Procedure completed, awaiting publication in Official Journal
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | CONT | STAES Bart (Verts/ALE) | SARVAMAA Petri (EPP), LIBERADZKI Bogusław (S&D), MACOVEI Monica (ECR), ALI Nedzhmi (ALDE), DE JONG Dennis (GUE/NGL), VALLI Marco (EFD), KAPPEL Barbara (ENF) |
| Opinion | ENVI | VĂLEAN Adina-Ioana (EPP) |
Activites
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2018/04/18
Results of vote in Parliament
- Results of vote in Parliament
- Debate in Parliament
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T8-0150/2018
summary
The European Parliament decided to grant discharge to the Director of the European Medicines Agency (EMA) in regard to the implementation of the agency’s budget for the 2016 financial year and to approve the closure of the accounts for the financial year in question. Noting that the Court of Auditors has stated that it has obtained reasonable assurances that the agency’s annual accounts for the financial year 2016 are reliable and that the underlying transactions are legal and regular, Parliament adopted by 534 votes to 45 with 18 abstentions, a resolution containing a series of recommendations, which form an integral part of the decision on discharge and which add to the general recommendations set out in the resolution on performance, financial management and control of EU agencies: Follow-up to the 2014 discharge: Members noted with concern that some of the Court’s comments from the 2014 discharge are still not marked as “completed”, in particular the evaluation of the weaknesses in management control, the dissemination of appropriate pharmacovigilance information to the Member States and to the general public. They called on the agency to complete the corrective actions as soon as possible in 2018 and to report to the discharge authority on their implementation. Agency’s financial statements: the European Medicines Agency’s final budget for the financial year 2016 was EUR 308 422 000, representing an increase of 0.1 % compared to 2015. As a reminder, the agency is a fee-funded agency, with 89.34% of its 2016 revenue stemming from fees paid by the pharmaceutical industry, for services provided, 5.49% stemming from the Union budget to fund various public health and harmonisation activities, and 5.01% stemming from external assigned revenue. Reliability of the accounts: according to the Court’s report, since the introduction of a new IT accounting system in 2011, reporting on commitment workflow and consumption has not been sufficiently transparent. Members noted with regret that, although the matter was repeatedly raised with the Agency, no corrective action has been taken. They called on the Agency to implement corrective actions as soon as possible in 2018. Legality and regularity of transactions: irregularities concerned corporate rate agreements for the provision of accommodation for experts with 25 hotels in London without using a competitive procurement procedure. For six hotels, payments made in 2016 were above the Financial Regulation’s threshold for which an open or restricted competitive procurement procedure is required. The six corporate rate agreements and the related 2016 payments, amounting to some EUR 2.1 million are therefore irregular. Budget and financial management: budget monitoring efforts during the financial year 2016 resulted in a budget implementation rate of 96.30 %, representing an increase of 2.25 % compared with the previous year. It was highlighted that agency was not allowed to create a 'Brexit' contingency reserve. Human resources policy: Members regretted that the gender balance had not been met, since the ratio is 69 % female to 31 % male. They stressed that the staff cuts imposed in recent years have meant a reduction in staff working on tasks that are actually funded by applicants' fees and not by the Union budget. Members observed with satisfaction that the agency put in place a health and safety group for consultation with staff. It also has a policy in place for protecting the dignity of the person and preventing any form of psychological or sexual harassment. Prevention and management of conflicts of interests, transparency and democracy: Parliament noted that the revised policy on the handling of competing interests of the Management Board members came into effect on 1 May 2016 and was further revised in October 2016. The implementation of the revised policy now includes an ex ante evaluation which is performed to compare the details contained in each new declaration, with those of the previous declaration, and with the CV of each board member provided. The agency's Code of Conduct extends the requirements for impartiality and the submission of annual declarations of interests to all members of staff of the agency. Members emphasised the need to establish an independent body with sufficient budgetary resources to support whistleblowers wishing to disclose information on possible irregularities negatively impacting on the Union’s financial interests, while ensuring their confidentiality is protected. Impact of Brexit: Members stressed that the agency will be facing an additional workload and additional budgetary needs throughout the 2018-2020 relocation and transition period, as a consequence of the decision of the United Kingdom (UK) to withdraw from the Union. They called on the Commission to provide adequate staff and budgetary resources in preparation for its relocation in 2019. Parliament also proposed that the agency be authorised to maintain a budgetary reserve generated from revenue fees to respond to unforeseen costs and unfavourable exchange rate fluctuations that may be incurred in 2018 and beyond. They also stressed the need for the accelerated building approval so as to avoid any delays in the start of the construction of the new agency premises in Amsterdam. The agency has disclosed in its financial statements an estimated EUR 448 million in rent for the remaining rental period between 2017 and 2039 as a contingent liability, as the rental contract does not include any exit clause.
