Regulation of Therapeutic Goods and Medical Devices - With Dr Marco Rizzi
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Transcript Commences
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Chris Patterson: In this episode
of the podcast, we discuss the
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regulation of therapeutic goods
and medical devices. It's quite
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a timely episode because we're
still in the middle of a health
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pandemic. How our laws react to
and support advances in medical
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technology and science is
critically important for the
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well being of everyone. I'm
really privileged that I was
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joined by an expert in this
area, and I hope that you'll
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enjoy the podcast as well.
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Joining me today on the podcast
is Dr. Marco Rizzi, who is an
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Associate Professor and Deputy
Head of the University of
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Western Australia's Law School.
His research focuses on the
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protection of health and safety,
and the relationship between
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law, politics and the market.
Marco has a PhD in Law and a
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Master's degree in Comparative
Law from the European University
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Institute in Italy. He has a
Master's degree in Civil Law
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from the University of Pisa.
Marco has filled many positions
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at the University of Western
Australia, including as a member
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of its Human Research Ethics
Committee, an Academic Conduct
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Adviser, and a Senior Lecturer.
Before that, he worked at the
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University of Seychelles. In
September 2022, earlier this
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year, Marco was awarded a
Research Award for Early Career
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Researcher by the University of
Western Australia's Law School,
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and a Commendation Award in
Research Impact Innovation by
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the University of Western
Australia's School for Social
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Sciences. Hello, buongiorno, and
welcome Marco.
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Marco Rizzi: Buongiorno. Thanks
for having me.
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Chris Patterson: That's the
limit of my Italian. I'm not
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going to try and speak any after
that. I'd just embarrassed
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myself terribly. Yeah. How many
languages can you speak just out
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of interest?
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Marco Rizzi: So Italian, French,
as mother tongues, English, bit
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of Spanish, bit of German.
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Chris Patterson: You know, this
is the thing. Kiwis and Aussies
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are just kind of so limited. I
mean, if we're lucky, we've kind
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of almost got a conversational
grasp of English. But beyond
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that, there's not much happening
there. I mean, I've tried very
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hard to learn Spanish. And I
mean, I can certainly hold a
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conversation in espagnol to a
limited degree. But that's,
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that's the limit. It always
impresses and admires me when
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I'm in Europe, and I meet
Europeans, and they can speak,
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you know, 5 6 7 languages. It's
very impressive.
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Marco Rizzi: Yeah. Well, I mean,
it's luck of the draw, where you
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were born kind of determines
that a little bit.
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Chris Patterson: Well, it does.
Yeah, it does. But also having,
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you know, the interest and the
desire to learn other languages.
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I mean, I think it's a great,
great thing to do. Anyway, we
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get to talk about health law,
but in particular, we're going
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to talk about law relating to
therapeutic products, etcetera.
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And one of the first things I
wanted to ask you about with
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this, because I'm super
interested in this is, you know,
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what is actually a therapeutic
good?
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Marco Rizzi: Yeah. Thanks,
Chris. Thanks for having me.
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Also, thank you for the
promotion. I'm Associate
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Professor for the moment, but I
certainly aspire to
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professorship one day. In terms
of your question, so therapeutic
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goods. In Australia, we have
this legislation called the
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Therapeutic Goods Act. And then
we have a Therapeutic Goods
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Administration, which is an
independent agency that oversees
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the regulation of these goods.
So what are they? Essentially,
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any product that has an intended
therapeutic effect, or that is
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used for the treatment or
diagnosis, the prevention, the
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monitoring of health conditions.
And I think what is interesting
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about the Australian context is
that it is quite unique in using
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a generic like overarching
definition. Normally, what you
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have is like, for instance, in
Europe, you have the European
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Medicines Agency. I believe in
New Zealand, you have PHARMAC,
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which is also focused on
pharmaceuticals prevalently. In
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the United States there's the
Food and Drug Administration, so
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again, like the emphasis on
drugs, although the Food and
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Drug Administration also looks
at medical devices. What we have
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in Australia is an attempt to
basically bring every good that
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has this intended therapeutic
use under one big umbrella. And
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that is where this term
'therapeutic goods' comes from.
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What it means, in fact, is
therapeutic goods tend to be
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medical devices,
pharmaceuticals, including
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vaccines. So these are the two,
the two big families of
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therapeutic goods.
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Chris Patterson: Okay. So, like
if I go to the Chemist
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Warehouse, for example, you
know, obviously anything that
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requires a prescription is going
to fit into that sort of
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classic, it's a drug, it's for
therapeutic use. But sometimes
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the line isn't particularly
clear as to whether something is
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being, you know, produced or
promoted for therapeutic use.
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Maybe an example is just sprung
to mind as you know, late at
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night, I'm working to get some
submissions out that are due the
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next day and I'm feeling a
little bit tired. So, you know,
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I might I might crack open a can
of Red Bull, full of caffeine
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and other chemicals. Would that
be would that fit into the
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category of being a therapeutic
good?
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Marco Rizzi: Well, I mean, it
probably should, but no Red Bull
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is not regulated as a
therapeutic good. It is, it
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probably falls under the more
the lesser category of like
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supplements. So, but it is true
that when you walk into Chemist
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Warehouse, you are obviously you
have a wide range of choice of
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therapeutic goods. So, the most
heavily regulated ones are the
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ones you would call prescription
drugs, typically. Prescription
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drugs are the ones that can only
be dispensed with a physician's
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prescription, whereas you also
have lots of over the counter
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drugs. So for instance,
ibuprofen or Panadol, like the
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stuff that we you know, use
quite frequently aspirin,
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etcetera. All of these are
therapeutic goods. They are
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regulated. However, they are
considered to be safe for
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consumption without a
physician's direction, okay. So,
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basically, what determines
essentially whether a medicine
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will be a prescription medicine
or over the counter is the
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degree of risk that is
associated with consumption. So,
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certain drugs, know every
pharmaceutical that is there has
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ever been produced, carries a
certain degree of risk. So, it
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is impossible to have drugs or
medicines that are completely
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risk free. Now, depending on the
risk profile, so, what the
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adverse the potential adverse
event is, how frequent the
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adverse event may be, then
regulators can make the decision
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to make the drug or the medicine
prescription only, or over the
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counter. Okay, so that's, that's
a little bit how the system
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works in a nutshell.
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Chris Patterson: Okay. So do I
understand that, you know, as
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part of the Therapeutic Goods
Administration, and the body
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that the TGA that's
administrating it, that they are
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undertaking every time there is
a therapeutic good, that is, you
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know, being produced in
Australia, or being brought into
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the country, they're looking at
it to say, you know, what's the
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risk profile with this product?
And then where does that fit in
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the categories of, or
categorizing that particular
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product? Is that the approach
that's taken?
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Marco Rizzi: Yes. So the
Therapeutic Goods
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Administration, if you look
there, the legislative framework
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that they operate under, they
basically take what's called a
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risk based approach to
regulation. A risk based
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approach to regulation means, so
you can have different types of
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approach. There's more
conservative ones like
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precautionary. Precautionary
approach means that essentially,
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if there is the potential for,
you know, harm, you just take
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action, you take preventative
action, of course, the
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precautionary approach to risk
in the realm of therapeutic
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goods doesn't work. Because if
you're going to be
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precautionary, as a general kind
of guiding principle, well,
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you're never going to have
innovation. So, a risk based
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approach emphasizes that behind
every decision to authorize
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certain products for you know,
rollout or consumption in the
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market or to allow physicians to
prescribe it, there is a an
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underpinning cost benefit
analysis essentially. Or risk
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utility analysis. And where the
Therapeutic Goods, the
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regulators are satisfied that
the benefits outweigh the risk,
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they will approve the product
for marketing and for
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distribution. Now the mechanism
that is followed, the more
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granular mechanism that is
followed is quite different
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depending on the type of
therapeutic goods. So,
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pharmaceuticals, including
vaccines follow a certain type
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of review. Medical devices
follow a different type of
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review. And then there's the
additional layer of complication
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that is whether the product is
produced domestically or
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imported. Now, the reality is
that a country like Australia,
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and I believe New Zealand is
similar in this sense, does not
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have a huge domestic industry.
So there's not a whole lot of
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production and in development,
that product development that
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happens domestically, the vast
majority of therapeutic goods
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that are distributed in
Australia are imported. So you
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need to have parallel kind of
regulatory mechanisms. One is
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for what happens when you know,
something is produced in house
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and a different type of review
for a product that has been
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produced elsewhere and that is
being imported.
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Chris Patterson: Okay, so where
would like licensed
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manufacturing, sit into that
equation? You've got a
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pharmaceutical company sitting
in, let's just say, in Perth in
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Western Australia, and it's
producing medicines, but under
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license from an overseas
company. Where would that sit?
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Marco Rizzi: Well, I think, so
by licensed, do you mean the
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intellectual property regime or?
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Chris Patterson: For example,
the patents, so there may be a
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therapeutic medicine, that an
Australian company hasn't
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developed themselves, so they
haven't gone through that
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developmental pathway in
Australia, but rather, what
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they're just simply doing is
they're manufacturing it under
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license of which is held by an
overseas pharmaceutical company.
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Marco Rizzi: Yeah. So it's
important to to keep the two
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regimes separate. So
intellectual property, licensing
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and all that operates at one
level and that has, that
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basically operates at the level
of guaranteeing intellectual
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property rights of developers
and manufacturers. So you don't,
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and this was particularly this
was a big thing with the COVID
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vaccines, obviously. So the idea
is, if you hold the patents, if
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you hold intellectual property
rights over the design of a
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certain drug, what you don't
want is others to replicate that
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particular therapeutic good,
without essentially either
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paying you or without, you know,
some kind of agreement that
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guarantees your intellectual
property rights. Now, whether
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that is whether that is
desirable or not, is one
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question. But setting that aside
for a second, what the TGA does
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is very different. So regardless
of the intellectual property
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regime, if you want to market a
product, whether or not you hold
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the patent, or whether you're
producing it, you know, your
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license to produce something
that has been invented by
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someone else, you still have to
undergo the testing, and you
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still have to undergo the review
by the TGA. So what the TGA
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looks at, it's not it has
nothing to do with intellectual
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property. It has to do with
safety and efficacy.
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Chris Patterson: So can I just
jump in here? Because I want to
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be clear on this. Whether our
local pharmaceutical company has
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developed a product themselves,
or they're simply manufacturing
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it, a drug that's actually been
developed by an overseas
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company, it makes no difference.
The testing still needs to be
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undertaken. Is that is that
compared to for example, if the
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pharmaceutical company was just
an importer, like they were just
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literally importing the
therapeutic product into
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Australia, it makes no
difference.
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Marco Rizzi: So okay. That's a
good question. So let me break
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it down in into digestible
pieces. So what the TGA does is
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it authorizes a certain product
for distribution. That has to
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happen anyway. Okay, so whether
the product is imported,
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developed domestically, invented
domestically or produced under
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license domestically, that
doesn't matter. If you want to
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distribute like a therapeutic
good, a medicine, it has to be
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authorized by the Therapeutic
Goods Administration, which
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means that the Therapeutic Goods
Administration needs to be
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satisfied that it is both safe
and effective. We can talk about
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how... But first, let me just
explain it. So there's the
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issue, the risk, of course, is
that if you say an American
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manufacturer or a European
manufacturer wants to sell their
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drugs in Australia, which
happens all the time, like
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actually, the vast majority of
the drugs that we consume in
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Australasia are not designed and
developed in Australasia. What
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happens is that typically, the
therapeutics administration will
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end the sponsor, so the company
that wants to have that product
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registered will normally provide
the TGA with approvals from
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overseas companies. So the TGA
will be aware of the fact that a
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certain product has been
approved, say by the American
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Food and Drug Administration, or
by the European Medicines
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Agency, or the Japanese
regulator, etc. And that can can
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speed up the review in a way or
it gives at least a starting
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point where you can but
nevertheless, for medicines in
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particular, and this is where
there is a bit of a divide
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between medicines and medical
devices, medicines, the
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therapeutic good, still has to
undergo an independent still has
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to perform an independent
review. So again, the COVID
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vaccines is a good example. So
Australia approved the COVID
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vaccines later than the United
States FDA, the UK MHRA or the
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European Medicines Agency, it
was it happened afterwards.
