Sittings · Compare
What changed
DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION
on the proposal for a regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006
(COM(2023)0193 – C90144/2023 – 2023/0131(COD))
(Ordinary legislative procedure: first reading)
The European Parliament,
– having regard to the Commission proposal to Parliament and the Council (COM(2023)0193),
– having regard to Article 294(2) and Article 114 and Article 168(4), point (c), of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90144/2023),
– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,
– having regard to the opinion of the European Economic and Social Committee of 25 October 2023,
– after consulting the Committee of the Regions,
– having regard to Rule 59 of its Rules of Procedure,
– having regard to the opinion of the Committee on Industry, Research and Energy,
– having regard to the letters from the Committee on Budgets and the Committee on Agriculture and Rural Development,
– having regard to the report of the Committee on the Environment, Public Health and Food Safety (A9-0141/2024),
1. Adopts its position at first reading hereinafter set out;
2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;
3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.
Amendment 1
Proposal for a regulation
Recital -1 (new)
Amendment 2
Proposal for a regulation
Recital 1 a (new)
Amendment 3
Proposal for a regulation
Recital 2
Amendment 4
Proposal for a regulation
Recital 2 a (new)
Amendment 5
Proposal for a regulation
Recital 3
Amendment 6
Proposal for a regulation
Recital 4
Amendment 7
Proposal for a regulation
Recital 5
Amendment 8
Proposal for a regulation
Recital 5 a (new)
Amendment 9
Proposal for a regulation
Recital 6
Amendment 10
Proposal for a regulation
Recital 9
Amendment 11
Proposal for a regulation
Recital 12
Amendment 12
Proposal for a regulation
Recital 13
Amendment 13
Proposal for a regulation
Recital 15
Amendment 14
Proposal for a regulation
Recital 18 a (new)
Amendment 15
Proposal for a regulation
Recital 19
Amendment 16
Proposal for a regulation
Recital 20
Amendment 17
Proposal for a regulation
Recital 20 a (new)
Amendment 18
Proposal for a regulation
Recital 21 a (new)
Amendment 19
Proposal for a regulation
Recital 25
Amendment 20
Proposal for a regulation
Recital 26 a (new)
Amendment 21
Proposal for a regulation
Recital 29
Amendment 22
Proposal for a regulation
Recital 30
Amendment 23
Proposal for a regulation
Recital 31
Amendment 24
Proposal for a regulation
Recital 31 a (new)
Amendment 25
Proposal for a regulation
Recital 33 a (new)
Amendment 26
Proposal for a regulation
Recital 35
Amendment 27
Proposal for a regulation
Recital 36
Amendment 28
Proposal for a regulation
Recital 39
Amendment 29
Proposal for a regulation
Recital 43
Amendment 30
Proposal for a regulation
Recital 43 a (new)
Amendment 31
Proposal for a regulation
Recital 45 a (new)
Amendment 32
Proposal for a regulation
Recital 46
Amendment 33
Proposal for a regulation
Recital 47
Amendment 34
Proposal for a regulation
Recital 51 a (new)
Amendment 35
Proposal for a regulation
Recital 53 a (new)
Amendment 36
Proposal for a regulation
Recital 54
Amendment 37
Proposal for a regulation
Recital 57 a (new)
Amendment 38
Proposal for a regulation
Recital 57 b (new)
Amendment 39
Proposal for a regulation
Recital 58
Amendment 40
Proposal for a regulation
Recital 60
Amendment 41
Proposal for a regulation
Recital 65
Amendment 42
Proposal for a regulation
Recital 67
Amendment 43
Proposal for a regulation
Recital 68 a (new)
Amendment 44
Proposal for a regulation
Recital 76
Amendment 45
Proposal for a regulation
Recital 76 a (new)
Amendment 46
Proposal for a regulation
Recital 77
Amendment 47
Proposal for a regulation
Recital 77 a (new)
Amendment 48
Proposal for a regulation
Recital 77 b (new)
Amendment 49
Proposal for a regulation
Recital 78 a (new)
Amendment 50
Proposal for a regulation
Recital 78 b (new)
Amendment 51
Proposal for a regulation
Recital 78 c (new)
Amendment 52
Proposal for a regulation
Recital 79
Amendment 53
Proposal for a regulation
Recital 80
Amendment 54
Proposal for a regulation
Recital 81
Amendment 55
Proposal for a regulation
Recital 82
Amendment 56
Proposal for a regulation
Recital 83
Amendment 57
Proposal for a regulation
Recital 86
Amendment 58
Proposal for a regulation
Recital 88
Amendment 59
Proposal for a regulation
Recital 90
Amendment 60
Proposal for a regulation
Recital 92
Amendment 61
Proposal for a regulation
Recital 92 a (new)
Amendment 62
Proposal for a regulation
Recital 93
Amendment 63
Proposal for a regulation
Recital 95
Amendment 64
Proposal for a regulation
Recital 103
Amendment 65
Proposal for a regulation
Recital 104
Amendment 66
Proposal for a regulation
Recital 105 a (new)
Amendment 67
Proposal for a regulation
Recital 105 b (new)
Amendment 68
Proposal for a regulation
Recital 112
Amendment 69
Proposal for a regulation
