9 Amendments of Nora BERRA related to 2012/0192(COD)
Amendment 86 #
Proposal for a regulation
Recital 4
Recital 4
(4) Directive 2001/20/EC aimed to simplify and harmonise the administrative provisions governing clinical trials in the European Union. However, experience shows that a harmonised approach to the regulation of clinical trials has only been partly achieved. This makes it in particular difficult to perform a clinical trial in several Member States. Scientific development however, suggests that future clinical trials will target more specific patient populations, such as subgroups identified through genomic information. In order to include a sufficient number of patients for such trials it may be necessary to involve many, or all, Member States. The new procedures for the authorisation of clinical trials should stimulate the inclusion of as many member states as possible. Therefore, in order to simplify submission procedures, the multiple submission of largely identical information should be avoided and replaced by the submission of one application dossier through a single submission portal to all the Member States concerned. Given that clinical trials carried out in a single Member State are equally indispensable to European clinical research, the procedure under this regulation should also cover such trials. The application dossier for such clinical trials should also be sent via the single European portal.
Amendment 124 #
Proposal for a regulation
Recital 22
Recital 22
(22) The human dignity and right to the integrity of the person are recognized in the Charter of Fundamental rights of the European Union. In particular, the Charter requires that any intervention in the field of biology and medicine cannot be performed without free and informed consent of the person concerned. Directive 2001/20/EC contained an extensive set of rules for the protection of subjects. These rules should be upheld. Regarding tThe rules concerning the determination of the legal representative of incapacitated persons and minors, those rulese definition of incapacitated and vulnerable persons and the provisions resulting from that definition, diverge in Member States. It should therefore be left to Member States to determine the legal representative of incapacitated persons and minors and where necessary to enact rules affording greater protection at national level.
Amendment 232 #
Proposal for a regulation
Article 2 – paragraph 2 – point 17
Article 2 – paragraph 2 – point 17
(17) ‘Incapacitated subject’: a subject who is, for other reasons than the age of legal competence to give informed consent, legally legally or de facto incapable of giving informed consent according to the laws of the Member State concerned;
Amendment 262 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
The sponsor shall propose one of the Member States concerned as reporting Member State. The Member States concerned shall be free to choose one of their number as the reporting Member State.
Amendment 266 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3 a (new)
Article 5 – paragraph 1 – subparagraph 3 a (new)
If the sponsor submits an application dossier to just one of the Member States concerned, that Member State shall automatically be designated as the reporting Member State.
Amendment 360 #
Proposal for a regulation
Article 8 – paragraph 2 a (new)
Article 8 – paragraph 2 a (new)
2a. Where the Member State concerned disagrees with the conclusion of the reporting Member State on the basis of points (a) and (b) of the second subparagraph of paragraph 2, the clinical trial shall not take place in the Member State concerned.
Amendment 383 #
Proposal for a regulation
Article 10 – paragraph 2 a (new)
Article 10 – paragraph 2 a (new)
2a. Where the clinical trial concerns other categories of subjects who are considered vulnerable under national law, the application to conduct the clinical trial shall be assessed on the basis of the national law of the Member States concerned.
Amendment 393 #
Proposal for a regulation
Article 13
Article 13
Amendment 508 #
Proposal for a regulation
Article 32 – paragraph 1 – point b
Article 32 – paragraph 1 – point b
(b) nothe consent of the legal representative is availablecannot be given within a period consistent with the methodological requirements of the research;