29 Amendments of Christel SCHALDEMOSE related to 2012/0192(COD)
Amendment 33 #
Proposal for a regulation
Recital 1
Recital 1
(1) In a clinical trial the safety and rights of subjects should be protected and the data generated should be reliable and robust, robust and reflect the diversity of the population in terms of age and gender balance.
Amendment 34 #
Proposal for a regulation
Recital 9
Recital 9
(9) The risk to subject safety in a clinical trial mainly stems from two sources: the investigational medicinal product and the intervention. Many clinical trials, however, pose only a minimal additional risk to subject safety compared to normal clinical practice. This is in particular the case where the investigational medicinal product is covered by a marketing authorisation (i.e. the quality, safety and efficacy has already been assessed in the course of the marketing authorisation procedure) and where the intervention poses only very limited additional risk to the subject compared to normal clinical practicethe best current proven intervention. Those ‘"low- intervention clinical trials’" are often of crucial importance to assess standard treatments and diagnoses, thereby optimising the use of medicinal products and thus contributing to a high level of public health. They should be subject to less stringent rules, such as shorter deadlines for approval.
Amendment 40 #
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14a) The Commission shall issue guidelines in consultation with Member States, academia and civil society organisations to specify the content and format of the results of the clinical trial.
Amendment 42 #
Proposal for a regulation
Recital 16
Recital 16
(16) The sponsor should be allowed to withdraw the application for authorisation of a clinical trial. To ensure the reliable functioning of the assessment procedure, however, an application for authorisation of a clinical trial should be withdrawn only for the entire clinical trial. It should be possible for the sponsor to submit a new application for authorisation of a clinical trial following the withdrawal of an application, provided that the new application contains explanations regarding any previous withdrawals.
Amendment 43 #
Proposal for a regulation
Recital 20
Recital 20
(20) In order to increase transparency in the area of clinical trials, clinical trial data submitted in support of a clinical trial application should be based only on clinical trials recorded in a publicly accessiblnd easily accessible database without imposing any cost on the access to the database.
Amendment 51 #
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37a) The Commission should within two years after the adoption of this Regulation submit the European Parliament with an evaluation of the management of raw data and the feasibility of introducing open access for independent scientists to raw data.
Amendment 52 #
Proposal for a regulation
Recital 46
Recital 46
(46) In clinical trials with non-authorised investigational medicinal products, or where the intervention poses more than an insignificant risk to subject safety, compensation should be ensured for damages successfully claimed in accordance with the applicable laws.
Amendment 54 #
Proposal for a regulation
Recital 51
Recital 51
(51) In order to streamline and facilitate the flow of information between sponsors and Member States as well as between Member States, the Commission should set up and maintain a database, accessed through a portal. The Commission and Member States should raise awareness among the general public on the existence of the portal.
Amendment 75 #
Proposal for a regulation
Article 2 – paragraph 2 – point 13
Article 2 – paragraph 2 – point 13
(13) ‘'Sponsor’': an individual, company, institution or organisation which takes responsibility for the initiation and, the management or the funding of the clinical trial;
Amendment 77 #
Proposal for a regulation
Recital 1
Recital 1
(1) In a clinical trial the safety and rights of subjects should be protected and the data generated should be reliable and robust, robust and reflect the diversity of the population in terms of age and gender balance.
Amendment 86 #
Proposal for a regulation
Article 3 – paragraph 1 – indent 2 a (new)
Article 3 – paragraph 1 – indent 2 a (new)
- it responds to therapeutic and public health needs;
Amendment 97 #
Proposal for a regulation
Recital 9
Recital 9
(9) The risk to subject safety in a clinical trial mainly stems from two sources: the investigational medicinal product and the intervention. Many clinical trials, however, pose only a minimal additional risk to subject safety compared to normal clinical practice. This is in particular the case where the investigational medicinal product is covered by a marketing authorisation (i.e. the quality, safety and efficacy has already been assessed in the course of the marketing authorisation procedure) and where the intervention poses only very limited additional risk to the subject compared to normal clinical practicethe best current proven intervention. Those ‘low- intervention clinical trials’ are often of crucial importance to assess standard treatments and diagnoses, thereby optimising the use of medicinal products and thus contributing to a high level of public health. They should be subject to less stringent rules, such as shorter deadlines for approval.
