SECOND REPORT on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2010

1.10.2012 - (C7‑0281/2011 – 2011/2220(DEC))

Committee on Budgetary Control
Rapporteur: Monica Luisa Macovei

Procedure : 2011/2220(DEC)

Document stages in plenary

Document selected :

A7-0298/2012

Texts tabled :

A7-0298/2012

Debates :

Votes :

PV 23/10/2012 - 13.3
Explanations of votes
Explanations of votes

Texts adopted :

P7_TA(2012)0366

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 2010

(C7‑0281/2011 – 2011/2220(DEC))

The European Parliament,

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

– having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2010, together with the Agency’s replies[1],

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

– having regard to its Decision of 10 May 2012[2] postponing the discharge decision for the financial year 2010, its accompanying Resolution and the replies by the Executive Director of the European Medicines Agency,

– 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[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 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 on the Financial Regulation applicable to the general budget of the European Communities[5], and in particular Article 94 thereof,

– having regard to the Joint Statement and Common Approach adopted in June 2012 by the European Parliament, the Council and the Commission, resulting from the work of the Interinstitutional Working Group on decentralised agencies, and in particular the sections on governance, operations, programming, accountability and transparency,

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

– having regard to the second report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A7-0298/2012),

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 2010;

2. Sets out its observations in the resolution below;

3. Instructs its President to forward this Decision and the resolution that forms an integral part of it to the Executive Director of the European 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 2010

(C7‑0281/2011 – 2011/2220(DEC))

The European Parliament,

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

– having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2010, together with the Agency’s replies[6],

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

– having regard to its Decision of 10 May 2012[7] postponing the discharge decision for the financial year 2010, its accompanying Resolution and the replies by the Executive Director of the European Medicines Agency,

– 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[8], 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 establishing a European Medicines Agency[9], and in particular Article 68 thereof,

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

– having regard to the second report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A7-0298/2012)

1. Approves the closure of the accounts of the European Medicines Agency for the financial year 2010;

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 2010

(C7‑0281/2011 – 2011/2220(DEC))

The European Parliament,

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

– having regard to the Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2010, together with the Agency’s replies[11],

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

– having regard to its Decision of 10 May 2012[12] postponing the discharge decision for the financial year 2010, its accompanying Resolution and the replies by the Executive Director of the European Medicines Agency,

– 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[13], 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 establishing a European Medicines Agency[14], and in particular Article 68 thereof,

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

– having regard to the second report of the Committee on Budgetary Control and the opinion of the Committee on the Environment, Public Health and Food Safety (A7-0298/2012),

A. whereas on 10 May 2012, the European Parliament postponed its decision on the discharge and closure of the accounts of the European Medicines Agency (the Agency) for the financial year 2010,

B whereas the Agency addressed to a large extent the weaknesses highlighted in the report of 10 May 2012 and provided the discharge authority with substantial information by letters of 2 and 6 July 2012 and of 2, 7 and 24 August 2012,

C. whereas the discharge is a valid instrument of the European Parliament, which requires a decision based on factual and substantive arguments; recalling, in this context, the existing rules, i.e. the Staff Regulations for Officials and Conditions of Employment of Other Servants of the European Community, the Financial Regulation applicable to the European Communities, the Agency's founding regulation and specific policies and procedures set up by the Agency,

1. Recalls the importance of the work of the Agency by providing the best possible scientific advise on any question relating to the evaluation of the quality, the safety and the efficacy of medicinal products for human and veterinary use to the Member States and the institutions;

Follow-up of 2009 discharge

2. Notes that on 7 June 2012 the Management Board endorsed the new structure and scope of the Advisory Committee on Procurement and Contract; welcomes that the Agency put in place a multiannual procurement plan for 2012-2014 as requested by the discharge authority in its report on the discharge for the financial year 2009;

