# L_2020417EN.01046401.xml

| 11.12.2020 | EN | Official Journal of the European Union | L 417/464 |
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11.12.2020

EN

Official Journal of the European Union

L 417/464

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RESOLUTION (EU) 2020/1983 OF THE EUROPEAN PARLIAMENT

of 14 May 2020

with observations forming an integral part of the decision on discharge in respect of the implementation of the budget of the European Medicines Agency (EMA) for the financial year 2018

THE EUROPEAN PARLIAMENT,

| — | having regard to its decision on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2018, |
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having regard to its decision on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2018,

| — | having regard to Rule 100 of and Annex V to its Rules of Procedure, |
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having regard to Rule 100 of and Annex V to its Rules of Procedure,

| — | having regard to the opinion of the Committee on the Environment, Public Health and Food Safety, |
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having regard to the opinion of the Committee on the Environment, Public Health and Food Safety,

| — | having regard to the report of the Committee on Budgetary Control (A9-0076/2020), |
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having regard to the report of the Committee on Budgetary Control (A9-0076/2020),

| A. | whereas, according to its statement of revenue and expenditure (1), the final budget of the European Medicines Agency (the ‘Agency’) for the financial year 2018 was EUR 337 761 000, representing an increase of 1,96 % compared to 2017; whereas the Agency is a fee-funded agency, with 90 % of its 2018 revenue stemming from fees paid by the pharmaceutical industry for services provided, and 10 % stemming from the Union budget (2); |
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A.

whereas, according to its statement of revenue and expenditure (1), the final budget of the European Medicines Agency (the ‘Agency’) for the financial year 2018 was EUR 337 761 000, representing an increase of 1,96 % compared to 2017; whereas the Agency is a fee-funded agency, with 90 % of its 2018 revenue stemming from fees paid by the pharmaceutical industry for services provided, and 10 % stemming from the Union budget (2);

| B. | whereas the Court of Auditors (the ‘Court’) in its report on the annual accounts of the Agency for the financial year 2018 (the ‘Court’s report’), states that it has obtained reasonable assurances that the Agency’s annual accounts are reliable and that the underlying transactions are legal and regular; |
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B.

whereas the Court of Auditors (the ‘Court’) in its report on the annual accounts of the Agency for the financial year 2018 (the ‘Court’s report’), states that it has obtained reasonable assurances that the Agency’s annual accounts are reliable and that the underlying transactions are legal and regular;

Budget and financial management

| 1. | Notes with concern that budget monitoring efforts during the financial year 2018 resulted in a budget implementation rate of 89,14 %, representing a decrease of 1,91 % compared to 2017; notes furthermore that the payment appropriations execution rate was 73,64 %, representing a decrease of 2,98 % compared to 2017; calls on the Agency to improve its budget implementation and payment appropriations execution rate; |
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1.

Performance

| 2. | Acknowledges that the Agency continues to use several key performance indicators, including a combination of operational, management/governance and communication/stakeholder indicators to measure its workload volumes, its work programme implementation and its stakeholder satisfaction, in order to assess the added value provided by its activities, and that it furthermore uses budget planning and monitoring methodology to enhance its budget management; |
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2.

| 3. | Notes with concern that EudraVigilance, an information system used to report suspected side effects of medicines, and other telematics projects had to be postponed or reduced due to the United Kingdom’s decision to withdraw from the European Union; however, acknowledges that the Agency reassures that the projects and activities under the Brexit preparedness business continuity plan were carried out in a way which did not affect the functioning of the safety monitoring system for medicines in the Union and allowed all parties involved (industry, the Agency and national competent authorities) to continue complying with their legal obligations under the Union pharmaceutical legislation; |
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3.

| 4. | Notes that the Agency cooperates with other agencies on joint scientific outputs and exchanges support or scientific data; acknowledges furthermore that the Agency continues to have formal working arrangements with its four main agency partners; |
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4.

| 5. | Notes that in the context of the implementation of the EU Telematics strategy for the European medicines regulatory network, major milestones were achieved by the network, but some activities were reduced due to preparations for the Agency’s relocation and the consequent increased consumption of resources in other areas of IT; |
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5.

