June 26, 2025 • 21 mins
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.
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Adam Stirling (00:00):
It's time for our regular segment, joined as
(00:01):
always by barrister andsolicitor with Mulligan Defence
Lawyers.
It's Legally Speaking on CFAX1070 with Michael Mulligan.
Good afternoon, michael.
Thanks so much for the time, asalways.
Michael Mulligan (00:11):
Hey, good afternoon.
Thanks so much for having me.
It's always great to be here.
Adam Stirling (00:14):
I know that you've been monitoring some of
the discussions that we've beenhaving this week about the case
of nine-year-old CharleighPollock in Langford.
Michael Mulligan (00:27):
And I'm curious just off the bat about
what you think about what you'vebeen hearing.
Well, it's extremely tragic,the circumstance, and it did
cause me to do some readingabout what the law is in this
area to see whether there mightbe some remedy available there.
And it's a fascinating state ofaffairs in terms of how that
works in BC and elsewhere inCanada, in terms of how that
works in BC and elsewhere inCanada in terms of coverage for
(00:47):
drugs and particularly drugs forrare diseases.
And to understand what's goingon here.
The place to start is in BC.
We have a thing that's thePharmaceutical Services Act and
it's an act that provides forgovernment funding of medication
in some circumstances.
Now, the interesting thingabout this in Canada is many
(01:10):
people think, oh, don't we havelike a national health plan?
Isn't there just coverage foreverything if you get sick?
And you might think that Infact, federally we have a thing
called the Canada Health Act andthe Canada Health Act indicates
that all services provided inhospitals must be insured, and
that's one of the sort ofprincipal tenets of that act,
and the idea is that the federalgovernment provides money to
(01:33):
provinces, but they have to dothat.
Now what does that mean Servicesprovided by hospitals.
Well, that would be prettymeaningless if they said well,
yes, we'll take your appendixout, but sorry, you've got a.
We need $500 for the anestheticright.
What kind of coverage is that?
And so we've got in BC thisPharmaceutical Services Act,
(01:54):
which provides that theprovincial government pays for
medications in somecircumstances.
Now the province tries to limithow much they have to pay for
medications by saying that theprovince is the insurer of last
resort, and the idea there isthat if somebody had private
insurance for drugs prescriptiondrugs they want the private
(02:18):
insurance company to pay.
And if that's not a possiblefunding source, then the
Pharmaceutical Services Actprovides that the province will
pay for drugs that are listed ina formulary, and that's sort of
a list of drugs that arepre-approved that the province
would pay for.
How does a drug wind up on that,you might ask?
(02:38):
Well, in fact there's a processfor that and the province has
established this thing called aDrug Benefits Council.
And really the reason we havethat and these other things
which amount to a rationing ofhealth services right, is that
when we started to have publichealth insurance, sort of back
(02:58):
in the 60s, the availability ofwhat could be done was much more
basic than what could be donenow.
Right, yeah, they could put acast on you and help somebody
who's having a baby or something, but we could do much more than
that now.
And so, really, thislegislation, this process, is a
function of financial rationing,and so the province has created
(03:20):
this Drug Benefits Council.
That council has 12 members,nine professionals with
experience in medicine, ethicsinterestingly, pharma, economics
, health economics and thenthree members of the public, and
that Drug Benefit Council wouldreview potential drugs to
determine whether they're goingto be put on this formulary,
(03:42):
like this list of things thatthe province might pay for.
That council doesn't actuallydecide, though they make a
recommendation and the decisionultimately, at the end of the
day, is a pharmacare decision,which is really a political
decision, and considerationsthere include available evidence
, public input and estimatedcost.
And the final consideration inthe list of things the province
(04:07):
considers when deciding whetherto include a drug or not on that
formulary is whether coveragefor the drug can be accommodated
under the current pharmacarebudget.
And so ultimately, it's afinancial decision.
And so, even though the DrugBenefit Council might say, yes,
this is extremely effective andethics would say we should
provide it, and you knoweveryone says this is a good
idea.
The political decision can besimply no, for nothing but
(04:29):
economic reasons.
Now, for some drugs and that'swhat sort of general like you
know the penicillin or the youknow the anesthetic for, you're
getting your appendix out.
That's where that's going to be.
Now, that same piece oflegislation, that Pharmaceutical
Services Act, has a section,section 6, the heading there is
special payments, and whatsection 6 allows is that and
(04:54):
this is important where there isan application made and it has
to be an application made bylike a practitioner, like a
doctor, right application madeby like a practitioner, like a
doctor, right, asking that therebe payment for a drug not
listed on that formulary, thenin that circumstance so it's
going to be something the doctoris saying, yeah, I'm asking for
(05:16):
permission to provide this, weneed the money for it Then, and
only then, it says the ministermay authorize payment under this
act for all or part of a drugdevice or substance.
