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Expert
Conference
on
the
Revision
of
the
Declara5on
of
Helsinki
March
1st,
2013
Tokyo,
Japan
2
• Introduc5on
• General
Posi5on
Statements
on
the
Revision
of
the
Declara5on
of
Helsinki
• Posi5on
Statements
on
Post-‐study
Access
– Comments
on
Sponsor’s
Role
and
Responsibili3es
in
Post-‐Study
Access
Outline
3
Introduc5on
• Biopharmaceu5cal
companies
are
commiLed
to
high-‐quality
clinical
research
that
is
both
scien5fically
and
ethically
rigorous
• Biopharmaceu5cal
companies
are
commiLed
to
sponsoring
clinical
trials
that
fully
comply
with
all
legal
and
regulatory
requirements
• PhRMA
highly
values
the
fundamental
principles
of
the
Declara5on
of
Helsinki
and
has
incorporated
them
into
its
own
voluntary
principles
• Principles
on
Conduct
of
Clinical
Trials
and
Communica3on
of
Clinical
Trials
Results
(PhRMA,
2009)
“In
sponsoring
and
conduc9ng
clinical
research,
PhRMA
members
place
great
importance
on
respec9ng
and
protec9ng
the
safety
of
research
par9cipants.
Principles
for
the
conduct
of
clinical
research
are
set
forth
in
interna9onally
recognized
documents,
such
as
the
Declara9on
of
Helsinki
and
the
Guideline
for
Good
Clinical
Prac9ce
of
the
Interna9onal
Conference
on
Harmoniza9on.”
General
Posi5on
Statements
on
the
Revision
of
the
Declara5on
of
Helsinki
• PhRMA
recognizes
the
importance
of
preserving
the
original
intent
of
the
Declara3on
of
Helsinki
as
a
concise
set
of
guiding
principles
addressing
ethical
responsibili3es
of
physicians
and
physician-‐inves3gators
• Biopharmaceu3cal
companies
remain
suppor3ve
of
the
basic
principles
of
the
Declara3on
of
Helsinki
and
other
global
ethical
guidance
documents,
in
alignment
with
their
obliga3on
to
comply
with
the
legal
and
regulatory
requirements
of
clinical
trials
• PhRMA
welcomes
the
opportunity
to
contribute
expert
input
and
support
the
WMA
with
any
future
revision
of
the
Declara3on
of
Helsinki
4
• PhRMA
recognizes
the
value
of
providing
addi5onal
clarity
on
post-‐
study
access
in
the
Declara5on
of
Helsinki,
without
altering
its
original
intent
of
a
set
of
guiding
principles:
– Clearly
define
what
cons3tutes
post-‐study
access
– Make
explicit
reference
to
roles
and
responsibili3es
in
providing
post-‐
study
access,
including
:
– Primary
responsibility
of
host-‐country
governments
to
provide
access
to
medical
care
(including
approved
medicines)
through
their
healthcare
systems
– Role
and
responsibility
of
local
Na3onal
Regulatory
Authori3es
(NRAs)
and
Ethic
Review
CommiSees
(ERCs)
in
determining
whether
a
proposed
research
study
is
suitable
for
the
host-‐country
– Strengthen
the
concept
that
post-‐study
benefits
to
study
par3cipants
and
host
communi3es
can
take
many
forms,
and
are
not
limited
to
the
poten3al
iden3fica3on
of
a
beneficial
interven3on
in
the
study
5
Posi5on
Statements
on
Post-‐study
Access
Comments
on
Sponsor’s
Role
and
Responsibili5es
in
Post-‐Study
Access
• Comments
are
specific
for
post-‐study
access
to
study
medica5ons
by
pa5ents
who
par5cipated
in
a
clinical
trial
• The
sponsor
may
offer
post-‐study
access
to
study
medica5ons
in
specific
circumstances
(for
example,
life-‐threatening
diseases,
severe
debilita6ng
medical
condi6ons,
or
clinical
emergencies
for
which
no
appropriate
alterna6ve
therapies
are
locally
available):
– Subject
to
local
legal
and
regulatory
requirements
– Guided
by
the
best
available
evidence
for
a
favorable
benefit/risk
profile
• Plans
for
post-‐study
access
(including
discon5nua5on)
should
be
guided
by
the
documented
pre-‐trial
agreement
and
any
poten5al
modifica5ons
• In
cases
where
the
sponsor
plans
to
provide
post-‐study
access
to
the
study
medica5on,
supply
may
be
discon5nued
if:
– In
the
sponsor’s
opinion,
new
informa3on
becomes
available
that
affects
nega3vely
the
previous
benefit/risk
assessment
of
the
medica3on
– The
reviewing
agency
rejects
the
request
for
marke3ng
authoriza3on
based
upon
an
assessment
of
benefit/risk
and
there
are
no
further
plans
to
seek
authoriza3on
• In
all
circumstances,
the
sponsor
will
work
with
relevant
local
healthcare
authori5es
and
services
in
the
best
interest
of
the
study
par5cipants
6