title: 2011/584/EU: Decision of the European Parliament of 10 May 2011 on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2009#Resolution of the European Parliament of 10 May 2011 with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2009

text:
               27.9.2011

               EN

               Official Journal of the European Union

               L 250/173

         DECISION OF THE EUROPEAN PARLIAMENT
   of 10 May 2011
   on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2009
   (2011/584/EU)
   THE EUROPEAN PARLIAMENT,

               —

               having regard to the final annual accounts of the European Medicines Agency for the financial year 2009,

               —

               having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2009, together with the Agency’s replies (1),

               —

               having regard to the Council’s recommendation of 15 February 2011 (05892/2011 — C7-0052/2011),

               —

               having regard to Article 276 of the EC Treaty and Article 319 of the Treaty on the Functioning of the European Union,

               —

               having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Article 185 thereof,

               —

               having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council (3) establishing a European Medicines Agency, and in particular Article 68 thereof,

               —

               having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (4), and in particular Article 94 thereof,

               —

               having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,

               —

               having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A7-0153/2011),

               1.

               Postpones its decision on granting the Executive Director of the European Medicines Agency discharge in respect of the implementation of the Agency’s budget for the financial year 2009;

               2.

               Sets out its observations in the resolution below;

               3.

               Instructs its President to forward this Decision and the resolution that forms an integral part of it to the Executive Director of the European Medicines Agency, the Council, the Commission and the Court of Auditors, and to arrange for their publication in the Official Journal of the European Union (L series).

            The President

         Jerzy BUZEK

            The Secretary-General

         Klaus WELLE

      (1)  OJ C 338, 14.12.2010, p. 28.

      (2)  OJ L 248, 16.9.2002, p. 1.

      (3)  OJ L 136, 30.4.2004, p. 1.

      (4)  OJ L 357, 31.12.2002, p. 72.

      RESOLUTION OF THE EUROPEAN PARLIAMENT
      of 10 May 2011
      with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2009
      THE EUROPEAN PARLIAMENT,

                  —

                  having regard to the final annual accounts of the European Medicines Agency (EMEA) for the financial year 2009,

                  —

                  having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2009, together with the Agency’s replies (1),

                  —

                  having regard to the Council’s recommendation of 15 February 2011 (05892/2011 — C7-0052/2011),

                  —

                  having regard to Article 276 of the EC Treaty and Article 319 of the Treaty on the Functioning of the European Union,

                  —

                  having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Article 185 thereof,

                  —

                  having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council (3) establishing a European Medicines Agency, and in particular Article 68 thereof,

                  —

                  having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (4), and in particular Article 94 thereof,

                  —

                  having regard to the Internal Audit Service’s Annual Internal Audit Report on the European Medicines Agency for 2009,

                  —

                  having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,

                  —

                  having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A7-0153/2011),

                  A.

                  whereas the Court of Auditors, in its report on the annual accounts of the European Medicines Agency for the financial year 2009, qualified its opinion on the legality and regularity of the underlying transactions,

                  B.

                  whereas on 5 May 2010 Parliament granted the Executive Director of the Agency discharge for implementation of the Agency’s budget for the financial year 2008 (5), and in its resolution accompanying the discharge decision, inter alia:

                              —

                              was concerned by the Court of Auditors’ findings that the budget appropriations carried over and cancelled have amounted to EUR 36 000 000 (19,7 % of the budget) and EUR 9 700 000 (5,3 % of the budget) respectively,

                              —

                              called on the Agency to improve the quality of its procurement procedures in order to put an end to the shortcomings identified by the Court of Auditors (for instance, as regards the application of evaluation methods for the price criteria and as regards the essential need for justifications for the choice of procedures),

                  C.

                  whereas the budget of the Agency for 2009 was EUR 194 000 000, which is an increase of 6,28 % on the financial year 2008,

                  D.

                  whereas the Agency’s budget is financed both from the Union budget, which accounted for 18,52 % of total revenue in 2009, and, to a greater extent, from fees paid by pharmaceutical companies, and whereas the Union’s general contribution consequently decreased by 9,2 % between 2008 and 2009,

         General considerations

                  1.

                  Is seriously concerned with the Agency’s replies to significant issues raised by the Court of Auditors and the Internal Audit Service (IAS), such as:

                              (i)

                              the management of procurement procedures;

                              (ii)

                              the lack of respect to implementing procedures regarding the identification and management of conflicts of interest for its staff and experts;

                              (iii)

                              the criteria used for recruiting staff;

                  2.

                  Considers, in particular, that the abovementioned aspects could lead to the possibility of:

                              (i)

                              persistent errors in the management of procurement procedures, such as the ones found in 2009 corresponding to a significant amount of the Agency’s total budget, which could compromise the legality and regularity of the transactions underlying the Agency’s accounts;

                              (ii)

                              potential risks to the independence of experts/staff involved in the evaluation of medicinal products;

                              (iii)

                              potential deficiencies in staff/experts’ recruitment which could not only lead to disqualification of competent candidates and/or recruitment of less qualified candidates but also might have negative effects on the quality of the Agency’s scientific assessment work;

         Budgetary and financial management

         Procurement procedures

                  3.

                  Is concerned at the Court of Auditors’ findings of errors in the procurement procedures corresponding to a significant amount of the Agency’s total budget for the financial year of 2009; stresses that in 2008 the Court of Auditors already identified shortcomings in this matter and, in particular, in the application of evaluation methods for the price criteria and in the justification for the choice of procedures;

                  4.

                  Acknowledges, in particular, that in a number of procedures for the procurement of large IT framework contracts of an estimated value of EUR 30 000 000 the Agency made several errors in 2009 at the moment of opening the procedure such as:

                              (i)

                              arithmetical errors in the evaluation of the award criteria;

                              (ii)

                              inappropriate documentation of the evaluation by a member of the evaluation committee;

                              (iii)

                              a lack of evidence that the evaluation method of the selection criteria had been applied consistently which was thus open to interpretation;

                              (iv)

                              a lack of checks to mitigate the risk of errors when opening a negotiated procedure which, in turn, did not guarantee that best value for money was achieved as a result of errors in the implementation of the award criteria;

                  5.

                  Acknowledges, also, that in two other negotiated procurements of EUR 5 300 000 and EUR 4 000 000 with a single supplier, several errors were again made at the moment of opening the procedure such as:

                              (i)

                              no formal invitation to tender being issued;

                              (ii)

                              no detailed technical specifications being prepared in advance;

                              (iii)

                              technical specifications not clearly defining all the products to be purchased before the negotiation started;

                              (iv)

                              no evaluation committee being appointed;

                              (v)

                              no evaluation report being prepared;

                  6.

                  Takes note therefore, that the Agency failed to comply with various requirements of the relevant procurement regulations;

                  7.

                  Is not ready to accept that the Agency was not able to put in place a control system to avoid or detect in time the above persistent errors which undermine the legality and regularity of the transaction underlying the Agency’s accounts; accordingly, urges the Agency to improve the quality of its procurement procedures in order to put an end to the shortcomings identified by the Court of Auditors;

                  8.

                  Calls on the Agency to set up a multiannual procurement plan which shall ensure stronger technical and procedural controls and to report to the discharge authority on this matter by 30 June 2011;

                  9.

                  Calls on the Agency to ensure that the results of procurement procedures are verified before contracts are awarded; expects that detailed technical specifications shall always be prepared, in view of the Court of Auditors’ findings;

         Carry-over appropriations

                  10.

                  Is concerned that the Court of Auditors has reported a carry-over of EUR 19 500 000 (38 % of the Agency’s commitments) and that approximately EUR 14 800 000 of this carry-over was for activities as yet not implemented (or, in some cases, goods not received) at the year-end; stresses that this situation indicates delays in the implementation of activities financed from Title II (Buildings, equipment and miscellaneous operating expenditure activities) of the Agency’s budget and that the Agency is not in accordance with the budgetary principle of annuality; has assessed the answer by the Agency on the observations and welcomes the efforts to reduce carry-overs by the Agency; encourages the Agency to continue this process in order to apply fully the principle of annuality;

                  11.

                  Points out that the Court of Auditors had already reported a high level of carry-overs in previous financial years and is concerned that this situation is at odds with the annuality principle; notes, in particular, that the 2008 budget appropriations carried over and cancelled amounted to EUR 36 000 000 (19,7 % of the 2008 budget) and EUR 9 700 000 (5,3 % of the 2008 budget) respectively;

         Revenue from fees

                  12.

