# L_2009255EN.01011701.xml

| 26.9.2009 | EN | Official Journal of the European Union | L 255/117 |
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26.9.2009

EN

Official Journal of the European Union

L 255/117

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DECISION OF THE EUROPEAN PARLIAMENT

DECISION OF THE EUROPEAN PARLIAMENT

of 23 April 2009

on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2007

(2009/645/EC)

THE EUROPEAN PARLIAMENT,

| — | having regard to the final annual accounts of the European Medicines Agency for the financial year 2007 (1), |
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—

having regard to the final annual accounts of the European Medicines Agency for the financial year 2007 (1),

1

| — | having regard to the Court of Auditors’ report on the final annual accounts of the European Medicines Agency for the financial year 2007, together with the Agency’s replies (2), |
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—

having regard to the Court of Auditors’ report on the final annual accounts of the European Medicines Agency for the financial year 2007, together with the Agency’s replies (2),

2

| — | having regard to the Council’s recommendation of 10 February 2009 (5588/2009 — C6-0060/2009), |
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—

having regard to the Council’s recommendation of 10 February 2009 (5588/2009 — C6-0060/2009),

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

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, |
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—

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, |
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—

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 Regulation (EC, Euratom) No 1605/2002 (5), and in particular Article 94 thereof, |
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—

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 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, |
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—

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 (A6-0162/2009), |
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—

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 (A6-0162/2009),

| 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 2007; |
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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 2007;

| 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

Klaus WELLE

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(1)  OJ C 278, 31.10.2008, p. 10.

1

(2)  OJ C 311, 5.12.2008, p. 27.

2

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

3

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

4

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

5

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RESOLUTION OF THE EUROPEAN PARLIAMENT

of 23 April 2009

with observations forming an integral part of the Decision on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2007

THE EUROPEAN PARLIAMENT,

| — | having regard to the final annual accounts of the European Medicines Agency for the financial year 2007 (1), |
| --- | --- |

—

having regard to the final annual accounts of the European Medicines Agency for the financial year 2007 (1),

| — | having regard to the Court of Auditors’ report on the final annual accounts of the European Medicines Agency for the financial year 2007, together with the Agency’s replies (2), |
| --- | --- |

—

having regard to the Court of Auditors’ report on the final annual accounts of the European Medicines Agency for the financial year 2007, together with the Agency’s replies (2),

| — | having regard to the Council’s recommendation of 10 February 2009 (5588/2009 — C6-0060/2009), |
| --- | --- |

—

having regard to the Council’s recommendation of 10 February 2009 (5588/2009 — C6-0060/2009),

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

—

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 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 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 Regulation (EC, Euratom) No 1605/2002 (5), and in particular Article 94 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 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 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 (A6-0162/2009), |
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—

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 (A6-0162/2009),

| A. | whereas the European Court of Auditors (ECA) stated that it has obtained reasonable assurance that the annual accounts for the financial year 2007 are reliable, and the underlying transactions are legal and regular, |
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A.

whereas the European Court of Auditors (ECA) stated that it has obtained reasonable assurance that the annual accounts for the financial year 2007 are reliable, and the underlying transactions are legal and regular,

| B. | whereas on 22 April 2008 Parliament granted the Executive Director of the European Medicines Agency discharge in respect of the implementation of the Agency’s budget for the financial year 2006 (6), and in its resolution accompanying the discharge decision, inter alia:






  — | noted the ECA’s statement in its 2006 report that as regards administrative expenditure the utilisation for commitment appropriations was less than 60 %, |
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B.

whereas on 22 April 2008 Parliament granted the Executive Director of the European Medicines Agency discharge in respect of the implementation of the Agency’s budget for the financial year 2006 (6), and in its resolution accompanying the discharge decision, inter alia:

