REPORT on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2011

22.3.2013 - (C7‑0252/2012 – 2012/2190(DEC))

Committee on Budgetary Control
Rapporteur: Gerben-Jan Gerbrandy

Procedure : 2012/2190(DEC)

Document stages in plenary

Document selected :

A7-0098/2013

Texts tabled :

A7-0098/2013

Debates :

PV 16/04/2013 - 13
CRE 16/04/2013 - 13

Votes :

PV 17/04/2013 - 12.25
Explanations of votes

Texts adopted :

P7_TA(2013)0150

1. PROPOSAL FOR A EUROPEAN PARLIAMENT DECISION

1. PROPOSAL FOR A EUROPEAN PARLIAMENT DECISION

on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2011

(C7‑0252/2012 – 2012/2190(DEC))

The European Parliament,

– having regard to the final annual accounts of the European Medicines Agency for the financial year 2011,

– having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2011, together with the Agency’s replies[1],

– having regard to the Council’s recommendation of 12 February 2013 (05753/2013 – C7‑0041/2013),

– 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, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, Euratom) No 1605/2002[3], and in particular Article 208 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 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 (A7-0098/2013),

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 2011;

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).

2. PROPOSAL FOR A EUROPEAN PARLIAMENT DECISION

on the closure of the accounts of the European Medicines Agency for the financial year 2011

(C7‑0252/2012 – 2012/2190(DEC))

The European Parliament,

– having regard to the final annual accounts of the European Medicines Agency for the financial year 2011,

– having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2011, together with the Agency’s replies[6],

– having regard to the Council’s recommendation of 12 February 2013 (05753/2013 – C7‑0041/2013),

– 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[7], and in particular Article 185 thereof,

– having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council[9] establishing a European Medicines Agency, and in particular Article 68 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 (A7-0098/2013),

1. Approves the closure of the accounts of the European Medicines Agency for the financial year 2011;

2. Instructs its President to forward this Decision to the Executive Director of the European Medicines Agency, the Council, the Commission and the Court of Auditors, and to arrange for its publication in the Official Journal of the European Union (L series).

3. MOTION FOR A EUROPEAN PARLIAMENT RESOLUTION

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 2011

(C7‑0252/2012 – 2012/2190(DEC))

The European Parliament,

– having regard to the final annual accounts of the European Medicines Agency for the financial year 2011,

– having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2011, together with the Agency’s replies[11],

– having regard to the Council’s recommendation of 12 February 2013 (05753/2013 – C7‑0041/2013),

– 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[12], and in particular Article 185 thereof,

– having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council[14] establishing a European Medicines Agency, and in particular Article 68 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 (A7-0098/2013),

A. whereas the Court of Auditors stated that it has obtained reasonable assurances that the annual accounts of the European Medicines Agency ("the Agency") for the financial year 2011 are reliable and that the underlying transactions are legal and regular,

B. whereas on 23 October 2012, Parliament granted the Executive Director of the Agency discharge for the implementation of its budget for the financial year 2010[16], and in its resolution accompanying the discharge, inter alia:

– called on the Agency to inform the discharge authority about the timeframe and outcomes for the remaining 46 % of the screening process concerning declarations of interest of its experts and committee members who have been actively involved in the Agency's activities between 1 January and 31 May 2012 against their curriculum vitae by the start of the next discharge procedure,

– asked the Agency to provide the discharge authority with a precise timetable for the implementation of a new ex ante and ex post system for declarations of interest, notably by means of random comparison with curriculum vitae and information furnished by experts at national level,

– called on the Agency to introduce a special section describing the actions taken to prevent and manage conflict of interest in each of its future annual activity reports (AARs), which should include, inter alia:

- the number of alleged conflict of interest cases verified,

- the number of revolving door cases,

- the measures taken in each category of cases,

- the number of breach of trust procedures launched and their outcomes,

- the sanctions applied,

– requested the Agency to inform the discharge authority of the detailed measures taken,

C. whereas the Agency's budget for 2011 was EUR 208 863 000, which represents a nominal increase of 0,22 % over the financial year 2010,