                  Calls on the Agency to ensure better coordination between its financial and scientific services in order to remedy the unacceptable, long delay for recovery orders; notes, in fact, that the Court of Auditors reported that two recovery orders (EUR 226 200 and EUR 110 200), out of 10 tested, had a very long delay (21 and 5 months respectively), in breach of the Agency’s internal rules;

                  13.

                  Emphasises that the Agency’s budget is financed both from the Union budget and fees paid by the pharmaceutical industry applying for or maintaining a Union marketing authorisation; notes, however, that the contribution from the Union budget represents only 18,7 % of the overall budget and has decreased over the years, for example, in 2005 the contribution represented 22,7 %; stresses that the overall budget available to the Agency was EUR 194 389 000;

         Foreign exchange contracts

                  14.

                  Expects the Agency to prudently manage its longstanding policy of entering into a forward foreign exchange contract in order to hedge part of its administrative budget against unfavourable fluctuations in the sterling exchange rate; expects the Agency to prudently manage such transactions to avoid exchange losses, such as those in 2009 of EUR 900 000; points out that this is a recurrent observation made by the Court of Auditors; requests the Agency to communicate its revised treasury policy to Parliament’s competent committee without delay; will monitor the revised treasury policy;

                  15.

                  Notes from the Agency that the treasury policy has been revised, adopted and formally approved by the Agency’s Audit Advisory Committee; calls on the Agency to provide Parliament with an overview of the implementation of the revised treasury policy before 30 June 2011;

         Performance

                  16.

                  Considers the assessment of the adequacy and effectiveness of the systems in place to support the provision of scientific advice for human medicines in the Agency as an important tool to measure the Agency’s performance; acknowledges that the IAS performed audits and found critical deficiencies in this respect;

         Management of conflicts of interest

                  17.

                  Finds it unacceptable that the Agency does not apply the relevant rules effectively, resulting in the fact that there is no guarantee that the evaluation of human medicines is performed by independent experts; points out that 12 ‘very important’ and one ‘critical’ recommendation from several earlier IAS Annual Audit Reports on the Agency, most of them concerning the independence of experts, were still not implemented in 2009, while the oldest recommendation dates back to 2005;

                  18.

                  Takes note of the employment of the Agency’s former Executive Director by a consultancy that advises, among others, pharmaceutical companies on developing new medication and reducing the period to their market introduction; stresses that this move casts some doubt on the actual independence of the Agency; notes that Article 16 of the Staff Regulations of Officials of the European Union (6) grants wide discretionary power on the Management Board to allow or forbid this type of employment; notes that after consenting to the future employment of the Agency’s former Executive Director, the Management Board eventually decided to set limitations with regards to his new and future professional activities; asks, nevertheless, that the Agency provides the discharge authority, by 30 June 2011, with a report that lists all comparable cases that have occurred since the creation of the Agency and explains thoroughly the Management Board’s decision in each case;

                  19.

                  Considers it unacceptable that the Agency is not complying effectively with its Code of Conduct by setting out principles and guidance on independence and confidentiality applicable to the Management Board and committees’ members, experts and Agency’s staff; expects the Agency to assess thoroughly, before the allocation of project team leaders to products, whether the interests declared by staff members might influence their impartiality and independence; urges, in addition, the Agency to document and assess its controls and file the relevant allocation decisions which must be made available on its website;

                  20.

                  Stresses that the Agency’s reputation could be affected in cases where evaluations can be challenged on the grounds of possible conflicts of interest;

                  21.

                  Urges the Agency to inform the discharge authority of the steps it has taken to ensure the independence of its experts since its inception;

                  22.

                  Wonders why the Court of Auditors’ reports since 2006 on the Agency’s annual accounts make no mention of any deficiencies with regard to the assessment of experts’ independence;

                  23.

                  Asks to be informed if and how the experts and staff dealing with any of the benfluorex group of drugs were screened on their independence and how their interests declared were verified;

         Procedures supporting the provision of scientific evaluation for human medicines

                  24.

                  Considers it unacceptable for the Agency to allow the information in its files on human medicines to be incomplete; urges, in this respect, the Agency to guarantee that key information is easily retrieved and all relevant guidelines on the filing system are in place;

                  25.

                  Asks the Agency, moreover, to complete and regularly update the European Experts Database as required by Regulation (EC) No 726/2004, and to keep the discharge authority informed; urges also the Agency to allow Siamed and product overview databases for efficient retrieval of information;

         Role of the Agency and national competent authorities

                  26.

                  Urges the Agency to inform the discharge authority of the terms of its agreement with Member States on the roles and transfer of tasks to national competent authorities when facing subjects such as the independence of committees, experts and the evaluation process, since the agreement came into effect, and of the level of its implementation, including a detailed record of how it has evolved over time; considers the Agency responsible for the implementation of pre-existing procedures on the identification and management of conflicts of interest for its experts until this agreement with Member States is fully implemented;

         Scientific advice

                  27.

                  Welcomes the efforts of the Agency to provide more scientific advice at the early stages of the development of new medicines as well as the introduction of measures to accelerate the assessment of medicines that are of critical importance to public health and to accelerate the development and implementation of telematics’ programmes;

         Human resources management

                  28.

                  Calls on the Agency to ensure that sensitive tasks are not assigned to interim staff; acknowledges, in fact, that the Agency hires interim staff (32 in 2009) on the condition that the candidates have passed the tests for contract agents and some of the interim staff perform sensitive tasks or have access to sensitive information; stresses the risks of potential security breaches linked to interim staff’s access to sensitive information or unawareness by interim staff of the procedure to follow;

                  29.

                  Calls on the Agency to strengthen its recruitment process and ensure its documentation is correctly managed; acknowledges, in fact, that the IAS found deficiencies in this respect; stresses, also, that insufficient documentation in recruitment procedures reduces the possibility for the Agency to respond to allegations of unequal treatment of candidates and/or arbitrary decisions on recruitment of staff; considers, furthermore, that to the extent that competition is limited, resulting recruitment may not represent the optimal choice and human and financial resources may be used inefficiently;

         Internal audit

                  30.

                  Considers it unacceptable that the Executive Director’s statement of assurance, dated 13 May 2010, does not mention any reservations, and is consequently inconsistent with the undertaking given in the Code of Conduct adopted by the Agency in the light of the statements of assurance from the IAS and the Court of Auditors;

                  31.

                  Points out that the Executive Director’s report is required to contain a summary of the reports from the IAS to the discharge authority, including:

                              (i)

                              the number and types of internal audits conducted by the IAS;

                              (ii)

                              all the recommendations made (including any that may have been rejected by the Agency); and

                              (iii)

                              all the measures taken on the basis of those recommendations;

                        wonders whether these requirements were fulfilled in previous years, and asks the Agency to forward the IAS reports since 2007 to the discharge authority by 30 June 2011;

                  32.

                  Notes the Agency’s initiative of providing the discharge authority with the IAS Annual Internal Audit Report on the Agency; considers that this should be the normal practice of transparency and expects that all other agencies will follow this practice;

                  33.

                  Acknowledges that, out of the 32 recommendations of the IAS, one is ‘critical’ on the implementing procedures involving experts and 12 are ‘very important’ mainly on human resources management, on management of staff’s conflicts of interest and on other procedures supporting the provision of scientific evaluation for human medicines in the Agency; calls, therefore, on the Agency to inform the discharge authority about the precise content of these recommendations without delay; urges the Agency to rapidly implement the IAS recommendations and to provide the discharge authority with a complete overview of measures taken and implemented to properly address these recommendations by 30 June 2011; asks, in addition, the Court of Auditors to monitor and inform the discharge authority of the efficiency of the measures taken;

         Actions to be taken by the Agency by 30 June 2011

                  34.

                  Urges the Agency’s Executive Director, in cooperation with the IAS, to undertake a thorough verification of the effective use of the existing procedures regarding the identification and management of conflicts of interest for its staff and experts and to communicate the results to the discharge authority by 30 June 2011;

                  35.

                  Expects the Governing Board swiftly to adopt an action plan to remedy the shortcomings in the procurement procedures; asks, in particular, the Agency’s Executive Director, in cooperation with the IAS and the parent directorate-general (DG), to draft this action plan which shall include specific measures and a timetable for implementation; expects the Agency to communicate these specific measures to the discharge authority by 30 June 2011;

                  36.

