3 Amendments of Miriam DALLI related to 2016/2169(DEC)
Amendment 20 #
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Recalls that the workload of the Agency is constantly growing and reflected in the budgetary increases in income from fees charged to applicants; notes with concern that the imposed staff cuts in recent years included staff working on tasks financed by applicants' fees without regard to the workload involved; strongly supports, therefore, the introduction of flexibility in adjusting the number of establishment plan posts for staff working on tasks financed by applicants' fees, in line with increasing demand;
Amendment 22 #
Draft opinion
Paragraph 8 b (new)
Paragraph 8 b (new)
8 b. Stresses the risk of budgetary volatility faced by the Agency as a consequence of the outcome of the UK referendum on Union membership; proposes, in the spirit of sound financial management, that the Agency be authorised to maintain a budgetary reserve to respond to unforeseen costs and unfavourable exchange rate fluctuation that may need to be incurred in 2017, or beyond, as a consequence of that decision, to ensure that the Agency can continue to carry out its tasks effectively;
Amendment 23 #
Draft opinion
Paragraph 8 c (new)
Paragraph 8 c (new)
8 c. Acknowledges that the Agency launched a pilot project in March 2014 on the safe use of adaptive pathways; notes that that pilot project aims to identify the appropriate tools within the current regulatory framework to bring to market medicines that address unmet medical needs for a defined patient population, and to ensure that marketing authorisation will only be granted if there is a positive balance of benefits and risks, without compromising patient safety or changing the standards of regulatory approval;