Amendment 103 #
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, reflecting the population groups to be treated. taking account of statistical approaches, design of the trial and methodology (including sample size and randomisation, comparator and endpoints);
Amendment 129 #
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 reasons for the disagreement must be published through the EU portal.
Amendment 136 #
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
The sponsor may withdraw the application at any time until the assessment date. In such a case, the application may only be withdrawn with respect to all Member States concerned. The reasons for the withdrawal must be communicated to all Member States concerned and published through the portal mentioned in this Regulation.
Amendment 138 #
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
This Chapter is without prejudice to the possibility for the sponsor to submit, following the refusal to grant an authorisation or the withdrawal of an application, an application for authorisation to any intended Member State concerned. That application shall be considered as a new application for authorisation of another clinical trial. Explanations about previous applications, withdrawals and refusals must be included in the new application.
Amendment 143 #
Proposal for a regulation
Article 25 – paragraph 5
Article 25 – paragraph 5
5. Where the clinical trial has been conducted outside the Union, it shall comply with principles equivalent to thosethe provisions of this Regulation as regards subject rights and, safety and, health and the relevance, reliability and robustness of data generated in the clinical trial.
Amendment 150 #
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37a) Within two years after the adoption of this Regulation, the Commission should submit the European Parliament an evaluation of the management of raw data, and the feasibility of introducing an open access for independent scientists to raw data from all clinical trials.
Amendment 164 #
Proposal for a regulation
Recital 51
Recital 51
(51) In order to streamline and facilitate the flow of information between sponsors and Member States as well as between Member States, the Commission should set up and maintain a database, accessed through a portal. The Commission and the Member States should raise awareness among the general public about the existence of this portal.
Amendment 168 #
Proposal for a regulation
Article 33 – paragraph 2 a (new)
Article 33 – paragraph 2 a (new)
2a. Prior to the start, all clinical trials should be registered in the database mentioned in this Regulation. Information provided shall include the start and the end date of the recruitments of subjects.
Amendment 174 #
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 2
Article 34 – paragraph 3 – subparagraph 2
Amendment 185 #
Proposal for a regulation
Article 49 – paragraph 2
Article 49 – paragraph 2
2. For the purposes of this Article, a ‘'serious breach’' means a breach likely to affect to a significant degree the safety and, rights and health of the subjects or the reliability and robustness of the data generated in the clinical trial.
Amendment 187 #
Proposal for a regulation
Article 55 – paragraph 1
Article 55 – paragraph 1
Amendment 189 #
Proposal for a regulation
Article 72 – paragraph 1
Article 72 – paragraph 1
For clinical trials other than low- intervention clinical trials, the sponsor shall ensure that compensation in accordance with the applicable laws on liability of the sponsor and the investigator is provided for any damage suffered by the subject. This damage compensation shall be provided independently of the financial capacity of the sponsor and the investigator.
Amendment 193 #
Proposal for a regulation
Article 74 – paragraph 2
Article 74 – paragraph 2
2. The measures referred to in paragraph 1 shall be made publicly available on and communicated to all Member States concerned through the EU portal.
Amendment 201 #
Proposal for a regulation
Annex I – part 16 – point 61
Annex I – part 16 – point 61
61. Description of any agreement between the sponsor and the site shall be submitted and made publicly available.
Amendment 247 #
Proposal for a regulation
Article 3 – paragraph 1 – indent 2 a (new)
Article 3 – paragraph 1 – indent 2 a (new)
- the trial responds to therapeutic and public health needs;
Amendment 522 #
Proposal for a regulation
Article 33 – paragraph 2 a (new)
Article 33 – paragraph 2 a (new)
2a. Prior to the start, all clinical trials shall be registered in the database mentioned in this Regulation. Information provided shall include the start date and the end date of the recruitments of subjects.
Amendment 601 #
Proposal for a regulation
Article 55 – paragraph 1
Article 55 – paragraph 1