PURPOSE : presentation of the financial statements and the\nbalance sheets for the European Agency for the Evaluation of\nMedicinal Products for the financial year 2003.
\nCONTENT : this report presented by the European Agency for the\nEvaluation of Medicinal Products presents the financial statements\nand balance sheets of its activities in 2003.
\nThe appropriations entered in the final budget amount to EUR\n84.2 million with a Community contribution of 23% (excluding\nsubsidy for orphan medicines).
\nIn terms of the staffing policy, the Agency, whose headquarters\nare in London (UK), officially provided 287 posts. 256 are occupied\nwith + 48 other posts (auxiliary contracts, national experts on\nsecondment, local and temporary staff). Therefore, there are a\ntotal of 304 assigned to operational and administrative duties.
\nIn 2003, the Agency concentrated on the scientific evaluation of\nmedicinal products.
\nAs far as medicinal products for human use are concerned :
\n- Applications for marketing authorisations: 39;
\n- Favourable opinions: 39;
\n- Average evaluation time: 190 days;
\n- Opinions after authorisation: 941;
\n- Pharmacovigilance: 45 538 reports;
\n- Periodic reliability reports: 276;
\n- Monitoring measures: 1 025;
\n- Scientific opinions: 65;
\n- Procedures for mutual recognition: 4 080.
\nOn the issue of Veterinary Medicinal Products:
\n- New applications: 10;
\n- Applications in respect of variants: 64;
\n- Inspection: 76.
\nHaving examined the revenue and expenditure\naccount for the financial year 2003, the balance sheet of revenue\nand expenditure at 31 December 2003 of the European Agency for the\nEvaluation of Medicinal Products and the Court of Auditors' report\non the annual accounts of the Agency, the Council recommends that\nthe European Parliament give a discharge to the Director of the\nAgency in respect of the implementation of the budget for the\nfinancial year 2003.
\nTo\nrecall, EUR 6.0 million (88%)\nof the EUR 6.8 million in appropriations carried forward from the\nfinancial year 2002 to the financial year 2003 have been used. EUR\n16.1 million in appropriations have been carried forward from the\nfinancial year 2003 to the financial year 2004 and EUR 3.3 million\nhave been cancelled.
\nObservations in the\nCourt of Auditors' report in relation to the financial year 2003\ncall for certain comments by the Council, which are annexed to this\nRecommendation.
\nThe Council notes that\nthe Court has been able to issue a statement of reasonable\nassurance on the reliability of the Agency's annual accounts for\nthe financial year 2003. However, it regrets that in respect of the\nreasonable assurance as to the legality and regularity of the\nunderlying transactions, taken as a whole, the Court has excluded\nsome situations concerning tenders and negotiated procedure for\ncontracts.
\nThe Council shares the\nCourt's concerns on the procurement procedures applied by the\nAgency: whereas the general rules provide for a committee for the\nevaluation of tenders to be set up for any contract involving an\namount exceeding EUR 13 800, the Agency sets this threshold at EUR\n75 000.
\nThe Council urges the\nAgency to pursue the reinforcement of the implementing rules on the\naward of contracts in line with the provisions of the general\nFinancial Regulation and its implementing rules. Moreover, in\ncertain negotiated procedures, the choice of supplier was based on\nthe criteria of \"former experience with the contractor\", which is\nnot provided for in the implementing rules for the financial\nregulation.
\nThe Council asks the\nAgency to remedy its shortcomings regarding the criteria of choice\nof contractor. In this context, it notes that the Agency has\naligned its implementing rules with the framework Financial\nRegulation applicable to Agencies and with the Commission's\nimplementing rules.
\nThe Council notes with\nsatisfaction that the Agency has finally set up a new asset\nmanagement system enabling the inventory data of all assets,\ntangible and intangible, to be consistent with the accounting\ndata.
\nEP: decision of committee\nresponsible, 1st reading/single reading
\nThe committee adopted the report by\nInés AYALA SENDER (PES, ES) and Carl SCHLYTER (Greens/EFA,\nSE) giving discharge to the Director of the European Agency for the\nEvaluation of Medicinal Products for the 2003 financial year.