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2018/03/26
Committee report tabled for plenary, single reading
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A8-0103/2018
summary
The Committee on Budgetary Control adopted the report by Bart STAES (Greens/EFA, BE) on discharge in respect of the implementation of the budget of the European Medicines Agency (EMA) for the financial year 2016. The committee called on the European Parliament to grant the Executive Director of the Agency discharge in respect of the implementation of the agency’s budget for the financial year 2016. Noting that the Court of Auditors stated that it had obtained reasonable assurance that the annual accounts of the Agency for the financial year 2016 were reliable and that the underlying transactions were legal and regular, Members called on Parliament to approve the closure of the Agency’s accounts. They made, however, a number of recommendations that needed to be taken into account when the discharge is granted, in addition to the general recommendations that appear in the draft resolution on performance, financial management and control of EU agencies: Agency’s financial statements: the European Medicines Agency’s final budget for the financial year 2016 was EUR 308 422 000, representing an increase of 0.1 % compared to 2015. As a reminder, the Agency is a fee-funded agency, with 89.34% of its 2016 revenue stemming from fees paid by the pharmaceutical industry, for services provided, 5.49% stemming from the Union budget to fund various public health and harmonisation activities, and 5.01% stemming from external assigned revenue. Reliability of the accounts: according to the Court’s report, since the introduction of a new IT accounting system in 2011, reporting on commitment workflow and consumption has not been sufficiently transparent. Members noted with regret that, although the matter was repeatedly raised with the Agency, no corrective action has been taken. They called on the Agency to implement corrective actions as soon as possible in 2018. Legality and regularity of transactions: irregularities concerned corporate rate agreements for the provision of accommodation for experts with 25 hotels in London without using a competitive procurement procedure. For six hotels, payments made in 2016 were above the Financial Regulation’s threshold for which an open or restricted competitive procurement procedure is required. The six corporate rate agreements and the related 2016 payments, amounting to some EUR 2.1 million are therefore irregular. Budget and financial management: budget monitoring efforts during the financial year 2016 resulted in a budget implementation rate of 96.30 %, representing an increase of 2.25 % compared with the previous year. It was highlighted that Agency was not allowed to create a 'Brexit' contingency reserve. Prevention and management of conflicts of interests and transparency and democracy: the report noted that the revised policy on the handling of competing interests of the Management Board members came into effect on 1 May 2016 and was further revised in October 2016. The implementation of the revised policy now includes an ex ante evaluation which is performed to compare the details contained in each new declaration, with those of the previous declaration, and with the CV of each board member provided. Impact of Brexit: Members stressed that the Agency will be facing an additional workload and additional budgetary needs throughout the 2018-2020 relocation and transition period, as a consequence of the decision of the United Kingdom (UK) to withdraw from the Union. The Commission is called on to provide adequate staff and budgetary resources in preparation for its relocation in 2019. They proposed in addition that the Agency be authorised to maintain a budgetary reserve generated from revenue fees to respond to unforeseen costs and unfavourable exchange rate fluctuations that may be incurred in 2018 and beyond. They also stressed the need for the accelerated building approval so as to avoid any delays in the start of the construction of the new Agency’s premises in Amsterdam. The Agency has disclosed in its financial statements an estimated EUR 448 million in rent for the remaining rental period between 2017 and 2039 as a contingent liability, as the rental contract does not include any exit clause.
