] And can you just talk to me a little bit about that? Because somebody else here, I think mentioned it this morning, the whole issue is that there's nothing, nothing that really is in legislation or regulations that speaks to grandfathered bearing, so it would be helpful if there is something you want us to use somehow. Then what would that look like to you?

Jonathan Son: [01:20:34] I think it's just, you know, for the medicines that have been, you know, previously approved or their price levels have been approved prior to this, so that, that is kind of maintained because, you know, essentially, the entry into the market was based on those price levels and their ongoing kind of presence in the market is based on that. So kind of resetting that or applying kind of new rules to kind of what was previously set could potentially be a challenge.

Koebernick: [01:20:56] And it creates, I guess, more uncertainty again, for everybody else. It's something that people want, and we understand that they want or I think that's in our scoping paper, we're asking for people to comment. And we're also asking for advice I suppose on if that is what you want, how we would do that. So I just throw it back to people. I don't need answers now. But again, you know, we're struggling with things that we understand what you need and to some extent, and while we may be receptive in some areas, we're going how would we do that?
So if you have suggestions, please feed them into your submissions for sure.

Jonathan Son: [01:21:36] That's part of the written submission I'm sure would be great.

Koebernick: [01:21:39] Thank you very much.

Phil Azzie: [01:21:40] We are at the time limit so we're okay.

Jonathan Son: [01:21:43] Thank you.

Phil Azzie: [01:21:44] Thank you, thank you very much. I'll call our next presenter, David Stewart, medical oncologist at the Ottawa Hospital. The floor is yours and I understand there is a presentation as well.

David Stewart: [01:21:56] Yes. I'm going to be presenting some slides and I'll be cutting out a few in the middle just to leave enough time for questions. I'm a medical oncologist at the Ottawa Hospital and the chairman of the Life Saving Therapies Network, and it's really on behalf of Life Saving Therapies Network that I'm presenting today. So, my disclosures… about 98.5% of my income comes from patient care, 1.3% from pharmaceutical industry and 0.2% from others. So I recently published a book called A Short Primer on Why Cancer Still Sucks available on Amazon Books. I'm happy to send a free electronic copy to anybody who sends me an email, happy to do that. So cancer still sucks because first of all, it's very, very common and it's often very difficult to treat. And Canadian patients actually have very poor access to medical care compared to what they should have, and they've got poor access to effective new therapies. So if we just look at survival rates with cancer in the United States versus Canada that tells us that of the 84,600 patients who died of cancer in Canada in 2021, about 11,400 would have survived if they had this rapid access to diagnosis and treatment, as in the United States. And so what are we not doing? So if you look at the OECD we rank 30th out of 36 in number of [01:23:21] CAT scans per [01:23:21] million population, behind Turkey and Greece and Chile and all of Eastern Europe.
 We're now nearing the bottom in MRI scanners, Pet scanners, hospital beds, radiotherapy machines. And everybody talks about the shortage of family doctors, but our real problem is we've got two marked shortage of specialists in Canada. So what about access to effective new drugs to alleviate suffering and prolong high quality survival in patients with advanced cancer? So Health Canada does a reasonably good job at reviewing drugs. So overall Canada gains access through Health Canada about one year after first global launch of the drug. Our huge problem is in public funding because it takes another year and a half to get public funding where patients can actually get it through governments. And so that time to public funding again, a year and a half after the OECD median  where patients cannot get access to these drugs, that can help them. So one of my colleagues Johanna Gottfried recently published this paper where she looked at the number of life years lost between the time that a drug was demonstrated to be effective and public funding in Canada. And so these drugs do alleviate suffering and prolong life expectancy and thousands of Canadian life years are lost unnecessarily due to these delays, so this is just an example from just breast cancer and lung cancer recently, thousands of life years lost in the delay and access to public funding.
 So what does this have to do with PMPRB, We know that PMPRB recently decided to align with 11 countries and that, by my calculation, would reduce the average cost of drugs by about 20% in Canada. So this is a slide from the PMPRB presentation in 2020  where they said that countries with lower patented drug prices in Canada may have greater availability of new medicines. I just took the data from this slide, this  PMPRB data, and I reanalyzed it, and so on the left is non-European countries, and what a country is willing to pay for a drug has marked impact on the availability of that drug and similarly, in Europe, you pay less, you're going to have access to far fewer drugs. So just during the calculation, the  PMPRB forces down drug prices by about 20%. Canada with Canadians would go from having access to about 48% of all new drugs to about 35% of all new drugs, and also access would be further delayed. So not only would there be fewer, but take longer to get access,  and that's what the data tells us. So Canadians might have lived with high quality of life instead of suffering and dying as they cannot get access to these effective new drugs. So will the PMPRB at least level with Canadians about the impact of their changes on access of Canadians to these effective new drugs? So this is the rate of development of new drugs, it is going up very, very rapidly a lot, there's a huge amount of breakthroughs, a lot of new research that is leading to rapid access to new drugs. So I'll  leave out a couple of other cases that's going to present just to save time, but I'll just present one. I've changed the names in accordance with privacy regulations.
Susan was a 70 year old female who had smoked an occasional cigarette in her 30s, but not in the last 40 years, she was admitted to hospital in early 2021 with depression and delirium, a CT scan of her chest showed a large lung mass with several metastases, and MRI of her brain showed multiple metastases. A lung biopsy was positive for adenocarcinoma, she received radiotherapy and her brain and dexamethasone to decrease brain swelling, but continued to decline rapidly, she became barely conscious, unable to speak or get out of bed, and hardly able to swallow, and had a life expectancy of days to weeks, but her tumor had a rare mutation or an uncommon mutation called an EGFR exon 19 deletion. The new drug, Osimertinib, had become available and it's effective there, so we crushed it in applesauce and got it to a bit of it down her. And that was enough that within 24 hours, she  was awake within three days before she began to speak within two weeks she was walking with help. At three weeks she was transferred to rehabilitation. At five weeks she was discharged home, living independently, walking with a walker with a high quality of life. Now, in November 2023, her scans, almost three years after starting Osimertinib, showed a modest growth of her tumor, so blood tests tell us that there's a high probability that resistance to osteosarcoma is due to emergence of what's called a  MET amplification, MET inhibitors, If this is confirmed by biopsy, MET inhibitors would have a high probability of shrinking her cancer and controlling these resistant tumors. So MET inhibitors are approved by Health Canada and available to those with private insurance, such as those working with for the PMPRB and for most public federal government employees but not to patients with just public access, but she has no private insurance, and there's no publicly funded MET inhibitor in Canada, in many other countries, she would have access to a MET inhibitor, but not in Canada. 
 So I'll skip a couple of these and I'll just go to the last one. Judy, the 50 year old former smoker, in 2016, she  was diagnosed with adenocarcinoma of the lung metastatic to abdominal nodes, adrenal gland and brain. Her life expectancy without chemotherapy was 4 to 5 months. So she started chemotherapy and had surgery and CyberKnife for brain metastases. The chemotherapy in her worked much better than the average patient, and though she did well for two years and received 38 cycles of chemotherapy. But then in 2019, she developed a growing abdominal mass, which was very painful and becoming very large, but in September 2019, she was able to initiate the available drug immunotherapy drug [01:28:54] nivolumab, [01:28:54] which was publicly funded. She had marked resolution of pain, marked improvement, her CAT scan, and the last follow up of a couple of months ago she continued to do very well for years after initiation of this drug. And for example, you didn't show the other two of many patients who have done well and effective new therapies for incurable metastatic cancers. Progress continues to be very rapid. We can expect many new effective drugs in the near future. We must not jeopardize access to these therapies based on false economy, without these new these therapies, patients suffer much more and die much faster. There's an increase in emergency room visits and hospitalizations. There's a high cost of cheaper but less effective alternatives. And there's decreased productivity, they're stressed and distressed loved ones as they're looking after these patients who are in in pain, by inevitably leading to poor access to effective new therapies. The PMPRB have what I call irresponsible demand for bargain basement prices for Canadians, which means that Canadian cancer patients will have much greater suffering, much shorter lives, increased emergency room visits, increased hospitalizations, wasted expense of less effective therapies, and distressed and lost productivity of their loved ones. So effective new drugs are very expensive, but there are achievable solutions for this, and I've outlined those in chapter 13 of my book, we can do this, so what you guys are doing, you're trying to treat the symptom, we need to treat the disease and get to what's causing these if we're going to make this work. So, again, if anybody wants a copy of the book, by all means, send me an email, and I'll be happy to send you a copy.

Koebernick: [01:30:39] If I understand. Well, your book is your submission, so you can send it to me as well.

Peter Morland Giraldo: [01:30:47] Thank you so much, Doctor Stewart, for your advocacy on behalf of cancer patients across the country. I mean, there's so many people who understand completely what you're saying about the need you're facing a cancer. I mean, people are anxious for solutions, they want the best solutions available. And thank you for your advocacy on that, and it matters to all of us and it matters to all of Canada. So thank you for that. About nivolumab? Is that not approved?

David Stewart: [01:31:23] All drugs that are approved, but there are others that are not approved, like the inhibitors, RET inhibitors, Braf inhibitors  for lung cancer are not approved, and things that would be available in many other countries are not actually approved, so they're approved but not publicly funded here. And our big concern, so we've got many delays, we've got the delay through Health Canada, through CRA, through pCPA,  but then the other thing is that what we've seen, evidence of is that, with forcing down the price with PMPRB, that will actually reduce the number of drugs that even get submitted to Health Canada. So not only will people relying on public funding not get access, but also people that have insurance will not get access, if companies begin to apply less to Canada because of this and the other thing also, it may not be that they don't apply. They'll put us way down the list after other countries. So we'll be waiting for the Boxing Day sales for these drugs. But my patients are dying very rapidly. They can't wait for the boxes to sell.

Peter Morland Giraldo: [01:32:23] So perhaps you could help us. One of our recent publications is price meds and, meds entry watch, where we did an analysis. Exactly what you're asking about here. about 230 drugs that have been launched in other countries in Europe and the US. And of those, only 155 had come to Canada. And I think that's what you're saying that there's only 155 of those. But we did an analysis of the other 75 that didn't come to Canada. And you can see it in the report. But of those, 45 of them were not launched in any country other than the first country. There's 45 of the 75. And because a lot of these drugs are sort of the evidence is not entirely clear. And of those 155, there was only four drugs at the end of the day that were widely launched in other countries and not launched in Canada. So I take your observation, that some drugs are not being launched in Canada, but I think we need to have a discussion about this, but which ones are not being launched in Canada? Because, Guillaume recently sent me, a report of  a cancer drug that came to Canada, and I said, well, what are the international prices? And he said, there are no [01:33:36] [inaudible]. [01:33:37] This is a new drug that has no other international price, it's a cancer drug. I'm like, well, why not? He said, well, Canada was the first place it was launched. So, I admire your advocacy, and I want to get to the bottom of this problem, of this challenge of why are some cancer drugs not coming to Canada? but I think our view of the challenge is maybe somewhat different than what you presented it, up there. I just wonder if you have any comment or can help us understand.

David Stewart: [01:34:10] So, the fact of forcing down prices, will slow the probability of the drug being submitted to Canada, which slows access, and we think that there's likely to be an increasing number that don't come at all. And that slide I presented based on PMPRB data that very clearly shows that on average, that the higher the price that country is paying, the higher the proportion of those drugs. And unless the numbers get completely messed up, what that tells me is that if we mandate the drugs that must be cost less in Canada, that there will be fewer submissions, it costs almost $1 million for a company to apply to Canada to get a drug approved. Then they have to apply to help to get it. Then they have to apply to pCPA, and all of this take time and money and their staff that they're paying to work on this. And so if they've got a bigger market, Canada is a very small market, 2% of the international market. 
In the past, we've gotten rapid access because we've been willing to pay high prices. it becomes less if we don't. So I've made the point before that if we really want to get better access, cheaper, one very simple way is just to join the EMA, the European Medicines Agency, and stop having Health Canada approved. Health Canada does a good job, but the data are very clear that the European countries do better because the European Medicines Agency is reviewing things based on 550 million people. And they've got some very big markets like Germany and that are willing to pay a lot, so that so that's what gives them rapid access and a relatively lower price. But Canada, wo we're doing some things with Project Orbis of the United States, but that's only a minority of the drugs. And it does not get us the same thing as well. So that's one thing that we could do if we want to bring down the price. 
 The other thing that what the book really says is a factor that's driving high drug prices is an incredibly high cost of new drug development. so that  has to be recouped and the personalization. So it used to be that I could use one drug to treat all my patients lung cancer. Now I can only use it in the 1% that have that appropriate mutation, but it costs the same amount to get that drug approved for all lung cancer patients at that 1%. And that has to come from somewhere.
  So in the 1960s, it cost an average of $4 million to bring a drug to market, by 2013, according to the Tufts University assessment, it was $2.9 billion, that's rising much faster than inflation and it's all because of misguided regulation. Regulation is absolutely essential, absolutely essential, but there's a huge amount of waste there. And actually, Covid has proved it to us, if you set your mind to it, you can do it much faster, much cheaper, all you have to do is you need to have the willingness to do that,  that's treating the disease rather than treating the symptom, the high prices at your approach, very important, but it's treating the symptom rather than the disease.

Phil Azzie: [01:37:15] I Think you're at the time limit. Thank you very much, stay within it. Our next presentation is going to be delivered virtually. And so, it is going to be delivered by Oscar Jacobson, vice president, Patient Access, Novo Nordisk Canada Inc.. whenever you're ready, Mr. Jacobson. The floor is yours.

Oscar Jacobson: [01:37:36] I hope you can see and hear me now.

Phil Azzie: [01:38:11] The floor is yours, Mr. Jacobson.

Oscar Jacobson: [01:38:13] All right. Thank you very much. Hello, everyone. I'm Oscar Jacobson, as you can tell from my accent, I was born in Denmark, but I've lived in Canada the last seven years, and I'm proud to be Canadian. Before I settled in Canada, I have had a global career which has, given me exposure to many different ways of doing, pharmaceutical pricing. I'm representing The Nordisk today, a Danish headquartered company with roots in Canada. No Nordisk is owned by a foundation that reinvests its income into projects that improve health, sustainability of society and the planet. As an example, in 2022, Nordisk Foundation awarded nearly $1.5 billion in grants to such causes. The Novo Nordisk Foundation also guarantees that we have a long term commitment to defeat diabetes and other serious chronic diseases that are impacting millions of Canadians. We don't pretend to have all the answers, and we're deeply committed to partnerships with society, either through the foundation or through programs such as Cities Changing Diabetes. We believe that collaboration is best way forward, and it's in this spirit that I stand before you here today. I'd like to thank you for having me here and for listening to what I have to say. In the end of the day, the best results are developed when we truly listen to each other, and I hope the journey ahead will be one of collaboration. I'm here today with three simple messages I hope you'll take into consideration as you continue to develop the PMPRB guidelines.
 First of all, Canadians need innovation to defeat serious chronic diseases in a sustainable way. Secondly, in order to bring innovation to Canada, there is a need for predictability and stability. Third. As I said initially, collaboration is key, Canadians are served better when we're working together. When it comes to innovation, I'll bring you briefly back about 100 years. Frederick G Banting discovery of insulin is one of those defining moments that made Canada, Canada, and it's one of those defining moments that made the life sciences what they are today. In fact, it gave birth to the company I represent. If Banting lived today, I'm sure he would have been excited to see that we're closer than ever to finding a cure to type one diabetes through innovative stem cell therapies. But I'm also quite sure he would be greatly saddened to see the surge in obesity in the 1980s and the following pandemic of type two diabetes requiring new therapeutic solutions. Statcan recently reported a significant increase in the rate of chronic diseases amongst Canadians since 2015. That includes diabetes, heart disease and obesity. These chronic diseases negatively impact Canadians quality of life and lead to an increased rate of mortality. Innovative medicines have an important part in bending the curves for these diseases, transforming the lives of patients living with such serious chronic diseases and in reducing the burden on the health care systems. But in order to bring innovation to Canada, there's a need for predictability. Predictability means predictability in roles and responsibilities for each stakeholder, it means clear and stable guidelines and practices focused on the purpose of each stakeholder. And third, the ability to predict outcomes of the evaluations within reason. The Canadian health care system is unique and it's complex with multiple agencies and stakeholders, each with their purpose, guidelines and practices. Health Canada ensures innovation safe and efficacious PMPRB insurers prices are not excessive. Health technology agencies such as CADTH and Inis evaluate Pharmacoeconomic value of innovation, and payers such as the pan-Canadian Pharmaceutical Alliance negotiates confidential net prices to address affordability and budget concerns. Each organization fulfills an important and distinct role in pharmaceutical pricing. To maintain predictability, it is important that these organizations stay true to their purpose. While it's tempting to expand scope in pursuit of the greater good, such expansions can lead to unintended consequences. In particular, when the added scope overlaps with the scope of other organizations that are better positioned to carry out that purpose. PMPRB's role is to establish the maximum prices that can be charged in Canada for patented products. It's an important role, but it should not be confounded with setting the actual price, which also is called the net price, but there is a net price that is different from the list price in Canada, is a consequence of the unique complexity of having a private and public market, with many different stakeholders on each side that are all part of establishing the net price. In many other countries there is no such comparable distinction. Should the PMPRB establish a maximum allowable price at the level of such countries? The prices payers in Canada would need to pay would be more equal, but I'm afraid there will be less equitable because there will be less tailored to the populations of each payer. International reference pricing has a role to play, yes, but it's important to understand that it's like comparing apples to oranges or pears to bananas, as they say in Denmark, it's the same medium but very different fruits. Reimbursement mechanisms and the role of list prices are vastly different in each country. The most comparable market to Canada is Canada itself, given this complexity, it is important that the guidelines consider all factors within the Patent Act, including domestic comparators and CPI. Guidelines should enable companies to predict outcome within reason. Anyone who has managed a household budget will know the importance of income being predictable and stable. Pharmaceutical companies run households that fund large and very long time commitments such as jobs, production facilities and research and development. Innovators already take on a huge risk as [01:44:29] [inaudible] [01:44:30], as only one out of 10,000 ideas actually make it to the market. We need to ensure that the innovation that makes it to the market also makes it to the patient. And that brings me back to collaboration. I hope this hearing will be the beginning of a collaborative effort, where all stakeholders can contribute to making Canadians healthier and more prosperous. Thank you.

Peter Morland Giraldo: [01:44:56] Thank you, Mr. Jacobson. insulin has been a, one of Canada's strongest stories. And,  we appreciate Novo Nordisk has really is working extensively in the field, it matters to all of us. Insulin, I guess the Pfizer vaccine and Alexander Graham Bell and the telephone, I think those are Canada's three biggest inventions in the last century and a half. So thank you. The ability to predict and to predict outcomes, I think that that's a very reasonable approach, because what we do with our new guidelines is we, develop staff processes, to make it clear what the staff's going to do. And then I take it someone like Novo Nordisk can also look at those staff processes and understand what risks, what challenges. You might  want to take a price that's, slightly higher than, because you have a justification for it. Alternatively, you may want to come in at  something that's easy for this board to approve, at a price that's maybe, slightly lower, and noting that in box two, of our, scoping paper, 34% of new medicines coming to Canada have prices below the MIP. So I'm assuming in those cases that organization has some reason, why they want accelerated approval and their competitive position in the marketplace, they're willing to come in below the MIP,  and that's significant, 34% of them, do. So this kind of pricing clarity  and certainty, I hear your appeal for that, and I just wonder if you can give us any more color on that, predictability and what that means to your organization.

