E20 Regulation of Therapeutic Goods and Medical Devices - With Dr Marco Rizzi - The Law Down Under Podcast

Episode Transcript
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Chris Patterson (00:07):
In this episode of the podcast, we discuss the
regulation of therapeutic goodsand medical devices. It's quite
a timely episode because we'restill in the middle of a health
pandemic. How our laws react toand support advances in medical
technology and science iscritically important for the

(00:28):
well being of everyone. I'mreally privileged that I was
joined by an expert in thisarea, and I hope that you'll
enjoy the podcast as well.
Joining me today on the podcastis Dr. Marco Rizzi, who is an
Associate Professor and DeputyHead of the University of

(00:48):
Western Australia's Law School.His research focuses on the
protection of health and safety,and the relationship between
law, politics and the market.Marco has a PhD in Law and a
Master's degree in ComparativeLaw from the European University
Institute in Italy. He has aMaster's degree in Civil Law
from the University of Pisa.Marco has filled many positions

(01:09):
at the University of WesternAustralia, including as a member
of its Human Research EthicsCommittee, an Academic Conduct
Adviser, and a Senior Lecturer.Before that, he worked at the
University of Seychelles. InSeptember 2022, earlier this
year, Marco was awarded aResearch Award for Early Career
Researcher by the University ofWestern Australia's Law School,

(01:32):
and a Commendation Award inResearch Impact Innovation by
the University of WesternAustralia's School for Social
Sciences. Hello, buongiorno, andwelcome Marco.

Marco Rizzi (01:44):
Buongiorno. Thanks for having me.

That's the limit of my Italian. I'm not
going to try and speak any afterthat. I'd just embarrassed
myself terribly. Yeah. How manylanguages can you speak just out
of interest?

So Italian, French, as mother tongues, English, bit
of Spanish, bit of German.

You know, this is the thing. Kiwis and Aussies
are just kind of so limited. Imean, if we're lucky, we've kind
of almost got a conversationalgrasp of English. But beyond
that, there's not much happeningthere. I mean, I've tried very
hard to learn Spanish. And Imean, I can certainly hold a

(02:27):
conversation in espagnol to alimited degree. But that's,
that's the limit. It alwaysimpresses and admires me when
I'm in Europe, and I meetEuropeans, and they can speak,
you know, 5 6 7 languages. It'svery impressive.

Yeah. Well, I mean, it's luck of the draw, where you
were born kind of determinesthat a little bit.

Well, it does. Yeah, it does. But also having,
you know, the interest and thedesire to learn other languages.
I mean, I think it's a great,great thing to do. Anyway, we
get to talk about health law,but in particular, we're going
to talk about law relating totherapeutic products, etcetera.

(03:09):
And one of the first things Iwanted to ask you about with
this, because I'm superinterested in this is, you know,
what is actually a therapeuticgood?

Yeah. Thanks, Chris. Thanks for having me.
Also, thank you for thepromotion. I'm Associate
Professor for the moment, but Icertainly aspire to
professorship one day. In termsof your question, so therapeutic
goods. In Australia, we havethis legislation called the

(03:43):
Therapeutic Goods Act. And thenwe have a Therapeutic Goods
Administration, which is anindependent agency that oversees
the regulation of these goods.So what are they? Essentially,
any product that has an intendedtherapeutic effect, or that is
used for the treatment ordiagnosis, the prevention, the

(04:05):
monitoring of health conditions.And I think what is interesting
about the Australian context isthat it is quite unique in using
a generic like overarchingdefinition. Normally, what you
have is like, for instance, inEurope, you have the European
Medicines Agency. I believe inNew Zealand, you have PHARMAC,

(04:26):
which is also focused onpharmaceuticals prevalently. In
the United States there's theFood and Drug Administration, so
again, like the emphasis ondrugs, although the Food and
Drug Administration also looksat medical devices. What we have
in Australia is an attempt tobasically bring every good that

(04:48):
has this intended therapeuticuse under one big umbrella. And
that is where this term'therapeutic goods' comes from.
What it means, in fact, istherapeutic goods tend to be
medical devices,pharmaceuticals, including
vaccines. So these are the two,the two big families of

(05:09):
therapeutic goods.

Okay. So, like if I go to the Chemist
Warehouse, for example, youknow, obviously anything that
requires a prescription is goingto fit into that sort of
classic, it's a drug, it's fortherapeutic use. But sometimes
the line isn't particularlyclear as to whether something is

(05:33):
being, you know, produced orpromoted for therapeutic use.
Maybe an example is just sprungto mind as you know, late at
night, I'm working to get somesubmissions out that are due the
next day and I'm feeling alittle bit tired. So, you know,
I might I might crack open a canof Red Bull, full of caffeine

(05:54):
and other chemicals. Would thatbe would that fit into the
category of being a therapeuticgood?

Well, I mean, it probably should, but no Red Bull
is not regulated as atherapeutic good. It is, it
probably falls under the morethe lesser category of like
supplements. So, but it is truethat when you walk into Chemist
Warehouse, you are obviously youhave a wide range of choice of

(06:28):
therapeutic goods. So, the mostheavily regulated ones are the
ones you would call prescriptiondrugs, typically. Prescription
drugs are the ones that can onlybe dispensed with a physician's
prescription, whereas you alsohave lots of over the counter
drugs. So for instance,ibuprofen or Panadol, like the

(06:50):
stuff that we you know, usequite frequently aspirin,
etcetera. All of these aretherapeutic goods. They are
regulated. However, they areconsidered to be safe for
consumption without aphysician's direction, okay. So,

(07:14):
basically, what determinesessentially whether a medicine
will be a prescription medicineor over the counter is the
degree of risk that isassociated with consumption. So,
certain drugs, know everypharmaceutical that is there has

(07:34):
ever been produced, carries acertain degree of risk. So, it
is impossible to have drugs ormedicines that are completely
risk free. Now, depending on therisk profile, so, what the
adverse the potential adverseevent is, how frequent the
adverse event may be, thenregulators can make the decision

(07:58):
to make the drug or the medicineprescription only, or over the
counter. Okay, so that's, that'sa little bit how the system
works in a nutshell.

Okay. So do I understand that, you know, as
part of the Therapeutic GoodsAdministration, and the body
that the TGA that'sadministrating it, that they are
undertaking every time there isa therapeutic good, that is, you
know, being produced inAustralia, or being brought into

(08:28):
the country, they're looking atit to say, you know, what's the
risk profile with this product?And then where does that fit in
the categories of, orcategorizing that particular
product? Is that the approachthat's taken?

