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Rare diseases and orphan drugs: Latvian story.
[phenylketonuria]
BackgroundTen
years
have
passed
since
Latvia
became
a
Member
State
of
the
EU
in
2004
.
As
a
result
European
regulations
,
including
those
related
to
rare
diseases
and
orphan
drugs
,
have
been
applied
to
Latvian
legislative
system
.
Orphan
diseases
have
been
recognized
as
a
priority
area
for
action
in
the
public
health
system
,
though
there
are
significant
differences
in
the
national
healthcare
services
for
rare
diseases
among
the
EU
States
.
This
study
aims
to
determine
situation
in
the
field
of
rare
diseases
in
Latvia
and
compare
it
with
other
European
countries
.
M
ethodsWe
used
the
national
plan
for
rare
diseases
,
EUCERD
reports
,
Orphanet
data
,
Latvian
and
European
regulations
,
publicly
available
data
from
the
state
agencies
,
and
directly
contacted
drug
manufacturers
and
wholesalers
.
ResultsNational
plan
for
rare
diseases
was
developed
and
approved
in
2013
.
Although
there
are
no
official
designated
centers
of
expertise
as
well
as
no
specific
register
for
rare
diseases
.
Newborns
are
screened
for
only
two
disorders
:
phenylketonuria
and
congenital
hypothyroidism
.
Currently
34
orphan
drugs
are
available
on
Latvian
market
.
Three
medicines
(
8
.
8
%
)
are
included
in
the
reimbursement
drug
list
,
all
indicated
for
Ph
¿
+
¿
CML
.
15
drugs
(
44
.
1
%
)
were
reimbursed
within
the
framework
of
individual
reimbursement
system
,
and
five
drugs
(
14
.
7
%
)
were
provided
within
the
program
of
medicinal
treatment
of
rare
diseases
in
children
.
ConclusionsMajority
of
orphan
drugs
authorized
in
the
EU
are
not
available
in
Latvia
,
moreover
those
drugs
that
are
available
are
often
not
accessible
because
they
are
insufficiently
reimbursed
.
Besides
,
approval
of
the
national
plan
might
be
an
important
step
towards
improving
situation
in
the
field
of
rare
diseases
.
Diseases
Validation
Diseases presenting
"publicly available data from the state agencies"
symptom
phenylketonuria
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