And so what that allows is apolitical decision by the
minister to decide whether theyare going to provide funding for
(05:37):
something that hasn't been onthat general formulary, which
would then allow doctors toprescribe it without getting
that kind of special permissionand pursuant to that Section 6,
the one that allows specialpayments to be authorized by the
minister, the government hasproduced a list several pages
long of things that are listedas expensive drugs for rare
(05:59):
diseases, and there's a whole.
They go on and on these variousthings.
There are many of them and thethird one on the list is the
drug that Charleigh needs and ithas there listed what, that is
the generic name for it and itsapproximate cost.
In this case for that drug,$844,000.
Yeah, that's it.
(06:20):
I guess it's a year for a year.
So that's the drug and it's onthat list.
And so this list has beencreated as a result of looking
into these things, determining,yeah, they've got some benefit.
These aren't just you knowstuff, that's you know some kind
of you know Dr Ho treatment orsomething that might or might
not work.
There are things which havebeen looked at and have been
(06:42):
determined to have a benefit.
Now, the challenge with many ofthese things, when you look at,
well, what about this particulardrug for Batten disease?
Right, one of the challengeswith it, it's apparent when you
look at some of the materialthat underlies it is because, by
the nature of being a raredisease, right, you don't have
the sort of large patient groupthat you might have if you were
trying to do things like youknow, the randomized control
(07:05):
study, you know where you say,well, let's give some to these
people and some to not, and seewhat happens.
The different, this and that'sright.
And so the evidence is muchmore limited.
And with respect to thisparticular drug, for example,
that one of the publications ofprovince relied upon here is it
says notes that there'sinsufficient data to establish
discontinuance criteria for thatparticular drug and for that
(07:26):
disease, which is not perhapssurprising, given that there
aren't a lot of people that havethat disease.
But the disease interestinglythe Batten disease it's a
genetic disorder and it's thething you get if you get two
copies of a gene that has aparticular mutation.
The other interesting thingabout that is that there is work
also going on with respect tothat disease to determine if
(07:47):
there's a possible cure for it,and that would be potentially in
the form of geneticmodification with CRISPR People
might have heard of that.
Right, it's the technology thatallows for precise modification
to genes, dna, and the belief isthat that may be possible, and
that's another example of wherethere's some early trials of
that for other diseases.
(08:08):
The challenge with those as wellis cost right, because in some
cases you need to have amedication designed for a
particular patient that wouldtarget a particular genetic
defect, to then have itcorrected by, potentially, a
custom medication, and so theother thing that's lurking out
here behind this discussion nowby the minister not to continue
(08:30):
paying for the medication forCharleigh is the possibility
that there may be a possibilityof there being a fix for this
problem.
They know what causes thecondition, they know the gene
that's the defective one, andthere's technology potentially
to correct it, and so that's theoverview of how this works.
(08:54):
The other thing we can talkabout after the break is that
there's litigation going onright now involving a different
drug in BC for another raredisease, another expensive drug,
and so there's some veryinteresting law developing right
now about how these thingsmight be approached from a legal
perspective if there isn't acorrection on a ethical or
(09:18):
political level, which of course, would be the hope, given the
very short timing at play here.
Adam Stirling (09:24):
Fascinating discussion as we learn more
about this.
Michael Mulligan with MulliganDefence Lawyers.
Legally speaking, We'll turnright after this.
How does the system actuallywork when it comes to funding
drugs for rare diseases?
Michael Mulligan from MulliganDefence Lawyers is taking us
through the relevant legislation.
He's talked about the DrugReview Council and the various
expertise that exists on thatcouncil, as well as just three
(09:45):
members of the public who alsoprovide input on not only drug
efficacy but also the economicsand the justification of paying
for a given medicine in a givensituation.
But, as Michael explainedbefore the break, it is
ultimately a decision that theminister has the power to make
on the recommendation of thatcouncil.
Where were we, Michael?
Michael Mulligan (10:06):
So where we're at is what can be done if one
of these applications made by adoctor right to get continued
payment for a drug is denied bythe minister, which is the case
that Charleigh dealing withright, the minister has said no
under that special paymentsprovision, section six of the
act.
So what can you do about that?
(10:27):
Well, there's a case going onright now where exactly that
kind of a challenge is being iswinding its way through the
court system, exactly that kindof a challenge is being is
winding its way through thecourt system.
And that case involves another.
It's a BC case.
It's a case involving a man whohas an ultra rare another ultra
(10:51):
rare disease, in this case onethat affects his kidneys and
could result, if not treated, inretinal failure, damage to
kidneys and ultimately possibledeath.