D. whereas the overall contribution of the Union to the Agency's budget for 2011 was EUR 39 765 191,39, compared to EUR 36 755 652,07 in 2010;

Follow-up of 2010 discharge

1. Acknowledges from the Agency that as regards an ex post check of the declarations of interest of its experts and committee members, a representative sample of the remaining 46 % of the experts will be included in the ex post check currently being performed; notes that a new, more thorough check is being developed as a result of lessons learned from the ex post control check performed in the context of the 2010 discharge; takes note of the timetable as communicated by the Agency and awaits to be duly informed on the outcome of the check;

2. Notes with satisfaction that a special section describing the actions taken to prevent and manage conflicts of interest is to be introduced in each of the Agency's AARs, starting with the 2012 AAR;

Budget and financial management

3. Recalls that the total Union contributions amounted to EUR 39 765 191,39 for 2011, which represents an 8,65 % increase compared to the previous year;

4. Acknowledges that the Agency's budget is financed by both the Union budget and fees paid by the pharmaceutical industry when applying for, obtaining or maintaining Union marketing authorisations; finds from the annual accounts that in 2011, 77,7 % of the Agency's revenue is estimated to have derived from the fee revenue, which continues to increase year on year, the relative percentage income from the Union contribution 18,3% in 2011 (18,8 % in 2010, or 14 % if the recovery of surplus was deduced from the total Union contribution);

5. Observes that in terms of committed and paid appropriations, the Agency's execution rate stands at 95,21 % and 81,97 % respectively, compared with 95,65 % and 79,10 % in 2010; calls on the Agency to continue its efforts to improve its execution rate of payment;

6. Notes with concern that as in its previous reports, the Court of Auditors has noted the need to introduce a system of remuneration for services provided by Member States authorities, based on their real costs; regrets that no progress has been made on this issue since 2009, when a proposal for a new payment system was presented to the Management Board but no agreement was reached; notes that the Agency will present a new proposal for a new payment system to the Management Board in March 2013; acknowledges the efforts made by the Agency's executives to encourage a decision by the Management Board to revise the system of remuneration of Member States services based on real costs; is fully aware of the fact that the little progress made is due to the lack of decision taken by the Management Board; welcomes, therefore, the approach by the Agency's administration to call upon the Commission for further assistance in this matter; urges the Agency to inform the discharge authority about the developments on this issue, inter alia on the state of play as regards the new action plan and the Management Board's position on it;

Carryovers appropriations

7. Is concerned that once again, the Court of Auditors reported that payment appropriations for Title II ("Administrative expenditure") amounting to EUR 9 600 000 have been carried over to 2012, representing 29 % of the Title II budget, as well as payment appropriations amounting to EUR 10 300 000 for Title III ("Operational expenditure"), representing 34 % of the Title III budget; believes the level of carry-over to be excessive and at odds with the principle of annuality;

8. Notes with concern the difference between the Court of Auditors' conclusion and the Agency's reply as regards the framework contract for Information Technology (IT) services concluded in 2009, for which the Court had qualified its opinion on the legality and regularity of the transactions underlying the Agency’s 2009 accounts; notes that the Court of Auditors considers the increase of the original contract ceiling to be irregular, while the Agency considers that the IT framework contract was not irregular, and therefore does not consider its extension as irregular either; urges the Agency to provide further information on the matter and to take steps in order to resolve the contradiction;

Procurement procedures

9. Acknowledges from the Court of Auditors that there is scope for improving the transparency of procurement procedures as regards the justification of the estimated contract volumes and the definition, publication and application of selection criteria; notes with satisfaction that the Agency has taken note of the Court of Auditors' comments and updated its procedures with a view to transparency and documentation;

Recruitment procedures

10. Notes that in 2011, the Agency advertised 15 vacancies for temporary agent positions and that at year-end, the total number of staff at the Agency increased from 656 to 689;