—

noted the ECA’s statement in its 2006 report that as regards administrative expenditure the utilisation for commitment appropriations was less than 60 %,

| — | noted that a considerable amount of budget appropriations for 2006 had been carried over to 2007 due to the nature of the projects dealt with by the Agency, |
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—

noted that a considerable amount of budget appropriations for 2006 had been carried over to 2007 due to the nature of the projects dealt with by the Agency,

| — | noted that in December 2006 the Agency’s Management Board decided to undertake a revision of the scale fees system in consultation with the competent national authorities; |
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—

noted that in December 2006 the Agency’s Management Board decided to undertake a revision of the scale fees system in consultation with the competent national authorities;

| 1. | Underlines that the Agency’s budget is financed both from the EU Budget and mainly by fees paid by pharmaceutical industry applicants for obtaining or maintaining a Community marketing authorisation. However notes that the EC general contribution increased by 24,48 % between 2006 and 2007 and represents 24,13 % of the total 2007 revenue; is aware in this context of newly assigned tasks arising from Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use (7) and an increase in the orphan medicines budget line; |
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1.

Underlines that the Agency’s budget is financed both from the EU Budget and mainly by fees paid by pharmaceutical industry applicants for obtaining or maintaining a Community marketing authorisation. However notes that the EC general contribution increased by 24,48 % between 2006 and 2007 and represents 24,13 % of the total 2007 revenue; is aware in this context of newly assigned tasks arising from Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use (7) and an increase in the orphan medicines budget line;

| 2. | 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 and to accelerate the development and implementation of Telematics programmes; |
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2.

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 and to accelerate the development and implementation of Telematics programmes;

| 3. | Considers the Agency as a source of important scientific advice, science-based recommendations, best practice for medicines evaluation and supervision in Europe and welcomes the contributions to the Commission and the Member States towards the harmonisation of regulatory standards at international level; |
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3.

Considers the Agency as a source of important scientific advice, science-based recommendations, best practice for medicines evaluation and supervision in Europe and welcomes the contributions to the Commission and the Member States towards the harmonisation of regulatory standards at international level;

| 4. | Encourages the Agency to continue its action in the Orphan Medicines field; discourages, however, the decrease in the Orphan Medicines contribution, mainly due to a change in the policy for orphan fee reductions resulting from the flexibility provided by Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (8), which none the less results in (generates) a reduction of 26,25 % in 2007 compared to 2006; |
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4.

Encourages the Agency to continue its action in the Orphan Medicines field; discourages, however, the decrease in the Orphan Medicines contribution, mainly due to a change in the policy for orphan fee reductions resulting from the flexibility provided by Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (8), which none the less results in (generates) a reduction of 26,25 % in 2007 compared to 2006;

| 5. | Emphasises the role of the Agency to monitoring the safety of medicines through the pharmacovigilance network; calls, however, for constant improvement of the vigilance level; |
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5.

Emphasises the role of the Agency to monitoring the safety of medicines through the pharmacovigilance network; calls, however, for constant improvement of the vigilance level;

Weaknesses in budgetary management concerning the Telematics programme

| 6. | Notes the ECA’s criticism that, as in 2006, the high level of carry-overs for administrative expenditure was mainly due to the Telematics programme; notes the ECA’s statement that this situation was at odds with the principle of annuality and that the Agency must ensure better planning and monitoring of the implementation of the programme; |
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6.

Notes the ECA’s criticism that, as in 2006, the high level of carry-overs for administrative expenditure was mainly due to the Telematics programme; notes the ECA’s statement that this situation was at odds with the principle of annuality and that the Agency must ensure better planning and monitoring of the implementation of the programme;

| 7. | Notes the ECA’s recommendation that the Agency should consider using the differentiated appropriations system for the Telematics programme, which was more suitable for the budgetary management of such programmes; |
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7.

Notes the ECA’s recommendation that the Agency should consider using the differentiated appropriations system for the Telematics programme, which was more suitable for the budgetary management of such programmes;

| 8. | Calls on the Agency to implement the ECA’s recommendation to use differentiated appropriations for the Telematics programme promptly; requests that the Agency report on the action taken in its annual activity report for 2008; |
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8.

