Activities of Benedek JÁVOR related to 2014/2102(DEC)
Shadow reports (1)
REPORT on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2013 PDF (174 KB) DOC (94 KB)
Shadow opinions (1)
OPINION on Discharge 2013: European Medicines Agency
Amendments (4)
Amendment 3 #
Draft opinion
Paragraph 4
Paragraph 4
4. Reiterates the important role of the Agency in protecting and promoting public and animal health by assessing and supervising medicines for human or veterinary use; welcomes the annual declarations and the policy on the handling of conflict of interests, last updated and endorsed by the Management Board in March 2012, and invites the Agency to further strengthen its policy on the management and handling of conflicts of interests in order to ensure independence and transparency in all work areas of the Agency;
Amendment 9 #
Motion for a resolution
Paragraph 7
Paragraph 7
7. Acknowledges from the Agency that the transparency criteria for partner, patient, healthcare and consumer organisations has been revised during 2014 in order to increase the transparency of funding; notes the adoption of the document with detailed criteria regarding the evaluation of financial information from patients, consumers and healthcare professionals organisations; notes furthermore that this document is used for assessing the organisations’ eligibility to participate in the dialogue with the Agency; recalls that the document also states that the organisations have to declare any conflict of interests at the start of the meetings through which the dialogue is commenced; notes with regret the reduction of cool-off periods from 5 to 3 years; furthermore, notes with regret that the arbitrary distinction between direct and indirect conflicts of interest has been kept;
Amendment 15 #
Motion for a resolution
Paragraph 8 c (new)
Paragraph 8 c (new)
8 c. Notes with regret the Agency's understanding of what constitutes commercial confidential information (CCI) is far too broad and includes companies to redact key data about the trial design, methods, and calls on the Agency to properly implement the provisions of the Clinical Trials Regulation (EU) No 536/2014 especially with regard to clinical trial data not to be considered CCI;
Amendment 17 #
Motion for a resolution
Paragraph 8 e (new)
Paragraph 8 e (new)
8 e. Calls on the Agency to publish on its website detailed reports of the scientific advice provided by the Agency to pharmaceutical companies during the drug development and pre-registration process at the time of trial authorization and in any case not later than 12 months after the end of the trial; notes that advice provided by regulators to companies on drug development and pre-registration plans cannot be considered commercially confidential information since there is an overriding public interest in disclosure;