Yes. So the Therapeutic Goods
Administration, if you lookthere, the legislative framework
that they operate under, theybasically take what's called a
risk based approach toregulation. A risk based
approach to regulation means, soyou can have different types of
approach. There's moreconservative ones like

(09:06):
precautionary. Precautionaryapproach means that essentially,
if there is the potential for,you know, harm, you just take
action, you take preventativeaction, of course, the
precautionary approach to riskin the realm of therapeutic
goods doesn't work. Because ifyou're going to be
precautionary, as a general kindof guiding principle, well,

(09:30):
you're never going to haveinnovation. So, a risk based
approach emphasizes that behindevery decision to authorize
certain products for you know,rollout or consumption in the
market or to allow physicians toprescribe it, there is a an

(09:51):
underpinning cost benefitanalysis essentially. Or risk
utility analysis. And where theTherapeutic Goods, the
regulators are satisfied thatthe benefits outweigh the risk,
they will approve the productfor marketing and for
distribution. Now the mechanismthat is followed, the more

(10:15):
granular mechanism that isfollowed is quite different
depending on the type oftherapeutic goods. So,
pharmaceuticals, includingvaccines follow a certain type
of review. Medical devicesfollow a different type of
review. And then there's theadditional layer of complication
that is whether the product isproduced domestically or

(10:37):
imported. Now, the reality isthat a country like Australia,
and I believe New Zealand issimilar in this sense, does not
have a huge domestic industry.So there's not a whole lot of
production and in development,that product development that

(10:58):
happens domestically, the vastmajority of therapeutic goods
that are distributed inAustralia are imported. So you
need to have parallel kind ofregulatory mechanisms. One is
for what happens when you know,something is produced in house
and a different type of reviewfor a product that has been

(11:22):
produced elsewhere and that isbeing imported.

Okay, so where would like licensed
manufacturing, sit into thatequation? You've got a
pharmaceutical company sittingin, let's just say, in Perth in
Western Australia, and it'sproducing medicines, but under
license from an overseascompany. Where would that sit?

Well, I think, so by licensed, do you mean the
intellectual property regime or?

For example, the patents, so there may be a
therapeutic medicine, that anAustralian company hasn't
developed themselves, so theyhaven't gone through that
developmental pathway inAustralia, but rather, what
they're just simply doing isthey're manufacturing it under
license of which is held by anoverseas pharmaceutical company.

Yeah. So it's important to to keep the two
regimes separate. Sointellectual property, licensing
and all that operates at onelevel and that has, that
basically operates at the levelof guaranteeing intellectual

(12:32):
property rights of developersand manufacturers. So you don't,
and this was particularly thiswas a big thing with the COVID
vaccines, obviously. So the ideais, if you hold the patents, if
you hold intellectual propertyrights over the design of a
certain drug, what you don'twant is others to replicate that

(12:56):
particular therapeutic good,without essentially either
paying you or without, you know,some kind of agreement that
guarantees your intellectualproperty rights. Now, whether
that is whether that isdesirable or not, is one
question. But setting that asidefor a second, what the TGA does
is very different. So regardlessof the intellectual property

(13:19):
regime, if you want to market aproduct, whether or not you hold
the patent, or whether you'reproducing it, you know, your
license to produce somethingthat has been invented by
someone else, you still have toundergo the testing, and you
still have to undergo the reviewby the TGA. So what the TGA
looks at, it's not it hasnothing to do with intellectual

(13:42):
property. It has to do withsafety and efficacy.

So can I just jump in here? Because I want to
be clear on this. Whether ourlocal pharmaceutical company has
developed a product themselves,or they're simply manufacturing
it, a drug that's actually beendeveloped by an overseas
company, it makes no difference.The testing still needs to be

(14:10):
undertaken. Is that is thatcompared to for example, if the
pharmaceutical company was justan importer, like they were just
literally importing thetherapeutic product into
Australia, it makes nodifference.

So okay. That's a good question. So let me break
it down in into digestiblepieces. So what the TGA does is
it authorizes a certain productfor distribution. That has to
happen anyway. Okay, so whetherthe product is imported,

(14:47):
developed domestically, inventeddomestically or produced under
license domestically, thatdoesn't matter. If you want to
distribute like a therapeuticgood, a medicine, it has to be
authorized by the TherapeuticGoods Administration, which
means that the Therapeutic GoodsAdministration needs to be
satisfied that it is both safeand effective. We can talk about

(15:08):
how... But first, let me justexplain it. So there's the
issue, the risk, of course, isthat if you say an American
manufacturer or a Europeanmanufacturer wants to sell their
drugs in Australia, whichhappens all the time, like

(15:30):
actually, the vast majority ofthe drugs that we consume in
Australasia are not designed anddeveloped in Australasia. What
happens is that typically, thetherapeutics administration will
end the sponsor, so the companythat wants to have that product
registered will normally providethe TGA with approvals from

(15:55):
overseas companies. So the TGAwill be aware of the fact that a
certain product has beenapproved, say by the American
Food and Drug Administration, orby the European Medicines
Agency, or the Japaneseregulator, etc. And that can can
speed up the review in a way orit gives at least a starting

(16:16):
point where you can butnevertheless, for medicines in
particular, and this is wherethere is a bit of a divide
between medicines and medicaldevices, medicines, the
therapeutic good, still has toundergo an independent still has
to perform an independentreview. So again, the COVID
vaccines is a good example. SoAustralia approved the COVID

(16:38):
vaccines later than the UnitedStates FDA, the UK MHRA or the
European Medicines Agency, itwas it happened afterwards.

Okay, can I just stop you there Marco? Just
because one thing that you'veraised, which jumps a question
out to me is, to what extent isthe TGA influencedby an
organization like the AmericanFDA, where the American FDA have

(17:13):
certified, you know, atherapeutic, good, or a medicine
as being fit for use? does? Doesthat play a role in any way?
Because it seems to me that,shouldn't we have some
confidence that if the FDA areapproving something, then it

(17:33):
must be safe?

Certainly, regulatory authorities across
the world do not operate in avacuum. So there are networks
and bilateral agreements betweenbetween regulators particularly
so for example, the TGA, the FDAor the European Medicines

(17:58):
Agency, they are there is aconstant, there is a constant
interaction, because the idea isyou what you don't want to do is
you don't want to you don't wantto duplicate efforts, you don't
want to kind of reinvent thewheel at every point in time. So
is there some some level ofinfluence? I would say, more

(18:19):
than the FDA influencing thedecisions of the TGA. It's it is
more the case that the theseregulators all operate in a sort
of coordinated way to an extent,particularly when it comes to
drugs that are globallydistributed. So it does does it
have does it have an influence?Certainly does. Because it does

(18:40):
mean that one regulator has kindof gone through the steps that
are required to be satisfiedthat a certain product is safe
and effective. That does notmean however, that it
automatically translates.Because the regulatory
frameworks aren't exactly thesame. There are levels of risk.

(19:04):
So the United Statestraditionally is a little bit
more risk, has a bit more of apropensity to risk compared to
for example, the European one.So, which is why certainly it
does have it doesn't mean thatyou're not starting from scratch
when another regulator hasalready performed a review, but

(19:28):
you still conduct an independentreview of medical data.

Yeah, I mean, from my perspective, and I know
this is very much a naive one,because it's this isn't my area
of expertise, but more as aconsumer of medicines, and I
mean, I've had three shots ofthe vaccine and getting ready
for my fourth one coming upsoon, is that I did sort of

(19:58):
stand back and think to myselfhave, you know, this pandemic
has created a very unique momentin time where there was an
absolute risk to the health andwell being of the entire planet,
okay, without being overlydramatic, okay. And the miracle

(20:20):
of science was that within ashort period of time, a handful
of the pharmaceutical companiesproduced the vaccine, like,
quite quickly, you know, thisrDNA vaccine, but then it had to
go through regulatory approvalin all the countries it was
going to be rolled out at, youknow, which included Australia
and New Zealand, because thathad to happen before people got

(20:42):
shots in arms. But here I was,sort of in locked down, borders
closed New Zealand, going well,we're really lucky because we,
we've managed to eliminateCOVID. But we cannot, we can't
eliminate it forever. Like wecan't keep our borders closed
and expect that it's not goingto happen. So we need a vaccine

(21:03):
rollout. And we're going to haveit, you know, reasonably
quickly, but there was thisdelay occurring, and it made me
wonder, why are we waiting forlike, why would New Zealand or
even if we take Australia, whywould we think that we've got
smarter people, okay, who canlook at this vaccine, and assess

(21:23):
the risks at a higher level thanthe most powerful economic
nation on the planet that hassome of the brightest medical
minds on the globe, who havegone through it, presumably, and
this is the assumption the FDAhave gone through it with a fine
tooth comb, before they startinjecting 385 million Americans

(21:45):
with it in a country where ifthey get it wrong, the
consequences can be horrific,from a legal point of view,
putting aside the social and thehealth point of view. So why is
it that New Zealand andAustralia feel that we need to
go through and check thesethings? You know, what am I

(22:06):
missing? Yeah.