11. Acknowledges from the Court of Auditors the need to improve the transparency of staff selection procedures; notes with concern that Selection Board members did not always complete their conflict of interest declarations or did not do so in a timely manner and there was no evidence of any action taken to address the issues raised by those declarations; regrets that the documentation of the Selection Board's proceedings was not always adequate and that there is no evidence as to how the method for the short-listing of candidates was established and that the questions for the written tests or interviews were set before the examinations;

12. Notes from the Agency that it has taken note of the Court of Auditors' comments and updated its procedures with a view to transparency and timely documentation; considers that some of the provisions of the Staff Regulations may present a considerable administrative burden; therefore encourages the Commission to allow for a certain degree of simplification under Article 110 of the Staff Regulations in regard to the agencies;

Conflict of interest

13. Welcomes the fact that the Court of Auditors carried out an audit to evaluate the policies and procedures for the management of conflict of interest situations for four European agencies, including the European Medicines Agency, and presented its results in its Special Report 15/2012;

14. Notes that according to the findings of the Court of Auditors, at the time of completion of the field work (October 2011), the Agency did not adequately manage conflict of interest situations but has developed one of the most advanced policies and procedure for declaring, assessing and managing conflicts of interest;

15. Welcomes the fact that the Agency has taken a number of steps following the discharge authority's recommendations for 2010, the Court of Auditors' audit and the publication of Special Report 15/2012, in particular:

- the policy on the handling of conflicts of interests of members and experts of scientific committees, an already revised system which came into effect on 29 September 2011, was further revised in 2012 (mainly to give clearer guidance) and became effective on 3 April 2012,

- compulsory screening of the declared conflicts of interests of scientific committees’ members was introduced on 29 September 2011; the possibility, moreover, of pre-screening any expert prior to the formal Agency's evaluation for involvement in its activities is offered to all nominating authorities,

- a revised policy on the handling of conflicts of interests of the Management Board (in line with the policy for scientific committees’ members/experts) came into effect on 3 April 2012,

- breach of trust procedures were developed for both scientific committees’ members/experts (which came into effect on 3 April 2012) and Management Board members (which came into effect on 7 June 2012),

- as regards transparency, the recording of declared interests has been further finetuned insofar as all restricted involvements put in place vis-à-vis the agenda points of the meeting are now recorded (undertaken before December 2012);

16. Urges the Agency to continue implementing the Court of Auditors' recommendations in order to avoid any conflict of interest in its various structures of governance and operation, and to report to the discharge authority on a six months basis on the implementation of the abovementioned policies and procedures, as well as on any further developments regarding management of conflict of interest;

17. Calls on the agency to start a structured dialogue with civil society on matters relating to conflicts of interest, to invite the organisations concerned at least twice a year to discuss matters of common interest based on an agreed agenda and to inform the discharge authority on the outcome of those deliberations;

18. Welcomes the Agency's commitment to undertake in the first half of 2013 a review of the implementation of its revised policy on the handling of conflicts of interests and that an ex ante and ex post check on the handling of conflicts of interests is currently being developed for implementation in the second quarter of 2013; calls on the Agency to keep the discharge authority informed on their respective outcomes;

19. Welcomes the fact that after the former Head of the Legal Service left the Agency in June 2012 to join a US-based law firm having a number of pharmaceutical industry companies as clients as senior counsel, the Executive Director of the Agency launched a review of his work as Head of the Legal Service, Chair of the Joint Committee, Chair of the Disciplinary Committee and as a member of the Advisory Committee on Procurement and Contracts; acknowledges that no evidence of conflicts of interest nor breach of obligations provided in Articles 11 and 11a of the Staff Regulations could be identified; welcomes the fact that in accordance with Article 16 of the Staff Regulations, the Executive Director imposed some restrictions to the activities of the former Head of Legal Service for a period of two years following his leaving the Agency; calls on the Agency to provide the discharge authority with detailed information on those restrictions;

Internal audit

20. Takes note that an in-depth risk assessment was conducted to determine the audit priorities and as a result, the audit topic agreed for 2012 was ‘Planning and Budgeting’, and the Internal Audit Service (IAS) carried out an audit entitled "Operational Business Continuity in the European Medicines Agency";

