Background
Methods
Study design and data sources
Statistical analysis
Results
Period 1995-1999 | Period 2000-2004 | Period 2005-2009 | ||||
---|---|---|---|---|---|---|
Characteristics | Num. of authorizations (%) | Num. of NCEs (%) | Num. of authorizations (%) | Num. of NCEs (%) | Num. of authorizations (%) | Num. of NCEs (%) |
Total | 86 (100) | 70 (100) | 143 (100) | 116 (100) | 291 (100) | 152 (100) |
Type of intervention
| ||||||
Prevention | 15 (17.4) | 12 (17.1) | 13 (9.1) | 7 (6.0) | 56 (19.2) | 19 (12.5) |
Diagnosis | 4 (4.6) | 3 (4.3) | 4 (2.8) | 4 (3.4) | 5 (1.7) | 5 (3.3) |
Treatment | 65 (75.6) | 53 (75.7) | 122 (85.3) | 101 (87.1) | 214 (73.5) | 120 (78.9) |
Palliative care/rehabilitation | 2 (2.3) | 2 (2.9) | 4 (2.8) | 4 (3.4) | 16 (5.5) | 8 (5.3) |
Disease seriousness
| ||||||
Serious disease | 59 (68.6) | 50 (71.4) | 104 (72.7) | 86 (74.1) | 191 (65.6) | 109 (71.7) |
Nonserious disease | 11 (12.8) | 9 (12.9) | 21 (14.7) | 17 (14.6) | 44 (15.1) | 20 (13.2) |
Risk factor for serious disease | 16 (18.6) | 11 (15.7) | 18 (12.6) | 13 (11.2) | 56 (19.2) | 23 (15.1) |
New mechanism of action
|
18 (20.9)
|
17 (24.3)
|
44 (30.8)
|
42 (36.2)
|
32 (11.0)
|
27 (17.8)
|
Fixed-dose combinations
|
6 (7.0)
|
4 (5.7)
|
13 (9.1)
|
8 (6.9)
|
37 (12.7)
|
18 (11.8)
|
Biotechnological/biological product
|
27 (31.4)
|
24 (34.3)
|
52 (36.4)
|
41 (35.3)
|
77 (26.5)
|
42 (27.6)
|
Orphan medicinal product*
| - | - |
18 (12.6)
|
18 (15.5)
|
39 (13.4)
|
39 (25.7)
|
Generic and/or "biosimilar"*
| - | - | - | - |
69 (23.7)
| - |
Disease conditions | Medicinal products for human use, 1995-2009 | Burden of disease in the population | ||||
---|---|---|---|---|---|---|
Marketing authorizations | NCEs | Mortality per 106(%) | DALYs per 106(%) | |||
Number (%) | Number (%) | Worldwide | EU-25 | Worldwide | EU-25 | |
Communicable diseases
|
100 (19.2)
|
75 (22.2)
|
18.0 (30.6)
|
0.2 (4.8)
|
604.0 (39.7)
|
2.7 (4.6)
|
Infectious and parasitic diseases | 68 (13.1) | 56 (16.6) | 9.5 (16.2) | .06 (1.3) | 302.1 (19.8) | 0.9 (1.6) |
Respiratory infections | 19 (3.6) | 8 (2.4) | 4.3 (7.2) | 0.1 (3.1) | 97.8 (6.4) | 0.6 (1.0) |
Maternal conditions | 11 (2.1) | 9 (2.7) | 0.5 (0.9) | .00 (0.0) | 38.9 (2.6) | 0.2 (0.3) |
Perinatal conditions | 2 (0.4) | 2 (0.6) | 3.2 (5.4) | .01 (0.3) | 126.4 (8.3) | 0.6 (1.0) |
Noncommunicable diseases
|
419 (80.6)
|
262 (77.5)
|
35.0 (59.6)
|
4.0 (89.9)
|
731.6 (48.0)
|
51.1 (87.4)
|
Malignant neoplasms | 73 (14.0) | 59 (17.5) | 7.4 (12.6) | 1.2 (27.0) | 77.8 (5.1) | 9.7 (16.6) |
Other neoplasms | 1 (0.2) | 1 (0.3) | 0.2 (0.3) | .03 (0.8) | 1.9 (0.1) | 0.2 (0.3) |
Diabetes mellitus | 46 (8.8) | 25 (7.4) | 1.1 (1.9) | 0.1 (2.3) | 19.7 (1.3) | 1.5 (2.5) |
