Legally Speaking with Michael Mulligan
Legally Speaking with Michael Mulligan
When Nine-Year-Old Charleigh's Life Hangs on a Ministerial Decision
What happens when a child's life depends on a medication that costs nearly a million dollars per year? In this eye-opening conversation with Michael Mulligan of Mulligan Defence Lawyers, we take a deep dive into the tragic case of nine-year-old Charleigh Pollock from Langford, who suffers from the rare genetic disorder Batten disease.
Mulligan walks us through the complex web of legislation governing medication coverage in British Columbia, revealing the stark truth about how these life-or-death decisions are made. Despite common misconceptions about universal healthcare, the reality is that medication funding falls under provincial jurisdiction through the Pharmaceutical Services Act. For expensive drugs treating rare conditions, the process involves a Drug Benefits Council making recommendations, but final decisions rest with government ministers and are primarily financial rather than medical.
The most troubling aspect of Charleigh's case is that she had been receiving the $844,000-per-year treatment for some time before funding was abruptly discontinued. This withdrawal of established treatment raises serious legal questions that distinguish her situation from initial denials of coverage. Mulligan discusses a current groundbreaking case moving through BC courts that might provide a legal pathway forward, exploring potential arguments around negligence, Charter rights regarding cruel and unusual treatment, and judicial review of administrative decisions.
What emerges from this discussion is a sobering reality: when politicians claim they "shouldn't interfere with medical decisions," they're being disingenuous. The system is explicitly designed to make politicians the final arbiters of these treatments after doctors make their recommendations. The criteria for deciding which children receive life-saving medications are, at their core, about money, raising profound questions about how we value human life in our healthcare system. Listen in and consider what changes might be needed to create a more just approach to rare disease treatment in Canada.
Follow this link for a transcript of the show and links to the cases and legislation discussed.
It's time for our regular segment, joined as always by barrister and solicitor with Mulligan Defence Lawyers. It's Legally Speaking on CFAX 1070 with Michael Mulligan. Good afternoon, michael. Thanks so much for the time, as always.
Michael Mulligan:Hey, good afternoon. Thanks so much for having me. It's always great to be here.
Adam Stirling:I know that you've been monitoring some of the discussions that we've been having this week about the case of nine-year-old Charleigh Pollock in Langford.
Michael Mulligan:And I'm curious just off the bat about what you think about what you've been hearing. Well, it's extremely tragic, the circumstance, and it did cause me to do some reading about what the law is in this area to see whether there might be some remedy available there. And it's a fascinating state of affairs in terms of how that works in BC and elsewhere in Canada, in terms of how that works in BC and elsewhere in Canada in terms of coverage for drugs and particularly drugs for rare diseases. And to understand what's going on here. The place to start is in BC. We have a thing that's the Pharmaceutical Services Act and it's an act that provides for government funding of medication in some circumstances. Now, the interesting thing about this in Canada is many people think, oh, don't we have like a national health plan? Isn't there just coverage for everything if you get sick? And you might think that In fact, federally we have a thing called the Canada Health Act and the Canada Health Act indicates that all services provided in hospitals must be insured, and that's one of the sort of principal tenets of that act, and the idea is that the federal government provides money to provinces, but they have to do that.
Michael Mulligan:Now what does that mean Services provided by hospitals. Well, that would be pretty meaningless if they said well, yes, we'll take your appendix out, but sorry, you've got a. We need $500 for the anesthetic right. What kind of coverage is that? And so we've got in BC this Pharmaceutical Services Act, which provides that the provincial government pays for medications in some circumstances. Now the province tries to limit how much they have to pay for medications by saying that the province is the insurer of last resort, and the idea there is that if somebody had private insurance for drugs prescription drugs they want the private insurance company to pay. And if that's not a possible funding source, then the Pharmaceutical Services Act provides that the province will pay for drugs that are listed in a formulary, and that's sort of a list of drugs that are pre-approved that the province would pay for.
