29 Amendments of Dagmar ROTH-BEHRENDT related to 2012/0192(COD)
Amendment 165 #
Proposal for a regulation
Recital 51
Recital 51
(51) In order to streamline and facilitate the flow of information between sponsors and Member States as well as between Member States, the European Medicines Agency, on behalf of the Commission, should set up and maintain a database, accessed through a portal.
Amendment 252 #
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Article 4 a Ethics Committee 1. Authorisation of a clinical trial shall not be granted before an independent ethics committee has made a positive decision on the clinical trial. The Ethics Committee assessment shall include, in particular, the compliance with the requirements specified in Chapter V, Article 46, Article 47 and Chapter XII. 2. The Ethics Committee shall ensure that the rights, safety and well-being of subjects are protected. It shall be independent of the researcher, independent of the sponsor, and free of any other undue influence. It shall act in accordance with the laws and regulations of the country or countries in which the research is to be conducted and must abide by all relevant international norms and standards. The Ethics Committee shall consist of a clearly defined number of members and substitutes which include healthcare professionals, laypersons and at least one well-experienced, knowledgeable patient or patient representative, who collectively possess the relevant qualifications and experience to be able to review and evaluate the scientific, medical and ethical aspects of the proposed trial. 3. Member States shall take the necessary measures to establish Ethics Committees and facilitate their work. Members States shall publish the number, the names and the profession of the members and substitutes of the Ethics Committee and inform the European Commission about the composition of the Ethics Committee and its start of work.
Amendment 259 #
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 Statereporting Member State shall be chosen among those five Member States concerned where most of the subjects participating in the clinical trial in question live. This decision shall be taken in line with a procedure which the Commission shall develop, establish and control. The decision procedure shall ensure that the chosen reporting Member State has the capacities and scientific infrastructure to assess the possible clinical trial in question.
Amendment 264 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Amendment 269 #
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. Within six14 days following submission of the application dossier, the proposed reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 276 #
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 214 days, 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 280 #
Proposal for a regulation
Article 5 – paragraph 4 – subparagraph 3
Article 5 – paragraph 4 – subparagraph 3
Where the proposed reporting Member State has not notified the sponsor according to points (a) to (d) of paragraph 2 within threeseven days following receipt of the comments or of the completed application, the application shall be considered complete, the clinical trial shall be considered as falling within the scope of this Regulation, the clinical trial shall be considered as 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 310 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point a
Article 6 – paragraph 4 – subparagraph 1 – point a
(a) within 10 days from the validation date25 days, but no earlier than 15 days after receipt of the successfully validated application, for low-intervention clinical trials;
Amendment 313 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point b
Article 6 – paragraph 4 – subparagraph 1 – point b
(b) within 25 days from the validation date35 days but no earlier than 20 days after receipt of the successfully validated application for clinical trials other than low- intervention clinical trials;
Amendment 317 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point c
Article 6 – paragraph 4 – subparagraph 1 – point c
(c) within 30 days from the validation date40 days but no earlier than 30 days after receipt of the successfully validated application for any clinical trial with an advanced therapy investigational medicinal product.
Amendment 321 #
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Until the assessment date, any Member State concerned may communicate to the reporting Member State any considerations relevant to the application. The reporting Member State shall take those considerations duly into account and shall document them in the assessment report. If the assessment report of the reporting Member State deviates from the considerations of the Member States concerned, it shall state the reasons for this deviation in the assessment report.
Amendment 359 #
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 3 a (new)
Article 8 – paragraph 2 – subparagraph 3 a (new)
Notwithstanding the first and second subparagraphs, in case of other conflict, the Member States involved shall attempt to agree on a conclusion. If no conclusion is found, the Commission shall take a decision on the conclusion after having heard the Member States involved, and, if appropriate, having taken advice from the European Medicines Agency.
Amendment 409 #
Proposal for a regulation
Article 15
Article 15
A substantial modification may only be implemented if it has been approved in accordance with the procedure set out in this Chapter, and if it has been approved by an independent ethics committee before its implementation.