Recital 126
Amendment 70
Proposal for a regulation
Recital 129
Amendment 71
Proposal for a regulation
Recital 132 a (new)
Amendment 72
Proposal for a regulation
Recital 132 b (new)
Amendment 73
Proposal for a regulation
Recital 132 c (new)
Amendment 74
Proposal for a regulation
Recital 133
Amendment 75
Proposal for a regulation
Recital 134
Amendment 76
Proposal for a regulation
Recital 135
Amendment 77
Proposal for a regulation
Recital 135 a (new)
Amendment 78
Proposal for a regulation
Recital 135 b (new)
Amendment 79
Proposal for a regulation
Recital 136
Amendment 80
Proposal for a regulation
Recital 137
Amendment 81
Proposal for a regulation
Recital 138
Amendment 82
Proposal for a regulation
Recital 138 a (new)
Amendment 83
Proposal for a regulation
Recital 138 b (new)
Amendment 84
Proposal for a regulation
Recital 139 a (new)
Amendment 85
Proposal for a regulation
Recital 140
Amendment 86
Proposal for a regulation
Recital 149
Amendment 87
Proposal for a regulation
Recital 155
Amendment 88
Proposal for a regulation
Article 1 – paragraph 1
Amendment 89
Proposal for a regulation
Article 2 – paragraph 2 – point 7
Amendment 90
Proposal for a regulation
Article 2 – paragraph 2 – point 8 – point a
Amendment 91
Proposal for a regulation
Article 2 – paragraph 2 – point 8 – point b
Amendment 92
Proposal for a regulation
Article 2 – paragraph 2 – point 10
Amendment 93
Proposal for a regulation
Article 2 – paragraph 2 – point 12
Amendment 94
Proposal for a regulation
Article 2 – paragraph 2 – point 14 a (new)
Amendment 95
Proposal for a regulation
Article 2 – paragraph 2 – point 14 b (new)
Amendment 96
Proposal for a regulation
Article 5 – paragraph 5
Amendment 97
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 2
Amendment 98
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1
Amendment 99
Proposal for a regulation
Article 6 – paragraph 5 – subparagraph 2
Amendment 100
Proposal for a regulation
Article 7 – paragraph 1
Amendment 101
Proposal for a regulation
Article 8 – paragraph 1 – point b
Amendment 102
Proposal for a regulation
Article 8 – paragraph 1 – point e
Amendment 103
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2
Amendment 104
Proposal for a regulation
Article 9 – paragraph 2
Amendment 105
Proposal for a regulation
Article 10 – paragraph 2
Amendment 106
Proposal for a regulation
Article 12 – paragraph 4 – point g
Amendment 107
Proposal for a regulation
Article 12 – paragraph 4 – point h
Amendment 108
Proposal for a regulation
Article 12 – paragraph 4 – point i
Amendment 109
Proposal for a regulation
Article 12 – paragraph 4 – point j a (new)
Amendment 110
Proposal for a regulation
Article 12 – paragraph 4 – point m a (new)
Amendment 111
Proposal for a regulation
Article 12 – paragraph 4 – point m b (new)
Amendment 112
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 5
Amendment 113
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 6
Amendment 114
Proposal for a regulation
Article 13 – paragraph 4
Amendment 115
Proposal for a regulation
Article 15 – paragraph 1 – point d
Amendment 116
Proposal for a regulation
Article 16 – paragraph 3 – subparagraph 1
Amendment 117
Proposal for a regulation
Article 16 – paragraph 3 – subparagraph 2 – indent 2
Amendment 118
Proposal for a regulation
Article 16 – paragraph 3 – subparagraph 2 – indent 2 a (new)
Amendment 119
Proposal for a regulation
Article 18 – paragraph 1 – introductory part
Amendment 120
Proposal for a regulation
Article 18 – paragraph 2 – subparagraph 2 a (new)
Amendment 121
Proposal for a regulation
Article 19 – paragraph 3
Amendment 122
Proposal for a regulation
Article 19 – paragraph 4
Amendment 123
Proposal for a regulation
Article 19 – paragraph 7 – subparagraph 1 a (new)
Amendment 124
Proposal for a regulation
Article 19 – paragraph 8 – point b
Amendment 125
Proposal for a regulation
Article 19 – paragraph 8 a (new)
Amendment 126
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 – point c a (new)
Amendment 127
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 3
Amendment 128
Proposal for a regulation
Article 20 – paragraph 4
Amendment 129
Proposal for a regulation
Article 24 – paragraph 1 – subparagraph 1
Amendment 130
Proposal for a regulation
Article 24 – paragraph 1 – subparagraph 2 – point f a (new)
Amendment 131
Proposal for a regulation
Article 24 – paragraph 3 a (new)
Amendment 132
Proposal for a regulation
Article 24 – paragraph 4 a (new)
Amendment 133
Proposal for a regulation
Article 24 – paragraph 4 b (new)
Amendment 134
Proposal for a regulation
Article 25 – paragraph 1 – subparagraph 3
Amendment 135
Proposal for a regulation
Article 26 – paragraph 2
Amendment 136
Proposal for a regulation
Article 26 – paragraph 3
Amendment 137
Proposal for a regulation
Article 26 – paragraph 4 – subparagraph 2
Amendment 138
Proposal for a regulation
Article 26 – paragraph 6
Amendment 139
Proposal for a regulation