| 6. | Notes with concern that, according to the Court’s report, the Agency has made excessive use of consultancy services for its two main IT projects, making it critically dependent on external expertise and leading to disproportionate cost overruns and delays; notes that the Agency started the implementation of mitigating measures in 2017, which, however, are not yet fully effective, as evidenced, for instance, by what is still an excessively high number of consultants working on the basis of Time and Means contracts; calls on the Agency to speed up the implementation of mitigating actions not only for the completion of the ongoing IT projects, but also to get ready for significant new projects; |
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6.

| 7. | Encourages the Agency to pursue the digitalisation of its services; |
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7.

| 8. | Notes that the Court has identified a horizontal trend across agencies in the use of external staff hired in IT consultancy roles; calls for the dependency on external recruitment in this important and sensitive area to be reduced as much as possible in order to limit any potential risks; |
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8.

| 9. | Reiterates the important role of the Agency in protecting and promoting public and animal health by assessing and supervising medicines for human or veterinary use; |
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9.

| 10. | Highlights the fact that in 2018, the Agency recommended 94 new medicines for marketing authorisation (84 for human use and 10 for veterinary use), and that those included 46 new active substances (42 for human use and 4 for veterinary use); notes that in 2018, in the framework of its pharmacovigilance activities, the Agency recommended the immediate suspension of the sale of and recall of a medicine for multiple sclerosis due to it causing serious and sometimes fatal immune reactions, and the suspension of the sale of several antibiotics; |
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10.

| 11. | Notes that in 2018 the second and third phases of the business continuity plan were implemented, in order to safeguard the core activities of the Agency; stresses, in this respect, the need to ensure maximum transparency, expertise and independence in the Agency’s work; |
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11.

| 12. | Is concerned about the delays observed in the development of the EU clinical trials portal and database; draws attention, in that connection, to the need to resolve the problems with regard to the Agency’s IT infrastructure, which is under heavy strain; |
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12.

| 13. | Points out that the Agency’s data centre was successfully moved to Hamburg in 2018; |
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13.

Staff policy

| 14. | Notes that, on 31 December 2018, the establishment plan was 98,31 % executed, with 581 temporary agents appointed out of 591 temporary agents authorised under the Union budget (compared with 596 authorised posts in 2017); notes that in addition 170 contract agents and 30 seconded national experts worked for the Agency in 2018; |
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14.

| 15. | Notes that further efforts are needed for achieving an even gender balance among senior managers (in 2018: 17 men and 11 women) and the management board members (20 men and 13 women); |
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15.

| 16. | Notes that the Agency has an employees’ assistance programme in place, which is a support programme offered free of charge to its staff; notes furthermore that the Agency has a policy on providing support to staff subject to external accusations and attacks; |
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16.

| 17. | Notes with concern that, according to the Agency and to the Court’s report, while significant new tasks were assigned to the Agency, the Agency’s staff establishment plan was not increased; notes the measures already taken by the Agency to mitigate the risks involved, such as the cost-neutral recruitment of time-limited contract agents; regrets that, according to the Court’s report, those measures are not yet fully effective; |
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17.

| 18. | Notes that the Agency now complies with the Court’s recommendation of 2017 to publish vacancy notices, not only on its website and the Union Agencies’ websites but also, with a view to getting more publicity, on the website of the European Personnel Selection Office; |
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18.

Procurement

| 19. | Notes that the Agency had in the past introduced e-tendering for its procurement procedures; notes with satisfaction that the e-submission tool has now also been successfully implemented and is in use since early 2019; notes that, according to the Agency’s reply, it is now working on implementing the e-invoicing tool; |
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19.