Oscar Jacobson: [01:46:49] Yeah. So I'm not sure what the products you're referencing really are, because that could be [inaudible] products, for instance, and I really can't really answer for that. But one of the things I can answer for is that we need to make sure that there's predictability throughout the patent life of our products because, one of the worst things that can happen to a pharmaceutical company is that we see that the products we spent so much time on innovating and developing never reach the patient. But the worst thing to that, the most awful thing that I've experienced in my career, is when you have to take a product off the market again, and you can see that happened in the past in Germany, you could see it happened in Greece, and it's the worst ever when you actually introduce a product only to, find out that you can't meet each other with the price regulator and then you end up having to take it off the market. So that's what I would really, make sure, I really like you to consider is that we need to make sure that we meet each other, and then we stay, you know, aligned throughout that patent process or patent life.

Peter Morland Giraldo: [01:48:01] Thank you. You don't want to lower, sometimes the price you come to market with, though, if I'm not mistaken, it's based on the promise of therapeutic value. And this is a term we've heard from INESSS, in Quebec that focuses on that. The price you said is because you believe it will bear out in time. But sometimes the evidence is not precisely clear at the start about whether there really is that value there. So, we might approve a price initially, early on based on the promise of therapeutic value, but that evidence may not bear out, well, maybe it will, as Professor Lexchin said, it'll bear out and you should come back with a higher price three years from now, but on the other hand, if the evidence doesn't bear out, maybe you should, maybe it might be an excessive price. If the evidence doesn't bear out. Now, do you have any solutions for how this board should deal with that problem?

Oscar Jacobson: [01:49:06] Yeah. So I have a couple of comments to that, the first one is that we see in other countries that they are willing to take a price increase, for instance, in Germany based on, value. I have still to see any payer doing that in Canada, I've just not written that at all. What I do know is that we have many trials ongoing for products that we actually do have approval or instance, we have, a select study coming out where we had to study 17,500 patients, and that established a value for a product. I doubt that these, trials will help us establish a higher price, in Canada, because the Canadian system, the reality is that it's very asymmetrical in the way that it's very skewed towards lowering prices, but not really, helping in increasing prices. And the last thing I'll say about it is that there is INESSS, as you, mentioned, there's also CADTH that are already taking into consideration the pharmacoeconomic value, and that is reflected in then the subsequent negotiation with the pan-Canadian Pharmaceutical Alliance, that are leading to net prices, but these net prices do of course, reflect, affordability considerations and the value of the product.

Peter Morland Giraldo: [01:50:27] Thank you very much. And I would just like to make a comment. I think I may have misspoken previously when I said this board approves prices, we only identify non excessive prices.

Oscar Jacobson: [01:50:38] I do understand.

Peter Morland Giraldo: [01:50:40] Thank you for that. To not challenge me on that, but I know you understand. Okay. Thank you so much.

Phil Azzie: [01:50:50] Thank you very much, Mr. Jacobson.

Peter Morland Giraldo: [01:50:53] Thank you so much.

Phil Azzie: [01:50:55] I'll now call on our next presenter, Jason Lamb, director of government affairs and market Access, Paladin Labs. And the floor is yours.

Jason Lamb: [01:51:04] Everybody has laptops or speaking notes with big fonts, and here I am with, my little phone. A few more years before, to move to a laptop.

Koebernick: [01:51:16] [unintelligible]

Jason Lamb: [01:51:20] It was not meant to be a backhand.

Koebernick: [01:51:23] It wasn't, it wasn't.

Jason Lamb: [01:51:26] Thank you PMPRB and distinguished members for the opportunity to engage in meaningful dialogue, on an issue that has impacted our industry for seven years now. my name is Jason Lamb, and I am the director of government affairs and market access at Paladin Labs. Paladin is a leading Montreal based specialty pharmaceutical company focused on acquiring or in-licensing, innovative medicines for the Canadian market. We build solutions based partnerships by focusing on late stage, product development to address the unmet needs, medical needs in Canada. Our members. 
These questions issued by PMPRB were challenging to address, not because we couldn't take a first pass at answering them, but because they were often specific, and could be answered in multiple ways if different assumptions or frameworks were assumed, and so it perhaps it would be overly simplistic for us to address these questions in detail in this form without some in-depth dialogue on the policy objectives PMPRB is trying to achieve with its price review mandate in mind. So rather than, attempt to answer each specific question superficially, although you might catch me afterwards on that,  15 minutes allotted time frame, I want to focus on three key points. 
 Number one, the PMPRB principles need to be upheld in the design of future guidelines. Number two, and this is somewhat unique to us. Unpredictability has had a unique impact on pharmaceutical companies that operate as in-licensing and acquisition models, with mandates specific, to addressing the health needs. And then number three, it is critical that a technical working group with patentee involvement be established.
 On point one, the first question in the scoping paper, question 1.1 I found very striking. That is what elements of the 2010 guideline should be retained. Paladin’s answer is emphatically PMPRB's commitment to update the guidelines to ensure that they uphold the principles of fairness, transparency, openness and predictability. This commitment can be found in the first section of preamble of the 2010 guidelines. Let's keep that as the basis upon which we approach subsequent engagements and guideline implementation. So to start, I do want to commend, PMPRB's commitment to the principle of openness  with this policy roundtable. It's a great restart,  and certainly a catalyst for a more informed, focused and productive consultation process. We should follow in this direction under new leadership, to uphold PMPRB price review mandate, that is, to ensure prices for patent medicines sold in Canada are not excessive. A keyword that others have talked about quite a bit. And that those principles lead us to fair to final guidelines. In my opinion,  and all due respect to the PMPRB, it was really when PMPRB strayed from its principle of predictability, in drafting guidelines, that negative consequences resulted. And this leads to my second point, unpredictability in PMPRB's direction and guideline modernization over the past seven years, past seven years has had a profound effect on our Labs, on all patentees. As I mentioned previously, Paladin's business model is based on acquisition and then licensing, medicines in Canada only. This means that we here in Canada partner with mid-sized or biotech companies that do not have a presence in Canada or never will. And we bring those innovative options, medicines and investments through clinical trials or whatnot into the country. And in the past seven years, we've had to forego several opportunities to partner up because pricing was uncertain, which translated into potential product launches with unknown sustainability over life science. I personally had to look at recent business development opportunities, but advised internally that the PMPRB risks just outweigh the opportunity.  We've also had to look at our current portfolio and stress about CPI increases, not keeping up with large increases in cost of goods recently charged to US by suppliers due to Covid, supply chain shock and whatever else will come next. Which is made more difficult due to uncertain or vacillating PMPRB positions on CPI increases. And finally, we've had international partners simply walking away from Canada once we tried explaining the proposed PMPRB reforms and their uncertainties. Many of them are not sequencing international launches to optimize pricing under PMPRB framework. You've mentioned a few that have launched in 1 or 2 countries. Some of them are not even familiar with PMPRB at all. We need predictability and new guidelines badly, or else innovation launched in Canada may slow down, especially those brought in through licensing or acquisition,  by companies like Pattern Labs. And ultimately, as Doctor Stewart was mentioning, the clinicians toolbox becomes more and more obsolete over time. 
 My third and final key point is this to achieve fair, transparent and predictable guidelines, [01:57:53] [inaudible] [01:57:54] strongly advocates for technical collaboration with patentees and other interested parties, perhaps a technical working group is a more suitable forum to work towards final guidelines. It has been, as some have mentioned it has been used before to update certain aspects of the 2010 guidelines, and I hope PMPRB is open to that idea again. The work will be challenging, no doubt, and require an iterative process to address all the questions and associated implications set forth in the scoping paper. However, if we do not do the work, we risk repeating history. When there was significant pushback after the issuance of the first version of the draft guidance back in 2016, which were brought forth without providing much detailed consultation in advance on the technical aspects of the draft. The fine details and navigating the fine details of PMPRB reporting for part of my responsibilities, back then,  with the help of some skeletons in the room. And for those of us who understood the technical ins and outs of the 2010 guidelines and the changes proposed and the radical shift proposed in the first draft, it became apparent very quickly that the new draft guidelines made little sense, made implementation impractical, and or created a sense of creating more confusion and uncertainty than anything else. We need technical experts who can think through the drafting of new guidelines and the implications on drug pricing in the life sciences ecosystem. So let's solve the seven year quagmire together,  through constructive and collaborative engagements, by taking the step in establishing a technical working version. Thank you for your time and I look forward to next steps.

Koebernick [02:00:01] Thank you, Mr. Lamb for this presentation.   I've been in the ecosystem for 20 something years, and I have to say that when you said the PMPRB risk outweighs the opportunity, my eyes open because I'm like, okay, I understand Canada’s complex ecosystem with ten provinces, three territories, Health Canada, CADTH, INESSS, pCPA, when you have to explain that to, a company outside Canada, I can see the complexity there. But to say PMPRB risks outweigh the opportunity, I need you to elaborate on this and give me and explain to me how that is actually the key factor that makes opportunity go down.

Jason Lamb [02:00:48] And this, maybe I spoke too strongly about it, it is not the only factor. But let's be honest, it's not the only factor that we consider, but it is a major factor. When we have relied on past precedents, either through investigations or cases that have been solved, there was a level of predictability. The guidelines were well realized in 2010, and there was a level of predictability. In the past seven years, we've not been able to rely on that, even the PMPRB database for previous investigations is no longer available. There is no guiding principle or support for companies like us to define the list price. To base our whole business model for a launch. I mean, anybody who has done the finance. You start to grow revenue and work your way down to set the gross revenue, you do need to understand, to have certainty.

Koebernick [02:01:57] I have a question for you. I know we're talking about certainty, predictability and you were quite emphatic about the need for a working group. So we're now in some time since we've had new guidelines, we have interim guidance. How long can you live with interim guidance, which is what you'll have to live with while we put in place, assuming we choose to do that, technical working groups which can also, we all know working groups can go on for a very long time without some clear parameters and time frames. So I understand the call and the need to have the right people around the table to crunch these issues. It's very key for everybody and everybody wants to participate. But these things do get dragged out and then people are still living in uncertainty. You have interim guidance. You don't know what's going to happen when the interim guidance is over. What will happen? Will we go back to the issues of grandfathering? I mean, there are many issues that I think of now, so it's something that we have to think very carefully about at some point, and to go about getting things right. I think we serve only about…  we also need to have time frames established. And you don't have to answer that. What they should be, I'm just curious from you. What would you say to something like that. Can you work with deadlines? Because sometimes… 

Jason Lamb [02:03:44]  We all work with deadlines. So, I do just defer that Declan, what he said getting it right is perhaps more important than getting it done now. And hypothetically, as we pushed through the first draft guidelines, I think you would have much, many more issues and challenges and, consequences, because there was no initial, consultation or technical group put in place. So the alternative to that might be what was happening with the first draft and was not successful. So I think the solution is in the technical working group. Obviously, you know, there has to be, some level of expediency to it. But it's important to get it right.

Koebernick [02:04:43] Thank you, I appreciate that.

Peter Morland Giraldo [02:04:44] Thank you both excellent questions were top of my mind. But just, let me say one quick comment as we're closing. This board is unique in the world, there is no country that has a board like the PMPRB. And, I did give a brief, short course primer on that at a conference yesterday, and I'd come online probably in January when we get the translation done. But that is something that you could send to your international peers and your head offices, which said, and you can serve all the easy parts that explain what this board does, because we understand it's an issue internationally, people do not understand what this board is. Most other countries have federal pricing authorities, which do set general average prices across the country. This country does not, it's, due to the wisdom of 36 men in 1864, in Charlottetown, they put all that responsibility down at the provincial level and, very little, responsibility, well, not little, but, yes, at the federal. So, we do understand the confusion that sometimes causes. Thank you.

Phil Azzie [02:05:58] Our next presentation will be delivered virtually. Sharon Batt, adjunct professor, Dalhousie University. Co-Founder and member of Independent Voices for Safe Drugs. Okay, Professor Batt, the floor is yours when you're ready.

Sharon Batt [02:06:22] Okay, am I on now?

Phil Azzie [02:06:24] You are. Can you hear us?

Sharon Batt [02:06:27] Yes I can.

Phil Azzie [02:06:28] There, The floor is yours.

Sharon Batt [02:06:29] Great. Thank you. Okay. Good morning, and thanks for the opportunity to speak today. As I was introduced, I'm sharing that I'm affiliated with several academic and advocacy organizations involved in drug policy. But today, I'm speaking here as an individual. I received no funding from the pharmaceutical industry, and none of the projects I work on are industry funded. My interest in drug policy began with my first cancer diagnosis 35 years ago. Professionally, I've worked as a journalist, an academic, and a cancer patient advocate. My current work combines all these roles. For two decades, I've studied and written extensively about partnerships between patient advocacy groups and pharmaceutical companies, and the policy implications of these alliances. This interests informs my engagement with the PMPRB and drug pricing. Six years ago, I joined with a group of colleagues from across the country to form Independent Voices for Safe and Effective Drugs. IVSED for short, we became regular interveners supporting the PMPRB regulations and proposed guidelines because we were dismayed by the lack of public sector interveners, arguing that Canada’s high drug prices must be reined in. Our prices have long been the third highest in the developed world, and I understand we're now in second place. Our prices have long been the third highest in the developed world, and I understand we're now in second place. Unfairly priced drugs are obviously a problem to the people who need effective medications and can't afford them. But beyond those affected directly, all Canadians have a vested interest in a publicly funded health care system that's fair and sustainable. Excessive drug prices distort the allocation of public resources across the board. Now I'm not a patent holder, so my comments are primarily addressed to theme six of the scoping paper. The PMPRB's engagement with stakeholders who are not rights holders. But I find the term and concept of public interveners and stakeholders both misleading and a source of problems in the PMPRB's efforts to engage with the broader public. I would urge everyone at the PMPRB to read a short article called Vanishing Stakeholders by Joshua Sharfstein. Doctor Sharfstein is a former senior administrator at the USFDA. He writes that in health policy, a catch all phrase like stakeholder obscures the landscape by putting lobbyists in representatives from industries with financial interests in health policies on the same footing as those advocating for the public interest. As participants in the turbulent process about the PMPRB guidelines over the past years, my colleagues and I felt this false equivalence keenly. Doctor Sharfstein describes the rise of a stakeholder management industry, the council's health policymakers in how to make stakeholders happy. But the purpose of good health policy, he says, is to advance the health of the public at reasonable cost, not to please stakeholders. So this critique recognizes two different value systems in health the public and the private. Lawyer and ethicist Jonathan Marx takes up this dichotomy in an interesting book called The Perils of Partnership. Governments, including ours, have blurred the boundaries of public and private interests with a policy culture that encourages partnerships between private corporations and the agencies tasked with regulating them. Marx argues that these partnerships inevitably weaken public health policy, because the core responsibility of government health agencies should be to actively guard the public health. In order to do this, public health agencies may have to engage in struggle and even direct conflict with private companies whose core responsibility is to sell their product. Marx emphasizes that engaging in conflict with the private sector is not about demonizing the industry. It's simply recognizing that both parties have responsibilities that are fundamentally at odds. The private sector has enormous resources and deploys well-honed, profit seeking strategies to achieve them. The partnership culture that Marx worked warns of is alive and thriving in Canada's health system. I was dismayed, I have to say that the appointment of individuals from the private sector to the two top positions on the PMPRB board. Echoing Marx, this is not to demonize you, Thomas Digby or your vice chair any Perreault but I don't see how you can engage in the struggle necessary to bring down Canada's excessive drug prices when this means confronting your colleagues in the pharmaceutical and biotech sectors. Patient advocacy groups are also part of the partnership culture, partnerships between patient groups and pharma companies are central to my research and advocacy. Scholarly and journalistic accounts of these partnerships are now extensive, and the findings are consistent and concerning. Patient advocacy groups have become a powerful force in shaping drug policies throughout the high income world, most of these groups now accept funds from pharma companies. Some have staff and board members who worked or currently, or did work for pharma companies, transparency about these relationships is inadequate, but the groups intervene regularly in drug policy arenas to support the goals of the industry, including demands to place new drugs unequivocally on state funded formularies and on the topic of excessive prices. Patient groups funded by the industry typically either side with the industry or are silent. So I wasn't surprised to see the extent to which patient advocates opposed and even attacked the PMPRB  in its bringing forward these, proposed guidelines. But I'm concerned a less engaged observer might well conclude that patient advocates in Canada don't think our high drug prices are a problem, but maybe  that's not the case. Last May, an organization called Patient View, based in the UK, released its most recent report on what patient advocacy groups in Canada think of the pharmaceutical industry. Patient view conducts these annual surveys of patient groups around the world, asking them what they think about pharmaceutical companies. Last year, they surveyed 122 patient groups in Canada, 93% of whom worked with pharma companies. Participants who could respond anonymously rated pharma companies on 14 skills, including whether the companies had fair drug pricing policies.  I didn't use my slide, but, you can find this, report online. And of the 14 activities rated, fair pricing ranked dead last, only 20% of 122 groups said that pharma's pricing policies in Canada were good or excellent. Patient views of report discuss the recent events at the PMPRB and said high prices and access to medicines were they quote predominant worries for Canadian patient groups. Curiously, these concerns aren't reflected in the patient advocacy group submissions, over the years to the PMPRB or in comments in the media by leaders of these groups. The most dramatic example of patient advocacy opposition to PMPRB concern the drug Trikafta for cystic fibrosis, a new entry to the Canadian market in 2021, and the prime example of a drug that merited public discussion of price Trikafta is highly effective, however, vertex, the company marketing the drug, garnered international headlines for pricing the drug get over $300,000 per patient per year. One research team estimates the cost of production at less than $6,000 U.S. per year. Yet while CF group's internationally protested vertex, it's pricing, patient advocacy groups in Canada instead attack the PMPRB's proposed guidelines, which the company initially cited as a reason not to bring the drug to Canada. This seemed to me like fear market mongering and patently ridiculous, of course they would market Trikafta in Canada and they did. Yet instead of calling the company's bluff advocacy groups attacked the PMPRB even intervening to support the industry's case against the PMPRB in the Quebec Court of Appeal, every province or territory in Canada has now funded Trikafta, as they should. But is Canada paying a reasonable price? I don't know if Canadians are paying more than other countries, but the advocacy of patient groups here surely undermined the ability of provinces to bargain for a fair price. In the latest [inaudible] report states that Trikafta was a top contributor to increased spending by public drug programs in Canada in 2022, $225 million, spending on Trikafta accounted for roughly 25% of the increase in public drug spending. In closing, if the PMPRB wants to engage with members of the public who are concerned about drug prices and are willing to say so, the agency needs to revamp its consultation processes to recognize that we're not all on an equal footing. I would suggest that you arrange regular meetings with public interest groups that are independent of the industry. I also think all participants involved in public engagement should be required to declare their financial and personal relationships to the pharmaceutical industry, and the groups representing the public interest that don't receive industry funds should receive support from the PMPRB if we're going to engage in your processes, I also think the PMPRB's current mandate needs to be clarified. Is the agency's mission really to protect the public health? If so, PMPRB board members should be independent of the industry. PMPRB staff should be barred from revolving door employment with pharma for three years. But if the if the PMPRB’s mission is to make stakeholders happy, the PMPRB should publicly acknowledge a change in direction. That's my conclusion.

