Activities of Françoise GROSSETÊTE related to 2012/0192(COD)
Shadow opinions (1)
OPINION 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
Amendments (25)
Amendment 47 #
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) In case of an urgent situation as well as for rare and ultra-rare diseases which are life-threatening and for which therapeutic options and expertise are limited and geographically spread across the world, Member States should have the possibility to assess and authorise clinical trial applications in priority.
Amendment 49 #
Proposal for a regulation
Recital 22 a (new)
Recital 22 a (new)
(22a) Whereas most clinical trials are implemented for the assessment of therapies consisting of large samples of patient populations, the present Regulation should not discriminate patients suffering from rare and ultra- rare diseases and should integrate the specificities of low-prevalence conditions when assessing a trial.
Amendment 53 #
Proposal for a regulation
Recital 52
Recital 52
(52) The database should contain all relevant information as regards the clinical trial. No personal data of data subjects participating in a clinical trial should be recorded in the database and allow public dissemination of objective information in order to support European research and to increase knowledge in the field of public health. It should not undermine innovation or competitiveness of European industries. No personal data of data subjects participating in a clinical trial should be recorded in the database, and it should not hamper the protection of commercial interests, including intellectual property, as foreseen by Article 4 of Regulation 1049/2001. The information in the database should be public, unless specific reasons require that a piece of information should not be published, in order to protect the right of the individual to private life and the right to the protection of personal data, recognised by Articles 7 and 8 of the Charter of Fundamental Rights of the European Union, or commercially confidential information, as foreseen by Article 4 of Regulation 1049/2001..
Amendment 54 #
Proposal for a regulation
Recital 52 a (new)
Recital 52 a (new)
(52a) Commercially confidential information should be identified and protected in order to avoid harming the interests of patients and/or the competitive position of the sponsors.
Amendment 85 #
Proposal for a regulation
Article 6 – paragraph 1 – point a – point i – indent 3
Article 6 – paragraph 1 – point a – point i – indent 3
– the reliability and robustness of the data generated in the clinical trial, taking account of statistical approaches, design of the trial and, methodology (including sample size and randomisation, comparator and endpoints); and the prevalence of the condition, especially for rare diseases (which affect no more than five persons per 10 000), and ultra-rare diseases (which meet a prevalence threshold of no more than one affected person per 50 000).
Amendment 87 #
Proposal for a regulation
Article 6 – paragraph 1 – point a – point ii – indent 4 a (new)
Article 6 – paragraph 1 – point a – point ii – indent 4 a (new)
- the life-threatening and debilitating effects of certain diseases, such as some rare and ultra-rare diseases for which there are limited existing treatment options
Amendment 101 #
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) In case of an urgent situation as well as for rare and ultra-rare diseases which are life-threatening and for which therapeutic options and expertise are limited and geographically spread across the world, Member-States should have the possibility to assess and authorise clinical trial applications in priority.
Amendment 105 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point a a (new)
Article 7 – paragraph 1 – subparagraph 1 – point a a (new)
(aa) compliance with national legislative provisions related to ethics.
Amendment 116 #
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) Whereas most clinical trials are conducted for the assessment of therapies, targeted at large patient populations, and involving a large sample of patient populations, the present regulation should not discriminate against patients suffering from rare and ultra-rare diseases, and should integrate the specificities of low- prevalence conditions into the assessment of a trial.
Amendment 141 #
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 or discontinuation of development of a medicinal product, the sponsor shall submit to the EU database a summary of the positive and/or negative results of the clinical trial, as laid down in Annex IIIa. Until the publication of the summary of the results in accordance with the provisions of this paragraph, it shall only be accessible to the competent authorities of the Member States concerned.
Amendment 146 #
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 2 a (new)
Article 34 – paragraph 3 – subparagraph 2 a (new)
In order to protect personal data and commercially confidential information and subject to the provisions of Article 78(3), the summary of the results of a clinical trial intended to obtain a marketing authorisation shall be made public 30 days after the date of the marketing authorisation or 1 year after the end of the clinical trial in case of the discontinuation of the product development.
Amendment 148 #
Proposal for a regulation
Article 34 – paragraph 5 a (new)
Article 34 – paragraph 5 a (new)
5a. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 in order to amend Annex IIIa with the objective to adapt them to scientific or global regulatory developments.