                  Calls on the Agency, therefore, to inform the discharge authority by 30 June 2011 of the measures taken and the improvements made in respect of all these areas of concern;

                  37.

                  Refers, in respect of the other observations accompanying its Decision on discharge, which are of a horizontal nature, to its resolution of 10 May 2011 (7) on the performance, financial management and control of the agencies.

         (1)  OJ C 338, 14.12.2010, p. 28.

         (2)  OJ L 248, 16.9.2002, p. 1.

         (3)  OJ L 136, 30.4.2004, p. 1.

         (4)  OJ L 357, 31.12.2002, p. 72.

         (5)  OJ L 252, 25.9.2010, p. 164.

         (6)  OJ L 56, 4.3.1968, p. 1.

         (7)  Texts adopted, P7_TA(2011)0163 (see page 269 of this Official Journal).


title: 2012/602/EU: Decision of the European Parliament of 10 May 2012 on discharge in respect of the implementation of the budget of the European GNSS Agency for the financial year 2010#Resolution of the European Parliament of 10 May 2012 with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget of the European GNSS Agency for the financial year 2010

text:
               17.10.2012

               EN

               Official Journal of the European Union

               L 286/298

         DECISION OF THE EUROPEAN PARLIAMENT
   of 10 May 2012
   on discharge in respect of the implementation of the budget of the European GNSS Agency for the financial year 2010
   (2012/602/EU)
   THE EUROPEAN PARLIAMENT,

               —

               having regard to the final annual accounts of the European GNSS Agency for the financial year 2010,

               —

               having regard to the Court of Auditors’ report on the annual accounts of the European GNSS Agency for the financial year 2010, together with the Agency’s replies (1),

               —

               having regard to the Council’s recommendation of 21 February 2012 (06083/2012 – C7-0051/2012),

               —

               having regard to Article 319 of the Treaty on the Functioning of the European Union,

               —

               having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Article 185 thereof,

               —

               having regard to Regulation (EU) No 912/2010 of the European Parliament and of the Council of 22 September 2010 setting up the European GNSS Agency (3), and in particular Article 14 thereof,

               —

               having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (4), and in particular Article 94 thereof,

               —

               having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,

               —

               having regard to the report of the Committee on Budgetary Control (A7-0127/2012),

               1.

               Grants the Executive Director of the European GNSS Agency discharge in respect of the implementation of the Agency’s budget for the financial year 2010;

               2.

               Sets out its observations in the resolution below;

               3.

               Instructs its President to forward this Decision and the resolution that forms an integral part of it to the Executive Director of the European GNSS Agency, the Council, the Commission and the Court of Auditors, and to arrange for their publication in the Official Journal of the European Union (L series).

            The President

         Martin SCHULZ

            The Secretary-General

         Klaus WELLE

      (1)  OJ C 366, 15.12.2011, p. 112.

      (2)  OJ L 248, 16.9.2002, p. 1.

      (3)  OJ L 276, 20.10.2010, p. 11.

      (4)  OJ L 357, 31.12.2002, p. 72.

      RESOLUTION OF THE EUROPEAN PARLIAMENT
      of 10 May 2012
      with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget of the European GNSS Agency for the financial year 2010
      THE EUROPEAN PARLIAMENT,

                  —

                  having regard to the final annual accounts of the European GNSS Agency for the financial year 2010,

                  —

                  having regard to the Court of Auditors’ report on the annual accounts of the European GNSS Agency for the financial year 2010, together with the Agency’s replies (1),

                  —

                  having regard to the Council’s recommendation of 21 February 2012 (06083/2012 – C7-0051/2012),

                  —

                  having regard to Article 319 of the Treaty on the Functioning of the European Union,

                  —

                  having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Article 185 thereof,

                  —

                  having regard to Regulation (EU) No 912/2010 of the European Parliament and of the Council of 22 September 2010 setting up the European GNSS Agency (3), and in particular Article 14 thereof,

                  —

                  having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (4), and in particular Article 94 thereof,

                  —

                  having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,

                  —

                  having regard to the report of the Committee on Budgetary Control (A7-0127/2012),

                  A.

                  whereas the European GNSS Agency (‘the Agency’) became financially autonomous in 2006,

                  B.

                  whereas the Court of Auditors stated that it was unable to form an opinion on the accounts of the Agency for the financial year 2007 and points out that the entire architecture of the Galileo project was being revised in 2007 and that the Agency’s accounts were prepared in an uncertain legal environment,

                  C.

                  whereas the Court of Auditors nuanced its statement of assurance on the reliability of the annual accounts of the Agency for the financial year 2008 and on the legality and regularity of the underlying transactions,

                  D.

                  whereas the Court of Auditors stated that it has obtained reasonable assurances that the annual accounts of the Agency for the financial year 2009 are reliable and that the underlying transactions are legal and regular,

                  E.

                  whereas the Court of Auditors in its report on the annual accounts of the Agency for the financial year 2010 qualified its opinion with regard to the reliability of its annual accounts for 2010,

                  F.

                  whereas on 10 May 2011 Parliament granted the Executive Director of the Agency discharge for implementation of the Agency’s budget for the financial year 2009 (5), and in its resolution accompanying the discharge decision, inter alia:

                              —

                              urged the Agency to remedy the deficiencies in the final budget published by the Agency on 31 March 2010 as it did not reflect the final budget for 2009 approved by the Administrative Board and did not include revenue,

                              —

                              urged the Agency to remedy the deficiencies in staff selection procedures which infringe the principle of equal treatment in the application of the eligibility criteria in recruitment procedures open to both internal and external candidates,

                              —

                              called on the Agency to remedy the exclusion criteria for the seventh research framework programme (FP7) which were not published and checked,

                              —

                              noted that the discharge authority did not systematically prove that small and medium enterprises criteria, for the potential beneficiaries in one of the topics which were not met, had been verified,

                  G.

                  whereas in 2011 the Agency took the steps required by Parliament to guarantee transparency, equal treatment, and effectiveness in its staff selection procedures,

                  H.

                  whereas the budget of the Agency for the financial year 2010 was EUR 15 900 000 compared to EUR 44 400 000 in 2009, which represents a decrease of 64,19 %; whereas the Agency reported a contribution of the Union to its budget for 2010 of EUR 8 690 000,

         Reliability of the accounts

                  1.

                  Notes that, in keeping with the accounting practice of the Galileo programme, components in the amount of EUR 4 400 000, namely Satellite magneto-torquers, satellite propulsion thrusters, satellite fuel tanks (In Orbit Validation) and ground rubidium atomic clocks (Full Operational Capability), were recorded by the Agency in 2010 as research expenditure;

                  2.

                  Notes that these assets have been recorded as research expenditure instead of being classified as assets held for transfer by the Agency to the Commission; points out that this accounting practice is in line with the Union requirements for the accounting treatment of Galileo components;

                  3.

                  Notes that, in the report sent to Parliament on 28 February 2012, the Agency explained why these components were dealt with in its accounts as described above;

                  4.

                  Takes notes of the Agency’s reply to the Court of Auditors on this respect and acknowledges that the Agency justified not having recorded this equipment as assets in its accounts for the following reasons:

                              —

                              the objective of the IOV/FOC phase is to assess the technical feasibility of the system, which was not validated in 2010, given that the Commission, which administers, and is in charge of, the Galileo programme, does not intend to carry out the validation until later,

                              —

                              according to the Matimop Arrangement the equipment was never intended to be acquired by the Agency and was never and shall never be under its control; this is one of the main conditions for recognition of an asset according to Union accounting standards,

                              —

                              from an accounting perspective it was found to be not prudent to recognise an asset without any economic benefit/value for the Agency,

                              —

                              based on the above and in line with a Commission’s consistent accounting practice in such a situation, the costs for the equipment were booked as research expenditure in 2010;

                  5.

                  Acknowledges in addition the Court of Auditors’ observations that, following the entry into force of Regulation (EC) No 683/2008 of the European Parliament and of the Council of 9 July 2008 on the further implementation of the European satellite navigation programmes (EGNOS and Galileo) (6), most of the activities and assets related to the EGNOS and Galileo programmes were transferred to the Commission in December 2009 but at 31 December 2010 the status of EUR 2 000 000 held by the Agency in respect of technical support from the European Space Agency had still to be determined; notes from the Agency that the transfer of EUR 2 000 000 was finalised on 3 October 2011;

         Budget and financial management

                  6.