\nIn its accompanying comments, the committee\nmade a number of general points addressed to the Commission, the\nAgencies and the Court of Auditors (ECA):
\n- before the Commission defines the framework\nconditions for the use of regulatory agencies, an\ninterinstitutional agreement should spell out common\nguidelines;
\n- the Commission should carry out a\ncross-cutting analysis, on a standard three-year cycle, of the\ncoherence of agency activity with EU policy in general. It should\nalso assess \"the broader European added value\" of the Agencies'\nwork in their respective fields. Before any decision is taken to\npropose the creation of a new agency, the need for such an agency\nshould be carefully evaluated, bearing in mind existing structures\nand the principles of subsidiarity, budgetary austerity and\nsimplification of procedures;
\n- the Agencies were urged to comply fully with\nthe budgetary principles set out in the Financial Regulation,\nfurther strengthen their internal management and control procedures\nand pay \"special attention\" to procedures for the award and\nmanagement of contracts. They should also step up cooperation with\neach other, avoid duplication of work and develop a comprehensive\nstrategy for making the results of their work available to the\ngeneral public;
\n- the ECA and the\nAgencies were urged to strengthen their cooperation and establish a\nmethodology \"that prepares the ground for a positive budget\ndischarge from the start of the process\".
\n \n\n\n \n\t\t \t\t\t \t\t\tThe European Parliament adopted a resolution drafted by co-rapporteurs\nInés AYALA SENDER (PES, ES) and Carl SCHLYTER (Greens/EFA,\nSE) giving discharge to the Executive\nDirector of the European Agency for the Evaluation of Medicinal\nProductsin respect of the implementation\nof its budget for the financial year 2003. (Please see the summary of 16/03/05.)
\nParliament's resolution is in two parts: the first\nconcerns the discharge itself and the second part deals with an\naccompanying resolution on the management and implementation of the\nbudget. The accompanying resolution also carries general points addressed to the Commission and the\nAgencies.
\nParliament noted the Agency's efforts in 2004 aimed at\nstrengthening its inventory system and the fact that all its assets\nare now entered in the new management system in compliance with the\nCommission's harmonised accounting plan. It stated that the Agency\nmust build on measures already taken in order to respond to the\nCourt of Auditors observation as regards the application of\nnegotiated procedures in procurement.
\nIt also asked the Agency and national authorities to\ncomplete work the European-wide pharmacovigilance reporting system\n(EudraVigilance database), which is still not fully\noperational.
\nWhilst Parliament welcomed the Agency's equal\nopportunities commitment, it regretted the absence of an equality\nplan. Parliament noted that the EMEA is the only Agency with more\nwomen than men in grade A.
\nFinally, Parliament commended the Agency's commitment\nto transparency and measures taken to improve its strategy for\ninformation and communication to patients and health\nprofessionals.
\nParliament went on to make some general observations\ncommon to all the agencies. The principal points may be summarized\nas follows:
\nGeneral points addressed to the Commission and the\nAgencies: Parliament supported the Commission's efforts to establish a\nlimited number of models, at least for future 'regulatory'\nagencies. It took the view that the structure of current and future\nagencies merited in-depth consideration at inter-institutional\nlevel. Before the Commission defines the framework conditions for\nthe use of regulatory agencies, an inter-institutional agreement\nshould spell out common guidelines. Parliament invited the\nCommission to perform by the end of 2005 a cross-cutting analysis\nof the evaluations carried out on individual Agencies in order\nto:
\n- reach conclusions with regard to the coherence of\nAgency activity with EU policies in general and as regards the\nsynergies existing or to be developed between the agencies and\nCommission departments and the avoidance of overlapping between\nthem;
\n- make an assessment of the broader European added\nvalue of the Agencies' outputs in their respective area of activity\nand of the relevance and effectiveness of the Agency model in\nimplementing or contributing to EU policies;
\n- determine the impact of the Agencies' actions in\nterms of the proximity and visibility of the EU to its\ncitizens.
\nIn parallel with this exercise, the Commission should\npresent proposals for changes to be made in the existing Agencies'\nConstituent Acts with a view to optimising its relationship with\nthe Agencies. Before any decision is taken to propose the creation\nof a new agency, the Commission must undertake a strict evaluation\nof the added value of the function of this agency, bearing in mind\nexisting structures, the principles of subsidiarity, budgetary\nausterity and the simplification of procedures.