Peter Morland Giraldo [02:16:50] Thank you, Ms. Batt. We are very familiar with your work at the PMPRB, and, and we appreciate your multiple submissions along these lines. We appreciate your advocacy for public health in Canada, we know  it's a lonely business sometimes, but all Canadians, I know many Canadians, appreciate the efforts you make on their behalf to bring these issues forward to an important, board like ours. I just want to check in on a couple of constitutional matter. You've asked if our mission is really to protect the public health in Canada, and. Well, it's tempting to think we might have that mission, we really can't say we do, excuse me, I can't say we do. Our mission is really much more limited to preventing excessive pricing in Canada, which does not give us a general mandate to intervene in public health overall,  and do you have any thoughts on that? I mean, you think we should, use the scope to the extent we can, but I think it will you be okay if we can't quite solve all the problems in Canadian public health care?

Sharon Batt [02:18:10] Yeah. Of course. Yeah. I mean, I was referring to the impact that excessive pricing has in the kind of ripple effect on, you know, the spending, the public spending purse there's only so much money, if we're spending on drugs, then there isn't enough money for other purposes in the health venue, but also in other areas like housing, which also have effects on health. So I just see  the drug pricing which is excessive. I think there's enough evidence to say that, in a broad sense, it has broader impacts.

Peter Morland Giraldo [02:18:57] And thank you. We do note your comments about, the experience and background of, some of the board members. And I just want to highlight,  we are all aware of our roots, and there's five members of the board, some from different sectors, when we in fact, we were appointed precisely because of those backgrounds. So, I guess the metaphor would be, if you want a board that's going to manage air traffic control, you would like to see at least some of those members who know something about air traffic control. But I can confidently say that we do not have any bias for or against any party that's coming to our table here today or in the course of our regular business, our intention is to represent Canadians as best we can on the basis of our knowledge and our experience. Are we okay with that?

Sharon Batt [02:19:59] Okay.

Peter Morland Giraldo [02:19:59] So we thank you so much, miss bat.

Sharon Batt [02:20:01] Okay.

Phil Azzie [02:20:07] We will now proceed to the final presentation of today's morning session. Angelique Bergh, president and CEO, Canadian Association for Policy Distribution Management. And, I see that, that Bergh is online, not in person. So we will connect you and, as soon as you are ready. Angelique Bergh, the floor is yours.

Angelique Bergh [02:21:10] Good morning, everyone. You hear me?

Phil Azzie [02:21:12] Yes. We can. Please proceed.

Angelique Bergh [02:21:15] Thank you. Good morning, Mr. Chair. Madam Vice chair and member Koebernick. My name is Angelique Bergh and I am the president and CEO of CAPDM, the Canadian Association for Pharmacy Distribution Management. CAPDM is the nation's trade association for distributors that channel over 95% of the medicines our country consumes, and I speak to you today from the Treaty Lands of the Mississaugas of the Credit First Nation, the traditional territories of the heart in Haudenosaunee grateful for the First Nations stewardship of those lands. Land acknowledgments at captain have a meaningful resonance, as our members are the very companies that deliver medication to all corners in Canada, from dense downtown cores to our most remote towns and sparsely populated indigenous communities. Functionally, pharmaceutical distributors streamline orders and deliveries between hundreds of drug manufacturers and over 12,500 hospitals and pharmacies, allowing vital medications to the majority of our nations communities on a next day basis. Key among their roles distributors act as a short term buffer against drug shortages without their inventories and their safety stock, there would be far more drug shortages well beyond the 100 they deal with every week with their trading partners, who also form our membership, pharmaceutical distributors form our efficient, accurate, reliable and safe supply chain that ensures physical access to medicines for all Canadians. It's on their behalf that I thank you for this opportunity. We fully respect the mandate of the PMPRB  and we support the affordability of medicines, and we realize that we're not a primary stakeholder in this event. And so we thank you very much for giving us some time today. We are deeply concerned, however, that striving for low prices, to the exclusion of all other considerations, that physical access to medications is now at risk, particularly for those living in remote rural areas. With those communities firmly in mind, I will share our comments which relate mostly to themes one, two and six, and with the objective to raise awareness and raise some friends on understanding the fragility of the supply chain in Canada, we realize the PMPRB is not going to solve this problem, but we'd love for you to be friends and voices for us in in as we try to solve those problems. So first, some context on how pharmaceutical distribution is funded, understanding that it's far more complex than there is time for it today. But I'd be pleased to meet with you after and provide more context. Pharmaceutical distribution is largely funded as a factor of listed drug prices, thus, the lower drug price, the less funding that is available to get the medications to the patients who need them. An illustration of that effect, generic price reductions have reduced pharmaceutical distribution funding by over $50 million per year, or 800 million since their downward trend began in 2007. That's a significant number and a significant challenge. Ours is a controlled market where funding is limited, yet operating and regulatory costs are uncontrolled, subject to market forces like inflation and fuel costs and labor costs. And it creates quite a pinch point. The cumulative impact of price reductions and increased costs are estimated to be over $100 million annually, threatening the fiscal sustainability of Canada's pharmaceutical supply chain. The supply chain is at a precipice, and we can't stress that enough. With drug pricing could soon be a moot point for remote and rural communities, and I'll explain that in a minute. Medicines might be affordable, but it doesn't much matter if you can't get them. And so with that context, our place on what price level should be used as a triage measure, we urge at least HIP drug prices presently are the core number against which distribution supply chain actors are funded. In today's system, the lower the drug prices, the weaker the supply chain. In Canada, that weakness is exacerbated by our great size. Consider, for instance, the cost of transportation outside Australia. Just using the PMPRB 11 countries for a physical comparison of ten of those 11 countries could fit inside our national borders without spilling into any surrounding seas. The costs of getting medications from those individual countries to their furthest outpost is much different. Say, then shipping from Montreal to Yellowknife. Traversing our country is enormously expensive, and funding to do it is predicated on the price of the drugs. However, Australia, which is closer to Canada size and population density, recognized that challenge after only a breaking point in their supply chain. In 2006, they created a supplementary funding pool of $200 million per year to distributors to uphold the service standards their country expects. In their words, the fund was to make it commercially viable for distributors to supply medicines across the country, because it wasn't, they had to make it commercially viable. Canada right now has no such funding pool, and we don't suggest that creating one is in the  PMPRB mandate unless they can, then we'd love that. However Australia's example does show how important it is that the supply chain actors and their regulators understand  the impact of low drug pricing on and its enabling systems. Until everyone recognizes we have a problem and advocates for a solution, we can't solve it alone. And we're stuck with today's system where funding is a factor of the drug prices. So, unsurprisingly, we urge that PMPRB target at least HIP for determining excessive pricing. Likewise, we strongly recommend  that the pricing of existing medicines be grandfathered if they've already been deemed as not excessive. In the earlier mentioned generic price decreases, and that reduced funding by over $50 million annually distributors had to responsibly cut costs just to stay in business, and there's not a lot of them. And I stress that they optimized optimization, but closed distribution centers, they eliminated daily deliveries to some areas, reduced safety stock and more. And I've done so successfully with very little impact to Canadians to date. But that's simply because they run so efficiently. Distributors now have few, if any, options to compensate for further lowering drug prices without Canadians really feeling it. These options won't happen overnight, but they will happen. Distributors could eliminate money losing products, creating difficulties for pharmacists and patients, and for prescribing physicians. They could further reduce the expense of safety stock, which is very expensive to carry. But that would eliminate all but eliminate any meaningful ability to prevent or mitigate drug shortages, could eliminate delivery to regions that are financially unsustainable, requiring that patients travel further to access their medications. And if you are in remote communities or closer to our northern borders, that's a very long distance, we could reduce delivery frequency to those same unsustainable regions, causing delays in starting new therapy or accessing refills. These cost reduction measures, they will impact every single step in the supply chain from manufacturers, straight through providers and to patients. And ultimately, it'll impact the health of our citizenry with those in remote and rural areas for us to feel it. So we urge the grandfathering of existing medicines. When we think about how the PMPRB can better engage with you. We actually really appreciate the consul that the PMPRB has given us in past. I'd like to acknowledge Tanya [02:29:08]Potashnick, [0.0s] who has been available to us on an ongoing basis. We also acknowledge that the PMPRB is many new leaders and respect your dedication. When it's been a noisy environment and we respect your appointments at this time to help us find new objectives, a new way forwards. CAPDM’s objective is to be a catalyst to solve our 9.8 million square foot problem, and we have yet to realize any great traction in that. And so the prospect of further lowering drug prices right now  is anxiety inducing in this entire industry. Do you picture remote community pharmacy? And they  are the only game in town and there aren't multiple distributors clamoring for its business? Then factor in the expense of shipping from a provincial capital to that pharmacy guarding against the weather extremes that we have. Monitoring temperature all the way through and all the other regulations that go along with it that distributors servicing that pharmacy, doing so at a loss. If there are any further drug charge reductions for industry firm focused only on profit distributors would have already implemented all of those cost saving measures to the extreme, and that pharmacy's business would crumble and close. And where would that leave the patient? And that's the sort of problem we're trying to challenge, we're coming up against. We've tried to sound the alarms, but we failed in a lot of ways in a number of different organizations. We are getting some voices, we are hearing some interest, but we need all the support we can get. And more than anything, we need time. We regard the previous  PMPRB model with equal optimism protect, empower and adopt. And we bear those in mind of summary recommendations. First, unlike Australia, the only means of funding pharmaceutical distribution in this country is based on a factor of the drug price. Drug price reductions mean reduced money for the enabling supply chain and lesser service to Canadians, particularly those in remote and rural areas. Drug pricing reductions in our current system today worsens drug access. So for that reason, We urge the PMPRB to target at least HIP for determining excessive pricing to grandfather existing medications. And we hope that you'll join us and had your support and your voices to calling for a sustainable system that enables the drug supply system as much as affordability in Canada's system today, drug place prices and supply chain operability are inextricably linked. This year, pricing decisions directly impact accessibility. We sincerely hope to collaborate with you to ensure affordability of medicines and their accessibility. We believe that's possible and we'd love to work with you to do that. Thank you.

Marie Thomas [02:32:00] Thank you very much. I've. I've learned quite a bit, I actually didn't know,  I didn't understand all the impact on distribution and pharmacies. And I need to understand a little bit more. And I hear you when you say you could give us a crash course if we had a longer time. But do I understand well that all of your business case is based on the list price of PMPRB and why is that?

Angelique Bergh [02:32:40] It's not.

Marie Thomas [02:32:41] Why did you choose that price? Because you seem to make a connection between the list price,  we would have deemed not excessive and all the rest of your business. And I was just wondering why have you chosen that list price?

Angelique Bergh [02:32:57] Oh, we don't use it. Oh, but if we could!

Marie Thomas [02:33:02] No, I  know you didn't. Why did you start from that price? Why it is that price that is so important?

Angelique Bergh [02:33:11] So it's all based on the on the allowable markup that is controlled by the provincial governments. So it's actually not the list price that the PMPRB sets, but the lower price that the provinces negotiate on, and then the small upcharge, so that is allowable in the provinces for that for the cost of that drug.  Did I answer the question?

Marie Thomas [02:33:32] Yes. Thank you.

Angelique Bergh [02:33:34] You're welcome.

Koebernick [02:33:40] I do have a question or comment, but it's  not really for you, I think I'm struck with, so don't take it as a personal comment, you know, to your organization or to any organization. It's just I'm struck by what I'm hearing is, and I'll generalize here. It's important to keep drug prices high because otherwise we can't get products into Canada. That's being simplistic here. And I struggle with those Canadians who, of course, don't have private insurance and the drugs carried out by public payer. So, how do they get those drugs? And I know some of the industry supports patients absolutely, but there is a high percentage of Canadians who don't get medications, so I struggle with that you know, I and I understand the business cases that people are making, and yours is an excellent business case, I truly understand. And I heard what the doctor said here today and that I was wondering what sharing that would say you know, and that you would have a discussion because she isn't in favor of higher drug prices, from what I understood from her presentation.  And, anyhow, I'm just sharing that with you, I struggle with that, so  we have that, tension in our organization when we understand, you know, what your drivers are. We also are looking to Canadians who aren't able to get medication. I'm just gonna leave that, it was an observation  and you  can comment if you have a comment.

Angelique Bergh [02:35:17] I think I sincerely appreciate the comments, and I do from two perspectives turn back to her that she's a cancer survivor, and so am I. And so the access to affordable medications is critical when you see all the different brands and such and all of the equipment that's giving you your chemo on the blister packs, your husband is popping out for you in gloved hands. You are so grateful for the people within the supply chain, the regulators, they keep the drugs affordable, the regulators who keep drugs safe in that supply chain safe. And I don't have any solutions for you, we need to create them, and we need all stakeholders to take a look at that and really thoughtfully consider this country is vast and we're sparsely populated, and there's got to be better ways to do this. And so what we're asking for is your support and adding your voices, connecting us with your friends. And in helping us to bring about be the catalyst and to solve this problem of supply chain in Canada and make sure that we have that affordability on balance with accessibility.

Phil Azzie [02:36:24] Thank you very much for your presentation.

Angelique Bergh [02:36:26] Thank you.

Phil Azzie [02:36:32] So we are now at the end of the morning session and we are exactly on time. So we will break over the lunch period and reconvene at 1:30 on the docket for present,  declaring the morning session ended. Thank you very much. Well, actually, our first presentation this afternoon is Kim Steele, director, Cystic Fibrosis Canada and vice chair of Best Medicines Coalition. The floor is yours.

Kim Steele [02:37:21] My name is Kim Steele. I'm the director of government and community relations for Cystic Fibrosis Canada. And I'm also, as mentioned, the vice chair of the board of directors of Best Medicines Coalition. The Best Medicines Coalition is a national alliance of 30 patient organizations which together represents millions of Canadian patients. We welcome the opportunity to provide input, into the PMPRB scoping paper. On the cost for the consultations for the board's proposed guidelines, the Best Medicines Coalition, or BMC, has been an active participant in the consultation on pharmaceutical pricing reforms and the PMPRB since modernization efforts were initiated by Health Canada in 2016. My remarks today will be focused on two themes. The first is how we, as patient organizations and representatives, believe we can best provide feedback into this consultation process and what we need from the PMPRB to do so.  The second will frame the overall core position we have taken on drug pricing that we hope will help guide the PMPRB as these guidelines continue [02:38:35][inaudible]. [0.0s] The Best Medicines Coalition and the organizations that belong to it are not large organizations. We do not have intensive in-house drug negotiation pricing expertise, and that is not our purpose. With the challenges that we already have funding our core activities, this is not really an area that we would have the finances to support, even if we wanted to. We received little to no funding from governments or the public sector. Rather, we rely on personal and corporate donations to support our work. If such funding existed, we would gladly seek it to support our efforts. Our restricted funding sources have not come without controversy from the PMPRB, which has in the past taken issue with the corporations that have supported the work that our organizations do. For instance, at CF Canada,  we have advanced cystic fibrosis research and care that has more than tripled life expectancy for Canadians with CF. We've contributed to the global body of knowledge funding research achievements such as mapping the gene for cystic fibrosis in 1989 at SickKids hospital here in Canada. This work led to the development of the transformational therapies that are today changing the trajectory of cystic fibrosis and most importantly, the people who live with it. This includes a new drug mentioned earlier by another panelist that is getting people off of the lung transplant and getting home and living people once on disability or going back to work in school and children have hopes and dreams their parents never thought they'd see. But this drug almost didn't come to Canada due to the ongoing reimbursement uncertainty associated with the PMPRB regulations and guidelines. Almost 40 countries funded this game changing medicine before we did. We work very closely with our international patient group partners and countries that had access before us. I wonder what's going on in Canada, during this time of uncertainty Canadians with CF grew sicker, irreversible damage was done to their bodies and we lost people along the way. These lives have been saved if they had the drug gotten to them, the sooner. We advocate for accelerated access to life changing CF medicines that have been diligently reviewed, approved and listed through government regulatory and listing processes. We also advocate to drug manufacturers to bring clinical trials and drugs to Canada, to provide patient access programs to help patients access drugs, if our public or private systems do not. We did all of this and more to get this transdermal drug to Canadians. And when it did come to Canada, it moved at lightning speed. From the time  Health Canada application went in to all public drug programs, reimbursing the time from application full reimbursement was 11 months. Through the pCPA our public drug programs expedited their negotiations, landing on a price they were comfortable with. They weren't comfortable with the price they wouldn't pay full stop. Cystic Fibrosis Canada is a leading organization with a central role in engaging people living with cystic fibrosis parents and caregivers, volunteers, researchers, and health care professionals. If our organization is not there for those impacted by CF, they would be left with little to no support. So what the PMPRB has criticized patient organizations directly and publicly in the past, without consideration to the ethical guidelines we have in place to protect the independence of our work. We would challenge the PMPRB to better understand what patient organizations do, how we operate, and recognize the capabilities we do have with the funding that we do have. The Best Medicines Coalition is here to help improve the health outcomes of the patients we represent, that is all we're trying to do. And we believe the ability for our health system sustainably support patients. The patients we represent is paramount, to that end, we are unable to provide detailed responses to the questions posed in the scoping paper. Our organizations do not have that expertise, nor the capacity to provide the inputs that PMPRB is seeking. However, we do believe that there's an opportunity to engage patient organizations on the outputs of the outcomes that the PMPRB deems to achieve with these new guidelines. We recommend that the following steps be taken by the PMPRB in this iteration of the guideline developed and consultation process. These recommendations will support an oral better consultation process and which we hope will lead to a better set of guidelines in the end. As part of the process, so firstly, as part of the process in drafting new guidelines, the PMPRB must provide information that is appropriate and meaningful to patient organizations. Specifically we want to learn about the outcomes that the PMPRB, tends to achieve, both in plain language and in accessible formats. The PMPRB must undertake an impact assessment of the draft guidelines and publicly release that impact statement. The PMPRB must be paid to meet patient organizations where we are at. We respectfully seek an opportunity to review and provide meaningful feedback to the PMPRB on both the guideline objectives and the impact assessment that would be conducted. And we want to do this and consult with the PMPRB this way to ensure that the guidelines, are mutually beneficial, to patients and payers and that the guidelines do not have any unintended impacts that do not meet the delicate balance, between appropriate price and access to innovative therapies. And number four, we believe  patient organizations do have an important, necessary voice and that the PMPRB and other apparatuses of government must do a better job to give patient organizations the space and information, to meaningfully provide feedback on the planned outcomes, and fully recognizing the expertise and the capacities that we do have. In terms of drug pricing, more broadly,  just a few more points here, Canada needs effective and balanced pharmaceutical pricing guidelines, which contribute to sustaining and improving the health and wellbeing of current and future patients. And we believe these guidelines must achieve, a-improve the affordability of medicines for individual patients, healthcare systems and public and private payers, patients, their families and public and private payers, very significant burden of prescription medicine costs. We support efforts to address this, particularly in relation to the international partners. B-ensure timely access to new medicines that address unmet needs, it must be confidence, based on best available evidence, that regulatory frameworks and the guidelines that support them will facilitate and not discourage or deter a rapid  introduction of a comprehensive range of medicines and vaccines, as well as clinical trials which will provide willing patients early access to developing therapies. And then finally, we believe any adopted guidelines should also seek to improve the board's transparency and embed greater accountability through rigorous monitoring and evaluation conducted independently. This will ensure the objectives of the guidelines are met and that there are no unintended consequences to patients access to medicines. Thank you for the opportunity to participate in today's consultation, and we look forward to working with the PMPRB to develop approach that meaningfully and appropriately engages patient organizations.

