Q. How long does it
take new biotech
medicines to reach
patients?
A. It
depends on where to live in Europe as some Member
States are delaying patient access to biotech medicines.
All
biotech medicines must
go through the EMEA (European
Medicines Agency) for
marketing authorisation.
These medicines are
among the most
innovative treatments in
the world and are
treating common diseases
like cancer and heart
disease but also
generating a whole new
range of targeted
therapies for rare
disorders like cystic
fibrosis.
According to the EFPIA
Patient W.A.I.T.
indicator, many new
medicines do not even
reach the patient.
There are only two EU
countries (Germany and
the UK) where patients
can expect to benefit
from all EMEA approved
new medicines.
Below
you can see the average
time delay between
marketing authorisation
and market access for
EMEA medicines with
marketing authorisation.
Number of new medicines
available to patients at
reference date
All new medicines with
marketing authorisation
from 1 January 2003 to
31 December 2006
Situation as at 30th
June 2007
|
Country |
Number with MA |
Number
accessible to
patients |
Number with
decision pending |
Number with
reimburse-ment
denied |
Number
inaccessible to
patients |
|
Austria
|
83
|
46
|
9
|
|
12
|
|
Belgium
|
84
|
48
|
10
|
6
|
20
|
|
Czech Rep.
|
67
|
48
|
10
|
1
|
8
|
|
Denmark
|
81
|
25
|
40
|
|
5
|
|
Estonia
|
63
|
11
|
26
|
17
|
9
|
|
Finland
|
86
|
56
|
5
|
10
|
15
|
|
France
|
84
|
47
|
17
|
10
|
10
|
|
Germany
|
80
|
80
|
0
|
0
|
0
|
|
Greece
|
83
|
56
|
24
|
2
|
1
|
|
Hungary
|
85
|
34
|
21
|
9
|
21
|
|
Ireland
|
72
|
57
|
11
|
0
|
4
|
|
Italy
|
73
|
48
|
12
|
8
|
5
|
|
Netherlands
|
78
|
59
|
11
|
3
|
5
|
|
Norway
|
85
|
37
|
11
|
|
13
|
|
Poland
|
78
|
|
|
|
32
|
|
Portugal
|
87
|
30
|
21
|
10
|
26
|
|
Slovakia
|
72
|
48
|
18
|
1
|
5
|
|
Slovenia
|
63
|
28
|
24
|
5
|
6
|
|
Spain
|
82
|
44
|
19
|
2
|
17
|
|
Sweden
|
85
|
57
|
0
|
|
10
|
|
Switzerland
|
79
|
51
|
20
|
4
|
4
|
|
UK
|
77
|
77
|
0
|
0
|
0
|
|
US
|
69
|
69
|
0
|
0
|
0
|
Table: EFPIA
Patient W.A.I.T. indicator
*For Norway,
molecules
with no
reimbursement
includes
products
reimbursed
for
individual
patients
** For
Poland, 5
molecules
are covered
either
through open
care,
hospital or
through
oncology
catalogues.
Non
reimbursed
products
include
molecules
covered by
drug
programmes
(limited
number of
patients/indications).
***For
Sweden,
molecules
with no
reimbursement
includes
products
with no
pricing
needed
Reasons behind these
delays vary from Member
State to Member State,
but at EuropaBio we feel
that patients would get
greater access to
biotech treatments if
there was more value
placed on healthcare
innovations when health
technologies are being
assessed in national
medicines agencies.
To learn more about
health technology
assessments and our
campaign to get the true
value of these
treatments acknowledged,
see our
Value of Innovation page.
To learn more about the
Patient W.A.I.T.
Indicator