Michael Mulligan:How does a drug wind up on that, you might ask? Well, in fact there's a process for that and the province has established this thing called a Drug Benefits Council. And really the reason we have that and these other things which amount to a rationing of health services right, is that when we started to have public health insurance, sort of back in the 60s, the availability of what could be done was much more basic than what could be done now. Right, yeah, they could put a cast on you and help somebody who's having a baby or something, but we could do much more than that now. And so, really, this legislation, this process, is a function of financial rationing, and so the province has created this Drug Benefits Council. That council has 12 members, nine professionals with experience in medicine, ethics interestingly, pharma, economics, health economics and then three members of the public, and that Drug Benefit Council would review potential drugs to determine whether they're going to be put on this formulary, like this list of things that the province might pay for. That council doesn't actually decide, though they make a recommendation and the decision ultimately, at the end of the day, is a pharmacare decision, which is really a political decision, and considerations there include available evidence, public input and estimated cost. And the final consideration in the list of things the province considers when deciding whether to include a drug or not on that formulary is whether coverage for the drug can be accommodated under the current pharmacare budget. And so ultimately, it's a financial decision. And so, even though the Drug Benefit Council might say, yes, this is extremely effective and ethics would say we should provide it, and you know everyone says this is a good idea. The political decision can be simply no, for nothing but economic reasons. Now, for some drugs and that's what sort of general like you know the penicillin or the you know the anesthetic for, you're getting your appendix out. That's where that's going to be.
Michael Mulligan:Now, that same piece of legislation, that Pharmaceutical Services Act, has a section, section 6, the heading there is special payments, and what section 6 allows is that and this is important where there is an application made and it has to be an application made by like a practitioner, like a doctor, right application made by like a practitioner, like a doctor, right, asking that there be payment for a drug not listed on that formulary, then in that circumstance so it's going to be something the doctor is saying, yeah, I'm asking for permission to provide this, we need the money for it Then, and only then, it says the minister may authorize payment under this act for all or part of a drug device or substance. And so what that allows is a political decision by the minister to decide whether they are going to provide funding for something that hasn't been on that general formulary, which would then allow doctors to prescribe it without getting that kind of special permission and pursuant to that Section 6, the one that allows special payments to be authorized by the minister, the government has produced a list several pages long of things that are listed as expensive drugs for rare diseases, and there's a whole. They go on and on these various things. There are many of them and the third one on the list is the drug that Charleigh needs and it has there listed what, that is the generic name for it and its approximate cost. In this case for that drug, $844,000. Yeah, that's it. I guess it's a year for a year. So that's the drug and it's on that list. And so this list has been created as a result of looking into these things, determining, yeah, they've got some benefit. These aren't just you know stuff, that's you know some kind of you know Dr Ho treatment or something that might or might not work. There are things which have been looked at and have been determined to have a benefit.
Michael Mulligan:Now, the challenge with many of these things, when you look at, well, what about this particular drug for Batten disease? Right, one of the challenges with it, it's apparent when you look at some of the material that underlies it is because, by the nature of being a rare disease, right, you don't have the sort of large patient group that you might have if you were trying to do things like you know, the randomized control study, you know where you say, well, let's give some to these people and some to not, and see what happens. The different, this and that's right. And so the evidence is much more limited. And with respect to this particular drug, for example, that one of the publications of province relied upon here is it says notes that there's insufficient data to establish discontinuance criteria for that particular drug and for that disease, which is not perhaps surprising, given that there aren't a lot of people that have that disease.
Michael Mulligan:But the disease interestingly the Batten disease it's a genetic disorder and it's the thing you get if you get two copies of a gene that has a particular mutation.
Michael Mulligan:The other interesting thing about that is that there is work also going on with respect to that disease to determine if there's a possible cure for it, and that would be potentially in the form of genetic modification with CRISPR People might have heard of that.
Michael Mulligan:Right, it's the technology that allows for precise modification to genes, dna, and the belief is that that may be possible, and that's another example of where there's some early trials of that for other diseases.
Michael Mulligan:The challenge with those as well is cost right, because in some cases you need to have a medication designed for a particular patient that would target a particular genetic defect, to then have it corrected by, potentially, a custom medication, and so the other thing that's lurking out here behind this discussion now by the minister not to continue paying for the medication for Charleigh is the possibility that there may be a possibility of there being a fix for this problem. They know what causes the condition, they know the gene that's the defective one, and there's technology potentially to correct it, and so that's the overview of how this works. The other thing we can talk about after the break is that there's litigation going on right now involving a different drug in BC for another rare disease, another expensive drug, and so there's some very interesting law developing right now about how these things might be approached from a legal perspective if there isn't a correction on a ethical or political level, which of course, would be the hope, given the very short timing at play here.