Peter Morland Giraldo [02:46:49] so and thank you for your advocacy on behalf of your organization. Cystic fibrosis is a terrible disease, and we  are grateful for people like yourselves and your organization for coming forward to us. And I want to thank you for that and, for your work on with Best Medicines Coalition as well. You know, we take very seriously what you say about your past interactions with this board, and we're very, aware of that, that there have been missteps in the past. And  we are obliged to recognize where people's funding comes from in their presentations, as we do with all of our, stakeholders here. But we don't need to prioritize that as an we, we're going to take the content of what you say as the most important thing, and we hope we won't be, putting undue emphasis on other, funding issues in the future. So thank you for being here. With all respect to cystic fibrosis patients and families and, people living with us who, we greatly respect their struggles. And we're delighted that Trikafta is here now. There's a lot of medicines which could potentially come in this category,  the next 30, 50 years, the whole industry, global pharma industry is aiming at a lot of these new drugs, for rare diseases. And we did provide this box five is in our scoping paper here where currently in Canada 57% of the drug sales, pharmaceutical sales are high cost drugs going to less than 1% of the population. So, in your view, can you help us understand that less than 1% of the population, it's an enormous expense. But in in your view, you feel it's worth it and meaningful to these families and these people?

Kim Steele [02:49:01] When I go off of a lung transplant list, we go back to work and you say to. I don't know what those other drugs do, but I do know that, you know, the rare disease population comes with all kinds of challenges when it comes to evidence, when it comes to trials, and they are generally these people don't get access to those kind of trials because they don't exist. So I think what's important is, what does the drug deliver, how is it helping people, what's its impact? And so for me, it's not how much it's being spent on 1%, it's, is  that money that's spent achieving better health outcomes?

Peter Morland Giraldo [02:49:42] Thank you. Comments on that? Let me ask you another question. So it is, the question you mentioned, the question of evidence, the quality of evidence. So a lot of drugs coming forward for rare diseases. You know, they're fairly small patient trials and, you know, some the drug didn't work so well in some of those people, but some of the people did show benefit. I mean, we have a lot of ambiguity, and the evidence and our board, we're asked to and always has to determine is the price excessive of that drug? Would you be favorable if we were to give an initial, you know, confirmation, that an initial review that seems acceptable, but then return a few years later, and review the any new evidence in the  intervening period and kind of do a redetermination, down the road.

Kim Steele [02:50:35] So this is a pay for performance type model, let's say.  I will speak, specifically, on behalf of Cystic Fibrosis Canada, because we represent a number of organizations and best medicines. We are encountering that, right. It was designed for 90% of the population, and now we're finding out all of these people with rare mutations, some of them, maybe 1 or 2 people in Canada, can benefit, too, and it's a different type of evidence, it's in vitro laboratory evidence. And France, which is using a model just like you said,  the US, England, they've all adopted and expanded access using those types of evidence, so I think we really need to look at the evidence, how we capture it, and the story that it tells. But, you know, I can say honestly, as a clinician, I would keep a person on a medication that is working. Now, I can't speak to other patient groups, in terms of prescribing but there has to be value there, and there has to be an impact.

Phil Azzie [02:51:47] Thank you very much. So our next presenter then I'm assuming is Leslie Gaudette.  Leslie Gaudette, president, Council of Senior Citizens Organizations of BC. Welcome, the floor is yours.

Leslie Gaudette [02:52:14] Okay, Am I here?

Phil Azzie [02:52:17] You are.

Leslie Gaudette [02:52:17] Okay. On behalf of Cosco, affectionately known as Costco without the T, I welcome this opportunity to provide input as part of the consultations process. As the largest umbrella organization for seniors in B.C., Cosco was established in 1950 and now represents the interests of 75 affiliated organizations with a combined membership of more than 80,000 seniors located throughout the province. We are a nonprofit, nonpartizan, independent, volunteer driven society that aims to advance the social and physical welfare of British Columbia's seniors through submitting proposals and resolutions such as this one. Since 2016, I've also served as a Cosco rep on the Public Awareness Committee of the Canadian Medication Appropriateness and e-Prescribing Network, known as CADEN, but I'm speaking on behalf of Cosco today. Considering conflict of interest, Cosco is an independent voice for seniors, which relies primarily on membership dues, donations, and periodic government funding, and which does not accept any monies from For-Profit entities, including pharma companies. For myself, my career was focused on the epidemiology of chronic disease control, primarily cancer. Over a span of 40 years, I became familiar with the complexities of Canada's drug approval process, its impact on patients, and the influence of pharmaceutical companies, and this was accrued while working at Statistics Canada, Health Canada, and the Public Health Agency of Canada. My lived experience includes dealing on three separate occasions with close and family members whose health was adversely affected due to taking too many prescription medicines. Again in 1996, I was prescribed a medication which was taken off the market due to severe adverse effects, including death. Finally, when my husband was being treated for multiple myeloma in 2003 with an off label use of the very low cost drug thalidomide, I was shocked to learn that the pharmaceutical company was contemplating charging around $30,000 for this treatment, because that was the cost of similar therapies for [02:54:37] MM, or multiple myeloma, then available. Cosco has previously made submissions to the PMPRB consultation process for new guidelines in 2020 and 2021. We strongly supported these changes as a much needed step to implement national pharmacare, which aims to save Canadians and estimated 6 billion or more per year. And interestingly, as I listened to some of the other presentations this morning, I think it would  simplify the drug landscape within Canada. Cosco supports that pricing decisions would consider both the effectiveness as well as the cost of drugs, and that impacts on quality of life would be included in the assessment process. We were and are keen to ensure that seniors are receiving appropriate, effective and cost effective drugs that enhance our overall health and wellbeing. Today, I would like to commend the staff of the PMPRB  for their ongoing tenacity and professionalism in continuing with what I see as an excessively long journey that you've had to endure to implement the revised guidelines and which, despite your best efforts, have been considerably watered down due to what we are, is reported as daily lobbying, relentless lobbying by well-funded pharma corporations. I'm going to speak at this time mostly to theme 6, [02:56:03] but I will submit a written submission addressing some of the other themes. Cosco's motto is plan with seniors, not for them, thus, we support, that patients, including older adults, be included in consultations by the PMPRB and other stakeholders. These patients, as noted by others, must be chosen with full disclosure of any conflicts of interest and must be independent of any influence from pharma companies. Cosco reps have had opportunities to observe firsthand in public fora the tax cuts used by pharma corporations to derail discussion through patient advocate groups, they are funded and coached. From my observations, pharma companies have built upon the tactics used by tobacco manufacturers to oppose smoking bans in their quest to maximize profits for shareholders. We've also witnessed dismissal of my remarks by pharma company representatives about the PMPRB and its staff at hearings of the House of Commons Standing Committee on Health. This does not give us confidence in the ability of industry sponsored groups to support measures important to ensuring the overall health and economic well-being of Canadians. I'll speak to question 6.3  regarding new high priced drugs, approval and price settings for these drugs should require a very high quality of scientific evidence. Valid and clinically significant outcome measures should be used when evaluating results of clinical trials. Assessments should consider the value added over best available treatments, including not just other drugs, but also through other non-pharmaceutical approaches. Pharmaceutical approaches that treat the underlying cause of the condition and not just the symptoms, should also be considered. Question 6.4 is how can the PMPRB  better engage with you? First, we urge the PMPRB to convene more groups along the lines of this one, but which would aim to listen to the voices of seniors and retired organizations, along with other marginalized groups, and that these groups be independent of the influence of pharma companies, these organizations, often nonprofit organizations, understand the desperation facing low income seniors and others across this country, and especially the 1 in 4 seniors reporting not having prescription drug coverage. For older adults, face to face contact and ability to share information and safe places in public forum are important and much more valuable than engaging on social media. And for the record, Twitter is not necessarily very helpful to many of us. We further urge the PMPRB to consider the impacts of their policies and programs on the lives of real people in the Canadian population. And if you can't do it, somebody can. Here are some key ways the high cost of drugs affects seniors. First, Cosco understands that to improve the overall health of Canadians, our civil society must focus on the attention on the needs of those facing a perfect storm of low income, poor health, food insecurity, housing insecurity, and social isolation. We know that about 5000 seniors in B.C. alone, and that's 10% of all British Columbians, have annual tax incomes of $31,000 or less per year, with about 250,000 seniors living on about $22,000 annually or less. Single renters are most at risk, these seniors often live with multiple chronic conditions requiring multiple medications, yet many must choose between paying their rent or Cutting back on their prescriptions. When a group of low income seniors in my hometown of Langley was asked what they would spend their money on if they had $300 extra per month to spend, seven in ten would buy better food, and 4 in 10 would spend it on health care items, to pay their rent on time. And this is in a social housing complex with some subsidized rents. 3 in 10 reported cutting back on filling prescriptions. The depth of poverty was almost overwhelming and was such that some did not have enough money to pay for incontinence supplies, and others reported not being able to buy a birthday card to mail to a grandchild. Second, seniors are major consumers of prescription drugs. [03:00:49][inaudible] [0.0s] has reported that seniors aged 65 and over accounted for 40% of all spending on prescription drugs and 55% of public drug spending. Kaia further reported  in 2021 that 1 in 4 Canadian seniors was prescribed ten or more drug classes, ranging from almost 1 in 5 at ages 65 to 74, up to more than 1 in 3 for those aged 85 plus. Use of multiple drugs leads to a higher risk of emergency department visits and hospitalizations due to adverse drug effects. These data show the adverse impacts of polypharmacy on the ability of our already strained health system to meet the demands of the population at large, as well as the adverse impacts on seniors themselves. Third, and finally, the sustainability of extended health benefit plans to meet the needs of those seniors and retirees fortunate enough to have access to one is also at risk. The plan I belong to cost me close to $1,000 per year. There are additional deductibles, co-pays and benefits ceilings, which mean that even after any refunds I may receive, I'm still paying for health care costs above and beyond that amount. Of concern is that as costs for extended health benefits rise, the total cost to the insurance companies also balloon. And this is primarily due to the cost of pharmaceuticals. This results in higher premiums, which can price some lower income seniors out of the program. A stark warning was given in the report from the House of Commons Standing Committee on Health that employers were finding it difficult to maintain such programs that the excessively high cost of drugs is straining our health care system. I'll just speak briefly to a couple of other questions, including question 1.4. Thinking of the impact of high cost of drugs to Canadians to seniors, priorities should be given to those drugs which account for the greatest total excessive cost. Regarding question 1.2, we reiterate the critical importance of conducting formal economic assessments by independent agencies, and we applaud the excellent work by the BC Therapeutics Initiative, which directly contributes to the province of BC, enjoying some of the lowest drug prices across Canada and in terms of price reviews during the product life cycle, I will just add that reviews should be triggered as new research results demonstrating changes in effective use of a given patented medicine as after it is introduced to the market are published. We need to consider that the effectiveness of a medication may be lower under actual conditions than the population at large, compared to the controlled environment of a clinical trial. This is especially important for older adults, as clinical trials are often conducted on younger persons who may have no other chronic conditions. These results may not be valid on an 80 year old person who is taking ten or more drugs to treat multiple chronic conditions. Under these conditions, the effectiveness of the drug may be reduced to the point where the new drug is less cost effective than an existing medication. In closing, thank you for the opportunity to express these views on this important public policy debate. We look forward to seeing positive steps being taken by the PMPRB to rein in drug prices for the benefit of all Canadians, and or the cohesiveness of our society as a whole. Thank you.

Phil Azzie [03:04:42] Thank you.

Peter Morland Giraldo [03:04:43] So thank you so much. What an interesting presentation, well researched and a lot of depth of information there. Thank you for, bringing forward the concerns of seniors in such a relatable format. And, so, some of us are rapidly approaching, application status of Cosco, I'm very encouraged to see how forward you are thinking about all of this. So, I have one question I'd like to ask, which is, just at the very end there. You suggested that new medicines, that a review should be triggered as new evidence comes available, particularly in the category of seniors who are having, typically polypharmacy and what is the current trend? The over medicated. There's a lot of, disagreement over overprescription that, many physicians are trying to work against that now and provide guidance on that. So, you think for seniors  it would be helpful if it could be reassessed after a sufficient senior population has been studied?

Leslie Gaudette [03:06:02] Well, like I learned during my career that the drugs are introduced to the market after the four clinical trials are completed and all the steps are taken as outlined by other presenters today. But what can happen is after a year or two, when the drug is in the population at large, it's not under the same carefully controlled conditions of the clinical trial, and therefore its effectiveness may be much different in the population at large. The drugs are often tested on middle aged or younger populations than 65, for example, and then if they're applied to an 80 year old with multiple chronic conditions, who's taking ten or more drugs, as is quite common. The drug may not have the same effectiveness as was seen in the clinical trial results. And so that's what I was the point I was trying to make, is that clear?

Peter Morland Giraldo [03:06:59] It is, thank you. And I just want to observe. You did say that meeting with seniors, face to face meetings would be somehow more meaningful than, some of us who are internet savvy. And I just want to make sure his staff's recording that. And I know you're aware that, but it really does make a difference, doesn't it?

Leslie Gaudette [03:07:16] Yeah. And I think we are getting more like we run all our meetings. We run hybrid meetings, so I'm quite used to that. But, yeah, I think it's just making sure we're part of the conversation, as has been pointed out by some of the other groups and that the independence is really important, and I do respect that,  the comments made by others. But at the same time, I think there needs to be a respect shown. Thank you. Thank you so.

Phil Azzie [03:07:52] Thank you so much. Okay.

Leslie Gaudette [03:07:55]  You're very welcome.

Phil Azzie [03:07:59] Our next presentation is also online. It's going to be delivered by Paul Grootendorst associate Professor, in University of Toronto, and so as soon as you're up on screen, professor, the floor will be yours.

Paul Grootendorst [03:08:16] My mic was muted. I felt like I was in a bubble, I couldn't speak but now that's been resolved.

Phil Azzie [03:08:27] The floor is yours, professor.

Paul Grootendorst [03:08:29] How's the snow in Ottawa? I heard you got a bit of a dusting.

Phil Azzie [03:08:33] Still a little bit in December.  You're ready to go, professor?

Paul Grootendorst [03:08:45] Yes, I am just going to  pop up my screen if I can. Sorry, I didn't have a chance to rehearse the security... Sorry for one second, I have to give security to. Okay. I apologize for the delay. Can you see my screen?

Phil Azzie [03:09:23] Yes we can.

Paul Grootendorst [03:09:25] Thank god. Okay. So sorry for the delays. I'm Paul Grootendorst. Thank you for the introduction. And I'm the economist at the U of T. First of all, thanks to PMPRB for all the great work over the years, all the amazing reports, the informative data. It's going to advance. Question 1.2. Here's the question. Should the new guidelines continue to categorize medicines by the therapeutic class comparator characteristics such as level of therapeutic improvement? Answer, in general, what I think we should do is reward drugs that bring more health gains with higher ceiling. Not excessive price thresholds as indicated in this graph. So that requires that we do assess health gains. We want to incentivize drug development, and pay for drug development that produces, results. And to do so one way is to structure the price threshold ladder, if you will, such that the price ceiling if for drugs that deliver large health gains might be at the higher of the domestic therapeutic class, the highest price in that class and the median international price. So use the higher of the internal reference price and the external reference price. For drugs that deliver a medium health gains, you use the midpoint, perhaps of the internal reference price and the external reference price. And then for the price, for drugs that deliver smaller health gains might be lower of the internal reference price than the external reference price. I noticed that sometimes the median international prices is actually below the domestic price. So you want to make sure that you reward innovators with the higher of the internal and the external reference price. Question 1.5, how should the PMPRB be conducted in initial review and monitor the prices of patented medicines that have few or no international prices? Well, it's a tough job. The only thing I  could think of would be to consult with your colleagues and kind of have them assess the health gains of new medicines relative to the standard of care, whatever that standard of care is. Maybe it's a non pharmaceutical intervention and then compare the additional cost of the new medicine. That's being requested by the sponsors, by the patentee, compare that with the cost of the standard of care, and then see if the additional cost for quality gain exceeds a very generous threshold, of price per quality, perhaps based on the most generous of Canada's peers. That would be to most people's mind, a pretty high bar, for excessive pricing if it exceeds that willingness to pay threshold. Okay. Next question. What approach should the board take with respect to existing medicines, with price prices above the highest international price of the PMPRB  D11? Should the board review these prices and if so, how soon? Answer. Yes. PMPRB should review these prices at its convenience and then prioritize the reviews based on the estimated savings, savings are the difference in the Canadian price per unit in the highest international price times the number of units sold in Canada. Question 3.1 how often should price reviews be conducted? Should they be different for small molecules versus biologics? I wouldn't worry about the small molecules, as much. I would focus on the biologics, the last annual report I demonstrated for the PMPRB review demonstrated that there are biologics for a large and growing share of patented drug spanning with relatively long market exclusivity. And Willie Sutton's law suggests that, you know, reviewing periodically, perhaps every three years as new evidence on drug effectiveness emerges and as the MIP, the median international price declines, that would be helpful. We would expect the MIP to decline because [03:14:21] patentees will typically launch their products in the low price PMPRB 11 countries like Holland in Australia, whose prices are markedly lower than Canada's prices they'll be launching later in those countries. So as those products are launched, they'll be eligible for. The prices of those products will be eligible for inclusion in the median.  What efficiencies could be gained by coordinating decisions and timelines of the PMPRB with those of CADTH, INESSS, pCPA or insurers, public and private. Well, this actually is a major opportunity for efficiencies here. The PMPRB doesn't really affect prices that public payers pay, do they? I mean, public payers being drug plans with hospitals, they already negotiate, don't they? Prices for patented drugs with manufacturers. And these prices are I’d imagine, in almost all cases less than the list price, the price of the PMPRB regulates. Private insurers are going in this direction, but insurers don't seem to give private plan sponsors, particularly large discounts. So the net effect is that PMPRB just helps private plans plus the uninsured. So [03:16:03] patentees who commit to selling exclusively to public payers should be exempted from PMPRB oversight. Although monitoring and reporting on prices seems to be warranted. So that would make a the PMPRB's job a lot easier, you would not, under this proposal, have to regulate prices that are of medicines that are sold exclusively to hospitals and public drug plans. I guess a side or a follow up point is that if we do go, towards the National Comprehensive Pharmacare Plan, then the PMPRB  price regulatory role would be greatly reduced. We wouldn't need price regulation because all  the prices of new medicines would be subject to, negotiation, not regulation. Now, of course, it would still be helpful for the PMPRB to report on prices and R&D spending. And that concludes my presentation.

