4 Amendments of Esther DE LANGE related to 2012/0192(COD)
Amendment 108 #
Proposal for a regulation
Recital 10
Recital 10
(10) The assessment of the application for a clinical trial should address in particular the anticipated therapeutic and public health benefits (‘relevance’) and the risk and inconveniences for the subject. Regarding the relevance, numerous aspects should be taken into account, includingwhich includes ensuring that the group of subjects participating in the trial represents the population, including women and the elderly, to be treated, and whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products.
Amendment 123 #
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. Subjects from vulnerable population groups such as incapacitated subjects, minors, the elderly or other vulnerable people, require additional protection measures. Regarding the rules concerning the determination of the legal representative of incapacitated persons and minors, those rules diverge in Member States. It should therefore be left to Member States to determine the legal representative of incapacitated personssubjects, the elderly and minors.
Amendment 290 #
Proposal for a regulation
Article 6 – paragraph 1 – point a – point i – indent 2
Article 6 – paragraph 1 – point a – point i – indent 2
– the relevance of the clinical trial, ensuring that the groups of subjects participating in the trials represent the population, including women and the elderly, to be treated, and taking account of the current state of scientific knowledge, and of whether the clinical trial has been recommended or imposed by regulatory authorities in charge of the assessment and authorisation of the placing on the market of medicinal products;
Amendment 382 #
Proposal for a regulation
Article 10 – paragraph 2 a (new)
Article 10 – paragraph 2 a (new)
2a. Where the subjects are from other vulnerable population groups, including the elderly, frail people and people with dementia, specific consideration shall be given to the assessment of the application for the authorisation of a clinical trial on the basis of expertise from professionals in the given field, or after taking advice on clinical, ethical and psychosocial problems in the field.