Value of Innovation

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

16*

12
Belgium
84
48
10
6
20
Czech Rep.
67
48
10
1
8
Denmark
81
25
40

11**

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

24*

13
Poland
78

5**

30**

11**

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

18***

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

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