Blood and endocrine disorders | 59 (11.3) | 43 (12.7) | 0.3 (0.5) | .03 (0.7) | 10.4 (0.7) | 0.7 (1.3) |
Neuropsychiatric conditions | 66 (12.7) | 37 (10.9) | 1.3 (2.1) | 0.2 (4.8) | 199.3 (13.1) | 14.3 (24.5) |
Sense organ diseases | 11 (2.1) | 10 (3.0) | 0.0 (0.0) | 0.0 (0.0) | 86.9 (5.7) | 4.4 (7.5) |
Cardiovascular diseases | 75 (14.4) | 29 (8.6) | 17.1 (29.0) | 1.8 (42.0) | 151.4 (9.9) | 10.2 (17.4) |
Respiratory diseases | 11 (2.1) | 6 (1.8) | 4.0 (6.9) | 0.2 (4.9) | 59.0 (3.9) | 3.1 (5.4) |
Digestive diseases | 10 (1.9) | 4 (1.2) | 2.0 (3.5) | 0.2 (4.8) | 42.5 (2.8) | 2.7 (4.6) |
Genitourinary diseases | 23 (4.4) | 13 (3.8) | 0.9 (1.6) | .07 (1.6) | 14.7 (1.0) | 0.5 (0.8) |
Skin diseases | 7 (1.3) | 7 (2.1) | .07 (0.1) | 0.0 (0.2) | 4.0 (0.3) | 0.1 (0.2) |
Musculoskeletal diseases | 31 (6.0) | 24 (7.1) | 0.1 (0.2) | .02 (0.5) | 30.9 (2.0) | 2.6 (4.4) |
Congenital anomalies | 5 (1.0) | 3 (0.9) | 0.4 (0.7) | .01 (0.3) | 25.3 (1.7) | 0.6 (1.0) |
Oral conditions | 1 (0.2) | 1 (0.3) | 0.0 (0.0) | 0.0 (0.0) | 7.9 (0.5) | 0.4 (0.7) |
Unintentional injuries (poisoning) |
1 (0.2)
|
1 (0.3)
|
0.3 (0.6)
|
.01 (0.2)
|
7.5 (0.5)
|
0.2 (0.3)
|
Total
|
520 (100)
|
338 (100)
|
58.8 (100)
|
4.4 (100)
|
1,523.2 (100)
|
58.4 (100)
|
Mortality | DALYs | |||
---|---|---|---|---|
Coefficient ρ | p-value | Coefficient ρ | p-value | |
Worldwide
|
.417
|
.076
|
.490*
|
.033
|
High-income | .485* | .035 | .606** | .006 |
Low- and middle-income | .413 | .079 | .497* | .030 |
EU-25
|
.449
|
.054
|
.619**
|
.005
|
EU-15
|
.492*
|
.032
|
.603**
|
.006
|
Austria | .491* | .033 | .619** | .005 |
Belgium | .554* | .014 | .637** | .003 |
Denmark | .441 | .059 | .562** | .012 |
Finland | .334 | .162 | .376 | .113 |
France | .555* | .014 | .612** | .005 |
Germany | .455 | .050 | .657** | .002 |
Greece | .495* | .031 | .610** | .006 |
Ireland | .484* | .036 | .504* | .028 |
Italy | .455* | .558 | .641** | .003 |
Luxembourg | .558* | .013 | .585** | .008 |
Netherlands | .483* | .036 | .534* | .018 |
Portugal | .476* | .039 | .663** | .002 |
Spain | .518* | .023 | .620** | .005 |
Sweden | .452 | .052 | .550* | .015 |
United Kingdom | .476* | .039 | .564* | .012 |
EU-10
|
.304
|
.206
|
.499*
|
.030
|
Cyprus | .425 | .070 | .627** | .004 |
Czech Republic | .337 | .159 | .487* | .035 |
Estonia | .316 | .188 | .475* | .040 |
Hungary | .373 | .116 | .501* | .029 |
Latvia | .248 | .306 | .513* | .025 |
Lithuania | .207 | .394 | .404 | .086 |
Malta | .328 | .171 | .578** | .010 |
Poland | .304 | .206 | .571* | .011 |
Slovakia | .326 | .173 | .547* | .015 |
Slovenia | .344 | .149 | .492* | .032 |
Characteristics | Num. of PIPs (%) | Num. of NCEs (%) |
---|---|---|
Total | 103 (100) | 95 (100) |
Type of intervention
| ||
Prevention | 11 (10.7) | 8 (8.4) |
Diagnosis | - | - |
Treatment | 85 (82.5) | 80 (84.2) |