So that is a small question.

No no, sorry, that went on for quite a while.
I guess, why can't we justrubber stamp. ..You know, if
it's FDA approved, it's fine.Let's all get it in us.

It's a fair point. So okay, let me preface this by
saying the approval of COVIDvaccine that was an emergency
situation. So it's not whatnormally happens, right? So your
normal situation is I don'tknow, you develop a new
antidepressant or a newanticoagulants or a new, I don't
know, anti diabetes drug. And,you know, it takes a certain

(22:44):
amount of time, it takescertain, normally years. And
eventually it gets on themarket. And you can try to have
bilateral agreements torecognize tests, for example,
clinical trials that are, youknow, performed abroad, instead
of having to do them alldomestically. But anyway, to
answer your question about theCOVID vaccines specifically...

Or in fact, any approval. Why couldn't we have a
system where if it's approved bythe FDA, that's fine, you know,
we don't need to go through thisregulatory...

Because not every country has the same thresholds.
And not every country acceptsthe same trade offs between for
example, speediness ofavailability versus safety. Not
every country is perfectlycomparable when it comes to for

(23:44):
instance, the overall regulatorysystem. So you talk about the
FDA. So the FDA is arguably alittle bit more prone to approve
products on a slightly lesserrisk utility evaluation. So the

(24:06):
level of risk that is acceptedis a little bit higher. Part of
this is linked to the fact thatthe United States... If you look
at the overall regulatoryregime, so not just the front
end, the tests that you need toundertake and the hoops you need
to go through before you get theproduct on the market, but you
look at it holistically. So youlook, for instance, at the

(24:29):
remedies available and thecourses of action available, the
United States tends to have anentrepreneurial class of
litigators that put together bigclass actions. Yeah, type of
back end watchdog is a integralparts to the overall regulatory

(24:50):
model, which prompts the ussometimes to make decisions on a
risk utility analysis that isdifferent to the one that for
example, you would have inEurope, where access to courts
and litigation is not at all aseasy as incentivised class
actions aren't really available,for example. And the problem is

(25:13):
with therapeutic goods, youreally need class actions,
because it's very hard for anindividual to say, this
particular product calls me thisparticular harm, it is much
easier to if you aggregate aclass to say look at there's a
pattern of these people have alltaken the drugs under certain
circumstances. And compared tolike, you know, the general

(25:34):
population, the incidence ofsay, heart failure increases by
a certain percentage, therefore,you can make the inference that
the adverse event is linked tothe drug, but you need to
aggregate claims in order to dothat.

Well, it's one of those classic areas where why
class actions work, because anindividual is not going going to
have the resources to be able toassert their rights. And it is
that grouping that enables theclass action regime to work. I
mean, New Zealand doesn't have aclass action regime, it's still

(26:11):
using this ridiculous archaicrepresentative action. But at
least Australia since I think1998 has had at various state
levels, a class action regimethat's worked quite well. I
can't think of where the classaction regime has been applied
against a pharmaceuticalcompany, but there may have been

(26:34):
one. But I'll share a little funfact thought with it with you,
Marco, and that is the greatsunny state of New South Wales
is actually the most litigiousstate on the planet Earth.
Second only, okay, second onlyto California. Okay. So that is
on a per capita basis. That's alittle fun fact. But your points

(26:54):
well made is that the the classaction regime and the lawyers
who are class action lawyers actas a bit of a watchdog to ensure
that these companies are notdoing anything that or hopefully
watching as another layer, thatthese companies aren't producing
products that are going to hurtpeople.

Yeah. So I think that the problem with
therapeutic goods is that,especially with drugs, it's very
rare that a drug will have whatyou call a signature adverse
event. So one example a rareexample of that is the so the
famous AstraZeneca vaccine hadthat very, very, very, very
small chance of causing a very,very particular and a very rare

(27:40):
type of thrombosis, which kindof then sends the entire rollout
out the window, essentially, ofthat particular vaccine or
whether or not that waswarranted is a different
question. But the point is, thatwas kind of what you would call
potentially a signature harm.Another example is, well, that's

(28:00):
not a therapeutic good, but likeasbestos causes mesothelioma,
that's a very kind of specifictype. So you're exposed to a
certain substance, you sufferfrom a certain adverse reaction.
But by and large, what drugs dois they don't have a signature
effect. They don't have aspecific adverse events that

(28:22):
they directly cause what they dois they increase the chances of
other stuff happening. So atypical example was a good
example was the Vioxx. So Vioxxwas this anti-arthritis drug
produced by Merck. And in theearly 2000s, there was this huge
class action in the UnitedStates that showed that Vioxx

(28:42):
basically increasedstatistically, in a significant
in a statistically significantway increased the risk of heart
failure. The problem is, ifyou're an individual, it's very
hard for you to say that it wasVioxx that caused your heart
failure as opposed to any otherstuff like I don't know, maybe
you have hypertension, maybe youhave high cholesterol, you
know...

Maybe you're a smoker.

Maybe a smoker, maybe you drink too much
whatever, like, you know,there's...

It might even just be genetic.

Oh, yeah. So it is very difficult. However, if you
aggregate the number of peoplewho do take the drug, and you
can show a pattern, then thatis, you know, that increases the
chances of a court beingsatisfied that the cause because

(29:29):
at the end of the day, so thequestion of causation, really,
that it is indeed the productthat caused the harm, and then
that can therefore triggerlater. Yeah, I mean, most of
these things then get settledout of court. Right? So Vioxx
settled for billions of dollarsout of court, because when you
see that the huge companies whenthey see that the case might be

(29:51):
going south, they have aninterest that their interest is
in settling because you don'twant to create a precedent. But
it is true that aggregatingclaims, certainly increases the
chances of uncovering potentialrisks that only emerge in the

(30:11):
aggregate than not in individualcases.

And they're also after the effect, you know,
whereas the FDA, the TGA inAustralia, you know, the
processes are in place here totry and avoid this harm
occurring. And then you look,you've reminded me, I mean,
we're going back quite a longway in time. I mean, I think it
was the 1950s, or 60s, but therewas a, there was a medication

(30:37):
for women who was suffering frommorning sickness thalidomide and
that had a secondary, veryadverse effect to their unborn
children, you know, someone willend up not having sort of limbs
or deformed limbs as a result,you know, but presumably, that's
another example of a drug that'sgone through regulatory testing

(31:00):
and all of that process. Yet,unfortunately, it's been
released into the open marketand marketed to consumers who
have used it, and it's resultedin harm. And that's where the
system collapses,.