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Chris Patterson: Okay, can I
just stop you there Marco? Just
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because one thing that you've
raised, which jumps a question
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out to me is, to what extent is
the TGA influencedby an
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organization like the American
FDA, where the American FDA have
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certified, you know, a
therapeutic, good, or a medicine
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as being fit for use? does? Does
that play a role in any way?
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Because it seems to me that,
shouldn't we have some
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confidence that if the FDA are
approving something, then it
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must be safe?
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Marco Rizzi: Certainly,
regulatory authorities across
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the world do not operate in a
vacuum. So there are networks
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and bilateral agreements between
between regulators particularly
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so for example, the TGA, the FDA
or the European Medicines
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Agency, they are there is a
constant, there is a constant
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interaction, because the idea is
you what you don't want to do is
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you don't want to you don't want
to duplicate efforts, you don't
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want to kind of reinvent the
wheel at every point in time. So
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is there some some level of
influence? I would say, more
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than the FDA influencing the
decisions of the TGA. It's it is
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more the case that the these
regulators all operate in a sort
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of coordinated way to an extent,
particularly when it comes to
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drugs that are globally
distributed. So it does does it
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have does it have an influence?
Certainly does. Because it does
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mean that one regulator has kind
of gone through the steps that
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are required to be satisfied
that a certain product is safe
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and effective. That does not
mean however, that it
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automatically translates.
Because the regulatory
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frameworks aren't exactly the
same. There are levels of risk.
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So the United States
traditionally is a little bit
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more risk, has a bit more of a
propensity to risk compared to
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for example, the European one.
So, which is why certainly it
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does have it doesn't mean that
you're not starting from scratch
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when another regulator has
already performed a review, but
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you still conduct an independent
review of medical data.
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Chris Patterson: Yeah, I mean,
from my perspective, and I know
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this is very much a naive one,
because it's this isn't my area
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of expertise, but more as a
consumer of medicines, and I
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mean, I've had three shots of
the vaccine and getting ready
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for my fourth one coming up
soon, is that I did sort of
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stand back and think to myself
have, you know, this pandemic
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has created a very unique moment
in time where there was an
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absolute risk to the health and
well being of the entire planet,
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okay, without being overly
dramatic, okay. And the miracle
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of science was that within a
short period of time, a handful
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of the pharmaceutical companies
produced the vaccine, like,
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quite quickly, you know, this
rDNA vaccine, but then it had to
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go through regulatory approval
in all the countries it was
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going to be rolled out at, you
know, which included Australia
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and New Zealand, because that
had to happen before people got
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shots in arms. But here I was,
sort of in locked down, borders
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closed New Zealand, going well,
we're really lucky because we,
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we've managed to eliminate
COVID. But we cannot, we can't
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eliminate it forever. Like we
can't keep our borders closed
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and expect that it's not going
to happen. So we need a vaccine
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rollout. And we're going to have
it, you know, reasonably
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quickly, but there was this
delay occurring, and it made me
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wonder, why are we waiting for
like, why would New Zealand or
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even if we take Australia, why
would we think that we've got
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smarter people, okay, who can
look at this vaccine, and assess
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the risks at a higher level than
the most powerful economic
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nation on the planet that has
some of the brightest medical
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minds on the globe, who have
gone through it, presumably, and
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this is the assumption the FDA
have gone through it with a fine
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tooth comb, before they start
injecting 385 million Americans
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with it in a country where if
they get it wrong, the
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consequences can be horrific,
from a legal point of view,
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putting aside the social and the
health point of view. So why is
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it that New Zealand and
Australia feel that we need to
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go through and check these
things? You know, what am I
307
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missing? Yeah.
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Marco Rizzi: So that is a small
question.
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Chris Patterson: No no, sorry,
that went on for quite a while.
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I guess, why can't we just
rubber stamp. ..You know, if
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it's FDA approved, it's fine.
Let's all get it in us.
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Marco Rizzi: It's a fair point.
So okay, let me preface this by
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saying the approval of COVID
vaccine that was an emergency
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situation. So it's not what
normally happens, right? So your
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normal situation is I don't
know, you develop a new
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antidepressant or a new
anticoagulants or a new, I don't
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know, anti diabetes drug. And,
you know, it takes a certain
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amount of time, it takes
certain, normally years. And
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eventually it gets on the
market. And you can try to have
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bilateral agreements to
recognize tests, for example,
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clinical trials that are, you
know, performed abroad, instead
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of having to do them all
domestically. But anyway, to
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answer your question about the
COVID vaccines specifically...
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Chris Patterson: Or in fact, any
approval. Why couldn't we have a
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system where if it's approved by
the FDA, that's fine, you know,
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we don't need to go through this
regulatory...
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Marco Rizzi: Because not every
country has the same thresholds.
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And not every country accepts
the same trade offs between for
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example, speediness of
availability versus safety. Not
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every country is perfectly
comparable when it comes to for
331
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instance, the overall regulatory
system. So you talk about the
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FDA. So the FDA is arguably a
little bit more prone to approve
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products on a slightly lesser
risk utility evaluation. So the
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level of risk that is accepted
is a little bit higher. Part of
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this is linked to the fact that
the United States... If you look
336
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at the overall regulatory
regime, so not just the front
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end, the tests that you need to
undertake and the hoops you need
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to go through before you get the
product on the market, but you
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look at it holistically. So you
look, for instance, at the
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remedies available and the
courses of action available, the
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United States tends to have an
entrepreneurial class of
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litigators that put together big
class actions. Yeah, type of
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back end watchdog is a integral
parts to the overall regulatory
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model, which prompts the us
sometimes to make decisions on a
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risk utility analysis that is
different to the one that for
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example, you would have in
Europe, where access to courts
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and litigation is not at all as
easy as incentivised class
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actions aren't really available,
for example. And the problem is
349
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with therapeutic goods, you
really need class actions,
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because it's very hard for an
individual to say, this
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particular product calls me this
particular harm, it is much
352
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easier to if you aggregate a
class to say look at there's a
353
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pattern of these people have all
taken the drugs under certain
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circumstances. And compared to
like, you know, the general
355
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population, the incidence of
say, heart failure increases by
356
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a certain percentage, therefore,
you can make the inference that
357
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the adverse event is linked to
the drug, but you need to
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aggregate claims in order to do
that.
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Chris Patterson: Well, it's one
of those classic areas where why
360
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class actions work, because an
individual is not going going to
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have the resources to be able to
assert their rights. And it is
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that grouping that enables the
class action regime to work. I
363
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mean, New Zealand doesn't have a
class action regime, it's still
364
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using this ridiculous archaic
representative action. But at
365
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least Australia since I think
1998 has had at various state
366
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levels, a class action regime
that's worked quite well. I
367
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can't think of where the class
action regime has been applied
368
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against a pharmaceutical
company, but there may have been
369
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one. But I'll share a little fun
fact thought with it with you,
370
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Marco, and that is the great
sunny state of New South Wales
371
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is actually the most litigious
state on the planet Earth.
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Second only, okay, second only
to California. Okay. So that is
373
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on a per capita basis. That's a
little fun fact. But your points
374
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well made is that the the class
action regime and the lawyers
375
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who are class action lawyers act
as a bit of a watchdog to ensure
376
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that these companies are not
doing anything that or hopefully
377
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watching as another layer, that
these companies aren't producing
378
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products that are going to hurt
people.
379
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Marco Rizzi: Yeah. So I think
that the problem with
380
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therapeutic goods is that,
especially with drugs, it's very
381
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rare that a drug will have what
you call a signature adverse
382
00:27:25,740 --> 00:27:30,240
event. So one example a rare
example of that is the so the
383
00:27:30,840 --> 00:27:34,710
famous AstraZeneca vaccine had
that very, very, very, very
384
00:27:34,710 --> 00:27:40,500
small chance of causing a very,
very particular and a very rare
385
00:27:40,530 --> 00:27:46,380
type of thrombosis, which kind
of then sends the entire rollout
386
00:27:46,830 --> 00:27:49,680
out the window, essentially, of
that particular vaccine or
387
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whether or not that was
warranted is a different
388
00:27:51,690 --> 00:27:55,470
question. But the point is, that
was kind of what you would call
389
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potentially a signature harm.
Another example is, well, that's
390
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not a therapeutic good, but like
asbestos causes mesothelioma,
391
00:28:03,750 --> 00:28:08,010
that's a very kind of specific
type. So you're exposed to a
392
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certain substance, you suffer
from a certain adverse reaction.
393
00:28:13,200 --> 00:28:18,390
But by and large, what drugs do
is they don't have a signature
394
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effect. They don't have a
specific adverse events that
395
00:28:22,320 --> 00:28:25,740
they directly cause what they do
is they increase the chances of
396
00:28:25,770 --> 00:28:30,360
other stuff happening. So a
typical example was a good
397
00:28:30,360 --> 00:28:34,530
example was the Vioxx. So Vioxx
was this anti-arthritis drug
398
00:28:34,530 --> 00:28:38,550
produced by Merck. And in the
early 2000s, there was this huge
399
00:28:38,550 --> 00:28:42,450
class action in the United
States that showed that Vioxx
400
00:28:42,450 --> 00:28:47,190
basically increased
statistically, in a significant
401
00:28:47,190 --> 00:28:50,340
in a statistically significant
way increased the risk of heart
402
00:28:50,340 --> 00:28:53,730
failure. The problem is, if
you're an individual, it's very
403
00:28:53,730 --> 00:28:56,880
hard for you to say that it was
Vioxx that caused your heart
404
00:28:56,880 --> 00:28:59,640
failure as opposed to any other
stuff like I don't know, maybe
405
00:28:59,640 --> 00:29:02,310
you have hypertension, maybe you
have high cholesterol, you
406
00:29:02,310 --> 00:29:02,430
know...
407
00:29:02,790 --> 00:29:03,900
Chris Patterson: Maybe you're a
smoker.
408
00:29:04,080 --> 00:29:05,970
Marco Rizzi: Maybe a smoker,
maybe you drink too much
409
00:29:05,970 --> 00:29:07,380
whatever, like, you know,
there's...
410
00:29:07,800 --> 00:29:09,000
Chris Patterson: It might even
just be genetic.
411
00:29:09,690 --> 00:29:13,560
Marco Rizzi: Oh, yeah. So it is
very difficult. However, if you
412
00:29:13,560 --> 00:29:18,030
aggregate the number of people
who do take the drug, and you
413
00:29:18,030 --> 00:29:23,640
can show a pattern, then that
is, you know, that increases the
414
00:29:23,640 --> 00:29:29,700
chances of a court being
satisfied that the cause because
415
00:29:29,700 --> 00:29:32,550
at the end of the day, so the
question of causation, really,
416
00:29:33,180 --> 00:29:36,840
that it is indeed the product
that caused the harm, and then
417
00:29:36,840 --> 00:29:40,140
that can therefore trigger
later. Yeah, I mean, most of
418
00:29:40,140 --> 00:29:43,560
these things then get settled
out of court. Right? So Vioxx
419
00:29:43,680 --> 00:29:47,460
settled for billions of dollars
out of court, because when you
420
00:29:47,460 --> 00:29:51,450
see that the huge companies when
they see that the case might be
421
00:29:51,450 --> 00:29:54,720
going south, they have an
interest that their interest is
422
00:29:54,720 --> 00:30:00,390
in settling because you don't
want to create a precedent. But
423
00:30:00,420 --> 00:30:05,160
it is true that aggregating
claims, certainly increases the
424
00:30:05,160 --> 00:30:11,490
chances of uncovering potential
risks that only emerge in the
425
00:30:11,490 --> 00:30:13,500
aggregate than not in individual
cases.
426
00:30:13,810 --> 00:30:17,080
Chris Patterson: And they're
also after the effect, you know,
427
00:30:17,080 --> 00:30:22,420
whereas the FDA, the TGA in
Australia, you know, the
428
00:30:22,420 --> 00:30:26,230
processes are in place here to
try and avoid this harm
429
00:30:26,230 --> 00:30:29,320
occurring. And then you look,
you've reminded me, I mean,
430
00:30:29,320 --> 00:30:32,770
we're going back quite a long
way in time. I mean, I think it
431
00:30:32,770 --> 00:30:37,930
was the 1950s, or 60s, but there
was a, there was a medication
432
00:30:37,960 --> 00:30:43,840
for women who was suffering from
morning sickness thalidomide and
433
00:30:44,140 --> 00:30:48,790
that had a secondary, very
adverse effect to their unborn
434
00:30:48,790 --> 00:30:52,000
children, you know, someone will
end up not having sort of limbs
435
00:30:52,000 --> 00:30:55,630
or deformed limbs as a result,
you know, but presumably, that's
436
00:30:55,630 --> 00:31:00,460
another example of a drug that's
gone through regulatory testing
437
00:31:00,460 --> 00:31:04,000
and all of that process. Yet,
unfortunately, it's been
438
00:31:04,000 --> 00:31:07,540
released into the open market
and marketed to consumers who
439
00:31:07,540 --> 00:31:10,750
have used it, and it's resulted
in harm. And that's where the
440
00:31:10,750 --> 00:31:11,770
system collapses,.
