28 Amendments of Bernadette VERGNAUD related to 2012/0192(COD)
Amendment 56 #
Proposal for a regulation
Article 2 – paragraph 2 – point 1 – introductory part
Article 2 – paragraph 2 – point 1 – introductory part
(1) ‘Clinical studytrial’: any investigation in relation to humans intended:
Amendment 57 #
Proposal for a regulation
Article 2 – paragraph 2 – point 1 – point a
Article 2 – paragraph 2 – point 1 – point a
(a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products; or
Amendment 58 #
Proposal for a regulation
Article 2 – paragraph 2 – point 2
Article 2 – paragraph 2 – point 2
Amendment 64 #
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – point b
Article 2 – paragraph 2 – point 3 – point b
(b) according to the protocol of the clinical trial, the investigational medicinal products are used in accordance with the terms of the marketing authorisation or their use is a standard treatment in any ofin the Member States concerned;
Amendment 66 #
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – point c a (new)
Article 2 – paragraph 2 – point 3 – point c a (new)
(ca) the aim of the study is not that of identifying, characterising or quantifying a safety hazard, confirming the efficacy or safety profile of the medicinal product, or of measuring the effectiveness of risk management measures.
Amendment 67 #
Proposal for a regulation
Article 2 – paragraph 2 – point 4
Article 2 – paragraph 2 – point 4
(4) ‘Non-interventional study’: a clinical study other than a clinical trial;study where the medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study.
Amendment 68 #
Proposal for a regulation
Article 2 – paragraph 2 – point 4 – indent 1 (new)
Article 2 – paragraph 2 – point 4 – indent 1 (new)
- No payment or other advantage or facilities can be made to healthcare professionals in order to encourage them to prescribe, dispense or use a given medicinal product.
Amendment 69 #
Proposal for a regulation
Article 2 – paragraph 2 – point 6
Article 2 – paragraph 2 – point 6
(6) ‘Normal clinical practice’'Best current proven intervention': the treatment regime typically followed to treat, prevent, or diagnose a disease or a disorder; according to the current reliable scientific evidence; (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 73 #
Proposal for a regulation
Article 2 – paragraph 2 – point 12
Article 2 – paragraph 2 – point 12
(12) ‘'Substantial modification’': any change to any aspect of the clinical trial, including early termination of the trial, which is made after notification of the decision referred to in Articles 8, 14, 19, 20 and 23 and which is likely tomay have a substantial impact on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial;, i.e. change the interpretation of the scientific documents used to support the conduct of the trial, or if the modifications are otherwise significant.
Amendment 76 #
Proposal for a regulation
Article 2 – paragraph 2 – point 13
Article 2 – paragraph 2 – point 13
(13) ‘'Sponsor’': an individual, company, institution or organisation which takes responsibility for the initiation and, management and/or financing of the clinical trial;
Amendment 82 #
Proposal for a regulation
Article 2 – paragraph 2 – point 20
Article 2 – paragraph 2 – point 20
(20) ‘Protocol’: a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial. The term protocol refers to the protocol, successive versions of the protocol and protocol amendments;
Amendment 83 #
Proposal for a regulation
Article 2 – paragraph 2 – point 30 a (new)
Article 2 – paragraph 2 – point 30 a (new)
(30a) 'Clinical study report' : a report containing the full protocol and its eventual subsequent modifications and dates thereof, a statistical analysis plan, summarised efficacy and safety data on all outcomes, and individual anonymised patient data in the format of tabulations or listings.
Amendment 85 #
Proposal for a regulation
Article 3 – paragraph 1 – indent 2
Article 3 – paragraph 1 – indent 2
– the data generated in the clinical trial are going to be relevant, reliable and robust.
Amendment 87 #
Proposal for a regulation
Chapter 2 – title
Chapter 2 – title
Amendment 88 #
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Amendment 90 #
Proposal for a regulation
Article 4 b (new)
Article 4 b (new)
Article 4b Best current proven intervention The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances: (a) the use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or (b) where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of the option set out in point (b) of the first subparagraph.
Amendment 91 #
Proposal for a regulation
Article 4 c (new)
Article 4 c (new)
Amendment 92 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1
Article 5 – paragraph 1 – subparagraph 1
In order to obtain an authorisation, the sponsor shall submit an application dossier to the intended Member States concerned through the portal referred to in Article 77 (hereinafter ‘EU portal’).Within six days following submission of the application dossier, Member States shall collectively appoint a reporting Member State and a co- reporting Member State.
Amendment 93 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
Amendment 94 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Amendment 96 #
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. Within six days following submission of the application dossier, the proposedappointment of the reporting Member State, the reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 97 #
Proposal for a regulation
Article 5 – paragraph 2 – point a
Article 5 – paragraph 2 – point a
(a) whether it is the reporting Member State or which other Member State concerned is the co- reporting Member State;
Amendment 98 #
Proposal for a regulation
Article 5 – paragraph 2 – point d a (new)
Article 5 – paragraph 2 – point d a (new)
(da) the clinical trial registration number in the EU portal.
Amendment 99 #
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Where the proposed reporting Member State has not notified the sponsor within the time period referred to in paragraph 2, the clinical trial applied for shall be considered as falling within the scope of this Regulation, the application shall be considered complete, the clinical trial shall be considered a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 124 #
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2 – point a
Article 8 – paragraph 2 – subparagraph 2 – point a
(a) significant differences in normal clinical practice between the Member State concerned and the reporting Member State which would lead to a subject receiving an inferior treatmentcare than in normal clinical practice;
Amendment 125 #
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2 – point b a (new)
Article 8 – paragraph 2 – subparagraph 2 – point b a (new)
(ba) Infringement of more comprehensive national provisions for clinical trial subjects' protection than the provisions of this Regulation, in particular as regards vulnerable populations;
Amendment 127 #
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2 – point b b (new)
Article 8 – paragraph 2 – subparagraph 2 – point b b (new)
(bb) refusal of the Ethics Committee to approve the conduct of the clinical trial in the Member State concerned.
Amendment 131 #
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 3
Article 8 – paragraph 2 – subparagraph 3
Where the Member State concerned disagrees with the conclusion onf the basis of point (a) of the second subparagraph, it shall communicate its disagreement, together with a detailed justification based on scientific and socio-economic arguments, and a summary thereofreporting Member State, it shall communicate its disagreement, through the EU portal to the Commission, to all Member States, and to the sponsor.