                  Takes note from the Agency that the final contribution made by the Union to the Agency for 2010 amounted to EUR 8 690 000 and that this amount includes the initial budget of EUR 5 135 000 complemented by the recovery of surplus of EUR 2 755 000 and an additional amount of EUR 800 000 of payment appropriations to reinforce Title III (Operational expenditure);

                  7.

                  Acknowledges from its Report on Budgetary and Financial Management (RBFM) that the budget of the Agency for the financial year 2010 was subject to one amendment by the Administrative Board; takes note that the amending budget reflected a decision from DG ENTR to reinforce the Agency’s payment appropriations on budget line 3100 ‘Expenditure for studies’ by EUR 800 000 in order to maintain payment capacity on commitments carried over from previous years and on those entered into in 2010;

                  8.

                  Establishes its RBFM that the budget execution rate of the Agency reached 97 % for expenditure financed by the Union operation subsidy and 89 % for the operational activities financed from earmarked revenue; notes in particular that the budget execution rate of the Agency reached:

                              —

                              96 % in terms of commitments and 89 % in terms of payments under Title I (Staff expenditure),

                              —

                              99 % in terms of commitments and 78 % in terms of payments under Title II (Administration expenditure),

                              —

                              99 % in terms of commitments and 60 % in terms of payments under Title III (Operational expenditure),

                        is concerned that under Title III the Agency’s execution rate in terms of payments was only of 60 % compared to 97 % in 2009; welcomes the fact that the Agency has taken the necessary measures to remedy this situation, which have in fact translated into a high out-turn of payments in 2011 (90 % for Title III and 94 % for the budget as a whole);

                  9.

                  Ascertains from the RBFM that two internal transfers of a total value of EUR 205 000 were authorised by the Executive Director in 2010;

                  10.

                  Takes note from its Annual Activity Report (AAR) that the Agency received pre-financing from the Commission amounting to EUR 2 606 675 and EUR 4 556 158 in accordance with the FP7 Delegation Agreement;

         Grant procedures

                  11.

                  Calls on the Agency to rectify the deficiencies identified by the Court of Auditors in the evaluation process as regards the FP7/Galileo/Second Call grant procedures which has a budget of EUR 26 000 000; acknowledges in particular the Court of Auditors’ observations according to which the criteria for assessing the applicants’ financial capacity were not defined and although the status of the applicant determined the maximum reimbursement rate, such status was not verified by the Agency;

                  12.

                  Urges the Agency, in addition, to remedy the weaknesses found by the Court of Auditors on two grant agreements within the sixth research framework programme (FP6)/Third Call; notes in particular that the cost claims submitted by the beneficiaries were based on standard rates, instead of actual costs; reminds the Agency that this is not in compliance with the non-profit principle for Union financial contributions and that the Agency should promptly redress the situation;

                  13.

                  Acknowledges, in addition, the Court of Auditors’ observations according to which five audited grants, related to the FP6, showed delays of between one and three years in their implementation and successive increases in the initial value of the contracts were noted; notes that the Agency justified those delays by stating that the technological leading-edge nature of the activities is subject to constant change and therefore the Agency decided that those amendments and extensions were necessary and useful for the entire Galileo programme; notes that, in any case, the Agency states that it never exceeded the limit laid down in the budget for contracts as a whole;

         Procurement activities

                  14.

                  Notes from its AAR that the Agency had the following procurement activities in 2010:

                              —

                              65 purchase orders corresponding to an overall amount of approximately EUR 900 000,

                              —

                              six negotiated procedures corresponding to an overall amount of EUR 470 000,

                              —

                              three open calls corresponding to an overall amount of EUR 9 400 000;

         Consistency of the Annual Work Programme (AWP) and the AAR

                  15.

                  Notes that the Agency’s AAR does not necessarily mirror its AWP; establishes, in addition, that the objectives of its AWP are rather vague and therefore is quite difficult to assess and check whether they have been fulfilled; urges the Agency, therefore, to improve its AWP in order to allow the discharge authority to better evaluate the efficiency of the Agency; points out that the Agency has taken note of the Court of Auditors’ recommendations, and welcomes the fact that, as a result, the format of the next AWPs will conform to the requirements;

         Human resources

                  16.

                  Urges the Agency to improve the selection procedures in order not to jeopardise the transparency of recruitment; acknowledges the Court of Auditors’ observations according to which in the staff selection procedures audited, threshold scores were not determined for admission to written tests and interviews or for inclusion in the list of suitable candidates;

                  17.

                  Notes from its AAR that the Agency launched 16 recruitment processes and reached a total headcount of 40 by the end of 2010;

                  18.

                  Notes also from its AWP that the Agency provided for 42 total staff, whereas the total staff in employment as at 31 December 2010 were 40 (five more than in 2009): 18 operational, 14 administrative and eight mixed;

         Internal audit

                  19.

                  Acknowledges from its AAR that the Agency finalised its risk management policy and a risk register was developed;

                  20.

                  Notes in addition from the Agency’s AAR that at the end of 2010 there were no critical recommendations open by the Internal Audit Service, but there were five open recommendations related to:

                              —

                              the disclosure of objectives and performance indicators in the AWP,

                              —

                              the need to formalise the appointment of the Accounting Officer by the Administrative Board,

                              —

                              the establishment of adequate financing decisions,

                              —

                              the reinforcement of key controls in grant management,

                              —

                              the update of financial delegations and the regular assessment of ABAC users’ rights;

                  21.

                  Welcomes the fact that, according to the Agency’s annual implementation review of recommendations issued in December 2011, the above mentioned five open recommendations have been implemented;

                  22.

                  Draws attention to its recommendations from previous discharge reports, as set out in the Annex to this resolution;

                  23.

                  Refers, in respect of the other observations accompanying its Decision on discharge, which are of a horizontal nature, to its resolution of 10 May 2012 (7) on the performance, financial management and control of the agencies.

         (1)  OJ C 366, 15.12.2011, p. 112.

         (2)  OJ L 248, 16.9.2002, p. 1.

         (3)  OJ L 276, 20.10.2010, p. 11.

         (4)  OJ L 357, 31.12.2002, p. 72.

         (5)  OJ L 250, 27.9.2011, p. 232.

         (6)  OJ L 196, 24.7.2008, p. 1.

         (7)  Texts adopted, P7_TA(2012)0164 (see page 388 of this Official Journal).

      ANNEX

         EUROPEAN PARLIAMENT RECOMMENDATIONS OVER THE PAST YEARS

                  European GNSS Agency

                  2006

                  2007

                  2008

                  2009

                  Budgetary and financial management

                              —

                              Weaknesses in the operation of the management and control systems: in 12 cases, the initiating official for the transaction did not have the delegated authority and the appropriate financial circuit was not followed

                              —

                              Uncertainties with regard to Galileo and EGNOS project assets

                              —

                              Weaknesses in the management of the budget: absence of a clear link between the Authority’s work programme and the budget, transfers neither adequately justified nor documented, repeated late booking of recovery orders in the budgetary accounts and inconsistent presentation of the budget’s implementation

                              —

                              Even with a de facto 50 % budget reduction, the consumption level of commitment and payment appropriations for operational activities was low: 63 % for commitments an 51 % for payments

                              —

                              Regrets that the Court of Auditors nuanced its statement of assurance on the reliability of the annual accounts for the financial year 2007 and on the legality and regularity of the underlying transactions

                              —

                              Uncertainties with regard to Galileo and EGNOS project assets

                              —

                              Weaknesses in the management of the budget: No proper amending budget was established

                              —

                              Regrets that the Court of Auditors nuanced its statement of assurance on the reliability of the annual accounts for the financial year 2008 and on the legality and regularity of the underlying transactions

                              —

                              Uncertainties with regard to Galileo and EGNOS project assets

                              —

                              The exclusion criteria for the framework programme 7 were not published and checked and the Authority did not systematically evidence that it had verified that the small and medium enterprises criteria for the potential beneficiaries participating in one of the topics were not met

                              —

                              The final budget published by the Authority on 31 March 2010 did not reflect the final budget for 2009 approved by the Administrative Board and did not include its revenue, urges the Authority therefore to remedy the situation and inform the discharge authority of the change

                  Human resources

                  n.a.

                  n.a.

                  n.a.