\nGeneral points addressed to the Agencies:
\nParliament wanted to receive from each of the Agencies, the report summarizing\ninformation on the audits carried out by the Internal Auditor, the\nrecommendations made and the action taken on these recommendations\nin accordance with Regulation 2343/2002/EC. Agencies should also\nmake further efforts to apply correctly the staff regulations and\nrules applicable to other civil servants with regard to their\nstaff. Parliament made some remarks on the imbalance between men\nand women in high-grade positions in the agencies, and stated that\nrelevant provisions on equal opportunities must be\nobserved.
\nIn response to the relevant observations of the Court\nof Auditors, the Agencies must comply fully with the budgetary\nprinciples as set out in the Financial Regulation, in particular\nthose of unity and budgetary accuracy.
\nParliament went on to encourage the Agencies to\nstrengthen their co-operation, thus opening up opportunities for\ndeveloping synergies, and avoiding duplication of work. Parliament\nexpected to be informed regularly on this issue.
\nIt called on the Agencies to pay special attention to\nprocedures for the award and management of contracts, and to\nstrengthen their internal control procedures. Parliament\nsuggested the setting-up of specialised units entrusted with the\ntask of advising, on the basis of risk analysis, on how best to\nprepare contract award procedures.
\nGeneral points addressed to the European Court of\nAuditors and the Agencies:
\nParliament asked Court of Auditors and the Agencies to\nstrengthen their co-operation in order to enhance the procedures\nand technical tools to improve the sound management of all the\nbudgetary and finance issues. They should do this in order to\nestablish a methodology that prepares the ground for a positive\nbudget discharge from the start of the process.
\nOBJECTIVE: granting of discharge for implementing the EU's\ngeneral budget for 2003 - European Medicines Agency.
\nLEGISLATIVE ACT:\nDecision 2005/543/EC of the European Parliament concerning the\ndischarge for implementing the general budget of the EU for the\n2003 financial year - European Medicines Agency.
\nCONTENT: With this Decision, the European\nParliament grants discharge to the Director of the European\nMedicines Agency for the implementation of the budget for the 2003\nfinancial year.
\nThis decision is in line with the European\nParliament's resolution adopted on 12 April 2005 and comprises a\nseries of observations that form an integral part of the discharge\ndecision (please refer to the summary of the opinion of\n12/04/2005).
\nPURPOSE : presentation of the financial statements and the\nbalance sheets for the European Agency for the Evaluation of\nMedicinal Products for the financial year 2003.
\nCONTENT : this report presented by the European Agency for the\nEvaluation of Medicinal Products presents the financial statements\nand balance sheets of its activities in 2003.
\nThe appropriations entered in the final budget amount to EUR\n84.2 million with a Community contribution of 23% (excluding\nsubsidy for orphan medicines).
\nIn terms of the staffing policy, the Agency, whose headquarters\nare in London (UK), officially provided 287 posts. 256 are occupied\nwith + 48 other posts (auxiliary contracts, national experts on\nsecondment, local and temporary staff). Therefore, there are a\ntotal of 304 assigned to operational and administrative duties.
\nIn 2003, the Agency concentrated on the scientific evaluation of\nmedicinal products.
\nAs far as medicinal products for human use are concerned :
\n- Applications for marketing authorisations: 39;
\n- Favourable opinions: 39;
\n- Average evaluation time: 190 days;
\n- Opinions after authorisation: 941;
\n- Pharmacovigilance: 45 538 reports;
\n- Periodic reliability reports: 276;
\n- Monitoring measures: 1 025;
\n- Scientific opinions: 65;
\n- Procedures for mutual recognition: 4 080.
\nOn the issue of Veterinary Medicinal Products:
\n- New applications: 10;
\n- Applications in respect of variants: 64;
\n- Inspection: 76.
\nHaving examined the revenue and expenditure\naccount for the financial year 2003, the balance sheet of revenue\nand expenditure at 31 December 2003 of the European Agency for the\nEvaluation of Medicinal Products and the Court of Auditors' report\non the annual accounts of the Agency, the Council recommends that\nthe European Parliament give a discharge to the Director of the\nAgency in respect of the implementation of the budget for the\nfinancial year 2003.
\nTo\nrecall, EUR 6.0 million (88%)\nof the EUR 6.8 million in appropriations carried forward from the\nfinancial year 2002 to the financial year 2003 have been used. EUR\n16.1 million in appropriations have been carried forward from the\nfinancial year 2003 to the financial year 2004 and EUR 3.3 million\nhave been cancelled.