Carryover appropriations and cancellations

3. Reminds that the Court of Auditors reported a high level of carryovers for the financial year 2010 as well as a lack of compliance with the budgetary principle of annuality; welcomes the fact that the Agency has strengthened its procedures of fee revenue forecasting by creating a team which analyses, in close cooperation with the pharmaceutical industry, the status of pharmaceutical product research before submission to the Agency; notes the Agency's firm commitment to work with Directorate General Budget of the Commission in order to achieve a stable framework with the current revision of the Framework Financial Regulations;

4. Gives full support to all efforts at the executive and administrative levels of the Agency to reform the payment system for services provided by Member States' authorities which should clearly be based on the real costs; welcomes therefore the Agency's initiative to prepare a new proposal to be submitted to the Management Board; urges and expects the Management Board to discuss and decide on this payment system without delay;

Transparency and Management of conflict of interest

5. Takes note that the Agency is organising for November 2012 a workshop gathering a broad range of interested parties in the view of developing the modalities of providing public access to clinical trial data, and that the selection and training of the Agency's scientific staff aimed at strengthening the analysis of raw data is well advanced;

6. Takes note that the Agency has improved the scope and methodology of the systematic ex-ante and ex-post controls related to the screening of declaration of interest, also welcomes the Agency's decision to perform a yearly evaluation of its revised policy on declaration of interest; invites therefore the Agency to keep the discharge authority informed on the implementation of its revised policy and in particular of its systematic ex-ante and ex-post controls on a 6-month basis;

7. Notes with satisfaction that the Agency has started publishing the minutes of some Scientific Committees' meetings, starting with the Paediatric Committee (PDCO) in July 2012; takes note that the publication process of the minutes for all Scientific Committee meetings will be completed only by the end of 2013;

8. Notes that the concerns raised with regard to the financial circuits and the potential conflicts of interests in processing payments due to insufficient segregation of duties were addressed by the Agency with the introduction of SAP accounting software as its central financial system;

9. Underlines that in June 2012 a 'revolving door' case occurred in the Agency, the former Head of Legal Service joined as senior counsel a US-based law firm having a number of pharmaceutical industry companies as clients; takes note that the Executive Director of the Agency launched a review of the work performed by the former Head of Legal Service; invites the Agency to inform the discharge authority on the outcomes of this review by the end of 2012;

10. Takes note that the Agency proceeded to a screening process of the 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; notes that around 54 % of the experts and committee members provided the Agency with updated curriculum vitae; calls on the Agency to inform the discharge authority on the timeframe and outcomes of the screening process for the remaining 46 % by the start of the next discharge procedure;

11. Welcomes the Agency's initiative to publish on its website the declarations of interests of its staff occupying management positions and of the experts involved in the evaluation of medicinal products; notes with interest that the list of experts also indicates their risk level in terms of conflict of interest; welcomes the Agency's commitment to publish next to the declarations of interest the professional and educational profiles of the scientific experts belonging to its Expert Database from first quarter 2013 and will follow closely the publication process during the future discharge procedures;

12. Welcomes the announcement by the Agency that it plans to introduce an ex ante and ex post system for declarations of interest, notably by means of random comparison with CVs and information furnished by experts at national level; asks the Agency to provide the budgetary control authority with a precise timetable for the implementation of this new system;

13. Agrees with the Agency that a high level of reliability and honesty concerning the declaration of interests can only be achieved if pharmaceutical companies themselves make public the list of experts and research centres with which they work, and the sums concerned in their financial links with them; agrees with the Agency that thought should be given to whether a legislative initiative in this field would be pertinent;

14. Acknowledges the Agency's efforts to address the discharge authority's concerns with regards to the prevention and management of conflict of interest; notes in particular the reports of 29 June 2012 and 7 August 2012 received by the discharge authority on the review of the conflict of interest management cases identified by the IAS and on the review of potential conflicts of interest of experts involved in assessing the medicinal product Pandemrix;

15. Is firmly convinced that necessary steps have to be taken should cases of non-compliance with existing rules occur; believes that, in such cases, the Agency has to draw up an action plan aiming to remedy the shortcomings, with a precise timetable, that its implementation should be monitored by the European Parliament, and that either the European Parliament or the European legislator has to address these problems by changing the existing rules and regulations to eliminate possible loopholes;