                              —

                              Deficiencies in staff selection procedures

                              —

                              The need to remedy deficiencies which infringe the principle of equal treatment in the application of the eligibility criteria in recruitment procedures open to both internal and external candidates

                  Internal audit

                  n.a.

                  n.a.

                  Calls on the Agency to fulfil the last two recommendations made by the Internal Audit Service in 2007: i.e. sensitive posts and job description

                  Acknowledges two remaining important IAS recommendations yet to be implemented relate to sensitive posts and job descriptions


title: 2011/758/EU: Decision of the European Parliament of 25 October 2011 on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2009#Resolution of the European Parliament of 25 October 2011 with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2009

text:
               26.11.2011

               EN

               Official Journal of the European Union

               L 313/27

         DECISION OF THE EUROPEAN PARLIAMENT
   of 25 October 2011
   on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2009
   (2011/758/EU)
   THE EUROPEAN PARLIAMENT,
   having regard to the final annual accounts of the European Medicines Agency for the financial year 2009,
   having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2009, together with the Agency’s replies (1),
   having regard to the Council’s recommendation of 15 February 2011 (05892/2011 — C7-0052/2011),
   having regard to its decision of 10 May 2011 (2) postponing the discharge decision for the financial year 2009, and the replies by the Executive Director of the European Medicines Agency,
   having regard to Article 276 of the EC Treaty and Article 319 of the Treaty on the Functioning of the European Union,
   having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (3), and in particular Article 185 thereof,
   having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council (4) establishing a European Medicines Agency and in particular Article 68 thereof,
   having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (5), and in particular Article 94 thereof,
   having regard to the letter of the Chair of the Agency’s Management Board to the Chair of the Committee on Budgetary Control of the European Parliament of 17 June 2011 (EMA/441533/2011),
   having regard to the Agency’s replies to Parliament’s resolution of 10 May 2011 (6) accompanying its abovementioned Decision on discharge for the financial year 2009,
   having regard to the Annual Internal Audit Reports for 2009, 2008 and 2007 of the Commission’s Internal Audit Service (IAS) on the Agency,
   having regard to the final follow-up report on the audits of 2009, 2008 and 2006 of the IAS on the Agency,
   having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,
   having regard to the second report of the Committee on Budgetary Control (A7-0329/2011),

               1.

               Grants the Executive Director of the European Medicines Agency discharge in respect of the implementation of the Agency’s budget for the financial year 2009;

               2.

               Sets out its observations in the resolution below;

               3.

               Instructs its President to forward this Decision and the Resolution that forms an integral part of it to the Executive Director of the European Medicines Agency, the Council, the Commission and the Court of Auditors, and to arrange for their publication in the Official Journal of the European Union (L series).

            The President

         Jerzy BUZEK

            The Secretary-General

         Klaus WELLE

      (1)  OJ C 338, 14.12.2010, p. 28.

      (2)  OJ L 250, 27.9.2011, p. 173.

      (3)  OJ L 248, 16.9.2002, p. 1.

      (4)  OJ L 136, 30.4.2004, p. 1.

      (5)  OJ L 357, 31.12.2002, p. 72.

      (6)  OJ L 250, 27.9.2011, p. 174.

      RESOLUTION OF THE EUROPEAN PARLIAMENT
      of 25 October 2011
      with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2009
      THE EUROPEAN PARLIAMENT,
      having regard to the final annual accounts of the European Medicines Agency for the financial year 2009,
      having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2009, together with the Agency’s replies (1),
      having regard to the Council’s recommendation of 15 February 2011 (05892/2011 — C7-0052/2011),
      having regard to its decision of 10 May 2011 (2) postponing the discharge decision for the financial year 2009, and the replies by the Executive Director of the European Medicines Agency,
      having regard to Article 276 of the EC Treaty and Article 319 of the Treaty on the Functioning of the European Union,
      having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (3), and in particular Article 185 thereof,
      having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council (4) establishing a European Medicines Agency and in particular Article 68 thereof,
      having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (5), and in particular Article 94 thereof,
      having regard to the letter of the Chair of the Agency’s Management Board to the Chair of the Committee on Budgetary Control of the European Parliament of 17 June 2011 (EMA/441533/2011),
      having regard to the Agency’s replies to Parliament’s resolution of 10 May 2011 (6) accompanying its abovementioned Decision on discharge for the financial year 2009,
      having regard to the Annual Internal Audit Reports for 2009, 2008 and 2007 of the Commission’s Internal Audit Service (IAS) on the Agency,
      having regard to the final follow-up report on the audits of 2009, 2008 and 2006 of the IAS on the Agency,
      having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,
      having regard to the second report of the Committee on Budgetary Control (A7-0329/2011),

                  A.

                  whereas the Court of Auditors, in its report on the annual accounts of the European Medicines Agency for the financial year 2009, qualified its opinion on the legality and regularity of the underlying transactions,

                  B.

                  whereas in its abovementioned Decision of 10 May 2011 Parliament decided to postpone its decision on granting the Executive Director of the Agency discharge in respect of the implementation of the Agency’s budget for the financial year 2009,

                  C.

                  whereas the budget of the Agency for 2009 was EUR 194 000 000, which is an increase of 6,28 % on the financial year 2008,

                  D.

                  whereas the Agency’s budget is financed both from the Union’s annual budget, which accounted for 18,52 % of total revenue in 2009, and, to a greater extent, from fees paid by pharmaceutical companies for services which may spread across more than one financial year, and whereas the Union’s general contribution consequently decreased by 9,2 % between 2008 and 2009,

                  E.

                  whereas the discharge authority received replies from the Agency following Parliament’s abovementioned resolution of 10 May 2011,

                  F.

                  whereas in its replies to Parliament, the Agency updated the discharge authority on the level of implementation of the IAS’ recommendations, stating that:

                              —

                              from the 2009 IAS audit on Human Resources Management, one of the three ‘very important’ recommendations has now been implemented and the other two are under way,

                              —

                              from the 2008 IAS audit on Selection administrative procedures supporting the provision of scientific evaluation for human medicines in the Agency, the ‘critical’ recommendation and one ‘very important’ recommendation (management of conflicts of interest of staff & specific guidelines) have respectively been downgraded to ‘very important’ and ‘important’, while three ‘very important’ recommendations have now been implemented,

                              —

                              from the 2005 IAS audit on Implementation of the Internal Control Standards (ICS), one of the two ‘very important’ recommendations has now been implemented,

         General assessment

                  1.

                  Acknowledges receipt of a letter of the Chair of the Agency’s Management Board of 17 June 2011 in which it is stated that the Agency has taken actions to address the 2009 shortcomings; also takes note of the documents and annexes received from the Agency in response to Parliament’s abovementioned resolution of 10 May 2011; also acknowledges receipt of a letter of the Agency’s Acting Executive Director of 10 August 2011, following the questions raised during the debate on discharge to the Agency for 2009 at the meeting of Parliament’s Committee on Budgetary Control of 13 July 2011; regrets, however, that not all the information requested was submitted;

                  2.

                  Notes, however, that the Agency should continue to inform on a three-monthly basis the discharge authority on the results of the actions requested by the discharge authority;

                  3.

                  Underlines that the discharge authority shall continue to carefully monitor during the upcoming discharge procedures the level of implementation of the measures undertaken to address the Agency’s serious weaknesses disclosed by the reports from both the Court of Auditors and the IAS; expects, therefore, the Agency to inform the discharge authority on the actions implemented and their results and to submit the documents requested, especially with regard to the following issues:

                              (a)

                              the process of the adoption by the Management Board of the action plan with specific measures and a timetable for implementation to remedy the shortcomings in the procurement procedures;

                              (b)

                              the thorough verification of the effective use of the existing procedures regarding the identification and management of conflicts of interest for its staff and experts;

                              (c)

                              the submission of the IAS reports according to the Financial Regulation;

         Specific comments

         Procurement procedures

                  4.

                  Notes the information received relating to the control system which sets out to avoid or detect in time the persistent errors in procurement procedures; expects to receive the multiannual procurement plan; accordingly reminds the Agency to continue improving the quality of its procurement system and to comply strictly with the requirements of the relevant rules on public procurement, so as to rectify the shortcomings pointed out by the Court of Auditors;

                  5.

                  Notes the initiation of the actions to develop an action plan on improving procurement procedures; calls on the Agency to proceed promptly with the adoption of an action plan to remedy the shortcomings in the procurement procedures, in particular the errors in managing contract award procedures, by providing for more rigorous technical and procedural checks, and to inform the discharge authority accordingly;

                  6.