And he was admitted to StPaul's Hospital.
A doctor applied under thatsection for special payments for
the expensive drug that couldhelp his condition.
The minister approved it, butonly for one treatment, and then
(11:14):
refused to continue to pay forthe expensive drug.
And that led to the manbringing a challenge and he made
several arguments.
And I should say this this isimportant to know Judges don't
have to serve a freewheelingpower to go off and do whatever
they think might be the rightthing.
Right.
That would be a topsy-turvyworld that we probably don't
(11:35):
want to live in.
But judges do have authority toeither grant remedies
constitutional remedies, there'salso remedies for concepts,
including negligence, and therecould be remedies to review an
administrative decision.
And the first thing to be saidis that the minister's decision
like when the minister in thiscase said no to Charleigh doctor
(11:56):
is that the minister's decision, like when the minister in this
case said no to Charleighdoctor, that administrative
decision by the minister is onewhich would be subject to a
judicial review, just like othersort of administrative
decision-making processes in thegovernment, on the basis of,
for example, reasonableness,right and so if you could
demonstrate that, for example,there was something just
(12:16):
fundamentally wrong or unfairabout the decision-making
process, there could be ajudicial review on that basis.
Interestingly, this actprovides that a person has no
right to make any submissionsabout it, which is pretty
draconian, like about whethersomething should be considered
no right to be heard, butnonetheless there's a
(12:37):
possibility of that kind of ajudicial review.
The other possibilities thesewere ones advanced by the man in
the case of the ultra-raredisease, kidney disease.
He first of all advanced threecharter arguments, and the three
sections that he referred to orrelied upon were Section 7,
which is life, liberty andsecurity of the person, section
(12:58):
12, everyone has the right notto be subject to any cruel and
unusual treatment or punishment.
And 15, which is the equalityprovision, which prohibits,
amongst others, provides forequal protection of various
things, including mental orphysical disability.
Now, one of the challenges withall of those is that generally,
(13:20):
the Charter is interpreted in away to be sort of a bunch of
negative rights, like don't dosomething to me, right, like,
for example, cruel and unusualtreatment or punishment involves
ordinarily, like it's aprohibition on the state doing
something to you, not doingsomething like not failing to
help you.
You know what I mean.
That's one of the distinctionswith these constitutional
(13:40):
protections, and so that's inpart what the province argued in
trying to have this man's claimstruck out as having no hope of
success.
Now, there's an interestingelement to that in Charleigh
case that may distinguish itfrom this other man's.
This man's case, which is inCharleigh case, they've provided
this medication to her for anumber of years, which would
(14:03):
have an impact on, for example,her cognitive ability and
development and so on.
And there would be, in myjudgment, a reasonable argument
to be made that if you do thatfor a number of years, right,
somebody sort of, otherwise shemight have passed away as a
result of a terrible seizure orsomething at a much younger age.
Once you start doing that tosomebody although it's a pretty
grim concept, the idea is, well,now you've got the person sort
(14:26):
of they have you know, they'vedeveloped, they're older, they
have some understanding.
If you now say I'm taking thataway from you and you're going
to have a potentially terribleexperience as a result of that,
that might be the sort of actionthat could constitute cruel,
unusual treatment or punishment,as opposed to just I've decided
not to help you in the firstplace because it's too expensive
(14:48):
, which is a different set offacts.
If I say to you I'm just notpaying for that, it's different
from I've helped you for anumber of years.
Now I'm taking it back I'mstopping, so that's a
possibility.
With respect to this man and thekidney medication, the final
claim he made was a claimpremised on negligence and the
(15:09):
idea was that the province orthe minister was careless in how
they decided to not pay pay forthe continued treatment.
And initially, at the trialstage, the province applied to
have this man's claim struck outas having no hope of success.
(15:30):
Right, and they argued a wholeseries of things you can see in
the pleadings about that case.
Some of them are interesting.
One of the things that theypointed to in their argument was
well, to get this druginitially he had to sign an
authorization, sign, somethingsaying that when he got the one
dose that he has no right tocontinue getting this and saying
, well, now he's barred fromcomplaining about it.
That was a differentcircumstance, interestingly, in
(15:53):
the case of a child, because youcan't have a necessarily a
parent wave off somebody's, forexample, constitutional rights
or other rights, other rightsthat might accrue to them.
So that's a little bit of adifference.
In any case for that man.
At the trial stage, a chambersjudge in the BC Supreme Court
agreed with the province andstruck out his whole claim
(16:14):
saying this has no hope ofsuccess.