Prevention and management of conflicts of interests and transparency

| 20. | Stresses that the Agency’s clients – pharmaceutical industry companies – pay for the procedure, not for the outcome of the Agency’s assessments; understands that, according to the Agency, its recommendations are made independently and therefore do not create conflicts of interest; notes with satisfaction that the Agency ensures that its scientific committee members and experts, staff and management board members, do not have any financial or other interests in the pharmaceutical industry; |
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20.

| 21. | Recalls that the Agency is a fee-funded agency, with 89,69 % of its 2018 revenue stemming from fees paid by the pharmaceutical industry, 10,28 % stemming from the Union budget and 0,03 % stemming from external assigned revenue; is concerned that the high reliance on fees from industry may compromise the public perception of the Agency’s independence; |
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21.

| 22. | Acknowledges the Agency’s existing measures and ongoing efforts to secure transparency, prevent and manage conflicts of interest, and provide whistleblower protection; is highly concerned that, in 2018, the Agency received 21 reports on cases of whistleblowing from an external source raising the problem of maladministration at the Agency, 5 of which were closed in 2017 and 17 cases are still ongoing; calls on the Agency to address the cases and the problems as a matter of urgency and report to the discharge authority on any developments in that regard; welcomes that the Agency has in place a declaration of conflict of interest for management board members, for senior management and for experts and makes it available online; |
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22.

| 23. | Welcomes that, in February 2018, the General Court of the European Court of Justice upheld, in three landmark judgments (Cases T-235/15, T-718/15 and T-729/15 (3)), the Agency’s decision to release documents in accordance with Regulation (EC) No 1049/2001 of the European Parliament and of the Council (4); |
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23.

| 24. | Welcomes that, on 22 January 2020, the Court of Justice upheld the Agency’s policy of access to documents in its appeal rulings in T-235/15 and T-718/15; |
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24.

| 25. | Notes that the Agency meets with interest representatives and has rules in place to govern its interactions with stakeholders, and furthermore that it continues to publish the minutes of meetings with interest representatives on its website; notes that the Agency continues to implement a framework for stakeholder relation management, in consultation with the Commission, which encompasses transparency measures; |
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25.

| 26. | Notes that, in light of the comments and observations made by the discharge authority relating to the need to strengthen the accounting officer’s independence by making him or her directly responsible to the Agency’s director and management board, the Agency is currently reviewing the accounting officer’s reporting line as one more measure aimed at further strengthening the accounting officer’s independence; furthermore, welcomes that the overall conclusion of the validation exercise of the accounting systems ran by the accounting officer with an external audit firm was positive; |
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26.

Internal audit

| 27. | Notes that following the Commission’s Internal Audit Service’s audit of the Agency’s ‘Implementation of the pharmacovigilance fees Regulation’, in which the ongoing deficit between income from some pharmacovigilance fees and the related costs was highlighted, a revision of Regulation (EU) No 658/2014 of the European Parliament and of the Council (5) is currently being prepared by the Commission; notes that the Agency continues to participate actively in the Commission’s review of the economic basis for the entire Agency fee system and that new provisions regarding fees are expected to come into force in January 2022; understands that the Agency sent the status of implementation of actions to the Commission’s Internal Audit Service in July 2019; calls on the Agency to report to the discharge authority on the actions taken in this regard; |
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27.

Ombudsman recommendations

| 28. | Notes that in its inquiry on how the Agency engages with medicine developers in the period leading up to applications for authorisations to market new medicines in the Union, the European Ombudsman suggested the Agency should introduce improvements to:






  — | ensure that there is a separation between those responsible for providing scientific advice to a medicine developer and those subsequently involved in evaluating a market authorisation application for the same medicine; |
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28.

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ensure that there is a separation between those responsible for providing scientific advice to a medicine developer and those subsequently involved in evaluating a market authorisation application for the same medicine;

| — | take into account whether individuals were already involved as coordinators in providing advice on the same medicine in the pre-submission phase when appointing rapporteurs to evaluate market authorisation applications; |
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take into account whether individuals were already involved as coordinators in providing advice on the same medicine in the pre-submission phase when appointing rapporteurs to evaluate market authorisation applications;

| — | document and publish the reasons for its decision to appoint as a rapporteur an expert who had a prominent role in providing advice for the same medicine during the pre-submission phase; |
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document and publish the reasons for its decision to appoint as a rapporteur an expert who had a prominent role in providing advice for the same medicine during the pre-submission phase;

| — | ensure that at least one of the two rapporteurs had no prominent role in the pre-submission phase concerning that medicine; |
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ensure that at least one of the two rapporteurs had no prominent role in the pre-submission phase concerning that medicine;

| — | attach to the European public assessment report a detailed log of all relevant activities during the pre-submission phase, including the names of the experts involved; |
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attach to the European public assessment report a detailed log of all relevant activities during the pre-submission phase, including the names of the experts involved;

