eSignature Licitness for Drug Testing Consent Agreement in Canada

How to eSign a document: eSignature licitness for Drug Testing Consent Agreement in Canada

okay okay so i think we'll get started hello everyone thank you so much for joining us today um today we're going to be discussing the drug approval process in canada my name is kimberly burnell and i am the ontario regional support liaison for amac if you don't know who we are amac is a leading funder of research into bone marrow failure diseases in canada we support patients and caregivers from across the country who are dealing with plastic anemia myotisplastic syndrome and pnh i'm so pleased today to be joined by anil call and anil is the associate director for patient access at sobi and he's going to be talking to us about drug approval process in canada at this time all of the lines are muted um but if you have questions for the presentation there's two ways that you can do that if you want to speak directly with the nil if you want to ask your question you can use the raise your hand feature and i can unmute your line and you can have a direct conversation alternatively you can type your question into the chat box or the question box at any time and then we will cover your question either during the presentation or at the very end today the um session will be audio recorded um so if you want to watch it back later you can do so on our website um so without further ado and now i'll pass it over to you thanks kimberly i want to share your screen yeah i'm going to share that thank you very much and welcome everyone um and i want to just uh thank uh imac for uh and kimberly and cindy for inviting me to do this talk um and uh as mentioned uh my name is anil and i've been in the industry for over 20 years and i've been doing market access for over 12. and what i'm going to try to do is take on this mammoth task of reviewing the approval process for drugs in canada but what i'm going to try to do is give you an overview because it is a very complex and [Music] intricate environment but i'm going to try to make it really simple and give you an overview but you're welcome to ask questions and also if you want to go deep into any area i can also give you my information and you can reach out to me and we can have a chat offline if needed okay so we'll get going there we go so the objective of today's or the agenda for today is is to uh you know do the welcome introduction which we've done go over some objectives uh we're going to go over the overview of the approval process we'll look at some special access program look at health canada drug approval look at some pricing talk about the health technology assessment the pan canadian pharmaceutical alliance and then the provincial coverage that ends up at the end of the day providing public uh coverage in the program on in the provinces there are a lot of acronyms when it comes to market access and to drug approval i have tried to um um write all the names out and all the acronyms out but uh if if there's an acronym that i throw in there and you don't understand please feel free to ask and we'll leave some time for question and answer the objectives today is to provide an overview uh not in detail but an overview um review some of the major entities that are involved in the process um like health canada and cadet timelines for the various reviews where and how patient input is accepted and address any questions from the audience all right how are drugs approved in canada so first of all we have your drug company that develops a new drug and when they're ready and they've done their research and studies phase three trials they will submit to health canada and health canada just so that we level said what everybody does here basically decides should the drug be sold in canada so they review the scientific evidence and determine if the drug is safe and suitable of suitable quality and it works as intended health canada doesn't really get into the price it does not get into the effectiveness compared to existing drugs they just look at the drug uh and what it is it does what it's supposed to do if it's approved and we'll go through each one of these um then it um is available for people to pay number one out of pocket so if you if you really need a drug and you can afford it you can just simply get it from the pharmacy or ask the manufacturer and pay for the drug another way you can access drug once it's approved by health canada is through your private drug plans um now these are drug plans through your work and or from out of pocket that you may pay for like sun life canada life great west life uh and uh blue cross and what they do is basically um work through your employers maybe to to provide you a certain amount of coverage and usually these are pretty quick to occur although they've started doing some sort of a review as well and will and they they can take up to six to nine months to approve a particular drug on their uh on their coverage plan um and this is a very important area because i often get questions regarding a patient coming into a doctor's office and saying hey i've got sun life or great west life and my friend also has it but my my i for some reason i can't get drug a covered for me but they do because they're on the same you know they're covered by the same company so the important thing to know about private drug plans is really it's not about which company covers you but rather what plan your employer has selected for you your deductions are based on that and your drugs that are covered are based on that as well so