28 Amendments of Michèle RIVASI related to 2012/0192(COD)
Amendment 56 #
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – point a
Article 2 – paragraph 2 – point 3 – point a
(a) the investigational medicinal products arehave been authorised for at least ten years;
Amendment 57 #
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – point a a (new)
Article 2 – paragraph 2 – point 3 – point a a (new)
(aa) the investigational medicinal products are not products subject to additional monitoring, indentified by a black symbol;
Amendment 59 #
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 60 #
Proposal for a regulation
Article 2 – paragraph 2 – point 4
Article 2 – paragraph 2 – point 4
(4) ‘'Non-interventional study’': a clinical study owhere the patient is already receiving treatment prior to their than a clinical trial; inclusion in the study and so the assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice, so that 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 28 a (new)
Article 2 – paragraph 2 – point 28 a (new)
(28a) 'Adverse reaction': all untoward and unintended responses to an investigational medicinal product related to any dose administered;
Amendment 79 #
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
Amendment 92 #
Proposal for a regulation
Recital 8
Recital 8
(8) The timelines for assessing an application dossier for clinical trials should be sufficiently long to assess the file, while ensuring quick access to new, innovative treatments and ensuring that the Union remains an attractive place for conducting clinical trials. Against this background, Directive 2001/20/EC introduced the concept of tacit authorisationimplicit authorisation if there has been a vote in favour by the ethics committee and the competent authority has not objected within the deadline. This concept should be maintained in order to ensure that timelines are adhered to. In the event of a public health crisis, Member States should have the possibility to assess and authorise a clinical trial application swiftly. NIn the event of a public health crisis no minimal timelines for approval should therefore be established.
Amendment 150 #
Proposal for a regulation
Article 53 – paragraph 1
Article 53 – paragraph 1
1. All clinical trial information shall be recorded, processed, handled, and stored in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal data of the subjects remain protected in accordance with the applicable legislation on personal data protection, with easily searchable clinical study reports being publicly available online.
Amendment 152 #
Proposal for a regulation
Article 55 – paragraph 1
Article 55 – paragraph 1
Amendment 154 #
Proposal for a regulation
Article 73 – paragraph 1
Article 73 – paragraph 1
1. Member States shall provide for a national indemnification mechanism for compensating damage as referred to in Article 72. It shall be funded for through fees, and no public money shall be used.
Amendment 155 #
Proposal for a regulation
Article 73 – paragraph 3 – subparagraph 1
Article 73 – paragraph 3 – subparagraph 1
Amendment 156 #
Proposal for a regulation
Article 73 – paragraph 3 – subparagraph 2
Article 73 – paragraph 3 – subparagraph 2
Amendment 182 #
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 (Horizontal amendment applying throughout the text. Adopting it will necessitate corresponding changes.)
Amendment 185 #
Proposal for a regulation
Article 2 – paragraph 2 – point 1 – point c a (new)
Article 2 – paragraph 2 – point 1 – point c a (new)
(ca) to conduct a post-marketing safety or post-marketing efficacy trial on a medicinal product authorised within the last 10 years.
Amendment 186 #
Proposal for a regulation
Article 2 – paragraph 2 – point 2
Article 2 – paragraph 2 – point 2
Amendment 203 #
Proposal for a regulation
Article 2 – paragraph 2 – point 3 – point a
Article 2 – paragraph 2 – point 3 – point a
(a) the investigational medicinal products arehave been authorised for more than 10 years;
Amendment 214 #
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 products are prescribed in the usual manner in accordance with the terms of the marketing authorisation and where the assignment of the patient to a particular therapeutic strategy falls within current practice and is not decided in advance by a trial protocol; the prescription of the medicine is clearly separated from the decision to include the patient in the study.
Amendment 223 #
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 a change in number of subjects participating in the trial, which is made after notification of the decision referred to in Articles 8, 14, 19, 20 and 23 and which is likely tocould 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; or could change the interpretation of the scientific documents used to support the conduct of the trial, or any other change to any aspect of the clinical trial that is otherwise significant.
Amendment 250 #
Proposal for a regulation
Article 3 – paragraph 1 – indent 2 a (new)
Article 3 – paragraph 1 – indent 2 a (new)
- the data generated in the clinical trial address a documented gap in scientific knowledge that could not be acquired through other means.
Amendment 254 #
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Article 4a Ethics Committee An authorisation for the conduct of a clinical trial by a competent authority of a concerned Member States can be granted only if the concerned Ethics Committee has given its approval.
Amendment 322 #
Proposal for a regulation
Article 6 – paragraph 5 a (new)
Article 6 – paragraph 5 a (new)
5a. The assessment report shall be submitted through the EU portal to the EU database and made publicly available.
Amendment 355 #
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 461 #
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. Informed consent shall be written, dated and signed and given freely by the subject or his or her legal representative after having been ducomprehensively informed of the nature, duration, significance, implications and risks of the clinical trial. I, including whether the clinical trial has to be discontinued, the eventual treatment alternatives, and any other information, as provided for in national legislation. Information shall also be given orally with the opportunity to ask questions, and the subject shall be provided with comprehensive information in writing which he or she is allowed to keep. Adequate time shall be given to the subject to consider his or her decision. The information provided and the informed consent shall be appropriately documented. Where the subject is unable to write, oral consent in the presence of at least one impartial witness, trustful for the subject, may be given in exceptional cases. The subject or his or her legal representative shall be provided with a copy of the document by which informed consent has been given. The following information shall systematically be indicated on the document by which informed consent is given: a. The trial registration number in the EU portal, and b. A statement that the results will be made available in the EU portal within one year after completion of the trial, together with the indication of the approximate date.
Amendment 533 #
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 1
Article 34 – paragraph 3 – subparagraph 1
3. Within one year from the end of a clinical trial, the sponsor shall submit to the EU database a summary of the results of the clinical trialll results and all the supporting data of the clinical trial in the form of a complete clinical study report; the report shall be easily searchable.
Amendment 536 #
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 2
Article 34 – paragraph 3 – subparagraph 2
However, where, for justified scientific reasons, it is not possible to submit a summary of the results within one year, the summary of resultsthe full study report with all results and all the supporting data within one year, it shall be submitted as soon as it is available. In this case, the protocol shall specify when the results are going to be submitted, together with an explanationfull clinical study report with all results and all supporting data is going to be submitted, together with a justification. The justification shall be made publicly accessible in the EU database.
Amendment 542 #
Proposal for a regulation
Article 34 – paragraph 3 a (new)
Article 34 – paragraph 3 a (new)
3a. In case of non-compliance by the sponsor with the obligation referred to in paragraph 3, harmonised penalties shall be enforced by the concerned Member States. The amount shall be up to 7 000 EUR for the 30 first day of non- compliance and up to 7 000 EUR per each additional delay day until compliance.
Amendment 559 #
Proposal for a regulation
Article 38 – paragraph 3
Article 38 – paragraph 3
Amendment 597 #
Proposal for a regulation
Article 53 – paragraph 1
Article 53 – paragraph 1
1. All clinical trial information shall be recorded, processed, handled, and stored in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal data of the subjects remain protected in accordance with the applicable legislation on personal data protection with easily searchable clinical study reports being publicly available online.