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A8-0103/2018
summary
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2018/03/20
Vote in committee, 1st reading/single reading
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2017/09/13
Committee referral announced in Parliament, 1st reading/single reading
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2017/06/26
Non-legislative basic document published
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COM(2017)0365
summary
PURPOSE: presentation by the Commission of the consolidated annual accounts of the European Union for the financial year 2016, as part of the 2016 discharge procedure. Analysis of the accounts of the European Medicines Agency (EMA). CONTENT: the organisational governance of the EU consists of institutions, agencies and other EU bodies whose expenditure is included in the general budget of the Union. This Commission document concerns the EU's consolidated accounts for the year 2016 and details how spending by the EU institutions and bodies was carried out. The consolidated annual accounts of the EU provide financial information on the activities of the institutions, agencies and other bodies of the EU from an accrual accounting and budgetary perspective. It is the responsibility of the Commission's Accounting Officer to prepare the EU's consolidated annual accounts and ensure that they present fairly, in all material aspects, the financial position, the result of the operations and the cashflows of the EU institutions and bodies, including the European Medicines Agency (EMA), with a view to granting discharge. Discharge procedure: the final step of a budget lifecycle is the discharge of the budget for a given financial year. It represents the political aspect of the external control of budget implementation and is the decision by which the European Parliament, acting on a Council recommendation, "releases" the Commission (and other EU bodies) from its responsibility for management of a given budget by marking the end of that budget's existence. The European Parliament is the discharge authority within the EU. The discharge procedure may produce three outcomes: (i) the granting; (ii) postponement or; (iii) the refusal of the discharge. The final discharge report including specific recommendations to the Commission for action is adopted in plenary by the European Parliament and are subject to an annual follow up report in which the Commission outlines the concrete actions it has taken to implement the recommendations made. Each agency is subject to its own discharge procedure, including the European Medicines Agency (EMA). The European Medicines Agency: the Agency, which is located in London (UK), was created by Council Regulation (EEC) No 2309/93, which was replaced by Regulation (EC) No 726/2004 of the European Parliament and of the Council and its role is the coordination of the scientific resources made available by the national authorities in order to ensure the evaluation and supervision of medicinal products for human or veterinary use on the basis of a centralised procedure. As regards Agency’s accounts, these are presented in detail in the document on the consolidated annual accounts of the European Union for 2016: Commitment appropriations: available: EUR 314 million; made: EUR 301 million. Payment appropriations: available: EUR 347 million; made: EUR 294 million. For further details on expenditure, please refer to the final accounts of the EMA.
- DG {'url': 'http://ec.europa.eu/info/departments/budget_en', 'title': 'Budget'}, OETTINGER Günther
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COM(2017)0365
summary
Documents
- Non-legislative basic document published: COM(2017)0365
- Committee report tabled for plenary, single reading: A8-0103/2018
- Results of vote in Parliament: Results of vote in Parliament
- Debate in Parliament: Debate in Parliament
- Decision by Parliament, 1st reading/single reading: T8-0150/2018
| Amendments | Dossier |
| 32 |
2017/2154(DEC)
2017/12/13
ENVI
9 amendments...
Amendment 1 #
Draft opinion Paragraph 1 a (new) 1 a. Notes with regret the numerous criticisms of the Agency contained in the European Court of Auditors (ECA) Report on the annual accounts of the European Medicines Agency for the financial year 2016;notes also with regret the Agency's tepid response to those criticisms and recommends that it should be far more receptive of the constructive criticisms and recommendations offered by the Court, and act accordingly to take whatever corrective and preventative measures are necessary;
Amendment 2 #
Draft opinion Paragraph 2 2. Notes that in 2016 the total budget of the Agency was EUR 308 422 000; highlights that 89,4 % of the Agency’s revenue came from fees paid by the pharmaceutical industry for services provided, 5,5 % from the Union budget and 5 % from external assigned revenue; points out that the share of the Agency’s revenue that comes from fees paid by the pharmaceutical industry, which is now very high, should be accompanied by increased requirements regarding the Agency's independence from the pharmaceutical industry;
Amendment 3 #
Draft opinion Paragraph 2 a (new) 2a. Points out that the Agency monitors budget consumption through a robust monitoring process;
Amendment 4 #
Draft opinion Paragraph 5 5. Welcomes the launch of the clinical data website in October 2016, which represents an important step towards higher transparency; notes that the website gives open access to clinical reports for new medicines for human use authorised in the Union; notes that the Agency is the first regulatory authority worldwide to provide such broad access to clinical data; nevertheless encourages the Agency to continue this important work of providing information for the general public;
Amendment 5 #
Draft opinion Paragraph 6 6. Notes that the Agency set up a taskforce dedicated to ‘Brexit’, which in 2016 was focused on assessing the impact of Brexit on the Agency, with the aim of identifying the main risks, and propose possible mitigating measures; invites this taskforce to work constructively, and to take account of all the positive implications of Brexit for the functioning of the Agency;
Amendment 6 #
Draft opinion Paragraph 6 a (new) 6a. Notes that setting up a fully transparent reporting system is costly and complicated, owing to the complexity of the system and the significant number of transactions processed every year;
Amendment 7 #
Draft opinion Paragraph 7 a (new) 7 a. Is concerned that in the case of fee-funded agencies, like the Agency, the staff cuts imposed in recent years have meant a reduction in staff working on tasks that are actually funded by applicants' fees and not by the Union budget;that has been done without taking into consideration the extra workload created by increasing numbers of applications, nor the corresponding increase in income from fees paid by applicants for the services provided, which could have allowed staff increases without any impact on the Union budget;notes that the need for additional staff and budget resources will become particularly acute for the Agency during the 2018-2020 preparation and relocation phase to its new seat in Amsterdam, during which the Agency will have to continue fulfilling its key public health tasks as well as the additional tasks linked to the relocation itself;
Amendment 8 #
Draft opinion Paragraph 9 9. Stresses that the policy on the handling of competing interests of scientific committees' members and experts was updated in October 2016; notes that it includes a clarification on the restrictions regarding the expert's potential employment in a pharmaceutical company and aligns the rules relating to close family members' interests for scientific committee and working party members, with those for the Management Board members; nevertheless encourages the Agency further to strengthen its internal policy on combating conflicts of interest and its independence from the pharmaceutical industry;
Amendment 9 #
Draft opinion Paragraph 11 a (new) 11a. Notes that the Agency has been facing a significant risk of instability, owing to the unsuccessful process of reallocating key staff in the area of IT and administration;
source: 615.425
2018/03/02
CONT
23 amendments...