that is a very big nuance that you need to know and be aware of because we can all be with the great west life but none of them none of us can be covered for the same drugs so once you get that that drug or the um private coverage and it and the drug is available to the public and the area that we will be focusing on is the public coverage which is with the provinces um and we're going to review the canadian um uh health technology assessment and carrot and s and i'll explain what they are in a bit but they are the ones that look at the drugs and and answer the question does the drug offer value for money they look at the clinical benefits and the cost of the drugs and issue a recommendation for or against the public funding now if you get a positive recommendation and they send you forward after their review you will land at a another agency called the pan canadian pharmaceutical alliance now the pan canadian pharmaceutical alliance their mandate basically or their job is the question that they answer is can we negotiate a lower price for the drug now jointly they they represent all the provinces and they look at the criteria and also the price of the drug and try to come up and negotiate a price in the criteria if you get approval from that body then it goes to the next level the next level is your provinces and they're the ones who decide if they will cover the drug or not under their under their plants and they're under their provincial formularies and they consider all sorts of factors including everything that's been reviewed by the pan canadian the price the value and make the final decision if they can they have room under their budget with all this going on there is another body that's involved that works across everything and which is the pricing body which is called the pmprb or the patented medicine review price board that regulates our price in canada and they basically set the maximum price of patent drug can be uh can charge for uh in cost in canada and we'll review that as well before it even a drug can even before a drug even goes to help canada if um health canada does have a program or a mechanism by which treatments are available even though they haven't been approved in canada and they're not available in canada this is called the special access program and i just thought i'd touch base on this thing because it's kind of important so it is a process that's initiated by a physician on behalf of the patient they apply to health canada for special access program they have to go in and request and provide supporting evidence any studies any case studies from other jurisdictions other countries or any research that has been done to support why they want to use this product and the requests are usually processed very quickly and then health canada will work with the manufacturer to try to get the medication directly to the patient and some therapies for rare disease and cancer end up being used through this process just so that you guys are all aware or everybody's aware that there is a process even though health canada has not yet reviewed or made a decision on a product and neil can i ask a question about that yeah so if the drug is is approved so if you your physician puts the request on your behalf and it's approved um so the government of canada will absorb the cost of that drug who pays for the drug in the end if you you do receive it um in that way so these are drugs that are not approved yet right um so once they're approved they will go through one of the other mechanisms but these are drugs that have not been reviewed or approved by health canada and these are usually there's uh there's either they will pick it up or there's a the cost will be borne by the patient um in some cases okay thank you so the drug approval process for the public coverage that's that's what we're going to focus on in the green and then we'll go step by step highlighting it in in green for you so health canada let's look at this so drugs are submitted to health canada for approval these are for new drug submissions new indications or new formularies um health canada reviews the product for safety efficacy and quality and basically decide should the drugs be sold in canada that i mentioned and the end result of the review is a notice of compliance and the acronym is noc notice of compliance with conditions and the conditions could be criteria it could be um you know certain tests have to be done so something has to be failed or or or whatnot or you'll get a notice of deficiency where it's basically rejected and you don't get approval this review usually takes 300 days to do that's your standard review there is a mechanism that they have that you can have a priority review and it's granted by having a pre-submission meeting with health canada and point out with evidence why you need a priority review and priority reviews are granted for treatments preventions or diagnosis of serious life-threatening or severely debilitating illness or conditions where a there's not no other drugs that are treatments that are existing or b there's a the product presents a significant improvement or benefit over existing products and that review period instead of the 300 days it'll it'll take about 180 days so you can cut six months off this process is mostly closed to the public and and there is no real input by the patients on this process so pricing so that's that body i've talked about the patented medicine price review board so in canada the prices are regulated in the united states a company can charge whatever price the market will bear but we