Vice Chair Thomas [03:17:17] Oh. Thank you. I appreciated the question and answer.

Peter Morland Giraldo [03:17:22] Thank you so much, professor.  So many interesting thoughts there. And you did follow the instructions quite carefully there, going through the questions,  as vice chair says, so many interesting answers there. So you're interested in the therapeutic level, maintaining the therapeutic level as a basis of evaluation because we should incentivize health gain. I like that. That seems to make quite inherent sense and probably makes sense to everyone in the room. Not everyone in the room, but some people think that that makes sense. So health gains. Sometimes it's hard to measure early on when a new drug comes to us. It's hard to measure the health gains. Do you feel then this would align with your reference to the Willie Sutton law, which would get us to review after about three years. We could actually measure those health gains. Would that sound like a reasonable path?

Paul Grootendorst [03:18:29] Every year you'd imagine that there would be more evidence accumulating in respect of how well that drug works, based perhaps on observational data, maybe phase four trial data. Safety signals, that kind of thing, especially if the drug is launched, outside of Canada, maybe in the US first. That's, a large number of people for whom there will be some evidence perhaps on effectiveness and safety.

Peter Morland Giraldo [03:19:08] Yeah. Okay. Your, comment on question 5.1 that, maybe a public payer or doesn’t need to have a list price set for it because it's going to negotiate a rebated price, which is generally lower than the list price. But that would leave private insurers, a bit at a loss because they also negotiate prices with the manufacturer of the drug. So I think our mandate, our federal mandate is to measure these list prices against our three criteria. So we wouldn't want to leave the private insurers, out in the dark there.

Paul Grootendorst [03:19:53] No, that's why I suggested that if a drug is intended for reimbursement by a private insurer or out of pocket, then it certainly be kept under the PMPRB purview.

Peter Morland Giraldo [03:20:07] Yeah. Usually there's a is considerable crossover between the two, but sometimes they can be distinct. So all right.

Vice Chair Thomas [03:20:13] So I guess it's not because it’s public payers buying that private are not interested, right?

Paul Grootendorst [03:20:22] Yeah I'm not sure. Maybe it's the case is that all drugs are eligible for reimbursement by both public and private. But you can imagine I was thinking that some drugs would be administered solely in hospital settings. And if that's the case, then it's it seems to me that that would be, public reimbursement, but I could be incorrect on that one.

Vice Chair Thomas [03:20:43] I'm going to ask if there's an example of that. Is there an example of that, of medicines that are solely sold by only by hospitals or administered by hospital?

Koebernick [03:20:52] What about heroin?

Vice Chair Thomas [03:20:55] Oh, yeah. Yeah. That is one, I think. But I don't know. I don't know how much of it's used anymore here. Maybe it's used more. Interesting.

Koebernick [03:21:08] Hey, just a clarification question, to help me with health gains. And so what is your definition of it?

Paul Grootendorst [03:21:17] Of a health gain?

Koebernick [03:21:22] I just want to have a sense of what your definition would be.

Paul Grootendorst [03:21:26] I like a gain that measures both length and quality of life improvements. So I'm kind of partial to the quality measure, the quality adjusted life year. Although, I've seen other ones too that seem okay.

Koebernick [03:21:42] And, go ahead.

Paul Grootendorst [03:21:46] There's also the healthy years equivalence measure, proposed by Miriam Gaffney at McMaster University. But anything that sort of measures holistically the value to the patient in terms of the impact on both how long they live and the functional capacity in their health domains, like their ability to walk or their ability to be free of pain or their ability to you know, to use their arms or to see, those kind of things, you know, patient-relevant domains of health, health and quality of life, I mean, to say. And, you know, it that measures both the quality and length of life, I think would be important.

Koebernick [03:22:34]  I think this is where you would say CADTH would be instrumental in determining and measuring health gain?

Paul Grootendorst [03:22:41] Well, they would.

Koebernick [03:22:42] How could we get that information?

Paul Grootendorst [03:22:45] I'm not sure if they have the capacity to conduct original research. But they certainly have the capacity to summarize evidence that's already been collected. They do literature review all the time; I think.

Koebernick [03:22:59] They might have a definition already, who knows.

Peter Morland Giraldo [03:23:03] Sorry, I was just going to ask one more question. I think we're almost out of time here, but I just because you raised the question of, reviewing the HIP drugs that are existing medicine list of the existing medicines that are above the HIP, you suggested we should do it immediately. I didn't think I'd get the chance to ask this question, but I will. Isn't there some way that perhaps someone with an existing approved price that's been reviewed and it happens to be above the HIP, that there's some reasonable business sense that maybe we should allow that to continue because perhaps the company's already committed to that price. And now we went and changed the benchmark. I mean, you think that price should still be?

Paul Grootendorst [03:23:52] Actually, I'm not. I don't have a firm opinion on that, I don't have a firm opinion. I thought this was kind of more of a legislative requirement, but this is more discretionary. I can see some grandfathering, only because people have made plans based on the price that was awarded or allowed earlier, but because you had a deal going so to speak.

Peter Morland Giraldo [03:24:22] Well thank you.

Paul Grootendorst [03:24:23] I guess you could live up to that and that might be grounds for continuing that price. Although, you know, you can imagine that if it's a two standard deviations above the line, well above the highest international price, that's another that may be grounds for some compromise on by the manufacturer.

Peter Morland Giraldo [03:24:43] Thank you for these thoughts. I think the word discretionary and grandfathering fit together quite nicely in your answer there. Thank you for that.

Paul Grootendorst [03:24:54] Pleasure.

Phil Azzie [03:24:54] Thank you very much, professor. Our next presentation is also going to be delivered virtually. Jason Field, president and CEO, Life Sciences Ontario. Good afternoon everyone.

Jason Field [03:25:32] Can you see me and hear me?

Phil Azzie [03:25:34] We can hear, and there you are.  And the floor is yours.

Jason Field [03:25:38] All right, well, I'm going to try sharing my screen here, but teams hates me, so I'm going to tell you to wait  for one moment, I'm going to see if I can. Can you see that presentation?

Phil Azzie [03:26:03] Yes we can.

Jason Field [03:26:05] And is it moving back and forth?

Phil Azzie [03:26:06] Yes.

Jason Field [03:26:11] All right. I think I'm good to go. First of all, thank you very much for the opportunity to present, today, and I apologize for, not being there in person. I would have very much like to be there, and I'm certain that there was a lot of, very interesting lunchtime, conversation that I missed,  so, I definitely regret not being able to be there. But I do want to start by commending the board, on this new round of consultations. I think that, you know, in previous, consultations ourselves and many other stakeholders felt that our concerns weren't really, heard. And that the consultations were perfunctory versus meaningful. There certainly was a new tone, I would say, to the scoping paper. And I'm optimistic that these consultations will be meaningful and the board will continue to engage stakeholders, in an ongoing basis. And I think we heard a few comments about that, earlier. So I'm here representing the members of Life Science Ontario. We are a fully member funded, not for profit organization dedicated to championing Ontario's diverse life sciences sector. Our focus is advocating for public policies that support the growth and advancement of the sector. And we do this, by collaborating and aligning with other life sciences stakeholders. And we always do it from the perspective of a science first and evidence based position. The reason for that is that I'm actually a scientist by training. I previously conducted research that has resulted in patented innovations, in particular in scale up processes for making active pharmaceutical ingredients. In short, I've made drugs, and I know what it takes to do so. What really differentiates LSO and my apologies for the eye test error, for most of their organization is the diversity of our membership. Unlike most industry organizations, we don't actually just represent industry. We represent the entire life sciences community in Ontario, and that includes academic institutions like colleges and universities, service providers, as well as companies big and small. And it's because of this diverse representation that we first became involved, with the changes in PMPRB. And it was actually this statement that was first, published in the Gazette back in 2017 that really inspired me to take action and  I want to recognize that there's been significant changes over the last seven years, to the board, but it was this statement at this time, that demonstrated to me that the PMPRB at the time, really didn't understand, the dynamics and connectivity of the Canadian life sciences sector. It demonstrated a lack of understanding of the high quality jobs. The investments in research and research chairs, clinical trials, investments and patient support programs and investments in Canadian commercial and in the commercialization of Canadian technologies. And most importantly, the impacts to the lives of Canadian patients. So in considering how to address this lack of understanding, we set out to collect evidence of the impacts of these proposed changes. And we started by surveying 46 life sciences executives, from Canadian affiliates and global companies, as well as companies large and small, and this is what we found, 90% of the respondents indicated the proposed changes, would have negative impacts to their business and specifically product launches, innovation, investments, employment and clinical trials. And this, of course, was in stark contrast to what we read, published by the PMPRB in  the Gazette. So the next thing we did was partner with IQVIA, to publish this report that was looking at the trends of new medicine, launches globally. And, you know, these are what we focused in on here,  in this series of reports with IQVIA is innovative new therapies. So these are not me-too drugs, they're not reformulations, and very importantly, they're not just Health Canada approved. These have to be, products that are sold in two or more jurisdictions. And so they're actually accessible to patients. What we found was that more than half the new drugs launched globally in 2018, were still not available in Canada at the time of the launch of this report. Most of these were in areas of ecology and rare disease, and more disturbing at that time was the divergence that we were actually observing, from the global trend, which showed more innovative new drugs coming to the global market, but less of them, actually, arriving here in Canada. In 2022, we engaged IQVIA again to update this data to see if this was just an anomaly. And first, when we looked at Canada over the past two decades, we actually saw that Canada has fared quite well in terms of time to launch of new medicines. We still lagged, some jurisdictions like Germany in the UK, both in terms of time to market and number of new medicines that that come here. But, you know, it was really interesting to look at the data of China, for example. It's the second largest global market, but it's also somewhat an uncertain and unpredictable regime. And so I think it's an interesting, to note this, that there's an importance in terms of having a robust and predictable regulatory environment. Published elsewhere, IQVIA has continued to look at this data, and we've seen the trend of lowered launches in Canada continue. And most recently, just nine medicines have been launched, at the end of August of this year, which is around half of what, should have been, expected. So again, launches are different from  just Health Canada approval. But looking again at the at the time to launch data, Canada has done well over the last two decades. We ranked fourth, with the median time to launch of 1.2 years. However, when we look at the latest data that was available, at the time of this report, which was, for 2021, we saw a significant increase in the time to launch to 2.1 years, which would put us at a rank of ninth, globally in terms of time to launch. So we need to keep an eye on this metric. It's a key success factor for several government, initiatives, including the biomanufacturing, the life sciences strategy, the rare disease drug strategy. You know, and as we think about regulations that impact access to medicines which is one of the reasons why we're all here today. So finally, I'd like to close by kind of sharing my thoughts, around what the key learnings have been over the past seven years of engaging with PMPRB and advocating for policies in support of the entire life sciences sector. First and foremost, we need to recognize that life sciences is an ecosystem. You heard my colleague Andrew Casey from Biotech Canada earlier, giving the analogy of the coral reef, I couldn't agree more,  any natural ecosystem, you cannot impact one part of it in isolation and not expect the rest of the system to be unaffected. So, there will be impacts. And these guidelines will have implications beyond the pharmaceutical industry. They will impact our own Canadian life sciences, ecosystems as well as Canadian patients. Secondly, the uncertainty that has come with the turmoil surrounding these regulated regulatory changes over the past several years has delayed access to new medicines and the data that I presented, certainly support that. They've deterred investments and inhibited both innovation and economic development. Now, it's hard to quantify the absence of something like investments. But we know with a fair degree of certainty from the interactions that we've had with our members that we have lost opportunities due to this ongoing uncertainty. The best approach for PMPRB with these current guidelines is to adhere to its clear mandate of ensuring that pricing is not excessive. And again, we've  heard that theme throughout the day. We don't think that PMPRB should venture into other areas that are covered by other regulatory bodies. And again we've heard this throughout the day. So, getting into the purview of price setting which you know is pCPA or therapeutic referencing, which is the purview of agencies like INESSS. Third, the world has changed since these regulatory changes were first introduced in 2017, not the least of which is we lived through the worst pandemic in a century. When we were struck by this crisis, we found that Canada's capacity in biomanufacturing and life sciences was wanting, in large part because this sector was neglected, there was no industrial strategy for decades, there was no shared vision, and I would argue that there was, you know, fairly contentious relationship, between industry and the federal government in large part, I think, because of the ongoing situation with PMPRB. But now we have, the biomanufacturing and life sciences strategy, and we need to align with the goals and vision set out there. Five out of ten provinces, including Ontario, also have life sciences strategies. And in terms of these relationships between public and private sectors, we really have learned that they are critically important. And when we think about through pandemic preparedness, we must ensure that we have an ongoing and strong collaboration between industry and government at all times, not just during crisis. Lastly, we need to build in flexibility and nimbleness into our regulations. So we want predictability and certainty, but we don't want to also, you know, be so rigid that we can't adapt and respond to changing environments. Covid 19 was a great example of this where we had to actually circumvent PMPRB to enable access to vaccines and treatment. And, you know, as we think ahead, Canada is currently struggling, in terms of access to new antibiotics, for example, even under the old rules. Over the previous decade, just two out of 18 novel antibiotics were made available in Canada. So we may need to consider strategic investments to address things like antimicrobial resistance. I'd like to express my gratitude, to the job board and the staff for the opportunity to provide those perspectives as you develop these guidelines. We will be, of course, submitting a written submission with more details. The life sciences sector, in my opinion is Canada's greatest untapped potential,  but we must acknowledge that it is a very complex sector. And there's an intricate web of challenges as well as opportunities and it demands a comprehensive approach. We have continued to stress that the all-government approach, which was, described in the Biomanufacturing and Life sciences strategy, is the correct one. PMPRB has a role to play there, and ongoing engagement with stakeholders is a necessary step in creating a viable life sciences sector in Canada and ensuring that Canadians have access to new medicines in a timely manner. So we would support, I think, several presenters today have recommended working groups, technical working groups, continued stakeholder engagement. And we would certainly, emphasize that as well. So thank you very much for your time today.

Marie Perrot Thomas [03:38:25] Thank you, Jason.  There's a slide there in your presentation that I've seen about the two years and a half different sort of time it takes to launch a longer time. I'd like, because we know it's a complex ecosystem in Canada because of the federal provincial jurisdiction and all that and I'd like you to explain in a little bit more why you're making a link between that time and solely the PMPRB or maybe you're not. Maybe it's not solely the PMPRB, but I'd like to hear you about that first, and second, how can the guidelines that we will be writing soon? Well, how do you see we could prevent that if you're making a link, what do you think we should do with the guidelines to prevent that?

Jason Field [03:39:26] Well thank you. Thanks for the thanks for the question. I  wouldn't say that PMPRB in isolation, because it doesn't operate in isolation, I mean, the pathway, from, Health Canada approval to a patient is a long and winding road and goes through several layers of government. It goes through health technology assessment, it, goes through, pCPA negotiations, it goes through, provincial formularies, you know, it's it is a long and winding road. So, I'm not suggesting that PMPRB in isolation, is responsible for delays but it has a role to play. And I would say that particularly over the last several years, where there was that environment of uncertainty, we have heard directly from our members that it's difficult to plan, and there has been delayed and launches and we've seen that through a variety of anonymous surveys like the research, etc., data that I've, shared with you. So certainly I would say that again, that, that reflects the role that PMPRB has played in that trend that, that we're seeing in terms of increased time to launch. Now, to answer the second part of your question, what can PMPRB do in the current guidelines? It's really bringing clarity and certainty and predictability. And we've heard all of those words, over the course of today. And I think in doing so, it's something else we've heard today which is sticking to the mandate, which is excessive pricing and being very clearly focused  on that aspect of it. Leave the price negotiations to pCPA, leave the FDA's assessments to the INESs and worry about setting the ceilings and the and the other organizations will, you know, take care of their mandates.

Marie Perrot Thomas [03:41:30] And about that. Where do we draw the line? The guidelines are to help us to  manage this,  we don't want to see all medicines coming through and going to a review, right? So we need to decide if we are going to review or not and decide  if the prices deem excessive or not. Where do we draw the line. Where would you draw the line?

Jason Field [03:41:56] Well, I mean given the guidelines and we will submit a written, description of this as well. But given the scoping paper, and the two choices presented, which was  the MIP and the HIP, we would we definitely say the HIP better aligns with the mandate of the PMPRB in terms of looking at, excessive pricing as has already been presented, the change in the basket of countries has reduced, net list prices, already by about 20%. So if the mandate is around excessive pricing, and we've determined that these are the basket of countries that we're going to be comparing to, then we should be looking at prices in excess of those. So HIP for me makes sense from that, particular perspective.

Peter Morland Giraldo [03:42:54] I just had one quick, very quick. Thank you, for your suggestion about working groups. And I've often wondered about the reports from [03:43:03]LSO [0.0s] about the decline in innovation entering Canada. We have a slightly different understanding regarding I referred to it earlier today that the Meds Entry Watch Report, specifically, it's figure 8.4. And if you could make any comments about what's the difference between what you're seeing and what we're seeing in Figure 8.4 on your submission, you and anyone else in the room, it would be very helpful for us just, because we are going to continue to work on the Meds Entry Watch Report, and we want to make it better for next year, so we're clear on what we're talking about.

Jason Field [03:43:40] Yeah. Thank you for the question, Mr. Chair. In the terms of the bids entry data that you're citing, I don't know the methodology, I'm assuming, and I don't know for sure, but I know that in other reports that I've read from the PMPRB they've looked at Health Canada approvals as the main metric, the IQVIA data actually looks at very specifically innovative new drugs that are accessible, by patients. That means there's actual sales data, that they look at, and these don't look at any reformulations or me-too drugs as required out of that, I don't know if it's the same in the reporting that that you do. What I can tell you is that, as a scientist, I really made me happy when we first met with IQVIA because they talked about an hour around their methodology with us, first and foremost before anything else, and it was something that we really bought into because we thought it would bring, robust and credible data to this conversation. We feel very comfortable with that methodology that was being used because it looked at, again, very specifically, these are new innovative drugs, not me-too drugs, not reformulations, they're accessible to patients in multiple jurisdictions, so I think you commented previously about situations where you see data of a drug being launched in a home jurisdiction but not another, these are, minimum of two jurisdictions that are looked at. So it's very specific methodology and it's drawn out in their report quite clearly.

Phil Azzie [03:45:18] Thank you very much. We'll now move on to the next presentation. JK Harris, Canadian Breast Cancer Network and we are going to turn off the lights for this presentation. Is that okay?