\nObservations in the\nCourt of Auditors' report in relation to the financial year 2003\ncall for certain comments by the Council, which are annexed to this\nRecommendation.
\nThe Council notes that\nthe Court has been able to issue a statement of reasonable\nassurance on the reliability of the Agency's annual accounts for\nthe financial year 2003. However, it regrets that in respect of the\nreasonable assurance as to the legality and regularity of the\nunderlying transactions, taken as a whole, the Court has excluded\nsome situations concerning tenders and negotiated procedure for\ncontracts.
\nThe Council shares the\nCourt's concerns on the procurement procedures applied by the\nAgency: whereas the general rules provide for a committee for the\nevaluation of tenders to be set up for any contract involving an\namount exceeding EUR 13 800, the Agency sets this threshold at EUR\n75 000.
\nThe Council urges the\nAgency to pursue the reinforcement of the implementing rules on the\naward of contracts in line with the provisions of the general\nFinancial Regulation and its implementing rules. Moreover, in\ncertain negotiated procedures, the choice of supplier was based on\nthe criteria of \"former experience with the contractor\", which is\nnot provided for in the implementing rules for the financial\nregulation.
\nThe Council asks the\nAgency to remedy its shortcomings regarding the criteria of choice\nof contractor. In this context, it notes that the Agency has\naligned its implementing rules with the framework Financial\nRegulation applicable to Agencies and with the Commission's\nimplementing rules.
\nThe Council notes with\nsatisfaction that the Agency has finally set up a new asset\nmanagement system enabling the inventory data of all assets,\ntangible and intangible, to be consistent with the accounting\ndata.
\nEP: decision of committee\nresponsible, 1st reading/single reading
\nThe committee adopted the report by\nInés AYALA SENDER (PES, ES) and Carl SCHLYTER (Greens/EFA,\nSE) giving discharge to the Director of the European Agency for the\nEvaluation of Medicinal Products for the 2003 financial year.
\nIn its accompanying comments, the committee\nmade a number of general points addressed to the Commission, the\nAgencies and the Court of Auditors (ECA):
\n- before the Commission defines the framework\nconditions for the use of regulatory agencies, an\ninterinstitutional agreement should spell out common\nguidelines;
\n- the Commission should carry out a\ncross-cutting analysis, on a standard three-year cycle, of the\ncoherence of agency activity with EU policy in general. It should\nalso assess \"the broader European added value\" of the Agencies'\nwork in their respective fields. Before any decision is taken to\npropose the creation of a new agency, the need for such an agency\nshould be carefully evaluated, bearing in mind existing structures\nand the principles of subsidiarity, budgetary austerity and\nsimplification of procedures;
\n- the Agencies were urged to comply fully with\nthe budgetary principles set out in the Financial Regulation,\nfurther strengthen their internal management and control procedures\nand pay \"special attention\" to procedures for the award and\nmanagement of contracts. They should also step up cooperation with\neach other, avoid duplication of work and develop a comprehensive\nstrategy for making the results of their work available to the\ngeneral public;
\n- the ECA and the\nAgencies were urged to strengthen their cooperation and establish a\nmethodology \"that prepares the ground for a positive budget\ndischarge from the start of the process\".
\n \n\n\n \n\t\t \t\t\t \t\t\tThe European Parliament adopted a resolution drafted by co-rapporteurs\nInés AYALA SENDER (PES, ES) and Carl SCHLYTER (Greens/EFA,\nSE) giving discharge to the Executive\nDirector of the European Agency for the Evaluation of Medicinal\nProductsin respect of the implementation\nof its budget for the financial year 2003. (Please see the summary of 16/03/05.)
\nParliament's resolution is in two parts: the first\nconcerns the discharge itself and the second part deals with an\naccompanying resolution on the management and implementation of the\nbudget. The accompanying resolution also carries general points addressed to the Commission and the\nAgencies.
\nParliament noted the Agency's efforts in 2004 aimed at\nstrengthening its inventory system and the fact that all its assets\nare now entered in the new management system in compliance with the\nCommission's harmonised accounting plan. It stated that the Agency\nmust build on measures already taken in order to respond to the\nCourt of Auditors observation as regards the application of\nnegotiated procedures in procurement.
\nIt also asked the Agency and national authorities to\ncomplete work the European-wide pharmacovigilance reporting system\n(EudraVigilance database), which is still not fully\noperational.