Actually, it's interesting, you make this
example. So regulation oftherapeutic goods of medicines
in general is not, it's arelatively historically recent
phenomenon. So it started in theUS in the early 20th century on
the back of a, what you wouldcall a drug disaster. So it was

(31:33):
a cough medication that wasimported from Germany. And then
in the US, what the importerstried to do was, they wanted to
turn it into a syrup. And theymixed it with a solvent that was
highly toxic. And as a result ofthis, it was called
sulfanilamide. And as a resultof this, a number of a number of

(31:54):
people died, a number of peoplehad a huge adverse event. And
that is what prompted thecreation of the regulatory
regime, the Food and DrugAdministration and the idea that
you need before you distribute aproduct that has a therapeutic
impact that wants to have atherapeutic impact before you
distribute that into the generalpopulation, you need to test it.

(32:16):
That led the US to in the 50sand 60s, as you say, not approve
thalidomide for distribution inthe United States, which is why
there's been a very just ahandful of cases of people who
got their hands on thalidomidein the United States, whereas in
Europe, it was a disaster,particularly in Germany. And the

(32:37):
thalidomide crisis is whatprompted the European community
at the time to start developingstrong regulatory, free
marketing, authorizationprocedures, which didn't exist
at the time. So at the time, itwas quite loosely regulated. But
on the back of thalidomide, thatis when the whole thing started

(32:58):
properly. And I think that'salso where medical products,
medicines and pharmaceuticals,started to take their own path
in terms of and kind of split upfrom general goods, and become
their own kind of specialcategory that has these special

(33:20):
regimes that require thoroughtesting before they are
distributed. So every drug hasto undergo clinical trials,
right. And a clinical trial is atest in which I don't know if
you know how that works. Butessentially, the principle of
double blind clinical trials isyou have scientists who don't

(33:41):
know you have a group ofscientists, and then you have
two groups of people, two groupsof patients, one group gets the
experimental drug, one groupgets a placebo. Nobody knows
what they're getting. And thescientists themselves don't know
which group is getting what,then there is obviously a
coordinator that knows all thatotherwise it's random. And the

(34:03):
idea is that once you'veundergone the whole, the
treatment course, you look atthe two groups, and you make an
assessment of safety andefficacy. So you look at the
group who receive theexperimental drug, and you see
whether therapeutically, thereis an improvement compared to
the placebo. And then you lookat whether there are side
effects compared to the groupthat got the placebo. And that's

(34:26):
that, in a nutshell, that's howyou make the assessment. And
then their clinical developmentrequires you to do clinical
trials on increasingly big,there's three stages. And the
third stage is on 10s of 1000sof people, right? So but the 60s
and the thalidomide crisis isreally the breaking point in
which governments around theworld are like realize that as

(34:50):
medicines become mass consumedgoods, you do need to have some
special systems in place toensure that once they reach a
broad consumer market, they areas safe and effective as you can
possibly get them to be. Knowingthat there is no such thing as
risk free.

Now I want to stay on the topic of medicines,
we will get into goods. Butlet's just stay on the topic of
medicines for a second. So thereI understand is an Australian
register of therapeutic goods.That registers medicines into
three categories, one being aregistered medicine, second
being a listed medicine. And thethird one being an assessed list

(35:33):
of medicine, are you able tokind of walk us through those
three categories?

Yeah, so essentially, the three
categories that they, I don'twant to get into too many
details, but to make itessentially, what this means is
that you have three differentlevels of a thoroughness of

(36:00):
review. So the registered onesare the ones that have gone
through the whole, the fullreview, and...

Like double blind testing?

Well no, they all have to, they kind of all have
to but like, there may becertain certain medicines that
that are available to physiciansunder certain conditions,

(36:31):
without having been fullyreviewed or approved. So, for
example, the fact is that you dohave, you do have situations
that may warrant patientsreceiving drugs that aren't
fully approved, or drugs thataren't fully reviewed. So that's

(36:53):
what you call the compassionateuse, okay, and the compassionate
use allows physicians todistribute or to prescribe drugs
to patients that have not beenyet fully registered in the
ARTG, so in the AustralianRegister for Therapeutic Goods.
That is, for example, whensomeone is terminally ill, or

(37:15):
someone has like a particularlyaggressive disease for which
there is no other nontherapeutic course of action. So
that's one thing, in terms ofthe various levels of license or
register of registration thatare available in therapeutic
goods, it's a combination ofavailability under certain
circumstances and risk factor.So certain medicines warrant may

(37:39):
require a lesser level of ofreview in order for Australian
authorities to approve them fordistribution. So it's kind of a
technical differentiation, it isnot, I would say, at its core,
any drug that goes into the justto make the broader point, any

(37:59):
drug that gets into theAustralian register of therapy,
the good has to have beenreviewed by the Therapeutic
Goods Administration, and thenthe level of review may vary.

Okay. And Marco, you made an interesting
point to sort of earlier on andI wanted to pick up and that as
before it goes to the itsregistered list, and it's gone
through all the checking and allof that, of course, you know,
when drugs are being, you know,developed, the pharmaceutical
companies themselves or theinventors are going to need to
do their own testing. Is there alicense requirement that they

(38:34):
need to obtain from the TGA? Oranyone else? Or can they
literally just produce a newchemical compound and start
applying it to patients?

No, there are. So every country has different
types of legislation. But by andlarge, this has been
internationally harmonized. Sothere is a regulatory network
called the InternationalConference on Harmonization for

(39:11):
the Regulation of PharmaceuticalProducts for Human Use. It's a
bit of a mouthful, but basicallyit's...

For drug trials, you know, and...

Yeah, it's called ICH, International Conference on
Harmonization. It's abbreviatedas ICH and what they've
developed, among many otherthings is what's called Good
Clinical Practice. Good ClinicalPractice is a set of rules that
you need to as as a, as asponsor, so manufacturer for

(39:39):
example of a new of a new drug.There's a set of rules that you
need to follow for the clinicaltrial to be ethically conducted.
So and ethically conducted meansthat you always have to have the
best interests of the patientsat heart right so you're not the
point what would you want tovoid is situations like, you

(40:03):
know, the Nazi type of testingof using humans as guinea pigs.
So there's a set of rulesunderpinning clinical trials
that are quite stringent. Andthey are internationally
adopted. And they've beendeveloped at this ICH, under
ICH, which is a consortium ofregulators and industry

(40:25):
representatives. Then there'sseparate instruments such as the
Helsinki Declaration that,obviously is an international is
a is a is an internationaldocument that essentially
outlines what the limitationsare for anyone who wishes to
undertake research that involveshuman participants. So there's

(40:47):
ethical limitations that arequite stringent. So it's not
like you can just take amolecule and go and just
distributed and see there's likevery, very heavily regulated
protocols on what kind ofstructures you need to have what
kind of systems need to be inplace. What kind of protections

(41:09):
for the patients that areinvolved need to be in place,
etc. So it's not, no no, it'snot like it's not like the TGA
will accept any kind of datathat comes with no questions
asked, like the data needs tohave needs to be gathered in
observance, observing certainstringent protocols that are

(41:32):
internationally regulated.

Yeah, I've been reading Michael Pollan's book
called How to Change Your Mind,which sort of you familiar with
the book? He's kind of delvedinto the history of the
psychedelic drugs.

Ah yeah.