None of these charter thingsare going to work and found that
this negligence claim can'tpossibly work on the basis that,
first of all, there wasn't asufficient relationship of
proximity which is sort of oneof the considerations when
deciding whether there is anobligation not to be negligent
between the province, theminister and the man with the
(16:34):
kidney disease.
And then the second argumentthe province made that got
traction initially was anargument that that decision not
to pay for additional treatmentfor this man amounted to a quote
core policy decision.
And there's this concept thatif you're making a core policy
decision, like you know, we'renot going to plow the roads this
winter or something that youcan't, then make a successful
(16:58):
negligence claim on the basis ofwell, you chose not to plow the
roads.
You can make a negligence claimif the government says we're
plowing the roads and then theydo so poorly, right or
carelessly.
Now, that succeeded initially.
But he appealed to the BC Courtof Appeal and the Court of
Appeal overturned what the judgesaid the original chambers
(17:21):
judge finding that thenegligence claim could in fact
does have a possibility ofsucceeding and found that really
the way the man's lawyers hadframed the negligence claim was
not a claim of negligence as inthe doctor did something
negligent.
It was a claim that, properlyinterpreted, was that, in
(17:41):
applying the process theminister had put in place for
deciding whether they were goingto pay for the expensive drug,
they did that, that negligently,and the Court of Appeal found
that yeah, that's a novelargument, but it's not one that
has no hope of success.
It might well succeed, and sothe Court of Appeal overturned
(18:05):
the decision from the Chambersjudge and said this claim can
proceed.
The province was so worriedabout that they sought leave to
appeal to the Supreme Court ofCanada.
You've got to ask permission,you can't just go there.
The Supreme Court of Canadatold the province no, and so the
Court of Appeal decision stands, and so the case now is back.
(18:27):
The province has now failed intheir effort to get it struck
out and it's now proceedingright now through the court
system for a determinationultimately about whether the way
the minister said no amountedto negligence.
And so this is the context inwhich Charleigh case has sort of
(18:49):
arisen in terms of its legalissue right now, about whether,
for example, there could be anargument about were you
negligent when you said no toher right.
Did you do that properly andcarefully?
Because the Court of Appeal hassaid you might well have a duty
of care and that that isn't.
That part of it isn'tnecessarily a core policy
(19:11):
decision.
You've made some core policydecisions, like you've decided
to, you know, pass this act andyou've decided to create this
list of expensive medicationsthat you're not going to
automatically approve because oftheir cost.
That's a core policy decision.
You know, if the province camealong and just said, nope, if
it's not in our budget, we'renot paying for it, right, we're
(19:33):
only paying for aspirin andpenicillin, that's it right, you
would have a much tougher roadto hoe.
But that's not what they'vedone.
They've passed the Act, they'vegiven authority to the minister
, they've listed the variousdrugs.
They've included, for example,the ones here, that the only
drug currently that treatsBatten disease, and so it's not
(19:56):
the decision.
We're not plowing the road,right, it's, we'll plow the road
if the minister decides thatthey want to plow the road.
And so the argument would be ifyou're negligent or careless
when you're deciding whetherthat road should be plowed or
not, you may well have anegligence claim, and so that's
the state of the law.
(20:16):
Now, all of this is just not tosay that this is necessarily
the way this particular caseshould be resolved.
Right, it is abundantly clearthat the minister has discretion
to approve this.
It's just a financial decision.
That's all.
This is right.
It's an application made by themedical practitioner for the
(20:36):
drug.
The medical evidence about thedrug is not as precise as you
would have in something which ismuch more common.
The material about it saysexactly that.
There isn't a clear criteriafor when you might or might not
want to proceed with this orwhen you might want to stop it.
The doctor's recommending it.
(20:57):
The minister has discretion todo it or not, do it or not, and
so the suggestion by the premierthe other day that somehow the
government shouldn't orpoliticians shouldn't be
interfering with medicaldecisions was completely
disingenuous, because that isexactly how this legislation is
designed.
It only happens when you've gotan application by a doctor,
(21:17):
medical practitioner asking forit, and then it's over to the
minister doctor, medicalpractitioner asking for it, and
then it's over to the ministerand the criteria for deciding
these things are, at their core,money, and so that's where
we're at.
That's the legal test andthat's the legal circumstance in
which the minister and thegovernment has made the decision
(21:38):
to say no, all right, michaelMulligan, with Mulligan Defence
Lawyers.
Adam Stirling (21:41):
We appreciate you giving us the background on all
of this, as always.
Thanks so much.
Michael Mulligan (21:45):
Thanks so much .
Always great to be here.
Adam Stirling (21:47):
All right, legally speaking, on CFAX during
the second half of our secondhour every Thursday.