Palliative care/rehabilitation | 7 (6.8) | 7 (7.4) |
Disease seriousness
| ||
Serious disease | 73 (70.1) | 66 (69.5) |
Nonserious disease | 20 (19.4) | 19 (20.0) |
Risk factor for serious disease | 10 (9.7) | 10 (10.5) |
New mechanism of action
|
21 (20.4)
|
20 (21.0)
|
Fixed-dose combinations
|
11 (10.7)
|
11 (11.6)
|
Biotechnological/biological product
|
31 (30.1)
|
25 (26.3)
|
Orphan medicinal product
|
16 (15.5)
|
16 (16.8)
|
Disease conditions | Pharmaceutical output related to pediatric needs | Burden of disease in children under 15 years | ||||
---|---|---|---|---|---|---|
PIPs | NCEs | Mortality per 106(%) | DALYs per 106(%) | |||
Number (%) | Number (%) | Worldwide | EU-25 | Worldwide | EU-25 | |
Communicable diseases
|
20 (19.4)
|
19 (20.0)
|
10.1 (84.6)
|
0.1 (43.7)
|
406.5 (74.1)
|
0.9 (24.6)
|
Infectious and parasitic diseases | 12 (11.6) | 12 (12.6) | 4.6 (38.6) | .01 (3.4) | 176.5 (32.2) | 0.1 (3.8) |
Respiratory infections | 5 (4.8) | 4 (4.2) | 2.1 (17.3) | .01 (2.0) | 76.2 (13.9) | .07 (1.9) |
Maternal conditions | 2 (1.9) | 2 (2.1) | .00 (0.0) | .00 (0.0) | 0.5 (0.1) | .00 (0.0) |
Perinatal conditions | 1 (1.0) | 1 (1.0) | 3.2 (26.8) | 0.1 (38.3) | 126.4 (23.1) | 0.6 (16.2) |
Noncommunicable diseases
|
83 (80.6)
|
76 (80.0)
|
1.0 (8.1)
|
0.1 (44.3)
|
93.5 (17.1)
|
2.3 (64.2)
|
Malignant neoplasms | 16 (15.5) | 15 (15.8) | .09 (0.7) | .02 (7.1) | 3.2 (0.6) | .09 (2.4) |
Other neoplasms | - | - | .01 (0.1) | .00 (0.9) | 0.3 (0.1) | .01 (0.3) |
Diabetes mellitus | 9 (8.7) | 7 (7.4) | .01 (0.1) | .00 (0.1) | 0.3 (0.1) | .00 (0.1) |
Blood and endocrine disorders | 15 (14.6) | 14 (14.7) | .05 (0.4) | .01 (3.2) | 3.4 (0.6) | 0.1 (3.8) |
Neuropsychiatric conditions | 9 (8.7) | 9 (9.5) | .08 (0.6) | .02 (4.8) | 30.6 (5.6) | 0.9 (24.6) |
Sense organ diseases | 1 (1.0) | 1 (1.0) | .00 (0.0) | .00 (0.0) | 4.5 (0.8) | 0.1 (3.6) |
Cardiovascular diseases | 12 (11.6) | 11 (11.6) | 0.1 (1.0) | .01 (2.7) | 5.1 (0.9) | .04 (1.1) |
Respiratory diseases | 4 (3.9) | 4 (4.2) | .06 (0.5) | .00 (1.1) | 9.2 (1.7) | 0.3 (9.0) |
Digestive diseases | 2 (1.9) | 1 (1.0) | 0.1 (1.1) | .00 (1.0) | 6.5 (1.2) | .05 (1.7) |
Genitourinary diseases | 2 (1.9) | 2 (2.1) | .03 (0.3) | .00 (0.2) | 1.6 (0.3) | .01 (0.2) |
Skin diseases | 6 (5.8) | 6 (6.3) | .00 (0.0) | .00 (0.0) | 0.9 (0.2) | .00 (0.1) |
Musculoskeletal diseases | 7 (6.8) | 6 (6.3) | .00 (0.0) | .00 (0.2) | 1.6 (0.3) | .03 (0.9) |
Congenital anomalies | - | - | 0.4 (3.3) | .07 (23.1) | 24.1 (4.4) | 0.5 (14.5) |
Oral conditions | - | - | .00 (0.0) | .00 (0.0) | 2.2 (0.4) | .08 (2.2) |
Unintentional injuries (poisoning) | - | - |
.03 (0.3)
|
.00 (0.2)
|
1.2 (0.2)
|
.00 (0.1)
|
Total
|
103 (100)
|
95 (100)
|
11.9 (100)
|
0.3 (100)
|
548.4 (100)
|
3.6 (100)
|