Article 26 – paragraph 10
Amendment 140
Proposal for a regulation
Article 29 – paragraph 1 a (new)
Amendment 141
Proposal for a regulation
Article 32 – paragraph 1
Amendment 142
Proposal for a regulation
Article 32 – paragraph 2 – subparagraph 1
Amendment 143
Proposal for a regulation
Article 32 – paragraph 3
Amendment 144
Proposal for a regulation
Article 33 – paragraph 2
Amendment 145
Proposal for a regulation
Article 36 – paragraph 1
Amendment 146
Proposal for a regulation
Article 37 – paragraph 1
Amendment 147
Proposal for a regulation
Article 39 a (new)
Amendment 148
Proposal for a regulation
Article 39 b (new)
Amendment 149
Proposal for a regulation
Article 40 – paragraph 1
Amendment 150
Proposal for a regulation
Article 40 – paragraph 2
Amendment 151
Proposal for a regulation
Article 40 – paragraph 2 a (new)
Amendment 152
Proposal for a regulation
Article 40 – paragraph 3
Amendment 153
Proposal for a regulation
Article 40 – paragraph 4 – subparagraph 1 – point a
Amendment 154
Proposal for a regulation
Article 40 – paragraph 4 – subparagraph 1 – point b
Amendment 155
Proposal for a regulation
Article 40 – paragraph 4 – subparagraph 1 – point b a (new)
Amendment 156
Proposal for a regulation
Article 40 – paragraph 4 – subparagraph 1 – point b b (new)
Amendment 157
Proposal for a regulation
Article 40 – paragraph 4 a (new)
Amendment 158
Proposal for a regulation
Article 41 – paragraph 1 – subparagraph 1
Amendment 159
Proposal for a regulation
Article 41 – paragraph 1 – subparagraph 2
Amendment 160
Proposal for a regulation
Article 41 – paragraph 3
Amendment 161
Proposal for a regulation
Article 41 – paragraph 3 a (new)
Amendment 162
Proposal for a regulation
Article 42 – paragraph 1 – point b
Amendment 163
Proposal for a regulation
Article 42 – paragraph 2
Amendment 164
Proposal for a regulation
Article 43 – paragraph 1
Amendment 165
Proposal for a regulation
Article 43 – paragraph 1 a (new)
Amendment 166
Proposal for a regulation
Article 45 – paragraph 4 – subparagraph 1
Amendment 167
Proposal for a regulation
Article 47 – paragraph 1
Amendment 168
Proposal for a regulation
Article 48 – paragraph 1 – subparagraph 1
Amendment 169
Proposal for a regulation
Article 48 – paragraph 1 – subparagraph 2
Amendment 170
Proposal for a regulation
Article 48 – paragraph 1 – subparagraph 3
Amendment 171
Proposal for a regulation
Article 48 – paragraph 3
Amendment 172
Proposal for a regulation
Article 52 – paragraph 2 – subparagraph 1 – point a
Amendment 173
Proposal for a regulation
Article 53 – paragraph 2
Amendment 174
Proposal for a regulation
Article 56 – paragraph 2 a (new)
Amendment 175
Proposal for a regulation
Article 58 – paragraph 3
Amendment 176
Proposal for a regulation
Article 58 – paragraph 4
Amendment 177
Proposal for a regulation
Article 58 – paragraph 4 a (new)
Amendment 178
Proposal for a regulation
Article 60 – paragraph 1 – introductory part
Amendment 179
Proposal for a regulation
Article 60 – paragraph 1 – point c
Amendment 180
Proposal for a regulation
Article 60 – paragraph 4 a (new)
Amendment 181
Proposal for a regulation
Article 61 – paragraph 1 – subparagraph 1
Amendment 182
Proposal for a regulation
Article 61 – paragraph 2 – subparagraph 1
Amendment 183
Proposal for a regulation
Article 61 – paragraph 2 – subparagraph 3
Amendment 184
Proposal for a regulation
Article 61 – paragraph 2 – subparagraph 3 a (new)
Amendment 185
Proposal for a regulation
Article 62 – paragraph 1 – subparagraph 1
Amendment 186
Proposal for a regulation
Article 62 – paragraph 2
Amendment 187
Proposal for a regulation
Article 62 – paragraph 3
Amendment 188
Proposal for a regulation
Article 63 – paragraph 2
Amendment 189
Proposal for a regulation
Article 64 – paragraph 2 – subparagraph 1 – point d
Amendment 190
Proposal for a regulation
Article 64 – paragraph 4 – subparagraph 1
Amendment 191
Proposal for a regulation
Article 65 – paragraph 2 – point c a (new)
Amendment 192
Proposal for a regulation
Article 66 – paragraph 5
Amendment 193
Proposal for a regulation
Article 67 – paragraph 3 – point f a (new)
Amendment 194
Proposal for a regulation
Article 68 – paragraph 1 – introductory part
Amendment 195
Proposal for a regulation
Article 68 – paragraph 1 – point a
Amendment 196
Proposal for a regulation
Article 68 – paragraph 2
Amendment 197
Proposal for a regulation
Article 69 – paragraph 2 – subparagraph 1
Amendment 198
Proposal for a regulation
Article 69 – paragraph 3 – subparagraph 1
Amendment 199
Proposal for a regulation
Article 69 – paragraph 4
Amendment 200
Proposal for a regulation
Article 69 – paragraph 6
Amendment 201
Proposal for a regulation
Article 70 – paragraph 1 – point a
Amendment 202
Proposal for a regulation
Article 70 – paragraph 1 – point b
Amendment 203
Proposal for a regulation
Article 70 – paragraph 3
Amendment 204
Proposal for a regulation
Article 71 – paragraph 2 – point b
Amendment 205
Proposal for a regulation