have we have a this body pmprb that regulates the prices their mandate is basically to ensure that our prices in canada are not excessive and one of the things tools that they use and they have um for many years is they look at seven comparator countries and i've listed them here for you united states switzerland germany uk france spain and italy so they look at them what the prices are there and then they decide what we're going to do here now you could have only one or two or three or four of those countries that have launched the product and have a price and there's also a mechanism pmprb has if i don't think it's in the very rare instance that canada is the first one there's a price that can be charged until some of these other countries come on board and then prices are adjusted and they ask for rebates if it was too high um they also report on price trends and research and development investments so every every year twice a year manufacturers have to report to pmprb about spending on research and development in canada um the annual report from 2018 found that canadian prices were fourth highest among the seven comparative countries so we're right in the middle and that's what it's supposed to be um and as long as we don't go too high um there have been and this is a talk in itself there were some proposed changes to the guidelines of the pmprb that were initiated or or suggested um to be implemented in 2019 but they have been delayed to 2020 and now or 2019 they were developed 2020 when they were supposed to come in but they've been delayed twice um now they're supposed to be implemented in january 2022 these guideline changes are a significant departure from their mandate of trying to prevent excessive pricing they're changing the seven countries that they've been using to 11 and dropping the two more expensive countries like united states and switzerland and they're also introducing pharmacoeconomic information and net pricing that's negotiated at the pcpa level into their decision making on price which uh again um they should be they're mandated to make sure that we're not excessive and instead of trying to lower our price through the pharmacoeconomic mechanism there are some challenges with this i know a lot of patient groups have written in expressing concern the industry is certainly very concerned and there's lots of nuances behind that so we'll see what happens in january hopefully there will be delay from our perspective from the industry perspective and also from the patient perspective because we feel that drugs will be delayed and or may not even enter canada if these some of these regulations come to be so that's your health canada and pmprb once you get a notice of compliance hopefully and you are ready to go and you can sell your drug in canada your drug again goes either out of pocket or to the private plans and for the public access it goes to cadet or ines these are your health technology assessment bodies so cadet is the canadian agency for drug and technology and health and ins is the quebec equivalent so let's look at the health technology assessment so there's two um basically they review oncology and non-oncology products and the recommendations are issued issued based on the clinical studies the therapeutic advantages cost effectiveness so they look at a lot of not the technical side of things and especially the cost effectiveness these recommendations are then used by the provinces and the pcpa and i'll tell you what pcpa is in a second towards listing decisions now this hta review process is one that is more open and does request input from patients and physicians so the patient groups and individual patients can provide input through an online portal and template so so cadet will issue a notice that say drug a is now has been submitted to them and will be reviewed and they have opened up input for the patients and physicians for the next i think it's a 60-day period input is sought early and included into the in prior to the initiation of the review um and then it is also um used to support uh any of the evidence that is uh filed by the manufacturer so it's best to reach out to your association a mac um i know cindy and kimberly would love to hear about that if and when a drug is being submitted um and and sometimes a mac or the patient group will reach out to the patients as well so the patient groups can also provide feedback on draft recommendations so once a draft recommendation is issued by cadith they will send it to the patient group who submitted on the online portal and kind of get their feedback and i'll i'll review what they asked there as well so physicians and fishing physician groups as i mentioned are also asked for their input in this process and that's very uh impactful uh in the review so areas of input for the patients so you will when you go to the portal they'll ask you about your yourself or your organization they'll ask how the information was gathered um so a lot of times patient groups if there is one that exists they will reach out to patients and kind of ask you know about their own you know individual disease and then kind of put a file together and submit it online saying okay you know we surveyed 15 patients or 30 patients or 200 patients and here's what the feedback is they look at experience with the current therapies if there were any improved outcomes experience with the drug that's under review now you might get experience through a trial or through that special access program that i mentioned in the start so that they can also look at what diagnostic testing is done