Quick Break News is next.
It's time for our regular segment, joined as
(00:01):
always by barrister andsolicitor with Mulligan Defence
Lawyers.
It's Legally Speaking on CFAX1070 with Michael Mulligan.
Good afternoon, michael.
Thanks so much for the time, asalways.
Michael Mulligan (00:11):
Hey, good afternoon.
Thanks so much for having me.
It's always great to be here.
Adam Stirling (00:14):
I know that you've been monitoring some of
the discussions that we've beenhaving this week about the case
of nine-year-old CharleighPollock in Langford.
Michael Mulligan (00:27):
And I'm curious just off the bat about
what you think about what you'vebeen hearing.
Well, it's extremely tragic,the circumstance, and it did
cause me to do some readingabout what the law is in this
area to see whether there mightbe some remedy available there.
And it's a fascinating state ofaffairs in terms of how that
works in BC and elsewhere inCanada, in terms of how that
works in BC and elsewhere inCanada in terms of coverage for
(00:47):
drugs and particularly drugs forrare diseases.
And to understand what's goingon here.
The place to start is in BC.
We have a thing that's thePharmaceutical Services Act and
it's an act that provides forgovernment funding of medication
in some circumstances.
Now, the interesting thingabout this in Canada is many
(01:10):
people think, oh, don't we havelike a national health plan?
Isn't there just coverage foreverything if you get sick?
And you might think that Infact, federally we have a thing
called the Canada Health Act andthe Canada Health Act indicates
that all services provided inhospitals must be insured, and
that's one of the sort ofprincipal tenets of that act,
and the idea is that the federalgovernment provides money to
(01:33):
provinces, but they have to dothat.
Now what does that mean Servicesprovided by hospitals.
Well, that would be prettymeaningless if they said well,
yes, we'll take your appendixout, but sorry, you've got a.
We need $500 for the anestheticright.
What kind of coverage is that?
And so we've got in BC thisPharmaceutical Services Act,
(01:54):
which provides that theprovincial government pays for
medications in somecircumstances.
Now the province tries to limithow much they have to pay for
medications by saying that theprovince is the insurer of last
resort, and the idea there isthat if somebody had private
insurance for drugs prescriptiondrugs they want the private
(02:18):
insurance company to pay.
And if that's not a possiblefunding source, then the
Pharmaceutical Services Actprovides that the province will
pay for drugs that are listed ina formulary, and that's sort of
a list of drugs that arepre-approved that the province
would pay for.
How does a drug wind up on that,you might ask?
(02:38):
Well, in fact there's a processfor that and the province has
established this thing called aDrug Benefits Council.
And really the reason we havethat and these other things
which amount to a rationing ofhealth services right, is that
when we started to have publichealth insurance, sort of back
(02:58):
in the 60s, the availability ofwhat could be done was much more
basic than what could be donenow.
Right, yeah, they could put acast on you and help somebody
who's having a baby or something, but we could do much more than
that now.
And so, really, thislegislation, this process, is a
function of financial rationing,and so the province has created
(03:20):
this Drug Benefits Council.
That council has 12 members,nine professionals with
experience in medicine, ethicsinterestingly, pharma, economics
, health economics and thenthree members of the public, and
that Drug Benefit Council wouldreview potential drugs to
determine whether they're goingto be put on this formulary,
(03:42):
like this list of things thatthe province might pay for.
That council doesn't actuallydecide, though they make a
recommendation and the decisionultimately, at the end of the
day, is a pharmacare decision,which is really a political
decision, and considerationsthere include available evidence
, public input and estimatedcost.
And the final consideration inthe list of things the province
(04:07):
considers when deciding whetherto include a drug or not on that
formulary is whether coveragefor the drug can be accommodated
under the current pharmacarebudget.
And so ultimately, it's afinancial decision.
And so, even though the DrugBenefit Council might say, yes,
this is extremely effective andethics would say we should
provide it, and you knoweveryone says this is a good
idea.
The political decision can besimply no, for nothing but
(04:29):
economic reasons.
Now, for some drugs and that'swhat sort of general like you
know the penicillin or the youknow the anesthetic for, you're
getting your appendix out.
That's where that's going to be.
Now, that same piece oflegislation, that Pharmaceutical
Services Act, has a section,section 6, the heading there is
special payments, and whatsection 6 allows is that and
(04:54):
this is important where there isan application made and it has
to be an application made bylike a practitioner, like a
doctor, right application madeby like a practitioner, like a
doctor, right, asking that therebe payment for a drug not
listed on that formulary, thenin that circumstance so it's
going to be something the doctoris saying, yeah, I'm asking for
(05:16):
permission to provide this, weneed the money for it Then, and
only then, it says the ministermay authorize payment under this
act for all or part of a drugdevice or substance.