Article 71 – paragraph 2 – point c
Amendment 206
Proposal for a regulation
Article 71 – paragraph 5
Amendment 207
Proposal for a regulation
Article 71 – paragraph 6
Amendment 208
Proposal for a regulation
Article 72 – paragraph 1
Amendment 209
Proposal for a regulation
Article 73 a (new)
Amendment 210
Proposal for a regulation
Article 73 b (new)
Amendment 211
Proposal for a regulation
Article 74 – paragraph 2 – subparagraph 1 – point b
Amendment 212
Proposal for a regulation
Article 74 – paragraph 3
Amendment 213
Proposal for a regulation
Article 75 – paragraph 1 – point b
Amendment 214
Proposal for a regulation
Article 75 – paragraph 3
Amendment 215
Proposal for a regulation
Article 75 – paragraph 3 a (new)
Amendment 216
Proposal for a regulation
Article 81 – paragraph 3
Amendment 217
Proposal for a regulation
Article 84 – paragraph 1 a (new)
Amendment 218
Proposal for a regulation
Article 84 – paragraph 2 – subparagraph 1
Amendment 219
Proposal for a regulation
Article 84 – paragraph 2 a (new)
Amendment 220
Proposal for a regulation
Article 84 – paragraph 2 b (new)
Amendment 221
Proposal for a regulation
Article 88 – paragraph 1
Amendment 222
Proposal for a regulation
Article 91 – paragraph 3
Amendment 223
Proposal for a regulation
Article 101 – paragraph 1 – subparagraph 3
Amendment 224
Proposal for a regulation
Article 101 – paragraph 2 – subparagraph 5
Amendment 225
Proposal for a regulation
Article 101 – paragraph 2 – subparagraph 6
Amendment 226
Proposal for a regulation
Article 101 – paragraph 3 a (new)
Amendment 227
Proposal for a regulation
Article 104 – paragraph 1 – subparagraph 1 – introductory part
Amendment 228
Proposal for a regulation
Article 104 – paragraph 1 – subparagraph 1 – point c
Amendment 229
Proposal for a regulation
Article 104 – paragraph 1 – subparagraph 1 – point h
Amendment 230
Proposal for a regulation
Article 104 – paragraph 1 – subparagraph 1 – point i
Amendment 231
Proposal for a regulation
Article 104 – paragraph 1 – subparagraph 1 – point j
Amendment 232
Proposal for a regulation
Article 104 – paragraph 1 – subparagraph 2
Amendment 233
Proposal for a regulation
Article 104 – paragraph 2
Amendment 234
Proposal for a regulation
Article 104 – paragraph 3 – subparagraph 1
Amendment 235
Proposal for a regulation
Article 104 – paragraph 3 – subparagraph 2
Amendment 236
Proposal for a regulation
Article 105 – paragraph 3
Amendment 237
Proposal for a regulation
Article 109 – paragraph 2
Amendment 238
Proposal for a regulation
Article 111 – paragraph 1
Amendment 239
Proposal for a regulation
Article 113 – paragraph 1 – introductory part
Amendment 240
Proposal for a regulation
Article 113 – paragraph 3
Amendment 241
Proposal for a regulation
Article 113 – paragraph 4 – subparagraph 1
Amendment 242
Proposal for a regulation
Article 113 – paragraph 5
Amendment 243
Proposal for a regulation
Article 113 – paragraph 6
Amendment 244
Proposal for a regulation
Article 113 – paragraph 8 – subparagraph 1 – point b
Amendment 245
Proposal for a regulation
Article 113 – paragraph 9
Amendment 246
Proposal for a regulation
Article 114 – paragraph 2
Amendment 247
Proposal for a regulation
Article 114 – paragraph 3
Amendment 248
Proposal for a regulation
Article 115 – paragraph 1 – subparagraph 2
Amendment 249
Proposal for a regulation
Article 115 – paragraph 4
Amendment 250
Proposal for a regulation
Article 116 – paragraph 1 – introductory part
Amendment 251
Proposal for a regulation
Article 116 – paragraph 1 – point c
Amendment 252
Proposal for a regulation
Article 116 – paragraph 1 – point d
Amendment 253
Proposal for a regulation
Article 117 – paragraph 1
Amendment 254
Proposal for a regulation
Article 117 – paragraph 2
Amendment 255
Proposal for a regulation
Article 118 – paragraph 1 – subparagraph 1
Amendment 256
Proposal for a regulation
Article 118 – paragraph 1 a (new)
Amendment 257
Proposal for a regulation
Article 118 – paragraph 2
Amendment 258
Proposal for a regulation
Article 120 – paragraph 1
Amendment 259
Proposal for a regulation
Article 120 – paragraph 1 a (new)
Amendment 260
Proposal for a regulation
Article 121 – paragraph 1 – point -a (new)
Amendment 261
Proposal for a regulation
Article 121 – paragraph 1 – point b
Amendment 262
Proposal for a regulation
Article 121 – paragraph 1 – point b a (new)
Amendment 263
Proposal for a regulation
Article 121 – paragraph 1 – point c a (new)
Amendment 264
Proposal for a regulation
Article 121 – paragraph 1 – point c b (new)
Amendment 265
Proposal for a regulation
Article 121 – paragraph 2 – point f
Amendment 266
Proposal for a regulation
Article 121 – paragraph 2 a (new)
Amendment 267
Proposal for a regulation
Article 121 – paragraph 5 – point a
Amendment 268
Proposal for a regulation
Article 121 – paragraph 5 – point d
Amendment 269
Proposal for a regulation
Article 121 – paragraph 6
Amendment 270
Proposal for a regulation
