Activities of Dennis de JONG related to 2017/2154(DEC)
Shadow reports (1)
REPORT on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2016 PDF (333 KB) DOC (69 KB)
Amendments (6)
Amendment 10 #
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16 a. 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 the Committee for Medicinal Products for Human Use 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;
Amendment 11 #
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16 b. Acknowledges that approvals of marketing authorisation applications are based on three criteria: efficacy, quality and safety; notes that a fourth requirement should be added: Added Therapeutic Value (ATV), comparing a medicine with the best available drug, instead of comparing it to placebos;
Amendment 12 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Notes with satisfaction that the CVs and declarations of interests of all Management Board members are published on the Agency's website; notes that no breach of trust procedures were initiated for Management Board members in 2016;
Amendment 13 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20 a. Asks the Agency for clarification concerning the hiring of and dependence on IT consultants for IT projects; notes that no methodology had been put in place prior to the start of the projects, affecting the supervision and monitoring by the management; is concerned about the limited supervision of the external consultants as a result of the contracts used and the fact that performance takes place off-site and in other Member States, resulting, therefore, in delays in the projects’ implementation;
Amendment 14 #
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20 a. Notes that the relocation of the Agency could lead to staff leaving the Agency; calls therefore on the Agency to make sure that revolving door rules are strictly applied in each case;
Amendment 23 #
Motion for a resolution
Paragraph 34
Paragraph 34
34. Points out from the Court’s report that the Agency’s 2016 budget was financed 95 % by fees from pharmaceutical companies and 5 % from Union funds; takes note that a future decrease of the Agency’s revenue resulting from the UK’s decision to leave the Union is possiblstresses that the funding from pharmaceutical companies has increased in 2016, comparing to 2015 and is concerned about the influence of the industry on the Agency as of this dependence;