And so what that allows is apolitical decision by the
minister to decide whether theyare going to provide funding for
(05:37):
something that hasn't been onthat general formulary, which
would then allow doctors toprescribe it without getting
that kind of special permissionand pursuant to that Section 6,
the one that allows specialpayments to be authorized by the
minister, the government hasproduced a list several pages
long of things that are listedas expensive drugs for rare
(05:59):
diseases, and there's a whole.
They go on and on these variousthings.
There are many of them and thethird one on the list is the
drug that Charleigh needs and ithas there listed what, that is
the generic name for it and itsapproximate cost.
In this case for that drug,$844,000.
Yeah, that's it.
(06:20):
I guess it's a year for a year.
So that's the drug and it's onthat list.
And so this list has beencreated as a result of looking
into these things, determining,yeah, they've got some benefit.
These aren't just you knowstuff, that's you know some kind
of you know Dr Ho treatment orsomething that might or might
not work.
There are things which havebeen looked at and have been
(06:42):
determined to have a benefit.
Now, the challenge with many ofthese things, when you look at,
well, what about this particulardrug for Batten disease?
Right, one of the challengeswith it, it's apparent when you
look at some of the materialthat underlies it is because, by
the nature of being a raredisease, right, you don't have
the sort of large patient groupthat you might have if you were
trying to do things like youknow, the randomized control
(07:05):
study, you know where you say,well, let's give some to these
people and some to not, and seewhat happens.
The different, this and that'sright.
And so the evidence is muchmore limited.
And with respect to thisparticular drug, for example,
that one of the publications ofprovince relied upon here is it
says notes that there'sinsufficient data to establish
discontinuance criteria for thatparticular drug and for that
(07:26):
disease, which is not perhapssurprising, given that there
aren't a lot of people that havethat disease.
But the disease interestinglythe Batten disease it's a
genetic disorder and it's thething you get if you get two
copies of a gene that has aparticular mutation.
The other interesting thingabout that is that there is work
also going on with respect tothat disease to determine if
(07:47):
there's a possible cure for it,and that would be potentially in
the form of geneticmodification with CRISPR People
might have heard of that.
Right, it's the technology thatallows for precise modification
to genes, dna, and the belief isthat that may be possible, and
that's another example of wherethere's some early trials of
that for other diseases.
(08:08):
The challenge with those as wellis cost right, because in some
cases you need to have amedication designed for a
particular patient that wouldtarget a particular genetic
defect, to then have itcorrected by, potentially, a
custom medication, and so theother thing that's lurking out
here behind this discussion nowby the minister not to continue
(08:30):
paying for the medication forCharleigh is the possibility
that there may be a possibilityof there being a fix for this
problem.
They know what causes thecondition, they know the gene
that's the defective one, andthere's technology potentially
to correct it, and so that's theoverview of how this works.
(08:54):
The other thing we can talkabout after the break is that
there's litigation going onright now involving a different
drug in BC for another raredisease, another expensive drug,
and so there's some veryinteresting law developing right
now about how these thingsmight be approached from a legal
perspective if there isn't acorrection on a ethical or
(09:18):
political level, which of course, would be the hope, given the
very short timing at play here.
Adam Stirling (09:24):
Fascinating discussion as we learn more
about this.
Michael Mulligan with MulliganDefence Lawyers.
Legally speaking, We'll turnright after this.
How does the system actuallywork when it comes to funding
drugs for rare diseases?
Michael Mulligan from MulliganDefence Lawyers is taking us
through the relevant legislation.
He's talked about the DrugReview Council and the various
expertise that exists on thatcouncil, as well as just three
(09:45):
members of the public who alsoprovide input on not only drug
efficacy but also the economicsand the justification of paying
for a given medicine in a givensituation.
But, as Michael explainedbefore the break, it is
ultimately a decision that theminister has the power to make
on the recommendation of thatcouncil.
Where were we, Michael?
Michael Mulligan (10:06):
So where we're at is what can be done if one
of these applications made by adoctor right to get continued
payment for a drug is denied bythe minister, which is the case
that Charleigh dealing withright, the minister has said no
under that special paymentsprovision, section six of the
act.
So what can you do about that?
(10:27):
Well, there's a case going onright now where exactly that
kind of a challenge is being iswinding its way through the
court system, exactly that kindof a challenge is being is
winding its way through thecourt system.
And that case involves another.
It's a BC case.
It's a case involving a man whohas an ultra rare another ultra
(10:51):
rare disease, in this case onethat affects his kidneys and
could result, if not treated, inretinal failure, damage to
kidneys and ultimately possibledeath.