16. Calls on the Agency to introduce in each of its annual activity report a special section describing the actions taken to prevent and manage conflict of interest, which shall 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;

requests the Agency to inform the discharge authority of the detailed measures taken;

17. Considers it noteworthy that the committee responsible is in close contact with the EMA by inviting the Executive Director for an exchange of views at least once a year, by having appointed a contact person from amongst its members and by visiting the Agency every two years; recalls that the last visit took place in June 2011;

18. Welcomes, in general, the agreement on the Joint Statement and the Common Approach of the European Parliament, the Council and the Commission on decentralised agencies; recalls that certain elements of importance to the discharge have been addressed and taken up; believes that the roadmap on the follow-up to the Common Approach will take due account of those issues;

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

20.9.2012

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 2010

(C7-0281/2011 - 2011/2220(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. Recalls the importance of the work of the European Medicines Agency (EMA) by providing the best possible scientific advise on any question relating to the evaluation of the quality, the safety and the efficacy of medicinal products for human and veterinary use to the EU Member States and the EU institutions;

2. Considers the discharge a valid instrument of the European Parliament, which requires a decision based on factual and substantive arguments; recalls, in this context, the existing rules, i.e. the Staff Regulations for Officials and Conditions of Employment of Other Servants of the European Community, the Financial Regulation applicable to the European Communities, the respective Agency's founding regulation and specific policies and procedures set up in the EMA;

3. Is firmly convinced that necessary steps have to be taken should cases of non-compliance with existing rules occur; believes that, in such cases, the EMA has to draw up an action plan aiming to remedy the shortcomings, with a precise timetable, that its implementation should be monitored by the European Parliament, and that either the European Parliament or the European legislator has to address these problems by changing the existing rules and regulations to eliminate possible loopholes;

4. Has taken careful note of the detailed correspondence between the administration level of the EMA and the CONT rapporteur before and after the plenary decision of postponing the granting of the discharge;

5. Has already addressed the problematic of high carry-overs, the subsequent professional activities of the former Executive Director, the missing Declarations of Interests by a number of experts involved in the evaluation of medicinal products also mentioned in the Internal Audit Service follow-up report and the overdue decision by the Management Board to reform the payment system for services provided by Member States' authorities in its first opinion to the responsible committee; is of the opinion that the EMA has already made significant efforts to strengthen its internal procedures to assure the independence of its experts and its staff and has asked to be informed twice a year about the improved implementation of the measures taken in this regard;

6. Welcomes the announcement by the EMA that it plans to introduce an ex-ante and ex-post system for Declarations of Interest, notably by means of random comparison with CVs and information furnished by experts at national level; asks the EMA to provide the budgetary control authority with a precise timetable for the implementation of this new system;

7. Agrees with the EMA that a high level of reliability and honesty concerning the declaration of interests can only be achieved if pharmaceutical companies themselves make public the list of experts and research centres with which they work, and the sums concerned in their financial links with them; agrees with the EMA that thought should be given to whether a legislative initiative in this field would be pertinent;

8. Points out again that the Court of Auditors made observations on carryovers, IT contracts and the payment system for services provided by national authorities but considered the EMA's accounts of 2010 reliable, legal and regular;

9. Considers it noteworthy that the committee responsible is in close contact with the EMA by inviting the Executive Director for an exchange of views at least once a year, by having appointed a contact person from amongst its members and by visiting the EMA every two years; recalls that the last visit took place in June 2011;

10. Welcomes, in general, the agreement on the Joint Statement and the Common Approach of the European Parliament, the Council and the Commission on decentralised agencies; recalls that certain elements of importance to the discharge have been addressed and taken up; believes that the roadmap on the follow-up to the Common Approach will take due account of those issues;

11. Believes that the discharge decision for the EMA cannot be based upon additional requirements, e.g. OECD guidelines, when the implementation of those requirements have neither been officially asked for by the EU legislator nor by specific arrangements within the Agencies during the respective discharge procedure; invites the European institutions to examine whether it is advisable to incorporate and to commit to additional guidelines in a possible common framework for all European institutions and bodies;

12. Is of the opinion, on the basis of the data available, that discharge can be granted to the Executive Director of the European Medicines Agency in respect of the implementation of the EMA's budget for the financial year 2010.

