Awaiting Parliament 1st reading / single reading / budget 1st stage
Next event: Vote in plenary scheduled 2017/04/27 more...
- Vote in committee, 1st reading/single reading 2017/03/22
- Committee report tabled for plenary, single reading 2017/03/28
- Debate in Parliament 2017/04/26
Role | Committee | Rapporteur | Shadows |
---|---|---|---|
Lead | CONT | AYALA SENDER Inés (S&D) | ZDECHOVSKÝ Tomáš (EPP), FITTO Raffaele (ECR), ALI Nedzhmi (ALDE), DE JONG Dennis (GUE/NGL), JÁVOR Benedek (Verts/ALE), VALLI Marco (EFD), KAPPEL Barbara (ENF) |
Opinion | ENVI | LA VIA Giovanni (EPP) |
Activites
-
2017/04/27
Vote in plenary scheduled
-
2017/04/26
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.
-
A8-0084/2017
summary
-
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
-
COM(2016)0475
summary
Documents
- Non-legislative basic document published: COM(2016)0475
- Committee report tabled for plenary, single reading: A8-0084/2017
Amendments | Dossier |
24 |
2016/2169(DEC)
2016/12/14
ENVI
24 amendments...
Amendment 1 #
Draft opinion Paragraph 1 1. Recalls that, as stipulated in its financial regulation, budget revenue of the European Medicines Agency ('the Agency') is based on cash received for contributions from the Union, fees for circulation and marketing authorisation applications for pharmaceutical products and for post- authorisation activities as well as for various administrative activities;
Amendment 10 #
Draft opinion Paragraph 6 a (new) 6a. Calls on the Agency to pay special attention to the protection of whistleblowers in the context of Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure1 a; _________________ 1a OJ L 157, 15.6.2016, p. 1.
Amendment 11 #
Draft opinion Paragraph 6 b (new) 6b. Calls for an overall improvement in the prevention of, and the fight against, corruption through a holistic approach, commencing with better public access to documents and more stringent rules on conflicts of interest, the introduction or strengthening of transparency registers and the provision of sufficient resources for law enforcement measures, and also through improved cooperation among Member States and with relevant third countries;
Amendment 12 #
Draft opinion Paragraph 6 c (new) 6c. Encourages the Agency further to raise awareness of the conflict-of-interest policy among its staff, alongside ongoing awareness-raising activities and the inclusion of integrity and transparency as an obligatory item to be discussed during recruitment procedures and performance reviews;
Amendment 13 #
Draft opinion Paragraph 7 7. Notes that in 2015 the Agency recommended 93 medicines for marketing authorisation and that those include 39 new active substances; stresses 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 substance authorised
Amendment 14 #
Draft opinion Paragraph 7 7.
Amendment 15 #
Draft opinion Paragraph 7 a (new) 7 a. Notes that the Agency launched a pilot project on "adaptive pathways" in March 2014; recalls that that project aims to accelerate marketing approvals for some specific medicines but raises numerous public health concerns; by shifting the burden of evidence from pre- marketing to post-marketing authorisation, the procedure in that pilot project can undermine the safety assessment of medicines; recalls that assessment of acceleration of authorisations in the United States has shown that more medicines were withdrawn once they had been put on the market, while the French independant medicine "Journal Prescrire" reported that, since 2006, 27% of the medicines authorised through an accelerated procedure in the Union were "unacceptable"1a _________________ 1a (Prescrire, april 2016, n°390, p.295)
Amendment 16 #
Draft opinion Paragraph 7 a (new) 7 a. Underlines that the Agency should continue promoting dialogue with stakeholders and citizens and incorporate it as part of the priorities and activities to be implemented;
Amendment 17 #
Draft opinion Paragraph 7 b (new) 7 b. Recommends the Agency to develop impact indicators; believes that such impact indicators are essential tools in order to measure the effectiveness of the Agency;
Amendment 18 #
Draft opinion Paragraph 8 8. 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, and emphasises, in that connection, that the Agency must pay close attention to the findings of independent and reliable scientific analyses and that a failure to do so may give rise to serious risks to public health in the EU;
Amendment 19 #
Draft opinion Paragraph 8 8. Reiterates the
Amendment 2 #
Draft opinion Paragraph 2 2. Notes that in 2015 the total budget of the Agency was EUR 304 000 000, of which only EUR 18 669 000 had been made available through the core funding directly from the general budget of the European Union;
Amendment 20 #
Draft opinion Paragraph 8 a (new) 8 a. Recalls that the workload of the Agency is constantly growing and reflected in the budgetary increases in income from fees charged to applicants; notes with concern that the imposed staff cuts in recent years included staff working on tasks financed by applicants' fees without regard to the workload involved; strongly supports, therefore, the introduction of flexibility in adjusting the number of establishment plan posts for staff working on tasks financed by applicants' fees, in line with increasing demand;
