5 Amendments of Eija-Riitta KORHOLA related to 2012/0192(COD)
Amendment 85 #
Proposal for a regulation
Recital 4
Recital 4
(4) Directive 2001/20/EC aimed to simplify and harmonise the administrative provisions governing clinical trials in the European Union. However, experience shows that a harmonised approach to the regulation of clinical trials has only been partly achieved. This makes it in particular difficult to perform a clinical trial in several Member States. Scientific development however, suggests that future clinical trials will target more specific patient populations, such as subgroups identified through genomic information. In order to include a sufficient number of patients for such trials it may be necessary to involve many, or all, Member States. The new procedures for the authorisation of clinical trials should stimulate the inclusion of as many member states as possible. Therefore, in order to simplify submission procedures, the multiple submission of largely identical information should be avoided and replaced by the submission of one application dossier through a single submission portal to all the Member States concerned. The portal should reduce unnecessary red tape so that not only sponsors and academic researchers carrying out multinational research but also public authorities may benefit from its use.
Amendment 180 #
Proposal for a regulation
Recital 66 a (new)
Recital 66 a (new)
(66 a) The regulation should be assessed and where necessary revised at five-year intervals in order to ensure its flexibility. A continuing assessment process is essential so that innovations can continue to be made in future in the context of constantly developing medical science. The administrative burden of the current directive is regarded as a constraint on science and on the right of patients to obtain the best possible care. The regulation’s impact in terms of red tape should therefore be monitored regularly and the assessment process should guarantee its effectiveness as legislation supporting clinical research. Particular attention should be paid to the position of academic research, and to ensuring that red tape does not divert resources from innovation in academic research and that the new tasks required by the regulation do not have a negative impact on the attractiveness of a research career. The importance of public access to information in making Europe attractive as a research environment and its effect on the balance between individual data protection, intellectual property, and contract, patent and intangible rights, should also be assessed. The assessment process should also look at the impact of the regulation on whether, in place of clinical trials, more experimental treatment is being carried out which has unpredictable effects on patient safety and the reliability of experimental results.
Amendment 457 #
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. Any subject may, without any resulting detriment, withdraw from the clinical trial at any time by revoking his or her informed consent. The withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal. As all clinical trial information, also the data collected before the withdrawal of the consent shall be recorded, handled and stored in such a way that they can be accurately reported, interpreted and verified while the confidentiality of the trial subjects remains protected.
Amendment 512 #
Proposal for a regulation
Article 32 – paragraph 1 – point e
Article 32 – paragraph 1 – point e
(e) the clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject, although this should be judged in proportion to the underlying medical condition.
Amendment 594 #
Proposal for a regulation
Article 52 – paragraph 3
Article 52 – paragraph 3
3. The investigator’s brochure shall be updated where newnever new and relevant safety information becomes available, and at least once per year.