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 The information in the database should be public, unless specific reasons require that a piece of information should not be published, in order to protect the right of the individual to private life and the right to the protection of personal data, recognised by Articles 7 and 8 of the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