                  Recalls that in its 2009 annual report the Court of Auditors stated that the Agency did not carry out enough checks to mitigate the risk of errors on a number of procedures for the procurement of large IT framework contracts; also recalls that the audit showed errors which affected the regularity of these operations and formed the basis for the qualified opinion on the legality and regularity of the transactions underlying the Agency’s accounts by the Court of Auditors;

         Carry-over appropriations

                  7.

                  Points out that in its annual report on the Agency for 2009, the Court of Auditors reported that approximately EUR 14 800 000 of a carry-over of EUR 19 500 000 (38 % of the Agency’s commitments in 2009) was for activities as yet not implemented (or, in some cases, goods not received for services which may spread across more than one financial year) at the year-end; reminds the Agency therefore to take action in this respect and looks forward to receiving assurance from the Court of Auditors on this;

         Revenue from fees

                  8.

                  Takes note of information from the Agency that as of 1 January 2011, the Agency introduced an integrated Enterprise Resource Planning System (ERP) with SAP as the provider to remedy its long delay for recovery orders; takes note that with this new system the Agency feeds the data from its current operational systems (e.g. Siamed) via a dashboard directly into the financial module SAP;

         Foreign-exchange contracts

                  9.

                  Acknowledges the Agency’s commitment to limit its risks due to exchange rate variance and that as of 11 June 2010 it revised its Treasury Policy by: establishing an internal consultation committee to advise the accounting officer on hedging strategies; limiting the hedging to 50 % of estimated requirement; and ensuring that achievable market rates match or are above the budget-costing rate;

         Management of conflicts of interest

                  10.

                  Takes note of the Agency’s replies on the compliance with its Code of Conduct by setting out principles and guidance on independence and confidentiality applicable to the Management Board and members of committees, experts and the Agency’s staff; accordingly expects the Agency to assess thoroughly, before the allocation of project team leaders to products, whether the interests declared by staff members might influence their impartiality and independence; expects that the Agency’s documents on the conflicts of interest shall be updated;

                  11.

                  Takes note of the Agency’s intention to apply the IAS’ recommendation from its 2010 follow-up audit by adopting a risk-based approach and focusing checks on staff who declare interests; calls on the Agency to inform the discharge authority on the timing and plan to apply this IAS’ recommendation before the end of 2011;

                  12.

                  Acknowledges, nevertheless, the Agency’s reply in which it is stated that there is no onus on it to request or monitor the annual declaration of financial interests of experts responsible for evaluating medicinal products, as this lies with the Member States’ competent authorities (Article 126b of Directive 2001/83/EC (7) as amended by Directive 2004/27/EC (8)); calls therefore on the Commission to remind the respective authorities in the Member States of their obligations in this matter;

                  13.

                  Stresses that it is not only the Agency’s reputation that could be affected in cases where evaluations can be challenged on the grounds of possible conflicts of interest but also that such conflicts of interest do not guarantee the optimal protection of European citizens’ health;

                  14.

                  Notes that, as of 1 July 2011, the new electronic Declaration of Interests (e-DoI) form went live and all experts were requested to fill in the new e-DoI and that the e-DoIs of all experts included in the Experts database have been made publicly available on the Agency’s website as of 30 September 2011; also notes that the Memorandum of Understanding between the Agency and each National Competent Authority on the monitoring of the scientific level and independence of the evaluation carried out by the National Competent Authority for services to be provided to the Agency became effective as of 4 July 2011;

                  15.

                  Calls on the Agency to inform the discharge authority on actions taken on issues relating to the effective compliance with its Code of Conduct as regards the management of conflicts of interest;

                  16.

                  Insists, but also warns the Agency, that all the actions mentioned in the respective audit reports, including the one for the year 2010, should be fully implemented before the start of the next discharge procedure;

         Human resources management

                  17.

                  Takes note of the Agency’s reply in which it is stated that it has corrected the deficiencies identified by the IAS for contract agent selection and that revised work instructions and templates have been put in place and the staff have received specific training; accordingly calls on the Agency to keep the discharge authority updated on the level of implementation of these actions; looks forward to the 2010 report of the Court of Auditors to establish whether the assurance from the Agency is well founded;

                  18.

                  Refers, in respect of the other observations accompanying its Decision on discharge, which are of a horizontal nature, to its resolution of 10 May 2011 (9) on the performance, financial management and control of the agencies.

         (1)  OJ C 338, 14.12.2010, p. 28.

         (2)  OJ L 250, 27.9.2011, p. 173.

         (3)  OJ L 248, 16.9.2002, p. 1.

         (4)  OJ L 136, 30.4.2004, p. 1.

         (5)  OJ L 357, 31.12.2002, p. 72.

         (6)  OJ L 250, 27.9.2011, p. 174.

         (7)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

         (8)  OJ L 136, 30.4.2004, p. 34.

         (9)  OJ L 250, 27.9.2011, p. 269.


title: 2012/588/EU: Decision of the European Parliament of 10 May 2012 on discharge in respect of the implementation of the budget of the European Agency for Safety and Health at Work for the financial year 2010#Resolution of the European Parliament of 10 May 2012 with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget of the European Agency for Safety and Health at Work for the financial year 2010

text:
               17.10.2012

               EN

               Official Journal of the European Union

               L 286/246

         DECISION OF THE EUROPEAN PARLIAMENT
   of 10 May 2012
   on discharge in respect of the implementation of the budget of the European Agency for Safety and Health at Work for the financial year 2010
   (2012/588/EU)
   THE EUROPEAN PARLIAMENT,

               —

               having regard to the final annual accounts of the European Agency for Safety and Health at Work for the financial year 2010,

               —

               having regard to the Court of Auditors’ report on the annual accounts of the European Agency for Safety and Health at Work for the financial year 2010, together with the Agency’s replies (1),

               —

               having regard to the Council’s recommendation of 21 February 2012 (06083/2012 – C7-0051/2012),

               —

               having regard to Article 319 of the Treaty on the Functioning of the European Union,

               —

               having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Article 185 thereof,

               —

               having regard to Council Regulation (EC) No 2062/94 of 18 July 1994 establishing a European Agency for Safety and Health at Work (3), and in particular Article 14 thereof,

               —

               having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (4), and in particular Article 94 thereof,

               —

               having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,

               —

               having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on Employment and Social Affairs (A7-0117/2012),

               1.

               Grants the Director of the European Agency for Safety and Health at Work discharge in respect of the implementation of the Agency’s budget for the financial year 2010;

               2.

               Sets out its observations in the resolution below;

               3.

               Instructs its President to forward this Decision and the resolution that forms an integral part of it to the Director of the European Agency for Safety and Health at Work, the Council, the Commission and the Court of Auditors, and to arrange for their publication in the Official Journal of the European Union (L series).

            The President

         Martin SCHULZ

            The Secretary-General

         Klaus WELLE

      (1)  OJ C 366, 15.12.2011, p. 45.

      (2)  OJ L 248, 16.9.2002, p. 1.

      (3)  OJ L 216, 20.8.1994, p. 1.

      (4)  OJ L 357, 31.12.2002, p. 72.

      RESOLUTION OF THE EUROPEAN PARLIAMENT
      of 10 May 2012
      with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget of the European Agency for Safety and Health at Work for the financial year 2010
      THE EUROPEAN PARLIAMENT,

                  —

                  having regard to the final annual accounts of the European Agency for Safety and Health at Work for the financial year 2010,

                  —

                  having regard to the Court of Auditors’ report on the annual accounts of the European Agency for Safety and Health at Work for the financial year 2010, together with the Agency’s replies (1),

                  —

                  having regard to the Council’s recommendation of 21 February 2012 (06083/2012 – C7-0051/2012),

                  —

                  having regard to Article 319 of the Treaty on the Functioning of the European Union,

                  —

                  having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Article 185 thereof,

                  —

                  having regard to Council Regulation (EC) No 2062/94 of 18 July 1994 establishing a European Agency for Safety and Health at Work (3), and in particular Article 14 thereof,

                  —

                  having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (4), and in particular Article 94 thereof,

                  —

                  having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,

                  —

                  having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on Employment and Social Affairs (A7-0117/2012),

                  A.

                  whereas the Court of Auditors stated that it has obtained reasonable assurances that the annual accounts for the financial year 2010 are reliable and that the underlying transactions are legal and regular,

                  B.

                  whereas on 10 May 2011 Parliament granted the Director of the European Agency for Safety and Health at Work discharge for implementation of the Agency’s budget for the financial year 2009 (5), and in its resolution accompanying the discharge decision, inter alia:

                              —

                              called on the Agency to reduce the increased cancellation rate and inform the discharge authority of the actions taken,

                              —

                              called on the accounting officer of the Agency to describe the methodology used in the validation of its accounting system, supports the idea of developing cooperation within the existing Inter Agency Accountants Networks in order to come up with common requirements and develop a common methodology for validation of the accounting systems agencies,

                              —

                              stressed that the carry-forward of EUR 3 500 000 (47 % of the Agency’s operation appropriations) relating to operational activities delays the implementation of the Agency’s activities and is at odds with the budgetary principle of annuality, which is partly because of the multi-annuality of the important projects,

                  C.

                  whereas the overall budget of the Agency for the financial year 2010 was EUR 15 500 000, which represents an increase of 3,3 % over the financial year 2009; whereas the initial Union contribution to the budget of the Agency for 2010 was EUR 13 743 434 compared to EUR 13 800 000 in 2009 (6), which represents a decrease of 0,41 %,

         Budget and financial management

                  1.