And then in his book, he, he provides a great
narration of the clinicalresearch into areas like LSD and
MDMA, psilocybin, or in the leadup to the early 70s, with the
war on drugs that then made themprohibited products or product
prohibited compounds to possessand use and they have brought

(42:12):
that whole research area to agrinding halt, at least in the
US and Canada. Although, fromwhat I understand now, having
looked at in a bit more detail,university hospitals like John
Hopkins, etc. are now doingquite large double blind
research into the therapeuticbenefits of some of these, some

(42:34):
of these drugs, and the datathat's coming out of it,
particularly around areas fortreating anxiety and depression,
and seems to be quite promising.But again, I mean, presumably,
at some point in time, if theycan get off the prohibited list
as effectively narcotics, theycould then be used as medicines.

(42:58):
I guess that's the pathway.

Yeah, no, that's, that's, I think the key is you,
as you were saying, the key ishow, how you do these
experiments, right. So one ofthe one of the things that were
a bit horrible about the way inwhich LSD was, was used in the,
you know, 60s 70s. There wasliterally a, I mean, I mentioned

(43:20):
it, the Nazi regime, but ofcourse, the Nazis were not the
only ones who historically haveused humans as guinea pigs to,
you know, test the effects ofcertain of certain compounds on
on, on humans. I think that thatwhole research into LSD and

(43:41):
other psychedelic drugs wastainted by that background of
essentially, unethicalexperimentation that happened
decades ago. And that has reallyset the research back decades

(44:02):
for decades, because actually,now that these types of studies
are being conducted ethically,so observing the ethical
principles of the Declaration ofHelsinki, and following the good
clinical practice guidelines.But then, of course, you start
seeing that, you know, there, asyou say, there may be some

(44:22):
positive therapeutic effectswhen it comes to the treatment
of certain mental diseases.

So, particularly when it's being
done properly, because I mean,from what, yeah, because what I
understand is...

But that's the key, right? The key is that, and it
goes back to your earlierquestion as to you know, how do
you do this? Well, there arevery heavily regulated
protocols, that anyone whoengages in clinical research
needs to follow. And the realityis that if you don't that, you

(44:58):
know, can expose you toliability, civil but criminal as
well. But more, even if wesimply focus on the process that
leads to the approval of thetherapeutic goods, it prevents
the approval from happeningbecause if the data that is
gathered is not gatheredproperly, that data cannot be

(45:18):
used for the purpose of issuingan authorization for
distribution. So it is, it is inthe interest of the companies if
you want as well to follow, tofollow the protocols and to
follow the proper processesbecause otherwise that prevent
that kind of has a negativeimpact on on their investments,

(45:39):
because they're going to be ableto distribute a product that
wasn't appropriately tested.

Well, yeah. And of course, there's a lot of
money at stake because they pumpa lot of money into into
research, the product's notworth anything unless it can get
approval and then be marketedand sold. So that's...

That's not to say that's not to say that there
isn't like there are moralhazards occurring, there are,
How are you feeling? Are youfeeling okay?
you know, there are situationsin which, you know, companies
have cut corners. So, forinstance, I was talking about
the Vioxx case earlier on thatis a case in which America
basically did not disclose astudy that they had there that

(46:18):
they were aware of, for yearsbefore, actually, the class
action for heart failure wasstarted. And one of the points
that was made was that they wereaware of certain side effects,
and they didn't disclose them.So it's not like, you know, I'm
not trying to make the pointthat, you know, everyone behaves

(46:39):
impeccably, but because theydon't, and that's just human
nature, otherwise, we wouldn'tneed laws and regulations. But
but this is to say, but I justwanted to say that they have
quite strong protocols, andparticularly when it comes to
pharmaceutical products andvaccines. They are very
stringent. And they are some ofthese are some of the most

(47:03):
regulated and the most monitoredproducts that we that we use. So
when when when authorities saysomething is safe, I think it's
important to recognize that safedoesn't mean risk free, but it
is overall safe. And it hasundergone through a very
thorough process of testing,including, you know, you were
talking about the fact that youhad three shots of the COVID
Yeah yeah, just a bit of a sorearm for a couple of days, but

(47:25):
vaccine vaccine, I just veryrecently had my fourth one,
COVID vaccine...
nothing, nothing more than that.But it is important to note that
you know, these are safe. Butsafe doesn't mean risk free,
which is why it is you know thatthat needs to be acknowledged, I

(47:46):
think because especially whenyou are trying to roll out
something as widely as avaccine, it is the risk of side
effects obviously increasesbecause it's not like a targeted
medicine that you're only goingto give to a certain segment of
the population, you're giving itto everyone. When you do it,
when you do give something toeveryone, the risk of something

(48:07):
going wrong obviously increases.Which is why you know, it's
important to have systems inplace like you know,
compensation plans and othersuch remedial. So I think you
know, struggling I think in NewZealand, you're using your you
have a general accidentcompensation plan...

In New Zealand, and I believe it to be the case,
we've got a unique system thathasn't been replicated anywhere
else in the world. Now eitherwe're onto something that no one
else has been able to click onto how genius this is, or it's
horribly wrong. Because no oneelse will do it. But yeah, so we

(48:48):
have a no fault accidentcompensation regime, which
applies to medical malpracticeas well. So...

And it would apply to and it would apply to, you
know, COVID vaccine relatedinjuries.

Which makes New Zealand probably the best
jurisdiction in the world totest stuff, knowing that you
can't get sued.

You but no, but actually, it's interesting you
make that point because inAustralia, Australia doesn't did
not have any no faultcompensation plan whatsoever for
any product, making it by theway, an outlier in OECD
countries, because most OECDcountries have some form of no
fault compensation plan,particularly for vaccines. Okay,

(49:32):
so, because the idea is it's youknow, it's the idea of the basic
idea of mutualism. You know, Iask everyone to do something
which protects them but alsoprotects the general community.
So I need to be able to protectthe individual. So the in the
rare rare event of somethinggoing wrong for an individual, I

(49:52):
need to give them some form ofsafety net.

It's almost like a social contract, isn't

Yeah, no, exactly. And Australia was a noticeable
it?
outlier in not having any suchthing. So New Zealand has done
it, you know, it's the it's theother extreme, you have to know
for compensation for anyaccident. So, Australia has
developed as a bespoke specificCOVID-19 Vaccine Claim Scheme,

(50:22):
it's called. And it is thereprecisely because, you know,
it's been rolled out massively,it's been mandated by a number
of states in a number of for anumber of professions. WA, where
I am Western Australia hadpassed one of the smallest one

(50:42):
of the strangest mandatoryvaccination policies in the
world like 75, it was mandatedfor 75% of the workforce, which
is quite extraordinary. And soof course, you need to have some
kind of safety net, because youneed to be able to give back if
someone has an injury. But backto the point you made, which is,

(51:07):
you can't get sued. Well,actually, even before Australia
implemented a no faultcompensation schemes company
could not be sued, because thatwas in the procurement
contracts. So, you know,Australia being one of the vast
majority of countries in theworld that did not produce these
vaccines. So we had a productionsite for the AstraZeneca one,

(51:28):
but that quickly went out thewindow because the vaccine, the
rollout of the AstraZenecavaccine was stopped due to the
concerns around the thrombosisside effect. But we don't
produce mRNA vaccines like thePfizer one, the modern one. And
so we have to import them.

I think they produced in India, that's what I
understood. A lot of them are.