Amendment 158 #
Proposal for a regulation
Article 78 – paragraph 2
Article 78 – paragraph 2
2. The EU database shall be established to enable the co-operation between the competent authorities of the Member States to the extent that it is necessary for the application of this Regulation and to search for specific clinical trials. It shall also enable sponsors to refer to previous submissions of an application for authorisation of a clinical trial or a substantial modification. Publicly available information contained in the database shall contribute to protecting public health and fostering the innovation capacity of European medical research, while recognising the legitimate economic interests of sponsors.
Amendment 161 #
Proposal for a regulation
Article 78 – paragraph 3 – indent 2
Article 78 – paragraph 3 – indent 2
– protecting commercially confidential information; specifically when related to clinical trials intended for the support of any marketing authorisation application for indications which have not yet been approved;
Amendment 163 #
Proposal for a regulation
Article 78 – paragraph 5
Article 78 – paragraph 5
5. No personal data of subjects, commercially confidential information or information undermining intellectual property rights shall be publicly accessible.
Amendment 165 #
Proposal for a regulation
Annex 1 – part 2 – point 6 – point 6 a (new)
Annex 1 – part 2 – point 6 – point 6 a (new)
whether the clinical trial significantly contributes to bringing a greater understanding of the physiology and pathology of a condition for which data is lacking, specifically for rare and ultra- rare diseases.
Amendment 166 #
Proposal for a regulation
Recital 52
Recital 52
(52) The database should contain all relevant information as regards the clinical trial. No personal data of data subjects participating in a clinical trial should be recorded in the database and allow public dissemination of objective information in order to support European research and to increase knowledge in the field of public health. It should not undermine innovation or competitiveness of European industries. No personal data of data subjects participating in a clinical trial should be recorded in the database, and it should not hamper the protection of commercial interests, including intellectual property, as provided for by Article 4 of Regulation 1049/2001. The information in the database should be public, unless specific reasons require that a piece of information should not be published, in order to protect the right of the individual to private life and the right to the protection of personal data, recognised by Articles 7 and 8 of the Charter of Fundamental Rights of the European Union, or commercially confidential information, as foreseen by Article 4 of Regulation 1049/2001.
Amendment 168 #
Proposal for a regulation
Annex 3 a (new)
Annex 3 a (new)
Amendment 169 #
Proposal for a regulation
Recital 52 a (new)
Recital 52 a (new)
Amendment 293 #
Proposal for a regulation
Article 6 – paragraph 1 – point a – point i – indent 3
Article 6 – paragraph 1 – point a – point i – indent 3
– the reliability and robustness of the data generated in the clinical trial, taking account of statistical approaches, design of the trial and, methodology (including sample size and randomisation, comparator and endpoints); and the prevalence of the condition, especially for rare diseases (which affect no more than five persons per 10 000), and ultra-rare diseases (which meet a prevalence threshold of no more than one affected person per 50 000).
Amendment 300 #
Proposal for a regulation
Article 6 – paragraph 1 – point a – point ii – indent 4 a (new)
Article 6 – paragraph 1 – point a – point ii – indent 4 a (new)
- the life-threatening and debilitating effects of certain diseases, such as some rare and ultra-rare diseases for which there are limited existing treatment options;
Amendment 335 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point a a (new)
Article 7 – paragraph 1 – subparagraph 1 – point a a (new)
(a a) compliance with national legislative provisions related to ethics;
Amendment 529 #
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 or discontinuation of the development of a medicinal product, the sponsor shall submit to the EU database a summary of the positive and/or negative results of the clinical trial, as laid down in Annex IIIa. Until the publication of the summary of the results in accordance with the provisions of this paragraph, it shall only be accessible to the competent authorities of the Member States concerned.
Amendment 539 #
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 2 a (new)
Article 34 – paragraph 3 – subparagraph 2 a (new)
In order to protect personal data and commercially confidential information, and subject to the provisions of Article 78(3), the summary of the results of a clinical trial intended to obtain a marketing authorisation shall be made public 30 days after the date of the marketing authorisation, or one year after the end of the clinical trial in case of the discontinuation of the product development.
Amendment 545 #
Proposal for a regulation
Article 34 – paragraph 5 a (new)
Article 34 – paragraph 5 a (new)
5 a. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 in order to amend Annex IIIa with the objective to adapt them to scientific or global regulatory developments.