Amendment 1 #
Proposal for a decision 1 Paragraph 1 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
Amendment 10 #
Motion for a resolution Paragraph 16 a (new) 16 a. Acknowledges from the Agency that pre-submission meetings contribute to the development of medicines; notes that in the light of the pre-submission meetings, the experts of the Committee for Medicinal Products for Human Use perform both the role of consultant as of evaluator of the marketing authorisation applications; calls upon the Agency to at least publish a list of pre-submission activities, once the marketing authorisation has been given;
Amendment 11 #
Motion for a resolution Paragraph 16 b (new) 16 b. Acknowledges that approvals of marketing authorisation applications are based on three criteria: efficacy, quality and safety; notes that a fourth requirement should be added: Added Therapeutic Value (ATV), comparing a medicine with the best available drug, instead of comparing it to placebos;
Amendment 12 #
Motion for a resolution Paragraph 19 19. Notes with satisfaction that the CVs and declarations of interests of all Management Board members are published on the Agency's website; notes that no breach of trust procedures were initiated for Management Board members in 2016;
Amendment 13 #
Motion for a resolution Paragraph 20 a (new) 20 a. Asks the Agency for clarification concerning the hiring of and dependence on IT consultants for IT projects; notes that no methodology had been put in place prior to the start of the projects, affecting the supervision and monitoring by the management; is concerned about the limited supervision of the external consultants as a result of the contracts used and the fact that performance takes place off-site and in other Member States, resulting, therefore, in delays in the projects’ implementation;
Amendment 14 #
Motion for a resolution Paragraph 20 a (new) 20 a. Notes that the relocation of the Agency could lead to staff leaving the Agency; calls therefore on the Agency to make sure that revolving door rules are strictly applied in each case;
Amendment 15 #
Motion for a resolution Paragraph 22 22. Takes note that the Agency has adopted the Commission guidelines on internal whistleblowing in November 2014; welcomes the adoption by the Agency‘s Management Board of a policy to handle external sources’ reports on matters within the scope of its responsibilities (i.e. external whistleblowing rules) in March 2017; calls on the Internal Control Unit to perform random verifications in cooperation with heads of divisions to strengthen measures for detection of suspicious behaviors and deterrence; recommends that the Agency subjects its conflict of interest policies to an independent assessment;
Amendment 16 #
Motion for a resolution Paragraph 22 a (new) 22 a. Expresses the need to establish an independent disclosure, advice and referral body with sufficient budgetary resources, in order to help whistleblowers use the right channels to disclose their information on possible irregularities affecting the financial interests of the Union, while protecting their confidentiality and offering needed support and advice;
Amendment 17 #
Motion for a resolution Paragraph 23 23. Acknowledges from the Agency that in 2016, it recorded no internal whistleblower case
Amendment 18 #
Motion for a resolution Paragraph 24 24. Notes that in 2016 the Agency received 823 requests for access to documents which represent a 20 % increase compared to 2015; notes that the Agency replied to 678 requests and granted full access to 542 requests, 17 requests were granted only partial access and 44 requests were refused; notes that the reason given by the Agency for refusing 21 requests to access to documents was the protection of commercial interests; calls on the Agency to ensure that, when deciding on limiting the access to documents due to protection of commercial interests, it also considers the Union and its citizens’ interest in health with
Amendment 2 #
Proposal for a decision 1 Paragraph 1 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
Amendment 20 #
Motion for a resolution Paragraph 30 30. Notes in particular that the Agency will be facing an additional workload and budgetary needs throughout the 2018-2020 relocation and transition period as a consequence of the decision of the United Kingdom (UK) to withdraw from the Union; calls on the Commission to make available ad
Amendment 21 #
Motion for a resolution Paragraph 31 a (new) 31 a. Welcomes the Parliament's mission to Amsterdam, at the temporary and future headquarters of the Agency, to gather up-to-date information on the progress of the double transfer and on the development of the real estate project and underlines the role of the Parliament in the decision-making process regarding the new headquarters;