They were mostly produced in the United States,
and some in Europe. And I thinknow the production, the
production is scaling up. Andwhen you need to scale up
production, you have to go tocountries like India, for
example. Because, well, first ofall, they have a very highly
developed pharmaceuticalindustry. So they do have kind

(52:13):
of the facilities. But also, youjust can't do it in one country.
Like even if it's the UnitedStates, if you need billions of
people to be vaccinated, youcan't do it there. It's too
expensive. It's too and there'salso the capacity is limited.
But the interesting thing isAustralia, like pretty much
every other country thatimported mRNA vaccines,

(52:36):
introduced liability exemptionsfrom liability clauses in their
contracts and the procurementcontracts, all had clauses
whereby if something went wrong,and individuals started suing
for injury, the government wouldpay the bill, not the manufacturer.

So now...since the government was indemnifying,
the pharmaceutical companiesagainst liability.

Yeah, and so I think the no fault compensation
plan is like a step forward,like okay, well, if the
government is going to foot thebill, you might as well remove
the element of litigation andhaving to prove the fact and
fault or whatever you need toprove under in. So negligence
claims for therapeutic goods arealmost impossible, because
proving that a manufacturer wasat fault, is really diabolical,

(53:19):
there's too much of an asymmetryof information between consumers
and patients and manufacturers.So which is why we have consumer
laws that include normallythings like product liability,
product liability is is a strictliability regime where what you
have to show is that the productis defective. So it's below the
safety that the public andgenerally is generally entitled

(53:39):
to expect. And there is a causallink between the harm and the
defect. Now, the problem thereis that proving that a vaccine
is defective, is almost asdiabolical, diabolically hard as
proving that a manufacturer isat fault. And so what no fault

(54:01):
compensations plan do is thatthey remove the requirement to
prove that a vaccine wasdefective. And all you have to
show is that you took thevaccine and that you had an
adverse event that was linked tothe vaccine. And then some
plans, like the New Zealand one,I think, and certainly others
around the world are open ended.Okay. So you have to make

(54:25):
essentially, you have to make acase that on a balance of
probabilities, but it's not asstringent as the civil
requirements, you know. So in anegligence claim, you have to
make the case that on thebalance of probabilities, the
breach of the defendant causedthe harm. In these situations,
it's more of a you have to makea prima facie case that the

(54:46):
vaccine caused you harm. Butother countries like Australia,
on the other hand, adopt adifferent type of approach,
which is a closed list. Ofcourse it's a list that is that
gets updated as new data comesin. But essentially, if you can
show that you took the vaccineand you have an adverse event

(55:07):
that is on the list, youautomatically become eligible
for the compensation. So there'stwo different types of
approaches for the same thing.

Would that span out, because I mean, we have had
a New Zealand, and I'm not sureabout Australia, but there have
been some limited examples wherethe reaction has been fatal
people have have actually died,not large numbers that I'm aware
of. But would that lead to anAustralia that the family
bringing some form ofcompensation claim for the

(55:37):
estate?

Interesting, that's an interesting one. So the
injury claims is for thepatient, not for the not for the
family. I think so the the casesin which there has been a fatal
adverse reaction. In Australia,I believe, all involved, or

(56:00):
almost all involved theAstraZeneca vaccine, so it was
from the thrombosis. Now, thereare other social security
mechanisms that can assistfamilies in those situations,
the compensation scheme itselfis actually targeted at
individuals, not their families.So it is, and that is a

(56:21):
limitation in a way, of course,but I think the point is,
particularly, because the vastmajority of adverse events tend
to be temporary, or, you know,they can have, they can be more
or less prolonged in time, butwhat they all tend to resolve.

(56:44):
So like the, you know, the heartissues that can be linked to the
Pfizer vaccine, for example,when they're in a one, they all
tend to resolve within a certainperiod of time. However, during
that period of time, you maylose income, you may lose a
manager, you may lose a wholebunch of things. So that's what
the compensation scheme tends tofocus on. So the fact that is

(57:08):
literally providing a safetynet, when you're essentially
disabled for a certain period oftime, if you're disabled
permanently, there are alsoother schemes that kick in, in
Australia. So like, there's theNDIS, the National Disability
Insurance Scheme. And so that'sa different kind of, depending
on the gravity, I think thepoint of the no fault
compensation scheme was reallyproviding a safety net for those

(57:30):
who were experiencing seriousadverse event that had a serious
impact for a discrete period oftime.

So Marco, before we move off the COVID
vaccine, because I want to getinto the area of medical
devices. And I want to pick yourbrain on that one. But before we
do just just couple of points.One is we're able to now stand
back, you know, where are we,we're in October 2022, you know,
20 months, from, I guess, the,you know, 22 months and from the

(58:05):
pandemic being announcedetcetera. What's your assessment
on a scorecard, if we do a scaleof 1 to 10, in terms of the
Australian regulatory responseto approving the various
vaccines? I mean, did theregular, and I know it was an
emergency. And I know, it'sunprecedented. But did you know,

(58:29):
did they perform?

I think the regulatory regime in Australia,
but I would say, around theworld, mostly performed
remarkably well under the levelof pressure that it was
operating. So it is easy todayto you know, cast, you know, an

(58:51):
eye your eye back and be like,ah, they were rushed here, or
they didn't do well enoughthere. But I think it's
important to remember where wewere at in early 2020. And in
mid 2020, and when the firstwave was really, really, really
hitting Europe and the UnitedStates incredibly hard. And the

(59:13):
fact that, you know, we wereable to have a number of
different vaccines within such ashort period of time is
remarkable. And the fact thatnone of them really carried
risks of serious adverse eventsabove what was still, I think, a

(59:36):
marginally small number ofcircumstances that I'm talking
about. And I have to say it'simportant here to distinguish
between people who are healthyand versus people who have like
pre existing such as like immuneconditions. Yeah. Because people
with that sort of, for a lot ofpeople with underlying
conditions. The pandemic isactually a lot worse now almost

(59:58):
than it was then, because theycan't have the vaccine. And so
they are, I know, I'm, as youknow, I'm an academic, I have
certain students who have beenessentially locked in their
houses for well to two years nowover and they have no realistic
prospect of ever coming outbecause they know that if they

(01:00:20):
get COVID, that can be fatal tothem, given their underlying
condition. And their underlyingcondition is also what prevents
them from being vaccinatedbecause they have certain risks
of adverse events, they're soegregious that they actually
can't do it. So I think it'simportant not to, you know, fall

(01:00:41):
into the trap of like, what youwould call an ableist narrative
of the pandemic. But let's saythat by and large, I think the
vaccines have been developed atbreakneck speed, and they are
remarkably safe and effective.And the fact that the
AstraZeneca potential fatal sideeffect was picked up so quickly

(01:01:01):
was, you know, I think, atestament to how well these the
systems work. And I think, youknow, if you want to segue into
medical devices, I think, ifthere was ever like a, you know,
if there was ever proof that wedo have systems that are not
perfect, but by and large work,the COVID vaccine was probably

(01:01:25):
the biggest stress test that anyregulatory regime has ever, ever
endured.

Chris Patterson (01:01:30):
Yeah, and look, I guess the the point that I'm
quite keen to get your view on,is that it's all very well, the
pharmaceuticals producing aproduct like in this case a
vaccine. But the regulations theand the regulatory approval
process, ordinarily, as you, asyou've told us, and rightly so
can take years, but in thiscase, it was done at an

(01:01:53):
accelerated pace. And is it yourview, do you feel that looking
back on it, because, you know,hindsight is always 20/20, you
know, we've got the benefit ofit, is that the Australian
regulatory regime responded tothe the emergency that it was in

(01:02:14):
an efficient way and certifiedit and approved it, got it, and
it was then available fordistribution.