And he was admitted to StPaul's Hospital.
A doctor applied under thatsection for special payments for
the expensive drug that couldhelp his condition.
The minister approved it, butonly for one treatment, and then
(11:14):
refused to continue to pay forthe expensive drug.
And that led to the manbringing a challenge and he made
several arguments.
And I should say this this isimportant to know Judges don't
have to serve a freewheelingpower to go off and do whatever
they think might be the rightthing.
Right.
That would be a topsy-turvyworld that we probably don't
(11:35):
want to live in.
But judges do have authority toeither grant remedies
constitutional remedies, there'salso remedies for concepts,
including negligence, and therecould be remedies to review an
administrative decision.
And the first thing to be saidis that the minister's decision
like when the minister in thiscase said no to Charleigh doctor
(11:56):
is that the minister's decision, like when the minister in this
case said no to Charleighdoctor, that administrative
decision by the minister is onewhich would be subject to a
judicial review, just like othersort of administrative
decision-making processes in thegovernment, on the basis of,
for example, reasonableness,right and so if you could
demonstrate that, for example,there was something just
(12:16):
fundamentally wrong or unfairabout the decision-making
process, there could be ajudicial review on that basis.
Interestingly, this actprovides that a person has no
right to make any submissionsabout it, which is pretty
draconian, like about whethersomething should be considered
no right to be heard, butnonetheless there's a
(12:37):
possibility of that kind of ajudicial review.
The other possibilities thesewere ones advanced by the man in
the case of the ultra-raredisease, kidney disease.
He first of all advanced threecharter arguments, and the three
sections that he referred to orrelied upon were Section 7,
which is life, liberty andsecurity of the person, section
(12:58):
12, everyone has the right notto be subject to any cruel and
unusual treatment or punishment.
And 15, which is the equalityprovision, which prohibits,
amongst others, provides forequal protection of various
things, including mental orphysical disability.
Now, one of the challenges withall of those is that generally,
(13:20):
the Charter is interpreted in away to be sort of a bunch of
negative rights, like don't dosomething to me, right, like,
for example, cruel and unusualtreatment or punishment involves
ordinarily, like it's aprohibition on the state doing
something to you, not doingsomething like not failing to
help you.
You know what I mean.
That's one of the distinctionswith these constitutional
(13:40):
protections, and so that's inpart what the province argued in
trying to have this man's claimstruck out as having no hope of
success.
Now, there's an interestingelement to that in Charleigh
case that may distinguish itfrom this other man's.
This man's case, which is inCharleigh case, they've provided
this medication to her for anumber of years, which would
(14:03):
have an impact on, for example,her cognitive ability and
development and so on.
And there would be, in myjudgment, a reasonable argument
to be made that if you do thatfor a number of years, right,
somebody sort of, otherwise shemight have passed away as a
result of a terrible seizure orsomething at a much younger age.
Once you start doing that tosomebody although it's a pretty
grim concept, the idea is, well,now you've got the person sort
(14:26):
of they have you know, they'vedeveloped, they're older, they
have some understanding.
If you now say I'm taking thataway from you and you're going
to have a potentially terribleexperience as a result of that,
that might be the sort of actionthat could constitute cruel,
unusual treatment or punishment,as opposed to just I've decided
not to help you in the firstplace because it's too expensive
(14:48):
, which is a different set offacts.
If I say to you I'm just notpaying for that, it's different
from I've helped you for anumber of years.
Now I'm taking it back I'mstopping, so that's a
possibility.
With respect to this man and thekidney medication, the final
claim he made was a claimpremised on negligence and the
(15:09):
idea was that the province orthe minister was careless in how
they decided to not pay pay forthe continued treatment.
And initially, at the trialstage, the province applied to
have this man's claim struck outas having no hope of success.
(15:30):
Right, and they argued a wholeseries of things you can see in
the pleadings about that case.
Some of them are interesting.
One of the things that theypointed to in their argument was
well, to get this druginitially he had to sign an
authorization, sign, somethingsaying that when he got the one
dose that he has no right tocontinue getting this and saying
, well, now he's barred fromcomplaining about it.
That was a differentcircumstance, interestingly, in
(15:53):
the case of a child, because youcan't have a necessarily a
parent wave off somebody's, forexample, constitutional rights
or other rights, other rightsthat might accrue to them.
So that's a little bit of adifference.
In any case for that man.
At the trial stage, a chambersjudge in the BC Supreme Court
agreed with the province andstruck out his whole claim
(16:14):
saying this has no hope ofsuccess.
