Activities of Dennis de JONG related to 2018/2185(DEC)
Shadow reports (1)
REPORT on discharge in respect of the implementation of the budget of the European Medicines Agency (EMA) for the financial year 2017 PDF (187 KB) DOC (70 KB)
Amendments (5)
Amendment 3 #
Motion for a resolution
Paragraph 7
Paragraph 7
Amendment 6 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses that the Agency’s clients - the pharmaceutical industry - pay for the procedure, not for the outcome of the Agency’s assessments; understands that according to the Agency it considers its recommendations to be made independently and that they, therefore, do not create conflicts of interest, in respect of which any potential risks are however duly considered, prevented and mitigated; expresses, however, concern at the potential conflict of interest that can arise if the Agency have to rely on membership fees as its main source of income; emphasizes the need for a steady and predictable flow of income from the Union budget, which is crucial also to planning, rather than having to rely on fees, which are unpredictable and vary from year to year;
Amendment 7 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Welcomes the fact that the Agency also requests all IT consultants to sign individual declarations of interest and confidentiality undertaking at the beginning of their assignment;
Amendment 9 #
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15 a. Welcomes the inquiry that the European Ombudsman opened into the arrangements that the Agency has in place for engaging with medicine producers before they apply for authorisations to market their medicines in the Union and welcomes the fact that all interested parties are invited to put forward their comments on this issue, especially since the Agency’s income on fees and charges related to marketing authorisations increased by 14 million euros;
Amendment 10 #
Motion for a resolution
Paragraph 15 b (new)
Paragraph 15 b (new)
15 b. Acknowledges from the Agency that Pre-submission meetings contribute to the development of medicines; notes that in the light of the pre-submission meetings, the experts of CHMP perform both the role of consultant as of evaluator of the marketing authorisation applications; calls upon the Agency to at least publish a list of pre-submission activities, once the marketing authorisation has been given;