441
00:31:11,810 --> 00:31:14,060
Marco Rizzi: Actually, it's
interesting, you make this
442
00:31:14,060 --> 00:31:19,370
example. So regulation of
therapeutic goods of medicines
443
00:31:19,370 --> 00:31:23,270
in general is not, it's a
relatively historically recent
444
00:31:23,270 --> 00:31:27,800
phenomenon. So it started in the
US in the early 20th century on
445
00:31:27,800 --> 00:31:33,260
the back of a, what you would
call a drug disaster. So it was
446
00:31:33,260 --> 00:31:37,460
a cough medication that was
imported from Germany. And then
447
00:31:37,460 --> 00:31:41,960
in the US, what the importers
tried to do was, they wanted to
448
00:31:41,960 --> 00:31:47,270
turn it into a syrup. And they
mixed it with a solvent that was
449
00:31:47,270 --> 00:31:51,140
highly toxic. And as a result of
this, it was called
450
00:31:51,140 --> 00:31:54,860
sulfanilamide. And as a result
of this, a number of a number of
451
00:31:54,860 --> 00:31:58,070
people died, a number of people
had a huge adverse event. And
452
00:31:58,070 --> 00:32:00,800
that is what prompted the
creation of the regulatory
453
00:32:00,800 --> 00:32:04,040
regime, the Food and Drug
Administration and the idea that
454
00:32:04,040 --> 00:32:09,110
you need before you distribute a
product that has a therapeutic
455
00:32:09,500 --> 00:32:12,290
impact that wants to have a
therapeutic impact before you
456
00:32:12,320 --> 00:32:15,200
distribute that into the general
population, you need to test it.
457
00:32:16,160 --> 00:32:21,530
That led the US to in the 50s
and 60s, as you say, not approve
458
00:32:21,530 --> 00:32:26,780
thalidomide for distribution in
the United States, which is why
459
00:32:26,960 --> 00:32:30,140
there's been a very just a
handful of cases of people who
460
00:32:30,140 --> 00:32:33,620
got their hands on thalidomide
in the United States, whereas in
461
00:32:33,620 --> 00:32:37,370
Europe, it was a disaster,
particularly in Germany. And the
462
00:32:37,370 --> 00:32:41,990
thalidomide crisis is what
prompted the European community
463
00:32:41,990 --> 00:32:46,280
at the time to start developing
strong regulatory, free
464
00:32:46,280 --> 00:32:51,020
marketing, authorization
procedures, which didn't exist
465
00:32:51,020 --> 00:32:54,800
at the time. So at the time, it
was quite loosely regulated. But
466
00:32:54,830 --> 00:32:58,640
on the back of thalidomide, that
is when the whole thing started
467
00:32:58,640 --> 00:33:05,270
properly. And I think that's
also where medical products,
468
00:33:05,300 --> 00:33:10,520
medicines and pharmaceuticals,
started to take their own path
469
00:33:10,550 --> 00:33:15,980
in terms of and kind of split up
from general goods, and become
470
00:33:15,980 --> 00:33:20,450
their own kind of special
category that has these special
471
00:33:20,450 --> 00:33:25,490
regimes that require thorough
testing before they are
472
00:33:25,490 --> 00:33:28,760
distributed. So every drug has
to undergo clinical trials,
473
00:33:28,760 --> 00:33:33,710
right. And a clinical trial is a
test in which I don't know if
474
00:33:33,740 --> 00:33:37,730
you know how that works. But
essentially, the principle of
475
00:33:37,730 --> 00:33:41,960
double blind clinical trials is
you have scientists who don't
476
00:33:41,960 --> 00:33:44,810
know you have a group of
scientists, and then you have
477
00:33:44,810 --> 00:33:48,200
two groups of people, two groups
of patients, one group gets the
478
00:33:48,410 --> 00:33:53,450
experimental drug, one group
gets a placebo. Nobody knows
479
00:33:53,450 --> 00:33:56,630
what they're getting. And the
scientists themselves don't know
480
00:33:56,840 --> 00:33:59,150
which group is getting what,
then there is obviously a
481
00:33:59,150 --> 00:34:03,800
coordinator that knows all that
otherwise it's random. And the
482
00:34:03,800 --> 00:34:06,950
idea is that once you've
undergone the whole, the
483
00:34:06,950 --> 00:34:10,820
treatment course, you look at
the two groups, and you make an
484
00:34:10,820 --> 00:34:14,240
assessment of safety and
efficacy. So you look at the
485
00:34:14,240 --> 00:34:17,750
group who receive the
experimental drug, and you see
486
00:34:17,750 --> 00:34:20,840
whether therapeutically, there
is an improvement compared to
487
00:34:20,840 --> 00:34:23,510
the placebo. And then you look
at whether there are side
488
00:34:23,510 --> 00:34:26,330
effects compared to the group
that got the placebo. And that's
489
00:34:26,660 --> 00:34:29,300
that, in a nutshell, that's how
you make the assessment. And
490
00:34:29,300 --> 00:34:32,330
then their clinical development
requires you to do clinical
491
00:34:32,330 --> 00:34:36,200
trials on increasingly big,
there's three stages. And the
492
00:34:36,200 --> 00:34:42,080
third stage is on 10s of 1000s
of people, right? So but the 60s
493
00:34:42,080 --> 00:34:44,510
and the thalidomide crisis is
really the breaking point in
494
00:34:44,510 --> 00:34:50,090
which governments around the
world are like realize that as
495
00:34:50,090 --> 00:34:54,830
medicines become mass consumed
goods, you do need to have some
496
00:34:54,830 --> 00:35:00,020
special systems in place to
ensure that once they reach a
497
00:35:00,020 --> 00:35:04,640
broad consumer market, they are
as safe and effective as you can
498
00:35:04,640 --> 00:35:09,740
possibly get them to be. Knowing
that there is no such thing as
499
00:35:09,770 --> 00:35:10,490
risk free.
500
00:35:11,390 --> 00:35:13,100
Chris Patterson: Now I want to
stay on the topic of medicines,
501
00:35:13,100 --> 00:35:16,190
we will get into goods. But
let's just stay on the topic of
502
00:35:16,190 --> 00:35:19,670
medicines for a second. So there
I understand is an Australian
503
00:35:19,670 --> 00:35:25,370
register of therapeutic goods.
That registers medicines into
504
00:35:25,370 --> 00:35:28,700
three categories, one being a
registered medicine, second
505
00:35:28,700 --> 00:35:33,320
being a listed medicine. And the
third one being an assessed list
506
00:35:33,320 --> 00:35:37,010
of medicine, are you able to
kind of walk us through those
507
00:35:37,010 --> 00:35:37,940
three categories?
508
00:35:39,380 --> 00:35:42,410
Marco Rizzi: Yeah, so
essentially, the three
509
00:35:42,410 --> 00:35:48,050
categories that they, I don't
want to get into too many
510
00:35:48,050 --> 00:35:55,220
details, but to make it
essentially, what this means is
511
00:35:55,220 --> 00:36:00,590
that you have three different
levels of a thoroughness of
512
00:36:00,590 --> 00:36:04,130
review. So the registered ones
are the ones that have gone
513
00:36:04,130 --> 00:36:08,630
through the whole, the full
review, and...
514
00:36:08,840 --> 00:36:10,760
Chris Patterson: Like double
blind testing?
515
00:36:10,930 --> 00:36:13,660
Marco Rizzi: Well no, they all
have to, they kind of all have
516
00:36:13,660 --> 00:36:18,610
to but like, there may be
certain certain medicines that
517
00:36:21,940 --> 00:36:28,660
that are available to physicians
under certain conditions,
518
00:36:31,000 --> 00:36:35,770
without having been fully
reviewed or approved. So, for
519
00:36:35,770 --> 00:36:43,120
example, the fact is that you do
have, you do have situations
520
00:36:43,150 --> 00:36:48,880
that may warrant patients
receiving drugs that aren't
521
00:36:48,880 --> 00:36:53,740
fully approved, or drugs that
aren't fully reviewed. So that's
522
00:36:53,770 --> 00:36:57,040
what you call the compassionate
use, okay, and the compassionate
523
00:36:57,040 --> 00:37:03,550
use allows physicians to
distribute or to prescribe drugs
524
00:37:03,550 --> 00:37:07,690
to patients that have not been
yet fully registered in the
525
00:37:07,690 --> 00:37:10,840
ARTG, so in the Australian
Register for Therapeutic Goods.
526
00:37:11,230 --> 00:37:15,400
That is, for example, when
someone is terminally ill, or
527
00:37:15,400 --> 00:37:19,000
someone has like a particularly
aggressive disease for which
528
00:37:19,000 --> 00:37:22,600
there is no other non
therapeutic course of action. So
529
00:37:22,600 --> 00:37:26,500
that's one thing, in terms of
the various levels of license or
530
00:37:26,500 --> 00:37:30,250
register of registration that
are available in therapeutic
531
00:37:30,250 --> 00:37:33,520
goods, it's a combination of
availability under certain
532
00:37:33,520 --> 00:37:39,430
circumstances and risk factor.
So certain medicines warrant may
533
00:37:39,430 --> 00:37:45,730
require a lesser level of of
review in order for Australian
534
00:37:45,730 --> 00:37:48,430
authorities to approve them for
distribution. So it's kind of a
535
00:37:48,430 --> 00:37:54,430
technical differentiation, it is
not, I would say, at its core,
536
00:37:54,850 --> 00:37:59,920
any drug that goes into the just
to make the broader point, any
537
00:37:59,920 --> 00:38:02,440
drug that gets into the
Australian register of therapy,
538
00:38:02,440 --> 00:38:07,000
the good has to have been
reviewed by the Therapeutic
539
00:38:07,000 --> 00:38:09,880
Goods Administration, and then
the level of review may vary.
540
00:38:10,210 --> 00:38:11,800
Chris Patterson: Okay. And
Marco, you made an interesting
541
00:38:11,800 --> 00:38:14,440
point to sort of earlier on and
I wanted to pick up and that as
542
00:38:15,340 --> 00:38:18,880
before it goes to the its
registered list, and it's gone
543
00:38:18,880 --> 00:38:21,070
through all the checking and all
of that, of course, you know,
544
00:38:21,070 --> 00:38:26,860
when drugs are being, you know,
developed, the pharmaceutical
545
00:38:26,890 --> 00:38:29,860
companies themselves or the
inventors are going to need to
546
00:38:30,160 --> 00:38:34,900
do their own testing. Is there a
license requirement that they
547
00:38:34,900 --> 00:38:41,020
need to obtain from the TGA? Or
anyone else? Or can they
548
00:38:41,020 --> 00:38:45,580
literally just produce a new
chemical compound and start
549
00:38:45,580 --> 00:38:47,080
applying it to patients?
550
00:38:47,890 --> 00:38:51,700
Marco Rizzi: No, there are. So
every country has different
551
00:38:52,360 --> 00:39:01,120
types of legislation. But by and
large, this has been
552
00:39:01,360 --> 00:39:05,620
internationally harmonized. So
there is a regulatory network
553
00:39:05,620 --> 00:39:10,360
called the International
Conference on Harmonization for
554
00:39:11,230 --> 00:39:14,290
the Regulation of Pharmaceutical
Products for Human Use. It's a
555
00:39:14,290 --> 00:39:16,360
bit of a mouthful, but basically
it's...
556
00:39:16,990 --> 00:39:18,370
Chris Patterson: For drug
trials, you know, and...