Article 121 a (new)
Amendment 271
Proposal for a regulation
Article 122 – paragraph 1
Amendment 272
Proposal for a regulation
Article 122 – paragraph 1 a (new)
Amendment 273
Proposal for a regulation
Article 122 – paragraph 2 a (new)
Amendment 274
Proposal for a regulation
Article 122 – paragraph 4 – introductory part
Amendment 275
Proposal for a regulation
Article 122 – paragraph 6
Amendment 276
Proposal for a regulation
Article 123 – paragraph 2
Amendment 277
Proposal for a regulation
Article 123 – paragraph 4
Amendment 278
Proposal for a regulation
Article 123 – paragraph 4 – subparagraph 1 a (new)
Amendment 279
Proposal for a regulation
Article 124 – paragraph 2 – subparagraph 2
Amendment 280
Proposal for a regulation
Article 124 – paragraph 3
Amendment 281
Proposal for a regulation
Article 125 – paragraph 1 – point a
Amendment 282
Proposal for a regulation
Article 125 – paragraph 1 – point f
Amendment 283
Proposal for a regulation
Article 126 – paragraph 2 a (new)
Amendment 284
Proposal for a regulation
Article 127 – paragraph 1
Amendment 285
Proposal for a regulation
Article 128 – paragraph 2
Amendment 286
Proposal for a regulation
Article 129 – paragraph 1
Amendment 287
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – point a
Amendment 288
Proposal for a regulation
Article 130 – paragraph 2 – subparagraph 1 – point b
Amendment 289
Proposal for a regulation
Article 130 – paragraph 5
Amendment 290
Proposal for a regulation
Article 130 – paragraph 6 a (new)
Amendment 291
Proposal for a regulation
Article 131 – paragraph 1
Amendment 292
Proposal for a regulation
Article 131 – paragraph 2
Amendment 293
Proposal for a regulation
Article 132 – paragraph 1
Amendment 294
Proposal for a regulation
Article 132 – paragraph 1 a (new)
Amendment 295
Proposal for a regulation
Article 132 – paragraph 1 b (new)
Amendment 296
Proposal for a regulation
Article 134 – paragraph 1 – introductory part
Amendment 297
Proposal for a regulation
Article 134 – paragraph 1 – point -a (new)
Amendment 298
Proposal for a regulation
Article 134 – paragraph 1 – point c a (new)
Amendment 299
Proposal for a regulation
Article 134 – paragraph 1 – point c b (new)
Amendment 300
Proposal for a regulation
Article 134 – paragraph 1 a (new)
Amendment 301
Proposal for a regulation
Article 134 – paragraph 2
Amendment 302
Proposal for a regulation
Article 134 – paragraph 3
Amendment 303
Proposal for a regulation
Article 138 – paragraph 1 – subparagraph 1
Amendment 304
Proposal for a regulation
Article 138 – paragraph 1 – subparagraph 2 – introductory part
Amendment 305
Proposal for a regulation
Article 138 – paragraph 1 – subparagraph 2 – point a
Amendment 306
Proposal for a regulation
Article 138 – paragraph 1 – subparagraph 2 – point a a (new)
Amendment 307
Proposal for a regulation
Article 138 – paragraph 1 – subparagraph 2 – point b
Amendment 308
Proposal for a regulation
Article 138 – paragraph 1 – subparagraph 2 – point c
Amendment 309
Proposal for a regulation
Article 138 – paragraph 1 – subparagraph 2 – point n
Amendment 310
Proposal for a regulation
Article 138 – paragraph 1 – subparagraph 2 – point zc
Amendment 311
Proposal for a regulation
Article 138 – paragraph 1 – subparagraph 2 – point ze
Amendment 312
Proposal for a regulation
Article 138 – paragraph 1 – subparagraph 2 – point zl a (new)
Amendment 313
Proposal for a regulation
Article 138 – paragraph 2 – subparagraph 1
Amendment 314
Proposal for a regulation
Article 138 – paragraph 2 – subparagraph 2 – point b a (new)
Amendment 315
Proposal for a regulation
Article 138 – paragraph 2 – subparagraph 3
Amendment 316
Proposal for a regulation
Article 142 – paragraph 1 – point l
Amendment 317
Proposal for a regulation
Article 143 – paragraph 1 – subparagraph 2
Amendment 318
Proposal for a regulation
Article 143 – paragraph 2 – subparagraph 2
Amendment 319
Proposal for a regulation
Article 143 – paragraph 4
Amendment 320
Proposal for a regulation
Article 143 – paragraph 4 a (new)
Amendment 321
Proposal for a regulation
Article 146 – paragraph 8 – subparagraph 1
Amendment 322
Proposal for a regulation
Article 147 – title
Amendment 323
Proposal for a regulation
Article 147 – paragraph 1 – subparagraph 2
Amendment 324
Proposal for a regulation
Article 147 – paragraph 2
Amendment 325
Proposal for a regulation
Article 147 – paragraph 2 a (new)
Amendment 326
Proposal for a regulation
Article 147 – paragraph 2 b (new)
Amendment 327
Proposal for a regulation
Article 147 – paragraph 2 c (new)
Amendment 328
Proposal for a regulation
Article 150 – title
Amendment 329
Proposal for a regulation
Article 150 – paragraph 2 – subparagraph 3
Amendment 330
Proposal for a regulation
Article 150 – paragraph 3 – subparagraph 1 – point b a (new)
Amendment 331
Proposal for a regulation
Article 150 – paragraph 3 a (new)
Amendment 332
Proposal for a regulation
Article 150 – paragraph 5 a (new)
Amendment 333