Calls on the Agency to implement the ECA’s recommendation to use differentiated appropriations for the Telematics programme promptly; requests that the Agency report on the action taken in its annual activity report for 2008;

Weaknesses as regards procurement procedures

| 9. | Notes the ECA’s finding with regard to procurement procedures, stating that:






  — | in two cases the procedures chosen were not sufficiently justified, |
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9.

Notes the ECA’s finding with regard to procurement procedures, stating that:

—

in two cases the procedures chosen were not sufficiently justified,

| — | in three cases the evaluation methods for the price criteria were inadequate, |
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—

in three cases the evaluation methods for the price criteria were inadequate,

| — | in one case of a joint procurement procedure with five other agencies the volume of the services to be procured had not been adequately identified; |
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—

in one case of a joint procurement procedure with five other agencies the volume of the services to be procured had not been adequately identified;

| 10. | Notes the Agency’s replies according to which:






  — | it established a formula for the objective evaluation of price as an award criteria with effect from 17 March 2008, |
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10.

Notes the Agency’s replies according to which:

—

it established a formula for the objective evaluation of price as an award criteria with effect from 17 March 2008,

| — | in the case of the joint procurement procedure the original estimate had to be revalued due to the technological advances that occurred between the definition of services to be provided and the launch of the procurement procedure; |
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—

in the case of the joint procurement procedure the original estimate had to be revalued due to the technological advances that occurred between the definition of services to be provided and the launch of the procurement procedure;

| 11. | Requests the Agency to address the weaknesses in the procurement procedures mentioned above and to report on the action taken in its annual activity report for 2008; |
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11.

Requests the Agency to address the weaknesses in the procurement procedures mentioned above and to report on the action taken in its annual activity report for 2008;

Progress towards ensuring compliance with the fee regulation

| 12. | Notes that the ECA, in its 2006 annual report, found that the Agency’s practice was in breach of its fee regulation for the following reasons: the Agency’s customers were billed an amount which was divided into two parts, the Agency’s costs and an amount which was repaid to the Member States’ rapporteurs to cover their own costs; and the Member States’ rapporteurs however never provided full evidence of their actual costs; |
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12.

Notes that the ECA, in its 2006 annual report, found that the Agency’s practice was in breach of its fee regulation for the following reasons: the Agency’s customers were billed an amount which was divided into two parts, the Agency’s costs and an amount which was repaid to the Member States’ rapporteurs to cover their own costs; and the Member States’ rapporteurs however never provided full evidence of their actual costs;

| 13. | Notes that the ECA, in its 2007 annual report, followed up on these findings, stating that the Agency’s Management Board set up a costing group which made a proposal for an alternative option for remunerating the rapporteurs at the end of 2007; |
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13.

Notes that the ECA, in its 2007 annual report, followed up on these findings, stating that the Agency’s Management Board set up a costing group which made a proposal for an alternative option for remunerating the rapporteurs at the end of 2007;

| 14. | Insists, in accordance with the ECA’s recommendation, that the Agency make further progress to resolve this issue and report on the follow-up action taken in its annual activity report for 2008; |
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14.

Insists, in accordance with the ECA’s recommendation, that the Agency make further progress to resolve this issue and report on the follow-up action taken in its annual activity report for 2008;

| 15. | Refers for other observations accompanying its Decision on discharge which are of a horizontal nature to its Resolution of 23 April 2009 on financial management and control of EU agencies (9). |
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15.

Refers for other observations accompanying its Decision on discharge which are of a horizontal nature to its Resolution of 23 April 2009 on financial management and control of EU agencies (9).

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(1)  OJ C 278, 31.10.2008, p. 10.

(2)  OJ C 311, 5.12.2008, p. 27.

(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 88, 31.3.2009, p. 175.

(7)  OJ L 378, 27.12.2006, p. 1.

(8)  OJ L 35, 15.2.1995, p. 1.

(9)  See page 206 of this Official Journal.

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