21. Notes that, based on the results of that audit, the IAS raised 13 recommendations, seven of which were rated as "very important", five as "important" and one as "desirable"; notes with satisfaction that all the recommendations were accepted by the Management Board and that the action plan prepared by the Agency to rectify those recommendations was considered to be adequate by the IAS;

22. Notes that the IAS also carried out an IT risk assessment exercise in a form of a risk self-assessment, providing an overview of IT risk exposures;

23. Acknowledges that as regards earlier recommendations issued by the IAS and their implementation by the Agency by 31 December 2011, there are nine ‘very important’ recommendations open from previous audits, eight of which have been implemented by the Agency and are under review by IAS, and that no critical recommendations remained open on 31 December 2011;

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24. Refers, in respect of the other observations accompanying its Decision on discharge, which are of a horizontal nature, to its resolution of... 2013[17] on the performance, financial management and control of the agencies.

28.1.2013

OPINION of the Committee on the Environment, Public Health and Food Safety

for the Committee on Budgetary Control

on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2011

(C7-0252/2012 - 2012/2190(DEC))

Rapporteur: Jutta Haug

SUGGESTIONS

The Committee on the Environment, Public Health and Food Safety calls on the Committee on Budgetary Control, as the committee responsible, to incorporate the following suggestions in its motion for a resolution:

1. Welcomes the fact that the Court of Auditors considers the transactions underlying the annual accounts of the European Medicines Agency (the "Agency") for the financial year 2011 as legal and regular in all material respects; underlines again that the discharge procedure shall focus on the preceding year; is aware that any progress made since then should be duly noted and taken into account;

2. Points to the role of the European Medicines Agency in protecting and promoting public and animal health by assessing and supervising medicines for human or veterinary use;

3. Draws attention to the Roadmap agreed by the European Commission on 19 December 2012 as follow-up as requested by the European Parliament in the "Joint Statement and Common Approach of the European Parliament, the Council of the EU and the European Commission on decentralised agencies" in order to improve the governance, efficiency and transparency of agencies which includes self-evident initiatives to tackle conflict of interests;

4. Thinks it is noteworthy in this context that the special report on Conflict of Interests by the Court of Auditors is not taking into account to the full the latest developments and improvements put in place by the Agency; therefore, notes with satisfaction the improvement of all procedures related to transparency and possible conflicts of interest in the Agency, recalls the importance of continuously working for strengthening and enhancement of all policies related to transparency and independence and will support the Executive Director in his further efforts;

5. Looks to the Agency to produce a report on the implementation of the system of ex ante and ex post verification of declarations of interests; shares the view of the Agency’s Executive Director that, given its scope, a system of that kind is beyond the Agency’s capacity and remit; believes, therefore, that one option to consider should be a legislative initiative whereby holders of a marketing authorisation (MA) for a pharmaceutical product would be obliged to publish agreements and all benefits in cash or in kind that they provided, directly or indirectly, to experts or bodies with whom they worked;

6. Notes that in 2011, the Agency had resources available of EUR 208 863 000 of which EUR 27 900 000 had been EU budget contributions; is satisfied that 552 of 567 available posts had been occupied and notes that 177 contract agents and seconded national experts were employed by the end of 2011;

7. Welcomes the efforts by the Agency to strengthen its procedures to comply with the budgetary principle of annuality by creating a team for analysis and better planning to avoid high carry-overs in the future;

8. Takes note of the comment made by the Court of Auditors in a relation to a framework contract for IT services; reminds in this context that the major calculating error was made in 2009, referred to in the 2009 discharge decision and notes that since then the procedure and calculation were corrected in the necessary ways;

9. Will monitor closely the improved staff selection procedure for more transparency as well as full and timely documentation;

10. Acknowledges the efforts by the executive level of the Agency to encourage a decision by the Management Board to revise the system of remuneration of Member States services based on real costs; is fully aware of the fact that the little progress is due to the lack of any decision in the Management Board; welcomes therefore the approach by the Agency's administration to call upon the European Commission for further assistance in this matter;

11. Recommends, on the basis of the facts available, that discharge be granted to the Executive Director of the European Medicines Agency in respect of the implementation of the Agency’s budget for the financial year 2011.

