# L_2008187EN.01012801.xml

| 15.7.2008 | EN | Official Journal of the European Union | L 187/128 |
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15.7.2008

EN

Official Journal of the European Union

L 187/128

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DECISION OF THE EUROPEAN PARLIAMENT

DECISION OF THE EUROPEAN PARLIAMENT

of 24 April 2007

on the discharge for the implementation of the budget of the European Medicines Agency for the financial year 2005

(2008/521/EC)

THE EUROPEAN PARLIAMENT,

having regard to the final annual accounts of the European Medicines Agency for the financial year 2005 (1),

1

having regard to the Court of Auditors' report on the final annual accounts of the European Medicines Agency for the financial year 2005, together with the Agency's replies (2),

2

having regard to the Council's Recommendation of 27 February 2007 (5711/2007 — C6-0080/2007),

having regard to the EC Treaty, and in particular Article 276 thereof,

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,

3

having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (4), and in particular Article 68 thereof,

4

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 (5), and in particular Article 94 thereof,

5

having regard to Rule 71 of and Annex V 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 (A6-0099/2007),

| 1. | Grants the executive director of the European Medicines Agency discharge for the implementation of the Agency's budget for the financial year 2005; |
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1.

Grants the executive director of the European Medicines Agency discharge for the implementation of the Agency's budget for the financial year 2005;

| 2. | Sets out its observations in the Resolution below; |
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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). |
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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).

Official Journal of the European Union

The President

Hans-Gert PÖTTERING

The Secretary-General

Harald RØMER

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(1)  OJ C 266, 31.10.2006, p. 4.

1

(2)  OJ C 312, 19.12.2006, p. 12.

2

(3)  OJ L 248, 16.9.2002, p. 1. Regulation as amended by Regulation (EC, Euratom) No 1995/2006 (OJ L 390, 30.12.2006, p. 1).

3

(4)  OJ L 136, 30.4.2004, p. 1. Regulation as amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).

4

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

5

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RESOLUTION OF THE EUROPEAN PARLIAMENT

of 24 April 2007

with observations forming an integral part of the Decision on the discharge for the implementation of the budget of the European Medicines Agency for the financial year 2005

THE EUROPEAN PARLIAMENT,

having regard to the final annual accounts of the European Medicines Agency for the financial year 2005 (1),

having regard to the Court of Auditors' report on the final annual accounts of the European Medicines Agency for the financial year 2005, together with the Agency's replies (2),

having regard to the Council's Recommendation of 27 February 2007 (5711/2007 — C6-0080/2007),

having regard to the EC Treaty, and in particular Article 276 thereof,

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 of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (4), 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 (5), and in particular Article 94 thereof,

having regard to Rule 71 of and Annex V 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 (A6-0099/2007),

| A. | whereas the Court of Auditors stated that it obtained reasonable assurance that the annual accounts for the financial year ended 31 December 2005 were reliable and that the underlying transactions, taken as a whole, were legal and regular; |
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A.

whereas the Court of Auditors stated that it obtained reasonable assurance that the annual accounts for the financial year ended 31 December 2005 were reliable and that the underlying transactions, taken as a whole, were legal and regular;

| B. | whereas on 27 April 2006 Parliament gave discharge to the director in respect of the implementation of the Agency's budget for the 2004 financial year (6) and in the Resolution accompanying the discharge decision Parliament, inter alia,







  — | noted the Court of Auditor's finding that contracts concluded with banks had been in force for over five years, in contravention of the Agency's financial regulation implementing rules, which require a new invitation to tender at least every five years; noted the Agency's reply, explaining the reasons for the delay in launching a call for tendering, and setting out the benefits achieved through direct negotiation with the bank, and will bear this in mind when considering revisions to the Financial Regulation, |
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B.

whereas on 27 April 2006 Parliament gave discharge to the director in respect of the implementation of the Agency's budget for the 2004 financial year (6) and in the Resolution accompanying the discharge decision Parliament, inter alia,

—

noted the Court of Auditor's finding that contracts concluded with banks had been in force for over five years, in contravention of the Agency's financial regulation implementing rules, which require a new invitation to tender at least every five years; noted the Agency's reply, explaining the reasons for the delay in launching a call for tendering, and setting out the benefits achieved through direct negotiation with the bank, and will bear this in mind when considering revisions to the Financial Regulation,

| — | pointed out that the new pharmaceuticals legislation, which was adopted in 2004, had a considerable impact on the Agency's work and management structures; |
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pointed out that the new pharmaceuticals legislation, which was adopted in 2004, had a considerable impact on the Agency's work and management structures;

General points concerning the majority of EU Agencies requiring individual discharge

| 1. | Considers that the ever-growing number of Community Agencies and the activities of certain of them do not seem to form part of an overall policy framework, and that the remits of some Agencies do not always reflect the real needs of the Union or the expectations of its citizens, and notes that in general terms the Agencies do not always have a good image or a good press; |
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1.