557
00:39:18,360 --> 00:39:22,149
Marco Rizzi: Yeah, it's called
ICH, International Conference on
558
00:39:22,225 --> 00:39:26,393
Harmonization. It's abbreviated
as ICH and what they've
559
00:39:26,469 --> 00:39:30,713
developed, among many other
things is what's called Good
560
00:39:30,789 --> 00:39:35,639
Clinical Practice. Good Clinical
Practice is a set of rules that
561
00:39:35,715 --> 00:39:39,807
you need to as as a, as a
sponsor, so manufacturer for
562
00:39:39,883 --> 00:39:44,658
example of a new of a new drug.
There's a set of rules that you
563
00:39:44,733 --> 00:39:49,584
need to follow for the clinical
trial to be ethically conducted.
564
00:39:49,659 --> 00:39:54,586
So and ethically conducted means
that you always have to have the
565
00:39:54,661 --> 00:39:59,436
best interests of the patients
at heart right so you're not the
566
00:39:59,512 --> 00:40:03,832
point what would you want to
void is situations like, you
567
00:40:03,907 --> 00:40:08,606
know, the Nazi type of testing
of using humans as guinea pigs.
568
00:40:08,682 --> 00:40:12,774
So there's a set of rules
underpinning clinical trials
569
00:40:12,850 --> 00:40:16,943
that are quite stringent. And
they are internationally
570
00:40:17,019 --> 00:40:21,111
adopted. And they've been
developed at this ICH, under
571
00:40:21,187 --> 00:40:25,203
ICH, which is a consortium of
regulators and industry
572
00:40:25,279 --> 00:40:29,978
representatives. Then there's
separate instruments such as the
573
00:40:30,054 --> 00:40:34,525
Helsinki Declaration that,
obviously is an international is
574
00:40:34,601 --> 00:40:38,542
a is a is an international
document that essentially
575
00:40:38,618 --> 00:40:43,013
outlines what the limitations
are for anyone who wishes to
576
00:40:43,089 --> 00:40:47,864
undertake research that involves
human participants. So there's
577
00:40:47,940 --> 00:40:52,259
ethical limitations that are
quite stringent. So it's not
578
00:40:52,335 --> 00:40:56,049
like you can just take a
molecule and go and just
579
00:40:56,125 --> 00:41:00,748
distributed and see there's like
very, very heavily regulated
580
00:41:00,823 --> 00:41:05,219
protocols on what kind of
structures you need to have what
581
00:41:05,295 --> 00:41:09,918
kind of systems need to be in
place. What kind of protections
582
00:41:09,994 --> 00:41:14,162
for the patients that are
involved need to be in place,
583
00:41:14,238 --> 00:41:18,785
etc. So it's not, no no, it's
not like it's not like the TGA
584
00:41:18,861 --> 00:41:23,180
will accept any kind of data
that comes with no questions
585
00:41:23,256 --> 00:41:27,652
asked, like the data needs to
have needs to be gathered in
586
00:41:27,728 --> 00:41:32,123
observance, observing certain
stringent protocols that are
587
00:41:32,199 --> 00:41:34,170
internationally regulated.
588
00:41:34,570 --> 00:41:38,080
Chris Patterson: Yeah, I've been
reading Michael Pollan's book
589
00:41:38,110 --> 00:41:42,340
called How to Change Your Mind,
which sort of you familiar with
590
00:41:42,340 --> 00:41:45,850
the book? He's kind of delved
into the history of the
591
00:41:46,300 --> 00:41:47,860
psychedelic drugs.
592
00:41:47,950 --> 00:41:48,580
Marco Rizzi: Ah yeah.
593
00:41:49,030 --> 00:41:53,560
Chris Patterson: And then in his
book, he, he provides a great
594
00:41:53,590 --> 00:41:59,020
narration of the clinical
research into areas like LSD and
595
00:41:59,020 --> 00:42:04,240
MDMA, psilocybin, or in the lead
up to the early 70s, with the
596
00:42:04,240 --> 00:42:08,620
war on drugs that then made them
prohibited products or product
597
00:42:08,620 --> 00:42:12,610
prohibited compounds to possess
and use and they have brought
598
00:42:12,610 --> 00:42:16,930
that whole research area to a
grinding halt, at least in the
599
00:42:16,930 --> 00:42:21,730
US and Canada. Although, from
what I understand now, having
600
00:42:21,730 --> 00:42:25,810
looked at in a bit more detail,
university hospitals like John
601
00:42:25,810 --> 00:42:29,980
Hopkins, etc. are now doing
quite large double blind
602
00:42:30,160 --> 00:42:34,870
research into the therapeutic
benefits of some of these, some
603
00:42:34,870 --> 00:42:38,440
of these drugs, and the data
that's coming out of it,
604
00:42:38,440 --> 00:42:41,800
particularly around areas for
treating anxiety and depression,
605
00:42:41,860 --> 00:42:47,590
and seems to be quite promising.
But again, I mean, presumably,
606
00:42:47,590 --> 00:42:53,590
at some point in time, if they
can get off the prohibited list
607
00:42:53,590 --> 00:42:58,000
as effectively narcotics, they
could then be used as medicines.
608
00:42:58,630 --> 00:42:59,710
I guess that's the pathway.
609
00:42:59,930 --> 00:43:04,070
Marco Rizzi: Yeah, no, that's,
that's, I think the key is you,
610
00:43:04,070 --> 00:43:07,160
as you were saying, the key is
how, how you do these
611
00:43:07,160 --> 00:43:10,760
experiments, right. So one of
the one of the things that were
612
00:43:10,850 --> 00:43:14,510
a bit horrible about the way in
which LSD was, was used in the,
613
00:43:14,510 --> 00:43:20,420
you know, 60s 70s. There was
literally a, I mean, I mentioned
614
00:43:20,420 --> 00:43:23,300
it, the Nazi regime, but of
course, the Nazis were not the
615
00:43:23,300 --> 00:43:29,150
only ones who historically have
used humans as guinea pigs to,
616
00:43:29,180 --> 00:43:33,650
you know, test the effects of
certain of certain compounds on
617
00:43:33,680 --> 00:43:41,690
on, on humans. I think that that
whole research into LSD and
618
00:43:41,720 --> 00:43:48,560
other psychedelic drugs was
tainted by that background of
619
00:43:49,580 --> 00:43:54,260
essentially, unethical
experimentation that happened
620
00:43:54,830 --> 00:44:02,420
decades ago. And that has really
set the research back decades
621
00:44:02,450 --> 00:44:07,610
for decades, because actually,
now that these types of studies
622
00:44:07,610 --> 00:44:12,230
are being conducted ethically,
so observing the ethical
623
00:44:12,230 --> 00:44:15,080
principles of the Declaration of
Helsinki, and following the good
624
00:44:15,080 --> 00:44:19,340
clinical practice guidelines.
But then, of course, you start
625
00:44:19,340 --> 00:44:22,910
seeing that, you know, there, as
you say, there may be some
626
00:44:22,910 --> 00:44:27,530
positive therapeutic effects
when it comes to the treatment
627
00:44:27,530 --> 00:44:29,990
of certain mental diseases.
628
00:44:30,200 --> 00:44:32,120
Chris Patterson: So,
particularly when it's being
629
00:44:32,120 --> 00:44:34,910
done properly, because I mean,
from what, yeah, because what I
630
00:44:34,910 --> 00:44:35,630
understand is...
631
00:44:36,140 --> 00:44:39,500
Marco Rizzi: But that's the key,
right? The key is that, and it
632
00:44:39,500 --> 00:44:41,870
goes back to your earlier
question as to you know, how do
633
00:44:41,870 --> 00:44:46,730
you do this? Well, there are
very heavily regulated
634
00:44:46,730 --> 00:44:51,980
protocols, that anyone who
engages in clinical research
635
00:44:51,980 --> 00:44:58,100
needs to follow. And the reality
is that if you don't that, you
636
00:44:58,100 --> 00:45:02,240
know, can expose you to
liability, civil but criminal as
637
00:45:02,240 --> 00:45:07,160
well. But more, even if we
simply focus on the process that
638
00:45:07,160 --> 00:45:10,040
leads to the approval of the
therapeutic goods, it prevents
639
00:45:10,040 --> 00:45:12,830
the approval from happening
because if the data that is
640
00:45:12,830 --> 00:45:18,440
gathered is not gathered
properly, that data cannot be
641
00:45:18,440 --> 00:45:22,460
used for the purpose of issuing
an authorization for
642
00:45:22,460 --> 00:45:26,510
distribution. So it is, it is in
the interest of the companies if
643
00:45:26,510 --> 00:45:31,670
you want as well to follow, to
follow the protocols and to
644
00:45:31,670 --> 00:45:35,540
follow the proper processes
because otherwise that prevent
645
00:45:35,540 --> 00:45:39,470
that kind of has a negative
impact on on their investments,
646
00:45:39,470 --> 00:45:42,530
because they're going to be able
to distribute a product that
647
00:45:42,530 --> 00:45:44,480
wasn't appropriately tested.
648
00:45:45,080 --> 00:45:46,370
Chris Patterson: Well, yeah. And
of course, there's a lot of
649
00:45:46,400 --> 00:45:49,610
money at stake because they pump
a lot of money into into
650
00:45:49,610 --> 00:45:53,120
research, the product's not
worth anything unless it can get
651
00:45:53,120 --> 00:45:56,390
approval and then be marketed
and sold. So that's...
652
00:45:56,000 --> 00:45:59,360
Marco Rizzi: That's not to say
that's not to say that there
653
00:45:59,360 --> 00:46:02,930
isn't like there are moral
hazards occurring, there are,
654
00:46:00,860 --> 00:47:23,000
How are you feeling? Are you
feeling okay?
655
00:46:03,950 --> 00:46:07,430
you know, there are situations
in which, you know, companies
656
00:46:07,430 --> 00:46:09,710
have cut corners. So, for
instance, I was talking about
657
00:46:09,710 --> 00:46:12,980
the Vioxx case earlier on that
is a case in which America
658
00:46:12,980 --> 00:46:18,590
basically did not disclose a
study that they had there that
659
00:46:18,590 --> 00:46:24,860
they were aware of, for years
before, actually, the class
660
00:46:24,860 --> 00:46:30,860
action for heart failure was
started. And one of the points
661
00:46:31,040 --> 00:46:33,980
that was made was that they were
aware of certain side effects,
662
00:46:33,980 --> 00:46:36,650
and they didn't disclose them.
So it's not like, you know, I'm
663
00:46:36,650 --> 00:46:39,740
not trying to make the point
that, you know, everyone behaves
664
00:46:39,980 --> 00:46:44,240
impeccably, but because they
don't, and that's just human
665
00:46:44,240 --> 00:46:48,140
nature, otherwise, we wouldn't
need laws and regulations. But
666
00:46:48,920 --> 00:46:51,680
but this is to say, but I just
wanted to say that they have
667
00:46:51,680 --> 00:46:55,220
quite strong protocols, and
particularly when it comes to
668
00:46:55,220 --> 00:46:59,660
pharmaceutical products and
vaccines. They are very
669
00:46:59,660 --> 00:47:03,410
stringent. And they are some of
these are some of the most
670
00:47:03,410 --> 00:47:08,180
regulated and the most monitored
products that we that we use. So
671
00:47:08,180 --> 00:47:13,100
when when when authorities say
something is safe, I think it's
672
00:47:13,100 --> 00:47:16,640
important to recognize that safe
doesn't mean risk free, but it
673
00:47:16,640 --> 00:47:19,850
is overall safe. And it has
undergone through a very
674
00:47:19,850 --> 00:47:22,640
thorough process of testing,
including, you know, you were
675
00:47:22,640 --> 00:47:25,370
talking about the fact that you
had three shots of the COVID
676
00:47:23,000 --> 00:47:34,340
Yeah yeah, just a bit of a sore
arm for a couple of days, but
677
00:47:25,370 --> 00:47:28,790
vaccine vaccine, I just very
recently had my fourth one,
678
00:47:29,180 --> 00:47:29,720
COVID vaccine...
679
00:47:34,340 --> 00:47:39,050
nothing, nothing more than that.
But it is important to note that
680
00:47:39,050 --> 00:47:42,800
you know, these are safe. But
safe doesn't mean risk free,
681
00:47:42,800 --> 00:47:46,100
which is why it is you know that
that needs to be acknowledged, I
682
00:47:46,100 --> 00:47:48,830
think because especially when
you are trying to roll out
683
00:47:48,830 --> 00:47:55,310
something as widely as a
vaccine, it is the risk of side
684
00:47:55,310 --> 00:47:58,310
effects obviously increases
because it's not like a targeted
685
00:47:58,310 --> 00:48:01,070
medicine that you're only going
to give to a certain segment of
686
00:48:01,070 --> 00:48:04,250
the population, you're giving it
to everyone. When you do it,
687
00:48:04,250 --> 00:48:07,670
when you do give something to
everyone, the risk of something
688
00:48:07,700 --> 00:48:12,560
going wrong obviously increases.
