Activities of Kent JOHANSSON 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 (9)
Amendment 44 #
Proposal for a regulation
Recital 6
Recital 6
(6) The Member States concerned should cooperate in assessing a request for authorisation of a clinical trial. This cooperation should not include aspects of an intrinsically national nature, nor ethical aspects of a clinical trial, such as informed consent.
Amendment 48 #
Proposal for a regulation
Recital 12
Recital 12
(12) Some aspects in a clinical trial application relate to issues of an intrinsic national nature or to ethical aspects of a clinical trial. Those issues should not be assessAlthough Member States' cooperation should be encouraged, in cooperation among all Member Statt should be limited to exchange of views and best practices concerned these matters.
Amendment 76 #
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 withor if another Member State concerned that the latter will be theis willing to be reporting Member State, the appointment of the reporting Member State shall be a joint decision between the proposed reporting Member State. If no and the Member States concerned accepts to be the reportingthrough a vote at the EU portal. The reporting Member State shall be appointed within four days. If no alternative reporting Member State receives a majority of the given votes, or if the trial only involves one Member State, the proposed reporting Member State shall be the reporting Member State.
Amendment 78 #
Proposal for a regulation
Article 5 – paragraph 2 – point a
Article 5 – paragraph 2 – point a
(a) whether it is the reporting Member State or which otherich Member State concerned is the reporting Member State;
Amendment 81 #
Proposal for a regulation
Article 5 – paragraph 4 – subparagraph 1
Article 5 – paragraph 4 – subparagraph 1
Where the proposed reporting Member State finds that the application is not complete, that the clinical trial applied for does not fall within the scope of this Regulation, or that the clinical trial is not a low-intervention clinical trial while this is claimed by the sponsor, it shall inform the sponsor thereof through the EU portal and shall set a maximum of six days for the sponsor to comment or to complete the application through the EU portal. The reporting Member State may not infer ethical concerns as a justification for considering the application not complete or not falling within the scope of this Regulation.
Amendment 108 #
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 on 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, through the EU portal to the Commission, to all Member States, and to the sponsor. The Member State concerned may not infer ethical concerns as a justification.
Amendment 142 #
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 interruption of a trial, the sponsor shall submit to the EU database a summary of the results of the clinical trial. n exhaustive summary of both the positive and negative results of the clinical trial. This exhaustive summary shall in a clear and unambiguous way describe the methods and conducts of the study, and include baseline data as well as anonymised patient data.
Amendment 159 #
Proposal for a regulation
Article 78 – paragraph 3 – introductory part
Article 78 – paragraph 3 – introductory part
3. The EU database shall be publicly accessible in accordance with the provisions of Regulation (EC) 1049/2001 unless, for all or parts of the data and information contained therein, confidentiality is justified on any of the following grounds:
Amendment 162 #
Proposal for a regulation
Article 78 – paragraph 3 a (new)
Article 78 – paragraph 3 a (new)
3a. The definition of what is considered as commercial confidential shall be in accordance with EMA guidelines and shall not be allowed to override the interest of public health research.