RESULT OF FINAL VOTE IN COMMITTEE

Date adopted	19.9.2012
Result of final vote	+: –: 0:	48 7 1
Members present for the final vote	Martina Anderson, Sophie Auconie, Pilar Ayuso, Paolo Bartolozzi, Sergio Berlato, Lajos Bokros, Milan Cabrnoch, Nessa Childers, Esther de Lange, Bas Eickhout, Edite Estrela, Elisabetta Gardini, Gerben-Jan Gerbrandy, Matthias Groote, Cristina Gutiérrez-Cortines, Satu Hassi, Jolanta Emilia Hibner, Dan Jørgensen, Karin Kadenbach, Christa Klaß, Eija-Riitta Korhola, Holger Krahmer, Corinne Lepage, Peter Liese, Zofija Mazej Kukovič, Linda McAvan, Radvilė Morkūnaitė-Mikulėnienė, Vladko Todorov Panayotov, Antonyia Parvanova, Andres Perello Rodriguez, Mario Pirillo, Frédérique Ries, Anna Rosbach, Oreste Rossi, Dagmar Roth-Behrendt, Kārlis Šadurskis, Carl Schlyter, Horst Schnellhardt, Richard Seeber, Theodoros Skylakakis, Claudiu Ciprian Tănăsescu, Salvatore Tatarella, Thomas Ulmer, Anja Weisgerber, Åsa Westlund, Marina Yannakoudakis
Substitute(s) present for the final vote	Nikos Chrysogelos, José Manuel Fernandes, Christofer Fjellner, Jacqueline Foster, Jutta Haug, Judith A. Merkies, Vittorio Prodi, Michèle Rivasi, Marita Ulvskog, Andrea Zanoni

RESULT OF FINAL VOTE IN COMMITTEE

Date adopted	26.9.2012
Result of final vote	+: –: 0:	27 1 0
Members present for the final vote	Marta Andreasen, Jean-Pierre Audy, Inés Ayala Sender, Zigmantas Balčytis, Zuzana Brzobohatá, Andrea Češková, Martin Ehrenhauser, Jens Geier, Gerben-Jan Gerbrandy, Ingeborg Gräßle, Cătălin Sorin Ivan, Iliana Ivanova, Monica Luisa Macovei, Eva Ortiz Vilella, Aldo Patriciello, Crescenzio Rivellini, Theodoros Skylakakis, Bogusław Sonik, Bart Staes
Substitute(s) present for the final vote	Amelia Andersdotter, Jorgo Chatzimarkakis, Cornelis de Jong, Edit Herczog, Markus Pieper, Olle Schmidt
Substitute(s) under Rule 187(2) present for the final vote	Elena Băsescu, Karl-Heinz Florenz, Jutta Haug, Iosif Matula, Cristian Dan Preda, Janusz Władysław Zemke

[1] OJ C 366, 15.12.2011, p. 27.
[2] Texts adopted, P7_TA(2012)0175.
[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 C 366, 15.12.2011, p. 27.
[7] Texts adopted, P7_TA(2012)0175.
[8] OJ L 248, 16.9.2002, p. 1.
[9] OJ L 136, 30.4.2004, p. 1.
[10] OJ L 357, 31.12.2002, p. 72.
[11] OJ C 366, 15.12.2011, p. 27.
[12] Texts adopted, P7_TA(2012)0175.
[13] OJ L 248, 16.9.2002, p. 1.
[14] OJ L 136, 30.4.2004, p. 1.
[15] OJ L 357, 31.12.2002, p. 72.

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