Activities of Karin KADENBACH related to 2016/2169(DEC)
Shadow opinions (1)
OPINION on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2015
Amendments (6)
Amendment 7 #
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. 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 and coherence in adjusting the number of establishment plan posts for staff working on tasks financed by applicants’ fees, in line with increasing demand;
Amendment 19 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Welcomes the information provided by the Agency to the discharge authority on its current contractual commitments and liabilities linked to its physical presence in the UK; notes with concern that the Agency’s rental contract until 2039 does not include an early termination clause to release the Agency from the liabilities of rent and associated costs, and that the payable rent for the remaining period from 2017 to 2039 is estimated at EUR 347,6 million; acknowledges that the absence of a break clause was noted in the opinion of the Committee on Budgets of 24 May 2011 and that the rental agreement was signed in 2011 when a potential exit of the UK from the Union was not foreseeable; however, the costs associated with the relocation would reasonably be expected to be considered in the negotiations on the withdrawal agreement between the Union and the UK Government; asks the Agency to report to the discharge authority on any developments on this matter;
Amendment 20 #
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. 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; asks also in this respect for the Agency to produce a comprehensive Business Continuity Plan which deals with the double and connected risks of budgetary and business volatility;
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;