Adam Stirling:Fascinating discussion as we learn more about this. Michael Mulligan with Mulligan Defence Lawyers. Legally speaking, We'll turn right after this. How does the system actually work when it comes to funding drugs for rare diseases? Michael Mulligan from Mulligan Defence Lawyers is taking us through the relevant legislation. He's talked about the Drug Review Council and the various expertise that exists on that council, as well as just three members of the public who also provide input on not only drug efficacy but also the economics and the justification of paying for a given medicine in a given situation. But, as Michael explained before the break, it is ultimately a decision that the minister has the power to make on the recommendation of that council. Where were we, Michael?
Michael Mulligan:So where we're at is what can be done if one of these applications made by a doctor right to get continued payment for a drug is denied by the minister, which is the case that Charleigh dealing with right, the minister has said no under that special payments provision, section six of the act. So what can you do about that? Well, there's a case going on right now where exactly that kind of a challenge is being is winding its way through the court system, exactly that kind of a challenge is being is winding its way through the court system. And that case involves another. It's a BC case. It's a case involving a man who has an ultra rare another ultra rare disease, in this case one that affects his kidneys and could result, if not treated, in retinal failure, damage to kidneys and ultimately possible death. And he was admitted to St Paul's Hospital. A doctor applied under that section for special payments for the expensive drug that could help his condition. The minister approved it, but only for one treatment, and then refused to continue to pay for the expensive drug. And that led to the man bringing a challenge and he made several arguments.
Michael Mulligan:And I should say this this is important to know Judges don't have to serve a freewheeling power to go off and do whatever they think might be the right thing. Right. That would be a topsy-turvy world that we probably don't want to live in. But judges do have authority to either grant remedies constitutional remedies, there's also remedies for concepts, including negligence, and there could be remedies to review an administrative decision. And the first thing to be said is that the minister's decision like when the minister in this case said no to Charleigh doctor is that the minister's decision, like when the minister in this case said no to Charleigh doctor, that administrative decision by the minister is one which would be subject to a judicial review, just like other sort of administrative decision-making processes in the government, on the basis of, for example, reasonableness, right and so if you could demonstrate that, for example, there was something just fundamentally wrong or unfair about the decision-making process, there could be a judicial review on that basis. Interestingly, this act provides that a person has no right to make any submissions about it, which is pretty draconian, like about whether something should be considered no right to be heard, but nonetheless there's a possibility of that kind of a judicial review.
Michael Mulligan:The other possibilities these were ones advanced by the man in the case of the ultra-rare disease, kidney disease. He first of all advanced three charter arguments, and the three sections that he referred to or relied upon were Section 7, which is life, liberty and security of the person, section 12, everyone has the right not to be subject to any cruel and unusual treatment or punishment. And 15, which is the equality provision, which prohibits, amongst others, provides for equal protection of various things, including mental or physical disability. Now, one of the challenges with all of those is that generally, the Charter is interpreted in a way to be sort of a bunch of negative rights, like don't do something to me, right, like, for example, cruel and unusual treatment or punishment involves ordinarily, like it's a prohibition on the state doing something to you, not doing something like not failing to help you. You know what I mean. That's one of the distinctions with these constitutional protections, and so that's in part what the province argued in trying to have this man's claim struck out as having no hope of success. Now, there's an interesting element to that in Charleigh case that may distinguish it from this other man's.
Michael Mulligan:This man's case, which is in Charleigh case, they've provided this medication to her for a number of years, which would have an impact on, for example, her cognitive ability and development and so on.
Michael Mulligan:And there would be, in my judgment, a reasonable argument to be made that if you do that for a number of years, right, somebody sort of, otherwise she might have passed away as a result of a terrible seizure or something at a much younger age. Once you start doing that to somebody although it's a pretty grim concept, the idea is, well, now you've got the person sort of they have you know, they've developed, they're older, they have some understanding. If you now say I'm taking that away from you and you're going to have a potentially terrible experience as a result of that, that might be the sort of action that could constitute cruel, unusual treatment or punishment, as opposed to just I've decided not to help you in the first place because it's too expensive, which is a different set of facts. If I say to you I'm just not paying for that, it's different from I've helped you for a number of years.
Michael Mulligan:Now I'm taking it back I'm stopping, so that's a possibility.
