7 Amendments of Bas EICKHOUT related to 2019/2073(DEC)
Amendment 8 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Notes that the Court has identified a horisontal trend across agencies in the use of external staff hired in IT consultancy roles; calls for the dependency on external recruitment in this important and sensitive area to be reduced as much as possible to limit any potential risks;
Amendment 11 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Recalls that the Agency is a fee- funded agency, with 89,69 % of its 2018 revenue stemming from fees paid by the pharmaceutical industry, 10,28 % stemming from the Union budget and 0,03 % stemming from external assigned revenue; is concerned that he high reliance on direct fees from industry may compromise the public perception of the Agency's independence;
Amendment 13 #
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13 a. Welcomes that, in February 2018, the General Court of the European Court of Justice upheld, in three landmark rulings, the Agency's decision to release documents in accordance with Regulation (EC) No 1049/2001 of the European Parliament and of the Council on Access to European Parliament, Council and Commission Documents;
Amendment 14 #
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13 b. Welcomes that, on 22 January 2020, the Court of Justice upheld the Agency’s policy of Access to documents in its appeal rulings in the following cases: PTC Therapeutics International/EMA and MSD Animal Health Innovation and Intervet international/EMA;
Amendment 15 #
Motion for a resolution
Paragraph 13 c (new)
Paragraph 13 c (new)
13 c. Regrets that the implementation of the Agency's policy on publication of clinical data has been put on hold as part of its business continuity plan, which was put in place to deal with the consequences of the United Kingdom's decision to withdraw from the European Union;
Amendment 17 #
Motion for a resolution
Subheading 6 a (new)
Subheading 6 a (new)
Ombudsman recommendations (To be inserted before paragraph 16 a(new))
Amendment 18 #
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16 a. Notes that in its inquiry on how the Agency engages with medicine developers in the period leading up to applications for authorisations to market new medicines in the Union, the Ombudsman suggested the Agency should introduce improvements to: - Ensure that there is a separation between those responsible for providing scientific advice to a medicine developer and those subsequently involved in evaluating an MAA for the same medicine; - take into account whether individuals were already involved as coordinators in providing advice on the same medicine in the pre-submissionstage when appointing rapporteurs to evaluate MAAs; - document and publish the reasons for its decision to appoint as a rapporteur an expert who had a prominent role in providing advice for the same medicine during the pre-submission phase, - ensure that at least one of the two rapporteurs had no prominent role in the pre-submission activities concerning that medicine; - attach to the EPAR a detailed log of all relevant pre-submission activities, including the names of the experts involved;