JK HARRIS [03:45:41] For dramatic effect. Actually, I'm sensitive to lighting, so I appreciate you accommodating. Hey. Good afternoon, my name is Jk Harris. Good afternoon as well to everybody joining online. As mentioned, I'm with the Canadian Breast Cancer Network. I'm the health policy advocacy lead. It looks as though I've inadvertently.  Anyways, it was only four slides, so it's okay. That's mostly what I'm talking about today. So I also want to extend the greetings of our board chair Kathy Amendola, like all of our board members she does have the lived experience of having had a breast cancer diagnosis. She wasn't able to join us today,  she has other obligations, but she did want me to extend her greetings as well. The Canadian Breast Cancer Network was founded in 1994, and it exists to ensure the best quality of life for people in Canada diagnosed with breast cancer, CBCN is Canada's leading patient directed breast cancer health charity that voices the views and concerns of breast cancer patients through the promotion of information sharing, education and advocacy activities. And to say that I'm humbled to be presenting today is an understatement, I'm very grateful to be here. So for today's presentation, and again, I'm having trouble making this advance. Can you just go one slide forward, please?

Phil Azzie [03:47:17] Okay.

JK HARRIS [03:47:19] I'm going to be spending the rest of my presentation discussing this question, which I believe is question 6.4. How can the PMPRB better engage with us? In this case, people living with breast cancer and the Canadian Breast Cancer Network. So, I hope to offer some concrete examples of how that has been done well in the past because as the guidelines are being developed, I hope we can look to previous successes that can be implemented moving forward with these guidelines. So if there's one thing that I hope everybody can take away from my presentation, if there's one thing I want you to know about engaging with people who have breast cancer it's that it's an ongoing process, it's a commitment to building relationships, and it doesn't end, it's something that has to keep going. And so, of course, that basic question how do we build those relationships? How do we keep that dialog ongoing? And I'm going to just give two examples of how this can be done. There's certainly more than two, but I'm going to focus in on two today. And that is dialog and discussion and effective knowledge translation. So, I think it's been mentioned by many of our presenters today that having a forum like this is an amazing first step, you know, I'm literally here able to speak to other stakeholders like you folks in my eyeballs and have questions asked to me as to you, it's a back and forth, this is something that we at CBCN and personally really love to see, and we would like to see more of this. So we saw this same example earlier in the year  from the Canadian Pharmaceutical Alliance, pCPA, when they did their time limited, their temporary access program, they had a very similar format to that consultation where, again, stakeholders, in addition to the written feedback could make a webinar, have a Q&A, hear from the pCPA about what they were planning to do. And they also were able to discuss some of the uncertainties of what they were hoping to get feedback on. So this is a format, this two way exchange of information, really awesome, we'd like to see more of that. I want to emphasize that this is a starting point, the conversations like this, this is where we start and it needs to continue. And so you might be asking yourself, joking, that sounds awesome. We'd like to be able to continue having a dialog with you,  or at least I hope that's what you're asking. But  you might be saying, well, how do we do that? How do we continue to have that dialog? How do we continue to have interactions with different stakeholders? And especially, you might ask,  it's no secret that the guidelines are very technical, very complicated, and it can be challenging to get the input of people who maybe haven't studied this specifically to be able to comment meaningfully, we have very technical questions even around how do we apply section 85 of the patent doc, if you go and ask somebody on the street, they're probably not going to know what you're talking about.

Marie Perrot Thomas [03:50:46] Hopefully they don't know.

JK HARRIS [03:50:50] But I'm just illustrate it does beg the question. I'm saying patients want to be part of the conversation. And if the questions you're asking are very technical like this, it does beg the question, well, how can they comment on these technical questions? Do they even really want to have the ability? Well, I mean, certainly we already had two previous panelists today who self disclose that they've had a little experience with having had breast cancer. So I mentioned we have all of our members of the board that lived experience. We also have a wider network. But this does lead me to my second example of knowledge translation, right? And it's important that we're able to engage with patients in a way that these technical questions, we're learning from patients what their value is on these points, what do they want to see as an outcome, and going from there right? So I'll point to a concrete example of that. And I would, point people to clinical trials Ontario. So this is similar insofar as it's a scientific process, right? Clinical trials are highly scientific, and they have resources surrounding patient and public engagement,  they also have a patient experience toolkit, and this really lays out like they have practical information and practical guides for researchers on how they can ensure that patients can basically understand the results of the clinical trials, how they can engage the public better, how they can engage patients better. Now, if you see things there that you feel resonate with the PMPRB, that's awesome, but I'm just bringing this up to illustrate that it can be done when we're dealing with highly technical content, I'm not suggesting that we superimpose what they've created on us with these guidelines.  And so I'll just bring this up because. I believe, and we've seen today that patients want to be part of the conversation. We're willing to put our hands up and come forward, and we really believe that the value this brings is the results are more robust, right? We're going to achieve a result that ultimately serves patients for whom drugs are created, that reflects what they're looking for and what they value. So I would really encourage, anybody who's listening and of course, for the PMPRB to look at how can we ensure that we're embedding the patient voice along the whole continuum in a way that we can meaningfully engage, even when the topics might be very technical, might require a certain level of expertise but to know that it has been done well in the past, and I certainly believe that it can be done well here. In fact, I look forward to it being done here. So, I'll just summarize,  we would love to see a commitment to that ongoing relationship. We really believe that there's one thing to know about patient engagement it's ongoing and it's about building relationships. And just two ways that this can be done is through, effective knowledge translation and making that commitment to having ongoing dialogs. So I just conclude by inviting you folks here today, anybody who's joining online or perhaps here in the audience today, you're certainly welcome to contact me, my email is jkharris@cbcn,ca and I guess I'll just leave time for questions.

Koebernick [03:54:35] Thank you very much. The only comment I would have and thank you for your presentation is that's let's do a pretend we go forward and have maybe some sort of a working group, what I'm hearing from everybody in this room, by the way. But let's say that we follow the example that we've done in the past, which I'm hearing from many people, it's an effective way to move forward with developing guidelines. So you're looking to be included in that. So either you have, the ability to hear what's going on, you may have something you want to add, but you just want to be a participant in the process of ongoing consultations. I think to be I'm just trying to be more simplistic than anything else.

JK HARRIS [03:55:29] So I'm not personally familiar with what the format of the working groups were previously.

Koebernick [03:55:35] Some highly technical from my understanding. But some not, I think.

JK HARRIS [03:55:37] I think my question would be, did you have patient representatives on those working groups?

Koebernick [03:55:44] Maybe Guillaume, could you answer that? I'm not even sure. I guess, it would have depended on what working group we were talking about, I don't know.

Peter Morland Giraldo [03:55:51] I can add to that, because of which working group, but I know there were some patients before, especially the steering committee and the, technical, working group before, I cannot speak about more than eight years ago, nine years ago, I wasn't here, but.

JK HARRIS [03:56:12] So, I'm not sure what form those took in the past.  But again, too, I mean, there's many pieces to any project, right? So, I mean, I'm not saying don't do working groups. It's just to look at, hey, you know, is this something that we can bring up patient voice in? How can we do that? At CBCN we are certainly willing to work with you. But we also have a wider breast cancer community, that's, again, with the right knowledge translation. I'm sure would be happy to at least offer their input to about what value they're looking for in the work that you're doing. Right.

Koebernick [03:56:46] I think, some of the other organizations are presented here, you want to know what's going on exactly, at least if not sit at the table, have an understanding of ongoing processes, and if you wanted to come, then just say, hey, I have something to say.

JK HARRIS [03:57:02] Okay, thank you.

Marie Perrot Thomas [03:57:03] I think that's why we put a question six, engagement with patient groups and other stakeholders, it reflects the importance that we believe in the conversation with you.

Peter Morland Giraldo [03:57:19]  I think we're all analysts, and our friends and family are all touched by breast cancer. And we all know the relevance of what you're bringing to us, so thank you.

Jason Field [03:57:30] And I look forward to further discussions.

Phil Azzie [03:57:34] Thank you. So we'll have one more presentation and then we will take a short break. I will invite the next presenter then. David Chang, director of strategic access and pricing, Hoffmann-La Roche Limited. The floor is yours.

David Chang [03:58:36] First of all, thank you very much, tech Forward, for having us. We do appreciate that we're the 17th speaker today. I really appreciate your ongoing engagement. So my name is David Chang. I've joined with my lovely colleague Abigail Smith, and we're going to spend the next 10 to 15 minutes talking about, sharing our thoughts and focusing on the first three themes.  Could you just advance the slide for me? So I thought we'd start off with, you know, why are we here today? So our goal is to ensure that many patients have sustainable access today while fostering innovation for tomorrow. And we believe in working collectively to work with patients and the health care system. So just keep it there and carry I'm going to click on the PowerPoint.   Sorry about that.  So just, quickly about our company. So Roche is one of the world's leading pharmaceutical in future diagnostic and diabetes care management companies. We started, the affiliate in Canada in 1931, and today we have 2000 employees. The pharmaceutical headquarters is based in Mississauga and the and the diabetes care diagnostics space in Laval [04:00:53]. [0.0s]

Abigail Smith [04:01:00] Delivering meaningful benefits to patients for a long time. And in 2022, over 290,000 Canadian patients were treated with Roche medicine, 1 in 4 were tested using a Roche diagnostic product, and there were 190 active clinical Roche trials  cutting edge medicines to 1891 total active patients. Globally, we invest more in R&D than any other pharmaceutical biotechnology company, and we're in the top ten of R&D investors across all industries. Roche is responsible for some of the most meaningful breakthroughs in science medicine, with 32 medicines currently on the W.H.O. list of essential medicines. We've included treatments in a range of areas, including in oncology, which include cancer immunotherapy, infectious disease, inflammation, ophthalmology, neuroscience and rare diseases.

David Chang [04:02:01] So before we start,  we like to share our approach on pricing and how we sell products. So we take a value based approach, pricing our medicines that reflect the benefits to patients, to their families, to the health care system and society. And through this, we aim to support access to our medicines for as many patients as possible today, while ensuring that we're able to continue investing into highly complex, risky areas and drug development to bring innovations for the future. And through this we worked closely with payers, governments and others to meet the needs of the health care system.

Abigail Smith [04:02:42] I won't take you through this in full, because other people have made this point today. And I think that there were 17  presentations, but this is just to reinforce that it's part of a broader ecosystem in this discussion. And just in particular with regards to the pCPA and come up in previous presentations, while the rebates are confidential, the pCPA reports annualized savings of $2.67 billion just in respect to brand name drugs. So I think we can take it that they’re fairly substantial. The other point to take away from this slide, which is similar to things that the others have said today, is that PMPRB plays a distinct role in this ecosystem. It is there to protect consumers against the abuse of the patent monopoly, that's a specific role. Excessive pricing due to abuses of the patent monopoly, as most recently articulated by the Federal Court of Appeal. But the PMPRB has to fulfill that role without incentivizing innovation, which is the underlying purpose of the patent regime, or impeding access to medicines, which I think we're all here recognizing as paramount today.

David Chang [04:03:46] And I won't go into detail because I think we've covered this in detail today. But we really think that the principles should be anchored, when creating these guidelines. We've heard this before, it should be predictable, transparent, access  should be focused, efficient and simple. And so how we propose taking those principles, what we're proposing today is similar to, to others, and that the introductory price review should take into account the IRP or the PMPRB  11, that simple threshold should be something along the lines of a HIP and if it's greater than HIP,  and it could be a consideration of other factors, the section 85 factors. But if it's below, we're suggesting that may be considered not excessive at that point. And then in terms of the annual  monitoring as long as the launch price is assessed and not deemed to be excessive and the list price does not increase beyond the allowable CPI increases, it shouldn't be considered excessive as well.

Abigail Smith [04:04:50] In terms of abuse during the product lifecycle because for a couple of reasons not to re-bench, as other staff have stated, and starting with my second point, re-benching  introduces significant unpredictability, it is undesirable for all the reasons that other presenters noted. We also think that  after introduction, the international reference price becomes a bit flawed as a metric due to systems differences. There are there's heterogeneity in markets, develops over time. You also start to see divergences as between Canada and the system partner countries. So while the international reference price provides a good threshold at launch, after that we think it is less useful. In terms of the transition plan we propose to grandfather existing medicines, having them assessed under the guidelines that were in place at the time that they were launched. And for new medicines, we propose a transition period of at least two reporting periods. That's consistent with what PMPRB was proposing in the past and should give Roche the time to make the administrative changes that it needs to make in order to implement a new system.

David Chang [04:06:10] So this is our last slide. So I just wanted to, to just summarize by saying, I think we heard a lot today from all the speakers about the mandate of the PMPRB, the principles and approach to the new guidelines. And I'm optimistic and encouraged that, you know, the dialog is starting, and that we can collaborate with either working groups or some kind of forum to work out the specifics of the guidelines. Thank you.

Abigail Smith [04:06:36] Thank you.

Peter Morland Giraldo [04:06:39] Thank you and executed with brilliant Swiss efficiency. We do hope to bring such a model to the PMPRB. We knew our efforts on that particular line. Excellent scenarios told and explained to us. Go ahead.

Marie Thomas [04:07:10] Just want to come back to grandfathering because it's a bit of a preoccupation, distinct concept that we're all talking about. The scoping paper, for me, it's a question of what authority do we have to grandfather? I'm not saying we don't, maybe we'll find it, maybe we'll just assume. I don't know, but is there something you could help us with to support grandfathering as the appropriate way to move forward?

Marie Thomas [04:07:45] Because if we just grandfather, then some of you may not like it and then, you know,  that's where we end up. So, you know, I'm just trying to figure out, we're trying to figure out ways forward that will be clear, predictable, not create chaos again in the system. So the more we can get from people here, get ideas and suggestions, you understand how it impacts your patients, the more helpful it is. Yes, you don’t have to answer this second, but go ahead and if you can put it in submissions, if you don't want to answer, to the other people around here, it will be helpful.

David Chang [04:08:24] I'll take a stab at it then... I think it's a good question. And we've thought about this as well how to grandfather products. We feel that products, existing products that have fallen under the old guidelines and have been compliant or non excessive under the old guidelines should remain. So to give you an example from our company, so we've done basically agreements with pCPA for almost all our products. So we took a look back at the last 3 or 4 years, including the private market and the public market, and 94% of all our sales are under that agreement. So we have contracts in place already for the vast majority of all our sales. If you look at even how pCPA works, they've got 500 contracts over the last 15 years. Or the last ten years, at least. So, I think those ones that are in place. For that reason, you know, should stay in place.

Marie Thomas [04:09:15] And they're multi-year.

David Chang [04:09:16] And they're multi-year. They tend to be rolling, auto-renew.

Marie Thomas [04:09:22] I suppose…

David Chang [04:09:24] Could I make additional comments on that?

Marie Thomas [04:09:28] And those that aren't part of those listing?

David Chang [04:09:31] I can't talk for the whole industry.

Marie Thomas [04:09:39] So in that sense it sounds you're not saying that, but it's almost a differentiation between those which have already engaged, who are contracted for over a long period of time, and those which just are on the market for a period of time, which might be a differentiation, of course, somebody might say that that's unfair. So okay. Thank you. But again, it's an invitation to all, any suggestions on how to look at medications?

Abigail Smith [04:10:10] Just to just to that and his comments. I think it's more that we just haven't considered it from the alternate perspective. It doesn't apply to us. But even products not subject to PLA would have commercial structures in place. So it would be disruptive for them as well.

Marie Thomas [04:10:25] That would be the argument, exactly.

Abigail Smith [04:10:27] Yeah.

Peter Morland Giraldo [04:10:29] So  you don't support re-benching price after a few years after it's been on the market? But let me ask how that would impact, because if 94% of your products have PLAs in place, if the PMPRB comes along a few years later, it says, yeah, that price is excessive. The list price, which isn't a negotiated price, say the list price should let's say it should come down by, a few percentage. Is that going to impact what happens under your PLAs? Don't give me any trade secrets. But I mean, if the approved list price comes down, would that have an impact on what you're paying under your PLAs?

David Chang [04:11:14] Maybe I'll answer that probably in in a couple different ways. So, theoretically, if there's a difference between the net price and the list price and that the difference is enough, a decrease in list price, theoretically, shouldn't affect the net price because the net price is still there. Where it can affect it is how the structure is calculated. So if the structure is based on a list price calculation, then it will, but if it's so it depends on the structure of it. Also PLAs have multiple different ways of structuring and price rebates is one of them. So there are also multiple different ways that a PLA could be done. And furthermore, as was discussed, by my previous colleagues, it does have an effect on international markets,  other markets that affect us, and there's probably, you know, we mentioned China, but there's also some in South America, Middle East, Asia as well.

Peter Morland Giraldo [04:12:06] And we calculated that to kind of is about and it is reference is about 20% of the world markets and the 80% the biggest markets Canada's  list is not really a factor. Sorry, but I take it the 20% can be significant, right? So many, many billions of dollars right into that. So the PLAs and it depends on the structure of your PLA, doesn't it? That if it's unconnected to the federally, the non excessive federal price, then it won’t have any impact if we re-benched down the road.

David Chang [04:12:30] And not to, not to presuppose that they're all rebates. It's how PLAs are structured; it could be there other kind of other ways that we could do. but other ways to calculate that could be market caps on, on the market, things like that.

Marie Thomas [04:12:57] I'm just wondering how we reconcile that with our mandate to vary along the patent life. The whole life of the patent. Right?

Abigail Smith [04:13:09] I think one way to do it would be through monitoring as previously, the PMPRB has previously exercised a mandate without re-benching. If you can’t do it again, that would be a shame.

Phil Azzie [04:13:25] Thank you. So it is time for the afternoon break, which I am going to shorten to get us back on schedule. We're not far off schedule, but it was scheduled for half an hour, 15 minutes. So, reconvene at 3:30, and then we have the final set of presentations. Thank you very much.

Abigail Smith [04:13:43] Our next presentation is in person, Lauren Fisher, lead, government affairs, and Steven lead pricing and contracting AbbVie Corporation, the floor is yours.