any other information and last but not least they ask for conflict of interest and basically this is very important for you to read and for the organization to read and make sure you answer and provide the information they're requesting and they're really looking at did you have any outside assistance and if so who provided assistance and whatnot um so that's where the patient input comes in because i'm always asked hey listen do the patients get an option need to to provide anything to their reviewers any questions so far yeah we have one um how do they compare pricing for rare disease with other countries when similar medications have not been approved before um so sometimes the so your product could be launched in other countries first um and in the case where there's no no other country has launched the product that we're talking about they will set an artificial price that they will allow the company to set a price and then they'll see what the other countries end up listing it as once they have it available in their jurisdictions and like i said to you uh before if the price was excessive they will ask for reimbursement okay thank you does that answer your question i hope if not please uh please put a follow up question in the um answer in the question box thanks anna okay um so about your uh the physicians will also be able to go to the portal and they'll have their templates as well to fill out they'll ask about the group um or about the clinician how the information was gathered um again same thing was it one in individual or was where a bunch of physicians consulted current treatments treatment goals treatment gaps any unmet needs place in therapy additional information they also have a conflict of interest now again i've kind of highlighted kind of underlined this because sometimes uh amac and patient groups end up helping patient groups and or patients provide some of the information to this to the hta and you really need to to know what they're asking for in this conflict of interest and it states in their quote unquote is each clinician that contributed to the input must complete the conflict of interest declaration so they want to know from each so if you had a 100 patients you sent or positions you sent out the survey to 30 responded um so that doesn't mean that every 100 page of the physicians need to sign this declaration or or declare their conflict of interest only the 30 that responded would have to but they would all have to declare their any conflict of interest just make sure that if you're doing this you take note another question no not yet okay oh i lied i lied it popped in just as he said that um if canada created or joined some other mid-sized countries with similar patient care philosophy or a drug-free trade bloc of sorts would that result in improved drug access and has this concept been debated so yes that's a very good question and uh it's something that uh that we uh i know that health canada um looks at it's it's very hard to collaborate and partner um they don't have a mechanism to do that with other countries but what they do do is look at what england does they have a review body just like rhta like karith and nas they have something called nice um it's a great acronym for them and they do their reviews and sometimes um cats will follow what they're saying or be very interested in what they're saying fda also their interest in what they're doing and what their outcomes were and findings were but they haven't really come up with a way to um collaborate with the number of countries per se but they do have um they do ask questions of each other i know health canada will reach out or charlotte will reach out to even australia and see what they've done in their reviews and stuff so there is some collaboration but there's nothing formal canada likes to think and it does do its own review they may look at other jurisdictions but it does its own review hopefully that answers that question thanks for now yeah wouldn't that be great if countries actually came together for this wonderful purpose but i don't i know it's not that easy yeah and you know what it's i wouldn't be surprised because we are living in a global economy and a lot of things that we do in canada are affected by what's happening around the world especially in access um and yeah a lot more and more collaboration is going on i mean not too long ago before all this came to be all these bodies that i'm speaking of didn't exist a few years back because each province used to do its own review so not to be redundant they created these hta like or cdr and peak order and then they also created pcpa and stuff so once you've provided your feedback review is done cadet will provide a recommendation which will be then shared by people who have provided input and basically there's six yes or no questions um the first one being you know a stakeholder agreement on the draft recommendation it's a yes or no but you can also provide some explanation the other five questions are basically yes or no questions and uh the fourth one being two part or two questions and and and that's something that you can fill out as well so you provide some feedback on their draft recommendations before they actually make it an official recommendation so quebec has e-ness um and it's uh manufacturers submit brand drugs generics and biosimilars to an s for evaluation um the review focus is on therapeutic value cost effectiveness and impact on the health budget budget impact analysis the review takes about six months and a priority review option is available for urgent