\nWhilst Parliament welcomed the Agency's equal\nopportunities commitment, it regretted the absence of an equality\nplan. Parliament noted that the EMEA is the only Agency with more\nwomen than men in grade A.
\nFinally, Parliament commended the Agency's commitment\nto transparency and measures taken to improve its strategy for\ninformation and communication to patients and health\nprofessionals.
\nParliament went on to make some general observations\ncommon to all the agencies. The principal points may be summarized\nas follows:
\nGeneral points addressed to the Commission and the\nAgencies: Parliament supported the Commission's efforts to establish a\nlimited number of models, at least for future 'regulatory'\nagencies. It took the view that the structure of current and future\nagencies merited in-depth consideration at inter-institutional\nlevel. Before the Commission defines the framework conditions for\nthe use of regulatory agencies, an inter-institutional agreement\nshould spell out common guidelines. Parliament invited the\nCommission to perform by the end of 2005 a cross-cutting analysis\nof the evaluations carried out on individual Agencies in order\nto:
\n- reach conclusions with regard to the coherence of\nAgency activity with EU policies in general and as regards the\nsynergies existing or to be developed between the agencies and\nCommission departments and the avoidance of overlapping between\nthem;
\n- make an assessment of the broader European added\nvalue of the Agencies' outputs in their respective area of activity\nand of the relevance and effectiveness of the Agency model in\nimplementing or contributing to EU policies;
\n- determine the impact of the Agencies' actions in\nterms of the proximity and visibility of the EU to its\ncitizens.
\nIn parallel with this exercise, the Commission should\npresent proposals for changes to be made in the existing Agencies'\nConstituent Acts with a view to optimising its relationship with\nthe Agencies. Before any decision is taken to propose the creation\nof a new agency, the Commission must undertake a strict evaluation\nof the added value of the function of this agency, bearing in mind\nexisting structures, the principles of subsidiarity, budgetary\nausterity and the simplification of procedures.
\nGeneral points addressed to the Agencies:
\nParliament wanted to receive from each of the Agencies, the report summarizing\ninformation on the audits carried out by the Internal Auditor, the\nrecommendations made and the action taken on these recommendations\nin accordance with Regulation 2343/2002/EC. Agencies should also\nmake further efforts to apply correctly the staff regulations and\nrules applicable to other civil servants with regard to their\nstaff. Parliament made some remarks on the imbalance between men\nand women in high-grade positions in the agencies, and stated that\nrelevant provisions on equal opportunities must be\nobserved.
\nIn response to the relevant observations of the Court\nof Auditors, the Agencies must comply fully with the budgetary\nprinciples as set out in the Financial Regulation, in particular\nthose of unity and budgetary accuracy.
\nParliament went on to encourage the Agencies to\nstrengthen their co-operation, thus opening up opportunities for\ndeveloping synergies, and avoiding duplication of work. Parliament\nexpected to be informed regularly on this issue.
\nIt called on the Agencies to pay special attention to\nprocedures for the award and management of contracts, and to\nstrengthen their internal control procedures. Parliament\nsuggested the setting-up of specialised units entrusted with the\ntask of advising, on the basis of risk analysis, on how best to\nprepare contract award procedures.
\nGeneral points addressed to the European Court of\nAuditors and the Agencies:
\nParliament asked Court of Auditors and the Agencies to\nstrengthen their co-operation in order to enhance the procedures\nand technical tools to improve the sound management of all the\nbudgetary and finance issues. They should do this in order to\nestablish a methodology that prepares the ground for a positive\nbudget discharge from the start of the process.
\nOBJECTIVE: granting of discharge for implementing the EU's\ngeneral budget for 2003 - European Medicines Agency.
\nLEGISLATIVE ACT:\nDecision 2005/543/EC of the European Parliament concerning the\ndischarge for implementing the general budget of the EU for the\n2003 financial year - European Medicines Agency.
\nCONTENT: With this Decision, the European\nParliament grants discharge to the Director of the European\nMedicines Agency for the implementation of the budget for the 2003\nfinancial year.
\nThis decision is in line with the European\nParliament's resolution adopted on 12 April 2005 and comprises a\nseries of observations that form an integral part of the discharge\ndecision (please refer to the summary of the opinion of\n12/04/2005).
\n