Amendment 21 #
Draft opinion Paragraph 8 a (new) 8a. Emphasises, in that connection, that the failure to take account of independent scientific analyses seems to have been glaring in the case of vaccines against the papilloma virus and their undesirable side effects;
Amendment 22 #
Draft opinion Paragraph 8 b (new) 8 b. Stresses the risk of budgetary volatility faced by the Agency as a consequence of the outcome of the UK referendum on Union membership; proposes, in the spirit of sound financial management, that the Agency be authorised to maintain a budgetary reserve to respond to unforeseen costs and unfavourable exchange rate fluctuation that may need to be incurred in 2017, or beyond, as a consequence of that decision, to ensure that the Agency can continue to carry out its tasks effectively;
Amendment 23 #
Draft opinion Paragraph 8 c (new) 8 c. Acknowledges that the Agency launched a pilot project in March 2014 on the safe use of adaptive pathways; notes that that pilot project aims to identify the appropriate tools within the current regulatory framework to bring to market medicines that address unmet medical needs for a defined patient population, and to ensure that marketing authorisation will only be granted if there is a positive balance of benefits and risks, without compromising patient safety or changing the standards of regulatory approval;
Amendment 24 #
Draft opinion Paragraph 9 9. Recommends, on the basis of the facts available,
Amendment 3 #
Draft opinion Paragraph 2 a (new) 2a. Emphasises, in that connection, that the significant share of its budget drawn from private sources raises the question of the independence of the Agency vis-à-vis the pharmaceutical industry;
Amendment 4 #
Draft opinion Paragraph 2 a (new) 2 a. Notes that the budget of EMA does not allow the Agency to have experts fully independent from the pharmaceutical industry;
Amendment 5 #
Draft opinion Paragraph 2 b (new) 2 b. Notes that several experts of the Agency still have links with the pharmaceutical industry, notably through grants;
Amendment 6 #
Draft opinion Paragraph 2 c (new) 2 c. Notes that the conflict of interests' policy of the Agency still needs to be improved, despite its 2015 reform; notes furthermore that revolving doors are not prevented since there is no cooling-off period for experts receiving grants from the private sector before joining the Agency and after leaving it;
Amendment 7 #
Draft opinion Paragraph 3 3.
Amendment 8 #
Draft opinion Paragraph 3 a (new) 3a. Emphasises that Brexit constitutes a new challenge for the Agency, which will have to cope with a change of seat that will necessitate many decisions concerning the management of its staff;
Amendment 9 #
Draft opinion Paragraph 4 a (new) 4a. Calls on the Agency to enhance its procedures and practices aimed at safeguarding the financial interests of the Union and to actively contribute to a results-oriented discharge process;
source: 595.702
|
History
(these mark the time of scraping, not the official date of the change)
activities/4/type |
Old
Debate in plenary scheduledNew
Debate in Parliament |
activities/3/docs/0/text |
|
activities/3/docs |
|
activities/4/type |
Old
Indicative plenary sitting date, 1st reading/single readingNew
Debate in plenary scheduled |
activities/5 |
|
activities/3 |
|
procedure/stage_reached |
Old
Awaiting committee decisionNew
Awaiting Parliament 1st reading / single reading / budget 1st stage |
activities/2/committees |
|
activities/2/type |
Old
Vote scheduled in committee, 1st reading/single readingNew
Vote in committee, 1st reading/single reading |
activities/3 |
|
activities/2/date |
Old
2017-03-23T00:00:00New
2017-03-22T00:00:00 |
activities/0/docs/0/celexid |
CELEX:52016DC0475:EN
|
activities/0/docs/0/celexid |
CELEX:52016DC0475:EN
|
activities/0/commission/0/DG/url |
Old
http://ec.europa.eu/dgs/budget/New
http://ec.europa.eu/info/departments/budget_en |
activities/1/committees/0/shadows/6/mepref |
Old
53b2d70eb819f205b0000008New
53b2dbc9b819f205b0000096 |
activities/1/committees/0/shadows/6/name |
Old
ALIOT LouisNew
KAPPEL Barbara |
committees/0/shadows/6/mepref |
Old
53b2d70eb819f205b0000008New
53b2dbc9b819f205b0000096 |
committees/0/shadows/6/name |
Old
ALIOT LouisNew
KAPPEL Barbara |
other/0/dg/url |
Old
http://ec.europa.eu/dgs/budget/New
http://ec.europa.eu/info/departments/budget_en |
activities/0/docs/0/text |
|
activities/1 |
|
activities/2/committees |
|
activities/2/date |
Old
2016-10-04T00:00:00New
2017-03-23T00:00:00 |
activities/2/type |
Old
Committee referral announced in Parliament, 1st reading/single readingNew
Vote scheduled in committee, 1st reading/single reading |
committees/0/shadows/0 |
|
committees/0/shadows/1 |
|
committees/0/shadows/2 |
|
committees/0/shadows/4 |
|
committees/0/shadows/5 |
|
committees/0/shadows/6 |
|
activities/1 |
|
procedure/dossier_of_the_committee |
CONT/8/07467
|
procedure/stage_reached |
Old
Preparatory phase in ParliamentNew
Awaiting committee decision |
activities/0/commission/0 |
|
other/0 |
|
committees/1/date |
2016-08-31T00:00:00
|
committees/1/rapporteur |
|
activities |
|
committees |
|
links |
|
other |
|
procedure |
|