51 Amendments of Anna ROSBACH related to 2012/0192(COD)
Amendment 76 #
Proposal for a regulation
Recital 1
Recital 1
(1) In a clinical trial the safety and, rights and health of subjects should be protected and the data generated should be reliable and robust.
Amendment 79 #
Proposal for a regulation
Recital 2
Recital 2
(2) In order to allow for independent control as to whether these principles are adhered to, a clinical trial should be subject to prior authorisation and it should be ensured that those granting the authorisation do not have conflicts of interest and are independent of the sponsor, the institution of the trial site and the investigators involved.
Amendment 80 #
Proposal for a regulation
Recital 2
Recital 2
(2) In order to allow for independent control as to whether these principles are adhered to, a clinical trial should be subject to prior authorisation, and approval by an ethics committee prior to commencement.
Amendment 121 #
Proposal for a regulation
Recital 21
Recital 21
(21) It should be left to Member States to establish the language requirements for the application dossier. To ensure that the assessment of the application for authorisation of a clinical trial functions smoothly, Member States should considerwork towards accepting a commonly understood language in the medical field as the language for the documentation not destined to the subject, such as the Patient Information and the Informed Consent Sheet.
Amendment 129 #
Proposal for a regulation
Recital 24
Recital 24
(24) In accordance with international guidelines, the free and informed consent of the subject should be in writing, save in exceptional situations. It should be based on information which is clear, relevant and understandable to the subject, and should be in the subject's own language.
Amendment 132 #
Proposal for a regulation
Recital 26
Recital 26
(26) In order for the sponsor to assess all potentially relevant safety information, the investigator should report to him all serious adverse events. and all suspected serious adverse events.
Amendment 134 #
Proposal for a regulation
Recital 28
Recital 28
(28) The Agency should as soon as possible forward this information to the Member States for them to assess this information.
Amendment 142 #
Proposal for a regulation
Recital 33
Recital 33
(33) During a clinical trial, a sponsor may become aware of serious breaches of the rules for the conduct of the clinical trial. This should be reported to the Member States concerned, as well as to the Agency, in order for action to be taken by those Member States, where necessary.
Amendment 176 #
Proposal for a regulation
Recital 64 a (new)
Recital 64 a (new)
(64a) As stated in the Commission Communication on "An Integrated Industrial Policy for the Globalisation Era-Putting Competitiveness and Sustainability at Centre Stage", systematic evaluations of legislation should become an integral part of smart regulation. To ensure that this Regulation keeps pace with scientific and technological progress with regard to the organization and conduct of clinical trials and that it interfaces with other legal provisions, the Commission should periodically report on the experience with and functioning of the Regulation, and present its conclusions thereof.
Amendment 205 #
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, or the placebos, are authorised;
Amendment 222 #
Proposal for a regulation
Article 2 – paragraph 2 – point 11 a (new)
Article 2 – paragraph 2 – point 11 a (new)
(11 a) 'Reporting Member State': the Member State coordinating and documenting the assessment of an application for authorisation or of a substantial modification, which involves three or more Member States, and which has been submitted under Chapters II and III of this Regulation.
Amendment 253 #
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 shall abide by all relevant international norms and standards. The Ethics Committee shall consist of a reasonable number of members, 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.
Amendment 260 #
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 StateMember States concerned shall determine which state shall be the reporting Member State according to an established procedure based on objective criteria which are set by the Commission.
Amendment 264 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Amendment 265 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Where the proposed reporting Member State does not wish to be the reporting Member State, it shall agree with another Member State concerned that the latter will be the reporting Member State. If no Member State concerned accepts to be the reporting Member State, the proposed reporting Member State shall be the reporting Member State, unless the proposed reporting Member State can justify that it does not have sufficient capacity to fulfil the task in a satisfactory manner.
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 307 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph -1 (new) and sub-paragraph 1 – introductory part
Article 6 – paragraph 4 – subparagraph -1 (new) and sub-paragraph 1 – introductory part
4. The assessment date shall, for the purposes of this Chapter, be the date on which the assessment report is submitted to the other Member States concerned and the reporting date shall be the date when the final assessment report is submitted to the sponsor and to the other Member States concerned. The reporting Member State shall submit Part I of the assessment report, including its conclusion, to the sponsor and to the other Member States concerned within the following time periods, which shall include periods for initial assessment, for joint assessment and for consolidation of the final report:
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 324 #
Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 2
Article 6 – paragraph 6 – subparagraph 2
For the purpose of obtaining those additional explanations, the reporting Member State may suspextend the time period referred to in paragraph 4 for a maximum of 120 days for low-intervention clinical trials and for a maximum of 230 days for trials other than low-intervention clinical trials.
Amendment 327 #
Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 3
Article 6 – paragraph 6 – subparagraph 3
Amendment 328 #
Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 5 a (new)
Article 6 – paragraph 6 – subparagraph 5 a (new)
The reporting Member State may also extend the time referred to in paragraphs 4 and 6 with a further 60 days for trials involving Advanced Therapy Medicinal Products or other novel therapies, for the purpose of consulting with expert committees.
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 370 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Member States shall ensure that the persons validating and assessing the application do not have conflicts of interest, are independent of the sponsor, the institution of the trial site and the investigators involved, as well as free of any other undue influence. Where possible, the persons validating the applications shall therefore publish in the EU database a declaration of their interests, or a statement that they have none.
Amendment 375 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Member States shall ensure that the assessment is done jointly by a reasonable number of persons, including a significant number of medical doctors, who collectively have the necessary qualifications and experience.
Amendment 377 #
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. In the assessment, the view of at least one person whose primary area of interest is non-scientific shall be taken into account. The view of at least one patient shall be taken into account. An independent Ethics Committee, as referred to in the Declaration of Helsinki and the ICH-GCP, shall be involved in the assessment of each clinical trial.
Amendment 396 #
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. TheWhere there was a reporting Member State for the application referred to in paragraph 1initial authorisation procedure, it shall be the reporting Member State for the initial authorisation procedureapplication referred to in paragraph 1.
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 507 #
Proposal for a regulation
Article 32 – paragraph 1 – point a
Article 32 – paragraph 1 – point a
(a) due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical condition, it is impossible to obtain prior informed consent from the subject or its legal representative (parent or guardian) and it is impossible to supply prior information to the subject or its legal representative (parent or guardian);
Amendment 509 #
Proposal for a regulation
Article 32 – paragraph 1 – point c
Article 32 – paragraph 1 – point c
(c) the subject or legal representative has not previously expressed objections known to the investigator;
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 532 #
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 and to the public EudraPharm database a summary of the results of the clinical trial.
Amendment 564 #
Proposal for a regulation
Article 39 – paragraph 1 a (new)
Article 39 – paragraph 1 a (new)
1a. Where the sponsor does not have access to certain information and, therefore, is not able to submit a complete report, this shall be stated in the report. In the case of a clinical trial involving the use of more than one investigational medicinal product, the sponsor may submit a single safety report on all investigational medicinal products used in the trial. The sponsor shall provide the reasons for this decision in the report.
Amendment 565 #
Proposal for a regulation
Article 39 – paragraph 2
Article 39 – paragraph 2
2. The obligation for a particular sponsor referred to in paragraph 1 starts with the first authorisation of a clinical trial in accordance with this Regulation for that sponsor. It ends with the end of the last clinical trial conducted by the sponsor with the investigational medicinal product. The annual reporting obligation shall not apply when a sponsor is not currently conducting any clinical trials with the investigational medicinal product.
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.