Which is why you know, it's
689
00:48:12,560 --> 00:48:14,870
important to have systems in
place like you know,
690
00:48:14,870 --> 00:48:20,930
compensation plans and other
such remedial. So I think you
691
00:48:20,930 --> 00:48:23,240
know, struggling I think in New
Zealand, you're using your you
692
00:48:23,240 --> 00:48:25,640
have a general accident
compensation plan...
693
00:48:26,810 --> 00:48:29,870
Chris Patterson: In New Zealand,
and I believe it to be the case,
694
00:48:29,870 --> 00:48:33,470
we've got a unique system that
hasn't been replicated anywhere
695
00:48:33,470 --> 00:48:37,070
else in the world. Now either
we're onto something that no one
696
00:48:37,070 --> 00:48:43,190
else has been able to click on
to how genius this is, or it's
697
00:48:43,190 --> 00:48:48,260
horribly wrong. Because no one
else will do it. But yeah, so we
698
00:48:48,260 --> 00:48:52,640
have a no fault accident
compensation regime, which
699
00:48:52,640 --> 00:48:54,830
applies to medical malpractice
as well. So...
700
00:48:55,430 --> 00:48:57,740
Marco Rizzi: And it would apply
to and it would apply to, you
701
00:48:57,740 --> 00:49:02,810
know, COVID vaccine related
injuries.
702
00:49:03,380 --> 00:49:05,810
Chris Patterson: Which makes New
Zealand probably the best
703
00:49:05,810 --> 00:49:11,210
jurisdiction in the world to
test stuff, knowing that you
704
00:49:11,210 --> 00:49:12,080
can't get sued.
705
00:49:12,000 --> 00:49:16,020
Marco Rizzi: You but no, but
actually, it's interesting you
706
00:49:16,020 --> 00:49:19,260
make that point because in
Australia, Australia doesn't did
707
00:49:19,260 --> 00:49:22,440
not have any no fault
compensation plan whatsoever for
708
00:49:22,440 --> 00:49:27,240
any product, making it by the
way, an outlier in OECD
709
00:49:27,240 --> 00:49:29,910
countries, because most OECD
countries have some form of no
710
00:49:29,910 --> 00:49:32,880
fault compensation plan,
particularly for vaccines. Okay,
711
00:49:32,880 --> 00:49:36,270
so, because the idea is it's you
know, it's the idea of the basic
712
00:49:36,270 --> 00:49:41,130
idea of mutualism. You know, I
ask everyone to do something
713
00:49:41,130 --> 00:49:44,130
which protects them but also
protects the general community.
714
00:49:44,460 --> 00:49:48,450
So I need to be able to protect
the individual. So the in the
715
00:49:48,450 --> 00:49:52,920
rare rare event of something
going wrong for an individual, I
716
00:49:52,920 --> 00:49:55,560
need to give them some form of
safety net.
717
00:49:55,000 --> 00:49:58,270
Chris Patterson: It's almost
like a social contract, isn't
718
00:49:58,000 --> 00:49:59,500
Marco Rizzi: Yeah, no, exactly.
And Australia was a noticeable
719
00:49:58,270 --> 00:49:58,420
it?
720
00:49:59,500 --> 00:50:01,300
outlier in not having any such
thing. So New Zealand has done
721
00:50:01,330 --> 00:50:08,740
it, you know, it's the it's the
other extreme, you have to know
722
00:50:09,130 --> 00:50:13,660
for compensation for any
accident. So, Australia has
723
00:50:13,660 --> 00:50:22,780
developed as a bespoke specific
COVID-19 Vaccine Claim Scheme,
724
00:50:22,810 --> 00:50:28,180
it's called. And it is there
precisely because, you know,
725
00:50:28,630 --> 00:50:32,980
it's been rolled out massively,
it's been mandated by a number
726
00:50:32,980 --> 00:50:38,590
of states in a number of for a
number of professions. WA, where
727
00:50:38,590 --> 00:50:42,880
I am Western Australia had
passed one of the smallest one
728
00:50:42,880 --> 00:50:46,450
of the strangest mandatory
vaccination policies in the
729
00:50:46,450 --> 00:50:51,400
world like 75, it was mandated
for 75% of the workforce, which
730
00:50:51,400 --> 00:50:56,620
is quite extraordinary. And so
of course, you need to have some
731
00:50:56,620 --> 00:51:02,440
kind of safety net, because you
need to be able to give back if
732
00:51:02,440 --> 00:51:07,000
someone has an injury. But back
to the point you made, which is,
733
00:51:07,720 --> 00:51:11,800
you can't get sued. Well,
actually, even before Australia
734
00:51:11,800 --> 00:51:14,200
implemented a no fault
compensation schemes company
735
00:51:14,200 --> 00:51:16,090
could not be sued, because that
was in the procurement
736
00:51:16,090 --> 00:51:20,890
contracts. So, you know,
Australia being one of the vast
737
00:51:20,890 --> 00:51:24,580
majority of countries in the
world that did not produce these
738
00:51:24,580 --> 00:51:28,750
vaccines. So we had a production
site for the AstraZeneca one,
739
00:51:28,960 --> 00:51:32,590
but that quickly went out the
window because the vaccine, the
740
00:51:32,590 --> 00:51:36,760
rollout of the AstraZeneca
vaccine was stopped due to the
741
00:51:36,880 --> 00:51:42,220
concerns around the thrombosis
side effect. But we don't
742
00:51:42,220 --> 00:51:46,240
produce mRNA vaccines like the
Pfizer one, the modern one. And
743
00:51:46,240 --> 00:51:47,410
so we have to import them.
744
00:51:48,250 --> 00:51:50,320
Chris Patterson: I think they
produced in India, that's what I
745
00:51:50,320 --> 00:51:52,720
understood. A lot of them are.
746
00:51:51,930 --> 00:51:54,951
Marco Rizzi: They were mostly
produced in the United States,
747
00:51:55,015 --> 00:51:58,551
and some in Europe. And I think
now the production, the
748
00:51:58,615 --> 00:52:02,151
production is scaling up. And
when you need to scale up
749
00:52:02,215 --> 00:52:05,751
production, you have to go to
countries like India, for
750
00:52:05,815 --> 00:52:09,737
example. Because, well, first of
all, they have a very highly
751
00:52:09,801 --> 00:52:13,337
developed pharmaceutical
industry. So they do have kind
752
00:52:13,401 --> 00:52:17,580
of the facilities. But also, you
just can't do it in one country.
753
00:52:17,644 --> 00:52:21,501
Like even if it's the United
States, if you need billions of
754
00:52:21,565 --> 00:52:25,165
people to be vaccinated, you
can't do it there. It's too
755
00:52:25,230 --> 00:52:29,151
expensive. It's too and there's
also the capacity is limited.
756
00:52:29,215 --> 00:52:32,815
But the interesting thing is
Australia, like pretty much
757
00:52:32,880 --> 00:52:35,965
every other country that
imported mRNA vaccines,
758
00:52:36,030 --> 00:52:40,080
introduced liability exemptions
from liability clauses in their
759
00:52:40,144 --> 00:52:43,744
contracts and the procurement
contracts, all had clauses
760
00:52:43,808 --> 00:52:47,794
whereby if something went wrong,
and individuals started suing
761
00:52:47,858 --> 00:52:52,230
for injury, the government would
pay the bill, not the manufacturer.
762
00:52:52,000 --> 00:52:55,990
Chris Patterson: So now...since
the government was indemnifying,
763
00:52:56,140 --> 00:52:58,120
the pharmaceutical companies
against liability.
764
00:52:58,000 --> 00:53:00,580
Marco Rizzi: Yeah, and so I
think the no fault compensation
765
00:53:00,580 --> 00:53:03,010
plan is like a step forward,
like okay, well, if the
766
00:53:03,010 --> 00:53:05,830
government is going to foot the
bill, you might as well remove
767
00:53:05,830 --> 00:53:08,620
the element of litigation and
having to prove the fact and
768
00:53:08,620 --> 00:53:12,670
fault or whatever you need to
prove under in. So negligence
769
00:53:12,670 --> 00:53:15,370
claims for therapeutic goods are
almost impossible, because
770
00:53:15,370 --> 00:53:19,030
proving that a manufacturer was
at fault, is really diabolical,
771
00:53:19,030 --> 00:53:22,450
there's too much of an asymmetry
of information between consumers
772
00:53:22,450 --> 00:53:25,900
and patients and manufacturers.
So which is why we have consumer
773
00:53:25,900 --> 00:53:29,320
laws that include normally
things like product liability,
774
00:53:29,650 --> 00:53:32,770
product liability is is a strict
liability regime where what you
775
00:53:32,770 --> 00:53:36,100
have to show is that the product
is defective. So it's below the
776
00:53:36,130 --> 00:53:39,820
safety that the public and
generally is generally entitled
777
00:53:39,820 --> 00:53:44,290
to expect. And there is a causal
link between the harm and the
778
00:53:44,290 --> 00:53:52,210
defect. Now, the problem there
is that proving that a vaccine
779
00:53:52,210 --> 00:53:57,520
is defective, is almost as
diabolical, diabolically hard as
780
00:53:57,520 --> 00:54:01,090
proving that a manufacturer is
at fault. And so what no fault
781
00:54:01,090 --> 00:54:05,350
compensations plan do is that
they remove the requirement to
782
00:54:05,350 --> 00:54:07,870
prove that a vaccine was
defective. And all you have to
783
00:54:07,870 --> 00:54:10,840
show is that you took the
vaccine and that you had an
784
00:54:10,840 --> 00:54:14,110
adverse event that was linked to
the vaccine. And then some
785
00:54:14,110 --> 00:54:19,540
plans, like the New Zealand one,
I think, and certainly others
786
00:54:20,830 --> 00:54:25,060
around the world are open ended.
Okay. So you have to make
787
00:54:25,060 --> 00:54:28,900
essentially, you have to make a
case that on a balance of
788
00:54:28,900 --> 00:54:31,720
probabilities, but it's not as
stringent as the civil
789
00:54:32,950 --> 00:54:35,920
requirements, you know. So in a
negligence claim, you have to
790
00:54:35,920 --> 00:54:38,560
make the case that on the
balance of probabilities, the
791
00:54:38,560 --> 00:54:43,210
breach of the defendant caused
the harm. In these situations,
792
00:54:43,210 --> 00:54:46,720
it's more of a you have to make
a prima facie case that the
793
00:54:46,720 --> 00:54:52,210
vaccine caused you harm. But
other countries like Australia,
794
00:54:52,240 --> 00:54:54,610
on the other hand, adopt a
different type of approach,
795
00:54:54,610 --> 00:54:58,840
which is a closed list. Of
course it's a list that is that
796
00:54:58,840 --> 00:55:04,660
gets updated as new data comes
in. But essentially, if you can
797
00:55:04,660 --> 00:55:07,540
show that you took the vaccine
and you have an adverse event
798
00:55:07,540 --> 00:55:10,240
that is on the list, you
automatically become eligible
799
00:55:10,240 --> 00:55:14,080
for the compensation. So there's
two different types of
800
00:55:14,080 --> 00:55:15,310
approaches for the same thing.
801
00:55:15,640 --> 00:55:18,220
Chris Patterson: Would that span
out, because I mean, we have had
802
00:55:18,250 --> 00:55:21,160
a New Zealand, and I'm not sure
about Australia, but there have
803
00:55:21,160 --> 00:55:25,510
been some limited examples where
the reaction has been fatal
804
00:55:25,510 --> 00:55:29,080
people have have actually died,
not large numbers that I'm aware
805
00:55:29,080 --> 00:55:33,400
of. But would that lead to an
Australia that the family
806
00:55:33,880 --> 00:55:37,180
bringing some form of
compensation claim for the
807
00:55:37,180 --> 00:55:37,630
estate?