None of these charter thingsare going to work and found that
this negligence claim can'tpossibly work on the basis that,
first of all, there wasn't asufficient relationship of
proximity which is sort of oneof the considerations when
deciding whether there is anobligation not to be negligent
between the province, theminister and the man with the
(16:34):
kidney disease.
And then the second argumentthe province made that got
traction initially was anargument that that decision not
to pay for additional treatmentfor this man amounted to a quote
core policy decision.
And there's this concept thatif you're making a core policy
decision, like you know, we'renot going to plow the roads this
winter or something that youcan't, then make a successful
(16:58):
negligence claim on the basis ofwell, you chose not to plow the
roads.
You can make a negligence claimif the government says we're
plowing the roads and then theydo so poorly, right or
carelessly.
Now, that succeeded initially.
But he appealed to the BC Courtof Appeal and the Court of
Appeal overturned what the judgesaid the original chambers
(17:21):
judge finding that thenegligence claim could in fact
does have a possibility ofsucceeding and found that really
the way the man's lawyers hadframed the negligence claim was
not a claim of negligence as inthe doctor did something
negligent.
It was a claim that, properlyinterpreted, was that, in
(17:41):
applying the process theminister had put in place for
deciding whether they were goingto pay for the expensive drug,
they did that, that negligently,and the Court of Appeal found
that yeah, that's a novelargument, but it's not one that
has no hope of success.
It might well succeed, and sothe Court of Appeal overturned
(18:05):
the decision from the Chambersjudge and said this claim can
proceed.
The province was so worriedabout that they sought leave to
appeal to the Supreme Court ofCanada.
You've got to ask permission,you can't just go there.
The Supreme Court of Canadatold the province no, and so the
Court of Appeal decision stands, and so the case now is back.
(18:27):
The province has now failed intheir effort to get it struck
out and it's now proceedingright now through the court
system for a determinationultimately about whether the way
the minister said no amountedto negligence.
And so this is the context inwhich Charleigh case has sort of
(18:49):
arisen in terms of its legalissue right now, about whether,
for example, there could be anargument about were you
negligent when you said no toher right.
Did you do that properly andcarefully?
Because the Court of Appeal hassaid you might well have a duty
of care and that that isn't.
That part of it isn'tnecessarily a core policy
(19:11):
decision.
You've made some core policydecisions, like you've decided
to, you know, pass this act andyou've decided to create this
list of expensive medicationsthat you're not going to
automatically approve because oftheir cost.
That's a core policy decision.
You know, if the province camealong and just said, nope, if
it's not in our budget, we'renot paying for it, right, we're
(19:33):
only paying for aspirin andpenicillin, that's it right, you
would have a much tougher roadto hoe.
But that's not what they'vedone.
They've passed the Act, they'vegiven authority to the minister
, they've listed the variousdrugs.
They've included, for example,the ones here, that the only
drug currently that treatsBatten disease, and so it's not
(19:56):
the decision.
We're not plowing the road,right, it's, we'll plow the road
if the minister decides thatthey want to plow the road.
And so the argument would be ifyou're negligent or careless
when you're deciding whetherthat road should be plowed or
not, you may well have anegligence claim, and so that's
the state of the law.
(20:16):
Now, all of this is just not tosay that this is necessarily
the way this particular caseshould be resolved.
Right, it is abundantly clearthat the minister has discretion
to approve this.
It's just a financial decision.
That's all.
This is right.
It's an application made by themedical practitioner for the
(20:36):
drug.
The medical evidence about thedrug is not as precise as you
would have in something which ismuch more common.
The material about it saysexactly that.
There isn't a clear criteriafor when you might or might not
want to proceed with this orwhen you might want to stop it.
The doctor's recommending it.
(20:57):
The minister has discretion todo it or not, do it or not, and
so the suggestion by the premierthe other day that somehow the
government shouldn't orpoliticians shouldn't be
interfering with medicaldecisions was completely
disingenuous, because that isexactly how this legislation is
designed.
It only happens when you've gotan application by a doctor,
(21:17):
medical practitioner asking forit, and then it's over to the
minister doctor, medicalpractitioner asking for it, and
then it's over to the ministerand the criteria for deciding
these things are, at their core,money, and so that's where
we're at.
That's the legal test andthat's the legal circumstance in
which the minister and thegovernment has made the decision
(21:38):
to say no, all right, michaelMulligan, with Mulligan Defence
Lawyers.
Adam Stirling (21:41):
We appreciate you giving us the background on all
of this, as always.
Thanks so much.
Michael Mulligan (21:45):
Thanks so much .
Always great to be here.
Adam Stirling (21:47):
All right, legally speaking, on CFAX during
the second half of our secondhour every Thursday.
Quick Break News is next.
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