Considers that the ever-growing number of Community Agencies and the activities of certain of them do not seem to form part of an overall policy framework, and that the remits of some Agencies do not always reflect the real needs of the Union or the expectations of its citizens, and notes that in general terms the Agencies do not always have a good image or a good press;

| 2. | Invites the Commission therefore to define an overall policy framework for the setting up of new Community Agencies and to present a cost-benefit study before the setting up of any new Agency, while being careful to avoid any overlap of activities between Agencies or with the remits of other European organisations; |
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2.

Invites the Commission therefore to define an overall policy framework for the setting up of new Community Agencies and to present a cost-benefit study before the setting up of any new Agency, while being careful to avoid any overlap of activities between Agencies or with the remits of other European organisations;

| 3. | Calls on the Court of Auditors to give its opinion on the cost-benefit study before Parliament takes its decision; |
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3.

Calls on the Court of Auditors to give its opinion on the cost-benefit study before Parliament takes its decision;

| 4. | Invites the Commission to present every five years a study on the added value of every existing Agency; invites all relevant institutions in the case of a negative evaluation of the added value of an Agency to take the necessary steps by reformulating the mandate of that Agency or by closing it; |
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4.

Invites the Commission to present every five years a study on the added value of every existing Agency; invites all relevant institutions in the case of a negative evaluation of the added value of an Agency to take the necessary steps by reformulating the mandate of that Agency or by closing it;

| 5. | Considers it regrettable, given the growing number of regulatory Agencies, that the negotiations on the draft interinstitutional agreement on the operating framework for the European regulatory Agencies have not yet been concluded, and calls on the relevant departments of the Commission, in consultation with the Court of Auditors, to do their utmost to ensure that the agreement is brought to a rapid conclusion; |
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5.

Considers it regrettable, given the growing number of regulatory Agencies, that the negotiations on the draft interinstitutional agreement on the operating framework for the European regulatory Agencies have not yet been concluded, and calls on the relevant departments of the Commission, in consultation with the Court of Auditors, to do their utmost to ensure that the agreement is brought to a rapid conclusion;

| 6. | Notes that the Commission's budgetary responsibility calls for closer linking of the Agencies to the Commission; calls on the Commission and the Council to take all necessary steps to give the Commission a blocking minority in the supervisory bodies of the regulatory Agencies by 31 December 2007 and to provide for such a minority from the outset when new Agencies are set up; |
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6.

Notes that the Commission's budgetary responsibility calls for closer linking of the Agencies to the Commission; calls on the Commission and the Council to take all necessary steps to give the Commission a blocking minority in the supervisory bodies of the regulatory Agencies by 31 December 2007 and to provide for such a minority from the outset when new Agencies are set up;

| 7. | Invites the Court of Auditors to create an additional chapter in its Annual Report, devoted to all Agencies to be discharged under the Commission's accounts in order to have a much clearer picture of the use of EU funds by Agencies; |
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7.

Invites the Court of Auditors to create an additional chapter in its Annual Report, devoted to all Agencies to be discharged under the Commission's accounts in order to have a much clearer picture of the use of EU funds by Agencies;

| 8. | Recalls the principle according to which all Community Agencies, whether subsidised or not, are subject to discharge by the Parliament, even where a discharge authority exists by virtue of their constitutive texts; |
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8.

Recalls the principle according to which all Community Agencies, whether subsidised or not, are subject to discharge by the Parliament, even where a discharge authority exists by virtue of their constitutive texts;

| 9. | Calls on the Court of Auditors to perform performance audits for all Agencies and to report back to the relevant committees of Parliament, including the Committee on Budgetary Control; |
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9.

Calls on the Court of Auditors to perform performance audits for all Agencies and to report back to the relevant committees of Parliament, including the Committee on Budgetary Control;

| 10. | Notes that the number of Agencies is constantly increasing and that, in accordance with the Commission's political responsibility for the operation of the Agencies, which goes far beyond mere logistical support, there is an even higher need for the Directorates-General of the Commission charged with the setting up and monitoring of Agencies to develop a common approach to the Agencies; considers that a structure similar to the one created by the Agencies for coordination among the DGs concerned would be a pragmatic way forward towards a common approach by the Commission on all matters relating to the Agencies; |
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10.