Michael Mulligan:With respect to this man and the kidney medication, the final claim he made was a claim premised on negligence and the idea was that the province or the minister was careless in how they decided to not pay pay for the continued treatment. And initially, at the trial stage, the province applied to have this man's claim struck out as having no hope of success. Right, and they argued a whole series of things you can see in the pleadings about that case. Some of them are interesting. One of the things that they pointed to in their argument was well, to get this drug initially he had to sign an authorization, sign, something saying that when he got the one dose that he has no right to continue getting this and saying, well, now he's barred from complaining about it. That was a different circumstance, interestingly, in the case of a child, because you can't have a necessarily a parent wave off somebody's, for example, constitutional rights or other rights, other rights that might accrue to them. So that's a little bit of a difference. In any case for that man. At the trial stage, a chambers judge in the BC Supreme Court agreed with the province and struck out his whole claim saying this has no hope of success. None of these charter things are going to work and found that this negligence claim can't possibly work on the basis that, first of all, there wasn't a sufficient relationship of proximity which is sort of one of the considerations when deciding whether there is an obligation not to be negligent between the province, the minister and the man with the kidney disease. And then the second argument the province made that got traction initially was an argument that that decision not to pay for additional treatment for this man amounted to a quote core policy decision. And there's this concept that if you're making a core policy decision, like you know, we're not going to plow the roads this winter or something that you can't, then make a successful negligence claim on the basis of well, you chose not to plow the roads. You can make a negligence claim if the government says we're plowing the roads and then they do so poorly, right or carelessly. Now, that succeeded initially.
Michael Mulligan:But he appealed to the BC Court of Appeal and the Court of Appeal overturned what the judge said the original chambers judge finding that the negligence claim could in fact does have a possibility of succeeding and found that really the way the man's lawyers had framed the negligence claim was not a claim of negligence as in the doctor did something negligent. It was a claim that, properly interpreted, was that, in applying the process the minister had put in place for deciding whether they were going to pay for the expensive drug, they did that, that negligently, and the Court of Appeal found that yeah, that's a novel argument, but it's not one that has no hope of success. It might well succeed, and so the Court of Appeal overturned the decision from the Chambers judge and said this claim can proceed. The province was so worried about that they sought leave to appeal to the Supreme Court of Canada. You've got to ask permission, you can't just go there. The Supreme Court of Canada told the province no, and so the Court of Appeal decision stands, and so the case now is back. The province has now failed in their effort to get it struck out and it's now proceeding right now through the court system for a determination ultimately about whether the way the minister said no amounted to negligence.
Michael Mulligan:And so this is the context in which Charleigh case has sort of arisen in terms of its legal issue right now, about whether, for example, there could be an argument about were you negligent when you said no to her right. Did you do that properly and carefully? Because the Court of Appeal has said you might well have a duty of care and that that isn't. That part of it isn't necessarily a core policy decision. You've made some core policy decisions, like you've decided to, you know, pass this act and you've decided to create this list of expensive medications that you're not going to automatically approve because of their cost. That's a core policy decision.
Michael Mulligan:You know, if the province came along and just said, nope, if it's not in our budget, we're not paying for it, right, we're only paying for aspirin and penicillin, that's it right, you would have a much tougher road to hoe. But that's not what they've done. They've passed the Act, they've given authority to the minister, they've listed the various drugs. They've included, for example, the ones here, that the only drug currently that treats Batten disease, and so it's not the decision. We're not plowing the road, right, it's, we'll plow the road if the minister decides that they want to plow the road. And so the argument would be if you're negligent or careless when you're deciding whether that road should be plowed or not, you may well have a negligence claim, and so that's the state of the law. Now, all of this is just not to say that this is necessarily the way this particular case should be resolved. Right, it is abundantly clear that the minister has discretion to approve this. It's just a financial decision. That's all. This is right.
Michael Mulligan:It's an application made by the medical practitioner for the drug. The medical evidence about the drug is not as precise as you would have in something which is much more common. The material about it says exactly that. There isn't a clear criteria for when you might or might not want to proceed with this or when you might want to stop it. The doctor's recommending it.
Michael Mulligan:The minister has discretion to do it or not, do it or not, and so the suggestion by the premier the other day that somehow the government shouldn't or politicians shouldn't be interfering with medical decisions was completely disingenuous, because that is exactly how this legislation is designed. It only happens when you've got an application by a doctor, medical practitioner asking for it, and then it's over to the minister doctor, medical practitioner asking for it, and then it's over to the minister and the criteria for deciding these things are, at their core, money, and so that's where we're at. That's the legal test and that's the legal circumstance in which the minister and the government has made the decision to say no, all right, michael Mulligan, with Mulligan Defence Lawyers.
Adam Stirling:We appreciate you giving us the background on all of this, as always. Thanks so much.
Michael Mulligan:Thanks so much. Always great to be here.
Adam Stirling:All right, legally speaking, on CFAX during the second half of our second hour every Thursday. Quick Break News is next.