Other comments

| 29. | Notes that the Court issued an emphasis of matter paragraph in relation to the two London-based agencies, concerning the United Kingdom’s decision to withdraw from the European Union; notes that the seat of the Agency moved to Amsterdam in March 2019 and that the Agency’s accounts at 31 December 2018, included provisions for related costs amounting to EUR 17 800 000; regrets that the lease agreement for the London-based premises sets a rental period until 2039 with no exit clause; also regrets that on 20 February 2019, the High Court of Justice of England and Wales ruled against the Agency’s request to cancel the lease; notes, however, that the lease agreement allows reassignment or subletting of the premises to third parties, subject to the landlord’s consent; deeply regrets that the notes to the accounts at 31 December 2018 disclosed an amount of EUR 468 000 000 remaining rent until 2039, of which an amount of EUR 465 000 000 for the lease period after the Agency’s planned move to Amsterdam is disclosed as a contingent liability; recognises the Agency’s significant efforts to find a subtenant for its London premises; highlights that although a sublease of the premises was concluded by the Agency with effect from 1 July 2019, the future net cost of the lease agreement being uncancellable is unknown; urges the Commission to do its utmost to minimise the long-term financial, administrative and operational impact on the Agency of the unfavourable lease agreement; calls on the Agency to involve the Commission, in particular the legal service and the negotiating team acting in relation to the United Kingdom’s decision to withdraw from the European Union, in an examination of the legal problem since it raises the legal and financial responsibility of the government of the United Kingdom for invoking Article 50 of the Treaty on European Union, a situation which the High Court did not recognise as a matter of force majeure; calls on the Agency to report back to the discharge authority on the matter; |
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29.

| 30. | Is concerned that the Agency, being a Union public health agency, will have to manage commercial property in a third country and will remain liable for paying rent until June 2039; requests that solutions to release the Agency from its contractual and financial liabilities in respect of its former United Kingdom premises are sought in the ongoing negotiations between the Union and the United Kingdom if the latter’s responsibility cannot be established; |
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30.

| 31. | Notes that the Agency worked closely with the Commission and the network to ensure an orderly redistribution of the work so far carried out by the United Kingdom; notes that the Agency successfully managed to move to Amsterdam with the aim of retaining its existing staff to the highest degree possible, and also to move its data centre to Hamburg; notes that the seat agreement between the Netherlands and the Agency was signed on 1 July 2018; |
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31.

| 32. | Notes that, according to the Agency, significant resources and new tasks had to be redistributed following the relocation to Amsterdam, with the consequent loss of short-term contract staff combined with a reduction of 10 % of the Agency’s establishment plan imposed since 2014 and an increased workload; notes the Agency’s concern that a shortage of human resources may put the fulfilment of its core and legislative responsibilities at risk; calls upon the Agency to research the possibility of sharing of resources on overlapping tasks among other agencies with similar activities, including sharing of staff; strongly encourages the Agency to actively seek further and broader cooperation with all of the Union agencies; |
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32.

| 33. | Calls on the Agency to focus on disseminating the results of its research to the public, and to reach out to the public via social media and other media outlets; |
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33.

| 34. | Refers, for other observations of a cross-cutting nature accompanying its decision on discharge, to its resolution of 14 May 2020 (6) on the performance, financial management and control of the agencies. |
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34.

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(1)  OJ C 108, 22.3.2018, p. 26.

(2)  OJ C 108, 22.3.2018, p. 28.

(3)  Judgments of the General Court of 5 February 2018, Pari Pharma v EMA, T-235/15 ECLI:EU:T:2018:65, 5 February 2018, PTC Therapeutics International v EMA, T-718/15 ECLI:EU:T:2018:66, and 5 February 2018, MSD Animal Health Innovation and Intervet international v EMA, T-729/15, ECLI:EU:T:2018:67.

(4)  Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).

(5)  Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (OJ L 189, 27.6.2014, p. 112).

(6)  Texts adopted, P9_TA(2020)0121.

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