Notes that the number of Agencies is constantly increasing and that, in accordance with the Commission's political responsibility for the operation of the Agencies, which goes far beyond mere logistical support, there is an even higher need for the Directorates-General of the Commission charged with the setting up and monitoring of Agencies to develop a common approach to the Agencies; considers that a structure similar to the one created by the Agencies for coordination among the DGs concerned would be a pragmatic way forward towards a common approach by the Commission on all matters relating to the Agencies;

| 11. | Invites the Commission to improve administrative and technical support to the Agencies, taking into account the growing complexity of the Community's administrative rules and technical problems; |
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11.

Invites the Commission to improve administrative and technical support to the Agencies, taking into account the growing complexity of the Community's administrative rules and technical problems;

| 12. | Notes the lack of a disciplinary body in any of the Community Agencies, and calls on the Commission to take the necessary steps to ensure that such a mechanism is rapidly put in place; |
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12.

Notes the lack of a disciplinary body in any of the Community Agencies, and calls on the Commission to take the necessary steps to ensure that such a mechanism is rapidly put in place;

| 13. | Welcomes the considerable improvements in the coordination among the Agencies, which allows them to tackle recurring problems and makes cooperation with the Commission and Parliament more efficient; |
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13.

Welcomes the considerable improvements in the coordination among the Agencies, which allows them to tackle recurring problems and makes cooperation with the Commission and Parliament more efficient;

| 14. | Takes the view that the establishment by a number of Agencies of a shared support service aimed at making their computerised financial management systems consistent with those of the Commission is a measure that should be taken further and extended; |
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14.

Takes the view that the establishment by a number of Agencies of a shared support service aimed at making their computerised financial management systems consistent with those of the Commission is a measure that should be taken further and extended;

| 15. | Calls upon the Agencies to improve their cooperation and benchmarking with actors in the field; urges the Commission and to adopt any measures it considers necessary to help the Agencies enhance their image and raise the profile of their activities; |
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15.

Calls upon the Agencies to improve their cooperation and benchmarking with actors in the field; urges the Commission and to adopt any measures it considers necessary to help the Agencies enhance their image and raise the profile of their activities;

| 16. | Calls upon the Commission to come up with a proposal to harmonise the format of the annual reporting by the Agencies and to develop performance indicators which would allow a comparison of their efficiency; |
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16.

Calls upon the Commission to come up with a proposal to harmonise the format of the annual reporting by the Agencies and to develop performance indicators which would allow a comparison of their efficiency;

| 17. | Invites the Agencies to present at the beginning of every year performance indicators against which they could be measured; |
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17.

Invites the Agencies to present at the beginning of every year performance indicators against which they could be measured;

| 18. | Invites all Agencies to increasingly use SMART objectives which should lead to more realistic planning and implementation of goals; |
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18.

Invites all Agencies to increasingly use SMART objectives which should lead to more realistic planning and implementation of goals;

| 19. | Agrees with the Court of Auditors that the Commission also bears responsibility for the (financial) management of the Agencies; therefore, urges the Commission to monitor and where necessary direct and help the management of the different Agencies, especially in relation to the proper application of tender procedures, transparency of recruitment procedures, sound financial management (underspending and overbudgeting) and most importantly the proper application of the rules concerning the internal control framework; |
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19.

Agrees with the Court of Auditors that the Commission also bears responsibility for the (financial) management of the Agencies; therefore, urges the Commission to monitor and where necessary direct and help the management of the different Agencies, especially in relation to the proper application of tender procedures, transparency of recruitment procedures, sound financial management (underspending and overbudgeting) and most importantly the proper application of the rules concerning the internal control framework;

| 20. | Considers that the Agencies' work programmes should express their contributions in operational and measurable terms and that due consideration should be given to the Commission's Internal Control Standards; |
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20.

Considers that the Agencies' work programmes should express their contributions in operational and measurable terms and that due consideration should be given to the Commission's Internal Control Standards;

Specific points

| 21. | Notes that the implementation of the budget, the utilisation rates for commitment appropriations (94 %) and payment appropriations (82 %) were on the whole high, and that for administrative expenditure (Title II) the utilisation rate for commitment appropriations was less than 90 %, with more than 40 % of the commitments made being carried over to the following financial year; |
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21.

Notes that the implementation of the budget, the utilisation rates for commitment appropriations (94 %) and payment appropriations (82 %) were on the whole high, and that for administrative expenditure (Title II) the utilisation rate for commitment appropriations was less than 90 %, with more than 40 % of the commitments made being carried over to the following financial year;

| 22. | Notes that the budget of the Agency has grown considerably between 2003 and 2005 due to the enlargement of the European Union and new tasks; is very pleased with the increased appropriations for, and the full implementation of, the Orphan Drugs budget line; |
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22.