Marco Rizzi (01:02:22):
Yeah. So just to just to clarify a point that
you've made. So my answer toyour question is yes, I think it
did. In terms of like, why, howon earth did these vaccines come
to exist in such a short amountof time when they normally takes
so a new vaccine can take up to15 years to be developed from

(01:02:45):
development to rollout? So howon earth did we do that in a
year? I think there's a littlebit of myth, mythology around
this that needs to be addressed.The reality is that often it
takes this long, because it canbe really hard to run clinical
trials, it can be hard to findvolunteers, it can be hard to

(01:03:07):
find funding. Okay. So in thisparticular situation, we had an
endless supply of volunteers,and unlimited funding, everyone
was pouring money into thisparticular into this particular
research. So when you haveunlimited funding and unlimited
volunteers for clinical trials,that dramatically decreases the

(01:03:31):
amount of time that isnecessary. So and that has
nothing to do with how thoroughthe tests are, it's just that
you're able to do them muchquicker, because the 15 years
that it normally takes, it's notlike you use your productively
using time for 15 years, thereare gaps of like two or three
years in which nothing happens,because you're just waiting.

(01:03:51):
Whereas in this case, again,this was not this didn't happen.
The second thing is that thereare circumstances in which
regulators can the what they sayis fast track, they can fast
track the approval of a drug.And that's, you know, a pandemic
is the obvious case. So whenthere is a disease that is
threatening a large portion ofthe population, fast tracking

(01:04:16):
doesn't mean you just take agamble. fast tracking means that
you look at you still need tohave like at the front end data
that satisfies the regulator on10s of 1000s of participants. So
for example, I think theAstraZeneca one before it was
approved had was it had beentested on 30 to 40,000 people

(01:04:40):
and similar numbers, I thinkwork for the Pfizer and Moderna
vaccine. Fast track simply meansthat you actually make a
preliminary assessment on thebasis of this initial data. You
roll out the vaccine and thereare stringent conditions you
know, you have to monitor andthen you have to keep doing
clinical files as the vaccine isrolled out and the TGA or so the

(01:05:03):
regulator performs what you calla rolling review. And that's
what, for instance, allowed thethrombosis side effects linked
to the AstraZeneca vaccine to bepicked off so quickly and acted
upon so quickly. So, yes, Ithink I think the regulatory
regimes in Australia but acrossaround the world, were, were

(01:05:24):
remarkably well under the levelof pressure that they were
operating during the pandemic.

And I guess, in a way that the lessons or the
examples from that may serve aswell into the future, because of
course, I mean, I don't knowwhat your view, I'm keen to hear
what it is, but I don't thinkthis pandemics actually over. I
mean, we're still seeing in NewZealand daily cases into the
1000s. And, of course, the virusCOVID-19 is, the variants are

(01:05:55):
changing. So there are newvariants that are developing.
And some of the signals comingout of particularly Europe is
that some of these variants areparticularly able to evade
immune responses, and quitepossibly the vaccines that we've
all had. So we may be looking atheavy to go for completely new
rounds of vaccination.

Yeah, I mean, well, the vaccine I had two days ago
was Bivalent, so it was theoriginal strand. And then
there's some specific Omicronprotection but how effective
that will be, I guess we'll see.But number one, the pandemic is
definitely not over. There's thethe waves keep going up and

(01:06:39):
down, I think we're goingtowards the normalization of
these waves. And I think that itis not entirely, it is actually
quite possible that what we'regoing to be looking at is a
seasonal vaccine for COVID, muchlike we have for the flu. And

(01:07:01):
whether it's going to be yearlyor or, you know, biannual, I
don't know, we'll that willdepend. But I obviously the
virus we haven't we haven'tdefeated the virus, the virus is
now in the community globally.And we're going to have to deal
with that, which is quiteconcerning, particularly for

(01:07:22):
individuals who areimmunocompromised because it
that means there is a long termissue of how are we going to
protect these people. But from aregulatory perspective, I
suspect what pretty much everycountry has is a special regime
for the flu vaccine. So the fluvaccine, you don't need to
undergo the same level oftesting that you would need for

(01:07:44):
a new brand new vaccines, allyou do is essentially, you add
new strains to existing ones.And that is a very speedy
process. And essentially, everycountry in the world has a
special has a special regulatorypathway for those vaccines,
because you need them on ayearly basis. And I think it is

(01:08:04):
quite conceivable that COVIDvaccines will end up having the
same type of parallel kind ofregulatory regime whereby like
if all you're doing is addingnew strands, adding new sorry,
adding new new streams andadding new variants to an
existing vaccine, the regulatoryreview will be essentially
minimal. Because we already knowit's an exam. The point is, it's

(01:08:27):
a technology that exists and itis well established. We know it
is safe and effective. All we dois we just make it effective
against the new a new version ofthe same, the same disease.

Fascinating. And look just lastly, before we
move off medicines, it did occurto me before I was just thinking
about and I've mentioned the FDAand the FDA being sort of
somewhat more risk averse. Youcan buy over the counter and use
in the United States, melatoninbut in New Zealand, it's a

(01:09:01):
prescription drug. Now I don'tknow what the position is with
melatonin in Australia can youcan just buy that at the
Chemists Warehouse without aprescription? Or is that is that
just still regarded as being abit too risky?

So melatonin is I think in Australia now Australia
is like New Zealand it is. SoAustralia generally is quite
strict when it comes tomedicines. So even things like
topical steroid creams are verytend to be prescription only.

(01:09:40):
And so melatonin I'm fairly surethat the regime is the same as
in New Zealand so it'sprescription only.

I guess sort of maybe the you know, America, my
perception is as they arebecoming more liberal around
therapeutics, I mean a goodexample probably is their
cannabis industry, both inAmerica and in Canada are a
multi billion dollar industryproducing products, some of

(01:10:08):
which I guess you would call asbeing therapeutic. Whereas, both
in New Zealand and Australia,it's only been in recent times
that doctors could prescribemunicipal cannabis products. All
of those struggling with opioidyou know that you can't take
opioids.

Well cannot cannabis is the therapeutic use
of cannabis is, you know, as thevery kind of specific field and
there is actually abundantevidence, like overwhelming
evidence that in certainclinical circumstances, cannabis
has a significant, significantlypositive therapeutic impact on

(01:10:46):
patients. But I think generally,you're correct in saying that,
the FDA tends to have a moreliberal approach a more, it's
almost like, because it is, Imean, my take on this, having
looked at this, these theseissues for a number of years
now, is that once again, if youlook at the regulatory regime,

(01:11:13):
in separate segments, the FDAand the American regime tends to
be more permissive. So there isindeed a greater propensity to
risk, okay, so you know, we'rekeen that people should have
products available, thethreshold is lower that you need
to meet in order. On the otherhand, if you look at it

(01:11:35):
holistically, there's the factthat there's so much more
litigation occurring in Americanlitigation is so much more
accessible. Particularly not notgenerally speaking, but
particularly when it comes tothese particular goods, given
the kind of the way in which itis structured, that you have to
factor that in. So overall, thethe American approach is one

(01:11:56):
that looks at, you know, givemore opportunities at the front
end, and also providepotentially more remedies or
more opportunities for causes ofaction at the back end. Whereas
the European one traditionallyis a lot more like less prevent
the spirit to prevent accidentsfrom happening in the first
place. And then, you know, theopportunities to litigate are

(01:12:19):
not as diffuse and not asavailable as in America.