Amendment 22 #
Motion for a resolution Paragraph 33 33. Notes that the Court issued an emphasis of matter paragraph for the two London-based agencies, concerning the UK’s decision to withdraw from the Union; notes that in view of the decisions on the future location of the Agency, it has disclosed in its financial statements an estimated EUR 448 000 000 rent for the remaining rental period between 2017 and 2039 as a contingent liability, as the rental contract does not include any exit clause; urges the Commission to take responsibility of these absurdly high liabilities and, together with the Agency, negotiate an acceptable deal with the lessor; notes moreover that contingent liabilities in relation to other costs associated with a removal such as, for example the relocation of staff together with their families, actions to mitigate a potential loss of internal and UK-based external expertise, and consequent risk to business continuity, are yet to be determined; calls on the Agency to report to the discharge authority on an updated estimate of relocation costs, which includes liability of the current premises;
Amendment 23 #
Motion for a resolution Paragraph 34 34. Points out from the Court’s report that the Agency’s 2016 budget was financed 95 % by fees from pharmaceutical companies and 5 % from Union funds;
Amendment 3 #
Proposal for a decision 1 Paragraph 1 1.
Amendment 4 #
Proposal for a decision 2 Paragraph 1 1. Approves the closure of the accounts of the European Medicines Agency for the financial year
Amendment 5 #
Motion for a resolution Paragraph 2 2. Notes that, according to the Court’s report, since the introduction of a new IT accounting system in 2011, reporting on commitment workflow and consumption has not been sufficiently transparent; regrets that, although the matter was repeatedly raised with the Agency, no corrective action has been taken; take note of the Agency's explanation that "[the Agency] is currently working to increase the reporting functionality of its financial system, in line with the recommendations by the Court"; calls on the Agency to implement corrective actions as soon as possible in 2018 and to report to the discharge authority on their implementation;
Amendment 6 #
Motion for a resolution Paragraph 3 3. Notes with concern that, according to the Court’s report, the Agency concluded corporate rate agreements for the provision of accommodation for experts with 25 hotels in London without using a competitive procurement procedure; notes that for six hotels, payments made in 2016 were above the Financial Regulation’s threshold for which an open or restricted competitive procurement procedure is required;
Amendment 7 #
Motion for a resolution Paragraph 9 9. Regrets that, as regards the number of posts occupied on 31 December 2016 for all staff (including contract agents), gender balance
Amendment 8 #
Motion for a resolution Paragraph 14 14. Notes that, according to the Court’s report, since 2014 the Agency has undergone two major re-organisations including the internal re-allocation of top and middle management positions; notes moreover that the re-allocation of key staff in the area of IT and administration was not successful, causing material risk of instability to the Agency and its operations; notes however that the Agency considers that no instability was suffered by the Agency due to organisational changes which aimed at increasing operational efficiencies and improving delivery of strategic objectives and which were supported by the Agency’s Management Board; notes moreover that there is no system in place to analyse skills availability, identify gaps and to recruit and allocate appropriate staff; calls on the Agency to pay extra attention to these issues, improve its human resources management and report back to the discharge authority;
Amendment 9 #
Motion for a resolution Paragraph 16 16. Notes that, according to the Court’s report, in 2014 the Commission, on behalf of more than 50 Union Institutions and bodies (including the Agency) signed a framework contract with one contractor for the acquisition of software, licences and the provision of related IT maintenance and consultancy; notes that the framework contractor acts as an intermediary between the Agency and suppliers that can address the Agency’s needs; takes note that for these intermediary services, the framework contractor is entitled to a commission of two to nine percent of the suppliers’ prices; observes that in 2016, total payments to the framework contractor amounted to EUR 8 900 000; regrets that the Agency did not systematically check prices and uplifts charged with the suppliers’ quotes and invoices issued to the framework contractor;
source: 618.255
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