medications patients and physician input is sought in this process and that process is actually a little different where a questionnaire is filled out and submitted to an s by both the physicians and the patients any questions on that nothing right now excellent um so again cadets reviews in s reviews they give a recommendation list but not at this price list but not you know with this criteria list blah blah blah so but as long as you get an approval from a positive recommendation from karate nest you will then especially on catholic not only ness catit if you get an approval you go to the next stage which is your pan canadian pharmaceutical alliance which is your pcpa now as i mentioned pcpa was established in 2010 to provide a joint provincial territorial negotiations before they used to do this on their own each one you would go to each province negotiate a price negotiate a criteria and that's why there was a disparity between provinces one was covering the other was in uh and and for different criterias and at different prices so this kind of makes it more uniform they look at uh they want to uh the objective of this uh pcpa is to increase uh access to effective uh drugs achieve lower drug costs they figure they're negotiating as a combined body is as as the question was why don't we all you know partner with other countries this is partnering with other jurisdictions within canada um reduce the duplication of effort and resources and improve consistency of decisions all brand name drugs come forward through cadith are considered for pcpa negotiations and concluded with a letter of intent loi this letter of intent is critical um and it basically means you you've reached an agreement on price and criteria and the pcpa members include all provinces except quebec territories and the federal plan once an loi is issued the manufacturer may then proceed to provincial listing agreements and not all provinces are bound to list a product i'm going to make a note of that so this is important because before the negotiation even starts with a manufacturer um provinces go i'm in i'm out on on drug drug a we don't want to list it we've seen the information because we have to submit dossiers to each province anyways so you could have a a case where a product is with under negotiation with pcpa ontario says we're in bc says they're not alberta says they're not saskatchewan says they're in and and the maritime say they're in so you negotiate a pro price based on potential number of patients and whatnot this is from a manufacturer's standpoint but no province is bound by their decision to enter into that negotiation or not so they can pull come in or out of those negotiations at will so once a deal has been struck they can say oh yeah i'm in now bc can decide to come in and ontario can say you know what we were in but we're out and now you've lost this huge market uh and you've maybe given discounts considering that you're going to have a larger market so it presents a real problem from a negotiation perspective as to who's when when you don't have certainty as to what kind of uh um which stakeholders are in which are not the average negotiation price or period is 10 months um the last i heard which was a couple of months ago um some files take as little as two months and some are over two years it just depends on the negotiation and where it's going and and various factors it could be on the price of the drug um and rare disease is always a challenge just to give you a perspective pcpa activity over uh this past year as of yesterday i pulled this yesterday from their website so they've got active negotiations in 30 um with 30 products 20 non-oncology and 10 oncology products so basically right now they're actively working on negotiating with manufacturers with 30 manufacturers they have 34 under consideration for negotiations so that means it's probably just come out of cata review and are preparing dossiers and our proposals and are looking at how best to um list the product kind of comparing it to what's already available what kind of price is already available what other products are are in the market or therapeutic class comparison completed negotiations there's been 454 completed of those 393 received a letter of intent that letter of intent again is a price and a criteria and or any other negotiated items that are contained within the agreement that can go to the provinces and 61 of those have ended without an agreement so no letter of intent and therefore it has not reached the provincial um province's coverage and this is something that i should mention at this point is with this creation of pcpa if pcpa does not get you give you a letter of intent you cannot go individually to the provinces to try to list your drug in the provinces they will not allow that and their that is discouraged and uh and your your road basically ends uh negotiations that were not pursued are 85 and that's where manufacturer and or pcpa have decided not to negotiate um because they wanted the discounts to be too high from from from a manufacturer's perspective and they've left it um they've they've kind of made a decision basically not to go down the public reimbursement path and just stick with the private insurance and or out of pocket and or they're distributed in the hospitals clear is mud and no once a um once a province opts in on a drug is the price set for each province or will the provinces then each on their own set their own price for that drug the price is set okay so provinces cannot change them once the price has been set yeah basically uh the negotiation