Amendment 412 #
Proposal for a regulation
Article 17 – paragraph 2 – introductory part
Article 17 – paragraph 2 – introductory part
2. Within fourten days following submission of the application dossier, the reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 425 #
Proposal for a regulation
Article 20 – paragraph 5 – subparagraph 2
Article 20 – paragraph 5 – subparagraph 2
Notification shall be done by way of one single decision within ten days from the validation dateassessment date according to Article 6 (4).
Amendment 454 #
Proposal for a regulation
Article 28 – paragraph 1 – point d
Article 28 – paragraph 1 – point d
(d) the subject or, where the subject is not able to give informed consent, his or her legal representative has had the opportunity, in a prior interview with a medical doctor who is the investigator or a member of the investigating team, to understand the objectives, risks and inconveniences of the clinical trial, and the conditions under which it is to be conducted and has also been informed of the right to withdraw from the clinical trial at any time without any resulting detriment;
Amendment 460 #
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. Any subject or his legal representative may, without any resulting detriment, withdraw from the clinical trial at any time by revoking his or her informed consent. The withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal.
Amendment 463 #
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 and comprehensibly informed of the nature, significance, implications and risks of the clinical trial, and after having received the corresponding information in writing. It shall be appropriately documented. Where the subject is unable to write, oral consent in the presence of at least one impartial witness 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.
Amendment 474 #
Proposal for a regulation
Article 30 – paragraph 1 – point a
Article 30 – paragraph 1 – point a
(a) the informed consent of the legal representative has been obtained, whereby; consent shall represent the subject's presumed will and may be revoked at any time, without detriment to the subject;
Amendment 478 #
Proposal for a regulation
Article 30 – paragraph 1 – point c
Article 30 – paragraph 1 – point c
(c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time is consideredduly taken into account by the investigator;
Amendment 481 #
Proposal for a regulation
Article 30 – paragraph 1 – point h a (new)
Article 30 – paragraph 1 – point h a (new)
(ha) the Ethics Committee, with expertise in the relevant disease and the patient population concerned, or after taking advice in clinical, ethical and psychosocial questions in the field of the relevant disease and patient population concerned, has endorsed the protocol;
Amendment 487 #
Proposal for a regulation
Article 31 – paragraph 1 – point b
Article 31 – paragraph 1 – point b
(b) the minor has received all relevant information in a way adapted to his or her age and maturity, from professionalsa medical doctor (either the investigator or member of the trial team) trained or experienced in working with children, regarding the trial, the risks and the benefits;
Amendment 491 #
Proposal for a regulation
Article 31 – paragraph 1 – point c
Article 31 – paragraph 1 – point c
(c) the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time, is duly taken into consideration by the investigator in accordance with his or her age and maturity;
Amendment 496 #
Proposal for a regulation
Article 31 – paragraph 1 – point h b (new)
Article 31 – paragraph 1 – point h b (new)
(hb) the corresponding scientific guidelines of the Agency have been followed;
Amendment 498 #
Proposal for a regulation
Article 31 – paragraph 1 – point h d (new)
Article 31 – paragraph 1 – point h d (new)
(hd) the Ethics Committee, with paediatric expertise or after taking advice in clinical, ethical and psychosocial problems in the field of paediatrics, has endorsed the protocol;
Amendment 513 #
Proposal for a regulation
Article 32 – paragraph 1 – point e
Article 32 – paragraph 1 – point e
(e) the Ethics committee positively assesses that a direct benefit of the clinicial trial for the patient is to be expected, as well as the fact that the clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject.
Amendment 570 #
Proposal for a regulation
Article 40 – paragraph 2 a (new)
Article 40 – paragraph 2 a (new)
2 a. The responsible Ethics Committee shall be involved in the assessment of this information.
Amendment 605 #
Proposal for a regulation
Article 58 – paragraph 5 – point a
Article 58 – paragraph 5 – point a
(a) labelling, re-labelling, packaging, re- packaging or reconstitution prior to use or packaging, where those processes are carried out in hospitals, health centres or clinics, by pharmacists or other persons legally authorised in the Member State to carry out such processes, and if the investigational medicinal products are intended to be used exclusively by those institutions;
Amendment 606 #
Proposal for a regulation
Article 58 – paragraph 5 – point c
Article 58 – paragraph 5 – point c
(c) the preparation of medicinal products referred to in Article 3(1) and (2) of Directive 2001/83/EC or in accordance with the study plan provided by the sponsor.