Proposal for a regulation
Article 151 – paragraph 3 – subparagraph 1
Amendment 334
Proposal for a regulation
Article 152 – paragraph 2 – subparagraph 2
Amendment 335
Proposal for a regulation
Article 153 – paragraph 1
Amendment 336
Proposal for a regulation
Article 154 – paragraph 4
Amendment 337
Proposal for a regulation
Article 162 – paragraph 2
Amendment 338
Proposal for a regulation
Article 163 – paragraph 1
Amendment 339
Proposal for a regulation
Article 164 – paragraph 5
Amendment 340
Proposal for a regulation
Article 165 – paragraph 3 a (new)
Amendment 341
Proposal for a regulation
Article 166 – paragraph 1
Amendment 342
Proposal for a regulation
Article 166 – paragraph 1 – subparagraph 1 a (new)
Amendment 343
Proposal for a regulation
Article 166 – paragraph 2
Amendment 344
Proposal for a regulation
Article 167 – paragraph 2
Amendment 345
Proposal for a regulation
Article 168 – paragraph 1
Amendment 346
Proposal for a regulation
Article 169 – paragraph 1 – subparagraph 2 – point b
Amendment 347
Proposal for a regulation
Article 171 – paragraph 1
Amendment 348
Proposal for a regulation
Article 172 – paragraph 5 – point b a (new)
Amendment 349
Proposal for a regulation
Article 172 – paragraph 5 – point b b (new)
Amendment 350
Proposal for a regulation
Article 172 – paragraph 5 – point b c (new)
Amendment 351
Proposal for a regulation
Article 172 – paragraph 5 – point b d (new)
Amendment 352
Proposal for a regulation
Article 172 – paragraph 5 – point b e (new)
Amendment 353
Proposal for a regulation
Article 172 – paragraph 5 – point b f (new)
Amendment 354
Proposal for a regulation
Article 172 – paragraph 5 – point b g (new)
Amendment 355
Proposal for a regulation
Article 172 – paragraph 5 – point b h (new)
Amendment 356
Proposal for a regulation
Article 175 a (new) – paragraph 1 – point 1
Regulation (EC) No 851/2004
Articles 11a a (new) and 11a b (new)
Amendment 357
Proposal for a regulation
Article 175 a (new) – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 13 – paragraph 1 – point b a (new)
Amendment 358
Proposal for a regulation
Article 175 a (new) – paragraph 1 – point 3
Regulation (EC) No 851/2004
Article 16 – paragraph 2 – point d a (new)
Amendment 359
Proposal for a regulation
Article 175 a (new) – paragraph 1 – point 4
Regulation (EC) No 851/2004
Articles 17 a (new) and 17 b (new)
Amendment 360
Proposal for a regulation
Article 175 a (new) – paragraph 1 – point 5
Regulation (EC) No 851/2004
Article 19
Amendment 361
Proposal for a regulation
Article 181 – paragraph 3 a (new)
Amendment 362
Proposal for a regulation
Annex II – point 16
Amendment 363
Proposal for a regulation
Annex II – point 25 a (new)
Amendment 364
Proposal for a regulation
Annex II – point 25 b (new)
Amendment 365
Proposal for a regulation
Annex IV – Part III – paragraph 1 – point 2 – point e
Amendment 366
Proposal for a regulation
Annex IV – Part V – paragraph 1 – point 2 – point d a (new)
Amendment 367
Proposal for a regulation
Annex IV – Part V a (new)
EXPLANATORY STATEMENT
The Rapporteur welcomes the long-awaited proposals on both the pharmaceutical Regulation and the Directive as a centrepiece of the European Health Union, which provide a much-needed revision for the crucial legislative framework providing the pharmaceutical rules in the Union. Given that the provisions set out in both the Regulation and Directive are intrinsically interconnected, the Rapporteur considers it essential that these legal texts are considered closely together.
This revision will help the Union to provide a high level of public health by ensuring quality, safety, and efficacy of medicinal products for European patients. Furthermore, it will be a step towards securing timely and equitable access for patients across all Member States. The Rapporteur is committed to delivering on the overarching objectives of ensuring greater accessibility, affordability, and availability of medicinal products for patients across the whole Union.
Furthermore, the Rapporteur welcomes the stepping away from the model of “one-size-fits-all" towards a stepwise approach of incentive models, where actual innovation is promoted and rewarded. The Rapporteur further builds on this principle in his approach to amendments on the modulation of incentives.
Increasingly in the past years the European Union has experienced occasions of shortages of critical and essential medicinal products, to the detriment of patients across the EU. The measures proposed by the European Commission are therefore very much welcomed, as we will be setting a framework to counter shortages, react efficiently and in a coordinated matter. Measures introduced include shortage management and security of supply of medicinal products and in particular critical medicinal products. Further developing the tasks and responsibilities of the EMA towards shortage prevention is another positive addition in the text.