so what happens in that negotiation is you have your pcpa office and and the provinces designate one province as their negotiator so the manufacturer sits down so it could be ontario's designated for product a alberta for product b bc for product c so they kind of represent the other people who are in are the other provinces we're in and once a price is negotiated that's done on behalf of everybody who's kind of in okay so if i'm a patient in ontario i'm going to get the same access to that drug as a patient in a different province the price isn't going to change no okay you're not going to get the same access i'm going to get to that okay because ontario can decide not to list even though it's gone through the pcapa process and they have a pricing agreed upon they can still decide not to list okay i'll wait to find that open yeah so like i mentioned this pcpa nobody's bound to this you can even say like i said you can say that you're in or out but you don't you're not held accountable to what you've said at the onset of the negotiation you can opt in or out at any point and that's a huge benefit to the provinces and a detriment to anybody negotiating it's basically you don't know how many units you're selling that's right well you're what your market is and you're supposed to negotiate with those terms okay perfect um and so now once you get a letter of intent and approval basically from your pcpa and you've negotiated a price and a criteria and everything is all good uh it goes to the provinces now the provinces who said we're in they can then they will then review what the uh pcpa did and then decide if they can afford it and what the budget impact will be there in uh in their province and decide uh to basically enter into a listing agreement that's called pla provincial listing agreements and once that is done it is put on the formulary and available to the public on the public broadcast so federal government has the final say so the territory or the provinces have the final say in the decision whether medicine is publicly funded or not that's that's the bottom line so we've gone through all these processes but still it's the province's decision because at the end of the day federal uh governments give a transfer fee to the provinces for for health care and it's the provinces who hold the purse and decide what they can afford or not afford the federal government has the final sale on their six formularies of your nihb your first nation inuit veterans canadian forces members designated migrants rcmp and corrections canada so basically there's 19 public formularies each with their own review and decision making process patient groups and and patients can have an impact at the provincial level with effective advocacy i've seen this being done in past i've been involved in some of it basically you can encourage your province to be part of a pcpa negotiation and say listen uh we really need this medication so there's some pressure that can be put or some education that can be done by not only patient groups but by physicians with politicians and bureaucrats and media campaigns so that it's um people are aware that for example a new drug is available that could be a significant improvement over what's available now oh question yes i see it there is it often true a drug simply won't be made available in canada even for private purchase if not approved for government funding because sales volumes would be too small for pharma company to go through the regulatory process absolutely yeah i've heard this one before too yeah so what happens in those cases remember that body i spoke about that regulates prices excessive prices um they have sometimes come back and said listen you know yeah you your new new product i can tell you from experience it's innovative like biologics were new and innovative back in the day when when um you know for for rheumatoid arthritis what they were using was um methotrexate for example which was cheap it's been there for 40 years so charging a new price for those biologics if they were to say yeah but your comparator is methotrexate and you got to charge you know 50 cents for your product that those products would never be launched in canada just wouldn't make sense and this is the issue we often run into with rare disease drugs absolutely and rare disease is so we are unfortunately we're trying to come up with a rare disease strategy a rare disease process in review because often we don't have trials of a thousand patients or 2 000 patients we have 50 patients we may have 10 patients in some cases our company i know we have a drug that was recently submitted and we were going to we're looking at roughly 10 patients in canada it's a challenge and i get it it's a challenge for the reviewers as well but i think there's some dialogue and discussions that can take place where evidence can be generated after its approval and in partnership together to see if it's working or not and it's working properly thank you perfect good question so how long does it take to get drugs covered as i mentioned health canada is about 300 days unless you're in in party review which is 180 your carat review can take six to nine months then your pan canadian alliance as i said it can take anywhere from three to 12 to 24 months public plans after that in the provinces can take one to six to 12 months it all depends or never and basically you're looking at 10 to 10 months two years plus for that public um reimbursement after health canada said this drug is okay to be sold in canada now oops you know i'm missing uh i don't know why