Notes that the budget of the Agency has grown considerably between 2003 and 2005 due to the enlargement of the European Union and new tasks; is very pleased with the increased appropriations for, and the full implementation of, the Orphan Drugs budget line;

| 23. | Invites the Agency to make sure that only staff members with delegation rights have access to the corresponding computer system; |
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23.

Invites the Agency to make sure that only staff members with delegation rights have access to the corresponding computer system;

| 24. | Invites the Agency to integrate into its accounts the funds (7) collected from other Agencies and bodies to finance a common support service to develop their financial management information systems; |
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24.

Invites the Agency to integrate into its accounts the funds (7) collected from other Agencies and bodies to finance a common support service to develop their financial management information systems;

| 25. | Demands that contract award procedures should be transparent and follow the guiding rules including in the IT area; |
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25.

Demands that contract award procedures should be transparent and follow the guiding rules including in the IT area;

| 26. | Invites the Agency to inform Parliament about the new call for tender concerning bank contracts according to standard rules as soon as possible; |
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26.

Invites the Agency to inform Parliament about the new call for tender concerning bank contracts according to standard rules as soon as possible;

| 27. | Points out that the new pharmaceuticals legislation, which was adopted in 2004, has had a considerable impact on the Agency's work, management structures and staff; congratulates the Agency on successfully adapting to the new regulatory framework, which entered into force in November 2005; |
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27.

Points out that the new pharmaceuticals legislation, which was adopted in 2004, has had a considerable impact on the Agency's work, management structures and staff; congratulates the Agency on successfully adapting to the new regulatory framework, which entered into force in November 2005;

| 28. | Is pleased at the launch of the ‘SME office’, providing financial and administrative assistance to micro, small and medium-sized enterprises (SMEs) pursuant to Commission Regulation (EC) No 2049/2005 (8); |
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28.

Is pleased at the launch of the ‘SME office’, providing financial and administrative assistance to micro, small and medium-sized enterprises (SMEs) pursuant to Commission Regulation (EC) No 2049/2005 (8);

| 29. | Welcomes the efforts of the Agency to provide more scientific advice at 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; notes the work done by the Agency to facilitate a quick assessment of vaccines in the event of an influenza pandemic; |
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29.

Welcomes the efforts of the Agency to provide more scientific advice at 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; notes the work done by the Agency to facilitate a quick assessment of vaccines in the event of an influenza pandemic;

| 30. | Requests that, before 1 January 2010 and every five years thereafter, the Agency commission an independent external evaluation of its achievements on the basis of its founding Regulation and the work programmes decided by the Management Board; requests further that the evaluation assess the working practices and the impact of the Agency and take into account the views of the stakeholders, at both Community and national level; requests that the Management Board of the Agency examine the conclusions of the evaluation and draft such recommendations to the Commission and Parliament as may be necessary regarding changes in the Agency, its working practices and programmes, that the evaluation and the recommendations to the Commission and Parliament shall be made public, for example on their websites, and that the Funds needed to carry out the external evaluation shall be allocated through the budget of the corresponding DG. |
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30.

Requests that, before 1 January 2010 and every five years thereafter, the Agency commission an independent external evaluation of its achievements on the basis of its founding Regulation and the work programmes decided by the Management Board; requests further that the evaluation assess the working practices and the impact of the Agency and take into account the views of the stakeholders, at both Community and national level; requests that the Management Board of the Agency examine the conclusions of the evaluation and draft such recommendations to the Commission and Parliament as may be necessary regarding changes in the Agency, its working practices and programmes, that the evaluation and the recommendations to the Commission and Parliament shall be made public, for example on their websites, and that the Funds needed to carry out the external evaluation shall be allocated through the budget of the corresponding DG.

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(1)  OJ C 266, 31.10.2006, p. 4.

(2)  OJ C 312, 19.12.2006, p. 12.

(3)  OJ L 248, 16.9.2002, p. 1. Regulation as amended by Regulation (EC, Euratom) No 1995/2006 (OJ L 390, 30.12.2006, p. 1).

(4)  OJ L 136, 30.4.2004, p. 1. Regulation as amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).

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

(6)  OJ L 340, 6.12.2006, p. 107.

(7)  Approximately EUR 400 000.

(8)  Commission Regulation (EC) No 2049/2005 of 15 December 2005 laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises. (OJ L 329, 16.12.2005, p. 4).

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