8 Amendments of Marina YANNAKOUDAKIS related to 2012/0192(COD)
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 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 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 The information in the database should be public, unless specific reasons require that a piece of information should not be published, in order to protect the right of the individual to private life and the right to the protection of personal data, recognised by Articles 7 and 8 of the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 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 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.