In a similar vein, the Rapporteur is positive regarding the enhanced provisions on the Environmental Risk Assessment proposed by the Commission and the proposed restructuring of the European Medicines Agency that will facilitate streamlined procedures and accelerated marketing authorisations.
The Rapporteur is also dubious of Chapter IX of the proposal which introduces a regulatory sandbox for medicinal products. Firstly, the rapporteur considers the provisions in the Commission’s proposal vague in nature and has not been satisfied with explanations or examples of which types of products could be eligible for such a regulatory sandbox. The rapporteur also bases his decision of the deletion of this chapter after consultation with several stakeholders, and notably industry actors who expressed reluctance with the introduction of another parallel regulatory framework. The Rapporteur and several stakeholders consider that the frameworks within the pharmaceutical rules are broad and encompassing. There is concern that such a sandbox could provide a way of circumventing rules and obligations laid down in the other frameworks provided for in the Regulation. Additionally, the rapporteur would oppose derogations from the requirements set out in both the Regulation and the Directive, particularly with regards to the Environmental Risk Assessment.
Furthermore, the Rapporteur also perceives shortcomings within the Commission proposal, notably on incentives for the development of priority antimicrobials.
Antimicrobial resistance is a rapidly increasing public health threat, already responsible for 35,000 deaths annually in the EU alone and 1.3 million deaths globally. In this regard, the Rapporteur recognises the severity of this issue and the need for the creation of new priority microbials as envisaged in the Regulation. It is also the conviction of the rapporteur that the EU must take action to prevent excessive use of antimicrobials and pharmaceutical waste in the environment, which contribute to the proliferation of antimicrobial resistance. However, the Rapporteur expresses severe scepticism towards the proposed solution of the Transferable Exclusivity Voucher (TEV) which are an indirect and non-transparent form pricing which will cost national health budgets in an unpredictable manner and delay the entry of generic medicines to the market, to the detriment of patients. It is incomprehensible to the Rapporteur that the Commission would propose such a measure without even the accompanying requirement and conditionality to guarantee supply of the priority antimicrobial from which the voucher was awarded. Additionally, the Rapporteur feels that safeguards are missing for the continuous supply of the antimicrobial after the voucher has been sold to another company.
In the absence of the TEV, the Rapporteur proposes the establishment of the ‘European Medicines Facility’ (EMF) as a Union Agency. The EMF should set out specific purpose led R&D projects focusing on health priorities in the public interest at a Union level. These projects should follow a strategic roadmap addressing priority antimicrobials, as well as medicinal products addressing high unmet medical needs and unmet medical needs which have not been sufficiently addressed by the private sector and where the private R&D pipeline is unlikely to deliver on medicinal products and therapies. The Rapporteur introduces the overarching idea of the EMF in this draft report and will further supplement the proposal in later amendments.
Additionally, the Rapporteur considers it necessary and complementary to mandate the Commission to establish a Union push and pull incentives scheme as an additional measure to incentivise the development of novel antibiotics which could include the likes of market-entry rewards, ‘play or pay’ fees, or subscription payment mechanisms.
This report also includes several smaller tweaks and more adaptations of a technical nature. However, the Rapporteur would like to briefly highlight increased emphasis on the involvement of patients and consumer organisations and the strengthening of provisions on transparency and conflicts of interests throughout the text.
Given the time constraints in the preparation of this draft report, the Rapporteur reserves the right to further amend and supplement this draft report with additional measures, clarifications and to further develop ideas introduced in the text. The Rapporteur is looking forward to engaging constructively with all shadow rapporteurs on this Regulation and equally the rapporteur and shadows on the Directive where coordination is necessary.
The list in the Annex of entities or persons from whom the rapporteur has received input from contains all contributions received, even if not all of it has been used in order to draft the report. Additionally, all meetings in regard to the Regulation can be found on the dedicated profile of the Rapporteur on the website of the European Parliament.
ANNEX: LIST OF ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT
Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur declares that he has received input from the following entities or persons in the preparation of the draft report , until the adoption thereof in committee:
The list above is drawn up under the exclusive responsibility of the rapporteur.
22.2.2024
OPINION OF THE COMMITTEE ON INDUSTRY, RESEARCH AND ENERGY
for the Committee on the Environment, Public Health and Food Safety
on the proposal for a regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006
(COM(2023)0193 – C90144/2023 – 2023/0131(COD))
Rapporteur for opinion (*): Henna Virkkunen
(*) Associated committee – Rule 57 of the Rules of Procedure
SHORT JUSTIFICATION
ANNEX: ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR for the OPINION HAS RECEIVED INPUT
PROCEDURE – COMMITTEE ASKED FOR OPINION
FINAL VOTE BY ROLL CALL IN COMMITTEE ASKED FOR OPINION
23.2.2024
LETTER OF THE COMMITTEE ON BUDGETS
Mr Pascal Canfin
Chair
Committee on the Environment, Public Health and Food Safety
BRUSSELS
Subject: Opinion on Opinion on the Commission proposal on a Regulation of the European Parliament and of the Council on for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency COM(2023)0193; (2023/0131(COD)).