Lauren Fisher [04:14:05] Well, first off, but thank you very much for the opportunity to provide AbbVie’s feedback on the scoping paper for the consultation on the board's guidelines, we do appreciate the opportunity. AbbVie is Canada's third largest pharmaceutical company, and we strive to have a remarkable impact on people's lives across several therapeutic areas, including immunology, oncology, neuroscience, and eye care. We have offices in Montreal and Markham, and we employ 1100 people across Canada, we operate over 580 trial sites here in Canada, which is second only to the number that we conducted in the United States. We are a member of both Innovative Medicines Canada and Biotech Canada, and we're aligned with their feedback to the PMPRB's scoping paper today with the purpose of our presentation is to provide some additional context from AbbVie's perspective. Given the time constraints, our remarks will focus on five specific guidelines recommendations which relate to themes one, two, three, and five of the scope. Our first recommendation is to align the guidelines with the PMPRB’s legislative mandate. The second is to provide stable price ceilings, the third is to preserve the incentive to seek new indications. The fourth is to allow price adjustments aligned with inflation and the fifth is to grandfather existing or in-market medicines. I elaborate briefly on each of those. So with respect to the first point, future guidelines must clearly align with the PMPRB’s legislative mandate. As has been mentioned today, the PMPRB’s role is unique, separate and apart from the role of other drug assessment and funding agencies in Canada. Pharmaceutical companies participate in health technology assessments by Canada's drug and Health technology Agency, Canada and Quebec, Quebec's INESSS, as well as net price negotiations conducted by the pan-Canadian Pharmaceutical Alliance, or pCPA. Out of INESSS and pCPA have mandates to assess the value of the innovative medicines on behalf of drug plans to ensure value based spend for Canadians. Through the pCPA for pharmaceutical companies are making a highly meaningful contribution to public drug plan sustainability, with aggregate cost savings on branded innovative medicines now reaching 3.14 billion annually, and this is an updated figure and I did check that on the pCPA website, it was updated. I should mention also that private insurance companies, have the ability to conduct net price negotiations with pharmaceutical companies as well. And future guidelines, in our view, should not introduce rules that go beyond the PMPRB's jurisdiction in an attempt to address matters that fall within the scope of planning management. The Federal Court of Appeal ruling in the Elexion decision held that the PMPRB's legislative mandate is to prevent the abuse of excessive pricing. More specifically, the court held that the PMPRB does not have a mandate of consumer protection at large or any general authority with respect to price control and in our view, reference country median-style criteria in an attempt to control prices are not aligned with the PMPRB's mandate to prevent excessive pricing. List prices within the range of available prices of the reference countries listed on the schedule of the Patent Medicines Regulations or the PMPRB 11 should not be considered excessive in our view. Two countries with historically higher prices than Canada, the United States and Switzerland have been removed from the schedule in new countries with typically lower reference prices have been added, and this change in the basket of reference countries already has the effect of constraining the prices of new medicines. The use of a price test based on the median of the PMPRB 11 goes beyond the regulation of excessive pricing. There may also be circumstances where prices above the range of those in the PMPRB 11 countries are justifiable in relation to the pricing factors set out in section 85.1 of the patent act, for example, there may be situations where international prices for medicine are below prevailing prices in Canada for medicines in the relevant therapeutic class. The new guidelines must be reflective of these situations to ensure that the PMPRB’s role is respected. The scoping paper proposes an expedited review mechanism based on prices being below the median international price. In our view, this would be inappropriate given the PMPRB’s mandate to prevent excessive pricing. Furthermore, it would not serve to accelerate the introduction of innovative medicines in Canada, AbbVie supports policy advancements to speed up access to medicines by Canadian patients who rely on public drug plans. However, the necessary policy changes sit within the scope of drug plan management and are outside the jurisdiction of the PMPRB. Turning to our second recommendation, it is critically important that the PMPRB’s path forward provides stable price ceilings over the life cycle of a patented medicine. Once the selling price of a medicine is established at its introduction to the Canadian market, the PMPRB staff should not reassess the ceiling price over time for any reason. Price stability and predictability are foundational to any industry, but they are especially important to sustain the development of innovative medicines, which require very long research, development and planning timelines. This approach will further the federal Government's goal of supporting innovation and investment in the pharmaceutical sector, as described in its Biomanufacturing and Life Sciences strategy. Our third recommendation relates to preserving the incentive to launch new indications for in-market medicines. Medicines, of course, can have multiple indications which are added to Health Canada's product monograph as research evolves over the product’s lifecycle. This is often the case for cancer medicines, for example. Under the previous guidelines, new indications granted for an in-market medicine did not trigger a price review. It's important that this approach is maintained, as this will preserve the incentive to seek new indications for existing medicines in Canada, including indications for small populations and pediatric indications. In relation to price adjustments, changes in the consumer price index is a factor set out in section 85-1  of the patent act. This should be considered when assessing if a medicine has been sold at an excessive price. The future guidelines should, in our view, offer clear, predictable rules governing price adjustments aligned with the consumer price Index. Turning to our final recommendation, it is AbbVie's position that existing medicines with Health Canada notice of compliance prior to July 1st of 2022, and their line extensions be grandfathered and not subject to future guidelines. Medicines launched under the previous regime were not accessibly priced under the PMPRB’s rules, and should continue to be subject to the previous guidelines frameworks with ongoing oversight of inflation-based price adjustments. In conclusion, the PMPRB's guidelines are an important element of pharmaceutical policy in Canada, and the stakes are high for patients and the entire health care system. The consultation process for the guidelines should therefore be robust and meaningful, we would recommend that the PMPRB conduct an impact analysis and case studies for discussion at working tables with industry technical experts and other stakeholders, as well as inviting them to sessions. This concludes our remarks today. Thank you again for the invitation to present, and also for considering AbbVie’s feedback as part of this consultation.

Peter Morland Giraldo [04:22:42] Thank you so much, very interesting presentation examples. As part of the new guidelines drafting process, I'm sure staff took note of that and working examples could be certainly helpful for everyone to understand. What do you mean by this, what you put into these guidelines and strategies.  I do have to wonder if you can help me with a contradiction I see. Item number two is a call for stable price ceilings, and then I see number four is, with adjustments for CPI. So, you know, we have these three factors really that we focus on at the board, one is CPI and the other two, and so I think what you're actually calling for is a stable price floor, because if we agree to a non excessive price at the start that you want to go up from there, or you think that's a legitimate, that's what the legislation permits. Is that right?

Declan Hamil [04:23:46] Yeah, I believe that’s correct, what you've articulated.

Peter Morland Giraldo [04:23:50]  So then how do we deal with this figure three that we have that has the median international price going down at the same time. Is there anything in the legislation that allows us to say okay, we're not going to pay attention to that, we're only going to pay attention to the CPI?

Lauren Fisher [04:24:09] I think it's hard to answer that question, because we don't really kind of have the context of everything that's being contemplated. But I guess in terms of, as it relates to like re-benching. But in terms of that theme of re-benching, you know, we would prefer looking at, recommending stability that would, kind of not include that re-benching.

Peter Morland Giraldo [04:24:34] You mentioned that you would be opposed to any price test that sets the median price index, the median MIP as, as a target. So with our interim guidance, we put in the MIP as a purely as a triage, because we had identified at the time, those of you with eagle eyes would notice that we had identified 55% of the new medicines were actually below the MIP. That number has changed in the scoping paper. We now have only 34% of new medicines. And that was because in the few months between when we first proposed that and the time we did the scoping paper, the median international price had continued to go down, so only 34% of the medicines were actually now below the MIP. You're simply proposing that as people who want to come in at a lower price, we feel that below that price deserves, requires less scrutiny from us. And would that not motivate, at least some innovations in the space to give them a clear path below the MIP, but it's not a, a binding patent.

Lauren Fisher [04:25:47] That's a difficult, it's difficult.

Peter Morland Giraldo [04:25:55] So I am giving you the hard ones.

Lauren Fisher [04:25:57]   I think in Turkey, we understand the interim guidance, but in terms of… I think it's unpredictable right now to see what's going to happen in the future. So it's hard to answer that question. I think in terms of the mandate of the PMPRB, our comment is, is that the HIP context of the mandate of excessive pricing, maybe the HIP would be more appropriate. Certainly understanding that we’re in a kind of interim situation right now.

Marie Thomas [04:26:59]  But I guess excessive pricing is at a hearing? We can only determine that at a hearing, right? So before that we did the administrative ways to be more efficient here at the PMPRB, so I guess that's what you're alluding to when you're talking about it, and I guess that's the question we have for you. I've been asking this to others as well as where is the trigger? I mean, in the interim guidance, the MIP. Where would that be for you?

Lauren Fisher [04:27:45]  I think the trigger would be the HIP.

Marie Thomas [04:27:52] So anything below that.

Peter Morland Giraldo [04:27:54] Would you take MIP plus 5%?

Lauren Fisher [04:28:05] That's a difficult question, probably not able to answer that question. Thank you.

Peter Morland Giraldo [04:28:22] Thank you very much for the interesting... exactly in our zone of interest. Thank you for doing your best to answer those questions, it was  very difficult.

Lauren Fisher [04:28:39] I'm sure they'd love to be in our place.

Phil Azzie [04:28:56] So, our next presenter is Damon Goodwin, CEO, research, New Brunswick. The floor is yours.

Damon Goodwin [04:29:04] Thanks very much. Thanks very much. And sorry for the technical difficulties when I was trying frantically to join. I think Gary can attest, I did email him several times, so, hopefully, all is good. And I'm just going to share my screen. I'm Damon the CEO of Research New Brunswick, and just going to get that up and running, and hopefully everyone can see my screen.

Marie Thomas [04:29:36]  Yes we can.

Damon Goodwin [04:29:38] Very good. So, we'll start with my disclosure statement. So, research needs an arms length, not for profit with the mandate to fund research, measured the impact of that research. Coordinate research provincially, regionally and internationally. And then to promote the value of that research and the impact reports, our funding sources, we get core amount from the government of New Brunswick. We are also official partners of Tri-Council agencies such as the CIHR. We work with all of the federal agencies. We work with industry partners, and also with NGOs like the Heart and Stroke Foundation. We are a recent amalgamation of two entities, one that was around for 15 years, called the New Brunswick Health Research Foundation, which is one of the NAPHRO members, one of the national, one of the members of the National Association of Provincial Health Research Organizations and the BIONB or the equivalent of life sciences Nova Scotia, life sciences Ontario. We're not a member organization. We are, like I said, government funded for core funding from the province, and then we leverage that and stack that wherever we can find another dollar. So and we have a, a pretty wide mandate that includes health and other areas. So if we look at the ISED research continuum, we fund and invest in people and skills, fundamental research through the universities, health authorities, etc. and then applied research and partnerships up to and including commercialization, where we have other entities in the province that look after that. With the exception of perhaps health systems change or post-marketing surveillance projects, phase four trials, that type of thing. We have three major buckets where we look at research, we have fundamental research which everybody as well, likely understands that basic researcher-led project, the curiosity-led research we have applied research that is around developing products or systems for implementation. And then we have an intentional research bucket. And this this bucket is essentially when a government has a desire or interest to fund in a certain area. We gladly accept additional funds to develop research projects specifically to address government priorities. We work with everybody in the ecosystem here in New Brunswick, including the universities, private sector, national partners, regional health authorities, medical schools, et cetera. And again across forestry, agriculture, energy, agriculture and health and life sciences. When we look at research and innovation spending in Canada or incurred government expenditure on research, based on the OECD report 2023 we can see clearly that Canada is not spending to that 2.5% of GDP recommendation, as are most of the other countries in the G20. And we sit at 17 of the top countries. So Canada needs to be doing more, in the form of investment in research and development and then we look at, New Brunswick, New Brunswick, sadly, it needs to do a little bit better job in that area as well. I put those two slides in there essentially to kind of set the bar around how much money is going into research and innovation. And I think we can all agree that we should and could be doing more and not just government, but private, NGO, government, all together working together to solve big problems. Key issues, with the latest, the recent history from the PMPRB, I think, when I looked at the report, and got the opportunity to weigh in in here, I believe that research dollars from industry are directly impacted by market access issues. That there is a perception that reimbursement pathways post regulatory approval are leading to delays in the market. So again, that CADTH/INESSS [04:33:40] and pCPA pathway is taking too long and there's a lot of presentations that touched on the specific statistics. And I think we can all agree that we are not, doing a good job as perhaps we could be, in Canada from an access to innovation medicine perspective. Uncertainty or lack of clarity from regulatory bodies always causes a problem when you're looking at whether it's investment dollars or in research or whatever we're looking at in particular and, has negated perhaps opportunities for post-market research projects, knowledge translation programs, health systems research and real world evidence programs. We've been investing heavily in our provincial data steward, part of those core programs along with the CIHR and there are some terrific opportunities at looking at new and innovative pathways for pricing by looking at value-based pricing and other, innovative methods used around the world, and I believe that doing research on those programs to see if  there really is value in something we, again, could likely agree would be a great way to explore the viability of those programs. There's that perception of regulatory reimbursement pathways being slow. And again potentially duplication of effort when setting prices where the pCPA negotiates a price, CADTH looks at that health technology assessment and measures of price, and then  if we have an additional authority doing that. And I was glad to see in the sixteen teams put out by the PMPRB that  they really want to be strictly involved with the policing efforts, which I think is important and valued. So concerns exist for some stakeholders that government agencies may not be including their perspectives, I think that was heard loud and clear with everyone talking about working groups. And I think, the panel has heard that, very well, and we would love to support and participate in anything, that that goes in that direction. So again, we like the idea of sticking with monitoring pricing without price setting, we are very, very thrilled with the insured and continued collaboration efforts such as these very consultations. Congratulations, we applaud that. We do like the idea of a working group that is established to support guideline development, implementation and ongoing performance of the PMPRB to ensure it's meeting the needs of all stakeholders. Again, aligning with pan-Canadian health partners, that's excellent. Industry needs time to adjust to new regulations. So this is where the grandfathering conversation and I appreciate the comments back and forth from the panel on that, and that that's not super easy necessarily, but I think things that we can do down that road, and perhaps we use research as a way to bring evidence to support decision making, could be, something that works there. And then, again, those clear, predictable, transparent processes are really helpful for everyone as we adjust our planning efforts. So in conclusion, PMPRB plays a vital role in protecting Canadians from excessive pricing. We strongly support your mandate, and I think everyone recognizes that value. But all of us, we need to work a little bit better together. And again, evidence of that working together is already happening in these wonderful consultations. So again, we appreciate that we can do more together, and we want to assist in any way that we can do that. Government cannot accomplish a lot of things alone, and I would say innovation is right at the top of that. And so having the innovators, invest in Canada and in research in Canada is again vital. So I'll end my presentation there and accept questions from the panel.

Peter Morland Giraldo [04:37:46] Thank you, Mr. Goodwin. You're welcome. Very interesting view from the research end of the business. Really, you're deeply involved in it there. But I was interested, you're very intuitive about pricing innovation, there's different ways that pricing can be done. And I would be afraid if we would have guidelines, we might sort of accept some sort of traditional method of pricing when, as you say, we could some products might be moving towards value-based pricing. So, could you help us understand that a little bit? I mean, it's a different way of the list price is not really the list price In that case.

Damon Goodwin [04:38:28] Yeah. So, value-based pricing has been defined a bunch of different ways, but I think most simply, if you think about a product's efficacy in the market, so clinical trials say the drug is going to do this, it's going to provide this benefit whether that's a patient outcome or health systems benefit or whatever the claim is through the clinical evidence, whatever that suggestion is of value, then the deal with the government or the payer or the private insurance company is if the drug does what you say it's going to do we will pay this price, and if the drug does not do what you say it's going to do, well, you don't pay that price. A good example could be in an oncology product where seven months of additional life is what was seen in the clinical trials and the government says or that company says, you know what? We're willing to sign a guarantee that if your patients in your province are not achieving seven months, you're getting less than that, you're getting five months or no months, then you don't pay, but if we do better than that, then we'll pay the current agreed upon price. So it's a risk sharing agreement, and that's something that I think we should be researching, exploring. Is that a good thing to do? Well, why don't we take some pilot projects? Why don't we choose some drugs? And during Covid certain countries in Europe did explore this kind of approach where regulatory approval they gave approval on the drug and they worried about the pricing a little bit later. Health technology assessment negotiations with companies happened later, but patients who needed those innovative medicines in really critical situations like cancer, and  potentially other situations could benefit from the drug or not. And if they didn't benefit from the drug, well, then the industry was on the hook. My understanding and my conversations with industry that they're interested in exploring these kinds of negotiations with different payers, and that there are payers who are very interested in that. We've engaged in a couple of research projects with between, provincial government and regional health authority and company that are exploring exactly that as a pilot project to evaluate the real world impact of the medication. One of the other pieces is that we've been investing for several years in the New Brunswick Institute for Research, Data and Training, worst name ever because nobody can remember what it is, but, that is our provincial data steward, not that much different from ICES or RAREi and the other provincial data stewards, but we put legislation into that database that allows the sharing of that data for research purposes only. And so that data collects all the health data from all of the regional health authorities, from the system as a whole. It also collects educational data, income data, judicial data. And we actually have pharmaceutical companies that are engaged in research looking at policies around Ritalin in the 1990s.[04:41:38] Was it a good idea? What happened to those kids? Did they go to jail and what were their incomes? How much time did they interact with the health system Are they more prone to speeding tickets? Right. Like, in the database, we can actually look at that, so having that kind of data available, could we look at drug utilization and actually measure if society is benefiting from it. And I think the innovative medicine companies that believe that their innovations work are more than happy to put some money on the table for that. And I think that would be another area where Canada could lead and, and coming up with new and innovative ways to solve some of these problems of getting great access to great medications at a reasonable price.

Phil Azzie [04:42:34] Thank you very much for your presentation.

Damon Goodwin [04:42:37] Thanks for having me. Sorry for the technical difficulties.

Phil Azzie [04:42:43] Well, then the next presentation will be in person and it will be Shelita Dattani, Senior Vice President, Pharmacy Affairs and Strategic Engagement at Pharmacy Association for Canada. Welcome. The floor is yours.