but i'm missing a slide here i'm just going to escape i'm going to show you this slide i don't know why it's hidden this is a look at the public coverage rate for new drugs back from 2009 to 2018. this is a great picture illustration of what really happens and this is from the their website only 26 percent of new drugs approved by health canada between 2009 and 2018 were covered by public drug plants and here are some numbers on the bottom is pei 20 percent bc 21 ontario 32 34 is the highest on average it's 26 percent and the average time was 690 days from notice of compliance which is again it's a reminder from health canada so after health canada approves it it's taken almost two years and most of these lists are as special authorization worse versus full benefit so basically there's limitations on how they're prescribed and when they're prescribed any questions on that nothing right now perfect i'm going to leave about 15 minutes for any questions that we haven't addressed or any discussions anybody has any questions you're welcome to raise your hand or type your question into the question box or the chat box thanks so much and now that definitely answered a lot of questions that i know i've had and questions that i've received from patients that was really helpful thank you yes no problems um yeah i can i can stay on it people have questions or they want to ask anything for a couple of minutes if not then we can give some time back to people sure nothing coming in just yet um but is there a way to reach you you know and if folks have more questions you can always reach us and we can connect you or do you have um are you able to provide your contact info yes i can um what's the best way to do that i can tell you what my email is sure yes anil a-n-i-l dot call k-a-u-l at sobie sobi.com okay i'll just add that into the chat box and then uh and then my my cell number i'll give you as well two zero four triple nine four seven two two four seven two two i'm just putting that in the chat box for yeah for folks and we'll share the slides well that's okay yes we will be sharing um uh the slides will be available the the session is recorded and so you can watch the session back which will include the slides um if you'd like to have a nail slide sort of in pdf um feel free to reach out to us and we can um we can send that to you all right i don't see any other questions so we'll uh we'll say goodbye then thank you so much i know i really appreciate your time oh oh see right on the buzzer right on the buzzer okay um i have read the covet experience has created an opportunity for sober second thought regarding the new drug approval process thoughts on that yes so um kovit has actually shown us that although there's this lengthy process that can be shortened when when people put their mind to it right um and but but uh is that reality for all the drugs and all the products now i mean resources are a challenge you saw the number of negotiations number of drugs that are approved by health canada um it is it is a challenge i mean i'm not saying by any means but certainly we would love to see a faster process partnership we've approached the government as an industry to see how we can collaborate on this but there has to be a willingness to do so um you know we would welcome a faster process especially in rare disease you know sometimes we need to approve something especially where where there's uncertainty with with small numbers and then work together like i said before in collaboration to maybe have a registry or to to monitor and track um the outcomes and if they're not what the studies were born out to be then then yeah the hook should be on the manufacturer and uh and not on the pairs yeah that's a that's a really great point it's a good question a colvette has changed so much um in healthcare i hadn't really thought about the the drug approval process but that's a that's a really good point and we just have one more question here um is there still time for patient advocacy groups to push on health canada um you know to sort of do their advocacy work there there seemed to have been no manufacturing of vaccines in canada because of public policy made it unprofitable to manufacture here so is there anything that um advocacy groups can do to sort of push on that um certainly um health canada is is approachable uh patient groups and patients can reach out to them um and let them be known um this is one thing about another uh topic that uh i've spoken on about advocacy if people don't hear about any concerns and stuff they feel it's out of sight out of mind so it's very very prevalent in politics and in in advocacy so it sometimes is best to um approach and let the concerns be heard or or bring your concerns forward because in politics they're not hearing about it to them it doesn't exist so i would encourage people to reach out to health canada if that is you're passionate about that and uh see what they say and pursue it for sure okay i think that may officially be the last question well again and i want to thank you so much for your time today and thank you to everyone for coming today again you can find this presentation that will be available on our website um if you need any support or looking for information um on a plastic anemia melodious plastic syndrome or pnh or any other rare disease um please feel free to contact us you can follow us on facebook twitter or instagram um thank you so much everybody and have a great day thanks thank you thank you kimberly and uh thanks to me and uh thanks to umack anytime have a great day thank you bye