Dear Mr Chair,
Under the procedure referred to above, the Committee on Budgets’ Coordinators decided at their meeting of 23 May 2023 to adopt an opinion in the form of a letter. The committee adopted the opinion at its meeting on 14/02/2024 and mandated me to convey the position set out below.
Background to the proposal
The general objective of the proposal is to guarantee a high level of public health by ensuring the quality, safety and efficacy of medicines for EU patients and harmonise the internal market and more specifically to:
1. Promote innovation, in particular for unmet medical needs, including for rare disease patients and children.
2. Create a balanced system for pharmaceuticals in the EU that promotes affordability for health systems while rewarding innovation.
3. Ensure access to innovative and established medicines for patients, with special attention to enhancing security of the supply across the EU.
4. Reduce the environmental impact of the pharmaceutical product life cycle.
5. Reduce the regulatory burden and provide a flexible regulatory framework.
According to the legislative financial statement accompanying the Proposal on a Regulation of the European Parliament and of the Council on for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, the budgetary implications are mainly related to additional tasks to be carried out by the European Medicines Agency in terms of providing scientific, administrative and IT support in the following main areas:
– enhanced pre-authorisation scientific and regulatory support;
– decision-making on orphan designations and management of the Union Register of designated orphan medicinal products;
– active substance master file assessment and certification;
– inspection capacities for inspections in third countries and support to Member States;
– environmental risk assessment strengthening;
– shortage management and security of supply.
The proposal foresees that most of the foreseen additional tasks of EMA will be carried out by 54 additional Temporary Agents funded by fees while other 6 additional Temporary Agents and the costs for the incentives to “not-for-profit” entities will be financed through an increase of the appropriations from the EU budget in the years 2026 and 2027 by 4.4 million EUR and an internal redeployment within heading 2b, i.e. by an equal reduction of EU4Health programme. According to the information provided by the Commission at different budgetary trilogues, this constitutes the second reinforcement of EMA since the start of the MFF and the third reduction of the EU4Health programme since the start of the MFF.
Position of the Committee on Budgets
The BUDG committee is of the general opinion that entrusting new tasks to decentralised agencies should be financed from fresh resources and should not lead to reduce other equally important priorities to be implemented in other programmes even if in the same policy area, in this case Health. Thus, redeployments from the EU4Health programme should be limited and examined with due care. Furthermore, the overall proposed increase in temporary agents is significant (around 7% above the level agreed in the 2024 budget) which deserves special attention as no full coverage by fees as planned would significantly further impact the Union budget.
In this context, we deem useful to provide the ENVI Committee with technical support throughout the process including with a view to assessing the budgetary impact of any decisions of the co-legislators and prevent further carve-outs from the U4Health programme.
In the event of new evidence or changes to this approach introduced by the co-legislators during the negotiations, the Committee on Budgets stands ready to assess the potential budgetary consequences.
Yours sincerely,
Johan Van Overtveldt
ANNEX: ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT
The rapporteur declares under his exclusive responsibility that he did not receive input from any entity or person to be mentioned in this Annex pursuant to Article 8 of Annex I to the Rules of Procedure.
09.01.2024
LETTER OF THE COMMITTEE ON AGRICULTURE AND RURAL DEVELOPMENT
Mr Pascal Canfin
Chair of the Committee on the Environment, Public Health and Food Safety
Brussels
IPOL-COM-AGRI D(2023) 43992
Subject: Opinion on the Proposal for a Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 (COM(2023)0193 – C90144 – 2023/0131(COD))
Dear Mr Canfin,
Under the procedure referred to above, the Committee on Agriculture and Rural Development (AGRI) has been asked to submit an opinion to your committee. At its meeting of 23 May 2023, the committee decided to issue an opinion in the form of a letter and adopted it on 24 January 2023.
The main reason the AGRI Committee send an opinion relates to its competence over veterinary matters as set out in paragraph 3(a) of Annex VI(XIII) of the Rules of Procedures.
Governance of the European Medicinal Agency
AGRI Committee welcomes the simplification of functionning of the Agency which can bring benefits to its work, inclusing in veterinary medicinal products; recalls that appropriate funding is important to ensure effective regulatory control, while enabling innovation and availability of medicinal products.
Antimicrobial resistance and prudent use of veterinary medecines
AGRI Committee welcomes the incentives for developing ‘priority antimicrobials’; stresses that in order for all users to have continued recourse to a full range of effective antimicrobials, for both human and animal health, antibiotics should be developped, marketed, delivered and used responsibly and prudently in line with the “One Health” approach and Regulations (EU) 2019/5 and (EU) 2019/6; highlights the urgent need to bring new antibiotics onto the market, while maintaining high levels of health and safety; calls for better implementing existing approaches against antimicrobial resistance including prevention and surveillance, and innovating new ones;
Free Trade Agreements and reciprocity of norms.
AGRI Committee strongly calls for equivalent measures to those laid down in this proposal, on veterinary products for Union trade partners, to be inserted when negotiating free trade agreements; considers that no veterinary products nor animal products should be imported without a strict reciprocity of norms.
I would be grateful if the ENVI committee could take into account the above considerations in view of the adoption of its report on the Commission proposal in question.
Yours sincerely,
Norbert Lins
ANNEX: ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT
The rapporteur declares under his exclusive responsibility that he did not receive input from any entity or person to be mentioned in this Annex pursuant to Article 8 of Annex I to the Rules of Procedure.
PROCEDURE – COMMITTEE RESPONSIBLE
FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE