19 Amendments of Petru Constantin LUHAN related to 2012/0192(COD)
Amendment 19 #
Proposal for a regulation
Article 36 a (new)
Article 36 a (new)
Article 36a Personal data of patients shall be processed in the database described above in a manner that it shall not permit the direct identification of the patient (without patients name or address). However, persons who need to know to identity patient for the purposes of protecting his or her vital interest shall have the possibility to do so (via an appropriate key).
Amendment 20 #
Proposal for a regulation
Article 41 – paragraph 1 a (new)
Article 41 – paragraph 1 a (new)
1a. Personal data processed in the electronic database set up by the Agency shall be stored as long as any of the active substances of any of the IMPs tested is in development or on the market within EU.
Amendment 22 #
Proposal for a regulation
Article 78 – paragraph 4 a (new)
Article 78 – paragraph 4 a (new)
4a. EU database shall not contain any personal data of trial participants.
Amendment 23 #
Proposal for a regulation
Article 78 – paragraph 7 a (new)
Article 78 – paragraph 7 a (new)
7a. Personal data of subjects processed in the EU database shall be stored for a maximum period of 5 year after the end of a clinical trial. Upon expiry of this period any question relative to the clinical trial shall be addressed to the general contact provided by the sponsor.
Amendment 81 #
Proposal for a regulation
Recital 2
Recital 2
(2) In order to allow for independent control as to whether these principles are adhered to, a clinical trial should be subject to prior authorisation which should include review by an Ethics Committee.
Amendment 112 #
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
(10a) Experience with Directive 2001/20/EC has also shown that 60% of clinical trials are sponsored by the pharmaceutical industry and 40% by other stakeholders, such as academics. The value of academic contribution should be duly recognized by member states. Academic sponsors frequently rely on funding which partly or entirely comes from the public funds or charities. In order to maximize the use of this valuable contribution and to further stimulate academic research but without any discrimination towards the quality of trials, measures should be put in place by member states to make appropriate exemptions from fees (application fees, inspection fees etc...) for trials conducted by academic sponsors.
Amendment 167 #
Proposal for a regulation
Recital 52
Recital 52
(52) The database should contain all relevant information as regards the clinical trial. All clinical trials should be registered in the database prior to being started. The start and end dates of the recruitment of subjects should also be published in the database. It should be possible for sponsors to enter this information directly into the database without the need to further notify Member States. No personal data of data subjects participating in a clinical trial should be recorded in the database. 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.
Amendment 196 #
Proposal for a regulation
Article 2 – paragraph 2 – point 2 – point e
Article 2 – paragraph 2 – point 2 – point e
(e) diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects, unless the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in any Member State concerned.
Amendment 251 #
Proposal for a regulation
Article 4 – paragraph 1 – sub-paragraphs 1 a and 1 b (new)
Article 4 – paragraph 1 – sub-paragraphs 1 a and 1 b (new)
Without prejudice to Article 87 and the contractual aspects which may need to be considered separately, the authorisation as mentioned in this chapter shall be sufficient to start a clinical trial in the Member States concerned. For clinical trials which also fall under the scope of the relevant part of [the regulations on medical devices and in vitro medical devices], no additional submission or notification procedure shall be required.
Amendment 294 #
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 appropriate statistical approaches, designstate of the trial and methodology (including sample size and randomisation, comparator and endpoints); art of clinical trial design and methodology (including when relevant sample size allowing for a stratified analysis by age and gender and randomisation, comparator and endpoints); the extent to which the clinical trial addresses issues identified as a priority by patients (including the extent and nature of patient involvement in the trial design);
Amendment 350 #
Proposal for a regulation
Article 8 – paragraph 1 a (new)
Article 8 – paragraph 1 a (new)
1 a. Conditions to authorisation can only be related to aspects covered by Article 7 (1). Without prejudice to Article 87, no additional submissions or approvals may be requested.
Amendment 376 #
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. In the assessment, the view of at least one person whose primary area of interest is non-scientific shall be taken into account. The view of at leastn Ethics Committee shall be taken into account. Procedures shall be put in place to allow the sponsor to appeal. The Commission shall develop guidelines one patient shall be taken into accountinvolvement based upon existing good practices.
Amendment 410 #
Proposal for a regulation
Article 16 – paragraph 1 a (new)
Article 16 – paragraph 1 a (new)
For the substantial modifications as defined by Article 35, the sponsor shall submit the application dossier within 15 days from the decision of the sponsor to temporarily halt or terminate the trial.
Amendment 471 #
Proposal for a regulation
Article 29 – paragraph 3
Article 29 – paragraph 3
3. The subject shall be provided with a contact point where he or she may obtain further informationinformation on the results of the clinical trial that he or she has participated in, once it has come to an end, unless the subject specifies at any point of his/her participation that he/she does not wish to be informed. In case it is no longer possible to contact the subject, the making publicly available of the results by means of appropriate databases or publications shall be considered sufficient.
Amendment 494 #
Proposal for a regulation
Article 31 – paragraph 1 – point h
Article 31 – paragraph 1 – point h
(h) some direct benefit for the group of patients is obtainthe goal of the clinical trial is to improve the management of a subject's condition or related fprom the clinical trialblems (e.g. improved quality of life).
Amendment 524 #
Proposal for a regulation
Article 34 – paragraph 1 – subparagraph 2
Article 34 – paragraph 1 – subparagraph 2
That notification shall be made within 1590 days from the end of the clinical trial in relation to that Member State.
Amendment 525 #
Proposal for a regulation
Article 34 – paragraph 2 – subparagraph 2
Article 34 – paragraph 2 – subparagraph 2
That notification shall be made within 1590 days from the end of the clinical trial.
Amendment 541 #
Proposal for a regulation
Article 34 – paragraph 3 a (new)
Article 34 – paragraph 3 a (new)
3a. In the event of non-compliance by the sponsor with the obligation referred to in paragraph 3, and in the absence of prospective and appropriate justification provided to the Member States concerned through the portal , financial penalties shall be imposed by the Member States concerned.
Amendment 544 #
Proposal for a regulation
Article 34 – paragraph 4
Article 34 – paragraph 4
4. For the purpose of this Regulation, if a suspended or temporarily halted clinical trial is not restarted, the date of the decision of the sponsor not to restart the clinical trial shall be considered as the end of the clinical trial. In the case of early termination, the date of the early termination shall be considered as the date of the end of the clinical trial. After 12 months of temporary halt, and in the absence of appropriate prospective justification provided to the Member States concerned, the data from the clinical trial shall be submitted to the EU database, even if incomplete. The reasons for early termination of a clinical trial shall be published in the EU database.