Okay, Marco. Well, that's probably a good
segue into because I did want totalk about medical devices
before we wrap up, and the onewas the pelvic mesh litigation.
That seems to be picking up onyour point, that exact point,
you know, when something goeshorribly wrong, I mean, what can
you tell us about the pelvicmesh litigation?

Yeah, so I think I think the importance so there's
a premise to make here. So inAustralia, pelvic mesh is a is
a, so a pelvic mesh is animplantable device. So it is an
implantable device, typicallyimplanted on women, or
conditions... So the ones thatwere that formed the object of
litigation in Australia weremeasures that were used for

(01:13:09):
pelvic organ prolapse, or stressurinary incontinence. So these
are mildly, essentially minorconditions, they're more, they
tend to be more of a, they canbe, they can be serious, but by
and large, they tend to be morelike a discomfort or like they
affect quality of life more thananything else. And the pelvic

(01:13:30):
mesh is essentially it's, it's amesh that you implant, and that
keeps everything together,essentially, and therefore
prevents the prolapse orprevents the incontinence. Now
that what happened in Australia,and actually across the globe,
really, is that it turned outthat these a lot of these

(01:13:51):
meshes, particularly the onesthat were imported by Johnson
and Johnson into Australia or byand produced by imported and
produced in Australia by a firmcalled Ethicon. The problem was
that they carry the significantincreased risk of chronic pain.
And, and, and what happened isthat 1000s, literally 1000s of

(01:14:14):
women who had these, who hadthese meshes implanted for minor
conditions ended up having theirlives ruined, essentially,
because, number one, they werenot aware of the risks, the
risks were not acceptable, therewould not have, they were not
risks that for a product of thatkind, the general public would

(01:14:37):
have accepted as you know,reasonable. And third, the issue
is there is no real remedy in intherapeutically speaking because
in the vast majority of casesyou can't remove it so it's just
going to be there forever. Whathappened there? What happened is
that we in for medicines, we'vetalked about the fact that

(01:15:00):
there's this really, really welldeveloped regulatory regime that
with very thorough pre marketingtesting, that really comes from
the early 20th century in theUnited States and the mid 20th
century in Europe on the back ofdrug disasters. The problem with
medical devices is that for anumber of reasons that
historically they have the theyhaven't developed this

(01:15:21):
therapeutic goods worthy of aseparate category of regulatory
attention. But they have by andlarge, been packaged into just
consumer goods. And the fact isthat medical devices, when we
think of medical devices, wenormally you know, you can think
of stuff that is really fancy,like I don't know, pacemakers,
or other such things. Butmedical devices are a huge

(01:15:46):
category that includes anythingfrom band aids, condoms,
prosthetics, implants, soeverything is a medical,
anything that you use fortherapeutic diagnostics,
treatment monitoring, is can bequalified as a medical device,

(01:16:07):
and they're regulated indifferent classes. So every
class has a different type ofpotential. Now, the problem is
that, as I said, aboutmedicines, what's that when I
said, I'm on medicines is trueabout devices, Australia, mostly
imported devices. And a lot ofthe devices imported came come
from the European Union, and theEuropean Union has had a huge

(01:16:29):
fail failure or regulatoryfailure when it comes to medical
devices, because essentially,what it did is that it did not
create a regulatory regime likefor medicines, but it put the
regulation of goods of medicaldevices into the bigger bag of
regulation of goods, consumergoods. So the way it happens is,

(01:16:53):
you have a broad legislationthat gives goals, general goals.
And then you have what arecalled notified bodies, these
are typically private companiesthat issue quality assurance
certificates. So a manufacturerwill go to a notified body and
say, like, Hey, I have this newproduct, and you just, you know,

(01:17:17):
test it against certainstandards. And then if you're
satisfied that you know it, itmeets the standards give us the
quality assurance certificate.And the problem is, if you if
you kind of outsource that to anindustry and their core business
is performing quality assurance,the risk of moral hazard is
huge. And just to give anexample, that is relevant to

(01:17:40):
mesh, in 2018, there was thishuge scandal called the Implant
Files. So there's a group ofjournalists called the
International Consortium ofInvestigative Journalists, the
ones who uncovered the PanamaPapers. So they call it they had
this huge investigation calledthe Implant Files. And there was
this one Dutch journalist thatdid this incredible thing. So

(01:18:04):
she she bought a mandarin netfrom the supermarket. She cut it
out in a way that was fancylooking. And it was literally
like the, you know, the redmandarin nets that...

Yeah, you go to the grocery store, you go into
the fruit section and there'sthe mandarins, they're in a net.

Yeah, exactly. So she took the mandarins out, she
cut the mesh the net in a waythat looked fancy. And then she
produced the bogus technicalfile. And she introduced herself
with a few colleagues who arenot one of these notified bodies
to ask what you know, we havedeveloped this cool new mesh,
would we get approved? Andthere's and the reality is that

(01:18:44):
they had they received thepreliminary approval from a
notified body on the basis ofthe fact that oh, yeah, many
similar products already existon the market, and therefore I
don't see this as an issue. Now,that was obviously they didn't
market the net, but they didthat to show how lax the
regulatory system was, and thesemeshes that were distributed in

(01:19:07):
Australia, all came from thisEuropean, very weak system,
regulatory system. So I thinkwhat I'm trying to say is that
the problem with medical devicesis that they do they are they
can be as invasive and they canhave as dramatic an impact on
the life of patients asmedicines do. But for historical

(01:19:32):
reasons, they have escaped thelevel of scrutiny that medicines
have on the other hand, gainedvery early on in the piece and
it is only now I think that weare moving towards a much more
thorough and a much more closeattention to pre marketing pre
distribution requirements fordevices.

Yeah. Hey Marco. I wanted to thank you,
grazie, for joining me on theLaw Down Under Podcast and look,
this has been a fascinating,deep dive into health law but
also, you know, therapeuticgoods. You've given us a lot of
insights, there's a lot there totake in. I really appreciate it.
And look, I hope that we can, wecan keep in contact, because

(01:20:14):
that's that there's some topicshere that I'd actually really
like to get into in more detailwith you're at a later time. So
thank you for joining me.

Oh, absolutely. If you want to chat about devices
more in more detail ever, anytime. Thank you.

Absolutely. And it's been really good. So look,
enjoy the rest of your day. Andthanks for joining me on the podcast.

Thank you again for having me.

Thank you for tuning in and listening to this
episode of the Law Down UnderPodcast. You're welcome to join
in on the discussion via mypodcast page, which you can
access at patterson.co.nz That'spatterson.co.nz. Thanks for
supporting the podcast and tunein again for more on the law,
its application and the futureof the law here down under.

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E20 Regulation of Therapeutic Goods and Medical Devices - With Dr Marco Rizzi

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.css-14f5ked{margin:0;word-break:break-word;display:-webkit-box;-webkit-box-orient:vertical;box-orient:vertical;-webkit-line-clamp:2;overflow:hidden;}E20 Regulation of Therapeutic Goods and Medical Devices - With Dr Marco Rizzi