808
00:55:38,860 --> 00:55:42,310
Marco Rizzi: Interesting, that's
an interesting one. So the
809
00:55:42,340 --> 00:55:46,660
injury claims is for the
patient, not for the not for the
810
00:55:46,660 --> 00:55:52,870
family. I think so the the cases
in which there has been a fatal
811
00:55:53,650 --> 00:56:00,430
adverse reaction. In Australia,
I believe, all involved, or
812
00:56:00,430 --> 00:56:03,040
almost all involved the
AstraZeneca vaccine, so it was
813
00:56:03,040 --> 00:56:08,590
from the thrombosis. Now, there
are other social security
814
00:56:08,620 --> 00:56:11,830
mechanisms that can assist
families in those situations,
815
00:56:12,190 --> 00:56:16,930
the compensation scheme itself
is actually targeted at
816
00:56:16,960 --> 00:56:21,850
individuals, not their families.
So it is, and that is a
817
00:56:21,850 --> 00:56:27,610
limitation in a way, of course,
but I think the point is,
818
00:56:27,610 --> 00:56:33,250
particularly, because the vast
majority of adverse events tend
819
00:56:33,250 --> 00:56:39,010
to be temporary, or, you know,
they can have, they can be more
820
00:56:39,010 --> 00:56:43,870
or less prolonged in time, but
what they all tend to resolve.
821
00:56:44,170 --> 00:56:50,260
So like the, you know, the heart
issues that can be linked to the
822
00:56:50,260 --> 00:56:53,860
Pfizer vaccine, for example,
when they're in a one, they all
823
00:56:53,860 --> 00:56:57,100
tend to resolve within a certain
period of time. However, during
824
00:56:57,100 --> 00:56:59,650
that period of time, you may
lose income, you may lose a
825
00:56:59,650 --> 00:57:02,320
manager, you may lose a whole
bunch of things. So that's what
826
00:57:02,350 --> 00:57:08,110
the compensation scheme tends to
focus on. So the fact that is
827
00:57:08,110 --> 00:57:10,690
literally providing a safety
net, when you're essentially
828
00:57:10,690 --> 00:57:13,480
disabled for a certain period of
time, if you're disabled
829
00:57:13,480 --> 00:57:16,360
permanently, there are also
other schemes that kick in, in
830
00:57:16,360 --> 00:57:19,360
Australia. So like, there's the
NDIS, the National Disability
831
00:57:19,540 --> 00:57:24,040
Insurance Scheme. And so that's
a different kind of, depending
832
00:57:24,040 --> 00:57:26,320
on the gravity, I think the
point of the no fault
833
00:57:26,320 --> 00:57:30,850
compensation scheme was really
providing a safety net for those
834
00:57:30,850 --> 00:57:37,180
who were experiencing serious
adverse event that had a serious
835
00:57:37,180 --> 00:57:39,490
impact for a discrete period of
time.
836
00:57:40,530 --> 00:57:43,290
Chris Patterson: So Marco,
before we move off the COVID
837
00:57:43,290 --> 00:57:46,020
vaccine, because I want to get
into the area of medical
838
00:57:46,020 --> 00:57:49,710
devices. And I want to pick your
brain on that one. But before we
839
00:57:49,710 --> 00:57:54,720
do just just couple of points.
One is we're able to now stand
840
00:57:54,720 --> 00:58:00,180
back, you know, where are we,
we're in October 2022, you know,
841
00:58:00,210 --> 00:58:05,760
20 months, from, I guess, the,
you know, 22 months and from the
842
00:58:05,760 --> 00:58:11,730
pandemic being announced
etcetera. What's your assessment
843
00:58:11,730 --> 00:58:16,410
on a scorecard, if we do a scale
of 1 to 10, in terms of the
844
00:58:16,410 --> 00:58:20,940
Australian regulatory response
to approving the various
845
00:58:20,940 --> 00:58:23,880
vaccines? I mean, did the
regular, and I know it was an
846
00:58:23,880 --> 00:58:28,980
emergency. And I know, it's
unprecedented. But did you know,
847
00:58:29,250 --> 00:58:30,240
did they perform?
848
00:58:30,000 --> 00:58:38,760
Marco Rizzi: I think the
regulatory regime in Australia,
849
00:58:38,760 --> 00:58:43,020
but I would say, around the
world, mostly performed
850
00:58:43,020 --> 00:58:46,590
remarkably well under the level
of pressure that it was
851
00:58:46,620 --> 00:58:51,870
operating. So it is easy today
to you know, cast, you know, an
852
00:58:51,870 --> 00:58:55,560
eye your eye back and be like,
ah, they were rushed here, or
853
00:58:55,560 --> 00:58:59,610
they didn't do well enough
there. But I think it's
854
00:58:59,610 --> 00:59:03,510
important to remember where we
were at in early 2020. And in
855
00:59:03,510 --> 00:59:07,980
mid 2020, and when the first
wave was really, really, really
856
00:59:08,280 --> 00:59:13,740
hitting Europe and the United
States incredibly hard. And the
857
00:59:13,740 --> 00:59:17,250
fact that, you know, we were
able to have a number of
858
00:59:17,250 --> 00:59:20,730
different vaccines within such a
short period of time is
859
00:59:20,730 --> 00:59:26,280
remarkable. And the fact that
none of them really carried
860
00:59:27,390 --> 00:59:36,210
risks of serious adverse events
above what was still, I think, a
861
00:59:36,240 --> 00:59:40,320
marginally small number of
circumstances that I'm talking
862
00:59:40,320 --> 00:59:42,780
about. And I have to say it's
important here to distinguish
863
00:59:42,780 --> 00:59:47,190
between people who are healthy
and versus people who have like
864
00:59:47,190 --> 00:59:51,690
pre existing such as like immune
conditions. Yeah. Because people
865
00:59:51,750 --> 00:59:53,790
with that sort of, for a lot of
people with underlying
866
00:59:53,790 --> 00:59:58,710
conditions. The pandemic is
actually a lot worse now almost
867
00:59:58,710 --> 01:00:02,370
than it was then, because they
can't have the vaccine. And so
868
01:00:02,370 --> 01:00:08,250
they are, I know, I'm, as you
know, I'm an academic, I have
869
01:00:08,250 --> 01:00:11,010
certain students who have been
essentially locked in their
870
01:00:11,010 --> 01:00:18,090
houses for well to two years now
over and they have no realistic
871
01:00:18,090 --> 01:00:20,910
prospect of ever coming out
because they know that if they
872
01:00:20,910 --> 01:00:24,300
get COVID, that can be fatal to
them, given their underlying
873
01:00:24,300 --> 01:00:27,960
condition. And their underlying
condition is also what prevents
874
01:00:27,960 --> 01:00:31,500
them from being vaccinated
because they have certain risks
875
01:00:31,530 --> 01:00:36,330
of adverse events, they're so
egregious that they actually
876
01:00:36,330 --> 01:00:41,190
can't do it. So I think it's
important not to, you know, fall
877
01:00:41,190 --> 01:00:44,670
into the trap of like, what you
would call an ableist narrative
878
01:00:44,700 --> 01:00:48,240
of the pandemic. But let's say
that by and large, I think the
879
01:00:48,240 --> 01:00:52,260
vaccines have been developed at
breakneck speed, and they are
880
01:00:52,290 --> 01:00:54,960
remarkably safe and effective.
And the fact that the
881
01:00:54,960 --> 01:00:59,670
AstraZeneca potential fatal side
effect was picked up so quickly
882
01:01:01,380 --> 01:01:06,870
was, you know, I think, a
testament to how well these the
883
01:01:06,870 --> 01:01:10,500
systems work. And I think, you
know, if you want to segue into
884
01:01:10,500 --> 01:01:15,480
medical devices, I think, if
there was ever like a, you know,
885
01:01:15,660 --> 01:01:20,160
if there was ever proof that we
do have systems that are not
886
01:01:20,160 --> 01:01:24,990
perfect, but by and large work,
the COVID vaccine was probably
887
01:01:25,020 --> 01:01:29,280
the biggest stress test that any
regulatory regime has ever, ever
888
01:01:29,310 --> 01:01:29,910
endured.
889
01:01:30,240 --> 01:01:33,510
Chris Patterson: Yeah, and look,
I guess the the point that I'm
890
01:01:33,630 --> 01:01:37,890
quite keen to get your view on,
is that it's all very well, the
891
01:01:37,890 --> 01:01:40,620
pharmaceuticals producing a
product like in this case a
892
01:01:40,620 --> 01:01:45,540
vaccine. But the regulations the
and the regulatory approval
893
01:01:45,540 --> 01:01:49,560
process, ordinarily, as you, as
you've told us, and rightly so
894
01:01:49,620 --> 01:01:53,820
can take years, but in this
case, it was done at an
895
01:01:53,820 --> 01:02:00,960
accelerated pace. And is it your
view, do you feel that looking
896
01:02:00,960 --> 01:02:04,200
back on it, because, you know,
hindsight is always 20/20, you
897
01:02:04,200 --> 01:02:08,370
know, we've got the benefit of
it, is that the Australian
898
01:02:08,370 --> 01:02:14,850
regulatory regime responded to
the the emergency that it was in
899
01:02:14,850 --> 01:02:20,040
an efficient way and certified
it and approved it, got it, and
900
01:02:20,040 --> 01:02:21,930
it was then available for
distribution.
901
01:02:22,800 --> 01:02:26,190
Marco Rizzi: Yeah. So just to
just to clarify a point that
902
01:02:26,190 --> 01:02:29,400
you've made. So my answer to
your question is yes, I think it
903
01:02:29,400 --> 01:02:36,330
did. In terms of like, why, how
on earth did these vaccines come
904
01:02:36,330 --> 01:02:41,160
to exist in such a short amount
of time when they normally takes
905
01:02:41,160 --> 01:02:45,030
so a new vaccine can take up to
15 years to be developed from
906
01:02:45,030 --> 01:02:49,650
development to rollout? So how
on earth did we do that in a
907
01:02:49,650 --> 01:02:53,970
year? I think there's a little
bit of myth, mythology around
908
01:02:53,970 --> 01:02:58,200
this that needs to be addressed.
The reality is that often it
909
01:02:58,200 --> 01:03:04,080
takes this long, because it can
be really hard to run clinical
910
01:03:04,080 --> 01:03:07,710
trials, it can be hard to find
volunteers, it can be hard to
911
01:03:07,710 --> 01:03:14,400
find funding. Okay. So in this
particular situation, we had an
912
01:03:14,400 --> 01:03:19,380
endless supply of volunteers,
and unlimited funding, everyone
913
01:03:19,380 --> 01:03:22,860
was pouring money into this
particular into this particular
914
01:03:22,860 --> 01:03:26,100
research. So when you have
unlimited funding and unlimited
915
01:03:26,100 --> 01:03:31,230
volunteers for clinical trials,
that dramatically decreases the
916
01:03:31,230 --> 01:03:34,560
amount of time that is
necessary. So and that has
917
01:03:34,560 --> 01:03:37,410
nothing to do with how thorough
the tests are, it's just that
918
01:03:37,410 --> 01:03:41,910
you're able to do them much
quicker, because the 15 years
919
01:03:41,910 --> 01:03:45,540
that it normally takes, it's not
like you use your productively
920
01:03:45,540 --> 01:03:48,930
using time for 15 years, there
are gaps of like two or three
921
01:03:48,930 --> 01:03:51,330
years in which nothing happens,
because you're just waiting.
922
01:03:51,660 --> 01:03:55,140
Whereas in this case, again,
this was not this didn't happen.
923
01:03:55,380 --> 01:03:58,560
The second thing is that there
are circumstances in which
924
01:03:58,830 --> 01:04:03,750
regulators can the what they say
is fast track, they can fast
925
01:04:03,750 --> 01:04:07,470
track the approval of a drug.
