Activites

• 2017/04/27 Results of vote in Parliament
  • Results of vote in Parliament
  • T8-0172/2017 summary

    The European Parliament decided to grant discharge to the Executive Director of the European Medicines Agency (EMA) in respect of the implementation of the budget of Agency for the financial year 2015. The vote on the decision on discharge covers the closure of the accounts (in accordance with Annex IV, Article 5 (1) (a) to Parliament’s Rules of Procedure). Noting that the Court of Auditors has stated that it has obtained reasonable assurances that the Agency’s annual accounts for the financial year 2015 are reliable and that the underlying transactions are legal and regular, Parliament adopted by 510 votes to 101 with 13 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. These recommendations may be summarised as follows: Agency’s financial statements: Parliament noted the final budget of the European Medicines Agency for the financial year 2015 was EUR 308 097 000 representing an increase of 9.07 % compared to 2014. Prevention and management of conflicts of interests and transparency: It acknowledged that the revised policy on the handling of declarations of interests of scientific committees’ members and experts entered into force in 2015. Parliament also made a series of observations regarding the budgetary and financial management, commitments and carry-overs, transfers, procurement and recruitment procedures, the prevention and management of conflicts of interests and internal audits and controls. Communication: Parliament noted that in 2015, the Agency recommended 93 medicines for marketing authorisation and that those include 39 new active substances. It stressed that those substances have previously never been authorised in a medicine in the Union and are not related to the chemical structure of any other authorised substance. Parliament reminded the Agency that Directive 2003/63/EC states that medicines can only be considered for Union marketing authorisation if they have been tested in accordance with ethical guidelines, and reminded the Agency of its commitment to perform extra checks on clinical trials carried out outside the European Union before granting a drug market authorisation. Therefore, due to the special vulnerabilities of those tests, Parliament asked the Agency to report to the discharge authority every year on actions taken to ensure drugs for the Union market were tested ethically in lower and middle income countries, in accordance with the law. It underlined that the Agency should continue promoting dialogue with stakeholders and citizens and incorporate it as part of the priorities and activities to be implemented. Adaptive pathways: Parliament noted that the Agency launched a pilot project on "adaptive pathways" in March 2014 aiming to accelerate market authorisations for specific medicines using the so-called post-marketing authorisation. It is concerned that the pilot project raises numerous public health concerns and undermines the core mission of the Agency, namely to ensure safety of medicines. It asked the Agency to report to the discharge authority on the project and the measures it has taken to ensure that this acceleration of the procedure does not undermine its core mission. Impact of Brexit: Parliament stated that on 23 June 2016, the citizens of the United Kingdom voted to leave the European Union. It noted that following the outcome of the UK referendum on 23 June 2016, the Agency established a dedicated task force to focus on relocation preparedness, operational and financial preparedness, HR-related matters and communication (internal and external) aspects. It observed that the work currently ongoing is focussed on the impact of a loss of EMA staff in the event of relocation and loss of external expertise due to the potential unavailability of UK expertise in the scientific committees and other EMA fora. An impact assessment including remedial solutions should be available by the end of the first quarter of 2017. Lastly, Parliament noted with concern that the Agency’s rental contract until 2039 does not include an early termination clause to release the Agency from the liabilities of rent and associated costs, and that the payable rent for the remaining period from 2017 to 2039 is estimated at EUR 347.6 million. It asked the Agency to report to the discharge authority on any developments on this matter.

• 2017/04/26 Debate in Parliament
  • Debate in Parliament
• 2017/03/28 Committee report tabled for plenary, single reading
  • A8-0084/2017 summary

    The Committee on Budgetary Control adopted the report by Inés AYALA SENDER (S&D, ES) on discharge in respect of the implementation of the budget of the European Medicines Agency (EMA) for the financial year 2015. 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 2015. Noting that the Court of Auditors stated that it had obtained reasonable assurance that the annual accounts of the Agency for the financial year 2015 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: Members note the final budget of the European Medicines Agency for the financial year 2015 was EUR 308 097 000 representing an increase of 9.07 % compared to 2014. Prevention and management of conflicts of interests and transparency: Members acknowledged that the revised policy on the handling of declarations of interests of scientific committees’ members and experts entered into force in 2015. They reminded the Agency that Directive 2003/63/EC states that medicines can only be considered for Union marketing authorisation if they have been tested in accordance with ethical guidelines. They also reminded it of its commitment to perform extra checks on clinical trials carried out outside the European Union before granting a drug market authorisation. The Agency is asked to report to the discharge authority every year on actions taken to ensure drugs for the Union market were tested ethically. Members also made a series of observations regarding the budgetary and financial management, commitments and carry-overs, transfers, procurement and recruitment procedures, the prevention and management of conflicts of interests and internal audits and controls. Impact of Brexit: on 23 June 2016, the citizens of the United Kingdom voted to leave the European Union. Members noted that following the outcome of the UK referendum on 23 June 2016, the Agency established a dedicated task force to focus on relocation preparedness, operational and financial preparedness, HR-related matters and communication (internal and external) aspects. They observed that the work currently ongoing is focussed on the impact of a loss of EMA staff in the event of relocation and loss of external expertise due to the potential unavailability of UK expertise in the scientific committees and other EMA fora. An impact assessment including remedial solutions should be available by the end of the first quarter of 2017. Lastly, Members noted with concern that the Agency’s rental contract until 2039 does not include an early termination clause to release the Agency from the liabilities of rent and associated costs, and that the payable rent for the remaining period from 2017 to 2039 is estimated at EUR 347.6 million. They asked the Agency to report to the discharge authority on any developments on this matter.

• 2017/03/22 Vote in committee, 1st reading/single reading
• 2016/10/04 Committee referral announced in Parliament, 1st reading/single reading
• 2016/07/11 Non-legislative basic document published
  • COM(2016)0475 summary

    PURPOSE: presentation by the Commission of the consolidated annual accounts of the European Union for the financial year 2015, as part of the 2015 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. The EU's operational expenditure of these institutions takes different forms, depending on how the money is paid out and managed. From 2014 onwards, the Commission classifies its expenditure as follows: Direct management: the budget is implemented directly by the Commission services. Indirect management: the Commission confers tasks of implementation of the budget to bodies of EU law or national law, such as the EU agencies. Shared management: under this method of budget implementation tasks are delegated to Member States. About 80 % of the expenditure falls under this management mode covering such areas as agricultural spending and structural actions. This Commission document concerns the EU's consolidated accounts for the year 2015 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 2015: Commitment appropriations: -          committed: EUR 308 million; -          paid: EUR 290 million; -          carried-over: EUR 6 million. Payment appropriations: -          committed: EUR 349 million; -          paid: EUR 291 million; -          carried-over: EUR 43 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'}, GEORGIEVA Kristalina

Documents

• Non-legislative basic document published: COM(2016)0475
• Committee report tabled for plenary, single reading: A8-0084/2017
• Debate in Parliament: Debate in Parliament
• Results of vote in Parliament: Results of vote in Parliament
• Decision by Parliament, 1st reading/single reading: T8-0172/2017

History

(these mark the time of scraping, not the official date of the change)