Activities of Alda SOUSA related to 2012/0192(COD)
Plenary speeches (1)
Clinical trials on medicinal products for human use (debate)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC PDF (1 MB) DOC (2 MB)
Amendments (42)
Amendment 70 #
Proposal for a regulation
Article 3 – paragraph 1 – indent 1 a (new)
Article 3 – paragraph 1 – indent 1 a (new)
- the evaluation of the ethical acceptability of the clinical trial is positive;
Amendment 83 #
Proposal for a regulation
Article 5 – paragraph 5 a (new)
Article 5 – paragraph 5 a (new)
5a. The assessment report shall be submitted through the EU portal and made publicly available.
Amendment 127 #
Proposal for a regulation
Recital 23
Recital 23
(23) This Regulation should provide for clear rules concerning informed consent in emergency situations. Such situations relate to cases where for example a patient has suffered a sudden life-threatening medical condition due to multiple traumas, strokes or heart attacks, necessitating immediate medical intervention. For such cases, intervention within an ongoing clinical trial, which has already been approved, may be pertinent. However, in certain circumstances, due to the unconsciousness of the patient and the absence of an immediately available legal representative, it is not possible to obtain informed consent prior to the intervention. The Regulation should therefore set clear rules whereby such patients may be enrolled in the clinical trial under very strict conditions. In addition, the said clinical trial should relate directly to the medical condition which causes the impossibility of the patient to give informed consent. Any previously expressed objection by the patient must be respected, and informed consent from the subject or the legal representative should be sought as soon as possible. An ethics committee should positively assess the direct benefit of the clinical trial to the patient, as well as the fact that the clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject;
Amendment 134 #
Proposal for a regulation
Article 27a (new)
Article 27a (new)
Amendment 144 #
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 1
Article 34 – paragraph 3 – subparagraph 1
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 trial, whether the results are positive or negative or inconclusive.
Amendment 149 #
Proposal for a regulation
Recital 37
Recital 37
(37) The information generated in the clinical trial should be recorded, handled and stored adequately for the purpose of ensuring subject rights and, safety, and well- being, and the robustness and reliability of the data generated in the clinical trial, accurate reporting and interpretation, effective monitoring by the sponsor and effective inspection by Member States or the Commission.
Amendment 179 #
Proposal for a regulation
Recital 66
Recital 66
(66) Since the objective of this Regulation, namely to ensure that, throughout the Union, clinical trial data are reliable and robust while ensuring the safety, well- being and rights of subjects, cannot sufficiently be achieved by the Member States and can, by reason of the scale of the measure, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,
Amendment 187 #
Proposal for a regulation
Article 2 – paragraph 2 – point 2 – point a
Article 2 – paragraph 2 – point 2 – point a
(a) the investigational medicinal products are not authorised in any Member State;
Amendment 224 #
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 which is made after notification of the decision referred to in Articles 8, 14, 19, 20 and 23 and which is likely to have a substantial impact on the safety or, rights or well-being of the subjects or on the reliability and robustness of the data generated in the clinical trial;
Amendment 243 #
Proposal for a regulation
Article 3 – paragraph 1 – indent 1
Article 3 – paragraph 1 – indent 1
– the rights, safety, dignity and well-being of subjects are protected; and
Amendment 245 #
Proposal for a regulation
Article 3 – paragraph 1 – indent 1 a (new)
Article 3 – paragraph 1 – indent 1 a (new)
- the evaluation of the ethical acceptability of the clinical trial is positive;
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 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 286 #
Proposal for a regulation
Article 5 – paragraph 5 a (new)
Article 5 – paragraph 5 a (new)
5 a. The assessment report shall be submitted through the EU portal and made publicly available.
Amendment 305 #
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The reporting Member State shall draw up an assessment report. Simultaneously the concerned Member States shall assess the ethical aspects of paragraph 1. The assessment of the aspects referred to in paragraph 1 shall constitute Part I of the assessment report, which shall include the assessment of the ethical aspects provided by the Member States involved in the procedure.
Amendment 308 #
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – introductory part
Article 6 – paragraph 4 – subparagraph 1 – introductory part
4. 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, within which the concerned Member States shall also be obliged to submit their comments on the ethical aspects to the parties involved:
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 333 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point a
Article 7 – paragraph 1 – subparagraph 1 – point a
(a) compliance with the requirements for the protection of the subjects and informed consent as set out in Chapter V;
Amendment 354 #
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) well-founded ethical concerns that emerge from the assessment in Article 6, paragraph 1;
Amendment 356 #
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 thereof,reporting Member State, it shall communicate its disagreement through the EU portal to the Commission, to all Member States, and to the sponsor.
Amendment 385 #
Proposal for a regulation
Article 10 – paragraph 3 a (new)
Article 10 – paragraph 3 a (new)
3a. Where national provisions on the protection of clinical trial subjects are more comprehensive than the provisions of this Regulation, the most protective measures shall apply.
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 447 #
Proposal for a regulation
Article 27 a (new)
Article 27 a (new)
Article 27a Public access to clinical study reports Free and easy access to clinical data held in the Agency's database and particularly to clinical study reports shall be granted to the public. To this end, an hyperlink shall be included to the clinical study reports of the clinical trials.
Amendment 451 #
Proposal for a regulation
Article 28 – paragraph 1 – point c
Article 28 – paragraph 1 – point c
(c) the subject or, where the subject is not able to give informed consent, his or her legal representative has given informed consent. Any person asked to participate in a clinical trial shall have the right to refuse such participation without any resulting liability or detriment;
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 464 #
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 duly informed of the nature, significance, implications and risks of the clinical trial. 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 and the identity of this impartial witness shall be registered. 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 467 #
Proposal for a regulation
Article 29 – paragraph 2
Article 29 – paragraph 2
2. Written information shall be given to the subject and/or the legal representative fprior the purposes ofo the obtaining of his or her informed consent. It shall be kept concise, clear, relevant, and understandable to a lay person. It shall include both medical and legal information. It shall inform the subject about his or her right to revoke his or her informed consent at any time of the clinical trial.
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 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 528 #
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 trial, whether the results are positive or negative and inconclusive.
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.