Shelita Dattani [04:42:58] Thank you so much. An immense relief of pressure not being between you and the end of your day, I suppose. And I'll try to try to keep everyone engaged. Thank you so much, everybody. So my name is Shelita Dattani, I'm the Senior Vice President of Pharmacy Affairs and Strategic Engagement at the Neighborhood Pharmacy Association of Canada. I'm also a practicing pharmacist right here in town. I grew up in my dad's neighbourhood pharmacy in the West end of Ottawa, where he took care of his community for over 31 years. I want to, first of all, congratulate the board for their forward thinking in a more informed, focused and productive consultation and broadening the stakeholder perspectives of two additional health partners in the Canadian pharmaceutical landscape. We want to thank you for inviting us to today's roundtable. Community pharmacies have a very unique and active role as the final drug distribution access point in the entire medication supply chain, and we're pleased with the opportunity to provide what we feel is our critical perspective. So I'll tell you a little bit about who we are. The Neighbourhood Pharmacy Association of Canada, otherwise known as Neighbourhood Pharmacies and represents leading pharmacy organizations across the country, including Chain, Banner, Long-Term care, grocery chains, specialty pharmacies, small, mom and pop independent pharmacies, and mass merchandizers with pharmacies as well, in advance the delivery of care of pharmacies and their teams at service integral community health hubs in urban, suburban, rural, remote and First Nations neighbourhoods. As the association representing pharmacy operators across the country we act at a pan-Canadian level to support policymakers with the development of innovative solutions that allow pharmacists and their teams to support primary care, while advocating for fair and sustainable funding for community pharmacies. The PMPRB scoping paper sets out six themes for discussion, we've discussed a lot of those today. Our remarks will pertain to themes five and six, and you'll see that I'll cover off some of this in my remarks, but I have to clarify any of the questions so they don't cover off at the end, and happy to be more specific in our, subsequent written submissions, to health partners in alignment with broader government initiatives and engaging with patients, health care practitioners, pharmacy and other stakeholders. So we'll address elements of the themes, as I said, including some elements of two in our written submission as well. So just to give you a little bit of a perspective on the role of Canada's community pharmacies, Canada's more than 12,000 now community pharmacies across the country, and are 37,000 pharmacy professionals, we serve as vital community health hubs, we bring primary care and public health services to community, and I'm sure some of those services have touched all of you. And some of you on the board today and in all kinds of communities, as we've said, we're often the first and most frequent touchpoint that Canadians actually have with the health care system more than ever now, and pharmacies typically have extended hours we’re open on the weekends, we give Canadians accessible primary care close to home where they work. Since the start of the pandemic, our members have offered accessible, critical support to patients and communities, and we continue to be a partner to public health, primary care providers, and governments. And this partnership has ensured the continuity of patient care to keep Canadians safe and healthy. We administered nearly 25% of all Covid vaccines in the country during the pandemic, we provided the assessment and testing services we offer and continue to offer expanded minor ailments prescribing, which has recently expanded across the country, and we dispense approximately over 800 million prescriptions in a year. Pharmacists in all jurisdictions have adapted their practices, and we really now consider [inaudible] of having health clubs. We bring necessary health services to Canadians, we respond to challenges across the country, we build capacity and a primary care system that is struggling through expanded authority without a lot of these services that I just talked about. And we've also been instrumental in protecting Canada's medication supply by mitigating medication shortages again, something that we hear and read about every day in newspapers. Just doing an interview about this yesterday, in fact, right at the pharmacy counter while maintaining patient access to essential medications. So we're committed to working with the PMPRB to improve our health care system for all Canadians. And we all agree that Canadians need access to affordable medications but this policy objective needs to be accomplished in a manner that does not jeopardize patient access to those same very medications. We share your belief that innovative work is needed to provide greater access to health care across the country, and the pharmacy sector can be a resourceful partner in many ways by supporting and collecting better patient health data. Pharmacies are quite well placed, actually, to act as several different points of care, to collect data and evidence to support greater access to primary care. As I alluded to several times, and to address some of the real and very salient health and human resource challenges that we are facing today in our health care system. What we need to remember is that pharmacies depend almost entirely on the funding generated through dispensing fees and markups that aren't tied to drug prices to support all of the clinical and patient care services they provide. They use these funds to pay their staff, to maintain their inventories and to pay their rent. We also use these funds to deliver a wide range of care and services that are otherwise unfunded, of which there are many, and while dispensing fees and markups are provincially negotiated, any changes at the federal level on medication pricing policies have an immediate, direct and proportional impact on markups, funding, and a pharmacy’s ability to sustain the delivery of medication, care and services. At the same time, the pharmacy sector is also operating under considerable strain due to increases in labor, warehousing and fuel costs combined with record inflation and workforce shortages. As I alluded to past, our operating costs are rising, critical funding tied to medication pricing is decreasing, and the pharmacy sector has no avenue to offset these losses. We cannot pass these costs to our patients. So this severely constrains our sector’s ability to provide the care and service that we provide every day, and without fees, Canadians just simply can't get their medications. And again, given the strain we have on primary care today, how we help our communities, just to really serve all medication related health care becomes immediately compromised. To date, adjustments through the generic pricing framework negotiated by pCPA have already removed millions annually from community pharmacies across the country, and the impending new framework is estimated to further reduce pharmacy funding as well. Projected annual impacts on the pharmacy sector as a result of expected changes from the PMPRB review guidelines on drug pricing are over $100 million. The predictability and consistency of medication pricing will just support better business planning by the pharmacy sector which will in turn facilitate our ability to provide that sustainable patient access to the medication. Businesses need predictability and I won't go into this too much today, it’s sort of round two. But we do we really do plan based on inventory cost, sales, and if we don't have that predictability, then there are challenges for us and that could create delays in access if we reduce our inventory, etc.. As governments look for ways to reduce drug spending, we really urge the consideration of these downstream impacts to people, who were later on in the supply chain to us as pharmacists and  health care providers, to the patients that we serve, and identify mechanisms to offset these impacts, such as reinvesting the savings. Incidentally, our funding for services is based on list price, not net price. So our services need to be sustainable and when the list price is reduced, this impacts us. We're not privy to net prices, we need to understand, and we will feel the impact, and bear most of the brunt because we are not privy to those that to those types of prices. So as you're reflecting on these considerations in the future mandate of the board, we ask you to consider a few following key points, and I'll just end in conclusion. We all feel that Canadians deserve to pay fair and lower drug costs, but they also need better access to health care. I don't think any of us would disagree with that in this room, and it's really important to understand the direct line any changes to drug pricing that have those impacts on the patient care needs that we provide, the world changed after Covid. The government responded to the needs of the health care sector by delaying PMPRB implementation. And we just would ask you to consider those broader impacts of PMPRB on the pharmacy sector, on drug deliveries to rural and remote locations, so on patient equity issues and things like that. And really encourage that sort of broader stakeholder universe that you have well presented today, and we look forward to being part of that as we move forward in the future. So I really just, you know, want to say I can't implore enough how much the concerns of my sector with respect to the care that we provide today as primary care providers is impacted by some of the reforms of the PMPRB. Working together, we have the opportunity to make a tremendous impact on the health of Canadians, but we can't work in silos. So we really feel that that working in a holistic matter and working together will ensure that you have that access to the care they rely on. Thanks for your time and attention. I know I went really quickly. I'm trying to get you guys out of here. 

Marie Thomas [04:52:11] Very efficient as all pharmacies are.

Shelita Dattani [04:52:16] Fast talker anyway, but I appropriately punctuate.

Peter Morland Giraldo [04:52:18] Thank you, thank you. Super helpful. We all care about our neighborhood pharmacies, and it's amazing how, intimate and good quality care we get. And I don't want to contradict anything you said. But I get we've heard previously and we've heard again now that list prices matter because you take a percentage on top of list and so that's… we can get why it's important for us to manage that carefully. I did have a question, though. The overall drug sales in Canada do tend to go up like the total market of sales between 4% to 6% a year. So it's going up 5% a year, the total value of pharmaceutical sales going, I'm wondering if that affects neighborhood pharmacies, if the total value of your sales are going up by 5%. So there's a certain… I realize there's a lot of complexity in your business model, but you do get the benefit of the overall growth in sales. Is that right?

Shelita Dattani [04:53:20] Yeah. That's true. And the overall growth is mostly in, you know, I would say more of the specialty products, that's a big area of growth, which, you know, many pharmacies are involved in, but that is tricky for us because it's occurring in that space.

Peter Morland Giraldo [04:53:34] So there's some growth. And when you did say pCPA  has removed millions, it's because they've regulated generic prices and the generic, and someone said it was $50 million, or, you know, at least 50 million has come out of your revenues on that alone.  We do have to be conscious of how we fit in with the rest of the world, especially with respect to supply chain, which I agree, many of us took entirely for granted until early in the pandemic I heard some teenagers say talking about supply chain management, and I was like, okay, now we're starting to get the problem.

Shelita Dattani [04:54:13] Exactly.

Peter Morland Giraldo [04:54:14] Yeah. So thank you very much.

Shelita Dattani [04:54:17] You’re welcome, thank you.

Phil Azzie [04:54:19] I'll just introduce you again quickly. So our final presentation of the day is from Laura Tamblyn Watts, CEO of CanAge and Canada's national seniors advocacy organization. The floor is yours, welcome.

Laura Tamblyn [04:54:47] Thank you very much and thank you for the opportunity. Or perhaps not exactly the timing, but the opportunity to present to you today. Just as a quick overview, we are Canada's national seniors advocacy organization, I'm just going to be doing a very quick little walk through of our presentation, but just wanted to check that you can see the presentation up on your screen today.

Phil Azzie [04:55:10] Yes we can.

Laura Tamblyn [04:55:11] Thank you. So CanAge is Canada's national seniors advocacy organization, we represent all Canadians as we age. We’re the largest seniors advocacy organization in Canada. We're a nonpartizan and not for profit organization. And I want to take a little point and note that we work very collaboratively, and that is a point that I want to pick out, because as we're changing our tenor and tone, I think it's important that we realize that collaborative changes are going to be important. And I think that in this space, we have not always been as collaborative working with public, private, not for profit partnerships as we might be. When we think about what we need to do with regards to the PMPRB, we wanted to pull out six key recommendations, and then I have some specifics as well on the next slide. I don't need to tell you. I don't need to really tell any Canadian how important vaccines are. And we wanted to draw attention to this first off the bat. We believe that vaccines should be reviewed by Health Canada and the PMPRB on a complaint-based basis. The way that vaccines are approved and purchased takes that risk of excessive pricing right out of it. We know how important it is to make sure that the right, most innovative and most appropriate vaccines are in the arms of all people, but particularly for those who are immunocompromised and who are more vulnerable, like older people. One of the questions in 2.1 is what should we do with existing medicines? I just want to put the flag of the word grandfathering, it's actually a problematic term. It has racist roots. And I think I just want to flag for you that perhaps we could use a different term than grandfathering. But we do suggest that at this point that approved medicines continue to be included, we believe that the focus for the PMPRB is a difficult one, and we appreciate the balancing of power that you have to do. Our understanding is really that the excessive pricing is the aspect that we need to measure, but we need to offset that understanding about how we measure well-being of Canadians. So we've not done a great job of that earlier today, we heard some discussion about what measurements should be used. What we would respectfully submit is that many of the key measures actually don't reflect adequately the aging population or the quality of life as we age, and have sort of agist undertones in their assumptions. We really want to applaud the question of 6.4, which I know has had some focus of other key organizations. The good news is that we believe that the change in tenor and tone, and the very fact of this roundtable is indicating that the PMPRB is rethinking its relationship with key stakeholders and perhaps opening its arms to understanding that while technical aspects are critically important, that information comes from all sources and those with lived experience are the experts in their own space. There has not really been any meaningful engagement with stakeholders, and I would offer that the tenor and tone of the relationships with farmers was also deeply problematic. We believe that in order to promote a true, meaningful engagement process, that this does require standing patient and caregiver advisory working groups, not just small one-offs on narrow pieces, but a purposeful way to ensure that all information is getting to decision makers in a way that meaningfully shows that they are committed to the well-being of Canadians. We believe as well that there needs to be an audit, an internal audit, for how the presumptions of decisions are made. For example, we know that in some measures that we use, now I’ll pull the consumer price index as an example, which is one of our questions that we will speak to more specifically in a moment, that the fact that the consumer price index is actually under review is somewhat problematic for what it assumes is important to Canadians. And what we know is that the CPI and in fact, many other measurement tools are not actually measuring the real costs of things like care. That flows into my second point, which is that we need to be rethinking the cost formulation. The cost of care is not reflected in any measurement tool that we have in Canada yet, and yet never has it been more important than having it in something like the PMPRB. So when we're thinking about costs, we should not just only be thinking about just the dollars and cents of the upfront purchasing of medications, but what does it cost in terms of lost opportunity to our economy? What does it cost in terms of the lack of ability for a person to work or meaningfully engage in their lives? What does it cost on a knock on effect of caregivers? And this is going to be increasingly important as we're moving to a caregiver burden of 4 to 1, never before seen that degree of reliance on supports and free care. And just to kind of put a little bit of a demographic touch to my submissions, 2030 will not just be 1 in 5 people over the age of 65, but that's the year that the boomers turn 85, 2030 is the year that Gen Xers like myself start turning 65, so we need to have a lens-based demographic approach when we're thinking about this as well, which we submit to you is not yet done. I made mention briefly on the 3.4 how should the PMPRB treat regard to consumer price index? And I would just offer that that is kind of an inherently problematic question to begin with. We need to think a bit more deeply about what it is we're trying to achieve and where hidden bias exists. On question 4.2 how much detail should there be? I mean, this is an area where we think it's going to be critically important to not just provide good detail, but also good knowledge mobilization tools, which is an area of great need and development for the PMPRB, which has been overly reliant on complex guidelines and even more complex rulings. I took the opportunity to review and run the materials provided for this policy roundtable, including the consultation package, through Accessibility Software, and it requires a post doctorate degree to really understand the implications of this. Now, I actually have some of those degrees and I still had a challenge, I'm a lawyer who specializes in some of these areas, and I still had a challenge, and I speak both official languages, and I had challenges between the English and French. The good news is this: we have a great opportunity to ensure that we are moving in a more accessible and inclusive way to really show that knowledge is important to the PMPRB. And with that specifically, I would offer that all materials, guidelines and processes must be in accordance with the accessibility for Canadians legislation, which frankly, should be already, but is clearly not yet in that regard. The last piece I just want to weigh in on is under question 5.1. What efficiencies can be gained by coordinating decisions and timelines? You know, on a global scale, I'm almost embarrassed when I'm representing the country at the World Health Organization or the United Nations, and I'm coming to you from the UN, I'm actually giving submissions on aging. And one of the areas that we're talking about is pot and medications and also vaccines. And I'm almost embarrassed because our lack of coordination is so problematic that we are seeing both a lack of innovation and a significant delays for those who need it most, and it doesn't have to be. So I would offer, of course, the efficiencies need to be gained by coordinating your decisions with all of these organizations, but not to the degree that we wait for the last person to get on board, right? It can't be the lowest possible denominator. It needs to make sure that we are streamlining in an expeditious area, particularly taking out non problematic issues like vaccines, for example. The last piece I just wanted to flag for you is the question on rare diseases, which was question 6.3, you know, it's our respectful submission that when it comes to rare diseases, we have a different category that CanAge is fairly supportive of, it’s rare disease strategy that Canada put forward, and that we shouldn't be flagging rare diseases as deeply problematic, we should understand that it's not just an opportunity for innovation, but it is a separate thing in many cases. I also want to just share with you that in the space of rare diseases, the life course approach is also critical. So when we're thinking about funding medications, often we see in rare diseases that may only go up to 18 because the presumption is the person will simply die by that age. The good news is people are living longer with rare diseases out of childhood into adulthood. The corollary is also, as we are living longer, we are also getting more rare diseases in later life. So we need to make sure that we are thinking about age-based cut offs in a really appropriate fashion. I submit to you that there's a long way that we can go in this. And then the last question is, you know, what quality of evidence should the board consider when conducting its scientific review? Again, understanding that when we're thinking about evidence with a capital E, we often have a very narrow approach to it. We need to understand that fundamentally, medications are for people and people who need to live healthy, productive and engaged lives. And that also the ecosystem around those individual patients are their supporters and care partners if they are lucky, and those types of aspects need to be considered. Lastly, I just wanted to share with you one of the big innovations and levels of excitement and a pathway to hope, but that if we don't get it right, it's going to be a bit of a disaster. And that is, of course, that we have new medications now are very, very first disease modifying treatments for Alzheimer's disease. And we believe that is the beginning, hopefully of the end of Alzheimer's over this next 20 years. We know, however, that the cost of these medications is going to be something that we need to consider. When it comes also to the cost of not having these medications, we need to understand that dementia is one of the most expensive things that we have in this country, and that we are not, I think, robustly considering the cost of people with dementia to our broader health care system. For instance, about 86% of people in Canada in long term care are there because of dementia. So I think that this behooves us to be moving quickly in order to ensure that we are both considering a new journey and a new pathway forward for our relationship with stakeholders in the PMPRB, as well as a new opportunity to consider about what's important for Canadians. Thank you.

Thomas Marie [05:06:29] Did you actually just hang up after all of that? That's wonderful.

Laura Tamblyn [05:06:34] Thank you. Okay, the sharing is fine. I look forward to any questions you may have.

Phil Azzie [05:06:38] Can you stop sharing?

Thomas Marie [05:06:40] Sharing is paused. It says my sharing is paused, are you also seeing that it is paused.

Phil Azzie [05:06:48] We don't see you anymore.

Laura Tamblyn [05:06:50] Okay, well, I will try very hard to make that happen. There you go. Stop presenting. Thank you. Does that resolve it?

Thomas Marie [05:06:59] Well, we hear you but we don't see you, but that's okay, at least we can hear you, and I am assuming you can hear us.

Laura Tamblyn [05:07:06] I can and I'll see if I can manage what's happening with the windows. Let's just see if I can.

Peter Morland Giraldo [05:07:15] Thank you. So let me ask you, thank you for that your advocacy on behalf of Canada's largest seniors organization, I didn't realize that CanAge was in that position, and we're grateful for your contributions. Just to clarify, I mean, you say that Canada has as a lack of coordination around drug pricing and drug entry, but I just, you've been to the UN. My familiarity is that every country has an extremely complex and unique approach to drug pricing and innovation. So, do you have comparison to other countries, do you think we're worse, perhaps, or are we just bad? Is that what you're saying?

Laura Tamblyn [05:07:59] I think we're overly complex in areas we don't need to be, and we don't reserve the time attention for the really, truly complex issues. And I think what's important is that we focus on what we can do to streamline that effect. And perfect example is the question of vaccines. There is no reason it should go through this process when a complaints-based process would make sense and because the procurement requirements already stop the concern. So that's an example where we could take that out, and other jurisdictions around the world indeed have done so, which is one of the conversations that we're having in the United Nations here on the seventh as a matter of fact. Another example where we can streamline is in reference to your comment about making sure that we are focusing on the core of what we're concerned with, are we core concerned with excessive pricing? If so, we need to focus on that and allow that flow through of innovative medicines or medicines that we believe are just being stopped because the workflow is so heavy for PMPRB so we would just respectfully submit that there are many ways that we can streamline through, and we're very grateful to see that the consultation report  is specifying it. But again, an extra plug to ensure that vaccines move to a complaint-based approach.

Peter Morland Giraldo [05:09:18] Thank you. We did take up the vaccine question in a different scenario, and there is a separate question about individual-paid vaccines, but we take your point regarding the broad general procurement vaccines, that your approach does sound reasonable there.

Thomas Marie [05:09:35] I guess we assume she's talking about public procurement vaccines.

Laura Tamblyn [05:09:41] Well, it would be actually for all NACI-recommended vaccines, in fact. So if it's gone through the NACI-recommended process, it has already gone through it. So for instance, I'll just take because of course, and we're happy to share our materials, which of course map out which vaccines are covered in which jurisdictions, but those are political jurisdictions about what's publicly covered. What we're suggesting is that if it is recommended by NACI, it should be then moved through that expedited process. So for instance, Shingles is covered for in Quebec people 80 and over, but in you know, Ontario it's currently been lowered to 60 from 65. These are political decisions, they should not be stuck, however, at the PMPRB level.

Peter Morland Giraldo [05:10:29] Thank you and I think we need to wrap up now. So thank you so much for your presentation.

Laura Tamblyn [05:10:35] Thank you for your time today.

Phil Azzie [05:10:39] Thank you. And that does bring today's session to a close. I'd like to thank everyone, attendees and, participants, presenters and board members in particular, for making my job the easiest one today. As I mentioned earlier, the English session will continue tomorrow morning during the second part of the morning session and in the afternoon. So you are invited to return on-site if you desire. Last thing I would ask you as you leave, if you could please leave your name tags on the table. They will be there again tomorrow if you do plan to come back, but I've been asked to ask you if you wouldn't mind just leaving them on the table. And with that, I will declare the session ended for the day. Good evening to everyone.