And that's, you know, a pandemic
926
01:04:07,470 --> 01:04:10,860
is the obvious case. So when
there is a disease that is
927
01:04:10,890 --> 01:04:16,230
threatening a large portion of
the population, fast tracking
928
01:04:16,230 --> 01:04:20,250
doesn't mean you just take a
gamble. fast tracking means that
929
01:04:20,250 --> 01:04:27,900
you look at you still need to
have like at the front end data
930
01:04:27,930 --> 01:04:32,850
that satisfies the regulator on
10s of 1000s of participants. So
931
01:04:32,850 --> 01:04:35,460
for example, I think the
AstraZeneca one before it was
932
01:04:35,460 --> 01:04:39,240
approved had was it had been
tested on 30 to 40,000 people
933
01:04:40,560 --> 01:04:46,500
and similar numbers, I think
work for the Pfizer and Moderna
934
01:04:46,500 --> 01:04:50,160
vaccine. Fast track simply means
that you actually make a
935
01:04:50,160 --> 01:04:54,210
preliminary assessment on the
basis of this initial data. You
936
01:04:54,210 --> 01:04:57,060
roll out the vaccine and there
are stringent conditions you
937
01:04:57,060 --> 01:04:59,580
know, you have to monitor and
then you have to keep doing
938
01:04:59,580 --> 01:05:03,420
clinical files as the vaccine is
rolled out and the TGA or so the
939
01:05:03,420 --> 01:05:07,230
regulator performs what you call
a rolling review. And that's
940
01:05:07,230 --> 01:05:12,270
what, for instance, allowed the
thrombosis side effects linked
941
01:05:12,270 --> 01:05:16,350
to the AstraZeneca vaccine to be
picked off so quickly and acted
942
01:05:16,350 --> 01:05:20,370
upon so quickly. So, yes, I
think I think the regulatory
943
01:05:20,370 --> 01:05:24,750
regimes in Australia but across
around the world, were, were
944
01:05:24,840 --> 01:05:27,810
remarkably well under the level
of pressure that they were
945
01:05:27,810 --> 01:05:29,610
operating during the pandemic.
946
01:05:30,350 --> 01:05:33,320
Chris Patterson: And I guess, in
a way that the lessons or the
947
01:05:33,320 --> 01:05:36,770
examples from that may serve as
well into the future, because of
948
01:05:36,770 --> 01:05:40,010
course, I mean, I don't know
what your view, I'm keen to hear
949
01:05:40,010 --> 01:05:43,340
what it is, but I don't think
this pandemics actually over. I
950
01:05:43,340 --> 01:05:47,390
mean, we're still seeing in New
Zealand daily cases into the
951
01:05:47,420 --> 01:05:55,160
1000s. And, of course, the virus
COVID-19 is, the variants are
952
01:05:55,160 --> 01:05:58,520
changing. So there are new
variants that are developing.
953
01:05:59,000 --> 01:06:02,480
And some of the signals coming
out of particularly Europe is
954
01:06:02,480 --> 01:06:06,680
that some of these variants are
particularly able to evade
955
01:06:07,040 --> 01:06:11,060
immune responses, and quite
possibly the vaccines that we've
956
01:06:11,060 --> 01:06:14,360
all had. So we may be looking at
heavy to go for completely new
957
01:06:14,360 --> 01:06:16,430
rounds of vaccination.
958
01:06:16,000 --> 01:06:20,290
Marco Rizzi: Yeah, I mean, well,
the vaccine I had two days ago
959
01:06:20,290 --> 01:06:24,790
was Bivalent, so it was the
original strand. And then
960
01:06:24,790 --> 01:06:29,770
there's some specific Omicron
protection but how effective
961
01:06:29,770 --> 01:06:34,510
that will be, I guess we'll see.
But number one, the pandemic is
962
01:06:34,510 --> 01:06:39,430
definitely not over. There's the
the waves keep going up and
963
01:06:39,430 --> 01:06:42,130
down, I think we're going
towards the normalization of
964
01:06:42,130 --> 01:06:51,070
these waves. And I think that it
is not entirely, it is actually
965
01:06:51,070 --> 01:06:54,550
quite possible that what we're
going to be looking at is a
966
01:06:54,550 --> 01:07:01,750
seasonal vaccine for COVID, much
like we have for the flu. And
967
01:07:01,750 --> 01:07:07,660
whether it's going to be yearly
or or, you know, biannual, I
968
01:07:07,660 --> 01:07:11,920
don't know, we'll that will
depend. But I obviously the
969
01:07:11,920 --> 01:07:15,220
virus we haven't we haven't
defeated the virus, the virus is
970
01:07:15,220 --> 01:07:19,360
now in the community globally.
And we're going to have to deal
971
01:07:19,360 --> 01:07:22,210
with that, which is quite
concerning, particularly for
972
01:07:22,210 --> 01:07:25,540
individuals who are
immunocompromised because it
973
01:07:25,540 --> 01:07:30,160
that means there is a long term
issue of how are we going to
974
01:07:30,160 --> 01:07:33,190
protect these people. But from a
regulatory perspective, I
975
01:07:33,190 --> 01:07:37,630
suspect what pretty much every
country has is a special regime
976
01:07:37,630 --> 01:07:41,260
for the flu vaccine. So the flu
vaccine, you don't need to
977
01:07:41,260 --> 01:07:44,560
undergo the same level of
testing that you would need for
978
01:07:44,560 --> 01:07:48,970
a new brand new vaccines, all
you do is essentially, you add
979
01:07:48,970 --> 01:07:52,360
new strains to existing ones.
And that is a very speedy
980
01:07:52,360 --> 01:07:55,720
process. And essentially, every
country in the world has a
981
01:07:55,720 --> 01:08:01,210
special has a special regulatory
pathway for those vaccines,
982
01:08:01,210 --> 01:08:04,450
because you need them on a
yearly basis. And I think it is
983
01:08:04,870 --> 01:08:07,990
quite conceivable that COVID
vaccines will end up having the
984
01:08:07,990 --> 01:08:12,100
same type of parallel kind of
regulatory regime whereby like
985
01:08:12,100 --> 01:08:15,550
if all you're doing is adding
new strands, adding new sorry,
986
01:08:15,550 --> 01:08:19,540
adding new new streams and
adding new variants to an
987
01:08:19,540 --> 01:08:23,980
existing vaccine, the regulatory
review will be essentially
988
01:08:23,980 --> 01:08:27,760
minimal. Because we already know
it's an exam. The point is, it's
989
01:08:27,760 --> 01:08:30,550
a technology that exists and it
is well established. We know it
990
01:08:30,550 --> 01:08:34,840
is safe and effective. All we do
is we just make it effective
991
01:08:34,840 --> 01:08:38,320
against the new a new version of
the same, the same disease.
992
01:08:39,080 --> 01:08:41,810
Chris Patterson: Fascinating.
And look just lastly, before we
993
01:08:42,290 --> 01:08:44,960
move off medicines, it did occur
to me before I was just thinking
994
01:08:44,960 --> 01:08:51,800
about and I've mentioned the FDA
and the FDA being sort of
995
01:08:51,800 --> 01:08:58,100
somewhat more risk averse. You
can buy over the counter and use
996
01:08:58,100 --> 01:09:01,070
in the United States, melatonin
but in New Zealand, it's a
997
01:09:01,070 --> 01:09:03,830
prescription drug. Now I don't
know what the position is with
998
01:09:03,830 --> 01:09:07,280
melatonin in Australia can you
can just buy that at the
999
01:09:07,280 --> 01:09:11,240
Chemists Warehouse without a
prescription? Or is that is that
1000
01:09:11,240 --> 01:09:13,760
just still regarded as being a
bit too risky?
1001
01:09:15,390 --> 01:09:19,950
Marco Rizzi: So melatonin is I
think in Australia now Australia
1002
01:09:19,950 --> 01:09:26,490
is like New Zealand it is. So
Australia generally is quite
1003
01:09:26,760 --> 01:09:32,730
strict when it comes to
medicines. So even things like
1004
01:09:32,760 --> 01:09:39,000
topical steroid creams are very
tend to be prescription only.
1005
01:09:40,350 --> 01:09:46,020
And so melatonin I'm fairly sure
that the regime is the same as
1006
01:09:46,020 --> 01:09:47,790
in New Zealand so it's
prescription only.
1007
01:09:47,000 --> 01:09:51,860
Chris Patterson: I guess sort of
maybe the you know, America, my
1008
01:09:51,860 --> 01:09:55,130
perception is as they are
becoming more liberal around
1009
01:09:55,160 --> 01:09:59,600
therapeutics, I mean a good
example probably is their
1010
01:10:00,170 --> 01:10:04,220
cannabis industry, both in
America and in Canada are a
1011
01:10:04,220 --> 01:10:08,840
multi billion dollar industry
producing products, some of
1012
01:10:08,840 --> 01:10:13,910
which I guess you would call as
being therapeutic. Whereas, both
1013
01:10:13,940 --> 01:10:16,520
in New Zealand and Australia,
it's only been in recent times
1014
01:10:16,520 --> 01:10:20,630
that doctors could prescribe
municipal cannabis products. All
1015
01:10:20,630 --> 01:10:24,230
of those struggling with opioid
you know that you can't take
1016
01:10:24,230 --> 01:10:24,860
opioids.
1017
01:10:24,899 --> 01:10:27,749
Marco Rizzi: Well cannot
cannabis is the therapeutic use
1018
01:10:27,749 --> 01:10:33,209
of cannabis is, you know, as the
very kind of specific field and
1019
01:10:33,239 --> 01:10:36,539
there is actually abundant
evidence, like overwhelming
1020
01:10:36,539 --> 01:10:41,099
evidence that in certain
clinical circumstances, cannabis
1021
01:10:41,099 --> 01:10:46,829
has a significant, significantly
positive therapeutic impact on
1022
01:10:46,829 --> 01:10:49,859
patients. But I think generally,
you're correct in saying that,
1023
01:10:50,219 --> 01:10:56,399
the FDA tends to have a more
liberal approach a more, it's
1024
01:10:56,399 --> 01:11:02,819
almost like, because it is, I
mean, my take on this, having
1025
01:11:03,329 --> 01:11:06,389
looked at this, these these
issues for a number of years
1026
01:11:06,389 --> 01:11:11,369
now, is that once again, if you
look at the regulatory regime,
1027
01:11:13,109 --> 01:11:19,139
in separate segments, the FDA
and the American regime tends to
1028
01:11:19,139 --> 01:11:24,659
be more permissive. So there is
indeed a greater propensity to
1029
01:11:24,659 --> 01:11:29,129
risk, okay, so you know, we're
keen that people should have
1030
01:11:29,189 --> 01:11:33,089
products available, the
threshold is lower that you need
1031
01:11:33,089 --> 01:11:35,759
to meet in order. On the other
hand, if you look at it
1032
01:11:35,759 --> 01:11:37,979
holistically, there's the fact
that there's so much more
1033
01:11:37,979 --> 01:11:40,709
litigation occurring in American
litigation is so much more
1034
01:11:40,709 --> 01:11:45,389
accessible. Particularly not not
generally speaking, but
1035
01:11:45,389 --> 01:11:48,029
particularly when it comes to
these particular goods, given
1036
01:11:48,029 --> 01:11:52,439
the kind of the way in which it
is structured, that you have to
1037
01:11:52,439 --> 01:11:56,849
factor that in. So overall, the
the American approach is one
1038
01:11:56,849 --> 01:11:59,999
that looks at, you know, give
more opportunities at the front
1039
01:11:59,999 --> 01:12:03,359
end, and also provide
potentially more remedies or
1040
01:12:03,359 --> 01:12:06,689
more opportunities for causes of
action at the back end. Whereas
1041
01:12:06,689 --> 01:12:09,599
the European one traditionally
is a lot more like less prevent
1042
01:12:09,779 --> 01:12:12,299
the spirit to prevent accidents
from happening in the first
1043
01:12:12,299 --> 01:12:19,559
place. And then, you know, the
opportunities to litigate are
1044
01:12:19,559 --> 01:12:24,599
not as diffuse and not as
available as in America.
1045
01:12:24,840 --> 01:12:25,950
Chris Patterson: Okay, Marco.
Well, that's probably a good
1046
01:12:25,980 --> 01:12:28,740
segue into because I did want to
talk about medical devices
1047
01:12:28,740 --> 01:12:33,270
before we wrap up, and the one
was the pelvic mesh litigation.
1048
01:12:34,710 --> 01:12:38,880
That seems to be picking up on
your point, that exact point,
1049
01:12:39,330 --> 01:12:41,370
you know, when something goes
horribly wrong, I mean, what can
1050
01:12:41,370 --> 01:12:44,010
you tell us about the pelvic
mesh litigation?