                  Recalls that the initial Union contribution to the budget of Agency for 2010 amounted to EUR 13 743 434; notes, however, that EUR 506 566, arising from the recovery of surplus, was added to this which, as a result, makes a total Union contribution of EUR 14 250 000 for 2010;

                  2.

                  Establishes from the annual accounts that the original budget of the Agency for 2010 has been amended twice and that transfers have taken place; calls on the Agency to provide the discharge authority with information on the reasons behind these changes;

                  3.

                  Acknowledges from the Agency’s Annual Activity Report (AAR) that of the budget available in 2010, 96,1 % was committed by the end of the year;

         Carry-over appropriations

                  4.

                  Notes an improvement in the Agency’s carry-over appropriations over the years; notes in particular, that in 2010 it reduced its cancellation rate to 11 % from 19 % in 2009; calls, nevertheless, on the Agency to further improve the situation by avoiding delay in the implementation of its activities;

         Human resources

                  5.

                  Observes from the Agency’s AAR that the total number of staff as of 31 December 2010 stood at 66; notes, in addition, that the staffing is comprised of 44 temporary agents (TA), 21 contract agents (CA) and 1 CA post situated in Networking and Coordination funded from the IPAC2 programme;

                  6.

                  Calls on the Agency to inform the discharge authority about the measures the Agency took to fulfil the below objectives set out in its Work Annual Programme:

                              —

                              organising and monitoring selection procedures for TA and CA,

                              —

                              managing and administering the human resources function in an effective and timely manner,

                              —

                              getting the necessary qualified staff for the Agency to meet the Agency’s strategy and objectives to implement its annual management plans;

         Performance

                  7.

                  Acknowledges from its AAR that the Agency detailed data comparing one year to another so as to enable the discharge authority to assess more effectively the Agency’s performance; considers this a best practice to be followed by the other agencies;

                  8.

                  Welcomes the Agency’s initiative of launching ‘foresight’ on the health and safety impact of technological innovations in ‘green jobs’ by 2020; notes that the dissemination of the results of these projects to their target audiences has now started at the World Congress and in a seminar series; would therefore appreciate receiving the feedback of these initiatives from the Agency;

         Internal audit

                  9.

                  Welcomes the Agency’s initiative of automatically providing to the discharge authority the Internal Audit Service (IAS)’s Annual Internal Audit Report on the Agency; considers this to be an indication of transparency and an example of best practice to be followed by all other agencies; considers that the IAS’s audit reports often help further developed processes and measures mitigating/controlling the Agency’s risks;

                  10.

                  Acknowledges from the Agency that the IAS undertook a follow-up on the open recommendations of past audits; welcomes in particular that in relation to the follow-up of earlier recommendations from the IAS, the internal auditor assessed that all very important recommendations are adequately implemented and closed except the one on validation of accounting systems, which was downgraded to ‘important’ due to partial implementation; calls, therefore, on the Agency to fully implement this recommendation in addition and to inform the discharge authority on the measures taken;

                  11.

                  Notes, in addition, that the IAS performed an audit on website and external communication in November 2010; notes in particular that on this audit the IAS raised seven recommendations, none of them were rated as ‘critical’ but two were considered as ‘very important’ and were related to:

                              —

                              the service level agreement documentation,

                              —

                              the adoption and implementation of a security policy,

                        calls therefore on the Agency to promptly implement these two recommendations and to inform the discharge authority on the measures taken;

                  12.

                  Draws attention to its recommendations from previous discharge reports, as set out in the Annex to this resolution;

                  13.

                  Refers, in respect of the other observations accompanying its Decision on discharge, which are of a horizontal nature, to its resolution of 10 May 2012 (7) on the performance, financial management and control of the agencies.

         (1)  OJ C 366, 15.12.2011, p. 45.

         (2)  OJ L 248, 16.9.2002, p. 1.

         (3)  OJ L 216, 20.8.1994, p. 1.

         (4)  OJ L 357, 31.12.2002, p. 72.

         (5)  OJ L 250, 27.9.2011, p. 201.

         (6)  OJ L 64, 12.3.2010, p. 507.

         (7)  Texts adopted, P7_TA(2012)0164 (see page 388 of this Official Journal).

      ANNEX

         EUROPEAN PARLIAMENT RECOMMENDATIONS OVER PAST YEARS

                  European Agency for Safety and Health at Work

                  2006

                  2007

                  2008

                  2009

                  Performance

                  n.a.

                  n.a.

                              —

                              Calls on the Agency to set out a diachronic analysis of operations carried out in this and the previous years

                              —

                              Congratulates the Agency on having significantly improved its financial management over the last three years; encourages it to continue to strive for the highest standards in budgetary planning, implementation and control

                  Calls on the Agency to set out in a table annexed to the Court of Auditors next report a comparison of the operations that were carried out during the year for which discharge is to be granted and during the previous financial year so as to enable the discharge authority to assess more effectively the Agency’s performance from one year to the next

                  Governance of the Agency

                  n.a.

                  n.a.

                              —

                              The Agency’s governance costs are not insignificant (84-member Governing Board and employs 64 staff)

                  Operating appropriations carried over

                  The budgetary principle of specification was not strictly observed. (The Director signed 19 decisions for approximately EUR 880 000 authorising budgetary transfers from article to article within chapters. Contrary to the Financial Regulation, the Governing Board did not receive the required information)

                  n.a.

                              —

                              Calls in the interests of sound financial management, for the budget forecasts to be adjusted to reflect actual needs (the state of affairs was at odds with the principle of annuality)

                              —

                              Acknowledges that the Agency carried forward EUR 3 500 000 (47 % of its operation appropriations) in respect of the operational activities. Stresses that this situation delays in the implementation of the Agency’s activities and is at odds with the budgetary principle of annuality, which is partly because of the multiannuality of important projects

                              —

                              Calls on the Agency to reduce the increased cancellation rate and inform the discharge authority of the actions taken

                  Procurement procedures

                  n.a.

                  n.a.

                  Calls on the Agency to resolve the problem of using public procurement framework contract beyond its maximum value, in order to give effect to European budgetary law

                  Human resources and internal audit

                  n.a.

                  n.a.

