Activities of Jutta PAULUS related to 2019/2073(DEC)
Shadow opinions (1)
OPINION on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2018
Amendments (4)
Amendment 1 #
Draft opinion
Paragraph 2
Paragraph 2
2. 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; and stresses its concerns that the high reliance on direct fees from industry may compromise the public perception of the Agency's independence;
Amendment 3 #
Draft opinion
Paragraph 5
Paragraph 5
5. Stresses that a number of the Agency’s activities were scaled back, delayed or postponed due to Brexit or other external circumstances; notes with concern that the Agency pointed to a lack of adequate resources for facing a workload that is increasing due to new tasks and legislation, and specifically to the loss of short term contract staff due to relocation and specifics of labour legislation in the Netherlands; 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 Brexit;
Amendment 4 #
Draft opinion
Paragraph 6
Paragraph 6
6. Highlights the fact that in 2018, the Agency recommended 94 new medicines for marketing authorisation (84 for human use and 10 for veterinary use), and that those included 46 new active substances (42 for human use and 4 for veterinary use); notes that in 2018, in the framework of its pharmacovigilance activities, the Agency recommended the immediate suspension and recall of a medicine for multiple sclerosis due to serious and sometimes fatal immune reactions, and the suspension of several antibiotics;
Amendment 7 #
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Welcomes that, in February 2018, the General Court upheld, in three landmark judgments, the Agency's decision to release documents in accordance with Regulation (EC) No 1049/20011a regarding public access to European Parliament, Council and Commission documents; whereas two decisions of the General Court have been appealed by pharmaceutical companies; _________________ 1aRegulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).