1051
01:12:44,000 --> 01:12:46,340
Marco Rizzi: Yeah, so I think I
think the importance so there's
1052
01:12:46,340 --> 01:12:49,940
a premise to make here. So in
Australia, pelvic mesh is a is
1053
01:12:49,940 --> 01:12:53,660
a, so a pelvic mesh is an
implantable device. So it is an
1054
01:12:53,660 --> 01:12:59,030
implantable device, typically
implanted on women, or
1055
01:12:59,390 --> 01:13:03,830
conditions... So the ones that
were that formed the object of
1056
01:13:03,830 --> 01:13:09,050
litigation in Australia were
measures that were used for
1057
01:13:09,050 --> 01:13:13,370
pelvic organ prolapse, or stress
urinary incontinence. So these
1058
01:13:13,370 --> 01:13:18,500
are mildly, essentially minor
conditions, they're more, they
1059
01:13:18,500 --> 01:13:22,400
tend to be more of a, they can
be, they can be serious, but by
1060
01:13:22,400 --> 01:13:25,400
and large, they tend to be more
like a discomfort or like they
1061
01:13:25,400 --> 01:13:30,440
affect quality of life more than
anything else. And the pelvic
1062
01:13:30,440 --> 01:13:35,540
mesh is essentially it's, it's a
mesh that you implant, and that
1063
01:13:35,840 --> 01:13:39,920
keeps everything together,
essentially, and therefore
1064
01:13:39,950 --> 01:13:44,180
prevents the prolapse or
prevents the incontinence. Now
1065
01:13:44,180 --> 01:13:47,900
that what happened in Australia,
and actually across the globe,
1066
01:13:47,900 --> 01:13:51,560
really, is that it turned out
that these a lot of these
1067
01:13:51,950 --> 01:13:55,610
meshes, particularly the ones
that were imported by Johnson
1068
01:13:55,610 --> 01:14:00,140
and Johnson into Australia or by
and produced by imported and
1069
01:14:00,140 --> 01:14:06,410
produced in Australia by a firm
called Ethicon. The problem was
1070
01:14:06,410 --> 01:14:09,890
that they carry the significant
increased risk of chronic pain.
1071
01:14:10,370 --> 01:14:14,720
And, and, and what happened is
that 1000s, literally 1000s of
1072
01:14:14,720 --> 01:14:20,900
women who had these, who had
these meshes implanted for minor
1073
01:14:20,900 --> 01:14:24,050
conditions ended up having their
lives ruined, essentially,
1074
01:14:24,440 --> 01:14:28,850
because, number one, they were
not aware of the risks, the
1075
01:14:28,850 --> 01:14:32,780
risks were not acceptable, there
would not have, they were not
1076
01:14:32,780 --> 01:14:37,190
risks that for a product of that
kind, the general public would
1077
01:14:37,190 --> 01:14:42,800
have accepted as you know,
reasonable. And third, the issue
1078
01:14:42,800 --> 01:14:48,020
is there is no real remedy in in
therapeutically speaking because
1079
01:14:48,020 --> 01:14:50,540
in the vast majority of cases
you can't remove it so it's just
1080
01:14:50,540 --> 01:14:55,940
going to be there forever. What
happened there? What happened is
1081
01:14:55,940 --> 01:15:00,920
that we in for medicines, we've
talked about the fact that
1082
01:15:00,920 --> 01:15:05,480
there's this really, really well
developed regulatory regime that
1083
01:15:05,480 --> 01:15:09,710
with very thorough pre marketing
testing, that really comes from
1084
01:15:09,710 --> 01:15:12,590
the early 20th century in the
United States and the mid 20th
1085
01:15:12,590 --> 01:15:16,730
century in Europe on the back of
drug disasters. The problem with
1086
01:15:16,730 --> 01:15:19,280
medical devices is that for a
number of reasons that
1087
01:15:19,280 --> 01:15:21,800
historically they have the they
haven't developed this
1088
01:15:21,830 --> 01:15:25,400
therapeutic goods worthy of a
separate category of regulatory
1089
01:15:25,400 --> 01:15:29,810
attention. But they have by and
large, been packaged into just
1090
01:15:29,810 --> 01:15:34,130
consumer goods. And the fact is
that medical devices, when we
1091
01:15:34,130 --> 01:15:36,740
think of medical devices, we
normally you know, you can think
1092
01:15:36,740 --> 01:15:40,220
of stuff that is really fancy,
like I don't know, pacemakers,
1093
01:15:40,220 --> 01:15:46,880
or other such things. But
medical devices are a huge
1094
01:15:46,910 --> 01:15:51,440
category that includes anything
from band aids, condoms,
1095
01:15:53,060 --> 01:15:56,480
prosthetics, implants, so
everything is a medical,
1096
01:15:56,810 --> 01:16:02,330
anything that you use for
therapeutic diagnostics,
1097
01:16:02,330 --> 01:16:07,070
treatment monitoring, is can be
qualified as a medical device,
1098
01:16:07,070 --> 01:16:09,320
and they're regulated in
different classes. So every
1099
01:16:09,320 --> 01:16:12,170
class has a different type of
potential. Now, the problem is
1100
01:16:12,170 --> 01:16:16,340
that, as I said, about
medicines, what's that when I
1101
01:16:16,340 --> 01:16:19,820
said, I'm on medicines is true
about devices, Australia, mostly
1102
01:16:19,820 --> 01:16:24,440
imported devices. And a lot of
the devices imported came come
1103
01:16:24,440 --> 01:16:29,000
from the European Union, and the
European Union has had a huge
1104
01:16:29,330 --> 01:16:32,930
fail failure or regulatory
failure when it comes to medical
1105
01:16:32,930 --> 01:16:39,350
devices, because essentially,
what it did is that it did not
1106
01:16:39,350 --> 01:16:43,790
create a regulatory regime like
for medicines, but it put the
1107
01:16:43,790 --> 01:16:48,170
regulation of goods of medical
devices into the bigger bag of
1108
01:16:48,230 --> 01:16:52,820
regulation of goods, consumer
goods. So the way it happens is,
1109
01:16:53,480 --> 01:16:59,450
you have a broad legislation
that gives goals, general goals.
1110
01:16:59,990 --> 01:17:03,350
And then you have what are
called notified bodies, these
1111
01:17:03,350 --> 01:17:08,810
are typically private companies
that issue quality assurance
1112
01:17:08,840 --> 01:17:13,310
certificates. So a manufacturer
will go to a notified body and
1113
01:17:13,310 --> 01:17:17,390
say, like, Hey, I have this new
product, and you just, you know,
1114
01:17:17,420 --> 01:17:21,050
test it against certain
standards. And then if you're
1115
01:17:21,050 --> 01:17:24,800
satisfied that you know it, it
meets the standards give us the
1116
01:17:24,800 --> 01:17:30,140
quality assurance certificate.
And the problem is, if you if
1117
01:17:30,140 --> 01:17:33,530
you kind of outsource that to an
industry and their core business
1118
01:17:33,560 --> 01:17:37,280
is performing quality assurance,
the risk of moral hazard is
1119
01:17:37,280 --> 01:17:40,160
huge. And just to give an
example, that is relevant to
1120
01:17:40,160 --> 01:17:46,130
mesh, in 2018, there was this
huge scandal called the Implant
1121
01:17:46,130 --> 01:17:48,230
Files. So there's a group of
journalists called the
1122
01:17:48,230 --> 01:17:51,800
International Consortium of
Investigative Journalists, the
1123
01:17:51,800 --> 01:17:56,510
ones who uncovered the Panama
Papers. So they call it they had
1124
01:17:56,510 --> 01:17:59,660
this huge investigation called
the Implant Files. And there was
1125
01:17:59,660 --> 01:18:04,610
this one Dutch journalist that
did this incredible thing. So
1126
01:18:04,610 --> 01:18:09,860
she she bought a mandarin net
from the supermarket. She cut it
1127
01:18:09,860 --> 01:18:13,040
out in a way that was fancy
looking. And it was literally
1128
01:18:13,070 --> 01:18:15,950
like the, you know, the red
mandarin nets that...
1129
01:18:15,950 --> 01:18:19,160
Chris Patterson: Yeah, you go to
the grocery store, you go into
1130
01:18:19,160 --> 01:18:22,010
the fruit section and there's
the mandarins, they're in a net.
1131
01:18:22,000 --> 01:18:24,790
Marco Rizzi: Yeah, exactly. So
she took the mandarins out, she
1132
01:18:24,790 --> 01:18:29,560
cut the mesh the net in a way
that looked fancy. And then she
1133
01:18:29,560 --> 01:18:32,710
produced the bogus technical
file. And she introduced herself
1134
01:18:32,710 --> 01:18:35,590
with a few colleagues who are
not one of these notified bodies
1135
01:18:35,590 --> 01:18:40,090
to ask what you know, we have
developed this cool new mesh,
1136
01:18:40,510 --> 01:18:44,170
would we get approved? And
there's and the reality is that
1137
01:18:44,170 --> 01:18:49,120
they had they received the
preliminary approval from a
1138
01:18:49,120 --> 01:18:52,270
notified body on the basis of
the fact that oh, yeah, many
1139
01:18:52,270 --> 01:18:54,940
similar products already exist
on the market, and therefore I
1140
01:18:54,940 --> 01:18:57,730
don't see this as an issue. Now,
that was obviously they didn't
1141
01:18:57,730 --> 01:19:02,080
market the net, but they did
that to show how lax the
1142
01:19:02,080 --> 01:19:07,960
regulatory system was, and these
meshes that were distributed in
1143
01:19:07,960 --> 01:19:15,010
Australia, all came from this
European, very weak system,
1144
01:19:15,040 --> 01:19:18,220
regulatory system. So I think
what I'm trying to say is that
1145
01:19:18,220 --> 01:19:21,730
the problem with medical devices
is that they do they are they
1146
01:19:21,730 --> 01:19:27,940
can be as invasive and they can
have as dramatic an impact on
1147
01:19:27,940 --> 01:19:32,380
the life of patients as
medicines do. But for historical
1148
01:19:32,380 --> 01:19:36,520
reasons, they have escaped the
level of scrutiny that medicines
1149
01:19:36,520 --> 01:19:40,240
have on the other hand, gained
very early on in the piece and
1150
01:19:40,240 --> 01:19:43,900
it is only now I think that we
are moving towards a much more
1151
01:19:43,900 --> 01:19:49,330
thorough and a much more close
attention to pre marketing pre
1152
01:19:49,330 --> 01:19:52,210
distribution requirements for
devices.
1153
01:19:53,219 --> 01:19:55,568
Chris Patterson: Yeah. Hey
Marco. I wanted to thank you,
1154
01:19:55,628 --> 01:19:59,363
grazie, for joining me on the
Law Down Under Podcast and look,
1155
01:19:59,423 --> 01:20:02,917
this has been a fascinating,
deep dive into health law but
1156
01:20:02,977 --> 01:20:06,531
also, you know, therapeutic
goods. You've given us a lot of
1157
01:20:06,592 --> 01:20:10,507
insights, there's a lot there to
take in. I really appreciate it.
1158
01:20:10,567 --> 01:20:14,242
And look, I hope that we can, we
can keep in contact, because
1159
01:20:14,302 --> 01:20:17,977
that's that there's some topics
here that I'd actually really
1160
01:20:18,037 --> 01:20:21,832
like to get into in more detail
with you're at a later time. So
1161
01:20:21,893 --> 01:20:23,399
thank you for joining me.
1162
01:20:23,399 --> 01:20:26,492
Marco Rizzi: Oh, absolutely. If
you want to chat about devices
1163
01:20:26,555 --> 01:20:29,460
more in more detail ever, any
time. Thank you.
1164
01:20:29,460 --> 01:20:31,625
Chris Patterson: Absolutely. And
it's been really good. So look,
1165
01:20:31,671 --> 01:20:34,850
enjoy the rest of your day. And
thanks for joining me on the podcast.
1166
01:20:35,130 --> 01:20:36,330
Marco Rizzi: Thank you again for
having me.
1167
01:20:37,970 --> 01:20:40,780
Chris Patterson: Thank you for
tuning in and listening to this
1168
01:20:40,843 --> 01:20:44,653
episode of the Law Down Under
Podcast. You're welcome to join
1169
01:20:44,716 --> 01:20:48,151
in on the discussion via my
podcast page, which you can
1170
01:20:48,214 --> 01:20:51,961
access at patterson.co.nz That's
patterson.co.nz. Thanks for
1171
01:20:52,024 --> 01:20:55,834
supporting the podcast and tune
in again for more on the law,
1172
01:20:55,897 --> 01:20:59,520
its application and the future
of the law here down under.