                  Calls on the Agency to take steps to fulfil 14 out of 33 recommendations made by the Internal Audit Service, notes that six of them are considered to be very important: i.e. management of the stakeholders’ expectations and the implementation of certain internal control standards, namely dealing with individual file problems, the annual report on internal control and promoting internal control procedures

                              —

                              Calls on the accounting officer of the Agency to describe the methodology used in the validation of its accounting system, supports the idea of developing cooperation within the existing Inter Agency Accountants Networks in order to come up with common requirements and develop a common methodology for validation of the accounting systems in agencies

                              —

                              Encourages the Agency to revise the checklists to match the specifications of different financial transactions and to make them available to all staff

                              —

                              Calls on the Agency to finalise its documentation procedures

                              —

                              Calls on the Agency to produce an exhaustive list of the main processes to be matched with required procedures and for this list to be systematically updated


title: 2011/568/EU: Decision of the European Parliament of 10 May 2011 on discharge in respect of the implementation of the budget of the European Centre for the Development of Vocational Training for the financial year 2009#Resolution of the European Parliament of 10 May 2011 with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget for the European Centre for the Development of Vocational Training for the financial year 2009

text:
               27.9.2011

               EN

               Official Journal of the European Union

               L 250/130

         DECISION OF THE EUROPEAN PARLIAMENT
   of 10 May 2011
   on discharge in respect of the implementation of the budget of the European Centre for the Development of Vocational Training for the financial year 2009
   (2011/568/EU)
   THE EUROPEAN PARLIAMENT,

               —

               having regard to the final annual accounts of the European Centre for the Development of Vocational Training for the financial year 2009,

               —

               having regard to the Court of Auditors’ report on the annual accounts of the European Centre for the Development of Vocational Training for the financial year 2009, together with the Centre’s replies (1),

               —

               having regard to the Council’s recommendation of 15 February 2011 (05892/2011 — C7-0052/2011),

               —

               having regard to Article 276 of the EC Treaty and Article 319 of the Treaty on the Functioning of the European Union,

               —

               having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Article 185 thereof,

               —

               having regard to Regulation (EEC) No 337/75 of the Council of 10 February 1975 establishing a European Centre for the Development of Vocational Training (3), and in particular Article 12a thereof,

               —

               having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (4), and in particular Article 94 thereof,

               —

               having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,

               —

               having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on Employment and Social Affairs (A7-0106/2011),

               1.

               Grants the Director of the European Centre for the Development of Vocational Training discharge in respect of the implementation of the Centre’s budget for the financial year 2009;

               2.

               Sets out its observations in the resolution below;

               3.

               Instructs its President to forward this Decision and the resolution that forms an integral part of it to the Director of the European Centre for the Development of Vocational Training, the Council, the Commission and the Court of Auditors, and to arrange for their publication in the Official Journal of the European Union (L series).

            The President

         Jerzy BUZEK

            The Secretary-General

         Klaus WELLE

      (1)  OJ C 338, 14.12.2010, p. 130.

      (2)  OJ L 248, 16.9.2002, p. 1.

      (3)  OJ L 39, 13.2.1975, p. 1.

      (4)  OJ L 357, 31.12.2002, p. 72.

      RESOLUTION OF THE EUROPEAN PARLIAMENT
      of 10 May 2011
      with observations forming an integral part of its Decision on discharge in respect of the implementation of the budget for the European Centre for the Development of Vocational Training for the financial year 2009
      THE EUROPEAN PARLIAMENT,

                  —

                  having regard to the final annual accounts of the European Centre for the Development of Vocational Training for the financial year 2009,

                  —

                  having regard to the Court of Auditors’ report on the annual accounts of the European Centre for the Development of Vocational Training for the financial year 2009, together with the Centre’s replies (1),

                  —

                  having regard to the Council’s recommendation of 15 February 2011 (05892/2011 — C7-0052/2011),

                  —

                  having regard to Article 276 of the EC Treaty and Article 319 of the Treaty on the Functioning of the European Union,

                  —

                  having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (2), and in particular Article 185 thereof,

                  —

                  having regard to Regulation (EEC) No 337/75 of the Council of 10 February 1975 establishing a European Centre for the Development of Vocational Training (3), and in particular Article 12a thereof,

                  —

                  having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (4), and in particular Article 94 thereof,

                  —

                  having regard to Rule 77 of, and Annex VI to, its Rules of Procedure,

                  —

                  having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on Employment and Social Affairs (A7-0106/2011),

                  A.

                  whereas the Court of Auditors stated that it has obtained reasonable assurances that the annual accounts for the financial year 2009 are reliable and that the underlying transactions are legal and regular,

                  B.

                  whereas on 5 May 2010 Parliament granted discharge to the Director of the European Centre for the Development of Vocational Training for implementation of the Centre’s budget for the financial year 2008 (5), and in its resolution accompanying the discharge decision, inter alia:

                              —

                              drew attention to the fact that the Centre once again carried forward appropriations (which was 25 % of payment appropriations, or EUR 1 400 000),

                              —

                              pointed out that this revealed weaknesses in the programming and monitoring of differentiated appropriations for operating activities,

                  C.

                  whereas the budget of the Centre for 2009 was EUR 18 530 000, which is an increase of 1 % on the financial year 2008,

         Performance

                  1.

                  Draws attention to the Court of Auditors’ confirmation that the annual accounts in respect of a budget of EUR 18 500 000 fairly present the Centre’s actual financial position as at 31 December 2009 and that the Centre’s operations and cash flows for the financial year 2009 are in accordance with its financial rules;

                  2.

                  Expresses its satisfaction that the Court of Auditors has declared the operations underlying the Centre’s annual accounts for the financial year 2009 to be legal and regular; welcomes the Centre’s intention to make available in respect of 2011 Gantt charts for all key operational activities; reminds the Centre that these charts outline, in a concise way, the amount of time spent by each staff member on a project and encourage an approach geared towards achieving results;

                  3.

                  Congratulates the Centre for introducing a performance measurement system (PMS) in 2009 in respect of its medium term priorities 2009-2011 and its annual work programme, and for having set up a framework of performance indicators to monitor progress and measure output, outcome and impact; considers, in particular, that the introduction of a PMS helps the Centre manage and evaluate its impact, efficiency, effectiveness and relevance; believes, furthermore, that this system could include further improvements to the activity-based budget and closer monitoring of payment appropriations to avoid carry-overs;

                  4.

                  Calls on the Centre to set out, in a table to be annexed to the Court of Auditors’ next report, a clear comparison of the operations that were carried out during the year for which discharge is to be granted and during the previous financial year, so as to enable the discharge authority to assess more effectively its performance from one year to the next;

                  5.

                  Is interested in the activities of the Centre with Norway and Iceland and notes that it has introduced a plan to align the use of the contributions of Norway and Iceland with the use of the Union subsidy which should be implemented by 2013;

         Human resources

                  6.

                  Notes that the Centre has introduced changes in its recruitment procedures following remarks by the Court of Auditors in its 2009 report calling on the Centre to further improve transparency; welcomes, the Centre’s initiative, since June 2010, in respect of questions in written tests and interviews before pre-selection;

         Carry-over appropriations

                  7.

                  Draws attention to the fact that the Centre has carried appropriations forward (31 % of the administrative expenditure — Title II) and cancelled payment appropriations (24 % of total appropriations for operating activities); calls, accordingly, on the Centre to continue to improve the programming and monitoring and to respect the principle of annuality more fully;

         Budget management

                  8.

                  Calls on the Centre to apply more effectively the budgetary principles of specification and transparency; acknowledges that in June 2010 the Centre informed the Governing Board on all 2009 and 2010 transfers and since then has continuously informed the Governing Board on transfers and has clarified the 10 % rule in its new implementing rules to the financial rules which were adopted by the Governing Board in December 2010;

         Internal audit

                  9.

                  Acknowledges that the Centre has sent to the authority responsible for discharge a report drawn up by its Director summarising the content of the Internal Audit Service (IAS)’s recommendation, as provided for in Article 72(5) of the framework Financial Regulation; nevertheless, calls on the Director of the Centre to provide specific information on the content of the 15 recommendations opened on 31 December 2008 and the new 14 recommendations opened on 31 December 2009, in both cases by the IAS;

                  10.

                  Welcomes the Centre’s establishment of an online procurement tool in 2009 with the purpose of improving planning and monitoring of the annual procurement plan;

                  11.

                  Notes that the Centre finalised in 2009 an updated procedure for decommitments in order to further improve the transparency of the inventory of assets; notes, in addition, that, in the same year, the Centre started to document the main control processes; calls, accordingly, on the Centre to inform the discharge authority of the steps taken in this regard;

                  12.

                  Welcomes the fact that the Centre is the first Agency that voluntarily undertook a pilot audit on the ethical framework in 2009;

                  13.

                  Refers, in respect of the other observations accompanying its Decision on discharge, which are of a horizontal nature, to its resolution of 10 May 2011 (6) on the performance, financial management and control of the agencies.

         (1)  OJ C 338, 14.12.2010, p. 130.

         (2)  OJ L 248, 16.9.2002, p. 1.

         (3)  OJ L 39, 13.2.1975, p. 1.

         (4)  OJ L 357, 31.12.2002, p. 72.

         (5)  OJ L 252, 25.9.2010, p. 124.

         (6)  Texts adopted, P7_TA(2011)0163 (See page 269 of this Official Journal).