RESULT OF FINAL VOTE IN COMMITTEE

Date adopted	23.1.2013
Result of final vote	+: –: 0:	52 8 0
Members present for the final vote	Kriton Arsenis, Sophie Auconie, Paolo Bartolozzi, Sandrine Bélier, Lajos Bokros, Milan Cabrnoch, Martin Callanan, Nessa Childers, Yves Cochet, Esther de Lange, Anne Delvaux, Bas Eickhout, Jill Evans, Karl-Heinz Florenz, Elisabetta Gardini, Gerben-Jan Gerbrandy, Matthias Groote, Françoise Grossetête, Cristina Gutiérrez-Cortines, Jolanta Emilia Hibner, Karin Kadenbach, Christa Klaß, Eija-Riitta Korhola, Holger Krahmer, Jo Leinen, Corinne Lepage, Kartika Tamara Liotard, Linda McAvan, Miroslav Ouzký, Gilles Pargneaux, Antonyia Parvanova, Pavel Poc, Frédérique Ries, Oreste Rossi, Dagmar Roth-Behrendt, Kārlis Šadurskis, Carl Schlyter, Richard Seeber, Theodoros Skylakakis, Claudiu Ciprian Tănăsescu, Salvatore Tatarella, Thomas Ulmer, Åsa Westlund, Glenis Willmott, Sabine Wils, Marina Yannakoudakis
Substitute(s) present for the final vote	Margrete Auken, José Manuel Fernandes, Gaston Franco, Judith A. Merkies, Miroslav Mikolášik, Vittorio Prodi, Birgit Schnieber-Jastram, Renate Sommer, Rebecca Taylor, Vladimir Urutchev, Peter van Dalen, Anna Záborská, Andrea Zanoni
Substitute(s) under Rule 187(2) present for the final vote	Olle Ludvigsson

RESULT OF FINAL VOTE IN COMMITTEE

Date adopted	19.3.2013
Result of final vote	+: –: 0:	24 3 0
Members present for the final vote	Inés Ayala Sender, Zuzana Brzobohatá, Andrea Češková, Ryszard Czarnecki, Tamás Deutsch, Martin Ehrenhauser, Jens Geier, Gerben-Jan Gerbrandy, Ingeborg Gräßle, Cătălin Sorin Ivan, Bogusław Liberadzki, Jan Mulder, Eva Ortiz Vilella, Monika Panayotova, Aldo Patriciello, Crescenzio Rivellini, Paul Rübig, Petri Sarvamaa, Bogusław Sonik, Bart Staes, Georgios Stavrakakis, Michael Theurer
Substitute(s) present for the final vote	Chris Davies, Derk Jan Eppink, Edit Herczog, Monika Hohlmeier, Ivailo Kalfin, Agnès Le Brun, Véronique Mathieu Houillon, Derek Vaughan

[1] OJ C 388, 15.12.2012, p. 116.
[2] OJ L 248, 16.9.2002, p. 1.
[3] OJ L 298, 26.10.2012, p. 1.
[4] OJ L 136, 30.4.2004, p. 1.
[5] OJ L 357, 31.12.2002, p. 72.
[6] OJ C 388, 15.12.2012, p. 116.
[7] OJ L 248, 16.9.2002, p. 1.
[8] OJ L 298, 26.10.2012, p. 1.
[9] OJ L 136, 30.4.2004, p. 1.
[10] OJ L 357, 31.12.2002, p. 72.
[11] OJ C 388, 15.12.2012, p. 116.
[12] OJ L 248, 16.9.2002, p. 1.
[13] OJ L 298, 26.10.2012, p. 1.
[14] OJ L 136, 30.4.2004, p. 1.
[15] OJ L 357, 31.12.2002, p. 72.
[16] OJ L 350, 20.12.2012, p. 82.
[17] Texts adopted, P7_TA-PROV(2013)...

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